chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Peripheral swelling
Clinical narrative: arm swelled; arm turned bright red; This case was reported by a consumer via other manufacturer and described the occurrence of swelling arm in a 78-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included iron (Feosol).   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced swelling arm and erythema of extremities. On an unknown date, the outcome of the swelling arm and erythema of extremities were unknown.   It was unknown if the reporter considered the swelling arm and erythema of extremities to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported but it could be 77 or 78 years. The patient reportedly experienced her arm swelled and turned bright red. No other information was available. The reporter had not consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Malaise, Pain in extremity, Peripheral swelling
Clinical narrative: malaise; severe swelling in entire arm; soreness; This case was reported by a pharmacist via call center representative and described the occurrence of swelling arm in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced swelling arm, pain in arm and malaise. On an unknown date, the outcome of the swelling arm and pain in arm were recovered/resolved and the outcome of the malaise was unknown.   It was unknown if the reporter considered the swelling arm, pain in arm and malaise to be related to Shingrix.  Additional information received were as follows: The age at vaccination was not reported. The patient personal experience with shingrix was a pretty severe swelling in my entire arm and soreness for about 12 days.   The patient also had some malaise. The patient reported that if they had a patient who exhibits a response like the patient experienced what was their  recommendation give 2nd dose or not. For tolerance to 2nd dose refer linked case US2019AMR146574.
Sex: F
Vaccine: VARZOS
Symptoms: Death
Clinical narrative: patient passed away; This case was reported by a other health professional via patient support programs and described the occurrence of unknown cause of death in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On 17th July 2019, less than 2 years after receiving Shingrix, the patient experienced unknown cause of death (serious criteria death and GSK medically significant). On 17th July 2019, the outcome of the unknown cause of death was fatal. The patient died on 17th July 2019. The reported cause of death was unknown cause of death.   It was unknown if the reporter considered the unknown cause of death to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. It was reported that the patient passes away on 17th July 2019 by unknown cause. The reporter did not agree to follow up.; Reported Cause(s) of Death: Death NOS
Age: 56.0
Sex: F
Vaccine: HEPA, UNK, UNK
Symptoms: Oral herpes
Clinical narrative: fever blister; This case was reported by a consumer via call center representative and described the occurrence of fever blister in a 56-year-old female patient who received Hepatitis A vaccine for prophylaxis.   Co-suspect products included MEASLES MUMPS RUBELLA VACCINE for prophylaxis and TYPHUS VACCINE for prophylaxis.   The patient's past medical history included fever blister.   On 7th August 2019, the patient received Hepatitis A vaccine, MEASLES MUMPS RUBELLA VACCINE and TYPHUS VACCINE. On 8th August 2019, 1 days after receiving Hepatitis A vaccine, the patient experienced fever blister. The patient was treated with valaciclovir hydrochloride (Valtrex). On an unknown date, the outcome of the fever blister was recovering/resolving.   It was unknown if the reporter considered the fever blister to be related to Hepatitis A vaccine.  Additional details were provided as follows: The patient stated that she received the Hepatitis A vaccine and developed a fever blister. The patient was taking Valtrex for the fever blister. The patient did not consent to follow up. The patient did not have any additional information.
Age: 25.0
Sex: F
Vaccine: HEPA
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Left upper arm erythematous with swelling spreading down arm. Concern for cellulitis-treated with Cefalexin.    Received two vaccines in same arm.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Dizziness- occurred about 30 minutes after vaccination administration and went away within an hour Chills- went away within 24 hours of vaccine administration Raised bump- applied warm compress/heating pad initially to injection site and went away within 72 hours Sore arm- applied warm compress/heating pad initially to injection site and went away within 72 hours Low grade fever- went away within 24 hours of vaccine administration
Age: 19.0
Sex: M
Vaccine: MENB
Symptoms: Chills, Feeling cold, Headache, Mass, Pain
Clinical narrative: Patient called the clinic today, 8-5-19, stating on the evening of 8-1-19, several hours after receiving his 2nd dose of Bexero Men B he began feeling cold, experiencing body aches, and began to get a mild headache. Patient states at that time he took one Tylenol and began feeling better. Patient states the next morning, Friday 8-2-19, he woke up with body aches and a headache so he took another Tylenol. Patient states that he continued with body aches and a headache off and on on Saturday but Sunday he felt better all day. Patient states that today, 8-5-19, he woke up with body aches and "feels a lump behind my sternum that can only be felt on the inside" and coughing up phlegm. Patient denies symptoms or illness prior to vaccine administration on 8-1-19. Patient denies averse reaction to any previous vaccine including 1st Bexero Men B dose.       Patient unable to say if he has a fever accompanying the body aches and chills.
Age: 19.0
Sex: M
Vaccine: MENB
Symptoms: Productive cough
Clinical narrative: Patient called the clinic today, 8-5-19, stating on the evening of 8-1-19, several hours after receiving his 2nd dose of Bexero Men B he began feeling cold, experiencing body aches, and began to get a mild headache. Patient states at that time he took one Tylenol and began feeling better. Patient states the next morning, Friday 8-2-19, he woke up with body aches and a headache so he took another Tylenol. Patient states that he continued with body aches and a headache off and on on Saturday but Sunday he felt better all day. Patient states that today, 8-5-19, he woke up with body aches and "feels a lump behind my sternum that can only be felt on the inside" and coughing up phlegm. Patient denies symptoms or illness prior to vaccine administration on 8-1-19. Patient denies averse reaction to any previous vaccine including 1st Bexero Men B dose.       Patient unable to say if he has a fever accompanying the body aches and chills.
Age: 30.0
Sex: F
Vaccine: TD
Symptoms: Abdominal pain upper, Arthralgia, Chills, Myalgia
Clinical narrative: I received the vaccine in the late afternoon and within a few hours I had muscle soreness across my upper back, arms, and legs, as well as widespread joint pain. Later in the evening I had chills. The following day I had stomach cramps. The joint pain lasted for a few weeks.
Age: 84.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash erythematous
Clinical narrative: Patient stated that he got a shingles rash from the Shingrix. Patient will follow up with physician. I reviewed the rash. It resembles a sun rash. I am uncertain of what causes the rash.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Discomfort, Fatigue, Injection site extravasation, Injection site pain, Myalgia
Clinical narrative: Little reaction to first Shingrix dose but major reaction to second dose. On the day after, intense muscular pain, extreme fatigue, big red blotch on my arm . Muscular pain continued and on 8/14, I experienced severe muscle pain in the injected arm, with leakage, possibly pus, from the injection site. A rash with raised lesions appeared and was very itchy. The muscle pain lasted two days. The itchiness continues even now, although the lesions have crusted over and are diminishing.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Rash macular, Rash pruritic, Scab
Clinical narrative: Little reaction to first Shingrix dose but major reaction to second dose. On the day after, intense muscular pain, extreme fatigue, big red blotch on my arm . Muscular pain continued and on 8/14, I experienced severe muscle pain in the injected arm, with leakage, possibly pus, from the injection site. A rash with raised lesions appeared and was very itchy. The muscle pain lasted two days. The itchiness continues even now, although the lesions have crusted over and are diminishing.
Age: 20.0
Sex: F
Vaccine: MENB
Symptoms: Dizziness, Headache, Injection site rash, Nausea, Vomiting
Clinical narrative: Patient developed on site rash which has spread in her arm, Feeling dizzied and nausea, vomiting, headaches
Age: 74.0
Sex: M
Vaccine: PNC13
Symptoms: Erythema, Induration, Pyrexia
Clinical narrative: redness and hard on the right arm, slight fever, started a week after vaccine.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Chills, Cold sweat, Feeling cold, Neck pain, Vomiting
Clinical narrative: Pt woke up at 2am freezing, she was vomiting, neck pain, chills, and cold sweats.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Back pain, Chills, Headache, Musculoskeletal pain, Neck pain
Clinical narrative: 12 hours after vaccine given shivers, fever, headache neck, shoulder leg & back pain x 2 days.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: 12 hours after vaccine given shivers, fever, headache neck, shoulder leg & back pain x 2 days.
Sex: U
Vaccine: PNC13
Symptoms: Erythema, Inflammation, Skin warm
Clinical narrative: inflammation; warm; redness; This is a spontaneous report from a contactable pharmacist via a Pfizer sales representative. This pharmacist reported same events for 2 patients. This is 1st of 2 reports. A patient of unspecified age and gender received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13; lot number X62324), via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The pharmacist reported inflammation, warm and redness in a patient previously vaccinated with pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein). The reporter suspected that these reactions were caused by the same lot number (X62324). Outcome of the events was unknown.; Sender's Comments: Linked Report(s) : PR-PFIZER INC-2019345712 same reporter/drug/event, different patient
Sex: U
Vaccine: PNC13
Symptoms: Erythema, Inflammation, Skin warm
Clinical narrative: inflammation; warm; redness; This is a spontaneous report from a contactable pharmacist via a Pfizer sales representative. This pharmacist reported same events for 2 patients. This is 2nd of 2 reports. A patient of unspecified age and gender received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13; lot number X62324), via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The pharmacist reported inflammation, warm and redness in a patient previously vaccinated with pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein). The reporter suspected that these reactions were caused by the same lot number (X62324). Outcome of the events was unknown.; Sender's Comments: Linked Report(s) : PR-PFIZER INC-2019345709 Same reporter/ drug/ event for different patients
Sex: U
Vaccine: MMR
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: no adverse effects; intramuscular route in error; This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies, drug reactions, allergies or medical history provided.   On 24-JUL-2019, the patient received a dose of vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live albumin status rHA (recombinant Human albumin) (M-M-R II) via intramuscular route in error, lot # R036582, expiration date 17-DEC-2020 (exact dose, frequency and anatomical location were not reported) for prophylaxis. Concomitant therapies included sterile diluent (DILUENT MRK). No adverse effects were reported.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: No adverse effect; PROQUAD was administered to patient via intramuscular; This spontaneous report as received from a nurse refers to a patient of unknown demographics. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapy were not reported.  On 09-AUG-2019, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) injection (dose and frequency was not reported) (lot # S00621, expiry date: 06-JUL-2020) via intramuscular for prophylaxis (incorrect route of product administration). No adverse effects were reported. No product quality complaint was involved.  Lot number [S00621] is an invalid lot number for measles, mumps, rubella and varicella (oka-merck) virus vaccine live.
Sex: U
Vaccine: VARZOS
Symptoms: Asthenia, Headache, Myalgia, Pain
Clinical narrative: muscle pain / muscle soreness; headache; feels sore; Feels weak; This case was reported by a consumer and described the occurrence of muscle pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 8th August 2019 09:00, the patient received Shingrix. On 8th August 2019, less than a day after receiving Shingrix, the patient experienced muscle pain and headache. In August 2019, the patient experienced pain and feelings of weakness. On an unknown date, the outcome of the muscle pain, headache, pain and feelings of weakness were unknown.   It was unknown if the reporter considered the muscle pain, headache, pain and feelings of weakness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received dose of Shingrix in the right deltoid. The patient received dose of Shingrix in the pharmacy at 9 am. In the night, on the day of vaccination, the patient experienced muscle soreness and headache. The patient want to know, if he could took Advil gelcaps for muscle pain. The patient did not want to provide date of birth, address and doctor's information. No additional information was provided.
Sex: M
Vaccine: UNK, VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: vaccination failure; shingles; This case was reported by a physician via call center representative and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis and mepolizumab (Nucala) unknown for prophylaxis.   The patient's past medical history included herpes zoster (experienced zoster a few years ago). Previously administered products included Zostavax (received Zostavax, few years ago). Concurrent medical conditions included eosinophilic asthma.   On an unknown date, the patient received the 2nd dose of Shingrix, Shingrix at an unknown dose and Nucala at an unknown dose and frequency. On an unknown date, less than a year after receiving Shingrix and Shingrix and not applicable after starting Nucala, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix. It was unknown if the reporter considered the shingles to be related to Nucala.  Additional details were provided as follows: The age at vaccination was not reported. The patient was nephrologist, who received Nucala 4 to 5 weeks for eosinophilic asthma and his next dose was due on 22nd August 2019. The patient had active shingle and asked to postpone dose of Nucala. The patient was nervous about taking an immunosuppressive, while shingles were active. This case was considered as suspected vaccination failure, since the details regarding time to onset for event and laboratory confirmation for shingles were not provided.
Sex: F
Vaccine: PNC13
Symptoms: Allergy to vaccine, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: drug allergy to pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) in the form of itching, swelling, and warm to touch at injection site; drug allergy to pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) in the form of itching, swelling, and warm to touch at injection site; drug allergy to pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) in the form of itching, swelling, and warm to touch at injection site; drug allergy to pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) in the form of itching, swelling, and warm to touch at injection site; This is a spontaneous report from a contactable physician for a patient enrolled in a Pfizer-sponsored program; this report is in regards to event reported in the patient's past medical history. A 66-year-old female patient received pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) (PREVNAR 13; Lot Number: D58144), via an unspecified route of administration on an unspecified date at single dose for immunization. The medical history and concomitant medications were not reported. The patient experienced drug allergy to pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) in the form of itching, swelling, and warm to touch at injection site. The outcome of the events, drug allergy to pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) in the form of itching, swelling, and warm to touch at injection site, were unknown. The causality assessment between the suspect vaccine and the events were assessed as related.   The batch/lot number for the vaccine, pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein), was not provided and will be requested during follow up, was not provided and will be requested during follow up.  Follow-up (13Aug2019): New information from the contactable physician includes: suspect product data (added lot number and updated coding from pneumococcal 7-valent conjugated vaccine (diphtheria crm197 protein) to pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein)) and causality (related).   No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: MENB, TDAP
Symptoms: Nausea, Syncope
Clinical narrative: Fainted; Nauseous; This is a spontaneous report received from a contactable Other-healthcare professional via a Pfizer sales representative. A 21-year-old female patient received meningococcal group b rlp2086 (TRUMENBA, lot number:  W62470)and diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (TDAP) both via an unspecified route of administration in same arm on an unspecified date at single doses for immunization. The patient's medical history and concomitant medications were not reported. The patient felt nauseous and fainted after vaccination. The outcome of the events was unknown.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: A possible contributory role of the suspect product cannot be excluded for the event faint based on the known safety profile
Sex: U
Vaccine: PNC13
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: has pain in her left arm and cannot raise it; has pain in her left arm and cannot raise it; This is a spontaneous report from a contactable healthcare professional. A 65-year-old patient of an unspecified gender received pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date at a single dose for an immunization. The patient's medical history and concomitant medications were not reported. It was reported that the got the pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein) shot and had pain in her left arm and cannot raise it on an unspecified date. The outcome of the events was unknown.
Sex: U
Vaccine: PNC13
Symptoms: Erythema, Swelling
Clinical narrative: Prevnar 13- Puffiness; Prevnar 13- Redness; Prevnar 13- Swelling; This is a spontaneous report from a contactable pharmacist via Pfizer sales representative. A patient of unspecified age and gender received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13; Solution for injection in pre-filled syringe; lot number and expiration date unknown) via unspecified route of administration on unspecified date at single dose for immunization. Patient medical history and concomitant medications were not reported. On unspecified date, the patient experienced puffiness, redness and swelling. Outcome of the events were unknown.  Information on batch number has been requested.
Sex: F
Vaccine: PNC13
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: having issues with her left arm where she can't raise it, it hurts; This is a spontaneous report from a contactable consumer. A 65-year-old female patient received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein)(PREVNAR 13; lot number X30160, expiration date 01Sep2020) intramuscular, in Aug2019 (a week ago), single dose for immunization. Relevant medical history was reported as none. Concomitant medication included unspecified vitamins. The patient received the vaccine in Aug2019 (a week ago) and the patient had issues with her left arm where the patient can't raise it, it hurts. Outcome of the event was unknown.
Sex: U
Vaccine: MENB, MNQ, TDAP
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Swelling; Pain; Redness; This is a spontaneous report from a contactable Physician via Pfizer sales representative.  An adolescent patient of an unspecified gender received meningococcal group b rlp2086 (TRUMENBA), via an unspecified route of administration in the arm on an unspecified date at single dose for immunization, meningococcal vaccine a/c/y/w conj (dip tox) (MENACTRA), and diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (TDAP), both via an unspecified route of administration at unknown dose for immunisation.  The patient medical history and concomitant medications were not reported. On an unspecified date after use of product the patient experienced a moderate reaction of swelling, pain and redness that spread up towards the neck area. The events were non-serious with outcome of unknown. The information on the batch number has been requested.
Sex: U
Vaccine: MENB, MNQ
Symptoms: Injection site swelling
Clinical narrative: sever swelling at injection site; This is a spontaneous report from contactable nurse via Pfizer Sales Representative. This nurse reported similar events for 3 patients. This is 2nd of 3 reports.  A patient of unspecified age and gender received the first dose of meningococcal group b rlp2086 (TRUMENBA), via an unspecified route of administration on an unspecified date at single dose and meningococcal vaccine a/c/y/w conj (dip tox) (MENACTRA), via an unspecified route of administration on an unspecified date at unknown dose: both vaccines were administered on the same arm for immunisation. The patient medical history and concomitant medications were not reported.  The patient experienced sever swelling at injection site (non-serious) on an unspecified date after use of the product with outcome of unknown.  No follow-up attempts are possible. No further information is expected. Information about batch number cannot be obtained. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-2019352013 same reporter/ drug/ AE, different patient.;US-PFIZER INC-2019351994 same reporter/ drug/ AE, different patient.
Sex: U
Vaccine: MENB, MNQ
Symptoms: Injection site swelling
Clinical narrative: Sever swelling at injection site; This is a spontaneous report from a contactable Nurse via Pfizer sales representative. This nurse reported similar events for 3 patients. This is 3rd of 3 reports.   A patient of unspecified age and gender received the first dose of meningococcal group b rlp2086 (TRUMENBA), via an unspecified route of administration on an unspecified date at single dose and meningococcal vaccine a/c/y/w conj (dip tox) (MENACTRA), via an unspecified route of administration on an unspecified date at unknown dose: both vaccines were administered on the same arm for immunisation. The patient medical history and concomitant medications were not reported.  The patient experienced sever swelling at injection site (non-serious) on an unspecified date after use of the product with outcome of unknown.  No follow-up attempts are possible. No further information is expected. Information about batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2019351994 same reporter/ drug/ AE, different patient.;US-PFIZER INC-2019352012 same reporter/ drug/ AE, different patient.
Age: 77.0
Sex: F
Vaccine: UNK, VARZOS
Symptoms: Altered state of consciousness, Fatigue, Hyperhidrosis, Nausea
Clinical narrative: day after vaccination  -- ausust 8th., 2019:  crawled to kitchen, due to fatigue, to get coffee..  experienced nausea, sweating and almost lost consciousness .  this was before eating or drinking anything that morning. ate little food and slept most of the day.  still tired 3 days later.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Rash erythematous
Clinical narrative: Patient states that the day after she received the vaccine she noticed a red rash that started at the injection site and spread around to the back of her arm. She states that it is not itchy and since it's initial appearance it has decreased in size. I recommended she take a Benadryl and continue to monitor it.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Back pain, Nausea, Pain
Clinical narrative: Patient described full body aches and significant nausea lasting about 2 weeks after the vaccination.  Additionally he reports hip / back pain that began 2 days after the vaccine and continues now about 1 month after the vaccine.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Back pain, Fatigue, Full blood count, Headache, Metabolic function test
Clinical narrative: Patient was seen here in this office on the morning of 8/12/19 and had the Menactra and Trumenba vaccines. Later that evening she went to urgent care due to developing symptoms of headache, back pain, fever and fatigue. The patient was not seen here in this office for these symptoms.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Mononucleosis heterophile test, Pyrexia, Urine analysis
Clinical narrative: Patient was seen here in this office on the morning of 8/12/19 and had the Menactra and Trumenba vaccines. Later that evening she went to urgent care due to developing symptoms of headache, back pain, fever and fatigue. The patient was not seen here in this office for these symptoms.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Swelling
Clinical narrative: redness and swelling
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling, Urticaria
Clinical narrative: Patient had redness and swelling of left thigh measuring 5 x6 cm in diameter, thought to be due to inflammation and not infection. Patient also developed hives on chest.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: raised red circle around admin site. very painful. went down with ice.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Decreased appetite, Lip swelling, Pain, Pyrexia
Clinical narrative: Vomiting that night with stomach pain, fever, achy-- for 48 hours, then upper left lip swelled approx 30 hours later, this lasted 24 hours. Appetite did not return until the third day.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: Vomiting that night with stomach pain, fever, achy-- for 48 hours, then upper left lip swelled approx 30 hours later, this lasted 24 hours. Appetite did not return until the third day.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Mood altered, Pruritus, Rash erythematous, Rash vesicular, Scar
Clinical narrative: approximately 2 weeks after receiving the injection began experiencing very itchy skin and then out break of small red bumps.  Bumps are not filled with fluid but appear very similar to  what I with a mild outbreak of shingles  18 months ago.  when bumps break leave a nasty long lasting scarred area that takes weeks to  heel.  Spots continue to break out, sometime with short  periods of calm but more or less continuously since initial outbreak.  worst area is groin and front of thighs followed by arms and recently small bumps on hands and fingers.  Steroid shot and topical steroid prescription foam seem to help slow but process continues and itching goes up and down the scale.  Scars are very ugly to look at and itching is unpleasant.  Beginning to affect mood  negatively.
Age: 66.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Diarrhoea, Dizziness, Fatigue, Headache, Injection site erythema
Clinical narrative: Within the first 12 hours, I was experiencing dizziness, fatigue, headache, diarrhea, and extreme pain in both vaccination sites.  The following morning, redness and swelling appeared, and the pain increased.  I took 500 mg Tylenol, without results.   By early evening  the swelling increased and patches of what looked like hives appeared above the top injection sight, past the second injection sight and to the area above the elbow.  The patches didn't itch, but were raised and extremely painful and hot to the touch.  Saturday the patches increased and were noticed on the inside of my arm.  The patches were NOT on other places on my body.  I called 24 hour nurse later that day  and she spoke to a Dr. who instructed me to go to their Urgent Care clinic in downtown, believing I had gotten an infection.  The clinic closed before I could get there, so on Sunday morning I planned to go, and could not.   I increased the Tylenol, and  applied cold compresses to the areas and rested, and drank water and electrolyte beverages and by Sunday evening, felt somewhat better.  Today (8/19/19) I am still fatigued BUT 90% of the patches are gone.
Age: 66.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Injection site urticaria, Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Within the first 12 hours, I was experiencing dizziness, fatigue, headache, diarrhea, and extreme pain in both vaccination sites.  The following morning, redness and swelling appeared, and the pain increased.  I took 500 mg Tylenol, without results.   By early evening  the swelling increased and patches of what looked like hives appeared above the top injection sight, past the second injection sight and to the area above the elbow.  The patches didn't itch, but were raised and extremely painful and hot to the touch.  Saturday the patches increased and were noticed on the inside of my arm.  The patches were NOT on other places on my body.  I called 24 hour nurse later that day  and she spoke to a Dr. who instructed me to go to their Urgent Care clinic in downtown, believing I had gotten an infection.  The clinic closed before I could get there, so on Sunday morning I planned to go, and could not.   I increased the Tylenol, and  applied cold compresses to the areas and rested, and drank water and electrolyte beverages and by Sunday evening, felt somewhat better.  Today (8/19/19) I am still fatigued BUT 90% of the patches are gone.
Age: 21.0
Sex: F
Vaccine: TDAP
Symptoms: Hypersensitivity, Rash, Swelling
Clinical narrative: Patient presented covered in a rash on body and felt like she was swelling. She noted onset as 30minutes prior around 3pm Sat 08/17. Patient was sent to ER. Upon following up with patient on 08/18 she stated ER physician assess allergic reaction as being brought on by something that she ate. He noted the vaccine had been administered 2 days prior but felt any reaction around injection site was normal. Patient symptoms had resolved as of Sunday 4pm 08/18.
Age: 1.5
Sex: F
Vaccine: HEPA
Symptoms: Pyrexia, Rash
Clinical narrative: Patients mother called instating that her daughter received a vaccine on 08/05/2019 and started running a fever on 08/07/2019. She had no other symptoms at this time. She was seen in urgent care and advised that fever was most likely from vaccine and teething. On 08/10/2019 the patients mother called back again and advised that the patient had a rash, possible due to an oat exposure. Mom was advised to give benadryl and to come in if pt had and flushing and/or respiratory concerns that developed.  We contacted patients mother the following day and the rash had cleared up a little bit. The patient had no further concerns or problems at this time.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Diarrhoea
Clinical narrative: PATIENT HAS BEEN HAVING 4-6 LOOSE WATERY STOOLS DAILY SINCE VACCINATIONS.  TODAY IS 10TH DAY
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Bedridden, Chills, Dizziness, Fatigue, Impaired work ability
Clinical narrative: shivering; muscle soreness; dizzy; tired; in bed; could not work; This case was reported by a consumer and described the occurrence of shivering in a 64-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 8th August 2019, the patient received Shingrix. On 8th August 2019, several hours after receiving Shingrix, the patient experienced shivering, muscle soreness, dizziness, tiredness, bedridden and inability to work. On an unknown date, the outcome of the shivering, muscle soreness, dizziness, tiredness, bedridden and inability to work were unknown.   It was unknown if the reporter considered the shivering, muscle soreness, dizziness, tiredness, bedridden and inability to work to be related to Shingrix.  Additional case details were reported as follows: This case was reported by the wife of a patient. The patient received his Shingles shot a day before reporting. The patient started last night with shivering and extreme muscle soreness through his entire body.  The patient was also very dizzy and tired to the point he could not work today and was in bed. The reporter did not give permission to follow up.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: shivering; muscle soreness; dizzy; tired; in bed; could not work; This case was reported by a consumer and described the occurrence of shivering in a 64-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 8th August 2019, the patient received Shingrix. On 8th August 2019, several hours after receiving Shingrix, the patient experienced shivering, muscle soreness, dizziness, tiredness, bedridden and inability to work. On an unknown date, the outcome of the shivering, muscle soreness, dizziness, tiredness, bedridden and inability to work were unknown.   It was unknown if the reporter considered the shivering, muscle soreness, dizziness, tiredness, bedridden and inability to work to be related to Shingrix.  Additional case details were reported as follows: This case was reported by the wife of a patient. The patient received his Shingles shot a day before reporting. The patient started last night with shivering and extreme muscle soreness through his entire body.  The patient was also very dizzy and tired to the point he could not work today and was in bed. The reporter did not give permission to follow up.
Age: 18.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Culture urine, Diarrhoea, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Onset of nausea, vomiting, diarrhea at 6:00am- one day after vaccines. Cramping. On exam, no significant tenderness. Normal bowel sounds. 1cm erythema right deltoid. Induration & tenderness, without erythema on left deltoid.
Age: 18.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Muscle spasms, Nausea, Urine analysis, Vomiting
Clinical narrative: Onset of nausea, vomiting, diarrhea at 6:00am- one day after vaccines. Cramping. On exam, no significant tenderness. Normal bowel sounds. 1cm erythema right deltoid. Induration & tenderness, without erythema on left deltoid.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Cerebrovascular accident, Coordination abnormal, Grip strength decreased, Hypoaesthesia, Tremor
Clinical narrative: The same day of vaccination 1. Trembling in the hands 2. Lack of Coordination 3. Patient had no grip 4. Numbness in hands and head  From 3 to 4 weeks after being vaccinated patient had a stroke for which he was hospitalized 45 days
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Pain, Pruritus, Pyrexia, Rash
Clinical narrative: Four hours post: Large welt right arm, lasted three days Four hours post: Flu-like symptoms, fever, body soreness, lasted two days NINE DAYS POST: RASH ON VOLAR LEFT WRIST, VESICULAR, THEN ON POSTERIOR SURFACE LEFT PINNA, THEN DORSUM OF LEFT WRIST, ALSO ITCHING TO LEFT TORSO WITHOUT VISIBLE RASH (appearance consistent with herpetiform eruption)
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash vesicular, Urticaria
Clinical narrative: Four hours post: Large welt right arm, lasted three days Four hours post: Flu-like symptoms, fever, body soreness, lasted two days NINE DAYS POST: RASH ON VOLAR LEFT WRIST, VESICULAR, THEN ON POSTERIOR SURFACE LEFT PINNA, THEN DORSUM OF LEFT WRIST, ALSO ITCHING TO LEFT TORSO WITHOUT VISIBLE RASH (appearance consistent with herpetiform eruption)
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Decreased appetite, Fatigue, Injection site pain, Pain
Clinical narrative: Soreness at area of injection, 102.2F fever, aches all over, weakness, tired, not hungry. Mostly occurred on 8/17. Some residual including low grade fever on 8/18 and 8/19. Seems to be recovering.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Soreness at area of injection, 102.2F fever, aches all over, weakness, tired, not hungry. Mostly occurred on 8/17. Some residual including low grade fever on 8/18 and 8/19. Seems to be recovering.
Age: 2.0
Sex: F
Vaccine: DTAP
Symptoms: Rash, Rash papular, Rash pruritic
Clinical narrative: Pruritic, erythematous, papular rash on chest and abdomen started about 24 hours after the vaccine was given. Spread to arms and legs over the next week.  Persists 12 days later. She is afebrile and the rest of her exam is normal.
Age: 17.0
Sex: F
Vaccine: HEP, HPV9, IPV, MMR, TD, VARCEL
Symptoms: Dizziness, Fall, Loss of consciousness
Clinical narrative: Resident placed three vaccines on patients left arm and one on the right arm leaving two vaccines to be given. Patient became dizzy and then fell back onto Dr. arms falling out of consciousness for approximately 10-15 seconds. Patient was placed laying down on the bench and was given juice. Patient remained laying down for another 10 minutes and then received the remaining two vaccines while laying down. After receiving final vaccines patient remained laying down for an additional 10 minutes. Patient was assessed by Dr. and was found to be alert and oriented without any dizziness.
Age: 16.0
Sex: F
Vaccine: MNQ, MENB, MNQ
Symptoms: Asthenia, Extra dose administered, Fatigue, Malaise
Clinical narrative: Mom called Saturday stating that pt didn't feel well since getting the vaccines on Friday. It was found then that pt received her second Bexsero and duplicate Menveo. It was explained to mom that she can expect typical vaccine side effects over the weekend and to come in Monday if still not feeling well. Offered to come in Saturday but declined. Mom called after hours phone bc she was worried about the duplicate vaccine. Spoke to an NP friend who told her that Menveo and Bexsero should never be given given together and can be dangerous if done so. Also explained that patient felt so bad this morning she crawled into bed with her mom. Very fatigued and weak. Also concerned if this could cause meningitis. Consulted with Dr. who said: Bexsero and Menveo are safe to give together and indicated to do so. Also in other countries Menveo is given to infants and in a specific country in some instances. She is having an exaggerated immune response because it has seen the vaccine before and will actually give her a stronger immunity to meningitis. Treat symptomatically with rest, lots and lots of fluids and Motrin.
Age: 16.0
Sex: F
Vaccine: MNQ, MENB, MNQ
Symptoms: Electrocardiogram, Gait inability, Hypersomnia, Laboratory test, Pain
Clinical narrative: Mom called Saturday stating that pt didn't feel well since getting the vaccines on Friday. It was found then that pt received her second Bexsero and duplicate Menveo. It was explained to mom that she can expect typical vaccine side effects over the weekend and to come in Monday if still not feeling well. Offered to come in Saturday but declined. Mom called after hours phone bc she was worried about the duplicate vaccine. Spoke to an NP friend who told her that Menveo and Bexsero should never be given given together and can be dangerous if done so. Also explained that patient felt so bad this morning she crawled into bed with her mom. Very fatigued and weak. Also concerned if this could cause meningitis. Consulted with Dr. who said: Bexsero and Menveo are safe to give together and indicated to do so. Also in other countries Menveo is given to infants and in a specific country in some instances. She is having an exaggerated immune response because it has seen the vaccine before and will actually give her a stronger immunity to meningitis. Treat symptomatically with rest, lots and lots of fluids and Motrin.
Age: 16.0
Sex: F
Vaccine: MNQ, MENB, MNQ
Symptoms: Palpitations, Tremor
Clinical narrative: Mom called Saturday stating that pt didn't feel well since getting the vaccines on Friday. It was found then that pt received her second Bexsero and duplicate Menveo. It was explained to mom that she can expect typical vaccine side effects over the weekend and to come in Monday if still not feeling well. Offered to come in Saturday but declined. Mom called after hours phone bc she was worried about the duplicate vaccine. Spoke to an NP friend who told her that Menveo and Bexsero should never be given given together and can be dangerous if done so. Also explained that patient felt so bad this morning she crawled into bed with her mom. Very fatigued and weak. Also concerned if this could cause meningitis. Consulted with Dr. who said: Bexsero and Menveo are safe to give together and indicated to do so. Also in other countries Menveo is given to infants and in a specific country in some instances. She is having an exaggerated immune response because it has seen the vaccine before and will actually give her a stronger immunity to meningitis. Treat symptomatically with rest, lots and lots of fluids and Motrin.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Migraine, Vision blurred
Clinical narrative: Pt stated she has been having one migraine headache per day since receiving the shot as of 8/19/19.  Stated she had one migraine on 8/17, 8/18, and 8/19.  She stated the migraines cause her head to hurt and her vision to blur.  Pt is not sure if it is the shot or not, but has had a total of 3 migraines since receiving the vaccine.  Pt stated she has advised Dr., but no treatment has been given as of yet.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site erythema, Injection site swelling, Pain
Clinical narrative: Arm at site of injection was red with some swelling. Redness was about 3 to 4 inches in circumference. This was her second injection and she did not have the reaction with the first one. She was achy starting the day after her injection and complained of flu-like symptoms, but no fever.
Age: 5.0
Sex: M
Vaccine: MMR
Symptoms: Headache, Palpitations, Pyrexia
Clinical narrative: headache all day fever heart palpitations
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles outbreak began two days after Shingrix administration
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Patient is stating that she was fine but 3 days post administration, she started getting injection site rash, redness and mild swelling. The rash is getting worse (spreading) and feels hot to touch 5 days post administration. Today is 6th day and pt came in complaining today.
Age: 56.0
Sex: M
Vaccine: MMR
Symptoms: Dyspnoea, Feeling hot, Paraesthesia
Clinical narrative: Patient experienced shortness of breath, tingling and hot all over the body.
Age: 0.42
Sex: F
Vaccine: DTAPIPV, HIBV, PNC13, RV5
Symptoms: Wrong product administered
Clinical narrative: Inadvertently administered Kinrix instead of Pediarix.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Discomfort, Erythema, Injection site reaction, Local reaction, Pain
Clinical narrative: Localized site reaction.  Redness, "heaviness", extreme soreness
Age: 83.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Injection site reaction left deltoid, including redness, warmth, swelling and tenderness of upper left arm.  Reaction peaked at about 24-30 hours post vaccination.  It improved over the next days such that by the 4th day post vaccination, all that remained of the injection site reaction was 4 mm redness and induration at the left deltoid and a small amount of residual swelling of the upper left arm.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Cellulitis
Clinical narrative: child has received each vaccine prior, but not in the current formulation (Kinrix and Proquad); cellulitis developed to right arm-seen at urgent care and put on cephalexin and oral steroids; location of cellulitis likely related to the proquad injection site
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Patient received the Shingrix vaccine and complained of arm pain 30 minutes after. Patient was instructed to take ibuprofen to alleviate pain. Patient ended up having to go to ED for extreme arm pain and loss of some mobility. Patient was started on Norco and deltasone to help with pain. May potentially follow up with an orthopedic specialist.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Musculoskeletal pain, Pain in extremity
Clinical narrative: Patient received the Shingrix vaccine and complained of arm pain 30 minutes after. Patient was instructed to take ibuprofen to alleviate pain. Patient ended up having to go to ED for extreme arm pain and loss of some mobility. Patient was started on Norco and deltasone to help with pain. May potentially follow up with an orthopedic specialist.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: swelling at site of injection, itchy, and erythyma
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site inflammation, Injection site pain
Clinical narrative: Shot given on left deltoid. Redness, inflammation, soreness appeared about 2 inches below shot location 2 days later. Counseled patient to continue to monitor site and to apply hydrocortisone cream and/or benadryl cream to reduce inflammation.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Pain
Clinical narrative: headache, chills, aches