chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.4
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Diarrhoea, Diet refusal, Emotional distress, Glassy eyes, Immediate post-injection reaction
Clinical narrative: Was given Hib Rotavirus, DTP, Hep B. Immediately started hysterical crying as soon as the vaccine was given. Continued from 11:00 to almost 4:00 that day when he finally fell asleep- would not nurse and could not be consoled. Assured that this is normal. Fever of 104 that evening and continue for the next three days and then it decreased to 101 for about three weeks. He continued getting fevers 99-101 degrees several times a month lasting for several days for the next five months (August 2007). Had no appetite for those three days and would drift in and out of sleep. Eyes were glassed over and he was not interactive (Which was very unlike him). He had been sleep for 6 -7 hours at a time prior to the vaccine and started only sleeping 1/2 hour up to 2 hours at a time if I held him. Very fussy when awake. What appeared to be seizures began after the first week. He would be completely unresponsive, put his fisted hands next to his head and shake with a blank stare. He would also begin shaking while nursing off to sleep. These seizure like behaviors continued until late August 2007 (about 5 months after the vaccines were given. He had horrible stomach pain and diarrhea that continued until he was almost three years old (October 2009). Was given Zantac which aggravated the problem. Was also tested for allergies. None were found.
Age: 0.4
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Irritability, Pyrexia, Seizure, Sleep disorder, Sleep paralysis
Clinical narrative: Was given Hib Rotavirus, DTP, Hep B. Immediately started hysterical crying as soon as the vaccine was given. Continued from 11:00 to almost 4:00 that day when he finally fell asleep- would not nurse and could not be consoled. Assured that this is normal. Fever of 104 that evening and continue for the next three days and then it decreased to 101 for about three weeks. He continued getting fevers 99-101 degrees several times a month lasting for several days for the next five months (August 2007). Had no appetite for those three days and would drift in and out of sleep. Eyes were glassed over and he was not interactive (Which was very unlike him). He had been sleep for 6 -7 hours at a time prior to the vaccine and started only sleeping 1/2 hour up to 2 hours at a time if I held him. Very fussy when awake. What appeared to be seizures began after the first week. He would be completely unresponsive, put his fisted hands next to his head and shake with a blank stare. He would also begin shaking while nursing off to sleep. These seizure like behaviors continued until late August 2007 (about 5 months after the vaccines were given. He had horrible stomach pain and diarrhea that continued until he was almost three years old (October 2009). Was given Zantac which aggravated the problem. Was also tested for allergies. None were found.
Age: 0.4
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Staring, Tremor, Unresponsive to stimuli
Clinical narrative: Was given Hib Rotavirus, DTP, Hep B. Immediately started hysterical crying as soon as the vaccine was given. Continued from 11:00 to almost 4:00 that day when he finally fell asleep- would not nurse and could not be consoled. Assured that this is normal. Fever of 104 that evening and continue for the next three days and then it decreased to 101 for about three weeks. He continued getting fevers 99-101 degrees several times a month lasting for several days for the next five months (August 2007). Had no appetite for those three days and would drift in and out of sleep. Eyes were glassed over and he was not interactive (Which was very unlike him). He had been sleep for 6 -7 hours at a time prior to the vaccine and started only sleeping 1/2 hour up to 2 hours at a time if I held him. Very fussy when awake. What appeared to be seizures began after the first week. He would be completely unresponsive, put his fisted hands next to his head and shake with a blank stare. He would also begin shaking while nursing off to sleep. These seizure like behaviors continued until late August 2007 (about 5 months after the vaccines were given. He had horrible stomach pain and diarrhea that continued until he was almost three years old (October 2009). Was given Zantac which aggravated the problem. Was also tested for allergies. None were found.
Age: 0.34
Sex: M
Vaccine: RV1
Symptoms: Incorrect route of drug administration
Clinical narrative: Rotarix vaccine given intramuscularly instead of by mouth.
Age: 59.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Dermatitis contact, Rash, Secretion discharge, Visual impairment
Clinical narrative: Had Rash that oozes, arms and legs, what appears to be contact dermatitis, but never had before, given steroid inj but did not help, flares up if eaten even a small amount of corn syrup or corn starch product.
Age: 59.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Dermatitis contact, Rash, Visual impairment
Clinical narrative: Had Rash that oozes, arms and legs, what appears to be contact dermatitis, but never had before, given steroid inj but did not help, flares up if eaten even a small amount of corn syrup or corn starch product.
Age: 3.0
Sex: M
Vaccine: MMR
Symptoms: Conjunctivitis, Ear infection, Ear pain, Pyrexia, Rash generalised
Clinical narrative: My son got the MMR shot on January 26th, 2015. Six days later he started with a fever that got very high, he started with pink eye and said his ears were hurting. My son had never had an ear ache before this. I took him into the doctors and they said he had a double ear infection. They gave him his first antibiotic and eye drops for conjunctivitis. That night his fever got even higher. I called the doctors office and asked if any of this could be related to the shot he had only 6 days before this all started. They said no way. He did get better after a few horrible days of a very high fever. He started with a rash on his face. Then his entire body. I searched online and the only rash I could compare it to was measles photos. It wasn't until the rash appeared that I started doing research online and was shocked to read ear infections and inflamed eyes were symptoms of measles. The first half of Feb., 6 days after the MMR shot, I had a very sick 3 year old. The sickest I've ever seen any of my 3 children.
Age: 21.0
Sex: M
Vaccine: SMALL
Symptoms: Rash morbilliform
Clinical narrative: Diffuse morbiliform type exanthem.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative
Clinical narrative: This spontaneous report was received from a physician and referred to a patient of unknown age and sex. On an unspecified date during childhood, the patient received an hepatitis B vaccine (manufacturer unknown) (lot #, expiration date, strength, dose and frequency were not reported). Then, on an unspecified date, the patient had a titer that was negative for hepatitis B surface antibodies. The outcome of the hepatitis B surface antibody negative was unknown. Action taken with the hepatitis B vaccine (manufacturer unknown) was not reported. The relatedness between the hepatitis B vaccine (manufacturer unknown) and the event of hepatitis B surface antibody negative was not reported. Additional information has been requested.
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling, redness at site of injection starting 2 days after administration.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling, Rash
Clinical narrative: Area surrounding injection site red and swollen. Ice to site.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site reaction, Joint range of motion decreased, Myalgia, Paraesthesia, X-ray
Clinical narrative: Left arm muscle sore at injection site, continued for several weeks, it has progressively worsened over time. I continued to expect it to improve, but it has now worsened and affects my range of motion with occasional tingling.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Fatigue, Injection site cellulitis, Pyrexia
Clinical narrative: Cellulitis at injection site, approx 30 x 15 cm, fever 102 F, chills, fatigue.
Age: 57.0
Sex: M
Vaccine: PPV
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: The patient reported left arm pain and swelling after receiving the vaccine. Advised to take TYLENOL 500mg q 12h prn for pain. No joint pain, muscle aches, HA otherwise. No bleeding, bruising. No numbness, tingling. No difficulty breathing or chest pain. No abd pain, nausea/vomiting, diarrhea. No rash.
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Head injury, Syncope
Clinical narrative: This spontaneous report as received from company representative who was reported by a healthcare worker refers to a female patient of unknown age. On an unknown date, the patient was vaccinated with first dose of GARDASIL injection (lot number, dose and route of administration was not reported). On an unknown date the patient experienced lightheaded, fainted and hit her head on the wall in the physician office after receiving GARDASIL. No laboratory details were provided. The patient was not treated for the reported events. The patient recovered from the reported events on unspecified date. The reported events were not considered as hospitalisation, cancer, life-threatening, disability or overdose.  No product quality complaint (PQC) was filed. No further information was available. Additional information is not expected as permission was not given to contact the health care provider.
Sex: F
Vaccine: HEP
Symptoms: Influenza like illness, Nasal discharge discolouration, Paraesthesia, Pyrexia
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of tingling of extremity in a female patient who received ENGERIX B adult (batch number 45SJ2, expiry date 17th February 2017). On 18th May 2015, the patient received ENGERIX B adult (intramuscular). On 18th May 2015, less than a day after receiving ENGERIX B adult, the patient experienced tingling of extremity, influenza-like symptoms, nasal discharge discoloration and fever. On an unknown date, the outcome of the tingling of extremity, influenza-like symptoms, nasal discharge discoloration and fever were recovered/resolved. The reporter considered the tingling of extremity, influenza-like symptoms and fever to be probably related to ENGERIX B adult. The reporter considered the nasal discharge discoloration to be unrelated to ENGERIX B adult. Additional information provided: The patient experienced the events within 24 hours of receiving the vaccine.
Age: 56.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, No therapeutic response
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of therapy non-responder in a female patient who received ENGERIX B. Co-suspect products included ENGERIX B. In July 2014, the patient received the 1st dose of ENGERIX B. On 1st January 2015, the patient received the 2nd dose of ENGERIX B 1 ml. On 21st May 2015, the patient received the 3rd dose of ENGERIX B. On an unknown date, an unknown time after receiving ENGERIX B, the patient experienced therapy non-responder. On an unknown date, the outcome of the therapy non-responder was unknown. Additional information provided: a patient received 3 doses of ENGERIX B but subsequent lab work showed "titer not sufficient". She does not have immunity, on 12 June 2015, a lab report showed quantity less than 5.
Age: 1.26
Sex: M
Vaccine: DTAP, FLU3
Symptoms: Aphasia, Lethargy
Clinical narrative: The evening after DTAP and influenza shot "lethargic that night" "like he was unplugged stopped talking. Parents reported this on 2/18/14; vaccines administered 11/21/13. Did not call office.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 03-JUN-2015, the patient was vaccinated with an improperly stored dose of VARIVAX (Merck) (administration route, lot number and expiration date were not provided). No concomitant therapies were reported. No adverse effects were reported. This is one of two reports from the same reporter. Additional information has been requested.
Age: 6.0
Sex: F
Vaccine: DTAPIPV, HEP, HEPA, MMRV, PNC13
Symptoms: Headache, Paraesthesia, Pyrexia
Clinical narrative: This patient was adopted and behind on immunizations. Given Dtap-IPV, PCV-13, Hep A and Hep B, MMRV on 6-25-15. On 6-26-15 after swimming, complained of HA, face tingling and fever 102. Gave MOTRIN-fever decreased no other symptoms.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 03-JUN-2015, the patient was vaccinated with an improperly stored dose of (Merck) VARIVAX (administration route, lot number and expiration date were not provided). No concomitant therapies were reported. No adverse effects were reported. This is one of two reports from the same reporter. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 66 year old female patient who in March or April 2014 was vaccinated with a first dose of ZOSTAVAX (dose, route, lot # and expiration date were not provided). Then on 29-JUN-2015, the patient was vaccinated with a second dose of ZOSTAVAX 19400 PFU, lot # L006381 (route was not provided), (extra dose administered). The extra dose was not intended to be a second dose; the patient did not remember that she had previously received ZOSTAVAX until she went home. The patient had not reported any adverse effects. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare student refers to a unspecified number of patients of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date the patients were vaccinated with a improperly stored GARDASIL  lot # J005679, expiration date 37-NOV-2015. The vaccine was exposed to -2C for 6 days. No adverse effects were reported. Additional information has been requested.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Hyperhidrosis, Rash, Rash macular, Skin warm
Clinical narrative: Patient woke up with chills and sweat. That has resided but warm, red blotches have begun to appear on his arm, leg and one on stomach.
Age: 2.0
Sex: M
Vaccine: HPV4
Symptoms: Wrong drug administered
Clinical narrative: Child brought to Clinic for routine vaccination - HIB. Given HPV4 IM Right Thigh in error. Vaccine administered by RN.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster disseminated
Clinical narrative: Per hospital pharmacist, patient was admitted on 6/21/15.  Hospital physician had a differential diagnosis of disseminated herpes zoster infection.  Patient started on IV Acyclovir and discharge on 6/26/15 with oral Acyclovir 200mg and Potassium 20 MEQ.
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Bursitis, Injection site pain, Mobility decreased, X-ray limb abnormal
Clinical narrative: Pain at site of injection and whole arm with decrease ROM.
Age: 78.0
Sex: F
Vaccine: PNC13
Symptoms: Rash
Clinical narrative: Pt developed a rash below the vaccine administration site.  The rash continued to spread down the arm. Pt went to prescriber where she was given a steroid medication.
Age: 0.64
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Extra dose administered
Clinical narrative: Vaccinations administered to pt per fathers request to update baby vaccines. Father returned this pm to state that Pts mother had child vaccinated in April this year. Pt vaccines given at current facility as follows. Rotavirus po, Prevnar 13 Pediarix, DTaP and HIB. Vaccinations given at first facility as follows Rotavirus, IVP, HIB, HepB, DTaP.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Blood test, Injection site pruritus, Swelling face, Throat irritation
Clinical narrative: Per Emergency room report. Patient started itching in the left upper extremity where Menactra vaccine was administered upon leaving clinic. Later patient started to complain of itching sensation in the throat and Mom noticed some swelling in the face. Mom gave him 25mg of Benadryl and took him in to Emergency room for further evaluation. IV was placed, Benadryl given and blood work was completed. Monitored for several hours with complete resolution of symptoms.
Age: 42.0
Sex: F
Vaccine: HEP
Symptoms: Injection site erythema, Lymph node pain, Pain, Pain in extremity, Vaccination site swelling
Clinical narrative: Tenderness in axillary lymph node area and in cervical lymph node area.  Lasted about three days.  Did not know if this was related to the administration of the vaccine.  However on 06/16/2015 was given vaccine #2 in the series and woke in the night with shooting pains down to her fingers on the same side as vaccine site with swelling redness and heat at vaccine site.
Age: 42.0
Sex: F
Vaccine: HEP
Symptoms: Vaccination site warmth
Clinical narrative: Tenderness in axillary lymph node area and in cervical lymph node area.  Lasted about three days.  Did not know if this was related to the administration of the vaccine.  However on 06/16/2015 was given vaccine #2 in the series and woke in the night with shooting pains down to her fingers on the same side as vaccine site with swelling redness and heat at vaccine site.
Age: 24.0
Sex: F
Vaccine: RUB
Symptoms: Anxiety disorder, Brain injury, Confusional state, Diarrhoea, Dizziness
Clinical narrative: Woke up dizzy, intense migraine, vomiting, diarrhea, confusion, muscle weakness, blurred vision. Went to the doctor and was diagnosed with chronic migraine. Twenty three years later still have chronic migraine with episodes of vertigo and anxiety disorder.
Age: 24.0
Sex: F
Vaccine: RUB
Symptoms: Electroencephalogram abnormal, Migraine, Muscular weakness, Nuclear magnetic resonance imaging normal, Vertigo
Clinical narrative: Woke up dizzy, intense migraine, vomiting, diarrhea, confusion, muscle weakness, blurred vision. Went to the doctor and was diagnosed with chronic migraine. Twenty three years later still have chronic migraine with episodes of vertigo and anxiety disorder.
Age: 24.0
Sex: F
Vaccine: RUB
Symptoms: Vision blurred, Vomiting
Clinical narrative: Woke up dizzy, intense migraine, vomiting, diarrhea, confusion, muscle weakness, blurred vision. Went to the doctor and was diagnosed with chronic migraine. Twenty three years later still have chronic migraine with episodes of vertigo and anxiety disorder.
Age: 24.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Bone pain, Headache
Clinical narrative: Headache, bone pain.
Age: 0.18
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RVX
Symptoms: Diarrhoea
Clinical narrative: Diarrhea - started recovering after 3-4 days. No treatment.
Age: 66.0
Sex: M
Vaccine: PNC13
Symptoms: Full blood count, Platelet count decreased
Clinical narrative: Decreased platelets.
Age: 14.0
Sex: M
Vaccine: HPV9
Symptoms: Chills, Headache, Nausea, Pyrexia
Clinical narrative: Child had fever 101.4, chills, headache & nausea.
Age: 1.35
Sex: F
Vaccine: DTAP, HEPA, HIBV, IPV, MMR, PPV, VARCEL
Symptoms: Allergy test positive, Allergy to vaccine, Seizure
Clinical narrative: Seizures.
Age: 1.41
Sex: F
Vaccine: DTAP
Symptoms: Herpes zoster, Rash
Clinical narrative: She had a small dot on her back which proceeded to produce many dots in a pattern in one section that moved around her torso towards her belly button. This lasted for a month and all we could do is cover her up so it would not pass on to any other family members. We also went to see her doctor on 3/28/2014 and she was diagnosed by Doctor with Shingles. She never once had chicken pox just the vaccine to prevent it.
Age: 49.0
Sex: M
Vaccine: FLU3
Symptoms: Hypoaesthesia, Mobility decreased, Musculoskeletal pain, Neck pain, Pain in extremity
Clinical narrative: Severe intermittent neck, shoulder and upper arm pain. Numbness in right thumb. Pain occurs when lying down, comes and goes when at rest.  Difficulty lifting arm out to side sometimes. Pain rated at 7-8/10 on pain scale at it's worse.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Urticaria
Clinical narrative: Large raised welt >10x12cm.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Gait disturbance, Injection site mass, Injection site pain, Musculoskeletal pain
Clinical narrative: Within a day or so after receiving the vaccine, her left arm became swollen and painful. There was a hard, round lump at the vaccine administration site. As weeks went by, the arm became increasingly painful to the extent that she could no longer sleep on her left side. The pain radiated up her shoulder. About one-year later, she developed an occasional shakiness in her left arm and subsequently developed a shakiness in her left leg, though pain-free & not as shaky as her arm. Her left leg soon began to drag; and she became chronically fatigued. All of this occurred over the course of around two years. While the above symptoms are classic symptoms of Parkinson's, it took nearly two years for her to receive a Parkinson's diagnosis. Her primary care physician wouldn't so much as entertain the possibility that the flu vaccine could bring on these symptoms, stating that "There is more Mercury in a can of tuna than in a vaccine;" and the neurologist who ultimately provided the P.D. diagnosis told her that the vaccine was merely the "red herring," and could not have resulted in her illness.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity, Parkinson's disease, Peripheral swelling, Sleep disorder, Tremor
Clinical narrative: Within a day or so after receiving the vaccine, her left arm became swollen and painful. There was a hard, round lump at the vaccine administration site. As weeks went by, the arm became increasingly painful to the extent that she could no longer sleep on her left side. The pain radiated up her shoulder. About one-year later, she developed an occasional shakiness in her left arm and subsequently developed a shakiness in her left leg, though pain-free & not as shaky as her arm. Her left leg soon began to drag; and she became chronically fatigued. All of this occurred over the course of around two years. While the above symptoms are classic symptoms of Parkinson's, it took nearly two years for her to receive a Parkinson's diagnosis. Her primary care physician wouldn't so much as entertain the possibility that the flu vaccine could bring on these symptoms, stating that "There is more Mercury in a can of tuna than in a vaccine;" and the neurologist who ultimately provided the P.D. diagnosis told her that the vaccine was merely the "red herring," and could not have resulted in her illness.
Age: 0.59
Sex: M
Vaccine: PNC13
Symptoms: Crying, Eczema, Hypersensitivity, Irritability, Personality change
Clinical narrative: Crying/fussy for remainder of day. Change in personality for 1 week. He did not smile or laugh and limited babbling for 1 week. Eczema/rash developed morning of 8/30/12.
Age: 0.59
Sex: M
Vaccine: PNC13
Symptoms: Rash
Clinical narrative: Crying/fussy for remainder of day. Change in personality for 1 week. He did not smile or laugh and limited babbling for 1 week. Eczema/rash developed morning of 8/30/12.
Age: 1.25
Sex: F
Vaccine: DTAP
Symptoms: Crying
Clinical narrative: Persistent crying for 5 hours.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pain in extremity
Clinical narrative: Pts arm was hurting and noticed large redness/swelling around injection site. It is warm to touch.
Age: 80.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: 10cm diameter of Erythma with heat at site of injection.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis
Clinical narrative: Pt presented with what looked like cellulitis.
Age: 22.0
Sex: F
Vaccine: TYP
Symptoms: Lip swelling, Rash generalised, Rash pruritic, Urticaria
Clinical narrative: Rash and hives all over body. Fat lip, itchy where the rash was.
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: PATIENT HAD REDNESS AND ITCHING AT SITE OF INJECTION.
Age: 21.0
Sex: M
Vaccine: HPV4
Symptoms: Dizziness, Exposure during pregnancy, Headache, Panic attack, Vision blurred
Clinical narrative: Blurred vision and headaches but have progresses to panic attacks and dizziness.
Age: 21.0
Sex: M
Vaccine: HPV4
Symptoms: Wrong drug administered
Clinical narrative: Blurred vision and headaches but have progresses to panic attacks and dizziness.
Age: 0.8
Sex: F
Vaccine: DTAP, IPV
Symptoms: Cognitive disorder, Irritability, Lethargy, Pyrexia, Somnolence
Clinical narrative: Patient became severely lethargic shortly after vaccination. On car ride home patient abruptly fell asleep at an abnormal time. Upon arriving home mother found it unusually difficult to awaken patient. After a short period of time, patient exhibited lower levels of cognition. Mother called Dr.'s office to discuss symptoms and potential side effects of Dtap vaccination. Doctor's office dismissed the symptoms as not related to the vaccination. Low grade fever and child fussiness ensued. Lower levels of cognition were observed by Mother, Father and Nanny from approximately 11 am till the next day. Father observed extremely low cognition around 3 pm when the child was otherwise highly energetic. At next pediatrician visit parents went through series of side effects the patient went through after the vaccination and again was dismissed as not being related to vaccine. Parents made the decision to terminate vaccination series.
Sex: M
Vaccine: IPV, MMR, TDAP
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: MMR vaccine given IM not subcutaneously. None reported at this time.
Age: 53.0
Sex: F
Vaccine: IPV, MMR, PPV
Symptoms: Incorrect route of drug administration
Clinical narrative: None reported at this time. MMR vaccine was given IM not subcutaenous.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Fatigue, Muscular weakness, Pyrexia
Clinical narrative: High fevers days, (fatigue, lower extremity weakness.) Still ongoing.
Age: 57.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site pruritus, Injection site scab, Injection site vesicles, Skin lesion
Clinical narrative: 2 small blisters near the site of injection about 2 weeks after the injection. They were initially itchy but scabbed & dried. A few days later a small lesion on her chin and upper right arm which are resolving.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, RV5
Symptoms: Dyspnoea, Feeding disorder of infancy or early childhood, Hyporesponsive to stimuli, Hypotonia
Clinical narrative: Pt went limp & began to breath hard & took a few seconds to respond to stimuli. Then did not eat well.
Age: 64.0
Sex: F
Vaccine: TDAP
Symptoms: Administration site rash, Administration site warmth, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Patient developed a warm red rash, tender to touch over the area/site of administration says it is "itchy" not painful. Had fever of over 100.5 degree F for 2 days.
Age: 64.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia
Clinical narrative: Patient developed a warm red rash, tender to touch over the area/site of administration says it is "itchy" not painful. Had fever of over 100.5 degree F for 2 days.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Fatigue, Injection site erythema, Injection site swelling, Local reaction
Clinical narrative: On 06-24-15 when patient woke up she had a 6 inch red swollen area at the injection site. Throughout the day she developed fatigue with body aches in her left arm, left shoulder, back of head, neck, and down her back. The body aches developed into a burning sensation like a sunburn. The body aches and burning sensation has worsened each day and remains present today. The local reaction at the injection site was gone by 06-27-2015.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: On 06-24-15 when patient woke up she had a 6 inch red swollen area at the injection site. Throughout the day she developed fatigue with body aches in her left arm, left shoulder, back of head, neck, and down her back. The body aches developed into a burning sensation like a sunburn. The body aches and burning sensation has worsened each day and remains present today. The local reaction at the injection site was gone by 06-27-2015.
Age: 16.0
Sex: F
Vaccine: PPV
Symptoms: Axillary pain, Cellulitis, Neck pain, Pain in extremity, Rash pruritic
Clinical narrative: 6/12/15 c/o sore arm and itchy rash around injection site some swelling. 6/13/15 Dx cellulitis Rt. arm. Pain in neck and Rt axilla. Rx with KEFLEX.
Age: 60.0
Sex: M
Vaccine: PNC13
Symptoms: Asthenia, Chills, Injection site pain, Pyrexia
Clinical narrative: The patient reported mild tenderness at the site of injection. Symptoms generalized weakness, chills and subject fever were also reported. The patient was advised to increase fluid intake, to rest and take TYLENOL or MOTRIN as needed. No further event was noted.
Sex: U
Vaccine: HBHEPB
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health care professional refers to an unspecified number of patients of unknown age and gender who since 08-SEP-2014 had been vaccinated with COMVAX (dose, route, lot # and expiration date were not provided) which were exposed to temperatures outside of the recommended range and assessed for stability. No adverse effects had been reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender who since 08-SEP-2014 had been vaccinated with doses of GARDASIL (lot # J011272, expiration date on 21-APR-2016 and lot # K006449 with expiration date on 19-JUN-2016), (route was not provided). The doses were exposed to temperatures outside of the recommended range and assessed for stability. No adverse effect has been reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal distension, Abdominal pain upper, Arthralgia, Blister, Musculoskeletal pain
Clinical narrative: This spontaneous reprot was received from a 75 year old male patient who reported for himself. The patient's current conditions were not reported. Pertinent medical history and history of drug allergies or reactions was none. Approximately in 2013 (July or August, 2 years ago), the patient was vaccinated with ZOSTAVAX (unknown strength) subcutaneous injection. Concomitant medications were none. On 05-JUN-2015, the patient started to experience pain and swelling in his stomach. The pain proceeded to his hip, legs and buttocks. He then started noticing blisters on his body. No lab diagnostic procedures were done. The patient sought medical attention and was seen by the physician on an unspecified date and the physician prescribed 800 mg acyclovir taken 5 times daily. The outcome of the events reported as not recovered. There was no product quality complaint involved. Causality assessment was not provided. Additional information has been requested.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This spontaneous reprot was received from a 75 year old male patient who reported for himself. The patient's current conditions were not reported. Pertinent medical history and history of drug allergies or reactions was none. Approximately in 2013 (July or August, 2 years ago), the patient was vaccinated with ZOSTAVAX (unknown strength) subcutaneous injection. Concomitant medications were none. On 05-JUN-2015, the patient started to experience pain and swelling in his stomach. The pain proceeded to his hip, legs and buttocks. He then started noticing blisters on his body. No lab diagnostic procedures were done. The patient sought medical attention and was seen by the physician on an unspecified date and the physician prescribed 800 mg acyclovir taken 5 times daily. The outcome of the events reported as not recovered. There was no product quality complaint involved. Causality assessment was not provided. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown age or gender. Pertinent medical history or drug allergies/drug reactions were not reported. On an unknown date, the patients were vaccinated with improperly stored ROTATEQ (lot # K016275, expiration date 20-APR-2016) (route, dose, strength and frequency were not reported). Concomitant medication was not reported. The reporter stated that the vaccine was exposed to 33 degrees F for 24 hours. No adverse effects were reported. Additional information has been requested.
Age: 41.0
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy, Fatigue, Wrong drug administered
Clinical narrative: This spontaneous prospective pregnancy report as received from a 41 year old female consumer referring to herself. The patient's medical history included papilloma viral infection (date and duration unspecified). The patient became pregnant with an estimated last menstrual period (LMP) on 19-NOV-2014 and estimated date of delivery (EDD) of 26-AUG-2015. She stated that she was prone for pre-term labor. On 17-JUN-2015, at 30 weeks pregnant, the patient was at her physician's office was supposed to be vaccinated with whooping cough vaccine (unspecified pertussis vaccine). Late that day, when the patient was at home, the physician's office called her and told they had mistakenly vaccinated her with GARDASIL or GARDASIL 9, the patient was not sure about which of them, in the right arm (dose, route, lot number and expiration date were not reported). Concomitant therapies included iron pills (manufacturer and dosage of prescription were unspecified). The patent also experienced fatigue that day. The pregnancy outcome was pending. The outcome of the events was unknown. The relatedness of fatigue with GARDASIL 9 or GARDASIL was not reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to a patient of unknown age and gender. Concurrent conditions, medical history and allergies were not reported. On 08-JUN-2015, the patient was vaccinated with one dose of (Merck) VARIVAX, (strength, dose, frequency, route and anatomical location were not reported), (lot # K015994 with expiration date: 23-SEP-2016), which was improperly stored. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a physician via a company representative concerning a patient of unknown age and gender. No concurrent conditions or medical history were provided. The patient was vaccinated with ZOSTAVAX (Lot No., expiration date, dose, route and administration date were not reported). On an unknown date, post vaccination the patient developed shingles (herpes zoster). The patient sought medical attention. The outcome of herpes zoster was unknown. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. Concurrent conditions, medical history and allergies were not reported. On 08-JUN-2015, the patient was vaccinated with a dose of ZOSTAVAX, intramuscularly, (strength, dose, frequency and anatomical location were not reported), (lot # K000326 with expiration date: 27-FEB-2015), which was expired. No adverse effects were reported. Additional information has been requested.
Age: 76.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: Information has been received from a healthcare worker referring to a 76 year old male patient without any drug reactions/allergies. Information about pertinent medical history was not reported. On 16-JUN-2015 the patient was vaccinated with PNEUMOVAX23 lot # K007826 with expiration date of 03-FEB-2016, 0.5 ml, intramuscularly. Concomitant therapy included unspecified albuterol inhaler. Later, on the same day the patient developed cellulitis just below the injection site. The patient was seen in the physician's office on 17-JUN-2015, and prescribed an unspecified antibiotic to treat the cellulitis. No lab diagnostic studies were performed. The outcome of the event was reported as not recovered. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site cellulitis
Clinical narrative: Information has been received from a healthcare worker referring to a patient of unknown age and gender. Information about pertinent medical history and concomitant therapy was not reported. On unspecified date the patient was vaccinated with PNEUMOVAX 23 (strength, dosage, frequency and route unspecified), lot # K007826 with expiration date of 03-FEB-2016. On an unspecified date, the patient experienced cellulitis just below the injection site. The outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a healthcare worker concerning three parents of unknown demographics. There were no medical history or drug reactions/allergies reported. On an unknown date in 2015, the patients were vaccinated with expired VARIVAX (Merck) (lot # J003218 with expiration date: 15-MAR-2015; dose, frequency and route were unspecified). No adverse events were reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse referring to unspecified patients of unknown age and gender. On unspecified dates, the patients were vaccinated with ROTATEQ which had been exposed to temperatures outside of the recommended range, (lot # K013868, expiry date 27-MAY-2016; lot# K020182, expiry date 25-JUN-2016), orally, (dose and frequency not reported). No adverse effect had been reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse referring to unspecified patients of unknown age and gender. On unspecified dates, the patients were vaccinated with GARDASIL which had been exposed to temperatures outside of the recommended range, (lot # K006960, expiry date 19-FEB-2017), (route, dose and frequency not reported). No adverse effect had been reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse referring to unspecified patients of unknown age and gender. On unspecified dates, the patients were vaccinated with RECOMBIVAX HB which has been exposed to temperatures outside of the recommended range, (lot # K017721, expiry date 27-AUG-2016; lot# K021444, expiry date 17-SEP-2016), (route, dose and frequency not reported). No adverse effects had been reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse referring to unspecified patients of unknown age and gender. On unspecified dates, the patients were vaccinated with VAQTA which had been exposed to temperatures outside of the recommended range, (lot # K005323, expiry date 10-FEB-2017; lot# K007827, expiry date 09-DEC-2016), (route, dose and frequency not reported). No adverse effect had been reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 05-JUN-2015, the patient was vaccinated with an improperly stored dose of VARIVAX (Merck), 0.5 ml, subcutaneous (lot number and expiration date were not provided). No concomitant therapies were reported. No adverse effects were reported. This is one of two reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 05-JUN-2015, the patient was vaccinated with an improperly stored dose of (Merck) VARIVAX, 0.5 ml, subcutaneous (lot number and expiration date were not provided). No concomitant therapies were reported. No adverse effects were reported. This is one of two reports from the same reporter. Additional information has been requested.
Age: 1.29
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Aphasia, Blood test, Crying, Cyanosis, Cytogenetic analysis normal
Clinical narrative: Seizures, High Fever, Site redness and swelling, fussy, blueness in lips and legs, excessive crying.  Three seizures over a 24 hour period.
Age: 1.29
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Electroencephalogram abnormal, Injection site erythema, Injection site reaction, Injection site swelling, Irritability
Clinical narrative: Seizures, High Fever, Site redness and swelling, fussy, blueness in lips and legs, excessive crying.  Three seizures over a 24 hour period.
Age: 1.29
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Nuclear magnetic resonance imaging, Pyrexia, Seizure
Clinical narrative: Seizures, High Fever, Site redness and swelling, fussy, blueness in lips and legs, excessive crying.  Three seizures over a 24 hour period.
Age: 37.0
Sex: M
Vaccine: MMR
Symptoms: Chills, Deafness, Feeling hot, Hyperhidrosis, Pain
Clinical narrative: Ringing in the ear, hearing loss, body aches, hot sweats, fever, chills.
Age: 37.0
Sex: M
Vaccine: MMR
Symptoms: Pyrexia, Tinnitus
Clinical narrative: Ringing in the ear, hearing loss, body aches, hot sweats, fever, chills.
Age: 1.84
Sex: F
Vaccine: DTAPIPVHIB, MMR
Symptoms: Pyrexia, Rash
Clinical narrative: I discovered a rash on her abdomin which was followed by a high fever of 103.7. I am waiting for the doctors office to open so I can schedule an appt or talk to a nurse.
Age: 13.0
Sex: M
Vaccine: HPV4
Symptoms: Loss of consciousness
Clinical narrative: Passed out.
Age: 42.0
Sex: M
Vaccine: TDAP
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pain, swelling & redness at site of vaccination. Diagnosed as cellulitus per urgent care visit documentation (The patient presented to the urgent care 5/1) onset of symptoms 1 day ago (4/30/2015) no other information known re: specific time course.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Erythema, Local swelling, Vaccination site reaction, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Large raised, swollen area of redness (also hot) on thigh at vaccine site.  Also large raised, area of redness in groin area.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a healthcare worker referring to an unspecified number of patients of unknown age and gender. On unknown dates the patients were vaccinated with improperly stored an unspecified number patients received improperly stored GARDASIL (strength, lot#, dosage, route and frequency). This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a healthcare worker referring to an unspecified number of patients of unknown age and gender. On unknown dates the patients were vaccinated with improperly stored ROTATEQ (strength, lot#, dosage and frequency), orally. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to an unspecified amount of patients of unknown age and gender. No medical history, current conditions and concomitant therapies were reported. On an unknown date in June 2015, the patients received GARDASIL (lot #, expiration date, dose and route of administration were not reported) that was improperly stored on unspecified dates between 10-JUN-2015 through 22-JUN-2015. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions and allergies were not reported. On 19-JUN-2015, the patient was vaccinated with (Oka/Merck) VARIVAX (lot#L001326, expiration date: 13-JAN-2017; dose, route of administration and anatomical location were not reported) that was improperly stored. No adverse events were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions and allergies were not reported. ON 19-JUN-2015, the patient was vaccinated with VARIVAX (Merck) (lot#L001327, expiration date: 13-JAN-2017; dose, route of administration and anatomical location were not reported) that was improperly stored. No adverse events were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to a multiple patients of unknown age and gender. There were no concomitant medications, concurrent conditions and medical history reported. On an unknown date, the patient was vaccinated with VAQTA lot # J0055713 expiration date 25-OCT-2015 and lot # K018182 expiration date 12-DEC-2016 (dose was not reported). The patient received a dose of VAQTA that was stored improperly. There was no adverse effects reported. Additional information has been requested.