chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 21.0
Sex: F
Vaccine: MEN
Symptoms: Injection site pain, Injection site swelling, Muscle spasms, Muscular weakness, Nausea
Clinical narrative: Severe pain, swelling, lump, redness at the injection site, weakness in left arm. joint pain, arthritis, muscle spasms, headaches, fatigue, nausea, vomiting, loss of appetite, dizziness, difficulty breathing, wheezing, anxiety.
Age: 21.0
Sex: F
Vaccine: MEN
Symptoms: Vomiting, Wheezing
Clinical narrative: Severe pain, swelling, lump, redness at the injection site, weakness in left arm. joint pain, arthritis, muscle spasms, headaches, fatigue, nausea, vomiting, loss of appetite, dizziness, difficulty breathing, wheezing, anxiety.
Age: 43.0
Sex: F
Vaccine: DTAP
Symptoms: Drug administered to patient of inappropriate age, No adverse event, Wrong drug administered
Clinical narrative: NO adverse effects. Patient received DTAP instead of receiving TDAP.
Age: 26.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema
Clinical narrative: 5 X 5 CM area of erythema at injection site.
Sex: F
Vaccine: VARZOS
Symptoms: Expired product administered, Herpes zoster, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report was received from a consumer referring to an 85 year old female patient (reporter's mother). The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date in approximately June 2016 (reported as 2 or 3 weeks ago), the patient was vaccinated with an expired dose of ZOSTAVAX, subcutaneously, 1 shot (dose, lot# and expiry date not reported) for prevention of shingles. Subsequently, after 4 or 5 days approximately in June 2016 (also reported as 2 or 3 weeks ago), the patient started to develop symptoms which was very swollen and felt warm at the injection site. The patient sought medical attention- physician office visit, who did not provide any treatment. No lab test was performed. At the time of this report, the patient was slowly recovering as the injection site reaction was beginning to dissipate. No further information provided. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On 11-JUL-2016, the patient was vaccinated with a dose of improperly stored VARIVAX lot/batch # L035124, expiry date 14-SEP-2017 (dose, strength, vaccination site, route unspecified). No adverse effects were reported. Product quality complaint (PQC) was not involved. No additional information was provided. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: (R) thigh swelling to knee, mild redness, N/V intact, resolving after 3 days.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Feeling hot, Swelling
Clinical narrative: Swollen, redness and warmth, 1-3 days after injection. BENADRYL. TYLENOL.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Blood glucose normal, Presyncope
Clinical narrative: Patient had near syncope episode approximately 45 seconds after last immunization started, at 5:40pm. VS taken BP - 90/58, pulse ox 99%, 66 BPM. Ice pack applied to chest, neck, and head. Pt could state name and talk. Gave juice and snacks. At 5:50 BP 98/58, pulse 78, and pulse ox 99%.
Age: 18.0
Sex: M
Vaccine: HEPA, HPV9, MNQ
Symptoms: Asthenia, Headache, Insomnia, Lethargy, Musculoskeletal stiffness
Clinical narrative: Insomnia; Weakness and lethargy - very marked; Fever - 102; Headache; Neck stiffness.
Age: 18.0
Sex: M
Vaccine: HEPA, HPV9, MNQ
Symptoms: Pyrexia
Clinical narrative: Insomnia; Weakness and lethargy - very marked; Fever - 102; Headache; Neck stiffness.
Age: 58.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Body aches, fever, chills 101 degrees F.
Age: 15.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Erythema, Pruritus, Skin warm, Swelling
Clinical narrative: Pt. noticed no swelling and itching in back of left arm at location of varicella inject. Symptoms first noted morning after inject - red, puffy, warm, itchy, size of palm of her hand. Advised BENADRYL topical anti-itch lotion or hydrocortisone.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Headache, Injection site erythema, Injection site induration, Injection site reaction, Injection site vesicles
Clinical narrative: Had MMR #2 8/2/16. Developed welt of site with redness, induration peeling 8/2/16. Today 8/4/16 had headache, photophobia, increased redness and blisters at site and pain and swelling of L knee and ankle, improving with ibuprofen, TYLENOL. Much improved.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Joint swelling, Photophobia, Skin exfoliation, Urticaria
Clinical narrative: Had MMR #2 8/2/16. Developed welt of site with redness, induration peeling 8/2/16. Today 8/4/16 had headache, photophobia, increased redness and blisters at site and pain and swelling of L knee and ankle, improving with ibuprofen, TYLENOL. Much improved.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: PNEUMOVAX administered 8/2/16 to right deltoid. Presented to office 8/4/16. Injection site erythema, edema and warmth noted.
Age: 1.02
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Injection site cellulitis, Pyrexia
Clinical narrative: Developed fever and cellulitis left thigh beginning 8-9 days after vaccine. Began treatment with cephalexin.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Hypersensitivity, Pruritus, Rash, Viral infection
Clinical narrative: Vaccine administered on 7/21, pt began to itch and have rash on stomach, groin and lower legs on 7/26. Visited MD on 7/28 received prednisone shot and was taking BENADRYL. On 8/2 - went back to MD - received pred pack and cream (topical) - per pt spouse MD thought allergic rxn then a viral rxn at 2nd visit.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site nodule, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient received PCV13 on 7/28/16 - Next day noted pain, redness and swelling of injection site >1cm knot noted at site. Redness spread to cover an area approx. 10cm x 6cm of upper arm. Area slightly warm to touch.
Age: 45.0
Sex: F
Vaccine: TDAP
Symptoms: Pruritus, Rash
Clinical narrative: Vaccine given at 10:00 a, at 10.05 oz pt. c/o itchiness upper back area. Right arm with rashes, no SOB, not in pain, stable 11.27 am. Talked to pt on phone- feels better sometimes, took BENADRYL OTC.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a state government immunization official referring to multiple unknown patients of unspecified age and gender. On unknown dates the patients were vaccinated with improperly stored VARIVAX (lot # L029472, exp 06-AUG-2017). No adverse effects reported. The excursive temperature and time frame was 14.8 Fahrenheit degree for 1 hour and 44 minutes. The call was because of a data logger. There was no previous temperature excursion. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates in 2016 (reported as between "18-JUL-2016 and 04-AUG-2016"), the patients were vaccinated with improperly stored doses of VARIVAX lot # M000756 with expiration date: 06-JAN-2018 and lot # M006731 with expiration date: 09-FEB-2018 (dose and route of administration were not reported). Administered doses of vaccines experienced the temperature excursion of - 10.8 degrees Celsius for 35 minutes. Data logger was involved. There were no previous excursions reported. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates in 2016 (reported as "between 18-JUL-2016 and 04-AUG-2016"), the patients were vaccinated with improperly stored doses of PROQUAD lot # M004894 with expiration date: 27-JUL-2017 and lot # L007228 with expiration date: 03-SEP-2016 (dose, therapy type and route of administration were not reported). Administered doses of vaccines experienced the temperature excursion of -10.8 degrees Celsius for 35 minutes. Data logger was involved. There were no previous excursions reported. This is one of two reports received from the same reporter. Additional information has been requested.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Biopsy, Skin fissures, Tinea pedis
Clinical narrative: Initial unsolicited report received from a consumer on 11 November 2015. This case involves a 43-year-old female patient who was vaccinated with a first dose of FLUZONE (batch number: UH910AA, expiration date: 30 June 2014, dose was not reported) intramuscularly in left arm on 14 February 2014. The patient's medical history and concomitant medication were not reported. On an unspecified day in March 2014, two-three weeks following the vaccination, the patient experienced athlete foot type proplem and fissures developed in both feet. The patient felt that athlete foot type proplem was caused by her laundry detergent. Patient was evaluated and treated symptomaticly by her physician and dermatologist. The patient required ER or doctor visit. Laboratory investigation includes, patch testing positive for acrolates, methyl 2 hydroxyacrylate and stated negative or positive for thimerosal. On an unspecified date, the patient received OTC preparations, symptomatic treatment and UV light treatments and steroids as a corrective treatment. As of August 2014, the patient was not recovered from events as the symptoms remained and the patient had to stop working. List of documents held by sender: none.
Age: 68.0
Sex: F
Vaccine: FLU4
Symptoms: Bronchitis, Cough, Fatigue, Pain in extremity, Pyrexia
Clinical narrative: Initial unsolicited report received from a consumer (patient's husband) on 11 November 2015. This case involves a female patient (age was not reported) who was vaccinated with a dose of Fluzone QIV (batch number, dose, dose in series, route and site of administration was not reported) 12 October 2015. Illness at time of vaccination was not reported. The patient had allergy to gelatin. Concomitant medications were not reported. On 13 October 2015, next day following the vaccination, the patient experienced pain in arm, tiredness, fever. Then next week, on unspecified date, patient developed bronchitis. Patient did see a health care provider at an urgent care facility and was put on antibiotic. Did not improve so returned to own primary care physician for evaluation and treatment. placed on another antibiotic. Symptoms cleared up for short time but thencough and wheezing returned. Returned to own primary care physician and given steroids. Continues to have cough and slight wheezing to 11 November 2015. The patient required emergency room and physician visit. Lab data was not reported. The patient received corrective treatments with antibiotic and steroids. On unspecified date, four days after onset the patient was recovered from pain in am, tiredness, fever. Patient was not recovered from bronchitis, cough and wheezing. List of documents held by sender: none.
Age: 68.0
Sex: F
Vaccine: FLU4
Symptoms: Wheezing
Clinical narrative: Initial unsolicited report received from a consumer (patient's husband) on 11 November 2015. This case involves a female patient (age was not reported) who was vaccinated with a dose of Fluzone QIV (batch number, dose, dose in series, route and site of administration was not reported) 12 October 2015. Illness at time of vaccination was not reported. The patient had allergy to gelatin. Concomitant medications were not reported. On 13 October 2015, next day following the vaccination, the patient experienced pain in arm, tiredness, fever. Then next week, on unspecified date, patient developed bronchitis. Patient did see a health care provider at an urgent care facility and was put on antibiotic. Did not improve so returned to own primary care physician for evaluation and treatment. placed on another antibiotic. Symptoms cleared up for short time but thencough and wheezing returned. Returned to own primary care physician and given steroids. Continues to have cough and slight wheezing to 11 November 2015. The patient required emergency room and physician visit. Lab data was not reported. The patient received corrective treatments with antibiotic and steroids. On unspecified date, four days after onset the patient was recovered from pain in am, tiredness, fever. Patient was not recovered from bronchitis, cough and wheezing. List of documents held by sender: none.
Sex: F
Vaccine: FLU4
Symptoms: Paraesthesia, Rash
Clinical narrative: Initial unsolicited report received from a Nurse on 11 November 2015. This case involves an adult female patient (age was not reported) who was vaccinated with a dose of FLUZONE QIV (Dose, route and site of administration, dose in series, batch number were not reported) on 4 November 2015. The patient's Pre-existing physician diagnosed allergies, birth defects, medical conditions and Illness at time of vaccination were not reported. The patient's Concomitant medications were not reported. On 4 November 2015, same day after vaccination, the patient developed a rash on chest, neck and on 9 November 2015, 5 days after vaccination patient experienced bilateral tingling in feet. The patient required ER/doctor visit. The patient's laboratory data was not reported. The patient's corrective treatment includes Medrol dose pack and Claritin. The outcome of the events was reported as not recovered. List of documents held by sender: none.
Age: 86.0
Sex: F
Vaccine: FLU3
Symptoms: Discomfort, Injection site erythema, Injection site warmth, Swelling
Clinical narrative: Initial unsolicited report received from a nurse via other company (Novartis) on 16 November 2015. Manufacturing control number: PUS2015US130007 This case involves an 86-year-old female patient who was vaccinated with FLUZONE HD (batch number, expiration date, dose, dose number, route and site of administration were not reported) on an unspecified date. The patient's medical history and concomitant medication were not reported. On an unspecified date following the vaccination, the patient developed a reaction about one inch away from the injection site that was eight inches in length and six inches in diameter. The reaction at the injection site was hot and red to the tough. On an unspecified date, the patient complained of discomfort and swelling. Laboratory investigation and corrective treatment were not reported. The outcome of the events was not reported. Documents held by sender: none. Follow-up information received from a nurse via other company (Novartis) on 19 January 2016. No new information was provided.
Age: 19.0
Sex: F
Vaccine: HPVX, MNQ
Symptoms: Chills, Ear pain, Headache, Myalgia, Nausea
Clinical narrative: Muscle soreness, fever, chills, headache, nausea - all supportive treatment. Neck pain, ear ache.
Age: 19.0
Sex: F
Vaccine: HPVX, MNQ
Symptoms: Neck pain, Pyrexia
Clinical narrative: Muscle soreness, fever, chills, headache, nausea - all supportive treatment. Neck pain, ear ache.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a patient of an unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored PROQUAD (dose, lot #, expiration date and route of administration were not reported). There were no adverse symptoms reported. Product quality complaint (PQC) was not involved. Additional information is not expected as there was no consent for further contact.
Age: 67.0
Sex: M
Vaccine: PNC13
Symptoms: Induration, Swelling
Clinical narrative: Pt reported reaction to immunization on 4/18/2016, after immunization was given 12/8/2015. Reaction was observed by pt's wife, who is an RN. Hardness and swelling.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: Patient has a red rash at the injection site and she is reporting that it itches. Dr. was notified.
Age: 5.0
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Erythema, Injection site cellulitis, Local reaction, Peripheral swelling, Skin warm
Clinical narrative: ARM RED, HOT AND SWOLLEN.
Age: 4.0
Sex: M
Vaccine: HEP, MMRV
Symptoms: Abdominal pain upper, Arthralgia, Autoimmune disorder, Blood test abnormal, Blood urine present
Clinical narrative: Legs very itchy. Stomach aches, nausea. Joint pain in knees. Severe, stippled bruising on legs. No treatment. Joint aches and bruising have not subsided. Blood detected in urine with diagnosis of HSP by administering physician on 7/15/2016.
Age: 4.0
Sex: M
Vaccine: HEP, MMRV
Symptoms: Contusion, Henoch-Schonlein purpura, Nausea, Pruritus
Clinical narrative: Legs very itchy. Stomach aches, nausea. Joint pain in knees. Severe, stippled bruising on legs. No treatment. Joint aches and bruising have not subsided. Blood detected in urine with diagnosis of HSP by administering physician on 7/15/2016.
Age: 8.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Unevaluable event
Clinical narrative: No adverse event happened.
Age: 0.35
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Injection site erythema, Injection site reaction, Rash papular
Clinical narrative: Large red papular rash over anterior thigh where injection was given.
Sex: M
Vaccine: FLU3
Symptoms: Guillain-Barre syndrome
Clinical narrative: Initial unsolicited report received from a non-healthcare professional on 23 November 2015. This case is linked with 2015SA194971 (same reporter). This case involves a male patient who was vaccinated with a dose of FLUZONE HD (batch number, expiration date, dose, dose number, were not reported) on an unspecified date. The patient's medical history and concomitant medication were not reported. On an unspecified date, following the vaccination, the patient had Guillain barre. Laboratory investigations and corrective treatments were not reported. The outcome of the event was not reported. Upon internal review, the case was considered to be serious due to important medical event: Guillain Barre Follow-up information received from a consumer on 11 January 2016. It was reported that in October 2015 (unspecified date) patient was vaccinated with a dose of FLUZONE HD. Pre-existing physician-diagnosed allergies, birth defect, medical conditions were reported none. Patient had not taken any vaccination within four-weeks prior to administration of FLUZONE HD. Patient was hospitalized on an unspecified date which resulted in prolongation of hospital. List of documents held by sender: none. Required emergency room/ doctor visit. It was reported that the patient was not recovered and stated that pateint was permanently disabled. Sender's Comments: Follow-up received on 11-Jan-2016, does not change the medical assessment of the case. Guillain Barre Syndrome is listed with INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. This case lacks information about time to onset from vaccination, hence temporal association cannot be established. Also, investigation results (electromyogram, CSF cell counts and units for protein levels, tendon reflex examination) and etiological investigation results in particular infectious work-up are not provided. Based on the limited available information, case cannot be assessed for now.
Age: 84.0
Sex: F
Vaccine: FLUX, PNC13
Symptoms: Arthralgia, Musculoskeletal pain, Myalgia
Clinical narrative: Initial unsolicited report received from a consumer via other pharmaceutical company (Pfizer) on 25 November 2015. This case involves 84-years-old female patient who was vaccinated with an injection of Flu vaccine; with an injection of dose of PREVNAR 13 (batch number, expiry date, manufacturer: other, dose, dose in series, route of administration were not reported) both via left arm on 05 October 2015 in doctor's office. The patient had a medical history of breast cancer which diagnosed in 1992 and 1996, she hasn't had cancer again for over 15 years. Diabetes (controlled by exercise and a small dose diabetes pill and diet), lymph edema in right arm began in late 1990's. Concomitant medications were not reported. On 08 October 2015, three days following the vaccination, the patient had developed muscle pain and joint pain. It was reported that, the pain was in her shoulder muscle like when moving her arm. Laboratory data and corrective treatment were not reported. The patient had not recovered from the events. List of documents held by sender: none. Follow-up received from consumer via other pharmaceutical company (Pfizer) on 14-Dec-2015. No additional information was received.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site bruising, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: 8/4-Client in a.m. red swollen and warm to touch, 2 inches below original injection. Feels better today client states. There is only a bruise at deltoid muscle-never has been redden or swollen at injection area.
Age: 13.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Asthenia, Fatigue, Headache, Immune thrombocytopenic purpura, Laboratory test abnormal
Clinical narrative: C/O headache increased fatigue, weakness. Developed Idiopathic thrombocytopenic purpura (ITP).
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Seizure like phenomena
Clinical narrative: After receiving Tdap, MCV, HPV pt had seizure like activity. It is unclear if this was psychogenic event triggered by stress/fear of vac vs. syncopal episode w/tonic clonic movements.
Age: 60.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Dyspnoea, Heart rate increased, Injected limb mobility decreased, Nausea
Clinical narrative: Received Tdap on 7-12-2016. On 7-18 patient walked into clinic c/o adverse reaction of hives, dizziness, nausea, swelling in throat, rapid HR, (SOB). Today only (R) arm pain and problem lifting (R) arm. Hives are improved.
Age: 60.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in extremity, Pharyngeal oedema, Urticaria
Clinical narrative: Received Tdap on 7-12-2016. On 7-18 patient walked into clinic c/o adverse reaction of hives, dizziness, nausea, swelling in throat, rapid HR, (SOB). Today only (R) arm pain and problem lifting (R) arm. Hives are improved.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Dysgeusia, Dyspnoea, Swollen tongue
Clinical narrative: Metallic taste in mouth, swollen tongue, felt like she could not breathe, resolved with intervention after approx. 40 minutes.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Dizziness, Headache, Vomiting
Clinical narrative: Vomiting, headache, dizziness resolved in 24 hours without intervention.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: Sore arm, tingling on both legs, tingling resolved within 24 hours-MOTRIN for pain.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Erythema, Fatigue, Pain, Pain in extremity, Peripheral swelling
Clinical narrative: ARM red, swollen, painful to touch and with movement, red streaking to arm pit, very tender, achy and tired, swelling lasted 3 days, still tender as of 8/5.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Tenderness
Clinical narrative: ARM red, swollen, painful to touch and with movement, red streaking to arm pit, very tender, achy and tired, swelling lasted 3 days, still tender as of 8/5.
Age: 57.0
Sex: F
Vaccine: MMR
Symptoms: Muscle spasms
Clinical narrative: Describes cramping of arms and legs. Told to call occupational medicine for follow up. Cramping occurred 3 days after vaccination.
Age: 0.34
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Diarrhoea, Enema administration, Faeces discoloured, Haematochezia, Vomiting
Clinical narrative: Vomiting and dark green loose stools w/blood at 2:00 am one week following vaccination. Admitted to hospital. Treatment was two air enemas. Discharged 8/5/16.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Back pain, Chills, Hypersensitivity, Influenza like illness, Injection site erythema
Clinical narrative: 66-year-old male presents to urgent care complaining of acute onset pain in the right deltoid muscle at the site of the intramuscular injection of the PNEUMOVAX 2 days ago. He noticed the pain yesterday gradually and getting worse throughout the day. He describes deep soreness aching, pain radiating down the arm, unable to sleep, chills last night. He had mild flulike symptoms yesterday now resolved. No known fever. No facial swelling, generalized rash, shortness of breath, choking. No upper extremity swelling. Right arm pain subsided today compared to yesterday. He has chronic low back pain and takes gabapentin and NORCO as needed. He has been prescribed NAPROSYN in the past but has not taken this medication for the right arm pain. Assessment and plan. Allergic reaction to PNEUMOVAX localize pain at the injection site and erythema. Symptoms subsiding. May take NAPROSYN 500 mg 1 tablet twice a day for the next few days. May take BENADRYL 50 mg 1 tablet 3 times a day for the next few days as needed. Discussed potential adverse drug reactions. May try ice first or heating pad as needed. Symptoms: and pain, erythema. Treatment: Naproxen 500 mg BID, diphenhydramine 50 mg TID.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain, Sleep disorder
Clinical narrative: 66-year-old male presents to urgent care complaining of acute onset pain in the right deltoid muscle at the site of the intramuscular injection of the PNEUMOVAX 2 days ago. He noticed the pain yesterday gradually and getting worse throughout the day. He describes deep soreness aching, pain radiating down the arm, unable to sleep, chills last night. He had mild flulike symptoms yesterday now resolved. No known fever. No facial swelling, generalized rash, shortness of breath, choking. No upper extremity swelling. Right arm pain subsided today compared to yesterday. He has chronic low back pain and takes gabapentin and NORCO as needed. He has been prescribed NAPROSYN in the past but has not taken this medication for the right arm pain. Assessment and plan. Allergic reaction to PNEUMOVAX localize pain at the injection site and erythema. Symptoms subsiding. May take NAPROSYN 500 mg 1 tablet twice a day for the next few days. May take BENADRYL 50 mg 1 tablet 3 times a day for the next few days as needed. Discussed potential adverse drug reactions. May try ice first or heating pad as needed. Symptoms: and pain, erythema. Treatment: Naproxen 500 mg BID, diphenhydramine 50 mg TID.
Sex: F
Vaccine: HEPA, HPV9
Symptoms: Multiple sclerosis
Clinical narrative: This spontaneous report as received from a consumer (also receptionist at the physician's office) via company representative refers to her/her daughter unknown age. Patient's pertinent medical history, concurrent condition and concomitant medication were not reported. Previous drug reactions/ allergies were not reported. On an unknown date, the patient was vaccinated with third dose of GARDASIL 9 intramuscularly (strength, dosing details, anatomical location, lot# and expiration date were unknown). Other suspect therapy included vaccination with hepatitis A vaccine (manufacturer unknown) (strength, dosing details, anatomical location, lot# and expiration date were unknown). On an unknown date, the patient was diagnosed with multiple sclerosis. The outcome of the event was unknown. Causality assessment was not provided. No product quality complaint was involved. Upon internal review, multiple sclerosis was considered to be medically significant. Additional information has been requested.
Age: 1.11
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site warmth, Pyrexia
Clinical narrative: Warm to the touch, hard, red lump at injection sight. Low fever.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema
Clinical narrative: Redness at injection site.
Age: 35.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Cellulitis, Erythema, Pain, Peripheral swelling
Clinical narrative: Red, sore, swelling arm on friday 7/29. Patient slept all day friday. Treated at urgent care for cellulitis on saturday.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Feeling hot, Head injury, Pallor, Paraesthesia, Syncope
Clinical narrative: Child was in long line in crowded gym after receiving vaccines, stated to Mom felt tingly, hot and he collapsed onto floor. Bystanders heard his head hit onto the hard floor, one person thought his body shook. 911 called, BP WNL, PERL to light, oriented to person and place.  Able to speak, remained on floor with EMS volunteer holding neck still due to possible head trauma. Color pale back to pink quickly, no respiratory distress noted. EMS did transport to ER.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Activities of daily living impaired, Fatigue, Malaise
Clinical narrative: Malaise, exhaustion, missed work, symptoms lessened 2 days later but still present.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Severe pain at injection site, started immediately at time of injection.  Site continues to be very tender to touch and painful to move arm. Taking Ibuprofen and also recommended ice to area PRN.
Age: 59.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: Localized rash.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Blood culture negative, Computerised tomogram head normal, Delayed fontanelle closure, Infantile spitting up, Lumbar puncture normal
Clinical narrative: Had increased spitting up after vaccines. The day after vaccines mother noted that child had larger than normal anterior fontanelle. Parents took child to urgent care facility which sent child to ER for further management. Child had CT of head, LP, and septic work up. All is negative. Admitted and given vancomycin and ROCEPHIN. Discharged 07/31/2016.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Cellulitis, Erythema, Injection site pain, Peripheral swelling
Clinical narrative: Arm was actually sore starting the evening that the vaccine was administered.  Continued to be sore but didn't notice the severe erythema swelling until the morning of 8/5.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Cellulitis, Rash, Skin warm, Swelling, Tenderness
Clinical narrative: Arm was actually sore starting the evening that the vaccine was administered.  Continued to be sore but didn't notice the severe erythema swelling until the morning of 8/5.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Cellulitis, Erythema, Injection site pain, Peripheral swelling
Clinical narrative: Rash, swollen, tender, warm MD diagnosis: cellulitis.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Cellulitis, Rash, Skin warm, Swelling, Tenderness
Clinical narrative: Rash, swollen, tender, warm MD diagnosis: cellulitis.
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Dysphemia, Pyrexia
Clinical narrative: 7/16: onset of 3 days of fever 101-102 without other symptoms.  No rash. 7/18: stuttering, which has persisted without change.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Headache, Injection site bruising, Injection site discolouration, Injection site pruritus
Clinical narrative: Headache, nausea, dizziness, severe swelling on arm where vaccine administered, bruising, armpit swelled & turned black & blue under where vaccine administered, swelling still present 3 weeks later. Doctor gave steroid pack for treatment & also prescribed consistent icing of the site.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Lymphadenopathy, Nausea, Swelling
Clinical narrative: Headache, nausea, dizziness, severe swelling on arm where vaccine administered, bruising, armpit swelled & turned black & blue under where vaccine administered, swelling still present 3 weeks later. Doctor gave steroid pack for treatment & also prescribed consistent icing of the site.
Age: 88.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Peripheral swelling
Clinical narrative: Md advised Pharmacist that pt has cellulitis like swelling of right limb.
Age: 79.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Pain and redness at site extending 27-40 mm.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Abdominal discomfort, Chills, Headache, Oropharyngeal pain, Pain
Clinical narrative: About 5:30 PM patient was complaining of a sore throat and headache. By the time she went to bed at 10:00 PM it had worsened but included body aches. At 5:10 AM on 8/4/2016 she woke up with a headache, chills, body ache, sore throat, upset stomach and a 101 fever. Gave her Motrin which helped a bit and she was able to go back to sleep a few hours later. She was down all day and evening with the same symptoms. When she woke up on 8/5/2016 her condition greatly improved and she felt back to normal.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Pyrexia
Clinical narrative: About 5:30 PM patient was complaining of a sore throat and headache. By the time she went to bed at 10:00 PM it had worsened but included body aches. At 5:10 AM on 8/4/2016 she woke up with a headache, chills, body ache, sore throat, upset stomach and a 101 fever. Gave her Motrin which helped a bit and she was able to go back to sleep a few hours later. She was down all day and evening with the same symptoms. When she woke up on 8/5/2016 her condition greatly improved and she felt back to normal.
Age: 60.0
Sex: M
Vaccine: TDAP, VARZOS
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: Patient had ZOSTAVAX injection subcutaneously in her right arm and a BOOSTRIX injection intramuscularly in her left arm on 08/03/2016. On 08/05/2016 in the morning, she came into store to let us see the area where the ZOSTAVAX injection was given. The area was red, swollen and itchy. I explained that according to the vaccine information sheet that these are mild problems that can occur. She wanted to know what to do if the site got worse. I told her to call us and we would talk to her about it.
Age: 1.02
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Pyrexia, Rash erythematous, Vaccination complication
Clinical narrative: Started with a low grade fever and on 7/30/2016 the spots appeared in his belly. Low grade fever continued until 8/4/2016. He slept 15hrs straight and woke up with a bright red rash all over his body, along with more spots.
Age: 17.0
Sex: F
Vaccine: PPV
Symptoms: Hyperhidrosis, Oxygen saturation decreased, Respiratory distress
Clinical narrative: Severe respiratory distress, diaphoresis, drop in O2 sat. Required EPIPEN and EMS transport.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pain in extremity
Clinical narrative: Area around injection is large, red, and swollen, hot to the touch. Arm is also very sore.
Age: 80.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: Red rash around injection site. No treatment necessary.
Age: 59.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site nodule, Injection site pruritus, Injection site swelling
Clinical narrative: Customer said injection site developed a hard knot and later that night became red. The next day she began itching and it swelled up some.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Injection site pruritus, Injection site swelling, Injection site warmth, Peripheral coldness
Clinical narrative: Swelling and itching at injection site. 08/03/2016 12:00 PM continues heat and swelling at injection site and a few red splotches on face, 7:00 PM red hives on face and both arms 8:00 AM hives down both arms and legs stomach and back swollen arms and hands and toes starting to turn blue. Went to Asthma specialist who administered Zyrtec, Benadryl, and Prednisone with followup in hour and followup with MD on 08/05/2016 and specialist on 08/09/2016.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Peripheral swelling, Rash macular, Urticaria
Clinical narrative: Swelling and itching at injection site. 08/03/2016 12:00 PM continues heat and swelling at injection site and a few red splotches on face, 7:00 PM red hives on face and both arms 8:00 AM hives down both arms and legs stomach and back swollen arms and hands and toes starting to turn blue. Went to Asthma specialist who administered Zyrtec, Benadryl, and Prednisone with followup in hour and followup with MD on 08/05/2016 and specialist on 08/09/2016.
Age: 17.0
Sex: F
Vaccine: HPVX
Symptoms: Diarrhoea, Injection site bruising, Injection site pruritus, Injection site swelling
Clinical narrative: Diarrhea as well as swelling, itching and bruising at the injection site.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Blood test, Chronic fatigue syndrome, Eye pain, Feeling abnormal, Hypersomnia
Clinical narrative: Sleeps 18-20 hours a day, sharp pains in eyes, muscles hurt, brain fog, period issues and 2 strains of Lyme disease. Trying to treat Lyme but had many test and has Chronic Fatigue Syndrome.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Lyme disease, Menstrual disorder, Myalgia
Clinical narrative: Sleeps 18-20 hours a day, sharp pains in eyes, muscles hurt, brain fog, period issues and 2 strains of Lyme disease. Trying to treat Lyme but had many test and has Chronic Fatigue Syndrome.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Bronchoscopy, Chest pain, Dysphagia, Dyspnoea, Endoscopy
Clinical narrative: Trouble swallowing, chest pains, hard to breathe, muscle soreness. No treatment as no doctor can figure out what is wrong.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Myalgia, Pain, Weight decreased
Clinical narrative: Trouble swallowing, chest pains, hard to breathe, muscle soreness. No treatment as no doctor can figure out what is wrong.
Age: 75.0
Sex: F
Vaccine: PNC13
Symptoms: Asthenia, Eating disorder, Malaise, Pyrexia, Rash
Clinical narrative: Patient was fine on the day the vaccine was given, i.e. 08/01/2016. But on the next day towards afternoon, she started feeling sick. The patient stated that she had fever (she did not know how much). She was feeling very weak and not able to keep food down. At the same time her arm started developing a rash. The rash was not itchy but more painful. Patient has barely been able to eat since. She is feeling a little better today.
Sex: U
Vaccine: PPV
Symptoms: Vaccination failure
Clinical narrative: Information has been received from an unknown reporter regarding a patient of unknown age and gender who had enrolled in a Market Research program entitled "2016 Pneumovax Hospital Tracker 1110-Y935". The patient's concurrent condition, medical history and concomitant medication were unknown. On an unknown date, the patient was vaccinated with PNEUMOVAX23 (dose, frequency and route were not reported). In the "last 3 months", the reporter read that PNEUMOVAX23 was not as effective in lupus patients as was originally hoped (PT: vaccination failure). Action taken with the suspect vaccine was unknown. The outcome of vaccination failure was unknown. The reporter did not provide any causal relation between the event and PNEUMOVAX23. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Antibody test negative
Clinical narrative: Information has been received from a Nurse Practitioner (also reported as Nurse prescriber) concerning to a multiple unspecified patients of unknown age and gender. No pertinent medical history, drug reactions, allergies or concurrent conditions were reported. On unknown dates, the patients were vaccinated with unspecified doses of VARIVAX or with unspecified doses of M-M-R II (strength, dose, route of administration, frequency, lot number and expiration date were not provided). No concomitant medications were reported. On unknown dates, after receiving the unspecified number of doses of VARIVAX or M-M-R II, the patients had negative titers (antibody test negative). The outcome of the antibody test negative was unknown. The relatedness between the event and therapy with VARIVAX and M-M-R II were not reported. This is one of two reports received from the same reporter. Additional information has been requested.
Age: 2.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash generalised, Rash pruritic, Varicella post vaccine
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 2 year old male patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 08-JUL-2016, the patient was vaccinated with the first dose of VARIVAX (exact dose was not reported, subcutaneously, in the left thigh, lot # M003439, expiration date was not reported). The patient had pruritic bumps all over his body for three days and on 13-JUL-2016, he developed varicella. The outcome of varicella was reported as recovered/resolved on 22-JUL-2016. This is one of several reports from reporter. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Cerebrovascular accident, Herpes zoster, Ophthalmic herpes zoster
Clinical narrative: Information has been received from the patient's wife concerning her husband of unknown age. The patient's pertinent medical history and concurred conditions were not reported. In approximately 2011, reported as 5 years ago, the patient was vaccinated with ZOSTAVAX 19400 PFU, administered per subcutaneous route (lot #, expiration date and dose were not provided). The patient's wife reported that in approximately 2011, 5 years ago, her husband got shingles after vaccination with ZOSTAVAX and it spread to his eye and it eventually led to a stroke. It was also reported that on unspecified date the patient was treated by an ophthalmologist. The outcome of shingles and stroke was unknown at the time of the report. No product quality complaint (PQC) was involved. Upon internal review, the stroke (cerebrovascular accident) was determined to be medically significant. Additional information has been requested.
Sex: U
Vaccine: HEP, HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to 6 unspecified patients of unspecified demographics. On an unspecified dates, the patients received doses of improperly stored VAQTA with lot# M011116 and expiration date 17-MAY-2017 and RECOMBIVAX HB with lot# L033343 and expiration date 13-SEP-2017; both via intramuscular route. The excursions for both vaccines totaled 10 hours at 31 F. No adverse effect reported. No product complaint involved. No further information available. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Medical Assistant, referring to an unspecified number of patients of unknown age and gender. Information about the patient's pertinent medical history, concurrent conditions, concomitant therapies and drug reactions/allergies was not reported. On an unknown date, the patients were vaccinated with an improperly stored doses of GARDASIL 9 (lot number, expiration date, concentration, dose, route of administration and frequency were not reported). No adverse symptoms were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. Additional information has been requested.
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Dizziness, Injection site erythema, Injection site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Veteran reports 5/9 received pneum vaccine in PCP office- felt woozy then, the next day, shoulder/upper arm where received vaccine was red, slightly swollen, and hot to touch- not present currently, but is still tender near injection site. intermittent feelings of lightheadness with position changes, not falling.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Medical Assistant, referring to an unspecified number of patients of unknown age an gender. Information about the patients' pertinent medical history, concurrent conditions, concomitant therapies and drug reactions/allergies was not reported. On an unknown date, the patients were vaccinated with an improperly stored doses of M-M-R II (lot number, expiration date, concentration, dose, route of administration and frequency were not reported). No adverse symptoms were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected, as there was no permission to contact the physician.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to an unspecified number of patients. Pertinent medical history, allergies and drug reactions were not reported. ON 27-JUL-2016, the patients were vaccinated with an unspecified number of improperly stored doses of GARDASIL9 (lots # M006709, M0010440, M014926, expiry date 06-DEC-2018, 09-DEC-2018, 09-DEC-2018 and 17-FEB-2019 respectively) (lot numbers (lot number) are an invalid lot number GARDASIL9). The doses and routes of administration were not reported. At the same date no adverse effects were reported. Additional information has been requested.
Age: 0.04
Sex: U
Vaccine: RV5, HEP, RV5
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 15 day old patient. The patient pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On 15-JUL-2016, the patient received first dose of ROTATEQ (lot # M004508 and expiration date 29-JUN-2017) 2 ml, oral (Inappropriate age at vaccine administration). No adverse effects were reported. The patient also received second dose of RECOMBIVAX HB on the same day (captured in MARRS#1608USA001909). Additional information has been requested.
Age: 0.04
Sex: U
Vaccine: RV5, HEP, RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 15 day old patient. The patient pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On 15-JUL-2016, the patient received first dose of ROTATEQ (lot # M004508 and expiration date 29-JUN-2017) 2 ml, oral (Inappropriate age at vaccine administration). No adverse effects were reported. The patient also received second dose of RECOMBIVAX HB on the same day (captured in MARRS#1608USA001909). Additional information has been requested.
Age: 0.04
Sex: U
Vaccine: RV5, HEP, RV5
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 15 day old patient. The patient pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On 15-JUL-2016, the patient received second dose RECOMBIVAX HB (lot # L039660 and expiration date 04-FEB-2018) 0.5 ml, intramuscular (Inappropriate schedule of vaccine administered). No adverse effects were reported. The patient also received the first dose of ROTATEQ on the same day (captured in MARRS# 1608USA002793). Additional information has been requested.