chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 46.0
Sex: M
Vaccine: HEPA
Symptoms: Blood test, Chronic fatigue syndrome, Rheumatoid factor
Clinical narrative: I experienced the symptoms of chronic fatigue syndrome after receiving the vaccine. The symptoms have not abated. This seems to be a permanent, and untreatable condition.
Age: 1.36
Sex: F
Vaccine: HIBV, VARCEL
Symptoms: Erythema, Pyrexia
Clinical narrative: Almost immediate fever to 102.1 within 5 minutes of vaccination and turned red -- no urticaria, no facial swelling, no difficulty breathing.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Headache
Clinical narrative: Severe headache.
Age: 5.0
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Injection site erythema, Injection site mass, Injection site warmth
Clinical narrative: Baseball sized lump on right thigh at immunization location site. Bright red, warm to touch.
Age: 3.0
Sex: M
Vaccine: MMR
Symptoms: Chest X-ray, Ear infection, Febrile convulsion, Pneumonia viral, Pyrexia
Clinical narrative: Fever spiked up to 102 degrees and then he had a febrile seizure that lasted 2 minutes.  Taken to local ER and told he had a small ear infection and minor viral pneumonia.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Dermatitis, Erythema, Injection site pruritus, Pruritus generalised
Clinical narrative: States redness and itching started Nov 7th on (R) arm at site of influenza vaccine (received Nov 6 2013) and gradually spread down arm, across torso to entire body. 11/19/2013: Dermatitis, perhaps reactive (pt mentioned that this started just distal to flu vaccine site): SOLU-MEDROL IM. Prednisone taper. Topical steroid. Antihistamine. Instructed pt to call if not improved. Methylprednisolone 125 mg once, Prednisone taper (70mg to 10mg) over 7 da mg every day, diphenhydramine 25 mg PRN.
Age: 12.0
Sex: M
Vaccine: FLU3, HPV4, MNQ, TDAP
Symptoms: Abdominal pain, Pain in extremity, Pallor, Rash, Rash macular
Clinical narrative: Phone call received from pt father reports - abdominal pain and severe bilat arm pain on 2/17 and 2/18. Rash to bilateral arms and legs started on 2/20 - pt seen at walk in clinic on 2/21/14 by Dr. Described rash as blanching pink macular lace like rash - with viral exanthem. Talked to pt's step mom today 2/24/14 pt is at school and the rash is going away - no abdominal discomfort.
Age: 12.0
Sex: M
Vaccine: FLU3, HPV4, MNQ, TDAP
Symptoms: Viral rash
Clinical narrative: Phone call received from pt father reports - abdominal pain and severe bilat arm pain on 2/17 and 2/18. Rash to bilateral arms and legs started on 2/20 - pt seen at walk in clinic on 2/21/14 by Dr. Described rash as blanching pink macular lace like rash - with viral exanthem. Talked to pt's step mom today 2/24/14 pt is at school and the rash is going away - no abdominal discomfort.
Age: 1.13
Sex: M
Vaccine: FLU3, HEPA, MMR, VARCEL
Symptoms: Full blood count normal, Pain, Rash erythematous, Rash maculo-papular, Rash pruritic
Clinical narrative: 12d post vaccination (MMR/VAR/HAV/INL) developed erythematous maculopapular rash mostly face/arms/legs - pruritic sore very discretely umbilicated/scabbed.
Age: 1.13
Sex: M
Vaccine: FLU3, HEPA, MMR, VARCEL
Symptoms: Scab, Urine analysis normal
Clinical narrative: 12d post vaccination (MMR/VAR/HAV/INL) developed erythematous maculopapular rash mostly face/arms/legs - pruritic sore very discretely umbilicated/scabbed.
Age: 26.0
Sex: F
Vaccine: TDAP
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Received Tdap x 2 1/5/14 and 1/23/14. No adverse reaction noted or known.
Age: 22.0
Sex: F
Vaccine: TDAP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: None noted or known reaction. Received Tdap x 2 10/2/13 and 1/23/14.
Age: 20.0
Sex: F
Vaccine: TDAP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Pt. received Tdap x 2 9/30/13, 12/27/13. Reaction: None noted or known.
Age: 23.0
Sex: F
Vaccine: TDAP
Symptoms: Incorrect dose administered
Clinical narrative: Tdap x 2 2/5/14 and 2/20/14. None noted or known reaction.
Age: 20.0
Sex: F
Vaccine: TDAP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Pt. received Tdap x 2 in short time frame. No known adverse reactions. Received on 1/23/14 and 2/6/14.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Contusion, Erythema, Skin warm
Clinical narrative: Redness, hot to touch, bruise.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Autoimmune disorder, Injection site pain, Musculoskeletal pain, Pruritus
Clinical narrative: A day following the injection the patient experienced a twinging pain in the shoulder that then started to spread from her rt shoulder to her left shoulder. It continued to spread to her hip and tailbone and started to itch and scratch excessively. The patient saw her MD and he surmised that she is having an autoimmune response to the vaccine. Her started her prednisone.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Headache, Herpes zoster, Local swelling, Musculoskeletal pain, Pain in extremity
Clinical narrative: A day following the injection the patient experienced a twinging pain in the shoulder that then started to spread from her rt shoulder to her left shoulder. It continued to spread to her hip and tailbone and started to itch and scratch excessively. The patient saw her MD and he surmised that she is having an autoimmune response to the vaccine. Her started her prednisone.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pruritus, Rash generalised
Clinical narrative: A day following the injection the patient experienced a twinging pain in the shoulder that then started to spread from her rt shoulder to her left shoulder. It continued to spread to her hip and tailbone and started to itch and scratch excessively. The patient saw her MD and he surmised that she is having an autoimmune response to the vaccine. Her started her prednisone.
Age: 63.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site nodule, Pain in extremity
Clinical narrative: Boostrix admin on 2/27/14. Injection site was visibly reddened. Upon touch there was a hard nodule. Soreness was still in the arm. Advised patient to take Benadryl, Ibu, Tylenol.
Sex: F
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: This consumer report (initial receipt 24-Feb-2014) concerns a female patient. On an unspecified date, the patient received an unspecified flu vaccine (manufacturer and batch number not reported). On an unspecified date, the patient developed a reaction which included getting the flu after vaccination. Outcome was not reported.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Abortion spontaneous, Exposure during pregnancy, Inappropriate schedule of drug administration, Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a 19 year old female consumer, for GARDASIL a Pregnancy Registry product, with no drug reactions/allergies and a history of breaking her arm twice who in approximately 2007 was vaccinated with the first dose of GARDASIL (Lot# and route not reported) and the second dose of GARDASIL (Lot# and route not reported) while she was pregnant. There was no concomitant medication. The patient stated that in approximately 2007 (about 5 years ago) she received the first GARDASIL injection and experienced some redness and swelling at the injection site. After receiving the second injection of the GARDASIL she realized that she had received the product while she was pregnant. The patient did not remember the dates she received either GARDASIL injection. The patient sought unspecified medical attention. No treatment was given. The patient's pregnancy had been confirmed by pregnancy test. Her last LMP was on 17-NOV-2011. Expected date of delivery was 23-AUG-2012. At the time of the report, the patient had not recovered yet. Follow up information was received from a Registered Nurse on 27-FEB-2014. The reporter stated that the patient had a miscarriage. The patient was still at the practice. Upon internal review, spontaneous abortion was considered to be medically significant event. Additional information is not expected.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Pregnancy test positive
Clinical narrative: Information has been received from a 19 year old female consumer, for GARDASIL a Pregnancy Registry product, with no drug reactions/allergies and a history of breaking her arm twice who in approximately 2007 was vaccinated with the first dose of GARDASIL (Lot# and route not reported) and the second dose of GARDASIL (Lot# and route not reported) while she was pregnant. There was no concomitant medication. The patient stated that in approximately 2007 (about 5 years ago) she received the first GARDASIL injection and experienced some redness and swelling at the injection site. After receiving the second injection of the GARDASIL she realized that she had received the product while she was pregnant. The patient did not remember the dates she received either GARDASIL injection. The patient sought unspecified medical attention. No treatment was given. The patient's pregnancy had been confirmed by pregnancy test. Her last LMP was on 17-NOV-2011. Expected date of delivery was 23-AUG-2012. At the time of the report, the patient had not recovered yet. Follow up information was received from a Registered Nurse on 27-FEB-2014. The reporter stated that the patient had a miscarriage. The patient was still at the practice. Upon internal review, spontaneous abortion was considered to be medically significant event. Additional information is not expected.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This spontaneous report as received from a consumer of 77 year old with osteoporosis concerning herself. Patient had no other drug allergic reaction previously. On an unknown date of 2005, the patient was vaccinated with ZOSTAVAX (strength, dose unit, route, lot# and expiry date unknown) 1 time vaccine in her left arm to prevent shingles. Concomitant therapies included FOSAMAX. On an unknown date of 2005, the patient experienced pain and tenderness at the site of insertion after receiving the ZOSTAVAX vaccine. She was a participant in a clinical trial for ZOSTAVAX. Patient did not sought medical attention and no treatment was provided to the events. The outcome of pain and tenderness at the site of insertion was unknown. No other information was reported. Additional information has been requested.
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Blister, Exposure during pregnancy, Purulence, Urticaria, Wheezing
Clinical narrative: Case number PHHY2013US147468, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 509083) website on 16 Dec 2013 and a follow up information was received on 24 Feb 2014. This report refers to a pregnant female patient. She was vaccinated with H1N1 influenza vaccine (manufacturer and batch number: not reported. Hence, conservatively coded as Pandemic influenza vaccine INN) on 01 Oct 2009. It was reported that during vaccination she was 8 months pregnant. On an unknown date, two to three days after vaccination the patient developed wheezing, urticaria and pus filled blisters. The patient was treated in the emergency room with BENADRYL, corticosteroids and Albuterol. The patient had no illness at the time of vaccination. The outcome of the pregnancy was unknown. The outcome of the events was reported as recovered. The seriousness and causality of the events were not reported. Reporter was anonymous and therefore due diligence cannot be pursued. Multiple follow-ups were attempted but no response was received from the reporter. Hence the case was closed due to lack of response. Follow up information received on 24 Feb 2014: Information about lost to follow up was updated.
Age: 23.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Dyspnoea, Flushing, Immediate post-injection reaction
Clinical narrative: This case was reported by a healthcare professional (physician's assistant) and described the occurrence of shortness of breath in a 23-year-old female subject who was vaccinated with FLULAVAL TETRA (GlaxoSmithKline). Concurrent medications included Norgestimate + oestradiol. On 1 December 2013 the subject received a dose of FLULAVAL TETRA (1 dose, unknown details). On 1 December 2013, immediately after vaccination with FLULAVAL TETRA , the subject experienced shortness of breath, flushing and lightheadedness. The healthcare professional considered the events were life threatening and clinically significant (or requiring intervention). The subject was treated with Epinephrine "immediately" and the symptoms resolved. The subject was followed up at the emergency room. On 1 December 2013, the events were resolved. The healthcare professional considered the events were possibly related to vaccination with FLULAVAL TETRA.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Erythema, Influenza like illness, Lethargy, Pyrexia
Clinical narrative: This spontaneous report as received from a registered nurse (R.N.) refers to herself. The R.N. reported that in November of 2013 she received ZOSTAVAX (lot number and expiration date unknown) and approximately 2 weeks later (in approximately 2013), experienced chills, lethargy, and a high temperature which lasted for approximately 3 days. After the R.N.'s "fever broke she experienced a chicken pox like rash on her chest and abdomen." On 03-FEB-2014, the patient had a mild case of the flu, and was sick for approximately 4 days (on approximately 06-FEB-2014). On 08-FEB-2014, the patient had "a chicken pox like rash on her abdomen and chest." That patient had recovered from all events. This is one of several reports received from the same source (linked report number: 1312USA008840). Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash, Rash pruritic, Varicella
Clinical narrative: This spontaneous report as received from a registered nurse (R.N.) refers to herself. The R.N. reported that in November of 2013 she received ZOSTAVAX (lot number and expiration date unknown) and approximately 2 weeks later (in approximately 2013), experienced chills, lethargy, and a high temperature which lasted for approximately 3 days. After the R.N.'s "fever broke she experienced a chicken pox like rash on her chest and abdomen." On 03-FEB-2014, the patient had a mild case of the flu, and was sick for approximately 4 days (on approximately 06-FEB-2014). On 08-FEB-2014, the patient had "a chicken pox like rash on her abdomen and chest." That patient had recovered from all events. This is one of several reports received from the same source (linked report number: 1312USA008840). Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Influenza, Lethargy, Malaise, Pyrexia
Clinical narrative: This spontaneous report as received from a registered nurse (R.N.) refers to herself. The R.N. reported that in November of 2013 she received ZOSTAVAX (lot number and expiration date unknown) and approximately 2 weeks later (in approximately 2013), experienced chills, lethargy, and a high temperature which lasted for approximately 3 days. After the R.N.'s "fever broke she experienced a chicken pox like rash on her chest and abdomen." On 03-FEB-2014, the patient had a mild case of the flu, and was sick for approximately 4 days (on approximately 06-FEB-2014). On 08-FEB-2014, the patient had "a chicken pox like rash on her abdomen and chest." That patient had recovered from all events. This is one of several reports received from the same source (linked report number: 1312USA008840). Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash, Rash vesicular
Clinical narrative: This spontaneous report as received from a registered nurse (R.N.) refers to herself. The R.N. reported that in November of 2013 she received ZOSTAVAX (lot number and expiration date unknown) and approximately 2 weeks later (in approximately 2013), experienced chills, lethargy, and a high temperature which lasted for approximately 3 days. After the R.N.'s "fever broke she experienced a chicken pox like rash on her chest and abdomen." On 03-FEB-2014, the patient had a mild case of the flu, and was sick for approximately 4 days (on approximately 06-FEB-2014). On 08-FEB-2014, the patient had "a chicken pox like rash on her abdomen and chest." That patient had recovered from all events. This is one of several reports received from the same source (linked report number: 1312USA008840). Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Computerised tomogram, Eye inflammation, Laboratory test, Nuclear magnetic resonance imaging, Papilloedema
Clinical narrative: Floaters in eyes noticed 11/14/13, vision problem by 12/17/13. Saw eye MD 12/17, CT of head, MRI's done 12/7-12/20 after papilledema Dx - all neg. Neurologist did lumbar puncture - neg. Given pred IV in hosp 12/20-21. Cont optic nerve swelling - 2/5/14 - acyclovir tried. Cont vision loss currently.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Retinal exudates, Tumour marker test, Visual impairment, Vitreous floaters
Clinical narrative: Floaters in eyes noticed 11/14/13, vision problem by 12/17/13. Saw eye MD 12/17, CT of head, MRI's done 12/7-12/20 after papilledema Dx - all neg. Neurologist did lumbar puncture - neg. Given pred IV in hosp 12/20-21. Cont optic nerve swelling - 2/5/14 - acyclovir tried. Cont vision loss currently.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Retinal exudates, Visual impairment, Vitreous floaters
Clinical narrative: Floaters in eyes noticed 11/14/13, vision problem by 12/17/13. Saw eye MD 12/17, CT of head, MRI's done 12/7-12/20 after papilledema Dx - all neg. Neurologist did lumbar puncture - neg. Given pred IV in hosp 12/20-21. Cont optic nerve swelling - 2/5/14 - acyclovir tried. Cont vision loss currently.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Blindness, Blood test, Computerised tomogram head, Lumbar puncture normal, Nuclear magnetic resonance imaging brain
Clinical narrative: Floaters in eyes noticed 11/14/13, vision problem by 12/17/13. Saw eye MD 12/17, CT of head, MRI's done 12/7-12/20 after papilledema Dx - all neg. Neurologist did lumbar puncture - neg. Given pred IV in hosp 12/20-21. Cont optic nerve swelling - 2/5/14 - acyclovir tried. Cont vision loss currently.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Papilloedema, Visual impairment, Vitreous floaters
Clinical narrative: Floaters in eyes noticed 11/14/13, vision problem by 12/17/13. Saw eye MD 12/17, CT of head, MRI's done 12/7-12/20 after papilledema Dx - all neg. Neurologist did lumbar puncture - neg. Given pred IV in hosp 12/20-21. Cont optic nerve swelling - 2/5/14 - acyclovir tried. Cont vision loss currently.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Alanine aminotransferase increased, B-lymphocyte count, Blindness, Blood albumin normal, Blood bilirubin increased
Clinical narrative: Floaters in eyes noticed 11/14/13, vision problem by 12/17/13. Saw eye MD 12/17, CT of head, MRI's done 12/7-12/20 after papilledema Dx - all neg. Neurologist did lumbar puncture - neg. Given pred IV in hosp 12/20-21. Cont optic nerve swelling - 2/5/14 - acyclovir tried. Cont vision loss currently.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Blood creatine phosphokinase MB, CSF cell count normal, CSF glucose normal, CSF oligoclonal band, CSF protein normal
Clinical narrative: Floaters in eyes noticed 11/14/13, vision problem by 12/17/13. Saw eye MD 12/17, CT of head, MRI's done 12/7-12/20 after papilledema Dx - all neg. Neurologist did lumbar puncture - neg. Given pred IV in hosp 12/20-21. Cont optic nerve swelling - 2/5/14 - acyclovir tried. Cont vision loss currently.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: CSF test, Chest X-ray, Computerised tomogram, Electrocardiogram normal, Eye pain
Clinical narrative: Floaters in eyes noticed 11/14/13, vision problem by 12/17/13. Saw eye MD 12/17, CT of head, MRI's done 12/7-12/20 after papilledema Dx - all neg. Neurologist did lumbar puncture - neg. Given pred IV in hosp 12/20-21. Cont optic nerve swelling - 2/5/14 - acyclovir tried. Cont vision loss currently.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Headache, Hypertension, Inflammation, International normalised ratio normal, Iritis
Clinical narrative: Floaters in eyes noticed 11/14/13, vision problem by 12/17/13. Saw eye MD 12/17, CT of head, MRI's done 12/7-12/20 after papilledema Dx - all neg. Neurologist did lumbar puncture - neg. Given pred IV in hosp 12/20-21. Cont optic nerve swelling - 2/5/14 - acyclovir tried. Cont vision loss currently.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Laboratory test, Lymphocyte percentage decreased, Maculopathy, Mean cell haemoglobin increased, Monocyte percentage
Clinical narrative: Floaters in eyes noticed 11/14/13, vision problem by 12/17/13. Saw eye MD 12/17, CT of head, MRI's done 12/7-12/20 after papilledema Dx - all neg. Neurologist did lumbar puncture - neg. Given pred IV in hosp 12/20-21. Cont optic nerve swelling - 2/5/14 - acyclovir tried. Cont vision loss currently.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Neutrophil count normal, Neutrophil percentage increased, Nuclear magnetic resonance imaging normal, Optic neuritis, Papilloedema
Clinical narrative: Floaters in eyes noticed 11/14/13, vision problem by 12/17/13. Saw eye MD 12/17, CT of head, MRI's done 12/7-12/20 after papilledema Dx - all neg. Neurologist did lumbar puncture - neg. Given pred IV in hosp 12/20-21. Cont optic nerve swelling - 2/5/14 - acyclovir tried. Cont vision loss currently.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Photophobia, Protein total normal, Prothrombin time, Pterygium, Retinopathy
Clinical narrative: Floaters in eyes noticed 11/14/13, vision problem by 12/17/13. Saw eye MD 12/17, CT of head, MRI's done 12/7-12/20 after papilledema Dx - all neg. Neurologist did lumbar puncture - neg. Given pred IV in hosp 12/20-21. Cont optic nerve swelling - 2/5/14 - acyclovir tried. Cont vision loss currently.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Tumour marker test, Vision blurred, Visual impairment, Vitreous floaters
Clinical narrative: Floaters in eyes noticed 11/14/13, vision problem by 12/17/13. Saw eye MD 12/17, CT of head, MRI's done 12/7-12/20 after papilledema Dx - all neg. Neurologist did lumbar puncture - neg. Given pred IV in hosp 12/20-21. Cont optic nerve swelling - 2/5/14 - acyclovir tried. Cont vision loss currently.
Age: 59.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Chills, Headache, Influenza like illness, Injection site erythema, Irritability
Clinical narrative: This spontaneous report as received from a physician refers to a 59 year old male patient with chronic hepatitis C. There were no drug reactions/allergies. On 13-FEB-2014 the patient was vaccinated with the first dose of PNEUMOVAX 23, lot# reported J011799, 0.5 ml, intramuscular in the left arm. On 14-FEB-2014 the patient developed severe headache, chills, malaise, and myalgia. On 15-FEB-2014, patient developed severe pain and redness of the left arm, starting from inferior to the injection site extending to the left elbow. No lab diagnostics studies performed. The patient sought medical attention via calling physician. The patient was advised to take unspecified anti-inflammatory medication, increase fluid intake, and bedrest. The patient's symptoms were improving slowly at the time of the report. Additional information has been requested.
Age: 59.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Malaise, Pyrexia, Tenderness
Clinical narrative: This spontaneous report as received from a physician refers to a 59 year old male patient with chronic hepatitis C. There were no drug reactions/allergies. On 13-FEB-2014 the patient was vaccinated with the first dose of PNEUMOVAX 23, lot# reported J011799, 0.5 ml, intramuscular in the left arm. On 14-FEB-2014 the patient developed severe headache, chills, malaise, and myalgia. On 15-FEB-2014, patient developed severe pain and redness of the left arm, starting from inferior to the injection site extending to the left elbow. No lab diagnostics studies performed. The patient sought medical attention via calling physician. The patient was advised to take unspecified anti-inflammatory medication, increase fluid intake, and bedrest. The patient's symptoms were improving slowly at the time of the report. Additional information has been requested.
Age: 59.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Chills, Headache, Injection site erythema, Injection site pain, Malaise
Clinical narrative: This spontaneous report as received from a physician refers to a 59 year old male patient with chronic hepatitis C. There were no drug reactions/allergies. On 13-FEB-2014 the patient was vaccinated with the first dose of PNEUMOVAX 23, lot# reported J011799, 0.5 ml, intramuscular in the left arm. On 14-FEB-2014 the patient developed severe headache, chills, malaise, and myalgia. On 15-FEB-2014, patient developed severe pain and redness of the left arm, starting from inferior to the injection site extending to the left elbow. No lab diagnostics studies performed. The patient sought medical attention via calling physician. The patient was advised to take unspecified anti-inflammatory medication, increase fluid intake, and bedrest. The patient's symptoms were improving slowly at the time of the report. Additional information has been requested.
Age: 59.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Myalgia
Clinical narrative: This spontaneous report as received from a physician refers to a 59 year old male patient with chronic hepatitis C. There were no drug reactions/allergies. On 13-FEB-2014 the patient was vaccinated with the first dose of PNEUMOVAX 23, lot# reported J011799, 0.5 ml, intramuscular in the left arm. On 14-FEB-2014 the patient developed severe headache, chills, malaise, and myalgia. On 15-FEB-2014, patient developed severe pain and redness of the left arm, starting from inferior to the injection site extending to the left elbow. No lab diagnostics studies performed. The patient sought medical attention via calling physician. The patient was advised to take unspecified anti-inflammatory medication, increase fluid intake, and bedrest. The patient's symptoms were improving slowly at the time of the report. Additional information has been requested.
Age: 0.35
Sex: F
Vaccine: HIBV, RVX
Symptoms: Constipation
Clinical narrative: Constipation. Previously 2-3 bowel movements/day. After regular 4 mo vaccinations 9 days of constipation then 1 bowel movement, then 6 more days constipation then treated with suppository. Continued constipation at this point.
Age: 1.29
Sex: F
Vaccine: HIBV, MMR
Symptoms: Erythema, Hypersensitivity, Pruritus, Rash morbilliform, Urticaria
Clinical narrative: Within 24 hours I noticed my daughter had hives around her mouth and on her back. We gave her some Benadryl and they went away. 24 hours later they returned so we repeated the Benadryl. 6-8 hours later the hives returned along with a measles-like rash that started around her neck and spread down her abdomen. I contacted the after hours line at her pediatricians office and was told to continue Benadryl and seek medical attention. The next day my daughter woke up with hives, the measles-like rash and this time the back of her head and neck were bright red and she was scratching at it. The symptoms increased over a course of 3-4 days. We took her to urgent care and they prescribed confirmed that it was an allergic reaction to the MMR vaccination and they prescribed some medicine. It took about 24 hours for the medication to kick in and after that her symptoms decreased. Within 48 hours the rash and hives were more or less gone.
Age: 34.0
Sex: F
Vaccine: FLUX
Symptoms: Arthralgia, Musculoskeletal pain, Pain
Clinical narrative: My left shoulder became extremely painful to move, especially to take a shirt off over my head.  Any rotation of the shoulder joint was painful.  NSAIDS did not much to help with the pain and the pain was worse at night.
Age: 17.0
Sex: F
Vaccine: HEPA, HPV4, MEN
Symptoms: Exposure during pregnancy, Injection site pain, Pregnancy test positive
Clinical narrative: Information has been received from a 17 year old female patient with drug allergy to DIFLUCAN and LORABID and amoxicillin allergy and with no pertinent medical history, for HPV rL1 6 11 16 18, a Pregnancy Registry product, who on 15-MAY-2012 was vaccinated with a dose of HPV rL1 6 11 16 18 (lot # not reported). Secondary suspect therapy included a dose of hepatitis A virus vaccine inactivated (manufacturer unknown) (lot # not reported) at the same doctor visit. Concomitant therapy included a dose of meningococcal vaccine (unspecified) (lot # not reported) at the same doctor visit. On an unspecified date in May 2012, the patient took 5 pregnancy tests at home which showed that she was pregnant. Last menstrual period (LMP) was on 17-APR-2012 and the estimated delivery date (EDD) was on 22-JAN-2013. On 15-MAY-2012 the patient experienced injection sites hurt for a day or so, but the pain was "now: gone. The patient had sought medical attention by visiting the doctor. Follow-up was received from a registered nurse stating that the patient's hospital record stated that the baby appeared in good health. The last date that the patient had an appointment was in May 2012. The patient never came in to the office following birth. Additional information is not expected.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No medical history or concurrent conditions were reported. On 25-FEB-2014 the patient was vaccinated with PNEUMOVAX 23 (lot # H009826, 0.5 ml, intramuscular). It was reported that the patient received an expired dose of PNEUMOVAX 23 as the expiration date was 11-FEB-2014. No symptoms were reported. No further details were provided. Additional information is not expected.
Age: 38.0
Sex: F
Vaccine: MMR
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The pharmacist reported that the patient was administered a M-M-R II series on an unspecified dates when was younger (doses, route and lot numbers not provided); however they did not have documentation of these vaccinations. On 27-JAN-2014 the patient was at the pharmacy and the pharmacist would be administering a dose of M-M-R II (dose, route and lot number not provided). No adverse effects were reported. Follow up information as received from the pharmacist refers to the approximately 38 year old female patient. The patient was unsure whether or not she received M-M-R II in the past. She had immigrated and she did not have a vaccination record. The pharmacist administered one dose of M-M-R II on 27-JAN-2014. Additional information is not expected.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Wrong technique in drug usage process
Clinical narrative: This spontaneous report as received from a physician refers to a 72 year old female patient. On an unknown date in 2012 (reported as about 2 years ago) the patient was vaccinated with a dose of ZOSTAVAX. Concomitantly the patient used cholesterol medications and hypertension medications (both unspecified). Prior to being administered, ZOSTAVAX was heated in the microwave. On 03-MAR-2014 the patient presented to the physician's office with shingles. The patient was prescribed VALTREX and ZOVIRAX ointment to treat the symptoms. The outcome of shingles was reported as not recovered/not resolved. No causality assessment was provided. Additional information has been requested.
Age: 28.0
Sex: F
Vaccine: VARCEL
Symptoms: Headache, Musculoskeletal stiffness, Photophobia
Clinical narrative: Severe headache, stiff neck, photophobia.
Age: 1.47
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Apnoea, Chest X-ray, Cough, Laboratory test abnormal, Pertussis
Clinical narrative: Initial report received on 24 February 2014 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis disease in a 4 year-old male subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received 3 doses of PENTACEL; lot number C3397AB received on 29 July 2009, lot number CC3436AB received on 29 September 2009 and lot number C3545AA received on 30 November 2009 and 1 dose of TRIPEDIA; lot number C3545AA received on 15 November 2010 (routes and sites of administration not reported). On 02 February 2014, the subject developed a cough and paroxysmal cough without a whoop. The subject also experienced sleep disturbance without apnea. Laboratory testing included positive PCR on 14 February 2014. Chest x-ray findings were unknown. Corrective treatments consisted of azithromycin starting on 14 February 2014 for 5 days. The subject was not hospitalized. At the time of final contact on 16 February 2014, the subject's cough was still persisting. The duration of the cough was reported at that time as 14 days. According to the investigator, this case was epidemiologically linked to a laboratory confirmed case. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 1.47
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Polymerase chain reaction, Sleep disorder
Clinical narrative: Initial report received on 24 February 2014 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis disease in a 4 year-old male subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received 3 doses of PENTACEL; lot number C3397AB received on 29 July 2009, lot number CC3436AB received on 29 September 2009 and lot number C3545AA received on 30 November 2009 and 1 dose of TRIPEDIA; lot number C3545AA received on 15 November 2010 (routes and sites of administration not reported). On 02 February 2014, the subject developed a cough and paroxysmal cough without a whoop. The subject also experienced sleep disturbance without apnea. Laboratory testing included positive PCR on 14 February 2014. Chest x-ray findings were unknown. Corrective treatments consisted of azithromycin starting on 14 February 2014 for 5 days. The subject was not hospitalized. At the time of final contact on 16 February 2014, the subject's cough was still persisting. The duration of the cough was reported at that time as 14 days. According to the investigator, this case was epidemiologically linked to a laboratory confirmed case. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 1.0
Sex: F
Vaccine: HEPA, MMRV
Symptoms: Exposure to communicable disease, Varicella post vaccine
Clinical narrative: This spontaneous report as received from a physician via the representative refers to a 13 month old female patient with no pertinent medical history. On 20-DEC-2013 the patient was vaccinated with a dose of PROQUAD (Merck) (lot # and expiration date not reported), 1 injection. Concomitant therapies included HAVRIX which was given at the same time to PROQUAD (Merck). On 14-FEB-2014, the patient developed chicken-pox, after being vaccinated with PROQUAD (Merck). The chicken pox rash was on the patient's face and diaper area, and rash was less than 50 lesions. In addition, the patient, after getting PROQUAD (Merck), was exposed to chicken pox at her day-care. The patient was taken to physician to seek medical attention. No treatment was given for adverse event. No lab diagnostics studies were performed. The patient was recovered on an unspecified date. 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 an unspecified number of patients of unknown age who on an unknown dates, were vaccinated with an unspecified number of doses of VARIVAX (doses, route and lot numbers not reported) that were exposed to a first excursion of -12C for 15 hours on 17-FEB-2014 and then an additional excursion of -12C for 19.5 hours beginning on 01-MAR-2014 which were supported as long as the overall average temperature remained between -50C and -15C. No adverse events were reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age who on an unknown dates, were vaccinated with an unspecified number of doses of VAQTA (doses, routes and lot numbers not reported) that were exposed to 20C for 15 hours on 17-FEB-2014 and an additional excursion of 14C for 19.5 hours beginning on 01-MAR-2014 which was supported. No adverse events were reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age who on an unknown dates, were vaccinated with an unspecified number of doses of ROTATEQ (doses, routes and lot numbers not reported) that were exposed to 20C for 15 hours on 17-FEB-2014 and an additional excursion of 14C for 19.5 hours beginning on 01-MAR-2014 which was supported. No adverse events were reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age who on an unknown dates, were vaccinated with an unspecified number of doses of PROQUAD (Merck) (doses, routes and lot numbers not reported) that were exposed to a first excursion of -12C for 15 hours on 17-FEB-2014 and then an additional excursion of -12C for 19.5 hours beginning on 01-MAR-2014 which were supported as long as the overall average temperature remained between -50C and -15C. No adverse events were reported. This is one of several reports from the same source. Additional information has been requested.
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 an unspecified number of patients of unknown age who on an unknown dates, were vaccinated with an unspecified number of doses of RECOMBIVAX HB (doses, routes and lot numbers not reported) that were exposed to 20C for 15 hours on 17-FEB-2014 and an additional excursion of 14C for 19.5 hours beginning on 01-MAR-2014 which was supported. No adverse events were reported. This is one of several reports from the same source. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Local swelling, Pain in extremity, Rash, Rash erythematous
Clinical narrative: 2/22/14 pt went to ER with swelling in arm (+) pain. 2/28/14 redness not improved, red itchy bumps on torso, chest.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Rash pruritic
Clinical narrative: 2/22/14 pt went to ER with swelling in arm (+) pain. 2/28/14 redness not improved, red itchy bumps on torso, chest.
Age: 50.0
Sex: F
Vaccine: HEP, MMR, TDAP, VARCEL
Symptoms: Arthralgia, Fatigue, Injected limb mobility decreased, Injection site erythema, Injection site mass
Clinical narrative: After getting the vaccines on 3/2/2014 12:00 pm, the left arm area of injection varicella site swollen redness, lump and warm to touch difficult to lift arm feels heavy and sore, joints ache, generalized itchiness, stiff neck, exhausted all the time, just wants to sleep. Per provider recipient monitor left arm site and if worsening of symptoms to return to clinic.
Age: 50.0
Sex: F
Vaccine: HEP, MMR, TDAP, VARCEL
Symptoms: Injection site swelling, Injection site warmth, Musculoskeletal stiffness, Pain in extremity, Pruritus generalised
Clinical narrative: After getting the vaccines on 3/2/2014 12:00 pm, the left arm area of injection varicella site swollen redness, lump and warm to touch difficult to lift arm feels heavy and sore, joints ache, generalized itchiness, stiff neck, exhausted all the time, just wants to sleep. Per provider recipient monitor left arm site and if worsening of symptoms to return to clinic.
Age: 50.0
Sex: F
Vaccine: HEP, MMR, TDAP, VARCEL
Symptoms: Sensation of heaviness, Somnolence, Tuberculin test
Clinical narrative: After getting the vaccines on 3/2/2014 12:00 pm, the left arm area of injection varicella site swollen redness, lump and warm to touch difficult to lift arm feels heavy and sore, joints ache, generalized itchiness, stiff neck, exhausted all the time, just wants to sleep. Per provider recipient monitor left arm site and if worsening of symptoms to return to clinic.
Sex: U
Vaccine: HIBV, HPV4, PPV, RV5, TD
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse (RN) refers to an unspecified number of patients of unknown age and gender. The patients' medical history and concurrent medications were not provided. It was reported that the unspecified number of patients were administered doses of GARDASIL, PNEUMOVAX23, ROTATEQ, PEDVAXHIB and VACCIN TD that were exposed to temperatures outside of the prescribing information which could not be supported on unspecified dates since 07-FEB-2014. No adverse events were reported. Additional information has been requested.
Age: 54.0
Sex: M
Vaccine: FLU3
Symptoms: Hypoaesthesia, Laboratory test, Muscular weakness, Pain in extremity, Pyrexia
Clinical narrative: Initial report received on 25-FEB-2014 from a consumer (the patient's wife): A 54-year-old male patient with no illness at time of vaccination and no pre-existing medical conditions had received an intramuscular injection of FLUZONE (Sanofi Pasteur Inc., batch number not reported) in the left deltoid in OCT-2013. 10 days after vaccination, in OCT-2013, the patient presented with fever and was seen in the MD office. The diagnosis was sinusitis. He was put on steroids for 1 week. He then developed pain, numbness, and weakness in the upper and lower extremities. He was seen by a Neurologist who made the diagnosis of "FLUZONE reaction". It has been 4 months since the vaccine was administered and the patient was still having symptoms. There has been some improvement in the lower extremities, but he is still having symptoms in the upper extremities. Many tests were run but specific information was not provided. At the time of the report, the outcome was mentioned as "not recovered".
Age: 54.0
Sex: M
Vaccine: FLU3
Symptoms: Sinusitis, Vaccination complication
Clinical narrative: Initial report received on 25-FEB-2014 from a consumer (the patient's wife): A 54-year-old male patient with no illness at time of vaccination and no pre-existing medical conditions had received an intramuscular injection of FLUZONE (Sanofi Pasteur Inc., batch number not reported) in the left deltoid in OCT-2013. 10 days after vaccination, in OCT-2013, the patient presented with fever and was seen in the MD office. The diagnosis was sinusitis. He was put on steroids for 1 week. He then developed pain, numbness, and weakness in the upper and lower extremities. He was seen by a Neurologist who made the diagnosis of "FLUZONE reaction". It has been 4 months since the vaccine was administered and the patient was still having symptoms. There has been some improvement in the lower extremities, but he is still having symptoms in the upper extremities. Many tests were run but specific information was not provided. At the time of the report, the outcome was mentioned as "not recovered".
Age: 0.3
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC13
Symptoms: Anxiety, Cyanosis, Dyspnoea, Laboratory test normal
Clinical narrative: Initial case received from a physician on 26 February 2014. A four-month old patient, with no reported medical history or concomitant medications, received the following intramuscular vaccines in February 2014: ACTHIB, DAPTACEL, IPOL, and PREVENAR (Pfizer); lot numbers, sites of vaccination, and number of previous doses were not reported. According to the reporter, the patient experienced breathing difficulties and "turned blue" approximately three hours post-vaccination. He was brought to the emergency room and underwent unspecified testing, all of which was normal. He was diagnosed with anxiety and discharged from the emergency room the same day. The patient had been seen in the office in follow-up and was reported to be "much improved". Outcome was reported as recovered. Documents held by sender: None.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia
Clinical narrative: Fever.
Age: 28.0
Sex: M
Vaccine: ADEN_4_7, FLU3, MNQ, TDAP
Symptoms: Blood creatine phosphokinase, Computerised tomogram, Guillain-Barre syndrome, Lumbar puncture, Muscular weakness
Clinical narrative: C/o rash, stiffness after receiving INH ON 2/13/2014, ll leg weakness.
Age: 28.0
Sex: M
Vaccine: ADEN_4_7, FLU3, MNQ, TDAP
Symptoms: Musculoskeletal stiffness, Rash, Thyroid function test
Clinical narrative: C/o rash, stiffness after receiving INH ON 2/13/2014, ll leg weakness.
Age: 12.0
Sex: M
Vaccine: VARCEL
Symptoms: Body temperature increased, Injection site induration, Injection site pruritus, Injection site swelling, Skin lesion
Clinical narrative: Patient's mother called to report injection site hard, swollen, and very itchy. He is running low grade temperature. Recommend heat to area, BENADRYL age appropriate, oatmeal baths, Calamine, watch for infections at lesion sites (8-9 places) on torso. No other symptoms noted. Offered appt mom declined at this time.
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of unknown demography. On 03-MAR-2014, the patient was vaccinated with expired dose of M-M-R II lot # 0232AE (Expiry: 26-JAN-2014) (dose, route and frequency were not reported). No adverse event reported. No other information to report. Additional information is not expected.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site inflammation, Injection site pain, Injection site warmth
Clinical narrative: Erythema of the left thigh measures 4 x 4 inches slight induration associated warmness, tenderness and inflammation of affected side.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Rash, Urticaria
Clinical narrative: Rash started at 8 pm, spreading all over trunk, sparingly axilla, flank. Urticaria.
Age: 13.0
Sex: M
Vaccine: HPV4
Symptoms: Headache
Clinical narrative: This spontaneous report as received from the consumer's parent via a company representative refers to a 13 year old male patient. The patient's current conditions or medical history were not reported. Approximately in February 2014, reported as last week, the patient was vaccinated with the second dose of GARDASIL (dose, route, lot and expiration date were not reported). On an unspecified date in February 2014, within 24 hours after receiving his second injection of GARDASIL the patient developed a severe headache. The patient's headache lasted 24-48 hours. At the time of the report the patient was recovered form severe headache. Additional information has been requested.