chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 11.0
Sex: F
Vaccine: HEPA, TDAP
Symptoms: Abdominal pain, Blood calcium normal, Blood chloride normal, Blood creatinine normal, Blood glucose normal
Clinical narrative: About 2 hours after receiving Tdap and Hep A vaccines (4:30 pm) my daughter started to feel nauseous. Two hours later she started having bad abdominal pain and vomiting. She vomited about 6 times and her abdominal pain had gotten worse before I took her to the ER at about 9:15 pm.  She was given 1 dose of iv ondansetron, iv morphine, 30 cc of po Maalox and 1 liter of Normal Saline. An abominal ultrasound ruled out acute appendicitis and ovarian torsion while some debris was seen in the bladder. She had a urinalysis done that was negative. She never had a fever and that was documented at the ER and doctor's office earlier in the day. She experienced relief about 20 minutes after the iv morphine dose.  After ruling out other causes the ER assumed this was the beginning of a virus and sent us home with an RX for 4 doses of ondansetron (4mg po q6hr prn nausea) and warned us that she would probably could also have explosive diarrhea.  The next day she was able to eat the diet recommended by the hospital and she did not have any virus symptoms. She did have some abdominal pain later in the week only after drinking milk. That seems to have subsided. She has recovered from the event.  Considering the temporal relationship of the event and vaccine administration, and other causes ruled out, it's difficult to rule out an association between the vaccine administration and this event.
Age: 11.0
Sex: F
Vaccine: HEPA, TDAP
Symptoms: Blood potassium normal, Blood sodium normal, Blood urea normal, Carbon dioxide normal, Nausea
Clinical narrative: About 2 hours after receiving Tdap and Hep A vaccines (4:30 pm) my daughter started to feel nauseous. Two hours later she started having bad abdominal pain and vomiting. She vomited about 6 times and her abdominal pain had gotten worse before I took her to the ER at about 9:15 pm.  She was given 1 dose of iv ondansetron, iv morphine, 30 cc of po Maalox and 1 liter of Normal Saline. An abominal ultrasound ruled out acute appendicitis and ovarian torsion while some debris was seen in the bladder. She had a urinalysis done that was negative. She never had a fever and that was documented at the ER and doctor's office earlier in the day. She experienced relief about 20 minutes after the iv morphine dose.  After ruling out other causes the ER assumed this was the beginning of a virus and sent us home with an RX for 4 doses of ondansetron (4mg po q6hr prn nausea) and warned us that she would probably could also have explosive diarrhea.  The next day she was able to eat the diet recommended by the hospital and she did not have any virus symptoms. She did have some abdominal pain later in the week only after drinking milk. That seems to have subsided. She has recovered from the event.  Considering the temporal relationship of the event and vaccine administration, and other causes ruled out, it's difficult to rule out an association between the vaccine administration and this event.
Age: 11.0
Sex: F
Vaccine: HEPA, TDAP
Symptoms: Ultrasound abdomen abnormal, Urine analysis normal, Vomiting
Clinical narrative: About 2 hours after receiving Tdap and Hep A vaccines (4:30 pm) my daughter started to feel nauseous. Two hours later she started having bad abdominal pain and vomiting. She vomited about 6 times and her abdominal pain had gotten worse before I took her to the ER at about 9:15 pm.  She was given 1 dose of iv ondansetron, iv morphine, 30 cc of po Maalox and 1 liter of Normal Saline. An abominal ultrasound ruled out acute appendicitis and ovarian torsion while some debris was seen in the bladder. She had a urinalysis done that was negative. She never had a fever and that was documented at the ER and doctor's office earlier in the day. She experienced relief about 20 minutes after the iv morphine dose.  After ruling out other causes the ER assumed this was the beginning of a virus and sent us home with an RX for 4 doses of ondansetron (4mg po q6hr prn nausea) and warned us that she would probably could also have explosive diarrhea.  The next day she was able to eat the diet recommended by the hospital and she did not have any virus symptoms. She did have some abdominal pain later in the week only after drinking milk. That seems to have subsided. She has recovered from the event.  Considering the temporal relationship of the event and vaccine administration, and other causes ruled out, it's difficult to rule out an association between the vaccine administration and this event.
Age: 58.0
Sex: M
Vaccine: FLUX
Symptoms: Ear pain, VIIth nerve paralysis
Clinical narrative: Pain behind left ear and Bell's Palsy symptoms including partial paralysis of the face.  Anti-viral drugs administered as well as steroid shot.
Age: 62.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Injection site pain, Pain
Clinical narrative: "Ache" "sore" pain upper right arm upon "movement over head or lifting." Onset after vaccine administered on 10/10/13 per patient. Patient says Tylenol and heat has helped some. Pain continues to this date. (Info received from girlfriend.) Pain still off/on since Oct 2013.
Age: 57.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Injection site pain
Clinical narrative: "Ache" "sore" pain upper right arm upon movement over head or lifting". Onset after vaccine administered on 10/10/13 per patient. Patient says Tylenol and heat has helped some. Pain continues to this date. Patient says pain still "off/on" since Oct 2013.
Age: 11.0
Sex: M
Vaccine: HPV4
Symptoms: Butterfly rash, Rash erythematous
Clinical narrative: Bright red rash on cheeks (mallar rash) for 2 weeks. No other issues.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site bruising, Injection site erythema, Injection site pruritus, Injection site rash
Clinical narrative: Bruising and large, erythematous circular rash that was pruritic on left thigh around injection site of Varicella and Kinrix (Dtap/IPV) injections.
Age: 28.0
Sex: F
Vaccine: FLU3, TYP, YF
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Redness and some swelling and itching at site of injection on R arm.
Age: 40.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Accidental exposure to product, Eye irritation, Eye pruritus
Clinical narrative: Patient was seen with her child who was to receive the MMR vaccine.  During injection, the child struggled and the needle came out of the arm while it was being plunged.  The vaccine was inadvertently sprayed into mother's right eye. Eye was flushed with water and mother advised to follow up if any further symptoms.  Mother returned on 1/29/14 with symptoms of burning and itching on lateral aspect of eye.  Treated with Tobradex and advised to return in 1 week if no improvement.  Mother has appointment with optometrist on 2/5/14 for additional follow up.
Age: 40.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Accidental exposure to product, Exposure via direct contact, Eye irritation, Eye pruritus
Clinical narrative: Patient was seen with her child who was to receive the MMR vaccine.  During injection, the child struggled and the needle came out of the arm while it was being plunged.  The vaccine was inadvertently sprayed into mother's right eye. Eye was flushed with water and mother advised to follow up if any further symptoms.  Mother returned on 1/29/14 with symptoms of burning and itching on lateral aspect of eye.  Treated with Tobradex and advised to return in 1 week if no improvement.  Mother has appointment with optometrist on 2/5/14 for additional follow up.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site pruritus, Rash papular
Clinical narrative: Itching of the arm where the vaccine had been given and at 4:00 PM when I saw her she had a fine papular rash up and down the arm. No problems breathing or anything else.
Age: 0.12
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Abdominal pain lower, Abnormal faeces, Crying, Diarrhoea, Faeces discoloured
Clinical narrative: Lower abdominal pain, shrieking after eating. Diapers went from mustard, clay like consistency with waxy seeds to dark brown and moss green liquid that was foul smelling, explosive and progressively worse. Frequency went from every feeding to once every 1.5 days.
Age: 0.12
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Feeding disorder of infancy or early childhood
Clinical narrative: Lower abdominal pain, shrieking after eating. Diapers went from mustard, clay like consistency with waxy seeds to dark brown and moss green liquid that was foul smelling, explosive and progressively worse. Frequency went from every feeding to once every 1.5 days.
Age: 42.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Altered state of consciousness, Flushing, Somnolence
Clinical narrative: Within about 10 seconds after administering vacine, patient seemed very sleepy.  I talked to him through the entire incident which lasted approximately 5 minutes.  Patient did not lose consciousness.  He stated that he felt flushing all over his body, but did not feel light headed or nauseous.  The flushing was the only symptom reported, although the patient appeared to be close to losing consciousness.
Age: 42.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Altered state of consciousness, Flushing, Immediate post-injection reaction, Somnolence
Clinical narrative: Within about 10 seconds after administering vacine, patient seemed very sleepy.  I talked to him through the entire incident which lasted approximately 5 minutes.  Patient did not lose consciousness.  He stated that he felt flushing all over his body, but did not feel light headed or nauseous.  The flushing was the only symptom reported, although the patient appeared to be close to losing consciousness.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Cough, Nasal congestion, Rhinorrhoea
Clinical narrative: Nasal congestion, runny nose, cough.
Age: 0.56
Sex: F
Vaccine: DTAPHEPBIP, FLU3, PNC13
Symptoms: Blood culture, C-reactive protein increased, Erythema, Injection site cellulitis, Leukocytosis
Clinical narrative: Mother states that there was redness, swelling, and fever.
Age: 0.56
Sex: F
Vaccine: DTAPHEPBIP, FLU3, PNC13
Symptoms: Pyrexia, Red blood cell sedimentation rate increased, Swelling
Clinical narrative: Mother states that there was redness, swelling, and fever.
Age: 19.0
Sex: F
Vaccine: ANTH, FLUC3, SMALL, TYP, ANTH, FLU3, SMALL, TYP
Symptoms: Exposure during pregnancy, Pregnancy test negative
Clinical narrative: Patient recieved SPX vaccination on 01/08/2014 after a negative pregnancy test. On 02/03/2014 patient found out that she was pregnant which was confirmed by another pregnancy test.
Age: 19.0
Sex: F
Vaccine: ANTH, FLUC3, SMALL, TYP, ANTH, FLU3, SMALL, TYP
Symptoms: Exposure during pregnancy, No adverse event, Pregnancy test positive
Clinical narrative: Patient recieved SPX vaccination on 01/08/2014 after a negative pregnancy test. On 02/03/2014 patient found out that she was pregnant which was confirmed by another pregnancy test.
Age: 0.51
Sex: M
Vaccine: DTAP, HEP, IPV
Symptoms: Electroencephalogram, Infantile spasms
Clinical narrative: Onset of infantile spasms.
Age: 18.0
Sex: M
Vaccine: FLUC3, FLUC3
Symptoms: Syncope
Clinical narrative: Pt experienced syncope.
Age: 51.0
Sex: F
Vaccine: TD
Symptoms: Back pain, Injection site pain, Injection site reaction, Joint range of motion decreased, Muscle strain
Clinical narrative: Severe tightness, stiffness, pain, tenderness to upper right arm and radiating to back and neck.  Unable to get range of motion to side with arm during am & pm, muscle strain going on to three weeks after injection.  Symptons worse in pm and am.
Age: 51.0
Sex: F
Vaccine: TD
Symptoms: Muscle tightness, Musculoskeletal stiffness, Neck pain, Skin tightness, Tenderness
Clinical narrative: Severe tightness, stiffness, pain, tenderness to upper right arm and radiating to back and neck.  Unable to get range of motion to side with arm during am & pm, muscle strain going on to three weeks after injection.  Symptons worse in pm and am.
Age: 23.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Nausea, Pain, Pyrexia, Vomiting
Clinical narrative: Nausea vomiting body aches fever of 104 degrees F.
Age: 33.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Anxiety, Nervousness, Pallor, Syncope
Clinical narrative: Syncope. Pt was pale, anxious, and nervous. Pt fainted 5 mins after flu shot. Pt regain conscious within 5-10 sec and was fully aware of her surroundings. Pt reported that she was not injured and tends to faint when she get nervous. Pt stay in a resting position for approximately 20-25 mins before leaving on her own power.
Age: 33.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Anxiety, Loss of consciousness, Nervousness, Pallor, Syncope
Clinical narrative: Syncope. Pt was pale, anxious, and nervous. Pt fainted 5 mins after flu shot. Pt regain conscious within 5-10 sec and was fully aware of her surroundings. Pt reported that she was not injured and tends to faint when she get nervous. Pt stay in a resting position for approximately 20-25 mins before leaving on her own power.
Age: 25.0
Sex: F
Vaccine: VARCEL
Symptoms: Asthenia, Diarrhoea, Feeling cold, Headache, Injection site rash
Clinical narrative: Vomiting and diarrhea for 8 hours. Weakness and headache with feeling of cold and feverish until about 3 pm. (No one else in family got sick).  Also got a rash around the injection site starting on 02/03/2014.
Age: 25.0
Sex: F
Vaccine: VARCEL
Symptoms: Pyrexia, Vomiting
Clinical narrative: Vomiting and diarrhea for 8 hours. Weakness and headache with feeling of cold and feverish until about 3 pm. (No one else in family got sick).  Also got a rash around the injection site starting on 02/03/2014.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Rash, Rash erythematous, Rash pruritic, Skin warm
Clinical narrative: 2 inch red, warm, itchy, painful rash like spot grew to 5 inches in diameter, started 4 AM Saturday 2/1/14. Treated with Cephalexin from CC. Rash went back down to 2 inches.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, VIIth nerve paralysis
Clinical narrative: Pt called 1/16/19 stating she woke up 1/15/14 with (R) sided numbness in face and drooping of face. Immediately sent to urgent care clinic. Pt given steroid shot and PO steroids.
Sex: M
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: Fever low grade subjective x 2d.
Sex: U
Vaccine: FLU3
Symptoms: Adverse reaction
Clinical narrative: None stated.
Sex: U
Vaccine: FLU3
Symptoms: Otitis media
Clinical narrative: (B) otitis media 1/28/2014. Given AUGMENTIN.
Age: 2.0
Sex: U
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Muscle spasms, Pain
Clinical narrative: Pt called 1/31 and said left side numb and in pain, went to MD and he said muscle spasm ok and call if gets worse.
Sex: U
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: Low grade fever x 2d.
Sex: M
Vaccine: VARCEL
Symptoms: Adverse reaction
Clinical narrative: This spontaneous report was received from a male patient's mother refers to her son of unknown age. On an unknown date the patient was vaccinated with VARIVAX (Merck) (dose, route and lot # not reported). The reporter stated that the patient developed an "unspecified adverse reaction" after receiving VARIVAX (Merck) (dosage unknown). The reporter then stated, my son received VARIVAX (Merck) years ago (specific dates and dosage unknown) and developed an unspecified adverse reaction then as well. It was unknown if the patient sought medical attention. The outcome of the events was unknown. Additional information is not expected.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker (C.M.A.) refers to a patient of unknown age. On 16-DEC-2010, the patient was vaccinated with first dose of GARDASIL (dose, route, injection site, lot# not provided). On 30-JAN-2014 the patient came to the office late to vaccinated with the second dose of GARDASIL (dose, route, injection site, lot# not provided). No adverse symptoms reported. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a 17 year old female patient. Pertinent medical history, drug allergies or reactions were not reported. On 30-JAN-2014, the patient was vaccinated with PROQUAD (Merck), 0.5 ml, subcutaneous (lot # reported as "J007206", expiry date: 20-DEC-2014) for prevention of measles, mumps, rubella and varicella. the nurse stated that the patient received PROQUAD (Merck) in place of MMR II and VARIVAX (Merck). No adverse event reported. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Incomplete course of vaccination, No adverse event
Clinical narrative: Information has been received from the mother of the female patient (age not reported) who on an unknown dates was vaccinated with dose 1 and 2 of GARDASIL (routes not reported). It was reported that the patient did not receive the 3rd dose of GARDASIL. The patient did not experience any adverse events. Additional information is not expected.
Age: 1.04
Sex: M
Vaccine: HEPA, HIBV, PNC13
Symptoms: Condition aggravated, Petechiae, Platelet count decreased, Pyrexia, Thrombocytopenia
Clinical narrative: Petechia 12/20, thrombocytopenia 12/21 (platelets 7K). Fever 12/20-12/21. Platelets 12K on 12/23, back to normal on 12/27 (314K).
Age: 31.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Movement disorder, Myalgia, Pain
Clinical narrative: Per patient, she developed severe arm and shoulder aches/pains almost immediately after receiving Tdap shot.  Per patient, she then went to a local Urgent Care center, and also saw a neurologist, who diagnosed her with brachial neuritis, from an adverse reaction to the Tdap shot.
Age: 31.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Musculoskeletal pain, Pain in extremity, Radiculitis brachial, Vaccination complication
Clinical narrative: Per patient, she developed severe arm and shoulder aches/pains almost immediately after receiving Tdap shot.  Per patient, she then went to a local Urgent Care center, and also saw a neurologist, who diagnosed her with brachial neuritis, from an adverse reaction to the Tdap shot.
Age: 76.0
Sex: U
Vaccine: FLUX, PPV, FLUX, PPV
Symptoms: Arthralgia, Back pain, Pain in extremity
Clinical narrative: Pain in low back and hips - probably 5 to 8 min. Pain went away without any treatment.
Age: 76.0
Sex: U
Vaccine: FLUX, PPV, FLUX, PPV
Symptoms: Arthralgia, Back pain
Clinical narrative: Pain in low back and hips - probably 5 to 8 min. Pain went away without any treatment.
Age: 0.37
Sex: M
Vaccine: HIBV, PNC13, HIBV, PNC13
Symptoms: Body temperature increased, Dyskinesia, Eyelid oedema, Inflammation, Lethargy
Clinical narrative: Mother called about 1 1/2 hours after shots to report that baby "passed out asleep and did not wake up when she moved him to his crib". He was crying and awake when I spoke to her. Denies fever, color and breathing and muscle tone normal for baby, skin warm and dry to touch. To give baby acetaminophen and check back. 1 hour later mother reported medication helped. Talked with mother next morning at 11 AM: reported fussy all night, temp this morning of 101.8 rectally, green stool and he jerked himself awake twice and cry. She called HCP office: she was told to continue acetaminophen and if still concerned, could see ER or come to clinic to see Dr. at morning clinic. Reinforced these recommendations, re-education done on anticipated reactions. 012714-012814 Unable to contact via phone with many attempts. 012914 made visit: Mother reported no fever after 24 hours, did not take him to clinic. Baby doing well today. 11 AM.
Age: 0.37
Sex: M
Vaccine: HIBV, PNC13, HIBV, PNC13
Symptoms: Loss of consciousness, Pallor, Rash erythematous, Respiratory rate decreased, Screaming
Clinical narrative: Mother called about 1 1/2 hours after shots to report that baby "passed out asleep and did not wake up when she moved him to his crib". He was crying and awake when I spoke to her. Denies fever, color and breathing and muscle tone normal for baby, skin warm and dry to touch. To give baby acetaminophen and check back. 1 hour later mother reported medication helped. Talked with mother next morning at 11 AM: reported fussy all night, temp this morning of 101.8 rectally, green stool and he jerked himself awake twice and cry. She called HCP office: she was told to continue acetaminophen and if still concerned, could see ER or come to clinic to see Dr. at morning clinic. Reinforced these recommendations, re-education done on anticipated reactions. 012714-012814 Unable to contact via phone with many attempts. 012914 made visit: Mother reported no fever after 24 hours, did not take him to clinic. Baby doing well today. 11 AM.
Age: 0.37
Sex: M
Vaccine: HIBV, PNC13, HIBV, PNC13
Symptoms: Somnolence, Tension, Unresponsive to stimuli
Clinical narrative: Mother called about 1 1/2 hours after shots to report that baby "passed out asleep and did not wake up when she moved him to his crib". He was crying and awake when I spoke to her. Denies fever, color and breathing and muscle tone normal for baby, skin warm and dry to touch. To give baby acetaminophen and check back. 1 hour later mother reported medication helped. Talked with mother next morning at 11 AM: reported fussy all night, temp this morning of 101.8 rectally, green stool and he jerked himself awake twice and cry. She called HCP office: she was told to continue acetaminophen and if still concerned, could see ER or come to clinic to see Dr. at morning clinic. Reinforced these recommendations, re-education done on anticipated reactions. 012714-012814 Unable to contact via phone with many attempts. 012914 made visit: Mother reported no fever after 24 hours, did not take him to clinic. Baby doing well today. 11 AM.
Age: 0.37
Sex: M
Vaccine: HIBV, PNC13, HIBV, PNC13
Symptoms: Body temperature increased, Crying, Dry skin, Dyskinesia, Faeces discoloured
Clinical narrative: Mother called about 1 1/2 hours after shots to report that baby "passed out asleep and did not wake up when she moved him to his crib". He was crying and awake when I spoke to her. Denies fever, color and breathing and muscle tone normal for baby, skin warm and dry to touch. To give baby acetaminophen and check back. 1 hour later mother reported medication helped. Talked with mother next morning at 11 AM: reported fussy all night, temp this morning of 101.8 rectally, green stool and he jerked himself awake twice and cry. She called HCP office: she was told to continue acetaminophen and if still concerned, could see ER or come to clinic to see Dr. at morning clinic. Reinforced these recommendations, re-education done on anticipated reactions. 012714-012814 Unable to contact via phone with many attempts. 012914 made visit: Mother reported no fever after 24 hours, did not take him to clinic. Baby doing well today. 11 AM.
Age: 0.37
Sex: M
Vaccine: HIBV, PNC13, HIBV, PNC13
Symptoms: Irritability, Loss of consciousness, Skin warm, Somnolence
Clinical narrative: Mother called about 1 1/2 hours after shots to report that baby "passed out asleep and did not wake up when she moved him to his crib". He was crying and awake when I spoke to her. Denies fever, color and breathing and muscle tone normal for baby, skin warm and dry to touch. To give baby acetaminophen and check back. 1 hour later mother reported medication helped. Talked with mother next morning at 11 AM: reported fussy all night, temp this morning of 101.8 rectally, green stool and he jerked himself awake twice and cry. She called HCP office: she was told to continue acetaminophen and if still concerned, could see ER or come to clinic to see Dr. at morning clinic. Reinforced these recommendations, re-education done on anticipated reactions. 012714-012814 Unable to contact via phone with many attempts. 012914 made visit: Mother reported no fever after 24 hours, did not take him to clinic. Baby doing well today. 11 AM.
Age: 37.0
Sex: M
Vaccine: FLU3, HEP, HEPA, FLUX, HEP, HEPA
Symptoms: Hepatitis A antibody positive
Clinical narrative: This medically confirmed report (initial receipt 21-Jan-2014) concerns a 37 year old male patient who had a medical history of asthma. The patient had no antibodies to hepatitis A. On the 19-Nov-2013, the patient received VAQTA (batch number not provided). On the 04-Dec-2013, the patient received a influenza (manufacturer and batch number not reported), VAQTA (batch number not reported) and RECOMBIVAX (batch number not reported). On an unspecified date, the patient returned to this physician requesting a test for sexually transmitted diseases. A test for IgM hepatitis A antibodies were erroneously drawn and the results came back as positive. Outcome was reported as not recovered.
Age: 56.0
Sex: M
Vaccine: PPV, TDAP, HEPAB, PPV, TDAP
Symptoms: Cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: Swelling in (L) arm and elbow 24 hours after vac given. BACTRIM DS 1 PO BID x 10 days. TYLENOL 325 mg 2 PO BID x 7 days.
Age: 56.0
Sex: M
Vaccine: PPV, TDAP, HEPAB, PPV, TDAP
Symptoms: Injection site swelling
Clinical narrative: Swelling in (L) arm and elbow 24 hours after vac given. BACTRIM DS 1 PO BID x 10 days. TYLENOL 325 mg 2 PO BID x 7 days.
Age: 52.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Swelling in (L) arm and elbow where shot was given 24 hrs after. Tx: I/M 25 mg BENADRYL, BACTRIM DS PO BID x 10 days #20, MEDROL dose pack, observe for 2 hrs.
Age: 52.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Injection site swelling
Clinical narrative: Swelling in (L) arm and elbow where shot was given 24 hrs after. Tx: I/M 25 mg BENADRYL, BACTRIM DS PO BID x 10 days #20, MEDROL dose pack, observe for 2 hrs.
Age: 0.33
Sex: M
Vaccine: PNC
Symptoms: Electroencephalogram abnormal, Infantile spasms, Nuclear magnetic resonance imaging brain normal, Regressive behaviour
Clinical narrative: New onset infantile spasms with regression and West syndrome. Admitted for 3 days. Now treated with ACTH (Acthar). Second baby was admitted to MC on 1/27/2013 with symptom onset 1/24/2013. Dx also infantile spasm and West syndrome. Also treated with ACTH at this time.
Age: 39.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Guillain-Barre syndrome, Headache, Immunoglobulin therapy
Clinical narrative: Initial reaction was severe headaches which persisted for about two months.  I was also diagnosed with Guillain-Barre in Nov.  I was treated with high dose steroids and IVFG for.
Age: 44.0
Sex: F
Vaccine: MMR
Symptoms: Influenza like illness, Pain
Clinical narrative: BODY PAIN, FLU LIKE SYMPTOMS.
Age: 41.0
Sex: F
Vaccine: MNQ
Symptoms: Chills, Pain, Spinal pain
Clinical narrative: Pt called and had spine pain, chills and body pain after shot called day after Fri 1/29 and feeling better and called Mon 2/3 and feeling good.
Age: 61.0
Sex: F
Vaccine: FLUC3
Symptoms: Injection site erythema, Injection site swelling, Paraesthesia
Clinical narrative: Patient's arm red and swollen at injection site. Complained of tingling sensation throughout the arm.
Age: 15.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site pain, Local swelling, Skin warm
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a 15 year old female patient with no pertinent medical history or drug reactions/allergies. On 20-JAN-2014 the patient was vaccinated with a dose of PNEUMOVAX 23 (lot # J009827, expiration date 10-AUG-2014, 0.5 ml, intramuscular in the left arm) for history of hereditary spherocytosis. There was no concomitant medication. On 20-JAN-2014, the patient's left arm swelled up, it was really red, hot to the touch, and pain from the left shoulder to elbow. There was no treatment given for the patient. No lab diagnostics studies performed. The patient sought medical attention via visiting the office. The outcome of the events was unknown. This is one of the two reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR, MMRV, VARCEL
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from registered nurse refers to another nurse's grandchild of unknown age and gender who lives in another state. On an unknown date, previously patient was administered MMR II and VARIVAX (Merck) (dose number, dose unit, lot # and expiry date, route unknown) separately. On 27-DEC-2013 the patient was vaccinated with expired dose of PROQUAD (Merck) first dose (dose unit, lot # and expiry date, route unknown) for prophylactic vaccination by an unspecified provider in another state. Concomitant therapies included MMR II and VARIVAX (Merck). It was reported that the dose of PROQUAD (Merck) was the first dose of PROQUAD (Merck), but not the first dose of MMR II and VARIVAX (Merck). The nurse asked for follow-up for a safety report. No adverse event reported. The outcome of expired dose of PROQUAD was administered and no adverse event was unknown. No other information to report. Additional information has been requested.
Age: 74.0
Sex: M
Vaccine: FLUX
Symptoms: Alveolar lung disease, Antineutrophil cytoplasmic antibody negative, Aspergillus test negative, Atelectasis, Blood immunoglobulin E increased
Clinical narrative: This medically confirmed literature report (initial receipt 28-Jan-2014) concerns a 74 year old male who had a medical history of asthma and allergic rhinitis. He was a non-smoker and denied recent travel, sick contacts, pet exposure, and inhalation of chemicals, tobacco or commencing new medications. On an unspecified date, the patient received influenza vaccine (manufacturer and batch number not provided). On an unspecified date, one week after the vaccination he experienced malaise, low grade fever, a non-productive cough and shortness of breath. After a three week history of these symptoms, he presented for a medical examination. On exam, the patient was in no distress. A pulse oximetry measured 95% on room air. Auscultation revealed fine crepitations in lung bases bilaterally. A laboratory exam showed leukocytosis (30.6k/uL) with 71% eosinophils. A chest radiography showed slight atelectasis and effusion at the right lung base and high-resolution chest computer tomography showed bilateral lower lobe airspace disease with ground glass opacities and septal thickening, compatible with eosinophilic pneumonia. Other testing showed an increase in IgE (918IU/mL). Testing for Aspergillus-specific IgE, p-ANCA, c-ANCA and sputum culture were negative. Treatment included oral prednisolone, which resulted in improvement of respiratory symptoms, radiographic appearance and resolution of peripheral eosinophilia. A spirogram, done two weeks after initiation of steroids was normal. Outcome was reported as recovering. Reporter comments: The authors reported that as the patient had no clearly identifiable triggers, administration of influenza vaccine may have triggered eosinophilic pneumonitis.
Age: 74.0
Sex: M
Vaccine: FLUX
Symptoms: Chest X-ray abnormal, Computerised tomogram thorax abnormal, Cough, Culture negative, Dyspnoea
Clinical narrative: This medically confirmed literature report (initial receipt 28-Jan-2014) concerns a 74 year old male who had a medical history of asthma and allergic rhinitis. He was a non-smoker and denied recent travel, sick contacts, pet exposure, and inhalation of chemicals, tobacco or commencing new medications. On an unspecified date, the patient received influenza vaccine (manufacturer and batch number not provided). On an unspecified date, one week after the vaccination he experienced malaise, low grade fever, a non-productive cough and shortness of breath. After a three week history of these symptoms, he presented for a medical examination. On exam, the patient was in no distress. A pulse oximetry measured 95% on room air. Auscultation revealed fine crepitations in lung bases bilaterally. A laboratory exam showed leukocytosis (30.6k/uL) with 71% eosinophils. A chest radiography showed slight atelectasis and effusion at the right lung base and high-resolution chest computer tomography showed bilateral lower lobe airspace disease with ground glass opacities and septal thickening, compatible with eosinophilic pneumonia. Other testing showed an increase in IgE (918IU/mL). Testing for Aspergillus-specific IgE, p-ANCA, c-ANCA and sputum culture were negative. Treatment included oral prednisolone, which resulted in improvement of respiratory symptoms, radiographic appearance and resolution of peripheral eosinophilia. A spirogram, done two weeks after initiation of steroids was normal. Outcome was reported as recovering. Reporter comments: The authors reported that as the patient had no clearly identifiable triggers, administration of influenza vaccine may have triggered eosinophilic pneumonitis.
Age: 74.0
Sex: M
Vaccine: FLUX
Symptoms: Eosinophil percentage increased, Eosinophilic pneumonia, Leukocytosis, Malaise, Pleural effusion
Clinical narrative: This medically confirmed literature report (initial receipt 28-Jan-2014) concerns a 74 year old male who had a medical history of asthma and allergic rhinitis. He was a non-smoker and denied recent travel, sick contacts, pet exposure, and inhalation of chemicals, tobacco or commencing new medications. On an unspecified date, the patient received influenza vaccine (manufacturer and batch number not provided). On an unspecified date, one week after the vaccination he experienced malaise, low grade fever, a non-productive cough and shortness of breath. After a three week history of these symptoms, he presented for a medical examination. On exam, the patient was in no distress. A pulse oximetry measured 95% on room air. Auscultation revealed fine crepitations in lung bases bilaterally. A laboratory exam showed leukocytosis (30.6k/uL) with 71% eosinophils. A chest radiography showed slight atelectasis and effusion at the right lung base and high-resolution chest computer tomography showed bilateral lower lobe airspace disease with ground glass opacities and septal thickening, compatible with eosinophilic pneumonia. Other testing showed an increase in IgE (918IU/mL). Testing for Aspergillus-specific IgE, p-ANCA, c-ANCA and sputum culture were negative. Treatment included oral prednisolone, which resulted in improvement of respiratory symptoms, radiographic appearance and resolution of peripheral eosinophilia. A spirogram, done two weeks after initiation of steroids was normal. Outcome was reported as recovering. Reporter comments: The authors reported that as the patient had no clearly identifiable triggers, administration of influenza vaccine may have triggered eosinophilic pneumonitis.
Age: 74.0
Sex: M
Vaccine: FLUX
Symptoms: Pleural fibrosis, Pyrexia, Rales, Sputum culture, Total lung capacity normal
Clinical narrative: This medically confirmed literature report (initial receipt 28-Jan-2014) concerns a 74 year old male who had a medical history of asthma and allergic rhinitis. He was a non-smoker and denied recent travel, sick contacts, pet exposure, and inhalation of chemicals, tobacco or commencing new medications. On an unspecified date, the patient received influenza vaccine (manufacturer and batch number not provided). On an unspecified date, one week after the vaccination he experienced malaise, low grade fever, a non-productive cough and shortness of breath. After a three week history of these symptoms, he presented for a medical examination. On exam, the patient was in no distress. A pulse oximetry measured 95% on room air. Auscultation revealed fine crepitations in lung bases bilaterally. A laboratory exam showed leukocytosis (30.6k/uL) with 71% eosinophils. A chest radiography showed slight atelectasis and effusion at the right lung base and high-resolution chest computer tomography showed bilateral lower lobe airspace disease with ground glass opacities and septal thickening, compatible with eosinophilic pneumonia. Other testing showed an increase in IgE (918IU/mL). Testing for Aspergillus-specific IgE, p-ANCA, c-ANCA and sputum culture were negative. Treatment included oral prednisolone, which resulted in improvement of respiratory symptoms, radiographic appearance and resolution of peripheral eosinophilia. A spirogram, done two weeks after initiation of steroids was normal. Outcome was reported as recovering. Reporter comments: The authors reported that as the patient had no clearly identifiable triggers, administration of influenza vaccine may have triggered eosinophilic pneumonitis.
Age: 74.0
Sex: M
Vaccine: FLUX
Symptoms: White blood cell count increased
Clinical narrative: This medically confirmed literature report (initial receipt 28-Jan-2014) concerns a 74 year old male who had a medical history of asthma and allergic rhinitis. He was a non-smoker and denied recent travel, sick contacts, pet exposure, and inhalation of chemicals, tobacco or commencing new medications. On an unspecified date, the patient received influenza vaccine (manufacturer and batch number not provided). On an unspecified date, one week after the vaccination he experienced malaise, low grade fever, a non-productive cough and shortness of breath. After a three week history of these symptoms, he presented for a medical examination. On exam, the patient was in no distress. A pulse oximetry measured 95% on room air. Auscultation revealed fine crepitations in lung bases bilaterally. A laboratory exam showed leukocytosis (30.6k/uL) with 71% eosinophils. A chest radiography showed slight atelectasis and effusion at the right lung base and high-resolution chest computer tomography showed bilateral lower lobe airspace disease with ground glass opacities and septal thickening, compatible with eosinophilic pneumonia. Other testing showed an increase in IgE (918IU/mL). Testing for Aspergillus-specific IgE, p-ANCA, c-ANCA and sputum culture were negative. Treatment included oral prednisolone, which resulted in improvement of respiratory symptoms, radiographic appearance and resolution of peripheral eosinophilia. A spirogram, done two weeks after initiation of steroids was normal. Outcome was reported as recovering. Reporter comments: The authors reported that as the patient had no clearly identifiable triggers, administration of influenza vaccine may have triggered eosinophilic pneumonitis.
Sex: U
Vaccine: VARZOS
Symptoms: Condition aggravated, Spondylitis
Clinical narrative: This spontaneous report was received from a healthcare worker via physician referring to a patient of unknown age (demographics unspecified). On an unknown date the patient started therapy with prednisone (manufacturer unknown)[lot # not reported](5 mg, QD)(route unspecified) for treatment of spondylosing arthritis. Other suspect therapies included ZOSTAVAX [lot # not reported](dose and route unspecified) administered on 28-JAN-2014. On an unknown date in January 2014 it was reported that prednisone (manufacturer unknown) was not controlling patient's spondylosing arthritis and there was no adverse event reported. The physician reported that the patient's spondylosing arthritis was getting worse while on prednisone (manufacturer unknown). The action taken of the event with the suspect drug prednisone (manufacturer unknown) was unknown. The action taken for ZOSTAVAX was not applicable. There was no PQC reported. The outcome of the event, prednisone not controlling patient's spondylosing arthritis was reported as not recovered/not resolved. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. No medical history or concurrent conditions were reported. On 09-JAN-2014 the patient was vaccinated with ZOSTAVAX lot # J011882. It was reported that the patient was administered ZOSTAVAX that may have gone through an unsupported temperature excursion due to delayed shipping from 13-DEC-2013 to 17-DEC-2013. No adverse effects were reported and no further information was provided. This is one of a total of two reports form the same source document. Additional information has been requested.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site cellulitis, Injection site discomfort, Injection site erythema, Injection site inflammation, Injection site pain
Clinical narrative: This spontaneous report as received from a nurse, refers to a 76 year old female patient. The patient had drug reactions/allergies for penicillin, vancomycin, ferrous sulfate and sulfa drugs. The reporter stated that an unspecified nurse in the medical office had administered ZOSTAVAX (0.65 ml, in the arm). On 21-OCT-2013 and the patient experienced an adverse event. The ZOSTAVAX was administered on the back of the arm above the elbow into a large amount of fatty tissue. On 23-OCT-2013 the patient returned to the medical office and complained of a large bump at the site of injection. The injection site was red and inflamed and the patient was experiencing pain. Patient was treated for the redness, inflammation and swelling with an unspecified medication on an unspecified date, as the unspecified physician was concerned that it was cellulitis. As of today, 09-JAN-2014, the patient still had pain and discomfort at the site of injection but was no longer experiencing redness, swelling or inflammation. The outcome of the events was not recovered. The relatedness between ZOSTAVAX and events was not reported. Additional information has been requested.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling
Clinical narrative: This spontaneous report as received from a nurse, refers to a 76 year old female patient. The patient had drug reactions/allergies for penicillin, vancomycin, ferrous sulfate and sulfa drugs. The reporter stated that an unspecified nurse in the medical office had administered ZOSTAVAX (0.65 ml, in the arm). On 21-OCT-2013 and the patient experienced an adverse event. The ZOSTAVAX was administered on the back of the arm above the elbow into a large amount of fatty tissue. On 23-OCT-2013 the patient returned to the medical office and complained of a large bump at the site of injection. The injection site was red and inflamed and the patient was experiencing pain. Patient was treated for the redness, inflammation and swelling with an unspecified medication on an unspecified date, as the unspecified physician was concerned that it was cellulitis. As of today, 09-JAN-2014, the patient still had pain and discomfort at the site of injection but was no longer experiencing redness, swelling or inflammation. The outcome of the events was not recovered. The relatedness between ZOSTAVAX and events was not reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Staphylococcal infection
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative refers to a unspecified amount of patients of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date the patients were vaccinated with ZOSTAVAX. Dose, route and lot number were not reported. No co-suspect and concomitant therapies were reported. The physician reported that unspecified amount of patients developed an unspecified staphylococcus infection at an unspecified time after receiving ZOSTAVAX. He reported that "some" of the unspecified patients sought out medical attention an unspecified way at unspecified time. He also reported hospitalization for an unspecified amount of patients due to the unspecified staphylococcus infection at an unspecified time. At the time of this report the outcome of unspecified staphylococcus infection was unknown. The causality was not reported. 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 Licensed Practical Nurse refers to a patient of unknown age. On 30-JAN-2014 the patient was vaccinated with an expired dose of M-M-R II (lot# 0232AE, exp date 26-JAN-2014, dose, route and indication not reported). The product did not have any previous temperature excursions. No adverse symptoms reported. 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 nurse refers to a patient of unknown age and gender. On 20-DEC-2013 the patient received first dose of expired MMR II (HSA, lot # 671686/1874aA exp. date: 30-NOV-2013, dose, strength, site and route of administration not reported) which has expired for vaccination. No adverse event reported. This is one of two reports from the same reporter. Linked case MARRS # 1401USA003889. Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Immediate post-injection reaction, Pruritus
Clinical narrative: This spontaneous report as received from a pharmacy student refers to an unspecified number of patients. On unknown dates the patient were vaccinated with ZOSTAVAX, subcutaneously. All patients were vaccinated at the reporter's pharmacy. The lot number was reported as J011549 (confirmed valid) with expiry date 19-DEC-2014, dose number and anatomical location were not reported. The reporter stated that all patients that were vaccinated with lot number J011549 ZOSTAVAX at the reporter's pharmacy experienced itching immediately after injection. The itching was often accompanied by a small amount of redness. The itching resolved within a few hours, the outcome of itching immediately after injection was reported as recovered/resolved. The outcome of small amount of redness is unknown. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Nurse Practitioner refers to a patient of unknown age and gender. On 14-JAN-2014 the patient was vaccinated with GARDASIL (dose and route not reported, lot # J009098, expiration date 04-DEC-2015). There was no concomitant medication reported. The nurse reported that the patient received the improperly stored, GARDASIL on 14-JAN-2014. No adverse effects reported. This is one of two reports from the same source. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from an office manager refers to a patient of unknown age and gender. The reporter stated that a patient was administered an expired dose of VARIVAX (Merck) (0.5 ml, lot # 1881AA, exp. date: 30-NOV-2013) on 13-DEC-2013. No adverse effects were reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Rash erythematous
Clinical narrative: This spontaneous report as received from a pharmacist via company representative refers to two female patient of unknown age. On an unknown date of 2013 the patient was vaccinated with ZOSTAVAX vial (dose number, dose unit, lot # and expiry date, route unknown) for prevention of shingles. Approximately on an unknown date in August 2013 in the last six months, two unspecified female patients returned with a red rash around injection site after receiving ZOSTAVAX and no treatment was provided. It was reported that two patients saw the pharmacist and VZVIP was not faxed, as fax number was not available for pharmacist. The outcome of red rash around injection site was unknown. No further information was provided. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a patient of unknown age and gender. On 09-AUG-2012 the patient was vaccinated with the first dose of GARDASIL (route, lot number and expiration date not reported). There was no concomitant medication reported. Nurse reported that on 01-AUG-2013 the patient was vaccinated with the second dose of GARDASIL (route, lot number and expiration date not reported) and on 29-OCT-2013 the patient was vaccinated with the third dose of GARDASIL (route, lot number and expiration date not reported). No adverse effects reported. Additional information has been requested.