chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, COVID-19 pneumonia, Hypoxia, SARS-CoV-2 test positive
Clinical narrative: Pt fully vaccinated with both doses of the Moderna COVID-19 vaccine (on 3/11/2021 and 4/8/2021 respectively).  Pt later became ill with COVID 19 and was hospitalized.  PCR positive 9/14/2021.  Pt initially presented to smaller area in rural county, transferred here for a higher level of care (both on 9/27/2021).  Identified to have COVID related pneumonia and hypoxia.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure increased, Dizziness, Dysgeusia, Nausea, Retching
Clinical narrative: Dizziness, Nausea, headache, metallic taste in mouth
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Dysgeusia, Headache, Nausea
Clinical narrative: Dizziness, Nausea, headache, metallic taste in mouth
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: breakthrough case
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: breakthrough case
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Chills, Dehydration, Diarrhoea, Fatigue
Clinical narrative: Flu like symptoms, headache, nausea, fatigue, dehydration, fever, chills. Start of menstrual cycle out of normal expected cycle.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Menstruation irregular, Nausea, Pain, Vomiting
Clinical narrative: Flu like symptoms, headache, nausea, fatigue, dehydration, fever, chills. Start of menstrual cycle out of normal expected cycle.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Dehydration, Fatigue, Headache, Influenza like illness
Clinical narrative: Flu like symptoms, headache, nausea, fatigue, dehydration, fever, chills. Start of menstrual cycle out of normal expected cycle.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Menstrual disorder, Nausea, Pyrexia
Clinical narrative: Flu like symptoms, headache, nausea, fatigue, dehydration, fever, chills. Start of menstrual cycle out of normal expected cycle.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Syncope
Clinical narrative: Fainted within 3 minutes of the shot, vomiting upon consciousness, sent to ER
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood potassium decreased, Blood test, Chest X-ray, Computerised tomogram, Concussion
Clinical narrative: Fainted within 3 minutes of the shot, vomiting upon consciousness, sent to ER
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Echocardiogram, Electrocardiogram, Loss of consciousness, Syncope, Vomiting
Clinical narrative: Fainted within 3 minutes of the shot, vomiting upon consciousness, sent to ER
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash
Clinical narrative: Immediately after the first shot: rash in both palms of the hands/Rash back of the thighs/Rash behind the calves/Rash in ankles/Rash in thighs/Rash in her legs (late August and ongoing); red dots/very red; very itchy; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Immediately after the first shot: rash in both palms of the hands/Rash back of the thighs/Rash behind the calves/Rash in ankles/Rash in thighs/Rash in her legs (late August and ongoing)), ERYTHEMA (red dots/very red) and PRURITUS (very itchy) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH (Immediately after the first shot: rash in both palms of the hands/Rash back of the thighs/Rash behind the calves/Rash in ankles/Rash in thighs/Rash in her legs (late August and ongoing)), ERYTHEMA (red dots/very red) and PRURITUS (very itchy). The patient was treated with IBUPROFEN ongoing since an unknown date for Adverse event, at an unspecified dose and frequency; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL ITCH) ongoing since an unknown date for Adverse event, at an unspecified dose and frequency and CORTISONE ongoing since an unknown date for Adverse event, at an unspecified dose and frequency. At the time of the report, RASH (Immediately after the first shot: rash in both palms of the hands/Rash back of the thighs/Rash behind the calves/Rash in ankles/Rash in thighs/Rash in her legs (late August and ongoing)) was resolving and ERYTHEMA (red dots/very red) and PRURITUS (very itchy) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No Concomitant Medications were provided by the reporter   This case was linked to MOD-2021-324048 (Patient Link).
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema, Pruritus, Rash
Clinical narrative: Immediately after the first shot: rash in both palms of the hands/Rash back of the thighs/Rash behind the calves/Rash in ankles/Rash in thighs/Rash in her legs (late August and ongoing); red dots/very red; very itchy; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Immediately after the first shot: rash in both palms of the hands/Rash back of the thighs/Rash behind the calves/Rash in ankles/Rash in thighs/Rash in her legs (late August and ongoing)), ERYTHEMA (red dots/very red) and PRURITUS (very itchy) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH (Immediately after the first shot: rash in both palms of the hands/Rash back of the thighs/Rash behind the calves/Rash in ankles/Rash in thighs/Rash in her legs (late August and ongoing)), ERYTHEMA (red dots/very red) and PRURITUS (very itchy). The patient was treated with IBUPROFEN ongoing since an unknown date for Adverse event, at an unspecified dose and frequency; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL ITCH) ongoing since an unknown date for Adverse event, at an unspecified dose and frequency and CORTISONE ongoing since an unknown date for Adverse event, at an unspecified dose and frequency. At the time of the report, RASH (Immediately after the first shot: rash in both palms of the hands/Rash back of the thighs/Rash behind the calves/Rash in ankles/Rash in thighs/Rash in her legs (late August and ongoing)) was resolving and ERYTHEMA (red dots/very red) and PRURITUS (very itchy) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No Concomitant Medications were provided by the reporter   This case was linked to MOD-2021-324048 (Patient Link).
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Death, Headache, Pain, Pain in extremity
Clinical narrative: sore shoulder, body ache, headache, legs hurt, death
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Death, Headache, Pain, Pain in extremity
Clinical narrative: sore shoulder, body ache, headache, legs hurt, death
Age: 78.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Hypoxia, SARS-CoV-2 test positive
Clinical narrative: ended up with covid +, requiring hospitalization
Age: 78.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: ended up with covid +, requiring hospitalization
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Diarrhoea, Headache, Injection site erythema, Pruritus, Rash
Clinical narrative: Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Headache-Mild
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Headache-Mild
Age: 77.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Erythema
Clinical narrative: HER HUSBAND SAYS SHE WOKE UP THE NEXT DAY WITH REDNESS AND SORENESS ON THE INNER ASPECT OF  HER LEFT ARM (THE ARM SHE GOT THE SHOT IN). THE AREA WAS ABOUT 6 INCHES LONG. AS OF 9-30-21 SHE STILL HAS A RASH.
Age: 77.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Injection site erythema, Injection site pain, Rash
Clinical narrative: HER HUSBAND SAYS SHE WOKE UP THE NEXT DAY WITH REDNESS AND SORENESS ON THE INNER ASPECT OF  HER LEFT ARM (THE ARM SHE GOT THE SHOT IN). THE AREA WAS ABOUT 6 INCHES LONG. AS OF 9-30-21 SHE STILL HAS A RASH.
Age: 85.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: PATIENT RECEIVED PFIZER AFTER PREVIOUSLY RECIEVING JANSEN
Age: 50.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Extra dose administered, Interchange of vaccine products, Wrong product administered
Clinical narrative: I was suppose to receive a flu vaccine and instead received a COVID shot:  I already had my two COVID Moderna vaccines and did not require additional COVID shot  I had rapid heart rate, fatigue, muscle pain and emotional distress, sleeplessness and anxiety: I have mood swings and depression
Age: 50.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Anxiety, Depression, Emotional distress, Extra dose administered, Fatigue
Clinical narrative: I was suppose to receive a flu vaccine and instead received a COVID shot:  I already had my two COVID Moderna vaccines and did not require additional COVID shot  I had rapid heart rate, fatigue, muscle pain and emotional distress, sleeplessness and anxiety: I have mood swings and depression
Age: 50.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Heart rate increased, Insomnia, Interchange of vaccine products, Mood swings, Myalgia
Clinical narrative: I was suppose to receive a flu vaccine and instead received a COVID shot:  I already had my two COVID Moderna vaccines and did not require additional COVID shot  I had rapid heart rate, fatigue, muscle pain and emotional distress, sleeplessness and anxiety: I have mood swings and depression
Age: 50.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Wrong product administered
Clinical narrative: I was suppose to receive a flu vaccine and instead received a COVID shot:  I already had my two COVID Moderna vaccines and did not require additional COVID shot  I had rapid heart rate, fatigue, muscle pain and emotional distress, sleeplessness and anxiety: I have mood swings and depression
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, Swelling face
Clinical narrative: Swelling of the face; rash on face and left arm; This is a spontaneous report from a non-contactable consumer (patient). A 79-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Solution for injection), via an unspecified route of administration, administered in the left arm, on 17Feb2021 15:00 (Batch/lot number: EL9266), at age 79 years old, as dose 1, single. Relevant medical history was reported as none. The patient did not have COVID-19 prior to vaccination and was not tested for COVID-19 post vaccination. The patient has no known allergies. Concomitant medications were not reported. The patient did not receive other vaccines in four weeks. On 20Feb2021, the patient experienced swelling of the face and rash on face and left arm. The events resulted to doctor or other healthcare professional office/clinic visit. Treatment for the events included steroid pills and vitamin D shot. The patient was recovering from the events.   No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine administered 12 hours post puncture; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered 12 hours post puncture) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered 12 hours post puncture). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administered 12 hours post puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Nurse said the vaccine had not expired since Expiration Date was for next year. However, the vial was first punctured on 02-Sep-2021 at 1:20pm. It was removed from the refrigerator two times for about 10 minutes each time. The vial did not undergo any previous excursion.  No concomitant medication was provided.  No treatment medication was provided.  First dose was administered on 17SEP2021, it was the first dose for the patient, the patient has not called to report any adverse effects.   This case was linked to MOD-2021-326530 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 22-Sep-2021: Follow up received, Containing Non significant Information
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: ache in chest; This is a spontaneous report from a contactable consumer (patient). A 64-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: Unknown, Expiration date: Not reported), via an unspecified route of administration on 22Mar2021 at 13:45 (at the age of 64-years-old) as unknown dose, single for COVID-19 immunization. The patient had no medical history. The patient was allergic to bupropion (WELBUTRIN). Concomitant medication included sildenafil citrate (VIAGRA). The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not tested for COVID-19. On 22Mar2021 at 16:00, probably 2 to 3 hours after the vaccination, the patient started to feel an ache in the center of the chest just under the sternum. The event persisted and slowly grew in intensity. In the morning hours, the event kept the patient away from getting any sleep. On a scale of 1 to 10, the patient was rating the pain as 4 when in a steady state and 6 to 8 when on spike. The patient drank a few glasses of water thinking it was due to his digestive tract but it had no effect. As a distraction from the pain, the patient decided to start breathing very deeply and after a while the patient noticed a diminished level of pain. The patient did this because he heard of blood clots with another vaccine and figured by breathing heavy, it might bring more oxygen or blood to clear out an obstruction. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive treatment for the reported event. The patient wanted to share his experience in case this simple technique would help. The clinical outcome for chest pain was unknown at the time of report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: VARZOS
Symptoms: Blindness unilateral, Emotional distress, Optic ischaemic neuropathy, Optic neuritis
Clinical narrative: vision loss; optic neuritis; her husband developed "nonartritic ischemic optic neuropathy" (right side lost vision); Information has been received from a wife concerning her 64-year-old husband with no known drug allergies, who on 19-JUN-2008 was vaccinated with zoster vaccine live (Oka/Merck) 0.65 ml, for the prevention of shingles. Concomitant therapy included doxycycline, atorvastatin calcium (LIPITOR), vitamins (unspecified), ubiquinones (unspecified)(Coenzyme Q), ibuprofen (MOTRIN), minerals (unspecified) (+) vitamins (unspecified) (CENTRUM) and "Ecatrum" (therapy unspecified). The wife reported that on 25-JUN-2008, her husband developed "nonartritic ischemic optic neuropathy" (right side lost vision) after getting the zoster vaccine live (Oka/Merck) vaccine. The patient sought medical attention. On unspecified visual test was performed (date and results not reported). At the time of the report the patient's nonarteric ischemic optic neuropathy (right side lost vision) persisted.  Follow-up information has been received on 22-SEP-2021 from a lawyer regarding a case in litigation. The patient's concurrent conditions, medical history, drug reactions or allergies were not reported. On an unspecified date, the pt was inoculated with Zoster Vaccine Live (ZOSTAVAX) vaccine for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). After vaccination, the pt suffered vision loss and optic neuritis. As a result of these symptoms, the pt was seen and treated by (unspecified) medical providers and was still under their care. As a direct and proximate result of Zoster Vaccine Live (ZOSTAVAX) vaccine, the patient symptoms had resulted in physical limitations not presented prior to using Zoster Vaccine Live (ZOSTAVAX). The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and or sale of Zoster Vaccine Live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence the patient suffered serious, progressive, permanent and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, the patient had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. At the reporting time, the outcome of the events was considered as not recovered. The reporter considered the events to be related to Zoster Vaccine Live (ZOSTAVAX).  Upon internal review, optic ischaemic neuropathy, blindness and optic neuritis were determined to be medically significant event.   The reporter considered blindness and optic neuritis to be disabling events.
Age: 47.0
Sex: M
Vaccine: HPV9
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: The patient was monitored for 30 minutes after administration and had no issues; 47 years old male patient received a dose of GARDASIL 9; This spontaneous report was received from a registered nurse referring to a 47 years old male patient. The patient had not received any vaccines four weeks prior. No illness at time of vaccination was reported. No significant past medical history was reported. It was unknown if patient had concomitant medications.  On 14-SEP-2021, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (1 dose, lot# 1637651, expiration date 09-JUN-2022; strength and route of administration were not reported) in left deltoid for prophylaxis (product administered to patient of inappropriate age). The patient had never received any other doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). No other vaccines were administered on this date. The patient was monitored for 30 minutes after administration and had no issues. The patient was told to call if he had any adverse reaction and patient had not called. No product quality complaints was reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1637651; expirationdate: 09-JUN-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: lmproperly stored PROQUAD administered to a patient.; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.   On 25-JUL-2021, the measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) lot # T016990, expiration date 11-NOV-2021 experienced the temperature excursion of 6 to 14 degrees Fahrenheit (7.3F) for 37 minutes. On 24-AUG-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # T016990, 0.5 mL subcutaneously x 1 dose (formulation, strength, frequency and route of administration were not reported) or prophylaxis (product storage error). No product quality complain reported. On 14-SEP-2021, the vaccine experienced temperature excursion of 6 to 14 (9.9F) or 2 hours and 11 minutes. On 15-SEP-2021, the vaccine experienced temperature excursion of 6 to 14 (6.6F) for 59 minutes.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: Nurse reporting a temperature excursion for PROQUAD. Information obtained for vaccines that were administered to patients.; This spontaneous report has been received from a nurse referring to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, drug reactions or allergies and concomitant medications were not reported.   On an unknown date, the patient was vaccinated with an improperly stored dose (Product storage error) of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), 0.5 ml, subcutaneous (SQ), lot # T016990 with expiration date 11-NOV-2021, for prophylaxis.   On 25-JUL-2021, a temperature excursion was occurred from 6°F to 14°F (7.3°F) during a time frame of 37 minutes. This temperature excursion was not previously reported.  On 10-AUG-2021, the product storage error was identified.  On 14-SEP-2021, a temperature excursion was occurred from 6°F to 14°F (9.9°F) during a time frame of 2 hours and 11 minutes.  On 15-SEP-2021, a temperature excursion was occurred from 6°F to 14°F (6.6°F) during a time frame of 59 minutes.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: Nurse reporting a temperature excursion for PROQUAD. Information obtained for vaccines that were administered to patients.; This spontaneous report has been received from a nurse referring to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, drug reactions or allergies and concomitant medications were not reported.   On an unknown date, the patient was vaccinated with an improperly stored dose (Product storage error) of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), 0.5 ml, subcutaneous (SQ), lot # T016990 with expiration date 11-NOV-2021, for prophylaxis.   On 25-JUL-2021, a temperature excursion was occurred from 6°F to 14°F (7.3°F) during a time frame of 37 minutes. This temperature excursion was not previously reported.  On 06-AUG-2021, the product storage error was identified.  On 14-SEP-2021, a temperature excursion was occurred from 6°F to 14°F (9.9°F) during a time frame of 2 hours and 11 minutes.  On 15-SEP-2021, a temperature excursion was occurred from 6°F to 14°F (6.6°F) during a time frame of 59 minutes.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: lmpropely stored vaccine administered (37.94 F); This spontaneous report was received from a licensed practical nurse and refers to a 4-year-old female patient. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided.  On 20-AUG-2021, the patient was vaccinated in a public health clinic by the reporter (described also as a trained operator) with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot # T002847, expiration date 23-JAN-2022 (dose number, dose, route of administration were not reported) for prophylaxis (product storage error). The administered vaccine was stored in clinical practice in a temperature of 37.94 degree Fahrenheit (F) for 100 hours. There was no previous temperature excursion. Digital data logger was involved. No prescription drug treatment for the experience was required. Temperature excursion detected vaccine was removed immediately after the reporting and no further vaccine was administered. The patient's parents were notified and the vaccination would be repeated with new vaccine stock.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2108USA006311:
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Dysstasia, Fatigue, Feeling abnormal, Gastrointestinal disorder, Hormone level abnormal
Clinical narrative: Patient reported 9/29/21 having  multiple "extreme" reactions to 1st dose. ie: Brain fog,shaking,arm pain,"not able to function/stand",decreased quality of life,"hormonal",nausea,fatigue,bowel problems.I explained I did not feel comfortable giving her the 2nd dose based on her complaints and referred her to the PCP for her health and safety.She said she didn't want the first dose,but was "forced" to get it by her employer.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of personal independence in daily activities, Nausea, Pain in extremity, Quality of life decreased, Tremor
Clinical narrative: Patient reported 9/29/21 having  multiple "extreme" reactions to 1st dose. ie: Brain fog,shaking,arm pain,"not able to function/stand",decreased quality of life,"hormonal",nausea,fatigue,bowel problems.I explained I did not feel comfortable giving her the 2nd dose based on her complaints and referred her to the PCP for her health and safety.She said she didn't want the first dose,but was "forced" to get it by her employer.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Patient reported 9/29/21 having  multiple "extreme" reactions to 1st dose. ie: Brain fog,shaking,arm pain,"not able to function/stand",decreased quality of life,"hormonal",nausea,fatigue,bowel problems.I explained I did not feel comfortable giving her the 2nd dose based on her complaints and referred her to the PCP for her health and safety.She said she didn't want the first dose,but was "forced" to get it by her employer.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Hyperhidrosis, Lymphadenopathy, Myalgia
Clinical narrative: Ipsilateral supraclavicular lymphadenopathy starting 1 day after injection, peaking at >1cm diameter on day 3. This also occurred over a similar timeline with injection #2. All injections were taken in left arm. Injection site #3 did not appear to be outside recommended distance from deltoid muscle belly.  Patient also had rigors, diaphoresis, subjective fever, headache, and severe cervical and lumbar muscular pain that mostly resolved by day 3. These symptoms were not present after vaccination 1 or 2.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Ultrasound scan
Clinical narrative: Ipsilateral supraclavicular lymphadenopathy starting 1 day after injection, peaking at >1cm diameter on day 3. This also occurred over a similar timeline with injection #2. All injections were taken in left arm. Injection site #3 did not appear to be outside recommended distance from deltoid muscle belly.  Patient also had rigors, diaphoresis, subjective fever, headache, and severe cervical and lumbar muscular pain that mostly resolved by day 3. These symptoms were not present after vaccination 1 or 2.
Age: 75.0
Sex: M
Vaccine: UNK
Symptoms: Cardiac arrest, Chills, Diarrhoea, Fatigue, Nausea
Clinical narrative: Sudden Cardiac Arrest - after feeling nausea, diarrhea, chills and fatigue.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Gait inability, Insomnia, Pain in extremity
Clinical narrative: I am currently experience a severe legs pain, especially on the back of my left leg, and at the bottom of my right foot to the point that I can't walk or sleep at night.  I shared this info with my family doctor, he did not offer any advice.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Erythema, Feeling hot, Pain in extremity, Peripheral swelling
Clinical narrative: My upper arm is swollen, bruised, hot, itchy, red and painful
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: My upper arm is swollen, bruised, hot, itchy, red and painful
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Bradycardia, Burning sensation, C-reactive protein decreased, Chest X-ray normal, Chest pain
Clinical narrative: 4 days after 2 dose. Forceful pounding heart.  Heart palpitations. Chest pains.  Shortness of breath. Fatigue. Burning sensation around heart.  Heart rate 40-50 bpm.  No treatment available.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Echocardiogram abnormal, Fatigue, Palpitations, Red blood cell sedimentation rate normal
Clinical narrative: 4 days after 2 dose. Forceful pounding heart.  Heart palpitations. Chest pains.  Shortness of breath. Fatigue. Burning sensation around heart.  Heart rate 40-50 bpm.  No treatment available.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Troponin normal
Clinical narrative: 4 days after 2 dose. Forceful pounding heart.  Heart palpitations. Chest pains.  Shortness of breath. Fatigue. Burning sensation around heart.  Heart rate 40-50 bpm.  No treatment available.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Gout
Clinical narrative: Gout on second day after receiving second vaccine
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Pain, Pruritus, Rash
Clinical narrative: Rash with intense itching for 21 days, general malaise and achyness for 10 days after shot.  This rash appeared in small red dots about 1/8th inch in diameter, showing in circles about an inch in diameter.  Extreme itch and soreness underneath the rash for sever days after which the rash would fade.  The worst on was under my left arm, went on for 5 days.
Age: 41.0
Sex: F
Vaccine: FLUC4
Symptoms: Abdominal pain, Diarrhoea, Erythema, Hyperhidrosis, Injection site pruritus
Clinical narrative: Erythema, edema, pruritis at injection site Diaphoresis Nausea  Vomiting  Diarrhea Abdominal pain
Age: 41.0
Sex: F
Vaccine: FLUC4
Symptoms: Nausea, Oedema, Vomiting
Clinical narrative: Erythema, edema, pruritis at injection site Diaphoresis Nausea  Vomiting  Diarrhea Abdominal pain
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Infection, Tinnitus
Clinical narrative: I never have had COVID until I received the vaccine I was diagnosed on 13 I now have had a severe infection  after that has been treated with two different  antibiotics and still has not been resolved. I also started having tinnitus..
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Fatigue, Headache, Pain in extremity, SARS-CoV-2 test negative
Clinical narrative: Loss of taste. Fatigue. Headache. Arm soreness. Covid tested with negative result for loss of taste.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash erythematous, Skin warm
Clinical narrative: A red, hot rash appeared on the left side of my torso as well as all over both of my arms and legs.
Age: 62.0
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Ill-defined disorder
Clinical narrative: Other zoster-related conditions; Shingles; Information has been received from a Lawyer, referring to a currently 68 year old patient. Information regrading the patient's pertinent medical history, concurrent conditions, known allergies and concomitant therapies was not provide. On and or about 01-OCT-2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX), by a physician (route, dose, strength, lot # and expiration date were not provided)for the long-term prevention of shingles and zoster-related conditions. On an unknown date, the patient was treated by a healthcare provided for shingles (herpes zoster) and other zoster-related conditions (ill-defined disorder). The patient claimed damages as a result of injury to themselves, loss of consortium and loss of services. At the time of the report, the outcome of herpes zoster and ill-defined disorder was unknown. The lawyer determined that herpes zoster and ill-defined disorder were related to Zoster Vaccine Live (ZOSTAVAX).
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: Moderna 3rd dose (additional dose) administered to patient that is not indicated to receive additional dose as patient is not taking any medications and only has history of IBD. Patient did not indicate that she was immunocompromised on consent form.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Eye pruritus, Headache, Hemiparesis, Lacrimation increased
Clinical narrative: Left side neuropathy and weakness Chills Headache Watery and itchy left eye Muscle aches
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Neuropathy peripheral
Clinical narrative: Left side neuropathy and weakness Chills Headache Watery and itchy left eye Muscle aches
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Sleep disorder, Tinnitus
Clinical narrative: Ringing in ears awoke me from sound sleep within 12 hours from injection.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Acute motor-sensory axonal neuropathy, Computerised tomogram normal, Fine motor skill dysfunction, Grip strength decreased, Loss of personal independence in daily activities
Clinical narrative: April 10th: Woke up with  "pins and needles"  feeling sensation on all fingertips on my right hand for the entire day.   Woke up the next day sensation went away.     May 13th: Woke up with fingertips on both hands feeling the same   "pins and needles" sensation.   This  "pins and needles"  sensation  is still occurring to this day.  June 13th: I noticed that it was difficult  to turn door knobs, water faucets, and hold certain objects. This phenomenon  got worse and worse  until June 20th where I lost the ability to move my wrists up and had trouble moving my fingers.  Because of this, it is difficult for me grip certain objects, hold on to object such as a glass of water, or even type properly on a keyboard. This is still happening today.  Neurologist have diagnosed me with Acute motor sensory axonal neuropathy, a variant of Guillain-Barré syndrome.  I also began seeing an occupational therapist to help me with day-to-day things like clean myself.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Magnetic resonance imaging spinal normal, Mobility decreased, Nerve stimulation test abnormal, Paraesthesia, Spinal X-ray normal
Clinical narrative: April 10th: Woke up with  "pins and needles"  feeling sensation on all fingertips on my right hand for the entire day.   Woke up the next day sensation went away.     May 13th: Woke up with fingertips on both hands feeling the same   "pins and needles" sensation.   This  "pins and needles"  sensation  is still occurring to this day.  June 13th: I noticed that it was difficult  to turn door knobs, water faucets, and hold certain objects. This phenomenon  got worse and worse  until June 20th where I lost the ability to move my wrists up and had trouble moving my fingers.  Because of this, it is difficult for me grip certain objects, hold on to object such as a glass of water, or even type properly on a keyboard. This is still happening today.  Neurologist have diagnosed me with Acute motor sensory axonal neuropathy, a variant of Guillain-Barré syndrome.  I also began seeing an occupational therapist to help me with day-to-day things like clean myself.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Angina pectoris, Chest discomfort, Chest pain
Clinical narrative: Mikd heartache, continous pain / tightness in chest, lasted 2 days.
Age: 25.0
Sex: F
Vaccine: FLU4
Symptoms: Insomnia, Pain in extremity, Pyrexia, Swelling
Clinical narrative: Severe left arm pain and swelling of left armpit the morning following the injection - treatable with over-the-cover pain medication but recurring throughout the day. Fever for the entire day following the injection, peaking at 102.7 degrees but typically hovering around 100-101 degrees. Insomniac episode during the night of the 29th, potentially related to the fever.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Acute respiratory failure, Atrial fibrillation, Cerebral artery embolism, Cerebrovascular accident, Headache
Clinical narrative: After having his 2nd Covid shot, my father was complaining of headaches and a stiff neck.  Exactly 2 weeks after having the 2nd Covid shot, my father had a stroke while driving which caused an accident.  He was rushed to a Trauma Center for *Cerebrovascular accident (CVA) due to embolism of left middle cerebral artery, *Atrial Fibrillation Paroxysmal, and  *Acute Respiratory failure with hypoxia,
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Impaired driving ability, Musculoskeletal stiffness, Road traffic accident
Clinical narrative: After having his 2nd Covid shot, my father was complaining of headaches and a stiff neck.  Exactly 2 weeks after having the 2nd Covid shot, my father had a stroke while driving which caused an accident.  He was rushed to a Trauma Center for *Cerebrovascular accident (CVA) due to embolism of left middle cerebral artery, *Atrial Fibrillation Paroxysmal, and  *Acute Respiratory failure with hypoxia,
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dizziness, Dyspnoea, Echocardiogram, Electrocardiogram ambulatory
Clinical narrative: Near fainting on 8/23/21 then on 8/24/21 my heart rate was in the 170s when doing simple tasks. I was having drastic increases in heart rate from laying to sitting and sitting to standing (80 when laying and 130 when standing up) To this day I am still dealing with a rapid heart rate, typically in the 130s-150s when walking and doing simple things (no previous medical history or cardiac issues). Chest pain and shortness of breath accompanies the tachycardia.   Extreme fatigue and dizziness accompany the rapid heart rate while exerting and when I have been working all day  As of right now I am taking Metoprolol to try and being down my heart rate (still in the 120's-130's with simple activities) even with an increased dose of Metoprolol
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Heart rate increased, Laboratory test, Presyncope, Tachycardia
Clinical narrative: Near fainting on 8/23/21 then on 8/24/21 my heart rate was in the 170s when doing simple tasks. I was having drastic increases in heart rate from laying to sitting and sitting to standing (80 when laying and 130 when standing up) To this day I am still dealing with a rapid heart rate, typically in the 130s-150s when walking and doing simple things (no previous medical history or cardiac issues). Chest pain and shortness of breath accompanies the tachycardia.   Extreme fatigue and dizziness accompany the rapid heart rate while exerting and when I have been working all day  As of right now I am taking Metoprolol to try and being down my heart rate (still in the 120's-130's with simple activities) even with an increased dose of Metoprolol
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia, Pain in extremity, Paraesthesia, Restlessness
Clinical narrative: I had pain on my left should for couple of days but it was expected. And I started having joint pain on my feet and hands but It was sporadic and can be ignored. But maybe after 3 weeks from the 1sf shot, I started having  tingling sensation on my left leg and arm.  It started at night, and I was restless and had to do something. The frequency became more often, especially at night. I remember I woke up at 3 am and had to walk to calm it down. I thought it could go away but still have it. I had to climb a ladder several time for house work yesterday and noticed left leg has stronger muscle pain compared to right  leg.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: I had vertigo for couple of nights.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Fatigue, Impaired driving ability, Impaired work ability, Presyncope
Clinical narrative: Near syncope 12 minutes after injection. Seizure 2 pm following day. Seizure approximately 9 that night. Fatigue, fever.  Called dr the next morning and the nurse said to rest and not to drive  or go to work and as long as I was feeling better and improving that it would be ok. Blurry vision x 2 weeks and still not all the way better.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Seizure, Vision blurred
Clinical narrative: Near syncope 12 minutes after injection. Seizure 2 pm following day. Seizure approximately 9 that night. Fatigue, fever.  Called dr the next morning and the nurse said to rest and not to drive  or go to work and as long as I was feeling better and improving that it would be ok. Blurry vision x 2 weeks and still not all the way better.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Allergy to arthropod sting
Clinical narrative: Severe allergic reaction to a bee sting 4 months following vaccine.  No previous reaction to bee stings.  Resulted in an emergency room visit.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Diarrhoea, Fatigue, Headache, Pain in extremity
Clinical narrative: I took no medications before the shot. Then, around 7 PM, I had a fever of 100, diarrhea, a terrible headache, and a  very painful arm. I am still running a low-grade fever and I am very tired and no energy.  I am the only one in my family that gets sick. Shot number one I got sick but not that bad and shot number two it was a little worse but this one is much worse.. I know I'll get over it but I am concerned I get so sick and the rest of my family has a slightly sore arm.  Does that mean the shots are not doing me any good?
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: I took no medications before the shot. Then, around 7 PM, I had a fever of 100, diarrhea, a terrible headache, and a  very painful arm. I am still running a low-grade fever and I am very tired and no energy.  I am the only one in my family that gets sick. Shot number one I got sick but not that bad and shot number two it was a little worse but this one is much worse.. I know I'll get over it but I am concerned I get so sick and the rest of my family has a slightly sore arm.  Does that mean the shots are not doing me any good?
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Impaired work ability, Pain in extremity, Pyrexia
Clinical narrative: 105 degree temp 10 hrs after injection. Extreme arm pain for 96 hrs.   Fever/temp, controlled over 24 hrs.  Nurse advice line said to go in if it stayed over 104 for more than 2 hrs and to control with Motrin.   Peak of 105, then hovered around 100-103 over 12 hrs.   Out of work for 4 days.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: Chest Pain - have not yet went to see a doctor.
Age: 29.0
Sex: F
Vaccine: FLUX
Symptoms: Fatigue, Feeling hot, Induration, Limb mass, Peripheral swelling
Clinical narrative: Increased fatigue. Warm, swollen, hard lump at left arm that itches and is getting bigger still nearly 48 hours later.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dyspnoea, Fatigue, Laboratory test, Pain
Clinical narrative: skin rash, fever, chills, shortness of breath, palpitations, body aches, fatigue
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Palpitations, Pyrexia, Rash
Clinical narrative: skin rash, fever, chills, shortness of breath, palpitations, body aches, fatigue
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Pyrexia
Clinical narrative: Fever, headache, myalgias that are persisting after 24 hours post vaccine
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary pain, Chest pain, Injection site pain, Injection site swelling, Swelling
Clinical narrative: swelling and pain from injection site into axilla and upper chest
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Ultrasound scan
Clinical narrative: swelling and pain from injection site into axilla and upper chest
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Impaired quality of life, Laboratory test, Paraesthesia, Tachycardia
Clinical narrative: Went to  ER four  times  beginning  on 7/11/2021 was diagnosed with  Parenthesis and Tachycardia  almost hospitalized on 7/15/2021. I am still suffered from  Tachycardia and Parenthesis  and can no longer compete as a swimmer.  This has affected my life
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Urine analysis, X-ray
Clinical narrative: Went to  ER four  times  beginning  on 7/11/2021 was diagnosed with  Parenthesis and Tachycardia  almost hospitalized on 7/15/2021. I am still suffered from  Tachycardia and Parenthesis  and can no longer compete as a swimmer.  This has affected my life
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dysmenorrhoea, Heavy menstrual bleeding, Thrombosis
Clinical narrative: Heavier flow during menstruation since vaccination More clotting during menstruation since vaccination Increased duration of menstruation since vaccination More cramping and diarrhea during and immediately prior to menstruation since vaccination
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiovascular evaluation, Costochondritis, Electrocardiogram normal, Musculoskeletal chest pain, Troponin I normal
Clinical narrative: 20 Sep--developed rib pain and went to ED; pain was sig 6/10; now a 2/10; cardiac eval neg; dx'ed w/ costochondritis.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported; PNEUMOV AX 23 expired on 12/22/2020 and was administered; This spontaneous report was received from a Nurse refers to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, known allergies and concomitant therapies were not provided.      On 22-SEP-2021, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) 0.5mL, with lot # S003872 and expiration date on 22-DEC-2020 (dose and route were not reported) for prophylaxis (expired product administered).  No additional adverse events were reported. No additional information provided.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Dizziness, Fatigue, Headache, Hyperhidrosis
Clinical narrative: Began to experience fatigue and joint pain/aching around 5:00 PM, which worsened as time progressed. Took 1,000 mg of acetaminophen at 6:00 PM. Attempted to sleep around 9:00 PM, but the pain and fatigue was still too much. At approximately 9:30 PM, fatigue and joint pain suddenly increased.  Began to experience the beginning stages of a fainting episode: Dizziness, Light-headedness, Perspiration, Nausea, and Extremity Numbness and Tingling. Vomited shortly after this. Slowly recovering, now experiencing a headache in addition to lingering fatigue and joint pain, despite taking another 1,000 mg of acetaminophen at 11:45 PM.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Nausea, Paraesthesia, Sleep disorder, Vomiting
Clinical narrative: Began to experience fatigue and joint pain/aching around 5:00 PM, which worsened as time progressed. Took 1,000 mg of acetaminophen at 6:00 PM. Attempted to sleep around 9:00 PM, but the pain and fatigue was still too much. At approximately 9:30 PM, fatigue and joint pain suddenly increased.  Began to experience the beginning stages of a fainting episode: Dizziness, Light-headedness, Perspiration, Nausea, and Extremity Numbness and Tingling. Vomited shortly after this. Slowly recovering, now experiencing a headache in addition to lingering fatigue and joint pain, despite taking another 1,000 mg of acetaminophen at 11:45 PM.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoacusis, Tinnitus
Clinical narrative: Ringing in left ear with decreased hearing.  Feels like pulsating in ear intermittently. Other times it?s just ringing or whirling sensation.   Have not seen provider yet for symptoms/adverse reaction.