chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: HPV9
Symptoms: Asthenia, Cough, Erythema, Fatigue, Hypersomnia
Clinical narrative: This spontaneous report as received from a physician via agency refers to a 11 year 9 month old male patient. The patient's medical history, concurrent condition and concomitant medications were not reported. On 21-FEB-2017 the patient was vaccinated with GARDASIL 9 dose 3, intramuscular from lot reported as "024261" for prophylaxis. On 23-FEB-2017, the patient experienced redness, fatigue, pyrexia, cough, pain and injection site swelling. The patient had no energy (asthenia) and sleeps often. The outcome of erythema, hypersomnia, fatigue, asthenia, pyrexia, cough, pain and injection site swelling was reported as recovered/resolved. Causality assessment was not provided. Lot number 024261 is an invalid lot number for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast). Follow up information has been received on 04-DEC-2018 via telephone call from an unspecified reporter from the reporting physician's office. It was reported that the lot number of the GARDASIL 9 dose administered to the patient was M024261 (previously reported as " 024261") with an expiration date in 30-JUL-2018.
Sex: M
Vaccine: HPV9
Symptoms: Injection site swelling, Pain, Pyrexia
Clinical narrative: This spontaneous report as received from a physician via agency refers to a 11 year 9 month old male patient. The patient's medical history, concurrent condition and concomitant medications were not reported. On 21-FEB-2017 the patient was vaccinated with GARDASIL 9 dose 3, intramuscular from lot reported as "024261" for prophylaxis. On 23-FEB-2017, the patient experienced redness, fatigue, pyrexia, cough, pain and injection site swelling. The patient had no energy (asthenia) and sleeps often. The outcome of erythema, hypersomnia, fatigue, asthenia, pyrexia, cough, pain and injection site swelling was reported as recovered/resolved. Causality assessment was not provided. Lot number 024261 is an invalid lot number for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast). Follow up information has been received on 04-DEC-2018 via telephone call from an unspecified reporter from the reporting physician's office. It was reported that the lot number of the GARDASIL 9 dose administered to the patient was M024261 (previously reported as " 024261") with an expiration date in 30-JUL-2018.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse referring to  two patients of unknown age and gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On an unknown date, the patients were vaccinated with improperly stored doses of VARIVAX (strength, dose and route of administration were not reported) (lot # R017642, expiry date: 20-JUN-2020 (also reported as 02-JUL-2020)) for prophylaxis (product storage error). The vaccine was stored in between -14 °C (degrees Celsius) to -10 °C for 6 hours 15 minutes and between -9 °C to 8 °C for 1 hour 45 minutes. There was no previous temperature excursion. No adverse symptoms were reported. No product quality complaint (PQC) was involved. This is a non-valid case due to lack of patient identifiers. Follow up information was received on 06-DEC-2018 from the registered nurse referring to 3 unspecified patients of unknown age and gender. The reporter stated that the temperature excursion had taken place on 08-NOV-2018. The patients received improperly stored doses of VARIVAX on unknown date in November 2018 (reported as between 09-NOV-2018 and 13-NOV-2018). Additionally, the reporter stated that a second temperature excursion took place on 13-NOV-2018 involving the same batches of VARIVAX. Follow up information was received on 10-DEC-2018 from the registered nurse. Upon receipt of follow-up information it was determined that this case is now valid because patient information were updated. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1812USA005348: US-009507513-1812USA005347:
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On 14-NOV-2018, the patient was vaccinated with a dose of VAQTA, which was after its labeled expiration date (25/0.5, lot # N026997, expiration date 10-NOV-2018, intramuscularly) for prophylaxis. No adverse effects were reported.
Age: 74.0
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a other health professional refers to a patient of unknown age. The patient's medical history, concurrent condition and concomitant medications were not reported. On 19-NOV-2018, the patient was vaccinated with improperly stored PNEUMOVAX 23 (dose, strength, frequency, route, were not reported) from lot R018732, expiry date 27-FEB-2020, for prophylaxis. No adverse effects reported.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist regarding a 58-year-old patient of unknown gender. The patient's medical history, concurrent conditions, concomitant medications and drug reaction or allergies were not reported. On 16-AUG-2018, the patient was administered the first dose of RECOMBIVAX HB for prophylaxis (lot #, expiration date, strength, frequency and route of administration were not reported). On 02-NOV-2018, the patient was vaccinated with the second dose of RECOMBIVAX HB for prophylaxis (lot #, expiration date, strength, frequency and route of administration were not reported). No adverse effects were reported.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of product administration
Clinical narrative: This spontaneous report was received from a Nurse referring to a 17 year old female patient. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 20-APR-2016, 12-SEP-2017 and 14-SEP-2018, the patient was vaccinated with first, second and third doses of GARDASIL 9 lot # L040459, expiring on 06-APR-2017, lot # N015087, expiring on 20-OCT-2019 and lot # R008163, expiring on 14-SEP-2018, respectively, for prophylaxis. Lot # L040459 reported for GARDASIL 9 was not valid for GARDASIL 9; However, lot # L040459 was valid for GARDASIL.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse referring to  two patients of unknown age and gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On an unknown date, the patients were vaccinated with improperly stored doses of VARIVAX (strength, dose and route of administration were not reported) (lot # R017642, expiry date: 20-JUN-2020 (also reported as 02-JUL-2020)) for prophylaxis (product storage error). The vaccine was stored in between -14 °C (degrees Celsius) to -10 °C for 6 hours 15 minutes and between -9 °C to 8 °C for 1 hour 45 minutes. There was no previous temperature excursion. No adverse symptoms were reported. No product quality complaint (PQC) was involved. This is a non-valid case due to lack of patient identifiers. Follow up information was received on 06-DEC-2018 from the registered nurse referring to 3 unspecified patients of unknown age and gender. The reporter stated that the temperature excursion had taken place on 08-NOV-2018. The patients received improperly stored doses of VARIVAX on unknown date in November 2018 (reported as between 09-NOV-2018 and 13-NOV-2018). Additionally, the reporter stated that a second temperature excursion took place on 13-NOV-2018 involving the same batches of VARIVAX. Follow up information was received on 10-DEC-2018 from the registered nurse. Upon receipt of follow-up information it was determined that this case is now valid because patient information were updated. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1811USA006380: US-009507513-1812USA005348:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse referring to two patients of unknown age and gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On an unknown date, the patients were vaccinated with improperly stored doses of VARIVAX (strength, dose and route of administration were not reported) (lot # R017642, expiry date: 20-JUN-2020 (also reported as 02-JUL-2020)) for prophylaxis. The vaccine was stored in between -14 °C (degrees Celsius) to -10 °C for 6 hours 15 minutes and between -9 °C to 8 °C for 1 hour 45 minutes. There was no previous temperature excursion. No adverse symptoms were reported. No product quality complaint (PQC) was involved. This is a non-valid case due to lack of patient identifiers. Follow up information was received on 06-DEC-2018 from the registered nurse referring to 3 unspecified patients of unknown age and gender. The reporter stated that the temperature excursion had taken place on 08-NOV-2018. The patients received improperly stored doses of VARIVAX on unknown date in November 2018 (reported as between 09-NOV-2018 and 13-NOV-2018). Additionally, the reporter stated that a second temperature excursion took place on 13-NOV-2018 involving the same batches of VARIVAX. Follow up information was received on 10-DEC-2018 from the registered nurse. Upon receipt of follow-up information it was determined that this case is valid because patient information were updated. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1811USA006380: US-009507513-1812USA005347.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Paralysis
Clinical narrative: Paralysis experienced on November 20 2018. Attempted to get out of car and could not. Had to call ambulance and has been in hospital since Nov 20 until current 12/11. Patient is out of network. Arms and legs affected.
Age: 41.0
Sex: F
Vaccine: FLUC4
Symptoms: Injected limb mobility decreased, Injection site pain, X-ray normal
Clinical narrative: Pain to left deltoid area/shoulder. Unable to elevate arm. Community ER - 11/25/18. X-ray done in ER - employee states was told were negative. Prescribed Ibuprofen 600 mg and FLEXERIL 5 mg.
Age: 18.0
Sex: F
Vaccine: HPV9, MENB, MNQ
Symptoms: Pain in extremity
Clinical narrative: Patient received vaccines at about 11 AM. After returning to our office, I received a call at 3:45 PM from the coordinator at the school campus informing me that the student had been complaining of arm pain. He stated that the student thought the pain was extreme but it was manageable. At 4:15 PM I received another call from him. He informed me that an ambulance had been called to evaluate the student, since there was no medical personnel on campus. EMS came and evaluated the student. She was noted to have very bad pain to her left arm. EMS advised student to apply an ice pack and I confirmed with the informant that this was normal procedure. EMS did not advise any further medical attention and student was taken home by her sister. Informant told me that EMS was called because of the extreme pain student was feeling and because they were not sure if the level of pain was normal. I spoke with student/patient on 12/12/18 and she informed me that she was feeling much better. She stated that she was feeling better by 12/11/18, but still had some pain in her arm. She had not been seen by her doctor or received any further medical attention at this time. I advised patient to seek medical attention if she did not feel well again or if her pain increased.
Age: 24.0
Sex: F
Vaccine: HPV9
Symptoms: Chills, Dyspnoea, Hyperhidrosis, Incomplete course of vaccination, Urticaria
Clinical narrative: This was the clients first injection with GARDASIL 9 as she received GARDASIL-11/07/2012 as her first one (lot # H011350 in Right Deltoid IM thru Family Medicine) this was the first injection received at out clinic. She called the MD on call @ 1935 and reported she "felt like she was having a reaction, reported hives from her Right eye down to her collar bone and reported chills and sweating, feeling slightly SOB. Reported she sent spouse to go get BENADRYL" which she reported she took it. The MD on call encouraged her to go directly to the ER. Patient reported she did not go and felt better after the BENADRYL. I call her 12/13/18 and she reported this to me. I inquired if she remembered having any problems after the first HPV in 2012 and stated "she did not recall any as she was 18 @ the time I received it" I encouraged patient to continue to take BENADRYL or ALLEGRA, CLARITIN as the do not make you drowsy. She is also on ZYRTEC daily. Pt denies any SOB or difficulty swallowing at this time. She feels better. Encouraged to Push PO fluids to help flush this through system. I also informed her that I would advise against getting the last HPV in light of what has happened with the 2nd injection. I informed her I would speak with MD concerning this as well as reporting the adverse reaction to the Vaccine reaction Reporting line. I encouraged her to come in and be seen or if any further problems outside of office hours to go directly to nearest ER. Doctor is in agreement with the above and also not to get the 3rd dose of the HPV vaccine.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Induration, Nodule, Pain in extremity, Peripheral swelling
Clinical narrative: Pt called reporting that her arm was red, swollen, painful and had hard knot the size of grapefruit. Instructed pt to go see her provider to assess this and to let us know the outcome. Also called pt several times and left voice mails asking her to come in and let us see site for documentation purposes. As of this date I do not know what the outcome is.
Age: 38.0
Sex: F
Vaccine: ANTH, TYP
Symptoms: Injected limb mobility decreased, Injection site pain, Pain, Pain in extremity, Paraesthesia
Clinical narrative: Patient was vaccinated at approximately 0900. At 1500 she notified onsite staff of pain and decreased range of motion with her left upper extremity. LUE was swollen. Reported "tingling" sensation in fingers. She was provided an ice pack and was referred to urgent care for follow up. Patient went to an urgent care facility which referred her to a hospital. Hospital recommended alternating heat/cold to the site and prescribed muscle relaxant. On 12/12 I spoke with the patient by phone. She reported that the pain gradually decreased in the days following the vaccination but pain is still present and range of motion is still limited due to pain. She remarked that the site remains tender especially when heat/cold is applied.
Age: 38.0
Sex: F
Vaccine: ANTH, TYP
Symptoms: Peripheral swelling
Clinical narrative: Patient was vaccinated at approximately 0900. At 1500 she notified onsite staff of pain and decreased range of motion with her left upper extremity. LUE was swollen. Reported "tingling" sensation in fingers. She was provided an ice pack and was referred to urgent care for follow up. Patient went to an urgent care facility which referred her to a hospital. Hospital recommended alternating heat/cold to the site and prescribed muscle relaxant. On 12/12 I spoke with the patient by phone. She reported that the pain gradually decreased in the days following the vaccination but pain is still present and range of motion is still limited due to pain. She remarked that the site remains tender especially when heat/cold is applied.
Age: 7.0
Sex: F
Vaccine: FLU4
Symptoms: Underdose
Clinical narrative: Pt given incorrect dose. Pt received the pediatric 0.25 ml dose and is not in the appropriate age group.
Age: 47.0
Sex: F
Vaccine: HEPA
Symptoms: Dizziness, Nausea
Clinical narrative: Dizziness, Queasy.
Age: 66.0
Sex: M
Vaccine: HEPA
Symptoms: Dizziness
Clinical narrative: Lightheaded.
Age: 32.0
Sex: F
Vaccine: FLUR4
Symptoms: Injection site pain, Shoulder injury related to vaccine administration
Clinical narrative: Copied from comment received on 12/12/2018: I went to the Pharmacy on Saturday, October 27, 2018 to receive a flu shot. It was administered by the Pharmacist on-duty (unfortunately, I can't read her signature on my sheet). When she administered the shot, she injected it into my arm. She took no other steps except to just inject the shot into my arm. I noticed pain almost immediately, but per the guidelines on the take-home sheet and my previous experience, I know that vaccine sites can be sore for a few days. What was different this time was that the pain never went away; in fact, it got progressively worse. Two weeks after I was given the vaccine, I was at my physical therapist's office, and mentioned the severe, constant pain in my left arm/shoulder area. I mentioned that the pain's onset coincided with when I received the flu vaccine. He asked me how the shot was administered, and then specifically asked if the pharmacist had pinched my shoulder muscles when administering it. I answered honestly that she had not. My physical therapist then concluded based on my symptoms and description of how the shot was administered that my pain was due to the fact that the vaccine had been improperly administered. He said that the needle had gone through the deltoid muscle, and rather than depositing the vaccine into the muscle, it overshot the muscle and went into the shoulder capsule itself, which is what has caused me so much pain. It's been 6.5 weeks since I had this vaccine, and I still have constant, daily shoulder pain. I have had to go to PT specifically for this issue three times now. I wanted to let you know about this so you could re-educate your staff on how to properly administer vaccines. It's slightly frustrating on my end (to say the least) that all of this could have been avoided with a simple pinch of my arm muscle by your pharmacist. I know you have a high standard for your employees and your brand, and I am sure that you will take appropriate actions so more of your customers don't become injured due to your staff's lack of knowledge.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, concomitant therapies, drug reactions or allergies were not reported. On an unknown date, the patient was vaccinated with VARIVAX, intramuscularly (dose, lot# and expiration date were not reported) for prophylaxis. No adverse symptoms were reported.
Sex: F
Vaccine: HPV4
Symptoms: Amenorrhoea, Balance disorder, Death, Fatigue, Mobility decreased
Clinical narrative: This spontaneous report was received from an other reporter, who posted an information on independent site in social media and refers to a female (also reported as gender unknown) patient of unknown age. The patient's medical history, concurrent conditions and concomitant drugs were not reported. On an unknown date, the patient was vaccinated with GARDASIL (dose, lot#, expiry date, route and site of administration were not reported) for prophylaxis. Other suspect therapies included VIOXX tablets (dose, frequency, lot#, expiry date and indication were not reported). On an unknown dates, the patient experienced difficulty to get out of bed, fatigue (sometimes enormous fatigue), problems with balance and an unspecified other symptoms. She also, on an unknown date, lost her period. On an unknown date, the patient died (also reported as "killed"). Cause of death and information about autopsy were not reported. Action taken with suspected therapies was not reported. The outcome of non-fatal events was unknown. The relatedness between the event and suspected drugs was not reported.
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site mass
Clinical narrative: SMALL, approximately 1 in. DIAMETER, ROUND, PALPABLE, NON-DISCOLORED, LUMP AT SITE OF INJECTION PRESENT FOR NOW 28 DAYS. PATIENT REPORTS NO PAIN DURING PALPATATION.
Age: 1.42
Sex: M
Vaccine: VARCEL
Symptoms: Pyrexia, Staring, Unresponsive to stimuli
Clinical narrative: Mother reported to doctor (reported on 12/10/2018, not immediately after the event) that 7-10 days after the varicella he had low grade fever. Then later had 2 episodes of staring/not responding to voice but eyes open, breathing and normal appearing. Lasted 10-15 seconds. No other symptoms noted and then acted normally. Did not have any movement abnormality. She was concerned it could have be absence seizure though she did not call or report at the time.
Age: 72.0
Sex: M
Vaccine: FLUA3
Symptoms: Injected limb mobility decreased
Clinical narrative: Pt is unable to lift their right arm.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, HIBV
Symptoms: Injection site erythema, Pyrexia, Swelling, Vaccination site pain
Clinical narrative: Patient seen in ER for fever 103.5, swelling, redness and pain at vaccine sites. She was treated with antipyretics and antibiotics. She was doing well when seen at our clinic for follow up. Plan to space vaccines in the future.
Age: 14.0
Sex: M
Vaccine: FLU4, HPV9
Symptoms: Drooling, Electrocardiogram normal, Electroencephalogram abnormal, Electrolyte imbalance, Epilepsy
Clinical narrative: Seizure 1: Patient was having bilateral upper and lower extremity shaking, hands had rhythmic twitching and he was drooling and slumped over. Taken to emergency room, test revealed no apparent reason, referred to neurologist. Neurologist devised testing. MRI of the brain on Feb 2 was normal EEG on February 14, 2016, revealing generalized spike and slow wave discharges activated by hyperventilation and sleep. Second seizure: February 19, 2016, an episode of staring and falling to the ground with tonic-clonic movement lasting 1 minute. Diagnosed with epilepsy and put on KEPPRA 1000 mg b.i.d. and vitamin B6 25 mg daily.
Age: 14.0
Sex: M
Vaccine: FLU4, HPV9
Symptoms: Fall, Flushing, Full blood count normal, Hypertension, Hyperventilation
Clinical narrative: Seizure 1: Patient was having bilateral upper and lower extremity shaking, hands had rhythmic twitching and he was drooling and slumped over. Taken to emergency room, test revealed no apparent reason, referred to neurologist. Neurologist devised testing. MRI of the brain on Feb 2 was normal EEG on February 14, 2016, revealing generalized spike and slow wave discharges activated by hyperventilation and sleep. Second seizure: February 19, 2016, an episode of staring and falling to the ground with tonic-clonic movement lasting 1 minute. Diagnosed with epilepsy and put on KEPPRA 1000 mg b.i.d. and vitamin B6 25 mg daily.
Age: 14.0
Sex: M
Vaccine: FLU4, HPV9
Symptoms: Infection, Metabolic function test normal, Muscle twitching, Nuclear magnetic resonance imaging brain normal, Petechiae
Clinical narrative: Seizure 1: Patient was having bilateral upper and lower extremity shaking, hands had rhythmic twitching and he was drooling and slumped over. Taken to emergency room, test revealed no apparent reason, referred to neurologist. Neurologist devised testing. MRI of the brain on Feb 2 was normal EEG on February 14, 2016, revealing generalized spike and slow wave discharges activated by hyperventilation and sleep. Second seizure: February 19, 2016, an episode of staring and falling to the ground with tonic-clonic movement lasting 1 minute. Diagnosed with epilepsy and put on KEPPRA 1000 mg b.i.d. and vitamin B6 25 mg daily.
Age: 14.0
Sex: M
Vaccine: FLU4, HPV9
Symptoms: Posture abnormal, Seizure, Staring, Tonic clonic movements, Tremor
Clinical narrative: Seizure 1: Patient was having bilateral upper and lower extremity shaking, hands had rhythmic twitching and he was drooling and slumped over. Taken to emergency room, test revealed no apparent reason, referred to neurologist. Neurologist devised testing. MRI of the brain on Feb 2 was normal EEG on February 14, 2016, revealing generalized spike and slow wave discharges activated by hyperventilation and sleep. Second seizure: February 19, 2016, an episode of staring and falling to the ground with tonic-clonic movement lasting 1 minute. Diagnosed with epilepsy and put on KEPPRA 1000 mg b.i.d. and vitamin B6 25 mg daily.
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Abdominal discomfort, Anorectal disorder, Asthenia, Dizziness, Epistaxis
Clinical narrative: Running nose that bled; Sore throat; Weakness; anal leakage; upset stomach; Sweating perfusely; thirst; dizziness.
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Hyperhidrosis, Oropharyngeal pain, Rhinorrhoea, Thirst
Clinical narrative: Running nose that bled; Sore throat; Weakness; anal leakage; upset stomach; Sweating perfusely; thirst; dizziness.
Age: 31.0
Sex: F
Vaccine: TYP
Symptoms: Heart rate increased, Palpitations
Clinical narrative: Pt states HR 100-120 bpm heart palpitations since starting 1st dose of VIVOTIF. Was admitted to ER and received IV fluids. Pt came to store on 12/12/2018 still complaining of increase/abnormal heart rate and heart palpitation. Pt was seen by doctor and instructed to stop the remaining course of VIVOTIF.
Age: 53.0
Sex: F
Vaccine: FLUC4
Symptoms: Mobility decreased, Pain, Swelling
Clinical narrative: PAIN AND SWELLING AND UNABLE TO LIFT ARM.
Age: 1.17
Sex: F
Vaccine: FLU4, HEPA, TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: There was no known adverse event that is known. Instructed to create a VAERS report to track the vaccine error.
Age: 26.0
Sex: M
Vaccine: SMALL
Symptoms: Rash, Rash erythematous, Rash macular
Clinical narrative: 9 days after receiving smallpox vaccine, patient noticed red spots on abdomen and trunk. Pt was seen by MD in the clinic on 12/11/2018. Sparse number of macular rash with raised areas on trunk, in axilla and on arms; without ulceration or exudate expression observed by provider slightly erythematous, not pruritic or expressing fluid. Pt was instructed to monitor for spread or changes in rash. Also was given strict precautions for emergent follow up. Educated patient on continued care of inoculation site.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Anaphylactic shock, Eye inflammation, Headache, Influenza like illness, Malaise
Clinical narrative: This was the second in the series of shots. The first caused mile aches and pains which ended after a day. This time she had Flu-like symptoms including headache, muscular aches, nausea and vomiting, and inflammation of the eyes, tightening of throat. She was so sick that at on December 12, about 24 hour after she got the injection we went to Hospital Urgent Care. They said she was suffering from anaphylactic shock and administered epinephrine and another injection (not sure what it was) and called an ambulance to transport her to Emergency Department. At the ED she was given two IV's and other treatment. After about three hours she was sent home.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Nausea, Pain, Throat tightness, Vomiting
Clinical narrative: This was the second in the series of shots. The first caused mile aches and pains which ended after a day. This time she had Flu-like symptoms including headache, muscular aches, nausea and vomiting, and inflammation of the eyes, tightening of throat. She was so sick that at on December 12, about 24 hour after she got the injection we went to Hospital Urgent Care. They said she was suffering from anaphylactic shock and administered epinephrine and another injection (not sure what it was) and called an ambulance to transport her to Emergency Department. At the ED she was given two IV's and other treatment. After about three hours she was sent home.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood pressure increased, Chest X-ray normal, Electrocardiogram normal, Heart rate increased, Lip pruritus
Clinical narrative: Elevated BP & HR, monitored at work for 1 hr. by healthcare colleagues; sought ED care for onset  of possible anaphylaxis (itching mouth, lips, throat). Treated in ED for ~1 hr. with IV diphenhydramine and steroids.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Oral pruritus, Throat irritation
Clinical narrative: Elevated BP & HR, monitored at work for 1 hr. by healthcare colleagues; sought ED care for onset  of possible anaphylaxis (itching mouth, lips, throat). Treated in ED for ~1 hr. with IV diphenhydramine and steroids.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Discomfort, Influenza like illness, Injection site pain, Middle insomnia, Myalgia
Clinical narrative: Soreness at site and muscle ache. Flu like symptoms and overall body discomfort and ache. Woke up out of sleep that night to vomit.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: Soreness at site and muscle ache. Flu like symptoms and overall body discomfort and ache. Woke up out of sleep that night to vomit.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Fatigue, Headache, Nausea, Paraesthesia, Pyrexia
Clinical narrative: Fatigue, tingling to extremities, fever of 102, headache, and nausea.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Borrelia test negative, Cough, Diarrhoea, Epstein-Barr virus antibody negative, Guillain-Barre syndrome
Clinical narrative: This spontaneous report was received from a physician via a company representative and refers to a 12 year old female patient. The patient's concurrent condition, medical history and concomitant medication were not provided. On 29-NOV-2016 (also reported as about 18 months ago in January), the patient was vaccinated with the first dose of GARDASIL 9, 0.5 milliliter, intramuscularly (lot # and expiry date not reported) for human papilloma virus (HPV) prevention without any side effects after the first dose. The physician stated that on 19-DEC-2016, the patient was seen for viral upper respiratory infection with nasal congestion, cough. On 25-DEC-2016, the patient experienced diarrhoea and vomiting, but was not examined. The physician stated that on 07-JAN-2017, the patient was seen for persistent congestion, headache and temporomandibular joint symptoms. The reporter stated that on 12-JAN-2017 (also reported as about 7-8 months after receiving the vaccine), the patient was seen with muscle aches in lower extremities but had a "normal exam". At that time, blood work was taken and results included "negative Lyme and Epstein Barr Virus (EBV) titers". On 14-JAN-2017, patient went to unknown emergency room (ER) with "objective muscle weakness, decreased Achilles reflexes." At that time, neurology was consulted (clinician not specified) and patient was admitted to unspecified hospital on 20-JAN-2017. The final diagnosis was muscle weakness with "mild" case of Guillain Barre Syndrome. It was reported that neurologic symptoms developed in August or September 2017. The patient was treated with gamma globulin and discharged on 26-JAN-2017. It was also reported that last year mother of the patient refused the second dose of HPV-9 vaccine. The outcome of the events was unknown. The relatedness between the events and suspected vaccine was not provided. Upon internal review, the event of Guillain Barre Syndrome was considered to be medically significant.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Headache, Hyporeflexia, Immunoglobulin therapy, Muscular weakness, Myalgia
Clinical narrative: This spontaneous report was received from a physician via a company representative and refers to a 12 year old female patient. The patient's concurrent condition, medical history and concomitant medication were not provided. On 29-NOV-2016 (also reported as about 18 months ago in January), the patient was vaccinated with the first dose of GARDASIL 9, 0.5 milliliter, intramuscularly (lot # and expiry date not reported) for human papilloma virus (HPV) prevention without any side effects after the first dose. The physician stated that on 19-DEC-2016, the patient was seen for viral upper respiratory infection with nasal congestion, cough. On 25-DEC-2016, the patient experienced diarrhoea and vomiting, but was not examined. The physician stated that on 07-JAN-2017, the patient was seen for persistent congestion, headache and temporomandibular joint symptoms. The reporter stated that on 12-JAN-2017 (also reported as about 7-8 months after receiving the vaccine), the patient was seen with muscle aches in lower extremities but had a "normal exam". At that time, blood work was taken and results included "negative Lyme and Epstein Barr Virus (EBV) titers". On 14-JAN-2017, patient went to unknown emergency room (ER) with "objective muscle weakness, decreased Achilles reflexes." At that time, neurology was consulted (clinician not specified) and patient was admitted to unspecified hospital on 20-JAN-2017. The final diagnosis was muscle weakness with "mild" case of Guillain Barre Syndrome. It was reported that neurologic symptoms developed in August or September 2017. The patient was treated with gamma globulin and discharged on 26-JAN-2017. It was also reported that last year mother of the patient refused the second dose of HPV-9 vaccine. The outcome of the events was unknown. The relatedness between the events and suspected vaccine was not provided. Upon internal review, the event of Guillain Barre Syndrome was considered to be medically significant.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Nasal congestion, Temporomandibular joint syndrome, Viral upper respiratory tract infection, Vomiting
Clinical narrative: This spontaneous report was received from a physician via a company representative and refers to a 12 year old female patient. The patient's concurrent condition, medical history and concomitant medication were not provided. On 29-NOV-2016 (also reported as about 18 months ago in January), the patient was vaccinated with the first dose of GARDASIL 9, 0.5 milliliter, intramuscularly (lot # and expiry date not reported) for human papilloma virus (HPV) prevention without any side effects after the first dose. The physician stated that on 19-DEC-2016, the patient was seen for viral upper respiratory infection with nasal congestion, cough. On 25-DEC-2016, the patient experienced diarrhoea and vomiting, but was not examined. The physician stated that on 07-JAN-2017, the patient was seen for persistent congestion, headache and temporomandibular joint symptoms. The reporter stated that on 12-JAN-2017 (also reported as about 7-8 months after receiving the vaccine), the patient was seen with muscle aches in lower extremities but had a "normal exam". At that time, blood work was taken and results included "negative Lyme and Epstein Barr Virus (EBV) titers". On 14-JAN-2017, patient went to unknown emergency room (ER) with "objective muscle weakness, decreased Achilles reflexes." At that time, neurology was consulted (clinician not specified) and patient was admitted to unspecified hospital on 20-JAN-2017. The final diagnosis was muscle weakness with "mild" case of Guillain Barre Syndrome. It was reported that neurologic symptoms developed in August or September 2017. The patient was treated with gamma globulin and discharged on 26-JAN-2017. It was also reported that last year mother of the patient refused the second dose of HPV-9 vaccine. The outcome of the events was unknown. The relatedness between the events and suspected vaccine was not provided. Upon internal review, the event of Guillain Barre Syndrome was considered to be medically significant.
Sex: U
Vaccine: PPV
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date, the patient was vaccinated with improperly stored dose of PNEUMOVAX 23 (lot # R006466, expiration date: 24-OCT-2019, dose and route of administration were not provided) for prophylaxis. Administered dose of PNEUMOVAX 23 experienced multiple temperature excursion between 47 to 77 Fahrenheit degrees (reported also as 49.1 Fahrenheit degrees) for 40 hours and 30 minutes. No previous temperature excursion was reported. Digital data logger was involved. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1812USA006579.
Sex: U
Vaccine: PPV
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date, the patient was vaccinated with improperly stored dose of PNEUMOVAX 23 (lot # R006466, expiration date: 24-OCT-2019, dose and route of administration were not provided) for prophylaxis. Administered dose of PNEUMOVAX 23 experienced multiple temperature excursion between 47 to 77 Fahrenheit degrees (reported also as 49.1 Fahrenheit degrees) for 40 hours and 30 minutes. No previous temperature excursion was reported. Digital data logger was involved. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1812USA006419.
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Pyrexia, Skin warm, Swelling
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of fever in an adult female patient who received FLULAVAL QUADRIVALENT 2018-2019 season for prophylaxis. On an unknown date, the patient received FLULAVAL QUADRIVALENT 2018-2019 season at an unknown dose. On an unknown date, less than a year after receiving FLULAVAL QUADRIVALENT 2018-2019 season, the patient experienced fever, local swelling, skin warm and localized erythema. On an unknown date, the outcome of the fever, local swelling, skin warm and localized erythema were recovered/resolved. It was unknown if the reporter considered the fever, local swelling, skin warm and localized erythema to be related to FLULAVAL QUADRIVALENT 2018-2019 season. Additional details were provided as follows: The age at the vaccination was not reported. The patient experienced red lump the size of a golf ball, swollen and fever or hot for 3 to 4 days. The reporter was agree to follow up from GlaxoSmithKline.
Sex: M
Vaccine: VARZOS
Symptoms: Axillary pain, Myalgia
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of axillary pain in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced axillary pain and myalgia upper extremities. On an unknown date, the outcome of the axillary pain and myalgia upper extremities were recovered/resolved. It was unknown if the reporter considered the axillary pain and myalgia upper extremities to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient had 30 days of 10 by 10 arm pain in the left axilla, trapezius muscle. The reporter agreed to follow up with GlaxoSmithKline with reporter assistant.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of local swelling in a 74-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (1st dose received in August 2018). In November 2018, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced local swelling and pain in arm. On an unknown date, the outcome of the local swelling and pain in arm were unknown. It was unknown if the reporter considered the local swelling and pain in arm to be related to SHINGRIX. Additional details were reported as follows: The patient received her 1st SHINGRIX injection in August with no side effects. The patient had her 2nd injection early in November 2018 and she still had a bump on her arm and her arm was still sore. The patient had an appointment to see her doctor next month and would inquire about it. The patient was asking is this normal. The patient was asking question regarding how long side effects of SHINGRIX should last. This was all the additional adverse event information provided during the call.
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a female patient who received SHINGRIX for prophylaxis. The patient had a Family History of fall (Fell and cracked head open was bleeding, got knocked out). Previously administered products included ZOSTAVAX with an associated reaction of loss of consciousness. 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 fever and feeling unwell. The patient was treated with paracetamol (Tylenol) and ibuprofen. On an unknown date, the outcome of the fever was recovered/resolved and the outcome of the feeling unwell was unknown. It was unknown if the reporter considered the fever and feeling unwell to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient's past medical history was got ZOSTAVAX injection. The first and second shot were both given in the left arm in the same spot. The patient experienced after receiving the 1st shot in left arm she got a fever and felt sick. She said the fever was 102 degree F and her physician told her to alternate between Tylenol and Ibuprofen. The fever resolved after a day and a half. The reporter did not get permission to contact them. For tolerance to next dose, refer case US2018GSK224418. Lab Comments: On unknown date, Body temperature was measured.
Sex: U
Vaccine: VARZOS
Symptoms: Anxiety, Asthenia, Blood pressure increased, Dizziness
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of loss of energy in a adult patient who received SHINGIRX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGIRX. On an unknown date, less than a year after receiving SHINGIRX, the patient experienced loss of energy, dizziness, increased blood pressure and feeling anxious. On an unknown date, the outcome of the loss of energy, dizziness, increased blood pressure and feeling anxious were recovered/resolved. It was unknown if the reporter considered the loss of energy, dizziness, increased blood pressure and feeling anxious to be related to SHINGIRX. Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. After the 1st shot patient had all the listed adverse events,some lasting for 2 weeks. For tolerance to 2nd dose please refer case US2018GSK225408. Lab Comments: Lab test was done on an unknown date.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of dizziness in a 50-year-old female patient who received Shingles vaccine for prophylaxis. On 3rd December 2018, the patient received Shingles vaccine. In December 2018, less than a week after receiving Shingles vaccine, the patient experienced dizziness. On an unknown date, the outcome of the dizziness was unknown. It was unknown if the reporter considered the dizziness to be related to Shingles vaccine. Additional details were reported as follows: The patient received shingles shot the day before reporting. The patient experienced some mild dizziness. The patient asked how long would this persist.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shingles in a female patient who received SHINGRIX for prophylaxis. On 11th August 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced shingles and blister. On an unknown date, the outcome of the shingles and blister were unknown. It was unknown if the reporter considered the shingles and blister to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient asked how long she need to wait after the last blister to receive the 2nd dose of SHINGRIX.
Sex: U
Vaccine: FLU4
Symptoms: Cough
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of cough in a patient who received Influenza vaccine Quadrivalent 2018-2019 season for prophylaxis. On an unknown date, the patient received Influenza vaccine Quadrivalent 2018-2019 season at an unknown dose. On an unknown date, less than a year after receiving Influenza vaccine Quadrivalent 2018-2019 season, the patient experienced cough. On an unknown date, the outcome of the cough was unknown. It was unknown if the reporter considered the cough to be related to Influenza vaccine Quadrivalent 2018-2019 season. Additional details were provided as follows: The age at vaccination was not reported. Almost 5 weeks ago from the date of reporting, the patient received flu shot. And experienced terrible, horrible hacking and coughing. The patient was not interested in any more vaccines for anything.
Sex: F
Vaccine: VARZOS
Symptoms: Angioedema
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of angioedema in a female patient who received SHINGRIX for prophylaxis. Concomitant products included lisinopril. On an unknown date, the patient received SHINGRIX .5 ml. On an unknown date, unknown after receiving SHINGRIX, the patient experienced angioedema (serious criteria hospitalization and GSK medically significant). On an unknown date, the outcome of the angioedema was unknown. It was unknown if the reporter considered the angioedema to be related to SHINGRIX. Additional information received as follows: The age at vaccination was not reported. The patient experienced angioedema and was hospitalized after vaccination with SHINGRIX. The patient was also on lisinopril however, the patient had been on lisinopril for months without incident. The reporter stated that this was all the information I could get from the provider. The reporter requested to reach out to the office for further information. The reporter agreed to follow up from GlaxoSmithKline.
Sex: M
Vaccine: VARZOS
Symptoms: Bedridden, Chills, Pyrexia, Vaccine positive rechallenge
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of shivering in a 64-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of chills (1st dose received on 23rd May 2018, for tolerance, refer case US2018215061). On 7th November 2018, the patient received the 2nd dose of SHINGRIX. On 8th November 2018, 1 days after receiving SHINGRIX, the patient experienced shivering, fever and bedridden. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the shivering, fever and bedridden were recovered/resolved. It was unknown if the reporter considered the shivering, fever and bedridden to be related to SHINGRIX. Additional details were provided as follows: This case was reported by a physician for himself. The age at vaccination was not reported but it could be 63 or 64 years. The second day after receiving SHINGRIX, the patient experienced shivering, rigor, fever and had to go to bed which lasted 8 hours. The physician consented to follow up.