chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 87.0
Sex: F
Vaccine: FLUA3, VARZOS
Symptoms: Injected limb mobility decreased, Injection site pain, Injection site reaction, Muscular weakness, Tendonitis
Clinical narrative: Severe right shoulder pain and deltoid tendonitis with confirmed weakness of the right arm and new limitation in right shoulder range of motion.
Age: 87.0
Sex: F
Vaccine: FLUA3, VARZOS
Symptoms: X-ray limb
Clinical narrative: Severe right shoulder pain and deltoid tendonitis with confirmed weakness of the right arm and new limitation in right shoulder range of motion.
Age: 1.0
Sex: M
Vaccine: FLU4, HEPA, MMR, VARCEL
Symptoms: Erythema, Skin induration, Skin warm
Clinical narrative: Reddened warm and hard to the touch. Mother has tried cool compresses. Has not been bothersome to child only to mother of child.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Impaired work ability, Injection site erythema, Injection site pain
Clinical narrative: On Day 1 (10/15) injection site became reddened. On Day 2 site became reddened, swollen, very painful, warm to touch and low grade fever (100.7) developed. On Day 3 injection site more swollen, extremely red and warm, painful to touch, fatigue, low grade fever continued. Left work early. On Day 4 (10/18) called in sick to work. Injection site is very red and swollen, warm to touch and very painful. Severe fatigue. Swelling has now traveled to left shoulder, left neck and throat and left side of face. Notified PCP, started a MEDROL DOSEPAK at 4pm on day 4. Day 5 (today) went to work, felt very good this morning but by 1pm swelling in left shoulder, neck, face and throat and low grade fever has returned. Also developed headache. Injection site remains red, not as bad as previous day but still warm to touch. Left side of throat painful.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Injection site warmth, Oropharyngeal pain, Pharyngeal oedema, Pyrexia
Clinical narrative: On Day 1 (10/15) injection site became reddened. On Day 2 site became reddened, swollen, very painful, warm to touch and low grade fever (100.7) developed. On Day 3 injection site more swollen, extremely red and warm, painful to touch, fatigue, low grade fever continued. Left work early. On Day 4 (10/18) called in sick to work. Injection site is very red and swollen, warm to touch and very painful. Severe fatigue. Swelling has now traveled to left shoulder, left neck and throat and left side of face. Notified PCP, started a MEDROL DOSEPAK at 4pm on day 4. Day 5 (today) went to work, felt very good this morning but by 1pm swelling in left shoulder, neck, face and throat and low grade fever has returned. Also developed headache. Injection site remains red, not as bad as previous day but still warm to touch. Left side of throat painful.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling, Swelling face
Clinical narrative: On Day 1 (10/15) injection site became reddened. On Day 2 site became reddened, swollen, very painful, warm to touch and low grade fever (100.7) developed. On Day 3 injection site more swollen, extremely red and warm, painful to touch, fatigue, low grade fever continued. Left work early. On Day 4 (10/18) called in sick to work. Injection site is very red and swollen, warm to touch and very painful. Severe fatigue. Swelling has now traveled to left shoulder, left neck and throat and left side of face. Notified PCP, started a MEDROL DOSEPAK at 4pm on day 4. Day 5 (today) went to work, felt very good this morning but by 1pm swelling in left shoulder, neck, face and throat and low grade fever has returned. Also developed headache. Injection site remains red, not as bad as previous day but still warm to touch. Left side of throat painful.
Age: 70.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Arthralgia, Injection site pain
Clinical narrative: Patient reports injection itself was painful and located rather high up in the deltoid (higher than flu shot given in left arm). Almost immediately after injection, patient reports sharp pain located in one specific location of upper arm, close to shoulder. (Patient is able to physically pinpoint exact location of pain). Pain has gotten steadily worse in the 3 days since the vaccination was administered.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Loss of consciousness, Malaise, Nausea, Urinary tract infection
Clinical narrative: After receiving the latest shingles shot I began to feel nauseated that night and about 6 the next morning I passed out twice in the house.
Age: 22.0
Sex: F
Vaccine: FLU4
Symptoms: Neuralgia, Pain, Pain in extremity
Clinical narrative: Patient is describing a "nerve-like" pain that begin a few days after the vaccination. At rest there is no pain but if she brings her arm abover her head, behind her body or crosses her body she feels the radiating pain from about shoulder level to elbow. She has used ice packs and Alieve starting shortly before 10/19/18 and states she has had some relief from this treatment. She has not seen a physician. She is planning to wait to see if the ice pack and pain relievers help any.
Age: 14.0
Sex: M
Vaccine: HPV9
Symptoms: Blood test, Hypoaesthesia, Laboratory test normal, Mononucleosis heterophile test negative, Pain in extremity
Clinical narrative: 10/18/18 Mother reported child had fever (mother did not have thermometer), numbness in legs, pain down his spine and pain in his arms. Nurse advised mother to have child seen by MD today. 10/19/18-Nurse called and spoke with mother. Mother reported child was seen in hospital ER on 10/18/18. Mother stated child had lab-work which was negative for mono and UTI and additional lab-work which were also negative. Temperature at time of ER visit was 100.4 (Mother had given child TYLENOL 30 minutes prior). As per mother, child was diagnosed with HPV vaccine side effects. Child was discharged home with instructions to take TYLENOL alternating with MOTRIN. Child has no abnormal symptoms today and attended school.
Age: 14.0
Sex: M
Vaccine: HPV9
Symptoms: Pyrexia, Spinal pain, Urine analysis normal, Vaccination complication
Clinical narrative: 10/18/18 Mother reported child had fever (mother did not have thermometer), numbness in legs, pain down his spine and pain in his arms. Nurse advised mother to have child seen by MD today. 10/19/18-Nurse called and spoke with mother. Mother reported child was seen in hospital ER on 10/18/18. Mother stated child had lab-work which was negative for mono and UTI and additional lab-work which were also negative. Temperature at time of ER visit was 100.4 (Mother had given child TYLENOL 30 minutes prior). As per mother, child was diagnosed with HPV vaccine side effects. Child was discharged home with instructions to take TYLENOL alternating with MOTRIN. Child has no abnormal symptoms today and attended school.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site discomfort, Injection site pain, Joint range of motion decreased, Myalgia
Clinical narrative: In the first 72 hours after the vaccination, patient had significant muscular pain and difficulty with full range of motion. This improved slightly but at 17 days post-injection patient continues report significant discomfort and pain in the left deltoid region. She has used NSAIDs with some relief. Discussed ice/heat and activity with patient. We are continuing to follow-up regarding the case.
Age: 54.0
Sex: F
Vaccine: PNC13
Symptoms: Nausea, Pyrexia, Rash, Swelling
Clinical narrative: I have, swelling, rash, fever, nausea, and chills.
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pain, Pruritus
Clinical narrative: Noted soreness evening of vaccine. Today area is slightly itchy but not painful. No pain in shoulder joint. No N/V, no other areas of redness or rash, no difficulties breathing. Reports reaction like this in past, but not every year. Presented today for evaluation. Injection site reaction measuring 11cm  x 9.5cm pale pink in color, slightly warmer to touch than surrounding skin, mild swelling noted. No induration. Lt shoulder with full ROM and strength.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Fall, Loss of consciousness, Urinary incontinence
Clinical narrative: 15 minutes after receiving vaccine, nurse was summoned to hallway by group leader in reception, who was informed by another donor that a lady had lost consciousness and fell. Donor reports that she did not hit her head and no injuries noted. Donor that witness accident reported that loss of consciousness was less than 10 seconds. Nurse noted that donor was incontinent of urine. Donor assisted to office where down laid down on exam table, was fanned and a cold compress applied to donor's chest. After 3 minutes donor reported feeling better.
Age: 15.0
Sex: M
Vaccine: FLU4, HIBV, HPV9, VARCEL
Symptoms: Wrong product administered
Clinical narrative: HiB vaccine was given to patient is error. He was suppose to be given Hep. B vaccine. Medical assistant selected the incorrect vaccine and it was given to the patient.
Age: 71.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Erythema, Induration, Oedema, Swelling
Clinical narrative: Had influenza and pneumococcal vaccine both in left deltoid. 24 hours later developed circumferential swelling, erythema, induration. Improved significantly but still mild edema and erythema present upon exam.
Age: 85.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Rash
Clinical narrative: Patient's significant other states that on 10/17/18 patient developed a rash that made his right earlobe red and made a line from his earlobe to cheek bone. Patient's significant other stated he put POLYSPORIN on it. RPh recommended Hydrocortisone cream (pt used 0.5%) and cool cloth. On 10/18, patient & significant other stopped by the pharmacy and stated rash had mostly resolved (appeared clear per observation) and that hydrocortisone cream had helped and patient would continue that for a few days.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient was given an expired dose of MMRV. There were no noted adverse reactions. Reported to Merck, they advised that the vaccine was supported but Immunization Coalition recommends revaccination.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Bursitis
Clinical narrative: PT HAS BEEN TREATED FOR BURSITIS BY A DOCTOR AND HAS HAD 2 ROUNDS OF STEROIDS.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient was given the vaccine about 1:30 pm on 10/17/18 and she said that evening of the same day her arm began to swell around the site of the injection and become hot or warm and hurt.  The patient applied cold packs and the swelling moved down her arm and into her back. On 10/19/18 the patient called the pharmacy and came by. I called her doctor and recommended that she go to the doctor for a visit. The doctor prescribed prednisone and doxycycline for the patient.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Musculoskeletal pain, Neck pain, Pain in extremity
Clinical narrative: Severe pain in arm, shoulder, neck and back.
Age: 11.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Red, swollen, warm to touch.
Age: 71.0
Sex: F
Vaccine: FLU4
Symptoms: Rash, Rash papular
Clinical narrative: Very mild papular rash upper torso and scalp. No other complaints. Began 10 hours after injection. No other changes in household or dietary anomalies. She was in no distress.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Erythema, Pain in extremity
Clinical narrative: Painful, redness, elevated - patient went to md and was diagonsed as having cellulitis.
Age: 1.0
Sex: M
Vaccine: FLU4, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Patient had redness and swelling on the right leg which has been reduced since the day of the incident to about 3cm in diameter. Day one patient had a 101 fever but has been afebrile since. The parents of the child were informed to monitor and bring in if swelling continues and that a cool compress may be applied. No labs are needed at the time.
Age: 0.42
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Injection site mass
Clinical narrative: Mass on left thigh still present 3 + months after the PEDARIX (Dtap/HepB/IPV) vaccine was given.
Age: 10.0
Sex: M
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Hives started on face yesterday 10/18/18; Spread to rest of body on 10/19/18.
Age: 64.0
Sex: F
Vaccine: PNC13, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Pt has had no history of receiving PCV13 or Tdap. Pt receive vaccine on 10/12/2018 denies any reaction until 10/18/2018 saw provider complaining of heat, pain and redness at both injection sites. Pt denies shortness of breath or hives since injection. Pt states does apply BIOFREEZE to arms daily.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injection site bruising, Injection site swelling, Rash macular, Skin warm
Clinical narrative: Patient says: "As soon as the person gave me the shot at pharmacy she said it was beginning to swell and that I should massage the area. Patient did that for a while and a few days later noticed big red splotches on the arm, lower down from where the shot was given. Blotches were several inches long and wide. All the red splotches were very hot to touch and lasted several days. There was also a dark bruise about 1.5 inches in diameter at the injection site."
Age: 59.0
Sex: F
Vaccine: HEP
Symptoms: Fatigue, Headache, Ocular hyperaemia, Photophobia
Clinical narrative: Woke up the next morning feeling tired, constant headache, light sensitivity, both eyes are very red.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site bruising, Injection site pain, Injection site swelling
Clinical narrative: Adverse Event: patient had swelling, bruising and pain at injection site. Treatment: patient periodically applied cold compress. Outcome: patient's swelling and bruising has gotten better and most of pain is gone.
Age: 68.0
Sex: F
Vaccine: FLU4, PPV, FLU3
Symptoms: Bone pain, Hypoaesthesia, Injected limb mobility decreased
Clinical narrative: Pt experienced left arm numbness and inability to abduct left arm, pain into collbarbone area.
Age: 68.0
Sex: F
Vaccine: FLU4, PPV, FLU3
Symptoms: Burning sensation, Electromyogram abnormal, Injection site pain, Injection site swelling, Mobility decreased
Clinical narrative: Pt experienced left arm numbness and inability to abduct left arm, pain into collbarbone area.
Age: 68.0
Sex: F
Vaccine: FLU4, PPV, FLU3
Symptoms: Pain in extremity, Paraesthesia, Radial nerve injury, Wrong technique in product usage process
Clinical narrative: Pt experienced left arm numbness and inability to abduct left arm, pain into collbarbone area.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain, Back pain, Chest pain, Cough, Decreased appetite
Clinical narrative: Fever, severe cough, abdominal pain, chest pains, pain in muscles, pain in back, productive cough, nausea, no appetite. Started on Benzonatate 100 mg. three times a day and LEVAQUIN 500 mg once a day for 7 days by Dr. I was in bed and could hardly get up for over a week. Severe chest pains kept me awake. It was hard to breathe, as well.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Myalgia, Nausea, Productive cough, Pyrexia
Clinical narrative: Fever, severe cough, abdominal pain, chest pains, pain in muscles, pain in back, productive cough, nausea, no appetite. Started on Benzonatate 100 mg. three times a day and LEVAQUIN 500 mg once a day for 7 days by Dr. I was in bed and could hardly get up for over a week. Severe chest pains kept me awake. It was hard to breathe, as well.
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema
Clinical narrative: Red arm at injection site, no treatment was given.
Age: 29.0
Sex: F
Vaccine: FLU4
Symptoms: Contusion, Erythema, Swelling, Tenderness
Clinical narrative: 3inch by 3inch circle of swelling, redness, tenderness, and bruising.
Age: 6.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Headache, Local reaction, Pain in extremity, Pruritus
Clinical narrative: Pt developed very large local reaction 14x 14 cm large erythematous, painfull, pruritic, whole left arm involved. No joint involvement & no systemic findings except for headache.
Age: 6.0
Sex: M
Vaccine: FLU4
Symptoms: Pulmonary function test normal
Clinical narrative: Pt developed very large local reaction 14x 14 cm large erythematous, painfull, pruritic, whole left arm involved. No joint involvement & no systemic findings except for headache.
Age: 39.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Condition aggravated, Diarrhoea, Fatigue, Headache, Pain
Clinical narrative: Patient states started having diarrhea 10/15/18 in the morning. Had Tdap and Flu vaccinations in the afternoon. States diarrhea continued to get worse. Patient states 10/16/18 during the day began feeling achy, and right arm was sore. States in the evening was having body aches, pain, feeling tired, and temperature of 102.6. 10/17/18 called clinic to notify of symptoms, stated fever broke early am, continuing with watery diarrhea, and bad headache. Encouraged to drink plenty of water, and stay well hydrated. Spoke with patient 10/18/18 to follow up stated did run fever night of 10/17/18 of 102.3, but feeling better. Stated had taken Tylenol, was eating yogurt, drinking powerade, and a lot of grape and cranberry juice. Encouraged to avoid drinking juice with diarrhea. 10/19/18 Spoke with patient this afternoon states feeling fine today, a lot better than yesterday.
Age: 39.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Patient states started having diarrhea 10/15/18 in the morning. Had Tdap and Flu vaccinations in the afternoon. States diarrhea continued to get worse. Patient states 10/16/18 during the day began feeling achy, and right arm was sore. States in the evening was having body aches, pain, feeling tired, and temperature of 102.6. 10/17/18 called clinic to notify of symptoms, stated fever broke early am, continuing with watery diarrhea, and bad headache. Encouraged to drink plenty of water, and stay well hydrated. Spoke with patient 10/18/18 to follow up stated did run fever night of 10/17/18 of 102.3, but feeling better. Stated had taken Tylenol, was eating yogurt, drinking powerade, and a lot of grape and cranberry juice. Encouraged to avoid drinking juice with diarrhea. 10/19/18 Spoke with patient this afternoon states feeling fine today, a lot better than yesterday.
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema
Clinical narrative: Red arm at the injection site, no treatment was given.
Age: 27.0
Sex: M
Vaccine: FLUC4
Symptoms: Anal incontinence, Blood glucose normal, Computerised tomogram, Condition aggravated, Hyperhidrosis
Clinical narrative: Patient received flu vaccine, seizure activity noted within 5 minutes of receipt with loss of bladder and bowel control. Patient diaphoretic, pale with B/P of 90/58. Seizure activity noted for short periods of time (seconds) twice after initial seizure. Patient postictal transferred by ambulance to local hospital where he received fluid and a CT scan. He was released home the same day and ordered to restart seizure medication. (Patient had a history of seizure disorder but had not had a seizure in 10 years, patient was not on seizure medication.) He will follow-up with clinic.
Age: 27.0
Sex: M
Vaccine: FLUC4
Symptoms: Pallor, Postictal state, Seizure, Urinary incontinence
Clinical narrative: Patient received flu vaccine, seizure activity noted within 5 minutes of receipt with loss of bladder and bowel control. Patient diaphoretic, pale with B/P of 90/58. Seizure activity noted for short periods of time (seconds) twice after initial seizure. Patient postictal transferred by ambulance to local hospital where he received fluid and a CT scan. He was released home the same day and ordered to restart seizure medication. (Patient had a history of seizure disorder but had not had a seizure in 10 years, patient was not on seizure medication.) He will follow-up with clinic.
Age: 11.0
Sex: F
Vaccine: FLU4
Symptoms: Muscular weakness, Myelitis, Nuclear magnetic resonance imaging brain, Nuclear magnetic resonance imaging spinal
Clinical narrative: Diagnosis of acute flaccid myelitis, Hx improvement RUE symptoms, followed by clinical worsening post influenza vaccine with new onset lower extremity weakness.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 05-SEP-2017, the patient was vaccinated with a dose of GARDASIL 9 (strength and route were unknown) (lot# M040412 and expiration date 30-JUN-2019). On 15-NOV-2017 and 05-SEP-2018, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (strength and route were unknown) (lot# N019923 and expiration date 30-JUN-2019; lot# N032956 and expiration date 13-JUL-2020) for prophylaxis (Incorrect product storage), respectively. No adverse event was reported. The excursion temperature on 08-NOV-2017, 16-NOV-2017, 23-JAN-2018, 06-JUN-2018, 03-JUL-2018 and 14-AUG-2018 was 47 degree Celsius for maximize 15 hours. The excursion temperature on 07-DEC-2017 was 50 degree Celsius for maximize 8.75 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1810USA001951; US-009507513-1810USA001952; US-009507513-1810USA001953; US-009507513-1810USA001954; US-009507513-1810USA001955; US-009507513-1810USA001957; US-009507513-1810USA001958; US-009507513-1810USA001959; US-009507513-1809USA003709.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2012, the patient was inoculated with ZOSTAVAX at a physician's office (and administered by a physician) as recommended for routine adult health maintenance and for the long-term prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster or shingles. In 2015, the patient was treated by the same physician at the office for the onset of a severe vesicular rash which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain, Peripheral swelling, Skin warm
Clinical narrative: This spontaneous report was received from a 67-year-old female patient who was reporting on herself. The patient had no pertinent medical history. The patient had an allergy to penicillin. She received trazodone hydrochloride, propranolol and pantoprazole as concomitant medications. On 03-OCT-2018, the patient was vaccinated with PNEUMOVAX23, one injection, route of administration was reported as injection (dose, lot# and expiration date were not reported), to prevent pneumonia. On the same day, the patient experienced redness, swelling and a hot feeling in her arm and body aches for several days after injection. The patient seek medical attention. No treatment for the events was given and no lab diagnostic studies were performed. The outcome of injection site redness, swelling and hot feeling in her arm and body aches was reported as recovered/resolved on an unknown date in October 2018. The relatedness between the events and PNEUMOVAX23 was not reported.
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site pain, Injection site reaction, Musculoskeletal stiffness
Clinical narrative: Information has been received from a physician assistant concerning to a 67 year old female patient who had allergy to codeine, lisinopril (manufacturer unknown) and indomethacin. On 10-OCT-2018, the patient was vaccinated with a dose of PNEUMOVAX 23, intramuscular in the left arm (dose, lot number and expiration date not reported) for prophylaxis. The same day, in the right arm the patient was vaccinated with a dose of influenza virus vaccine (manufacturer, dose, lot number and expiration date not reported). On 10-OCT-2018, the patient started to experience stiffness of the right shoulder with pain. The patient sought medical attention. No lab diagnostics were performed. No hospitalization, overdose, cancer nor death were reported. At the time of the report the patient was recovering from 1 day joint stiffness and musculoskeletal pain. The relationship between musculoskeletal pain, joint stiffness, PNEUMOVAX 23 and influenza virus vaccine. This is one of two reports from the same patient. Sender's Comments: US-009507513-1810USA008498.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On an unknown date in 2010, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. On an unknown date in 2013, the patient was treated in the center for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient had suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 12-NOV-2014, the patient was inoculated with ZOSTAVAX by a physician as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 14-NOV-2015, the patient was treated the same physician for a blistering vesicular outbreak which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age.  No information was provided regarding concomitant medications, concurrent conditions or medical history. On an unknown date in 2015, the patient was inoculated with ZOSTAVAX as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster or shingles. On an unknown date in 2017, the patient was treated in hospital for a blistering vesicular outbreak which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 2013, the patient was inoculated with ZOSTAVAX by a physician as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 2014, the patient was treated the same physician for a blistering vesicular outbreak which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages.  The outcome of the events was unknown. Causality assessment was related.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Post herpetic neuralgia, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 08-JUN-2012, the patient was inoculated with ZOSTAVAX from a pharmacy as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster and post herpetic neuralgia, a chronic condition of pain and nerve damage secondary to herpes zoster infections. On or about 17-DEC-2013, the patient was treated for a blistering vesicular outbreak which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, was prescribed Gabapentin for management of her painful symptoms and chronic pain and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On an unknown date in 2015, the patient was inoculated with ZOSTAVAX as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster or shingles. On an unknown date in 2016, the patient was treated by a physician for a blistering vesicular outbreak which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient had suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of events was unknown. Causality assessment was related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Ophthalmic herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was provided regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 31-JUL-2012, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 16-OCT-2016, the patient was treated at an urgent care facility (by unspecified healthcare professional) for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. On or about 17-OCT-2016, the patient was treated at an eyecare facility by the ophthalmologist/MD, for a blistering vesicular outbreak, which was diagnosed as ocular shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Upon internal review, the event of blistering vesicular outbreak, which was diagnosed as ocular shingles was determined to be medically significant. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On an unknown date in 2010, the patient was inoculated with ZOSTAVAX as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster or shingles. On an unknown date in 2016, the patient was treated in the same hospital for a blistering vesicular outbreak which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 03-SEP-2014, the patient was inoculated with ZOSTAVAX as recommended for routine adult health maintenance for the long-term prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster or shingles. In 2014, the patient was treated for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 29-OCT-2010, the patient was inoculated with ZOSTAVAX as recommended for routine adult health maintenance for the long-term prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. On an unknown date (reported as on or about 27-SEP-2010), the patient was treated for shingles. The patient was prescribed Valtrex for management of his painful symptoms and chronic pain. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On an unknown date in 2013, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. Later on an unknown date in 2013, the patient was treated for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient had suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Death, Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On an unknown date in 2015, the patient was inoculated with ZOSTAVAX by a physician as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. On an unknown date in 2016, the patient was treated in the center for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient had suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. On 18-JAN-2018, the patient passed away. Cause of death was unknown. It was unknown if autopsy was performed. Outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 09-JAN-2013, the patient was inoculated with ZOSTAVAX as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 2014, the patient was treated for a blistering vesicular outbreak which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On an unknown date in 2012, the patient was inoculated with ZOSTAVAX as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster or shingles. On an unknown date in 2014, the patient was treated by a physician for a blistering vesicular outbreak which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2008, the patient was inoculated with ZOSTAVAX as recommended for routine adult health maintenance for the long-term prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster or shingles. Later in 2008, the patient was treated for the onset of severe vesicular rash which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2014, the patient was inoculated with ZOSTAVAX as recommended for routine adult health maintenance for the long-term prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster or shingles. Later in 2014, the patient was treated for the onset of severe vesicular rash which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On an unknown date in 2014, the patient was inoculated with ZOSTAVAX as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. On an unknown date in 2016, the patient was treated for the onset of a severe vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient had suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Outcome of the events was unknown. Causality assessment was related. Additional information has been requested.