chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Electromyogram normal, Fatigue, Feeling abnormal, Laboratory test normal, Muscle disorder
Clinical narrative: influenza (nasal spray) and Mencn - ACYW were administered at same time as second dose of HPV Vaccine. November 2014 -  Legs start to tremble during sports.  January 10, 2015 - legs still trembling, low energy, and not feeling good. Advised doctor. Doctor asked for video of leg trembles. May 7 2015 - 3rd and final dose of HPV Vaccine administered. June 4 2015 - legs trembling anytime exercising, lot of muscle pain and run down. Doctor refers to pediatric neurology after seeing video of abnormal leg movement.  June 5, 2015 - Neurology advised unknown Muscle Disease. Summer 2015 - arms and legs start trembling with no exercise. Doctor runs more test - lactic acid levels high. Ran test three times. April 2106 - leg movements become more severe.  Neurologist diagnosed Functional Neurological Disorder with unknown trauma. Patient currently has Movement Disorder involves legs, arms, back, neck, facial muscles, and throat. Limbs can stop working and has loss of speech. Patient has several daily seizures, low energy, and unclear thinking.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Myalgia, Seizure, Thinking abnormal, Tremor, Vitamin D decreased
Clinical narrative: influenza (nasal spray) and Mencn - ACYW were administered at same time as second dose of HPV Vaccine. November 2014 -  Legs start to tremble during sports.  January 10, 2015 - legs still trembling, low energy, and not feeling good. Advised doctor. Doctor asked for video of leg trembles. May 7 2015 - 3rd and final dose of HPV Vaccine administered. June 4 2015 - legs trembling anytime exercising, lot of muscle pain and run down. Doctor refers to pediatric neurology after seeing video of abnormal leg movement.  June 5, 2015 - Neurology advised unknown Muscle Disease. Summer 2015 - arms and legs start trembling with no exercise. Doctor runs more test - lactic acid levels high. Ran test three times. April 2106 - leg movements become more severe.  Neurologist diagnosed Functional Neurological Disorder with unknown trauma. Patient currently has Movement Disorder involves legs, arms, back, neck, facial muscles, and throat. Limbs can stop working and has loss of speech. Patient has several daily seizures, low energy, and unclear thinking.
Age: 5.0
Sex: M
Vaccine: MMRV
Symptoms: Erythema, Rash, Rash pruritic, Skin warm, Swelling
Clinical narrative: Rash started next day when he woke up it was painful and itchy and was warm to touch and swollen. Advised warm packs and can try tylenol if pt uncomfortable. The next day the swelling was improved, but the redness increased in size. Patient returned to clinic for evaluation.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Blood creatine phosphokinase, Full blood count, Injection site pain, X-ray limb
Clinical narrative: Patient reports persistent left deltoid region pain since vaccination (almost 2 years ago now).
Age: 7.0
Sex: F
Vaccine: MMR
Symptoms: Fatigue, Pain, Pyrexia
Clinical narrative: Fever, tiredness, achy.
Age: 18.0
Sex: F
Vaccine: HEPA, HPV9, MENB, MNQ, TDAP
Symptoms: Fall, Head injury, Headache, Laceration, Lip injury
Clinical narrative: Pt had just finished receiving above vaccines, seconds later she lost consciousness and fell forward off of exam table hitting her head on the floor, she had minor injuries of a bump over right eye, small laceration on her nose and bite her lip-had blood in her mouth. Father was called to come get her, we advised him to take to ER to check for possible concussion. She did admit to nausea but was oriented to person, place and time. She regained consciousness after approximately 45 seconds. Pt stated she did not remember getting the shot or feeling dizzy before she passed out. BP at 11:50 was 140/90. She was then assisted to sit up and then to wheelchair. Pt did complain of severe headache and tingling in both hands, denied vision changes. Pt taken to her father's car via wheelchair and again he was instructed to take her to ER. Treatment with ice pack to bump on head.
Age: 18.0
Sex: F
Vaccine: HEPA, HPV9, MENB, MNQ, TDAP
Symptoms: Loss of consciousness, Nausea, Paraesthesia
Clinical narrative: Pt had just finished receiving above vaccines, seconds later she lost consciousness and fell forward off of exam table hitting her head on the floor, she had minor injuries of a bump over right eye, small laceration on her nose and bite her lip-had blood in her mouth. Father was called to come get her, we advised him to take to ER to check for possible concussion. She did admit to nausea but was oriented to person, place and time. She regained consciousness after approximately 45 seconds. Pt stated she did not remember getting the shot or feeling dizzy before she passed out. BP at 11:50 was 140/90. She was then assisted to sit up and then to wheelchair. Pt did complain of severe headache and tingling in both hands, denied vision changes. Pt taken to her father's car via wheelchair and again he was instructed to take her to ER. Treatment with ice pack to bump on head.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Asthenia, Blood test normal, Blood urine present, Chest X-ray normal, Hyperhidrosis
Clinical narrative: Fever and sweating and weakness evening after vaccine. 08/08/2017 01:28 PM Pt's mom states pt got his last HPV shot yesterday. About 6:00pm pt c/o feeling weak. Pt spiked a fever of 104.1 and was taken to the ER about midnight. Pt had BW, u/a and chest xray. The only thing abnormal was a trace of blood in his urine. Pt was given a bag of fluids and sent home. Pt's fever today is running 102.3. Pt's mom is alternating TYLENOL and MOTRIN. Please advise. 08/08/2017 05:38 PM I spoke with mom this evening. Highest fever was 104.1 last evening and highest today 102.3. It comes down for a while with TYLENOL. He has sweats with the fever. ED evaluation turned up no other cause for the fever and they and I do suspect this is an adverse reaction to the GARDASIL. This was his 3rd dose, so he is finished with it. We should report this to the FDA and possible the vaccine manufacturer. Thanks. 08/16/2017 09:35 PM Vaccine reaction reported to VAERS. Report form faxed.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Pyrexia, Vaccination complication
Clinical narrative: Fever and sweating and weakness evening after vaccine. 08/08/2017 01:28 PM Pt's mom states pt got his last HPV shot yesterday. About 6:00pm pt c/o feeling weak. Pt spiked a fever of 104.1 and was taken to the ER about midnight. Pt had BW, u/a and chest xray. The only thing abnormal was a trace of blood in his urine. Pt was given a bag of fluids and sent home. Pt's fever today is running 102.3. Pt's mom is alternating TYLENOL and MOTRIN. Please advise. 08/08/2017 05:38 PM I spoke with mom this evening. Highest fever was 104.1 last evening and highest today 102.3. It comes down for a while with TYLENOL. He has sweats with the fever. ED evaluation turned up no other cause for the fever and they and I do suspect this is an adverse reaction to the GARDASIL. This was his 3rd dose, so he is finished with it. We should report this to the FDA and possible the vaccine manufacturer. Thanks. 08/16/2017 09:35 PM Vaccine reaction reported to VAERS. Report form faxed.
Age: 80.0
Sex: U
Vaccine: PPV
Symptoms: Cellulitis, Pain
Clinical narrative: Sore. Cellulitis.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site oedema, Injection site pruritus, Injection site warmth
Clinical narrative: Redness, edema, and local hot and itchy in the left upper arm in deltoid area, no fever or other symptom.
Age: 13.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site inflammation, Injection site warmth, Pain
Clinical narrative: Patient was brought to the clinic by his grandmother. Patient reported his right arm hurt when he moved it. The arm was red, warm, with slight inflammation over the right deltoid muscle.  Grandmother reported they applied ice the previous evening, but nothing since and no Tylenol or ibuprofen or other analgesic was taken by the patient. Was advised to continue with cold compress, increase movement as much as possible, and to take an age appropriate dose of Tylenol or IB if desired. Grandmother was advised to monitor the arm and if increased swelling or discomfort continues, to contact us immediately. That was two days ago and we have not heard anything further concerning this patient.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Erythema, Urticaria
Clinical narrative: The patient had facial hives, facial redness and was scratching her face after MMRV. MD was notified and orders to give Benadryl PO. The patient was observed in office for about 45 min The patient remained alert and oriented throughout.
Age: 1.17
Sex: M
Vaccine: MMRV
Symptoms: Blood glucose normal, Blood test, Chest X-ray normal, Febrile convulsion, Hypotonia
Clinical narrative: On 8/16/2017 8 days after receiving the MMRV shot he had a febrile seizure. There were not any signs or symptoms that day leading up to the seizure. He ate and drank normally all day and around 6:30 he had a febrile seizure and went limp. 911 was called and he was taken to the hospital his fever spiked to 103.4. He was given Tylenol and Motrin until the fever broke. We had a follow up appointment on 8/17/2017 and the Nurse Practitioner believed that this was a result from receiving the MMRV shot and suggested a report to be filed.
Age: 1.17
Sex: M
Vaccine: MMRV
Symptoms: Pyrexia
Clinical narrative: On 8/16/2017 8 days after receiving the MMRV shot he had a febrile seizure. There were not any signs or symptoms that day leading up to the seizure. He ate and drank normally all day and around 6:30 he had a febrile seizure and went limp. 911 was called and he was taken to the hospital his fever spiked to 103.4. He was given Tylenol and Motrin until the fever broke. We had a follow up appointment on 8/17/2017 and the Nurse Practitioner believed that this was a result from receiving the MMRV shot and suggested a report to be filed.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Cellulitis, Erythema, Swelling
Clinical narrative: Received TRUMENBA on 8/16/17 in left arm. Developed redness swelling and pain on arm below site of injection since yesterday. No fever. Cellulitis of left upper extremity. Clindamycin (CLEOCIN) 300 MG capsule; Take 1 capsule by mouth 3 times daily for 7 days.
Age: 58.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Immediate post-injection reaction, Injection site pain, Injection site swelling, Limb discomfort
Clinical narrative: May 12th received a tetanus shot. Immediately pain and swelling. Bad headache for 3 days then pain upon raising my arm. Pain radiates to the shoulder. Pain at nite when trying to sleep. Pain throughout the day, sometimes severe. Start physical therapy 7/19/17. Ache all over.
Age: 58.0
Sex: F
Vaccine: TDAP
Symptoms: Musculoskeletal pain, Osteoarthritis, Pain, Pain in extremity, X-ray limb abnormal
Clinical narrative: May 12th received a tetanus shot. Immediately pain and swelling. Bad headache for 3 days then pain upon raising my arm. Pain radiates to the shoulder. Pain at nite when trying to sleep. Pain throughout the day, sometimes severe. Start physical therapy 7/19/17. Ache all over.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received on 15-AUG-2017 from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Medical history, concurrent conditions, and concomitant medications were not provided. On or about 02-DEC-2013, the patient was inoculated with ZOSTAVAX (dose, route of administration, site of administration and lot # and expiration date were not provided) at a medical center pharmacy (by an unspecified person) for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 11-APR-2016, she was treated by a physician/MD at a family medicine office for the onset of a severe vesicular eruption accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. The female patient has been prescribed VALTREX for treatment of her painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was not resolved. The lawyer felt the events were related to ZOSTAVAX. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information was received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's medical history, concurrent conditions or concomitant medications. On or about 01-OCT-2015, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration unknown), as recommended for routine adult health maintenance and for the prevention of shingles. It was reported that the vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 06-JUL-2016, the patient was treated at the emergency department of a hospital for the onset of a severe vesicular eruption accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster. The patient was prescribed VALTREX for the management of his painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information was received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's medical history, concurrent conditions or concomitant medications. On or about 19-SEP-2012, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration unknown) as recommended for routine adult health maintenance and the prevention of shingles. It was reported that the vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 25-MAR-2013, the patient was treated by a nurse practitioner at a heart and vascular center for the onset of a severe vesicular eruption accompanied by weakened immune symptoms, which was diagnosed as herpes zoster. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse, referring to 40 unspecified patients of unknown gender and age. No information regarding the patients' concomitant medications, pertinent medical histories and drug reactions or allergies was provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # N004799, expiration date: 15-NOV-2019 (dose and route of administration were not reported). No adverse effects were reported. It was reported that the vaccines were exposed to the temperature of 12.2 Celsius degrees for a time frame of 37 minutes. The temperature excursion was recorded by a digital data logger and the previous excursion was reported as 9.3 Celsius degrees for 16 minutes for the vaccines. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1708USA008138: US-009507513-1708USA008139: US-009507513-1708USA008140: US-009507513-1708USA008141.
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain, Anxiety, Burning sensation, Emotional distress, Injury
Clinical narrative: Information has been received on 16-AUG-2017 regarding a case in litigation from a lawyer and a female patient of unknown age and the patient's spouse. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown date the patient was vaccinated with ZOSTAVAX (lot number and expiration not reported), subcutaneous for its intended purpose of the prevention of shingles. Weeks later (date not reported), the patient began to experience prickling in her legs and feet, stabbing pains in her abdomen, and muscle stiffness. On an unknown date, the patient was eventually diagnosed with postherpetic neuralgia as a result of the ZOSTAVAX vaccine. The patient continues to experience chronic prickling and tingling, some stabbing pains, and burning feelings in different spots on her body. As a direct and proximate result of the ZOSTAVAX vaccine, the patient's symptoms have resulted in physical limitations not present prior to using ZOSTAVAX. The patient also experiences mental and emotional distress due to resulting physical limitations from, and seriousness of, her condition. As a result of 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. The patient has incurred and will continue to incur medical expenses and other economic harm as a direct result of use of ZOSTAVAX. Postherpetic neuralgia, stabbing pains in her abdomen, and muscle stiffness were considered to be disabling. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Musculoskeletal stiffness, Paraesthesia, Physical disability, Post herpetic neuralgia, Quality of life decreased
Clinical narrative: Information has been received on 16-AUG-2017 regarding a case in litigation from a lawyer and a female patient of unknown age and the patient's spouse. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown date the patient was vaccinated with ZOSTAVAX (lot number and expiration not reported), subcutaneous for its intended purpose of the prevention of shingles. Weeks later (date not reported), the patient began to experience prickling in her legs and feet, stabbing pains in her abdomen, and muscle stiffness. On an unknown date, the patient was eventually diagnosed with postherpetic neuralgia as a result of the ZOSTAVAX vaccine. The patient continues to experience chronic prickling and tingling, some stabbing pains, and burning feelings in different spots on her body. As a direct and proximate result of the ZOSTAVAX vaccine, the patient's symptoms have resulted in physical limitations not present prior to using ZOSTAVAX. The patient also experiences mental and emotional distress due to resulting physical limitations from, and seriousness of, her condition. As a result of 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. The patient has incurred and will continue to incur medical expenses and other economic harm as a direct result of use of ZOSTAVAX. Postherpetic neuralgia, stabbing pains in her abdomen, and muscle stiffness were considered to be disabling. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event
Clinical narrative: This spontaneous report as received from a nurse concerning unspecified number of patients of unknown age and gender. Approximately in 2017 (reported as between 30-MAY-2017 and 16-AUG-2017), the patients were vaccinated with improperly stored ZOSTAVAX vial 19400 PFU (plaque-forming units) lot # M042850 with expiry date: 18-JAN-2018 (dosing details unknown) for prophylaxis. The vaccines were reconstituted with properly stored sterile diluent (lot# unknown). It was reported that the vaccines were exposed to a temperature range of 15F to 46F for a duration of 1 hour. During the previous temperature excursion the vaccines were exposed to a temperature range of 15F to 46F for a duration of 1 hour. Data logger was involved. No adverse effects were reported. There were no product quality complaints. Sender's Comments: US-009507513-1708USA008039: US-009507513-1708USA008040.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain, Scar
Clinical narrative: This spontaneous report as received from a consumer refers to herself, a female patient of unknown age. The patient's medical history, concurrent condition and concomitant medications were not reported. On an unknown date the patient was vaccinated with ZOSTAVAX (frequency, route, lot # and expiry date were not reported) for prophylaxis. She reported that after receiving ZOSTAVAX, in June (year unspecified), that she came down with the shingles. She stated that this was "sheer suffering, the air hurt and spent days in agony". She noted that her blisters would weep fluid and she would have to put pads under her breast to absorb the fluid. She noted that some of her blisters were 2 inches by 4 inches and they did not resolve until February the following year. She states that she now has scars from the blisters. No treatment was given to adverse events. The outcome of herpes zoster was reported as recovered. The outcome of vaccination failure and emotional distress was unknown. The outcome of scar was considered to be not recovered. Causality assessment was not provided. No further information was obtained. No PQC filed. Therefore no VZV packet sent.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant concerning unspecified patients of unknown age and gender. No concurrent conditions, medical history and allergy/drug reactions were reported. Approximately in 2017 (reported as between 01-JUL-2017 to 16-AUG-2017) the patients were vaccinated with improperly stored PROQUAD lot # N002917 with expiry date: 24-JUL-2019 (dosing details, anatomical location and route were unknown) for prophylaxis. Concomitant therapy included sterile diluent (MERCK) (no details provided). It was reported that the vaccines were exposed to a temperature range of 6F to 14 F for a duration of 1 hour 59 minutes. There was no previous temperature excursion. Data logger was involved. No adverse effects were reported. There were no product quality complaints. This is one of the two reports received from the same reporter. Sender's Comments: US-009507513-1708USA008268.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse concerning unspecified number of patients of unknown age and gender. Approximately in 2017 (reported as between 30-MAY-2017 and 16-AUG-2017), the patients were vaccinated with improperly stored VARIVAX lot # M031969 for with expiry date: 30-JUN-2018 (dosing details unknown) for prophylaxis. The vaccines were reconstituted with properly stored sterile diluent (lot# unknown). It was reported that the vaccines were exposed to a temperature range of 15F to 46F for a duration of 1 hour. During the previous temperature excursion the vaccines were exposed to a temperature range of 15F to 46F for a duration of 1 hour. Data logger was involved. No adverse effects were reported. There were no product quality complaints. Sender's Comments: US-009507513-1708USA007720: US-009507513-1708USA008040.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse concerning unspecified number of patients of unknown age and gender. Approximately in 2017 (reported as between 30-MAY-2017 and 16-AUG-2017), the patients were vaccinated with improperly PROQUAD lot # M038861 with expiry date: 13-MAR-2018 (dosing details unknown) for prophylaxis. The vaccines were reconstituted with properly stored sterile diluent (lot# unknown). It was reported that the vaccines were exposed to a temperature range of 15F to 46F for a duration of 1 hour. During the previous temperature excursion the vaccines were exposed to a temperature range of 15F to 46F for a duration of 1 hour. Data logger was involved. No adverse effects were reported. There were no product quality complaints. Sender's Comments: US-009507513-1708USA007720: US-009507513-1708USA008039.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse, referring to 40 unspecified patients of unknown gender and age. No information regarding patients' concomitant medications, pertinent medical histories and drug reactions or allergies was provided. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB lot# N002202, expiration date 04-NOV-2019 and lot# N006321, expiration date 08-NOV-2019 (dose and route of administration were not reported). No adverse effects were reported. It was reported that the vaccines were exposed to the temperature of 12.2 Celsius degrees for a time frame of 37 minutes. The temperature excursion was recorded by a digital data logger and the previous excursions was reported as 9.3 Celsius degrees for 16 minutes for the vaccines. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1708USA007367: US-009507513-1708USA008138: US-009507513-1708USA008140: US-009507513-1708USA008141.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse, referring to 40 unspecified patients of unknown gender and age. No information regarding the patients' concomitant medications, pertinent medical histories and drug reactions or allergies was provided. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ orally, lot # M042170, expiration date: 22-JUN-2018 and lot #M044397, expiration date: June 2018 (dose was not reported). No adverse effects were reported. It was reported that the vaccines were exposed to the temperature of 12.2 Celsius degrees for a time frame of 37 minutes. The temperature excursion was recorded by a digital data logger and the previous excursion was reported as 9.3 Celsius degrees for 16 minutes for the vaccines. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1708USA007367: US-009507513-1708USA008138: US-009507513-1708USA008139: US-009507513-1708USA008141.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse, referring to 40 unspecified patients of unknown gender and age. No information regarding the patients' concomitant medications, pertinent medical histories and drug reactions or allergies was provided. On unknown dates, the patients were vaccinated with improperly stored doses of VAQTA lot# N005274, expiration date: 03-APR-2018 and lot# N008823 and expiration date: 26-MAY-2018 (dose and route of administration were not reported). No adverse effects were reported. It was reported that the vaccines were exposed to the temperature of 12.2 Celsius degrees for a time frame of 37 minutes. The temperature excursion was recorded by a digital data logger and the previous excursion was reported as 9.3 Celsius degrees for 16 minutes for the vaccines. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1708USA007367: US-009507513-1708USA008138: US-009507513-1708USA008139: US-009507513-1708USA008140.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant concerning unspecified patients of unknown age and gender. No concurrent conditions, medical history and allergy/drug reactions were reported. Approximately in 2017 (reported as between 01-JUL-2017 to 16-AUG-2017) the patients were vaccinated with improperly stored VARIVAX lot # N000681 with expiry date: 05-JAN-2019 (dosing details, anatomical location and route were unknown) for prophylaxis. Concomitant therapy included MERCK STERILE DILUENT (no details provided). It was reported that the vaccines were exposed to a temperature range of 6F to 14 F for a duration of 1 hour 59 minutes. There was no previous temperature excursion. Data logger was involved. No adverse effects were reported. There were no product quality complaints. This is second of the two reports received from the same reporter. Sender's Comments: US-009507513-1708USA007795.
Age: 67.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Pain in extremity, Skin warm
Clinical narrative: This is a spontaneous report received from a contactable pharmacist and consumer. A 67-year-old female patient received PREVNAR 13 (lot number: R28322, expiry date: 31Mar2018), intramuscular on 10Aug2017 at 0.5 ml, single and influenza vaccine (manufacturer unknown), via an unspecified route of administration on 10Aug2017 at 1 DF, single both for immunisation. Medical history included thyroid problem, Alzheimer's disease and memory issue. Concomitant medication included ongoing levothyroxine at 50 mcg once daily for thyroid problem which the patient has been taking for 3 years and ongoing memantine at 5 mg once daily for Alzheimer's disease and memory issues. On 10Aug2017, the patient reported that her arm was hurting and warm to touch. The patient got pneumococcal 13-val conj vac (dipht crm197 protein) and flu shot but on opposite arms and was saying that the pneumonia arm was hurting and warm to the touch. The patient was advised to take ibuprofen and was applying ice pack. The outcome of the event was not recovered at the time of report.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Skin swelling, Skin warm, Swelling, Vaccination site erythema
Clinical narrative: 15 cm x 5 cm red raised warm skin below vaccination site with light erythema of the whole upper arm. PEPCID 40 mg x 7. Loratadine 10 mg x 7. KELFEX 500 TID x 7.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: None listed.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Peripheral swelling, Pruritus, Rash, Skin warm
Clinical narrative: Pt had shingles vaccine on 8/7/17. Next morning arm red, warm, and slightly swollen. Itching. Today arm is the same bright red, warm and rash. Not getting any worse. Cold compress to area and BENADRYL BID x 2 days. To call back if does not continue to improve.
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Pain, Pain in extremity
Clinical narrative: This case was reported by a nurse and described the occurrence of pain in arm in a 55-year-old female patient who received BOOSTRIX (batch number 7Z9Z5, expiry date 27th May 2019). On 9th June 2017, the patient received BOOSTRIX. On 9th June 2017, less than a day after receiving BOOSTRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown. It was unknown if the reporter considered the pain in arm to be related to BOOSTRIX. Additional details were provided as follows: Since the date of vaccination, the patient experienced soreness in left deltoid with above shoulder movement. The batch number reported for BOOSTRIX 72925 (or 729Z5?) did not exist and was updated to 7Z9Z5, as per sales database.
Age: 17.0
Sex: M
Vaccine: HEPA, HPV9, MENB
Symptoms: Immediate post-injection reaction, Loss of consciousness
Clinical narrative: I gave him the shot in the right arm after giving a Hepatitis A and BEXSERO in the L arm without incident. He said HPV hurt and he passes out immediately. He came to in 5 minutes but was not stable for 17-80 minutes. He recovered.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site reaction, Injection site warmth, Livedo reticularis
Clinical narrative: Immediately after vaccine delivered, the deltoid became red, mottled and slightly warm. It was not painful, not swollen. 25 mg of BENADRYL was given PO and reaction resolved within 15 minutes.
Age: 16.0
Sex: M
Vaccine: HEPA, HPV9, MENB
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Fever unresolved by medication, redness and swelling at injection site, warm to touch.
Age: 73.0
Sex: F
Vaccine: FLU3, PPV, FLU4, PPV, FLU3, PPV
Symptoms: Cellulitis, Erythema, Injection site erythema
Clinical narrative: Patient received both immunizations on 8/15/17. According to patient her arm started getting red 'a couple of hours after immunization'. Did not seek medical attention until 8/17/17 when her right arm was red from the armpit to her wrist. At that time she went Medical Center Emergency Department. Patient states she was diagnosed with cellulitis. Was not admitted to the hospital was released from the ED on 8/18/17 with a prescription for Bactrim DS. This pharmacy provided her with the generic. Redness had subsided and was clearly visible on the inside of her arm from the armpit to just above the elbow.
Age: 73.0
Sex: F
Vaccine: FLU3, PPV, FLU4, PPV, FLU3, PPV
Symptoms: Cellulitis, Injection site erythema
Clinical narrative: Patient received both immunizations on 8/15/17. According to patient her arm started getting red 'a couple of hours after immunization'. Did not seek medical attention until 8/17/17 when her right arm was red from the armpit to her wrist. At that time she went Medical Center Emergency Department. Patient states she was diagnosed with cellulitis. Was not admitted to the hospital was released from the ED on 8/18/17 with a prescription for Bactrim DS. This pharmacy provided her with the generic. Redness had subsided and was clearly visible on the inside of her arm from the armpit to just above the elbow.
Age: 73.0
Sex: F
Vaccine: FLU3, PPV, FLU4, PPV, FLU3, PPV
Symptoms: Erythema, Injection site pain
Clinical narrative: Patient received both immunizations on 8/15/17. According to patient her arm started getting red 'a couple of hours after immunization'. Did not seek medical attention until 8/17/17 when her right arm was red from the armpit to her wrist. At that time she went Medical Center Emergency Department. Patient states she was diagnosed with cellulitis. Was not admitted to the hospital was released from the ED on 8/18/17 with a prescription for Bactrim DS. This pharmacy provided her with the generic. Redness had subsided and was clearly visible on the inside of her arm from the armpit to just above the elbow.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Pruritus, Rash
Clinical narrative: Itching and rash.
Age: 4.0
Sex: M
Vaccine: DTAP, MMRV
Symptoms: Facial paresis, Injection site swelling, Injection site warmth, Swelling face
Clinical narrative: Swelling and fever in the top muscle on the left arm. Swelling on the right of face and weakness.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Crying, Dizziness, Erythema, Fatigue, Injection site pain
Clinical narrative: Mom states that patient c/o fatigue, arm pain at injection site, mild dizziness about 12hours after injection. Early AM following day patient c/o not being able to lift arm and extreme pain. Pt arm was warm to touch, red and pt states she could not move arm and it hurts bad enough that pt was crying.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Mobility decreased, Pain in extremity, Skin warm
Clinical narrative: Mom states that patient c/o fatigue, arm pain at injection site, mild dizziness about 12hours after injection. Early AM following day patient c/o not being able to lift arm and extreme pain. Pt arm was warm to touch, red and pt states she could not move arm and it hurts bad enough that pt was crying.
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Joint range of motion decreased, Pain in extremity
Clinical narrative: Arm sore, limited range of motion.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP, UNK
Symptoms: Vaccination complication
Clinical narrative: Adverse effect of vaccines and biological substances, init on 2017-08-10.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Mother stated that she noted swelling and redness on the child right arm the day after the vaccine received. And then noted it has gotten bigger in size( about 5 inches length and 2 inches width) . Seen by Dr.at the clinic on 08/18/17 and advised to put ice to the area, Benadryl and Motrin to give according to the instruction on the label.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Dyskinesia, Electroencephalogram abnormal, Generalised tonic-clonic seizure, Juvenile myoclonic epilepsy, Nuclear magnetic resonance imaging
Clinical narrative: Shortly after receiving the shot, she started experiencing jerks that I had no idea what that was.  On April 17th around 6am, patient had a seizure(Grand mal); she then had EEG and MRI. She was diagnosed with Juvenile Myclonic Epilepsy after the EEG. She is now on medication Lamintringe that she takes everyday. I recently found out that Seizures where an adverse affect in some girls.  My child was healthy before this shot, neve had any problems. The doctor didn't even tell me about any side affects from the shot. I am very concerned that this drug cause this reaction in my child. She seems to be doing fine. My daughter is very athletic. Plays volleyball and runs track. Not sure how long this will go on and how long she will have to be on medication. I do not want this shot given to her ever again. What do I need to do?
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Erythema, Peripheral swelling, Pruritus
Clinical narrative: Patient parent states that child was seen at Emergency Room 24 hours after receiving vaccines on August 17, 2017 due to localized swelling, redness, and localized itching of right arm. Parent states no cold compresses were used prior to visit to ER. During visit at hospital, parent states medical staff applied cold compress to child's right arm and administered Benadryl. Patient discharged from ER at 2:29 PM August 18, 2017. Post discharge prescription for Benadryl 25 mg given to patient from ER.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth, Peripheral swelling
Clinical narrative: Left Deltoid to mid arm swelling, redness, warmth, itching.
Age: 13.0
Sex: F
Vaccine: MNQ
Symptoms: Urticaria
Clinical narrative: Patient experienced an outbreak of hives all over her body 8-10 hours after receiving vaccine.
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Cold sweat, Hyperhidrosis, Pallor, Presyncope
Clinical narrative: About 5 min after injection, patient has had a vasovagal accident, near Syncope, denies loss of consciousness. Clammy, sweaty and pale. Pt laid down with legs elevate, ice pack and apple juice. VS taken and provider assesses pt within 5 min and patient return to normal after. PT dc with no acute distress.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discomfort, Injection site erythema, Injection site warmth
Clinical narrative: Patient experienced redness and warmth around injection site. Patient states from injection site down to elbow the area is achy when touched.
Age: 16.0
Sex: F
Vaccine: HEPA, HPV9, IPV, MENB, VARCEL
Symptoms: Oedema, Pain in extremity, Peripheral swelling
Clinical narrative: Tele call from Mother to clinic stating patient has aching and swelling in her feet and legs that indents since about 2 days after receiving vaccines on 08/08/2017. Mom instructed to contact PMD, and to have patient seen at after hours clinic or Urgent Care if unable to see PMD. Mom will relay results of visit.
Age: 1.17
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Injection site erythema, Rash
Clinical narrative: Red rash started on patient's face. Red at injection site.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Loss of consciousness
Clinical narrative: Pt passed out after immunization.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Developed zoster (shingles).
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Peripheral swelling, Pruritus
Clinical narrative: Itching "from the inside out", hands and palms very itchy, swelling in hands.
Age: 4.0
Sex: F
Vaccine: DTAP, MMRV
Symptoms: Injection site cellulitis, Injection site erythema, Injection site swelling, Injection site vesicles, Injection site warmth
Clinical narrative: On Friday 8/11/2017 patient had the MMRV vaccination given subcutaneously in her left arm. On Saturday morning there were some blisters forming, some redness, and it was warm to the touch. Patient had a fever of 100.6, that was resolved with Motrin. To monitor the redness/swelling I drew a circle around the area. On Sunday morning the blisters were open. The redness and swelling spread beyond the circle almost extending from her shoulder to elbow. At that point I brought her in to the E.R. to be evaluated. The Doctor examined her arm and determined that she had cellulitis caused by the injection. He ordered Keflex three times a day for 7 days. Today, Friday 8/18/2017 the injection site looks much better. The redness and swelling is gone and the blisters are healing up nicely.
Age: 4.0
Sex: F
Vaccine: DTAP, MMRV
Symptoms: Pyrexia
Clinical narrative: On Friday 8/11/2017 patient had the MMRV vaccination given subcutaneously in her left arm. On Saturday morning there were some blisters forming, some redness, and it was warm to the touch. Patient had a fever of 100.6, that was resolved with Motrin. To monitor the redness/swelling I drew a circle around the area. On Sunday morning the blisters were open. The redness and swelling spread beyond the circle almost extending from her shoulder to elbow. At that point I brought her in to the E.R. to be evaluated. The Doctor examined her arm and determined that she had cellulitis caused by the injection. He ordered Keflex three times a day for 7 days. Today, Friday 8/18/2017 the injection site looks much better. The redness and swelling is gone and the blisters are healing up nicely.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a physician referring to a 62 year old female patient. On an unknown date the patient was vaccinated with ZOSTAVAX for prophylaxis. On an unknown date the patient experienced herpes zoster. The outcome of herpes zoster was reported as recovered/resolved.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse referring to an unspecified number of patients of an unknown age and genders. On an unknown dates, the patients were vaccinated with an improperly stored dose of GARDASIL 9, lot # M042853 for prophylaxis. The administered dose of the vaccine experienced a temperature excursion 0 degrees Celsius to 1 degrees Celsius  for 97 hours, and -1 degrees Celsius to -40 Celsius  for 8.5 min as recorded by a data logger. There was no adverse effect reported. No product quality complaint was involved.
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Burning sensation, Hypoaesthesia, Musculoskeletal pain, Pain
Clinical narrative: Burning, searing pain upon administration. Lingering dull pain and numbness in shoulder (upper and back), outer bicep, and elbow. Sometimes radiates down outer forearm to hand. Most noticeable when I'm typing or sitting down. I still have range of motion, but the "achiness is bothersome". It is day 10 and I still have aches. I plan on seeing my doctor next week if pain continues over the weekend.
Age: 1.08
Sex: F
Vaccine: MMR
Symptoms: Pyrexia, Vomiting
Clinical narrative: Throwing up with fever.
Age: 19.0
Sex: F
Vaccine: FLUC4
Symptoms: Urticaria
Clinical narrative: Patient had hives all over the body.
Age: 70.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Chills, Injection site pain, Limb discomfort, Pain, Pyrexia
Clinical narrative: I had two shots in one sitting one was Pneumococcal Polysaccharide Vaccine. The other was the seasonal flu vaccine for 2017 but I don't know the particular name of it. After about 5 hours, I had severe pain in my left arm at the site of the two injections. It was a throbbing aching pain. This prevented me from sleeping so I took 250mm Ibuprofen. During the night, I experienced chills and fever and disturbed sleep. By morning I felt better however my arm is still sore to the touch at the injection site though I no longer have the throbbing aching pain.
Age: 70.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Sleep disorder
Clinical narrative: I had two shots in one sitting one was Pneumococcal Polysaccharide Vaccine. The other was the seasonal flu vaccine for 2017 but I don't know the particular name of it. After about 5 hours, I had severe pain in my left arm at the site of the two injections. It was a throbbing aching pain. This prevented me from sleeping so I took 250mm Ibuprofen. During the night, I experienced chills and fever and disturbed sleep. By morning I felt better however my arm is still sore to the touch at the injection site though I no longer have the throbbing aching pain.