chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: F
Vaccine: FLUN4
Symptoms: Nasal congestion, Pyrexia, Respiratory tract congestion, Rhinorrhoea
Clinical narrative: A report has been received from a Health Professional concerning a 4 year old, female patient. Height 41.75 in; Weight 38.0 Pounds, who had been receiving nasal FLUMIST Quadrivalent, 0.2 milliliters, once/single administration. FLUMIST Quadrivalent started on an unknown date. The patient experienced had a fever on 02-DEC-2015, stuffy nose and runny nose, which started on 30-NOV-2015 and congestion which started during 2014. The outcome of the event of stuffy nose, runny nose, had a fever and congestion is unknown. The reporter's description of the event(s) was as follows: Patient was born one month prematurely. The report was considered to be non-serious by the company physician.
Sex: U
Vaccine: FLUN4
Symptoms: Incorrect product storage
Clinical narrative: A report has been received from a Health Professional concerning unknown number of patients with unknown gender, who received Nasal FLUMIST Quadrivalent, 0.2 milliliters. Once/Single administration. It was reported the patients may have received FLUMIST Quadrivalent during temperature excursion/one patient receive FLUMIST after a temperature excursion which started on 01-DEC-2015. The outcome of the event of patients may have received FLUMIST Quadrivalent during temperature excursion/one patient receive FLUMIST after a temperature excursion is unknown. The report was considered to be non-serious by the company physician.
Sex: U
Vaccine: FLUN4
Symptoms: Incorrect product storage
Clinical narrative: A report has been received from a Physician concerning a multiple patient of unknown genders, who had been receiving Nasal FLUMIST Quadrivalent started on 29-SEP-2015. The doctor reported that the FLUMIST Quadrivalent was administered to approximately 80 to 100 consumers during a temperature excursion with the vaccine between the dates of 29-SEP-2016 and 09-NOV-2015. The doctor was not able to provide the identifiable information pertaining to consumers involved in receiving the FLUMIST. The outcome of the event of administering to approximately 80 to 100  consumers during a temperature excursion with the vaccine was unknown. The report was considered to be non-serious.
Age: 0.9
Sex: M
Vaccine: FLUN4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: A report has been received from a Pharmacist concerning a nine month old, male patient, who received the Nasal FLUMIST Quadrivalent at a walk-in clinic. FLUMIST Quadrivalent was administered on 16-NOV-2015. Patient's primary care provider saw him after the administration and no adverse effect was noted. As per primary care provider's notes, patient was in a very good condition. The outcome of the event was unknown. The report was considered to be non-serious by the reporter.
Age: 43.0
Sex: F
Vaccine: FLUN3
Symptoms: Fatigue, Feeling cold, Pyrexia, Rhinorrhoea, Sneezing
Clinical narrative: A consumer report has been received. The report concerns a 43 year old Female consumer, who had been receiving Nasal FLUMIST. FLUMIST started on an unknown date. The patient experienced fever, feeling cold, sneezing, runny nose and tired. The patient recovered from the event of fever, feeling cold, sneezing, runny  nose and tired on an unspecified date. The report was considered to be non-serious by the company physician.
Age: 0.5
Sex: U
Vaccine: FLUN4
Symptoms: Drug administered to patient of inappropriate age, Upper respiratory tract infection
Clinical narrative: A report has been received from a Health Professional concerning a 6 month old, subject of unknown gender, who had been receiving Nasal FLUMIST Quadrivalent. FLUMIST Quadrivalent started on 30-OCT-2015. A six-month-old patient was administered 2 doses of FLUMIST Quadrivalent on OCT 30 and NOV 24, at their doctor's office. On November 13, the patient did return to the doctor's office for an upper respiratory tract infection. The outcome of the event of inadvertent administration to a 6-month-old is unknown and the patient recovered from the event of upper respiratory tract infection following FLUMIST administration on an unspecified date. The report was considered to be non-serious by the reporter. The reporter and company physician considered the events inadvertent administration to a 6-month-old and upper respiratory tract infection following FLUMIST administration to be unrelated to the suspect drug of FLUMIST Quadrivalent.
Age: 1.8
Sex: U
Vaccine: FLUN4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: A report has been received from a Health Professional concerning a subject of unknown gender, who had been receiving Nasal FLUMIST Quadrivalent. FLUMIST Quadrivalent started on an unknown date. A nurse from called Medical information to seek further information on administering FLUMIST to child under 2 years of age. She had received a call that a physician administered FLUNMIST to a 20 months old child. The child had no adverse events. The outcome of the event of FLUMIST Quadrivalent administered to a child under 2 years of age and FLUMIST to a child under 2 years of age is unknown. The reporter's description of the event(s) was as follows: child healthy otherwise. The report was considered to be non-serious by reporter and company physician. The reporter considered that there was no casual relationship between FLUMIST administered  to a chld under 2 years of age and FLUMIST Quadrivalent.
Age: 28.0
Sex: F
Vaccine: FLUN4
Symptoms: Exposure during pregnancy
Clinical narrative: A report has been received from a Physician concerning a 28 year old, female patient, who received Nasal FLUMIST, 0.2 milliliters. Once/Single administration. Inadvertent administrating during pregnancy and pregnant was given FLUMIST - Doctor was unable that it's a live virus were reported which started on 20-NOV-2015. The outcome of the events of inadvertent administration during pregnancy and pregnant was given FLUMIST - Doctor was unaware that it's a live virus is unknown. The event inadvertent administration during pregnancy was considered to be non-serious by the reporter and the event pregnant was given FLUMIST - doctor was unaware that it's a live virus was considered to be non-serious by the company physician.
Sex: U
Vaccine: FLUN4
Symptoms: Rhinorrhoea, Sneezing
Clinical narrative: A consumer report has been received. The report concerns a Male consumer, who had been received FLUMIST quadrivalent, (intranasal). FLUMIST quadrivalent, (intranasal) started on 19-Nov-2015. The patient experienced mild sneezing and mild runny nose. FLUMIST quadrivalent, (intranasal) was discontinued on 19-Nov-2015. The patient recovered from the event of sneezing and runny nose on 22-Nov-2015. The report was considered to be non-serious.
Sex: U
Vaccine: FLUN4
Symptoms: Incorrect product storage
Clinical narrative: A report has been received from a Health Professional concerning a patients of unknown gender, who had been receiving Nasal FLUMIST Quadrivalent. FLUMIST Quadrivalent started on an unknown date. It was reported that unknown number of patients had FLUMIST Quadrivalent during a temperature excursion while the FLUMIST was refrigerated. The outcome of the event of received the FLUMIST Quadrivalent during a temperature excursion while the FLUMIST was refrigerated is unknown. The report was considered to be non-serious.
Age: 16.0
Sex: F
Vaccine: FLUN4
Symptoms: Exposure during pregnancy
Clinical narrative: A spontaneous report has been received from a health professional, concerning a 16 years 34 weeks 5 days old female patient. Concomitant medications included doxylamine succinate, pyridoxine for nausea and ascorbic acid, biotin, minerals nos, nicotinic acid, retinol, tocopherol, vitamin b nos, vitamin d nos. Patient's medical history was not reported. It was reported that the patient was administered FLUMIST (intranasal) for unknown indication on 18-Nov-2014. At the time patient was not aware of being pregnant but after the administration she found out she was pregnant and it was considered wrongful administration to pregnant female. Patient did not experience any adverse events during or post administration. In subsequent follow up reporter stated that patient had normal delivery with healthy baby. Weight for newly born male baby was 3120 gm. The outcome of the events of vaccine exposure during pregnancy and wrongful administration to pregnant female were unknown. The outcome of the pregnancy was reported to be a healthy baby. The report was considered to be non-serious by reporter. The reporter considered there was no causal relationship between the wrongful administration to pregnant female and FLUMIST. Summary of follow-up information received by AstraZeneca/MedImmune on 10-Aug-2015 from health professional: Pregnancy outcome was added with end of pregnancy date. New concomitant medications were added. Patient's demography updated. Narrative was updated. Corrected Report 24-Aug-2015: Product type was updated. Reporter's causality was added. Case category was changed. Periodic report comment was added. Narrative was updated.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to a patient of unknown age. On 05-JAN-2016 the patient was vaccinated with a dose of improperly stored GARDASIL 9 (lot # L017407, exp date: 15-AUG-2017). The product was stored in temperature of 50.2 F degrees for 1 hour and 10 minutes. The temperature excursion was recorded by a data logger. There was no previous temperature excursion. No adverse effects reported. This is one of several reports received from same source. Additional information has been requested.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Activities of daily living impaired, Arthralgia, Erythema, Insomnia, Musculoskeletal pain
Clinical narrative: This spontaneous report as received from a pharmacist refers to an approximately 55 year old female patient. No medical history and concurrent conditions were reported. It was reported that the patient had no drug allergies or reactions. On 18-DEC-2015 the patient was vaccinated with ZOSTAVAX (lot # L032399, expiry date 26-NOV-2016) (dosing regimen and frequency unknown) subcutaneously in the right arm. Concomitant therapies included methylphenidate (manufacturer unknown), INVOKANA, fenofibrate (manufacturer unknown), simvastatin (manufacturer unknown), gabapentin (manufacturer unknown) and acyclovir (manufacturer unknown). On approximately 18-DEC-2015, after receipt of ZOSTAVAX the patient experienced a red spot on her arm which took a long time to disappear and also complained of left shoulder pain which radiates from the shoulder to the elbow causing difficulty in sleeping and the patient was unable to do any scrubbing (details unspecified). On approximately 17-DEC-2015 the patient had discontinued acyclovir (manufacturer unknown) 24 hours prior to the receipt of ZOSTAVAX (drug administration error). It was also reported that the patient did not resume therapy with acyclovir (manufacturer unknown) until 14 days after ZOSTAVAX. It was reported that the patient would be having an office visit with her physician on an unspecified date to discuss about the pain. There was no product quality complaint reported. The action taken with the therapy with ZOSTAVAX was unknown. The outcome of erythema, insomnia and musculoskeletal pain was reported as not recovered. The relatedness of the events to the therapy with ZOSTAVAX was unknown. This case is related to case number 1602USA009457 via same reporter link. Additional information has been requested.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This spontaneous report as received from a pharmacist refers to an approximately 55 year old female patient. No medical history and concurrent conditions were reported. It was reported that the patient had no drug allergies or reactions. On 18-DEC-2015 the patient was vaccinated with ZOSTAVAX (lot # L032399, expiry date 26-NOV-2016) (dosing regimen and frequency unknown) subcutaneously in the right arm. Concomitant therapies included methylphenidate (manufacturer unknown), INVOKANA, fenofibrate (manufacturer unknown), simvastatin (manufacturer unknown), gabapentin (manufacturer unknown) and acyclovir (manufacturer unknown). On approximately 18-DEC-2015, after receipt of ZOSTAVAX the patient experienced a red spot on her arm which took a long time to disappear and also complained of left shoulder pain which radiates from the shoulder to the elbow causing difficulty in sleeping and the patient was unable to do any scrubbing (details unspecified). On approximately 17-DEC-2015 the patient had discontinued acyclovir (manufacturer unknown) 24 hours prior to the receipt of ZOSTAVAX (drug administration error). It was also reported that the patient did not resume therapy with acyclovir (manufacturer unknown) until 14 days after ZOSTAVAX. It was reported that the patient would be having an office visit with her physician on an unspecified date to discuss about the pain. There was no product quality complaint reported. The action taken with the therapy with ZOSTAVAX was unknown. The outcome of erythema, insomnia and musculoskeletal pain was reported as not recovered. The relatedness of the events to the therapy with ZOSTAVAX was unknown. This case is related to case number 1602USA009457 via same reporter link. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: No adverse event, Product name confusion, Wrong drug administered
Clinical narrative: This spontaneous report was received from a consumer of unknown age and gender regarding himself/herself. Information regarding the patient's medical history and concurrent conditions were not provided. On an unknown date the patient was vaccinated with GARDASIL when she requested to be vaccinated with GARDASIL 9 (product name confusion). No adverse effects were reported. No product quality complaint (PQC) was involved. No laboratory tests were reported. The outcome of the events were unknown. No further information was provided. Additional information is not expected, no contact details were provided.
Sex: U
Vaccine: HPVX
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a health professional and refers to an adult patient. The patient's relevant medical history, concurrent condition and concomitant medication were not reported. The reporter read in an unspecified publication that on an unknown date, the patient, who was above 26 years of age was vaccinated with GARDASIL/GARDASIL 9 (it was unspecified if it was the GARDASIL or GARDASIL 9), intramuscularly (inappropriate schedule of drug administration). No adverse effect was reported. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Laboratory test
Clinical narrative: This spontaneous report as received from a clinical coordinator via a field employee refers to a 14 year old female patient. The patient's historical drugs included immunisation with 2 doses of GARDASIL on unspecified dates. She did not have any drug allergies. On an unknown date the patient was vaccinated with GARDASIL lot # K011562, dose 3. The patient was not on any concomitant medications. On an unknown date, 1 day following the immunisation, the patient experienced headache lasting until today (16-FEB-2016). It was reported that if the headache persists an Magnetic resonance imaging (MRI) will be done. Laboratory tests included CDC (results unspecified) on an unknown date. No product quality complaint (PQC) and insertion and removal related events (IRRE) was involved. The outcome of the event was reported as recovered/resolved on 16-Feb-2016. The causality assessment was not provided. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: Information has been received from a nurse practitioner referring to a patient of unknown age. Concurrent condition and medical history were not reported. It was reported that the patient was administered the first two doses of ENGERIX-B (dose, route and lot# not reported) on unspecified dates and then was administered the third dose in the series with RECOMBIVAX HB (dose, route and lot# not reported) on an unspecified date (Interchange of vaccine products). No adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to a patient of unknown age and gender. On 17-FEB-2016 the patient was vaccinated with an expired dose of ZOSTAVAX (lot # K20185, expiration date 27-JAN-2016) (dose and route were not reported). No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to an unspecified number of unspecified patients. On unspecified dates, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23, (single dose vials, Lot # L012042 with expiration date of 18-NOV-2016, dose and route were not reported), which were stored at 48 F for 36 hours (Incorrect product storage). The vaccines did not have previous temperature excursion. No adverse effects were reported. Additional information has been requested.
Age: 24.0
Sex: M
Vaccine: VARZOS
Symptoms: Drug administered to patient of inappropriate age, Injection site erythema
Clinical narrative: Information has been received from a physician referring to her son, a 24 year old male patient with no pertinent medical history or drug reactions/allergies. The patient received an initial dose of VARIVAX (Merck) at age of 5 years old (approximately in 1996). The reporter stated that she was under the impression that the patient was going to receive a second (booster) dose of VARIVAX (Merck) at age 24 years old when he visited his own physician on 16-FEB-2016, however, he was instead vaccinated with a dose of ZOSTAVAX (subcutaneous; lot# and expiration date were not reported at that visit. There was no concomitant medication. The reporter was uncertain whether the ZOSTAVAX was inadvertently administered instead of VARIVAX (Merck), or whether the patient's physician had decided to intentionally administer ZOSTAVAX to the patient for an unspecified reason. In February 2016, the patient developed redness at the injection site after receiving ZOSTAVAX. He consulted the reporter to seek medical attention and no treatment was given for the events. No lab diagnostic studies were performed. At the time of the report, the patient had not recovered from the event injection site erythema. Causality between injection site erythema and ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed vocational nurse and refers to three patients of unknown age and gender. The patients' medical history, concomitant therapy, drug reactions or allergies and concurrent conditions were not reported. The nurse reported one anonymous patient was vaccinated with improperly stored VARIVAX (Merck) (lot number L027287, expiration date 21-JUL-2017, dose, frequency and route were not reported) on an unspecified date and two anonymous patients were vaccinated with improperly stored VARIVAX (Merck) (lot number K026386, expiration date 15-DEC-2016, dose, frequency and route were not reported) on unspecified dates. The nurse reported that the doses were exposed to several "defrost cycles". No adverse symptoms reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to a patient of unknown age. On 05-JAN-2016 the patient was vaccinated with improperly stored GARDASIL 9 (lot # L017407, exp date: 15-AUG-2017). The product was stored in temperature of 50.2 F degrees for 1 hour and 10 minutes. The temperature excursion was recorded by a data logger. There was no previous temperature excursion. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Therapeutic response unexpected
Clinical narrative: Information has been received from an unspecified reporter via a website of the Internet referring to 3 patients with warts. On an unknown date the patients were vaccinated with unidentified Merck HPV vaccine (name and lot number not provided) (dose, dose# and route unknown). Some of the patient's warts disappeared after they received the HPV vaccine. Some experienced an improvement just two to three weeks after vaccination (therapeutic response unexpected). It was unspecified which patient's warts disappeared and which patient's warts improved. The outcome of the event was unknown. This is one of several reports received from the same source. Additional information has been requested.
Age: 41.0
Sex: F
Vaccine: HPV4
Symptoms: Therapeutic response unexpected
Clinical narrative: Information has been received from an unspecified reporter via a website of the internet referring to a 41 year old female patient with widespread warts. On an unknown date the patient was vaccinated with unidentified Merck HPV vaccine (name and lot number not provided) (dose, dose# and route unknown). The patient had not received treatment for her warts for 10 years, but many of her warts cleared about six months after she received the HPV vaccine (therapeutic response unexpected). The outcome of the event was unknown. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse concerning an unspecified patient of unknown age and gender. No concurrent condition, medical history and concomitant therapies were reported. On 26-JAN-2016, the patient received a dose of improperly stored oral, ROTATEQ (lot # L013197 with expire date 26-JAN-2017; dosage not reported). The temperature/time frame was Cumulative 34.1 F for 135 hours. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.08
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse concerning an unspecified patient of unknown age and gender. No concurrent condition, medical history and concomitant therapies were reported. On 26-JAN-2016, the patient received a dose of improperly stored RECOMBIVAX HB (lot # L044707 with expire date 06-OCT-2018; dose and route not reported). The temperature/time frame was Cumulative 34.1 F for 135 hours. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Discomfort, Pyrexia
Clinical narrative: PNEUMOVAX 23 given on 2-17-16 - cellulitis, subjective fever and discomfort.
Age: 46.0
Sex: M
Vaccine: TDAP
Symptoms: Erythema, Pain, Pyrexia, Skin warm, Swelling
Clinical narrative: Patient received ADACEL on 2-9-16. Red area, swollen, painful and warm to touch, low grade fever.
Age: 38.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Pain of skin, Skin warm, Swelling
Clinical narrative: PNEUMOVAX 23 on 2-17-16 - red, warm to touch, tender and minimal swelling.
Age: 86.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Injection site pruritus, Injection site rash, Injection site swelling, Swelling
Clinical narrative: Swelling, rash, itching at injection site 2/19 - 2/22. Swelling past elbow reported 2/24. Follow up with MD and diagnosis of cellulitis 2/22. Prescribed antibiotic and antihistamine. Follow up revealed improvement 2/23.
Age: 0.18
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV1
Symptoms: Back pain, Bowel movement irregularity, Flatulence, Irritability, Screaming
Clinical narrative: Within 24 hrs, fussy, gassy, aching back and only 2 bowel movements in 8 days after when normal 3 BM daily. Intermittent screaming around the clock. Already on ZANTAC for well controlled GERD. After 8 days back to normal.
Age: 47.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site bruising, Injection site erythema, Injection site pruritus, Injection site rash, Injection site warmth
Clinical narrative: On 2/3/16 after vaccination on 2/1/16 employee reports rash/blistered area at and around injection site, red, itching "a lot", slightly warm to touch. She is afebrile and says she feels fine. Recommended OC itch cream for cpox. Sent home to isolate from others until blisters are dried and scabbed. Symptoms all resolved 2-12-16.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash
Clinical narrative: Red, itchy, warm rash at injection site from shoulder to elbow.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a nurse and concerns of an unspecified patients of unknown age and gender. The patient's medical history and concurrent conditions were unknown. It was stated that on unspecified date, an improperly stored dose of VARIVAX (Merck) lot # L032391, expiry date 26-AUG-2017 (dose and route were not reported) and other lot number reported as L034268, expiry date 08-SEP-2017 (dose and route were not reported) were given to unspecified number of patients. It was reported that the vaccine was at 6 Fahrenheit of temperature and its time frame was 4 hours, there was not previous excursion. No adverse effects were reported. No product quality complaint (PQC) was involved. this is one of two reports from the same source. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV9, MENB
Symptoms: Back pain, Body temperature increased, Peripheral swelling, Skin warm
Clinical narrative: Pt began with temp 100.1-100.2 8 hours after HPV9 and TRUMENBA was administered. Pt also reports bad back pain. Left arm had swelling and was warm to touch.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Immediate post-injection reaction, Injection site mass, Musculoskeletal pain, Musculoskeletal stiffness, Myalgia
Clinical narrative: Immediate pain in shoulder and radiating down arm. Large lump at injection site. Shoulder frozen within two days of injection on side of body injection occurred. Shoulder is still frozen six months later. Muscles hardened and stiff and pain is 24/7.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Myosclerosis, Pain in extremity, Periarthritis
Clinical narrative: Immediate pain in shoulder and radiating down arm. Large lump at injection site. Shoulder frozen within two days of injection on side of body injection occurred. Shoulder is still frozen six months later. Muscles hardened and stiff and pain is 24/7.
Age: 0.18
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Diarrhoea, Emotional distress, Irritability, Screaming
Clinical narrative: Extreme fussiness, inconsolability. Parent states that fussy episodes happen several times daily, are random, and can last for several hours. Draws legs up, starts screaming. Not eating as much, poop seems waterier.
Age: 78.0
Sex: F
Vaccine: PNC13
Symptoms: Presyncope, Urticaria
Clinical narrative: Hives - over mon of bad - trunk, arms, legs, feet. Nearly fainting.
Age: 80.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Induration, Local reaction, Pain
Clinical narrative: Had local reaction to PREVNAR 13 consisting of pain, redness and induration that lasted 6 days. No systemic symptoms such as fever and chills.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse referring to a patient of unknown age and gender. No concurrent condition, medical history or concomitant therapy was provided. On 28-JAN-2016, the patient was vaccinated with improperly stored VARIVAX (Merck) (lot # L025209 and expiration date: 07-JUL-2017, dose and route not reported), after a reported temperature excursion of 13.7 Fahrenheit (F) for 1 hour and 51 minutes. The previous temperature excursion was reported as 13.5 F for 57 hours and 27 minutes, 14.8 F for 20 hours and 33 minutes, and cumulative excursion was reported as 13.7 F for 61 hours and 3 minutes, 14.8 F for 20 hours and 33 minutes. The temperature had been back in range. No adverse effects were reported. All telephone attempts to obtain follow up information had been unsuccessful. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse referring to a patient of unknown age and gender. No concurrent condition, medical history or concomitant therapy was provided. On 29-JAN-2016, the patient were vaccinated with an improperly stored dose of VARIVAX (Merck) (lot # L025209 and expiration date 07-JUL-2017, dose and route not reported), which was stored under 10.1 F for 1 hour and 57 minutes. The previous temperature excursion was reported as 13.7 F for 61 hours and 38 minutes, 14.8 F for 20 hours and 33 minutes, and Cumulative excursion was reported as 13.7 F for 63 hours and 35 minutes, 14.8 F for 20 hours and 33 minutes. No adverse effects were reported. All telephone attempts to obtain follow up information had been unsuccessful. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse referring to a patient of unknown age and gender. No concurrent condition, medical history or concomitant therapy was provided. On 04-FEB-2016, the patient were vaccinated with improperly stored VARIVAX (Merck) (lot # L025209 and expiration date: 07-JUL-2017, dose and route not reported). No adverse effects were reported. All telephone attempts to obtain follow up information had been unsuccessful. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 1.22
Sex: M
Vaccine: VARCEL
Symptoms: Unevaluable event
Clinical narrative: Information has been received from a licensed practical nurse referring to a 1 year old male patient. No concurrent condition, medical history or concomitant therapy was provided. On 13-JAN-2016 at 15:46, the patient was subcutaneously vaccinated in the right thigh with the first dose of VARIVAX (Merck) (lot # L0252047, expiration date on 07-JUL-2017, dose unknown). No adverse effects were reported. All telephone attempts to obtain follow up information had been unsuccessful. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 1.1
Sex: F
Vaccine: MMR, MNQ, PNC13, VARCEL
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None.
Age: 1.13
Sex: F
Vaccine: VARCEL
Symptoms: Unevaluable event
Clinical narrative: Information has been received from a licensed practical nurse referring to a 1 year old female patient. No concurrent condition, medical history or concomitant therapy was provided. On 12-JAN-2016 at 10:16, the patient was subcutaneously vaccinated in the right thigh with the first dose of VARIVAX (Merck) (lot # L025207, expiration date on 07-JUL-2017, dose unknown). No adverse effects were reported. All telephone attempts to obtain follow up information had been unsuccessful. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.61
Sex: M
Vaccine: HIBV
Symptoms: Pharyngitis, Pyrexia, Swelling face
Clinical narrative: Mom reported fever of 104.7 and face swelling. Parent reported taking child to the ER. Stated ER dr dx with pharyngitis gave rx for antibiotic. Parent stated took child to family dr the same day. Dr. told her it was a reaction to the vaccine. Stated child also had rx to the antibiotic. Mother stated she alternated MOTRIN/TYLENOL per MD order to tx fever that day.
Age: 0.13
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site swelling
Clinical narrative: Rt leg localized redness/swelling immed. after PENTACEL and Hep B administration. Applied cold pack to area. TYLENOL admin for comfort.
Sex: F
Vaccine: HPV4
Symptoms: Premature menopause
Clinical narrative: This spontaneous report was received from an unspecified reporter through an unknown reporter via social media and refers to an unspecified female patients reported as "girls" of unknown age. The patients' concurrent conditions and medical history were not provided. On an unknown date, the patients were vaccinated with a dose of GARDASIL (dose, route of administration, lot number and expiration date were not reported). There were no concomitant medications reported. The reporter stated that GARDASIL cause premature menopause in girls (dates not provided). The outcome of premature menopause was not provided. The reporter considered premature menopause to be related to GARDASIL. Additional information is not expected because the reporter contact details were not provided.
Age: 17.0
Sex: F
Vaccine: HEPA, HPV4, MNQ
Symptoms: Dizziness, Pallor
Clinical narrative: Patient pale and she said she was going to pass out. Did not pass, but was very pale.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. Concurrent conditions and medical history was not reported. The healthcare worker reported that, on 19-FEB-2016, the patient was vaccinated with improperly stored GARDASIL 9 vaccine), lot # K011325 with expiration date 17-APR-2017, (dose number, dosage and route unspecified). The vaccine was exposed to the temperature of 15.3 degrees C for 240 hours. The vaccine had not undergone previous temperature excursion. No adverse symptoms were reported. No further information was provided. Product quality complaint was not involved. Additional information has been requested.
Age: 30.0
Sex: M
Vaccine: MNQ
Symptoms: Asthenia, Headache, Influenza like illness, Pyrexia
Clinical narrative: Pt complained of fever (unable to take at hm. for accurate temp reading), weakness in body, headache, described S/S as "Flu-like" per pt. started at 3AM 2-23-16, pt got vaccine for travel at end of yr. Was advised to take TYLENOL for fever.
Age: 0.1
Sex: U
Vaccine: HEP, RV5
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to a 5 week old patient (unspecified gender). The patient's medical history and concurrent conditions were not reported. On an unknown date, the 5 weeks old patient was vaccinated with RECOMBIVAX HB (lot # L044694, expiration date 04-FEB-2018) (route, dose number information, dose, frequency and concentration were not provided) and with ROTATEQ orally, (lot # L035508, expiration date 12-MAY-2017) (dose number information, dose, frequency and concentration were not provided). Concomitant medications were not reported. No Adverse effects were reported. There was no product quality complaint (PQC) reported. Additional information has been requested.
Age: 0.3
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to a 4 month old patient of unknown gender. Concurrent conditions or pertinent medical history were not reported. On 18-FEB-2016, the patient was inadvertently vaccinated with an expired dose of oral, ROTATEQ (lot # K004795, expiration date: 11-FEB-2016) (dose and frequency were unspecified). Concomitant medications were not reported. No adverse events were reported. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a health care worker referring to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions and medical histories were not provided. On an unspecified dates: in September 2015, and in December 2015, the patients were vaccinated with unspecified doses of improperly stored of GARDASIL 9, lot # L014415, expiration date 25-JUL-2017, lot # L016428, expiration date 30-JUL-2017 and lot # L016429, expiration date 09-AUG-2017, respectively, (routes, doses and anatomical sites of vaccination were not provided). It was reported that the temperature of excursion were the following: 53.6 for 392 hours, 58.5 F for 465 hours and 46.2 F for 15 hours, respectively. The outcome of excursion was not supported. Co-suspect therapies or concomitant medications were not provided. No adverse effects were reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 38.0
Sex: F
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse referring to a 38 year old female patient. The patient's concurrent conditions and medical history were not provided. On 17-FEB-2016, the patient was vaccinated with an expired dose of M-M-R II lot number reported as: J01623, expiration date on 19-DEC-2015 (route, anatomical location, and dose were not provided). There was no concomitant medication described. No adverse effects were reported. No product quality complaint was involved. J01623 is an invalid lot number for M-M-R II. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse regarding a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On 22-FEB-2016, the patient was vaccinated with an expired dose of ZOSTAVAX (dose and route were not reported, lot # K021953, expiration date 10-FEB-2016). There was no adverse event reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to an unspecified number of patients of unknown age and gender. No information on patients' medical history, concurrent conditions or concomitant medications was provided. On an unknown date in 2016, the patients were vaccinated with the improperly stored dose of PROQUAD (Merck) (lot # L024123, expiration date 30-DEC-2016; dose and route were not provided). No adverse effects were reported. The vaccines were exposed to 17.2 Fahrenheit (F) for 2 hours on 12-JAN-2016 and to 8.1 F for 12 hours on an unknown date in 2016. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 1.17
Sex: M
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. No information on patient's medical history, concurrent conditions or concomitant medications was provided. On an unknown date in 2016, the patient was vaccinated with the improperly stored dose of VARIVAX (Merck) (lot # L034368, expiration date 08-SEP-2017; dose and route were not provided). No adverse effects were reported. The vaccine was exposed to 17.2 Fahrenheit (F) for 2 hours on 12-JAN-2016 and to 8.1 F for 12 hours on an unknown date in 2016. This is one of several reports received form the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a nurse and concerns of an unspecified patients of unknown age and gender. The patient's medical history and concurrent conditions were unknown. It was stated that on unspecified date, an improperly stored dose of PROQUAD (Merck) lot # L034932, expiry date 03-MAR-2017, (dose and route were not reported) were given to the unspecified number of patients. It was reported that the vaccine was at 6 Fahrenheit of temperature and its time frame was 4 hours, there was not previous excursion. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of two reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse concerning of multiple unspecified patients of unknown age and gender. On an unknown date the patients received improperly stored doses of PROQUAD (Merck) (lot # L032761 with expire date 24-FEB-2017, dosage and route not reported). The condition storage was 7 F for 10 minutes. There was previous temperature excursion with 8F for 40 minutes and 18.2 F for 5 minutes. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to a patient of unknown age. On 05-JAN-2016 the patient was vaccinated with a dose of improperly stored oral, ROTATEQ (lot # L022447, exp date: 26-JUN-2017). The product was stored in temperature of 50.2 F degrees for 1 hour 10 minutes. The temperature excursion was recorded by a data logger. There was no previous temperature excursion. No adverse effects reported. This is one of several reports received from same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to a patient of unknown age. On 05-JAN-2016 the patient was vaccinated with a dose of improperly stored ROTATEQ (Lot # L022447, exp date: 26-JUN-2017) oral. The product was stored in temperature of 50.2 F degrees for 1 hour 10 minutes. The temperature excursion was recorded by a data logger. There was no previous temperature excursion. No adverse effects reported. This is one of several reports received from same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to a patient of unknown age. On 05-JAN-2016 the patient was vaccinated with a dose of improperly stored oral, ROTATEQ (Lot # L022447, exp date: 26-JUN-2017). The product was stored in temperature of 50.2 F degrees for 1 hour and 10 minutes. The temperature excursion was recorded by a data logger. There was no previous temperature excursion. No adverse effects reported. This is one of several reports received from same source. Additional information has been requested.
Age: 35.0
Sex: F
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a certified medical assistant referring to a patient of unknown age and gender. On 19-FEB-2016 the patient was administered an expired dose of the M-M-R II (lot # K000255, expiration date: 08-JAN-2016, subcutaneous, dose was unknown) (expired product administered). The patient had no known adverse effect at the reporting time. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered, Injection site erythema, Injection site pain
Clinical narrative: Information has been received from a healthcare worker referring to a 68 year old female patient. The patient's medical history and concurrent conditions were not provided. On an unknown date in November 2014, the patient was vaccinated with initial dose of ZOSTAVAX (lot# K003596, expiration date unspecified, dose, route not provided). On 12-FEB-2016, she inadvertently administered a second dose of ZOSTAVAX (lot # L029485, expiration date 06-NOV-2016, dose and route not provided). Concomitant therapies were not provided. Patient developed redness and soreness at the injection site in her right arm an unspecified amount of time after the second dose of ZOSTAVAX. The patient visited physician for seeking medical attention and there were no diagnostics studies lab performed. The outcome of events was unknown. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to a patient of unknown age. On 05-JAN-2016 the patient was vaccinated with a dose of improperly stored VAQTA (lot # L039659, exp date: 15-MAR-2017). The product was stored in temperature of 50.2 F degrees for 1 hour 10 minutes. The temperature excursion was recorded by a data logger. There was no previous temperature excursion. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to a patient of unknown age. On 05-JAN-2016 the patient was vaccinated with a dose of improperly stored VAQTA (lot # L039659, exp date: 15-MAR-2017). The product was stored in temperature of 50.2 F degrees for 1 hour 10 minutes. The temperature excursion was recorded by a data logger. There was no previous temperature excursion. No adverse effects reported. This is one of several reports received from same source. Additional information has been requested.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not provided. On 19-FEB-2016, the patient was inadvertently administered a dose of PROQUAD (Merck) (lot number # L030592, expiration date 12-FEB-2017, dose and route not provided) and a dose of VARIVAX (Merck) (dose, lot number and route not provided) (overdose). Concomitant therapies were not provided. No adverse effects were reported. There was no product quality issue (PQC) involved. Additional information has been requested.
Age: 35.0
Sex: M
Vaccine: MMR
Symptoms: Expired product administered, Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and gender. The patient's concurrent and historical conditions were not reported. On 16-FEB-2016 the patient was vaccinated with a properly stored, expired dose of M-M-R II (lot # K002036, expiration date 10-FEB-2016, dose and route were unknown). Concomitant therapies were not reported. No adverse events were reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event, Underdose
Clinical narrative: Information has been received from a registered nurse referring to an adult patient of unknown gender. On 19-FEB-2016, the patient was mistakenly administered a pediatric dose of VAQTA (lot # L015460, expiration date 20-JUL-2017, dose, route not provided) (inappropriate schedule of vaccine administered and underdose). No adverse effects were reported. There was no product quality issue (PQC) involved. Additional information has been requested.