chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 56.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site paraesthesia, Injection site pruritus
Clinical narrative: Patient states that injection site started itching/burning/tingling. Area was very red and hard. She cam to the pharmacy 2 days later to show me. And indeed, I felt the area and it was hard, raised, feverish feeling and maybe 2 inches across. I advised her to take BENADRYL by mouth and use cool compress. Injection site reactions arm common. But this RXN appeared worse than most.
Age: 56.0
Sex: M
Vaccine: FLU4
Symptoms: Pyrexia
Clinical narrative: Patient states that injection site started itching/burning/tingling. Area was very red and hard. She cam to the pharmacy 2 days later to show me. And indeed, I felt the area and it was hard, raised, feverish feeling and maybe 2 inches across. I advised her to take BENADRYL by mouth and use cool compress. Injection site reactions arm common. But this RXN appeared worse than most.
Age: 2.0
Sex: M
Vaccine: FLU4
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Pain
Clinical narrative: Pain when elevating arm above 90 degrees since date of administration of vaccine. Patient saw MD w/MRI scheduled.
Age: 58.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Condition aggravated, Seizure
Clinical narrative: Pt (who is taking medication for seizures) is experiencing a seizure plus/minus every 2 hours according to her mother.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Burning sensation, Injection site erythema, Injection site pain, Injection site reaction, Injection site warmth
Clinical narrative: Received flu vaccine 10/25/16 in (L) deltoid. Site was warm to touch, burning sensation, painful and had a raised red area where vaccine was given the size of a 50 cent piece-per patient. She came to clinic on 10/26 and informed us of this. She said she felt a little nauseated. On 10/27 she said she was much better the site not as red or warm and was down to 25 cent size. Used cool compresses.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea
Clinical narrative: Received flu vaccine 10/25/16 in (L) deltoid. Site was warm to touch, burning sensation, painful and had a raised red area where vaccine was given the size of a 50 cent piece-per patient. She came to clinic on 10/26 and informed us of this. She said she felt a little nauseated. On 10/27 she said she was much better the site not as red or warm and was down to 25 cent size. Used cool compresses.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Musculoskeletal pain, Pain in extremity
Clinical narrative: Pain in the left buttock/left leg.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Bone pain, Pain in extremity
Clinical narrative: Patient had a flu shot 1 week ago and is still experiencing major pain in her clavicle area and cannot lift her arm. The pain is not subsiding, but not getting worse. Ibuprofen helps slightly. I referred her to her doctor.
Age: 73.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Pain, Pyrexia, Skin warm
Clinical narrative: Pain, redness, warmth, fever-Patient requested both vaccines in same arm.
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Chest discomfort, Pharyngeal oedema
Clinical narrative: 1700 - chest tightness, swollen throat 1800 - BENADRYL 2 tabs PO 1930 IV established, Ranitidine 50 mg IV, SOLUMEDROL 62.5mg IV BENADRYL 25mg IV 2100 - much improved, lungs and throat clear O2Sat 95 percent RA P-101 T 98.2 R-22 BP 138/82.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Dry eye, Dry skin, Eye pruritus, Headache
Clinical narrative: I experienced a severe headache. Even though I didn't take my temperature I am sure I had a fever. I also had aches, chills, and itchy dry eyes and skin. This lasted at least two days (the two days after receiving the vaccine). Never had this happen before.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Pain, Pruritus, Pyrexia
Clinical narrative: I experienced a severe headache. Even though I didn't take my temperature I am sure I had a fever. I also had aches, chills, and itchy dry eyes and skin. This lasted at least two days (the two days after receiving the vaccine). Never had this happen before.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Joint range of motion decreased, Musculoskeletal pain, Musculoskeletal stiffness, Pain
Clinical narrative: Felt the injection unexpectedly. Upper arm and shoulder were sore the first week. Same arm/shoulder was stiff, limited range of motion with pain. Primary care Doctor recommended not rubbing and giving it time. Finally, Doctor prescribed NSAID because the symptoms continued.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Felt the injection unexpectedly. Upper arm and shoulder were sore the first week. Same arm/shoulder was stiff, limited range of motion with pain. Primary care Doctor recommended not rubbing and giving it time. Finally, Doctor prescribed NSAID because the symptoms continued.
Age: 6.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Injection site bruising, Injection site discolouration, Nodule, Peripheral swelling
Clinical narrative: The day after flu vaccine was administered, patient's mother noticed "huge red knot 4-5 inches in diameter". BENADRYL and ibuprofen given 10/19. Arm stayed swollen for 7-10 days after injection, site "turned purpley, like a bruise".
Age: 79.0
Sex: M
Vaccine: FLU3
Symptoms: Chest pain, Injection site pain, Respiratory tract congestion
Clinical narrative: Patient reported pain at injection site, achiness across chest and back and congestion starting about 1 week after vaccine. Comes and goes, but feels like it's getting better. Takes Ibuprofen to help.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Chest pain, Injection site pain, Muscle tightness, Respiratory tract congestion
Clinical narrative: Patient experienced pain at injection site, chest pain, and back pain as well as muscle tightness and chest congestion starting about 1 week after receiving vaccination. She doesn't feel like its getting any better.
Age: 59.0
Sex: F
Vaccine: FLUC4
Symptoms: Rash erythematous
Clinical narrative: Red rash both arms and chest - patient has been taking BENADRYL OTC, she is seeing improvement. Advised to see primary Dr if no further improvement 2-3 days.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Pruritus
Clinical narrative: Patient states he was itching from shot. He then said he would take CLARITIN for it.-Followed up and he said itchiness "comes and goes" but its still there and he thinks from shot.
Age: 22.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site rash, Injection site urticaria, Rash generalised, Urticaria
Clinical narrative: Flu vaccine administer subQ and not IM to right arm. Developed hives/rash to injection site and body. Hives x 4 days. Saw provider on 11-1-16. OTC meds taken.
Sex: U
Vaccine: HEPA
Symptoms: Opiates positive, Somnolence
Clinical narrative: Information has been received from an unspecified healthcare worker from a physician's office, via a company representative, referring to a patient of unknown age and gender. Information regarding relevant medical history, concurrent condition and concomitant medications were not reported. On an unknown date, the patient was vaccinated with a dose of hepatitis  A  vaccine, inactivated (manufacturer unknown) (dosage, route and lot # not specified). It was reported that the patient was administered the vaccine, then went home and went to sleep and did not wake up. The patient was taken to the emergency room and was found to be opiate positive (it was unspecified what kind of tests were performed). The outcome of the events was unknown. Upon internal review, the event of "went to sleep and did not wake up" was considered to be medically significant. Additional information is not expected because we are not allowed to contact the physician.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Peripheral swelling, Pruritus
Clinical narrative: Left arm swelled up within a few hours of receiving vaccine. The patient treated with ice. The swelling went down after 3 days but was left with red, itchy arm. She is taking cetirizine to treat the pruritus.
Age: 4.0
Sex: M
Vaccine: FLU4, MMRV
Symptoms: Erythema, Injection site erythema, Injection site pruritus, Injection site reaction, Pruritus
Clinical narrative: About 45 min after injection, patient returned to office because area of influenza vaccine was red, blotchy and pruritic. Extended from deltoid injection site to chest advised ZYRTEC 5 mg. About 36 H later, he complained of tongue itching so went to ER for eval - Given BENADRYL.
Age: 4.0
Sex: M
Vaccine: FLU4, MMRV
Symptoms: Rash macular, Tongue pruritus
Clinical narrative: About 45 min after injection, patient returned to office because area of influenza vaccine was red, blotchy and pruritic. Extended from deltoid injection site to chest advised ZYRTEC 5 mg. About 36 H later, he complained of tongue itching so went to ER for eval - Given BENADRYL.
Age: 0.58
Sex: F
Vaccine: HIBV, HIBV
Symptoms: Agitation, Decreased eye contact, Hypotonia, Infantile vomiting, Lethargy
Clinical narrative: Received PEDVAX vaccine 11/3/16. Approx 5 hours later when waking from nap vomited. Then vomited several times, became pale, limp, lethargic. Parents called 911. 15 minutes into ambulance ride back to baseline. Was admitted for 24hr observation.
Age: 0.58
Sex: F
Vaccine: HIBV, HIBV
Symptoms: Pallor
Clinical narrative: Received PEDVAX vaccine 11/3/16. Approx 5 hours later when waking from nap vomited. Then vomited several times, became pale, limp, lethargic. Parents called 911. 15 minutes into ambulance ride back to baseline. Was admitted for 24hr observation.
Age: 0.58
Sex: F
Vaccine: HIBV, HIBV
Symptoms: Hypotonia, Lethargy, Pallor, Vomiting
Clinical narrative: Received PEDVAX vaccine 11/3/16. Approx 5 hours later when waking from nap vomited. Then vomited several times, became pale, limp, lethargic. Parents called 911. 15 minutes into ambulance ride back to baseline. Was admitted for 24hr observation.
Sex: U
Vaccine: HPVX
Symptoms: Fatigue, Incorrect product storage
Clinical narrative: Information has been received from a physician referring to a patient of unknown age and gender. The patient's medical history, concomitant therapy and concurrent condition were not provided. On 27-JUL-2016, the patient was vaccinated with a dose of improperly stored human papillomavirus (HPV) vaccine (manufacturer unknown) (dose, route, lot number and expiration date were unknown), which was exposed to temperature excursion. On an unknown date in 2016, the patient experienced fatigue, which lasted for 2 days. The patient recovered from fatigue on an unspecified date in 2016. The causality between fatigue and HPV vaccine (manufacturer unknown) was not provided. This is one of several reports that received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to a patient of unknown age. The medical history, concurrent conditions and concomitant medications were no reported. On 03-NOV-2016, the patient was vaccinated with an expired dose of RECOMBIVAX HB lot # K014190, 24-OCT-2016 intramuscular. No adverse effect reported. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a registered nurse via a company representative referring to an 80 year old male patient. Information regarding concomitant medication, medical history and drug reactions/allergies was unknown. On an unknown date (reported as "a few years ago"), the patient was vaccinated with a dose of ZOSTAVAX (lot #, expiration date, dose and route were not reported). On an unknown date, the patient was diagnosed with shingles. The patient contacted the nurse seeking medical attention. Treatment was given for the event and the patient recovered on an unknown date. The causality between the event and ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 27-OCT-2016, the patient was vaccinated with a dose of improperly stored ZOSTAVAX 19400 PFU (lot # M032360, expiration date 18-AUG-2017, dose not reported) subcutaneously. The dose of vaccine was improperly stored at 30 degree Fahrenheit for 1 hour. There was no previous temperature excursion. No data logger was involved. No adverse effects were reported. This is one of two reports received from same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 27-OCT-2016, the patient was vaccinated with a dose of improperly stored ZOSTAVAX 19400 PFU (lot # M032360, expiration date 18-AUG-2017, dose not reported) subcutaneously. The dose of vaccine was improperly stored at 30 degree Fahrenheit for 1 hour. There was no previous temperature excursion. No data logger was involved. No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: General symptom, Herpes zoster
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 73-year-old female patient. The patient had no pertinent medical history. The patient's concurrent condition included unspecified reaction to angiotensin-converting-enzyme (ACE) inhibitors. On 11-JUL-2014, the patient was vaccinated with the first dose of ZOSTAVAX (lot # L046893, expiration date: 23-FEB-2017), subcutaneously. Concomitant therapies included simvastatin (manufacturer unknown), Losartan potassium (manufacturer unknown), hydrochlorothiazide, BYSTOLIC, Loratadine, clopidogrel and meloxicam. On 03-OCT-2016, the patient developed an unspecified symptom. On an unknown date in approximately 2016, the patient was diagnosed with shingles (an unspecified location of the body), by unspecified healthcare professional. No treatment was given for the adverse events. The outcome of the events was reported as recovering. The relatedness between the events and ZOSTAVAX was not 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 an unspecified reporter refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with the improperly stored (-13 degrees Celsius for 8 hours) doses of VARIVAX (lot # K026385 with expiration date 15-DEC-2016, lot # M006156 with expiration date 05-FEB-2018, lot # M006726 with expiration date 08-FEB-2018 and lot # M010482 with expiration date 01-MAR-2018; dose and route of administration were not reported). No adverse effects were reported. Additional information is not expected as the reporter did not wish to be contacted.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant referring to unspecified number of patients of unknown age and gender. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On an unknown date, the patients were vaccinated with improperly stored dose of GARDASIL 9 (dosing details were not reported) lot # L043214, expiry date: 30-AUG-2017. It was reported that the vaccines were exposed to a temperature of 0.7C during a time frame of 2 hours. No previous temperature excursion was reported. No adverse effects were reported. There were no product quality complaints (PQC) involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus
Clinical narrative: Information has been received on 27-OCT-2016 from a pharmacist regarding a 60 year old female with morphine related reactions. Patient received ZOSTAVAX (lot# L028283, expiration date 28-OCT-2016) subcutaneous in the left arm on 25-OCT-2016. "A day later" patient noticed redness in an elongated shape near the injection site. Yesterday, she noticed that the "redness got bigger and elongation is now 2-3 inches long and itches". Patient sought medical attention and call pharmacist. Patient received unspecified treatment for her adverse event. Patient's present status was not recovered. No additional information. Additional information has been requested.
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Incorrect product storage, Pain in extremity, Tenderness
Clinical narrative: This spontaneous report as received from a consumer refers to her son: a male patient of unknown age. On an unknown date, the patient was vaccinated with the first dose of GARDASIL 9 (dose and route was not reported, lot # M014929). Concomitant therapies included MENACTRA. On an unknown date, the patient experienced a sore tender arm following the vaccination. The primary reporter stated that her son's physician stated that the dose of GARDASIL 9 that was administered was improperly stored. The outcome of the events was not reported. Causality assessment was not reported. Additional information is not expected as no follow up can be obtained from the physician.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 lot # M006141, expiration date 28-MAY-2017 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 67 degrees Fahrenheit for 6 hours 30 minutes. Data logger was involved. There were no previous excursions reported. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Allergy to vaccine
Clinical narrative: This spontaneous report as received from a consumer via manufacturer (manufacturer control# 16K-163-1721491-00) refers to a currently 51-year-old male patient. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX 23 injection (dose, route of administration, expiration date and lot number were not reported). Concomitant medications were not reported. On an unknown date, the patient experienced allergy to the vaccine. The outcome of the event was not reported. The event of allergy to the vaccine was considered to be related to PNEUMOVAX 23 by the reporter. This is one of two reports received from the same reporter and concerning the same patient. Additional information is not expected as there were no contact details provided.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site nodule
Clinical narrative: Information has been received from a pharmacist via a company representative referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concomitant medication were unknown. On an unknown date, the patient was vaccinated with ZOSTAVAX (dose, route, lot # and expiration date were unknown). On an unknown date, after an unspecified amount of time of administration, the patient notified the pharmacist that there was a knot at the injection site and it had been there for a few weeks. The patient called the pharmacist to seek medical attention. The outcome of the event was unknown. The causality assessment was not provided. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist (also reported to be a registered nurse) refers to a patient of unknown age and gender. No pertinent medical history, drug reactions/allergies or concurrent conditions were reported. On 07-NOV-2016, the patient was vaccinated with an expired dose of PNEUMOVAX 23 (which had a lot # L022262 and an expiration date of 05-NOV-2016; however, the dose, dosage number, anatomical location and route of administration were unknown). No concomitant therapies were reported. Despite being vaccinated with an expired dose, the patient developed no adverse effects and no product quality complaint was involved. Additional information has been requested.
Sex: F
Vaccine: MMR
Symptoms: Rash, Urticaria
Clinical narrative: Information has been received on 27-OCT-2016 from a female patient's mother, who was also a registered nurse, regarding her daughter (age unknown) who received (Wistar RA 27-3) M-M-R II subcutaneous (date not reported). The patient's mother reported to a field employee that the patient developed a "rash" 14 days after vaccination of (Wistar RA 27-3) M-M-R II (date not reported). The patient developed "hives on her back that traveled to legs and head: (date not reported) and the "hives continued for 12 hours and resolved". Patient sought medical attention with an office visit. Patient's present status was recovered. No other adverse information was reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered
Clinical narrative: This spontaneous report was received from a physician via a company representative and refers to a patient of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications and drug reactions or allergies was reported. On an unknown date in August 2016, the patient was vaccinated with an expired dose of PNEUMOVAX 23 injection, expiry date in July 2016 (dose, route of administration, anatomical location and lot # were not specified). This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered
Clinical narrative: This spontaneous report was received from a physician via a company representative and refers to a patient of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications and drug reactions or allergies was reported. On an unknown date in October 2016, the patient was vaccinated with an expired dose of PNEUMOVAX 23 injection, expiry date in July 2016 (dose, route of administration, anatomical location and lot # were not specified). This is one of two reports received from the same reporter. Additional information has been requested.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Induration, Rash erythematous, Rash pruritic, Swelling
Clinical narrative: This spontaneous report was received from a 54 year old female patient regarding herself. Concomitant medications included SINGULAIR, levothyroxine, an unspecified blood pressure medication, an unspecified diabetes/weight loss medication and an unspecified steroid for "eyes". Concurrent medical conditions included high blood pressure and hepatitis C carrier. She had no drug reactions/allergies. On 18-OCT-2016, the patient received ZOSTAVAX subcutaneously (lot number unknown). On 19-OCT-2016, the patient developed a swollen, big hard red rash that itched after receiving ZOSTAVAX. No treatment was given. She did speak with a pharmacist (not further specified). The event was not recovered. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a 6 week old patient of unknown gender. The patient's medical history, concurrent condition and concomitant medication were unknown. On 29-AUG-2016, the patient was vaccinated with the pediatric formulation of VAQTA (Inappropriate schedule of vaccine administered) (0.5 ml, lot # M003011, expiration date: unknown) intramuscularly. No adverse effects were reported. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Erythema, Injection site pain, Injection site swelling, Peripheral swelling, Skin discolouration
Clinical narrative: This initial report was received from a 69 year old male patient, reporting himself. the patient did not have pertinent medical history, drug reactions or allergies. The patient's concomitant medications were not reported. On 31-OCT-2016, the patient was vaccinated with PNEUMOVAX 23, in the deltoid muscle of the left arm (dose, strength, route of administration and lot number were not reported). On the same date after the vaccine application, the patient started to have "lots of injection site pain, swelling and his left arm was turning red". On 01-NOV-2016, the patient stated that his arm was "blowing up pretty good, still red and hot to the touch". On 02-NOV-2016, the patient went to the physician; he was directed to put cold compresses on the arm and take BENADRYL, laboratory diagnostics studies were not performed. On 03-NOV-2016, the patient stated that he will still having the adverse experiences and his arm was "turning brown". At the reporting time, the outcome of erythema, injection site pain, injection site swelling, peripheral swelling, skin discolouration and skin warm was reported as not recovered. The reporter did not assess the causal relationship between the reported events and vaccination with PNEUMOVAX 23. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Skin warm
Clinical narrative: This initial report was received from a 69 year old male patient, reporting himself. the patient did not have pertinent medical history, drug reactions or allergies. The patient's concomitant medications were not reported. On 31-OCT-2016, the patient was vaccinated with PNEUMOVAX 23, in the deltoid muscle of the left arm (dose, strength, route of administration and lot number were not reported). On the same date after the vaccine application, the patient started to have "lots of injection site pain, swelling and his left arm was turning red". On 01-NOV-2016, the patient stated that his arm was "blowing up pretty good, still red and hot to the touch". On 02-NOV-2016, the patient went to the physician; he was directed to put cold compresses on the arm and take BENADRYL, laboratory diagnostics studies were not performed. On 03-NOV-2016, the patient stated that he will still having the adverse experiences and his arm was "turning brown". At the reporting time, the outcome of erythema, injection site pain, injection site swelling, peripheral swelling, skin discolouration and skin warm was reported as not recovered. The reporter did not assess the causal relationship between the reported events and vaccination with PNEUMOVAX 23. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: PPV
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Information has been received from an office manager referring to an 1 year old female patient. The patient's medical history, concurrent condition and concomitant therapy were not reported. On an unknown date, the one-year-old patient might have been given a dose of PNEUMOVAX 23 (lot #, expiration date, dose and route were not reported) (product use in unapproved population). It was also reported that the reporter was not sure if the patient received PNEUMOVAX 23 or instead PREVNAR 13 (manufacturer unknown). No adverse effect was reported. Additional information is not expected as there is no consent for follow up.
Sex: U
Vaccine: HPV4
Symptoms: Interchange of vaccine products, No adverse event, Product use issue
Clinical narrative: Information has been received from a medical assistant referring to a patient of unknown age and gender. Information about concurrent condition, medical history and concomitant medication was not provided. The medical assistant reported that the patient received GARDASIL intramuscularly on 28-AUG-2012 (lot # 1745AA with expiration date 09-MAY-2013; dose unknown) and on 13-JUN-2013 (lot# H021346 with expiration date 01-OCT-2015; dose unknown) and received GARDASIL 9 intramuscularly on 04-AUG-2016 (lot# L043214 with expiration date 30-AUG-2017; dose unknown) and on 26-OCT-2016 (lot#M030380 with expiration date 01-FEB-2019; dose unknown. No adverse effects were reported. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to male patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX (subcutaneous, once; lot #, strength, dosage and frequency unspecified) (extra dose administered). Then the patient's wife told the patient that he already had vaccine a few years ago. No adverse effects were reported. Additional information is not expected as there was no consent to contact the physician.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a medical assistant via field representative refers to unspecified patients of unknown gender and age. There was no information regarding the patients' medical history, concurrent conditions, drug reactions/allergies and concomitant medications. On unknown dates, the patients were vaccinated with ZOSTAVAX (dosing details were not provided). On unknown dates, the patients complained of shingles. Medical assistant reported that according to a protocol at an unspecified clinic, for patients who experience shingles after receiving ZOSTAVAX were to be administered with a booster dose of the same vaccine. The representative was unaware whether or not the adverse experience of shingles after vaccination has ever been reported, nor does he now how many patients received a booster dose of ZOSTAVAX. He also reported that currently at the time of this report, there were no patients experiencing shingles after the receipt of ZOSTAVAX. Outcome of the event was unknown. Causality assessment was not provided. 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 medical assistant refers to unspecified number of patients of unknown age and gender. The patients' medical history, current conditions and concomitant medications were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of ROTATEQ, lot # L042215 expiry date: 02-AUG-2017 (route and dose were not reported). The vaccine was exposed to a temperature frame of -0.5 degrees centigrade for a duration of 5 hours 38 minutes. There were no previous excursions. The call was because of a data logger. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports received form the same reporter. 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 medical assistant refers to unspecified number of patients of unknown age and gender. The patients' medical history, current conditions and concomitant medications were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # L024993 and expiry date: 17-OCT-2017 (route and dose were not reported). Other suspect therapies included PEDVAXHIB (route and dose were not reported), lot # M001813 and expiry date: 14-OCT-2018 and ROTATEQ, lot # L042215 expiry date: 02-AUG-2017 (route and dose were not reported). The vaccine was exposed to a temperature frame of -0.5 degrees Centigrade for a duration of 5 hours 38 minutes. There were no previous excursions. The call was because of a data logger. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Erythema, Hypersensitivity, Peripheral swelling
Clinical narrative: Information has been received from an unspecified type reporter from doctor's office via Pfizer referring to a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant medication were not reported. On an unknown date in 2006 the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (dose, route, lot # and expiration date were unknown). On an unknown date the patient experienced a pretty severe allergic reaction, her arm was red and swollen. Outcome of the event was unknown. The reporter considered the allergic reaction to be related to Pneumococcal Vaccine, Polyvalent (23-valent) (manufacturer unknown). Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to unspecified number of patients of unknown age and gender. The patients' medical history, current conditions and concomitant medications were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of PEDVAXHIB (route and dose were not reported), lot # M001813 and expiry date: 14-OCT-2018. The vaccine was exposed to a temperature frame of -0.5 degrees centigrade for a duration of 5 hours 38 minutes. There were no previous excursions. The call was because of a data logger. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed clinical social worker referring to an unspecified number of patients of unknown ages and genders. The patients' medical history, concurrent condition and concomitant therapy were not reported. On unknown dates, the patients might have been administered improperly stored VAQTA injection (lot # M015290, expiration date 20-SEP-2017; dose and route were unknown). The vaccines were stored under temperature 11 Celsius degree for 17 days. There was no previous temperature excursion. Digital data logger was involved. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed clinical social worker referring to an unspecified number of patients of unknown ages and genders. The patients' medical history, concurrent condition and concomitant therapy were not reported. On unknown dates, the patients might have been administered improperly stored RECOMBIVAX HB (lot # L007558, expiration date 10-NOV-2016; dose and route were unknown). The vaccine were stored under temperature 11 Celsius degree for 17 days. There was no previous temperature excursion. Digital data logger was involved. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.17
Sex: M
Vaccine: RV1
Symptoms: Diarrhoea
Clinical narrative: Diarrhea started evening after immune, same day on 11/08/16: still ongoing to get CBC/Stool Cx/WBC instead.
Age: 1.58
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Localized red/warm/hard area at inj site (L) leg. No fever. 2" in diameter.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to nine unspecified patients of unknown age and gender. Patients' medical history, concurrent conditions and concomitant medication were not provided. The Registered Nurse reported that between 09-MAY-2016 and 31-OCT-2016, the patients were vaccinated with improperly stored VARIVAX injection (subcutaneously, lot # L013063, expiration date 14-APR-2017). Strength and dose number were not provided. No adverse effects were reported. It was reported that there were 4 temperature excursions: on 09-MAY-2016, 20 degrees F for 1 hour 54 minutes; 06-JUL-2016, 15 degrees F for 1 hour 15 minutes; on 18-OCT-2016, 32 degrees F for 40 minutes; and on 28-OCT-2016, 6 degrees F for 17 minutes. Data logger was involved. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Urticaria
Clinical narrative: This spontaneous report as received from the patient's daughter refers to her 79 year old mother. The patient's medical history included herpes zoster in 2012 (reported as 4 years ago). Her concurrent conditions included iodine and penicillin (unspecified) allergy, diabetes, abnormal blood pressure and an unspecified abdominal disorder. Concomitant medications included an unspecified diabetic, an unspecified blood pressure and an unspecified abdominal medications. On 21-MAY-2014 at a local pharmacy, the patient was vaccinated with a dose of ZOSTAVAX (subcutaneously; dose, lot # and expiration date were not reported). Around 27-OCT-2016, the patient developed whelps on her back, which increasingly to spread until 30-OCT-2016. The reporter stated that her mother saw her primary physician on 31-OCT-2016, who confirmed that she had developed shingles again. The patient was given a ten day supply of an unspecified medication (in pill form) and an unspecified cream, to treat her shingles. The reporter did not know if the medications were helping since her mother just received them less than 24 hours ago. None lab diagnostics studies were performed. The outcome of the adverse event was reported as not recovered. The relatedness between the adverse event and ZOSTAVAX was not provided. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a licensed practical nurse via a company representative refers to a 69 year old female patient. The patient's concurrent conditions, medical history and concomitant medications were unknown. On 25-MAR-2009, the patient was vaccinated with ZOSTAVAX, subcutaneously from batch/lot # 01097Y (dose, and expiry date unknown). On 29-NOV-2012, the patient developed shingles. She sought medical attention from a nurse practitioner and received an unspecified treatment for the event. The outcome of shingles was unknown. Causality was not provided by the reporter. No product quality complaint was involved. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Contraindication to vaccination, No adverse event
Clinical narrative: This spontaneous report has been received from a male patient of unknown age, who was reporting on himself. The patient's concurrent conditions included lymphoma. The patient's pertinent medical history, concomitant medications, drug reactions and allergies were not reported. On unspecified date in 2012, the patient was vaccinated with a dose of ZOSTAVAX injection (dose, route of administration, lot# and expiration date were not reported). At the time of vaccination, the patient had lymphoma. It was reported that the patient did not develop shingles after the vaccination. No adverse experience was reported. There was no product quality issue involved. Additional information is not expected as there was no consent to contact the reporter.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site rash
Clinical narrative: Information was received on 20-OCT-2016 from a 55 year old female consumer who was reporting on herself. The patient's medical history included previous episode of shingles. She has a history of "many reactions to unknown medications". The patient was taking concomitant medications but they were not reported. On 19-OCT-2016, the patient received a dose of ZOSTAVAX (lot, dose, route and site were not reported). On 20-OCT-2016, the patient reported that she had a rash around the injection site after receiving ZOSTAVAX. The patient also reported that she was developing a headache. The patient has not yet recovered from the events. The patient did not receive treatment but did speak with a pharmacist. The causality was not specified. The pharmacist had previously reported this information but that case could not be located. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist who refers to herself, a female patient of unknown age. Information on the patient's pertinent medical history, concurrent conditions and drug allergies were not reported. On 29-OCT-2016 the patient was vaccinated with ZOSTAVAX. Concomitant medication were not reported. On 30-OCT-2016, 2 days after onset of therapy, the pharmacist reported she experienced that the injection site was red, warm and slightly painful. The pharmacist reported the redness was the size of a quarter at the injection site and spread to the size of a pear. The pharmacist reported that the redness, warmth and slight pain at the injection site had not resolved. There was no Product Quality Complaint (PQC) involved. No further information was provided. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant referring to unspecified number of patients of unknown age and gender. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On an unknown date, the patients were vaccinated with improperly stored dose of RECOMBIVAX HB lot # M020926, expiry date: 11-AUG-2018 (dosing details were not reported). It was reported that the vaccines were exposed to a temperature of 0.7C during a time frame of 2 hours. No previous temperature excursion was reported. No adverse effects were reported. There were no product quality complaints (PQC) 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 medical assistant referring to unspecified number of patients of unknown age and gender. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On an unknown date, the patients were vaccinated with improperly stored dose of VAQTA lot # M036459, expiry date: 18-JAN-2018 (dosing details were not reported). It was reported that the vaccines were exposed to a temperature of 0.7C during a time frame of 2 hours. No previous temperature excursion was reported. No adverse effects were reported. There were no product quality complaints (PQC) involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. Information about the patient's medical history, concurrent conditions and concomitant medication was not reported. On an unspecified date the patient was administered a dose of improperly stored GARDASIL (Lot #, expiration date, strength, dose, route of administration was not reported). The patient's physician office contacted the patient and stated that the patient would need to be revaccinated. No adverse event was reported. No product quality complaint was involved. 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 medical assistant referring to unspecified number of patients of unknown age and gender. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On an unknown date, the patients were vaccinated with improperly stored dose of ROTATEQ lot # M007298, expiry date: 19-NOV-2017 (dosing details were not reported). It was reported that the vaccines were exposed to a temperature of 0.7C during a time frame of 2 hours. No previous temperature excursion was reported. No adverse effects were reported. There were no product quality complaints (PQC) involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This report was received from a nurse referring to a 61 year old male patient. Patient's pertinent medical history, drugs reactions/allergies and concomitant medication were not reported. The reporter stated that on an unspecified date, a dose of ZOSTAVAX lot #: M035147 and expiration date: 25-OCT-2017, was exposed to a temperature excursion of 6F for 40 minutes. The reporter also stated that the patient was vaccinated with this improperly stored ZOSTAVAX (route, strength and dosage schedule were not reported. No adverse event was reported. No Product Quality Complaint (PQC) was involved. Additional information is not expected since the reporter denied authorization to contact.
Sex: M
Vaccine: VARZOS
Symptoms: Otitis externa
Clinical narrative: This spontaneous report was received from a consumer refers to himself, a male patient of unknown age. Medical history and concomitant medication not reported. The patient reported that "eight to ten year ago" he was vaccinated with ZOSTAVAX, Lot number not reported. The patient reported he experiences "swimmer's ear" intermittently. The outcome of swimmer's ear is unknown. Additional information is not expected.
Sex: U
Vaccine: PPV
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age. On an unknown date the patients were vaccinated with PNEUMOVAX 23. The certified medical assistant reported that an unspecified number of patients were administered PNEUMOVAX 23 vaccine eight weeks after being administered PREVNAR 13 vaccine regardless if they were immunocompromised, immunocompetent, had cerebrospinal fluid leak, or cochlear implants. "According to the CDC guidelines, there are different schedules for administration of PREVNAR 13 and PNEUMOVAX 23 for specific populations." The exact number of patients who have been administered the PNEUMOVAX 23 eight weeks after PREVNAR 13 could not be confirmed, but the certified medical assistant reported that more were scheduled to received PNEUMOVAX 23 in this manner. The outcome of the event was unknown. Additional information is not expected.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site reaction
Clinical narrative: This spontaneous report was received from a pharmacist via company representative refers to a 63 year old female patient. No medical history, concurrent conditions and concomitant medications were reported. On MAY-2014, the patient was vaccinated with a dose of ZOSTAVAX, intramuscular. On MAY-2014, the patient developed injection site reactions a day after receiving ZOSTAVAX. Injection site reactions included itchiness and redness. Treatment was rendered for the event. No lab tests were performed. The outcome of the events were reported as recovered/resolved. The patient sought medical attention. Additional information has been requested.