chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RVX
Symptoms: Expired product administered, No adverse event
Clinical narrative: Initial information received on 03-Jan-2019 regarding an unsolicited valid non-serious case received from a nurse. This case involves a six-months-old male patient who received an 0.5 ml second dose of expired PENTACEL (lot number: C5456AA, expiry date: 18-Dec-2018) via intramuscular route in an unknown site of administration on 03-Jan-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included HEPATITIS B VACCINE for Immunisation; ROTAVIRUS VACCINE for Immunisation; and PREVNAR for Immunisation on 03-Jan-2019. It was a case of actual medication error due to expired vaccine used. Did not observe any side effects after the injection. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site bruising, Injection site discolouration
Clinical narrative: Initial information received on 07-Jan-2019 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 65 years old female patient who experienced black mark on their arm from where they received FLUZONE HD. 5 inch in diameter, black bruise at the injection site, while she received vaccine FLUZONE HIGH DOSE. The patients past medical history, concomitant medication and family history were not provided. On 28-Dec-2018, the patient received a 0.5ml dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ030AA, expiry date 05-May-2019 via intramuscular route in the arm nos. On an unknown date, the patient developed a non-serious black mark on their arm from where they received FLUZONE HD. 5 inch in diameter, black bruise at the injection site (skin discolouration) (vaccination site reaction) with unknown latency following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. Lab data was not provided. Final diagnosis was black mark on their arm from where they received fluzone hd. 5 inch in diameter, black bruise at the injection site and black mark on their arm from where they received FLUZONE HD. 5 inch in diameter, black bruise at the injection site. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for black mark on their arm from where they received FLUZONE HD. 5 inch in diameter, black bruise at the injection site. List of documents held by sender- none.
Age: 30.0
Sex: M
Vaccine: FLU4
Symptoms: Chills, Flank pain, Pain
Clinical narrative: At around 0700 hrs of 01/11/19 I begin experiencing chills and body aches throughout my body. Also, experienced left flank pain 4/10 pain scale. Self-administered ibuprofen 600 mg for pain, body aches, and chills @ 0720 hrs.
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site warmth, Soft tissue swelling
Clinical narrative: Soft tissue swelling circumstantially around arm with heat and redness below injection site. Extremely tender and painful to touch. Seen in ED this am due to pain and difficulty in mobility of arm. BENADRYL provided and individual sent home from work.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Injection site erythema, Injection site induration, Injection site inflammation
Clinical narrative: Patient has red 2x2 raised hard inflammed area of skin at the injection site on her left arm. The left arm at the injection site is warm to the touch and  painful. Patient started having fever, chills, body aches, and general fatigue feeling about 12 hours after the vaccine was given and lasted for about 36 hours. Patient had same fever and body aches when she had the first injection.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling, Injection site warmth, Pain, Pyrexia
Clinical narrative: Patient has red 2x2 raised hard inflammed area of skin at the injection site on her left arm. The left arm at the injection site is warm to the touch and  painful. Patient started having fever, chills, body aches, and general fatigue feeling about 12 hours after the vaccine was given and lasted for about 36 hours. Patient had same fever and body aches when she had the first injection.
Age: 21.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Erythema, Swelling
Clinical narrative: Swelling and erythema noted.
Age: 16.0
Sex: F
Vaccine: HEPA
Symptoms: Eye swelling, Lip swelling, Pruritus, Urticaria
Clinical narrative: Pt developed hives and itching of trunk, arms and neck. She then developed swelling of the left lip and eye. No airway distress.
Age: 0.75
Sex: M
Vaccine: HIBV
Symptoms: Asterixis, Condition aggravated, Malaise, Pertussis, Upper respiratory tract infection
Clinical narrative: As stated above. He was sick after every round of vaccines. He would get an upper respiratory infection. Ear infections, colicky, sensitivity to sounds, night terrors, he has been having severe tantrums and high pitch screaming since before he was 6 months old. He would either have constipation or explosive diarrhea. His stool is still not solid. He had reflux until he started eating solid foods. He will only eat carbohydrates now and fruit. He has repetitive behaviors, OCD, severe  behavioral tantrums and is  very defiant. After the vaccines on 10/20/2016 he no longer said words until after 2 years with help from natural remedies. He stopped listening to his name after the 10/20/2016 vaccinations. With the help of natural remedies he is now listening to his name. He still does not sleep through the night. He definitely has issues with attention. He has not played with toys like a normal child since 6 months old. He started flapping his hands around a yr old after the 1/20/2017 adverse reaction. The night of the event we heard loud high pitch screaming. He was inconsolable and having convulsions. He had a high fever over 104 that persisted for days. He then started banging his head in his crib. The head banging continued for 9 months when he would be frustrated or upset. After the adverse reaction on 1/20/2017, He came down with another severe upper respiratory infection, what seemed to be whooping cough and was sick until the week of March 26, 2017. I called his pediatricians office, to report the incident the following day. I was told by the nurse there was no way it was the vaccine. I did not return to their office.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Peripheral swelling, Skin warm
Clinical narrative: Patient states her arm was very swollen and warm after the vaccine. It is almost a month later and she states the injection site is still tender to the touch.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Burning sensation, Ear pain, Fatigue, Immediate post-injection reaction
Clinical narrative: Pain, redness, and swelling immediately at injection site...and pain, redness, heat, and swelling at injection site for a week. Flu-like symptoms for two weeks ---  general muscular/joint aches and pains and exhaustion. This progressed to ear and sinus pain -- sinus pain was unlike anything I'd ever experienced. Burning in sinus cavity. Terribly painful. Went to Dr. at this point --- was prescribed antibiotics for sinus infection. Was off work for almost three weeks. Have never had an adverse reaction to a shot prior to this.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Impaired work ability, Influenza like illness, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pain, redness, and swelling immediately at injection site...and pain, redness, heat, and swelling at injection site for a week. Flu-like symptoms for two weeks ---  general muscular/joint aches and pains and exhaustion. This progressed to ear and sinus pain -- sinus pain was unlike anything I'd ever experienced. Burning in sinus cavity. Terribly painful. Went to Dr. at this point --- was prescribed antibiotics for sinus infection. Was off work for almost three weeks. Have never had an adverse reaction to a shot prior to this.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Myalgia, Pain, Sinus pain, Sinusitis
Clinical narrative: Pain, redness, and swelling immediately at injection site...and pain, redness, heat, and swelling at injection site for a week. Flu-like symptoms for two weeks ---  general muscular/joint aches and pains and exhaustion. This progressed to ear and sinus pain -- sinus pain was unlike anything I'd ever experienced. Burning in sinus cavity. Terribly painful. Went to Dr. at this point --- was prescribed antibiotics for sinus infection. Was off work for almost three weeks. Have never had an adverse reaction to a shot prior to this.
Age: 12.0
Sex: M
Vaccine: FLU4
Symptoms: Headache, Nausea, Pyrexia, Swelling of eyelid, Vomiting
Clinical narrative: He was very nauseous upon waking and threw up once. Then complained of a bad headache. Fever developed over a period of hours getting up to 101.8. His eyes were puffy and the fever lasted until about hour 29 and it started going down fairly quickly. He was completely fine the next morning (40 hours or so later).
Age: 1.33
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a 16 month old patient of unknown gender. The patient's pertinent medical history and drug reactions/allergies were unknown. On 04-JAN-2019, the patient was vaccinated with an expired dose of M-M-R II (lot # M049212, expiration date: 16-DEC-2018) (anantomical location, route and dosing details not reported) for prophylaxis along with sterile diluent (concomitant medicaton). No adverse effects reported. Product quality complaint was not involved.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. The patient's healthcare provider recommended, and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. In 2012, a physician administered ZOSTAVAX, (lot # and route unknown) to the patient. The patient was inoculated with the ZOSTAVAX vaccine to obtain permanent prevention and protection against shingles and zoster-related injuries. In 2012, the patient was treated by a physician 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. The patient used the ZOSTAVAX vaccine for the permanent prevention of shingles and zoster-related injuries. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine. 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; lost wages; loss of earnings capacity; and other losses and damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
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. The patient's healthcare provider(s) 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 23-FEB-2016, a pharmacist at a pharmacy administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). In APRIL 2016, the patient was treated by a healthcare provider at a healthcare facility/clinic 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 patient's injuries. As a direct and proximate result of ZOSTAVAX, 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 including 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 (not specified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was not recovered. Causality assessment was related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Cerebrovascular accident, Herpes zoster
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. The patient's healthcare provider(s) 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 10-JAN-2017, a healthcare provider at a pharmacy administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 27-JAN-2017, the patient was treated by a physician at a hospital for stroke. 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 patient's injuries. As a direct and proximate result of ZOSTAVAX, 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 including 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 (not specified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was not recovered.  Causality assessment was related. Upon internal review, stroke was determined to be a medically significant event. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
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. The patient's healthcare provider(s) recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. In DECEMBER 2011, a pharmacist at a pharmacy administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 19-FEB-2012, the patient was treated by a healthcare provider at a hospital 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 patient's injuries. As a direct and proximate result of ZOSTAVAX, 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 including 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 (not specified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was not recovered. Causality assessment was related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia
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. The patient's healthcare providers 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  27-SEP-2016, a pharmacist administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 11-FEB-2017 and 04-APR-2017, the patient was treated by physicians at a hospital and physician's office for shingles and post herpetic neuralgia respectively. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX, 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 including 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; 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.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 08-JAN-2019, the patient was vaccinated with VAQTA 25/0.5 (units not provided), lot # N023953, which expired on 05-NOV-2018 (dose, route and anatomical location were not reported). No adverse event was reported. This is one of two reports received from the same source. Sender's Comments: US-009507513-1901USA002741.
Sex: F
Vaccine: VARZOS
Symptoms: Encephalitis, Nuclear magnetic resonance imaging, Paraesthesia, Partial seizures, Tremor
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of focal seizures in a 74-year-old female patient who received SHINGRIX for prophylaxis. In December 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, 14 days after receiving SHINGRIX, the patient experienced focal seizures (serious criteria GSK medically significant), encephalitis (serious criteria GSK medically significant), tremor limb, tingling and vasculitis. On an unknown date, the outcome of the focal seizures, encephalitis and vasculitis were unknown and the outcome of the tremor limb was recovered/resolved and the outcome of the tingling was not recovered/not resolved. It was unknown if the reporter considered the focal seizures, encephalitis, tremor limb, tingling and vasculitis to be related to SHINGRIX. Additional information received as follows: The case was reported by the patient's relative. The age at vaccination was not reported. It was believed that the SHINGRIX was given in mid December 2018, exact dates of vaccination was not provided. The patient experienced might be a focal partial seizure. The patient experienced right sided arm shaking and tingling on whole right side of body had not subsided. On an unknown date, the patient underwent Nuclear magnetic resonance imaging and the results revealed potential vasculitis or encephalitis. The patient did not experience numbness, weakness, pain or rash, loss of consciousness and event related to bowel or bladder. The lot number, exact date of vaccination was not available. No official diagnosis had been made till the reporting time. Emergency room visit required. The reporter did not consent to follow-up. Lab Comments: On an unknown date, the patient underwent Nuclear magnetic resonance imaging and the findings revealed potential vasculitis or encephalitis.
Sex: F
Vaccine: VARZOS
Symptoms: Vasculitis
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of focal seizures in a 74-year-old female patient who received SHINGRIX for prophylaxis. In December 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, 14 days after receiving SHINGRIX, the patient experienced focal seizures (serious criteria GSK medically significant), encephalitis (serious criteria GSK medically significant), tremor limb, tingling and vasculitis. On an unknown date, the outcome of the focal seizures, encephalitis and vasculitis were unknown and the outcome of the tremor limb was recovered/resolved and the outcome of the tingling was not recovered/not resolved. It was unknown if the reporter considered the focal seizures, encephalitis, tremor limb, tingling and vasculitis to be related to SHINGRIX. Additional information received as follows: The case was reported by the patient's relative. The age at vaccination was not reported. It was believed that the SHINGRIX was given in mid December 2018, exact dates of vaccination was not provided. The patient experienced might be a focal partial seizure. The patient experienced right sided arm shaking and tingling on whole right side of body had not subsided. On an unknown date, the patient underwent Nuclear magnetic resonance imaging and the results revealed potential vasculitis or encephalitis. The patient did not experience numbness, weakness, pain or rash, loss of consciousness and event related to bowel or bladder. The lot number, exact date of vaccination was not available. No official diagnosis had been made till the reporting time. Emergency room visit required. The reporter did not consent to follow-up. Lab Comments: On an unknown date, the patient underwent Nuclear magnetic resonance imaging and the findings revealed potential vasculitis or encephalitis.
Age: 21.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Nausea, Presyncope
Clinical narrative: Patient experienced a vasovagal event within one minute of vaccination, became lightheaded and nauseated. Patient was placed in trendellenberg position and given gatorade. Patient was returned to upright seated over 10 minutes, given crackers to eat, able to stand and walk without problems, and waited an additional 5 minutes in the waiting room. Discharged without further even.
Age: 77.0
Sex: F
Vaccine: PNC13
Symptoms: Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Patient states that about a week later he noticed tightness and pain in the arm. When asked did he take anything for it such as ibuprofen or TYLENOL, he said no, he doesn't take those. Appearance of arm is smooth with no redness, bruising or any markings present. Patient stated pain was severe after holding phone for 45 minutes.
Age: 0.17
Sex: F
Vaccine: RV5
Symptoms: Haematochezia
Clinical narrative: Blood in stool- lasted 2 weeks.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Parotid gland enlargement, Salivary gland pain
Clinical narrative: Within 30-36 hours of receiving the MMRV, patient developed painful swelling at bilateral parotid glands, right worse than left. This worsened over the next few days. No fevers. No purulent drainage at Stensen's duct. Given the multiple possible etiologies of parotitis (post-viral, viral, bacterial, MMRV vaccine), I started him on AUGMENTIN for possible bacterial etiology. He plans to f/u in one week.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Nausea
Clinical narrative: Severe headache (still), nausea, (still).
Age: 4.0
Sex: M
Vaccine: DTAPHEPBIP, FLU4, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Lacrimation increased, Swelling face, Tongue disorder, Urticaria, Wheezing
Clinical narrative: At 3:50 PM, Mother returned to health department (approx. 30 minutes after vaccines were administered.) Child demonstrated facial swelling, watery eyes, occasional wheezing, and hives.  Child pulled at his tongue at times, no swelling of the tongue was noted. EMS activated and child transferred to ETC at 3:55 PM.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Dizziness, Headache, Injection site pain, Mobility decreased
Clinical narrative: Upon waking this morning I got very dizzy and needed to lie back down. This happened 3 or 4 times. I have a slight headache, feel achy (especially in my back), injection site hurts and it is difficult for me to raise my arms above my head.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Upon waking this morning I got very dizzy and needed to lie back down. This happened 3 or 4 times. I have a slight headache, feel achy (especially in my back), injection site hurts and it is difficult for me to raise my arms above my head.
Age: 6.0
Sex: F
Vaccine: DTAP
Symptoms: Erythema, Pain in extremity, Pruritus, Skin warm, Swelling
Clinical narrative: Leg pain, itching, Swelling, redness, warm to touch. No fever. Pt is able to walk normal on it. Treatment: cold pack, give ibuprofen. And BENADRYL later if still c/o itchiness. Can draw a circle around the redness to see if it gets any bigger. Monitor for any worsening of symptoms. Office visit on 1/10 for follow-up, and symptoms had improved.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Discomfort, Erythema, Injection site erythema, Pain, Swelling
Clinical narrative: Redness, swelling, soreness through 3rd day. Redness about 1 inch wide and 6 inches long at immunization site on upper left arm. Shot on 1/8/19 and still redness and discomfort on 1/11/19. Ibuprofen for soreness.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
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 concurrent conditions, medical history, or concomitant medications. In February 2016, a pharmacist at a pharmacy administered ZOSTAVAX to the patient to obtain permanent prevention and protection against shingles and zoster-related injuries/conditions (dose, route, and lot # not provided). In February 2016, the patient was treated by a physician at a medical office for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of ZOSTAVAX, 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 including 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; lost wages; loss of earnings capacity; and other losses and damages.  The outcome of the events was not recovered. Causality assessment was related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
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. The patient's healthcare provider(s) recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. In MAY 2015, a pharmacist at a pharmacy administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). In JANUARY 2017, the patient was treated by a physician at a medical group office 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 patient's injuries. As a direct and proximate result of ZOSTAVAX, 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 including 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 (not specified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was not recovered. Causality assessment was related. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Herpes zoster disseminated, Polymerase chain reaction positive, Pyrexia, Rash vesicular
Clinical narrative: This literature marketed report has been received from the authors of a published literature article,  and refers to a 62-year-old male patient with history of obesity and obstructive sleep apnea. On an unknown date, the patient was vaccinated with ZOSTAVAX injection (dose, route of administration, injection site, lot number and expiration date were not provided) for prophylaxis. On an unknown date, 19 days later, the patient developed disseminated herpes zoster or varicella-like rash with slight fever and fatigue. The patient received unspecified treatment and on an unknown date, he recovered from the events. On an unknown date, a polymerase chain reaction (PCR) test was performed on an unspecified specimen from the patient and confirmed a vaccine strain varicella-zoster virus. The authors considered the events to be related to ZOSTAVAX. Upon internal review, the event of disseminated herpes zoster was considered to be medically significant. This is one of several reports derived from the same literature article (cross referenced with MARRS 1109USA00990, 1306USA004543, 1708USA001383, 1303USA012949, 1411USA011593).
Sex: M
Vaccine: VARZOS
Symptoms: Varicella virus test positive
Clinical narrative: This literature marketed report has been received from the authors of a published literature article,  and refers to a 62-year-old male patient with history of obesity and obstructive sleep apnea. On an unknown date, the patient was vaccinated with ZOSTAVAX injection (dose, route of administration, injection site, lot number and expiration date were not provided) for prophylaxis. On an unknown date, 19 days later, the patient developed disseminated herpes zoster or varicella-like rash with slight fever and fatigue. The patient received unspecified treatment and on an unknown date, he recovered from the events. On an unknown date, a polymerase chain reaction (PCR) test was performed on an unspecified specimen from the patient and confirmed a vaccine strain varicella-zoster virus. The authors considered the events to be related to ZOSTAVAX. Upon internal review, the event of disseminated herpes zoster was considered to be medically significant. This is one of several reports derived from the same literature article (cross referenced with MARRS 1109USA00990, 1306USA004543, 1708USA001383, 1303USA012949, 1411USA011593).
Sex: M
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: This spontaneous report was received from a male patient of unknown age, who was also the reporting pharmacist. His current condition included asthma. No information regarding the patient's concomitant medications, drug reactions or allergies was provided. On an unknown date, the pharmacist was vaccinated with PNEUMOVAX 23 injection, intramuscularly (lot number, expiration date, anatomical location and dose was not provided) to prevent pneumococcal infection. On the following day after the PNEUMOVAX 23 injection, he developed severe pain in the arm that had received the vaccination. He also had trouble lifting that arm. He did not sought medical attention. The outcome of injection site movement impairment and injection site pain was reported as recovered at the time of the report. The causality assessment between the events and the suspect therapy was not provided.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site erythema, Injection site pain, Peripheral swelling, Pruritus
Clinical narrative: This case was reported by a consumer and described the occurrence of injection site erythema in a female patient who received SHINGRIX (batch number G45LN, expiry date unknown) and (batch number 5S34K, expiry date unknown) for prophylaxis. On 28th November 2018, the patient received SHINGRIX. On an unknown date, the dose was an unknown dose. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced injection site erythema, injection site pain, swelling of legs, rash, redness of legs and itchy legs. On an unknown date, the outcome of the injection site erythema, injection site pain, swelling of legs, rash, redness of legs and itchy legs were unknown.  It was unknown if the reporter considered the injection site erythema, injection site pain, swelling of legs, rash, redness of legs and itchy legs to be related to SHINGRIX. Additional details were provided as follows: This case was reported by a pharmacy via pharmacy claims management company. The age at vaccination was not reported. The patient received SHINGRIX on an unknown arm. The patient's calves became itchy, red, puffy and rash-like. The patient developed redness and soreness on her arm where the vaccine was administered.
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This case was reported by a consumer and described the occurrence of injection site erythema in a female patient who received SHINGRIX (batch number G45LN, expiry date unknown) and (batch number 5S34K, expiry date unknown) for prophylaxis. On 28th November 2018, the patient received SHINGRIX. On an unknown date, the dose was an unknown dose. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced injection site erythema, injection site pain, swelling of legs, rash, redness of legs and itchy legs. On an unknown date, the outcome of the injection site erythema, injection site pain, swelling of legs, rash, redness of legs and itchy legs were unknown.  It was unknown if the reporter considered the injection site erythema, injection site pain, swelling of legs, rash, redness of legs and itchy legs to be related to SHINGRIX. Additional details were provided as follows: This case was reported by a pharmacy via pharmacy claims management company. The age at vaccination was not reported. The patient received SHINGRIX on an unknown arm. The patient's calves became itchy, red, puffy and rash-like. The patient developed redness and soreness on her arm where the vaccine was administered.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dehydration, Feeling abnormal, Feeling cold, Headache
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of feeling cold in a 53-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of injection site pain (For tolerance of 1st dose refer case US2019GSK004333). On 2nd January 2019, the patient received the 2nd dose of SHINGRIX. On 2nd January 2019, less than an hour after receiving SHINGRIX, the patient experienced feeling cold and shivering. On 3rd January 2019, the patient experienced feeling abnormal, general body pain, headache and fever. On an unknown date, the outcome of the feeling cold, shivering, feeling abnormal, general body pain, headache and fever were unknown. It was unknown if the reporter considered the feeling cold, shivering, feeling abnormal, general body pain, headache and fever to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported but it could be 52 years or 53 years. Within an hour after vaccination, the patient experienced freezing, shivering and was coud not get warm. The patient went to bed and was shivering like crazy and it took heavy clothes blankets and heating pad to warm. The patient woke up feeling like she was hit by a truck, whole body aches and headache and feeling dehydrated. The patient also woke with slight fever of 99.6 degree F.
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of feeling cold in a 53-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of injection site pain (For tolerance of 1st dose refer case US2019GSK004333). On 2nd January 2019, the patient received the 2nd dose of SHINGRIX. On 2nd January 2019, less than an hour after receiving SHINGRIX, the patient experienced feeling cold and shivering. On 3rd January 2019, the patient experienced feeling abnormal, general body pain, headache and fever. On an unknown date, the outcome of the feeling cold, shivering, feeling abnormal, general body pain, headache and fever were unknown. It was unknown if the reporter considered the feeling cold, shivering, feeling abnormal, general body pain, headache and fever to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported but it could be 52 years or 53 years. Within an hour after vaccination, the patient experienced freezing, shivering and was coud not get warm. The patient went to bed and was shivering like crazy and it took heavy clothes blankets and heating pad to warm. The patient woke up feeling like she was hit by a truck, whole body aches and headache and feeling dehydrated. The patient also woke with slight fever of 99.6 degree F.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This case was reported by a pharmacist via patient support programs and described the occurrence of injection site pain in a 63-year-old female patient who received SHINGRIX (batch number 9KT7T, expiry date unknown) for prophylaxis. On 25th November 2018, the patient received SHINGRIX 0.5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided as follows: This case was received from the healthcare provider via the vaccine patient assistance program. The patient received vaccine injection in the left arm and was suffering from soreness at injection site for over one month. The event product complaint did not include in the case. No further information was provided at time of reporting. The reporter had agreed to have safety team follow-up with them via postal mail.
Age: 0.08
Sex: M
Vaccine: HEP
Symptoms: Rash generalised
Clinical narrative: This case was reported by a physician via other manufacturer and described the occurrence of generalized rash in a 5-week-old male patient who received ENGERIX B for prophylaxis. On 16th December 2018, the patient received Engerix B. On 24th December 2018, 8 days after receiving ENGERIX B, the patient experienced generalized rash. On an unknown date, the outcome of the generalized rash was unknown. It was unknown if the reporter considered the generalized rash to be related to ENGERIX B. Additional details were provided as follows: The patient developed rash all over his body. No further information was provided and was not associated with product quality compliant. The reporter declined to contact Merck for additional information and this information was not reported to FDA.
Sex: U
Vaccine: VARZOS
Symptoms: Adverse event
Clinical narrative: This case was reported by a consumer via other manufacturer and described the occurrence of adverse event in an unspecified number of adult patients who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, unknown after receiving SHINGRIX, the patient experienced adverse event (serious criteria other: Serious per reporter). On an unknown date, the outcome of the adverse event was unknown. It was unknown if the reporter considered the adverse event to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not applicable for this report. The age group was not reported, but was selected adult as per vaccine indication. The reporter mentioned that, her physician did not want her to get vaccinated with SHINGRIX for shingles prevention because the physician had unspecified number of patients who did get the SHINGRIX vaccine and experienced serious complications (unspecified). The reporter did not herself received SHINGRIX, because the physician had concern about this particular brand of vaccine. No additional adverse event information was given.
Sex: M
Vaccine: VARZOS
Symptoms: Nuclear magnetic resonance imaging brain normal, Trigeminal neuralgia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of trigeminal neuralgia in a male patient who received SHINGRIX for prophylaxis. In July 2018, the patient received the 1st dose of SHINGRIX. In August 2018, 28 days after receiving SHINGRIX, the patient experienced trigeminal neuralgia. On an unknown date, the outcome of the trigeminal neuralgia was unknown. It was unknown if the reporter considered the trigeminal neuralgia to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received the dose of the SHINGRIX vaccine in late July 2018 and then about 4 weeks later, developed trigeminal nerve pain. The patient's neurologist conducted a brain magnetic resonance imaging which showed no causes from the brain. The patient was wondering if the SHINGRIX vaccination could have been the cause. The patient needed to make a decision soon about getting the 2nd dose of the SHINGRIX vaccine so the patient asked if GlaxoSmithKline had any information regarding a possible cause and effect relationship between SHINGRIX and trigeminal nerve pain.
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 21-year-old female patient who received Flu unspecified (Influenza vaccine) for prophylaxis. Concurrent medical conditions included autism, tourette's syndrome, charcot-marie-tooth disease, attention deficit/hyperactivity disorder, obsessive-compulsive disorder, endocrine disorder (Endocrine problems) and allergy. On an unknown date, the patient received Influenza vaccine at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine, the patient experienced injection site erythema and injection site swelling. On an unknown date, the outcome of the injection site erythema and injection site swelling were unknown. It was unknown if the reporter considered the injection site erythema and injection site swelling to be related to Influenza vaccine. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced extremely red swollen injection site. For tolerability of FLULAVAL QUADRIVALENT 2018-2019 season vaccine, refer case US2018218622.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Erythema, Pain, Peripheral swelling, Pyrexia
Clinical narrative: Patient describes local soreness and redness with swelling to left arm starting same day. On 1-8-19 she began to experience chills, fever and general achiness. The 3rd day she stated that she was experiencing swelling with a rash all around her neck and throat. She stated that it has started to diminish now and deferred an office visit but wanted to make sure SHINGRIX is listed on her adverse event lsit and is very unwilling to get the second booster shot. She was given signs and symptoms of anaphylactic reaction.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Swelling
Clinical narrative: Patient describes local soreness and redness with swelling to left arm starting same day. On 1-8-19 she began to experience chills, fever and general achiness. The 3rd day she stated that she was experiencing swelling with a rash all around her neck and throat. She stated that it has started to diminish now and deferred an office visit but wanted to make sure SHINGRIX is listed on her adverse event lsit and is very unwilling to get the second booster shot. She was given signs and symptoms of anaphylactic reaction.