chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No other adeverse effects were reported.; patient received a dose of MMR II following a temperature excursion; This spontaneous report was received from an administrator and refers to a patient of an unknown age and gender. No information regarding the patient's concurrent condition, medical history and concomitant medications was provided. On 02-DEC-2019, the patient was vaccinated with a dose of improperly stored (following a temperature excursion) measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), albumin status rHa, lot # R014690, expiration date 23-MAY-2020 (dose and route of administration were not provided) for prophylaxis. No adverse effects were reported. On an unknown date, the temperature was 78 Fahrenheit degrees (26 Celsius degrees) or warmer ( 32 Celsius degrees) for 1 hour and 55 minutes. There was no previous temperature excursion. Data logger was involved.   The outcome of the event were unknown.
Sex: F
Vaccine: HPV9
Symptoms: Lymphadenitis
Clinical narrative: has been admitted to an unspecified hospital on an unspecified date since being administered the GARDASIL 9/the patient has cervical node inflamation/the patient will require surgery; This spontaneous report was received from a physician via company representative and refers to a female patient of an unknown age. There was no information about the patient's concurrent condition, concomitant medication and medical history provided.   On an unknown date in October 2019 (reported as about 2 months ago), the patient was vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for prophylaxis (exact dose, lot number and expiration date were not reported). On an unknown date in 2019 (also reported as within the past 2 months), the patient experienced cervical node inflammation and was admitted to an unspecified hospital. The physician stated that the patient would require surgery.  The outcome of the event was not recovered. The causality assessment was not provided.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse symptoms; patient was administered a dose of PROQUAD (lot S003863 expiration 08/08/2020) in error; This spontaneous report was received from a registered nurse regarding a patient of an unknown age and gender. The patient's concurrent condition, medical history, concomitant therapies and drug allergies were not reported. On 06-DEC-2019, the patient was administered with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) in error (lot number S003863 and expiry date 08-AUG-2020) (strength and route were not reported) for prophylaxis. The nurse intended to administer measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (strength, dose, route, lot/batch number and expiry date were not reported) for prophylaxis (wrong product administered). No adverse symptoms were reported (no adverse event). There was no product quality complaint reported. The outcome of the events were unknown.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse symptoms; Received second dose of VARIVAX series that was improperly stored; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant therapy details were not reported.     On 20-NOV-2019, the patient was vaccinated with second dose of improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (product storage error) lot # S004554 expiry date 14-FEB-2019 (strength and route were not reported) for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent. No additional symptoms were reported. The vaccine was exposed to a temperature of 6.5 Fahrenheit for a time frame of 20 minutes. Previous temperature excursion was for 8.1 Fahrenheit for 25 minutes. Data logger was involved. No further information was reported.
Sex: F
Vaccine: HPV4, HPV9
Symptoms: Inappropriate schedule of product administration
Clinical narrative: a 35-year-old woman was vaccinated with "HPV" vaccine; This spontaneous report was received from the patient's friend and refers to a 35 year old female patient. The patient's concurrent conditions included insurance issue. The patient's concomitant therapies and medical history were not reported.  In September 2019, the patient was vaccinated with her first dose of unidentified Merck hpv vaccine (name, dose, vaccination site, route and lot number were not provided), as human papillomavirus (HPV) vaccine. Then, in November 2019, the patient was vaccinated with her second dose of unidentified Merck hpv vaccine (name, dose, vaccination site, route and lot number were not provided), as human papillomavirus (HPV) vaccine.  She complained that when she sought vaccination her insurance plan was unwilling to cover it because at 35, she was older than the indicated age range for vaccination.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional adverse events; 1st dose of GARDASIL 9 in 2016, second dose of  GARDASIL 9 in 2017, and 3rd dose of GARDASIL 9 was administered on 10-DEC-2019.; This spontaneous report was received from a pharmacist referring to a approximately 22 -year-old patient of unknown gender. The patient's pertinent concurrent conditions, medical history, concomitant medications and previous drug reactions or allergies were not reported.   On an unspecified date in 2016, 2017 and 10-DIC-2019, the patient was vaccinated with the first, second and third dose respectively with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (concentration, route and anatomical location of vaccination, lot number and expiration date were not reported) as prophylaxis. (inappropriate schedule of product administration). No adverse event was reported on the patient.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: injection site pain; This case was reported by a physician via sales rep and described the occurrence of injection site pain 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, unknown after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported, however it could be over 50 years. The reporter stated that the patient had pain at injection site after vaccination. The patient refused second dose due to the adverse event. This case has been linked to US2019AMR222635, reported by the same reporter.
Sex: F
Vaccine: TDAP, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: refrigerator was off for 8 hours with the highest temp 60.1 F/no AE; Based on information previously received with CSD: 02-JUL-2018, the following information [Listedness assessed for both suspects and seriousness criteria "Intervention required" was unticked and case was downgraded to non-serious] has been amended.  Based on information previously received with CSD: 02-JUL-2018, the following information [Reporter's State was updated ] have been amended.  Initial information received on 02-Jul-2018 regarding an unsolicited valid non-serious case received from a nurse.  This case involves an adult female patient (unknown age), who was tested with 0.1 ml dose of TUBERSOL (TUBERCULIN TEST) (lot - C5471AA, 09-Aug-2020, dose in series, route of administration was not reported) in the right arm and DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (ADACEL) (batch number, expiry date, dose, dose in series, route and site of administration was not reported which was stored in the refrigerator that was off for 8 hours on an unknown date at Jun-2018.  The Patient's medical history and concomitant medications were not reported.  It was a case of actual medication error due to incorrect product storage. The test failed to show up for the reading of the test and has planned for other test in Jan-2018.  No other adverse events had been 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.  Addendum: Based on information previously received with CSD: 02-JUL-2018, the following information [Reporter's State was updated] have been amended.  Addendum: Based on information previously received with CSD: 02-JUL-2018, the following information (Listedness assessed for both suspects and seriousness criteria "Intervention required" was unticked and case was downgraded to non-serious] has been amended).
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Product storage error
Clinical narrative: patient was given a vaccine that reached a temperature excursion and should have been discarded; Based on information previously received with CSD: 13-MAR-2019, the following information have been amended.   Initial information received on 13-Mar-2019 regarding an unsolicited valid non-serious case received from a nurse by phone.  This case is linked to case 2019SA072022 (same reporter).  This case involves a 11 years old male patient who was vaccinated with a dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (batch number: U153AA and expiry date: 21-Mar-2020, dose, dose in series and route of vaccination was not reported) in the arm on 11-Mar-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  No other vaccines given.   It was a case of actual medication error due to incorrect product storage. It was reported that Menactra vaccine that had experienced a temperature excursion. The vaccine was deemed expired as a result of the excursion.   It was unknown if any adverse event occurred or not following the vaccination.  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.   Addendum: Based on information previously received: 13-MAR-2019, the following information have been amended.
Age: 72.0
Sex: F
Vaccine: FLU4
Symptoms: Productive cough, Sputum discoloured
Clinical narrative: productive cough with yellowish green phlegm; productive cough with yellowish green phlegm; Initial information received on 29-Oct-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 72 years old female patient who experienced productive cough with yellowish green phlegm (Productive cough and Phlegm discoloured), while she received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's medical history included Hypersensitivity, Epstein-Barr virus infection, unspecified Cardiac disorder and was hospitalized 6 times in the past. At the time of the event, the patient had ongoing Asthma, Arthritis, Hypothyroidism and use of cannabis. The patient's past medical treatment included Levaquin for productive cough. The patient's past vaccination(s) included INFLUENZA vaccine last year and FLU VACCINE VII (flu shot of High dose) the year before the influenza vaccination.. The patient's past family history was not provided.  On 29-Oct-2019, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number not reported via unknown route in unknown administration site.  On 29-Oct-2019, the patient developed a non-serious productive cough with yellowish green phlegm (productive cough and Phlegm discoloured), same day following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Final diagnosis was productive cough with yellowish green phlegm.  It was not reported if the patient received a corrective treatment.  The patient outcome is reported as Not Recovered / Not Resolved on an unknown date for productive cough with yellowish green phlegm.  Information on the batch number was requested.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Pain, Product administered at inappropriate site, Tenderness
Clinical narrative: vaccine was injected in the Bursa sac of her arm causing pain in her left side with tenderness, having pain near the where her arms rotate as well; consumer thinks it was given in the "bursa sac"; Initial information received on 14-Nov-2019 regarding an unsolicited valid non-serious case received from a Nurse.  This case involved a 59 years old female patient for whom vaccine was injected in the Bursa sac of her arm causing pain in her left side with tenderness, having pain near the where her arms rotate as well (pain) was reported, while she received vaccine INFLUENZA QUADRIVAL A-B VACCINE (FLUZONE QUADRIVALENT).  Medical history and concomitant medication were not reported.  On 30-Oct-2019, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (Lot number- QFAA1937) in left arm.  On an unknown date, unknown latency following vaccination with INFLUENZA QUADRIVAL A-B VACCINE, patient experienced vaccine was injected in the Bursa sac of her arm causing pain in her left side with tenderness, having pain near the where her arms rotate as well (pain).  It was a case of actual medication error due to vaccine administered at inappropriate site. According to the patient injection was given in the "bursa sac" and is complaining of pain.  (Other relevant tests included lab data was not reported.)  Corrective treatment not reported.  Outcome was unknown.  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
Sex: F
Vaccine: FLU4
Symptoms: Drug hypersensitivity, Fatigue, Feeling abnormal, Headache, Lymphadenopathy
Clinical narrative: fatigue; burning pain when her clothing touched her skin; headache; swelling in the right arm and arm pit; swollen glands in the back of her neck as well.; didn't feel were normal; nerve pain in her right elbow; pain in the right side of her neck.; took "sulfa" and she was told she was allergic; Initial information received on 25-Nov-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 60 years old female patient who experienced fatigue (fatigue), burning pain when her clothing touched her skin (pain),headache (headache), swelling in the right arm and arm pit (swelling), swollen glands in the back of her neck as well. (lymphadenopathy), didn't feel were normal (feeling abnormal), nerve pain in her right elbow (neuralgia), pain in the right side of her neck. (neck pain) and took "sulfa" and she was told she was allergic (drug hypersensitivity, while she received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 18-Oct-2019, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number UJ3243AC and Expiry date 30-Jun-2020 ) via unknown route in the right deltoid.  On an unknown date, the patient developed a non-serious fatigue, burning pain when her clothing touched her skin (pain),headache, swelling in the right arm and arm pit (swelling), swollen glands in the back of her neck as well. (lymphadenopathy), didn't feel were normal (feeling abnormal), nerve pain in her right elbow (neuralgia), pain in the right side of her neck. (neck pain) and took "sulfa" and she was told she was allergic (drug hypersensitivity) (Unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  (Other relevant tests included no lab data.) Final diagnosis was fatigue, Pain burning, headache, Local swelling, Glands swollen, Feeling abnormal, Nerve pain, Neck pain and Sulfonamide allergy.  The patient was treated with ACYCLOVIR [ACICLOVIR] (ACYCLOVIR [ACICLOVIR]).  The event outcome is reported as Unknown for all the events.  Information on the batch number was requested.
Sex: F
Vaccine: FLU4
Symptoms: Neck pain, Neuralgia, Pain, Peripheral swelling, Swelling
Clinical narrative: fatigue; burning pain when her clothing touched her skin; headache; swelling in the right arm and arm pit; swollen glands in the back of her neck as well.; didn't feel were normal; nerve pain in her right elbow; pain in the right side of her neck.; took "sulfa" and she was told she was allergic; Initial information received on 25-Nov-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 60 years old female patient who experienced fatigue (fatigue), burning pain when her clothing touched her skin (pain),headache (headache), swelling in the right arm and arm pit (swelling), swollen glands in the back of her neck as well. (lymphadenopathy), didn't feel were normal (feeling abnormal), nerve pain in her right elbow (neuralgia), pain in the right side of her neck. (neck pain) and took "sulfa" and she was told she was allergic (drug hypersensitivity, while she received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 18-Oct-2019, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number UJ3243AC and Expiry date 30-Jun-2020 ) via unknown route in the right deltoid.  On an unknown date, the patient developed a non-serious fatigue, burning pain when her clothing touched her skin (pain),headache, swelling in the right arm and arm pit (swelling), swollen glands in the back of her neck as well. (lymphadenopathy), didn't feel were normal (feeling abnormal), nerve pain in her right elbow (neuralgia), pain in the right side of her neck. (neck pain) and took "sulfa" and she was told she was allergic (drug hypersensitivity) (Unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  (Other relevant tests included no lab data.) Final diagnosis was fatigue, Pain burning, headache, Local swelling, Glands swollen, Feeling abnormal, Nerve pain, Neck pain and Sulfonamide allergy.  The patient was treated with ACYCLOVIR [ACICLOVIR] (ACYCLOVIR [ACICLOVIR]).  The event outcome is reported as Unknown for all the events.  Information on the batch number was requested.
Age: 15.0
Sex: U
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: nurses gave the Flubok to 15 year old patient / no AE; Initial information received on 03-Dec-2019 regarding an unsolicited valid non-serious case received from Non-HCP (Office Staff).  This case involves a 15 years old patient who received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot number and Expiry date unknown) via unknown route in unknown administration site on an unknown date.  The medical history, medical treatment(s), past vaccination(s) and family history were not provided.   It was an actual medication error case due to inappropriate age at vaccine administration.  It was reported that nurses gave the Flubok to 15 year old patient.  At the time of reporting no adverse reaction 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.  Information on the batch number was requested.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Insomnia, Mobility decreased, Pain
Clinical narrative: Reports that still hurts, cannot lift arm, and trouble sleeping
Age: 35.0
Sex: F
Vaccine: HEP, MMR
Symptoms: Injection site bruising, Injection site mass
Clinical narrative: 28 DAYS POST INJECTION, PATIENT STILL HAS A LUMP UNDER THE SKIN AND MILD BRUISE AT INJECTION SITE
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Foaming at mouth, Hypersomnia, Loss of consciousness, Malaise, Retching
Clinical narrative: Had shot. About 1 am got up to go to bathroom.  Don?t remember anything after that. Husband found me unconscious about ten feet away from bathroom. Couldn?t wake me up. He was shaking me really hard but I wasn?t responding.   After about five minutes I started to come to. He said I was foaming about the mouth.  Then I  felt sick and started to throw up but was just dry heaves. I crawled to bead and slept till the middle of the day and off and on till evening.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Unresponsive to stimuli
Clinical narrative: Had shot. About 1 am got up to go to bathroom.  Don?t remember anything after that. Husband found me unconscious about ten feet away from bathroom. Couldn?t wake me up. He was shaking me really hard but I wasn?t responding.   After about five minutes I started to come to. He said I was foaming about the mouth.  Then I  felt sick and started to throw up but was just dry heaves. I crawled to bead and slept till the middle of the day and off and on till evening.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Balance disorder, Burning sensation, Chills, Dyskinesia, Gait disturbance
Clinical narrative: jerking,  chills,shaking, burning from inside out, severe headaches, trouble with balance, walking, memory and vision
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Memory impairment, Tremor, Visual impairment
Clinical narrative: jerking,  chills,shaking, burning from inside out, severe headaches, trouble with balance, walking, memory and vision
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Contusion, Erythema, Fatigue, Headache
Clinical narrative: On next 2 days :   Bruised upper arm, sore arm, red swollen large area on arm,   Fatigue & nausea.  On Day 4:  Fatigue, headache, nausea, so took 1 Advil.  I hour later; Burning, itching hives over entire body.   Most intense in ears and side of face.   Took 2 Zyrtec and put cortisone cream on itching spots.   Day 5:  went to Dr.  she prescribed Zyrtec and Pepsid, twice a day for 5 days.  Symptoms are subsiding.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pain in extremity, Peripheral swelling, Pruritus, Urticaria
Clinical narrative: On next 2 days :   Bruised upper arm, sore arm, red swollen large area on arm,   Fatigue & nausea.  On Day 4:  Fatigue, headache, nausea, so took 1 Advil.  I hour later; Burning, itching hives over entire body.   Most intense in ears and side of face.   Took 2 Zyrtec and put cortisone cream on itching spots.   Day 5:  went to Dr.  she prescribed Zyrtec and Pepsid, twice a day for 5 days.  Symptoms are subsiding.
Age: 64.0
Sex: M
Vaccine: FLUR4
Symptoms: Blood thyroid stimulating hormone normal, Bradycardia, Dysphagia, Electrocardiogram abnormal, Full blood count normal
Clinical narrative: Patient reported swelling of the throat and swallowing difficulty after vaccine.  Patient was given Benadryl 50mg oral and dexamethasone 50mg IM.  No resolution of swelling, HR dropped from 68 to 48. Patient escorted to Emergency room for further treatment where he received  iv famotidine and po Zyrtec.  Discharged home, resolved. Returned to clinic two days later for recheck with provider.
Age: 64.0
Sex: M
Vaccine: FLUR4
Symptoms: Heart rate decreased, Metabolic function test normal, Pharyngeal swelling, Thyroxine free normal
Clinical narrative: Patient reported swelling of the throat and swallowing difficulty after vaccine.  Patient was given Benadryl 50mg oral and dexamethasone 50mg IM.  No resolution of swelling, HR dropped from 68 to 48. Patient escorted to Emergency room for further treatment where he received  iv famotidine and po Zyrtec.  Discharged home, resolved. Returned to clinic two days later for recheck with provider.
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Injection site pain
Clinical narrative: Pt developed pain at the injection site the morning after receiving the vaccine (about 24 hours later). 5 days later pt has two bruises on injection arm below injection spot and still complains of pain
Age: 70.0
Sex: U
Vaccine: FLU3, PNC13
Symptoms: Musculoskeletal disorder
Clinical narrative: Patient reports difficulty with use of right arm, believes a muscle issue.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Blood creatine phosphokinase normal, Injection site pain, Red blood cell sedimentation rate normal
Clinical narrative: severe, persistent left upper arm pain
Sex: U
Vaccine: PPV
Symptoms: Adverse reaction, Vaccination complication
Clinical narrative: reacted severely to the pneumococcal 23 and felt he/she was dying, whole body reaction; This spontaneous report was received from a physician via Pfizer (2019507561), and refers to a 66 year old patient of unknown gender. Information about the patient's medical history, concurrent conditions, concomitant medications and drug reactions or allergies was not provided.      On an unknown date, the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23), for prophylaxis (strength, dose, frequency, route, lot number and expiration date were not provided).         On an unknown date, the patient reacted severely to the pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) described as a whole body reaction and felt like dying (vaccination complication).      At the time of reporting, the outcome of vaccination complication was unknown.  Causality assessment was not provided.
Sex: F
Vaccine: VARZOS
Symptoms: Seizure
Clinical narrative: seizures; Information has been received from a lawyer regarding a case in litigation concerning a female patient (pt) of unknown age. The pt's pertinent medical history, concurrent conditions and concomitant medications were not provided. In 2011, the pt was inoculated with zoster vaccine live (ZOSTAVAX) for the long term-term prevention of shingles and zoster-related conditions. subsequent to inoculation, on an unknown date, the pt experienced seizures and was treated by a physician.  As a direct and proximate result of use of the zoster vaccine live (ZOSTAVAX) vaccine, the pt had and would continue suffering ongoing injuries, including but not limited to mental and physical pain, medical care and treatment. Also had significant medical and related expenses including but not limited to medical losses, and costs included 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. At the reporting time, the pt was not recovered from seizure and it was considered related to zoster vaccine live (ZOSTAVAX).  Upon internal review, seizure was considered a medically significant event.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer regarding a case in litigation concerning a female patient (pt) of unknown age. The pt's pertinent medical history, concurrent conditions and concomitant medications were not provided. In 2014, the pt was inoculated with zoster vaccine live (ZOSTAVAX) for the long term-term prevention of shingles and zoster-related conditions. Subsequent to inoculation, on an unknown date, the pt experienced shingles and was treated by a health care provider. As a direct and proximate result of use of the zoster vaccine live (ZOSTAVAX) vaccine, the pt had and would continue suffering ongoing injuries, including but not limited to mental and physical pain, medical care and treatment. Also, had significant medical and related expenses including but not limited to medical losses, and costs included 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. At the reporting time, the pt was not recovered from shingles and it was considered related to zoster vaccine live (ZOSTAVAX).
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse symptoms were reported in the patient; A patient received a dose of PROQUAD following a temperature excursion; Information has been received from a nurse regarding a patient of unknown age and gender. The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medications were not reported.  On an unknown date, the patient was vaccinated with improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant human albumin (rHA) (PROQUAD) as prophylaxis, (lot number S017239 with expiration date in 01-DEC-2020 which was reconstituted with properly stored sterile diluent (MERCK STERILE DILUENT) (route of administration, strength and anatomical location not reported).  On 04-DEC-2019, the mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was stored at a temperature range of 15 degrees Fahrenheit (°F) to 46 °F (-9°C to 8°C) (16.2F) for the time frame of 1 hour 30 minutes. There was no previous temperature excursion and the call was because of a data logger.  No adverse effects reported.
Sex: U
Vaccine: ANTH
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: The first 2 doses were given a year apart; No adverse event; Information received on 18NOV2019 from a consumer.  A patient was given "first 2 doses of BioThrax a year apart" (PT: Inappropriate schedule of product administration). No adverse event was reported following the administration of BioThrax. A consumer while approaching for the third shot of BioThrax, reported that the first two doses were given a year apart.  Action taken with BioThrax was not applicable.  The clinical outcome of the reported events was unknown.  Company Comment: As there was no AE reported in connection to the "Inappropriate schedule of product administration", the Company is unable to make a causality assessment.  There is limited information to fully evaluate the circumstances behind the inappropriate dosing schedule.; Sender's Comments: As there was no AE reported in connection to the "Inappropriate schedule of product administration", the Company is unable to make a causality assessment.  There is limited information to fully evaluate the circumstances behind the inappropriate dosing schedule.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Heart rate decreased
Clinical narrative: I was dizzy for about 4 months after receipt of the shot.  My heart rate dropped to about 60 per minute.  My usual heart rate is about 98.  I worked from home for about 1 month to avoid driving and possible adverse effects.
Age: 55.0
Sex: F
Vaccine: FLUC4
Symptoms: Abdominal discomfort, Chills, Nausea, Oropharyngeal pain, Throat tightness
Clinical narrative: Less than 5 minutes after the vaccine was administered patient developed chills and began shivering uncontrollably, teeth chattering, stomach felt uneasy and she became nauseated, sore throat and tightness.
Age: 46.0
Sex: M
Vaccine: FLU4
Symptoms: Pain, Pain in extremity
Clinical narrative: left arm started to hurt 1 week after injection. Continues to complain of pain when lifting arm.
Age: 18.0
Sex: F
Vaccine: FLUR4
Symptoms: Rash erythematous
Clinical narrative: red rash band around lower bicep
Age: 78.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Dizziness, Dyspnoea, Erythema, Injected limb mobility decreased
Clinical narrative: severe pain left shoulder for 5 days, limited movement of left arm for 5 days, redness and hives left arm for 4 days, cold symptoms, nausea, chills, shakes, dizziness for first 48 hours, shortness of breath and body aches
Age: 78.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Nasopharyngitis, Nausea, Pain, Tremor
Clinical narrative: severe pain left shoulder for 5 days, limited movement of left arm for 5 days, redness and hives left arm for 4 days, cold symptoms, nausea, chills, shakes, dizziness for first 48 hours, shortness of breath and body aches
Age: 78.0
Sex: F
Vaccine: PPV
Symptoms: Urticaria
Clinical narrative: severe pain left shoulder for 5 days, limited movement of left arm for 5 days, redness and hives left arm for 4 days, cold symptoms, nausea, chills, shakes, dizziness for first 48 hours, shortness of breath and body aches
Age: 2.0
Sex: F
Vaccine: TDAP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: None - Was given Tdap instead of Dtap  - no issues reported
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister
Clinical narrative: Patient received the 2nd dose in the series on 12/4/19 and on 12/8/19 she had a small patch of blisters appear on the left side of her face.  She described the blisters as the same appearance as her husband's active shingles case a few years ago.  She said that the blisters dried and are improving on 12/11/19, when she brought this to our attention.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Chills, Injection site erythema, Injection site induration, Injection site swelling, Nausea
Clinical narrative: Patient received vaccine on 12/9/2019 in the afternoon.  Early the next morning she started having fever, chills, redness and swelling at injection site.  She was nauseated and vomited once.  She had a fever at school that day and was sent home.  Seen in  our office on 12/11/2019 and still had some redness and induration at injection site.  Other symptoms had subsided
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Pyrexia, Vomiting
Clinical narrative: Patient received vaccine on 12/9/2019 in the afternoon.  Early the next morning she started having fever, chills, redness and swelling at injection site.  She was nauseated and vomited once.  She had a fever at school that day and was sent home.  Seen in  our office on 12/11/2019 and still had some redness and induration at injection site.  Other symptoms had subsided
Age: 48.0
Sex: F
Vaccine: FLUC4
Symptoms: Cellulitis, Mobility decreased, Vaccination complication
Clinical narrative: "This happened on November 16. I got a flu shot and didn't understand why he did it so high. I had to go to the emergency room cause i couldn't move my arm. I was diagnosed with cellulitis from the flu shot. Its a blood infection. I am on antibiotics now. I still can't move my arm. The pharmacist was a floater."
Age: 64.0
Sex: M
Vaccine: MNQ, PNC13, PPV
Symptoms: Wrong product administered
Clinical narrative: Pt was given PPSV23 vaccine instead of Meningococcal B vaccine, with PCV13 vaccine at the same visit.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Induration, Swelling
Clinical narrative: Right arm redness, swelling, hardness occurred after patient left clinic, went to ED that night. Was prescribed cephalexin and didn't take it. Used cold compresses without relief.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Right Upper Arm: 10cm x 5cm area of warmth/erythema, no enduration
Age: 46.0
Sex: M
Vaccine: FLU4
Symptoms: Chest X-ray, Chills, Cough, Dyspnoea, Fall
Clinical narrative: As I was driving home after receiving Flu vaccination at Pharmacy I began having trouble breathing but thought that it must be my imagination because I was reassured by the Pharmacist that the flu vaccination was safe.  I went to bed that evening and woke up around 8:00 A.m.  drenced in sweat, achey. feeling  sick.  As I stood up from bed I passed out  hitting my side and head on the ground.  When I awoke a few minutes later I stood up again and fell into the wall hitting my head a second time and then passing out again.  When I came to a few minutes later I tried to get off the floor again only to pass out again, falling back on the floor.  I don't remember each time I hit the floor as I fainted before that.  When I came to again,  minutes later I was finally able to get up.  I spent the day on the couch, achy, vomiting, sweating with the chills.  It is several weeks since I received the vaccination and I am still achy,  coughing non stop and vomiting if I eat anything to heavy.  I can definitely see how these vaccinations could end the life of a child,  unborn fetus, elderly person or someone who wasn't as healthy as I was before the vaccination.  I  cannot begin to describe the level of regret that I have about being foolish enough to have gotten this vaccination as I was the epitome of great health before the vaccination and now pray that my body will clear itself of this poison so I can be healthy the way I was before the flu vaccination.  I am reporting this in the hopes of preventing  someone else from suffering as I have.
Age: 46.0
Sex: M
Vaccine: FLU4
Symptoms: Head injury, Hyperhidrosis, Loss of consciousness, Malaise, Pain
Clinical narrative: As I was driving home after receiving Flu vaccination at Pharmacy I began having trouble breathing but thought that it must be my imagination because I was reassured by the Pharmacist that the flu vaccination was safe.  I went to bed that evening and woke up around 8:00 A.m.  drenced in sweat, achey. feeling  sick.  As I stood up from bed I passed out  hitting my side and head on the ground.  When I awoke a few minutes later I stood up again and fell into the wall hitting my head a second time and then passing out again.  When I came to a few minutes later I tried to get off the floor again only to pass out again, falling back on the floor.  I don't remember each time I hit the floor as I fainted before that.  When I came to again,  minutes later I was finally able to get up.  I spent the day on the couch, achy, vomiting, sweating with the chills.  It is several weeks since I received the vaccination and I am still achy,  coughing non stop and vomiting if I eat anything to heavy.  I can definitely see how these vaccinations could end the life of a child,  unborn fetus, elderly person or someone who wasn't as healthy as I was before the vaccination.  I  cannot begin to describe the level of regret that I have about being foolish enough to have gotten this vaccination as I was the epitome of great health before the vaccination and now pray that my body will clear itself of this poison so I can be healthy the way I was before the flu vaccination.  I am reporting this in the hopes of preventing  someone else from suffering as I have.
Age: 46.0
Sex: M
Vaccine: FLU4
Symptoms: Syncope, Vomiting
Clinical narrative: As I was driving home after receiving Flu vaccination at Pharmacy I began having trouble breathing but thought that it must be my imagination because I was reassured by the Pharmacist that the flu vaccination was safe.  I went to bed that evening and woke up around 8:00 A.m.  drenced in sweat, achey. feeling  sick.  As I stood up from bed I passed out  hitting my side and head on the ground.  When I awoke a few minutes later I stood up again and fell into the wall hitting my head a second time and then passing out again.  When I came to a few minutes later I tried to get off the floor again only to pass out again, falling back on the floor.  I don't remember each time I hit the floor as I fainted before that.  When I came to again,  minutes later I was finally able to get up.  I spent the day on the couch, achy, vomiting, sweating with the chills.  It is several weeks since I received the vaccination and I am still achy,  coughing non stop and vomiting if I eat anything to heavy.  I can definitely see how these vaccinations could end the life of a child,  unborn fetus, elderly person or someone who wasn't as healthy as I was before the vaccination.  I  cannot begin to describe the level of regret that I have about being foolish enough to have gotten this vaccination as I was the epitome of great health before the vaccination and now pray that my body will clear itself of this poison so I can be healthy the way I was before the flu vaccination.  I am reporting this in the hopes of preventing  someone else from suffering as I have.
Age: 12.0
Sex: F
Vaccine: FLUC4
Symptoms: Dizziness, Feeling abnormal, Loss of consciousness, Seizure, Syncope
Clinical narrative: Patient reported feeling funny after shot. Mom sat her down in chair and we continued to immunize her other child. About 3 minutes after patient received the shot she fainted face down on the floor and started convulsing. We immediately called 911. She was unconscious for ~15 seconds and then she woke up. She was aware of what happened and was just dizzy. She busted under her eye open and had a welt on her forehead. Paramedics arrived about 10 minutes later and she went to the hospital.
Age: 12.0
Sex: F
Vaccine: FLUC4
Symptoms: Urticaria
Clinical narrative: Patient reported feeling funny after shot. Mom sat her down in chair and we continued to immunize her other child. About 3 minutes after patient received the shot she fainted face down on the floor and started convulsing. We immediately called 911. She was unconscious for ~15 seconds and then she woke up. She was aware of what happened and was just dizzy. She busted under her eye open and had a welt on her forehead. Paramedics arrived about 10 minutes later and she went to the hospital.
Age: 1.42
Sex: M
Vaccine: DTAP, FLU4
Symptoms: Irritability, Pyrexia, Rash, Roseola, Vomiting
Clinical narrative: Fever that evening. Vomited one time 2 days later. Rash on trunk 3 days later. Rash spread to arms and legs 4 days later with increased fussiness. Rash had Roseola type pattern along with the typical course of rash after fever for roseola.
Age: 22.0
Sex: F
Vaccine: FLUR4
Symptoms: Injection site erythema, Injection site nodule, Injection site pruritus
Clinical narrative: The patient described her arm to be red in a significant portion of her arm around the injection site. The actual area the needle went in felt like a small hard spot, and her whole arm surrounding it was red and itchy. I asked her if it hurt, or felt warm or how it felt and she described it mainly as itchy which made me feel it was a reaction to the vaccination. I suggested benadryl and to monitor and if symptoms progressed any further to seek medical attention. Upon follow up, the patient had only been taking zyrtec and said the swelling did seem to be improved upon and did not seek any medical attention and she did not seem concerned anymore
Age: 3.0
Sex: M
Vaccine: DTAP
Symptoms: Contusion, Erythema, Induration, Tenderness
Clinical narrative: < 10 cm erythema and induration with central bruising whchich developed around 24 hours after the vaccinationand progressed. The patient was seen 3 days after; afebrile with no evidence of itching, ; no wheezing, no stridor was appreciated. Tenderness was present though the patient was still running in the office.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Hyperaesthesia, Influenza like illness, Injection site erythema, Injection site pain
Clinical narrative: Started 4 hours after injection, arm began to hurt and patient felt very tired so she layed down. Patient's arm hurt worse the next day and she work up with flu-like symptoms. Arm was very red and swollen from elbow up to shoulder and by the fourth day post-vaccination, it looked like she was severely sunburn and arm was sensitive to touch. Patient treated symptoms with rest and naproxen, but did not see a doctor. Patient is now 7 days post vaccination and arm redness and swelling has gone down, but is still tender/sore and patient still feels fatigued.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling
Clinical narrative: Started 4 hours after injection, arm began to hurt and patient felt very tired so she layed down. Patient's arm hurt worse the next day and she work up with flu-like symptoms. Arm was very red and swollen from elbow up to shoulder and by the fourth day post-vaccination, it looked like she was severely sunburn and arm was sensitive to touch. Patient treated symptoms with rest and naproxen, but did not see a doctor. Patient is now 7 days post vaccination and arm redness and swelling has gone down, but is still tender/sore and patient still feels fatigued.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Inflammation, Joint range of motion decreased, X-ray
Clinical narrative: Inflamed rotator cuff, extreme pain and restricted range of motion in left arm. Symptoms began day of injection and increasingly got worse to present day.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Nausea, Pain in extremity, Vomiting
Clinical narrative: The patient received her second Shingrix vaccine and reported arm soreness and nausea, vomiting, and diarrhea a few hours after receiving the vaccine. She did not report having any of these symptoms after her first Shingrix shot and so it was quite a surprise to the patient.
Age: 60.0
Sex: M
Vaccine: UNK
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Severe fatigue and arm pain beginning hours after vaccination and lasting about 3 days.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Peripheral swelling, Tenderness
Clinical narrative: SWELLING AND TENDERNESS BELOW THE INJECTION SITE. SHE CALLED ME THE MORNING OF 12/11/19 TO ASK ABOUT REDNESS AND SWELLING THAT SHE JUST NOTICED THIS MORNING BELOW THE INJECTION SITE.  I TOLD HER IT WAS MOST LIKELY A SIDE EFFECT OF THE SHOT AND TO COME IN IF SHE WAS CONCERNED AND I WOULD LOOK AT IT.  I SUGGESTED TAKING TYLENOL AND AN ANITHISTAMINE. SHE CAME INTO THE PHARMACY A FEW HOURS LATER. THE AREA ABOUT AN INCH BELOW AND TO THE LEFT OF THE INJECTION SITE WAS SLIGHTLY SWOLLEN AND RED. I COULDN'T TELL IF IT WAS WARM BUT SHE THOUGHT IT WAS.  I TOLD HER IT LOOKED MORE RED AND SWOLLEN THEN I WOULD EXPECT FROM JUST AN ADVERSE REACTION TO THE  SHOT. I AGAIN SUGGESTED TYLENOL AND CLARITIN BECAUSE SHE DID NOT TAKE IT EARLIER. I ALSO SUGGESTED SHE CALL HER DOCTOR OR GO TO A CLINIC TO HAVE IT LOOKED AT IF IT DOESN'T RESOLVE SOON OR IF IT GOT ANY WORSE. SHE CALLED HER DOCTOR FROM OUR PARKING LOT AND THE NURSE TOLD HER HE SAID IT WAS PROBABLY JUST AN ADVERSE REACTION TO THE SHOT, WHICH IS NORMAL, AND TO TAKE CLARITIN IN THE MORNING AND BENADRYL IN THE EVENING.
Age: 11.0
Sex: M
Vaccine: HPV9, MENB
Symptoms: Erythema, Pain, Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: bib mother states for redness and swelling on right arm  redness has not grown since yesterday. no pain. per pt itchy at times. no fever. arm is sore with movement.
Age: 23.0
Sex: M
Vaccine: TDAP
Symptoms: Burning sensation, Pyrexia
Clinical narrative: The patient initially reported feeling what he described as a "burning" feeling moving through his body.  About 30 minutes later, he stated that he was fine and he felt that he likely had a fever.