chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report was received from a nurse concerning a patient of unknown age and gender. The patient's historical conditions, concurrent conditions, concomitant therapies or allergies were not reported. On an unspecified date in 2010, at age 15, the patient was vaccinated with the first dose of GARDASIL (laterality, strength, dose, route, frequency, lot number and expiration date were not reported) for prophylaxis. On 02-OCT-2018, the nurse stated that the unspecified patient, currently 23 years old, received the second dose of GARDASIL 9 injection, reported lot number M044717, expiry date 19-JUL-2019, (laterality, strength, dose, route and frequency were not reported) for prophylaxis (Inappropriate schedule of drug administration), (Product use issue), (Product prescribing issue). No adverse effect was reported.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This case was reported by a pharmacist via out of hour services and described the occurrence of injection site erythema in a adult patient who received SHINGRIX (batch number A2JL7, expiry date 22nd March 2021) for prophylaxis. Concomitant products included SHINGRIX. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site erythema and injection site swelling. On an unknown date, the outcome of the injection site erythema and injection site swelling were unknown. It was unknown if the reporter considered the injection site erythema and injection site swelling to be related to SHINGRIX. Additional details were provided as follows: The case was reported by the registered pharmacist (Rph). The age at vaccination was not reported. The age group was not reported, but was selected adult as per vaccine indication. There was no redness or swelling for the patient after dose 1. The call was an AHVM (After Hours Voice Message) left by pharmacist on Sunday, 23rd September 2018 at 3:15 PM. On her message, she noted that GSK might contact the other pharmacist, who would be on duty the next day, 24th September 2018. A call back to the mentioned pharmacist was made, but there was no further information about the individual patients. This is 1 of the 5 cases, reported by the same reporter.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of rash herpetiform in a 81-year-old female patient who received SHINGRIX for prophylaxis. In September 2018, the patient received the 1st dose of SHINGRIX. In September 2018, 7 days after receiving SHINGRIX, the patient experienced rash herpetiform. The patient was treated with acyclovir. On an unknown date, the outcome of the rash herpetiform was unknown. It was unknown if the reporter considered the rash herpetiform to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on left arm. Approximately 1 week after receiving SHINGRIX, the patient experienced a rash on her back. The rash was located right above the armpit on the left side of the patient's back and looked similar to Shingles. On 21st September 2018, the patient was seen in the office by the doctor and received acyclovir for treatment. The nurse reported that she had pictures of available of the patient's rash if needed.
Age: 87.0
Sex: F
Vaccine: VARZOS
Symptoms: Apraxia, Cerebrovascular accident, Electroencephalogram abnormal, Gait disturbance, Muscular weakness
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of stroke in a 87-year-old female patient who received SHINGRIX (batch number A5X5B, expiry date 7th March 2021) for prophylaxis. On 20th September 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In September 2018, less than a week after receiving SHINGRIX, the patient experienced gaze apraxia (serious criteria GSK medically significant) and postictal state. On 24th September 2018, 4 days after receiving SHINGRIX, the patient experienced stroke (serious criteria hospitalization and GSK medically significant), lower extremities weakness of (serious criteria hospitalization) and abnormal gait (serious criteria hospitalization). The patient was treated with alteplase (Tpa (Tissue Plasminogen Activator)). On an unknown date, the outcome of the stroke, lower extremities weakness of and abnormal gait were recovering/resolving and the outcome of the gaze apraxia and postictal state were unknown. It was unknown if the reporter considered the stroke, lower extremities weakness of, abnormal gait, gaze apraxia and postictal state to be related to SHINGRIX. Additional details were provided as follows: At approximately 2:30 pm, the patient received SHINGRIX in the right deltoid. The physician reported that the patient was hospitalized at least overnight under a stroke protocol because of an acute event several days after receiving the SHINGRIX vaccine. The patient started walking towards her right side and she experienced weakness in her legs. The healthcare professional thought she had a stroke so they administered TPA and the patient developed a gaze preference and they did a magnetic resonance imaging (MRI) and the MRI was negative and the electroencephalography (EEG) showed some changes but nothing specific. The tests might indicate a post seizure state. The patient was much better on the day of reporting. The patient had no recent infections and no change in medications.
Age: 87.0
Sex: F
Vaccine: VARZOS
Symptoms: Nuclear magnetic resonance imaging normal, Postictal state
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of stroke in a 87-year-old female patient who received SHINGRIX (batch number A5X5B, expiry date 7th March 2021) for prophylaxis. On 20th September 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In September 2018, less than a week after receiving SHINGRIX, the patient experienced gaze apraxia (serious criteria GSK medically significant) and postictal state. On 24th September 2018, 4 days after receiving SHINGRIX, the patient experienced stroke (serious criteria hospitalization and GSK medically significant), lower extremities weakness of (serious criteria hospitalization) and abnormal gait (serious criteria hospitalization). The patient was treated with alteplase (Tpa (Tissue Plasminogen Activator)). On an unknown date, the outcome of the stroke, lower extremities weakness of and abnormal gait were recovering/resolving and the outcome of the gaze apraxia and postictal state were unknown. It was unknown if the reporter considered the stroke, lower extremities weakness of, abnormal gait, gaze apraxia and postictal state to be related to SHINGRIX. Additional details were provided as follows: At approximately 2:30 pm, the patient received SHINGRIX in the right deltoid. The physician reported that the patient was hospitalized at least overnight under a stroke protocol because of an acute event several days after receiving the SHINGRIX vaccine. The patient started walking towards her right side and she experienced weakness in her legs. The healthcare professional thought she had a stroke so they administered TPA and the patient developed a gaze preference and they did a magnetic resonance imaging (MRI) and the MRI was negative and the electroencephalography (EEG) showed some changes but nothing specific. The tests might indicate a post seizure state. The patient was much better on the day of reporting. The patient had no recent infections and no change in medications.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of injection site pain in an unspecified number of adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patients received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patients experienced injection site pain and injection site swelling. On an unknown date, the outcome of the injection site pain was recovered/resolved and the outcome of the injection site swelling was unknown. It was unknown if the reporter considered the injection site pain and injection site swelling to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not applicable for this report. The age group was not reported but was captured as adult as per vaccine indication. The reporter mentioned on phone call that, another pharmacist asked about pain incidence associated with a dose of SHINGRIX. The reporter mentioned that, several people said the vaccine really hurt and the pain did not go away until a few days after the vaccination, some advised up to a week. The reporter did not have details as to who the patients were and who experienced the pain at injection site and could not provide any more details. The sales representative attempted to get more information but he did not have anything to add. The reporter was advised, in the future he needed to get specific information and provide the details to GlaxoSmithKline (GSK), for which the reporter said he would. It was stated that, all patients were over 50 years of age and some were men and some were women. The reporter did not agree to follow up.
Sex: M
Vaccine: FLUX
Symptoms: Neurological symptom
Clinical narrative: Initial information received from literature on 27-Sep-2018. Abstract: Serious adverse events after immunizations are rare. We review the case of a man who, 50 years earlier, experienced a serious adverse neurologic event 2 weeks after receiving influenza vaccine. He had received no subsequent seasonal influenza vaccinations, but after the risks and benefits were considered, he was vaccinated without adverse event that season. This case involves a male patient (age not reported) who experienced adverse neurologic event, while he received vaccine INFLUENZA VACCINE. The patient's past medical history and concomitant medication were not reported. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported. On an unknown date (reported as 50 years earlier), The patient developed a serious adverse neurologic event (neurological symptom) 2 weeks following the administration of INFLUENZA VACCINE. This event was assessed as medically significant. The patient had received no subsequent seasonal influenza vaccinations, but after the risks and benefits were considered, he was vaccinated without adverse event that season. No lab tests reported. Final diagnosis was adverse neurologic event. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for adverse neurologic event.; Sender's Comments: This literature article describes a patient of unknown age who experienced unspecified neurologic event post vaccination with INFLUENZA VACCINE produced by unknown manufacturer. Time to onset is unknown. Additional information including patient's medical history, condition at the time of vaccination, vaccine and reaction details, lab/radiological test ruling out alternate etiologies especially neurological are needed for complete assessment of the case. Based on available information the role of vaccine cannot be assessed.
Sex: M
Vaccine: FLU3, PNC13
Symptoms: No adverse event, Syringe issue, Underdose
Clinical narrative: Initial information received on 27-Sep-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 74 years old male patient and reported that the vaccine seemed to leak at the bottom where the needle attaches and the suspect vaccine was FLUZONE HIGH DOSE. Concomitant medications included PREVENAR 13. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 27-Sep-2018, the patient received a 0.5 ml dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (lot number: UJ023AA) (expiry date, dose in series, route and site of administration was not reported). It was a case of actual medication error due to underdose. No adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Syringe issue, Underdose
Clinical narrative: Initial unsolicited report received from pharmacist on 28-Sep-2018. This case involves a [69 years old] male patient who was vaccinated with a 0.5 ml dose of FLUZONE HIGH DOSE (Batch number: UJ024AA, expiration date: 29-APR-2019 and site of administration: left deltoid and route was not reported) on 28-Sep-2018. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to syringe issue (needle seemed loose, quite a bit of the immunization leaked out on the patient's arm and leaked out of where the needle attaches to the syringe). It was unknown whether patient experienced any adverse event following vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain
Clinical narrative: I spoke to the patient, she said that the vaccine did not hurt that much on injection, but lter that day and for the next couple of days, it hurt alot. Her arm still hurts, but is in an ache at certain times. Last night, it really hurt a lot and throbbed all night. It kept her awake.
Age: 63.0
Sex: F
Vaccine: TDAP
Symptoms: Neuropathy peripheral
Clinical narrative: LEFT BRACHIAL NEUROPATHY.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Anti-cyclic citrullinated peptide antibody positive, Arthritis, C-reactive protein increased, Red blood cell sedimentation rate increased, Rheumatoid arthritis
Clinical narrative: Patient had started noticing right hand PIP tenderness in the 4 weeks prior to the vaccine. Within 4 weeks after the vaccine he had developed bilateral, polyarticular inflammatory arthritis and diagnosed with Rheumatoid Arthritis.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Rheumatoid factor positive
Clinical narrative: Patient had started noticing right hand PIP tenderness in the 4 weeks prior to the vaccine. Within 4 weeks after the vaccine he had developed bilateral, polyarticular inflammatory arthritis and diagnosed with Rheumatoid Arthritis.
Age: 70.0
Sex: M
Vaccine: FLUR4
Symptoms: Arthralgia, Chills, Myalgia, Nausea, Pyrexia
Clinical narrative: Fever 101, muscle joint aches, chills, nausea lasted 5 days.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Left arm is red, warm, swollen just slightly lower than the injection site.
Age: 29.0
Sex: F
Vaccine: FLU4
Symptoms: Abdominal discomfort, Blood glucose increased, Dizziness, Posture abnormal, Visual impairment
Clinical narrative: On 10/2/18 at approximately 1:30 PM, I administered a flu vaccine per protocol to patient at employee/spouse clinic. Since it was her first flu vaccine, I asked her to stay for a 15 minute observation in the event of any untoward reaction to the vaccine. After 10 minutes elapsed, patient complained of dizziness, lightheadedness and visual disturbances. She was fully oriented, heart rate was palpable and approximately 70, she answered questions appropriately and was not experiencing difficulty breathing. Her eyes closed and she had difficulty sitting up and supporting her head. 911 was called for assistance. I moved her to a supine position which helped somewhat, but she still complained of the above symptoms although they were less severe. In addition, she started complaining of lower abdominal discomfort. Vital signs before EMTs arrived were 86/54, 78 and 20. After EMTs arrived, her vital signs continued to be on the low side. Blood glucose was 129. The decision was made to transport her to the ER for further evaluation. Her husband had been called and arrived to accompany her in the ambulance which departed at approximately 2PM.
Age: 8.0
Sex: F
Vaccine: FLU4
Symptoms: Body temperature increased, Headache, Injection site pruritus, Injection site pustule, Injection site rash
Clinical narrative: On 10/3/18 patient woke up complaining of itchy rash at injection site, she also had elevated temp at 99.3 and headache reported by school nurse. The rash continued to get worse with significant redness and swelling along the entire upper arm. The rash looked pustular in nature and is currently being treated with topical diphenhydramine, she was given ibuprofen for the headache and temp. Since reaction has not yet resolved, outcome and time course still to be determined.
Age: 8.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site swelling
Clinical narrative: On 10/3/18 patient woke up complaining of itchy rash at injection site, she also had elevated temp at 99.3 and headache reported by school nurse. The rash continued to get worse with significant redness and swelling along the entire upper arm. The rash looked pustular in nature and is currently being treated with topical diphenhydramine, she was given ibuprofen for the headache and temp. Since reaction has not yet resolved, outcome and time course still to be determined.
Age: 1.5
Sex: M
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: Pt did not have any symptoms, signs. We notice the expiration date when charting.
Age: 47.0
Sex: M
Vaccine: FLU4
Symptoms: Arthralgia, Malaise, Peripheral swelling, Swelling face
Clinical narrative: Patient reported "not feeling well" at 6 pm. Then swelling to face, neck, hands, legs, feet. Denies difficulty breathing. Denies fever. Patient is a security gaurd for the hospital and left the facility without seeing the ER physician. Traveled home and took benadryl 50mg and soaked body in ice water. Then contacted the employee health nurse who administered the vaccine. He was encouraged to go to ER, but refused stating the swelling was gone and he felt better. Follow up call the next day revealed joint aching, sorness, but no swelling, difficutly breathing, rash, or fever. Encouraged to be seen in ER, refused.
Age: 75.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Nausea
Clinical narrative: Moderate swelling, redness and pain at the site of injection. Pt reported nausea as well. Pt was given IM solumedrol 125 mg x 1, was advised to apply ice to area and take Benadryl every 4-6 hrs. She was subsequently started on a Medrol dose pack and zantac as well.
Age: 72.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient reports over the last 2-3 days had increased pain and swelling and redness about the left proximal arm. No fever chills. No malaise. No numbness tingling or focal weakness. No rash otherwise. Just continues to have redness with swelling at this time. States its going on 6 days.
Age: 64.0
Sex: F
Vaccine: MMR
Symptoms: Full blood count, Pruritus, Rash generalised
Clinical narrative: Woke up on the 2nd with a full body rash and on arms and part of the thighs and legs. Mild itching in places and in the scalp. Clinician checked back and said some spots were there also. No treatment except told to take prednisone (2.5mg) for the itching. Told to go home from work. On the 3rd rash was lighter not itchy, took prednisone but then later in the day took BENADRYL rested for the day. On the 4th got up rash was light, took prednisone just on case reported to Employee Health. Rash had gotten slightly darker so was going to be sent home. Fact sheet for MMR said with this rash platelets could be affected so I insisted on a blood test to check. Blood take but sent home to wait for results.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Urticaria
Clinical narrative: Patient received vaccine at 615am, around 7am pt started to have itching and had hives/welts develop on her face-lips, eyelid, arms and legs. Took Benadryl and it went away. Came back the next day in the afternoon so patient went to ER. Was given oral prednisone and advised to take Benadryl as well and follow up if symptoms come back.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Discomfort, Mobility decreased, Pain
Clinical narrative: AT 4PM FELT SOME DISCOMFORT, BY 6 PM IN INTENSE PAIN AND COULD NOT MOVE ARM, WENT TO EMERGENY ROOM AT HOSPITAL AND WAS SEEN BY MD.
Age: 23.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Full blood count, Nausea, Vomiting
Clinical narrative: Associate became light headed, nauseated/vomited 20 minutes after receiving flu vaccine.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal discomfort, Asthenia, Back pain, Decreased appetite, Fatigue
Clinical narrative: Extreme fatigue, weakness, slept 14 hours in a 20 hour period, aching...especially lower back above waistline both sides. Upset stomach, no appetite. Headache. Fever. All over serious illness, felt like I'd been hit by a train.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Malaise, Pyrexia
Clinical narrative: Extreme fatigue, weakness, slept 14 hours in a 20 hour period, aching...especially lower back above waistline both sides. Upset stomach, no appetite. Headache. Fever. All over serious illness, felt like I'd been hit by a train.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Injection site pain, Myalgia
Clinical narrative: Pain at injection site, Strong Fatigue, Muscle soreness throughout body.
Age: 42.0
Sex: F
Vaccine: FLUR4
Symptoms: Blood test, Cough, Dyspnoea, Headache, Injection site pruritus
Clinical narrative: Employee Received FLUBLOK QUAD at 8:45 am IM in R Deltoid, by 9:08 she began itching her upper R arm, then L arm, then L lower leg. Employee Health Nurse instructed to go to ER. Another Employee Health Nurse walked her downstairs to the ER, where she began to have continuous clearing of throat, some coughing. Before arriving downstairs at ER, patient began to have shortness of breath and nausea. Patient arrived at ER with itching, shortness of breath, headache and nausea.
Age: 42.0
Sex: F
Vaccine: FLUR4
Symptoms: Nausea, Pruritus, Throat irritation
Clinical narrative: Employee Received FLUBLOK QUAD at 8:45 am IM in R Deltoid, by 9:08 she began itching her upper R arm, then L arm, then L lower leg. Employee Health Nurse instructed to go to ER. Another Employee Health Nurse walked her downstairs to the ER, where she began to have continuous clearing of throat, some coughing. Before arriving downstairs at ER, patient began to have shortness of breath and nausea. Patient arrived at ER with itching, shortness of breath, headache and nausea.
Sex: M
Vaccine: HPV9
Symptoms: Dizziness, Feeling abnormal, Immediate post-injection reaction, Pallor
Clinical narrative: Information has been received from a physician referring to a 17 year old male patient. The patient's concurrent condition, concomitant medication and medical history were not provided. On an unknown date the patient was vaccinated with the first dose of GARDASIL 9 (strength, dose, frequency, route, lot #, expiration date and indication were not provided). On an unknown date, the patient complained of "not feeling good, was pale and very dizzy, and had to lie down" immediately after receiving the first dose of GARDASIL 9. The outcome of the events was reported as recovered/resolved. The causality assessment was not provided. No product quality compliance involved. This is one of the same report (reported as: different patient, who was also patient's sibling) received from the same reporter.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Syringe issue, Underdose
Clinical narrative: This spontaneous report was received from a nurse via a company representative, and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 10-SEP-2018, the patient was vaccinated with GARDASIL 9 (dose and route of administration not provided, lot # N035955, expiration date 09-OCT-2020), and an approximately half of the dose leaked out around the syringe tip and resulted in patient receiving partial dose. No adverse effect was reported.
Sex: U
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Arthritis allergic, Dyschezia, Infantile spitting up, Irritability
Clinical narrative: This spontaneous report was received from a nurse via field representative and refers to a 10-weeks-old patient. The patient had an allergy to corn. There was no information about the patient's pertinent medical history provided. On an unknown date in 2018, the patient was vaccinated with PEDVAXHIB lot # R004962, expiration date 20-NOV-2020 (dose, route of administration and frequency were not reported) for prophylaxis and ROTATEQ, orally, lot # R002515, expiration date 13-SEP-2019 (dose and frequency were not reported) for prophylaxis. On the same day, the patient was also vaccinated with PREVNAR and PEDIARIX (doses, routes of administration, lot numbers and expiration dates were unspecified), both for prophylaxis. On 14-AUG-2018, the patient became very fussy, was spitting up and was struggling to poop. The nurse also reported that it was suspected that it might have been an allergy to a corn byproduct as sorbate was a corn derivative and it was in ROTATEQ. The outcome of the events was unknown. The relatedness between irritability, infantile spitting up, dyschezia and the suspect therapies was not reported. The reporter considered drug hypersensitivity to be related to ROTATEQ.
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Eye burns, Eye swelling, Ocular hyperaemia
Clinical narrative: Eye Swelling, Eye Redness, Eye Burning.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Cold sweat, Headache, Injection site pain, Injection site swelling
Clinical narrative: Pain and swelling at injection site, cold sweats, shivering, headaches, lethargy.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Lethargy
Clinical narrative: Pain and swelling at injection site, cold sweats, shivering, headaches, lethargy.
Age: 1.58
Sex: F
Vaccine: DTAP
Symptoms: Cyst, Erythema, Pyrexia, Screaming
Clinical narrative: Bright red, thrashing and screaming, fever, large cyst like spots all over her body.
Age: 21.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Muscular weakness, Pain in extremity
Clinical narrative: Patient called on 10/3/2018 complaining of weakness and pain in arm. Unable to lift arm very well. Said she thought shot may have been given too high.
Age: 74.0
Sex: F
Vaccine: FLUA3
Symptoms: Dyspnoea, Flushing, Nasal congestion
Clinical narrative: Difficulty breathing through her nose, feels like her nose is swelling, cheeks flushed.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Pain and swelling of leg, warm to touch, redness. Advise to continue ICE, and ibuprofen for pain. If worsening f/u, if any fevers f/u immediately.
Age: 74.0
Sex: F
Vaccine: FLUA3
Symptoms: Rash erythematous
Clinical narrative: Large red rash on left side of the arm.
Age: 22.0
Sex: F
Vaccine: FLU4
Symptoms: Syncope
Clinical narrative: Employee was given a Flu vaccine and PPD shortly after. Syncopal episode after PPD skin test was given.
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Patient came to the pharmacy 2 days after receiving the vaccine, her arm was red, hot to the touch, and swollen. She did not have a fever, however states "she never gets a fever with infection."
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Wrong technique in product usage process
Clinical narrative: DTaP-IPV component of PENTACEL administered IM R. thigh then PENTACEL (Diphtheria, Tetanus Toxoids + Acellular Pertussis Adsorbed Inactivated Polio virus + hemophilus B conjugate) administered R thigh due to DTaP-IPV component only being invalid at time of visit. After immunizing patient with PENTACEL we realized that dose of DTaP-IPV component is a valid dose for DTaP-IPV. Patient should of received HIB dose to complete series but instead received a dose of PENTACEL at same visit.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Patient presents today for point of care (walkin) f/u due to potential vaccine reaction. C/o: erythema and hardening of skin to LEFT deltoid that began one day after SHINGRIX injection on 9/6/18. Objective: Verified ss/name, decline chaperone. 71yo male. Dressed appropriately, resting comfortably in exam room. Speaking in clear, full sentences. Has full mobility without gait abnormalities or assistive devices. Skin to left deltoid warm, dry, intact, erythematic (which he says is improved). Erythema measures 8.5cm x 9cm. Denies any prior vaccine reaction, itching, swelling, myalgia, fatigue, headache, fever. 09/10/2018 Addendum Status: Completed Seen patient. Left shoulder erythema at injection site for SHINGRIX vaccination about 5 days prior. He has noted regression of the erythema. On exam aprox 4cm area of erythema, warm to touch, no fluctuance. Treating as possible cellulitis. Ordered cephalexin.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Erythema, Skin warm
Clinical narrative: Within 24 hours of injection erythema was noted. Area of erythema spread became irregular in shape and warm to touch.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Full blood count, Influenza, Lipids, Metabolic function test, Myalgia
Clinical narrative: Generalized myalgias, worse in legs. Flu symptoms x4 days. Myalgias persisted x 4 weeks.
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Injection site turned red, the skin is lifted, warm to the touch and it is painful.
Age: 60.0
Sex: F
Vaccine: FLU4, PPV, TDAP
Symptoms: Hypoaesthesia, Injection site erythema, Injection site induration, Pyrexia
Clinical narrative: The Flu vaccine was the one administrated in the area that had the reaction. The day after the administration during the afternoon she had fever, she felt her legs with a type of numbness and the area was red. Thursday the area was hard and red, she visited the Dr. to his office and he administered SOLU-MEDROL and hydrocortisone cream. She came to the pharmacy on Friday to inform the event. Pharmacist called patient 09/30/2018 9:20 am and confirmed that she already recovered.
Age: 19.0
Sex: F
Vaccine: FLU4
Symptoms: Chest pain, Dyspnoea, Erythema, Peripheral swelling
Clinical narrative: Redness, swelling of arm, chest pain and shortness of breath.
Age: 61.0
Sex: M
Vaccine: FLU4
Symptoms: Blepharospasm, Blood pressure increased, Facial paralysis
Clinical narrative: Patient started with right sided lower facial nerve palsy (bells palsy), eye twitching, elevated BP.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Pain, Pyrexia
Clinical narrative: Day after flu shot, fever of 101.5, aches, weakness. 2nd day fever of 100, weakness.
Age: 32.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pruritus, Injection site warmth
Clinical narrative: Right deltoid warm to touch, itchy to patient, roughly 4 inch delineated circle around injection site, with bandaid residue still seen. No discharge. BENADRYL Allergy Tablet, 25 MG, 1 tablet as needed, Orally, every 8 hrs, Hydrocortisone Cream, 1 %, 1 application to affected area, Externally, Twice a day.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash erythematous
Clinical narrative: Itch occurred almost immediately, red rash appeared on shoulder & down the arm, gradually disappeared over a couple of weeks.
Age: 20.0
Sex: F
Vaccine: FLU4
Symptoms: Exposure during pregnancy, Injection site pain, Injection site rash, Injection site vesicles
Clinical narrative: G1 P0 @ 20.5weeks with c/o blister, rash and pain on left arm at injection since yesterday S/P Flu Vaccine, family at side for support. Patient reports having Flu Vaccine in the past without any problems. PO BENADRYL 25mg given with directions to take TID PRN itching.
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Headache, Photophobia, Vomiting
Clinical narrative: The next day after vaccination, employee awoke with a headache at 07:45 A.M. She took Ibuprofen 800 mg when she got home @ 8:25. Afterwards she laid down because of the headache. Around 2:00 P.M. she took 440 mg of Naproxen. Around 4:00 P.M. she back to bed and slept some more. At 8:15 P.M. she took Ibuprofen 800mg again. She slept all night. The headache has not gone away since it started. She has continued to take Ibuprofen & Naproxen. On 10-3-18 she call Employee Health about the headaches after talking to her supervisor that referred her to Employee Health. I suggested to her to take BENADRYL 50 mg now and then at bedtime. She called this morning 10-4-18 and she still had the headache. While I was filling out the report she took EXCEDRIN 2 tabs (500 mg TYLENOL/500 mg ASA). At times it is worse than others. She has had light sensitivity & has had vomiting x 2 on the second day.
Age: 13.0
Sex: F
Vaccine: FLU4
Symptoms: Electrocardiogram, Nausea, Seizure like phenomena
Clinical narrative: Flu Vaccine given at approximately 10:47 without concern or incident at time of injection. After leaving the office child complained of nausea and mom noted what looked like seizure like activity in the back seat. Returned to office Child examined in the car by PNP, she was responsive with even non-labored respirations. Vital signs checked BP was 87/58 pulse 56 oxygen saturation 100% Grips were equal  pupils were equal and reactive to light. Patient alert and oriented prior to being transported to ER via ambulance for further evaluation.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site induration, Injection site pain, Pain
Clinical narrative: Arm hurt in the muscle around the injection site and arm felt hard for 4 days. I also felt achy and tired for about 4 days. I didn't need to take any pain relievers however.
Age: 65.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Diarrhoea, Vaccine positive rechallenge, Vomiting
Clinical narrative: Diarrhea and vomiting.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Pollakiuria, Seizure like phenomena, Tremor
Clinical narrative: Patient woke up around 1 am with extreme chills and shivering to the point where he could not control his shaking. He felt that the shaking was similar to convulsion like movements. He also had to urinate 8 times that night.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dehydration, Dizziness, Hypotension, Insomnia
Clinical narrative: Starting about 11pm the day of receiving the 2nd Shringrix vaccine, began to experience excessive urination that continued for 8 hours overnight. Could not sleep, partly due to the expected muscle aches & chills, but also the need to get up & urinate. On Oct 3, excessively dehydrated with dizziness & low Blood pressure. Realizing the problem - drank large amounts of fluid to rehydrate -- and found I did not have a return to normal urinary patterns until about 6pm Oct 3 -- meaning I did not urinate much during that day, but have been normal for about 12 hrs at this time. Muscle aches & fever has subsided. My main reason for reporting this side effect is that I found no mention of excessive urination on any of the websites I consult for side effects from medications.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Pollakiuria
Clinical narrative: Starting about 11pm the day of receiving the 2nd Shringrix vaccine, began to experience excessive urination that continued for 8 hours overnight. Could not sleep, partly due to the expected muscle aches & chills, but also the need to get up & urinate. On Oct 3, excessively dehydrated with dizziness & low Blood pressure. Realizing the problem - drank large amounts of fluid to rehydrate -- and found I did not have a return to normal urinary patterns until about 6pm Oct 3 -- meaning I did not urinate much during that day, but have been normal for about 12 hrs at this time. Muscle aches & fever has subsided. My main reason for reporting this side effect is that I found no mention of excessive urination on any of the websites I consult for side effects from medications.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Mobility decreased, Musculoskeletal pain
Clinical narrative: Has shoulder pain afterward and couldn't lift arm the next day, able to lift arm now but still has pain in the shoulder area.
Age: 79.0
Sex: F
Vaccine: HEPA
Symptoms: Feeling jittery, Urticaria
Clinical narrative: Hives and jitteriness reported that evening after receiving vaccine (4-5 hours later).
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a consumer refers to nine patients of unknown ages and genders. The patients historical conditions, concomitant medications and drug reactions or allergies were not reported. In 2018 (reported as in the last 3 months), one patient was vaccinated with an improperly stored dose of VARIVAX for prophylaxis, lot # N020016 and an expiration date 17-JUL-2019; however, route, dosage schedule, anatomical location and dosage number were not reported. In 2018 (reported as in the last 3 months), eight patients were vaccinated with PROQUAD recombinant Human albumin (RHA) for prophylaxis, lot # N035172 and an expiration date 09-JUN-2019; however, route, dosage schedule, anatomical location and dosage number were not reported. On 29-JUN-2018, an unspecified number of patients were vaccinated with an improperly stored dose of PROQUAD (RHA) lot number N025718 with an expiration date of 17-MAR-2019, which experience excursion the following dates: on 28-JUN-2018, the excursion was 9.10°F for 0.5 hours; on 29-JUN-2018, the excursion was 9.50°F for 0.5 hours; and on 30-JUN-2018, the excursion was 8.80°F for 1.75 hours (conflicting information). On 31-JUL-2018, an unspecified number of patients were vaccinated with an improperly stored dose of PROQUAD (RHA) lot number N025718 with an expiration date of 17-MAR-2019, which experience excursion the following dates: on 30-JUL-2018, the excursion was 8.10°F for 0.25 hours; and on 31-JUL-2018, the excursion was 7.30°F for 0.25 hours. Additionally, on 31-AUG-2018, an unspecified number of patients were vaccinated with an improperly stored dose of PROQUAD(RHA) lot number N035172 with an expiration date of 09-JUN-2019, which experience excursion on 07-AUG-2018, the excursion was 17.10°F for 3.25 hours. The reporter stated there were previous temperature excursions. The call was placed because of a Digital Data logger.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Product storage error
Clinical narrative: This non-valid spontaneous report was received from a medical assistant and refers to an unknown number of patients of unknown age and gender. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD, recombinant human albumin (rHA), lot # N028445, expiration date 09-APR-2019 (reported as 19-APR-2019) and VARIVAX, lot # N022981, expiration date 23-AUG-2019; for prophylaxis (strength, dose, frequency and route of administration of the vaccines were not reported). The vaccines were stored in temperature range between -14 and -10 degrees Celsius for 31 hours (date not reported). There was no previous temperature excursion reported. A digital data logger was involved.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site rash
Clinical narrative: ZOSTAVAX given 5/24, rash at injection site appeared 5/28 about 10cm in diameter, red, itching, now resolving. No longer itching, about 2-3cm in diameter on 5/31.
Age: 66.0
Sex: F
Vaccine: FLUR4
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Redness, swelling and itchiness at and surrounding the injection site. Warm to touch.
Age: 78.0
Sex: M
Vaccine: FLU3
Symptoms: Nausea, Vomiting
Clinical narrative: Nausea Vomiting.
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia, Injection site hypoaesthesia, Injection site paraesthesia, Paraesthesia
Clinical narrative: Patient reported within 30-45mins of vaccination that she noticed tingling/numbing sensation that was presented from site of injections down to her fingers on her right arm. She described it as "her arm filled asleep". No other symptoms reported. Nurse on staff recommended her to take some ibuprofen and cold compress for 20 mins.
Age: 33.0
Sex: F
Vaccine: FLUR4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness/swelling below injection site. Tx with intermittent ice, ZYRTEC and ibuprofen PRN.
Age: 73.0
Sex: F
Vaccine: FLUA3, VARZOS
Symptoms: Body temperature increased, Chills, Dizziness, Hyperhidrosis, Nausea
Clinical narrative: Pt received both vaccines around 11am on 10/1/18. Around 2pm she felt chills, sleepy, achy, temp of 101, dizzy, sweaty, and a little nauseous. As of 10/4/18 Patient is feeling much better.
Age: 73.0
Sex: F
Vaccine: FLUA3, VARZOS
Symptoms: Pain, Somnolence
Clinical narrative: Pt received both vaccines around 11am on 10/1/18. Around 2pm she felt chills, sleepy, achy, temp of 101, dizzy, sweaty, and a little nauseous. As of 10/4/18 Patient is feeling much better.
Age: 19.0
Sex: M
Vaccine: FLU4
Symptoms: Eye irritation, Lacrimation increased, Throat irritation, Urticaria
Clinical narrative: Hives, itchy throat, watery- irritated eyes reported by patient after lunch 12:50pm.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Injection site pain, Local reaction, Mass, Swelling
Clinical narrative: More than usual pain with injection and then localized swelling, redness, "lump", and tender. This occurred within a few hours after the injection and still present 24 hours later.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Tenderness
Clinical narrative: More than usual pain with injection and then localized swelling, redness, "lump", and tender. This occurred within a few hours after the injection and still present 24 hours later.
Age: 63.0
Sex: F
Vaccine: FLUC4
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Patient is experiencing severe arm pain to the point she can't lift her arm up in the mornings.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Contusion, Induration, Skin warm
Clinical narrative: Reported to employee health on 9/24/18 with a 31/4" fading bruise with a hard bump which she stated was hot to touch on 09/21/18.
Age: 63.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Chills, Influenza like illness, Pain
Clinical narrative: Flu like symptoms chills, and achiness.
Age: 52.0
Sex: M
Vaccine: FLU4
Symptoms: Chills, Hyperhidrosis, Pain, Photosensitivity reaction, Rash
Clinical narrative: Chills, diaphoresis, rash over both arms, achy. Possibly a fever last PM. Skin was sun sensitive. This morning achy and diaphoretic.
Age: 25.0
Sex: F
Vaccine: FLU4
Symptoms: Device leakage, Underdose
Clinical narrative: I heard air when I pushed the syringe barrel. The syringe emptied, but there was clear fluid running down her arm. I repeated the dose so that she would be fully vaccinated.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Myalgia, Nausea, Tremor
Clinical narrative: Chills, shakes, nausea, muscle aches and fatigue. No treatment. Has been 16 hours since onset of symptoms. According to patient symptoms are improving. Informed to call back with worsening of symptoms or symptoms that are ongoing 2-3 days after.
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Pruritus, Skin warm
Clinical narrative: Immunization Administered 10:33am (R) Deltoid IM. Warm, Red and Itchy at 11:08am TYLENOL and BENADRYL OTC.
Age: 16.0
Sex: M
Vaccine: FLU4
Symptoms: Dizziness, Gait disturbance
Clinical narrative: Patient became dizzy. Knees buckled. Pt. sat on floor and fell back but did not hit his head.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Contusion, Hyperhidrosis, Injection site erythema, Injection site swelling
Clinical narrative: On the evening of 9/20/18 swelling noted at injection site. On 9/21/18 the area of site was red and warm to touch, 9/23/18 developed fever and chill. Monday 9/24/18 had body aches and shivering, 9/25/18 became diaphoretic. 9/26/18 arm bruised, and 10/04/18 area tender to touch.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site warmth, Pain, Pyrexia, Tenderness
Clinical narrative: On the evening of 9/20/18 swelling noted at injection site. On 9/21/18 the area of site was red and warm to touch, 9/23/18 developed fever and chill. Monday 9/24/18 had body aches and shivering, 9/25/18 became diaphoretic. 9/26/18 arm bruised, and 10/04/18 area tender to touch.
Age: 2.0
Sex: M
Vaccine: FLU4
Symptoms: Dehydration, Diarrhoea, Vomiting
Clinical narrative: Approximately 20 hours after vaccine patient presented severe vomiting followed by severe diarrhea until approximately 9:00 p.m. on 10/3/2018. Was given Gatorade and applesauce to try to curb dehydration.
Age: 11.0
Sex: M
Vaccine: FLU4, HPV9, MNQ, TDAP
Symptoms: Confusional state, Pallor, Syncope
Clinical narrative: After receiving 2 IM injections in each arm the patient became pallid and had a syncopal event. The event lasted less than one moment and was self limited -he woke without any intervention. He had a very brief period of confusion and then was back to baseline neurologically prior to discharge home.
Age: 35.0
Sex: F
Vaccine: HEPAB, MMR, VARCEL
Symptoms: Feeling hot, Injection site rash, Oropharyngeal pain, Rash
Clinical narrative: Rash at the injection site that spread to trunk. Feeling hot and a sore throat.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Computerised tomogram normal, Hemiparesis, Myalgia
Clinical narrative: Patient complained about muscle soreness and weakness on his left side. Said that he was unable to get out of bed due to the symptoms for about 6 days.
Age: 82.0
Sex: M
Vaccine: FLUX, VARZOS
Symptoms: Unevaluable event
Clinical narrative: The vaccine was not given at my clinic. Pt received the flu vaccine on right arm and SHINGRIX vaccine left arm on the same day at a pharmacy.
Age: 66.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Chills, Feeling cold, Injection site pain, Injection site reaction, Musculoskeletal stiffness
Clinical narrative: After vaccination, right arm has muscle stiffness and pain from elbow up to shoulder. Hurt to touch and to move. Fingers on right arm felt swollen. Patient felt body chills and "cold" for the next 12 hours. Stiffness is slowly fading as time goes on.
Age: 66.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Pain, Peripheral swelling
Clinical narrative: After vaccination, right arm has muscle stiffness and pain from elbow up to shoulder. Hurt to touch and to move. Fingers on right arm felt swollen. Patient felt body chills and "cold" for the next 12 hours. Stiffness is slowly fading as time goes on.
Age: 22.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Warmth, Redness and Swelling arm at the site of injection, pain 8/10.