chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. On an unknown dates the patients in her facility received doses of ROTATEQ (strength, dose, route and lot number were not provided), that may have been exposed to 9C for approximately 8 days. Concomitant medications were not provided. At the time of the report medical assistant did not have access to the vaccination records, or the lot numbers of the doses that were administered. This case is linked to cases 1309USA005768 and 1311USA012345 via same reporter link. Additional information has been requested.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site pain, Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: This spontaneous report as received from a consumer refers to a 59 year old female patient. The patient's medical history included caesarean section and ruptured appendix. The patient had a drug allergy to Betadine, where she lost a layer of skin and her skin was peeling. On 06-NOV-2013 the patient was vaccinated with ZOSTAVAX 1 shot. No concomitant medications were taken. On 07-NOV-2013, 2 days after onset of therapy the patient experienced injection site reaction. The reaction was a rash, hot to touch, raised, painful, wit no blisters, swollen, bruised, itchy and was 3 inches in size. No laboratory tests were done. The patient sought medical attention by contacting the physician. The patient took one Benadryl tablet as treatment. Patient was not hospitalized for the event. No product quality complaint was involved. The outcome of injection site reaction was reported as not recovered/not resolved. Causality assessment was not provided. Additional information is not expected.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth
Clinical narrative: This spontaneous report as received from a consumer refers to a 59 year old female patient. The patient's medical history included caesarean section and ruptured appendix. The patient had a drug allergy to Betadine, where she lost a layer of skin and her skin was peeling. On 06-NOV-2013 the patient was vaccinated with ZOSTAVAX 1 shot. No concomitant medications were taken. On 07-NOV-2013, 2 days after onset of therapy the patient experienced injection site reaction. The reaction was a rash, hot to touch, raised, painful, wit no blisters, swollen, bruised, itchy and was 3 inches in size. No laboratory tests were done. The patient sought medical attention by contacting the physician. The patient took one Benadryl tablet as treatment. Patient was not hospitalized for the event. No product quality complaint was involved. The outcome of injection site reaction was reported as not recovered/not resolved. Causality assessment was not provided. Additional information is not expected.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. On an unknown date the patients in her facility received doses of RECOMBIVAX HB (strength, dose, route and lot number were not provided) that may have been exposed to 9C for approximately 8 days. Concomitant medications were not provided. At the time of the report medical assistant did not have access to the vaccination records, or the lot numbers of the doses there were administered. This case is linked to cases1311USA012344 and 1309USA005768 via sane reporter link. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report was received from a female patient of unknown age referring to herself. On 12-NOV-2013, the patient was vaccinated with ZOSTAVAX vial, dose: standard/single dose, route: injection (lot number was not reported). No concomitant medications were reported. On 13-NOV-2013, one day after receiving ZOSTAVAX, the patient experienced injection-site redness, lump, soreness, swelling and warmth. The patient did not seek medical attention. The outcome of the events was reported as not recovered. Additional information is not expected.
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Neuralgia, Pain, Pain of skin, Rash erythematous
Clinical narrative: This spontaneous report as received from a female consumer reporting on herself who last December in approximately December 2012, was vaccinated with a dose of ZOSTAVAX (dose, route and lot number not reported). The consumer reported that now in approximately November 2013, she had broken out with a terrible pain across the belly accompanied by little red bumps. The consumer stated that her physician felt that she had developed neuralgia only, and had not had a full outbreak of shingles due to the lack of itchy legions usually indicative of the condition. The consumer confirmed that the area did not itch, but felt as though she had pain in and under the skin in that area. The consumer also mentioned that she had had shingles in the same area years before having the vaccine. Gabapentin 10mg had been unsuccessful and OTC biofreeze treats temporarily. At the time of the report, he patient's outcome was unknown. The relatedness for pain across the belly accompanied by little red bumps and neuralgia and ZOSTAVAX was unknown. Additional information is not expected.
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. Pertinent medical history and drug reactions/allergies were not reported. On 21-NOV-2012, the patient was vaccinated with a first dose of GARDASIL 0.5 ml, intramuscular and on 21-NOV-2013, the patient was vaccinated with a second dose of GARDASIL. Concomitant therapy was not reported. No adverse effects reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient "in their 50's" years of age. About 2 weekends ago, approximately on 09-NOV-2013 the patient was vaccinated with one dose of ZOSTAVAX. It was reported that the patient received ZOSTAVAX and then developed an injection site reaction which consisted of redness and swelling in November 2013. The outcome of the events was reported as recovering/resolving. The patient sought medical attention by speaking to the pharmacist by phone. Additional information has been requested.
Age: 83.0
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 83 year old patient (first of 2 patients). On 20-NOV-2013 the patient was vaccinated with ZOSTAVAX vial of lot # J001729 and expiry date 20-OCT-2013, dose 0.65 ml, via subcutaneous route. The patient had received an expired dose of ZOSTAVAX. No adverse effect was reported. This is 1 of 2 reports received from same reporter. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Pain, Rash
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative refers to a 66 year old female patient. ON 03-NOV-2013 the patient was vaccinated with ZOSTAVAX. The dose number, lot number, expiry date, route of administration and anatomical location were not reported. Within four days following the administration, the patient developed a dime-sized rash on her face, described as painful and blistering. An appointment with a physician was made for medical attention. Treatment information was not reported. The outcome of dime-sized rash on her face is unknown. Additional information has been requested.
Age: 44.0
Sex: F
Vaccine: HPV4
Symptoms: Vomiting
Clinical narrative: This spontaneous report as received from a 44 year old female patient regarding herself via a market research agency. On an unknown date in 2012 the patient was vaccinated with GARDASIL (lot number and frequency unknown) dose 3 (dosing regimen and frequency unknown). On an unknown date in 2012 the patient threw up after last shot. It was reported that the event diminished after stopping suspect therapy. The outcome of threw up after last shot was unknown. The reporter considered the events to be related to the therapy with GARDASIL. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a Medical assistant concerning to an unspecified number of patients. On an unknown date the patients were vaccinated with a dose of VARIVAX (Merck) (dose, route, lot # and expiration date not provided). No other co-suspect therapy was reported. Concomitant medications were not provided. It was reported that an improperly stored VARIVAX (Merck) was administered to an unspecified amount of patients. The VARIVAX (Merck) had had multiple excursions since June 2013 reaching a highest temperature of -100C for a total time of 864 hours. The reported did not think that the overall average temperature for the VARIVAX (Merck) had remained between -50C and -15C. She reported that the VARIVAX (Merck) was also exposed to 08C for 24 hours on an unspecified date. No adverse effect reported. At the time of the report patients outcome was unknown. Additional information has been requested.
Age: 2.0
Sex: F
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a 2 years and 5 months old female patient. On 19-NOV-2013 the patient was vaccinated with the first dose of MMR II (lot # 1579AA, expiry date 12-OCT-2013, 0.5 ml, intramuscular) and it was expired. No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to unspecified number of patients. Nurse reported that improperly stored PROQUAD (Merck) (dose, route, lot # and expiration date not provided) was administered to some patients. Nurse believed that a total of 32 patiens received either improperly stored VARIVAX (Merck) or improperly stored PROQUAD (Merck). The PROQUAD (Merck) was exposed to the same conditions as the VARIVAX (Merck) both vaccines were stored in the same freezer. A medical assistant reported that the VARIVAX (Merck) had multiple excursions since June 2013 reaching a highest temperature of -10C for a total time of 864 hours. The reportee did not think that the overall average temperature for the VARIVAX (Merck) had remained between -50C and -15C. She reported that the VARIVAX (Merck) was also exposed to 8C for 24 hours on an unspecified date. MARRS#1311USA002616. No symptoms reported. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Bursitis, Immediate post-injection reaction, Injected limb mobility decreased, X-ray normal
Clinical narrative: When shot was given hurt real bad and continued to get worse, unable to move left arm and not able to sleep. Reported it and went to family doc. Took Xray of arm and gave me pain medicine which didn't help much. Lot of anxiety - X-rays were normal but the pain was intense still. It is starting to fill a little better but hurts where shot given.
Age: 63.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Anxiety, Injected limb mobility decreased, Injection site pain, Insomnia, X-ray normal
Clinical narrative: When shot was given hurt real bad and continued to get worse, unable to move left arm and not able to sleep. Reported it and went to family doc. Took Xray of arm and gave me pain medicine which didn't help much. Lot of anxiety - X-rays were normal but the pain was intense still. It is starting to fill a little better but hurts where shot given.
Age: 24.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This spontaneous prospective pregnancy report was received from a registered nurse refers to an approximately 24 year old female patient. The patient's medical history included incompetent cervix. The patient has a history of 2 previous pregnancies and 2 pre-term deliveries (at 33 and 35 weeks from LMP). No birth defects were reported in previous pregnancies. One infant(first child) had a pre-mature birth and was in the NICU for 1 month. The first child has asthma. On 20-NOV-2013, the patient was vaccinated with GARDASIL (lot # H009746, expiry: unknown) dose 1. The patient became pregnant with LMP of 01-NOV-2013 and EDD of 08-AUG-2014. The estimated date of conception was reported as 15-NOV-2013. Initial exposure to GARDASIL was at 2 week(s). The pregnancy outcome was pending. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Exposure during pregnancy
Clinical narrative: This spontaneous prospective pregnancy report was received from a registered nurse refers to an approximately 24 year old female patient. The patient's medical history included incompetent cervix. The patient has a history of 2 previous pregnancies and 2 pre-term deliveries (at 33 and 35 weeks from LMP). No birth defects were reported in previous pregnancies. One infant(first child) had a pre-mature birth and was in the NICU for 1 month. The first child has asthma. On 20-NOV-2013, the patient was vaccinated with GARDASIL (lot # H009746, expiry: unknown) dose 1. The patient became pregnant with LMP of 01-NOV-2013 and EDD of 08-AUG-2014. The estimated date of conception was reported as 15-NOV-2013. Initial exposure to GARDASIL was at 2 week(s). The pregnancy outcome was pending. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: FLUN4, MNQ, TDAP
Symptoms: Abdominal pain lower, Activities of daily living impaired, Appendicitis, Blood test normal, Dizziness
Clinical narrative: Nov. 12th (the 4th day after receiving the flu vaccine): o Strong headache, dizziness, vomiting, ear ache o The dizziness, vomiting, and ear ached lasted for a couple of days, and a headache continued. o He saw a doctor twice that week.  Gave Tylenol that week.  Nov. 18th  o Stronger headache returned, along with vomiting, fever 101.5.  The fever was for about 3 days. o Ibuprofen (didn't help)  Nov. 21st o One doctor thought she found symptoms of "hand, foot, mouth" disease, but this diagnoses changed quickly. o Headache continues  Nov. 24th o Persistent abdominal pain, lower right side o Didn't seem to have other symptoms of appendicitis, and that pain diminished the next day. o Headache continues o Prescribed naproxen (didn't help) o Ordered MRI  done Nov 25th  result "normal"  Nov 26th o Headache continues o Gave "Migranal" nasal spray for migraine  made the headache worse o Gave 15 mg Toradol (IV) & 500 mg Depacon  headache intensity lessoned somewhat, from a "7" to "4.5", but didn't get rid of it. o Prescribed further migraine medicine  Migrelief, Omega 3 fatty acids, vitamin D 2000, more Migranal, and Maxalt.  (We didn't try the Maxalt since it's supposed to be given at the start of a migraine, and due to the conflict with Migranal.)  Nov. 27th o Headache continues o Evaluated at OHSU ER.  Discussed option of doing spinal tap, but didn't do that test yet.  There was not a strong push for it, given the absence of other symptoms. o Gave Vicodin and nausea medicine Zofran.  Helped somewhat, but headache still continues. o Referred to Kaiser neurologist after the Thanksgiving holiday  Nov. 28th o Still using Vicodin.  Seems to help some, but the headache continues, level 5 or 6 on his scale of 1-10.  He has missed about 10 days of school.  The headache continues.  Each doctor has given the basic "neurological exam"  all have been normal.
Age: 11.0
Sex: M
Vaccine: FLUN4, MNQ, TDAP
Symptoms: Ear pain, Headache, Neurological examination normal, Nuclear magnetic resonance imaging normal, Pyrexia
Clinical narrative: Nov. 12th (the 4th day after receiving the flu vaccine): o Strong headache, dizziness, vomiting, ear ache o The dizziness, vomiting, and ear ached lasted for a couple of days, and a headache continued. o He saw a doctor twice that week.  Gave Tylenol that week.  Nov. 18th  o Stronger headache returned, along with vomiting, fever 101.5.  The fever was for about 3 days. o Ibuprofen (didn't help)  Nov. 21st o One doctor thought she found symptoms of "hand, foot, mouth" disease, but this diagnoses changed quickly. o Headache continues  Nov. 24th o Persistent abdominal pain, lower right side o Didn't seem to have other symptoms of appendicitis, and that pain diminished the next day. o Headache continues o Prescribed naproxen (didn't help) o Ordered MRI  done Nov 25th  result "normal"  Nov 26th o Headache continues o Gave "Migranal" nasal spray for migraine  made the headache worse o Gave 15 mg Toradol (IV) & 500 mg Depacon  headache intensity lessoned somewhat, from a "7" to "4.5", but didn't get rid of it. o Prescribed further migraine medicine  Migrelief, Omega 3 fatty acids, vitamin D 2000, more Migranal, and Maxalt.  (We didn't try the Maxalt since it's supposed to be given at the start of a migraine, and due to the conflict with Migranal.)  Nov. 27th o Headache continues o Evaluated at OHSU ER.  Discussed option of doing spinal tap, but didn't do that test yet.  There was not a strong push for it, given the absence of other symptoms. o Gave Vicodin and nausea medicine Zofran.  Helped somewhat, but headache still continues. o Referred to Kaiser neurologist after the Thanksgiving holiday  Nov. 28th o Still using Vicodin.  Seems to help some, but the headache continues, level 5 or 6 on his scale of 1-10.  He has missed about 10 days of school.  The headache continues.  Each doctor has given the basic "neurological exam"  all have been normal.
Age: 11.0
Sex: M
Vaccine: FLUN4, MNQ, TDAP
Symptoms: Streptococcus test negative, Urine analysis normal, Vomiting
Clinical narrative: Nov. 12th (the 4th day after receiving the flu vaccine): o Strong headache, dizziness, vomiting, ear ache o The dizziness, vomiting, and ear ached lasted for a couple of days, and a headache continued. o He saw a doctor twice that week.  Gave Tylenol that week.  Nov. 18th  o Stronger headache returned, along with vomiting, fever 101.5.  The fever was for about 3 days. o Ibuprofen (didn't help)  Nov. 21st o One doctor thought she found symptoms of "hand, foot, mouth" disease, but this diagnoses changed quickly. o Headache continues  Nov. 24th o Persistent abdominal pain, lower right side o Didn't seem to have other symptoms of appendicitis, and that pain diminished the next day. o Headache continues o Prescribed naproxen (didn't help) o Ordered MRI  done Nov 25th  result "normal"  Nov 26th o Headache continues o Gave "Migranal" nasal spray for migraine  made the headache worse o Gave 15 mg Toradol (IV) & 500 mg Depacon  headache intensity lessoned somewhat, from a "7" to "4.5", but didn't get rid of it. o Prescribed further migraine medicine  Migrelief, Omega 3 fatty acids, vitamin D 2000, more Migranal, and Maxalt.  (We didn't try the Maxalt since it's supposed to be given at the start of a migraine, and due to the conflict with Migranal.)  Nov. 27th o Headache continues o Evaluated at OHSU ER.  Discussed option of doing spinal tap, but didn't do that test yet.  There was not a strong push for it, given the absence of other symptoms. o Gave Vicodin and nausea medicine Zofran.  Helped somewhat, but headache still continues. o Referred to Kaiser neurologist after the Thanksgiving holiday  Nov. 28th o Still using Vicodin.  Seems to help some, but the headache continues, level 5 or 6 on his scale of 1-10.  He has missed about 10 days of school.  The headache continues.  Each doctor has given the basic "neurological exam"  all have been normal.
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from two pharmacists (one via field representative) refers to a patient of unknown age. On 10-SEP-2013 the patient was vaccinated with ZOSTAVAX vials of lot number J001700 and expiry date 08-MAY-2014. Dose and route were unspecified. The reporter informed that one shipment of improperly stored ZOSTAVAX vials (lot number J001700 and expiry date 08-MAY-2014) received on 27-JUN-2013 were exposed to 5 degrees centigrade for possibly 105 days. The patient had been administered with the improperly stored vaccine. No adverse event was reported. This is 2 of several reports from the same reporter. Additional information has been requested.
Age: 1.26
Sex: F
Vaccine: DTAP, HIBV, PNC13
Symptoms: Erythema migrans, Full blood count, Lyme disease, Lymphocyte morphology abnormal, Rash generalised
Clinical narrative: Pt. had erythema migrans type rash over entire body. Suspicious for and treated as Lyme. However, since the rash appeared 5 days of shot DDx would include reaction.
Age: 1.26
Sex: F
Vaccine: DTAP, HIBV, PNC13
Symptoms: Vaccination complication
Clinical narrative: Pt. had erythema migrans type rash over entire body. Suspicious for and treated as Lyme. However, since the rash appeared 5 days of shot DDx would include reaction.
Age: 44.0
Sex: F
Vaccine: FLUN4
Symptoms: Headache, Myalgia, Vomiting
Clinical narrative: Vomiting, severe headache, muscle pain in extremities - lasted x 2 days. Began 1 day after vax.
Sex: U
Vaccine: FLU3
Symptoms: Acute febrile neutrophilic dermatosis
Clinical narrative: Initial report was received on 20 November 2013 from a health care professional. A physician (gender, age and date of birth not reported) had received an injection of FLUZONE (lot number, route, site and date of administration not reported) and an unspecified amount of time later, was diagnosed with drug induced Sweets syndrome. No further information available at the time of the report. The patient's outcome was not reported. Documents held by sender: none.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Eye swelling, Feeling hot, Hypersensitivity, Rash
Clinical narrative: Six hrs after vax, face became red, blotchy and hot. Rash on neck, shoulders, arms and (L) leg. Face puffy and eyes swollen the next day. Saw PCP - dx with allergic reaction - lasted 5-6 days.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Rash macular, Swelling face
Clinical narrative: Six hrs after vax, face became red, blotchy and hot. Rash on neck, shoulders, arms and (L) leg. Face puffy and eyes swollen the next day. Saw PCP - dx with allergic reaction - lasted 5-6 days.
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Injection site bruising, Injection site swelling
Clinical narrative: (L) upper arm - Bruising at site of injection - Pt. on ASA therapy daily. (L) upper arm - sl. swollen and red below injection site.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered at inappropriate site, Musculoskeletal pain
Clinical narrative: Patient had flu shot on 10/23/2013 and complained about her shoulder pain on 11/9/2013, about 3 wks later. She claimed because the shot was given too high up on her arm close to her shoulder.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: 24 hours later Pt had swollen, slightly painful neck lymph nodes. Pt states it is slowly going away.
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from two pharmacists (one via field representative) refers to a patient of unknown age. On 17-SEP-2013 the patient was vaccinated with ZOSTAVAX vials of lot number J001700 and expiry date 08-MAY-2014. Dose and route were unspecified. The reporter informed that one shipment of improperly stored ZOSTAVAX vials (lot number J001700 and expiry date 08-MAY-2014) received on 27-JUN-2013 were exposed to 5 degrees centigrade for possibly 105 days. The patient had been administered with the improperly stored vaccine. No adverse event was reported. This is 3 of several reports from the same reporter. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. In 2011 ("about 2 years ago"), the patient was vaccinated with a dose of ZOSTAVAX (lot#, expiration date, dose and route not reported). The pharmacist reported that the patient "recently" (in 2013) developed a case of "extremely painful" shingles on her scalp. The patient saw an unspecified healthcare provider, on an unspecified date, that prescribed unspecified antiviral medication and unspecified pain medication for her reaction. The patient was not recovered at report time. This is one of several reports received from the same source. Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacist via a consumer refers to a lot of patients of unknown age. The consumer reported "a lot of her friends" developed shingles on an unknown date after receiving ZOSTAVAX (lot #, expiration date, dose, route and indication not reported) on an unknown date. The outcome of the events was unknown. This is one of several reports received from the same source. Additional information is not expected.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received via company representative from a pharmacist refers to his mother, a patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX, injection (route, strength, dose, lot number and expiration date not provided). On an unknown date the patient got shingles. The outcome of shingles was reported as recovered/resolved within 6 to 8 weeks (dates unspecified). The relatedness between vaccination with ZOSTAVAX and shingles was not reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a physician's assistant refers to a female patient of unknown age. On 27-JUL-2011 the patient was vaccinated with GARDASIL dose 1, on 19-SEP-2012 with dose 2. It was reported that on 22-NOV-2013, the patient would receive the third dose of GARDASIL vaccination series. No adverse effects were reported. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Urticarial rash distal to injection site x 2 yrs in a row.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to 2 separate patients of unknown demographics. On 25-NOV-2013 the 2 separate patients were vaccinated with MMR II, dose 0.5 ml, subcutaneously from lot J006136 and expiry date 24-MAY-2015. No adverse effect was reported. The nurse reported that 2 doses of MMR that were exposed to 17 degrees Centigrade (also reported as out of temperature range) for 8.5 hours. Additional information has been requested.
Age: 81.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report refers to an 81 year old male patient. On an unknown date in 2013, the patient was vaccinated with ZOSTAVAX for shingles vaccination (dose, lot and expiry date were unknown). On an unknown date in approximately October 2013 (reported as a month ago) the patient experienced developed the shingles after receiving ZOSTAVAX. The outcome of event was reported as resolving. The patient was given VALTREX of unspecified dosage as treatment for the event. Lab diagnostics studies performed were done. The patient had seen his physician to seek medical attention. Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from two pharmacists (one via field representative) refers to a patient of unknown age. On 10-SEP-2013 the patient was vaccinated with ZOSTAVAX vials of lot number J001700 and expiry date 08-MAY-2014. Dose and route were unspecified. The reporter informed that one shipment of improperly stored ZOSTAVAX vials (lot number J001700 and expiry date 08-MAY-2014) received on 27-JUN-2013 were exposed to 5 degrees centigrade for possibly 105 days. The patient had been administered with the improperly stored vaccine. No adverse event was reported. This is 1 of several reports from same reporter. Additional information has been requested.
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: Patient stated she experienced redness, swelling and itchiness below the injection site.
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from two pharmacists (one via field representative) refers to a patient of unknown age. On 24-OCT-2013 the patient was vaccinated with ZOSTAVAX vials of lot number J006156 and expiry date 30-AUG-2014. Dose and route were unspecified. The reporter informed that a shipment (referred as second) of improperly stored ZOSTAVAX vials (lot number J006156 and expiry date 30-AUG-2014) received on 11-OCT-2013 were exposed to 5 degrees centigrade for approximately 41 days. The patient had been administered with the improperly stored vaccine. No adverse event was reported. This is 13 of several reports from same reporter. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from two pharmacists (one via field representative) refers to a patient of unknown age. On 9-OCT-2013 the patient was vaccinated with ZOSTAVAX vials of lot number J006156 and expiry date 30-AUG-2014. Dose and route were unspecified. The reporter informed that a shipment (referred as second) of improperly stored ZOSTAVAX vials (lot number J006156 and expiry date 30-AUG-2014) received on 11-OCT-2013 were exposed to 5 degrees centigrade for approximately 41 days. The patient had been administered with the improperly stored vaccine. No adverse event was reported. This is 9 of several reports from same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from two pharmacists (one via field representative) refers to a patient of unknown age. On 21-OCT-2013 the patient was vaccinated with ZOSTAVAX vials of lot number J006156 and expiry date 30-AUG-2014. Dose and route were unspecified. The reporter informed that a shipment (referred as second) of improperly stored ZOSTAVAX vials (lot number J006156 and expiry date 30-AUG-2014) received on 11-OCT-2013 were exposed to 5 degrees centigrade for approximately 41 days. The patient had been administered with the improperly stored vaccine. No adverse event was reported. This is 12 of several reports from same reporter. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from two pharmacists (one via field representative) refers to a patient of unknown age. On 13-NOV-2013 the patient was vaccinated with ZOSTAVAX vials of lot number J006156 and expiry date 30-AUG-2014. Dose and route were unspecified. The reporter informed that a shipment (referred as second) of improperly stored ZOSTAVAX vials (lot number J006156 and expiry date 30-AUG-2014) received on 11-OCT-2013 were exposed to 5 degrees centigrade for approximately 41 days. The patient had been administered with the improperly stored vaccine. No adverse event was reported. This is 14 of several reports from same reporter. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from two pharmacists (one via field representative) refers to a patient of unknown age. On 29-OCT-2013 the patient was vaccinated with ZOSTAVAX vials of lot number J006156 and expiry date 30-AUG-2014. Dose and route were unspecified. The reporter informed that a shipment (referred as second) of improperly stored ZOSTAVAX vials (lot number J006156 and expiry date 30-AUG-2014) received on 11-OCT-2013 were exposed to 5 degrees centigrade for approximately 41 days. The patient had been administered with the improperly stored vaccine. No adverse event was reported. This is 8 of several reports from same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from two pharmacists (one vial field representative) refers to a patient of unknown age. On 06-NOV-2013 the patient was vaccinated with ZOSTAVAX vials of lot number J006156 and expiry date 30-AUG-2014. Dose and route were unspecified. The reporter informed that a shipment (referred as second) of improperly stored ZOSTAVAX vials (lot number J006156 and expiry date 30-AUG-2014) received on 11-OCT-2013 were exposed to 5 degrees centigrade for approximately 41 days. The patient had been administered with the improperly stored vaccine. No adverse event was reported. This is 11 of several reports from same reporter. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from two pharmacists (one via field representative) refers to a patient of unknown age. On 04-NOV-2013 the patient was vaccinated with ZOSTAVAX vials of lot number J006156 and expiry date 30-AUG-2014. Dose and route were unspecified. The reporter informed that a shipment (referred as second) of improperly stored ZOSTAVAX vials (lot number J006156 and expiry date 30-AUG-2014) received on 11-OCT-2013 were exposed to 5 degrees centigrade for approximately 41 days. The patient had been administered with the improperly stored vaccine. No adverse event was reported. This is 10 of several reports from same reporter. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from two pharmacists (one via field representative) refers to a patient of unknown age. On 03-SEP-2013 the patient was vaccinated with ZOSTAVAX vials of lot number J001700 and expiry date 08-MAY-2014. Dose and route were unspecified. The reporter informed that one shipment of improperly stored ZOSTAVAX vials (lot number J001700 and expiry date 08-MAY-2014) received on 27-JUN-2013 were exposed to 5 degrees centigrade for possibly 105 days. The patient had been administered with the improperly stored vaccine. No adverse event was reported. This is 5 of several reports from same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from two pharmacists (one vial field representative) refers to a patient of unknown age. On 11-AUG-2013 the patient was vaccinated with ZOSTAVAX vials of lot number J001700 and expiry date 08-MAY-2014. Dose and route were unspecified. The reporter informed that one shipment of improperly stored ZOSTAVAX vials (lot number J001700 and expiry date 08-MAY-2014) received on 27-JUN-2013 were exposed to 5 degrees centigrade for possibly 105 days. The patient had been administered with the improperly stored vaccine. No adverse event was reported. This is 4 of several reports from same reporter. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from two pharmacists (one via field representative) refers to a patient of unknown age. On 05-OCT-2013 the patient was vaccinated with ZOSTAVAX vials of lot number J001700 and expiry date 08-MAY-2014. Dose and route were unspecified. The reporter informed that one shipment of improperly stored ZOSTAVAX vials (lot number J001700 and expiry date 08-MAY-2014) received on 27-JUN-2013 were exposed to 5 degrees centigrade for approximately 105 days. The patient had been administered with the improperly stored vaccine. No adverse event was reported. This is 6 of several reports from same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from two pharmacists (one via field representative) refers to a patient of unknown age. On 08-OCT-2013 the patient was vaccinated with ZOSTAVAX vials of lot number J001700 and expiry date 08-MAY-2014. Dose and route were unspecified. The reporter informed that one shipment of improperly stored ZOSTAVAX vials (lot number J001700 and expiry date 08-MAY-2014) received on 27-JUN-2013 were exposed to 5 degrees centigrade for possibly 105 days. The patient had been administered with the improperly stored vaccine. No adverse event was reported. This is 7 of several reports from same reporter. Additional information has been requested.
Age: 61.0
Sex: M
Vaccine: FLU3
Symptoms: Ear swelling, Swelling face
Clinical narrative: Patient presented 2 hours after receiving influenza vaccine with facial and earlobe swelling. Prednisone 40 mg BID, Diphenhydramine 50 mg TID, Ranitidine 150 mg BID.
Age: 54.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injected limb mobility decreased, Injection site pain, Pain
Clinical narrative: The actual shot was a little painful.  The pain has increased since the shot.  I am still, 17 days later, experiencing substantial pain and loss of mobility in my left shoulder. Center of pain is injection site.
Age: 54.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injection site pain
Clinical narrative: The actual shot was a little painful.  The pain has increased since the shot.  I am still, 17 days later, experiencing substantial pain and loss of mobility in my left shoulder. Center of pain is injection site.
Age: 35.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema, Injection site irritation, Injection site swelling, Pain
Clinical narrative: This spontaneous report was received from a licensed practical nurse via a company representative concerning a 35 year old female patient with asthma. On 18-NOV-2013, was vaccinated with a dose of PNEUMOVAX23 (lot number, expiry date, dose and route unspecified). No concomitant therapy was reported. On 20-NOV-2013, the patient contacted the healthcare professional (HCP) office stating that she had a fever, full body ache, injection site irritation including swelling and redness. The patient sought medical attention. The patient visited an Urgent Care Center where she was diagnosed with cellulitis and she was prescribed with antibiotics (unspecified). She was not admitted overnight. It was reported that there was a confusion as to when the patient visited the Care Center, before or after calling the HCP. It was unspecified if any lab tests were performed. The outcome of cellulitis was unknown. The relatedness for cellulitis was unknown for PNEUMOVAX23. Additional information has been requested.
Age: 35.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: This spontaneous report was received from a licensed practical nurse via a company representative concerning a 35 year old female patient with asthma. On 18-NOV-2013, was vaccinated with a dose of PNEUMOVAX23 (lot number, expiry date, dose and route unspecified). No concomitant therapy was reported. On 20-NOV-2013, the patient contacted the healthcare professional (HCP) office stating that she had a fever, full body ache, injection site irritation including swelling and redness. The patient sought medical attention. The patient visited an Urgent Care Center where she was diagnosed with cellulitis and she was prescribed with antibiotics (unspecified). She was not admitted overnight. It was reported that there was a confusion as to when the patient visited the Care Center, before or after calling the HCP. It was unspecified if any lab tests were performed. The outcome of cellulitis was unknown. The relatedness for cellulitis was unknown for PNEUMOVAX23. Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Injection site cellulitis, Injection site swelling, Local swelling
Clinical narrative: (R) arm swollen with cellulitis from injection site to elbow 3+ swelling 2 + (R) to wrist.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Local reaction, Skin warm, Swelling
Clinical narrative: Patient presented on 11/29/13 with a local reaction: red, swollen, heated area. Patient referred to ER for check - Patient is opting to wait a few days before seeking treatment.
Sex: U
Vaccine: HPV4
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age. On 21-NOV-2013, the patient was vaccinated with an expired second dose of GARDASIL (Lot # reported as 030GAA, expiration date 10-MAY-2013) (route not reported). No adverse symptoms were reported. Additional information has been requested.
Age: 0.55
Sex: M
Vaccine: DTAPHEPBIP, FLU3, PNC13
Symptoms: Gaze palsy, Hypotonia, Irritability, Muscle twitching, Pallor
Clinical narrative: Mom called nurse advice line on 11/12/13 because child had "twitching yesterday," c/o "some eye rolling today." Examined by Dr. on 11/12/13. Chart note states child was fussy through night, awoke screaming, then limp, eyes rolled back, pale, (R) leg shake x 10 sec. Nomal within 30 minutes.
Age: 0.55
Sex: M
Vaccine: DTAPHEPBIP, FLU3, PNC13
Symptoms: Screaming, Tremor
Clinical narrative: Mom called nurse advice line on 11/12/13 because child had "twitching yesterday," c/o "some eye rolling today." Examined by Dr. on 11/12/13. Chart note states child was fussy through night, awoke screaming, then limp, eyes rolled back, pale, (R) leg shake x 10 sec. Nomal within 30 minutes.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Skin hives, noticed by patient on morning of 11/14/13.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Abdominal pain, Asthenia, Dizziness, Erythema, Generalised erythema
Clinical narrative: Dizziness, blurry vision, abd pain, weakness, redness face/body, nauseous.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Nausea, Vision blurred
Clinical narrative: Dizziness, blurry vision, abd pain, weakness, redness face/body, nauseous.
Age: 0.42
Sex: F
Vaccine: RV5
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Child developed vomiting and diarrhea. ROTATEQ given on 11-12-13.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Reaction at site swelling redness fever 101 degrees.
Age: 90.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Rash
Clinical narrative: Developed a rash on leg 11/15/13 in evening and went to emergency room 11/17. Patient had leg pain also.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Blood pressure increased, Dizziness, Headache, Heart rate increased
Clinical narrative: 10-21-13 3 pm HA's, dizziness, weakness, not feeling well. Symptoms lasted -> 10/25/13. 10/25/13 8:30 pm -> developed fast heart rate, increase B.P. and palpitations. Treated at E.R. (hosp) for malaise, weakness.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Laboratory test, Malaise, Palpitations
Clinical narrative: 10-21-13 3 pm HA's, dizziness, weakness, not feeling well. Symptoms lasted -> 10/25/13. 10/25/13 8:30 pm -> developed fast heart rate, increase B.P. and palpitations. Treated at E.R. (hosp) for malaise, weakness.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Nausea, Swelling, Tenderness
Clinical narrative: Pt went home and got nauseated. It also got swollen and red that same night. It is tender to touch.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Erythema, Fatigue, Injection site swelling, Local swelling
Clinical narrative: Fever, chills, aches, extreme fatigue - 24 hrs. Dehydration and aches, extreme fatigue - 48 hrs. Treatment: ibuprofen and rest and fluids. Swelling of inoculated arm - from upper arm to elbow and below, skin hot and red, tender - 4-5 days duration.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Pain, Pain of skin, Pyrexia, Skin warm
Clinical narrative: Fever, chills, aches, extreme fatigue - 24 hrs. Dehydration and aches, extreme fatigue - 48 hrs. Treatment: ibuprofen and rest and fluids. Swelling of inoculated arm - from upper arm to elbow and below, skin hot and red, tender - 4-5 days duration.
Age: 65.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Inflammation, Pain in extremity
Clinical narrative: Arm is red all over from upper shoulder to elbow. Also inflamed and sore.
Age: 2.0
Sex: M
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, Wrong drug administered
Clinical narrative: No Sx - Patient was given 0.5 ml of multidose Flu (adult) for > 36 mo and pt is only 34 1/2 months.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Vaccination site pain
Clinical narrative: Approximately 1 month after receiving vaccination patient still has quarter-sized bruise. She is also still having pain at vaccination site.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Eye discharge, Eye swelling, Pain, Pharyngeal oedema
Clinical narrative: Fever, eyes swelled and drained fluid, hives, aches, throat swelling/difficulty breathing.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia, Urticaria
Clinical narrative: Fever, eyes swelled and drained fluid, hives, aches, throat swelling/difficulty breathing.
Age: 1.11
Sex: M
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: Fever 102 degrees 2 hrs after vaccine given with fevers 100 degrees - 101 degrees for 24 hrs after vaccine given.
Age: 4.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: Pt was given FLUARIX (IM form of influenza) nasally to left nare - nurses made error thinking it was FLUMIST. No ill effect no adverse symptoms occurred. Mother was with child. Error caught minutes after pt left. Parent notified, state, and appropriate forms filled out.
Age: 1.01
Sex: M
Vaccine: FLU3, MMR, PNC13, VARCEL
Symptoms: Wrong drug administered
Clinical narrative: Immunizations were drawn up by a medical assistant that I work with and I went to assist in administering the immunizations. Administration of vaccincations without difficulty. Realized after administration that Hepatitis B was given instead of Hib that was supposed to be administered.
Age: 38.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Injection site erythema, Injection site pain, Injection site swelling, Local swelling
Clinical narrative: Developed marked local swelling, erythema, and tenderness at the site of immunization (right upper arm) accompanied by paresthesias in the right arm (later in all extremities) and a vessicle on the right shoulder presumed to be active zoster infection.
Age: 38.0
Sex: F
Vaccine: VARZOS
Symptoms: Paraesthesia
Clinical narrative: Developed marked local swelling, erythema, and tenderness at the site of immunization (right upper arm) accompanied by paresthesias in the right arm (later in all extremities) and a vessicle on the right shoulder presumed to be active zoster infection.
Age: 79.0
Sex: M
Vaccine: FLU3
Symptoms: Chest pain, Injection site erythema, Malaise, Nausea, Palpitations
Clinical narrative: Chest pains, racing heartbeat, nausea, "felt terrible", redness at injection site.
Age: 57.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Vaccination complication
Clinical narrative: Patient noticed a red dot after receiving his influenza vaccination and some pain at injection site. One month later he reported the red dot to the vaccine administrator. Two months after receiving the vaccine he visited the MD regarding the "red dot".  He reports the MD said it was a reaction to the influenza vaccine.
Age: 36.0
Sex: M
Vaccine: UNK
Symptoms: Unevaluable event
Clinical narrative: None stated.