chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: FLUN4
Symptoms: Dyspnoea, Wheezing
Clinical narrative: A spontaneous report has been received from a pharmacist and a physician via the regulatory authority concerning a 3 year old female patient. No medical history was reported. No concomitant products were reported. On 07-Feb-2019, the patient was administered with FLUENZ TETRA (intranasal), via nasal route, for flu vaccination. On 08-Feb-2019, the patient experienced wheezy and increased work of breathing. The patient recovered from the event of wheezy on an unspecified date. The outcome of the event of increased work of breathing was unknown. The events were considered serious (important medical event) by the reporter. Sender's Comments: Wheezing and dyspnoea are not listed in the company core data sheet for Q/LAIV. Due to limited information on relevant medical history, concurrent diseases, concomitant medications, outcome of dyspnoea, detailed aetiological and diagnostic work up (pulmonary function tests, allergological work up) it is not possible to make a conclusive assessment of the causal relationship of the events and suspect drug.
Sex: F
Vaccine: HPV9
Symptoms: No adverse event, Product impurity
Clinical narrative: This spontaneous report has been received from a pharmacist via company representative, concerning to a female patient of unknown age and ethnicity. The patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications were not provided. On an unspecified date (also reported as "when the patient was 13 years old"), she received the first dose of GARDASIL 9 intramuscularly or GARDASIL intramuscularly (lot# and expiration date were not provided) (it could not be further clarified which precisely was). On an unspecified day in December 2018, the patient received the second dose of GARDASIL 9 intramuscularly (lot# and expiration date were not provided) or GARDASIL intramuscularly (lot# and expiration date were not provided) (it could not be further clarified which precisely was). On an unspecified day in February 2019 , the patient received her third dose of GARDASIL 9. On an unspecified day of February 2019 (reported as last week) the pharmacist found a "small white, flaky material" inside the vial GARDASIL 9, along the wall, underneath the rubber stopper, prior to puncturing the vial, after the vial was agitated by the pharmacist. The dose was not administered. It was reported that the vaccine did not have temperature excursions and it was monitored with data logger. No adverse event was reported. The outcome for the product impurity issue was unknown. The causal relationship between the product impurity and GARDASIL 9 was unknown.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning an elderly female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX vaccine by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 17-MAR-2010, at age 72, the patient was administered the ZOSTAVAX vaccine by a healthcare provider at a county health department (lot number, dosage and route of administration not provided). On an unknown date, the patient was treated by a healthcare provider for the following injury resulting from her ZOSTAVAX use: Shingles. The outcome of the shingles is unknown. The patient claimed damages as a result of: injury to herself and economic losses. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX vaccine by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On an unknown date in 2016, at approximately age 64, the patient was administered the ZOSTAVAX vaccine by a healthcare provider (lot number, dosage and route of administration not provided). On an unknown date, the patient was treated by a healthcare provider for the following injury resulting from her ZOSTAVAX use: Shingles. The outcome of the shingles is unknown. The patient claimed damages as a result of: injury to herself, loss of services, and economic losses. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: HEPA
Symptoms: Asthma, Dyspnoea, Obstructive airways disorder, Rash, Urticaria
Clinical narrative: This case was reported by a physician via other manufacturer and described the occurrence of asthma in a 67-year-old female patient who received HAVRIX 1440 for prophylaxis. The patient had a Family History of coronary artery disease, diabetes mellitus, skin cancer, acute myocardial infarction (father died at 51) and stroke syndrome. Concurrent medical conditions included aldosteronism, angina pectoris (Angina Pectoris Prinzmetal's), anxiety disorder, bipolar disorder, carotid artery stenosis, chronic kidney disease (Stage 2), chronic obstructive pulmonary disease, congestive heart failure, fatty liver, fibromyalgia, gastroesophageal reflux disease, viral hepatitis c, hiatal hernia, hyperlipidemia, hypertension (systemic), hypokalemia, hypothyroidism, irritable bowel syndrome, migraine headache, obesity, osteoarthritis (Localized Primary Knee), Takotsubo syndrome, tremor, drug allergy (contrast dyes skin rashes and hives), latex allergy, allergic reaction to analgesics, insect bite allergy and sulfonamide allergy. Concomitant products included umeclidinium bromide, ANORO ELLIPTA, Aspirin, CRESTOR, buspirone hydrochloride, Calcium, carvedilol, Clindamycin Phosphate, clobetasol propionate, Hydroxyzine, lamotrigine, spironolactone, Levothyroxine Sodium, triamcinolone acetonide, nitroglycerine, NITROSTAT, cyanocobalamin, clonazepam, DEPLIN, DEXILANT, Dicyclomine Hydrochloride, FIBERCON, KLOR-CON, LASIZX, lisinopril, SEROQUEL and FETZIMA. On an unknown date, the patient received HAVRIX 1440 at an unknown dose. On an unknown date, unknown after receiving HAVRIX 1440, the patient experienced asthma, shortness of breath, rash, hives and airways obstruction. On an unknown date, the outcome of the asthma, shortness of breath, rash, hives and airways obstruction were unknown. It was unknown if the reporter considered the asthma, shortness of breath, rash, hives and airways obstruction to be related to HAVRIX 1440. Additional details were provided as follows: The age at vaccination was not reported. It was unknown if the patient had the allergies to Azithromycin, Tramadol HCl, SKALEXIN, LIPITOR or DEMEROL before or after vaccination with HAVRIX.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site pain, Injection site reaction, Insomnia, Musculoskeletal stiffness
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of shoulder pain in a 52-year-old female patient who received FLUARIX QUADRIVALENT 2018-2019 season (batch number 75TA2, expiry date 30th June 2019) for prophylaxis. On 11th September 2018, the patient received FLUARIX QUADRIVALENT 2018-2019 season (intramuscular) .5 ml. In October 2018, less than a year after receiving FLUARIX QUADRIVALENT 2018-2019 season, the patient experienced shoulder pain. On 13th November 2018, the patient experienced rotator cuff tendinitis. In January 2019, the patient experienced difficulty sleeping, stiffness shoulder and mobility decreased. On an unknown date, the patient experienced frozen shoulder. The patient was treated with meloxicam and Physical Therapy (Nos). On an unknown date, the outcome of the shoulder pain was recovering/resolving and the outcome of the rotator cuff tendinitis, frozen shoulder, difficulty sleeping, stiffness shoulder and mobility decreased were not recovered/not resolved. It was unknown if the reporter considered the shoulder pain, rotator cuff tendinitis, frozen shoulder, difficulty sleeping, stiffness shoulder and mobility decreased to be related to FLUARIX QUADRIVALENT 2018-2019 season. Additional details were reported as follows: The practice supervisor reported that a patient received FLUARIX vaccine on left deltoid. The patient was in the office on 17th October 2018 complaining of left shoulder pain. The patient was referred to an orthopedist and saw one on 13th November 2018 and was diagnosed with rotator cuff tendinitis following flu vaccine injection. The patient was prescribed meloxicam and physical therapy. The patient saw the orthopedist again in January 2019 and she had some decrease in pain, but her shoulder was getting stiffer and stiffer and she was now having trouble with any kind of motion. This was also causing her to not sleep very well. It was diagnosed that the tendinitis had progressed into frozen shoulder and she was now receiving treatment for that condition. The patient saw her general practitioner (GP) in February 2019 and the problem was continuing till the reporting time. Emergency room visit required.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Periarthritis, Rotator cuff syndrome
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of shoulder pain in a 52-year-old female patient who received FLUARIX QUADRIVALENT 2018-2019 season (batch number 75TA2, expiry date 30th June 2019) for prophylaxis. On 11th September 2018, the patient received FLUARIX QUADRIVALENT 2018-2019 season (intramuscular) .5 ml. In October 2018, less than a year after receiving FLUARIX QUADRIVALENT 2018-2019 season, the patient experienced shoulder pain. On 13th November 2018, the patient experienced rotator cuff tendinitis. In January 2019, the patient experienced difficulty sleeping, stiffness shoulder and mobility decreased. On an unknown date, the patient experienced frozen shoulder. The patient was treated with meloxicam and Physical Therapy (Nos). On an unknown date, the outcome of the shoulder pain was recovering/resolving and the outcome of the rotator cuff tendinitis, frozen shoulder, difficulty sleeping, stiffness shoulder and mobility decreased were not recovered/not resolved. It was unknown if the reporter considered the shoulder pain, rotator cuff tendinitis, frozen shoulder, difficulty sleeping, stiffness shoulder and mobility decreased to be related to FLUARIX QUADRIVALENT 2018-2019 season. Additional details were reported as follows: The practice supervisor reported that a patient received FLUARIX vaccine on left deltoid. The patient was in the office on 17th October 2018 complaining of left shoulder pain. The patient was referred to an orthopedist and saw one on 13th November 2018 and was diagnosed with rotator cuff tendinitis following flu vaccine injection. The patient was prescribed meloxicam and physical therapy. The patient saw the orthopedist again in January 2019 and she had some decrease in pain, but her shoulder was getting stiffer and stiffer and she was now having trouble with any kind of motion. This was also causing her to not sleep very well. It was diagnosed that the tendinitis had progressed into frozen shoulder and she was now receiving treatment for that condition. The patient saw her general practitioner (GP) in February 2019 and the problem was continuing till the reporting time. Emergency room visit required.
Age: 16.0
Sex: F
Vaccine: HEPAB
Symptoms: Off label use, Product administered to patient of inappropriate age, Syncope
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of faint in a 16-year-old female patient who received TWINRIX adult for prophylaxis. Concurrent medical conditions included woozy. On 28th February 2019, the patient received TWINRIX adult 1 ml. On 28th February 2019, less than an hour after receiving TWINRIX adult, the patient experienced faint (serious criteria GSK medically significant) and inappropriate age at vaccine administration. On an unknown date, the patient experienced off label use. On an unknown date, the outcome of the faint was recovered/resolved and the outcome of the off label use and inappropriate age at vaccine administration were unknown. It was unknown if the reporter considered the faint to be related to TWINRIX adult. Additional details reported as follows: The pharmacist reported that, in the last evening the 16 years old patient was given a dose of TWINRIX Adult on the left deltoid, which led to off label used and inappropriate age at vaccine administration. The patient was a little woozy before but within 2 minutes after vaccination, the patient fainted and was out for about 30 to 60 seconds.
Age: 1.17
Sex: F
Vaccine: DTAPIPV
Symptoms: Body temperature increased
Clinical narrative: Mother called office on 3/6/19 with report of temp 103. Nurse call on 3/8/19 reveals no further temps, doing well.
Age: 1.75
Sex: M
Vaccine: MMRV
Symptoms: Eye movement disorder, Muscle twitching, Pyrexia, Rash generalised, Screaming
Clinical narrative: Exactly 11 days after mmrv he developed high fever of 106f. He had a blank stare for about a week that was associated with a neck twitch and eyes rolled around here and there. Had a full rash from head to toe and it started on the scalp/hairline. Screamed alot.
Age: 1.75
Sex: M
Vaccine: MMRV
Symptoms: Staring, Viral infection
Clinical narrative: Exactly 11 days after mmrv he developed high fever of 106f. He had a blank stare for about a week that was associated with a neck twitch and eyes rolled around here and there. Had a full rash from head to toe and it started on the scalp/hairline. Screamed alot.
Age: 34.0
Sex: F
Vaccine: FLU4, PPV, TDAP
Symptoms: Inflammation, Injection site erythema, Pyrexia
Clinical narrative: Patient called this morning and indicated that she had a fever of 103 and some redness at the injection site. She was told that flu-like or cold-like symptoms, including fever, were possible.  She was advised to take ibuprofen or acetaminophen for the fever and inflammation.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Body temperature increased, Chills, Fatigue, Feeling abnormal, Injection site pain
Clinical narrative: I felt fine after the shot. About four hours later, there was pain in the area around the shot. In the middle of the night, around 3 a.m. I woke up feeling chilled, somewhat generally achy, and quite "bad." At 5:30 a.m. I took my temp, and it was 4-5 degrees above my normal temperature. About three hours later, my temp reverted to normal, and I felt worn but better. It is now 1 p.m., my temp is normal, but not surprisingly I feel rather worn after doing an hour of errands and work.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Middle insomnia, Pain
Clinical narrative: I felt fine after the shot. About four hours later, there was pain in the area around the shot. In the middle of the night, around 3 a.m. I woke up feeling chilled, somewhat generally achy, and quite "bad." At 5:30 a.m. I took my temp, and it was 4-5 degrees above my normal temperature. About three hours later, my temp reverted to normal, and I felt worn but better. It is now 1 p.m., my temp is normal, but not surprisingly I feel rather worn after doing an hour of errands and work.
Age: 1.33
Sex: M
Vaccine: DTAP
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Redness, warm to touch and swelling.
Age: 1.5
Sex: M
Vaccine: VARCEL
Symptoms: Injection site reaction, Lethargy, Pyrexia, Urticaria
Clinical narrative: About 9 days after the vaccine, patient developed a fever and became extremely lethargic. The following day he developed a large welt at the injection site. Fever/ lethargy lasted several days.
Age: 0.17
Sex: M
Vaccine: HEP, PNC13
Symptoms: Immediate post-injection reaction, Injection site swelling
Clinical narrative: LPN administered Hep B and PREVNAR into right thigh. Immediate swelling noted to area. Quarter sized. Observed for 20-30 minutes. Dr in room to see patient. Swelling had gone. Patient home with Mom. (Patient also received PENTACEL on same day but in left thigh, left thigh with no reaction.)
Age: 28.0
Sex: F
Vaccine: HEPAB, PPV
Symptoms: Cellulitis, Headache, Injection site induration, Injection site pain, Injection site rash
Clinical narrative: Patient complained of soreness and swelling of her left deltoid. She also had rashes near the site of injection and the armpit area. According to the patient, the rashes were painful and felt like there is a rock or a bump when pressed on them. The rashes were developed on the night of 03/06/2019 as well as her headache. Patient did not have fever. Patient was admitted to the hospital on 03/08/2019 and was diagnosed with cellulitis.
Age: 28.0
Sex: F
Vaccine: HEPAB, PPV
Symptoms: Injection site swelling, Musculoskeletal discomfort, Peripheral swelling, Rash
Clinical narrative: Patient complained of soreness and swelling of her left deltoid. She also had rashes near the site of injection and the armpit area. According to the patient, the rashes were painful and felt like there is a rock or a bump when pressed on them. The rashes were developed on the night of 03/06/2019 as well as her headache. Patient did not have fever. Patient was admitted to the hospital on 03/08/2019 and was diagnosed with cellulitis.
Age: 0.33
Sex: U
Vaccine: DTAPIPVHIB, PNC13, RV1
Symptoms: Platelet count increased, Purpura, Urine analysis normal, Vasculitis
Clinical narrative: 9 days following administration of vaccines child developed purpura / vasculitis on lower extremities. Purpura / vasculitis came and went for a total of 12.5 weeks. Child had no other symptoms during the 12.5 weeks. Blood work was conducted 3 weeks following onset of purpura/ vasculitis, found above normal platelet levels. Purpura / vasculitis self resolved after 12.5 weeks with no intervention.  Urinary analysis was conducted 6 months after purpura /vasculitis resolved. Urinary analysis was normal and showed no renal involvement.
Age: 61.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Asthenia, Blood test, Chills, Fatigue, Headache
Clinical narrative: Severe headache lasting the first 10 hours after shots. Next 2 days flu like chills and weakness and extreme fatigue causing hours of deep sleep. Following day extreme fatigue causing hours of sleep. My ability to conduct normal daily routine was definitely impaired for at least 3 days following my shots. I am writing this report on Friday late afternoon following vaccinations on Tuesday late afternoon.
Age: 61.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Hypersomnia, Influenza like illness, Loss of personal independence in daily activities
Clinical narrative: Severe headache lasting the first 10 hours after shots. Next 2 days flu like chills and weakness and extreme fatigue causing hours of deep sleep. Following day extreme fatigue causing hours of sleep. My ability to conduct normal daily routine was definitely impaired for at least 3 days following my shots. I am writing this report on Friday late afternoon following vaccinations on Tuesday late afternoon.
Age: 5.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Cellulitis
Clinical narrative: Patient had a cellulitis reaction same day of vaccine. Cellulitis reaction measured 8.4 in x 6 in.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Chills, Fatigue, Pain, Pyrexia
Clinical narrative: On 3/5 woke up with chills, achiness all over, stomach ache, had a fever (did not take temp) and total fatigue. Symptoms lasted for 3 days until 3/7. By the 3rd day it was just the stomach that bothered her. TUMS did not do anything. Feels fine today.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Cough, Erythema, Pruritus, Rhinorrhoea, Skin warm
Clinical narrative: On Sunday, arm started itching, it was red and hot. On the 3/4 it was getting worse. Tried putting ice and heat but itching did not stop. Went to the doctor on 3/7, doctor recommended Benadryl (day and night) and use of cold towel. The symptoms have improved; not as itchy as it used to be. Ha a bit of a cough and nose running that disappeared. Patient took some Loratadine for allergies.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling
Clinical narrative: ARM WAS SWOLLEN AND RED.
Age: 4.0
Sex: U
Vaccine: DTAPHEPBIP, HEP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report has been received from a certified medical assistant regarding to a 4-year-old patient. The patient's concurrent conditions, medical history and drug allergies were not reported. On 13-FEB-2019, the patient was vaccinated with a dose of RECOMBIVAX HB (lot # R006746 and expiration date 09-NOV-2020) (dose number and anatomical location of vaccination were not reported) and PEDIARIX (anatomical location of vaccination was not reported) (Inappropriate dose of vaccine administered); both administered for prophylaxis. No adverse effect was reported.
Age: 66.0
Sex: F
Vaccine: TDAP
Symptoms: Blood test normal, Cardiac monitoring normal, Palpitations, Sleep disorder, Tremor
Clinical narrative: My whole body started shaking an hour later as soon as I got home. Heart started to race. Went away but came back every two hours during the night. The following week went into doctors office and they took some blood work and also sent me home with a heart monitor. Seeing that it was only happening at night or early morning. Couldn't get to doctors office quick enough to show them the shakes. Weeks later got better and not as frequent at night. Now It only wakes me in the morning with the shakes or trembling trembling hands. So hard to describe.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site reaction, Rash, Urticaria
Clinical narrative: Rash on left arm, 2" whelp to posterior proximal left arm, no pain, no itching. Cortisone cream as needed for itching. Seen in local Emergency Room on 02/28/2019.
Age: 22.0
Sex: F
Vaccine: TDAP
Symptoms: Rash
Clinical narrative: Rash on forehead and side of face began approximately 2 days after injection. Rash had resolved roughly 24 hours later.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Flushing, Injection site pain, Nausea, Pain, Pyrexia
Clinical narrative: Nausea, fever, aches, flush face, pain around injection site.
Age: 2.0
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13
Symptoms: Vaccination error
Clinical narrative: Patient received unneeded doses of ACTHIB and PREVNAR 13.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Lethargy, Pain
Clinical narrative: Sore at site of injection. Lethargic and achy the whole day.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Rash vesicular, Scab
Clinical narrative: Pain, soreness, shingles like lesions at injection site - started day after vaccine, some lesions crusting/scabbing day 2 after vaccine, redness and tenderness continues.
Age: 0.0
Sex: M
Vaccine: MMR
Symptoms: Aphasia, Diarrhoea, Pyrexia, Vomiting
Clinical narrative: Went into the doctors office totally normal. About 8 hours after the vaccination ALL speech was GONE. He no longer was talking. Also 105 fever. Throwing up uncontrollable and diarrhea. Speech has slowly been coming back with speech therapy.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: L Arm red, swollen and painful.
Age: 2.0
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Right Thigh is hot and hard to touch. Thigh turned red and swollen and covered around half of the thigh. Cold Compress and Tylenol.
Age: 0.58
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site mass, Injection site nodule, Injection site swelling
Clinical narrative: Redness and swelling at the injection site. Large lump or knot under injection site.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discolouration, Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: Sore & red at injection site by 10 PM after given vaccine (7 hours later) with area covering 3x2 inches. Area was tender to touch and very painful and hot and hard. Pain was gone by 3/5 while some discoloration remained. Patient took ADVIL Friday evening.
Age: 14.0
Sex: M
Vaccine: FLU4
Symptoms: Rash, Rash pruritic, Rash vesicular
Clinical narrative: 14 YOM pt accompanied by father with c/o localized pruritic vesicular rash on back x 1 day. Pt reports rash started 1 hr after influenza vaccine was given. Pt denies any other symptoms. Pt will be treated with acyclovir PO for possible shingles and triamcinolone topical cream. Pt to f/u with his PCP upon return and ER recommendations given. Pt and parent verbalized understanding.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect route of product administration
Clinical narrative: Vaccine was maladministered via subcutaneous route instead of approved intramuscular route. Patient's wife who also received the vaccine called the morning administration after to report.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Mental disorder, Pain
Clinical narrative: The patient said next day she felt as if a truck ran her over. Hurt all over and was mentally "out-of-it." This feeling lasted for days after injection. She consulted with her primary care md. She stayed home and rested but I do not know if pcp prescribed any medications. Unknown patient not answering phone.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Unevaluable event
Clinical narrative: Patient and her husband (who also had SHINGRIX vaccination on same date/time) went to visit grandchildren. 2 older grandchildren had chickenpox vaccine previously, baby grandchild (age 11 mos) had not had vaccine yet and developed chickenpox from grandparents exposure on said visit... no one else in family came down with chicken pox. Had previously told mother they do not vaccinate children <1 yr old because "babies don't get chickenpox" (per grandmother).
Age: 82.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Patient presented to pharmacy today with a cantaloupe size swollen and red area. Area appeared to have streaks as well, and was warm to the touch. Recommended that patient go to the physician to be seen. He received 2 rx today to help with the redness and swelling--a steroid dose pack and then a steroid cream.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pain
Clinical narrative: Red, swollen area at site of injection, grew to about 3inches by 2 inches; swelling lasted a week; redness lasted 2 weeks. Pain at site; took TYLNEOL for 4 days. Pain when moving arm; lasted a week.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Eye pain, Feeling abnormal, Headache
Clinical narrative: I woke up after 3 1/2 hours of sleep and then every hour, peeing< > being thirsty, burning with a fever and every cell and goose bump of my body hurting. My head, my eyes, my joints, my skin, every injury I have ever had, my hands, fingers, toes, tendons, intestines. And chills. Never been this sick in years, except for when I got the first one of these. And cannot lift my arm at all. Lymph nodes sore, besides the muscles themselves. Cracking headache and shooting pains in my head. Trying to move around to make the time go by and get some things done, but absolutely sick and MISERABLE! It is really quite extreme. I never get a fever, even when I have a flu (or other immunizations)! Having a truly violent reaction to it.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Lymph node pain, Malaise, Middle insomnia, Mobility decreased, Myalgia
Clinical narrative: I woke up after 3 1/2 hours of sleep and then every hour, peeing< > being thirsty, burning with a fever and every cell and goose bump of my body hurting. My head, my eyes, my joints, my skin, every injury I have ever had, my hands, fingers, toes, tendons, intestines. And chills. Never been this sick in years, except for when I got the first one of these. And cannot lift my arm at all. Lymph nodes sore, besides the muscles themselves. Cracking headache and shooting pains in my head. Trying to move around to make the time go by and get some things done, but absolutely sick and MISERABLE! It is really quite extreme. I never get a fever, even when I have a flu (or other immunizations)! Having a truly violent reaction to it.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Nocturia, Pain, Pain of skin, Pyrexia, Thirst
Clinical narrative: I woke up after 3 1/2 hours of sleep and then every hour, peeing< > being thirsty, burning with a fever and every cell and goose bump of my body hurting. My head, my eyes, my joints, my skin, every injury I have ever had, my hands, fingers, toes, tendons, intestines. And chills. Never been this sick in years, except for when I got the first one of these. And cannot lift my arm at all. Lymph nodes sore, besides the muscles themselves. Cracking headache and shooting pains in my head. Trying to move around to make the time go by and get some things done, but absolutely sick and MISERABLE! It is really quite extreme. I never get a fever, even when I have a flu (or other immunizations)! Having a truly violent reaction to it.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypotension
Clinical narrative: Systolic Hypotension the day after administration of the vaccine. She was on the treadmill when she felt hypotensive. She denied overdose on hypertension medications.
Age: 6.0
Sex: F
Vaccine: MMR
Symptoms: Erythema, Hypersensitivity, Immediate post-injection reaction, Injection site rash, Limb discomfort
Clinical narrative: Immediatley after the vaccine, patient complained her arm was tingly and itchy. This continued despite the cold compresses and warm compresses we alternated with. By the evening her arm was slightly swollen, red, and blotchy looking. The next morning she didnt say much about it and went to school didnt complain about it at all other than it being uncomfortable. Appearance wise it seemed alot more irritated so we continued with comfort of warm and cool compresses because her doctor said this could happen and was normal I even used calmine lotion which I use often when she plays outside and brushes up on poison ivy. The following day she complained it felt worse, she showed me her arm and it indeed looked worse. It was swollen to almost the size of a baseball, bright bright red and painful yet extremely itchy. There were raised bumps surrounding it and she even had a linear rash across her belly and what looked like hives. I called the pediatrician on call number and the nurse told me this was all very normal and not considered a allergic reaction. I administered her Benadryl and the hive type rash was gone however the bumbs around thw injection and the awful swelling was still present. She clearly had a allergic reaction, if your child was allergic to peanuts would you keep giving them to them because her doctor claimed it was the only real source of protein or would you find otherways to get the protein she needed?
Age: 6.0
Sex: F
Vaccine: MMR
Symptoms: Pain in extremity, Paraesthesia, Peripheral swelling, Pruritus, Rash
Clinical narrative: Immediatley after the vaccine, patient complained her arm was tingly and itchy. This continued despite the cold compresses and warm compresses we alternated with. By the evening her arm was slightly swollen, red, and blotchy looking. The next morning she didnt say much about it and went to school didnt complain about it at all other than it being uncomfortable. Appearance wise it seemed alot more irritated so we continued with comfort of warm and cool compresses because her doctor said this could happen and was normal I even used calmine lotion which I use often when she plays outside and brushes up on poison ivy. The following day she complained it felt worse, she showed me her arm and it indeed looked worse. It was swollen to almost the size of a baseball, bright bright red and painful yet extremely itchy. There were raised bumps surrounding it and she even had a linear rash across her belly and what looked like hives. I called the pediatrician on call number and the nurse told me this was all very normal and not considered a allergic reaction. I administered her Benadryl and the hive type rash was gone however the bumbs around thw injection and the awful swelling was still present. She clearly had a allergic reaction, if your child was allergic to peanuts would you keep giving them to them because her doctor claimed it was the only real source of protein or would you find otherways to get the protein she needed?
Age: 6.0
Sex: F
Vaccine: MMR
Symptoms: Rash macular, Skin irritation, Urticaria
Clinical narrative: Immediatley after the vaccine, patient complained her arm was tingly and itchy. This continued despite the cold compresses and warm compresses we alternated with. By the evening her arm was slightly swollen, red, and blotchy looking. The next morning she didnt say much about it and went to school didnt complain about it at all other than it being uncomfortable. Appearance wise it seemed alot more irritated so we continued with comfort of warm and cool compresses because her doctor said this could happen and was normal I even used calmine lotion which I use often when she plays outside and brushes up on poison ivy. The following day she complained it felt worse, she showed me her arm and it indeed looked worse. It was swollen to almost the size of a baseball, bright bright red and painful yet extremely itchy. There were raised bumps surrounding it and she even had a linear rash across her belly and what looked like hives. I called the pediatrician on call number and the nurse told me this was all very normal and not considered a allergic reaction. I administered her Benadryl and the hive type rash was gone however the bumbs around thw injection and the awful swelling was still present. She clearly had a allergic reaction, if your child was allergic to peanuts would you keep giving them to them because her doctor claimed it was the only real source of protein or would you find otherways to get the protein she needed?
Age: 21.0
Sex: F
Vaccine: HEP
Symptoms: Injection site erythema, Injection site nodule, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Redness, swelling, heat, pain at injection site resulting in a knot.
Age: 1.25
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Erythema multiforme, Henoch-Schonlein purpura, Urticaria
Clinical narrative: Urticaria multiforme: raised red and purple lesions triggered. The doc diagnosis of Henoch-Schonlein purpura (emenously) and given massive doses steroids over phone.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Nausea, Pain in extremity, Swelling, Ultrasound scan
Clinical narrative: Received 1st SHINGRIX shot Nov. 4th, 2018. Suffered usual arm soreness (moderately - severe), tiredness and nausea. Lasted about 4-5 days. Approx. 2 wks later went to Doctor (Nov. 14th?) with swelling along left side of neck. Now has spread to both sides.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: X-ray
Clinical narrative: Received 1st SHINGRIX shot Nov. 4th, 2018. Suffered usual arm soreness (moderately - severe), tiredness and nausea. Lasted about 4-5 days. Approx. 2 wks later went to Doctor (Nov. 14th?) with swelling along left side of neck. Now has spread to both sides.
Age: 2.0
Sex: F
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Erythema multiforme, Oedema, Urticaria
Clinical narrative: Urticaria however startup 4.5 days after s/b with urticaria multiforme and edema of joints.
Age: 8.0
Sex: F
Vaccine: FLU4
Symptoms: Peripheral swelling, Pruritus
Clinical narrative: Swelling/itching/to Left arm.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Body temperature increased, Injection site discomfort, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Mom states there was swelling noted from shoulder to elbow. Notes of redness and warmth to the area. Patient was given TYLENOL/ibuprofen for swelling, temperature elevation (101)-OTC. Mom denied shortness of breath, pain but confirmed itching and discomfort to the injection site.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site warmth
Clinical narrative: Mom states there was swelling noted from shoulder to elbow. Notes of redness and warmth to the area. Patient was given TYLENOL/ibuprofen for swelling, temperature elevation (101)-OTC. Mom denied shortness of breath, pain but confirmed itching and discomfort to the injection site.
Age: 75.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Injection site pain, Rash, Rash pruritic
Clinical narrative: Rash over trunk of body spreading during following months to legs, feet and upper arms. No treatment. 2 Skin biopsies with finding of Granuloma Annulare.
Age: 75.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Biopsy skin abnormal, Granuloma annulare, Rash
Clinical narrative: Rash over trunk of body spreading during following months to legs, feet and upper arms. No treatment. 2 Skin biopsies with finding of Granuloma Annulare.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood test, Chest X-ray, Computerised tomogram, Headache, Heart rate increased
Clinical narrative: Increased heart rate heart flu symptoms headache.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza
Clinical narrative: Increased heart rate heart flu symptoms headache.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pain, Pain in extremity
Clinical narrative: Patient got 2 vaccitions on 1/22/2019 (FLUZONE HD TOP LEFT ARM, AND PNEUMOVAX FEW CM LOWER ON LEFT ARM). She noticed pain in the arm after vaccination, but passed it as part of routine post vaccination pain. She shared this information with a nurse practitioner in late Jan, since she is still experiencing pain. Until now, she still can't lift her arm without feeling instant pain. If her arm stays in a single position for a length of time, it will start to hurt. She is make an appointment to see a doctor soon to have this evaluated.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache
Clinical narrative: Headache upon waking and continuing on 03/09/2019.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Muscle spasms, Tremor
Clinical narrative: Severe muscle cramping, right calf and foot: about 8 hours after vaccination, resolved on its own within 2 hours. Severe chills, shivering and shaking: about 11 hours after vaccination, lasted about 3 hours; hot shower helped to resolve. Fatigue: began following day, morning of 03/07/2019, and lasted about 36 hours, resolved on its own.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Electrocardiogram, Heart rate increased, Hepatic pain, Muscle spasms
Clinical narrative: High fever muscle cramps joint pain whole body rapid heartbeat stomach nausea liver pain.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Nausea, Pyrexia
Clinical narrative: High fever muscle cramps joint pain whole body rapid heartbeat stomach nausea liver pain.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Injection site erythema, Injection site pain, Nausea
Clinical narrative: Patient reported redness and soreness at the injection site, as well as joint pain throughout her body. She also reported nausea. These symptoms resolved 3 days after onset.
Sex: U
Vaccine: MMRV
Symptoms: Blood test, Crying, Decreased appetite, Ear infection, Ear pain
Clinical narrative: Feb. 4 rash appeared on right shoulder, it seemed very sensitive to the touch as he would shy away from me if I tried to touch that shoulder (looked like chicken pox, I have a photo from Feb. 6) rash became more concentrated and scabby but no longer sensitive to touch(I have a photo from Feb. 21, Feb. 27, and today Mar. 10), the rash seems less thick now and possibly fading but still present. Feb. 4 to Feb. 7 fever ranging from 102 -103 able to be brought down with tylenol and ibuprofen, fever worse at night. Lethargy, decreased appetite, very clingy and fussy Feb. 7 to about Feb.11 severe nasal congestion, unable to nurse. He's never had such severe nasal congestion to the point he couldn't nurse, sleep unless sitting up, etc. Feb. 11 until present has been acting as if right ear is hurting him. Puts his finger in his ear, pulls his hair, hits himself in the head, cries, fussy and clingy. Mar 6 to present severe nasal congestion again. Not as bad as in February but having trouble nursing, sleeping, etc. Sleeping more during the day than normal, appetite decreased, rash still present on right shoulder.
Sex: U
Vaccine: MMRV
Symptoms: Insomnia, Irritability, Lethargy, Nasal congestion, Pyrexia
Clinical narrative: Feb. 4 rash appeared on right shoulder, it seemed very sensitive to the touch as he would shy away from me if I tried to touch that shoulder (looked like chicken pox, I have a photo from Feb. 6) rash became more concentrated and scabby but no longer sensitive to touch(I have a photo from Feb. 21, Feb. 27, and today Mar. 10), the rash seems less thick now and possibly fading but still present. Feb. 4 to Feb. 7 fever ranging from 102 -103 able to be brought down with tylenol and ibuprofen, fever worse at night. Lethargy, decreased appetite, very clingy and fussy Feb. 7 to about Feb.11 severe nasal congestion, unable to nurse. He's never had such severe nasal congestion to the point he couldn't nurse, sleep unless sitting up, etc. Feb. 11 until present has been acting as if right ear is hurting him. Puts his finger in his ear, pulls his hair, hits himself in the head, cries, fussy and clingy. Mar 6 to present severe nasal congestion again. Not as bad as in February but having trouble nursing, sleeping, etc. Sleeping more during the day than normal, appetite decreased, rash still present on right shoulder.
Sex: U
Vaccine: MMRV
Symptoms: Rash, Rash vesicular, Scab, Tenderness
Clinical narrative: Feb. 4 rash appeared on right shoulder, it seemed very sensitive to the touch as he would shy away from me if I tried to touch that shoulder (looked like chicken pox, I have a photo from Feb. 6) rash became more concentrated and scabby but no longer sensitive to touch(I have a photo from Feb. 21, Feb. 27, and today Mar. 10), the rash seems less thick now and possibly fading but still present. Feb. 4 to Feb. 7 fever ranging from 102 -103 able to be brought down with tylenol and ibuprofen, fever worse at night. Lethargy, decreased appetite, very clingy and fussy Feb. 7 to about Feb.11 severe nasal congestion, unable to nurse. He's never had such severe nasal congestion to the point he couldn't nurse, sleep unless sitting up, etc. Feb. 11 until present has been acting as if right ear is hurting him. Puts his finger in his ear, pulls his hair, hits himself in the head, cries, fussy and clingy. Mar 6 to present severe nasal congestion again. Not as bad as in February but having trouble nursing, sleeping, etc. Sleeping more during the day than normal, appetite decreased, rash still present on right shoulder.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Nodule, Tenderness
Clinical narrative: I have a new nodule on the outer edge of my collarbone that is quite sore. I have never had this before. The soreness is approximately 1 inch diameter. It hurts when I touch it/press on it. It is not unbearable but it is sore. Very strange.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature increased, Chills, Fatigue, Headache, Lethargy
Clinical narrative: Severe arm pain, myalgia, chills, temperature orally 99.9; severe nausea, headache, lethargy, fatigue. Nausea, myalgia and headache lasted approximately 12 hours; fatigue-24 hours.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Nausea, Pain in extremity
Clinical narrative: Severe arm pain, myalgia, chills, temperature orally 99.9; severe nausea, headache, lethargy, fatigue. Nausea, myalgia and headache lasted approximately 12 hours; fatigue-24 hours.
Age: 1.42
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Huge, swollen leg, very very hard, bright red and warm to the touch.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Pain in extremity, Rotator cuff syndrome
Clinical narrative: The patient's spouse reported the patient had a sore arm that has continued since receiving the injection and she is now unable to raise her arm. The pharmacist called the patient and encouraged her to go to urgent care to have this checked out to rule out SIRVA. The patient saw provider. The provider did not think the problem was SIRVA. She thought it was a rotator cuff injury. The provider gave the patient a muscle relaxant and NSAID and exercises.
Age: 1.83
Sex: M
Vaccine: MMR
Symptoms: Dysphemia
Clinical narrative: Stuttering started the following morning after receiving the MMR and has continued frequently since. Prior to vaccine patient did not stutter and has excellent speech and vocabulary for a 22 month old.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash, Nausea, Pain, Pain in extremity
Clinical narrative: Moderately sore arm, rash / redness size I?d softball at site of shot; body aches; nausea.
Age: 33.0
Sex: M
Vaccine: FLU4
Symptoms: Muscular weakness, Pain, Pain in extremity, Product administered at inappropriate site
Clinical narrative: Pt called and said that he got flu shot 3 weeks ago. His arm is still weak and pain. When he was moving his arm in certain directions  and lifting something, he felt pain and weak. Also, he went the check out with the doctor. The doctor said that the flu shot caused the pain. The doctor also said that if the injection site was too high, it could caused pain. The patient said that he remembered that the injection site was up high near his shoulder.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Decreased appetite, Dry mouth, Fatigue, Headache
Clinical narrative: Immediately after shot severe arm pain where had shot from 1 hour after shot did not feel well. Tired. By the evening headache. Body aches. Stomach ache. Feverish. By next day in bed with same flu like symptoms and red rash on both face, cheeks and fever of 101 at 5 pm. No appetite. Woke up next day extreme dry mouth. Next day being today March 9. No more symptoms except tired from ordeal.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Influenza like illness, Injection site pain, Malaise, Pain
Clinical narrative: Immediately after shot severe arm pain where had shot from 1 hour after shot did not feel well. Tired. By the evening headache. Body aches. Stomach ache. Feverish. By next day in bed with same flu like symptoms and red rash on both face, cheeks and fever of 101 at 5 pm. No appetite. Woke up next day extreme dry mouth. Next day being today March 9. No more symptoms except tired from ordeal.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Rash, Rash erythematous
Clinical narrative: Immediately after shot severe arm pain where had shot from 1 hour after shot did not feel well. Tired. By the evening headache. Body aches. Stomach ache. Feverish. By next day in bed with same flu like symptoms and red rash on both face, cheeks and fever of 101 at 5 pm. No appetite. Woke up next day extreme dry mouth. Next day being today March 9. No more symptoms except tired from ordeal.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Pt states that she has had arm pain since getting this vaccination and that it has made it hard for her to lift her arm over her head.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Eyelid ptosis, Paranasal sinus discomfort
Clinical narrative: Patient called on the morning of 3/9/19. She said that left eye lid of her eye was drooping.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: Same as my wife, but no arm pain. Tired, headache, dizzy, fever of 101, body aches.
Age: 34.0
Sex: M
Vaccine: TYP
Symptoms: Abdominal pain upper, Chills, Headache, Nausea, Somnolence
Clinical narrative: I had light diarrhea the day after the 1st pill. I had chills, nausea, stomach pain, and headaches the day after the 2nd pill. I had to sleep all of the day after the 2nd pill. I still had the symptoms of the day after the 2nd pill on later days, but lessened.