chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 7.0
Sex: M
Vaccine: FLUX, FLU4, FLU4
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Initial information received on 09-Jan-2019 regarding an unsolicited valid non-serious case received from an other healthcare professional. This case is linked to case 2019SA010203 (same reporter). This case involves a 7 years old male patient who experienced reaction to right thigh complaining of redness, swelling and was hot to touch and the area was 8 x 12, while he received vaccine FLUZONE QUADRIVALENT. The patient's past medical history included allergic to Penicillin and Amoxicillin but not to eggs. The patient's past vaccination(s) included 7 flu shots. The patient's past medical treatment(s) and family history were not provided. On 31-Dec-2018, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UJ087AA, expiry date- 30-Jun-2019 via intramuscular route in the right thigh. On an unknown date, the patient developed a non-serious reaction to right thigh complaining of redness, swelling and was hot to touch and the area was 8 x 12 and vaccination site reaction (Unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE. This was reported on 02-Jan-2019. (Other relevant tests included No lab data reported). Final diagnosis was reaction to right thigh complaining of redness, swelling and was hot to touch and the area was 8 x 12. The patient was treated with HYDROCORTISONE. The patient outcome is reported as Unknown for reaction to right thigh complaining of redness, swelling and was hot to touch and the area was 8 x 12.
Age: 7.0
Sex: M
Vaccine: FLUX, FLU4, FLU4
Symptoms: Erythema, Local reaction, Pruritus, Swelling
Clinical narrative: Initial information received on 09-Jan-2019 regarding an unsolicited valid non-serious case received from an other healthcare professional. This case is linked to case 2019SA010203 (same reporter). This case involves a 7 years old male patient who experienced reaction to right thigh complaining of redness, swelling and was hot to touch and the area was 8 x 12, while he received vaccine FLUZONE QUADRIVALENT. The patient's past medical history included allergic to Penicillin and Amoxicillin but not to eggs. The patient's past vaccination(s) included 7 flu shots. The patient's past medical treatment(s) and family history were not provided. On 31-Dec-2018, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UJ087AA, expiry date- 30-Jun-2019 via intramuscular route in the right thigh. On an unknown date, the patient developed a non-serious reaction to right thigh complaining of redness, swelling and was hot to touch and the area was 8 x 12 and vaccination site reaction (Unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE. This was reported on 02-Jan-2019. (Other relevant tests included No lab data reported). Final diagnosis was reaction to right thigh complaining of redness, swelling and was hot to touch and the area was 8 x 12. The patient was treated with HYDROCORTISONE. The patient outcome is reported as Unknown for reaction to right thigh complaining of redness, swelling and was hot to touch and the area was 8 x 12.
Age: 7.0
Sex: M
Vaccine: FLUX, FLU4, FLU4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Initial information received on 09-Jan-2019 regarding an unsolicited valid non-serious case received from an other healthcare professional. This case is linked to case 2019SA010203 (same reporter). This case involves a 7 years old male patient who experienced reaction to right thigh complaining of redness, swelling and was hot to touch and the area was 8 x 12, while he received vaccine FLUZONE QUADRIVALENT. The patient's past medical history included allergic to Penicillin and Amoxicillin but not to eggs. The patient's past vaccination(s) included 7 flu shots. The patient's past medical treatment(s) and family history were not provided. On 31-Dec-2018, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UJ087AA, expiry date- 30-Jun-2019 via intramuscular route in the right thigh. On an unknown date, the patient developed a non-serious reaction to right thigh complaining of redness, swelling and was hot to touch and the area was 8 x 12 and vaccination site reaction (Unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE. This was reported on 02-Jan-2019. (Other relevant tests included No lab data reported). Final diagnosis was reaction to right thigh complaining of redness, swelling and was hot to touch and the area was 8 x 12. The patient was treated with HYDROCORTISONE. The patient outcome is reported as Unknown for reaction to right thigh complaining of redness, swelling and was hot to touch and the area was 8 x 12.
Age: 29.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL
Symptoms: Dizziness, Electrocardiogram T wave amplitude decreased, Electrocardiogram abnormal, Myocardial necrosis marker increased, Palpitations
Clinical narrative: Patient ran marathon 6 days post-SPV, and after completing his marathon he was sick for approximately 2 weeks with diffuse myalgia, dyspnea and HR well above 100 bpm for a week straight -> syncope. 7 Jan 2019, PCM  CC: "irregular heart beats" irregular heart beat started 2 weeks after receiving the smallpox vaccination (24 Dec 2018). heart feels as if it occasionally skips a beat and is then followed up by a large beatfeels lightheaded when working outoccasionally his heart is beating harder than normal. Runs 3 miles w/o symptoms. No chest pain, dyspnea. 8 Jan 2019, Adm H&P:  syncopal episode w/ increasing palpitationspalpitations started around  time he finished marathon 4 weeks ago (16 Dec, PVD 6) After notification of abnormal labs on 7 Jan, felt anxious w/ brief ~5-10 sec of left sided sharp mid axillary chest pain. While at dinner, pt felt little dizzy/light headed with diaphoresis, and fear. He developed tunnel vision and his hearing waned then he blacked out...unconscious for roughly 5-10 min. When he woke he felt foggy taking him roughly ~1-2 min for his vision and hearing to return to NL. No associated aura, injury, tongue biting, incontinence, seizure activity, decreased PO intake, recent fatigue, steroid use, or other illicit drug use. 9 Jan 2019, per DC summary: NL orthostatics, no acute abnormalities on EKG. VS stable. Telemetry w/ rare PVCs overnight. Patient w/ + trop which resolved (0.09--0.01--<.01). Echo showed regional wall motion abnormalities. [evidence of an abnormal regional strain at the basal inferior lateral wall but with no e/o RWMA] Restricted profile. 14 Jan 2019, PCM  Asymptomatic except a couple episodes of palpitations since discharge.
Age: 29.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL
Symptoms: Troponin I increased
Clinical narrative: Patient ran marathon 6 days post-SPV, and after completing his marathon he was sick for approximately 2 weeks with diffuse myalgia, dyspnea and HR well above 100 bpm for a week straight -> syncope. 7 Jan 2019, PCM  CC: "irregular heart beats" irregular heart beat started 2 weeks after receiving the smallpox vaccination (24 Dec 2018). heart feels as if it occasionally skips a beat and is then followed up by a large beatfeels lightheaded when working outoccasionally his heart is beating harder than normal. Runs 3 miles w/o symptoms. No chest pain, dyspnea. 8 Jan 2019, Adm H&P:  syncopal episode w/ increasing palpitationspalpitations started around  time he finished marathon 4 weeks ago (16 Dec, PVD 6) After notification of abnormal labs on 7 Jan, felt anxious w/ brief ~5-10 sec of left sided sharp mid axillary chest pain. While at dinner, pt felt little dizzy/light headed with diaphoresis, and fear. He developed tunnel vision and his hearing waned then he blacked out...unconscious for roughly 5-10 min. When he woke he felt foggy taking him roughly ~1-2 min for his vision and hearing to return to NL. No associated aura, injury, tongue biting, incontinence, seizure activity, decreased PO intake, recent fatigue, steroid use, or other illicit drug use. 9 Jan 2019, per DC summary: NL orthostatics, no acute abnormalities on EKG. VS stable. Telemetry w/ rare PVCs overnight. Patient w/ + trop which resolved (0.09--0.01--<.01). Echo showed regional wall motion abnormalities. [evidence of an abnormal regional strain at the basal inferior lateral wall but with no e/o RWMA] Restricted profile. 14 Jan 2019, PCM  Asymptomatic except a couple episodes of palpitations since discharge.
Age: 29.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL
Symptoms: Anxiety, Blood creatine phosphokinase increased, Blood thyroid stimulating hormone normal, Brain natriuretic peptide normal, Chest X-ray normal
Clinical narrative: Patient ran marathon 6 days post-SPV, and after completing his marathon he was sick for approximately 2 weeks with diffuse myalgia, dyspnea and HR well above 100 bpm for a week straight -> syncope. 7 Jan 2019, PCM  CC: "irregular heart beats" irregular heart beat started 2 weeks after receiving the smallpox vaccination (24 Dec 2018). heart feels as if it occasionally skips a beat and is then followed up by a large beatfeels lightheaded when working outoccasionally his heart is beating harder than normal. Runs 3 miles w/o symptoms. No chest pain, dyspnea. 8 Jan 2019, Adm H&P:  syncopal episode w/ increasing palpitationspalpitations started around  time he finished marathon 4 weeks ago (16 Dec, PVD 6) After notification of abnormal labs on 7 Jan, felt anxious w/ brief ~5-10 sec of left sided sharp mid axillary chest pain. While at dinner, pt felt little dizzy/light headed with diaphoresis, and fear. He developed tunnel vision and his hearing waned then he blacked out...unconscious for roughly 5-10 min. When he woke he felt foggy taking him roughly ~1-2 min for his vision and hearing to return to NL. No associated aura, injury, tongue biting, incontinence, seizure activity, decreased PO intake, recent fatigue, steroid use, or other illicit drug use. 9 Jan 2019, per DC summary: NL orthostatics, no acute abnormalities on EKG. VS stable. Telemetry w/ rare PVCs overnight. Patient w/ + trop which resolved (0.09--0.01--<.01). Echo showed regional wall motion abnormalities. [evidence of an abnormal regional strain at the basal inferior lateral wall but with no e/o RWMA] Restricted profile. 14 Jan 2019, PCM  Asymptomatic except a couple episodes of palpitations since discharge.
Age: 29.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL
Symptoms: Chest pain, Dizziness, Drug screen negative, Dyspnoea, Echocardiogram abnormal
Clinical narrative: Patient ran marathon 6 days post-SPV, and after completing his marathon he was sick for approximately 2 weeks with diffuse myalgia, dyspnea and HR well above 100 bpm for a week straight -> syncope. 7 Jan 2019, PCM  CC: "irregular heart beats" irregular heart beat started 2 weeks after receiving the smallpox vaccination (24 Dec 2018). heart feels as if it occasionally skips a beat and is then followed up by a large beatfeels lightheaded when working outoccasionally his heart is beating harder than normal. Runs 3 miles w/o symptoms. No chest pain, dyspnea. 8 Jan 2019, Adm H&P:  syncopal episode w/ increasing palpitationspalpitations started around  time he finished marathon 4 weeks ago (16 Dec, PVD 6) After notification of abnormal labs on 7 Jan, felt anxious w/ brief ~5-10 sec of left sided sharp mid axillary chest pain. While at dinner, pt felt little dizzy/light headed with diaphoresis, and fear. He developed tunnel vision and his hearing waned then he blacked out...unconscious for roughly 5-10 min. When he woke he felt foggy taking him roughly ~1-2 min for his vision and hearing to return to NL. No associated aura, injury, tongue biting, incontinence, seizure activity, decreased PO intake, recent fatigue, steroid use, or other illicit drug use. 9 Jan 2019, per DC summary: NL orthostatics, no acute abnormalities on EKG. VS stable. Telemetry w/ rare PVCs overnight. Patient w/ + trop which resolved (0.09--0.01--<.01). Echo showed regional wall motion abnormalities. [evidence of an abnormal regional strain at the basal inferior lateral wall but with no e/o RWMA] Restricted profile. 14 Jan 2019, PCM  Asymptomatic except a couple episodes of palpitations since discharge.
Age: 29.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL
Symptoms: Electrocardiogram T wave abnormal, Electrocardiogram abnormal, Extrasystoles, Fear, Feeling abnormal
Clinical narrative: Patient ran marathon 6 days post-SPV, and after completing his marathon he was sick for approximately 2 weeks with diffuse myalgia, dyspnea and HR well above 100 bpm for a week straight -> syncope. 7 Jan 2019, PCM  CC: "irregular heart beats" irregular heart beat started 2 weeks after receiving the smallpox vaccination (24 Dec 2018). heart feels as if it occasionally skips a beat and is then followed up by a large beatfeels lightheaded when working outoccasionally his heart is beating harder than normal. Runs 3 miles w/o symptoms. No chest pain, dyspnea. 8 Jan 2019, Adm H&P:  syncopal episode w/ increasing palpitationspalpitations started around  time he finished marathon 4 weeks ago (16 Dec, PVD 6) After notification of abnormal labs on 7 Jan, felt anxious w/ brief ~5-10 sec of left sided sharp mid axillary chest pain. While at dinner, pt felt little dizzy/light headed with diaphoresis, and fear. He developed tunnel vision and his hearing waned then he blacked out...unconscious for roughly 5-10 min. When he woke he felt foggy taking him roughly ~1-2 min for his vision and hearing to return to NL. No associated aura, injury, tongue biting, incontinence, seizure activity, decreased PO intake, recent fatigue, steroid use, or other illicit drug use. 9 Jan 2019, per DC summary: NL orthostatics, no acute abnormalities on EKG. VS stable. Telemetry w/ rare PVCs overnight. Patient w/ + trop which resolved (0.09--0.01--<.01). Echo showed regional wall motion abnormalities. [evidence of an abnormal regional strain at the basal inferior lateral wall but with no e/o RWMA] Restricted profile. 14 Jan 2019, PCM  Asymptomatic except a couple episodes of palpitations since discharge.
Age: 29.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL
Symptoms: Fibrin D dimer normal, Full blood count normal, Heart rate increased, Heart rate irregular, Hyperhidrosis
Clinical narrative: Patient ran marathon 6 days post-SPV, and after completing his marathon he was sick for approximately 2 weeks with diffuse myalgia, dyspnea and HR well above 100 bpm for a week straight -> syncope. 7 Jan 2019, PCM  CC: "irregular heart beats" irregular heart beat started 2 weeks after receiving the smallpox vaccination (24 Dec 2018). heart feels as if it occasionally skips a beat and is then followed up by a large beatfeels lightheaded when working outoccasionally his heart is beating harder than normal. Runs 3 miles w/o symptoms. No chest pain, dyspnea. 8 Jan 2019, Adm H&P:  syncopal episode w/ increasing palpitationspalpitations started around  time he finished marathon 4 weeks ago (16 Dec, PVD 6) After notification of abnormal labs on 7 Jan, felt anxious w/ brief ~5-10 sec of left sided sharp mid axillary chest pain. While at dinner, pt felt little dizzy/light headed with diaphoresis, and fear. He developed tunnel vision and his hearing waned then he blacked out...unconscious for roughly 5-10 min. When he woke he felt foggy taking him roughly ~1-2 min for his vision and hearing to return to NL. No associated aura, injury, tongue biting, incontinence, seizure activity, decreased PO intake, recent fatigue, steroid use, or other illicit drug use. 9 Jan 2019, per DC summary: NL orthostatics, no acute abnormalities on EKG. VS stable. Telemetry w/ rare PVCs overnight. Patient w/ + trop which resolved (0.09--0.01--<.01). Echo showed regional wall motion abnormalities. [evidence of an abnormal regional strain at the basal inferior lateral wall but with no e/o RWMA] Restricted profile. 14 Jan 2019, PCM  Asymptomatic except a couple episodes of palpitations since discharge.
Age: 29.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL
Symptoms: Hypoacusis, Lipids normal, Loss of consciousness, Malaise, Metabolic function test normal
Clinical narrative: Patient ran marathon 6 days post-SPV, and after completing his marathon he was sick for approximately 2 weeks with diffuse myalgia, dyspnea and HR well above 100 bpm for a week straight -> syncope. 7 Jan 2019, PCM  CC: "irregular heart beats" irregular heart beat started 2 weeks after receiving the smallpox vaccination (24 Dec 2018). heart feels as if it occasionally skips a beat and is then followed up by a large beatfeels lightheaded when working outoccasionally his heart is beating harder than normal. Runs 3 miles w/o symptoms. No chest pain, dyspnea. 8 Jan 2019, Adm H&P:  syncopal episode w/ increasing palpitationspalpitations started around  time he finished marathon 4 weeks ago (16 Dec, PVD 6) After notification of abnormal labs on 7 Jan, felt anxious w/ brief ~5-10 sec of left sided sharp mid axillary chest pain. While at dinner, pt felt little dizzy/light headed with diaphoresis, and fear. He developed tunnel vision and his hearing waned then he blacked out...unconscious for roughly 5-10 min. When he woke he felt foggy taking him roughly ~1-2 min for his vision and hearing to return to NL. No associated aura, injury, tongue biting, incontinence, seizure activity, decreased PO intake, recent fatigue, steroid use, or other illicit drug use. 9 Jan 2019, per DC summary: NL orthostatics, no acute abnormalities on EKG. VS stable. Telemetry w/ rare PVCs overnight. Patient w/ + trop which resolved (0.09--0.01--<.01). Echo showed regional wall motion abnormalities. [evidence of an abnormal regional strain at the basal inferior lateral wall but with no e/o RWMA] Restricted profile. 14 Jan 2019, PCM  Asymptomatic except a couple episodes of palpitations since discharge.
Age: 29.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL
Symptoms: Myalgia, Myocarditis, Nuclear magnetic resonance imaging abnormal, Nuclear magnetic resonance imaging heart, Palpitations
Clinical narrative: Patient ran marathon 6 days post-SPV, and after completing his marathon he was sick for approximately 2 weeks with diffuse myalgia, dyspnea and HR well above 100 bpm for a week straight -> syncope. 7 Jan 2019, PCM  CC: "irregular heart beats" irregular heart beat started 2 weeks after receiving the smallpox vaccination (24 Dec 2018). heart feels as if it occasionally skips a beat and is then followed up by a large beatfeels lightheaded when working outoccasionally his heart is beating harder than normal. Runs 3 miles w/o symptoms. No chest pain, dyspnea. 8 Jan 2019, Adm H&P:  syncopal episode w/ increasing palpitationspalpitations started around  time he finished marathon 4 weeks ago (16 Dec, PVD 6) After notification of abnormal labs on 7 Jan, felt anxious w/ brief ~5-10 sec of left sided sharp mid axillary chest pain. While at dinner, pt felt little dizzy/light headed with diaphoresis, and fear. He developed tunnel vision and his hearing waned then he blacked out...unconscious for roughly 5-10 min. When he woke he felt foggy taking him roughly ~1-2 min for his vision and hearing to return to NL. No associated aura, injury, tongue biting, incontinence, seizure activity, decreased PO intake, recent fatigue, steroid use, or other illicit drug use. 9 Jan 2019, per DC summary: NL orthostatics, no acute abnormalities on EKG. VS stable. Telemetry w/ rare PVCs overnight. Patient w/ + trop which resolved (0.09--0.01--<.01). Echo showed regional wall motion abnormalities. [evidence of an abnormal regional strain at the basal inferior lateral wall but with no e/o RWMA] Restricted profile. 14 Jan 2019, PCM  Asymptomatic except a couple episodes of palpitations since discharge.
Age: 29.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL
Symptoms: QRS axis abnormal, Red blood cell sedimentation rate normal, Sinus rhythm, Syncope, Troponin I increased
Clinical narrative: Patient ran marathon 6 days post-SPV, and after completing his marathon he was sick for approximately 2 weeks with diffuse myalgia, dyspnea and HR well above 100 bpm for a week straight -> syncope. 7 Jan 2019, PCM  CC: "irregular heart beats" irregular heart beat started 2 weeks after receiving the smallpox vaccination (24 Dec 2018). heart feels as if it occasionally skips a beat and is then followed up by a large beatfeels lightheaded when working outoccasionally his heart is beating harder than normal. Runs 3 miles w/o symptoms. No chest pain, dyspnea. 8 Jan 2019, Adm H&P:  syncopal episode w/ increasing palpitationspalpitations started around  time he finished marathon 4 weeks ago (16 Dec, PVD 6) After notification of abnormal labs on 7 Jan, felt anxious w/ brief ~5-10 sec of left sided sharp mid axillary chest pain. While at dinner, pt felt little dizzy/light headed with diaphoresis, and fear. He developed tunnel vision and his hearing waned then he blacked out...unconscious for roughly 5-10 min. When he woke he felt foggy taking him roughly ~1-2 min for his vision and hearing to return to NL. No associated aura, injury, tongue biting, incontinence, seizure activity, decreased PO intake, recent fatigue, steroid use, or other illicit drug use. 9 Jan 2019, per DC summary: NL orthostatics, no acute abnormalities on EKG. VS stable. Telemetry w/ rare PVCs overnight. Patient w/ + trop which resolved (0.09--0.01--<.01). Echo showed regional wall motion abnormalities. [evidence of an abnormal regional strain at the basal inferior lateral wall but with no e/o RWMA] Restricted profile. 14 Jan 2019, PCM  Asymptomatic except a couple episodes of palpitations since discharge.
Age: 29.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL
Symptoms: Tunnel vision, Ventricular extrasystoles, Visual impairment
Clinical narrative: Patient ran marathon 6 days post-SPV, and after completing his marathon he was sick for approximately 2 weeks with diffuse myalgia, dyspnea and HR well above 100 bpm for a week straight -> syncope. 7 Jan 2019, PCM  CC: "irregular heart beats" irregular heart beat started 2 weeks after receiving the smallpox vaccination (24 Dec 2018). heart feels as if it occasionally skips a beat and is then followed up by a large beatfeels lightheaded when working outoccasionally his heart is beating harder than normal. Runs 3 miles w/o symptoms. No chest pain, dyspnea. 8 Jan 2019, Adm H&P:  syncopal episode w/ increasing palpitationspalpitations started around  time he finished marathon 4 weeks ago (16 Dec, PVD 6) After notification of abnormal labs on 7 Jan, felt anxious w/ brief ~5-10 sec of left sided sharp mid axillary chest pain. While at dinner, pt felt little dizzy/light headed with diaphoresis, and fear. He developed tunnel vision and his hearing waned then he blacked out...unconscious for roughly 5-10 min. When he woke he felt foggy taking him roughly ~1-2 min for his vision and hearing to return to NL. No associated aura, injury, tongue biting, incontinence, seizure activity, decreased PO intake, recent fatigue, steroid use, or other illicit drug use. 9 Jan 2019, per DC summary: NL orthostatics, no acute abnormalities on EKG. VS stable. Telemetry w/ rare PVCs overnight. Patient w/ + trop which resolved (0.09--0.01--<.01). Echo showed regional wall motion abnormalities. [evidence of an abnormal regional strain at the basal inferior lateral wall but with no e/o RWMA] Restricted profile. 14 Jan 2019, PCM  Asymptomatic except a couple episodes of palpitations since discharge.
Age: 20.0
Sex: M
Vaccine: FLUC4, FLUC4
Symptoms: Dizziness, Electroencephalogram normal, Nausea, Seizure like phenomena
Clinical narrative: Loss of consciousness, seizure like activity, possible tonic-clonic seizure approximately 10 minutes after injection of vaccine. Extremely low heart rate, grey skin, sweaty brow, no memory or knowledge of event, faint and weak, hearing going in and out, trouble finding words, confusion happening after seizure.
Age: 20.0
Sex: M
Vaccine: FLUC4, FLUC4
Symptoms: Aphasia, Asthenia, Blood lactic acid, Cardiac monitoring, Computerised tomogram head
Clinical narrative: Loss of consciousness, seizure like activity, possible tonic-clonic seizure approximately 10 minutes after injection of vaccine. Extremely low heart rate, grey skin, sweaty brow, no memory or knowledge of event, faint and weak, hearing going in and out, trouble finding words, confusion happening after seizure.
Age: 20.0
Sex: M
Vaccine: FLUC4, FLUC4
Symptoms: Confusional state, Differential white blood cell count, Drug screen, Electrocardiogram, Full blood count
Clinical narrative: Loss of consciousness, seizure like activity, possible tonic-clonic seizure approximately 10 minutes after injection of vaccine. Extremely low heart rate, grey skin, sweaty brow, no memory or knowledge of event, faint and weak, hearing going in and out, trouble finding words, confusion happening after seizure.
Age: 20.0
Sex: M
Vaccine: FLUC4, FLUC4
Symptoms: Heart rate decreased, Hyperhidrosis, Hypoacusis, Loss of consciousness, Metabolic function test
Clinical narrative: Loss of consciousness, seizure like activity, possible tonic-clonic seizure approximately 10 minutes after injection of vaccine. Extremely low heart rate, grey skin, sweaty brow, no memory or knowledge of event, faint and weak, hearing going in and out, trouble finding words, confusion happening after seizure.
Age: 20.0
Sex: M
Vaccine: FLUC4, FLUC4
Symptoms: Seizure like phenomena, Skin discolouration, Syncope, Urine alcohol test, Urine analysis
Clinical narrative: Loss of consciousness, seizure like activity, possible tonic-clonic seizure approximately 10 minutes after injection of vaccine. Extremely low heart rate, grey skin, sweaty brow, no memory or knowledge of event, faint and weak, hearing going in and out, trouble finding words, confusion happening after seizure.
Age: 1.0
Sex: F
Vaccine: DTAP
Symptoms: Febrile convulsion
Clinical narrative: Ferbile Seizure.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Guillain-Barre syndrome, Lumbar puncture abnormal
Clinical narrative: Guillain-Barré Syndrome.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Nausea, Pain in extremity, Pyrexia
Clinical narrative: Patient reported that she had the vaccine on Friday 01/11/19 at 2pm and on Saturday morning at 2am developed arm pain, fever, chills, nausea, vomiting and fatigue. The symptoms continued and she felt better on Sunday 01/13 and reported the side effects to us on Monday 01/14/19 when she reported that she was feeling much better.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: Patient reported that she had the vaccine on Friday 01/11/19 at 2pm and on Saturday morning at 2am developed arm pain, fever, chills, nausea, vomiting and fatigue. The symptoms continued and she felt better on Sunday 01/13 and reported the side effects to us on Monday 01/14/19 when she reported that she was feeling much better.
Sex: M
Vaccine: PPV
Symptoms: Fluid retention
Clinical narrative: This spontaneous report was received from a pharmacist referring to a male patient of unknown age. Information of concurrent condition, pertinent medical history, concomitant medication and drug reactions/allergies was unknown. On around 11-DEC-2018, the patient was vaccinated with PNEUMOVAX 23 (strength, dose, lot # and expiration date were unknown) intramuscularly for prophylaxis (reported as patient was due for it). On an unknown date in December 2018, the patient developed "fluid in his bicep". The outcome of the event was unknown. The patient contacted pharmacy on an unknown date. It was unknown if patient was given treatment or performed lab diagnostics/studies. The causality between PNEUMOVAX 23 and the event was not provided.
Sex: U
Vaccine: DTAPHEPBIP, HEP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown gender and age. The patient's pertinent medical history, concomitant medications, drug reactions or allergies were not reported. On 03-JAN-2019, the patient was vaccinated with RECOMBIVAX HB (dose, frequency, anatomical location, lot number and expiration date were not provided) intramuscularly as prophylaxis. On the same day, the patient was vaccinated with PEDIARIX (dose, frequency, route of administration, anatomical location, lot number and expiration date were not provided) as prophylaxis as well (overdose). No adverse effects were known.
Sex: F
Vaccine: MMR
Symptoms: Unevaluable event
Clinical narrative: This spontaneous report was received from a medical assistant regarding a 17-year-old female patient. The patient's medical history, drug allergies/reaction, concurrent conditions and concomitant medications were not reported. On an unspecified date in 2003, the patient was vaccinated with M-M-R II (dose, frequency, lot# and expiry date were unknown) via subcutaneous route for prophylaxis. Other suspect therapies included sterile diluent (dose, frequency, lot# and expiry date were unknown). On an unknown date, it was reported that the patient was waiting for a lung transplant" for an unspecified reason" (lung transplant). It was reported that patient was seen in doctor's office and sought medical attention. Action taken with sterile diluent was unknown. The outcome of lung transplant was reported was not recovered at the time of report. The causality assessment was not given by the reporter. Upon internal review, lung transplant was determined to be medically significant.
Age: 1.0
Sex: U
Vaccine: MMR, MMRV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 12-month-old patient of unknown gender. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On 09-JAN-2019, the patient was vaccinated with PROQUAD and M-M-R II (exact doses, lot# numbers and expiration dates were not reported) both for prophylaxis. It was reported that sterile diluent was used to reconstitute the vaccines. No adverse effects reported.
Age: 0.17
Sex: U
Vaccine: HEP, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 8 week old patient of unknown gender. The patient's concurrent conditions, medical history, concomitant medications, drug reactions or allergies were not reported. On 03-JAN-2019, the patient was vaccinated with improperly stored doses of ROTATEQ lot # R002516, expiration date 13-SEP-2019, orally, (dose and frequency were not reported) for prophylaxis; and RECOMBIVAX HB lot # R004185, expiration date 06-NOV-2020, intramuscularly (dose and frequency were not reported) for prophylaxis.  The improperly stored vaccines were stored at a temperature of 0.6 Celsius degrees (C) (also reported as "below 36 fahrenheit degrees/2 C") for 53 hours. The call was made because of a data logger. There were no previous temperature excursions (it was also mentioned that there were multiple excursions (discrepant information). No adverse effects were reported and no product quality complaint (PQC) was involved. This is one of 2 reports received from the same reporter (MARRS # 1901USA005733).; Sender's Comments: US-009507513-1901USA005733:
Sex: F
Vaccine: VARCEL
Symptoms: Exposure via eye contact, Eye irrigation, Eye irritation
Clinical narrative: This spontaneous report was received from a nurse practitioner and refers to a female patient of unknown age. The patient's historical condition, concomitant medications and drug reactions or allergies were not reported. On an unknown date, the patient accidentally splashed an unknown amount of VARIVAX into an unspecified eye (exposure via eye contact). The patient reports that her "eye was burning" (eye irritation), and she was instructed to flush her eyes with an eye wash. The patient sought medical attention with the nurse practitioner. At the time of the report, the patient had not recovered from the eye irritation. The causality between the event eye irritation and VARIVAX was unknown.
Sex: U
Vaccine: PPV
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a registered Licensed Practical Nurse and refers to an unspecified number of patients of unknown age and gender. The concurrent conditions, medical history and concomitant medications of the patients were unknown. On unknown dates, the patients were vaccinated with"one or two" improperly stored doses of PNEUMOVAX 23 lot # N025563, expiration date 08-APR-2019 for prophylaxis (strength, dose number, anatomical location and route of administration were not reported). The administered vaccines had temperature excursion below 36 degree Fahrenheit  (°F) (32F) for 4 hours and 48 minutes, additionally there was a previous temperature excursion  below 36°F (33.8F) for 1 hour  and 40 minutes. The called was because a digital data logger.
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Rash
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On an unspecified date, the patient was inoculated with ZOSTAVAX for routine health maintenance and for the prevention of shingles (dose, route, and lot # not provided). Following the vaccination (date not specified), the patient experienced a painful rash accompanied by persistent pain. As a result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages.  As a direct and proximate result of ZOSTAVAX, the patient's symptoms and diagnoses have resulted in physical limitations not present prior to using the Company's product. As a result of ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of the Company's wrongful conduct, the patient suffered serious, progressive, permanent, incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The outcome of the events was not resolved. Causality assessment was related. The lawyer considered painful rash and persistent pain to be disabling. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Ophthalmic herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided.  The patient's healthcare provider recommended, and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about December 2015, a healthcare provider administered ZOSTAVAX, (lot# and route unknown) to the patient. The patient was inoculated with the ZOSTAVAX vaccine to obtain permanent prevention and protection against shingles and zoster-related injuries. On or about 20-MAR-2016, the patient was treated by a physician for ophthalmic shingles.  The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. The patient used the ZOSTAVAX vaccine for the permanent prevention of shingles and zoster-related injuries. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine.  As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. Upon internal review ophthalmic shingles was considered medically significant. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare providers recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related injuries. In 2009, a pharmacist administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). In 2009, the patient was treated by a physician for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Age: 0.58
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 7 Months old patient of unknown gender. The patient's concurrent conditions, medical history, concomitant medications, drug reactions or allergies were not reported. On 03-JAN-2019, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB lot # R004185, expiration date 06-NOV-2020, intramuscularly (dose and frequency were not reported) for prophylaxis. The improperly stored vaccine was stored at a temperature of 0.6 Celsius degrees (C) (also reported as below 36 Fahrenheit degrees/2 C) for 53 hours. The call was made because of a data logger. There were no previous temperature excursions (it was also mentioned that there were multiple excursions (discrepant information). No adverse effects were reported and no product quality complaint (PQC) was involved. This is one of 2 reports received from the same reporter (MARRS # 1901USA003925). Sender's Comments: US-009507513-1901USA003925.
Sex: F
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Loss of personal independence in daily activities, Musculoskeletal pain, Pain in extremity
Clinical narrative: This case was reported by a consumer and described the occurrence of pain in arm in a female patient who received FLUARIX QUADRIVALENT 2018-2019 season (batch number Y53NN, expiry date 30th June 2019) for prophylaxis. On 26th October 2018, the patient received FLUARIX QUADRIVALENT 2018-2019 season. On 26th October 2018, immediately after receiving FLUARIX QUADRIVALENT 2018-2019 season, the patient experienced pain in arm and shoulder pain. On an unknown date, the patient experienced injected limb mobility decreased and activities of daily living impaired. On an unknown date, the outcome of the pain in arm, shoulder pain, injected limb mobility decreased and activities of daily living impaired were not recovered/not resolved. It was unknown if the reporter considered the pain in arm, shoulder pain, injected limb mobility decreased and activities of daily living impaired to be related to FLUARIX QUADRIVALENT 2018-2019 season. Additional details were provided as follows: This case was reported by a pharmacy via a pharmacy claims management company. The age at vaccination was not reported. The patient experienced pain immediately after receiving the FLUARIX. At the time of reporting, it has been several months and the pain has not gone away in her left shoulder and arm. Less than year after receiving FLUARIX, it was hard to lift arm or perform daily tasks. The patient had sought medical treatment because of these events.
Age: 83.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Chills, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 83-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2018-2019 season) for prophylaxis. Previously administered products included SHINGRIX (1st dose received in summer in 2018 with no problem) and Statin with an associated reaction of pain in extremity. On 17th September 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) and Influenza vaccine Quadrivalent 2018-2019 season (intramuscular). On 17th September 2018, less than a day after receiving SHINGRIX and Influenza vaccine Quadrivalent 2018-2019 season, the patient experienced pain in arm, chills and limbs stiffness. On an unknown date, the outcome of the pain in arm and limbs stiffness were not recovered/not resolved and the outcome of the chills was recovered/resolved.  The reporter considered the pain in arm, chills and limbs stiffness to be related to SHINGRIX. It was unknown if the reporter considered the pain in arm, chills and limbs stiffness to be related to Influenza vaccine Quadrivalent 2018-2019 season. Additional details were received as follows: The patient had issued in the past when she was taking statins. Statin caused so much arm pain, hence she stopped taking them. The patient received SHINGRIX vaccine in left arm and Flu vaccine in right arm. On the same day after vaccination with SHINGRIX, the patient presented with pain in her left arm and chills. The chills resolved after 2 days but the pain in her left arm remains. During the day when the patient was moving around, her arm was little stiff but at night when she went to bed she woke up at about 2 or 3am with severe pain in her arm. The patient was given a flu vaccine on the same day in her right arm but did not associate the side effects with this vaccine.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 69-year-old female patient who received SHINGRIX for prophylaxis.  On 28th December 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced injection site erythema and injection site swelling. On an unknown date, the outcome of the injection site erythema and injection site swelling were not recovered/not resolved. It was unknown if the reporter considered the injection site erythema and injection site swelling to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported but it could be 68 year or 69 years. The patient expereinced local injection site reaction of redness and swelling. On the day of reporting, the patient went to the pharmacy and she was asking about the local reactions. At the time of report, the patient was still experiencing redness and swelling. The pharmacist did not have any additional information to provide. The pharmacist did not give consent for follow up.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Extensive swelling of vaccinated limb, Fatigue, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 70-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included splenectomy. Concurrent medical conditions included thyroid disorder, diabetes, cirrhosis of liver without mention of alcohol and idiopathic thrombocytopenic purpura. Concomitant products included thyroxine sodium (Levothyroxine). In December 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In December 2018, 3 days after receiving SHINGRIX, the patient experienced extensive swelling of vaccinated limb, injection site erythema, injection site warmth and injection site pain. On an unknown date, the patient experienced fatigue and daytime sleepiness. The patient was treated with acetylsalicylic acid (Aspirin). On an unknown date, the outcome of the extensive swelling of vaccinated limb was recovering/resolving and the outcome of the injection site erythema and injection site warmth were recovered/resolved and the outcome of the fatigue and daytime sleepiness were unknown and the outcome of the injection site pain was not recovered/not resolved. It was unknown if the reporter considered the extensive swelling of vaccinated limb, injection site erythema, injection site warmth, fatigue, injection site pain and daytime sleepiness to be related to SHINGRIX. Additional details were provided as follows: About 3 days after receiving the vaccine the site around the injection site was swollen, red and hot covering area of 7 inches by 7 inches. The events red and hot were not anymore, but the area was still little bit swollen. The patient tried putting ice and taken aspirin to help with the pain. The patient did not know the full form of ITP. Accidentally hit one when they asked patient how much time it took to get it. The patient called yesterday and was put on a list and they will been going to call her back and the phone probably was dead, but she waited they know, she did not know, three or four minutes and then went on the call list. Today, when the patient talked to a representative, she was surprised that they called her or answered the phone, (inaudible) on the other end, that was excellent. As far as referring people to their company, it was depending on what the doctor prescribes for her and she trust on her doctor. However, the patient had a reaction and still in a lot of pain in her left arm, it was being almost a month and they can read the report where it was swollen. But as far as the representative, they were great, courteous, and just, you know, directed patient through, so she could not had asked for a better person to do that No further details were provided at time of reporting.