chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 17.0
Sex: F
Vaccine: FLU3, MNQ
Symptoms: Immediate post-injection reaction, Syncope
Clinical narrative: The client fainted 20-30 seconds after receiving the immunizations.
Age: 0.58
Sex: M
Vaccine: PNC13
Symptoms: Discomfort, Injection site erythema, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: Reaction started around 5:30pm.  Right thigh became red around injection site. By 6:00pm entire thigh down to the knee was bright red, hot to the touch, skin was tight, swollen, and baby screamed when leg was touched. Baby was screaming due to discomfort. Tylenol was administered around 6:30pm and bath was given with lavender soap used to help inflammation. Baby was in bath for around 30 minutes mostly to help baby calm down as he enjoys baths. By 8:30 leg wasn?t as red but was still warm to the touch. By the next morning leg was no longer red at all but lower right thigh near knee is still warmer than the left leg. Tylenol is still being used as baby still seems to be in some discomfort. Baby never had a fever during this. No vomiting. Appetite has seemed normal.
Age: 0.58
Sex: M
Vaccine: PNC13
Symptoms: Screaming, Skin tightness
Clinical narrative: Reaction started around 5:30pm.  Right thigh became red around injection site. By 6:00pm entire thigh down to the knee was bright red, hot to the touch, skin was tight, swollen, and baby screamed when leg was touched. Baby was screaming due to discomfort. Tylenol was administered around 6:30pm and bath was given with lavender soap used to help inflammation. Baby was in bath for around 30 minutes mostly to help baby calm down as he enjoys baths. By 8:30 leg wasn?t as red but was still warm to the touch. By the next morning leg was no longer red at all but lower right thigh near knee is still warmer than the left leg. Tylenol is still being used as baby still seems to be in some discomfort. Baby never had a fever during this. No vomiting. Appetite has seemed normal.
Age: 1.25
Sex: M
Vaccine: DTAPIPVHIB, MMR, PNC15, VARCEL
Symptoms: Erythema, Injection site rash
Clinical narrative: Vaccines given, rash developed on both thighs, Chest and arms red. Zyrtec given PO, nurse & MD monitored. Rash improved and patient sent home.
Age: 0.17
Sex: M
Vaccine: DTPPVHBHPB, PNC20, RV5
Symptoms: Enema administration, Haematochezia, Intussusception, Ultrasound abdomen abnormal, Vomiting
Clinical narrative: Patient developed vomiting followed by bloody stools. It was initially thought to be milk protein allergy but the vomiting progressed over the course of the day and patient presented to an emergency department. He was transferred to the hospital  ED where an ultrasound diagnosed intussusception. This was reduced using pneumatic insufflation on 12/18/2024 and the patient was admitted to the hospital for observation. After 8 hours of observation, he was eating well with no further vomiting and discharged home on 12/18/2024.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Joint swelling, Pain
Clinical narrative: left sided shoulder pain and swelling that has been persistent and now interfering with lifting left shoulder without significant pain
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Electrocardiogram normal, Palpitations
Clinical narrative: heart palpitations, on and off, now for about a week since 12/12/24. Minor and no other symptoms
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Neck pain, Pain in extremity, Pyrexia
Clinical narrative: pt says she started having pain in her right shoulder. She continues to have pain in her right shoulder and  through her neck muscle to her base of her neck. She had a mild fever for 2 days which she no longer has but continues to have the pain in her arm and neck. She was applying heat and ice packs but it was not helping. She is using Motrin which seems to help with the pain some.
Age: 66.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Pt received seasonal flushot twice. first dose on 9/17/2024 and the second on 12/17/2024. pt had no adverse reactions to either.
Age: 16.0
Sex: F
Vaccine: COVID19, FLU3, MENB, MNQ
Symptoms: Syncope
Clinical narrative: Syncope,  collapsed to floor. She regained consciousness immediately, no complaint of pain or injury.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: A 15-year -old patient inadvertently received a dose of 0.25 ml covid-19 Moderna 6m-11y vaccine instead of 0.5ml Moderna Spikevax .
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Erythema, Nausea, Pain
Clinical narrative: Large local reaction (red, swollen, warm, nonpruritic) beginning approximately 36 hours post vaccination. A few hours late , I developed a fever, which peaked at 101.2 and was accompanied by severe chills. Local reaction had increased 48 hours post vaccination with reduced fever of 99.3. Weakness, body aches, and nausea. Note: I have had all available COVID vaccinations with no side effects.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Skin warm, Swelling
Clinical narrative: Large local reaction (red, swollen, warm, nonpruritic) beginning approximately 36 hours post vaccination. A few hours late , I developed a fever, which peaked at 101.2 and was accompanied by severe chills. Local reaction had increased 48 hours post vaccination with reduced fever of 99.3. Weakness, body aches, and nausea. Note: I have had all available COVID vaccinations with no side effects.
Age: 17.0
Sex: F
Vaccine: UNK
Symptoms: Underdose
Clinical narrative: A 17-year -old patient inadvertently received a dose of 0.25 ml covid-19 Moderna 6m-11y vaccine instead of 0.5ml Moderna Spikevax .
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Product storage error
Clinical narrative: Vaccine administered after storage outside recommended parameters
Age: 50.0
Sex: M
Vaccine: FLU3
Symptoms: Product storage error
Clinical narrative: Vaccine administered after storage outside recommended parameters
Age: 32.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain upper, Arthralgia, Cardiac monitoring, Chest pain, Condition aggravated
Clinical narrative: pt states he started having a severe miagraine, body aches, pain in his joints, running fever, and his was nauseated. He was having heart palatations. These symptoms lasted for a couple of days. He went back to doing normal activites when his heart started racing. He felt like his heart was firing off. His pulse was well over 150 beats per minute. After this episode its just went back to normal. So he just started taking it easy so he wouldn't have any more episodes. Now he continues to notice his acid reflux is getting more severe. He now has respiratory issues where he never had any issues prior to the vaccine. He now has sleep issues. He feels like he is having a paralizing pain in his chest like a shock is going through it. He had a sleep apnea test and a heart monitor that he wore for a month. His heart rate was down to 33 bpm. When he wakes up its racing. He had this happening about 40 times during the past few years but he no longer is waking up with this, but still feels like there is something dead inside his chest like it is paralyzed, like it is numb. It hard to describe. He has shocks to his heart that come and go. He has pain in his stomach that come and goes. He has a feeling of nerve damage or paralyisis. He continues to have the miagraines, body aches, pain in the joints, and feeling of being nauseaded that still to this day just come and go. He is not being treated by a Pulmonologist, Cardiologist, GI, and referred to an ENT specialist.
Age: 32.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Electric shock sensation, Gastrooesophageal reflux disease, Heart rate increased, Hypoaesthesia, Migraine
Clinical narrative: pt states he started having a severe miagraine, body aches, pain in his joints, running fever, and his was nauseated. He was having heart palatations. These symptoms lasted for a couple of days. He went back to doing normal activites when his heart started racing. He felt like his heart was firing off. His pulse was well over 150 beats per minute. After this episode its just went back to normal. So he just started taking it easy so he wouldn't have any more episodes. Now he continues to notice his acid reflux is getting more severe. He now has respiratory issues where he never had any issues prior to the vaccine. He now has sleep issues. He feels like he is having a paralizing pain in his chest like a shock is going through it. He had a sleep apnea test and a heart monitor that he wore for a month. His heart rate was down to 33 bpm. When he wakes up its racing. He had this happening about 40 times during the past few years but he no longer is waking up with this, but still feels like there is something dead inside his chest like it is paralyzed, like it is numb. It hard to describe. He has shocks to his heart that come and go. He has pain in his stomach that come and goes. He has a feeling of nerve damage or paralyisis. He continues to have the miagraines, body aches, pain in the joints, and feeling of being nauseaded that still to this day just come and go. He is not being treated by a Pulmonologist, Cardiologist, GI, and referred to an ENT specialist.
Age: 32.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Nausea, Neurological symptom, Pain, Palpitations, Pyrexia
Clinical narrative: pt states he started having a severe miagraine, body aches, pain in his joints, running fever, and his was nauseated. He was having heart palatations. These symptoms lasted for a couple of days. He went back to doing normal activites when his heart started racing. He felt like his heart was firing off. His pulse was well over 150 beats per minute. After this episode its just went back to normal. So he just started taking it easy so he wouldn't have any more episodes. Now he continues to notice his acid reflux is getting more severe. He now has respiratory issues where he never had any issues prior to the vaccine. He now has sleep issues. He feels like he is having a paralizing pain in his chest like a shock is going through it. He had a sleep apnea test and a heart monitor that he wore for a month. His heart rate was down to 33 bpm. When he wakes up its racing. He had this happening about 40 times during the past few years but he no longer is waking up with this, but still feels like there is something dead inside his chest like it is paralyzed, like it is numb. It hard to describe. He has shocks to his heart that come and go. He has pain in his stomach that come and goes. He has a feeling of nerve damage or paralyisis. He continues to have the miagraines, body aches, pain in the joints, and feeling of being nauseaded that still to this day just come and go. He is not being treated by a Pulmonologist, Cardiologist, GI, and referred to an ENT specialist.
Age: 32.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Respiratory disorder, Sleep disorder, Sleep study
Clinical narrative: pt states he started having a severe miagraine, body aches, pain in his joints, running fever, and his was nauseated. He was having heart palatations. These symptoms lasted for a couple of days. He went back to doing normal activites when his heart started racing. He felt like his heart was firing off. His pulse was well over 150 beats per minute. After this episode its just went back to normal. So he just started taking it easy so he wouldn't have any more episodes. Now he continues to notice his acid reflux is getting more severe. He now has respiratory issues where he never had any issues prior to the vaccine. He now has sleep issues. He feels like he is having a paralizing pain in his chest like a shock is going through it. He had a sleep apnea test and a heart monitor that he wore for a month. His heart rate was down to 33 bpm. When he wakes up its racing. He had this happening about 40 times during the past few years but he no longer is waking up with this, but still feels like there is something dead inside his chest like it is paralyzed, like it is numb. It hard to describe. He has shocks to his heart that come and go. He has pain in his stomach that come and goes. He has a feeling of nerve damage or paralyisis. He continues to have the miagraines, body aches, pain in the joints, and feeling of being nauseaded that still to this day just come and go. He is not being treated by a Pulmonologist, Cardiologist, GI, and referred to an ENT specialist.
Age: 32.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain upper, Anxiety, Body temperature, Cardiac disorder, Cardiac monitoring
Clinical narrative: pt states he started having a severe miagraine, body aches, pain in his joints, running fever, and his was nauseated. He was having heart palatations. These symptoms lasted for a couple of days. He went back to doing normal activites when his heart started racing. He felt like his heart was firing off. His pulse was well over 150 beats per minute. After this episode its just went back to normal. So he just started taking it easy so he wouldn't have any more episodes. Now he continues to notice his acid reflux is getting more severe. He now has respiratory issues where he never had any issues prior to the vaccine. He now has sleep issues. He feels like he is having a paralizing pain in his chest like a shock is going through it. He had a sleep apnea test and a heart monitor that he wore for a month. His heart rate was down to 33 bpm. When he wakes up its racing. He had this happening about 40 times during the past few years but he no longer is waking up with this, but still feels like there is something dead inside his chest like it is paralyzed, like it is numb. It hard to describe. He has shocks to his heart that come and go. He has pain in his stomach that come and goes. He has a feeling of nerve damage or paralyisis. He continues to have the miagraines, body aches, pain in the joints, and feeling of being nauseaded that still to this day just come and go. He is not being treated by a Pulmonologist, Cardiologist, GI, and referred to an ENT specialist.
Age: 32.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cardiospasm, Chest pain, Dust allergy, Dyspnoea, Feeding disorder
Clinical narrative: pt states he started having a severe miagraine, body aches, pain in his joints, running fever, and his was nauseated. He was having heart palatations. These symptoms lasted for a couple of days. He went back to doing normal activites when his heart started racing. He felt like his heart was firing off. His pulse was well over 150 beats per minute. After this episode its just went back to normal. So he just started taking it easy so he wouldn't have any more episodes. Now he continues to notice his acid reflux is getting more severe. He now has respiratory issues where he never had any issues prior to the vaccine. He now has sleep issues. He feels like he is having a paralizing pain in his chest like a shock is going through it. He had a sleep apnea test and a heart monitor that he wore for a month. His heart rate was down to 33 bpm. When he wakes up its racing. He had this happening about 40 times during the past few years but he no longer is waking up with this, but still feels like there is something dead inside his chest like it is paralyzed, like it is numb. It hard to describe. He has shocks to his heart that come and go. He has pain in his stomach that come and goes. He has a feeling of nerve damage or paralyisis. He continues to have the miagraines, body aches, pain in the joints, and feeling of being nauseaded that still to this day just come and go. He is not being treated by a Pulmonologist, Cardiologist, GI, and referred to an ENT specialist.
Age: 32.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Gastrointestinal disorder, Gastrooesophageal reflux disease, Heart rate, Heart rate abnormal, Heart rate decreased
Clinical narrative: pt states he started having a severe miagraine, body aches, pain in his joints, running fever, and his was nauseated. He was having heart palatations. These symptoms lasted for a couple of days. He went back to doing normal activites when his heart started racing. He felt like his heart was firing off. His pulse was well over 150 beats per minute. After this episode its just went back to normal. So he just started taking it easy so he wouldn't have any more episodes. Now he continues to notice his acid reflux is getting more severe. He now has respiratory issues where he never had any issues prior to the vaccine. He now has sleep issues. He feels like he is having a paralizing pain in his chest like a shock is going through it. He had a sleep apnea test and a heart monitor that he wore for a month. His heart rate was down to 33 bpm. When he wakes up its racing. He had this happening about 40 times during the past few years but he no longer is waking up with this, but still feels like there is something dead inside his chest like it is paralyzed, like it is numb. It hard to describe. He has shocks to his heart that come and go. He has pain in his stomach that come and goes. He has a feeling of nerve damage or paralyisis. He continues to have the miagraines, body aches, pain in the joints, and feeling of being nauseaded that still to this day just come and go. He is not being treated by a Pulmonologist, Cardiologist, GI, and referred to an ENT specialist.
Age: 32.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Illness, Migraine, Myocardial infarction, Neuralgia, Pain
Clinical narrative: pt states he started having a severe miagraine, body aches, pain in his joints, running fever, and his was nauseated. He was having heart palatations. These symptoms lasted for a couple of days. He went back to doing normal activites when his heart started racing. He felt like his heart was firing off. His pulse was well over 150 beats per minute. After this episode its just went back to normal. So he just started taking it easy so he wouldn't have any more episodes. Now he continues to notice his acid reflux is getting more severe. He now has respiratory issues where he never had any issues prior to the vaccine. He now has sleep issues. He feels like he is having a paralizing pain in his chest like a shock is going through it. He had a sleep apnea test and a heart monitor that he wore for a month. His heart rate was down to 33 bpm. When he wakes up its racing. He had this happening about 40 times during the past few years but he no longer is waking up with this, but still feels like there is something dead inside his chest like it is paralyzed, like it is numb. It hard to describe. He has shocks to his heart that come and go. He has pain in his stomach that come and goes. He has a feeling of nerve damage or paralyisis. He continues to have the miagraines, body aches, pain in the joints, and feeling of being nauseaded that still to this day just come and go. He is not being treated by a Pulmonologist, Cardiologist, GI, and referred to an ENT specialist.
Age: 32.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Palpitations, Paralysis, Pyrexia, Sleep apnoea syndrome, Sleep disorder due to a general medical condition
Clinical narrative: pt states he started having a severe miagraine, body aches, pain in his joints, running fever, and his was nauseated. He was having heart palatations. These symptoms lasted for a couple of days. He went back to doing normal activites when his heart started racing. He felt like his heart was firing off. His pulse was well over 150 beats per minute. After this episode its just went back to normal. So he just started taking it easy so he wouldn't have any more episodes. Now he continues to notice his acid reflux is getting more severe. He now has respiratory issues where he never had any issues prior to the vaccine. He now has sleep issues. He feels like he is having a paralizing pain in his chest like a shock is going through it. He had a sleep apnea test and a heart monitor that he wore for a month. His heart rate was down to 33 bpm. When he wakes up its racing. He had this happening about 40 times during the past few years but he no longer is waking up with this, but still feels like there is something dead inside his chest like it is paralyzed, like it is numb. It hard to describe. He has shocks to his heart that come and go. He has pain in his stomach that come and goes. He has a feeling of nerve damage or paralyisis. He continues to have the miagraines, body aches, pain in the joints, and feeling of being nauseaded that still to this day just come and go. He is not being treated by a Pulmonologist, Cardiologist, GI, and referred to an ENT specialist.
Age: 32.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Tremor, Weight, Weight decreased
Clinical narrative: pt states he started having a severe miagraine, body aches, pain in his joints, running fever, and his was nauseated. He was having heart palatations. These symptoms lasted for a couple of days. He went back to doing normal activites when his heart started racing. He felt like his heart was firing off. His pulse was well over 150 beats per minute. After this episode its just went back to normal. So he just started taking it easy so he wouldn't have any more episodes. Now he continues to notice his acid reflux is getting more severe. He now has respiratory issues where he never had any issues prior to the vaccine. He now has sleep issues. He feels like he is having a paralizing pain in his chest like a shock is going through it. He had a sleep apnea test and a heart monitor that he wore for a month. His heart rate was down to 33 bpm. When he wakes up its racing. He had this happening about 40 times during the past few years but he no longer is waking up with this, but still feels like there is something dead inside his chest like it is paralyzed, like it is numb. It hard to describe. He has shocks to his heart that come and go. He has pain in his stomach that come and goes. He has a feeling of nerve damage or paralyisis. He continues to have the miagraines, body aches, pain in the joints, and feeling of being nauseaded that still to this day just come and go. He is not being treated by a Pulmonologist, Cardiologist, GI, and referred to an ENT specialist.
Age: 21.0
Sex: F
Vaccine: FLU3
Symptoms: Product storage error
Clinical narrative: Vaccine administered after storage outside recommended parameters
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Product storage error
Clinical narrative: Vaccine administered after storage outside recommended parameters
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Product storage error
Clinical narrative: Vaccine administered after storage outside recommended parameters
Age: 31.0
Sex: U
Vaccine: FLU3
Symptoms: Product storage error
Clinical narrative: Vaccine administered after storage outside recommended parameters
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Product storage error
Clinical narrative: Vaccine administered after storage outside recommended parameters
Age: 33.0
Sex: U
Vaccine: FLU3
Symptoms: Product storage error
Clinical narrative: Vaccine administered after storage outside recommended parameters
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Condition aggravated, Injected limb mobility decreased, Pain in extremity, Pyrexia
Clinical narrative: Significant pain and limited ROM in left arm since Tdap immunization given 5 days ago. She has had worsening chronic joint pain diffusely and low grade fever. She has also had an erythematous pruritic rash develop across her left arm.
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Rash, Rash erythematous, Rash pruritic
Clinical narrative: Significant pain and limited ROM in left arm since Tdap immunization given 5 days ago. She has had worsening chronic joint pain diffusely and low grade fever. She has also had an erythematous pruritic rash develop across her left arm.
Age: 50.0
Sex: M
Vaccine: FLU3
Symptoms: Product storage error
Clinical narrative: Vaccine administered after storage outside recommended parameters.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Product storage error
Clinical narrative: Vaccine administered after storage outside recommended parameters
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Product storage error
Clinical narrative: Vaccine administered after storage outside recommended parameters.
Age: 37.0
Sex: U
Vaccine: FLU3
Symptoms: Product storage error
Clinical narrative: Vaccine administered after storage outside recommended parameters.
Age: 27.0
Sex: U
Vaccine: FLU3
Symptoms: Product storage error
Clinical narrative: Vaccine administered after storage outside recommended parameters
Age: 28.0
Sex: U
Vaccine: FLU3
Symptoms: Product storage error
Clinical narrative: Vaccine administered after storage outside recommended parameters.
Age: 37.0
Sex: M
Vaccine: FLU3
Symptoms: Product storage error
Clinical narrative: Vaccine administered after storage outside recommended parameters.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Product storage error
Clinical narrative: Vaccine administered after storage outside recommended parameters.
Age: 35.0
Sex: M
Vaccine: FLU3
Symptoms: Product storage error
Clinical narrative: Vaccine administered after storage outside recommended parameters
Age: 33.0
Sex: U
Vaccine: FLU3
Symptoms: Product storage error
Clinical narrative: Vaccine administered after storage outside recommended parameters.
Age: 1.08
Sex: M
Vaccine: DTAP, HEPA, HIBV, MMRV
Symptoms: Unevaluable event
Clinical narrative: none known
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Product storage error
Clinical narrative: Vaccine administered after storage outside recommended parameters
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Product storage error
Clinical narrative: Vaccine administered after storage outside recommended parameters
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Product storage error
Clinical narrative: Vaccine administered after storage outside recommended parameters
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Product storage error
Clinical narrative: Vaccine administered after storage outside recommended parameters.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Product storage error
Clinical narrative: Vaccine administered after storage outside recommended parameters
Age: 22.0
Sex: F
Vaccine: FLU3
Symptoms: Product storage error
Clinical narrative: Vaccine administered after storage outside recommended parameters
Age: 70.0
Sex: M
Vaccine: HEPA
Symptoms: Aphasia, Injection site pain, Mental impairment, Pain
Clinical narrative: Patient walked into clinic concerns about pain at injection site that immediately felt throughout his entire body. He also described not being able to think and unable to speak to anyone.  He wanted to say Happy Holiday's to someone and was unable to. He said the feeling did go away but did not mention how long it took. Denied anaphylactic symptoms.
Age: 36.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Wrong product administered
Clinical narrative: Patient presented to clinic for influenza and varicella vaccine. Influenza vaccine was administered per standing order. Varicella vaccine was ordered but  Zoster vaccine was administered instead of varicella vaccine. The patient was made aware by RN, no SE are expected.  The patient is going to get titers instead of coming back for varicella at another time to see if she has immunity and therefore does not need the vaccine.
Age: 4.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Product storage error
Clinical narrative: COVID-19 vaccine was given after the Beyond Use Date (BUD)
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Brain fog, Dizziness, Dyspnoea, Electrocardiogram ambulatory, Lethargy
Clinical narrative: Syncope, shortness of breath, dizziness, brain fog, lethargic.  Had a Holter monitor for 2 weeks after an emergency trip to the ER. Was 100% fine before the shot. Suspecting POTS syndrome induced by the vaccine.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Postural orthostatic tachycardia syndrome, Syncope
Clinical narrative: Syncope, shortness of breath, dizziness, brain fog, lethargic.  Had a Holter monitor for 2 weeks after an emergency trip to the ER. Was 100% fine before the shot. Suspecting POTS syndrome induced by the vaccine.
Age: 50.0
Sex: F
Vaccine: PNC21, VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: 6 days after receiving Capvaxive and Shingrix, patient developed local redness, swelling and itching at injection sight. The area is between 1 and 2 inches in width and warm to the touch. At this time patient is managing symptoms with over the counter medications and is not planning on seeking medical attention unless symptoms become worse.
Age: 0.25
Sex: M
Vaccine: HEPA, MMRV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient is 3 months old and was given MMRV and Hep A by mistake. These vaccines are not intended for patients under 12 months of age.
Age: 4.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: COVID-19 vaccine given after Beyond Use Date
Age: 14.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Dizziness, Fall, Hyperhidrosis, Pallor
Clinical narrative: APPROXIMATLEY 10 MINS POST VACCINATION PATIENT EXPERIENCED DIZZINESS THAT CAUSED PATIENT TO FALL, PERSPIRATION, AND PALOR.  VITAL SIGNS STABLE.  PATIENT REMAINED ALERT AND ORIENTED.  SYMPTOMS IMPROVING WITHIN 10 MINUTES OF EVENT.
Age: 79.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Pt Received inappropriate duplicate dose of vaccine which should have only been a one-time single dose. Pt was notified of duplication and counseled to monitor for any adverse reactions. pt stated she was not experiencing any localized or systemic reactions, but would notify us if anything developed.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dizziness, Electrocardiogram, Heart rate increased, Immediate post-injection reaction
Clinical narrative: Immediately after initial covid shot, patient was seen by primary provider for pain in chest and rapid heart rate. Did not end up filing report due to concerns with backlash for filing. Patient continues to have daily instances for 5-15 minutes of rapid heart rate ranging from 100-175 BPM with chest pain and dizziness. Planning to follow up with provider after instance on 12/18/2024 when patient took BP at home and HR was ranging 131-171.
Age: 2.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: left leg pain and swelling started 1 hour post injection. Mom gave ibuprofen to help with pain. He had fever to 100 overnight following the injection.  He has been in pain. Left thigh swollen from groin to mid knee, red, hot to touch. Patient referred to Emergency department for evaluation. Bedside U/S performed in ED. Edema consistent with vaccine reaction per ED physician. Diagnosed arthus reaction.
Age: 2.0
Sex: M
Vaccine: FLU3
Symptoms: Type III immune complex mediated reaction, Ultrasound scan
Clinical narrative: left leg pain and swelling started 1 hour post injection. Mom gave ibuprofen to help with pain. He had fever to 100 overnight following the injection.  He has been in pain. Left thigh swollen from groin to mid knee, red, hot to touch. Patient referred to Emergency department for evaluation. Bedside U/S performed in ED. Edema consistent with vaccine reaction per ED physician. Diagnosed arthus reaction.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Bordetella test negative, Chest X-ray abnormal, Computerised tomogram thorax abnormal, Dyspnoea, Increased upper airway secretion
Clinical narrative: Multiple small blood clots in both lungs and treatment included admission to Hospital on 11/25/24, discharged on 11/27/2024. Anticoagulant (heparin) given and then went home on Eliquis. The day after the shot had most intense side effects, of any shot, all respiratory-- difficulty breathing, drainage in throat, no fever, no sore arm. Currently weaning off oxygen. Much improved.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Pulmonary embolism, Respiratory syncytial virus test negative, SARS-CoV-2 test negative
Clinical narrative: Multiple small blood clots in both lungs and treatment included admission to Hospital on 11/25/24, discharged on 11/27/2024. Anticoagulant (heparin) given and then went home on Eliquis. The day after the shot had most intense side effects, of any shot, all respiratory-- difficulty breathing, drainage in throat, no fever, no sore arm. Currently weaning off oxygen. Much improved.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Fatigue, Feeling hot, Headache, Hypoaesthesia
Clinical narrative: 20 minutes after vaccine given felt numbness in tongue, and face was numb and difficult to move. L arm red and swollen and hot. Headache and tiredness, Numbness lasted about 2hrs.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia oral, Mobility decreased, Peripheral swelling
Clinical narrative: 20 minutes after vaccine given felt numbness in tongue, and face was numb and difficult to move. L arm red and swollen and hot. Headache and tiredness, Numbness lasted about 2hrs.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure abnormal, Feeling jittery, Hypoaesthesia, Muscular weakness, Paraesthesia
Clinical narrative: pt says about 5 minutes after getting the vaccine his legs and his feet started going number and feet started tingling. His legs were feeling week and blood pressure was 180/100.  He contacted is doctors office but he had to leave a message and called the pharmacy where the vaccine was given.  By this time his blood pressure was back almost back to normal. This lasted about 30 minutes but he still feels jittery.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered, No adverse event
Clinical narrative: PATIENT HAS NO REACTIONS REPORTED, BUT STATED SHE RECEIVED TWO COVID VACCINES SHE WAS UNDER THE IMPRESSION THE ONE IN OCTOBER WAS A FLU SHOT BUT IT WAS A COVID SHOT. PATIENT DID NOT HAVE ANY SIDE EFFECTS OR COMPLIANTS AND CAME BY TODAY TO GET A FLU SHOT.
Age: 24.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Extra dose administered, No adverse event
Clinical narrative: no adverse event, 3rd dose given in error.
Age: 16.0
Sex: M
Vaccine: HEPA, HPV9, IPV, MMR, MNQ, TDAP, VARCEL
Symptoms: Hyperhidrosis, Pallor, Syncope
Clinical narrative: Vaccine administered at 1015. Patient had syncopal episode after receiving Hpv  vaccine. Patient pale and diaphoretic and immediately became responsive after 15 seconds. Patient able to make needs known and oriented x3. Patient laid down and legs elevated on pillow. Patient given crackers and Soda pop. Patient blood pressure 118/74. Patient rested for 30 minutes and reports feeling much better. Patient no longer pale or diaphoretic. Patient instructed to wait in lobby for additional 15 minutes for monitoring prior to discharge. Orthostatic vitals taken lying 107/65 Heart rate 56-58, sitting 107/65 heartrate 60, standing 106/69 heartrate 60. Supervisor present and assisted with monitoring child and educating mom. Dr notified.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness
Clinical narrative: Patient came to clinic fasting for lab and vaccine appointment. Patient had blood drawn and then given a Fluzone High Dose vaccine. Shortly after, patient complained of feeling dizzy. Since patient had been fasting, she was given granola bar and 2 bottles of water. She also ate a banana that she had brought from home. Her PCP, Dr came to assess her and at that time patient stated that she was feeling less dizzy. Patient was observed for an additional 20 minutes. Patient then reported no dizziness and was okayed to be discharged by her PCP.
Age: 1.75
Sex: M
Vaccine: HIBV
Symptoms: Product preparation error
Clinical narrative: ActHIB vaccine was mixed with a Merck manufacturer diluent instead of the Sanofi Pasteur diluent as indicated. Attempted to contact mother of patient, however no answer or voicemail box. Patient will need to receive the vaccination again.
Age: 42.0
Sex: F
Vaccine: MNQ
Symptoms: Erythema, Pain, Pain in extremity, Swelling
Clinical narrative: The patient had swollen area with redness for 2 days and then the pain subsided. The patient had extreme arm pain shooting down her whole arm. The patient was advised to see a Doctor for getting it evaluated for treatment.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Fall, Haematoma, Influenza like illness, Skin abrasion
Clinical narrative: Flu like symptoms so severe that patient fell and scraped her knee and sustained a hematoma
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram, Heart rate increased, Palpitations
Clinical narrative: was having palpitations, high heart rate, denied dizziness, chest pain, or shortness of breath, vital signs were taken BP was 136/82 pulse was 170 at 11:20am, at 11:39am 102, at 11:48am 97, at 11:49am 98
Age: 11.0
Sex: F
Vaccine: COVID19, FLUN3, HPV9, MNQ, TDAP
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No adverse event but gave the wrong Covid vaccine. Gave Covid 12+ instead of 6 months - 11 years.
Age: 56.0
Sex: M
Vaccine: FLU3
Symptoms: Central serous chorioretinopathy
Clinical narrative: Received Flulaval (Flu) and Spikevax (Covid booster) on 12/03/2024. Eye problems began on 12/08/2024. Optometrist diagnosed as Central Serous ChorioRetinopathy (CSCR) on 12/11/2024. I have no idea if this was related to the vaccines, but I just wanted to report as an FYI.
Sex: M
Vaccine: TDAP
Symptoms: Wrong product administered
Clinical narrative: when choosing the vaccine I accidently grab Tdap instead of Dtab.
Age: 32.0
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration
Clinical narrative: No additional AE; Patient received their first dose of GARDASIL 9 in 2019, and a second dose of GARDASIL 9 on 12NOV2024; This spontaneous report was received from technician and refers to a 32-year-old patient of unknown gender.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On an unknown date in 2019, the patient started therapy with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, (0.5 milliliter, exact dose, lot #, expiration date, route of administration and anatomical location were not provided) for prophylaxis. On 12-NOV-2024, the patient was vaccinated with second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, (0.5 milliliter, exact dose, lot #, expiration date, route of administration and anatomical location were not provided) for prophylaxis (Inappropriate schedule of vaccine administered).  Lot # is being requested and will be submitted if received.
Sex: M
Vaccine: PPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: has received an "extra dose" of pneumococcal vaccine. Caller stated the patient has had 3 doses of PNEUMOVAX 23 (per label re vaccination can be done to high risk patients); No additional AE; This spontaneous report was received from a pharmacist, concerning to a 71-year-old male.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with 3 doses of  pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection, administered for prophylaxis (strength, dose, lot #, expiry date, and route of administration were not provided). Due to lack of knowleadge if the patient was a high risk patient and since per label re vaccination can be done. (Extra dose administered). No additional adverse event (No adverse event).   This is one of 2 reportes received from the same reporter.; Sender's Comments:  US-009507513-2412USA005907:
Sex: U
Vaccine: RSV
Symptoms: Insomnia
Clinical narrative: Difficulties sleeping; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of difficulty sleeping in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced difficulty sleeping (Verbatim: Difficulties sleeping). The outcome of the difficulty sleeping was not reported.   It was unknown if the reporter considered the difficulty sleeping to be related to Arexvy.     It was unknown if the company considered the difficulty sleeping to be related to Arexvy.   Additional Information: GSK Receipt Date: 20-NOV-2024 The reporter reported that he/she had at the injection site, his/her left arm, left-side of neck, and left-rear shoulder plate. The patient had difficulties sleeping.
Sex: U
Vaccine: DTAPIPV
Symptoms: Inappropriate schedule of product administration
Clinical narrative: couple of instances where some of like the fifth dose of polio because they had an extra dose of polio and /or the fifth dose of DTAP; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate schedule of vaccine administered in an unspecified number of patients who received DTPa-IPV (Kinrix) for prophylaxis.   Previously administered products included Infanrix and Pediarix.   On an unknown date, the patient received Kinrix. On an unknown date, an unknown time after receiving Kinrix, the patient experienced inappropriate schedule of vaccine administered (Verbatim: couple of instances where some of like the fifth dose of polio because they had an extra dose of polio and /or the fifth dose of DTAP). The outcome of the inappropriate schedule of vaccine administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 18-NOV-2024 Two probable different patients involved but information was not available. The vaccine associated for both cases were Kinrix. The age interval of the patients were 4 to 6 years old. The Medical Assistant called to report the following that they had a couple of incidents recently at a couple of our clinics sites. So, on the recommendation, the dose and schedule, it said that they need to use for the fifth dose of the DTAP and the fourth dose of the IPV administration. So, they had a couple of instances where some of like the fifth dose of polio because they had an extra dose of polio and /or the fifth dose of DTAP or cases where they had not had all doses of the DTAP or Polio but they're in that age, in the range of 4 to 6, they were just curious if it was ok to administer this or if it is only if it had passed 3 to 4 doses, which led to inappropriate schedule of vaccine administered. The reporter did have another question. So, they saw for the fifth dose and previous doses had been Infanrix and Pediarix, they could use the vaccine if the previous doses were Pentacel. The reporter consented to follow up.
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: was accidentally administered an expired dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 2-year-old male patient who received HAV (Havrix) (batch number 9R5LC, expiry date 02-NOV-2024) for prophylaxis.   Previously administered products included Havrix (received first dose of Havrix on an unknown date).   On 18-NOV-2024, the patient received the 2nd dose of Havrix. On 18-NOV-2024, an unknown time after receiving Havrix, the patient experienced expired vaccine used (Verbatim: was accidentally administered an expired dose). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 19-NOV-2024 The nurse reported that the 2 year old male patient was accidentally administered an expired dose of Havrix which led to expired vaccine used. They requested medical information. The Vaccine Administration Facility was the same as Primary Reporter.
Age: 1.0
Sex: M
Vaccine: DTAP, DTAP, DTAPIPV
Symptoms: Inappropriate schedule of product administration, Product administered to patient of inappropriate age
Clinical narrative: 2 years old and he was given a vaccine today; 3 previous doses of dtap were administered; 2 years old and he was given a vaccine today; 2 years old and he was given a vaccine today; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 2-year-old male patient who received DTPa-IPV (Kinrix) (batch number 3RT93, expiry date 03-APR-2026) for prophylaxis.   Co-suspect products included DTPa (DTaP vaccine) for prophylaxis and DTPa (DTaP vaccine) for prophylaxis.   Previously administered products included Dtap (received first dose of Dtap on November 2022).   On 19-NOV-2024, the patient received the 1st dose of Kinrix. On 07-APR-2024, the patient received the 3rd dose of DTaP vaccine. On 03-APR-2024, the patient received the 2nd dose of DTaP vaccine. On 03-APR-2024, not applicable after receiving Kinrix and DTaP vaccine and an unknown time after receiving DTaP vaccine, the patient experienced inappropriate age at vaccine administration (Verbatim: 2 years old and he was given a vaccine today). On 07-APR-2024, the patient experienced inappropriate age at vaccine administration (Verbatim: 2 years old and he was given a vaccine today). On 19-NOV-2024, the patient experienced inappropriate age at vaccine administration (Verbatim: 2 years old and he was given a vaccine today) and inappropriate schedule of vaccine administered (Verbatim: 3 previous doses of dtap were administered). The outcome of the inappropriate age at vaccine administration, inappropriate schedule of vaccine administered, inappropriate age at vaccine administration and inappropriate age at vaccine administration were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 19-NOV-2024 The other health professional reported that they had a patient that was 2 years old and he was given a vaccine on the day of reporting, he was given Kinrix which led to inappropriate age ay vaccine administration. The other health professional reported that the 3 previous doses of dtap were administered which led to inappropriate schedule of vaccine administered and inappropriate age ay vaccine administration. This case was linked with US2021250219, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021250219:same reporter
Age: 19.0
Sex: F
Vaccine: HEPA
Symptoms: Underdose
Clinical narrative: a pediatric dose of Havrix was administered to an adult patient; Underdose; This non-serious case was reported by a nurse via call center representative and described the occurrence of adult use of a child product in a 19-year-old female patient who received HAV (Havrix pediatric) (batch number 22GP3, expiry date 11-SEP-2026) for prophylaxis.   On 14-NOV-2024, the patient received Havrix pediatric. On 14-NOV-2024, an unknown time after receiving Havrix pediatric, the patient experienced adult use of a child product (Verbatim: a pediatric dose of Havrix was administered to an adult patient) and underdose (Verbatim: Underdose). The outcome of the adult use of a child product and underdose were unknown.   Additional Information: GSK Receipt Date: 19-NOV-2024 The patient administered pediatric dose of Havrix to an adult patient, which led adult use of a child product and underdose. The reporter consented to follow up.