chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.38
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 4 months old patient of unknown gender. No information on patient's medical history or concurrent conditions was provided. On 02-JAN-2015, the patient was vaccinated with the dose of PEDVAXHIB lot # K008874 (dose, strength, route of administration and expiration date were not reported) which had a temperature excursion. No information on patient's concomitant medication was provided. No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: HPVX
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from the mother of a female patient of unknown age. The concurrent condition and medical history was not reported. On an unknown date, the patient was vaccinated with all the 3 doses of GARDASIL or GARDASIL 9 (the reporter was not sure which was vaccine was administered). The concomitant medication was not reported. On an unknown date the patient was accidentally vaccinated with the fourth dose of GARDASIL or GARDASIL 9 somewhere between 6 and 18 months after the third dose (extra dose administered). No adverse effects were reported. Additional information is not expected as no HCP details are available.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. The patients' medical history and current conditions were not provided. On an unknown dates, the patients were vaccinated with a doses of an improperly stored GARDASIL (lot #, expiration date, route and dose were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
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 (gender/age unknown). The patients' concurrent/historical conditions or concomitant therapies were not reported. On unknown dates, since 20-APR-2015 the patients were vaccinated with PEDVAXHIB (lot # J016188, exp. date 02-OCT-2016) (dose and route were not reported), which was exposed to temperatures outside of the recommended range. No adverse effect had been reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse referring to a patient of unknown age and gender. There was no pertinent medical history or drug allergies/drug reactions reported. On an unknown date the patient was vaccinated with the first and second dose of GARDASIL (Lot # and expiration date unknown), dose and route of administration were not reported. It was also reported that on an unspecified date that the patient was vaccinated with the third dose of GARDASIL 9 (Lot # and expiration date unknown), dose and route of administration were not reported. No adverse events were reported. Additional information has been requested.
Age: 84.0
Sex: F
Vaccine: PNC13
Symptoms: Cellulitis, Diarrhoea, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Redness, swelling and itching at injection site gradually appearing after 6/25. Seen at UC on 7/2, given antibiotics for cellulitis. Rash resolved (nearly) at follow-up appointment on 7/6/15. ABX d/c'd on 7/5 due to diarrhea.
Age: 84.0
Sex: F
Vaccine: PNC13
Symptoms: Rash
Clinical narrative: Redness, swelling and itching at injection site gradually appearing after 6/25. Seen at UC on 7/2, given antibiotics for cellulitis. Rash resolved (nearly) at follow-up appointment on 7/6/15. ABX d/c'd on 7/5 due to diarrhea.
Age: 16.0
Sex: F
Vaccine: TD
Symptoms: Erythema, Oedema, Pain in extremity, Peripheral swelling, Swelling
Clinical narrative: 7/2/15 Pain in rt arm, redness 1 hr after injection which increased daily-swelling leg 2nd day. 7/3/15 Pt called clinic advised ice & elevation with ibuprofen for pain 500 mg tid. 7/4-7/7 pt c/o increased pain edema & swelling. 7/7/15 pt came in for evaluation and treatment. Photos taken prednisone 4mg dose pack given.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to a patient of unknown age and gender who on 08-APR-2015 was vaccinated with an improperly stored dose of oral, ROTATEQ lot # K011663 (route was not provided). The excursion time for this lot was 36 hours. No adverse effects had been observed or reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 40.0
Sex: F
Vaccine: PPV
Symptoms: Impaired work ability, Injection site pain, Injection site swelling, Lymphadenopathy, Nausea
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a 40 year old female patient with gastrooesophageal reflux disease and hyperlipidaemia. The patient was not pregnant. The patient did not have any drug reactions and allergies. On 01-JUL-2015, the patient was vaccinated with PNEUMOVAX 23 lot # K021030, expiry date 22-JUN-2016, dose 0.5 ml, intramuscular in the right arm. Concomitant therapies included estradiol (manufacturer unknown). On 01-JUL-2015, shortly after receiving the vaccine, the patient experienced fever rating between 101 F to 102.8F, nausea, vomiting, swelling and tenderness at the site of injection in right upper deltoid. On 02-JUL-2015, while the patient was examined by the physician assistant, the patient had reactive lymph nodes under the left arm. The patient was treated with an unspecified dose of ZOFRAN. White blood cell count test was performed but no result was provided. The patient did not recover from adverse events at the time of this report. Causality assessment was not provided. On 02-JUL-2015, the patient was not able to work as a result of adverse events. Upon internal review the events of fever rating between 101F to 102.8F, nausea, vomiting, swelling and tenderness at the site of injection and reactive lymph nodes under the left arm were considered as disabling. Additional information has been requested.
Age: 40.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia, Vomiting, White blood cell count
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a 40 year old female patient with gastrooesophageal reflux disease and hyperlipidaemia. The patient was not pregnant. The patient did not have any drug reactions and allergies. On 01-JUL-2015, the patient was vaccinated with PNEUMOVAX 23 lot # K021030, expiry date 22-JUN-2016, dose 0.5 ml, intramuscular in the right arm. Concomitant therapies included estradiol (manufacturer unknown). On 01-JUL-2015, shortly after receiving the vaccine, the patient experienced fever rating between 101 F to 102.8F, nausea, vomiting, swelling and tenderness at the site of injection in right upper deltoid. On 02-JUL-2015, while the patient was examined by the physician assistant, the patient had reactive lymph nodes under the left arm. The patient was treated with an unspecified dose of ZOFRAN. White blood cell count test was performed but no result was provided. The patient did not recover from adverse events at the time of this report. Causality assessment was not provided. On 02-JUL-2015, the patient was not able to work as a result of adverse events. Upon internal review the events of fever rating between 101F to 102.8F, nausea, vomiting, swelling and tenderness at the site of injection and reactive lymph nodes under the left arm were considered as disabling. Additional information has been requested.
Age: 25.0
Sex: M
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 25 year old male patient. The patient's pertinent medical history was not reported. On 06-JAN-2015, the patient was vaccinated with first dose of GARDASIL (dose, frequency and route were not reported) and the second dose was administered on 23-MAR-2015 (Inappropriate schedule of drug administration). No adverse effects were reported. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: FLU3, HPV4, MNQ, VARCEL
Symptoms: Dyskinesia, Dyspnoea, Electroencephalogram, Nuclear magnetic resonance imaging, Seizure like phenomena
Clinical narrative: Went to bed @ 0400. Woke up shaking. 11/08/14 She was observed to be shaking/jerking in her sleep. Was making throaty/gasping sounds, unable to wake her up while this was happening. Looked like a seizure.
Age: 13.0
Sex: F
Vaccine: FLU3, HPV4, MNQ, VARCEL
Symptoms: Somnolence, Tremor
Clinical narrative: Went to bed @ 0400. Woke up shaking. 11/08/14 She was observed to be shaking/jerking in her sleep. Was making throaty/gasping sounds, unable to wake her up while this was happening. Looked like a seizure.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: The injection site started to ache and swell about 4 hours after administration. Patient took Benadryl and Ibuprofen over the counter and also iced the area. The swelling started to subside. She came by the pharmacy 6/3015 around 12pm and her arm was still swollen but the swelling was decreasing per patient.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Loss of consciousness
Clinical narrative: Approx. 10 minutes after receiving vaccine pt passed out and became unconscience for approx 1 minute.
Age: 12.0
Sex: M
Vaccine: HPV4
Symptoms: Feeling abnormal, Injection site reaction
Clinical narrative: 1230 pm, pt c/o R arm where imm given felt like "could not pick things up".  No numbness or tingling, but yes "felt funny".  Denied pain.  Exam normal tone, symmetric movements, shoulder abd/adduction.  Sensation intact light touch, strength 5/5, fingers normal ROM, normal finger opposition/strength thumb/2nd and thumb/5th digit B.  Felt "better" after a few minutes.  Discussed with dad observe, can try ibuprofen if complains of arm sore, if weakness/funny feeling returns, or if any sxms or concerns to call asap.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Urticaria
Clinical narrative: Developed urticaria between 6/30 and 7/2-not clear that it was within 24 h of imms.
Age: 22.0
Sex: F
Vaccine: HEP
Symptoms: Muscle rigidity, Posture abnormal, Seizure like phenomena, Staring
Clinical narrative: Pt exhibited seizure-like symptoms following vaccine. Turned head to right side, with fixed grimace-like facial expression, remained seated and in fixed position with muscle rigidity; episode lasted 30 sec., approximately. Immediate return to prior level of functioning.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site bruising, Rash
Clinical narrative: Bruise at site of injection. Rash (2 inch diameter) below site of inject.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Gait disturbance, Guillain-Barre syndrome, Incontinence, Muscle atrophy
Clinical narrative: Sx of weakness, difficulty with ambulation, muscle atrophy, pain with minimal muscle movement, starting in lower extremities and spreading to arms, shoulders, chest and back. Difficulty with sphincter control; sx consistent with Guillain-Barre Syndrome. Pt. continues with sx.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Sx of weakness, difficulty with ambulation, muscle atrophy, pain with minimal muscle movement, starting in lower extremities and spreading to arms, shoulders, chest and back. Difficulty with sphincter control; sx consistent with Guillain-Barre Syndrome. Pt. continues with sx.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash erythematous, Swelling
Clinical narrative: Red rash, itching and swelling.
Age: 1.25
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Pyrexia, Urticaria, Vomiting
Clinical narrative: Patient received INFANRIX and PEDVAXHIB on 6/24/15 around 10:30 AM. Around bedtime patient developed fever. During the night, the patient vomited 2 times. Hives were noticed when patient awoke on 6/25/15.
Age: 18.0
Sex: M
Vaccine: HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: We believe that the VARIVAX was inadvertently mixed with MENACTRA instead of the diluent. 7-7-15 Nurse spoke with patient. No adverse effects noted.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Blood test, Burning sensation, Electromyogram, Hypoaesthesia, Injection site pain
Clinical narrative: Pain/Aching/Burning sensation in upper left arm, traveling down arm into elbow and wrist. Tingling and numbness in fingers. Pain going into shoulder and into shoulder blade, pain also sometimes going through armpit and left side of upper body. Have had several sets of x-rays, EMG test, cortisone shot.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Paraesthesia, Ultrasound scan, X-ray
Clinical narrative: Pain/Aching/Burning sensation in upper left arm, traveling down arm into elbow and wrist. Tingling and numbness in fingers. Pain going into shoulder and into shoulder blade, pain also sometimes going through armpit and left side of upper body. Have had several sets of x-rays, EMG test, cortisone shot.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Pallor, Seizure, Tremor
Clinical narrative: Patient was witnessed by parents convulsing-eg shaking of extremities, facial pallor that lasted for 15 sec. after HPV was given.
Age: 75.0
Sex: M
Vaccine: PNC13
Symptoms: Abasia, Muscular weakness, Pain
Clinical narrative: Extreme weakness in all muscles & pain. Unable to walk 1st 2 days. Leg muscles still not right 7 days later. Pain slowly subsiding. (Had regular pneumonia vaccine Nov, 2013).
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Syncope
Clinical narrative: After vaccine, pt fainted for a few seconds. Head drooped down. Pt positioned on floor lying down. Called 911 immediately. EMS arrived, monitored vitals, they were normal. BP: 113/78, HR 95/105 Sat 100%.
Age: 0.82
Sex: F
Vaccine: HEP
Symptoms: Full blood count, Pyrexia, Streptococcus test negative
Clinical narrative: Vaccine given 1148 AM 6/30/15-woke with fever 101-seen today at 5 pm-T 102.
Age: 58.0
Sex: M
Vaccine: PNC13
Symptoms: Erythema, Fatigue, Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: C/o redness, swelling & hardness-on (L) deltoid 1 hour after receiving vaccine. C/o some fatigue w/in 24 hours. Pt notified 6/29/15 & was seen. C/o tenderness, slight redness, & tingling
Age: 58.0
Sex: M
Vaccine: PNC13
Symptoms: Paraesthesia, Tenderness
Clinical narrative: C/o redness, swelling & hardness-on (L) deltoid 1 hour after receiving vaccine. C/o some fatigue w/in 24 hours. Pt notified 6/29/15 & was seen. C/o tenderness, slight redness, & tingling
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Chest pain, Dyspnoea, Electrocardiogram normal, Feeling abnormal, Myalgia
Clinical narrative: Patient had a well child visit with vaccines given on June 24th. About 3-4 hours later while playing she experienced chest pain & SOB. Was seen in the ER, given nebulizer treatment. EKG, sent home. The next day had sore muscles and had slow speech, seemed out of it. Was seen in the ER, was told patient was fine and sent home.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Speech disorder
Clinical narrative: Patient had a well child visit with vaccines given on June 24th. About 3-4 hours later while playing she experienced chest pain & SOB. Was seen in the ER, given nebulizer treatment. EKG, sent home. The next day had sore muscles and had slow speech, seemed out of it. Was seen in the ER, was told patient was fine and sent home.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site cellulitis, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: The area of the vaccine administrated is red, hot and swollen. No fever.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: PHN spoke with mom today 7/1/15 and explained that had administered an extra MENACTRA and BOOSTRIX. Asked mom if patient showing any signs of feeling ill or feeling different in any way. Mom stated patient had been playing & running around like she always does-like normal.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous reprot as received from a health care professional refers to a patient of unknown age and gender who on 10-APR-2015 was vaccinated with an improperly stored dose of oral, ROTATEQ lot # K011663 (dose and route were not provided) which were exposed to 12 hours excursion. No adverse effects had been observed or reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 30.0
Sex: M
Vaccine: SMALL
Symptoms: Injection site erythema, Injection site pruritus, Injection site ulcer
Clinical narrative: Pt received smallpox vaccine approximately 6/19/15. Came to clinic 7/4/15 with ulcerated area, redness itching to left deltoid at injection site. Pt was treated with KEFLEX 500mg 1 tab 3 times a day for 10 days.
Age: 0.19
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Crying, Injection site reaction, Local reaction
Clinical narrative: Mother arrived back at our office with child who was crying inconsolably for +3 hrs. Child has a local reaction to (L) thigh. Given MOTRIN in office & steroid cream.
Age: 1.43
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Blister, Herpes zoster, Pain, Rash, Rash erythematous
Clinical narrative: Dr diagnosed her with shingles. Red, rash appearance, bumps/blisters all down left arm, even on top of hand, palm, and between fingers.
Age: 1.43
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Blister, Herpes zoster, Rash erythematous
Clinical narrative: Dr diagnosed her with shingles. Red, rash appearance, bumps/blisters all down left arm, even on top of hand, palm, and between fingers.
Age: 11.0
Sex: F
Vaccine: MNQ, TYP, MNQ
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Swelling began about 1600hrs, followed shortly by itching. (L) deltoid. C/O itching/soreness during night. Pain/soreness 4/10, itching 4/10. Limited ROM, abducts Kw/ difficulty. Erythema 45 x 105 cm. No at-home remedies attempted.
Age: 11.0
Sex: F
Vaccine: MNQ, TYP, MNQ
Symptoms: Injection site pruritus, Injection site swelling
Clinical narrative: Swelling began about 1600hrs, followed shortly by itching. (L) deltoid. C/O itching/soreness during night. Pain/soreness 4/10, itching 4/10. Limited ROM, abducts Kw/ difficulty. Erythema 45 x 105 cm. No at-home remedies attempted.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Asthenia, Blood test normal, Fatigue, Headache, Hypersomnia
Clinical narrative: Headache and feeling unwell the first 24 hours, followed by very high fever that lasted for 2 weeks.  Had to use Tylenol and Motrin together to keep the fever down, which never reached below 100.  Visited pediatrician 3 times during the two week period, having blood drawn twice and urine tested.  Nothing abnormal found.  At the pediatrician's office, her temp as so high they recommend we go to the ER.  Went to the ER and temp was 105.6 when she was admitted.  Had more blood drawn and urine tested.  Nothing abnormal found for any of the tests.  While in the ER she was given IV fluids before being sent home.  Was so tired that she couldn't keep her eyes open, sleeping for all but 3 hours during a 24 hour period.  This lasted for 3 days.  After 14 days, her fever finally broke, yet she had a hard time staying awake and was extremely weak for another 3 days.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Malaise, Pyrexia, Urine analysis normal
Clinical narrative: Headache and feeling unwell the first 24 hours, followed by very high fever that lasted for 2 weeks.  Had to use Tylenol and Motrin together to keep the fever down, which never reached below 100.  Visited pediatrician 3 times during the two week period, having blood drawn twice and urine tested.  Nothing abnormal found.  At the pediatrician's office, her temp as so high they recommend we go to the ER.  Went to the ER and temp was 105.6 when she was admitted.  Had more blood drawn and urine tested.  Nothing abnormal found for any of the tests.  While in the ER she was given IV fluids before being sent home.  Was so tired that she couldn't keep her eyes open, sleeping for all but 3 hours during a 24 hour period.  This lasted for 3 days.  After 14 days, her fever finally broke, yet she had a hard time staying awake and was extremely weak for another 3 days.
Age: 16.0
Sex: F
Vaccine: TYP, YF
Symptoms: Cough, Paraesthesia, Rash, Urticaria, Wheezing
Clinical narrative: Tingling in the throat; cough, wheeze, rash; hives.
Age: 56.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Pain, Pain in extremity, Peripheral swelling
Clinical narrative: Patient complaining of L arm pain/swelling since yesterday.  Denies known injury.  Full ROM however when lifing arm up/out c/o increase in pain.
Age: 56.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Abscess drainage, Local swelling, Pain, Purulent discharge
Clinical narrative: Patient complaining of L arm pain/swelling since yesterday.  Denies known injury.  Full ROM however when lifing arm up/out c/o increase in pain.
Age: 43.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Erythema, Induration, Pain
Clinical narrative: Presented 07/03/15 2115, c/o LUE redness and induration, throbbing pain 8/10 with onset 07/01/2015. Administered Keflex and Bactrim 07/03/15 @ 2145 and released to housing unit. 07/04/15 reassessement with significant decrease in erythema and induration on LUE.
Age: 36.0
Sex: F
Vaccine: TDAP
Symptoms: Diarrhoea, Exposure during pregnancy, Hypoaesthesia, Hypoaesthesia oral, Injection site mass
Clinical narrative: Pt called within 5 minutes of leaving, she experienced tingling, and numbing on left side of face.  Pt took a Benadryl orally, she stated she has had allergic reactions previously to other medications.  Pt went to ER, Labor and Delivery and was admitted when her tongue began to swell, tingling and numbing.  After discharge pt expeirenced diarrhea and lump at injection site.
Age: 36.0
Sex: F
Vaccine: TDAP
Symptoms: Laboratory test, Paraesthesia, Paraesthesia oral, Swollen tongue
Clinical narrative: Pt called within 5 minutes of leaving, she experienced tingling, and numbing on left side of face.  Pt took a Benadryl orally, she stated she has had allergic reactions previously to other medications.  Pt went to ER, Labor and Delivery and was admitted when her tongue began to swell, tingling and numbing.  After discharge pt expeirenced diarrhea and lump at injection site.
Age: 54.0
Sex: M
Vaccine: PPV
Symptoms: Muscle tightness, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Left arm swelling, pain, warm, muscle tightness. 80 mg of Depo Medrol given IM.
Age: 37.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injected limb mobility decreased, Musculoskeletal pain, Pain in extremity
Clinical narrative: Severe shoulder pain unable to lift my arm over head or lay on my arm pain still continues.
Age: 37.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Mobility decreased, Musculoskeletal pain, Pain in extremity
Clinical narrative: Severe shoulder pain unable to lift my arm over head or lay on my arm pain still continues.
Age: 1.26
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Crying, Dysstasia, Emotional distress
Clinical narrative: Son became extremely upset crying and would no longer stand on leg where vaccine was administered.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal distension, Insomnia, Nightmare, Urine abnormality
Clinical narrative: Patient called today (7/7/15) to report that following the shot she experience: "cloudy urine, abdominal bloating, nightmares and trouble sleeping" she did not seek medical attention immediately but has been experiencing these symptoms have been fleeting since then.
Age: 14.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site swelling, Swelling
Clinical narrative: Swelling redness and pain of left arm at site, then progressed to swelling and redness of left jaw.
Age: 66.0
Sex: M
Vaccine: TD
Symptoms: Wrong drug administered
Clinical narrative: Wrong vaccine was given. Tdap was requested and Td was given.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Local reaction
Clinical narrative: Pt came two days later and notified the pharmacy that there was a slight localized reactions at the site of injection. Pt felt perfectly fine and no other side effects. Just itching and swelling and redness, which was almost gone when pt stopped by two days later.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injected limb mobility decreased, Injection site swelling
Clinical narrative: Pt came two days later and notified the pharmacy that there was a slight localized reactions at the site of injection. Pt felt perfectly fine and no other side effects. Just itching and swelling and redness, which was almost gone when pt stopped by two days later.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Wrong technique in drug usage process
Clinical narrative: Patient given Menveo with different diluent.
Age: 63.0
Sex: F
Vaccine: TD
Symptoms: Wrong drug administered
Clinical narrative: Tdap was requested. Td was given.
Age: 1.01
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Pyrexia, Rash macular
Clinical narrative: Fever followed by macular rash 2 days later.
Age: 68.0
Sex: M
Vaccine: UNK
Symptoms: Cough
Clinical narrative: Mild spasmodic cough.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Lymphadenopathy, Nausea, Pain, Pain in jaw
Clinical narrative: Nausea; swollen glands; body aches; headache; jaw pain when talking.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Injection site warmth, Pain, Pain in extremity, Pruritus
Clinical narrative: Burning pain in foot, swelling and heat at injection site followed with a Zoster like vesicular rash and itching by 07/06/15.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: Burning pain in foot, swelling and heat at injection site followed with a Zoster like vesicular rash and itching by 07/06/15.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Injection site erythema, Injection site pruritus, Pyrexia, Vaccination site swelling
Clinical narrative: Vaccine site (L arm) red, very swollen x5 days, hot to the touch, itchy. High temperature of 102 x2 days. All joints ached for several days. Resolved 7/6/15.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Vaccination site warmth
Clinical narrative: Vaccine site (L arm) red, very swollen x5 days, hot to the touch, itchy. High temperature of 102 x2 days. All joints ached for several days. Resolved 7/6/15.
Age: 12.0
Sex: F
Vaccine: VARCEL
Symptoms: Abdominal pain, Muscular weakness
Clinical narrative: Weakness in legs, crampy feeling below sternum.
Age: 51.0
Sex: F
Vaccine: PNC13, TDAP
Symptoms: Rash
Clinical narrative: PER PROVIDER PT HAD RASH IN LEFT ARM OVER 30 MM.
Age: 4.0
Sex: M
Vaccine: VARZOS
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: NO ADVERSE EFFECT NOTED AS OF TODAY 7-7-15.
Age: 22.0
Sex: F
Vaccine: TDAP
Symptoms: Activities of daily living impaired, Mobility decreased, Pain in extremity
Clinical narrative: Patient says her arm was hurting she could barely lift her arm up yesterday and her whole arm was hurting. She was having a hard time washing her hair and lifting her arm up to change clothes.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: Redness, swelling and rash below injection site.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Amnesia, Blood test, Feeling abnormal, Head discomfort
Clinical narrative: Patient states head feels heavy, short term memory loss, has no concept of himself/car moving while driving, doesn't feel himself.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Decreased appetite, Lethargy, Pyrexia, Rash
Clinical narrative: Fever, lethargy, loss of appetite, rash on trunk and face.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare professional refers to an unspecified number of patients. In approximately 2015 (reported as since 13-MAR-2015), the patients were vaccinated with doses of ROTATEQ lot # K010221, K011663, K016313 and lot # reported as K015816 (expiration dates, dose, route and site of administrations were not reported) that were exposed to temperatures outside of the recommended range. No adverse effects had been observed or reported. This is one of several reports from the same reporter. Follow up information has been received from the medical assistant on 02-JUL-2015 regarding the patient of an unknown age and gender who on 04-JUN-2015 was vaccinated with a dose of oral, ROTATEQ (lot number K016313) (dose and route were not provided). There were 87 hours excursion. This lot number was received on 08-APR-2015. Additional information is not expected as all correspondence was received.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health care professional refers to a patient of unknown age and gender who on 13-APR-2015 was vaccinated with an improperly stored dose of ROTATEQ lot # K011663 which was under 12 hours excursion. No adverse effects had been observed or reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV9, MENB, PNC13, VARCEL
Symptoms: Herpes zoster
Clinical narrative: Shingles after chickenpox vaccination last week. Tx acyclovir 80mg tab and acyclovir 5% external ointment.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous reprot has been received from a registered nurse referring to a patient of unknown gender and age. No concurrent or medical history was reported. On 29-MAY-2015 the patient was vaccinated with an improperly stored dose of VARIVAX (Merck) dose, route, frequency and anatomical location were unknown (lot number reported as J013278). No adverse event was reported. No further information was provided. No product quality complaint was reported. Lot number J013278 is an invalid lot number for VARIVAX (Merck). This is one of two cases received from the same source (#MARRS 1506USA012931). Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare professional refers to an unspecified number of patients. In approximately 2015 (reported as since 13-MAR-2015), the patients were vaccinated with doses of ROTATEQ lot # K010221, K011663, K016313 and lot # reported as K015816 (expiration dates, dose, route and site of administrations were not reported) that were exposed to temperatures outside of the recommended range. No adverse effects had been observed or reported. Follow up information has been received from the medical assistant on 02-JUL-2015 regarding the patient of an unknown age and gender who on 03-JUN-2015 was vaccinated with a dose of ROTATEQ (lot number K016313) (dose and route were not provided). There was 87 hours excursion. This lot number was received on 08-APR-2015. This is one of several reports from the same reporter. Additional information is not expected as all correspondence was received.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to an unspecified number of patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (lot number, dose and route were not provided) which was exposed to 1C for 14.2 days. No adverse effects were reported. Additional information has been requested.
Age: 1.43
Sex: M
Vaccine: HEPA
Symptoms: Angioedema, Pyrexia, Rash generalised
Clinical narrative: Information has been received from a medical assistant concerning a 18 months old male child patient. Pertinent medical history or drug reactions/allergies were unknown. In approximately September 2011, the patient was vaccinated with one and only dose of VAQTA 25/0.5 (unit unknown) (intramuscular, lot number was 670835/0628AA, expiration date 13-MAR-2014). On the same day, "within a few hours" of being administered this dose of VAQTA, the patient presented to the emergency room with a high fever, a generalized rash, and angioedema. The patient was treated with BENADRYL and steroids and was released from the emergency room that same day, a few hours after these symptoms completely resolved. The patient was never admitted to the hospital. This medical assistant noted the physician associated with this Adverse Event (AE) requested a lot check for this dose of VAQTA. The causality between VAQTA and high fever, generalized rash, and angioedema were not provided at time of reporting. Additional information has been requested. Lot number 670835/0628AA has been verified to be a valid lot number for VAQTA.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR
Symptoms: Faecal incontinence
Clinical narrative: Dx of Hirschsprung's at 1 week of age, previous bowel resection. Returned after 11/20/13 for MMR-V 5/27/14. No complaints until after cecostomy tube 5/27/15. Mom now want VAERS done for incontinent stools.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Contusion, Erythema, Injection site erythema, Injection site rash, Injection site warmth
Clinical narrative: 5.5 x 4 cm erythematous, slightly warm circular rash on (L) upper arm-lateral at site of MMRV vaccine. Bruising started on 7/2/15. Redness started on 7/6/15.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Dyspnoea, Ear congestion, Headache, Increased upper airway secretion, Lethargy
Clinical narrative: Sunday PM developed headache & body aches. Tuesday low grade fever by Thursday fever of 101. Muscle aches peeked. Friday & Saturday lethargic. Ear and throat congestion and short of breath.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Myalgia, Pain, Pyrexia
Clinical narrative: Sunday PM developed headache & body aches. Tuesday low grade fever by Thursday fever of 101. Muscle aches peeked. Friday & Saturday lethargic. Ear and throat congestion and short of breath.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Eyelid oedema, Urticaria
Clinical narrative: 12 hrs after immunizations, patient started with generalized hives, mild eye lid edema. Reaction involuted after 3 doses of BENADRYL. No resp. distress. No other antigen identified.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Blister, Dry skin, Pruritus, Rash erythematous, Varicella virus test positive
Clinical narrative: 4 y old f with hx itchy and erythematous rash on her left leg (posterior area) that follows a dermatoma. The rash started approximately 9 days after she received her 4y old immunizations. The cluster of small dry vesicles extends from the lumbar area all the way to her ankle.
Age: 0.38
Sex: M
Vaccine: PNC13
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse symptoms. Vaccine expired 7 days ago.
Sex: M
Vaccine: VARZOS
Symptoms: Adverse reaction
Clinical narrative: This spontaneous report as received from a pharmacist via company representative refers to a male patient of unknown age. The patient had no pertinent medical history, drug reactions or allergies. On an unknown date, the patient was vaccinated with a dose of ZOSTACAX (dose, lot number and expiry date were not reported). There was no concomitant medication provided. On an unknown date, the patient experienced unspecified reaction. The patient sought medical attention and saw a physician (name unspecified). The outcome of unspecified reaction was reported as resolved (unspecified date). The relatedness between the event above mentioned and ZOSTAVAX was not provided. This is one of two 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 as received from a healthcare professional refers to an unspecified number of patients. In approximately 2015 (reported as since 13-MAR-2015), the patients were vaccinated with doses of oral, ROTATEQ lot # K010221, K011663, K016313 and lot # reported as K015816 (expiration dates, dose, route and site of administrations were not reported) that were exposed to temperatures outside of the recommended range. No adverse effects had been observed or reported. Follow up information has been received from the reporting healthcare professional on 02-JUL-2015, who informed that a patient was vaccinated on 08-JUN-2015 with a dose of oral, ROTATEQ LOT # K016313, expiration date not reported, (administration route was not provided). According to the reporter the vaccine dose that was administered underwent a temperature exucrsion for 87 hours. This is one of several reports 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 as received from a healthcare professional refers to an unspecified number of patients. In approximately 2015 (reported as since 13-MAR-2015), the patients were vaccinated with doses of ROTATEQ lot # K010221, K011663, K016313 and lot # reported as K015816 (expiration dates, dose, route and site of administrations were not reported) that were exposed to temperatures outside of the recommended range. No adverse effects had been observed or reported. Follow up information has been received from the reporting healthcare professional on 02-JUL-2015, who informed that a patient was vaccinated on 05-JUN-2015 with a dose of ROTATEQ lot # K016313, expiration date not reported, (administration route was not provided). According to the reporter the vaccine dose that was administered underwent a temperature excursion for 87 hours. This is one of several report from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Muscular weakness
Clinical narrative: This spontaneous report as received from a consumer regarding her child of unknown age and gender. No information about medical history, concurrent conditions was reported for the patient. On an unknown date the patient was vaccinated with oral, ROTATEQ (dose strength unspecified). No concomitant therapy was reported. The reporter stated that once an unknown date the patient had been experiencing muscular weakness after receiving oral, ROTATEQ. The outcome of muscular weakness is unknown. No product quality complaint was involved. Additional information is not expected as there are no contact details of the reporter provided.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health care professional refers to a patient of unknown age and gender who on 14-APR-2015 was vaccinated with improperly stored dose of ROTATEQ lot # K011663 (dose and route were not provided) which was under 12 hours excursion. No adverse effect observed or reported. This is one of several reports 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 as received from a health care professional refers to a patient of unknown age and gender who on 10-APR-2015 was vaccinated with improperly stored doses of ROTATEQ lt # K011663 (dose and route were not provided) which were exposed to temperatures outside of the recommended range during 12 hours excursion. No adverse effects had been observed or reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 32.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a solicited report from a consumer and it refers to a 32-year-old female subject enrolled in a study. The subject's concurrent conditions, medical history and concomitant therapies were not reported. On 17-APR-2015, the subject was vaccinated with PNEUMOVAX (dose, frequency and indication were unknown). On an unknown date, the subject received HUMIRA (dose, frequency unknown) for rheumatoid arthritis. On 16-APR-2015, the subject experienced cold symptoms. On 17-APR-2015, the subject experienced injection site induration, injection site warmth and injection site redness. The subject had localized the reaction to PNEUMOVAX given on 17-APR-2015, indurated, six into four centimeter red in color and hot to touch. The subject did not have the lot number information because the subject was at work. The outcomes of cold symptoms, injection site induration, injection site warmth and injection site redness were unknown. The action taken with PNEUMOVAX and HUMIRA was reported as unknown. The causality between the events and PNEUMOVAX was not reported. The reporter stated that there was no reasonable possibility that the events of injection site induration, injection site warmth and injection site redness were related to HUMIRA. The reporter's statement of causality for the event of cold symptoms was not provided. No further information is expected.
Age: 32.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site erythema, Injection site induration, Injection site warmth, Nasopharyngitis
Clinical narrative: Information has been received from a solicited report from a consumer and it refers to a 32-year-old female subject enrolled in a study. The subject's concurrent conditions, medical history and concomitant therapies were not reported. On 17-APR-2015, the subject was vaccinated with PNEUMOVAX (dose, frequency and indication were unknown). On an unknown date, the subject received HUMIRA (dose, frequency unknown) for rheumatoid arthritis. On 16-APR-2015, the subject experienced cold symptoms. On 17-APR-2015, the subject experienced injection site induration, injection site warmth and injection site redness. The subject had localized the reaction to PNEUMOVAX given on 17-APR-2015, indurated, six into four centimeter red in color and hot to touch. The subject did not have the lot number information because the subject was at work. The outcomes of cold symptoms, injection site induration, injection site warmth and injection site redness were unknown. The action taken with PNEUMOVAX and HUMIRA was reported as unknown. The causality between the events and PNEUMOVAX was not reported. The reporter stated that there was no reasonable possibility that the events of injection site induration, injection site warmth and injection site redness were related to HUMIRA. The reporter's statement of causality for the event of cold symptoms was not provided. No further information is expected.
Age: 5.0
Sex: U
Vaccine: DTAP, IPV, MMR, VARZOS, VARZOS
Symptoms: Erythema, Injection site erythema, Injection site swelling, Injection site warmth, Joint swelling
Clinical narrative: Information has been received from a physician referring to a 5 year old patient of unknown gender. Pertinent medical history and drug allergy were not reported. On 25-JUN-2015 the patient was inadvertently vaccinated with a dose of ZOSTAVAX (dose, route, lot# and expiration date were unknown) instead of VARIVAX (Merck). Concomitant drug was not reported. It was not reported whether the patient sought medical attention. At the time of reporting, no adverse effects were reported. Additional information has been requested.
Age: 5.0
Sex: U
Vaccine: DTAP, IPV, MMR, VARZOS, VARZOS
Symptoms: Joint warmth, Pruritus, Skin lesion, Weight bearing difficulty, Wrong drug administered
Clinical narrative: Information has been received from a physician referring to a 5 year old patient of unknown gender. Pertinent medical history and drug allergy were not reported. On 25-JUN-2015 the patient was inadvertently vaccinated with a dose of ZOSTAVAX (dose, route, lot# and expiration date were unknown) instead of VARIVAX (Merck). Concomitant drug was not reported. It was not reported whether the patient sought medical attention. At the time of reporting, no adverse effects were reported. Additional information has been requested.
Age: 5.0
Sex: U
Vaccine: DTAP, IPV, MMR, VARZOS, VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a physician referring to a 5 year old patient of unknown gender. Pertinent medical history and drug allergy were not reported. On 25-JUN-2015 the patient was inadvertently vaccinated with a dose of ZOSTAVAX (dose, route, lot# and expiration date were unknown) instead of VARIVAX (Merck). Concomitant drug was not reported. It was not reported whether the patient sought medical attention. At the time of reporting, no adverse effects were reported. Additional information has been requested.
Age: 90.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Burning sensation, Erythema, Pain, Rash erythematous
Clinical narrative: This spontaneous report as received from a 90 year old female patient regarding herself. No concurrent condition or medical history reported. On 17-JUN-2015 at 11:00 A.M., the patient was vaccinated with ZOSTAVAX injection (unspecified dose and route). On the same day, the patient experienced burning and stinging in both legs after the administration of zoster vaccine live. On the same evening, her legs felt like they were on fire and were marked with red dots. The patient sought medical attention and contacted her unspecified physician and he advised her to take BENADRYL. The patient stated she was recovering and she was presently still taking BENADRYL. Causality was not reported. Additional information has been requested.
Age: 90.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Burning sensation, Pain, Rash erythematous
Clinical narrative: This spontaneous report as received from a 90 year old female patient regarding herself. No concurrent condition or medical history reported. On 17-JUN-2015 at 11:00 A.M., the patient was vaccinated with ZOSTAVAX injection (unspecified dose and route). On the same day, the patient experienced burning and stinging in both legs after the administration of zoster vaccine live. On the same evening, her legs felt like they were on fire and were marked with red dots. The patient sought medical attention and contacted her unspecified physician and he advised her to take BENADRYL. The patient stated she was recovering and she was presently still taking BENADRYL. Causality was not reported. Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Nerve injury, Pain, Pain in extremity
Clinical narrative: There appears to be nerve damage, acute pain for some months, now chronic.
Age: 11.0
Sex: F
Vaccine: HPV2
Symptoms: Balance disorder, Blindness unilateral, Dizziness, Headache, Vomiting
Clinical narrative: AS REPORTED BY THE MOTHER OF THE PATIENT THE SIGN AND SYMPTOMS PRESENTED WERE DIZZINESS, VOMITING, HEADACHE, IMBALANCE AND RIGHT EYE VISION LOSS.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: Fever and rash beginning approximately 3 weeks post vaccination and continued to occur approximately every three weeks through the 2nd week in March.  No further rash or fever since the 2nd week in March.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Blood creatine phosphokinase, Bursitis, Immediate post-injection reaction, Injection site pain, Myalgia
Clinical narrative: Immediate severe pain at injection site that then resulted in severe ongoing myalgias/subacromial bursitis.  Still symptomatic 9 months later.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: X-ray
Clinical narrative: Immediate severe pain at injection site that then resulted in severe ongoing myalgias/subacromial bursitis.  Still symptomatic 9 months later.