chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Breast milk discolouration, Chills, Fatigue, Headache, Injection site pain
Clinical narrative: Beginning roughly 12 hours after vaccination,  I had a very sore injection site, which lasted an additional 32 hours. Also about 12 hours after injection, I experienced a low grade fever, shaking and chills, entire body soreness/achiness, fatigue, and a headache.  These symptoms lasted appx 24 hours, with the fever, shaking and chills dissipating around 20 hours and the remaining symptoms gone after 24-30 hours.  Additionally,  I am lactating and noticed a dramatic color change in my expressed milk roughly 17 hours after injection (normally a creamy yellow, 17 hours post-vaccination it appeared much more translucent and blue-tinted).
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Tremor
Clinical narrative: Beginning roughly 12 hours after vaccination,  I had a very sore injection site, which lasted an additional 32 hours. Also about 12 hours after injection, I experienced a low grade fever, shaking and chills, entire body soreness/achiness, fatigue, and a headache.  These symptoms lasted appx 24 hours, with the fever, shaking and chills dissipating around 20 hours and the remaining symptoms gone after 24-30 hours.  Additionally,  I am lactating and noticed a dramatic color change in my expressed milk roughly 17 hours after injection (normally a creamy yellow, 17 hours post-vaccination it appeared much more translucent and blue-tinted).
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: enlarged painful lymph node beginning 5 days after vaccine and persisting > 3weeks
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Skin warm, Swelling
Clinical narrative: Started a week after injection as egg-shape and size, swelling, red, hot, itching. Progressed to larger area each day but more like a red oval ring - larger and larger in diameter but less swollen, still hot and itchy. Today circles entire upper arm, more red on the perimeter. Took antihistamine last two days and less itchy
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Hot flush, Lethargy
Clinical narrative: Fever, chills, skin painful to touch, body pain, nausea, headache, lethargy. Hot flashes, nausea, fatigue and headache continuing 72 hours after shot.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Pain of skin, Pyrexia
Clinical narrative: Fever, chills, skin painful to touch, body pain, nausea, headache, lethargy. Hot flashes, nausea, fatigue and headache continuing 72 hours after shot.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Migraine, Nausea
Clinical narrative: Fever, chills, migraine, vomiting, nausea, dizziness, fatigue
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: Fever, chills, migraine, vomiting, nausea, dizziness, fatigue
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Injection site pain
Clinical narrative: Fatigue, soreness around shot area
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Lethargy, Musculoskeletal stiffness
Clinical narrative: Chills, headache, stiff neck, lethergy
Age: 90.0
Sex: M
Vaccine: COVID19
Symptoms: Death, Injection site pain
Clinical narrative: caller (son) stayed w/ the pt for about an hour after he received the vax and the pt stated the only symptoms at that time  was some achiness on the arm around the injection site.  Son went home after that.  He tried to contact him on 3/1/2021 but wasn't able to reach him.  On 3/2/21 the brother tried to contact him and wasn't able to reach him.  They contacted the police dept on 3/2/2021 around 8:00 AM to do a well check.  Pt was found on the couch like he had fallen asleep but was deceased.  They suspect he probably expired on 3/1/2021.  No autopsy will be conducted per the son.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth, Pruritus, Skin reaction
Clinical narrative: About 24 hours after first dose, patient reports that both her knees were red and itchy. The next day, the knees were normal. Also, patient reported that 9 days after first dose, the injection site on her arm had become itchy, red and warm.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Lethargy, Myalgia, Pyrexia
Clinical narrative: Muscle aches, joint pain, headache, and low-grade fever.  Also, lethargy. These symptoms lasted 24 to 30 hours.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Pfizer covis vaccine was mixed with 0.8 ml of saline instead of 1.8ml
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram abnormal, Nausea, Pallor
Clinical narrative: 0925 patient in general observation, ambulated to nurse stating she felt funny. Color pale, ambulated to private observation area. States she feels nauseated. Sat in chair and given emesis bag.  HR 157; O2 99%: BP 138/72. HR ausculated and rate confirmed. State she has no history of tachycardia or rapid heart beat. Denies "feeling" heart race. Denies itching, shortness of breath or difficulty swallowing. States she took her lisinopril and anxiety meds this morning. States she ate breakfast and performed her self catherization.  0940 Offered EMS transport/evaluation. Patient declined.  0942  patient states nausea resolved, BP 140/82; HR 136: O2 99% remains on rooms air.  0945 Auscultated Heart Rate at 140, strong/regular. Bilateral breath sounds clear to ausculation. Patient sitting in chair at rest. Color remains pink. Denies chest pain.  0948 Mother called patient's physician and reported to physician. PCP to return call to patient 0952 Patient to restroom, mom accompanied.  0955 Upon return from restroom, HR 160; O2 99% r/a, Denies feeling clammy, or having chest pain. denies hx of sinus tachycardia. Re-offered EMS eval due to elevated HR. Patient agreed to EMS eval.  0957 EMS activated 1013 Patient sitting in chair wringing hands. states she has excessive sweat glands and normally is very diaphoretic, states she feels dry at the moment. HR 144; O2 99% 1015 EMS and FD arrived.  1017 BP 103/61; HR 138; O2 99% and per EKG in ST per EMS monitors 1019 EMS recommended transport. Patient agreed.  1020 Transported via stretcher to ambulance to  Hospital ED.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary mass
Clinical narrative: Cyst on collar bone and armpit
Age: 1.0
Sex: U
Vaccine: HEPA, MMR
Symptoms: Product storage error
Clinical narrative: no additional AE reported; Vaqta involved in temperature excursion on 01/01/2021. Vaccine had been administered to 33 patients; This spontaneous report was received from a medical assistant and refers to a 12-month-old patient of unknown gender. The patient's pertinent medical history, drug reactions and concomitant therapies were not provided.   On 16-JAN-2021, the patient was vaccinated with improperly stored doses of hepatitis A vaccine, inactivated (VAQTA) lot # T013204 has been verified to be a valid lot number, with expiration date reported as 03-DEC-2021 and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (albumin status: recombinant Human albumin (rHA)) (M-M-R II) lot # S037500 has been verified to be a valid lot number, with expiration date reported as 20-NOV-2021 (strengths, exact doses, doses #, anatomical locations and routes of administration were not reported) as prophylaxis. Administered doses of vaccines experienced a temperature excursion of 47.01 degrees Fahrenheit for 1 minute and 30 seconds on 01-JAN-2021. Digital data logger was involved. There was no previous excursion noted. There was no additional adverse event reported.  This is one of 33 reports from the same reporter (original cases # 2102USA004059 and 2102USA003923). combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp; devicelotnumber: T013204; expirationdate: 03-DEC-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2102USA003923: US-009507513-2102USA004059:
Age: 1.0
Sex: U
Vaccine: HEPA, MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional AE reported; Vaqta involved in temperature excursion on 01/01/2021. Vaccine had been administered to 33 patients; This spontaneous report was received from a medical assistant and refers to a 12-month-old patient of unknown gender. The patient's pertinent medical history, drug reactions and concomitant therapies were not provided.   On 27-JAN-2021, the patient was vaccinated with improperly stored doses of hepatitis A vaccine, inactivated (VAQTA) lot # T013204 has been verified to be a valid lot number, with expiration date reported as 03-DEC-2021 and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (albumin status: recombinant Human albumin (rHA)) (M-M-R II) lot # S037500 has been verified to be a valid lot number, with expiration date reported as 20-NOV-2021 (strengths, exact doses, doses #, anatomical locations and routes of administration were not reported) as prophylaxis. Administered doses of vaccines experienced a temperature excursion of 47.01 degrees Fahrenheit for 1 minute and 30 seconds on 01-JAN-2021. Digital data logger was involved. There was no previous excursion noted. There was no additional adverse event reported.  This is one of 33 reports from the same reporter (original cases # 2102USA004059 and 2102USA003923). combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T013204; expirationdate: 03-DEC-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2102USA003923: US-009507513-2102USA004059:
Age: 1.0
Sex: U
Vaccine: HEPA, MMR
Symptoms: Product storage error
Clinical narrative: no additional AE reported; Vaqta involved in temperature excursion on 01/01/2021. Vaccine had been administered to 33 patients; This spontaneous report was received from a medical assistant and refers to a 12-month-old patient of unknown gender. The patient's pertinent medical history, drug reactions and concomitant therapies were not provided.   On 16-JAN-2021, the patient was vaccinated with improperly stored doses of hepatitis A vaccine, inactivated (VAQTA) lot # T013204 has been verified to be a valid lot number, with expiration date reported as 03-DEC-2021 and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (albumin status: recombinant Human albumin (rHA)) (M-M-R II) lot # S037500 has been verified to be a valid lot number, with expiration date reported as 20-NOV-2021 (strengths, exact doses, doses #, anatomical locations and routes of administration were not reported) as prophylaxis. Administered doses of vaccines experienced a temperature excursion of 47.01 degrees Fahrenheit for 1 minute and 30 seconds on 01-JAN-2021. Digital data logger was involved. There was no previous excursion noted. There was no additional adverse event reported.  This is one of 33 reports from the same reporter (original cases # 2102USA004059 and 2102USA003923). combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T013204; expirationdate: 03-DEC-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2102USA003923: US-009507513-2102USA004059:
Age: 1.0
Sex: U
Vaccine: HEPA, MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional AE reported; Vaqta involved in temperature excursion on 01/01/2021. Vaccine had been administered to 33 patients; This spontaneous report was received from a medical assistant and refers to a 12-month-old patient of unknown gender. The patient's pertinent medical history, drug reactions and concomitant therapies were not provided.   On 20-JAN-2021, the patient was vaccinated with improperly stored doses of hepatitis A vaccine, inactivated (VAQTA) lot # T013204 has been verified to be a valid lot number, with expiration date reported as 03-DEC-2021 and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (albumin status: recombinant Human albumin (rHA)) (M-M-R II) lot # S037500 has been verified to be a valid lot number, with expiration date reported as 20-NOV-2021 (strengths, exact doses, doses #, anatomical locations and routes of administration were not reported) as prophylaxis. Administered doses of vaccines experienced a temperature excursion of 47.01 degrees Fahrenheit for 1 minute and 30 seconds on 01-JAN-2021. Digital data logger was involved. There was no previous excursion noted. There was no additional adverse event reported.  This is one of 33 reports from the same reporter (original cases # 2102USA004059 and 2102USA003923). combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ;devicelotnumber: T013204; expirationdate: 03-DEC-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2102USA003923: US-009507513-2102USA004059:
Age: 1.0
Sex: U
Vaccine: HEPA, MMR
Symptoms: Product storage error
Clinical narrative: no additional AE reported; Vaqta involved in temperature excursion on 01/01/2021. Vaccine had been administered to 33 patients; This spontaneous report was received from a medical assistant and refers to a 12-month-old patient of unknown gender. The patient's pertinent medical history, drug reactions and concomitant therapies were not provided.   On 21-JAN-2021, the patient was vaccinated with improperly stored doses of hepatitis A vaccine, inactivated (VAQTA) lot # T013204 has been verified to be a valid lot number, with expiration date reported as 03-DEC-2021 and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (albumin status: recombinant Human albumin (rHA)) (M-M-R II) lot # S037500 has been verified to be a valid lot number, with expiration date reported as 20-NOV-2021 (strengths, exact doses, doses #, anatomical locations and routes of administration were not reported) as prophylaxis. Administered doses of vaccines experienced a temperature excursion of 47.01 degrees Fahrenheit for 1 minute and 30 seconds on 01-JAN-2021. Digital data logger was involved. There was no previous excursion noted. There was no additional adverse event reported.  This is one of 33 reports from the same reporter (original cases # 2102USA004059 and 2102USA003923). combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.  devicelotnumber: T013204; expirationdate: 03-DEC-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2102USA003923: US-009507513-2102USA004059:
Sex: U
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: improperly stored vaccines/Temperature (54.0F); This spontaneous report was received from an office manager and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 22-FEB-2021, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 2 ml, orally, lot # 1691300, expiration date 24-NOV-2021 (route of administration and anatomical location were not reported) for prophylaxis. Administered dose of vaccine was stored in the temperature of 54 degrees Fahrenheit (F) for 43 hours.  There were no previous temperature excursions reported. The improper storage was recorded by digital data logger.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Erythema, Fatigue, Pain, Pain in extremity
Clinical narrative: Pain; Redness; Sore arm; Fever; Tiredness; was in bed for 2 days with shivering; This case was reported by a consumer via call center representative and described the occurrence of pain in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd October 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced pain, erythema, pain in arm, shivering, fever and tiredness. On an unknown date, the outcome of the pain, erythema, pain in arm, shivering, fever and tiredness were recovered/resolved.   It was unknown if the reporter considered the pain, erythema, pain in arm, shivering, fever and tiredness to be related to Shingrix.  Additional details were provided as follows: The patient reported for herself. The patient received the vaccine in her left arm.  The patient reported that she had the common side effects that she read in article for about 2 to 3 days.  The patient experienced tiredness, fever, sore arm, redness, pain and was in bed for 2 days with shivering  Lot and expiration date were not requested. The reporter did not consent to follow-up.  The patient stated in her medical facility that they do not have a primary physician.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Pain; Redness; Sore arm; Fever; Tiredness; was in bed for 2 days with shivering; This case was reported by a consumer via call center representative and described the occurrence of pain in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd October 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced pain, erythema, pain in arm, shivering, fever and tiredness. On an unknown date, the outcome of the pain, erythema, pain in arm, shivering, fever and tiredness were recovered/resolved.   It was unknown if the reporter considered the pain, erythema, pain in arm, shivering, fever and tiredness to be related to Shingrix.  Additional details were provided as follows: The patient reported for herself. The patient received the vaccine in her left arm.  The patient reported that she had the common side effects that she read in article for about 2 to 3 days.  The patient experienced tiredness, fever, sore arm, redness, pain and was in bed for 2 days with shivering  Lot and expiration date were not requested. The reporter did not consent to follow-up.  The patient stated in her medical facility that they do not have a primary physician.
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Dizziness, Headache, Vertigo
Clinical narrative: stroke; vertigo attack; severe headaches; severe dizziness; A spontaneous report was received from a consumer who was also a male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and who experienced severe headaches / headache, severe dizziness / dizziness, vertigo attack / vertigo, and stroke / cerebrovascular accident.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 13 Feb 2021, prior to the onset of the events, the patient received their second dose of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.  On 13 Feb 2021, about 12 hours after receiving the vaccine, the patient experienced severe dizziness and severe headaches which lasted for about 4 days.   On 17 Feb 2021, while driving, the patient thought he was having a vertigo attack and went to the emergency room. He had a cat scan (results not provided) and was treated with TPA (tissue plasminogen activator). After three days in the hospital, they determined he had a stroke.  Action taken with mRNA-1273 in response to the events was not applicable.   The outcome of the events, severe headaches, severe dizziness, vertigo attack, and stroke, was not provided.; Reporter's Comments: This case concerns a male patient, who experienced a serious unexpected event of cerebrovascular accident among others, 5 days after receiving 2nd dose of mRNA- 1273 (Lot# unknown). Very limited information regarding this event has been provided at this time. Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure decreased, Blood pressure measurement, Nephrolithiasis, Sepsis, Stent placement
Clinical narrative: sepsis; surgery to put stent in; Blood pressure dropped to 70/20; kidney stone; A spontaneous report was received from a consumer who is an 80-years-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and who experienced sepsis, kidney stone, stent replacement and ended up in ICU and blood pressure dropped to 70/20.    The patient's medical history included 6 months of chemo and cataracts surgery in both eyes (not specified).   The concomitant product was not provided .   On an unknown date prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: Unknown) in the right arm and patients second dose was scheduled on 25-Feb-2021 for prophylaxis of COVID-19 infection.  On an unknown date, after vaccination patient experienced sepsis, put the stent in and ended up in ICU and blood pressure dropped to 70/20/ blood pressure low (18-Jan-2021) and kidney stone.  The patient was hospitalized for sepsis,  stent replacement and ended up in ICU and blood pressure dropped to 70/20/ blood pressure low.  On 04-Mar-2021, she was going to have surgery to have kidney stone which was 9cm long removed and to have stent replaced.  Treatment information was not provided.  Action taken with respect to  mRNA-1273 in response to the events.  The outcome of the events was not reported for all events.; Reporter's Comments: Very limited information regarding these events has been provided at this time.  Further information has been requested. However, the events of kidney stone and stent replacement are unlikely because the kidney stone was preexisting  and the procedure of stent replacement was planned for a later date.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Fatigue, Myalgia
Clinical narrative: Knees were on fire inside, tight, stiff, and can't bend them; Aches; Fatigue; A a spontaneous case report was received from a 68 year old female Other Health Professional concerning herself who received second dose of Moderna COVID-19 Vaccine (m-Rna-1273)..  The patients past medical history included double mastectomy and was a cancer survivor. Once the patient took a cancer pill and it made her knees feel like they were on fire. This was 6 years ago. Ongoing conditions of the patient included arthritis and blood pressure. Concomitant medications of the patient included meloxicam, multi vit , atenolol, losartan potassium ,hydrochloroth (hydrochlorothiazide) and potassium chloride.  On 15 Jan 2021  the patient started taking Moderna COVID-19 Vaccine for COVID-19 vaccination. The patient took the second dose of vaccine on 12 Feb 2021 into left arm intramuscularly. Five  days later on 17 Feb 2021,  the patient developed Knee arthritis. The patient also developed aches and fatigue. It hit in the knees and she could barely walk. She had o sit down from room to room.  The patient reported the serious criteria to be temporary disability. Patient reported her arm was still black and blue from the first shot when she went for the second one. She had to get both the doses in left arm due to double mastectomy.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was unknown.  Outcome of the events fatigue and aches was unknown and that of Knees were on fire inside, tight, stiff, and can't bend them was not recovered not resolved.  The reporter causality for the events was not provided.; Reporter's Comments: Very limited information regarding this events has been provided at this time.  Further information has been requested.
Sex: U
Vaccine: FLU4, FLUR4, TYP
Symptoms: Product temperature excursion issue
Clinical narrative: Admelog vials, lantus Vials, Lantus solstar, Toujeo, Flublok, Fluzone QD PFS, Typhim Vi and Apidra vials exposed at 46-53.5 deg F for 13 hours. Excursion happened when refrigerator door was not closed fully with no AE; Potential PTC:No Description:Rph wanted to gather stability information on Admelog vials, lantus Vials, Lantus solstar, Toujeo, Flublok, Fluzone QD PFS, Typhim Vi and Apidra vials exposed at 46-53.5 deg F for 13 hours. Excursion was happened when refrigerator door was not closed fully. Caller refused to provide the Lot# of the products. Additional Description of event Adverse events :Rph wanted to gather stability information on Admelog vials, lantus Vials, Lantus solstar, Toujeo, Flublok, Fluzone QD PFS, Typhim Vi and Apidra vials exposed at 46-53.5 deg F for 13 hours. Excursion was happened when refrigerator door was not closed fully. Caller refused to provide the Lot# of the products. Clarification note: Kindly reassess and delete suspect drugs if not required at step as it was not clearly mentioned if patients was using the reported drugs. Update outcome as not applicable.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling hot, Injection site erythema, Injection site swelling, Paraesthesia oral
Clinical narrative: Patient received vaccine at 10:39am and was in the observation area. At about 3 minutes (10:42 am) she began to feel  " a tingly sensation in my tongue"  and felt warm. She also had localized redness and swelling at the site of injection (Right deltoid). She denied any symptoms of chest pain, SOB, palpitations, difficulty swallowing, drooling,  nausea/vomiting, dizziness or light-headed or near syncope. Patient was observed by provider for a course of one hour. We recommended to be taken by EMS to ER for further observation, she refused. Patient drove herself and was not able to take Benadryl.  Initial vital signs taken 10:54am 177/114; HR 92; O2 98% RA; RR 18 -sitting position Second vitals 11:35am 134/96; HR 79; O2 100% RA ; RR 16- sitting position Patient was observed for an hour and decided to drive home. Recommend hydration and call 911 if needed.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Swollen tongue, Tongue pruritus
Clinical narrative: Patient received vaccine at 10:39am and was in the observation area. At about 3 minutes (10:42 am) she began to feel  " a tingly sensation in my tongue"  and felt warm. She also had localized redness and swelling at the site of injection (Right deltoid). She denied any symptoms of chest pain, SOB, palpitations, difficulty swallowing, drooling,  nausea/vomiting, dizziness or light-headed or near syncope. Patient was observed by provider for a course of one hour. We recommended to be taken by EMS to ER for further observation, she refused. Patient drove herself and was not able to take Benadryl.  Initial vital signs taken 10:54am 177/114; HR 92; O2 98% RA; RR 18 -sitting position Second vitals 11:35am 134/96; HR 79; O2 100% RA ; RR 16- sitting position Patient was observed for an hour and decided to drive home. Recommend hydration and call 911 if needed.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Hypersensitivity, Incomplete course of vaccination, Influenza like illness, Muscle tightness
Clinical narrative: Typical flu-like symtoms the next day *For me- Increased myofascial tightness of muscles; also *A rash over my entire trunk (like sandpaper/red bumps) * An inflammatory rash on my chest
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Myofascial pain syndrome, Rash, Rash erythematous
Clinical narrative: Typical flu-like symtoms the next day *For me- Increased myofascial tightness of muscles; also *A rash over my entire trunk (like sandpaper/red bumps) * An inflammatory rash on my chest
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Nausea, Pyrexia
Clinical narrative: Fever for 18 hours (100.4), chills, nausea, vomiting, severe headache, and exhaustion.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Fever for 18 hours (100.4), chills, nausea, vomiting, severe headache, and exhaustion.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Hypoaesthesia oral, Pharyngeal swelling, Swollen tongue
Clinical narrative: tongue felt numb, and then started to swell as well as throat.  Felt very weird swallowing.  Pharmacist gave me benedryl and made me stay there longer.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain in extremity, Peripheral swelling
Clinical narrative: First dose in left arm with significant pain and swelling in left axillary lymph node 6 days after vaccine. This still hurts 6 weeks later.  Second dose I chose to have it in my other arm since first arm still hurt.  Same problem. Lymph node swelling in right axillary lymph node the next day.  Problem: This side effect has not been widely communicated. I did not know that this was a side effect and did not connect it to the vaccine the first time because it happened 6 days after my vaccination date. So, this caused me to go to two doctors. The first doctor was online and did not know the problem but suspected that I could have a DVT. She did not know that this was a side effect. So, she sent me to an in person doctor who recognized that it was a vaccine side effect. Please add this side effect to your publicity to save others from having an unnecessary doctor's visit.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Feeling abnormal, Headache, Pyrexia
Clinical narrative: Brain Fog like after waking from Anesthesia. lasted several hours. was gone by about 1:30 PM Feb 27 2021. checked oxygen level it was 95% like usual. other Side effects were usual Headache, Joint Pain, Chills, Fever of 100.7 degrees, stomach cramps.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site urticaria
Clinical narrative: About nine days after receiving my first dose of the vaccine, I took a shower and noticed a HUGE red hive or rash on my left arm at the injection site. The rash is not itchy or painful, but is worrisome based on how quickly it went from being ok to bright red and visible.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Erythema, Fatigue, Injection site pain, Pain
Clinical narrative: Low grade fever, chills, fatigue, body aches, sore red growing area swollen arm.  (redness is an area of 5"x3")
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: Low grade fever, chills, fatigue, body aches, sore red growing area swollen arm.  (redness is an area of 5"x3")
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site bruising, Injection site induration, Injection site mass, Injection site pain, Injection site warmth
Clinical narrative: On March 2nd and 3rd I had a very sore, feverish, harden lump at the site of injection. I even checked the temp with my infrared thermometer and I was at 97.6 while the spot was over 100.4. It sometimes felt like someone was putting a stick into my arm,, sometimes it was throbbing but it was very sore and feverish the whole 2 days.  It was about a 10 cm circular area (my husband took pictures) I left it alone hoping it would get better. It has pretty much gone away now although it is still warm and feels like an old bruise.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Pyrexia
Clinical narrative: On March 2nd and 3rd I had a very sore, feverish, harden lump at the site of injection. I even checked the temp with my infrared thermometer and I was at 97.6 while the spot was over 100.4. It sometimes felt like someone was putting a stick into my arm,, sometimes it was throbbing but it was very sore and feverish the whole 2 days.  It was about a 10 cm circular area (my husband took pictures) I left it alone hoping it would get better. It has pretty much gone away now although it is still warm and feels like an old bruise.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash, Injection site swelling, Pruritus
Clinical narrative: Rash and bump at area of injection site.  Itchy.  Resolved in 2 days.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Days 1-3 after injection intense soreness at injection site and full shoulder muscle. Day 6 - extreme headache all day ( don?t know if it?s relayed but not usual for me) Day 7- round, hard, red, and itchy spot appear at injection site
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus
Clinical narrative: Days 1-3 after injection intense soreness at injection site and full shoulder muscle. Day 6 - extreme headache all day ( don?t know if it?s relayed but not usual for me) Day 7- round, hard, red, and itchy spot appear at injection site
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Dizziness, Erythema, Fatigue
Clinical narrative: Patient states woke up at 4 AM 2/23/21, felt ill and weak, went to wake up husband, "went black" and then blacked out woke up laying on floor, couldn't move arms or legs, not sure if hit head,  laid on floor close to 1 hour, difficulty getting back into bed, extreme nausea, dry heaves, weak, headache, dizzy, chills, dizzy x 1 week, dizzy 3/3/21, got into bed 6:30 PM,  face flushed and reddened, called daughter who is nurse, daughter checked temperature and blood pressure, no fever, B/P 156/102 (normally  120/82), B/P came down to when retaken to 140/90), was "upset" at time of first B/P reading, causing elevation. Continues to have weakness and fatigue, headache comes and goes.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Headache, Malaise, Mobility decreased, Nausea
Clinical narrative: Patient states woke up at 4 AM 2/23/21, felt ill and weak, went to wake up husband, "went black" and then blacked out woke up laying on floor, couldn't move arms or legs, not sure if hit head,  laid on floor close to 1 hour, difficulty getting back into bed, extreme nausea, dry heaves, weak, headache, dizzy, chills, dizzy x 1 week, dizzy 3/3/21, got into bed 6:30 PM,  face flushed and reddened, called daughter who is nurse, daughter checked temperature and blood pressure, no fever, B/P 156/102 (normally  120/82), B/P came down to when retaken to 140/90), was "upset" at time of first B/P reading, causing elevation. Continues to have weakness and fatigue, headache comes and goes.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Retching
Clinical narrative: Patient states woke up at 4 AM 2/23/21, felt ill and weak, went to wake up husband, "went black" and then blacked out woke up laying on floor, couldn't move arms or legs, not sure if hit head,  laid on floor close to 1 hour, difficulty getting back into bed, extreme nausea, dry heaves, weak, headache, dizzy, chills, dizzy x 1 week, dizzy 3/3/21, got into bed 6:30 PM,  face flushed and reddened, called daughter who is nurse, daughter checked temperature and blood pressure, no fever, B/P 156/102 (normally  120/82), B/P came down to when retaken to 140/90), was "upset" at time of first B/P reading, causing elevation. Continues to have weakness and fatigue, headache comes and goes.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Headache, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: A few hours after vaccination, I experienced noticeable sinus/nasal congestion.  The following morning, 12 hours post vaccination, I experienced sore arm,  headache and GI upset.  Those symptoms resolved completely  within 72 hours. On the morning of February 18, 2021 (8 days post vaccination), my arm become sore again at area of injection.  A  painful raised welt, about the size of half a tennis ball, developed.  About 12 hours later, the raised site became red and itchy.  The rash continued to spread over the next 24 hours to approximately 3.5? x 2.0?.  The site continued to improve daily and swelling, pain and itchiness  resolved in 5 days on February 23, 2021.  A very slight, flat, painless discoloration  was still detectable in a small area (approximately 0.5? x  1.0? until  February 26, 2021.  During this time, I used cold compress and topical Benedryl cream on the site 2x on February 19th and February 20th.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash, Injection site swelling, Nasal congestion, Pain in extremity, Sinus congestion
Clinical narrative: A few hours after vaccination, I experienced noticeable sinus/nasal congestion.  The following morning, 12 hours post vaccination, I experienced sore arm,  headache and GI upset.  Those symptoms resolved completely  within 72 hours. On the morning of February 18, 2021 (8 days post vaccination), my arm become sore again at area of injection.  A  painful raised welt, about the size of half a tennis ball, developed.  About 12 hours later, the raised site became red and itchy.  The rash continued to spread over the next 24 hours to approximately 3.5? x 2.0?.  The site continued to improve daily and swelling, pain and itchiness  resolved in 5 days on February 23, 2021.  A very slight, flat, painless discoloration  was still detectable in a small area (approximately 0.5? x  1.0? until  February 26, 2021.  During this time, I used cold compress and topical Benedryl cream on the site 2x on February 19th and February 20th.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Skin discolouration
Clinical narrative: A few hours after vaccination, I experienced noticeable sinus/nasal congestion.  The following morning, 12 hours post vaccination, I experienced sore arm,  headache and GI upset.  Those symptoms resolved completely  within 72 hours. On the morning of February 18, 2021 (8 days post vaccination), my arm become sore again at area of injection.  A  painful raised welt, about the size of half a tennis ball, developed.  About 12 hours later, the raised site became red and itchy.  The rash continued to spread over the next 24 hours to approximately 3.5? x 2.0?.  The site continued to improve daily and swelling, pain and itchiness  resolved in 5 days on February 23, 2021.  A very slight, flat, painless discoloration  was still detectable in a small area (approximately 0.5? x  1.0? until  February 26, 2021.  During this time, I used cold compress and topical Benedryl cream on the site 2x on February 19th and February 20th.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Pain, Pyrexia, Vomiting
Clinical narrative: tenderness at injection site, low grade fever, aching in all joints-started at 12:30-7;30 3/5/21, 3 doses of advil,vomiting
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Oral discomfort
Clinical narrative: Vaccine was administered at 2:05pm on 02/02/2021.  At 6:00pm EST my mouth felt odd as if I burned my palate.  After 48 hours the feeling did not subside so I made an appointment to visit my oral surgeon.  On 02/04/2021 I visited my oral surgeon who took  multiple pictutes of my mouth/palate and felt it was a reaction to the vaccine.  She prescribed a mouthwash as treatment and a follow up in 2 weeks.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Erythema, Hot flush
Clinical narrative: face became hot & red, felt dizzy/light headed, went away after about an hour
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Myalgia
Clinical narrative: Muscle and joint aches, chills, exhaustion, head aches.  Note  - the lots numbers on the 1st and 2nd dose given 4 weeks apart at separate facilities are the same.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: About 6 days I developed a rash by injection site that was itchy, red and little swollen and felt warmer to the touch. It is about 3 inches long by 2 inches wide. Currently only affecting the injection site area. On day 2 of reaction, symptoms are improving: mild itching and redness. Less swelling
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Muscular weakness, Urticaria
Clinical narrative: Patient stated he started having hives, diarrhea and chills 2 days after the vaccine. At the current time, 2 weeks later, he is still having the same adverse events and now has leg weakness.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Dyspepsia
Clinical narrative: The night of the day I got the second dose of the Pfizer COVID vaccine, I felt like my stomach was on fire. I also felt really bloated. It felt like someone placed a sphere in my abdomen and then set it on fire. I tried eating, drinking water, and sleeping and nothing has helped. I have felt like this since then and it is currently 3/5 and I got the vaccine on 3/3.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Cough, Dizziness, Headache
Clinical narrative: the adverse event started on 2/12 around 5pm and i got cold down to the bone and it lasted and I never got warm all night. 2/13 my arm was sore and slightly swollen arm was warm and i got really tired, then the headaches started went across the head and got worse and worse. on 2/14 - 2/28 I had diarrhea headache and bone chills, loss of taste and smell,  2/16 dizzy, sore throat, runny nose, cough and fever, 24th brain fog started, 25 vomiting started, on 3/1 I had just headaches, I'm still tired but I can stay away today
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis, Oropharyngeal pain, Peripheral swelling, Pyrexia, Rhinorrhoea
Clinical narrative: the adverse event started on 2/12 around 5pm and i got cold down to the bone and it lasted and I never got warm all night. 2/13 my arm was sore and slightly swollen arm was warm and i got really tired, then the headaches started went across the head and got worse and worse. on 2/14 - 2/28 I had diarrhea headache and bone chills, loss of taste and smell,  2/16 dizzy, sore throat, runny nose, cough and fever, 24th brain fog started, 25 vomiting started, on 3/1 I had just headaches, I'm still tired but I can stay away today
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: the adverse event started on 2/12 around 5pm and i got cold down to the bone and it lasted and I never got warm all night. 2/13 my arm was sore and slightly swollen arm was warm and i got really tired, then the headaches started went across the head and got worse and worse. on 2/14 - 2/28 I had diarrhea headache and bone chills, loss of taste and smell,  2/16 dizzy, sore throat, runny nose, cough and fever, 24th brain fog started, 25 vomiting started, on 3/1 I had just headaches, I'm still tired but I can stay away today
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hypoaesthesia, Hypoaesthesia oral, Injection site pain, Myalgia
Clinical narrative: I received my first dose of the Pfizer COVID-19 Vaccine on 3/2/2021 in my left arm. After approx. 30 minutes of receiving my shot my left side of my face felt numb including the left side of my tounge as well as muscle pain and soreness on the left side on the back of my neck. Today is 3/5/2021, my face is slowly becoming less numb over time and rest. I also experienced fatigue and injection site soreness. I am particularly concerned about my face becoming numb shortly after receiving my vaccine and I am wondering if I should get a second dose when I need to?
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain
Clinical narrative: I received my first dose of the Pfizer COVID-19 Vaccine on 3/2/2021 in my left arm. After approx. 30 minutes of receiving my shot my left side of my face felt numb including the left side of my tounge as well as muscle pain and soreness on the left side on the back of my neck. Today is 3/5/2021, my face is slowly becoming less numb over time and rest. I also experienced fatigue and injection site soreness. I am particularly concerned about my face becoming numb shortly after receiving my vaccine and I am wondering if I should get a second dose when I need to?
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Taste disorder
Clinical narrative: 2 hours after the vaccine I experienced the sudden onset of a strong metallic taste on my tongue. This taste lessened on a daily basis and finally disappeared after 5 days.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Pain in extremity
Clinical narrative: Swelling in arm around injection site, pain in arm from shoulder to fingers
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Death, Fall, Feeling abnormal, Head injury, Muscular weakness
Clinical narrative: at midnight client got up to go to the bathroom. His legs became weak and he fell and hit his head on the wall. He called for his wife and said he didn't feel right. He denied any pain. She called EMSA and he stopped breathing while she was waiting on them. She gave him CPR with instructions from the dispatcher. He was pronounced dead at 1:30am. She has tried to call the clinic 3 times and left messages and no one has called her back, Her PCP told her this needed to be reported .
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Respiratory arrest, Resuscitation
Clinical narrative: at midnight client got up to go to the bathroom. His legs became weak and he fell and hit his head on the wall. He called for his wife and said he didn't feel right. He denied any pain. She called EMSA and he stopped breathing while she was waiting on them. She gave him CPR with instructions from the dispatcher. He was pronounced dead at 1:30am. She has tried to call the clinic 3 times and left messages and no one has called her back, Her PCP told her this needed to be reported .
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Decreased appetite, Fatigue, Headache, Hypersomnia
Clinical narrative: Fever spiking to 102.6, headache, confusion, loss of appetite, nausea, extreme tiredness(slept for almost 24 hours straight).  I took Tylenol for the fever, which did not really work until 3/4/2021.  Fever finally broke to just under 100 by 3/4/2021 and was gone completely by 3/5/2021. Headache was gone by 3/4/2021.  All other symptoms have subsided by 3/5/2021.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia
Clinical narrative: Fever spiking to 102.6, headache, confusion, loss of appetite, nausea, extreme tiredness(slept for almost 24 hours straight).  I took Tylenol for the fever, which did not really work until 3/4/2021.  Fever finally broke to just under 100 by 3/4/2021 and was gone completely by 3/5/2021. Headache was gone by 3/4/2021.  All other symptoms have subsided by 3/5/2021.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash erythematous, Rash papular, Rash pruritic, Skin burning sensation
Clinical narrative: Recived vaccine on Saturday, February 27, 2021, at 4:15 PM.  No adverse events at that time.  On Thursday, March 4, 2021, at 9:00 PM, I noticed on both inner arms a red, raised rash.  It was burning, painful and itching.  Can not touch or wear long sleeves. Notified PCP but office has not responded yet.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Contusion, Injection site haemorrhage, Pain in extremity, Rash
Clinical narrative: Pain in left arm . Swelling . Rash that is warm to the touch. Sore left shoulder .  Lasting over 2 weeks . Bruise that is still visible after 17 days . (Bleeding at the time of shot. )
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Skin warm, Swelling
Clinical narrative: Pain in left arm . Swelling . Rash that is warm to the touch. Sore left shoulder .  Lasting over 2 weeks . Bruise that is still visible after 17 days . (Bleeding at the time of shot. )