chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 10-OCT-2012 the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 01-JAN-2013 the patient was treated by a physician for the onset of severe vesicular rash accompanied by a weakened immune symptoms, which was diagnosed as severe herpes zoster. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment.  As further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a Licensed practical nurse regarding a patient of unknown age and gender. The patient's medical history, drug allergies, previous drug reactions, concurrent conditions and concomitant medication were not reported. On 08-JAN-2018, the patient was vaccinated with an improperly stored dose of GARDASIL 9 lot number N020352 with expiration date in 10-APR-2020 (strength, anatomical location and route of administration were not provided) for prophylaxis. The GARDASIL 9 was stored at a temperature range of 0 Celsius degrees (°C) to 1°C for the time frame of 75 minutes, and another temperature range of 2°C to 8°C (1.9°C) for the time frame of 6 minutes. The call was because of a data logger. No adverse effects reported.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Fall, Gait disturbance, Mobility decreased, Muscular weakness, Myelitis transverse
Clinical narrative: This spontaneous report was received from a physician assistant via a company representative and refers to a 12-year-old female patient. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 09-AUG-2015, the patient was vaccinated with the first dose of GARDASIL intramuscularly, (dose, frequency, lot# and expiration date were not reported). On 02-MAY-2017, the patient was vaccinated with the second dose of GARDASIL intramuscularly, (dose, lot# and expiration date were not reported). On an unknown date, sometime after the first dose of the vaccine, the patient experienced muscle weakness, transverse mylasia and difficulty moving foot causing her to stumble and fall. It was reported that symptoms had worsened over the years period, on unknown dates. The events of muscle weakness, transverse mylasia and difficulty moving foot causing the patient to stumble and fall were reported as significant disability. The patient sought medical attention and was currently, at the time of this report, under a doctors care, she was given an unspecified treatment but she was not hospitalized. The outcome of muscle weakness, transverse mylasia and difficulty moving foot causing the patient to stumble and fall was not recovered at the time of this report. The relatedness between the events and GARDASIL was not reported. Upon internal review, the event of transverse mylasia was considered to be medically significant.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. The patient's historical drugs, medical history, concomitant therapies, drugs allergies and concurrent conditions were not reported. On 20-NOV-2017, the patient was vaccinated with an improperly stored dose of PROQUAD lot # N016994, expiration date 29-NOV-2018, for prophylaxis (strength, dose, route and frequency were not reported). The PROQUAD was reconstituted with a properly stored sterile diluent (MERCK) lot # M034763, expiration date 22-APR-2019. The temperature excursion was of 6°F to 14°F, during 120 hours 30 minutes. However, a previous temperature excursion of 47°F to 50°F for 35 minutes was also reported. A digital data logger was involved. No adverse effects were reported. Additional information is not expected. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1712USA013991: US-009507513-1801USA003522: US-009507513-1801USA003523: US-009507513-1801USA003524: US-009507513-1801USA003525: US-009507513-1801USA003526: US-009507513-1801USA003527: US-009507513-1801USA003521: US-009507513-1801USA003612.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. The patient's historical drugs, medical history, concomitant therapies, drugs allergies and concurrent conditions were not reported. On 30-NOV-2017, the patient was vaccinated with an improperly stored dose of PROQUAD lot # N016994, expiration date 29-NOV-2018, for prophylaxis (strength, dose, route and frequency were not reported). The PROQUAD was reconstituted with a properly stored sterile diluent (MERCK) lot # M034763, expiration date 22-APR-2019. The temperature excursion was of 6°F to 14°F, during 120 hours 30 minutes. However, a previous temperature excursion of 47°F to 50°F for 35 minutes was also reported. A digital data logger was involved. No adverse effects were reported. Additional information is not expected. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1712USA013991: US-009507513-1801USA003520: US-009507513-1801USA003527: US-009507513-1801USA003522: US-009507513-1801USA003523: US-009507513-1801USA003524: US-009507513-1801USA003525: US-009507513-1801USA003526: US-009507513-1801USA003612.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. The patient's historical drugs, medical history, concomitant therapies, drugs allergies and concurrent conditions were not reported. On 01-DEC-2017, the patient was vaccinated with an improperly stored dose of PROQUAD lot # N016994, expiration date 29-NOV-2018, for prophylaxis (strength, dose, route and frequency were not reported). On 04-DEC-2017, the patient was vaccinated with an improperly stored dose of PROQUAD lot # N016994, expiration date 29-NOV-2018, for prophylaxis (strength, dose, route and frequency were not reported). The both PROQUAD was reconstituted with a properly stored sterile diluent (MERCK STERILE DILUENT) lot # M034763, expiration date 22-APR-2019. The temperature excursion was of 6°F to 14°F, during 120 hours 30 minutes. However, a previous temperature excursion of 47 °F to 50°F for 35 minutes was also reported. A digital data logger was involved. No adverse effects were reported. Additional information is not expected. This is one of several reports received from  the same reporter.; Sender's Comments: US-009507513-1712USA013991: US-009507513-1801USA003523: US-009507513-1801USA003524: US-009507513-1801USA003525: US-009507513-1801USA003526: US-009507513-1801USA003527: US-009507513-1801USA003521: US-009507513-1801USA003520: US-009507513-1801USA003612 :
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. The patient's historical drugs, medical history, concomitant therapies, drugs allergies and concurrent conditions were not reported. On 04-DEC-2017, the patient was vaccinated with an improperly stored dose of PROQUAD lot # N016994, expiration date 29-NOV-2018, for prophylaxis (strength, dose, route and frequency were not reported). The PROQUAD was reconstituted with a properly stored sterile diluent (MERCK) lot # M034763, expiration date 22-APR-2019. The temperature excursion was of 6°F to 14°F, during 120 hours 30 minutes. However, a previous temperature excursion of 47 °F to 50°F for 35 minutes was also reported. A digital data logger was involved. No adverse effects were reported. Additional information is not expected. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1712USA013991: US-009507513-1801USA003524: US-009507513-1801USA003525: US-009507513-1801USA003526: US-009507513-1801USA003527: US-009507513-1801USA003520: US-009507513-1801USA003521: US-009507513-1801USA003522: US-009507513-1801USA003612.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. The patient's historical drugs, medical history, concomitant therapies, drugs allergies and concurrent conditions were not reported. On 04-DEC-2017, the patient was vaccinated with an improperly stored dose of PROQUAD lot # N016994, expiration date 29-NOV-2018, for prophylaxis (strength, dose, route and frequency were not reported). The PROQUAD was reconstituted with a properly stored sterile diluent (MERCK) lot # M034763, expiration date 22-APR-2019. The temperature excursion was of 6°F to 14°F, during 120 hours 30 minutes. However, a previous temperature excursion of 47°F to 50°F for 35 minutes was also reported. A digital data logger was involved. No adverse effects were reported. Additional information is not expected. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1712USA013991: US-009507513-1801USA003525: US-009507513-1801USA003526: US-009507513-1801USA003527: US-009507513-1801USA003520: US-009507513-1801USA003521: US-009507513-1801USA003522: US-009507513-1801USA003523: US-009507513-1801USA003612.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. The patient's historical drugs, medical history, concomitant therapies, drugs allergies and concurrent conditions were not reported. On 07-DEC-2017, the patient was vaccinated with an improperly stored dose of PROQUAD lot # N016994, expiration date 29-NOV-2018, for prophylaxis (strength, dose, route and frequency were not reported). The PROQUAD was reconstituted with a properly stored sterile diluent (MERCK) lot # M034763, expiration date 22-APR-2019. The temperature excursion was of 6°F to 14°F, during 120 hours 30 minutes. However, a previous temperature excursion of 47°F to 50°F for 35 minutes was also reported. A digital data logger was involved. No adverse effects were reported. Additional information is not expected. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1712USA013991: US-009507513-1801USA003526: US-009507513-1801USA003527: US-009507513-1801USA003520: US-009507513-1801USA003521: US-009507513-1801USA003522: US-009507513-1801USA003523: US-009507513-1801USA003612: US-009507513-1801USA003524.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. The patient's historical drugs, medical history, concomitant therapies, drugs allergies and concurrent conditions were not reported. On 18-DEC-2017, the patient was vaccinated with an improperly stored dose of PROQUAD lot # N016994, expiration date 29-NOV-2018, for prophylaxis (strength, dose, route and frequency were not reported). The PROQUAD was reconstituted with a properly stored sterile diluent (MERCK STERILE DILUENT) lot # M034763, expiration date 22-APR-2019. The temperature excursion was of 6°F to 14°F, during 120 hours 30 minutes. However, a previous temperature excursion of 47 °F to 50°F for 35 minutes was also reported. A digital data logger was involved. No adverse effects were reported. Additional information is not expected. This is one of several reports received from  the same reporter.; Sender's Comments:  US-009507513-1801USA003525: US-009507513-1712USA013991: US-009507513-1801USA003527: US-009507513-1801USA003520: US-009507513-1801USA003524: US-009507513-1801USA003523: US-009507513-1801USA003522: US-009507513-1801USA003521: US-009507513-1801USA003612:
Age: 28.0
Sex: M
Vaccine: FLUC4
Symptoms: Dysphagia, Swollen tongue
Clinical narrative: Pt c/o swollen tongue, difficulty swallowing the following day.
Age: 75.0
Sex: M
Vaccine: FLU3
Symptoms: Pruritus, Urticaria
Clinical narrative: This is a single dose injection that the patient received and this is the first Flu Vaccine the patient ever received in his life. He awoke this morning with severe hives covering his upper arms and severe itching.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site cellulitis, Injection site erythema
Clinical narrative: Patient came into pharmacy on 1/11/18 reporting that she has cellulitis at the site of her ZOSTAVAX injection. She showed me the spot, and it's about 1 inch in diameter around the injection site. It is red in color and circular in appearance. She went to the doctor and is being treated for it with cephalexin 500 mg 1 by mouth twice a day for 10 days.
Age: 3.0
Sex: M
Vaccine: HEPA
Symptoms: Urticaria
Clinical narrative: Urticarial rash 1 day after Hepatitis A vaccine. No other exposures recalled.
Sex: M
Vaccine: FLUX, TDAP
Symptoms: Drug administered to patient of inappropriate age, Injection site pain, Paraesthesia
Clinical narrative: Initial unsolicited report received from a pharmacist on 16-Nov-2017. This case involves a 72-year-old male patient who was vaccinated with 0.5 ml dose of ADACEL via intramuscularly (batch number, expiry date, dose series were not reported) in the left deltoid on an unknown day of Oct-2016. The patient medical history were not reported. Concomitant medication included vaccination with a dose of FLU VACCINE via intramuscularly in the right deltoid on an unknown day of Oct-2016  On an unknown day, following the vaccination, the patient experienced severe pain, which felt like an electric shock going through the left shoulder area through neck to the right shoulder, the pain lasted almost one year and then started to subside. It was a case of actual medication error due to inappropriate age at vaccine administration Lab test and corrective treatment were not reported. The outcome radiating pain was not reported. 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.
Age: 76.0
Sex: M
Vaccine: FLU3
Symptoms: Extra dose administered, Mobility decreased, Pain in extremity
Clinical narrative: Initial unsolicited report received from a patient-himself on 17-Nov-2017. This case involves a 76-year-old male patient, who was vaccinated with a dose of FLUZONE HD intramuscularly once (Batch number: UI877AB, expiration date: 17-May-2018, dose, dose in series were not reported) in the arm on 17-Oct-2017 and again on 25-Oct-2017. The medical history and concomitant medication was not reported. On an unknown day, following the vaccination, the patient developed very painful in arm which extending from shoulder to elbow, unable to lift arm. It was a case of actual medication error due to extra dose administered. Lab investigation was not reported and corrective treatment was Ibuprofen/TYLENOL as needed. The outcome of mobility decreased and painful arm was recovering. 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 and Module 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. Documents held by sender: none.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injection site nerve damage, Muscular weakness, Pain, Pain in extremity
Clinical narrative: Patient received flu vaccine in right upper arm and immediately reports an "electric shock" sensation that traveled the length of her arm into the hand. Patient continued to experience throbbing pain in the upper arm/shoulder for the next month, although the electric shock sensation was only felt at the time of injection. In December, the patient went to her family doctor as symptoms continued and reports increasing weakness to the arm. Dr. reports that the nurse administering likely hit/irritated the axillary nerve during administration. He has ordered an EMG for the patient scheduled for 1/18/18.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Paraesthesia
Clinical narrative: Patient received flu vaccine in right upper arm and immediately reports an "electric shock" sensation that traveled the length of her arm into the hand. Patient continued to experience throbbing pain in the upper arm/shoulder for the next month, although the electric shock sensation was only felt at the time of injection. In December, the patient went to her family doctor as symptoms continued and reports increasing weakness to the arm. Dr. reports that the nurse administering likely hit/irritated the axillary nerve during administration. He has ordered an EMG for the patient scheduled for 1/18/18.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site erythema, Injection site swelling, Pain
Clinical narrative: Reported swelling and redness of right upper arm the evening after the shot given on 01/12/2018. Reported to pharmacy on 1/15/2018 for pharmacist to evaluate. Erythema reaction with pain, recommended tylenol and report any further progression or worsening of symptoms.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Body temperature increased, Neutrophil count decreased, Petechiae, Platelet count decreased, Rash generalised
Clinical narrative: Maculopapular rash started on 1/4/18. On 1/5 had temp 102 that lasted only for a few hours, no fever since. On 1/6 rash had spread to all over body and parents took to urgent care. Urgent Care did bloodwork and gave Dexamethasone sodium phosphate - 6mg. Platelets were low and ANC was low. Seen in office on 1/8 - still had rash and also had petechia. No other bleeding noted. Labs recheched on 1/12/18 and were improved. Currently mom states rash almost gone.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Rash maculo-papular
Clinical narrative: Maculopapular rash started on 1/4/18. On 1/5 had temp 102 that lasted only for a few hours, no fever since. On 1/6 rash had spread to all over body and parents took to urgent care. Urgent Care did bloodwork and gave Dexamethasone sodium phosphate - 6mg. Platelets were low and ANC was low. Seen in office on 1/8 - still had rash and also had petechia. No other bleeding noted. Labs recheched on 1/12/18 and were improved. Currently mom states rash almost gone.
Age: 61.0
Sex: M
Vaccine: FLUR4
Symptoms: Anaphylactic reaction, Dizziness, Dyspnoea, Immediate post-injection reaction
Clinical narrative: Employee reports he received flu shot and had an immediate anaphylactic reaction with shortness of breath, lightheadedness. Rapid response was contacted and administered epinephrine. Employee was transported to urgent care and received BENADRYL and IV SOLU-MEDROL. Employee was observed and discharged.
Age: 4.0
Sex: F
Vaccine: DTAPHEPBIP, FLU4, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Left thigh developed area of swelling, erythema, warmth, and induration at site of injection, 5 inches in diameter.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Feeling abnormal, Malaise, Urticaria
Clinical narrative: Malaise, hives. Pt stated went to ED. This was discovered when pt was in office today, MD ordered Tdap update and pt declined, " I was miserable for days and don't want another ever, hives lasted days."
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Drug administered at inappropriate site, Electromyogram, Electromyogram abnormal, Injected limb mobility decreased, Injection site injury
Clinical narrative: Day after flu shot my left arm was painful. I assumed it was just sore from the injection. The following day it was still painful so I went to our Occupational Health Clinic and reported it as I was familiar with SIRVA and felt it should be reported "just in case".  I saw Dr. and told her my suspicions. She gave me steroids and had me follow up in one week. I followed up in one week with a PA with no improvement. He was not familiar with SIRVA and dismissed me just telling me to follow up with my PCP. After a few weeks of no improvement I went to my PCP and told him of my SIRVA suspicion. He just listened, but did not order anything. I also told my Neurologist, she did nothing. Months passed and the pain and my ROM got worse. I eventually complained enough my PCP ordered an EMG. The EMG confirmed slight damage from wrong injection placement, but at that point no surgical intervention needed (according to EMG). Pain has continually gotten worse and ROM poor. I contacted PCP again asking for MRI and physical therapy. I have gone to PT twice with no improvement. MRI on 1/13/2018. Shortened version of result findings: "Subtle signal variation at the articular and bursal surfaces suggest fraying/partial tearing of the tendon structures are contiguous and continuous with the full-thickness tears".  At this time I have stopped PT and am awaiting an Orthopedic Surgeon consult.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Nuclear magnetic resonance imaging abnormal, Pain in extremity, Tendon rupture
Clinical narrative: Day after flu shot my left arm was painful. I assumed it was just sore from the injection. The following day it was still painful so I went to our Occupational Health Clinic and reported it as I was familiar with SIRVA and felt it should be reported "just in case".  I saw Dr. and told her my suspicions. She gave me steroids and had me follow up in one week. I followed up in one week with a PA with no improvement. He was not familiar with SIRVA and dismissed me just telling me to follow up with my PCP. After a few weeks of no improvement I went to my PCP and told him of my SIRVA suspicion. He just listened, but did not order anything. I also told my Neurologist, she did nothing. Months passed and the pain and my ROM got worse. I eventually complained enough my PCP ordered an EMG. The EMG confirmed slight damage from wrong injection placement, but at that point no surgical intervention needed (according to EMG). Pain has continually gotten worse and ROM poor. I contacted PCP again asking for MRI and physical therapy. I have gone to PT twice with no improvement. MRI on 1/13/2018. Shortened version of result findings: "Subtle signal variation at the articular and bursal surfaces suggest fraying/partial tearing of the tendon structures are contiguous and continuous with the full-thickness tears".  At this time I have stopped PT and am awaiting an Orthopedic Surgeon consult.
Age: 4.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Pt received flu vaccine on 1/11/18. On 1/12/18 pt (L) arm became red swollen warm to touch at the vaccine site (L) delt. Pt came in to office on 1/13/18 and given AUGMENTIN. Pt returned to office today for a flu appt. Pt s/sx have greatly improved.
Age: 1.0
Sex: M
Vaccine: FLU4, MMR, VARCEL
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site swelling
Clinical narrative: Patient had immediate swelling and redness of left thigh, no further systemic reaction noted.
Age: 0.17
Sex: M
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant therapies and past drug reactions/allergies were not reported. On an unknown date, the patient was vaccinated with a dose of hepatitis b vaccine (recombinant)(manufacturer unknown) (strength, dose, route, anatomical location, lot # and expiration date were not reported) for prophylaxis. The registered nurse reported that the hepatitis b vaccine (recombinant)(manufacturer unknown) was given too early, and asked what could be the next course of action. No adverse effects were reported. Follow up information has been received from the reporting registered nurse on 03-JAN-2017, referring to a 10 week old male patient. On 29-DEC-2017, the patient was vaccinated with the third dose of RECOMBIVAX HB lot number: N009802, expiration date: 19-DEC-2019, for prophylaxis. The nurse informed that the interval between second and third dose was less than recommended.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 09-JAN-2018, the patient was vaccinated with an expired dose of PROQUAD lot # M007960; expiry date 15-AUG-2017 (dose and route of administration were not provided). The PROQUAD was reconstituted with sterile diluent. No adverse effect was reported.
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Musculoskeletal disorder, Paraesthesia
Clinical narrative: Initial unsolicited report received from a health-care professional on 18-Oct-2017. This case involves 39-year-old female patient, who was vaccinated with 0.5 ml dose of FLUZONE QUADRIVALENT once lot number: UT5937KA (expiry date were unknown) via intramuscular route in the left deltoid on 20-Sep-2017. Patient medical history and concomitant medication were not reported. On an unknown date, after the vaccination, patient experienced tingling sensation in her fingers off/on and symptoms of limited ROM and use of the left arm. Lab data and corrective treatment were not reported. Event outcome was unknown at the time of reporting. List of documents held by sender: none. Follow up report received from a health-care professional on 02-Jan-2018. No new information's received. List of documents held by sender: none.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site scab, Injection site swelling, Injection site vesicles
Clinical narrative: Initial unsolicited report received from a pharmacist on 20-Oct-2017. This case involves a 80-year-old female patient, who was vaccinated once with 0.5 ml injection of FLUZONE HIGH-DOSE via intramuscular route (batch number, expiry date, dose in series not reported) in left deltoid on 07-Oct-2017. Patient's medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient's left deltoid (injection site) had a raised red area and in the center of that area was a knob like raised area. Lab test and corrective treatment was not reported. Patient did not recover from the events. Follow-up report received from a pharmacist on 02-Jan-2018. Batch number of FLUZONE HIGH-DOSE was reported as UI836AA and expiry date was 02-Apr-2018. Patient received first dose of FLUZONE HIGH-DOSE. Patient's medical history included AFib, hypertension and hypercholesterolemia. Concomitant medications included Losartan, Warfarin, Statin and OTC Multivitamins daily. On an unknown date, following the vaccination, the patient had spot on arm had become "puffier" and more "like a blister" for which the patient consulted with PCP and was referred to a dermatologist. The dermatologist burned the area off on 28-Nov-2017. The dermatologist did not do any additional testing on the site and will not have follow-up to the patient unless the lump comes back. At the time of reporting, the area was flat and red after had been scabbed over from being burned off. No other additional laboratory tests were performed. Events outcome for all the events were recovering at the time of reporting. Documents held by sender: none.
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Local reaction
Clinical narrative: Initial unsolicited report received from pharmacist on 01-Nov-2017. This case was linked to 2017SA216202 (same reporter). This case involves female patient (age not reported) who was vaccinated with 0.5 ml once dose of FLUZONE HIGH-DOSE (Batch number: UI808AB, expiration date, dose, and site of administration was not reported) via intramuscular route on 30 Sep 2017. The patient's medical history and concomitant medications were not reported. On an unspecified date, following the vaccination, the patient developed large local reaction at injection site with redness and swelling to 5-inch size and then followed up with doctors. Lab data and corrective treatment were not reported. On an unspecified date, the patient was recovered from events. List of documents held by sender: none.
Sex: F
Vaccine: TD
Symptoms: Allergy to vaccine
Clinical narrative: Initial unsolicited report received from a consumer or non-healthcare professional via other company (Pfizer) (Manufacturer Report Number: 2017528310) on 02-Jan-2018. This case involves a female patient (onset age not reported) who was vaccinated with a dose of DIPHTHERIA AND TETANUS TOXOIDS (TETANUS DIPHTHERIA) (batch number, expiration date, dose, dose in series, route and site of administration were not reported) on an unspecified date. Patient's medical history and concomitant medications were not reported. On an unspecified date, following vaccination the patient was allergic to the vaccine. Laboratory investigations and corrective treatment were not reported. The outcome of the event was not reported. List of documents held by sender: none.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Arm pain at and around injection site.
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Musculoskeletal pain, Pain, X-ray limb normal
Clinical narrative: Patient was seen in our office on 1/10/2017 complained of severe left shoulder pain (rating 8 out of 10) with "certain movements," states started after she received the flu vaccine one month ago. Pt stated that the day after she received the shot, she had the normal soreness associated with the vaccine but the next day, there was pain that has not gone away with no redness or swelling present. Denies injury. Denies fever. Denies pain to any other joints. Denies left shoulder pain at this time. Left shoulder X-rays was ordered for patient.
Age: 22.0
Sex: F
Vaccine: HEP
Symptoms: Erythema, Pruritus
Clinical narrative: Pruritus on the left forearm and the right wrist along with redness.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Feeling cold, Nausea, Pain in extremity
Clinical narrative: Patient reported extreme pain in his left arm - similar to when he had rotator cuff surgery. He was nauseous and incredibly cold (was in bed under the covers with his heavy coat on). His symptoms lasted for approximately 24 hours.
Age: 0.92
Sex: F
Vaccine: HIBV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Reviewing charts for tomorrow, realized that on 11/13/17 I had given Hib and PENTACEL to patient, giving her an extra dose of Hib. Patient had no known ill effects from additional dose.
Age: 0.08
Sex: F
Vaccine: DTAP
Symptoms: Allergy to vaccine, Cyanosis, Dyspnoea, Listless, Peripheral coldness
Clinical narrative: After the vaccination the baby felt feverish and listless. Later in the evening of the vaccination, the baby started shaking violently, turned blue, and appeared to have trouble breathing. By the time rescue got there, the baby had started breathing, but was still blue and very cold. I was asked what had happened to the baby that day, and told them it was the day she got her first dose of the vaccination DTaP. When I took her to the health department the next time, and explained what had happened, I was told she is allergic to Pertussis. I didn't know I could report this until today, 28 years after the incident. She's since, never had any Pertussis.
Age: 0.08
Sex: F
Vaccine: DTAP
Symptoms: Pyrexia, Tremor
Clinical narrative: After the vaccination the baby felt feverish and listless. Later in the evening of the vaccination, the baby started shaking violently, turned blue, and appeared to have trouble breathing. By the time rescue got there, the baby had started breathing, but was still blue and very cold. I was asked what had happened to the baby that day, and told them it was the day she got her first dose of the vaccination DTaP. When I took her to the health department the next time, and explained what had happened, I was told she is allergic to Pertussis. I didn't know I could report this until today, 28 years after the incident. She's since, never had any Pertussis.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Computerised tomogram normal, Headache, Nuclear magnetic resonance imaging normal
Clinical narrative: Persistent headache that had lasted for over two weeks by the time she came to reporter's office.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Extra dose administered
Clinical narrative: Pt was accidentally given 2 doses of PROQUAD - was supposed to get 1 proquad and 1 kinrix - once MA realized the mistake, notified doctor  - poison control was called to make sure no side effects = parents notified.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Extra dose administered
Clinical narrative: Pt accidentally received 2 KINRIX vaccines - was supposed to get 1 KINRIX and 1 PROQUAD - once the MA realized his mistake the Dr was notified, poison control was called to make sure no side effects - parents notified.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: Patient received injection and then approximately one day later developed a fever with aches. Called to report to pharmacy. Largely resolved after an additional day.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Facial paralysis
Clinical narrative: Bell's palsy.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Body aches, fever & chills for 30 hours.
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site pain, Injection site reaction, Muscle spasms, Pain
Clinical narrative: Since my visit in November I have experienced cramping, pain, and limited ROM at the site of my flu shot in the left lower deltoid. I have noticed it but became extremely apparent during a relaxation massage on 01/03/2018. I wrote my healthcare provider to let her know my concern and she instructed me to report it to the CDC. I have no redness but with activity or abduction have limited ROM, pain, and cramping. I use ice, heat, massage, and stretch to treat.
Age: 70.0
Sex: M
Vaccine: PNC13
Symptoms: Eczema
Clinical narrative: Mild, eczematoid rash of biceps region, just medial and distal to injection site.
Sex: U
Vaccine: HEP, HEPA, HPV9, MMR, RV5, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a Registered Nurse and refers to an unspecified amount of unspecified patients of an unknown age and gender. Patients' medical history, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with an unspecified number of improperly stored doses of ROTATEQ orally, VAQTA, RECOMBIVAX HB, GARDASIL 9, VARIVAX and M-M-R II  (doses, routes of administration, anatomical locations, lot numbers and expiration dates were not reported for any vaccine) for prophylaxis. The administered dose of the vaccines experienced an unknown temperature excursion for an unknown period of time, it was called by a data logger. There was a previous temperature excursion; however the details were unknown. The sterile diluent was stored properly. No adverse effects were reported.
Sex: F
Vaccine: TTOX
Symptoms: Loss of personal independence in daily activities, Musculoskeletal pain
Clinical narrative: Initial unsolicited literature report received from a physician on 04-Jan-2018. Literature reference:  This case involves a female patient of unknown age who was vaccinated with a dose of TETANUS TOXOID (TETANUS SHOT) (Lot number, expiry date, route and site of administration were not reported) on an unknown date. The patient's medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient experienced stabbing pain in left shoulder that worsened in days after her tetanus shot and felt like the arm was falling off. She couldn't carry her purse or hold a cup of coffee. She couldn't lift that arm above her head or place it on the steering wheel of her car. The patient's laboratory data and corrective treatment were not reported. The event's outcome was unknown. List of documents held by sender: none.
Age: 40.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain
Clinical narrative: Stated pain at the injection site and after visited a doctor at the walk in clinic.
Sex: U
Vaccine: FLUX
Symptoms: Dyspnoea, Urticaria
Clinical narrative: Initial unsolicited report received from Physician on 04-Jan-2018. This case involves a patient of unknown age and gender, who was vaccinated with a dose of INFLUENZA VACCINE (batch number, expiry date, dose, dose in series, route and site of administration were not reported) on an unknown date (reported as one year ago). Patient medical history and concomitant medications were not reported. On unknown date, following the vaccination the patient experienced hives and shortness of breath. Lab data and corrective treatment were not reported. On an unknown date, patient recovered from both events. List of documents held by sender: none.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Rash
Clinical narrative: Patient called about mild rash on cheeks and neck later that day. Advised to go to urgent care if worsened, recommended BENADRYL and hydrocortisone cream (rash was not itchy at the time). Called patient next day, and rash did not worsen.
Age: 79.0
Sex: F
Vaccine: FLUA3, FLUA3
Symptoms: Musculoskeletal pain
Clinical narrative: She stated that her shoulder hurt for a couple weeks and that she believes that the immunization was shot too high. She mentioned this to her doctor when she had an unrelated appointment and they stated that the shot may have hit her tendon and given her a mild case of tendonitis.
Age: 31.0
Sex: M
Vaccine: TDAP
Symptoms: Erythema, Skin warm, Tenderness
Clinical narrative: Patient's arm is red, warm, swollen and tender. The warmth is diminished but is still red and tender.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Erythema and swelling measuring 5 x 6 cm, hot to touch. PCP ordered KEFLEX for possible cellulitis.
Age: 19.0
Sex: M
Vaccine: HEPA
Symptoms: Unevaluable event
Clinical narrative: No adverse events or outcomes reported by patient currently.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash pruritic, Vaccination complication, Vaccination site rash
Clinical narrative: Patient had reaction to vaccine and experienced a rash on her left arm where vaccine was injected. Patient also stated that the rash was itchy for about 10 days.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, DTAPIPVHIB, PNC13, RV5
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Given PEDIARIX, PENTACEL, PCV13, and ROTATEQ no adverse effects.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Diarrhoea, Eye discharge, Eye irritation
Clinical narrative: Patient had stated that he got a reaction the first time he received the vaccine, but the MD recommended he get it again. After the vaccine, he came back a few hours later to the pharmacy and stated he had the same side effects as the first time he got it 5 years ago. The adverse events were as follows: burning in the eyes, diarrhea, and yellowy thick discharge coming out of the corners of his eye. I told him to proceed with some OTC treatments and if anything worsened to contact his MD.
Age: 81.0
Sex: M
Vaccine: PPV
Symptoms: Fatigue, Pyrexia
Clinical narrative: Patient said he was running fever and felt fatigued for 2 days, no other symptoms.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Feeling abnormal, Immediate post-injection reaction, Mobility decreased, Pain in extremity
Clinical narrative: Immediately upon getting the vaccine it felt like someone was pouring water inside my arm. From that time on the arm was very sore, making it difficult to raise my arm above my head. I am taking ADVIL every day and also using heat and cold on the arm. The symptoms have lessened, but are still not completely gone. I did contact my primary care physician who offered to do tests to determine what damage had been done. Since I knew it is from the flu shot, I declined testing.
Age: 16.0
Sex: F
Vaccine: FLU4, HPVX
Symptoms: Wrong drug administered
Clinical narrative: Patient was in the office and agreed to have Flu shot and Meningococcal. When preparing the vaccines, HPV was drawn and administered instead of Meningococcal. After realizing the error, the provider and lead staff were advised. Patient's father was advised of error. He was advised she may have pain around injection site, like any other vaccine but shouldn't have any side effects. He verbalized understanding. Also advised that she can come into the office to get correct vaccine in 30 days.
Age: 6.0
Sex: F
Vaccine: FLU4
Symptoms: Extra dose administered
Clinical narrative: Patient was brought in by father for 6yrs physical. The nurse practitioner talked and examined the patient and found this patient did not have any Influenza vaccine documented in her state immunization card and advised father to let us give her the influenza vaccine. Father then called mother, then said yes. Vaccine was given uneventfully. But mother called back and told us the patient had her first dose of Influenza vaccine here, but just did not brought the card and not been documented. She gave the IMM card to father and father gave the IMM card to our front desk staff. I found the back office nurse did not update the IMM card and led the error. I deeply apologized to mother and told her if patient has any symptoms, come back or go to local ER and I also will report the error to the county. I called CDC and spoke to Dr., I called and report to state and our Health Department.
Age: 9.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth, Local reaction
Clinical narrative: L deltoid became very swollen/red/hard hot from shoulder down to the elbow. Onset was a little before 7 pm; painful referred by oncall physician to urgent care. Confirmed local reaction and prescribed steroid cream.
Age: 9.0
Sex: F
Vaccine: FLU4
Symptoms: Pain
Clinical narrative: L deltoid became very swollen/red/hard hot from shoulder down to the elbow. Onset was a little before 7 pm; painful referred by oncall physician to urgent care. Confirmed local reaction and prescribed steroid cream.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Rash generalised
Clinical narrative: Patient states she is unable to recall when symptoms started. She states she has a rash over face and body. Per patient, rash is not red or inflamed. She has no other symptoms and feels well at this time. She states she has had this rash before and is unsure if it is directly related to vaccine that was given as she has other allergies that have caused the same reaction.
Age: 3.0
Sex: M
Vaccine: FLU4
Symptoms: Chills, Fatigue, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Fever, vomiting, chills, fatigue the night after receiving vaccine. Swollen/red/hot leg on Friday.
Age: 3.0
Sex: M
Vaccine: FLU4
Symptoms: Pyrexia, Vomiting
Clinical narrative: Fever, vomiting, chills, fatigue the night after receiving vaccine. Swollen/red/hot leg on Friday.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Rash
Clinical narrative: Patient developed a rash on arm that spread that evening of vaccine.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site vesicles
Clinical narrative: Patient stated that she had marginal amount of redness and swelling at the injection site. She also had two blisters at the injection site.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Parosmia
Clinical narrative: This spontaneous report as received from a registered nurse, refers to 67 a non pregnant year-old female patient. Information on concomitant medications and pertinent medical history were unknown by the reporter. Patient's drug reactions and allergies included atorvastatin, gabapentin, canagliflozin (INVOKANA), sitagliptin phosphate (JANUVIA)(case # 1712USA13824), metformin, pioglitazone, rosuvastatin, empagliflozin+metformin hydrochloride (SYNJARDY) and verapamil. On 14-DEC-2017, the patient was vaccinated with a dose of PNEUMOVAX 23 lot number N019838, expiration date 16-FEB-2019 (dose number, route and strenght were not provided) for prophylaxis. On the same date, 3 hours after receiving the dose, the patient experienced a smelling sensation described as " burning plastic and burning rubber". The reporting nurse stated that the patient also had redness and swelling at the injection site. The patient did not seek medical attention and no treatment was given for the adverse events. It was unknown by the reporter if laboratories were performed. The outcome of the smelling sensation was reported as not recovered, whereas the patient's redness and swelling of the site injection were noted as recovered. The registered nurse did not assess a causal relationship between the adverse events and PNEUMOVAX 23. This is one of two reports received from the same reporter.; Sender's Comments: US-009507513-1712USA013824: