chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy, Injection site erythema, Injection site induration, Injection site pruritus, Injection site rash
Clinical narrative: This spontaneous prospective pregnancy report was received from a female patient of unknown age, reporting on herself. Information regarding patient's medical history, concurrent condition, drug reactions/allergies and concomitant therapy was not provided. On 16-FEB-2016, the patient was vaccinated with a dose of MMR II. Other suspect therapies included (Merck) VARIVAX vaccinated on 19-FEB-2016. Patient reported that two weeks after receiving the MMR II and then (Merck) VARIVAX, i.e. approximately on 01-MAR-2016, she found out that she was 4 weeks pregnant in an unspecified way. LMP and EDD were calculated as 01-FEB-2016 and 07-NOV-2016, respectively. Patient also complained that she developed itching and rash on her upper left arm with redness and hardness at the injection site. But, it was unspecified whether the injection site was MMR II or (Merck) VARIVAX. The patient required medical attention and visited an unknown office. Outcome of the injection site reactions were unknown. Causality assessment was not provided. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Pregnancy test positive
Clinical narrative: This spontaneous prospective pregnancy report was received from a female patient of unknown age, reporting on herself. Information regarding patient's medical history, concurrent condition, drug reactions/allergies and concomitant therapy was not provided. On 16-FEB-2016, the patient was vaccinated with a dose of MMR II. Other suspect therapies included (Merck) VARIVAX vaccinated on 19-FEB-2016. Patient reported that two weeks after receiving the MMR II and then (Merck) VARIVAX, i.e. approximately on 01-MAR-2016, she found out that she was 4 weeks pregnant in an unspecified way. LMP and EDD were calculated as 01-FEB-2016 and 07-NOV-2016, respectively. Patient also complained that she developed itching and rash on her upper left arm with redness and hardness at the injection site. But, it was unspecified whether the injection site was MMR II or (Merck) VARIVAX. The patient required medical attention and visited an unknown office. Outcome of the injection site reactions were unknown. Causality assessment was not provided. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Influenza like illness, Injection site pain, Periarthritis
Clinical narrative: This spontaneous report was received from a 60 year old female patient (reported as currently 70 year old). No medical history and concurrent conditions were reported. The patient's drug reactions/allergy included topical dermatitis to few unspecified cosmetics and epinephrine. Approximately in August 2006 (reported as fall 2006), the patient was vaccinated with PNEUMOVAX 23, 1 normal shot, in the left arm as it was precautionary at 60 years age and an unspecified flu shot in her right arm. The patient did not experience injection site reaction in the right arm but a half hour after receiving PNEUMOVAX 23, the patient developed injection site pain and flu like symptoms, approximately in August 2006 (reported as fall 2006). The next morning the patient went to see her physician and received treatment with three rounds of prednisone (unspecified dose) orally to make her feel better. The patient was also instructed to start physical therapy to help with her frozen shoulder. No lab diagnostic tests were performed. The outcome of the events was reported as recovered/resolved. Causality assessment was not provided. No product quality issue was involved. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: This spontaneous report as received from a nurse via a company representative refers to two patients of unknown age and gender. Pertinent medical history and drug reactions/allergies were not reported. On unknown dates the patients were vaccinated with 1 shot of PNEUMOVAX 23 (dose, lot# and expiration date were not reported) subcutaneously. Concomitant drug was not reported. On unknown dates the patients both experienced shooting pain that went down from the injections sites to their finger tips after the vaccination and sought unspecified medical attention. The patients' condition improved and PNEUMOVAX 23 was not reintroduced. The causality was not reported. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: This spontaneous report as received from a male nurse of unknown age via a company representative refers to himself. Pertinent medical history and drug reaction/allergies were not reported. On an unknown date the patient was vaccinated with 1 shot of PNEUMOVAX 23 (dose, lot # and expiration date were not reported) subcutaneously. Concomitant drug was not reported. On an unknown date the patient experienced shooting pain that went down from the injection site to finger tips after the vaccination and sought unspecified medical attention. The patient's condition improved and the PNEUMOVAX 23 was not reintroduced. The causality was not reported. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse (L.P.N.) concerning a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not provided. On 25-MAR-2016, the patient was vaccinated with a dose of PNEUMOVAX 23 (lot # K008927 with expiration date 17-MAR-2016, dose and route unspecified), which had been expired. No adverse effects were reported. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician via company representative referring to a male patient of unknown age. There was no concurrent condition or medical history reported. On an unknown date the patient was vaccinated with ZOSTAVAX (dosage, strength, route and lot # unknown) for prevention of shingles. There was no concomitant medication reported. While on ZOSTAVAX, the patient developed shingles. The patient visited the physician for medical attention. The outcome of the event was unknown. Additional information is not expected as the reporter did not wish further contact.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Pain in extremity, Peripheral swelling
Clinical narrative: Information has been received from a 60 year old female patient who had a heart attack previously, concerning herself. Her current conditions included breast cancer, hypertension, lymphoma, swelling, heart disorder, blood cholesterol abnormal, bronchitis and drug reactions/allergies to codeine and some type of penicillin. Approximately on 04-MAR-2016 (reported as about 3 weeks ago), the patient was vaccinated with ZOSTAVAX in the left arm (dose, route, lot# and expiration date were not reported) (medication error). Concomitant medications included amlodipine besylate, atenolol, atorvastatin calcium, ezetimibe (manufacturer unknown) (reported as "Eztimide"), furosemide (manufacturer unknown), potassium (for potassium replacement), albuterol and lisinopril (manufacturer unknown) (reported as "Lisinotril"). Approximately on 05-MAR-2016 (reported as the day after she received the ZOSTAVAX), her arm had blisters, and her arms and hands started swelling up. She also had pain in both her arms. No lab diagnostics studies were performed and no treatment was given for the events. The outcome of the events was not reported. Causality assessment was not reported. Additional information has been requested.
Age: 0.4
Sex: U
Vaccine: RV5
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 4 month old patient of unknown gender. The patient's pertinent medical history and drug reactions or allergies were not reported. On an unknown date, the patient was inadvertently vaccinated with the first dose of ROTATEQ (orally, lot # L035510 and expiration date 13-MAY-2017, dose was not reported) at the age of 4 months old. Concomitant therapy was not reported. No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to an unspecified number of unspecified patients of unknown age and gender. On unknown dates. the patients were vaccinated with doses of improperly stored ROTATEQ (lot # K013868, expiration date 22-MAY-2016, lot number # K022992, expiration date 27-MAY-2016, dose and route not provided). No adverse effects were reported. Temperature: 34.3F; Time frame: 1 hour; Data Logger; no; Was it administered (AE)? Yes; Was previous temperature excursion? No; Additional information has been requested.
Age: 1.6
Sex: M
Vaccine: DTAPHEPBIP, HEPA, HPV4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Information has been received from a physician referring to two 18 month old male twin patients. There was no medical history or drug reaction/allergies reported. On 24-MAR-2016, the two patients were inadvertently administered with GARDASIL (lot # L040459 with expired date 06-APR-2017, intramuscular, dose unknown) into their thighs. No concomitant therapy was reported. No adverse effect was reported. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy, Pregnancy test urine positive
Clinical narrative: This spontaneous prospective pregnancy report as received from a nurse practitioner refers to a 26 year old female patient. The patient has medical history of seizure disorder, The patient is a tobacco user. The patient had last menstrual period (LMP) of 03-NOV-2015. Estimated date of conception (EDC) was 17-NOV-2015. The patient underwent urine screen for pregnancy prior to vaccination and it was negative on 11-JAN-2016 and was vaccinated with first dose of GARDASIL 9 lot # L011846 expiry date 16-JUN-2017, intramuscularly. The patient did not have any concomitant medications. The patient was exposed to the vaccine in first trimester. Patient then returned to the office on 11-MAR-2016 for her second dose (which was not administered) and a urine screen was again performed at which time it came back as positive for pregnancy. The patient sought medical attention. The patient did not receive any further doses of the vaccine and nurse practitioner stated that the patient was referred to an unspecified OB/GYN for prenatal care. The patient had estimated delivery date of 09-AUG-2016. The pregnancy outcome is pending (present status reported as not recovered). There was no product quality complaint. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. Information about medical history and concurrent condition was unspecified. On 23-MAR-2016 the patient was vaccinated with improperly stored dose of PNEUMOVA 23 (lot # L040181, expiration date 18-APR-2017, dose unknown, intramuscular). The vaccine was stored under -0.4 degree centigrade (round to 0 degree centigrade) for a cumulative of 7 hours and 0.9 degree centigrade for a cumulative of 7 hours, 1.3 degree centigrade for 36 minutes, 1.4 degree centigrade for 1 hour, 1.6 degree centigrade for 42 minutes and 1.7 degree centigrade for 20 minutes. It was called because of a data logger. No adverse effects reported. Additional information has been requested.
Age: 2.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site infection, Injection site swelling, Injection site warmth, Irritability
Clinical narrative: Throwing up for 4 days cranky, running a fever, 10 days later infection to the injection site, swollen red and warm, Keflex was prescribed. 12 days later still red swollen and hot.
Age: 2.0
Sex: F
Vaccine: VARCEL
Symptoms: Pyrexia, Vomiting
Clinical narrative: Throwing up for 4 days cranky, running a fever, 10 days later infection to the injection site, swollen red and warm, Keflex was prescribed. 12 days later still red swollen and hot.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Skin plaque
Clinical narrative: Red, raised skin plaques on face scalp, neck, shoulders, arms, back of thighs, shin, top of feet. Cortisone cream to effected areas.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 16-MAR-2016, the patient was vaccinated with a dose of improperly stored VARIVAX (Merck) lot # reported as L042264, expiration date: 26-OCT-2017, 0.5 ml, subcutaneously. The vaccine was exposed to temperature of 46.8 Fahrenheit degrees for 6.5 hours. There was no previous temperature excursion. 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 a nurse refers to unknown number of patients of unknown gender and age. Information regarding patients' medical history, concurrent condition, drug reactions/allergies and concomitant medications were not provided. On unknown dates, these patients were inadvertently vaccinated with improperly stored VARIVAX (Merck) (lot # L037560, expiry date: 29-SEP-2017) (incorrect product storage). The vaccine underwent a temperature excursion to -6 degrees Celsius for a time frame of 8 hours 58 minutes. No adverse effects were reported. This is one of the two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to multiple unspecified patients of unknown age and gender. Information regarding the patients medical history and concurrent conditions were not provided. On unknown dates the patients were vaccinated with improperly stored ROTATEQ (Lot number-L022447, expiry date-26-FEB-2017), orally. No adverse effects were reported. No laboratory tests were reported. It was also reported that the temperature was 27C for a time frame of 29 hours and that there was no previous temperature excursion. No product quality complaint (PQC) was involved. No further information was provided. This is one of the two reports from the same reporter. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 16-MAR-2016, the patient was vaccinated with a dose of improperly stored PROQUAD (Merck) lot # L042818, expiration date: 26-APR-2017, 0.5 ml, subcutaneously. The vaccine was exposed to temperature of 46.8 Fahrenheit degrees for 16.5 hours. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: Patient reported that she got the shingles from the shingles vaccine.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain of skin, Rash papular
Clinical narrative: Patient reported that she got the shingles from the shingles vaccine.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to multiple unspecified patients of unknown age and gender. Information regarding the patients medical history and concurrent conditions were not provided. On unknown dates the patients were vaccinated with improperly stored M-M-R II (Lot number-L019989, expiry date-01-JUN-2017). No adverse effects were reported. No laboratory tests were reported. It was also reported that the temperature was 27C for a time frame of 29 hours and that there was no previous temperature excursion. No product quality complaint (PQC) was involved. No further information was provided. This is one of the two reports from the same reporter. Additional information has been requested.
Age: 16.0
Sex: M
Vaccine: HPVX
Symptoms: Eye movement disorder, Specialist consultation
Clinical narrative: Noticed left eyeballs looking at a wrong direction. From subtle to really pronounced non movement of eyeballs to directed path.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV9
Symptoms: Abdominal pain, Blood thyroid stimulating hormone, Differential white blood cell count, Full blood count, Headache
Clinical narrative: Sore throat, fever headache after receiving second dose of HPV, fever of 101.3, abdominal pain leg pain.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV9
Symptoms: Influenza virus test, Metabolic function test, Oropharyngeal pain, Pain in extremity, Pyrexia
Clinical narrative: Sore throat, fever headache after receiving second dose of HPV, fever of 101.3, abdominal pain leg pain.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV9
Symptoms: Streptococcus test
Clinical narrative: Sore throat, fever headache after receiving second dose of HPV, fever of 101.3, abdominal pain leg pain.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV9
Symptoms: Abdominal pain, Blood calcium decreased, Blood glucose normal, Blood thyroid stimulating hormone normal, Drug hypersensitivity
Clinical narrative: Sore throat, fever headache after receiving second dose of HPV, fever of 101.3, abdominal pain leg pain.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV9
Symptoms: Full blood count normal, Headache, Influenza virus test negative, Oropharyngeal pain, Pain in extremity
Clinical narrative: Sore throat, fever headache after receiving second dose of HPV, fever of 101.3, abdominal pain leg pain.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV9
Symptoms: Pharyngitis, Pyrexia, Streptococcus test negative
Clinical narrative: Sore throat, fever headache after receiving second dose of HPV, fever of 101.3, abdominal pain leg pain.
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative, Hypoaesthesia
Clinical narrative: This spontaneous report was received from an adult female physician reporting on herself. The patient's concurrent and historical conditions were not reported. On an unspecified date in 1985, the patient was vaccinated with RECOMBIVAX HB (lot number and expiration date were not provided), dose, route, anatomical location were not reported. There was not concomitant medication reported. On an unknown date, the patient stated that she had temporary issues with numbness. On an unknown date, the patient's Hepatitis B surface Ab was 6 (units not provided). On an unspecified date in 1990 her levels were good (values not specified). At the time of the report, the outcome of hypoaesthesia was unknown. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No medical history and concurrent conditions were reported. On 18-MAR-2016 the patient was vaccinated with an expired dose of ZOSTAVAX (expired product administered) (lot # L000447, expiry date 08-MAR-2016) subcutaneously (dosing regimen and frequency unknown). No concomitant medications were reported. No adverse effects were reported. The action taken with the therapy with ZOSTAVAX was unknown. The outcome of events was unknown. There was no product quality complaint reported. Additional information has been requested.
Age: 2.0
Sex: F
Vaccine: PPV
Symptoms: Band neutrophil percentage increased, Blood culture negative, C-reactive protein increased, Febrile convulsion, Injection site erythema
Clinical narrative: High fever (104.5 degree tympanic at home) then complex febrile seizure lasting 10-20 minutes. Stopped spontaneously. Hospitalized. Had large, erythematous, tender, indurated skin reaction at injection site with CRP 17.6, ESR 93. Treated with antibiotics, no confirmed infection.
Age: 2.0
Sex: F
Vaccine: PPV
Symptoms: Injection site induration, Injection site pain, Neutrophil percentage, Pyrexia, Red blood cell sedimentation rate increased
Clinical narrative: High fever (104.5 degree tympanic at home) then complex febrile seizure lasting 10-20 minutes. Stopped spontaneously. Hospitalized. Had large, erythematous, tender, indurated skin reaction at injection site with CRP 17.6, ESR 93. Treated with antibiotics, no confirmed infection.
Age: 2.0
Sex: F
Vaccine: PPV
Symptoms: White blood cell count increased
Clinical narrative: High fever (104.5 degree tympanic at home) then complex febrile seizure lasting 10-20 minutes. Stopped spontaneously. Hospitalized. Had large, erythematous, tender, indurated skin reaction at injection site with CRP 17.6, ESR 93. Treated with antibiotics, no confirmed infection.
Age: 25.0
Sex: F
Vaccine: HEP
Symptoms: Dysphonia, Pruritus, Swollen tongue
Clinical narrative: Hep B and TB skin test given 3/21/16 2:30 PM. 2:57 c/o itchiness to left arm. Ice applied. 3:15 c/o tongue swelling. EMS called. BENADRYL administered by EMS. 3:45 took by EMS to hospital. On way to hospital administered epinephrine since voice was changing. In ER for 6 hours. Refer to allergists. Epi prevention given.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site reaction, Injection site warmth, Skin lesion
Clinical narrative: Large, erythematous, indurated lesion lateral (L) upper arm surrounding injection site. Warm to touch. Given prednisone 2 tsp of 5/5mL x 4 days, with instruction to return if lesion spreads.
Age: 93.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Her arm (around injection site) got redness and swollen so her PCP gave her Prednisone 20 mg (1 po qd) x 7days.
Age: 1.03
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Blood electrolytes normal, Blood glucose normal, Febrile convulsion, Full blood count normal
Clinical narrative: Febrile seizure 3-23-16. Approx 10 minutes. Recovered spontaneously.
Age: 11.0
Sex: F
Vaccine: FLUN4, MNQ, TDAP
Symptoms: Blood glucose, Confusional state, Dysarthria, Dyskinesia, Glycosylated haemoglobin
Clinical narrative: Pt was sitting, conversing when suddenly pt head jerked back, hit head on wall, slumped to left convulsed 3-4 more times. Pt was moved to floor to raise legs up and resumed consciousness but had slurred speech, confusion. Got VS, Bld Glu and monitored, transported to ED for eval.
Age: 11.0
Sex: F
Vaccine: FLUN4, MNQ, TDAP
Symptoms: Head injury, Lipids, Liver function test, Loss of consciousness, Metabolic function test
Clinical narrative: Pt was sitting, conversing when suddenly pt head jerked back, hit head on wall, slumped to left convulsed 3-4 more times. Pt was moved to floor to raise legs up and resumed consciousness but had slurred speech, confusion. Got VS, Bld Glu and monitored, transported to ED for eval.
Age: 11.0
Sex: F
Vaccine: FLUN4, MNQ, TDAP
Symptoms: Seizure
Clinical narrative: Pt was sitting, conversing when suddenly pt head jerked back, hit head on wall, slumped to left convulsed 3-4 more times. Pt was moved to floor to raise legs up and resumed consciousness but had slurred speech, confusion. Got VS, Bld Glu and monitored, transported to ED for eval.
Age: 49.0
Sex: F
Vaccine: TYP, YF
Symptoms: Headache, Influenza virus test negative, Pain, Pyrexia
Clinical narrative: Patient given yellow fever vaccine 3-21-16 at 3:20 PM. Pt phoned me 3/23/16 stating think she was having reaction to vaccine states night before had fever, headache, body aches, when pt called stating sx not as bad as they were the night. Phoned pt 3-24-16 states she is much better.
Age: 22.0
Sex: F
Vaccine: VARCEL
Symptoms: Accidental exposure to product, Exposure via direct contact, Eye irritation
Clinical narrative: This spontaneous report was received from a nurse and refers to a 22 year old non-pregnant female patient with no drug reactions or allergies, who was also a nurse in the same office. The patient had no pertinent medical history. On 23-MAR-2016, the patient inadvertently splashed (Oka/Merck) VARIVAX in her eye (lot # reported as L045678, expiration date: 09-MAY-2017). There was no concomitant medication. On 23-MAR-2016, the patient experienced burning in the eye that came in contact with the (Oka/Merck) VARIVAX. The patient flushed her eye with water for 3 minutes and the burning improved. No lab diagnostic studies were performed. The outcome of the event of burning in the eye was reported as recovering. The relatedness between the event of burning in the eye and (Oka/Merck) VARIVAX was not reported. Additional information has been requested.
Age: 53.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Abdominal pain upper, Angina pectoris, Diarrhoea, Dysphagia, Dyspnoea
Clinical narrative: Initial unsolicited report received from a consumer on 18 March 2016. This case involves a female patient (age was not reported) who was vaccinated with a dose of INFLUENZA QUADRIVAL A-B VACCINE (Fluzone Quadrivalent) and DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (Adacel) (batch number, dose, expiration date, route and site  of administration was not reported for both the vaccines) in November 2014 (unspecified date). Patient's illness at time of vaccination was reported as not feeling well when she received vaccines and pre-existing physician diagnosed allergies, birth defects, medical conditions included allergies to thimerosal, eggs and statin drugs. Patient had diabetes, "fluid on her heart", hypothyroidism and elevated cholesterol. Concomitant medications were not reported. On an unspecified date, after the vaccination, the patient experienced vomiting, diarrhea and did not feel well. Patient was exhausted since receipt of vaccines. It was reported that since June, 2015 (unspecified date), patient had difficulty swallowing, had "heart pains", shortness of breath and had severe stomach ache. Patient required emergency room or doctor visit. Lab data and corrective treatment was not reported. The patient had not recovered from the above mentioned events. List of documents held by sender: none.
Age: 53.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Fatigue, Malaise, Vomiting
Clinical narrative: Initial unsolicited report received from a consumer on 18 March 2016. This case involves a female patient (age was not reported) who was vaccinated with a dose of INFLUENZA QUADRIVAL A-B VACCINE (Fluzone Quadrivalent) and DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (Adacel) (batch number, dose, expiration date, route and site  of administration was not reported for both the vaccines) in November 2014 (unspecified date). Patient's illness at time of vaccination was reported as not feeling well when she received vaccines and pre-existing physician diagnosed allergies, birth defects, medical conditions included allergies to thimerosal, eggs and statin drugs. Patient had diabetes, "fluid on her heart", hypothyroidism and elevated cholesterol. Concomitant medications were not reported. On an unspecified date, after the vaccination, the patient experienced vomiting, diarrhea and did not feel well. Patient was exhausted since receipt of vaccines. It was reported that since June, 2015 (unspecified date), patient had difficulty swallowing, had "heart pains", shortness of breath and had severe stomach ache. Patient required emergency room or doctor visit. Lab data and corrective treatment was not reported. The patient had not recovered from the above mentioned events. List of documents held by sender: none.
Age: 41.0
Sex: M
Vaccine: PPV
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Localized arm swelling and pain.
Age: 37.0
Sex: F
Vaccine: HPV9
Symptoms: Fatigue, Mass
Clinical narrative: Formed pea size lump under the skin that lasted 2 months.  Reports fatigue since vaccination.
Age: 1.08
Sex: F
Vaccine: DTAP, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Papule, Skin lesion, Urticaria
Clinical narrative: Initial small papules on shoulder, which progressed to hive-like lesions and then target lesions over entire body, with no mucosal involvement or fever.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On 16-MAR-2016, the patient was vaccinated with improperly stored PROQUAD (Merck) lot# L050909, expiry date: 14-JUN-2017 (dosing details, route and strength were not reported). It was reported that the vaccine was exposed to the temperature of 6F for a time frame of 15 hours. Previous temperature excursion was reported as 7F for 24 hours on 16-MAR-2016 and 10F for 24 hours on 11-MAR-2016. No adverse effects were reported. There were no product quality complaints (PQC) involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Lip swelling, Throat irritation, Urticaria, Vomiting
Clinical narrative: Pt reports hives on face that occurred 4 days post vaccines (TDAP, MENVEO, HPV) pt also with intermittent  lip swelling, vomiting and itching throat.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On 14-MAR-2016, the patient was vaccinated with improperly stored (Oka/Merck) VARIVAX lot#L025210, expiry date: 07-JUL-2017 (dosing details, route and strength were reported). It was reported that the vaccine was exposed to the temperature of 6F for a time frame of 15 hours. Previous temperature excursion was reported as 7F for 24 hours on 16-MAr-2016 and 10F for 24 hours on 11-MAR-2016. No adverse effects were reported. There were no product quality complaints (PQC) involved. 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 a patient of unknown age and gender. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On 14-MAR-2016, the patient was vaccinated with improperly stored PROQUAD (Merck) lot # L050909, expiry date: 14-JUN-2017, (dosing details, route and strength were not reported). It was reported that the vaccine was exposed to the temperature of 6F for a time frame of 15 hours. Previous temperature excursions were reported as 7F for 24 hours on 16-MAR-2016 and 10F for 24 hours on 11-MAR-2016. No adverse effects were reported. There were no product quality complaints (PQC) involved. 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 a patient of unknown age and gender. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On 14-MAR-2016, the patient was vaccinated with improperly stored PROQUAD (Merck) lot#L024123, expiry date: 30-DEC-2016 (dosing details, route and strength were not reported). It was reported that the vaccine was exposed to the temperature of 6F for a time frame of 15 hours. Previous temperature excursion was reported as 7F for 24 hours on 16-MAR-2016 and 10F for 24 hours on 11-MAR-2016. No adverse effects were reported. There were no product quality complaints (PQC) involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Cough, Decreased appetite, Dyspnoea, Headache, Influenza A virus test negative
Clinical narrative: Child developed sudden onset of fever and lethargy which lasted over one week.  Decreased appetite and cough. Headache and SOB.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Influenza B virus test, Lethargy, Pyrexia
Clinical narrative: Child developed sudden onset of fever and lethargy which lasted over one week.  Decreased appetite and cough. Headache and SOB.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Painful red area beneath where vaccine was given. Encompassing bicep area. Abx prescribed.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a registered nurse referring to an unspecified number of patients of unknown age and gender. The patients medical history and concomitant conditions were not reported. On an unknown date (reported as since 30-OCT-2015), the patients were vaccinated with inappropriately stored doses of VARIVAX (Merck) subcutaneous, lot # L013824 (expiration date 24-APR-2017) (dose, dose number and frequency were not provided). Concomitant medication were not reported. The reporter stated that these unspecified number of doses of VARIVAX (Merck) were stored at 5 degrees Celsius for 24 hours (incorrect product storage). No product quality complaint was reported. This is one of two reports from the same source. Additional information has been requested.
Age: 33.0
Sex: F
Vaccine: FLUC3
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Injection site swelling, pain, pruritus, erythema. Loratadine 10 mg every day, diphenhydramine 25 mg once.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Influenza like illness, Injection site pain, Pyrexia
Clinical narrative: Fever to 101, soreness at injection site with flu like symptoms that started 24hrs after injection.
Age: 66.0
Sex: M
Vaccine: FLUC3
Symptoms: Cough, Pharyngitis, Wheezing
Clinical narrative: Cough wheeze and pharyngitis.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Bursitis, Inflammation, Joint range of motion decreased, Pain, Rotator cuff syndrome
Clinical narrative: Severe pain, loss of range of motion. Shoulder treatments and eventual shoulder surgery (1-15-16) bursitis inflammation. Six months later still pain and limited range of motion.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Shoulder operation
Clinical narrative: Severe pain, loss of range of motion. Shoulder treatments and eventual shoulder surgery (1-15-16) bursitis inflammation. Six months later still pain and limited range of motion.
Age: 46.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Urticaria
Clinical narrative: RED WELTS AREA UNDER THE ARM OF THE INJECTION SITE, NOT AT THE INJECTION SITE.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Pain, Pain in extremity, Pyrexia, Rash
Clinical narrative: Right arm pain, bodyaches, rash, fever.
Age: 75.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site rash
Clinical narrative: Patient reported to us on 3/30/16 that he had injection site severe pain on 3/29/16. Upon observation of the site, the pharamacist noticed a small rash and redness around the injection site. Patient was not in pain when he reported the event.
Age: 41.0
Sex: F
Vaccine: FLU3, MNQ
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pain
Clinical narrative: L DELTOID SQ, REDNESS, SWELLING, AND HEAT TO THE AFFECTED AREA. A SIZE OF 60MM. TREATMENT: ADVISED PATIENT TO APPLY WARM COMPRESS, AND TAKE IBUPROFEN FOR PAIN AND SWELLING. IF THE PROBLEM PERSISTS PATIENT WAS ADVISED TO SEEK MEDICAL ATTENTION AT A PRIVATE SECTOR.
Age: 66.0
Sex: M
Vaccine: PNC13
Symptoms: Oropharyngeal pain, Swollen tongue
Clinical narrative: 6:30 PM Sore throat and tongue swelling.  No wheezing or increased shortness.  No hives, nausea, or vomiting.  Took Benadryl x 2 and symptoms improved.
Age: 0.33
Sex: F
Vaccine: DTAP, HIBV, RVX
Symptoms: Crying, Decreased appetite, Developmental delay, Encephalopathy, Infantile spasms
Clinical narrative: Non stop severe crying, low grade fever, no appetite, restlessness, seizures.
Age: 0.33
Sex: F
Vaccine: DTAP, HIBV, RVX
Symptoms: Pyrexia, Restlessness, Seizure
Clinical narrative: Non stop severe crying, low grade fever, no appetite, restlessness, seizures.
Age: 6.0
Sex: F
Vaccine: IPV, MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Pruritus generalised
Clinical narrative: Red at injection sites after injections. Evening of injections whole body itching, felt pain and burning at same time on back of left arm. Home from school on 2/17/16, back of arm very large hard and welled. Discussed concerns with Health Officer who advised to go to PCP and take Benadryl around the clock for 24 hours.
Age: 28.0
Sex: M
Vaccine: DTAP
Symptoms: Decreased appetite, Urticaria
Clinical narrative: Urticarial-like lesions over entire body.  Patient also noted a decrease in appetite.
Age: 52.0
Sex: M
Vaccine: DTP
Symptoms: Arthralgia, Chills, Headache, Muscle spasms, Nausea
Clinical narrative: Massive headache, joint pain, chills, fever, nausea, muscle cramps. Symptoms increase at night. 3 days so far.
Age: 52.0
Sex: M
Vaccine: DTP
Symptoms: Pyrexia
Clinical narrative: Massive headache, joint pain, chills, fever, nausea, muscle cramps. Symptoms increase at night. 3 days so far.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient is complaining of redness, swelling and warmth near injection site.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Injection site red, swollen, warm, and itchy.
Age: 0.5
Sex: F
Vaccine: HPV9
Symptoms: Exposure during breast feeding, Oral mucosal eruption, Rash
Clinical narrative: This spontaneous report was received from a female consumer reporting on her 6 month old baby daughter. The baby's relevant medical history, past drug history, and concomitant medications were unknown. On 24-MAR-2016, the mother received one dose of GARDASIL 9 (lot number, and expiration date were unknown) in her right arm (Dose number, frequency and indication were not provided). It was unknown if this was her first injection. Concomitant medication was not reported. The mother stated that her 6 month old baby daughter may had been exposed to GARDASIL 9 via breast milk because she continued to breastfeed the baby daughter after receiving the GARDASIL 9 injection. (MARRS case no. 1603USA013570). On the same day, the consumer noticed a very mild rash and oral mucosal eruption on her 6-month old daughter's mouth and neck. On 25-MAR-2016, the baby's rash was growing in size but the baby seemed normal otherwise. It was unknown if there were any relevant laboratory data. As of 25-MAR-2016, it was unknown if the baby would continue to be exposed to GARDASIL 9 via breast milk and she continued to have a rash on her mouth and neck. The reporter considered rash and oral mucosal eruption to be potentially medically significant events. This is one of two reports from the same source. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Contusion, Erythema
Clinical narrative: Bruising with a red ring around bruise.
Age: 23.0
Sex: F
Vaccine: MENB
Symptoms: Erythema, Pain, Skin warm, Tenderness
Clinical narrative: Soreness, tender, red, warm. TYLENOL, ice TID. Is on doxycycline for acne.
Age: 1.0
Sex: F
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse, and refers to a 12 months old female patient. The patient's medical history, concurrent conditions and drug reactions/allergies were not reported. On 26-MAR-2016, the patient was vaccinated at the same time with a dose of VARIVAX (Merck) (dose, frequency, route, lot # and expiration date were not reported) and a dose of PROQUAD (Merck) (dose, frequency, route, lot # and expiration date were not reported). No concomitant medications were reported. No adverse effects were reported. No product quality complaint was involved. Additional information is not expected as the reporter did not allow to be contacted.
Age: 5.0
Sex: M
Vaccine: PPV
Symptoms: Body temperature decreased, Erythema, Influenza virus test negative, Local reaction, Local swelling
Clinical narrative: Pt started with fever and local reaction next day. Temp increased 105 on 3/5/16. Local swelling , erythema and pain at vaccination site -> ->. Pt seen in office then temp decreased 96 at nite and pt taken to ER. vs stable but due to increased erythema pt placed on BACTRIM po. Erythema and pain slowly resolved over approximately 7-10 days.
Age: 5.0
Sex: M
Vaccine: PPV
Symptoms: Pyrexia, Streptococcus test negative, Vaccination site pain
Clinical narrative: Pt started with fever and local reaction next day. Temp increased 105 on 3/5/16. Local swelling , erythema and pain at vaccination site -> ->. Pt seen in office then temp decreased 96 at nite and pt taken to ER. vs stable but due to increased erythema pt placed on BACTRIM po. Erythema and pain slowly resolved over approximately 7-10 days.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a pharmacist and concerns an unspecified number of patients of unknown age and gender. The patients' medical history and concurrent conditions were unknown. It was reported that the unspecified number of patients received improperly stored doses of M-M-R II lot number K014832, expiry date 14-SEP-2016; lot number K009957, expiry date 14-JUL-2016; lot K004948, expiry date 04-APR-2016; lot number K014833, expiry date 14-SEP-2016 (dose and route were not reported) after 23-JUN-2015. It was reported that the vaccine was at 48 Fahrenheit of temperature and its time frame was 1 hour and 33 minutes, there was not previous excursion. No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested. This is one of several reports received from the same source.
Age: 1.06
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Injection site urticaria
Clinical narrative: Welt on (R) and (L) arm after vaccine administration.
Age: 75.0
Sex: M
Vaccine: PNC13, PNC13
Symptoms: Pruritus, Rash
Clinical narrative: Rash all over trunk and back itches sometimes lasting since one week after vaccine to date.
Age: 75.0
Sex: M
Vaccine: PNC13, PNC13
Symptoms: Erythema, Injection site pain, Urticaria
Clinical narrative: Rash all over trunk and back itches sometimes lasting since one week after vaccine to date.
Age: 57.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site rash
Clinical narrative: Patient reported redness, pain, itching, rash at proximity to injection site on (L) arm 24 hours after injection, so she sought treatment (type unknown) at urgent care clinic.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician referring to multiple unspecified patients of unknown age and gender. The patients' pertinent medical history and concurrent conditions were not reported. On an unknown date, the patients' were vaccinated with improperly stored doses of ROTATEQ oral lot # K013868 expiration date 27-MAY-2016 (strength and dose were not provided). The patients' concomitant medications were not provided. The physician stated, he needs to check his records to see if any were administered, but he "believed some were administered". The physician reported the following temperature excursion for the administered vaccines: 30.2 F for 4 hours, 31.1 F for 10 hours, 34.5 F for 10 hour and 34.6 F for 10 hours (cumulative time out of range was 34 hours). No previous temperature excursion was reported. At the time of the report, no adverse effects were reported and no product quality issue was involved. Additional information has been requested. This is one of two reports received from the same reporter.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician referring to multiple unspecified patients of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not provided. On an unknown date, the patients' were vaccinated with improperly stored doses of GARDASIL 9 lot # L016429 expiration date 09-AUG-2017 (strength, dose and route of administration were not provided). The patient's concomitant medications were not provided. The physician stated, he needs to check his records to see if any were administered, but he "believed some were administered". The physician reported the following temperature excursion for the administered vaccine: 30.2 degrees F for 4 hours, 31.1 degrees F for 10 hours, 34.5 degrees F for 10 hours and 34.6 degrees F for 10 hours (cumulative time out of range was 34 hours). No previous temperature excursion was reported. At the time of the report, no adverse effects were reported and no product quality issue was involved. Additional information has been requested. This is one of two reports received from the same reporter.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pruritus, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report was received from a 61 year old female patient. The patient's concurrent conditions included high blood pressure and allergy to latex and penicillin. The patient's medical history and concomitant medications were not provided. On 18-MAR-2016, the patient was vaccinated with ZOSTAVAX 1 shot (lot number, expiry date, route, dose and frequency were not reported) for shingles prevention. On 18-MAR-2016, after vaccination, the patient experienced injection site swelling about the size of a quarter, that increased to the size of a silver dollar. On 19-MAR-2016 (reported as on the next day), it was reported that the injection site was itchy and had a rash. The patient sought medical attention on 20-MAR-2016, when the swelling reached her shoulder area. The area was hot. The patient received a treatment with BENADRYL and camphor, methol, SARNA CREAM for the reported adverse events. No product quality complaint (PQC) was involved. At the time of this report, the outcome of injection site swelling, peripheral swelling, feeling hot, rash pruritic and Injection site pain was reported as not recovered. The reporter did not provide causality assessment between the reported events and the ZOSTAVAX. Additional information has been requested.