chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant (CMA) concerning an unspecified number of patients (gender and age unspecified) which reported that the patients received improperly doses of GARDASIL (dose, route and lot # unspecified) between 16-JUN-2014 and 13-JUL-2014. No adverse symptoms reported. This is one of several reports from the same source.  Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect dose administered
Clinical narrative: This spontaneous report was received from a health professional, refers to a patient of unknown age. On an unknown date approximately 6 months ago, the patient was vaccinated with PNEUMOVAX 23, intramuscular. On 17-JUL-2014 the patient received a second dose of PNEUMOVAX 23. It was reported by the Medical assistant, that the first dose of PNEUMOVAX was 'never documented on patient's chart that is how patient received a second dose'. Medical Assistant also reported that on 17-JUL-2014, it was documented that dose administered was 1 ml, intramuscularly in left arm in patient's chart. The dose was confirmed twice with Medical Assistant as 1ml, not 0.5 ml for does on 17-JUL-2014. The outcome of dose administered was 1 ml on 17-JUL-2014 and dose administered approximately 6 months ago is unknown. No other information was reported. Additional information is not expected.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a respiratory therapist refers to a one among 23 unspecified patients, age and gender were unknown. Medical history was not reported. The respiratory therapist informed that between 01-FEB-2014 through 31-MAY-2014 the patient was vaccinated with PNEUMOVAX 23, lot number T015866 expiration date 25-FEB-2015 (route, strength and dosage were not reported), which was improperly stored. Concomitant therapy was not reported. No adverse effects were reported. No product quality complaint (PQC) filed. The action taken was assessed as not applicable. The causality was assessed as not related to the suspect therapy. This is one of several reports received from the same reproter. Follow up information has been received. Lot number T015866 is an invalid lot numbers for PNEUMOVAX 23. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified patients of unknown age and gender. On an unknown date these unspecified patients were vaccinated with 5 doses of VARIVAX (Merck) (lot#, dose, route not reported) that had been improperly stored. No adverse effects were reported. This is one of several reports received from the same reporter (other MARRS # 1408USA006849). Additional information is not expected because the reporter did not want to be contacted.
Age: 12.0
Sex: F
Vaccine: HIBV, HPV4
Symptoms: Seizure like phenomena, Syncope
Clinical narrative: This spontaneous report as received from a consumer, who is the mother of the patient, refers to a 12 year old female patient. Current conditions were not reported. The patient's medical history included fainting during her 5 year vaccinations, approximately in 2006 or 2007 (specific dates and products unknown). On 06-AUG-2014 the patient was vaccinated with GARDASIL (intramuscular injection, 1 single shot, strength, anatomical location, lot # and expiration date not reported). Other suspect therapies included hemophilus B conjugate vaccine (meningococcal protein conjugale) (manufacturer unknown) (intramuscular, formulation, dose, strength, lot# and expiration date not reported). Concomitant medications were not reported. The reporter informed that on 06-AUG-2013, the patient fainted with seizure like movements after being vaccinated with GARDASIL. The reporter also stated that minutes before, the patient was vaccinated with hemophilus B conjugate vaccine (meningococcal protein conjugate) (manufacturer unknown). The patient sought medical attention, however, no treatment was given for the events. No laboratory diagnostics studies were performed. The patient recovered from the events on 06-AUG-2014. Causality assessment was not provided by the reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On an unknown date in August 2013 the patient received a first dose of GARDASIL (intramuscular, dose unknown) (reported as GARDASIL INJ 120Y). Pertinent medical history and concomitant medications were unspecified by the reporter. The reporter stated that the patient now (approximately in August 2014) wants to received a second dose. No adverse symptoms reported. The outcome of the events was unknown. No further information provided. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a consumer via company representative, regarding her daughter of unknown age. The patient's medical history, drug reactions or allergies were not provided. On an unknown date, the patient was vaccinated with a dose of VARIVAX (Merck) (dose and lot number were not provided). On an unknown date, the patient was diagnosed with the chicken pox, after receiving VARIVAX (Merck). On an unknown date, the patient recovered from chicken pox. Additional information is not expected.
Age: 18.0
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 18 year old patient of unknown ender. No pertinent medical history or drug reactions/allergies were provided. The nurse reported that, on 12-AUG-2014, the patient was administered an expired dose of M-M-R II INJ (lot number not reported, expiration date reported as 27-JUL-2014, dose and route not provided). No adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. Information about concurrent medical conditions, concomitant medication and medical history was not provided. On 06-AUG-2014 the patient was vaccinated with a 0.5ml dose of (Oka/Merck) VARIVAX (lot# and dose number were not provided), which had undergone a temperature excursion, subcutaneously.  No adverse effect was reported. It was unknown if the patient sought medical attention or not. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a respiratory therapist refers to one among three unspecified patient, age and gender were unknown. Medical history was not reported. The respiratory therapist informed that between 01-FEB-2014 through 31-MAY-2014 the patient was vaccinated with GARDASIL 120Y, injection, lot number T007850 expiration date 07-APR-2016 (route, strength and dosage were not reported), which was improperly stored. Concomitant therapy was not reported. No adverse effects were reported. No product quality complaint (PQC) filed. The action taken was assessed as not applicable. The causality was assessed as not related to the suspect therapy. Follow up information has been received. Lot number T007850 is an invalid lot numbers for GARDASIL.  This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a respiratory therapist refers to a one among 23 unspecified patients, age and gender were unknown. Medical history was not reported. The respiratory therapist informed that between 01-FEB-2014 through 31-MAY-2014 the patient was vaccinated with PNEUMOVAX 23, lot number, H003390 expiration date 16-JUL-2014 (route, strength and dosage were not reported), which was improperly stored. Concomitant therapy was not reported. No adverse effects were reported. No product quality complaint (PQC) filed. The action taken was assessed as not applicable. The causality was assessed as not related to the suspect therapy. This is one of several reports received from the same reporter. Follow up information has been received. Lot number H002280 is an invalid lot numbers for PNEUMOVAX 23. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a respiratory therapist refers to one among three unspecified patient, age and gender were unknown. Medical history was not reported. The respiratory therapist informed that between 01-FEB-2014 through 31-MAY-2014 the patient was vaccinated with GARDASIL 120Y, injection, lot number T005679 expiration date 27-NOV-2015 (route, strength and dosage were not reported), which was improperly stored. Concomitant therapy was not reported. No adverse effects were reported. No product quality complaint (PQC) filed. The action taken was assessed as not applicable. The causality was assessed as not related to the suspect therapy. Follow up information has been received. Lot number T005679 is an invalid lot numbers for GARDASIL.  This is one of several reports received from the same reporter. Additional information has been requested.
Age: 41.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Pain, Rash, Swelling
Clinical narrative: Skin rash and redness, swelling, pain.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Myalgia
Clinical narrative: This spontaneous report was received from a nurse practitioner refers to a 22 year old female patient. On 31-OCT-2013, the patient was vaccinated with GARDASIL, dose 2, 0.5ml, intramuscular. Concomitant therapy included "birth control pills" (unspecified name, dose and frequency). On an unknown date, the patient experienced dizziness and muscle aches after receiving the second dose of GARDASIL. The patient did not received treatment for the adverse event. The outcome of dizziness and muscle aches was unknown. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a respiratory therapist refers to a one among 23 unspecified patients, age and gender were unknown. Medical history was not reported. The respiratory therapist informed that between 01-FEB-2014 through 31-MAY-2014 the patient was vaccinated with PNEUMOVAX 23, lot number, T004196 expiration date 06-DEC-2014 (route, strength and dosage were not reported), which was improperly stored. Concomitant therapy was not reported. No adverse effects were reported. No product quality (PQC) filed. The action taken was assessed as not applicable. The causality was assessed as not related to the suspect therapy.  This is one of several reports received from the same reporter. Follow up information has been received. Lot number T004196 is an invalid lot number PNEUMOVAX 23. Additional information has been requested.
Sex: U
Vaccine: RUB
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a health care professional refers to a patient of unknown age and gender who on 11-AUG-2014, was vaccinated with ROTATEQ, 2 ml, orally. The healthcare worker, reported that ROTATEQ that underwent a temperature excursion has been administered. No adverse effect reported. No further information was provided. The outcome of ROTATEQ that underwent a temperature excursion has been administered was unknown. The reporter considered incorrect product storage to be not related to ROTATEQ. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare professional refers to a patient of unknown age and gender who on 11-AUG-2014, was vaccinated with GARDASIL, 0.5ml, intramuscular. The healthcare worker, reported that GARDASIL that underwent a temperature excursion has been administered. No adverse effect reported. No further information was provided. The outcome of GARDASIL that underwent a temperature excursion has been administered was unknown. The reporter considered incorrect storage to be not related to GARDASIL. This is one of several reports from same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare professional refers to a patient of unknown age and gender who on 08-AUG-2014, was vaccinated with GARDASIL, 0.5 ml, intramuscular. The healthcare worker, reported that GARDASIL that underwent a temperature excursion has been administered. No adverse effect reported. No further information was provided. The outcome of GARDASIL that underwent a temperature excursion has been administered was unknown. The reporter considered incorrect product storage to be not related to GARDASIL. This is one of several reports from the same source. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Arthralgia, Blood test, Injection site pain, Injection site swelling, Musculoskeletal stiffness
Clinical narrative: This spontaneous report as received from a 65 year old female consumer regarding herself as a patient with pain medication allergy and anesthesia allergy. There was no pertinent medical history. On 08-MAY-2014, while the patient was hospitalized having left knee replacement surgery she received PNEUMOVAX23, first dose (lot, dose and route not reported). On 25-JUN-2014, the patient visited her physician who checked the hospital records and said that she had not received the PNEUMOVAX23 while in hospital. She received it again that day (second dose, route reported as injection) (lot and dose not reported). Other suspect therapy included pravastatin (manufacturer unknown), patient was previously taking it. Concomitant therapies included lisinopril (manufacturer unknown) and vitamins (unspecified).  But the patient called the hospital and they confirmed that it was administered on 08-MAY-2014. On the evening of 25-JUN-2014, the patient began to experience joint pain and headache pain especially in the back of her head. A few days later these pains were more severe. Since then they have lessened but they do recur from time to time. The patient sought for medical attention (doctor visit). Blood work and Lyme test were performed without provided. Pravastatin (manufacturer unknown) was discontinued in conjunction with these issues (reported as treatment given: Yes). She felt no adverse effects after the first dose of PNEUMOVAX23. The outcome of joint pain and headache pain especially in the back of her head was reported as not recovered. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Nausea
Clinical narrative: This spontaneous report as received from a 65 year old female consumer regarding herself as a patient with pain medication allergy and anesthesia allergy. There was no pertinent medical history. On 08-MAY-2014, while the patient was hospitalized having left knee replacement surgery she received PNEUMOVAX23, first dose (lot, dose and route not reported). On 25-JUN-2014, the patient visited her physician who checked the hospital records and said that she had not received the PNEUMOVAX23 while in hospital. She received it again that day (second dose, route reported as injection) (lot and dose not reported). Other suspect therapy included pravastatin (manufacturer unknown), patient was previously taking it. Concomitant therapies included lisinopril (manufacturer unknown) and vitamins (unspecified).  But the patient called the hospital and they confirmed that it was administered on 08-MAY-2014. On the evening of 25-JUN-2014, the patient began to experience joint pain and headache pain especially in the back of her head. A few days later these pains were more severe. Since then they have lessened but they do recur from time to time. The patient sought for medical attention (doctor visit). Blood work and Lyme test were performed without provided. Pravastatin (manufacturer unknown) was discontinued in conjunction with these issues (reported as treatment given: Yes). She felt no adverse effects after the first dose of PNEUMOVAX23. The outcome of joint pain and headache pain especially in the back of her head was reported as not recovered. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Arthralgia, Blood test, Borrelia test, Headache, Incorrect dose administered
Clinical narrative: This spontaneous report as received from a 65 year old female consumer regarding herself as a patient with pain medication allergy and anesthesia allergy. There was no pertinent medical history. On 08-MAY-2014, while the patient was hospitalized having left knee replacement surgery she received PNEUMOVAX23, first dose (lot, dose and route not reported). On 25-JUN-2014, the patient visited her physician who checked the hospital records and said that she had not received the PNEUMOVAX23 while in hospital. She received it again that day (second dose, route reported as injection) (lot and dose not reported). Other suspect therapy included pravastatin (manufacturer unknown), patient was previously taking it. Concomitant therapies included lisinopril (manufacturer unknown) and vitamins (unspecified).  But the patient called the hospital and they confirmed that it was administered on 08-MAY-2014. On the evening of 25-JUN-2014, the patient began to experience joint pain and headache pain especially in the back of her head. A few days later these pains were more severe. Since then they have lessened but they do recur from time to time. The patient sought for medical attention (doctor visit). Blood work and Lyme test were performed without provided. Pravastatin (manufacturer unknown) was discontinued in conjunction with these issues (reported as treatment given: Yes). She felt no adverse effects after the first dose of PNEUMOVAX23. The outcome of joint pain and headache pain especially in the back of her head was reported as not recovered. Additional information has been requested.
Sex: F
Vaccine: HPV4, HEPA, HPV4, HEPA, HEPA, HPV4
Symptoms: Exposure during pregnancy, Human chorionic gonadotropin positive, No adverse event
Clinical narrative: This spontaneous prospective pregnancy report as received from a physician refers to a female patient of unknown age. The patient's medical history included one previous pregnancy. On 30-JUL-2014 the patient was vaccinated with GARDASIL. On the same date, the patient was also administered a dose of HAVRIX. The LMP and EDD were not known. At the time of the report the pregnancy outcome was pending. No treatment was given. Additional information has been requested.
Sex: F
Vaccine: HPV4, HEPA, HPV4, HEPA, HEPA, HPV4
Symptoms: Exposure during pregnancy, Human chorionic gonadotropin positive
Clinical narrative: This spontaneous prospective pregnancy report as received from a physician refers to a female patient of unknown age. The patient's medical history included one previous pregnancy. On 30-JUL-2014 the patient was vaccinated with GARDASIL. On the same date, the patient was also administered a dose of HAVRIX. The LMP and EDD were not known. At the time of the report the pregnancy outcome was pending. No treatment was given. Additional information has been requested.
Sex: F
Vaccine: HPV4, HEPA, HPV4, HEPA, HEPA, HPV4
Symptoms: Exposure during pregnancy
Clinical narrative: This spontaneous prospective pregnancy report as received from a physician refers to a female patient of unknown age. The patient's medical history included one previous pregnancy. On 30-JUL-2014 the patient was vaccinated with GARDASIL. On the same date, the patient was also administered a dose of HAVRIX. The LMP and EDD were not known. At the time of the report the pregnancy outcome was pending. No treatment was given. Additional information has been requested.
Sex: F
Vaccine: HPV4, HEPA, HPV4, HEPA, HEPA, HPV4
Symptoms: Exposure during pregnancy, Pregnancy test positive
Clinical narrative: This spontaneous prospective pregnancy report as received from a physician refers to a female patient of unknown age. The patient's medical history included one previous pregnancy. On 30-JUL-2014 the patient was vaccinated with GARDASIL. On the same date, the patient was also administered a dose of HAVRIX. The LMP and EDD were not known. At the time of the report the pregnancy outcome was pending. No treatment was given. Additional information has been requested.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. The patient's pertinent medical history, drug reactions/allergies were not provided. On 31-JUL-2014, the patient was vaccinated with a dose of ZOSTAVAX, (route not provided), Lot # K000726, expiration date in 09-JAN-2015. Co-suspect therapy and concomitant medications were not provided. The patient reported that on an unspecified date, after receipt the vaccine, in 2014, the patient called and stated to pharmacist that she had a red quarter sized area around injection site with a head in the middle, it was firm and warm to the touch. The reporter also noted that the patient stated that she has two rings around injection site. Reporter may have patient begin BENADRYL and will have her follow up with her primary care physician. At the time of the report, the patient's outcome and the relatedness between the events and suspect therapy were unknown. Additional information has been requested.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. The patient's pertinent medical history, drug reactions/allergies were not provided. On 31-JUL-2014, the patient was vaccinated with a dose of ZOSTAVAX, (route not provided), Lot # K000726, expiration date in 09-JAN-2015. Co-suspect therapy and concomitant medications were not provided. The patient reported that on an unspecified date, after receipt the vaccine, in 2014, the patient called and stated to pharmacist that she had a red quarter sized area around injection site with a head in the middle, it was firm and warm to the touch. The reporter also noted that the patient stated that she has two rings around injection site. Reporter may have patient begin BENADRYL and will have her follow up with her primary care physician. At the time of the report, the patient's outcome and the relatedness between the events and suspect therapy were unknown. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site cellulitis, Injection site erythema, Injection site urticaria, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 60 year old female patient. No information about medical history, drug reactions and allergies was specified. On 09-AUG-2014 the patient was vaccinated with ZOSTAVAX (lot# K003597; expiry date 12-MAR-2015, dose not reported), subcutaneously. No concomitant medications were reported. Pharmacist reported that since 09-AUG-2014, patient has come back to the pharmacy seeking medical attention and complaining of redness and warmth at the injection site. Pharmacist stated that after assessing the sites - patient looks as if she has cellulitis at the injection site. Pharmacist informed patient to contact her primary health care provider. There was no product quality complaint. No lab diagnostics studies were performed. The outcome of the events was reported as not recovered/not resolved. The causality was not specified. This is one of the two reports received from the same reporter (Marrs# 1408USA007657). Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site cellulitis, Injection site erythema, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 60 year old female patient. No information about medical history, drug reactions and allergies was specified. On 09-AUG-2014 the patient was vaccinated with ZOSTAVAX (lot# K003597; expiry date 12-MAR-2015, dose not reported), subcutaneously. No concomitant medications were reported. Pharmacist reported that since 09-AUG-2014, patient has come back to the pharmacy seeking medical attention and complaining of redness and warmth at the injection site. Pharmacist stated that after assessing the sites - patient looks as if she has cellulitis at the injection site. Pharmacist informed patient to contact her primary health care provider. There was no product quality complaint. No lab diagnostics studies were performed. The outcome of the events was reported as not recovered/not resolved. The causality was not specified. This is one of the two reports received from the same reporter (Marrs# 1408USA007657). Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site cellulitis, Injection site erythema, Injection site urticaria, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 60 year old female patient with prophylaxis. No information about medical history, drug reactions and allergies was specified. On 09-AUG-2014 the patient was vaccinated with ZOSTAVAX (lot# K003597; expiry date 12-MAR-2015, dose not reported), subcutaneously. No concomitant medications were reported. Pharmacist reported that since 09-AUG0-2014, patient has come back to the pharmacy seeking medical attention and complaining of redness and warmth at the injection site. Pharmacist stated that after assessing the sites - patient looks as if she has  cellulitis at the injection site. Pharmacist informed patient to contract her primary health care provider. There was no product quality complaint. No lab diagnostics studies were performed. The outcome of the events was reported as not recovered/no resolved. The causality was not specified. This is one of the two reports received from the same reporter (MARRS# 1408USA008519). Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site cellulitis, Injection site erythema, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 60 year old female patient with prophylaxis. No information about medical history, drug reactions and allergies was specified. On 09-AUG-2014 the patient was vaccinated with ZOSTAVAX (lot# K003597; expiry date 12-MAR-2015, dose not reported), subcutaneously. No concomitant medications were reported. Pharmacist reported that since 09-AUG0-2014, patient has come back to the pharmacy seeking medical attention and complaining of redness and warmth at the injection site. Pharmacist stated that after assessing the sites - patient looks as if she has  cellulitis at the injection site. Pharmacist informed patient to contract her primary health care provider. There was no product quality complaint. No lab diagnostics studies were performed. The outcome of the events was reported as not recovered/no resolved. The causality was not specified. This is one of the two reports received from the same reporter (MARRS# 1408USA008519). Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Immediate post-injection reaction, Injection site reaction, Mobility decreased, Pain, Pain in extremity
Clinical narrative: Immediate shooting pain and tingling down my arm, forearm and into my left pinky and ring finger. For the first few days, I could not move this shoulder, put weight on it or sleep on it. I experienced extreme soreness for over a month. I could not lift my arm to the side or rotate it back without pain for several weeks. Putting weight on the shoulder also hurt for more than a month. I sought out a massage therapist and physical therapist that worked on my shoulder, neck, forearm and hand. After about a month and a half, most of the symptoms seem to have disappeared.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Paraesthesia, Radial nerve injury, Weight bearing difficulty
Clinical narrative: Immediate shooting pain and tingling down my arm, forearm and into my left pinky and ring finger. For the first few days, I could not move this shoulder, put weight on it or sleep on it. I experienced extreme soreness for over a month. I could not lift my arm to the side or rotate it back without pain for several weeks. Putting weight on the shoulder also hurt for more than a month. I sought out a massage therapist and physical therapist that worked on my shoulder, neck, forearm and hand. After about a month and a half, most of the symptoms seem to have disappeared.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Pruritus
Clinical narrative: Pruritis of bilateral hands and feet as well as neck.
Age: 1.03
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Febrile convulsion, Rash generalised
Clinical narrative: Morning developed rash over entire body and face and by the afternoon had a Febrile Seizure.
Age: 16.0
Sex: F
Vaccine: MNQ, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Mother called - shots (MENACTRA and Varicella) were given on 8/01/14 in (L) arm. Mother states redness and swelling "(L) arm up to (L) shoulder that took 5 days to go away", mother states no fever or any other reaction - mother called PCP - instructed to give BENADRYL or CLARITIN. She gave CLARITIN.
Age: 18.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Pruritus, Rash
Clinical narrative: Noticed arms were itching, spread to trunk, back of legs and arms.
Age: 18.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Pruritus generalised
Clinical narrative: Noticed arms were itching, spread to trunk, back of legs and arms.
Age: 0.28
Sex: M
Vaccine: DTAPIPV, HIBV, PNC13, RV5
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: 3 month patient was vaccinated with Kinrix (DTaP-IPV) which is only approved for 4-6 years of age. Physician notified. No treatment was conducted, only monitoring.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: 1 wk after vaccine administration (7/18) patient developed shingles. Seen in clinic 8/5, treated with acyclovir.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness
Clinical narrative: Lightheaded, dizzy, approx 3 minutes. BP, HR WNL.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Pruritus, Rash
Clinical narrative: Developed a rapidly progress rash about 9 pm. Given BENADRYL at home - did not help - when involved face > pt c/o was itchy Mom took her to ER. Given another dose of BENADRYL without improving then ZANTAC then steroids. No improved while being observed and rash worsen. Given epinephrine and rash resolved observed x 4-6 hrs. Sent home on PO prednisone x 5 days. Symptoms recurred 7 days after initial rxn.
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Back pain, Blood test, Hypersensitivity, Injection site pain, Injection site swelling
Clinical narrative: Raised area and sore injection site followed by feeling very sick with lower back pain of pain scale of 7 - Dr. did blood panel confirming an allergic reaction pt still in pain. Pain scale of 3 now. Swollen lymph nodes.
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Lymphadenopathy, Malaise, Pain
Clinical narrative: Raised area and sore injection site followed by feeling very sick with lower back pain of pain scale of 7 - Dr. did blood panel confirming an allergic reaction pt still in pain. Pain scale of 3 now. Swollen lymph nodes.
Age: 32.0
Sex: M
Vaccine: HEP
Symptoms: Dizziness, Haematoma
Clinical narrative: Pt. received Hep B vaccine on 02Aug14 at 1430 in (L) arm. After administrating vaccine, a hematoma appeared within seconds. 1 minute later pt, stated "feeling dizzy." Applied ice on injection site and had pt. sit down.
Sex: M
Vaccine: PNC13
Symptoms: Antibody test negative, Blood immunoglobulin G decreased, Ear infection, Respiratory tract infection
Clinical narrative: This is a spontaneous report from a contactable consumer. This consumer reported for her son and stated that the son had received the full 4 dose series of PREVNAR 13, 0.5ml single dose on unknown date. The patient continued to get respiratory illnesses and ear infections. The doctor tested his antibodies and he did not produce any antibodies to the PREVNAR 13. He had a low IgG when he was one and a half and that had increased and was within range. The doctor told him that it was not unusual for the PREVNAR 13 not to stick. Any info on giving a 5th injection?
Age: 66.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Infection, Injected limb mobility decreased
Clinical narrative: Initial report was received on 07 August 2014 from a health care professional. A 66 year-old male patient had received on 16 January 2014 an intramuscular left deltoid injection of FLUZONE (Sanofi Pasteur Inc. lot number UH918AA) and an unspecified amount of time later, developed an "infection" and was hospitalized for two months (dates not reported). According to the reporter, the patient was advised by another pharmacist that he had an infection. The patient went to the emergency room but the physician diagnosed no infection. The patient went to a different hospital and was hospitalized for two months for reason unknown to the reporter. The patient also claimed that he had limited use of his left arm and had received rehabilitation to gain full use of his left arm. Treatments were not reported. Illness at the time of vaccination was denied by patient. The patient had received unspecified flu vaccine in the past, manufacturer and date was not reported. The patient's other past medical history was unknown. No further information was available at the time of the report. Outcome was unknown. Documents held by sender: none.
Age: 66.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Deformity, Local swelling, Movement disorder, Pain in extremity
Clinical narrative: Initial report was received on 07 August 2014 from a health care professional. A 66 year-old male patient had received on 16 January 2014 an intramuscular left deltoid injection of FLUZONE (Sanofi Pasteur Inc. lot number UH918AA) and an unspecified amount of time later, developed an "infection" and was hospitalized for two months (dates not reported). According to the reporter, the patient was advised by another pharmacist that he had an infection. The patient went to the emergency room but the physician diagnosed no infection. The patient went to a different hospital and was hospitalized for two months for reason unknown to the reporter. The patient also claimed that he had limited use of his left arm and had received rehabilitation to gain full use of his left arm. Treatments were not reported. Illness at the time of vaccination was denied by patient. The patient had received unspecified flu vaccine in the past, manufacturer and date was not reported. The patient's other past medical history was unknown. No further information was available at the time of the report. Outcome was unknown. Documents held by sender: none.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site rash, Rash, Urticaria
Clinical narrative: Urticarial rash to low back, face and arms.
Age: 18.0
Sex: F
Vaccine: MNQ, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness, swelling at inj. site < 24 hrs after vaccine. Advised topical antihistamine and/or oral if needed.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to 22 patients of unknown age and unknown gender. Pertinent medical history, drug reactions or allergies were not reported. On 2014, from 02-FEB-2014 to July 2014, the 22 patients were vaccinated (reported as could have been administered to 22 patients) with PROQUAD lot # J015595, expiration date 05-JUN-2015, that were exposed to highest temperature of 5 degrees C (reported as "5C") for 5 months (strength, dose and dose schedule were not reported). No concomitant therapies were reported. No adverse effects reported. The outcome of the events was unknown. Additional information has been requested.
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: FIRM AREA NOTED AT SITE OF INJECTION MEASURING 2 INCHES IN DIAMETER. AREA ALSO NOTED TO BE RED, TENDER, AND WARM.
Age: 19.0
Sex: F
Vaccine: VARCEL
Symptoms: Dizziness, Posture abnormal
Clinical narrative: 1405: pt. was found slumped in her chair in the waiting room.  She was escorted back into the patient care center where the vaccine was administered. She was placed in a chair where she was moving her head back and forth d/t her dizziness. 1414: Patient requested to lay down on the floor. 1420: patient requested to be escorted to the restroom.  RPH escorted her to the restroom.  Got halfway to the bathroom and she got down on her knees d/t feeling dizzy. She spent 15 minutes in the bathroom and at 1435 she went home. She claimed she felt better. The next day the RPH called the patient and she said she feels better.  Not dizzy any more nor did it return when she left the pharmacy the day before.
Age: 11.0
Sex: M
Vaccine: HEPA, HPV4, VARCEL
Symptoms: Fall, Head injury, Syncope
Clinical narrative: Fainting episode, child fell in waiting room following immunizations. Hit head, was easily aroused following incidence. No bruising or redness noted on head, trunk or extremities.  Sent home with mother in 20 min.
Age: 21.0
Sex: U
Vaccine: PPV
Symptoms: Local reaction, Myalgia, Pyrexia, Streptococcus test negative
Clinical narrative: Fever/myalgia/local reaction 3 hours after vaccie - at 24 hours; myalgia with temp = 102.8.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Pain in extremity
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to 3 patients of unknown age and genders. No patients' demographics, medical histories, concurrent conditions or concomitant medications were reported. On an unknown dates in August 2014 (also reported as "the week of 04-AUG-2015, she is unsure of the exact dates") the patients were vaccinated with doses of PNEUMOVAX23, 0.5 ml, intramuscularly, lot # J015868, expiration date 25-FEB-2015. It was reported that all three patients received PNEUMOVAX23 from the same lot. On approximately 07-AUG-2014 (reported as "around 07-AUG-2014, but she is unsure of exact dates") all patients reported the same reactions to the PNEUMOVAX23 vaccine. In August 2014 all three patients experienced pain in the entire injection arm, upper arm redness and swelling, measuring 20cm x 11 cm, which was hot to the touch. All three patients were feverish as well. The patients sought medical attention. The outcomes of the adverse reactions were unknown. Relatedness between use of PNEUMOVAX23 and the adverse events was not reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to 3 patients of unknown age and genders. No patients' demographics, medical histories, concurrent conditions or concomitant medications were reported. On an unknown dates in August 2014 (also reported as "the week of 04-AUG-2015, she is unsure of the exact dates") the patients were vaccinated with doses of PNEUMOVAX23, 0.5 ml, intramuscularly, lot # J015868, expiration date 25-FEB-2015. It was reported that all three patients received PNEUMOVAX23 from the same lot. On approximately 07-AUG-2014 (reported as "around 07-AUG-2014, but she is unsure of exact dates") all patients reported the same reactions to the PNEUMOVAX23 vaccine. In August 2014 all three patients experienced pain in the entire injection arm, upper arm redness and swelling, measuring 20cm x 11 cm, which was hot to the touch. All three patients were feverish as well. The patients sought medical attention. The outcomes of the adverse reactions were unknown. Relatedness between use of PNEUMOVAX23 and the adverse events was not reported. Additional information has been requested.
Age: 42.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: His whole left tricep is red and warm. Started small on 8-11-14 and has gotten bigger. He is going to a walk in clinic this morning after a dose of diphenhydramine.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous
Clinical narrative: Pt had approx 4 inch red raised rash with a white halo.
Age: 0.18
Sex: M
Vaccine: DTAP, HIBV, PNC13
Symptoms: Crying, Flatulence, Hypertonia, Insomnia
Clinical narrative: Frequent crying, gassiness, difficulty sleeping (wakes up every 5-15 minutes, increased tone (twisting and turning). Seen by collegue 7/15, noted to be fussy but consolable, normal tone.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Swelling, Tenderness
Clinical narrative: Swelling, redness and tenderness.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Ear congestion, Headache, Nausea, VIIth nerve paralysis
Clinical narrative: On evening of 10/6/13 had a headache, Rt. ear felt plugged. On 10/8/13 arrived about 5:30 pm to ER to have ear checked, feeling more nausea and dizzy. On 10/9/13 woke up with full facial paralyses of Rt. side. Went back to Dr. on 10/9/13. Full Bell's Palsy Rt. side face.
Age: 63.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Skin warm
Clinical narrative: (L) arm redness about 8 cm diam, warmth that started 5 days post injection.
Age: 18.0
Sex: M
Vaccine: MEN
Symptoms: Back pain, Headache, Nausea, Photophobia
Clinical narrative: Initial nausea in middle of the night, then woke up with bad headache and photophobia and back pain.
Age: 62.0
Sex: M
Vaccine: HEPAB, TDAP
Symptoms: Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: PAIN AND SWELLING TO INJECTION SITE. FEVER.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Herpes zoster, Rash, Staphylococcal infection, Varicella virus test positive
Clinical narrative: Herpes zoster diagnosis in two-dose varicella vaccine recipient. Rash was unilateral, one dermatome (left side of back). Diagnosed at Health Center by Dr. on 5/19/14. Onset date unknown. Treated with acyclovir.  Also infected with Staph. No pain noted.
Age: 5.0
Sex: M
Vaccine: MMRV, VARCEL
Symptoms: Decreased appetite, Ear infection, Feeling abnormal, Pyrexia, Somnolence
Clinical narrative: VOMITING, HIGH FEVER UP TO 103, JUST WANTED TO SLEEP, DAZED , EAR INFECTION, LOSS OF APPETITE INCLUDING FLUIDS.
Age: 5.0
Sex: M
Vaccine: MMRV, VARCEL
Symptoms: Vomiting
Clinical narrative: VOMITING, HIGH FEVER UP TO 103, JUST WANTED TO SLEEP, DAZED , EAR INFECTION, LOSS OF APPETITE INCLUDING FLUIDS.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site irritation
Clinical narrative: Redness, irritation on left thigh 5 in by 3.75 in. Pt. examined 2 days after given Varicella given antihistamine for treatment.
Age: 1.0
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 12 months old patient who on 21-JUL-2014, the patient was vaccinated with a dose of VARIVAX (Merck) (lot number reported as J012816, Exp. Date: 10-OCT-2015 and J009986, Exp. Date: 12-AUG-2015) .5 ml, subcutaneous and a dose of M-M-R II (lot numbers reported as J002866, Exp. Date: 12-MAR-2015 and J008154 Exp. Date: 08-JUL-2015) that were improperly stored. Doses and routes were not reported. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: UNK
Symptoms: Arthralgia, Injection site pain, Pain in extremity
Clinical narrative: 8/12 - Arm achey, (L) - injection site. 8/13 - pain down (L) leg and (L) knee joint pain (L) calf pain (no fever, CP, SOB, behavior changes). 8/14 - 1041 am - mom called with pts above symptoms, advised to go to PCP/call PCP and go to ER/call 911 with only chest pain or shortness of breath.
Sex: U
Vaccine: HPV4
Symptoms: Neoplasm malignant
Clinical narrative: This spontaneous report as received from a physician via company representative refers to an unspecified patient of unknown age and gender. The physician reported that an unspecified patient informed her about having read on an unspecified article that another unspecified patient on an unknown date was vaccinated with GARDASIL (Injection, strength, route, anatomical location, dose number, lot # and expiration date not reported). Concomitant therapies were not reported. According to the patient who reported to the physician, the article stated that the GARDASIL caused an unspecified cancer in the unspecified individual on an unspecified date. The outcome of this event was unknown. Causality was not provided by the reporter. Upon internal review, "cancer" was considered as medically significant event. Additional information is not expected because the reporting physician did not consent for further follow up.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a certified medical assistant concerning an unspecified amount of patients. On unknown date the patients were vaccinated subcutaneously with 0.5 ml doses of (Oka/Merck) VARIVAX, that underwent temperature excursions. No adverse effect was reported.  Additional information has been requested.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to unspecified patients of unknown age and gender. The reported stated that on an unknown date the unspecified patients received improperly stored (Oka/Merck) VARIVAX (lot # J013728 exp. Date: 30-OCT-2015 and lot # J009992 exp. Date: 12-AUG-2015, dose, route, indication not reported) and (Oka/Merck) PROQUAD (captured in MARRS # 1408USA008610) which were exposed to a maximum temperature of -9C on multiple occasions, for undetermined timeframe (also reported that both vaccines were exposed to only -8.9C for only 15 hours. No adverse effects were reported. No Product Quality Complain (PQC) reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 34.0
Sex: F
Vaccine: MMR, TD
Symptoms: Exposure during pregnancy, Pregnancy test positive
Clinical narrative: Pt. had a positive pregnancy test on 08/04/2014. LMP of 06/07/2014 and probable date of conception 06/21/2014.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash, Varicella virus test positive
Clinical narrative: Herpes zoster diagnosis in previously vaccinated individual (Zostavax). Diagnosed on 05/02/2014. Painful unilateral rash on one dermatome. Treated with antiviral (unknown name).
Age: 1.39
Sex: F
Vaccine: DTAPHEPBIP, HEPA, MMRV, PNC13
Symptoms: Injection site induration, Injection site mass
Clinical narrative: Pt father states the "lump" was visible on the left thigh on the day of the injection. It has stayed the same size per pt. father from 5/13/14 to today 8/14/14. The site is hard to the touch and approximately the size of a quarter. It is not red, irritated or warm to the touch. This is the first time the pt has returned to the clinic since the immunizations were given on 5/13/14 and the first time the site has been observed by medical personnel.