chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.0
Sex: M
Vaccine: FLU4
Symptoms: Bowel movement irregularity, Chest X-ray abnormal, Diarrhoea, Lethargy, Pyrexia
Clinical narrative: Developed fever and diarrhea that evening. Mom not sure what actual temperature was. Gave TYLENOL and stated it did not work to reduce fever. Denies vomiting. By Sunday became lethargic. Took to ER where temp was 103. Child was admitted to the hospital. CXR taken - states they told her "something was in the lungs" but was not given any definite diagnosis with that. No cough. Had IV's for fluids and antibiotics. Did not know what antibiotics he was given. Fever broke on Monday evening. Was discharged from hospital on Tuesday late afternoon/evening. Took 1 week for his BM's to return to "normal". Feels may be due in part to the Flu vaccine and does not want to subject her child to further doses. Follow up with Pediatrician 2 days after discharge from hospital.
Age: 24.0
Sex: F
Vaccine: TYP
Symptoms: Dysphagia, Dyspnoea, Swelling face
Clinical narrative: Pt is traveling in March and wanted to get imms. Pt prescribed oral typhoid since she would be traveling overseas several times over the next few years. Pt took first dose of live virus capsule at 11 am and at 3pm her face started to swell and she had trouble breathing and swallowing. She called the pharmacy and the pharmacist told her to take BENADRYL. If it didn't resolve or got worse she was to go to the ED. It resolved but came back at 11pm. She took BENADRYL again and it resolved. Pt has had injection for previous travel out of the country without a reaction. She went to travel clinic on 1/2/2019 and received injection of typhoid and did not have a reaction.
Age: 7.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Local reaction, Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: Mother reports day after receiving injection patient complaining of pain to right arm with redness, swelling, itching, describing area as orange size affected area. Patient mother took patient to Emergency Room for evaluation and treatment. Patient was diagnosed with local reaction to immunization. Patient was prescribed Benadryl 12.5mg, ibuprofen, and antibiotic to be taken twice daily by mouth for ten days.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site reaction, Urticaria
Clinical narrative: Site was bruised where the injection was and whelps above & below injection site that felt like a bruise. It lasted 1 week & 5 days.
Age: 18.0
Sex: M
Vaccine: FLU4
Symptoms: Syncope
Clinical narrative: Vaccine screening questionnaire was given to pt which he responded "no" to all questions including the question regarding history of adverse reaction after a vaccination. Pt was administered 0.5 mL of FLULAVAL in the left deltoid at 12:34pm. Approximately 6 minutes after vaccine administration pt experienced a syncopal episode that was witnessed by his father and sister. Upon re-entering the room pt was found to be sitting on the floor. Medical provider was notified who examined the pt. No head injury or other injury noted. Pt stated "this has happened before and I pass out all the time." Pt improved quickly and was stable for discharge from the clinic.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood glucose increased, Urticaria
Clinical narrative: Hives that night on arms, back, head; sugar was high. Hives still there 1/2/19. Blood sugar improved.
Sex: M
Vaccine: VARZOS
Symptoms: Chronic obstructive pulmonary disease, Haemoptysis, Pneumonia
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. In or around 21-OCT-2015, the patient was inoculated with ZOSTAVAX, (lot# and route unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving ZOSTAVAX the patient suffered from hemoptysis, chronic obstructive pulmonary disease, and reoccurring instances of pneumonia requiring hospitalizations. As a direct and proximate result of ZOSTAVAX, the patient's symptoms have resulted in physical limitations not present prior to using ZOSTAVAX. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. As a direct and proximate consequence, the patient sustained serious personal injuries and related losses including, but not limited to, the following: The patient required and will continue to require healthcare and services; the patient incurred and will continue to incur medical and related expenses; and the patient suffered and will continue to suffer mental anguish, physical pain and suffering, diminished capacity for the enjoyment of life, a diminished quality of life, and other losses and damages. Upon internal review reoccurring instances of pneumonia was considered medically significant. Reoccurring instances of pneumonia, hemoptysis, and chronic obstructive pulmonary disease were considered medically significant events. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Blindness, Deafness
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In or around 2016, the patient was inoculated with ZOSTAVAX for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving ZOSTAVAX, the patient suffered hearing and vision loss.  As a direct and proximate result of ZOSTVAX, the patient's symptoms have resulted in physical limitations not present prior to using the product. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of the patient's condition. As a result of ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of the Company's wrongful conduct, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of ZOSTAVAX, the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events were not resolved. Causality assessment was related. Hearing and vision loss were considered disabling. Upon internal review, hearing and vision loss were considered to be medically significant. Additional information has been requested.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, DTAPIPVHIB
Symptoms: Extra dose administered
Clinical narrative: Initial information received on 19-Jul-2018 regarding an unsolicited valid non-serious case received from a Physician. This case involves a two-months old female patient who received and PENTACEL and PEDIARIX concomitantly. This was a case of actual medication error as the patient received extra dose of vaccine. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided.  No concomitant therapies were reported. On an unknown date, the patient received a dose of suspect PENTACEL Vaccine lot number, exp date not reported via unknown route in the thigh NOS and a dose of suspect PEDIARIX not produced by Sanofi Pasteur lot number, exp date not reported via unknown route in the thigh nos. Medical inquiry: Physician called to ask if any interaction is known, short term and long term effects of administering PENTACEL and PEDIARIX concomitantly. Caller stated that a 2 month old female patient received both concomitantly in her thighs. No additional details reported. It was not reported if the patient experienced any adverse event. Lab data and corrective treatment: not applicable. The patient outcome: not applicable. Documents held by sender: none.
Age: 16.0
Sex: U
Vaccine: HPVX, MNQ
Symptoms: Expired product administered
Clinical narrative: Initial information received on 14-Aug-2018 regarding an unsolicited valid non-serious case received from a Nurse. This case involves a 16 years old patient who was given expired MENACTRA. This is actual medication error case as the patient received expired vaccine. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included a dose of HPV Vaccine for Immunisation on 14-August-2018. On 14-Aug-2018, the patient received a dose of suspect 0.5 ml of Meningococcal A-C-Y-W135 (D Conj) Vaccine lot U5567CA, exp date: 28-June-2018 via intramuscular route in the right arm. It was not reported if the patient experienced any adverse event. Lab data, corrective treatment: not applicable. Outcome: not applicable. 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. Documents held by sender: none.
Age: 16.0
Sex: F
Vaccine: FLUX, MNQ
Symptoms: Exposure during pregnancy
Clinical narrative: Initial information received on 27-Dec-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 16 years old female patient who was received vaccine MENACTRA lot U6143AA via intramuscular route in the right deltoid on 10-Dec-2018, while she was pregnant. The date of last menstrual period was reported as 10-Oct-2018. The estimated due date is 17-Jul-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included INFLUENZA VACCINE (Flu shot) for Immunisation. It was case of vaccine exposure during pregnancy. The patient was pregnant (first trimester) when she received vaccine. It was unknown whether patient experienced any adverse reaction after the injection. Pregnancy outcome was unknown at the time of report. List of documents held by sender- none.
Age: 3.0
Sex: F
Vaccine: FLU4
Symptoms: Product dose omission
Clinical narrative: Initial information received on 28-Dec-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 2 years old female patient who received vaccine FLUZONE QUADRIVALENT. The patient's past medical history, medical treatment(s), vaccination(s), family history and concomitant therapy were not provided. On 11-Oct-2017 patient received 0.25 ml dose of FLUZONE QUADRIVALENT with an unknown batch number via unknown route in unknown administration site. On 01-Oct-2018, the patient received a 0.5 ml second dose of same vaccine lot number not reported via unknown route in unknown administration site. It was a case of actual medication error due to missed dose. It was unknown whether adverse event occurred. 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.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Injection site swelling, Injection site warmth, Rash erythematous
Clinical narrative: Patient experienced red rash, hot to touch, possible cellulitis, swollen, well below the injection site -close to elbow. Symptoms started 24 hours after immunization.
Age: 41.0
Sex: F
Vaccine: TDAP
Symptoms: Hypoaesthesia, Impaired work ability, Injected limb mobility decreased, Injection site pain, Loss of personal independence in daily activities
Clinical narrative: Pain in area up to 10/10 since the day vaccine was given. Patient states she is unable to comb her hair, move her arm, pain worse at night. Works as paralegal now out of work as can't type due to pain. No swelling or redness. She tried cold and hot compresses. Also describes numbness and tingling in fingertips when touched in L upper arm.
Age: 41.0
Sex: F
Vaccine: TDAP
Symptoms: Paraesthesia
Clinical narrative: Pain in area up to 10/10 since the day vaccine was given. Patient states she is unable to comb her hair, move her arm, pain worse at night. Works as paralegal now out of work as can't type due to pain. No swelling or redness. She tried cold and hot compresses. Also describes numbness and tingling in fingertips when touched in L upper arm.
Age: 28.0
Sex: M
Vaccine: YF
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: High fever over 103F, chills, and body ache: took DAYQUIL and NIGHTQUIL 4x over two days.
Age: 1.17
Sex: M
Vaccine: FLU4, HEPA, MMR
Symptoms: Autism spectrum disorder, Developmental regression, Pyrexia, Rash, Unresponsive to stimuli
Clinical narrative: After vaccination he had a fever of 103 for 4 days that resolved. After 10 more days a low grade fever and rash developed for a day. Since that time, parents noted developmental regression. Previously saying "mama and dada" and interacting with parents. He stopped responding to ques. He was referred to psychologist and dx with autism. He has a twin who is developmentally normal. Met milestones for development at well visits before vaccination.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Cyanosis, Postictal state, Pyrexia, Seizure
Clinical narrative: 5-10 minute long seizure with cyanosis and postictal phase -- seizure began 12 hours after vaccination fever at time of seizure 101. Fever noted by parents prior to seizure.
Age: 16.0
Sex: F
Vaccine: HPV9
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: Patient received 2 doses of GARDASIL vaccine spaced 2 months apart, 3 weeks following both doses developed erythematous, itchy rash over the neck. After second dose rash over the neck, face, arms, back and chest as well.
Age: 14.0
Sex: F
Vaccine: HEPA
Symptoms: Loss of consciousness, Malaise
Clinical narrative: Mother reported patient felt sick and passed out for a second after leaving vaccination area. No treatment symptoms has resolved by the time reported.
Age: 16.0
Sex: M
Vaccine: FLUC4
Symptoms: Chills, Malaise, Nausea, Syncope, Tremor
Clinical narrative: Patient felt ill as soon as standing to leave vaccination room. Syncope episode (did not completely lose consciousness), blurred vision, shaking, chills, nausea, vomiting. This lasted about 15 minutes and the patient started to feel better.
Age: 16.0
Sex: M
Vaccine: FLUC4
Symptoms: Vision blurred, Vomiting
Clinical narrative: Patient felt ill as soon as standing to leave vaccination room. Syncope episode (did not completely lose consciousness), blurred vision, shaking, chills, nausea, vomiting. This lasted about 15 minutes and the patient started to feel better.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Inflammation, Pain in extremity
Clinical narrative: Pain and inflammation in the left arm.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash erythematous, Rash pruritic, Skin lesion
Clinical narrative: 4 red bumps noted to torso 5 days prior to visit (around 7/28/2018) which was 3 days after initial vaccine administration. Bumps slightly itchy at onset but no longer. Then spread with 1-2 lesions on both arms and legs. Denied any pain or itching of rash. No new foods, medications or products reported. Given onset of rash several days after injection, reaction not presumed to definitely be from vaccine, but per request of patients acting allergist, report to be filed.
Age: 7.0
Sex: M
Vaccine: FLUX, FLU4, FLU4
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Swelling in upper thigh, itching and redness. Treatment Oral Steroids Tapering(Over 11 Days) 2 2x Day for 5 days, 1 2x Day for 3 days, then 1 Per Day for 3 days.
Age: 7.0
Sex: M
Vaccine: FLUX, FLU4, FLU4
Symptoms: Erythema, Local reaction, Pruritus, Swelling
Clinical narrative: Swelling in upper thigh, itching and redness. Treatment Oral Steroids Tapering(Over 11 Days) 2 2x Day for 5 days, 1 2x Day for 3 days, then 1 Per Day for 3 days.
Age: 7.0
Sex: M
Vaccine: FLUX, FLU4, FLU4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Swelling in upper thigh, itching and redness. Treatment Oral Steroids Tapering(Over 11 Days) 2 2x Day for 5 days, 1 2x Day for 3 days, then 1 Per Day for 3 days.
Age: 42.0
Sex: M
Vaccine: FLUA3
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: None stated.
Age: 18.0
Sex: U
Vaccine: PPV
Symptoms: Erythema, Pyrexia, Swelling
Clinical narrative: Patient had swelling and redness, but also had a fever. This could potentially be due to the Lupus, but patient was advised to be seen at urgent care.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Contusion, Pyrexia
Clinical narrative: Chills, Fever, Shivering and large area bruise.
Age: 38.0
Sex: F
Vaccine: PNC13
Symptoms: Cough, Injection site erythema, Injection site induration, Injection site mass, Injection site warmth
Clinical narrative: The patient described adverse effects beginning approximately 6 hours after administration. She described initially a tennis ball sized hard lump at the injection site that is red and warm to the touch. Shortly thereafter she began experiencing fever, severe joint swelling, cough, and malaise.
Age: 38.0
Sex: F
Vaccine: PNC13
Symptoms: Joint swelling, Malaise, Pyrexia
Clinical narrative: The patient described adverse effects beginning approximately 6 hours after administration. She described initially a tennis ball sized hard lump at the injection site that is red and warm to the touch. Shortly thereafter she began experiencing fever, severe joint swelling, cough, and malaise.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Immediate post-injection reaction, Influenza like illness, Injected limb mobility decreased, Injection site joint discomfort
Clinical narrative: Fever, chills, flu-like symptoms began about 3 hours after vaccination administration. Noticeable discomfort in shoulder joint began immediately upon administration of the vaccination (during insertion of the needle and prior injection of the vaccine) to the point where I commented about this one hurting. Note: Vaccination was given high up on the shoulder area. I did not observe the angle of the injection (upward angle, parallel to floor, or downward angle). I'm not one to complain about needles as I'm a long term blood donor and have received many needle pokes. Shoulder pain is making it difficult to raise my arm above shoulder height. Noticeable pain begins when elbow is raised to 45 degree angle and beyond or when pushing against an object with that arm. Note: this pain began at vaccination administration but has progressively gotten worse over a five hour period.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: Fever, chills, flu-like symptoms began about 3 hours after vaccination administration. Noticeable discomfort in shoulder joint began immediately upon administration of the vaccination (during insertion of the needle and prior injection of the vaccine) to the point where I commented about this one hurting. Note: Vaccination was given high up on the shoulder area. I did not observe the angle of the injection (upward angle, parallel to floor, or downward angle). I'm not one to complain about needles as I'm a long term blood donor and have received many needle pokes. Shoulder pain is making it difficult to raise my arm above shoulder height. Noticeable pain begins when elbow is raised to 45 degree angle and beyond or when pushing against an object with that arm. Note: this pain began at vaccination administration but has progressively gotten worse over a five hour period.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Feeling abnormal, Headache, Injection site pain, Injection site reaction, Musculoskeletal stiffness
Clinical narrative: Intense pain at the site of injection and stiffness in RT shoulder area. As time went on pain increased and shoulder "froze"--could not be moved without excruciating pain. Ice helped the pain somewhat. After 24 hours of continuing negative progression began taking BENADRYL and Acetaminophen 500 mg. This made me so sleepy I could not stay up so went to bed and slept. Would wake up about every 5 hrs and repeated meds. 24 hrs after injection a red rash began on the upper arm near the shoulder joint. Continued taking BENADRYL and rash began fading after 24 hrs on med. Mild headache eventually set in and nightmares while sleeping. 6 days later arm is still slightly sore when moved or try to lift something heavy. Headache is better but still feel foggy--have stopped BENADRYL but continue Acetaminophen once daily. I did call urgent care and was told this is "normal" even though the paperwork the Dr office gave me said it is not and to call my doctor if these things happened. Heat has helped relax the shoulder. General over-all achiness is slowly dissipating.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Nightmare, Pain, Pain in extremity, Periarthritis, Rash erythematous
Clinical narrative: Intense pain at the site of injection and stiffness in RT shoulder area. As time went on pain increased and shoulder "froze"--could not be moved without excruciating pain. Ice helped the pain somewhat. After 24 hours of continuing negative progression began taking BENADRYL and Acetaminophen 500 mg. This made me so sleepy I could not stay up so went to bed and slept. Would wake up about every 5 hrs and repeated meds. 24 hrs after injection a red rash began on the upper arm near the shoulder joint. Continued taking BENADRYL and rash began fading after 24 hrs on med. Mild headache eventually set in and nightmares while sleeping. 6 days later arm is still slightly sore when moved or try to lift something heavy. Headache is better but still feel foggy--have stopped BENADRYL but continue Acetaminophen once daily. I did call urgent care and was told this is "normal" even though the paperwork the Dr office gave me said it is not and to call my doctor if these things happened. Heat has helped relax the shoulder. General over-all achiness is slowly dissipating.
Age: 57.0
Sex: M
Vaccine: FLU4
Symptoms: Insomnia, Rash, Rash erythematous, Rash pruritic
Clinical narrative: Per note from ER physician: 10/20/2018. HPI: 57 y/o M c/o 2 d hx of diffuse pruritic rash without any clear exposure or trigger. No outdoor exposure, no STD exposure. No environmental/chemical exposure, no Rheum Hx. No fever, mucous membrane involvement, no arthralgia, no sore throat. No IV drug use. Pt does suffer from alcoholism. Next Day ER 10/21/2018. Note from physician: Chief Complaint: My rash is getting worse. History of Present Illness: 57 y/o male presents to ED with c/o red and itchy rash that started at the palm of both hands 3 days ago. From there the rash has spread to his torso, groin, and extremities. I haven't been able to sleep at night because of the itching. Reports recent exposure to a new detergent. He lives in the woods and gets tick bites occasionally and becomes exposed to poison oak and poison ivy as well. No recent exposure to those lately. Denies pain to this rash. Denies swelling of the lips of tongue. No difficulty breathing and no difficulty swallowing. Denies any other C/O at this time. Skin rash. Famotidine 20 mg once, Methylprednisolone 125 mg once, Diphenhydramine 25 mg once.
Age: 77.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: Per medical note: Triage: 2+ edema, area red and warm to touch. Veteran received PNEUMOVAX 23 shot Tuesday and by late evening started to become painful and red. By Wednesday patient states the pain was extreme and he couldn't move arm. Hasn't taken any pain meds, used heating pad.
Age: 77.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Mobility decreased, Musculoskeletal stiffness, Oedema, Pain, Skin warm
Clinical narrative: Per medical note: Triage: 2+ edema, area red and warm to touch. Veteran received PNEUMOVAX 23 shot Tuesday and by late evening started to become painful and red. By Wednesday patient states the pain was extreme and he couldn't move arm. Hasn't taken any pain meds, used heating pad.
Age: 92.0
Sex: M
Vaccine: VARZOS
Symptoms: Confusional state, Fall, Pyrexia, Tremor
Clinical narrative: Fall occurred on evening of SHINGRIX administration (ADR reported incr. confusion, fever, shakiness) which may have contributed to fall event. No changes needed at this time; 2nd dose of vaccine will not be ordered.
Age: 3.0
Sex: F
Vaccine: JEV1
Symptoms: Dermatitis contact, Rash
Clinical narrative: 11/23/18 AM Parents brought child into Outpatient Clinic. Child has a spotty rash on left cheek and both legs that started on 11/22/18. No fever, no respiratory Sx, no other Sx. Parents stated that last week they had soaked the child's sheets for 24 hours in OXYCLEAN and that the child does sleep on her sheets with her left cheek on the sheet. Parents think might be a contact rash? Child had received her #2 Japanese encephalitis vaccination on 11/15/18. Informed parents that a rash is not a common side effect to the Japanese encephalitis vaccination. Family is leaving for their trip on 11/26/18. Advised parents to go to a walk-in health clinic today to have child's rash evaluated by a provider. 11/23/18 PM Telephone call from FOC. Child was taken into a walk-in clinic for evaluation of the rash. Per FOC, provider did not think rash was bacterial, viral or related to the vaccination. Provider felt rash was a contact rash and advised parents to obtain some hypoallergenic detergent, and to get some CLARITIN and cortisone cream for the Sx. FOC to call clinic on 11/25/18 to inform if Sx have resolved. 11/26/18 No return call from FOC. Family left early this AM on their trip until 12/28/18. PHN to call family after they return from their trip to see if child recovered from the rash. 1/2/19 TC to FOC. FOC states cortisone cream was put on the rash for Sx relief, family switched to a hypoallergenic detergent and the rash did resolve.
Age: 22.0
Sex: F
Vaccine: MNQ
Symptoms: Urticaria
Clinical narrative: Patient received MENACTRA vaccine at Pharmacy and developed a hive like reaction shortly after receiving vaccine. Patient took BENADRYL x2.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Fatigue, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Fatigue/4 days. Dizziness. Fever/4 hrs./TYLENOL. 101 degrees. Pain/redness/swelling at site/4 days.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Fatigue/4 days. Dizziness. Fever/4 hrs./TYLENOL. 101 degrees. Pain/redness/swelling at site/4 days.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Blindness, Blood test, Computerised tomogram, Hypotension, Presyncope
Clinical narrative: Lost vision and almost fainted, "very low" blood pressure occurring off and on for a week. Emergency room said it was a migraine but it was not.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: X-ray
Clinical narrative: Lost vision and almost fainted, "very low" blood pressure occurring off and on for a week. Emergency room said it was a migraine but it was not.
Age: 54.0
Sex: M
Vaccine: FLU4
Symptoms: Arthralgia, Pain, Pain in extremity
Clinical narrative: Pain in arm radiating to elbow not alleviated upon seeing physician on 12-21-18. Pain is aggravated by lifting and movement. On NSAIDS for 2 weeks and if no improvement considering steroid injection, orthopaedic review or physical therapy.
Age: 14.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Herpes zoster, Pain, Rash, Varicella virus test positive
Clinical narrative: Shingles-pain started 12/13/18, rash 12/17/18.
Age: 67.0
Sex: M
Vaccine: FLUR4
Symptoms: Laboratory test normal, Myalgia, Pyrexia, Syncope, White blood cell count decreased
Clinical narrative: Fainting - true full syncope on day 5 after FLUBLOK. Had 3 day myalgia, fever prodrome. Low WBC in ER.
Age: 53.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Acute respiratory distress syndrome, Anaphylactic reaction
Clinical narrative: Pt went into acute respiratory distress after the ppsv 23 vaccine was given. Patient given EPIPEN x 2. BENADRYL 50 mg IM injection.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Mobility decreased, Pain in extremity, Peripheral swelling
Clinical narrative: Pt's arm swelled up to twice it's normal size. Also was very painful, so painful the pt could not move it.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Mobility decreased, Pain in extremity, Peripheral swelling
Clinical narrative: Pt's arm swelled up to twice it's normal size. Also was very painful, so painful the pt could not move it.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling, Rash generalised
Clinical narrative: Arm swelling hours after administration generalized rash developed days after.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Injection site swelling, Product administered at inappropriate site
Clinical narrative: Patient experienced swelling and pain at injection site. Vaccine was given high in the shoulder on 12/30/18. Patient has been taking over the counter pain medicine to alleviate pain.
Sex: U
Vaccine: VARCEL
Symptoms: Accidental exposure to product, Circumstance or information capable of leading to medication error, Exposure via eye contact, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to another medical assistant, a patient of unknown age and gender. There was no information reported regarding the patient's medical history, concurrent conditions or concomitant medications. On 05-DEC-2018, an unspecified amount of VARIVAX (lot # R017637, expiration date 20-JUN-2010) and sterile diluent  (lot # and expiration date unknown by the reporter) "squirted" into the patient's eye while she was administering a dose of the vaccine to an unspecified child who "moved during administration" (Occupational exposure to product). No adverse effects reported, and no additional information was provided. This is one of 2 reports from the same reporter (information captured in MARRS case # 1901USA000226); Sender's Comments: US-009507513-1901USA000226.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Injection site rash
Clinical narrative: This spontaneous report was received from a nurse refers to a 65 year old male patient. The  patient medical history, drug reactions and allergies were not reported. The patient's current condition included diabetes mellitus, hypertension, arthritis and gastrooesophageal reflux disease. Concomitant therapies included NORVASC, aspirin, benazepril hydrochloride, CELEXA, diclofenac, LANTUS, metformin, omeprazole and simvastatin. On 17-DEC-2018 the patient was vaccinated with PNEUMOVAX 23, (dose, units, frequency, lot# and expiration date unknown) intramuscularly to prevent pneumococcal disease. On 19-DEC-2018, the patient developed a rash at the site of PNEUMOVAX 23. On an unknown date after this, the patient was started on ZANTAC, BENADRYL, and triamcinolone cream (manufacturers unknown) for the rash. The patient has not recovered. Causality of the event was not reported.
Sex: F
Vaccine: PPV, PPV
Symptoms: Dyskinesia, Feeling abnormal, Injection site pain, Injection site swelling, Insomnia
Clinical narrative: This spontaneous report was received from a 77-year-old consumer reporting on herself. The patient's medical history was not reported. The patient's drug reactions/allergies included "carbamazepine which affects her stomach because of acid reflux (drug hypersensitivity)". Concomitant therapies included cyanocobalamin (vitamin B12)) and an acid reflux pill. On 01-DEC-2018, the patient was vaccinated with PNEUMOVAX 23 (strength, lot # and expiry date not reported) dose 1 in the left arm for prophylaxis. On 01-DEC-2018 (reported as within an hour of injection), the patient experienced swelling and soreness at the injection site (vaccination site swelling and injection site pain), and "nerve jerking" in several places in that arm (myoclonus). The patient reported that both day and night her arm felt like "somebody is doing a nerve conduction test" on her and keeps her up at night (feeling abnormal). The patient used salves and creams as a treatment to alleviate the pain, but it was for short time and the pain returned. On an unknown date in 2018, the patient sought medical attention from an orthopedic physician. Outcome of vaccination site swelling, feeling abnormal, myoclonus and injection site pain was reported as not recovered. Causality assessment was not reported.
Sex: F
Vaccine: PPV, PPV
Symptoms: Myoclonus
Clinical narrative: This spontaneous report was received from a 77-year-old consumer reporting on herself. The patient's medical history was not reported. The patient's drug reactions/allergies included "carbamazepine which affects her stomach because of acid reflux (drug hypersensitivity)". Concomitant therapies included cyanocobalamin (vitamin B12)) and an acid reflux pill. On 01-DEC-2018, the patient was vaccinated with PNEUMOVAX 23 (strength, lot # and expiry date not reported) dose 1 in the left arm for prophylaxis. On 01-DEC-2018 (reported as within an hour of injection), the patient experienced swelling and soreness at the injection site (vaccination site swelling and injection site pain), and "nerve jerking" in several places in that arm (myoclonus). The patient reported that both day and night her arm felt like "somebody is doing a nerve conduction test" on her and keeps her up at night (feeling abnormal). The patient used salves and creams as a treatment to alleviate the pain, but it was for short time and the pain returned. On an unknown date in 2018, the patient sought medical attention from an orthopedic physician. Outcome of vaccination site swelling, feeling abnormal, myoclonus and injection site pain was reported as not recovered. Causality assessment was not reported.
Sex: F
Vaccine: PPV, PPV
Symptoms: Dyskinesia, Insomnia, Mobility decreased, Pain, Peripheral swelling
Clinical narrative: This spontaneous report was received from a 77-year-old consumer reporting on herself. The patient's medical history was not reported. The patient's drug reactions/allergies included "carbamazepine which affects her stomach because of acid reflux (drug hypersensitivity)". Concomitant therapies included cyanocobalamin (vitamin B12)) and an acid reflux pill. On 01-DEC-2018, the patient was vaccinated with PNEUMOVAX 23 (strength, lot # and expiry date not reported) dose 1 in the left arm for prophylaxis. On 01-DEC-2018 (reported as within an hour of injection), the patient experienced swelling and soreness at the injection site (vaccination site swelling and injection site pain), and "nerve jerking" in several places in that arm (myoclonus). The patient reported that both day and night her arm felt like "somebody is doing a nerve conduction test" on her and keeps her up at night (feeling abnormal). The patient used salves and creams as a treatment to alleviate the pain, but it was for short time and the pain returned. On an unknown date in 2018, the patient sought medical attention from an orthopedic physician. Outcome of vaccination site swelling, feeling abnormal, myoclonus and injection site pain was reported as not recovered. Causality assessment was not reported.
Age: 77.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Dyskinesia, Feeling abnormal, Injection site pain, Injection site swelling, Insomnia
Clinical narrative: I had a pneumonia shot (PNEUMOVAX 23) on Dec. 1, 2018. The left arm became swollen. I could hardly move it. The shot was given by the pharmacist at pharmacy. The nerves in the left arm began jerking non-stop and have continued to date. I have been unable to sleep due to the throbbing pain.
Age: 77.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Myoclonus
Clinical narrative: I had a pneumonia shot (PNEUMOVAX 23) on Dec. 1, 2018. The left arm became swollen. I could hardly move it. The shot was given by the pharmacist at pharmacy. The nerves in the left arm began jerking non-stop and have continued to date. I have been unable to sleep due to the throbbing pain.
Age: 77.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Dyskinesia, Insomnia, Mobility decreased, Pain, Peripheral swelling
Clinical narrative: I had a pneumonia shot (PNEUMOVAX 23) on Dec. 1, 2018. The left arm became swollen. I could hardly move it. The shot was given by the pharmacist at pharmacy. The nerves in the left arm began jerking non-stop and have continued to date. I have been unable to sleep due to the throbbing pain.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 21-DEC-2018, the patient was vaccinated with a dose of improperly stored PROQUAD (exact dose, route and site of administration were not reported; lot number R020816, expiration date 16-JAN-2020) for prophylaxis. The administered dose was received as part of a late shipment. It was not possible to determine either the time frame or the temperature of the vaccine storage. No information regarding any previous temperature excursions was provided. Digital Data Logger was not used. No adverse effects were reported. The outcome of product distribution issue was unknown. The causality between the event and suspect vaccine was not reported.
Age: 1.75
Sex: M
Vaccine: DTAP, HIBV, IPV, MMR, PNC, VARCEL
Symptoms: Cerebellar ataxia, Crying, Pyrexia, Sinusitis, Vomiting
Clinical narrative: Information has been downloaded from regulatory authority (HQ5628306SEP2001). This spontaneous report was received from a health professional and refers to a 21 month old male patient. The patient's concurrent conditions and concomitant therapies were not reported. The patient's medical history included unspecified ear infection. On 23-APR-2001, the patient was vaccinated with the first dose of VARIVAX, 1 dosage form, subcutaneously, lot # 636578/1471K, expiration date 28-SEP-2002 for immunization, the first dose of M-M-R II 1 dosage form, subcutaneously, lot # reported as 1274K (expiration date was not reported) for immunization, the first dose of PREVNAR 1 dosage form, intramuscularly, batch/lot number 475-382 (expiration date was not reported) for immunization, the first dose of poliovirus vaccine inactivated (unspecified) 1 dosage form (route of administration, lot # and expiration date were not reported) for immunization, the first dose of hib conj vaccine (unspecified carrier) injection, 1 dosage form once daily (qd), intramuscularly, batch/lot number 474-714 (expiration date was not reported) for immunization, and the first dose of INFANRIX 1 dosage form qd, intramuscularly, batch/lot number 970A2 (expiration date was not reported) for immunization. On 28-JUN-2001, the patient experienced acute cerebellar ataxia, crying, vomiting, fever and sinus infection. The outcome of all events was unknown. The relatedness between the events and suspect therapies was not reported. The reporter considered all events to be medically significant. Lot number # 1274K is an invalid lot number for measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live.
Sex: M
Vaccine: VARZOS
Symptoms: Sudden hearing loss
Clinical narrative: Information has been received on 31-DEC-2018 regarding a case in litigation from a lawyer concerning a male patient of unknown age. There was no information provided regarding the patient's concurrent conditions, medical history or concomitant medications. In or around December 2012, the patient was inoculated with the ZOSTAVAX (lot number, expiration, dose and route unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster.) Shortly after receiving the ZOSTAVAX, the patient suffered sudden hearing loss in his right ear. As a direct and proximate result of ZOSTAVAX the patient's symptoms have resulted in physical limitations not present prior to using ZOSTAVAX. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of the patient's condition. As a result of ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of ZOSTAVAX, the patient suffered serious, progressive, permanent and incurable injuries, as well as conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The patient has suffered and incurred damages, including medical expenses, loss of accumulations and other economic and non-economic damages. The patient has paid and has become liable to pay for medical aid, treatment, monitoring, medications and other expenditures and will necessarily incur further expenses of a similar nature in the future as a proximate result of ZOSTAVAX. The outcome of the events is not recovered. The causality of the events is related. Sudden hearing loss in his right ear was considered to be disabling. Upon internal review, sudden hearing loss in his right ear was considered to be medically significant. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia
Clinical narrative: Information has been received regarding a case in litigation from a lawyer, a female patient of unknown age, and his spouse. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In or around March 2013, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving the ZOSTAVAX, the patient suffered a shingles and post herpetic neuralgia. The patient also experienced mental and emotional distress due to resulting physical limitations and the seriousness of the patient's condition. As a result of the ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event was considered to be not recovered. Shingles and post herpetic neuralgia were considered disabling. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Cerebral infarction
Clinical narrative: Information has been received regarding a case in litigation from a lawyer, spouse and a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In or around October 2012, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date [reported as "shortly after" receiving the ZOSTAVAX], the patient suffered a subacute infarct along the right occipital lobe. As a direct and proximate result of the ZOSTAVAX vaccine, the patient's symptoms have resulted in physical limitations not present prior to using ZOSTAVAX. The patient also experienced mental and emotional distress due to resulting physical limitations and the seriousness of the patient's condition. As a result of the ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event was considered to be  not recovered. Upon internal review, subacute infarct along the right occipital lobe was determined to be medically significant. Subacute infarct along the right occipital lobe was considered to be disabling. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Optic nerve injury
Clinical narrative: Information has been received on 31-DEC-2018 regarding a case in litigation from a lawyer concerning a female patient of unknown age. There was no information provided regarding the patient's concurrent conditions, medical history or concomitant medications. In or around January 2015, the patient was inoculated with the ZOSTAVAX (lot number, expiration, dose and route unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster.) Shortly after receiving the ZOSTAVAX, the patient suffered optic nerve damage. As a direct and proximate result of ZOSTAVAX the patient's symptoms have resulted in physical limitations not present prior to using ZOSTAVAX. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of the patient's condition. As a result of ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of ZOSTAVAX, the patient suffered serious, progressive, permanent and incurable injuries, as well as conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The patient has suffered and incurred damages, including medical expenses, loss of accumulations and other economic and non-economic damages. The patient has paid and has become liable to pay for medical aid, treatment, monitoring, medications and other expenditures and will necessarily incur further expenses of a similar nature in the future as a proximate result of ZOSTAVAX. The outcome of the event is not recovered. The causality of the event is related. Optic nerve damage was considered to be disabling. Upon internal review, optic nerve damage was considered to be medically significant. Additional information has been requested.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: This spontaneous non-valid report was received from a registered nurse and refers to a patient of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications and drug reactions or allergies was provided. On an unknown date, the patient was vaccinated with VARIVAX and M-M-R II intramuscularly for prophylaxis (dose, lot# and expiration date were not reported). No adverse symptoms were reported.