chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: Temperature: BELOW 36 Fahrenheit degrees/2 Celsius degrees (0.9 C to 1.9 C) for 10 hours; ABOVE 47 Fahrenheit degrees/9 Celsius degrees (9.1 C) for 30 minutes; This spontaneous report was received from an other healthcare professional and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On 26-OCT-2020, the patient was vaccinated with a dose of human papilloma virus (hpv) rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # T007035 has been verified to be a valid lot #, expiry date 01-MAY-2022) (dose, route of administration and anatomical location were not provided) for prophylaxis. The vaccine experienced temperature excursion before administration to the patient. It experienced temperature below 36 Fahrenheit degrees/ 2 Celsius degrees (temperature range 0.9 Celsius degrees to 1.9 Celsius degrees) for 10 hours and above 47 Fahrenheit degrees/ 9 Celsius degrees (9.1 Celsius degrees) for 30 minutes. There was no previous temperature excursion. No digital data logger was involved.  This is one of 4 reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T007035; expirationdate: 01-MAY-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2010USA011203: US-009507513-2010USA011375: US-009507513-2010USA011190:
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: No additional adverse effect reported; expired VAQTA (Lot S023220 Exp 10/20/2020) was inadvertently administered to a patient; This spontaneous report was received from a nurse practitioner, also reported as nurse prescriber who was reporting on a patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant therapies provided.  On 24-OCT-2020, the patient was inadvertently vaccinated with expired dose of hepatitis a vaccine, inactivated (VAQTA) vial (strength, exact dose, route of administration and anatomical location were not reported; lot number S023220 was confirmed to be valid, expiration date 20-OCT-2020 was confirmed) for prophylaxis. There was no additional adverse event reported.
Age: 48.0
Sex: M
Vaccine: PPV, UNK
Symptoms: Injection site pain, Malaise, Pyrexia
Clinical narrative: extreme soreness at the injection site, in his left arm, were PNEUMOVAX 23 was given; the patient may have the flu; the patient is not feeling well; fever from 101 that increased to 103; This spontaneous report was received from a pharmacist and refers to a 48 years old male patient with a history of cardiac issue (specific diagnosis was unknown by the reporter). The reporter learned about the event' from the patient's wife. No information on the patient's drug reactions or allergies was provided.  On 29-OCT-2020, the patient was vaccinated with a single dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot # T021485, expiration date: 13-MAR-2022, 0.5 milliliter, injection in the left arm and concomitantly with an influenza virus vaccine (manufacturer unknown) (reported as "FLU vaccine").  On 30-OCT-2020, the patient experienced a fever from 101 that increased to 103 (units not provided) and his wife drove the patient to the emergency room. The patient also experienced extreme soreness at the injection site, in his left arm, were pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was given and was hospitalized on the same day due to this event. The patient's wife also provided that he was not feeling well and she thought the patient might have the flu. It was unknown whether any treatment for the events was given.  The outcome of the events was unknown and the relatedness between the events and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not reported. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: T021485; expirationdate: 15-MAR-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
Sex: F
Vaccine: HEPA
Symptoms: Product administered at inappropriate site
Clinical narrative: No additional adverse events reported; The patient was receiving several unspecified vaccines and the medical assistant who was administering them wanted separate sites for each so used the gluteus maximus for the VAQTA; who was administering them wanted separate sites for each so used the gluteus maximus for the VAQTA; This spontaneous report as received from a medical assistant refers to a 21 year old female patient of unknown age. There was no information about the patient's medical history or concurrent conditions. Concomitant therapies include several unspecified routine vaccines. An adult dose of hepatitis a vaccine, inactivated(VAQTA) was administered in the gluteus maximus (lot # S037821, expiration date. 07-JAN-2021) (dose and frequency were not reported) for prophylaxis, on 13-OCT-2020. The patient was receiving several unspecified vaccines and the medical assistant who was administering them wanted separate sites for each so used the gluteus maximus for the of hepatitis a vaccine, inactivated (VAQTA)(Off label use), on the same date. No additional adverse events reported.
Sex: U
Vaccine: VARZOS
Symptoms: Blindness unilateral, Deafness, Hepatic failure, Herpes zoster, Pneumonia
Clinical narrative: blindness in left eye; hearing loss; seizure; pneumonia; liver failure; herpes zoster; Information has been received from a lawyer, regarding a case in litigation, and refers to a patient (pt) of unknown age and gender. No information about the pt's medical history, concurrent conditions and concomitant medications was provided. On or about 14-OCT-2015, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On unknown dates, shortly after receiving zoster vaccine live (ZOSTAVAX), the pt suffered from herpes zoster, blindness in left eye, hearing loss, seizure, pneumonia and liver failure. As a result of these symptoms, the pt was seen and treated by medical providers and had been still under their care. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt's symptoms had resulted in physical limitations not present prior to using the suspect vaccine. The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of the pt's condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence, the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, the pt had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was considered to be not recovered/not resolved. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).  The events of blindness unilateral, deafness, seizure, pneumonia, hepatic failure, and herpes zoster were considered to be disabling. Upon internal review, the events of blindness unilateral, deafness, seizure, pneumonia, and hepatic failure were determined to be medically significant.
Sex: U
Vaccine: VARZOS
Symptoms: Seizure
Clinical narrative: blindness in left eye; hearing loss; seizure; pneumonia; liver failure; herpes zoster; Information has been received from a lawyer, regarding a case in litigation, and refers to a patient (pt) of unknown age and gender. No information about the pt's medical history, concurrent conditions and concomitant medications was provided. On or about 14-OCT-2015, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On unknown dates, shortly after receiving zoster vaccine live (ZOSTAVAX), the pt suffered from herpes zoster, blindness in left eye, hearing loss, seizure, pneumonia and liver failure. As a result of these symptoms, the pt was seen and treated by medical providers and had been still under their care. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt's symptoms had resulted in physical limitations not present prior to using the suspect vaccine. The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of the pt's condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence, the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, the pt had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was considered to be not recovered/not resolved. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).  The events of blindness unilateral, deafness, seizure, pneumonia, hepatic failure, and herpes zoster were considered to be disabling. Upon internal review, the events of blindness unilateral, deafness, seizure, pneumonia, and hepatic failure were determined to be medically significant.
Sex: M
Vaccine: FLUX, HEPA, MMR, VARCEL
Symptoms: Pyrexia, Rash, Rash maculo-papular
Clinical narrative: low grade fever; facial rash; generalized maculopapular rash; facial rash; This spontaneous report was received from a company representative and refers to a 1-year-old male patient. The patient had no medical history or previous drug reactions or allergies. No information regarding the patient's concurrent conditions or concomitant medications and was reported.  On an unknown date, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX), measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), hepatitis a virus vaccine inactivated (HAVRIX) and an unspecified influenza virus vaccine (strength, dose, route of administration, lot number and expiration date were not provided) for prophylaxis.  On an unknown date, 2 days after the vaccinations, the patient experienced low grade fever and a facial rash. The patient recover from these events on an unknown date. Then, on an unknown date, (reported as about 12 days after vaccinations), the patient experienced generalized maculo-papular rash that lasted for 2 to 3 days. On an unknown date, the patient experienced another facial rash, which was treated with hydrocortisone cream. The patient sought medical attention. No laboratory studies or diagnostics were performed. On an unknown dates, the patient recovered from the events.   The causality assessment between the events and the suspect therapies was not provided.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Dizziness, Erythema, Feeling abnormal, Headache
Clinical narrative: Left arm was severely sore / could hardly touch her left arm; Headache; Fever; Throwing up; Weak; Arm still red; She was dizzy; She still doesn't feel like herself; This case was reported by a consumer via call center representative and described the occurrence of touch sensitivity increased in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site pain (1st dose received on 18th January 2020, please refer the case US2020AMR218566.).   On 18th March 2020, the patient received the 2nd dose of Shingrix. On 18th January 2020, less than a day after receiving Shingrix, the patient experienced touch sensitivity increased, headache, fever, vomiting, weakness, erythema of extremities, dizziness and feeling abnormal. On an unknown date, the outcome of the touch sensitivity increased, headache, fever, vomiting, weakness, erythema of extremities, dizziness and feeling abnormal were recovering/resolving.   It was unknown if the reporter considered the touch sensitivity increased, headache, fever, vomiting, weakness, erythema of extremities, dizziness and feeling abnormal to be related to Shingrix.  Additional details were provided as follows: The patient received the vaccine left arm. The patient experienced severely sore and headache, fever, throwing up, weak, she could hardly touch her left arm and it is still red. She was dizzy especially when laying down. She claims that the side effects started on the day of the injection and she still doesn't feel like herself. She still has a headache and her left arm is still red but she feels a whole lot better now.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Hyperaesthesia, Pain, Pyrexia, Tenderness, Vomiting
Clinical narrative: Left arm was severely sore / could hardly touch her left arm; Headache; Fever; Throwing up; Weak; Arm still red; She was dizzy; She still doesn't feel like herself; This case was reported by a consumer via call center representative and described the occurrence of touch sensitivity increased in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site pain (1st dose received on 18th January 2020, please refer the case US2020AMR218566.).   On 18th March 2020, the patient received the 2nd dose of Shingrix. On 18th January 2020, less than a day after receiving Shingrix, the patient experienced touch sensitivity increased, headache, fever, vomiting, weakness, erythema of extremities, dizziness and feeling abnormal. On an unknown date, the outcome of the touch sensitivity increased, headache, fever, vomiting, weakness, erythema of extremities, dizziness and feeling abnormal were recovering/resolving.   It was unknown if the reporter considered the touch sensitivity increased, headache, fever, vomiting, weakness, erythema of extremities, dizziness and feeling abnormal to be related to Shingrix.  Additional details were provided as follows: The patient received the vaccine left arm. The patient experienced severely sore and headache, fever, throwing up, weak, she could hardly touch her left arm and it is still red. She was dizzy especially when laying down. She claims that the side effects started on the day of the injection and she still doesn't feel like herself. She still has a headache and her left arm is still red but she feels a whole lot better now.
Age: 51.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Erythema, Injection site reaction, Mobility decreased, Pain
Clinical narrative: Left shoulder/upper arm pain, swelling, redness and warmth to touch. Sever throbbing at site. Trouble lifting her arm.
Age: 51.0
Sex: F
Vaccine: PPV
Symptoms: Skin warm, Swelling
Clinical narrative: Left shoulder/upper arm pain, swelling, redness and warmth to touch. Sever throbbing at site. Trouble lifting her arm.
Age: 51.0
Sex: U
Vaccine: PNC13
Symptoms: Erythema, Hypoaesthesia, Pain, Swelling
Clinical narrative: severe swelling, pain, redness causing numbness down the left arm. Tried Aleve, Benadryl, Heat. Tx'd with Prednisone
Age: 50.0
Sex: U
Vaccine: FLU4, TDAP
Symptoms: Injection site nodule, Injection site swelling
Clinical narrative: Pt began to swell/knot at injection site immediately after administration of flu vaccine. Per pt, similar reaction occurred 2/2020 with flu vaccine in left deltoid.
Age: 14.0
Sex: M
Vaccine: HPV4
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 17.0
Sex: F
Vaccine: FLU4, MENB
Symptoms: Injection site warmth, Lymphadenopathy, Rash erythematous, Rash pruritic
Clinical narrative: Red, itchy rash 14x11 cm and felt warm around injection site on left thigh x 5 days.  Was evaluated at day 7 post vaccination with swollen lymph nodes in the groin.
Age: 35.0
Sex: F
Vaccine: MNQ
Symptoms: Arthralgia, Fatigue, Headache, Influenza like illness, Musculoskeletal stiffness
Clinical narrative: flu-like symtoms fever  body aches joint pain headache neck pain & stiffness fatigue nausea
Age: 35.0
Sex: F
Vaccine: MNQ
Symptoms: Nausea, Neck pain, Pain, Pyrexia
Clinical narrative: flu-like symtoms fever  body aches joint pain headache neck pain & stiffness fatigue nausea
Age: 32.0
Sex: F
Vaccine: FLUR4
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: erythema, edema, and warmth to area below injection site
Age: 39.0
Sex: F
Vaccine: FLUA3
Symptoms: Erythema, Pain, Rash papular, Skin warm
Clinical narrative: I went to pharmacy to get my flu shot and noticed shortly after it was really red I didmt pay much attention woke up this morning amd I have a horrible raised rash amd it is very hot to the touch and sore.
Age: 73.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: Injection site reaction with swelling, rash, and tenderness. Fully resolved within 4 days without medical intervention.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Dry skin, Erythema, Injection site discolouration, Injection site pain, Injection site vesicles
Clinical narrative: I got the Shot at my local Pharmacy. on 11/3/2020.   It was my second shot.  The injection sight started hurting around 9 pm.  I  put ice on it a couple of times.  The pain woke me up several time throughout the night.  I felt my arm, it was warm and felt rough.  I got up and looked in the mirror.   There were two spots.  One was red circle around the side of my arm and underneath in the injection sight was very dark skin and several blisters.  They seemed to be in a row.  That was in the morning of 11/4/2020..  I went to the Pharmacy around noon on 11/4/2020 and had the Pharmacist look at it.  It was pretty sore.  He was very shocked and said he would call the company that made the vaccine.  At that time I was not in any pain.   He called me about 2pm on 11/4/2020 and told me that the company said it was a rare reaction.  I took Ibuprophen for swelling later on that day.  When I was sleeping on 11/5/2020, I woke up several times with pain.  When I got up in the morning of of 11/6/2020 I noticed that a few blisters had gotten bigger,  the dark circle was hot and it was painful.  I called my Dr.  and they saw at 10:40 .  Two nurses and two Drs. saw my sight from the injection.  They were not sure how to treat it but came to the conclusion to treat it as a bacterial infection with Bactrim.    I continuue to be in pain and the spot it always felt.  It is very warm and my arm to my elbow is a little red and also warm.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Skin warm, Sleep disorder, Vaccination complication
Clinical narrative: I got the Shot at my local Pharmacy. on 11/3/2020.   It was my second shot.  The injection sight started hurting around 9 pm.  I  put ice on it a couple of times.  The pain woke me up several time throughout the night.  I felt my arm, it was warm and felt rough.  I got up and looked in the mirror.   There were two spots.  One was red circle around the side of my arm and underneath in the injection sight was very dark skin and several blisters.  They seemed to be in a row.  That was in the morning of 11/4/2020..  I went to the Pharmacy around noon on 11/4/2020 and had the Pharmacist look at it.  It was pretty sore.  He was very shocked and said he would call the company that made the vaccine.  At that time I was not in any pain.   He called me about 2pm on 11/4/2020 and told me that the company said it was a rare reaction.  I took Ibuprophen for swelling later on that day.  When I was sleeping on 11/5/2020, I woke up several times with pain.  When I got up in the morning of of 11/6/2020 I noticed that a few blisters had gotten bigger,  the dark circle was hot and it was painful.  I called my Dr.  and they saw at 10:40 .  Two nurses and two Drs. saw my sight from the injection.  They were not sure how to treat it but came to the conclusion to treat it as a bacterial infection with Bactrim.    I continuue to be in pain and the spot it always felt.  It is very warm and my arm to my elbow is a little red and also warm.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash erythematous, Rash vesicular, Varicella zoster virus infection
Clinical narrative: Pt broke out with acute shingles/Varicella Zoster on his left abdomen and left posterior thorax as of 9-27-20, 10 days after receiving his 1st Shingrix vaccine.  Pt had a vessicular rash on erythematous base starting left of spine and ending left center of abdomen in line with T-11 and T-12 dermatomes
Age: 75.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Myalgia, Pyrexia
Clinical narrative: High fever and Severe muscle aches. Started the evening of the injections and was completely gone the next morning
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Musculoskeletal chest pain, Pain, Pain in extremity, Sleep disorder
Clinical narrative: Patient reports of sore arm extending over a long period of time. She stated that she still cannot sleep on that arm and the pain sometimes radiates to her shoulder and rib area. She stated she is able to live with the pain but just wanted to report that it is still ongoing. She stated she had her primary physician take a look at the arm and did not see any visible problems.
Age: 56.0
Sex: M
Vaccine: FLU4
Symptoms: Unevaluable event
Clinical narrative: Patient was administered adult dose of vaccine even after  indicating on question 7 of the 2020/2021  Influenza Vaccination Screening form that he was feeling sick.
Age: 13.0
Sex: F
Vaccine: FLU4
Symptoms: Cold sweat, Dizziness, Pallor
Clinical narrative: Mother and child were checking out when patient became light headed. She was assisted to a prone position by staff, where Vital signs were taken. Patient's Color was pale and skin was clammy. After lying in prone position for approximately 10 minutes, she was able to sit up and stand on her own with no issues. Dr. came out to the lobby and talked to patient when she was feeling better. Child walked out of the clinic  with mother.
Age: 16.0
Sex: F
Vaccine: FLU4, MNQ
Symptoms: Dizziness, Vomiting
Clinical narrative: Pt tolerated well, then few minutes after injections reported dizziness, feeling faint. Pt emesis x1. Vital signs were taken, BP/temp/heart rate all stable. Pt laid down x15 mins and RN and charge RN assessed. Pt provided juice to drink. Pt stable to leave office. No previous rxs to vaccines.
Sex: U
Vaccine: VARZOS
Symptoms: Arthralgia, Herpes zoster, Neck pain, Polymyalgia rheumatica
Clinical narrative: Patient has been diagnosed with polymyalgia rheumatica; Patient has been diagnosed with shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation referring to a patient (pt) of unknown age and gender. The pt's pertinent medical history, concurrent conditions or concomitant medications were not reported. On or about 06-MAY-2010, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dosage and route of administration were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unspecified date, shortly after receiving zoster vaccine live (ZOSTAVAX), the pt suffered sudden onset of neck, shoulder, knee and hip pain. The pt was diagnosed with shingles and polymyalgia rheumatica. It was also specified that the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The events were considered to be related to zoster vaccine live (ZOSTAVAX) vaccination.  Upon internal review, polymyalgia rheumatica was considered medically significant. Additionally, the events were considered to be disabling due to serious, permanent and incurable injuries.
Age: 16.0
Sex: M
Vaccine: HPV9
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No additional adverse event reported; a patient received a fourth dose of Gardasil 9; This spontaneous report was received from a physician concerning a 16-years old male patient. The patient's medical history, concurrent conditions, concomitant medications, and drug allergies were not reported.   On unknown dates, the patient was vaccinated with the first, second and third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) for prophylaxis (strengths, routes of administrations, anatomical sites of injections, lot numbers, and expiration dates were not reported).   On 28-OCT-2020,  the patient was vaccinated with the fourth dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) for prophylaxis (strength, route of administration, anatomical site of injection, lot number, and expiration date were not reported) (inappropriate schedule of product administration). No additional adverse event reported, nor product quality complain involved.
Age: 26.0
Sex: M
Vaccine: FLUN4
Symptoms: Abdominal discomfort, Abdominal pain upper, Decreased appetite, Dyspepsia, Facial pain
Clinical narrative: SNEEZING; SINUS PRESSURE; FELT ALOT OF SORENESS AND TENDERNESS IN HIS CHEEKS; LOSS OF APPETITE; SERIOUS DIGESTION ISSUES; STOMACH PROBLEMS; NAUSEA; STOMACH PAIN; RUNNY AND STUFFY NOSE; TASTED IT IN HIS THROAT; NORMAL CONGESTION; A spontaneous report has been received from a consumer. The report concerns a male patient born in 1996 (height 71 in, weight 130 lb).    No medical history was reported. The following demography was reported for the patient's parent:   Sex: Unknown    No concomitant products were reported.    The patient received Flumist Quadrivalent (influenza virus vaccine live, intranasal) (batch number Unknown) 0.2 ml once/single administration, via nasal route, for flu prevention on 01-OCT-2020.     On an unknown date, the patient experienced sneezing (preferred term: Sneezing). On an unknown date, the patient experienced sinus pressure (preferred term: Paranasal sinus discomfort). On an unknown date, the patient experienced felt alot of soreness and tenderness in his cheeks (preferred term: Facial pain). On an unknown date, the patient experienced loss of appetite (preferred term: Decreased appetite). On an unknown date, the patient experienced serious digestion issues (preferred term: Dyspepsia). On an unknown date, the patient experienced stomach problems (preferred term: Abdominal discomfort). On an unknown date, the patient experienced nausea (preferred term: Nausea). On an unknown date, the patient experienced stomach pain (preferred term: Abdominal pain upper). On an unknown date, the patient experienced tasted it in his throat (preferred term: Taste disorder). On an unknown date, the patient experienced runny and stuffy nose (preferred term: Rhinorrhoea). On an unknown date, the patient experienced normal congestion (preferred term: Nasal congestion).     Treatment with Flumist Quadrivalent (influenza virus vaccine live, intranasal) was not changed.     The outcome of the event(s) of sneezing, sinus pressure, felt alot of soreness and tenderness in his cheeks, loss of appetite, serious digestion issues, stomach problems, nausea, stomach pain, runny and stuffy nose, tasted it in his throat and normal congestion was unknown.     The events were considered non-serious.
Age: 26.0
Sex: M
Vaccine: FLUN4
Symptoms: Nasal congestion, Nausea, Paranasal sinus discomfort, Rhinorrhoea, Secretion discharge
Clinical narrative: SNEEZING; SINUS PRESSURE; FELT ALOT OF SORENESS AND TENDERNESS IN HIS CHEEKS; LOSS OF APPETITE; SERIOUS DIGESTION ISSUES; STOMACH PROBLEMS; NAUSEA; STOMACH PAIN; RUNNY AND STUFFY NOSE; TASTED IT IN HIS THROAT; NORMAL CONGESTION; A spontaneous report has been received from a consumer. The report concerns a male patient born in 1996 (height 71 in, weight 130 lb).    No medical history was reported. The following demography was reported for the patient's parent:   Sex: Unknown    No concomitant products were reported.    The patient received Flumist Quadrivalent (influenza virus vaccine live, intranasal) (batch number Unknown) 0.2 ml once/single administration, via nasal route, for flu prevention on 01-OCT-2020.     On an unknown date, the patient experienced sneezing (preferred term: Sneezing). On an unknown date, the patient experienced sinus pressure (preferred term: Paranasal sinus discomfort). On an unknown date, the patient experienced felt alot of soreness and tenderness in his cheeks (preferred term: Facial pain). On an unknown date, the patient experienced loss of appetite (preferred term: Decreased appetite). On an unknown date, the patient experienced serious digestion issues (preferred term: Dyspepsia). On an unknown date, the patient experienced stomach problems (preferred term: Abdominal discomfort). On an unknown date, the patient experienced nausea (preferred term: Nausea). On an unknown date, the patient experienced stomach pain (preferred term: Abdominal pain upper). On an unknown date, the patient experienced tasted it in his throat (preferred term: Taste disorder). On an unknown date, the patient experienced runny and stuffy nose (preferred term: Rhinorrhoea). On an unknown date, the patient experienced normal congestion (preferred term: Nasal congestion).     Treatment with Flumist Quadrivalent (influenza virus vaccine live, intranasal) was not changed.     The outcome of the event(s) of sneezing, sinus pressure, felt alot of soreness and tenderness in his cheeks, loss of appetite, serious digestion issues, stomach problems, nausea, stomach pain, runny and stuffy nose, tasted it in his throat and normal congestion was unknown.     The events were considered non-serious.
Age: 26.0
Sex: M
Vaccine: FLUN4
Symptoms: Sneezing, Tenderness
Clinical narrative: SNEEZING; SINUS PRESSURE; FELT ALOT OF SORENESS AND TENDERNESS IN HIS CHEEKS; LOSS OF APPETITE; SERIOUS DIGESTION ISSUES; STOMACH PROBLEMS; NAUSEA; STOMACH PAIN; RUNNY AND STUFFY NOSE; TASTED IT IN HIS THROAT; NORMAL CONGESTION; A spontaneous report has been received from a consumer. The report concerns a male patient born in 1996 (height 71 in, weight 130 lb).    No medical history was reported. The following demography was reported for the patient's parent:   Sex: Unknown    No concomitant products were reported.    The patient received Flumist Quadrivalent (influenza virus vaccine live, intranasal) (batch number Unknown) 0.2 ml once/single administration, via nasal route, for flu prevention on 01-OCT-2020.     On an unknown date, the patient experienced sneezing (preferred term: Sneezing). On an unknown date, the patient experienced sinus pressure (preferred term: Paranasal sinus discomfort). On an unknown date, the patient experienced felt alot of soreness and tenderness in his cheeks (preferred term: Facial pain). On an unknown date, the patient experienced loss of appetite (preferred term: Decreased appetite). On an unknown date, the patient experienced serious digestion issues (preferred term: Dyspepsia). On an unknown date, the patient experienced stomach problems (preferred term: Abdominal discomfort). On an unknown date, the patient experienced nausea (preferred term: Nausea). On an unknown date, the patient experienced stomach pain (preferred term: Abdominal pain upper). On an unknown date, the patient experienced tasted it in his throat (preferred term: Taste disorder). On an unknown date, the patient experienced runny and stuffy nose (preferred term: Rhinorrhoea). On an unknown date, the patient experienced normal congestion (preferred term: Nasal congestion).     Treatment with Flumist Quadrivalent (influenza virus vaccine live, intranasal) was not changed.     The outcome of the event(s) of sneezing, sinus pressure, felt alot of soreness and tenderness in his cheeks, loss of appetite, serious digestion issues, stomach problems, nausea, stomach pain, runny and stuffy nose, tasted it in his throat and normal congestion was unknown.     The events were considered non-serious.
Age: 18.0
Sex: M
Vaccine: TD
Symptoms: Expired product administered
Clinical narrative: patient received a dose of Tenivac on 22nd of Oct that had expired on the 12th of October2020, No AE; Initial information received on 22-Oct-2020 regarding an unsolicited valid non-serious case from an other healthcare professional.  This case involves a 18 years old male patient who was administered with0.5 ml expired first dose of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] (lot number- U6091AA and expiration date: 12-Oct-2020) via intramuscular route in left deltoid for prophylactic vaccination on 22nd of October 2020 (Expired product administered).  Medical history, past medical treatment(s), medical treatment(s), vaccination(s) and family history were not reported.  Concomitant medications included INFLUENZA VACCINE ; HPV VACCINE and HEPATITIS B VACCINE for prophylactic vaccination.  This was an actual medication error due to expired vaccine used [latency was same day].  No laboratory data reported.  At the time of reporting, no adverse event was reported to the patient.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 79.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Blister, Chills, Headache, Pain, Peripheral swelling
Clinical narrative: Chills, achiness, headaches, blistering on the left arm, and swelling.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Computerised tomogram, Feeling abnormal, Loss of personal independence in daily activities, Mobility decreased, Pain
Clinical narrative: After having the vaccine, that night had some soreness. Next day felt awful with low grade fever. It progressively got worse, temp reached 102. Arm swollen. Could not sleep in bed. Can't move arm up. Can't get dressed by herself. Still in a lot of pain. Went to ER.  Did a CT Scan. Gave Tramadol for pain. prescribed K flex.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Peripheral swelling, Pyrexia, Sleep disorder
Clinical narrative: After having the vaccine, that night had some soreness. Next day felt awful with low grade fever. It progressively got worse, temp reached 102. Arm swollen. Could not sleep in bed. Can't move arm up. Can't get dressed by herself. Still in a lot of pain. Went to ER.  Did a CT Scan. Gave Tramadol for pain. prescribed K flex.
Sex: F
Vaccine: UNK
Symptoms: Pruritus, Rash, Skin warm
Clinical narrative: Received the High dose flu vaccine 10/31. 11/3 Started developing an itch everywhere after vax.. Rash is abdomen up the way up to face. all over body excluding legs. Any heat touching the rash irritates it more.    Went to walk in clinic a few days later and they prescribed Zyrtec. Called PA and notified her PCP of rash. Rash is still persisting will be contacting Physician.
Age: 74.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Flushing, Syncope
Clinical narrative: Pt. collapsed 15 minutes after vaccine was given and was flushed.
Age: 58.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: patient came in one week after administration of vaccine. Her left arm (Shingrix) showed swelling, redness and patient said was warm to touch. Said no pain or itchiness. reported that it started almost a week after vaccine was administered. Told to put ice on to reduce swelling and also referred to physician for evaluation. Called to check in two days later and she said md gave her an antibiotic and that was getting a bit better
Age: 61.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Pain, Tenderness
Clinical narrative: Since day of immunization in the RIGHT arm until present: pain when laying on or moving this arm.
Age: 62.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Blood pressure increased, Dizziness, Electrocardiogram, Flushing, Hyperhidrosis
Clinical narrative: Patient administered vaccines at 1000. At 1005, while sitting in the patient room, the patient became diaphoretic, flushed, and felt as though he would faint. He called for help and nursing responded immediately. Dr in room promptly. Patient was positioned in semi-fowlers, a cool cloth on the forehead, windows opened for fresh air, blood pressure spiked at 218/110, pulse 78 (normal), SPO2: 96% (normal). Patient became pale with position transfer but did not faint. He improved rapidly, epi was not needed, patient did not complain of shortness of breath. Injection sites for both vaccines observed, no rash present on the body, no swelling or erythema at the sites of injection. EMS arrived, EKG completed, oxygen administered via nasal cannula. ER was contacted and given report, patient was transferred for further evaluation.
Age: 62.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Pallor
Clinical narrative: Patient administered vaccines at 1000. At 1005, while sitting in the patient room, the patient became diaphoretic, flushed, and felt as though he would faint. He called for help and nursing responded immediately. Dr in room promptly. Patient was positioned in semi-fowlers, a cool cloth on the forehead, windows opened for fresh air, blood pressure spiked at 218/110, pulse 78 (normal), SPO2: 96% (normal). Patient became pale with position transfer but did not faint. He improved rapidly, epi was not needed, patient did not complain of shortness of breath. Injection sites for both vaccines observed, no rash present on the body, no swelling or erythema at the sites of injection. EMS arrived, EKG completed, oxygen administered via nasal cannula. ER was contacted and given report, patient was transferred for further evaluation.
Age: 14.0
Sex: F
Vaccine: FLU4, HPV9
Symptoms: Dizziness, Hypotension, Immediate post-injection reaction, Nausea
Clinical narrative: Immediately after receiving HPV vaccine, patient felt nauseous and lightheaded. Patient placed in safe position and vital signs observed. Patient assessed to be hypotensive. Patient given fluids and rested. Parent contacted. Patient blood pressure symptoms stabilized within the hour and patient sent home with parent to rest.
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: She noticed swelling, redness and itching at the site of injection. Erythema about 8X8cm in size.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Influenza like illness, Malaise, Pain in extremity, Peripheral swelling
Clinical narrative: Raised bump on left arm with raised spots; extremely painful; swollen arm Malaise, tiredness, feel like have the flu
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Flushing, Injection site swelling, Mobility decreased, Pain
Clinical narrative: INJECTION SITE SWELLING SORENESS FACE RED AND FLUSHED ARM FROZEN - COULD NOT LIFT PROPERLY FOR 3 DAYS CONSTANT PAIN IN ARM HAND SWOLLEN AND "PALE"
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: INJECTION SITE SWELLING SORENESS FACE RED AND FLUSHED ARM FROZEN - COULD NOT LIFT PROPERLY FOR 3 DAYS CONSTANT PAIN IN ARM HAND SWOLLEN AND "PALE"
Age: 44.0
Sex: F
Vaccine: MMR
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: patient stated that almost immediately injection area started itching, continued to get worse;  red, tender and itching, area getting bigger
Age: 10.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Father reported redness and warmth to the injection site that started on 11/04/20.
Age: 61.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site muscle weakness, Injection site pain
Clinical narrative: He reports increased and lingering soreness to the injection site as well as slight weakness; denies any swelling or redness.  He did not have anyone examine the site; states it was very sore to touch for several weeks after vaccination; as of 11/6/20, he states that the soreness is almost completely gone
Age: 88.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site pruritus
Clinical narrative: itching at vaccine persisting
Age: 10.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Father reported redness and warmth to the injection site
Age: 67.0
Sex: F
Vaccine: FLU4
Symptoms: Fatigue, Hypersomnia, Mobility decreased, Pruritus, Pyrexia
Clinical narrative: has hives on the abdomen, itching with a low grade fever for 48 hours post injections, wasn't able to lift arm for 4 days after vax. Felt very tired and slept a lot and took IB. Feels ok now but rashes are fading and still itches.
Age: 67.0
Sex: F
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: has hives on the abdomen, itching with a low grade fever for 48 hours post injections, wasn't able to lift arm for 4 days after vax. Felt very tired and slept a lot and took IB. Feels ok now but rashes are fading and still itches.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Movement disorder, Product administered at inappropriate site
Clinical narrative: Patient received a Flu vaccine on 9/22/20. On 9/23 Patient states she could not move her arm. On 10/5 she sought treatment and received a steroid pack. The doctor thought vaccine may have been given too high. She has since had two more doses of Medrol 10/14/20 & 11/3/20. Patient is now awaiting an appointment with a specialist to determine next course of action.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Fall, Injection site pain, Limb injury, Loss of consciousness, Syncope
Clinical narrative: PT RECIEVED INJECTION ON 9-16; REPORTED ARM SORNESS AT INJECTION SITE AND SYNCOPE ON 9-17. PT PASSED OUT AND INJURED LEG DURING FALL. PT WAS TAKEN TO THE HOSPITAL WHERE TESTS WERE RUN.
Age: 77.0
Sex: M
Vaccine: FLU4
Symptoms: Arthralgia
Clinical narrative: Right shoulder pain
Age: 65.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Cellulitis, Chills, Dyspnoea, Nervousness, Peripheral swelling
Clinical narrative: 10/29/2020: SOB, fever, chills, feels shaky, and her arm is swollen. Advised pt to go to ED  Patient admitted for cellulitis/ sepsis.
Age: 65.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Pyrexia, Sepsis
Clinical narrative: 10/29/2020: SOB, fever, chills, feels shaky, and her arm is swollen. Advised pt to go to ED  Patient admitted for cellulitis/ sepsis.
Age: 52.0
Sex: F
Vaccine: FLUR4, VARZOS
Symptoms: Fatigue, Injection site pain, Rash
Clinical narrative: Soreness in upper left arm near site of injection. Rash across abdomen, back, and chest, fatigue. Rash started morning of 11/6/20. No medication yet.
Age: 45.0
Sex: M
Vaccine: FLUR4
Symptoms: Nausea, Oxygen saturation decreased, Pyrexia
Clinical narrative: patient developed a 102 degree fever, nausea, and oxygen dropped.  The event lasted about 24 hours then resolved
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Fall
Clinical narrative: Pt received the flu shot in the Left arm and pt states that she got lightheaded and she fell from a standing position forward and then fell to the floor.  EMS was called, but she refused and she asked for the EMS to be cancelled.  Pt stated that she feels fine now and really has no complaints.  Pt got up to a sitting position and then moved to a chair with no complaints or issues.  Pt stayed sitting in a chair for approximately 30 minutes with a cold compress to her head.  Patient had no injury.   RPh called the patient at 4:20 pm to check on her and she states that she is feeling fine and has no issues.  RPh encouraged her to drink plenty of fluids over the next few hours.
Age: 73.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site warmth, Mobility decreased, Pain in extremity, Tenderness
Clinical narrative: pt developed severe pain to the left upper extremity from her shoulder to her elbow that was very sensitive to light touch;  This happened on day 1, I saw her on day 3.  On day 3 she had developed a red  area that surrounded the site of the injection and was warm to touch.  The sensitive area had narrowed down to this red area and the rest of the arm had improved;  patient said that she could not lift her arm beyond shoulder level for 2 days.  it was improving at the time I saw her
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Decreased appetite, Diarrhoea, Fatigue, Influenza like illness
Clinical narrative: Pt. symptoms, flu like, achy, diarrhea, tried, no energy, fever, nausea, no appetite, malaise. for 3-5 days from each does  Second Dosage - given Nov. 4th Wed. 2:30 pm central
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Nausea, Pain, Pyrexia
Clinical narrative: Pt. symptoms, flu like, achy, diarrhea, tried, no energy, fever, nausea, no appetite, malaise. for 3-5 days from each does  Second Dosage - given Nov. 4th Wed. 2:30 pm central
Age: 68.0
Sex: F
Vaccine: FLUA4
Symptoms: Blood culture negative, Chronic lymphocytic leukaemia, Computerised tomogram thorax abnormal, Fatigue, Influenza virus test negative
Clinical narrative: Fatigue started 2 days after the shot.  In another day or two, I got a fever.  The fever was intermittent throughout the day, but I had a fever every day from  09/27/20 - 10/13/20.   (Part of that time, from 10/10/20 -10/17/20, I was hospitalized and receiving antibiotics.)
Age: 68.0
Sex: F
Vaccine: FLUA4
Symptoms: Magnetic resonance imaging normal, Magnetic resonance imaging whole body, Pulmonary embolism, Pyrexia, SARS-CoV-2 test negative
Clinical narrative: Fatigue started 2 days after the shot.  In another day or two, I got a fever.  The fever was intermittent throughout the day, but I had a fever every day from  09/27/20 - 10/13/20.   (Part of that time, from 10/10/20 -10/17/20, I was hospitalized and receiving antibiotics.)
Age: 68.0
Sex: F
Vaccine: FLUA4
Symptoms: White blood cell count increased
Clinical narrative: Fatigue started 2 days after the shot.  In another day or two, I got a fever.  The fever was intermittent throughout the day, but I had a fever every day from  09/27/20 - 10/13/20.   (Part of that time, from 10/10/20 -10/17/20, I was hospitalized and receiving antibiotics.)
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: Rash at site of injection, Redness on left thigh, benadyl by mouth
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Nausea, Pyrexia
Clinical narrative: Chills, headache, fever, tiredness. Nausea
Age: 60.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site swelling, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: DESCRIBED BY PATIENT AS SWELLING IN ENTIRE UPPER LEFT ARM, WITH HEAT AND PAIN AT AN 8 ON SCALE OF 1-10 (10 BEING HIGHEST); LASTED 4 DAYS; NO REDNESS  PATIENT TOOK BENADRYL AND TYLENOL
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pain
Clinical narrative: Chills Body ache