chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Electrocardiogram abnormal, Heart rate irregular, Supraventricular extrasystoles
Clinical narrative: Case called office shortly after vaccine administered. States "I have had a significant increase in PAC's (pre atrial contractions) or atrial ectopic beats since getting the vaccine and I don't know if its related or not. I know companies do post marketing research on vaccines. I looked it up and didn't see this as a side effect. I asked case if he had any SOB wheezing, pain or swelling and he denied all. Instructed in SE of severe reaction and when to seek emergency attention and to please call me the next day to follow up or I would call him. I spoke to case on 9/1713 at 10 AM and case stated that "my PAC's got worse as the day went on at several per minute per ECG but I did not go into Afib". I do have a history of Afib. When asked if he went to ER or to primary MD case stated he had his own ECG machine at home which he purchased previously after having episodes of Afib. Case reports pulse was 68 and BP 135/78. Case denies any redness, swelling, pain, itching at site or any other rashes. Denies having any PAC's today. Informed case that I would file VAERS form.TC to case at 3 PM 9/17/13 to get information on previous medical hx and med's. Case reports feeling fine now. Meds: Amlodipine 5 mg qd, Losartan, 100 mg qd, Finasteride 5 mg qd, Prevacid 60mg qd, Atenolol 25-50 mg PRN for irregular heartbeat. Case did take Atenolol yesterday.
Age: 28.0
Sex: F
Vaccine: MMRV
Symptoms: Accidental exposure to product, No adverse event
Clinical narrative: Information has been received through a Merck pregnancy registry from a 28 year old female licensed practical nurse with a history of chickenpox and no other pertinent medical history, no history of immunocompromise, and no known drug allergies who on 02-FEB-2007 was vaccinating a child with a dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (+) varicella virus vaccine live (Oka/Merck upgrade process) (lot # 655140/0832F). There was no concomitant medication. The child wiggled and the needle came out and the vaccine liquid ricocheted from the child's leg into the reporter's right eye. It was noted that the reporter was 20 weeks pregnant and that she had a "high risk pregnancy". She flushed her right eye with water and was not experiencing any problems or symptoms at the time of the report. Unspecified medical attention was sought. Additionally, the reporter did not revaccinate the child because most of the vaccine was already administered and she was nearly finished. A product quality complaint was not involved.  Additional information has been requested. Follow-up has been received from a register nurse who stated that the patient has her baby and her pregnancy was uneventful. Also the patient delivered a baby girl with no congenital anomalies and no health problems that the reported was aware of. No further information is available.
Sex: M
Vaccine: PPV
Symptoms: Injection site rash, Injection site swelling
Clinical narrative: This spontaneous report was received from a doctor of pharmacy concerning a male patient of unknown age. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX23 (lot number, expiry date, dose and route unspecified). No concomitant therapy was reported. On an unknown date, the patient experienced a localized rash and swelling around the injection site after receiving PNEUMOVAX23. The outcome of localized rash and swelling around the injection site was unknown. The relatedness for localized rash and swelling around the injection site was unknown for PNEUMOVAX23. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Adverse reaction
Clinical narrative: This spontaneous report as received from an other, refers to a female patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX (lot # J000430, expiration date 10-APR-2013) (dose and route were reported). Concomitant medications were not reported. On an unknown date the patient experienced an adverse reaction to ZOSTAVAX. The outcome of the adverse reaction was unknown. The relationship between the ZOSTAVAX and the adverse reaction was not reported. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive, Smear cervix abnormal
Clinical narrative: This spontaneous report as received from the patient's mother refers to her 19 year old daughter in Middle School. On an unknown date the patient was vaccinated with a dose of GARDASIL (lot #, expiration, dose unspecified). Concomitant medication included unspecified birth control. Recently a Routine PAP Smear in June 2013 tested positive for HPV 16 or 18. The reporter noted that they had produced vigilance in adhering to the recommended schedule for each dose within the series. Because her daughter was over the age of eighteen, the reporter noted, she did not have additional details of the PAP Smear results. The patient had not sought medical attention. No treatment was given. The event outcome was reported as not improved. Additional information is not expected.
Age: 77.0
Sex: F
Vaccine: FLU3, PPV, FLUX, PPV
Symptoms: Feeling abnormal, Injection site erythema, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Swelling and red.
Age: 77.0
Sex: F
Vaccine: FLU3, PPV, FLUX, PPV
Symptoms: Erythema, Swelling
Clinical narrative: Swelling and red.
Age: 58.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Allergy to vaccine, Cough, Dyspnoea, Pain, Scleral hyperaemia
Clinical narrative: None stated.
Age: 58.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Throat irritation
Clinical narrative: None stated.
Age: 58.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None stated.
Age: 19.0
Sex: F
Vaccine: SMALL
Symptoms: Asthenia, Blood creatine phosphokinase MB, Chest X-ray normal, Chest pain, Electrocardiogram normal
Clinical narrative: The pt received her primary SPV on 8/16/13 in her upper left arm. She was in her normal state of good health at the time of vaccination. She does have a recent hx of insomnia (difficulty falling asleep and staying asleep which she attributes to personal issues). On 8/17/13: she noted sniffles and sneezing with no other sx. On 8/18/13 she noted generalized malaise and sniffles. She denied local site reaction symptoms (erythema, swelling, lymphadenopathy). On 8/19/13 when she woke and sat up she noted "soreness" (rated as a 3/10) across her upper sternum which increased slightly with deep breaths and palpation; she continued with her normal routine (she thought that the discomfort/"soreness" was from sleeping on her stomach). While at work at 0815 she noted an increase in the soreness to a 6 which lasted about 5 minutes. She felt "hot and weak" and the pain increased with deep breaths. When she was triaged in the ER at 0922 her discomfort was a 4/5. She had a negative Troponin (0.012ng/ml), normal CXR, and an EKG which showed NSR with no ST elevation. She took 800mg MOTRIN at 1600 and when she woke from a nap her pain was a 1/10. On 8/20/13 she still had the sniffles and she had a headache (frontal and temples; 2/10; described as annoying which she attributed to a lack of sleep) and "chest" discomfort (1/10) upper 1/4th of the sternum which increased slightly with deep breath and palpation. The patient denied a hx of GERD, reflux, or recent indigestion. She reported that the staff in the Immunization Clinic had started "circuit workouts" the previous week. She denied palpitations and the discomfort was non-positional. The lateral aspect of the upper sternum was tender to palpation. She was instructed to take 800mg of MOTRIN tid with food and was given a no PT chit until her follow-up apt on 8/29/13. On 8/29/13 she reported that she experienced 1/10 chest soreness which increased with deep breaths, palpation to her upper sternal borders and lying on her stomach until 8/23/13 at which time her previous symptoms (headache, chest soreness, malaise) resolved. The patient stopped taking the MOTRIN on 8/23/13. The patient states that her "sniffles" have almost resolved. The patient did note a small amount of erythema (1cm) around the vaccination site and mild axillary lymph node tenderness which started on 8/22/13. There was no tenderness noted to the upper sternal border when palpated. It is the consensus of VHC expert opinion that the patient's condition does not meet the case definition of pericarditis or myocarditis but was non-cardiac in nature possibly related to costochondritis-- possibly an inflammatory response from the SPV or the patient's recent expanded exercise regimen.
Age: 19.0
Sex: F
Vaccine: SMALL
Symptoms: Feeling hot, Headache, Lymph node pain, Malaise, Painful respiration
Clinical narrative: The pt received her primary SPV on 8/16/13 in her upper left arm. She was in her normal state of good health at the time of vaccination. She does have a recent hx of insomnia (difficulty falling asleep and staying asleep which she attributes to personal issues). On 8/17/13: she noted sniffles and sneezing with no other sx. On 8/18/13 she noted generalized malaise and sniffles. She denied local site reaction symptoms (erythema, swelling, lymphadenopathy). On 8/19/13 when she woke and sat up she noted "soreness" (rated as a 3/10) across her upper sternum which increased slightly with deep breaths and palpation; she continued with her normal routine (she thought that the discomfort/"soreness" was from sleeping on her stomach). While at work at 0815 she noted an increase in the soreness to a 6 which lasted about 5 minutes. She felt "hot and weak" and the pain increased with deep breaths. When she was triaged in the ER at 0922 her discomfort was a 4/5. She had a negative Troponin (0.012ng/ml), normal CXR, and an EKG which showed NSR with no ST elevation. She took 800mg MOTRIN at 1600 and when she woke from a nap her pain was a 1/10. On 8/20/13 she still had the sniffles and she had a headache (frontal and temples; 2/10; described as annoying which she attributed to a lack of sleep) and "chest" discomfort (1/10) upper 1/4th of the sternum which increased slightly with deep breath and palpation. The patient denied a hx of GERD, reflux, or recent indigestion. She reported that the staff in the Immunization Clinic had started "circuit workouts" the previous week. She denied palpitations and the discomfort was non-positional. The lateral aspect of the upper sternum was tender to palpation. She was instructed to take 800mg of MOTRIN tid with food and was given a no PT chit until her follow-up apt on 8/29/13. On 8/29/13 she reported that she experienced 1/10 chest soreness which increased with deep breaths, palpation to her upper sternal borders and lying on her stomach until 8/23/13 at which time her previous symptoms (headache, chest soreness, malaise) resolved. The patient stopped taking the MOTRIN on 8/23/13. The patient states that her "sniffles" have almost resolved. The patient did note a small amount of erythema (1cm) around the vaccination site and mild axillary lymph node tenderness which started on 8/22/13. There was no tenderness noted to the upper sternal border when palpated. It is the consensus of VHC expert opinion that the patient's condition does not meet the case definition of pericarditis or myocarditis but was non-cardiac in nature possibly related to costochondritis-- possibly an inflammatory response from the SPV or the patient's recent expanded exercise regimen.
Age: 19.0
Sex: F
Vaccine: SMALL
Symptoms: Rhinorrhoea, Sneezing, Tenderness, Troponin I normal, Vaccination site erythema
Clinical narrative: The pt received her primary SPV on 8/16/13 in her upper left arm. She was in her normal state of good health at the time of vaccination. She does have a recent hx of insomnia (difficulty falling asleep and staying asleep which she attributes to personal issues). On 8/17/13: she noted sniffles and sneezing with no other sx. On 8/18/13 she noted generalized malaise and sniffles. She denied local site reaction symptoms (erythema, swelling, lymphadenopathy). On 8/19/13 when she woke and sat up she noted "soreness" (rated as a 3/10) across her upper sternum which increased slightly with deep breaths and palpation; she continued with her normal routine (she thought that the discomfort/"soreness" was from sleeping on her stomach). While at work at 0815 she noted an increase in the soreness to a 6 which lasted about 5 minutes. She felt "hot and weak" and the pain increased with deep breaths. When she was triaged in the ER at 0922 her discomfort was a 4/5. She had a negative Troponin (0.012ng/ml), normal CXR, and an EKG which showed NSR with no ST elevation. She took 800mg MOTRIN at 1600 and when she woke from a nap her pain was a 1/10. On 8/20/13 she still had the sniffles and she had a headache (frontal and temples; 2/10; described as annoying which she attributed to a lack of sleep) and "chest" discomfort (1/10) upper 1/4th of the sternum which increased slightly with deep breath and palpation. The patient denied a hx of GERD, reflux, or recent indigestion. She reported that the staff in the Immunization Clinic had started "circuit workouts" the previous week. She denied palpitations and the discomfort was non-positional. The lateral aspect of the upper sternum was tender to palpation. She was instructed to take 800mg of MOTRIN tid with food and was given a no PT chit until her follow-up apt on 8/29/13. On 8/29/13 she reported that she experienced 1/10 chest soreness which increased with deep breaths, palpation to her upper sternal borders and lying on her stomach until 8/23/13 at which time her previous symptoms (headache, chest soreness, malaise) resolved. The patient stopped taking the MOTRIN on 8/23/13. The patient states that her "sniffles" have almost resolved. The patient did note a small amount of erythema (1cm) around the vaccination site and mild axillary lymph node tenderness which started on 8/22/13. There was no tenderness noted to the upper sternal border when palpated. It is the consensus of VHC expert opinion that the patient's condition does not meet the case definition of pericarditis or myocarditis but was non-cardiac in nature possibly related to costochondritis-- possibly an inflammatory response from the SPV or the patient's recent expanded exercise regimen.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Bloody discharge, Deafness, Ear pain, Herpes zoster, Varicella virus test positive
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 56 year old female patient with diabetes and hypertension. The patient had no drug reactions/allergies. On 20-AUG-2013, the patient was vaccinated with a single dose of ZOSTAVAX vial (lot # J002241, expiry date 21-MAY-2014) subcutaneous in the left arm. Concomitant therapies included GLUCOPHAGE. On 27-AUG-2013, the patient was diagnosed with shingles. The rash extended from the left external ear to the second branch of the left 5th nerve. The patient was prescribed VALTREX and KEFLEX. Approximately on an unknown date in August 2013, isolates from the lesions were positive for VZV (Varicella zoster virus) DNA. Approximately on an unknown date in 2013, the patient experienced hearing loss, bloody discharge and left ear pain. The patient sought medical attention (office visit). The patient was in the office on 10-SEP-2013, continued to have left ear pain, bloody discharge, and hearing loss. The outcome of hearing loss, bloody discharge, left ear pain and shingles was reported as not recovered. Upon internal review the event hearing loss was considered as medically significant. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Diarrhoea, Feeling abnormal, Feeling cold, Pain
Clinical narrative: Diarrhea, fever, cold chills, achy feeling for 3 days. Foggy head.
Age: 60.0
Sex: F
Vaccine: FLUX
Symptoms: Pyrexia
Clinical narrative: Diarrhea, fever, cold chills, achy feeling for 3 days. Foggy head.
Age: 30.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Erythema, Local swelling, Rash, Tenderness
Clinical narrative: Rash (non-indurated) slight erythematous swelling on the RUE, fairly round (6-7 cm) 2nd similar patch of erythema that is less round, more medial, tender.
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Flushing, Pruritus, Urticaria
Clinical narrative: Pt received his first PNEUMOVAX around 1030 AM on 9/17/13. By 1500 same day he broke out in hives all over (worst on trunk) and flushing of face with extreme itching. Took BENADRYL and CLARITIN.
Age: 12.0
Sex: F
Vaccine: HPV4, TDAP, VARCEL
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Neighbor brought child to HD for vaccines. Varicella vaccine given and then found another immunization record stating she had already had her 2nd Varicella. No adverse event reported.
Age: 54.0
Sex: F
Vaccine: FLU3, FLU4
Symptoms: Blister, Blister rupture, Hypersensitivity, Laboratory test, Pruritus
Clinical narrative: This non-medical confirmed spontaneous report (initial receipt 04-Sep-2013) concerns a 54-year-old female patient, with a history of Hepatitis C and allergy to Sulfa drugs, MIRAPEX and LYRICA. Concomitant medications included a host of unspecified medications. The patient had received flu shots in the past, without reaction, aside from mild sickness lasting one day after a single vaccination (see 2013038004). On 28-Aug-2013 (reported as '1 weeks ago on a Wednesday'), the patient was administered, in the right arm, AFLURIA (batch not reported) for routine vaccination at a 'standard dose/frequency'. On 30-Aug-2013 (reported as by 'the Friday of the same week'), the patient developed a severe allergic reaction, huge blisters on (my) back, neck and arm/large half-dollar sized blisters that were raised approximately 1-1.5 inches from the skin on the left arm and back described as severe in intensity. The majority of blisters were on the left side. At the time of the report, the patient was recovering. The majority of the blisters were gone but the 'area looked like a large abrasion with the remaining blisters popping on their own and that the liquid coming from the remaining blisters was yellow. It was also reported that the area started to develop an itchy sensation as if it was in the process of healing. The patient attended the Emergency Room for treatment and had seen a dermatologist, who stated that the reaction was related to the vaccine. The dermatologist drained the blisters and prescribed unspecified creams and antibiotics. It was reported that unspecified lab work has been conducted. Outcome was reported as recovering. Linked to case 2013038004.
Age: 54.0
Sex: F
Vaccine: FLU3, FLU4
Symptoms: Purulent discharge
Clinical narrative: This non-medical confirmed spontaneous report (initial receipt 04-Sep-2013) concerns a 54-year-old female patient, with a history of Hepatitis C and allergy to Sulfa drugs, MIRAPEX and LYRICA. Concomitant medications included a host of unspecified medications. The patient had received flu shots in the past, without reaction, aside from mild sickness lasting one day after a single vaccination (see 2013038004). On 28-Aug-2013 (reported as '1 weeks ago on a Wednesday'), the patient was administered, in the right arm, AFLURIA (batch not reported) for routine vaccination at a 'standard dose/frequency'. On 30-Aug-2013 (reported as by 'the Friday of the same week'), the patient developed a severe allergic reaction, huge blisters on (my) back, neck and arm/large half-dollar sized blisters that were raised approximately 1-1.5 inches from the skin on the left arm and back described as severe in intensity. The majority of blisters were on the left side. At the time of the report, the patient was recovering. The majority of the blisters were gone but the 'area looked like a large abrasion with the remaining blisters popping on their own and that the liquid coming from the remaining blisters was yellow. It was also reported that the area started to develop an itchy sensation as if it was in the process of healing. The patient attended the Emergency Room for treatment and had seen a dermatologist, who stated that the reaction was related to the vaccine. The dermatologist drained the blisters and prescribed unspecified creams and antibiotics. It was reported that unspecified lab work has been conducted. Outcome was reported as recovering. Linked to case 2013038004.
Age: 54.0
Sex: F
Vaccine: FLU3, FLU4
Symptoms: Blister, Hypersensitivity, Pain, Wound drainage, Wound secretion
Clinical narrative: This non-medical confirmed spontaneous report (initial receipt 04-Sep-2013) concerns a 54-year-old female patient, with a history of Hepatitis C and allergy to Sulfa drugs, MIRAPEX and LYRICA. Concomitant medications included a host of unspecified medications. The patient had received flu shots in the past, without reaction, aside from mild sickness lasting one day after a single vaccination (see 2013038004). On 28-Aug-2013 (reported as '1 weeks ago on a Wednesday'), the patient was administered, in the right arm, AFLURIA (batch not reported) for routine vaccination at a 'standard dose/frequency'. On 30-Aug-2013 (reported as by 'the Friday of the same week'), the patient developed a severe allergic reaction, huge blisters on (my) back, neck and arm/large half-dollar sized blisters that were raised approximately 1-1.5 inches from the skin on the left arm and back described as severe in intensity. The majority of blisters were on the left side. At the time of the report, the patient was recovering. The majority of the blisters were gone but the 'area looked like a large abrasion with the remaining blisters popping on their own and that the liquid coming from the remaining blisters was yellow. It was also reported that the area started to develop an itchy sensation as if it was in the process of healing. The patient attended the Emergency Room for treatment and had seen a dermatologist, who stated that the reaction was related to the vaccine. The dermatologist drained the blisters and prescribed unspecified creams and antibiotics. It was reported that unspecified lab work has been conducted. Outcome was reported as recovering. Linked to case 2013038004.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Injection site pruritus, Injection site urticaria, Local swelling, Urticaria
Clinical narrative: Pt received Afluria flu vaccine on 9/16/13 at 18:00. On 9/17/13 at about 16:00 started L shoulder itching. Note hive on L shoulder and hive red raised area on L side of neck x 3.
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Pruritus generalised, Rash erythematous
Clinical narrative: Started with a bright red rash and very severe itching which started with face and neck eventually going all the way to my toes over 10 days. I was told after getting flu shot by the county nurse that I would have problems with this vaccine due to it having a preservative in it. My local doctor was giving out at Expo in town.
Age: 12.0
Sex: M
Vaccine: HEPA, MMR, MNQ, TDAP, VARCEL
Symptoms: Incorrect dose administered
Clinical narrative: Child given MMR #2, varicella #2, hep A #2 Tdap, MENACTRA vaccine after checking immunizatoin record provided and this after vaccine given. Mother of child provided other vaccine rciivd showing child had vaccines previously .
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Irritability, Rash
Clinical narrative: Patient received varicella 2 weeks ago, the rash started 2 days ago. The rash came out in crops patient is cranky, no fever. Avoid babies for 1 week, continue Aveeno bath's, benadryl cream and oral benadryl as needed. 09/16/2013.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Drug administered to patient of inappropriate age, Herpes zoster
Clinical narrative: This spontaneous report was received from a pharmacist via company representative refers to an unknown age female patient. Pharmacist reported patient was administered three to five doses of ZOSTAVAX (lot# unspecified) (route, dose and location unspecified) for shingles prevention since an unspecified date with the last dose of ZOSTAVAX administered on 30-AUG-2012. The patient was diagnosed with three cases of shingles on unspecified dates after an unspecified number of doses of ZOSTAVAX were administered on unspecified date. Pharmacist also reported that patient was prescribed FOSAMAX (lot# unspecified) tablet orally once a week 70mg as reported since an unspecified date. Concomitant therapies included with XANAX, Atenolol, Fluoxetine, SYNTHROID, Prazosin, PRISTIQ, SEROQUEL, SIMVASTATIN TABLETS, USP and Trazodone Hydrochloride. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discolouration, Injection site rash
Clinical narrative: This spontaneous report as received from a registered pharmacist refers to a 64 year old female patient with Thimerosal allergy. On 05-Sep-2013 the patient was vaccinated with a dose of ZOSTAVAX (lot # J001698, Exp date 08-May-2014), subcutaneous, dose and frequency unspecified. Concomitant therapies included amoxicillin. In September 2013 the patient developed a rash at the injections site of the ZOSTAVAX vaccination. The rash was described as a bright pink, raised oval area at the injection site of the ZOSTVAX vaccination about 2 ¼ inches across, not blistered and not itchy. There was no lab diagnostics studies performed. Patient contacted pharmacist and their physician for medical attention. The outcome of the event was reported as recovering/resolving. The patient informed the reporter that they were to get a Computed Tomography (CT) scan on 06-SEP-2013, but the CT scan was canceled due to the rash. The patient informed the pharmacist that they went to their physician (name of physician unspecified) on 06-SEP-2013 after the CT scan was canceled. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. On 10-SEP-2013, the patient was vaccinated with an expired dose of VARIVAX (lot# G007412, expiry; 02-AUG-2013) 0.5 ml, subcutaneously. It was unclear if it was the patient's first dose. No adverse effects reported. Additional information has been requested.
Age: 16.0
Sex: M
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 16 year old male patient. On 20-AUG-2013 the patient was vaccinated with a dose of ZOSTAVAX (dose, route, lot# and expiration date not known). On 20-AUG-2013, the patient was accidently administered a dose of ZOSTAVAX as opposed to VARIVAX. This should have been the patient's second dose of VARIVAX in the series. The administration date of first dose of VARIVAX was unspecified. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Headache, Injection site rash, Oral pain, Toothache
Clinical narrative: This spontaneous report was received from a patient of unknown age and gender. On 04-SEP-2013 the patient was vaccinated with a dose of ZOSTAVAX (lot#, expiration date and route not reported). Approximately on an unknown date in September 2013, the patient experienced rash around the injection site, headaches and also mouth (reported as mouth) and teeth pain. The outcome of the event was unknown. Causality was not reported. Consumer did not want to provide any additional information. Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Adverse event
Clinical narrative: This spontaneous report as received from a consumer refers to her friend. The reporter reported that the patient had a terrible experience after being administered ZOSTAVAX. The outcome of had a terrible experience after being administered ZOSTAVAX was unknown. Additional information is not expected.
Age: 16.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Injection site swelling
Clinical narrative: Swelling at injection site.
Age: 69.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Asthenia, Dizziness, Headache, Hyperhidrosis, Nausea
Clinical narrative: Severe dizziness, sweating, nausea, weakness, (one hour) pain both arms, and headache lasted all night.
Age: 69.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Pain in extremity
Clinical narrative: Severe dizziness, sweating, nausea, weakness, (one hour) pain both arms, and headache lasted all night.
Age: 32.0
Sex: M
Vaccine: MEN
Symptoms: Pyrexia
Clinical narrative: Mild Fever; 100.5.
Age: 10.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Cataplexy, Fall, Food allergy, Loss of control of legs, Milk allergy
Clinical narrative: Patient had 2 Flu shots 8/17/09 and 9/02/2010, only flu shots she has ever had. Narcoleptic events started immediately in November 2010. Narcolepsy with cataplexy. Would wake from sleep not being able to move her limbs, excessive daytime sleeping, cataplexy as well when experiencing laughter (would fall to ground as her legs would give out) Food allergies found as well to egg, dairy, peanut, shellfish. Since the onset is believed to have been caused by the H1N1 flu vaccine, no medication is currently being taken to control the narcolepsy.
Age: 10.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Mobility decreased, Narcolepsy, Sleep study, Somnolence
Clinical narrative: Patient had 2 Flu shots 8/17/09 and 9/02/2010, only flu shots she has ever had. Narcoleptic events started immediately in November 2010. Narcolepsy with cataplexy. Would wake from sleep not being able to move her limbs, excessive daytime sleeping, cataplexy as well when experiencing laughter (would fall to ground as her legs would give out) Food allergies found as well to egg, dairy, peanut, shellfish. Since the onset is believed to have been caused by the H1N1 flu vaccine, no medication is currently being taken to control the narcolepsy.
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Blood pressure increased, Chills, Cough, Fatigue, Headache
Clinical narrative: Fever/chills, fatigue/cough/headache/stuffy nose, blood pressure 180/85, heart rate 100.
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Heart rate increased, Nasal congestion, Pyrexia
Clinical narrative: Fever/chills, fatigue/cough/headache/stuffy nose, blood pressure 180/85, heart rate 100.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Crying, Pain, Pain in extremity, Pyrexia
Clinical narrative: Mom states child came to her at 1:00 Am with fever and body aches. She was given Tylenol and continued to have fever and increased body/joint aches and was crying with pain. Complained that the tops of her feet hurt. She was taken to ER by 4:30 AM. She was monitored there for approximately 3.5 hrs and discharged home. She continued to have fever for the next 48 hrs.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Blood pressure decreased, Chills, Syncope, Tremor
Clinical narrative: Patient experienced chills/shakes 1 hour post vaccination. Syncope 4 hours later with continued decrease in blood pressure. Patient saw family doctor the following day and blood pressure medication was temporarily discontinued. Blood pressure meds were restarted several days later.  Upon post incident discussion with patient he mention that he had had shakes several hours after vaccination with regular flu shot last year but they only lasted 1/2 hour. This was not disclosed prior to this years vaccination.
Age: 26.0
Sex: F
Vaccine: PPV
Symptoms: Dyspnoea, Hyperhidrosis, Immediate post-injection reaction
Clinical narrative: EMPLOYEE BECAME DIAPHORETIC, SOB IMMEDIATELY.
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Discomfort, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: At the site of the injection (on her upper arm), the patient's arm was red, swollen, painful and very hot to the touch.  The red swollen area got bigger and bigger over the next few days, then it went away over a few days time.  It was very painful for her.  We tried ice to reduce swelling and pain but it was too uncomfortable for her.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Eye pruritus, Headache, Injection site erythema, Injection site reaction
Clinical narrative: Itchy, bloodshot eyes & redness around both eyes; muscle ache around vaccinated area as well as redness & slight swelling; low grade fever; headache; nausea.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Myalgia, Nausea, Ocular hyperaemia, Pyrexia, Vaccination site swelling
Clinical narrative: Itchy, bloodshot eyes & redness around both eyes; muscle ache around vaccinated area as well as redness & slight swelling; low grade fever; headache; nausea.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Cough, Oropharyngeal pain, Pain, Palpitations
Clinical narrative: STARTED 9/17/2013 AT APPROX 10 PM W/ SORE THROAT, SCRATCHY THROAT AND COUGH - THEN PROGRESSED TO CHILLS W/ SHAKING - ESPECIALLY LEGS, NO TEMPERATURE OBTAINED, HEART PALPITATIONS, BODY ACHES, THEN VOMITING - PT REPORTED FEELING MUCH BETTER AFTER VOMITING - SEVERITY OF OCCURRENCE SUBSIDED AFTER VOMITING AT APPROX 11:30 PM; PT REPORTS SLEEPING THROUGH NIGHT AND AWOKE FEELING "NORMAL" - OCCURRENCE RESOLVED.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Throat irritation, Tremor, Vomiting
Clinical narrative: STARTED 9/17/2013 AT APPROX 10 PM W/ SORE THROAT, SCRATCHY THROAT AND COUGH - THEN PROGRESSED TO CHILLS W/ SHAKING - ESPECIALLY LEGS, NO TEMPERATURE OBTAINED, HEART PALPITATIONS, BODY ACHES, THEN VOMITING - PT REPORTED FEELING MUCH BETTER AFTER VOMITING - SEVERITY OF OCCURRENCE SUBSIDED AFTER VOMITING AT APPROX 11:30 PM; PT REPORTS SLEEPING THROUGH NIGHT AND AWOKE FEELING "NORMAL" - OCCURRENCE RESOLVED.
Age: 27.0
Sex: M
Vaccine: FLU3
Symptoms: Blood pressure increased, Cheilitis, Dyspnoea, Heart rate increased, Pharyngeal erythema
Clinical narrative: By 3:30p his ears, throat and lips were red, facial swelling, BP 144/100, HR 110-115. Some shortness of breath. Symptoms resolved by 5:30p after 50mg PO Benadryl. Taken to ER by EMs at 6pm where no further treatment was required.
Age: 27.0
Sex: M
Vaccine: FLU3
Symptoms: Swelling face
Clinical narrative: By 3:30p his ears, throat and lips were red, facial swelling, BP 144/100, HR 110-115. Some shortness of breath. Symptoms resolved by 5:30p after 50mg PO Benadryl. Taken to ER by EMs at 6pm where no further treatment was required.
Age: 17.0
Sex: F
Vaccine: VARCEL
Symptoms: Asthenia, Expired drug administered, Injection site nodule
Clinical narrative: This spontaneous report as received from a consumer, the mother of the patient, who refers a 17 year old female patient with none drug reactions/allergies and no pertinent medical history. On 10-DEP-2013, the patient was vaccinated with an expired VARIVAX dose 0.5 ml / one shot, routed reported as "injection" and expiration date 02-AUG-2013 (concentration, lot and route were not reported) for "routine vaccination". None concomitants medications were reported. On 10-SEP-2013, the patient experienced an injection/site reaction as "a knot" on her arm and she also reported feeling weak. None lab diagnostics were performed. On unknown date the patient sought medical attention with an unspecified physician. The patient did not receive treatment for the event. At the time of the report the patient was recovering from feeling weak. Additional information has been requested.
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 unspecified number of patient of unknown age and gender. Approximately on an unknown date in September 2013, the patients may might have been vaccinated with a dose of MMR II (lot number, expiry date, route and dose were not reported) exposed to 55 Fahrenheit for as much time as 5 hours. No additional information was currently available at this time and there was no adverse experience to report. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Post herpetic neuralgia, Skin lesion
Clinical narrative: This spontaneous report as received from a medical assistant via a company representative refers to a female patient in her 70's. Medical history was not provided. On an unknown date, in the past year, the patient developed postherpetic neuralgia on the back of her head. The physician assistant examined the patient and identified a few lesions on the back of her head. The patient was treated with an unspecified antiviral medication. The outcome of postherpetic neuralgia, with a few lesions on the back of the head was reported as not recovered. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to a patient of unknown age. On an unknown date in June 2013, the patient was vaccinated with first dose of PROQUAD (lot number, expiry date and route was not reported). On 16-SEP-2013, the patient was vaccinated with M-M-R II (lot number, expiry date and route was not reported). No adverse symptoms were reported. Additional information has been requested.
Age: 39.0
Sex: F
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, Measles antibody negative, Wrong drug administered
Clinical narrative: This spontaneous report was received from a Medical Assistant concerning a 39 year old female patient. On an unknown date, the patient was vaccinated with a dose of PROQUAD (Merck) (dose, route, Lot # and expiration date not provided). No other co-suspect therapy was reported. Concomitant medications were not provided. The Medical Assistant called regarding the accidental administration of PROQUAD (Merck) to an unspecified 39 year old female patient on 30-AUG-2013. Patient had titers drawn on an unspecified date for measles, mumps and rubella. The measles titer results came back as equivocal on an unspecified date. It was unknown if the patient ever received the full series (2 doses) of MMR in the past. The patient should have been administered MMR. The outcome of the events was unknown. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4, HPV4, MEN
Symptoms: Muscle twitching
Clinical narrative: This spontaneous report as received from a physician refers to a 11 year old female girl. On 30-AUG-2012, the patient was vaccinated with the first dose in series of GARDASIL injection (lot number, dose, route and site of administration were not reported) and an unspecified number of other unspecified vaccines. The mother of the patient reported that the patient experienced facial twitching on an unspecified date after administration of GARDASIL. The patient did not seek medical attention. The facial  twitching resolved on an unspecified date. This case is linked with MARRS # 1309USA000782 (same reporter link). Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4, HPV4, MEN
Symptoms: Incomplete course of vaccination, Muscle twitching
Clinical narrative: This spontaneous report as received from a physician refers to a 11 year old female girl. On 30-AUG-2012, the patient was vaccinated with the first dose in series of GARDASIL injection (lot number, dose, route and site of administration were not reported) and an unspecified number of other unspecified vaccines. The mother of the patient reported that the patient experienced facial twitching on an unspecified date after administration of GARDASIL. The patient did not seek medical attention. The facial  twitching resolved on an unspecified date. This case is linked with MARRS # 1309USA000782 (same reporter link). Additional information has been requested.
Age: 76.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Local swelling, Swelling face
Clinical narrative: This spontaneous report as received from a pharmacist via company representative refers to a 76 year old female patient with no history of drug reactions or allergies. The patient's medical history included multiple cases of shingles accompanied by post herpetic neuralgia. On 28-AUG-2013 the patient was vaccinated with ZOSTAVAX injection (route, dose, lot number and expiration date not provided). On 31-AUG-2013 the patient experienced swollen face, swollen feet and swollen arm. The patient saw an unspecified physician and had been administered an unspecified steroid shot which helped with the swelling but did not completely alleviated it. The pharmacist believed that the patient might be having an allergic reaction to the neomycin component of the ZOSTAVAX. The outcome of the adverse event was reported as recovering/resolving. At the time of report the patient still had some swelling. The relatedness between vaccination with ZOSTAVAX and swollen face, swollen feet and swollen arm was not reported. Additional information has been requested.
Age: 76.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site swelling, Peripheral swelling, Rash erythematous
Clinical narrative: This spontaneous report as received from a pharmacist via company representative refers to a 76 year old female patient with no history of drug reactions or allergies. The patient's medical history included multiple cases of shingles accompanied by post herpetic neuralgia. On 28-AUG-2013 the patient was vaccinated with ZOSTAVAX injection (route, dose, lot number and expiration date not provided). On 31-AUG-2013 the patient experienced swollen face, swollen feet and swollen arm. The patient saw an unspecified physician and had been administered an unspecified steroid shot which helped with the swelling but did not completely alleviated it. The pharmacist believed that the patient might be having an allergic reaction to the neomycin component of the ZOSTAVAX. The outcome of the adverse event was reported as recovering/resolving. At the time of report the patient still had some swelling. The relatedness between vaccination with ZOSTAVAX and swollen face, swollen feet and swollen arm was not reported. Additional information has been requested.
Age: 13.0
Sex: M
Vaccine: HPV4
Symptoms: Muscle twitching
Clinical narrative: This spontaneous report as received from a physician refers to a 13 year old male boy. On 30-AUG-2012, the patient was vaccinated with the first dose in series of GARDASIL injection (lot number, dose, route and site of administration were not reported) and an unspecified number of other unspecified vaccines. The mother of the patient reported that the patient experienced facial twitching on an unspecified date after administration of GARDASIL. The patient did not seek medical attention. The facial twitching resolved on an unspecified date.  This case is linked with MARRS 1309USA007209 (same reporter link). Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Fatigue, Joint injury, Nausea, Pyrexia
Clinical narrative: This spontaneous report as received from a consumer (the patient's mother) refers to a 17 year old female, non-pregnant patient with an allergy to red cedar pollen. On 06-AUG-2013 the patient was vaccinated with the second dose of GARDASIL (route, lot number and expiration date were not reported). There were no concomitant medications or pertinent medical history. On 15-AUG-2013 (also reported as for the last eight days) the patient experienced extreme fatigue and intermittent fever reaching up to 101.8 F. On 23-AUG-2013 the patient experienced nausea, dizziness and in the morning has fainted on the bathroom floor subsequently hurting her left shoulder and knee. The patient had no recollection on how she made it to the bed, or when she called her parent for help. The patient's mother stated that her daughter was a completely active and healthy individual prior to the administration of the 2nd dose of GARDASIL. At the time of this report the patient did not recover from the reported adverse events. She sought the medical attention and contacted the physician's office. The relatedness between nausea, dizziness, fainted, hurting her left shoulder and knee, extreme fatigue, intermittent fever and the vaccination with GARDASIL was not reported. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: This spontaneous report as received from a consumer (the patient's mother) refers to a 17 year old female, non-pregnant patient with an allergy to red cedar pollen. On 06-AUG-2013 the patient was vaccinated with the second dose of GARDASIL (route, lot number and expiration date were not reported). There were no concomitant medications or pertinent medical history. On 15-AUG-2013 (also reported as for the last eight days) the patient experienced extreme fatigue and intermittent fever reaching up to 101.8 F. On 23-AUG-2013 the patient experienced nausea, dizziness and in the morning has fainted on the bathroom floor subsequently hurting her left shoulder and knee. The patient had no recollection on how she made it to the bed, or when she called her parent for help. The patient's mother stated that her daughter was a completely active and healthy individual prior to the administration of the 2nd dose of GARDASIL. At the time of this report the patient did not recover from the reported adverse events. She sought the medical attention and contacted the physician's office. The relatedness between nausea, dizziness, fainted, hurting her left shoulder and knee, extreme fatigue, intermittent fever and the vaccination with GARDASIL was not reported. Additional information has been requested.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Rash
Clinical narrative: Rash within 30 min, itching, treated with oral Benadryl and sent to E.D. per standing orders. BP 142/90. Spoke with Pt 9/18/13, no problems, no further treatment in E.D. 2010-2012 rcvd 3 doses Novartis Flu vaccine.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Paraesthesia, Paraesthesia oral
Clinical narrative: Pt c/o tingling in lips 15 minutes after immunization given. 1/2 hr later pt c/o tingling radiating towards cheek. Pt took 25 mg Benadryl PO at 11:30 AM. 12:05 PM symptoms have dissipated. To follow up with PMD.
Age: 5.0
Sex: M
Vaccine: FLUN4
Symptoms: Urticaria
Clinical narrative: Patient developed welps 72hrs after vaccination w/ FLUMIST. Dr at Urgent Care believed it was due to FLUMIST. Treated with Prednisone 5mg/5ml 1 tsp. QID x 3 days. Spoke with mom today and patient is "perfectly fine".
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Eye pain, Eyelid pain, Herpes zoster, Nausea, Pain of skin
Clinical narrative: This spontaneous report was received from a 64 year old female patient reporting on herself.  The patient's medical history included nausea (also reported as no pertinent medical history). Historical drug included codeine. On 19-AUG-2013, the patient was vaccinated with dose of ZOSTAVAX 0.65 ml/single dose (lot # J001005, expiration date 24-APR-2014). No other co-suspect therapy was reported. There were no concomitant medication. About eight days after receiving ZOSTAVAX, approximately on 27-AUG-2013, the patient developed sensitivity and pain in her scalp and around her eye which she believed to be caused by shingles. She added that she also had some bumps on her eyelid that were painful. The patient also stated that codeine (unspecified manufacturer, strength and frequency) made her nauseated. No treatment was given for the events. No lab diagnostics studies were performed. The outcome of the events was reported as not recovered/not resolved. The outcome of nauseated was unknown. The patient did not seek medical attention. Additional information has been requested.