chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Erythema, Herpes zoster, Skin irritation
Clinical narrative: This spontaneous report as received from a 61 year old female patient with hypothyroidism and no drug reactions or allergies refers to herself. No information regarding the patient's medical history was provided. On an unknown date in approximately August 2015 (reported as "some time in August"), the patient was vaccinated with a dose of ZOSTAVAX, subcutaneously, (dose, injection site, lot number and expiration date were not reported). The patient's concomitant therapies included SYNTHROID. On approximately 18-DEC-2015 (date estimated based on "about 4 days ago"), the patient began to experience redness and irritation with blisters that she thought was sun poisoning. The patient sought medical attention via visiting a local clinic where the doctor confirmed it was actually a severe case of shingles. No laboratory diagnostic studies were performed. The patient was given acyclovir 800 mg and an unspecified corticosteroid cream for the treatment of the event. At the time of the report, the patient did not recover from the event. The relatedness between a severe case of shingles and ZOSTAVAX was not reported. Additional information is not expected as no contact details to healthcare professional were provided.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to two unspecified patients of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patients were vaccinated with improperly stored ROTATEQ oral (lot# K022993, expiry date: 20-JUL-2016) (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to multiple patients of unknown age and gender. No concomitant medications were reported. No medical history was provided. On unknown dates, multiple unspecified patients were vaccinated with improperly stored doses of PROQUAD (dosage schedule was not provided) (lot# L027634, expiration date: 21-JAN-2017; lot# L019994, expiration date: 02-DEC-2016). No adverse effects were reported. No PQC (product quality complaint) was involved. This is one of several reports from the same reporter. Additional information has been requested.
Age: 2.0
Sex: F
Vaccine: IPV, MMR
Symptoms: Febrile convulsion
Clinical narrative: Per mom had a febrile seizure.
Age: 11.0
Sex: F
Vaccine: HEPA, MENB, TDAP
Symptoms: Injection site erythema, Pain, Pruritus
Clinical narrative: Case number PHHY2015US116427, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 559297) website on 10 Sep 2015. This report refers to a 11-year-old female patient. She was vaccinated with BEXSERO (batch number: not reported) intramuscularly in the left arm on 18 Dec 2014. On the same date, she also received INFANRIX (other manufacturer, batch number: 5DM3Y) and HAVRIX (other manufacturer, batch number: G499B), intramuscularly in the right arm. On 19 Dec 2014, she experienced erythema at site approximately 3 inches in diameter. She also experienced itching and pain to touch. The patient used hot and cold compress. It was reported that patient was seen by the provider on 22 Dec 2014 at 9:57 AM and BENADRYL 12.5mg/ml was prescribed. The outcome of the events was unknown. The events reported as non-serious. The causality of the events was not reported.
Age: 19.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Erythema, Pain, Swelling, Tenderness
Clinical narrative: Case number PHHY2015US123998, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 573752) website on 05 Oct 2015. This report refers to a 19 year old female patient. Medical history and concomitant medication were not provided. The patient was vaccinated with BEXSERO (batch number: 146101) intramuscularly, into the left arm on 10 Apr 2015. On an undetermined date, the patient experienced swelling, redness, pain/tender in 4 x 7 cm area for four days. Outcome of the event was unknown. Events were reported as non-serious and causality of the events was not reported.
Age: 19.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Erythema, Local swelling, Pain, Tenderness
Clinical narrative: Case number PHHY2015US123998, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 573752) website on 05 Oct 2015. This report refers to a 19 year old female patient. Medical history and concomitant medication were not provided. The patient was vaccinated with BEXSERO (batch number: 146101) intramuscularly, into the left arm on 10 Apr 2015. On an undetermined date, the patient experienced swelling, redness, pain/tender in 4 x 7 cm area for four days. Outcome of the event was unknown. Events were reported as non-serious and causality of the events was not reported.
Age: 11.0
Sex: F
Vaccine: MEN, TDAP, MEN, TDAP
Symptoms: Blood glucose, Eye movement disorder, Fall, Malaise, Muscle rigidity
Clinical narrative: Case number PHHY2015US098505 is an initial spontaneous report from a healthcare professional via Vaccine Adverse Event Reporting System (VAERS ID 575695) received on 11 Aug 2015. This report refers to 11-year-old female patient. Medical history and concomitant medications were not reported. She was vaccinated with meningococcal vaccine (manufacturer and batch number: unknown) in her arm and TDAP (manufacturer and batch number: unknown) in her arm on 27 Apr 2015. On the same date, she stated that she did not feel well and seconds later fainted/had seizure, including rigid body and eyes rolled back. She fell with her face down on the floor, turned white, discolored, and unresponsive. The blood sugar levels and blood pressure were taken by the clinic nurse (results not provided). The outcome of the events was reported as recovered. The events were reported as non-serious. Causality was not reported. Seriousness of "had seizure" was upgraded based on available information in the source document.
Age: 11.0
Sex: F
Vaccine: MEN, TDAP, MEN, TDAP
Symptoms: Pallor, Seizure, Skin discolouration, Syncope, Unresponsive to stimuli
Clinical narrative: Case number PHHY2015US098505 is an initial spontaneous report from a healthcare professional via Vaccine Adverse Event Reporting System (VAERS ID 575695) received on 11 Aug 2015. This report refers to 11-year-old female patient. Medical history and concomitant medications were not reported. She was vaccinated with meningococcal vaccine (manufacturer and batch number: unknown) in her arm and TDAP (manufacturer and batch number: unknown) in her arm on 27 Apr 2015. On the same date, she stated that she did not feel well and seconds later fainted/had seizure, including rigid body and eyes rolled back. She fell with her face down on the floor, turned white, discolored, and unresponsive. The blood sugar levels and blood pressure were taken by the clinic nurse (results not provided). The outcome of the events was reported as recovered. The events were reported as non-serious. Causality was not reported. Seriousness of "had seizure" was upgraded based on available information in the source document.
Age: 11.0
Sex: F
Vaccine: MEN, TDAP, MEN, TDAP
Symptoms: Blood glucose, Eye movement disorder, Face injury, Fall, Malaise
Clinical narrative: Case number PHHY2015US098505 is an initial spontaneous report from a healthcare professional via Vaccine Adverse Event Reporting System (VAERS ID 575695) received on 11 Aug 2015. This report refers to 11-year-old female patient. Medical history and concomitant medications were not reported. She was vaccinated with meningococcal vaccine (manufacturer and batch number: unknown) in her arm and TDAP (manufacturer and batch number: unknown) in her arm on 27 Apr 2015. On the same date, she stated that she did not feel well and seconds later fainted/had seizure, including rigid body and eyes rolled back. She fell with her face down on the floor, turned white, discolored, and unresponsive. The blood sugar levels and blood pressure were taken by the clinic nurse (results not provided). The outcome of the events was reported as recovered. The events were reported as non-serious. Causality was not reported. Seriousness of "had seizure" was upgraded based on available information in the source document.
Age: 11.0
Sex: F
Vaccine: MEN, TDAP, MEN, TDAP
Symptoms: Muscle rigidity, Pallor, Seizure, Skin discolouration, Syncope
Clinical narrative: Case number PHHY2015US098505 is an initial spontaneous report from a healthcare professional via Vaccine Adverse Event Reporting System (VAERS ID 575695) received on 11 Aug 2015. This report refers to 11-year-old female patient. Medical history and concomitant medications were not reported. She was vaccinated with meningococcal vaccine (manufacturer and batch number: unknown) in her arm and TDAP (manufacturer and batch number: unknown) in her arm on 27 Apr 2015. On the same date, she stated that she did not feel well and seconds later fainted/had seizure, including rigid body and eyes rolled back. She fell with her face down on the floor, turned white, discolored, and unresponsive. The blood sugar levels and blood pressure were taken by the clinic nurse (results not provided). The outcome of the events was reported as recovered. The events were reported as non-serious. Causality was not reported. Seriousness of "had seizure" was upgraded based on available information in the source document.
Age: 11.0
Sex: F
Vaccine: MEN, TDAP, MEN, TDAP
Symptoms: Unresponsive to stimuli
Clinical narrative: Case number PHHY2015US098505 is an initial spontaneous report from a healthcare professional via Vaccine Adverse Event Reporting System (VAERS ID 575695) received on 11 Aug 2015. This report refers to 11-year-old female patient. Medical history and concomitant medications were not reported. She was vaccinated with meningococcal vaccine (manufacturer and batch number: unknown) in her arm and TDAP (manufacturer and batch number: unknown) in her arm on 27 Apr 2015. On the same date, she stated that she did not feel well and seconds later fainted/had seizure, including rigid body and eyes rolled back. She fell with her face down on the floor, turned white, discolored, and unresponsive. The blood sugar levels and blood pressure were taken by the clinic nurse (results not provided). The outcome of the events was reported as recovered. The events were reported as non-serious. Causality was not reported. Seriousness of "had seizure" was upgraded based on available information in the source document.
Age: 11.0
Sex: M
Vaccine: HPV4, FLUN4, HPV4, MEN, TDAP
Symptoms: Syncope
Clinical narrative: Case number PHHY2015US100935, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 577006) website on 11 Aug 2015. This report refers to an 11 year old male patient. Medical history included Horner's syndrome. Concomitant medication was not reported. On 04 Sep 2014, the patient was vaccinated with meningococcal vaccine (manufacturer and batch number unknown); FLUMIST (other manufacturer, batch number unknown) and TDAP (other manufacturer, batch number unknown) and first dose of GARDASIL (batch number unknown) intramuscular into left arm. It was reported that on the same day the patient fainted 8 times after receiving the first dose of GARDASIL. The patient sought unspecified medical attention. No treatment was given and no laboratory tests were performed. Therapy with GARDASIL was continued. On 05 Jan 2015 and on 29 Apr 2015 the patient received second and third dose of GARDASIL (batch number unknown). It was also stated that the patient received his 2nd and 3rd doses of GARDASIL at 5 and 8 months after the 1st dose, which was other than indicated in the prescribing information. The outcome of the event was unknown. Causality assessment was not reported. Events were reported as non-serious. Seriousness assessment of the event fainting was upgraded based on information available in the source documents.
Age: 83.0
Sex: F
Vaccine: PPV, PPV, PPV
Symptoms: Erythema, Peripheral swelling
Clinical narrative: This spontaneous report as received from a registered nurse refers to an 82 year old female patient. The patient's medical history included open heart surgery. The patient had no drug reactions or allergies. On 24-SEP-2015, the patient was vaccinated with PNEUMOVAX 23 lot # K007826, expiration date 03-FEB-2016, dose 0.5 ml, subcutaneously, in right arm. On 25-SEP-2015, (also reported as second day after vaccination), the patient experienced swelling in her right arm where she received PNEUMOVAX 23. On 26-SEP-2015, (also reported as third day after vaccination), a red line started to appear at her finger tips and went all the way up to her right shoulder. The patient went to an emergency room for this event where an unspecified physician diagnosed this as a local allergic reaction. The patient was not admitted to the hospital. She was treated with prednisone (manufacturer unknown) and doxycycline. The outcome of local allergic reaction was reported as recovered on an unknown date in 2015. Causality assessment was not provided. The registered nurse requested a lot check. Follow up information was received from the nurse on 24-DEC-2015 concerning an 83 year old female patient. On 24-SEP-2015 at 9:00, the patient was vaccinated with the first dose of PNEUMOVAX 23. The patient was not ill at the time of vaccination. The onset of the event of local allergic reaction (reported as swelling and redness of arm) was on 25-SEP-2015 at 15:00. The reporter considered the event to be medically significant. Additional information has been requested. Patient information, suspect therapy details, event onset, serious criteria and narrative were updated.
Age: 83.0
Sex: F
Vaccine: PPV, PPV, PPV
Symptoms: Erythema, Hypersensitivity, Injection site erythema, Injection site hypersensitivity, Injection site swelling
Clinical narrative: This spontaneous report as received from a registered nurse refers to an 82 year old female patient. The patient's medical history included open heart surgery. The patient had no drug reactions or allergies. On 24-SEP-2015, the patient was vaccinated with PNEUMOVAX 23 lot # K007826, expiration date 03-FEB-2016, dose 0.5 ml, subcutaneously, in right arm. On 25-SEP-2015, (also reported as second day after vaccination), the patient experienced swelling in her right arm where she received PNEUMOVAX 23. On 26-SEP-2015, (also reported as third day after vaccination), a red line started to appear at her finger tips and went all the way up to her right shoulder. The patient went to an emergency room for this event where an unspecified physician diagnosed this as a local allergic reaction. The patient was not admitted to the hospital. She was treated with prednisone (manufacturer unknown) and doxycycline. The outcome of local allergic reaction was reported as recovered on an unknown date in 2015. Causality assessment was not provided. The registered nurse requested a lot check. Follow up information was received from the nurse on 24-DEC-2015 concerning an 83 year old female patient. On 24-SEP-2015 at 9:00, the patient was vaccinated with the first dose of PNEUMOVAX 23. The patient was not ill at the time of vaccination. The onset of the event of local allergic reaction (reported as swelling and redness of arm) was on 25-SEP-2015 at 15:00. The reporter considered the event to be medically significant. Additional information has been requested. Patient information, suspect therapy details, event onset, serious criteria and narrative were updated.
Age: 83.0
Sex: F
Vaccine: PPV, PPV, PPV
Symptoms: Erythema, Hypersensitivity, Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report as received from a registered nurse refers to an 82 year old female patient. The patient's medical history included open heart surgery. The patient had no drug reactions or allergies. On 24-SEP-2015, the patient was vaccinated with PNEUMOVAX 23 lot # K007826, expiration date 03-FEB-2016, dose 0.5 ml, subcutaneously, in right arm. On 25-SEP-2015, (also reported as second day after vaccination), the patient experienced swelling in her right arm where she received PNEUMOVAX 23. On 26-SEP-2015, (also reported as third day after vaccination), a red line started to appear at her finger tips and went all the way up to her right shoulder. The patient went to an emergency room for this event where an unspecified physician diagnosed this as a local allergic reaction. The patient was not admitted to the hospital. She was treated with prednisone (manufacturer unknown) and doxycycline. The outcome of local allergic reaction was reported as recovered on an unknown date in 2015. Causality assessment was not provided. The registered nurse requested a lot check. Follow up information was received from the nurse on 24-DEC-2015 concerning an 83 year old female patient. On 24-SEP-2015 at 9:00, the patient was vaccinated with the first dose of PNEUMOVAX 23. The patient was not ill at the time of vaccination. The onset of the event of local allergic reaction (reported as swelling and redness of arm) was on 25-SEP-2015 at 15:00. The reporter considered the event to be medically significant. Additional information has been requested. Patient information, suspect therapy details, event onset, serious criteria and narrative were updated.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Erythema, Eyelid oedema, Eyelids pruritus
Clinical narrative: Child reports back to clinic after leaving and presents with swelling/itching on right eyelid and erythema around right eye. Mother gave 25 mg of Benadryl po. Swelling and itching resolved by 1:00PM.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Joint crepitation, Pain, Pain in extremity, Paraesthesia, Peripheral swelling
Clinical narrative: -Pain, swelling when moving arm. -Tingling in arm and fingers. -Popping sensation.
Age: 49.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Musculoskeletal disorder, Pain in extremity
Clinical narrative: Patient developed (L) arm pain and limited arm use after vaccine. She let us know today (12/29/15). No weakness or numbness, referred for Physical Therapy.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Rash generalised, Urticaria
Clinical narrative: Case number PHEH2015US015166, is an initial spontaneous report from a physician received on 23 Jul 2015 with follow up report received from physician on 21 Sep 2015. This report refers to an 18-year-old female patient. Medical history and concomitant medications were not reported. She was vaccinated with BEXSERO (batch number: 146101) at a dose of 0.5 ml intramuscularly into left deltoid on 08 Jun 2015 at 15:30 PM. On an unknown date she had body rash. On 13 Jun 2015, she experienced hives on whole body. Treatment medication included BENADRYL oral. The outcome of hives was reported as complete recovery on 07 Jul 2015. The outcome of body rash was not reported. The seriousness of the events was not reported. Causality was reported as probable. Seriousness of the event hives whole body was upgraded based on available information in the source document. Follow up report received from physician on 21 Sep 2015: Medical history and event hives whole body added. Vaccine batch number, dose and time, age, patient demography updated.
Sex: M
Vaccine: FLU3, MENB
Symptoms: Diarrhoea, Somnolence
Clinical narrative: Case number PHEH20015US021291 is an initial spontaneous report from a health care professional received on 15 Oct 2015. This report refers to a male patient of an unknown age. The patient was vaccinated with BEXSERO (batch number: 148901, expiry date: 30 Sep 2016) along with FLUZONE (other manufacturer, batch number: not reported) on  an unknown date. After vaccinations, he experienced falling sleeping and diarrhea. The outcome of the events was unknown. The seriousness and causality of the events were not reported.
Age: 57.0
Sex: F
Vaccine: FLUX
Symptoms: Hypersensitivity, Peripheral swelling, Rash
Clinical narrative: Rash; swelling of left arm; localized allergic reaction.
Sex: U
Vaccine: MENB
Symptoms: Influenza like illness, Pyrexia
Clinical narrative: Case number PHEH2015US015245 is an initial spontaneous report from a physician via a pharmaceutical company (reference nr. A201401552) received on 03 Aug 2015. This report refers to a patient of an unknown age and gender. Medical history and concomitant medications were not reported. The patient was vaccinated with BEXSERO (batch number: not reported) on an unknown date. Post vaccination the patient presented with fever and flu like symptoms. The outcome, seriousness and causality of the events were not reported.
Age: 51.0
Sex: F
Vaccine: MENB
Symptoms: Accidental exposure to product, Exposure via direct contact, Eye irrigation, No adverse event
Clinical narrative: Case number PHEH2015US016326, is an initial spontaneous report from a health care professional received on 18 Aug 2015, with a follow up report from a health care professional received on 06 Oct 2015. This report refers to a 51 year old female patient. Her vaccination history included administration of first dose of BEXSERO, (batch number and expiry date: not reported) on an unknown date. No concomitant medication was reported. The patient was vaccinated with second dose of BEXSERO, (batch number: 146101, expiry date: not reported) into the deltoid on 01 Jun 2015 at 02:33 PM. The administering nurse splashed a "liquid of unknown origin" to face hitting right eye, lip and mouth when attempting to place the BEXSERO vaccine syringe in the sharps container. Patient rinsed her eye in the sink and did not seek medical attention. She did not report further incidents or follow ups on this incident. No adverse event was reported following accidental exposure to product. Follow up report from a health care professional received on 06 Oct 2015: Updated patient initials, added vaccination history, batch number, vaccination date and time, region of administration, event verbatim and reporter's comment updated.
Age: 24.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Raised, swollen bump under skin at injection site, painful and tender to touch and movement. Approx quarter size. Still present as of 12/29/2015.
Sex: U
Vaccine: MENB
Symptoms: Headache, Pain, Vomiting
Clinical narrative: Case number PHEH2015US015227 is an initial spontaneous report from a nurse received on 03 Aug 2015. This report refers of unspecified age and gender. Medical history and concomitant medications were not reported. The patient was vaccinated with BEXSERO, (batch number: unknown) on an unknown date. On an unknown date after the vaccination the patient had vomiting, pain and headache. The outcome, seriousness and causality assessment of the events was unknown.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Pain, Swelling
Clinical narrative: Case number PHEH2015US016640, is an initial spontaneous report from a health care professional received on 24 Aug 2015.This report refers to an 18 years old female patient. Medical history and concomitant medications were not reported. She was vaccinated with BEXSERO, (batch number: 146101, expiry date: 30 Apr 2016) into left arm intramuscularly on 03 Aug 2015. On the same day following the vaccination the patient experienced pain and swelling. The outcome, seriousness and causality of the event were not reported.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Injection site nodule, Pain in extremity
Clinical narrative: Case number PHEH2015US020627, is an initial spontaneous report from a consumer received on 12 Oct 2015. This report refers to a 19-year-old female patient. Past medical history was not reported. Past medical vaccination included flu vaccine of unknown manufacture on 29 Sep 2015 (10 days prior to BEXSERO). Concomitant medication included loratadine (manufacturer unknown). She was vaccinated with BEXSERO (batch number and expiry date: not reported) at left arm on 09 Oct 2015. On same day, few hours after vaccination she started experiencing a sore arm, and there was a knot at the injection site. She stated that her arm was more sore than she usually experiences with vaccines, and had lasted longer than usual. The symptoms were improving, but not yet resolved. The seriousness and causality of events were not reported.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Pallor
Clinical narrative: Pt turned pale.
Age: 5.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Patient received her nasal Flumist on 12/7/15 at our flu clinic. She returned for her 5 year check-up on 12/16/15 and was given her MMR and Varicella.
Age: 40.0
Sex: M
Vaccine: FLU3
Symptoms: Bursitis, Insomnia, Mobility decreased, Musculoskeletal pain
Clinical narrative: Severe shoulder pain following the treatment loss of mobility of right shoulder and extreme pain, loss of sleep, family Dr states bursitis and rehab needed.
Age: 61.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Erythema, Injection site erythema, Local swelling, Pruritus, Tenderness
Clinical narrative: Patient came in day 2 post-vaccine - observed (L) back of arm with red 25 cm x 7 cm area - non raised and no itching - non tender. Reported that on day 1 post-vaccine - red, raised area tender to touch with mild itching.
Age: 65.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Drug administered at inappropriate site, Injection site joint effusion
Clinical narrative: Patient says vaccine FLUZONE given too high in her shoulder and resulted in fluid accumulation. Has tried anti-inflammatories and antibiotics but no change. Trying steroids next to decrease fluid.
Age: 82.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Dizziness, Malaise
Clinical narrative: On or about 09/01/2015 went to pharmacy and received the senior flu immunization. On the second day after, at exactly at the same time we both began to feel slightly ill at ease which quickly became worse over the next several days to dizziness, weakness and other hand to describe symptoms that really have not fully left completely to this day, some 3 months later. This 4x vaccine should not be given to seniors of advanced age without prior warning.
Age: 5.0
Sex: F
Vaccine: FLUN4
Symptoms: Dry eye, VIIth nerve paralysis
Clinical narrative: R sided Bells Palsy.
Age: 35.0
Sex: M
Vaccine: FLU3
Symptoms: Deafness unilateral, Paraesthesia, Respiratory distress, Trismus
Clinical narrative: Tingling in hands and feet as well as face. Hearing loss in right ear and a locked jaw for 48 hours after receiving vaccine. Also, patient reports distressed breathing.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Muscle spasms, Muscular weakness
Clinical narrative: Muscle weakness legs and shoulders, back spasms.
Age: 67.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Activities of daily living impaired, Chills, Fatigue, Impaired driving ability, Injection site pain
Clinical narrative: Pain in left arm where vaccine was administered 10/28/2015, pain, chills, fatigue, after approximately 4 to 5 hours after injection.  The pain became extreme and worsened during the night, I was unable to have use of my left arm, unable to roll over in bed,difficulty getting out of bed, shower, clothe myself, cook food, carry groceries into my house, drive my vehicle, lacked the ability to live alone. PCP 11/10/2015, Tramadol 50mg 11/17/2015, Rheumatologist 11/21/2015, PCP 12/08/2015, Rheumatologist 12/12/2015.
Age: 67.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Mobility decreased, Musculoskeletal disorder, Pain
Clinical narrative: Pain in left arm where vaccine was administered 10/28/2015, pain, chills, fatigue, after approximately 4 to 5 hours after injection.  The pain became extreme and worsened during the night, I was unable to have use of my left arm, unable to roll over in bed,difficulty getting out of bed, shower, clothe myself, cook food, carry groceries into my house, drive my vehicle, lacked the ability to live alone. PCP 11/10/2015, Tramadol 50mg 11/17/2015, Rheumatologist 11/21/2015, PCP 12/08/2015, Rheumatologist 12/12/2015.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site urticaria
Clinical narrative: Local hives, swelling, and redness to injection site of right anterolateral thigh.
Age: 12.0
Sex: M
Vaccine: FLUN4, HPV9, MNQ, TDAP
Symptoms: Injection site pain, Mobility decreased
Clinical narrative: Pain at injection site, right deltoid, which lasted for 3 days, pain resolved for approximately 1 week and returned 3 to 4 days ago.  Patient reports pain is so severe mobility is limited.
Age: 1.05
Sex: M
Vaccine: IPV, MMR, VARCEL
Symptoms: Erythema of eyelid, Eyelid rash, Rash erythematous
Clinical narrative: After getting vaccine my child fell asleep and I drove around to let him sleep for about 1 hour when I got home I noticed my child had a red raised rash on the lateral side of his left face mostly around the eye. It then seemed to get worse we then called his doctors office and poison control after another hour the rash resolved.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Induration, bruising and tenderness, swelling at injection site.  Size of an egg. Lasted until 12/30/15.  Benadryl cream helped with symptoms.
Age: 0.21
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Death, Disease complication, Echocardiogram, Gene mutation, Ultrasound scan
Clinical narrative: This patient Died at Hospital on 12/09/2015 of complications related to ACTA2.
Age: 0.21
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: X-ray
Clinical narrative: This patient Died at Hospital on 12/09/2015 of complications related to ACTA2.
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Pain in extremity
Clinical narrative: Patient had soreness in injection arm from the night after vaccine until now. Patient still has soreness now after 2 months.
Age: 1.0
Sex: M
Vaccine: FLUX, HEPA, MMR, VARCEL
Symptoms: Pyrexia, Skin lesion
Clinical narrative: Patient developed approximately 100 lesions across his body, including legs, hands, mouth, and genitals. Most were small, but a few were 1/2 inch in diameter. He also had a low-grade Fever that lasted for 4 days.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Red, swollen, painful at injection site and increasing in size. Prescribed antibiotics at Urgent Care AM 12/25/2015.
Age: 14.0
Sex: F
Vaccine: FLU4, HPV9
Symptoms: Fatigue, Injection site pain, Malaise, Nausea, Pyrexia
Clinical narrative: Episodes of malaise and nausea and fatigue, initially occurred at dance class after getting vaccine, occurred on a daily basis, mainly in afternoon, soreness at injection site which lasted approx. 1 week. Felt feverish with hive-like reaction 5 nights after vaccine. Evaluated in our office 12/15- nonfocal exam except for some tenderness at injection site, right deltoid muscle. Sx's appeared to resolve several days after office visit on 12/15.
Age: 14.0
Sex: F
Vaccine: FLU4, HPV9
Symptoms: Urticaria
Clinical narrative: Episodes of malaise and nausea and fatigue, initially occurred at dance class after getting vaccine, occurred on a daily basis, mainly in afternoon, soreness at injection site which lasted approx. 1 week. Felt feverish with hive-like reaction 5 nights after vaccine. Evaluated in our office 12/15- nonfocal exam except for some tenderness at injection site, right deltoid muscle. Sx's appeared to resolve several days after office visit on 12/15.
Age: 63.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: Sore arm, sore muscle in left arm at injection site.
Age: 75.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: Patient experienced soreness, swelling, redness, and itching along with a rash surrounding the injection site. The rash is still visible 6 days after administration.
Age: 42.0
Sex: M
Vaccine: FLU3, IPV, MMR
Symptoms: Headache, Injection site pain, Injection site swelling, Myalgia, Tenderness
Clinical narrative: Swollen, tender injection site. Headache. Muscle aches. Tender armpit.
Age: 77.0
Sex: M
Vaccine: FLUX
Symptoms: Gingivitis, Immunodeficiency, Nasopharyngitis, Paronychia
Clinical narrative: COLD SYMPTOMS, INFECTED GUMS, PARONYCHIA, DEVELOPED SEVERE COLD SYMPTOMS 12/30/2015.  IMMUNE SYSTEM COMPROMISED.
Age: 65.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site rash
Clinical narrative: RASH ON THE ARM WHERE INJECTION WAS ADMINISTERED.
Age: 91.0
Sex: F
Vaccine: FLU3
Symptoms: Discomfort, Fatigue, Guillain-Barre syndrome, Hypoaesthesia, Limb discomfort
Clinical narrative: Pt. felt tired days following administration. Pt discomfort increased to heaviness, numbness and pain in extremities. "Guillain-Barre syndrome". Treatment - NSAIDS, steroids, pain meds.
Age: 91.0
Sex: F
Vaccine: FLU3
Symptoms: Nuclear magnetic resonance imaging, Pain in extremity
Clinical narrative: Pt. felt tired days following administration. Pt discomfort increased to heaviness, numbness and pain in extremities. "Guillain-Barre syndrome". Treatment - NSAIDS, steroids, pain meds.
Age: 1.01
Sex: M
Vaccine: FLU3, HEPA, HIBV, MMRV
Symptoms: Febrile convulsion, Influenza virus test negative, Pyrexia, Respiratory syncytial virus test negative
Clinical narrative: Vaccines 12/22. Fever 104 degrees 12/23. Febrile seizure - ER, no tx.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Local redness around injection site, soreness at injection site and shoulder.
Age: 66.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Contusion, Night sweats, Rash, Weight decreased
Clinical narrative: PREVNAR in right arm, had large "bubble", went away after 36 hours, bruise developed, developed rash on thigh above knee unilaterally, went away. Has developed night sweats then night sweats dissipated, lost wt (13 lbs).
Age: 79.0
Sex: U
Vaccine: FLU3, PNC13, VARZOS
Symptoms: Swelling
Clinical narrative: Reaction to ZOSTAVAX arm. Swelling, given erythromycin from ER and prednisone.
Age: 68.0
Sex: M
Vaccine: FLU3, PNC13, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Red, swollen and painful upper (L) arm will be evaluated by primary care physician.
Age: 91.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Dizziness, Malaise
Clinical narrative: On or about 09/01/2015 my spouse, 82 and I, 91 went to pharmacy and received the senior flu immunization. On the second day after, at exactly at the same time we both began to feel slightly ill at east which quickly became worse over the next several days to dizziness, weakness and other hard to describe symptoms that really have not fully left completely to this day, some 3 months later. This 4x vaccine should not be given to seniors of advanced age without prior warning.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased
Clinical narrative: Patient returned to pharmacy on 12-22-15 stating she had to visit her doctor because she cannot raise her arm since she received the Influenza vaccine.
Age: 18.0
Sex: M
Vaccine: HEPA, HPV9
Symptoms: Comminuted fracture, Computerised tomogram head normal, Facial bones fracture, Fall, Syncope
Clinical narrative: Syncopal episode after receiving immunization (within a few minutes); fell from exam table where he was sitting injured two upper central incisors; sustained a comminuted nasal fracture.
Age: 18.0
Sex: M
Vaccine: HEPA, HPV9
Symptoms: Tooth injury, X-ray abnormal
Clinical narrative: Syncopal episode after receiving immunization (within a few minutes); fell from exam table where he was sitting injured two upper central incisors; sustained a comminuted nasal fracture.
Age: 7.0
Sex: F
Vaccine: VARCEL
Symptoms: Body temperature increased, Erythema, Pain, Pruritus, Rash
Clinical narrative: Swelling, pain, itching, rash - thigh, face, low grade temp 99.4, redness.
Age: 7.0
Sex: F
Vaccine: VARCEL
Symptoms: Swelling
Clinical narrative: Swelling, pain, itching, rash - thigh, face, low grade temp 99.4, redness.
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Decreased appetite, Headache, Injection site erythema, Injection site induration
Clinical narrative: I received the PNEUMOVAX 23 vaccine and experienced the following untoward events - severe headache, fever, chills, nausea, malaise, loss of appetite, injection site reactions (pain, induration, pruritis, erythema). It also caused an exacerbation of herpes on my lips and intra-nasally.
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site pruritus, Malaise, Nasal herpes, Nausea
Clinical narrative: I received the PNEUMOVAX 23 vaccine and experienced the following untoward events - severe headache, fever, chills, nausea, malaise, loss of appetite, injection site reactions (pain, induration, pruritis, erythema). It also caused an exacerbation of herpes on my lips and intra-nasally.
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Oral herpes, Pyrexia
Clinical narrative: I received the PNEUMOVAX 23 vaccine and experienced the following untoward events - severe headache, fever, chills, nausea, malaise, loss of appetite, injection site reactions (pain, induration, pruritis, erythema). It also caused an exacerbation of herpes on my lips and intra-nasally.
Age: 57.0
Sex: F
Vaccine: TYP
Symptoms: Laboratory test normal, Urticaria
Clinical narrative: Severe urticaria sl after typhoid vaccine.
Age: 56.0
Sex: F
Vaccine: MMR
Symptoms: Eyelid oedema, Nausea, Ocular hyperaemia, Oropharyngeal pain, Pyrexia
Clinical narrative: On 12/24 Noticed a rash from head to toe. 12/25 nauseous, fever 101 degrees oral. Vomit x 1, rash present swelling around eyes, red eyes, sore throat. 12/26 nauseous, rash. 12/27 nauseous, rash - started BENADRYL 25 mg 1 tab BID. 12/28 BENADRYL 25 mg 1 tab BID - rash slowly resolving 12/29. Rash lessening. Reported to employee health.
Age: 56.0
Sex: F
Vaccine: MMR
Symptoms: Rash generalised, Vomiting
Clinical narrative: On 12/24 Noticed a rash from head to toe. 12/25 nauseous, fever 101 degrees oral. Vomit x 1, rash present swelling around eyes, red eyes, sore throat. 12/26 nauseous, rash. 12/27 nauseous, rash - started BENADRYL 25 mg 1 tab BID. 12/28 BENADRYL 25 mg 1 tab BID - rash slowly resolving 12/29. Rash lessening. Reported to employee health.
Age: 1.02
Sex: F
Vaccine: HEPA, MMR, PNC13
Symptoms: Rash generalised
Clinical narrative: Patient developed a raised rash throughout body on day 10 after receiving vaccine.
Age: 56.0
Sex: M
Vaccine: PNC13
Symptoms: Headache, Injection site erythema, Myalgia, Peripheral swelling, Vomiting
Clinical narrative: On the afternoon following vaccination, pt developed arm swelling, redness at injection site, accompanied by myalgias, vomiting, headache which persisted for 3 days.
Age: 0.34
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV1
Symptoms: Clostridium test negative, Culture stool negative, Diarrhoea, Giardia test negative, Haematochezia
Clinical narrative: 12/5/15 - onset of frequency watery stools - 10-12x/day. Stools tested several times for blood and were negative until 12/23/15 (+) hemoccult - visible blood and mucous in stool. Switched to alimentum, hypoallergenic formula 12/24 with decrease in diarrhea. No ill cultures. Possible protein intolerance after rotavirus vaccine.
Age: 0.34
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV1
Symptoms: Mucous stools, Occult blood positive
Clinical narrative: 12/5/15 - onset of frequency watery stools - 10-12x/day. Stools tested several times for blood and were negative until 12/23/15 (+) hemoccult - visible blood and mucous in stool. Switched to alimentum, hypoallergenic formula 12/24 with decrease in diarrhea. No ill cultures. Possible protein intolerance after rotavirus vaccine.
Age: 1.18
Sex: M
Vaccine: FLU3, HEPA, MMRV, VARCEL
Symptoms: Rash
Clinical narrative: On 12-14-15 patient was given both MMRV and Varicella. Patient was treated 10 days prior to this for positive strep. Parent reported rash on 12-24-15, was seen by provider and recommended BENADRYL PRN. As of 12-29-15 rash was gone, no other symptoms reported.
Age: 61.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Onsite reaction (redness, swelling) where ZOSTAVAX was administered. (left arm)
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Rash, Rash pruritic
Clinical narrative: Large reaction at site of injection (red and raised) and small bumps around neck (front and back) and chest area. Patient states they itch.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site induration, Injection site pruritus, Injection site reaction, Rash macular
Clinical narrative: Pt had itchy hard blotchy area 3 inch around injection site about 6 days after administering vaccine but was gone the next day after taking BENADRYL.
Age: 54.0
Sex: U
Vaccine: VARZOS
Symptoms: Arthralgia, Pruritus, Swelling
Clinical narrative: Swelling next day, then increased to elbow pain 1 week started to resolved. Some itching, took BENADRYL.
Age: 0.13
Sex: M
Vaccine: DTAPHEPBIP, HIBV, MMRV, RV5
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Pt given PROQUAD (MMR and varicella) at wrong age. Given at age 6 weeks.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Drug hypersensitivity, Oral mucosal blistering
Clinical narrative: Information has been received from a pharmacist referring to a 60 year old male patient, who was allergic to penicillin. The patient had no medical history. On 07-DEC-2015 the patient was vaccinated with a dose of ZOSTAVAX (dose and route were unknown, lot# L029484 with expired date 06-NOV-2016). Concomitant therapies included AFLURIA, JUBLIA, diazepam (manufacturer unknown) and PERCOCET. On an unknown date in December 2015 the patient developed blisters on the roof of his mouth. The patient called the pharmacy for medical attention. No treatment was given to him and no lab tests were performed. The outcome of the event was reported as not recovered. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: FLUX, PNC13
Symptoms: Pruritus, Rash, Rash erythematous, Rash macular, Skin warm
Clinical narrative: 68 y/o F with PMH uterine leiomyoma, radial styloid tenosynovitis, pain in limb, sprained ligament, diabetes, essential HTN, thyroid disease still which long-standing, vague, intermittent  RDQ discomfort. Received flu shot and PREVNAR in left deltoid on 9/14/15. Patient experienced itching in upper arm that night, next day a rash developed which has grown over the past week but stable in past 3 days. Itchy, mild to moderate. Not painful, Not having fevers, at work, feels fine otherwise. No other trauma or irritation to the area noted by the patient. The rash is below the site of injection. Per outpatient follow-up note 9/21 no distress, temp 98.2, HR 72, (L) arm erythematous, macular rash of 8 cm with mild warmth, not tender or indurated full ROM in arm in all directions. Infection unlikely in s/o (-) fever. Patient advised to take CLARITIN, ZYRTEC, or BENADRYL for the itch and to contact if any fever, if rash spreads further or if patient feels unwell. No rash noted per outpatient physical exam on 10/8.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Syncope, Tremor
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to a 11 year old female patient. The patient did not has any medical history, concurrent conditions or drug reactions/allergies. On 19-OCT-2015, the patient was vaccinated with the first dose of GARDASIL 9 (route, lot # and expiration date were not reported), and on 23-DEC-2015, the patient received the second dose of GARDASIL 9 intramuscularly, lot # L011846 (expiration date not reported), also. No concomitant medications were reported. On 23-DEC-2015, shortly after the administration of the second dose, the patient experienced shaking and then fainted. The reporting nurse stated that the patient received 2 liters of oxygen via nasal cannula, her vital signs were taken (which were within normal range), an icepack was provided to the patient and was finally monitored in an office for some time prior to being sent home upon recovery. At the time of the report, the outcome of shaking and syncope was reported as recovered. The relatedness between the events and GARDASIL 9 was not provided. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Regurgitation
Clinical narrative: This spontaneous report was received from a medical assistant regarding a patient of unknown age and unknown gender. The patient's concurrent conditions and drug allergies were none. On 22-DEC-2015, the patient was vaccinated with ROTATEQ via oral route (strength, dose number and dosing regimen unknown). Concomitant medications were none. On the same day, 22-DEC-2015, shortly after vaccinated with ROTATEQ the patient regurgitated. No diagnostic tests were performed. The patient did not sought medical attention and no treatment was provided for the events. The outcome of the event was unknown. The relatedness of the event with ROTATEQ was not reported. No product quality complaint (PQC) was reported. Additional information has been requested.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site pruritus
Clinical narrative: This spontaneous report was received from a 75 year old male patient with asthma and high blood pressure and refers to himself. The patient was allergic to unspecified sulfonamides (reported as Sulfa) and unspecified penicillin. On 23-DEC-2015 (reported as "vaccine was given last Wednesday"), the patient was vaccinated with a dose of ZOSTAVAX in the left arm, lot # reported as "RX 0911521-03764", (strength, dose, route of administration and expiration date were not provided). It was unspecified if the patient took any concomitant medications. On approximately 24-DEC-2015 (reported as "a day or two after injection was given"), the patient started feeling itching at the site of injection and when he felt/touched at the site of injection he felt pain. The patient did not receive the treatment for the adverse events. The patient did not have lab diagnostic studies performed. At the time of the report, the patient did not recover from the adverse events (the events did not improve). The patient did not seek medical attention. The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: MMR
Symptoms: Measles antibody negative
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 22-year-old female non-pregnant patient. The patient's concurrent conditions, medical history and concomitant therapy were not reported. On unknown dates, the patient was vaccinated with the first and the second dose of MMR II (dose, lot#, expiration date and route of administration were not reported). On an unspecified date, the patient had serologic testing that showed her response to measles was Immunoglobulin G (IgG) negative. The outcome of the event was unknown. Causality assessment was not provided. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 25-NOV-2015, the patient was vaccinated with an expired dose of ZOSTAVAX vial (expiration date February 2015, lot#, dose and route of administration were not provided). It was not specified by the reporter if the patient seek any medical attention. No adverse effects were reported. Additional information is not expected as the reporter did not wish to be contacted.