chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Full blood count normal, Nausea, Thyroid function test normal, Vertigo
Clinical narrative: Received #2 dose of HPV4 (Gardasil) and approximately 10 minutes after receiving the vaccine she started feeling dizzy.  She was seen in the office 8-2-11 with persistant dizziness and complaints of fatigue.  No vomiting, but is nauseated.  She feels like her "world is spinning."  No changes with position, the dizziness is constant.  Has been afebrile. These symptoms have persisted since vaccination.  LMP:  7-18-2011.  Orthostatic BP at 8-2-11 office visit:  Supine  134/80; sitting  124/77; standing  119/79.  Was prescribed Meclizine 25mg, 1-2 tabs BID-TID prn dizziness.  CBC W/ diff, CMP, Thyroid screen, CAT scan of brain all WNL. BMI:  39.68.  Birth control: Depo Provera.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Pyrexia
Clinical narrative: Reported that child had some redness on L arm, fever.
Age: 22.0
Sex: F
Vaccine: ANTH, SMALL, TYP
Symptoms: Pruritus generalised, Rash, Urticaria
Clinical narrative: Pt called PRP office requesting to see her primary care provider.  Stated she awakened this am with hives and a rash on her arms, chest and legs.  Denied dyspnea, cough, dysphagia, or edema.  Pt referred to MD for evaluation ASAP.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Immediate post-injection reaction, Injection site pain, Injection site swelling, Mobility decreased, Pain
Clinical narrative: Initial pain and swelling at site immediately after injection, however those symptoms did improve. Approximately 4 days after injection the swelling got worse, pain increased with difficulty moving arm.
Age: 51.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injection site oedema, Injection site pain, Malaise, Pyrexia
Clinical narrative: malaise, fever
Age: 51.0
Sex: F
Vaccine: PPV
Symptoms: White blood cell count increased
Clinical narrative: malaise, fever
Age: 14.0
Sex: M
Vaccine: HEPA
Symptoms: Pyrexia
Clinical narrative: High Fever
Age: 63.0
Sex: F
Vaccine: FLUX, TDAP, VARCEL
Symptoms: Chills, Cough, Fatigue, Malaise, Oedema peripheral
Clinical narrative: Extreme Kidney Pain, Tremors or shaking of the body, violent cough, fever, chills, feeling exhausted, very tired, swollen of feet.
Age: 63.0
Sex: F
Vaccine: FLUX, TDAP, VARCEL
Symptoms: Pyrexia, Renal pain, Tremor
Clinical narrative: Extreme Kidney Pain, Tremors or shaking of the body, violent cough, fever, chills, feeling exhausted, very tired, swollen of feet.
Age: 21.0
Sex: M
Vaccine: HEPA, TDAP
Symptoms: Antineutrophil cytoplasmic antibody negative, Complement factor C3 decreased, Leukocytoclastic vasculitis, Skin disorder, Skin lesion
Clinical narrative: On 01 Apr 08 he was vaccinated with Hep A # 2, and TdaP. He denied any immediate problems with vaccination. Approx a couple of weeks later he started to develop lesions on his body and was diagnosed by a  dermatologist as having leukocytoclastic vasculitis. Records of this visit are not available. Since that time he has had recurrent lesions with subsequent evaluations by allergy, dermatology, and rheumatology. His current diagnosis is chronic, cutaneous, ANCA negative, small vessel vasculitis associated with mildly low C3 level, without signs of systemic involvement. Other that an influenza vaccine in Oct 08, without worsening of symptoms, he was received no other immunizations.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Erythema, Headache, Injection site erythema, Injection site rash
Clinical narrative: Within 12 hours of receiving GARDASIL # 1 pt. describes : headache, lightheaded, lasting for 24 hrs. Swollen lymph nodes both sides for 3 days. Fever of 101.5 for 5 days. Both arms from shoulders to elbows a rash "pores were red and open". Rash lasted 24 hrs. No urticaria. No other s/sx described.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Lymphadenopathy, Pyrexia, Rash
Clinical narrative: Within 12 hours of receiving GARDASIL # 1 pt. describes : headache, lightheaded, lasting for 24 hrs. Swollen lymph nodes both sides for 3 days. Fever of 101.5 for 5 days. Both arms from shoulders to elbows a rash "pores were red and open". Rash lasted 24 hrs. No urticaria. No other s/sx described.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Convulsion, Pyrexia, White blood cell count increased
Clinical narrative: Seizure lasting about 15 minute seen in Emergency department. Fever T 101.9 rectally TYLENOL given. ATIVAN given I.M.
Age: 54.0
Sex: U
Vaccine: PNC13
Symptoms: Erythema, Oedema peripheral, Pain in extremity, Skin warm
Clinical narrative: Swelling, redness & warmth to touch on right arm. Mild pain, no SOB.
Age: 15.0
Sex: F
Vaccine: TDAP
Symptoms: Abdominal discomfort, Pallor
Clinical narrative: Extreme upset stomach, looked very pale. Paramedic came to take care of her brother who was having reaction to ADACEL. She was checked out by paramedic too. Pt felt "fine" afterwards and went home with mom.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Computerised tomogram, Gaze palsy, Head injury, Headache, Loss of consciousness
Clinical narrative: Pt received an injection of HPV, about 5 min after injection, patient stood, passed out, hit head on cabinet before hitting the floor. LOC for about 2-3 min. Pt had some generalized tremors, eyes rolled, pt was slow to respond (> 5min) c/o HA transported to Hosp via ambulance.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Slow response to stimuli, Tremor
Clinical narrative: Pt received an injection of HPV, about 5 min after injection, patient stood, passed out, hit head on cabinet before hitting the floor. LOC for about 2-3 min. Pt had some generalized tremors, eyes rolled, pt was slow to respond (> 5min) c/o HA transported to Hosp via ambulance.
Age: 18.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site mass, Pain, Tenderness
Clinical narrative: 1 min. after injection Tdap into right deltoid patients muscle developed a lump size of a nickel. Advise patient to take TYLENOL or BENADRYL after arriving home today. Patient stated she felt sorness/tenderness but other than that she was ok to drive herself home.
Age: 29.0
Sex: M
Vaccine: FLU3
Symptoms: Anti-SS-A antibody positive, Anti-SS-B antibody positive, Antinuclear antibody positive, Chest X-ray normal, Computerised tomogram normal
Clinical narrative: None stated.
Age: 29.0
Sex: M
Vaccine: FLU3
Symptoms: Drug screen negative, Lumbar puncture normal, Metabolic function test, Metabolic function test normal, Nuclear magnetic resonance imaging normal
Clinical narrative: None stated.
Age: 29.0
Sex: M
Vaccine: FLU3
Symptoms: Red blood cell sedimentation rate increased, Toxicologic test normal, Unevaluable event, White blood cell count
Clinical narrative: None stated.
Age: 0.5
Sex: M
Vaccine: TDAP
Symptoms: Pruritus, Rash
Clinical narrative: Began itching 08-1-11 about 2 hrs after vaccine and broke out in rash. Patient came into clinic on 08-2-11 was given Rx for BENADRYL 12.5mg/5ml one PO every 6 hrs PRN.
Age: 18.0
Sex: M
Vaccine: TDAP
Symptoms: Feeling abnormal, Loss of consciousness, Unresponsive to stimuli, Vomiting
Clinical narrative: Pt passed out in chair (head down) shortly after shot. Didn't respond when mom & I asked if he was ok. Then regained consciousness, I called 911 - then he passed out & regained conscious again. Laid pt down on floor. Took BP. Paramedic arrived about 5-10 min monitored. Pt threw up. Pt was transported to hospital b/c pt said he felt it was going to happen again.
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Burning sensation, Infection, Injection site swelling, Mobility decreased, Pruritus
Clinical narrative: States had no problem when vaccine given, about hours later site to injection started swelling. States that every day swelling was increasing difficulty icing it. About 3 days later could not move again. Thinks had fever 7-30-11 - did not check temp. Today 8/3/11 still itching/burning sensation. Went to see MD today 8/3/11 told had infection, given antibiotics will return with MD on 8/5/11.
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia
Clinical narrative: States had no problem when vaccine given, about hours later site to injection started swelling. States that every day swelling was increasing difficulty icing it. About 3 days later could not move again. Thinks had fever 7-30-11 - did not check temp. Today 8/3/11 still itching/burning sensation. Went to see MD today 8/3/11 told had infection, given antibiotics will return with MD on 8/5/11.
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Rash erythematous, Swelling
Clinical narrative: Red erythematous rash with swelling.
Age: 51.0
Sex: F
Vaccine: HEPAB, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Swollen, erythema, hot, pain in site.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Redness, swelling, pain, warmth of (L) arm at site of injection - of ZOSTAVAX.
Age: 0.78
Sex: F
Vaccine: DTAPHEPBIP, PNC
Symptoms: Electroencephalogram, Injection site erythema, Staring
Clinical narrative: Two (2) staring spells: (1) 8/2/11 at 5:20 pm (2) 8/3/11 at 11:30 am. 9 1/2 cm x 6 cm area of erythema at site.
Age: 23.0
Sex: M
Vaccine: ANTH, HEPAB, TYP
Symptoms: Presyncope
Clinical narrative: Vasovagal. Patient placed supine on exam table. Orthostatic vital signs. Released by Capt.
Age: 10.0
Sex: M
Vaccine: TDAP, VARCEL
Symptoms: Abdominal pain, Computerised tomogram head, Computerised tomogram normal, Dyspnoea, Hyperventilation
Clinical narrative: Pt got Tdap on 7-26-11 and on 7-28-11 he started with pain on the (R) side of abdomen & felt numbness of whole body - shaky -hyperventilating with "difficulty breathing" lasting for few minutes - went to ER - CT scan done head - normal.
Age: 10.0
Sex: M
Vaccine: TDAP, VARCEL
Symptoms: Hypoaesthesia, Nervousness
Clinical narrative: Pt got Tdap on 7-26-11 and on 7-28-11 he started with pain on the (R) side of abdomen & felt numbness of whole body - shaky -hyperventilating with "difficulty breathing" lasting for few minutes - went to ER - CT scan done head - normal.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site pruritus, Vaccination site pain, Vaccination site swelling
Clinical narrative: Rt arm pain and itching on vaccination sites, also redness and swelling getting progressively worse. Appeared about 5-6 hours after received vaccine cold compresses, BENADRYL.
Age: 18.0
Sex: F
Vaccine: VARCEL
Symptoms: Abdominal discomfort, Erythema, Headache, Local swelling, Pain
Clinical narrative: 7/27/11 - 1/2 dollar size red area, swollen, heat, painful to touch. Itches, pts mom stated pt had not taken any medication. Pt came to HD, advised to take 600mg Ibuprofen and if not better by Friday to come back. 7/28/11 phone call from pts mom stating area spread and pt had HA and ill to stomach. Pt came to clinic and seen by MD who advised to go to ER. 8/2/11 I called pt, she did not go to ER but stated she is fine and it went away on 7/30/11.
Age: 18.0
Sex: F
Vaccine: VARCEL
Symptoms: Pruritus, Skin warm
Clinical narrative: 7/27/11 - 1/2 dollar size red area, swollen, heat, painful to touch. Itches, pts mom stated pt had not taken any medication. Pt came to HD, advised to take 600mg Ibuprofen and if not better by Friday to come back. 7/28/11 phone call from pts mom stating area spread and pt had HA and ill to stomach. Pt came to clinic and seen by MD who advised to go to ER. 8/2/11 I called pt, she did not go to ER but stated she is fine and it went away on 7/30/11.
Age: 3.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Vaccine admin 8-1-11; presented to office 8-3-11 with red, warm, swollen 3x5cm circumferential area involving (L) deltoid.
Age: 65.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Confusional state, Demyelination, Echocardiogram, Erythema, Lumbar puncture
Clinical narrative: Less than 48 hours after vaccine, went to ER with confusion, (R) arm pain & unable to move hand. Patient was transferred from one hospital ER, to another hospital ER developed lower extremity weakness. MD was felt to be suggestive of demyelinating disease. Received LEVAQUIN and acyclovir for (R) arm erythema. Started on IV SOLUMEDROL on 7/29. Pt discharged & f/u with PCP, neurologist, occupational/physical therapy.
Age: 65.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Mobility decreased, Muscular weakness, Nuclear magnetic resonance imaging, Pain in extremity
Clinical narrative: Less than 48 hours after vaccine, went to ER with confusion, (R) arm pain & unable to move hand. Patient was transferred from one hospital ER, to another hospital ER developed lower extremity weakness. MD was felt to be suggestive of demyelinating disease. Received LEVAQUIN and acyclovir for (R) arm erythema. Started on IV SOLUMEDROL on 7/29. Pt discharged & f/u with PCP, neurologist, occupational/physical therapy.
Age: 38.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Uterine dilation and curettage
Clinical narrative: Case number PHHY2011US65540 is a combined initial and follow up spontaneous report received from a consumer and a physician via another pharmaceutical company (ref: 7068842) on 19 Jul 2011. This case refers to a 39 year old female patient. Her medical history included miscarriage (9 weeks of gestation), type-2 diabetes mellitus (diagnosed in May 2006), and multiple sclerosis (diagnosed in Jan 2006). Concomitant medications included metformin and insulin. She was also receiving REBIF 22 microgram three times per week subcutaneously from 19 Jul 2006. She stopped treatment with REBIF in Aug 2009 when she learned that she was one month pregnant. She was vaccinated with H1N1 influenza vaccine (manufacturer and batch number unknown) on an unspecified date in Nov 2009. At 4 and half months of gestation (2 weeks after vaccination), she was diagnosed with miscarriage and was hospitalized. Heartbeat of the foetus was not detectable. A dilatation and curettage was performed. The outcome was not reported. The causality was not assessed. However, both H1N1 vaccine and REBIF were reported as suspect medications.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Musculoskeletal pain
Clinical narrative: Information has been received from a 68 year old male consumer with high cholesterol and no drug reactions/allergies, who on 07-MAR-2011 was vaccinated with a dose of ZOSTAVAX (Merck). (Lot numbers not reported). Concomitant therapy included simvastatin (manufacturer unknown) and CRESTOR. The patient reported that he experienced moderate to severe left shoulder pain after given the ZOSTAVAX (Merck) vaccine. No lab diagnostics studies were performed. At the time of the report, patient had not recovered. The patient did not seek medical attention. Additional information has been requested.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Rash macular, Rash papular, Rash pruritic, Rash vesicular
Clinical narrative: Information has been received from a nurse practitioner concerning a 67 year old male with hypertension and sulfonamide allergy who on 25-FEB-2011 was vaccinated with a dose of ZOSTAVAX (Merck) in his left arm at another facility. Concomitant therapy included lisinopril (manufacturer unknown), atenolol (manufacturer unknown) and aspirin. On 04-MAR-2011 the patient came to the nurse practitioner's office with a red, raised, cluster rash on his right hip, which was vesicular, macular and papular. The nurse practitioner reported that the patient reported that the rash was moderately painful, and itchy. The nurse practitioner reported that the patient was in no distress and the patient was afebrile. There was no treatment given to the event. There were no diagnostics studies performed. At the time of the report, the patient was recovering. Follow up information has been received from a nurse concerning the patient who on 13-MAR-2011 14:44, was experienced red raised vesicular rash 1"X2" on the right hip. At the time of the report, the patient had recovered. No further information was available.
Sex: F
Vaccine: VARZOS
Symptoms: Hot flush, Hyperhidrosis
Clinical narrative: Information has been received from a pharmacist concerning a female patient who on an unknown date was vaccinated with ZOSTAVAX (Merck) (dose, route and lot # not reported). The pharmacist reported that on an unspecified date the patient who received ZOSTAVAX (Merck) was experiencing hot flashes and sweating. It was unspecified that if the patient sought medical attention. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a 61 year old female nurse who on 28-JUL-2010 was vaccinated with a dose of ZOSTAVAX (Merck) (Lot # 664630/0837Y). On approximately 08-SEP-2010 (6 weeks after receiving the vaccination, also reported as 28-JUL-2010), the patient contracted a case of shingles. This was treated with antivirals (dose, frequency, manufacturer, and name of drugs were not specified). On 21-FEB-2011, it was reported that she again, contracted a case of shingles which was also treated with the same course of antivirals (dose, frequency, manufacturer, and name of drugs were not specified). The patient sought unspecified medical attention. At the time of this report, the outcome of the patient was not reported. Follow-up information was received from the nurse indicating that she had her vaccine through a public health clinic not at a doctor's office. No further information is available.
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Fungal infection
Clinical narrative: Information has been received from a consumer reporting herself with sulfa drugs allergy and allergic reaction to neomycin who "several days ago", was vaccinated with a first dose of ZOSTAVAX (Merck). The patient had been miserable ever since. She had a severe yeast infection all over her body. No treatment was given for the adverse events. At the time of reporting, the patient had not recovered. The patient sought unspecified medical attention. No further information is available.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site mass, Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: Information has been received from a 70 year old female consumer reporting herself with controlled hypertension and no drug reactions or allergies, who on 08-MAR-2011 was vaccinated with a dose of ZOSTAVAX (Merck) into her left arm (Dose, route of administration and lot number not provided) Concomitant therapy included an unspecified blood pressure and heart medications. On 09-MAR-2011 the patient reported that she had a "goose egg lump" around the injection site on her left arm. She also mentioned that she had a slight red rash at the injection site that was itchy for three days post vaccination along with slight swelling. Consumer stated "it reminded me a bee sting". The patient saw her pharmacist who recommended TYLENOL but she had not had taken the medication. As of 14-MAR-2011, the patient stated "it is getting better". At the time of the report the patient had not recovered. No laboratory diagnostics studies were performed. No further information is available.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Information has been received from an "over sixty year old" female consumer with a history of allergy to pet dander, who on 10-JUN-2008 received a single 0.65 ml dose of ZOSTAVAX (Merck) subcutaneously for the prevention of herpes zoster (lot # 659324/1835U). The patient reported that "about two and a half years ago" she experienced shingles on the side of her face after being administered ZOSTAVAX (Merck) on 10-JUN-2008 and that the rash spread into her left ear and left eye. The patient said she got the injection because her physician had "told her to do so". The physician did not perform a titer test on the patient to see if she had a history of chickenpox. The patient "regrets getting the vaccination and got it out of fear of getting shingles". The patient sought medical attention (not specified) and at the time of reporting did not yet recover. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a registered nurse concerning a 65 year old female patient with no drug reactions or allergies, who on 06-JUL-2009 was vaccinated with a 0.65 ml dose of ZOSTAVAX (Merck) (Lot # 664092/01998Y) SQ. The nurse reported that in February 2011, the patient developed shingles. There were no Lab diagnosis/studies performed. It was reported that oral antivirals and an unspecified ointment were given as treatment for the adverse event. The patient sought unspecified medical attention. At the time of the report, the patient had not recovered. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a female consumer reporting n herself, who on an unspecified date was vaccinated with a dose of ZOSTAVAX (Merck) (Lot # not reported) (dose and route not reported). The patient stated that subsequently from the time she received the ZOSTAVAX (Merck), she had several outbreak of shingles (18 times). It was unknown if the patient sought medical attention. At the time of the report, the patient's outcome was unknown. No further information is available.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Blood cholesterol, Ear pain, Injection site pain, Musculoskeletal pain
Clinical narrative: Information has been received from a medical assistant concerning a 66 year old male patient with a medical history of "vessel bypass" who on 28-FEB-2011 was vaccinated with ZOSTAVAX (Merck) (lot # 669405/1416Z, expiration date 21-JAN-2012). On 09-MAR-2011, the patient experienced neck, shoulder and ear pain after vaccination with ZOSTAVAX (Merck). The patient called the office reporting those events. The patient had a cough when vaccinated. No labs/diagnostics studies were performed. The patient's neck, shoulder and ear pain persisted. The patient was not given treatment for the event. The patient would be seen in the office on 16-MAR-2011. Follow-up information has been received from the medical assistant concerning the 66 year old male patient with chronic obstructive pulmonary disease (COPD) and a history of heart problems (stent inserted in 2006), who on 28-FEB-2011 was vaccinated with ZOSTAVAX (Merck) (lot # 669405/1416Z, expiration date 21-JAN-2012). On 09-MAR-2011, the patient complained of pain in his left arm, where ZOSTAVAX (Merck) was administered, as well as pain in his left ear. The patient then presented to the office on 16-MAR-2011 for an unrelated reason and noted that he still had the pain but it was improving. Follow up information was received from a physician concerning a 66 year old male ex-smoker (quit 1994) with dyslipidemia, diabetes mellitus type 2, chronic obstructive pulmonary disease, coronary artery disease, family history of cardiovascular disorder, family history of cancer and a family history of diabetes and a history of coronary artery bypass graft 4 vessel (JULY 2010), coronary stents x 3 (2006), appendectomy, MVA with wired jaw and tracheostomy, right ankle repair and right lower quadrant abscess with incision and drainage (FEBRUARY 2010) who on 28-FEB-2011 was given a dose of ZOSTAVAX (MERCK) (lot 669405/1416Z) subcutaneously in left arm. Concomitant medications included aspirin; fish oil; LIPITOR; losartan (manufacturer unknown), metformin (manufacturer unknown), metoprolol succinate extended release tablets; NITROQUICK; RANEXA; and TYLENOL ARTHRITIS. The patient had no know drug allergies. On 16-MAR-2011 the patient presented to his physician's office to follow up on pain in the left trapezius muscle area soon after getting a dose of ZOSTAVAX (MERCK). The patient was positive for joint pain. The patient was diagnosed with cervicalgia. The patient reported that his pain had been improving. It was unknown whether the patient had recovered from left ear pain, injection site pain or shoulder pain. It is unknown whether the patient received treatment or had any tests performed. The doctor reported he reassured the patient that cervicalgia was not due to the shingles vaccine. It was noted during the physical exam that the patient had a right lower quadrant incision with opening and packing. There was no drainage noted and the erythema had resolved. Additional information has been requested. All available medical records will be provided upon request.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Neck pain, Open wound, Prostatic specific antigen
Clinical narrative: Information has been received from a medical assistant concerning a 66 year old male patient with a medical history of "vessel bypass" who on 28-FEB-2011 was vaccinated with ZOSTAVAX (Merck) (lot # 669405/1416Z, expiration date 21-JAN-2012). On 09-MAR-2011, the patient experienced neck, shoulder and ear pain after vaccination with ZOSTAVAX (Merck). The patient called the office reporting those events. The patient had a cough when vaccinated. No labs/diagnostics studies were performed. The patient's neck, shoulder and ear pain persisted. The patient was not given treatment for the event. The patient would be seen in the office on 16-MAR-2011. Follow-up information has been received from the medical assistant concerning the 66 year old male patient with chronic obstructive pulmonary disease (COPD) and a history of heart problems (stent inserted in 2006), who on 28-FEB-2011 was vaccinated with ZOSTAVAX (Merck) (lot # 669405/1416Z, expiration date 21-JAN-2012). On 09-MAR-2011, the patient complained of pain in his left arm, where ZOSTAVAX (Merck) was administered, as well as pain in his left ear. The patient then presented to the office on 16-MAR-2011 for an unrelated reason and noted that he still had the pain but it was improving. Follow up information was received from a physician concerning a 66 year old male ex-smoker (quit 1994) with dyslipidemia, diabetes mellitus type 2, chronic obstructive pulmonary disease, coronary artery disease, family history of cardiovascular disorder, family history of cancer and a family history of diabetes and a history of coronary artery bypass graft 4 vessel (JULY 2010), coronary stents x 3 (2006), appendectomy, MVA with wired jaw and tracheostomy, right ankle repair and right lower quadrant abscess with incision and drainage (FEBRUARY 2010) who on 28-FEB-2011 was given a dose of ZOSTAVAX (MERCK) (lot 669405/1416Z) subcutaneously in left arm. Concomitant medications included aspirin; fish oil; LIPITOR; losartan (manufacturer unknown), metformin (manufacturer unknown), metoprolol succinate extended release tablets; NITROQUICK; RANEXA; and TYLENOL ARTHRITIS. The patient had no know drug allergies. On 16-MAR-2011 the patient presented to his physician's office to follow up on pain in the left trapezius muscle area soon after getting a dose of ZOSTAVAX (MERCK). The patient was positive for joint pain. The patient was diagnosed with cervicalgia. The patient reported that his pain had been improving. It was unknown whether the patient had recovered from left ear pain, injection site pain or shoulder pain. It is unknown whether the patient received treatment or had any tests performed. The doctor reported he reassured the patient that cervicalgia was not due to the shingles vaccine. It was noted during the physical exam that the patient had a right lower quadrant incision with opening and packing. There was no drainage noted and the erythema had resolved. Additional information has been requested. All available medical records will be provided upon request.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Application site erythema, Application site pain, Herpes zoster, Immediate post-injection reaction, Neuralgia
Clinical narrative: Information has been received from a 79 year old female patient with rapid heart beat, cholesterol and diabetes and no drug allergies or reactions, who on 26-JAN-2011 was vaccinated with a dose of ZOSTAVAX (Merck) (dose, route and lot # not specified). Concomitant therapy included Atenolol, ATIVAN, TYLENOL WITH CODEINE #3, simvastatin (manufacturer unknown), glipizide and aspirin. The patient reported that "the next day" (on 27-JAN-2011), she had the break out of shingles. The patient said she did not remember the medication given to her by her health care professional. Information received on 16-MAR-2011 contained the following adverse experiences: the patient was prescribed with capsaicin for the nerve pain from shingles and shingles rash and immediately (also reported as "last week" (on approximately 07-MAR-2011)), she started to feel a burning and redness where the cream was applied; the patient stated "she washed it off and had not reintroduced the cream". At the time of the report patient's outcome was not reported. The patient sought medical attention. Additional information is not expected.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Information has been received from a 66 year old female consumer with blood pressure, cholesterol and betacarotene allergy who on 10-MAR-2011 was vaccinated with a dose of ZOSTAVAX (Merck, Lot # and expiration date not reported). Concomitant therapy included lisinopril (manufacturer unspecified) and CRESTOR. Consumer reported that on 13-MAR-2011, she started experiencing fever. She mentioned that she also noticed that at the injection site it was warm and swollen and it was red with a rash. Patient sought medical attention by pharmacist.. No labs were performed. At the time of reporting patient's outcome was unknown. Follow up information been received from a medical assistant who stated that her office did not administer the injection to the patient, nor was patient seen by physician after the reported incident. She stated that physician's office had no information to offer regarding this adverse event. No further information is available.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site vesicles, Pain
Clinical narrative: Information has been received from a 60 year old female patient with sulfonamide allergy and no pertinent medical history, who on 15-MAR-2011 was vaccinated with a dose of ZOSTAVAX (Merck) (lot number not reported). Concomitant therapy included SYNTHROID and estrogens cream (unspecified). On 16-MAR-2011 the patient experienced few blisters at the injection site. The patient did not seek medical attention or underwent any diagnositc tests. At the time of the report the patient status was unknown. Follow up information has been received from a registered nurse, concerning herself, a female patient, with no illness at time of vaccination and no adverse events following prior vaccinations, who on 15-MAR-2011, in the morning, was vaccinated SQ into the left arm with the first dose of ZOSTAVAX (Merck) (lot number "1348Z" is an invalid lot number for ZOSTAVAX (Merck)). The nurse indicated that other concomitant therapy also included CYTOMEL and PREVACID. The nurse reported that on 17-MAR-2011 (previously reported as 16-MAR-2011) she woke up with blisters at the site of injection and later in the day, another blister next to it. The nurse also reported that the arm was stinging. The nurse said that 2 vesicles developed and lasted about 4 days. On 21-MAR-2011 the patient recovered. Additional information is not expected.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Swelling
Clinical narrative: Information has been received from a female consumer with no pertinent medical history and no drug reactions or allergies who on unspecified date was vaccinated with a dose of ZOSTAVAX (Merck) (dose, route and Lot # not reported). Concomitant therapy included vitamins (unspecified) and omeprazole. On unspecified date the patient experienced redness, puffiness and soreness at the site of her injection. The patient didn't seek medical attention and no lab diagnostics studies were performed. At the time of the report, the status of the patient was not reported. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Herpes zoster, Joint swelling, Pain in extremity
Clinical narrative: Information has been received from a Licensed Practical Nurse, concerning a 60 year old female patient with coronary artery disease, hypertension, hyperthyroidism, allergy to CIPRO, codeine, DEMEROL, MACROBID, and Sulfa (unspecified), who on 14-APR-2011 was vaccinated with a dose of ZOSTAVAX (Merck) (Lot #: 6695331/1383Z, Exp: May-2012) (dose and route not reported). Licensed practical nurse reported that on 15-APR-2011, the day after vaccination with ZOSTAVAX (Merck), patient developed swollen joints, chills, painful arms and hands and shingles on her left arm. Prednisone and VALTREX were given as treatment for the events. No lab/diagnostic studies were performed. At the time of the report, the patient's outcome was unknown. Patient sought medical attention through office visit. Additional information has been requested.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Bone pain, Chills, Feeling of body temperature change, Influenza, Influenza like illness
Clinical narrative: Information has been received from a registered nurse and a 64 year old male consumer, reporting on himself, with no pertinent medical history, drug reactions or allergies reported, who on 19-APR-2011 was vaccinated with a dose of ZOSTAVAX (Merck) (Lot #, dose and route not reported). Concomitant therapy included allopurinol. Consumer reported that on 20-APR-2011 he experienced swelling and a rash at the injection site which went away. He reported that on approximately 22-APR-2011, a couple of days later, a bug or flu developed where he felt nauseous and his bones hurt. Registered nurse confirmed that on 19-APR-2011, patient was vaccinated with ZOSTAVAX (Merck) (lot #, dose and route not reported). She reported that on 22-APR-2011, three days later, patient called the doctor's office to report he experienced flu-like symptoms: nauseous, bone aches, chills, feeling hot and cold. Nurse stated consumer never said he had a rash. No treatment was given for the events. No lab/diagnostic studies were performed. On an unspecified date, patient recovered. Additional information has been requested.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site rash, Injection site swelling, Nausea
Clinical narrative: Information has been received from a registered nurse and a 64 year old male consumer, reporting on himself, with no pertinent medical history, drug reactions or allergies reported, who on 19-APR-2011 was vaccinated with a dose of ZOSTAVAX (Merck) (Lot #, dose and route not reported). Concomitant therapy included allopurinol. Consumer reported that on 20-APR-2011 he experienced swelling and a rash at the injection site which went away. He reported that on approximately 22-APR-2011, a couple of days later, a bug or flu developed where he felt nauseous and his bones hurt. Registered nurse confirmed that on 19-APR-2011, patient was vaccinated with ZOSTAVAX (Merck) (lot #, dose and route not reported). She reported that on 22-APR-2011, three days later, patient called the doctor's office to report he experienced flu-like symptoms: nauseous, bone aches, chills, feeling hot and cold. Nurse stated consumer never said he had a rash. No treatment was given for the events. No lab/diagnostic studies were performed. On an unspecified date, patient recovered. Additional information has been requested.
Age: 1.3
Sex: M
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a certified medical assistant concerning a 15 month old male patient who on 30-NOV-2009, was vaccinated with a dose of ZOSTAVAX (Merck) instead of VARIVAX (Merck) (route and lot number not reported). The medical assistant reported no adverse effect. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes simplex, Injection site erythema, Injection site swelling, Oral herpes
Clinical narrative: Information has been received from a doctor of dental science concerning a patient who on 26-APR-2011 was vaccinated with a dose of ZOSTAVAX (Merck) (therapy route and lot # not provided). The patient developed a 4 cm red and swollen area at site of injection after administration of ZOSTAVAX (Merck). The patient also developed oral herpes simplex 1. Patient sought medical attention via office visit. At the time of reporting, the patient was recovering. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Information has been received from a female who on 31-MAR-2011 was vaccinated with a dose of ZOSTAVAX (Merck) (therapy route and lot # not provided) in the arm for prevention of shingles. After getting the vaccine, the injection site was red and hot for two to three weeks. But the patient had not experienced any other side effects. No treatment was given to the adverse events. Patient did not seek medical attention. At the time of reporting, the patient's status was not provided. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Discomfort, Herpes zoster, Injection site pain, Muscle atrophy
Clinical narrative: Information has been received from a 70 year old female consumer with mild diabetes, high blood pressure, hyperlipidemia, and drug reactions/allergies to sulfa, calcium channel blockers, all statin drugs and pseudoephederine, who on 02-APR-2011 was vaccinated with a dose of ZOSTAVAX (Merck) (lot number, dose and route not provided). Concomitant therapy included sitagliptin phosphate (MSD), multivitamins (unspecified), hydrochlorothiazide (manufacturer unspecified), ubidecarenone, TYLENOL, TRAMADOLOR, losartan potassium (manufacturer unspecified), famotidine (MSD), montelukast sodium (MSD), BYSTOLIC, meloxicam and ezetimibe (MSD). The patient reported that on 02-APR-2011 (also reported as "2 days after receiving the vaccine"), she experienced that her arm was hurting, itching, swollen and that there were actually blisters. The patient stated that it was a bright red rash and that it measured about 1x2 inches. The patient stated that the rash was uncomfortable but that she also experienced a lot of pain at the site. She stated that her doctor said upon examination that the rash was actually an outbreak of the singles. The patient stated this diagnosis was confirmed by her doctor's partner. The patient stated that the rash diminished but had not gone away and that it was a pinkish purple in color and still itched. The patient reported that there were a lump there and a slight indention that she stated felt like was in the muscle. The patient stated that some of the itching had subsided but she sometimes experienced reoccurrences. The patient stated that her arm got very sore when she did any kind of work. The patient stated that her doctor expressed concern over the reaction because she had not been sensitive previously to other vaccines. No treatment was given for the adverse event. No lab studies were performed. At the time of the report, the patient had not recovered. Follow-up information has been received from an unspecified source, concerning the 70 year old female patient, who, on 02-APR-2011 received the ZOSTAVAX (Merck). Reporter stated that, on 04-APR-2011, patient developed a small outbreak of shingles at site of vaccine given (Right deltoid). There was no illness at the time of vaccination. No lab/diagnostic studies were performed. At the time of the report, the patient's outcome was unknown. No further information is available.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Muscle mass, Oedema peripheral, Pain, Pain in extremity, Rash erythematous
Clinical narrative: Information has been received from a 70 year old female consumer with mild diabetes, high blood pressure, hyperlipidemia, and drug reactions/allergies to sulfa, calcium channel blockers, all statin drugs and pseudoephederine, who on 02-APR-2011 was vaccinated with a dose of ZOSTAVAX (Merck) (lot number, dose and route not provided). Concomitant therapy included sitagliptin phosphate (MSD), multivitamins (unspecified), hydrochlorothiazide (manufacturer unspecified), ubidecarenone, TYLENOL, TRAMADOLOR, losartan potassium (manufacturer unspecified), famotidine (MSD), montelukast sodium (MSD), BYSTOLIC, meloxicam and ezetimibe (MSD). The patient reported that on 02-APR-2011 (also reported as "2 days after receiving the vaccine"), she experienced that her arm was hurting, itching, swollen and that there were actually blisters. The patient stated that it was a bright red rash and that it measured about 1x2 inches. The patient stated that the rash was uncomfortable but that she also experienced a lot of pain at the site. She stated that her doctor said upon examination that the rash was actually an outbreak of the singles. The patient stated this diagnosis was confirmed by her doctor's partner. The patient stated that the rash diminished but had not gone away and that it was a pinkish purple in color and still itched. The patient reported that there were a lump there and a slight indention that she stated felt like was in the muscle. The patient stated that some of the itching had subsided but she sometimes experienced reoccurrences. The patient stated that her arm got very sore when she did any kind of work. The patient stated that her doctor expressed concern over the reaction because she had not been sensitive previously to other vaccines. No treatment was given for the adverse event. No lab studies were performed. At the time of the report, the patient had not recovered. Follow-up information has been received from an unspecified source, concerning the 70 year old female patient, who, on 02-APR-2011 received the ZOSTAVAX (Merck). Reporter stated that, on 04-APR-2011, patient developed a small outbreak of shingles at site of vaccine given (Right deltoid). There was no illness at the time of vaccination. No lab/diagnostic studies were performed. At the time of the report, the patient's outcome was unknown. No further information is available.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash pruritic
Clinical narrative: Information has been received from a 70 year old female consumer with mild diabetes, high blood pressure, hyperlipidemia, and drug reactions/allergies to sulfa, calcium channel blockers, all statin drugs and pseudoephederine, who on 02-APR-2011 was vaccinated with a dose of ZOSTAVAX (Merck) (lot number, dose and route not provided). Concomitant therapy included sitagliptin phosphate (MSD), multivitamins (unspecified), hydrochlorothiazide (manufacturer unspecified), ubidecarenone, TYLENOL, TRAMADOLOR, losartan potassium (manufacturer unspecified), famotidine (MSD), montelukast sodium (MSD), BYSTOLIC, meloxicam and ezetimibe (MSD). The patient reported that on 02-APR-2011 (also reported as "2 days after receiving the vaccine"), she experienced that her arm was hurting, itching, swollen and that there were actually blisters. The patient stated that it was a bright red rash and that it measured about 1x2 inches. The patient stated that the rash was uncomfortable but that she also experienced a lot of pain at the site. She stated that her doctor said upon examination that the rash was actually an outbreak of the singles. The patient stated this diagnosis was confirmed by her doctor's partner. The patient stated that the rash diminished but had not gone away and that it was a pinkish purple in color and still itched. The patient reported that there were a lump there and a slight indention that she stated felt like was in the muscle. The patient stated that some of the itching had subsided but she sometimes experienced reoccurrences. The patient stated that her arm got very sore when she did any kind of work. The patient stated that her doctor expressed concern over the reaction because she had not been sensitive previously to other vaccines. No treatment was given for the adverse event. No lab studies were performed. At the time of the report, the patient had not recovered. Follow-up information has been received from an unspecified source, concerning the 70 year old female patient, who, on 02-APR-2011 received the ZOSTAVAX (Merck). Reporter stated that, on 04-APR-2011, patient developed a small outbreak of shingles at site of vaccine given (Right deltoid). There was no illness at the time of vaccination. No lab/diagnostic studies were performed. At the time of the report, the patient's outcome was unknown. No further information is available.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Information has been received from a 74 year old female retired nurse with drug reaction/allergy to BACTRIM and no other pertinent medical history, who on 29-APR-2011 was vaccinated SQ with a dose of ZOSTAVAX (Merck) (lot number not provided). Concomitant therapy included simvastatin (MSD), atenolol, calcium (unspecified), vitamins (unspecified), loratadine (MSD) and omega-3 marine fish oil. The nurse reported that on 30-APR-2011 she developed redness at the injection site; the red area was oblong and approximately 6 inches long. The red area became itchy on 01-MAY-2011. Subsequently, on an unspecified date, the patient stated there was a little sore right in the spot where it was injected. The nurse also stated that her arm was "much better", on 02-MAY-2011. The patient did not seek medical attention. It was unspecified if any treatment was given for the adverse event or if any lab studies were performed. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: VARZOS
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse concerning a 48 month old patient who on 02-MAY-2011 was inadvertently vaccinated subcutaneously with 0.65 mL of ZOSTAVAX (Merck) (Lot# and expiration not reported). No adverse effect was reported. At the time of the reporting the patient's outcome was unknown. Additional information has been requested.
Age: 58.0
Sex: F
Vaccine: HEPA, VARZOS
Symptoms: Rash, Rash vesicular
Clinical narrative: Information has been received from a physician concerning a 58 year old female patient with no pertinent medical history and allergy to sulfa, who on 22-APR-2011 was vaccinated subcutaneously, with a dose of ZOSTAVAX (Merck) (Lot #: 669538/1390Z, Exp: 19-OCT-2012). Secondary suspect administered on 22-APR-2011 included: hepatitis A virus vaccine inactivated (MSD) (Lot #, dose and route not reported). Concomitant therapy included, SYNTHROID, ACTIVELLA, ADACEL, yellow fever virus vaccine, poliovirus vaccine inactivated (unspecified) and typhoid vaccine (unspecified). Physician reported that on 01-MAY-2011 a rash appeared on patient's extremities, which spread to her chest and looked like chickenpox. No treatment was given for the event. No lab/diagnostic studies were performed. Patient sought medical attention through office visit. At the time of the report the patient's outcome was not recovered. Follow-up information has been received from the physician, who reported that the patient completely recovered from the rash on approximately 14-MAY-2011, around 3-4 days ago. No further information is available.