chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 88.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Cough, Dysphonia, Dyspnoea, Myalgia
Clinical narrative: shortness of breath; vomiting; coughing; became hoarse; fever; muscle pain within hours of the injection; chills; This case was reported by a pharmacist via call center representative and described the occurrence of muscle pain in a 88-year-old female patient who received Herpes zoster (Shingrix) (batch number H25YE, expiry date 4th December 2021) for prophylaxis.   The patient's past medical history included lung disorder and cardiac monitoring (the doctor had some concern over her heart so she was wearing a heart monitor for 2 weeks. No specific reason was given for the need of a heart monitor). Previously administered products included Shingrix with an associated reaction of no adverse event (first dose received within 2 to 6 months before the 2nd dose).   On 26th February 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 26th February 2020, less than a day after receiving Shingrix, the patient experienced muscle pain and chills. On 28th February 2020, the patient experienced vomiting, cough, hoarseness and fever. On 29th February 2020, the patient experienced shortness of breath. On an unknown date, the outcome of the muscle pain, chills, vomiting, cough, hoarseness, fever and shortness of breath were unknown.   It was unknown if the reporter considered the muscle pain, chills, vomiting, cough, hoarseness, fever and shortness of breath to be related to Shingrix.  Additional information was provided as follows: The patient started to experience muscle pain within hours of the injection.  Chills began later that day. 2 days after receiving vaccine, patient had the chills but began to vomit, cough, became hoarse and started to run a fever. On that Saturday, she started to have severe shortness of breath. On Sunday her temperature went down. On Monday, she went to the physician tor even though it felt the worse was behind her. The physician had some concern over her heart so she is wearing a heart monitor for 2 weeks. No specific reason was given for the need of a heart monitor. Emergency room visit required.
Age: 88.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Vomiting
Clinical narrative: shortness of breath; vomiting; coughing; became hoarse; fever; muscle pain within hours of the injection; chills; This case was reported by a pharmacist via call center representative and described the occurrence of muscle pain in a 88-year-old female patient who received Herpes zoster (Shingrix) (batch number H25YE, expiry date 4th December 2021) for prophylaxis.   The patient's past medical history included lung disorder and cardiac monitoring (the doctor had some concern over her heart so she was wearing a heart monitor for 2 weeks. No specific reason was given for the need of a heart monitor). Previously administered products included Shingrix with an associated reaction of no adverse event (first dose received within 2 to 6 months before the 2nd dose).   On 26th February 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 26th February 2020, less than a day after receiving Shingrix, the patient experienced muscle pain and chills. On 28th February 2020, the patient experienced vomiting, cough, hoarseness and fever. On 29th February 2020, the patient experienced shortness of breath. On an unknown date, the outcome of the muscle pain, chills, vomiting, cough, hoarseness, fever and shortness of breath were unknown.   It was unknown if the reporter considered the muscle pain, chills, vomiting, cough, hoarseness, fever and shortness of breath to be related to Shingrix.  Additional information was provided as follows: The patient started to experience muscle pain within hours of the injection.  Chills began later that day. 2 days after receiving vaccine, patient had the chills but began to vomit, cough, became hoarse and started to run a fever. On that Saturday, she started to have severe shortness of breath. On Sunday her temperature went down. On Monday, she went to the physician tor even though it felt the worse was behind her. The physician had some concern over her heart so she is wearing a heart monitor for 2 weeks. No specific reason was given for the need of a heart monitor. Emergency room visit required.
Age: 66.0
Sex: F
Vaccine: TDAP, VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Injection site redness; Injection site swelling; Injection site pain on left arm; This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 67-year-old female patient who received Herpes zoster (Shingrix) (batch number 3L3PR, expiry date 11th December 2021) and (batch number 45N3Y, expiry date 21st January 2022) for prophylaxis.   Co-suspect products included DTPa (Reduced antigen) (Boostrix) for prophylaxis.   The patient's past medical history included drug allergy.   On 28th October 2019, the patient received the 1st dose of Shingrix. On an unknown date, the dose was an unknown dose. On 28th October 2019, the patient received Boostrix. On an unknown date, less than 5 months after receiving Shingrix and Boostrix, the patient experienced injection site erythema, injection site swelling and injection site pain. On an unknown date, the outcome of the injection site erythema, injection site swelling and injection site pain were unknown.   It was unknown if the reporter considered the injection site erythema, injection site swelling and injection site pain to be related to Shingrix and Boostrix.  Additional case details were reported as follows: The patient received vaccine in left arm. The patient experienced an allergic reaction at injection site after dose one of Shingrix. The patient also received Boostrix on same date. The reporter described allergic reaction as injection site swelling, redness, and pain on left arm. The reporter consented to follow up.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Feeling hot, Herpes zoster, Rash, Tenderness
Clinical narrative: shingles outbreak; Sunburn feeling on head; small rash on left pectoral; tenderness in leg/groin area; This case was reported by a other health professional via call center representative and described the occurrence of shingles in a 52-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In February 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced shingles, feeling of warmth facial, rash and tenderness. On an unknown date, the outcome of the shingles, feeling of warmth facial, rash and tenderness were unknown.   It was unknown if the reporter considered the shingles, feeling of warmth facial, rash and tenderness to be related to Shingrix.  Additional details were provided as follows: The reporter did not give an address when asked about administering provider. A respiratory therapist reported that he received the dose of Shingrix ( last week Wednesday or Thursday) and later experienced symptoms of a shingles outbreak. (Sunburn feeling on head, small rash on left pectoral, tenderness in leg/groin area). Consented to follow up.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Joint noise, Muscular weakness, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: pain at injection site right arm; stiffness; kink upper right arm joint; weakness in her upper right arm; pain in her upper right arm; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In November 2019, the patient received the 2nd dose of Shingrix. In November 2019, less than a week after receiving Shingrix, the patient experienced injection site pain and pain in arm. On an unknown date, the patient experienced stiffness, joint clicking and weakness of arms. In November 2019, the outcome of the injection site pain was recovered/resolved. On an unknown date, the outcome of the pain in arm, stiffness and joint clicking were unknown and the outcome of the weakness of arms was not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, pain in arm, stiffness, joint clicking and weakness of arms to be related to Shingrix.  Additional details were provided as follows: Four and half months before the date of reporting, the patient received Shingrix in the right arm. The first week after receiving the injection, she experienced pain at the injection site, right arm. In the second week of vaccination, the injection site was not painful but started experiencing sharp pain in her upper right arm when she reached to grab something or moving her arm sideways to the right.  Less than 2 months after vaccination, the patient experienced stiffness, joint clicking and weakness of arms. She also noticed that when she moved her arm backwards she experienced stiffness and when she rotated the arm she heard and felt a kink in her upper right arm joint.  She also reported that she was experiencing weakness in her upper right arm. The patient had an appointment with a nurse practitioner on 21st April 2020. The patient consented to follow up.
Age: 62.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Arthralgia, Incorrect route of product administration, Injected limb mobility decreased, Joint range of motion decreased, Myalgia
Clinical narrative: muscle pain; joint pain; left shoulder mobility decreased; left shoulder mobility decreased; Inappropriate route of vaccination; This case was reported by a physician via sales rep and described the occurrence of muscle pain in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included INFLUENZA VACCINE for prophylaxis.   On 5th December 2019, the patient received the 1st dose of Shingrix and INFLUENZA VACCINE (intramuscular). On 5th December 2019, less than a day after receiving Shingrix, the patient experienced muscle pain, joint pain, injected limb mobility decreased, joint range of motion decreased and inappropriate route of vaccination. On an unknown date, the outcome of the muscle pain, joint pain, injected limb mobility decreased and joint range of motion decreased were not recovered/not resolved and the outcome of the inappropriate route of vaccination was unknown.   It was unknown if the reporter considered the muscle pain, joint pain, injected limb mobility decreased and joint range of motion decreased to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in left arm and INFLUENZA VACCINE (unknown name by Sanofi) in right arm. The patient experienced joint pain and muscle pain that started in both shoulders, and moved to only the right shoulder. Also, the physician reported that the patient stated that the Shingrix was given higher up into the deltoid muscle, this led to inappropriate route of vaccination. The physician reported that the patient refused treatment and the issues were still unresolved. Consented to follow up.
Age: 71.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Accidental exposure to product, Accidental underdose, Exposure via skin contact, Fatigue, Hot flush
Clinical narrative: Fatigue; achy body; dose may have been given Subcutaneously; received an incomplete 1st dose of Shingrix; During administration leaked on the patient's arm; exposure via skin contact; experienced tingling throughout his body; experienced episodes of hot flashes, multiple, runs through his entire body; This case was reported by a physician via call center representative and described the occurrence of fatigue in a 71-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 6th March 2020, the patient received Shingrix (subcutaneous) and the 1st dose of Shingrix. On 6th March 2020, immediately after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced fatigue, general body pain, intramuscular formulation administered by other route, accidental underdose, inadvertent exposure to vaccine and exposure via skin contact. In March 2020, the patient experienced tingling and hot flashes. On an unknown date, the outcome of the fatigue, general body pain, tingling, hot flashes, intramuscular formulation administered by other route, accidental underdose, inadvertent exposure to vaccine and exposure via skin contact were unknown.   It was unknown if the reporter considered the fatigue, general body pain, tingling and hot flashes to be related to Shingrix.  Additional details were provided as follows: The reporter was the daughter of the patient. A physician reported that a patient received an incomplete 1st dose of Shingrix. During administration leaked on the patient's arm, then they were given a full dose immediately, which led to accidental underdose, inadvertent exposure to vaccine and exposure via skin contact. The provider reported the dose may have been given subcutaneously, which led to incorrect route of vaccination. The provider also reported that the patient experienced episodes of hot flashes, multiple, runs through his entire body and tingling throughout his body. Initially fatigue, achy body reported immediately after the dose and 1 week later the other symptoms developed. Consented to follow up.
Age: 71.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Immediate post-injection reaction, Incorrect route of product administration, Pain, Paraesthesia
Clinical narrative: Fatigue; achy body; dose may have been given Subcutaneously; received an incomplete 1st dose of Shingrix; During administration leaked on the patient's arm; exposure via skin contact; experienced tingling throughout his body; experienced episodes of hot flashes, multiple, runs through his entire body; This case was reported by a physician via call center representative and described the occurrence of fatigue in a 71-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 6th March 2020, the patient received Shingrix (subcutaneous) and the 1st dose of Shingrix. On 6th March 2020, immediately after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced fatigue, general body pain, intramuscular formulation administered by other route, accidental underdose, inadvertent exposure to vaccine and exposure via skin contact. In March 2020, the patient experienced tingling and hot flashes. On an unknown date, the outcome of the fatigue, general body pain, tingling, hot flashes, intramuscular formulation administered by other route, accidental underdose, inadvertent exposure to vaccine and exposure via skin contact were unknown.   It was unknown if the reporter considered the fatigue, general body pain, tingling and hot flashes to be related to Shingrix.  Additional details were provided as follows: The reporter was the daughter of the patient. A physician reported that a patient received an incomplete 1st dose of Shingrix. During administration leaked on the patient's arm, then they were given a full dose immediately, which led to accidental underdose, inadvertent exposure to vaccine and exposure via skin contact. The provider reported the dose may have been given subcutaneously, which led to incorrect route of vaccination. The provider also reported that the patient experienced episodes of hot flashes, multiple, runs through his entire body and tingling throughout his body. Initially fatigue, achy body reported immediately after the dose and 1 week later the other symptoms developed. Consented to follow up.
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Headache, Hypoaesthesia
Clinical narrative: C/o right arm numbness occasionally for three weeks post-injection, along with headache.  Took ibuprofen as needed.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect route of product administration, Injection site pain
Clinical narrative: Pain at injection site; received the first dose of Shingrix via subcutaneous route; This case was reported by a nurse via call center representative and described the occurrence of injection site pain in a 64-year-old male patient who received Herpes zoster (Shingrix) (batch number 22S3B, expiry date 25th March 2022) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (subcutaneous). On an unknown date, unknown after receiving Shingrix, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route was unknown.  Additional information was provided as follows: The age at vaccination was not reported. The age group was captured as adult as per vaccine indication. Nurse reported that 17 patients received the first dose of Shingrix via subcutaneous route, which led to intramuscular formulation administered by other route. Some of them were female patients. Nurse did not provide initials, date of birth, lot number and expiration dates of the vaccines. She did not said how many patients were male and how many were female. This is 1 of the 17 cases, reported by same reporter.   Follow up information received from the nurse on 3rd April 2020: The patient's demographic details were updated. Concurrent medical conditions included gastroesophageal reflux disease (started on 17th October 2010), coronary artery calcification (started on 28th November 2017) and chronic cough (started on 28th November 2017).  On 16th January 2020, the patient received the 1st dose of Shingrix (subcutaneous). The batch number and expiry date details were updated. On 16th January 2020, less than a day after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved. The reporter considered the injection site pain to be unrelated to Shingrix. The VAERS details were updated.
Age: 17.0
Sex: U
Vaccine: MENB
Symptoms: Dizziness, Feeling cold, Immediate post-injection reaction, Injected limb mobility decreased, Injection site pain
Clinical narrative: NAUSEA; DIZZY; FREEZING COLD; her face was sheet white; FAINT; ARM PAIN / injection site pain; injection site pain; This case was reported by a nurse via call center representative and described the occurrence of faint in a 17-year-old female patient who received Men B NVS (Bexsero) (batch number ABX796AZ, expiry date 30th September 2020) for prophylaxis.   On 20th March 2020 02:30, the patient received the 1st dose of Bexsero. On 20th March 2020, 5 hrs 30 min after receiving Bexsero, the patient experienced pain in arm and injected limb mobility decreased. On 20th March 2020 08:00, the patient experienced faint (serious criteria GSK medically significant), nausea, dizziness, feeling cold and skin discoloration. On 21st March 2020, the outcome of the faint, nausea, dizziness, feeling cold, skin discoloration and injected limb mobility decreased were recovered/resolved. On an unknown date, the outcome of the pain in arm was recovering/resolving.   It was unknown if the reporter considered the faint, pain in arm, nausea, dizziness, feeling cold, skin discoloration and injected limb mobility decreased to be related to Bexsero.  Additional details were reported as follows: This case was reported by the patient's mother, who was nurse. At 2:30 PM, the patient received a dose of Bexsero on the left arm. The injection site arm pain was immediate and had not completely resolved. At approximately 8:00 PM the day of the vaccination, all other symptoms were presented and lasted throughout the night. The patient's mother reported that her face was sheet white and she was freezing, nauseous and very faint.  The patient also couldn't move her arm that night. The symptoms with the exception of the arm pain, resolved the next day. The reporter consented to follow up.
Age: 17.0
Sex: U
Vaccine: MENB
Symptoms: Nausea
Clinical narrative: NAUSEA; DIZZY; FREEZING COLD; her face was sheet white; FAINT; ARM PAIN / injection site pain; injection site pain; This case was reported by a nurse via call center representative and described the occurrence of faint in a 17-year-old female patient who received Men B NVS (Bexsero) (batch number ABX796AZ, expiry date 30th September 2020) for prophylaxis.   On 20th March 2020 02:30, the patient received the 1st dose of Bexsero. On 20th March 2020, 5 hrs 30 min after receiving Bexsero, the patient experienced pain in arm and injected limb mobility decreased. On 20th March 2020 08:00, the patient experienced faint (serious criteria GSK medically significant), nausea, dizziness, feeling cold and skin discoloration. On 21st March 2020, the outcome of the faint, nausea, dizziness, feeling cold, skin discoloration and injected limb mobility decreased were recovered/resolved. On an unknown date, the outcome of the pain in arm was recovering/resolving.   It was unknown if the reporter considered the faint, pain in arm, nausea, dizziness, feeling cold, skin discoloration and injected limb mobility decreased to be related to Bexsero.  Additional details were reported as follows: This case was reported by the patient's mother, who was nurse. At 2:30 PM, the patient received a dose of Bexsero on the left arm. The injection site arm pain was immediate and had not completely resolved. At approximately 8:00 PM the day of the vaccination, all other symptoms were presented and lasted throughout the night. The patient's mother reported that her face was sheet white and she was freezing, nauseous and very faint.  The patient also couldn't move her arm that night. The symptoms with the exception of the arm pain, resolved the next day. The reporter consented to follow up.
Age: 25.0
Sex: M
Vaccine: ANTH, JEV1, SMALL, TYP
Symptoms: Axillary pain, Injection site erythema, Injection site pain, Injection site swelling, Swelling
Clinical narrative: presented to clinic on 03/11/2020 with c/o swelling, pain & tenderness of the upper left arm / axillary - Pt was seen on 09mar2020 for a smallpox "take check" with normal results. Pt states the site continued to get more red & swollen over the past 2 days - pt states he has not taken anything for the pain & swelling. Increased redness around smallpox site with increased swelling in left axillary compared to initial "Take Check" on 09mar2020. Pt also states he feels pulsating upon rest. Pt denied chest pain & difficulty breathing Pt showed facial grimacing upon palpation of left axillary area. Provider notified.
Age: 25.0
Sex: M
Vaccine: ANTH, JEV1, SMALL, TYP
Symptoms: Tenderness
Clinical narrative: presented to clinic on 03/11/2020 with c/o swelling, pain & tenderness of the upper left arm / axillary - Pt was seen on 09mar2020 for a smallpox "take check" with normal results. Pt states the site continued to get more red & swollen over the past 2 days - pt states he has not taken anything for the pain & swelling. Increased redness around smallpox site with increased swelling in left axillary compared to initial "Take Check" on 09mar2020. Pt also states he feels pulsating upon rest. Pt denied chest pain & difficulty breathing Pt showed facial grimacing upon palpation of left axillary area. Provider notified.
Age: 79.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Dyspnoea, Myalgia, Pyrexia
Clinical narrative: Patient states that he experienced fever, shortness of breath, and his muscles ached and were extremely weak. Patient reported symptoms to pharmacy on day 13 after the vaccine was given. Patient recovered shortly after reporting symptoms to the pharmacy.
Age: 25.0
Sex: F
Vaccine: HEP
Symptoms: Injection site pain, Injection site paraesthesia, Injection site pruritus, Injection site warmth
Clinical narrative: Employee states that she feels pain, warmth, tingling and some times itching at the site.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No symptoms reported; patient received unspecified dose of either a V ARIVAX or a PROQUAD dose that was improperly stored; This spontaneous report was received from a medical assistant, referring 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 10-FEB-2020, the patient received unspecified dose of improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) injection (lot # S025610, expiration date 18-AUG-2021) (strength, dose and route were unknown) or measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, recombinant human albumin (rHA) (lot # S017250, expiration date 01-DEC-2020), (strength, dose and route were unknown) both for prophylaxis, diluted in properly stored sterile diluent. The vaccine was exposed to temperature excursion at 7.5 degrees Fahrenheit for 15 minutes (incorrect product storage). There was no previous temperature excursion. The call was due to digital data logger. No symptoms were reported.; Sender's Comments:  US-009507513-2003USA006861:
Sex: U
Vaccine: VARZOS
Symptoms: Deafness
Clinical narrative: hearing loss; This spontaneous report has been received on 02-APR-2020 from a lawyer, regarding a case in litigation and refers to a patient of an unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown date in 2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiry date were not provided) for the long-term prevention of shingles and/or zoster-related conditions at a hospital. Subsequent to the patient's zoster vaccine live (ZOSTAVAX) inoculation, on an unknown date, the patient was treated by a healthcare provided for hearing loss. As a direct and proximate result of the patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, the patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of hearing loss was not reported. The reporter considered the hearing loss to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review, the event of hearing loss was considered to be medically significant.
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Lethargy, Pain, Pyrexia
Clinical narrative: mild fever; body aches; lethargy; severely red upper arm to elbow; This case was reported by a other health professional via interactive digital media and described the occurrence of fever in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced fever, general body pain, lethargy and erythema of extremities. On an unknown date, the outcome of the fever, general body pain, lethargy and erythema of extremities were unknown.   It was unknown if the reporter considered the fever, general body pain, lethargy and erythema of extremities to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication. The patient experienced mild fever, body aches, lethargyand had severely red upper arm to elbowafter receiving Shingrix vaccine. No other information was reported.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Anal pruritus, Ear pruritus, Erythema, Eye pruritus, Eye swelling
Clinical narrative: rash; rash looks like little red dots, it itches and it covers the following areas of her body; Anal pruritus; itches on her ears; rash also covers around her left eye; her left eye is swollen; redness under the right eye; her body was aching; fever; redness at the injection site; irritated bump at the injection site; felt like she had the flu; This case was reported by a consumer via call center representative and described the occurrence of influenza like illness in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (received 1st dose on 4th October 2019, refer case US2020046892). Concurrent medical conditions included rheumatoid arthritis.   On 13th March 2020, the patient received the 2nd dose of Shingrix. On 13th March 2020, less than a day after receiving Shingrix, the patient experienced itchy rash, red rash, anal pruritus, ear pruritus, eye pruritus, eye swelling and erythema periorbital. In March 2020, the patient experienced influenza like illness, general body pain, fever, injection site erythema and injection site swelling. The patient was treated with certolizumab (Cimzia) and methotrexate. On an unknown date, the outcome of the influenza like illness, general body pain, fever, injection site erythema and injection site swelling were resolved with sequelae and the outcome of the itchy rash, red rash, anal pruritus, ear pruritus, eye pruritus, eye swelling and erythema periorbital were recovering/resolving.   It was unknown if the reporter considered the influenza like illness, itchy rash, red rash, anal pruritus, ear pruritus, eye pruritus, eye swelling, erythema periorbital, general body pain, fever, injection site erythema and injection site swelling to be related to Shingrix.  Additional case details were reported as follows: The patient stated that after 2nd dose started having a rash looks like little red dots, it itches and it covers the following areas of her body: around the neck, on the chest, down the right arm, on the top of the left arm, down her left leg, on her belly, on her anus, on her ears (both).  The rash also covers around her left eye and that her left eye is swollen. The patient also had redness under the right eye but no rash. The patient also felt like she had the flu and her body was aching and she had a fever of 100.7 degree F and also had redness at the injection site, and an irritated bump at the injection site. The patient consented to follow up.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site erythema, Injection site irritation, Injection site swelling, Pain
Clinical narrative: rash; rash looks like little red dots, it itches and it covers the following areas of her body; Anal pruritus; itches on her ears; rash also covers around her left eye; her left eye is swollen; redness under the right eye; her body was aching; fever; redness at the injection site; irritated bump at the injection site; felt like she had the flu; This case was reported by a consumer via call center representative and described the occurrence of influenza like illness in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (received 1st dose on 4th October 2019, refer case US2020046892). Concurrent medical conditions included rheumatoid arthritis.   On 13th March 2020, the patient received the 2nd dose of Shingrix. On 13th March 2020, less than a day after receiving Shingrix, the patient experienced itchy rash, red rash, anal pruritus, ear pruritus, eye pruritus, eye swelling and erythema periorbital. In March 2020, the patient experienced influenza like illness, general body pain, fever, injection site erythema and injection site swelling. The patient was treated with certolizumab (Cimzia) and methotrexate. On an unknown date, the outcome of the influenza like illness, general body pain, fever, injection site erythema and injection site swelling were resolved with sequelae and the outcome of the itchy rash, red rash, anal pruritus, ear pruritus, eye pruritus, eye swelling and erythema periorbital were recovering/resolving.   It was unknown if the reporter considered the influenza like illness, itchy rash, red rash, anal pruritus, ear pruritus, eye pruritus, eye swelling, erythema periorbital, general body pain, fever, injection site erythema and injection site swelling to be related to Shingrix.  Additional case details were reported as follows: The patient stated that after 2nd dose started having a rash looks like little red dots, it itches and it covers the following areas of her body: around the neck, on the chest, down the right arm, on the top of the left arm, down her left leg, on her belly, on her anus, on her ears (both).  The rash also covers around her left eye and that her left eye is swollen. The patient also had redness under the right eye but no rash. The patient also felt like she had the flu and her body was aching and she had a fever of 100.7 degree F and also had redness at the injection site, and an irritated bump at the injection site. The patient consented to follow up.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia, Rash erythematous, Rash pruritic
Clinical narrative: rash; rash looks like little red dots, it itches and it covers the following areas of her body; Anal pruritus; itches on her ears; rash also covers around her left eye; her left eye is swollen; redness under the right eye; her body was aching; fever; redness at the injection site; irritated bump at the injection site; felt like she had the flu; This case was reported by a consumer via call center representative and described the occurrence of influenza like illness in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (received 1st dose on 4th October 2019, refer case US2020046892). Concurrent medical conditions included rheumatoid arthritis.   On 13th March 2020, the patient received the 2nd dose of Shingrix. On 13th March 2020, less than a day after receiving Shingrix, the patient experienced itchy rash, red rash, anal pruritus, ear pruritus, eye pruritus, eye swelling and erythema periorbital. In March 2020, the patient experienced influenza like illness, general body pain, fever, injection site erythema and injection site swelling. The patient was treated with certolizumab (Cimzia) and methotrexate. On an unknown date, the outcome of the influenza like illness, general body pain, fever, injection site erythema and injection site swelling were resolved with sequelae and the outcome of the itchy rash, red rash, anal pruritus, ear pruritus, eye pruritus, eye swelling and erythema periorbital were recovering/resolving.   It was unknown if the reporter considered the influenza like illness, itchy rash, red rash, anal pruritus, ear pruritus, eye pruritus, eye swelling, erythema periorbital, general body pain, fever, injection site erythema and injection site swelling to be related to Shingrix.  Additional case details were reported as follows: The patient stated that after 2nd dose started having a rash looks like little red dots, it itches and it covers the following areas of her body: around the neck, on the chest, down the right arm, on the top of the left arm, down her left leg, on her belly, on her anus, on her ears (both).  The rash also covers around her left eye and that her left eye is swollen. The patient also had redness under the right eye but no rash. The patient also felt like she had the flu and her body was aching and she had a fever of 100.7 degree F and also had redness at the injection site, and an irritated bump at the injection site. The patient consented to follow up.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood pressure increased, Computerised tomogram, Headache, Herpes zoster
Clinical narrative: blood pressure was notably high; Shingles; severe pain on the top life side of her head; This case was reported by a nurse via call center representative and described the occurrence of shingles in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23rd August 2019, the patient received the 1st dose of Shingrix. On 21st February 2020, 182 days after receiving Shingrix and an unknown time after starting Valacyclovir, the patient experienced shingles and headache. On 22nd February 2020, the patient experienced increased blood pressure. The patient was treated with valaciclovir hydrochloride (Valacyclovir). On an unknown date, the outcome of the shingles, headache and increased blood pressure were unknown.   It was unknown if the reporter considered the shingles, headache and increased blood pressure to be related to Shingrix.  Additional case details were reported as follows: The patient experienced shingles, headache and increased blood pressure after 1st dose of Shingrix. The patient went to emergency room and underwent a CT scan. The patient blood pressure was high due to severe pain. The patient had no blisters on her head or on her scalp and wanted to receive 2nd dose Shingrix as soon as possible. The patient was not administered with the vaccine because she is taking antivirals. The patient consented to follow up.
Age: 24.0
Sex: F
Vaccine: HEP, VARCEL
Symptoms: Injection site vesicles, Pruritus, Rash
Clinical narrative: Itching and rash started two days after injection.  Developed blister at site of Varivax on day three.
Age: 29.0
Sex: M
Vaccine: HEP
Symptoms: Dizziness, Feeling hot, Hyperhidrosis, Hypotonia, Immediate post-injection reaction
Clinical narrative: After completing his plasma donation, the donor was administered his first Hepatitis B vaccine of his 3-shot series. The vaccine was administered in the deltoid muscle of his right arm while he was seated upright in a chair.  Immediately after the vaccine was given, the donor lost consciousness for less than 10 seconds.  His body went limp, and his head went down to his chest.  Symptoms included lightheadedness, feeling hot/sweaty, and pale appearance.  Donor was provided Powerade, crackers, and was fanned.  Vital signs were obtained and were at his baseline measurement.  Donor then stated he was feeling better and his symptoms subsided.  Vitals were obtained again and were at his baseline.  Donor recovered appropriately and left center in good condition.
Age: 29.0
Sex: M
Vaccine: HEP
Symptoms: Loss of consciousness, Pallor, Posture abnormal
Clinical narrative: After completing his plasma donation, the donor was administered his first Hepatitis B vaccine of his 3-shot series. The vaccine was administered in the deltoid muscle of his right arm while he was seated upright in a chair.  Immediately after the vaccine was given, the donor lost consciousness for less than 10 seconds.  His body went limp, and his head went down to his chest.  Symptoms included lightheadedness, feeling hot/sweaty, and pale appearance.  Donor was provided Powerade, crackers, and was fanned.  Vital signs were obtained and were at his baseline measurement.  Donor then stated he was feeling better and his symptoms subsided.  Vitals were obtained again and were at his baseline.  Donor recovered appropriately and left center in good condition.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Rash
Clinical narrative: FULL BODY RASH FOR ABOUT 2 WKS
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site pain, Nausea
Clinical narrative: The patient contacted the pharmacy today stating that she got her second Shingrix vaccine on friday, and Saturday night her arm became sore and red around the injection site. She also developed a headache and nausea and is unsure if that was from the vaccine or something unrelated. I told her the soreness and redness is common after a vaccine and could last a few days to a week but the headache and nausea are not. She asked if she should contact her doctor and I told her that would probably be a good idea. I told her she could take motrin or tylenol if the pain is bothersome and could ice the area as well.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Extra dose administered
Clinical narrative: received 2 doses of GARDASIL 9 by mistake; This initial spontaneous report was received from a physician and refers to a 12-year-old female patient. This report concerns 1 patient and 1 combination product. The patient's pertinent medical history, drug reactions or allergies were not reported. Concomitant therapies included diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid, varicella virus vaccine live (oka/merck) (VARIVAX) and meningococcal acyw conj vaccine (carrier unspecified).  On 11-MAR-2020, by mistake, the patient was vaccinated with 2 doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (lot # R030456; expiration date was reported as 20-JUL-2021, but upon internal validation established as 23-JUL-2021) (exact dose, route of administration and anatomical location were not reported) for prophylaxis.
Sex: U
Vaccine: VARZOS
Symptoms: Cardiac failure
Clinical narrative: heart failure; This spontaneous report has been received on 02-APR-2020 from a lawyer, regarding a case in litigation and refers to a patient of an unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown date in 2017, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiry date were not provided) for the long-term prevention of shingles and/or zoster-related conditions as prescribed and/or administered by a pharmacist at a pharmacy. Subsequent to the patient's zoster vaccine live (ZOSTAVAX) inoculation, on an unknown date, the patient was treated by a physician for heart failure. As a direct and proximate result of the patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, the patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of heart failure was not reported. The reporter considered the heart failure to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review, the event of heart failure was considered to be medically significant.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This spontaneous report has been received on 02-APR-2020 from a lawyer, regarding a case in litigation and refers to a patient of an unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown date in 2016, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiry date were not provided) for the long-term prevention of shingles and/or zoster-related conditions as prescribed and/or administered by a pharmacist at a pharmacy. Subsequent to the patient's zoster vaccine live (ZOSTAVAX) inoculation, on an unknown date, the patient was treated by a physician for shingles. As a direct and proximate result of the patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, the patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of shingles was not reported. The reporter considered the shingles to be related to zoster vaccine live (ZOSTAVAX).
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site pain, Limb discomfort, Night sweats
Clinical narrative: Heaviness feeling in injection site arm; shivering / chills; night sweats; tenderness at injection site; This case was reported by a consumer via call center representative and described the occurrence of heaviness in arm in a 85-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included cataract (right eye surgery on 23rd January 2020) and glaucoma. Concomitant products included thyroxine sodium (Levothyroxine), brimonidine tartrate (Alphagan) and latanoprost (Xalatan).   On 17th January 2020, the patient received the 1st dose of Shingrix (intramuscular). On 17th January 2020, less than a day after receiving Shingrix, the patient experienced injection site tenderness. On 27th January 2020, the patient experienced shivering and night sweat. On 19th March 2020, the patient experienced heaviness in arm. On an unknown date, the outcome of the heaviness in arm, injection site tenderness and night sweat were recovering/resolving and the outcome of the shivering was recovered/resolved.   It was unknown if the reporter considered the heaviness in arm, injection site tenderness, shivering and night sweat to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in right arm. The patient planned to continue follow-up with her physician on an unknown date. Consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Chemotherapy, Radiotherapy
Clinical narrative: Radiation; Chemotherapy; This case was reported by a pharmacist via call center representative and described the occurrence of radiation therapy in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced radiation therapy and chemotherapy. On an unknown date, the outcome of the radiation therapy and chemotherapy were unknown.   It was unknown if the reporter considered the radiation therapy and chemotherapy to be related to Shingrix.   Additional details were provided as follows: The age at vaccination was not reported. The pharmacist reported that a patient started radiation and chemotherapy after receiving the 1st dose of Shingrix. No additional information was given. The pharmacist consented to follow up.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Feeling cold, Headache
Clinical narrative: Shivering Headache Cold Weak
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Fall, Gait disturbance, Peripheral swelling, Walking aid user
Clinical narrative: I was fine for 12 hours. At 930PM bilateral legs to ankles were 3" larger-at 2AM 3-6-20 had a bathroom call & fell out of bed on my butt I could not walk without a cane until Friday the 13th of March. Friday the 13th of The only comfort I had was ice packs and Motrin 800mg Q 8 hrs. I hope I was helpful with my description
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Injection site inflammation
Clinical narrative: INFLAMMATION TO INJECTION SITE
Age: 1.92
Sex: M
Vaccine: DTAPHEPBIP, FLU4
Symptoms: Injection site cellulitis
Clinical narrative: large cellulitis to the right thigh
Age: 0.33
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC13
Symptoms: Emotional distress, Encephalitis, High-pitched crying, Opisthotonus
Clinical narrative: Uncontrollable high pitch crying for 3+ hrs. Unable to soothe. Arching if laying flat. Encephalitis signs and symptoms.