chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: This is a spontaneous report received from a medical assistant referring to a patient of unknown age and gender who received a dose of ZOSTAVAX on 14-JUN-20187 (lot# M042854, exp. 18-JAN-2018) for prophylaxis. The medical assistant reported that the patient received the injection of ZOSTAVAX intramuscularly which is outside of the recommendations per prescribing information. No adverse effect was reported. Lot number M042854 has been verified to be a valid lot number for Zoster Vaccine Live.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist, concerning a patient of an unknown age and gender. There were no concurrent conditions, medical history, drug reactions, allergies or concomitant medications reported. On an unspecified date, the patient may have been vaccinated, via intramuscular instead of the subcutaneous route, with a dose of Oka/Merck VARIVAX injection (dose and frequency were not reported) lot # reported as N012134 with expiration date of 17-APR-2019, for prophylaxis. No adverse effects were reported. Lot number N012134 has been verified to be a valid lot number for varicella virus vaccine live.
Age: 48.0
Sex: F
Vaccine: MMR
Symptoms: Measles antibody negative
Clinical narrative: This spontaneous report was received from a medical assistant regarding a 48 year old female patient. No information was provided regarding the patient's medical, drug and allergy history, concomitant medications or concurrent conditions. On 10-MAR-2018, the patient was vaccinated with a dose of (WISTAR RA 27/3) M-M-R-II (recombinant Human albumin rHA) subcutaneously, lot number N0091969, expiry date: 20-MAR-2019 for prophylaxis as a requirement to work with children (dosage was unknown). Later the same month, a MMRII titer was done and did not show an antibody for measles (Measles antibody negative). It was reported that the patient sought medical attention and received treatment. The action taken with Measles antibody negative was unknown. The outcome of the event Measles antibody negative and the causal relationship between the event and therapy with (WISTAR RA 27/3) M-M-R-II were not reported.
Age: 11.0
Sex: F
Vaccine: VARCEL
Symptoms: Acquired immunodeficiency syndrome, Blindness unilateral, CD4 lymphocytes decreased, CSF white blood cell count increased, Cytomegalovirus chorioretinitis
Clinical narrative: This literature marketed report as received from the authors of a published article, refers to an 11-year-old with a history of failure to thrive, febrile seizures, and a vesicular rash following the varicella vaccination (manufacturer unknown) (strength, lot number, expiry date, dose, route and date of administration were not reported). The patient presented with one week of occipital headaches and hypertensive urgency. She developed fever and vision loss in the left eye two days after admission (reason unspecified), with new reports of a partial right visual field deficit for one month. Magnetic resonance (MRI) findings were consistent with meningoencephalitis. The cerebrospinal fluid revealed 34 (units not provided) white blood cells and a positive vaccine strain varicella (VZV) polymerase chain reaction (PCR). Serum cytomegalovirus (CMV) IgG was greater than 10,000 u/mL. Ultimately, the patient was diagnosed with meningoencephalitis and left optic neuritis secondary to VZV and right eye CMV retinitis. Due to the patient's multiple opportunistic infections, an immune work up was initiated. Her HIV antigen and antibody tests were positive, and her CD4 count was 0 cells/mm3 leading to the diagnosis of AIDS. The outcome of vesicular rash, meningoencephalitis, positive vaccine strain varicella (VZV) PCR and left optic neuritis was not reported. Upon internal review, the events meningoencephalitis and left optic neuritis were considered medically significant.
Age: 11.0
Sex: F
Vaccine: VARCEL
Symptoms: Cytomegalovirus test positive, Encephalitis, HIV antibody positive, HIV antigen positive, Headache
Clinical narrative: This literature marketed report as received from the authors of a published article, refers to an 11-year-old with a history of failure to thrive, febrile seizures, and a vesicular rash following the varicella vaccination (manufacturer unknown) (strength, lot number, expiry date, dose, route and date of administration were not reported). The patient presented with one week of occipital headaches and hypertensive urgency. She developed fever and vision loss in the left eye two days after admission (reason unspecified), with new reports of a partial right visual field deficit for one month. Magnetic resonance (MRI) findings were consistent with meningoencephalitis. The cerebrospinal fluid revealed 34 (units not provided) white blood cells and a positive vaccine strain varicella (VZV) polymerase chain reaction (PCR). Serum cytomegalovirus (CMV) IgG was greater than 10,000 u/mL. Ultimately, the patient was diagnosed with meningoencephalitis and left optic neuritis secondary to VZV and right eye CMV retinitis. Due to the patient's multiple opportunistic infections, an immune work up was initiated. Her HIV antigen and antibody tests were positive, and her CD4 count was 0 cells/mm3 leading to the diagnosis of AIDS. The outcome of vesicular rash, meningoencephalitis, positive vaccine strain varicella (VZV) PCR and left optic neuritis was not reported. Upon internal review, the events meningoencephalitis and left optic neuritis were considered medically significant.
Age: 11.0
Sex: F
Vaccine: VARCEL
Symptoms: Hypertensive crisis, Nuclear magnetic resonance imaging brain abnormal, Opportunistic infection, Optic neuritis, Polymerase chain reaction positive
Clinical narrative: This literature marketed report as received from the authors of a published article, refers to an 11-year-old with a history of failure to thrive, febrile seizures, and a vesicular rash following the varicella vaccination (manufacturer unknown) (strength, lot number, expiry date, dose, route and date of administration were not reported). The patient presented with one week of occipital headaches and hypertensive urgency. She developed fever and vision loss in the left eye two days after admission (reason unspecified), with new reports of a partial right visual field deficit for one month. Magnetic resonance (MRI) findings were consistent with meningoencephalitis. The cerebrospinal fluid revealed 34 (units not provided) white blood cells and a positive vaccine strain varicella (VZV) polymerase chain reaction (PCR). Serum cytomegalovirus (CMV) IgG was greater than 10,000 u/mL. Ultimately, the patient was diagnosed with meningoencephalitis and left optic neuritis secondary to VZV and right eye CMV retinitis. Due to the patient's multiple opportunistic infections, an immune work up was initiated. Her HIV antigen and antibody tests were positive, and her CD4 count was 0 cells/mm3 leading to the diagnosis of AIDS. The outcome of vesicular rash, meningoencephalitis, positive vaccine strain varicella (VZV) PCR and left optic neuritis was not reported. Upon internal review, the events meningoencephalitis and left optic neuritis were considered medically significant.
Age: 11.0
Sex: F
Vaccine: VARCEL
Symptoms: Pyrexia, Rash vesicular, Varicella virus test positive, Visual field defect
Clinical narrative: This literature marketed report as received from the authors of a published article, refers to an 11-year-old with a history of failure to thrive, febrile seizures, and a vesicular rash following the varicella vaccination (manufacturer unknown) (strength, lot number, expiry date, dose, route and date of administration were not reported). The patient presented with one week of occipital headaches and hypertensive urgency. She developed fever and vision loss in the left eye two days after admission (reason unspecified), with new reports of a partial right visual field deficit for one month. Magnetic resonance (MRI) findings were consistent with meningoencephalitis. The cerebrospinal fluid revealed 34 (units not provided) white blood cells and a positive vaccine strain varicella (VZV) polymerase chain reaction (PCR). Serum cytomegalovirus (CMV) IgG was greater than 10,000 u/mL. Ultimately, the patient was diagnosed with meningoencephalitis and left optic neuritis secondary to VZV and right eye CMV retinitis. Due to the patient's multiple opportunistic infections, an immune work up was initiated. Her HIV antigen and antibody tests were positive, and her CD4 count was 0 cells/mm3 leading to the diagnosis of AIDS. The outcome of vesicular rash, meningoencephalitis, positive vaccine strain varicella (VZV) PCR and left optic neuritis was not reported. Upon internal review, the events meningoencephalitis and left optic neuritis were considered medically significant.
Sex: F
Vaccine: HPV4
Symptoms: Arrhythmia, Dyspnoea, Syncope
Clinical narrative: This spontaneous report as received from a non-healthcare professional via Pfizer (Manufacturer Report Number: 2018116255) refers to a female patient of unknown age. The patient's medical history, current conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with GARDASIL (dosing information was not provided) for prophylaxis. According to the reporter, the vaccine which was advertised to help avoid cervical cancer in women, but was having devastating side effects. His son was dating a girl who had the vaccine, and now had all kinds of health issues- heart arhythmia, fainting, shortness of breath and really a mess. No reversal/cure (The outcome of the events was not recovered and patient did not receive any treatment). He reported that it was getting worse and they tried to talk all the kids into it these days. The reporter considered the causality for events to be related with GARDASIL. Upon internal review, arhythmia was determined to be medically significant. This is one of the two reports from same reporter.
Age: 18.0
Sex: F
Vaccine: FLU4, HPV9
Symptoms: Dizziness, Fall, Papilloma excision
Clinical narrative: This spontaneous report was received from an administrator, via a company representative, referring to a 19 year old female patient. The patient had no relevant medical history, drug reactions or allergies. On 14-NOV-2017, the patient was vaccinated with the third dose of GARDASIL 9 lot number: N017832, expiration date: 16-NOV-2019, intramuscularly, for prophylaxis (strength and dosage schedule were not reported). On the same day, the patient was also vaccinated with a dose of an unspecified influenza virus vaccine (lot number: UI889AV). On an unspecified date, the patient had a wart which was removed from her hand with unspecified treatment on an unknown date (recovered). On 14-NOV-2017, 15 minutes after vaccination when the patient was leaving the physician's office, she slid down the wall because she was getting dizzy. The administrator reported that patient received unspecified amounts of graham crackers, saltine crackers, water, and juice; additionally, the reporter informed that the patient's vitals sings, pulse and eyes examinations were normal. The patient was kept in the examination room for approximately 30 minutes, and released after being fully recovered. Causality assessment was not provided.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. No information was provided regarding the patients medical history, concurrent conditions, drug, allergy history or concomitant medications. On an unknown date, the patient was vaccinated with an improperly stored dose of Oka/Merck VARIVAX (strength, dose, frequency and route of administration were not provided) lot # N019822, expiration date 13-JUL-2019  for prophylaxis. Concomitant therapies included MRK STERILE DILUENT. The doses of Oka/Merck VARIVAX)were exposed to a temperature excursion of 6°Fahrenheit  (°F) to 14°F (8.8°F) during a time frame of 1 hour and 18 minutes, which was detected by the data logger. There was no previous temperature excursion. No adverse effects were reported. Sender's Comments: US-009507513-1804USA003063: US-009507513-1804USA003064: US-009507513-1804USA003065: US-009507513-1804USA003066: US-009507513-1804USA003067: US-009507513-1804USA003068: US-009507513-1804USA003069: US-009507513-1804USA003070: US-009507513-1804USA003071: US-009507513-1804USA003072: US-009507513-1804USA002453: US-009507513-1804USA003074: US-009507513-1804USA003075: US-009507513-1804USA003062.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. No information was provided regarding the patients medical history, concurrent conditions, drug, allergy history or concomitant medications. On an unknown date, the patient was vaccinated with an improperly stored dose of Oka/Merck VARIVAX (strength, dose, frequency and route of administration were not provided) lot # N019822, expiration date 13-JUL-2019 for prophylaxis. Concomitant therapies included MRK STERILE DILUENT. The doses of Oka/Merck VARIVAX were exposed to a temperature excursion of 6°Fahrenheit to 14°F (8.8°F) during a time frame of 1 hour and 18 minutes, which was detected by the data logger. There was no previous temperature excursion. No adverse effects were reported. Sender's Comments: US-009507513-1804USA003063: US-009507513-1804USA003064: US-009507513-1804USA003065: US-009507513-1804USA003066: US-009507513-1804USA003067: US-009507513-1804USA003068: US-009507513-1804USA003069: US-009507513-1804USA003070: US-009507513-1804USA003071: US-009507513-1804USA003072: US-009507513-1804USA003073: US-009507513-1804USA002453: US-009507513-1804USA003075: US-009507513-1804USA003062.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. No information was provided regarding the patients medical history, concurrent conditions, drug, allergy history or concomitant medications. On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX (strength, dose, frequency and route of administration were not provided) lot # N019822, expiration date 13-JUL-2019  for prophylaxis. Concomitant therapies included sterile diluent (MRK). The doses of VARIVAX were exposed to a temperature excursion of 6° Fahrenheit (°F) to 14°F (8.8°F) during a time frame of 1 hour and 18 minutes, which was detected by the data logger. There was no previous temperature excursion. No adverse effects were reported. Sender's Comments: US-009507513-1804USA003063: US-009507513-1804USA003064: US-009507513-1804USA003065: US-009507513-1804USA003066: US-009507513-1804USA003067: US-009507513-1804USA003068: US-009507513-1804USA003069: US-009507513-1804USA003070: US-009507513-1804USA003071: US-009507513-1804USA003072: US-009507513-1804USA003073: US-009507513-1804USA003074: US-009507513-1804USA002453: US-009507513-1804USA003062.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash erythematous
Clinical narrative: Red Rash on fingers, same arm as shot.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash generalised
Clinical narrative: Patient had vaccine 4/04/2018 with no complications at that time. On 4/09/2018 pt comes back to clinic c/o generalized rash over chest, back, arms and legs that started 4/08/2018. Pt denies new medications, foods, or new detergents or lotions. Denies fever, denies shortness of breath or wheezing.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Influenza like illness, Ocular discomfort, Pain, Pyrexia
Clinical narrative: Thu 4/5 pm got flu-like symptoms, Fri woke up with body aches, slight fever, headache, vision pulses, slowly went away, by Sun felt normal.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, RV1
Symptoms: Anxiety, Lethargy, Pain, Pyrexia, Screaming
Clinical narrative: After arriving home from the well visit our daughter within the hour started screaming uncontrollably (nothing I have ever witnessed), spiked a fever of 105. There was not consoling her or calming her down. She appeared to be in anguish and immense pain. The same evening she went to sleep for 14 hours. The days following she was lethargic and unresponsive.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, RV1
Symptoms: Unresponsive to stimuli
Clinical narrative: After arriving home from the well visit our daughter within the hour started screaming uncontrollably (nothing I have ever witnessed), spiked a fever of 105. There was not consoling her or calming her down. She appeared to be in anguish and immense pain. The same evening she went to sleep for 14 hours. The days following she was lethargic and unresponsive.
Age: 64.0
Sex: F
Vaccine: FLUC4
Symptoms: Injected limb mobility decreased, Pain, X-ray
Clinical narrative: Two days after receiving flu shot I couldn't move my right shoulder and upper arm. 3 months later I'm still having problems. The pain is getting a bit better but still do not have full mobility.
Age: 26.0
Sex: F
Vaccine: HEP, HEPA
Symptoms: Breath sounds abnormal, Bruxism, Dyspnoea, Eye movement disorder, Fall
Clinical narrative: Approx. 0850 gave patient Hep A plus Hep B vaccine to (R) upper arm and after 2nd shot given noticed that patient's eyes began to roll to back of head and she began to fall to (L) out of chairs. I immediately grabbed her and called for help from other coworkers. B/P 8:57 AM 90/60. B/P 10 AM 112/72. 08 APR 2018 Approximately around 09:00 patient received Hep A vaccine AC9F4 (Lot) 12/14/19 (EX) to (R) upper arm and Hep B vaccine 77H3M (Lot) 7/13/19 (Ex) to (R) upper arm. Within 30-60 seconds after receiving vaccines, patient lost consciousness with bilateral lower leg stiffness, bilateral arm stiffness, jaw clinched, and decreased airway sounds "Snoring -gasping". This reporting nurse tilted patient's head back and stabilized to increase open airway. Episode lasted approximately 1 minute. Postictal period (1-3 minutes) patient was confused, unable to communicate, blank stare, with white color to face upon consciousness. After 3 minutes patient was oriented x 3, color returned, and back to her normal baseline. EOR.
Age: 26.0
Sex: F
Vaccine: HEP, HEPA
Symptoms: Loss of consciousness, Musculoskeletal stiffness, Pallor, Postictal state, Snoring
Clinical narrative: Approx. 0850 gave patient Hep A plus Hep B vaccine to (R) upper arm and after 2nd shot given noticed that patient's eyes began to roll to back of head and she began to fall to (L) out of chairs. I immediately grabbed her and called for help from other coworkers. B/P 8:57 AM 90/60. B/P 10 AM 112/72. 08 APR 2018 Approximately around 09:00 patient received Hep A vaccine AC9F4 (Lot) 12/14/19 (EX) to (R) upper arm and Hep B vaccine 77H3M (Lot) 7/13/19 (Ex) to (R) upper arm. Within 30-60 seconds after receiving vaccines, patient lost consciousness with bilateral lower leg stiffness, bilateral arm stiffness, jaw clinched, and decreased airway sounds "Snoring -gasping". This reporting nurse tilted patient's head back and stabilized to increase open airway. Episode lasted approximately 1 minute. Postictal period (1-3 minutes) patient was confused, unable to communicate, blank stare, with white color to face upon consciousness. After 3 minutes patient was oriented x 3, color returned, and back to her normal baseline. EOR.
Age: 26.0
Sex: F
Vaccine: HEP, HEPA
Symptoms: Staring
Clinical narrative: Approx. 0850 gave patient Hep A plus Hep B vaccine to (R) upper arm and after 2nd shot given noticed that patient's eyes began to roll to back of head and she began to fall to (L) out of chairs. I immediately grabbed her and called for help from other coworkers. B/P 8:57 AM 90/60. B/P 10 AM 112/72. 08 APR 2018 Approximately around 09:00 patient received Hep A vaccine AC9F4 (Lot) 12/14/19 (EX) to (R) upper arm and Hep B vaccine 77H3M (Lot) 7/13/19 (Ex) to (R) upper arm. Within 30-60 seconds after receiving vaccines, patient lost consciousness with bilateral lower leg stiffness, bilateral arm stiffness, jaw clinched, and decreased airway sounds "Snoring -gasping". This reporting nurse tilted patient's head back and stabilized to increase open airway. Episode lasted approximately 1 minute. Postictal period (1-3 minutes) patient was confused, unable to communicate, blank stare, with white color to face upon consciousness. After 3 minutes patient was oriented x 3, color returned, and back to her normal baseline. EOR.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: We saw her on 6/28/17, 2 days after receiving vaccine PREVNAR 13. 6 cm (R) upper arm red/sore with shoulder pain.
Age: 1.0
Sex: M
Vaccine: FLUX, HEPA, MMR, PNC13
Symptoms: Seizure
Clinical narrative: Seizures noted night of immunization day. ER. No showed EEG appt.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Back pain, Insomnia, Loss of consciousness, Neck pain
Clinical narrative: After vaccine, soreness whole body, back neck, pass out 2-3 times a day weak, months o f this after vaccine, no sleep, nerves in feet, hands sore, nerves jumping 24/7 told doctor, no follow up, I need physical. I need checked up  follow up healthcare nobody will follow up on these development they say nothing wrong with vaccine I say something else.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity
Clinical narrative: After vaccine, soreness whole body, back neck, pass out 2-3 times a day weak, months o f this after vaccine, no sleep, nerves in feet, hands sore, nerves jumping 24/7 told doctor, no follow up, I need physical. I need checked up  follow up healthcare nobody will follow up on these development they say nothing wrong with vaccine I say something else.
Age: 3.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Cellulitis, Chills, Cough, Food aversion, Irritability
Clinical narrative: Fever, Chills, Cough, Irritability, Hives, Cellulitis. Friday-4/6/18 Fever, Cough, Lethargy. Saturday-4/7/18 Fever, Cough, Irritability, Hives. Sunday-4/8/18 Fever, Chills, Aversion to Food, Cough, Irritability, Cellulitis. Monday-4/9/18 Fever, Lethargy, Cellulitis.
Age: 3.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Lethargy, Pyrexia, Urticaria
Clinical narrative: Fever, Chills, Cough, Irritability, Hives, Cellulitis. Friday-4/6/18 Fever, Cough, Lethargy. Saturday-4/7/18 Fever, Cough, Irritability, Hives. Sunday-4/8/18 Fever, Chills, Aversion to Food, Cough, Irritability, Cellulitis. Monday-4/9/18 Fever, Lethargy, Cellulitis.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Erythema, Inflammation, Skin warm
Clinical narrative: Mother reported redness, inflammation, and warm to touch to Left arm started on 4/4/2018 at the evening hours. Mother started applying BENADRYL to site as well as BENADRYL orally along with ice packs to area. School nurse made assessment of area on 4/5/2018 and noticed the redness to area with inflammation and warm to touch approximately 19 to 20 cm. circumference which was localized to the left arm. At this time nurse refer child to MD. Child was absent from school on 4/6/2018. Teleconference with mother stated following recommendations from an MD in another country. 4/9/2018 nurse made assessment of left arm, and noticed no redness, no swelling and skin temperature WNL.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Right upper arm is warm, slightly reddened and slightly tender, about 3 cm.
Age: 19.0
Sex: F
Vaccine: TYP
Symptoms: Abdominal pain upper, Asthenia, Feeding disorder, Nervousness, Vomiting
Clinical narrative: Very Severe stomach pains, upper stomach area, radiating outward. Pain started approximately 12 hours after taking first dose. Severe pain lasted 9 hours. Also felt shaky and weak. Pain to a lesser extent for an additional 24 hours. Unable to eat for duration of pain. Severe vomiting 12 hours after first dose. Stopped taking medicine, rested, didn't eat, stayed hydrated with sips of water.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Atrial fibrillation, Erythema, Feeling cold, Headache, Hypoaesthesia
Clinical narrative: Pt reported following adverse events-couldn't raise arm; lg lump (10-12 cm); second finger of left hand numb (could not bend it); pain- level 6; extreme redness; flu like sx; headache; intervals of freezing/fever (100.2). Also admitted to hospital 5 days later for AF possibly related.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Mass, Mobility decreased, Pain, Pyrexia
Clinical narrative: Pt reported following adverse events-couldn't raise arm; lg lump (10-12 cm); second finger of left hand numb (could not bend it); pain- level 6; extreme redness; flu like sx; headache; intervals of freezing/fever (100.2). Also admitted to hospital 5 days later for AF possibly related.
Age: 0.75
Sex: M
Vaccine: HEP
Symptoms: Crying, Diet refusal, Influenza virus test negative, Irritability, Oropharyngeal pain
Clinical narrative: High Fever: Patient began running 102 fever 2 hours after vaccine. Fever spiked to 104.3 called Dr and they said to treat with MOTRIN and TYLENOL every 4 hrs. Fever would not come lower than 102. Irritability. Refused to eat baby food/table food. Stomach felt hard like it hurt him. Screaming/crying fits like he was in pain. These would last 15-30 minutes nothing to console him. He had NEVER done this before.
Age: 0.75
Sex: M
Vaccine: HEP
Symptoms: Pain, Pyrexia, Screaming, Streptococcus test positive
Clinical narrative: High Fever: Patient began running 102 fever 2 hours after vaccine. Fever spiked to 104.3 called Dr and they said to treat with MOTRIN and TYLENOL every 4 hrs. Fever would not come lower than 102. Irritability. Refused to eat baby food/table food. Stomach felt hard like it hurt him. Screaming/crying fits like he was in pain. These would last 15-30 minutes nothing to console him. He had NEVER done this before.
Age: 30.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Patient in to the clinic on 4/9/18 to report a reaction to a vaccine.  Received a Varicella and MMR vaccine on 4/6/18 in the PM. States the reaction started on 4/7/18 in the PM. Back of right arm where the varicella vaccine had been given had localized swelling, redness, and itching. Denies any other complaints. The back of the right upper arm has redness and mild swelling and itching. Instructed the patient that this is a common side effect of vaccination and should subside within a few days. She did not seek out any treatment. Instructed to apply a cool compress to area. Instructed to call her MD/seek medical care if rash were to worsen or not subside. She verbalized her understanding.
Age: 67.0
Sex: F
Vaccine: FLU4, PNC10, TDAP
Symptoms: Condition aggravated, Dyskinesia, Erythema, Feeling hot, Gait disturbance
Clinical narrative: PPSV - I just endured. There was no treatment. The extreme pain in both arms went on for up to 3 wks following vaccine always started in evening and went throughout night. I was sleep deprived. My arms also jerked as the violent pains kept attacking also gout in limbs (legs) was activated, extreme swelling and redness very difficult to walk and bath. I did need to try and move it seemed to help arms involuntarily jerked the entire time. Itching  I felt hot. TDAP - started very fast first evening awful violent pain jerking itching redness; just the one night. But so extreme gout started in legs feet 2 weeks. The first vaccine doctor thought possibly caused only by gout  second vaccine - I knew was caused by vaccine same day. Lasted one day. Activate gout.
Age: 67.0
Sex: F
Vaccine: FLU4, PNC10, TDAP
Symptoms: Gout, Insomnia, Pain in extremity, Pruritus, Swelling
Clinical narrative: PPSV - I just endured. There was no treatment. The extreme pain in both arms went on for up to 3 wks following vaccine always started in evening and went throughout night. I was sleep deprived. My arms also jerked as the violent pains kept attacking also gout in limbs (legs) was activated, extreme swelling and redness very difficult to walk and bath. I did need to try and move it seemed to help arms involuntarily jerked the entire time. Itching  I felt hot. TDAP - started very fast first evening awful violent pain jerking itching redness; just the one night. But so extreme gout started in legs feet 2 weeks. The first vaccine doctor thought possibly caused only by gout  second vaccine - I knew was caused by vaccine same day. Lasted one day. Activate gout.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Erythema, Headache, Injection site pain, Pain
Clinical narrative: Mild headache - 3 days, Chills - 2 days, evening hours, Extreme pain - 2 days, Dull ache - 5 days Redness - size of half dollar for 3 days and increased to an area 4-5 times that size for 2 days still present but is lightening and have minor itching. This shot was not given in the deltoid area given in the side of my upper arm about 4? below my shoulder felt like a knife when it was injected.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Product administered at inappropriate site, Pruritus
Clinical narrative: Mild headache - 3 days, Chills - 2 days, evening hours, Extreme pain - 2 days, Dull ache - 5 days Redness - size of half dollar for 3 days and increased to an area 4-5 times that size for 2 days still present but is lightening and have minor itching. This shot was not given in the deltoid area given in the side of my upper arm about 4? below my shoulder felt like a knife when it was injected.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Chills, Erythema, Fatigue, Headache
Clinical narrative: Felt all side effects listed on the CDC website; tired, achy, chills, headache, nausea, stomach pain, sore arm and redness. Side effects lingered for about 1 week and arm is still sore.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pain, Pain in extremity
Clinical narrative: Felt all side effects listed on the CDC website; tired, achy, chills, headache, nausea, stomach pain, sore arm and redness. Side effects lingered for about 1 week and arm is still sore.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site urticaria
Clinical narrative: Mother called on 04/09/2018 to report patient had a reaction the day after immunizations were given. Mother stated there was a large, red whelp on the right arm where the MENACTRA was given. Mother gave 2 doses of BENADRYL (one in the AM and one in the PM) and gave TYLENOL throughout the day. The area started getting smaller the 3rd day and no BENADRYL was given.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in jaw
Clinical narrative: Jaw pain left side.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Body temperature increased, Chills, Headache, Heart rate increased
Clinical narrative: Pt contacted provider via pt email. Pt received vaccine at approximately 1030 am. reaction came on suddenly at 1130 pm. Sx included severe headache, weakness, chattering of teeth, rapid heart beat and "felt like temp of 105."
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus
Clinical narrative: Deep itchiness unable to relieve via scratching beginning within minutes of vaccination and lasting for at least 5 days and resolved by taking TYLENOL. Over the last 2 days.
Age: 71.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Fatigue, Headache, Myalgia, Pruritus, Rash
Clinical narrative: Patient received SHINGRIX and PREVNAR 13 on 3/38/18. Next day pt felt "exhausted", had severe itching on back between shoulder blades and upper torso between breasts. Had slight headache and muscle pain. Visible rash on torso.
Age: 89.0
Sex: F
Vaccine: VARZOS
Symptoms: Eye pruritus, Eyelid rash, Intraocular pressure increased, Ocular hyperaemia, Ophthalmic herpes zoster
Clinical narrative: I now have shingles of the eye from the shot itches, rash, and blood shot. Pressure of my eye very high. I use Timodol, Brimonidine, Latanoprost. Nothing is helping. I don't want to lose my eyesight although vision risk. I may have laser treatment for high pressure. My next eye.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Swelling, redness and pain.
Sex: U
Vaccine: HIBV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a identifiable patient. The patient's medical history, concurrent condition and concomitant medications were not reported. On 19-SEP-2017, the patient was vaccinated with PEDVAXHIB dose 1 from lot number N012920 expiry date 07-FEB-2020 for prophylaxis. On 09-OCT-2017, the patient received second dose of PEDVAXHIB (lot number and expiration date were unknown by reporter). No adverse effects were reported. No product quality complaint was involved.
Age: 2.0
Sex: F
Vaccine: DTAP, HEPA, MMRV
Symptoms: Cough, Pyrexia, Rhinorrhoea, Vomiting
Clinical narrative: Per the child mother her daughter had a fever of 102.0 F, vomiting, snotty nose and coughing. Parent took child to her pediatrician prior to calling the Health Department on 3-29-18. Per Mom her pediatrician stated the child received too many shots and should only have received one. Mom did not vocalized which injection the child should have received. Parent has been alternating with TYLENOL/MOTRIN to treat the fever.
Sex: U
Vaccine: VARZOS
Symptoms: Asthenia, Fatigue, Feeling abnormal, Pain in extremity
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of pain in arm in a patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm, feeling bad, weakness and fatigue. On an unknown date, the outcome of the pain in arm was unknown and the outcome of the feeling bad, weakness and fatigue were recovered/resolved. It was unknown if the reporter considered the pain in arm, feeling bad, weakness and fatigue to be related to SHINGRIX. Additional information was provided as follows: The patient's demographic details were unknown. The age at vaccination was not reported. The reporter stated that the patient received SHINGRIX at a pharmacy. It was reported that the patient's arm was not as sore and was like Tetanus pain. However, the patient felt bad in general for almost 30 days with weakness and fatigue. The reporter did not agree to follow up. This case was linked with US2018GSK054702, reported by the same reporter.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 63-year-old male patient who received SHINGRIX. On 28th March 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 29th March 2018, 1 days after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was not recovered/not resolved. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were reported as follows: The patient was reporter's boyfriend or partner. The patient experienced the injection site reaction. This case has been linked with case US2018055921, reported by the same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Musculoskeletal disorder, Pain in extremity
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of pain in arm in a patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional information was provided as follows: The patient's demographic details were unknown. The age at vaccination was not reported. The reporter stated that the patient received SHINGRIX at a pharmacy. The patient complained of arm being so painful that it was useless for 24 hours then the pain slowly faded away. The reporter did not agree to follow up. This case was linked with US2018GSK054705, reported by the same reporter.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Injection site pruritus, Injection site rash, Injection site warmth
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injected limb mobility decreased in a 61-year-old female patient who received SHINGRIX. Concomitant products included vitamin D, WELLBUTRIN, doxepin, fish oil, PROZAC and TOPAMAX. On 25th March 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 26th March 2018, 1 days after receiving SHINGRIX, the patient experienced injected limb mobility decreased, injection site itching, injection site rash and injection site warmth. On an unknown date, the outcome of the injected site mobility decreased was unknown and the outcome of the injection site itching, injection site rash and injection site warmth were not recovered/not resolved. It was unknown if the reporter considered the injected limb mobility decreased, injection site itching, injection site rash and injection site warmth to be related to SHINGRIX. Additional details were reported as follows: The patient reported the injection site reactions. The patient received the vaccine on left deltoid. The patient experienced difficulty moving arm, rash, itchy and hot to touch. On an unknown date the patient had planned to follow up with her physician. This case has been linked with case US2018055922, reported by the same reporter.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Allergy test, Angioedema, Urticaria
Clinical narrative: Patient started having symptoms of angioedema and hives in 6/17, has been difficult to control by allergy. Mom feels this is related to GARDASIL.
Age: 53.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Blood bilirubin normal, Blood calcium increased, Hepatic function abnormal
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of acute derangement of liver function in a 53-year-old female patient who received SHINGRIX. On 23rd March 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 26th March 2018, 3 days after receiving SHINGRIX, the patient experienced acute derangement of liver function. On 1st April 2018, the outcome of the acute derangement of liver function was recovered/resolved. The reporter considered the acute derangement of liver function to be probably related to SHINGRIX. Additional details were reported as follows: The healthcare professional reported that patient was not on any medication and did not have any medical conditions that could have contributed to this. On either 26th March 2018 or 27th March 2018, the patient had blood work drawn and liver derangements. The healthcare professional reported that these labs were all normal prior to the patient receiving the SHINGRIX vaccine. On 1st April 2018, the patient had the labs redrawn again and everything returned back to normal and was resolved. The reporter did not have lot number or expiration date.
Age: 53.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Blood alkaline phosphatase normal, Blood bilirubin normal, Blood calcium increased
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of acute derangement of liver function in a 53-year-old female patient who received SHINGRIX. On 23rd March 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 26th March 2018, 3 days after receiving SHINGRIX, the patient experienced acute derangement of liver function. On 1st April 2018, the outcome of the acute derangement of liver function was recovered/resolved. The reporter considered the acute derangement of liver function to be probably related to SHINGRIX. Additional details were reported as follows: The healthcare professional reported that patient was not on any medication and did not have any medical conditions that could have contributed to this. On either 26th March 2018 or 27th March 2018, the patient had blood work drawn and liver derangements. The healthcare professional reported that these labs were all normal prior to the patient receiving the SHINGRIX vaccine. On 1st April 2018, the patient had the labs redrawn again and everything returned back to normal and was resolved. The reporter did not have lot number or expiration date.
Age: 53.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Gamma-glutamyltransferase increased, Hypercalcaemia, Liver function test abnormal
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of acute derangement of liver function in a 53-year-old female patient who received SHINGRIX. On 23rd March 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 26th March 2018, 3 days after receiving SHINGRIX, the patient experienced acute derangement of liver function. On 1st April 2018, the outcome of the acute derangement of liver function was recovered/resolved. The reporter considered the acute derangement of liver function to be probably related to SHINGRIX. Additional details were reported as follows: The healthcare professional reported that patient was not on any medication and did not have any medical conditions that could have contributed to this. On either 26th March 2018 or 27th March 2018, the patient had blood work drawn and liver derangements. The healthcare professional reported that these labs were all normal prior to the patient receiving the SHINGRIX vaccine. On 1st April 2018, the patient had the labs redrawn again and everything returned back to normal and was resolved. The reporter did not have lot number or expiration date.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Blood bilirubin normal, Blood calcium increased, Hepatic function abnormal
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of hypercalcemia in a patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced hypercalcemia and derangement of liver function tests. On an unknown date, the outcome if the hypercalcemia and derangement of liver function tests were unknown. It was unknown if the reporter considered the hypercalcemia and derangement of liver function tests to be related to SHINGRIX. Additional details were provided as follows: This query came into Medical information as a webform. The age at vaccination was not reported. The patient's blood alkaline phosphatase (ALP) was 113, aspartate aminotransferase (AST) was 69, alanine aminotransferase (ALT) was 179 gamma-glutamyltransferase (GGT) was 105, bilirubin was normal and he had hypercalcemia. The healthcare professional was contacted however was unable to reach.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Blood alkaline phosphatase normal, Blood bilirubin normal, Blood calcium increased
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of hypercalcemia in a patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced hypercalcemia and derangement of liver function tests. On an unknown date, the outcome if the hypercalcemia and derangement of liver function tests were unknown. It was unknown if the reporter considered the hypercalcemia and derangement of liver function tests to be related to SHINGRIX. Additional details were provided as follows: This query came into Medical information as a webform. The age at vaccination was not reported. The patient's blood alkaline phosphatase (ALP) was 113, aspartate aminotransferase (AST) was 69, alanine aminotransferase (ALT) was 179 gamma-glutamyltransferase (GGT) was 105, bilirubin was normal and he had hypercalcemia. The healthcare professional was contacted however was unable to reach.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Gamma-glutamyltransferase increased, Hypercalcaemia, Liver function test abnormal
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of hypercalcemia in a patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced hypercalcemia and derangement of liver function tests. On an unknown date, the outcome if the hypercalcemia and derangement of liver function tests were unknown. It was unknown if the reporter considered the hypercalcemia and derangement of liver function tests to be related to SHINGRIX. Additional details were provided as follows: This query came into Medical information as a webform. The age at vaccination was not reported. The patient's blood alkaline phosphatase (ALP) was 113, aspartate aminotransferase (AST) was 69, alanine aminotransferase (ALT) was 179 gamma-glutamyltransferase (GGT) was 105, bilirubin was normal and he had hypercalcemia. The healthcare professional was contacted however was unable to reach.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Joint swelling, Neurological symptom, Paraesthesia
Clinical narrative: Patient got neurologic symptoms feeling like she got electrified and her joints were swollen and painful. She couldn't even grab a phone. Starting the next morning and getting better over 3 days but she still feels pain and her joints were swollen. She called her PCP and explained how she was feeling and her MD said those symptoms were idiosyncratic effects from vaccine not related to fibromyalgia.
Age: 1.83
Sex: F
Vaccine: VARCEL
Symptoms: Lethargy, Pain, Pyrexia, Screaming
Clinical narrative: Similar episode our daughter had after her 2 month well visit and shots. Report #136105 - Screaming due to pain, 105 fever, lethargic for the following day.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site discomfort, Injection site pain, Pain
Clinical narrative: I experienced severe soreness in the muscles at and around the injection site, beginning about two hours after the vaccine was administered. This discomfort worsened during the next 24 hours. The site was painful to touch, as was lifting my arm. I experienced chills, body aches, and a dull headache during that first night (approximately 12 hours after the injection), and upon waking found I had a fever of 101 degrees. The fever slowly diminished over the next 24 hours, and the body aches lessened as well. By about 48 hours later, I still had some soreness at the injection site, but it had lessened substantially, and the other symptoms had resolved.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: I experienced severe soreness in the muscles at and around the injection site, beginning about two hours after the vaccine was administered. This discomfort worsened during the next 24 hours. The site was painful to touch, as was lifting my arm. I experienced chills, body aches, and a dull headache during that first night (approximately 12 hours after the injection), and upon waking found I had a fever of 101 degrees. The fever slowly diminished over the next 24 hours, and the body aches lessened as well. By about 48 hours later, I still had some soreness at the injection site, but it had lessened substantially, and the other symptoms had resolved.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature increased, Headache, Myalgia, Nausea
Clinical narrative: Headache, muscle pain, 102 degree temperature for approximately 12 hours. Nausea for 2 hours.