chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Vomiting projectile
Clinical narrative: Had the shot 10 am. At 7 pm felt fatigued , a bit of an upset stomach. The following day was tired, had a headache (I very rarely have a headache!) and around 5 pm had severe chills , my chin couldn?t stop shaking. And muscle aches . Then bad diahreah came on quickly and continued from 9 pm to 4:00 am at which time is got very dizzy , then blacked out and woke up with my face on the carpet. Then projectile vomited five times while I was calling 911 as I was alone at the house and didn?t want to pass out again. Taken by ambulance to emergency room. Temp was 100.1. Given 2 x 1000  cc water intervenously. Was released at 8 am - still very nauseated , but better , took one zophran through out that day. Continued to be severely fatigued but no fever . Was in bed for the following three days due to fatigue.  I write down everything I eat so reviewed and all was normal stuff that my husband had also eaten and I hadn?t gone out to eat for several days prior. I had a reaction to the first shingles shot though not as severe. Was fatigued for two days and upset stomach with first shot. Never had reactions to any other shots .
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Headache, Injection site warmth, Pruritus, Swelling
Clinical narrative: Itching, swelling, redness, headache, and hot to the touch at injection site.  Provider prescribed cephalexin 250mg.
Age: 7.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Injection site urticaria, Injection site warmth
Clinical narrative: Mom called because she received flu shot on Tuesday and on Wednesday she had a baseball sized welt that was warm to the touch.  She hadn't been with her the past couple of days but upon seeing her on Friday, she states the swelling has moved to the back of her arm and is still warm to touch.  Vaccine reaction: seen in office, swollen red arm.  Warm compress and alternate Tylenol and Motrin every 4 hours.
Age: 0.33
Sex: M
Vaccine: HIBV, PNC13
Symptoms: Decreased eye contact, Hyperacusis, Hypotonia, Mobility decreased, Photophobia
Clinical narrative: Lack of eye contact and reaction to sites and noises, would not use arms when typically he would reach for things. His body was just limp and uncharacteristically unresponsive. Warm bath given with mom while nursing and massaging baby trying to stimulate his arms torso and legs. Put a call into the dr and was told to monitor him. Roughly 12 hours later he  perked back up.
Age: 0.33
Sex: M
Vaccine: HIBV, PNC13
Symptoms: Unresponsive to stimuli
Clinical narrative: Lack of eye contact and reaction to sites and noises, would not use arms when typically he would reach for things. His body was just limp and uncharacteristically unresponsive. Warm bath given with mom while nursing and massaging baby trying to stimulate his arms torso and legs. Put a call into the dr and was told to monitor him. Roughly 12 hours later he  perked back up.
Age: 38.0
Sex: F
Vaccine: TD
Symptoms: Diarrhoea, Diarrhoea haemorrhagic, Hyperhidrosis, Vomiting
Clinical narrative: Profuse sweating, bloody/mucous diarrhea/vomiting x 2 days
Age: 33.0
Sex: F
Vaccine: HPV9
Symptoms: Blood test abnormal, Impaired work ability, Inflammation, Injection site inflammation, Injection site pain
Clinical narrative: Shoulder pain and inability to move arm after 2nd shot. Which was in January 2019. Shoulder pain progressed, reported to doctors and they said it was nothing. Got 3rd shot on 7/12/2019 and on 7/15/2019 had shoulder pain that made me call off of work, joint was stiff for at least 3 days. Over the last months pain and inflammation has spread to neck, both shoulders, fingers are swollen and has now spread to feet.
Age: 33.0
Sex: F
Vaccine: HPV9
Symptoms: Joint stiffness, Mobility decreased, Musculoskeletal pain, Neck pain, Peripheral swelling
Clinical narrative: Shoulder pain and inability to move arm after 2nd shot. Which was in January 2019. Shoulder pain progressed, reported to doctors and they said it was nothing. Got 3rd shot on 7/12/2019 and on 7/15/2019 had shoulder pain that made me call off of work, joint was stiff for at least 3 days. Over the last months pain and inflammation has spread to neck, both shoulders, fingers are swollen and has now spread to feet.
Age: 33.0
Sex: F
Vaccine: HPV9
Symptoms: Rheumatoid arthritis, Rheumatoid factor increased
Clinical narrative: Shoulder pain and inability to move arm after 2nd shot. Which was in January 2019. Shoulder pain progressed, reported to doctors and they said it was nothing. Got 3rd shot on 7/12/2019 and on 7/15/2019 had shoulder pain that made me call off of work, joint was stiff for at least 3 days. Over the last months pain and inflammation has spread to neck, both shoulders, fingers are swollen and has now spread to feet.
Age: 88.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood test, Fatigue, Pain of skin, Rash, Rash erythematous
Clinical narrative: Patient describes rash of small red dots all over body starting the morning after having received the vaccine. This rash was extremely itchy, especially in the arm of the injection site, which was also very red. She also became very fatigued beginning the day after receiving the vaccine, and she experienced pain in the skin of her abdomen.  These symptoms lasted until yesterday, 1/19/2020. Patient saw her medical doctor today, who drew blood labs to determine if she experienced an allergic reaction to the vaccine. Doctor also recommended that she notify the health department so that we could file a report with VAERS.
Age: 88.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash pruritic
Clinical narrative: Patient describes rash of small red dots all over body starting the morning after having received the vaccine. This rash was extremely itchy, especially in the arm of the injection site, which was also very red. She also became very fatigued beginning the day after receiving the vaccine, and she experienced pain in the skin of her abdomen.  These symptoms lasted until yesterday, 1/19/2020. Patient saw her medical doctor today, who drew blood labs to determine if she experienced an allergic reaction to the vaccine. Doctor also recommended that she notify the health department so that we could file a report with VAERS.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Erythema, Feeling abnormal, Headache, Malaise
Clinical narrative: Left arm had swelling, redness and very sore (much worse than first shot!) starting that evening.  I had a restless night due to just not feeling well.  I got up at 6:30 am Saturday, Jan. 16, with a horrific headache and just not feeling right.  Had to fly on a plane for a meeting at 10 am.  While in the airport I felt very nauseous and although wanted to take ibuprofen for headache and sore muscle feeling, I couldn't.  I put the vomit bag in my hand during the flight just in case.  I never threw up but felt terrible.  Upon arriving to the hotel, I checked in, chanced taking ibuprofen due to such a bad headache and went to bed for 1 1/2 hrs as I had no energy.  When I woke up I went to my meeting and began to experience itching on my chest and stomach.  About 4:30 my headache lessened and I could focus on the meeting better.  That night I noticed a few red bumps and continued itching.  By the next morning I had red scabby bumps on my chest and stomach.  No headache.  But tingling on the left side of my neck and jaw.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Nausea, Pain in extremity, Paraesthesia, Peripheral swelling
Clinical narrative: Left arm had swelling, redness and very sore (much worse than first shot!) starting that evening.  I had a restless night due to just not feeling well.  I got up at 6:30 am Saturday, Jan. 16, with a horrific headache and just not feeling right.  Had to fly on a plane for a meeting at 10 am.  While in the airport I felt very nauseous and although wanted to take ibuprofen for headache and sore muscle feeling, I couldn't.  I put the vomit bag in my hand during the flight just in case.  I never threw up but felt terrible.  Upon arriving to the hotel, I checked in, chanced taking ibuprofen due to such a bad headache and went to bed for 1 1/2 hrs as I had no energy.  When I woke up I went to my meeting and began to experience itching on my chest and stomach.  About 4:30 my headache lessened and I could focus on the meeting better.  That night I noticed a few red bumps and continued itching.  By the next morning I had red scabby bumps on my chest and stomach.  No headache.  But tingling on the left side of my neck and jaw.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash, Rash erythematous, Restlessness
Clinical narrative: Left arm had swelling, redness and very sore (much worse than first shot!) starting that evening.  I had a restless night due to just not feeling well.  I got up at 6:30 am Saturday, Jan. 16, with a horrific headache and just not feeling right.  Had to fly on a plane for a meeting at 10 am.  While in the airport I felt very nauseous and although wanted to take ibuprofen for headache and sore muscle feeling, I couldn't.  I put the vomit bag in my hand during the flight just in case.  I never threw up but felt terrible.  Upon arriving to the hotel, I checked in, chanced taking ibuprofen due to such a bad headache and went to bed for 1 1/2 hrs as I had no energy.  When I woke up I went to my meeting and began to experience itching on my chest and stomach.  About 4:30 my headache lessened and I could focus on the meeting better.  That night I noticed a few red bumps and continued itching.  By the next morning I had red scabby bumps on my chest and stomach.  No headache.  But tingling on the left side of my neck and jaw.
Age: 75.0
Sex: M
Vaccine: FLU4
Symptoms: Extra dose administered
Clinical narrative: Patient was given a flu shot on 10/10/2019 but shot was not completely filled out in chart so it was not visible that one had been administered. Patient came in on 12/23/19 and was given a 2nd shot with a different lot #.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Patient claims she cannot move her arm freely after receiving the vaccine.  The arm still hurts and is getting worse each day. There was no redness/swelling at the site of injection
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Throat irritation, Throat tightness, Urticaria
Clinical narrative: First, my throat was very itchy  Then, throat started getting very tight Then my hands starting getting large welts in them
Age: 86.0
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: An unscheduled Second dose of the flu was given in the same Flu season
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Vision blurred
Clinical narrative: DIZZINESS AND BLURRED VISION
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Fall
Clinical narrative: Before walking out of the room, I asked patient if he was ok, nodded and said "yes". 5 minutes post administration, patient fell off the table. Patient stated "didn't know he was on the ground" or "what had happened". BP was taken 100/52. Pt was kept and monitored for an additional 15 mins. Physician was called to assess patient. No c/o pain/HA.
Age: 80.0
Sex: F
Vaccine: PPV
Symptoms: Injection site discolouration, Injection site erythema, Injection site irritation, Injection site paraesthesia, Injection site swelling
Clinical narrative: Patient described adverse event starting with her arm feeling sore, and hard to move. She later removed long sleeve shirt and noticed that the arm was red in color below the sight of injection and warm to touch. It later progressed to become swollen and began to move down her arm towards the elbow area. She went to a local 24 hour pharmacy around 3:30 am and was instructed by the pharmacist to began taking Benadryl 50mg by mouth every 4 hours as needed. She reported it to have helped. She continued taking it and then came into the pharmacy on 1/17/20 to show myself and the pharmacist on duty. The pharmacist advised her to continue taking the Benadryl as directed and if worried could go to an urgent care to be seen. Patient takes advice and gets seen at a local urgent care. She was given a prescription to treat adverse effect as it were cellulitis. Prescription reads Cephalexin 500mg by mouth every 12 hours for 10 days. Patient was counseled on the antibiotic and a phone call was made today (1/20/20) to ask patient how she was doing. Patient described the pain and swelling in her arm to have decreased. She said the colored changed to a brown color and appears as if it were a bruise. She described the feeling as irritated, and feeling asleep with a tingle.
Age: 80.0
Sex: F
Vaccine: PPV
Symptoms: Injection site warmth, Mobility decreased, Pain in extremity
Clinical narrative: Patient described adverse event starting with her arm feeling sore, and hard to move. She later removed long sleeve shirt and noticed that the arm was red in color below the sight of injection and warm to touch. It later progressed to become swollen and began to move down her arm towards the elbow area. She went to a local 24 hour pharmacy around 3:30 am and was instructed by the pharmacist to began taking Benadryl 50mg by mouth every 4 hours as needed. She reported it to have helped. She continued taking it and then came into the pharmacy on 1/17/20 to show myself and the pharmacist on duty. The pharmacist advised her to continue taking the Benadryl as directed and if worried could go to an urgent care to be seen. Patient takes advice and gets seen at a local urgent care. She was given a prescription to treat adverse effect as it were cellulitis. Prescription reads Cephalexin 500mg by mouth every 12 hours for 10 days. Patient was counseled on the antibiotic and a phone call was made today (1/20/20) to ask patient how she was doing. Patient described the pain and swelling in her arm to have decreased. She said the colored changed to a brown color and appears as if it were a bruise. She described the feeling as irritated, and feeling asleep with a tingle.
Age: 54.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Erythema, Herpes zoster, Pain, Rash
Clinical narrative: Patient was administered Fluzone Quad and Shingrix on same day 11/18/2019. Patient presented with rash and redness on upper arm 1/11/2020. Went to physician and received medrol dose pack. Pain increased and went to physician 1/20/2020 and diagnosed with shingles.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Peripheral swelling, Pruritus
Clinical narrative: Patient's arm was had a  raised, red swollen area and was itchy
Age: 94.0
Sex: F
Vaccine: FLUA3
Symptoms: Blood test, Culture urine positive, Dyskinesia, Fatigue, Neurological symptom
Clinical narrative: Starting day after vaccine, patient started showing neurological side effects: tic and circling of head and body, swaying back and forth, unable to sit straight upright, and increased fatigue - unable to stay up all day.  1/16/2020: saw MD, did urine culture. 1/19 took patient to the ER, diagnosis of UTI. Started antibiotics 1/20 according to culture and sensitivity. After 1 dose of Augmentin, starting to see improvements of neurological symptoms.   Neurological symptoms likely due to UTI.
Age: 94.0
Sex: F
Vaccine: FLUA3
Symptoms: Posture abnormal, Tic, Urinary tract infection
Clinical narrative: Starting day after vaccine, patient started showing neurological side effects: tic and circling of head and body, swaying back and forth, unable to sit straight upright, and increased fatigue - unable to stay up all day.  1/16/2020: saw MD, did urine culture. 1/19 took patient to the ER, diagnosis of UTI. Started antibiotics 1/20 according to culture and sensitivity. After 1 dose of Augmentin, starting to see improvements of neurological symptoms.   Neurological symptoms likely due to UTI.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash erythematous
Clinical narrative: The day after the shot, the patient experienced red bumps on her arms and legs usually on folded areas and bony areas which lasted for 2 weeks. She didn't take any medicines because she was thinking at that time because she was shaving and she was more concerned on her husband who had more severe allergic reaction to the shot. After 2 weeks it dried up and went away. It only now that she was telling this to us because I called her for her second dose and on her way here he remembered that she had the same reaction as her husband but was not as bad as his.
Age: 10.0
Sex: M
Vaccine: FLU4, TDAP
Symptoms: Balance disorder, Blood glucose increased, Hyperhidrosis, Nausea, Seizure
Clinical narrative: Less than 10 min of vaccine administration patient lost balance and started with convulsions, after 30 + min of observation patient started sweating and became nausea and went sent to Emergency Room by ambulance for further observation
Age: 71.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Asthenia, Choking, Dizziness, Dyspnoea, Feeling hot
Clinical narrative: Patient reports no problems with first dose. Overnight arm was in pain; did not take any medicine/treatment.  At around 11am felt warm, felt like if choking/breathing harder than usual, feels congested, weak, and had to get into bed to rest. Patient had appetite and was able to eat.  Patient still feels hot/feverish, can't get up, dizzy, has a headache and is congested.
Age: 71.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Headache, Mobility decreased, Pain in extremity, Pyrexia, Respiratory tract congestion
Clinical narrative: Patient reports no problems with first dose. Overnight arm was in pain; did not take any medicine/treatment.  At around 11am felt warm, felt like if choking/breathing harder than usual, feels congested, weak, and had to get into bed to rest. Patient had appetite and was able to eat.  Patient still feels hot/feverish, can't get up, dizzy, has a headache and is congested.
Age: 71.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Influenza like illness
Clinical narrative: Patient reports no problems with first dose. Overnight arm was in pain; did not take any medicine/treatment.  At around 11am felt warm, felt like if choking/breathing harder than usual, feels congested, weak, and had to get into bed to rest. Patient had appetite and was able to eat.  Patient still feels hot/feverish, can't get up, dizzy, has a headache and is congested.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Peripheral swelling
Clinical narrative: redness and swelling on the left deltoid for 2 days
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Patient received flu vaccine and reported her arm hurt and was sore for 5 days. She felt it was unusual because she did not have such extended arm soreness when she had flu shots in the past.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: patient complained to pharmacist on duty on 9/27/19 of having welts on shoulder and torso that comes on and off, starting one day after having injection. He was advised to take benadyl  and follow up with his primary doctor.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Chest pain, Immediate post-injection reaction, Injection site pain, Pain, Spinal pain
Clinical narrative: Pain at injection site immediately after injection. Then the painful area kept getting worse and larger. Currently, the front and back of right upper arm and shoulder are very painful, 100% of the time, especially with movement of the shoulder joint, even passive movement. Also, front of chest is painful all the time, worse with movement of right arm and shoulder, and upper thoracic spine on right is painful all the time, worse with movement. The whole area is much more sensitive to touch than before the shot.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Tenderness
Clinical narrative: Pain at injection site immediately after injection. Then the painful area kept getting worse and larger. Currently, the front and back of right upper arm and shoulder are very painful, 100% of the time, especially with movement of the shoulder joint, even passive movement. Also, front of chest is painful all the time, worse with movement of right arm and shoulder, and upper thoracic spine on right is painful all the time, worse with movement. The whole area is much more sensitive to touch than before the shot.
Age: 77.0
Sex: F
Vaccine: PNC13
Symptoms: Pain in extremity, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: Patient arm swelled up and is warm to touch and it itches and pains patient
Age: 1.08
Sex: M
Vaccine: FLU4, HEPA, MMR, VARCEL
Symptoms: Injection site urticaria
Clinical narrative: Developed a small wheal immediately adjacent to both MMR + Varicella injections (opposite thighs)
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Chest discomfort, Chills, Musculoskeletal pain
Clinical narrative: Patient stated that she experienced chills, shoulder pain, and chest tightness for 2 days after the administration.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Hypersomnia, Influenza like illness, Injection site erythema, Injection site pruritus
Clinical narrative: Left arm red hot from top of shoulder toward elbow. Migraine headache. Swollen and sore lymph nodes under left arm. Fluid in left arm, Fatigue Had first Shingrix vaccine on Friday, January 10, 2020, at Pharmacy - 10:49am Slept from 9:30 pm Friday night to 1:30pm Saturday - 16 hours Woke up - was achy - like flu Left arm red hot from top of shoulder down toward elbow (to my scar) - about 8" long and about 4-5" wide Had migraine-like headache Slept Saturday night from 8:30pm to Sunday 10:30 am - 14 hours Woke up with swollen and sore lymph nodes under left arm Arm continued to get redder and hotter Slept Monday night from 9:30pm - 7:30am - 10 hours redness down the inside of my arm and down my side lymph nodes more sore fluid in redness on my arm - made skin sag Wed. 15th - went to Family Medicine - FNP She suggested reporting this to Center for Disease Control Still sleeping at least 10 hours a night. I usually sleep from 11:30p-6:30am Sunday - 19th went to pharmacy to get info on the manufacturer, vaccine brand name, lot number, where given. Redness better. Area now itchy. Monday - January 20 - 9am appointment with staff at Clinic to fill out form for CDC - VAERS My question is - Should I take the 2nd shot? If so, should I wait until later in the time window? Does taking an antihistamine prior to the shot, weaken the effectiveness of the vaccine?
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Lymph node pain, Lymphadenopathy, Migraine, Oedema peripheral
Clinical narrative: Left arm red hot from top of shoulder toward elbow. Migraine headache. Swollen and sore lymph nodes under left arm. Fluid in left arm, Fatigue Had first Shingrix vaccine on Friday, January 10, 2020, at Pharmacy - 10:49am Slept from 9:30 pm Friday night to 1:30pm Saturday - 16 hours Woke up - was achy - like flu Left arm red hot from top of shoulder down toward elbow (to my scar) - about 8" long and about 4-5" wide Had migraine-like headache Slept Saturday night from 8:30pm to Sunday 10:30 am - 14 hours Woke up with swollen and sore lymph nodes under left arm Arm continued to get redder and hotter Slept Monday night from 9:30pm - 7:30am - 10 hours redness down the inside of my arm and down my side lymph nodes more sore fluid in redness on my arm - made skin sag Wed. 15th - went to Family Medicine - FNP She suggested reporting this to Center for Disease Control Still sleeping at least 10 hours a night. I usually sleep from 11:30p-6:30am Sunday - 19th went to pharmacy to get info on the manufacturer, vaccine brand name, lot number, where given. Redness better. Area now itchy. Monday - January 20 - 9am appointment with staff at Clinic to fill out form for CDC - VAERS My question is - Should I take the 2nd shot? If so, should I wait until later in the time window? Does taking an antihistamine prior to the shot, weaken the effectiveness of the vaccine?
Age: 5.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: 3 inch red, raised area at injection site. Started the following day & increased from 2.5 inches to 3 inches in diameter overnight. Painful to pt with pressure Applied.
Age: 14.0
Sex: M
Vaccine: HPV9
Symptoms: Cold sweat, Dizziness, Fatigue, Loss of consciousness, Muscle rigidity
Clinical narrative: He said he was going to pass out /  unresponsive for approximately 15 seconds to a minute; he got rigid; starting shaking; bit his tongue; felt cold; clammy; feels tired; Dizzy; This report was identified from a line listing obtained on request by the Company from the FDA (Agency number: 809754) on 11-NOV-2019 referring to a 14-year-old male patient. The patient's allergies, concomitant medications, chronic or long-standing health condition, or any illness at vaccination time and up to month prior were unknown. It was not reported if the patient had ever had an adverse event following a previous vaccine. His medical history included dizziness and historical vaccines included HPV vaccine.  On 05-APR-2019, at the age of 14-years-old, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) intramuscularly (IM) in the right arm, as prophylaxis (strength, and dose not reported; lot number R011630 has been verified to be a valid lot number, expiration date not reported, but upon internal validation established as 12-DEC-2020).   On the same day, after the vaccination the patient lied supine for a few minutes, drank some water and he left the clinic with his father and as they were driving within 5 minutes, he turned to his father and said he was going to "pass out", the patient got rigid (muscle rigidity), started shaking  (tremor) and bit his tongue (tongue biting), unresponsive for approximately 15 seconds to a minute (loss of consciousness), afterward. He came to and felt cold and clammy (sweat cold). The patient was able to get out of the car and walked into the house. His father gave him juice and then sat in a chair and felt tired (fatigue). No medical test and laboratory results were reported.  At the time of reporting, the patient recovered from the events.  The causality relationship between the suspect vaccine, and the events occurrence was not reported.  Follow-up has been received from a registered nurse on 13-JAN-2019.  It was confirmed that the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) on the right arm, intramuscularly, on the deltoid side on 05-APR-2019. It was reported that the patient additionally experienced dizziness on that day and all the events included loss of consciousness, rigidity and shaking lasted for fifteen seconds to one minute. Therefore, the patient recovered on the same date.   The causality relationship between vaccination with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) and the events loss of consciousness, shaking, rigidity, and dizziness was considered related by the reporter.  Upon internal review, the event loss of consciousness was determined to be a medically significant event.
Age: 14.0
Sex: M
Vaccine: HPV9
Symptoms: Tongue biting, Tremor, Unresponsive to stimuli
Clinical narrative: He said he was going to pass out /  unresponsive for approximately 15 seconds to a minute; he got rigid; starting shaking; bit his tongue; felt cold; clammy; feels tired; Dizzy; This report was identified from a line listing obtained on request by the Company from the FDA (Agency number: 809754) on 11-NOV-2019 referring to a 14-year-old male patient. The patient's allergies, concomitant medications, chronic or long-standing health condition, or any illness at vaccination time and up to month prior were unknown. It was not reported if the patient had ever had an adverse event following a previous vaccine. His medical history included dizziness and historical vaccines included HPV vaccine.  On 05-APR-2019, at the age of 14-years-old, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) intramuscularly (IM) in the right arm, as prophylaxis (strength, and dose not reported; lot number R011630 has been verified to be a valid lot number, expiration date not reported, but upon internal validation established as 12-DEC-2020).   On the same day, after the vaccination the patient lied supine for a few minutes, drank some water and he left the clinic with his father and as they were driving within 5 minutes, he turned to his father and said he was going to "pass out", the patient got rigid (muscle rigidity), started shaking  (tremor) and bit his tongue (tongue biting), unresponsive for approximately 15 seconds to a minute (loss of consciousness), afterward. He came to and felt cold and clammy (sweat cold). The patient was able to get out of the car and walked into the house. His father gave him juice and then sat in a chair and felt tired (fatigue). No medical test and laboratory results were reported.  At the time of reporting, the patient recovered from the events.  The causality relationship between the suspect vaccine, and the events occurrence was not reported.  Follow-up has been received from a registered nurse on 13-JAN-2019.  It was confirmed that the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) on the right arm, intramuscularly, on the deltoid side on 05-APR-2019. It was reported that the patient additionally experienced dizziness on that day and all the events included loss of consciousness, rigidity and shaking lasted for fifteen seconds to one minute. Therefore, the patient recovered on the same date.   The causality relationship between vaccination with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) and the events loss of consciousness, shaking, rigidity, and dizziness was considered related by the reporter.  Upon internal review, the event loss of consciousness was determined to be a medically significant event.
Age: 75.0
Sex: F
Vaccine: UNK, VARZOS
Symptoms: Rash maculo-papular
Clinical narrative: diffuse maculopapular rash starting 11/27, improved with steroids, and then returned 3 days later, lasting until January
Age: 75.0
Sex: F
Vaccine: UNK, VARZOS
Symptoms: Hypersensitivity, Rash, Urticaria
Clinical narrative: diffuse maculopapular rash starting 11/27, improved with steroids, and then returned 3 days later, lasting until January
Age: 65.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Injection site erythema
Clinical narrative: "erythema" at the injection site; This spontaneous report was received from a pharmacist referring to a 65 years old male patient. Information about medical history, concurrent conditions and concomitant therapies were unknown. The patient had no drug reactions/allergies.  On 19-DEC-2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23)(lot # S021740, expiration date was 25-MAR-2021) intramuscularly (dose, frequency and anatomical location were not provided) and a influenza virus vaccine (dose, route, frequency, anatomical location, lot number and expiration date were not reported)for prophylaxis.   On 21-DEC-2019, the patient experienced erythema at the injection site. The outcome of the event was recovering. The causality between the event and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23)and influenza virus vaccine was not provided.
Age: 64.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Injected limb mobility decreased, Loss of personal independence in daily activities, Pain, Pain in extremity
Clinical narrative: PAinful Arm + Limited RAnge of Motion
Age: 64.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Joint range of motion decreased, Pain in extremity
Clinical narrative: PAinful Arm + Limited RAnge of Motion
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Blood culture negative, Bronchiolitis, C-reactive protein increased, CSF red blood cell count, CSF white blood cell count negative
Clinical narrative: Parent reported possible seizure activity and patient was transported to Hospital
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Chest X-ray abnormal, Computerised tomogram head normal, Culture urine negative, Electroencephalogram normal, Endotracheal intubation
Clinical narrative: Parent reported possible seizure activity and patient was transported to Hospital
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Enterovirus test negative, Full blood count normal, Herpes simplex test negative, Intensive care, Liver function test increased
Clinical narrative: Parent reported possible seizure activity and patient was transported to Hospital
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Lumbar puncture normal, Magnetic resonance imaging brain normal, Mental status changes, Metabolic function test normal, Pneumonia
Clinical narrative: Parent reported possible seizure activity and patient was transported to Hospital
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Polymerase chain reaction, Procalcitonin increased, Respiratory distress, Respiratory syncytial virus test positive, Respiratory viral panel
Clinical narrative: Parent reported possible seizure activity and patient was transported to Hospital
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Seizure, Status epilepticus, Urine analysis normal
Clinical narrative: Parent reported possible seizure activity and patient was transported to Hospital
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Seizure
Clinical narrative: Parent reported possible seizure activity and patient was transported to Hospital
Age: 13.0
Sex: M
Vaccine: HPVX, HPV9
Symptoms: Abnormal sensation in eye, Ear pain, Eyelid function disorder, Facial paralysis, Sinus pain
Clinical narrative: The day after vaccination, 1/3/20 had some right sided mouth pain, cough and congestion and a little right eye discomfort.  He took Zyrtec and allegra.  He had a nosebleed on the left side 1/4/20.  He was seen in clinic 1/6/20 and  told he likely had some sinus congestion as he was having some right facial pain. He was advised to use Flonase, mucinex and nasal saline rinses.  Friday 1/10/20 he started with right ear pain and 1/11/20 with right eye pain.  1/12/20 he was unable to smile on right side of face and couldn't blink his right eye.  He was seen in clinic 1/13/2020 and diagnosed with Bell's Palsy and started on prednisone and valacyclovir.
Age: 13.0
Sex: M
Vaccine: HPVX, HPV9
Symptoms: Toothache
Clinical narrative: The day after vaccination, 1/3/20 had some right sided mouth pain, cough and congestion and a little right eye discomfort.  He took Zyrtec and allegra.  He had a nosebleed on the left side 1/4/20.  He was seen in clinic 1/6/20 and  told he likely had some sinus congestion as he was having some right facial pain. He was advised to use Flonase, mucinex and nasal saline rinses.  Friday 1/10/20 he started with right ear pain and 1/11/20 with right eye pain.  1/12/20 he was unable to smile on right side of face and couldn't blink his right eye.  He was seen in clinic 1/13/2020 and diagnosed with Bell's Palsy and started on prednisone and valacyclovir.
Age: 13.0
Sex: M
Vaccine: HPVX, HPV9
Symptoms: Cough, Ear pain, Epistaxis, Eye pain, Eyelid function disorder
Clinical narrative: The day after vaccination, 1/3/20 had some right sided mouth pain, cough and congestion and a little right eye discomfort.  He took Zyrtec and allegra.  He had a nosebleed on the left side 1/4/20.  He was seen in clinic 1/6/20 and  told he likely had some sinus congestion as he was having some right facial pain. He was advised to use Flonase, mucinex and nasal saline rinses.  Friday 1/10/20 he started with right ear pain and 1/11/20 with right eye pain.  1/12/20 he was unable to smile on right side of face and couldn't blink his right eye.  He was seen in clinic 1/13/2020 and diagnosed with Bell's Palsy and started on prednisone and valacyclovir.
Age: 13.0
Sex: M
Vaccine: HPVX, HPV9
Symptoms: Facial pain, Facial paralysis, Ocular discomfort, Oral pain, Respiratory tract congestion
Clinical narrative: The day after vaccination, 1/3/20 had some right sided mouth pain, cough and congestion and a little right eye discomfort.  He took Zyrtec and allegra.  He had a nosebleed on the left side 1/4/20.  He was seen in clinic 1/6/20 and  told he likely had some sinus congestion as he was having some right facial pain. He was advised to use Flonase, mucinex and nasal saline rinses.  Friday 1/10/20 he started with right ear pain and 1/11/20 with right eye pain.  1/12/20 he was unable to smile on right side of face and couldn't blink his right eye.  He was seen in clinic 1/13/2020 and diagnosed with Bell's Palsy and started on prednisone and valacyclovir.
Age: 13.0
Sex: M
Vaccine: HPVX, HPV9
Symptoms: Sinus congestion
Clinical narrative: The day after vaccination, 1/3/20 had some right sided mouth pain, cough and congestion and a little right eye discomfort.  He took Zyrtec and allegra.  He had a nosebleed on the left side 1/4/20.  He was seen in clinic 1/6/20 and  told he likely had some sinus congestion as he was having some right facial pain. He was advised to use Flonase, mucinex and nasal saline rinses.  Friday 1/10/20 he started with right ear pain and 1/11/20 with right eye pain.  1/12/20 he was unable to smile on right side of face and couldn't blink his right eye.  He was seen in clinic 1/13/2020 and diagnosed with Bell's Palsy and started on prednisone and valacyclovir.
Age: 39.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Fatigue, Mass, Pain, Pruritus
Clinical narrative: Started to itch really bad after the shot and severe pain increased as the day went on, that night there was a huge red lump the size of a golf ball felt size and had body aches and have extreme fatigue, each day the lump and redness has increased to now the size of a salad plate, pain and itching has increased as well, even with cold compress, taking ibuff, Tylenol and antihistamines.
Age: 0.75
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional adverse effect; the patient was inadvertently administered the third dose of ROTATEQ at age 36 week; This spontaneous report was received from a nurse referring to a 36-weeks-old patient of unknown gender. Information about patient's pertinent concurrent conditions, medical history, concomitant medications and previous drug reactions or allergies were not reported.  On 08-JAN-2020, the patient was inadvertently vaccinated with the third dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), orally as prophylaxis (concentration, vaccination scheme frequency were not reported; lot number S000945 has been verified to be a valid, expiration date reported and validated as 13-JUL-2020) at age 36 weeks (inappropriate schedule of product administration).  No additional adverse effects were reported.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered
Clinical narrative: The patient received an expired dose of VARIVAX; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. No information regarding the patient's medical history or concurrent conditions was provided. Concomitant therapies included sterile diluent (manufacturer unknown).     On 10-JAN-2020, the patient was vaccinated with expired dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # N027628, expiration date on 04-OCT-2019 (strength, dose number, anatomical location and route not provided) for prophylaxis.
Sex: F
Vaccine: VARZOS
Symptoms: Immune thrombocytopenic purpura, Increased tendency to bruise, Rash
Clinical narrative: Patient suffered rashes on her legs accompanied by easy bruising whereafter she was hospitalized and diagnosed with severe idiopathic thrombocytopenic purpura.; Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication.  On 07-JUL-2016, the patient was inoculated with a dose of zoster vaccine live (ZOSTAVAX) (lot number, expiration date, dosage and route of administration not provided), for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster).  Shortly after receiving the zoster vaccine live (ZOSTAVAX), the patient suffered rashes on her legs accompanied by easy bruising whereafter she was hospitalized on unspecified dates and diagnosed with severe idiopathic thrombocytopenic purpura.  As a direct and proximate result of the zoster vaccine live (ZOSTAVAX) vaccine, the patient's symptoms have resulted in physical limitations not present prior to using the vaccine. Patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. The outcome of the idiopathic thrombocytopenic purpura was unknown.The reporter considered the vaccination with zoster vaccine live (ZOSTAVAX) to be related to the idiopathic thrombocytopenic purpura. Upon internal review the idiopathic thrombocytopenic purpura was consider as medically significant event.
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Ear pain, Headache, Occipital neuralgia, Trigeminal neuralgia
Clinical narrative: trigeminal and occipital neuralgia; trigeminal and occipital neuralgia; Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication.   On 29-OCT-2014 the patient was vaccinated with zoster vaccine live(ZOSTAVAX) (dose, route, lot# and expiration date were unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster)(for prophylaxis). Shortly after receiving inoculation, the patient suffered sharp stabbing pain in the back of his lower head, left ear, and left upper quadrant and was diagnosed with trigeminal and occipital neuralgia.  As a direct and proximate result of patient's use of the zoster vaccine live(ZOSTAVAX) vaccine, patient symptoms have resulted in physical limitations not present prior to using zoster vaccine live(ZOSTAVAX). Patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live(ZOSTAVAX), patient sustained severe and permanent personal injuries. further, as a tragic consequence of wrongful conduct, patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury.
Age: 21.0
Sex: F
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: no adverse effect; inadvertently administered a dose of Proquad and Varivax on same day; inadvertently administered a dose of Proquad and Varivax on same day; This spontaneous report was received from a nurse referring to a 21-year-old female patient. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. On 15-JAN-2020, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) (dose, dosing schedule, route of administration were not reported) lot # S019462 with expiration date 24-JUN-2021 and Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (dose, dosing schedule, route of administration were not reported) lot # S012536 with expiration date 20-OCT-2020 for prophylaxis. On 15-JAN-2020, the patient experienced overdose, inappropriate schedule of vaccine administered. No adverse symptoms reported. The outcome of the events were unknown. The causality assessment between the events and suspect therapy were not reported.
Age: 8.0
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration
Clinical narrative: They had their first two doses of Gardasil 9 vaccine in October and December 2015. The third dose was dur in April 2016 but this has not yet been administered; This spontaneous information has been received from a consumer, concerning a 13-year-old female patient. The patient's medical history, concurrent conditions, previously drug reactions, allergies and concomitant medications were not provided.  On 19-OCT-2015, the patient was vaccinated with her first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for prophylaxis (strength, route of administration, anatomical location, lot number and expiration date were not reported). On 22-DEC-2015, the patient received her second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for prophylaxis (strength, route of administration, anatomical location, lot number and expiration date were not reported).  On April 2016, the patient was scheduled to receive her third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) however it was not administered at the time of this report (inappropriate schedule of product administration).  This is one of two reports from the same source.; Sender's Comments:  US-009507513-2001USA006582:
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Expired M-M-R II dose was administered; This spontaneous report was received from a certified medical assistant refers to a patient of an unknown age and gender. The patient's pertinent medical history, concomitant medication and drug reactions or allergies were not reported.  On 16-JAN-2020, the patient was vaccinated with one expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), therapy type: recombinant human albumin (rHA), lot # N025894 (expired date: 19-SEP-2019), for prophylaxis (strength, anatomical location and route were not reported). The patient did not experience any adverse events. No product quality complaint (PQC) was involved.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: the patient was administered a dose of VARIVAX on 1/4/2020, that had been improperly stored; This spontaneous report was received from the vaccine coordinator, referring to a patient of unknown age an gender. The patient's concurrent conditions, past medical history and concomitant medications were not reported.  On 04-JAN-2020, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot # S021926 and expiration date: 15-JUL-2021 (dose, frequency, route and anatomical location were not provided) for prophylaxis. The administered dose of the vaccine was stored with the temperature of 1.2 degrees centigrades for 3 hours and 9 minutes. There was a digital data logger involved, but there was no previous temperature excursion. The vaccine was reconstituted with a properly stored sterile diluent. No additional adverse events reported.
Sex: U
Vaccine: VARCEL
Symptoms: Contraindication to vaccination
Clinical narrative: a patient, who has AIDS, received a dose of VARIVAX on 1/16/2020. Physician reported the patient had a "CD4 count of 159" prior to receiving dose of VARIVAX.; This spontaneous report was received from a physician referring to a patient of unknown age and gender. Concurrent condition included acquired immune deficiency syndrome (AIDS). Information about medical history, drug reaction/allergy and concomitant medication was not provided.       On an unknown date prior to receiving dose of varicella virus vaccine live (oka/merck) (VARIVAX), the patient's cluster of differentiation 4 (CD4) count was 159 (unit not provided). On 16-JAN-2020, the patient who had AIDS was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) (lot # S005084, expiration date not reported, but upon internal validation established as 19-FEB-2021; strength, vaccine dosage detail and route of administration were not reported) for prophylaxis (product use in unapproved population).    The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT. The outcome of the event was unknown.