chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Pyrexia, Rash, Rhinorrhoea, Sneezing
Clinical narrative: Constant pain in area of shot.   Tuesday started being cold, Wednesday went from cold to shivers then fever of 102.2 Thursday off and on cold to being hot.  Friday woke up with sniffles and  extreme pain in inner arm just below armpit, later in evening a huge rash on upper left arm.  Friday woke up with pain in upper arm; was very hard to lift arm.  Saturday the rash left and begun a runny nose with sneezing.  Talked with Drs. office on Thursday 04/25/2019 described what was going on, she was to leave Dr. a message.
Sex: M
Vaccine: HEP, UNK
Symptoms: Dyspnoea, Urticaria, Wheezing
Clinical narrative: Hives all over entire body and he started wheezing. He immediately developed breathing problems and has continuously gotten hives all over his body since.
Age: 20.0
Sex: M
Vaccine: TDAP
Symptoms: Blood pressure decreased, Gaze palsy, Heart rate decreased, Pallor, Unresponsive to stimuli
Clinical narrative: About 5-10 minutes after receiving Tdap vaccination, patient leaned forward in chair, became pale, unresponsive, and eyes deviated to the left.  The episode was witnessed by the clinician.  The episode lasted about 5-10 seconds.  The patient was not injured.  The patient's heart rate and blood pressure dropped, his SpO2 remained 99-100%.  After about 5-10 seconds the patient became alert and oriented.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, IPV, PNC13, RV1
Symptoms: Body temperature increased, Crying, Decreased appetite, Injection site swelling, Rash
Clinical narrative: Swelling of thighs, crying for hours before Tylenol was give , loss of appetite, fever, rash on back, whimpering a little and death crying before Tylenol,  each time Tylenol was given and then it wore off the temperature was higher each time. I believe the doctors down there have no idea what they are doing when it comes to vaccines. They keep pushing Tylenol and it?s not helping. I made a detox bath after another appointment, bath given at 8:10pm today. Tylenol was give at 5:46 pm when fever of 100.4. Then again at 101 at 1/2am on 4/30/19 and then the last dose was when temp was 101.7 on 4/30/19 at 11:29pm.
Age: 35.0
Sex: M
Vaccine: MMR
Symptoms: Blood test normal, Deafness unilateral, Dizziness, Nausea, Tinnitus
Clinical narrative: Around 36 hours after the vaccine was administered, I began to suffer from: Hearing loss in right ear, a constant "whooshing" sound in the right ear, and symptoms of vertigo - dizzyness, nausea, vomiting etc. It has been about ten days thus far, with no noticeable improvement.
Age: 35.0
Sex: M
Vaccine: MMR
Symptoms: Vertigo, Vomiting
Clinical narrative: Around 36 hours after the vaccine was administered, I began to suffer from: Hearing loss in right ear, a constant "whooshing" sound in the right ear, and symptoms of vertigo - dizzyness, nausea, vomiting etc. It has been about ten days thus far, with no noticeable improvement.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Injection site pain
Clinical narrative: Headache, chills, fatigue, moderate pain at the site.  Pain lasted 4 days. I am well tolerant to medication.  Never had this type of reaction. This was experienced at the first shot also.  My wife experienced the same symptoms on the dame day with the same vaccine.  TOOK Ibuprofen, no other medication
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Rash
Clinical narrative: Developed rash all over upper body Tylenol prn, Fluid. Pediatrician appt 5/1/19
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Borrelia test negative, Facial paralysis, Facial paresis
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 715105) on 31-JAN-2018. Received GARDASIL 9 (second dose) 11-SEP-2017 and the next day developed right Bell's palsy. Almost resolved by 20-SEP-2017.  Lab data Lyme disease antibody - neg  Other Medications  None Current Illnesses None History  None Prior Vaccinations Follow-up information was received from the vaccine provider on request by the Company from the FDA under the Freedom of Information Act (VAERS # 715105) on 25-FEB-2019. The patient did not receive any other vaccinations within 4 weeks of date of vaccination with the GARDASIL 9. Additionally, patient's vaccination place details were provided. Follow-up information was received from the physician, who was the vaccine provider, on 24-APR-2019. The patient's birth weight was 6lbs 7 ozs and had one brother. The patient had no illness at the time of vaccination, pre-existing physician-diagnosed allergies, birth defects and medical conditions or adverse events following previous vaccinations. On 11-SEP-2017 (also reported as 08-SEP-2017), the patient received her second dose of GARDASIL 9 intramuscularly, lot number reported as M03777 for prophylaxis previously reported as lot # M037770 (strength, dose, frequency and anatomical location were not provided). On 12-SEP-2017 (also reported as 10-SEP-2017), the next day after vaccination, the patient developed right facial Bell's Palsy (facial paralysis) described also as right facial weakness and the patient received prednisone as a treatment. On 20-SEP-2017, the facial paralysis resolved. On the same day, the patient mentioned that VAERS format was sent. At the time of the report, the patient was 14 year-old. The reporter considered the event facial paralysis as medically significant. Lot number M03777 is an invalid lot number for GARDASIL 9.
Age: 70.0
Sex: F
Vaccine: TTOX, VARZOS, VARZOS
Symptoms: Fatigue, Headache, Musculoskeletal stiffness, Myalgia, Neck pain
Clinical narrative: Patient came in with complaint of numbness tingling and swelling since the injection. She stated that she's unable to sleep on her left side and that the pain radiates form her neck to her fingers.
Age: 70.0
Sex: F
Vaccine: TTOX, VARZOS, VARZOS
Symptoms: Pain in extremity
Clinical narrative: Patient came in with complaint of numbness tingling and swelling since the injection. She stated that she's unable to sleep on her left side and that the pain radiates form her neck to her fingers.
Age: 70.0
Sex: F
Vaccine: TTOX, VARZOS, VARZOS
Symptoms: Hypoaesthesia, Insomnia, Neck pain, Pain, Pain in extremity
Clinical narrative: Patient came in with complaint of numbness tingling and swelling since the injection. She stated that she's unable to sleep on her left side and that the pain radiates form her neck to her fingers.
Age: 70.0
Sex: F
Vaccine: TTOX, VARZOS, VARZOS
Symptoms: Paraesthesia, Swelling
Clinical narrative: Patient came in with complaint of numbness tingling and swelling since the injection. She stated that she's unable to sleep on her left side and that the pain radiates form her neck to her fingers.
Age: 2.0
Sex: M
Vaccine: MMR
Symptoms: Haemophilus test positive, Measles antibody, Parvovirus B19 test negative, Pyrexia, Rash
Clinical narrative: Within hours of receiving the vaccination, began to develop rash on torso. By the first morning, the rash covered right cheek, neck, and progressed on torso. By the second morning, the rash covered both cheeks, progressed on torso, and began spreading on arms, and tops of hands and feet. By the third morning, the rash spread to legs and progressed on previously afflicted areas. The rash appeared identical to photos found on internet  of documented cases of measles and of documented reactions to MMR. Throughout this time, patient had a low grade fever and at one point a fever of 100.5. After three days of progression, the rash begin to show signs of improvement on 4/26 and was entirely gone by 4/30.
Age: 2.0
Sex: F
Vaccine: MMR
Symptoms: Abdominal pain, Antinuclear antibody negative, Arthralgia, Asthenia, Back pain
Clinical narrative: On 9/17/15, patient presented with a four-month history of knee pain, inability to climb, fatigue, and back pain. Myalgias continued, and extensive laboratory tests were run. Orthopedic consultation was obtained, and X-rays were normal and MRI was normal. On 1/26/16, patient presented with weakness of the right lower extremity and 3-week history of abdominal pain with melena. On 2/3/16, patient presented with a viral illness accompanied by high fevers and weakness. Since that time, patient has had recurrent joint aches (feet, knees) and neck pain when she awakens (causing her to get out of bed slowly).
Age: 2.0
Sex: F
Vaccine: MMR
Symptoms: Blood creatine phosphokinase normal, C-reactive protein normal, Fatigue, Full blood count normal, HLA-B*27 assay
Clinical narrative: On 9/17/15, patient presented with a four-month history of knee pain, inability to climb, fatigue, and back pain. Myalgias continued, and extensive laboratory tests were run. Orthopedic consultation was obtained, and X-rays were normal and MRI was normal. On 1/26/16, patient presented with weakness of the right lower extremity and 3-week history of abdominal pain with melena. On 2/3/16, patient presented with a viral illness accompanied by high fevers and weakness. Since that time, patient has had recurrent joint aches (feet, knees) and neck pain when she awakens (causing her to get out of bed slowly).
Age: 2.0
Sex: F
Vaccine: MMR
Symptoms: Melaena, Metabolic function test normal, Mobility decreased, Muscular weakness, Myalgia
Clinical narrative: On 9/17/15, patient presented with a four-month history of knee pain, inability to climb, fatigue, and back pain. Myalgias continued, and extensive laboratory tests were run. Orthopedic consultation was obtained, and X-rays were normal and MRI was normal. On 1/26/16, patient presented with weakness of the right lower extremity and 3-week history of abdominal pain with melena. On 2/3/16, patient presented with a viral illness accompanied by high fevers and weakness. Since that time, patient has had recurrent joint aches (feet, knees) and neck pain when she awakens (causing her to get out of bed slowly).
Age: 2.0
Sex: F
Vaccine: MMR
Symptoms: Neck pain, Nuclear magnetic resonance imaging normal, Pyrexia, Red blood cell sedimentation rate normal, Rheumatoid factor negative
Clinical narrative: On 9/17/15, patient presented with a four-month history of knee pain, inability to climb, fatigue, and back pain. Myalgias continued, and extensive laboratory tests were run. Orthopedic consultation was obtained, and X-rays were normal and MRI was normal. On 1/26/16, patient presented with weakness of the right lower extremity and 3-week history of abdominal pain with melena. On 2/3/16, patient presented with a viral illness accompanied by high fevers and weakness. Since that time, patient has had recurrent joint aches (feet, knees) and neck pain when she awakens (causing her to get out of bed slowly).
Age: 2.0
Sex: F
Vaccine: MMR
Symptoms: Viral infection, X-ray limb normal, X-ray of pelvis and hip normal
Clinical narrative: On 9/17/15, patient presented with a four-month history of knee pain, inability to climb, fatigue, and back pain. Myalgias continued, and extensive laboratory tests were run. Orthopedic consultation was obtained, and X-rays were normal and MRI was normal. On 1/26/16, patient presented with weakness of the right lower extremity and 3-week history of abdominal pain with melena. On 2/3/16, patient presented with a viral illness accompanied by high fevers and weakness. Since that time, patient has had recurrent joint aches (feet, knees) and neck pain when she awakens (causing her to get out of bed slowly).
Age: 1.33
Sex: F
Vaccine: MMR, PPV
Symptoms: Injection site erythema, Injection site infection, Injection site swelling, Injection site urticaria, Injection site warmth
Clinical narrative: The night of the vaccinations, the site was extremely swollen and red.  By the following evening it had turned warm to the touch and had what looked like hives. The redness had also spread. I took her to the ER where the doctor concluded she had an infection at her vaccination injection site.
Age: 1.0
Sex: F
Vaccine: FLU4, MMRV, PNC13
Symptoms: Condition aggravated, Crying, Diarrhoea, Feeling abnormal, Lethargy
Clinical narrative: Lethargic, staring away and not looking at us, extended stare and dazed.  Then extremely fussy, crying hard.  Developed rash and spiked a fever over 105 degrees.  Diarrhea. And sick overall.  Had to rush to the ER as she wouldn't look at us and spiked a fever over 105.  Months to follow initial reaction, continued to get sick with respiratory infections and more
Age: 1.0
Sex: F
Vaccine: FLU4, MMRV, PNC13
Symptoms: Malaise, Pyrexia, Rash, Respiratory tract infection, Staring
Clinical narrative: Lethargic, staring away and not looking at us, extended stare and dazed.  Then extremely fussy, crying hard.  Developed rash and spiked a fever over 105 degrees.  Diarrhea. And sick overall.  Had to rush to the ER as she wouldn't look at us and spiked a fever over 105.  Months to follow initial reaction, continued to get sick with respiratory infections and more
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Influenza, Pneumonia
Clinical narrative: One week after receiving injection I developed the flu and now I'm being treated for pneumonia.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Seven patients were administered an improperly stored dose of VARIVAX; No adverse effects were reported; This spontaneous report was received from a Registered Nurse concerning to a patient of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided.  On an unknown date, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) (dose was not reported) lot # N034557, the expiration date: 05-DEC-2019, subcutaneous for prophylaxis.  The sterile diluent was properly stored. No adverse effects were reported.  The temperature of excursion registered was 5.5 °F, for 2 hours and 15 minutes. The call was made due to a data logger and there was no previous temperature excursion.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1904USA013413: US-009507513-1904USA013414: US-009507513-1904USA013415: US-009507513-1904USA013416: US-009507513-1904USA013417: US-009507513-1904USA013418:
Sex: U
Vaccine: VARCEL, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: multiple unspecified patients were vaccinated with improperly stored VARIVAX; No adverse effects reported.; This spontaneous report was received from a nurse, concerning unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported.   On an unknown date, unspecified patients were vaccinated with improperly stored doses of varicella virus vaccine live (oka/merck) (VARIVAX) lot # N021318 and lot # R009409 (strength, dose, route of administration, and anatomical location were not reported) both for prophylaxis; which were previously reconstituted with a properly stored sterile diluent (MERCK STERILE DILUENT). No adverse effects reported.  Regarding varicella virus vaccine live (oka/merck) (VARIVAX) temperature excursions: The lot # N021318 with an expiration date on 07-AUG-2019 had a storage temperature from -9 to 8 degrees Celsius (°C) (-8 C) for a total time frame of 1 hour 20minutes. There was a previous temperature excursion at -50 °C to -15 °C (-14.7C) for 1 hour 15 minutes and -14 C to -10 C (-9.8 C) for y hours 45 minutes. The call was placed because of a Digital Data logger report.  The lot # R009409 with an expiration date on 29-MAR-2020 had a storage temperature from -9 C to 8 C (-8 C) for a total time frame of 1 hour 20 minutes. There was a previous temperature excursion at -50 °C to -15 °C (-14.7 C) for 1 hour 15 minutes. The call was placed because of a Digital Data logger report.
Age: 25.0
Sex: F
Vaccine: HPV9
Symptoms: Adenocarcinoma of the cervix, Cervix carcinoma, Colonoscopy, Human papilloma virus test positive, Hysterectomy
Clinical narrative: Information has been received from a 37 years old non pregnant female patient, referring to herself. The patient's concomitant medications included ethinyl estradiol, etonogestrel (NUVARING) and levonorgestrel (MIRENA). The patient did not have pertinent medical history, drug reactions or allergies. Additionally, it was mentioned that she had plantar warts at the time of vaccination.  On an unknown date in 2006 (reported as "early 2006"), the patient was vaccinated with the first dose of GARDASIL 9 administered as "injection" for prevention of Human Papilloma Virus (HPV) (strength, dose, anatomical injection site, lot number and expiration date were not reported). The patient received the second and third doses on month 2 and month 6 followed the first vaccine administered. It was reported that her plantar warts had disappeared since on an unknown date in 2006 (reported as "since receiving GARDASIL 9) (therapeutic response unexpected). On 07-DEC-2018, the patient was diagnosed with "HPV 18 and 45, but negative for HPV 16" (papilloma viral infection) and on 01-FEB-2019, she was diagnosed with cervical cancer, specifically "endocervical adenocarcinoma" (adenocarcinoma of the cervix). The patient sought for medical attention with an Obstetrics and Gynecology (OBGYN) and she  was hospitalized for one night at a medical center on an unknown date in 2019 for an hysterectomy, as treatment for this event. A colonoscopy was performed to the patient on an unknown date, but the results were not provided. At the time of the report, the patient had recovered from the adenocarcinoma of the cervix, the outcome of the patient regarding the papilloma viral infection was unknown, and the causality assessment between GARDASIL 9 and the aforementioned adverse events was not reported. Upon internal review, adenocarcinoma of the cervix was determined to be a medically significant event.
Age: 25.0
Sex: F
Vaccine: HPV9
Symptoms: Papilloma viral infection, Therapeutic response unexpected
Clinical narrative: Information has been received from a 37 years old non pregnant female patient, referring to herself. The patient's concomitant medications included ethinyl estradiol, etonogestrel (NUVARING) and levonorgestrel (MIRENA). The patient did not have pertinent medical history, drug reactions or allergies. Additionally, it was mentioned that she had plantar warts at the time of vaccination.  On an unknown date in 2006 (reported as "early 2006"), the patient was vaccinated with the first dose of GARDASIL 9 administered as "injection" for prevention of Human Papilloma Virus (HPV) (strength, dose, anatomical injection site, lot number and expiration date were not reported). The patient received the second and third doses on month 2 and month 6 followed the first vaccine administered. It was reported that her plantar warts had disappeared since on an unknown date in 2006 (reported as "since receiving GARDASIL 9) (therapeutic response unexpected). On 07-DEC-2018, the patient was diagnosed with "HPV 18 and 45, but negative for HPV 16" (papilloma viral infection) and on 01-FEB-2019, she was diagnosed with cervical cancer, specifically "endocervical adenocarcinoma" (adenocarcinoma of the cervix). The patient sought for medical attention with an Obstetrics and Gynecology (OBGYN) and she  was hospitalized for one night at a medical center on an unknown date in 2019 for an hysterectomy, as treatment for this event. A colonoscopy was performed to the patient on an unknown date, but the results were not provided. At the time of the report, the patient had recovered from the adenocarcinoma of the cervix, the outcome of the patient regarding the papilloma viral infection was unknown, and the causality assessment between GARDASIL 9 and the aforementioned adverse events was not reported. Upon internal review, adenocarcinoma of the cervix was determined to be a medically significant event.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse effects were reported.; the patient was administered the first dose in the GARDASIL 9 series "on an unknown date 3 years ago." / patient was administered the second dose in the GARDASIL 9 series 2 years later; This spontaneous report was received from a medical assistant regarding a 22-year-old patient of unknown gender. There was no information reported about the patient's concomitant medication, pertinent medical history and drug reactions/allergies.   On an unspecified date in 2016 (reported as: "on an unknown date 3 years ago"), the patient received the first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (route, anatomical site, lot number and expiration date not provided) for prophylaxis. Then, on 18-JUL-2018 (conflicting information, also reported as: "2 years later") the patient received the second dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (lot number N021571, expiration date 29-APR-2020) intramuscularly in right deltoid for prophylaxis (inappropriate schedule of product administration). No adverse effects were reported.
Sex: F
Vaccine: RV5
Symptoms: Exposure via eye contact, Product packaging issue
Clinical narrative: There was a hole in the oral dosing tubeProduct packaging issue; ROTATEQ squirt into her eye; This spontaneous report was received from a medical assistant concerning a female patient of unknown age. The patient's concurrent conditions and medical history, as well as concomitant medications, were not reported.  On 29-APR-2019, the patient's child was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # R028189, expiration date 06-JUN-2020 but, because there was a hole in the oral dosing tube (product packaging issue), the vaccine squirt into the patient's eye.  The reporter stated that the patient recovered from product packaging issue on 29-APR-2019.  The causality between product packaging issue and vaccine, live, oral, pentavalent (ROTATEQ) was unknown.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Seven patients were administered an improperly stored dose of VARIVAX; No adverse effects were reported; This spontaneous report was received from a Registered Nurse concerning to a patient of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided.  On an unknown date, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) (dose was not reported) lot # N034557, the expiration date: 05-DEC-2019, subcutaneous for prophylaxis.  The sterile diluent was properly stored. No adverse effects were reported.  The temperature of excursion registered was 5.5 °F, for 2 hours and 15 minutes. The call was made due to a data logger and there was no previous temperature excursion.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1904USA008023:
Sex: M
Vaccine: MENB
Symptoms: Injection site pain
Clinical narrative: vaccination site pain; This case was reported by a physician via sales rep and described the occurrence of injection site pain in a male patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received Bexsero at an unknown dose. On an unknown date, unknown after receiving Bexsero, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site pain to be related to Bexsero.  Additional details were provided as follows: The age at vaccination was not report. The reporter mentioned that the patient did not experienced any adverse events with Bexsero other than that the patient experienced pain at injection site.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site erythema, Injection site swelling, Injection site warmth, Peripheral swelling
Clinical narrative: Hot to the touch; Swelling; Redness at injection site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 70-year-old female patient who received Herpes zoster (Shingrix) (batch number 7X3EJ, expiry date 13th October 2020) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain (for tolerance of 1st dose refer case US2019072370).   On 19th April 2019, the patient received the 2nd dose of Shingrix. In April 2019, less than a week after receiving Shingrix, the patient experienced injection site erythema, feeling of warmth and swelling. On an unknown date, the outcome of the injection site erythema, feeling of warmth and swelling were unknown.   It was unknown if the reporter considered the injection site erythema, feeling of warmth and swelling to be related to Shingrix.  Additional details were provided as follows: The pharmacist reported that a patient notes her arm is swollen, red and hot to the touch after 2nd dose of Shingrix series.   The health care professional described swollen as a red circle about the size of a grapefruit. Exact start dates for events were not provided. No outcomes and outcome dates of events were provided.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin warm
Clinical narrative: Hot to the touch; Swelling; Redness at injection site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 70-year-old female patient who received Herpes zoster (Shingrix) (batch number 7X3EJ, expiry date 13th October 2020) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain (for tolerance of 1st dose refer case US2019072370).   On 19th April 2019, the patient received the 2nd dose of Shingrix. In April 2019, less than a week after receiving Shingrix, the patient experienced injection site erythema, feeling of warmth and swelling. On an unknown date, the outcome of the injection site erythema, feeling of warmth and swelling were unknown.   It was unknown if the reporter considered the injection site erythema, feeling of warmth and swelling to be related to Shingrix.  Additional details were provided as follows: The pharmacist reported that a patient notes her arm is swollen, red and hot to the touch after 2nd dose of Shingrix series.   The health care professional described swollen as a red circle about the size of a grapefruit. Exact start dates for events were not provided. No outcomes and outcome dates of events were provided.
Sex: F
Vaccine: MENB
Symptoms: Pain in extremity
Clinical narrative: Arm pain; This case was reported by a physician via call center representative and described the occurrence of pain in arm in a female patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received Bexsero at an unknown dose. On an unknown date, unknown after receiving Bexsero, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The age of patient was reported as above 16 years old. The patient experienced arm pain after receiving the vaccine. The reporter stated she does not have further details available at the time of the call. This case was 1 of the 3 linked cases, reported by same reporter.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site discomfort, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: generalized itching; itching at injection site; redness at injection site; swelling at injection site; hardness at injection site; flu like symptoms; discomfort at injection site; pain at injection site; This case was reported by a nurse via call center representative and described the occurrence of generalized pruritus in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingles vaccine (received 2 to 3 years ago from the date of reporting).   On 26th February 2019, the patient received the 1st dose of Shingrix (intramuscular). On 27th February 2019, 1 days after receiving Shingrix, the patient experienced injection site discomfort, injection site pain and influenza-like symptoms. On an unknown date, the patient experienced generalized pruritus, injection site itching, injection site erythema, injection site swelling and injection site induration. On an unknown date, the outcome of the generalized pruritus, injection site itching, injection site discomfort, injection site pain, injection site erythema, injection site swelling, injection site induration and influenza-like symptoms were recovered/resolved.   It was unknown if the reporter considered the generalized pruritus, injection site itching, injection site discomfort, injection site pain, injection site erythema, injection site swelling, injection site induration and influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix on left arm. The day after receiving the Shingrix, she developed flu like symptoms, and discomfort and pain at the injection site. Less than a year after receiving Shingrix, the patient also developed redness, swelling and hardness at the injection site. The patient stated that the redness looked like streaks. The patient also developed generalized itching, all over, but especially at the injection site. The reporter consented to follow up. In core outcome of the events generalized pruritus, injection site itching, injection site discomfort, injection site pain, injection site erythema, injection site swelling, injection site induration and influenza-like symptoms were recovered/resolved, however in source document the outcome of this events were reported as recovered/resolved with sequel.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site swelling, Pruritus generalised
Clinical narrative: generalized itching; itching at injection site; redness at injection site; swelling at injection site; hardness at injection site; flu like symptoms; discomfort at injection site; pain at injection site; This case was reported by a nurse via call center representative and described the occurrence of generalized pruritus in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingles vaccine (received 2 to 3 years ago from the date of reporting).   On 26th February 2019, the patient received the 1st dose of Shingrix (intramuscular). On 27th February 2019, 1 days after receiving Shingrix, the patient experienced injection site discomfort, injection site pain and influenza-like symptoms. On an unknown date, the patient experienced generalized pruritus, injection site itching, injection site erythema, injection site swelling and injection site induration. On an unknown date, the outcome of the generalized pruritus, injection site itching, injection site discomfort, injection site pain, injection site erythema, injection site swelling, injection site induration and influenza-like symptoms were recovered/resolved.   It was unknown if the reporter considered the generalized pruritus, injection site itching, injection site discomfort, injection site pain, injection site erythema, injection site swelling, injection site induration and influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix on left arm. The day after receiving the Shingrix, she developed flu like symptoms, and discomfort and pain at the injection site. Less than a year after receiving Shingrix, the patient also developed redness, swelling and hardness at the injection site. The patient stated that the redness looked like streaks. The patient also developed generalized itching, all over, but especially at the injection site. The reporter consented to follow up. In core outcome of the events generalized pruritus, injection site itching, injection site discomfort, injection site pain, injection site erythema, injection site swelling, injection site induration and influenza-like symptoms were recovered/resolved, however in source document the outcome of this events were reported as recovered/resolved with sequel.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Extensive swelling of vaccinated limb, Eye irritation, Flushing, Gastritis, Injection site erythema
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 79-year-old female patient who received SHINGRIX (batch number BF4J5, expiry date 5th July 2021) for prophylaxis. Concomitant products included steroids nos (Steroids). On 2nd March 2019, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In March 2019, 1 day after receiving SHINGRIX, the patient experienced extensive swelling of vaccinated limb (serious criteria other: ER visit), injection site erythema (serious criteria hospitalization), injection site itching (serious criteria hospitalization), burning tongue (serious criteria hospitalization), burning in eyes (serious criteria hospitalization), facial flushing (serious criteria hospitalization) and gastritis (serious criteria hospitalization). The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the extensive swelling of vaccinated limb, injection site erythema, injection site itching, burning tongue, burning in eyes, facial flushing and gastritis were not recovered/not resolved. It was unknown if the reporter considered the extensive swelling of vaccinated limb, injection site erythema, injection site itching, burning tongue, burning in eyes, facial flushing and gastritis to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on the left arm. One to 2 days after vaccination, the patient experienced all the symptoms. The patient experienced redness, swelling (extensive swelling of vaccinated limb), and itching approximately 5 inches in diameter on the skin around the injection site. The patient also experienced slight burning on tongue, burning on both eyes and flushing on face on both cheeks and over nose. The patient received Tylenol daily post-vaccination to suppress symptoms. The patient also received icing for injection site relief. The patient also experienced severe episode of gastritis which required emergency visit approximately 2 weeks after vaccination. The reporter stated she, primary care physician and registered pharmacist unsure if she should receive 2nd dose. The reporter consented to follow up.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Tongue discomfort
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 79-year-old female patient who received SHINGRIX (batch number BF4J5, expiry date 5th July 2021) for prophylaxis. Concomitant products included steroids nos (Steroids). On 2nd March 2019, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In March 2019, 1 day after receiving SHINGRIX, the patient experienced extensive swelling of vaccinated limb (serious criteria other: ER visit), injection site erythema (serious criteria hospitalization), injection site itching (serious criteria hospitalization), burning tongue (serious criteria hospitalization), burning in eyes (serious criteria hospitalization), facial flushing (serious criteria hospitalization) and gastritis (serious criteria hospitalization). The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the extensive swelling of vaccinated limb, injection site erythema, injection site itching, burning tongue, burning in eyes, facial flushing and gastritis were not recovered/not resolved. It was unknown if the reporter considered the extensive swelling of vaccinated limb, injection site erythema, injection site itching, burning tongue, burning in eyes, facial flushing and gastritis to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on the left arm. One to 2 days after vaccination, the patient experienced all the symptoms. The patient experienced redness, swelling (extensive swelling of vaccinated limb), and itching approximately 5 inches in diameter on the skin around the injection site. The patient also experienced slight burning on tongue, burning on both eyes and flushing on face on both cheeks and over nose. The patient received Tylenol daily post-vaccination to suppress symptoms. The patient also received icing for injection site relief. The patient also experienced severe episode of gastritis which required emergency visit approximately 2 weeks after vaccination. The reporter stated she, primary care physician and registered pharmacist unsure if she should receive 2nd dose. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: rash; This case was reported by a pharmacist via call center representative and described the occurrence of rash 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 rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per vaccine indication. The pharmacist stated that other pharmacists had told her patient's had gotten a rash after getting a Shingrix vaccination. The pharmacist was unable to provide further details at time of reporting.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Soreness; This case was reported by a pharmacist via call center representative and described the occurrence of pain in a 69-year-old female patient who received Herpes zoster (Shingrix) (batch number ZG47A, expiry date 12th December 2021) for prophylaxis.   On 16th January 2019, the patient received the 1st dose of Shingrix. On 17th January 2019, 1 days after receiving Shingrix, the patient experienced pain. On an unknown date, the outcome of the pain was recovered/resolved.   It was unknown if the reporter considered the pain to be related to Shingrix.  Additional details were provided as follows: The patient noted soreness the next day after 1st dose of Shingrix.  The case has been linked with case US2019GSK077043, reported by same reporter for same patient.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in a 75-year-old female patient who received SHINGRIX (batch number L7SY9, expiry date 4th July 2021) for prophylaxis. On 28th March 2019, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 28th March 2019, less than a day after receiving SHINGRIX, the patient experienced injection site swelling (serious criteria clinically significant/intervention required), injection site pain (serious criteria clinically significant/intervention required) and injection site itching (serious criteria clinically significant/intervention required). The patient was treated with TYLENOL and medication unknown (Ice Pack (Nos)). On 3rd April 2019, the outcome of the injection site swelling, injection site pain and injection site itching were recovered/resolved. It was unknown if the reporter considered the injection site swelling, injection site pain and injection site itching to be related to SHINGRIX. Additional details were provoded as follows: The patient experienced injection site soreness, itching, and swelling (3 inch diameter) that started on the day of administration. The healtcare profession (HCP) reported that the patient treated herself with TYLENOL and ice and the symptoms were resolved on 3rd April 2019. The HCP consent to follow up.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood test, Diarrhoea, Influenza like illness, Rash
Clinical narrative: one day after flu like symptoms that lasted 2 day-on the 3rd day severe diarrehea for 2 days-then the next day body rash-mostley upper torso
Age: 1.25
Sex: F
Vaccine: DTAPHEPBIP, FLU4, HEPA, MMRV
Symptoms: Blood test, Injection site erythema, Injection site pain, Patient isolation, Pyrexia
Clinical narrative: red/painful at the injection sights.  Within 24 hours, her body from head to toe broke out in a measles like rash and she started having a fever of 103.  I took her to the hospital and she was given an iv with .9 saline.  Discharged home.  The next day, I took her to the doctor office.  Dr said it looked like hives and sent her to the emergency room.  ER gave her an antihistamine and more IV fluids.  Sent her home.  The day following, I took her back to the doctor's office.  They sent her to the ER again.  This time, they gave her steroids and fluids IV.  They couldn't determine if it was measles or not, so they sent her to another hospital via ambulance.   She was admitted to the pediatric unit and put in quarantine.  They wanted an infectious control doctor to rule out measles.   She received a lot of steroids and was on an IV for days.  They documented that she did not have an outbreak of measles but that she had a "virus" prior to receiving the MMR and it caused a rash resembling measles.  Staff still continued to gown up to enter the room she was in.
Age: 1.25
Sex: F
Vaccine: DTAPHEPBIP, FLU4, HEPA, MMRV
Symptoms: Rash generalised, Rash morbilliform, Urticaria
Clinical narrative: red/painful at the injection sights.  Within 24 hours, her body from head to toe broke out in a measles like rash and she started having a fever of 103.  I took her to the hospital and she was given an iv with .9 saline.  Discharged home.  The next day, I took her to the doctor office.  Dr said it looked like hives and sent her to the emergency room.  ER gave her an antihistamine and more IV fluids.  Sent her home.  The day following, I took her back to the doctor's office.  They sent her to the ER again.  This time, they gave her steroids and fluids IV.  They couldn't determine if it was measles or not, so they sent her to another hospital via ambulance.   She was admitted to the pediatric unit and put in quarantine.  They wanted an infectious control doctor to rule out measles.   She received a lot of steroids and was on an IV for days.  They documented that she did not have an outbreak of measles but that she had a "virus" prior to receiving the MMR and it caused a rash resembling measles.  Staff still continued to gown up to enter the room she was in.
Age: 27.0
Sex: M
Vaccine: FLU4
Symptoms: Asthenia, Dizziness, Nausea
Clinical narrative: Had flu shot and about 2 to 3 hrs later he had onset of nausea, lightheadedness, and weakness. Was seen in urgent care clinic and given 2 lites of NS and zofran. Patient then felt better overnight but came back to urgent care the next morning. Reported symptons of weakness, nausea, and lightheadedness which became more severe with time.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Computerised tomogram head normal, Condition aggravated, Seizure
Clinical narrative: Pt received Men B#2 on 4/26/19. Has 3 seizures with 24 hours of dosing was dx with seizures about 8 mo ago and having them q 7-10 d but significant increase in freq post second shot. Had Neg CT, Neg Shunt Series.
Age: 23.0
Sex: F
Vaccine: JEV1
Symptoms: Dizziness
Clinical narrative: lightheadedness
Age: 46.0
Sex: M
Vaccine: MNQ, PPV
Symptoms: Syncope, White blood cell count increased
Clinical narrative: syncope and collapse
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Expired product administered, No adverse event
Clinical narrative: Gave the vaccine one day after it expired. No issues with the patient.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site cellulitis, Injection site inflammation, Pain, Pyrexia
Clinical narrative: Pain , low grade temp and inflammation of L upper arm ,,  about  1/3 of  L upper arm involved,  appears to be cellulitis
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Decreased appetite, Fatigue, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pain, redness/localized swelling at site. Fatigue, poor appetite. Advised to take Aleve or OTC pain meds, ice the area. Advised to call if symptoms worsen.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Influenza like illness, Myalgia
Clinical narrative: Flu like symptoms:  muscle aches, extreme fatigue, slight headache
Age: 70.0
Sex: M
Vaccine: IPV
Symptoms: Wrong product administered
Clinical narrative: Grab wrong vaccine IPV when suppose to administer TB skin test.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: No adverse event
Clinical narrative: no adverse event to injection, no treatment needed.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Formication, Injection site erythema, Injection site swelling
Clinical narrative: Started off as not on upper arm the night of immunization, patient then experienced the feeling of "bugs" crawling on the arm. She started taking antihistamine. Tuesday arm was completely red and swollen above the elbow on left arm. She took Benadryl, aspirin and Zyrtec and then went to primary care office and received a steroid shot.  Patient stated that she is missing lymph nodes on that side off body.  Wednesday the arm was improving, not as tight and redness slowly going away.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Chest X-ray abnormal, Chills, Cough, Dyspnoea, Influenza virus test negative
Clinical narrative: 4-11-19 PT RECEIVED PNEUMOVAX 23, BY 4-13-19 PT WAS HAVING INCREASED DIFFICULTY BREATHING, CHILLS, ACHY, AND COUGH. PT WAS ORDERED CHEST XRAY AND WAS POSITIVE FOR MIDDLE LOBE PNEUMONIA. SHE WAS TREATED WITH LEVAQUIN 750MG DAILYX5 DAYS AND PREDNISONE 20MG TWICE DAILYX5 DAYS AND FOLLOW UP WITH PCP.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Lung infiltration, Pain, Pneumonia
Clinical narrative: 4-11-19 PT RECEIVED PNEUMOVAX 23, BY 4-13-19 PT WAS HAVING INCREASED DIFFICULTY BREATHING, CHILLS, ACHY, AND COUGH. PT WAS ORDERED CHEST XRAY AND WAS POSITIVE FOR MIDDLE LOBE PNEUMONIA. SHE WAS TREATED WITH LEVAQUIN 750MG DAILYX5 DAYS AND PREDNISONE 20MG TWICE DAILYX5 DAYS AND FOLLOW UP WITH PCP.
Age: 70.0
Sex: F
Vaccine: UNK, VARZOS
Symptoms: Erythema, Induration
Clinical narrative: ON APRIL 10, THE PATIENT RECEIVED A SHINGRIX VACCINE. TWO DAYS AFTER THE PATIENT RECEIVED THE VACCINE, SHE EXPERIENCED A HARD, RED SPOT AROUND 3-4 INCHES IN DIAMETER SEVERAL INCHES DOWN FROM THE INJECTION SITE.  SHE DID NOT SEEK TREATMENT, AND THE SPOT DISAPPEARED AROUND 10 DAYS LATER. THE PATIENT DID NOT REPORT THIS TO THE PHARMACY UNTIL APRIL 29, 2019
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Impaired work ability, Influenza like illness, Injection site pain
Clinical narrative: Patient called the morning after her vaccine stating she had very tender arm around injection site, chills, headache, body aches, and she vomited.   She had to leave work after an hour to go home and rest.  She stated it feels like she has the flu.  It was recommended that she use an analgesic such as acetaminophen to help with the achy feeling.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Vomiting
Clinical narrative: Patient called the morning after her vaccine stating she had very tender arm around injection site, chills, headache, body aches, and she vomited.   She had to leave work after an hour to go home and rest.  She stated it feels like she has the flu.  It was recommended that she use an analgesic such as acetaminophen to help with the achy feeling.