chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Constipation, Frequent bowel movements, Malaise, Musculoskeletal pain, Paraesthesia
Clinical narrative: Information has been received from a pharmacist concerning a 60 year old male patient. The patient did not have drug reactions/allergies or pertinent medical history. On 05-DEC-2015, the patient was vaccinated with a dose of ZOSTAVAX, lot # L031272, expiration date 19-NOV-2016, subcutaneously. Concomitant therapies included tramadol hydrochloride, minocycline and escitalopram. On 07-DEC-2015, 2 days after the vaccination, the patient experienced tingly skin, injection site redness and constipation. Since an unknown date in December 2015, the patient had been having more frequent bowel movements, but he was still having shoulder pain and general malaise. No treatment was given for the events. No lab diagnostics studies were performed. On 11-DEC-2015, the patient called the pharmacist to report the events and seek unspecified medical attention. Over time the injection redness went away on an unspecified date in December 2015 and there was no rash. The outcome of tingly skin, constipation, more frequent bowel movements, shoulder pain and general malaise was resolving. The relatedness of the events and ZOSTAVAX was not provided. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Constipation, Frequent bowel movements, Injection site erythema, Malaise, Musculoskeletal pain
Clinical narrative: Information has been received from a pharmacist concerning a 60 year old male patient. The patient did not have drug reactions/allergies or pertinent medical history. On 05-DEC-2015, the patient was vaccinated with a dose of ZOSTAVAX, lot # L031272, expiration date 19-NOV-2016, subcutaneously. Concomitant therapies included tramadol hydrochloride, minocycline and escitalopram. On 07-DEC-2015, 2 days after the vaccination, the patient experienced tingly skin, injection site redness and constipation. Since an unknown date in December 2015, the patient had been having more frequent bowel movements, but he was still having shoulder pain and general malaise. No treatment was given for the events. No lab diagnostics studies were performed. On 11-DEC-2015, the patient called the pharmacist to report the events and seek unspecified medical attention. Over time the injection redness went away on an unspecified date in December 2015 and there was no rash. The outcome of tingly skin, constipation, more frequent bowel movements, shoulder pain and general malaise was resolving. The relatedness of the events and ZOSTAVAX was not provided. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Paraesthesia
Clinical narrative: Information has been received from a pharmacist concerning a 60 year old male patient. The patient did not have drug reactions/allergies or pertinent medical history. On 05-DEC-2015, the patient was vaccinated with a dose of ZOSTAVAX, lot # L031272, expiration date 19-NOV-2016, subcutaneously. Concomitant therapies included tramadol hydrochloride, minocycline and escitalopram. On 07-DEC-2015, 2 days after the vaccination, the patient experienced tingly skin, injection site redness and constipation. Since an unknown date in December 2015, the patient had been having more frequent bowel movements, but he was still having shoulder pain and general malaise. No treatment was given for the events. No lab diagnostics studies were performed. On 11-DEC-2015, the patient called the pharmacist to report the events and seek unspecified medical attention. Over time the injection redness went away on an unspecified date in December 2015 and there was no rash. The outcome of tingly skin, constipation, more frequent bowel movements, shoulder pain and general malaise was resolving. The relatedness of the events and ZOSTAVAX was not provided. Additional information has been requested.
Age: 62.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Erythema, Pruritus, Rash
Clinical narrative: This spontaneous report was received from a pharmacist regarding a 62 year old male patient. The patient did not have any concurrent conditions, allergies and medical history. On 08-DEC-2015, the patient was vaccinated with ZOSTAVAX with lot number # L031271, (expiry date: 19-NOV-2015) at a dose of 0.65 ml via subcutaneous route (anatomical location unknown). Concomitant therapies included CIALIS and finasteride (manufacturer unknown). On an unknown date, after vaccination with ZOSTAVAX the patient called back to the pharmacy to report that he had developed an unspecified rash "starting on his left arm that spread to both hands, then the rash moved to his head, face and neck but not his lower extremities". No lab tests was performed. The treatment provided to the patient included BENADRYL (manufacturer unknown). The outcome of the event was unknown. The relatedness of the event with the suspect product ZOSTAVAX was unknown. No product quality complaint was reported. Additional information has been requested.
Age: 62.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Rash
Clinical narrative: This spontaneous report was received from a pharmacist regarding a 62 year old male patient. The patient did not have any concurrent conditions, allergies and medical history. On 08-DEC-2015, the patient was vaccinated with ZOSTAVAX with lot number # L031271, (expiry date: 19-NOV-2015) at a dose of 0.65 ml via subcutaneous route (anatomical location unknown). Concomitant therapies included CIALIS and finasteride (manufacturer unknown). On an unknown date, after vaccination with ZOSTAVAX the patient called back to the pharmacy to report that he had developed an unspecified rash "starting on his left arm that spread to both hands, then the rash moved to his head, face and neck but not his lower extremities". No lab tests was performed. The treatment provided to the patient included BENADRYL (manufacturer unknown). The outcome of the event was unknown. The relatedness of the event with the suspect product ZOSTAVAX was unknown. No product quality complaint was reported. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU3, MMRV, DTAPIPV, FLU3, MMRV
Symptoms: Abasia, Balance disorder, Cough, Gait disturbance, Hypertonia
Clinical narrative: 10/16/2015 4:00 PM  Talking funny and pulling at face. 10/17/2015 5:00 PM Tripping on feet. 10/19/2015 4:00 PM Preschool teacher notes toe walking. Took for new shoes in next size. 10/20/2015 2:00 PM  Fell more when running during soccer game. 10/22/2015 4:00 PM Tired more than usual and very sweaty even at rest. 8:00 PM could not get out of the bathtub or walk. 10/23/2015 9:00 AM Increased sweating, legs could not bear weight. Took to pediatrician. Admitted to Medical Center.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU3, MMRV, DTAPIPV, FLU3, MMRV
Symptoms: Hyporeflexia, Muscle contracture, Muscular weakness, Musculoskeletal stiffness, Tendon disorder
Clinical narrative: 10/16/2015 4:00 PM  Talking funny and pulling at face. 10/17/2015 5:00 PM Tripping on feet. 10/19/2015 4:00 PM Preschool teacher notes toe walking. Took for new shoes in next size. 10/20/2015 2:00 PM  Fell more when running during soccer game. 10/22/2015 4:00 PM Tired more than usual and very sweaty even at rest. 8:00 PM could not get out of the bathtub or walk. 10/23/2015 9:00 AM Increased sweating, legs could not bear weight. Took to pediatrician. Admitted to Medical Center.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU3, MMRV, DTAPIPV, FLU3, MMRV
Symptoms: Tetanus
Clinical narrative: 10/16/2015 4:00 PM  Talking funny and pulling at face. 10/17/2015 5:00 PM Tripping on feet. 10/19/2015 4:00 PM Preschool teacher notes toe walking. Took for new shoes in next size. 10/20/2015 2:00 PM  Fell more when running during soccer game. 10/22/2015 4:00 PM Tired more than usual and very sweaty even at rest. 8:00 PM could not get out of the bathtub or walk. 10/23/2015 9:00 AM Increased sweating, legs could not bear weight. Took to pediatrician. Admitted to Medical Center.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU3, MMRV, DTAPIPV, FLU3, MMRV
Symptoms: Abasia, Abnormal behaviour, Blood albumin normal, Blood creatine phosphokinase increased, Blood gases abnormal
Clinical narrative: 10/16/2015 4:00 PM  Talking funny and pulling at face. 10/17/2015 5:00 PM Tripping on feet. 10/19/2015 4:00 PM Preschool teacher notes toe walking. Took for new shoes in next size. 10/20/2015 2:00 PM  Fell more when running during soccer game. 10/22/2015 4:00 PM Tired more than usual and very sweaty even at rest. 8:00 PM could not get out of the bathtub or walk. 10/23/2015 9:00 AM Increased sweating, legs could not bear weight. Took to pediatrician. Admitted to Medical Center.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU3, MMRV, DTAPIPV, FLU3, MMRV
Symptoms: Blood lactic acid increased, Blood thyroid stimulating hormone normal, Cytogenetic analysis normal, Demyelination, Differential white blood cell count normal
Clinical narrative: 10/16/2015 4:00 PM  Talking funny and pulling at face. 10/17/2015 5:00 PM Tripping on feet. 10/19/2015 4:00 PM Preschool teacher notes toe walking. Took for new shoes in next size. 10/20/2015 2:00 PM  Fell more when running during soccer game. 10/22/2015 4:00 PM Tired more than usual and very sweaty even at rest. 8:00 PM could not get out of the bathtub or walk. 10/23/2015 9:00 AM Increased sweating, legs could not bear weight. Took to pediatrician. Admitted to Medical Center.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU3, MMRV, DTAPIPV, FLU3, MMRV
Symptoms: Electroencephalogram normal, Electromyogram abnormal, Fall, Fatigue, Gait disturbance
Clinical narrative: 10/16/2015 4:00 PM  Talking funny and pulling at face. 10/17/2015 5:00 PM Tripping on feet. 10/19/2015 4:00 PM Preschool teacher notes toe walking. Took for new shoes in next size. 10/20/2015 2:00 PM  Fell more when running during soccer game. 10/22/2015 4:00 PM Tired more than usual and very sweaty even at rest. 8:00 PM could not get out of the bathtub or walk. 10/23/2015 9:00 AM Increased sweating, legs could not bear weight. Took to pediatrician. Admitted to Medical Center.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU3, MMRV, DTAPIPV, FLU3, MMRV
Symptoms: Gastrointestinal examination normal, Haematocrit decreased, Haemoglobin decreased, Hyperhidrosis, Immunology test normal
Clinical narrative: 10/16/2015 4:00 PM  Talking funny and pulling at face. 10/17/2015 5:00 PM Tripping on feet. 10/19/2015 4:00 PM Preschool teacher notes toe walking. Took for new shoes in next size. 10/20/2015 2:00 PM  Fell more when running during soccer game. 10/22/2015 4:00 PM Tired more than usual and very sweaty even at rest. 8:00 PM could not get out of the bathtub or walk. 10/23/2015 9:00 AM Increased sweating, legs could not bear weight. Took to pediatrician. Admitted to Medical Center.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU3, MMRV, DTAPIPV, FLU3, MMRV
Symptoms: Liver function test normal, Lumbar puncture normal, Mobility decreased, Nuclear magnetic resonance imaging brain normal, Nuclear magnetic resonance imaging spinal normal
Clinical narrative: 10/16/2015 4:00 PM  Talking funny and pulling at face. 10/17/2015 5:00 PM Tripping on feet. 10/19/2015 4:00 PM Preschool teacher notes toe walking. Took for new shoes in next size. 10/20/2015 2:00 PM  Fell more when running during soccer game. 10/22/2015 4:00 PM Tired more than usual and very sweaty even at rest. 8:00 PM could not get out of the bathtub or walk. 10/23/2015 9:00 AM Increased sweating, legs could not bear weight. Took to pediatrician. Admitted to Medical Center.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU3, MMRV, DTAPIPV, FLU3, MMRV
Symptoms: Peripheral sensorimotor neuropathy, Protein total normal, Speech disorder, Toe walking, Toxicologic test normal
Clinical narrative: 10/16/2015 4:00 PM  Talking funny and pulling at face. 10/17/2015 5:00 PM Tripping on feet. 10/19/2015 4:00 PM Preschool teacher notes toe walking. Took for new shoes in next size. 10/20/2015 2:00 PM  Fell more when running during soccer game. 10/22/2015 4:00 PM Tired more than usual and very sweaty even at rest. 8:00 PM could not get out of the bathtub or walk. 10/23/2015 9:00 AM Increased sweating, legs could not bear weight. Took to pediatrician. Admitted to Medical Center.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU3, MMRV, DTAPIPV, FLU3, MMRV
Symptoms: Weight bearing difficulty
Clinical narrative: 10/16/2015 4:00 PM  Talking funny and pulling at face. 10/17/2015 5:00 PM Tripping on feet. 10/19/2015 4:00 PM Preschool teacher notes toe walking. Took for new shoes in next size. 10/20/2015 2:00 PM  Fell more when running during soccer game. 10/22/2015 4:00 PM Tired more than usual and very sweaty even at rest. 8:00 PM could not get out of the bathtub or walk. 10/23/2015 9:00 AM Increased sweating, legs could not bear weight. Took to pediatrician. Admitted to Medical Center.
Age: 66.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Pain in extremity
Clinical narrative: This initial spontaneous report was received from a pharmacist referring to a 66 year old male patient with diabetes and with no drug reaction/allergies. On 08-DEC-2015, the patient was vaccinated with ZOSTAVAX injection (lot# L026415 with expiration date 15-OCT-2016; dose and route were not provided). There was no concomitant medication reported. Immediately following administration of ZOSTAVAX, the patient experienced persistent pain at the injection site "that went down his arm". The patient sought medical attention (pharmacy visit) but treatment was not given for the events. Lab diagnostics studies were not performed. Product quality complaint (PQC) was involved. At the time of the report, the outcome of the events was not recovered. The causality assessment was not reported. Additional information has been requested.
Age: 66.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: This initial spontaneous report was received from a pharmacist referring to a 66 year old male patient with diabetes and with no drug reaction/allergies. On 08-DEC-2015, the patient was vaccinated with ZOSTAVAX injection (lot# L026415 with expiration date 15-OCT-2016; dose and route were not provided). There was no concomitant medication reported. Immediately following administration of ZOSTAVAX, the patient experienced persistent pain at the injection site "that went down his arm". The patient sought medical attention (pharmacy visit) but treatment was not given for the events. Lab diagnostics studies were not performed. Product quality complaint (PQC) was involved. At the time of the report, the outcome of the events was not recovered. The causality assessment was not reported. Additional information has been requested.
Age: 69.0
Sex: M
Vaccine: FLUX
Symptoms: Chills, Cold sweat, Headache, Nausea, Tremor
Clinical narrative: Chills, Nausea, Cold Sweat, Uncontrollable shaking, Headache.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Food allergy, Haemorrhage, Hypersensitivity, Inflammation
Clinical narrative: Rash, extremely itchy, first traveled up vein on right arm (thought maybe Shingles)-moved to both sides, small raised bumps, red patches, easily became inflamed and bled. 11/17/2015-Went to clinic at 3:30 PM-diagnosed as possible flu shot reaction-possible Eczema, given steroid shot and a course of oral steroids (started 4 for two day, then 3 for two days, etc.), told I should get relief from itching later that evening. 11/18/2015 through 11/24/2015 continued to itch and the rash spread from arms to torso and legs. 11/24/2015-Returned to clinic, diagnosed as allergic reaction to flu shot with an egg allergy, told I needed to watch how much egg I ate each day, given another round of oral steroids starting at 4/4, given Atarax.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Rash, Rash pruritic
Clinical narrative: Rash, extremely itchy, first traveled up vein on right arm (thought maybe Shingles)-moved to both sides, small raised bumps, red patches, easily became inflamed and bled. 11/17/2015-Went to clinic at 3:30 PM-diagnosed as possible flu shot reaction-possible Eczema, given steroid shot and a course of oral steroids (started 4 for two day, then 3 for two days, etc.), told I should get relief from itching later that evening. 11/18/2015 through 11/24/2015 continued to itch and the rash spread from arms to torso and legs. 11/24/2015-Returned to clinic, diagnosed as allergic reaction to flu shot with an egg allergy, told I needed to watch how much egg I ate each day, given another round of oral steroids starting at 4/4, given Atarax.
Age: 21.0
Sex: F
Vaccine: FLUX
Symptoms: Blood test, Electrocardiogram, Pain in extremity, Peripheral swelling, X-ray
Clinical narrative: Arm swelled up very big and lots of pain.
Age: 0.52
Sex: M
Vaccine: DTAP
Symptoms: Seizure
Clinical narrative: Initial unsolicited report received from a consumer (patient's mother) on 18 December 2015. This case involves a six-month-old male patient who was vaccinated with a dose of DTAP (batch number, route and site of administration were not reported) on 22 June 2015. The patient's medical history of illness at time of vaccination and allergies were reported as none, birth defects, medical conditions were not reported. The patient's concomitant medications were not reported. On 22 June 2015, few hours (two to three hours) following the vaccination, the patient had experienced seizure. On the same day, the patient had visited pediatrician. On an unspecified date, two weeks after the first episode of seizure, the patient had experienced another episode of seizures and till date 18 December 2015 the patient had not experienced any further seizures. The patient required ER/doctor visit. Laboratory data and corrective treatment were reported as the patient was evaluated and was treated by the pediatrician. The outcome of the event was unknown. Upon internal review the case was considered as serious because of important medical event seizure. List of documents held by sender: none.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered at inappropriate site, Injection site joint pain, Injection site pain
Clinical narrative: Injection site was high on shoulder, soreness at injection site has not resolved and has worsened and migrated to shoulder joint as of today 12/28/2015.
Age: 42.0
Sex: F
Vaccine: PPV, TDAPIPV
Symptoms: Cellulitis, Erythema, Pain, Peripheral swelling, Pyrexia
Clinical narrative: Swelling, redness of the upper arm area, pain, fever 104,- Developed Cellulitis, prescribed antibiotics for 7 days.
Age: 87.0
Sex: F
Vaccine: PNC13
Symptoms: Activities of daily living impaired, Balance disorder, Cerebrovascular accident, Computerised tomogram, Deafness unilateral
Clinical narrative: Patient received a PREVNAR 13 injection Monday 11/23/15. The evening of 11/24/15 she noticed some difficulty hearing. The morning of Wed 11/25/15, she had lost all hearing in her right ear, had difficulty dressing and walking (lack of balance). As Wed. 11/24/15 progressed, patient's vision and speech were off, by Wed. afternoon she was feeling nauseous and started vomiting and then into dry heaves. All together, patient's symptoms seemed stroke like. She was transported to hospital where she spent Wed. night, 11/25/15 in the emergency room and was admitted into the hospital the morning of Thursday 11/26/15.
Age: 87.0
Sex: F
Vaccine: PNC13
Symptoms: Gait disturbance, Nausea, Nuclear magnetic resonance imaging, Retching, Speech disorder
Clinical narrative: Patient received a PREVNAR 13 injection Monday 11/23/15. The evening of 11/24/15 she noticed some difficulty hearing. The morning of Wed 11/25/15, she had lost all hearing in her right ear, had difficulty dressing and walking (lack of balance). As Wed. 11/24/15 progressed, patient's vision and speech were off, by Wed. afternoon she was feeling nauseous and started vomiting and then into dry heaves. All together, patient's symptoms seemed stroke like. She was transported to hospital where she spent Wed. night, 11/25/15 in the emergency room and was admitted into the hospital the morning of Thursday 11/26/15.
Age: 87.0
Sex: F
Vaccine: PNC13
Symptoms: Visual impairment, Vomiting
Clinical narrative: Patient received a PREVNAR 13 injection Monday 11/23/15. The evening of 11/24/15 she noticed some difficulty hearing. The morning of Wed 11/25/15, she had lost all hearing in her right ear, had difficulty dressing and walking (lack of balance). As Wed. 11/24/15 progressed, patient's vision and speech were off, by Wed. afternoon she was feeling nauseous and started vomiting and then into dry heaves. All together, patient's symptoms seemed stroke like. She was transported to hospital where she spent Wed. night, 11/25/15 in the emergency room and was admitted into the hospital the morning of Thursday 11/26/15.
Age: 60.0
Sex: M
Vaccine: FLU4
Symptoms: CSF test, CSF test abnormal, Diplopia, Dysarthria, Gait disturbance
Clinical narrative: Received vaccine on Nov 5, 2015. Two+ weeks later developed double vision, slurred speech, unsteady gait, numbness. L.P., MRI done - both abn. Tx'd with IV SOLU-MEDROL, oral steroids.
Age: 60.0
Sex: M
Vaccine: FLU4
Symptoms: Hypoaesthesia, Nuclear magnetic resonance imaging abnormal
Clinical narrative: Received vaccine on Nov 5, 2015. Two+ weeks later developed double vision, slurred speech, unsteady gait, numbness. L.P., MRI done - both abn. Tx'd with IV SOLU-MEDROL, oral steroids.
Age: 5.0
Sex: F
Vaccine: FLU3
Symptoms: Electroencephalogram abnormal, Mycoplasma test positive, Seizure
Clinical narrative: 5 days after receiving FLUZONE, patient had a seizure at home and was subsequently admitted to hospital. EEG done in hospital showed abnormal activity temporal lobe and she had positive IgM mycoplasma. She was advised to see neurologist and take Rx antiepileptic medicine.
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Dry mouth, Feeling abnormal, Hypoaesthesia oral, Injection site swelling, Lip injury
Clinical narrative: Swelling inside upper & lower lips; teeth cutting inside lips; some foggy thinking first few days; sore arm with swelling at the injection site (right arm), stiff neck - mostly on right side; after 2-weeks started with dry mouth and numbness on inside upper and lower lips.
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Lip swelling, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Swelling inside upper & lower lips; teeth cutting inside lips; some foggy thinking first few days; sore arm with swelling at the injection site (right arm), stiff neck - mostly on right side; after 2-weeks started with dry mouth and numbness on inside upper and lower lips.
Age: 52.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Fatigue, Injection site swelling, Rash
Clinical narrative: Pt c/o redness, patchy looking skin, and swelling of arm where injection was placed. She also c/o extreme fatigue.
Age: 57.0
Sex: M
Vaccine: FLUX
Symptoms: Hypoaesthesia
Clinical narrative: Lower right arm is numb.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Hyperhidrosis, Loss of consciousness, Nausea, Presyncope, Vomiting
Clinical narrative: Couple minutes after receiving Tdap, Menactra, and HPV, +vasovagal reaction. +n/v, sweating, brief LOC. Recovered quickly.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Computerised tomogram head, Deafness unilateral, Dizziness, Hearing impaired, Laboratory test
Clinical narrative: Received flu vaccine on a Thursday 10/9/2014 and Sunday 10/12/2014 I noticed my hearing was sounding strange.  When I awaken on Monday morning, the hearing in my right ear was completely gone.  I also experienced extreme vertigo, nausea, vomiting and the room spinning. There was also a lot of noise and ringing in my right ear.  On Tuesday 10/14/2015 morning I went to the ER because the nausea and extreme dizziness did not subside. They drew labs and performed a CT scan of the head and admitted me overnight for further observation.  I was also referred to an ENT for examination.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Tinnitus, Vertigo, Vomiting
Clinical narrative: Received flu vaccine on a Thursday 10/9/2014 and Sunday 10/12/2014 I noticed my hearing was sounding strange.  When I awaken on Monday morning, the hearing in my right ear was completely gone.  I also experienced extreme vertigo, nausea, vomiting and the room spinning. There was also a lot of noise and ringing in my right ear.  On Tuesday 10/14/2015 morning I went to the ER because the nausea and extreme dizziness did not subside. They drew labs and performed a CT scan of the head and admitted me overnight for further observation.  I was also referred to an ENT for examination.
Age: 80.0
Sex: U
Vaccine: FLUX
Symptoms: Injection site discolouration, Injection site pain, X-ray limb
Clinical narrative: Pain at injection spot black and blue at sight. 2 months - Hospital X Ray pain pills administered 10-14-15 AM. Still in pain 12-19-15.
Age: 13.0
Sex: M
Vaccine: FLU3, HPV4
Symptoms: Depressed level of consciousness, Dizziness, Muscle twitching
Clinical narrative: 13 year old child here for vaccines administered flu 0.5 cc (R) deltoid HPV #3 (L) deltoid. C/O dizziness - semiconscious - revived within 30 minutes left clinic with stable VS.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Blood creatine phosphokinase normal, C-reactive protein normal, Full blood count normal, Myalgia, Red blood cell sedimentation rate normal
Clinical narrative: Deltoid pain, prolonged without initial reaction, just musc pain present still 12/22/15, but improved Tx with po ibuprofen US and lab w/u (-).
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Ultrasound scan normal
Clinical narrative: Deltoid pain, prolonged without initial reaction, just musc pain present still 12/22/15, but improved Tx with po ibuprofen US and lab w/u (-).
Age: 74.0
Sex: M
Vaccine: FLU3
Symptoms: Muscular weakness
Clinical narrative: Arm weakness - treatment by ortho physician.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Patient has pain and soreness at site of injection since day of vaccination (44 days). She is going to get X-ray.
Age: 9.0
Sex: F
Vaccine: FLUN4
Symptoms: Cough, Wheezing
Clinical narrative: Pt got FLUMIST vaccine 9-28-15 (while still 9 yrs old). She came in 12-5-15 with a history of cough for 3-4 wks and had wheezing (for the first time). Wheeze onset about 5 weeks after FLUMIST dose.
Age: 1.0
Sex: M
Vaccine: FLU3, MMR, PNC13, VARCEL
Symptoms: Rash generalised, Vaccination complication
Clinical narrative: Mother bought pt to office for a rash that was present over entire body including face and neck. No fever or other symptoms reported. PCP confirmed that rash was consist ant with post-vaccination reaction to one of the live-virus vaccines (MMR/Varicella).
Age: 1.01
Sex: M
Vaccine: FLU3, HEPA, MMRV
Symptoms: Rash maculo-papular
Clinical narrative: 11-30-15 pt. received MMRV vaccine without incident. 12-18-15 pt developed a quickly spreading macular pap non-vesicular non-inflamed diffuse rash with distinct boundaries on torso spreading to extremities. Afebrile.
Age: 59.0
Sex: U
Vaccine: FLU4
Symptoms: Neck mass
Clinical narrative: She complained lump on her left neck after getting Flu shot (FLUARIX Quad) on 12/18/2015.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Diarrhoea, Injection site rash, Mumps, Parotitis, Pyrexia
Clinical narrative: Patient's mother reports 4 year WCC 12/10/15. 12/11/15 Rash at injection site. 12/12/15 Fever, vomiting, diarrhea. 12/13/15 (L) facial swelling, continued fever. 12/14/15 Office visit (L) facial swelling TTP c/w mumps or parotitis OTW well. Advised home care. No school x 5 days and when swelling resolved.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Swelling face, Vomiting
Clinical narrative: Patient's mother reports 4 year WCC 12/10/15. 12/11/15 Rash at injection site. 12/12/15 Fever, vomiting, diarrhea. 12/13/15 (L) facial swelling, continued fever. 12/14/15 Office visit (L) facial swelling TTP c/w mumps or parotitis OTW well. Advised home care. No school x 5 days and when swelling resolved.
Age: 17.0
Sex: F
Vaccine: FLUN4, MENB, MNQ
Symptoms: Erythema, Nodule
Clinical narrative: Golf ball size knot with redness.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Pt called us on 10-5-15 -stating pain in her left arm since getting Flu shot on 9-21-15. We have treated her with ketorolac pills and shots. Also treat her with prednisone and DILAUDID. Pt's better after shoulder injection.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Musculoskeletal pain, Pain
Clinical narrative: Left shoulder ached for over 8 weeks. Could not raise arm without pain.
Age: 1.76
Sex: M
Vaccine: FLUN4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Office form was completed by parent. He wrote child was 2 yrs old. Child is foreign born, DOB was recorded day/month/yr. - Language was a bit of a barrier. Nurse did not double check DOB. Against form prior to administering FLUMIST. Child was 3 mos. under minimum age for FLUMIST. (No adverse reactions reported).
Age: 6.0
Sex: M
Vaccine: FLU4
Symptoms: Anxiety, Confusional state, Heart rate increased, Malaise, Nasopharyngitis
Clinical narrative: Spoke to mom. She is calling to report patient has severe reaction to flu vaccine. Vaccine administered on 12/24 at approx 9:00am. At noon started feeling ill. Mom gave TYLENOL. Approx 4 hrs later patient started shaking, couldn't put words together, didn't know who mom was, increased HR, vomiting. Fever 100.2. Taken to ER and advised likely reaction to flu vaccine. Symptoms of confusion, increased HR and tingling feet continued intermittently for next two days. Currently patient is doing well and back to baseline with exception of mild cold symptoms. He does not remember details of reaction. Activity is good, eating and drinking fluids. Mom and patient are both very anxious about symptoms. Patient will not leave her side for very long. Mom states last year patient vomited after flu vaccine. She is angry that she agreed to vaccine this year.
Age: 6.0
Sex: M
Vaccine: FLU4
Symptoms: Paraesthesia, Pyrexia, Speech disorder, Tremor, Vaccination complication
Clinical narrative: Spoke to mom. She is calling to report patient has severe reaction to flu vaccine. Vaccine administered on 12/24 at approx 9:00am. At noon started feeling ill. Mom gave TYLENOL. Approx 4 hrs later patient started shaking, couldn't put words together, didn't know who mom was, increased HR, vomiting. Fever 100.2. Taken to ER and advised likely reaction to flu vaccine. Symptoms of confusion, increased HR and tingling feet continued intermittently for next two days. Currently patient is doing well and back to baseline with exception of mild cold symptoms. He does not remember details of reaction. Activity is good, eating and drinking fluids. Mom and patient are both very anxious about symptoms. Patient will not leave her side for very long. Mom states last year patient vomited after flu vaccine. She is angry that she agreed to vaccine this year.
Age: 6.0
Sex: M
Vaccine: FLU4
Symptoms: Vomiting
Clinical narrative: Spoke to mom. She is calling to report patient has severe reaction to flu vaccine. Vaccine administered on 12/24 at approx 9:00am. At noon started feeling ill. Mom gave TYLENOL. Approx 4 hrs later patient started shaking, couldn't put words together, didn't know who mom was, increased HR, vomiting. Fever 100.2. Taken to ER and advised likely reaction to flu vaccine. Symptoms of confusion, increased HR and tingling feet continued intermittently for next two days. Currently patient is doing well and back to baseline with exception of mild cold symptoms. He does not remember details of reaction. Activity is good, eating and drinking fluids. Mom and patient are both very anxious about symptoms. Patient will not leave her side for very long. Mom states last year patient vomited after flu vaccine. She is angry that she agreed to vaccine this year.
Age: 54.0
Sex: F
Vaccine: FLU3, HEP, TDAP
Symptoms: Rash, Urticaria
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of hives in a 54-year-old female patient who received BOOSTRIX (batch number YM7J9, expiry date unknown). Co-suspect products included ENGERIX B adult (batch number 24JP3, expiry date unknown) and Influenza vaccine unspecified. On 19th December 2015, the patient received BOOSTRIX .5 ml, ENGERIX B adult 1 ml and influenza vaccine unspecified. On 19th December 2015, 15 min after receiving BOOSTRIX, ENGERIX B adult and Influenza vaccine unspecified, the patient experienced hives and rash. On an unknown date, the outcome of the hives and rash were unknown. It was unknown if the reporter considered the hives and rash to be related to BOOSTRIX, ENGERIX B adult and Influenza vaccine unspecified.
Age: 37.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: Sore and sometimes tingling arm.
Age: 7.0
Sex: F
Vaccine: HEP
Symptoms: Hypoaesthesia, Immediate post-injection reaction, Syncope
Clinical narrative: Patient complained of numbness in arm immediately after vaccination. A few minutes later she fainted.
Age: 10.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper, Arthralgia, Decreased appetite, Flushing, Insomnia
Clinical narrative: Joint pain, stomach ache, loss of appetite, difficulty sleeping, flushed cheeks, malaise.
Age: 10.0
Sex: F
Vaccine: HPV4
Symptoms: Malaise
Clinical narrative: Joint pain, stomach ache, loss of appetite, difficulty sleeping, flushed cheeks, malaise.
Age: 25.0
Sex: M
Vaccine: HPV4
Symptoms: Injected limb mobility decreased, Injection site pain, Pain
Clinical narrative: Since 12/7/15 I have felt a pain in my shoulder from my 3rd Gardasil shot. I thought it would go away until 12/13/15 I felt intense pain where I could barely lift my arm or move it. It was in constant pain in every position. I woke up the next day and the pain had subsided. But now I have limited range of motion. In some directions I feel sharp pain. I did not have this at all before the shot.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Body temperature increased, Erythema, Eye pain, Headache, Injection site erythema
Clinical narrative: Temp to 101, headache and eye pain.  Then vomiting, body pain, redness and swelling at site of vaccine on left arm.  Seen at Urgent Care 12/22.  No treatment.  Seen Wed 12/23 with temp 100.1 incr warmth/redness on left arm same side as vaccine site.  Also swelling, pain, and warmth in RIGHT hand, and more body aches/pain.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Laboratory test normal, Pain, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Temp to 101, headache and eye pain.  Then vomiting, body pain, redness and swelling at site of vaccine on left arm.  Seen at Urgent Care 12/22.  No treatment.  Seen Wed 12/23 with temp 100.1 incr warmth/redness on left arm same side as vaccine site.  Also swelling, pain, and warmth in RIGHT hand, and more body aches/pain.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Vaccination site swelling, Vomiting
Clinical narrative: Temp to 101, headache and eye pain.  Then vomiting, body pain, redness and swelling at site of vaccine on left arm.  Seen at Urgent Care 12/22.  No treatment.  Seen Wed 12/23 with temp 100.1 incr warmth/redness on left arm same side as vaccine site.  Also swelling, pain, and warmth in RIGHT hand, and more body aches/pain.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Immediate post-injection reaction, Syncope
Clinical narrative: Patient had noted reactions from the Polio vaccince at age 8.  Asked about the specific reactions, told she became very dizzy.  Asked questions to rule out any need for possible anaphylaxis, ruling out possible need of needed EPI Pen readiness.  Immediately upon injection, began to get dizzy.  Patient quickly became dizzy to the point of fainting.  At that time, another pharmacist came to assist holding patient upright.  Associate instructed to call 911.  Ambulance arrived and documented previous description of adverse reaction.  Patient transported to Hospital for full evauluation.
Age: 27.0
Sex: M
Vaccine: HEP
Symptoms: Abdominal pain upper, Asthenia, Diarrhoea, Dizziness, Dyspnoea
Clinical narrative: Stomach pains, vomiting multiple times, Diarrhea for 3 days, Fainting, dizziness, trouble breathing. Sleepiness, weakness.
Age: 27.0
Sex: M
Vaccine: HEP
Symptoms: Somnolence, Syncope, Vomiting
Clinical narrative: Stomach pains, vomiting multiple times, Diarrhea for 3 days, Fainting, dizziness, trouble breathing. Sleepiness, weakness.
Age: 19.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Abnormal loss of weight, Arthralgia, Bacterial infection, Deafness, Ear infection
Clinical narrative: Symptoms progressive; taken back to doctor on 11/18/2015 when illness presented didn't pass. Treated for bacterial infection with antibiotics. Returned on 11/26/2015 when new symptoms arose (hearing loss/ear infection). Unintentional weight loss, rash, low grade fevers, headaches, muscle pain and weakness, multiple joint pain, exhaustion. Received 3rd dose of Gardasil on 02/03/2015 followed by worsening of symptoms following immunization on 10/13/2014. Chronic pain, inability to walk without support, neuropathy. Treatment has been unsuccessful to date.
Age: 19.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Fatigue, Gait disturbance, Headache, Muscular weakness, Myalgia
Clinical narrative: Symptoms progressive; taken back to doctor on 11/18/2015 when illness presented didn't pass. Treated for bacterial infection with antibiotics. Returned on 11/26/2015 when new symptoms arose (hearing loss/ear infection). Unintentional weight loss, rash, low grade fevers, headaches, muscle pain and weakness, multiple joint pain, exhaustion. Received 3rd dose of Gardasil on 02/03/2015 followed by worsening of symptoms following immunization on 10/13/2014. Chronic pain, inability to walk without support, neuropathy. Treatment has been unsuccessful to date.
Age: 19.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Neuropathy peripheral, Pain, Pyrexia, Rash, Walking aid user
Clinical narrative: Symptoms progressive; taken back to doctor on 11/18/2015 when illness presented didn't pass. Treated for bacterial infection with antibiotics. Returned on 11/26/2015 when new symptoms arose (hearing loss/ear infection). Unintentional weight loss, rash, low grade fevers, headaches, muscle pain and weakness, multiple joint pain, exhaustion. Received 3rd dose of Gardasil on 02/03/2015 followed by worsening of symptoms following immunization on 10/13/2014. Chronic pain, inability to walk without support, neuropathy. Treatment has been unsuccessful to date.
Age: 11.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site urticaria, Paraesthesia oral, Urticaria
Clinical narrative: Hives began at injection site on right upper arm, and extended across neck and back, then down left arm. Few scattered hives on face. Tingling of lips. Sent to ER next door to clinic where they administered Benadryl and steroids.
Age: 53.0
Sex: M
Vaccine: FLU4
Symptoms: Encephalitis, Laboratory test normal, Lumbar puncture normal, Nuclear magnetic resonance imaging brain abnormal, Seizure
Clinical narrative: Acute onset of frontal lobe encephalitis with seizures within 24 hours of flu vaccination.
Age: 0.18
Sex: M
Vaccine: DTAPIPVHIB, IPV, TDAP
Symptoms: Developmental delay, Repetitive speech, Stereotypy
Clinical narrative: Repetitive behavior, repeat phrases, hand flapping, not hitting milestones for appropriate age.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Breast pain, Dizziness, Hypoaesthesia, Pain
Clinical narrative: Began in the afternoon with soreness down arm, then through the night spread to the hand and upper breast (right). By am the next day unable to grasp item without extreme pain. Numbness, tingling, lightheadedness ensued. Mentioned to 5 other nurses, all had same sx; notified our employee health. Saw physician, he felt possible hit a nerve. Over next couple of days, noted joint pain in hips and legs. Subsided after about day 3-4; however, still have residual thumb pain.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: Began in the afternoon with soreness down arm, then through the night spread to the hand and upper breast (right). By am the next day unable to grasp item without extreme pain. Numbness, tingling, lightheadedness ensued. Mentioned to 5 other nurses, all had same sx; notified our employee health. Saw physician, he felt possible hit a nerve. Over next couple of days, noted joint pain in hips and legs. Subsided after about day 3-4; however, still have residual thumb pain.
Age: 14.0
Sex: F
Vaccine: FLU3
Symptoms: Borrelia test, VIIth nerve paralysis
Clinical narrative: Had Influenza vaccine 12/15/15. Developed Left-sided Bell's Palsy 1 wk later.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site inflammation, Injection site pruritus
Clinical narrative: Patient came in after 2 days saying the injection site was inflamed, red and it itched.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Ongoing pain in (L) arm where vaccine was administered.
Age: 12.0
Sex: F
Vaccine: FLUN4, MNQ, TDAP
Symptoms: Dizziness
Clinical narrative: Pt became lightheaded after vaccines. Resolved after given juice.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Left arm redness, swelling, pain. Treated with KEFLEX and prednisone.
Age: 19.0
Sex: F
Vaccine: FLU3
Symptoms: Loss of consciousness, Syncope
Clinical narrative: Syncope - 1 minute after immunization administered. Immediately regained consciousness.
Age: 2.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Febrile convulsion
Clinical narrative: Patient had febrile seizure and rigors. Went to ER and had a follow up appt in office.
Age: 0.01
Sex: M
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Expired vaccine administered to infant. DPH notified, VAERS form filled out, parents notified. Recommend revaccination of Hep B #1.
Age: 18.0
Sex: M
Vaccine: DTAP, MNQ
Symptoms: Drug administered to patient of inappropriate age, Wrong drug administered
Clinical narrative: Patient was to receive Tdap but instead was given DTaP. Staff in charge notified. CDC was called and we were told patient may have a slightly higher risk of pain at injection site. Vaccine does count and will be valid in place of Tdap. No action required.
Age: 0.3
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Injection site swelling
Clinical narrative: Given 4 month vaccines as per guidelines. Swelling in right thigh 4 hours later.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Aspiration bursa, Bursitis, Injection site reaction
Clinical narrative: Patient claimed to get bursitis at injection site and required draining. Patient now needs 6 weeks of physical therapy.
Age: 57.0
Sex: F
Vaccine: PNC13, TYP
Symptoms: Injection site erythema, Injection site mass, Injection site swelling, Loss of consciousness, Nausea
Clinical narrative: Shortly after injection pt notice red area with a lump at injection site and swelling down to elbow. The next morning she was nauseated, went for a drink of water in her kitchen and passed out. This was witnessed by her husband, an MD. Woke up in a few minutes. No problems since.
Age: 45.0
Sex: F
Vaccine: TDAP
Symptoms: Rash maculo-papular, Rash pruritic
Clinical narrative: Pruritic maculopapular rash on arms, back, abdomen, legs, and chest.
Age: 69.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Nausea, Rash
Clinical narrative: Headache, nausea, rash - face and back.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Patient came into pharmacy with hives all over body. Sent patient to local walk-in clinic where MD prescribed steroid and antihistamine for reaction.
Age: 80.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling upper (L) arm. Treated with doxycycline.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Nausea, Photophobia, Pyrexia, Rash
Clinical narrative: Rash on arm by immunization site. Nausea, fever, headache and light sensitivity.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Injection site nodule, Injection site swelling
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of injection site swelling in a 16-year-old female patient who received BEXSERO. Concurrent medical conditions included penicillin allergy. On 15th December 2015, the patient received BEXSERO .5 ml. In December 2015, less than a week after receiving BEXSERO, the patient experienced injection site swelling. On an unknown date, the outcome of the injection site swelling was unknown. It was unknown if the reporter considered the injection site swelling to be related to BEXSERO. Additional details were received as follows: In December 2015, less than a week (it was unsure whether injection site swelling occurred on same day of vaccination or next day) after receiving BEXSERO the patient experienced severe swelling at the injection site of the size of a baseball (swelled up into a knot) fro about 5 days and was still ongoing at the time of reporting. The patient was allergic to penicillin but did not have any latex allergy. The patient initials, date of birth, vaccine batch number and expiry date of vaccine were unknown. The call was escalated to medical information system.
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Asthma, Hepatitis A antibody negative, Hepatitis B antibody negative
Clinical narrative: This spontaneous report was received from a physician referring to a currently 6 year old male patient. Information about the patient's medical history and concurrent conditions was not provided. On 19-MAY-2009, the patient was vaccinated with his first dose of RECOMBIVAX HB, then on 21-JUL-2009 he received the second dose of the series and on 07-DEC-2009 the third one (administration routes, lot numbers and expiration dates were not provided) in MARRS # 1512USA010638.The patient was also vaccinated with a first dose of VAQTA on 20-DEC-2010 and on 01-DEC-2011 with a second one (administration routes, lot numbers and expiration dates were not provided). No concomitant therapies were reported. On an unspecified date, the patient was tested for both VAQTA and RECOMIVAX HB titers, but they were both negative. The physician also reported that the patient developed asthma on an unknown date, after completion of the series of both vaccines. The outcome of hepatitis v surface antibody negative, hepatitis a antibody negative and asthma was reported as not recovered at the time of this report. The reporter did not provide a causality assessment between the events and therapy with VAQTA and RECOMBIVAX HB. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report was received from a pharmacist referring to a 72 year old female patient. The patient's medical history included hypertension. Concurrent condition was not provided. On 09-DEC-2015, the patient was vaccinated with ZOSTAVAX (lot # L002422, expiration date 23-APR-2016) subcutaneous (dose was not provided). Concomitant medications were not reported. In December 2015, the patient experienced injection site erythema, injection site swelling and injection site warmth. On 14-DEC-2015, the patient went back to the pharmacy for medical attention because the symptoms were still present. The pharmacist also stated that there was no rash present. The patient did not receive any treatment for the adverse events. The outcome of injection site erythema, injection site swelling and injection site warmth was reported as not recovered. The primary reporter did not provide the causality between ZOSTAVAX and injection site erythema, injection site swelling and injection site warmth. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a Licensed Vocational Nurse (LVN) referring to unspecified number of patients. On unknown dates the patients were vaccinated with improperly stored dose of PROQUAD (Merck) (dose and route not reported, lot# L019994, expiration date: 02-DEC-2016). No adverse event. This is one of several reports from the same reporter. Additional information has been requested.