chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse concerning to a 3 unspecified patients of unknown ages and gender. The patient's pertinent medical history and concurred conditions were not reported. On an unknown dates, the patients were vaccinated with improperly stored doses of M-M-R II (lot # L003859, expiration date on 05-FEB-2017, (doses were not reported). No adverse effects reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Eye irritation, Eye swelling, Oropharyngeal pain, Pain in extremity
Clinical narrative: Joint pain behind left knee started 6/25/16. Joint pain moved to right knee, left thumb right hand, right thumb on 6/26/16. Also, on 6/26, she had rash across cheeks, burning eyes, swollen and sore throat.
Age: 61.0
Sex: F
Vaccine: MMR
Symptoms: Rash
Clinical narrative: Joint pain behind left knee started 6/25/16. Joint pain moved to right knee, left thumb right hand, right thumb on 6/26/16. Also, on 6/26, she had rash across cheeks, burning eyes, swollen and sore throat.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site exfoliation, Injection site rash, Injection site vesicles
Clinical narrative: Rash, blisters, flaking skin at injection site. Patient presented to Pharmacy 2 days after receiving immunization.
Age: 0.18
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Irritability, Respiratory arrest
Clinical narrative: Fussy and stopped breathing.
Age: 20.0
Sex: M
Vaccine: MENB
Symptoms: Myalgia, Pyrexia
Clinical narrative: High fever w/ muscle pain in the legs. MD contacted. TYLENOL was administered to decrease temperature.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Injection site discharge, Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling
Clinical narrative: Right upper arm, 24 hours later injection site with itch erythema and swelling, weeping and firm with itch.
Age: 1.51
Sex: F
Vaccine: MENB
Symptoms: Wrong drug administered
Clinical narrative: Pt was given the wrong vaccine.
Age: 13.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: (L) arm with softball size redness induration hot painful to touch.
Age: 58.0
Sex: F
Vaccine: PNC13
Symptoms: Rash pruritic, Skin warm, Urticaria
Clinical narrative: Symptoms: Hives, rash pruritus located on arms, in the inguinal areas and left side of face. Patient noticed warm spot on arm 7/12/16 at 6:00AM when she woke up. Hives started at 10AM while picking blueberries. By the end of the day 7/12/16 Hives had shown up in inguinal areas and left side of face. Patient took BENADRYL at home. Patient was seen back in office on 7/15/16. Patient was given Cephalexin 500mg, 4 times daily 7 days, Claritin 10 mg, once daily 10 days, Prednisone 20mg, twice daily for 5 days.
Age: 70.0
Sex: M
Vaccine: PNC13
Symptoms: Myalgia, X-ray limb normal
Clinical narrative: Pt reported muscle pain in (L) arm that developed after vaccine administration 3/1/16. Pain has persisted per report at last visit 6/21/16.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Fatigue, Pruritus, Skin warm
Clinical narrative: Admin PREVNAR 13 vaccine on 07/13/16 - (L) deltoid. Pt called 7/19 with c/o hot red mark 5" x 3" - itchy came in for eval same day - As above with c/o fatigue a day after injection - Advised ZYRTEC and to monitor.
Age: 11.0
Sex: M
Vaccine: HEPA
Symptoms: Asthenia, Fatigue, Muscle twitching, Tension
Clinical narrative: Patient's arms and torso tensed up within 20 seconds of injection, uncontrolled twitching for approximately 15 seconds. During this time he did not respond to his name. Once twitching stopped, pt. complained of fatigue and weakness.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Inflammation
Clinical narrative: Redness and inflammation resulting in Rx for Prednisone. Occurred over three days.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Local reaction
Clinical narrative: Red/erythema, local reaction only.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Dysphagia, Erythema, Inflammation, Nausea, Pain
Clinical narrative: Red, inflamed, soreness, swallowing, nausea for 5 days.
Age: 0.35
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Erythema, Urticaria
Clinical narrative: Received vaccine 7/18/16 - small amount of local redness noted after vaccines - thought to be due to band aids. They were removed. 3 days later, pt developed large hive type reaction to entire (R) thigh. No SOB noted. On day #4, reaction has improved and looks more  like dermatitis.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site reaction
Clinical narrative: Local reaction (L) del approx 3 mins after admin. Pt monitored x 15 mins. Provider instructed mom to give 25mg BENADRYL at home. ER warnings given.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site bruising, Injection site erythema, Injection site swelling, Injection site warmth, Tenderness
Clinical narrative: Day after vaccination given, (R) arm tender to touch only. On the morning of 7-16-16 (R) arm around injection site swollen, warm to touch reddened at 2 inches around injection site and some bruising. Redness and warmth continued. Seen by internist (friend) on 7/16/16. KEFLEX x 10d prescribed slowly resolving. Hematoma also around site.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Culture throat negative, Decreased appetite, Irritability, Pharyngitis, Polymerase chain reaction
Clinical narrative: 7/13 Presented w/ 2 day h/o fever Tmax 104.2F, fussiness, rash, decreased appetite. Multiple contacts at daycare w/ similar sxs. 7/15 Cont'd fever, worsening rash (sever, diffuse, maculopapular). Pharyngitis and exudates on exam Pt started on Amoxil.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Pyrexia, Rash, Rash maculo-papular, Respiratory viral panel, Streptococcus test positive
Clinical narrative: 7/13 Presented w/ 2 day h/o fever Tmax 104.2F, fussiness, rash, decreased appetite. Multiple contacts at daycare w/ similar sxs. 7/15 Cont'd fever, worsening rash (sever, diffuse, maculopapular). Pharyngitis and exudates on exam Pt started on Amoxil.
Age: 60.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Erythema, Hypoaesthesia, Urticaria
Clinical narrative: Patient had initial redness/numbness after receiving and started subsiding, then 6 days later woke up with hives on back of arm travelling up neck.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: 2:00pm right upper arm edema and reddened from shoulder to elbow on outer arm, 7/7/16. 7/8/16 MD appointment, prescription given for "steroid liquid" for three days. 7/9/16 symptoms subsided during afternoon, pm.
Age: 1.04
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: Administered MMR on 7/06/2016. Two days later developed a mild rash and low grade fever. Recovered 2-3 days later. Taken to clinic for treatment.
Age: 5.0
Sex: M
Vaccine: DTAP, VARCEL
Symptoms: Pyrexia, Rash erythematous, Tonsillar hypertrophy
Clinical narrative: Fever, red non raised rash, swollen tonsils. Fever started 7/27/16 and ended 7/28/16. Red rash and swollen tonsils started 7/29/16.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: (R) arm swelling and redness.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Asthenia, Bed rest, Fatigue, Headache, Muscular weakness
Clinical narrative: (1) First one fever x 2 days 103. Body aches, fatigue. (2) 2nd; within one hour moderate fatigue, pale, weak, leg weakness, very sleepy, headache, nausea x 24 hours (bed rest).
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Nausea, Pain, Pallor, Pyrexia, Somnolence
Clinical narrative: (1) First one fever x 2 days 103. Body aches, fatigue. (2) 2nd; within one hour moderate fatigue, pale, weak, leg weakness, very sleepy, headache, nausea x 24 hours (bed rest).
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Blood pressure increased, Chest discomfort, Dyspnoea, Fatigue, Headache
Clinical narrative: Tongue itchy 1st day. Chest tightness and throat tightness x3days - needed inhaler x3days. Had headache x3 days constantly - still having increase headaches 8 days later, but not constant. Resting heart rate elevated 8 days so far 104 + BPM. Increased blood pressure. Feel tired and more easily short of breath. Increased sweating with light-tasks x 8days. Not yet recovered about 8days but hopefully will.
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Heart rate increased, Pruritus, Throat tightness
Clinical narrative: Tongue itchy 1st day. Chest tightness and throat tightness x3days - needed inhaler x3days. Had headache x3 days constantly - still having increase headaches 8 days later, but not constant. Resting heart rate elevated 8 days so far 104 + BPM. Increased blood pressure. Feel tired and more easily short of breath. Increased sweating with light-tasks x 8days. Not yet recovered about 8days but hopefully will.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site mass, Injection site pain, Injection site warmth
Clinical narrative: Large red lump at injection site. Very hot to touch. Better but still there after 4 days. Very sore elbow near injection site. Off-and-on headaches and stiff neck.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Musculoskeletal stiffness
Clinical narrative: Large red lump at injection site. Very hot to touch. Better but still there after 4 days. Very sore elbow near injection site. Off-and-on headaches and stiff neck.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Dizziness, Feeling abnormal, Hypoaesthesia
Clinical narrative: Pt waited in store about an hour after shot given, said experienced weakness, dizziness, and numbness in left arm; was feeling better at about an hour post shot. Stated has poor circulation normally in extremities and this could be due to hunger. Also felt foggy.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Patient reported warm, painful red area at site of ZOSTAVAX injection on Sunday, 7-24-16. She saw doctor on Monday 7-25-16 and was destroyed with cellulitis and prescribed antibiotic.
Age: 1.0
Sex: M
Vaccine: HEP, HEPA, MMR, VARCEL
Symptoms: Urticaria
Clinical narrative: Hive below injection site shortly after injection.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Erythema, Full blood count, Rash, Rash macular
Clinical narrative: 30 min after vaccine, pt developed rash on trunk to ext. macular, erythema.
Age: 9.0
Sex: F
Vaccine: HEP, IPV, MMR, TDAP, VARCEL
Symptoms: Dyskinesia, Loss of consciousness, Syncope
Clinical narrative: After child received Tdap, IPV, Varicella, Hepatitis B and MMR she fainted in chair, Jerky movements noted for 10 seconds. Transitioned to floor until conscious and stable then transported to cot. Lift clinic 2 hrs later with parents.
Age: 20.0
Sex: M
Vaccine: MENB
Symptoms: Cough, Fall, Head injury
Clinical narrative: At around 1 am 07/29/16 patient awakened with a cough went downstairs in into his living room fell on the floor rolling around coughing uncontrollably. He rolled into a table on top hit the side of his head. He then went back upstairs to bed and slept the rest of the night. The episode lasted a "few seconds" according to him.
Age: 0.55
Sex: M
Vaccine: DTAPIPVHIB, HEPA, PNC13, RV5
Symptoms: Wrong drug administered
Clinical narrative: Hep A was given, but Hep B was ordered.
Age: 0.36
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Incorrect product formulation administered
Clinical narrative: Green PENTACEL vial (HIB) was mixed with normal saline and administered without the blue vial (DTAP) (IPV). Contacted manufacturer and a complete PENTACEL needs to be administered.
Age: 17.0
Sex: U
Vaccine: MENB, MNQ
Symptoms: Urticaria
Clinical narrative: 1.5 hours after leaving office, started breaking out in hives all over.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Erythema, Peripheral swelling
Clinical narrative: (R) arm swelling and redness.
Age: 12.0
Sex: U
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report concerning a 12 years old patient of an unknown gender was received from a nurse. The patient's concurrent conditions and medical history were not reported. On 22-JUL-2016, the patient was inadvertently vaccinated with a dose of 1 ml of VAQTA lot # L031196, expiration date 05-FEB-2017, (strength and route were not provided)(accidental overdose). There were no concomitant medications and adverse events reported. No product quality complain was involved. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Allodynia, Alopecia, Anxiety, Asthenia
Clinical narrative: This spontaneous report as received from a consumer through a webpage, refers to a 17 year old (also reported as 15 year old) female patient. The reporter described the patient to be healthy, active and academically gifted. On September 2012, the patient received dose 1 of GARDASIL. In February 2013, the patient received dose 2 of GARDASIL. On an unknown date in 2013, approximately a week after the patient received dose 2 of GARDASIL, she developed cold symptoms and a barking cough. The patient went on to develop repeated lung spasms. Reporter did not think these events were related to the vaccine. In July 2013, the patient was vaccinated with the third dose of GARDASIL. No concomitant medication was reported. On an unknown date in 2013, after the patient received dose 3 of GARDASIL, she experienced dizziness, loss of balance, weakness, anxiety, ear pain, abdominal pain and nausea. Reporter did not associate patient's new symptoms with the vaccine. On an unknown date in December 2014, the patient was diagnosed with a simple sinus infection and was prescribed a "z-pack" which she has had many times before with no problems. Approximately 15 minutes after administration of the first dose of the "z-pack", reporter was frantically working to keep the patient alive until the ambulance arrived. Patient was diagnosed with severe unexplained hypokalemia (life threatening low potassium) and a cardiac condition called electrocardiogram QT prolonged. Patient was treated with intravenous (IV) potassium and magnesium, then released. On an unknown date, the patient was diagnosed with familial periodic paralysis with outlying symptoms of Hashimoto's, autoimmune disorder, hair loss, nerve damage; as per an Electromyography (EMG) test, weakness, tremors, exercise intolerance, heat/cold intolerance, air hunger, chest pain, abdominal pain, nausea and vomiting, brain fog, allodynia, nystagmus and non-epileptic seizures. The outcomes of all the events were unknown. The reporter stated that GARDASIL had devastatingly injured the patient and hence causality assessment was considered related. The reporter considered hypokalemia to be life-threatening. Upon internal review, hypokalemia, prolonged QT interval, Hashimoto's, autoimmune disorder and non epileptic seizure were considered to be medically significant. This is one of the two reports from the same source (linked to MARRS # 1607USA012465). Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Autoimmune thyroiditis, Balance disorder, Blood potassium decreased, Chest pain, Cough
Clinical narrative: This spontaneous report as received from a consumer through a webpage, refers to a 17 year old (also reported as 15 year old) female patient. The reporter described the patient to be healthy, active and academically gifted. On September 2012, the patient received dose 1 of GARDASIL. In February 2013, the patient received dose 2 of GARDASIL. On an unknown date in 2013, approximately a week after the patient received dose 2 of GARDASIL, she developed cold symptoms and a barking cough. The patient went on to develop repeated lung spasms. Reporter did not think these events were related to the vaccine. In July 2013, the patient was vaccinated with the third dose of GARDASIL. No concomitant medication was reported. On an unknown date in 2013, after the patient received dose 3 of GARDASIL, she experienced dizziness, loss of balance, weakness, anxiety, ear pain, abdominal pain and nausea. Reporter did not associate patient's new symptoms with the vaccine. On an unknown date in December 2014, the patient was diagnosed with a simple sinus infection and was prescribed a "z-pack" which she has had many times before with no problems. Approximately 15 minutes after administration of the first dose of the "z-pack", reporter was frantically working to keep the patient alive until the ambulance arrived. Patient was diagnosed with severe unexplained hypokalemia (life threatening low potassium) and a cardiac condition called electrocardiogram QT prolonged. Patient was treated with intravenous (IV) potassium and magnesium, then released. On an unknown date, the patient was diagnosed with familial periodic paralysis with outlying symptoms of Hashimoto's, autoimmune disorder, hair loss, nerve damage; as per an Electromyography (EMG) test, weakness, tremors, exercise intolerance, heat/cold intolerance, air hunger, chest pain, abdominal pain, nausea and vomiting, brain fog, allodynia, nystagmus and non-epileptic seizures. The outcomes of all the events were unknown. The reporter stated that GARDASIL had devastatingly injured the patient and hence causality assessment was considered related. The reporter considered hypokalemia to be life-threatening. Upon internal review, hypokalemia, prolonged QT interval, Hashimoto's, autoimmune disorder and non epileptic seizure were considered to be medically significant. This is one of the two reports from the same source (linked to MARRS # 1607USA012465). Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Dyspnoea, Ear pain, Electrocardiogram QT prolonged, Electrolyte substitution therapy
Clinical narrative: This spontaneous report as received from a consumer through a webpage, refers to a 17 year old (also reported as 15 year old) female patient. The reporter described the patient to be healthy, active and academically gifted. On September 2012, the patient received dose 1 of GARDASIL. In February 2013, the patient received dose 2 of GARDASIL. On an unknown date in 2013, approximately a week after the patient received dose 2 of GARDASIL, she developed cold symptoms and a barking cough. The patient went on to develop repeated lung spasms. Reporter did not think these events were related to the vaccine. In July 2013, the patient was vaccinated with the third dose of GARDASIL. No concomitant medication was reported. On an unknown date in 2013, after the patient received dose 3 of GARDASIL, she experienced dizziness, loss of balance, weakness, anxiety, ear pain, abdominal pain and nausea. Reporter did not associate patient's new symptoms with the vaccine. On an unknown date in December 2014, the patient was diagnosed with a simple sinus infection and was prescribed a "z-pack" which she has had many times before with no problems. Approximately 15 minutes after administration of the first dose of the "z-pack", reporter was frantically working to keep the patient alive until the ambulance arrived. Patient was diagnosed with severe unexplained hypokalemia (life threatening low potassium) and a cardiac condition called electrocardiogram QT prolonged. Patient was treated with intravenous (IV) potassium and magnesium, then released. On an unknown date, the patient was diagnosed with familial periodic paralysis with outlying symptoms of Hashimoto's, autoimmune disorder, hair loss, nerve damage; as per an Electromyography (EMG) test, weakness, tremors, exercise intolerance, heat/cold intolerance, air hunger, chest pain, abdominal pain, nausea and vomiting, brain fog, allodynia, nystagmus and non-epileptic seizures. The outcomes of all the events were unknown. The reporter stated that GARDASIL had devastatingly injured the patient and hence causality assessment was considered related. The reporter considered hypokalemia to be life-threatening. Upon internal review, hypokalemia, prolonged QT interval, Hashimoto's, autoimmune disorder and non epileptic seizure were considered to be medically significant. This is one of the two reports from the same source (linked to MARRS # 1607USA012465). Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Electromyogram abnormal, Exercise tolerance decreased, Familial periodic paralysis, Hypokalaemia, Mineral supplementation
Clinical narrative: This spontaneous report as received from a consumer through a webpage, refers to a 17 year old (also reported as 15 year old) female patient. The reporter described the patient to be healthy, active and academically gifted. On September 2012, the patient received dose 1 of GARDASIL. In February 2013, the patient received dose 2 of GARDASIL. On an unknown date in 2013, approximately a week after the patient received dose 2 of GARDASIL, she developed cold symptoms and a barking cough. The patient went on to develop repeated lung spasms. Reporter did not think these events were related to the vaccine. In July 2013, the patient was vaccinated with the third dose of GARDASIL. No concomitant medication was reported. On an unknown date in 2013, after the patient received dose 3 of GARDASIL, she experienced dizziness, loss of balance, weakness, anxiety, ear pain, abdominal pain and nausea. Reporter did not associate patient's new symptoms with the vaccine. On an unknown date in December 2014, the patient was diagnosed with a simple sinus infection and was prescribed a "z-pack" which she has had many times before with no problems. Approximately 15 minutes after administration of the first dose of the "z-pack", reporter was frantically working to keep the patient alive until the ambulance arrived. Patient was diagnosed with severe unexplained hypokalemia (life threatening low potassium) and a cardiac condition called electrocardiogram QT prolonged. Patient was treated with intravenous (IV) potassium and magnesium, then released. On an unknown date, the patient was diagnosed with familial periodic paralysis with outlying symptoms of Hashimoto's, autoimmune disorder, hair loss, nerve damage; as per an Electromyography (EMG) test, weakness, tremors, exercise intolerance, heat/cold intolerance, air hunger, chest pain, abdominal pain, nausea and vomiting, brain fog, allodynia, nystagmus and non-epileptic seizures. The outcomes of all the events were unknown. The reporter stated that GARDASIL had devastatingly injured the patient and hence causality assessment was considered related. The reporter considered hypokalemia to be life-threatening. Upon internal review, hypokalemia, prolonged QT interval, Hashimoto's, autoimmune disorder and non epileptic seizure were considered to be medically significant. This is one of the two reports from the same source (linked to MARRS # 1607USA012465). Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Muscle spasms, Nasopharyngitis, Nausea, Nerve injury, Nystagmus
Clinical narrative: This spontaneous report as received from a consumer through a webpage, refers to a 17 year old (also reported as 15 year old) female patient. The reporter described the patient to be healthy, active and academically gifted. On September 2012, the patient received dose 1 of GARDASIL. In February 2013, the patient received dose 2 of GARDASIL. On an unknown date in 2013, approximately a week after the patient received dose 2 of GARDASIL, she developed cold symptoms and a barking cough. The patient went on to develop repeated lung spasms. Reporter did not think these events were related to the vaccine. In July 2013, the patient was vaccinated with the third dose of GARDASIL. No concomitant medication was reported. On an unknown date in 2013, after the patient received dose 3 of GARDASIL, she experienced dizziness, loss of balance, weakness, anxiety, ear pain, abdominal pain and nausea. Reporter did not associate patient's new symptoms with the vaccine. On an unknown date in December 2014, the patient was diagnosed with a simple sinus infection and was prescribed a "z-pack" which she has had many times before with no problems. Approximately 15 minutes after administration of the first dose of the "z-pack", reporter was frantically working to keep the patient alive until the ambulance arrived. Patient was diagnosed with severe unexplained hypokalemia (life threatening low potassium) and a cardiac condition called electrocardiogram QT prolonged. Patient was treated with intravenous (IV) potassium and magnesium, then released. On an unknown date, the patient was diagnosed with familial periodic paralysis with outlying symptoms of Hashimoto's, autoimmune disorder, hair loss, nerve damage; as per an Electromyography (EMG) test, weakness, tremors, exercise intolerance, heat/cold intolerance, air hunger, chest pain, abdominal pain, nausea and vomiting, brain fog, allodynia, nystagmus and non-epileptic seizures. The outcomes of all the events were unknown. The reporter stated that GARDASIL had devastatingly injured the patient and hence causality assessment was considered related. The reporter considered hypokalemia to be life-threatening. Upon internal review, hypokalemia, prolonged QT interval, Hashimoto's, autoimmune disorder and non epileptic seizure were considered to be medically significant. This is one of the two reports from the same source (linked to MARRS # 1607USA012465). Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Seizure, Sinusitis, Temperature intolerance, Tremor, Vomiting
Clinical narrative: This spontaneous report as received from a consumer through a webpage, refers to a 17 year old (also reported as 15 year old) female patient. The reporter described the patient to be healthy, active and academically gifted. On September 2012, the patient received dose 1 of GARDASIL. In February 2013, the patient received dose 2 of GARDASIL. On an unknown date in 2013, approximately a week after the patient received dose 2 of GARDASIL, she developed cold symptoms and a barking cough. The patient went on to develop repeated lung spasms. Reporter did not think these events were related to the vaccine. In July 2013, the patient was vaccinated with the third dose of GARDASIL. No concomitant medication was reported. On an unknown date in 2013, after the patient received dose 3 of GARDASIL, she experienced dizziness, loss of balance, weakness, anxiety, ear pain, abdominal pain and nausea. Reporter did not associate patient's new symptoms with the vaccine. On an unknown date in December 2014, the patient was diagnosed with a simple sinus infection and was prescribed a "z-pack" which she has had many times before with no problems. Approximately 15 minutes after administration of the first dose of the "z-pack", reporter was frantically working to keep the patient alive until the ambulance arrived. Patient was diagnosed with severe unexplained hypokalemia (life threatening low potassium) and a cardiac condition called electrocardiogram QT prolonged. Patient was treated with intravenous (IV) potassium and magnesium, then released. On an unknown date, the patient was diagnosed with familial periodic paralysis with outlying symptoms of Hashimoto's, autoimmune disorder, hair loss, nerve damage; as per an Electromyography (EMG) test, weakness, tremors, exercise intolerance, heat/cold intolerance, air hunger, chest pain, abdominal pain, nausea and vomiting, brain fog, allodynia, nystagmus and non-epileptic seizures. The outcomes of all the events were unknown. The reporter stated that GARDASIL had devastatingly injured the patient and hence causality assessment was considered related. The reporter considered hypokalemia to be life-threatening. Upon internal review, hypokalemia, prolonged QT interval, Hashimoto's, autoimmune disorder and non epileptic seizure were considered to be medically significant. This is one of the two reports from the same source (linked to MARRS # 1607USA012465). Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: HPVX
Symptoms: Chills, Dizziness, Headache, Injection site erythema, Injection site swelling
Clinical narrative: Red raised injection site, Fever 102.5, chills, body aches, dizziness, nausea, headache thats throbbing lasting 1 week and still has.
Age: 12.0
Sex: M
Vaccine: HPVX
Symptoms: Nausea, Pain, Pyrexia
Clinical narrative: Red raised injection site, Fever 102.5, chills, body aches, dizziness, nausea, headache thats throbbing lasting 1 week and still has.
Age: 0.18
Sex: F
Vaccine: 6VAX-F
Symptoms: Constipation, Crying, Pain
Clinical narrative: After the 2 month vaccinations my child became constipated. We have had this problem for over 3 weeks. She cries out in pain. Her bowel movements require assistance with laxatives and suppositories. We thought it was related to the formula but that has changed and she is still with the problem.
Age: 17.0
Sex: M
Vaccine: MENB, MNQ, MEN, MENB, MENB, MNQ
Symptoms: CSF test, Full blood count normal, Headache, Laboratory test normal, Liver function test normal
Clinical narrative: Initially had fever (temp 103) and persistent headache x9 days (hospital admission due to intractable severe headaches).
Age: 17.0
Sex: M
Vaccine: MENB, MNQ, MEN, MENB, MENB, MNQ
Symptoms: Lumbar puncture, Nuclear magnetic resonance imaging normal, Pyrexia, Urine analysis normal, Venogram normal
Clinical narrative: Initially had fever (temp 103) and persistent headache x9 days (hospital admission due to intractable severe headaches).
Age: 17.0
Sex: M
Vaccine: MENB, MNQ, MEN, MENB, MENB, MNQ
Symptoms: Angiogram, Blood test, Headache, Lumbar puncture, Nuclear magnetic resonance imaging
Clinical narrative: Initially had fever (temp 103) and persistent headache x9 days (hospital admission due to intractable severe headaches).
Age: 17.0
Sex: M
Vaccine: MENB, MNQ, MEN, MENB, MENB, MNQ
Symptoms: Pyrexia, Venogram
Clinical narrative: Initially had fever (temp 103) and persistent headache x9 days (hospital admission due to intractable severe headaches).
Age: 17.0
Sex: M
Vaccine: MENB, MNQ, MEN, MENB, MENB, MNQ
Symptoms: Migraine, Pyrexia
Clinical narrative: Initially had fever (temp 103) and persistent headache x9 days (hospital admission due to intractable severe headaches).
Age: 66.0
Sex: M
Vaccine: PNC13, VARZOS
Symptoms: Loss of consciousness, Presyncope
Clinical narrative: VASOVAGAL SYMPTOMS AFTER VACCINE ADMINISTRATION. PATIENT PASSED OUT WHILE SITTING DOWN A COUPLE OF MINUTES AFTER VACCINE ABOUT 30 SECONDS LATER HE CAME TO. BLOOD PRESSURE WAS 90/50 mmHG. PATIENT LAID DOWN FOR ABOUT THIRTY MINUTES AND SYMPTOMS RESOLVED.
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Hypoaesthesia, Nausea, Vertigo, Vomiting
Clinical narrative: Numbness in injection arm and fingers, vertigo, nausea and vomiting.
Age: 1.24
Sex: M
Vaccine: MMR
Symptoms: Cough, Pyrexia, Rash, Rash erythematous, Rhinorrhoea
Clinical narrative: Fever below 102F, runny nose and cough, red lacy rash over stomach, side and back.
Age: 11.0
Sex: M
Vaccine: HPV4, MEN, TDAP
Symptoms: Asthenia, Chills, Hypersomnia, Musculoskeletal stiffness, Myalgia
Clinical narrative: My child felt weak, was teary, and felt stiff and achy.  He slept most of the day.  He had severe muscle pain most of the day as well.  Chills and low fever.  He looked a bit better by the following morning and was well by 7/29/16.
Age: 11.0
Sex: M
Vaccine: HPV4, MEN, TDAP
Symptoms: Pain, Pyrexia, Tearfulness
Clinical narrative: My child felt weak, was teary, and felt stiff and achy.  He slept most of the day.  He had severe muscle pain most of the day as well.  Chills and low fever.  He looked a bit better by the following morning and was well by 7/29/16.
Age: 48.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient had swelling, redness, and heat around injection site.  Three days after injection- it kept getting bigger/worse.  She went to urgent care and was diagnosed with Cellulitis.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Redness, swelling, and itching at injection site.
Age: 21.0
Sex: F
Vaccine: PPV
Symptoms: Abdominal discomfort, Pruritus generalised, Urticaria
Clinical narrative: Patient received a pneumonia vaccination and several hours later after her lunch reported upset stomach, general itching with some welts (no respiratory issues).  She stated she didn't know if the reaction was to the immunization or something she ate at lunch time.  Patient took benadryl and applied cold compresses and reported she was improving and doing better.  Pharmacist instructed patient to go to the emergency room if her symptoms should return.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Rash to (L) forehead just lateral to eye. Started 4 days after vaccine given. Due to location she was referred to ER for further evaluation by on call Ophthalmologist.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from medical assistant refers to a patient of unknown age and gender. The patient's pertinent medical history, current conditions and concomitant medications were not reported. No previous drug reactions or allergies were reported. On 26-JUL-2016 the patient was vaccinated with improperly stored VARIVAX (dosing details were not reported) (lot # 1035124, expiry date 14-SEP-2107) (incorrect product storage). No adverse effects were reported. There was no product quality complaint involved. This is one of the two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient's pertinent medical history, current conditions and concomitant medications were not reported. No previous drug reactions or allergies were reported. On 19-JUL-2016 the patient was vaccinated with improperly stored PNEUMOVAX 23 (dosing details were not reported) (lot # L022262 expiry date 05-NOV-2016) which was stored at a temperature of 56.3 F for a time frame of 9 hours. There were no previous temperature excursions reported. It was reported as the call was made because of data logger (therapy type: digital data logger). No adverse effects were reported. There was no product quality complaint involved. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On an unknown date in 2016 (reported as "between 01-MAR-2016 and 14-JUL-2016"), the patient was inadvertently vaccinated with a dose of improperly stored M-M-R II (lot# L037356, expiration date 28-SEP-2017, therapy type rHA, route not reported). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Adverse event, Injection site hypoaesthesia, Injection site pain
Clinical narrative: This spontaneous report was received from patient's mother regarding her son a 12 year old male patient. Patient had none pertinent medical history and drug allergies or reaction. On 20-JUN-2016, the patient was vaccinated with GARDASIL 9 lot # M004116/expiration date- 12-OCT-2017, dose 3 in the left arm. On an unspecified date the patient was vaccinated with GARDASIL 9, dose 1 and 2. Concomitant medication reported was CLARITIN. On 29-JUN-2016, 9 days later the therapy was given the patient experienced numbness and pain at the injection site. It was also reported during the call that the patient experienced unspecified side effects after receiving first and second dose in the series. Treatment was given for the adverse events. No laboratory diagnostics or tests were performed. Patient spoke to the physician to seek medical attention. Therapy with GARDASIL 9 was not discontinued. The outcome of numbness and pain at the injection site was reported as not resolved. The outcome of unspecified side effects was unknown. Causality was unknown. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse referring to multiple patients of unknown ages and genders. The patients' medical histories, concurrent conditions and concomitant therapies were not reported. On unknown dates in 2016 (reported as "between 01-MAR-2016 and 14-JUL-2016"), 3 doses of improperly stored LIQUID PEDVAXHIB (lot# L042835, expiration ate 19-AUG-2018, route not reported) were inadvertently administered to the patients. No adverse effect was reported. This is one of several reports received from same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse referring to multiple patients of unknown ages and genders. The patients' medical histories, concurrent conditions and concomitant therapies were not reported. On unknown dates in 2016 (reported as "between 01-MAR-2016 and 14-JUL-2016"), 2 doses of improperly stored GARDASIL 9 (lot# L048237, expiration date 08-MAY-2017, route not reported) were inadvertently administered to the patients. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse referring to multiple patients of unknown ages and genders. The patients' medical histories, concurrent conditions and concomitant therapies were not reported. On unknown dates in 2016 (reported as "between 01-MAR-2016 and 14-JUL-2016"), 4 doses of improperly stored ROTATEQ (oral, lot# L008997, expiration date 04-DEC-2016)) were inadvertently administered to the patients. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 62.0
Sex: M
Vaccine: TDAP
Symptoms: Cellulitis, Dizziness, Peripheral swelling, Pyrexia, Swollen tongue
Clinical narrative: Patient had delayed reaction after shot causing tongue swelling, swollen arm, fever, dizziness, and developed cellulitis.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from medical assistant refers to a patient of unknown age and gender. The patient's pertinent medical history, current conditions and concomitant medications were not reported. No previous drug reactions or allergies were reported. On 26-JUL-2016 the patient was vaccinated with improperly stored VARIVAX (dosing details were not reported) (lot # 1035124, expiry date 14-SEP-2017). No adverse effects were reported. There was no product quality complaint involved. This is one of the two reports received from the same reporter. Additional information has been requested.
Age: 56.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles outbreak, confirmed by physician.
Age: 56.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: Patient had outbreak of shingles at the mandible area on her face.
Age: 11.0
Sex: F
Vaccine: HPV9, MEN, TDAP
Symptoms: Abdominal pain upper, Anxiety, Cyanosis, Depression, Dizziness
Clinical narrative: Patient had a syncopal episode followed by tonic/clonic seizure like activity. This lasted between 3 and five minutes. When she came out of it, her body and face were white and lips were purple. She had no recollection of what had taken place. The next 36 hours she described significant stomach pain, extreme fatigue, dizziness, and anxiety/depression.
Age: 11.0
Sex: F
Vaccine: HPV9, MEN, TDAP
Symptoms: Fatigue, Pallor, Seizure like phenomena, Syncope, Tonic clonic movements
Clinical narrative: Patient had a syncopal episode followed by tonic/clonic seizure like activity. This lasted between 3 and five minutes. When she came out of it, her body and face were white and lips were purple. She had no recollection of what had taken place. The next 36 hours she described significant stomach pain, extreme fatigue, dizziness, and anxiety/depression.
Age: 1.0
Sex: M
Vaccine: MMR, PNC13
Symptoms: Body temperature increased, Rash, Rash erythematous, Vaccination complication
Clinical narrative: Tiny rash-like red dots appeared on torso and back in the morning. By 3pm, the rash had become larger, more visible and had spread to extremities. By the next morning, 7/27/16, the rash had intensified and spread to face.  Bumps become extremely red, raised and some clustered together (none blistered or oozed - just red and raised). Had consistent temperature above 100-degrees F for 24 hours. Temperature reached up to 101.9. Called Doctor everyday, and spoke with nurses. Finally, we were able to go to Dr. and he indicated this was worst reaction to MMR Vaccine he had seen in over a decade. Rash symptoms still present after 6 days.
Age: 84.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site bruising, Rash, Rash pruritic
Clinical narrative: TUESDAY 7/27 PATIENT RECEIVE IM SHOT OF PREVNAR. ON WEDNESDAY SHE NOTICED BLACK AND BLUE BRUISING NEAR INJECTION SITE. BY FRIDAY SHE DEVELOPED A RASH ON BOTH ARMS THAT WAS VERY ITCHY.
Age: 0.24
Sex: F
Vaccine: DTP, HEP, HIBV, IPV, PPV, RVX
Symptoms: Seizure like phenomena
Clinical narrative: Seizure-like activity.
Age: 76.0
Sex: F
Vaccine: PNC13, TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site warmth
Clinical narrative: Warm to touch; itchiness; mild hardness, pinkish skin color around the injection site that had spread about a size of a palm on the left arm.
Age: 32.0
Sex: F
Vaccine: MMR
Symptoms: Fatigue, Injection site bruising, Injection site pain, Pain, White blood cell count decreased
Clinical narrative: in the days following the injection, I had a bruise at the injection site and started having body aches and fatigue that worsened over the course of serveral days. I went to my PCP for my annual physical and my CBC blood work showed below normal WBC count. This is unusual as my WBC count had been fine a month and a half ago when I had minor foot surgery. Two weeks after the findings, I had another CBC done and it had gone back into the normal range. At four weeks post vaccination, I still have a bruise and soreness at the injection site.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site inflammation, Injection site pain
Clinical narrative: PT EXPERIENCED BRUISE INFLAMMATION AND PAIN AT SOURCE OF INJECTION AND DOWN THE ARM. POSSIBLE LEAK OF VACCINATION TO MUSCLE. LASTED SEVERAL DAYS. NO SIGN OR SYMPTOMS PERSISTED. THERE WERE NO VISIBLE SIGNS AND PATIENT SAID THE ARM DID NOT HURT ANYMORE. POSSIBLE. NO TREATMENT WAS DISCUSSED. AND PT WAS OK AND CLEAR ON 7/29/16.
Age: 76.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Patient reported swelling, redness, and itching locally around injection site. Instructed them to take BENADRYL 50 mg STAT then 25 mg every 4-6 hours.
Age: 17.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Confusional state, Dizziness, Fall, Feeling abnormal, Head injury
Clinical narrative: Patient felt dreamy while walking out of office and fell backward striking head on floor, no loss of consciousness or neurological symptoms or focal problems on exam, no neck pain, did not know where he was for about 5 seconds. Was dizzy. Had not eaten before vaccination all day. Was given water, cool compress to forehead, crackers and allowed to sit for 30 minutes. All symptoms resolved.
Age: 5.0
Sex: F
Vaccine: RAB
Symptoms: Decreased appetite, Injection site pain, Lethargy
Clinical narrative: Pain at injection site, lethargic, loss of appetite.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Rash
Clinical narrative: Information has been received from a pharmacist referring to a patient of unknown age. The pertinent medical history and concomitant therapy were not reported. On an unknown date, the patient was vaccinated with the first dose of ZOSTAVAX (lot # L046897, expiration date: 23-FEB-2017(dose and frequency unspecified). On an unknown date, the patient had a rash on an unspecified arm after receiving ZOSTAVAX and the patient also developed bruising at the injection site. The outcome of the events was unknown. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from an office manager referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant medication were not reported. On an unknown date in April 2012 the patient was vaccinated with the first dose of GARDASIL (dose, route, lot # and expiration date were unknown). It was reported that the second dose of GARDASIL (dose, route, lot # and expiration date were unknown) was given in November 2012 and the third dose (dose, route, lot # and expiration date unknown) was given on 20-AUG-2014. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to multiple unspecified patients of unknown age and gender. Information regarding concomitant medication, medical history and drug reaction/allergies were not reported. On unknown dates, the patients were vaccinated with doses of improperly stored RECOMBIVAX (lot # M010212 with expiration date 21-JAN-2019; dose and route were not reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to multiple unspecified patients of unknown age and gender. Information regarding concomitant medication, medical history and drug reactions/allergies were not reported. On unknown dates, the patients were vaccinated with doses of improperly stored GARDASIL 9 (lot # M005714 with expiration date 03-OCT-2017; dose and route were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to multiple unspecified patients of unknown age and gender. Information regarding concomitant medication, medical history and drug reactions/allergies were not reported. On unknown dates, the patients were vaccinated with doses of improperly stored M-M-R II (lot # L036851 with expiration date 23-SEP-2017 and lot # 037356 with expiration date 28-SEP-2017; dose and route were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to multiple unspecified patients of unknown age and gender. Information regarding concomitant medication, medical history and drug reactions/allergies were not reported. On unknown dates, the patients were vaccinated with doses of improperly stored PNEUMOVAX 23 (lot # L019836 with expiration date 24-MAR-2017 and lot # 048265 with expiration date 10-JUN-2017; dose and route were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.