chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant regarding a patient of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date the patient was vaccinated with improperly stored ROTATEQ 2 ml, oral. No adverse event was reported. No concomitant medication was reported. The outcome of the event was unknown. No PQC (product quality complaint) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant regarding an unspecified number of patients of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date the patient were vaccinated with improperly stored M-M-R II lot # M002419/Expiration Date- 12-JAN-2018, lot # L009214/Expiration Date- 17-MAR-2017, lot # L026553/Expiration Date- 16-JUL-2017. No adverse event was reported. No concomitant medication was reported. The outcome of the event was unknown. No PQC (product quality complaint) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant regarding an unspecified number of patients of unknown demographics. There was information about concurrent condition and historical medication. On an unknown date the patient were vaccinated with improperly stored GARDASIL 9 lot # L020015/Expiration Date- 16-AUG-2017, lot # L044475/Expiration Date- 12-MAY-2017, lot # M013636/Expiration Date- 15-FEB-2018, lot # L043214/Expiration Date- 30-AUG-2017, lot # M018810/Expiration Date- 28-MAY-2018. No adverse event was reported. No concomitant medication was reported. The outcome of the event was unknown. No PQC was involved. This is one of several reports received from the same reporter. 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 medical assistant regarding an unspecified number of patients of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date the patient were vaccinated with improperly stored RECOMBIVAX HB lot # L010595/Expiration Date- 12-NOV-2016, lot # L048848/Expiration Date- 09-AUG-2018. No adverse event was reported. No concomitant medication was reported. The outcome of the event was unknown. No PQC (product quality complaint) was involved. 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 medical assistant concerning multiple unknown patients of unknown age and gender. On unknown dates, the patient were vaccinated with improperly stored ROTATEQ, lot#: M017514, expiry: 07-NOV-2017 and Lot#: L033694, expiry: 16-JUN-2017. There were no previous temperature excursion. Information on current excursions were as follows: Time/temperature for high excursion: 40 hours at highest 55.2 F (Fahrenheit). Time/temperature for low excursion: 456 hours at lowest 26.2 F. No adverse effects reported. No further information provided. This is one of two reports received from the same source. 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 medical assistant regarding an unspecified number of patients of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date the patient were vaccinated with improperly stored ROTATEQ lot # M019690/Expiration Date- 02-NOV-2017, lot # L035276/Expiration Date- 09-JUN-2017, lot # M025563/Expiration Date-06-NOV-2017. No adverse event was reported. No concomitant medication was reported. The outcome of the event was unknown. No PQC (product quality complaint) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant regarding an unspecified number of patients of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date the patient were vaccinated with improperly stored PROQUAD lot # L019995/Expiration Date- 02-DEC-2016, lot # M019232/Expiration Date- 17-OCT-2017, lot # L030589/Expiration Date- 10-FEB-2017. No adverse event was reported. No concomitant medication was reported. The outcome of the event was unknown. No PQC was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant regarding a patient of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date the patient was vaccinated with improperly stored GARDASIL 9, 0.5 ml, intramuscular. No adverse event was reported. No concomitant medication was reported. The outcome of the event was unknown. No PQC was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant regarding an unspecified number of patients of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date the patient were vaccinated with improperly stored PNEUMOVAX 23 lot # L019835/Expiration Date- 23-MAR-2017, lot # L049744/Expiration Date- 12-OCT-2017, lot # M020521/Expiration Date- 17-NOV-2017. No adverse event was reported. No concomitant medication was reported. The outcome of the event was unknown. No PQC (product quality complaint) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant concerning multiple unknown patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored GARDASIL 9 lot # L037554, expiry: 25-DEC-2017. There were no previous temperature excursion. The information on current excursions were as follows: Time/temperature for high excursion: 40 hours at highest 55.2 F (Fahrenheit). Time/temperature for low excursion: 456 hours at lowest 26.2 F. No adverse effects reported. No further information provided. This is one of two reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to the patients of unknown age and gender. The patients' medical histories, concurrent conditions and concomitant therapies were not reported. The doses of PEDVAXHIB were improperly stored at 1.5 Celsius degree for 29 minutes on 15-AUG-2016. Prior excursions included 10.2 Celsius degree for 6 hours 35 minutes on 21-JUN-2016 and 1.4 Celsius degree for 53 minutes on 09-AUG-2016. On unknown dates in 2016 (reported as "after 15-AUG-2016"), the patients were vaccinated with improperly stored PEDVAXHIB (dose, lot #, expiration date and route not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed vocational nurse refers to a 2 month old male patient with no relevant medical history, concurrent condition, drug history, laboratory data or concomitant medication. On 06-JUL-2016, the patient was vaccinated with a 2 ml dose of ROTATEQ lot # L029615 with expiration date on 15-MAY-2017, orally; that was exposed to a temperature excursion. The nurse reported that after receiving the improperly stored vaccine, no adverse events had been reported and that as of 25-AUG-2016 it was unknown if the patient would continue the therapy with ROTATEQ. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a office manager refers to a patient of an unknown age and gender. The patient's relevant medical history, concurrent condition and concomitant medication were not reported. On 20-SEP-2016, the patient was vaccinated with an expired dose of ZOSTAVAX lot # K012921 (expiry date: 29-NOV-2015 (dosage not reported). No adverse effects reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: VARCEL
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 patients' concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patients were vaccinated with an improperly stored doses of VARIVAX lot # M003439 with an expiration date: 19-JAN-2017; lot# L000453 with an expiration date 06-JAN-2017 (dose, frequency and route of administration 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: MMR
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 patients' concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patients were vaccinated with an improperly stored doses of M-M-R II (unknown albumin status) lot # L023386 with an expiration date: 25-JUN-2017 and lot # L041457 with an expiration date 22-OCT-2017 (dose, frequency and route of administration 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: HPV9
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 medical history, concurrent condition and concomitant therapy were not reported. On an unknown date, the patient was vaccinated with a dose of improperly stored GARDASIL 9 (lot # reported as L040054, expiration date 26-DEC-2017, dose and route not reported). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapy were not reported. On an unknown date, the patient was vaccinated with the first dose of VAQTA (dose, frequency, route of administration, lot # and expiration date were not reported). On an unknown date, a month before the recommended 6 month date, the patient was inadvertently vaccinated with a second dose of VAQTA (dose, frequency, route of administration, lot # and expiration date were not reported). No adverse effect was reported. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 71 year old female patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 31-AUG-2016, the patient was vaccinated with a dose of PNEUMOVAX 23 (lot # L035686 with an expiration date: 16-FEB-2017), intramuscularly (dose and anatomical location were not reported). On approximately 31-AUG-2016, reported as later that night, the patient started experiencing swelling at the injection site that was tender and warm to the touch. The following morning the patient came to the pharmacist and was told to use BENADRYL as treatment and contact to her doctor. None lab diagnostic studies were performed. The outcome of the events was reported as not recovered. The relatedness between swelling at the injection site that was tender and warm and PNEUMOVAX 23 was not reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 17 year old patient of unknown gender. The patient's pertinent medical history were not reported. On an unknown date, the patient was vaccinated with the first 0.5 ml dose of RECOMBIVAX HB (route of administration, lot number and expiration date were not reported). A month later, on an unknown date, the patient was vaccinated with the second 1.0 ml dose of RECOMBIVAX HB. Concomitant therapies were not reported. No adverse effect were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to the patients of unknown age and gender. The patients' medical histories, concurrent conditions and concomitant therapies were not reported. The doses of GARDASIL 9 were improperly stored at 1.5 Celsius degree for 29 minutes on 15-AUG-2016. Prior excursions included 10.2 Celsius degree for 6 hours 35 minutes on 21-JUN-2016 and 1.4 Celsius degree for 53 minutes on 09-AUG-2016. On unknown dates in 2016 (reported as "after 15-AUG-2016"), the patients were vaccinated with improperly stored GARDASIL 9 (0.5 ml, lot # M014929, expiration date 27-MAY-2017, route not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 40.0
Sex: F
Vaccine: FLUX, FLU4
Symptoms: Dizziness, Dyspnoea, Muscular weakness, Nausea, Paraesthesia
Clinical narrative: ~ 2 minutes after shot, extreme dizziness, nausea, difficulty breathing, tingly arms, weakness in legs.
Age: 40.0
Sex: F
Vaccine: FLUX, FLU4
Symptoms: Chest discomfort, Cough, Dizziness, Flushing, Paraesthesia
Clinical narrative: ~ 2 minutes after shot, extreme dizziness, nausea, difficulty breathing, tingly arms, weakness in legs.
Age: 28.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site pain
Clinical narrative: Pt felt (L) are underneath injection was very painful to touch, not reddened.
Age: 1.0
Sex: F
Vaccine: HEP, HEPA, VARCEL
Symptoms: Blister, Cough, Injection site swelling, Night sweats, Rash
Clinical narrative: Started off with a terrible cough at night. She started to get a large bump on left leg where shots were given. Returned to Dr on 9/15/16 about cough. Dr gave antibiotic for her cough. I asked if the cough would be from the shots a week ago, dr informed me no. On 9/19 her leg started to develop bumbs, almost bite like, was warm to touch.. very swollen. The night of 9/19 and 9/21 she woke up in night sweats. On 9/21 morning, a few blister bumps appeared on her side of face on cheek.  Her leg bumps were not blistery and she was scratching them. Made appointment with dr on 9/21 at 3pm. Informed that she has chickenpox and is having a reaction to her vaccine of them that was given on 9/8/16. Dr gave another medicine and advised for her not to return to daycare until bumps were gone.
Age: 1.0
Sex: F
Vaccine: HEP, HEPA, VARCEL
Symptoms: Skin warm, Varicella post vaccine
Clinical narrative: Started off with a terrible cough at night. She started to get a large bump on left leg where shots were given. Returned to Dr on 9/15/16 about cough. Dr gave antibiotic for her cough. I asked if the cough would be from the shots a week ago, dr informed me no. On 9/19 her leg started to develop bumbs, almost bite like, was warm to touch.. very swollen. The night of 9/19 and 9/21 she woke up in night sweats. On 9/21 morning, a few blister bumps appeared on her side of face on cheek.  Her leg bumps were not blistery and she was scratching them. Made appointment with dr on 9/21 at 3pm. Informed that she has chickenpox and is having a reaction to her vaccine of them that was given on 9/8/16. Dr gave another medicine and advised for her not to return to daycare until bumps were gone.
Age: 29.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Induration, Local swelling, Oedema
Clinical narrative: Localized swelling and erythema and induration, initiating hours after injection and increasing until 24 hours after injection. Erythema: 6.75 cm x 5.5 cm; Induration: 6.75 cm x 5.5 cm; Edema: 6.25 cm x 8 cm.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Rash, Rash papular, Rash vesicular
Clinical narrative: Both legs got rash.  Collection of erythematous papules and vesicles over lateral and anterior thighs.  Appear to be 1-2 mm.
Age: 1.25
Sex: M
Vaccine: DTAP, FLU4, MMR, VARCEL
Symptoms: Blood test normal, Crying, Diarrhoea, Irritability, Laboratory test normal
Clinical narrative: 9/19 received shots, that day fussy. Overnight vomiting x 2.  Fever.   9/20 started having increasing pain doubled over with extreme crying for 30+ minutes.  Seen in ER.  Developed petechiae in ER.  Abd u/s negative.  Sepsis work up done including LP, urine, blood , negative.  Resp pathogen panel negative.  Hospitalized 9/20-9/22.  Over course of hospital, vomiting x 5, loose stools, fever.  Another abdominal u/s negative.
Age: 1.25
Sex: M
Vaccine: DTAP, FLU4, MMR, VARCEL
Symptoms: Lumbar puncture normal, Pain, Petechiae, Pyrexia, Ultrasound abdomen normal
Clinical narrative: 9/19 received shots, that day fussy. Overnight vomiting x 2.  Fever.   9/20 started having increasing pain doubled over with extreme crying for 30+ minutes.  Seen in ER.  Developed petechiae in ER.  Abd u/s negative.  Sepsis work up done including LP, urine, blood , negative.  Resp pathogen panel negative.  Hospitalized 9/20-9/22.  Over course of hospital, vomiting x 5, loose stools, fever.  Another abdominal u/s negative.
Age: 1.25
Sex: M
Vaccine: DTAP, FLU4, MMR, VARCEL
Symptoms: Urine analysis normal, Vomiting
Clinical narrative: 9/19 received shots, that day fussy. Overnight vomiting x 2.  Fever.   9/20 started having increasing pain doubled over with extreme crying for 30+ minutes.  Seen in ER.  Developed petechiae in ER.  Abd u/s negative.  Sepsis work up done including LP, urine, blood , negative.  Resp pathogen panel negative.  Hospitalized 9/20-9/22.  Over course of hospital, vomiting x 5, loose stools, fever.  Another abdominal u/s negative.
Age: 22.0
Sex: F
Vaccine: VARCEL
Symptoms: Induration, Injection site erythema, Injection site oedema, Pain in extremity, Peripheral swelling
Clinical narrative: Client reported edema & erythema at injection site which started a couple hours after vaccine injection and got worse over time.  Client used topical bacitracin on area with no relief.  Client reported reaction to PHN on 9/21/16 @ 11:20 AM.  Area on Right arm swollen and painful to touch.  Client reports itching around area and painful when she moves her arm. Induration measured at 3 inches with erythema.  Client advised to go to Urgent care immediately.  Client agreed.
Age: 27.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Contusion, Pain, Pyrexia, Rash
Clinical narrative: Rash, bruise, fever, rigors, body aches.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: Red rash around injection site.
Age: 70.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site pain, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Injection site swollen and warm but normal color and sore. Patient said that she ran a fever overnight.
Age: 45.0
Sex: M
Vaccine: TD
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: PAIN WITH ROM - RIGHT DELTOID.
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Blood glucose normal, Dizziness, Eye movement disorder, Muscle twitching, Pallor
Clinical narrative: She felt dizzy after vaccination. BP cuff placed on her to obtain BP and she then had hand twitching and eyes went up. Lasted a few seconds. BP checked x 2 was normal. She was pale around lips. Few minutes later BP systolic dropped to 87. She then ate/drank and was monitored for 30 minutes or more and returned to normal. BP prior to leaving was normal.
Age: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: 1 hour post injection patient experienced burning sensation and pain in the right arm down to elbow.
Age: 1.0
Sex: F
Vaccine: MEN
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Patient was given a MENVEO but her minimum age did not qualify her to have this vaccine at time of administration.
Age: 45.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Arthralgia, Asthenia, Chills, Myalgia, Pyrexia
Clinical narrative: Extreme muscle and joint pain, high fever, chills, weakness.
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Loss of consciousness
Clinical narrative: Pt felt light headed and then lost consciousness.  Pharmacist caught patient and then with help, lowered patient to the floor.  Supportive care performed.  Called EMS, pt vitals within normal range.  EMS left without patient.
Age: 43.0
Sex: M
Vaccine: TDAP
Symptoms: Axillary pain, Contusion, Flank pain, Haematoma, Pain in extremity
Clinical narrative: Severe pain in Lt arm, Lt axillary, and Lt flank area.  Progressed to Lt trap.  On approximately 9/17/16 started to have bruising in above areas. Skin on Lt trapezius & upper back w/ some petichiae & diffuse hematoma.
Age: 43.0
Sex: M
Vaccine: TDAP
Symptoms: Petechiae
Clinical narrative: Severe pain in Lt arm, Lt axillary, and Lt flank area.  Progressed to Lt trap.  On approximately 9/17/16 started to have bruising in above areas. Skin on Lt trapezius & upper back w/ some petichiae & diffuse hematoma.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Urticaria
Clinical narrative: Dime sized hive on inner aspect of both forearms and 2 hives on back of neck. No SOB, dyspnea or swelling of mouth, lips or throat. Given Benadryl IM @ 10:55AM. Hives resolving. B/P & HR WNL.
Age: 66.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient reported on 9/22/16 with redness, swelling, and warm to the touch at injection site of PREVNAR (right arm). Patient is reporting to their PCP for evaluation.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Arthropathy, Crying, Hyperhidrosis, Hyperventilation, Hypoaesthesia
Clinical narrative: Upon discussing pt's due vaccines today she states she is only here for her MCV4 booster and becomes tearful. She tells me she does not like needles. Her respirations begin to increase. MCV4 vaccine quickly drawn up and given to (R) deltoid site. Ice applied before and after administration. Within a minute of administering vaccine pt begins to cry heavily, hyperventilate and perspire. She is lying down on the exam table. She then states she is feeling nauseas and feels like she needs to vomit. After a couple of minutes she states this does pass. Her complexion is pale. Pt c/o both arms going numb. She denies any pain at the injection site. Encouraged slow, deep breaths. Her wrists begin to flex and tense up. She states she is unable to move her hands or wrists. When this worker grabs her hands she is able to lightly grasp my hands. When talking she tells me her upper lip feels tingly and numb and this scares her. She begins to hyperventilate again. Encouraged slow, deep breaths. Applied ice to nape of neck. BP checked at 115/60 and P 72. When encouraged pt go to ER, she refuses. She declines to call any family members. She states she has to drive back to get to class at noon. She states she would just like to sit here until she feels better. Pt's condition gradually improves. After 55 minutes, she states she is feeling back to "normal" except for her (L) handle occasionally trembling. Encouraged pt to have family drive her. She states she will call her Grandma before she leaves and once she gets as well. She does drink about 8 oz of water, declines any crackers. Her breathing is regular and normal. Her complexion has returned to normal. She is no longer perspiring. Encouraged pt to seek emergent care should s/s return. Pt verbalizes understanding.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Hypoaesthesia oral, Mobility decreased, Nausea, Pallor, Paraesthesia oral
Clinical narrative: Upon discussing pt's due vaccines today she states she is only here for her MCV4 booster and becomes tearful. She tells me she does not like needles. Her respirations begin to increase. MCV4 vaccine quickly drawn up and given to (R) deltoid site. Ice applied before and after administration. Within a minute of administering vaccine pt begins to cry heavily, hyperventilate and perspire. She is lying down on the exam table. She then states she is feeling nauseas and feels like she needs to vomit. After a couple of minutes she states this does pass. Her complexion is pale. Pt c/o both arms going numb. She denies any pain at the injection site. Encouraged slow, deep breaths. Her wrists begin to flex and tense up. She states she is unable to move her hands or wrists. When this worker grabs her hands she is able to lightly grasp my hands. When talking she tells me her upper lip feels tingly and numb and this scares her. She begins to hyperventilate again. Encouraged slow, deep breaths. Applied ice to nape of neck. BP checked at 115/60 and P 72. When encouraged pt go to ER, she refuses. She declines to call any family members. She states she has to drive back to get to class at noon. She states she would just like to sit here until she feels better. Pt's condition gradually improves. After 55 minutes, she states she is feeling back to "normal" except for her (L) handle occasionally trembling. Encouraged pt to have family drive her. She states she will call her Grandma before she leaves and once she gets as well. She does drink about 8 oz of water, declines any crackers. Her breathing is regular and normal. Her complexion has returned to normal. She is no longer perspiring. Encouraged pt to seek emergent care should s/s return. Pt verbalizes understanding.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Tremor
Clinical narrative: Upon discussing pt's due vaccines today she states she is only here for her MCV4 booster and becomes tearful. She tells me she does not like needles. Her respirations begin to increase. MCV4 vaccine quickly drawn up and given to (R) deltoid site. Ice applied before and after administration. Within a minute of administering vaccine pt begins to cry heavily, hyperventilate and perspire. She is lying down on the exam table. She then states she is feeling nauseas and feels like she needs to vomit. After a couple of minutes she states this does pass. Her complexion is pale. Pt c/o both arms going numb. She denies any pain at the injection site. Encouraged slow, deep breaths. Her wrists begin to flex and tense up. She states she is unable to move her hands or wrists. When this worker grabs her hands she is able to lightly grasp my hands. When talking she tells me her upper lip feels tingly and numb and this scares her. She begins to hyperventilate again. Encouraged slow, deep breaths. Applied ice to nape of neck. BP checked at 115/60 and P 72. When encouraged pt go to ER, she refuses. She declines to call any family members. She states she has to drive back to get to class at noon. She states she would just like to sit here until she feels better. Pt's condition gradually improves. After 55 minutes, she states she is feeling back to "normal" except for her (L) handle occasionally trembling. Encouraged pt to have family drive her. She states she will call her Grandma before she leaves and once she gets as well. She does drink about 8 oz of water, declines any crackers. Her breathing is regular and normal. Her complexion has returned to normal. She is no longer perspiring. Encouraged pt to seek emergent care should s/s return. Pt verbalizes understanding.
Age: 85.0
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: A 4 month old was given the flu vaccine.  No harm to infant as of now, but was too young to receive the vaccine.
Age: 75.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site bruising, Injection site mass, Musculoskeletal pain, Pain in extremity
Clinical narrative: Bruise and lump at injection site.  Extremely painful upper arm.  Progressing to painful shoulder muscle.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis
Clinical narrative: Pt developed cellulitis. Went to see doctor and was started on antibiotics. If no improvement pt may need to be giving iv antibiotics.
Sex: F
Vaccine: FLUX
Symptoms: Hypersensitivity
Clinical narrative: Initial unsolicited report received from physician a via other company (Pfizer) (Manufacturer Report Number: 2016424298) on 15-SEP-2016. This case involves a female patient (age not reported) who was vaccinated with a dose of INFLUENZA VACCINE (batch number, expiry date, route and site of administration: not reported) on an unspecified date. Patient's medical history and concomitant medications were not reported. On an unspecified date, following the vaccination, patient developed allergic to flu vaccine. Laboratory investigations and corrective treatment were not reported. The outcome of the event was not reported. List of documents held by sender: none.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Rash, Swelling
Clinical narrative: Patient presented with typical rash reaction. Swelling and redness extended from the rash area. We recommended patient see doctor for possible skin/cellulitis infection. Doctor gave her antibiotic for prevention but did not think there was an infection.
Age: 14.0
Sex: F
Vaccine: HEPA, HPV9, MNQ, TDAP
Symptoms: Contusion, Erythema, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Awoke with swelling of left arm which increased over the course of a day.  Developed redness and a bruised area.  Injection site and swelling on arm distal to site very red and warm, tender to palpation.
Age: 14.0
Sex: F
Vaccine: HEPA, HPV9, MNQ, TDAP
Symptoms: Injection site warmth, Joint swelling
Clinical narrative: Awoke with swelling of left arm which increased over the course of a day.  Developed redness and a bruised area.  Injection site and swelling on arm distal to site very red and warm, tender to palpation.
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Dizziness, Hypopnoea, Swelling face
Clinical narrative: Patient called to Pharmacy and said she was dizzy, weak, and light headed.  We advised her to go to ER or Urgent care. Patient was treated for slow shallow breathing, face swelling. Patient was given a steroid shot and a prescription for prednisone.  The pharmacist  called to check on her in the late afternoon. She said she felt better.  Dr advised her not to get a flu vaccine in the future. (Patient was given FLUARIX 0.5ml, lot: 359MH, exp: 6/20/17 in left deltoid).
Age: 66.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Injection site pain
Clinical narrative: Severe pain in left shoulder where Pneumococcal Polysaccharide vaccine shot was administered.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Cyst, Mass, Ultrasound scan
Clinical narrative: Probable cellulitis following vaccine. Persistent cyst/lump 2 months after event (ie drainage planned).
Sex: U
Vaccine: FLUX, TTOX
Symptoms: Peripheral swelling
Clinical narrative: Case number PHEH2016US017542 is an initial spontaneous report received from a health care professional on 06 Jul 2016. This report refers to an unknown demographics patient. Past medical history and concomitant medications were not reported. The patient received seasonal influenza vaccine, (manufacturer: unknown, batch number: not reporter) and tetanus vaccine (manufacturer: unknown, batch number: not reported) on an unspecified date. On an unknown date, after received the tetanus and seasonal influenza vaccine (manufacturer: unknown, batch number: not reporter) on an unspecified date. On an unknown date, after receiving the tetanus and seasonal influenza vaccine patient's arm were swelled, blew up. The outcome, seriousness and causality of event were not reported.
Age: 89.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Injection site bruising, Peripheral swelling
Clinical narrative: This spontaneous report was received from a registered nurse referring to a 89 year old female patient. The patient's concurrent conditions included hypothyroidism and breast cancer in remission. On 13-SEP-2016, the patient was vaccinated with PNEUMOVAX 23 (which had the lot # reported as M027552, expiration date and dose were unknown) intramuscular route. Information regarding concomitant medication was not provided. On 13-SEP-2016 in the evening, the patient developed small bruising at the site, redness and swelling below the site, cellulitis and a 3-4" area of redness and swelling up the arm. The patient received treatment for the adverse events. At the time of reporting, the outcome of cellulitis, redness, swelling and bruising was reported as recovering. The causality assessment between the events and PNEUMOVAX 23 was not provided. Upon internal review the event cellulitis was determined to be medically significant. Additional information has been requested.
Age: 32.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Vomiting
Clinical narrative: She vomited and has been dizzy and light-headed. She called and left a message. I attempted to contact her, voice mail was left for her to call me back. Another employee in her training class did appeared to be ill (poss. stomach bug).
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Oropharyngeal pain, Rash, Rash erythematous
Clinical narrative: Patient came back to pharmacy on 9-22-16 with a rash. Also reports that her throat feels sore. Visible red rash on her neck, patient had taken one dose of benadryl. Recommended she start taking claritin and keep an eye on it to report back if not getting better.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Injection site became red, hot to touch, swollen, and very itchy. Patient was given Benadryl 25mg tab 1 PO.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Herpes zoster, Paraesthesia, Rash
Clinical narrative: Tingling on left side  -  then 2 days later shingles rash appeared.
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Chest pain, Injected limb mobility decreased, Mobility decreased, Myalgia, Pain in extremity
Clinical narrative: Severe muscle ache, chest pain, could not put arms above head, arm pain. Mom gave 800mg ibuprofen and fluids. This was injection #2 and same reaction happened with the first immunization.
Age: 70.0
Sex: F
Vaccine: FLU3, PNC, TDAP, VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient had redness and swelling at the injection site only. no other symptoms.
Sex: F
Vaccine: MENB
Symptoms: Back pain, Erythema, Inflammation
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of back pain (with radiation) in a 19-year-old female patient who received BEXSERO (batch number 151401A, expiry date unknown). On an unknown date, the patient received the 2nd dose of BEXSERO 1 ml. On an unknown date, an unknown time after receiving BEXSERO, the patient experienced back pain (with radiation) (serious criteria other: as per reporter), inflammatory reaction (serious criteria other: as per reporter) and erythema (serious criteria other: as per reporter). On an unknown date, the outcome of the back pain (with radiation), inflammatory reaction and erythema were recovered/resolved. It was unknown if the reporter considered the back pain (with radiation), inflammatory reaction and erythema to be related to BEXSERO. Additional details were reported as follows: The age at vaccination was not reported. The medical representative did not have vaccination date or expiration date of vaccine. The health care professional reported that the patient experienced severe pain that radiated to the patient's back. The patient required an urgent care visit. The urgent care deemed it as inflammation process reaction. The patient had a follow up visit to the MD and the pain and redness resolved.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Burning sensation, Erythema, Injection site pain, Pruritus, Rash
Clinical narrative: This is a spontaneous report from a contactable physician. A 66-year-old female patient received at pharmacy PREVNAR 13 (Lot Number M79320, Expiry date 31Aug2017, NDC number 0005-1971-02), intramuscular in the left deltoid at 0.5 ml, single on 28Jul2016 for immunisation.  The patient medical history includes Macular degeneration, Impaired fasting glucose, Allergic rhinitis, Raynaud's syndrome. Concomitant medications includes Age-Related Eye Disease (AREDS) vitamins for eye disorder, Vitamin D for Vitamin D deficiency. On 30Jul2016, the patient experienced burning and itching in area of anterior upper arm (bicep area) but not at the injection site, circular raised rash, redness, all with outcome of not recovered. The patient also developed pain at the injection site on an unspecified date with outcome of recovered. Reporter described the redness and rash as located on the patient's left anterior/lateral bicep, but not at the same location of the injection site. The rash was raised, burning, itching, and circular. The patient has no systemic symptoms, it was only a local reaction. The events required an emergency room or physician visit and received unspecified treatment. Follow up (07Sep2016): New information from a contactable Physician included: vaccine route of administration, exp date, medical history, concomitant medications. Follow-up attempts completed. No further information expected.
Age: 43.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site discomfort, Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Right deltoid injection site with approximately 2"x2.5" diameter red raised area. Warm & firm on palpitation with mild discomfort.
Age: 65.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Arthralgia, Chills, Fatigue, Headache, Hyperhidrosis
Clinical narrative: Unable to sleep on 9/16.  Malaise, myalgias, arthralgias, severe headache, escalating fever to 103.7 with shivering, rigor, diffuse sweating by 5 PM 9/17.  Persistent symptoms and fever to 101-102 on 9/18.  Fever 101 on 9/19.  No fever 9/20-9/21 but fatgue, malaise.
Age: 65.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Insomnia, Malaise, Myalgia, Pyrexia
Clinical narrative: Unable to sleep on 9/16.  Malaise, myalgias, arthralgias, severe headache, escalating fever to 103.7 with shivering, rigor, diffuse sweating by 5 PM 9/17.  Persistent symptoms and fever to 101-102 on 9/18.  Fever 101 on 9/19.  No fever 9/20-9/21 but fatgue, malaise.
Age: 1.75
Sex: M
Vaccine: HEPA
Symptoms: Diarrhoea
Clinical narrative: Mom reports child has had diarrhea since receiving vaccination. Reports giving child Immodium but diarrhea returns. Mom states will take child to physician on 9/23/16 for diarrhea.
Age: 28.0
Sex: M
Vaccine: FLUC4
Symptoms: Eye movement disorder, Facial paralysis, Facial paresis
Clinical narrative: Difficulty blinking one eye, which progressed to unilateral facial weakness.  Symptoms consistent with Bell's Palsy.
Age: 23.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Abortion spontaneous, Exposure during pregnancy
Clinical narrative: Employee given Varicella shot 8/22/2016.  Employee marked "yes" on pregnancy question.  I did not look at question.  Employee had a miscarriage the week of 9/12/2016.  Stated on 9/22/2016 that she was 4 weeks pregnant when given shot.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Rash macular, Urticaria
Clinical narrative: Red blotches and hives on face. Was given Benadryl 5ml by mouth per Dr. orders.
Age: 69.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pt had redness, erythema, swelling and pain at and below injection site.
Age: 35.0
Sex: F
Vaccine: DTAP
Symptoms: Hypoaesthesia, Pain, Paraesthesia
Clinical narrative: Numbness and tingling in arm and hand of vaccine administration.  Numbness and pain became worse over time where I was unable to work for several months.  Gradually I am now back to work but I still have pain and numbness in the arm and hand and have not recovered full use.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis in L arm (deltoid area). Seen in Emergency Department, treated with Amoxicillin for 7 days.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: Began with itching, swelling of L arm.  By 8:00 am arm red and swollen and PAINFUL to touch from shoulder to elbow.  Next day swollen to almost wrist. Urgent care gave shot, took antihistamine and high dose NSAD for 4 days.
Age: 58.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Musculoskeletal pain
Clinical narrative: Light headedness. Dizziness. Soreness in shoulder.
Age: 24.0
Sex: M
Vaccine: FLU4
Symptoms: Dysphagia, Erythema, Flushing, Hypoaesthesia, Paraesthesia
Clinical narrative: Pt reported to the Medical Group approximately 45-60 minutes after receiving the influenza vaccine. Pt reported that his left arm "is asleep" where he received the injection. Bilateral palms of hand had mottled appearance. Redness and flushing of the skin noted on bilateral arms and neck. Patient also reported having a "scratchy" throat but attributed it to quitting smoking three weeks ago. 25mg Benadryl PO was administered at 1510. Pt denies having any chest tightness, SOB, difficulty breathing, inability to swallow own saliva, and other severe adverse reaction signs. Capillary refill <2 seconds. Vital signs stable. Pt was kept for observation until 1550. Mottling of the palms resolved. Flushing of the skin resolved as well. Pt was directed to see his primary care provider tomorrow morning to report symptoms and to also receive evaluation for the left arm numbness and tingling.
Age: 24.0
Sex: M
Vaccine: FLU4
Symptoms: Skin discolouration, Throat irritation
Clinical narrative: Pt reported to the Medical Group approximately 45-60 minutes after receiving the influenza vaccine. Pt reported that his left arm "is asleep" where he received the injection. Bilateral palms of hand had mottled appearance. Redness and flushing of the skin noted on bilateral arms and neck. Patient also reported having a "scratchy" throat but attributed it to quitting smoking three weeks ago. 25mg Benadryl PO was administered at 1510. Pt denies having any chest tightness, SOB, difficulty breathing, inability to swallow own saliva, and other severe adverse reaction signs. Capillary refill <2 seconds. Vital signs stable. Pt was kept for observation until 1550. Mottling of the palms resolved. Flushing of the skin resolved as well. Pt was directed to see his primary care provider tomorrow morning to report symptoms and to also receive evaluation for the left arm numbness and tingling.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP, VARCEL
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis at the injection site (4in by 3.5 in). Started amoxicillin-Pot Clavulanate and follow up in 4 days.
Age: 34.0
Sex: M
Vaccine: TDAP
Symptoms: Rash
Clinical narrative: Rash on both arms.
Age: 81.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Erythema, Local swelling, Pruritus, Rash erythematous, Rash maculo-papular
Clinical narrative: Localized swelling, redness, and tenderness observed by this ARNP and presence of itching reported by patient on 09/22/2016. Red maculopapular rash described by patient in preceding days.
Age: 81.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Tenderness
Clinical narrative: Localized swelling, redness, and tenderness observed by this ARNP and presence of itching reported by patient on 09/22/2016. Red maculopapular rash described by patient in preceding days.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Injection site erythema, Injection site pain, Injection site swelling, Musculoskeletal chest pain
Clinical narrative: "SITE OF INJECTION SKIN BECAME RED, PUFFY, PAINFUL, HEART RACING, WEAKNESS AND LEFT RIB CAGE PAIN, LASTED TWO HOURS, NEXT DAY SKIN WAS STILL RED AND PUFFY, SLIGHT TENDERNESS"  TIME IS APPROXIMATION.  PATIENT REPORTED INCIDENT 9/22/16 AT 11:30, REPORTS SITE OF INJECTION IS STILL SLIGHTLY RED, NO "PUFFINESS" NO PAIN.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Palpitations
Clinical narrative: "SITE OF INJECTION SKIN BECAME RED, PUFFY, PAINFUL, HEART RACING, WEAKNESS AND LEFT RIB CAGE PAIN, LASTED TWO HOURS, NEXT DAY SKIN WAS STILL RED AND PUFFY, SLIGHT TENDERNESS"  TIME IS APPROXIMATION.  PATIENT REPORTED INCIDENT 9/22/16 AT 11:30, REPORTS SITE OF INJECTION IS STILL SLIGHTLY RED, NO "PUFFINESS" NO PAIN.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Diarrhoea, Headache, Pain, Paranasal sinus discomfort
Clinical narrative: Achiness; sinus pressure; headache; diarrhea; chills; fever.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Achiness; sinus pressure; headache; diarrhea; chills; fever.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Feeling hot, Induration, Pain
Clinical narrative: Warmth, redness, induration beginning to develop, complains of moderate pain with movement.
Age: 14.0
Sex: M
Vaccine: FLU4, HEP, HEPA, HPV9, IPV, MMR, MNQ, TDAP, VARCEL
Symptoms: Erythema, Immediate post-injection reaction, Pruritus, Rash, Throat tightness
Clinical narrative: Vaccines given at 1230. Med Asst reported that left arm became red immediately after IPV administration. At 1250, patient c/o rash, itching, throat felt tight. Administered benadryl and epipen at 1306 and transported to ER via ambulance.
Age: 18.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness
Clinical narrative: Dizzy, felt faint.
Age: 17.0
Sex: F
Vaccine: HPV9, MMR, VARCEL
Symptoms: Exposure during pregnancy, Human chorionic gonadotropin positive
Clinical narrative: Unknown
Age: 70.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Vaccination site induration, Vaccination site inflammation, Vaccination site nodule
Clinical narrative: Patient has a large golf ball sized red inflammation where the vaccine was administered, there is a small hard nodule about the size of a quarter.
Age: 70.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Incorrect product storage, Injection site erythema, Injection site swelling
Clinical narrative: Patient has a large golf ball sized red inflammation where the vaccine was administered, there is a small hard nodule about the size of a quarter.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Pain in extremity, Peripheral swelling, Pruritus, Rash macular, Skin warm
Clinical narrative: Patient stated that after receiving the vaccine her arm felt hot, sore and became swollen.  Then she developed red splotches that were itchy.  This lasted about 72-96 hrs. and slowly resolved.