chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site cellulitis, Injection site reaction, Injection site urticaria, Injection site warmth, Product quality issue
Clinical narrative: This case was reported by a physician (subject's father) and described the occurrence of injection site cellulitis in a child female subject who was vaccinated with KINRIX (GlaxoSmithKline). On an unspecified date, the subject received an unspecified dose of KINRIX (unknown route, unknown arm). Less than one month after vaccination with KINRIX, the subject experienced a small wheal an inch below the injection site. 2 weeks later, the subject experienced a hot, crusty 5 cm patch of cellulitis at injection site. It was nearly extending in size to her elbow. This case was associated to a product complaint since the reporter stated that he wondered if the adverse event was due to a 'bad batch' of KINRIX. This case was assessed as medically serious by GSK. The subject was treated with antibiotics. At the time of reporting, the outcomes of the events were unspecified.
Sex: F
Vaccine: DTAPIPV
Symptoms: Scab
Clinical narrative: This case was reported by a physician (subject's father) and described the occurrence of injection site cellulitis in a child female subject who was vaccinated with KINRIX (GlaxoSmithKline). On an unspecified date, the subject received an unspecified dose of KINRIX (unknown route, unknown arm). Less than one month after vaccination with KINRIX, the subject experienced a small wheal an inch below the injection site. 2 weeks later, the subject experienced a hot, crusty 5 cm patch of cellulitis at injection site. It was nearly extending in size to her elbow. This case was associated to a product complaint since the reporter stated that he wondered if the adverse event was due to a 'bad batch' of KINRIX. This case was assessed as medically serious by GSK. The subject was treated with antibiotics. At the time of reporting, the outcomes of the events were unspecified.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Gait disturbance, Local swelling, Pyrexia, Rash
Clinical narrative: My son started limping right after immunizations. Reaction was noticed the next morning at 2 a.m. with 101 degree fever. When he woke up later that morning, left leg was very swollen and covered with rash. Taken to walk-in clinic. Given Children's Benadryl Allergy and Cephalexin to take for 1 week (3 x per day).
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacist via sales representative refers to an unknown age and gender patient. Medical history was not reported. On an unknown date the patient was vaccinated with ZOSTAVAX lot number, expiration date, route and dosage were unknown. Concomitant therapy was unknown. The reporter informed that on an unknown date the patient had come down with shingle 3 or 4 days post vaccination with ZOSTAVAX. The patient sought unspecified medical attention. The patient's outcome with the event was unknown. Additional information has been requested.
Age: 1.13
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Injection site reaction, Rash, Rash vesicular
Clinical narrative: Truncal rash 7 days post MMR and vesicular rash at injection site due to VARIVAX.
Age: 49.0
Sex: M
Vaccine: TDAP
Symptoms: Decreased activity, Hypoaesthesia, Injection site anaesthesia, Injection site pain, Pain in extremity
Clinical narrative: Left arm and shoulder sore and numb x 2 weeks, used ibuprofen w/ relief, no redness, pt limited activity.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Burning sensation, Pain, Rash
Clinical narrative: Patient experienced a burning painful rash about the size of a dollar bill.
Age: 7.0
Sex: M
Vaccine: PPV
Symptoms: Abdominal pain, Swelling face, Vomiting
Clinical narrative: Vomiting, facial swelling and abdominal pain over a 12-18 hour period - received care in emergency department on 5/30/14 and had response to oral Decadron and Benadryl.
Age: 11.0
Sex: F
Vaccine: HEPA, MNQ, TDAP
Symptoms: Erythema, Swelling
Clinical narrative: This patient had a pretty large area of swelling and redness after her HPV. MODERATE REACTION.
Age: 11.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Arthralgia, Chest pain, Headache, Hypoaesthesia, Pain
Clinical narrative: Reports "brain pain", fever, chest pain and arm numbness following the vaccine. Reports today, 6-4-2014 joint pain in entire body, and numerous dr appts over the past 2 years, client did receive all 3 doses of HPV.
Age: 7.0
Sex: F
Vaccine: YF
Symptoms: Hypotonia, Pallor, Petit mal epilepsy, Staring, Unresponsive to stimuli
Clinical narrative: Patient was pale after administration of yellow fever vaccine. Patient sat in her Mother's lap. Per Dr. patient became limp, stared in space and was not responsive to Mother calling her name and had arm raised. Per Dr. this patient had a petit mal seizure.
Age: 66.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Induration, Local swelling, Upper extremity mass
Clinical narrative: My arm swelled, sore, painful huge lump in the arm the size of a tennis ball.  Require to take prednisone to aid.  Still have a hard lump in my right arm.
Age: 11.0
Sex: F
Vaccine: HPVX, MEN
Symptoms: Erythema, Local swelling, Pain, Pruritus, Pyrexia
Clinical narrative: Severe Swelling in the arm, Redness, Fever to the touch, itchy, painful, patient had fever. As of 5pm on the following day patient still has side effects and it is not getting better yet.
Age: 59.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Wrong drug administered
Clinical narrative: Pt was ordered to get Tdap vaccine at routine physical, but instead Kinrix was given by medical assistant.
Age: 2.0
Sex: F
Vaccine: PER, VARCEL
Symptoms: Crying, Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: Thigh very swollen. Very large welt. Extremely red area. Red area measured 2" x 2". Child kept awake at night crying about her leg hurting. Did this for three nights after receiving shot. Red swollen area lasted for about a month. Child complained of it hurting for about two weeks.
Age: 2.0
Sex: F
Vaccine: PER, VARCEL
Symptoms: Insomnia, Urticaria
Clinical narrative: Thigh very swollen. Very large welt. Extremely red area. Red area measured 2" x 2". Child kept awake at night crying about her leg hurting. Did this for three nights after receiving shot. Red swollen area lasted for about a month. Child complained of it hurting for about two weeks.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site induration, Local swelling, Skin warm
Clinical narrative: The patient reported to the pharmacy on 06/02/2014 that when she awoke on the morning of 5/28 her arm was significantly swollen, hot to the touch and there was a hardened circular area of skin surrounding the injection site. Upon inspection within the pharmacy the hardened skin was approximately 7cm in diameter. Her skin was still swollen but was lessening according to the patient. The edges of the swollen area were warm to the touch. This patient was referred to her physician.
Sex: F
Vaccine: FLUC3
Symptoms: Chills, Cough, Fatigue, Influenza, Influenza A virus test positive
Clinical narrative: Case number PHEH2014US005129 is an initial spontaneous report received from a consumer on 17 Feb 2014 with a combined follow-up received from a nurse and quality assurance department (QA reference number: 301042) on 21 May 2014 and 22 May 2014 respectively. This report refers to a female patient whose age was not reported. Her medical history and concomitant medications were not reported. She was vaccinated with FLUCELVAX (batch number: 004011A, expiry date: Jun 2014) in the right deltoid on 15 Oct 2013. It was reported that on 04 Feb 2014, she had type A flu and she took off on most of the week. She checked with her physician on 05 Feb 2014 with fever, chills, fatigue, cough and congestion. She was told that she tested positive for influenza type A. The event outcome, seriousness and causality were not reported. A batch investigation was requested for FLUCELVAX batch number: 004011A, with QA reference number 301042. Combined follow-up received from a nurse and quality assurance department on 21 May 2014 and 22 May 2014 respectively: updated date of vaccination, onset date of event, added event "vaccination failure" and QA reference number.
Sex: F
Vaccine: FLUC3
Symptoms: Pyrexia, Respiratory tract congestion, Vaccination failure
Clinical narrative: Case number PHEH2014US005129 is an initial spontaneous report received from a consumer on 17 Feb 2014 with a combined follow-up received from a nurse and quality assurance department (QA reference number: 301042) on 21 May 2014 and 22 May 2014 respectively. This report refers to a female patient whose age was not reported. Her medical history and concomitant medications were not reported. She was vaccinated with FLUCELVAX (batch number: 004011A, expiry date: Jun 2014) in the right deltoid on 15 Oct 2013. It was reported that on 04 Feb 2014, she had type A flu and she took off on most of the week. She checked with her physician on 05 Feb 2014 with fever, chills, fatigue, cough and congestion. She was told that she tested positive for influenza type A. The event outcome, seriousness and causality were not reported. A batch investigation was requested for FLUCELVAX batch number: 004011A, with QA reference number 301042. Combined follow-up received from a nurse and quality assurance department on 21 May 2014 and 22 May 2014 respectively: updated date of vaccination, onset date of event, added event "vaccination failure" and QA reference number.
Age: 1.0
Sex: M
Vaccine: FLU3, HEPA, HIBV, PNC13
Symptoms: Convulsion, Partial seizures, Pyrexia
Clinical narrative: Fever in 1st 12 hours, for 48-72 hrs up to 105 degrees. Seizure activity 6 days later. Still having brief partial seizures.
Age: 25.0
Sex: F
Vaccine: TDAP
Symptoms: Anxiety, Headache, Injection site pain, Injection site reaction, Musculoskeletal stiffness
Clinical narrative: HA, nausea, soreness/stiffness at injection site, "anxious and shaky". TX: ZOFRAN, Ibuprofen, TYLENOL, ice pack.
Age: 25.0
Sex: F
Vaccine: TDAP
Symptoms: Nausea, Nervousness
Clinical narrative: HA, nausea, soreness/stiffness at injection site, "anxious and shaky". TX: ZOFRAN, Ibuprofen, TYLENOL, ice pack.
Age: 53.0
Sex: F
Vaccine: TYP
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Local swelling, Musculoskeletal stiffness
Clinical narrative: Had left arm swelling, stiffness. Felt like she had swelling in LLE. ER did not report any documented LLE swelling.
Age: 16.0
Sex: F
Vaccine: TYP
Symptoms: Abdominal pain upper
Clinical narrative: Stomach ache
Age: 63.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling and redness over upper left arm. No s/s of infection.
Age: 64.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site haemorrhage, Injection site pain, Injection site swelling
Clinical narrative: Right upper arm with 4 x 4 cm swelling and erythema with ecchymosis. Tender to touch but good ROM. Heat compress at site and abx due to diabetes.
Age: 1.05
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Injection site reaction, Pyrexia, Rash maculo-papular
Clinical narrative: Fever 10d after injection. Papulomacular rash at injection site.
Age: 24.0
Sex: F
Vaccine: HEPA, MNQ, RAB
Symptoms: Injection site erythema, Injection site swelling, Nausea, Pruritus
Clinical narrative: Swelling, redness around the injection site of MENACTRA few hours after the vaccine. 2 days later pt reported nausea and itching.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Large (approximately 5 inches) rectangular red area, swollen, raised, red, warm, painful around injection site.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Wrong drug administered
Clinical narrative: Inadvertently administered MMRV and should have given MMR and VAR single antigen. This was because client had a history of seizures.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Redness, pain, swelling, warmth to skin at site of injection bil x 2d. 6 x 4cm (R); 4 x 4cm (L), 2 x 2 cm (L); no fever.
Age: 91.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Blood test, Pain, Rash generalised, Rash pruritic, Scab
Clinical narrative: This spontaneous report as received from a consumer refers to a 91 year old male patient reporting on himself. Pertinent medical history, drug reactions or allergies were not reported. On 17-OCT-2013, the patient was vaccinated with ZOSTAVAX, 1 injection (dose, route and lot # were not reported). Other suspect therapies included PNEUMOVAX 23 1 injection (dose, route and lot# were not reported) on the same date. Concomitant medication was not reported. On 17-OCT-2013, the patient received ZOSTAVAX and PNEUMOVAX 23 as "one injection". On the same date, the patient experienced a sore on the base of his neck and his physician told him not be concerned about it. On an unknown date, the patient went back and his physician decided to lance the sore with a frozen solution. The patient stated that he gradually developed a very painful and itchy rash all over his body except his face, hands, feet and groin area. At times the pain was excruciating. The patient stated that the rash on his neck and shoulders had crusted over. The physician told him the rash was not shingled and not scabies. The patient was treated with prednisone 10 mg tablet and cortisone cream. A blood work was performed (results were not provided). The patient sought medical attention. On 02-JUN-2014, the patient was feeling better than most days. The outcome of rash on his neck and shoulders had crusted over, very painful and itchy rash all over his body except his face, hands, feet and groin area and sore on the base of his neck was reported as not recovered. Causality was not reported. Additional information has been requested.
Age: 91.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Skin lesion, Wrong technique in drug usage process
Clinical narrative: This spontaneous report as received from a consumer refers to a 91 year old male patient reporting on himself. Pertinent medical history, drug reactions or allergies were not reported. On 17-OCT-2013, the patient was vaccinated with ZOSTAVAX, 1 injection (dose, route and lot # were not reported). Other suspect therapies included PNEUMOVAX 23 1 injection (dose, route and lot# were not reported) on the same date. Concomitant medication was not reported. On 17-OCT-2013, the patient received ZOSTAVAX and PNEUMOVAX 23 as "one injection". On the same date, the patient experienced a sore on the base of his neck and his physician told him not be concerned about it. On an unknown date, the patient went back and his physician decided to lance the sore with a frozen solution. The patient stated that he gradually developed a very painful and itchy rash all over his body except his face, hands, feet and groin area. At times the pain was excruciating. The patient stated that the rash on his neck and shoulders had crusted over. The physician told him the rash was not shingled and not scabies. The patient was treated with prednisone 10 mg tablet and cortisone cream. A blood work was performed (results were not provided). The patient sought medical attention. On 02-JUN-2014, the patient was feeling better than most days. The outcome of rash on his neck and shoulders had crusted over, very painful and itchy rash all over his body except his face, hands, feet and groin area and sore on the base of his neck was reported as not recovered. Causality was not reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This spontaneous report as received from a consumer refers to a female patient of unknown age reporting on herself. Pertinent medical history, drug reaction or allergies were not reported. On approximately May 2014, reported as "a week and half ago", the patient was vaccinated with ZOSTAVAX dose 1 (route and lot # were not reported). Concomitant therapy was not reported. In approximately 2014, the patient's arm was sore. The outcome of arm was sore was unknown. Causality was not reported. Additional information is not expected.
Age: 5.0
Sex: F
Vaccine: DTAP, MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling and redness to right deltoid. No fever or chills. Gradual onset of symptoms. Treatment - Ice area for 20 minutes 3-4 times/day.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain, Pyrexia
Clinical narrative: Patient reports to clinic with a red, circular area surrounding the injection site. Presents with low grade fever and complains of burning sensation to that particular area. No C/P, SOB, abd. pain, N/V/D or s/s. TX: BACTRIM 40mg/200mg/5ml po (susp.). Take 15 ml bid po x 5 days. RTC in 2 days for recheck. Dx: cellulitis of upper (R) limb.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to unspecified patients (demographics unknown). Pertinent medical history, drug reactions or allergies were not reported. On an unknown date, the patients were vaccinated with PEDVAXHIB (dose, route and lot# were not reported) which was exposed to -1C for 22 days. The nurse stated that she was not sure doses may had been administered to patients. No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Immediate post-injection reaction, Injection site mass
Clinical narrative: This spontaneous report was received from a physician, via a company representative, concerning 1 year old female patient. Medical history and concurrent conditions were not reported. On an unknown date the patient was vaccinated with a dose of (Oka/Merck) VARIVAX (doses, lot number, expiration date, strength and route were not reported) in the leg. Concomitant therapies included VAQTA and PREVENAR 13. The reporter stated an patient received (Oka/Merck) VARIVAX on an unspecified date, and experienced a lump at the injection site on her leg immediately following. At the time of the report the outcome was reported as recovered. Additional information is not expected.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Contusion, Laceration, Road traffic accident
Clinical narrative: Patient left the store after the shot and rode his motorcycle. He got in a wreck and woke up in the hospital. He doesn't remember anything after leaving the store. He sustained cuts to the face and bruises. He had his helmet on.
Age: 14.0
Sex: M
Vaccine: HPV4
Symptoms: Dizziness, Formication, Hallucination, Increased upper airway secretion, Lethargy
Clinical narrative: Woke up with sore throat - increased phlegm, lethargic and dizzy - later that night had hallucination. Skin crawl - ran out into street with traffic lasted about 10-15 mins. - went to ER next morning. No tx - seen in office 6/2 for follow up. Symptoms cleared.
Age: 14.0
Sex: M
Vaccine: HPV4
Symptoms: Oropharyngeal pain
Clinical narrative: Woke up with sore throat - increased phlegm, lethargic and dizzy - later that night had hallucination. Skin crawl - ran out into street with traffic lasted about 10-15 mins. - went to ER next morning. No tx - seen in office 6/2 for follow up. Symptoms cleared.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: 5-30-14 diagnosis of varicella.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Injection site discolouration, Injection site nodule, Rash, Rash erythematous
Clinical narrative: Injection site rxn after a few days - that lasted 3 weeks - large knot and bluish purple color - discoloration still visible. Fine red vesicular rash around neck and on chest - felt chapped with small blisters. No fever, nausea, headache. Resolved with hydrocortisone and BENADRYL - minor discoloration visible at injection site.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash vesicular, Skin fissures
Clinical narrative: Injection site rxn after a few days - that lasted 3 weeks - large knot and bluish purple color - discoloration still visible. Fine red vesicular rash around neck and on chest - felt chapped with small blisters. No fever, nausea, headache. Resolved with hydrocortisone and BENADRYL - minor discoloration visible at injection site.
Sex: F
Vaccine: HPV4
Symptoms: Lymphadenopathy
Clinical narrative: This spontaneous report as received from a nurse practitioner via company representative refers to a female patient of unknown age. In May 2012 the patient was vaccinated with influenza virus vaccine (manufacturer unknown) and experienced supraclavicular nodes (case number 1405USA013174). In May 2013 the patient was vaccinated with FLUMIST and experienced supraclavicular nodes again. On an unknown date the patient was vaccinated with GARDASIL first dose (route, lot and expiration date not reported) for prevention of HPV and experienced the same adverse event, supraclavicular nodes. At the time of the report the outcome of developed supraclavicular nodes was unknown. The patient sought medical attention. This is one of two reports from the same reporter. (1405USA013174). Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with the (Oka/Merck) VARIVAX (lot# and expiration date not provided) (dose not reported). On an unknown date the patient received dose of (Oka/Merck) VARIVAX that was exposed to temperature above the recommended temperature range. No adverse effect was reported. This is one of several reports from the same reporter (Same Reporter Link: MARRS#1405USA015420, MARRS#1405USA015421, MARRS#1405USA015422, MARRS#1405USA015423). Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified patient (demographics unknown). Pertinent medical history, drug reactions or allergies were not reported. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (dose, route and lot# were not reported) which this single dose was exposed to -1C for 22 days. The nurse stated that she was not sure if dose may had been administered to the patient. No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Varicella
Clinical narrative: This spontaneous report as received from a 51 year old female patient with a degenerative spine condition, reporting on herself. There were no pertinent medical history and no drug reactions or allergies. On an unspecified date in December 2013 the patient was vaccinated with ZOSTAVAX injection, dose 1 (strength, lot#, expiration date and route not reported). Concomitant therapies included unspecified anesthetics for a degenerative spine condition. On an unspecified date in January 2014, the patient experienced chickenpox and on an unspecified date in May 2014 the patient experienced shingles. No treatment was given. No laboratories diagnostic test were performed. At the moment of the report, the outcome of shingles and chickenpox was unknown. The patient did not seek medical attention. No further relevant medical data were provided. Additional information is not expected.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to unspecified patients (demographics unknown). Pertinent medical history, drug reactions or allergies were not reported. On an unknown date, the patient were vaccinated with RECOMBIVAX HB (dose, route and lot# were not reported) which was exposed to -1C for 22 days. The nurse stated that she was not sure doses may had been administered to patients. No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
Age: 40.0
Sex: F
Vaccine: TDAP
Symptoms: Blood test normal, Muscular weakness, Musculoskeletal pain, Pain, Pain in extremity
Clinical narrative: 2/4/14 - 8:00 AM - felt soreness with movement, no localized reaction. About 4 wk later went to PCP -> thought had hurt herself - sore shoulder and arm. XRay and blood work all neg. End of March had medical message - no relief. 5/15/2014 - (R) upper arm examined no redness, no swelling, nothing felt at site, no pain site, painful with movement at site - unable to pick up grocery bag with right arm, feels weak. 6/4/2014 - symptoms continues.
Age: 40.0
Sex: F
Vaccine: TDAP
Symptoms: X-ray normal
Clinical narrative: 2/4/14 - 8:00 AM - felt soreness with movement, no localized reaction. About 4 wk later went to PCP -> thought had hurt herself - sore shoulder and arm. XRay and blood work all neg. End of March had medical message - no relief. 5/15/2014 - (R) upper arm examined no redness, no swelling, nothing felt at site, no pain site, painful with movement at site - unable to pick up grocery bag with right arm, feels weak. 6/4/2014 - symptoms continues.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: ZOSTAVAX: 6-1-14; reaction started 6-3-14. Redness at injection site. Warm to touch at site. Area of reaction across deltoid region. TYLENOL/IBU OTC recommend.
Age: 19.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Erythema, Pruritus, Urticaria
Clinical narrative: "Started about midnight, used Ibuprofen then itching and hives showed up - I took BENADRYL. That cleared it by Friday night or Sat. morning" so lasted from 5-29 to 5-30-14. Red raised welts with itching. States completely resolved. No further symptoms.
Age: 10.0
Sex: M
Vaccine: MNQ, TDAP, MNQ, TDAP
Symptoms: Cellulitis, Erythema, Induration, Injection site erythema, Injection site swelling
Clinical narrative: Seen 6/3/14 with cellulitis weepy, red swollen (R) arm put on BACTRIM (allergy to amox) came in 6/4/14 with massive cellulitis - sent to ER (red, hot, swollen elbow to deltoid). (L) arm today 3 x 3 cm erythema, sl firm.
Age: 10.0
Sex: M
Vaccine: MNQ, TDAP, MNQ, TDAP
Symptoms: Injection site warmth, Local swelling, Secretion discharge
Clinical narrative: Seen 6/3/14 with cellulitis weepy, red swollen (R) arm put on BACTRIM (allergy to amox) came in 6/4/14 with massive cellulitis - sent to ER (red, hot, swollen elbow to deltoid). (L) arm today 3 x 3 cm erythema, sl firm.
Age: 10.0
Sex: M
Vaccine: MNQ, TDAP, MNQ, TDAP
Symptoms: Cellulitis, Erythema, Induration, Local swelling, Secretion discharge
Clinical narrative: Seen 6/3/14 with cellulitis weepy, red swollen (R) arm put on BACTRIM (allergy to amox) came in 6/4/14 with massive cellulitis - sent to ER (red, hot, swollen elbow to deltoid). (L) arm today 3 x 3 cm erythema, sl firm.
Age: 10.0
Sex: M
Vaccine: MNQ, TDAP, MNQ, TDAP
Symptoms: Skin warm
Clinical narrative: Seen 6/3/14 with cellulitis weepy, red swollen (R) arm put on BACTRIM (allergy to amox) came in 6/4/14 with massive cellulitis - sent to ER (red, hot, swollen elbow to deltoid). (L) arm today 3 x 3 cm erythema, sl firm.
Age: 2.0
Sex: F
Vaccine: DTAP
Symptoms: Abnormal behaviour, Headache, Injection site movement impairment, Injection site reaction, Insomnia
Clinical narrative: 30 min after admin. pt was taking her doll and hitting head against the wall. Never done before, usually gets upset if she drops her doll. Grumpy part of the day post immunization. H/A started and lasted through next day. Mom tx w/ orals. Back of neck sensitive, esp (R) side. Woke up q 30-60 min. Slept on mom's chest but still waking up. Didn't want to use her leg, wouldn't bend x 2 days. Knot in muscle where injection given. Temp 101.9 degrees. Mom requested events be reported.
Age: 2.0
Sex: F
Vaccine: DTAP
Symptoms: Irritability, Tenderness
Clinical narrative: 30 min after admin. pt was taking her doll and hitting head against the wall. Never done before, usually gets upset if she drops her doll. Grumpy part of the day post immunization. H/A started and lasted through next day. Mom tx w/ orals. Back of neck sensitive, esp (R) side. Woke up q 30-60 min. Slept on mom's chest but still waking up. Didn't want to use her leg, wouldn't bend x 2 days. Knot in muscle where injection given. Temp 101.9 degrees. Mom requested events be reported.
Age: 1.57
Sex: F
Vaccine: DTAPHEPBIP, FLU3, HEPA, HIBV, MMRV, PNC13
Symptoms: Abnormal behaviour, Body temperature increased, Cow's milk intolerance, Feeling abnormal, Food allergy
Clinical narrative: Low grade temp of 99 for 24 hours. "Not himself", irritable. Extremely hyper active day after vaccinations which she has never been before. Nonstop moving her arms/legs, jabbering nonstop, unable to sit still. Randomly will scream for no reason. Headaches. Defiant. Decreased po. On 18th reported chicken pox like rash. That showed up 10 days post immunizations. Itchy raised red spots, no blisters. Mom believes vaccines caused wheat intolerance and milk intolerance and the above sx and would like events reported.
Age: 1.57
Sex: F
Vaccine: DTAPHEPBIP, FLU3, HEPA, HIBV, MMRV, PNC13
Symptoms: Headache, Hypophagia, Irritability, Logorrhoea, Psychomotor hyperactivity
Clinical narrative: Low grade temp of 99 for 24 hours. "Not himself", irritable. Extremely hyper active day after vaccinations which she has never been before. Nonstop moving her arms/legs, jabbering nonstop, unable to sit still. Randomly will scream for no reason. Headaches. Defiant. Decreased po. On 18th reported chicken pox like rash. That showed up 10 days post immunizations. Itchy raised red spots, no blisters. Mom believes vaccines caused wheat intolerance and milk intolerance and the above sx and would like events reported.
Age: 1.57
Sex: F
Vaccine: DTAPHEPBIP, FLU3, HEPA, HIBV, MMRV, PNC13
Symptoms: Rash erythematous, Rash pruritic, Rash vesicular, Screaming
Clinical narrative: Low grade temp of 99 for 24 hours. "Not himself", irritable. Extremely hyper active day after vaccinations which she has never been before. Nonstop moving her arms/legs, jabbering nonstop, unable to sit still. Randomly will scream for no reason. Headaches. Defiant. Decreased po. On 18th reported chicken pox like rash. That showed up 10 days post immunizations. Itchy raised red spots, no blisters. Mom believes vaccines caused wheat intolerance and milk intolerance and the above sx and would like events reported.
Age: 16.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Eyelid ptosis, Headache, Lacrimation increased, Pain in extremity, Pain in jaw
Clinical narrative: April 3, patient stubbed toe and received 1st Tdap vaccine. On April 28 patient went to the doctor for a school assessment and received a Tdap and a second vaccine (unknown which kind). On April 29 patient awoke with acute onset of weakness, unable to get out of bed. Family felt like her jaw was stuck closed and unable to open, and she was unable to smile. After that day, her symptoms improved, and except for upper back and shoulder pain, she was largely asymptomatic. On 5/5/14, patient had another acute worsening of symptoms. She was unable to stand on her feet nor walk, and needed help even getting up and down from the toilet. Parents noted she spoke slowly and quietly, again without opening her jaw much. On admission to PICU on 5/6/14, patient was noted to have absent gag, significant proximal LE and UE weakness, hyporeflexia, and a waddling gait. She was initially monitored with neuro checks and initially q2 hour NIFs given concern for potential respiratory compromise that were subsequently spaced as they remained stable. Work up for progressive neuromuscular weakness was significant for CSF with albuminocytologic dissociation, normal MRI brain and c-spine, normal WBC, CRP, and EMG-NCS with evidence of nerve demyelination. Overall most consistent with a variant of acute inflammatory, polyradiculoneuropathy (aka Guillain-Barre syndrome). Based on EMG findings she was started on daily IVIG 0.5g/kg for total of 4 doses on 5/6-5/9.
Age: 16.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Swelling face, Trismus, VIIth nerve paralysis
Clinical narrative: April 3, patient stubbed toe and received 1st Tdap vaccine. On April 28 patient went to the doctor for a school assessment and received a Tdap and a second vaccine (unknown which kind). On April 29 patient awoke with acute onset of weakness, unable to get out of bed. Family felt like her jaw was stuck closed and unable to open, and she was unable to smile. After that day, her symptoms improved, and except for upper back and shoulder pain, she was largely asymptomatic. On 5/5/14, patient had another acute worsening of symptoms. She was unable to stand on her feet nor walk, and needed help even getting up and down from the toilet. Parents noted she spoke slowly and quietly, again without opening her jaw much. On admission to PICU on 5/6/14, patient was noted to have absent gag, significant proximal LE and UE weakness, hyporeflexia, and a waddling gait. She was initially monitored with neuro checks and initially q2 hour NIFs given concern for potential respiratory compromise that were subsequently spaced as they remained stable. Work up for progressive neuromuscular weakness was significant for CSF with albuminocytologic dissociation, normal MRI brain and c-spine, normal WBC, CRP, and EMG-NCS with evidence of nerve demyelination. Overall most consistent with a variant of acute inflammatory, polyradiculoneuropathy (aka Guillain-Barre syndrome). Based on EMG findings she was started on daily IVIG 0.5g/kg for total of 4 doses on 5/6-5/9.
Age: 16.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Abasia, Activities of daily living impaired, Areflexia, Asthenia, Back pain
Clinical narrative: April 3, patient stubbed toe and received 1st Tdap vaccine. On April 28 patient went to the doctor for a school assessment and received a Tdap and a second vaccine (unknown which kind). On April 29 patient awoke with acute onset of weakness, unable to get out of bed. Family felt like her jaw was stuck closed and unable to open, and she was unable to smile. After that day, her symptoms improved, and except for upper back and shoulder pain, she was largely asymptomatic. On 5/5/14, patient had another acute worsening of symptoms. She was unable to stand on her feet nor walk, and needed help even getting up and down from the toilet. Parents noted she spoke slowly and quietly, again without opening her jaw much. On admission to PICU on 5/6/14, patient was noted to have absent gag, significant proximal LE and UE weakness, hyporeflexia, and a waddling gait. She was initially monitored with neuro checks and initially q2 hour NIFs given concern for potential respiratory compromise that were subsequently spaced as they remained stable. Work up for progressive neuromuscular weakness was significant for CSF with albuminocytologic dissociation, normal MRI brain and c-spine, normal WBC, CRP, and EMG-NCS with evidence of nerve demyelination. Overall most consistent with a variant of acute inflammatory, polyradiculoneuropathy (aka Guillain-Barre syndrome). Based on EMG findings she was started on daily IVIG 0.5g/kg for total of 4 doses on 5/6-5/9.
Age: 16.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: C-reactive protein abnormal, CSF test abnormal, Demyelination, Dysstasia, Electromyogram abnormal
Clinical narrative: April 3, patient stubbed toe and received 1st Tdap vaccine. On April 28 patient went to the doctor for a school assessment and received a Tdap and a second vaccine (unknown which kind). On April 29 patient awoke with acute onset of weakness, unable to get out of bed. Family felt like her jaw was stuck closed and unable to open, and she was unable to smile. After that day, her symptoms improved, and except for upper back and shoulder pain, she was largely asymptomatic. On 5/5/14, patient had another acute worsening of symptoms. She was unable to stand on her feet nor walk, and needed help even getting up and down from the toilet. Parents noted she spoke slowly and quietly, again without opening her jaw much. On admission to PICU on 5/6/14, patient was noted to have absent gag, significant proximal LE and UE weakness, hyporeflexia, and a waddling gait. She was initially monitored with neuro checks and initially q2 hour NIFs given concern for potential respiratory compromise that were subsequently spaced as they remained stable. Work up for progressive neuromuscular weakness was significant for CSF with albuminocytologic dissociation, normal MRI brain and c-spine, normal WBC, CRP, and EMG-NCS with evidence of nerve demyelination. Overall most consistent with a variant of acute inflammatory, polyradiculoneuropathy (aka Guillain-Barre syndrome). Based on EMG findings she was started on daily IVIG 0.5g/kg for total of 4 doses on 5/6-5/9.
Age: 16.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Gait disturbance, Guillain-Barre syndrome, Hyporeflexia, Immunoglobulin therapy, Incorrect dose administered
Clinical narrative: April 3, patient stubbed toe and received 1st Tdap vaccine. On April 28 patient went to the doctor for a school assessment and received a Tdap and a second vaccine (unknown which kind). On April 29 patient awoke with acute onset of weakness, unable to get out of bed. Family felt like her jaw was stuck closed and unable to open, and she was unable to smile. After that day, her symptoms improved, and except for upper back and shoulder pain, she was largely asymptomatic. On 5/5/14, patient had another acute worsening of symptoms. She was unable to stand on her feet nor walk, and needed help even getting up and down from the toilet. Parents noted she spoke slowly and quietly, again without opening her jaw much. On admission to PICU on 5/6/14, patient was noted to have absent gag, significant proximal LE and UE weakness, hyporeflexia, and a waddling gait. She was initially monitored with neuro checks and initially q2 hour NIFs given concern for potential respiratory compromise that were subsequently spaced as they remained stable. Work up for progressive neuromuscular weakness was significant for CSF with albuminocytologic dissociation, normal MRI brain and c-spine, normal WBC, CRP, and EMG-NCS with evidence of nerve demyelination. Overall most consistent with a variant of acute inflammatory, polyradiculoneuropathy (aka Guillain-Barre syndrome). Based on EMG findings she was started on daily IVIG 0.5g/kg for total of 4 doses on 5/6-5/9.
Age: 16.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Intensive care, Mobility decreased, Muscular weakness, Musculoskeletal pain, Nerve conduction studies abnormal
Clinical narrative: April 3, patient stubbed toe and received 1st Tdap vaccine. On April 28 patient went to the doctor for a school assessment and received a Tdap and a second vaccine (unknown which kind). On April 29 patient awoke with acute onset of weakness, unable to get out of bed. Family felt like her jaw was stuck closed and unable to open, and she was unable to smile. After that day, her symptoms improved, and except for upper back and shoulder pain, she was largely asymptomatic. On 5/5/14, patient had another acute worsening of symptoms. She was unable to stand on her feet nor walk, and needed help even getting up and down from the toilet. Parents noted she spoke slowly and quietly, again without opening her jaw much. On admission to PICU on 5/6/14, patient was noted to have absent gag, significant proximal LE and UE weakness, hyporeflexia, and a waddling gait. She was initially monitored with neuro checks and initially q2 hour NIFs given concern for potential respiratory compromise that were subsequently spaced as they remained stable. Work up for progressive neuromuscular weakness was significant for CSF with albuminocytologic dissociation, normal MRI brain and c-spine, normal WBC, CRP, and EMG-NCS with evidence of nerve demyelination. Overall most consistent with a variant of acute inflammatory, polyradiculoneuropathy (aka Guillain-Barre syndrome). Based on EMG findings she was started on daily IVIG 0.5g/kg for total of 4 doses on 5/6-5/9.
Age: 16.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Nuclear magnetic resonance imaging brain normal, Nuclear magnetic resonance imaging spinal normal, Trismus, White blood cell count normal
Clinical narrative: April 3, patient stubbed toe and received 1st Tdap vaccine. On April 28 patient went to the doctor for a school assessment and received a Tdap and a second vaccine (unknown which kind). On April 29 patient awoke with acute onset of weakness, unable to get out of bed. Family felt like her jaw was stuck closed and unable to open, and she was unable to smile. After that day, her symptoms improved, and except for upper back and shoulder pain, she was largely asymptomatic. On 5/5/14, patient had another acute worsening of symptoms. She was unable to stand on her feet nor walk, and needed help even getting up and down from the toilet. Parents noted she spoke slowly and quietly, again without opening her jaw much. On admission to PICU on 5/6/14, patient was noted to have absent gag, significant proximal LE and UE weakness, hyporeflexia, and a waddling gait. She was initially monitored with neuro checks and initially q2 hour NIFs given concern for potential respiratory compromise that were subsequently spaced as they remained stable. Work up for progressive neuromuscular weakness was significant for CSF with albuminocytologic dissociation, normal MRI brain and c-spine, normal WBC, CRP, and EMG-NCS with evidence of nerve demyelination. Overall most consistent with a variant of acute inflammatory, polyradiculoneuropathy (aka Guillain-Barre syndrome). Based on EMG findings she was started on daily IVIG 0.5g/kg for total of 4 doses on 5/6-5/9.
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site nodule, Injection site pruritus
Clinical narrative: This spontaneous report as received from a registered nurse via a company representative refers to a 59 year old female patient. On 14-MAY-2014 the patient was vaccinated with ZOSTAVAX (one shot vaccination, strength, dose and lot # was not reported), injection. On 15-MAY-2014, the patient's injection site was "very red, extremely itchy, raised, and hot to the touch." The patient visited a nurse for medical attention, and the injection site was "warm to the touch, still very red, very itchy, and still raised to 8cm x 11cm." Corticosteroid cream was applied, and the patient was advised to take antihistamine as soon as possible. The outcome of the adverse events was reported as not recovered/not resolved. Additional information has been requested.
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a registered nurse via a company representative refers to a 59 year old female patient. On 14-MAY-2014 the patient was vaccinated with ZOSTAVAX (one shot vaccination, strength, dose and lot # was not reported), injection. On 15-MAY-2014, the patient's injection site was "very red, extremely itchy, raised, and hot to the touch." The patient visited a nurse for medical attention, and the injection site was "warm to the touch, still very red, very itchy, and still raised to 8cm x 11cm." Corticosteroid cream was applied, and the patient was advised to take antihistamine as soon as possible. The outcome of the adverse events was reported as not recovered/not resolved. Additional information has been requested.
Sex: U
Vaccine: RV5, RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse. The reporter reported that at an unspecified physician office, VAQTA, RECOMBIVAX and GARDASIL were exposed to 33F for 70 temperature excursions which totaled 1173 hours out of range. She stated that during this time, these doses might have been administered to an unspecified number of patients. No adverse effects reported. The reporter stated she did not have any patient information. The reporter stated that at a different unspecified physician's office ROTATEQ, VAQTA, RECOMBIVAX and GARDASIL were exposed to 34F for 317 hours (13 days) and then they were exposed to 48F for 63 hours. The reporter stated that these doses might have been administered to an unspecified number of patients. No adverse effects reported. This is one of several reports received from the same source (Other MARRS#1405USA013967, 1405USA013971, 1405USA010115, 1405USA013970, 1405USA013966 and 1405USA013968). All telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested.
Sex: U
Vaccine: RV5, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse. The reporter reported that at an unspecified physician office, VAQTA, RECOMBIVAX and GARDASIL were exposed to 33F for 70 temperature excursions which totaled 1173 hours out of range. She stated that during this time, these doses might have been administered to an unspecified number of patients. No adverse effects reported. The reporter stated she did not have any patient information. The reporter stated that at a different unspecified physician's office ROTATEQ, VAQTA, RECOMBIVAX and GARDASIL were exposed to 34F for 317 hours (13 days) and then they were exposed to 48F for 63 hours. The reporter stated that these doses might have been administered to an unspecified number of patients. No adverse effects reported. This is one of several reports received from the same source (Other MARRS#1405USA013967, 1405USA013971, 1405USA010115, 1405USA013970, 1405USA013966 and 1405USA013968). All telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested.
Age: 13.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Syncope
Clinical narrative: This spontaneous report as received from a nurse refers to a 13 year old male patient. On 30-MAY-2014 the patient was vaccinated with his first dose of GARDASIL, 0.5 ml, intramuscularly (lot # not reported). The nurse reported to her that the patient fainted 10 minutes after receiving his first dose of GARDASIL. She reports that the nurse stated that the patient recovered without treatment on 30-MAY-2014. Additional information has been requested.
Age: 7.0
Sex: M
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Pyrexia, Vaccination site pain, Vaccination site rash
Clinical narrative: Rash and pain in area of vaccination in left arm along with fever to 102  Fever lasted only on 6/3/14. Seen in office by reported on 6/4/14. Refusing to use left arm. Rx with Ibuprofen.
Age: 41.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site swelling, Pain
Clinical narrative: Swelling, pain and redness at injection site (Upper arm) as well as spreading onto the clavicle area, posterior shoulder, mid-upper arm.
Age: 41.0
Sex: F
Vaccine: PPV
Symptoms: Swelling
Clinical narrative: Swelling, pain and redness at injection site (Upper arm) as well as spreading onto the clavicle area, posterior shoulder, mid-upper arm.
Age: 66.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Chills, Decreased appetite, Erythema, Fatigue, Headache
Clinical narrative: Fatigue, headache, chills, slight fever, swelling and redness, loss of appetite.
Age: 66.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Pain, Pyrexia, Swelling
Clinical narrative: Fatigue, headache, chills, slight fever, swelling and redness, loss of appetite.
Age: 66.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Chills, Cough, Decreased appetite, Depression, Fatigue
Clinical narrative: Fatigue, headache, chills, slight fever, swelling and redness, loss of appetite.
Age: 66.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Fatigue, headache, chills, slight fever, swelling and redness, loss of appetite.
Age: 66.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Throat irritation
Clinical narrative: Fatigue, headache, chills, slight fever, swelling and redness, loss of appetite.