chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: soreness at injection site; This case was reported by a physician via call center representative and described the occurrence of injection site pain in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, 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 Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The patient experienced soreness at injection site after receiving 1st dose of vaccine. The reporter consented to follow up. For tolerance of 2nd dose, refer case US2020107123.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020107123:same reporter
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Extra dose administered
Clinical narrative: Pt. Already Received the vaccines two months ago at the health department.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, HEPA
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: To Health Dept for school vaccinations- given 5th dose of DTaP and 4th dose of IPV (Quadracel) Right deltoid and also given Hep A Right deltoid. Had Proquad Left deltoid.  Gave family instructions: "After Shots Information from the site. 07/31/2020 Child brought into the health dept with concerns for Right upper arm redness/swelling approx 2cm circular area- no redness to the left upper arm noted- child had good range of motion does not complain of pain when area touched. Foster parents report, he was fine yesterday and noticed the redness and swelling when he woke up today; they brought the child in to the health dept. advised to call child's pediatrician- they do voice understanding that the redness/swelling can be a normal reaction after the DTaP and Polio vaccine. Nurse called to speak with child's physician's nurse- message left on nurse line-
Age: 58.0
Sex: F
Vaccine: PPV
Symptoms: Feeling hot, Injection site erythema, Swelling
Clinical narrative: REDNESS BELOW INJECTION SITE, SWELLING, HOT, NO FEVER
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Feeling hot, Injection site discolouration, Pain, Swelling
Clinical narrative: I was injected with pneumavara 23 on Sunday, July 26, 2020. I experienced the typical systems of a vaccine injection, swelling, heat, aches and took 1 Aleve OTC on Monday , July 27, 2020.  Wednesday, July 29, 2020 I noticed a yellow streak  about 4-5 inches below the  injection and about 7-8 long. It looked like a bruise that was healing but I had not banged my arm at all.
Age: 53.0
Sex: F
Vaccine: UNK
Symptoms: Chills, Headache, Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: Pain at the site of injection, shivering, headache, swelling and a hot red rash at the site of injection that became larger over next 4 days and completely disappeared after 6 days.
Age: 53.0
Sex: F
Vaccine: UNK
Symptoms: Injection site warmth, Rash erythematous
Clinical narrative: Pain at the site of injection, shivering, headache, swelling and a hot red rash at the site of injection that became larger over next 4 days and completely disappeared after 6 days.
Age: 16.0
Sex: M
Vaccine: HPV9, MENB, MNQ
Symptoms: Cold sweat, Dizziness, Loss of consciousness, Nervousness, Pallor
Clinical narrative: Passed out after administration of all vaccines, lasting about 15 seconds.  Patient clammy, pale in color and having difficulty focusing thoughts.  Patient was put in reclining position with his knees bent, feet flat on the table.  After 15 seconds he recovered, but was still feeling a little shaky.  Had patient sit up and drink some water.  After about 5 minutes, patient left with his father.
Age: 16.0
Sex: M
Vaccine: HPV9, MENB, MNQ
Symptoms: Thinking abnormal
Clinical narrative: Passed out after administration of all vaccines, lasting about 15 seconds.  Patient clammy, pale in color and having difficulty focusing thoughts.  Patient was put in reclining position with his knees bent, feet flat on the table.  After 15 seconds he recovered, but was still feeling a little shaky.  Had patient sit up and drink some water.  After about 5 minutes, patient left with his father.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: of redness, warmth, swelling, pain and itching of left thigh that started on 7/15/2020 after 2 IZs given.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Patient reported developing a low-grade temperature within an hour of vaccination followed by burning, moderate pain, and redness at the injection site.  On 07/27/2020, patient reported to pharmacy that there was mild/moderate swelling to the right deltoid region with redness extending to the right lateral elbow with some warmth.  Patient was encouraged to follow-up with her PCP that day to rule out a hyper immune response verses cellulitis.  In a follow-up call to the patient on 07/28/2020, the patient stated that some of the redness that had extended to the elbow had resolved, but there was still warmth/redness/mild-to-moderate pain at the injection site with some extension down the right arm.  She stated that she had called her PCP's office, but that she was not seen the previous day because he was not in the office that day.  Patient was encouraged again to follow-up with her PCP or another clinician in the office as soon as that opportunity was available.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site reaction, Rash, Rash erythematous, Rash pruritic
Clinical narrative: Red, bumpy rash on left side of chest and left shoulder. Rash is itchy - not painful or tingly. Appeared 48 hours after injection to left deltoid muscle. Has not completely resolved after 96 hours after injection. Continues to be itchy, but not painful or tingly. Left deltoid muscle is still sore 96 hours after injection. Patient did NOT experience flu-like symptoms (fever, malaise, etc).
Age: 17.0
Sex: M
Vaccine: HPV9
Symptoms: Appendicectomy, Appendicitis, Blood test, Computerised tomogram, Urine analysis
Clinical narrative: Appendicitis lead to an emergency appendectomy, which led to surgery.
Age: 1.08
Sex: M
Vaccine: HEPA, MMRV, PNC13
Symptoms: Rash
Clinical narrative: Diffuse rash
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effects reported; VARlVAX that was improperly stored was administered on 7/20/2020 to a patient; This spontaneous report was received from an office manager and refers to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were unknown.  On 20-JUL-2020, the patient was vaccinated with an improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) lot # S035126, expiration date 04-NOV-2021 (formulation, strength, exact dose and route of administration were not reported) for prophylaxis (product storage error). No adverse effects were reported. The temperature excursion was -11.8 degrees Celsius for 3 hours and 52 minutes. There was no previous temperature excursion recorded. A data logger was involved in recording the temperature.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: there had been administrations of the vaccines to patients since the first excursion; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, allergies, drug reactions, concomitant therapies or medical history provided. On 20-JUL-2020, the patient was vaccinated with a dose of improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (lot # S019463, expiration date: 24-JUN-2021) 0.5 milliliter (dose number, route of administration and anatomical location were not reported) for prophylaxis. The temperatures to which the vaccine was exposed were: -13.5 degrees of Celsius (C), -11.4 C, -1.8 C  and the time frame was reported as 24 minutes, 27 minutes, 2 hours and 8 minutes. There was previous temperature excursion reported. A digital data logger was involved.
Age: 30.0
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy, Wrong product administered
Clinical narrative: vaccine exposure during pregnancy; wrong vaccine administered; This spontaneous prospective pregnancy report concerning a 30 year old female patient who was reporting on herself. The patient's historical vaccines included completed series of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) when she was around 18 or 19 year old. The patient had no medical history, concurrent conditions, concomitant medications or drug reactions/allergies.  On the morning of 27-JUL-2020, the patient went to her physician's office to get vaccinated with Rho(D) immune globulin (RHOGAM) however her Doctor's office contacted her later in the afternoon to notify the patient they had inadvertently vaccinated her with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) for prophylaxis (dose, frequency, route of administration, anatomical location, lot number and expiration date were not provided) instead of the Rho(D) immune globulin (RHOGAM) shot she was intended to receive. Patient said she was concerned that she was administered the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) shot in error because she was 6 weeks pregnant at the reporting time.   On an unknown date, the patient became pregnant with last menstrual period (LMP) of 15-JUN-2020, and estimated date of delivery (EDD) of 22-MAR-2021. The pregnancy outcome was pending.
Sex: U
Vaccine: PPV, PPV
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No other adverse effects were reported in the patient; A patient received a dose of PNEUMOVAX23 on 4/22/2019 and a second dose on 2/8/2020; Information has been received from a pharmacist regarding a patient of unknown age and gender. The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medications were not reported.  On 22-APR-2019, the patient was vaccinated with the first dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, for prophylaxis, lot number R018732 with expiration date in 27-FEB-2020 (route of administration, strength and anatomical location were not reported) and on 08-FEB-2020, was received the second dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, for prophylaxis, lot number S026366 with expiration date in 17-SEP-2020 (route of administration, strength and anatomical location were not reported) (inappropriate schedule of vaccine administered).  No other adverse effects were reported in the patient. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; manufactureraddress:; manufacturercity:; manufacturerstate:; manufacturercountry:; devicelotnumber: R018732; expirationdate: 27-FEB-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Headache, Mobility decreased, Pain in extremity
Clinical narrative: feel terrible/ feel like I can hardly go; headache; legs are achy; feel like I can hardly go; This case was reported by a consumer and described the occurrence of feeling bad in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 21st July 2020, the patient received the 2nd dose of Shingles vaccine. In July 2020, less than a week after receiving Shingles vaccine, the patient experienced feeling bad, headache, leg pain and mobility decreased. On an unknown date, the outcome of the feeling bad, headache, leg pain and mobility decreased were unknown.   It was unknown if the reporter considered the feeling bad, headache, leg pain and mobility decreased to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient got second shingles shot yesterday, and patient was felt terrible,  legs were achy and headache. The patient felt like she could hardly go.  The patient had asked anybody else had any problems with it? The patient asked her if it was Shingrix, but the patient was not sure.
Sex: U
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: not feeling well; This case was reported by a consumer via interactive digital media and described the occurrence of feeling unwell in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd July 2020, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced feeling unwell. On an unknown date, the outcome of the feeling unwell was unknown.   It was unknown if the reporter considered the feeling unwell 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 the vaccine indication. The patient received Shingrix and had not feeling well.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, Injection site pain
Clinical narrative: soreness at injection site; has not yet received dose 2; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 83-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included cancer. Previously administered products included Shingrix (1st dose received a year before reporting). Concurrent medical conditions included diabetes.   On an unknown date, the patient received the 2nd dose of Shingrix (intramuscular). On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional information was provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter consented to follow up. Consumer did not have vaccine information for this adverse event.   Follow up information received from physician on 24th July 2020: The patient's demographic details were updated. The patient experienced soreness at injection site in less than 2 months after receiving 2nd dose of vaccine. The patient received 2nd dose later than the recommended interval, which led to lengthening of vaccination schedule. This case was linked with US2020AMR145722, reported for same patient for 1st dose.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR145722:same reporter
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash pruritic, Rash pustular, Rash vesicular
Clinical narrative: abdomen, upper extremities and head with multiple pustules; blister appearing spots/appears to be chicken pox; itch; This case was reported by a nurse via call center representative and described the occurrence of pustular rash in a 60-year-old female patient who received Herpes zoster (Shingrix) (batch number 557ZA, expiry date 1st December 2021) for prophylaxis.   On 13th July 2020, the patient received the 2nd dose of Shingrix. On 18th July 2020, 5 days after receiving Shingrix, the patient experienced pustular rash, blistery rash and itchy rash. On an unknown date, the outcome of the pustular rash, blistery rash and itchy rash were unknown.   It was unknown if the reporter considered the pustular rash, blistery rash and itchy rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported The nurse reported patient received  her second dose of Shingrix and she had broken out on her abdomen, upper extremities and head with multiple pustules, what appears to be chicken pox.  They just itch, and had blister appearing spots. It started over past weekend and each day more appeared. The reporter did not think it was shingles. The patient did not experienced fever, malaise or anything else other than these breakouts. The reporter consented to follow up. This case has been linked with the case US2020138148 and US2020AMR138449, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020138149:same reporter
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site haemorrhage, Injection site reaction, Wrong technique in product usage process
Clinical narrative: bubble on the skin and then a lot of blood upon removal of the needle; wrong technique in product usage process; This case was reported by a pharmacist via call center representative and described the occurrence of injection site hemorrhage in a 71-year-old female patient who received Herpes zoster (Shingrix) (batch number 454S2, expiry date 5th November 2021) for prophylaxis.   On 23rd July 2020, the patient received Shingrix (intramuscular). On 23rd July 2020, immediately after receiving Shingrix, the patient experienced injection site hemorrhage and wrong technique in product usage process. On an unknown date, the outcome of the injection site hemorrhage and wrong technique in product usage process were unknown.   The reporter considered the injection site hemorrhage to be related to Shingrix.  Additional details were reported as follows: The patient upon injection into the arm there was a lot of pressure behind the syringe and then after injected in the arm, it caused kind of bubble on the skin and then bleeding upon removal of the needle, which led to wrong technique in product usage process. The pharmacist stated that was sure the injection was intramuscularly. The reporter consented to follow up. This case linked with US2020140271, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020140271:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Injection site haemorrhage, Injection site reaction, Wrong technique in product usage process
Clinical narrative: bubble on the skin and then bleeding upon removal of the needle; wrong technique in product usage process; This case was reported by a pharmacist via call center representative and described the occurrence of injection site hemorrhage in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix (intramuscular). On an unknown date, immediately after receiving Shingrix, the patient experienced injection site hemorrhage and wrong technique in product usage process. On an unknown date, the outcome of the injection site hemorrhage and wrong technique in product usage process were unknown.   The reporter considered the injection site hemorrhage to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient upon injection into the arm there was a lot of pressure behind the syringe and then after injected in the arm, it caused kind of bubble on the skin and then bleeding upon removal of the needle, which led to wrong technique in product usage process. The pharmacist stated that was sure the injection was intramuscularly. The reporter consented to follow up. This case linked with US2020140254, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020140254:same reporter
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: break of Shingles; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In December 2018, the patient received the 1st dose of Shingrix. On 19th July 2020, less than 2 years after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were reported as follows: The patient received Shingrix and experienced a break of Shingles. The reporter consented to follow up.  The pharmacist did not had vaccine details on hand but agreed to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination, Social problem
Clinical narrative: due to Covid they didn't get yet the 2nd dose; This case was reported by a nurse via call center representative and described the occurrence of social problem in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in October 2019, from batch ZP3P9 with expiry date 10th September 2021).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.  Additional details were reported as follows: The age at vaccination was not applicable for this report. The patient got the 1st dose of Shingrix in October 2019 and due to covid she did not yet receive the 2nd dose. It had been already 9 months since 1st dose. No other information was provided. The reporter consented to follow up. The VAERS details were reported for 1st dose. The case is linked to case US2020144266, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020144266:same reporter
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Body temperature increased, Chills, Fatigue, Headache
Clinical narrative: HUGE headache for 3 days Sore and stiff muscles for 3 days 101 temperature, body chills and aches for 1 day upset stomach for 2 days tiredness for 3 days
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Musculoskeletal stiffness, Myalgia, Pain
Clinical narrative: HUGE headache for 3 days Sore and stiff muscles for 3 days 101 temperature, body chills and aches for 1 day upset stomach for 2 days tiredness for 3 days
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Erythema, Pain, Skin warm, Swelling
Clinical narrative: Localized redness, warmth, some swelling, pain
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Cellulitis, Injection site erythema, Injection site warmth, Pyrexia
Clinical narrative: Patient began with red area at injection site 8/24/20. Area grew, is warm to  touch + patient began with fever. Treated  today for cellulitis
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effects reported; a patient was administered an improperly stored dose of ROTATEQ; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. Information regarding the patient's concomitant therapies, concurrent conditions, medical history and historical drugs was not provided.  On 17-JUL-2020, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (dosage regimen was not reported) lot # S013890, expiration date 14-FEB-2021, administered as prophylaxis.       The improperly stored dose of the suspect vaccine experienced a  temperature excursion of 48.7 degrees Fahrenheit (°F) during 2 hours and 30 minutes with no previous temperature excursion. The call was made due to a digital data logger. No adverse symptoms were reported.
Age: 21.0
Sex: U
Vaccine: HPV4, HPV9
Symptoms: No adverse event, Product lot number issue
Clinical narrative: product lot number issue; no symptoms or additional adverse effects reported; second dose in GARDASIL 9 immunization series was administered to patient past its expiration date; This spontaneous report has been received from a medical assistant regarding a 21-years-old patient of unknown gender. The patient's concurrent conditions, historical conditions and concomitant medications were not reported.    On an unknown date, the patient was vaccinated with the first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (dose, frequency, route of administration, lot # and expiration date were not reported) as prophylaxis. On 24-JUL-2020, the patient was vaccinated in the immunization series with the second dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) 0.5 milliliter once (reporter reported of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) with Lot # N026814 which was not valid for of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9). However, lot # N026814 is valid for Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL), expiration date 15-JUL-2020) past its expiration date. No symptoms or additional adverse effects reported.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Herpes Zoster; This initial spontaneous information was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender.  On or about 21-NOV-2011, the patient was inoculated with zoster vaccine live (ZOSTAVAX) by a healthcare provider for the long-term prevention of shingles and/or zoster-related conditions. Subsequent to patient's zoster vaccine live (ZOSTAVAX) inoculation, the patient was treated by a healthcare provider for herpes zoster. As a direct and proximate result of patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, 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 the event was unknown. The event was considered to be related to zoster vaccine live (ZOSTAVAX).
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; The HCP had administered expired ROTATEQ; This spontaneous report was received from a pediatric nurse practitioner (PNP) concerning a patient of unknown age and gender. The patient's concurrent conditions, medical history, historical drug, concomitant therapies were not provided.  On 27-JUL-2020, the patient was vaccinated with an expired rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (dosage regimen was not provided) lot # R033251, expiration date 29-JUN-2020, taken orally, as prophylaxis. No additional adverse event was reported.
Sex: U
Vaccine: VARZOS
Symptoms: Malaise, Pain
Clinical narrative: achy/sore,; don't feel like getting out of; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21st July 2020, the patient received Shingrix. In July 2020, less than a week after receiving Shingrix, the patient experienced pain and malaise. On an unknown date, the outcome of the pain was not recovered/not resolved and the outcome of the malaise was unknown.   It was unknown if the reporter considered the pain and malaise 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 selected as an adult as per vaccine indication. The patient received Shingrix vaccine and had achy, sore, and don't felt like getting out of bed. The patient asked how long would it last.
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Myalgia, Pyrexia
Clinical narrative: tiredness; a minor fever; muscle pain; This case was reported by a consumer via interactive digital media and described the occurrence of muscle pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. In July 2020, unknown after receiving Shingrix, the patient experienced muscle pain. On an unknown date, the patient experienced tiredness and fever. On an unknown date, the outcome of the muscle pain was not recovered/not resolved and the outcome of the tiredness and fever were unknown.   It was unknown if the reporter considered the muscle pain, tiredness and fever 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 selected as an adult as per vaccine indication. The patient received Shingrix and experinced muscle pain, tiredness and a minor fever. The patient inquired what would do to alleviate them.
Age: 78.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Abdominal distension, Extra dose administered, Muscular weakness
Clinical narrative: received a third dose of Shingrix yesterday July 28, 2020; her legs were feeling weak; she was bloated.; This case was reported by a pharmacist via call center representative and described the occurrence of lower extremities weakness of in a elderly female patient who received Herpes zoster (Shingrix) (batch number NG5N7, expiry date 1st April 2022) for prophylaxis.   Co-suspect products included DTPa (Reduced antigen) (Boostrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 7th July 2018) and Shingrix (2nd dose received on 29th December 2018).   On 27th July 2020, the patient received the 3rd dose of Shingrix (intramuscular) and Boostrix. In July 2020, less than a week after receiving Shingrix and Boostrix, the patient experienced lower extremities weakness of and bloating. On an unknown date, the patient experienced extra dose administered. On an unknown date, the outcome of the lower extremities weakness of, bloating and extra dose administered were unknown.   It was unknown if the reporter considered the lower extremities weakness of and bloating to be related to Shingrix and Boostrix.  Additional information was provided as follows: The age at vaccination was not reported, but could be 78 or 79 years old. The patient received 3rd dose of Shingrix vaccine, which led to an extra dose administered. The patient reported her legs were feeling weak and she was bloated. Pharmacist did not believe the bloating was related to the vaccinations. No further details provided at the time of the call.  The reporter consented to follow up.
Age: 16.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Injection site pain, Neck pain, Pain in extremity
Clinical narrative: Pain in Left arm, shoulder, neck
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Hives on Arm, thigh, torso, and neck
Age: 27.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Mass, Pain
Clinical narrative: Sore left deltoid and left side of collarbone day following vaccine, upon waking on 7/31/2020 there is a lump on left collarbone, possibly a swollen lymph node. If swelling does not go down within a couple days patient will go to a doctor to get it looked at.
Age: 16.0
Sex: M
Vaccine: HEPA
Symptoms: Incorrect dose administered
Clinical narrative: Patient is 16 years old and should have been given the pediatric/adolescent formulation of Havrix, instead he was given the adult formulation of Havrix.   Provider, patient's mother, and immunization branch notified.  Correct formulation will be given in 6 months.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Erythema, Pyrexia, Swelling
Clinical narrative: localized swelling and redness for 48 hrs, chills and fever through the night after vaccination.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: C-reactive protein increased, Myositis
Clinical narrative: Myositis
Age: 16.0
Sex: M
Vaccine: MENB, MENB
Symptoms: Chills, Fatigue, Headache, Pyrexia
Clinical narrative: Fever (101), headache, chills, fatigue
Age: 16.0
Sex: M
Vaccine: MENB, MENB
Symptoms: Chills, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: Fever (101), headache, chills, fatigue
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Arthralgia, Pyrexia
Clinical narrative: Patient had joint pain and fever for 24 hours
Age: 24.0
Sex: F
Vaccine: VARCEL
Symptoms: Headache, Injection site erythema, Nausea, Pyrexia, Rash
Clinical narrative: Injections site redness, rash on injection arm, stomach and legs.  Low-grade fever (max 100.3), nausea/vomiting, headache
Age: 24.0
Sex: F
Vaccine: VARCEL
Symptoms: Vomiting
Clinical narrative: Injections site redness, rash on injection arm, stomach and legs.  Low-grade fever (max 100.3), nausea/vomiting, headache
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Urticaria, Wheezing
Clinical narrative: full body hives for 5 days  wheezing on and off for 36 hours treatment ; Benadryl,  Prednisone
Age: 52.0
Sex: M
Vaccine: UNK
Symptoms: Fatigue, Headache, Injection site pain, Pyrexia
Clinical narrative: Severe fatigue, injection site pain, headache, and fever (100° F)
Age: 49.0
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia, Pyrexia
Clinical narrative: Patient experienced significant muscle pain starting at 9pm 7/30/2020.  Low grade (99)fever throughout night.  Fever spiked to 101 F at 7am 7/31/2020. Patient using Tylenol 1000mg every 4-6 hrs. as needed
Age: 17.0
Sex: M
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: Syncope episode 20 minutes after vaccine
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Blood pressure increased, Headache
Clinical narrative: Blood pressure spiked to 181/152, pt experienced severe headache. Pt taken to ER where he was given torradol and Benadryl IV
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Severe swelling of the arm from shoulder to elbow, redness from shoulder to elbow, extreme pain from shoulder to elbow
Age: 34.0
Sex: F
Vaccine: PPV
Symptoms: Fatigue, Injection site pain, Injection site rash, Injection site swelling, Vomiting
Clinical narrative: Rash at the injection site. Severe pain and swelling at the injection site. Vomiting. Fatigue.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Redness, Swelling in effected area, soreness.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Injection site swelling
Clinical narrative: Swelling in RT began on 7/26/20, 5 days after vaccine administration. Swelling continue to increase in size. Family called today and swelling was approximately 3inches long by 2-3inches wide across RT. Recommend ice, ibuprofen, watch for signs/symptoms of infection. Follow up PRN. Will hold off on giving booster vaccine.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Myalgia, Pyrexia, Somnolence
Clinical narrative: fever sitting at 100.1, severe headache, drowsiness, and muscle ache
Age: 58.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Mobility decreased, Pain, Pyrexia
Clinical narrative: full body aches, tem spike to 103, could not get out of bed the next day..2nd day after still pain, body aches, fever but seems to be improving
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain
Clinical narrative: soreness at injection site
Age: 1.17
Sex: M
Vaccine: MMRV
Symptoms: Abnormal behaviour, Asthenia, Body temperature decreased, Fatigue, Neutropenia
Clinical narrative: My son had high fever and two low grade fevers of 94 degrees. So we took him to ER. We kept we him over night bc of the low grade fever and very low neutrophil level of .485. Normal is .1000  He was very tired and weak. He had thrown up as well.  He was not himself for over 3 weeks. And my doctor was worried that he developed neutropenia.
Age: 1.17
Sex: M
Vaccine: MMRV
Symptoms: Neutrophil count decreased, Pyrexia, Vomiting, White blood cell count decreased
Clinical narrative: My son had high fever and two low grade fevers of 94 degrees. So we took him to ER. We kept we him over night bc of the low grade fever and very low neutrophil level of .485. Normal is .1000  He was very tired and weak. He had thrown up as well.  He was not himself for over 3 weeks. And my doctor was worried that he developed neutropenia.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site inflammation, Palpitations
Clinical narrative: Today, I got a phone call from pt's husband about his wife's reaction after getting shingrix vaccine. On day 1(07/28/2020), pt got heart palpitation which is disappeared now. But Pt started to feel headache and red inflamed site reaction from day 2 to upto now. According to pt's husband, pt felt better day by day. He got consulted that pt can take tyrenol for headache and use ice pack for the injection site.
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Activated partial thromboplastin time shortened, Alanine aminotransferase increased, Anion gap, Antibody test negative, Aspartate aminotransferase increased
Clinical narrative: Developed bruising, wet purpura, and petechiae on 7/24/20 followed by hematuria. Platelets less than 5k. Admitted to hospital on 7/26 where he received IVIG treatment for immune thrombocytopenic purpura. Continued to have hematuria  after IVIG before resolution on 7/31. Underwent bone marrow biopsy consistent with ITP with increased in megakaryocytes. Started on steroid treatment due to continued thrombocytopenia ~96 hours after IVIG administration.  Symptoms began to resolve on 7/31 - discharged home, but platelets still 9k.
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Bacterial test negative, Basophil count decreased, Basophil percentage decreased, Bilirubin conjugated normal, Bilirubin urine
Clinical narrative: Developed bruising, wet purpura, and petechiae on 7/24/20 followed by hematuria. Platelets less than 5k. Admitted to hospital on 7/26 where he received IVIG treatment for immune thrombocytopenic purpura. Continued to have hematuria  after IVIG before resolution on 7/31. Underwent bone marrow biopsy consistent with ITP with increased in megakaryocytes. Started on steroid treatment due to continued thrombocytopenia ~96 hours after IVIG administration.  Symptoms began to resolve on 7/31 - discharged home, but platelets still 9k.
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Biopsy bone marrow abnormal, Blood albumin decreased, Blood alkaline phosphatase normal, Blood bilirubin normal, Blood calcium decreased
Clinical narrative: Developed bruising, wet purpura, and petechiae on 7/24/20 followed by hematuria. Platelets less than 5k. Admitted to hospital on 7/26 where he received IVIG treatment for immune thrombocytopenic purpura. Continued to have hematuria  after IVIG before resolution on 7/31. Underwent bone marrow biopsy consistent with ITP with increased in megakaryocytes. Started on steroid treatment due to continued thrombocytopenia ~96 hours after IVIG administration.  Symptoms began to resolve on 7/31 - discharged home, but platelets still 9k.
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Blood chloride increased, Blood creatinine normal, Blood glucose normal, Blood group A, Blood immunoglobulin A normal
Clinical narrative: Developed bruising, wet purpura, and petechiae on 7/24/20 followed by hematuria. Platelets less than 5k. Admitted to hospital on 7/26 where he received IVIG treatment for immune thrombocytopenic purpura. Continued to have hematuria  after IVIG before resolution on 7/31. Underwent bone marrow biopsy consistent with ITP with increased in megakaryocytes. Started on steroid treatment due to continued thrombocytopenia ~96 hours after IVIG administration.  Symptoms began to resolve on 7/31 - discharged home, but platelets still 9k.
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Blood immunoglobulin G normal, Blood immunoglobulin M normal, Blood lactate dehydrogenase increased, Blood potassium normal, Blood sodium normal
Clinical narrative: Developed bruising, wet purpura, and petechiae on 7/24/20 followed by hematuria. Platelets less than 5k. Admitted to hospital on 7/26 where he received IVIG treatment for immune thrombocytopenic purpura. Continued to have hematuria  after IVIG before resolution on 7/31. Underwent bone marrow biopsy consistent with ITP with increased in megakaryocytes. Started on steroid treatment due to continued thrombocytopenia ~96 hours after IVIG administration.  Symptoms began to resolve on 7/31 - discharged home, but platelets still 9k.
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Blood urea normal, Blood uric acid normal, Blood urine present, Carbon dioxide normal, Chromaturia
Clinical narrative: Developed bruising, wet purpura, and petechiae on 7/24/20 followed by hematuria. Platelets less than 5k. Admitted to hospital on 7/26 where he received IVIG treatment for immune thrombocytopenic purpura. Continued to have hematuria  after IVIG before resolution on 7/31. Underwent bone marrow biopsy consistent with ITP with increased in megakaryocytes. Started on steroid treatment due to continued thrombocytopenia ~96 hours after IVIG administration.  Symptoms began to resolve on 7/31 - discharged home, but platelets still 9k.
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Contusion, Eosinophil count normal, Eosinophil percentage, Flow cytometry, Glucose urine absent
Clinical narrative: Developed bruising, wet purpura, and petechiae on 7/24/20 followed by hematuria. Platelets less than 5k. Admitted to hospital on 7/26 where he received IVIG treatment for immune thrombocytopenic purpura. Continued to have hematuria  after IVIG before resolution on 7/31. Underwent bone marrow biopsy consistent with ITP with increased in megakaryocytes. Started on steroid treatment due to continued thrombocytopenia ~96 hours after IVIG administration.  Symptoms began to resolve on 7/31 - discharged home, but platelets still 9k.
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Haematocrit decreased, Haematuria, Haemoglobin decreased, Haptoglobin decreased, Immature granulocyte percentage increased
Clinical narrative: Developed bruising, wet purpura, and petechiae on 7/24/20 followed by hematuria. Platelets less than 5k. Admitted to hospital on 7/26 where he received IVIG treatment for immune thrombocytopenic purpura. Continued to have hematuria  after IVIG before resolution on 7/31. Underwent bone marrow biopsy consistent with ITP with increased in megakaryocytes. Started on steroid treatment due to continued thrombocytopenia ~96 hours after IVIG administration.  Symptoms began to resolve on 7/31 - discharged home, but platelets still 9k.
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Immune thrombocytopenia, Immunoglobulin therapy, International normalised ratio normal, Laboratory test abnormal, Lymphocyte count increased
Clinical narrative: Developed bruising, wet purpura, and petechiae on 7/24/20 followed by hematuria. Platelets less than 5k. Admitted to hospital on 7/26 where he received IVIG treatment for immune thrombocytopenic purpura. Continued to have hematuria  after IVIG before resolution on 7/31. Underwent bone marrow biopsy consistent with ITP with increased in megakaryocytes. Started on steroid treatment due to continued thrombocytopenia ~96 hours after IVIG administration.  Symptoms began to resolve on 7/31 - discharged home, but platelets still 9k.
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Lymphocyte percentage increased, Mean cell haemoglobin concentration normal, Mean cell haemoglobin normal, Mean cell volume decreased, Mean platelet volume
Clinical narrative: Developed bruising, wet purpura, and petechiae on 7/24/20 followed by hematuria. Platelets less than 5k. Admitted to hospital on 7/26 where he received IVIG treatment for immune thrombocytopenic purpura. Continued to have hematuria  after IVIG before resolution on 7/31. Underwent bone marrow biopsy consistent with ITP with increased in megakaryocytes. Started on steroid treatment due to continued thrombocytopenia ~96 hours after IVIG administration.  Symptoms began to resolve on 7/31 - discharged home, but platelets still 9k.
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Megakaryocytes increased, Monocyte count increased, Monocyte percentage increased, Neutrophil count normal, Neutrophil percentage decreased
Clinical narrative: Developed bruising, wet purpura, and petechiae on 7/24/20 followed by hematuria. Platelets less than 5k. Admitted to hospital on 7/26 where he received IVIG treatment for immune thrombocytopenic purpura. Continued to have hematuria  after IVIG before resolution on 7/31. Underwent bone marrow biopsy consistent with ITP with increased in megakaryocytes. Started on steroid treatment due to continued thrombocytopenia ~96 hours after IVIG administration.  Symptoms began to resolve on 7/31 - discharged home, but platelets still 9k.
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Nitrite urine absent, Nucleated red cells, Petechiae, Platelet count decreased, Polychromasia
Clinical narrative: Developed bruising, wet purpura, and petechiae on 7/24/20 followed by hematuria. Platelets less than 5k. Admitted to hospital on 7/26 where he received IVIG treatment for immune thrombocytopenic purpura. Continued to have hematuria  after IVIG before resolution on 7/31. Underwent bone marrow biopsy consistent with ITP with increased in megakaryocytes. Started on steroid treatment due to continued thrombocytopenia ~96 hours after IVIG administration.  Symptoms began to resolve on 7/31 - discharged home, but platelets still 9k.
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Protein total normal, Protein urine present, Prothrombin time prolonged, Purpura, Red blood cell anisocytes present
Clinical narrative: Developed bruising, wet purpura, and petechiae on 7/24/20 followed by hematuria. Platelets less than 5k. Admitted to hospital on 7/26 where he received IVIG treatment for immune thrombocytopenic purpura. Continued to have hematuria  after IVIG before resolution on 7/31. Underwent bone marrow biopsy consistent with ITP with increased in megakaryocytes. Started on steroid treatment due to continued thrombocytopenia ~96 hours after IVIG administration.  Symptoms began to resolve on 7/31 - discharged home, but platelets still 9k.
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Red blood cell count decreased, Red blood cell microcytes present, Red blood cell nucleated morphology, Red blood cells urine positive, Red cell distribution width
Clinical narrative: Developed bruising, wet purpura, and petechiae on 7/24/20 followed by hematuria. Platelets less than 5k. Admitted to hospital on 7/26 where he received IVIG treatment for immune thrombocytopenic purpura. Continued to have hematuria  after IVIG before resolution on 7/31. Underwent bone marrow biopsy consistent with ITP with increased in megakaryocytes. Started on steroid treatment due to continued thrombocytopenia ~96 hours after IVIG administration.  Symptoms began to resolve on 7/31 - discharged home, but platelets still 9k.
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Red cell distribution width normal, Reticulocyte count increased, Rhesus antigen positive, SARS-CoV-2 test negative, Specific gravity urine normal
Clinical narrative: Developed bruising, wet purpura, and petechiae on 7/24/20 followed by hematuria. Platelets less than 5k. Admitted to hospital on 7/26 where he received IVIG treatment for immune thrombocytopenic purpura. Continued to have hematuria  after IVIG before resolution on 7/31. Underwent bone marrow biopsy consistent with ITP with increased in megakaryocytes. Started on steroid treatment due to continued thrombocytopenia ~96 hours after IVIG administration.  Symptoms began to resolve on 7/31 - discharged home, but platelets still 9k.