chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: This spontaneous report as received from a nurse refers to two patients of unknown demographics. On an unknown date, the patients were vaccinated with a dose of GARDASIL (Lot number, expiry date and dose were not reported), intramuscularly. On an unknown date, the patients experienced syncope. The healthcare professional present also agreed with the nurse who works for the same practice. It was not stated as to where in the dosing schedule the event syncope had occurred. The outcome of syncope was unknown. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site swelling, Injection site vesicles
Clinical narrative: This spontaneous report as received from a healthcare worker via a company representative, refers to a 4 year old female patient. On 24-APR-2013, the patient was vaccinated with VARIVAX (Merck). Other suspect therapies included MMR II. VARIVAX (Merck) was given only 48 hours after the administration of MMR II. On 24-APR-2013, 3 days after onset of therapy the patient experienced blisters and swelling at the injection site and blisters and swelling at the injection site. The outcome of blisters and swelling at the injection site was reported as recovering/resolving. The action taken with VARIVAX (Merck) was not provided. The reporter did not assess the relationship between the events and VARIVAX (Merck). Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: This spontaneous report as received from a consumer refers to herself, a female patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX. Dosing information was not provided. On an unknown date in April 2013 the patient experienced redness at injection site, size of silver dollar, warm, burning, itch, has small circle after 1 week. The outcome of burning, itch, redness at injection site, size of silver dollar, warm, and has small circle after 1 week, is unknown. The relatedness of the events to ZOSTAVAX was not reported. Additional information has been requested.
Age: 49.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Neuralgia, Secondary transmission, Stress
Clinical narrative: This spontaneous report as received from a consumer regarding her stepson who was 49 year old patient. On 11-APR-2013, the reporter was vaccinated with a dose of ZOSTAVAX (Lot number, expiry date, route and dose were not reported) the day her stepson (patient) came over. The reporter stated that the patient was not in close contact with her. But approximately on 25-APR-2013 (reported as 2 weeks later), the patient experienced shingles via secondary transmission which had occurred on 11-APR-2013, the day the reporter was vaccinated. The patient was treated with LYRICA for the nerve pain from shingles. The outcome of shingles and secondary transmission was unknown. The reporter felt that the event shingles was due to stress related and not due to ZOSTAVAX. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a medical assistant refers to multiple unspecified patients. The medical assistant called regarding a temperature excursion involving RECOMBIVAX, GARDASIL, and ROTATEQ. Vaccines were exposed to 17 F for more than 2 cycles possible 5 cycles since 15-APR-2013. No stability available to support this excursion. Vaccines were administered to multiple unspecified patients on unspecified dates during and after unsupported temperature excursion took place. This case concerns GARDASIL. Lot no. and patient route of administration were not reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Vomiting
Clinical narrative: This spontaneous report was received from a nurse practitioner refers to a female patient of unknown age. The patient had no drug reactions or allergies. On an unknown date, the patient was vaccinated with dose 1 of GARDASIL, (lot number, expiry date and route was not reported). Concomitant medications were not reported. On an unknown date, the patient experienced vomiting 5 minutes after receiving the injection. The outcome of vomiting was reported as recovered. The patient sought medical attention (patient was in the office when AE occurred). Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site nodule
Clinical narrative: Received shots on 4/22/13. Large knot on 4/24/13 in area of vaccine with redness.
Age: 0.52
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC
Symptoms: Injection site rash, Injection site swelling
Clinical narrative: Dtap given RVL- Rash/swelling to leg later that night. Loratadine and Hydrocortisone for treatment.
Age: 39.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Convulsion, Fatigue, Memory impairment, Syncope
Clinical narrative: On 1/10/13 patient stated neighbor saw patient "having a seizure" 2 days ago. Patient also aware of waking up a "couple times" and wondering how he got on sofa. On 2/21/13 MD reports patient had syncope episodes over last several months (at least 4 times) no numbness, tingling, weakness in extremities. 4/26/13 neurologist reports patient states he is "missing a block of time" usually at night, feels "like is waking up". Patient reports about 20 episodes since episodes first started with a "wave" or "pulse" of light and feeling tired with episodes.
Age: 1.0
Sex: M
Vaccine: HIBV, MMR, PNC, VARCEL
Symptoms: Eczema, Rash pruritic, Vaccination complication
Clinical narrative: Patient received VZV vaccine on 3/27/13. Approximately 1 week later she developed diffuse pruritic rash. She was seen at walk in clinic last week and diagnosed with eczema. At visit with PCP on 4/29/13 d/t presentation and onset, diagnosis was likely d/t side effects of varicella vaccine. Prescribed BENADRYL.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity
Clinical narrative: 4-22-13 PNEUMOVAX given (R) deltoid. Developed arm pain 4-23-13 - no redness, edema, fever or heat. 4-24-13 Pain resolved with ice, TYLENOL, rest.
Age: 1.66
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Developed chicken pox 13 days after receiving VARIVAX.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site cellulitis
Clinical narrative: Pt. developed cellulitis at the site of injection 4-20-13 on the arm. Pt went to clinic on 4-21-13. Dx - cellulitis pt started on BACTRIM DS.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: 24 hours after injection 3" warm, red area at site of injection. Applied ice, 48 hours after injection site is red, hot and moderately itchy. Red area 6" long. Referred to PCP. Seen by MD on 4/18/13 recommended ALLEGRA and BENADRYL. 4/19/13 Redness subsiding. 4/25/13 Much improved.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Erythema, Induration, Rash pustular, Swelling, Tenderness
Clinical narrative: Vaccine administered (KINRIX) on 4/18/13 3pm. Noticed swelling and redness on 4/19/13 at night (8pm). Mother called 4/1/13 - 10:30 pm. Seen in office 4/22/13 at 3:45 pm. 10 cms x 9 cms indurating, fading pustules, tender, no localized lymphadenopathy. No fever father gave cold pack at home- relieved with oral antibiotics from 4/22/13.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Burning sensation, Erythema
Clinical narrative: Red burning patch on shoulder getting bigger.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Skin lesion
Clinical narrative: Was seen in our office on 4/9/2013 with lesions on trunk that had started on Sunday. Lesions had started increasing in number by this time.
Age: 0.18
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Eating disorder, Hypophagia, Hypotonia, Pallor
Clinical narrative: Decreased intake. Slept for hours after injection. When family tried to wake patient, he was limp, pale, refused to eat. Taken to ED and monitored until early AM 4-23-13.
Age: 68.0
Sex: F
Vaccine: PNC
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Warm red painful tender (red at injection site 1" diam.) site is tender. Pt. adm. TYLENOL gave relief.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Erythema, Induration
Clinical narrative: Redness and induration, no tenderness approximately 3cm.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Eye pain, Headache, Neurological examination normal
Clinical narrative: HPV #1 (GARDASIL) on 3-15-13. Seen in office 4-11-13 with new onset daily headache approximately 2 weeks after HPV. Bifrontal - sharp stab lateral to (R) orbit and in (R) eye - usually triggered by reading. Normal exam by ophthalmologist.
Age: 62.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site vesicles
Clinical narrative: Pt. given ZOSTAVAX on 4/23/13 (Tuesday). She called today 4/26/13 reported to ZOSTAVAX site, RUA, rash, red itchy occurred first couple days. Today, Friday, has 2 blisters at injection site, size of thumbnail. Is not itching now. Will use cold compress, keep covered with gauze - reassess on Monday. Steroid cream also to red areas.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: (Lt) upper arm with erythema 12x11 cm. (+) edema; Tx: Ibuprofen q 6-8 hours x 48 hours; warm compresses PRN.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Broke out with severe shingles 3 days after ZOSTAVAX.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Feeling abnormal, Headache, Oedema peripheral
Clinical narrative: (L) arm red tender swollen 4 cm. Headache and foggy feeling.
Age: 16.0
Sex: F
Vaccine: HEPA, MNQ
Symptoms: Breath holding, Loss of consciousness, Vomiting
Clinical narrative: Within 60 sec of receiving vaccines, pt held breath and lost consciousness for approximately 30 seconds, after which she vomited, HR was in 40's and returned to baseline of approximately 70 BPM over next 2-3 min. Within 15 min, pt denied any ongoing symptoms.
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Lymphadenopathy
Clinical narrative: Pt was administered the BOOSTRIX vaccine on 4/1/13. Pt returned to office 4/6/13 c/o lymphadenopathy in the arm.
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a patient of unknown age and gender. On 27-SEP-2012 the patient was vaccinated with dose 1, 0.5 milliliter (ml) VAQTA (lot#, expiration date and route not reported). On 26-MAR-2013 the patient was vaccinated with dose 2 (administered a day earlier than the 6 month mark), 0.5 VAQTA. No adverse effect reported. Nurse reported she would check with her manager on which information it was okay for her to provide and would call back with follow-up information. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age. The patient was vaccinated with the first dose of GARDASIL (dose and lot # not reported) on 21-JUN-2011, the second dose of GARDASIL (dose and lot # not reported) on 31-AUG-2011 and was in the office "today" (19-APR-2013) (dose and lot # not reported) to receive the third dose of GARDASIL. No adverse event reported. It was unspecified if the patient had sought medical attention. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to patients of unknown age and gender. On an unknown date, 1 to 3 days before the six month scheduled booster, an unspecified number of patients were vaccinated with dose 2 0.5 milliliter (ml) VAQTA (lot # and expiration date not reported) intramuscularly. No adverse effects have been reported. Additional information is not expected.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site discomfort, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Swollen left thigh, warmth and redness for 3 1/2 days. Mild discomfort.
Age: 39.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Chills, Erythema, Induration, Injection site pain
Clinical narrative: Vaccines as listed in #13 administered on 4/15 along with TB test (L) volar forearm. States (L) deltoid sore next day. Noted hard area size of quarter on 4/20 with some redness. Area redness extended to max of 3 1/2" x 2" wide. Noted chills on 4/21 and to ER. No fever no labs. Put on KEFLEX, BENADRYL, ADVIL.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, HIBV, MMR, VARCEL
Symptoms: Agitation, Eye swelling, Fatigue, Irritability, Pain
Clinical narrative: 2-6-13 9:30 AM Approximately 30 minutes following vaccination c/o right eye swollen. Caregiver administered BENADRYL q4 hours x 2. C/o sneezing and runny nose. 5:00 PM approximately, c/o fever 101.3. Caregiver administered MOTRIN every 4 hours. 9:00 PM vomited, low grade fever 100. 2-7-13 1:00 AM vomited, low grade fever 100. Caregiver administered PHENERGAN Suppository. C/o low grade fever throughout day. 8:00 PM low grade fever 100. 2-8-13 Right eye swelling subsided. No fever. C/o achy. 2-9-13 through 2-11-13 Appetite good. C/o tired, agitated, cranky. 2-13-13 Fully recovered.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, HIBV, MMR, VARCEL
Symptoms: Pyrexia, Rhinorrhoea, Sneezing, Vomiting
Clinical narrative: 2-6-13 9:30 AM Approximately 30 minutes following vaccination c/o right eye swollen. Caregiver administered BENADRYL q4 hours x 2. C/o sneezing and runny nose. 5:00 PM approximately, c/o fever 101.3. Caregiver administered MOTRIN every 4 hours. 9:00 PM vomited, low grade fever 100. 2-7-13 1:00 AM vomited, low grade fever 100. Caregiver administered PHENERGAN Suppository. C/o low grade fever throughout day. 8:00 PM low grade fever 100. 2-8-13 Right eye swelling subsided. No fever. C/o achy. 2-9-13 through 2-11-13 Appetite good. C/o tired, agitated, cranky. 2-13-13 Fully recovered.
Sex: M
Vaccine: HEP
Symptoms: Administration site pain, Bone pain, Pain
Clinical narrative: Reports usual administration site pain but on third day post vaccine developed bone pain in arm at elbow and shoulder. Pain increases with position change of arm or with increased movement of arm. Has not declined with time.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Herpes zoster, Nervous system disorder, Pruritus
Clinical narrative: Came down with shingles 3 days after injection. Still have burning and itching after 7 weeks and many meds to alleviate symptoms and nerve "fireworks".
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypersensitivity, Injection site erythema, Injection site warmth, Pain in extremity
Clinical narrative: Arm has dark red circle around injection, with a large ring of red around injection, warm to touch and arm very painful. Pt took BENADRYL and felt relief after 1 day. Was allergic reaction according to Dr.
Age: 0.34
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RVX
Symptoms: Allergy test negative, Swollen tongue
Clinical narrative: 10:15 am -vaccines given, early afternoon tongue swelling. Advice nurse said give BENADRYL and come in if gets worse, 6pm went to ER as BENADRYL didn't help and swelling was worse, Dr gave steroid and said continue BENADRYL for 24 hrs, 2am swelling returned, back to ER they watched him and sent us home at 6am.
Age: 38.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Erythema, Injection site erythema, Pain in extremity
Clinical narrative: Tdap and MMR given left arm on 4-17-13, pt reports to HD on 4-24-13 with c/o pain/soreness in right arm and redness at site and below. Pt reports last Td in 2011.
Age: 10.0
Sex: M
Vaccine: FLU3, HEPA, MMRV, TDAP
Symptoms: Blister, Injection site vesicles, Pruritus
Clinical narrative: Within 24 hrs of receiving vaccines listed in #13, client developed vesicles near MMRV vaccine site and on arms & thighs. As of 4/19/13, client had no fever or malaise. Vesicles itched.
Age: 70.0
Sex: F
Vaccine: FLU3, TDAP, VARZOS
Symptoms: Dry skin, Pain in extremity, Pruritus generalised, Rash generalised
Clinical narrative: Arms were painful & did not improve developed rash & itchy over entire body within month. Cont to have pain in both arms & then legs. Rash remained stated cont. to itch. 11/13 improvement 11/26 rash gone but (R) arm & leg pain cont. 12/4 - dry skin (L) arm, legs ache along with (L) & (R) arm. 12/10 - Dr follow-up. Took hydroxyzine & prednisone. 4/13 cont. prednisone, pain in arms & legs.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient was given ZOSTAVAX on 4/13/12, she called 4/15 that injection site was red, swollen, hot to touch and worse then day before. Instructed patient to seek medical attention.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Dizziness, Seizure like phenomena, Vomiting
Clinical narrative: Gave patient ZOSTAVAX injection, pt. started feeling week and dizzy, pt looked as if he was seizing, gave pt a dose of Epi-pen. Pt then vomited and then started feeling better. Fire Dept arrived check him out and then pt said was feeling better and didn't want to go to ED. Called pt about 1 hr later, he said he was feeling fine and did not think it was the vaccine.
Age: 1.15
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Petechiae
Clinical narrative: Petechiaes in face no treatment.
Age: 24.0
Sex: U
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: None stated.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a physician via a company representative concerning a patient of unknown age and gender. On an unknown date (recently), the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiry date, dose and route unspecified). No concomitant medications were reported. On an unknown date, the patient broke out with shingles after the vaccination. On an unknown date, the patient sought medical attention (saw the healthcare professional). The outcome of the event was unknown. The relatedness for the event was unknown for ZOSTAVAX. Follow up information was received from the physician concerning a patient. Medical history of the patient included chickenpox. There was no history of Herpes Zoster. On 01-MAR-2007, the patient was vaccinated with a dose of ZOSTAVAX (lot number and expiry date reported as 654604/1406F and 17-FEB-2008 respectively) at a private doctor office or hospital. There was no illness at the time of vaccination. There was no rash at the site of injection or elsewhere within 42 days of vaccination. There was no recent exposure of chickenpox or Herpes Zoster. On 04-FEB-2013, the patient experienced shingles left chest wall severe outbreak. The event resulted in persistent or significant disability/ incapability. Thoracic region (T10, T11, T12) was involved. Maximum pain was reported (value 10 on a scale from 1 to 10). No specimen was collected polymerase chain reaction (PCR). No other diagnostic tests were performed. The outcome of the event was reported as not resolved as the patient still had the post herpetic neuralgia. A signed informed consent form was obtained. Additional information is not expected.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pain, Polymerase chain reaction
Clinical narrative: This spontaneous report was received from a physician via a company representative concerning a patient of unknown age and gender. On an unknown date (recently), the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiry date, dose and route unspecified). No concomitant medications were reported. On an unknown date, the patient broke out with shingles after the vaccination. On an unknown date, the patient sought medical attention (saw the healthcare professional). The outcome of the event was unknown. The relatedness for the event was unknown for ZOSTAVAX. Follow up information was received from the physician concerning a patient. Medical history of the patient included chickenpox. There was no history of Herpes Zoster. On 01-MAR-2007, the patient was vaccinated with a dose of ZOSTAVAX (lot number and expiry date reported as 654604/1406F and 17-FEB-2008 respectively) at a private doctor office or hospital. There was no illness at the time of vaccination. There was no rash at the site of injection or elsewhere within 42 days of vaccination. There was no recent exposure of chickenpox or Herpes Zoster. On 04-FEB-2013, the patient experienced shingles left chest wall severe outbreak. The event resulted in persistent or significant disability/ incapability. Thoracic region (T10, T11, T12) was involved. Maximum pain was reported (value 10 on a scale from 1 to 10). No specimen was collected polymerase chain reaction (PCR). No other diagnostic tests were performed. The outcome of the event was reported as not resolved as the patient still had the post herpetic neuralgia. A signed informed consent form was obtained. Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HPV2, MNQ, VARCEL
Symptoms: Acute stress disorder, Catatonia, Convulsion
Clinical narrative: Initial report was received from a healthcare professional through another manufacturer on 19 April 2013 under reference number A1019304A. The following is verbatim from the report: "This case was reported by a healthcare professional (nurse) via sales representative and described the occurrence of seizure in a 17-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline), MENACTRA (non-gsk) and VARIVAX (non-gsk). On 28 March 2013 the subject received 1st dose of CERVARIX (unknown details), MENACTRA and VARIVAX, the subject experienced seizure. The nurse "heard from a third party that the girl was having seizure two hours after vaccination." The subject was seen by a doctor of a clinic "on the same day as the vaccination" who "told the mother that the girl has PRM a stress disorder." The next day the subject had no symptoms. On 30 March 2013, 2 days after vaccination with CERVARIX, MENACTRA, and VARIVAX, the subject experienced seizure and catatonic state ("still in a catatonic mood"). The subject was hospitalized and the healthcare professional considered the events were clinically significant (or requiring intervention). At the time of reporting the events were worse. The healthcare professional considered the events were possibly related to vaccination with CERVARIX, MENACTRA and VARIVAX." Outcome was not recovered. Documents held by sender: None.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Hypersensitivity, Rash erythematous, Rash pruritic
Clinical narrative: Patient experienced rash 1 week after vaccination. Rash on 1 side of stomach, 1 side of head, as well as neck region and wrists. At 3 weeks after vaccination, Pt. says new rash spots are showing up Pt. saw her doctor and was given MEDROL Dosepak and Betamethasone Cr. Diagnosis not yet determined.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Hypersensitivity, Rash
Clinical narrative: Patient experienced rash 1 week after vaccination. Rash on 1 side of stomach, 1 side of head, as well as neck region and wrists. At 3 weeks after vaccination, Pt. says new rash spots are showing up Pt. saw her doctor and was given MEDROL Dosepak and Betamethasone Cr. Diagnosis not yet determined.
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, Pneumonia viral
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a female patient of unknown age. The physician reported that he heard of the case where another physician administered standard(0.65ml) ZOSTAVAX (lot number not provided) subdermally vaccine to the patient on an unknown date. The patient then developed Viral pneumonia after receiving ZOSTAVAX. Treatment was given for adverse event. The patient was hospitalization and the viral pneumonia was considered to be life threatening. The outcome of adverse event was unknown. The relatedness for Viral pneumonia was unknown for ZOSTAVAX. Additional information is not expected.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Joint swelling, Pyrexia, Rash
Clinical narrative: This spontaneous report as received from a 62 year old female consumer refers herself. No pertinent medical history and no drug reactions/allergies. On an unknown date the patient was vaccinated with ZOSTAVAX (dose, route and lot# not reported, expired date 09-APR-2013). There was no concomitant therapy. The patient reported an AE that occurred after receiving ZOSTAVAX. The patient was admitted into the hospital (approximately in October 2011) with severe swelling to the ankles, rash and high uncontrollable fever. The onset date of all AEs was 02-OCT-2011. The patient saw the doctor and no treatment was given. At the time of reporting, the patient was recovering. The relationship between all events and ZOSTAVAX was not reported. Additional information has been requested.
Age: 77.0
Sex: M
Vaccine: PPV
Symptoms: C-reactive protein, Cardiac enzymes, Encephalopathy, Full blood count, International normalised ratio
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a 77 year old male patient with benign prostatic hyperplasia, bradycardia, memory loss, peripheral neuropathy, obstructive sleep apnea, chronic peripheral edema, rheumatoid arthritis, sinus node dysfunction, atherosclerotic cardiovascular disease, diastolic dysfunction, esophagus hiatal hernia, metabolic bone disease, chronic COUMADIN anticoagulation, erectile dysfunction, chronic kidney disease stage 3 and type 2 diabetes mellitus. The patient's medical history included coronary artery bypass grafting (4 times) and history of shingles. On 24-APR-2013, the patient was vaccinated with a dose of PNEUMOVAX23 (Lot number was reported as 8022062, expiry date was 28-FEB-2014, route and dose was not reported). Concomitant therapies included PLAVIX, PRILOSEC, aspirin, COLACE, AVODART, FISH OIL, LASIX, gabapentin, glipizide, ARAVA, SYNTHROID, minerals (unspecified), CENTRUM, potassium chloride, LYRICA and ULTRAM. On 24-APR-2013, the patient presented to the Emergency Department with a fever (medically significant, disability and life threatening), an unresponsive episode (medically significant, disability and life threatening) and encephalopathy (medically significant, disability and life threatening) after receiving PNEUMOVAX23. The patient also had unspecified "pneumonia symptoms" (medically significant, disability and life threatening) upon arrival to the Emergency Room. The patient sought medical attention. The patient was admitted to the hospital on 24-APR-2013 and was treated with unspecified steroids, and ROCEPHIN and Azithromycin. Diagnostic test performed included blood work: CBC (Complete blood count), CMP (Comprehensive Metabolic Panel), CRP (C-reactive protein), PT/INR (prothrombin time), fasting lipid profile and cardiac enzymes. The test results were not provided. The outcome of encephalopathy, fever, unspecified pneumonia symptoms and an unresponsive episode was reported as recovering/resolving. Additional information has been requested.
Age: 77.0
Sex: M
Vaccine: PPV
Symptoms: Lipids, Metabolic function test, Pneumonia, Prothrombin time, Pyrexia
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a 77 year old male patient with benign prostatic hyperplasia, bradycardia, memory loss, peripheral neuropathy, obstructive sleep apnea, chronic peripheral edema, rheumatoid arthritis, sinus node dysfunction, atherosclerotic cardiovascular disease, diastolic dysfunction, esophagus hiatal hernia, metabolic bone disease, chronic COUMADIN anticoagulation, erectile dysfunction, chronic kidney disease stage 3 and type 2 diabetes mellitus. The patient's medical history included coronary artery bypass grafting (4 times) and history of shingles. On 24-APR-2013, the patient was vaccinated with a dose of PNEUMOVAX23 (Lot number was reported as 8022062, expiry date was 28-FEB-2014, route and dose was not reported). Concomitant therapies included PLAVIX, PRILOSEC, aspirin, COLACE, AVODART, FISH OIL, LASIX, gabapentin, glipizide, ARAVA, SYNTHROID, minerals (unspecified), CENTRUM, potassium chloride, LYRICA and ULTRAM. On 24-APR-2013, the patient presented to the Emergency Department with a fever (medically significant, disability and life threatening), an unresponsive episode (medically significant, disability and life threatening) and encephalopathy (medically significant, disability and life threatening) after receiving PNEUMOVAX23. The patient also had unspecified "pneumonia symptoms" (medically significant, disability and life threatening) upon arrival to the Emergency Room. The patient sought medical attention. The patient was admitted to the hospital on 24-APR-2013 and was treated with unspecified steroids, and ROCEPHIN and Azithromycin. Diagnostic test performed included blood work: CBC (Complete blood count), CMP (Comprehensive Metabolic Panel), CRP (C-reactive protein), PT/INR (prothrombin time), fasting lipid profile and cardiac enzymes. The test results were not provided. The outcome of encephalopathy, fever, unspecified pneumonia symptoms and an unresponsive episode was reported as recovering/resolving. Additional information has been requested.
Age: 77.0
Sex: M
Vaccine: PPV
Symptoms: Unresponsive to stimuli
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a 77 year old male patient with benign prostatic hyperplasia, bradycardia, memory loss, peripheral neuropathy, obstructive sleep apnea, chronic peripheral edema, rheumatoid arthritis, sinus node dysfunction, atherosclerotic cardiovascular disease, diastolic dysfunction, esophagus hiatal hernia, metabolic bone disease, chronic COUMADIN anticoagulation, erectile dysfunction, chronic kidney disease stage 3 and type 2 diabetes mellitus. The patient's medical history included coronary artery bypass grafting (4 times) and history of shingles. On 24-APR-2013, the patient was vaccinated with a dose of PNEUMOVAX23 (Lot number was reported as 8022062, expiry date was 28-FEB-2014, route and dose was not reported). Concomitant therapies included PLAVIX, PRILOSEC, aspirin, COLACE, AVODART, FISH OIL, LASIX, gabapentin, glipizide, ARAVA, SYNTHROID, minerals (unspecified), CENTRUM, potassium chloride, LYRICA and ULTRAM. On 24-APR-2013, the patient presented to the Emergency Department with a fever (medically significant, disability and life threatening), an unresponsive episode (medically significant, disability and life threatening) and encephalopathy (medically significant, disability and life threatening) after receiving PNEUMOVAX23. The patient also had unspecified "pneumonia symptoms" (medically significant, disability and life threatening) upon arrival to the Emergency Room. The patient sought medical attention. The patient was admitted to the hospital on 24-APR-2013 and was treated with unspecified steroids, and ROCEPHIN and Azithromycin. Diagnostic test performed included blood work: CBC (Complete blood count), CMP (Comprehensive Metabolic Panel), CRP (C-reactive protein), PT/INR (prothrombin time), fasting lipid profile and cardiac enzymes. The test results were not provided. The outcome of encephalopathy, fever, unspecified pneumonia symptoms and an unresponsive episode was reported as recovering/resolving. Additional information has been requested.
Age: 18.0
Sex: M
Vaccine: HPV4
Symptoms: Crohn's disease, Gastric disorder
Clinical narrative: This spontaneous report was received from a consumer refers to her 18 year old son (male patient) with no pertinent medical history and drug reactions/allergies. On 24-FEB-2013, the patient was vaccinated with dose 1, GARDASIL (lot#, expiration date and route not reported). No concomitant medications were reported. Approximately on an unknown date in March 2013, the patient suffered severe stomach problems after the GARDASIL vaccine, was hospitalized and diagnosed with Crohn's disease. Approximately on 10-MAR-2013, the patient was hospitalized (reported as 2 weeks after his first dose of GARDASIL). Consumer stated that her son was in good health prior to receiving the GARDASIL vaccine. An unspecified treatment was rendered for the event. The patient was recovering from the event at the time of this report. No intervention was done to prevent the seriousness criteria. The consumer had further questions about the second injection of GARDASIL, she was advised to contact her physician. Causality was not reported. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site inflammation
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 65 year old female patient. Pertinent medical history was none. On 23-APR-2013, the patient was vaccinated with ZOSTAVAX (Lot # J000435, expiry date was 10-APR-2014), 0.65 milliliter (ml), subcutaneously. No concomitant medications were taken. Approximately on an unknown date in April 2013 (reported as now), the patient experienced inflammation and redness at the injection site. Diagnostic test performed was none. The patient sought medical attention (called the pharmacy) and no treatment was provided. The outcome of inflammation and redness at the injection site was reported as not recovered/not resolved. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Rash erythematous
Clinical narrative: This spontaneous report as received from a patient regarding herself who was also a health professional of unknown age via a company representative. Approximately on an unknown date in April 2013, the patient was vaccinated with a dose of ZOSTAVAX (Lot number, expiry date were not reported), 0.65 milliliter (ml), subcutaneously. Around the same time frame approximately on an unknown date in April 2013, the patient was also vaccinated with a dose of PNEUMOVAX 23 (Lot number, expiry date, route and dose were not reported). Approximately on an unknown date in April 2013, the patient reported red circle rash spots at each injection site. These spots were still there but slightly fading and visibly improved. The outcome of red circle rash spots at each injection site was reported as recovering/resolving. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 63 year old female patient who was allergic to Demerol, latex and sulfa. On 22-APR-2013, the patient was vaccinated with a dose of ZOSTAVAX (Lot number # H022152, expiry date was 18-MAR-2014), 0.65 milliliter (ml), subcutaneously. The reporter stated that since the patient was allergic to latex the pharmacist had used latex free gloves, syringe and bandage. The reporter had observed that the injection area was a little red just after receiving ZOSTAVAX on 22-APR-2013. The patient sought medical attention, contacted an unspecified physician who prescribed a MEDROL dose pack on 23-APR-2013 yet the patient stated that her condition was getting worse. On 24-APR-2013, the patient had described the area to be red and the size of a dollar bill and also reported that site as hard. The outcome of injection area to be red was reported as not recovered/not resolved. The outcome of the site was hard was unknown. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 66 year old female patient (who reported to the ZOSTAVAX rebate program) with rheumatoid arthritis (RA) and immune system low because of drugs for RA. The patient's medical history included shingles on an unknown date in 1957, at the age of 11. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (Lot number, expiry date, route and dose were not reported). On an unknown date, the patient reported of having redness, swelling, hard lump and warmth at the injection site after getting ZOSTAVAX. The patient reported that it was better than shingles. The outcome of redness, swelling, hard lump and warmth at the injection site is unknown. Additional information is not expected.
Sex: U
Vaccine: MMR
Symptoms: Measles antibody positive, Mumps antibody test positive, Rubella antibody negative
Clinical narrative: This spontaneous report was received from a licensed practical nurse concerning a patient of unknown age and gender. On an unknown date, the patient was vaccinated with a dose of MMR II (lot number, expiry date, dose and route unspecified). No concomitant medications were reported. On an unknown date, titers for measles, mumps, and rubella were drawn and serologic testing showed immunity to measles and mumps and equal to rubella. Outcome of the event was unknown. The relatedness for the event was unknown for MMR II. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a physician via a company representative concerning a female patient of unknown age. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiry date, dose and route unspecified). No concomitant medications were reported. On an unknown date, the patient experienced shingles after receiving ZOSTAVAX. The patient sought medical attention (doctor visit). The patient was treated with unspecified antiviral medication and unspecified pain medication. No lab tests were performed. The outcome of the event was unknown. The relatedness for the event was unknown for ZOSTAVAX. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Drug administered at inappropriate site, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a patient of unknown age. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiry date was not reported and route was subcutaneous). Concomitant medications were not reported. The nurse reported that she properly administered ZOSTAVAX, subcutaneously in the deltoid muscle but the patient felt that the dose was not administered properly (should have been administered in the back of the upper arm. No adverse effect was reported. Additional information is not expected.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a consumer regarding her sister in law who was an 80 year old patient. Approximately on an unknown date in 2008 (reported as 5 years back) the patient was vaccinated with a dose of ZOSTAVAX (Lot number expiry date, route and dose were not reported). Approximately on an unknown date in April 2013 (reported as last week), the patient broke out in shingles on her back. The reporter wanted to know if a booster was needed since she and her husband were also vaccinated around the same time. The outcome of broke out in shingles on her back was unknown. Additional information is not expected.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Burning sensation, Erythema, Herpes zoster, Pain
Clinical narrative: This spontaneous report as received from a consumer refers to a 82 year old female patient. On an unknown date in 2007 or 2008, the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiry date was not reported, route was under the skin in her arm). Concomitant medications were not reported. The patient had shingles a few years after getting the vaccine. She went to the emergency room on an unknown date in FEB-2013, with burning, itching red blisters under her breast going in a strip to her back. The patient stated that today she woke up with red spots on her right ankle and groin that are itching and hurt. Treatment rendered for the events included valacyclovir and prednisone. The outcome of the reported events were unknown. The patient sought medical attention. Additional information is not expected.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash erythematous
Clinical narrative: This spontaneous report as received from a consumer refers to a 82 year old female patient. On an unknown date in 2007 or 2008, the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiry date was not reported, route was under the skin in her arm). Concomitant medications were not reported. The patient had shingles a few years after getting the vaccine. She went to the emergency room on an unknown date in FEB-2013, with burning, itching red blisters under her breast going in a strip to her back. The patient stated that today she woke up with red spots on her right ankle and groin that are itching and hurt. Treatment rendered for the events included valacyclovir and prednisone. The outcome of the reported events were unknown. The patient sought medical attention. Additional information is not expected.
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema
Clinical narrative: Erythema (L) arm  from center of arm.
Age: 61.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Oedema peripheral
Clinical narrative: Pt. received Tdap on 4/4/13 came back to clinic with complaint of full arm edema, (+) FROM, slight redness at deltoid.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Biopsy skin, Blood test, Body temperature increased, Full blood count, Granuloma annulare
Clinical narrative: This spontaneous report was received from a 75-year-old female patient regarding herself. Current conditions included asthma, Chronic Obstructive Pulmonary Disease (COPD) and DEMEROL allergy. On 27-MAR-2013 the patient was re-vaccinated with a dose of PNEUMOVAX 23 (lot#, expiration date not reported), subcutaneously. Concomitant therapies included acyclovir and omeprazole. The patient reported that after being revaccinated she experienced on 27-MAR-2013, the following events: pain at the injection site for five days, a temperature of 101 degrees for two days, numbness in her arms, constant headaches and pains in her hands, neck and rib cage. The patient states she felt like she had sunburn on her arms and head and developed lesions in both areas. When the patient sought medical attention, she stated her physician diagnosed her with annular elastocytic cell granuloma. Patient was on 'physical therapy' as the treatment for the events. Lab diagnostic studies such as CBC blood test and biopsy of lesions were performed, result unknown. The patient was recovering from the events. Causality was not reported. Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Headache, Hypoaesthesia, Injection site pain, Musculoskeletal chest pain, Neck pain
Clinical narrative: This spontaneous report was received from a 75-year-old female patient regarding herself. Current conditions included asthma, Chronic Obstructive Pulmonary Disease (COPD) and DEMEROL allergy. On 27-MAR-2013 the patient was re-vaccinated with a dose of PNEUMOVAX 23 (lot#, expiration date not reported), subcutaneously. Concomitant therapies included acyclovir and omeprazole. The patient reported that after being revaccinated she experienced on 27-MAR-2013, the following events: pain at the injection site for five days, a temperature of 101 degrees for two days, numbness in her arms, constant headaches and pains in her hands, neck and rib cage. The patient states she felt like she had sunburn on her arms and head and developed lesions in both areas. When the patient sought medical attention, she stated her physician diagnosed her with annular elastocytic cell granuloma. Patient was on 'physical therapy' as the treatment for the events. Lab diagnostic studies such as CBC blood test and biopsy of lesions were performed, result unknown. The patient was recovering from the events. Causality was not reported. Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Skin lesion
Clinical narrative: This spontaneous report was received from a 75-year-old female patient regarding herself. Current conditions included asthma, Chronic Obstructive Pulmonary Disease (COPD) and DEMEROL allergy. On 27-MAR-2013 the patient was re-vaccinated with a dose of PNEUMOVAX 23 (lot#, expiration date not reported), subcutaneously. Concomitant therapies included acyclovir and omeprazole. The patient reported that after being revaccinated she experienced on 27-MAR-2013, the following events: pain at the injection site for five days, a temperature of 101 degrees for two days, numbness in her arms, constant headaches and pains in her hands, neck and rib cage. The patient states she felt like she had sunburn on her arms and head and developed lesions in both areas. When the patient sought medical attention, she stated her physician diagnosed her with annular elastocytic cell granuloma. Patient was on 'physical therapy' as the treatment for the events. Lab diagnostic studies such as CBC blood test and biopsy of lesions were performed, result unknown. The patient was recovering from the events. Causality was not reported. Additional information has been requested.
Age: 31.0
Sex: M
Vaccine: FLUX
Symptoms: Activities of daily living impaired, Antibody test negative, Antinuclear antibody negative, Areflexia, Balance disorder
Clinical narrative: Initial case was retrieved from the scientific literature on 15 April 2013. Verbatim from the report: "A 31-year-old healthy man developed slowly progressive distal symmetric paresthesias and numbness, poor balance, and gait instability 2 months after influenza vaccine. His symptoms worsened over the following 4 months. At his nadir, numbness affected his hands below the wrists and legs below the knees. Balance was unsteady, especially in the dark. He was not able to run. Walking short distances could be achieved with minimal support but he used a wheelchair for longer distances. Examination was notable for decreased vibration and pin sensation in his hands and feet, areflexia, and mild weakness of toe extension. Gait was slow and broad based. Serum laboratory studies revealed normal vitamin B12, anti-Ro, anti-La, and serum immunofixation. MAG antibodies were absent. Cerebral spinal fluid demonstrated mild albuminocytologic dissociation (protein, 55 mg/dL). NCS showed prolonged distal latency in median, ulnar, peroneal, and tibial motor nerves (30%-50% above upper limit of normal) and median, ulnar, and sural sensory nerves. The F waves were absent (median) or mildly prolonged. Partial conduction block was present in the right ulnar nerve forearm segment (30% amplitude reduction). Martin-Gruber anastomosis was not present. Limb temperature was more than 33 degrees C. Two grams per kilogram of IVIG was initiated 4 months after symptom onset. One gram per kilogram of IVIG was repeated every 3 weeks. Over the following 6 months, symptoms and signs improved. He continued to experience mild intermittent paresthesias in his fingers and toes but numbness resolved. Examination revealed normal perception of vibration and pin in his hands and feet. Reflexes normalized. Gait was narrow, and he could perform tandem gait without difficulty. He was able to resume exercise, and reported running 3 consecutive miles at 8 hours and 30 minutes per mile pace. IVIG was discontinued without relapse in symptoms." The reporter for this case is the same as for case 2013-05405. Documents held by sender: none.