chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 11.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Nurse administered high dose seasonal flu (65 and older) to  a healthy 11 year female. Nurse reached into the refrigerator bin  to use VFC flu for client  and instead took a High Dose Flu instead of VFC dose. 4 doses of Hi Dose had been left lose in bin. Nurse failed to read label or note lot number prior to administering flu shot. Label colors on  VFC Flulaval single dose and Sanofi single Hi Dose are similar in color(both blue).  Child reports no adverse  side effects as of 72 hours post vaccination.  Nurse was written up for not checking labels or lot numbers prior to administering and another staff member who left High Dose flu unlabel also written up. Immediate report occured by nursing supervisor to Medical director and parents were notified by nurse.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Myalgia, Nausea, Pyrexia
Clinical narrative: Chills, low-grade fever, muscle aches all over, weakness, nausea which started approximately 9 to 10 hours after receiving the vaccination. The symptoms continued through the night and began resolving the next day.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Patient called on 2/3/2020 reporting the reaction to Shingrix. She had redness, throbbing, and swelling circumference of a 'softball'. She said she discovered the reaction late in the evening (around 8 pm on 2/1/2020).
Age: 65.0
Sex: M
Vaccine: FLU4
Symptoms: Musculoskeletal disorder, Pain in extremity
Clinical narrative: Patient is complaining of a sore arm and limited ability to use arm since vaccine administration
Age: 10.0
Sex: F
Vaccine: FLUN4
Symptoms: Ear pain, Influenza B virus test positive, Malaise, Oropharyngeal pain, Pyrexia
Clinical narrative: Child seen at local health facility for earache but relatively well on 11/27/19, and again had earache along with sore throat on 1/25/20,  This time much more ill, spent two days in bed with fever. Home sick for a week.
Age: 1.25
Sex: M
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: Expired vaccine.  Expired on 01/30/2020
Age: 24.0
Sex: F
Vaccine: FLU4
Symptoms: Discomfort, Pain, Peripheral swelling
Clinical narrative: swelling of the entire arm, hand and fingers;  pain and discomfort
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Back pain, Dyspnoea, Feeling abnormal, Headache
Clinical narrative: First day I became very shaky and feeling off not right. Second day I woke up to the worst ever headache, neck pain , upper back and lower back pain, left wrist and ankles in pain, and i became extremely drowsy not able to stay awake. Third day, Lower back pain was bad, and ankle swelling some and painful. Fourth day painful in the kidney or lower lung made me feel like i could not breathe when breathing in. I have right wrist pain. This so far as it is still going on. Sorry the part about the breathing happened on the second and third day.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Joint swelling, Neck pain, Nervousness, Pulmonary pain, Renal pain
Clinical narrative: First day I became very shaky and feeling off not right. Second day I woke up to the worst ever headache, neck pain , upper back and lower back pain, left wrist and ankles in pain, and i became extremely drowsy not able to stay awake. Third day, Lower back pain was bad, and ankle swelling some and painful. Fourth day painful in the kidney or lower lung made me feel like i could not breathe when breathing in. I have right wrist pain. This so far as it is still going on. Sorry the part about the breathing happened on the second and third day.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Somnolence
Clinical narrative: First day I became very shaky and feeling off not right. Second day I woke up to the worst ever headache, neck pain , upper back and lower back pain, left wrist and ankles in pain, and i became extremely drowsy not able to stay awake. Third day, Lower back pain was bad, and ankle swelling some and painful. Fourth day painful in the kidney or lower lung made me feel like i could not breathe when breathing in. I have right wrist pain. This so far as it is still going on. Sorry the part about the breathing happened on the second and third day.
Age: 2.0
Sex: M
Vaccine: HIBV, PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: REDNESS AND TENDERNESS AS WELL AS LOCAL SWELLING TO RiGHT THiGH (HiS VACCiNATION SITE) 2-12 HOURS AFTER VACCiNATiON. TREATMENT: MOIST COMPRESSES
Age: 36.0
Sex: F
Vaccine: FLUC4
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Patient complains of pain and decreased movement to left arm since injection. Patient has been seen by Primary Care Physician & Orthopedist.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: Grandma called 2 days after the vaccines were given and reported: Injection site the evening after the vaccines were given had become swollen to the size of a softball and it "welted up" and became very red, hot and painful.  There was no improvement the following day. The day that she called (1-9-20)  she stated that there was a little less redness, same amount of swelling, hot to touch and painful.  No fever was reported. An appointment was schedule for that evening in the office. Patient was put on antibiotics, benadryl and was told to do cold compresses to the area. Was instructed to call back if not improving over the next 24 hours or if appeared to get worse. Grandma did not call back.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Urticaria
Clinical narrative: Grandma called 2 days after the vaccines were given and reported: Injection site the evening after the vaccines were given had become swollen to the size of a softball and it "welted up" and became very red, hot and painful.  There was no improvement the following day. The day that she called (1-9-20)  she stated that there was a little less redness, same amount of swelling, hot to touch and painful.  No fever was reported. An appointment was schedule for that evening in the office. Patient was put on antibiotics, benadryl and was told to do cold compresses to the area. Was instructed to call back if not improving over the next 24 hours or if appeared to get worse. Grandma did not call back.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Inflammatory marker test, Myalgia
Clinical narrative: initially axial muscle pain and weakness, profound weakness, I initially suspected PMR but normal labs and inflammatory markers obtained, referred to neurology who agreed may be related to immunization,  responded best to prednisone 40-60 mg over several weeks
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Blood glucose normal, Dizziness, Fall, Hypotension, Syncope
Clinical narrative: Patient was standing about 10 minutes after the vaccine was given and had dizziness with brief syncope.  His vitals were assess and he was noted to have a low blood pressure that improved quickly.  He was alert and oriented after the syncope.  He was transported via EMS to the emergency room for monitoring and evaluation due to concern that he may have hit his head when he fell.  Patient also reported that he had not had anything to eat or drink the day of the vaccines.  His glucose was normal.
Age: 10.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Patient woke up the morning after vaccination with redness around the injection site and complaining that it was itchy.  The redness continued to progress over that day and the next to the point that it was 6-8 inches in width and hot to the touch.
Age: 24.0
Sex: M
Vaccine: PPV
Symptoms: Haematoma infection, Injection site erythema, Pyrexia
Clinical narrative: fever, redness at site. visited urgent care, diagnosed with infected hematoma and given antibiotic
Age: 87.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Rash, Swelling
Clinical narrative: Patient experienced welling and redness over the first 3 days after administration of 2nd Shingrix vaccine. Patient experienced a rash lasting around 7 days. Patient was informed of the potential adverse effects and to report them to our pharmacy if they occur. Patient does not have any residual effects.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling hot, Pruritus, Rash, Rash macular
Clinical narrative: Rash on neck, torso, armpits, back. spots at first than spots merged to make a blotching. Got hot and itchy. used benadryl for itch and cortisone. Itched more at night and lasted for about 6 days.
Age: 38.0
Sex: F
Vaccine: FLU4, MNQ, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: complaints of right deltoid pain and swelling secondary to vaccination. States she had influenza, meningocco and pneumococco vaccination on 11/18/19 from ID doctor?s office ? 2 shots in her right deltoid, and 1 shot in her left deltoid.  Skin: Skin is warm and dry. There is erythema (patches of erythematous hives noted on right deltoid area; tenderness to palpation.).
Age: 1.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Onset of pain, swelling, redness (4x2 cm area on exam) occurring 9 days after vaccine administration in left thigh with low-grade fevers. Treated with PO antibiotics (Bactrim DS, weight-based dosing) x 5 days, started today. Will follow up to await outcome of treatment.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Cyanosis, Hyporesponsive to stimuli, Hypotonia
Clinical narrative: Approximately 6 hours post vaccination, child had episode of prolonged hypotonia, cyanosis (with no respiratory distress) and was hyporesponsive. This lasted approximately 10-15 minutes before he became more alert. He was taken to an emergency department after this and was monitored and released. He did not receive CPR or any other intervention.
Age: 33.0
Sex: F
Vaccine: VARCEL
Symptoms: Bacterial infection, Cellulitis, Diarrhoea, Injection site induration, Injection site inflammation
Clinical narrative: Patient developed a rash (no bumps) at the injection site the morning following the vaccination (Thursday).  Her arm also became inflamed, hard and hot.  Patient went to an urgent care facility on Friday (01/31/2020)..  She was prescribed doxycycline 100 mg (1 bid x 10 d) with a diagnosis of bacterial cellulitis.  She developed vomiting, diarrhea and nausea on Sunday (02/02/2020).  Thinking that the GI symptoms were due to the antibiotic, she stopped taking it after three doses.  It has been more that 24 hours since her last dose of doxycycline, yet the GI symptoms are still present.  She also reported some insomnia since the vaccination.  She also received an M-M-R II vaccination in the opposite arm at the same time, but there are no problems at that site.
Age: 33.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site rash, Injection site warmth, Insomnia, Nausea, Vomiting
Clinical narrative: Patient developed a rash (no bumps) at the injection site the morning following the vaccination (Thursday).  Her arm also became inflamed, hard and hot.  Patient went to an urgent care facility on Friday (01/31/2020)..  She was prescribed doxycycline 100 mg (1 bid x 10 d) with a diagnosis of bacterial cellulitis.  She developed vomiting, diarrhea and nausea on Sunday (02/02/2020).  Thinking that the GI symptoms were due to the antibiotic, she stopped taking it after three doses.  It has been more that 24 hours since her last dose of doxycycline, yet the GI symptoms are still present.  She also reported some insomnia since the vaccination.  She also received an M-M-R II vaccination in the opposite arm at the same time, but there are no problems at that site.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Dizziness, Tremor
Clinical narrative: weakness, shakiness, dizziness, chills
Age: 66.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Arthralgia, Erythema, Pain in extremity, Paraesthesia, Skin warm
Clinical narrative: Patient was in to get vaccines on 02/01/2020.  She received three vaccines;  a boostix in her Right arm and a Pneumovax 23 along with a Fluad in her left arm.  She arrived at the pharmacy today with a 3 inch by 4 inch redness below the deltoid and down.  She states her arm started tingling when she received the first vaccine in the left arm and lasted for 2 minutes.  She stated it was very sore into her wrist and under her arm.   It was warm to touch.  I  advised her to reach out to her physician due to the significance of this reaction.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Crying, Injection site erythema, Injection site swelling, Injection site warmth, Irritability
Clinical narrative: Redness, swelling, warmth to left leg from hip to knee.  Child was also fussy, crying.  This lasted through the night but was resolved in the morning.  Parents state they did give Tylenol after speaking with a nurse about these symptoms.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Paraesthesia, Peripheral swelling
Clinical narrative: Patient reported swelling and tingling of fingers on her right hand an hour after Trumenba vaccination.   On exam, right hand was neurovascularly intact with minimal swelling.   No redness or swelling around vaccine site. Treatment included reassurance and monitoring.   Ibuprofen and cool compresses if needed for pain.   Follow up if worse, new symptoms develop or doesn't continue to improve.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Pyrexia
Clinical narrative: Fever, red area around injection site that is warm to the touch, soreness/aching
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Contusion, Dizziness, Erythema, Feeling abnormal
Clinical narrative: Received 1st dose of shingles and Flu in October.  On Tuesday at 12:30pm, patient was feeling puny.  Patient skipped breakfast and started to fade.   Patient went to get lunch and started to feel under the weather similar to flu-like symptoms.   By the time she got to the register, she felt faint, weird and dizzy.  Patient could not even get money out of wallet and asked for help.  Patient then fainted, does not think it was related to medical history or skipping breakfast.  Symptoms were unexpected.   As soon as she stood up she fainted againfainted only lasted for a couple of minutes.   People in the store took patient by the cold air to wait for EMS to arrive.   Per EMS, vitals were normal so given the option to go to the hospital; patient did not go to the hospital.   Patient felt weak so they helped her to her car.  Patient drove home, ate lunch, and then felt so cold she had to raise thermostat.  Patient laid in bed and covered with two thermal blankets.  Patient ate soup for dinner and then slept.  Tuesday, patient reports red, hard knot at arm; took Tylenol.   Symptoms were similar on Wednesday--weak and flu-like symptoms; so stayed home resting.  Yesterday felt better but not great.  Today feels fine but arm is still bruised--that has happened with prior vaccines.   Patient worried about the fainting that occurred.   Patient reports no symptoms after first dose of shingles vaccine.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling cold, Influenza like illness, Nodule, Syncope
Clinical narrative: Received 1st dose of shingles and Flu in October.  On Tuesday at 12:30pm, patient was feeling puny.  Patient skipped breakfast and started to fade.   Patient went to get lunch and started to feel under the weather similar to flu-like symptoms.   By the time she got to the register, she felt faint, weird and dizzy.  Patient could not even get money out of wallet and asked for help.  Patient then fainted, does not think it was related to medical history or skipping breakfast.  Symptoms were unexpected.   As soon as she stood up she fainted againfainted only lasted for a couple of minutes.   People in the store took patient by the cold air to wait for EMS to arrive.   Per EMS, vitals were normal so given the option to go to the hospital; patient did not go to the hospital.   Patient felt weak so they helped her to her car.  Patient drove home, ate lunch, and then felt so cold she had to raise thermostat.  Patient laid in bed and covered with two thermal blankets.  Patient ate soup for dinner and then slept.  Tuesday, patient reports red, hard knot at arm; took Tylenol.   Symptoms were similar on Wednesday--weak and flu-like symptoms; so stayed home resting.  Yesterday felt better but not great.  Today feels fine but arm is still bruised--that has happened with prior vaccines.   Patient worried about the fainting that occurred.   Patient reports no symptoms after first dose of shingles vaccine.
Age: 28.0
Sex: F
Vaccine: FLU4, MMR, TDAP
Symptoms: Dizziness, Vomiting
Clinical narrative: pt felt dizzy and vomited after administration of all 3 vaccines. Felt better after a few minutes no signs or symptoms of trouble breathing or swelling
Age: 72.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Fatigue, Injection site pain, Pain in extremity, Pain of skin
Clinical narrative: Pt reported mild injection site pain and fatigue for a day or so starting the day of immunization. He also reported very sore thighs starting on 2/2/20 (6 days after imz) and very sensitive skin of the thighs.  He reported the skin on his thighs is painful to the touch.
Age: 72.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Asthenia, Blood test normal, Burning sensation, Fatigue, Headache
Clinical narrative: Pt reported mild injection site pain and fatigue for a day or so starting the day of immunization. He also reported very sore thighs starting on 2/2/20 (6 days after imz) and very sensitive skin of the thighs.  He reported the skin on his thighs is painful to the touch.
Age: 72.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Magnetic resonance imaging normal, Pain in extremity
Clinical narrative: Pt reported mild injection site pain and fatigue for a day or so starting the day of immunization. He also reported very sore thighs starting on 2/2/20 (6 days after imz) and very sensitive skin of the thighs.  He reported the skin on his thighs is painful to the touch.
Age: 72.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Asthenia, Burning sensation, Fatigue, Gait disturbance, Headache
Clinical narrative: Pt reported mild injection site pain and fatigue for a day or so starting the day of immunization. He also reported very sore thighs starting on 2/2/20 (6 days after imz) and very sensitive skin of the thighs.  He reported the skin on his thighs is painful to the touch.
Age: 72.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Hyperaesthesia, Laboratory test normal, Limb discomfort, Myalgia, Pain
Clinical narrative: Pt reported mild injection site pain and fatigue for a day or so starting the day of immunization. He also reported very sore thighs starting on 2/2/20 (6 days after imz) and very sensitive skin of the thighs.  He reported the skin on his thighs is painful to the touch.
Age: 72.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Pain in extremity, Pain of skin, Paraesthesia, Tenderness, Urinary retention
Clinical narrative: Pt reported mild injection site pain and fatigue for a day or so starting the day of immunization. He also reported very sore thighs starting on 2/2/20 (6 days after imz) and very sensitive skin of the thighs.  He reported the skin on his thighs is painful to the touch.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: This was my second one, and had the same reaction to both.  Had a fever of about 101, chills and body aches.  Didn't want to move.  Started about 12 hours after injection and was gone after about 30 hours.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Fatigue, Myalgia, Sensitive skin
Clinical narrative: Fatigue. Muscle and joint aches, skin very sensitive - especially to cold touch, edginess
Age: 58.0
Sex: M
Vaccine: FLU4
Symptoms: Angioplasty, Electrocardiogram ST segment elevation, Myocardial infarction, Myocardial necrosis marker increased, Stent placement
Clinical narrative: Flu Shoot given,  Patient had heart attack within 12 hours,  Stents and angioplasty with good prognosis
Age: 58.0
Sex: M
Vaccine: FLU4
Symptoms: Troponin increased
Clinical narrative: Flu Shoot given,  Patient had heart attack within 12 hours,  Stents and angioplasty with good prognosis
Age: 3.0
Sex: F
Vaccine: VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: Fever started on Jan 31 2020 followed by the eruption of a rash on Feb 02 2020
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Chills, Eye swelling, Oedema, Peripheral swelling
Clinical narrative: fever, chills, edema, rash, joint pain see Dr.'s dictation from office visit 2/3/2020 Patient here this morning to talk about a reaction that she believes is secondary to her Shingrix injection. She had her first shot in October and her second 1 at pharmacy on Thursday night. She said that evening she began having chills and fevers and by the next day she started noticing some swelling in her face and eye area. She says when she woke up Saturday morning her eyes were completely swollen shut. She says she feels like there is some fullness in the throat. She says now the swelling in her face is getting better but she has the swelling in  her lower legs and her joints ache. She also thinks she has a little bit of a new rash on her face. She has been taking some Benadryl but all that is doing she says it makes her sleepy.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pyrexia, Rash, Swelling face, Swelling of eyelid, Throat tightness
Clinical narrative: fever, chills, edema, rash, joint pain see Dr.'s dictation from office visit 2/3/2020 Patient here this morning to talk about a reaction that she believes is secondary to her Shingrix injection. She had her first shot in October and her second 1 at pharmacy on Thursday night. She said that evening she began having chills and fevers and by the next day she started noticing some swelling in her face and eye area. She says when she woke up Saturday morning her eyes were completely swollen shut. She says she feels like there is some fullness in the throat. She says now the swelling in her face is getting better but she has the swelling in  her lower legs and her joints ache. She also thinks she has a little bit of a new rash on her face. She has been taking some Benadryl but all that is doing she says it makes her sleepy.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Dysphonia, Feeling cold, Glossodynia, Neuralgia
Clinical narrative: fever, chills, edema, rash, joint pain see Dr.'s dictation from office visit 2/3/2020 Patient here this morning to talk about a reaction that she believes is secondary to her Shingrix injection. She had her first shot in October and her second 1 at pharmacy on Thursday night. She said that evening she began having chills and fevers and by the next day she started noticing some swelling in her face and eye area. She says when she woke up Saturday morning her eyes were completely swollen shut. She says she feels like there is some fullness in the throat. She says now the swelling in her face is getting better but she has the swelling in  her lower legs and her joints ache. She also thinks she has a little bit of a new rash on her face. She has been taking some Benadryl but all that is doing she says it makes her sleepy.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Oral pain, Pain in extremity, Peripheral swelling, Pyrexia, Rash
Clinical narrative: fever, chills, edema, rash, joint pain see Dr.'s dictation from office visit 2/3/2020 Patient here this morning to talk about a reaction that she believes is secondary to her Shingrix injection. She had her first shot in October and her second 1 at pharmacy on Thursday night. She said that evening she began having chills and fevers and by the next day she started noticing some swelling in her face and eye area. She says when she woke up Saturday morning her eyes were completely swollen shut. She says she feels like there is some fullness in the throat. She says now the swelling in her face is getting better but she has the swelling in  her lower legs and her joints ache. She also thinks she has a little bit of a new rash on her face. She has been taking some Benadryl but all that is doing she says it makes her sleepy.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Skin exfoliation, Swelling face
Clinical narrative: fever, chills, edema, rash, joint pain see Dr.'s dictation from office visit 2/3/2020 Patient here this morning to talk about a reaction that she believes is secondary to her Shingrix injection. She had her first shot in October and her second 1 at pharmacy on Thursday night. She said that evening she began having chills and fevers and by the next day she started noticing some swelling in her face and eye area. She says when she woke up Saturday morning her eyes were completely swollen shut. She says she feels like there is some fullness in the throat. She says now the swelling in her face is getting better but she has the swelling in  her lower legs and her joints ache. She also thinks she has a little bit of a new rash on her face. She has been taking some Benadryl but all that is doing she says it makes her sleepy.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Influenza like illness, Injected limb mobility decreased, Injection site coldness, Injection site warmth, Joint stiffness
Clinical narrative: Patient stated she had flu like symptoms and nausea the day after the vaccine for several days. Then she started having "cold and hot spots" in her arm near where she received the vaccine. She also randomly feels like a bee is stinging her.  After more questioning she stated that she still has soreness in the arm and tightness where it is difficult to raise her arm above her head at some points.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Pain, Pain in extremity
Clinical narrative: Patient stated she had flu like symptoms and nausea the day after the vaccine for several days. Then she started having "cold and hot spots" in her arm near where she received the vaccine. She also randomly feels like a bee is stinging her.  After more questioning she stated that she still has soreness in the arm and tightness where it is difficult to raise her arm above her head at some points.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Cough, Diplopia, Dizziness, Fatigue, Vertigo
Clinical narrative: 1/21 Patient wokeup dizzy, had vertigo and double vision, cough + extreme fatigue  1/28 most symptoms were resolved  Patient was prescribed Azithromycin, Meclizine, Benzonatate, Zofran
Age: 45.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site inflammation, Injection site pain, Magnetic resonance imaging, Pain, Product administered at inappropriate site
Clinical narrative: Vaccination administered on 10/4/19, pt was in pain and went to MD's office on 10/7/19. The doctor believes flu shot given high enough on the arm that it penetrated into the bursa sac in the shoulder and is causing inflammation, pain and fever. Patient had MRI and physical therapy.
Age: 45.0
Sex: F
Vaccine: FLUC4
Symptoms: Pyrexia
Clinical narrative: Vaccination administered on 10/4/19, pt was in pain and went to MD's office on 10/7/19. The doctor believes flu shot given high enough on the arm that it penetrated into the bursa sac in the shoulder and is causing inflammation, pain and fever. Patient had MRI and physical therapy.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature increased, Injection site erythema, Injection site pruritus, Injection site swelling, Pain in extremity
Clinical narrative: Patient states that on Thursday 1/30/20 - she has temp of 98.7 (she states her normal temp is 97.) Swollen arm, pain. Friday 1/31/20 - temp 99.8 area is red, pain moved 3 to 4 inches down the right arm. Sunday 2/2/20 - Itchy, red, little swollen, no temperature. Patient states that she did not treat the adverse events with any medication and she feels better at this time and no longer have temperature except that the area itches, area is a little red and swollen.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling
Clinical narrative: Patient states that on Thursday 1/30/20 - she has temp of 98.7 (she states her normal temp is 97.) Swollen arm, pain. Friday 1/31/20 - temp 99.8 area is red, pain moved 3 to 4 inches down the right arm. Sunday 2/2/20 - Itchy, red, little swollen, no temperature. Patient states that she did not treat the adverse events with any medication and she feels better at this time and no longer have temperature except that the area itches, area is a little red and swollen.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Body temperature increased, Headache, Injection site erythema, Injection site pain, Vomiting
Clinical narrative: Reported by mother 1/26/2020:  -Red circle shaped mark about an inch in diameter on Left leg -100 degree temperature -sore leg -headache -vomitting
Age: 69.0
Sex: F
Vaccine: FLU4
Symptoms: Fatigue, Heart rate increased, Muscular weakness, Musculoskeletal pain, Pain in extremity
Clinical narrative: I have sharp pain in my arm and shoulder. I had swelling over my eyes and around them. I have had a fast heart beat, muscle weakness fatigue and shakiness. I got examined at the doctor office. Was prescribed Naproxen 500MG but it does not help the pain I'm feeling.
Age: 69.0
Sex: F
Vaccine: FLU4
Symptoms: Periorbital swelling, Tremor, X-ray limb
Clinical narrative: I have sharp pain in my arm and shoulder. I had swelling over my eyes and around them. I have had a fast heart beat, muscle weakness fatigue and shakiness. I got examined at the doctor office. Was prescribed Naproxen 500MG but it does not help the pain I'm feeling.
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Cellulitis, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient experienced redness, swelling, & warmth at injection site. She was advised to go to urgent care. She was ultimately treated for cellulitis.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Eye pain, Fatigue, Headache, Nausea
Clinical narrative: chills, Fever (102 degrees), severe body ache, headache, nausea, extreme fatigue, eye sockets ached, drawn No treatment other than stay in bed. Fever broke after 18 hours. Other adverse symptoms lasted 8 days.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: chills, Fever (102 degrees), severe body ache, headache, nausea, extreme fatigue, eye sockets ached, drawn No treatment other than stay in bed. Fever broke after 18 hours. Other adverse symptoms lasted 8 days.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Dizziness, Feeling hot, Hyperhidrosis
Clinical narrative: "Hot-legs, sweating, lightheaded" Resolved after approximately 15 minutes, No loss of consciousness. "Weak the next Day" then OK.
Age: 72.0
Sex: F
Vaccine: FLU4
Symptoms: Dysphonia, Urticaria
Clinical narrative: hives, hoarseness developed 17 hours after vaccine treated initially with Benadryl at home but due to no clinical improvement ED visit on 2/4/2020 treated with IV Benadryl, Pepcid and Solu-medrol
Age: 20.0
Sex: M
Vaccine: SMALL
Symptoms: Injection site vesicles
Clinical narrative: Patient was administered the smallpox vaccine on 24Jan2020. On his 7 day smallpox check, patient had a whitish blister at the site. Patient went to the ER on 03Feb2020 for a possible allergic reaction (generalized rash). He was given steroids and an antihistamine and seen at the clinic today, 04Feb2020.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Biopsy, Lichen planus, Rash, Rash pruritic, Urticaria
Clinical narrative: Lichens planus  Corticosteroid injection (extended release), corticosteroid topical (patient discontinued, due to lack of effectiveness), antihistamines oral and topical (tried before seeking medical help)  Itchy rash starting on back then progressing to top of thighs (welts), then arms, now neck going up back of scalp.  When rash progressed to involved all body parts as described, patient sought medical care with dermatologist
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Rash
Clinical narrative: Rash (7/10/19@12:00); Influenza-Like Illness (7/10/19@12:00)
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Discomfort, Pain
Clinical narrative: he had experienced pain and discomfort after having received two vaccines: RZV and PPSV23; he had experienced pain and discomfort after having received two vaccines: RZV and PPSV23; This spontaneous report was received from a patient's friend and refers to a male patient of unknown age who reported via social media. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On an unknown dates the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, (reported as PPSV23) and with zoster vaccine live (ZOSTAVAX) injection, (reported as RZV), (strength, dose, frequency, route of administration, lot # and expiration date were not reported for both) for prophylaxis.  On an unknown date the patient experienced pain and discomfort.  The action taken, outcome and relatedness between the events and suspect therapies were not provided.
Sex: F
Vaccine: UNK, VARCEL
Symptoms: Antibody test abnormal
Clinical narrative: titers were found to be "low"; This spontaneous report was received from a pharmacist referring to a female patient in late twenties. The patient had never had chicken pox. The patient's concomitant medication and current condition were unknown.  At unspecified times in her youth, the patient had childhood vaccination with 2 doses of varicella virus vaccine live (oka/merck) (VARIVAX) (strength, frequency, route, lot# and expiration date unknown) with sterile diluent (MERCK STERILE DILUENT) (lot# and expiration date unknown) for varicella prevention.  In approximately May 2019 (reported as around time of delivering baby near 8 months ago), the patient was tested was tested for immunity (titers), and titers were found to be "low" (not defined) (antibody test abnormal).  The Pharmacist considered it was suspected that the patient did receive 2 doses of varicella virus vaccine live (oka/merck) (VARIVAX). No follow up titers had been drawn. No other symptoms was reported. The outcome of titers low was reported as recovered.  The causality between suspect therapies and titers low was not reported.
Sex: U
Vaccine: HPV9
Symptoms: Postural orthostatic tachycardia syndrome
Clinical narrative: GARDASIL 9 causes postural orthostatic tachycardia syndrome; This spontaneous report was received from a physician via a company representative regarding unspecified patients of an unknown age and gender seen on social media. Details on pertinent medical history, concomitant medications and previously drug reactions or allergies were unknown by the reporter.  It was reported that parents of unspecified patients told the physician that they have seen on social media that HPV RL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast)(GARDASIL 9) caused postural orthostatic tachycardia syndrome.  Therefore, it was reported that on unknown dates, unspecified patients could have potentially been vaccinated with HPV RL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast)(GARDASIL 9) injection (INJ), intramuscularly to prevent certain human papilloma virus (HPV) related cancers (prophylaxis) (strength, dose, dose number, and frequency were not reported; lot number, and expiration date were unknown by the reporter), and then the patients were diagnosed with postural orthostatic tachycardia syndrome, however the physician reported that was unaware of any patients being administered HPV RL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast)(GARDASIL 9) and then being diagnosed with the aforementioned event. The event was not reported as a cancer event, or if it was related to a congenital anomaly. Furthermore, it was unknown by the reporter if treatment was given for the event, or if laboratory diagnostics or studies were performed to the patient.  It was not reported if the patients continued with the schedule of the suspect therapy. At the time of this report, outcome of the event postural orthostatic tachycardia syndrome was reported as unknown.  The parents of the unspecified patients considered the aforementioned event postural orthostatic tachycardia syndrome to be causally related to HPV RL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast)(GARDASIL 9), however the reporter did not provide a causality assessment between the event and the suspect therapy.  This is a non-valid case due to lack of patient identifier.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse events reported; improperly stored vaccines may have been administered to patients; This spontaneous report has been received from a nurse, referring to patient of unknown gender and age. Information about the patient's pertinent medical history, concurrent conditions, and previous drugs reactions or allergies were not provided. Concomitant therapies included sterile diluent (MERCK STERILE DILUENT).  On 10-JAN-2020, the patient was vaccinated with an improperly stored (product storage error) varicella virus vaccine live (oka/merck) (VARIVAX) (Therapy type: Digital Data Logger), lot number S003448 and expiration date 04-FEB-2021 for prophylaxis (strength, dose, dose number, frequency, route of administration, and anatomical location, were not provided). The sterile diluent (MERCK STERILE DILUENT) used for reconstitution was properly stored (lot number S025291 had not been valid upon internal validation; expiration date 23-APR-2022).  The vaccine was stored at a temperature from  6 degree Fahrenheit to 14 degree Fahrenheit (7.2 Fahrenheit), for a timeframe of 25 minutes, with no previous temperature excursion. The call was due to a Digital Data Logger.  No additional adverse events were reported.  This case is one of several cases from the same reporter; Sender's Comments:  US-009507513-2001USA009007:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse events reported; improperly stored vaccines may have been administered to patients; This spontaneous report has been received from a nurse, referring to patient of unknown gender and age. Information about the patient's pertinent medical history, concurrent conditions, and previous drugs reactions or allergies were not provided. Concomitant therapies included sterile diluent (MERCK STERILE DILUENT).  On 31-DEC-2019, the patient was vaccinated with an improperly stored (product storage error) varicella virus vaccine live (oka/merck) (VARIVAX) (Therapy type: Digital Data Logger), lot number S003448 and expiration date 04-FEB-2021 for prophylaxis (strength, dose, dose number, frequency, route of administration, and anatomical location, were not provided). The sterile diluent (MERCK STERILE DILUENT) used for reconstitution was properly stored (lot number S025291 had not been valid upon internal validation; expiration date 23-APR-2022).  The vaccine was stored at a temperature from 6 degree Fahrenheit to 14 degree Fahrenheit (7.2 Fahrenheit), for a timeframe of 25 minutes, with no previous temperature excursion. The call was due to a Digital Data Logger.  No additional adverse events were reported.  This case is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2001USA009007:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse events reported; improperly stored vaccines may have been administered to patients; This spontaneous report has been received from a nurse, referring to patient of unknown gender and age. Information about the patient's pertinent medical history, concurrent conditions, and previous drugs reactions or allergies were not provided. Concomitant therapies included sterile diluent (MERCK STERILE DILUENT).  On 06-JAN-2020, the patient was vaccinated with an improperly stored (product storage error) varicella virus vaccine live (oka/merck) (VARIVAX) (Therapy type: Digital Data Logger), lot number S003448 and expiration date 04-FEB-2021 for prophylaxis (strength, dose, dose number, frequency, route of administration, and anatomical location, were not provided). The sterile diluent (MERCK STERILE DILUENT) used for reconstitution was properly stored (lot number S025291 had not been valid upon internal validation; expiration date 23-APR-2022).  The vaccine was stored at a temperature from 6 degree Fahrenheit to 14 degree Fahrenheit (7.2 Fahrenheit), for a timeframe of 25 minutes, with no previous temperature excursion. The call was due to a Digital Data Logger.  No additional adverse events were reported.  This case is one of several cases from the same reporter; Sender's Comments:  US-009507513-2001USA009007:
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Muscular weakness, Musculoskeletal pain, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Plaintiff suffered severe pain in shoulders, fingers, hips and weakness/stiffness in arm. Plaintiff was diagnosed with polymyalgia rheumatica; Information has been received from a lawyer referring to a female patient (pt) of unknown age regarding a case in litigation. The pt's pertinent medical history, concurrent conditions and concomitant medications were not provided.  On or about 17-JUN-2017, the pt was inoculated with zoster vaccine live (ZOSTAVAX) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX) vaccine, on an unknown date, the pt suffered severe pain in shoulders, fingers, hips and weakness/stiffness in arm which was diagnosed as polymyalgia rheumatica. As a direct and proximate result of defective zoster vaccine live (ZOSTAVAX) vaccine, pt's symptoms had resulted in physical limitations not present prior to using the product and additionally, also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. Pt sustained severe and permanent personal injuries and suffered serious, progressive, permanent and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. She also suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages.  At the reporting time, the pt was not recovered from polymyalgia rheumatica and it was considered to be related to zoster vaccine live (ZOSTAVAX).     Upon internal review, polymyalgia rheumatica was considered a medically significant event.
Sex: F
Vaccine: VARZOS
Symptoms: Polymyalgia rheumatica
Clinical narrative: Plaintiff suffered severe pain in shoulders, fingers, hips and weakness/stiffness in arm. Plaintiff was diagnosed with polymyalgia rheumatica; Information has been received from a lawyer referring to a female patient (pt) of unknown age regarding a case in litigation. The pt's pertinent medical history, concurrent conditions and concomitant medications were not provided.  On or about 17-JUN-2017, the pt was inoculated with zoster vaccine live (ZOSTAVAX) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX) vaccine, on an unknown date, the pt suffered severe pain in shoulders, fingers, hips and weakness/stiffness in arm which was diagnosed as polymyalgia rheumatica. As a direct and proximate result of defective zoster vaccine live (ZOSTAVAX) vaccine, pt's symptoms had resulted in physical limitations not present prior to using the product and additionally, also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. Pt sustained severe and permanent personal injuries and suffered serious, progressive, permanent and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. She also suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages.  At the reporting time, the pt was not recovered from polymyalgia rheumatica and it was considered to be related to zoster vaccine live (ZOSTAVAX).     Upon internal review, polymyalgia rheumatica was considered a medically significant event.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Plaintiff suffered shingles; Information has been received from a lawyer referring to a female patient (pt) of unknown age regarding a case in litigation. The pt's pertinent medical history, concurrent conditions and concomitant medications were not provided.  In or around September 2017, the pt was inoculated with zoster vaccine live (ZOSTAVAX) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX) vaccine, on an unspecified date, pt suffered shingles (herpes zoster) and as a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, pt's symptoms had resulted in physical limitations not present prior to using this product. She also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. Additionally, pt sustained severe and permanent personal injuries and suffered serious, progressive, permanent and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. Pt also had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages.  At the reporting time, the pt was not recovered from shingles and it was considered to be related to zoster vaccine live (ZOSTAVAX).    Herpes zoster was considered a disabling event.
Sex: F
Vaccine: VARCEL
Symptoms: Incorrect route of product administration, Myalgia
Clinical narrative: injection site muscle soreness; patient received her first dose of VARIVAX, intramuscularly; This spontaneous report was received from a nurse, regarding a 42-year-old non-pregnant, female patient. The patient's concomitant medications included sterile diluent (manufacturer unknown), rizatriptan benzoate (MAXALT MLT) and (XANAX). It was reported that the patient did not have any pertinent medical history. His drug reactions or allergies included a penicillin allergy.   On 15-NOV-2019, the patient was vaccinated with a first dose of varicella virus vaccine live (Oka/Merck) (VARIVAX), 0.5 ml once, intramuscularly as routine immunization (prophylaxis) (incorrect route of product administration) (anatomical location was not provided; lot number S020158, expiration date reported as 30-JUN-2021, and upon internal validation stablished as the same).   On that same day, the patient experienced muscle soreness (myalgia). It was reported that no laboratories or diagnostics tests were performed, and that the patient did not seek medical attention. The patient recovered from the event on approximately 19-NOV-2019 (reported as: after three to four days).   There was no causality assessment provided between myalgia occurrence and vaccination with varicella virus vaccine live (Oka/Merck) (VARIVAX).