chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Hypersensitivity, Rash, Rash papular, Rash pruritic
Clinical narrative: allergic reaction; rash/itchy rash on her arm opposite arm; rash appeared as bumpy round patches; rash appeared as bumpy round patches/number of patches has increased; This case was reported by a consumer via call center representative and described the occurrence of allergic reaction in a 64-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2019-2020 season) for an unknown indication.   On 21st October 2019, the patient received Fluarix Quadrivalent 2019-2020 season (intramuscular). In October 2019, 3 days after receiving Fluarix Quadrivalent 2019-2020 season, the patient experienced itchy rash, papular rash and patchy rash. On an unknown date, the patient experienced allergic reaction. On an unknown date, the outcome of the allergic reaction, itchy rash, papular rash and patchy rash were not recovered/not resolved.   The reporter considered the allergic reaction, itchy rash, papular rash and patchy rash to be related to Fluarix Quadrivalent 2019-2020 season.  Additional case details were reported as follows: The patient received a dose of Fluarix Quadrivalent in an unknown arm. The patient developed an itchy rash on her arm opposite where she got the vaccine.  The rash appeared as bumpy round patches.  The patient happened to have an appointment with her dermatologist a few days later and she was told to just watch the rash.  The rash continued to get worse since the vaccination and it traveled all over her body.  The rash cleared up from one place and reappeared in another place and the number of patches was increased which was very itchy.  The patient saw her dermatologist again for the rash and was told she had an allergic reaction.  She has not had any changes in her diet, medications or supplements, so it was thought that the allergic reaction might be due to Fluarix.  The reporter consented to follow up.
Age: 87.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Redness, a hard lump at the injection site and swelling about 6 inches in diameter below the injection site; Redness, a hard lump at the injection site and swelling about 6 inches in diameter below the injection site; Redness, a hard lump at the injection site and swelling about 6 inches in diameter below the injection site; This spontaneous report was received from a pharmacist referring to a 87-year-old female patient. Her concurrent conditions included hypertension, depression, urinary frequency and incontinence. Concomitant medications included unspecified three blood pressure medications, selective serotonin-reuptake inhibitors and urinary frequency medications. Her historical drugs included Naproxen and Vicodin. She is allergic to Naproxen and Vicodin. Her medical history was not reported.  On 21-NOV-2019, the patient was vaccinated with second dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) intramuscularly in the right deltoid arm for prophylaxis (lot # R033343 and expiration date: 03-AUG-2020; strength, dose, and unit were not reported). On the next day (reported as 22-NOV-2019), the patient experienced redness (injection site erythema), a hard lump at the injection site (injection site mass) and swelling about six inches in diameter below the injection site (peripheral swelling). The patient sought medical attention and was treated with ice and Tylenol. On 23-NOV-2019, the redness, lump and swelling had decreased although the skin was very loose below the injection site where the swelling had been. No lab diagnostics/studies were performed. It was unknown if the patient had fully recovered. The patient also denied any adverse reaction with her first dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) administered on an unspecified date prior to age 65. The outcome of the events was recovering/resolving as on 23-NOV-2019. Causality assessment of the events with the suspect therapy was not provided.
Age: 87.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site swelling
Clinical narrative: Redness, a hard lump at the injection site and swelling about 6 inches in diameter below the injection site; Redness, a hard lump at the injection site and swelling about 6 inches in diameter below the injection site; Redness, a hard lump at the injection site and swelling about 6 inches in diameter below the injection site; This spontaneous report was received from a pharmacist referring to a 87-year-old female patient. Her concurrent conditions included hypertension, depression, urinary frequency and incontinence. Concomitant medications included unspecified three blood pressure medications, selective serotonin-reuptake inhibitors and urinary frequency medications. Her historical drugs included Naproxen and Vicodin. She is allergic to Naproxen and Vicodin. Her medical history was not reported.  On 21-NOV-2019, the patient was vaccinated with second dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) intramuscularly in the right deltoid arm for prophylaxis (lot # R033343 and expiration date: 03-AUG-2020; strength, dose, and unit were not reported). On the next day (reported as 22-NOV-2019), the patient experienced redness (injection site erythema), a hard lump at the injection site (injection site mass) and swelling about six inches in diameter below the injection site (peripheral swelling). The patient sought medical attention and was treated with ice and Tylenol. On 23-NOV-2019, the redness, lump and swelling had decreased although the skin was very loose below the injection site where the swelling had been. No lab diagnostics/studies were performed. It was unknown if the patient had fully recovered. The patient also denied any adverse reaction with her first dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) administered on an unspecified date prior to age 65. The outcome of the events was recovering/resolving as on 23-NOV-2019. Causality assessment of the events with the suspect therapy was not provided.
Age: 2.0
Sex: M
Vaccine: FLU4
Symptoms: Cough, Erythema, Flushing, Urticaria, Wheezing
Clinical narrative: Child left the office right after vaccination and went to Starbucks with his parents.  While there, approximately 30 min after vaccination, he developed a bad coughing spell and turned red.  Following that he had audible wheezing.  Parents reported he had hives vs. facial flushing.  No medications were given.  He returned to the office and was seen by me approximately 1 hour after vaccination.  At that time he had no rash or wheezing and was no longer coughing.   He was then well until he developed persistent wheezing on 11/28/19.  He was seen by another doctor in our practice on 11/29/19 and was treated with albuterol and prednisolone.  Symptoms and exam had improved on follow-up on 11/30/2019.
Age: 13.0
Sex: F
Vaccine: MMRV
Symptoms: Wrong product administered
Clinical narrative: The patient was given MMRV in stead of MMR and Varicella separately. The patient was 13 years old and should have gotten them separately.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Herpes zoster
Clinical narrative: Developed hand & feet shinles the day after the shot, got chills only the first night. Visited Dr on 11/26/2019. Prescribed Valtrex for 7 days & betamethasone dipropionate cream for external use. returned 12/4/2019 to Doctor's prescribed no further treatment.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Cough, Dysphonia, Headache, Oropharyngeal pain, Rash
Clinical narrative: - Day after shot: headache. Advil relieved it. (Also  had  sore throat and hoarse voice beginning a few hours after shot, but probably unrelated; had slight throat itch day prior.) - 48 hours after shot: headache. Advil relieved it. RASH on chest, stomach and back.  Took 2 Benadryl. Rash was gone the next morning.  (Still have sore throat and cough.) - NOTE:  I had this same reaction to the first dose of Shingles Shot that I had in early Sept. 2019.
Age: 70.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse effects were reported; a 70 year old patient received a dose of PROQUAD; This spontaneous report was received from a vaccine coordinator and refers to a 70-year-old patient. No information regarding patient's concurrent conditions, past medical history, concomitant medications, drug reactions or allergies was provided. On 06-NOV-2019, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (recombinant human albumin) one dose, injection, lot # S002490, expiration date 23-JUL-2020 (exact dose and route of administration were not provided) for prophylaxis. On 06-NOV-2019, the patient experienced product administered to patient of inappropriate age. No adverse effects was reported. The outcome of the event was unknown.
Sex: U
Vaccine: MMRV, UNK
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: No adverse effect; patient received a dose or PROQUAD instead of MMR Il; adult patient received a dose or PROQUAD instead of MMR Il; This spontaneous report was received from a registered nurse referring to an adult patient of unknown age and gender. Information about patient's concurrent condition, medical history, drug allergy/reaction was not reported.   On 25-NOV-2019, an adult patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) therapy type: rHA, lot # R026720, expiration date: 17-MAR-2020 (strength, dose number, route, anatomical location was not reported) for prophylaxis instead of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (wrong product administered and product administered to patient of inappropriate age). Other suspect therapy included sterile diluent (strength, dose, route, lot/batch #, expiration date was not reported). It was also reported that the patient received a dose of varicella virus vaccine live (oka/merck)(VARIVAX) on the same visit (concomitant therapy). No adverse events were reported. No product quality complaint was involved.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse symptoms reported.; the patient was "inadvertently administered a dose of VARIVAX and a dose of PROQUAD at the same office visit on 11/22/19."; This spontaneous report was received from a medical assistance referring to a 15 months old patient of unknown gender. Concomitant therapies included sterile diluent.  Information about pertinent medical history, drug reactions or allergies was not provided.         On 22-NOV-2019, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) (lot # S022758, expiration date 22-JUL-2021; dosage detail, strength and route were not reported) and measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (recombinant Human albumin (rHA)) (lot # S027464, expiration date 02-MAR-2021; dosage detail, strength and route were not reported) for prophylaxis at the same office visit (inappropriate schedule of product administration).  No adverse effects were reported.
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: No symptoms; an expired dose of GARDASIL 9 was administered to a patient; This spontaneous report as received from an office menager refers to a patient of unknown age and gender. No information on patient's pertinent medical history, drug reactions or allergies and concomitant medications was provided.      On 20-NOV-2019, the patient was vaccinated with an expired dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # N007931, expiration date 17-NOV-2019) (dose, route of administration and anatomical location were not provided) for prophylaxis.        The patient experienced no symptoms.
Sex: F
Vaccine: VARZOS
Symptoms: Chronic obstructive pulmonary disease, Condition aggravated, Cough, Dyspnoea, Herpes zoster
Clinical narrative: acute hypoxemic respiratory failure; hypeoxemic; multifocal pneumonia; COPD exacerbation; shingles.; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. The patient's medical history, concurrent condition and concomitant medication were not reported.      On or around 12-JAN-2017 the patient was inoculated with zoster vaccine live (ZOSTAVAX) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster).        Shortly after receiving zoster vaccine live (ZOSTAVAX), the patient suffered severe cough and shortness of breath. The patient was hospitalized and diagnosed with acute hypoxemic respiratory failure, multifocal pneumonia and chronic obstructive pulmonary disease (COPD) exacerbation. Shortly after hospitalization, the patient suffered from a severe rash on her chest and right flank. The patient was diagnosed with shingles. As a direct and proximate result of defective zoster vaccine live (ZOSTAVAX), the patient's symptoms have resulted in physical limitations not present prior to the vaccination. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries (disability) Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), the patient 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 outcome of the events was not resolved. The causality assessment was related. The reporter considered the events to be disabling.   Upon internal review, acute hypoxemic respiratory failure and multifocal pneumonia were determined to be medically significant.  Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Pneumonia, Rash, Respiratory failure
Clinical narrative: acute hypoxemic respiratory failure; hypeoxemic; multifocal pneumonia; COPD exacerbation; shingles.; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. The patient's medical history, concurrent condition and concomitant medication were not reported.      On or around 12-JAN-2017 the patient was inoculated with zoster vaccine live (ZOSTAVAX) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster).        Shortly after receiving zoster vaccine live (ZOSTAVAX), the patient suffered severe cough and shortness of breath. The patient was hospitalized and diagnosed with acute hypoxemic respiratory failure, multifocal pneumonia and chronic obstructive pulmonary disease (COPD) exacerbation. Shortly after hospitalization, the patient suffered from a severe rash on her chest and right flank. The patient was diagnosed with shingles. As a direct and proximate result of defective zoster vaccine live (ZOSTAVAX), the patient's symptoms have resulted in physical limitations not present prior to the vaccination. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries (disability) Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), the patient 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 outcome of the events was not resolved. The causality assessment was related. The reporter considered the events to be disabling.   Upon internal review, acute hypoxemic respiratory failure and multifocal pneumonia were determined to be medically significant.  Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No other adverse effects were reported in the patient; a patient received an improperly stored dose of PROQUAD; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not provided.   On 05-NOV-2019 the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (lot # S012472 with expiration date 20-OCT-2020; dose, frequency and route of administration were not reported) for prophylaxis. No other adverse effects were reported in the patient.   The temperature excursion was ranged from 6 Fahrenheit Degree to 14 Fahrenheit Degree (-14 Celsius Degree to -10 Celsius Degree) (7.9F) for 20 minutes. The previous temperature excursion was ranged from 6 Fahrenheit Degree to 14 Fahrenheit Degree (-14 Celsius Degree to -10 Celsius Degree) (8.2F) for 40 minutes. Data logger was involved.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effects.; patient received a dose of PROQUAD on 12/2/2019 that was improperly stored; This spontaneous report was received from a physician referring to a patient of unknown age and gender. Information about medical history and concurrent conditions was not provided. Concomitant therapy included sterile diluent.     On 02-DEC-2019, the patient was vaccinated with a dose of improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # S017251, expiration date 01-DEC-2020; strength, dose, route, and were not reported) for prophylaxis (improper storage of product in use). Temperature excursions ranged 47 degrees Fahrenheit to 77 degrees Fahrenheit (59.9 degrees Fahrenheit) for 24 hours, 15 degrees Fahrenheit to 46 degrees Fahrenheit for 9 hours and 30 minutes and 6 degrees Fahrenheit to 14 degrees Fahrenheit for 6 hours and 30 minutes. There were previous temperature excursions. On 10-SEP-2019, 6 degrees Fahrenheit to 14 degrees Fahrenheit (7.7 degrees Fahrenheit) for 30 minutes. On 13-SEP-2019, 6 degrees Fahrenheit to 14 degrees Fahrenheit (14 degrees Fahrenheit) for 1 hour and 10 minutes. On 22-SEP-2019, 6 degrees Fahrenheit to 14 degrees Fahrenheit (11.7 degrees Fahrenheit) for 2 hours and 5 minutes. Data logger was involved. No additional adverse effects were reported.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No other adverse effects were reported in the patient; a patient received an expired dose of MMR II; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. Information about medical history, concurrent conditions and concomitant therapies was not provided.  On 25-NOV-2019, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (albumin status of rHA (recombinant human albumin)) (M-M-R II) (lot # N032750, expiration date 20-NOV-2019; strength, dose and route were not reported) for prophylaxis (expired vaccine used). No other adverse effects were reported in the patient.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Inappropriate schedule of product administration, No adverse event, Wrong product administered
Clinical narrative: No adverse symptoms reported; PROQUAD was mistaken for MMRII and administered to a patient along with VARIVAX; PROQUAD was mistaken for MMRII and administered to a patient along with VARIVAX; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not provided.  On 02-DEC-2019 the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (lot # S013714 with expiration date 01-NOV-2020, for prophylaxis; dose, frequency and route of administration were not reported) which was mistaken for measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (for prophylaxis; dose, frequency, route of administration, lot# and expiration date were not reported) along with varicella virus vaccine live (oka/merck)(VARIVAX) (for prophylaxis; dose, frequency, route of administration, lot# and expiration date were not reported) (wrong product administered and inappropriate schedule of product administration). No adverse symptoms were reported.
Sex: M
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: chicken pox; was supposed to get his 2nd dose in july; This spontaneous report as received from a nurse via a company representative refers to a male patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported.   On an unknown date in May (year not specified), the patient was vaccinated with first dose of varicella virus vaccine live (oka/merck)(VARIVAX) (strength, dose, lot # and expiry date was not reported) for prophylaxis. On an unknown date (after vaccination), the patient experienced chicken pox (varicella). It was reported that the patient was supposed to get his second dose in July (year not specified), since he had chicken box, he was never given second dose (inappropriate schedule of product administration). The outcome of varicella was unknown. The relatedness between the event and the suspect therapy was not provided.
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Fatigue, Genital rash, Pruritus, Rash
Clinical narrative: Lower back pain; Fatigue; Vaginal sores/rash; Vaginal sores/rash; Abdominal rash/itching; Abdominal itching; This case was reported by a consumer via call center representative and described the occurrence of low back pain in a adult female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Concurrent medical conditions included autoimmune disorder and eosinophilic asthma. Concomitant products included cortisone (non-proprietary) (Cortisone Cream).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced low back pain, fatigue, vaginal lesion, genital rash, rash and pruritus. On an unknown date, the outcome of the low back pain, fatigue, vaginal lesion, genital rash, rash and pruritus were recovering/resolving.   It was unknown if the reporter considered the low back pain, fatigue, vaginal lesion, genital rash, rash and pruritus to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not provided. This case was received from GlaxoSmithKline response center. The patient received 2 doses of Shinges vaccine and was not sure if that was causing her symptoms of abdominal rash, vaginal sores and rash, fatigue and lower back pain. Consumer was referred to see her Health care professional for medical advice. The reporter consented to follow-up. The outcome of the event was captured according to the xml sheet provided.
Sex: F
Vaccine: VARZOS
Symptoms: Vaginal lesion
Clinical narrative: Lower back pain; Fatigue; Vaginal sores/rash; Vaginal sores/rash; Abdominal rash/itching; Abdominal itching; This case was reported by a consumer via call center representative and described the occurrence of low back pain in a adult female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Concurrent medical conditions included autoimmune disorder and eosinophilic asthma. Concomitant products included cortisone (non-proprietary) (Cortisone Cream).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced low back pain, fatigue, vaginal lesion, genital rash, rash and pruritus. On an unknown date, the outcome of the low back pain, fatigue, vaginal lesion, genital rash, rash and pruritus were recovering/resolving.   It was unknown if the reporter considered the low back pain, fatigue, vaginal lesion, genital rash, rash and pruritus to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not provided. This case was received from GlaxoSmithKline response center. The patient received 2 doses of Shinges vaccine and was not sure if that was causing her symptoms of abdominal rash, vaginal sores and rash, fatigue and lower back pain. Consumer was referred to see her Health care professional for medical advice. The reporter consented to follow-up. The outcome of the event was captured according to the xml sheet provided.
Sex: U
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Broke out in hives; This case was reported by a consumer and described the occurrence of hives in a patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2019-2020 season) for prophylaxis.   On an unknown date, the patient received Fluarix Quadrivalent 2019-2020 season at an unknown dose. On an unknown date, less than 2 years after receiving Fluarix Quadrivalent 2019-2020 season, the patient experienced hives. On an unknown date, the outcome of the hives was unknown.   It was unknown if the reporter considered the hives to be related to Fluarix Quadrivalent 2019-2020 season.  Additional details were provided as follows: The age at vaccination was not provided. The patient was wondering if they could get an ingredient list for the Fluarix flu shot and said that they didn't need all of them. The patient broke out in hives and was told the shots were latex and preservative free. The patient was trying to narrow down on what could have reacted to and hopes this wasn't an inconvenience.
Sex: U
Vaccine: UNK, UNK
Symptoms: Aphonia, Cough, Malaise, Mental disorder
Clinical narrative: Sick; Cough; Losing my voice; Going to break down; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2019-2020 season) for prophylaxis.   Co-suspect products included PERTUSSIS TOXOID (WHOOPING COUGH VACCINE) for prophylaxis.   In August 2019, the patient received Influenza vaccine Quadrivalent 2019-2020 season and WHOOPING COUGH VACCINE. On an unknown date, less than 4 months after receiving Influenza vaccine Quadrivalent 2019-2020 season, the patient experienced sickness, cough, loss of voice and nervous breakdown. On an unknown date, the outcome of the sickness was not recovered/not resolved and the outcome of the cough, loss of voice and nervous breakdown were unknown.   It was unknown if the reporter considered the sickness, cough, loss of voice and nervous breakdown to be related to Influenza vaccine Quadrivalent 2019-2020 season.  Additional case details were reported as follows: The age at vaccination was not reported. The patient was sick with cough and losing his or her voice.  The patient was going to break down and seek doctor advice because it has been long time since the patient was sick. It was unknown if the reporter considered the sickness, cough, loss of voice and nervous breakdown to be related to whooping cough vaccine.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: red arm; Sore arm where the shot was given; This case was reported by a consumer via sales rep and described the occurrence of injection site erythema in a 74-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th August 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced injection site erythema and injection site pain. On an unknown date, the outcome of the injection site erythema and injection site pain were unknown.   It was unknown if the reporter considered the injection site erythema and injection site pain to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The patient received Shingrix on left arm and experienced reactions that red and sore left arm where the shot was given. The reporter consented to follow up. This case has been linked with the case US2019AMR211822, for 2nd dose.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache
Clinical narrative: shivering; headache; fatigue; This case was reported by a consumer via call center representative and described the occurrence of shivering in an unspecified number of  patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced shivering, headache and fatigue. On an unknown date, the outcome of the shivering, headache and fatigue were unknown.   It was unknown if the reporter considered the shivering, headache and fatigue to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The reporter did not consent to follow-up. The reporter did not wish to participate in a safety report, she just gave a general statement about her friend's experience with Shingrix.  There were no other details. For tolerance of 2nd dose, refer linked case US2019215483.
Age: 26.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site pain, Product administered at inappropriate site, Shoulder injury related to vaccine administration
Clinical narrative: Extreme pain at the injection site; Difficulty raising arm  and lifting objects.; Sirva; Vaccine administered at inappropriate site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 26-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2019-2020 season) (batch number E975Y, expiry date 25th June 2019) for prophylaxis.   On 17th October 2019, the patient received FluLaval Quadrivalent 2019-2020 season. On 17th October 2019, less than a day after receiving FluLaval Quadrivalent 2019-2020 season, the patient experienced injection site pain, injected limb mobility decreased, shoulder injury related to vaccine administration and vaccine administered at inappropriate site. On an unknown date, the outcome of the injection site pain, injected limb mobility decreased and vaccine administered at inappropriate site were recovering/resolving and the outcome of the shoulder injury related to vaccine administration was unknown.   It was unknown if the reporter considered the injection site pain, injected limb mobility decreased and shoulder injury related to vaccine administration to be related to FluLaval Quadrivalent 2019-2020 season.  Additional details were provided as follows: The age at vaccination was not reported. The patient reported extreme pain at the injection site which remain till the time of reporting. The patient has difficulty raising his arm and lifting objects. The patient was administered the vaccine the same day and was given by the same nurse. The reporter suspects the vaccine was administered too high on the deltoid resulting in symptoms that occur with sirva, that was the shoulder injury which was related to vaccine administration. The reporter consented to follow up. This case was one of the 9 case reported by the same reporter.
Age: 26.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site pain, Product administered at inappropriate site, Shoulder injury related to vaccine administration
Clinical narrative: extreme pain at the injection site; difficulty raising arm and lifting objects; Sirva; reporter suspects the vaccine was administered too high on the deltoid; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 26-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2019-2020 season) (batch number E975Y, expiry date 25th June 2020) for prophylaxis.   On 17th October 2019, the patient received FluLaval Quadrivalent 2019-2020 season (intramuscular). On 17th October 2019, less than a day after receiving FluLaval Quadrivalent 2019-2020 season, the patient experienced injection site pain, injected limb mobility decreased, shoulder injury related to vaccine administration and vaccine administered at inappropriate site. On an unknown date, the outcome of the injection site pain, injected limb mobility decreased and vaccine administered at inappropriate site were recovering/resolving and the outcome of the shoulder injury related to vaccine administration was unknown.   It was unknown if the reporter considered the injection site pain, injected limb mobility decreased and shoulder injury related to vaccine administration to be related to FluLaval Quadrivalent 2019-2020 season.  Additional details were provided as follows: The age at vaccination was not reported. The patient reported extreme pain at the injection site which remain till the time of reporting. The patient has difficulty raising his arm and lifting objects. The patient was administered the vaccine the same day and was given by the same nurse. The reporter suspects the vaccine was administered too high on the deltoid resulting in symptoms that occur with sirva, that was the shoulder injury which was related to vaccine administration. The reporter consented to follow up. This case was one of the 9 case reported by the same reporter.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site pain, Product administered at inappropriate site, Shoulder injury related to vaccine administration
Clinical narrative: extreme pain at the injection site; difficulty raising arm and lifting objects; Sirva; vaccine was administered too high on the deltoid resulting in symptoms that occur with Sirva; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 53-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2019-2020 season) (batch number E975Y, expiry date 25th June 2020) for prophylaxis.   On 17th October 2019, the patient received FluLaval Quadrivalent 2019-2020 season (intramuscular). On 17th October 2019, less than a day after receiving FluLaval Quadrivalent 2019-2020 season, the patient experienced injection site pain, injected limb mobility decreased, shoulder injury related to vaccine administration and vaccine administered at inappropriate site. On an unknown date, the outcome of the injection site pain, injected limb mobility decreased and vaccine administered at inappropriate site were recovering/resolving and the outcome of the shoulder injury related to vaccine administration was unknown.   It was unknown if the reporter considered the injection site pain, injected limb mobility decreased and shoulder injury related to vaccine administration to be related to FluLaval Quadrivalent 2019-2020 season.  Additional details were provided as follows: The age at vaccination was not reported. The patient reported extreme pain at the injection site which remain till the time of reporting. The patient has difficulty raising his arm and lifting objects. The patient was administered the vaccine the same day and was given by the same nurse. The reporter suspects the vaccine was administered too high on the deltoid resulting in symptoms that occur with sirva, that was the shoulder injury which was related to vaccine administration. The reporter consented to follow up. This case was one of the 9 case reported by the same reporter.
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site pain, Product administered at inappropriate site, Shoulder injury related to vaccine administration
Clinical narrative: extreme pain at injection site; difficulty raising arm and lifting objects; sirva; vaccine was administered too high on the deltoid resulting in symptoms that occur with Sirva; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 47-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2019-2020 season) (batch number E975Y, expiry date 25th June 2020) for prophylaxis.   On 17th October 2019, the patient received FluLaval Tetra 2019-2020 season. On 17th October 2019, less than a day after receiving FluLaval Tetra 2019-2020 season, the patient experienced injection site pain, injected limb mobility decreased, shoulder injury related to vaccine administration and vaccine administered at inappropriate site. On an unknown date, the outcome of the injection site pain and injected limb mobility decreased were not recovered/not resolved and the outcome of the shoulder injury related to vaccine administration and vaccine administered at inappropriate site were unknown.   It was unknown if the reporter considered the injection site pain, injected limb mobility decreased and shoulder injury related to vaccine administration to be related to FluLaval Tetra 2019-2020 season.  Additional case details were reported as follows: The patient had extreme pain at the injection site.  The patient has difficulty raising his arm and lifting objects.  The reporter suspects the vaccine was administered too high on the deltoid, which led to vaccine administered at inappropriate site. This resulted in symptoms that occur with SIRVA (shoulder injury related to vaccine administration). The reporter consented to follow up. This is 1 of 8 cases reported by same reporter.
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site pain, Product administered at inappropriate site, Shoulder injury related to vaccine administration
Clinical narrative: Extreme pain at the injection site; difficulty raising arm and lifting objects; SIRVA; vaccine was administered too high on the deltoid resulting in symptoms that occur with Sirva; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 44-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2019-2020 season) (batch number E975Y, expiry date 25th June 2020) for prophylaxis.   On 17th October 2019, the patient received FluLaval Tetra 2019-2020 season (intramuscular). On 17th October 2019, less than a day after receiving FluLaval Tetra 2019-2020 season, the patient experienced injection site pain, injected limb mobility decreased, shoulder injury related to vaccine administration and vaccine administered at inappropriate site. On an unknown date, the outcome of the injection site pain and injected limb mobility decreased were not recovered/not resolved and the outcome of the shoulder injury related to vaccine administration and vaccine administered at inappropriate site were unknown.   It was unknown if the reporter considered the injection site pain, injected limb mobility decreased and shoulder injury related to vaccine administration to be related to FluLaval Tetra 2019-2020 season.  Additional case details were reported as follows: The patient received a dose of FluLaval Tetra in an unknown deltoid. The patient had extreme pain at the injection site. The patient had difficulty raising his arm and lifting objects.  The reporter suspects the vaccine was administered too high on the deltoid, which led to vaccine administered at inappropriate site. This resulted in symptoms that occur with Sirva (shoulder injury related to vaccine administration).  The reporter consented to follow up. This is 1 of 9 linked cases, reported by same reporter.
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site pain, Product administered at inappropriate site, Shoulder injury related to vaccine administration
Clinical narrative: extreme pain at the injection site; difficulty raising arm and lifting objects; SIRVA; vaccine was administered too high on the deltoid resulting in symptoms that occur with Sirva; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 45-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2019-2020 season) (batch number E975Y, expiry date 25th June 2020) for prophylaxis.   On 17th October 2019, the patient received FluLaval Tetra 2019-2020 season. On 17th October 2019, less than a day after receiving FluLaval Tetra 2019-2020 season, the patient experienced injection site pain, injected limb mobility decreased, shoulder injury related to vaccine administration and vaccine administered at inappropriate site. On an unknown date, the outcome of the injection site pain and injected limb mobility decreased were not recovered/not resolved and the outcome of the shoulder injury related to vaccine administration and vaccine administered at inappropriate site were unknown.   It was unknown if the reporter considered the injection site pain, injected limb mobility decreased and shoulder injury related to vaccine administration to be related to FluLaval Tetra 2019-2020 season.  Additional case details were reported as follows: The patient received a dose of FluLaval Tetra in right deltoid. The patient had extreme pain at the injection site. The patient had difficulty raising his arm and lifting objects.  The reporter suspects the vaccine was administered too high on the deltoid, which led to vaccine administered at inappropriate site. This resulted in symptoms that occur with Sirva (shoulder injury related to vaccine administration).  The reporter consented to follow up. This is 1 of 9 linked cases, reported by same reporter.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site pain, Product administered at inappropriate site, Shoulder injury related to vaccine administration
Clinical narrative: extreme pain at the injection site; difficulty raising arm and lifting objects; sirva; vaccine was administered too high on the deltoid resulting in symptoms that occur with Sirva.; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 61-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2019-2020 season) (batch number E975Y, expiry date 25th June 2020) for prophylaxis.   On 17th October 2019, the patient received FluLaval Tetra 2019-2020 season (intramuscular). On 17th October 2019, less than a day after receiving FluLaval Tetra 2019-2020 season, the patient experienced injection site pain, injected limb mobility decreased, shoulder injury related to vaccine administration and vaccine administered at inappropriate site. On an unknown date, the outcome of the injection site pain and injected limb mobility decreased were not recovered/not resolved and the outcome of the shoulder injury related to vaccine administration and vaccine administered at inappropriate site were unknown.   It was unknown if the reporter considered the injection site pain, injected limb mobility decreased and shoulder injury related to vaccine administration to be related to FluLaval Tetra 2019-2020 season.  Additional case details were reported as follows: The patient received a dose of FluLaval Tetra in an unknown deltoid. The patient had extreme pain at the injection site. The patient had difficulty raising his arm and lifting objects.  The reporter suspects the vaccine was administered too high on the deltoid, which led to vaccine administered at inappropriate site. This resulted in symptoms that occur with Sirva (shoulder injury related to vaccine administration).  The reporter consented to follow up. This is 1 of 9 linked cases, reported by same reporter.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Cough, Headache, Influenza like illness, Magnetic resonance imaging normal, Malaise
Clinical narrative: Flu-like symptoms; Nasal drip caused her to cough a lot; Felt so poorly; Headache; Nasal drip, including a runny nose and post-nasal drip; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16th October 2019, the patient received the 1st dose of Shingrix (intramuscular). In October 2019, less than a week after receiving Shingrix, the patient experienced cough and feeling unwell. On 17th October 2019, the patient experienced influenza-like symptoms, headache and runny nose. On 19th October 2019, the outcome of the influenza-like symptoms was recovered/resolved. On 21st November 2019, the outcome of the feeling unwell was recovering/resolving. On an unknown date, the outcome of the headache, runny nose and cough were recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms, headache, runny nose, cough and feeling unwell to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix intramuscularly. On 17th October 2019, 1 day after vaccination with Shingrix, the patient experienced flu-like symptoms,  headache and nasal drip, including a runny nose and post-nasal drip, that lasted for 5-6 weeks.  The nasal drip caused her to cough a lot as well.  On 21st November 2019, the patient started feeling better. She saw her doctor for the headache and nasal drip and had an MRI done, but nothing showed on the scan.  She never got sick and was concerned about how she felt so poorly for so long. The reporter consented to follow-up.      Lab Comments: On an unknown date, in 2019, the patient had an MRI done.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Rhinorrhoea, Upper-airway cough syndrome
Clinical narrative: Flu-like symptoms; Nasal drip caused her to cough a lot; Felt so poorly; Headache; Nasal drip, including a runny nose and post-nasal drip; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16th October 2019, the patient received the 1st dose of Shingrix (intramuscular). In October 2019, less than a week after receiving Shingrix, the patient experienced cough and feeling unwell. On 17th October 2019, the patient experienced influenza-like symptoms, headache and runny nose. On 19th October 2019, the outcome of the influenza-like symptoms was recovered/resolved. On 21st November 2019, the outcome of the feeling unwell was recovering/resolving. On an unknown date, the outcome of the headache, runny nose and cough were recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms, headache, runny nose, cough and feeling unwell to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix intramuscularly. On 17th October 2019, 1 day after vaccination with Shingrix, the patient experienced flu-like symptoms,  headache and nasal drip, including a runny nose and post-nasal drip, that lasted for 5-6 weeks.  The nasal drip caused her to cough a lot as well.  On 21st November 2019, the patient started feeling better. She saw her doctor for the headache and nasal drip and had an MRI done, but nothing showed on the scan.  She never got sick and was concerned about how she felt so poorly for so long. The reporter consented to follow-up.      Lab Comments: On an unknown date, in 2019, the patient had an MRI done.