chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: PPV
Symptoms: Death, Drug ineffective, Malaise, Pneumonia
Clinical narrative: This spontaneous report has been received from a physician via a company representative referring to a male patient of unknown age reported as "in his 80's or 90's". Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not reported. On an unknown dates "for five consecutive years", the patient was vaccinated with one dose of PNEUMOVAX 23 (strength, dose, route, anatomical location, lot # and expiration date were not provided) for prophylaxis. On an unknown dates "for five consecutive years", the patient was hospitalized for pneumonia and while he was still sick, received a dose of PNEUMOVAX 23 every time he was hospitalized. It was also mentioned, that the PNEUMOVAX 23 was ineffective in preventing pneumonia for the patient (drug ineffective). Subsequently, on an unknown date, the patient died from an unknown cause. It was not known if an autopsy was performed. At the reporting time, the outcome of pneumonia, drug ineffective and malaise were unknown. The causality assessment between therapy with PNEUMOVAX 23 and the events was not reported. Upon internal review, pneumonia was determined to be medically significant. This is one of two cases from the same reporter. Sender's Comments: US-009507513-1804USA004352: Reported Cause(s) of Death: Cause of death unknown.
Sex: F
Vaccine: MMR
Symptoms: Maternal exposure during breast feeding
Clinical narrative: Information has been received from a female patient of unknown age, referring on herself. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date in April 2018 (reported as "a week ago"), the patient was vaccinated with a dose of M-M-R II (lot number, expiration date, administration route and anatomical location were not reported) for prophylaxis. The patient stated that she was currently nursing her child. The outcome of breast feeding was unknown and the causality between the vaccination with M-M-R II and the event was not reported.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report was received from a registered nurse refers to a 62-year-old female patient. The patient's concurrent conditions, medical history, drug reactions and allergies were unknown. The patient's concomitant medication included ENBREL. On 07-APR-2018 the patient was vaccinated with ZOSTAVAX 19400 PFU (dose, units and frequency were unknown) (lot# and expiration date unknown), subcutaneous for shingles prevention at unspecified local pharmacy. On an unknown date in April 2018, the patient experienced soreness, tenderness, swelling, redness at the injection site. It was reported that on 09-APR-2018, the patient went to urgent care for an unspecified reason "not related to the vaccination" and patient was asking about the arm where she had been vaccinated as there was soreness, tenderness, swelling, redness at the injection site, "a little bigger than what might be expected". The reporter stated that the location of the injection seemed very far down the patient's arm much lower than deltoid. It was reported that no treatment was given for the events soreness, tenderness, swelling, redness at the injection site. Outcome of the events soreness, tenderness, swelling, redness at the injection site was not recovered. The casual relationship between events soreness, tenderness, swelling, redness at the injection site and ZOSTAVAX was not provided. There was no product quality complaint (PQC) reported.
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to an adolescent patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions, allergies and concomitant therapy were unknown. On an unknown date, it was reported that the patient was vaccinated with second dose of VAQTA (strength, units, lot and expiration date unknown) on "2 months after first dose of VAQTA. No adverse effects were reported. There was no product quality complaint (PQC) reported.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a physician via Pfizer regarding a female patient of unknown age. The patients' concurrent conditions, concomitant therapy and medical history were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX subcutaneously (strength, dose, frequency, lot # and expiry date were not reported) for prophylaxis. Other suspect therapies included XELJANZ 11 mg oral tablet extended release once a day. On an unknown date, the reporter stated that "problems-zoster without complications, back under axilla to the breast left T-2 dermatome (herpes zoster). The outcome of herpes zoster was unknown. The reporter's causality assessment was not provided.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Fall, Head injury
Clinical narrative: This spontaneous report as received from a nurse refers to a 11 year old female patient. The patient's historical drugs, medical history, concomitant therapies and concurrent conditions were unknown by the reporter. On 06-APR-2018, the patient was vaccinated with GARDASIL 9, intramuscular, to prevent human papillomavirus (HPV) (strength, dose, frequency, lot#, expiration date were not reported). On the same day, 15 minutes of receiving the dose, the patient felt dizzy, fell, and hit her head on the ground. It was unknown if the patient received any treatment or if diagnostic laboratories were performed. The patient recovered on the same day. The causality assessment between aforementioned events and GARDASIL 9 was not provided.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse refers to a patient of an unknown age and gender. The patient's relevant medical history, concurrent condition and concomitant medication were not reported. On 12-APR-2018, the patient was vaccinated with an expired dose of VAQTA injection 25/0.5 (unspecified units) lot # N012324 (expired date: 05-APR-2018), intramuscularly (dose not reported) for prophylaxis. No adverse effect reported. No product quality complaint (PQC) was involved.
Age: 26.0
Sex: F
Vaccine: HPV9
Symptoms: Myalgia, Suicidal ideation
Clinical narrative: Suicidal ideation, muscle ache in affected arm that lasted two months.
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site pruritus, Injection site reaction, Pruritus, Rash, Rash macular
Clinical narrative: PATIENT DESCRIBED AS ITCHY, SPLOTCHY RED AREAS COVERING BOTH ARMS DOWN TO ELBOWS, BACK AND NECK WITHIN 1 DAY OF INJECTION.  PATIENT SELF TREATED WITH BENADRYL AND HYDROCORTISONE CREAM...IT WOULD WORK AND HE WOULD STOP, THEN RASH WOULD REAPPEAR WITHIN A FEW DAYS. PATIENT JUST REACHED OUT TO THE PHARMACIST YESTERDAY (BEING A LITTLE OVER A MONTH POST INJECTION). CONTACTED PATIENT THIS MORNING FOR ADDITIONAL DETAILS AND TOLD HIM TO CONTACT HIS MD TODAY AND TO CALL US BACK.  PT HAD NOT CONTACTED MD PRIOR TO HIS CALL TO US.
Age: 5.0
Sex: M
Vaccine: DTAP, HEP, IPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pain
Clinical narrative: Parent reports L arm red, swollen, warm to the touch, redness from left shoulder down to patient's bicep. Patient is able to move his arm but complains of pain upon movement. Patient never presented with a fever, parent stated, "his arm was so swollen the bandaid was like embedded in his arm."  Parent reports she did give patient fever reducer for the pain and swelling but did not seem to help, PHN encouraged parent to go to ER or to PCP for follow-up care. Parent said she would go  to PCP with patient later today.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient complained after receiving vaccine that he had redness with swelling to the injection site with pain that goes down to almost his hand. He stated he was not able to use the arm and rated the pain a 10/10. He denies any fevers, shortness of breath, wheezing or joint pain. He has not had reactions to vaccines in the past. Rash, urticaria pruritus and decreased ROM.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Irritability, Pyrexia
Clinical narrative: Fever of 105.7 rectally and irritability approximately 8 hours after vaccines given.
Age: 47.0
Sex: M
Vaccine: FLU3
Symptoms: Cognitive disorder, Confusional state, Feeling abnormal, Headache, Impaired work ability
Clinical narrative: NOTE:  I'm not sure of the Influenza type of Vaccine. I had severe mental decline for a period of time that was extreme on the second day after the influenza shot. The first day afterwards was mild but on the second day, I had cognitive decline to the point that I was unable to do basic office work duties/ work due to extreme headache and brain fog and mental confusion. This lasted at least 8 hours.
Age: 47.0
Sex: M
Vaccine: FLU3
Symptoms: Mental disorder
Clinical narrative: NOTE:  I'm not sure of the Influenza type of Vaccine. I had severe mental decline for a period of time that was extreme on the second day after the influenza shot. The first day afterwards was mild but on the second day, I had cognitive decline to the point that I was unable to do basic office work duties/ work due to extreme headache and brain fog and mental confusion. This lasted at least 8 hours.
Age: 61.0
Sex: M
Vaccine: TTOX
Symptoms: Feeling cold, Influenza like illness, Pain in extremity, Tremor
Clinical narrative: About ten hours after the injection (8:00 am), I started feeling like I had a flu coming, by 7:30 pm I was shaking and felt really cold. I got under a blanket when I got home and drank some tea. I went to bed at 9:00 pm wearing a t shirt, sweat pants and got another blanket to put on the bed as I was so cold. By 1:00 the next day the symptoms were subsiding - I still have a pain in the arm from the shot.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Immediate post-injection reaction
Clinical narrative: The patient immediately reported a headache upon vaccination - before vaccination was even complete, before the needle was removed from her arm. The patient called on 04/16/18 to report that she has had a headache every day for 6 days since vaccination.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions, allergies and concomitant medications were not reported. On 04-APR-2018, the patient was vaccinated with improperly stored PROQUAD (dose, units and frequency not reported) (lot # N020616 and expiration date: 22-JAN-2019) subcutaneously, at a temperature of 28.2 Fahrenheit (F) for 4 hours 57 minutes. No adverse effects were reported. It was reported that there was no previous temperature excursion. Data logger was involved. No product quality complaint was involved.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. The patient concurrent conditions, medical history, drug reactions and allergies were not reported. Concomitant therapies included sterile diluent. On 05-APR-2018, the patient was vaccinated with VARIVAX (dose, units and frequency not reported) (lot# N030407 and expiration date: 30-OCT-2019) via intramuscular route. No adverse effects reported. No product complaint was involved. Lot number [N030407] has been verified to be a valid lot number for VARIVAX.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood test, Bronchitis, Herpes zoster, Plasma cell myeloma, Pruritus
Clinical narrative: This spontaneous report as received from a currently 62 year old female patient regarding herself. The patient's historical condition included shingles. The patient's concomitant medications were not reported. The patient had drug reactions/allergies to Penicillin. On 09-NOV-2010, the patient was vaccinated with a ZOSTAVAX, (anatomical location, dose, unit, frequency, expiration date and lot number not specified) injection for shingles prophylaxis. It was reported that the patient's doctor prescribed her ZOSTAVAX because of her age and in order to prevent future shingles outbreak due to a history of prior shingles. On 24-NOV-2010, 07-APR-2016, 29-APR-2016, and 25-APR-2017 the patient experienced shingles outbreaks and was still currently experiencing itching on the hip. On an unknown date the patient also experienced Myeloma (plasma cell myeloma) and Bronchitis. It was unclear if the Myeloma and Bronchitis were preexisting conditions or experienced after ZOSTAVAX was administered. The patient sought medical attention and visited the physician. On unknown date an unspecified blood test was done (details unspecified) (units and values unknown). It was reported that the patient was treated for the adverse events. The action taken with the therapy with ZOSTAVAX was unknown. The outcome of the events was reported as not recovered. The reporter did not assess the causality of the event with suspect therapy. A Product quality complaint was not involved. Upon internal review, the event myeloma were determined to be medically significant.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. Information on patient's pertinent medical history, concomitant medication and drug reactions/allergies were not reported. On 06-APR-2018, the patient was vaccinated with an expired dose of VAQTA injection (strength and dose were not provided) (lot # N012324, expiration date: 05-APR-2018) intramuscularly for prophylaxis. No adverse effects were reported. No further details was provided. There was no product quality complaint (PQC) reported.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Feeling hot, Malaise, Muscle spasms, Neck pain
Clinical narrative: A few hours after vaccine, extreme arm swelling, redness, heat. Patient also states her neck and body ached, she was fevered, and had cramps in her right leg. She stated she was too sick to get out of bed. She has been taking Ibuprofen and it has been helping and she says she is feeling better today (4-16-18). When I asked if her symptoms were improving she stated yes.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Peripheral swelling, Pyrexia
Clinical narrative: A few hours after vaccine, extreme arm swelling, redness, heat. Patient also states her neck and body ached, she was fevered, and had cramps in her right leg. She stated she was too sick to get out of bed. She has been taking Ibuprofen and it has been helping and she says she is feeling better today (4-16-18). When I asked if her symptoms were improving she stated yes.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Fatigue, Headache, Nausea
Clinical narrative: Headache, body aches, join pain, fever, chills, nausea from 3 AM until 3 PM. Extremely fatigued for 24 hours.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: Headache, body aches, join pain, fever, chills, nausea from 3 AM until 3 PM. Extremely fatigued for 24 hours.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site pruritus, Injection site rash
Clinical narrative: Rash at injection sight approximately 4cmX5cm, cortisone to site for itching, Benadryl Child strength.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Hypersomnia, Pyrexia
Clinical narrative: HEADACHE, LOW GRADE FEVER (100.1), VERY TIRED, SLEPT ALOT - LASTED ALL DAY OF 4/11/2018 - FELT BETTER THE NEXT DAY.
Age: 26.0
Sex: F
Vaccine: FLU4, PPV, TDAP, TYP
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Pyrexia, Tenderness
Clinical narrative: Patient presented to office with complaints of fever, redness, swelling, and pain of L arm starting on 04/10/2018. Fever lasting 48-72 hours and two quarter size red areas to L arm that was mildly tender which she reported had improved at the time of office visit. Patient was instructed to take Ibuprofen 800mg three times a day as needed along with applying ice to the area for 20 minutes as minutes.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Pain in extremity
Clinical narrative: THE PATIENT COMPLAINED ABOUT SORE ARM AND HEAD ACHE THAT LASTED FOR 2-3 DAYS AFTER GETTING THE SHOT.
Age: 60.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Injection site pain, Lymphadenopathy, Myalgia, Swelling
Clinical narrative: Patient reported adverse events starting day after vaccine administration: pain at the injection site, muscle pain, redness, swelling, and swollen lymph nodes. Adverse events have not fully subsided as of today.
Age: 60.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain, Injection site swelling, Lymphadenopathy, Myalgia
Clinical narrative: Patient reported adverse events starting day after vaccine administration: pain at the injection site, muscle pain, redness, swelling, and swollen lymph nodes. Adverse events have not fully subsided as of today.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus, Skin warm, Swelling
Clinical narrative: Patient had severe swelling about the size of a baseball, redness, warm to the touch, and severe itching. Patient treated with BENADRYL tablets and Cortisone cream.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Altered state of consciousness, Asthenia, Cough, Ear pain
Clinical narrative: It began on the evening of the shot with first my upper arm becoming sore, sorer as the hours passed and then into my left shoulder. I went to bed and tossed and turned beginning a short time later with body aches and upset stomach feeling like I was getting a bad flu. By 4 - 5 AM I just got up and tried to go downstairs but had to keep sitting down on the steps because I felt like I was going to pass out. I laid on the couch under a blanket the entire day with severe headaches, upset stomach and body aches. By evening I had to hide under blankets upstairs not to smell any cooking food. I was hoping it would pass quickly but by the next very early morning I got up once again and came down. My headache which settled now on the right side, right eye and ear hurt so bad I felt like I was going to stroke out. My eyelid corners were swollen. I called the pharmacy finally to see if I could at least take TYLENOL and she said she thought that would be okay. I needed something for the pain and she said Ibuprofen but I asked her "isn't that what causes adverse effects if you have the flu and wouldn't TYLENOL be better". She told me to report the effects to the CDC. So I decided on the TYLENOL but after 3 double doses correctly timed and no difference I decided to put an ice pack straight on my head, eye and ear and take Ibuprofen. The symptoms started easing up a bit as I continued the ibuprofen and slept with ice packs. I tried ginger ale and bouillon and then some chicken soup for the upset stomach. Day 4 was better with still some headache and stomach symptoms. My legs felt like extreme noodles. By Day 5 in the evening I felt like I had a bit of energy and proceeded to do a few things then quickly wore out. Day 6 I wasn't sure if I was getting sick again or if now it was going into a cold or what. I took some SUDAFED as my head felt congested but still didn't feel quite right. I do not have a cold as of yet but still feel like I could be coming down with one. Nothing other than coughing now and then, a little bit of swelling on the eyelid corners and sneezing have developed.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Eye pain, Eyelid oedema, Feeling abnormal, Headache, Influenza like illness
Clinical narrative: It began on the evening of the shot with first my upper arm becoming sore, sorer as the hours passed and then into my left shoulder. I went to bed and tossed and turned beginning a short time later with body aches and upset stomach feeling like I was getting a bad flu. By 4 - 5 AM I just got up and tried to go downstairs but had to keep sitting down on the steps because I felt like I was going to pass out. I laid on the couch under a blanket the entire day with severe headaches, upset stomach and body aches. By evening I had to hide under blankets upstairs not to smell any cooking food. I was hoping it would pass quickly but by the next very early morning I got up once again and came down. My headache which settled now on the right side, right eye and ear hurt so bad I felt like I was going to stroke out. My eyelid corners were swollen. I called the pharmacy finally to see if I could at least take TYLENOL and she said she thought that would be okay. I needed something for the pain and she said Ibuprofen but I asked her "isn't that what causes adverse effects if you have the flu and wouldn't TYLENOL be better". She told me to report the effects to the CDC. So I decided on the TYLENOL but after 3 double doses correctly timed and no difference I decided to put an ice pack straight on my head, eye and ear and take Ibuprofen. The symptoms started easing up a bit as I continued the ibuprofen and slept with ice packs. I tried ginger ale and bouillon and then some chicken soup for the upset stomach. Day 4 was better with still some headache and stomach symptoms. My legs felt like extreme noodles. By Day 5 in the evening I felt like I had a bit of energy and proceeded to do a few things then quickly wore out. Day 6 I wasn't sure if I was getting sick again or if now it was going into a cold or what. I took some SUDAFED as my head felt congested but still didn't feel quite right. I do not have a cold as of yet but still feel like I could be coming down with one. Nothing other than coughing now and then, a little bit of swelling on the eyelid corners and sneezing have developed.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Muscular weakness, Pain, Parosmia, Respiratory tract congestion
Clinical narrative: It began on the evening of the shot with first my upper arm becoming sore, sorer as the hours passed and then into my left shoulder. I went to bed and tossed and turned beginning a short time later with body aches and upset stomach feeling like I was getting a bad flu. By 4 - 5 AM I just got up and tried to go downstairs but had to keep sitting down on the steps because I felt like I was going to pass out. I laid on the couch under a blanket the entire day with severe headaches, upset stomach and body aches. By evening I had to hide under blankets upstairs not to smell any cooking food. I was hoping it would pass quickly but by the next very early morning I got up once again and came down. My headache which settled now on the right side, right eye and ear hurt so bad I felt like I was going to stroke out. My eyelid corners were swollen. I called the pharmacy finally to see if I could at least take TYLENOL and she said she thought that would be okay. I needed something for the pain and she said Ibuprofen but I asked her "isn't that what causes adverse effects if you have the flu and wouldn't TYLENOL be better". She told me to report the effects to the CDC. So I decided on the TYLENOL but after 3 double doses correctly timed and no difference I decided to put an ice pack straight on my head, eye and ear and take Ibuprofen. The symptoms started easing up a bit as I continued the ibuprofen and slept with ice packs. I tried ginger ale and bouillon and then some chicken soup for the upset stomach. Day 4 was better with still some headache and stomach symptoms. My legs felt like extreme noodles. By Day 5 in the evening I felt like I had a bit of energy and proceeded to do a few things then quickly wore out. Day 6 I wasn't sure if I was getting sick again or if now it was going into a cold or what. I took some SUDAFED as my head felt congested but still didn't feel quite right. I do not have a cold as of yet but still feel like I could be coming down with one. Nothing other than coughing now and then, a little bit of swelling on the eyelid corners and sneezing have developed.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Restlessness, Sneezing
Clinical narrative: It began on the evening of the shot with first my upper arm becoming sore, sorer as the hours passed and then into my left shoulder. I went to bed and tossed and turned beginning a short time later with body aches and upset stomach feeling like I was getting a bad flu. By 4 - 5 AM I just got up and tried to go downstairs but had to keep sitting down on the steps because I felt like I was going to pass out. I laid on the couch under a blanket the entire day with severe headaches, upset stomach and body aches. By evening I had to hide under blankets upstairs not to smell any cooking food. I was hoping it would pass quickly but by the next very early morning I got up once again and came down. My headache which settled now on the right side, right eye and ear hurt so bad I felt like I was going to stroke out. My eyelid corners were swollen. I called the pharmacy finally to see if I could at least take TYLENOL and she said she thought that would be okay. I needed something for the pain and she said Ibuprofen but I asked her "isn't that what causes adverse effects if you have the flu and wouldn't TYLENOL be better". She told me to report the effects to the CDC. So I decided on the TYLENOL but after 3 double doses correctly timed and no difference I decided to put an ice pack straight on my head, eye and ear and take Ibuprofen. The symptoms started easing up a bit as I continued the ibuprofen and slept with ice packs. I tried ginger ale and bouillon and then some chicken soup for the upset stomach. Day 4 was better with still some headache and stomach symptoms. My legs felt like extreme noodles. By Day 5 in the evening I felt like I had a bit of energy and proceeded to do a few things then quickly wore out. Day 6 I wasn't sure if I was getting sick again or if now it was going into a cold or what. I took some SUDAFED as my head felt congested but still didn't feel quite right. I do not have a cold as of yet but still feel like I could be coming down with one. Nothing other than coughing now and then, a little bit of swelling on the eyelid corners and sneezing have developed.
Sex: F
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered pharmacist refers to a female patient of unknown age. No information about the patient's medical history, concurrent conditions and concomitant medications was reported. On 19-MAR-2018, the patient was vaccinated with a dose of expired VARIVAX lot # L044524, expiry date: 09-NOV-2017, 0.5 ml, subcutaneously. Concomitant therapy included sterile diluent. No adverse effects were reported.
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to a male patient who is currently 4 years old. Information regarding patient's medical history, concurrent conditions, concomitant medications, drug reactions, allergies and past therapies were not reported. On an unspecified dates, the patient was vaccinated with two doses of improperly stored PROQUAD lot # N015623, expiry date: 15-NOV-2018, lot #N024564, expiry date: 06-MAR-2019 for prophylaxis whose dose and route of administration were not reported. It was reported that vaccine was reconstituted with the sterile diluent (MERCK) lot # L030305, Expiry date: 08-APR-2018 also reported as "30-APR-2018" which was stored in proper conditions. The PROQUAD was subjected to a temperature excursion of 6 degree F to 14 degree F (5.9 degree F) for a time frame of 18 minutes which was noted from a data logger. There were no previous temperature excursions. No adverse effect reported. There was no product quality complaint (PQC) involved. This is one of the two reports received from the same reporter. Sender's Comments: US-009507513-1804USA002069.
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to a female patient who is currently 4 years old. Information regarding patient's medical history, concurrent conditions, concomitant medications, drug reactions, allergies and past therapies were not reported. On an unspecified dates, the patient was vaccinated with two doses of improperly PROQUAD lot # N015623, expiry date: 15-NOV-2018, lot #N024564, expiry date: 06-MAR-2019 for prophylaxis whose dose and route of administration were not reported. It was reported that vaccine was reconstituted with the sterile diluent (MERCK) lot # L030305, Expiry date: 08-APR-2018 also reported as "30-APR-2018" was stored in proper conditions. The PROQUAD was subjected to a temperature excursion of 6 degree F to 14 degree F (5.9 degree F) for a time frame of 18 minutes which was noted from a data logger. There were no previous temperature excursions. No adverse effect reported. There was no product quality complaint (PQC) involved. This is one of the two reports received from the same reporter. Sender's Comments: US-009507513-1804USA001618.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Face injury, Fall, Lumbar puncture, Myelitis transverse, Wheelchair user
Clinical narrative: This spontaneous report was received from a 68-year-old male patient who was referring to himself. The patient's medical history included back surgery. His concurrent conditions included reaction/allergy to codeine. He had no concomitant medications. On 06-DEC-2013, the patient was vaccinated with PNEUMOVAX23 (dose, site and route of administration, lot number and expiration date were not reported) as routine vaccination. On 09-DEC-2013, reported as 3 days after the vaccination, he experienced myelitis transverse described as "falling on his face". On an unknown date, the patient sought medical attention by going to an emergency room and he was hospitalized. He had a spinal taps performed (no results were provided) and an unspecified treatment was administered. He needed a wheelchair in 2014. The outcome of the event and the causality between the event and PNEUMOVAX23 were not reported. Upon internal review, the event of myelitis transverse was determined to be medically significant and disabling.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a pharmacist concerning a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 09-APR-2018, the patient was vaccinated with an improperly stored dose of ZOSTAVAX 19400 PFU, lot # N003697 and expiration date on 13-MAR-2018, for prophylaxis. The vaccine was reconstituted with a properly stored sterile diluent (MERCK). There was no adverse effect reported. No product quality complaint was involved.
Sex: M
Vaccine: HPV9
Symptoms: Seizure, Tremor
Clinical narrative: This spontaneous report as received from a physician via a field representative refers to a pediatric male patient of unknown age. The patient concurrent condition, medical history, drug reactions/allergies and concomitant condition were not reported. On an unknown date in April 2018 the patient was vaccinated with GARDASIL 9 (dose, frequency, lot #, expiry date and route were not reported) for prophylaxis. On an unknown date in April 2018 the patient had an unspecified seizure that included unspecified tremors in the car, on the way home after administration of GARDASIL 9. The physician also reported the patient returned to the office after the seizure on the same unspecified date. The outcome of the event seizure was reported as recovered. The relatedness of the events to seizure to the therapy with GARDASIL 9 was unknown. No product quality complaint was involved. Upon internal review, the event seizure was determined to be medically significant.
Sex: U
Vaccine: PPV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a office administrator refers to a 2 month old patient. On an unknown date, the 2 month old patient was vaccinated with one dose of PNEUMOVAX 23 from lot N023651 expiry date 20-MAY-2019 for prophylaxis. No adverse effect reported. No product quality complaint involved.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information was received from an attorney regarding a case in litigation concerning a female patient of unknown age. Medical history, concurrent conditions and concomitant medications were not provided. In or about 01-MAY-2016, the patient was inoculated at a hospital with ZOSTAVAX (lot number, dosage, and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 19-MAY-2016, the patient was treated at a hospital for onset of a severe vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct an proximate result of the ZOSTAVAX, and/or despite receiving ZOSTAVAX for long term prevention of shingles. The patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information was received from an attorney regarding a case in litigation concerning a female patient of unknown age. Medical history, concurrent conditions and concomitant medications were not provided. During 2012, the patient was inoculated at a pharmacy with ZOSTAVAX (lot number, dosage, and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. During 2017, the patient was treated at a Medical Center for vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct an proximate result of the ZOSTAVAX, and/or despite receiving ZOSTAVAX for long term prevention of shingles. The patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering and other damages. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information has been received on 13-APR-2018 from a lawyer and a male consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 26-FEB-2015, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster. On or about 15-MAY-2016, the patient was treated for a persistent vesicular rash, which was diagnosed with herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information has been received on 13-APR-2018 from a lawyer and a male consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. During 2014, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route, by a physician in a physician's office as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster. During 2016, the patient was treated at a physician's office for a vesicular outbreak, which was diagnosed with herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Fatigue, Incorrect route of drug administration, Malaise, Swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of feeling unwell in a 74-year-old female patient who received SHINGRIX (batch number 3Z4KL, expiry date 30th January 2020). On 2nd April 2018, the patient received the 1st dose of SHINGRIX (subcutaneous). On 2nd April 2018, unknown after receiving SHINGRIX, the patient experienced intramuscular formulation administered by other route. On 3rd April 2018, the patient experienced feeling unwell and fatigue. In April 2018, the patient experienced erythema and swelling. In April 2018, the outcome of the erythema and swelling were recovered/resolved. On an unknown date, the outcome of the feeling unwell and fatigue were recovered/resolved and the outcome of the intramuscular formulation administered by other route was unknown. The reporter considered the feeling unwell, fatigue, erythema and swelling to be almost certainly related to SHINGRIX. Additional details were provided as follows: The patient received a dose of SHINGRIX subcutaneously on 2nd April 2018 at 15:45 in right arm (back of arm near tricep), which led to Incorrect route of drug administration. The health care professional stated that patient reported redness and swelling after vaccination but was unsure when it occurred, other than that it did no occur immediately. These symptoms had since resolved but health care professional was unsure of when they resolved. Additionally, patient reported fatigue and not feeling well the next day. The health care professional was unable to provide further details regarding the patient not feeling well. These symptoms had since resolved but health care professional was unaware of when they resolved. The health care professional stated that patient did not put a call into her physician but did not, to his knowledge, visit her physician.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site macule, Injection site pain, Injection site reaction, Rash macular
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 71-year-old female patient who received SHINGRIX (batch  number XC534, expiry date 4th July 2020). On 4th April 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). In April 2018, less than a week after receiving SHINGRIX, the patient experienced injection site erythema, injection site pain and injection site muscle. On an unknown date, the outcome of the injection site erythema, injection site pain and injection site macule were not recovered/not resolved. It was unknown if the reporter considered the injection site erythema, injection site pain and injection site macule to be related to SHINGRIX. Additional details were provided as follows: The patient experienced a red, blotchy, painful area at the injection site. There was no doctor visit, hospitalization or intervention was required. The symptoms were not considered to be life threatening or disabling. The healthcare professional was unsure of the exact onset of the patient's symptoms after the vaccine was administered.
Age: 23.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Erythema, Pain in extremity
Clinical narrative: Redness, arm pain.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Erythema, Flushing
Clinical narrative: Patient received MMR, Varicella, and Hep A at 10:40 AM Patient was leaving with parent. At 11:10 AM patients face became flushed no fevers, injection sites looked normal. Patient breathing was normal. Face was just red and flushed gave BENADRYL per Dr monitor patient for 1 hour. Was good to go home. Vaccines order today by Dr. Patient's mother was aware she was on antibiotic at time of visit/injections given.
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Rash, Swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of erythema in an unknown number of patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced erythema, swelling and rash. On an unknown date, the outcome of the erythema, swelling and rash were unknown. It was unknown if the reporter considered the erythema, swelling and rash to be related to SHINGRIX. Additional information was received as follows: The age at vaccination was not applicable for this report. The healthcare professional called back in order to talk about case US2018046768, where upon discussion, she started talking about the other patients who received SHINGRIX and experienced erythema and swelling. The pharmacist was asked to collect for more information but she was in rush, as she had a patient at the pharmacy and she hurried to off the call. The healthcare professional reported that the patients had experienced same type of localized reactions were experienced by the patients after getting vaccinated with flu vaccine. This she observed with the flu shot (US2018GSK065237). No further information was provided by her. The reporter stated that the reaction was common and that is why she didn't think of it much. This case was linked to case US2018046768, reported by the same reporter.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: At time of delivery, patient pointed out to a 'bump'. She was observed for further complications before discharge. She called back (as instructed) Friday, and said her "redness" was not abating. Saturday, I called her to pharmacy to physically inspect. The redness and swelling was localized. She had no fever, spreading, no breathing issues, no itching, uticaria, but area was warm to touch. I guided her through BENADRYL (25mg) and Aspirin (325mg) therapy and cold compress. This morning she came in and the redness was spreading tad bit more, and area was hot. No other discomfort nor systemic issues. Asked her to watch for breathing and other responses. Gave her my cell phone number, to call me at all times should anything come up. Also gave her some topical BENADRYL and hydrocortisone to aid in the local response, plus her aspirin and antihistamine oral therapy. Thanks!
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Injection site erythema, Pain in extremity
Clinical narrative: Patient had substantial redness around the injection site, he stated roughly 55 square centimeters.  Also had soreness of the arm and chills the night of the vaccination. He also reported perhaps some nausea just briefly. His arm is still sore now; however, he stated that it's much better now.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Tinnitus
Clinical narrative: Patient received vaccine on Saturday 4/7/18 and started to having ringing in the ears on Monday 4/9/18 with no other symptoms.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Pt reported being diagnosed with shingles 9 days after getting first shingrix vaccine.
Age: 18.0
Sex: F
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: PEDIATRIC PATIENT WAS ADMINISTERED AN ADULT DOSE OF HEPATITIS-A VACCINE. PATIENT WAS PLACE IN OBSERVATION FOR AT MINIMUM OF 45 MINUTES FOR ANY SIDE EFFECTS. NO SIDE EFFECTS WITNESSED OR REPORTED.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Pyrexia
Clinical narrative: Within 12 hours of receiving the vaccination I experienced fever, rolling chills, aching joints that lasted another 12-14 hours.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Barium enema, Crying, Diarrhoea, Diarrhoea haemorrhagic, Intussusception
Clinical narrative: Diarrhea shortly after vaccines, called after hours that night. Went to ER on 04/13/18 and was having bloody diarrhea and crying.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Multipathogen PCR test positive, Ultrasound scan abnormal
Clinical narrative: Diarrhea shortly after vaccines, called after hours that night. Went to ER on 04/13/18 and was having bloody diarrhea and crying.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature increased, Chills, Nausea
Clinical narrative: Developed temp of 101.8, blood pressure of 146/99.  Nausea, major chills.  Late afternoon following injection. Took TYLENOL at 7:19p.m. On the 14th and again at 2:30 a.m. on the 15th.  Took ondansetron for nausea.
Age: 6.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Local reaction, Pain, Pyrexia, Swelling
Clinical narrative: vaccine received 4-9-2018 fever to 102 afternoon of 4-10-2018. Large local reaction, redness 3-4 cm. Slight swelling and pain. Fever up to 104 am of 2-11-2018.
Age: 25.0
Sex: F
Vaccine: HPV9
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site nodule, Injection site pain, Injection site pruritus
Clinical narrative: During and immediately following injection, patient felt pain that she did not experience with initial 2 vaccines. Since then, has had redness and swelling and a hard tender nodule at the site of injection. Also has potential bruising at the site and pain and itching to light touch. Has tried no medications or home remedies for these symptoms.
Age: 25.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site swelling
Clinical narrative: During and immediately following injection, patient felt pain that she did not experience with initial 2 vaccines. Since then, has had redness and swelling and a hard tender nodule at the site of injection. Also has potential bruising at the site and pain and itching to light touch. Has tried no medications or home remedies for these symptoms.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site reaction, Injection site streaking, Injection site swelling, Rash macular
Clinical narrative: Client states evening of 4/13/18 extreme pain/tenderness began in upper arm area where vaccine give. By the next morning (4/14/18) client was unable to move/use arm and noticed red blotches around injection site, swelling of arm from shoulder to elbow, and red streaks from shoulder moving down to elbow. Client states that on 4/16/18 she had continued pain and tenderness of arm as well as red "blotches" and swelling, and some mobility had returned to arm. On 4/16/18 client states that swelling has improved and she now has full use of arm. Slight redness in area, but much improved.