chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Petechiae
Clinical narrative: This case was reported by a via call center representative and described the occurrence of petechial rash in a 57-year-old female patient who received SHINGRIX (batch number C523T, expiry date July 2020). The patient's past medical history included depression. Concurrent medical conditions included sulfonamide allergy (had extensive allergy history). Concomitant products included LEVAQUIN. On 9th April 2018, the received the 1st dose of SHINGRIX. In April 2018, less than a week after receiving SHINGRIX, the patient experienced petechial rash. On an unknown date, the outcome of the petechial rash was unknown. It was unknown if the reporter considered the petechial rash to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in her left arm. The pharmacist reported that the patient informed him today that she was experiencing a petechial rash which extends from the left side of her neck to her chest. The patient was on LEVAQUIN when she received SHINGRIX, and was not sure whether or not this was a reaction to the SHINGRIX or LEVAQUIN. The reporter stated that he recommended that the patient take BENADRYL, and was not aware of any medical intervention taken because of patients reaction. The reporter stated that patient had a history of depression and an extensive allergy history. At time of call however he was only able to report that she had a sulfa allergy and stated that he might have to call patient for more information. This case has been linked with case US2018063430 reported by same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of flu-like aching in a adult patient who received SHINGRIX (batch number YS53Y, expiry date January 2020). On 22nd March 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced flu-like aching. On an unknown date, the outcome of the flu-like aching was unknown. It was unknown if the reporter considered the flu-like aching to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The health care professional stated that after receiving SHINGRIX, his employee who was the patient reported general flu-like achiness. The health care professional reported a total of 4 adverse events during call. Did not obtain patient-specific information. The health care professional mentioned this in passing during the course of conversation. This case is 1 of the 4 linked cases reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Myalgia, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of fever in a female patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever, myalgia and fatigue. The patient was treated with TYLENOL and ibuprofen. On an unknown date, the outcome of the fever, myalgia and fatigue were recovered/resolved. The reporter considered the fever, myalgia and fatigue to be probably related to SHINGRIX. Additional information was reported as follows: The age at vaccination was not reported. The healthcare professional did not had any other patient demographic details or vaccine information. The events got resolved within 3 days. The healthcare professional called regarding a different patient's adverse event and happened to causally mention this particular patient and what he was told the events experienced by the patient.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Redness and swelling at injection site with hardness of the area x 1 week.
Age: 89.0
Sex: F
Vaccine: PNC13
Symptoms: Cellulitis, Injection site erythema, Injection site swelling, Rash
Clinical narrative: Patient said it started the following day after the shot and that there was a raised red area of site the size of a quarter. The rash progressed and got worse. Patient went to physician and it was diagnosed as cellulitis.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Arthralgia, Back pain, Fall, Gait inability, Hypoaesthesia
Clinical narrative: Lumbosacral radiculopathy L5 S1. Severe pain, muscle spasm, unable to walk. Use of crutches, walker, hospitalized. Use of narcotics and muscle relaxants. The patient is a 12-year-old female without significant past medical history seen here on February 5 for complaints of left low back pain. She reportedly had fallen to her knees while playing basketball on Saturday. Her pain started on Sunday and then she was seen here on that Monday. She had a urinalysis performed in the ER that was normal. She was given ibuprofen, NORCO, and VALIUM for her discomfort. She was discharged with prescription for VALIUM and Ibuprofen. On Wednesday she had an ultrasound of her kidneys which was normal. Since then she has seen her doctor and changed to cyclobenzaprine since VALIUM wasn't working. Today she has increased pain in the left SI joint with complaints of numbness in her left leg and inability to walk. No fever. No nausea, vomiting or diarrhea. She denies any incontinence or difficulty urinating. No saddle anesthesia.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Lumbosacral radiculopathy, Muscle spasms, Neurological examination, Nuclear magnetic resonance imaging, Pain
Clinical narrative: Lumbosacral radiculopathy L5 S1. Severe pain, muscle spasm, unable to walk. Use of crutches, walker, hospitalized. Use of narcotics and muscle relaxants. The patient is a 12-year-old female without significant past medical history seen here on February 5 for complaints of left low back pain. She reportedly had fallen to her knees while playing basketball on Saturday. Her pain started on Sunday and then she was seen here on that Monday. She had a urinalysis performed in the ER that was normal. She was given ibuprofen, NORCO, and VALIUM for her discomfort. She was discharged with prescription for VALIUM and Ibuprofen. On Wednesday she had an ultrasound of her kidneys which was normal. Since then she has seen her doctor and changed to cyclobenzaprine since VALIUM wasn't working. Today she has increased pain in the left SI joint with complaints of numbness in her left leg and inability to walk. No fever. No nausea, vomiting or diarrhea. She denies any incontinence or difficulty urinating. No saddle anesthesia.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Ultrasound kidney normal, Urine analysis normal, Walking aid user
Clinical narrative: Lumbosacral radiculopathy L5 S1. Severe pain, muscle spasm, unable to walk. Use of crutches, walker, hospitalized. Use of narcotics and muscle relaxants. The patient is a 12-year-old female without significant past medical history seen here on February 5 for complaints of left low back pain. She reportedly had fallen to her knees while playing basketball on Saturday. Her pain started on Sunday and then she was seen here on that Monday. She had a urinalysis performed in the ER that was normal. She was given ibuprofen, NORCO, and VALIUM for her discomfort. She was discharged with prescription for VALIUM and Ibuprofen. On Wednesday she had an ultrasound of her kidneys which was normal. Since then she has seen her doctor and changed to cyclobenzaprine since VALIUM wasn't working. Today she has increased pain in the left SI joint with complaints of numbness in her left leg and inability to walk. No fever. No nausea, vomiting or diarrhea. She denies any incontinence or difficulty urinating. No saddle anesthesia.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Fatigue, Hypersomnia, Injection site erythema, Injection site pain
Clinical narrative: Pt. came to pharmacy on 4/24/18 to report that she fell sick for 2 days: very weak, tired, slept a lot; painful at injection site = approximately 9/10; Red around vaccine site, swollen, but coming down.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Vaccination site swelling
Clinical narrative: Pt. came to pharmacy on 4/24/18 to report that she fell sick for 2 days: very weak, tired, slept a lot; painful at injection site = approximately 9/10; Red around vaccine site, swollen, but coming down.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Miliaria, Rash, Swelling
Clinical narrative: Severe fatigue (4/13). Severe fatigue (4/14). Rash (prickly heat, raised bump, extensive rash left side of body down into groin) (4/14/18). Still lingering on 4/24/18. Prescribed loratadine and prednisone.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Confusional state, Head discomfort, Pain, Pyrexia
Clinical narrative: Head swing, confuse, fever and pain.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Sleep disorder
Clinical narrative: Since receiving this shot I have had pain in my left arm at the injection site. For 2 months the pain was severe, waking me up at night. Now there is still pain, but it is manageable. I have been getting the flu shot for over 25 year and have never had an issue. This pain has lasted almost 4 months now.
Age: 1.25
Sex: M
Vaccine: MMR
Symptoms: Conjunctivitis, Culture negative, Decreased appetite, Diarrhoea, Fatigue
Clinical narrative: Full body rash. High fever. Diarrhea. Pink eye. Red throat. Loss of appetite. Fatigue. Believed to be measles.
Age: 1.25
Sex: M
Vaccine: MMR
Symptoms: Pharyngeal erythema, Pyrexia, Rash generalised, Streptococcus test negative
Clinical narrative: Full body rash. High fever. Diarrhea. Pink eye. Red throat. Loss of appetite. Fatigue. Believed to be measles.
Age: 28.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Pain, swelling in the area and warm to touch.
Age: 1.83
Sex: M
Vaccine: DTAP
Symptoms: Dermatitis allergic, Injection site rash, Rash
Clinical narrative: Rashes (allergy-like) came out from the patient's skin on tummy, right and leg thighs and legs and arms on the night of his vaccination day. Small visible marks appeared on his face. The doctor (who also administered the first booster shot of HiB), gave him Alnix (Cetirizine diHCL) drops 1.2 mL every 12 hours and Aerius syrup (Desloratadine) 2.5mL once a day, preferably lunch time. It was administered 3 days after the suspected adverse effect appeared. Until today, for 12 days of medication, allergy rashes are still appearing. The rashes will subside then appear again.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Muscle spasms, Neuralgia, Vaccination complication
Clinical narrative: Second shot is what caused side effects that were equal to my MS symptoms when diagnosed in 1998...extreme nerve pain and muscle spasms. I decided to have this vaccine since I had a mild case of shingles a couple of years ago and was told this was NOT a live virus. Further study needs to be done on any person with MS or any other neurological disease. I had the listed side effects but to the extreme along with spasms, etc.  I would not recommend to anyone who had a more severe case of MS. Should report to National MS Society. The first shot was mild but this second one is awful.  It will be interesting to see how long it takes to recover. Have contacted my physician with this information.  No follow up at this time but it is still early.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Arthritis, Injection site pain, Joint range of motion decreased, Ligament rupture, Musculoskeletal pain
Clinical narrative: Insidious onset no injury Initial bicep tendonitis, left shoulder pain, progressed to global shoulder pain and restricted range of motion with ulnar neuritis and sensory changes middle and posterior deltoid resulting in frozen shoulder decreased range of motion (active and passive) in all planes with pain.  MRI showed moderate joint inflammation, posterior inferior glenohumeral ligament rupture.  All tendons intact.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Nuclear magnetic resonance imaging abnormal, Periarthritis, Sensory disturbance, Tendonitis, Ulnar neuritis
Clinical narrative: Insidious onset no injury Initial bicep tendonitis, left shoulder pain, progressed to global shoulder pain and restricted range of motion with ulnar neuritis and sensory changes middle and posterior deltoid resulting in frozen shoulder decreased range of motion (active and passive) in all planes with pain.  MRI showed moderate joint inflammation, posterior inferior glenohumeral ligament rupture.  All tendons intact.
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Decreased eye contact, Gait inability, Investigation, Pyrexia, Social avoidant behaviour
Clinical narrative: Fever of 104, stopped walking for 6 days, stopped talking (babbling) for a year and 4mos, stopped socializing (eye contact, interactions of any kind).
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Speech disorder
Clinical narrative: Fever of 104, stopped walking for 6 days, stopped talking (babbling) for a year and 4mos, stopped socializing (eye contact, interactions of any kind).
Age: 19.0
Sex: M
Vaccine: ANTH
Symptoms: Pruritus, Skin mass
Clinical narrative: Subcutaneous nodule with pruritus, approximately 2cm.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site pain, Injection site swelling, X-ray limb normal
Clinical narrative: 22 hours post vaccination, parent noted the thigh was swollen. He complained of pain when it was touched. He continued to walk on it. Seen in the office. Right thigh was 1.5cm larger than his left. Xray of femor obtained and was negative for any concern with the bone. Advised mom warm compresses, ibuprofen, and soaking in warm bath. Patient to follow up in 2 weeks.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Diarrhoea, Headache, Myalgia, Nausea
Clinical narrative: Headache, Diaharrea, Chills, Fever, Nausea, Muscle pain for aprox. 12 hours. Headache and Muscle pain continuing (this is just the next day that I am reporting the reaction.)
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Headache, Diaharrea, Chills, Fever, Nausea, Muscle pain for aprox. 12 hours. Headache and Muscle pain continuing (this is just the next day that I am reporting the reaction.)
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Impaired work ability, Inflammation, Malaise, Pain
Clinical narrative: At 3 am following the vaccination, the patient woke up with severe unlocalized pain, general feeling of inflammation and malaise. The patients reaction was so severe she could not go to work or leave her bed from Wednesday until Friday. The patient says the symptoms she felt, felt similar to her lyme disease symptoms. The patient wanted to be clear that it was not an allergic reaction. It was a steady pain for 60 hours without any signs of allergy or anaphylaxis.
Sex: M
Vaccine: MMR
Symptoms: Antibody test negative
Clinical narrative: This spontaneous report was received from a pharmacist, referring to an adult male patient of unknown age. The patient's pertinent medical history and current medical conditions were not provided, neither information about any historical and concomitant medication taken by him, drug reactions or allergies. The pharmacist mentioned that during his childhood, on unspecified dates, the patient was vaccinated with the first and second dose of (wistar ra 27-3) M-M-R II for prophylaxis (route and anatomical site of administration, lot number and expiration date were not provided). It was reported that as an adult, on an unspecified date, the patient had an antibody titer drawn for measles, mumps and rubella, which resulted negative. Therefore, on an unspecified date, the patient was vaccinated with the third dose of (wistar ra 27-3) M-M-R II as part of a routine vaccination to get a new job (route and anatomical site of administration were not provided, lot number and expiration date were unknown by reporter). The pharmacist stated that after being vaccinated with the third dose of (wistar ra 27-3) M-M-R II the patient had, on an unspecified date, an antibody titer drawn for measles, mumps and rubella, which resulted to be negative. No treatment was given for the events and the patient did not seek medical attention. Further information was not provided. The outcome of measles, mumps and rubella antibody titers resulting negative was unknown by the time of reporting, and the pharmacist did not provide any causality assessment for them in regards with (wistar ra 27-3) M-M-R II vaccination.
Sex: F
Vaccine: PPV
Symptoms: Vaccination complication
Clinical narrative: This spontaneous report was received from a nurse via company representative regarding an elderly female patient over the age of 65 years. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date the patient was vaccinated with PNEUMOVAX 23 (lot#, expiration date, route of administration and dosing details were not reported) for prophylaxis. On an unknown date the patient experienced an unspecified severe reaction to PNEUMOVAX 23 (adverse event). The outcome of adverse event was unknown. Causality assessment was not provided by the reporter. This is one of the report received from the same reporter.
Age: 12.0
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report was received from a nurse who was also the patient's mother and refers to a currently 21 year old patient. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On an unspecified date in 2009, patient's approximate age 12 years, the patient was vaccinated with GARDASIL dose one for and on an unspecified date in 2010, was vaccinated with GARDASIL second dose (strength, route of administration, anatomical location, lot number and expiration date were not reported for any of the administered doses) both for prophylaxis. On an unspecified date in 2018, the patient was vaccinated with GARDASIL 9 dose one (strength, route of administration, anatomical location, lot number and expiration date were not reported) for prophylaxis as a third dose to finished the series. No adverse effects were reported. As of 23-APR-2018, an unspecified health care professional contacted during telephone follow-up could not supply information regarding this case. Additional information has been requested.
Sex: U
Vaccine: MMRV, RV5, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant refers to multiple unspecified patients of unknown age and gender. The patient's relevant medical history, concurrent condition and concomitant medication were not reported. No previous temperature excursion was reported. Concomitant therapy included properly stored DILUENT MRK INJ. On unspecified dates in 2018 (reported as from March-2018 to 20-APR-2018), the patients were vaccinated with improperly stored doses of (Oka-Merck) PROQUAD, therapy type: rHA, lot# N023969 (expiry date: 28-FEB-2019), (Oka/Merck) VARIVAX lot# N023960 (expiry date: 01-SEP-2019) and ROTATEQ lot# N012762 (expiry date: 04-FEB-2019) for prophylaxis (incorrect product storage). Temperature excursion of (Oka-Merck) PROQUAD and (Oka/Merck) VARIVAX was 6 degree Fahrenheit (F) to 14 degree F for 42 minutes whereas ROTATEQ was stored at or above 32 degree F up to 35 degree F for 52 minutes. ROTATEQ with same lot number in a different refrigerator was stored at or above 32 degree F up to 35 degree F for 3 hours and 48 minutes. Data logger was involved. No adverse effects reported. No product quality complaint (PQC) was involved.
Sex: M
Vaccine: PPV
Symptoms: Vaccination complication
Clinical narrative: This spontaneous report was received from a nurse via company representative regarding an elderly male patient over the age of 65 years. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date the patient was vaccinated with PNEUMOVAX 23 (lot#, expiration date, route of administration and dosing details were not reported) for prophylaxis. On an unknown date the patient experienced an unspecified severe reaction to PNEUMOVAX 23 (adverse event). The outcome of adverse event was unknown. Causality assessment was not provided by the reporter. This is one of the report received from the same reporter.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site reaction, Injection site scab, Injection site vesicles, Injection site warmth
Clinical narrative: Pt received his first SHINGRIX vaccine at 15:25 on 4/13/18 to his right deltoid. On 4/16/18 at 09:30 a 1.5cm x 1cm red area with a 0.5cm x 0.5cm clear blister was noted on his right deltoid. Below the blister was an area 5cm x 3cm of blotchy redness which was slightly warm to touch. Pt complained his arm was sore. On 4/17 there was a circular area with tiny blisters to the center with no open areas. On 4/19 the blisters were improving with no intervention. On 4/23 and 4/24/18 the area was scabbed and decreasing in size. No pain or open areas.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity, Rash macular
Clinical narrative: Pt received his first SHINGRIX vaccine at 15:25 on 4/13/18 to his right deltoid. On 4/16/18 at 09:30 a 1.5cm x 1cm red area with a 0.5cm x 0.5cm clear blister was noted on his right deltoid. Below the blister was an area 5cm x 3cm of blotchy redness which was slightly warm to touch. Pt complained his arm was sore. On 4/17 there was a circular area with tiny blisters to the center with no open areas. On 4/19 the blisters were improving with no intervention. On 4/23 and 4/24/18 the area was scabbed and decreasing in size. No pain or open areas.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Hallucination
Clinical narrative: He has had 2 episodes concerning for possible hallucination since HPV vaccination 2.5 months ago. It is not clear to me that this is true hallucination.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Pt. given IM injection in proper site. Site has become red, raised and puffy. Pt given diphenhydramine HS.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Fever 101 for 6-8 hours.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Extra dose administered, No adverse event, Wrong drug administered
Clinical narrative: Patient got  PREVNAR 13 on 04/05/2017 and another one on 04/17/2018. no adverse events reported by patient but got PREVNAR 13 instead of PNEUMOVAX 23 on 04/17/18.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV1
Symptoms: Chills, Crying, Grunting, Tremor
Clinical narrative: Mom called on 4-6-18 to report that after patient received shots on 4/5/18, around 2:30pm he started shivering, grunting, trembling and crying in his sleep. Had no fever and was better on 4-6-18. No injection site redness or swelling.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling
Clinical narrative: Localized swelling from injection site down to pt's elbow on inside of upper arm 6" wide x 7 1/4" long.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: No adverse event, Product preparation error
Clinical narrative: This spontaneous report was received from a physician regarding an 11 year old female patient. The patient's medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not provided. On 14-APR-2018, the patient was vaccinated with GARDASIL 9 (lot # M024261 with expiration date 30-JUL-2018) for prevention of cervical cancer, inadvertenly mixed with MENACTRA, lot # U5841AA with expiration date 08-MAR-2019 for an unknown indication (frequency and route were not provided). The patient received 0.5mL in "each deltoid" (wrong technique in product usage process). No treatment was given for the event. No adverse effects were reported.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Acoustic stimulation tests, Blood test, Deafness unilateral, Nuclear magnetic resonance imaging
Clinical narrative: This spontaneous report was received from a 62 year old male patient. The patient did not have pertinent medical history and drug reactions/allergies. Concomitant medications included an unspecified cholesterol medication. On 27-OCT-2014, the patient was vaccinated with ZOSTAVAX (lot # J016258, expiration date: not reported) (dose not specified) reconstituted with a sterile diluent subcutaneously to prevent shingles. On 01-NOV-2015, the patient experienced profound hearing loss in his left ear (Deafness unilateral). Lab diagnostics/studies performed included separate unspecified ear tests, Magnetic resonance imaging (MRI), and blood work ups and no results were provided. The patient was provided unspecified treatment for the adverse event. The patient sought medical attention by physician's office visit. The patient had not recovered and still had hearing loss in the left ear. The reporter did not assess the causality of the event with suspect therapy. Upon internal review, the event unilateral deafness was determined to be medically significant.
Age: 24.0
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Underdose
Clinical narrative: This spontaneous report was received from a medical assistant referring to a 24 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 10-APR-2018, the patient inadvertently received one pediatric dose of VAQTA Intramuscularly (dose, lot and expiry date not reported) (Drug administered to patient of inappropriate age). No adverse effect reported.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Blood test, Chills, Electrocardiogram, Feeling abnormal, Heart rate increased
Clinical narrative: Phone call from parent rec'd - "does not feel right". Increased heart rate and "severe shaking" all over - "teeth" are "knocking together" and unable to control the "shaking". Discussion with parent - to ER.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Tremor, Urine analysis, X-ray
Clinical narrative: Phone call from parent rec'd - "does not feel right". Increased heart rate and "severe shaking" all over - "teeth" are "knocking together" and unable to control the "shaking". Discussion with parent - to ER.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Redness/pain/warmth R triceps.
Age: 46.0
Sex: M
Vaccine: ANTH
Symptoms: Cellulitis, Pain in extremity
Clinical narrative: Pt went to the ER on 11 Apr 2018 for pain in the lt arm. Pt was diagnosed with cellulitis on the lt arm. Pt given Keflex for tx.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Fever and weakness for two days. Swelling and soreness where injected for 3 days.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR
Symptoms: Pyrexia, Rash generalised, Rhinorrhoea
Clinical narrative: Low grade fever, runny nose, full body rash.
Age: 53.0
Sex: F
Vaccine: MMRV
Symptoms: Drug prescribing error, No adverse event
Clinical narrative: Patient is a 53 year old going back to college and required a MMR booster since her measles and mumps injections were given to her prior to 1980. The physician had ordered a MMRV and the patient was given the MMRV. Patient had no reaction and did not need any additional treatment. The manufacturer for the MMRV was called and the patient must wait one month to receive a MMR if the provider feels she needs to get the MMR vaccine.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Skin warm, Tenderness
Clinical narrative: Patient first stated that on 4/22 she felt extremely fatigued and had to lie down all day. She states that the fatigue subsided by 4/23. Patient then stated that when she woke up on 4/25 she felt that her face was very warm and tender to the touch. She stated she could not put on her makeup as it felt too painful. She stated that it did not have the physical appearance of shingles outbreaks she has had in the past.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Chills, Constipation, Fatigue, Headache
Clinical narrative: Headache, chills, fever for 2 days, Nausea and unable to burp or pass gas, lingering for 4 weeks (still at this time) constipation. Fatigue, stomach ache, pain at injection site (went away in 5 days). Feeling of being "unwell". Still having episodes of fatigue, stomach ache & nausea despite following a limited diet (mostly liquids and soda to encourage burping.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Malaise, Nausea, Pyrexia
Clinical narrative: Headache, chills, fever for 2 days, Nausea and unable to burp or pass gas, lingering for 4 weeks (still at this time) constipation. Fatigue, stomach ache, pain at injection site (went away in 5 days). Feeling of being "unwell". Still having episodes of fatigue, stomach ache & nausea despite following a limited diet (mostly liquids and soda to encourage burping.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Blood test, Electroencephalogram, Extrapyramidal disorder, Seizure like phenomena, Urine analysis
Clinical narrative: Irregular seizure-like episode clusters, onset four days after administration of first round of live vaccines and continuing regularly for four days. Final diagnosis of paroxysmal spells, specifically shuddering attacks.
Age: 37.0
Sex: M
Vaccine: PNC13, TDAP
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site swelling
Clinical narrative: Immediate redness and swelling at injection site. Ice applied after reaction viewed by provider. Swelling and redness resolved within 20 minutes.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Feeling hot, Nausea, Syncope
Clinical narrative: She was feeling nausea and hot. She got up around 2 in the morning not feeling good. She got up from the bed and fainted in the kitchen.
Age: 23.0
Sex: F
Vaccine: HEPAB
Symptoms: Asthenia, Dizziness, Feeding disorder, Feeling abnormal, Impaired work ability
Clinical narrative: Almost immediately patient described feelings of dizziness and nausea. Within 5 minutes she was in the bathroom vomiting. After 20-30 minutes of rest in the breakroom she was still feeling ill and had to go home for the day and could not resume work. She reports not being able to eat for most of the day. No further treatment was needed and she was able to come back to work the next day, still feeling weak but able to complete her tasks.
Age: 23.0
Sex: F
Vaccine: HEPAB
Symptoms: Nausea, Vomiting
Clinical narrative: Almost immediately patient described feelings of dizziness and nausea. Within 5 minutes she was in the bathroom vomiting. After 20-30 minutes of rest in the breakroom she was still feeling ill and had to go home for the day and could not resume work. She reports not being able to eat for most of the day. No further treatment was needed and she was able to come back to work the next day, still feeling weak but able to complete her tasks.
Age: 11.0
Sex: M
Vaccine: HEPA, MNQ
Symptoms: Drooling, Erythema, Injection site erythema, Injection site pain, Irritability
Clinical narrative: MENACTRA and Hep A given on 4/23/18, 2 days ago- Last night seemed irritable and got MOTRIN, but no redness noted at that time - This morning in shower noticed significant redness on R upper arm; has decreased in size somewhat over the course of the morning today- No fever- Does feel hard and warm to touch but he does not wince in pain when it is touched. His nurse doesn't think he feels external pain so might not react even if the area was painful. She has been told he has a congenital indifference to pain externally. Has a mouth ulcer under his tongue; using magic mouthwash- Got botox injection under R chin yesterday; R cheek looks red today but has been drooling and rubbing his face a lot.
Age: 11.0
Sex: M
Vaccine: HEPA, MNQ
Symptoms: Mouth ulceration
Clinical narrative: MENACTRA and Hep A given on 4/23/18, 2 days ago- Last night seemed irritable and got MOTRIN, but no redness noted at that time - This morning in shower noticed significant redness on R upper arm; has decreased in size somewhat over the course of the morning today- No fever- Does feel hard and warm to touch but he does not wince in pain when it is touched. His nurse doesn't think he feels external pain so might not react even if the area was painful. She has been told he has a congenital indifference to pain externally. Has a mouth ulcer under his tongue; using magic mouthwash- Got botox injection under R chin yesterday; R cheek looks red today but has been drooling and rubbing his face a lot.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Vomiting
Clinical narrative: Threw up twice and felt nauseated all weekend.
Age: 22.0
Sex: F
Vaccine: HEPAB, MMR, VARCEL
Symptoms: Abortion spontaneous, Maternal exposure before pregnancy, Tuberculin test
Clinical narrative: Patient came in for vaccinations on 2/28/2018. Before administering vaccines I asked screening questions to ensure client did not have any contraindications to vaccine. She denied pregnancy and did not have any other contraindications. On 3/20/2018 patient spoke with another RN and informed her that she had just found out that she was pregnant. On 3/27/2018 I called and spoke with patient and she reported that she found out she was pregnant on the same day she talked to RN and that she did not know her due date yet but has a prenatal appt. scheduled for 3/30/2018. I told her I would follow up with her sometime after her appt. for more information.  On 4/25/2018 I called and spoke to patient and she informed me that she had lost the baby approximately 2 weeks ago. She reports that her estimated due date was going to be 11/30/2018 which would make her estimated conception date 3/9/2018. Client reports that this was her second pregnancy and she has not had any prior miscarriages. She reports that she was prepared to be pregnant but was not trying to get pregnant at time of vaccination, so the pregnancy was unexpected. She denies any questions or additional problems or concerns at this time. LSW, RN.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Fatigue, Headache, Injection site erythema, Injection site pain
Clinical narrative: Redness, pain and swelling at injection site. Headache, nausea diarrhea and fatigue.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Nausea
Clinical narrative: Redness, pain and swelling at injection site. Headache, nausea diarrhea and fatigue.
Sex: U
Vaccine: PPV
Symptoms: Adverse reaction
Clinical narrative: Initial unsolicited report received from nurse on 19-Apr-2018. This case is non-valid, as the type of reaction was not reported. This case involves two patients (age and gender not reported) who were vaccinated with a dose of PNEUMOVAX 23 (Batch number: N030111, expiration date, dose, route and site of administration was not reported) on an unspecified date. The patient's medical history and concomitant medications were not reported. On an unspecified date, post vaccination, the patient experienced significant reaction (unspecified). Lab data and corrective treatment were not reported. The outcome of the event was not reported. This case was considered as serious due to medically significant event. List of documents held by sender: none.
Sex: F
Vaccine: HPV9
Symptoms: Abnormal behaviour, Gait disturbance
Clinical narrative: This spontaneous report as received from a company representative refers to a 14-year-old female patient. There was no information about the patient's pertinent medical history, concomitant therapies or drug reactions and allergies provided. On 04-APR-2018, the patient was vaccinated with a second dose of GARDASIL 9, 0.5 ml, intramuscularly (lot# and expiration date were not provided), for prophylaxis. On 05-APR-2018, the patient was acting different than normal, walking differently, and exhibiting different characteristics. It was not specified which characteristics were different. Her mother took a video of the patients and was going to show the doctor during their appointment. No diagnostic test were performed. The outcome of the events was unknown. The causality assessment was not provided. This is one of two reports received from the same reporter concerning siblings.; Sender's Comments: US-009507513-1804USA010586:
Age: 47.0
Sex: U
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a 47 year old patient of unknown gender. The patient's concurrent conditions, medical history, drug reactions and allergies were not reported. Concomitant medication included STERILE DILUENT (lot# N021895 and expiration date: 29-NOV-2019). On 06-APR-2018 the patient was vaccinated with (Oka-Merck) PROQUAD therapy type rHA (0.5 ml, once) (lot # N019251 and expiration date: 20-DEC-2018) subcutaneously at the age of 47 years (product use issue). No adverse effects were reported. No product quality complaint was involved. "Lot number [N019251] has been verified to be a valid lot number for [measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live recombinant human albumin]."
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Vomiting
Clinical narrative: This spontaneous report was received from a pharmacist referring to a 13 year old male patient with asthma and an unspecified allergy treated with medication (no further details were provided); additionally, the patient had no drug reactions. On 19-APR-2018, the patient was vaccinated with the first dose of GARDASIL 9 for prophylaxis (strength, route, dosage schedule, lot number and expiration date were not reported). On 20-APR-2018, the patient vomited. The patient did not seek medical attention, no treatment was given for the adverse event and no laboratories or diagnostic tests were carried out. The outcome of vomiting was reported as recovered on an unspecified day in April 2018. Causality assessment was not provided.
Age: 1.58
Sex: U
Vaccine: HIBV
Symptoms: Product storage error
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a 19 month old patient. On 17-APR-2018, the patient was vaccinated with a dose of improperly stored LIQUID PEDVAXHIB(route unknown by reporter) lot # N034006 expiry date 01-FEB-2020 for prophylaxis (Product storage error). Temperature was reported as 9°C to 25°C. Time frame was reported as 1 hour and 15 minutes. There was no previous temperature excursion involved. The call was because of a data logger. No product quality complaint was involved.This is one of the three reports linked via same reporter link. Sender's Comments: US-009507513-1804USA010519: US-009507513-1804USA010520.
Age: 2.0
Sex: U
Vaccine: HIBV
Symptoms: Product storage error
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a currently 2 year old patient. On 19-APR-2018, the patient was vaccinated with a dose of improperly stored LIQUID PEDVAXHIB from lot N034006 expiry date 01-FEB-2020 for prophylaxis (Product storage error). Temperature was reported as 9°C to 25°C. Time frame was reported as 1 hour and 15 minutes. There was no previous temperature excursion involved. The call was because of a data logger. No product quality complaint was involved. This is one of the three reports linked via same reporter link. Sender's Comments: US-009507513-1804USA010520: US-009507513-1804USA010426.
Sex: F
Vaccine: DTAP, HPV9, MNQ
Symptoms: Abnormal behaviour, Gait disturbance
Clinical narrative: This spontaneous report as received from a company representative refers to a 11-year-old female patient. There was no information about the patient's pertinent medical history, concomitant therapies or drug reactions and allergies provided. On 04-APR-2018, the patient was vaccinated with a first dose of GARDASIL 9, 0.5 ml, intramuscularly (lot# and expiration date were not provided), for prophylaxis and with a dose of unspecified diphtheria toxoid, pertussis acellular vaccine (exact dose, frequency, route of administration, lot# and expiration date were not provided) for prophylaxis and with a dose of MENACTRA (exact dose, frequency, route of administration, lot# and expiration date were not provided) for prophylaxis. On 05-APR-2018, the patient was acting different than normal, walking differently, and exhibiting different characteristics. It was not specified which characteristics were different. Her mother took a video of the patients and was going to show the doctor during their appointment. No diagnostic test were performed. The outcome of the events was unknown. The causality assessment was not provided. This is one of two reports received from the same reporter concerning siblings. Sender's Comments: US-009507513-1804USA002912.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Abnormal dreams, Chills, Influenza like illness, Nausea
Clinical narrative: For the SECOND SHOT: Extreme soreness at vaccination site for 3 days: fully resolved in 6 days. Substantial shivering and chills at night for the first night; less the next night. Strange dreams the first two nights. Flu-like symptoms - light fever, nausea, overall body aches, stomach upset for first two days. Cold sores on lip for 7 days, beginning 3 days after vaccination. Off from work 2 days; full recovery in five days. NOTE: The first vaccine shot had only modest effects, mostly soreness.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Oral herpes, Pain, Pyrexia, Vaccination site pain
Clinical narrative: For the SECOND SHOT: Extreme soreness at vaccination site for 3 days: fully resolved in 6 days. Substantial shivering and chills at night for the first night; less the next night. Strange dreams the first two nights. Flu-like symptoms - light fever, nausea, overall body aches, stomach upset for first two days. Cold sores on lip for 7 days, beginning 3 days after vaccination. Off from work 2 days; full recovery in five days. NOTE: The first vaccine shot had only modest effects, mostly soreness.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Dysphagia, Eye swelling, Lip swelling, Mouth swelling
Clinical narrative: Patient received vaccine on 4/19 Thursday. Patient started getting a bubble or water blister under the eye approximately 24 hours after getting vaccine. Symptoms developed fast. Eyes and mouth/lips became swollen. It hurt to swallow and patient had difficulty swallowing. Patient went to ER administered cortisone shot and given oral BENADRYL with PEPCID. Gradual decrease in swelling. By 4/23 Monday all swelling disappeared. Patient is now fine.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Odynophagia
Clinical narrative: Patient received vaccine on 4/19 Thursday. Patient started getting a bubble or water blister under the eye approximately 24 hours after getting vaccine. Symptoms developed fast. Eyes and mouth/lips became swollen. It hurt to swallow and patient had difficulty swallowing. Patient went to ER administered cortisone shot and given oral BENADRYL with PEPCID. Gradual decrease in swelling. By 4/23 Monday all swelling disappeared. Patient is now fine.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Injection site pain, Myalgia
Clinical narrative: Severe headache, fever, chills, muscle aches, injection site pain, fatigue.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Severe headache, fever, chills, muscle aches, injection site pain, fatigue.
Age: 1.83
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Erythema with swelling around injection site. Induration of swelling measured to be 2.7in x 1.9in. Temp at 97.2 at 4:20pm on 04/20/18 during nursing visit. No warmth noted upon touch to site.
Age: 24.0
Sex: F
Vaccine: HEPA, TDAP, TYP
Symptoms: Herpes zoster
Clinical narrative: Developed shingles right arm about 10 days after. Is this a contraindication to repeat Hep A?
Age: 20.0
Sex: M
Vaccine: ADEN_4_7, FLUC4, MNQ, TDAP
Symptoms: Unevaluable event
Clinical narrative: See Note.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Fatigue, Neck pain, Pain, Pyrexia
Clinical narrative: The morning after having the shot I woke up achy and tired. I noticed my neck was especially painful. Within a couple of hours I knew I couldn't go to work, as I became feverish and extremely fatigued. I spent the day in bed, lacking the energy to do anything. Around 7:30 pm I felt well enough to get up and eat something but still weak and feverish. By the next morning I was able to go to work, but only felt about 80% back to normal. I have never responded to a vaccine this way, and it's making me reconsider getting the second shot.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Pyrexia
Clinical narrative: Postvaccination fever on 2018-04-23.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Vaccination complication
Clinical narrative: Adverse effect of vaccines and biological substances, init on 2018-04-22.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Severe body aches from neck, shoulders, back, legs, took ibuprofen with no results.
Age: 75.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Injection site cellulitis, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient received PNEUMOVAX around 10:30am and BOOSTRIX around 10:45am on 4/23. Patient had received the SHINGRIX vaccine (lot T5242) on 4/11 on the left arm about 11am. Patient had small bruise at injection site where SHINGRIX was given. Patient came back to pharmacy 4/24 around 10am to have pharmacist look at arm where she had received the PNEUMOVAX. The area was red and raised. The pharmacist marked the area with a pen and told patient to watch to see if area got bigger. Patient returned to pharmacy around 5pm to have it looked at again. The borders had increased about a half inch and was warm to touch and raised-area was (4x6 1/2). We consulted her to be evaluated by physician in case of cellulitis. The patient went to the walk in clinic where they did not give her diagnosis. They marked area with pen, gave her a steroid shot, and prescribed Cephalaxin 500mg bid. Patient came to pharmacy 4/25 around 10am to have area looked at. The redness and area of swelling had started to decrease from markings made by doctors office.
Age: 22.0
Sex: M
Vaccine: ADEN_4_7, FLUC4, HEPAB, MNQ, TDAP, VARCEL
Symptoms: Unevaluable event
Clinical narrative: See note.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Lymphadenopathy, Pain in extremity
Clinical narrative: Severe arm pain with swollen axilla Lymph node x 3 days. Headache x 2 days.