chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site induration, Injection site pain, Musculoskeletal stiffness, Neck pain, Wrong technique in product usage process
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of injection site pain in a female patient who received SHINGRIX for prophylaxis. The patient's past medical history included shoulder replacement. Previously administered products included Tylenol and Aleve. On 28th February 2019, the patient received the 2nd dose of SHINGRIX. On 28th February 2019, 5 hrs after receiving SHINGRIX, the patient experienced injection site pain, injection site induration, neck pain, stiff neck, headache, dizziness, weakness and feeling anxious. On an unknown date, the patient experienced wrong injection technique. On an unknown date, the outcome of the injection site pain, injection site induration, neck pain, stiff neck, headache, dizziness, weakness, feeling anxious and wrong injection technique were unknown. It was unknown if the reporter considered the injection site pain, injection site induration, neck pain, stiff neck, headache, dizziness, weakness and feeling anxious to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The caller who was a retired registered nurse reported that the patient received SHINGRIX on left deltoid arm around 1pm. The patient began to had symptoms at around 6 pm that evening consisting of pain at injection site, hardness at injection site the size of a fity cent piece, pain radiating up the left side of her neck with stiffness, headache, dizziness, weakness, felt off center and anxious, dizzy. The patient was taken Tylenol and Aleve for her right shoulder replacement she recently had done and feels the medication may have masked even more symptoms. The patient biggest concern was the vaccine was given with a subcutaneous needle instead of an intramuscular needle, which led to wrong injection technique. The patient also concerned about the efficacy of the second vaccine. She had her second dose at the pharmacy that was listed below. She was also concerned that the same pharmacist was given the vaccine to many others with the incorrect needle. She did contact another pharmacist there and told him what had occurred. She was seeing her surgeon today for a post-op visit for her shoulder replacement and will have him look at her injection site. This case has been linked to US2019GSK046595, reported by the same reporter.
Age: 66.0
Sex: F
Vaccine: FLU4, VARZOS, VARZOS
Symptoms: Headache, Pyrexia, Sensory disturbance
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of headache in a 66-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2018-2019 season) for prophylaxis. On 1st October 2018, the patient received the 1st dose of SHINGRIX and Influenza vaccine Quadrivalent 2018-2019 season. On an unknown date, less than a year after receiving SHINGRIX and Influenza vaccine Quadrivalent 2018-2019 season, the patient experienced headache, fever and abnormal physical sensation. On an unknown date, the outcome of the headache, fever and abnormal physical sensation were recovered/resolved. It was unknown if the reporter considered the headache, fever and abnormal physical sensation to be related to SHINGRIX and Influenza vaccine Quadrivalent 2018-2019 season. Additional details were reported as follows: The patient received SHINGRIX vaccine on an unknown deltoid. In October 2018, The patient received a flu shot at the same time as her dose of SHINGRIX and experienced headache, fever and a mild mouth sensation that lasted for 12 hours. For tolerance of 2nd dose of SHINGRIX, refer case US2019GSK045374. The patient had an appointment with a throat specialist on the day of reporting. The reporter consented to follow up.
Age: 66.0
Sex: F
Vaccine: FLU4, VARZOS, VARZOS
Symptoms: Aphonia, Asthenia, Burning mouth syndrome, Chills, Fatigue
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of headache in a 66-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2018-2019 season) for prophylaxis. On 1st October 2018, the patient received the 1st dose of SHINGRIX and Influenza vaccine Quadrivalent 2018-2019 season. On an unknown date, less than a year after receiving SHINGRIX and Influenza vaccine Quadrivalent 2018-2019 season, the patient experienced headache, fever and abnormal physical sensation. On an unknown date, the outcome of the headache, fever and abnormal physical sensation were recovered/resolved. It was unknown if the reporter considered the headache, fever and abnormal physical sensation to be related to SHINGRIX and Influenza vaccine Quadrivalent 2018-2019 season. Additional details were reported as follows: The patient received SHINGRIX vaccine on an unknown deltoid. In October 2018, The patient received a flu shot at the same time as her dose of SHINGRIX and experienced headache, fever and a mild mouth sensation that lasted for 12 hours. For tolerance of 2nd dose of SHINGRIX, refer case US2019GSK045374. The patient had an appointment with a throat specialist on the day of reporting. The reporter consented to follow up.
Age: 66.0
Sex: F
Vaccine: FLU4, VARZOS, VARZOS
Symptoms: Headache, Lip disorder, Oral herpes, Pallor, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of headache in a 66-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2018-2019 season) for prophylaxis. On 1st October 2018, the patient received the 1st dose of SHINGRIX and Influenza vaccine Quadrivalent 2018-2019 season. On an unknown date, less than a year after receiving SHINGRIX and Influenza vaccine Quadrivalent 2018-2019 season, the patient experienced headache, fever and abnormal physical sensation. On an unknown date, the outcome of the headache, fever and abnormal physical sensation were recovered/resolved. It was unknown if the reporter considered the headache, fever and abnormal physical sensation to be related to SHINGRIX and Influenza vaccine Quadrivalent 2018-2019 season. Additional details were reported as follows: The patient received SHINGRIX vaccine on an unknown deltoid. In October 2018, The patient received a flu shot at the same time as her dose of SHINGRIX and experienced headache, fever and a mild mouth sensation that lasted for 12 hours. For tolerance of 2nd dose of SHINGRIX, refer case US2019GSK045374. The patient had an appointment with a throat specialist on the day of reporting. The reporter consented to follow up.
Age: 66.0
Sex: F
Vaccine: FLU4, VARZOS, VARZOS
Symptoms: Sensory disturbance, Tongue disorder
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of headache in a 66-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2018-2019 season) for prophylaxis. On 1st October 2018, the patient received the 1st dose of SHINGRIX and Influenza vaccine Quadrivalent 2018-2019 season. On an unknown date, less than a year after receiving SHINGRIX and Influenza vaccine Quadrivalent 2018-2019 season, the patient experienced headache, fever and abnormal physical sensation. On an unknown date, the outcome of the headache, fever and abnormal physical sensation were recovered/resolved. It was unknown if the reporter considered the headache, fever and abnormal physical sensation to be related to SHINGRIX and Influenza vaccine Quadrivalent 2018-2019 season. Additional details were reported as follows: The patient received SHINGRIX vaccine on an unknown deltoid. In October 2018, The patient received a flu shot at the same time as her dose of SHINGRIX and experienced headache, fever and a mild mouth sensation that lasted for 12 hours. For tolerance of 2nd dose of SHINGRIX, refer case US2019GSK045374. The patient had an appointment with a throat specialist on the day of reporting. The reporter consented to follow up.
Sex: M
Vaccine: DTAP, PNC13
Symptoms: Ill-defined disorder
Clinical narrative: Initial information received on 01-Mar-2019 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a male patient who experienced illness, while he received vaccine DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE and while treated with PREVENAR 13. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient started taking PREVENAR 13 dosage unknown (with an unknown batch number) for Immunisation. On an unknown date, the patient received a dose of suspect DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site. On an unknown date, the patient developed a non-serious illness (ill-defined disorder) (unknown latency) following the intake of PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) and DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE. (Other relevant tests included NO lab data). Final diagnosis was illness. It was not reported if the patient received a corrective treatment. The patient outcome was not reported. List of document held by sender: none.
Age: 1.33
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Rash generalised
Clinical narrative: MOM REPORTED PATIENT WOKE UP ON 02/28/2019 WITH A RASH ON HER BODY (FACE, LEGS, ARMS, BACK, STOMACH). MOM REPORTED THIS HAS NEVER HAPPENED TO HER BEFORE AND SHE HAD NOT EATEN, DRANK, OR BEEN AROUND ANYTHING NEW. I REFERRED PATIENT TO HER DOCTOR. MOM STATED SHE WOULD TAKE HER IN TO HER DOCTOR SAME DAY.
Age: 60.0
Sex: M
Vaccine: FLU4, MMR
Symptoms: Arthralgia, Joint swelling, Peripheral swelling
Clinical narrative: Diffuse joint pain and swelling involving the knees, ankles and toes of both legs/feet that started two days following the vaccinations. Symptoms resolved slowly over a period of two weeks.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: Patient states he felt very sick after 1st dose. VAERS requested by doctor.
Age: 36.0
Sex: M
Vaccine: JEV1, TYP
Symptoms: Impaired work ability, Rash, Urticaria
Clinical narrative: Patient reported having hives/rash that started on neck and face 4 days following vaccination on 2/23/2019. Went to urgent care on February 26 2019 and was prescribed Prednisone which he took for 5 days. He missed 2 days of work on February 26 & 27. Patient also received an allergy shot 2 days after receiving the 2 vaccines. He had 5 prior allergy shots of the same dose without any sign of a systemic reaction. He received the first series of both vaccines in 2001. He does not recall having any adverse reaction after receiving the first series.
Age: 0.08
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Erythema, Lip swelling, Peripheral swelling, Swelling face
Clinical narrative: Swelling  and erythema hands bilaterally. Swelling of feet right upper cheek/lip.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Patient returns to the walk-in clinic with complaint of right arm pain.
Age: 14.0
Sex: M
Vaccine: HPVX
Symptoms: Product storage error
Clinical narrative: Information has been received from a physician via Pfizer and Merck Biopharma, referring to a 15 years old male patient. No information was provided regarding the patient's medical history, concurrent conditions, concomitant medications or drug reactions/allergies. On 28-JUN-2018, the patient was vaccinated with a an improperly stored unidentified Merck Human papilloma virus (HPV) vaccine (name, strength, dose, dose number, anatomical injection site, route of administration, lot number and expiration date were not reported) for prophylaxis.; Sender's Comments: US-MMM-WNDKC0ES:
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Injection site pain, Pruritus, Skin exfoliation
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 75-year-old male patient who received SHINGRIX for prophylaxis. On 24th January 2019, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than a month after receiving SHINGRIX, the patient experienced injection site pain, erythema, pruritus and flaking skin. The patient was treated with desonide. On an unknown date, the outcome of the injection site pain, erythema, pruritus and flaking skin were unknown. It was unknown if the reporter considered the injection site pain, erythema, pruritus and flaking skin to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX and experienced injection site soreness which lasted for 2 days. About 24 hours later he developed redness like sunburn right across his brow on the forehead 2 inches below the hairline associated with skin flaking and itching. The patient went to a dermatologist recently due to this and he was prescribed Desonide cream 0.05%. Did not consent to follow up. No further details were provided. Referred to health care professional.
Sex: F
Vaccine: FLUX
Symptoms: Adverse reaction
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of adverse reaction in a female patient who received Flu unspecified (Flu vaccine) for prophylaxis. On an unknown date, the patient received Flu vaccine at an unknown dose. On an unknown date, unknown after receiving Flu vaccine, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown. It was unknown if the reporter considered the adverse reaction to be related to Flu vaccine. Additional details were provided as follows: The age at vaccination was not reported. The practice supervisor mentioned the patient had a reaction to a flu vaccine. The GSK agent said reporter had mentioned a flu vaccine reaction to her. She attempted to transfer call to GSK medical investigator. The call was disconnected. The patient reached out to speak with reporter via telephone number provided and was given an alternate number and connected with that number. The patient was unable to speak with her at time of initial report. The patient provided a case number to her voice mail.
Sex: F
Vaccine: HEP
Symptoms: Antibody test negative, Therapy non-responder
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of therapy non-responder in a 20-year-old female patient who received ENGERIX B for prophylaxis. Co-suspect products included ENGERIX B for prophylaxis and ENGERIX B for prophylaxis. On an unknown date, the patient received the 1st dose of ENGERIX B, the 2nd dose of ENGERIX B and the 3rd dose of ENGERIX B. On an unknown date, unknown after receiving ENGERIX B, ENGERIX B and ENGERIX B, the patient experienced therapy non-responder. On an unknown date, the outcome of the therapy non-responder was unknown. It was unknown if the reporter considered the therapy non-responder to be related to ENGERIX B, ENGERIX B and ENGERIX B. Additional details were reported as follows: The age at vaccination was not reported. Nurse noted the patient received the full 3 dose of series of ENGERIX -B and as per titers patient did not develop immunity. Nurse noted on 4th March 2019, the patient was given a 4th dose of ENGERIX -B (batch number 4795H, expiry date 14th July 2020). Lab Comments: lab test were performed on an unknown date.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Ear pain, Headache, Influenza like illness, Insomnia, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a 61-year-old male patient who received SHINGRIX for prophylaxis. On 1st March 2019, the patient received the 1st dose of SHINGRIX. On 1st March 2019, less than a day after receiving SHINGRIX, the patient experienced fever, general body pain, headache, sleeplessness, pain in arm, ear pain and influenza-like symptoms. The patient was treated with naproxen (Aleve). On an unknown date, the outcome of the fever, general body pain, headache, sleeplessness, pain in arm, ear pain and influenza-like symptoms were recovering/resolving. It was unknown if the reporter considered the fever, general body pain, headache, sleeplessness, pain in arm, ear pain and influenza-like symptoms to be related to SHRINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left arm. The patient reported by evening he was experiencing the following symptoms, fever, body aches, headaches, unable to sleep, sore left arm, sore left ear. The patient was taking Aleve for pain management. The patient reported some improvements in these symptoms since day of vaccination. The patient said on the day of reporting, he felt like getting over the flu. The reporter gave consent to follow up.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a 61-year-old male patient who received SHINGRIX for prophylaxis. On 1st March 2019, the patient received the 1st dose of SHINGRIX. On 1st March 2019, less than a day after receiving SHINGRIX, the patient experienced fever, general body pain, headache, sleeplessness, pain in arm, ear pain and influenza-like symptoms. The patient was treated with naproxen (Aleve). On an unknown date, the outcome of the fever, general body pain, headache, sleeplessness, pain in arm, ear pain and influenza-like symptoms were recovering/resolving. It was unknown if the reporter considered the fever, general body pain, headache, sleeplessness, pain in arm, ear pain and influenza-like symptoms to be related to SHRINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left arm. The patient reported by evening he was experiencing the following symptoms, fever, body aches, headaches, unable to sleep, sore left arm, sore left ear. The patient was taking Aleve for pain management. The patient reported some improvements in these symptoms since day of vaccination. The patient said on the day of reporting, he felt like getting over the flu. The reporter gave consent to follow up.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Soreness at injection site/general shoulder pain.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Rash, Rash erythematous, Rash vesicular
Clinical narrative: DESCRIBED RED BLISTERY RASH ON STOMACH, SMALL BLISTERS ON ARMS AND LEGS. LASTED ABOUT A WEEK. STATED TOOK B-COMPLEX TO HELP CURE IT.
Age: 0.33
Sex: M
Vaccine: DTAP, HIBV, MNQ, PNC13, RV5
Symptoms: No adverse event, Product packaging confusion, Wrong product administered
Clinical narrative: The nurse had intentions of administering IPV (polio). She accidently administered MENACTRA.  After investigating possible causes, MENACTRA was found sitting in front of the polio vaccine in the refrigerator. These vaccines have similar looking boxes and labels. Although the provider confirmed that this vaccine was safe for his age, the facility chose to report this incident due to an error in administration. The patient tolerated the vaccine without reported adverse effects. No further action was determined to be needed. He will receive his IPV Inactivated Poliovirus vaccine at his next well child visit at 6 months. This will be in the time frame for the vaccine. The caregiver was notified of this error and voices understanding.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Local reaction, Mobility decreased, Rash erythematous
Clinical narrative: HALF DOLLAR SIZE LOCAL RAISED RED AREA WITH BUMPS, DID NOT BLISTER NO FEVER NOTICED, VERY ACHEY JOINTS COULD NOT MOVE OR FUNCTION FOR 2 & 1/2 DAYS WAS IN BED MOST OF THE TIME, NO CHILLS OR NASEA OR VOMITING JUST SEVERE JOINT PAIN. PAIN AND LOCAL REACTION GONE WITH-IN 96 HOURS OF FIRST OCCURING. TOOK TYLENOL FOR PAIN.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Myalgia, Nausea
Clinical narrative: Severe headache, severe nausea, teeth chattering, whole body muscle aches.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Paraesthesia
Clinical narrative: Patient states: Chills began 16 hours post vaccination, lasting for a couple hours. Then a sensation of pins and needles all over her body, one area at a time lasting for at least two hours. Pt took tylenol.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Acne, Blister, Erythema, Herpes zoster, Rash
Clinical narrative: 3 days after receiving SHINGRIX, the patient developed a rash on his left forehead "cluster of vesicles", dx'ed with possible shingles and rx'ed valacyclovir. The rash spread, as well as developed white heads. The left side of his face was swollen. Advised to see dermatology to r/u bacterial cellulitis vs shingles. Dermatologist saw the patient 6 days post-vaccine. Dx'ed with Herpes Zoster, rx'ed triamcinolone cream as well as the valacyclovir that was already rx'ed. Rash cleared within a few weeks. Patient had some mild residual tenderness and redness as the skin healed.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Swelling face, Tenderness
Clinical narrative: 3 days after receiving SHINGRIX, the patient developed a rash on his left forehead "cluster of vesicles", dx'ed with possible shingles and rx'ed valacyclovir. The rash spread, as well as developed white heads. The left side of his face was swollen. Advised to see dermatology to r/u bacterial cellulitis vs shingles. Dermatologist saw the patient 6 days post-vaccine. Dx'ed with Herpes Zoster, rx'ed triamcinolone cream as well as the valacyclovir that was already rx'ed. Rash cleared within a few weeks. Patient had some mild residual tenderness and redness as the skin healed.
Sex: U
Vaccine: VARCEL
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. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX 1 dose, subcutaneously in the right arm, lot # R002057, expiration date 22-JAN-2020. There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit (7.9 degrees Fahrenheit) for 45 minutes and the temperature excursion of 15 degrees Fahrenheit to 46 degrees Fahrenheit (17.5 degrees Fahrenheit) for 13 hours. Data logger was involved. There were no previous excursions reported.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX by a healthcare provider for the long-prevention of shingles and zoster-related conditions. On an unknown date in 2011, at approximately 60 years of age, the patient was administered the ZOSTAVAX by a healthcare provider (lot number, dosage and route of administration not provided). On an unknown date, the patient was treated by a healthcare provider for the following injury resulting from her ZOSTAVAX use: Shingles. The patient claimed damages as a result of: injury to herself, loss of consortium, loss of services, and economic losses. The outcome of the shingles is unknown. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. In April 2017, at age 66, the patient was administered the ZOSTAVAX vaccine by a pharmacist at a pharmacy (lot number, dosage and route of administration not provided). On an unknown date, the patient was treated at a hospital for the following injury resulting from her ZOSTAVAX use: Shingles. The patient claimed damages as a result of: injury to herself and economic losses. The outcome of the shingles is unknown. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster, Vaccination failure
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a male patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient had shingles. His primary care provider administered SHINGRIX before his symptoms had gone away. Naturally the SHINGRIX reactivated his shingles, and with a vengeance. On 08th March 2019 (on next day of reporting), the patient entering the 13th week with shingles. The patient wanted to know whether the vaccination he received was good because it was administered at the wrong time, or should he get the first vaccination over again once his shingles are totally gone. The patient requested to answer by email, so that he could print it out to present to his primary care provider. The agency did not seem to have a lot of knowledge about SHINGRIX. This case was considered as suspected vaccination failure as vaccine schedule, time to onset and laboratory confirmation were unknown at the time of reporting.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Exposure via skin contact, Syringe issue
Clinical narrative: Initial information received on 11-Mar-2019 regarding an unsolicited non-valid non-serious case received from a consumer/non-hcp. This case involves a patient who reported exposure via skin contact on 07-Mar-2019 when the needle was withdrawn and all the medication came spewing out of the vial and onto the HCP's skin, while reconstitution of the ActHIB vial with the Diluent form vaccine PENTACEL (lot C5409AA, expiry date 10-Oct-2019) and it was difficult to do with air bubble not coming out and the whole dose was depleted. Stopper was still in tact but the vaccine came out through the stopper. Diluent Lot C5551A, expiry date 10-Oct-2019, ActHIB Vial Lot C5409AA, expiry date 10-Oct-2019. This was a case of syringe issue and exposure via skin contact. No other information was reported.
Age: 14.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Emotional distress, Fall, Head injury, Headache, Swelling
Clinical narrative: About 10 min after HPV was given, staff heard a yell for help. Patient was lying on the floor holding her head. Mom said she turned around for a min, then as she turned, child fell from the table. Seemed to hit her body first then head on the floor. Patient was examined by Dr. Ice was applied to her head. She has a small lump on the left side of forehead and swollen bridge of her nose. She states she has a headache. No nausea or dizziness. She does not remember falling. Dr. wanted to get her on the table and keep her for a while. Patient was upset and wanted to go home. She stayed for about 15 min more while sitting on the floor. We got her up, Dr. walked her to check out, and asked if she needed help to the car. Mom said "No, I've got her." Patient is being seen again today on 3/14/19 for a follow up.
Age: 14.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Swelling face
Clinical narrative: About 10 min after HPV was given, staff heard a yell for help. Patient was lying on the floor holding her head. Mom said she turned around for a min, then as she turned, child fell from the table. Seemed to hit her body first then head on the floor. Patient was examined by Dr. Ice was applied to her head. She has a small lump on the left side of forehead and swollen bridge of her nose. She states she has a headache. No nausea or dizziness. She does not remember falling. Dr. wanted to get her on the table and keep her for a while. Patient was upset and wanted to go home. She stayed for about 15 min more while sitting on the floor. We got her up, Dr. walked her to check out, and asked if she needed help to the car. Mom said "No, I've got her." Patient is being seen again today on 3/14/19 for a follow up.
Age: 14.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Concussion, Emotional distress, Fall, Head injury, Headache
Clinical narrative: About 10 min after HPV was given, staff heard a yell for help. Patient was lying on the floor holding her head. Mom said she turned around for a min, then as she turned, child fell from the table. Seemed to hit her body first then head on the floor. Patient was examined by Dr. Ice was applied to her head. She has a small lump on the left side of forehead and swollen bridge of her nose. She states she has a headache. No nausea or dizziness. She does not remember falling. Dr. wanted to get her on the table and keep her for a while. Patient was upset and wanted to go home. She stayed for about 15 min more while sitting on the floor. We got her up, Dr. walked her to check out, and asked if she needed help to the car. Mom said "No, I've got her." Patient is being seen again today on 3/14/19 for a follow up.
Age: 14.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Mass, Swelling face, Syncope
Clinical narrative: About 10 min after HPV was given, staff heard a yell for help. Patient was lying on the floor holding her head. Mom said she turned around for a min, then as she turned, child fell from the table. Seemed to hit her body first then head on the floor. Patient was examined by Dr. Ice was applied to her head. She has a small lump on the left side of forehead and swollen bridge of her nose. She states she has a headache. No nausea or dizziness. She does not remember falling. Dr. wanted to get her on the table and keep her for a while. Patient was upset and wanted to go home. She stayed for about 15 min more while sitting on the floor. We got her up, Dr. walked her to check out, and asked if she needed help to the car. Mom said "No, I've got her." Patient is being seen again today on 3/14/19 for a follow up.
Age: 50.0
Sex: U
Vaccine: HEPA
Symptoms: Abnormal loss of weight, Diarrhoea, Fatigue, Headache, Pyrexia
Clinical narrative: Patient reports 20 pound unintentional weight loss, vomiting, diarrhea, fever, fatigue, and HA over last 1 1/2 months, since received Hepatitis A vaccine. Has had follow up with APRN and was advised to report as vaccine reaction. Lab testing is pending. VAQTA GIVEN / MERCK.
Age: 50.0
Sex: U
Vaccine: HEPA
Symptoms: Vomiting
Clinical narrative: Patient reports 20 pound unintentional weight loss, vomiting, diarrhea, fever, fatigue, and HA over last 1 1/2 months, since received Hepatitis A vaccine. Has had follow up with APRN and was advised to report as vaccine reaction. Lab testing is pending. VAQTA GIVEN / MERCK.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Skin warm, Swelling
Clinical narrative: On 314/19, moother reported tactile warmth & swelling, approximate "thumb-size" noted on 3/12/19.   Mother was advised to apply a cold compress & to notify our office if she notes any worsening.
Age: 1.17
Sex: M
Vaccine: HEPA, MMRV
Symptoms: Pyrexia, Rash, Rash morbilliform, Rash pruritic
Clinical narrative: Fevers the day prior, followed by pruritic morbilliform rash on trunk and back spread to face and extremities the following day. Treating with ibuprofen and diphenhydramine.
Age: 11.0
Sex: F
Vaccine: FLU4, HPV9, MNQ, TDAP
Symptoms: Dyskinesia, Head injury, Musculoskeletal stiffness, Urinary incontinence
Clinical narrative: AS STAFF WAS INJECTING THE 4TH VACCINE (WHICH WAS THE HPV) CHILDS EYES CLOSED, EXTREMITIES STIFFENED, SHE JERKED BACKWARDS HITTING HER HEAD ON THE WALL AND SHE WAS INCONTINENT OF URINE. ALL SYMPTOMS WITNESSED BY RN STAFF MEMBER. PATIENT SLOW TO AROUND BUT DID AFTER ROUGHLY 10-15 SECONDS FOLLOWING THE EVENT.
Age: 40.0
Sex: F
Vaccine: TDAP
Symptoms: Joint range of motion decreased, Musculoskeletal pain, Neck pain, Swelling
Clinical narrative: Arrived in office 1 week post injection. C/o decreased ROM, shoulder and neck pain, shoulder and neck swelling.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Erythema, Nodule
Clinical narrative: Left arm with 2x2 inch knot noted that is red. No warmth noted or signs of infections. Pt seen was office on 3/14/2019 and evaluated by MD. MD instructed patient to do symptomatic treatment only.
Age: 12.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Local reaction, Nodule, Tenderness
Clinical narrative: Pt has knot on right arm. Tender to touch. Not red or warm to touch. No signs of infection. Local reaction. MD saw in Clinic today. MD instructed to do symptomatic treatment only.
Age: 12.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Injection site nodule, Injection site pain, Local reaction
Clinical narrative: Pt has knot on right arm. Tender to touch. Not red or warm to touch. No signs of infection. Local reaction. MD saw in Clinic today. MD instructed to do symptomatic treatment only.
Age: 39.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pain, Pyrexia
Clinical narrative: Patient complains of redness, heat and swollen are about 2 in x2 in at the area surrounding the site of injection. She also complains of body aches and fever that lasted for a day.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Abnormal behaviour, Decreased appetite, Hyperhidrosis, Irritability, Pyrexia
Clinical narrative: At about 2 AM he started getting Hives all over his face & he was screaming at the top of his lungs when the rash broke out(my baby NEVER cries), ran a fever, & started sweating when the fever broke. The next day he was extremely whiny and would not eat like normal. Didn't smile like he always does. Family noticed he wasn't acting like himself.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Screaming, Urticaria
Clinical narrative: At about 2 AM he started getting Hives all over his face & he was screaming at the top of his lungs when the rash broke out(my baby NEVER cries), ran a fever, & started sweating when the fever broke. The next day he was extremely whiny and would not eat like normal. Didn't smile like he always does. Family noticed he wasn't acting like himself.
Age: 1.58
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site swelling, Wrong product administered
Clinical narrative: Patient came in 3/11/19 for an 18mo. Health check. Nurse incorrectly gave a KINRIX instead of the ordered HAVRIX. Mother called and brought patient in for a follow-up appointment on 3/14/19 to discuss redness and swelling at the injection site that started after the vaccine was given on Monday. Mother stated it was better today than it was yesterday. FNP evaluated the site, educated the mother on warning signs to keep an eye out for and was instructed to call or come back if it did not continue to improve.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Hyperaesthesia, Influenza like illness, Pain, Pain in extremity
Clinical narrative: Arm started to hurt, got a noticable red spot about 3-4 inches in diameter on front of arm, between side and armpit, Very painfull to raise arm. Could not be touched by anything for 4 days. In 4 days it was at least gently touchable. Felt flue like symptoms. Told to consult SHINGRIX if there were any adverse effects. Their site had this site as the link. Otherwise i would have reported to them. Concern as to whether this is normal and should get 2nd shot.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Injection site erythema, Malaise, Pain in extremity, Swelling
Clinical narrative: Arm started to hurt, got a noticable red spot about 3-4 inches in diameter on front of arm, between side and armpit, Very painfull to raise arm. Could not be touched by anything for 4 days. In 4 days it was at least gently touchable. Felt flue like symptoms. Told to consult SHINGRIX if there were any adverse effects. Their site had this site as the link. Otherwise i would have reported to them. Concern as to whether this is normal and should get 2nd shot.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Mobility decreased, Pain
Clinical narrative: Next day, started aching all over and felt like she was knocked out so couldn't get out of bed. Patient was basically bed ridden and can barely make it to the bathroom. Symptoms lasted for 2 day. Patient did not take medication and did not call the doctor. Symptoms have resolved completely by now. Husband received the vaccine at the same time and had similar reactions.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Insomnia, Pyrexia, Tremor
Clinical narrative: Chills, fever, shaking, insomnia.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from an administrator concerning patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant therapies, historical drugs or allergies were not reported. On 08-MAR-2019, the patient was vaccinated with one dose of improperly stored VARIVAX lot number R022117, expiry date 02-AUG-2020 (strength, dose, route and frequency were not reported) for prophylaxis. No adverse effects were reported. The administered dose of VARIVAX experienced a temperature excursion 15 fahrenheit (degrees F) to 46 degrees F (29.0 degrees F) for 4 hours and 3 minutes. With a previous temperature excursion of 6 degrees F to 14 degrees F (10.1 degrees F), (8.6 degrees F), (5.6 degrees F), (6.3 degrees F), (8.6 degrees F) for 45 hours and 27 minutes. It was not recorded by a data logger. No adverse effects were reported. No product quality complaint was involved.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On an unknown date in 2013, at approximately age 75, the patient was administered the ZOSTAVAX vaccine by a pharmacist at a pharmacy (lot number, dosage and route of administration not provided). On an unknown date, the patient was treated by a physician for the following injury resulting from his ZOSTAVAX use: Shingles. The patient claimed damages as a result of: injury to himself and economic losses. The outcome of the shingles is unknown. Additional information has been requested.
Age: 58.0
Sex: M
Vaccine: TDAP
Symptoms: Induration, Pain, Pyrexia, Swelling
Clinical narrative: Localized swelling, induration, and pain started two days after the injection and has persistent until appointment today (3/14/19).  t also has fevers but unclear if related to adult still's disease or vaccine reaction.
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Fatigue, Headache, Loss of personal independence in daily activities, Nausea
Clinical narrative: Symptoms: 3/6: nausea, dizziness, fatigue, headaches (school missed for three days); 3/9: hives, rash, fatigue, headaches, dizziness; 3/11: rash goes away, continuing with fatigue, headaches, dizziness.
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Rash, Urticaria
Clinical narrative: Symptoms: 3/6: nausea, dizziness, fatigue, headaches (school missed for three days); 3/9: hives, rash, fatigue, headaches, dizziness; 3/11: rash goes away, continuing with fatigue, headaches, dizziness.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash erythematous
Clinical narrative: The patient stated after the shot it was itchy and the shot was on the back of the arm and could not see it. On 3/13 the patient their grandchildren to look at it they stated there was a red rash on the back of the arm. The patient presented to the pharmacy and showed me the back of the arm where there was a rash on the back of the arm. Recommended the patient take benadryl and apply hydrocortisone cream to help with the reaction. Also made a mark around the rash and asked patient to keep an eye on it to make sure it does not get bigger. Asked patient to notify us if anything changes.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Arthralgia, Fatigue, Headache, Myalgia
Clinical narrative: Low grade fever, muscle aches, joint pain, headache, fatigue, upset stomach x 36 hours.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Low grade fever, muscle aches, joint pain, headache, fatigue, upset stomach x 36 hours.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypersomnia, Speech disorder
Clinical narrative: Patients daughter called and said the patient had been sleeping all day. She said she then told her to repeat a sentence she had just told her and all she could say was um. She said the patient was having trouble forming sentences. I instructed her to take the patient to the ER right away.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site cellulitis, Pain, Pyrexia, Swelling
Clinical narrative: Patient said at first she had pain, swelling, and fever which were consistent with vaccine. However, on Tuesday, March 12 the pain and redness in her shoulder increased and she said she was diagnosed with cellulitis. She said the cellulitis is from the site of injection and has been on 2 days worth of IV antibiotics.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling
Clinical narrative: Treatment- prescribed MEDROL DOSEPAK, 80 mg DEPO MEDROL IM- right buttocks. Adverse - swelling on right arm 4-5 cm below and above injection site.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Influenza like illness, Injection site pain, Loss of personal independence in daily activities
Clinical narrative: Moderate to severe pain in left shoulder which started after the injection and grew in severity for an hour or two. Shoulder pain was treated with ALEVE, but lasted for roughly 24 hours, with mild pain after that for another 6-8 hours. Headache, all-over muscle aches, and fatigue occurred on the morning following vaccination at about 6am (12 hours after vaccination). Headache was treated with BC (aspirin and caffeine), muscle aches (and continuing shoulder ache) was treated with ALEVE. Was not able to perform normal activities that day - went back to bed and slept. When out of bed was sluggish and achy, as with the flu. Symptoms abated the following morning (approx 36 hours after vaccination) and were mostly gone about 48 hours after vaccination.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Pain, Sluggishness
Clinical narrative: Moderate to severe pain in left shoulder which started after the injection and grew in severity for an hour or two. Shoulder pain was treated with ALEVE, but lasted for roughly 24 hours, with mild pain after that for another 6-8 hours. Headache, all-over muscle aches, and fatigue occurred on the morning following vaccination at about 6am (12 hours after vaccination). Headache was treated with BC (aspirin and caffeine), muscle aches (and continuing shoulder ache) was treated with ALEVE. Was not able to perform normal activities that day - went back to bed and slept. When out of bed was sluggish and achy, as with the flu. Symptoms abated the following morning (approx 36 hours after vaccination) and were mostly gone about 48 hours after vaccination.
Age: 38.0
Sex: M
Vaccine: FLUC4, PPV
Symptoms: Bone pain, Burning sensation, Cellulitis, Chills, Drug hypersensitivity
Clinical narrative: Pt. was given vaccines (FLUCELVAX and PNEUMOVAX) on his left Deltoid 03/11/19, was seen by a provider the following day, 03/12/19  for fever and was prescribed doxycycline tablet, hyclate 100 mg, 1 tab(s), orally, 2 times a day x 10 days. Pt. returned 03/14/19 to see PCP, c/o left arm swelling and burning , fever, shaking, unable to move arms every bone in by body started hurting, bone aches,  chills. Diagnosis of left arm cellulitis, allergy to antibiotics. Prescribed tramadol tablet, 50 mg, 1 tab(s), orally, every 8 hours, 3 days. Scheduled a f/u with a provider on 03/25/19.
Age: 38.0
Sex: M
Vaccine: FLUC4, PPV
Symptoms: Mobility decreased, Peripheral swelling, Pyrexia, Tremor
Clinical narrative: Pt. was given vaccines (FLUCELVAX and PNEUMOVAX) on his left Deltoid 03/11/19, was seen by a provider the following day, 03/12/19  for fever and was prescribed doxycycline tablet, hyclate 100 mg, 1 tab(s), orally, 2 times a day x 10 days. Pt. returned 03/14/19 to see PCP, c/o left arm swelling and burning , fever, shaking, unable to move arms every bone in by body started hurting, bone aches,  chills. Diagnosis of left arm cellulitis, allergy to antibiotics. Prescribed tramadol tablet, 50 mg, 1 tab(s), orally, every 8 hours, 3 days. Scheduled a f/u with a provider on 03/25/19.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Dizziness, Dysstasia, Feeling cold, Hyperhidrosis
Clinical narrative: I felt ok and then about 7 hours later I had extreme chills, shaking uncontrollably, put heat on mattress pad, double up on clothes, turned on a heating pad and kept moving it around my body. I got up to urinate several times; I was extremely dizzy, my heart was racing, I finally broke out into a sweat - I thought I might have a fever but didn't have strength to get a thermometer. I actually lost 1.5 lbs I think from sweating and urinating. Not because of any diet. I was so weak. Felt like the worse flu I ever had and my heart was beating so fast. I could stand up for long period. I went back to bed fell asleep. Couldn't eat etc.. Around 2:00 this afternoon 3/14/2019 I finally started to feel better but still weak. Felt like I had been through the ringer sort of speak.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Palpitations, Tremor, Weight decreased
Clinical narrative: I felt ok and then about 7 hours later I had extreme chills, shaking uncontrollably, put heat on mattress pad, double up on clothes, turned on a heating pad and kept moving it around my body. I got up to urinate several times; I was extremely dizzy, my heart was racing, I finally broke out into a sweat - I thought I might have a fever but didn't have strength to get a thermometer. I actually lost 1.5 lbs I think from sweating and urinating. Not because of any diet. I was so weak. Felt like the worse flu I ever had and my heart was beating so fast. I could stand up for long period. I went back to bed fell asleep. Couldn't eat etc.. Around 2:00 this afternoon 3/14/2019 I finally started to feel better but still weak. Felt like I had been through the ringer sort of speak.
Age: 86.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Pruritus, Rash generalised
Clinical narrative: ITCHING BEGINNING IN MIDDLE OF NIGHT WOKE UP WITH A RASH ON ALL OF BODY.
Age: 86.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Hypersensitivity, Pain, Pruritus generalised, Rash
Clinical narrative: ITCHING BEGINNING IN MIDDLE OF NIGHT WOKE UP WITH A RASH ON ALL OF BODY.
Age: 59.0
Sex: F
Vaccine: TDAP
Symptoms: Pain, Pain in extremity
Clinical narrative: Pain to Left arm, worsening over the last 8 days. Painful to raise arm over head, 7/10 and painful to move across body. Denies warmth, swelling, fever, puffiness, redness.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Eye irritation, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness, pain and swelling at injection site, joint and muscle pain, burning eyes, feverish.