chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse regarding an unspecified number of patients of unknown demographics. There was no information about concurrent condition and historical medication. On 13-SEP-2016, the patients were vaccinated with improperly stored VARIVAX lot # I048465/ expiration date- 02-DEC-2017. No adverse event was reported. No concomitant medication was reported. The outcome of the event was unknown. NO PQC (product quality complaint) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse regarding an unspecified number of patients of unknown demographics. There was no information about concurrent condition and historical medication. On 13-SEP-2016, the patients were vaccinated with improperly stored ZOSTAVAX lot # L036823/ expiration date-24--DEC-2016. No adverse event was reported. No concomitant medication was reported. The outcome of the event was unknown. No PQC (product quality complaint) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to a patient of unknown age and gender. The patient's pertinent medical history, allergic reactions and concomitant medications were unspecified. On an unknown date, the patient was vaccinated with improperly stored GARDASIL 9 (lot # L014415, expiry date 25-JUL-2017, dose, strength, dose number, vaccination site, route not provided). No adverse effects were reported. Product quality complain (PQC) was not involved. No further information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, Chills, Headache, Nausea, Urticaria
Clinical narrative: Chills, Nausea, weakness, Headache the day after vaccination. Urticarial rash began 96 hours after vaccination, (and has not yet resolved).
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Blister, Pruritus, Rash
Clinical narrative: Begin itching on arms/legs/torso. Bumps like/size of chickenpox with small blister heads appeared. Severe itching so took BENADRYL and used cortisone cream. Bumps spread over torso, back of arms, armpits, tools of legs, behind knees. Bumps still itchy and very visible as of 9/17/2016. No fever. No malaise. No headache or other symptoms.  Bumps do not scab over nor do blisters break and spread. Largest bump about width of frozen green pea.
Age: 24.0
Sex: M
Vaccine: ANTH
Symptoms: Immediate post-injection reaction, Mass, Pruritus, Rash erythematous, Skin warm
Clinical narrative: Immediately following the vaccines and every 3-4 weeks continuously since then, for the past 9 years, I get a red rash and a hard lump in 2 spots on my right arm where the vaccine was administered. It is hot to the touch, itches, it looks like a raised welt. It surfaces and dissipates at random.
Age: 24.0
Sex: M
Vaccine: ANTH
Symptoms: Urticaria
Clinical narrative: Immediately following the vaccines and every 3-4 weeks continuously since then, for the past 9 years, I get a red rash and a hard lump in 2 spots on my right arm where the vaccine was administered. It is hot to the touch, itches, it looks like a raised welt. It surfaces and dissipates at random.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Crying, Decreased appetite, Pyrexia, Restlessness
Clinical narrative: High fever in the morning, followed with a decrease of appetite. That went on for 3 days. Then the fever went down and his appetite still was not very good. He won't take naps like usual and at night he is very restless. Tosses and turns and one night was crying unconsolable. I have also noticed that since the MMR shot his walking that he was getting so good at took a step back and he wasn't walking as well.
Age: 38.0
Sex: F
Vaccine: HEP
Symptoms: Arthralgia, Lethargy, Lymphadenopathy, Migraine, Nausea
Clinical narrative: Swollen lymph nodes, swollen tonsils, high fever over 100°, lethargy, joint pain, migraine headache. Sore throat. Nausea.
Age: 38.0
Sex: F
Vaccine: HEP
Symptoms: Oropharyngeal pain, Pyrexia, Tonsillar hypertrophy
Clinical narrative: Swollen lymph nodes, swollen tonsils, high fever over 100°, lethargy, joint pain, migraine headache. Sore throat. Nausea.
Age: 56.0
Sex: M
Vaccine: FLUC4, PPV
Symptoms: Dyspnoea, Peripheral swelling, Swelling
Clinical narrative: Patient presented at the pharmacy on Saturday at approximately 12:30PM complaining that the night before, his arm left was swollen as well as his chest on the same side and had has some difficulty breathing. He said at that moment his breathing was better but he was still swollen. Patient was give two 25mg oral diphenhydramine caps and sat on the bench in front of the pharmacy until his wife was done shopping and then left with her. I called patient at 5:00PM Saturday. He said his breathing was better but he was still swollen. I advised him to seek medical attention if the swelling did not go down.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Hot, red area around immunization site about 3" in diameter.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Left deltoid red and a little swollen. Itches.  Patient will use benadryl and ice compress.
Age: 73.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Pain
Clinical narrative: Sore, redness approx. 3 inch/dia,  still quiet large on 09/18/2016.
Age: 62.0
Sex: F
Vaccine: FLU4, VARCEL
Symptoms: Erythema, Mass, Paraesthesia, Pruritus, Skin warm
Clinical narrative: Immediately after injection of the shingles vaccine in left arm, my left hand got pins and needles in it as if it were asleep. This lasted only until I walked out of the store and to my car. A Red Raised Warm Welt appeared about 2" x 2" in size along with a marble sized lump. Perfectly Normal according to papers I received. However, by 48 HRS later, this Red Raised Warm Welt grew to be 3" wide x 4" long and the lump grew to be golf ball size. I put my Nicoderm Patch on the other arm and I Went back to the Pharmacist who advised me to use Maximum Strength anti-itch ointment (1% hydrocortisone). That evening, the lump grew to Baseball size but the ointment was working on the itching. Each day it seems to be a lighter shade of red and today's date, the lump is returned to marble size.
Age: 62.0
Sex: F
Vaccine: FLU4, VARCEL
Symptoms: Urticaria
Clinical narrative: Immediately after injection of the shingles vaccine in left arm, my left hand got pins and needles in it as if it were asleep. This lasted only until I walked out of the store and to my car. A Red Raised Warm Welt appeared about 2" x 2" in size along with a marble sized lump. Perfectly Normal according to papers I received. However, by 48 HRS later, this Red Raised Warm Welt grew to be 3" wide x 4" long and the lump grew to be golf ball size. I put my Nicoderm Patch on the other arm and I Went back to the Pharmacist who advised me to use Maximum Strength anti-itch ointment (1% hydrocortisone). That evening, the lump grew to Baseball size but the ointment was working on the itching. Each day it seems to be a lighter shade of red and today's date, the lump is returned to marble size.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Retching
Clinical narrative: Patient was given two immunizations in the same arm 1-2 inches apart. Patient was given PNEUMOVAX 23 and FLUZONE HD. The patient presented to the pharmacy the next day with redness, swelling, tenderness to the area, and reported 'dry heaves'. Patient self admitted to ER for observation the evening of 9/12/16.
Age: 43.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Fatigue, Headache, Hepatic enzyme, Hypersensitivity, Lacrimation increased
Clinical narrative: Extreme fatigue onset, felt heavy limbed and sore throat. The next morning, had allergic reaction - head congestion, eyes streaming, violent headache. 9/14 in am, had stiff, painful neck and migraine, photosensitivity that lasted for 3 days.
Age: 43.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Limb discomfort, Migraine, Musculoskeletal stiffness, Neck pain, Oropharyngeal pain
Clinical narrative: Extreme fatigue onset, felt heavy limbed and sore throat. The next morning, had allergic reaction - head congestion, eyes streaming, violent headache. 9/14 in am, had stiff, painful neck and migraine, photosensitivity that lasted for 3 days.
Age: 43.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Pancreatic enzymes, Photosensitivity reaction, Streptococcus test negative, Upper respiratory tract congestion
Clinical narrative: Extreme fatigue onset, felt heavy limbed and sore throat. The next morning, had allergic reaction - head congestion, eyes streaming, violent headache. 9/14 in am, had stiff, painful neck and migraine, photosensitivity that lasted for 3 days.
Age: 43.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Pancreatic enzymes, Photosensitivity reaction, Respiratory tract congestion, Streptococcus test negative, Throat tightness
Clinical narrative: Extreme fatigue onset, felt heavy limbed and sore throat. The next morning, had allergic reaction - head congestion, eyes streaming, violent headache. 9/14 in am, had stiff, painful neck and migraine, photosensitivity that lasted for 3 days.
Age: 74.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Arm is swollen, red, and hot.
Age: 18.0
Sex: M
Vaccine: HPV9, MENB
Symptoms: Fatigue, Injected limb mobility decreased, Injection site erythema, Injection site swelling, Pain in extremity
Clinical narrative: Both arms sore and unable to move them. General fatigue. Swelling and redness at both sites.
Age: 27.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site swelling, Pyrexia, Vaccination site erythema
Clinical narrative: Swollen upper left arm, ruddiness in area of vaccination, low grade fever.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Nausea, Vomiting
Clinical narrative: See previous explanation of events and symptoms.
Age: 58.0
Sex: F
Vaccine: FLUC4
Symptoms: Abdominal pain, Hypotension, Nausea, Syncope
Clinical narrative: Severe, sharp abdominal pain, nausea, fainting, extreme low blood pressure.
Age: 74.0
Sex: M
Vaccine: PNC13
Symptoms: Mobility decreased, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Right arm began to stiffen up. By 9PM I was unable to raise above about 30 degrees. Became quite sore. Put on ice packs and took ALEVE but stiffness has not gone away although pain is less as of 3PM on Sept 18. Will contact doctor tomorrow morning (Monday).
Age: 80.0
Sex: M
Vaccine: UNK
Symptoms: Blood test normal, Decreased appetite, Fatigue, Pain, Weight decreased
Clinical narrative: Achy, fatigue, loss of appetite, loss of weight, I've lost 20 pounds since.
Age: 26.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Pain, Skin warm, Swelling
Clinical narrative: Swelling, hot to touch, pain and redness, tried benadryl and clartin, and ice; no help.
Age: 27.0
Sex: M
Vaccine: HEP, TYP
Symptoms: Incorrect product storage
Clinical narrative: Vaccines were kept in ACUTEMP cooler for 4 hours. For the first 2 hours, the hourly temperatures weren't recorded, but in the last 2 hours, the temps were recorded every hour and in normal range.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Body temperature increased, Chest discomfort, Nasal congestion
Clinical narrative: Elevated temperature of 100.4 degrees. Some chest discomfort and nasal congestion. Took aspirin or acetaminophen until temperature returned to normal (approximately 36 hours later).
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain, Lethargy, Myalgia, Pyrexia
Clinical narrative: Pain in injected arm, fever, muscle soreness & lethargy.
Age: 74.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site pain, Urticaria
Clinical narrative: Patient reports hives on injected arm tenderness in the area and a linear redness on inside of arm but reports no redness at sites of injections. Patient reported this to me approximately 2 days after receiving vaccinations. Patient stated taking BENADRYL which I agreed that she can continue to take to control the hives after consulting immunize.org and reviewing package insert with her on PPSV23 going over reported side effects of medication. Patient received 2 vaccinations in same arm greater than 1 inch apart PPSV23 and HD FLUZONE.
Age: 61.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Cellulitis, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Swollen, red, and hot to the touch at the injection site.
Age: 65.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Muscular weakness, Pain in extremity, Pruritus generalised
Clinical narrative: Patient returned to pharmacy complaining that she was itchy all over. Gave 25mg liquid BENADRYL. Took BP 130/76. Sat with patient and explained symptoms of anaphylaxis. Advised ER for observation. Itching decreased. Pt left with spouse and promised to stay in town near hospital for at least an hour. Called pt at home at 3:15 pm and itch was gone complained of sore arm and tired legs but said was fine otherwise.
Age: 65.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Patient returned to the pharmacy on 9/16/2016 and showed me her arm. Her arm was swollen, red, and warm to the touch. I advised her to go see her doctor and she then returned later on in the day with a prescription for an antibiotic.
Age: 38.0
Sex: F
Vaccine: FLUR3
Symptoms: Injection site pain, Injection site rash, Injection site swelling, Urticaria
Clinical narrative: HIVES, RASH AROUND INJECTION SITE WITH SEVERE PAIN AND SWELLING.
Age: 65.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Arthralgia, Constipation, Fatigue, Injected limb mobility decreased, Injection site pain
Clinical narrative: At 6:15 PM soreness at the site, nausea, aching joints, headache: thought nothing of it and went to bed. 09/17/2016: AM all of the above plus fatigue. PM Swelling at the site, blotchy redness about 2.5" diameter, painful to touch, could not raise arm above shoulder, mild sore throat started, constipation (unusual for this patient), fever (3.5 degrees above patient's normal temperature) NB no signs of allergic reaction. Went online and decided symptoms were at the outer edge of normal. Took 400mg. ibuprofen. 09/18/2016 fever down 1.5 degrees, pain and achiness ongoing, fatigue extreme, nausea ongoing. Spent most of the day in bed. Decided to report my experience. I have never before had a bad reaction to a vaccine, and I've had a lot of them.
Age: 65.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site swelling, Nausea, Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: At 6:15 PM soreness at the site, nausea, aching joints, headache: thought nothing of it and went to bed. 09/17/2016: AM all of the above plus fatigue. PM Swelling at the site, blotchy redness about 2.5" diameter, painful to touch, could not raise arm above shoulder, mild sore throat started, constipation (unusual for this patient), fever (3.5 degrees above patient's normal temperature) NB no signs of allergic reaction. Went online and decided symptoms were at the outer edge of normal. Took 400mg. ibuprofen. 09/18/2016 fever down 1.5 degrees, pain and achiness ongoing, fatigue extreme, nausea ongoing. Spent most of the day in bed. Decided to report my experience. I have never before had a bad reaction to a vaccine, and I've had a lot of them.
Age: 65.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Rash macular, Tenderness
Clinical narrative: At 6:15 PM soreness at the site, nausea, aching joints, headache: thought nothing of it and went to bed. 09/17/2016: AM all of the above plus fatigue. PM Swelling at the site, blotchy redness about 2.5" diameter, painful to touch, could not raise arm above shoulder, mild sore throat started, constipation (unusual for this patient), fever (3.5 degrees above patient's normal temperature) NB no signs of allergic reaction. Went online and decided symptoms were at the outer edge of normal. Took 400mg. ibuprofen. 09/18/2016 fever down 1.5 degrees, pain and achiness ongoing, fatigue extreme, nausea ongoing. Spent most of the day in bed. Decided to report my experience. I have never before had a bad reaction to a vaccine, and I've had a lot of them.
Age: 75.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Slight redness, swelling and itching around the injection site.
Age: 3.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Dysphemia
Clinical narrative: Stuttering. He never stuttered at all. He loved to talk and talked clearly. Now he stutters over every word he says and doesn't want to talk anymore.
Age: 36.0
Sex: F
Vaccine: PPV
Symptoms: Rash erythematous, Rash macular, Rash pruritic
Clinical narrative: Small red blotch turned into huge hot red itchy rash like area the size of a softball. By the 3rd day after vaccine, it was the size of a melon, spreading up/down and side to side of upper arm. VERY PAINFUL.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, Muscle spasms
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 70 year old male patient. The patient had no pertinent medical history and concomitant medications. On 13-SEP-2016, the patient was inadvertently vaccinated with ZOSTAVAX lot # L036823 intramuscularly into the deltoid muscle. On 13-SEP-2016, the patient deltoid muscle had a muscle spasm. On 13-SEP-2016, the muscle spasm resolved in an unspecified amount of time with no medical intervention of treatment. No lab tests had been performed. The reporter did not provide the causality between the event and the suspect therapy. Additional information has been requested.
Age: 61.0
Sex: M
Vaccine: UNK
Symptoms: Chills, Hyperhidrosis, Malaise
Clinical narrative: Patient received vaccine mid-morning (around 10:30 am). By 4pm that day, he began to feel ill. The next morning, he experienced chills, sweating and general malaise. By the morning after that, he had no remaining symptoms.
Age: 52.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Condition aggravated, Dermatitis contact, Injection site rash, Injection site scab
Clinical narrative: Rash at site of injection (right arm). In addition to a small rash and scab where band aid was attached to skin. Pt has allergy to adhesive but insisted on band aid use.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Nodule
Clinical narrative: Patient had some bruising and a small nodule (bump) size of 1/2 of pen size. There was no paint and it wasn't red. Patient felt well and didn't have a fever/malaise.
Age: 7.0
Sex: M
Vaccine: FLU4
Symptoms: Cellulitis, Culture wound, Induration, Tenderness
Clinical narrative: Patient received flu-vaccine on 9/16/16. Presented to urgent care on 9/18/16 with bullous cellulitis with tender induration, 3cmx5cm.
Age: 71.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Headache, Injection site swelling, Pyrexia, Vertigo, Vomiting
Clinical narrative: 24-48 hours after injection, patient had symptoms of vomiting, headache, vertigo, and fever of 102. He could not keep food down and drank only water. Patient had minor swelling at injection site.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Redness on right arm around the injection site, felt a little warm 10cm x 10cm area of redness and induration around Rt deltoid and 5cm x 3cm pinkness no induration left deltoid.
Age: 81.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Induration, Injection site streaking, Local swelling, Skin warm
Clinical narrative: Redness, swollen, hot to the touch, hardness of area, approx. 3 inch diameter, purple streak injection site.
Age: 77.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness swelling heat at Bicep Brachii inside of arm above elbow - down and inside of arm not at injection site only on the PNEUMOVAX arm.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Extremely sore at the site of injection and is mildly sore to date. Soreness has not completely gone away.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Pain in extremity, Pyrexia, Skin discolouration
Clinical narrative: 2 inch diameter black bruise with 1/2 inch additional radius that was light green/blue around; sore arm which occurred mid-afternoon the day after administration; fever the night of.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to multiple patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. On unknown dates, the patients' were vaccinated with improperly stored VARIVAX subcutaneously (dose unknown) from lot # M015735 with an expiry date of 30-MAR-2018. No adverse effects were reported. Therapy with VARIVAX was continued. No product quality complaint was involved. This is one of the two reports received 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 as received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. The reporter stated that, starting on or after 30-AUG-2016, patients' were vaccinated with improperly stored VARIVAX (dose and route unknown) from lot # M000757 with expiry date of 06-JAN-2018. The vaccines were exposed to a temperature excursion of 10.4 F for a time frame of 2 hours. Digital data logger was involved. No adverse effects were reported. No product quality complaint was involved. This is one of the two reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Exposure during pregnancy, Herpes zoster, Injection site erythema, Injection site pruritus, Injury associated with device
Clinical narrative: This spontaneous prospective pregnancy report was received from a pharmacist who is also the female patient of unknown age regarding herself. Medical history, drug allergies and concomitant medications were unknown. On an unknown date in 2016, the patient had inadvertently injected herself with ZOSTAVAX and developed "Shingles". The patient was currently pregnant and when she was finished injecting the sterile water diluent into the via of the ZOSTAVAX she pulled out the syringe to attach another needle and inadvertently stuck the needle in her finger "before she drew up the reconstituted dose of ZOSTAVAX" on an unspecified date approximately in 2016. The primary reporter stated that "two days later" on an unspecified date approximately in 2016 her finger became extremely "itchy, red and swollen" at the site where the needle inadvertently penetrated her skin. The LMP and EDD was not known. The pregnancy outcome was pending. No laboratory tests were performed. The patient stated that she did not seek treatment, and was presently not recovered. The outcome of shingles was unknown. The causality was not reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Puncture site swelling
Clinical narrative: This spontaneous prospective pregnancy report was received from a pharmacist who is also the female patient of unknown age regarding herself. Medical history, drug allergies and concomitant medications were unknown. On an unknown date in 2016, the patient had inadvertently injected herself with ZOSTAVAX and developed "Shingles". The patient was currently pregnant and when she was finished injecting the sterile water diluent into the via of the ZOSTAVAX she pulled out the syringe to attach another needle and inadvertently stuck the needle in her finger "before she drew up the reconstituted dose of ZOSTAVAX" on an unspecified date approximately in 2016. The primary reporter stated that "two days later" on an unspecified date approximately in 2016 her finger became extremely "itchy, red and swollen" at the site where the needle inadvertently penetrated her skin. The LMP and EDD was not known. The pregnancy outcome was pending. No laboratory tests were performed. The patient stated that she did not seek treatment, and was presently not recovered. The outcome of shingles was unknown. The causality was not reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On an unknown date in 2016, the patient was inadvertently vaccinated with expired M-M-R II, lot # M001200, expiry date 28-AUG-2016, 1 dose, subcutaneously. No adverse effects were reported. Therapy with M-M-R II was continued. The outcome of the events was unknown. No product quality complaint (PQC) was involved. No further information was provided. Additional information has been requested.
Sex: F
Vaccine: HPVX
Symptoms: Muscle twitching
Clinical narrative: This spontaneous report was received from a medical assistant via company representative regarding a female patient of unknown demographics. Information on pertinent medical history, drug reactions/allergies and concomitant medications were not reported. The medical assistant reported that her cousin after receiving GARDASIL or GARDASIL 9 (medical assistant could not confirm if it was GARDASIL or GARDASIL 9) dose developed facial twitches. It was unknown if the patient had completed GARDASIL or GARDASIL 9 series. No product quality complaint (PQC) was involved. Outcome and causality of the event was not reported. Additional information is not expected as there is no consent to contact the reporter.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to unspecified patients of unknown age and gender. Information regarding patients' medical history, concurrent condition, drug reactions/allergies and concomitant therapy were not provided. On unspecified dates between 11-SEP-2016 and 14-SEP-2016, the patients were vaccinated with unspecified doses of improperly stored RECOMBIVAX HB (lot # M013639, expiry date: 15-SEP-2017; lot # I042846, expiry date: 15-SEP-2017 and lot # I010595, expiry date: 12-NOV-2016). No adverse reactions were reported. This is one of the five reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse regarding unspecified patients of unknown age and gender. Information regarding the pertinent medical histories, drug reactions or allergies and concomitant therapies were not provided. On unspecified dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 injection (lot # M011840, Expiration date 01-FEB-2018; lot # L037554, Expiration date 25-DEC-2017; lot # L026602, Expiration date 19-OCT-2017; lot # L024993, Expiration date 17-OCT-2017) (dosing details not known). The administered doses experienced a temperature excursion of 49.7 degree Fahrenheit for 8 hours. The call was because of a data logger. There was no previous temperature excursions. No adverse effects reported. This is one of the two 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 was received from a medical assistant refers to unspecified patients of unknown age and gender. Information regarding patients' medical history, concurrent condition, drug reactions/allergies and concomitant therapy were not provided. On unspecified dates between 11-SEP-2016 and 14-SEP-2016, the patients were vaccinated with unspecified doses of improperly stored VAQTA (lot # L036878, expiry date: 26-MAY-2017; lot # 0097876, expiry date: 26-MAY-2017; lot # L015468, expiry date: 20-JUL-2017). No adverse reactions were reported. This is one of the five 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 was received from a medical assistant regarding multiple unspecified patients of unknown age and gender. On 21-JUL-2016, 04-AUG-2016 and 17-AUG-2016, the multiple unspecified patients were vaccinated with improperly stored doses of ROTATEQ (lot # L048854, expiry:31-AUG-2017) orally. No adverse effects were reported. The vaccines underwent temperature excursion on 18-JUL-2106 at 48.37 degree F for 48 hours, on 19-AUG-2016 at 34.16 Degree F for 24 hours and on 22-AUG-2016 at 53.16 degree F for 48 hours. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a pharmacy technician referring to multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant therapy were not reported. On unknown dates, the patients received improperly stored VARIVAX (lot # L037559, expiration date 29-SEP-2017; lot # M000757, expiration date 06-JAN-2018, dose and route were unknown). No adverse effects were reported. 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 was received from a registered nurse regarding unspecified patients of unknown age and gender. Information regarding the pertinent medical histories, drug reactions or allergies and concomitant therapies were not provided. On unspecified dates, the patients were vaccinated with improperly stored doses ROTATEQ (lot # L048854, Expiration date 31-AUG-2017; batch L035637, Expiration date 09-JUN-2017; lot # M019708, Expiration date 25-OCT-2017) (dosing details not know). The administered doses experienced a temperature excursion of 49.7 degree Fahrenheit for 8 hours. The call was because of a data logger. There was no previous temperature excursions. No adverse effects reported. This is one of the 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 healthcare professional regarding unspecified number of patients of unknown age and gender. On an unknown date the patients received improperly stored doses of PROQUAD (lot# M017334 expiry: 05-OCT-2017) (data digital logger). No adverse effects were reported. The vaccines were exposed to a temperature of 5.4 degree C for 3 hours and 53 minutes. There was no previous exposure reported. This is 1 of 2 reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Erythema, Pain in extremity
Clinical narrative: This spontaneous report was received from a nurse refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date (also reported as several months ago), the patient was vaccinated with dose of PNEUMOVAX 23, lot # M006139, expiry date 13-MAY-2017, intramuscularly, (dose and frequency not reported). On an unknown date, the patient developed redness and pain on arm. Reporter did not recall any further details about the event "since it was so many months ago". The outcome of the events was unknown. Causality assessment was not provided. No product quality complaint (PQC) was involved. No further information provided. This is one of three 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 nurse, refers to an unknown amount of patients of unknown age and gender. Pertinent medical history, drug reactions/allergies and concomitant medications were not reported. Nurse reported that improperly stored PROQUAD, lot # M007962, expiry date 15-AUG-2017, vaccines were administered to patients on unspecified dates after temperature excursion (temperature: 19.6 F, time range 1 hour and 30 minutes) on 13-JUL-2016. No adverse effects reported. The outcome of the events was unknown. No product quality complaint (PQC) was involved. 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: Information has been received from a pharmacy technician referring to multiple unspecified patients of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On unknown dates, the patients received improperly stored ROTATEQ (lot # L042214, expiration date 14-JUN-2017; lot # M019706, expiration date 24-OCT-2017, dose unknown) orally. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse, refers to an unknown amount of patients of unknown age and gender. Pertinent medical history, drug reactions/allergies and concomitant medications were not reported. Nurse reported that improperly stored VARIVAX, lot # L023587, expiry date 26-JUN-2017, 0.5 ml, vaccines were administered to patients on unspecified dates after temperature excursion (temperature: 19.6 F, time range 1 hour and 30 minutes) on 13-JUL-2016. No adverse effects reported. The outcome of the events was unknown. No product quality complaint (PQC) was involved. This is one of three reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse, refers to an unknown amount of patients of unknown age and gender. Pertinent medical history, drug reactions/allergies and concomitant medications were not reported. Nurse reported that improperly stored ZOSTAVAX, lot # L028279, expiry date 28-OCT-2016, vaccines were administered to patients on unspecified dates after temperature excursion (temperature: 19.6 F, time range 1 hour and 30 minutes) on 13-JUL-2016. No adverse effects reported. The outcome of the events was unknown. No product quality complaint (PQC) was involved. This is one of three reports received from the same reporter. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Erythema, Headache, Pain in extremity, Skin warm
Clinical narrative: Information has been received from a 61 year old female patient with no drug reactions or allergies concerning herself. The patient's concurrent conditions included high blood pressure and osteoporosis. Concomitant therapies included unspecified "Routine Medication". On 12-AUG-2016, the patient was vaccinated with ZOSTAVAX subcutaneous injection (lot #, expiration date, strength, dose and frequency were unknown), subcutaneously. On approximately 16-AUG-2016, about 4 days after receiving ZOSTAVAX, the patient experienced headache and hot, red spot. On 17-AUG-2016, 5 days after receiving ZOSTAVAX, the patient had severe back, leg and thigh pain. The patient did not seek medical attention, and no treatment was given for the events. No lab diagnostics studies were performed. At the time of reporting, the patient was recovering from the events. No product quality complaint (PQC) was involved. The causal relationship between the events and ZOSTAVAX was not provided. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant, refers to a 20 year old patient of unknown gender. The patient's pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On 01-SEP-2016, the patient was inadvertently vaccinated with a dose of PROQUAD, lot # L016394, expiry date 08-NOV-2016, subcutaneously. No adverse effect reported. The outcome of the events was unknown. No product quality complaint (PQC) was involved. No further details provided. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapy were not reported. On unknown dates, the patients were vaccinated with improperly stored VARIVAX (lot # M006729, expiration date 08-FEB-2018; lot # M017292, expiration date 07-APR-2018; lot # M010484, expiration date 01-MAR-2018, dose and route were not reported). No adverse symptoms were reported. This is one of several reports received from the same reportedr Additional information has been requested.
Age: 61.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 61 year old patient of unknown gender. On 06-SEP-2016, the patient was vaccinated with VARIVAX lot # L017144 due to human error for whom ZOSTAVAX was indicated. The patient had not reported an adverse experience. This case has been linked to case 1609USA006504 (same reporter link). Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant regarding unknown number of patients of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date the patients were vaccinated with improperly stored GARDASIL 9, .5 ml, lot no. L0044475/expiration date- 12-MAY-2017. No adverse event was reported. No concomitant medication was reported. The outcome of the event was unknown. No PQC (product quality complaint) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Vaccination error
Clinical narrative: This spontaneous report as received from a pharmacist refers to two unspecified infant patients of unknown age and gender. No historical and current conditions were reported. On an unknown date, the two infant patients was vaccinated with ZOSTAVAX in error. No adverse effects reported. No PQC involved. This case is linked to case 1609USA006501 (same reporter link). Additional information has been requested.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to multiple unspecified patients of unknown demography. On an unknown date, the patients were vaccinated with improperly stored VARIVAX and PROQUAD (Incorrect product storage). No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant regarding unknown number of patients of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date the patients were vaccinated with improperly stored ROTATEQ, lot# L038534/expiration date- 19-AUG-2017, lot# 035637/expiration date- 09-JUN-2018. No adverse event was reported. No concomitant medication was reported. The outcome of the event was unknown. No PQC (product quality complaint) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a male patient of unknown age. The patient pertinent medical history included hypertension and anxiety. On 11-SEP-2016, the patient was vaccinated with PNEUMOVAX 23 lot # L035687, intramuscular. Concomitant medications included unspecified medication for hypertension and anxiety. On 12-SEP-2016, 2 days after onset of therapy the patient experienced tenderness and swelling of his left arm at the injection site. On 13-SEP-2016, the patient developed rash extending from the injection site to the inside of his left arm. The patient sought medical attention and came to pharmacy. The pharmacist stated that the rash was not itchy and the patient had not required medical treatment at the time of this report. No laboratory tests were performed. The outcome of the events were reported as not recovered. The reporter did not provide the causality between the events and the suspect therapy. Additional information is not expected as the pharmacist did not want to be contacted.
Age: 38.0
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy, Injection site pain
Clinical narrative: This spontaneous prospective pregnancy report as received from a physician refers to a 38 year old female patient. The patient pertinent medical history included asthma. On 12-SEP-2016 the patient was inadvertently vaccinated with GARDASIL 9 lot # M007764 who was 29 weeks pregnant. Concomitant therapies included PULMICORT, fluticasone, albuterol and unspecified prenatal vitamins. The patient became pregnant with LMP of 22-FEB-2016 and EDD of 28-NOV-2016. Initial exposure to GARDASIL 9 was at 29 week(s) (Exposure during pregnancy). On 12-SEP-2016, 1 day after onset of therapy the patient experienced soreness at the injection site. The patient sought medical attention. The patient did not receive any treatment for the event. The outcome of soreness at injection site was unknown. The outcome of pregnancy was unknown. The reporter did not provide the causality between the event soreness at the injection site and the suspect therapy. 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 nurse and refers to multiple patient of unknown age and gender. The patients' concurrent  conditions, medical history and concomitant medications were not reported. On unknown dates, the patients' were vaccinated with improperly stored VARIVAX subcutaneously (dose unknown) from lot # M003439 with an expiry date of 19-JAN-2018. No adverse effects were reported. Therapy with VARIVAX was continued. No product quality complaint was involved. This is one of the two reports received from same reporter. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: MMR
Symptoms: Herpes zoster, Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report was received from a nurse via a company representative regarding a 65 year old female patient. The patient's concurrent conditions, medical history and concomitant medications were not reported. In approximately 2016 (reported as within last two weeks), the patient was vaccinated with M-M-R II dose 1 and dose 2 (dose, route, therapy type, lot # and expiry date unknown) within last two weeks. On 09-SEP-2016, the patient presented with shingles. 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: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse regarding a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 08-SEP-2016, the patient was inadvertently vaccinated with a dose of expired VARIVAX, subcutaneously from lot # K010337 with expiry date of 22-JUL-2016. No adverse effects were reported. No product quality complaint was involved. Additional information has been requested.
Age: 0.8
Sex: F
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse regarding a 10 month old female patient. On 02-MAR-2012, the patient was vaccinated with first dose of VAQTA at 10 months of age. No adverse effects were reported. Additional information is not expected as reported did not wish further contact.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare professional regarding unspecified number of patients of unknown age and gender. On an unknown dates the patients received improperly stored doses of VARIVAX (lot# M019643, expiry: 20-APR-2018 and lot# M009767, expiry: 23-FEB-2018) (data digital logger). No adverse effects were reported. The vaccines were exposed to a temperature of 5.4 degree C for 3 hours and 53 minutes. There was no previous exposure reported. This is 1 of 2 reports from the same reporter. Additional information has been requested.