chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Asthenia, Blood test, Chronic inflammatory demyelinating polyradiculoneuropathy, Hypoaesthesia, Immunoglobulin therapy
Clinical narrative: Adverse Events: Numbness in both hands and both feet. Lower body weakness. Required walking with cane. Diagnosis - Chronic Inflammatory Demyelinating Polyneuropathy (Possible Guillain Barre) Treatment: IVIG Outcome: Modest improvement after first treatment of IVIG. After second round complete reversal of any progress made.
Age: 66.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Nerve conduction studies, Nuclear magnetic resonance imaging, Walking aid user
Clinical narrative: Adverse Events: Numbness in both hands and both feet. Lower body weakness. Required walking with cane. Diagnosis - Chronic Inflammatory Demyelinating Polyneuropathy (Possible Guillain Barre) Treatment: IVIG Outcome: Modest improvement after first treatment of IVIG. After second round complete reversal of any progress made.
Age: 0.33
Sex: M
Vaccine: UNK
Symptoms: Brain scan normal, Dyskinesia, Seizure
Clinical narrative: He got his shots very early in the morning. By night he was having seizures. Went to ER. They called it an "abnormal movement" and charged me 30 grand in brain scans and sent us home.
Age: 57.0
Sex: M
Vaccine: BCG
Symptoms: Injection site abscess
Clinical narrative: Patient received this prior to a trip, the patient reported an abscess at the site.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Rash, Urticaria
Clinical narrative: Rash and hives over upper body.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling abnormal, Hypoaesthesia
Clinical narrative: Numbness/weird feeling along side of body: same side vaccine was given on (left). Resolved in about 15 min. and pt. left pharmacy.
Age: 16.0
Sex: M
Vaccine: FLU4, MENB, MNQ
Symptoms: Back pain, C-reactive protein increased, Chills, Culture urine negative, Decreased appetite
Clinical narrative: He started with tactile fever, severe body ache, chills, intermittent severe headache, dizziness, nauseous and decrease appetite right after he received his immunizations, TRUMENBA, MCV4 and FLULAVAL. The following day his symptoms worsened, he started with lower back pain, dysuria and increased urination, he was urinating every 30 min for 12 hrs. His headache and back pain worsened. Symptoms: fever, headache, severe body aches, dizziness, nauseous, lower back pain, increased urination (every 30 min for 12 hrs), dysuria: x 3 days.
Age: 16.0
Sex: M
Vaccine: FLU4, MENB, MNQ
Symptoms: Dizziness, Dysuria, Full blood count normal, Headache, Metabolic function test normal
Clinical narrative: He started with tactile fever, severe body ache, chills, intermittent severe headache, dizziness, nauseous and decrease appetite right after he received his immunizations, TRUMENBA, MCV4 and FLULAVAL. The following day his symptoms worsened, he started with lower back pain, dysuria and increased urination, he was urinating every 30 min for 12 hrs. His headache and back pain worsened. Symptoms: fever, headache, severe body aches, dizziness, nauseous, lower back pain, increased urination (every 30 min for 12 hrs), dysuria: x 3 days.
Age: 16.0
Sex: M
Vaccine: FLU4, MENB, MNQ
Symptoms: Nausea, Pain, Pollakiuria, Pyrexia, Red blood cell sedimentation rate normal
Clinical narrative: He started with tactile fever, severe body ache, chills, intermittent severe headache, dizziness, nauseous and decrease appetite right after he received his immunizations, TRUMENBA, MCV4 and FLULAVAL. The following day his symptoms worsened, he started with lower back pain, dysuria and increased urination, he was urinating every 30 min for 12 hrs. His headache and back pain worsened. Symptoms: fever, headache, severe body aches, dizziness, nauseous, lower back pain, increased urination (every 30 min for 12 hrs), dysuria: x 3 days.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Body temperature increased, Rash erythematous, Seizure
Clinical narrative: 12/04/2017 given KINRIX Vaccine (L) thigh IM in office on 12/12/17 mom called to advise same night pt had high temp 104 with seizures. Broke out with red dots widened. Pt was taken to E.R. for eval.
Age: 26.0
Sex: F
Vaccine: HEP
Symptoms: Pain, Pain in extremity
Clinical narrative: 12/28/17 Employee stated she had arm pain post at least 2 weeks from administration of vaccines; still has occasional pain upon various movements.
Age: 49.0
Sex: F
Vaccine: FLUX
Symptoms: Drug administered at inappropriate site, Injection site reaction, Neuralgia
Clinical narrative: Given incorrect location - too anterior on upper arm leading to nerve pain that follows brachial plexus distribution.
Age: 78.0
Sex: M
Vaccine: FLU4
Symptoms: Asthenia, Condition aggravated
Clinical narrative: 78 year old white male with PMH significant for HTN, COPD, OSA, AFib, chronic pain, neuropathy, anemia, recent fall who reported feeling progressively weaker since receiving influenza vaccine on 10/11/17 to his PCP on 12/1/17. Patient reported concern at that time that the vaccine was the cause of his increase in weakness. Of not, Patient with bilateral lower limb weakness prior to administration of influenza vaccine.
Age: 26.0
Sex: M
Vaccine: FLU4, HEP
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: 12/28/17 Hepatitis B vaccine pulled from private stock which was pediatric dose and given to patient. (GSK) GlaxoSmithKline called. Summary of Immunogenicity and Safety of 10 mcg dose of ENGERIX B in Adults. Health Commissioner notified. No treatment needed.
Age: 0.5
Sex: U
Vaccine: HEP, HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect; improperly stored vaccine adminstered; This spontaneous report was received from a medical assistant regarding an unspecified number of patients of unknown age and gender. The patients' medical history, concomitant medication and concurrent conditions were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) from lot # M040423 with expiry: 03-JUL-2019 (dosing details not reported) for prophylaxis. No adverse effects reported. The vaccine was exposed to a temperature excursion of 35 degree Fahrenheit for 20 minutes. It also had 3 previous temperature excursion of 35 degree Fahrenheit for 20 minutes each. The temperature excursion was detected by digital data logger.   This is one of the three reports received from the same reporter.  All telephone attempts to obtain follow-up information have been unsuccessful.  This case was previously considered valid but per current process it was determined to be non-valid as no patient identifier.  Follow up information was received from a medical assistant. The patient's identifiers were provided. This report refers to a 6-months-old patient of unknown gender, who on 11-JUL-2017 was vaccinated with a dose of improperly stored hepatitis b vaccine (recombinant) (RECOMBIVAX HB) from lot # M040423 with expiry: 03-JUL-2019 for prophylaxis.  The reporter confirmed the temperature excursions on 12-JUN-2017at 8:00 am, reported previously, however it was also reported, that the temperature dropped down to 35 degree Fahrenheit for about 15 minutes. The minimum temperature was reported as 35 degree Fahrenheit and maximum temperature 43 degree Fahrenheit, room temperature when discovered was 72 degree Fahrenheit. The reporter contacted manufacturer, they were able to use vaccines, she adjusted the temperature on the storage unit, there had been no other problems.   This is one of a few reports received from the same reporter.; Sender's Comments:  US-009507513-1707USA005936: US-009507513-1707USA007097: US-009507513-1712USA010535: US-009507513-1712USA010536: US-009507513-1707USA007096:
Age: 0.5
Sex: U
Vaccine: HEP, HEP
Symptoms: Product storage error
Clinical narrative: No adverse effect; improperly stored vaccine adminstered; This spontaneous report was received from a medical assistant regarding an unspecified number of patients of unknown age and gender. The patients' medical history, concomitant medication and concurrent conditions were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) from lot # M040423 with expiry: 03-JUL-2019 (dosing details not reported) for prophylaxis. No adverse effects reported. The vaccine was exposed to a temperature excursion of 35 degree Fahrenheit for 20 minutes. It also had 3 previous temperature excursion of 35 degree Fahrenheit for 20 minutes each. The temperature excursion was detected by digital data logger.   This is one of the three reports received from the same reporter.  All telephone attempts to obtain follow-up information have been unsuccessful.  This case was previously considered valid but per current process it was determined to be non-valid as no patient identifier.  Follow up information was received from a medical assistant. The patient's identifiers were provided. This report refers to a 6-months-old patient of unknown gender, who on 11-JUL-2017 was vaccinated with a dose of improperly stored hepatitis b vaccine (recombinant) (RECOMBIVAX HB) from lot # M040423 with expiry: 03-JUL-2019 for prophylaxis.  The reporter confirmed the temperature excursions on 12-JUN-2017at 8:00 am, reported previously, however it was also reported, that the temperature dropped down to 35 degree Fahrenheit for about 15 minutes. The minimum temperature was reported as 35 degree Fahrenheit and maximum temperature 43 degree Fahrenheit, room temperature when discovered was 72 degree Fahrenheit. The reporter contacted manufacturer, they were able to use vaccines, she adjusted the temperature on the storage unit, there had been no other problems.   This is one of a few reports received from the same reporter.; Sender's Comments:  US-009507513-1707USA005936: US-009507513-1707USA007097: US-009507513-1712USA010535: US-009507513-1712USA010536: US-009507513-1707USA007096:
Age: 66.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Injected limb mobility decreased, Injection site pain, Injection site reaction, Muscle twitching, Pruritus
Clinical narrative: 9-29-17 I had the flu shot in the left shoulder. At first it was normal. 10-1-17 the shoulder and upper shoulder near the neck and arm started to feel muscle and joint pain and the left arm was twitching that day but stopped the next day. The other pains was still there. I called pharmacy and they took a report over the phone, sent it to the drug company. About 10-14 or 15th the pain in the shoulder joint was still there, making it harder to do everyday things, like putting on jackets, moving things, getting out of bed. 10-30-17 I seen Dr and told him about the pain and limited movement from the shot. He checked the shoulder and neck muscles and said they seemed tight and to try heat and ASPERCREME with LIDOCAINE, and ibuprofen, which helped, but I still have pain in the neck and shoulder muscles and sometimes headaches coming up the back of my neck. If I push on the point of the Flu shot it feels like a bruise. 12-27-17. I have a appointment 1-9-18 with Dr about this and other tests. I never had adverse events with vaccine before, I had the shots in the right arm at other pharmacies.
Age: 66.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Skin irritation
Clinical narrative: 9-29-17 I had the flu shot in the left shoulder. At first it was normal. 10-1-17 the shoulder and upper shoulder near the neck and arm started to feel muscle and joint pain and the left arm was twitching that day but stopped the next day. The other pains was still there. I called pharmacy and they took a report over the phone, sent it to the drug company. About 10-14 or 15th the pain in the shoulder joint was still there, making it harder to do everyday things, like putting on jackets, moving things, getting out of bed. 10-30-17 I seen Dr and told him about the pain and limited movement from the shot. He checked the shoulder and neck muscles and said they seemed tight and to try heat and ASPERCREME with LIDOCAINE, and ibuprofen, which helped, but I still have pain in the neck and shoulder muscles and sometimes headaches coming up the back of my neck. If I push on the point of the Flu shot it feels like a bruise. 12-27-17. I have a appointment 1-9-18 with Dr about this and other tests. I never had adverse events with vaccine before, I had the shots in the right arm at other pharmacies.
Age: 66.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Headache, Injection site bruising, Injection site joint pain, Injection site pain, Loss of personal independence in daily activities
Clinical narrative: 9-29-17 I had the flu shot in the left shoulder. At first it was normal. 10-1-17 the shoulder and upper shoulder near the neck and arm started to feel muscle and joint pain and the left arm was twitching that day but stopped the next day. The other pains was still there. I called pharmacy and they took a report over the phone, sent it to the drug company. About 10-14 or 15th the pain in the shoulder joint was still there, making it harder to do everyday things, like putting on jackets, moving things, getting out of bed. 10-30-17 I seen Dr and told him about the pain and limited movement from the shot. He checked the shoulder and neck muscles and said they seemed tight and to try heat and ASPERCREME with LIDOCAINE, and ibuprofen, which helped, but I still have pain in the neck and shoulder muscles and sometimes headaches coming up the back of my neck. If I push on the point of the Flu shot it feels like a bruise. 12-27-17. I have a appointment 1-9-18 with Dr about this and other tests. I never had adverse events with vaccine before, I had the shots in the right arm at other pharmacies.
Age: 66.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Mobility decreased, Muscle tightness, Muscle twitching, Neck pain
Clinical narrative: 9-29-17 I had the flu shot in the left shoulder. At first it was normal. 10-1-17 the shoulder and upper shoulder near the neck and arm started to feel muscle and joint pain and the left arm was twitching that day but stopped the next day. The other pains was still there. I called pharmacy and they took a report over the phone, sent it to the drug company. About 10-14 or 15th the pain in the shoulder joint was still there, making it harder to do everyday things, like putting on jackets, moving things, getting out of bed. 10-30-17 I seen Dr and told him about the pain and limited movement from the shot. He checked the shoulder and neck muscles and said they seemed tight and to try heat and ASPERCREME with LIDOCAINE, and ibuprofen, which helped, but I still have pain in the neck and shoulder muscles and sometimes headaches coming up the back of my neck. If I push on the point of the Flu shot it feels like a bruise. 12-27-17. I have a appointment 1-9-18 with Dr about this and other tests. I never had adverse events with vaccine before, I had the shots in the right arm at other pharmacies.
Age: 67.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Malaise, Nasal congestion, Pyrexia
Clinical narrative: Initial unsolicited report received from a pharmacist on 02-Nov-2017. This case involves a 67-year-old female patient, who was vaccinated with a dose of 0.5 ml of FLUZOE HIGH-DOSE once (batch number: UI871AB) expiry date, dose in series and administration site were not reported) via intramuscular route on 31-Oct-2017 and again, received on 02-Nov-2017 (Batch number, expiry date, dose, dose in series, route and administration site were not reported). The patient's medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient's developed irritation at injection site, mild fever, muscle aches, and sinus congestion. It was also a case of actual medication error due to extra dose administered. The patient was previously vaccinated with FLUZONE HIGH-DOSE on an unspecified day (last year) and did not any reaction. Laboratory data was not reported and corrective treatment was none. Outcome of the events were not reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module of the Good Pharmacovigilance Practices. List of documents held by sender: none.
Age: 67.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Extra dose administered, Injection site irritation, Myalgia, Pyrexia, Sinus congestion
Clinical narrative: Initial unsolicited report received from a pharmacist on 02-Nov-2017. This case involves a 67-year-old female patient, who was vaccinated with a dose of 0.5 ml of FLUZOE HIGH-DOSE once (batch number: UI871AB) expiry date, dose in series and administration site were not reported) via intramuscular route on 31-Oct-2017 and again, received on 02-Nov-2017 (Batch number, expiry date, dose, dose in series, route and administration site were not reported). The patient's medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient's developed irritation at injection site, mild fever, muscle aches, and sinus congestion. It was also a case of actual medication error due to extra dose administered. The patient was previously vaccinated with FLUZONE HIGH-DOSE on an unspecified day (last year) and did not any reaction. Laboratory data was not reported and corrective treatment was none. Outcome of the events were not reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module of the Good Pharmacovigilance Practices. List of documents held by sender: none.
Age: 77.0
Sex: M
Vaccine: FLU4, PPV, FLUX, PPV
Symptoms: Discomfort, Injection site erythema, Injection site swelling, Pain in extremity, Peripheral swelling
Clinical narrative: This spontaneous report was received from a 77 year old male patient who was reporting on himself. The patient's medical history included autonomic nervous system imbalance, stent placement, vascular graft and aortic valve replacement. Patient's current conditions included allergy to amiodarone. On 29-NOV-2017, around noon, the patient was vaccinated with PNEUMOVAX 23 for prophylaxis (dose, route of administration, lot number and expiration date were not reported). On the same day, the patient was concomitantly vaccinated with a dose of an influenza virus vaccine (unspecified). Concomitant therapies included bisoprolol, clopidogrel bisulfate(PLAVIX), metformin and pravastatin. On 29-NOV-2017, by 18:00hs the patient experienced a little discomfort in the left arm and felt achy. On the same day, by 20:00hs the pain in the arm was excruciating, from 13 to 15 on a scale of 10. The patient reported that he had never felt that kind of pain. The pain kept the patient awake all night. On an unspecified date in November 2017, the patient experienced swelling from the shoulder to the wrist of his left arm; the arm was red and  tender to the touch . On 30-NOV-2017, the patient sought medical attention with physician's assistant. The patient self-medicated with acetaminophen (TYLENOL), taking six over eight hours, as reported. He got no relief. No laboratory diagnostics or studies performed.  The outcome of limb discomfort, tenderness, erythema, peripheral swelling and pain in extremity was reported as not recovered. The outcome of insomnia was unknown. The causal relationship between the aforementioned events and therapy with PNEUMOVAX 23 was not reported.  The patient had a history of allergy (hypersensitivity) while on prior therapy with aspirin (manufacturer unknown) (case #1712USA014489).; Sender's Comments:  US-009507513-1712USA014489:
Age: 77.0
Sex: M
Vaccine: FLU4, PPV, FLUX, PPV
Symptoms: Insomnia, Limb discomfort, Pain, Pain in extremity, Peripheral swelling
Clinical narrative: This spontaneous report was received from a 77 year old male patient who was reporting on himself. The patient's medical history included autonomic nervous system imbalance, stent placement, vascular graft and aortic valve replacement. Patient's current conditions included allergy to amiodarone. On 29-NOV-2017, around noon, the patient was vaccinated with PNEUMOVAX 23 for prophylaxis (dose, route of administration, lot number and expiration date were not reported). On the same day, the patient was concomitantly vaccinated with a dose of an influenza virus vaccine (unspecified). Concomitant therapies included bisoprolol, clopidogrel bisulfate(PLAVIX), metformin and pravastatin. On 29-NOV-2017, by 18:00hs the patient experienced a little discomfort in the left arm and felt achy. On the same day, by 20:00hs the pain in the arm was excruciating, from 13 to 15 on a scale of 10. The patient reported that he had never felt that kind of pain. The pain kept the patient awake all night. On an unspecified date in November 2017, the patient experienced swelling from the shoulder to the wrist of his left arm; the arm was red and  tender to the touch . On 30-NOV-2017, the patient sought medical attention with physician's assistant. The patient self-medicated with acetaminophen (TYLENOL), taking six over eight hours, as reported. He got no relief. No laboratory diagnostics or studies performed.  The outcome of limb discomfort, tenderness, erythema, peripheral swelling and pain in extremity was reported as not recovered. The outcome of insomnia was unknown. The causal relationship between the aforementioned events and therapy with PNEUMOVAX 23 was not reported.  The patient had a history of allergy (hypersensitivity) while on prior therapy with aspirin (manufacturer unknown) (case #1712USA014489).; Sender's Comments:  US-009507513-1712USA014489:
Age: 77.0
Sex: M
Vaccine: FLU4, PPV, FLUX, PPV
Symptoms: Skin reaction, Tenderness
Clinical narrative: This spontaneous report was received from a 77 year old male patient who was reporting on himself. The patient's medical history included autonomic nervous system imbalance, stent placement, vascular graft and aortic valve replacement. Patient's current conditions included allergy to amiodarone. On 29-NOV-2017, around noon, the patient was vaccinated with PNEUMOVAX 23 for prophylaxis (dose, route of administration, lot number and expiration date were not reported). On the same day, the patient was concomitantly vaccinated with a dose of an influenza virus vaccine (unspecified). Concomitant therapies included bisoprolol, clopidogrel bisulfate(PLAVIX), metformin and pravastatin. On 29-NOV-2017, by 18:00hs the patient experienced a little discomfort in the left arm and felt achy. On the same day, by 20:00hs the pain in the arm was excruciating, from 13 to 15 on a scale of 10. The patient reported that he had never felt that kind of pain. The pain kept the patient awake all night. On an unspecified date in November 2017, the patient experienced swelling from the shoulder to the wrist of his left arm; the arm was red and  tender to the touch . On 30-NOV-2017, the patient sought medical attention with physician's assistant. The patient self-medicated with acetaminophen (TYLENOL), taking six over eight hours, as reported. He got no relief. No laboratory diagnostics or studies performed.  The outcome of limb discomfort, tenderness, erythema, peripheral swelling and pain in extremity was reported as not recovered. The outcome of insomnia was unknown. The causal relationship between the aforementioned events and therapy with PNEUMOVAX 23 was not reported.  The patient had a history of allergy (hypersensitivity) while on prior therapy with aspirin (manufacturer unknown) (case #1712USA014489).; Sender's Comments:  US-009507513-1712USA014489:
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Injection site rash
Clinical narrative: This spontaneous report was received from a pharmacist concerning a 60 year old female patient. Patient's current conditions included chronic obstructive pulmonary disease (COPD), asthma and nervous system disorder. The patient had allergy to codeine. The patient's medical history included herpes zoster. On 13-JUL-2017, the patient was vaccinated with ZOSTAVAX lot # N015628 with expiration date of 30-JUL-2018, subcutaneously as was recommended by physician (dose was not reported). Concomitant therapies included pravastatin, fluticasone furoate, vilanterol trifenatate(BREO), quetiapine fumarate, pantoprazole and gabapentin. On 15-JUL-2017, the patient developed a red rash on left upper arm (rash erythematous). On 24-NOV-2017 (it was reported that was unknown how long patient had rash), when an unknown physician diagnosed shingles (herpes zoster). On an unknown date, after, pharmacist saw same patient with rash upper left arm with lesions scabbed over. The patient sought medical attention and received unspecified treatment. There were no laboratory diagnostics or studies performed. The outcome of rash erythematous, herpes zoster and scab was reported as recovering. The causal relationship between the events and therapy with ZOSTAVAX were not reported. The patient had a history of allergy (hypersensitivity) while on prior therapy with simvastatin (ZOCOR). (case #1712USA014427).; Sender's Comments: US-009507513-1712USA014427:
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Rash erythematous, Scab
Clinical narrative: This spontaneous report was received from a pharmacist concerning a 60 year old female patient. Patient's current conditions included chronic obstructive pulmonary disease (COPD), asthma and nervous system disorder. The patient had allergy to codeine. The patient's medical history included herpes zoster. On 13-JUL-2017, the patient was vaccinated with ZOSTAVAX lot # N015628 with expiration date of 30-JUL-2018, subcutaneously as was recommended by physician (dose was not reported). Concomitant therapies included pravastatin, fluticasone furoate, vilanterol trifenatate(BREO), quetiapine fumarate, pantoprazole and gabapentin. On 15-JUL-2017, the patient developed a red rash on left upper arm (rash erythematous). On 24-NOV-2017 (it was reported that was unknown how long patient had rash), when an unknown physician diagnosed shingles (herpes zoster). On an unknown date, after, pharmacist saw same patient with rash upper left arm with lesions scabbed over. The patient sought medical attention and received unspecified treatment. There were no laboratory diagnostics or studies performed. The outcome of rash erythematous, herpes zoster and scab was reported as recovering. The causal relationship between the events and therapy with ZOSTAVAX were not reported. The patient had a history of allergy (hypersensitivity) while on prior therapy with simvastatin (ZOCOR). (case #1712USA014427).; Sender's Comments: US-009507513-1712USA014427:
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Discomfort, Enema administration, Haematochezia, Intussusception, Poor feeding infant
Clinical narrative: Intussusception. Patient presented to clinic due to poor feeding and apparent discomfort. Subsequently patient had bloody bowel movement in clinic and was immediately referred to local Emergency Department (Hospitalized x 24-48 hours, treated by enema).
Age: 10.0
Sex: F
Vaccine: FLUC4
Symptoms: Dizziness, Headache, Throat tightness
Clinical narrative: Headache, pressure in throat, dizziness.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient was vaccinated by the intramuscular route with ZOSTAVAX 19400 plaque-forming units (PFU) injection, lot # N020938, expiration date 31-JUL-2018 (dose was not reported) for prophylaxis. Other suspect therapies included sterile diluent (MERCK STERILE DILUENT) lot # N020938, expiration date 12-AUG-2019, (strength, dose, frequency, route of administration, indication were not reported). No adverse event was reported. The outcome of the event was unknown.
Sex: M
Vaccine: HPV9
Symptoms: Skin papilloma
Clinical narrative: This spontaneous report was received from a physician referring to a 17 year old male patient. The patient did not have any pertinent medical history or concomitant medications; allergies and drug reactions were unknown by the reporter. On 28-AUG-2017, the patient was vaccinated with his first dose of GARDASIL 9 intramuscular, frequency was not reported (lot # N013695, expiration date: 21-MAR-2017) for prophylaxis. In November 2017, it was reported that after the first shot, the patient experienced "planter warts". The patient received his second dose of GARDASIL 9 and "a week after", approximately in November 2017, experienced plantar warts again. It was unknown if the patient received treatment for the events or if there were laboratory diagnostic test performed. The outcome of plantar warts was unknown at the time of the report. The reporter mentioned that the patient would not be receiving the third shot of GARDASIL 9. The relatedness between plantar warts and GARDASIL 9 was not reported.
Sex: M
Vaccine: PPV
Symptoms: Influenza like illness, Pain, Swelling
Clinical narrative: This spontaneous report was received from a pharmacist concerning a 69 year old male patient. There was no information about the patient's concurrent conditions, medical history or concomitant medication. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (dose/frequency reported as 1 rod inserted) as recommended for patient over the age 65 (route of administration, lot number and expiration date were not reported). On an unknown date, following the vaccination, the patient experienced pain, swelling and flu like symptoms. The patient sought medical attention and was prescribed by his physician unspecified antibiotics for the adverse reactions. The outcome of pain, influenza like illness and swelling and the causal relationship between the events and therapy with PNEUMOVAX 23 were not reported.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Laboratory test, Pain in extremity, Tendonitis
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 68-year-old female patient. The patient had no concomitant medications, medical history and concurrent conditions. On 18-OCT-2017, the patient was vaccinated with a dose of PNEUMOVAX 23 injection, lot # 103820 with expiration date on 06-MAR-2019 (dose and route of administration were not reported). On 19-OCT-2017, the patient experienced bicipital tendonitis in her left shoulder and a moderate left arm pain which was severe at first, however at the time of the report it was mild and worsening at night, when the patient was lying and with movement. On 15-NOV-2017, a physician performed a shoulder test and a Hawkins test and both were negative. There was no evidence of muscle atrophy and no other muscle abnormalities. The events were treated since 11-DEC-2017, with a course of prednisone, which was ongoing at the time of the report. The relatedness between the events and PNEUMOVAX 23 was not reported.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 60-year-old female patient. The patient had allergy to penicillin and tramadol and no medical history. On 22-NOV-2017, the patient was vaccinated with a dose of ZOSTAVAX injection, lot # M041511 with expiration date on 08-JAN-2017. The dose of the vaccine was reconstituted with sterile diluent (MERCK) injection (dose, lot number and expiration date were not reported). Concomitant therapies included levothyroxine sodium (manufacturer unknown), lisinopril (manufacturer unknown) and famotidine (manufacturer unknown). On 01-DEC-2017, the patient developed a shingles rash and was diagnosed with a mild case of shingles. The patient sought medical attention at an unspecified primary care office and was prescribed valacyclovir as a treatment. The patient recovered from the event on an unknown date in December 2017. The relatedness between the event and ZOSTAVAX and sterile diluent (MERCK) was not reported.
Sex: U
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 38-year-old patient. No information regarding the patient's medical history, concurrent conditiond and concomitant medications was provided. On 13-DEC-2017, the patient was vaccinated with a dose of PROQUAD injection (dose, route of administralion, lot number and expiration date were not reported). The dose of the vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) injection (dose, route of administration, lot number and expiration date were not reported). No adverse effects were reported.; Sender's Comments: US-009507513-1712USA006863:
Sex: U
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 42-year-old patient. No information regarding the patient's medical history, concurrent conditiond and concomitant medications was provided. On 13-DEC-2017, the patient was vaccinated with a dose of PROQUAD injection (dose, route of administralion, lot number and expiration date were not reported). The dose of the vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) injection (dose, route of administration, lot number and expiration date were not reported). No adverse effects were reported. This is one of two reports received from the same source.; Sender's Comments: US-009507513-1712USA006857:
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from an unspecified reporter via a company representative and refers to a male patient of unknown age. The patient's concurrent conditions included diabetes mellitus and an unknown heart condition. The patient's medical history and concomitant therapies were not reported. Approximately in 2007 (also reported as "approximately 10 years ago"), the patient was vaccinated with a dose of ZOSTAVAX (concentration, dose, frequency, lot# and expiration date were not provided), to prevent shingles. On 18-DEC-2017, the patient was diagnosed with shingles. Therefore, the patient went to the Emergency Room and was treated with unknown pain medication and unknown antibiotic medication. At the time of reporting, the patient did not recover from herpes zoster. The reporter did not provide a causality assessment between ZOSTAVAX and herpes zoster.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 29-NOV-2017, the patient was vaccinated with VARIVAX improperly stored (dosage, route of administration and frequency were not reported) lot # M033214 and expiration date: 13-JUL-2018 indicated for prophylaxis, together with a sterile diluent (manufacturer unknown) lot#: N015632, expiration date: 18-FEB-2019. The vaccines did not have any previous temperature excursions not recorded by a data logger. The vaccines were stored in a temperature of -14C for 4 hours. There was no adverse effect reported. This is one of several reports from the same source (MARRS # 1712USA000496, MARRS # 1712USA013689). Sender's Comments: US-009507513-1712USA000496: US-009507513-1712USA013689.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. There was no information regarding the patient's medical history, concomitant medications, drug reactions and allergies provided. On 28-DEC-2017, the patient was vaccinated with expired dose of ROTATEQ, orally for prophylaxis, lot # M019708, expiration date 25-OCT-2017. No adverse effects were reported.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Fall, Hypotonia, Muscle twitching, Musculoskeletal stiffness
Clinical narrative: Several seconds after administering vaccination, patient became limp and fell forward onto this nurse. Patient was sat back up but fell forward again. No response from patient when being spoken to. Patient was laid back onto exam table when she became very stiff and began to twitch for approximately 10 seconds. When episode was complete, patient stated she had no recollection of what had happened. Dr. made aware of what had happened before examining the patient and giving the all clear for her to leave after the 15 minute window was up.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Abnormal behaviour, Electrocardiogram, Electroencephalogram, Hypotonia, Immediate post-injection reaction
Clinical narrative: Immediately following the vaccines, baby was lethargic and continued to be unusually extra sleepy all week. She had a head drop episode during that week and was fussy throughout. Acted unlike her usual very energetic self. 5 days post vaccines, she went limp for a brief period of time then 2 hours later she experienced a seizure during which she was limp. Called 911, she came around post-seizure, taken to ER, then was transferred to hospital. 2 weeks later she experienced another 3 seizures spaced out every other day. 2 weeks after that she experienced 6 seizures in a week (twice in one day on back to back days in addition to the other days).
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Irritability, Lethargy, Nuclear magnetic resonance imaging, Posture abnormal, Seizure
Clinical narrative: Immediately following the vaccines, baby was lethargic and continued to be unusually extra sleepy all week. She had a head drop episode during that week and was fussy throughout. Acted unlike her usual very energetic self. 5 days post vaccines, she went limp for a brief period of time then 2 hours later she experienced a seizure during which she was limp. Called 911, she came around post-seizure, taken to ER, then was transferred to hospital. 2 weeks later she experienced another 3 seizures spaced out every other day. 2 weeks after that she experienced 6 seizures in a week (twice in one day on back to back days in addition to the other days).
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Somnolence
Clinical narrative: Immediately following the vaccines, baby was lethargic and continued to be unusually extra sleepy all week. She had a head drop episode during that week and was fussy throughout. Acted unlike her usual very energetic self. 5 days post vaccines, she went limp for a brief period of time then 2 hours later she experienced a seizure during which she was limp. Called 911, she came around post-seizure, taken to ER, then was transferred to hospital. 2 weeks later she experienced another 3 seizures spaced out every other day. 2 weeks after that she experienced 6 seizures in a week (twice in one day on back to back days in addition to the other days).
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-valid spontaneous report was received from a medical assistant and refers to a unspecified amount of unspecified patients of unknown age and gender. The patients' pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. From 12-NOV-2017 to 05-DEC--2017, the patients were vaccinated with improperly stored doses of GARDASIL 9 injection ( strength, dose and route of administration were not reported) (lot # N004799 with expiration date on 15-NOV-2019) for prophylaxis. The temperature of excursion with GARDASIL 9 was from 0 to 1 degrees Celsius for 3 hours.There was no previous temperature excursion performed. The temperature of excursion was detected by a data logger. No adverse effects were reported.
Sex: U
Vaccine: RV5
Symptoms: Oral administration complication, Vomiting
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions and allergies were not reported. Information regarding concomitant therapies was not provided. On an unknown date, the patient was vaccinated with the first dose of ROTATEQ, orally for prophylaxis (dose, lot# and expiration date were not reported). According to the reporter, the patient vomited some dose of an ROTATEQ after administration. The outcome of the event was not reported. Causality assessement was not provided.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Rash, Streptococcus test
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 4-year-old male patient. The patient did not have any pertinent medical history, concomitant therapies and drug reactions or allergies. On 11-JAN-2017, the patient was vaccinated with a dose of M-M-R II (dose, route of administration, lot# and expiration date were not reported), VARIVAX (dose, route of administration, lot# and expiration date were not reported) and diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (dose, route of administration, indication, lot# and expiration date were not reported) without incident. On 11-DEC-2017, the patient was vaccinated with a dose of (therapy type: rHA) PROQUAD subcutaneously, lot#N022954 and expiration date: 19-FEB-2019 (dose was not reported) reconstituted with sterile diluent (lot# and expiration date were not reported) and QUADRACEL (dose, route of administration, indication, lot# and expiration date were not reported). On 14-DEC-2017, the patient developed a rash on face. Treatment was given for the event. Strep test was performed on an unknown date (results not provided). The patient sought medical attention - saw physician. The outcome of the event was reported as not recovered. The relatedness between the suspect therapies and the event was not reported.
Sex: U
Vaccine: HPVX
Symptoms: Adverse event
Clinical narrative: This spontaneous report as received from a consumer refers to a teenager patient of unknown gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On an unknown date, the patient was vaccinated with a dose of GARDASIL (dose, frequency, route of administration, lot# and expiration date were not reported) or a dose of GARDASIL 9 (dose, frequency, route of administration, lot# and expiration date were not reported). It was unknown if product was GARDASIL or GARDASIL 9. On an unknown date, the patient experienced adverse event unspecified. The outcome of adverse event was unknown. The relatedness between the adverse event and therapy with GARDASIL or GARDASIL was not reported. This is one of six reports received from the same source.; Sender's Comments: US-009507513-1712USA014392: US-009507513-1712USA014393: US-009507513-1712USA014394: US-009507513-1712USA014395: US-009507513-1712USA014396:
Age: 47.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician assistant and refers to a 47 year old patient of unknown gender. There was no information regarding the patient's medical history, concomitant medications, drug reactions and allergies provided. On 29-NOV-2017, the patient was vaccinated with PROQUAD, therapy type rHA, lot # M044575, expiration date 04-MAY-2018, for prophylaxis (dose and route of administration were not provided). Concomitant therapies included sterile diluent. The administered dose of PROQUAD was stored in the refrigerator from 18-OCT-2017, in temperature of 39 degrees Fahrenheit for 1008 hours (42 days). The call was because of digital data logger. There was no previous temperature excursion. No adverse effect was reported. This is one of a several reports received from the same reporter. Sender's Comments: US-009507513-1712USA009167.
Age: 6.0
Sex: M
Vaccine: DTAPIPV, HEPA, MMR, VARCEL
Symptoms: Injection site pruritus, Injection site rash, Pyrexia
Clinical narrative: As reported to reporter by child's guardian: Guardian  reports child had itchy rash, approximately 30mm in diameter, at site on left upper arm (where KINRIX was given), which began the night vaccine was given on 12/06/2017. The rash continued through the next day. Child also had a fever of 102, and temp was back to normal the next day. Guardian gave Ibuprofen (2 doses on evening of 12/06/2017 and 2 doses on 12/07/2017). Hydrocortisone cream was applied to rash x2 days. The guardian did not return to clinic where vaccine was given or take child to his doctor for evaluation of rash.
Age: 7.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Peripheral swelling, Skin warm, Tenderness
Clinical narrative: Patient came into our office the next day with redness and swelling from shoulder to elbow, with warmth and tenderness.
Age: 4.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant that was also an office manager concerning a 4 year old patient of unknown gender. There was no information about the patient's concurrent conditions, medical history or concomitant medication. On 25-AUG-2017 the patient was vaccinated with the first dose of PROQUAD for prophylaxis (dose and route of administration were not reported) lot number N004361 and expiration date of 07-AUG-2018. Then, on 22-SEP-2017, the patient received a second dose of PROQUAD for prophylaxis (dose, route of administration, lot number and expiration date were not reported). Subsequently, on 20-NOV-2017, the patient was administered a dose of VARIVAX lot # M042858 and expiration date of 21-OCT-2018, subcutaneous for prophylaxis. It was also reported an improperly stored vaccine administered (no details provided). No adverse effects were reported.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 20-DEC-2017, the patient was vaccinated with improperly stored dose of ZOSTAVAX lot number reported as N025701, expiration date reported as 16-DEC-2018 (dose, route and siute of administration were not reported) for prophylaxis. The sterile diluent (manufacturer unknown) was stored properly. The vaccine underwent a temperature excursion of 15 to 46 degrees Fahrenheit. No adverse event was reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1712USA014437:
Age: 47.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician assistant and refers to a 47 year old patient of unknown gender. There was no information regarding the patient's medical history, concomitant medications, drug reactions and allergies provided. On 06-DEC-2017, the patient was vaccinated with PROQUAD, therapy type rHA, lot # M044575, expiration date 04-MAY-2018, for prophylaxis (dose and route of administration were not provided). Concomitant therapies included sterile diluent. The administered dose of PROQUAD was stored in the refrigerator from 18-OCT-2017, in temperature of 38 degrees Fahrenheit for 1176 hours (49 days). The call was because of digital data logger. There was no previous temperature excursion. No adverse effect was reported. This is one of a several reports received from the same reporter. Sender's Comments: US-009507513-1712USA009167.