chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 26.0
Sex: F
Vaccine: FLUN4
Symptoms: Asthenia, Dizziness, Nausea
Clinical narrative: Today I received the VAERS mist. I got very weak, dizzy, and nauseous just a few minutes after walking out to the parking-lot. I was lucky because I had my husband there to drive my baby and I home. These symptoms were strong for about ten minutes. It was about an hour after the vaccination. I was able to eat something. I still feel a bit dizzy but I am sure I will be fine. Is this how I will always react to the VAERS mist vaccination. Will it get worse the next time?
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Pyrexia
Clinical narrative: Patient reports having a low grade fever around 99.6 degrees and severe chills.  Recommended Tylenol for treatment.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Dysphagia, Hypersensitivity, Malaise, Pharyngeal oedema, Throat irritation
Clinical narrative: Patient reported to her husband (MD) that she was having difficulty swallowing and her throat was scratchy and swelling closed. Her husband left night duty and came home. Gave pt Benadryl. Pt reported to MD where it was determined she had suffered an allergic reaction to the vaccination. Pt reported to pharmacy today to let us know of reaction and reported feeling better but still not feeling well.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Vaccination complication
Clinical narrative: Patient reported to her husband (MD) that she was having difficulty swallowing and her throat was scratchy and swelling closed. Her husband left night duty and came home. Gave pt Benadryl. Pt reported to MD where it was determined she had suffered an allergic reaction to the vaccination. Pt reported to pharmacy today to let us know of reaction and reported feeling better but still not feeling well.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Local swelling
Clinical narrative: Swelling of arm, took 25 mg of Benadryl and subsided.
Age: 11.0
Sex: F
Vaccine: FLU4, HPV4, TDAP
Symptoms: Immediate post-injection reaction, Syncope
Clinical narrative: Brief syncope immediately at administration of HPV vaccine.  Recovered immediately, observed for extended period of time and recovered fully back to baseline.
Age: 22.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Chills, Headache, Pain, Pyrexia
Clinical narrative: Severe body aches, back ache, head ache that night, the next day had 100.3 fever, chills, severe body aches and backache.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Deafness, Ear discomfort
Clinical narrative: Experienced a sensation of ears feeling plugged and some hearing loss.  Hearing affected and unresolved 2 days later.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Chest pain, Hypoaesthesia, Hypoaesthesia oral, Muscle spasms
Clinical narrative: Severe muscle cramp with pain across back and through chest into right arm, down into hand (fingers tingly/numb, also lips) lasting several minutes.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity, Paraesthesia, Paraesthesia oral
Clinical narrative: Severe muscle cramp with pain across back and through chest into right arm, down into hand (fingers tingly/numb, also lips) lasting several minutes.
Age: 80.0
Sex: F
Vaccine: FLUC3, PPV
Symptoms: Contusion, Erythema, Local swelling, Pain in extremity
Clinical narrative: Redness, swelling, pain and bruisng of the left arm. Patient took Tylenol and Benadryl.
Age: 45.0
Sex: M
Vaccine: FLUX
Symptoms: Chills, Diarrhoea, Hyperhidrosis
Clinical narrative: Diarrhea, sweats, chills.
Age: 42.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Chills, Headache, Myalgia, Pain
Clinical narrative: Severe, painful chills, headache, muscle aches, low grade fever, weakness, generalized pain, paleness.
Age: 42.0
Sex: F
Vaccine: FLUX
Symptoms: Pallor, Pyrexia
Clinical narrative: Severe, painful chills, headache, muscle aches, low grade fever, weakness, generalized pain, paleness.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Mobility decreased, Pain
Clinical narrative: Pt states vaccine hurt immediately and still hurts 2 days later. Pt states she is unable to lift her arm over her head.
Age: 3.0
Sex: M
Vaccine: DTAPHEPBIP, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Erythema, Injection site rash, Injection site vesicles, Rash
Clinical narrative: About 1 minute after vaccines were administered mother c/o redness and rash to face. Monitored patient for 15 minutes and rash appeared to subside. Instructed mother to follow up with PCP or ER. Mother called back today and stated he had blistered rash on rt leg. Physician did not think is was vaccine related. Instructed mother to call us with any further questions.
Age: 5.0
Sex: M
Vaccine: RV5, RV5
Symptoms: Exposure during pregnancy, Rash, Skin irritation, Wrong drug administered
Clinical narrative: Pt. came for vaccine. Was given Rotavirus. Needed IPV - mom said pt has rash on legs is irritable. She is 20 wks pregnant.
Age: 5.0
Sex: M
Vaccine: RV5, RV5
Symptoms: Irritability, Rash, Wrong drug administered
Clinical narrative: Pt. came for vaccine. Was given Rotavirus. Needed IPV - mom said pt has rash on legs is irritable. She is 20 wks pregnant.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Haemorrhage subcutaneous, Local swelling, Pruritus, Skin warm
Clinical narrative: 2 days after vaccine administration left arm swelling, itching, 5 cm very red, warm area with SQ hemorrhage evident.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Local swelling
Clinical narrative: Swelling on left arm. Swollen area is red and 1/4" enlarged. Size is 3" x 2" in oval shape.
Age: 11.0
Sex: M
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: Rash on chest and face and neck advised patient take BENADRYL and call MD if symptoms got worse or do not improve.
Age: 51.0
Sex: M
Vaccine: FLU3
Symptoms: Abdominal pain upper, Chills, Diarrhoea, Headache, Pain
Clinical narrative: Pt. calls clinic c/o H/A, mm-aches, fever, chills throughout night approximately then at 12 noon 10/9/13 - pt states he has had stomach pain and diarrhea. 430pm not feeling better re: fever/chills, no more diarrhea.
Age: 51.0
Sex: M
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: Pt. calls clinic c/o H/A, mm-aches, fever, chills throughout night approximately then at 12 noon 10/9/13 - pt states he has had stomach pain and diarrhea. 430pm not feeling better re: fever/chills, no more diarrhea.
Age: 0.34
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Rash papular
Clinical narrative: Pt was given her 4 month routine vaccines. Together with her twin sister. Pt had a mild reaction her ankles and calves with erythematous papulae. Scattered. No urticarial lesions. No resp distress. Pt was smiling and happy. Mild papular rash reaction had resolved within 30 minutes.
Age: 57.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Local swelling
Clinical narrative: Patient described arm swelling not in the injection site but below it.
Age: 0.51
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Injection site reaction, Rash papular
Clinical narrative: Acute -onset red 1-2 mm papular rash diffusely spreading from upper thighs to GU to lower abdomen. Given 1 mg/kg benadryl.
Age: 53.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Local swelling
Clinical narrative: Patient described arm swelling not in the injection site but below it.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Malaise, Vomiting
Clinical narrative: Vaccine administered at approx. 10h30AM. Call from daughter at approx. 4h10PM reporting patient vomiting and unwell. Patient referred to MD or hospital ER.
Age: 59.0
Sex: F
Vaccine: FLU3, HEPAB, PPV
Symptoms: Influenza like illness, Injection site erythema, Injection site swelling, Injection site warmth, Pain
Clinical narrative: Redness/warmth/swelling at the site. Flu like sxs, body aches, fever. Got AUGMENTIN from NP.
Age: 59.0
Sex: F
Vaccine: FLU3, HEPAB, PPV
Symptoms: Pyrexia
Clinical narrative: Redness/warmth/swelling at the site. Flu like sxs, body aches, fever. Got AUGMENTIN from NP.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV, VARZOS
Symptoms: Feeling hot, Injection site pain, Pruritus
Clinical narrative: Pt received vaccine Sunday. Pt said slept all day Monday, came in called us Tuesday, said feels hot and itchy. Site was clear on all vaccines. Pt received Flu, Pneumonia on right arm separated, left arm received Zostavax. Pt. described pain in Flu/Pneumonia only on 1st day, 3rd day was taking Benadryl for itching. No hives just itching. Today is 4th day much better.
Age: 78.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Induration, Local swelling, Pain in extremity
Clinical narrative: Patient returned to pharmacy complaining arm felt swollen from shoulder to elbow. He says his arm area felt hard and sore. Physician notified. Dr. says common adverse, follow up Friday with MD if not better.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Oral discomfort, Pigmentation lip, Pruritus
Clinical narrative: Lips feeling tight, itching, burning sensation like pepper feeling. (24 hrs later felt like this). Also dark spots on lips. Not yet going to ER.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Pyrexia, Vomiting
Clinical narrative: Patient's mom came to report patient's conditions. Patient has bad diarrhea, vomiting and fever.
Age: 46.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema
Clinical narrative: Reddened area 4.5 cm width by 9.0 cm length at just inferior to injection site.
Age: 22.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Feeling hot, Nodule, Pyrexia
Clinical narrative: Red, knot in arm, felt hot about 10 pm night of vaccination -> next morning increased in symptoms and felt feverish. Hasn't taken any OTC meds.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU3, MMR
Symptoms: Injection site erythema, Injection site vesicles
Clinical narrative: Lt thigh has inoculation reaction with about 10 cm red base with multiple (6) vesicles with clear fluid. Varivax given at site 2 days prior.
Age: 18.0
Sex: F
Vaccine: FLU3
Symptoms: Syncope
Clinical narrative: Patient was cleared to receive AFLURIA-trivalent flu vaccine after questioning and consent. The IM shot was given in the left deltoid with no event. Then seconds after the Band-Aid was applied she fainted.
Age: 63.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Rash erythematous, Skin discolouration
Clinical narrative: 2 days post vaccine (Zostavax) patient states she has a raised bump on her left buttock. States it has a black dot in center and is about the size of a dime. Not sure if it was itchy. Went to medical officer. Rx for Acyclovir - provider was unsure if bump was shingles.
Age: 28.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Abscess, Induration, Mass, Pain, Secretion discharge
Clinical narrative: Pain, hard lump (abscess) swelling, drainage - Tdap.
Age: 28.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Swelling
Clinical narrative: Pain, hard lump (abscess) swelling, drainage - Tdap.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Rash generalised, Swelling face
Clinical narrative: Patient had severe swelling around face and rash on body approximatley 2 days after vaccine given. Pt. treated with prednisone. Swelling has improved with steroid tx.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Tremor
Clinical narrative: Severe shaking chills for 4-5 hrs the evening after the High dose flu injection.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a patient of unknown age and gender. On unknown date the patient was vaccinated with a dose of M-M-R II, injection, (lot # J002502, expiration date 28-FEB-2015). There was no concomitant medication reported. The nurse practitioner reported that the vaccine was exposed to a highest temperature of 11.5 degree centigrade for 21.5 hours. No adverse effect reported. This is one of several reports received from same source. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Bedridden, Headache, Pain
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 22 year old female patient. The patient has no pertinent medical history or drug reactions/allergies. On 30-SEP-2013 the patient was vaccinated with GARDASIL 120 Y (dose 1; route, dosage and lot number unknown). No concomitant medication was reported. The pharmacist reported that on 03-OCT-2013 patient developed a headache. The pharmacist said the patient felt like his spine was shooting out of his head. The patient was bedridden with pain. The patient sought medical attention by contacting the pharmacist and received treatment with ibuprofen and naproxen. The patient was reported as not recovered from the events. Upon internal review the events were considered as disabling as the patient was bedridden. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Activities of daily living impaired, Asthenia, Blood pressure immeasurable, Dizziness, Electroencephalogram normal
Clinical narrative: Information has been received from the authors in a published literature article, concerning a healthy 15-year-old female developed new onset dizziness and headache 4 weeks after receiving the first injection with HPV vaccine. In the following 2 months she began to experience syncope and presyncope, along with dizziness, shaking, muscle twitching, hyperventilation and generalized weakness. Nuclear magnetic resonance imaging (MRI) of the brain and magnetic resonance angiography of the head and neck, as well as Electroencephalogram (EEG), were unremarkable. A tilt table test demonstrated an increase in heart rate from 75 bpm supine to 112 bpm within 1 min of tilt without orthostatic hypotension. After 7 min of tilt, the heart rate decreased to 60 bpm with an unobtainable blood pressure, at which time the patient became unresponsive. She regained consciousness and her vital signs stabilized on assuming a supine position. The tilt table test was consistent with Postural orthostatic tachycardia syndrome (POTS) and neurocardiogenic syncope (NCS). With pharmacotherapy consisting of a selective serotonin reuptake inhibitor (sertraline), which can be helpful in patients with POTS and NCS, her symptoms improved but persisted over the following 2 years. She was able to attend school 4 hours per day with pre-syncope occurring between one and four times per month. The reporter stated that nevertheless, none of the patients experienced complete resolution of symptoms, and all patients continued to experience some residual symptoms. Possible pathogenesis of the new onset POTS after vaccination may include the mechanism of molecular mimicry, whereas Human papillomavirus (HPV) vaccine epitopes may induce formation of cross-reacting antibodies against potential targets of the autonomic ganglia, neurons, cardiac proteins or 31 /2-adrenergic and M2/3 muscarinic receptors. Additionally, induction of bystander lymphocyte activation and a broad spectrum of cytokine responses elicited by the HPV vaccine may also be involved. The reporter stated that the temporal association between vaccination with GARDASIL and the onset of symptoms of POTS in healthy young women is significant and deserves further investigation for assessment of a possible causal relationship. Upon internal review patient became unresponsive. She regained consciousness and her vital signs stabilized was considered medically significant. This is one of several reports from the same literature article: 1310USA000643, 1007USA02012, 1310USA003785, 1310USA003799, 1310USA003819. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Heart rate increased, Hyperventilation, Muscle twitching, Nuclear magnetic resonance imaging brain normal
Clinical narrative: Information has been received from the authors in a published literature article, concerning a healthy 15-year-old female developed new onset dizziness and headache 4 weeks after receiving the first injection with HPV vaccine. In the following 2 months she began to experience syncope and presyncope, along with dizziness, shaking, muscle twitching, hyperventilation and generalized weakness. Nuclear magnetic resonance imaging (MRI) of the brain and magnetic resonance angiography of the head and neck, as well as Electroencephalogram (EEG), were unremarkable. A tilt table test demonstrated an increase in heart rate from 75 bpm supine to 112 bpm within 1 min of tilt without orthostatic hypotension. After 7 min of tilt, the heart rate decreased to 60 bpm with an unobtainable blood pressure, at which time the patient became unresponsive. She regained consciousness and her vital signs stabilized on assuming a supine position. The tilt table test was consistent with Postural orthostatic tachycardia syndrome (POTS) and neurocardiogenic syncope (NCS). With pharmacotherapy consisting of a selective serotonin reuptake inhibitor (sertraline), which can be helpful in patients with POTS and NCS, her symptoms improved but persisted over the following 2 years. She was able to attend school 4 hours per day with pre-syncope occurring between one and four times per month. The reporter stated that nevertheless, none of the patients experienced complete resolution of symptoms, and all patients continued to experience some residual symptoms. Possible pathogenesis of the new onset POTS after vaccination may include the mechanism of molecular mimicry, whereas Human papillomavirus (HPV) vaccine epitopes may induce formation of cross-reacting antibodies against potential targets of the autonomic ganglia, neurons, cardiac proteins or 31 /2-adrenergic and M2/3 muscarinic receptors. Additionally, induction of bystander lymphocyte activation and a broad spectrum of cytokine responses elicited by the HPV vaccine may also be involved. The reporter stated that the temporal association between vaccination with GARDASIL and the onset of symptoms of POTS in healthy young women is significant and deserves further investigation for assessment of a possible causal relationship. Upon internal review patient became unresponsive. She regained consciousness and her vital signs stabilized was considered medically significant. This is one of several reports from the same literature article: 1310USA000643, 1007USA02012, 1310USA003785, 1310USA003799, 1310USA003819. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Postural orthostatic tachycardia syndrome, Presyncope, Syncope, Tilt table test positive, Tremor
Clinical narrative: Information has been received from the authors in a published literature article, concerning a healthy 15-year-old female developed new onset dizziness and headache 4 weeks after receiving the first injection with HPV vaccine. In the following 2 months she began to experience syncope and presyncope, along with dizziness, shaking, muscle twitching, hyperventilation and generalized weakness. Nuclear magnetic resonance imaging (MRI) of the brain and magnetic resonance angiography of the head and neck, as well as Electroencephalogram (EEG), were unremarkable. A tilt table test demonstrated an increase in heart rate from 75 bpm supine to 112 bpm within 1 min of tilt without orthostatic hypotension. After 7 min of tilt, the heart rate decreased to 60 bpm with an unobtainable blood pressure, at which time the patient became unresponsive. She regained consciousness and her vital signs stabilized on assuming a supine position. The tilt table test was consistent with Postural orthostatic tachycardia syndrome (POTS) and neurocardiogenic syncope (NCS). With pharmacotherapy consisting of a selective serotonin reuptake inhibitor (sertraline), which can be helpful in patients with POTS and NCS, her symptoms improved but persisted over the following 2 years. She was able to attend school 4 hours per day with pre-syncope occurring between one and four times per month. The reporter stated that nevertheless, none of the patients experienced complete resolution of symptoms, and all patients continued to experience some residual symptoms. Possible pathogenesis of the new onset POTS after vaccination may include the mechanism of molecular mimicry, whereas Human papillomavirus (HPV) vaccine epitopes may induce formation of cross-reacting antibodies against potential targets of the autonomic ganglia, neurons, cardiac proteins or 31 /2-adrenergic and M2/3 muscarinic receptors. Additionally, induction of bystander lymphocyte activation and a broad spectrum of cytokine responses elicited by the HPV vaccine may also be involved. The reporter stated that the temporal association between vaccination with GARDASIL and the onset of symptoms of POTS in healthy young women is significant and deserves further investigation for assessment of a possible causal relationship. Upon internal review patient became unresponsive. She regained consciousness and her vital signs stabilized was considered medically significant. This is one of several reports from the same literature article: 1310USA000643, 1007USA02012, 1310USA003785, 1310USA003799, 1310USA003819. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Unresponsive to stimuli
Clinical narrative: Information has been received from the authors in a published literature article, concerning a healthy 15-year-old female developed new onset dizziness and headache 4 weeks after receiving the first injection with HPV vaccine. In the following 2 months she began to experience syncope and presyncope, along with dizziness, shaking, muscle twitching, hyperventilation and generalized weakness. Nuclear magnetic resonance imaging (MRI) of the brain and magnetic resonance angiography of the head and neck, as well as Electroencephalogram (EEG), were unremarkable. A tilt table test demonstrated an increase in heart rate from 75 bpm supine to 112 bpm within 1 min of tilt without orthostatic hypotension. After 7 min of tilt, the heart rate decreased to 60 bpm with an unobtainable blood pressure, at which time the patient became unresponsive. She regained consciousness and her vital signs stabilized on assuming a supine position. The tilt table test was consistent with Postural orthostatic tachycardia syndrome (POTS) and neurocardiogenic syncope (NCS). With pharmacotherapy consisting of a selective serotonin reuptake inhibitor (sertraline), which can be helpful in patients with POTS and NCS, her symptoms improved but persisted over the following 2 years. She was able to attend school 4 hours per day with pre-syncope occurring between one and four times per month. The reporter stated that nevertheless, none of the patients experienced complete resolution of symptoms, and all patients continued to experience some residual symptoms. Possible pathogenesis of the new onset POTS after vaccination may include the mechanism of molecular mimicry, whereas Human papillomavirus (HPV) vaccine epitopes may induce formation of cross-reacting antibodies against potential targets of the autonomic ganglia, neurons, cardiac proteins or 31 /2-adrenergic and M2/3 muscarinic receptors. Additionally, induction of bystander lymphocyte activation and a broad spectrum of cytokine responses elicited by the HPV vaccine may also be involved. The reporter stated that the temporal association between vaccination with GARDASIL and the onset of symptoms of POTS in healthy young women is significant and deserves further investigation for assessment of a possible causal relationship. Upon internal review patient became unresponsive. She regained consciousness and her vital signs stabilized was considered medically significant. This is one of several reports from the same literature article: 1310USA000643, 1007USA02012, 1310USA003785, 1310USA003799, 1310USA003819. Additional information has been requested.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to approximately 10 unspecified patients. On an unknown date, the patients were vaccinated with approximately 10 doses of PROQUAD (Merck) (Lot # reported as H015785, expiration date 24-FEB-2014 and lot # reported as J00432, expiration date 17-OCT-2014) and VARIVAX (Merck) (Lot # reported as J003532, expiration date 25-MAR-2015) that were exposed to -4C for 720 hours (30 days) which was not supported. No adverse effects were reported. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Dyspnoea, Electrocardiogram ambulatory abnormal, Electroencephalogram normal, Loss of consciousness
Clinical narrative: Information has been received from the authors in a published literature article, concerning an 12-year-old previously healthy female. Six days after a receiving a second dose of GARDASIL vaccine, the patient began experiencing episodic loss of consciousness, which after neurological and cardiac evaluation was determined to be secondary to neurocardiogenic syncope (NCS). Holter monitor demonstrated a heart rate range from 44 bpm to 212 bpm with the patient reporting shortness of breath and palpitations at the time of sinus tachycardia occurring with exertion. Orthostatic blood pressure and heart rate assessment demonstrated a supine heart rate of 65 bpm and a maximum heart rate of 122 bpm without orthostatic hypotension during a 5 min standing test, which was consistent with Postural orthostatic tachycardia syndrome (POTS); a tilt table test was not obtained. The patient's symptoms improved significantly with the use of fludrocortisone and high sodium diet for volume expansion, and she was able to attend school full-time and play sports. Subsequently, she received a third dose of GARDASIL vaccine, and 3 weeks after vaccination her symptoms of dizziness and episodes of loss of consciousness intensified. After a second MRI of the brain and 24-h video EEG at the epilepsy monitoring unit revealed no abnormalities, the etiology of the episodes was determined to be once again secondary to NCS. The course of her symptoms over the following 12 months after the third GARDASIL appeared to be relapsing and remitting, with several syncope-free months followed by recurrence of syncope. Three years after the onset of syncope, the patient's daily symptoms have mostly resolved, and she experiences syncope only occasionally. The patient improved over 3 years. The reporter stated that nevertheless, none of the patients experienced complete resolution of symptoms, and all patients continued to experience some residual symptoms. Possible pathogenesis of the new onset POTS after vaccination may include the mechanism of molecular mimicry, whereas Human papillomavirus (HPV) vaccine epitopes may induce formation of cross-reacting antibodies against potential targets of the autonomic ganglia, neurons, cardiac proteins or 31 /2-adrenergic and M2/3 muscarinic receptors. Additionally, induction of bystander lymphocyte activation and a broad spectrum of cytokine responses elicited by the HPV vaccine may also be involved. The reporter stated that The temporal association between vaccination with GARDASIL and the onset of symptoms of POTS in healthy young women is significant and deserves further investigation for assessment of a possible causal relationship. Upon internal review loss of consciousness was determined to be once again secondary to NCS was considered medically significant. This is one of several reports from the same literature article: 1310USA000643, 1007USA02012, 1310USA003785, 1310USA003813, 1310USA003819. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Nuclear magnetic resonance imaging brain normal, Palpitations, Postural orthostatic tachycardia syndrome, Sinus tachycardia, Syncope
Clinical narrative: Information has been received from the authors in a published literature article, concerning an 12-year-old previously healthy female. Six days after a receiving a second dose of GARDASIL vaccine, the patient began experiencing episodic loss of consciousness, which after neurological and cardiac evaluation was determined to be secondary to neurocardiogenic syncope (NCS). Holter monitor demonstrated a heart rate range from 44 bpm to 212 bpm with the patient reporting shortness of breath and palpitations at the time of sinus tachycardia occurring with exertion. Orthostatic blood pressure and heart rate assessment demonstrated a supine heart rate of 65 bpm and a maximum heart rate of 122 bpm without orthostatic hypotension during a 5 min standing test, which was consistent with Postural orthostatic tachycardia syndrome (POTS); a tilt table test was not obtained. The patient's symptoms improved significantly with the use of fludrocortisone and high sodium diet for volume expansion, and she was able to attend school full-time and play sports. Subsequently, she received a third dose of GARDASIL vaccine, and 3 weeks after vaccination her symptoms of dizziness and episodes of loss of consciousness intensified. After a second MRI of the brain and 24-h video EEG at the epilepsy monitoring unit revealed no abnormalities, the etiology of the episodes was determined to be once again secondary to NCS. The course of her symptoms over the following 12 months after the third GARDASIL appeared to be relapsing and remitting, with several syncope-free months followed by recurrence of syncope. Three years after the onset of syncope, the patient's daily symptoms have mostly resolved, and she experiences syncope only occasionally. The patient improved over 3 years. The reporter stated that nevertheless, none of the patients experienced complete resolution of symptoms, and all patients continued to experience some residual symptoms. Possible pathogenesis of the new onset POTS after vaccination may include the mechanism of molecular mimicry, whereas Human papillomavirus (HPV) vaccine epitopes may induce formation of cross-reacting antibodies against potential targets of the autonomic ganglia, neurons, cardiac proteins or 31 /2-adrenergic and M2/3 muscarinic receptors. Additionally, induction of bystander lymphocyte activation and a broad spectrum of cytokine responses elicited by the HPV vaccine may also be involved. The reporter stated that The temporal association between vaccination with GARDASIL and the onset of symptoms of POTS in healthy young women is significant and deserves further investigation for assessment of a possible causal relationship. Upon internal review loss of consciousness was determined to be once again secondary to NCS was considered medically significant. This is one of several reports from the same literature article: 1310USA000643, 1007USA02012, 1310USA003785, 1310USA003813, 1310USA003819. Additional information has been requested.
Age: 45.0
Sex: F
Vaccine: PPV
Symptoms: C-reactive protein, Erythema, Full blood count, Local reaction, Local swelling
Clinical narrative: This spontaneous report was received from a registered nurse concerning an approximately 45 year old female patient. Current conditions of the patient included with lupus, sulfa allergy (gastrointestinal upset) and shellfish allergy (unspecified). The medical history of the patient included prior pneumonia. On 01-OCT-2013, the patient was vaccinated with 0.5 milliliter (ml) of PNEUMOVAX23 (lot number and expiry date were reported as J005011 and 04-DEC-2014 respectively), intramuscularly. Concomitant therapies included PLAQUENIL, omega-3 marine triglycerides (reproted as fish oil), vitamin D (unspecified), levothyroxine sodium and omeprazole. On 01-OCT-2013, the patient experienced localized reaction that was red, swollen, and painful upper arm that spread to the shoulder, right clavicle and neck after receiving PNEUMOVAX23. The patient sought medical attention (called). The patient was advised to go to an emergency room. An unspecified antibiotic was given as a treatment. On an unknown date, C-reactive protein test and complete blood count (CBC) test were performed and the results were unknown. The outcome of all the events was unknown. The relatedness for all the events was unknown for receiving PNEUMOVAX23. Additional information has been requested.
Age: 45.0
Sex: F
Vaccine: PPV
Symptoms: Neck pain, Pain in extremity
Clinical narrative: This spontaneous report was received from a registered nurse concerning an approximately 45 year old female patient. Current conditions of the patient included with lupus, sulfa allergy (gastrointestinal upset) and shellfish allergy (unspecified). The medical history of the patient included prior pneumonia. On 01-OCT-2013, the patient was vaccinated with 0.5 milliliter (ml) of PNEUMOVAX23 (lot number and expiry date were reported as J005011 and 04-DEC-2014 respectively), intramuscularly. Concomitant therapies included PLAQUENIL, omega-3 marine triglycerides (reproted as fish oil), vitamin D (unspecified), levothyroxine sodium and omeprazole. On 01-OCT-2013, the patient experienced localized reaction that was red, swollen, and painful upper arm that spread to the shoulder, right clavicle and neck after receiving PNEUMOVAX23. The patient sought medical attention (called). The patient was advised to go to an emergency room. An unspecified antibiotic was given as a treatment. On an unknown date, C-reactive protein test and complete blood count (CBC) test were performed and the results were unknown. The outcome of all the events was unknown. The relatedness for all the events was unknown for receiving PNEUMOVAX23. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a patient of unknown age and gender. On unknown date the patient was vaccinated with a dose of M-M-R II, injection, (lot # J002502, expiration date 28-FEB-2015). There was no concomitant medication reported. The nurse practitioner reported that the vaccine was exposed to a highest temperature of 11.5 degree centigrade for 16.5 hours. No adverse effect reported. This is one of several reports received from same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report as received from a nurse practitioner vial a company representative refers to an unspecified number of patients of unknown ages and genders. On unknown dates the patients were vaccinated with ZOSTAVAX, 0.65 ml one dose, subcutaneous (SQ) (lot# and expiration date not reported). On unknown dates the unspecified patients had developed redness and swelling at the injection site after receiving a ZOSTAVAX vaccination. The patients sought medical attention and reported to the office. The action taken with therapy was unknown. The outcome of the events was unknown. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a registered nurse concerning a female patient of unknown age. The medical history of the patient included a case of shingles before the vaccination at an unspecified time. On an unknown date in 2009, the patient was vaccinated with ZOSTAVAX (lot number, expiry date, dose and route unspecified). No concomitant therapy was reported. Approximately on an unknown date in September 2013 (reported as this past week), the patient was diagnosed with shingles. She sought medical attention (the patient informed the nurse by phone on 02-OCT-2013). No treatment was given and no lab te4sts were performed. The outcome of shingles was reported as not resolved. The relatedness for shingles was unknown for ZOSTAVAX. Additional information has been requested.
Age: 27.0
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy, Full blood count, Laboratory test, Pregnancy test positive, Viral load
Clinical narrative: This spontaneous prospective pregnancy report was received from a licensed vocational nurse (the call was originally placed by her husband) refers to a female patient of unknown age with no pertinent medical history and drug reactions or allergies. On 10-SEP-2013 the patient was vaccinated with 0.5 milliliters (ml) VARIVAX (Merck) (lot#, expiration date not reported), subcutaneously. Concomitant therapies included prenatal vitamins. The nurse reported that she became pregnant "within two weeks" (approximately on an unknown date in September 2013) of receiving VARIVAX (Merck). She stated that she found out she was pregnant by a home pregnancy test on 28-SEP-2013. She reported that she was seen by her physician on 01-OCT-2013 and a viral load was drawn as well as a titer on that day. She also reported that on 04-OCT-2013 she had a "full panel of lab tests drawn including a CBC." Patient sought medical attention for the event. Additional information has been requested.
Age: 27.0
Sex: F
Vaccine: VARCEL
Symptoms: Viral titre
Clinical narrative: This spontaneous prospective pregnancy report was received from a licensed vocational nurse (the call was originally placed by her husband) refers to a female patient of unknown age with no pertinent medical history and drug reactions or allergies. On 10-SEP-2013 the patient was vaccinated with 0.5 milliliters (ml) VARIVAX (Merck) (lot#, expiration date not reported), subcutaneously. Concomitant therapies included prenatal vitamins. The nurse reported that she became pregnant "within two weeks" (approximately on an unknown date in September 2013) of receiving VARIVAX (Merck). She stated that she found out she was pregnant by a home pregnancy test on 28-SEP-2013. She reported that she was seen by her physician on 01-OCT-2013 and a viral load was drawn as well as a titer on that day. She also reported that on 04-OCT-2013 she had a "full panel of lab tests drawn including a CBC." Patient sought medical attention for the event. Additional information has been requested.
Age: 76.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Pruritus, Rash
Clinical narrative: This spontaneous report was received from a doctor of pharmacy concerning an approximately 76 year old female patient with no pertinent medical history and with no drug reactions or allergies. On 02-OCT-2013, the patient was vaccinated with 0.65 milliliter (ml) of ZOSTAVAX (lot number and expiry date were reported as J001697 and 08-MAY-2014 respectively), subcutaneously. There were no concomitant medications. On 02-OCT-2013, the patient experienced breaking out, red and itching on her arm and abdomen after receiving ZOSTAVAX. The patient sought medical attention (called pharmacist). The patient was treated with BENADRYL. No lab tests were performed. The outcome of breaking out, red and itching on her arm and abdomen was unknown. The relatedness for breaking out, red and itching on her arm and abdomen was unknown for ZOSTAVAX. Additional information has been requested.
Age: 76.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Aphonia, Dysphagia, Lip swelling, Rash generalised
Clinical narrative: This spontaneous report was received from a doctor of pharmacy concerning an approximately 76 year old female patient with no pertinent medical history and with no drug reactions or allergies. On 02-OCT-2013, the patient was vaccinated with 0.65 milliliter (ml) of ZOSTAVAX (lot number and expiry date were reported as J001697 and 08-MAY-2014 respectively), subcutaneously. There were no concomitant medications. On 02-OCT-2013, the patient experienced breaking out, red and itching on her arm and abdomen after receiving ZOSTAVAX. The patient sought medical attention (called pharmacist). The patient was treated with BENADRYL. No lab tests were performed. The outcome of breaking out, red and itching on her arm and abdomen was unknown. The relatedness for breaking out, red and itching on her arm and abdomen was unknown for ZOSTAVAX. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with a dose of M-M-R II, injection, (lot # J002502, expiration date 28-FEB-2015). There was no concomitant medication reported. The nurse practitioner reported that the vaccine was exposed to a highest temperature of 11.5 degree centigrade for 10.5 hours. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Staphylococcal infection
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. The patient's relevant medical history, and past drug history were unknown. On 20-SEP-2013 the patient was vaccinated with one dose of ZOSTAVAX (lot number reported as J003799, expiration date 28-JUN-2014) (strength and dose were not reported). Concomitant medications were not reported. On 21-SEP-2013, the patient experienced  nasal Staphylococcal infection and was prescribed with CIPRO at an unknown dose. It was unknown if there was any relevant laboratory data. Patient continued experiencing the nasal Staphylococcal infection. The relationship between ZOSTAVAX and the Staphylococcal infection was not reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a patient of unknown age and gender. On unknown date the patient was vaccinated with a dose of M-M-R II, injection, (lot # J002502, expiration date 28-FEB-2015). There was no concomitant medication reported. The nurse practitioner reported that the vaccine was exposed to a highest temperature of 11.5 degree centigrade for 22.5 hours. No adverse effect reported. This is one of several reports received from same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a patient of unknown age and gender. On unknown date the patient was vaccinated with a dose of M-M-R-II, injection (lot # J002502, expiration date 28-FEB-2015). There was no concomitant medication reported. The nurse practitioner reported that the vaccine was exposed to a highest temperature of 11.5 degree centigrade for 22.5 hours. No adverse effect reported. This is one of several reports from same source. Additional information has been requested.
Age: 10.0
Sex: M
Vaccine: HEPA, HEPA
Symptoms: Anaphylactic reaction
Clinical narrative: This case was reported by a consumer (mother of subject) and described the occurrence of general unwell feeling in a 10-year-old male subject who was vaccinated with HAVRIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. On 1 June 2013 the subject received a dose of HAVRIX (unknown details, left arm). On 1 June 2013, 10 minutes after vaccination with HAVRIX, the subject experienced general unwell feeling, pallor and gasping. Per the mother of the subject, about 10 minutes after the injection, the subject began to not feel well. The subject then had a "whitish/gray appearance". The subject began gasping, and could not breathe very well. The mother noted that "it was difficult to breathe from the throat area and not asthma-like." The mother sought medical attention for the subject at the clinic. The subject was treated with EPIPEN. The EPIPEN "did not work" so "another EPIPEN was given, at a stronger dose." The subject improved. The mother did not wish to provide much detail on this report. At the time of reporting the events were resolved. Follow up was received from a healthcare professional (nurse) via sales representative on 3 October 2013. This case is now medically confirmed. The healthcare professional reported on 10 or 11 year old male that experienced anaphylaxis after receiving HAVRIX vaccination. Follow up was received from the nurse on 4 October 2013. The nurse documented the lot and expiry of the HAVRIX 720 that was administered to the child. The nurse was inquiring about the ingredients in HAVRIX. No further information was provided.
Age: 10.0
Sex: M
Vaccine: HEPA, HEPA
Symptoms: Anaphylactic reaction, Dyspnoea, Malaise, Pallor, Skin discolouration
Clinical narrative: This case was reported by a consumer (mother of subject) and described the occurrence of general unwell feeling in a 10-year-old male subject who was vaccinated with HAVRIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. On 1 June 2013 the subject received a dose of HAVRIX (unknown details, left arm). On 1 June 2013, 10 minutes after vaccination with HAVRIX, the subject experienced general unwell feeling, pallor and gasping. Per the mother of the subject, about 10 minutes after the injection, the subject began to not feel well. The subject then had a "whitish/gray appearance". The subject began gasping, and could not breathe very well. The mother noted that "it was difficult to breathe from the throat area and not asthma-like." The mother sought medical attention for the subject at the clinic. The subject was treated with EPIPEN. The EPIPEN "did not work" so "another EPIPEN was given, at a stronger dose." The subject improved. The mother did not wish to provide much detail on this report. At the time of reporting the events were resolved. Follow up was received from a healthcare professional (nurse) via sales representative on 3 October 2013. This case is now medically confirmed. The healthcare professional reported on 10 or 11 year old male that experienced anaphylaxis after receiving HAVRIX vaccination. Follow up was received from the nurse on 4 October 2013. The nurse documented the lot and expiry of the HAVRIX 720 that was administered to the child. The nurse was inquiring about the ingredients in HAVRIX. No further information was provided.
Age: 41.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Rash
Clinical narrative: Rash on neck 45 min after immunization BENADRYL 25 mg oral liquid given per FNP patient observed for 45 min - no c/o SOB, wheezing -phoned pt at 3:30 pm, pt stated rash is better. 8-21-13 pt. phoned - stated "rash all over" - per Dr. advised to continue BENADRYL. 9-03-13 phoned pt. stated rash resolved after 4 days.
Age: 41.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Rash generalised
Clinical narrative: Rash on neck 45 min after immunization BENADRYL 25 mg oral liquid given per FNP patient observed for 45 min - no c/o SOB, wheezing -phoned pt at 3:30 pm, pt stated rash is better. 8-21-13 pt. phoned - stated "rash all over" - per Dr. advised to continue BENADRYL. 9-03-13 phoned pt. stated rash resolved after 4 days.
Age: 49.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Blood blister, Petechiae
Clinical narrative: Initial report was received from a healthcare professional on 27 September 2013. A 49-year-old male patient had received a dose one intradermal injection in the left deltoid of FLUZONE INTRADERMAL, lot number UT4719BA, on 24 September 2013 and one day later on 25 September 2013 the patient experienced blood blisters in mouth and petechiae on his body. As of the time of the report, the symptoms were improving. Treatments were not reported. The patient had no illness at the time of vaccination and no past medical history. Outcome was not recovered. Documents held by sender: None.
Age: 49.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Blood blister, Oral mucosal blistering, Petechiae
Clinical narrative: Initial report was received from a healthcare professional on 27 September 2013. A 49-year-old male patient had received a dose one intradermal injection in the left deltoid of FLUZONE INTRADERMAL, lot number UT4719BA, on 24 September 2013 and one day later on 25 September 2013 the patient experienced blood blisters in mouth and petechiae on his body. As of the time of the report, the symptoms were improving. Treatments were not reported. The patient had no illness at the time of vaccination and no past medical history. Outcome was not recovered. Documents held by sender: None.
Age: 1.01
Sex: F
Vaccine: HEPA, MMR, VARCEL, HEPA, HIBV, MMR, PPV, VARCEL
Symptoms: Herpes zoster
Clinical narrative: Herpes zoster diagnosis in a 2 dose varicella vaccine recipient. Rash on chest and back. Lasted less than two weeks.
Age: 1.01
Sex: F
Vaccine: HEPA, MMR, VARCEL, HEPA, HIBV, MMR, PPV, VARCEL
Symptoms: Herpes zoster, Rash
Clinical narrative: Herpes zoster diagnosis in a 2 dose varicella vaccine recipient. Rash on chest and back. Lasted less than two weeks.