chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.5
Sex: M
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse referring to several patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patients were inadvertently vaccinated with an improperly stored doses of ROTATEQ orally, for prophylaxis (dose and frequency were not provided) (lot number: N030152, expiration date: 01-SEP-2019). The administered doses of the vaccine experienced a temperature of 9 degrees Celsius (°C) to 25 degrees Celsius (°C) during a time frame of 13 hours and 36 minutes, as recorded by a data logger. There was no adverse effect reported and no product quality complaint was involved. Follow up information was received from the registered nurse on 05-NOV-2018, referring to a male patient of 6 months old. On 20-AUG-2018, the patient was inadvertently vaccinated with an improperly stored dose of ROTATEQ. This case was previously considered Non-valid, but upon follow up it was determined to be valid.
Age: 14.0
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: This spontaneous report has been received from a medical assistant referring to a currently unknown age patient of unknown gender. Information about concomitant medication, pertinent medical history and drug reactions/allergies was not provided. On an unknown date (when the patient was 12 years old), the patient was vaccinated with the first dose of GARDASIL 9 for prophylaxis (strength, route, batch/lot #, and expiration date were not reported). On an unknown date (when the patient was 14 years old), the patient was vaccinated with the second dose of vaccine GARDASIL 9 (strength, route, batch/lot #, and expiration date were not reported). No adverse effects were reported.
Age: 16.0
Sex: F
Vaccine: FLUX, HPV9, MNQ
Symptoms: Extra dose administered, No adverse event, Wrong product administered
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 16-year-old female patient. The patient's medical history included anxiety, keratosis pilaris (KP), hyperbilirubinaemia and (R) facial / buccal cellulitis. The patient's concurrent conditions included penicillin G sodium and AUGMENTIN allergy. The patient did not have illness at time of vaccination. The patient's historical condition included attention deficit/hyperactivity disorder (ADHD), Schamberg disease, labial hypertrophy and obstructive sleep apnea (OSA). The patient's historical vaccination included diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid, Hib conj vaccine (unspecified), poliovirus vaccine inactivated (unspecified), M-M-R, hepatitis B virus vaccine (unspecified), varicella virus vaccine live (unspecified), hepatitis A virus vaccine (unspecified), influenza virus vaccine (unspecified), pneumococcal conj vaccine (unspecified), meningococcal conj vaccine (unspecified), seasonal influenza vaccine (unspecified) and influenza virus A vaccine (unspecified) (H1N1). The patient did not have illness at time of vaccination. No patient's concomitant therapies was provided. On 18-SEP-2013, the patient was vaccinated with the first dose of GARDASIL 9 and the first dose of MENACTRA (dose, frequency, route of administration, lot # and expiration date were not reported). On 18-NOV-2013, the patient was vaccinated with the second dose of GARDASIL 9. On 22-APR-2014, the patient was vaccinated with the third dose of GARDASIL 9, (dose, route of administration, lot # and expiration date were not reported for this three doses). On 05-OCT-2018, the patient presented to the office for immunisation only visit. On the same day, the patient was vaccinated with fourth dose of GARDASIL 9 intramuscularly in right vastus lateralis, lot # R008163 with expiration date 18-NOV-2020 (dose was not reported) instead of MENACTRA (dose, route of administration, lot# and expiration date were not reported). On the same day, the patient was vaccinated with MENACTRA and flu vaccine (unspecified). No ill effect noted post-administration. No prescription drug treatment was required.
Age: 8.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Information has been received from a medical assistant referring to a 8 year old patient of unknown gender. Information about concomitant medication, pertinent medical history and drug reaction were not provided. On 19-OCT-2018 the patient was inadvertently vaccinated with GARDASIL 9 intramuscularly for prophylaxis (lot #: N035957,Expriation date: 10-OCT-2020; dose was not reported. No adverse effect has been reported.
Sex: U
Vaccine: FLUX, PPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's relevant medical history, concurrent conditions and concomitant medications were unknown. On 25-OCT-2018, the patient was vaccinated with a dose of PNEUMOVAX 23 for prophylaxis, lot # R012550 and expiration date 25-JAN-2020 (dose, strength, frequency, and route of administration were unknown). On the same date, the patient went to the pharmacy and received a dose of influenza virus vaccine (unspecified)(manufacturer unknown)for prophylaxis (dose, strength, frequency, route of administration, lot# and expiration date were unknown); and a second dose (overdose) of PNEUMOVAX 23 for prophylaxis (dose, strength, frequency, route of administration, lot# and expiration date were unknown). No adverse effects were reported.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a 60 year old patient of unknown gender. Concomitant therapy included sterile diluent (MERCK) (lot# M039641 with expiration date 16-JAN-2019). Information about concurrent condition, drug reactions/allergies and medical history was not provided. On 25-OCT-2018, the patient was inadvertently received a dose of ZOSTAVAX (subcutaneous, lot # N020938, strength was not reported) for prophylaxis which expired on 31-JUL-2018. No adverse effects were reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On 25-OCT-2018, the patient received a dose of improperly stored VARIVAX (lot # N029628, expiration date: 23-OCT-2019) (strength, dose, route and frequency were not provided) for prophylaxis. The sterile diluent stored properly in the refrigerator. No adverse effects were reported. The VARIVAX vaccine was exposed to a temperature excursion of 6 Fahrenheit (F) degrees to 14 F (11 F) for 1 hours and 9 minutes. The previous excursions was 6 F to 14 F for 49 hours and 16 minutes and 15 F to 46 F for 39 hours and 57 minutes. A digital data logger was involved.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Death, Haematemesis
Clinical narrative: This initial spontaneous report was received from a registered nurse via company representative, concerning a 2 month old male patient. The patient did not have pertinent medical history or drug reactions or allergies. The patient's concomitant therapies included PEDIARIX, hib conj vaccine (unspecified), PREVNAR 13 and unspecified "2 month shots". On 25-OCT-2018, the patient was vaccinated with ROTATEQ, orally for "vaccination" (dose, strength and lot number were not reported). On 28-OCT-2018, the patient threw up blood (haematemesis), therefore, he was taken to an unspecified hospital and died on the same date. No laboratory test or studies were taken, moreover, it was unknown if an autopsy was performed. No product quality complaint (PQC) was reported. At the reporting time, the action taken was assessed as not applicable. The reporter did not provide a causality assessment for the event haematemesis. Upon internal review, the event haematemesis leading to death was determined to be medically significant. Reported Cause(s) of Death: The patient threw up blood.
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Herpes zoster, Pain, Rash
Clinical narrative: Information has been received from a 77 year old female consumer with no allergies and no pertinent medical history, who in August 2011 was administered the ZOSTAVAX "one shot once" (lot number and route of administration not provided) as a vaccination against shingles. Concomitant medications included: atorvastatin, levothyroxine, and citalopram. In approximately 2011 (reported as "a few months after she got the vaccination"), she got the shingles. The patient called her doctor when she woke up with the rash and the physician told her he needed to see her immediately. The patient stated she assumed the physician did a test and did not just look at her and say she had shingles, but she didn't remember what tests were done (no results were provided). She was prescribed gabapentin (four 300 mg pills every 4 hours). The patient has continued therapy with gabapentin and stated that if she doesn't take the gabapentin, "my whole body starts to scream." The patient stated she was miserable and in constant pain. The outcome of the shingles was reported as not recovered. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash, Skin lesion
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 20-MAR-2015, the patient received the ZOSTAVAX (lot number, dosage and route of administration not provided) for its intended purpose: the prevention of shingles. As a direct result of the ZOSTAVAX, the patient suffered from a shingles outbreak, in addition to chronic pain, rash and lesions to various parts of her body. The patient's shingles outbreak was diagnosed on 01-SEP-2015. As a direct result of the ZOSTAVAX, the patient suffered mental and emotional distress due to and continues with physical limitations and seriousness of her condition. The patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The patient has incurred medical expenses and other economic harm as a direct result of use her use of  ZOSTAVAX. Shingles outbreak was considered to be disabling. Additional information has been requested.
Age: 17.0
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, Wrong product administered
Clinical narrative: PATIENT WAS TO RECEIVE MEN B VACCINE AND THERE WAS A LOT OF DISCUSSION WITH MOTHER ABOUT PATIENTS HPV SERIES WHICH NUMBER 3 IS NOT DUE UNTIL FEB 24TH. IN ERROR HPV WAS GIVEN INSTEAD OF MEN B.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Bed rest, Chills, Headache, Nausea, Pain
Clinical narrative: Chills, fever, nausea, body aches, headache, all severe. Treated with bed rest and hydration. Symptoms began to subside after about 18 hours.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Chills, fever, nausea, body aches, headache, all severe. Treated with bed rest and hydration. Symptoms began to subside after about 18 hours.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Hyperhidrosis, Mobility decreased, Musculoskeletal stiffness, Pyrexia, Tremor
Clinical narrative: 11/7 7:00pm- "severe arm stiffness-could not move her arm at all" per patient. 11/7 10:30pm- "severe tremors-needed help up the stairs" per patient. 11/8 12:30am- "drenched in sweat- fever of 100.3" per patient. Morning of 11/8- "called md to report fever- fever had gone down to 100.1- md told patient to take TYLENOL for fever and come to the office if fever persisted or got worse" per patient.
Age: 75.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Chest X-ray abnormal, Chills, Malaise, Pain, Pneumonia
Clinical narrative: 24 hours post vaccines began to feel unwell. Fever chills, body aches -> Put on TAMIFLU with minimal improvement (by primary) Nov.2 - put on Doxycycline and chest XRay revealed pneumonia (by primary).
Age: 75.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Pyrexia
Clinical narrative: 24 hours post vaccines began to feel unwell. Fever chills, body aches -> Put on TAMIFLU with minimal improvement (by primary) Nov.2 - put on Doxycycline and chest XRay revealed pneumonia (by primary).
Age: 55.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Chest X-ray, Chills, Cough, Dyspnoea
Clinical narrative: Had the vaccine October 22 in my left arm. That day, the site stayed swollen and painful. The next day, October 23rd, I was feeling weak, temperature 102.4, chills and generalized malaise. The fever lasted 2 days. The injection site was getting more swollen, painful and reddened for more than a week. I had a skin reaction in the side of my right calf simultaneously as my arm was having the reaction. I did show my calf to a doctor and a nurse practitioner at work. I was also coughing a lot. I went back to the doctor on November 1st since my arm was still swollen, itchy and painful. Dr ordered prednisone and BACTRIM. As I was taking the medications for allergies, I developed breathing symptoms, lots of wheezes rhonchi which forced me to go to the doctor again. The skin of the injection site is presently peeling off. Please follow up on my complaints to get the manufacturer and lot number for the vaccine that I was given. Thanks.
Age: 55.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling, Malaise
Clinical narrative: Had the vaccine October 22 in my left arm. That day, the site stayed swollen and painful. The next day, October 23rd, I was feeling weak, temperature 102.4, chills and generalized malaise. The fever lasted 2 days. The injection site was getting more swollen, painful and reddened for more than a week. I had a skin reaction in the side of my right calf simultaneously as my arm was having the reaction. I did show my calf to a doctor and a nurse practitioner at work. I was also coughing a lot. I went back to the doctor on November 1st since my arm was still swollen, itchy and painful. Dr ordered prednisone and BACTRIM. As I was taking the medications for allergies, I developed breathing symptoms, lots of wheezes rhonchi which forced me to go to the doctor again. The skin of the injection site is presently peeling off. Please follow up on my complaints to get the manufacturer and lot number for the vaccine that I was given. Thanks.
Age: 55.0
Sex: F
Vaccine: PPV
Symptoms: Pruritus, Pyrexia, Skin exfoliation, Skin reaction, Wheezing
Clinical narrative: Had the vaccine October 22 in my left arm. That day, the site stayed swollen and painful. The next day, October 23rd, I was feeling weak, temperature 102.4, chills and generalized malaise. The fever lasted 2 days. The injection site was getting more swollen, painful and reddened for more than a week. I had a skin reaction in the side of my right calf simultaneously as my arm was having the reaction. I did show my calf to a doctor and a nurse practitioner at work. I was also coughing a lot. I went back to the doctor on November 1st since my arm was still swollen, itchy and painful. Dr ordered prednisone and BACTRIM. As I was taking the medications for allergies, I developed breathing symptoms, lots of wheezes rhonchi which forced me to go to the doctor again. The skin of the injection site is presently peeling off. Please follow up on my complaints to get the manufacturer and lot number for the vaccine that I was given. Thanks.
Age: 52.0
Sex: M
Vaccine: FLU4
Symptoms: Dizziness, Headache, Nausea, Pain, Pyrexia
Clinical narrative: Body aches began 7 hours after flu shot. Dizziness and slight nausea as well. Fever began 9 hours after flu shot. Still experiencing headache following morning (now) at 10 am.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Blister, Pruritus, Rash
Clinical narrative: Pt said about 10-13 days after she received the HD flu vaccine she had a small rash with some small blister on her right wrist,thumb nail on right hand, left thigh and left arm. Called to HD 11/7/2018 to report this and ask if it was related to the HD flu. She also reported working outside in the grass. Said she has been using hydrocortisone and calamine lotion for the itching. Enc pt to seek care of her PMD if needed.
Age: 83.0
Sex: M
Vaccine: FLU3
Symptoms: Bursitis, Injection site pain, Injection site reaction
Clinical narrative: Left shoulder bursitis and pain Recommended ice and movement, topical pain creme, if not better in a week from visit may consider steriod injection or orthopedic consult.
Age: 73.0
Sex: F
Vaccine: HEPA, PPV
Symptoms: Breast pain, Erythema, Injected limb mobility decreased, Injection site erythema, Injection site swelling
Clinical narrative: Red and swelling at the injection site on her right arm that caused arm immobility. Redness and pain continued to move down the arm to patients wrist and has since extended to her breasts as well. Went to the doctor on 11/6 and started on Benadryl and ibuprofen as well as cold compresses. Since that time she has had slight improvement but is still in a lot of pain.
Age: 73.0
Sex: F
Vaccine: HEPA, PPV
Symptoms: Pain in extremity
Clinical narrative: Red and swelling at the injection site on her right arm that caused arm immobility. Redness and pain continued to move down the arm to patients wrist and has since extended to her breasts as well. Went to the doctor on 11/6 and started on Benadryl and ibuprofen as well as cold compresses. Since that time she has had slight improvement but is still in a lot of pain.
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Axillary vein thrombosis, Injection site swelling, Peripheral coldness, Peripheral swelling, Skin discolouration
Clinical narrative: Thrombus of the right axillary vein extending into the proximal aspect of the more superficially positioned brachial vein. Swelling of right upper extremity (primary encounter diagnosis) Note: s/p flu shot 10/31/18. Unusual appearing reaction. Does not appear cellulitic. Check RUE venous ultrasound. She will complete the course of prednisone already prescribed by sister-in-law doctor- day 3/5 of prednisone 40 mg daily. Knows to call and/or go to an ER if she develops any numbness, tingling, paresthesias or weakness in her arm. Friday night (2 days after flu shot) noticed right bicep swollen with swelling extended into the lower arm and hand. Saturday noticed color change in her arm/hand- bluish/red, a/w the swelling No numbness or tingling. RUE feels tight. Hand feels colder to her. Has full strength in arm. The more she uses her arm the more it swells.
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Skin tightness, Ultrasound scan, Vaccination complication
Clinical narrative: Thrombus of the right axillary vein extending into the proximal aspect of the more superficially positioned brachial vein. Swelling of right upper extremity (primary encounter diagnosis) Note: s/p flu shot 10/31/18. Unusual appearing reaction. Does not appear cellulitic. Check RUE venous ultrasound. She will complete the course of prednisone already prescribed by sister-in-law doctor- day 3/5 of prednisone 40 mg daily. Knows to call and/or go to an ER if she develops any numbness, tingling, paresthesias or weakness in her arm. Friday night (2 days after flu shot) noticed right bicep swollen with swelling extended into the lower arm and hand. Saturday noticed color change in her arm/hand- bluish/red, a/w the swelling No numbness or tingling. RUE feels tight. Hand feels colder to her. Has full strength in arm. The more she uses her arm the more it swells.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Anal incontinence, Arthralgia, Asthenia, Chills, Cough
Clinical narrative: Severe weakness, chills, loose stool, cough. Symptoms started shortly after the vaccine was given. Mild cough  at first. As the day progressed the cough continued and fatigue started to be present. The next day cough stayed the same with more fatigue and some nasal drainage. The third day weakness, lightheadedness to the point of almost passing out, uncontrolled bowels with watery stool, chills and sweats. Cough continued, although no sore throat. The third day and fourth there was pain in the area that had been previously fractured. My left foot and left wrist. Also my hips were achy, more on the top of the pelvis instead of the joint.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Depressed level of consciousness, Diarrhoea, Dizziness, Fatigue, Hyperhidrosis
Clinical narrative: Severe weakness, chills, loose stool, cough. Symptoms started shortly after the vaccine was given. Mild cough  at first. As the day progressed the cough continued and fatigue started to be present. The next day cough stayed the same with more fatigue and some nasal drainage. The third day weakness, lightheadedness to the point of almost passing out, uncontrolled bowels with watery stool, chills and sweats. Cough continued, although no sore throat. The third day and fourth there was pain in the area that had been previously fractured. My left foot and left wrist. Also my hips were achy, more on the top of the pelvis instead of the joint.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Rhinorrhoea
Clinical narrative: Severe weakness, chills, loose stool, cough. Symptoms started shortly after the vaccine was given. Mild cough  at first. As the day progressed the cough continued and fatigue started to be present. The next day cough stayed the same with more fatigue and some nasal drainage. The third day weakness, lightheadedness to the point of almost passing out, uncontrolled bowels with watery stool, chills and sweats. Cough continued, although no sore throat. The third day and fourth there was pain in the area that had been previously fractured. My left foot and left wrist. Also my hips were achy, more on the top of the pelvis instead of the joint.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Dry mouth, Feeling hot, Headache
Clinical narrative: Sore arm, chills & shivering at first, then overheating in bed, low grade headache, low grade muscle aches throughout body, mouth dryness, lack of energy; feels like onset on mild flu.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Myalgia, Pain in extremity
Clinical narrative: Sore arm, chills & shivering at first, then overheating in bed, low grade headache, low grade muscle aches throughout body, mouth dryness, lack of energy; feels like onset on mild flu.
Age: 43.0
Sex: F
Vaccine: FLUX
Symptoms: Musculoskeletal discomfort, Pain
Clinical narrative: Pt is a healthcare provider, was given seasonal influenza vaccine by workplace employee health, subsequently developed discomfort in the shoulder (particularly abduction above 80-90 deg) unrelieved by OTC analgesics, ice, and rest as recommended by myself (occupational med and workcomp provider) on 10/22 when she initially presented for evaluation. Currently has initiated physical therapy.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pain in extremity
Clinical narrative: Left arm pain that radiates down worsens at night described as an "achy" pain.
Age: 11.0
Sex: M
Vaccine: FLU4, TDAP
Symptoms: Erythema, Tenderness
Clinical narrative: Right arm- red circular area 3.5cm in diameter tender to touch. Mother reports area has not spread.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: Flu like symptoms that lasted 2 days. Affected arm that had surgery. Rest and ADVIL for treatment. Outcome was extended pt by 2 weeks.
Age: 1.33
Sex: M
Vaccine: HIBV, PNC13
Symptoms: Erythema, Feeling hot, Pain, Swelling, Vomiting
Clinical narrative: Mom reported pain, swelling, warmth, redness approximately silver dollar size yesterday and one episode of emesis overnight.
Age: 27.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Diarrhoea, Dizziness, Headache, Influenza virus test negative, Nausea
Clinical narrative: The evening after the shot I began to have soreness in my neck and throat and have a head ache. My left arm was sore. The next day I had vomiting, diahrea, and dizziness. My arm is sore and swollen and has read sploches.
Age: 27.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Neck pain, Oropharyngeal pain, Pain in extremity, Peripheral swelling, Rash macular
Clinical narrative: The evening after the shot I began to have soreness in my neck and throat and have a head ache. My left arm was sore. The next day I had vomiting, diahrea, and dizziness. My arm is sore and swollen and has read sploches.
Age: 27.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Vomiting
Clinical narrative: The evening after the shot I began to have soreness in my neck and throat and have a head ache. My left arm was sore. The next day I had vomiting, diahrea, and dizziness. My arm is sore and swollen and has read sploches.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Disturbance in attention, Fatigue, Headache
Clinical narrative: Headache, chills, weakness, Extremely sore left arm, muscle aches throughout the rest of the body, fatigue, lack of concentration began on 11/6/2018 at approximately 6 pm and continued to 11/8/2018 at approximately 8 am or sometime during the evening while sleeping. I still feel some weakness this morning and some muscle pain and a very slight headache, but I will be able to go to work today which was impossible yesterday.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Impaired work ability, Myalgia, Pain in extremity
Clinical narrative: Headache, chills, weakness, Extremely sore left arm, muscle aches throughout the rest of the body, fatigue, lack of concentration began on 11/6/2018 at approximately 6 pm and continued to 11/8/2018 at approximately 8 am or sometime during the evening while sleeping. I still feel some weakness this morning and some muscle pain and a very slight headache, but I will be able to go to work today which was impossible yesterday.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a patient of unknown age and gender. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider (unspecified healthcare professional), recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 2011, a pharmacist at a pharmacy administered the ZOSTAVAX (lot number, dosage and route of administration not provided) to the patient. On or about 03-DEC-2016, the patient was treated by a registered nurse/RN at a health care facility for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death; aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Age: 52.0
Sex: M
Vaccine: SMALL
Symptoms: Injection site scab, Post vaccination autoinoculation, Skin laceration
Clinical narrative: On 24Oct2018, a report was received from a Study. Patient is a 52 year old male with history of allergy to penicillin and pork who was vaccinated with ACAM2000 (LotVV03-013-C) on 06OCT2018 at 16:35 hr. No concomitant medications were reported. On 24OCT2018, the subject presented to the clinic with an secondary scab (autoinoculation) near his original vaccination site, and was similar in size. The secondary scab started on 17OCT2018 and on 24OCT2018 both sites were in a scabbing stage. The subject stated that the bandage had caused tearing to his skin. It was noted that the subject had two scabs present and was counseled on vaccination site care by the health care provider at the clinic, in addition to being supplied a site care kit. The Principal Investigator considers this as a case of autoinoculation. The case was reported as amild and not serious adverse event that was related to the administration of ACAM2000. Company Medical Assessment: The Company agrees with the Investigator's assessment. For reporting purposes seriousness has been upgraded to serious (medically significant) due to commitment to the FDA.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No symptoms of adverse reaction yet. Patient was given pneumo 23 when she needed 13 to finish the series.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Pt reported to be fine at the time of the event. No further adverse events have been reported by the patient.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Pain, Pain in extremity, X-ray limb
Clinical narrative: Left arm pain, severe, 6/10 pain scale, pain aggravated by movement, pain somewhat better with heat/ice and OTC meds.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site joint pain, Injection site pain, Pain in extremity, Paraesthesia
Clinical narrative: Patient received flu shot at off-site IMZ clinic on 10/24/18. Reports that immunization felt different than other immunizations that she has previously had. Considerably more painful than previous immunizations. Arm was more sore than usual following injection and not just at injection site. Describes a pain that starts in her shoulder joint and tingles throughout her elbow and sometimes into her hand. Pain has been consistent for the past 2 weeks and she has become concerned that this could be something serious. She Googled her symptoms and fears that her discomfort could be from the immunization being administered too high in the arm. She has not sought medical attention, but is wondering if she should.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Skin discolouration
Clinical narrative: Red /pink on torso, front only. Strip across mid torso above belly button and below bra line. Flat, not raised. No blistering, just skin discoloration. Not itching, not painful. Only noticed because dressing in front of a mirror.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site joint pain, Injection site pain, Pain, Pain in extremity
Clinical narrative: Patient received flu shot at off-site IMZ clinic on 10/24/18. Reports that immunization felt different than other immunizations that she has previously had. Considerably more painful than previous immunizations. Arm was more sore than usual following injection and not just at injection site. Describes a pain in her shoulder joint with loss of range of motion. She also has pain when using her arm to pick up light items such as soda bottles. Pain has been consistent for the past 2 weeks and she has become concerned that this could be something serious. She Googled her symptoms and fears that her discomfort could be from the immunization being administered too high in the arm. She has not sought medical attention, but is wondering if she should.
Age: 21.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: Right deltoid pain since receiving the vaccine 3 weeks ago. We started treating her today with naproxen 500mg 1 tablet by mouth twice a day.
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Rash
Clinical narrative: Rash from mid thoracic region up to ears.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia, Muscular weakness, Pain, Paraesthesia
Clinical narrative: 2 weeks post injection, numbness and tingling radiating down (Rt) arm to fingertips which continues to present, with intermittent sharp - burning, pain, muscle weakness. 21/2 weeks post injection, numbness and tingling, radiating down (Rt) leg to toes which continues to present with interment sharp burning pain.
Age: 30.0
Sex: F
Vaccine: UNK
Symptoms: Lymphadenopathy, Rash, Swelling face
Clinical narrative: Swollen glands. Rash on scalp. Facial swelling.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Fatigue, Headache, Injection site pain, Myalgia
Clinical narrative: Headache, generalized aches-muscles, joint pain, fatigue, pain at site of injection.
Age: 53.0
Sex: F
Vaccine: FLUC4
Symptoms: Limb discomfort, Pain
Clinical narrative: Patient states she still has discomfort when raising her arm from waist-high level to shoulder level. She went to her physician who prescribed a 30 day course for NSAID anti-inflammatory.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pain in extremity
Clinical narrative: Soreness of right arm radiating to hand, prescription for NAPROSYN. Pain did not resoce, evaluated by personal physician and referred to hand specialist. He prescribed Meloxicam and has recheck in 2 weeks. He anticipates symptoms will resolve with medication and arm rest.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Burning sensation, Erythema, Joint swelling, Musculoskeletal stiffness, Rash pruritic
Clinical narrative: 11/7/18 - patient reports stiff neck; 11/8/18 - reports she broke out in a rash and still has a stiff neck, rash itches and burns. Also reports having a knee replacement, which is swollen and pink currently. Advise following up with the doctor. Left message with agent at doctor's office.
Age: 93.0
Sex: M
Vaccine: FLUA3
Symptoms: Chills, Nausea, Vomiting
Clinical narrative: Patient's son called and reported chills, nausea and vomiting.
Age: 16.0
Sex: F
Vaccine: HPV9
Symptoms: Depressed level of consciousness, Immediate post-injection reaction, Injected limb mobility decreased, Injection site pain, Pain
Clinical narrative: Mom reports that patient felt pain and nearly passed out immediately after injection on 10/23/18. She recalls the injection was given quite high on the arm near the shoulder joint. On 11/7/18, Mom reports continued right shoulder pain. Painful to touch and motion. Does have a dull ache at rest. Decreased range of motion. No discoloration, swelling or numbness/tingling noted per mom.
Age: 16.0
Sex: F
Vaccine: HPV9
Symptoms: Product administered at inappropriate site
Clinical narrative: Mom reports that patient felt pain and nearly passed out immediately after injection on 10/23/18. She recalls the injection was given quite high on the arm near the shoulder joint. On 11/7/18, Mom reports continued right shoulder pain. Painful to touch and motion. Does have a dull ache at rest. Decreased range of motion. No discoloration, swelling or numbness/tingling noted per mom.
Age: 35.0
Sex: M
Vaccine: FLU4
Symptoms: Dysphagia, Oropharyngeal pain, Paraesthesia
Clinical narrative: Patient received the flu vaccine at approximately 0830 at a shot-ex. Pt reported that at about 0945 his leg started tingling. At about 1345 pt reported that his throat begin to hurt and he was experiencing difficulty swallowing. Pt reported to the emergency room for treatment.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Burning sensation, Dysstasia, Musculoskeletal stiffness
Clinical narrative: Employee reports burning sensation between shoulder blades and bilateral thighs. C/O stiff neck and difficulty standing up from toilet approximately 15 minutes after administration of vaccine.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash generalised
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of generalized rash in a 73-year-old male patient who received SHINGRIX for prophylaxis. On 1st October 2018, the patient received the 1st dose of SHINGRIX. In October 2018, less than a month after receiving SHINGRIX, the patient experienced generalized rash. On an unknown date, the outcome of the generalized rash was not recovered/not resolved. The reporter considered the generalized rash to be related to SHINGRIX. Additional details were provided as follows: The patient experienced rash incident on hands, feet and other parts of the body. At the time of reporting, the patient still had the event after one month. The reporter understood that, the event was related to the product. The reporter agreed to be followed up.
Sex: U
Vaccine: VARZOS
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 19-year-old patient of unknown gender. No information regarding the patient's pertinent medical history, concomitant medications and drug reactions or allergies was provided. On an unknown date in October 2018, the patient was inadvertently vaccinated with a dose of ZOSTAVAX injection (lot number, expiration date, exact dose, anatomical location and route of administration were not provided) reconstituted with sterile diluent (lot number and expiration date were not provided). Product quality complaint (PQC) was not involved.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist on behalf of a nurse, regarding an approximately 21 year old patient (gender not provided). The patient's concurrent, historical conditions and concomitant medications were not reported. On an unspecified date in 2015, the patient was vaccinated with the first dose of GARDASIL intramuscularly (dosage, anatomical location, lot number and expiration date were not provided). On unknown day in 2017, the patient was vaccinated with the second dose of GARDASIL by intramuscular route (dosage, anatomical location, lot number and expiration date were not provided). On 24-OCT-2018, the patient was vaccinated with the third dose of GARDASIL intramuscularly, lot number N035957 and expiration date of 10-OCT-2020 (dosage not reported) all dosed indicated for prevention of Human papillomavirus infection (HPV). No adverse effects was reported. No Product Quality Complaint was reported.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site pain, Musculoskeletal disorder, Pain in extremity, Tendonitis
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of tendonitis in a 81-year-old female patient who received SHINGRIX for prophylaxis. Concomitant products included ADVIL. On 17th October 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 17th October 2018, immediately after receiving SHINGRIX, the patient experienced pain in arm. On 19th October 2018, the patient experienced tendonitis. On an unknown date, the outcome of the tendonitis and pain in arm were not recovered/not resolved. It was unknown if the reporter considered the tendonitis and pain in arm to be related to SHINGRIX. Additional information received as follows: The patient's concomitant product included Amivok. The patient received SHINGRIX on the left arm. The patient reported that she experienced a sore arm after receiving the dose of SHINGRIX but it was not terrible. By Friday, she had extreme tendinitis in both hands but it was worse in the left hand than the right hand. She could not use her left hand at all. The tendinitis was in her wrists and between her fingers on both hands. The patient also had injection site pain immediately and the injection site was sore to the touch after the shot. The tendinitis started on Friday evening and then she woke up Saturday morning and it was full blown. She was wondering if it could be related to her new migraine injection medication which was considered an immunosuppressant therapy. She had tried to soak her hand and had tried to cool and heat the area and nothing would resolved the tendinitis.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Mobility decreased, Movement disorder, Muscle spasms, Pain, Pain in extremity
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 57-year-old female patient who received FLUARIX QUADRIVALENT (2018-2019 season) (batch number 74BL5, expiry date 30th June 2019) for prophylaxis. On 18th October 2018, the patient received FLUARIX QUADRIVALENT 2018-2019 season (intramuscular) .5 ml. On 19th October 2018, 1 days after receiving FLUARIX QUADRIVALENT 2018-2019 season, the patient experienced pain in arm, muscle spasm, movement disorder and swelling arm. On an unknown date, the outcome of the pain in arm, muscle spasm, movement disorder and swelling arm were not recovered/not resolved. It was unknown if the reporter considered the pain in arm, muscle spasm, movement disorder and swelling arm to be related to FLUARIX QUADRIVALENT 2018-2019 season. Additional details were provided as follows: The pharmacist reported that the patient received FLUARIX QUADRIVALENT in the left arm and the next day her arm was sore and swollen and it felt like the muscle in the arm was knotted up. The day before the time of reporting, the patient visited her gynecologist for a routine appointment and had a blood draw as part of the appointment. After the blood draw her arm swelled up even more and was puffy above the elbow. The symptoms were continuing to get worse and it was difficult for her to rotate her arm outward and she did not want to move her arm very much because it was sore.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Peripheral swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 57-year-old female patient who received FLUARIX QUADRIVALENT (2018-2019 season) (batch number 74BL5, expiry date 30th June 2019) for prophylaxis. On 18th October 2018, the patient received FLUARIX QUADRIVALENT 2018-2019 season (intramuscular) .5 ml. On 19th October 2018, 1 days after receiving FLUARIX QUADRIVALENT 2018-2019 season, the patient experienced pain in arm, muscle spasm, movement disorder and swelling arm. On an unknown date, the outcome of the pain in arm, muscle spasm, movement disorder and swelling arm were not recovered/not resolved. It was unknown if the reporter considered the pain in arm, muscle spasm, movement disorder and swelling arm to be related to FLUARIX QUADRIVALENT 2018-2019 season. Additional details were provided as follows: The pharmacist reported that the patient received FLUARIX QUADRIVALENT in the left arm and the next day her arm was sore and swollen and it felt like the muscle in the arm was knotted up. The day before the time of reporting, the patient visited her gynecologist for a routine appointment and had a blood draw as part of the appointment. After the blood draw her arm swelled up even more and was puffy above the elbow. The symptoms were continuing to get worse and it was difficult for her to rotate her arm outward and she did not want to move her arm very much because it was sore.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash pustular
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of blister in a 71-year-old male patient who received SHINGRIX (batch number EH9Z7, expiry date 8th March 2021) for prophylaxis. On 17th October 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 20th October 2018, 3 days after receiving SHINGRIX, the patient experienced blister. On an unknown date, the outcome of the blister was not recovered/not resolved. It was unknown if the reporter considered the blister to be related to SHINGRIX. Additional details were provided as follows: On Wednesday at 11:30 am, the patient received SHINGRIX on the left deltoid and by Saturday the patient had puss like blisters on his chest. Initially there were 6 to 7 blisters and at the time of reporting there was a patch of blisters.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pain in extremity, Pain of skin, Pruritus, Rash
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of shingles in a 71-year-old female patient who received SHINGRIX (batch number L7F7E, expiry date 22nd November 2020) for prophylaxis. On 7th August 2018, the patient received SHINGRIX. On 17th August 2018, 10 days after receiving SHINGRIX, the patient experienced shingles, pain of skin and itchy skin. On 20th August 2018, the patient experienced rash. On an unknown date, the patient experienced pain in arm. On an unknown date, the outcome of the shingles, rash, pain of skin and itchy skin were unknown and the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the shingles, pain in arm, rash, pain of skin and itchy skin to be related to SHINGRIX. Additional details were provided as follows: The healthcare professional reported that after receiving SHINGRIX, the patient experienced painful arm (less than a month after vaccination) for greater than 7 days. The patient's skin on her back became painful. Ten days after receiving SHINGRIX, the patient experienced shingles and the patient's skin on her back was itchy. Thirteen days after receiving SHINGRIX, the patient's skin on her back had rash. Less than a month after receiving SHINGRIX, the patient's skin on her back had rash.
Sex: M
Vaccine: FLU4
Symptoms: Rash, Skin induration, Urticaria
Clinical narrative: This case was reported by a non-health professional via call center representative and described the occurrence of raised rash in a child male patient who received FLULAVAL QUADRIVALENT for prophylaxis. On an unknown date, the patient received FLULAVAL QUADRIVALENT at an unknown dose. On an unknown date, less than a year after receiving FLULAVAL QUADRIVALENT, the patient experienced raised rash, skin induration and hives. On an unknown date, the outcome of the raised rash, skin induration and hives were unknown. It was unknown if the reporter considered the raised rash, skin induration and hives to be related to FLULAVAL QUADRIVALENT. Additional details were provided as follows: The age at vaccination was not reported. The patient developed a hard raised rash and hives after receiving a dose of FLULAVAL QIV at another facility years ago. No further information was reported regarding the event.
Age: 51.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Feeling abnormal, Pruritus, Rash
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of rash in a 51-year-old female patient who received SHINGRIX (batch number 5NY5G, expiry date unknown) for prophylaxis. Concomitant products included PNEUMOVAX and prednisone. On 2nd October 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 3rd October 2018, 1 days after receiving SHINGRIX, the patient experienced rash, feeling abnormal and pruritus. On an unknown date, the outcome of the rash, feeling abnormal and pruritus were unchanged. It was unknown if the reporter considered the rash, feeling abnormal and pruritus to be related to SHINGRIX. Additional information was reported as follows: The patient was vaccinated with SHINGRIX and PNEUMOVAX at different arms on the same day. The patient developed rash which felt like woolen pants down from the waist. From 3rd October 2018, the symptoms had remained unchanged till the date of reporting. The patient took Prednisone for the events, but it was prescribed for a pre-existing condition and was not prescribed for the events experienced by the patient after vaccination with SHINGRIX.