chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Hypoaesthesia, Muscle spasms, Sciatica
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. In or around 16-JUL-2015, the patient received the ZOSTAVAX (lot number, dosage and route of administration not provided) for its intended purpose: the prevention of shingles. On an unknown date (reported as "shortly thereafter"), the patient started experiencing sciatic pain, numbness in the right leg and hands, cramping, and mild headaches. In or around May 2016, the patient presented to a physician for these injuries. As a direct and proximate result of the ZOSTAVAX, the patient's symptoms have resulted in physical limitations not present prior to using the ZOSTAVAX. The patient also experiences mental and emotional distress due to the resulting physical conditions and the seriousness of her condition. As a result, the patient sustained severe and lasting personal injuries. Further as a tragic consequence, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate consequence of ZOSTAVAX, the patient sustained serious personal injuries and related losses including but not limited to, the following: the patient required and will continue to require healthcare and services; the patient incurred and will continue to incur medical and related expenses; and the patient suffered and will continue to suffer mental anguish, physical pain and suffering, diminished capacity for the enjoyment of life, a diminished quality of life, and other losses and damages. The outcome of the events was considered to be not recovered. Sciatic pain, numbness in the right leg and hands, cramping and headaches were considered to be disabling. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Loss of consciousness, Syncope
Clinical narrative: This spontaneous report was received from a nurse and refers to a 12 year old male patient. It was reported that the patient does not have any pertinent medical history, drug reaction or allergies and does not use any concomitant medication. On an unknown date in December 2018 (reported as one week or two weeks ago), the patient was administered with GARDASIL 9 for prophylaxis (reported as vaccination) (dose, dose number, route, lot#, expiry date unspecified). On the same day, after vaccination the patient waited in office for observation for 15 minutes and no adverse reaction occurred. However, on the way to home the patient experienced syncope and passed out (loss of consciousness) in the car. No treatment was provided for the events. The outcome of syncope and loss of consciousness was reported as recovered (also reported as fine now). Causality assessment was not provided by the reporter. Upon internal review, syncope and loss of consciousness were determined to be medically significant.
Age: 61.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash vesicular
Clinical narrative: This spontaneous report was received from a registered nurse, concerning a 61 year old female patient. The patient's pertinent medical history, concurrent conditions, drug reactions, allergies and concomitant medications were not provided. On 22-OCT-2018, the patient was vaccinated with the first dose of VARIVAX subcutaneously for prophylaxis, lot #N030406 and expiration date 30-OCT-2019 (strength, dose and frequency was not provided). On 26-OCT-2018, the patient developed varicella-like rash on her hands, legs and bottoms of her feet. The patient called her physician and did not receive any treatment for the event. The nurse could not confirm if the rash was a post-vaccination rash caused by the vaccine virus or whether the rash was indicative of disseminated varicella caused by wild-type virus, therefore a VZVIP was faxed. At the time of reporting, the patient recovered from varicella-like rash on her hands, legs and bottoms of her feet. The causal relationship between the vaccination with VARIVAX and the event was not provided by the reporting nurse.
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Pneumonia
Clinical narrative: This case was reported by a consumer via patient support programs and described the occurrence of pneumonia in a 73-year-old male patient who received Flu unspecified (Influenza vaccine) for prophylaxis. Concurrent medical conditions included chronic obstructive pulmonary disease. Concomitant products included fluticasone propionate, salmeterol xinafoate (Advair) and salbutamol sulphate (Ventolin Hfa). 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 pneumonia (serious criteria hospitalization and GSK medically significant). On an unknown date, the outcome of the pneumonia was unknown. It was unknown if the reporter considered the pneumonia to be related to Influenza vaccine. Additional information received as follows: The patient stated that he came out from the hospital due to getting the flu shot and he caught pneumonia. This is 1 of the 3 linked cases reported for the same patient.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Adverse event
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of adverse event in a 58-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (no adverse events). On 2nd January 2019, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced adverse event. 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 provided as follows: The age at vaccination was not reported. In January 2019, after receiving the vaccine, the patient seem to be having all the symptoms on website (not specified). The reporter asking how long would the side effects last. The patient received the vaccine from local pharmacy and no prescriber.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain, Product supply issue
Clinical narrative: This case was reported by a consumer and described the occurrence of injection site pain in a adult patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. On 25th October 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced injection site pain and product supply issue. On an unknown date, the outcome of the injection site pain and product supply issue were unknown. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient asked that could GlaxoSmithKline (GSK) provide any guidance on how the get the second dose of SHINGRIX. The patient received first shot on 25th October 2018 and was told by there pharmacy the second shot would be put aside for the patient for an appointment scheduled for 4th january 2019 (well within the 2 to 6 month window). However, the patient just found out last minute the pharmacy gave other dose away and at the time of reporting, the patient left hanging as to and asked how to get the second dose within the necessary timeframe. And, said the only option that pharmacy offer them was for to call the patient every week to have them look for inventory within a 50 to100 miles radius. The patient asked that was there anything GSK can do to help someone who has had the initial dose already so that the did not have to go through both shots again, Especially since the patient had the typical soreness from the first shot.
Sex: F
Vaccine: FLU4
Symptoms: H1N1 influenza, Influenza A virus test positive, Vaccination failure
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of suspected vaccination failure in an unspecified number of patients who received FLUARIX QUADRIVALENT 2018-2019 season for prophylaxis. On an unknown date, the patients received FLUARIX QUADRIVALENT 2018-2019 season at an unknown dose. On an unknown date, less than a year after receiving FLUARIX QUADRIVALENT 2018-2019 season, the patients experienced vaccination failure (serious criteria GSK medically significant) and h1n1 influenza. On an unknown date, the outcome of the vaccination failure and h1n1 influenza were unknown. It was unknown if the reporter considered the vaccination failure and h1n1 influenza to be related to FLUARIX QUADRIVALENT 2018-2019 season. Additional information received as follows: The age at vaccination was not applicable for this report. The pharmacist stated that they vaccinated patients with FLUARIX QIV 2018-2019 year and many of the patients got the flu caused by H1N1 strain. However, the healthcare professional did not have the specific strain of H1N1 just that the influenza virus some patients contracted was from H1N1 (but healthcare professional did not have the specific H1N1 strains of flu these patients got). The healthcare professional unsure if a lack of effect from FLUARIX, or if the H1N1 strain of influenza these patients contracted was not contained in 2018-2019 years flu vaccine. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization and time to onset for flu was not provided. The reporter did not consent to follow-up. Lab Comments: On an unknown date the patients were positive for H1N1 strain of influenza.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Ear pain, Headache, Incorrect route of product administration, Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced injection site pain, injection site swelling, lymphadenopathy cervical, ear pain, chills, fever, heart pounding, headache, blurred vision and intramuscular formulation administered by other route. The patient was treated with prednisone, sudafed (nos) (Sudafed) and antibiotics nos (Antibiotics (Brand Names Not Known)). On an unknown date, the outcome of the injection site pain, lymphadenopathy cervical and ear pain were not recovered/not resolved and the outcome of the injection site swelling, chills, fever, heart pounding, headache and blurred vision were recovered/resolved and the outcome of the intramuscular formulation administered by other route was unknown. It was unknown if the reporter considered the injection site pain, injection site swelling, lymphadenopathy cervical, ear pain, chills, fever, heart pounding, headache and blurred vision to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported, but the age group was captured adult as per vaccine indication. The patient reports her first dose of Shingrix administered was inadvertently injected into the soft tissue of her arm as opposed to the muscle, which led to incorrect route of administered. The patient developed injection site pain and swelling, gland swelling in left side of neck along with ear pain and swelling, chills, fever of 101 for 5 days, heart pounding, headaches and blurry vision. The patient was seen by her nurse practitioner who treated her with antibiotics, prednisone and Sudafed. At the time of this report all symptoms resolved aside from injection site tenderness, neck gland swelling and ear pain. Lab Comments: lab test performed on an unknown date.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Lymphadenopathy, Palpitations, Pyrexia, Vision blurred
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced injection site pain, injection site swelling, lymphadenopathy cervical, ear pain, chills, fever, heart pounding, headache, blurred vision and intramuscular formulation administered by other route. The patient was treated with prednisone, sudafed (nos) (Sudafed) and antibiotics nos (Antibiotics (Brand Names Not Known)). On an unknown date, the outcome of the injection site pain, lymphadenopathy cervical and ear pain were not recovered/not resolved and the outcome of the injection site swelling, chills, fever, heart pounding, headache and blurred vision were recovered/resolved and the outcome of the intramuscular formulation administered by other route was unknown. It was unknown if the reporter considered the injection site pain, injection site swelling, lymphadenopathy cervical, ear pain, chills, fever, heart pounding, headache and blurred vision to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported, but the age group was captured adult as per vaccine indication. The patient reports her first dose of Shingrix administered was inadvertently injected into the soft tissue of her arm as opposed to the muscle, which led to incorrect route of administered. The patient developed injection site pain and swelling, gland swelling in left side of neck along with ear pain and swelling, chills, fever of 101 for 5 days, heart pounding, headaches and blurry vision. The patient was seen by her nurse practitioner who treated her with antibiotics, prednisone and Sudafed. At the time of this report all symptoms resolved aside from injection site tenderness, neck gland swelling and ear pain. Lab Comments: lab test performed on an unknown date.
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered, Injection site pain
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of injection site pain in a male patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose and the 3rd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced injection site pain, circumstance or information capable of leading to medication error and extra dose administered. On an unknown date, the outcome of the injection site pain, circumstance or information capable of leading to medication error and extra dose administered were unknown. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided as follows: The healthcare professional was also the consumer. The retired physician assistant stated that he had some local tenderness at injection site after SHINGRIX. In addition, the patient believed he already received 2 doses of SHINGRIX, however, patient stated that the doctor's office called him to come in for his 2nd dose of SHINGRIX; however, the patient already thought he got both doses of SHINGRIX; however, the doctor's office only had record of patient receiving their 1st dose of SHINGRIX, which led to circumstance or information capable of leading to medication error and extra dose administered. The patient was deciding whether to go in to get another dose of SHINGRIX, which the patient believed would be his 3rd dose of SHINGRIX, or, by the doctor's records, it would only be his 2nd dose of SHINGRIX since physician's office only had a record of 1 dose of SHINGRIX so far for this patient. The patient also did not wish to be contacted by patient safety. The patient did not consent to follow-up.
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, Therapeutic response decreased
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of therapeutic response decreased in a adult male patient who received ENGERIX B (batch number 4795H, expiry date 14th July 2020) for prophylaxis. Co-suspect products included ENGERIX B for prophylaxis and ENGERIX B for prophylaxis. On an unknown date, the patient received the 1st dose of ENGERIX B, the 2nd dose of ENGERIX B and the 3rd dose of ENGERIX B. On an unknown date, unknown after receiving ENGERIX B, ENGERIX B and ENGERIX B, the patient experienced therapeutic response decreased. On an unknown date, the outcome of the therapeutic response decreased was unknown. It was unknown if the reporter considered the therapeutic response decreased to be related to ENGERIX B, ENGERIX B and ENGERIX B. Additional details were provided as follows: The healthcare professional reported that after 3 dose series of ENGERIX B, the patient had low titres. The reporter gave consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site swelling and injection site muscle pain. On an unknown date, the outcome of the injection site swelling was recovering/resolving and the outcome of the injection site muscle pain was not recovered/not resolved. It was unknown if the reporter considered the injection site swelling and injection site muscle pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. One month ago the reporting, the patient received the 1st dose of SHINGRIX on left deltoid. After receiving the vaccine, the injection site was swollen for the few days and had improved at the time of reporting. Till the time of reporting, the patient still had muscle pain in her upper left arm when she flexes her arm. The patient was wondering that how long it would last. The patient was upset that the pharmacists give these shot and they did not tell that how painful they are. The patient was in doubt that she would get the second injection and wants reimbursement. The patient wanted to remain anonymous.
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, Therapy non-responder
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of therapy non-responder in a elderly female patient who received Hepatitis B vaccine for prophylaxis. On an unknown date, the patient received Hepatitis B vaccine at an unknown dose. In December 2018, 20 years after receiving Hepatitis B vaccine, the patient experienced therapy non-responder. On an unknown date, the outcome of the therapy non-responder was unknown. It was unknown if the reporter considered the therapy non-responder to be related to Hepatitis B vaccine. Additional details were provided as follows: The age at vaccination was not reported. The patient completed a series of Hepatitis B vaccines 20 years before the time of reporting. The healthcare professional was unsure if the patient completed Hepatitis B series with Engerix-B or a different manufacturer. The patient tested for Hepatitis B antibody, which was found to be Positive 20 years before the time of reporting. In December 2018, the antibody against Hepatitis B showed non-reactive, which led the patient to be a therapy non-responder. The reporter gave consent to follow up. Lab Comments: on an unknown date, 20 years before the time of reporting the Hepatitis B antibody tested positive for immunity.
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, Therapy non-responder
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of therapy non-responder in a female patient who received Hepatitis B vaccine for prophylaxis. On an unknown date, the patient received Hepatitis B vaccine at an unknown dose. On an unknown date, unknown after receiving Hepatitis B vaccine, the patient experienced therapy non-responder. On an unknown date, the outcome of the therapy non-responder was unknown. It was unknown if the reporter considered the therapy non-responder to be related to Hepatitis B vaccine. Additional details were provided as follows: The age at vaccination was not reported. The nurse stated that the patient who previously received a Hepatitis B series showed a non reactive titer to a recent blood test, which led to therapy non-responder. Lab Comments: On an unknown date hepatitis B antibody was measured.
Sex: F
Vaccine: FLUX
Symptoms: Caesarean section, Emergency care, Exposure during pregnancy, Foetal disorder
Clinical narrative: This is a prospective pregnancy case. This female subject was enrolled in a study to detect and describe any abnormal pregnancy outcomes in women intentionally or unintentionally vaccinated with either FLUARIX or FLUARIX QUADRIVALENT or FLULAVAL or FLULAVAL QUADRIVALENT during pregnancy or within 28 days preceding conception. The subject received Flu Seasonal QIV Dresden .5 ml on 1st October 2018, for prophylaxis. The subject received Flu Seasonal QIV Quebec .5 ml on 1st October 2018, for prophylaxis. The subject's estimated date of delivery was 2nd October 2018. The subject received Flu Seasonal QIV Dresden at week 40 of the pregnancy and during the third trimester of pregnancy. On an unknown date, unknown after receiving Flu Seasonal QIV Dresden and Flu Seasonal QIV Quebec, the subject developed vaccine exposure during pregnancy (Non-serious). The outcome of vaccine exposure during pregnancy was unknown. The pregnancy was ongoing. Additional details were provided as follows: The age at vaccination was not reported. The patient was 40 weeks pregnant and received flu shot, which led to vaccine exposure during pregnancy. The patient did not have lot number available and could not confirm if product was FLUARIX or FLULAVAL. The birth date and personal healthcare professional information was not obtained. The patient received flu shot at the clinic at the office where she worked. The patient did not ask for permission to follow up with healthcare professional. Follow up information received from a consumer on 2nd January 2019: On 26th December 2017, the patient had her last menstrual period (LMP). The expected due date of delivery was 2nd October 2018. The patient had 28 hours labor (date unspecified) due to which she had an emergency C-section and gave birth to a baby (details not reported). The baby had cord double wrapped around neck and heart rate went into the 60's for 7 minutes which was unnoticed by the medical staff. At the time of this report, the baby was healthy. It was unknown if the reporter considered the C- section to be related to the FLUARIX or FLULAVAL.
Sex: U
Vaccine: PPV
Symptoms: Allergy to vaccine, Pruritus, Urticaria
Clinical narrative: This is a spontaneous report from a contactable physician. A 69-year-old patient of an unspecified gender received pneumococcal 13-val conj vac (dipht crm197 protein) on an unspecified date at single dose for immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced allergy to pneumococcal 13-val conj vaccine, urticaria and itching. The outcome of the events was unknown. Pfizer is a marketing authorization holder of pneumococcal 13-val conj vac (dipht crm197 protein) in the reporter's country. This may be a duplicate report if another marketing authorization holder of pneumococcal 13-val conj vac (dipht crm197 protein) has submitted the same report to the regulatory authorities.
Age: 59.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site pain, Nuclear magnetic resonance imaging
Clinical narrative: Initial information received on 02-Jan-2019 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to case 2019SA003119 (FLUZONE QIV, same patient). This case involves a female patient (age not reported) who experienced left Shoulder pain, while she received vaccine INFLUENZA VACCINE. The patient's past medical treatment(s) and family history were not provided. At the time of the event, the patient's concurrent condition included Tobacco user. On 18-Oct-2018, the patient received dose of suspect INFLUENZA VACCINE (lot number, expiry date, route, was not reported) in her bursa of her left arm. On an unknown date, the patient developed a non serious Left Shoulder pain following the administration of INFLUENZA VACCINE. On an unknown date, the patient performed MRI. Final diagnosis was barely Left Shoulder pain. The outcome of the event was not reported.
Age: 12.0
Sex: M
Vaccine: FLU4
Symptoms: Expired product administered
Clinical narrative: Initial information received on 03-Jan-2019 regarding an unsolicited valid non-serious case received from non health professional. This case involves 12 year old male patient who received an 0.5 ml expired dose of vaccine FLUZONE QUADRIVALENT. (Batch number UI714AA, expiry date: 30-Jun-2017) via intramuscular route in the right deltoid 31 Dec 2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Patient did not received no other vaccines. It was a case of actual medication error due to expired vaccine used. It was not reported that if any adverse reaction was experienced. 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.
Sex: M
Vaccine: TD
Symptoms: Wrong product administered
Clinical narrative: Initial information received on 03-Jan-2019 regarding an unsolicited valid non-serious case received from a other health care professional. This case involves a 38 years old male patient who received a 0.5ml dose of TENIVAC (Batch number: U5882AA, expiration date: 08-Mar-2020, site of administration: left deltoid and route was not reported) on an unknown date. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to wrong vaccine administered. The nurse accidentally vaccinated the patient with TENIVAC instead of ADACEL. It was unknown whether patient experienced any adverse event following vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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. List of documents held by sender: none.
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Initial information received on 03-Jan-2019 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 44 years old female patient who experienced soreness in the right arm and having a hard time moving or lifting the arm, while she received vaccine FLUZONE QUADRIVALENT. The patient past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 17-Dec-2018, the patient received a 0.5ml dose of suspect Influenza Quadrival A-B Vaccine, lot UJ041AA, expiration date: 30-Jun-2019 via unknown route in the right deltoid. On an unknown date, the patient experienced a non-serious soreness in the right arm and having a hard time moving or lifting the arm (painful R arm) (Unknown latency) following the administration of Influenza Quadrival A-B Vaccine. (Other relevant tests included no lab data.) Final diagnosis was soreness in the right arm and having a hard time moving or lifting the arm. It was not reported if the patient received a corrective treatment. The patient outcome was not reported. List of documents held by sender: none.
Sex: M
Vaccine: FLU3
Symptoms: Injection site bruising, Injection site discolouration, Injection site erythema
Clinical narrative: Initial information received on 03-Jan-2019 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 77 years old male patient who experienced arm has severely bruised around injection site and is red at needle insertion point. Large area of purple, around that was light pink and a white dot at center with what looked like pus in it, while he received vaccine FLUZONE HIGH DOSE. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient did not receive any concomitant medication. On an unknown date, the patient received a 0.5ml dose from pre-filled syringe of suspect Influenza USP Trival A-B High Dose Subvirion Vaccine, lot UJ024AC, expiry date 29-Apr-2029 via intramuscular route in the left deltoid. On an unknown date, the patient developed a non-serious arm has severely bruised around injection site and is red at needle insertion point. Large area of purple, around that was light pink and a white dot at center with what looked like pus in it (vaccination site bruising) with unknown latency following the administration of Influenza USP Trival A-B High Dose Subvirion Vaccine. Lab data was not provided. Final diagnosis was arm has severely bruised around injection site and is red at needle insertion point. Large area of purple, around that was light pink and a white dot at center with what looked like pus in it. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for arm has severely bruised around injection site and is red at needle insertion point. Large area of purple, around that was light pink and a white dot at center with what looked like pus in it. The patient told by pharmacist to seek medical advice from his HCP right away for evaluation and treatment. List of documents held by sender- none.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Cough, Dizziness postural, Vaccination site swelling, Wheezing
Clinical narrative: Vaccine site a little swollen; Coughing - pt states she wheezes when she coughs. Chills/shivering; Light headed with standing up once today; Pt does not want to get the second dose of SHINGRIX.  RN informed pt that these symptoms are common after receiving the vaccine. Supportive care is recommended for symptoms.
Age: 24.0
Sex: M
Vaccine: SMALL
Symptoms: Axillary pain, Chest pain, Hyperhidrosis, Mobility decreased, Oedema peripheral
Clinical narrative: Couldn't Rotate Neck Left to Right; Chest/Armpit Pains (Only on the Left); Mildly Swollen Pits (Only on the Left); Fever: Lots of sweating when woken up.
Age: 24.0
Sex: M
Vaccine: SMALL
Symptoms: Pyrexia
Clinical narrative: Couldn't Rotate Neck Left to Right; Chest/Armpit Pains (Only on the Left); Mildly Swollen Pits (Only on the Left); Fever: Lots of sweating when woken up.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Fatigue, Headache, Myalgia
Clinical narrative: I had muscular aches and pain similar to flu symptoms. I had a fever up to 103 degrees, I was nauseous, fatigue, headache, upset stomach and shivering. These symtoms lasted for approx 4-5 days. I did not contact my health care provider as these symptoms were listed on the receipt I received from the pharmacy. I did take Advil to help reduce the fever and aches.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pyrexia
Clinical narrative: I had muscular aches and pain similar to flu symptoms. I had a fever up to 103 degrees, I was nauseous, fatigue, headache, upset stomach and shivering. These symtoms lasted for approx 4-5 days. I did not contact my health care provider as these symptoms were listed on the receipt I received from the pharmacy. I did take Advil to help reduce the fever and aches.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Adverse Events: Redness, elevated temperature to touch at injection site, extreme swelling and pain in 3 inch diameter around injection site Treatment:  Iced multiple times for 10-15 minute intervals.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature increased, Chills, Headache, Musculoskeletal stiffness, Myalgia
Clinical narrative: Moderate shaking chills/ headache/ neck stiffness/ overall muscle pain/ temp of 100.3/spinal pain/ day 2-slight headache and muscle and neck pain/ Day 3- no remarkable symptoms Treatment-Rest Time -course above.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Neck pain, Spinal pain, Tremor
Clinical narrative: Moderate shaking chills/ headache/ neck stiffness/ overall muscle pain/ temp of 100.3/spinal pain/ day 2-slight headache and muscle and neck pain/ Day 3- no remarkable symptoms Treatment-Rest Time -course above.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Culture urine negative, Dyspnoea, Exposure during pregnancy, Fibrin D dimer normal, Tachycardia
Clinical narrative: 29 y/o G2P1 at 36 weeks GA had symptomatic tachycardia HR 150's and shortness of breath after injection. Went to emergency room morning after. D-dimer negative no PE suspected. UTI was suspected at that time and Keflex prescribed but culture result showed insignificant growth. Pt's sxs self resolved without further treatment.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Urinary tract infection, Urine analysis abnormal
Clinical narrative: 29 y/o G2P1 at 36 weeks GA had symptomatic tachycardia HR 150's and shortness of breath after injection. Went to emergency room morning after. D-dimer negative no PE suspected. UTI was suspected at that time and Keflex prescribed but culture result showed insignificant growth. Pt's sxs self resolved without further treatment.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. There was no information reported regarding the patient's medical history, concurrent conditions, drug reactions, allergies or concomitant medications. On an unspecified date, the patient received a dose of ZOSTAVAX 19400 Plaque-Forming Unit (PFU) subcutaneously (dose number and anatomical location were not reported), lot number N025703 and expiration date 16-DEC-2018, for prophylaxis, after it had expired (expired product administered). No adverse effects were reported in the patient.
Age: 32.0
Sex: F
Vaccine: MMR
Symptoms: Joint stiffness
Clinical narrative: I began having very stiff joints a few weeks after having my baby. It now continues at week 9.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Chapped lips, Facial pain, Lip blister, Lip haemorrhage, Oral herpes
Clinical narrative: I have not had chicken pox in my lifetime or have I had cold sores, not even as a child. Since the vaccine (final one in July 2018) I have had four severe cold sores on my lips. The first adverse effect was about one week after the last vaccine I had a cold sore develop along with tiny blisters on my upper lip; extreme pain in the rightsize of my face (shooting pain). The symptoms are tingling, itching, burning and pain of the affected area. Also, blister like bumps. After the blisters dried, my lip cracked and bled. Two weeks healing time for each one.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Paraesthesia, Pruritus, Rash vesicular
Clinical narrative: I have not had chicken pox in my lifetime or have I had cold sores, not even as a child. Since the vaccine (final one in July 2018) I have had four severe cold sores on my lips. The first adverse effect was about one week after the last vaccine I had a cold sore develop along with tiny blisters on my upper lip; extreme pain in the rightsize of my face (shooting pain). The symptoms are tingling, itching, burning and pain of the affected area. Also, blister like bumps. After the blisters dried, my lip cracked and bled. Two weeks healing time for each one.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Mobility decreased, Musculoskeletal stiffness, Vaccination site pain
Clinical narrative: The evening of the day the vaccine was given, the patient experienced pain in the area the vaccine was administered. Since that time, the patient has experienced pain in her upper left arm and stiffness in her neck. She stated she is unable to lift her left arm all the way up and has difficulty moving her head down towards her chest. Patient followed up with her primary care provider on 1/7/19. Her provider referred her to physical therapy. Patient stated that she will begin physical therapy on 1/11/19.
Age: 70.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema
Clinical narrative: Called 1/5/19, experiencing redness from the injection site area to elbow and inside arm. On 1/6/19, patient visited urgent care and diagnosed with Cellulitis.
Age: 65.0
Sex: F
Vaccine: UNK
Symptoms: Injection site erythema, Injection site pain, Injection site vesicles
Clinical narrative: Red blisters slowly appeared around the injection site on arm below shoulder. Became painful. Slowly healing but taking some time. May leave discolored skin after it heals.
Age: 17.0
Sex: F
Vaccine: MNQ, VARCEL
Symptoms: Dizziness, Extra dose administered, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Patient complains of extreme itchiness and pain at the injection site of where I gave the Varicella vaccine. According to the patient these symptoms began the afternoon following the injection. She told me that during the two days following the injection, she experienced light-headedness and a fever. Her father told her to put NEOSPORIN on the area and gave her TYLENOL. She appeared in my clinic at 10:40 AM on 1/10/19. I observed the area and it is red, firm and warm in a 2.5 inch circle around the injection site. The patient is afebrile and not experiencing any light-headedness. I explained that NEOSPORIN is for wound care, not a reaction of this type. I informed her she could see a local pharmacist for an antihistamine medication such as BENADRYL or ask about a cortisone cream. I also informed her if the area worsens or if she is not feeling better in a couple more days to see a physician. It was brought to my attention after she received the second dose of varicella vaccine that she was in our immunization registry and had received two other doses of varicella vaccine making the dose I gave her the fourth dose she had received. The first two doses were not indicated on her shot record that she displayed upon her first visit with us.
Age: 17.0
Sex: F
Vaccine: MNQ, VARCEL
Symptoms: Injection site pruritus, Injection site warmth, Pyrexia
Clinical narrative: Patient complains of extreme itchiness and pain at the injection site of where I gave the Varicella vaccine. According to the patient these symptoms began the afternoon following the injection. She told me that during the two days following the injection, she experienced light-headedness and a fever. Her father told her to put NEOSPORIN on the area and gave her TYLENOL. She appeared in my clinic at 10:40 AM on 1/10/19. I observed the area and it is red, firm and warm in a 2.5 inch circle around the injection site. The patient is afebrile and not experiencing any light-headedness. I explained that NEOSPORIN is for wound care, not a reaction of this type. I informed her she could see a local pharmacist for an antihistamine medication such as BENADRYL or ask about a cortisone cream. I also informed her if the area worsens or if she is not feeling better in a couple more days to see a physician. It was brought to my attention after she received the second dose of varicella vaccine that she was in our immunization registry and had received two other doses of varicella vaccine making the dose I gave her the fourth dose she had received. The first two doses were not indicated on her shot record that she displayed upon her first visit with us.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Insomnia, Pain, Pain in extremity
Clinical narrative: Sore arm. Fatigue. Headache. Sleeplessness. Achy.
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 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 23-DEC-2014, a physician administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). In January 2015, the patient was treated by a healthcare provider for shingles. 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: Syringe issue
Clinical narrative: This spontaneous report was received from a nurse, concerning a child patient of unknown age and gender. There was no information about the patient's medical history, concurrent conditions, drug reactions/allergies or concomitant medications. On an unknown date, the nurse attempted to administer a dose of VAQTA 25U/0.5ml PED (pediatric) lot # R010368 with expiration date of 25-MAR-2019, for prophylaxis, but the plunger fell out of the syringe barrel (product quality issue) after touching the patient but before administering the dose. A second syringe was obtained and a dose of VAQTA was administered intramuscularly, during the same office visit for prophylaxis (dose, anatomical location, lot number and expiration date were not reported). The outcome of product quality issue and the causal relationship between product quality issue and therapy with VAQTA was not provided.
Sex: F
Vaccine: VARZOS
Symptoms: Deafness neurosensory, Dizziness, Fall, Tinnitus, Vertigo
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 medications. In or around 18-AUG-2016, the patient was vaccinated with the ZOSTAVAX (lot number, dosage and route of administration not provided) for its intended purpose the prevention of shingles, Shortly thereafter, the patient reported falling out of bed due to dizziness and ringing in her ears. In or around February 2017, the patient presented to her physician for these issues and was diagnosed with vertigo, bilateral tinnitus, and sensorineural hearing loss. As a direct and proximate result of ZOSTAVAX, the patient's symptoms have resulted in physical limitations not present prior to ZOSTAVAX. The patient has also experienced mental and emotional distress due to resulting physical limitations and the seriousness of her condition. As a result of the ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was considered to be not recovered. Upon internal review, sensorineural hearing loss was determined to be medically significant. Falling out of bed due to dizziness, vertigo, bilateral tinnitus, and sensorineural hearing loss were considered disabling. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Fatigue, Impaired work ability, Pyrexia
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of fever in a female patient who received SHINGRIX for prophylaxis. In July 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever, feelings of weakness and fatigue. On an unknown date, the outcome of the fever, feelings of weakness and fatigue were unknown. It was unknown if the reporter considered the fever, feelings of weakness and fatigue to be related to SHINGRIX. Additional details were provided as follows: The patient was over 50 years. The age at vaccination was not reported. The patient experienced a feeling of weakness, fatigue and feverish. This event ran into the next day and the patient missed work as a result. The reporter agreed to follow up if necessary.
Age: 49.0
Sex: M
Vaccine: FLU4
Symptoms: H1N1 influenza, Influenza A virus test positive, Vaccination failure
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of suspected vaccination failure in a patient who received FLUARIX QUADRIVALENT 2018-2019 season for prophylaxis. On an unknown date, the patient received FLUARIX QUADRIVALENT 2018-2019 season at an unknown dose. On an unknown date, less than a year after receiving FLUARIX QUADRIVALENT 2018-2019 season, the patient experienced vaccination failure (serious criteria GSK medically significant) and h1n1 influenza. On an unknown date, the outcome of the vaccination failure and h1n1 influenza were unknown. It was unknown if the reporter considered the vaccination failure and h1n1 influenza to be related to FLUARIX QUADRIVALENT 2018-2019 season. Additional information received as follows: The age at vaccination was not reported. The healthcare professional reported that they had the patient who received the FLUARIX QUADRIVALENT 2018-2019 season that was just confirmed with the flu. On an unknown date, the patient underwent lab test resulted strain Novel 2009 H1N1 positive. This case was considered as a suspected vaccination failure case as the time to onset for influenza were unknown. The reporter was unsure if this was a vaccination failure or not. Lab Comments: On an unknown date, the patient underwent lab test resulted strain Novel 2009 H1N1 positive.