chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 9.0
Sex: M
Vaccine: RAB, RAB
Symptoms: Pyrexia, Rash
Clinical narrative: Case number PHHY2012US117700 is an initial spontaneous report received from a pharmacist on 13 Dec 2012: This report refers to a 9-year-old male patient. He was vaccinated with the third dose of RABAVERT on 14 Apr 2012 following which she experienced fever (see related case: PHEH2012US024846). He was further on vaccinated with the fourth dose of RABAVERT (batch number: 473011C) intramuscularly on 24 Apr 2012 (the fourth dose was postponed due to the reaction after the third injection).  24 hours after the vaccination, he reported pain in joints and knees. Swelling developed in his feet and knees on 27 Apr 2012 (which the reporter initially thought was because of soccer). On 28 Apr 2012, swelling spread to the elbows. The swelling became so severe that he was unable to walk. On 29 Apr 2012,  he was brought to the emergency room with a rash of small dots on his legs and he was then diagnosed with Henoch-Schonlein purpura.  The child was doing well at the time of this report. However final outcome of the events was reported as unknown. No further information about seriousness and causality was provided.
Age: 34.0
Sex: F
Vaccine: FLUX, TDAP, FLU3, TDAP
Symptoms: Arthralgia, Blood test abnormal, Rheumatoid arthritis
Clinical narrative: Developed joint pain in numerous areas of body. Went to RA doctor for blood tests. Came back positive for Rheumatoid Arthritis. Never had any joint problems before getting flu shot. This was first time ever receiving flu shot.
Age: 34.0
Sex: F
Vaccine: FLUX, TDAP, FLU3, TDAP
Symptoms: Arthralgia, Rheumatoid arthritis
Clinical narrative: Developed joint pain in numerous areas of body. Went to RA doctor for blood tests. Came back positive for Rheumatoid Arthritis. Never had any joint problems before getting flu shot. This was first time ever receiving flu shot.
Age: 80.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Blood pressure decreased, Guillain-Barre syndrome, Hypoaesthesia, Plasmapheresis, Walking aid user
Clinical narrative: Sore arm and shoulder for several days after the vaccine. A month after numbness in feet started. Doctor had MRI and EMR performed suspected GBS. By 11/10 could only walk a bit. Went to doctor on 11/12/12 doctor administered FLUVAX and checked numbness. Was hospitalized on 11/16/12, neurologist also checked for GBS. Received 5 days of treatment for plasmapheresis. Rehab started on 11/21 released by 12/5, condition improving. Nurse and physical therapist have visited home to provide care. At one point pt was using wheelchair and/or walker.
Age: 80.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Gait disturbance, Guillain-Barre syndrome, Hypoaesthesia, Laboratory test, Musculoskeletal pain
Clinical narrative: Sore arm and shoulder for several days after the vaccine. A month after numbness in feet started. Doctor had MRI and EMR performed suspected GBS. By 11/10 could only walk a bit. Went to doctor on 11/12/12 doctor administered FLUVAX and checked numbness. Was hospitalized on 11/16/12, neurologist also checked for GBS. Received 5 days of treatment for plasmapheresis. Rehab started on 11/21 released by 12/5, condition improving. Nurse and physical therapist have visited home to provide care. At one point pt was using wheelchair and/or walker.
Age: 80.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Nuclear magnetic resonance imaging abnormal, Pain in extremity, Plasmapheresis, Walking aid user, Wheelchair user
Clinical narrative: Sore arm and shoulder for several days after the vaccine. A month after numbness in feet started. Doctor had MRI and EMR performed suspected GBS. By 11/10 could only walk a bit. Went to doctor on 11/12/12 doctor administered FLUVAX and checked numbness. Was hospitalized on 11/16/12, neurologist also checked for GBS. Received 5 days of treatment for plasmapheresis. Rehab started on 11/21 released by 12/5, condition improving. Nurse and physical therapist have visited home to provide care. At one point pt was using wheelchair and/or walker.
Age: 54.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Condition aggravated, Enterocolitis bacterial
Clinical narrative: Patient reported receiving medical treatment for bacterial colitis (on 12-14-12 pt received Rx for Clindamycin 300mg 1 three times daily).
Age: 51.0
Sex: F
Vaccine: FLUX
Symptoms: Fall, Paralysis
Clinical narrative: Within a few hours I fell on the floor unable to move paralyzed from my chest down. I spent 1 wk in the hospital the rest of Nov in a skilled nursing home - Rehab
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Anaphylactic reaction, Dysphagia, Throat tightness
Clinical narrative: Couldn't swallow. Pt's "throat" was closing. Had to go to ER for anaphylactic event. Given SOLU-MEDROL, BENADRYL, Cortisone, ZANTAC, PEPCID, Prednisone. Was able to leave ER around 1 AM.
Age: 65.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Blood creatine phosphokinase, Fatigue, Metabolic function test, Myalgia, Red blood cell sedimentation rate normal
Clinical narrative: Several days after injection began to experience moderate myalgias, fatigue especially to deltoid regions. No fever, tingling or weakness to lower extremities.
Age: 0.35
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Pyrexia, Vomiting
Clinical narrative: Shots given Wednesday Dec 19, 12. Developed a fever 101.8 by 9 PM. She was given TYLENOL and 45 minutes later the fever was up to 102 rectally. Mother call on cal land was instructed to give MOTRIN which she did and baby promptly vomited the MOTRIN up. She was fine by Friday Dec 21, 12.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Mobility decreased, Pain in extremity
Clinical narrative: Shot administered at 310pm. Pt called at 515pm stating arm was in severe pain & she "could not lift it". She said the actual injection hurt her & didn't fell like a typical shot.
Age: 91.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Injection site pruritus, Injection site warmth
Clinical narrative: Patient rec. FLUVIRIN in (R) arm on 11/14/12 states arm feels warm, itchy. Has felt this way once rec. shot & still feels this way. Not getting any worse. Also, rec. BOOSTRIX in (L) arm that day - no issues.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Eye swelling, Influenza like illness, Oedema peripheral
Clinical narrative: Same day of vaccine administration, pt reported swelling of hands, feet, eyes. Also, developed flu-like symptoms. Referred to her PCP.
Age: 1.05
Sex: F
Vaccine: FLU3, HEPA, PNC
Symptoms: Body temperature increased, Convulsion, Upper respiratory tract infection
Clinical narrative: 12 mos old female with low grade temp, URI was given vaccines 930AM tactile temp at home then approximately 7 PM seizure approximately 5 minutes nonfocal no fever in ER O2 sats 100%. (Given TYLENOL 330PM).
Age: 13.0
Sex: F
Vaccine: FLU3
Symptoms: Influenza, Influenza B virus test positive
Clinical narrative: Positive influenza type B after influenza vaccine on 10/20/2012. TAMIFLU given.
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site reaction, Injection site warmth, Skin lesion
Clinical narrative: Red, warm, flat lesion, 6 cm x 7 cm to left upper thigh. No pain to touch.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Skin disorder
Clinical narrative: I was approached by a customer today in regards to her flu shot received on 10/23/12. She showed me a large depression/void on the outer side of her bicep and indicated that this occurred as a result of her flu shot.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site exfoliation, Upper extremity mass
Clinical narrative: Patient reported that her arm still has a red mark where the shot was given, that she can still feel a lump inside of her arm, and that a piece of skin where the vaccine was given had fallen off of her skin.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site urticaria, Injection site warmth
Clinical narrative: Welt at injection site for about 1 week.  Itching at injection site.  Warm to touch at injection site.
Age: 21.0
Sex: M
Vaccine: SMALL
Symptoms: Injection site rash, Rash maculo-papular, Urticaria
Clinical narrative: Rash at inoculation site, also maculopapular eruption w/ one urticarial area.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Joint stiffness
Clinical narrative: Stiffness and pain at joint near injection site.
Age: 13.0
Sex: M
Vaccine: FLUN3, HPV4, MNQ
Symptoms: Dyspnoea, Eye swelling, Nausea, Rhinorrhoea, Swelling face
Clinical narrative: Pt c/o nausea and nasal discharge.  Then developed swelling around face and eyes with development of hives on face.  He then reported difficulty breathing.  Sympoms resolved after administration of Benadryl 50mg PO and Prednisone 20mg PO. EMS called and patient transported to ED in stable condition.
Age: 13.0
Sex: M
Vaccine: FLUN3, HPV4, MNQ
Symptoms: Urticaria
Clinical narrative: Pt c/o nausea and nasal discharge.  Then developed swelling around face and eyes with development of hives on face.  He then reported difficulty breathing.  Sympoms resolved after administration of Benadryl 50mg PO and Prednisone 20mg PO. EMS called and patient transported to ED in stable condition.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Fatigue, Feeling hot, Hemiplegia, Hypoaesthesia
Clinical narrative: I received three sets of the HPV vaccination via recommendation. Approximately a month or so after receiving the first vaccination, the first incident/possible reaction occurred. The first reaction was the temporary paralysis/numbness of my right arm. The numbness happened instantly without my knowing it. I realized it was numb when I moved my arm and scared myself because I did not feel my arm move towards my face. Other symptoms during this incident included feeling weary and lightheaded to the point where I needed to rest for a few moments. The incident lasted for approximately 10 minutes and was over after I sat down and drank water. The second, last, and most severe incident occurred a few weeks after the first incident. The second incident occurred while I was looking at a computer screen and my right fingertips started to become numb. The numbness lasted over maybe 10 minutes and over time, the numbness went from my fingertips up my right arm/shoulder and down my right thigh and leg. Along with the temporary paralysis of the right side of my body, I had blurred vision in both eyes, lightheadedness, felt overheated,  and had to lay down because I did not feel stable enough sitting up. After my vision came back to me normal and I felt a little bit better, I was driven to the local hospital where I was "officially" diagnosed with migraines and given 3 different medications that would help my symptoms. Prior to the HPV shot, I had migraines and headache often but never did I have the symptoms or similar symptoms close to what I had after receiving the HPV shot. After receiving the second and third dose of the HPV shot series and to this day I have not experienced those symptoms except the temporary numbness in my right fingertips or forearm (this may or may not be from the shot) which comes here and there but nothing stresfful or frequent. The doctor who treated me at the local hospital said from a personal and non-official opinion that he believed the reaction and symptoms were from the HPV shot, not migraines, but from a medical professional stand, he could not state that opinion.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Migraine, Monoplegia, Vision blurred
Clinical narrative: I received three sets of the HPV vaccination via recommendation. Approximately a month or so after receiving the first vaccination, the first incident/possible reaction occurred. The first reaction was the temporary paralysis/numbness of my right arm. The numbness happened instantly without my knowing it. I realized it was numb when I moved my arm and scared myself because I did not feel my arm move towards my face. Other symptoms during this incident included feeling weary and lightheaded to the point where I needed to rest for a few moments. The incident lasted for approximately 10 minutes and was over after I sat down and drank water. The second, last, and most severe incident occurred a few weeks after the first incident. The second incident occurred while I was looking at a computer screen and my right fingertips started to become numb. The numbness lasted over maybe 10 minutes and over time, the numbness went from my fingertips up my right arm/shoulder and down my right thigh and leg. Along with the temporary paralysis of the right side of my body, I had blurred vision in both eyes, lightheadedness, felt overheated,  and had to lay down because I did not feel stable enough sitting up. After my vision came back to me normal and I felt a little bit better, I was driven to the local hospital where I was "officially" diagnosed with migraines and given 3 different medications that would help my symptoms. Prior to the HPV shot, I had migraines and headache often but never did I have the symptoms or similar symptoms close to what I had after receiving the HPV shot. After receiving the second and third dose of the HPV shot series and to this day I have not experienced those symptoms except the temporary numbness in my right fingertips or forearm (this may or may not be from the shot) which comes here and there but nothing stresfful or frequent. The doctor who treated me at the local hospital said from a personal and non-official opinion that he believed the reaction and symptoms were from the HPV shot, not migraines, but from a medical professional stand, he could not state that opinion.
Age: 38.0
Sex: M
Vaccine: FLU3
Symptoms: Arthritis, Autoimmune disorder, Fatigue, Granuloma, Pneumonia
Clinical narrative: Auto-immune symptoms, Raynaud's, arthritis, pneumonia, granulomas, skin lesions, fatigue, fever.
Age: 38.0
Sex: M
Vaccine: FLU3
Symptoms: Pyrexia, Raynaud's phenomenon, Skin lesion
Clinical narrative: Auto-immune symptoms, Raynaud's, arthritis, pneumonia, granulomas, skin lesions, fatigue, fever.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Dysstasia, Dysuria, Guillain-Barre syndrome, Hypoaesthesia, Intensive care
Clinical narrative: Pt presented initially w/numbness in hands & arms. Pt was sent to neurologist & initially dx as suffering from stress. In am of 12/23/12 friend reported pt could not urinate or stand well & was instructed to take pt to hospital.  Upon arrival in afternoon, pt was admitted to ICU & placed on ventilator w/dx of Guillain-Barre.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Mechanical ventilation, Stress
Clinical narrative: Pt presented initially w/numbness in hands & arms. Pt was sent to neurologist & initially dx as suffering from stress. In am of 12/23/12 friend reported pt could not urinate or stand well & was instructed to take pt to hospital.  Upon arrival in afternoon, pt was admitted to ICU & placed on ventilator w/dx of Guillain-Barre.
Age: 0.51
Sex: M
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Decreased appetite, Diarrhoea, Vomiting
Clinical narrative: Started with vomiting repeatedly throughout night, every hour or so roughly until 5AM. Had Diarrhea throughout following day, with decreased appetite. Typical daily consumption is 28-32oz and today he has only eaten 15oz.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Maternal exposure during pregnancy, Rash, Throat irritation
Clinical narrative: (L) ear rash, face, chest, belly rash. Throat itching, took 4 days of BENADRYL 25mg.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: Patient developed left/unilateral tender lymphadenopathy of axilla w/o clinical evidence of cellulitis or breast pathology approximately 24 hours after receiving influenza vaccine in left deltoid.
Age: 60.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: In chart note. Patient had a pneumonia shot on Friday, and is having a reaction around the injection site. The area started to swell on Saturday and swelling and redness moved down her arm. She says that it's starting to get better but would like a call from a nurse to discuss.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling hot, Oedema peripheral, Pruritus
Clinical narrative: Patient had swollen arm size of 3 inches across w/emanating heat & itching. She put ice on it and took BENADRYL tablets and swelling went down next day considerably.
Age: 50.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Joint swelling, Oedema peripheral, Pain in extremity, Pyrexia
Clinical narrative: 11/9 at 1120: TC from pt. Did have a fever for a couple days. Did not take temp. Injection was in L arm. Arm got swollen and hot and swelled up and now is moving down his arm. There is some swelling around elbow. It is still hot and red. Pain is lessening.
Age: 50.0
Sex: M
Vaccine: PPV
Symptoms: Skin warm
Clinical narrative: 11/9 at 1120: TC from pt. Did have a fever for a couple days. Did not take temp. Injection was in L arm. Arm got swollen and hot and swelled up and now is moving down his arm. There is some swelling around elbow. It is still hot and red. Pain is lessening.
Age: 83.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity
Clinical narrative: In chart note. She states she got a PNEUMOVAX here at the clinic a week ago. The following day her left arm was quite painful. It has persisted that time. She has noted no redness of the arm. She had had no fever or chills. She has no other muscle pain. No hx of trauma. No new medications.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Bursitis
Clinical narrative: (R) shoulder bursitis seen 11/8/12 & 11/12/12 then to orthopedist 11/16/12.
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Syncope
Clinical narrative: Patient stated experienced syncope on 12/7/12 and 12/14/12 which she believes is related to flu shot.
Age: 4.0
Sex: M
Vaccine: DTAP, FLU3, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site inflammation, Pyrexia
Clinical narrative: Large, red, inflamed, indurated area on (R) thigh fever 102.
Age: 27.0
Sex: M
Vaccine: FLU3
Symptoms: Axillary pain, Chest pain, Electrocardiogram, Injection site pain, Pain
Clinical narrative: Beginning day following vaccination, patient began experiencing shooting pain down his right arm. Pain comes & goes. Location of pain is from left shoulder to elbow and hand. Occasional pain in armpit and chest. Some bruising at vaccine administration site. No redness or swelling reported.
Age: 27.0
Sex: M
Vaccine: FLU3
Symptoms: Pain in extremity, Vaccination site haematoma
Clinical narrative: Beginning day following vaccination, patient began experiencing shooting pain down his right arm. Pain comes & goes. Location of pain is from left shoulder to elbow and hand. Occasional pain in armpit and chest. Some bruising at vaccine administration site. No redness or swelling reported.
Age: 1.22
Sex: F
Vaccine: DTAP, FLU3
Symptoms: Rash
Clinical narrative: Rash on torso. Started within 1 day was worst at 5-6 days. Slowly going away with BENADRYL.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain
Clinical narrative: Received the shot in 2010 - in Aug. 2012 I came down with shingles - and still have some effects and pain in December-the shot did not prevent the shingles or shorted duration. I feel the shot is overpriced as it is not that effective.
Age: 23.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Injection site haematoma, Pruritus, Urticaria
Clinical narrative: Employee received vaccine 1300 hrs. on Mon. 11-19-12. "Mid-morning" on Tuesday, 11-20-12, she developed red "hive" about 2 inches in diameter. It was itchy, but no pain. There also was a purple bruise "about size of silver dollar" at injection site. On Wed. at 4 pm she saw Dr., an associated of her PCP, Cephalexin ordered x 10 days. Resolved. She notified EH after 2nd dose ordered on 12/17/12 - not given.
Age: 26.0
Sex: M
Vaccine: HEPA, TDAP, TYP
Symptoms: Convulsion, Immediate post-injection reaction, Loss of consciousness
Clinical narrative: After giving the Typhoid inj. & Tdap in patient's left arm, I gave the Hep A in his right deltoid. Immediately after receiving the Hep A, patient went unconscious & had a seizure. Was unconscious for less than 1 minute. Fully recovered.
Age: 29.0
Sex: F
Vaccine: VARCEL
Symptoms: Extensive swelling of vaccinated limb, Injection site pain, Local reaction
Clinical narrative: Excessive swelling in pt (L) arm. Localized to injection area only. Pt instructed to take 50 mg diphenhydramine and continue q 6 hours until swelling stops. Pt saw PA on 12/13 instructed to continue diphenhydramine. Arm still swollen with pain radiating from injection site.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Activities of daily living impaired, Injection site pain, Insomnia
Clinical narrative: Pt had difficulty putting on his pajamas, he complained of pain in his Rt shoulder where the shots were given. Mother reports administering ibuprofen several times but pt had difficulty sleeping. No fevers and no previous hx of reaction to sensation.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Cyanosis, Drooling, Loss of consciousness, Seizure like phenomena
Clinical narrative: Approx. 7 mins after rcig vaccine, pt. with LOC, seizure like activity , cyanosis, drooling, lasting approx 2-3 mins.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Injection site infection, Swelling
Clinical narrative: Noted swelling and redness on eve of 12-18-12. Pt. was taken to ED where he was given an antibiotic for localized infection 9site) and BENADRYL.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Rash erythematous
Clinical narrative: Patient reported to us and to physician "baseball" size red rash with vesicles.
Age: 38.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Injection site macule, Injection site pruritus, Rash
Clinical narrative: Mildly pruritic macular rash on left shoulder (vacc. admin. site) 3-5 days after vaccine administration. Rash then spread to chest, upper back, Rt. upper shoulder.
Age: 0.35
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Body temperature increased
Clinical narrative: Seen in ER same day as vaccines were given. C/O Temp 102.5 at home.
Age: 88.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Erythema, Injection site haematoma, Oedema peripheral
Clinical narrative: Bruise at injection site, entire arm red & swollen. Still swollen (red going away).
Age: 65.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Injection site erythema
Clinical narrative: Localized erythema at injection site, as well as tricep region significant pain / no fever or generalized myalgia.
Age: 1.54
Sex: M
Vaccine: DTAP
Symptoms: Pyrexia
Clinical narrative: Pt. started with fever shortly following DTaP vaccine.
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Oedema peripheral, Skin discolouration
Clinical narrative: Vaccine 12-18-12. On 12-21-12 from upper mid shoulder to elbow swollen and red,. On 12-24-12, black and brown coloring near elbow.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Neck pain
Clinical narrative: Cervicalgia; Lumbago.
Age: 1.01
Sex: F
Vaccine: FLU3, HIBV, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site reaction, Injection site swelling, Injection site urticaria
Clinical narrative: At the moment of injection the area around the injection site became blanched, it took ~1 min for the blanching to resolve, then the area became red & swollen & hard to the touch. Within 2min hives appeared around the site. She was given 6.25mg BENADRYL within 3min.
Age: 1.01
Sex: F
Vaccine: FLU3, HIBV, PNC13, VARCEL
Symptoms: Pallor
Clinical narrative: At the moment of injection the area around the injection site became blanched, it took ~1 min for the blanching to resolve, then the area became red & swollen & hard to the touch. Within 2min hives appeared around the site. She was given 6.25mg BENADRYL within 3min.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Malaise, Pain
Clinical narrative: Patient stated she experienced 3 hours of intense pain, headache, violently ill.
Sex: U
Vaccine: MMR
Symptoms: Abnormal behaviour
Clinical narrative: This spontaneous report as received from a consumer on behalf of daughter refers to many of her friend's children (anonymous). On an unspecified date the patients were vaccinated with M-M-R II (lot # not reported). On an unknown date the patients have had behavioral changes after receiving the vaccinations. The outcome of behavioral changes were unknown. Additional information is not expected.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 58 years old female patient who on 03-DEC-2012, was vaccinated with an expired dose of ZOSTAVAX 0.65 ml subcutaneously in left arm (lot # 671004/0729AA, Exp: 17-AUG-2012). No adverse effects reported. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Discomfort, Headache, Injection site erythema, Injection site pruritus, Rash erythematous
Clinical narrative: This spontaneous report has been received from a 64 years old female consumer with allergy to shellfish and allergy to sulfa medications. This patient was vaccinated with ZOSTAVAX (dose and route were not reported) on 27-NOV-2012. No other co-suspects were reported. Concomitant medications included: PREDNISON. On 01-DEC-2012 the patient experienced redness and itching at the injection site, mild discomfort and slight headache. After of left forearm upper arm itchy red bumps, accompanied by "heat". The patient was treated for the events. The outcome of mild discomfort, left forearm upper arm itchy red bumps, slight headache, itching at injection site, redness at injection and heat is unknown. The relatedness for redness at injection site, heat, left forearm upper arm itchy red bumps, slight headache, mild discomfort and itching at injection site was not reported for ZOSTAVAX. Additional information is not expected.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin warm
Clinical narrative: This spontaneous report has been received from a 64 years old female consumer with allergy to shellfish and allergy to sulfa medications. This patient was vaccinated with ZOSTAVAX (dose and route were not reported) on 27-NOV-2012. No other co-suspects were reported. Concomitant medications included: PREDNISON. On 01-DEC-2012 the patient experienced redness and itching at the injection site, mild discomfort and slight headache. After of left forearm upper arm itchy red bumps, accompanied by "heat". The patient was treated for the events. The outcome of mild discomfort, left forearm upper arm itchy red bumps, slight headache, itching at injection site, redness at injection and heat is unknown. The relatedness for redness at injection site, heat, left forearm upper arm itchy red bumps, slight headache, mild discomfort and itching at injection site was not reported for ZOSTAVAX. Additional information is not expected.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to unknown number of patients of unspecified age and gender who on unknown dates received M-M-R II (doses, routes and lot numbers not reported) exposed to 11 C for 96 hours. No adverse effect reported. This is one of several reports received from the same source (related MARRS numbers 1212USA004999, 1212USA008807). Attempts are being made to distinguish individual patients mentioned in this report.
Age: 57.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Injection site cellulitis, Injection site pain, Pyrexia
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 57 year old female patient. Concurrent condition included allergy to sulfa, cephalosporins and for eggs. On 10-DEC-2012 the patient was vaccinated with PNEUMOVAX23. The lot number of the dose of vaccine was illegible on the scanned copy that the nurse practitioner has available, but she states that the lot number appears to be either H018940 or H018440. The dose and route of administration were not provided. No other co-suspects were reported. No concomitant medications were reported. On 10-DEC-2012 the patient experienced soreness from the injection site to her axilla. On 11-DEC-2012 the patient experienced rigors and chills and fever of 100.8. On 12-DEC-2012 the injection site looked like she was developing cellulitis. The nurse practitioner prescribed doxycycline and ADVIL and will continue to monitor the patient. The outcome of soreness from the injection site to her axilla, injection site looks like she is developing cellulitis, fever of 100.8 and rigors and chills was reported as not recovered/not resolved. The relatedness for soreness from the injection site to her axilla, injection site looks like she is developing cellulitis, rigors and chills and fever of 100.8 is unknown for PNEUMOVAX23. Additional information has been requested.
Age: 55.0
Sex: M
Vaccine: FLU3
Symptoms: Rash, Urticaria
Clinical narrative: Welts, Rash.
Age: 13.0
Sex: M
Vaccine: FLUN3
Symptoms: Asthenia, Loss of consciousness, Syncope, Tinnitus
Clinical narrative: Extreme weakness; Fainted; Loud ringing in ears after regaining consciousness for 5 minutes.
Age: 15.0
Sex: F
Vaccine: FLUN3
Symptoms: Asthenia, Dizziness, Hearing impaired, Malaise, Nasopharyngitis
Clinical narrative: Felt dizzy; Turned white all over; blurred vision; hearing impaired; felt faint; felt weak and sick for next several days; had cold symptoms next several days.
Age: 15.0
Sex: F
Vaccine: FLUN3
Symptoms: Pallor, Vision blurred
Clinical narrative: Felt dizzy; Turned white all over; blurred vision; hearing impaired; felt faint; felt weak and sick for next several days; had cold symptoms next several days.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to unknown number of patients of unspecified age and gender who on unknown dates received LIQUID PEDVAXHIB (doses, routes and lot numbers not reported) exposed to 11 C for 96 hours. No adverse effect reported. This is one of several reports received from the same source (related MARRS numbers: 1212USA004999, 1212USA008808). Attempts are being made to distinguish individual patients mentioned in this report.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a registered pharmacist refers to a female patient of unknown age. The patient's medical history included chicken pox as a child. The patient was vaccinated with a 0.65 ml dose of ZOSTAVAX on 26-DEC-2011. No other co-suspects were reported. No concomitant medications were reported. In March or April of 2012, the patient developed a spot of shingles, and a mild case of shingles in November 2012. The patient sought unspecified medical attention. The outcome of a spot of shingles and a mild case of shingles was unknown. Additional information has been requested.
Age: 38.0
Sex: M
Vaccine: PPV, FLU3, PPV
Symptoms: Cellulitis, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Fever of 102.0 and rash reported by patient to office approx 10 hours after receiving vaccine. Then developed cellulitis at injection site and went to ER 11/4/12.
Age: 38.0
Sex: M
Vaccine: PPV, FLU3, PPV
Symptoms: Culture negative, Injection site cellulitis, Pyrexia, Rash
Clinical narrative: Fever of 102.0 and rash reported by patient to office approx 10 hours after receiving vaccine. Then developed cellulitis at injection site and went to ER 11/4/12.
Age: 44.0
Sex: M
Vaccine: FLUX
Symptoms: Hypoaesthesia, Injection site reaction, Muscle spasms, Myalgia
Clinical narrative: I experienced intramuscular soreness at site of influenza vaccine along with minor muscle spams in forearm and upperarm. I then started experiencing numbness on the dorsal side of my thumb.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site urticaria, Local reaction
Clinical narrative: 12 CM X 9.5 CM Wheal on the right deltoid.  No pain or fever.  No cellulitis.  Local reaction.
Sex: F
Vaccine: HPV4
Symptoms: Oedema peripheral, Pain in extremity
Clinical narrative: Information has been received from a consumer concerning her granddaughter (age not specified). The patient was vaccinated with GARDASIL approximately 2 years ago. The pt. suffered a sore arm with swelling. She became obnoxious, had a personality change, headaches and thyroid problems (onset date not provided). The pt. did not recover from these events. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to a patient of unknown age and sex who on 02-JUN-2010 and 08-NOV-2012, was vaccinated intramuscularly with the first and second dose, respectively, of GARDASIL (dose and lot Number Not reported). No other co-suspects were reported. No concomitant medications were reported. No adverse effect reported. Patient's outcome was unknown. Additional information has been requested.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Laboratory test, Musculoskeletal pain, Rash, Rash vesicular
Clinical narrative: This spontaneous report as received from a physician refers to an approximately 83 year-old female patient who is allergic to 12 medications. Approximately on 22-NOV-2012 (reported as 4 weeks ago), the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiry date, route and dose were not reported). No concomitant medications were reported. Approximately on 25-NOV-2012 (reported as 3 days later after vaccination) the patient experienced left shoulder pain and vesicular rash in that area. The patient was found to have C4 and C6 dermatome (hospitalization) and was diagnosed with shingles (hospitalization). Standard Laboratory tests were performed on an unspecified date and the results were not reported. The patient sought medical attention (was admitted to the hospital on an unspecified date in 2012) and was treated with VALTREX and after the course was done, the patient developed a rash on the hands and was given another course of VALTREX. On 13-DEC-2012 (reported as about 1 week ago), the patient recovered from all the reported events. The physician also reported that he had seen the patients 60 year old daughter who had has a history of chickenpox early in childhood had developed a vesicular rash on the right side of the face involving the nose 10 days ago. The patient's daughter had multiple unspecified antibiotic allergies, rheumatoid arthritis and was on steroids. The patient was treated with VALTREX and additional lesions were found on the left side of the face. There were multiple lesions that were small. The lesions were now crusted and the patient was being treated with VALTREX. Additional information has been requested.
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Axillary pain, Back pain, Blood pressure increased, Dizziness
Clinical narrative: Hypersensitivity to flu vaccine - joints, back and (R) armpit edema/pain malaise, dizziness, headache, elevated blood pressure.
Sex: F
Vaccine: FLU3
Symptoms: Headache, Hypersensitivity, Malaise, Oedema
Clinical narrative: Hypersensitivity to flu vaccine - joints, back and (R) armpit edema/pain malaise, dizziness, headache, elevated blood pressure.
Sex: U
Vaccine: MMRV, VARCEL
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. The patient received a dose of PROQUAD (Merck) (lot # H015643, exp 23-FEB-2014) that was exposed to refrigeration temperature for 168 hours; at the same time, the patient also received a dose of (Merck) VARIVAX (lot # H006952, exp 16-MAR-2014). The nurse stated, "Maybe the MM-R II component of the PROQUAD was still good, and the patient may not have to be revaccinated." This vaccination session occurred on 19-DEC-2012. It was unknown if the patient sought medical attention. No adverse effect has been observed or reported. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: 20 minutes after receiving flu vaccine employee developed hives on her neck & face. No chest pain no S.O.B. Took BENADRYL 25mg P.O in work. Took another 25mg 2 hours later at home. 4 hours later hives subsided. Employee's first flu shot.
Age: 1.95
Sex: M
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: Influenza vaccine administered 11/16/12. Parents report a day later child had a fever 102.8 degrees which would respond to TYLENOL. Fever lasted 24 hours. No other symptoms. Parents did not seek medical care.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: 2 hrs after receiving vaccine developed painful, raised (L) lymph node in axilla - no other symptoms.
Age: 1.09
Sex: M
Vaccine: DTAP, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Rash, Rubella, Varicella
Clinical narrative: Received MMR vaccine on 11-26-12; came to office on 12/6/12 with rash-diagnosed with chickenpox, patient & mother went to clinic on ? dare & diagnosed with Rubella.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Pruritus, Pyrexia, Rash, Urticaria
Clinical narrative: Fever, Skin Rash, Urticaria Pruritus & weakness. Diphenhydramine 25 mg PRN.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Productive cough, Throat irritation, Vomiting
Clinical narrative: Scratchy throat, Vomiting, Shortness of breath, Cough with copious mucus.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Hypoaesthesia, Hypokinesia, Movement disorder, Myalgia
Clinical narrative: 12/4/12 - Numbness tingling in hands, feet, arms, legs. Dizziness, feeling faint. 12/13/12 ~9PM - same as above - reported to ER. Said it was myalgia. 12/17/12 ~7AM - reported to ER - sched appt w/Neurology for 12/18 said was paresthesia/numbness. Saw neuro - sd doesn't act like GBS.  12/18/12 2PM - saw Neurology - Sched EMG for 12/28/12. ~7 PM returned to ER this time couldn't move arms/legs. Kept overnight seen by Neuro again. Will return 12/28/12 for EMG. 12/26/12 again with numbness tingling hard to control movement of arms. Possibly will return to ER.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Paraesthesia
Clinical narrative: 12/4/12 - Numbness tingling in hands, feet, arms, legs. Dizziness, feeling faint. 12/13/12 ~9PM - same as above - reported to ER. Said it was myalgia. 12/17/12 ~7AM - reported to ER - sched appt w/Neurology for 12/18 said was paresthesia/numbness. Saw neuro - sd doesn't act like GBS.  12/18/12 2PM - saw Neurology - Sched EMG for 12/28/12. ~7 PM returned to ER this time couldn't move arms/legs. Kept overnight seen by Neuro again. Will return 12/28/12 for EMG. 12/26/12 again with numbness tingling hard to control movement of arms. Possibly will return to ER.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to unknown number of patient of unknown age and gender. Approximately on an unknown date in 2012, the patients were vaccinated with a dose of GARDASIL (lot number 0420AE, other lot numbers were reported as H010436 and H010364, expiry date, dose and route were not reported) that had a temperature excursion of 26 Fahrenheit for 17.5 hours and unsupported. This was a cumulative time frame and may have been occurring since 26-NOV-2012. The patients would have been vaccinated with the unsupported GARDASIL as a result of temperature excursion. No concomitant medications were reported. This is one of the 2 reports received from the same reporter (MARRS- 1212USA007173). Additional information has been requested.
Age: 55.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Asthenia, Herpes zoster, Injected limb mobility decreased, Injection site pain, Pain
Clinical narrative: Pain in both deltoid muscles, no strength in arms, cannot lift arms more than a few inches before having excruciating pain. Four weeks to the day after the vaccinations I came down with shingles on my right leg (first time ever).  At nine weeks the pain and loss of strength have not improved. Pain is especially intense in the early morning and I'm unable to use my arms to get out of bed.
Age: 28.0
Sex: F
Vaccine: FLU3, HEPAB, IPV, TD
Symptoms: Urticaria
Clinical narrative: Following vaccination, patient developed hives.
Age: 60.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site vesicles
Clinical narrative: Blisters at the injection site. Triamcinolone.
Age: 19.0
Sex: F
Vaccine: PPV
Symptoms: Splenectomy
Clinical narrative: This spontaneous report as received from a consumer concerning to her 19 year old daughter who on an unknown date was vaccinated with PNEUMOVAX 23 injection (dose, frequency, route and lot number not provided). Medical history or drug reactions/allergies were not provided. Other co-suspects were not reported. Concomitant medications were not reported. The consumer reported that her daughter has had splenectomy (On an unknown date) when she was 19 years old and had been receiving PNEUMOVAX 23 every 5 years. No treatment information was reported. The patient's outcome due to splenectomy was unknown. The causality for the event of splenectomy was not provided. Upon internal review a splenectomy was considering a medically significant event. Additional information is not expected.
Age: 1.46
Sex: F
Vaccine: PNC13
Symptoms: Eczema asteatotic, Pyrexia, Vaccination site haematoma, Vaccination site swelling
Clinical narrative: PC vaccine -large area of bruising and swelling at area of vaccine. Dry eczema patch under eye, persisting low grade fever (99-102).
Age: 1.28
Sex: F
Vaccine: DTAPIPVHIB, MMR, PNC13
Symptoms: Face oedema, Parotitis, Swelling face, Tenderness
Clinical narrative: Child awoke 11/30/12 with edema to right side of face and jaw area. On exam in office area tender to touch and appear swollen. No redness, no fever dx: Parotiditis per mother no futher sx after 12/12/12. Required two dr visits.
Age: 26.0
Sex: F
Vaccine: FLUX
Symptoms: Blood glucose decreased, Chills, Decreased appetite, Dizziness, Fatigue
Clinical narrative: Nausea, anorexia; extreme fatigue; dizziness; pain under ears; chills; low blood pressure; blood sugar drops despite adequate glucose - duration: lasting over one week.
Age: 26.0
Sex: F
Vaccine: FLUX
Symptoms: Hypotension, Nausea, Pain
Clinical narrative: Nausea, anorexia; extreme fatigue; dizziness; pain under ears; chills; low blood pressure; blood sugar drops despite adequate glucose - duration: lasting over one week.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Disturbance in attention, Dizziness, Headache, Myalgia
Clinical narrative: Extreme headache, fever, chills, muscle pain lasted approximately 24-36 hours. Followed by neck pain, nausea, dizziness, blurry eyes and inability to concentrate. Primary care doctor thought it was a virus with vertigo, treated by Physical Therapist for vertigo, no improvemnt. Had MRI and sent for follow-up studies. On going at present.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Neck pain, Nuclear magnetic resonance imaging, Pyrexia, Vertigo
Clinical narrative: Extreme headache, fever, chills, muscle pain lasted approximately 24-36 hours. Followed by neck pain, nausea, dizziness, blurry eyes and inability to concentrate. Primary care doctor thought it was a virus with vertigo, treated by Physical Therapist for vertigo, no improvemnt. Had MRI and sent for follow-up studies. On going at present.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Vision blurred
Clinical narrative: Extreme headache, fever, chills, muscle pain lasted approximately 24-36 hours. Followed by neck pain, nausea, dizziness, blurry eyes and inability to concentrate. Primary care doctor thought it was a virus with vertigo, treated by Physical Therapist for vertigo, no improvemnt. Had MRI and sent for follow-up studies. On going at present.
Age: 0.76
Sex: M
Vaccine: FLU3
Symptoms: Malaise
Clinical narrative: Illness.
Age: 58.0
Sex: F
Vaccine: FLUX
Symptoms: Activities of daily living impaired, Insomnia, Limb injury, Muscular weakness, Pain in extremity
Clinical narrative: My arm has been horribly injured. I think they damaged a nerve and/or bone in my arm. My arm has had severe pain and weakness for more than a month now. I have pain at night in my arm that keeps me up. I cant do the normal things I could do with my arm before this vaccine. Please help me!
Age: 54.0
Sex: M
Vaccine: FLUX
Symptoms: Arthralgia, Asthenia, Cough, Gastrointestinal pain, Headache
Clinical narrative: Runny nose, sneezing, coughing, wheezing, headache, aching joints, intestinal pain, low energy.
Age: 54.0
Sex: M
Vaccine: FLUX
Symptoms: Rhinorrhoea, Sneezing, Wheezing
Clinical narrative: Runny nose, sneezing, coughing, wheezing, headache, aching joints, intestinal pain, low energy.
Age: 1.02
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Induration, Local reaction
Clinical narrative: Local reaction - erythema/induration developed 8d after vaccine.
Age: 10.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: (L) upper arm, red, hot, swollen 6cm x 5cm. Cool compresses and MOTRIN.
Age: 0.18
Sex: F
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Crying, Pyrexia
Clinical narrative: Excessive crying x 1 night after immunization; fever of 101-102 x 1 night.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Axillary pain, Injection site pain
Clinical narrative: On 12/24/12 patient reported that her arm hurts at the injection site as well as under her arm. She said she was going to see a Dr. On 12/26/12 I called her and she said she was better - no pain or discomfort.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Injection site erythema, Injection site swelling, Loss of consciousness
Clinical narrative: Redness and swelling at injection site. Has been dizzy and "passed out" approx. 6 times since receiving the vaccine.
Age: 81.0
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, Oedema peripheral, Vision blurred
Clinical narrative: Approx. 20 min. after getting vaccine, the pt. noticed swelling in (R) forearm. I then notified the RN. RN note indicates no pain reported, but long w/ swelling. Pt. complained of weakness and blurred vision.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Pain in extremity
Clinical narrative: Stabbing, knife like pain in left arm post vaccination. No redness or swelling noted. Pt states can't lift arm, still very painful. Had instant pain with injection, minimal improvement 16 days later. Pt declines follow up with physician to recheck arm.
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus, Rash
Clinical narrative: Rashes and itching on the trunk area.
Age: 89.0
Sex: F
Vaccine: UNK
Symptoms: Erythema, Oedema peripheral, Skin warm
Clinical narrative: Had pneumonia shot 9/20/12, then received another one 12/22/12. Reaction - left arm is red, hot, swollen (edematous).
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Flushing, Vaccination site pain
Clinical narrative: This spontaneous report as received from a physician refers to a 12 years old female patient with amoxicillin allergy and no pertinent medical history. The patient was vaccinated with the first dose of GARDASIL IM (Lot # not reported) on 19-JUL-2012, and received the second dose of GARDASIL IM (Lot # 0131AE, expiration date 26-OCT-2014). No other co-suspects were reported. Concomitant medications included CONCERTA, INTUNIV and ZANTAC. The physician reported that on 27-SEP-2012, the patient experienced felt dizzy, had a flushed face and stated that her arm hurt where she was vaccinated following the second dose of GARDASIL. The physician stated that patient was kept at the office and instructed to lie down and given fluids (juice). The patient's vital signs were stable while at the office (lying down). The patient stated that she felt fine after about an hour and a half and went home. The patient was called at home later on the same day and was reported to have recovered. There were no Lab diagnosis or studies performed. It was reported that the patient did not experience adverse events with the first vaccination of GARDASIL. The relatedness for felt dizzy, her arm hurt and had a flushed face was unknown for GARDASIL. Additional information has been requested.