chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL, MNQ, TDAP, VARCEL
Symptoms: Pain in extremity, Swelling
Clinical narrative: Case number PHHY2013US069319 is an initial spontaneous report received from a consumer (patient's mother) via the Vaccine Adverse Event Reporting System (VAERS reference number: 486209) website on 03 Jul 2013, with a follow up received from the QA department on 13 Aug 2013. This report refers to a 11-year-old male patient. His medical history included viral infection and he had overcome it. He was not taking any medications at the time of vaccination. He was vaccinated with MENVEO (batch number: A11076/M11076) into left arm, ADACEL (other manufacturer, batch number: C4170AA) into right arm and VARIVAX (other manufacturer, batch number: H015559) into right arm on 07 Nov 2012. ON 11 Nov 2013, four days after vaccination, he started to experience pain and swelling in hands and feet. It was reported that swelling started with finger and spread all over body. His mother stated that her son was currently unable to attend the school and barely could walk. He also had elevated liver enzymes (values not reported) on an unspecified date. He visited the emergency room and consulted pediatric rheumatologist who had done a number of blood tests (results not provided). The outcome of the events was reported as not recovered as of 05 Mar 2013. The reporter assessed the case as serious (permanent disability). No causality was provided for the events. Based on the batch review, it was stated that the concerned MENVEO batch number A11076/M11076 was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Follow up received from the QA department on 13 Aug 2013: Updated batch report.
Age: 1.26
Sex: F
Vaccine: VARCEL
Symptoms: Rash erythematous, Rash macular, Urticaria
Clinical narrative: First noticed small red spots under arms and lower abdomen which progressed to larger blotchy red spots (hives) all over body by monday 8/12/13, treated with Benadryl with not much if any change. Hives started fading on 8/16/13 to smaller red spots. To date still has a few red spots on lower abd, buttocks, and legs.
Sex: U
Vaccine: HEP
Symptoms: Seroconversion test negative
Clinical narrative: This spontaneous report was received from a physician via company representative refers to several patients of unknown age. On an unknown date, the patient was vaccinated with a dose of RECOMBIVAX HB, (lot number, expiry date was unknown). On an unknown date, the patients failed to seroconvert with RECOMBIVAX. The outcome was unknown. Additional information is not expected.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Electromyogram, Facial paresis, Guillain-Barre syndrome, Hypoaesthesia, Immunoglobulin therapy
Clinical narrative: Numbness and weakness in bilateral upper and lower extremities. Loss of control in half of face. Symptoms started morning of 11/6/10 and became progressively worse. Diagnosed with Guillain Barre Syndrome. Required IVIG during hospital stay.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Lumbar puncture, Muscular weakness, Nuclear magnetic resonance imaging
Clinical narrative: Numbness and weakness in bilateral upper and lower extremities. Loss of control in half of face. Symptoms started morning of 11/6/10 and became progressively worse. Diagnosed with Guillain Barre Syndrome. Required IVIG during hospital stay.
Age: 81.0
Sex: M
Vaccine: PPV
Symptoms: Idiopathic thrombocytopenic purpura
Clinical narrative: Background: The currently recommended single dose of the PPSV23 for adults 65 years of age and older does not provide extended protection into older age. This reflects a significant unmet medical need for alternative strategies to protect older adults against pneumococcal infection, which may be met by the PCV13. Methods: We performed a randomized, modified double-blind trial in 936 adults aged 70 years and older who had previously received PPSV23 at least 5 years before entry and were now vaccinated with PCV13 or PPSV23. At 1 year after enrollment, all subjects received a follow-on dose of PCV13. Antipneumococcal opsonophagocytic activity (OPA) titers were measured before and at 1 month after each vaccination. Results: Following the enrollment vaccination, OPA titers were significantly greater in the PCV13 group compared to the PPSV23 group for 10 of the 12 serotypes common to both vaccines and to serotype 6A which is unique to PCV13. Responses were noninferior for the other 2 common serotypes. Responses to PCV13 given at 1 year were generally lower in the group that received PPSV23 at enrollment. Conclusion: In adults aged 70 years and older previously vaccinated with PPSV23, PCV13 was significantly more immunogenic than PPSV23 for most of the common serotypes and for serotype 6A. The OPA responses after a follow-on dose of PCV13 one year later indicate that a prior dose of PPSV23, but not PCV13, diminishes the response to the subsequent administration of PCV13. This report refers to a 81 year old male patient enrolled in a study. "At 1 year after enrollment, all subjects received a follow-on dose of PCV13. Antipneumococcal opsonophagocytic activity (OPA) titers were measured before and at 1 month after each vaccination." The 81-year-old male was in the group that received PPSV23 (manufacturer unknown) as the first dose and PCV13 as the second dose. 132 days after the second vaccination the patient experience idiopathic thrombocytopenic purpura (ITP) which was the only serious adverse event considered by the investigator to be related to the study vaccine. The ITP resolved after treatment. Additional information has been requested.
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV, PNC13
Symptoms: Autism, Decreased eye contact, Neurological symptom, Speech disorder
Clinical narrative: Son diagnosed with autism by 20 months. Eye contact diminished, speech diminished, neurological issues.
Sex: U
Vaccine: VARCEL
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacy student referring to a patient of unknown age and gender who on 13-AUG-2013, was vaccinated with a expired dose of VARIVAX, 0.5 ml, subcutaneous (lot# 0829AA, expiration date 02-JUN-2013). No adverse effect reported. This is one of two reports from the same reporter source. Additional information has been requested.
Age: 0.39
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Autism, Decreased eye contact, Diarrhoea, Nervous system disorder, Pyrexia
Clinical narrative: Vomiting, diarrhea, fever x 2 days following vaccinations, limited eye contact, no response to name, symptoms of Autism Neurological issues.
Age: 0.39
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Unresponsive to stimuli, Vomiting
Clinical narrative: Vomiting, diarrhea, fever x 2 days following vaccinations, limited eye contact, no response to name, symptoms of Autism Neurological issues.
Age: 17.0
Sex: M
Vaccine: HEPA, MNQ
Symptoms: Syncope
Clinical narrative: Case number PHEH2013US017479 is an initial spontaneous report received from the health care professional on 15 Aug 2013. This report refers to a 17-year-old male patient. His medical history and concomitant medication was not reported. He was vaccinated with MENVEO (batch number: A12123) intramuscularly and hepatitis A vaccine (unknown manufacturer, batch number: not reported) on 15 Aug 2013. On the same day, couple of minutes after vaccination, he fainted. The event outcome, seriousness and causality were not reported. No additional information was available.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Patient reaction felt by patient on 8/13/2013. Patient is stating itching and swollen, red and hot at the site of the injection.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Dyspnoea, Nausea
Clinical narrative: Two days after vaccine I awoke with extreme dizziness and a bit nauseous. Symptoms continued for 2-3 weeks. Symptoms are slowly dissipating. Also for the first few days, shortness of breath.
Age: 11.0
Sex: M
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Blister, Body temperature increased, Erythema, Local swelling, Malaise
Clinical narrative: "Woke up with a fever subjective treated with Ibuprofen, stayed from school today. This afternoon temp was 100 degrees F and arm was red and swollen. 2 hrs ago noticed there were blisters; subjectively not feeling well but eating okay. This AM mentioned throat hurt. Symptoms include no abdominal pain, no anorexia, no cough, fever, generalized myalgias, no nasal dic, no nausea, sore throat, and no vomiting".
Age: 11.0
Sex: M
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Myalgia, Oropharyngeal pain, Pyrexia
Clinical narrative: "Woke up with a fever subjective treated with Ibuprofen, stayed from school today. This afternoon temp was 100 degrees F and arm was red and swollen. 2 hrs ago noticed there were blisters; subjectively not feeling well but eating okay. This AM mentioned throat hurt. Symptoms include no abdominal pain, no anorexia, no cough, fever, generalized myalgias, no nasal dic, no nausea, sore throat, and no vomiting".
Age: 23.0
Sex: F
Vaccine: HEP
Symptoms: Muscle spasms, Swelling, Tenderness
Clinical narrative: Cramping in arm and hand - noticeable swelling (3rd Hep B) day after. Cramping started day vaccine was given 8-14-13. Still cramping today 8-16-13 but better - still small amount of swelling as well. No other vaccine given that day only TB test done in same arm. Sore to touch.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Fatigue, Rash, Sinus disorder
Clinical narrative: Rash to (L) arm, fatigue, sinus symptoms. ZYRTEC daily and OTC ibuprofen (MOTRIN).
Age: 13.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Rash, Rash pruritic, Urticaria
Clinical narrative: Rash R hand - Rash L arm - Hives both arms - itchy rash-started on hands moving up arms and elbows.
Age: 14.0
Sex: M
Vaccine: HEPA, HPV4, MEN
Symptoms: Seizure like phenomena
Clinical narrative: This case was reported by a healthcare professional, via a sales representative, and described the occurrence of seizure like activity in a 14-year-old male subject who was vaccinated with HAVRIX (GlaxoSmithKline). Concurrent vaccination included HPV vaccine (non-GSK); Merck; unknown; unknown given on 13 August 2013; meningococcal acwy vaccine (non-GSK); non-GSK manufacturer; unknown; unknown given on 13 August 2013. On 13 August 2013 the subject received unspecified dose of HAVRIX (.5 ml, unknown). On 13 August 2013, less than one day after vaccination with HAVRIX, the subject experienced seizure like activity. The healthcare professional reported the subject experienced seizure like activity (unknown symptoms) sometime after the injection in the office. The patient had "Mountain Dew and crackers, felt better, and the seizure activity resolved". This case was assessed as medically serious by GSK. On 13 August 2013, the event was resolved.
Age: 19.0
Sex: M
Vaccine: HEPAB
Symptoms: Erythema, Pruritus, Rash, Swelling
Clinical narrative: Swelling, itching, redness and rash; treated with Benadryl and cortisone cream.
Age: 1.36
Sex: M
Vaccine: PNC13
Symptoms: Confusional state, Heart rate increased, Hypotonia, Irritability, Lethargy
Clinical narrative: Woke from nap warm and irritable.  Running low grade fever.  By 7 PM temp was up to 101.  Administered Tylenol 5 mg and within minutes became lethargic, confused, limp.  Temp lowered to low grade.  2 am checked on him.  Very rapid heart beat, awake running temp 102.  Administered Advil 1 tsp and took to Emergency. Better on way to hospital.  Follow-up with doc in morning where he was spiking a fever again. Administered Advil to bring down.
Age: 1.36
Sex: M
Vaccine: PNC13
Symptoms: Pyrexia, Skin warm
Clinical narrative: Woke from nap warm and irritable.  Running low grade fever.  By 7 PM temp was up to 101.  Administered Tylenol 5 mg and within minutes became lethargic, confused, limp.  Temp lowered to low grade.  2 am checked on him.  Very rapid heart beat, awake running temp 102.  Administered Advil 1 tsp and took to Emergency. Better on way to hospital.  Follow-up with doc in morning where he was spiking a fever again. Administered Advil to bring down.
Age: 1.02
Sex: M
Vaccine: HEPA, MMRV
Symptoms: Pyrexia
Clinical narrative: Fever 101.
Age: 18.0
Sex: M
Vaccine: IPV, MMRV, MNQ, TDAP
Symptoms: Pyrexia
Clinical narrative: Fever of 102 for two days.
Age: 48.0
Sex: F
Vaccine: HEP
Symptoms: Arthralgia, Lumbar puncture, Muscular weakness, Nuclear magnetic resonance imaging spinal, Scan with contrast
Clinical narrative: SHE DEVELOPED BILATERAL HIP PAIN 2 DAYS AFTER RECEIVING 3RD DOSE OF HEPATITIS B VACCINE. THEN DEVELOPED LOWER EXTREMITY MUSCLE WEAKNESS 4 DAYS AFTER THE VACCINE. SHE WAS REFERRED TO HOSPITAL AND HAD AN MRI OF THE SPINE WITH CONTRAST AND THE LUMBAR PUNCTURE.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: 08/08/2013 Received telephone call from mother reporting that son's left deltoid area was swollen, red and itching. Already 3 days past vaccines, so was told to address itching with calamine.
Age: 26.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site warmth, Rash
Clinical narrative: Student received Tdap immunization on 8/14/13.  On 8/19/13 injection site became warm to touch, red and developed small bumps under arm.  No associated fever.  No visible abmornality at injection site, no tenderness. Small raised bumps on rim of axilla.
Age: 6.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Abnormal dreams, Diagnostic procedure, Narcolepsy, Somnolence, Weight increased
Clinical narrative: 2nd dose administered 01/13/2010 by Feb 2010 day time sleepiness, weight gain, vivid dreams resulting in countless tests finally revealing narcolepsy 8/9/2013.
Age: 1.52
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: 24 hours after receiving vaccine patient was noted by mom to have warmth, tenderness, and induration at site of varicella injection on posterior left arm. 48 hours patient cam in, and where injection was given, erythema 65x40mm, induration 25x30mm, located posterior left upper arm
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Pain & swelling - left deltoid & tricep, left arm warm to the touch at injection site, headache - all symptoms started at 8:00 PM on date of injection. Symptoms worsened to moderate level by 9:00 AM on 8/23.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Eye pruritus, Fatigue, Pruritus, Pyrexia, Rhinorrhoea
Clinical narrative: Phone call this a.m. from Mom with concerns that child may have had an allergic reaction to her vaccines. Mom said she was feeling absolutely fine when she came in for her 4yr PE on 8/19 and she got her 4yr vaccines and did fine with them. About 20min later in the car her face and eyes started itching and her nose started running. She was tired all day seemed more tired in the evening then ususal. She then spiked a fever during the night and vomited once last night and x1 this a.m. Mom said she seems fine now. Advised that child be seen in the office for eval. appt. given for later today. Pt was seen in the office on 8/20 @5:00 PM dx vomiting /vaccine reaction with obsevation no other treatment needed.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Vaccination complication, Vomiting
Clinical narrative: Phone call this a.m. from Mom with concerns that child may have had an allergic reaction to her vaccines. Mom said she was feeling absolutely fine when she came in for her 4yr PE on 8/19 and she got her 4yr vaccines and did fine with them. About 20min later in the car her face and eyes started itching and her nose started running. She was tired all day seemed more tired in the evening then ususal. She then spiked a fever during the night and vomited once last night and x1 this a.m. Mom said she seems fine now. Advised that child be seen in the office for eval. appt. given for later today. Pt was seen in the office on 8/20 @5:00 PM dx vomiting /vaccine reaction with obsevation no other treatment needed.
Age: 32.0
Sex: M
Vaccine: TDAP
Symptoms: Chills, Dizziness, Hyperaesthesia, Nausea, Pain
Clinical narrative: Dizziness followed by extreme achiness, chills and skin sensitivity to the touch.  Nausea followed.
Age: 19.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Dyskinesia, Posture abnormal
Clinical narrative: After 3 vaccines had been administered to patient, her head slumped forward, arms and legs began flailing.
Sex: F
Vaccine: HEP, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Convulsion, Somnolence
Clinical narrative: Seizure and then unable to wake for 12 hours.
Sex: F
Vaccine: HEP, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Abnormal faeces, Crying, Culture stool negative, Diarrhoea, Frequent bowel movements
Clinical narrative: Seizure and then unable to wake for 12 hours.
Sex: F
Vaccine: HEP, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Mucous stools, Radioallergosorbent test negative, Screaming, Vaccine positive rechallenge
Clinical narrative: Seizure and then unable to wake for 12 hours.
Age: 48.0
Sex: F
Vaccine: MMR
Symptoms: Injection site induration, Injection site pruritus, Injection site warmth
Clinical narrative: Itching and hard area at MMR injection site progressing to warmth at site on 8/21/13.
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Abdominal discomfort, Headache
Clinical narrative: Daily headaches and upset stomach since 8/17/13.
Age: 1.37
Sex: F
Vaccine: MMR
Symptoms: Rash
Clinical narrative: Patient started to develop little bumps on her face. It spread to her stomach and back then down to her legs.
Age: 51.0
Sex: M
Vaccine: HEP
Symptoms: Mobility decreased, Myalgia, Pain
Clinical narrative: Sore muscle. (Right Deltoid) After two days, pain did not subside. Difficulty raising right arm above head. Painful to push with right arm. Pain continued for two weeks and has not subsided except with pain reliever.
Age: 84.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Injection site erythema, Injection site vesicles, Pain, Pyrexia
Clinical narrative: Redness around injection site, fever, chills, body ache, blistering around injection site.
Age: 59.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema
Clinical narrative: Redness around injection site.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site rash, Pyrexia, Rash, Vomiting
Clinical narrative: Mom states child started having symptoms of vomiting the 3-4 hours after receiving vaccines. Vomiting continues for 5 hours and child developed fever of 101.5. Mom also states that child had developed a pox at the injection site of the MMRV and what looked like a rash on upper chest. Had to take to ER for fluids. Mom denies any illness in child prior to vaccine administration. No history of adverse reactions to vaccines.
Age: 17.0
Sex: M
Vaccine: TYP, YF
Symptoms: Headache, Malaise
Clinical narrative: MINOR COMPLAINED OF HEADACHE AND MALAISE.
Age: 21.0
Sex: M
Vaccine: MMR, MNQ, TDAP
Symptoms: Altered state of consciousness, Dizziness, Headache, Hyperhidrosis, Nausea
Clinical narrative: Phone call 07/25/13 from Patient saying at midnight he had a headache and body aches.  Took ibuprofen then.  Woke up dizzy, "almost blacked out" had nausea, vomiting, severe sweats, headache and felt like "needles pricking my body".
Age: 21.0
Sex: M
Vaccine: MMR, MNQ, TDAP
Symptoms: Pain, Paraesthesia, Vomiting
Clinical narrative: Phone call 07/25/13 from Patient saying at midnight he had a headache and body aches.  Took ibuprofen then.  Woke up dizzy, "almost blacked out" had nausea, vomiting, severe sweats, headache and felt like "needles pricking my body".
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Expired drug administered
Clinical narrative: Vaccine administration error.  The vaccine expired on 8/18/13.  The vaccine was given on 8/19/13.
Age: 64.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Injection site discomfort
Clinical narrative: Discomfort at injection site.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Vaccination complication
Clinical narrative: Began as redness around injection site in right deltoid and redness and swelling extended to 3-4 inches in diameter over next 24 hours. Mother took child to emergency room 8/10/2013 where doctor was trying to decide if cellulitis or vaccine reaction. Doctor prescribed antibiotics in case it was infection. Upon follow-up with PCP, it was decided most likely vaccine reaction to DTaP. Patient is completely better upon follow-up today 08/21/2013.
Age: 48.0
Sex: F
Vaccine: TD
Symptoms: Erythema, Injection site swelling, Oedema mouth, Pharyngeal oedema, Pruritus
Clinical narrative: Started with itching as I left clinic at around 12:45, progressed to hives. Swelling at injection, extreme itching (especially on wrist of the arm that the injection was given, swelling at hairline, scalp, mouth, tongue, throat, chest - redness similar to sunburn on nose, folds along side of nose leading to mouth. Doctor gave cortisone injection, symptoms began to improve starting about 40 minutes after injection and continued improvement over the next few hours.
Age: 48.0
Sex: F
Vaccine: TD
Symptoms: Swelling, Swollen tongue, Urticaria
Clinical narrative: Started with itching as I left clinic at around 12:45, progressed to hives. Swelling at injection, extreme itching (especially on wrist of the arm that the injection was given, swelling at hairline, scalp, mouth, tongue, throat, chest - redness similar to sunburn on nose, folds along side of nose leading to mouth. Doctor gave cortisone injection, symptoms began to improve starting about 40 minutes after injection and continued improvement over the next few hours.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Erythema, Feeling hot, Pain in extremity, Swelling
Clinical narrative: Warmth, significant swelling, redness and pain lt arm.
Age: 70.0
Sex: M
Vaccine: PNC13
Symptoms: Arthralgia, Back pain, Chills, Epistaxis, Injected limb mobility decreased
Clinical narrative: Shortly after receiving the vaccine client experienced fever, chills, sore arm, aching joints, backache, blood spotting after blowing nose. 4-5 days after he had redness and itching at injection site and generalized swelling on arm where vaccine was given. Also had decreased arm movement.
Age: 70.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Pain in extremity, Pyrexia
Clinical narrative: Shortly after receiving the vaccine client experienced fever, chills, sore arm, aching joints, backache, blood spotting after blowing nose. 4-5 days after he had redness and itching at injection site and generalized swelling on arm where vaccine was given. Also had decreased arm movement.
Age: 5.0
Sex: M
Vaccine: MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Pt with redness, swelling to left deltoid after PROQUAD injection. Injection adminsitered 2 days ago. First noted 1 day ago by mother. Seems to worsen overnight. 5" w x 4" L.
Age: 9.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site inflammation, Injection site pain, Injection site swelling
Clinical narrative: Entire upper left arm swollen, tender, inflammed Tdap administered in that location.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Alopecia, Blister, Erythema, Headache, Injection site erythema
Clinical narrative: Headache, itchy red blisters first at injection site, then over legs, arms, and back. Also, patient is experiencing hair loss approximately 1/3 of hair has been lost. Been going on since 6/28/2013 no treatment.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Injection site pruritus, Injection site vesicles, Pruritus
Clinical narrative: Headache, itchy red blisters first at injection site, then over legs, arms, and back. Also, patient is experiencing hair loss approximately 1/3 of hair has been lost. Been going on since 6/28/2013 no treatment.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Alopecia, Blister, Erythema, Headache, Pruritus
Clinical narrative: Headache, itchy red blisters first at injection site, then over legs, arms, and back. Also, patient is experiencing hair loss approximately 1/3 of hair has been lost. Been going on since 6/28/2013 no treatment.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Alopecia, Back pain, Blood test, Emotional distress, Headache
Clinical narrative: Headache, itchy red blisters first at injection site, then over legs, arms, and back. Also, patient is experiencing hair loss approximately 1/3 of hair has been lost. Been going on since 6/28/2013 no treatment.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Rash, Sciatica
Clinical narrative: Headache, itchy red blisters first at injection site, then over legs, arms, and back. Also, patient is experiencing hair loss approximately 1/3 of hair has been lost. Been going on since 6/28/2013 no treatment.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Hypersensitivity, Pharyngeal oedema, Throat irritation
Clinical narrative: Patient had an allergic reaction at night, she had throat swelling and itching She went to ER she was treated with PEPCID, BENADRYL and SOLU-MEDROL but SOLU-MEDROL did not help. Dr. gave her EPIPEN.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Blood glucose normal, Dizziness, Vomiting
Clinical narrative: HPV #1 administered 09:16 AM. 09-25 c/o dizziness and vomiting. VS = BP 114/63, P: 67, T 97.6, blood glucose: 119. MD examined patient - no noted lastingeffects. A/P: Adverse rxn to HPV vaccine. DC home. Push fluids, advance as tolerated.
Age: 0.18
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Dehydration, Diarrhoea
Clinical narrative: Diarrhea and dehydration.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Feeling hot, Injection site pain, Oedema, Pain
Clinical narrative: Rec'd. 5 yr. imm. on 8-19-13. FEver (102 max), redness, warmth and pain reported A.M. on 8-20-13. 'Better" per Mom at O.V. 8/21/13. 3" x 2.75" area of mild erythema, mild edema and TTP to (L) arm; 2" x 1" 4" area same s/s/ to (R) arm on exam (Tx: PRN, Ice and TYLENOL).
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Pyrexia
Clinical narrative: Rec'd. 5 yr. imm. on 8-19-13. FEver (102 max), redness, warmth and pain reported A.M. on 8-20-13. 'Better" per Mom at O.V. 8/21/13. 3" x 2.75" area of mild erythema, mild edema and TTP to (L) arm; 2" x 1" 4" area same s/s/ to (R) arm on exam (Tx: PRN, Ice and TYLENOL).
Age: 28.0
Sex: F
Vaccine: MNQ
Symptoms: Chills, Injection site pain, Pyrexia, Vomiting
Clinical narrative: Vomiting, fever, chills x36 hours; started post 12 hours from shot. 7 days arm still sore at site.
Age: 15.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Blood pressure increased, Dizziness, Heart rate increased, Hyperhidrosis, Hypoaesthesia
Clinical narrative: Client described numbness in (L) arm followed by tingling, coldness in hands and fingers. Client then described being lightheaded. Clients pulse and BP were elevated (P=84, BP=140/100) and was diaphoretic. Client laid down and recovered after about 45 minutes.
Age: 15.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Paraesthesia, Peripheral coldness
Clinical narrative: Client described numbness in (L) arm followed by tingling, coldness in hands and fingers. Client then described being lightheaded. Clients pulse and BP were elevated (P=84, BP=140/100) and was diaphoretic. Client laid down and recovered after about 45 minutes.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Local swelling, Pain in extremity
Clinical narrative: (R) arm pain and swelling 5 days after administration of GARDASIL vaccine. Possible late reaction to vaccine.
Age: 1.0
Sex: F
Vaccine: HEP, HEPA, MMR, PNC13, VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Administered Hep B #4 instead of HIB #4. No adverse reaction.
Age: 27.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Left deltoid - redness, swelling, pain 1 hr after injection given. Pt iced the (L) deltoid, took BENADRYL and ZYRTEC.
Age: 1.35
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV
Symptoms: Apnoea, Erythema, Rash, Swelling face, Urticaria
Clinical narrative: 16 mo male ex 25 weeker, O2 dependent, (+) central apnea. Pt was given IPV 3, DTaP 3, Hib 3, Hep B 2 and approx. 5-10 min later developed urticarial rash on face, swelling of face and redness of face spreading to trunk. No SOB/wheezing. He had no rxn to imms previously. Given epinephrine and Sx's resolved after 5-10 min.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to an unspecified number of patients. On an unspecified date in 2012, the patient was vaccinated (route not provided) with GARDASIL dose 2 (lot number and expiry date not provided). The Licensed Practical Nurse reported that since an unspecified date in 2012, an unspecified number of patients were administered the second and third dose in the GARDASIL series later than the recommendation in the prescribing information. No adverse effects were reported. The outcome of administered the second and third doses in the GARDASIL series later than the recommendation in the prescribing information and no adverse effects is unknown. The reporter considered administered the second and third doses in the GARDASIL series later than recommendation in the prescribing information and no adverse effects to be not related to GARDASIL. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: VARCEL
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 20 year old female patient. On 14-MAR-2013 the patient was vaccinated with VARIVAX dose 1 (lot number, dose, frequency not provided). The pharmacist reported that at the time of the report the patient had not yet received her second dose. No adverse event was reported. Additional information has been requested.
Age: 83.0
Sex: M
Vaccine: VARZOS, FLUX, VARZOS
Symptoms: Musculoskeletal pain, Neck pain, Pruritus, Swelling
Clinical narrative: This spontaneous report as received from a consumer refers to a 83 year old male patient. Patient medical history and drug reactions/allergies were none. Approximately on an unknown date in July 2013 (reported as 4-5 weeks ago), the patient was vaccinated with a dose of ZOSTAVAX (Lot number, expiry date, route and dose were not reported). Concomitant therapies included PRILOSEC. Approximately on an unknown date in 2013, the patient developed bump that started as itching on the back and changed to pain going up the shoulder and the neck. The patient sought no medical attention. No lab Diagnostics Studies was performed. No treatment was given for the events. The outcome of the reported events was not recovered/not resolved. Additional information is not expected.
Age: 83.0
Sex: M
Vaccine: VARZOS, FLUX, VARZOS
Symptoms: Acne, Injection site cyst, Injection site induration, Injection site pain, Injection site pruritus
Clinical narrative: This spontaneous report as received from a consumer refers to a 83 year old male patient. Patient medical history and drug reactions/allergies were none. Approximately on an unknown date in July 2013 (reported as 4-5 weeks ago), the patient was vaccinated with a dose of ZOSTAVAX (Lot number, expiry date, route and dose were not reported). Concomitant therapies included PRILOSEC. Approximately on an unknown date in 2013, the patient developed bump that started as itching on the back and changed to pain going up the shoulder and the neck. The patient sought no medical attention. No lab Diagnostics Studies was performed. No treatment was given for the events. The outcome of the reported events was not recovered/not resolved. Additional information is not expected.
Age: 83.0
Sex: M
Vaccine: VARZOS, FLUX, VARZOS
Symptoms: Injection site reaction
Clinical narrative: This spontaneous report as received from a consumer refers to a 83 year old male patient. Patient medical history and drug reactions/allergies were none. Approximately on an unknown date in July 2013 (reported as 4-5 weeks ago), the patient was vaccinated with a dose of ZOSTAVAX (Lot number, expiry date, route and dose were not reported). Concomitant therapies included PRILOSEC. Approximately on an unknown date in 2013, the patient developed bump that started as itching on the back and changed to pain going up the shoulder and the neck. The patient sought no medical attention. No lab Diagnostics Studies was performed. No treatment was given for the events. The outcome of the reported events was not recovered/not resolved. Additional information is not expected.
Age: 59.0
Sex: M
Vaccine: PPV
Symptoms: Cough, Oropharyngeal pain, Wheezing
Clinical narrative: This spontaneous report as received from a 59 year old male consumer with type II diabetes and high blood pressure who refers to himself. Then patient had none drug reactions/allergies. On 23-JUL-2013 the patient was vaccinated with a dose of PNEUMOVAX23 (dose, strength, site, lot #, route of administration not reported). Concomitant therapies included QNASL (80 mg). On 25-JUL-2013 the patient experienced wheezing, sore throat and coughing. Consumer did not seek any medical attention. No treatment was given for adverse event and no lab test performed. The outcome of wheezing, sore throat and coughing was reported as not recovered/not resolved. The relatedness between PNEUMOVAX23 and adverse events was not reported. Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Accidental exposure to product, Eye irritation, Eye pruritus
Clinical narrative: This spontaneous report received from a pharmacist of unknown age regarding self refers to a patient. The patient has FLAGYL allergy. The patient had no pertinent medical history. On 14-AUG-2013, the pharmacist while reconstituting and drawing up ZOSTAVAX, (lot number was J003359, expiry date 21-JUN-2014, route unknown) for a patient, she accidentally broke her needle and splashed about 0.3ml of reconstituted ZOSTAVAX onto her face and eyes. No concomitant medications were reported. On 14-AUG-2013, the patient experienced irritation and itchiness in her eyes. The patient did not take any treatment for the events. The patient did not seek medical attention. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B antibody negative
Clinical narrative: This spontaneous report was received from a registered nurse refers to a patient of unknown age. On an unknown date, the patient was vaccinated with a dose of RECOMBIVAX HB, (lot number, expiry date and route was not reported). On an unknown date, the patient had titers drawn which showed no immunity. The outcome was unknown. Additional information is not expected.
Sex: U
Vaccine: PPV
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender (no demographic details were provided). The patient's medical history was unknown. In May 2013, the patient was vaccinated with PNEUMOVAX23. Then, on 02-JUL-2013, the patient again received PNEUMOVAX23. No adverse effect was reported. Additional information has been requested.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 77 year old female patient. The patient's medical history included reaction/allergy to amoxicillin, AUGMENTIN. On about 02-AUG-2013 the patient was vaccinated with a dose of ZOSTAVAX, subcutaneous in her left upper arm (lot#, dose and frequency unspecified). Concomitant therapies included DIOVAN and COUMADIN. On about 10-AUG-2013, the patient "developed a rash-classic shingles on the left thigh". The patient went to the physician's office for medical attention. The patient was started VALTREX therapy on 13-AUG-2013. No lab diagnostics studies performed. The outcome of the event was reported as not recovered/not resolved. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age. The patient was administered the first dose of GARDASIL series on 15-MAY-2008, the second dose of 03-NOV-2011 and the third dose on 08-AUG-2013. No adverse effects were reported. The patient did not seek medical attention. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Dizziness
Clinical narrative: This spontaneous report as received from a Pediatrician participating in market research refers to a pre-adolescent female patient. On an unknown date the patient was vaccinated with her first dose of GARDASIL. Pediatrician reporting during interview that he observed "faintness and dizziness" in the patient after receiving first in a series of 3 injections of GARDASIL. Patient was taken to a nearby ER, where she recovered after a few hours and sent home. Date and other details of the patient were not recalled. Patient received the rest of the series without incident. The reporter considered faintness and dizziness to be related to GARDASIL. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, Pain
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse (L.P.N), refers to a female patient of unknown age, with unspecified seasonal allergies. The patient did not have a pertinent medical history. It was reported that in August 2010, reported as 3 years ago, the patient received the first dose of GARDASIL (lot # not reported) (dose and route not reported). Also, the patient received the second dose of GARDASIL (Lot # not reported) (dose and route not reported) in 2013, reported as on an unspecified date last week. There was no concomitant therapy. The reporter stated that after receiving the first dose of GARDASIL, the patient experienced unspecified pain (approximately in 2012). The patient did not receive a treatment for the adverse event and therapy with GARDASIL continued. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Age: 49.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 49 year old female patient. On an unknown date in 2003, the patient was vaccinated with first and second series of RECOMBIVAX HB, (lot number, expiry date and route was not reported). On an unknown date, the patients titers were drawn and patient showed no antibody response. There was no treatment provided. The outcome of titers was unknown. The patient did not seek medical attention. Additional information has been requested.
Age: 6.0
Sex: F
Vaccine: VARCEL
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 6 years old female patient. On 16-JUL-2013, the patient was vaccinated with the first dose of VARIVAX subcutaneous , and subsequently on 16-AUG-2013 the patient was vaccinated with the second dose of VARIVAX subcutaneous. No adverse effect reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Swelling
Clinical narrative: This spontaneous report as received from a female nurse (Certified Diabetes Educator (C.D.E)) of unknown age refers to herself. On an unknown date the nurse was vaccinated with a dose of ZOSTAVAX she had significant swelling and local injection site reaction that required antibiotics for treatment. The nurse reported it did completely resolve. The nurse did report a relatively significant even there. She also had difficulty with a tetanus vaccination. The outcome of "had difficulty with a tetanus vaccination" was unknown. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age (gender was unknown). On 16-AUG-2013 the patient was vaccinated with a dose of expired M-M-R II (lot 3 671320/1121AA, exp. date: 12-JUL-2013) (dose and route not reported) as vaccination. No adverse event reported. It was unknown if the patient sought medical attention or not. Additional information is not expected.
Age: 13.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Blister, Rash, Skin exfoliation, Skin wound
Clinical narrative: Fine rash to palms of hands and soles of feet; initial symptoms noticed by 8/17/13 approximately 2 days after vaccines Tdap and meningitis given. Fine eruptions visible and vesicles noted esp to feet with skin sloughing. Treatment provided for patient in office on 8/20/13: BENADRYL 25mg IM, SOLUMEDROL 40mg IM. Rx written KEFLEX 500mg #14 tab. Wound care provided to left great toe in office.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: VIIth nerve paralysis
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a 68 years old male patient. On an unknown date the patient was vaccinated with ZOSTAVAX (dose, route and lot number were not reported) for shingles vaccination. Concomitant medications were not reported. On an unknown date, a few weeks after getting ZOSTAVAX the patient developed bell's palsy. The outcome of bell's palsy was reported as recovered/resolved on an unspecified date. The relationship between ZOSTAVAX and the events was not reported. This case is linked to case 1308USA008729 via same reporter link. Additional information has been requested.
Age: 0.99
Sex: F
Vaccine: VARCEL
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse refers to a 11 month old female patient. On 09-NOV-2000, the patient was vaccinated with dose 1 of VARIVAX (merck) (lot#, expiry not reported) which was 5 days before the patient's first birthday. Nurse mentioned the patient received her second dose of VARIVAX (merck) (lot#, expiry not reported) on 10-SEP-2010. No adverse symptoms reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse regarding a patient of unknown age and gender with no pertinent medical history reported. The registered nurse reported that on 13-AUG-2013, one patient was vaccinated with an improperly stored dose of VAQTA (lot # H012673 expiration date 27-FEB-2015) (dose and route not specified), that was exposed to 31F for 72 hours, which is an unsupported excursion noted by in-house stability data. No adverse symptoms reported. The nurse also reported that another patient was vaccinated with improperly stored VAQTA (MARRS 1308USA009656), another patient was vaccinated with improperly stored PEDVAX (MARRS 1308USA009657), another patient was vaccinated with improperly stored ROTATEQ (MARRS 1308USA009659), and another one was vaccinated with improperly stored GARDASIL (Intramuscular Injection) (MARRS 1308USA009658). This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist, concerning a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies were not provided. On 19-JUL-2013 the patient received a dose of PNEUMOVAX23 vial, (dose, route, lot number and expiration date were not provided). Co-suspect therapy and concomitant medications were not provided. It was reported that on 01-AUG-2013, the patient received another dose of PNEUMOVAX23 (dose, route, lot number and expiration date were not provided). No adverse effects were reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Polycystic ovaries
Clinical narrative: This spontaneous report as received from a physician's assistant refers to a female patient of unknown age. On an unknown dates the patient received all 3 shots in GARDASIL series. On an unknown date the patient's mother reported that GARDASIL had caused the patient to have polycystic ovary syndrome (PCOS). The patient did not seek medical attention. The outcome of the event was unknown. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 23 year old female patient. On 18-AUG-2013, the patient was vaccinated with an expired dose of GARDASIL (lot # 669285/0691AA, expiry: 17-AUG-2013) dose 3. No adverse effect reported. Additional information has been requested.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus, Rash erythematous, Rash macular, Skin lesion
Clinical narrative: This spontaneous report as received from a 61 year old male patient with no known drug reaction/allergies, and no other pertinent medical history, refers to himself. On 20-JUL-2013 the patient was vaccinated with a dose of ZOSTAVAX. There was no concomitant medication. On 27-JUL-2013, a week after receiving the ZOSTAVAX vaccine, the patient notice lesion on right leg, ankle to knee, inner leg, and on both arms with red spots. He reported it was very itchy and then turned into blotches. The patient did not seek medical attention. No lab diagnostic tests were performed. He had been treating with topical ointment like for poison ivy which he thought he had originally until he read about ZOSTAVAX vaccine online. The outcome of the events was unknown. The causal relationship was not reported. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, VIIth nerve paralysis
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a 64 years old female patient. The patient's medical history included bell palsy. On an unknown date the patient was vaccinated with ZOSTAVAX (dose, route and lot number were not reported) for shingles vaccination. Concomitant medications were not reported. On an unknown date, 2-3 weeks after received ZOSTAVAX the patient developed bell's palsy. Patient received unspecified prescription drug as treatment for the bell's palsy. The outcome of bell's palsy was reported as not recovered/not resolved. The relationship between ZOSTAVAX and the events was not reported. Patient spoke with the physician. This case is linked to case 1308USA009652 via same reporter link. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse regarding a patient of unknown age and gender with no pertinent medical history reported. The registered nurse reported that on 14-AUG-2013 one patient was vaccinated with an improperly stored dose of VAQTA (lot # H010659 expiration date 01-MAR-2015) (dose and route not specified), that was exposed to 31F for 72 hours, which was an unsupported excursion noted by in-house stability data. No adverse symptoms reported. The nurse also reported that another patient was vaccinated with improperly stored VAQTA (MARRS 1308USA008790), another patient was vaccinated with improperly stored PEDVAX (MARRS 1308USA009657), another patient was vaccinated with improperly stored ROTATEQ (MARRS 1308USA009659), and another one was vaccinated with improperly stored (Intramuscular injection) GARDASIL (MARRS 1308USA009658). This is one of several reports from the same reporter. Additional information has been requested.