chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Rheumatoid factor, Urine analysis, White blood cell count increased
Clinical narrative: This is the 1st time I ever had a flu shot, Dr. advised after husband had heart by-pass surgery and had us take vaccine. After a few days my right hand thumb pain to bottom joint - would lose grip without warning, items would fall out of hand. Also soreness on back of head with headache running on sides of head to front caused some nausea. After a few more days, noticed pain on bottom on right leg when going up my stairs, calf to knee. Leg would fall, had to hold on to stair rails to stabilze leg otherwise leg would just fall out from under me. Set appoint on December 7th with NP in Dr.'s office. Said could be nerves, gave me prescription Naprosyn and would follow up on 12/21/2017. Took Tests, Blood, Urine.  After taking 2 pills, pain mostly gone, went up stairs without holding rails, leg went out from under me.  Then pain started in my left thumb but not as bad as the right and had grip, and pain in bottom back, spine, then left leg from upper thigh to joint and left side top of arm. On 12/21/2017 NP told me that white cell counts elevated but not alarming. Told me I shouldn't take Flu shots, but did not think it was adversly due to flu shot. Schedule in 6 months. Did not think it was Guillian-Barre Syndrome because the patients she saw with that was hospitalized and very bad.  I had asked her about Guillian-Barre Syndrome because the pharmacist I spoke with stated I should be tested for this, and could have only mild symptons and would eventually go away. The pain in my left leg has gone, and only mild soreness on thumbs, very little back pain, but top right  thigh and joint, plus right top joint on arm pain and now some chest and top back tightness/soreness. Hopefully will go away.
Age: 43.0
Sex: M
Vaccine: TD
Symptoms: Abdominal pain, Asthenia, Extra dose administered, Hyperhidrosis, Pyrexia
Clinical narrative: On 01/11/2018, following a successful plasmapheresis procedure, the donor was given a dose of 0.5 mL of Mass Biologics Td toxoids adsorbed in the right arm. The donor had already been immunized on 01/07/2018 by a different Center Medical Specialist. Upon initial donor callback, the donor reported no ill effect. However, on 01/12/2018 the donor telephoned the center and left a message for the Center Medical Specialist. Upon reporting to duty at 11:00 a.m. the donor was called back. He reported fever, seating, rash, weakness, and intense abdominal cramping since approximately 7:00 p.m. the prior evening. The donor was counseled to urgently seek medical care.
Age: 43.0
Sex: M
Vaccine: TD
Symptoms: Rash
Clinical narrative: On 01/11/2018, following a successful plasmapheresis procedure, the donor was given a dose of 0.5 mL of Mass Biologics Td toxoids adsorbed in the right arm. The donor had already been immunized on 01/07/2018 by a different Center Medical Specialist. Upon initial donor callback, the donor reported no ill effect. However, on 01/12/2018 the donor telephoned the center and left a message for the Center Medical Specialist. Upon reporting to duty at 11:00 a.m. the donor was called back. He reported fever, seating, rash, weakness, and intense abdominal cramping since approximately 7:00 p.m. the prior evening. The donor was counseled to urgently seek medical care.
Age: 37.0
Sex: F
Vaccine: FLUC4
Symptoms: Discomfort, Injection site pain, Pain in extremity
Clinical narrative: Pt said shot hurt when I gave it. She had normal discomfort first night but the arm pain has not gone away. And is now radianting down her left arm heat made it worse but has done no other palitive care.
Age: 4.0
Sex: M
Vaccine: DTAP, FLU4, MMR
Symptoms: Injection site erythema, Injection site reaction
Clinical narrative: Immediate thumb print above injection sight, increasing redness over first 24 hours 6x7cm.
Age: 27.0
Sex: M
Vaccine: FLU3, HPV9
Symptoms: Asthenia, Blood pressure increased, Chest pain, Dysacusis, Feeling abnormal
Clinical narrative: Pt. was initially given flu vaccine which he tolerated well. He was then given GARDASIL 1 dose, within 3-5 min of the shot, pt complained of "feeling weird" and weak. Later complained of throat and chest and burning. This progressed to numbness spreading from head to toe. He also described hearing echoes of his voice. This was followed by twitching of R arm and foot. Pt denied SOB, chest pain, wheezing. Pt was a little sluggish but remained oriented x 4. BP increased to 150s/90s. SpO2 98% on RA, other VS stable. Pt was taken to Hosp by EMT team (911 was called after pt started twitching). Attempt was made to contact pt but unsuccessful.
Age: 27.0
Sex: M
Vaccine: FLU3, HPV9
Symptoms: Hypoaesthesia, Muscle twitching, Sluggishness, Throat irritation
Clinical narrative: Pt. was initially given flu vaccine which he tolerated well. He was then given GARDASIL 1 dose, within 3-5 min of the shot, pt complained of "feeling weird" and weak. Later complained of throat and chest and burning. This progressed to numbness spreading from head to toe. He also described hearing echoes of his voice. This was followed by twitching of R arm and foot. Pt denied SOB, chest pain, wheezing. Pt was a little sluggish but remained oriented x 4. BP increased to 150s/90s. SpO2 98% on RA, other VS stable. Pt was taken to Hosp by EMT team (911 was called after pt started twitching). Attempt was made to contact pt but unsuccessful.
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Expired product administered, Immunisation, No adverse event
Clinical narrative: This non-serious initial spontaneous case was received from other health professional on 04-Oct-2017, concerning a 26-year-old, adult, female patient. The patient's medical history and concomitant medications were not reported. On 04-Oct-2017, the patient was administered expired vaccine that expired in April of this year FLUVIRIN Thiomersal (dose: 0.5 ml, batch number: 1618621, expiry date: Apr-2017, route of administration: intramuscular, anatomical location: deltoid) (explicitly coded to expired vaccine used). No adverse effect was noted. It was reported that the patient had revaccination with the current season. The reporter assessed the report as non-serious. Significant case correction received with IRD 04-Oct-2017: The event coding was changed from no adverse event to no adverse effect. The narrative was amended accordingly. Follow-up report received on 08-Nov-2017: The age and gender of the patient was added. The anatomical location and route of administration were added. The narrative was amended accordingly.
Sex: U
Vaccine: FLU4
Symptoms: Cough, Headache, Pyrexia, Vomiting
Clinical narrative: Fever, vomiting, headache, cough, husband wasn't to take pt to ER if possible.
Age: 82.0
Sex: M
Vaccine: FLUA3, FLUA3
Symptoms: Injection site mass, Joint range of motion decreased, Pain, Pain in extremity
Clinical narrative: 1/11/18 Patient came in said arm is still sore and has a lump at injection site. Also is painful when he lifts his arm-affecting range of motion.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered medical assistant and refers to a patient of unknown age and gender. Concurrent conditions, medical history and historical drugs were not reported. On an unknown date, the patient was vaccinated with a dose of PROQUAD injection, lot # N009775, expiration date 20-SEP-2018, for prophylaxis (strength, dose, route and anatomical location not reported), which was inappropriately stored. The reporter stated that the vaccine had been under temperatures from -14 °C to -10 °C for 360 hours, without a previous temperature excursion. The sterile diluent (MERCK STERILE DILUENT) used for reconstitution of the dose of PROQUAD was properly stored. No adverse effects reported. This call was made because of a digital data logger. This is one of several reports coming from the same source.; Sender's Comments: US-009507513-1712USA014470: US-009507513-1712USA014472: US-009507513-1712USA014469: US-009507513-1712USA014468: US-009507513-1712USA014471:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered medical assistant and refers to a patient of unknown age and gender. Concurrent conditions, medical history and historical drugs were not reported. On an unknown date, the patient was vaccinated with a dose of PROQUAD injection, lot # N008826, expiration date 12-SEP-2018, for prophylaxis (strength, dose, route and anatomical location not reported), which was inappropriately stored. The reporter stated that the vaccine had been under temperatures from -14 °C to -10 °C for 360 hours, without a previous temperature excursion. The sterile diluent (MERCK STERILE DILUENT) used for reconstitution of the dose of PROQUAD was properly stored. No adverse effects reported. This call was made because of a digital data logger. This is one of several reports coming from the same source.; Sender's Comments: US-009507513-1712USA014470: US-009507513-1712USA014471: US-009507513-1712USA014472: US-009507513-1712USA013124: US-009507513-1712USA014469:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered medical assistant and refers to a patient of unknown age and gender. Concurrent conditions, medical history and historical drugs were not reported. On an unknown date, the patient was vaccinated with a dose of VARIVAX injection, lot # N012131, expiration date 17-APR-2019 (strength, dose, route and anatomical location not reported), which was inappropriately stored. The reporter stated that the vaccine had been under temperatures from -14 °C to -10 °C for 360 hours, without a previous temperature excursion. The sterile diluent (MERCK) used for reconstitution of the dose of VARIVAX was properly stored. No adverse effects reported. This call was made because of a digital data logger. This is one of several reports coming from the same source.; Sender's Comments: US-009507513-1712USA014470: US-009507513-1712USA014471: US-009507513-1712USA014472: US-009507513-1712USA014468: US-009507513-1712USA013124.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered medical assistant and refers to a patient of unknown age and gender. Concurrent conditions, medical history and historical drugs were not reported. On an unknown date, the patient was vaccinated with a dose of PROQUAD injection, lot # N009775, expiration date 20-SEP-2018, for prophylaxis (strength, dose, route and anatomical location not reported), which was inappropriately stored. The reporter stated that the vaccine had been under temperatures from -14 °C to -10 °C for 360 hours, without a previous temperature excursion. The sterile diluent (MERCK) used for reconstitution of the dose of PROQUAD was properly stored. No adverse effects reported. This call was made because of a digital data logger. This is one of several reports coming from the same source. Sender's Comments: US-009507513-1712USA013124: US-009507513-1712USA014471: US-009507513-1712USA014472: US-009507513-1712USA014468: US-009507513-1712USA014469.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered medical assistant and refers to a patient of unknown age and gender. Concurrent conditions, medical history and historical drugs were not reported. On an unknown date, the patient was vaccinated with a dose of PROQUAD injection, lot # N009775, expiration date 20-SEP-2018, for prophylaxis (strength, dose, route and anatomical location not reported), which was inappropriately stored. The reporter stated that the vaccine had been under temperatures from -14 °C to -10 °C for 360 hours, without a previous temperature excursion. The sterile diluent (MERCK) used for reconstitution of the dose of PROQUAD was properly stored. No adverse effects reported. This call was made because of a digital data logger. This is one of several reports coming from the same source. Sender's Comments: US-009507513-1712USA014470: US-009507513-1712USA013124: US-009507513-1712USA014472: US-009507513-1712USA014468: US-009507513-1712USA014469.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered medical assistant and refers to a patient of unknown age and gender. Concurrent conditions, medical history and historical drugs were not reported. On an unknown date, the patient was vaccinated with a dose of PROQUAD injection, lot # N009775, expiration date 20-SEP-2018, for prophylaxis (strength, dose, route and anatomical location not reported), which was inappropriately stored. The reporter stated that the vaccine had been under temperatures from -14 °C to -10 °C for 360 hours, without a previous temperature excursion. The sterile diluent (MERCK) used for reconstitution of the dose of PROQUAD was properly stored. No adverse effects reported. This call was made because of a digital data logger. This is one of several reports coming from the same source. Sender's Comments: US-009507513-1712USA014470: US-009507513-1712USA014471: US-009507513-1712USA013124: US-009507513-1712USA014468: US-009507513-1712USA014469.
Age: 14.0
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a consumer via Clinic refers to a currently 14 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 18-AUG-2017, the patient was vaccinated with improperly stored dose of M-M-R II, recombinant human albumin (rHA) 1 dose unit (lot # M020073, Expiry date was not reported)) for prophylaxis (product storage error). There were no previous temperature excursions recorded. It was unknown if data logger was involved. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1801USA000166:
Age: 4.0
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a consumer via Clinic refers to a currently 4 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 20-APR-2017, the patient was vaccinated with improperly stored dose of M-M-R II, recombinant human albumin (rHA) 1 dose unit (lot # M008589, Expiry date was not reported) for prophylaxis (product storage error). There were no previous temperature excursions recorded. It was unknown if data logger was involved. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1801USA000166:
Age: 1.0
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a consumer via Clinic refers to a currently 21 month old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 16-MAR-2017, the patient was vaccinated with improperly stored dose of M-M-R II, recombinant human albumin (rHA) 1 dose unit (lot # M008589, Expiry date was not reported) for prophylaxis and subsequently on 11-OCT-2017, the patient was vaccinated with improperly stored dose of M-M-R II, 1 dose unit ( lot # M044350, Expiry date was not reported) and LIQUID PEDVAXHIB 1 dose unit (Lot # M025193, Expiry date : 21-MAR-2019) for prophylaxis (product storage error). There were no previous temperature excursions recorded. It was unknown if data logger was involved. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1801USA000166.
Age: 5.0
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a consumer via Clinic refers to a currently 6 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 07-AUG-2017, the patient was vaccinated with improperly stored dose of M-M-R II, recombinant human albumin (rHA) 1 dose unit (lot # M020073, Expiry date was not reported) for prophylaxis (product storage error). There were no previous temperature excursions recorded. It was unknown if data logger was involved. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1801USA000166.
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper, Complication associated with device, Electroencephalogram abnormal, Epilepsy, Intellectual disability
Clinical narrative: This spontaneous report was received from a consumer (patient's mother) and refers to a currently 18-year-old, non-pregnant female patient. The patient's concurrent conditions was not reported. The patient did not have drug reactions or allergies. On an unknown day, reported as "sometime in either 2011 or 2012", the patient was vaccinated with GARDASIL, 1 dose, intramuscularly, for prevention of HPV (lot# and expiration date were not reported). Concomitant therapies included TEGRETOL. On an unknown date, reported as "approximately one to two weeks after receiving the vaccine", the patient experienced seizure. On an unknown date, reported as "after began to have seizures", the patient was diagnosed with epilepsy. The patient's mother reported that her daughter at the day of the reporting was 18 years old and since she had received the GARDASIL and had experienced the seizures, her daughter was mentality of a 6 to 10 year old. The reporter reported that the GARDASIL caused her to become mentally retarded. On an unknown dates the patient was hospitalized due to epilepsy. On 05-JAN-2018, the patient experienced seizures which caused stomach pain, sore muscles and knocked her braces out of her mouth. On an unknown date, the patient had performed developmental testing which confirmed that the patient was mentally retarded. On an unknown date in December 2017, reported as "approximately two weeks ago", the patient had an electroencephalography (EEG) which showed that patient had active seizures. The outcome of the events was reported as not recovered. The relatedness between the seizure, mentally retarded and GARDASIL was reported as related.
Sex: F
Vaccine: HPV4
Symptoms: Mouth injury, Myalgia, Neurodevelopment test, Seizure
Clinical narrative: This spontaneous report was received from a consumer (patient's mother) and refers to a currently 18-year-old, non-pregnant female patient. The patient's concurrent conditions was not reported. The patient did not have drug reactions or allergies. On an unknown day, reported as "sometime in either 2011 or 2012", the patient was vaccinated with GARDASIL, 1 dose, intramuscularly, for prevention of HPV (lot# and expiration date were not reported). Concomitant therapies included TEGRETOL. On an unknown date, reported as "approximately one to two weeks after receiving the vaccine", the patient experienced seizure. On an unknown date, reported as "after began to have seizures", the patient was diagnosed with epilepsy. The patient's mother reported that her daughter at the day of the reporting was 18 years old and since she had received the GARDASIL and had experienced the seizures, her daughter was mentality of a 6 to 10 year old. The reporter reported that the GARDASIL caused her to become mentally retarded. On an unknown dates the patient was hospitalized due to epilepsy. On 05-JAN-2018, the patient experienced seizures which caused stomach pain, sore muscles and knocked her braces out of her mouth. On an unknown date, the patient had performed developmental testing which confirmed that the patient was mentally retarded. On an unknown date in December 2017, reported as "approximately two weeks ago", the patient had an electroencephalography (EEG) which showed that patient had active seizures. The outcome of the events was reported as not recovered. The relatedness between the seizure, mentally retarded and GARDASIL was reported as related.
Sex: F
Vaccine: PNC13
Symptoms: Allergy to vaccine, Drug hypersensitivity
Clinical narrative: This is a spontaneous report from Pfizer sponsored program, by a contactable physician. A 71-year-old female patient of an unspecified race/ethnicity received PREVNAR 13, via an unspecified route of administration at single dose on an unspecified for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced allergies: Statins; PREVNAR 13 on an unspecified date with outcome of unknown.
Age: 13.0
Sex: F
Vaccine: FLU4
Symptoms: Influenza
Clinical narrative: This case was reported by a consumer via sales rep and described the occurrence of influenza in a 13-year-old female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent). On an unknown date, the patient received Influenza vaccine Quadrivalent at an unknown dose. In December 2017, less than a month after receiving Influenza vaccine Quadrivalent, the patient experienced influenza. In December 2017, the outcome of the influenza was recovered/resolved. It was unknown if the reporter considered the influenza to be related to Influenza vaccine Quadrivalent. Additional details were provided as follows: The age at vaccination was not reported. The patient received an unknown flu vaccine within the last 2 weeks before the date of reporting and caught the flu afterwards. The patient was fine and had recovered.
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Hypersensitivity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of allergic reaction in a 39-year-old female patient who received FLUARIX Quadrivalent. Concurrent medical conditions included food allergy (Allergic to mammal products, including pork, beef, gelatin, and dairy). On 10th November 2017, the patient received FLUARIX Quadrivalent (intramuscular). On an unknown date, less than a year after receiving FLUARIX Quadrivalent, the patient experienced allergic reaction. On an unknown date, the outcome of the allergic reaction was unknown. The reporter considered the allergic reaction to be possibly related to FLUARIX Quadrivalent. Additional details were provided as follows: The patient received FLUARIX Quadrivalent in right deltoid. The patient had seen an increase in the number of reactions to these products since received the vaccine. The reporter gave permission for the patient's physician to be contacted but did not have their name or telephone number at the time of the call and the reporter was not able to provide the lot number or expiration date for the vaccination.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Hypoaesthesia, Mobility decreased, Musculoskeletal pain, Pain, Pain in extremity
Clinical narrative: Pt received TDaP vaccine on 12/14/17 11:36 after screening questions indicate she had not had previous adverse reaction to this vaccine and no hx of allergy to the vaccine. Pt notifies clinic via phone call on 12/15/17 at 1536 that she was experiencing pain site of vaccine since am. States she is unable to move right arm. Offered patient follow-up appt with provider. Pt declines. Advised to use cold compress/NSAID to manage pain & to report if sx persist or worsen. Advised pt of Urgent Care hours available. 12/19/17 placed call to patient to f/u. Pt reports that is experiencing burning pain right shoulder which limits mobility of right arm. Pt has not scheduled follow-up on problem or gone to Urgent Care for re-evaluation of symptoms. Patient did have appointment with gynecologist 12/18/17 and communicated problem to provider. Provider gave Rx for NORCO to manage Rt shoulder pain. Pt states she has not taken this Rx. PCP notified. PCP places call to patient 12/19/17 and advises patient to come for exam in clinic, offered same day appt. Pt declines stating it is too difficult to get to clinic. 12/20/17 Pt comes to Urgent Care for exam reports Rt arm pain and numbness in fingertips right hand. Exam reveals no erythema, warmth or skin changes in deltoid area. Pt reported moderate to severe tenderness to palpation at mid humerus around biceps/triceps. No redness, warmth, at site of tenderness. Pt told passive ROM by provider but is unable to actively move her right arm. No evidence cellulitis. Advised to continue ice, NSAID, Alpha lipoic Acid Supp, Arnica cream, and sling. Advised to follow-up in one week. Pt received temporary handicap placard for 3 wks at her insistence. 12/26/17 Pt calls to report arm is not getting better. Appointment scheduled for f/u PCP 12/28/17. 12/26/17 pt calls to cancel appt and reschedules with another provider 01/05/18. On 01/03/15 Pt calls to report her right arm is still in pain with burning sensation and limited mobility. She cancels appt 01/05/18 stating she has not had labs drawn yet. She believes she has nerve damage related to Tdap administration 12/14/17. 01/11/18 Pt has appt with new provider and requesting referral to neurology. Full exam completed. Xray Rt shoulder ordered: negative exam. Rt shoulder/arm appearance normal. Exam notes state pt has limited ROM, full strength, 2+ reflexes, sensation to light touch. Gabapentin therapy ordered. Referrals initiated to physical therapy and neurology. Pt advised to continue ice/heat & ADVIL PRN.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Tenderness, Vaccination site pain, X-ray limb normal
Clinical narrative: Pt received TDaP vaccine on 12/14/17 11:36 after screening questions indicate she had not had previous adverse reaction to this vaccine and no hx of allergy to the vaccine. Pt notifies clinic via phone call on 12/15/17 at 1536 that she was experiencing pain site of vaccine since am. States she is unable to move right arm. Offered patient follow-up appt with provider. Pt declines. Advised to use cold compress/NSAID to manage pain & to report if sx persist or worsen. Advised pt of Urgent Care hours available. 12/19/17 placed call to patient to f/u. Pt reports that is experiencing burning pain right shoulder which limits mobility of right arm. Pt has not scheduled follow-up on problem or gone to Urgent Care for re-evaluation of symptoms. Patient did have appointment with gynecologist 12/18/17 and communicated problem to provider. Provider gave Rx for NORCO to manage Rt shoulder pain. Pt states she has not taken this Rx. PCP notified. PCP places call to patient 12/19/17 and advises patient to come for exam in clinic, offered same day appt. Pt declines stating it is too difficult to get to clinic. 12/20/17 Pt comes to Urgent Care for exam reports Rt arm pain and numbness in fingertips right hand. Exam reveals no erythema, warmth or skin changes in deltoid area. Pt reported moderate to severe tenderness to palpation at mid humerus around biceps/triceps. No redness, warmth, at site of tenderness. Pt told passive ROM by provider but is unable to actively move her right arm. No evidence cellulitis. Advised to continue ice, NSAID, Alpha lipoic Acid Supp, Arnica cream, and sling. Advised to follow-up in one week. Pt received temporary handicap placard for 3 wks at her insistence. 12/26/17 Pt calls to report arm is not getting better. Appointment scheduled for f/u PCP 12/28/17. 12/26/17 pt calls to cancel appt and reschedules with another provider 01/05/18. On 01/03/15 Pt calls to report her right arm is still in pain with burning sensation and limited mobility. She cancels appt 01/05/18 stating she has not had labs drawn yet. She believes she has nerve damage related to Tdap administration 12/14/17. 01/11/18 Pt has appt with new provider and requesting referral to neurology. Full exam completed. Xray Rt shoulder ordered: negative exam. Rt shoulder/arm appearance normal. Exam notes state pt has limited ROM, full strength, 2+ reflexes, sensation to light touch. Gabapentin therapy ordered. Referrals initiated to physical therapy and neurology. Pt advised to continue ice/heat & ADVIL PRN.
Age: 54.0
Sex: M
Vaccine: FLUR3
Symptoms: Injection site pain
Clinical narrative: Pt reports to pain in L shoulder that is localized to injection site. This vaccination was administered at a healthfair and it is unclear of the exact name of the flu shot. He followed up with us in primary care 6 weeks after the injection to report the pain. He has no exam findings to suggest infection, nerve damage, obvious muscle damage.
Age: 49.0
Sex: F
Vaccine: FLUC4
Symptoms: Cough, Groin pain, Nervous system disorder
Clinical narrative: Within an hour of getting the vaccine, I experienced the prodromal symptom I have had prior to an anaphylactic reaction to RITUXIN and Gentamicin which is deep painful right groin pain. I have had a chronic cough since the vaccination plus a weird neurological sensation on the skin on my face as well.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site swelling, Pain in extremity
Clinical narrative: Injection site hard lump and very red and raised. Said some pain in arm as well. I told he cold compress and normal pain reliever also hydrocortisone if needed. Go to dr if gets worse or not better. She said she didnt notice anything until Thursday had injection on Tuesday.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Cellulitis, Rash, Swelling
Clinical narrative: Pt. brought to our attention that she was diagnosed w/ Cellulitis according to her MD office. Rash/ swelling, other misc. symptoms.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site warmth
Clinical narrative: Pt states she did not have a reaction on the date of the vaccine. On wednesday she notices a rash on her arm at the injection site ranging 4-5 inches long and 3 inches wide. she states it was warm to touch and slightly itching sometimes. She states it has gotten better since Wednesday but the site is still red. I told pt to try taking some benadryl to help the rash. If she continues to see the rash she needs to get checked out by a doctor.
Age: 34.0
Sex: M
Vaccine: HEP
Symptoms: Aphthous ulcer, Lymphadenopathy, Pain
Clinical narrative: Pt reported on 01-11-18 at 7:12 pm that he experienced a canker sore, lymphadenopathy, and body aches. Administration site had no redness or swelling. Pt is following up with PCP on 01-12-18 to inquire about any recommended treatment. Pharmacist on duty advised Pt to take ibuprofen or acetaminophen if needed for discomfort. Pt will contact pharmacy to discuss PCP suggestions/input.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, RV5
Symptoms: Febrile convulsion, Pyrexia
Clinical narrative: Received PENTACEL, Rotavirus 1/10/18. Fever 104 degrees F 1/11/18. Febrile seizure 1/11/18. Hospital diagnosed roseola?
Sex: F
Vaccine: HPV4
Symptoms: Colitis ulcerative, Gastrointestinal injury, Immune system disorder, Large intestinal ulcer haemorrhage, Seizure
Clinical narrative: This initial spontaneous report was received via a letter to the company from the mother (who is also a lawyer) and refers to her daughter of unspecified age. The mother stated her daughter was a previously healthy young lady and never had a gastrointestinal or autoimmune issue ever before in her life. On an unspecified date, her daughter was vaccinated with GARDASIL (lot number not provided). The mother stated she just discovered that her perfectly healthy daughter's immune system and gastrointestinal tract were injured by the GARDASIL vaccine. She stated GARDASIL was the catalyst to her daughter's ulcerative colitis - a case so severe that 2/3 of her colon was filled with bleeding ulcers. She stated "the doctor was afraid she would have to have her colon removed at the age of 22!" She also stated GARDASIL caused her daughter to have a seizure. The outcome of the events were unknown. The reporter stated that prior to filing a lawsuit, she was contacting the company to give the chance to seriously discuss a pre-suit settlement. Upon internal review, ulcerative colitis, 2/3 of her colon was filled with bleeding ulcers, and seizure were considered to be medically significant. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling, Pain, Pyrexia
Clinical narrative: 4 y/o female with H/O low grade fever and right arm swelling/erythema. Swelling and erythema extending to mid-arm. Significant pain. Symptoms began within 10 hours of receiving vaccines.
Age: 18.0
Sex: F
Vaccine: HPV9
Symptoms: Electrocardiogram normal, Partial seizures, Syncope, Urinary incontinence
Clinical narrative: Patient received HPV9 and had a fingerprick for capillary blood collection performed, within minutes of these procedures she had a syncopal episode followed by a partial seizure involving the right side that lasted approximately 2 minutes and included bladder incontinence.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Pyrexia
Clinical narrative: Febrile, developed 10 by 11cm red area at injection site.
Age: 1.0
Sex: F
Vaccine: FLU4, HEPA, MMR, PNC13
Symptoms: Immune thrombocytopenic purpura, Platelet count decreased
Clinical narrative: ITP.
Age: 22.0
Sex: F
Vaccine: PPV
Symptoms: C-reactive protein increased, Headache, Injection site cellulitis, Injection site erythema, Leukocytosis
Clinical narrative: Patient developed redness at site of injection; also developed headaches, body aches and a fever on 01/11/18. Given IV dose of antibiotic for presumed cellulitis at site of injection. Started on oral AUGMENTIN.
Age: 22.0
Sex: F
Vaccine: PPV
Symptoms: Pain, Pyrexia, White blood cell count increased
Clinical narrative: Patient developed redness at site of injection; also developed headaches, body aches and a fever on 01/11/18. Given IV dose of antibiotic for presumed cellulitis at site of injection. Started on oral AUGMENTIN.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Swelling
Clinical narrative: Continued pain at the injection site since the day after the injection so currently with 3 months of injection site pain. No skin changes noted, no neuro symptoms. Mild swelling. No signs of infection.
Age: 52.0
Sex: F
Vaccine: FLU4, PPV, FLU4, PPV
Symptoms: Rash erythematous
Clinical narrative: Patient called pharmacy on 01/12/18 reporting a rash on the arm which she sent a picture. Red rash with 5 inch margins. Patient stated that it was showing a little red starting 30 minutes after shot but did not contact us until 2 days later. We sent patient to urgent care and they prescribed ranitidine, and certerizine for reaction. Pharmacy gave her benadryl to take 50mg dose at night and will be contacting her on Monday.
Age: 52.0
Sex: F
Vaccine: FLU4, PPV, FLU4, PPV
Symptoms: Rash, Rash erythematous
Clinical narrative: Patient called pharmacy on 01/12/18 reporting a rash on the arm which she sent a picture. Red rash with 5 inch margins. Patient stated that it was showing a little red starting 30 minutes after shot but did not contact us until 2 days later. We sent patient to urgent care and they prescribed ranitidine, and certerizine for reaction. Pharmacy gave her benadryl to take 50mg dose at night and will be contacting her on Monday.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Pruritus
Clinical narrative: PATIENT PRESENTED WITH A RED MARK UNDER HER DELTOID ANGLING TOWARDS THE BICEP ABOUT 4 INCHES BY 1 INCH AND REPORTED ITCHING ASSOCIATED WITH THE REDNESS.
Age: 12.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site pruritus, Injection site swelling
Clinical narrative: Localized swelling and itching L arm at site of injection; given ZYRTEC, ibuprofen, hc cream; will continue to f/u at school clinic.
Age: 8.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site pruritus, Injection site swelling
Clinical narrative: On the afternoon following the vaccine, patient noted swelling and itching of upper arm originating at site of influenza injection. Parent gave him Benadryl, swelling continued to grow; at peak arm swollen shoulder to elbow. Parent took child to Urgent Care clinic.
Age: 1.25
Sex: F
Vaccine: DTAP, HIBV, PNC13
Symptoms: Injection site erythema, Pyrexia, Vaccination site mass, Vaccination site pain
Clinical narrative: She had a fever spike to 103 about 23 hours after administration. This lasted 48 hours, but was managed with TYLENOL and MOTRIN. She also still has a small, red, painful lump at the vaccination site on her right thigh. It has been over a week since administration.
Age: 26.0
Sex: F
Vaccine: FLU4
Symptoms: Discomfort, Injection site pain, Musculoskeletal stiffness, Pain
Clinical narrative: Severe pain at injection site for greater than 3 months causing shoulder to feel stiff, painful to move. Feeling of heaviness.
Age: 81.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Immediate post-injection reaction, Rash, Swelling
Clinical narrative: Patient experienced immediately swelling at time of injection, however the swelling resolved within a few minutes with no pain, redness or rash reported after follow up.
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Rash
Clinical narrative: Patient has been breaking out in a rash on his upper and lower extremities.
Age: 27.0
Sex: M
Vaccine: FLU4
Symptoms: Dizziness, Pallor
Clinical narrative: THE PATIENT RECEIVED THE FLU SHOT AND APPROXIMATELY 10 MINUTES AFTER RECEIVING THE VACCINE HE BEGAN TO FEEL LIGHTHEADED. THE PATIENT STATED HE FELT DIZZY AND BEGAN TO LOOK PALE. HE WAS BROUGHT A WHEELCHAIR TO SIT IN AND AN AMBULANCE WAS CALLED. WHEN THE AMBULANCE CAME AND CHECKED HIS BLOOD PRESSURE, IT WAS 80/50. OXYGEN SATURATION WAS AT 100%. HE WAS FEELING BETTER BEFORE THE AMBULANCE TOOK HIM AWAY.
Age: 22.0
Sex: F
Vaccine: TDAP
Symptoms: Mobility decreased, Pain, Pruritus, Rash erythematous, Skin warm
Clinical narrative: Large red rash, swelling to the size of a golf ball, many small welts surrounding the area, itchy, hot to the touch, severe pain- unable to move arm or carry anything for 2 days. Ibuprofen/acetaminophen and icing the injection site offer little to no relief.
Age: 22.0
Sex: F
Vaccine: TDAP
Symptoms: Swelling, Urticaria
Clinical narrative: Large red rash, swelling to the size of a golf ball, many small welts surrounding the area, itchy, hot to the touch, severe pain- unable to move arm or carry anything for 2 days. Ibuprofen/acetaminophen and icing the injection site offer little to no relief.
Age: 57.0
Sex: F
Vaccine: PNC13
Symptoms: Blood glucose increased, Fatigue, Headache, Injected limb mobility decreased, Injection site pain
Clinical narrative: Sore upper left arm...cannot lift it, headache, muscle aches, fatigue, light sensitivity, increased glucose levels...233.
Age: 57.0
Sex: F
Vaccine: PNC13
Symptoms: Myalgia, Photophobia
Clinical narrative: Sore upper left arm...cannot lift it, headache, muscle aches, fatigue, light sensitivity, increased glucose levels...233.
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Musculoskeletal pain, X-ray normal
Clinical narrative: Persistent shoulder pain post immunization-failed NSAID, TYLENOL #3. Imaging (x-ray) WNL-referred to Ortho for steroid injection.
Sex: F
Vaccine: FLU3
Symptoms: Allergy to vaccine
Clinical narrative: Case number PHHY2016US179748 is an initial spontaneous report received via Vaccine Adverse Event Reporting System (VAERS reference number: 650821) on 21 Dec 2016. This report refers to a female patient of an unknown age. Medical history and concomitant medication was not reported. The patient was vaccinated with FLUVIRIN (batch number: not reported) on an unknown date. On an unknown date, the patient experienced allergy to FLUVIRIN. The outcome, seriousness, causality of the event was not reported.
Sex: M
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effect; patient was administered with improperly stored doses of GARDASIL 9; Information has been received from a physician referring to a 15 year old male patient. Information about the patient's concurrent condition, concomitant medication and medical history was not provided. On an unknown dates, the patient was vaccinated with improperly stored (Temperature: 47 Fahrenheit to 77 Fahrenheit; Time frame: 40 minutes) doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # M043731, expiration date: 22-JUN-2019; the dose and route were not reported) for prophylaxis on an unspecified after July 2017. No adverse effect reported. It was reported that there were no previous temperature excursion and there was a data logger involved.  This is one of the multiple reports received from the same reporter.
Age: 60.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Asthenia, Erythema, Feeling abnormal, Muscular weakness, Nausea
Clinical narrative: Case number PHHY2017US030534 is an initial spontaneous report received via Vaccine Adverse Events Reporting System (VAERS reference number 660093) on 21 Feb 2017. This report refers to a 60 year old female patient. She had no medical history or current conditions. Her concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 1618701) intramuscularly and ZOSTAVAX (batch number: M026878) subcutaneously; both vaccines administered in the left arm on 29 Sep 2016. On 30 Sep 2016, the patient's arm was swollen, red, itchy painful and weak. The patient felt weak, poorly and nauseated on the same day. The patient presented to the pharmacy on 02 Oct 2016. The events outcome was reported as unknown. The events were reported as non-serious. The causality of the events was not reported.
Age: 60.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: Case number PHHY2017US030534 is an initial spontaneous report received via Vaccine Adverse Events Reporting System (VAERS reference number 660093) on 21 Feb 2017. This report refers to a 60 year old female patient. She had no medical history or current conditions. Her concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 1618701) intramuscularly and ZOSTAVAX (batch number: M026878) subcutaneously; both vaccines administered in the left arm on 29 Sep 2016. On 30 Sep 2016, the patient's arm was swollen, red, itchy painful and weak. The patient felt weak, poorly and nauseated on the same day. The patient presented to the pharmacy on 02 Oct 2016. The events outcome was reported as unknown. The events were reported as non-serious. The causality of the events was not reported.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Fatigue, Headache, Hot flush, Pain, Pain in extremity
Clinical narrative: Severe headache, body aches, fatigue, hot flashes, and arm pain lasting greater than 72 hours post vaccine. Given ibuprofen which didn?t help much.
Age: 0.25
Sex: M
Vaccine: DTAP
Symptoms: Eczema, Irritability, Listless, Pain, Pyrexia
Clinical narrative: Child developed eczema on entire body, vomited, bled rectally after consuming Dairy through breastmilk. This has never happened prior to vaccine. He developed and maintained a fever almost immediately which lasted for 48 hours. He was grumpy, listless, and in pain.
Age: 0.25
Sex: M
Vaccine: DTAP
Symptoms: Rectal haemorrhage, Vomiting
Clinical narrative: Child developed eczema on entire body, vomited, bled rectally after consuming Dairy through breastmilk. This has never happened prior to vaccine. He developed and maintained a fever almost immediately which lasted for 48 hours. He was grumpy, listless, and in pain.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site bruising
Clinical narrative: Straight line bruise vertically down arm from injection site extending down about 3 inches. Still visible now.
Age: 65.0
Sex: F
Vaccine: FLUA3, FLUA3
Symptoms: Erythema, Hyperaesthesia, Mobility decreased, Peripheral swelling
Clinical narrative: Red, swollen arm that was very sensitive to the touch and hard to move.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Feeling cold, Injection site pain, Muscle tightness, Tremor
Clinical narrative: I started having strange infrequent sharp, dull pains in my left shoulder/ upper left back area around 10:00 pm (I received the injection in my left arm). Around 12:30 my body and muscles felt very tight. Around 1:00 pm I started feeling very cold, even though the temperature in my bedroom was 73. I started shaking and shivering which lasted about 20 minutes after which time I went to sleep. I had to put two down blankets over myself and that helped me feel warmer but could not stop shivering. I had imbibed 1 1/2 glasses of wine and a rum cocktail earlier in the evening.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Syncope
Clinical narrative: After injection patient got up from chair and preceded to exit the administration area and fainted. Father at the time did have a hold of him so he did not fall. Offered to call 911 but father refused. Patient did regain conscious after a 20 seconds. Was able to respond and after a couple of minutes slowly sat him on a chair where he waited with his father until he felt well enough to walk on his own.. approx 10 to 15 minutes. During that time kept on looking in on how he was doing.
Age: 1.25
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Aphasia, Cough, Croup infectious, Crying, Dyspnoea
Clinical narrative: Fever, unconsolable crying, quit talking, sick pretty much the whole time from a few hours after receiving the vaccine, still gets sick frequent with what I believe is croup(went to the er twice within 6 months of getting it for being unable to breathe due to a barking cough), still isn't talking much.
Age: 1.25
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Malaise, Pyrexia
Clinical narrative: Fever, unconsolable crying, quit talking, sick pretty much the whole time from a few hours after receiving the vaccine, still gets sick frequent with what I believe is croup(went to the er twice within 6 months of getting it for being unable to breathe due to a barking cough), still isn't talking much.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Body temperature increased, Irritability
Clinical narrative: Patient received vaccines on 01/08/2018, then on 01/09/2018 mother of patient reports that the patient woke up with a temperature of 103.3 and was unusually fussy. Upon arriving to our pediatrics office we took the patient's temperature auxiliary and it was 102.3, so we gave 1.6 ml of Ibuprofen. No other symptoms were reported by the mother, and no other symptoms were noted/reported by the doctor.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, FLUX, RV1
Symptoms: Cough, Respiratory tract congestion, Rhinorrhoea, Sneezing
Clinical narrative: 24 hours after receiving vaccines, he presented with runny nose, congestion, cough, and sneezing.
Age: 52.0
Sex: F
Vaccine: PPV
Symptoms: Induration, Nodule
Clinical narrative: Patient had a hard knot on her arm after the administration of Pneumovax 23 vaccination. Patient was give an ice pack. Patient was suppose to stop by the pharmacy the next day .
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood test, Rash, Urticaria
Clinical narrative: A rash and hives ever since getting the vaccine if the environmental temperature is above 75 degrees Fahrenheit inside or out of doors. Cannot go outside during summer months at all.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, FLUX, HEP, PPV
Symptoms: Injection site erythema, Injection site swelling, Irritability, Pyrexia, Vomiting
Clinical narrative: The baby had a low grade fever that started in the early hours of the morning the day after the vaccine. At some point one of the four vaccine sites became swollen and red. I treated with a cold compress but saw no immediate improvement yet. I considered both of those reactions to be fairly normal. Almost 24 hours after the vaccine the baby became unusually fussy and then forcefully (not quite projectile) vomited an entire feeding. As I type he's currently sleeping after the event.
Age: 74.0
Sex: F
Vaccine: FLUC4
Symptoms: Muscle spasms, Nausea
Clinical narrative: Patient experienced intense leg cramping and nausea after receiving FLUCELVAX. The patient stated that her symptoms were those of when she consumed eggs.