chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 13.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Tinnitus, Vision blurred
Clinical narrative: He put his hand over his chest and said, "It must have just reached my heart. I have a pain in my heart." He was quite pale, lips white, and said, "I feel like I'm going to throw up." He felt weak and his hands were very shaky. He said that his heart was racing, his ears were ringing, making it hard to hear, and his vision became slightly blurry. I had him take deep breaths. The symptoms gradually subsided over about 30 minutes.
Age: 13.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Angina pectoris, Asthenia, Hypoacusis, Lip discolouration, Nausea
Clinical narrative: He put his hand over his chest and said, "It must have just reached my heart. I have a pain in my heart." He was quite pale, lips white, and said, "I feel like I'm going to throw up." He felt weak and his hands were very shaky. He said that his heart was racing, his ears were ringing, making it hard to hear, and his vision became slightly blurry. I had him take deep breaths. The symptoms gradually subsided over about 30 minutes.
Age: 13.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Pallor, Tinnitus, Tremor, Vision blurred
Clinical narrative: He put his hand over his chest and said, "It must have just reached my heart. I have a pain in my heart." He was quite pale, lips white, and said, "I feel like I'm going to throw up." He felt weak and his hands were very shaky. He said that his heart was racing, his ears were ringing, making it hard to hear, and his vision became slightly blurry. I had him take deep breaths. The symptoms gradually subsided over about 30 minutes.
Age: 45.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Abortion spontaneous, Exposure during pregnancy
Clinical narrative: Information has been received from a healthcare worker, for VARIVAX (merck), a Pregnancy Registry product, concerning an approximately 45 years old female patient with no pertinent medical history and drug reactions or allergies. On 25-SEP-2012 the patient was vaccinated with a dose of VARIVAX (merck) (lot # 671027/1067AA, exp. date: 05-JUL-2013). Concomitant medications included prenatal vitamins and BENADRYL. It was reported that the patient was found to be 5 weeks pregnant. Reporter mentioned the patient's LMP was 07-FEB-2012 and the date does not match her gestation date. The reporter clarified the patient was currently 5 weeks pregnant and the patient was nursing in February 2012. The estimated EDD was 28-MAY-2013. The patient was exposed to VARIVAX (Merck) during trimester 1. Reporter stated the patient recently got pregnant through in vitro fertilization. No treatment information was reported. No lab diagnostics studies performed. The outcome of the pregnant was unknown. Follow-up information has been received from a physician. The patient miscarriaged (medically significant upon internal review). Additional information is not expected.
Age: 45.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Exposure during pregnancy, Pregnancy test negative, Pregnancy test positive, Vaginal haemorrhage
Clinical narrative: Information has been received from a healthcare worker, for VARIVAX (merck), a Pregnancy Registry product, concerning an approximately 45 years old female patient with no pertinent medical history and drug reactions or allergies. On 25-SEP-2012 the patient was vaccinated with a dose of VARIVAX (merck) (lot # 671027/1067AA, exp. date: 05-JUL-2013). Concomitant medications included prenatal vitamins and BENADRYL. It was reported that the patient was found to be 5 weeks pregnant. Reporter mentioned the patient's LMP was 07-FEB-2012 and the date does not match her gestation date. The reporter clarified the patient was currently 5 weeks pregnant and the patient was nursing in February 2012. The estimated EDD was 28-MAY-2013. The patient was exposed to VARIVAX (Merck) during trimester 1. Reporter stated the patient recently got pregnant through in vitro fertilization. No treatment information was reported. No lab diagnostics studies performed. The outcome of the pregnant was unknown. Follow-up information has been received from a physician. The patient miscarriaged (medically significant upon internal review). Additional information is not expected.
Age: 23.0
Sex: M
Vaccine: TYP
Symptoms: Influenza like illness, Nausea
Clinical narrative: Flu-like symptoms, nausea after 1st pill.
Sex: F
Vaccine: TYP, YF
Symptoms: Body temperature increased, Headache, Hyperhidrosis, Injection site erythema, Injection site induration
Clinical narrative: Initial report was received 13 June 2013 from a consumer. A female patient (age and date of birth not reported) had received an injection of YF VAX and a "TYPHIM" vaccine (other manufacturer) in 1988 (precise date not reported) and three hours later, she woke up sweating profusely. She had a temperature of 105-106 for three days, and also experienced nausea, headache and the injection site became indurated, red and raised. No relevant diagnostic or laboratory testing was performed. The patient had no concurrent illness and no past medical history. Outcome was recovered. Documents held by sender: None.
Sex: F
Vaccine: TYP, YF
Symptoms: Injection site swelling, Nausea
Clinical narrative: Initial report was received 13 June 2013 from a consumer. A female patient (age and date of birth not reported) had received an injection of YF VAX and a "TYPHIM" vaccine (other manufacturer) in 1988 (precise date not reported) and three hours later, she woke up sweating profusely. She had a temperature of 105-106 for three days, and also experienced nausea, headache and the injection site became indurated, red and raised. No relevant diagnostic or laboratory testing was performed. The patient had no concurrent illness and no past medical history. Outcome was recovered. Documents held by sender: None.
Age: 42.0
Sex: F
Vaccine: TDAP
Symptoms: Abdominal pain upper, Asthenia, Blood pressure decreased, Chest discomfort, Dyspnoea
Clinical narrative: 3/13/13 initial headache and "air hunger", VS within normal limits, BP decreased at 1015 when assessed by RN, 1100 took BENADRYL. Nausea, gut ache, weakness set in by 1830, profound weakness neck down and fatigue, pain. 3/14/13 vomited, no food in AM, increased weakness, fatigue, weak from neck down, pain. BENADRYL and TYLENOL 1000mg around the clock. 3/15/13 fatigue/weakness/air hunger/chest tight, went to urgent care 1015 AM. Prednisone - symptoms improved slightly with prednisone, had hives. 3/16/13 hives/flushing, tight chest, increased prednisone 80mg, urgent care 3/17, 3/18 and ongoing medical care to date (3/30 stiff neck, abnormal vaginal bleeding). 3/17/13 severe arm/shoulder pain cont. to present.
Age: 42.0
Sex: F
Vaccine: TDAP
Symptoms: Fatigue, Flushing, Headache, Musculoskeletal pain, Musculoskeletal stiffness
Clinical narrative: 3/13/13 initial headache and "air hunger", VS within normal limits, BP decreased at 1015 when assessed by RN, 1100 took BENADRYL. Nausea, gut ache, weakness set in by 1830, profound weakness neck down and fatigue, pain. 3/14/13 vomited, no food in AM, increased weakness, fatigue, weak from neck down, pain. BENADRYL and TYLENOL 1000mg around the clock. 3/15/13 fatigue/weakness/air hunger/chest tight, went to urgent care 1015 AM. Prednisone - symptoms improved slightly with prednisone, had hives. 3/16/13 hives/flushing, tight chest, increased prednisone 80mg, urgent care 3/17, 3/18 and ongoing medical care to date (3/30 stiff neck, abnormal vaginal bleeding). 3/17/13 severe arm/shoulder pain cont. to present.
Age: 42.0
Sex: F
Vaccine: TDAP
Symptoms: Nausea, Neck pain, Pain, Pain in extremity, Urticaria
Clinical narrative: 3/13/13 initial headache and "air hunger", VS within normal limits, BP decreased at 1015 when assessed by RN, 1100 took BENADRYL. Nausea, gut ache, weakness set in by 1830, profound weakness neck down and fatigue, pain. 3/14/13 vomited, no food in AM, increased weakness, fatigue, weak from neck down, pain. BENADRYL and TYLENOL 1000mg around the clock. 3/15/13 fatigue/weakness/air hunger/chest tight, went to urgent care 1015 AM. Prednisone - symptoms improved slightly with prednisone, had hives. 3/16/13 hives/flushing, tight chest, increased prednisone 80mg, urgent care 3/17, 3/18 and ongoing medical care to date (3/30 stiff neck, abnormal vaginal bleeding). 3/17/13 severe arm/shoulder pain cont. to present.
Age: 42.0
Sex: F
Vaccine: TDAP
Symptoms: Vaginal haemorrhage, Vomiting
Clinical narrative: 3/13/13 initial headache and "air hunger", VS within normal limits, BP decreased at 1015 when assessed by RN, 1100 took BENADRYL. Nausea, gut ache, weakness set in by 1830, profound weakness neck down and fatigue, pain. 3/14/13 vomited, no food in AM, increased weakness, fatigue, weak from neck down, pain. BENADRYL and TYLENOL 1000mg around the clock. 3/15/13 fatigue/weakness/air hunger/chest tight, went to urgent care 1015 AM. Prednisone - symptoms improved slightly with prednisone, had hives. 3/16/13 hives/flushing, tight chest, increased prednisone 80mg, urgent care 3/17, 3/18 and ongoing medical care to date (3/30 stiff neck, abnormal vaginal bleeding). 3/17/13 severe arm/shoulder pain cont. to present.
Age: 0.94
Sex: M
Vaccine: VARCEL
Symptoms: Injection site rash, Rash erythematous, Rash vesicular
Clinical narrative: This spontaneous report was received from a Registered Nurse regarding her son of of approximately 20 months of age. No medical history or drug allergies were reported. On an unknown date in April 2009, the patient was vaccinated with a dose of VARIVAX (Merck) (lot #, expiry not reported), 0.5 ml, subcutaneously. No concomitant medications were reported. On an unknown date in 2010, the patient developed bright red blistered rash. The nurse reported that the rash was localized to her son's left leg starting from his left upper thigh down to his knee. Patient sought medical attention (patient was seen by physician on an unspecified date). The patient was treated with acyclovir on an unspecified date. Laboratory diagnostics studies performed was none. The nurse also reports that the rash took a couple of weeks to resolve. Additional information is not expected.
Sex: U
Vaccine: HEPA, MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to unknown number of patient of unknown age and gender. On an unknown date, the unknown number of patients may have been vaccinated with M-M-R II or VAQTA which was stored at higher than recommended temperatures. No adverse effect reported. Additional information has been requested.
Age: 0.18
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Crying, Irritability
Clinical narrative: Very fussy, crying.
Age: 1.03
Sex: F
Vaccine: HEPA, HIBV, MMRV, PNC13
Symptoms: Injection site vesicles, Rash generalised
Clinical narrative: 6/20/13 mom called and reports has bumps all over and blisters on rt leg where she got her vaccines 2 days ago. Mom instructed to bring child into clinic. Did not come in. Rescheduled to 6/21/13. 6/21/13 appt canceled. 6/24/13 spoke with mom and states bumps went away the next day and no problem now.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to a female patient of unknown age. No medical history was reported. Patient received her first dose of GARDASIL on 04-JUN-2013, her second dose on 24-AUG-2012 and was in office today 21-JUN-2013 to receive her third dose of GARDASIL (lot #, expiry not reported). No concomitant medications were reported. No adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Human papilloma virus test positive, Papilloma viral infection
Clinical narrative: This spontaneous report as received from a consumer refers to 2 unspecified patients of unknown age and gender. On an unknown date the 2 patients received a dose of GARDASIL (lot # not reported) (dose, frequency and route not reported). Concomitant therapy was not reported. On an unknown date the patients had been found to have the Human Papilloma Virus (HPV) types 16 and 18. The reporter did not say they had any illness caused by the types mentioned. At the time of the report the patients outcome was unknown. Additional information is not expected.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site discolouration, Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 72 year old male patient. The patient's relevant medical history, concomitant medications and past drug history are unknown. On 21-JUN-2013 11:30, the patient was vaccinated with a dose of ZOSTAVAX (lot # H018092,expiry:04-JAN-2014) 0.65 ml, subcutaneously. On 22-JUN-2013, the patient called the pharmacist and complained of swelling and red and blue discoloration at the injection site in the left upper arm that started on an unknown date in June 2013. The pharmacist did not know when the swelling and discoloration started. There was no relevant laboratory data. The pharmacist will have the patient come to the pharmacy to examine the site. As of 22-JUN-2013, the patient has discontinued use of ZOSTAVAX  and continues to experience swelling and red and blue discoloration at the injection site. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pruritus
Clinical narrative: This spontaneous report as received from a pharmacist refers to a male patient of unknown age. On 12-JUN-2013 the patient was vaccinated with a dose of ZOSTAVAX (strength, dose, frequency and lot number were not reported). On 13-JUN-2013 the patient experienced itching at the injection site. Patient sought medical attention - he presented to the reporting pharmacist at the pharmacy. The outcome of itching at the injection site was reported as not recovered. The relatedness between itching at the injection site and ZOSTAVAX was not reported. Additional information has been requested.
Age: 64.0
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B surface antigen positive
Clinical narrative: This spontaneous report as received from a physician refers to a 64 year old male patient with none pertinent medical history and drug reactions or allergies. On 07-JUN-2013 the dialysis patient was vaccinated with hepatitis B vaccine (recombinant) (manufacturer unknown) (first dose, route not provided) (lot number, expire date not provided). It was reported that there was a numerous unspecified concomitant medication. On 08-JUN-2013 the patient was found to be positive for hepatitis B surface antigen. The patient was following up on test results (it was reported that on 17-JUN-2013 more test will be done) and sought medical attention. The outcome of hepatitis B surface antigen was unknown. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No information regarding the patient's medical history was provided. On 27-FEB-2013 the patient was vaccinated with dose 1 of GARDASIL. On 13-JUN-2013 the patient received the second dose which was reported to be late. No dosing information or route of administration was provided. No concomitant medication was reported. No symptoms were reported. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion
Clinical narrative: This spontaneous report as received from a pharmacist refers to 66 year old female patient. On 12-JUN-2013 the patient was vaccinated with a dose of ZOSTAVAX (0.65 ml, once, lot # H022153, exp. date 18-MAR-2013 subcutaneously) in the arm. On 12-JUN-2013, shortly after the patient received ZOSTAVAX she experienced huge bruise, 4 inches wide and run down patient's arm. It was reported that patient did not have any other adverse event. The patient sought medical attention via contacting pharmacist by phone. No treatment was given for adverse event. The outcome of patient's adverse event was not reported. The relatedness between ZOSTAVAX and patient's adverse event was not reported. Additional information has been requested.
Age: 1.26
Sex: M
Vaccine: VARCEL
Symptoms: Injection site rash, Rash, Skin lesion
Clinical narrative: This spontaneous report was received from a Registered Nurse refers to a 3 year old male patient. No medical history or drug allergies were reported. On 29-MAR-2011, the patient was vaccinated with a dose of VARIVAX (Merck) (lot # 668602/1273Z, expiry: 30-SEP-2012) 0.5 ml, subcutaneously in the left leg (reported as left thigh). No concomitant medications were reported. On 16-JUN-2013, the patient experienced rash that consisted of lesions on his back and left thigh. Patient sought medical attention: was seen by physician on 19-JUN-2013. Patient was prescribed acyclovir 200 mg three times a day for 5 days on 19-JUN-2013. Laboratory diagnostics studies performed was none. The outcome of rash that consisted of lesions on his back and left thigh was unknown. Additional information has been requested.
Age: 40.0
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative, Incorrect route of drug administration
Clinical narrative: This spontaneous report as received from a pharmacist refers to her husband approximately 40 years of age who was also a physician with hypertension, type 2 diabetes and hypothyroidism. On an unknown date in 1992(reported as in early 1992), the patient was vaccinated with a first dose of RECOMBIVAX HB(Lot number, expiry date, route and dose were not reported). Concomitant therapies included COREG, DIOVAN, HCTZ, metformin, JANUVIA, LIPITOR, SYNTHROID and CYTOMEL. On an unknown date in 1992(reported as fall of 1992), the patient had his titer's drawn for Hepatitis B which were negative and the treatment was two more doses of RECOMBIVAX HB(Lot number, expiry date and dose were not reported)which were given intradermally. Again, on unspecified dates, her husband's titer's were negative each of which were followed up with one more dose of RECOMBIVAX HB(Lot number, expiry dater, route and dose were not reported). The patient had sought medical attention for the events (details unspecified). Approximately on an unknown date in 1992, the initially occurred negative titers was resolved and on an unspecified date, the negative titers which occurred for the second time was resolved. Additional information is not expected.
Age: 0.5
Sex: F
Vaccine: HEP
Symptoms: Antibody test negative, Hepatitis B surface antibody negative, Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report was received from a registered nurse concerning an approximately 21 year old (at the time of adverse event) female patient with no pertinent medical history and no drug reactions or allergies. On 11-MAY-1992, the patient was vaccinated with the first dose of RECOMBIVAX HB (lot number and expiry date unspecified) intramuscularly. On 06-JUL-1992, the patient was vaccinated with the second dose of RECOMBIVAX HB (lot number reported as 1002A2, expiry date unspecified), intramuscularly. On 06-NOV-1992, the patient was vaccinated with the third dose of RECOMBIVAX HB (lot number reported as 1151V, expiry date unspecified) intramuscularly. There were no concomitant medications. On 13-MAY-2013, the patient was tested for titers via routine blood work at a hospital. The results of the blood work were negative for titer. It was reported that the patient would be getting a fourth dose of RECOMBIVAX HB in the near future. The patient sought a medical attention. No treatment was provided. The outcome of negative for titers was unknown. The relatedness for the event was unknown for RECOMBIVAX HB. Additional information has been requested.
Age: 17.0
Sex: M
Vaccine: HPV4
Symptoms: Convulsion, Loss of consciousness
Clinical narrative: This spontaneous report as received from a physician and an office nurse via a field representative refers to a 17 year old male patient. The patient's medical history was unknown. On 17-JUN-2013, the patient received the first injection of GARDASIL, 0.5 ml, (administered intramuscularly). No co-suspected or concomitant medications were reported. On 17-JUN-2013, after receiving the injection with GARDASIL, the patient experienced mild seizures and passed out. Upon internal review, mild seizures and passed out were assessed as medically significant (serious) events. The office nurse reported that the patient had only passed out for a brief minute and recovered. The office nurse and the physician stated that the consumer's condition began to improve without further incident. The patient did not receive treatment for the adverse events. The action taken with GARDASIL was not applicable. A causality assessment was not provided. Additional information has been requested.
Age: 2.0
Sex: M
Vaccine: DTAP, HIBV, PNC
Symptoms: Injection site swelling
Clinical narrative: Pt. received immunization on 6/17, 2:51 pm, in both (L) and (R) thigh. 6/18 Pt. brought in for recheck - swelling left thigh, no fevere or chills. 6/19 Pt. returned for recheck. Swelling both thighs. 6/21/13 Pts mother states child improving.
Age: 17.0
Sex: M
Vaccine: HEPA, MNQ
Symptoms: Immediate post-injection reaction, Pallor, Syncope, Unresponsive to stimuli
Clinical narrative: Client recv'd 2 vaccines, after admin, he immediately fainted, was non-responsive for few seconds, client was instructed to put his head down, was given juice and an ice pack. His BP and pulse were wnl. After a few minutes his color came back and was conversing well. Stated he felt well. Phoned his mother, she came to the health dept. Client and mother were educated on fainting. Mom reports that she faints at any sight of needle. After 45 mins, client was discharged ambulatory with mother.
Age: 29.0
Sex: M
Vaccine: PPV
Symptoms: Blood bilirubin increased, Cellulitis, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: 12 hours after vaccination pt woke up with excruciating pain at injection site (L deltiod), fever, and malaise. 3 days following vaccination erythema and induration developed at injection site. At time of evaluation labs show increase in WBC, left shift, and ultrasound negative for abscess. Diagnosis: cellulitis. No response after 3 doses of PO Bactrim Rx. Admitted to Inpatient Care 6/23/13 for pain management and IV clindamycin Rx.
Age: 29.0
Sex: M
Vaccine: PPV
Symptoms: Malaise, Pyrexia, Ultrasound scan normal, White blood cell count increased
Clinical narrative: 12 hours after vaccination pt woke up with excruciating pain at injection site (L deltiod), fever, and malaise. 3 days following vaccination erythema and induration developed at injection site. At time of evaluation labs show increase in WBC, left shift, and ultrasound negative for abscess. Diagnosis: cellulitis. No response after 3 doses of PO Bactrim Rx. Admitted to Inpatient Care 6/23/13 for pain management and IV clindamycin Rx.
Age: 61.0
Sex: M
Vaccine: TDAP
Symptoms: Mastication disorder, Middle insomnia, Pain in jaw
Clinical narrative: Client recvd Tdap vaccine on 6/25/13. He seemed fine, but was woken up at 2am with extreme jaw pain. He took 2 aspirin with no relief after 30 mins, he took an ibuprofen. Client was able to fall asleep again. This morning he woke up with little improvement. He states his jaw still hurts and it is difficult chewing his breakfast. Advise client to go to his physician for further evaluation, as this is not a typical symptom after vaccine. He stated he will wait a few hours to see if symptoms improve. If not improvement or worsening symptoms, he will go to his doctor or walk-in clinic.
Age: 24.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Induration, Tenderness
Clinical narrative: 9cm x 5cm area of induration, erythema, tenderness.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Cellulitis, Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: Right deltoid where vaccines were given - Tdap and MCV - with erythema and edema, warmth approx 8 hours after vaccines which progressed over the next 24 hours. Suspected cellulitis so started of KEFLEX 500mg BID x 10 days and BENADRYL 25mg TID x 3 days.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Erythema, Oedema peripheral
Clinical narrative: Significant arm swelling and erythema.
Age: 54.0
Sex: F
Vaccine: HEPAB
Symptoms: Hypersensitivity, Immune system disorder, Incorrect dose administered, No therapeutic response, Oedema peripheral
Clinical narrative: Patient states arm rt deltoid became increasingly painful and swollen.  Unable to sleep on that are due to pain. She stated that she has a "fickle" immune system that has required treatment before for other reactions.  She may have a yeast allergy.  She was referred to her doctor because of the immune system concerns.
Age: 54.0
Sex: F
Vaccine: HEPAB
Symptoms: Pain in extremity, Tenderness
Clinical narrative: Patient states arm rt deltoid became increasingly painful and swollen.  Unable to sleep on that are due to pain. She stated that she has a "fickle" immune system that has required treatment before for other reactions.  She may have a yeast allergy.  She was referred to her doctor because of the immune system concerns.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Presyncope
Clinical narrative: Patient had a vasovagal episode after receiving vaccines.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Neuralgia, Varicella virus test positive
Clinical narrative: Developed tremendous nerve pain in the arms, and blisters.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Erythema, Injected limb mobility decreased, Pyrexia, Rash
Clinical narrative: 6/24/13 occurred 1 hour after injection. Pt. c/o redness, swelling, inability to move (R) arm, fever, chills, rash.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Swelling
Clinical narrative: 6/24/13 occurred 1 hour after injection. Pt. c/o redness, swelling, inability to move (R) arm, fever, chills, rash.
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site inflammation
Clinical narrative: Within 24 hrs of applied, mother noticed inflammation over (L) deltoid area. Patient doing well. No tingling, numbness or weakness.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Biopsy skin, Granuloma
Clinical narrative: Granulomatous inflam.
Age: 0.39
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC13
Symptoms: Injection site rash
Clinical narrative: 10 mins after receiving 4 mos immz client developed localized rash below the knee bilaterally to anterior legs. FOC stated client received 2 mos immz. and no Rxn developed. Client observed in clinic: Temp 97.1, no difficulty breathing, no swelling to face or extremities. Within 10 mins of observation rash began to clear on Rt. leg. No Tx needed informed parents on s/sx of allergic Rxn; instructed parents to continue to observe client and if s/sx develop to take client to ER. Parents acknowledged understanding and agreed.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to two patients of unknown age and gender. No information regarding the patients medical history was provided. On unknown dates the patients were vaccinated with ZOSTAVAX. No concomitant medication was reported. On unknown dates the patients experienced shingles even though they received vaccination. No outcome was reported. No causality assessment was provided. Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Blood count abnormal, Headache, Pain
Clinical narrative: This spontaneous report as received from a 73 years old female patient with no drug allergies/drug reactions. The patient no longer had a thyroid. On 02-JUN-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiry date, route and dose were not reported) in the left arm. Concomitant therapies included SYNTHROID. On 03-JUN-2013, the patient experienced weakness, headache, pain throughout her body and her blood count went to "1". The patient sought medical attention, went to a hospital and was treated (treatment details unspecified) in the emergency room and was released. No diagnosis was made. Hospital physicians referred her to hematologist and gynecologist for further evaluation. At the time of the report the patient stated that her symptoms were the same. She went to the gynecologist, no diagnosis was made. She has not contacted her primary physician who prescribed the vaccine yet. She has not gone to the hematologist either. The outcome of weakness, headache, her blood count went to '1' and pain throughout her body was reported as not recovered/not resolved.
Age: 61.0
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 61 year old patient of unknown gender. No medical history provided. On 02-APR-2013 the patient was vaccinated with ZOSTAVAX (dosing, frequency, indication; lot # H018510, exp 15-JAN-2014). The vaccine had been improperly stored at minus 5C since 14-FEB-2013. Unknown whether the patient had been using any concomitant medications. No adverse event was reported. Additional information has been requested.
Age: 62.0
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 62 year old patient of unknown gender. No medical history provided. On 09-MAY-2013 the patient was vaccinated with ZOSTAVAX (dosing, frequency, indication; lot #J000492, exp 19-JAN-2014). The vaccine had been improperly stored at minus 5C since 16-APR-2013. Unknown whether the patient had been using any concomitant medications. No adverse event was reported. Additional information has been requested.
Age: 68.0
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 68 year old patient of unknown gender. No medical history provided. On 06-MAY-2013 the patient was vaccinated with ZOSTAVAX (dosing, frequency, indication; lot # J000492, exp 19-JAN-2014). The vaccine had been improperly stored at minus 5C since 16-APR-2013. Unknown whether the patient had been using any concomitant medications. No adverse event was reported. Additional information has been requested.
Age: 65.0
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 65 year old patient of unknown gender. No medical history provided. On 06-MAY-2013 the patient was vaccinated with ZOSTAVAX (dosing, frequency, indication; lot # H018510, exp 15-JAN-2014). The vaccine had been improperly stored at minus 5C since 14-FEB-2013. Unknown whether the patient had been using any concomitant medications. No adverse event was reported. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This spontaneous prospective pregnancy report as received from a physician refers to a 20 years old female patient. The patient became pregnant with LMP (Last menstrual period) of 29-APR-2013 and EDD (estimated date of delivery) of 03-FEB-2014. On 24-JUN-2013, the patient was vaccinated with VARIVAX (Merck) (lot number, expiry date, route and dose were not reported) while she was pregnant and hence the patient had vaccine exposure during first trimester of pregnancy. No adverse event reported. The patient sought medical attention (details unspecified). The pregnancy outcome was unknown (outcome pending). Additional information has been requested.
Age: 64.0
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 64 year old patient of unknown gender. No medical history provided. On 15-APR-2013 the patient was vaccinated with ZOSTAVAX (dosing, frequency, indication; lot # H018510, exp 15-JAN-2014). The vaccine had been improperly stored at minus 5C since 14-FEB-2013. Unknown whether the patient had been using any concomitant medications. No adverse event was reported. Additional information has been requested.
Age: 66.0
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 66 year old patient of unknown gender. No medical history provided. On 29-APR-2013 the patient was vaccinated with ZOSTAVAX (dosing, frequency, indication; lot # J000492, exp 19-JAN-2014). The vaccine had been improperly stored at minus 5C since 16-APR-2013. Unknown whether the patient had been using any concomitant medications. No adverse event was reported. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a female licensed practical nurse via company representative refers to herself. On an unknown date the patient was vaccinated with VARIVAX (Merck) (lot number not provided). The patient had contracted the shingles from years of administering the VARIVAX (Merck) vaccine. The nurse no longer administered VARIVAX (Merck). The outcome of adverse event was not provided. It was unspecified if the patient had sought medical attention. Additional information has been requested.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Hypersensitivity, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 71 year old male patient. On 04-JUN-2013 the patient was vaccinated with ZOSTAVAX (lot# unknown) 0.65 ml subcutaneous in the right arm. No other co-suspects were reported. No concomitant medications were reported. The reporter stated that client was vaccinated with ZOSTAVAX on 04-JUN-2013 and developed adverse events of redness, itching and burning at the injection site. Pharmacist stated client went to local emergency room, unspecified name, on 07-JUN-3013, with what he thought was allergic reaction; redness, itching, and burning at injection site. At the emergency room client was given a injection and 2 different unspecified pills. Client was not hospitalized. Pharmacist stated client now had a upset stomach and still has redness at the injection site. Action was not provided. Additional information is not expected.
Age: 0.2
Sex: U
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from nurse practitioner concerning a 3 month old patient of unknown gender. On 21-JUN-2013, the patient was inadvertently vaccinated with a pediatric dose (0.5 milliliter) of VAQTA (lot number and expiry date unspecified), intramuscularly. No concomitant medications were reported. No adverse effects were reported. Additional information has been requested.
Age: 62.0
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 62 year old patient of unknown gender. No medical history provided. On 06-MAY-2013 the patient was vaccinated with ZOSTAVAX (dosing, frequency indication; lot # J000492, exp 19-JAN-2014). The vaccine had been improperly stored at minus 5C since 16-APR-2013. Unknown whether the patient had been using any concomitant medications. No adverse event was reported. Additional information has been requested.
Age: 61.0
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 61 year old patient of unknown gender. No medical history provided. On 17-APR- 2013 the patient was vaccinated with ZOSTAVAX (dosing, frequency, indication; lot # H018510, exp 15-JAN-2014). The vaccine had been improperly stored at minus 5C since 14-FEB-2013. Unknown whether the patient had been using any concomitant medications. No adverse event was reported. Additional information has been requested.
Age: 72.0
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 72 year old patient of unknown gender. No medical history provided. On 27-MAR-2013 the patient was vaccinated with ZOSTAVAX (dosing, frequency, indication; lot # H018510), exp 15-JAN-2014). The vaccine had been improperly stored at minus 5C since 14-FEB-2013. Unknown whether the patient had been using any concomitant medications. No adverse event was reported. Additional information has been requested.
Age: 77.0
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 77 year old patient of unknown gender. No medical history provided. On 14-MAY-2013 the patient was vaccinated with ZOSTAVAX (dosing, frequency, indication; lot # J000492, exp 19-JAN-2014). The vaccine had been improperly stored at minus 5C since 16-APR-2013. Unknown whether the patient had been using any concomitant medications. No adverse event was reported. Additional information has been requested.
Age: 58.0
Sex: F
Vaccine: RAB
Symptoms: Rash generalised, Urticaria
Clinical narrative: The patient developed red bumps "hives" all over her body. She is treated with BENADRYL. This started after her 4th Novortis Rabies vaccines on 6/12/13. Before she receives her fourth vaccine on 6/19/13, she will be premedicated with BENADRYL and her epi-pen at home.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Muscle twitching
Clinical narrative: Mom called 6/26/13 stating patient had swelling, tenderness, redness of muscle where he received his meningitis vaccine. Mom states it began day after it was given and lasted till 6/24/13 when it finally resolved. Mom states patient told her that his muscle also felt like it was twitching but usually mom could not see anything. Mom states Ibuprofen was given and symptoms resolved. Patient had no fever.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: (R) leg swollen, red and tender.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Local swelling, Pain, Skin warm
Clinical narrative: Patient came into the pharmacy on 6-24 at approximately 8:50pm stating she had received a shingles vaccine. She said it was sore, red, and felt warm. I looked at the back of her arm and could see a red swollen area that was warm to the touch. She said it started to feel sore on Sunday and was not getting better. I recommended she contact her primary physician.
Age: 37.0
Sex: F
Vaccine: HEP, MMR, VARCEL
Symptoms: Erythema, Fatigue, Malaise, Oedema peripheral
Clinical narrative: Both arms are swollen and red feeling fatigue and hasn't been feeling well since the vaccines were administered.
Age: 63.0
Sex: F
Vaccine: TYP, VARZOS
Symptoms: Injection site bruising, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Client reports 24 hours after immunizations, area over tricep (L) became red and swollen circle, size of quarter: Next day symptoms remained. Area a bit redder and warm to touch. Today client reports area improving less red. Smaller in diameter. Client reports typhoid left area bruised, size of dime.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Asthenia, Chills, Decreased appetite, Injection site pain, Pain
Clinical narrative: Pt. reported injection site soreness following immunization around 11AM on 6/26/13. Pt. experienced chills, achy all over, weak "hard to get up", felt feverish but no documented temperature measured, loss of appetite.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Pyrexia, Somnolence
Clinical narrative: Pt. reported injection site soreness following immunization around 11AM on 6/26/13. Pt. experienced chills, achy all over, weak "hard to get up", felt feverish but no documented temperature measured, loss of appetite.
Age: 11.0
Sex: M
Vaccine: HPV4, MEN, TDAP
Symptoms: Nausea, Syncope
Clinical narrative: Patient was given the shot in one of the exam rooms. He was then sent back to the lab for blood work. As he approached the lab he became very nauseous. We led him to the restroom where he fainted. One of the lab techs caught him and laid him down.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Chills, Erythema, Injection site erythema, Oedema peripheral
Clinical narrative: Per MD note on 5/24/13. 66F with h/o HTN p/w swollen, red arm 1 day after receiving pneumococcal vaccine at that site to ED. She is an otherwise healthy woman who had the pneumococcal vaccine administered at noon yesterday. Several hours after receiving the vaccine she developed chills and fever to 101.3. She took ibuprofen which brought it down. She did not have any skin symptoms at that time. The morning of 5/24/13 she began to develop redness at the site of the injection which spread over the course of the day to cover most of her upper arm. The arm also began to swell and feel warm. Her fever also returned this afternoon. She initially presented to her local Urgent Care clinic who recommended she come to the ED. She has no redness or swelling elsewhere, no sick contacts, no history of allergy to vaccines, no CP, SOB, abdominal pain, N/V/D or dysuria and otherwise has been well. Likely cellulitis from recent trauma of injection. No sign of abscess. Will start Bactrim/Keflex and d/c to outpt f/u with PCP on Monday. Pt was instructed to let physician now about injection so that they may tell they vaccination provider and eval for any infected lot of vaccinations.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia, Skin warm
Clinical narrative: Per MD note on 5/24/13. 66F with h/o HTN p/w swollen, red arm 1 day after receiving pneumococcal vaccine at that site to ED. She is an otherwise healthy woman who had the pneumococcal vaccine administered at noon yesterday. Several hours after receiving the vaccine she developed chills and fever to 101.3. She took ibuprofen which brought it down. She did not have any skin symptoms at that time. The morning of 5/24/13 she began to develop redness at the site of the injection which spread over the course of the day to cover most of her upper arm. The arm also began to swell and feel warm. Her fever also returned this afternoon. She initially presented to her local Urgent Care clinic who recommended she come to the ED. She has no redness or swelling elsewhere, no sick contacts, no history of allergy to vaccines, no CP, SOB, abdominal pain, N/V/D or dysuria and otherwise has been well. Likely cellulitis from recent trauma of injection. No sign of abscess. Will start Bactrim/Keflex and d/c to outpt f/u with PCP on Monday. Pt was instructed to let physician now about injection so that they may tell they vaccination provider and eval for any infected lot of vaccinations.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Heart rate increased, Hypoaesthesia oral, Pharyngeal hypoaesthesia, Throat tightness
Clinical narrative: Throat feel tight, feels numb at back of tongue and throat, fast heartbeat.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Oropharyngeal pain, Rash papular, Swollen tongue
Clinical narrative: 2-3 red bumps with "heads".  Sore throat and swollen tongue.  No treatment.
Age: 4.0
Sex: M
Vaccine: DTAP, MMR, VARCEL
Symptoms: Loss of consciousness, Rash, Urticaria
Clinical narrative: Pt broke out in rash/hives and then passed out.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling at injection site.
Age: 31.0
Sex: F
Vaccine: HEP, MMR, TDAP, VARCEL
Symptoms: Discomfort, Erythema, Local swelling, Pain, Skin warm
Clinical narrative: 2 inch diameter raised, red, warm welt-like reaction.  Pt describes as uncomfortable and slightly painful.  States a hx of chicken pox, but due to enrollment in nursing school was told she had to get a varicella vaccine.
Age: 31.0
Sex: F
Vaccine: HEP, MMR, TDAP, VARCEL
Symptoms: Urticaria
Clinical narrative: 2 inch diameter raised, red, warm welt-like reaction.  Pt describes as uncomfortable and slightly painful.  States a hx of chicken pox, but due to enrollment in nursing school was told she had to get a varicella vaccine.
Age: 18.0
Sex: M
Vaccine: HEPA, HPV4, MNQ, VARCEL
Symptoms: Blindness transient, Chromatopsia, Feeling abnormal, Feeling cold, Hyperhidrosis
Clinical narrative: Client had reaction to vaccines after walking out to front desk to check out. Diaphoretic, pale, bp/pulse thready @ 77/23, stated he felt like he was in a tunnel. Stated he could not see. When questioned further he stated he could not see anything at all. tried to keep calm. Cool compress applied and fanned and stated some relief but remains very pale and cool. Lips pale, color greenish hue. Squad called after he stated he could not see and by the time they arrived his sight had returned, first with shades of gray then blurry images and then full sight. Vitals by squad 108/76 with pulse ox of 98%. Color returned, stated he felt much better, walked around the room by sqaud personnel. Dad declined services of squad to transport to ER for further evaluation. His wife is a nurse at the hospital and he called her and he is going to take him there to see her and follow up if needed. Client had good color and alert and oriented when he left the premises.
Age: 18.0
Sex: M
Vaccine: HEPA, HPV4, MNQ, VARCEL
Symptoms: Pallor, Pulse abnormal, Vision blurred
Clinical narrative: Client had reaction to vaccines after walking out to front desk to check out. Diaphoretic, pale, bp/pulse thready @ 77/23, stated he felt like he was in a tunnel. Stated he could not see. When questioned further he stated he could not see anything at all. tried to keep calm. Cool compress applied and fanned and stated some relief but remains very pale and cool. Lips pale, color greenish hue. Squad called after he stated he could not see and by the time they arrived his sight had returned, first with shades of gray then blurry images and then full sight. Vitals by squad 108/76 with pulse ox of 98%. Color returned, stated he felt much better, walked around the room by sqaud personnel. Dad declined services of squad to transport to ER for further evaluation. His wife is a nurse at the hospital and he called her and he is going to take him there to see her and follow up if needed. Client had good color and alert and oriented when he left the premises.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Anxiety, Blood test, Condition aggravated, Diarrhoea, Electrocardiogram
Clinical narrative: Vomiting and diarrhea, then over a week progressed ot fever (101) bodyaches, migraine, tremors, increased anxiety, visual changes, "zoning out".
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Feeling abnormal, Migraine, Pain, Pyrexia, Tremor
Clinical narrative: Vomiting and diarrhea, then over a week progressed ot fever (101) bodyaches, migraine, tremors, increased anxiety, visual changes, "zoning out".
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Visual impairment, Vomiting
Clinical narrative: Vomiting and diarrhea, then over a week progressed ot fever (101) bodyaches, migraine, tremors, increased anxiety, visual changes, "zoning out".
Age: 2.0
Sex: F
Vaccine: PPV
Symptoms: Condition aggravated, Convulsion, Injection site cellulitis, Injection site erythema, Intensive care
Clinical narrative: Redness of thigh at injection site that progressed to cellulitis requiring hospital admission and IV antibiotics. She had increased seizures due to fever/illness, so she was initially admitted to the pediatric ICU.
Age: 2.0
Sex: F
Vaccine: PPV
Symptoms: Malaise, Pyrexia
Clinical narrative: Redness of thigh at injection site that progressed to cellulitis requiring hospital admission and IV antibiotics. She had increased seizures due to fever/illness, so she was initially admitted to the pediatric ICU.
Age: 3.0
Sex: M
Vaccine: VARCEL
Symptoms: Full blood count normal, Petechiae, Platelet count normal
Clinical narrative: Developed petechiae on upper ear lobes and elbows on and off 2 weeks after receiving Varivax.
Age: 70.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness and swelling around injection site including most of the upper arm.  Area is warm to the touch.