chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Fatigue, Incomplete course of vaccination, Malaise, Stool analysis, Ultrasound scan
Clinical narrative: Stomach and sternum pain fatigue vomiting lots of vomiting and has had vomiting everyday 3-4 sometime 10 times a day ever since for the past 2 years she has been to multiple hospitals and doctors and specialist she has been put on several different medications that do not calm it down she carries a bucket around at school she missed more days from school then she went all dr excused because that's how many times I have had to take her to the doctor and nothing is helping her she was a very healthy athletic girl that didn't miss school until a few days after she received the injection she has been fatigued and sick every single day since we did not finish the injections because I new that what made her sick I took her back to the same dr a few days later and told them that's what made her sick and they said it couldn't have and no one told me that I could report it and I no they didn't report it because they said I was wrong but Im not wrong I know what made my child sick Im very worried about my daughter and I want someone to give her something that reverses the injection right away because its ruining my daughters life I want someone to call me and tell me what Im supposed to do to help her now.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Urine analysis, Vomiting, X-ray
Clinical narrative: Stomach and sternum pain fatigue vomiting lots of vomiting and has had vomiting everyday 3-4 sometime 10 times a day ever since for the past 2 years she has been to multiple hospitals and doctors and specialist she has been put on several different medications that do not calm it down she carries a bucket around at school she missed more days from school then she went all dr excused because that's how many times I have had to take her to the doctor and nothing is helping her she was a very healthy athletic girl that didn't miss school until a few days after she received the injection she has been fatigued and sick every single day since we did not finish the injections because I new that what made her sick I took her back to the same dr a few days later and told them that's what made her sick and they said it couldn't have and no one told me that I could report it and I no they didn't report it because they said I was wrong but Im not wrong I know what made my child sick Im very worried about my daughter and I want someone to give her something that reverses the injection right away because its ruining my daughters life I want someone to call me and tell me what Im supposed to do to help her now.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PPV, RVX
Symptoms: Crying, Immediate post-injection reaction, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: Immediately after vaccination, extremely high-pitched screaming and crying for approximately 5 minutes. After going into the car (15 minutes after vaccination) child slept immediately. Upon returning home approximately 30 minutes after vaccination, child continued a screaming cry for approximately 5-6 hours. Approximately 2 hours after vaccination both legs were swollen, hot to the touch and muscles were rigid. When touched, child would flinch away and cry harder. The incidence with the legs and crying continued even with Tylenol and a cold compress being applied for approximately 10 hours until bed time around 9pm. At 2 years of age, child has been qualified for early intervention for speech therapy. Possible apraxia of speech.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PPV, RVX
Symptoms: Muscle rigidity, Screaming, Somnolence, Speech disorder, Tenderness
Clinical narrative: Immediately after vaccination, extremely high-pitched screaming and crying for approximately 5 minutes. After going into the car (15 minutes after vaccination) child slept immediately. Upon returning home approximately 30 minutes after vaccination, child continued a screaming cry for approximately 5-6 hours. Approximately 2 hours after vaccination both legs were swollen, hot to the touch and muscles were rigid. When touched, child would flinch away and cry harder. The incidence with the legs and crying continued even with Tylenol and a cold compress being applied for approximately 10 hours until bed time around 9pm. At 2 years of age, child has been qualified for early intervention for speech therapy. Possible apraxia of speech.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Drooling, Dysgeusia, Feeling abnormal, Hypoaesthesia oral, Hypotonia
Clinical narrative: Woke up in night with right side neck pain and nausea and felt bad. Over course of time the following symptoms occurred - front tooth numbness, drooling, strange tastes in mouth, watery eyes, blurred vision, unable to speak clearly, right sided facial flaccid.  Was diagnosed with Bells palsy.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Lacrimation increased, Nausea, Neck pain, Speech disorder, VIIth nerve paralysis
Clinical narrative: Woke up in night with right side neck pain and nausea and felt bad. Over course of time the following symptoms occurred - front tooth numbness, drooling, strange tastes in mouth, watery eyes, blurred vision, unable to speak clearly, right sided facial flaccid.  Was diagnosed with Bells palsy.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Vision blurred
Clinical narrative: Woke up in night with right side neck pain and nausea and felt bad. Over course of time the following symptoms occurred - front tooth numbness, drooling, strange tastes in mouth, watery eyes, blurred vision, unable to speak clearly, right sided facial flaccid.  Was diagnosed with Bells palsy.
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness, swelling with site fever.
Age: 15.0
Sex: F
Vaccine: YF
Symptoms: Headache, Myalgia, Pyrexia, Rash generalised, Rash pruritic
Clinical narrative: Received yellow fever vaccine on 4/25/14. Received hepatitis A vaccine on 4/21/14 through primary care. On 4/26/14, pt. developed itchy rash on back, trunk, neck, back of knees, and inner elbows, inner thighs, fever of 100 degrees, headache and muscle aches. Her rash went away that evening after taking Benadryl. On 4/27/14, she woke up with yellow discoloration underneath her eyes. No yellow of eye sclera noted. These symptoms were reported by mother. Pt continued her regular activities while symptomatic and symptoms are now totally resolved.
Age: 15.0
Sex: F
Vaccine: YF
Symptoms: Yellow skin
Clinical narrative: Received yellow fever vaccine on 4/25/14. Received hepatitis A vaccine on 4/21/14 through primary care. On 4/26/14, pt. developed itchy rash on back, trunk, neck, back of knees, and inner elbows, inner thighs, fever of 100 degrees, headache and muscle aches. Her rash went away that evening after taking Benadryl. On 4/27/14, she woke up with yellow discoloration underneath her eyes. No yellow of eye sclera noted. These symptoms were reported by mother. Pt continued her regular activities while symptomatic and symptoms are now totally resolved.
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Rash erythematous, Urticaria
Clinical narrative: Noticed a small red bump on her back along her spine. The next morning (6AM) she had hives all over her stomach, back and on the upper thigh of one leg.
Age: 6.0
Sex: M
Vaccine: HEP
Symptoms: Arthralgia, Cough, Diarrhoea, Faeces pale, Fatigue
Clinical narrative: Low grade fever, runny nose, cough that turned into a serious cough needing to be treated with medication, diarrhea, yellow stools, yellow skin, lethargic, achy joints and overall tired lasting more than 2 weeks and he's still sick.
Age: 6.0
Sex: M
Vaccine: HEP
Symptoms: Lethargy, Malaise, Pyrexia, Rhinorrhoea, Yellow skin
Clinical narrative: Low grade fever, runny nose, cough that turned into a serious cough needing to be treated with medication, diarrhea, yellow stools, yellow skin, lethargic, achy joints and overall tired lasting more than 2 weeks and he's still sick.
Age: 57.0
Sex: F
Vaccine: FLU(H1N1), FLUX
Symptoms: Cardiac stress test, Catheterisation cardiac, Cough, Echocardiogram, Influenza like illness
Clinical narrative: Flu like symptoms, developed a persistent cough that lasted a long time.
Age: 57.0
Sex: F
Vaccine: FLU(H1N1), FLUX
Symptoms: Laboratory test, X-ray
Clinical narrative: Flu like symptoms, developed a persistent cough that lasted a long time.
Age: 4.0
Sex: U
Vaccine: DTAPIPV
Symptoms: Ataxia, Muscular weakness, Viral infection
Clinical narrative: This case was reported in a literature article and described the occurrence of ataxia in a 4-year-old subject of unspecified gender who was vaccinated with DTaP-IPV (manufacturer unspecified). Concurrent medical conditions included fever and otitis media 2 days prior vaccination. The subject may have received other vaccines the same day. On an unspecified date, the subject received unspecified dose of DTaP-IPV (unknown route, injection site and batch number). Four days after vaccination with DTaP-IPV, the subject experienced upper and lower extremity weakness. The subject was hospitalised. The next day the weakness was substantially improved, the child was discharged with the diagnosis of post-viral ataxia. Guillain Barre syndrome was ruled out. Article summary: In 2008, a DTaP-IPV was licensed for use in children 4 through 6 years of age. While pre-licensure studies did not demonstrate significant safety concerns, the number vaccinated in these studies was not sufficient to examine the risk of uncommon but serious adverse events. The objective was to assess the risk of serious adverse events following DTaP-IPV vaccination. The study was conducted from January 2009 to September 2012 in the project. In the project, electronic vaccination and encounter data were updated and aggregated weekly as part of ongoing surveillance activities. Based on previous reports and biologic plausibility, eight potential adverse events were monitored: meningitis/encephalitis; seizures; stroke; Guillain-Barre syndrome; Stevens-Johnson syndrome; anaphylaxis; serious allergic reactions other than anaphylaxis and serious local reactions. Adverse event rates in DTaP-IPV recipients were compared to historical incidence rates in the project population prior to 2009. Sequential probability ratio testing was used to analyze the data on a weekly basis. During the study period, 201,116 children received DTaP-IPV vaccine. ninety-seven percent of DTaP-IPV recipients also received other vaccines on the same day, typically MMR and varicella vaccines. There was no statistically significant increased risk of any of the eight pre-specified adverse events among DTaP-IPV recipients when compared to historical incidence rates. In conclusions, this safety surveillance study of more than 200,000 DTaP-IPV vaccine recipients, there was no evidence of increased risk for any of the pre-specified adverse events monitored. Continued surveillance of DTaP-IPV vaccine safety may be warranted to monitor for rare adverse events, such as Guillain-Barre syndrome. This case was part of the diagnosis code for Guillain-Barre syndrome. This case is one of the 2 cases described in the literature article.
Sex: U
Vaccine: DTAP, HIBV, MMR, VARCEL
Symptoms: Febrile convulsion, Otitis media, Pyrexia
Clinical narrative: This case was reported in a literature article and described the occurrence of febrile seizure in a subject of unspecified gender born between 1974 and 2008 who was vaccinated with Hib vaccine (manufacturer unspecified), Dtap vaccine, MMR vaccine (non-gsk) and varicella virus vaccine (non-gsk). Concurrent medical conditions included DiGeorge's syndrome and had a chromosome 22q11.2 microdeletion detected by fluorescence in situ hybridization assay. No further information on the subject's medical, family history or concurrent medication is available. On an unspecified date, the subject received an unspecified dose of Hib vaccine (administration site and route unknown, batch number not provided), an unspecified dose of Dtap vaccine (administration site and route unknown, batch number not provided), an unspecified dose of MMR vaccine (Non-GSK) (unknown) and an unspecified dose of Varicella virus vaccine (Non-GSK) (unknown). 5 days after vaccination with Dtap vaccine, Hib vaccine, MMR vaccine (Non-GSK) and Varicella virus vaccine (Non-GSK), the subject experienced febrile seizure. 5 days later, the subject had otitis media and fever. This case was assessed as medically serious by GSK. At the time of reporting, the outcome of the events was unspecified. The author's conclusion stated that their data expanded the findings of smaller studies indicating that live vaccination of patients with DGS with mild-to-moderate immunosuppression was well-tolerated. Prospective studies are needed to confirm their findings and offer guidance for live vaccination. Because this study included few patients with DGS with severe immunosuppression, further retrospective investigation of this population is warranted. This case is one of the 18 cases reported in the same literature article.
Sex: U
Vaccine: DTAP, IPV, MMR
Symptoms: Pneumonia
Clinical narrative: This case was reported in a literature article and described the occurrence of pneumonia in a subject of unspecified age and gender born between 1974 and 2008 who was vaccinated with DTPa (small content), (manufacturer unspecified), MMR vaccine (non-gsk) and IPV (non-gsk). Concurrent medical conditions included DiGeorge's syndrome and had a chromosome 22q11.2 microdeletion detected by fluorescence in situ hybridization assay. No further information on the subject's medical, family history or concurrent medication is available. On an unspecified date, the subject received an unspecified dose of DTPa (small content) (administration site and route unknown, batch number not provided), an unspecified dose of MMR vaccine (Non-GSK) (unknown) and an unspecified dose of IPV (Non-GSK) (unknown). 15 days after vaccination with DTPa (small content), MMR vaccine (Non-GSK) and IPV (Non-GSK), the subject experienced pneumonia. This case was assessed as medically serious by GSK. At the time of reporting, the outcome of the event was unspecified. According to the Modified WHO Causality Criteria, pneumonia was unlikely related to vaccination with MMR vaccine. The author's conclusion stated that their data expanded the findings of smaller studies indicating that live vaccination of patients with DGS with mild-to-moderate immunosuppression was well-tolerated. Prospective studies are needed to confirm their findings and offer guidance for live vaccination. Because this study included few patients with DGS with severe immunosuppression, further retrospective investigation of this population is warranted. This case is one of the 18 cases reported in the same literature article.
Age: 37.0
Sex: F
Vaccine: FLUX
Symptoms: Rash generalised, Swelling
Clinical narrative: This case was reported by a healthcare professional (pharmacy technician) and described the occurrence of swollen all over in a 37-year-old female subject who was vaccinated with influenza vaccine unspecified (manufacturer unspecified). Concurrent medical conditions included penicillin allergy. In 2008, "about 5 years ago" the subject received a dose of influenza vaccine unspecified (unknown details). In 2008, 30 minutes after vaccination with influenza vaccine unspecified, the subject experienced swollen all over and rash all over. The subject was taken to the emergency room and subsequently discharged. The subject was not hospitalized. The healthcare professional considered the events were disabling. At the time of reporting the outcome of the events were unspecified. The reporter had limited information to provide at the time of reporting. Follow-up information was received on 29 April 2014 via pharmacy tech who reported the subject experienced the events in 2008 and resolved in 2008; dates not specified. The reporting pharmacy tech did not consider the events serious. Details regarding the flu vaccination were unknown as it was not administered at the reporting technician's pharmacy. No action was taken with the flu vaccine; it was unknown if it was reintroduced or if symptoms recurred. No other information was provided.
Sex: U
Vaccine: FLUX, MMR, VARCEL
Symptoms: Pneumonia, Rash
Clinical narrative: This case was reported in a literature article and described the occurrence of pneumonia in a subject of unspecified age and gender born between 1974 and 2008 who was vaccinated with Influenza vaccine (manufacturer unspecified), varicella virus vaccine (non-gsk) and MMR vaccine (non-gsk). Concurrent medical conditions included DiGeorge's syndrome and had a chromosome 22q11.2 microdeletion detected by fluorescence in situ hybridization assay. No further information on the subject's medical, family history or concurrent medication is available. On an unspecified date, the subject received an unspecified dose of Influenza vaccine (administration site and route unknown, batch number not provided), an unspecified dose of Varicella virus vaccine (Non-GSK) (unknown) and an unspecified dose of MMR vaccine (Non-GSK) (unknown). 54 days after vaccination with Influenza vaccine and Varicella virus vaccine (Non-GSK), the subject experienced pneumonia. The authors mentioned that the same subject developed a rash 9 days after being vaccinated against MMR but they did not specify if this occurred on or after this event. This case was assessed as medically serious by GSK. At the time of reporting, the outcome of the events was unspecified. According to the Modified WHO Causality Criteria, pneumonia was unlikely related to vaccination with varicella vaccine, the rash was probably related to vaccination with MMR vaccine. The author's conclusion stated that their data expanded the findings of smaller studies indicating that live vaccination of patients with DGS with mild-to-moderate immunosuppression was well-tolerated. Prospective studies are needed to confirm their findings and offer guidance for live vaccination. Because this study included few patients with DGS with severe immunosuppression, further retrospective investigation of this population is warranted. This case is one of the 18 cases reported in the same literature article.
Sex: U
Vaccine: FLUX, MMR, VARCEL
Symptoms: Pneumonia, Pyrexia, Upper respiratory tract infection
Clinical narrative: This case was reported in a literature article and described the occurrence of pneumonia in a subject of unspecified age and gender born between 1974 and 2008 who was vaccinated with Influenza vaccine (manufacturer unspecified), MMR vaccine (non-gsk) and varicella virus vaccine (non-gsk). Concurrent medical conditions included DiGeorge's syndrome and had a chromosome 22q11.2 microdeletion detected by fluorescence in situ hybridization assay. No further information on the subject's medical, family history or concurrent medication is available. On an unspecified date, the subject received an unspecified dose of Influenza vaccine (administration site and route unknown, batch number not provided), an unspecified dose of MMR vaccine (Non-GSK) (unknown) and an unspecified dose of Varicella virus vaccine (Non-GSK) (unknown). 20 days after vaccination with Influenza vaccine, MMR vaccine (Non-GSK) and Varicella virus vaccine (Non-GSK), the subject experienced pneumonia. 56 days after vaccination with Influenza vaccine, MMR vaccine (Non-GSK) and Varicella virus vaccine (Non-GSK), the subject experienced upper respiratory infection and fever. This case was assessed as medically serious by GSK. At the time of reporting, the outcome of the events was unspecified. According to the Modified WHO Causality Criteria, pneumonia was unlikely related to vaccination with MMR and varicella vaccine. The author's conclusion stated that their data expanded the findings of smaller studies indicating that live vaccination of patients with DGS with mild-to-moderate immunosuppression was well-tolerated. Prospective studies are needed to confirm their findings and offer guidance for live vaccination. Because this study included few patients with DGS with severe immunosuppression, further retrospective investigation of this population is warranted. This case is one of the 18 cases reported in the same literature article.
Sex: U
Vaccine: DTAP, IPV, MMR
Symptoms: Croup infectious, Lymphadenopathy, Pyrexia
Clinical narrative: This case was reported in a literature article and described the occurrence of croup in a subject of unspecified age and gender born between 1974 and 2008 who was vaccinated with DTaP (manufacturer unspecified), MMR vaccine (non-gsk) and IPV (non-gsk). This case refers to a subject. Concurrent medical conditions included DiGeorge's syndrome and had a chromosome 22q11.2 microdeletion detected by fluorescence in situ hybridization assay. No further information on the subject's medical, family history or concurrent medication is available. On an unspecified date, the subject received an unspecified dose of DTaP (small content) (administration site and route unknown, batch number not provided), an unspecified dose of MMR vaccine (Non-GSK) (unknown) and an unspecified dose of IPV (Non-GSK) (unknown). 39 days after vaccination with DTaP (small content), MMR vaccine (Non-GSK) and IPV (Non-GSK), the subject experienced croup, fever and lymphadenopathy. This case was assessed as medically serious by GSK. At the time of reporting, the outcome of the events was unspecified. The author's conclusion stated that their data expanded the findings of smaller studies indicating that live vaccination of patients with DGS with mild-to-moderate immuno-suppression was well-tolerated. Prospective studies are needed to confirm their findings and offer guidance for live vaccination. Because this study included few patients with DGS with severe immunosuppression, further retrospective investigation of this population is warranted. This case is one of the 18 cases reported in the same literature article.
Sex: U
Vaccine: DTAP, HEP, HIBV, IPV, RV5, DTAPH, HEP, IPV, RV5, DTAP, HEP, HIBV, IPV, RV5
Symptoms: Bronchospasm, Respiratory syncytial virus bronchiolitis
Clinical narrative: This case was reported in a literature article and described the occurrence of respiratory syncytial virus bronchiolitis in a subject of unspecified age and gender born between 1974 and 2008 who was vaccinated with Hib vaccine (manufacturer unspecified), Hepatitis B vaccine, Rotavirus vaccine, DTPa (small content) and IPV (non-gsk). Concurrent medical conditions included DiGeorge's syndrome and had a chromosome 22q11.2 microdeletion detected by fluorescence in situ hybridization assay. No further information on the subject's medical, family history or concurrent medication is available. On an unspecified date, the subject received an unspecified dose of Hib vaccine (administration site and route unknown, batch number not provided), an unspecified dose of Hepatitis B vaccine (administration site and route unknown, batch number not provided), an unspecified dose of Rotavirus vaccine (oral, batch number not provided), an unspecified dose of DTPa (small content) (administration site and route unknown, batch number not provided) and an unspecified dose of IPV (Non-GSK) (unknown). Less than one day after vaccination with DTPa (small content), Hepatitis B vaccine, Hib vaccine, IPV (Non-GSK) and Rotavirus vaccine, the subject experienced respiratory syncytial virus bronchiolitis and bronchospasm. The subject was hospitalised. No information has been provided regarding any examination or investigation performed on the subject. At the time of reporting the outcome of the events were unspecified. The author's conclusion stated that their data expanded the findings of smaller studies indicating that live vaccination of patients with DGS with mild-to-moderate immunosuppression was well-tolerated. Prospective studies are needed to confirm their findings and offer guidance for live vaccination. Because this study included few patients with DGS with severe immunosuppression, further retrospective investigation of this population is warranted. This case is one of the 18 cases reported in the same literature article.
Age: 77.0
Sex: M
Vaccine: FLUX
Symptoms: Candida infection, Dry mouth, Headache, Lethargy, Stomatitis
Clinical narrative: This case was reported by a pharmacist and described the occurrence of thrush in a 77-year-old male subject who was vaccinated with Influenza vaccine unspecified (manufacturer unspecified). In 2010, the subject received an unspecified dose of Influenza vaccine unspecified (unknown route and injection site, batch number not provided). Within 12 hours after vaccination with Influenza vaccine unspecified, the subject experienced dry mouth, thrush, mouth sores, headache and lethargy. The events occurred intermittently for several months. The pharmacist considered the events were disabling. At the time of reporting, the events were mostly resolved. The dry mouth was improved but the subject still experienced it on occasion (not as severe as it was in the beginning). The pharmacist considered the events were probably related to vaccination with Influenza vaccine unspecified.
Sex: U
Vaccine: HIBV, MMR, VARCEL
Symptoms: Febrile convulsion, Thrombocytopenia, Viral infection
Clinical narrative: This case was reported in a literature article and described the occurrence of febrile seizure in a subject of unspecified gender born between 1974 and 2008 who was vaccinated with Hib (manufacturer unspecified), MMR (non-gsk) and varicella virus vaccine (non-gsk). This case refers to a subject. Concurrent medical conditions included DiGeorge's syndrome and had a chromosome 22q11.2 microdeletion detected by fluorescence in situ hybridization assay. No further information on the subject's medical, family history or concurrent medication is available. On an unspecified date, the subject received an unspecified dose of Hib vaccine (administration site and route unknown), an unspecified dose of MMR vaccine (Non-GSK) (unknown) and an unspecified dose of varicella virus vaccine (Non-GSK) (unknown). 5 days after vaccination with Hib, MMR (Non-GSK) and varicella virus (Non-GSK), the subject experienced febrile seizure, thrombocytopenia and viral illness. This case was assessed as medically serious by GSK. At the time of reporting, the outcome of the events was unspecified. The author's conclusion stated that their data expanded the findings of smaller studies indicating that live vaccination of patients with DGS with mild-to-moderate immuno-suppression was well-tolerated. Prospective studies are needed to confirm their findings and offer guidance for live vaccination. Because this study included few patients with DGS with severe immunosuppression, further retrospective investigation of this population is warranted. This case is one of the 18 cases reported in the same literature article.
Age: 25.0
Sex: F
Vaccine: TYP
Symptoms: Abdominal pain lower, Abdominal pain upper, Constipation, Headache
Clinical narrative: Patient began use of oral typhoid on 4/21/2014 in preparation for upcoming trip. She took her second dose on 4/23 and will take 3rd dose tonight (4/25) and final dose on 4/27. Approximately 24 hours after 1st dose (4/21) she began to experience a mild headache with stomach cramping. After her second dose, her headache worsened and she took her MAXALT w/o relief of 6/10 headache. Her stomach ache continued and she has urge to have a BM but cannot. She reported to medical this morning (4/25) due to persistent headache (throbbing ache around head) and no BM in 3 days and some sharp diffuse mid/lower abdominal pains. Headache is similar to past migraine but MAXALT typically resolves -this one is not. She believes this is just the side effects from the vaccine she was advised about. She advised she was told to come to VHC by sick-call provider for further evaluation.
Age: 74.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: Left arm pain and shoulder pain ongoing after shot.
Age: 31.0
Sex: M
Vaccine: HEPAB
Symptoms: Urticaria, Vaccine positive rechallenge
Clinical narrative: 3/27/14 #1 TWINRIX given. 3-4 days later broke out in hives - did not relate it to vaccine - no difficulty breathing or swelling - no treatment. 4/29/14 #2 TWINRIX given. 10-11 hrs later broke out in hives, - did not have difficulty breathing or swelling - no treatment.
Age: 0.38
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Erythema, Skin discolouration, Urticaria
Clinical narrative: Pt. broke out in hives about 20 min. after getting vaccines. Hives began on trunk and spread to limbs then covered pt. head to toe. At first appearing dark red-purple hives fade to light red after about 10 min. Lung sounds are clear all bases. Pt. not short of breath. Pt. is laughing and playful.
Age: 59.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Dysphagia, Hypoaesthesia, Local swelling, Pain in extremity, Pharyngeal oedema
Clinical narrative: Patient reported pain, numbness, and swelling in left arm. Also reported swelling of throat which caused difficulty swallowing. Treated with prednisone.
Age: 51.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Pruritus generalised
Clinical narrative: Itching all over - no rash.
Age: 0.34
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Vomiting for 36 hours after. Stools have been more loose.
Age: 26.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Chills, Decreased appetite, Fatigue, Local swelling, Pyrexia
Clinical narrative: Right arm was severely swollen. Also had chills and a rash on my groin. It lasted for 3 days. Fever, fatigued and anorexia. Happened with both doses, > with 2nd.
Age: 26.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Rash, Vaccine positive rechallenge
Clinical narrative: Right arm was severely swollen. Also had chills and a rash on my groin. It lasted for 3 days. Fever, fatigued and anorexia. Happened with both doses, > with 2nd.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Dysstasia, Loss of consciousness, Nausea, Visual impairment
Clinical narrative: Patient received four vaccines, left exam room to walk to lab and patient passed out, hit door frame and exam table corner before landing on ground. After 1 hr. 15 min observation and patient still unable to sit-up or stand, still complained of seeing spots and nausea was transported to ER by ambulance.
Age: 16.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Eyelid ptosis, Headache, Lacrimation increased, Pain in extremity, Pain in jaw
Clinical narrative: Tdap administered 4/28/14 for middle school entry. Awoke 4/29/14 am with bilateral leg pain, right side of face swollen, bilateral jaw pain with difficulty opening mouth. No fever. Also, had headache. Right side of face swollen with drooping mouth and right eyelid lag with excessive tearing. Sent to ED.
Age: 16.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Swelling face, Trismus, VIIth nerve paralysis
Clinical narrative: Tdap administered 4/28/14 for middle school entry. Awoke 4/29/14 am with bilateral leg pain, right side of face swollen, bilateral jaw pain with difficulty opening mouth. No fever. Also, had headache. Right side of face swollen with drooping mouth and right eyelid lag with excessive tearing. Sent to ED.
Age: 16.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Abasia, Activities of daily living impaired, Areflexia, Asthenia, Back pain
Clinical narrative: Tdap administered 4/28/14 for middle school entry. Awoke 4/29/14 am with bilateral leg pain, right side of face swollen, bilateral jaw pain with difficulty opening mouth. No fever. Also, had headache. Right side of face swollen with drooping mouth and right eyelid lag with excessive tearing. Sent to ED.
Age: 16.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: C-reactive protein abnormal, CSF test abnormal, Demyelination, Dysstasia, Electromyogram abnormal
Clinical narrative: Tdap administered 4/28/14 for middle school entry. Awoke 4/29/14 am with bilateral leg pain, right side of face swollen, bilateral jaw pain with difficulty opening mouth. No fever. Also, had headache. Right side of face swollen with drooping mouth and right eyelid lag with excessive tearing. Sent to ED.
Age: 16.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Gait disturbance, Guillain-Barre syndrome, Hyporeflexia, Immunoglobulin therapy, Incorrect dose administered
Clinical narrative: Tdap administered 4/28/14 for middle school entry. Awoke 4/29/14 am with bilateral leg pain, right side of face swollen, bilateral jaw pain with difficulty opening mouth. No fever. Also, had headache. Right side of face swollen with drooping mouth and right eyelid lag with excessive tearing. Sent to ED.
Age: 16.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Intensive care, Mobility decreased, Muscular weakness, Musculoskeletal pain, Nerve conduction studies abnormal
Clinical narrative: Tdap administered 4/28/14 for middle school entry. Awoke 4/29/14 am with bilateral leg pain, right side of face swollen, bilateral jaw pain with difficulty opening mouth. No fever. Also, had headache. Right side of face swollen with drooping mouth and right eyelid lag with excessive tearing. Sent to ED.
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: Tdap administered 4/28/14 for middle school entry. Awoke 4/29/14 am with bilateral leg pain, right side of face swollen, bilateral jaw pain with difficulty opening mouth. No fever. Also, had headache. Right side of face swollen with drooping mouth and right eyelid lag with excessive tearing. Sent to ED.
Age: 54.0
Sex: U
Vaccine: MNQ
Symptoms: Abdominal pain, Arthralgia, Cheilitis, Chills, Decreased appetite
Clinical narrative: Pt started symptoms late night of 9th easy later fever, chills, shaky, swelling of the lips and the site of injection/vaccine, blisters in the mouth, diarrhea, abd. pain, headache, fatigue, arthralgia, anorexia, rash nose, lips, drowsiness. ZYRTEC and VALTREX given.
Age: 54.0
Sex: U
Vaccine: MNQ
Symptoms: Diarrhoea, Fatigue, Headache, Injection site swelling, Lip swelling
Clinical narrative: Pt started symptoms late night of 9th easy later fever, chills, shaky, swelling of the lips and the site of injection/vaccine, blisters in the mouth, diarrhea, abd. pain, headache, fatigue, arthralgia, anorexia, rash nose, lips, drowsiness. ZYRTEC and VALTREX given.
Age: 54.0
Sex: U
Vaccine: MNQ
Symptoms: Oral mucosal blistering, Pyrexia, Rash, Somnolence, Tremor
Clinical narrative: Pt started symptoms late night of 9th easy later fever, chills, shaky, swelling of the lips and the site of injection/vaccine, blisters in the mouth, diarrhea, abd. pain, headache, fatigue, arthralgia, anorexia, rash nose, lips, drowsiness. ZYRTEC and VALTREX given.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Paraesthesia, Rash
Clinical narrative: Pt began feeling "tingling" on her back within 24 hrs. Got much worse and definite rash appeared in a square on lower back. Very painful by 4/29/14. On 4/30 went to MD and diagnosed shingles. Began VALTREX 1g three times daily x 1 week. Pt using ice/heat for pain. Rash appeared 4/28.
Sex: F
Vaccine: VARCEL
Symptoms: Hypersensitivity, Reaction to preservatives
Clinical narrative: This spontaneous report as received from a registered nurse refers to a currently 17 years old female patient. On an unknown date the patient was vaccinated with VARIVAX (Merck) (route, lot number, expiration date not reported). No other relevant medical history and no concomitant medications were reported. The reporter stated that on an unknown date the patient experienced an unspecified allergic reaction when she was younger to the preservative that was in VARIVAX (Merck). The outcome of the allergic reaction was reported as recovered/resolved. No further relevant information was provided. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Burning sensation, Pain
Clinical narrative: This spontaneous report was received from a healthcare worker via a company representative refer to unspecified number of patients (age, gender unknown). The healthcare worker reported that unspecified number of patients had reported burning and pain after receiving a dose of GARDASIL (dates unspecified). This is one of several reports received from the same reporter (case# 1404USA010532 and case# 1404USA012598). Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: This spontaneous report as received from a nurse refers to a 8 year old female patient with latex allergy, OMNICEF allergy and no pertinent medical history. On 23-MAR-2011 and 23-MAR-2011 the patient was vaccinated with VARIVAX (Merck) dose 1 and dose 2 (lot no, dose, route not reported) respectively. There was no concomitant medication. On 15-APR-2014, the patient had a rash. The patient sought medical attention via calling to office. No treatment was given for the event. No lab diagnostics studies were performed. The outcome of rash was reported as not recovered. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX (lot# was not reported). A couple of years ago on an unknown date the patient experienced shingles. The outcome of shingles was unknown. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age. On an unknown date the patient was vaccinated with PEDVAXHIB (lot# was not reported). Nurse reported that the patient received PEDVAXHIB, improperly stored in a plastic syringe, exposed to 36F to 45F for a maximum of 24 hours. No adverse effect reported. Additional information has been requested.
Age: 0.2
Sex: F
Vaccine: RV5
Symptoms: Oral administration complication, Vomiting
Clinical narrative: This spontaneous report as received from a nurse refers to a 2 month old female patient. Pertinent medical history, concomitant medication, drug reactions and allergies were not provided. On 24-APR-2014, the patient inadvertently received a partial dose of ROTATEQ oral (dose, frequency, lot number and expiration date were not reported) due to vomiting during administration of the dose. The outcome of events was unknown. The relatedness between vomiting and ROTATEQ was not reported. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to an unspecified number of patients of unknown ages and genders. On an unknown date, the patients were vaccinated with M-M-R II (dose, route and lot number were not reported), vaccine had been exposed to multiple excursions with highest temperature reaching 57F for total time of 206 hours and these vaccines' stability could not be supported. No adverse effects reported. This is one of several reports from the same source. Follow up information was received with patient identifiers. This case reported that M-M-R II (dose and route not reported, lot# J004201, therapy type unknown, expired date 12-APR-2015) was administered to a 4 year old patient. This is case 2 of 3 patients which were exposed to M-M-R II. This case was linked to cases: 1403USA006581 and 1404USA015675. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to an unspecified number of patients of unknown ages and genders. On an unknown date, the patients were vaccinated with M-M-R II (dose, route and lot number were not reported), vaccine had been exposed to multiple excursions with highest temperature reaching 57F for total time of 206 hours and these vaccines stability could not be supported. No adverse effects reported. This is one of several reports from the same source. Follow up information was received with patient identifiers. This case reported that M-M-R II (dose and route not reported, lot# J006953, therapy type unknown, expired date 07-JUN-2015, also reported as 07-JUL-2015) was administered to a 20 year old patient on 03-MAR-2014. This is case 3 of 3 patients which were exposed to M-M-R II. This case was linked to cases: 1403USA006581 and 1404USA015674. Additional information has been requested.
Age: 1.5
Sex: F
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a medical assistant (Immunization coordinator) refers to a child patient of unknown age. It was reported that the child was supposed to receive VARIVAX (Merck), however, PROQUAD (Merck) (0.5 ml, subcutaneous, lot# unspecified) was administered inadvertently, instead of M-M-R II on 23-APR-2014, and the child received PROQUAD (Merck) and VARIVAX (Merck) (J008652, exp date as 10-JUL-2015, 0.5 ml, subcutaneous) on a same day (23-APR-2014) inadvertently. No adverse effects reported. Additional information has been requested.
Age: 2.0
Sex: F
Vaccine: PPV
Symptoms: Anaphylactoid reaction, Blood immunoglobulin A normal, Blood immunoglobulin G decreased, Immune tolerance induction, Immunoglobulin therapy
Clinical narrative: Information has been received from a published literature article. In the literature article it was reported that modern advances in medicine involving the application of intravenous immunoglobulin G (IVIG) had restored host immune defense mechanisms and improved quality of life in patients with primary immunodeficiency. Hypersensitivity reactions could occur with intravenous immunoglobulin G (IVIG). A 2 year old female with a complex medical history including premature birth at 27 weeks, hypogammaglobulinemia and recurrent infections underwent a desensitization protocol for intravenous immunoglobulin G (IVIG). Palivizumab and PCV (manufacturer unknown) resulted in anaphylactoid reaction. The patient was referred to allergy and immunology. Immunoglobulins were significant for a decreased IgG level of 364 mg/dL and an IgA level of 19 mg/dL. Intravenous immunoglobulin G (IVIG) replacement therapy was initiated. Patient developed respiratory distress during her first infusion. An hour after this infusion, hives occurred. Despite clinical improvement, she continued to experience instability in her vital signs during infusions. Therapy was stopped due to intolerance. Desensitization was attempted to ultimately reduce morbidity from recurrent infections. She was initiated on dilutions of intravenous immunoglobulin G (IVIG) in an intensive care setting. Desensitization was tolerated with close monitoring. The outcome of the event was unknown. The reporter considered that the event was related to PCV (manufacturer unknown). Additional information has been requested.
Age: 2.0
Sex: F
Vaccine: PPV
Symptoms: Intensive care, Respiratory distress, Urticaria
Clinical narrative: Information has been received from a published literature article. In the literature article it was reported that modern advances in medicine involving the application of intravenous immunoglobulin G (IVIG) had restored host immune defense mechanisms and improved quality of life in patients with primary immunodeficiency. Hypersensitivity reactions could occur with intravenous immunoglobulin G (IVIG). A 2 year old female with a complex medical history including premature birth at 27 weeks, hypogammaglobulinemia and recurrent infections underwent a desensitization protocol for intravenous immunoglobulin G (IVIG). Palivizumab and PCV (manufacturer unknown) resulted in anaphylactoid reaction. The patient was referred to allergy and immunology. Immunoglobulins were significant for a decreased IgG level of 364 mg/dL and an IgA level of 19 mg/dL. Intravenous immunoglobulin G (IVIG) replacement therapy was initiated. Patient developed respiratory distress during her first infusion. An hour after this infusion, hives occurred. Despite clinical improvement, she continued to experience instability in her vital signs during infusions. Therapy was stopped due to intolerance. Desensitization was attempted to ultimately reduce morbidity from recurrent infections. She was initiated on dilutions of intravenous immunoglobulin G (IVIG) in an intensive care setting. Desensitization was tolerated with close monitoring. The outcome of the event was unknown. The reporter considered that the event was related to PCV (manufacturer unknown). Additional information has been requested.
Age: 74.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: C-reactive protein increased, Groin pain, Pain in extremity, Red blood cell sedimentation rate increased
Clinical narrative: This spontaneous report as received from a 74 year old male patient with hypothyroidism and no known drug reactions. On 10-FEB-2014 the patient was vaccinated with a dose of ZOSTAVAX (lot#, dose and route not reported). Concomitant therapies included levothyroxine. The consumer reported that after getting ZOSTAVAX shot, on 10-MAR-2014, he experienced pain in his groin area and muscle tightness which spread to his thighs. The patient was diagnosed by his doctor with Polymyalgia rheumatica (PMR). The patient visited the physician to seek medical attention. Treatment included prednisone, CELEBREX and naproxen sodium. Lab tests included 5-6 unspecified blood tests, results unspecified. The patient also stated that after receiving treatment with prednisone he was recovering and "getting better every day". Additional information has been requested.
Age: 74.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Groin pain, Muscle tightness, Polymyalgia rheumatica
Clinical narrative: This spontaneous report as received from a 74 year old male patient with hypothyroidism and no known drug reactions. On 10-FEB-2014 the patient was vaccinated with a dose of ZOSTAVAX (lot#, dose and route not reported). Concomitant therapies included levothyroxine. The consumer reported that after getting ZOSTAVAX shot, on 10-MAR-2014, he experienced pain in his groin area and muscle tightness which spread to his thighs. The patient was diagnosed by his doctor with Polymyalgia rheumatica (PMR). The patient visited the physician to seek medical attention. Treatment included prednisone, CELEBREX and naproxen sodium. Lab tests included 5-6 unspecified blood tests, results unspecified. The patient also stated that after receiving treatment with prednisone he was recovering and "getting better every day". Additional information has been requested.
Age: 51.0
Sex: F
Vaccine: PPV
Symptoms: Hypersensitivity, Injected limb mobility decreased, Injection site discolouration, Injection site reaction, Injection site swelling
Clinical narrative: Swelling and red rash and near the site on the injection arm turn purple. by 3pm I could not move my arm. Tried ice and heat and could not sleep or move my shoulder due to swelling and neck swelling. 4/25/2014 schedule apt with provider to report and evaluate my arm.
Age: 51.0
Sex: F
Vaccine: PPV
Symptoms: Insomnia, Local swelling, Rash erythematous
Clinical narrative: Swelling and red rash and near the site on the injection arm turn purple. by 3pm I could not move my arm. Tried ice and heat and could not sleep or move my shoulder due to swelling and neck swelling. 4/25/2014 schedule apt with provider to report and evaluate my arm.
Age: 40.0
Sex: F
Vaccine: TD
Symptoms: Urticaria
Clinical narrative: Woke up with urticaria on legs 5/1/2014.