chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Injection site cellulitis, Lymphadenopathy, Sensation of heaviness
Clinical narrative: Tdap shot was given in right arm, flu shot in left which resolved in 6 days.  The Tdap shot caused greater swelling in lymph nodes under arm, but severe redness kept getting worse, not better, esp. after 4-5 days (hot to touch). Area was swollen, the day I went in to urgent care at the nurse's recommendation it was more swollen and I could see the redness moving down my arm (like an armband around both sides) so went in. The urgent care Rx gave me an antibiotic due to cellulitis at the shot site. After 2 days of antibiotics it is resolving.  The red swollen area was 8"x6"x3". My arm bothered me the last 2 days with itching and felt "heavy".
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Dysphonia, Dyspnoea, Eye pruritus, Urticaria
Clinical narrative: SHORTNESS OF BREATH, HIVES, ITCHY EYES, HOARSENESS OF VOICE.
Age: 22.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Induration, Local swelling, Pain in extremity, Skin warm
Clinical narrative: Swollen, raised, hard, red circle around arm. Warm to the touch and painful.
Age: 53.0
Sex: M
Vaccine: TYP
Symptoms: Angioedema, Hyperhidrosis, Lip swelling, Throat tightness
Clinical narrative: Developed lips swelling, throat tightened, diaphoresis = angioedema.
Age: 26.0
Sex: F
Vaccine: MEN
Symptoms: Chills, Headache, Influenza like illness, Local swelling, Nausea
Clinical narrative: Extreme body ache, headache, nausea, swelling of arm administered in, fever, chills, poor regulation of temperature, flu-like symptoms >48 hours.
Age: 26.0
Sex: F
Vaccine: MEN
Symptoms: Pain, Pyrexia, Temperature regulation disorder
Clinical narrative: Extreme body ache, headache, nausea, swelling of arm administered in, fever, chills, poor regulation of temperature, flu-like symptoms >48 hours.
Age: 33.0
Sex: M
Vaccine: ANTH, FLUN4
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Large localized swelling at injection site, redness, hot to the touch, itchy.
Age: 0.36
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV1
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Misadministered Vaccine: varicella vaccine given to 4 mo old.
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Injection site reaction, Muscular weakness, Paraesthesia
Clinical narrative: Pt experienced tingling sensation radiating from site of injection, at time of injection, radiated down to 2nd digit left hand. 9/30/14 pt reports weakness in left hand at 1st and 2nd digit, left wrist pain.  Pt seen in the office 9/30/14, started on NSAID gel and antibiotic.  10/1/14 pt to schedule an appointment with a neurologist.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Dermatitis acneiform, Rash vesicular
Clinical narrative: Patient reported that she developed rash on back of neck, arms and underarms. No pain (+) itch. States it looks like chickenpox. Spoke with her physician - not seen - call if worsens.
Age: 1.0
Sex: F
Vaccine: HEPA, HIBV, PNC13, VARCEL
Symptoms: Injection site reaction, Rash, Rash maculo-papular, Rash papular, Urticaria
Clinical narrative: Rash on trunk and legs developed within 48 hours. Rash on legs was consistent with bug bits, urticarial with central papule. Rash on trunk was maculopapular and distinct from leg rash. Supportive care was recommended.
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema
Clinical narrative: Arm where injection given turned a little red around injection site.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Injection site erythema, Injection site pain, Vaccination site induration, Vaccination site swelling
Clinical narrative: Confirmed with imms nurse, my son received ProQuad to the right thigh - Since vaccination, over the course of 1 week, his vaccine site swelled and became indurated and redness spread across his right thigh. Red, not itchy, but tender. Approximately, covered 2/3 of anterior aspect of his thigh.
Age: 53.0
Sex: F
Vaccine: FLU4, PPV, TDAP
Symptoms: Body temperature increased, Chills, Dizziness, Erythema, Headache
Clinical narrative: Started with body chills, headache, temp 102.8, nausea. Headache lasted 24 hours. Next day when temp went down started to have swelling in her R arm not where vaccines given, lower towards her bicep. Called Dr. office and spoke with nurse for Dr. who reported typical reaction in arm and to call back if worse.  By Friday arm was twice the size, redness and hot to touch. Seen by PCP who did not think it was cellulitis, took pt she received 2 unnecessary vaccines and was not happy about pt receiving Flu and Pneumovax 23 in same right deltoid. Was told to take Benadryl and use ice packs. Pt unhappy with PCP response. She called allergist office and spoke with nurse. Not sure this is new allergy to eggs, pt reports eats eggs daily. Recommended that pt receive flu shot be given by allergist next year.  Not sure if this is a true reaction to flu shot.  Pt reports 20 years ago she had reaction to first flu shot, was dizzy for 3 days.  Has had flu shot almost every year since and no problems.  Pt will follow up with allergist.
Age: 53.0
Sex: F
Vaccine: FLU4, PPV, TDAP
Symptoms: Injection site swelling, Nausea, Skin warm
Clinical narrative: Started with body chills, headache, temp 102.8, nausea. Headache lasted 24 hours. Next day when temp went down started to have swelling in her R arm not where vaccines given, lower towards her bicep. Called Dr. office and spoke with nurse for Dr. who reported typical reaction in arm and to call back if worse.  By Friday arm was twice the size, redness and hot to touch. Seen by PCP who did not think it was cellulitis, took pt she received 2 unnecessary vaccines and was not happy about pt receiving Flu and Pneumovax 23 in same right deltoid. Was told to take Benadryl and use ice packs. Pt unhappy with PCP response. She called allergist office and spoke with nurse. Not sure this is new allergy to eggs, pt reports eats eggs daily. Recommended that pt receive flu shot be given by allergist next year.  Not sure if this is a true reaction to flu shot.  Pt reports 20 years ago she had reaction to first flu shot, was dizzy for 3 days.  Has had flu shot almost every year since and no problems.  Pt will follow up with allergist.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Abnormal behaviour, Autism, Decreased eye contact, Diagnostic procedure, Encephalopathy
Clinical narrative: Noticed that patient became less responsive, less eye contact was shown, began stemming behavior, still non-verbal, began to be unresponsive to surrounding environment. . .retreated within himself.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Hyporesponsive to stimuli, Social avoidant behaviour, Speech disorder developmental, Unresponsive to stimuli
Clinical narrative: Noticed that patient became less responsive, less eye contact was shown, began stemming behavior, still non-verbal, began to be unresponsive to surrounding environment. . .retreated within himself.
Age: 66.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Decreased appetite, Eyelid disorder, Fatigue, Feeling hot, Influenza like illness
Clinical narrative: patient very fatigued, felt warm, loss of appetite, flu-like symptoms 9/26: patient's right eyelid black and blue, resolved within three days.
Age: 66.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Skin discolouration
Clinical narrative: patient very fatigued, felt warm, loss of appetite, flu-like symptoms 9/26: patient's right eyelid black and blue, resolved within three days.
Age: 2.0
Sex: F
Vaccine: DTAP
Symptoms: Agitation, Gait disturbance, Injection site swelling, Vaccination complication
Clinical narrative: When she woke up from her nap, she wasn't walking well, really limping, her leg was quite swollen and she was very agitated. By bedtime (7pm) we had to carry her everywhere. At 7:30PM I called the doctor's office. They advised me to give her some Motrin to help her sleep and this was a mild reaction.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Flushing, Headache, Somnolence, Swollen tongue
Clinical narrative: Felt flush, light headed, tongue swelled was like that for a minute or two then symptoms subsided. Currently left with slight headache, dizziness, and sleepy.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site rash
Clinical narrative: Rash at injection site (3 inches x 4 inches).
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Feeling abnormal, Headache, Injection site pain, Pyrexia
Clinical narrative: Mother reports pain at the site, fever of 101-102 degrees Fahrenheit, headache, and general "bad feeling". Patient has been taking ibuprofen every four hours. NP recommended Tylenol every 4-6 hours, for 2-3 days, and cool compresses to the site. NP recommended seeking medical attention if the fever were to climb above 102 or the headache worsens, with medication. We will follow up with the patient in three days.
Age: 43.0
Sex: F
Vaccine: FLUX
Symptoms: Pain, Pruritus
Clinical narrative: 1st day pt had itching and bodyaches, 2nd day pt had pruritis of the arm.
Age: 43.0
Sex: F
Vaccine: FLUX
Symptoms: Erythema, Local swelling, Mobility decreased, Pain in extremity
Clinical narrative: Pt's right arm was swollen, red, and had pain 6/10, pt also had limited movement.
Age: 1.04
Sex: F
Vaccine: DTAPIPVHIB, HEP, HEPA, MMR, PNC13, VARCEL
Symptoms: Rash generalised, Rash papular
Clinical narrative: Grandmother came to clinic on 9/30/2014 with child, said child got rash the day after the vaccines was administered. Generalized papular rash noted to include head and soles of feet.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Nausea
Clinical narrative: Dizziness, nausea.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Chills, Decreased appetite, Fatigue, Headache
Clinical narrative: Severe chills without fever, extreme fatigue, 12 hours sleep, 24 hours joint  head ache, loss of appetite for 24 hours, 48+ hours inflammation and redness at inection site.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site inflammation
Clinical narrative: Severe chills without fever, extreme fatigue, 12 hours sleep, 24 hours joint  head ache, loss of appetite for 24 hours, 48+ hours inflammation and redness at inection site.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Headache, Injection site reaction, Myalgia
Clinical narrative: Pt called 10/1/14 to report headache and aching muscles in shoulder of vaccination, but no fever. His vaccination was around 9am 9/30/14 and onset of symptoms was around 3pm 9/30/14. Spoke with pt at 1:45pm 10/1/14 and he says symptoms have almost completely resolved. Pt requested his reaction be reported to the appropriate agency.
Age: 37.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site pain
Clinical narrative: Severe, recurrent pain at the injection site, left lower deltoid.
Age: 78.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Diarrhoea, Headache, Vomiting
Clinical narrative: Patient stated that he experienced vomiting for about an hour and a half, slight headache, and diarrhea for about 7-8 hours.  The patient stated that he had ate food at a friends house but stated that no other person who ate had gotten sick.  He also stated that he had received other injections from MD which included a steroid shot an an unknown injection stated by the patient. I tried to call Dr to see which injections were given but was unable to reach him.  The patient did say that he felt normal with no ill effects from the day previous.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Body temperature increased, Malaise, Pain
Clinical narrative: Severe malaise, body aches, and oral temp of 38.8 developed within 4 hours of administration requiring employee to go home sick mid-shift. Symptoms gradually improved over the next 24 hours until resolved. No further symptoms of infection or illness observed during 72 hours post vaccination.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site induration, Injection site rash, Injection site reaction, Pain, Pruritus
Clinical narrative: Rash, itching, pain. Patient also described the area around the injection site as being "hard" and "tight." Symptoms were almost resolved by 10/1/14. There was sill a quarter-sized rash on 10/1/14 around the injection site. Unknown if any attempts were made to treat the reaction.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Skin tightness
Clinical narrative: Rash, itching, pain. Patient also described the area around the injection site as being "hard" and "tight." Symptoms were almost resolved by 10/1/14. There was sill a quarter-sized rash on 10/1/14 around the injection site. Unknown if any attempts were made to treat the reaction.
Age: 71.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site pain, Injection site pruritus
Clinical narrative: Pain, stinging, itch left uppper arm. Had requested to receive 2 vaccines in the same arm.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity, Pruritus, Swelling face
Clinical narrative: Patient c/o itchy feet and face. Awoke the next day with swollen itchy face and aching arm.
Age: 38.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Dizziness, Feeling abnormal, Feeling cold, Myalgia
Clinical narrative: I got the flu shot in the morning, and by the evening, had a very strong reaction to the flu shot - in the evening, I felt strong body and muscle aches, chills (could not get warm enough until got a winter down blanket). I felt generally very itchy. I was also very dizzy the next morning.
Age: 38.0
Sex: F
Vaccine: FLUX
Symptoms: Pain
Clinical narrative: I got the flu shot in the morning, and by the evening, had a very strong reaction to the flu shot - in the evening, I felt strong body and muscle aches, chills (could not get warm enough until got a winter down blanket). I felt generally very itchy. I was also very dizzy the next morning.
Age: 71.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: Arm was sore that night, by the next night she noticed small red bumps near injection site.  Patient came to the pharmacy 9/30/14 to report/show rash on upper arm.  It was approx 5x3", warm, red, slightly swollen and tender. She was given antibiotics by her dermatologist she saw earlier that day for unrelated reasons.
Age: 71.0
Sex: M
Vaccine: PPV
Symptoms: Pain in extremity, Rash erythematous
Clinical narrative: Arm was sore that night, by the next night she noticed small red bumps near injection site.  Patient came to the pharmacy 9/30/14 to report/show rash on upper arm.  It was approx 5x3", warm, red, slightly swollen and tender. She was given antibiotics by her dermatologist she saw earlier that day for unrelated reasons.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia oral, Paraesthesia, Swollen tongue
Clinical narrative: Reported "swollen tongue" with "numbness" to right side of tongue and "slight tingling to my neck that just lasted a minute" that started approximately 30 minutes after administration. Swelling did not impair speech, swallowing, or breathing. Symptoms improved throughout the day.
Age: 36.0
Sex: M
Vaccine: DTAPHEPBIP, FLU3, DTAPHEPBIP
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: No signs or symptoms of adverse reaction.
Age: 36.0
Sex: M
Vaccine: DTAPHEPBIP, FLU3, DTAPHEPBIP
Symptoms: Drug administered to patient of inappropriate age, No adverse event, Underdose, Wrong drug administered
Clinical narrative: No signs or symptoms of adverse reaction.
Age: 49.0
Sex: F
Vaccine: FLU3, PPV, PPV
Symptoms: Injection site swelling, Neuralgia, Pain
Clinical narrative: Deltoid area has swollen up severely about 4 times size, neuritic complaints with any motion or movement of shoulder IV Solu Medrol x 1 ordered with diphenhydramine 25mg po.
Age: 49.0
Sex: F
Vaccine: FLU3, PPV, PPV
Symptoms: Extensive swelling of vaccinated limb, Injection site erythema, Injection site pain
Clinical narrative: Deltoid area has swollen up severely about 4 times size, neuritic complaints with any motion or movement of shoulder IV Solu Medrol x 1 ordered with diphenhydramine 25mg po.
Age: 1.34
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Threw out the day my daughters leg got a big red circle, under that was a large bump under the injection site the got bigger, it is warm to touch and she has a low grade fever.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site reaction, Rash erythematous
Clinical narrative: Red rash at injection site.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Pharyngeal oedema, Pruritus, Swelling face
Clinical narrative: Itching, swollen face and throat, chest tightness.
Age: 75.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Asthenia, Blood pressure increased, Chills, Dyspnoea, Headache
Clinical narrative: Adverse event started approximately two hours after flu shot - weakness, fever, increased bp, trouble breathing, chills, headache.
Age: 75.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Pyrexia
Clinical narrative: Adverse event started approximately two hours after flu shot - weakness, fever, increased bp, trouble breathing, chills, headache.
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient complained that the redness and swelling started few hours after she received the flu vaccine. She reported it to me on 10/1/14 @ 1200 pm.  The R deltoid area still had some redness and swelling (6.5 cm), slight warm to touch.  NO other complaints.
Age: 9.0
Sex: F
Vaccine: FLUN4, HPV4
Symptoms: Abdominal pain upper, Dizziness, Feeling cold, Flushing, Headache
Clinical narrative: Immediately following vaccination patient complained of arm pain and was holding her arm very rigid. She walked to a chair immediately outside the room because she did not want to see her brother get shots. About 5 minutes later she came back in room and was pale and lethargic. Sat her down in a chair. She said her stomach hurt and she felt like she was going to throw up and that she was not hearing very good. She vomited a large amount. Color immediately came back to her face. She was diaphoretic but stated she was cold. She vomited a 2nd time about 2-3 minutes later and a 3rd time about 5-10 minutes after that. Throughout she described waxing and waning stomach pain, waxing and waning hearing decrease and she would regain color and then become flushed again. These effects happened at least 5 times in the ~45min she sat in the vaccination room. About 40 minutes after her initial symptoms she said her stomach was feeling better but she now had a headache and was dizzy. She was also lethargic. At this time she felt like she was ready to go home. Father was instructed that if symptoms reoccurred to take child to the urgent care for examination. He verbally understood.
Age: 9.0
Sex: F
Vaccine: FLUN4, HPV4
Symptoms: Hyperhidrosis, Hypoacusis, Immediate post-injection reaction, Lethargy, Mobility decreased
Clinical narrative: Immediately following vaccination patient complained of arm pain and was holding her arm very rigid. She walked to a chair immediately outside the room because she did not want to see her brother get shots. About 5 minutes later she came back in room and was pale and lethargic. Sat her down in a chair. She said her stomach hurt and she felt like she was going to throw up and that she was not hearing very good. She vomited a large amount. Color immediately came back to her face. She was diaphoretic but stated she was cold. She vomited a 2nd time about 2-3 minutes later and a 3rd time about 5-10 minutes after that. Throughout she described waxing and waning stomach pain, waxing and waning hearing decrease and she would regain color and then become flushed again. These effects happened at least 5 times in the ~45min she sat in the vaccination room. About 40 minutes after her initial symptoms she said her stomach was feeling better but she now had a headache and was dizzy. She was also lethargic. At this time she felt like she was ready to go home. Father was instructed that if symptoms reoccurred to take child to the urgent care for examination. He verbally understood.
Age: 9.0
Sex: F
Vaccine: FLUN4, HPV4
Symptoms: Nausea, Pain in extremity, Pallor, Vomiting
Clinical narrative: Immediately following vaccination patient complained of arm pain and was holding her arm very rigid. She walked to a chair immediately outside the room because she did not want to see her brother get shots. About 5 minutes later she came back in room and was pale and lethargic. Sat her down in a chair. She said her stomach hurt and she felt like she was going to throw up and that she was not hearing very good. She vomited a large amount. Color immediately came back to her face. She was diaphoretic but stated she was cold. She vomited a 2nd time about 2-3 minutes later and a 3rd time about 5-10 minutes after that. Throughout she described waxing and waning stomach pain, waxing and waning hearing decrease and she would regain color and then become flushed again. These effects happened at least 5 times in the ~45min she sat in the vaccination room. About 40 minutes after her initial symptoms she said her stomach was feeling better but she now had a headache and was dizzy. She was also lethargic. At this time she felt like she was ready to go home. Father was instructed that if symptoms reoccurred to take child to the urgent care for examination. He verbally understood.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Myalgia, Neck pain, Nodule, Pain
Clinical narrative: The patient states that she received the vaccine 9/26/14 and other than muscle soreness she had no adverse effects until Sunday evening. She noticed a "painful, squishy nodule" on her left collar bone close to her neck. She said it was making her entire neck sore. She came to our pharmacy and said the pain is not getting any worse but it is still bothering her.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Paraesthesia
Clinical narrative: Patient received flu vaccination in the left deltoid.  After 15 minute waiting period, patient felt tingling in the 4th and 5th digits of the left hand.
Age: 36.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Cough, Diarrhoea, Fatigue, Hyperhidrosis
Clinical narrative: 7pm dry cough. 8pm severe chills and body aches lasted 2 hours took Tylenol. 2AM woke up in a sweat. 6AM woke up with migraine, very sore at injection site, swollen very sore sinuses under my eyes, fatigued. 1:30PM severe diarrhea.
Age: 36.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site pain, Injection site swelling, Migraine, Pain, Sinus headache
Clinical narrative: 7pm dry cough. 8pm severe chills and body aches lasted 2 hours took Tylenol. 2AM woke up in a sweat. 6AM woke up with migraine, very sore at injection site, swollen very sore sinuses under my eyes, fatigued. 1:30PM severe diarrhea.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Hallucination, Pyrexia
Clinical narrative: Fever, chills, hallucinations.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Myalgia
Clinical narrative: 2hrs following vaccination myalgias began, getting progressively worse, eventually severe, resolved 10/1/14.
Age: 26.0
Sex: M
Vaccine: TTOX
Symptoms: Influenza like illness, Malaise
Clinical narrative: GENERAL MALAISE SYMPTOMS, FLU-LIKE SYMPTOMS
Age: 60.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Injection site pain, Malaise, Myalgia, Pyrexia
Clinical narrative: Injection site-soreness and pain. Systemic-muscle pain, malaise, chills, fever (101.2).
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site reaction, Muscle spasms
Clinical narrative: Cramping of upper back muscles; cramping @ injection site.
Age: 4.0
Sex: F
Vaccine: FLU3
Symptoms: Local swelling, Urticaria
Clinical narrative: Patient's arm become really swollen.  It looked like a huge welt.
Age: 51.0
Sex: F
Vaccine: FLUX
Symptoms: Feeling cold, Headache, Injection site pain, Nausea, Restless legs syndrome
Clinical narrative: Very sore arm at site, then I got very very cold, chilled to the bone cold. Then headache and restless legs for about three hours, nausea, woke with a very bad headache.
Age: 48.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Per RN patient received the Pneumoccal vaccine in her left arm. The next morning there was redness, swelling, and warmth at injection site. Patient received 25 mg po Benadryl the following day 8/27/14. We followed the patient until discharge and the injection site returned to normal.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Patient had red area at site of injection. She said it felt hot, hard and some swelling. No itching was experienced. She was going to apply cold compresses.  She was at work and was to return so we could see if it helped. She did not return to pharmacy.
Age: 29.0
Sex: F
Vaccine: FLU4
Symptoms: Dermatitis, Injection site pruritus, Injection site reaction, Pruritus, Rash papular
Clinical narrative: Patient said that 2 hours after administration of vaccine had itchiness at area of injection (left arm). Took Allegra Monday night. Tuesday a.m. itchiness was now starting on right arm as well, and more profound, as well as "small round pimple-like dermatitis" from wrist to shoulder apparent on BOTH arms. Took Allegra again. By Wed a.m. itchiness partially had gone down, but rash was there.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site rash, Injection site warmth
Clinical narrative: Patient complained of a large rash, approximately 3-4 inches in diameter located ~3-5 inches below the actually injection site (left deltoid muscle) on the left arm. She had no fever or discomfort but said it was warm to the touch.  She said she used Benadryl and was going to try some NSAIDs, such as ibuprofen.
Age: 1.03
Sex: M
Vaccine: DTAP
Symptoms: Abasia, Dyskinesia, Pain, Psychomotor skills impaired, Screaming
Clinical narrative: Decreased talked, severe jerking movements when sleeping (never happened prior), waking up screaming, seems to be in pain, decrease in motor skills, was walking no longer doing so.
Age: 1.03
Sex: M
Vaccine: DTAP
Symptoms: Speech disorder
Clinical narrative: Decreased talked, severe jerking movements when sleeping (never happened prior), waking up screaming, seems to be in pain, decrease in motor skills, was walking no longer doing so.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Malaise, Pyrexia
Clinical narrative: Patient reported chills, fever, malaise. Considered going to ER, chose not to do so. Patient reports feeling back to normal as of this morning (10-1-14). Based on what he described, I estimate his symptoms did not appear for at least 2-3 hours and were greatly improved well within 24 hours.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Injection site pain, Rash vesicular
Clinical narrative: Rash with raised blister like bumps, headache, soreness at injection site.
Age: 22.0
Sex: F
Vaccine: FLUX
Symptoms: Dizziness, Flushing, Nausea, Tremor
Clinical narrative: Dizzy, light headed, flushed, nauseous and shaky.
Age: 50.0
Sex: F
Vaccine: FLU3, PPV, VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient shown redness and swelling around the injection sites.
Age: 1.01
Sex: M
Vaccine: MMRV
Symptoms: Allergy test, Injection site discolouration, Injection site erythema, Injection site mass, Injection site swelling
Clinical narrative: Injection area swelled, turned bright red, and felt like 20 pea sized balls under skin. Applied cold pack to cool warm spot down. Spot turned purple, more lumps occurred. For one week, patient had hives rash all over body, at least 4 times a day. Extremely bad hives. Physician had us give patient Benadryl. Sept 30 the hives resided, as well as the spot at the injection site.
Age: 1.01
Sex: M
Vaccine: MMRV
Symptoms: Injection site warmth, Rash generalised, Skin test, Urticaria
Clinical narrative: Injection area swelled, turned bright red, and felt like 20 pea sized balls under skin. Applied cold pack to cool warm spot down. Spot turned purple, more lumps occurred. For one week, patient had hives rash all over body, at least 4 times a day. Extremely bad hives. Physician had us give patient Benadryl. Sept 30 the hives resided, as well as the spot at the injection site.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Death
Clinical narrative: This spontaneous report from an adverse event tweet as received via social media from a consumer refers to a healthy 12 year old female patient. On an unknown date, the patient was vaccinated with GARDASIL (route, lot # and expiration date were not provided). The reporting consumer published the following: healthy 12 year old girl died, on an unknown date, after unspecified HPV vaccine. It was unknown if the patient sought medical attention. It was unknown if autopsy was performed. The cause of death was not provided. The reporting consumer stated her daughter (nor son) would never get this vaccine. Clarification was received that the social media AE documented two different tweets, by two different twitter users, about the same 1 patient, regarding GARDASIL. Additional information is not expected, as there is no consent for followup.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Adverse drug reaction, Drug hypersensitivity, Mammogram, Rash, Scleroderma
Clinical narrative: This spontaneous report as received from a 79 year old female consumer diagnosed sometime in 2011 with breast cancer and heart fibrillation referring to herself. On 12-OCT-2012 the patient was vaccinated with a dose of ZOSTAVAX, subcutaneous, (dose, dose number, lot number and expiration date were unspecified). Other concomitant therapies included BACTRIM, DILANTIN, PRADAXA, simvastatin (manufacturer unknown), METRAZOL (also reported as METRAZOLE), letrozole, a generic multivitamin (unspecified), Vitamin D3, biotin and Vitamin B12. On an unknown date, the patient was two or three day at the hospital for special surgery (unspecified). The patient also experienced, on an unspecified date, rash after using DILANTIN and an unspecified reaction while using BACTRIM so patient's physician thought she may be allergic to sulfa products. The patient also stated that, at the time of this report, she was currently undergoing treatment for scleroderma but could not specify if this occurred prior to or post receiving ZOSTAVAX. A mammogram and a sonogram were performed to the patient on unspecified dates (results were not reported). The patient sought medical attention, reported as "I went to the hospital". The outcome of surgery, rash and unspecified reaction was reported as unknown. The outcome of scleroderma was reported as not recovered/not resolved. Upon internal review, special surgery (unspecified) was determined to be medically significant. Additional information is not expected because the reporter refused additional contact.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Surgery, Ultrasound scan
Clinical narrative: This spontaneous report as received from a 79 year old female consumer diagnosed sometime in 2011 with breast cancer and heart fibrillation referring to herself. On 12-OCT-2012 the patient was vaccinated with a dose of ZOSTAVAX, subcutaneous, (dose, dose number, lot number and expiration date were unspecified). Other concomitant therapies included BACTRIM, DILANTIN, PRADAXA, simvastatin (manufacturer unknown), METRAZOL (also reported as METRAZOLE), letrozole, a generic multivitamin (unspecified), Vitamin D3, biotin and Vitamin B12. On an unknown date, the patient was two or three day at the hospital for special surgery (unspecified). The patient also experienced, on an unspecified date, rash after using DILANTIN and an unspecified reaction while using BACTRIM so patient's physician thought she may be allergic to sulfa products. The patient also stated that, at the time of this report, she was currently undergoing treatment for scleroderma but could not specify if this occurred prior to or post receiving ZOSTAVAX. A mammogram and a sonogram were performed to the patient on unspecified dates (results were not reported). The patient sought medical attention, reported as "I went to the hospital". The outcome of surgery, rash and unspecified reaction was reported as unknown. The outcome of scleroderma was reported as not recovered/not resolved. Upon internal review, special surgery (unspecified) was determined to be medically significant. Additional information is not expected because the reporter refused additional contact.
Age: 56.0
Sex: M
Vaccine: FLU4
Symptoms: Asthenia, Balance disorder, Blood creatine phosphokinase increased, Computerised tomogram head normal, Computerised tomogram thorax normal
Clinical narrative: Patient experienced altered mental status, fever, imbalance and lower extremity weakness. Was hospitalized from 9/24-9/26. Discharged 9/26.
Age: 56.0
Sex: M
Vaccine: FLU4
Symptoms: Echocardiogram normal, Electrocardiogram normal, Laboratory test normal, Mental status changes, Muscular weakness
Clinical narrative: Patient experienced altered mental status, fever, imbalance and lower extremity weakness. Was hospitalized from 9/24-9/26. Discharged 9/26.
Age: 56.0
Sex: M
Vaccine: FLU4
Symptoms: Pyrexia, Troponin increased, Urinary tract infection
Clinical narrative: Patient experienced altered mental status, fever, imbalance and lower extremity weakness. Was hospitalized from 9/24-9/26. Discharged 9/26.
Age: 0.12
Sex: F
Vaccine: FLU3
Symptoms: Body temperature increased, Culture throat negative, Culture urine negative, Cyanosis, Eye movement disorder
Clinical narrative: 7/30/14 temp 101.6 no other symptoms advised to give TYLENOL. 10:30 pm child was twitching eyes rolled back child was limp. Dad thought blue gave mouth rescue breaths, Seen at hospital.
Age: 0.12
Sex: F
Vaccine: FLU3
Symptoms: Full blood count normal, Hypotonia, Influenza virus test negative, Muscle twitching, Respiratory syncytial virus test negative
Clinical narrative: 7/30/14 temp 101.6 no other symptoms advised to give TYLENOL. 10:30 pm child was twitching eyes rolled back child was limp. Dad thought blue gave mouth rescue breaths, Seen at hospital.
Age: 0.12
Sex: F
Vaccine: FLU3
Symptoms: Resuscitation, Urine analysis normal
Clinical narrative: 7/30/14 temp 101.6 no other symptoms advised to give TYLENOL. 10:30 pm child was twitching eyes rolled back child was limp. Dad thought blue gave mouth rescue breaths, Seen at hospital.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Redness, warmth and itching to site. Prednisone 40 mg given to in office on 10/1/14. Script given for 30 mg for 1 week. Also advise to take BENADRYL 25 mg q 6 hours. Recheck in office in 48 hours. Erythema (10 cm x 10 cms)
Sex: F
Vaccine: MMR, PNC13, VARCEL
Symptoms: Pyrexia
Clinical narrative: This spontaneous report as received from a physician via other company refers to 15 month old female patient. On 05-AUG-2014 the patient was vaccinated with a dose of MMR II (dose, route and lot # not reported). Other suspect therapies included given on the same date (Oka/Merck) VARIVAX (dose, route and lot # not reported) and PREVENAR (dose, route and lot # not reported. On unspecified date in 2014 the patient experienced fever. The outcome of fever was unknown. The relatedness between fever and MMR II, (Oka/Merck) VARIVAX and PREVNAR was not reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a patient of unknown demographics. No relevant medical history of the patient was reported. On 29-MAR-2013 the patient was vaccinated with ZOSTAVAX dose 1, subcutaneous (strength, lot number, expiration date and site of administration were not reported). It was reported that the patient received the second dose of ZOSTAVAX on 29-SEP-2014, subcutaneous (strength, lot number, expiration date and site of administration were not reported). There were no concomitant medications reported. There were no known adverse effects. The patient's present status was reported as no known adverse effects. It was unspecified if the patient had sought any medical attention. There was no product quality complaint (PQC) involved. The outcome was unknown. The action taken with ZOSTAVAX was not applicable. The causality was not reported. Additional information has been requested.
Age: 86.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Body temperature increased, Dizziness, Fatigue, Feeling abnormal, Tremor
Clinical narrative: Increased temp. Shaking. Dizziness. Called Dr. on call. Concluded reaction to ZOSTAVAX. High dose flu in past OK. Progressively better tho night. 9/29 still "not right" very tired.
Age: 62.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Arthralgia, Dizziness, Fatigue, Feeling of body temperature change, Myalgia
Clinical narrative: Fatigue, soreness in joints and muscles of entire body, dizziness (3+ days), shaking, hot and cold.
Age: 62.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Tremor
Clinical narrative: Fatigue, soreness in joints and muscles of entire body, dizziness (3+ days), shaking, hot and cold.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Medical history and drug reactions or allergies were not specified. On 15-SEP-2014, the patient received an expired dose of PNEUMOVAX23 lot number H021941, expiration date 11-JUL-2014, dose 0.5 ml, intramuscular. No symptoms were reported. Concomitant medications were not specified. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 43.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Injected limb mobility decreased
Clinical narrative: Client reports pain in arm that has continued 13 + days. Reports difficulty raising her left arm. 9-30-14 client examined by provider, determined normal shoulder exam of LA.
Age: 60.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Erythema, Local swelling, Pain in extremity
Clinical narrative: Patient had upper arm extremely swollen and may be edemic. Upper arm was intensely erythemic and patient is in a lot of pain. This occurred a day or 2 after ZOSTAVAX was given. I advised to take a BENADRYL if it may be an allergy, talk with CDC, who said it was not.
Age: 6.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Skin warm, Staphylococcal infection
Clinical narrative: < 24 hours after injection the pt's arm began to turn red, feel hot to the touch, these signs worsened over the next 12 hours. The child was seen by his primary care provider and diagnosed with a staph infection. He was treated with an antibiotic injection and oral antibiotics. The redness and warmth have resolved.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Within 24 hour period, arm hard around injection site and warm to touch. Swollen too. Advised to go see doctor. Patient called today on 9/19/14.
Age: 65.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Diarrhoea, Malaise, Nausea
Clinical narrative: Very severe diarrhea until tool 6 IMODIUM - took 1 every hour until 6 pm. At 4 pm got chills, nausea and felt sick. Called doctor who advised her to ride it out. Still has chills.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal distension, Asthenia, Chills, Diarrhoea, Feeling abnormal
Clinical narrative: Pt has taken flu vax for 10 years with no problems. By night did not feel right, was bloated, had nausea, tad of diarrhea. 30 minute later when got home, had chills, fever, felt freezing, was moaning in pain because felt muscles constricted. Had headache took ADVIL and also pill for nausea. Fever did not break until AM. For 24 hours felt weak, had heavy breathing. In the morning called the doctor but was too weak to go. Still had some diarrhea on AM but was able to keep some food down. Friday morning felt better but was still slow to get going. Today feels fine.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling cold, Headache, Hyperventilation, Moaning, Muscle tightness
Clinical narrative: Pt has taken flu vax for 10 years with no problems. By night did not feel right, was bloated, had nausea, tad of diarrhea. 30 minute later when got home, had chills, fever, felt freezing, was moaning in pain because felt muscles constricted. Had headache took ADVIL and also pill for nausea. Fever did not break until AM. For 24 hours felt weak, had heavy breathing. In the morning called the doctor but was too weak to go. Still had some diarrhea on AM but was able to keep some food down. Friday morning felt better but was still slow to get going. Today feels fine.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Pain, Pyrexia
Clinical narrative: Pt has taken flu vax for 10 years with no problems. By night did not feel right, was bloated, had nausea, tad of diarrhea. 30 minute later when got home, had chills, fever, felt freezing, was moaning in pain because felt muscles constricted. Had headache took ADVIL and also pill for nausea. Fever did not break until AM. For 24 hours felt weak, had heavy breathing. In the morning called the doctor but was too weak to go. Still had some diarrhea on AM but was able to keep some food down. Friday morning felt better but was still slow to get going. Today feels fine.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date of patients received improperly stored doses of M-M-R II (lot # reported as K001997, expiry date reported as: 10-FEB-2016, therapy type, dosage, route of administration, anatomical location were not reported), which were exposed 8.5C for 15 minutes. No adverse effect were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date the patients received improperly stored doses of M-M-R II (lot # reported as: J013431, expiry date reported as: 24-OCT-2014, therapy type, dosage, route of administration, anatomical location were not reported), which were exposed to 8.5C for 15 minutes. No adverse effect were reported. Thi sis one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date the patients received improperly stored doses of M-M-R II (lot reported as: K003823, expiry date reported as: 14-MAR-2015, therapy type, dosage, route of administration, anatomical location were not reported), which were exposed 8.5C for 15 minutes. No adverse effect were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacist refers to an approximately 65 year old female patient. On 11-FEB-2013, the patient was vaccinated with ZOSTAVAX 19400 plaque forming units (PFU), dose, lot number, expiration date not reported. Concomitant therapies included diazepam, tramadol hydrochloride, and baclofen. On unspecified date in 2013, within 6 months after receiving ZOSTAVAX, the patient developed shingles. The patient received unspecified antiviral medication for treatment of the adverse event. The patient sought medical attention - contacted pharmacist (way of contact not reported). The outcome of shingles was reported as recovered (date not reported). The outcome of shingles was reported as recovered (date not reported). Relatedness between the event and ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On an unknown date, reported as: only 2 or 3 weeks after administration of (Oka/Merck) VARIVAX (dose, route, lot# and expiration date were unknown), the patient was vaccinated with a dose of M-M-R II (dose, route, lot # and expiration date were unknown). No adverse events were reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Drug dose omission, Liquid product physical issue, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker (office manager) reporting on behalf of the physician, refers to a patient of unknown demographics. No concurrent conditions or medical history were provided. The reporter stated that due to the fact that 2 vials of (Oka/Merck) VARIVAX injection (dose, route of administration, indication, lot# and expiry date unspecified) had an unusual appearance, a patient missed a dose on an unknown date. No concomitant medications were reported. No adverse event was reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 12-SEP-2014 the patient was vaccinated with an expired dose of (RECOMBIVAX HB) (lot # J001183, expiration date: 08-SEP-2014, dosage unknown, intramuscular. No known adverse effects. Additional information has been requested.
Age: 0.38
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare professional who reported that in January 2014, 21 improperly stored doses of ROTATEQ (oral, dose, batch and lot number not reported) were administered by a clinic to an unspecified number of patients (age and gender were not reported). No adverse effects were reported. This is one of several reports from the same source.   Follow up information has been received on 17-MAR-2014. All telephone attempts to obtain follow-up information had been unsuccessful.   Follow up information has been received on 22-SEP-2014. Demographic details for each patient were provided. This report referred to a 7-months old patient of unspecified gender, with no known drug allergies and no illness at the time of vaccination. The patient was vaccinated with the second dose of ROTATEQ (oral, batch/lot #J004875, expiration date 17-OCT-2014), on 21-JAN-2014 at 10:30 AM. It was reported that this dose was spoiled since the refrigerator was too cold (onset of event also reported as 27-FEB-2014 at 10:00 AM). The parents of the patient were going to consult with physician to repeat the dose at no charge. No adverse event was reported for the patient. The reporter reported the outcome as unknown. This is one of several reports from the same source. Additional information is not expected since all follow ups requested to complete the case were received.