chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 7.0
Sex: F
Vaccine: FLU4
Symptoms: Streptococcus test negative
Clinical narrative: The day after receiving vaccine patient began c/o a sore throat, H/A, ear pain, abdominal pain, and a fever ranging from 101-102F.
Age: 64.0
Sex: M
Vaccine: FLU3
Symptoms: Mobility decreased, Musculoskeletal pain, Pain in extremity
Clinical narrative: Severe arm and shoulder pain, cannot lift arm past shoulder.
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Musculoskeletal pain, Neck pain, Pain, Pain in extremity, Sensory loss
Clinical narrative: 10/10 pain in left arm, left side of neck, left shoulder blade, decreased sensation in left arm and hand and unable to move extremity without pain.
Age: 15.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: injection site (varicella vaccine) posterior upper arm became very swollen and tender. Resolved without treatment after 2 days.
Age: 59.0
Sex: M
Vaccine: FLU4
Symptoms: Hypersensitivity, Sinusitis, Swelling face, Throat irritation
Clinical narrative: Employee has received flu shot yearly with not adverse effects. This year developed swelling over eyes and forehead and itching in her throat that lasted several hours. Also stated she felt like she does when she has a sinus infection. Reaction started within a few minutes of receiving vaccine and she was sent to emergency department for follow up. No hives, no difficulty breathing or swallowing. She was given Benadryl and Solu-Medrol IV.
Age: 46.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Erythema, Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Symptoms include: L arm was swollen, hot to the touch. This area extended to armpit, side of breast. Large red "hives." Pt had severe pain when she raised arm, states she could not use her arm due to the pain for 2 days. Some redness remains and area is tender, however pt has full use of her arm, warmth to touch is gone. Denies: Any previous reaction to a vaccine or vaccine component. Trouble breathing, stomach issues, fever, any other symptoms. Treatment Tried: Ibuprofen/TYLENOL, icing.
Age: 46.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site warmth, Pain, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Symptoms include: L arm was swollen, hot to the touch. This area extended to armpit, side of breast. Large red "hives." Pt had severe pain when she raised arm, states she could not use her arm due to the pain for 2 days. Some redness remains and area is tender, however pt has full use of her arm, warmth to touch is gone. Denies: Any previous reaction to a vaccine or vaccine component. Trouble breathing, stomach issues, fever, any other symptoms. Treatment Tried: Ibuprofen/TYLENOL, icing.
Age: 46.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Urticaria
Clinical narrative: Symptoms include: L arm was swollen, hot to the touch. This area extended to armpit, side of breast. Large red "hives." Pt had severe pain when she raised arm, states she could not use her arm due to the pain for 2 days. Some redness remains and area is tender, however pt has full use of her arm, warmth to touch is gone. Denies: Any previous reaction to a vaccine or vaccine component. Trouble breathing, stomach issues, fever, any other symptoms. Treatment Tried: Ibuprofen/TYLENOL, icing.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Abdominal pain, Activities of daily living impaired, Asthenia, Blood test, Computerised tomogram abdomen
Clinical narrative: Her symptoms started with breathing problems and extreme ear pain. Followed by chronic severe abdominal pain and chronic severe headaches. She is constantly nauseated, weak, fatigued.  She has not enough energy some days to go up the stairs in our house. Before, she was a competitive soccer player for 6 years, she could run for miles before. Now 1-2 minutes is too much and too painful for her. She gets so dizzy sometimes she cannot stand without holding onto a chair or a family member. We've taken her to pediatric specialists, had multiple blood tests, Cat Scans of her stomach, ultrasounds, she has been prescribed multiple over the counter medicines (all which do not work or make her feel worse).
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Dizziness, Dyspnoea, Dysstasia, Ear pain, Fatigue
Clinical narrative: Her symptoms started with breathing problems and extreme ear pain. Followed by chronic severe abdominal pain and chronic severe headaches. She is constantly nauseated, weak, fatigued.  She has not enough energy some days to go up the stairs in our house. Before, she was a competitive soccer player for 6 years, she could run for miles before. Now 1-2 minutes is too much and too painful for her. She gets so dizzy sometimes she cannot stand without holding onto a chair or a family member. We've taken her to pediatric specialists, had multiple blood tests, Cat Scans of her stomach, ultrasounds, she has been prescribed multiple over the counter medicines (all which do not work or make her feel worse).
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Headache, Nausea, Pain, Stool analysis, Ultrasound scan
Clinical narrative: Her symptoms started with breathing problems and extreme ear pain. Followed by chronic severe abdominal pain and chronic severe headaches. She is constantly nauseated, weak, fatigued.  She has not enough energy some days to go up the stairs in our house. Before, she was a competitive soccer player for 6 years, she could run for miles before. Now 1-2 minutes is too much and too painful for her. She gets so dizzy sometimes she cannot stand without holding onto a chair or a family member. We've taken her to pediatric specialists, had multiple blood tests, Cat Scans of her stomach, ultrasounds, she has been prescribed multiple over the counter medicines (all which do not work or make her feel worse).
Sex: U
Vaccine: MENB
Symptoms: Hypersensitivity
Clinical narrative: This is a spontaneous report from a contactable consumer. A patient of unspecified age ethnicity and gender received meningococcal group B (unknown if Trumenba or Bexsero), via an unspecified route of administration, on an unspecified date, at single dose, for immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced allergic reaction on an unspecified date with outcome of unknown. Follow-up (27Sep2016): New information received from a contactable consumer includes: reporter's address updated. Pfizer is Marketing Authorization Holder of meningococcal group b rlp2086 in the reporter's country. This may be a duplicate report if another Marketing Authorization Holder of meningococcal group b rlp2086 has submitted the same report to the regulatory authorities.
Sex: F
Vaccine: PPV
Symptoms: Headache, Nausea, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable pharmacist received via a Pfizer sales representative. A female patient of an unspecified age and ethnicity received PREVNAR 13, via an unspecified route of administration on an unspecified date at a single dose for immunization or PNEUMOVAX 23, via an unspecified route of administration on an unspecified date at an unspecified dose for immunization. The patient's medical history and concomitant medications were not reported. On an unknown date, the patient experienced nausea, headache, and fever for two to three days after receiving the vaccine. The outcome for the events of nausea, headache, and fever was unknown.
Sex: F
Vaccine: PNC13
Symptoms: Condition aggravated, Headache
Clinical narrative: This is a spontaneous report from a non-contactable consumer. A female patient of an unspecified age and ethnicity received PREVNAR 13, via an unspecified route of administration on an unspecified date at 0.5 ml single dose for immunization. Medical history included frequent headaches on an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously received PNEUMOVAX in 2014 for immunization and experienced headache at night after vaccination, however was not sure if that was related to the vaccination because she gets frequent headaches. The patient also received TDAP on an unknown date for immunization and she thought that she was going to die. On an unknown date, the patient experienced headache. The outcome was unknown. No follow-up attempts are possible. No further information is expected.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Diarrhoea, Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus
Clinical narrative: Left arm injection site red, indurated, pruritis, sore, and diarrhea.
Age: 54.0
Sex: F
Vaccine: FLUC4, PPV, TD
Symptoms: Headache, Injection site erythema, Injection site pain, Pyrexia
Clinical narrative: Patient states she has experienced fever, headache, injection site pain and redness starting the night of vaccination. The patient has taken Claritin and Motrin.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Large site reaction. ~3-4 inch diameter red, swollen area. Hot to the touch, painful, itchy.
Age: 11.0
Sex: F
Vaccine: MMRV, MNQ, TDAP
Symptoms: Rash, Rash erythematous, Rash pruritic
Clinical narrative: Fine red rash covering both arms, legs and back. Rash began on 10/2/2016. Rash is itchy.
Age: 66.0
Sex: M
Vaccine: PNC13
Symptoms: Erythema, Skin warm
Clinical narrative: RED WARM AREA ON SITE OF UPPER ARM.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Hypersensitivity, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: PATIENT SAID THE AREA FELT HOT, RED AND RAISED. SHE NOTICED IT ON MONDAY BUT DID NOT CONTACT US UNTIL FRIDAY. I RECOMMENDED SHE SEE MD, HOWEVER HER MD WAS OUT. RECOMMENDED GOING TO URGENT CARE. SHE DIDN'T WANT TO. SHE BOUGHT BENADRYL. SHE DID DECIDE TO GO TO URGENT CARE THE NEXT MORNING AFTER SHE SPOKE TO THE RPH ON DUTY. URGENT CARE FELT IT WAS AN ALLERGIC RXN TO SOMETHING IN THE IMZ BUT NOT THE ACTUAL ANTIGEN. SHE CONTINUED TO TAKE BENADRYL AND SHE IS MUCH BETTER TODAY.
Age: 8.0
Sex: F
Vaccine: FLU4
Symptoms: Cellulitis, Erythema, Induration, Skin warm
Clinical narrative: Left arm with +erythema, warm 10x9cm,+ induration, no fluctuance. Diagnosis of cellulitis and prescribed Clindamycin 75/5 20ml TID for 10 days.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Contusion, Peripheral swelling
Clinical narrative: Bruised area on arm and it was raised.
Age: 51.0
Sex: F
Vaccine: FLUX, TDAP
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Injection site pain, Pain, Sleep disorder
Clinical narrative: INTENSE BURNING UPON INJECTION THAT RAN DOWN MY ARM.  SINCE THEN INTENSE PAIN IN UPPER ARM AND SHOULDER.  UNABLE TO SLEEP DUE TO PAIN. UNABLE TO MOVE RIGHT ARM AND SHOULDER. THROBBING PAIN CONSTANT.
Age: 51.0
Sex: F
Vaccine: FLUX, TDAP
Symptoms: X-ray normal
Clinical narrative: INTENSE BURNING UPON INJECTION THAT RAN DOWN MY ARM.  SINCE THEN INTENSE PAIN IN UPPER ARM AND SHOULDER.  UNABLE TO SLEEP DUE TO PAIN. UNABLE TO MOVE RIGHT ARM AND SHOULDER. THROBBING PAIN CONSTANT.
Age: 54.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Injection site pain, Injection site pruritus, Injection site warmth, Pyrexia
Clinical narrative: Very sore, hot, itchy injection site reaction. Developed fever first night that lasted for 4 days. Injection site still very sore, warm, and itchy.
Age: 49.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Axillary pain, Breast pain, Erythema, Pain in extremity, Pyrexia
Clinical narrative: Extremely sore, red, arm and fever that started afternoon of vaccination. Pain also felt in armpit and left breast. Patient still feels very sore in left arm 5 days after immunization.
Age: 78.0
Sex: M
Vaccine: TDAP
Symptoms: Erythema, Pain in extremity, Tenderness, Thrombosis, Ultrasound scan abnormal
Clinical narrative: Patient reported sore arm below elbow to pharmacy on 09/23/16.  Advised to try cold packs and anti-inflammatories. Patient had a follow-up appointment with primary care provider on 09/29/16.  Arm was still red and tender.  Provider scheduled ultrasound for am of 10/03/2016.  Ultrasound revealed multiple blod clots in left arm.  Patient was prescribed warfarin.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Skin redness, tenderness, and warmth around the injection side.
Age: 39.0
Sex: M
Vaccine: FLU4
Symptoms: Generalised erythema, Muscle spasms
Clinical narrative: Muscle cramping, redness all over body.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injected limb mobility decreased, Injection site pain, Rash macular
Clinical narrative: Pain anterior to injection site, difficult lifting arm and, red splotches approximately 6 inches X 3 inches.
Age: 1.0
Sex: F
Vaccine: HIBV, PNC13
Symptoms: Peripheral swelling, Swelling face, Urticaria
Clinical narrative: Hives over entire body; hand, feet and face swelling a few hours after the vaccines were given.
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Hypoaesthesia, Joint injection, Mobility decreased, Pain in extremity, Paraesthesia
Clinical narrative: Arm pain, difficulty lifting arm and numbness/tingling into wrist.
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: X-ray
Clinical narrative: Arm pain, difficulty lifting arm and numbness/tingling into wrist.
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Dyspnoea, Electrocardiogram, Erythema, Pain, Pyrexia
Clinical narrative: Rash the next morning. Gradually got worse with pain/redness and fever. On the 3rd day had problems breathing and went to her work site health clinic. They gave her oxygen and called 911. 911 came, gave her Benadryl and IV ? and took her to ER. ER did EKG.
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Rash
Clinical narrative: Rash the next morning. Gradually got worse with pain/redness and fever. On the 3rd day had problems breathing and went to her work site health clinic. They gave her oxygen and called 911. 911 came, gave her Benadryl and IV ? and took her to ER. ER did EKG.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis
Clinical narrative: 10/03/2016 at 3:40 PM - Cellulitis of right upper extremity.  Prescribed Cephalexin 500 mg.  Take 1 capsule by mouth 3 x per day for 10 days.
Age: 53.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Pain
Clinical narrative: Red dime sized spot on the inside of the arm. Opposite the vaccine administration site. The spot and sore no itching.
Age: 63.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Pruritus, Rash, Swelling
Clinical narrative: Rash and Redness and swelling. Started itching 10/02/2016. She left it alone.
Age: 21.0
Sex: M
Vaccine: FLU4
Symptoms: Dizziness, Loss of consciousness
Clinical narrative: After immunization patient stated he felt lightheaded then passed out in the chair and remained unconscious for approximately 3 minutes.
Age: 69.0
Sex: M
Vaccine: FLUA3
Symptoms: Pruritus, Rash
Clinical narrative: The patient reported itching and rash which did not resolve. He visited the ER today for treatment.
Age: 45.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia, Rash
Clinical narrative: Rash with fever.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Blood aluminium, Fatigue, Headache, Insomnia, Nausea
Clinical narrative: Sore throat, fatigue, headache, nausea, insomnia.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Oropharyngeal pain
Clinical narrative: Sore throat, fatigue, headache, nausea, insomnia.
Age: 46.0
Sex: F
Vaccine: PNC13
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Headache, fever, redness/pain/swelling at injection site.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Feeling abnormal, Flushing, Nausea
Clinical narrative: Within minutes of receiving the vaccine the patient expressed she didn't feel too good. Face became flushed and then she said she felt woozy and nauseous. Breathing was ok but called 911. EMS arrived and checked all vitals which were normal. Flushing, woozy, and nausea resolved within 15-20 min. No meds given.
Age: 60.0
Sex: F
Vaccine: FLU4, PNC13, VARZOS
Symptoms: Injection site discomfort, Injection site erythema, Injection site warmth
Clinical narrative: Redness, discomfort, warm feeling in area of injection approximately 2 inches wide.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Lethargy, Somnolence
Clinical narrative: Per patient's mother, patient was very sleepy and "lethargic" within a few hours of vaccine administration and remained this way for 1 to 2 days. This occurred with 2, 4, and 6 mo vaccines.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Patient described the areas as red, swollen, and hard when touched. She also complain about pain in the area. She visited her primary physician who recommended Benadryl and to put ice over the injection area.
Age: 34.0
Sex: M
Vaccine: FLUX
Symptoms: Axillary pain, Oedema peripheral, Tenderness
Clinical narrative: Less than 24 hours after receiving flu vaccine in R deltoid, had onset of swelling and pain in R axilla. On exam, patient's R axilla was tender and diffusely swollen encompassing an area of approx. 10 cm diameter, without palpable lymphadenopathy. No erythema at injection site nor in axilla. Recommended symptomatic treatment with ibuprofen. Patient reported same reaction after flu shot a year ago: onset of pain and swelling in R axilla after flu shot in R deltoid less than 24 hours after injection. Was seen at urgent care and treated with doxycycline. Swelling resolved after a few days.
Age: 58.0
Sex: F
Vaccine: PNC
Symptoms: Induration, Inflammation, Pruritus, Skin warm
Clinical narrative: Patient said arm was itchy,hot and inflammed. Hard to the touch.
Age: 27.0
Sex: F
Vaccine: FLU4
Symptoms: Eye swelling, Swollen tongue
Clinical narrative: Swollen eyes and tongue upon awaking in AM (about 08:00), self medicated with BENADRYL 25mg cap, CLARITIN 10mg, and ZANTAC 150mg with resolution of symptoms in about 2-4 hours.
Age: 35.0
Sex: F
Vaccine: FLUX
Symptoms: Fatigue, Myalgia
Clinical narrative: Muscle pain, tiredness.
Age: 29.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Injection site redness, swelling of the arm, fever and chills.
Age: 58.0
Sex: F
Vaccine: FLU4, TDAP, FLU4, TDAP
Symptoms: Pruritus, Rash, Skin warm
Clinical narrative: SKIN HOT TO TOUCH/ITCHING/RASH.
Age: 58.0
Sex: F
Vaccine: FLU4, TDAP, FLU4, TDAP
Symptoms: Injection site pruritus, Injection site rash, Injection site warmth
Clinical narrative: SKIN HOT TO TOUCH/ITCHING/RASH.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, IPV, RVX
Symptoms: Abdominal pain upper, Blood test normal, Crying, Diarrhoea, Insomnia
Clinical narrative: Diarrhea.  Severe stomach pain. inconsolable crying arching back.  hitting face. Sleeplessness. Restless.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, IPV, RVX
Symptoms: Laboratory test normal, Opisthotonus, Restlessness, Stool analysis normal, Urine analysis normal
Clinical narrative: Diarrhea.  Severe stomach pain. inconsolable crying arching back.  hitting face. Sleeplessness. Restless.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Neck pain, Nuclear magnetic resonance imaging, Pain, Pain in extremity
Clinical narrative: Pt. complaints of shooting pains up her neck and down her arm.
Age: 8.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Oedema, Peripheral swelling, Skin tightness, Tenderness
Clinical narrative: Left arm swollen, red x 2 days, worsening. Redness all around the left arm and swelling worsening and is getting tight. Tenderness to palpation present, edema present. Sent to hospital and was admitted for IV antibiotics every 6 hours for 24 hours. Discharged 9/16 and sent home on clindamycin for 10 days.
Sex: F
Vaccine: FLU4
Symptoms: Anaphylactic reaction
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of anaphylaxis in a female patient who received FLUARIX QUADRIVALENT. On 28th September 2016, the patient received FLUARIX QUADRIVALENT .5 ml. On 28th September 2016, several minutes after receiving FLUARIX QUADRIVALENT, the patient experienced anaphylaxis (serious criteria GSK medically significant and life threatening). On an unknown date, the outcome of the anaphylaxis was not recovered/not resolved. The reporter considered the anaphylaxis to be almost certainly related to FLUARIX QUADRIVALENT. Additional details were provided as follows: The age at vaccination was not reported. The patient required an emergency visit for anaphylaxis. The healthcare professional did not have product information or date of birth of the patient.
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Rash, hives, itching. Breathing was not involved per patient.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Eyelid oedema, Eyelids pruritus, Pruritus
Clinical narrative: Left upper and lower eyelid slightly swollen with itching. Also, 3 red spots that itch, (1) (R) forearm, (R) abdominal, (L) chest upper.
Age: 16.0
Sex: F
Vaccine: FLU3
Symptoms: Altered state of consciousness, Feeling hot, Hyperhidrosis, Pallor
Clinical narrative: About 10 minutes after the flu shot the patient got hot, sweaty, pale and almost passed out. We laid her down, elevated feet, checked her BP. We also gave her juice and snack when they said she hadn't eaten any lunch.
Age: 69.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Abdominal pain upper, Cellulitis, Headache, Injection site erythema, Injection site swelling
Clinical narrative: Received PREVNAR-13 and FLUZONE HD on 9/16/16 in separate arms. Stated she had a low grade fever, stomach ache, headache for 2 days afterwards, then on 4th day after her injection site where PREVNAR-13 was given because red/swollen/warm. Went to MD  and diagnosed with cellulitis. Given KEFLEX 500mg twice daily.
Age: 69.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site warmth, Pyrexia
Clinical narrative: Received PREVNAR-13 and FLUZONE HD on 9/16/16 in separate arms. Stated she had a low grade fever, stomach ache, headache for 2 days afterwards, then on 4th day after her injection site where PREVNAR-13 was given because red/swollen/warm. Went to MD  and diagnosed with cellulitis. Given KEFLEX 500mg twice daily.
Age: 3.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Injection site swelling, Skin warm, Swelling
Clinical narrative: Left thigh swollen and left inguinal area, swollen, red, warm erythematous.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Diarrhoea, Dysgeusia, Flushing, Injection site warmth, Vomiting
Clinical narrative: Heat at site, chalky taste in mouth, flushed, vomiting, diarrhea.
Age: 78.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Retching
Clinical narrative: The early am (approximately 4 am) pt woke, felt light headed and experienced dry heaves. Report no pain, swelling or redness near injection site.
Age: 3.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: None. No adverse reactions. Gave immunization to 3yr old (only indicated for 4yr and older).
Age: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Headache, Lymphadenopathy, Pain in extremity
Clinical narrative: Patient reported a headache after 1 hour of receiving vaccine. Left arm sore/painful with increased swelling of lymph nodes in axillary area/neck. No fever present. Pt. to f/u with PCP.
Age: 1.0
Sex: F
Vaccine: FLU4, MMR, PNC13, VARCEL
Symptoms: Irritability, Nasopharyngitis, Otitis media, Pyrexia, Rash
Clinical narrative: Rec'd 12 mo imm. 9/19/16 at office during 12 mo. WCE. Seen 9/30/16 for reported s/s: morbilliform rash (pink) to scalp, neck, trunk and ext.  began 9/28/16. Increased fussiness and 'cold s/s' x approximately 2 wks. Tactile fever 9/28 and 9/29/16 eve's. Dx = viral exanthem secondary MMR vac. and BSOM. Observation - PRN Ab if fever or ear pulling next 1-2 days.
Age: 1.0
Sex: F
Vaccine: FLU4, MMR, PNC13, VARCEL
Symptoms: Rash morbilliform, Viral rash
Clinical narrative: Rec'd 12 mo imm. 9/19/16 at office during 12 mo. WCE. Seen 9/30/16 for reported s/s: morbilliform rash (pink) to scalp, neck, trunk and ext.  began 9/28/16. Increased fussiness and 'cold s/s' x approximately 2 wks. Tactile fever 9/28 and 9/29/16 eve's. Dx = viral exanthem secondary MMR vac. and BSOM. Observation - PRN Ab if fever or ear pulling next 1-2 days.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: This spontaneous report was received from a physician via company representative refers to a 15 year old female patient. No pertinent medical history and drug reactions or allergies were reported. On 09-SEP-2016, the patient was vaccinated with GARDASIL (lot, expiry date, dose and frequency were unknown) intramuscularly. No concomitant medications were reported. On 09-SEP-2016, after receiving a dose of GARDASIL, the patient experienced syncope in the physician's office. The patient sought medical attention by contacting physician. The outcome was reported as recovered. The causality assessment was not provided by the reporter. No product quality complaint (PQC) was filed. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to an unspecified number of patients of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB which had lot # M010611 with expiry: 02-JUN-2018, lot # M022077 with 10-MAR-2019 and lot # M023718 with expiry: 09-MAY-2018 (dosing details not provided). The vaccines were exposed to a temperature excursion of 9 degree Celsius for 1 hour 24 minutes, with an additional excursion for 10 degree Celsius for 2 hours for lot # M010611 with expiry: 02-JUN-2018 and lot # M022077 with expiry: 10-MAR-2019. No adverse effects reported. No further information provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Information has been received from a pharmacist concerning a 60 year old female patient. There were no drug reactions and allergies. No pertinent medical history or concurrent conditions were reported. On 21-SEP-2016, the patient was vaccinated with an unspecified dose of ZOSTAVAX at a dose of 65 ml, via subcutaneous route (the frequency was reported as "once") (lot number reported as M026874 with an expiration date of 19-JUL-2017) (strength and anatomical location were not reported). Concomitant therapies included ramipril, AMBIEN, ZANTAC, EFFEXOR, COREG, MIRALAX, PRILOSEC, KLONOPIN and CRESTOR. Other suspect medications were not reported. On 22-SEP-2016 the patient developed redness and itchiness at the ZOSTAVAX injection site, which was also swollen (injection site erythema, injection site swelling and injection site pruritus). On unspecified date in 2016, the patient sought medical attention and she was seen by an unspecified physician in regards to the reaction and was prescribed BACTRIM DS as treatment for the reaction. Laboratory diagnostic studies were not performed. No product quality complaint was involved. At the time of reporting, the outcome of injection site erythema, injection site swelling and injection site pruritus was unknown. The relatedness between the events and therapy with ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 30-SEP-2016, the patient was vaccinated with improperly stored ZOSTAVAX, expiry date 27-JUL-2017 (dose, route and site of administration and lot # were not provided). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Licensed Vocational Nurse and refers to an unspecified patients of unknown age and gender. There was no information about the patient's current condition, concomitant therapies or medical history provided. On an unknown date, the patients were vaccinated with an improperly stored dose of ZOSTAVAX lot # L023118 with and expiration date:24-SEP-2016 (dose, frequency and route of administration were not reported). No adverse effects were reported. This is one of several reports received from the same reported. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a company representative refers to a 73 year old male patient, the reporter's father. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date (reported as 6 to 7 years ago), the patient was vaccinated with ZOSTAVAX vial (dose, route of administration, lot # and expiration date were not reported). On an unknown date, the patient developed shingles which was considered a breakthrough by the reporter. The outcome of the event was unknown. The relatedness between the event and ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age and gender. No medical history and concurrent conditions were reported. On an unknown date in 2013 the patient was vaccinated with a dose of ZOSTAVAX (lot number and expiry date unknown) (dosing regimen and frequency unknown) subcutaneously. No concomitant medications were reported. On an unknown date in 2014 and on 26-SEP-2016 the patient was again vaccinated with doses of ZOSTAVAX, (lot number and expiry date unknown) (dosing regimen and frequency unknown) subcutaneously. It was reported that all the 3 doses of ZOSTAVAX were administered by three separate physicians. No adverse effects were reported. The action taken with the therapy with ZOSTAVAX was unknown. The outcome of the events was unknown. There was no product quality complaint reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown ages and genders. The patients' medical history was not reported. On unknown dates the patients were vaccinated with improperly stored doses of MMR II albumin status rHA (route and dosage unknown; lot # M004899, EXP 27-JAN-2018). No adverse event was reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: F
Vaccine: HEPAB
Symptoms: Fall, Syncope
Clinical narrative: This case was reported by a pharmacist via other and described the occurrence of fainting in a female patient who received Hepatitis A and Hepatitis B vaccine. On 13th September 2016, the patient received Hepatitis A and Hepatitis B vaccine. In September 2016, less than a week after receiving Hepatitis A and Hepatitis B vaccine, the patient experienced fainting and fall. On an unknown date, the outcome of the fainting and fall were unknown. It was unknown if the reporter considered the fainting and fall to be related to Hepatitis A and Hepatitis B vaccine. Additional details were provided as follows: This case was reported by a pharmacy via a pharmacy claims management company. The age at vaccination was not reported. The patient experienced fainting resulting in fall after vaccination with Hepatitis A and Hepatitis B vaccine. The patient sought medical attention.
Age: 0.5
Sex: M
Vaccine: DTAP
Symptoms: Adverse event
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of adverse event in a 6-month-old male patient who received DTaP. On an unknown date, the patient received DTaP vaccine. On an unknown date, an unknown time after receiving DTaP vaccine, the patient experienced adverse event. On an unknown date, the outcome of the adverse event was unknown. It was unknown if the reporter considered the adverse event to be related to DTaP vaccine. Additional details were provided as follows: The mother of the patient reported that her son received DTaP vaccine when he was 6 months old and he had a reaction. The patient's mother was not sure what he was vaccinated with. So, they held off on getting him any other vaccine, but he was 4 years old at the time of reporting and they are trying to get him caught up on vaccines for school. They went to the doctor a day before reporting date and the patient was vaccinated with KINRIX (see case US2016139353).
Age: 5.0
Sex: M
Vaccine: MMR
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: (R) arm redness warm to touch.
Age: 0.75
Sex: M
Vaccine: DTAPHEPBIP, PNC13
Symptoms: Rash
Clinical narrative: Rash.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Urticaria
Clinical narrative: Pt received Tdap yesterday at clinic. Pt stated she developed hives to face and extremities, no difficulty breathing or resp distress.
Age: 71.0
Sex: M
Vaccine: PNC13
Symptoms: Joint injection, Skin lesion
Clinical narrative: 7/7/16 Vaccine negated effects of recent lesi and hip steroid injection. (7/21/16).
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Haematochezia, Irritability
Clinical narrative: Crankiness and gross blood in stools.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 59 year old female patient (reporter's wife). The patient's concurrent condition included rheumatoid arthritis. On an unknown date, the patient was vaccinated with ZOSTAVAX (dose, frequency and route of administration were not reported). The patient was taking an unspecified medication for rheumatoid arthritis. On an unknown date, about a week after vaccination, pharmacist's wife developed rash around injection site. Rash did not spread to any other parts of body and rash subsided within a couple of days without any treatment on an unknown date. The patient did not seek medical attention. Causality assessment was not reported. Additional information has been requested.
Sex: F
Vaccine: HPV9
Symptoms: Maternal exposure before pregnancy, Pregnancy test positive
Clinical narrative: This spontaneous prospective pregnancy report as received from a registered nurse refers to a female patient of unknown age. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient was vaccinated with a dose of GARDASIL 9 (lot # and expiration date was not reported) despite being pregnant. The nurse noted that prior to receipt of the dose of GARDASIL 9 a pregnancy test showed negative, therefore patient was administered the vaccine. On an unknown date, another pregnancy test was conducted after receipt of the vaccine which showed positive. The patient's Last Menstruation Period (LMP) and Estimated Delivery Date (EDD) were not reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to multiple unspecified patients of an unknown age and gender. Information regarding the patients' pertinent medical history, drug reactions/allergies and concomitant medications was not reported. On unknown dates, the patients were vaccinated with improperly stored ZOSTAVAX (lot number, expiration date, dose and route of administration were not reported). No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report was received via a company representative from a physician and a licensed practical nurse regarding a non-pregnant female patient of unknown age. In approximately 2015 (reported as "about a year ago"), the patient received PREVNAR 13. On an unknown date in September 2016 (reported as "on an unspecified day this week"), the patient came in and received PNEUMOVAX 23 (lot#, expiration date, dose and route of administration were not reported). After an unspecified time, in September 2016, the patient called the office and stated "I have redness, soreness and swelling where I received my shot". The outcome of the events and causality assessment were not reported. Additional information has been requested.
Age: 7.0
Sex: M
Vaccine: TDAP
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Developed large, red, swollen area approx. 4-5 cm, hot to touch. Ice was applied by parent, resolved in 2-3 days.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker concerning an unknown number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patients were vaccinated with (Oka/Merck) VARIVAX, lot # M010484, expiration date: 01-MAR-2018, (strength, dose and route of administration were unknown), which were improperly stored. No adverse effects were reported and no product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.8
Sex: U
Vaccine: HIBV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 9 month old patient of unknown gender. The patient's concurrent conditions and medical history were not reported. On 29-SEP-2016, the patient was inadvertently vaccinated with a third dose of PEDVAXHIB (strength, dose, frequency, route of administration, lot number and expiration date were unknown). There were no concomitant therapies nor adverse effects reported. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown ages and genders. The patients' medical history was not reported. On unknown dates, the patients were vaccinated with  improperly stored doses of VAQTA (route and dosage unknown;lot # M002268 EXP 20-SEP-2017). No adverse event was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: This spontaneous report as received from a pharmacist via company representative refer to a non pregnant female patient of unknown age. Patient's medical history and concurrent conditions were unknown. On 08-SEP-2016 the patient was vaccinated with ZOSTAVAX (dose, frequency and route of administration were not reported in unspecified arm). Concomitant therapies were unknown. On 09-SEP-2016, patient came back into pharmacy with complaint of injection site: entire backside of her arm was red and painful. Pharmacist did not state that redness was a rash, therefore breakthrough varicella, could not be ruled out. No treatment was given for adverse events. The outcome of events was unknown. Causality assessment was not reported. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a 71 year old male patient. The patient's medical history included hernia operation in abdomen area. On an unknown date in 2010 (reported as "about 5 or 6 years ago"), the patient received ZOSTAVAX, (route: subcutaneous) in the left arm. The patient's concomitant therapies included PRINIVIL as blood thinner and HYZAAR as water pill. The patient had shingles every year after that. He also mentioned that he had gotten the shingles on his head, arms and chest and this year he got it on his face. He also stated that he sought medical attention the first year he got the shingles and they advised to use AIDANCE Skin Care for shingles and an unspecified antibiotic he did not have the name. The outcome and causality of the events were unknown. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concomitant medication were not provided. On 13-SEP-2016, the patient was vaccinated with improperly stored PNEUMOVAX 23 (lot # L019835, expiration date 23-MAR-2016; dose and route were unknown). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 63.0
Sex: M
Vaccine: TDAP
Symptoms: Lethargy, Neck pain, Pain in extremity
Clinical narrative: Patient states 3 days post vaccination lethargic, neck pain, right arm sore.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # L037554, expiration date 25-DEC-2017, lot # L026602, expiration date 19-OCT-2017, lot # L024993, expiration date 17-OCT-2017, lot # M017983, expiration date 30-MAY-2018 (exact dose and route of administration were not reported). There was no adverse effect reported. These doses of GARDASIL 9 were exposed to 51 degrees Fahrenheit for 2 hours 30 minutes, 47.9 degrees Fahrenheit for 5 hours 20 minutes, 33 degrees Fahrenheit for 6 hours 50 minutes, and 47.6 degrees Fahrenheit for 20 minutes. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ lot # L048854, expiration date 31-AUG-2017, lot # reported as L035637, expiration date 09-JUN-2017, lot # M007124, expiration date 05-OCT-2017, lot # M019708, expiration date 25-OCT-2017 (exact dose was not reported, orally). There was no adverse effect reported. These doses of ROTATEQ were exposed to 51 degrees Fahrenheit for 2 hours 30 minutes, 47.9 degrees Fahrenheit for 5 hours 20 minutes, 33 degrees Fahrenheit for 6 hours 50 minutes, and 47.6 degrees Fahrenheit for 20 minutes. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Smear cervix abnormal
Clinical narrative: This spontaneous report was received from a female patient of an unknown age and refers to herself. No information on the patient's concurrent conditions, pertinent medical history, drug reactions or allergies was reported. On an unknown date in approximately 2012 (reported as "about 4 years ago") the patient was vaccinated with GARDASIL (dose, route of administration, anatomical location, lot number and expiration date were not reported). On an unknown date (reported as "recently"), the patient had an unusual Papanicolaou smear (PAP). The outcome of the event was unknown. The relatedness between the event and the GARDASIL was not reported. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Accidental exposure to product, Device difficult to use, No adverse event
Clinical narrative: This spontaneous report was received from a male pharmacist of unknown age, reporting on himself. On an unknown date, while administrating ZOSTAVAX (19400 PFU, lot # L040445 and expiry:15-JAN-2017) to an unknown patient, the pharmacist had a difficult time withdrawing a needle and some of the vaccine got on to his cheekbone and face. The pharmacist did not think that the vaccine got into his eye. He washed his face and wiped the area with alcohol wipes. Later, the patient did receive the full dose of ZOSTAVAX. No adverse effects and no product quality complaint (PQC) reported. No further information provided. Additional information has been requested.
Age: 12.0
Sex: U
Vaccine: HPV9
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 information regarding the patients' medical history and concurrent conditions was provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 injection, lot # M020103, expiration date: 14-FEB-2018, (dose, dose number, route of administration and injection site were not provided). There were no concomitant medications reported. It was stated that the vaccine underwent a temperature excursion of -0.3 degrees Celsius for 22 hours. The temperature excursion was captured using digital data logger. No previous temperature excursion was reported. No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Antibody test, Therapy non-responder
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a patient of unknown age and gender. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On an unknown dates, the patient was vaccinated with all the 3 doses of RECOMBIVAX HB (dosing details, lot# and expiry date were not reported) but the patient did not seroconvert. On an unknown date, titers were done but the result was unknown. No treatment was given for the event. The patient did not seek any medical attention. The outcome of 'did not seroconvert' was unknown. The reporter did not provide the causality between the event and the suspect therapy. There were no product quality complaints (PQC) involved. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to two patients of unknown age and gender. The patients' concurrent conditions and medical history were not reported. On an unknown date, the patients' were vaccinated with ZOSTAVAX (dose, route, lot # and expiry date unknown). No concomitant medication was reported. On an unknown date, the patients' experienced redness and swelling around injection site after receiving vaccination. No treatment was provided for the event and the patient did not seek any medical attention. The pharmacist reported that he had performed a lot of ZOSTAVAX vaccinations and he remembered these two patients complaining of swelling and redness around the injection site. Product quality complaint was not involved. The outcome of injection site redness and injection site swelling was unknown. Causality assessment was not provided by the reporter. Additional information has been requested.