chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No other AE reported; Expired vaccine used; This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Information regarding the patient's medical history, concomitant medications, drug allergies, or reactions was not provided.     On 15-OCT-2020, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) 0.5 milliliter, intramuscular for prophylaxis(lot # S026366, has been verified to be a valid lot number for pneumococcal vaccine, polyvalent (23-valent), expiration date reported as 17-SET-2020) (expired product administered). No other adverse event was reported.  This is one of three same reporter cases. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S026366; expirationdate: 17-SEP-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2010USA006882:
Sex: M
Vaccine: PPV, PPV
Symptoms: Inappropriate schedule of product administration
Clinical narrative: the patient also received a PNEUMOVAX23 (3.5 years ago).; This spontaneous report was received from a pharmacist referring to a 48-year-old male patient. Information about medical history, concurrent conditions and concomitant therapies was not provided.  In April 2017 (reported as 3.5 years ago), the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (strength, dose, route, lot # and expiration date were not reported) for prophylaxis. On 16-OCT-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (l dose, lot # T027110, expiration date 23-MAR-2022) (inappropriate schedule of product administration). combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T027110; expirationdate: 23-MAR-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Age: 78.0
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: the injection site got "very red, hot and painful"; the injection site got "very red, hot and painful"; the injection site got "very red, hot and painful"; the area is still "very pink and painful to the touch"; the red area became itchy; the red area "moved South towards elbow"; This spontaneous report as received from a 78-year-old patient who reported on herself. The patient's pertinent medical history and concomitant drugs medication were reported as none. Her drug allergies included aspirin (reported as "could not take anything with aspirin". On an unknown date in 2007, the patient was vaccinated with the first dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) and no adverse events occurred. It was also reported that an unknown date in June 2020 (reported as over the summer 2020); she had a "strange reaction to a new brand of biotin"; she was experiencing hives for approximately 30 minutes every morning after taking the medication.  On 12-OCT-2020, the patient was vaccinated with the second dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (exact dose, route of administration, lot # and expiration date were not reported) in the right arm for prophylaxis. On the same date, she was vaccinated with an unspecified "senior flu shot" in the opposite arm. On 12-OCT-2020, the patient stated that the injection site got "very red, hot and painful." After approximately 2 to 3 days after the injection in October 2020, the red area "moved south towards the elbow". The red area became itchy and she was taking acetaminophen (TYLENOL) and an unspecified antihistamine to help with itchiness. It was reported that the itching subsided but the area was still "very pink and painful to the touch." The patient sought medical attention- she reached out to the pharmacist who informed her that "some people had a strong reaction" and she wanted to know if her reaction was a common one. None of the laboratory diagnostics or studies were performed. The outcome of the events was reported as recovering.  The relatedness between the aforementioned events and the suspect vaccine was not provided.  This is one of two reports from the same reporter.; Sender's Comments:  US-009507513-2010USA007848:
Sex: M
Vaccine: HPV9
Symptoms: Incomplete course of vaccination, No adverse event
Clinical narrative: No additional AE or PQC.; the patient and received his first dose of the GARDASIL 9 3-dose series about 11 months ago but has not received the remaining doses in the series; This spontaneous report was received from a male pharmacist of unknown age referring to himself. The patient's pertinent concurrent conditions, medical history, concomitant medications and previous drug reactions or allergies were not provided.   On an unspecified date in November 2019 (reported as 11 months ago), the patient was vaccinated with first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9)  0.5 milliliter as prophylaxis (concentration. anatomical location and route of administration, lot number and expiration date were not reported). The patient was not received the second and third dose at the time of this report, therefore he was wondering what was the timeline for series completion (inappropriate schedule of product administration). No adverse events were reported.
Age: 66.0
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No additional AE reported; VARIVAX was administered to a patient today in error. He was supposed to get a dose of SHINGRIX; This spontaneous report was received from a nurse, referring to a 66-year-old male patient. The patient's pertinent medical history, concurrent conditions, concomitant medications, previous drug reactions, or allergies were not reported.  On 19-OCT-2020, the patient was administered varicella virus vaccine live (oka/merck) (VARIVAX) injection (strength, vaccination scheme, anatomical site of injection and route of administration were not reported; lot number T000697, expiration date: 07-JAN-2022) in error, as prophylaxis. The patient was supposed to get a dose of zoster rgE vaccine (mammalian) (SHINGRIX) (wrong product administered). No additional adverse effects reported.
Sex: F
Vaccine: PPV
Symptoms: Ill-defined disorder, Mobility decreased, Skin reaction
Clinical narrative: she had all her left arm (from shoulder to fingers) difficulty to move after a week.; localized reaction; she had another issue but did not mention what it was; This spontaneous report was received from an unknown female patient concerning herself. There was no information about the patient's medical history, concurrent conditions or concomitant medication. On an unknown dates, the patient was vaccinated with vaccinated with a first and second dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) for prophylaxis (route of administration, lot number and expiration date were not reported).  It was reported after the first dose of vaccination the patient experienced a localized reaction, on an unspecified date. The patient stated that after received the second dose she had all her left arm (from shoulder to fingers) difficulty to move after a week (mobility decreased). She said that she had another issue but did not mention what it was (Ill-defined disorder). She wanted to know if she would have another reaction if she gets another shot like exempt in limp swelling. The outcome of local reaction, ill-defined disorder  and mobility decreased  was unknown. The causal relationship between the aforementioned events and pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23)  was unknown.
Sex: F
Vaccine: FLUX
Symptoms: Arthralgia, Chills, Headache, Nausea, Pyrexia
Clinical narrative: joint pain; fever of 100.3 Fahrenheit; chills; nausea; headache; This case was reported by a consumer via other manufacturer and described the occurrence of joint pain in a female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2020-2021 season) for prophylaxis.   Co-suspect products included thyroid for product used for unknown indication and lenvatinib mesilate (Lenvima) for product used for unknown indication.   Concurrent medical conditions included endometrial carcinoma. Concomitant products included pembrolizumab (Keytruda).   On 7th October 2020, the patient received Influenza vaccine Quadrivalent 2020-2021 season. On an unknown date, the patient started thyroid at an unknown dose and frequency and Lenvima 20 mg at an unknown frequency. On 8th October 2020, 1 days after receiving Influenza vaccine Quadrivalent 2020-2021 season, the patient experienced joint pain, fever, chills, nausea and headache. The action taken with thyroid was unknown. The action taken with Lenvima was unknown. On an unknown date, the outcome of the joint pain, fever, chills, nausea and headache were unknown.   The reporter considered the joint pain, fever, chills, nausea and headache to be related to Influenza vaccine Quadrivalent 2020-2021 season.  Additional details were provided as follows: The patient has endometrial carcinoma C54.1.  The patient was taking with Keytruda. The age at vaccination was not reported. The patient reported having chills, fever of 100.3 degree Fahrenheit and nausea on the first day of taking Lenvima (8th October 2020). Patient thinks that it was related to her Thyroid dosage decreased on Tuesday 6th October 2020and getting the flu shot on Wednesday 7th October 2020, does not think that it was related to Lenvima. The patient reported headache and joint pain that she has had since she starting Lenvima.
Sex: F
Vaccine: VARZOS
Symptoms: Bedridden, Chills, Headache, Pyrexia
Clinical narrative: Grade 3 side effects from Shingrix that put her in bed for a couple days.; Headache; chills; fever; This case was reported by a other health professional via sales rep and described the occurrence of bedridden in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th June 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced bedridden (serious criteria other: grade 3 side effects), headache, chills and fever. On an unknown date, the outcome of the bedridden, headache, chills and fever were recovered/resolved.   It was unknown if the reporter considered the bedridden, headache, chills and fever to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. After receiving Shingrix, the patient experienced grade 3 side effects that put her in bed for a couple days. The patient also experienced headache, chills and fever. For the tolerance of 2nd dose, refer linked case US2020AMR209262.; Sender's Comments:  US2020AMR209262:2nd dose
Sex: U
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: 100.00 fever; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain (received 1st dose on an unknown date, refer case US2020AMR210049).   On 16th October 2020, the patient received the 2nd dose of Shingrix. On 19th October 2020, 3 days after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was unknown.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not provided. The patient received 2nd Shingrix vaccination on Thursday and developed 100.00 fever on Monday. No side effects other than local soreness with first vaccination and until time of reporting with second.  The reporter asked if developing a fever three days post vaccination was an expected side effect.?; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR210049:Same patient, 2nd dose
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Genital rash, Herpes zoster, Insomnia, Rash
Clinical narrative: believes it is shingles caused by the Shingrix injection /  suspected vaccination failure; shingles; chills / shivering; rash to left genital area; rash to neck, and arms; Difficulty sleeping; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included rash (to right thigh on and off for 30 years).   On an unknown date, the patient received the 1st dose of Shingrix. On 25th June 2020, the patient received the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix and less than 4 months after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, chills, genital rash, rash and difficulty sleeping. The patient was treated with acyclovir. On an unknown date, the outcome of the vaccination failure and shingles were unknown and the outcome of the chills, genital rash, rash and difficulty sleeping were recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles, chills, genital rash, rash and difficulty sleeping to be related to Shingrix and Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient reported case for herself. The patient had a rash on and off to her right thigh for thirty years but never had a rash in the left genital area. The patient could not remember when she had her first Shingrix injection but she had no adverse reaction from it. However, she stated after she had the second injection she had a rash to her left genital area, neck, and arms. She stated that she also had chills, and shivering, and difficulty sleeping. The patient seen her physician who ordered acyclovir for this rash but wanted to report that she believes it was shingles caused by the Shingrix injection. This case was considered as suspected vaccination failure as details regarding laboratory test confirmation and time to onset for the event was unknown at the time of reporting The reporter consented to follow up.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Vaccination failure
Clinical narrative: believes it is shingles caused by the Shingrix injection /  suspected vaccination failure; shingles; chills / shivering; rash to left genital area; rash to neck, and arms; Difficulty sleeping; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included rash (to right thigh on and off for 30 years).   On an unknown date, the patient received the 1st dose of Shingrix. On 25th June 2020, the patient received the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix and less than 4 months after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, chills, genital rash, rash and difficulty sleeping. The patient was treated with acyclovir. On an unknown date, the outcome of the vaccination failure and shingles were unknown and the outcome of the chills, genital rash, rash and difficulty sleeping were recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles, chills, genital rash, rash and difficulty sleeping to be related to Shingrix and Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient reported case for herself. The patient had a rash on and off to her right thigh for thirty years but never had a rash in the left genital area. The patient could not remember when she had her first Shingrix injection but she had no adverse reaction from it. However, she stated after she had the second injection she had a rash to her left genital area, neck, and arms. She stated that she also had chills, and shivering, and difficulty sleeping. The patient seen her physician who ordered acyclovir for this rash but wanted to report that she believes it was shingles caused by the Shingrix injection. This case was considered as suspected vaccination failure as details regarding laboratory test confirmation and time to onset for the event was unknown at the time of reporting The reporter consented to follow up.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Feeling cold, Inappropriate schedule of product administration, Influenza like illness, Pyrexia
Clinical narrative: flu-like symptoms; fever; chills; First dose was received last year / second dose was received recently; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced influenza-like symptoms, fever, chills and drug dose administration interval too long. On an unknown date, the outcome of the influenza-like symptoms, fever, chills and drug dose administration interval too long were unknown.   It was unknown if the reporter considered the influenza-like symptoms, fever and chills to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The patient received 1st dose last year and the second dose was received recently at the time of reporting, which led to lengthening of vaccination schedule. The patient received the first dose she had flu-like symptoms with chills and fever. The patient did not consent to follow up.
Sex: F
Vaccine: FLU4
Symptoms: Exposure during pregnancy, Syringe issue, Underdose
Clinical narrative: A pregnant patient was administered with fluzone quadrivalent/no AE; It was unable to determine that how much vaccine that the patient had received/no AE; some of the product leaked out where the needle was connecting to the syringe/no AE; Initial information was received on 12-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer and other health care professional.  This case involves a female patient who was administered with INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] 0.5 ml prefilled syringe while she was pregnant (exposure during pregnancy) and during administration some of the product leaked out where the needle was connecting to the syringe (device leakage) and it was unable to determine that how much vaccine that the patient had received (under dose). It was also reported that they asked whether or not a second dose was safe in pregnancy  Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known.   Gestation period was not reported.  The date of last menstrual period was not reported.  The estimated due date was not reported.  The patient's medical history, concomitant therapy, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received 0.5 mL dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (injection, suspension) (lot UT7058JA and expiry date 30-JUN-2021) via unknown route in unknown administration site for prophylactic vaccination.  It was a case of vaccine under dose (latency was on same day) and device leakage.  It was also the case vaccine exposure during pregnancy. The patient was pregnant when she received vaccine.  Relevant prenatal testing after exposure was not reported.  At the time of reporting, no adverse event was reported.  Additionally, at time of reporting, the outcome of the pregnancy was not reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Global PTC: 100073772 Investigation status: In process Issue status: In process Batch number: UT7058JA Sample Status: Not available
Sex: U
Vaccine: FLUX
Symptoms: Mobility decreased, Nerve injury, Neuralgia
Clinical narrative: It attacked thoracic nerve and pain; couldn't use right arm for 2 years; Initial information received on 18-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer via social media.  This case involves patient (unknown demographics) who experienced attacked thoracic nerve and pain (neuralgia) and couldn't use right arm for 2 years (mobility decreased), while he/she received vaccine INFLUENZA VACCINE.  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date: not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious it attacked thoracic nerve and pain (neuralgia) and couldn't use right arm for 2 years (mobility decreased) (unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data not reported.    It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome of event was not reported.  There will be no information available on the batch number for this case.
Age: 2.0
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Medication error, No adverse event, Product reconstitution quality issue
Clinical narrative: a dose of PENTACEL was administered prior to reconstituting with ActHib portion of vaccine/ no AE; Initial information was received on 05-Oct-2020 regarding an unsolicited valid non-serious case from a nurse.  This case involves a 2-year-old female patient who received a dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] prior to reconstituting with ACT-HIB portion of vaccine (product preparation error).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included INFLUENZA VACCINE (INFLUENZA VACCINE) for Immunisation; MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR VACCIN) for Immunisation; and VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for Immunisation.  On 02-Oct-2020, the patient received a dose of 0.5 ml suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot UJ343ABA, expiry date-22-Jun-2021) via intramuscular route in the thigh for prophylactic vaccination prior to reconstituting with ACT-HIB portion of vaccine (product preparation error).  This was a case of actual medication error due to active ingredient not added to diluent (latency same day).  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: 18 year old male patient was administered an expired dose of Menactra, no AE; Initial information received on 06-Oct-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 18 year old male patient who was vaccinated with an expired dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (expired product administered).  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included MENINGOCOCCAL VACCINE B (MENINGOCOCCAL VACCINE B) for Immunisation.  On 05-Oct-2020, the patient received a 0.5 ml dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot U6365AA and expiry date: 24-Sep-2020) via an intramuscular route in the right arm for prophylactic vaccination.  It was a case of actual medication error due to expired vaccine used (latency on same day).  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Burning sensation, Injection site pain, Nausea, Vomiting
Clinical narrative: Patient describes pain and burning at injection site, as well as nausea and vomitting.
Age: 4.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Eye swelling, Urticaria
Clinical narrative: Urticarial Rash, Swelling of eyes in 30 minutes
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Malaise, Syncope
Clinical narrative: Patient came to get a flu vaccine. Upon consultation prior to vaccine she gets the vaccine every year with no adverse reaction. After giving the patient the flu vaccine about 5 minutes later the patient stated she was not feeling well so the pharmacist asked her to have a seat and gave her some water about 2 minutes later patient fainted in her chair. We called 911 immediately within a couple of minutes the paramedics came and took the patient to the hospital
Age: 8.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site rash, Local reaction
Clinical narrative: Patient developed a local reaction after administration of vaccine.  Area is reddened with small bumps in the area the vaccine was given left upper arm.
Age: 76.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Peripheral swelling, Rash macular, Skin warm
Clinical narrative: Patient came in and showed me her red swollen arm. She said it was hot to touch and she was very concerned. It was red splotchy and looked obviously swollen. It did appear to be in her deltoid muscle.
Age: 46.0
Sex: M
Vaccine: FLU4
Symptoms: Angioedema
Clinical narrative: Reported angioedema 12 days s/p vaccination.  Symptoms have resolved at this time.
Sex: U
Vaccine: MMR, MMRV
Symptoms: Incorrect dose administered, Wrong product administered
Clinical narrative: patient received PROQUAD in July and then MMR II third dose accidently today; This spontaneous report as received from a physician referring to a 5-year-old patient. The patient's pertinent medical history, drug reactions/allergies, concurrent condition and concomitant medication were not provided.  On unknown dates, the patient was vaccinated with two doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) 0.5 ml (strength, route, lot# and expiration date were not reported) for prophylaxis.   The reporter stated that the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (dose, frequency, route, lot# and expiration date were not reported) on an unknown date in July 2020 for prophylaxis. Then, on 08-OCT-2020, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) dose 3, 0.5 milliliter (Incorrect dose administered). The outcome of the event was not reported.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer and a patient of unknown age and gender regarding a case in litigation. Information about concurrent condition, medical history and concomitant medication was not reported. On or about 17-NOV-2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot# and route unknown) for the long-term prevention of shingles and zoster-related conditions. Subsequent to the inoculation (date not reported), the patient was treated by a physician for shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the event shingles was not recovered. The causality assessment was considered as related by the lawyer.
Sex: U
Vaccine: VARZOS
Symptoms: Deafness
Clinical narrative: hearing loss; Information has been received from a lawyer and a patient of unknown age and gender regarding a case in litigation. Information about concurrent condition, medical history and concomitant medication was not reported. In 2013, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot# and route unknown) for the long-term prevention of shingles and zoster-related conditions. Subsequent to the inoculation (date not reported), the patient was treated by a health care provider for hearing loss. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the event hearing loss was not recovered. The causality assessment was considered as related by the lawyer.  Upon internal review, hearing loss was determined to be medically significant.
Sex: U
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: sick; Initial information was received on 18-Oct-2020 regarding an unsolicited valid non-serious social media case from the patient.  This case involves an unknown demographic patient who was sick (malaise), while the patient received vaccine INFLUENZA VACCINE.  The patient had flu 4 times in the last 15 years (however not specified if had after vaccination).  The patient's past medical treatment(s), vaccination(s), family history and concomitant medication were not reported.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer, batch number and other dosing details were not reported) for prophylactic vaccination.  On an unknown date, the patient was sick (malaise), (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported that, the patient had absolute sickest year after taking vaccine and shot was only 40-60 % effective most years.  Details of laboratory data were not reported.  The patient ate food and took vitamins that supported her immune system as corrective treatment.  The patient had recovered from the event on an unknown date.  There will be no information available on the batch number for this case.    This case is linked to cases 2020SA294135, 2020SA294140, 2020SA294160, 2020SA294161, 2020SA294162, 2020SA294163, 2020SA294142, 2020SA294143, 2020SA294164, 2020SA294165, 2020SA294144, 2020SA294145, 2020SA294166, 2020SA294167, 2020SA294174, 2020SA294175, 2020SA294146, 2020SA294147, 2020SA294148, 2020SA294168, 2020SA294169, 2020SA294149, 2020SA294170, 2020SA294171, 2020SA294151, 2020SA294172, 2020SA294173, 2020SA294150, 2020SA294152, 2020SA294153, 2020SA294154, 2020SA294155, 2020SA294156, 2020SA294136, 2020SA294137, 2020SA294157, 2020SA294158, 2020SA294138, 2020SA294139, 2020SA294159 and 2020SA294231 (same reporter).
Age: 14.0
Sex: M
Vaccine: FLU4, HPV9, MNQ, TDAP
Symptoms: Asthenia
Clinical narrative: Pt received 4 vaccines at 9:13 AM on 10/23/2020 (see above). Pt states that he feels weak, had to lay down @ 9:21 AM.  Pt responding to questions appropriately, just says that he feels weak. Allowed him to lay down for as long at he needed. Pt states that he was feeling better around 9:35, BP checked 120/68, pulse ox 96%, pulse 80. States he had some apple juice this morning. Pt states he feels completely better and was allowed to leave with father.
Age: 73.0
Sex: M
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: Continued pain in left arm after shot now for nearly a week.
Age: 1.5
Sex: M
Vaccine: FLUX, HEPA
Symptoms: Rash, Rash erythematous
Clinical narrative: Red, spotty rash starting out light and small day of vaccines and growing increasingly darker and larger over the week. Rash started on torso and spread throughout body to legs, arms, feet and some on the face. Required Benadyl prescription
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Lymphadenopathy, Pain, Pain in extremity, Skin discolouration
Clinical narrative: Sore arm, red to elbow and under arm near breast on left side, purple and very painful. Pt went to hospital, had x-rays, lymphadenophy. Hospital. Sent to pcp.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: X-ray abnormal
Clinical narrative: Sore arm, red to elbow and under arm near breast on left side, purple and very painful. Pt went to hospital, had x-rays, lymphadenophy. Hospital. Sent to pcp.
Age: 6.0
Sex: F
Vaccine: PPV
Symptoms: Crying, Injection site rash, Limb discomfort, Pain in extremity, Rash erythematous
Clinical narrative: Day after vaccine patient kept complaining that arm was hurting and was crying, would not use arm to eat etc. I looked at arm around 3 pm and there was red splotchy raised rash from upper arm to about the elbow of arm and patient could not bend arm. I took photo and sent photo to patients pediatrician. She advised to give Benadryl and Neurontin over night. Rash has came down over night, and now is only in a small area right around injection sight, arm is still sore.
Age: 6.0
Sex: F
Vaccine: PPV
Symptoms: Rash papular
Clinical narrative: Day after vaccine patient kept complaining that arm was hurting and was crying, would not use arm to eat etc. I looked at arm around 3 pm and there was red splotchy raised rash from upper arm to about the elbow of arm and patient could not bend arm. I took photo and sent photo to patients pediatrician. She advised to give Benadryl and Neurontin over night. Rash has came down over night, and now is only in a small area right around injection sight, arm is still sore.
Age: 47.0
Sex: F
Vaccine: FLUC4
Symptoms: Paraesthesia
Clinical narrative: patient experienced tingling down her arm immediately after receiving the shot. That feeling continued for 2 weeks. She said she can feel the tingling whenever she is using her fingers (on her phone & while typing)
Age: 12.0
Sex: F
Vaccine: MENB
Symptoms: Unevaluable event
Clinical narrative: We were not aware that this had happened. The health department called me today and they noticed that this happened. I found the patient and filled out this report for the employee that performed the immunization since that employee is out of the office today. We never had a call that the patient had an adverse reaction of any kind.
Age: 70.0
Sex: F
Vaccine: FLUA4
Symptoms: Chills, Decreased appetite, Dizziness, Nausea, Pyrexia
Clinical narrative: Received flu vaccine at 8:40 am on 10/13/20. That evening, around 6 pm, felt subjectively feverish, dizzy/lightheaded, experienced chills, and was nauseous with no appetite.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Skin warm
Clinical narrative: PATIENT SAID HER ARM IS RED DOWN TO HER ELBOW AND THE SKIN IS WARM TO THE TOUCH.
Sex: F
Vaccine: HEP, VARCEL
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain, Injection site pruritus, Injection site rash
Clinical narrative: Painful, itchy rash, cellulitis, redness, swelling of arm at injection site.  Antibiotic (Keflex) given Medrol dose pack Symptoms resolved
Sex: F
Vaccine: HEP, VARCEL
Symptoms: Injection site swelling
Clinical narrative: Painful, itchy rash, cellulitis, redness, swelling of arm at injection site.  Antibiotic (Keflex) given Medrol dose pack Symptoms resolved
Age: 73.0
Sex: F
Vaccine: FLU4, FLU4, VARZOS, VARZOS
Symptoms: Burning sensation, Fatigue, Headache, Influenza like illness
Clinical narrative: Burning sensation in arm. Took pain meds to stop the pain with headache. Next morning, felt like the Flu. Bad headache, extremely tired. The burning was all the way into her arm. Will not have the second dose.
Age: 66.0
Sex: F
Vaccine: FLUC4
Symptoms: Hypoaesthesia, Oropharyngeal discomfort, Productive cough
Clinical narrative: About 2 hours after she had the vaccine, she felt a thickness in her throat, phlegm inducing, and numbness. She took Benedryl, went to bed and symptoms resolved.
Age: 64.0
Sex: M
Vaccine: FLU4
Symptoms: Back pain, Pain in extremity
Clinical narrative: Patient came in stating his arm hurts after the flu shot.  He stated it did not hurt initially but started possibly 3-4 days after the shot.  He states there is some additional pain in his back, but is not sure if that started before or after the vaccination.  He states that he normally takes Aleve for pain, but it does not seem to be helping much.
Age: 10.0
Sex: M
Vaccine: FLUC4
Symptoms: Urticaria
Clinical narrative: Recurring hives
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Blood pressure decreased, Pyrexia, Tremor, Vision blurred
Clinical narrative: Patient is experiencing blurry vision, shaking blood pressure drop to 75-85/65-75, fever all seven days past  he injection
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: Pain that has not resolved in the arm after administration.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Loss of consciousness, Malaise
Clinical narrative: About 20 minutes after I gave the Menactra vaccine was applying LMX cream to patients arm for a blood draw and she stated she didn't feel well. I told her to take some nice slow deep breathes, she then slumped slightly on the couch. Within a few seconds she opened her eyes stating she was ok. I asked if she was alright and feeling better she said yes, I put her feet up and got her apple juice and graham crackers. I also took her blood pressure and pulse which were within normal range. The patient at the crackers and drank the juice, one of our doctors assessed the patient, spoke with the patient and her mother. I rechecked on her after 15 minutes, she stated she felt better and was ready to leave. The patient and her mother left with no further incident.
Age: 25.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Joint range of motion decreased, Pain
Clinical narrative: 25-year-old female RN was received a flu shot on 09/28/2020. She denies any abnormal placement or sensation during the administration. She tells me that last Wed (10/21/2020) she developed redness and swelling around the injection site on the left arm. She reports that this started with a reduced AROM. She tells me that she had not felt that type of reaction previously. She reports the pain worsened and has since been stable. She denies any fevers but reports a 99+ temp as the highest in the last week.  She denies numbness or tingling. She has been using Tylenol for pain as she is allergic to NSAIDs. On presentation she reports that she had constant pain rated 4/10 while sitting which is described as a dull ache. The pain is worsened with over the head reaching and forward reaching as well as direct pressure. She denies other medical problem and possibility of being pregnant. She Denies any recent illness.
Age: 7.0
Sex: M
Vaccine: FLU4
Symptoms: Rash
Clinical narrative: Rash all over left arm
Age: 19.0
Sex: F
Vaccine: FLU4
Symptoms: Pain, Pruritus, Swelling
Clinical narrative: itchness, soreness, swelling
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: L upper arm swelling (deltoid region) hours after injection. Patient reports it became worse day after immunization. She reports it swelled bigger, became red & itchy. Today, injection site is warm, red, tender. Localized swelling comparable to golf ball sized.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Localised oedema
Clinical narrative: L upper arm swelling (deltoid region) hours after injection. Patient reports it became worse day after immunization. She reports it swelled bigger, became red & itchy. Today, injection site is warm, red, tender. Localized swelling comparable to golf ball sized.
Age: 9.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site warmth
Clinical narrative: Patient developed a 3x2 1/2 inch erythematous, warm, papular rash on left thigh around the site of injection with no induration. Rash is also itchy per patient.
Age: 41.0
Sex: F
Vaccine: PPV
Symptoms: Dizziness, Injection site pain, Pyrexia
Clinical narrative: Significant arm pain at injection site, dizziness and fever
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Swelling
Clinical narrative: She had received the Tdap vaccine one day prior. Her pain is located in her right arm (site of injection), extending to right shoulder and right upper back. It does not extend into her neck. It does not extend across her chest. No warmth or redness at injection site. Some swelling of right trapezius muscle. She has used Ibuprofen, Bayer Back and Body, and Excedrin without relief. It is aching in nature, 6-7/10 in intensity. She has no fever, chills, chest pain or shortness of breath, no nausea, vomiting or diarrhea.
Age: 12.0
Sex: F
Vaccine: FLU4, HPV9, MNQ, TDAP
Symptoms: Urticaria
Clinical narrative: hives
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Red, warm, raised area on thigh started 10/20/2020. Evaluated in clinic by Dr. 10/23/2020. No treatment necessary.
Age: 80.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site infection, Injection site pain, Injection site warmth
Clinical narrative: ONE DAY AFTER PATIENT RECEIVED THE VACCINATION SHE REPORTED SORENESS AND REDNESS AT THE INJECTION SITE. SHE ALSO STATED IT WAS HOT TO THE TOUCH.  SHE WENT TO HER MD, WHO STATED IT WAS AN INFECTION FROM THE VACCINE AND THAT THE PHARMACY NEEEDED TO REPORT IT TO VAERS.
Age: 66.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema
Clinical narrative: dollar size red area around injection site    having patient put ice on it.  patient spoke to md and md said to apply ice packs and if not better by monday then call md again monday
Age: 71.0
Sex: M
Vaccine: PPV
Symptoms: Rash
Clinical narrative: Rash beginning under both arms and spreading over most of body.  Taking Diphengydramine HCI, still awaiting outcome.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: herpes zoster; Information has been received from a lawyer and a patient of unknown age regarding a case in litigation. Information about concurrent condition, medical history and concomitant medication was not reported. On or about 09-DEC-2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot# and route unknown) for the long-term prevention of shingles and zoster-related conditions. Subsequently, the patient was treated by a provider for the following injury resulting from zoster vaccine live (ZOSTAVAX): herpes zoster. The outcome of the event was unknown. The causality assessment was considered to be related by the lawyer.
Age: 1.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: PROQUAD was administered to a 1 year old patient along with VARIVAX insted of MMR.; PROQUAD was administered to a 1 year old patient along with VARIVAX insted of MMR.; This spontaneous report was received from a registered nurse and refers to a 1-year-old patient of an unknown gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.    On 20-OCT-2020, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) 0.5 milliliter, once, lot # T018279 was confirmed to be valid, expiration date 23-NOV-2021 (route and site of administration were not provided), which was reconstituted with sterile diluent (STERILE DILUENT) lot # T001190 was confirmed to be valid, expiration date was not provided but upon internal validation was established as 29-AUG-2022, and varicella virus vaccine live (oka/merck)(VARIVAX) (dose, lot#, expiration date, route and site of administration were not provided), both for prophylaxis. Other suspect vaccines included measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (lot# and expiration date were not provided).   On that day, the patient experienced overdose and wrong product administered. The patient received measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) with varicella virus vaccine live (oka/merck)(VARIVAX) but was supposed to received varicella virus vaccine live (oka/merck)(VARIVAX) with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II). The outcome of overdose and wrong product administered were unknown.