chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 45.0
Sex: F
Vaccine: FLUC4
Symptoms: Anxiety, Chills, Dizziness, Dysphonia, Laboratory test
Clinical narrative: This serious spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 11-Jun-2018 by Seqirus from VAERS (VAERS ID: 714298), concerns a 45-year-old, adult, female patient. The patient did not have any medical history. The patient's current condition included allergic to REGLAN, quinolones, DEMEROL. The patient's concomitant medication included TYLENOL for an unknown indication. On 22-Sep-2017, the patient was administered with FLUCELVAX QIV, (dose: 0.5 ml (1 as reported), route of administration: injection (SYR as reported), anatomical location: right arm, batch number: 682964 as reported). On the same day (22-Sep-2017), within 5 minutes after vaccination, the patient became dizzy, felt anxious and restlessness. The patient's voice became hoarse and her neck began to hurt. After 20 to 30 minutes of vaccination, these symptoms dissipated to be followed by chills and itching on forearms and knees. It was reported that, a call was made to the pharmacy and the pharmacist had suggested to use BENADRYL. The patient took BENADRYL as treatment. On 23-Sep-2017, the following morning, the patient awoke with itchy, raised red rash under arm, which extended up to the inner arm and down towards breast. The patient also had tingling sensation in the arm down to fingers, felt like three fingers with pins and needles (middle thru pinkie fingers). As the day progressed, rash became painful, stinging more than itching. Around 8:00 PM, the patient's tongue began burning appeared like a lime sunburn or exposed to excess citric acid. On the next day (24-Sep-2017), the patient went to urgent care where the doctor believed that the rash might be shingles. However, Stevens-Johnson syndrome [SJS] was not ruled out. The doctor did not explain anything about burning mouth. The condition persisted for 48 hours followed by vaccination. On 24-Sep-2017, unspecified lab examinations were performed (results not available). At the time of this report, the patient had not yet recovered from the events.
Age: 45.0
Sex: F
Vaccine: FLUC4
Symptoms: Neck pain, Pain, Paraesthesia, Pruritus, Rash
Clinical narrative: This serious spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 11-Jun-2018 by Seqirus from VAERS (VAERS ID: 714298), concerns a 45-year-old, adult, female patient. The patient did not have any medical history. The patient's current condition included allergic to REGLAN, quinolones, DEMEROL. The patient's concomitant medication included TYLENOL for an unknown indication. On 22-Sep-2017, the patient was administered with FLUCELVAX QIV, (dose: 0.5 ml (1 as reported), route of administration: injection (SYR as reported), anatomical location: right arm, batch number: 682964 as reported). On the same day (22-Sep-2017), within 5 minutes after vaccination, the patient became dizzy, felt anxious and restlessness. The patient's voice became hoarse and her neck began to hurt. After 20 to 30 minutes of vaccination, these symptoms dissipated to be followed by chills and itching on forearms and knees. It was reported that, a call was made to the pharmacy and the pharmacist had suggested to use BENADRYL. The patient took BENADRYL as treatment. On 23-Sep-2017, the following morning, the patient awoke with itchy, raised red rash under arm, which extended up to the inner arm and down towards breast. The patient also had tingling sensation in the arm down to fingers, felt like three fingers with pins and needles (middle thru pinkie fingers). As the day progressed, rash became painful, stinging more than itching. Around 8:00 PM, the patient's tongue began burning appeared like a lime sunburn or exposed to excess citric acid. On the next day (24-Sep-2017), the patient went to urgent care where the doctor believed that the rash might be shingles. However, Stevens-Johnson syndrome [SJS] was not ruled out. The doctor did not explain anything about burning mouth. The condition persisted for 48 hours followed by vaccination. On 24-Sep-2017, unspecified lab examinations were performed (results not available). At the time of this report, the patient had not yet recovered from the events.
Age: 45.0
Sex: F
Vaccine: FLUC4
Symptoms: Rash erythematous, Rash pruritic, Restlessness, Tongue discomfort
Clinical narrative: This serious spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 11-Jun-2018 by Seqirus from VAERS (VAERS ID: 714298), concerns a 45-year-old, adult, female patient. The patient did not have any medical history. The patient's current condition included allergic to REGLAN, quinolones, DEMEROL. The patient's concomitant medication included TYLENOL for an unknown indication. On 22-Sep-2017, the patient was administered with FLUCELVAX QIV, (dose: 0.5 ml (1 as reported), route of administration: injection (SYR as reported), anatomical location: right arm, batch number: 682964 as reported). On the same day (22-Sep-2017), within 5 minutes after vaccination, the patient became dizzy, felt anxious and restlessness. The patient's voice became hoarse and her neck began to hurt. After 20 to 30 minutes of vaccination, these symptoms dissipated to be followed by chills and itching on forearms and knees. It was reported that, a call was made to the pharmacy and the pharmacist had suggested to use BENADRYL. The patient took BENADRYL as treatment. On 23-Sep-2017, the following morning, the patient awoke with itchy, raised red rash under arm, which extended up to the inner arm and down towards breast. The patient also had tingling sensation in the arm down to fingers, felt like three fingers with pins and needles (middle thru pinkie fingers). As the day progressed, rash became painful, stinging more than itching. Around 8:00 PM, the patient's tongue began burning appeared like a lime sunburn or exposed to excess citric acid. On the next day (24-Sep-2017), the patient went to urgent care where the doctor believed that the rash might be shingles. However, Stevens-Johnson syndrome [SJS] was not ruled out. The doctor did not explain anything about burning mouth. The condition persisted for 48 hours followed by vaccination. On 24-Sep-2017, unspecified lab examinations were performed (results not available). At the time of this report, the patient had not yet recovered from the events.
Sex: U
Vaccine: FLUC4
Symptoms: Dermatitis allergic, Injection site reaction, Rash
Clinical narrative: This serious spontaneous case, reported by healthcare professional (other) to VAERS and initially retrieved on 11-Jun-2018 by Seqirus from VAERS (VAERS ID: 714901), concerns a 51-year-old, adult, patient of unspecified gender. The patient was allergic to strawberries (since an unspecified date). The patient's current illness, historical conditions and concomitant medications were not reported. On 20-Sep-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml [reported as unk], route of administration: intramuscular, anatomical location: left arm, batch number: 195210A, expiry date: not reported). On 21-Sep-2017, 1 day after vaccination, the patient experienced allergic type of rash at the injection site, on neck and trunk. It was reported that rash lasted for 2 days. At the time of this report, the patient had recovered from the event.
Age: 26.0
Sex: F
Vaccine: FLUC4
Symptoms: Chest discomfort, Dizziness, Dyspnoea, Heart rate increased, Urticaria
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 16-Aug-2018 by Seqirus from VAERS (VAERS ID: 719484), concerns a 26-year-old, adult, female patient. The patient's historical procedure included pacemaker insertion and shoulder surgery (on an unspecified date). It was reported that, the patient was recovering from shoulder surgery. The patient's historical condition included connective tissue disease (since an unspecified date). The patient was allergic to penicillin (reported as PCN) amoxicillin (reported as Amox), nuts, bee sting and opiates. The patient's concomitant medications included PAXIL, WELLBUTRIN XL, gabapentin, LEVSIN and Trazodone for unknown indications. On 08-Oct-2017, the patient was administered FLUCELVAX QIV [dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number: 195212 and expiry date: not reported]. On the same day, 05 minutes after vaccination, the patient experienced dizziness, increased heart rate, shortness of breath, chest tightness, urticaria on chest. The patient self-injected the EPIPEN. The patient was taken to the hospital by emergency medical technician (EMT) for anaphylaxis. The patient had an emergency room visit. It was reported that, the patient was in hospital for 1 day. At the time of this report, the patient had recovered from the event. The reporter assessed the case as serious (hospitalization).
Age: 22.0
Sex: F
Vaccine: FLUC4
Symptoms: Anaphylactic reaction, Hypersensitivity
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 26-Aug-2018 by Seqirus from VAERS (VAERS ID: 728624), concerning a 22-year-old, adult, female patient. The patient's historical condition, current illness and concomitant medications were unknown. The patient was allergic to penicillin. On 20-Nov-2017, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml (frequency reported as 4), route of administration: intramuscular, anatomical location: left arm, batch number: 195248 and expiry date: not reported). On the same day, after vaccination, the patient developed an allergic reaction. On an unspecified date, the patient had made an emergency room and physician office visit. At the time of the report, the patient had recovered from the event. The reporter assessed the case as serious (life-threatening).
Sex: F
Vaccine: VARZOS
Symptoms: Anaphylactic shock
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of anaphylactic shock in a 60-year-old female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, 3 min after receiving SHINGRIX, the patient experienced anaphylactic shock (serious criteria GSK medically significant). The patient was treated with epinephrine. On an unknown date, the outcome of the anaphylactic shock was unknown. The reporter considered the anaphylactic shock to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. Anaphylactic shock epinephrine injection was provided. The reporter did feel it was related to the SHINGRIX and also stated that the emergency room physician also thought it was probably related to SHINGRIX. The pharmacist gave consent for follow up contact.
Sex: M
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Loss of personal independence in daily activities, Musculoskeletal pain, Pain in extremity
Clinical narrative: This case was reported by a consumer and described the occurrence of pain in arm in a male patient who received FLUARIX TETRA 2018-2019 season (batch number Y53NN, expiry date 30th June 2019) for prophylaxis. On 26th October 2018, the patient received FLUARIX TETRA 2018-2019 season. On 26th October 2018, immediately after receiving FLUARIX TETRA 2018-2019 season, the patient experienced pain in arm, shoulder pain, injected limb mobility decreased and activities of daily living impaired. On an unknown date, the outcome of the pain in arm, shoulder pain, injected limb mobility decreased and activities of daily living impaired were not recovered/not resolved. It was unknown if the reporter considered the pain in arm, shoulder pain, injected limb mobility decreased and activities of daily living impaired to be related to FLUARIX TETRA 2018-2019 season. Additional details were provided as follows: The age at vaccination was not reported. It was reported that the pharmacist was at school where the patient works administering the vaccine. Almost immediately after vaccination the patient experienced pain in his left arm and shoulder. It had now been several months and he continued to experience pain, it was hard to lift his arm or perform daily tasks. It was not clear if he had sought any medical treatment or not.
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Loss of personal independence in daily activities, Musculoskeletal pain, Pain in extremity
Clinical narrative: This case was reported by a consumer and described the occurrence of pain in arm in a female patient who received FLUARIX TETRA 2018-2019 season (batch number Y53NN, expiry date 30th June 2019) for prophylaxis. On 26th October 2018, the patient received FLUARIX TETRA 2018-2019 season. On 26th October 2018, 30 min after receiving FLUARIX TETRA 2018-2019 season, the patient experienced pain in arm and shoulder pain. On an unknown date, the patient experienced injected limb mobility decreased and activities of daily living impaired. On an unknown date, the outcome of the pain in arm, shoulder pain, injected limb mobility decreased and activities of daily living impaired were not recovered/not resolved. It was unknown if the reporter considered the pain in arm, shoulder pain, injected limb mobility decreased and activities of daily living impaired to be related to FLUARIX TETRA  2018-2019 season. Additional details were provided as follows: The age at vaccination was not reported. It was reported that the pharmacist from the right aid location was at school where the patient works administering the vaccine. Approximately 30 minutes after vaccination the patient experienced pain in her left arm and shoulder. It had now been several months and she continued to experience pain, it was hard to lift her arm or perform daily tasks. It was not clear if she had sought any medical treatment or not.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Contusion, Pain in extremity, Peripheral swelling, Skin discolouration
Clinical narrative: This case was reported by a consumer and described the occurrence of injection site swelling in a female patient who received SHINGRIX for prophylaxis. On 27th December 2018, the patient received the 1st dose of SHINGRIX. On 14th January 2019, 18 days after receiving SHINGRIX, the patient experienced injection site discoloration and injection site bruising. On an unknown date, the patient experienced injection site swelling. On an unknown date, the outcome of the injection site swelling was recovered/resolved and the outcome of the injection site discoloration and injection site bruising were not recovered/not resolved. It was unknown if the reporter considered the injection site swelling, injection site discoloration and injection site bruising to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient on the date of reporting got this really dark bruise. It did swell for about a week after the patient got the SHINGRIX shot but the bruise remained.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site bruising, Injection site discolouration, Injection site swelling
Clinical narrative: This case was reported by a consumer and described the occurrence of injection site swelling in a female patient who received SHINGRIX for prophylaxis. On 27th December 2018, the patient received the 1st dose of SHINGRIX. On 14th January 2019, 18 days after receiving SHINGRIX, the patient experienced injection site discoloration and injection site bruising. On an unknown date, the patient experienced injection site swelling. On an unknown date, the outcome of the injection site swelling was recovered/resolved and the outcome of the injection site discoloration and injection site bruising were not recovered/not resolved. It was unknown if the reporter considered the injection site swelling, injection site discoloration and injection site bruising to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient on the date of reporting got this really dark bruise. It did swell for about a week after the patient got the SHINGRIX shot but the bruise remained.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Neuralgia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of nerve pain in a 68-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (received 1st dose of SHINGRIX on 6th October 2018 with no events). On 30th November 2018, the patient received the 2nd dose of SHINGRIX. On 30th November 2018, unknown after receiving SHINGRIX, the patient experienced drug dose administration interval too short. On an unknown date, the patient experienced nerve pain. On an unknown date, the outcome of the nerve pain was not recovered/not resolved and the outcome of the drug dose administration interval too short was unknown. It was unknown if the reporter considered the nerve pain to be related to SHINGRIX. Additional details were provided as follows: The patient received 2nd dose of SHINGRIX 5 days early than the recommended schedule which led to, shortening of vaccination schedule. The patient was experiencing nerve pain under the arm and onto her back. The reporter gave consent to follow up.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Inappropriate schedule of product administration, Neuralgia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of nerve pain in a 68-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (received 1st dose of SHINGRIX on 6th October 2018 with no events). On 30th November 2018, the patient received the 2nd dose of SHINGRIX. On 30th November 2018, unknown after receiving SHINGRIX, the patient experienced drug dose administration interval too short. On an unknown date, the patient experienced nerve pain. On an unknown date, the outcome of the nerve pain was not recovered/not resolved and the outcome of the drug dose administration interval too short was unknown. It was unknown if the reporter considered the nerve pain to be related to SHINGRIX. Additional details were provided as follows: The patient received 2nd dose of SHINGRIX 5 days early than the recommended schedule which led to, shortening of vaccination schedule. The patient was experiencing nerve pain under the arm and onto her back. The reporter gave consent to follow up.
Age: 11.0
Sex: M
Vaccine: MMR, MNQ
Symptoms: Biopsy bone marrow abnormal, Contusion, Differential white blood cell count, Epistaxis, Full blood count
Clinical narrative: 10/16/18 -mother noticed easily bruising and disproportionate bruising and bloody noses that took 20 minutes to clot. Took pt to PCP. Bruising stated in the beginning of 7th grade school year sometime in early August. Pt had no other symptoms that mother noticed. CBC showed platelets of 5,000.   10/16-18 / 2018 Hospitalized and given IVIG treatment. 11/2018 -Diagnosed with ITP (idiopathic thrombocytopenia purpura) after bone marrow biopsy.
Age: 11.0
Sex: M
Vaccine: MMR, MNQ
Symptoms: Immune thrombocytopenic purpura, Immunoglobulin therapy, Increased tendency to bruise, Platelet count decreased
Clinical narrative: 10/16/18 -mother noticed easily bruising and disproportionate bruising and bloody noses that took 20 minutes to clot. Took pt to PCP. Bruising stated in the beginning of 7th grade school year sometime in early August. Pt had no other symptoms that mother noticed. CBC showed platelets of 5,000.   10/16-18 / 2018 Hospitalized and given IVIG treatment. 11/2018 -Diagnosed with ITP (idiopathic thrombocytopenia purpura) after bone marrow biopsy.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Myalgia, Nausea, Pyrexia
Clinical narrative: Fever, shivers, nausea, muscle aches.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Atrial fibrillation, Blood test, Cardiac stress test, Chest X-ray, Chills
Clinical narrative: 11/19-tingliness and numbness of left fingers, hand, arm, face and mouth drop, HBP and pulse. 11/20-21 - lightheaded, weakness of legs. 11/21-Visited ER. 11/22-27 - lightheaded, grabbing sensation on left forearm and bicep (steady) and alternate (same symptoms) in right arm. 11/28-12/6 - sporadic grabbing sensation on both arms, heaviness on left arm, air shots on right back side of the head; atrial fibrillation, chills. 12/7-1/3 - loss of appetite, atrial fibrillation, lightheaded (on/off), left arm: numbness of fingers, forearm, sensitivity to sunlight, tingling on back of head. 1/4-present- grabbing and pressure sensation of left arm, tingling of back of the head, atrial fibrillation.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Computerised tomogram head, Decreased appetite, Discomfort, Dizziness, Echocardiogram
Clinical narrative: 11/19-tingliness and numbness of left fingers, hand, arm, face and mouth drop, HBP and pulse. 11/20-21 - lightheaded, weakness of legs. 11/21-Visited ER. 11/22-27 - lightheaded, grabbing sensation on left forearm and bicep (steady) and alternate (same symptoms) in right arm. 11/28-12/6 - sporadic grabbing sensation on both arms, heaviness on left arm, air shots on right back side of the head; atrial fibrillation, chills. 12/7-1/3 - loss of appetite, atrial fibrillation, lightheaded (on/off), left arm: numbness of fingers, forearm, sensitivity to sunlight, tingling on back of head. 1/4-present- grabbing and pressure sensation of left arm, tingling of back of the head, atrial fibrillation.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Electrocardiogram, Electrocardiogram ambulatory, Facial paralysis, Heart rate increased, Hypertension
Clinical narrative: 11/19-tingliness and numbness of left fingers, hand, arm, face and mouth drop, HBP and pulse. 11/20-21 - lightheaded, weakness of legs. 11/21-Visited ER. 11/22-27 - lightheaded, grabbing sensation on left forearm and bicep (steady) and alternate (same symptoms) in right arm. 11/28-12/6 - sporadic grabbing sensation on both arms, heaviness on left arm, air shots on right back side of the head; atrial fibrillation, chills. 12/7-1/3 - loss of appetite, atrial fibrillation, lightheaded (on/off), left arm: numbness of fingers, forearm, sensitivity to sunlight, tingling on back of head. 1/4-present- grabbing and pressure sensation of left arm, tingling of back of the head, atrial fibrillation.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia, Limb discomfort, Muscular weakness, Nuclear magnetic resonance imaging, Nuclear magnetic resonance imaging spinal
Clinical narrative: 11/19-tingliness and numbness of left fingers, hand, arm, face and mouth drop, HBP and pulse. 11/20-21 - lightheaded, weakness of legs. 11/21-Visited ER. 11/22-27 - lightheaded, grabbing sensation on left forearm and bicep (steady) and alternate (same symptoms) in right arm. 11/28-12/6 - sporadic grabbing sensation on both arms, heaviness on left arm, air shots on right back side of the head; atrial fibrillation, chills. 12/7-1/3 - loss of appetite, atrial fibrillation, lightheaded (on/off), left arm: numbness of fingers, forearm, sensitivity to sunlight, tingling on back of head. 1/4-present- grabbing and pressure sensation of left arm, tingling of back of the head, atrial fibrillation.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Paraesthesia, Photophobia, Sensory disturbance
Clinical narrative: 11/19-tingliness and numbness of left fingers, hand, arm, face and mouth drop, HBP and pulse. 11/20-21 - lightheaded, weakness of legs. 11/21-Visited ER. 11/22-27 - lightheaded, grabbing sensation on left forearm and bicep (steady) and alternate (same symptoms) in right arm. 11/28-12/6 - sporadic grabbing sensation on both arms, heaviness on left arm, air shots on right back side of the head; atrial fibrillation, chills. 12/7-1/3 - loss of appetite, atrial fibrillation, lightheaded (on/off), left arm: numbness of fingers, forearm, sensitivity to sunlight, tingling on back of head. 1/4-present- grabbing and pressure sensation of left arm, tingling of back of the head, atrial fibrillation.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Abdominal X-ray, Blood test, Decreased appetite, Diarrhoea haemorrhagic, Irritability
Clinical narrative: 24 hours later bloody diarrhea and occurred a few times with fussiness and decreased appetite.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Stool analysis, Ultrasound abdomen
Clinical narrative: 24 hours later bloody diarrhea and occurred a few times with fussiness and decreased appetite.
Sex: F
Vaccine: MMR
Symptoms: Rubella antibody negative
Clinical narrative: This spontaneous prospective pregnancy report was received from a Licensed Practical Nurse, and refers to a female patient of unknown age. The patient's concurrent conditions, drug reactions/allergies, concomitant medications and historical conditions were unknown by the reporter. On an unknown date, the patient was vaccinated with M-M-R II for prophylaxis (route of administration, anatomical location, lot number and expiration date were not provided). On an unknown date, the patient had low rubella antibodies, for which it was unknown if she received any treatment. On approximately 07-SEP-2018 (reported as "the patient was 18 weeks pregnant"), the patient became pregnant (last menstrual period was estimated to be on 24-AUG-2018 and date of delivery was calculated to be on 31-MAY-2019). It was unknown if laboratory tests were carried out. The outcome of low rubella antibodies was unknown. Pregnancy outcome was pending. Causality assessment was not provided.
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-009507513-1901USA002589:
Age: 3.0
Sex: U
Vaccine: MMR
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 3-year-old patient. The patient's medical history, concomitant medications and drug reactions or allergies were not reported. On 14-SEP-2016, the 20-month-old patient, was vaccinated with the first dose of M-M-R II (strength, dose, route of administration and lot # with expiration date were not reported) as prophylaxis. On 07-MAR-2018, the patient, who was at that time 38 months old, was vaccinated with the second dose of M-M-R II (strength, dose, route of administration and lot # with expiration date were not reported) as prophylaxis. No adverse effects were reported. The outcome of inappropriate schedule of product administration was unknown.
Sex: F
Vaccine: PPV
Symptoms: Injection site discharge, Injection site pustule, Injection site swelling
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 50 year old female patient. The patient's pertinent medical history included a lot of unspecified medical issues. Information on patient's concomitant medications was not reported. On an unknown date, few months ago, the patient was vaccinated with PNEUMOVAX 23 (1 injection)(route, frequency, lot and expiry date were unknown) for dyspnea. On an unknown date, about a week later, the patient experienced unusual swelling and puss coming from the injection site(vaccination site swelling and vaccination site pustule). " No additional AE information provided". Outcome of vaccination site swelling and vaccination site pustule was unknown. Causality assessment was not provided.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received on 15-JAN-2019 regarding a case in litigation from a lawyer concerning a female patient of unknown age. There was no information provided regarding the patient's concurrent conditions, medical history or concomitant medications. The patient was prescribed the ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 12-MAR-2007, the patient was administered the ZOSTAVAX (lot number, expiration, dose and route unknown) by a healthcare provider at a county health department. On or about 07-AUG-2012, the patient was treated by a healthcare provider at an eye care center for the following injuries resulting from the patient's ZOSTAVAX use: herpes zoster. The patient claims damages as a result of injury to herself and economic losses. The outcome of the event is unknown. The causality of the event is related. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received regarding a case in litigation from a lawyer and a 61-year old patient (gender unknown) referring to himself or herself. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX vaccine by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 01-NOV-2015, the patient was administered the ZOSTAVAX by a physician at a physician's office (lot number, dosage and route of administration not provided). On or about 02-NOV-2015, the patient was treated by a physician at the physician's office (same physician who administered vaccine to patient) for the following injury resulting from the ZOSTAVAX use: Shingles. The patient claims damages including: injury to themselves, loss of consortium, loss of services, and economic losses. The outcome of the shingles was unknown. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation concerning an approximately 71 year old female patient. Information regarding medical history, concurrent conditions, and concomitant medication use was not provided. The patient was prescribed ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. In April 2009 (patient was approximately 63 years old at this time), the patient was administered ZOSTAVAX by a pharmacist (lot # and route unknown). On or about 13-APR-2017 (patient was approximately 71 years old at this time), the patient was treated by a physician at a medical group for the following injuries resulting from the patient's ZOSTAVAX use: shingles. The outcome of the event was unknown. 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 female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX vaccine by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 02-JUN-2008, the patient was administered the ZOSTAVAX by a physician (lot number, dosage and route of administration not provided). On an unknown date in 2017, the patient was treated by a healthcare provider for the following injury resulting from her ZOSTAVAX use: Shingles. The patient claims damages including: injury to herself and economic losses. The outcome of the shingles is unknown. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received regarding a case in litigation from a lawyer, a 73 year old female patient and her spouse. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX vaccine by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 26-JAN-2013, the 69 year old female patient was administered the ZOSTAVAX by a pharmacist at a pharmacy (lot number, dosage and route of administration not provided). On or about 15-MAR-2017, the patient was treated by a physician for the following injury resulting from her ZOSTAVAX use: Shingles. The patient claims damages including: injury to themselves, loss of consortium, loss of services, and economic losses. The outcome of the shingles is unknown. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: Initial Report Received: 26-Dec-2018 A physician reported that patient CU, a 52-year-old female patient (race not provided) was administered with HEPLISAV-B which was stored improperly for approximately 5 days. Relevant medical history was not provided.  The patient had no known allergies. Concomitant medications were not provided. On 26-Dec-2018, the patient received a dose of HEPLISAV-B (lot # 1036463, expiration date 28-Jul-2019) in the left deltoid, which was stored improperly. It was stored out of temperature range for greater than 8 hours, for approximately 5 days. The patient reported no adverse reactions. No further information was provided. The reporter did not provide a seriousness assessment for the event. Company comment: The company assessed the event of improper storage of product in use as non-serious. The event of improper storage of product in use is unlisted per HEPLISAV-B; Sender's Comments: The company assessed the event of improper storage of product in use as non-serious. The event of improper storage of product in use is unlisted per HEPLISAV-B.
Sex: F
Vaccine: MENB
Symptoms: Ill-defined disorder, Malaise
Clinical narrative: This case was reported by a consumer and described the occurrence of sickness in a female patient who received BEXSERO for prophylaxis. In September 2018, the patient received the 1st dose of BEXSERO. On an unknown date, less than a year after receiving BEXSERO, the patient experienced sickness and illness. On an unknown date, the outcome of the sickness and illness were unknown.  It was unknown if the reporter considered the sickness and illness to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. It was reported that was there any timeframe that the 2nd dose of BEXSERO could no longer be received as the patient got her 1st dose of BEXSERO in September and was very sick and did not end up getting 2nd injections due to illness. The reporter asked if she could receive the 2nd dose and get it covered or had to restart the injections and what was the last possible date to get an injection and it if it would still counted as part of the series. This case has been linked to the case US2019GSK010398 (second daughter), reported by same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Feeling cold, Immobile, Incomplete course of vaccination, Middle insomnia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of immobile in a patient who received SHINGRIX for prophylaxis. On 26th October 2018, the patient received the 1st dose of SHINGRIX. In October 2018, less than a day after receiving SHINGRIX, the patient experienced shivering and feeling cold. On an unknown date, the patient experienced immobile (serious criteria GSK medically significant) and nocturnal awakening. SHINGRIX was discontinued. On an unknown date, the outcome of the immobile was recovered/resolved and the outcome of the shivering, feeling cold and nocturnal awakening were unknown. It was unknown if the reporter considered the immobile, shivering, feeling cold and nocturnal awakening to be related to SHINGRIX. Additional details were received as follows: This case was received via phone. The age at vaccination was not reported or this report. The patient was told by the pharmacist to report. After vaccination with Shingles vaccine, the patient was not able to move for 3 days. In the middle of the night, the patient woke up in the middle of the night with shivering and freezing. The patient reported, these events were horrible. The patient never had a reaction to anything unlike this. The patient was not going to take 2nd shot of Shingles vaccine because of this.
Sex: M
Vaccine: TDAP
Symptoms: Insomnia, Limb discomfort, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in upper extremities in a adult male patient who received BOOSTRIX for prophylaxis. The patient's past medical history included gallbladder removal (gallbladder had been removed in 1999). Previously administered products included Tetanus with an associated reaction of pain (received in his 40's and had slight pain). On 14th December 2018, the patient received BOOSTRIX (intramuscular) .5 ml. On 16th December 2018, 2 days after receiving BOOSTRIX, the patient experienced pain in upper extremities. The patient was treated with ibuprofen. On an unknown date, the outcome of the pain in upper extremities was not recovered/not resolved. It was unknown if the reporter considered the pain in upper extremities to be related to BOOSTRIX. Additional details were provided as follows: The age at vaccination was not reported, but the patient was in his 50's. The patient did not have any allergies. The patient received BOOSTRIX on upper left arm (left deltoid). The patient was experiencing excruciating pain in left arm and had continued to have the pain. The patient was experiencing severe excruciating pain in left arm and had continued to have the pain. It was reported that the patient was not able to sleep because he could not get his arm comfortable. He had tried multiple means, including ibuprofen, percussion massage, electronic simulation, exercise and nothing had helped him with the pain. The patient believed there was an issue with the lot of BOOSTRIX. There was no product available for return and no replacement of the product or reimbursement was requested at that time. The patient did not receive any other vaccines on the same day or 4 weeks prior to receiving BOOSTRIX. The patient's physician stated that he had a very high tolerance to pain. But this event was excruciating. He stated that he was overdosing on Ibuprofen trying to get relief.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Fatigue, Influenza like illness, Injection site pain
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of feeling unwell in a 64-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included ZOSTAVAX (4 years ago). On 23rd December 2018, the patient received SHINGRIX (intramuscular) .5 ml. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced feeling unwell, chills, tremor, fever, energy decreased, fatigue, influenza-like symptoms and injection site tenderness. The patient was treated with naproxen. On an unknown date, the outcome of the feeling unwell, chills, tremor, fever, energy decreased, fatigue, influenza-like symptoms and injection site tenderness were recovered/resolved. It was unknown if the reporter considered the feeling unwell, chills, tremor, fever, energy decreased, fatigue, influenza-like symptoms and injection site tenderness to be related to SHINGRIX. Additional details were provided as follows: This case was reported by a Nurse Practitioner (NP) who herself was a patient. The patient had received ZOSTAVAX 4 years ago when she was 60. The patient stated they were she was not feeling well after administration of SHINGRIX in the left deltoid. The patient experienced chills, shaking, low grade fever (100.5 degree F), low energy, malaise, fatigue, flu like symptoms. The patient also had local site tenderness. The patient took Naproxen did not seek additional care outside of self-treatment, as she was a Nurse Practitioner. All symptoms lasted about 4 days and did not anticipate them to be this severe. Low energy level lasted longer. At the time of this report, the patient was feeling like she was getting back to normal. The reporter agreed to follow up.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Pyrexia, Tremor
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of feeling unwell in a 64-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included ZOSTAVAX (4 years ago). On 23rd December 2018, the patient received SHINGRIX (intramuscular) .5 ml. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced feeling unwell, chills, tremor, fever, energy decreased, fatigue, influenza-like symptoms and injection site tenderness. The patient was treated with naproxen. On an unknown date, the outcome of the feeling unwell, chills, tremor, fever, energy decreased, fatigue, influenza-like symptoms and injection site tenderness were recovered/resolved. It was unknown if the reporter considered the feeling unwell, chills, tremor, fever, energy decreased, fatigue, influenza-like symptoms and injection site tenderness to be related to SHINGRIX. Additional details were provided as follows: This case was reported by a Nurse Practitioner (NP) who herself was a patient. The patient had received ZOSTAVAX 4 years ago when she was 60. The patient stated they were she was not feeling well after administration of SHINGRIX in the left deltoid. The patient experienced chills, shaking, low grade fever (100.5 degree F), low energy, malaise, fatigue, flu like symptoms. The patient also had local site tenderness. The patient took Naproxen did not seek additional care outside of self-treatment, as she was a Nurse Practitioner. All symptoms lasted about 4 days and did not anticipate them to be this severe. Low energy level lasted longer. At the time of this report, the patient was feeling like she was getting back to normal. The reporter agreed to follow up.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster, Post herpetic neuralgia, Vaccination failure
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of vaccination failure in a male patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included post herpetic neuralgia and shingles (3 months ago before the date of reporting). On 7th January 2019, the patient received SHINGRIX. In January 2019, less than a week after receiving SHINGRIX, the patient experienced vaccination failure (serious criteria GSK medically significant), post herpetic neuralgia, shingles and condition aggravated. On an unknown date, the outcome of the vaccination failure, post herpetic neuralgia, shingles and condition aggravated were unknown. It was unknown if the reporter considered the vaccination failure, post herpetic neuralgia, shingles and condition aggravated to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported however; the patient age could be around 70 to 72 years. The patient received SHINGRIX vaccine and felt that his post herpetic neuralgia was worse now following receipt of the vaccine. This case was considered as suspected vaccination failure as time to onset for the event, details regarding vaccination schedule was unknown.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site rash
Clinical narrative: This case was reported by a consumer and described the occurrence of injection site rash in a 77-year-old male patient who received SHINGRIX (batch number 5MG5E, expiry date unknown) for prophylaxis. On 3rd December 2018, the patient received the 1st dose of SHINGRIX. In December 2018, less than a day after receiving SHINGRIX, the patient experienced injection site rash and injection site itching. On an unknown date, the outcome of the injection site rash and injection site itching were recovered/resolved. It was unknown if the reporter considered the injection site rash and injection site itching to be related to SHINGRIX. Additional details were provided as follows: The patient received a dose of SHINGRIX and had a rash below where the patient had received the vaccine it was about 3 inch long and 2 inch high. The rash was also a bit itchy. The rash lasted about 2 weeks it slowly went away. The patient went to her physician several days after the rash started and he suggested that the patient should report it to GlaxoSmithKline. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Axillary pain, Breast pain, Inappropriate schedule of product administration, Pain
Clinical narrative: This case was reported by a nurse and described the occurrence of radiating pain in a female patient who received SHINGRIX for prophylaxis. Concomitant products included SHINGRIX. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced radiating pain and drug dose administration interval too short. On an unknown date, the outcome of the radiating pain and drug dose administration interval too short were unknown. It was unknown if the reporter considered the radiating pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient care of anecdotal evidence of pain radiating from armpit to breast. The reporter tried to do patient education but could not find that this type of pain was a known side effect of SHINGRIX, which began after 2nd dose given by pharmacy 35 days after 1st injection, which led to which led to the shortening of the vaccination schedule. The reporter seeking information you can provide so I can reassure patient symptoms were transient.
Sex: M
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster, Malaise, Off label use, Product use in unapproved indication
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shingles in a male patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included shingles. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced shingles, condition aggravated, feeling unwell, drug use for unapproved indication and off label use. On an unknown date, the outcome of the shingles, condition aggravated and feeling unwell were not recovered/not resolved and the outcome of the drug use for unapproved indication and off label use were unknown. It was unknown if the reporter considered the shingles, condition aggravated and feeling unwell to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient was vaccinated with SHINGRIX by his health care provider in the middle of a case of Shingles, while the infection was still active. The health care provider was wondering why it was recommended to patient who had an outbreak of shingles, which led to drug use for unapproved indication and off label use. The patient has ongoing side effects after becoming very ill in the two days after the immunization.