chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Joint range of motion decreased, Muscle strain
Clinical narrative: The injection was painful and the injection site remained painful for a few days. It was more painful than in past years, but I brushed it off as normal reaction anyway, especially as the contact pain, redness, and swelling went away. However, since then, I have been left with shoulder pain. It is a burning pain and deep strain in what feels like the muscle where the shot was administered. It is constant, somewhat limits my range of motion (backward), bothers me when lifting heavy objects, and also wakes me up at night to the point that I have to sit up and try to rub and stretch my arm in different ways.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal pain, Pain
Clinical narrative: The injection was painful and the injection site remained painful for a few days. It was more painful than in past years, but I brushed it off as normal reaction anyway, especially as the contact pain, redness, and swelling went away. However, since then, I have been left with shoulder pain. It is a burning pain and deep strain in what feels like the muscle where the shot was administered. It is constant, somewhat limits my range of motion (backward), bothers me when lifting heavy objects, and also wakes me up at night to the point that I have to sit up and try to rub and stretch my arm in different ways.
Age: 61.0
Sex: M
Vaccine: FLU4
Symptoms: Chills, Fatigue, Pain, Pyrexia
Clinical narrative: Fever, chills, body aches, fatigue.
Age: 1.08
Sex: F
Vaccine: FLU4, MMRV, VARCEL
Symptoms: Decreased appetite, Irritability, Pyrexia, Urine analysis
Clinical narrative: Febrile, decreased appetite, irritability.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Headache, Mobility decreased, Nausea
Clinical narrative: Sudden onset of Fever of 101, Chills, neck pain headache, nausea, and dizziness, the evening of 9/27. Unable to get out of bed. Patient contacted PCP following day and was prescribed ZOFRAN for the nausea and Ibuprofen for fever/pain. Symptoms improved the following day and resolved by 9/29/2018. No emergent care was required/reported by patient.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Neck pain, Pyrexia
Clinical narrative: Sudden onset of Fever of 101, Chills, neck pain headache, nausea, and dizziness, the evening of 9/27. Unable to get out of bed. Patient contacted PCP following day and was prescribed ZOFRAN for the nausea and Ibuprofen for fever/pain. Symptoms improved the following day and resolved by 9/29/2018. No emergent care was required/reported by patient.
Age: 87.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site bruising, Injection site discolouration, Injection site swelling
Clinical narrative: Pt developed a red-bluish bruise around the injection site area. Also has some yellowing and swelling.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Febrile convulsion
Clinical narrative: Pt experienced febrile seizure.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Back pain, Fall, Headache, Hypoaesthesia
Clinical narrative: 77yr old patient with history of T2DM, HTN, chronic pain, afib presented to PCP on 9/20. During this visit, patient endorsed 7/10 knee pain. Patient reported seeing orthopedic surgeon recently and receiving joint injection and aspiration of Baker's cyst. MD prescribed meloxicam 7.5mg PO daily for pain. Patient received Flu Vaccine, High dose trivalent IM in right deltoid on 9/20. On 9/25, patient called office complaining of pain in back, hips and legs. MD changed pain medication to naproxen EC 500mg BID. On 9/28, patient called stating "unable to walk without walker, can not turn self in bed and arms very weak". Patient also endorsed numbness and tingling in arms and legs. Patient instructed to go to ED. Patient instructed to go to ED for rule out GBS. Patient went to Medical Center but left AMA without seeing provider on 9/28. Patient called office on 10/1 stating gotten worse over weekend and endorsed "cannot feel or move legs, worse back pain, and very bad headache". Patient advised to return to ED for evaluation. Patient returned to MC and noted with 3/5 bilateral LE, with "multiple falls over the past week". Patient in process to be transferred but then again left AMA. Patient presented to MC again on 10/2 with slight improvement, able to ambulate with staff, 4/5 bilateral LE. Patient admitted to MC for further monitoring.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Muscular weakness, Pain in extremity, Paraesthesia, Walking aid user
Clinical narrative: 77yr old patient with history of T2DM, HTN, chronic pain, afib presented to PCP on 9/20. During this visit, patient endorsed 7/10 knee pain. Patient reported seeing orthopedic surgeon recently and receiving joint injection and aspiration of Baker's cyst. MD prescribed meloxicam 7.5mg PO daily for pain. Patient received Flu Vaccine, High dose trivalent IM in right deltoid on 9/20. On 9/25, patient called office complaining of pain in back, hips and legs. MD changed pain medication to naproxen EC 500mg BID. On 9/28, patient called stating "unable to walk without walker, can not turn self in bed and arms very weak". Patient also endorsed numbness and tingling in arms and legs. Patient instructed to go to ED. Patient instructed to go to ED for rule out GBS. Patient went to Medical Center but left AMA without seeing provider on 9/28. Patient called office on 10/1 stating gotten worse over weekend and endorsed "cannot feel or move legs, worse back pain, and very bad headache". Patient advised to return to ED for evaluation. Patient returned to MC and noted with 3/5 bilateral LE, with "multiple falls over the past week". Patient in process to be transferred but then again left AMA. Patient presented to MC again on 10/2 with slight improvement, able to ambulate with staff, 4/5 bilateral LE. Patient admitted to MC for further monitoring.
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Lymphadenopathy
Clinical narrative: Swollen gland in neck.
Age: 59.0
Sex: F
Vaccine: FLUR4
Symptoms: Injection site bruising, Injection site discolouration
Clinical narrative: Pt developed a red-blue bruise around injection site.
Age: 24.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Hyperhidrosis, Hypoaesthesia oral, Skin warm, Vitreous floaters
Clinical narrative: Patient experienced possible flushing, she turned really red and really hot and sweaty about 3-5 minutes after the injection. She stated seeing flutters, and slight numbness in her lips. She was monitored and talked to by a healthcare provider, while staying seated. She was offered water and chips, and felt better after consumption of both. She stayed within the pharmacy for 30 minutes, and felt fine upon leaving.
Age: 26.0
Sex: M
Vaccine: FLUC4
Symptoms: Blood test, Borrelia test, Electromyogram, Hypoaesthesia, Immediate post-injection reaction
Clinical narrative: Immediately after the injection I was having right pectorals and sub scapular pain. Two days after, I began developing numbness in right arm. Three days after I began to experience numbness and tingling in bilateral feet as well. Four days later I began to experience left hand and arm numbness and tingling as well. Six days after I am now developing bilateral axilla tingling as well as tingling up into the medial thighs and occasionally into the right mandibular region.
Age: 26.0
Sex: M
Vaccine: FLUC4
Symptoms: Myalgia, Nerve conduction studies, Nuclear magnetic resonance imaging, Paraesthesia
Clinical narrative: Immediately after the injection I was having right pectorals and sub scapular pain. Two days after, I began developing numbness in right arm. Three days after I began to experience numbness and tingling in bilateral feet as well. Four days later I began to experience left hand and arm numbness and tingling as well. Six days after I am now developing bilateral axilla tingling as well as tingling up into the medial thighs and occasionally into the right mandibular region.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Hyperaesthesia, Mobility decreased, Pain in extremity, Peripheral swelling
Clinical narrative: Arm became swollen and red. It traveled around the muscle of the arm like a band. Pain, unable to bend arm, hot like a sunburn, skin very sensitive. Went to urgent care and was prescribed KEFLEX 500 mgs. 1 every 6 hours.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Skin warm
Clinical narrative: Arm became swollen and red. It traveled around the muscle of the arm like a band. Pain, unable to bend arm, hot like a sunburn, skin very sensitive. Went to urgent care and was prescribed KEFLEX 500 mgs. 1 every 6 hours.
Age: 6.0
Sex: M
Vaccine: FLU4
Symptoms: Contraindication to vaccination
Clinical narrative: Initial information received on 26-Sep-2018 regarding an unsolicited valid non-serious case received from a consumer. This case involves a six years old male patient who was vaccinated with a dose of FLUZONE QUADRIVALENT (Batch number: UI422AB, expiration date: 30-Jun-2016, dose, route and site of administration was not reported) on 26-Sep-2018. The patient's past medical history included Food allergy (egg). The patient's past vaccination(s) included Flu shot and had had an absent Seizure for 3-4 hours (he stared into space). The patient's past medical treatment(s) and family history were not provided. It was an actual medication error due to contraindication to vaccination and product use in unapproved population (received a FLUZONE QUADRIVALENT and he is allergic to eggs). 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.
Age: 75.0
Sex: F
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: Initial information received on 26-Sep-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 75 years old female patient who was vaccinated with a 0.5 ml dose of FLUZONE QUADRIVALENT (Batch number: UI986AA, expiration date: 30-Jun-2019, site of administration: right deltoid and route was not reported) on 18-Sep-2018. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to incorrect product storage (vaccine was exposed to 31.5F for 1 hour and 40 minutes). 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.
Age: 55.0
Sex: M
Vaccine: FLU3
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 26-Sep-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 55 years old male patient who was vaccinated with 0.5 ml dose of FLUZONE HIGH DOSE (batch number lot UJ023AA and expiration date 25-APR-2019 via intramuscular route in the left deltoid on 25-Sep-2018. The patients medical history and concomitant medications were not reported. It was an actual medication error due to vaccine administered to patient of inappropriate age and overdose. It was reported that, patient visited to physician at 25-Sep-2018. No information about any adverse event reported. 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 and Module VI of the 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: U
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, Overdose, Wrong drug administered
Clinical narrative: Initial information received on 26-Sep-2018 regarding an unsolicited valid non-serious case received from a consumer. This case is linked 2018SA271076, 2018SA271075, 2018SA271074, 2018SA271077. This case involve adult patient who received FLUZONE HIGH DOSE (Batch number, expiry date, route and site of administration were not reported) instead of FLUZONE QUADRIVALENT on an unspecified date. It was a case of actual medication error as Wrong vaccine administered, inappropriate age at vaccine administration and overdose as an employee below 65 years age who received the FLUZONE HIGH-DOSE instead of the FLUZONE QUADRIVALENT. Nurse stated that the nurse who was giving the injections picked out the wrong medication and administered to 5 employees who were not 65 plus age. It was unknown if any adverse event was reported. 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: U
Vaccine: FLU3
Symptoms: Expired product administered
Clinical narrative: Initial information received on 26-Sep-2018 regarding an unsolicited valid non-serious case received from an other health professional. This case involves elderly patient (age and gender not reported), who was vaccinated with an expired dose of FLUZONE HIGH DOSE (expiry date: 29-May-2018) (Batch number, expiry date, dose, dose in series, route and site of administration were not reported) on 25-Sep-2018. The patient's past medical history, medical treatment(s), vaccination(s), family history and concomitant medications were not provided. It was a case of actual medication error due to expired vaccine used. It was unknown if any adverse event was occurred or not following the vaccination. 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: U
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, Wrong drug administered
Clinical narrative: Initial information received on 26-Sep-2018 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case is linked with 2018SA271076, 2018SA271075, 2018SA271077, 2018SA271072. This case involves an adult patient (age, gender not specified) who received the fluzone high-dose instead of the fluzone quadrivalent who are not 65 plus years of age, while he/she received vaccine FLUZONE HIGH DOSE and FLUZONE QUADRIVALENT. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE instead of QUADRIVALENT INFLUENZA VACCINE lot number not reported via unknown route. It was a case of actual medication error due to wrong vaccine administered, inappropriate age at vaccine administration and overdose. It was reported as 5 employees who received the fluzone high-dose instead of the fluzone quadrivalent who are not 65 plus years of age. The patient outcome is reported as Not Applicable for received the fluzone high-dose instead of the fluzone quadrivalent. 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 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.
Sex: U
Vaccine: TDAP
Symptoms: Injection site pain, Pain
Clinical narrative: Initial information received on 26-Sep-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked with case 2018SA271096 (same patient for Flu vaccine). This case involves a patient (age and gender not reported), who experienced "being really sore" all over her body, and injection site soreness while received vaccine ADACEL. The patient's past vaccination(s) included influenza vaccine and it was reported that patient had an "immune response" after receiving the flu vaccine last year. She does not know what brand of flu vaccine she received. She reports within 2 weeks "being really sore" all over her body. Reports her HCP advised her to take BENADRYL and APAP before the shot. On an unknown date, the patient received a dose of suspect ADACEL lot number not reported. On an unknown date, the patient developed a non-serious "being really sore" all over her body (pain) and injection site soreness following the administration of ADACEL. No Lab data was reported. Final diagnosis was "being really sore" all over her body and injection site soreness. The patient was treated with BENADRYL for Product used for unknown indication and APAP for Product used for unknown indication. The patient outcome is reported as Unknown for the events. Documents held by the sender: none.
Age: 19.0
Sex: M
Vaccine: HEPA, IPV, TD
Symptoms: Incorrect dose administered, Injection site pain
Clinical narrative: Initial information received on 26-Sep-2018 regarding an unsolicited valid non-serious case received from a physician. This case involves a 19 years old male patient who experienced soreness at injection site/ left arm is sore at injection site while he received vaccine IPOL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included TENIVAC for Immunisation; and HEPATITIS A VACCINE for Immunisation in the right arm on an unknown date. On 26-Sep-2018, the patient received a 2.5 ml dose of suspect IPV (VERO) (lot number: B1G51 and expiry date: 02-Aug-2019) in the left deltoid (route of administration were not reported). On an unknown date, the patient developed a non-serious soreness at injection site/ left arm is sore at injection site following the administration of IPV (VERO). It was also a case of actual medication error due to overdose because 2.5 ml total to a patient and the patient was given an excessive dose. No Lab data was reported. Final diagnosis was gave an excessive dose/ just gave 5 times the normal dose of ipol, gave 2.5 ml total to a patient and does have soreness at injection site/ left arm is sore at injection site. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for does have soreness at injection site/ left arm is sore at injection site. 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: F
Vaccine: FLUX
Symptoms: Pain
Clinical narrative: Initial information received on 26-Sep-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to case 2018SA271099 and 2018SA271079 (same reporter, same patient). This case involves a adult female patient who experienced being really sore all over her body, while she received vaccine Flu vaccine [Influenza vaccine]. The patient's past medical history, medical treatment(s) and family history were not provided. On an unknown date, the patient received a dose of suspect Influenza vaccine [Flu vaccine] MFR unknown (batch number, dose, expiry date, route and site of administration were not reported). On an unknown date, within 2 weeks patient developed a non-serious sore all over her body (pain) following the administration of Influenza vaccine [Flu vaccine] . Relevant tests were not reported. Final diagnosis was being really sore all over her body. It was not reported if the patient received a corrective treatment (her HCP advised her to take Benadryl and APAP before the shot). The outcome of the event reported as unknown. List of documents held by sender: none.
Sex: F
Vaccine: FLUX
Symptoms: Vaccination failure
Clinical narrative: Initial information received on 26-Sep-2018 regarding an unsolicited valid non-serious case received from a consumer. This case is linked to case 2018SA271224 for reporter's husband. This case involves an unknown age female patient who had a higher dose flu vaccine last year. it didnt work. The patient's past medical history, concomitant medication and family history were not provided. On an unknown date, the patient received injection of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number, expiry date not reported via unknown route in unknown administration site. On an unknown date, the patient reported to had a higher dose flu vaccine last year. it didnt work. (drug ineffective) with Unknown latency following the administration of INFLUENZA VACCINE. Lab data was not provided. Final diagnosis was had a higher dose flu vaccine last year. it didnt work. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Not Applicable for had a higher dose flu vaccine last year. it didnt work. List of documents held by sender- none.
Sex: U
Vaccine: FLUX
Symptoms: Injection site rash, Pruritus
Clinical narrative: Initial information received on 28-Sep-2018 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case involves 15 patients who experienced complained of having itchy and rashes at injection site, while she received vaccine INFLUENZA VACCINE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route. The patient developed a non-serious complained of having itchy (pruritus) following the administration of INFLUENZA VACCINE. The patient developed a non-serious rashes at injection site (injection site rash) following the administration of INFLUENZA VACCINE. (Other relevant tests included No lab test.) Final diagnosis was rashes at injection site and complained of having itchy. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for complained of having itchy and as Unknown for rashes at injection site.
Age: 29.0
Sex: F
Vaccine: FLU4
Symptoms: Feeling hot, Hypoaesthesia, Paraesthesia
Clinical narrative: Warm sensation in my right arm and right ear, fingertips were tingling and numb feeling. Spoke with Dr and everything was fine.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Dizziness, Muscle spasms, Muscle twitching, Nausea, Pallor
Clinical narrative: Following administration of Tdap, MENACTRA, HPV and a PPD placement, pt felt dizzy, nauseous, pallor and involuntary muscle twitching of legs, abdomen and arms. She lied down for about an hour, drank some Gatorade and ate some crackers. She attempted to meditate which seemed to help symptoms. Muscle spasms began to abate after about an hour and she was able to self-ambulate out of the office.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Asthenia, Chills, Headache, Hyperhidrosis
Clinical narrative: Shivering, severe headache, shooting joint pain in hips, fingers, knees, toes, jaw. Severe weakness, nausea, burning skin and nerves (like I had a bad sunburn), sweats. Started about 8 hrs after shot, continued for 12+ hours. Headache, weakness and sweats lingering.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Neuralgia, Pain, Pain in extremity, Pain in jaw
Clinical narrative: Shivering, severe headache, shooting joint pain in hips, fingers, knees, toes, jaw. Severe weakness, nausea, burning skin and nerves (like I had a bad sunburn), sweats. Started about 8 hrs after shot, continued for 12+ hours. Headache, weakness and sweats lingering.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin burning sensation
Clinical narrative: Shivering, severe headache, shooting joint pain in hips, fingers, knees, toes, jaw. Severe weakness, nausea, burning skin and nerves (like I had a bad sunburn), sweats. Started about 8 hrs after shot, continued for 12+ hours. Headache, weakness and sweats lingering.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Erythema, Headache, Muscular weakness
Clinical narrative: Soreness and redness on the arm started 2 hours after the injection. Then chills, fever, headache, muscle weakness, upset stomach and nausea continued for 48 hours after injection.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pain in extremity, Pyrexia
Clinical narrative: Soreness and redness on the arm started 2 hours after the injection. Then chills, fever, headache, muscle weakness, upset stomach and nausea continued for 48 hours after injection.
Age: 60.0
Sex: F
Vaccine: HEPA
Symptoms: Dyspnoea, Pruritus
Clinical narrative: Approximately 15 mins post vaccine the patient began to have dyspnea and itching.
Age: 51.0
Sex: F
Vaccine: FLU4, HEPAB
Symptoms: Breath sounds abnormal, Cold sweat, Loss of consciousness, Nausea, Peripheral coldness
Clinical narrative: Patient had been administered FLUZONE QUAD first and TWINRIX second. After the TWINRIX patient said she was about to throw up and after few seconds patient lost consciousness. Hands were cold and the head had cold sweats, after that the patient started to produce a growling sound, pharmacist administered EPI PEN right away, after the administration, pharmacist requested cashier/ technician to call  911. Patient regained consciousness before the EMS arrived. EMS checked the patients vitals and it was normal. Patient left premises with the EMS.
Age: 72.0
Sex: F
Vaccine: FLUA3
Symptoms: Blood pressure increased, Flank pain
Clinical narrative: Patient stated her blood pressure increased and she had to go to the hospital the following day. Now her blood pressure is lowered by a lot and she has pain in her side.
Age: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Skin warm
Clinical narrative: Red, warm to touch, circular area 10cm by 10cm. Prescribed Benadryl 25 mg 1 pill Q6 prn.
Age: 47.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: 6.2 cm  x 4.5 cm erythematous, indurated, warm to touch area at injection site.
Age: 5.0
Sex: M
Vaccine: DTAP, HIBV, MMR, VARCEL
Symptoms: Local reaction, Nausea, Urticaria, Vomiting
Clinical narrative: This literature marketed information has been received from a published literature article title as stated above and refers to a 5-year-old boy with a history of known beef, pork, and milk allergy whoon an unspecified date, was vaccinated with M-M-R II and VARIVAX, (strength, dose, route of administration, lot number and expiration date were not provided for both vaccines). Concomitant vaccines, included Hib conj vaccine (unspecified carrier) and diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid. In approximately 2010, after receiving the vaccines, he developeda large local reaction, disseminated urticaria, shortness of breath, nausea and vomiting. Emergency department treatment with medications and diagnosis were not reported. The sIgE was not reported. The outcome of the event was not reported. The author considered the events as reactions associated to M-M-R II and VARIVAX. This is one of several reports from the same reporter (Case #  US-009507513-1809USA012067, US-009507513-1809USA012063,US-009507513-1809USA012064, US-009507513-1809USA012066, US-009507513-1809USA012062).; Sender's Comments: US-009507513-1809USA012060: US-009507513-1809USA012067: US-009507513-1809USA012063: US-009507513-1809USA012064: US-009507513-1809USA012065: US-009507513-1809USA012066: US-009507513-1809USA012061: US-009507513-1809USA012062:
Sex: M
Vaccine: VARCEL
Symptoms: Hypersensitivity, Injection site reaction, Local reaction
Clinical narrative: This literature marketed information has been received from a published literature article title as stated above and refers to a 13-year-old boy with known beef, pork, and milk allergy who in approximately 2009, experienced a large local reaction from the injection site on the thigh to the toes after VARIVAX (vaccination date, dose, route, vaccination site, lot# and expiration date were not provided), for prophylaxis. The patient was diagnosed as an allergic reaction by treating physician. At the time of reporting, the outcome of the allergic reaction was unknown. The reporter considered the allergic reaction related to VARIVAX. This is one of several reports from the same reporter (Case # US-009507513-1809USA011156, US-009507513-1809USA012067, US-009507513-1809USA012063,US-009507513-1809USA012064, US-009507513-1809USA012066, US-009507513-1809USA012062).; Sender's Comments: US-009507513-1809USA011156:
Age: 55.0
Sex: F
Vaccine: MMR
Symptoms: Oedema peripheral, Urticaria
Clinical narrative: This literature marketed information has been received from a published literature article title as stated above and refers to a 55 years old women, with known preexisting alpha-gal allergy. The patient developed on an unspecified date in 2017, disseminated urticaria and peripheral edema within 30 min of M-M-R II (dose, route, vaccination site, lot# and expiration date were not provided), for prophylaxis. The patient was treated at home with BENADRYL. At the time of reporting, the outcome of the events was not reported. The reporter considered the events to be related to M-M-R II. A copy of the published article is attached as further documentation of the patient's experience. This is one of several reports from the same reporter Case # US-009507513-1809USA011156, US-009507513-1809USA012060, US-009507513-1809USA012067, US-009507513-1809USA012063,US-009507513-1809USA012064, US-009507513-1809USA012066).; Sender's Comments: US-009507513-1809USA011156:Original Case: 1809USA011156.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Pain, Pruritus, Rash erythematous, Swelling face, Vomiting
Clinical narrative: This literature marketed information has been received from a published literature article and refers to a 4-year-old boy with known pork allergy, with suspected gelatin allergy. The patient developed on an unspecified date in approximately 2014, disseminated erythematous rash with itching, aching, facial swelling and emesis after vaccination with M-M-R II (dose, route, vaccination site, lot# and expiration date were not provided) and VARIVAX (dose, route, vaccination site, lot# and expiration date were not provided), for prophylaxis. Concomitant vaccinations included DTaP/IPV. At the time of reporting, the outcome of the events was not reported. The author considered the events as reactions associated to M-M-R II and VARIVAX. This is one of several reports from the same reporter Case # US-009507513-1809USA011156, US-009507513-1809USA012060, US-009507513-1809USA012067, US-009507513-1809USA012063, US-009507513-1809USA012066, US-009507513-1809USA012062). Sender's Comments: US-009507513-1809USA011156.
Sex: M
Vaccine: HEPA
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: This spontaneous report as received from a physician via company representative and refers to a 2-year-old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 24-SEP-2018, the patient was vaccinated with an "adult dose" of VAQTA 50/1.0 U/ml, lot # N028743, expiration date: 23-NOV-2018 (anatomical location, dose and route of administration were not reported) for prophylaxis. The physician reported that the patient was fine, he was not hospitalized. No adverse effects were reported.
Sex: U
Vaccine: HEP
Symptoms: Serology test, Therapeutic response decreased
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of therapeutic response decreased in a child patient who received Hepatitis B vaccine for prophylaxis.  On an unknown date, the patient received Hepatitis B vaccine. On an unknown date, unknown after receiving Hepatitis B vaccine, 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 Hepatitis B vaccine. Additional details were provided as follows: The age at vaccination was not reported. The patient received a full series of hepatitis B vaccine with an unknown brand name as a child. Titers were drawn and they were low (therapeutic response decreased). The patient received one booster dose with ENGERIX-B on 17th August 2018. The reporter declined to provide more information. Lab Comments: On an unknown date, the lab test was performed.
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Haemorrhage, Headache, Pain, Vaccine positive rechallenge
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of hemorrhage in a male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of haemorrhage (1st dose received on an unknown date, refer case US2018GSK179164). On an unknown date, the patient received the 2nd dose of SHINGRIX (intramuscular). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced hemorrhage (serious criteria GSK medically significant), general body pain, headache and chills. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the hemorrhage, general body pain, headache and chills were recovered/resolved. It was unknown if the reporter considered the hemorrhage, general body pain, headache and chills to be related to SHINGRIX. Additional information received as follows: The case was reported by the patient's wife. The age at vaccination was not reported. The patient received SHINGRIX on the left arm. The reporter said that the patient had headache, body aches and chills after dose of SHINGRIX. He did not have any symptoms after the 1st dose. The symptoms lasted about 1 day. The patient noted that he bled more after the 2nd dose compared to the 1st dose of SHINGRIX.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site cellulitis
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site cellulitis in a female patient who received SHINGRIX for prophylaxis. On 18th September 2018, the patient received SHINGRIX. In September 2018, less than a month after receiving SHINGRIX, the patient experienced injection site cellulitis. On an unknown date, the outcome of the injection site cellulitis was unknown. It was unknown if the reporter considered the injection site cellulitis to be related to SHINGRIX. Additional details were provided as follows: This case was reported via chat. The age at vaccination was not reported. The healthcare professional (HCP) stated that the pharmacist reached out because the patient believed she had a reaction to SHINGRIX. The patient's physician looked at the injection site and believed it was cellulitis. The pharmacist was reaching out because the physician wanted to give her an antibiotic and she wanted to make sure that was appropriate. The HCP did not have any further information.
Sex: U
Vaccine: VARZOS
Symptoms: Bone pain, Chills, Influenza like illness, Pain, Pyrexia
Clinical narrative: This case was reported by a consumer and described the occurrence of chills in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, several hours after receiving SHINGRIX, the patient experienced chills, fever, general body pain, influenza-like symptoms and bone pain. On an unknown date, the outcome of the chills, fever, general body pain, influenza-like symptoms and bone pain were recovered/resolved. It was unknown if the reporter considered the chills, fever, general body pain, influenza-like symptoms and bone pain to be related to SHINGRIX. Additional details were provided as follows: The patient was just sharing information, and she did not want anything. The age at vaccination was not reported, the patient received the first dose of SHINGRIX and a few hours after the patient  experienced chills, fever and it ached all over, the patient felt like had the flu, the  bones ached and was okay after 12 hours. This case has been linked with case US2018GSK179197 reported by the same reporter for the same patient.
Sex: U
Vaccine: VARZOS
Symptoms: Pityriasis rosea
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pityriasis rosea in a patient who received SHINGRIX for prophylaxis. On 1st August 2018, the patient received the 2nd dose of SHINGRIX. On an unknown date, 7 days after receiving SHINGRIX, the patient experienced pityriasis rosea. On an unknown date, the outcome of the pityriasis rosea was unknown. It was unknown if the reporter considered the pityriasis rosea to be related to SHINGRIX. Additional details were provided as follows: This case was reported via a live click to chat. The age at vaccination was not reported. The patient received the vaccine in left arm. One week after receiving SHINGRIX, the patient had some kind of pituriasis rosea like eruption on back. The diagnosis was made by a dermatologist and primary care physician.
Sex: M
Vaccine: VARZOS
Symptoms: Haemorrhage
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of hemorrhage in a male 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 hemorrhage (serious criteria GSK medically significant). On an unknown date, the outcome of the hemorrhage was recovered/resolved. It was unknown if the reporter considered the hemorrhage to be related to SHINGRIX. Additional information received as follows: The case was reported by the patient's wife. The age at vaccination was not reported but it could be 55 or 56 years. The reporter said that the patient did not have any symptoms after the 1st dose, just noted that he bled more after the 2nd dose compared to the 1st dose of SHINGRIX. For tolerance to next dose, refer case US2018175501.
Sex: U
Vaccine: VARZOS
Symptoms: Bone pain, Chills, Influenza like illness, Pain, Pyrexia
Clinical narrative: This case was reported by a consumer and described the occurrence of chills in a adult patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of chills (1st dose received refer case US2018GSK173995). On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced chills, fever, general body pain, influenza-like symptoms and bone pain. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the chills, general body pain, influenza-like symptoms and bone pain were unknown and the outcome of the fever was not recovered/not resolved. It was unknown if the reporter considered the chills, fever, general body pain, influenza-like symptoms and bone pain to be related to SHINGRIX. Additional details were provided as follows: The patient was just sharing information, and she did not want anything. The age at vaccination was not reported, the patient received the first dose of SHINGRIX and a few hours after the patient experienced chills, fever and it ached all over, the patient felt like had the flu, the bones ached and was okay after 12 hours. This case has been linked with case US2018GSK179197 reported by the same reporter for the same patient.
Sex: U
Vaccine: VARZOS
Symptoms: Vaccine positive rechallenge
Clinical narrative: This case was reported by a consumer and described the occurrence of chills in a adult patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of chills (1st dose received refer case US2018GSK173995). On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced chills, fever, general body pain, influenza-like symptoms and bone pain. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the chills, general body pain, influenza-like symptoms and bone pain were unknown and the outcome of the fever was not recovered/not resolved. It was unknown if the reporter considered the chills, fever, general body pain, influenza-like symptoms and bone pain to be related to SHINGRIX. Additional details were provided as follows: The patient was just sharing information, and she did not want anything. The age at vaccination was not reported, the patient received the first dose of SHINGRIX and a few hours after the patient experienced chills, fever and it ached all over, the patient felt like had the flu, the bones ached and was okay after 12 hours. This case has been linked with case US2018GSK179197 reported by the same reporter for the same patient.
Sex: U
Vaccine: PNC13
Symptoms: Product storage error
Clinical narrative: This is a spontaneous report from a contactable healthcare professional. A patient of unspecified age and gender received PREVNAR 13; (lot number and expiration date unknown), via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The reporter wanted stability information during temperature excursions. On an unspecified date, temperature at 72F for 186h was reported and they gave 1 dose to 1 patient. Information on the lot number/batch number was requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Fever chills and body aches.
Age: 35.0
Sex: F
Vaccine: FLUC4
Symptoms: Burning sensation, Chills, Cough, Dizziness, Dyspnoea
Clinical narrative: Within 10-20 min after the shot was administered at 9:40 am, my face started burning and I started feeling dizzy. From approx 10:30 am - 1:30 pm, symptoms progressively got worse. Around my eyes felt puffy and burning, my lower lip felt puffy, my throat started itching, then I started coughing, then my throat started to feel like it was closing up and I was having trouble breathing by around 1 pm. I started to have hives and my skin was red to the appearance on my chest and arms. I made it to urgent care around 2 pm and they administered a shot of BENADRYL and a shot of a steroid to bring down the inflammation. Within 10 minutes of these being administered, I could breath normally again and my allergy symptoms started to disappear. Then I slept for about 14 hours. The next day I felt like I had flu-like symptoms, hot/cold chills, fever, achy body.
Age: 35.0
Sex: F
Vaccine: FLUC4
Symptoms: Erythema, Eye irritation, Eye swelling, Feeling of body temperature change, Influenza like illness
Clinical narrative: Within 10-20 min after the shot was administered at 9:40 am, my face started burning and I started feeling dizzy. From approx 10:30 am - 1:30 pm, symptoms progressively got worse. Around my eyes felt puffy and burning, my lower lip felt puffy, my throat started itching, then I started coughing, then my throat started to feel like it was closing up and I was having trouble breathing by around 1 pm. I started to have hives and my skin was red to the appearance on my chest and arms. I made it to urgent care around 2 pm and they administered a shot of BENADRYL and a shot of a steroid to bring down the inflammation. Within 10 minutes of these being administered, I could breath normally again and my allergy symptoms started to disappear. Then I slept for about 14 hours. The next day I felt like I had flu-like symptoms, hot/cold chills, fever, achy body.
Age: 35.0
Sex: F
Vaccine: FLUC4
Symptoms: Lip swelling, Pain, Pharyngeal oedema, Pyrexia, Throat irritation
Clinical narrative: Within 10-20 min after the shot was administered at 9:40 am, my face started burning and I started feeling dizzy. From approx 10:30 am - 1:30 pm, symptoms progressively got worse. Around my eyes felt puffy and burning, my lower lip felt puffy, my throat started itching, then I started coughing, then my throat started to feel like it was closing up and I was having trouble breathing by around 1 pm. I started to have hives and my skin was red to the appearance on my chest and arms. I made it to urgent care around 2 pm and they administered a shot of BENADRYL and a shot of a steroid to bring down the inflammation. Within 10 minutes of these being administered, I could breath normally again and my allergy symptoms started to disappear. Then I slept for about 14 hours. The next day I felt like I had flu-like symptoms, hot/cold chills, fever, achy body.
Age: 35.0
Sex: F
Vaccine: FLUC4
Symptoms: Urticaria
Clinical narrative: Within 10-20 min after the shot was administered at 9:40 am, my face started burning and I started feeling dizzy. From approx 10:30 am - 1:30 pm, symptoms progressively got worse. Around my eyes felt puffy and burning, my lower lip felt puffy, my throat started itching, then I started coughing, then my throat started to feel like it was closing up and I was having trouble breathing by around 1 pm. I started to have hives and my skin was red to the appearance on my chest and arms. I made it to urgent care around 2 pm and they administered a shot of BENADRYL and a shot of a steroid to bring down the inflammation. Within 10 minutes of these being administered, I could breath normally again and my allergy symptoms started to disappear. Then I slept for about 14 hours. The next day I felt like I had flu-like symptoms, hot/cold chills, fever, achy body.