chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: VARZOS
Symptoms: Amyotrophic lateral sclerosis, Death
Clinical narrative: This spontaneous report was received from a physician (a patient's colleague) via company representative and refers to a male patient of unknown age. There was no information about patient's pertinent medical history, concomitant medications, drug reactions or allergies reported. On an unspecified date in approximately 2014 (reported as "approximately 2 years ago"), the patient was vaccinated with ZOSTAVAX refrigerated vial (lot#, expiration date, dose, anatomical location and route of administration were not reported). Directly following the vaccination, in approximately 2014, the patient was diagnosed with the Lou Gehrig's Disease (ALS). On an unknown date (reported as "recently"), the patient passed away. The cause of death was not provided. The outcome of the event of ALS was not reported. The reporting physician thought there might be a correlation between the event of ALS and vaccination with ZOSTAVAX. The relatedness between the patient's death and ZOSTAVAX was not reported. Upon internal review the event of ALS was considered as medically significant. Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Biopsy skin, Breast cancer female, Cancer surgery, Herpes zoster
Clinical narrative: This spontaneous report has been received from a 73 year old female consumer reporting on herself. The patient's pertinent medical history included iodine allergy. On 15-OCT-2007 the patient was vaccinated with ZOSTAVAX 19400 PFU (dose, and lot #, were not provided). Concomitant therapies included anastrozole, unspecified antibiotic and ibuprofen. In August 2015 the patient underwent a breast cancer surgery on her left side (reported as pertinent medical history). Subsequently, it was reported that the experienced an apparent outbreak of shingles; since on 10-JAN-2016 she experienced, back pain and hives on her left side, for that reason on 17-JAN-2016 the patient sought medical attention, at an unspecified medical clinic for the "hives on her left side" that was still present, she was treated with an antiviral and scrape test to test for shingles was done at the site of the lesion. The consumer reported that the results of the scrape test had not come in yet. At the time of the report the outcome of breast cancer was unknown and the outcome of herpes zoster, was reported as recovering. The relatedness between the events and ZOSTAVAX was not reported. Upon internal review the breast cancer was considered medically significant event. Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: This spontaneous report has been received from a 73 year old female consumer reporting on herself. The patient's pertinent medical history included iodine allergy. On 15-OCT-2007 the patient was vaccinated with ZOSTAVAX 19400 PFU (dose, and lot #, were not provided). Concomitant therapies included anastrozole, unspecified antibiotic and ibuprofen. In August 2015 the patient underwent a breast cancer surgery on her left side (reported as pertinent medical history). Subsequently, it was reported that the experienced an apparent outbreak of shingles; since on 10-JAN-2016 she experienced, back pain and hives on her left side, for that reason on 17-JAN-2016 the patient sought medical attention, at an unspecified medical clinic for the "hives on her left side" that was still present, she was treated with an antiviral and scrape test to test for shingles was done at the site of the lesion. The consumer reported that the results of the scrape test had not come in yet. At the time of the report the outcome of breast cancer was unknown and the outcome of herpes zoster, was reported as recovering. The relatedness between the events and ZOSTAVAX was not reported. Upon internal review the breast cancer was considered medically significant event. Additional information has been requested.
Age: 17.0
Sex: U
Vaccine: MMR
Symptoms: Blister, Dehydration, Measles post vaccine, Morbillivirus test positive, Oral disorder
Clinical narrative: This literature marketed report as received from the authors of the published article, refers to a 17 year old patient of unknown gender with reactive airway disease. At the age of 12 months (in approximately 1999) and at the age of 4 years (in approximately 2002), the patient was vaccinated with doses of MMR vaccine (manufacturer unknown) (lot number, expiry date, dose, site and route of administration not reported). On 14-FEB-2015, the patient was seen in an emergency department for evaluation of reactive airway disease. In the waiting room at the same time there were two children who were later confirmed to have measles. The patient began a 5-day course of prednisone (manufacturer unknown) (oral tablet, 50 mg daily); however, symptoms continued, and the patient returned to the emergency department the next day (on 15-FEB-2015) and received methylprednisolone (125 mg, intravenously). The patient had documented receipt of two doses of MMR vaccine (manufacturer unknown), therefore was not administered with intramuscular immune globulin after they had been identified as a person exposed to the two children with measles. On 02-MAR-2015, 16 days after the first emergency department visit, the patient was hospitalized for vomiting and dehydration. The patient was also found to be febrile and to have a confluent popular rash that began on the face and spread to trunk and extremities and had small vesicular oral lesions. Measles was confirmed by laboratory testing (on an unknown day in approximately March 2015), and the patient received supportive treatment with anti-emetics and intravenous fluids. The author concluded that it was not known whether the patient developed immunity to measles in response to the administered doses of MMR vaccine (manufacturer unknown) or whether the patient had an unrecognized immunocompromising condition, but the recent steroid use might have weakened the patient's immune response and rendered the patient susceptible to wild measles strain. The outcome of the measles and vaccination failure was not reported. The author considered vaccination failure and measles to be related to MMR vaccine (manufacturer unknown), since the patient had received 2 doses of MMR vaccine (manufacturer unknown) and did not meet criteria for being severely immunocompromised, but did develop measles after being exposed in the setting of a hospital emergency department to patients with laboratory-confirmed measles. Additional information has been requested.
Age: 17.0
Sex: U
Vaccine: MMR
Symptoms: Pyrexia, Rash, Rash papular, Vaccination failure, Vomiting
Clinical narrative: This literature marketed report as received from the authors of the published article, refers to a 17 year old patient of unknown gender with reactive airway disease. At the age of 12 months (in approximately 1999) and at the age of 4 years (in approximately 2002), the patient was vaccinated with doses of MMR vaccine (manufacturer unknown) (lot number, expiry date, dose, site and route of administration not reported). On 14-FEB-2015, the patient was seen in an emergency department for evaluation of reactive airway disease. In the waiting room at the same time there were two children who were later confirmed to have measles. The patient began a 5-day course of prednisone (manufacturer unknown) (oral tablet, 50 mg daily); however, symptoms continued, and the patient returned to the emergency department the next day (on 15-FEB-2015) and received methylprednisolone (125 mg, intravenously). The patient had documented receipt of two doses of MMR vaccine (manufacturer unknown), therefore was not administered with intramuscular immune globulin after they had been identified as a person exposed to the two children with measles. On 02-MAR-2015, 16 days after the first emergency department visit, the patient was hospitalized for vomiting and dehydration. The patient was also found to be febrile and to have a confluent popular rash that began on the face and spread to trunk and extremities and had small vesicular oral lesions. Measles was confirmed by laboratory testing (on an unknown day in approximately March 2015), and the patient received supportive treatment with anti-emetics and intravenous fluids. The author concluded that it was not known whether the patient developed immunity to measles in response to the administered doses of MMR vaccine (manufacturer unknown) or whether the patient had an unrecognized immunocompromising condition, but the recent steroid use might have weakened the patient's immune response and rendered the patient susceptible to wild measles strain. The outcome of the measles and vaccination failure was not reported. The author considered vaccination failure and measles to be related to MMR vaccine (manufacturer unknown), since the patient had received 2 doses of MMR vaccine (manufacturer unknown) and did not meet criteria for being severely immunocompromised, but did develop measles after being exposed in the setting of a hospital emergency department to patients with laboratory-confirmed measles. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Erythema
Clinical narrative: Left thigh with 2x3 inch area of erythema. Patient given KEFLEX 4ml PO TID for 10 days.
Age: 0.34
Sex: M
Vaccine: DTAPIPV
Symptoms: Drug administered to patient of inappropriate age, Vomiting
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of vomiting in a 4-month-old male patient who received KINRIX (batch number 3N7Y7, expiry date 27th MAY 2017). On 18th JANUARY 2016, the patient received KINRIX .5 ml. On 18th January 2016, less than a day after receiving KINRIX, the patient experienced vomiting and inappropriate age at vaccine administration. On 19th JANUARY 2016, the outcome of the vomiting was recovered/resolved. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown. It was unknown if the reporter considered the vomiting to be related to KINRIX. Additional details provided were as follows: On 18th JANUARY 2016, the patient received a dose of KINRIX vaccine at the age of 4 months, which led to inappropriate age at vaccination. On 18th JANUARY 2016, less than a day after vaccination, the patient experienced vomiting, this resolved in the end of the 19th JANUARY 2016. The reporter wanted safety recommendations.
Age: 3.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: Patient complains of adverse effect of other and unspecified vaccines and biological substances. It began 2 days ago. It is of mild intensity. This is the first episode. The typical duration of an episode is the majority of the day. Aggravating factors include is getting worse since first noticed. Nothing relieves symptoms. Associated symptoms include pain, rash, swelling and at site of vaccine injection left ant thigh. He denies fever.
Age: 24.0
Sex: F
Vaccine: VARCEL
Symptoms: Paraesthesia oral, Pharyngeal oedema, Swollen tongue
Clinical narrative: TONGUE SWELLED UP FELT TINGLY THROAT FELT MORE SWOLLEN FELT THAT 30 MINUTES AFTER INJECTION TOOK 2 BENADRYL AT 4 PM WENT TO ER GIVEN BENADRYL, SOLUMEDROL AND PEPCID SENT HOME 2 HOURS LATER WITH STEROID PRESCRIPTION.
Age: 2.0
Sex: F
Vaccine: HEPA, MMR
Symptoms: Crying, Dyspnoea, Palpitations, Pyrexia
Clinical narrative: Extreme High Fever 105 to 106. Baby on constant Tylenol and Motrin for 2 weeks before fever broke. Racing heart, heavy breathing, and constant crying.
Age: 11.0
Sex: M
Vaccine: FLUN4, MNQ
Symptoms: Fatigue, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient complained of Fatigue, Soreness, redness and swelling at the site the Menactra was injected.
Age: 74.0
Sex: M
Vaccine: PNC13
Symptoms: Infection, Swelling
Clinical narrative: This is a spontaneous report from a non-contactable consumer. This 74-year-old male patient of an unspecified ethnicity received PREVNAR 13, via an unspecified route of administration on an unspecified date at 0.5 ml, single. Medical history included heart problem. Concomitant medications were not reported. The patient got all infected from the shot and he blew up like a balloon on an unspecified date. The patient mentioned that he got pneumonia shot and he got all infected from the shot, he blew up like a balloon and he had to run to the emergency room, he was there for few hours. He stated that they were going to admit him. The patient mentioned that they kept him there for about 4 hours, they put all those medications to kill the infections that he had. He was there for little while, they checked him and they drew like a road map on his arm where he had the infection and the doctor said they would release him and told him that if anything started spreading over that line he would have to come back. The patient mentioned that they told him to follow up as he had to run back to emergency room the follow one day and in meantime they gave him prescription of the medication that he had to take 4 times a day. After he got infection, he had to take whole thing for about 4 to 5 days. He mentioned that he started to get little better and improved. Therapeutic measures were taken as a result of infection. The outcome of the events was unknown. No follow-up attempts possible. No further information expected.
Age: 1.49
Sex: F
Vaccine: DTAP, IPV
Symptoms: Dyspnoea, Laboratory test, Pyrexia
Clinical narrative: Dangerous High fever 105 and 106. Heavy breathing and difficulty breathing.
Age: 9.0
Sex: M
Vaccine: TDAP
Symptoms: Erythema, Peripheral swelling, Tenderness
Clinical narrative: Arm is red, swollen, and sensitive to the touch. No fever.
Age: 54.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Burning sensation, Eye pruritus, Hypersensitivity, Urticaria
Clinical narrative: Approximately 10 to 15 minutes following administration of immunizations (listed below) patient reported having hives on arms and chest and itchy eyes, and that her left arm felt like it was "burning" similar to the feeling of a sunburn. Patient stated she had similar reaction (hives from head to toe) after receiving flu shot last year. Pt denied trouble breathing or SOB. Advised pt to follow up with doctor as soon as possible for possible steroid or other treatment for allergic rxn. Spoke with pt on Sun. 12/20/15 pt reports some relief of symptoms w/2 tabs of BENADRYL approximately 30 minutes after rxn started.
Sex: M
Vaccine: PPV
Symptoms: Injection site rash
Clinical narrative: Information was received from a third party claims management company who represented a pharmacy. A male of unknown age received PNEUMOVAX 23 (Lot # L012215, Exp. 13JAN2017) on 05-OCT-2015 and shortly after developed a rash at the injection site. The pharmacy quarantined the vial. The outcome of the rash at the injection site was unknown. Additional information has been requested.
Age: 27.0
Sex: F
Vaccine: VARCEL
Symptoms: Chest discomfort, Oropharyngeal pain, Pruritus, Urticaria
Clinical narrative: Sore throat; itchy hives and tightness in chest. Referred to PCP.
Age: 1.3
Sex: F
Vaccine: DTAPIPVHIB, HEPA, VARCEL
Symptoms: Blister, Erythema, Papule, Rash, Scab
Clinical narrative: Varicella vaccine given 1/18/16, patient presented w/rapidly evolving rash on 1/14/16 - erythematous papules with some central vesicles, some central scabbing to circumoral, legs, arms, and torso. Given acyclovir, Calamine lotion and Aveeno baths. Rash still present but vastly improved on 1/18/16.
Age: 1.53
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Febrile convulsion, Pyrexia, Respiratory syncytial virus test positive
Clinical narrative: PENTACEL and PCV13 at 1400 1/21/16 fever onset 0530 1/22/16 called 911. Take to ER. Clinic notes, ER Report and RSV result included. Febrile seizure.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Extra dose administered, Gait disturbance, Photosensitivity reaction, Seizure
Clinical narrative: This case was reported by a physician via other manufacturer and described the occurrence of seizure in a 16-year-old female patient who received MENVEO (batch number M14072, expiry date 30th November 2015). Co-suspect products included Meningococcal B vaccine (batch number L13514, expiry date 31st July 2016). Previously administered products included MENVEO (1st dose received on 3rd June 2011). On 4th September 2015, the patient received the 2nd dose of MENVEO (intramuscular) .5 ml and the 1st dose of Meningococcal B vaccine (intramuscular) .5 ml. On 4th September 2015, less than a day after receiving MENVEO, the patient experienced seizure (serious criteria hospitalization and GSK medically significant), photosensitivity, walking difficulty and extra dose administered. Meningococcal B vaccine was discontinued. On an unknown date, the outcome of the seizure, photosensitivity and walking difficulty were recovering/resolving and the outcome of the extra dose administered was unknown. It was unknown if the reporter considered the seizure, photosensitivity and walking difficulty to be related to MENVEO. Additional details were provided as follows: The reporter preferred not to answer the medical history details of the patient. On 3rd June 2011, the patient received the 1st dose of MENVEO vaccine. On 4th September 2015, at 12.26 pm, the patient again received a dose of MENVEO vaccine in the left deltoid, which led to an extra dose administered. On the same day, the patient also received TRUMENBA in the right deltoid intramuscularly. The patient experienced psycho seizures, photosensitivity and she was not able to walk very well at the time of reporting. On 5th September 2015 to 15th September 2015, the patient was hospitalized for duration of 10 days. The patient did not experience any illness at the time of vaccination. The patient was not deceased. The reporter considered the psycho seizure, photosensitivity and walking difficulty to be related to TRUMENBA.
Age: 16.0
Sex: F
Vaccine: HPV4, MENB
Symptoms: Feeling hot, Hyperhidrosis, Nausea, Pharyngitis, Pyrexia
Clinical narrative: 5 min after the injection pt began to feel very warm, became diaphoretic, and nauseous. Pt advised to lay down and a cool compress was applied to her forehead. Pt was given a freezie pop and she began to feel better within minutes. Pt stayed in office for another 15 min. Pushed fluids when pt got home. That night pt dev a fever. Pt was seen in office 1/21/16 dx with sinusitis and pharyngitis and placed on abx.
Age: 16.0
Sex: F
Vaccine: HPV4, MENB
Symptoms: Sinusitis, Streptococcus test negative
Clinical narrative: 5 min after the injection pt began to feel very warm, became diaphoretic, and nauseous. Pt advised to lay down and a cool compress was applied to her forehead. Pt was given a freezie pop and she began to feel better within minutes. Pt stayed in office for another 15 min. Pushed fluids when pt got home. That night pt dev a fever. Pt was seen in office 1/21/16 dx with sinusitis and pharyngitis and placed on abx.
Age: 0.17
Sex: M
Vaccine: HEPA, IPV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Hepatitis A vaccine was inadvertently given. No side effects/adverse event reported.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Blood glucose increased, Crying, Hypotonia
Clinical narrative: After immunization period of constant crying then deep sleep, hypotonia.
Age: 3.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Urticarial rash face only, no SOB, no wheezing. Diphenhydramine 12.5mg/5ml 5 ml PO given.
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Seizure, Tonic clonic movements, Urinary incontinence
Clinical narrative: Seizure with loss of bladder function as well as Rt sided tonic clonic behaviors lasting 90-120 seconds in duration. Approximately 30 sec following GARDASIL inj.
Age: 28.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site inflammation, Injection site warmth
Clinical narrative: Varicella vaccine #1 given in (R) arm SQ. Now red, warm inflamed area.
Sex: M
Vaccine: HEP
Symptoms: Cyanosis, Dyspnoea, Gastrointestinal disorder, Torticollis, Vomiting projectile
Clinical narrative: Projectile vomiting began occurring the week of June 13th 2011.  He could not keep food down and would projectile vomit and would turn blue.  An ambulance was called because the child was struggling to breath.
Age: 1.01
Sex: F
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Urticaria
Clinical narrative: URTICARIA.
Age: 0.24
Sex: F
Vaccine: PNC13, RV1
Symptoms: Dark circles under eyes, Injection site erythema, Injection site induration, Injection site irritation, Injection site swelling
Clinical narrative: Irritated, Red, Hard, Swollen Injection Site - for 10+ days (less than 2 weeks); Disrupted Sleep - suddenly staying up for hours longer than before shot and not sleeping as long (each period and total time), irritable from less sleep and significant 'black circles' under eyes - ongoing.
Age: 0.24
Sex: F
Vaccine: PNC13, RV1
Symptoms: Insomnia, Irritability, Sleep disorder
Clinical narrative: Irritated, Red, Hard, Swollen Injection Site - for 10+ days (less than 2 weeks); Disrupted Sleep - suddenly staying up for hours longer than before shot and not sleeping as long (each period and total time), irritable from less sleep and significant 'black circles' under eyes - ongoing.
Age: 25.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Injection site vesicles
Clinical narrative: Patient experience swelling and blistering around injection site.
Age: 12.0
Sex: F
Vaccine: HPVX
Symptoms: Abdominal pain upper, Acne, Affect lability, Anaemia, Anxiety
Clinical narrative: Insomnia, anxiety, paranoia, (GABA) seizures, tics, food intolerance (gluten free, clean diet, no glutamates) PANDAS/PANS (raw camel milk, frankincense, oregano oil, garlic, and lemons) chronic fatigue, legs would suddenly give out and she would fall, acne, headaches, stomach aches, dizziness, regression, anemia, mood swings, emotional lability, cognitive decline, brain inflammation. (magnesium, lithium, adrenal/kidney/liver support). It began with anxiety and insomnia after second shot (04/10/2014), and that seemed to have a domino effect and all other aspects of health declined with time. Then the school teachers and nurse recommended looking into the severe staring spells she was having by going to a neurologist and seeing if it was petite mal seizures.
Age: 12.0
Sex: F
Vaccine: HPVX
Symptoms: Cognitive disorder, Dizziness, Fall, Fatigue, Food intolerance
Clinical narrative: Insomnia, anxiety, paranoia, (GABA) seizures, tics, food intolerance (gluten free, clean diet, no glutamates) PANDAS/PANS (raw camel milk, frankincense, oregano oil, garlic, and lemons) chronic fatigue, legs would suddenly give out and she would fall, acne, headaches, stomach aches, dizziness, regression, anemia, mood swings, emotional lability, cognitive decline, brain inflammation. (magnesium, lithium, adrenal/kidney/liver support). It began with anxiety and insomnia after second shot (04/10/2014), and that seemed to have a domino effect and all other aspects of health declined with time. Then the school teachers and nurse recommended looking into the severe staring spells she was having by going to a neurologist and seeing if it was petite mal seizures.
Age: 12.0
Sex: F
Vaccine: HPVX
Symptoms: General physical health deterioration, Headache, Insomnia, Mood swings, Muscular weakness
Clinical narrative: Insomnia, anxiety, paranoia, (GABA) seizures, tics, food intolerance (gluten free, clean diet, no glutamates) PANDAS/PANS (raw camel milk, frankincense, oregano oil, garlic, and lemons) chronic fatigue, legs would suddenly give out and she would fall, acne, headaches, stomach aches, dizziness, regression, anemia, mood swings, emotional lability, cognitive decline, brain inflammation. (magnesium, lithium, adrenal/kidney/liver support). It began with anxiety and insomnia after second shot (04/10/2014), and that seemed to have a domino effect and all other aspects of health declined with time. Then the school teachers and nurse recommended looking into the severe staring spells she was having by going to a neurologist and seeing if it was petite mal seizures.
Age: 12.0
Sex: F
Vaccine: HPVX
Symptoms: Noninfective encephalitis, Paediatric autoimmune neuropsychiatric disorders associated with streptococcal infection, Paranoia, Regressive behaviour, Seizure
Clinical narrative: Insomnia, anxiety, paranoia, (GABA) seizures, tics, food intolerance (gluten free, clean diet, no glutamates) PANDAS/PANS (raw camel milk, frankincense, oregano oil, garlic, and lemons) chronic fatigue, legs would suddenly give out and she would fall, acne, headaches, stomach aches, dizziness, regression, anemia, mood swings, emotional lability, cognitive decline, brain inflammation. (magnesium, lithium, adrenal/kidney/liver support). It began with anxiety and insomnia after second shot (04/10/2014), and that seemed to have a domino effect and all other aspects of health declined with time. Then the school teachers and nurse recommended looking into the severe staring spells she was having by going to a neurologist and seeing if it was petite mal seizures.
Age: 12.0
Sex: F
Vaccine: HPVX
Symptoms: Staring, Tic
Clinical narrative: Insomnia, anxiety, paranoia, (GABA) seizures, tics, food intolerance (gluten free, clean diet, no glutamates) PANDAS/PANS (raw camel milk, frankincense, oregano oil, garlic, and lemons) chronic fatigue, legs would suddenly give out and she would fall, acne, headaches, stomach aches, dizziness, regression, anemia, mood swings, emotional lability, cognitive decline, brain inflammation. (magnesium, lithium, adrenal/kidney/liver support). It began with anxiety and insomnia after second shot (04/10/2014), and that seemed to have a domino effect and all other aspects of health declined with time. Then the school teachers and nurse recommended looking into the severe staring spells she was having by going to a neurologist and seeing if it was petite mal seizures.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Rash generalised, Tremor
Clinical narrative: 12 hours after receiving vaccine, pt got a total body rash.  A little while later she experienced uncontrolled shaking.  Patient went to the Emergency room and was prescribed steroids for her rash.
Age: 89.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pruritus, Vaccination site pain
Clinical narrative: Patient went to doctor on 01/22/16 and said she has itching and pain at the site of vaccine administration even after 12 days.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Induration, Pain, Pruritus, Rash erythematous
Clinical narrative: Red Rash, itchy, felt hard, area by elbow painful for 5 days plus. Rash started receding on day 4.
Age: 39.0
Sex: M
Vaccine: FLU4, VARCEL
Symptoms: Arthralgia, Fatigue, Headache, Injection site infection, Injection site oedema
Clinical narrative: On or about 12/20 -23 he developed headache, fatigue, and arthralgias. Symptoms persisted and he did not feel well. On 12/26 he developed a slight fever and a vesicular rash on his extremities, with one lesion on his face and a few on his trunk. Total number of lesions was less than 20. He went to a local urgent care clinic and was diagnosed with chicken pox and a secondary infection to the injection site. He was treated with high dose acyclovir and cephalexin and feels much better at this time. He has one more day of antibiotics to take. He has a few small scabbed skin lesions and some mild edema at the injection site, but overall feels fine.
Age: 39.0
Sex: M
Vaccine: FLU4, VARCEL
Symptoms: Malaise, Pyrexia, Rash vesicular, Scab, Skin lesion
Clinical narrative: On or about 12/20 -23 he developed headache, fatigue, and arthralgias. Symptoms persisted and he did not feel well. On 12/26 he developed a slight fever and a vesicular rash on his extremities, with one lesion on his face and a few on his trunk. Total number of lesions was less than 20. He went to a local urgent care clinic and was diagnosed with chicken pox and a secondary infection to the injection site. He was treated with high dose acyclovir and cephalexin and feels much better at this time. He has one more day of antibiotics to take. He has a few small scabbed skin lesions and some mild edema at the injection site, but overall feels fine.
Age: 39.0
Sex: M
Vaccine: FLU4, VARCEL
Symptoms: Varicella post vaccine, Varicella virus test
Clinical narrative: On or about 12/20 -23 he developed headache, fatigue, and arthralgias. Symptoms persisted and he did not feel well. On 12/26 he developed a slight fever and a vesicular rash on his extremities, with one lesion on his face and a few on his trunk. Total number of lesions was less than 20. He went to a local urgent care clinic and was diagnosed with chicken pox and a secondary infection to the injection site. He was treated with high dose acyclovir and cephalexin and feels much better at this time. He has one more day of antibiotics to take. He has a few small scabbed skin lesions and some mild edema at the injection site, but overall feels fine.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Erythema, Local swelling, Pyrexia, Rash erythematous
Clinical narrative: 4cm x 2cm raised red area swollen lumpy achy slight fever until about 1/20/16 then that area fades and red rash around it which grows to the surrounding area left arm about 20 cm...urgent care fx with cellulitis and began doxycline huckster 100mg cap...helping and healing in process.
Age: 0.25
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Enema administration, Intussusception, Ultrasound abdomen
Clinical narrative: INTUSSUSCEPTION.
Age: 11.0
Sex: F
Vaccine: DTAP, MEN
Symptoms: Asthenia, Headache, Hyperhidrosis, Nausea, Palpitations
Clinical narrative: Heart racing, sweating, nausea, weakness, headache, hives.
Age: 11.0
Sex: F
Vaccine: DTAP, MEN
Symptoms: Rash generalised, Urticaria
Clinical narrative: Heart racing, sweating, nausea, weakness, headache, hives.
Age: 0.36
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Autism, Body temperature increased, Developmental delay, Electroencephalogram, Neurological examination
Clinical narrative: Patient had a seizure within two our of his TDaP vaccine. He has had more than 3 dozen seizures since this time. He was also diagnosed with Autism and major developmental delays.
Age: 0.36
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Seizure
Clinical narrative: Patient had a seizure within two our of his TDaP vaccine. He has had more than 3 dozen seizures since this time. He was also diagnosed with Autism and major developmental delays.
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Pruritus, Rash macular
Clinical narrative: Patient reported itching at 6:00PM then redness (red blotches) at approx 8:30PM. Patient called pharmacy at 9:00PM and used diphenhydramine to treat. Itching returned occasionally, but resolved (all symptoms) after two days.
Age: 1.3
Sex: F
Vaccine: MMRV
Symptoms: Varicella post vaccine, Viral test
Clinical narrative: (+) varicella zoster 1 1/2 yr post immunization.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema, Injection site macule
Clinical narrative: 8x7 cm very faint pinkish macule distal and lateral to actual injection site. Area was more near mid upper inner extremity rather than deltoid area.
Age: 17.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Dizziness, Hyperhidrosis
Clinical narrative: 1:05 pm pt got light headed and sweaty after leaving the office after getting a MCV4 vaccine and a Tdap vaccine.
Age: 60.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Erythema, Inflammation, Pruritus, Skin warm, Swelling
Clinical narrative: Pt noticed itching evening of 1/19. The next morning swelling and red and itching. Swelled to a 3" x 3" area inflamed and hot, red. Pt started taking antihistamine and it is not subsiding.
Sex: F
Vaccine: MMR
Symptoms: Pyrexia
Clinical narrative: This spontaneous report was received from an epidemiologist who was also the patient's mother and refers to a female child patient (reported as the patient had "about 9 or 10 years old"). The patient's medical history included drug hypersensitivity (fever and nausea) following administration of unspecified vaccine (therapy unspecified) (MARRS case 1601USA006994). On an unknown date, the patient was vaccinated with MMR (manufacturer unknown) (lot number, expiration date, dose and route of administration were not reported). There was no concomitant medication reported. On an unknown date, following administration of the MMR (manufacturer unknown), the patient experienced pyrexia (result and units were not reported). The patient did not seek medical attention. At the reporting time, the outcome of pyrexia was recovered on an unspecified date. This is one of several reports from the same patient. Additional information has been requested.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to an unspecified patient of unknown age and gender. Information about the patient's medical history and concurrent conditions was not provided. On 07-JAN-2016, the patient was vaccinated with improperly stored doses of (Oka/Merck) VARIVAX lot # L024252, 30-JUN-2017 and M-M-R II rHa, lot #: L024267, expiration date: 01-JUL-2017 (administration routes were not provided). No concomitant therapies were reported, neither was any adverse effect. It was unknown if the patient sought medical attention. No product quality complaint was involved. This is one of two reports from the same reporter. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Injection site rash
Clinical narrative: Information was received from a third party claims management company who represented a pharmacy. A female of unknown age received PNEUMOVAX 23 (Lot # L012215, Exp. 13JAN2017) on 05-OCT-2015 and shortly after developed a rash at the injection site. The pharmacy quarantined the vial. The outcome of the rash at the injection site was unknown. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Erythema, Urticaria
Clinical narrative: At first I had hives and they were raised and red.  Slowly, they expanded in size and flattened, then faded away.  Mostly on the arm I had the shot on. Not taking chances on the second or third dose.  Was dizzy for a little bit too, though this could just be overreaction.
Age: 3.0
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Swelling, redness and tender to the touch of the area (arm).
Age: 6.0
Sex: M
Vaccine: FLUN4
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Vomit and diarrhea. 8 hours after vaccine given.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Axillary pain, Hypoaesthesia, Injection site pain, Pain, Pain in extremity
Clinical narrative: After receiving the flu shot required by my employer, administered at an employee clinic site, I began experiencing pain in my left shoulder and arm, with radiating pain to my hand and fingers. There has been a constant ache located in my left deltoid and mid arm. I experience shooting pain down my arm, aching pain under my arm, and sometimes numbness and tingling throughout my arm and fingers. There is pain behind my shoulder. It hurts to use my left arm and when I do, it increases the pain.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Paraesthesia
Clinical narrative: After receiving the flu shot required by my employer, administered at an employee clinic site, I began experiencing pain in my left shoulder and arm, with radiating pain to my hand and fingers. There has been a constant ache located in my left deltoid and mid arm. I experience shooting pain down my arm, aching pain under my arm, and sometimes numbness and tingling throughout my arm and fingers. There is pain behind my shoulder. It hurts to use my left arm and when I do, it increases the pain.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Back pain, Dysstasia, Gait disturbance, Guillain-Barre syndrome, Impaired work ability
Clinical narrative: (02/16/2015) Back and leg pain especially on the left side. Foot pain when walking.  Lower left side back pain. (02/19/2015) Hard to walk and stand upright. PCP prescribed oral steroids. Unable to go to work. (02/25/2015) Pain progressed to inability to walk without assistance and total inability to use legs. Went to ER and was admitted.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: (02/16/2015) Back and leg pain especially on the left side. Foot pain when walking.  Lower left side back pain. (02/19/2015) Hard to walk and stand upright. PCP prescribed oral steroids. Unable to go to work. (02/25/2015) Pain progressed to inability to walk without assistance and total inability to use legs. Went to ER and was admitted.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Biopsy skin, Psoriasis
Clinical narrative: Start of over-whole-body psoriasis attack.
Age: 16.0
Sex: M
Vaccine: HEPA, HPVX, IPV, UNK, HEPA, HPV4, IPV, MNQ
Symptoms: Abdominal pain, Abdominal pain upper, Arthralgia, Blood pressure decreased, Blood test
Clinical narrative: Light-headed and fainting, racing heartrate, drop in blood pressure, severe head pressure, abdominal pain, muscle and joint pain. Stomach aches and pains, vertigo, tightness in chest.
Age: 16.0
Sex: M
Vaccine: HEPA, HPVX, IPV, UNK, HEPA, HPV4, IPV, MNQ
Symptoms: Cardiac stress test, Chest discomfort, Computerised tomogram, Dizziness, Head discomfort
Clinical narrative: Light-headed and fainting, racing heartrate, drop in blood pressure, severe head pressure, abdominal pain, muscle and joint pain. Stomach aches and pains, vertigo, tightness in chest.
Age: 16.0
Sex: M
Vaccine: HEPA, HPVX, IPV, UNK, HEPA, HPV4, IPV, MNQ
Symptoms: Myalgia, Nuclear magnetic resonance imaging, Palpitations, Syncope, Ultrasound scan
Clinical narrative: Light-headed and fainting, racing heartrate, drop in blood pressure, severe head pressure, abdominal pain, muscle and joint pain. Stomach aches and pains, vertigo, tightness in chest.
Age: 16.0
Sex: M
Vaccine: HEPA, HPVX, IPV, UNK, HEPA, HPV4, IPV, MNQ
Symptoms: Urine analysis, Vertigo, X-ray
Clinical narrative: Light-headed and fainting, racing heartrate, drop in blood pressure, severe head pressure, abdominal pain, muscle and joint pain. Stomach aches and pains, vertigo, tightness in chest.
Age: 16.0
Sex: M
Vaccine: HEPA, HPVX, IPV, UNK, HEPA, HPV4, IPV, MNQ
Symptoms: Cardiac stress test normal, Chest pain, Computerised tomogram head normal, Dizziness, Full blood count normal
Clinical narrative: Light-headed and fainting, racing heartrate, drop in blood pressure, severe head pressure, abdominal pain, muscle and joint pain. Stomach aches and pains, vertigo, tightness in chest.
Age: 16.0
Sex: M
Vaccine: HEPA, HPVX, IPV, UNK, HEPA, HPV4, IPV, MNQ
Symptoms: Headache, Laboratory test normal, Nausea, Presyncope, Syncope
Clinical narrative: Light-headed and fainting, racing heartrate, drop in blood pressure, severe head pressure, abdominal pain, muscle and joint pain. Stomach aches and pains, vertigo, tightness in chest.
Age: 16.0
Sex: M
Vaccine: HEPA, HPVX, IPV, UNK, HEPA, HPV4, IPV, MNQ
Symptoms: Thyroid function test normal, Ultrasound abdomen normal, Weight decreased
Clinical narrative: Light-headed and fainting, racing heartrate, drop in blood pressure, severe head pressure, abdominal pain, muscle and joint pain. Stomach aches and pains, vertigo, tightness in chest.
Age: 87.0
Sex: F
Vaccine: PNC13
Symptoms: Asthenia, Chills, Cough, Headache, Malaise
Clinical narrative: Felt sick.  Didn't feel like eating.  Went to bed with fever and chills.  Had fever and chills all night.  Felt sick for days.  Had a headache and felt weak.  Developed a cough.
Age: 87.0
Sex: F
Vaccine: PNC13
Symptoms: Pyrexia
Clinical narrative: Felt sick.  Didn't feel like eating.  Went to bed with fever and chills.  Had fever and chills all night.  Felt sick for days.  Had a headache and felt weak.  Developed a cough.
Age: 63.0
Sex: M
Vaccine: MMR
Symptoms: Antibody test negative, Ataxia, CSF immunoglobulin increased, CSF oligoclonal band present, CSF protein increased
Clinical narrative: Numbness in left hand and arm in C4-5-6 distribution with muscle fasciculations followed by temperature changes on right side of body, ataxia, and lower extremity weakness.  Intermittent severe left-sided muscle cramping.
Age: 63.0
Sex: M
Vaccine: MMR
Symptoms: CSF white blood cell count increased, Central nervous system lesion, Feeling of body temperature change, Hypoaesthesia, Muscle contractions involuntary
Clinical narrative: Numbness in left hand and arm in C4-5-6 distribution with muscle fasciculations followed by temperature changes on right side of body, ataxia, and lower extremity weakness.  Intermittent severe left-sided muscle cramping.
Age: 63.0
Sex: M
Vaccine: MMR
Symptoms: Muscle spasms, Muscular weakness, Nuclear magnetic resonance imaging spinal abnormal, Scan with contrast, Spinal cord compression
Clinical narrative: Numbness in left hand and arm in C4-5-6 distribution with muscle fasciculations followed by temperature changes on right side of body, ataxia, and lower extremity weakness.  Intermittent severe left-sided muscle cramping.
Age: 63.0
Sex: M
Vaccine: MMR
Symptoms: Spinal cord oedema
Clinical narrative: Numbness in left hand and arm in C4-5-6 distribution with muscle fasciculations followed by temperature changes on right side of body, ataxia, and lower extremity weakness.  Intermittent severe left-sided muscle cramping.
Age: 49.0
Sex: F
Vaccine: FLUX
Symptoms: Bursitis, Joint crepitation, Pain in extremity, Periarthritis, Tendon rupture
Clinical narrative: Arm has a dull, aching, annoying pain that I can't describe. This eventually resulted in my arm cracking and in excruciating pain during the day and especially at night when sleeping.
Age: 12.0
Sex: F
Vaccine: FLU3
Symptoms: Flushing
Clinical narrative: Flushing to face, hands and lower arms bilat.
Age: 58.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site pain
Clinical narrative: Injection site pain.
Age: 1.01
Sex: M
Vaccine: FLU4, HEPA, MMR, VARCEL
Symptoms: Febrile convulsion, Status epilepticus
Clinical narrative: Multiple seizures (complex febrile seizure, status epilepticus). Required 4 doses of Ativan and 1 dose of fosphenytoin to stop the longest seizure (> 20 min).
Age: 1.0
Sex: M
Vaccine: FLUX, HEPA, MMR, VARCEL
Symptoms: Injection site erythema, Injection site reaction, Urticaria
Clinical narrative: Raised red welt, about the size of a nickel, near the injection site on right thigh.
Age: 17.0
Sex: M
Vaccine: FLU3
Symptoms: Electrocardiogram, Loss of consciousness
Clinical narrative: Patient received shot then passed out. EMS came checked blood pressure, oxygen, and heart.
Age: 60.0
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a certified Medical Assistant via company representative regarding a 60 year old female patient. There was no information about concurrent condition and historical medication. On 28-DEC-2015, the patient who was intended to receive ZOSTAVAX was inadvertently administered vaccinated with VARIVAX (Merck) (wrong drug administered). No concomitant medication was reported. No adverse event was reported. The outcome of the event was unknown. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site induration, Injection site mass
Clinical narrative: This spontaneous report was received from a pharmacist regarding a patient of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date the patient was vaccinated with ZOSTAVAX. No concomitant medication was reported. On an unknown date the patient developed  a hard lump at the injection site. Patient contacted pharmacist to seek medical attention. The outcome of developed a hard lump at the injection site was unknown. Causality between developed a hard lump at the injection site and ZOSTAVAX was unknown. Additional information has been requested.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Post herpetic neuralgia, Rash
Clinical narrative: This spontaneous report as received from a pharmacist (also reported as physician) via a company representative refers to a 76 year old female patient. Concurrent conditions and medical history of the patient were not provided. On an unknown date in September-2015 the patient was vaccinated with ZOSTAVAX, of dose 0.65 ml, subcutaneously (lot# not reported). Concomitant medication was not specified by the reporter. On an unknown day in September-2015 the patient experienced post herpetic neuralgia (PHN), pain and significant rash. The patient sought for medical attention (unspecified). The outcome of post herpetic neuralgia was unknown. The event rash improved but the patient was still experiencing pain, according to the Pharmacist. No other information was provided. Causality statement was not provided by the reporter. No product quality complaint (PQC) was filed. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. The patient's current conditions and medical history were not provided. On 18-JAN-2016 the patient was inadvertently administered with an expired dose of M-M-R II (strength, dose, route, therapy type and indication not provided) of lot # J016234, expiration date: 19-DEC-2015. Concomitant medication was not mentioned. No adverse effects were reported. No additional information provided. Product quality complaint (PQC) was not involved. Additional information has been requested.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Post herpetic neuralgia, Rash
Clinical narrative: This spontaneous report as received from a pharmacist (also reported as physician) via a company representative refers to a 78 year old male patient. Concurrent conditions and medical history of the patient were not provided. On 31-JUL-2012 the patient was vaccinated with ZOSTAVAX vial, of dose 0.65 ml, subcutaneously (lot# not reported). Concomitant medication was not specified by the reporter. On 04-NOV-2015, 1192 days after onset of therapy the patient experienced post herpetic neuralgia (PHN), pain and significant rash. The patient sought for medical attention (unspecified). The outcome of post herpetic neuralgia was unknown. The outcome of rash was resolved, but the outcome of pain was not resolved, according to the Pharmacist. Causality statement was not provided by the reporter. No product quality complaint (PQC) was filed. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 18-JAN-2016 the patient was vaccinated with an expired dose of PROQUAD (Merck) of lot # K009473 and dose 0.5 ml, subcutaneously (indication was not reported). The expiry date of the particular lot of PROQUAD (Merck) was given as 03-JAN-2016. No adverse effects were reported. No further information was provided. Product quality complaint (PQC) was not involved. Additional information has been requested.
Age: 52.0
Sex: F
Vaccine: FLUX
Symptoms: Injected limb mobility decreased, Injection site pain, Sleep disorder
Clinical narrative: Pain in left upper arm by injection site.  Limited movement without severe pain.  Trouble sleeping because of pain.  Getting worse.  Visited with Dr. possible nerve damage.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLUN4, MMRV
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: 9*9 AREA REDNESS/TENDER/WARM (R)THIGH.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Deafness unilateral
Clinical narrative: Complete loss of hearing in left ear.  Saw PA at 10:30 that a.m. who sent me to Specialist at 1:30 same day who initiated Prednisone treatment 9-day course.
Age: 0.5
Sex: F
Vaccine: DTAP
Symptoms: Immunodeficiency
Clinical narrative: Immune deficiency.