chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: DTAP
Symptoms: Rhinorrhoea, Syringe issue
Clinical narrative: This case was reported by a nurse and described the occurrence of burning sensation in eye in a female patient who received INFANRIX (batch number F43Z7, expiry date 31st October 2015). On 28th October 2014 09:30, the patient received INFANRIX .5 ml. On 28th October 2014, an unknown time after receiving INFANRIX, the patient experienced inadvertent exposure to vaccine. On 28th October 2014 09:32, the patient experienced burning sensation in eye, headache, nasal discharge and pain. On 28th October 2014, the outcome of the burning sensation in eye, headache, nasal discharge and pain were recovered/resolved. On an unknown date, the outcome of the inadvertent exposure to vaccine was unknown. It was unknown if the reporter considered the burning sensation in eye, headache, nasal discharge and pain to be related to INFANRIX. Additional information received: Per HCP, while RN was administering INFANRIX vaccine, the needle and syringe came apart causing the liquid portion of the vaccine to come in contact with right eye. RN reported right eye began to burn and become achey within 2-3 mins after the event. Shortly after then started with a headache and right nasal drainage. RN stated she removed her right eye contact lens, flushed her right eye with saline. Per RN all symptoms resolved completely within an hour of the occurrence.
Sex: U
Vaccine: DTAPHEPBIP, TDAP
Symptoms: Incorrect product storage
Clinical narrative: This case was reported by a nurse and described the occurrence of incorrect storage of drug in a patient who received PEDIARIX. Co-suspect products included BOOSTRIX. On an unknown date, the patient received PEDIARIX at an unknown dose and BOOSTRIX at an unknown dose. On an unknown date, am unknown time after receiving PEDIARIX and BOOSTRIX, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage was unknown. Additional information received: Patients were possibly vaccinated with PEDIARIX and BOOSTRIX that was deemed unusable because of a possible temperature excursion.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a patient of unknown age and gender. Concomitant medication and current conditions were not reported. On 04-DEC-2014, the patient was vaccinated with an improperly stored dose of PEDVAXHIB (dose, route, lot number and expiration date were not reported). Concomitant medication was not provided. No adverse effects reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Medical history and current conditions were not reported. On 09-DEC-2014, the patient was vaccinated with an improperly stored dose of ZOSTAVAX (route, lot number and expiration date were not reported). Concomitant medication was not reported. No adverse effect reproted. 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 Licensed Practical Nurse refers to an unspecified number of patients of unknown age and gender. Concomitant medication and current conditions were not reported. On an unknown date, the patients were vaccinated with an improperly stored dose of PROQUAD (Merck) (route not reported), lot number reported as: K008872 and expiration date: 19-DEC-2015). Concomitant medication was not provided. No adverse effects reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from another healthcare professional refers to an unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with an improperly stored dose of RECOMBIVAX HB (strength, dose, route of administration and lot # were not reported). No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV, PPV, PPV
Symptoms: Adverse reaction
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a patient of unknown age and gender. Medical history and current conditions were not reported. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX 23 (route, lot number and expiration date were not reported). Concomitant medication was not provided. On an unknown date the patient reacted funny after receiving PNEUMOVAX 23. The outcome of "reacted funny like this to " was unknown. This is one of two reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV, PPV, PPV
Symptoms: Arthropathy, Blood pressure increased, Condition aggravated, Erythema, Musculoskeletal stiffness
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a patient of unknown age and gender. Medical history and current conditions were not reported. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX 23 (route, lot number and expiration date were not reported). Concomitant medication was not provided. On an unknown date the patient reacted funny after receiving PNEUMOVAX 23. The outcome of "reacted funny like this to " was unknown. This is one of two reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV, PPV, PPV
Symptoms: Pain in extremity, Rash
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a patient of unknown age and gender. Medical history and current conditions were not reported. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX 23 (route, lot number and expiration date were not reported). Concomitant medication was not provided. On an unknown date the patient reacted funny after receiving PNEUMOVAX 23. The outcome of "reacted funny like this to " was unknown. This is one of two reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV, PPV, PPV
Symptoms: Vaccination complication
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a patient of unknown age and gender. Medical history and current conditions were not reported. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX 23 (route, lot number and expiration date were not reported). Concomitant medication was not provided. On an unknown date the patient reacted funny after receiving PNEUMOVAX 23. The outcome of "reacted funny like this to " was unknown. This is one of two reports from the same reporter. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: PPV, PPV, PPV
Symptoms: Adverse reaction
Clinical narrative: this spontaneous report as received from a other health professional refers to a 66 year old female patient (Licensed Practical Nurse) with high blood pressure and allergy to penicillin, clindamycin, LEVAQUIN and "sulfa meds". On 02-DEC-2014 the patient was vaccinated with a dose of PNEUMOVAX23 lot # K004542, expiration date:19-AUG-2015, intramuscular, as the doctor recommended. Concomitant therapies included ZYRTEC-D, NAPROSYN, glucosamine, metoprolol, BIOTIN, furosemide manufacturer unknown), lysine, ASMANEX HFA, ZETONNA and fluticasone. On an approximately 04-DEC-2014 (reported as 1.5 days later), the patient experienced arm stiffness and soreness and a red band around her arm an inch below the injection site, the reporter stated that the rash was raised about 1/3 to 1/2 inch and it was 3 inches wide by 6 inches long. The patient called to an unspecified clinic in regards to the reaction and an unspecified healthcare provider, at the clinic, recommended TYLENOL and BENADRYL for treatment, however the nurse stated her did not take anything. No lab diagnostics studies were performed. The nurse stated the rash went away in 4 days (on an approximately 08-DEC-2014) but she was a little stiff and sore. During the conversation the patient also reported that she used to take PLAQUENIL and leflunomide for "my joints" however "neither worked and they raised my blood pressure sky high" (therapies dates and event outcome were not reported). At the time of report, the patient was recovering from arm stiffness and soreness. The patient's outcome of event described as "red band around arm an inch below the injection site" was unknown. This is one of two reports from the same reporter. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: PPV, PPV, PPV
Symptoms: Arthropathy, Blood pressure increased, Condition aggravated, Erythema, Musculoskeletal stiffness
Clinical narrative: this spontaneous report as received from a other health professional refers to a 66 year old female patient (Licensed Practical Nurse) with high blood pressure and allergy to penicillin, clindamycin, LEVAQUIN and "sulfa meds". On 02-DEC-2014 the patient was vaccinated with a dose of PNEUMOVAX23 lot # K004542, expiration date:19-AUG-2015, intramuscular, as the doctor recommended. Concomitant therapies included ZYRTEC-D, NAPROSYN, glucosamine, metoprolol, BIOTIN, furosemide manufacturer unknown), lysine, ASMANEX HFA, ZETONNA and fluticasone. On an approximately 04-DEC-2014 (reported as 1.5 days later), the patient experienced arm stiffness and soreness and a red band around her arm an inch below the injection site, the reporter stated that the rash was raised about 1/3 to 1/2 inch and it was 3 inches wide by 6 inches long. The patient called to an unspecified clinic in regards to the reaction and an unspecified healthcare provider, at the clinic, recommended TYLENOL and BENADRYL for treatment, however the nurse stated her did not take anything. No lab diagnostics studies were performed. The nurse stated the rash went away in 4 days (on an approximately 08-DEC-2014) but she was a little stiff and sore. During the conversation the patient also reported that she used to take PLAQUENIL and leflunomide for "my joints" however "neither worked and they raised my blood pressure sky high" (therapies dates and event outcome were not reported). At the time of report, the patient was recovering from arm stiffness and soreness. The patient's outcome of event described as "red band around arm an inch below the injection site" was unknown. This is one of two reports from the same reporter. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: PPV, PPV, PPV
Symptoms: Pain in extremity, Rash
Clinical narrative: this spontaneous report as received from a other health professional refers to a 66 year old female patient (Licensed Practical Nurse) with high blood pressure and allergy to penicillin, clindamycin, LEVAQUIN and "sulfa meds". On 02-DEC-2014 the patient was vaccinated with a dose of PNEUMOVAX23 lot # K004542, expiration date:19-AUG-2015, intramuscular, as the doctor recommended. Concomitant therapies included ZYRTEC-D, NAPROSYN, glucosamine, metoprolol, BIOTIN, furosemide manufacturer unknown), lysine, ASMANEX HFA, ZETONNA and fluticasone. On an approximately 04-DEC-2014 (reported as 1.5 days later), the patient experienced arm stiffness and soreness and a red band around her arm an inch below the injection site, the reporter stated that the rash was raised about 1/3 to 1/2 inch and it was 3 inches wide by 6 inches long. The patient called to an unspecified clinic in regards to the reaction and an unspecified healthcare provider, at the clinic, recommended TYLENOL and BENADRYL for treatment, however the nurse stated her did not take anything. No lab diagnostics studies were performed. The nurse stated the rash went away in 4 days (on an approximately 08-DEC-2014) but she was a little stiff and sore. During the conversation the patient also reported that she used to take PLAQUENIL and leflunomide for "my joints" however "neither worked and they raised my blood pressure sky high" (therapies dates and event outcome were not reported). At the time of report, the patient was recovering from arm stiffness and soreness. The patient's outcome of event described as "red band around arm an inch below the injection site" was unknown. This is one of two reports from the same reporter. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: PPV, PPV, PPV
Symptoms: Vaccination complication
Clinical narrative: this spontaneous report as received from a other health professional refers to a 66 year old female patient (Licensed Practical Nurse) with high blood pressure and allergy to penicillin, clindamycin, LEVAQUIN and "sulfa meds". On 02-DEC-2014 the patient was vaccinated with a dose of PNEUMOVAX23 lot # K004542, expiration date:19-AUG-2015, intramuscular, as the doctor recommended. Concomitant therapies included ZYRTEC-D, NAPROSYN, glucosamine, metoprolol, BIOTIN, furosemide manufacturer unknown), lysine, ASMANEX HFA, ZETONNA and fluticasone. On an approximately 04-DEC-2014 (reported as 1.5 days later), the patient experienced arm stiffness and soreness and a red band around her arm an inch below the injection site, the reporter stated that the rash was raised about 1/3 to 1/2 inch and it was 3 inches wide by 6 inches long. The patient called to an unspecified clinic in regards to the reaction and an unspecified healthcare provider, at the clinic, recommended TYLENOL and BENADRYL for treatment, however the nurse stated her did not take anything. No lab diagnostics studies were performed. The nurse stated the rash went away in 4 days (on an approximately 08-DEC-2014) but she was a little stiff and sore. During the conversation the patient also reported that she used to take PLAQUENIL and leflunomide for "my joints" however "neither worked and they raised my blood pressure sky high" (therapies dates and event outcome were not reported). At the time of report, the patient was recovering from arm stiffness and soreness. The patient's outcome of event described as "red band around arm an inch below the injection site" was unknown. This is one of two reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Expired product administered, Product label confusion
Clinical narrative: This spontaneous report as received from a pharmacist refers to an unspecified number of patients of unknown age and gender. On an unknown dates those patients were vaccinated with a dose of GARDASIL (lot# reported as: 0629AE, expiry date: 16-DEC-2014, dose, units, route of administration, anatomical location were not reported). The reporter stated that the expiration date on the GARDASIL was really confusing shown as 16-DEC-14. The pharmacist stated that none of the vaccine was administered to any patient, however, 3 of his staff looked at the vial and one verbalized a different response. The reporter stated this lead to product confusion. The pharmacist recommended using a four digit year such as 2014. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 30-DEC-2014, the patient was vaccinated with a expired dose of (Oka/Merck) VARIVAX, (lot number reported as H022155, Expiry date: 18-DEC-2014), 0.5 ml, intramuscular. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from another healthcare professional refers to an unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with an improperly stored dose of GARDASIL (strength, dose, route of administration and lot # were not reported). No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: DTAPHEPBIP
Symptoms: Expired product administered
Clinical narrative: This case was reported by a nurse and described the occurrence of expired vaccine used in a patient who received PEDIARIX. On an unknown date, the patient received PEDIARIX at an unknown dose. On an unknown date, an unknown time after receiving PEDIARIX, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown. Additional information received: Expired dose possibly given, not confirmed.
Age: 21.0
Sex: M
Vaccine: HPV4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from nurse refers to a 21-year-old male patient. Information about concurrent conditions and medical history was not provided. On an unknown date a client was inadvertently administered a fourth dose of GARDASIL (route, strength, dose, lot, batch # and expiration date not reported). Co-suspect and concomitant therapies were not reported. No adverse effects reported. Additional information is not expected because it is not possible to contact the physician.
Age: 0.18
Sex: F
Vaccine: HEP, RV5, TDAP
Symptoms: Wrong drug administered
Clinical narrative: Was given a Tdap instead of a DTaP-IPV-HIB.
Age: 1.14
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 1 year old patient of unknown gender. On 23-DEC-2014 the patient was vaccinated with the first dose of PROQUAD (Merck) which was improperly stored, lot# K007801 with expiration date of 29-NOV-2015, 0.5 ml once, subcutaneous. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to 3 patients of unknown age and gender. Concomitant medication and current conditions were not reported. On 08-DEC-2014, the patients were vaccinated with an improperly stored dose of PEDVAXHIB (dose, route, lot number and expiration date were not reported). Concomitant medications were not provided. No adverse effects reported. This is one of several reports 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 as received from a Licensed Practical Nurse refers to an unspecified number of patients of unknown age and gender. Concomitant medication and current conditions were not reported. On an unknown date, the patients were vaccinated with an improperly stored dose of VARIVAX (Merck) (lot number reported as K008820 and expiration date 19-JUN-2016, route and dose were not reported). Concomitant medication was not provided. No adverse effects reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to 2 unspecified patients of unknown age and gender. Concomitant medication and current conditions were not reported. On 02-DEC-2014, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 (dose, route, lot number and expiration date were not reported). Concomitant medications were not provided. No adverse effects reported for any patient. This is one of several reports from the same reporter. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Hyperaesthesia, Induration, Pain, Pyrexia
Clinical narrative: Red, indurated, warm and not directly around injection site. Was sensitive, fever, painful.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Skin warm
Clinical narrative: Red, indurated, warm and not directly around injection site. Was sensitive, fever, painful.
Age: 29.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Cellulitis, Injection site erythema, Injection site pain
Clinical narrative: Patient had redness and soreness at the site of injection. Patient states she went to an urgent care center where they say she had cellulitis.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of unspecified patients of unknown age. On an unspecified dates, doses of improperly stored (Oka/Merck) VARIVAX (dose/frequency and lot# were unknown) might had been administered to patients for prophylaxis; this was unable to be confirmed with nurse. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 0.3
Sex: U
Vaccine: HBHEPB, HIBV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 4 month old patient of unknown gender. On 02-JAN-2015 the patient was inadvertently administered with a dose of LIQUID PEDVAXHIB (0.5 ml, intramuscular) and a dose of COMVAX. No adverse effects was reported. Additional  information has been requested.
Age: 0.58
Sex: F
Vaccine: FLU3
Symptoms: Decreased appetite, Hypersomnia, Irritability, Pyrexia
Clinical narrative: Fussy, low grade temp, slept a lot, symptoms x 2 day, decreased appetite, woke up on day 3 and was fine.
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from the patient's mother concerning to her daughter a 12 month old female patient. Concurrent conditions, medical history and allergies were not reported. On 12-DEC-2014, the patient was vaccinated with a dose of M-M-R II, (strength, dose, frequency, route, anatomical location, lot number and expiration date were not reported). Other suspect and concomitant therapies were not reported. The reporter stated that she got a call from the Doctor's office stating that her daughter was vaccinated with improperly stored M-M-R II. The reporter stated that the office wanted to revaccinate her daughter, because the vaccine was not effective. The reporter wanted to know if that was necessary. No adverse effects reported. Additional information is not expected. The reporter did not consent to contact the physician.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of unspecified patients of unknown age. On an unspecified dates, doses of improperly stored PROQUAD (Merck) (dose/frequency and lot # were unknown) might had been administered to the patients; this was unable to be confirmed with nurse. No adverse effect reported. This is one of several reports received from same source. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 4 year old patient of unknown gender. On 22-DEC-2014 the patient was vaccinated with the second dose of PROQUAD (Merck) which was improperly stored, lot# K007801 with expiration date 29-NOV-2015, 0.5 ml once, subcutaneous. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster, Neuralgia, Paraesthesia, Rash, X-ray limb normal
Clinical narrative: This spontaneous report as received from a Nurse refers to a 17 year old female patient with drug allergy to amoxicillin that causes a rash like hives. On 22-JUL-1998, the patient was vaccinated with a dose of VARIVAX (Merck) (dose and route were not reported) lot number reported as: 0650H, expiration date: 21-OCT-1999 (route not reported). Patient was vaccinated a second time on 01-APR-2008 with a dose of VARIVAX (Merck) (dose and route were not reported) lot number reported as: 1593U, expiration date: 28-SEP-2009 (route not reported). Concomitant therapies included DESOGEN and naproxen. On 25-SEP-2014, the patient experienced paresthesia of the thumb and wrist, which spread to right side of neck. On 26-SEP-2014 the patient experienced rash on right side of neck and down the right arm. Patient was seen by an unspecified physician on an unknown date. Patient was also seen in an emergency room at the clinic on 27-OCT-2014 for shingles. On 05-DEC-2014, the patient was diagnosed with neuralgia right extremity, no lesions and a benign exam. The onset date of the events was reported as 25-SEP-2014. Patient was seen by Neurologist on 07-NOV-2014. Was also seen by infectious disease physician on 05-DEC-2014. Patient was treated with FAMVIR and NEUROTIN. The outcome of the events was reported as recovering. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of unspecified patients of unkonwn age. On an unspecified dates, the patients were received PNEUMOVAX 23 (dose/frequency and lot # were unknown), which had been stored improperly. No adverse effect reported. This is one of several reports received from same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to an adult patient of unknown age and gender. On 31-DEC-2014 the patient was vaccinated with two pediatric doses of RECOMBIVAX HB (each dose 0.5 ml, total dose: 1 ml, route: intramuscular) (lot# unknown) which was improperly stored (exposed to centigrade degree for 24 hours). No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 19-DEC-2014 the patient was vaccinated with a dose of M-M-R II which was expired on 18-OCT-2014 (dose and lot# were unknown) subcutaneous. No adverse effects were reported. This is one of two reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Sinusitis
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 24-DEC-2014, the patient was vaccinated with ZOSTAVAX (dose, lot number, expiration date were not provided). On an unknown date, the patient experienced sinusitis. The patient was prescribed dexamethasone nasal spray. At the time of the report the patient did not recover from the event. Relatedness between sinusitis and ZOSTAVAX was not reported. Additional information is not expected as the pharmacist does not want to be contacted regarding the report.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health care worker refers to a patient of unknown age and unknown gender. The patient's pertinent medical history was not reported. On 07-NOV-2014 the patient was vaccinated with VARIVAX (Merck) (dose, frequency and route were not reported) that underwent a supported temperature excursion. No adverse experiences reported. No product quality complaint (PQC) was reported for VARIVAX (Merck). This case is linked to case # 1501USA001936 (same reporter link). Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health care worker refers to a patient of unknown age and unknown gender. The patient's pertinent medical history was not reported. On 17-NOV-2014 the patient was vaccinated with VARIVAX (Merck) (dose, frequency and route were not reported) that underwent a supported temperature excursion. No adverse experiences reported. No product quality complaint (PQC) was reported for VARIVAX (Merck). This case is linked to case # 1501USA001374 (same reporter link). Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood pressure decreased, Condition aggravated, Dizziness, Fatigue, Hypersomnia
Clinical narrative: This spontaneous report refers to a 65-year-old female patient reporting on herself. Pertinent medical history included high blood pressure and reaction/allergy to KEFLEX. On 19-DEC-2014 the patient was vaccinated with ZOSTAVAX (strength, route, dose, lot, batch # and expiration date not reported) in the left arm. Concomitant therapies included medication for blood pressure. On 21-DEC-2014 she was extremely tired and slept for almost the whole day. On 22-DEC-2014, she felt faint and had a drop in blood pressure. She also reported that the vaccination site was hot to touch and she had a rash. (On an unknown date in December 20140. She saw a non-primary doctor who marked the rash with a marker to see if it spread. There was not treatment given for the events. The outcome of vaccination site was hot to touch and she had a rash was not recovered. The outcome of she felt faint, she was extremely tired, she slept for almost the whole day and had a drop in blood pressure was unknown. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypertension, Injection site rash, Injection site warmth
Clinical narrative: This spontaneous report refers to a 65-year-old female patient reporting on herself. Pertinent medical history included high blood pressure and reaction/allergy to KEFLEX. On 19-DEC-2014 the patient was vaccinated with ZOSTAVAX (strength, route, dose, lot, batch # and expiration date not reported) in the left arm. Concomitant therapies included medication for blood pressure. On 21-DEC-2014 she was extremely tired and slept for almost the whole day. On 22-DEC-2014, she felt faint and had a drop in blood pressure. She also reported that the vaccination site was hot to touch and she had a rash. (On an unknown date in December 20140. She saw a non-primary doctor who marked the rash with a marker to see if it spread. There was not treatment given for the events. The outcome of vaccination site was hot to touch and she had a rash was not recovered. The outcome of she felt faint, she was extremely tired, she slept for almost the whole day and had a drop in blood pressure was unknown. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On an unspecified date the patient received an incorrect 0.5ml dose of ZOSTAVAX (route and lot# unknown) due to a product quality complaint (PQC). No adverse reactions were reported. Additional information has been requested.
Age: 7.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: Left deltoid red and swollen. TYLENOL/MOTRIN 3-4 x a day as needed.
Age: 44.0
Sex: M
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 44 year old male patient. On 08-DEC-2014 the patient was inadvertently vaccinated with a dose of ZOSTAVAX (dose, units, route of administration, anatomical location, lot number were not reported) indicated for their first dose of VARIVAX (Merck). No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 16-DEC-2014 the patient was vaccinated intramuscularly with an expired dose of RECOMBIVAX HB (therapy type was not reported, 1 ml, lot # J014312, expiration date 07-SEP-2014). No adverse effect was reported. No PQC (product quality complaint) was involved. Additional information has been requested.
Age: 1.01
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Cough, Diarrhoea, Ear infection, Influenza, Influenza virus test positive
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a 12 month old male patient with amoxicillin allergy and no pertinent medical history. On 18-DEC-2014 the patient was vaccinated with the first dose of VARIVAX (Merck) (route, dose and frequency unknown) and the first dose of M-M-R II (route, dose and frequency unkown). Concomitant therapies included ZYRTEC and albuterol. On 20-DEC-2014, 3 days after onset of therapy the patient experienced the Flu and ear infection. The patient first developed a low grade fever, which progressed to cough and a runny nose prior to "testing positive" for the Flu. The patient developed vomiting and diarrhea after taking amoxicillin (manufacturer of amoxicillin unknown). TAMIFLU, TYLENOL, ibuprofen and OMNICEF were given to treat the adverse event. The patient sought medical attention via office visit. The outcome of adverse events was reported as recovered/resolved. Additional information has been requested.
Age: 1.01
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Pyrexia, Rhinorrhoea, Vomiting
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a 12 month old male patient with amoxicillin allergy and no pertinent medical history. On 18-DEC-2014 the patient was vaccinated with the first dose of VARIVAX (Merck) (route, dose and frequency unknown) and the first dose of M-M-R II (route, dose and frequency unkown). Concomitant therapies included ZYRTEC and albuterol. On 20-DEC-2014, 3 days after onset of therapy the patient experienced the Flu and ear infection. The patient first developed a low grade fever, which progressed to cough and a runny nose prior to "testing positive" for the Flu. The patient developed vomiting and diarrhea after taking amoxicillin (manufacturer of amoxicillin unknown). TAMIFLU, TYLENOL, ibuprofen and OMNICEF were given to treat the adverse event. The patient sought medical attention via office visit. The outcome of adverse events was reported as recovered/resolved. Additional information has been requested.
Age: 1.56
Sex: M
Vaccine: HIBV, MMR, VARCEL
Symptoms: Urticaria
Clinical narrative: Mild hives on abdomen within an hour after MMR, varicella and HIB. BENADRYL 6.25 ml/2.5 ml given PO and good result.
Age: 1.03
Sex: F
Vaccine: HEPA, MMRV
Symptoms: Convulsion
Clinical narrative: Baby had a convulsion 5 days after receiving MMR/V and Hepatitis A vaccines. No fever at home. Lasted 3 minutes.
Age: 66.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Injection site pain
Clinical narrative: This spontaneous report was received from a 66 year old male patient with VICODIN allergy and codeine allergy who was reporting on himself. There was no patient's medical history. On 06-OCT-2014 the patient was vaccinated by a pharmacist with a dose of PNEUMOVAX 23 (injection, in the left arm, lot number: K009107, expiry date: 21-JAN-2016, dose number and route of administration were not reported). Concomitant therapies included influenza virus vaccine (unspecified) (reported as Flu shot) (manufacturer and dose unknown) (given on the same day but administered in the right arm), SPIRIVA and morphine sulfate (manufacturer and dose unknown). On 06-OCT-2014, after receiving the PNEUMOVAX 23, the patient experienced injection site pain. No treatment was given for adverse event and no lab diagnostic was performed. The patient did not seek medical attention. The outcome of the event was reported as not recovered. The relatedness between PNEUMOVAX 23 and the event was not reported. Per instructions from the pharmacist, the patient was requesting a lot check for PNEUMOVAX 23. Additional information has been requested.
Sex: U
Vaccine: HEP, HEPA, TDAP
Symptoms: Incorrect product storage
Clinical narrative: This case was reported by a nurse and described the occurrence of incorrect storage of drug in a patient who received BOOSTRIX (batch number N4L77, expiry date 27th March 2016). Co-suspect products included HAVRIX (batch number K4H7M, expiry date 11th February 2016), HAVRIX (batch number 5324E, expiry date 30th October 2016), HAVRIX (batch number YZ27F, expiry date 18th March 2016), ENGERIX B (batch number AHBVC188BA, expiry date 18th January 2015) and ENGERIX B (batch number 772GY, expiry date 23rd November 2015). On an unknown date, the patient received BOOSTRIX, HAVRIX, HAVRIX, HAVRIX, ENGERIX B and ENGERIX B. On an unknown date, an unknown time after receiving BOOSTRIX, HAVRIX, HAVRIX, HAVRIX, ENGERIX B and ENGERIX B, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown. Additional information received: HCP wants to know the stability of BOOSTRIX, HAVRIX and ENGERIX-B after being exposed to temps, out of the normal range at different times from January up until today. They recently had an inspection by the state and were made aware of the importance of maintaining the vaccine at the appropriate temp. All three vaccines were exposed to a low temp of 30F and only HAVRIX was exposed to a warm temp. of 48F. Multiple pts. have received doses of these vaccines after they were not stored properly. HCP hasn't gone through each pts. chart yet. She did not have pt. initials, DOB's, M/F data ready to provide, but said we can follow-up with her through mail/email. She did provide lot # and exp. date. For HAVRIX: lot# K4H7M Exp. 2/11/16, lot # YZ27F exp. 3/18/16 and lot # 5324E exp. 10/30/16. For ENGERIX-B: lot# AHBVC188BA exp. 1/18/15 and 772GY exp. 11/23/15. For BOOSTRIX: lot# N4L77 exp. 3/27/16.
Sex: F
Vaccine: HEP
Symptoms: Extra dose administered
Clinical narrative: This case was reported by a other health professional and described the occurrence of extra dose administered in a female patient who received ENGERIX B (batch number F2LR7, expiry date 9th October 2016). In October 2014, the patient received ENGERIX B. On an unknown date, an unknown time after receiving ENGERIX B, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown. Additional information received: HCP at dental office given one dose of ENGERIX-B two weeks ago as she did not have documentation that she had previously been vaccinated. She then brought documentation of the series completion 10yrs ago. No patient details immediately available.
Age: 15.0
Sex: U
Vaccine: HEP
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse refers to a 15 year old patient. On 17-APR-1999, 10-MAY-1999 and 04-NOV-2000, the patient was vaccinated with the first, second and third pediatric dose of RECOMBIVAX HB respectively. The nurse stated that the second dose was only 23 days. No adverse effects reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Nasopharyngitis, Productive cough
Clinical narrative: This spontaneous report as received from a female patient of unknown age refers to herself. On 02-JAN-2015 the patient was vaccinated with ZOSTAVAX 1 single shot (dose, route and lot# unknown). The patient reported, in approximately January 2015, "after received ZOSTAVAX, she developed a bad cold and she have coughed up a thick substance'. The patient had sought medical attention by spoke with pharmacist. The outcome of the events was reported as not recovered/not resolved. No PQC (Product Quality Control) involved. Additional information is not expected since no reporter contact information.
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. On 05-JAN-2015 the patient was inadvertently vaccinated with an expired dose of ZOSTAVAX (lot # J011550, expiration date 19-DEC-2014, dose and frequency were unknown). No adverse effect was reported. Additional information has been requested.
Age: 1.01
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 1 year old patient of unknown gender. On 30-DEC-2014 the patient was vaccinated with the first dose of PROQUAD (Merck), which was improperly stored, lot# K007801 with expiration date of 29-NOV-2015, 0.5 ml once, subcutaneous. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age. Reporter reported that an unspecified number of unspecified patients received improperly stored doses of oral ROTATEQ (lot# was not reported) on unspecified dates. No adverse effect reported. This is one of the reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age. Reporter that an unspecified number of unspecified patients received improperly stored doses of RECOMBIVAX HB (lot# was not reported) on unspecified dates. No adverse effect reported. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV2
Symptoms: Fluid retention, Inappropriate schedule of drug administration, Injected limb mobility decreased, Injection site pain, Injection site reaction
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of arm pain at injection site in a 15-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). Historic vaccination included CERVARIX; GlaxoSmithKline; unknown given on 30 Jun 2013. On 23 June 2014, the subject received 2nd dose of CERVARIX (route unknown, left arm) 1 year after 1st dose which lead to an incorrect schedule. On 23 June 2014, 2 days after vaccination with CERVARIX, the subject experienced arm pain at injection site, injection site movement impairment and fluid collection at injection site which was not cellulitis. At the time of reporting, the events were unresolved.
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Drug administered at inappropriate site, Injected limb mobility decreased, Pain, X-ray limb
Clinical narrative: Limited mobility of left arm. Excruciating pain.  Ibuprofen taken daily for pain.  Injection sight was not accurate.  Shot given too high on arm, near bone.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Adverse drug reaction, Back pain, Computerised tomogram normal, Convulsion, Electroencephalogram normal
Clinical narrative: This spontaneous report was received from a 65 year old male patient (a pharmacist) with no drug reactions or allergies and refers to himself. The patient's medical history included craniotomy when the patient was 7 year old (in 1956). On 27-DEC-2014 the patient was vaccinated with ZOSTAVAX (route, dose, frequency and lot # not reported). Concomitant therapies included cholecalciferol, vitamin B complex and multivitamins (unspecified). On 30-DEC-2014 the patient had seizure after receiving ZOSTAVAX. The patient stated he went to the emergency room where he was treated with intravenous (IV) fluids (unspecified) and KEPPRA. On 30-DEC-2014 the patient underwent blood work at the emergency room which showed that he had a low protein level (units not provided). The electroencephalogram (EEG) and computerized tomography (CT) scan that were performed in the emergency room were normal (on 30-DEC-2014). The patient stated he was not admitted to hospital. The patient was sent home with oral KEPPRA and discontinued taking the medication because he was feeling weird (date unspecified). The patient continued to experience upper back and muscle pain after having the seizure (date unspecified). The patient was seen by an unspecified neurologist and was scheduled for a magnetic resonance imaging (MRI) and electroencephalogram (EEG) on an unspecified date. The patient's present status was reported as recovering. The patient sought medical attention and was seen in an emergency room (ER). The relatedness between the events and ZOSTAVAX was not reported. Upon internal review seizure was determined to be medically significant. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Feeling abnormal, Myalgia, Protein total decreased
Clinical narrative: This spontaneous report was received from a 65 year old male patient (a pharmacist) with no drug reactions or allergies and refers to himself. The patient's medical history included craniotomy when the patient was 7 year old (in 1956). On 27-DEC-2014 the patient was vaccinated with ZOSTAVAX (route, dose, frequency and lot # not reported). Concomitant therapies included cholecalciferol, vitamin B complex and multivitamins (unspecified). On 30-DEC-2014 the patient had seizure after receiving ZOSTAVAX. The patient stated he went to the emergency room where he was treated with intravenous (IV) fluids (unspecified) and KEPPRA. On 30-DEC-2014 the patient underwent blood work at the emergency room which showed that he had a low protein level (units not provided). The electroencephalogram (EEG) and computerized tomography (CT) scan that were performed in the emergency room were normal (on 30-DEC-2014). The patient stated he was not admitted to hospital. The patient was sent home with oral KEPPRA and discontinued taking the medication because he was feeling weird (date unspecified). The patient continued to experience upper back and muscle pain after having the seizure (date unspecified). The patient was seen by an unspecified neurologist and was scheduled for a magnetic resonance imaging (MRI) and electroencephalogram (EEG) on an unspecified date. The patient's present status was reported as recovering. The patient sought medical attention and was seen in an emergency room (ER). The relatedness between the events and ZOSTAVAX was not reported. Upon internal review seizure was determined to be medically significant. Additional information has been requested.
Age: 21.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Adrenal medulla hyperfunction, Anxiety, Blindness, Chest pain, Hypertension
Clinical narrative: Experienced random tachycardia/palpitations/high blood pressure/vision loss/increased adrenal production/anxiety/chest pain. -August 2013. Since onset, have been diagnosed with Inappropriate sinus Tachycardia/ Melloadrenal Hyperfunction/ Uhthoff's syndrome.
Age: 21.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Palpitations, Sinus tachycardia, Tachycardia, Uhthoff's phenomenon
Clinical narrative: Experienced random tachycardia/palpitations/high blood pressure/vision loss/increased adrenal production/anxiety/chest pain. -August 2013. Since onset, have been diagnosed with Inappropriate sinus Tachycardia/ Melloadrenal Hyperfunction/ Uhthoff's syndrome.
Age: 88.0
Sex: M
Vaccine: FLU3, PNC13, FLU3, PNC13
Symptoms: Balance disorder, Fall, Gait disturbance, Guillain-Barre syndrome, Lumbar puncture abnormal
Clinical narrative: Received vaccines (2) on Oct. 2, 2014, no symptoms until Thanksgiving Day Nov. 27th (patient was wobbly). Friday patient fell, brought to MD (Dr. on Monday) took MRI with normal results, following Tuesday patient fell again taken to ED (no strength in arms/hands/feet). Admitted for 5 days incontinent, now in nursing home for rehab fell numerous times since vaccine. Slow rehab currently - can sit/ambulate slowly, very tired, diagnosed with Guillain-Barre Syndrome.