chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
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. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On an unknown date, the patients were vaccinated with improperly stored doses of PROQUAD lot # L050908, expiration date reported as 14-JUN-2017 (dose and route of administration were not reported). There was no adverse effect reported. Administered does of vaccine experienced the temperature excursion of -4.8 degrees Celsius for 3 hours 4 minutes. There was previous excursion of 1.1 degrees Celsius for 7 hours 14 minutes. Data logger was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: MMR
Symptoms: Rubella antibody negative
Clinical narrative: This spontaneous report as received from a nurse refers to a 25 year old male patient. The patient's concurrent conditions and medical history were unspecified by the reporter. The patient did not have any known drug reactions/allergies. On 09-OCT-1995, the patient was vaccinated with M-M-R II (strength, lot#, therapy type, dose number and route unspecified). On18-MAY-2016, the patient had blood titer drawn, and he was found to be negative for rubella antibodies. The patient's present status was unspecified (outcome unspecified). Product quality complaint (PQC) was not involved. Causality assessment was not provided by the reporter. No further information was provided. Additional information has been requested.
Sex: U
Vaccine: VARCEL
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. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On an unknown date, the patients were vaccinated with improperly stored doses of VARIVAX lot # M000756, expiration date reported as 16-JAN-2018, lot # L043622, expiration date reported as 03-NOV-2017 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccine experienced the temperature excursion of -4.8 degrees Celsius for 3 hours 4 minutes. There was previous of 1.1 degrees Celsius for 7 hours 14 minutes for doses with lot # L043622. Data logger was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
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. There was no information about the patient's concurrent conditions, concomitant therapies or medical histories provided. On an unknown date, the patients were vaccinated with improperly stored doses of ROTATEQ lot # L029617, expiration date reported as 17-MAY-2017, lot # L028645, expiration date reported as 25-MAY-2107 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccine experienced the temperature excursion of 13.9 degrees Celsius for 3 hours and 20 minutes. There was previous excursion of 14.2 degrees Celsius for 5 hours. Data logger was involved. This in one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
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. There was no information about the patient's concurrent conditions, concomitant therapies or medical histories provided. On an unknown date, the patient was vaccinated with an improperly stored dose of M-M-R II lot # L027431, expiration date reported as 22-JUL-2017 (therapy type, dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 13.9 degrees Celsius for 3 hours 20 minutes. There was previous excursion of 14.2 degrees Celsius for 5 hours. Data logger was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified patients of unspecified age and gender. The patients' concurrent conditions and medical history were unspecified. On an unspecified dates, the patients were vaccinated with improperly stored doses of VAQTA (strength route and anatomical location unspecified) with lot # L026600 and expiration date 15-MAR-2017. Number of doses administered was unspecified. The vaccine was exposed to temperature of 33.6F, for time of 2 hours 30 minutes. No previous temperature excursion was reported. The temperature excursion was detected by a data logger. No adverse effects were reported. No product quality complaint (PQC) was involved. No additional information was provided. This is one of three reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified patients of unspecified age and gender. The patients' concurrent conditions and medical history were unspecified. On an unspecified dates, the patients were vaccinated with improperly stored doses of ROTATEQ (strength and anatomical location unspecified) with lot # L027726 and expiration date 10-MAY-2017; with lot# L033694 and expiration date 16-JUN-2017; viral oral route. Number of doses administered was unspecified. The vaccine was exposed to temperature of 33.6F, for time frame of 2 hours 30 minutes. No previous temperature excursion was reported. The temperature excursion was detected by a data logger. No adverse effects were reported. No product quality complaint (PQC) was involved. No additional information was provided. This is one of three reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 16-JUN-2011, the patient received the first dose of GARDASIL (lot number, dose, anatomical site of injection and route were not reported). On 31-MAY-2016, the patient received the second dose of GARDASIL 9. (lot number, dose, anatomical site of injection and route were not reported). No adverse effects were reported. No product quality complain (PQC) was involved. Additional information has been requested.
Age: 17.0
Sex: M
Vaccine: HPV9, MENB, MNQ, HPVX, MEN, MENB
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Patient received Men B vaccine in RA and HPV4 and MCV4 in LA on 6/6/16. On 6/7/16 he called the doctor complaining of severe pain in RA and not being able to lift the arm. The pain continued on 6/8/16 when the doctor saw him for a well check. She advised him to take ibuprofen.
Age: 17.0
Sex: M
Vaccine: HPV9, MENB, MNQ, HPVX, MEN, MENB
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Patient received Men B vaccine in RA and HPV4 and MCV4 in LA on 6/6/16. On 6/7/16 he called the doctor complaining of severe pain in RA and not being able to lift the arm. The pain continued on 6/8/16 when the doctor saw him for a well check. She advised him to take ibuprofen.
Age: 1.16
Sex: F
Vaccine: HEPA, HIBV, MMR, VARCEL
Symptoms: Injection site rash
Clinical narrative: 06/09/2016 Mild rash to both upper extremities and required evaluation at local ER. Instructed to administer oral Benadryl with cold/warm compresses to sites. Received varicella to L arm and MMR to R arm.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Local swelling, Skin discolouration, Skin warm, Vaccination site swelling
Clinical narrative: Right arm has pink raised area on inner portion-above antecubital space between elbow and axillary area-approximately 2 inches X 4 inches, no fever but area is warm to touch. Vaccine site slightly raised- no redness at site.
Age: 14.0
Sex: M
Vaccine: HEPA, HPV9, MNQ
Symptoms: Injection site swelling
Clinical narrative: Soft tissue swelling to (R) upper arm.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Abdominal X-ray, Amylase, Crying, Full blood count, Irritability
Clinical narrative: 6/8/16 - presented with fussiness, irritable, inconsolable crying. Evaluated in office and ED. Work-up for intussusception negative. D/C home and did better. 6/13/16 - vomiting and inconsolable crying - evaluated in office. Started omeprazole - very large stool noted - doing better.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Lipase, Occult blood, Vomiting
Clinical narrative: 6/8/16 - presented with fussiness, irritable, inconsolable crying. Evaluated in office and ED. Work-up for intussusception negative. D/C home and did better. 6/13/16 - vomiting and inconsolable crying - evaluated in office. Started omeprazole - very large stool noted - doing better.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Patient came to pharmacy with red quarter size spot at ZOSTAVAX administration site. No itching, no heat, no streaking. Called doctor's office and they said tell pt to watch it. When called the patient the red spot had gotten larger and advised her to call Dr. She saw Dr. they told her ice and BENADRYL.
Age: 35.0
Sex: F
Vaccine: HEP, VARCEL
Symptoms: Cellulitis, Induration, Pruritus
Clinical narrative: Pruritus, induration, cellulitis. Antibiotics started 6/17/16.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse events. However, vaccine was administered twice to patient. First 11/23/15 and 2nd 2/4/16.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified patients of unspecified age and gender. The patients' concurrent conditions and medical history were unspecified. On an unspecified dates, the patients were vaccinated with improperly stored dose of RECOMBIVAX HB (strength, route and anatomical location unspecified) with lot # M003658 and expiration date 02-JUN-2018. Number of doses administered was unspecified. The vaccine was exposed to temperature of 33.6F, for a time frame of 2 hours 30 minutes. No previous temperature excursion was reported. The temperature excursion was detected by a data logger. No adverse effects were reported. No product quality complaint (PQC) was involved. No additional information was provided. This is one of three reports received from the same reporter. Additional information has been requested.
Age: 27.0
Sex: F
Vaccine: RAB
Symptoms: Nausea, Pain in extremity
Clinical narrative: Very sore arm, nausea.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Abdominal pain, Arthralgia, Blood test, Computerised tomogram abdomen, Hypothyroidism
Clinical narrative: Occipital Neuralgia, irregular menses, abdominal pain, chronic pain including joints and muscles, low thyroid. Patient was hospitalized on 6/1/15 after 3rd vaccination.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Menstruation irregular, Myalgia, Nuclear magnetic resonance imaging brain, Occipital neuralgia, Pain
Clinical narrative: Occipital Neuralgia, irregular menses, abdominal pain, chronic pain including joints and muscles, low thyroid. Patient was hospitalized on 6/1/15 after 3rd vaccination.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Ultrasound abdomen
Clinical narrative: Occipital Neuralgia, irregular menses, abdominal pain, chronic pain including joints and muscles, low thyroid. Patient was hospitalized on 6/1/15 after 3rd vaccination.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Eye pain, Photophobia
Clinical narrative: Eyeballs hurt when she moved them. (Eye muscles were sore). Eyes also very sensitive to light. Had to wear sunglasses . Indoor and outdoor lighting was very bright compared to normal and hurt the eyes.
Age: 59.0
Sex: F
Vaccine: DTAP
Symptoms: Abdominal pain upper, Cold sweat, Headache, Hyperhidrosis, Injection site pain
Clinical narrative: Extreme stomachs pain, headache and nausea. Very sore arm at injection site. At 8:00 AM I started throwing up and getting sweaty and clammy.  I took a Zofran and laid down with saltine crackers...  The symptoms are ongoing at this time.
Age: 59.0
Sex: F
Vaccine: DTAP
Symptoms: Vomiting
Clinical narrative: Extreme stomachs pain, headache and nausea. Very sore arm at injection site. At 8:00 AM I started throwing up and getting sweaty and clammy.  I took a Zofran and laid down with saltine crackers...  The symptoms are ongoing at this time.
Age: 56.0
Sex: M
Vaccine: TDAP
Symptoms: Fatigue, Headache, Injection site pain, Myalgia
Clinical narrative: Low grade headache. General muscle aches in entire body. Tiredness. Pain where shot was given.
Age: 75.0
Sex: F
Vaccine: FLU3, FLUX, UNK
Symptoms: Arthralgia, Burning sensation, Drug administered at inappropriate site, Immediate post-injection reaction, Mobility decreased
Clinical narrative: 2 seconds after vaccine felt like boiling water had been poured on shoulder.  Vaccine was given up on top of shoulder bones. Aching followed immediately.  Next two days could not lift arm.  Since that time have had aching in shoulder, arm muscles wrist, thumb hips joints ankle and joints in feet.  Never had these before.
Age: 75.0
Sex: F
Vaccine: FLU3, FLUX, UNK
Symptoms: Myalgia, Pain in extremity
Clinical narrative: 2 seconds after vaccine felt like boiling water had been poured on shoulder.  Vaccine was given up on top of shoulder bones. Aching followed immediately.  Next two days could not lift arm.  Since that time have had aching in shoulder, arm muscles wrist, thumb hips joints ankle and joints in feet.  Never had these before.
Age: 75.0
Sex: F
Vaccine: FLU3, FLUX, UNK
Symptoms: Arthralgia, Fine motor skill dysfunction, Pain, Pain in extremity
Clinical narrative: 2 seconds after vaccine felt like boiling water had been poured on shoulder.  Vaccine was given up on top of shoulder bones. Aching followed immediately.  Next two days could not lift arm.  Since that time have had aching in shoulder, arm muscles wrist, thumb hips joints ankle and joints in feet.  Never had these before.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Dizziness, Syncope
Clinical narrative: Lightheaded and fainted onto the floor.
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Fatigue, Pyrexia
Clinical narrative: Fever of 102, feeling very tired.  Fever continues next day of 101, symptoms ongoing as of time of this report. Weekend so can not speak to clinic.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Pruritus generalised
Clinical narrative: The patient has a 3 inch diameter red swelled area on her right arm where the injection was given and states that she feels itchy all over her body, no other redness or rash is present other than her arm.
Age: 14.0
Sex: F
Vaccine: TD
Symptoms: Dizziness, Headache, Pyrexia
Clinical narrative: Headache, dizziness, fever 102.5.
Age: 23.0
Sex: M
Vaccine: ANTH
Symptoms: Cardiac function test normal, Chills, Dehydration, Drug screen negative, Dysphonia
Clinical narrative: 23 year old male that presented to the clinic at around 2AM on 17 Jun 2016 with hypotension, weakness in his legs, flushing, voice changes, fullness feeling to his throat, overall fatigue, shakiness, burning sensation over his eyes that is relieved with pressure and chills that started around 2100 after an arm and ab workout.  Pt felt like he might be dehydrated so he tried to drink several bottles of water. Pt was given 2L of NS, 125mg solumedrol IV, 12.5mg Benadryl IV, 150mg Zantac po and was then admitted to the ICU for monitoring. A cbc, cmp, cardiac panel, UA, drug screen did not have any significant results. Pt improved over the course of 5-6 hours and after 24-30 hours in the hospital and repeat labs that were again negative the patient was discharged home. Pt was instructed to not get the anthrax vaccine in the future and to follow up in 1 week.
Age: 23.0
Sex: M
Vaccine: ANTH
Symptoms: Eye irritation, Fatigue, Flushing, Full blood count normal, Hypotension
Clinical narrative: 23 year old male that presented to the clinic at around 2AM on 17 Jun 2016 with hypotension, weakness in his legs, flushing, voice changes, fullness feeling to his throat, overall fatigue, shakiness, burning sensation over his eyes that is relieved with pressure and chills that started around 2100 after an arm and ab workout.  Pt felt like he might be dehydrated so he tried to drink several bottles of water. Pt was given 2L of NS, 125mg solumedrol IV, 12.5mg Benadryl IV, 150mg Zantac po and was then admitted to the ICU for monitoring. A cbc, cmp, cardiac panel, UA, drug screen did not have any significant results. Pt improved over the course of 5-6 hours and after 24-30 hours in the hospital and repeat labs that were again negative the patient was discharged home. Pt was instructed to not get the anthrax vaccine in the future and to follow up in 1 week.
Age: 23.0
Sex: M
Vaccine: ANTH
Symptoms: Intensive care, Metabolic function test normal, Muscular weakness, Sensation of foreign body, Throat tightness
Clinical narrative: 23 year old male that presented to the clinic at around 2AM on 17 Jun 2016 with hypotension, weakness in his legs, flushing, voice changes, fullness feeling to his throat, overall fatigue, shakiness, burning sensation over his eyes that is relieved with pressure and chills that started around 2100 after an arm and ab workout.  Pt felt like he might be dehydrated so he tried to drink several bottles of water. Pt was given 2L of NS, 125mg solumedrol IV, 12.5mg Benadryl IV, 150mg Zantac po and was then admitted to the ICU for monitoring. A cbc, cmp, cardiac panel, UA, drug screen did not have any significant results. Pt improved over the course of 5-6 hours and after 24-30 hours in the hospital and repeat labs that were again negative the patient was discharged home. Pt was instructed to not get the anthrax vaccine in the future and to follow up in 1 week.
Age: 23.0
Sex: M
Vaccine: ANTH
Symptoms: Tremor, Urine analysis normal
Clinical narrative: 23 year old male that presented to the clinic at around 2AM on 17 Jun 2016 with hypotension, weakness in his legs, flushing, voice changes, fullness feeling to his throat, overall fatigue, shakiness, burning sensation over his eyes that is relieved with pressure and chills that started around 2100 after an arm and ab workout.  Pt felt like he might be dehydrated so he tried to drink several bottles of water. Pt was given 2L of NS, 125mg solumedrol IV, 12.5mg Benadryl IV, 150mg Zantac po and was then admitted to the ICU for monitoring. A cbc, cmp, cardiac panel, UA, drug screen did not have any significant results. Pt improved over the course of 5-6 hours and after 24-30 hours in the hospital and repeat labs that were again negative the patient was discharged home. Pt was instructed to not get the anthrax vaccine in the future and to follow up in 1 week.
Age: 1.25
Sex: M
Vaccine: HIBV, MNQ
Symptoms: Erythema, Injection site pain, Irritability, Pyrexia, Rash
Clinical narrative: Rash fever 102.6, and fussy, pain in injection site, redness increased on one side.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Pain, Pain in extremity, Peripheral swelling
Clinical narrative: Severe and debilitating sinus infection accompanied by fever, chills, and headache. Symptoms may have been exacerbated due to allergic reaction to neomycin. After-effects and pain and swelling in arm continue as do the symptoms of sinusitis. Consultation with doctor over concern about allergic reaction.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Sinusitis, Swelling
Clinical narrative: Severe and debilitating sinus infection accompanied by fever, chills, and headache. Symptoms may have been exacerbated due to allergic reaction to neomycin. After-effects and pain and swelling in arm continue as do the symptoms of sinusitis. Consultation with doctor over concern about allergic reaction.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site bruising, Nodule, Pain, Pruritus
Clinical narrative: Red knots that hurts and is itchy. Feels like I am being pinched. the actual site of injection is bruised, but the red knots are just under it.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On an unknown date, the patient was inadvertently vaccinated with an expired dose of RECOMBIVAX HB (strength, dose number, anatomical location and route were not provided) lot # K014697, expired date on 04-FEB-2016. Concomitant therapies were not provided. No adverse event was reports. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age. It was reported that the patient received 3 doses of GARDASIL 9 on a schedule that differed from the recommended dosage schedule. The dates of the patient's three doses were as follows: 03-MAR-2016, 10-MAY-2016, and 14-JUN-2016. No adverse effects were reported. No product quality complaint (PQC) was reported for GARDASIL 9. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to multiple unspecified patients of unknown age and gender. No information regarding the patients' medical history, and concurrent condition was provided. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB, injection, lot # L018500, expiration date 13-APR-2017; lot # L033343, expiration date 16-JUN-2017, (dose, route of administration and concentration were not reported). Concomitant medications were not reported. No adverse effects were reported and no product quality complaint (PQC) was involved. This is one of two cases from the same reporter. 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 medical assistant referring to multiple unspecified patients of unknown age and gender. No information regarding the patients' medical history, and concurrent condition was provided. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ, oral liquid, lot # L033693, expiration date 31-MAY-2017; lot # L033343, expiration date 16-JUN-2017, orally, (dose and concentration were not reported). Concomitant medications were not provided. No adverse effects were reported and no product quality complaint (PQC) was involved. This is one of two cases from the same reporter. 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 Registered Medical Assistant (R.M.A) concerning a multiple unspecified patients of unknown age and gender. The patients' pertinent medical history and concurrent conditions were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of VARIVAX (Lot # L048465: expiration date 02-DEC-2017; Lot # L037565: expiration date 29-SEP-2017) (routes and doses were not provided). No adverse effects reported. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This spontaneous prospective pregnancy report as received from a health care worker refers to a female patient of unknown age. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with GARDASIL 9 (lot # L043212, expiry date: 28-AUG-2017) (route of administration: intramuscular). On an unknown date, the patient inadvertently received a dose of GARDASIL 9 while she was pregnant (inadvertent exposure to vaccine), (vaccine exposure during pregnancy). No adverse effects reported. The outcome of the events was not reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patient received GARDASIL for her first dose and GARDASIL 9 as a second dose. No adverse symptoms reported. The outcome of the events was unknown. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. Pertinent medical history and drug reactions/allergies were not reported. In July 2012, the patient was vaccinated with a dose of ZOSTAVAX, subcutaneously (lot number, expiration date and dose were not reported). Concomitant medications were not reported. Subsequently, on 09-JUN-2016, the patient was inadvertently administered a second dose of ZOSTAVAX, subcutaneously, batch, lot number reported as L040443, expiration date: 15-JAN-2017, (dose was not reported). No adverse effects were reported. No product quality complain (PQC) was involved. No further details were provided. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a adult patient of unknown age and gender. On 19-MAY-2106, the patient was inadvertently vaccinated with one pediatric dose of RECOMBIVAX HB (lot # M001578 and expiry date: 21-NOV-2018). No adverse effect reported. No product quality complaint (PQC) was reported for RECOMBIVAX HB. 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 Pharmacist, referring to unspecified number of patients of unknown age and gender. No pertinent medical history, drug reactions/ allergies or concurrent conditions were reported. On an unknown date, the patients were vaccinated with 12 doses of improperly stored VARIVAX (which had a lot # L037561 and an expiration date of 29-SEP-2017; however, dosage number and route of administration were not reported). Nonetheless, no adverse effects were reported. Another batch of VARIVAX (which had a lot # L013066 and an expiration date of 14-APR-2017) had also been improperly stored and had been administered. The vaccines experienced the following temperature excursions on the following dates: 21 F for 5 hours. Reportedly, there had been no previous temperature excursions and the aforementioned ones were identified due to a data logger. Furthermore, no product quality complaint was involved. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Pharmacist, referring to unspecified number of patients of unknown age and gender. No pertinent medical history, drug reactions/allergies or concurrent conditions were reported. On an unknown date, the patients were vaccinated with 9 dose of improperly stored PROQUAD (which had a lot # of L016393 and an expiration date of 08-NOV-2017; however, dosage number and route of administration were not reported. Nonetheless, no adverse effects were reported. Another batch of VARIVAX (which had a lot # of L045678 and an expiration date of 09-MAY-2017; and a report lot # as M002056 with expiration date on 11-JUL-2017) had also been improperly stored and had been administered. The vaccines experienced the following temperature excursions on the following dates: 21 F for 5 hours. Reportedly, there had been no previous temperature excursions and the aforementioned ones were identified due to a data logger. Furthermore, no product quality complaint was involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Accidental exposure to product, No adverse event, Product quality issue
Clinical narrative: This spontaneous report was received from a health professional, who happens to be also the patient (female patient of unknown age), reporting on herself. Information about the patient's medical history and concurrent conditions was not provided. On an unknown date while opening a dose package of VARIVAX, the reporter noticed that the vial was broken and she got some medication on her hands. No adverse event was reported. A product quality issue was reported because of the broken vial. Additional information has been requested.
Age: 0.27
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a Medical Assistant referring to a twelve weeks and nine days patient of unknown gender. Pertinent medical history and drug reactions allergies were not reported. On 14-JUN-2016, the patient was inadvertently administered the first dose of ROTATEQ, orally (lot number, expiration date and dose were not reported). Concomitant medications were not reported. There were no adverse effects reported. No product quality complaint (PQC) was involved and no further information was provided. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a patient of unknown age and gender. On 09-JUN-2016, the patient was inadvertently vaccinated with expired dose of PROQUAD (lot # K025761 and expiry date: 08-JUN-2016. No adverse effect was reported. No product quality complaint (PQC) was reported from PROQUAD. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Arthralgia, Chills, Fatigue, Headache, Heart rate increased
Clinical narrative: Chills; fever - 102; headache; joint/muscle pain, extreme fatigue; nausea; increased heart rate. Called dr office: recommended fluids, Tylenol, rest; slept for 20 hours; symptoms began to disappear after 36 hours.
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Hypersomnia, Myalgia, Nausea, Pyrexia
Clinical narrative: Chills; fever - 102; headache; joint/muscle pain, extreme fatigue; nausea; increased heart rate. Called dr office: recommended fluids, Tylenol, rest; slept for 20 hours; symptoms began to disappear after 36 hours.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Pain, Pruritus, Rash erythematous
Clinical narrative: Huge bright red rash. Itching that got worse over the next 24 hours. Painful to touch. Rash approximately 5 inches in diameter at injection site.
Age: 1.02
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Pyrexia, Rash generalised
Clinical narrative: High fever 103.5. Raised rash all over body.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Local reaction
Clinical narrative: Local reaction - redness (tennis ball size), no swelling.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site rash, Injection site urticaria
Clinical narrative: Patient presented to the pharmacy in the evening to show me a rash that had developed around the injection site.  It looked like a hive.  He said it was not painful, but did occasionally itch.  I recommended Claritin for the itch and IBU if it became painful.  He was instructed to contact his doctor if it worsened or he had any difficulty breathing.  I followed up with the patient today and he said the rash was getting smaller.
Age: 0.8
Sex: M
Vaccine: DTAPHEPBIP, PNC13
Symptoms: Injection site urticaria, Lethargy, Pallor, Pyrexia, Urticaria
Clinical narrative: The evening of the vaccine, patient developed a 102 fever and vomited, was pale and lethargic.  On 06/18/2016, she developed hives and as of today 06/19/2016, she just has hives around the injection site.
Age: 0.8
Sex: M
Vaccine: DTAPHEPBIP, PNC13
Symptoms: Vomiting
Clinical narrative: The evening of the vaccine, patient developed a 102 fever and vomited, was pale and lethargic.  On 06/18/2016, she developed hives and as of today 06/19/2016, she just has hives around the injection site.
Age: 5.0
Sex: M
Vaccine: MMRV
Symptoms: Lymphadenopathy
Clinical narrative: Severely swollen lymph nodes on the side of his neck.
Age: 73.0
Sex: F
Vaccine: PNC13, TDAP
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: PATIENT PRESENTED WITH REDNESS AT SITE OF INJECTION ON RIGHT DELTOID WHRE Tdap was admistered. AREA LOOKS RED AND IS SLIGHTY WARM TO THE TOUCH AND ITCHES, BUT PATIENT DOES NOT REPORT ANY PAIN. THERE IS NO SWELLING.
Age: 58.0
Sex: M
Vaccine: TYP
Symptoms: Urticaria
Clinical narrative: Hives on lower back, stretching horizontally under ribs.
Age: 24.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Large red swelling on the arm that received the shot. The swelling grew rapidly to reach from shoulder to elbow. Went to urgent care, where the doctor diagnosed it as cellulitis and prescribed antibiotics.
Age: 58.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Erythema, Injection site pain, Injection site swelling, Injection site warmth, Local reaction
Clinical narrative: Local reaction on left arm, pain, swelling, bright brightness, traveling down the arm. Vaccine given on 6/15/16. The patient still has red swollen area around her elbow. The site of injection is better but sore but swelling is traveling down and feels hot and sore.
Age: 58.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Local reaction on left arm, pain, swelling, bright brightness, traveling down the arm. Vaccine given on 6/15/16. The patient still has red swollen area around her elbow. The site of injection is better but sore but swelling is traveling down and feels hot and sore.
Age: 58.0
Sex: F
Vaccine: TDAP
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 26.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site rash, Injection site urticaria, Pain in extremity
Clinical narrative: 2 days after injection, pt. complained of welts/rash on arm where injection occurred. Still complaining today of arm being so sore. She can't lie on it. Rash/welts still present.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Information regarding relevant medical history and concurrent condition were not reported. On an unknown date the patient was vaccinated with an improperly stored dose of VARIVAX (lot # L025208, expiration date 07-JUL-2017, route not specified). No adverse effects reported. Additional information is not expected because there was not consent for follow up.
Age: 43.0
Sex: F
Vaccine: PPV
Symptoms: Unevaluable event
Clinical narrative: This solicited report, was received from a 43 year old consumer, as part of Marketing Research Program, concerning to an unspecified number of patients (reported as "too many") whose concurrent conditions, medical history and concomitant medications were not provided. On unknown dates, the patients were vaccinated with doses of Pneumococcal Vaccine, Polyvalent (23-valent) (manufacturer unknown) (strength, dose schedule, route of administration, lot numbers or expiration dates were not provided). The patient stated that she did not get vaccinations shots since too many people she knows have gotten sick from them. She usually just took precautions to try and stay away from getting vaccines. Additional information is not expected as the reporter did not wish to be contacted.
Sex: U
Vaccine: HEP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and gender. On 01-JUN-2016 the patient was vaccinated with fourth dose of RECOMBIVAX HB (dose was unknown, lot # L048236, expiry date: 31-MAR-2018 intramuscular) (extra dose administered). No adverse effects were reported.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report has received from a Medical Assistant referring to a patient of unknown age and unknown gender. Information about concurrent condition, concomitant medication and medical history was not provided. On 14-JUN-2016, the patient received an expired dose PNEUMOVAX 23 (lot # K019561, expiration date 20-APR-2016, dose and frequency were unknown) intramuscularly. No known adverse effects were reported. Additional information has been requested.
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Blood test, Dizziness, Eye movement disorder, Feeling hot, Urine analysis
Clinical narrative: Information has been received from a nurse referring to a male patient of unknown age. On 01-JUN-2016 at 9:30 during the same office visit the patient was vaccinated with GARDASIL 9 (intramuscular; strength, lot# dosage and frequency unspecified), diphtheria toxoid, pertussis acellular vaccine (unspecified), TDAP (strength, lot#, dosage, frequency and route unspecified) and MENACTRA (strength, lot# dosage, frequency and route unspecified). The nurse reported that by 19:00 on the same day, the patient experienced feeling hot, vomiting, eyes rolling back and light headed. The nurse reported that the patient sought medical attention at the emergency room, but was no admitted. The nurse reported that treatment was prescribed by an unspecified provider described as on ZOFRAN intravenous push 4 mg for a one time dose during ER visit. In addition during the ER visit on 01-JUN-2016, a urine specimen was taken and blood was drawn, both of which specific test was unspecified. The nurse reported that the patient had recovered on 02-JUN-2016. The causality was not reported. Additional information has been requested.
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Vomiting
Clinical narrative: Information has been received from a nurse referring to a male patient of unknown age. On 01-JUN-2016 at 9:30 during the same office visit the patient was vaccinated with GARDASIL 9 (intramuscular; strength, lot# dosage and frequency unspecified), diphtheria toxoid, pertussis acellular vaccine (unspecified), TDAP (strength, lot#, dosage, frequency and route unspecified) and MENACTRA (strength, lot# dosage, frequency and route unspecified). The nurse reported that by 19:00 on the same day, the patient experienced feeling hot, vomiting, eyes rolling back and light headed. The nurse reported that the patient sought medical attention at the emergency room, but was no admitted. The nurse reported that treatment was prescribed by an unspecified provider described as on ZOFRAN intravenous push 4 mg for a one time dose during ER visit. In addition during the ER visit on 01-JUN-2016, a urine specimen was taken and blood was drawn, both of which specific test was unspecified. The nurse reported that the patient had recovered on 02-JUN-2016. The causality was not reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health care professional refers to multiple unspecified patients of unknown age and gender. On unknown dates, unspecified number of unspecified patients received improperly stored GARDASIL-9, (lot # L016428; 30-JUL-2017) at a temperature of 30 F for 24 hours. No previous temperature excursion was reported and the data logger was involved. No adverse effects were reported. The outcome of the events was unknown. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPVX, MNQ, VARCEL
Symptoms: Nausea, Vomiting
Clinical narrative: Case number PHHY2011US115125 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS: 418809) website on 09 Jun 2011. This report refers to a 17 year old female patient. The patient's medical history included mild URI symptoms which includes runny nose, mild cough and sore throat. The patient was vaccinated with MENVEO (batch number: unknown) intramuscularly, HPV4 (other manufacturer, batch number: unknown) intramuscularly in right arm and VARCEL (other manufacturer, batch number: unknown) on 03 Mar 2011. On 03 Mar 2011, the patient experienced nausea, vomiting that persisted for a week. The outcome of events was reported as complete recovery. Following internal review on 07 Apr 2012 for the information received on 09 Jun 2011, the following correction was done: The event listedness of vomiting was changed from listed to unlisted.
Age: 14.0
Sex: M
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: Injection site haemorrhage, Petechiae
Clinical narrative: Case number PHHY2011US115034 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS: 422284) website on 06 Jul 2011. This report refers to 14 year old male patient. The patient was vaccinated with MENVEO (batch number: 024011) in left arm, HEPA (batch number: AHAVB469AA) in left arm, VARCEL (other manufacturer, batch number: 1327Z) subcutaneously in right arm and Tdap (other manufacturer, batch number: AC52B044CA) in right arm on 15 Mar 2011. On 15 Mar 2011, the patient developed petechiae on left arm. The outcome of events was reported as complete recovery. Following internal review on 07 Apr 2012 for the information received on 06 Jul 2011, the following correction was done: the event listedness of injection site haemorrhage was changed from listed to unlisted.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Abdominal discomfort, Cold sweat, Injection site erythema, Injection site rash, Injection site reaction
Clinical narrative: Case number PHHY2011US114863 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS: 423959) website on 03 Aug 2011. This report refers to 18 year old female patient. The patient's medical history included hives with MOTRIN, amoxicillin, eggs, peanuts, and previous vaccination with VARIVAX. The patient was vaccinated with MENVEO (batch number: A100034) intramuscularly in left arm on 18 May 2011. On 18 May 2011, the patient experienced warm, erythematous raised 7.0 x 5.5 cm lesion at site of injection on (L) upper arm. She was sick, had upset stomach and clammy skin within 2 hours after vaccination. She developed rash at injection site within 6 hours which reached above diameter by next morning. The outcome of events was reported as condition unchanged as of 19 May 2011. Following internal review on 07 Apr 2012 for the information received on 03 Aug 2011, the following correction was done: The event skin lesion was deleted.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site warmth, Malaise, Skin lesion
Clinical narrative: Case number PHHY2011US114863 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS: 423959) website on 03 Aug 2011. This report refers to 18 year old female patient. The patient's medical history included hives with MOTRIN, amoxicillin, eggs, peanuts, and previous vaccination with VARIVAX. The patient was vaccinated with MENVEO (batch number: A100034) intramuscularly in left arm on 18 May 2011. On 18 May 2011, the patient experienced warm, erythematous raised 7.0 x 5.5 cm lesion at site of injection on (L) upper arm. She was sick, had upset stomach and clammy skin within 2 hours after vaccination. She developed rash at injection site within 6 hours which reached above diameter by next morning. The outcome of events was reported as condition unchanged as of 19 May 2011. Following internal review on 07 Apr 2012 for the information received on 03 Aug 2011, the following correction was done: The event skin lesion was deleted.
Age: 15.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Erythema, Induration, Pruritus
Clinical narrative: Case number PHHY2011US114901 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS: 425174) website on 03 Aug 2011. This report refers to 15 year old female patient. The patient was vaccinated with MENVEO (batch number: 1000026) intramuscularly in left arm, Tdap (other manufacturer, batch number: C3517BA) intramuscularly in left arm and VARCEL (other manufacturer, batch number: 11787) subcutaneously in right arm on 07 Jun 2011. On 07 Jun 2011, the patient developed 4 cm x 3 cm pruritic, erythematous induration area. The outcome of events was reported as complete recovery. Following internal review on 07 Apr 2012 for the information received on 03 Aug 2011, the following correction was done: the events erythema and induration were separately coded (initially induration erythema was coded).
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Discomfort, Injection site erythema, Injection site induration, Injection site warmth, Pain
Clinical narrative: Case number PHHY2011US114919 is an initial spontaneous report received from vaccine adverse event reporting system (VAERS reference number: 425446) website on 06 Sep 2011. This report refers to an 11-year-old male patient. His medical history and concomitant medication were not reported. He was vaccinated with MENVEO (batch number: A10049) intramuscularly on to left arm, diphtheria/ tetanus/ acellular pertussis vaccine (other manufacturer, batch number: C3577AA) intramuscularly on to right arm, varicella virus vaccine (other manufacturer, batch number: 1310Z) subcutaneously on to left arm on 14 Jun 2011. On the same day he experienced hard, red and warm induration at injection site and he was very uncomfortable due to pain. The patient did not visit emergency room. The outcome of the events was not reported. Following an internal non serious line listing review on 07 Apr 2012 of the data received on 06 Sep 2011, it was observed that discomfort was erroneously captured as an event in this case and therefore the event was deleted from this case.
Age: 12.0
Sex: M
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site oedema, Injection site reaction, Injection site warmth, Skin reaction
Clinical narrative: Case number PHHY2011US114959 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 425939) web site on 06 Sep 2011. This report refers to a 12-year-old male patient. His medical history and concomitant medication were not reported. He was vaccinated with MENVEO (batch number: A100033) intramuscularly on to left arm, VARIVAX (other manufacturer, batch number: 1563Z) subcutaneously on to right arm, GARDASIL (batch number: 0565Z) intramuscularly on to left arm and ADACEL (batch number: C3517AA) intramuscularly on to right arm on 20 Jun 2011. On 21 Jun 2011 his injection site became erythematous about 2 inches and was warm to touch with slight oedema. It was reported that he only had a mild skin reaction in the injection site. He did not visit emergency room. The outcome of the events was not reported. Following an internal non serious line listing review on 07 Apr 2012 of the data received on 06 Sep 2011, it was observed that vaccination site reaction was erroneously captured as an event in this case and therefore the event was deleted.