chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 46.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician assistant and refers to a 46 year old patient of unknown gender. There was no information regarding the patient's medical history, concomitant medications, drug reactions and allergies provided. On 07-DEC-2017, the patient was vaccinated with PROQUAD, therapy type rHA, lot # M044575, expiration date 04-MAY-2018, for prophylaxis (dose and route of administration were not provided). Concomitant therapies included sterile diluent. The administered dose of PROQUAD was stored in the refrigerator from 18-OCT-2017, in temperature of 38 degrees Fahrenheit for 1200 hours (50 days). The call was because of digital data logger. There was no previous temperature excursion. No adverse effect was reported. This is one of a several reports received from the same reporter. Sender's Comments: US-009507513-1712USA009167.
Age: 25.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician assistant and refers to a 25 year old patient of unknown gender. There was no information regarding the patient's medical history, concomitant medications, drug reactions and allergies provided. On 07-DEC-2017, the patient was vaccinated with PROQUAD, therapy type rHA, lot # M044575, expiration date 04-MAY-2018, for prophylaxis (dose and route of administration were not provided). Concomitant therapies included sterile diluent. The administered dose of PROQUAD was stored in the refrigerator from 18-OCT-2017, in temperature of 38 degrees Fahrenheit for 1200 hours (50 days). The call was because of digital data logger. There was no previous temperature excursion. No adverse effect was reported. This is one of a several reports received from the same reporter.; Sender's Comments:  US-009507513-1712USA009167:
Sex: U
Vaccine: HPVX
Symptoms: Adverse event
Clinical narrative: This spontaneous report as received from a consumer refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On an unknown date, the patient was vaccinated with a dose of GARDASIL (dose, frequency, route of administration, lot# and expiration date were not reported) or a dose of GARDASIL 9 (dose, frequency, route of administration, lot# and expiration date were not reported). It was unknown if product was GARDASIL or GARDASIL 9. On an unknown date, the patient experienced adverse event unspecified. The outcome of adverse event was unknown. The relatedness between the adverse event and therapy with GARDASIL or GARDASIL 9 was not reported. This is one of six reports received from the same source. Sender's Comments: US-009507513-1712USA014392: US-009507513-1712USA014394: US-009507513-1712USA014395: US-009507513-1712USA014396: US-009507513-1712USA013057.
Sex: U
Vaccine: HPVX
Symptoms: Adverse event
Clinical narrative: This spontaneous report as received from a consumer refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On an unknown date, the patient was vaccinated with a dose of GARDASIL (dose, frequency, route of administration, lot# and expiration date were not reported) or a dose of GARDASIL 9 (dose, frequency, route of administration, lot# and expiration date were not reported). It was unknown if product was GARDASIL or GARDASIL 9. On an unknown date, the patient experienced adverse event unspecified. The outcome of adverse event was unknown. The relatedness between the adverse event and therapy with GARDASIL or GARDASIL was not reported. This is one of six reports received from the same source.; Sender's Comments: US-009507513-1712USA014392: US-009507513-1712USA014393: US-009507513-1712USA014395: US-009507513-1712USA014396: US-009507513-1712USA013057:
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 20-DEC-2017, the patient was vaccinated with improperly stored dose of ZOSTAVAX lot number reported as N025701, expiration date reported as 16-DEC-2018 (dose, route and siute of administration were not reported) for prophylaxis. The sterile diluent (manufacturer unknown) was stored properly. The vaccine underwent a temperature excursion of 15 to 46 degrees Fahrenheit. No adverse event was reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1712USA014306:
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Body temperature increased, Ear pain, Headache, Peripheral swelling, Skin warm
Clinical narrative: Initial unsolicited report received from a patient on 03-Nov-2017. This case involves a 66-year-old female patient, who was vaccinated with first dose of 0.5 ml of FLUZONE HIGH DOSE once (batch number, expiry date, and administration site were not reported) via intramuscular route on 25-Oct-2017. The patient's medical history included allergy to erythromycin and concomitant medications were not reported. On 25-Oct-2017, same day evening, after the vaccination, the patient developed headache, on 26-Oct-2017, next morning at 6.00 a.m., following the vaccination, the patient woke up with severe pain on the whole left side of her head and her left ear was very painful to touch. Also reported that she stayed in bed for most of the next 4 days and continued to have severe headache, temperature of 101F, and right arm was swollen and hot to touch. On an unspecified day, the patient required visit to neurologist and was scheduled for an MRI. She did not receive any other vaccines that day. Other laboratory data and corrective treatment was not reported. Outcome of all the events were resolved after 4 days except headache, which was not recovered. List of documents held by sender: none.
Age: 37.0
Sex: M
Vaccine: FLU4
Symptoms: Muscular weakness, Myalgia
Clinical narrative: Patient complained of muscle pain radiating to elbow and up towards neck about 2-3 weeks after receiving flu injection. No pain or swelling immediately after shot. Also complains of right arm weakness. Was given 12 day prednisone taper which helped, but symptoms returned.
Age: 10.0
Sex: M
Vaccine: FLU4
Symptoms: Abnormal behaviour, Epistaxis, Petit mal epilepsy
Clinical narrative: Absent seizures, severe nose bleed, behavior challenge. The absent seizures lasted over night and into the next day. The nosebleeds that happened following that lasted the next two days. The behavioral challenges lasted 3-4 days. I believe that the reaction was the result of an ingredient in the vaccine that caused the events mentioned above. This is the same reaction that my son had when he accidentally ingested PlayDoh because it contained gluten, except for this reaction was worse.
Age: 80.0
Sex: M
Vaccine: FLU3
Symptoms: Death, Nausea, Sepsis, Vomiting
Clinical narrative: Began with nausea vomiting on 12/19/17- 12/20/17. He died of Sepsis per hospital on 12/27/17.
Age: 42.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Pneumonia, Sepsis
Clinical narrative: Patient claims he was hospitalized several days after receiving the immunizations with sepsis and pneumonia.
Age: 74.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Erythema, swelling of arm.
Age: 1.75
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Administration site swelling, Administration site warmth, Injection site erythema, Pyrexia
Clinical narrative: Redness and swelling at administration site. Warm to touch covering pt. whole thigh upper area. Pt. is running 100.6 fever.
Age: 37.0
Sex: F
Vaccine: FLU4, HEP, TDAP
Symptoms: Injection site pain, Injection site swelling, Pain
Clinical narrative: Received Tdap and Flu shot in left deltoid on 12/18/17. Approximately 1 week later starting on 12/25/17 experiencing pain at injection site when she moves her arm and pain when she tries to lift anything. Took TYLENOL and FLEXERIL and the ES TYLENOL lessens the pain. Injection site appears slightly swollen.
Age: 44.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician assistant and refers to a 44 year old patient of unknown gender. There was no information regarding the patient's medical history, concomitant medications, drug reactions and allergies provided. On 29-NOV-2017, the patient was vaccinated with PROQUAD, therapy type rHA, lot # M044575, expiration date 04-MAY-2018, for prophylaxis (dose and route of administration were not provided). Concomitant therapies included sterile diluent. The administered dose of PROQUAD was stored in the refrigerator from 18-OCT-2017, in temperature of 39 degrees Fahrenheit for 1008 hours (42 days). The call was because of digital data logger. There was no previous temperature excursion. No adverse effect was reported. This is one of a several reports received from the same reporter. Sender's Comments: US-009507513-1712USA014367: US-009507513-1712USA014360: US-009507513-1712USA014361: US-009507513-1712USA014362: US-009507513-1712USA014363: US-009507513-1712USA014364: US-009507513-1712USA014365: US-009507513-1712USA014366.
Age: 26.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician assistant and refers to a 26 year old patient of unknown gender. There was no information regarding the patient's medical history, concomitant medications, drug reactions and allergies provided. On 08-DEC-2017, the patient was vaccinated with PROQUAD, therapy type rHA, lot # M044575, expiration date 04-MAY-2018, for prophylaxis (dose and route of administration were not provided). Concomitant therapies included sterile diluent. The administered dose of PROQUAD was stored in the refrigerator from 18-OCT-2017, in temperature of 38 degrees Fahrenheit for 1224 hours (51 days). The call was because of digital data logger. There was no previous temperature excursion. No adverse effect was reported. This is one of a several reports received from the same reporter. Sender's Comments: US-009507513-1712USA009167.
Age: 43.0
Sex: U
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician assistant and refers to a 43 year old patient of unknown gender. There was no information regarding the patient's medical history, concomitant medications, drug reactions and allergies provided. On 08-DEC-2017, the patient was vaccinated with PROQUAD, therapy type rHA, lot # M044575, expiration date 04-MAY-2018, for prophylaxis (dose and route of administration were not provided). Concomitant therapies included sterile diluent. The administered dose of PROQUAD was stored in the refrigerator from 18-OCT-2017, in temperature of 38 degrees Fahrenheit for 1224 hours (51 days). The call was because of digital data logger. There was no previous temperature excursion. No adverse effect was reported. This is one of a several reports received from the same reporter. Sender's Comments: US-009507513-1712USA009167.
Age: 55.0
Sex: U
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician assistant and refers to a 55 year old patient of unknown gender. There was no information regarding the patient's medical history, concomitant medications, drug reactions and allergies provided. On 12-DEC-2017, the patient was vaccinated with PROQUAD, therapy type rHA, lot # M044575, expiration date 04-MAY-2018, for prophylaxis (dose and route of administration were not provided). Concomitant therapies included sterile diluent. The administered dose of PROQUAD was stored in the refrigerator from 18-OCT-2017, in temperature of 39 degrees Fahrenheit for 1320 hours (55 days). The call was because of digital data logger. There was no previous temperature excursion. No adverse effect was reported. This is one of a several reports received from the same reporter. Sender's Comments: US-009507513-1712USA009167.
Age: 38.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician assistant and refers to a 38 year old patient of unknown gender. There was no information regarding the patient's medical history, concomitant medications, drug reactions and allergies provided. On 12-DEC-2017, the patient was vaccinated with PROQUAD, therapy type rHA, lot # M044575, expiration date 04-MAY-2018, for prophylaxis (dose and route of administration were not provided). Concomitant therapies included sterile diluent. The administered dose of PROQUAD was stored in the refrigerator from 18-OCT-2017, in temperature of 39 degrees Fahrenheit for 1320 hours (55 days). The call was because of digital data logger. There was no previous temperature excursion. No adverse effect was reported. This is one of a several reports received from the same reporter. Sender's Comments: US-009507513-1712USA009167.
Sex: U
Vaccine: HPVX
Symptoms: Adverse event
Clinical narrative: This spontaneous report as received from a consumer refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On an unknown date, the patient was vaccinated with a dose of GARDASIL (dose, frequency, route of administration, lot# and expiration date were not reported) or a dose of GARDASIL 9 (dose, frequency, route of administration, lot# and expiration date were not reported). It was unknown if product was GARDASIL or GARDASIL 9. On an unknown date, the patient experienced adverse event unspecified. The outcome of adverse event was unknown. The relatedness between the adverse event and therapy with GARDASIL or GARDASIL was not reported. This is one of six reports received from the same source.; Sender's Comments:  US-009507513-1712USA013057: US-009507513-1712USA014393: US-009507513-1712USA014394: US-009507513-1712USA014395: US-009507513-1712USA014396:
Sex: U
Vaccine: HPVX
Symptoms: Adverse event
Clinical narrative: This spontaneous report as received from a consumer refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On an unknown date, the patient was vaccinated with a dose of GARDASIL (dose, frequency, route of administration, lot# and expiration date were not reported) or a dose of GARDASIL 9 (dose, frequency, route of administration, lot# and expiration date were not reported). It was unknown if product was GARDASIL or GARDASIL 9. On an unknown date, the patient experienced adverse event unspecified. The outcome of adverse event was unknown. The relatedness between the adverse event and therapy with GARDASIL or GARDASIL was not reported. This is one of six reports received from the same source.; Sender's Comments: US-009507513-1712USA014392: US-009507513-1712USA014393: US-009507513-1712USA014394: US-009507513-1712USA014396: US-009507513-1712USA013057:
Sex: U
Vaccine: HPVX
Symptoms: Adverse event
Clinical narrative: This spontaneous report as received from a consumer refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On an unknown date, the patient was vaccinated with a dose of GARDASIL (dose, frequency, route of administration, lot# and expiration date were not reported) or a dose of GARDASIL 9 (dose, frequency, route of administration, lot# and expiration date were not reported). It was unknown if product was GARDASIL or GARDASIL 9. On an unknown date, the patient experienced adverse event unspecified. The outcome of adverse event was unknown. The relatedness between the adverse event and therapy with GARDASIL or GARDASIL 9 was not reported. This is one of six reports received from the same source. Sender's Comments: US-009507513-1712USA014392: US-009507513-1712USA014393: US-009507513-1712USA014394: US-009507513-1712USA014395: US-009507513-1712USA013057.
Age: 14.0
Sex: F
Vaccine: FLU4
Symptoms: Dysphagia, Lacrimation increased, Ocular hyperaemia, Throat irritation
Clinical narrative: Initial unsolicited report received from health professional (medical doctor) on 13-Dec-2017. This case involves a female patient of unknown age who was vaccinated with a gradient dose of 0.2ml dose of  FLUZONE QUADRIVALENT injection (batch number: UT5937LA, expiry date, route and site of administration were not reported) on 28-Oct-2017. Patient medical history and concomitant medications were not reported. On 28-Oct-2017, same day with in minutes following the vaccination, the patient experienced itchy throat, difficulty in swallowing, and red, watery eyes. Patient past medical history included flu vaccine of large local reaction and also 0.05 ml dilution dose, 0.05 ml full strength dose, 0.1 ml full strength dose and a 0.15 ml full strength dose of FLUZONE QIV vaccine. Lab data and corrective treatment were not reported. The outcome of the all events were unknown at the time of reporting. It was an actual medication error case due to wrong injection technique and vaccine under dose. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Sex: F
Vaccine: FLUX
Symptoms: Pain
Clinical narrative: Initial unsolicited report received from a Nurse on 15-Dec-2017. This case involves a female patient (age was not reported) who was vaccinated with a dose of INFLUENZA VACCINE (DID NOT SPECIFY WHICH BRAND) (Batch number, expiration date, dose, dose in series, route and site of administration were not reported) on an unknown date. Patient's ongoing illness, medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient experienced aches and pain. Laboratory investigations and corrective treatment were not reported. The outcome of event was not reported. List of documents held by sender: none.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Lip swelling, Throat irritation, Urticaria
Clinical narrative: Approx. 3 hours post vaccination patient began to develop hives on the LEFT side of face extending along jaw-line from chin to eyebrow. Started with scratchy throat and swelling of her lips. Patient immediately self administered 50 mg PO Benadryl, responded well to treatment.
Age: 54.0
Sex: M
Vaccine: FLU4
Symptoms: Facial paralysis
Clinical narrative: Patient developed Bell's Palsy.
Age: 30.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash, Rash erythematous, Rash pruritic, Varicella post vaccine
Clinical narrative: Vaccine induced Varicella disease. Patient presented 14 days after Varicella # 1 with rash on arms, neck and chest. Raised red and itchy areas. No fever or other symptoms. Dr. evaluated Patient and confirmed Varicella disease. Patient instructed to take Benadryl for itch and call back with any concerns or questions.
Age: 4.0
Sex: F
Vaccine: HEP
Symptoms: Vaccination error
Clinical narrative: Immunization error.
Age: 78.0
Sex: M
Vaccine: FLUC4, PNC13
Symptoms: Dizziness, Syncope
Clinical narrative: Light headed, fainted in pharmacy.
Age: 65.0
Sex: M
Vaccine: MNQ
Symptoms: Culture negative, Erythema
Clinical narrative: Left arm erythema, possible Allergic reaction to vaccine. Improving redness on left arm and anterior chest. Cultures neg. Abx narrowed to doxycycline per ID.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Facial paralysis
Clinical narrative: Patient reported paralysis of the right side of the face.
Age: 33.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site vesicles, Injection site warmth
Clinical narrative: Left upper arm swelling 10.5X9.5 to, red, warm to touch, itchy, small blisters. Denies any fever, SOB or rash to other parts of the body.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Insomnia, Pain in extremity
Clinical narrative: PAIN AT THE INJECTION SITE DEVELOPED A FEW HOURS AFTER VACCINE ADMINISTRATION. THE PATIENT TOOK ADVIL FOR PAIN RELIEF AND THE PAIN RESOLVED FOR THAT DAY. THE DAY AFTER VACCINE ADMINISTRATION THE PAIN RETURNED AND THE PATIENT COULDN'T SLEEP BECAUSE OF THE PAIN. TODAY (2 DAYS AFTER VACCINE ADMINISTRATION) THE PATIENT STILL REPORTS PAIN IN THE WHOLE ARM BUT A KIND OF BEATING/PULSATING PAIN.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Alopecia, Cough, Dysphonia, Pyrexia, Throat irritation
Clinical narrative: Within 24 hours fever> 100 (normal pt temp 97.8), hives, scratchy throat, deep cough. Longer lasting  effects, hair loss (more on left side), scratchy voice, hair loss.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Within 24 hours fever> 100 (normal pt temp 97.8), hives, scratchy throat, deep cough. Longer lasting  effects, hair loss (more on left side), scratchy voice, hair loss.
Age: 29.0
Sex: F
Vaccine: HPV4
Symptoms: Asthenia, Dizziness, Feeling abnormal, Nervous system disorder
Clinical narrative: Severe dizziness and weakness right after the vaccination. Foggy brain, light headed, nerves problem since then.
Age: 61.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report was received from a pharmacist referring to a 61 year old male patient. The patient had no pertinent medical history, neither drug reaction/allergies. On 29-NOV-2017, the patient was vaccinated with a dose of PNEUMOVAX 23 lot # N020502, expiring on 08-FEB-2019 intramuscularly in an unspecified location no in deltoid (strength, dosage schedule and indication were not provided). There were no concomitant medications. On 29-NOV-2017, the patient experienced injection site swelling and injection site erythema which began after the injection. No lab tests were performed. On 30-NOV-2017, the patient returned to the pharmacy seeking for medical attention. The patient was scheduled for return to the pharmacy on 01-DEC-2017 to follow up on recovery. The outcome of injection site swelling and injection site erythema was reported as recovering. The causal relationship between PNEUMOVAX 23 and the aforementioned events, was not reported.
Age: 1.33
Sex: F
Vaccine: HIBV, MMR, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a Registered Nurse and refers to a 16 month old female patient with no per-existing allergies, birth defects or medical conditions. The patient's concomitant therapies was not reported. On 01-DEC-2017 at 10:30 am, an alarm was noted on log tag. It was reported to company representative and State Immunization Program, after excursion amount of time the reporter was told she could use the vaccine until normal expiration date. It was reported that within 4 weeks prior the vaccination the patient did not receive any other vaccine and she did not present any illness at the time of vaccination. On 01-DEC-2017 at 02:22 pm, the patient was vaccinated with improperly stored doses of VARIVAX first dose, subcutaneously lot # N010107, expiration date 18-MAR-2019, also reported as 28-MAR-2019, in the right arm, M-M-R II first dose, subcutaneously lot # M045392, expiration date 17-NOV-2018, in the left arm, and PEDVAXHIB dose fourth, intramuscularly lot # N081149, expiration date not reported, in the left thigh, for prophylaxis  (doses were not reported for any vaccine). On 25-DEC-2017, a telephone call to the mother's child was made for evaluation of any adverse reaction to immunization, the patient's mother stated that the child did very good and she didn't run a fever or anything. VARIVAX was exposed to a temperature excursion of 6 F to 14 F for a time frame of 2 hours which were call because of a data logger. This is one of several reports received from the same reporter (case: 1712USA013941).
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. No information was provided regarding the patient's medical, drug and allergy history or concurrent conditions. On 30-NOV-2017, the patient was vaccinated with ZOSTAVAX 19400 PFU lot # N022035 and expiration date 11-NOV-2018 intradermally rather than the recommended subcutaneous route, for prophylaxis. No adverse reactions were reported.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Headache, Injection site erythema, Injection site swelling, Mass, Pain
Clinical narrative: This spontaneous report was received from a 71 year old female consumer, referring herself. The patient had no a pertinent medical history or concomitant medications. The patient had an allergy to sulfur drugs. On 27-NOV-2017, the patient was vaccinated with PNEUMOVAX 23, dose reported as "1 rod inserted" as a shot under her shoulder (route, lot number and expiration date were unknown by the reporter) for prophylaxis. On 28-NOV-2017, after receiving the vaccine, the patient experienced pains, headaches, itching, "20 pumps the size of a peas", injection site swelling and redness. The patient followed up with her physician who prescribed her BENADRYL tablets. No laboratories were performed for the events. The outcome of skin mass, injection site erythema, injection site swelling, pruritus, headache, and pain was reported as not yet recovered. The causality assessment between the events and the suspect therapy was not reported.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Pruritus
Clinical narrative: This spontaneous report was received from a 71 year old female consumer, referring herself. The patient had no a pertinent medical history or concomitant medications. The patient had an allergy to sulfur drugs. On 27-NOV-2017, the patient was vaccinated with PNEUMOVAX 23, dose reported as "1 rod inserted" as a shot under her shoulder (route, lot number and expiration date were unknown by the reporter) for prophylaxis. On 28-NOV-2017, after receiving the vaccine, the patient experienced pains, headaches, itching, "20 pumps the size of a peas", injection site swelling and redness. The patient followed up with her physician who prescribed her BENADRYL tablets. No laboratories were performed for the events. The outcome of skin mass, injection site erythema, injection site swelling, pruritus, headache, and pain was reported as not yet recovered. The causality assessment between the events and the suspect therapy was not reported.
Age: 57.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site erythema, Pain in extremity, Skin warm
Clinical narrative: REDNESS FROM SIGHT OF INJECTION TO BASE OF ARM, NEAR THE ELBOW. PAIN RADIATING DOWN TO THE HAND. HOT/WARM TO THE TOUCH AND FEEL OF THE PATIENT.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Nuclear magnetic resonance imaging normal, Pain in extremity, Paraesthesia
Clinical narrative: On 10/17/17--14 days after injection patient called and complained of arm soreness and tingling in fingers. Patient was advised to see her dr. Patient came into pharmacy 12/23/2017 stating she received prednisone from dr's visit and also seen ortho Dr--MRI showed up normal according to patient. Present time patient states arm feels much better.
Age: 8.0
Sex: M
Vaccine: HEP, HEPA, IPV, TDAP, VARCEL
Symptoms: Dyspnoea
Clinical narrative: While an 8 year old patient who had received Varicella for the first time had been sitting  his mother alerted clerical staff that the child was having trouble breathing. Upon assessment the checklist for previous reactions or contraindications were all negative with previous vaccines. The child was immediately taken to the back and placed on exam table for assessment. Breath sounds were clear with no stridor or rales noted. O2 sat was 96%. O2 was administered at 6L/mask. Mom was at the bedside with information being related through the HD translator. Mom told translator the child has asthma and she thought he just got upset over getting shots. Ventolin was given X 6 puffs per metered dose inhaler. EMS was called and assessed child and found him to be stable. 02 sats and vital signs were repeated after 02 had been removed and 02 sats remained at 99% on room air. Patient was watched for an additional 20 minutes after EMS left and was alert and oriented, RR regular and non-labored. Discharged to home per private vehicle with mother. Attempted follow up phone call to the phone number given, but they were not receiving calls.
Age: 1.5
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Drug hypersensitivity
Clinical narrative: Benadryl allergy oral Liquid 12.5mg/5ml.
Age: 56.0
Sex: F
Vaccine: FLUR3
Symptoms: Arthritis, Crying, Discomfort, Hypotonia, Immediate post-injection reaction
Clinical narrative: Uncomfortable, a nuisance or irritation, but able to carry on with everyday activities, Had short-term effect that was bad enough to affect everyday activities, Significant enough to lead you to seek advice from a healthcare professional. After being administered a flu shot, my left arm was immediately limp. The pain was so horrible, I cried out. It felt like a nerve was punctured and my shoulder was hot and swollen two times bigger. Dr. recognized the discomfort and made me stay in the room for several minutes. My arm remained inflamed so I went to the ER that evening. After no luck, I went to my physician and explained my discomfort was prescribed pain medication. Not feeling better, my physician request an MRI and it was that I had arthritis. No onset arthritis was apart of my medical record. I am still in pain. I am suffering and I truly feel it was because of the flu shot. A second optioned was a request by another physician next week.
Age: 56.0
Sex: F
Vaccine: FLUR3
Symptoms: Inflammation, Loss of personal independence in daily activities, Nuclear magnetic resonance imaging abnormal, Pain, Skin warm
Clinical narrative: Uncomfortable, a nuisance or irritation, but able to carry on with everyday activities, Had short-term effect that was bad enough to affect everyday activities, Significant enough to lead you to seek advice from a healthcare professional. After being administered a flu shot, my left arm was immediately limp. The pain was so horrible, I cried out. It felt like a nerve was punctured and my shoulder was hot and swollen two times bigger. Dr. recognized the discomfort and made me stay in the room for several minutes. My arm remained inflamed so I went to the ER that evening. After no luck, I went to my physician and explained my discomfort was prescribed pain medication. Not feeling better, my physician request an MRI and it was that I had arthritis. No onset arthritis was apart of my medical record. I am still in pain. I am suffering and I truly feel it was because of the flu shot. A second optioned was a request by another physician next week.
Age: 56.0
Sex: F
Vaccine: FLUR3
Symptoms: Swelling, Tendonitis
Clinical narrative: Uncomfortable, a nuisance or irritation, but able to carry on with everyday activities, Had short-term effect that was bad enough to affect everyday activities, Significant enough to lead you to seek advice from a healthcare professional. After being administered a flu shot, my left arm was immediately limp. The pain was so horrible, I cried out. It felt like a nerve was punctured and my shoulder was hot and swollen two times bigger. Dr. recognized the discomfort and made me stay in the room for several minutes. My arm remained inflamed so I went to the ER that evening. After no luck, I went to my physician and explained my discomfort was prescribed pain medication. Not feeling better, my physician request an MRI and it was that I had arthritis. No onset arthritis was apart of my medical record. I am still in pain. I am suffering and I truly feel it was because of the flu shot. A second optioned was a request by another physician next week.
Age: 71.0
Sex: M
Vaccine: FLUR3
Symptoms: Erythema, Hypoaesthesia, Hypoaesthesia oral, Rash
Clinical narrative: Skin rash and numbness in tongue and left face, facial erythema.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain, Peripheral swelling, Skin warm
Clinical narrative: Evening of 12/27 she noticed redness, swelling to inner and outer upper arm. She reported pain to touch, warm to touch. Pt tried ice packs. OTC allergy meds, anti-inflammatory with no relief.
Age: 61.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Erythema, Inflammation, Swelling, Vomiting
Clinical narrative: Swelling, redness, inflammation, vomiting.
Age: 17.0
Sex: F
Vaccine: FLU4, MENB
Symptoms: Face injury, Lip injury, Loss of consciousness, Syncope, Tooth fracture
Clinical narrative: Upon giving flu shot, pt collapsed and fell onto face from exam table. Laceration to lower lip and 2 incisor teeth broken. 2 min after when she regained consciousness assessed by Dr. Pt to go to ER for evaluation.
Age: 22.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: 16.5 cm x 13.5 cm reaction at injection site, redness, swelling, and itching.
Age: 0.33
Sex: F
Vaccine: DTAP
Symptoms: Crying, Pyrexia
Clinical narrative: Fever over 101 and uncontrollable crying for hours.
Age: 75.0
Sex: F
Vaccine: FLUA3
Symptoms: Injection site erythema, Injection site pruritus, Injection site reaction, Rash macular, Swelling face
Clinical narrative: Splotchy red areas at vaccination site, itchy. Face swelling, no trouble breathing noted.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Pyrexia
Clinical narrative: Fever of 101 deg F at 9pm, given 2.5mL Infant TYLENOL. No fever when rechecked at 6am the next day.
Age: 16.0
Sex: F
Vaccine: UNK
Symptoms: Dizziness, Feeling cold, Musculoskeletal discomfort, Myalgia, Pyrexia
Clinical narrative: Fever, chills, still neck, lightheaded sore muscles.
Age: 78.0
Sex: M
Vaccine: PPV
Symptoms: Dizziness, Injection site discomfort, Muscle spasms
Clinical narrative: Patient felt lightheaded while walking out of the store 5 minutes after receiving PNEUMOVAX injection. While he went to sit down on the floor, he felt his back muscles spasm. Patient then lied down on the floor. Lightheadedness immediately resolved, but back muscles continued to spasm for several minutes (~5 min). Patient also reported discomfort radiating from site of injection on left arm. I provided the patient water, which he drank a few sips of. Patient continued to lay prone on floor for about 7-10 minutes and then stood up and felt better. I walked with him to the pharmacy waiting area, where he sat in a chair for another 10 minutes. Patient refused my recommendation to call an ambulance. He also refused my offers to call a family member or a taxi service. Patient walked out after stating he felt fine to leave.
Age: 59.0
Sex: M
Vaccine: FLUC4
Symptoms: Tremor
Clinical narrative: Patient called the pharmacy on 12/30/17 at 9:10 AM. Patient reports his hands will not stop shaking. I referred patient to contact MD. Patient states he refuses to go to hospital where he can seek medical attention. I informed patient that I am not sure of other options for medical attention, but repeated that I recommend you speak to a physician.
Age: 76.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling
Clinical narrative: PT CAME IN TODAY, DECEMBER 30TH (2 DAYS AFTER RECEIVING VACCINE) AND SAID HE HAD QUESTIONS ABOUT THE SHOT HE HAD GOTTEN. HE STATED THAT LATER THE SAME DAY AS RECEIVING THE VACCINE HIS ARM TURNED RED AND WAS SWOLLEN "THREE SIZES LARGER THAN NORMAL". I LOOKED AT HIS ARM TODAY AND THERE IS A RED SWOLLEN AREA ON THE INSIDE OF HIS RIGHT ARM AND HE SAID THE AREA HAD BEEN SPREADING DOWN HIS ARM TOWARD HIS HAND BUT WAS BETTER THAN IT WAS. I ASKED THE PT IF HE HAD A NORMAL DOCTOR BUT HE DOES NOT; I TRIED CALLING THE MERCK VACCINE HOTLINE BUT THEY ARE CLOSED UNTIL AFTER THE NEW YEAR'S HOLIDAY. INSTRUCTED THE PT HE COULD TAKE SOME IBUPROFEN OR TYLENOL IF NEEDED BUT IF IT GOT ANY WORSE TO GO TO THE LOCAL WALK IN CLINIC. I ALSO TOLD THE PT I WOULD CALL MERCK WHEN THEY OPEN BACK UP ON JANUARY 2ND AND GIVE HIM A CALL TO CHECK ON HIM.
Age: 69.0
Sex: M
Vaccine: FLUA3, VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site urticaria, Injection site warmth
Clinical narrative: Patient reported no initial reaction, however, the following morning injection site redness, swelling, welting, hot feeling began. The reported symptoms have continued for 3 days post-injection at this time.
Age: 67.0
Sex: F
Vaccine: TDAP
Symptoms: Blister, Rash erythematous
Clinical narrative: Within a few hours of injection, I noticed a rash in the lower middle of my back. The next day, the rash had spread to the midsection of my body. Rash are red with small blisters. This is day 3 of the injection and the rash remains.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Dyspnoea, Hypersomnia, Hyporesponsive to stimuli, Pyrexia
Clinical narrative: V. high fever >104, Labored breathing, Decreased responsiveness, Excessive sleepiness.
Age: 16.0
Sex: F
Vaccine: HEPA, HPV9
Symptoms: Fall
Clinical narrative: After sitting for 5 minutes, patient stood up and walked 8 feet to her father. Patient was standing next to father, fell forward into him, then lost control and fell backwards. Patient did not lose consciousness at any time.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Patient came back one day after receiving the vaccine to show the inject site. The injection site seemed red, swollen, and warm to touch. Patient stated that the injection site was itchy.
Age: 81.0
Sex: M
Vaccine: PPV
Symptoms: Decreased appetite, Fatigue, Headache, Injection site erythema, Injection site swelling
Clinical narrative: Headache, Malaise, Extreme fatigue, Loss of appetite, somnolence, mood chages (lasted 48 hours)  Severe redness and swelling of injection arm all the way from the shoulder to the elbow. Redness and swelling still persists on day 3 (Dec 30th).
Age: 81.0
Sex: M
Vaccine: PPV
Symptoms: Malaise, Mood altered, Somnolence
Clinical narrative: Headache, Malaise, Extreme fatigue, Loss of appetite, somnolence, mood chages (lasted 48 hours)  Severe redness and swelling of injection arm all the way from the shoulder to the elbow. Redness and swelling still persists on day 3 (Dec 30th).
Age: 82.0
Sex: M
Vaccine: FLUA3
Symptoms: Inflammation, Pain in extremity, Peripheral swelling
Clinical narrative: Patient claims extreme pain and swelling of the hand and forearm area to the point where he had to seek medical treatment at a short wait clinic. Injection site was not involved according to patient. Was given prednisone for inflammation. Pt. recovered without further treatment.
Age: 53.0
Sex: M
Vaccine: FLUC4
Symptoms: Ankle fracture, Blood test, Chest X-ray, Computerised tomogram, Dyspnoea
Clinical narrative: Numbness and tingling in hands and feet began on December 8, 2017. 12/9 symptoms worsened and patient went to ER. Suspected Guillain Barré syndrome. Told to go home and come back if symptoms worsened. 12/10 symptoms worse, while preparing to go to ER patient fell and broke his ankle. On Tuesday, 12/12 patient started treatments for GBS. By Thursday 12/14 patient had lost use of legs, very limited use of arms and issues with facial muscles. On 12/20 patient released from hospital to rehab. On Saturday 12/23 patient experienced trouble breathing and was taken back to Hospital where he was intubation. As of 12/30 he is still incubated and in CCU.
Age: 53.0
Sex: M
Vaccine: FLUC4
Symptoms: Endotracheal intubation, Fall, Guillain-Barre syndrome, Hypoaesthesia, Intensive care
Clinical narrative: Numbness and tingling in hands and feet began on December 8, 2017. 12/9 symptoms worsened and patient went to ER. Suspected Guillain Barré syndrome. Told to go home and come back if symptoms worsened. 12/10 symptoms worse, while preparing to go to ER patient fell and broke his ankle. On Tuesday, 12/12 patient started treatments for GBS. By Thursday 12/14 patient had lost use of legs, very limited use of arms and issues with facial muscles. On 12/20 patient released from hospital to rehab. On Saturday 12/23 patient experienced trouble breathing and was taken back to Hospital where he was intubation. As of 12/30 he is still incubated and in CCU.
Age: 53.0
Sex: M
Vaccine: FLUC4
Symptoms: Lumbar puncture, Muscle disorder, Musculoskeletal disorder, Nuclear magnetic resonance imaging brain, Nuclear magnetic resonance imaging spinal
Clinical narrative: Numbness and tingling in hands and feet began on December 8, 2017. 12/9 symptoms worsened and patient went to ER. Suspected Guillain Barré syndrome. Told to go home and come back if symptoms worsened. 12/10 symptoms worse, while preparing to go to ER patient fell and broke his ankle. On Tuesday, 12/12 patient started treatments for GBS. By Thursday 12/14 patient had lost use of legs, very limited use of arms and issues with facial muscles. On 12/20 patient released from hospital to rehab. On Saturday 12/23 patient experienced trouble breathing and was taken back to Hospital where he was intubation. As of 12/30 he is still incubated and in CCU.
Age: 53.0
Sex: M
Vaccine: FLUC4
Symptoms: Nuclear magnetic resonance imaging thoracic, Paraesthesia, Ultrasound scan
Clinical narrative: Numbness and tingling in hands and feet began on December 8, 2017. 12/9 symptoms worsened and patient went to ER. Suspected Guillain Barré syndrome. Told to go home and come back if symptoms worsened. 12/10 symptoms worse, while preparing to go to ER patient fell and broke his ankle. On Tuesday, 12/12 patient started treatments for GBS. By Thursday 12/14 patient had lost use of legs, very limited use of arms and issues with facial muscles. On 12/20 patient released from hospital to rehab. On Saturday 12/23 patient experienced trouble breathing and was taken back to Hospital where he was intubation. As of 12/30 he is still incubated and in CCU.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Patient came to the pharmacy complaining of a sore and stiff arm with limited mobility following the administration of a flu vaccine. No swelling or discoloration was noted. It was advised that she schedule an appointment with her primary care provider for further evaluation.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Contusion, Pain, Swelling
Clinical narrative: PATIENT RECEIVED INJ. ON 11/20/2017 AND ON 11/21/2017 STARTED TO HAVE BRUISING, SWELLING AND PAIN. WAS TOLD TO USE WARM PACKS AND TAKE IBUPROFEN, CONTINUED THIS OFF AND ON BUT STILL HAS PAIN AND SOME BRUISING ON 12/30/2017.  WILL BE SEEING DOCTOR SOON.
Age: 63.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Administration site rash
Clinical narrative: Patient report red rash about the size of a quarter approximately 1 week after injection. Benadryl was administered by patient.
Age: 63.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Rash erythematous
Clinical narrative: Patient report red rash about the size of a quarter approximately 1 week after injection. Benadryl was administered by patient.
Age: 0.75
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Condition aggravated, Dehydration, Upper respiratory tract infection, Vomiting
Clinical narrative: WITHIN 48 HOURS OF INJECTION, UPPER RESPIRATORY INFECTION FAILED TO RESOLVE AND CONTINUED TO PROGRESS, AND NEW SYMPTOMS ONSET AT 48 HOURS EXACTLY, INCLUDING INTRACTABLE VOMITING WITH DEHYDRATION REQUIRING ASSESSMENT AND EVALUATION AND TREATMENT (INCLUDING MEDICATION) IN AN EMERGENCY DEPARTMENT.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Headache, Injection site pain, Pain
Clinical narrative: Pt c/o chills, body aches, injection site pain, and headache 1 day after vaccine administration. Seen in clinic the following day- symptoms have resolved.
Age: 51.0
Sex: F
Vaccine: FLUR3
Symptoms: Mycobacterium tuberculosis complex test
Clinical narrative: Knots under right arm and under both collarbones. Started on right side the next day and went to the left side 2-3 days later.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Fall, Headache, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient was nauseous evening after getting vaccine. The next morning she woke up and was still nauseous, had a headache and turned "gray" and then fainted. She did not report any injury from fall and woke up. The arm below the injection site was red and hot/swollen the same day and the swelling decreased slightly with Benadryl she took at home. Patient went to doctor the next day and received prescriptions for prednisone and Benadryl. Two days after vaccine patient still has some swelling and redness.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Nausea, Skin discolouration, Syncope
Clinical narrative: Patient was nauseous evening after getting vaccine. The next morning she woke up and was still nauseous, had a headache and turned "gray" and then fainted. She did not report any injury from fall and woke up. The arm below the injection site was red and hot/swollen the same day and the swelling decreased slightly with Benadryl she took at home. Patient went to doctor the next day and received prescriptions for prednisone and Benadryl. Two days after vaccine patient still has some swelling and redness.
Age: 80.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Oedema peripheral, Peripheral swelling, Pruritus
Clinical narrative: Patient presented with large swelling on the injection arm and edema in the posterior forearm (especially significant when compared to her right forearm). She had not tried anything 2 days out when she came to the store. It was recommended she call her doctor right away, and if the swelling/itching got any worse to visit the nearest ER or immediate care clinic for further treatment. She was advised to use an antihistamine such as BENADRYL or ZYRTEC (she reported no other medications). Upon follow-up the next day, the patient reported the itching/swelling had not gotten worse and seemed to be improving. Two days later she reported all symptoms were gone and she was back to normal.
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus, Urticaria, Vaccination complication
Clinical narrative: Patient developed hives and pruritus secondary to influenza vaccine. Patient was instructed to take BENADRYL. Symptoms are remitting.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Acne, Burning sensation, Dry skin, Eye irritation, Lacrimation increased
Clinical narrative: Over 65 influenza vaccine: within 24 hours had breakout of acne and dry peeling skin on face. Symptoms seem to subside, then on day 10 eyes watering. Followed by swollen glands, low fever, severe congestion, burning eyes and sinuses, nasal drainage. Obtained relief with old expired penicillin, each day better. Recovery in process.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Lymphadenopathy, Pyrexia, Respiratory tract congestion, Rhinorrhoea, Skin exfoliation
Clinical narrative: Over 65 influenza vaccine: within 24 hours had breakout of acne and dry peeling skin on face. Symptoms seem to subside, then on day 10 eyes watering. Followed by swollen glands, low fever, severe congestion, burning eyes and sinuses, nasal drainage. Obtained relief with old expired penicillin, each day better. Recovery in process.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Fatigue, Feeling hot, Malaise, Pain in extremity
Clinical narrative: Pain, swelling of entire upper arm from shoulder to elbow, with red boundary line at bend of elbow, redness, heat, general malaise, unusual tiredness.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Peripheral swelling
Clinical narrative: Pain, swelling of entire upper arm from shoulder to elbow, with red boundary line at bend of elbow, redness, heat, general malaise, unusual tiredness.