chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Body temperature, Chills, Condition aggravated, Diarrhoea
Clinical narrative: diarrhea; lethargic; fever of 102; shivering; weak; This case was reported by a consumer via call center representative and described the occurrence of diarrhea in a 60-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 6th February 2021, the patient received the 2nd dose of Shingrix .5 ml. On 7th February 2021, 1 days after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced diarrhea, lethargy, fever, shivering and weakness. On an unknown date, the outcome of the diarrhea, lethargy, fever, shivering and weakness were not recovered/not resolved.   The reporter considered the diarrhea, lethargy, fever, shivering and weakness to be related to Shingrix.  Additional information was provided as follows: The patient received vaccine in left arm. The patient received 1st dose 2 month before reporting, the patient did not remember if he experienced any side effects after his first dose. The patient woke up a day before reporting, experienced shivering and a fever of 102 Degree F.  The patient was also lethargic and weak and experiencing some diarrhea.  All symptoms improved till the time of reporting except for the diarrhea which had worsened. The reporter did not consent to follow up.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Lethargy, Pyrexia
Clinical narrative: diarrhea; lethargic; fever of 102; shivering; weak; This case was reported by a consumer via call center representative and described the occurrence of diarrhea in a 60-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 6th February 2021, the patient received the 2nd dose of Shingrix .5 ml. On 7th February 2021, 1 days after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced diarrhea, lethargy, fever, shivering and weakness. On an unknown date, the outcome of the diarrhea, lethargy, fever, shivering and weakness were not recovered/not resolved.   The reporter considered the diarrhea, lethargy, fever, shivering and weakness to be related to Shingrix.  Additional information was provided as follows: The patient received vaccine in left arm. The patient received 1st dose 2 month before reporting, the patient did not remember if he experienced any side effects after his first dose. The patient woke up a day before reporting, experienced shivering and a fever of 102 Degree F.  The patient was also lethargic and weak and experiencing some diarrhea.  All symptoms improved till the time of reporting except for the diarrhea which had worsened. The reporter did not consent to follow up.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity
Clinical narrative: arm has been hurting / when she moves it, it hurts; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In September 2020, the patient received the 1st dose of Shingrix. On an unknown date, immediately after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional information was provided as follows: Since the patient got the vaccine, her arm has been hurting. She stated that if she did not move her arm, its fine, but when she move it, it hurts and has done so for 5 months. The patient did not want to get the second dose of shingrix. She did not want to provide HCP (Health Care Professional) information until she went to an appointment The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: First dose on 09Dec2020 and 4 weeks later contracted Zoster; This case was reported by a other health professional via call center representative and described the occurrence of shingles in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th December 2020, the patient received the 1st dose of Shingrix. On 30th December 2020, 21 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The reporter called for information regarding the second dose of the Shingrix vaccine. The patient received first dose and 4 weeks later contracted zoster. No other information was reported.
Age: 17.0
Sex: U
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 17 year old patient received Moderna vaccine; A spontaneous report was received from a nurse concerning a 17 years-old patient (demographics not provided) who received Moderna's COVID-19 vaccine (mRNA-1273).  The patient's medical history was not provided. Concomitant product use was not provided by reporter.    On 16 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (lot #: 013M20A) (site of administration not specified), intramuscularly for prophylaxis of COVID-19 infection.  On 16 Feb 2021, the 17 years-old patient was administered Moderna vaccine. The nurse was inquiring what to do next. Treatment information was not provided.   Action taken with mRNA-1273 in response to the events was not reported.  On 16 Feb 2021, the event 17 year old patient received Moderna vaccine was considered resolved.; Reporter's Comments: This report refers to a case of 17- year-old patient who received for mRNA-1273, lot # 013M20A (Inappropriate age at vaccine administration) . There were no reported AEs associated with this case of Inappropriate age at vaccine administration.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Headache, Inappropriate schedule of product administration, Tinnitus
Clinical narrative: within a minute of each other the nurse gave 2 full doses of vaccine; hard time breathing; lightheadedness; tinnitus, ringing in ears; redness on left arm; headache; A spontaneous report was received from a relative concerning a 72-year old, female patient who received both Moderna's COVID-19 vaccine (mRNA-1273) doses within a minute of each other and experienced having a hard time breathing, headache, redness on left arm, lightheadedness, and tinnitus- ringing in ears.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 14 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Batch number: 011M20A) intramuscularly for prophylaxis of COVID-19 infection. Within one minute, the nurse gave her the second dose of mRNA-1273 (Batch number not provided). The patient had a hard time breathing, bad headache, large redness on left arm, lightheadedness, and tinnitus (ringing in ears). The patient took ibuprofen (400 mg) on 14 Feb 2021 and 15 Feb 2021. On 16 Feb 2021, the patient took Advil (200 mg).   The patient received both scheduled doses of mRNA-1273; therefore, action taken with the drug in response to the event is not applicable.  The outcome of the event, within a minute of each other the nurse gave 2 full doses of vaccine, was considered resolved on 14 Feb 2021. The outcomes of the events: hard time breathing, redness on left arm, lightheadedness, tinnitus-ringing in ears, and headache is unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: within a minute of each other the nurse gave 2 full doses of vaccine; hard time breathing; lightheadedness; tinnitus, ringing in ears; redness on left arm; headache; A spontaneous report was received from a relative concerning a 72-year old, female patient who received both Moderna's COVID-19 vaccine (mRNA-1273) doses within a minute of each other and experienced having a hard time breathing, headache, redness on left arm, lightheadedness, and tinnitus- ringing in ears.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 14 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Batch number: 011M20A) intramuscularly for prophylaxis of COVID-19 infection. Within one minute, the nurse gave her the second dose of mRNA-1273 (Batch number not provided). The patient had a hard time breathing, bad headache, large redness on left arm, lightheadedness, and tinnitus (ringing in ears). The patient took ibuprofen (400 mg) on 14 Feb 2021 and 15 Feb 2021. On 16 Feb 2021, the patient took Advil (200 mg).   The patient received both scheduled doses of mRNA-1273; therefore, action taken with the drug in response to the event is not applicable.  The outcome of the event, within a minute of each other the nurse gave 2 full doses of vaccine, was considered resolved on 14 Feb 2021. The outcomes of the events: hard time breathing, redness on left arm, lightheadedness, tinnitus-ringing in ears, and headache is unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: daughter who is under 18 received the vaccine; A spontaneous report received from a Consumer concerning, 17-year-old, female patient who received dose of Moderna COVID-19 vaccine.    The patient's medical history was not included. Patient's concomitant was not included.   On 19JAN2021, the patient received their 1st dose of the two planned doses of mRNA-1273 in unknown arm (Batch #: 025L20A) intramuscularly for prophylaxis of COVID-19 infection.   Patient father stated that his daughter who was under 18 received her 1st dost of the Moderna COVID-19 vaccine. Father stated when he took her back for the 2nd dose of the Moderna COVID-19 vaccine the facility denied her.   Treatment information was not included/ unknown.   Action taken with mRNA-1273 in response to the event was not provided.  The outcome of the event was considered as recovered.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age (17 year old) for mRNA-1273 (lot number 025L20A) with no associated AEs reported.
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered at inappropriate site, Tenderness, Vaccination site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Warm to the touch; Tender; Swollen; Red spot; A little off from deltoid muscle; A spontaneous report received from a consumer concerning, 90-year-old, female patient who received Moderna's COVID-19 vaccine a little off from the deltoid muscle and experienced redness, swelling, warm to the touch, and tenderness. PT: [Product administered at inappropriate site, injection site erythema, injection site swelling, injection site warmth, and tenderness].   The patient's medical history was not included. Patient's concomitant included calcium, vitamin D, levothyroxine sodium, atorvastatin, citalopram hydrochloride, amitriptyline, triamterene/hydrochlorothiazide, acetylsalicylic acid, and lorazepam.   On 02 FEB 2021, the patient received their 1st dose of the two planned doses of mRNA-1273 in left arm (Batch #: 007M20A) for prophylaxis of COVID-19 infection.   On 02 Feb 2021, the patient received the vaccine 'a little off from the deltoid muscle' as described by the patient's daughter (nurse). Approximately 9 days later, the patient developed a red spot on her arm and it was swollen and warm to the touch. At the time of the report, the patient's arm was still swollen. The redness was fading and her arm was tender. Treatment for this event included paracetamol.   Action taken with mRNA-1273 in response to the event was not provided/unknown.   The event, vaccine administered at inappropriate site, was considered recovered/resolved on 02 Feb 2021  The event, redness was considered recovering/resolving.   The events, swelling and tenderness, was considered not recovered/not resolved.  The outcome of the event, tenderness, was unknown/ not reported.; Reporter's Comments: This report refers to a case of product administered at inappropriate site for mRNA-1273, (lot # 007M20A) with associated injection site erythema, swelling, warmth, and tenderness. Based on the current available information and temporal association between the use of the product and the start date of the injection site events, a causal relationship cannot be excluded.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Device connection issue, Exposure via skin contact, Underdose
Clinical narrative: Dose leaked during administration of vaccine; did not receive the full dose of the vaccine; vaccine leaked down arm; A spontaneous report was received from a consumer concerning a 71 year old, female patient who experienced the syringe connection issue, vaccine underdose, and exposure via skin contact.   The patient's medical history was not provided.  Concomitant product use was not provided/unknown by the reporter.    On 14-FEB-2021, the patient received their first of two planned doses of mRNA-1273 (Batch number: 011M20A) intramuscularly in the arm for prophylaxis of COVID-19 infection.    While receiving the vaccine, the patient said the vaccine leaked down her arm and did not receive the full dose. Treatment information was not provided.   Action taken with mRNA-1273 in response to the event(s) was not provided.  The outcome of the events,syringe connection issue, vaccine underdose, and exposure via skin contact were recovered.; Reporter's Comments: This case concerns a 71-year-old female patient who received their first of two planned doses of mRNA-1273 (Lot 011M20A), reporting Underdose, device connection issue, and exposure via skin contact without any associated adverse events.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Inappropriate schedule of product administration
Clinical narrative: Missed second dose; COVID-19; A spontaneous report was received from a health care professional concerning a 59-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and was diagnosed with COVID-19, missed second dose. Crosslinked case is MOD21-031684.  The patient's medical history was not provided.  Relevant concomitant medications were reported i.e., methotrexate, Prozac, lamictal, Ritalin.  On 05Jan2021 prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273(lot/batch: 026L20A) intramuscularly in the left dominant arm for prophylaxis of COVID-19 infection.  Laboratory data was not provided.  Treatment details included steroids and  ibuprofen.   Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the event was reported that with help of steroids the patient felt better at the third week window.; Reporter's Comments: The event of COVID-19 was consistent with infection in pandemic set up.  Very limited information regarding these events has been provided at this time. The event of COVID-19 is assessed as not related to company product.
Age: 94.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Pt received 1st dose on 03FEB2021 and 2nd dose on 14FEB2021; A spontaneous report was received from a caregiver regarding a 94-year-old female patient who received Moderna's mRNA-1273 vaccine first dose on 03 February 2021 and second dose on 14 February 2021/Inappropriate schedule of vaccine administered.  The patient's medical history was not provided. Concomitant medications were not provided.   On 03 February 2021, the patient received the first of two planned doses of mRNA-1273 (Batch: unknown) for prophylaxis of COVID-19 infection.  On 14 February 2021, the patient received the second of two planned doses of mRNA-1273 (Batch: unknown) for prophylaxis of COVID-19 infection. This dose was administered earlier than guidelines recommend.   Treatment information was not provided.  Action taken with mRNA-1273 was not applicable.  The outcome of the event, receiving first dose on 03 February 2021, and the second dose on 14 February 2021, was considered resolved.; Reporter's Comments: This report refers to a case of inappropriate schedule of vaccine administered for mRNA-1273 (lot #unknown) with no associated AEs reported.
Sex: U
Vaccine: COVID19
Symptoms: Device connection issue, Underdose
Clinical narrative: faulty needle and syringe that caused leakage to occur; Not the entire quantity was injected into the patient; incomplete dose administered; A Spontaneous report was received from a pharmacist concerning a patient of unknown age and gender who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a faulty needle and syringe that caused leakage to occur and not the entire quantity was injected into the patient.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On an unknown date, the patient received a dose of two planned doses of mRNA-1273 (Lot number unknown) intramuscularly for prophylaxis of COVID-19 infection.  On an unspecified date, it was reported that a faulty needle and syringe caused leakage to occur and the patient did not receive the entire quantity of the vaccine. Treatment information was not provided.   Action taken with mRNA-1273 in response to the events was not reported.  The events of faulty needle and syringe that caused leakage to occur and not the entire quantity was injected into the patient was considered resolved on an unspecified date.; Reporter's Comments: This report refers to a case of a patient of unknown age and gender who experienced non-serious unexpected event of faulty needle and syringe that caused leakage to occur and not the entire quantity was injected into the patient (device connection issue, incomplete dose administered) for mRNA-1273, lot # unknown. There were no reported AEs associated with this case of device connection issue and incomplete dose administered
Sex: F
Vaccine: FLUX
Symptoms: Illness, Influenza
Clinical narrative: flu; sick; Initial information was received on 16-Feb-2021 regarding an unsolicited valid serious case received from a consumer/non-health care professional (patient) via media.  This case involves female patient (age not specified) who had flu (influenza), while she received INFLUENZA VACCINE.  The patient's past vaccination(s) included influenza vaccine in 1973 with first shot as sick for prophylactic vaccination.  Past medical treatment(s) concomitant medication and family history were not provided.  It was unknown if the patient had any medical history, concomitant disease or risk factor.   On an unknown date in 1975, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date were not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient was sick (sickness) hours after each shot and Flu (influenza) (serious, unknown latency) following the administration of INFLUENZA VACCINE. The patient was hospitalized for these events.  It was unknown if the patient experienced any additional symptoms/events.  Patient vowed never again will I take it.  There were no lab data/results available.  It was not reported if the patient received any corrective treatment.  At the time of reporting, the outcome of events were unknown.; Sender's Comments: This case concerns female patient who had influenza and their symptom sickness after vaccination with INFLUENZA VACCINE (unknown manufacturer). The time to onset is unknown. Additional information regarding patient's past medical history, condition at the time of vaccination, lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.
Sex: F
Vaccine: UNK
Symptoms: Pain in extremity
Clinical narrative: Slightly sore arm; This spontaneous case from the was received on 22-Jan-2021 from other non-health professional (consumer) via Agency (reference number: SEQW21-00272) and concerned a female patient of an unreported age.  The patient's concurrent conditions included allergy to polyethylene glycol. The patient's concomitant medications were not reported.   On an unknown date, in the past as reported, the patient was vaccinated with a Fluad Quadrivalent (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59, dose: 0.5 ml, route of administration and anatomical location: not reported) for influenza prophylaxis. The batch number was not reported.   On an unspecified date, an unknown amount of time after receiving Fluad Quadrivalent, the patient experienced slightly sore arm.   On an unspecified date, the patient recovered from the event.  The reporter did not provide a causality assessment.  The case was assessed as non-serious.  Company comment: A patient of unknown age was administered Fluad Quadrivalent. On an unspecified date, an unknown amount of time after receiving Fluad Quadrivalent, the patient experienced slightly sore arm. Causal role of the suspect vaccine is assessed as possibly related.; Sender's Comments: A patient of unknown age was administered Fluad Quadrivalent. On an unspecified date, an unknown amount of time after receiving Fluad Quadrivalent, the patient experienced slightly sore arm. Causal role of the suspect vaccine is assessed as possibly related.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Dry mouth, Feeling abnormal, Limb discomfort, Mental disorder
Clinical narrative: Mental state delayed, arm felt heavy, dry mouth, odd sensation in head-transfer to ER
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache, Hot flush
Clinical narrative: MODERNA COVID-19 Vaccine  Per my sheet instructions I am to report any side effects to this website.   While I do report my daily progress on V-SAFE it does not allow for detailed reporting and it does not have a radio button for hot flashes that WILL NOT GO AWAY.    Approx 30-60 min after the vaccine I did get a headache which has continued (still have it).  I did get dizziness and fatigue which has somewhat subsisted and has gotten better (comes and goes) but the headache remains and now I have hot flashes that came out of nowhere last night.  It continues with the headache.    Nothing has changed from my routine nor have I been around anyone new or traveled recently.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Headache, Influenza like illness
Clinical narrative: Headache, Chills, weakness,  Normal flu like symptoms.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Hypertension, Hypoaesthesia
Clinical narrative: Weakness, dizziness, numbness in face, hypertension-evaluated by EMS and refused transportation.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Alanine aminotransferase normal, Aspartate aminotransferase normal, Blood albumin normal, Blood alkaline phosphatase normal, Blood bilirubin normal
Clinical narrative: Pt presented to ED 45 minutes after receiving 1st dose Pfizer COVID vaccine with elevated BP, itching, rash and hives. Pt PE upon arrival stated that she was in acute distress. Itching,rash,hives,swelling and redness present on pt's back, chest and left arm. Progression: worsening. Moderate severity. Pt had taken lisinopril 10 mg with no improvement. Pt was treated with steroids, H1 and H2 blockers with good response.  02.01.2021 Pt presented to ED with BP of 200/140. Pt reports BP has been elevated since receiving her COVID vaccine on 01.29.2021. Pt exam positive for tinnitis. BP @ 1253 144/98, 1152 170/107, 1130 185/112, 1126 190/124. Pt BP came down with self administered hydralazine.   02.04.21 Pt presents to Ed      with elevated BP of 161/111 and chest pressure. Pt has not had relief with dose of clonidine and hydralazine. She also took a dose of steroid. Pt ROS pos for chest tightness, chest pain and leg swelling. BP improved with anxiolysis.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Blood calcium normal, Blood chloride normal, Blood creatinine normal, Blood glucose normal, Blood magnesium increased
Clinical narrative: Pt presented to ED 45 minutes after receiving 1st dose Pfizer COVID vaccine with elevated BP, itching, rash and hives. Pt PE upon arrival stated that she was in acute distress. Itching,rash,hives,swelling and redness present on pt's back, chest and left arm. Progression: worsening. Moderate severity. Pt had taken lisinopril 10 mg with no improvement. Pt was treated with steroids, H1 and H2 blockers with good response.  02.01.2021 Pt presented to ED with BP of 200/140. Pt reports BP has been elevated since receiving her COVID vaccine on 01.29.2021. Pt exam positive for tinnitis. BP @ 1253 144/98, 1152 170/107, 1130 185/112, 1126 190/124. Pt BP came down with self administered hydralazine.   02.04.21 Pt presents to Ed      with elevated BP of 161/111 and chest pressure. Pt has not had relief with dose of clonidine and hydralazine. She also took a dose of steroid. Pt ROS pos for chest tightness, chest pain and leg swelling. BP improved with anxiolysis.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Blood potassium decreased, Blood pressure increased, Blood sodium normal, Blood urea normal, Carbon dioxide normal
Clinical narrative: Pt presented to ED 45 minutes after receiving 1st dose Pfizer COVID vaccine with elevated BP, itching, rash and hives. Pt PE upon arrival stated that she was in acute distress. Itching,rash,hives,swelling and redness present on pt's back, chest and left arm. Progression: worsening. Moderate severity. Pt had taken lisinopril 10 mg with no improvement. Pt was treated with steroids, H1 and H2 blockers with good response.  02.01.2021 Pt presented to ED with BP of 200/140. Pt reports BP has been elevated since receiving her COVID vaccine on 01.29.2021. Pt exam positive for tinnitis. BP @ 1253 144/98, 1152 170/107, 1130 185/112, 1126 190/124. Pt BP came down with self administered hydralazine.   02.04.21 Pt presents to Ed      with elevated BP of 161/111 and chest pressure. Pt has not had relief with dose of clonidine and hydralazine. She also took a dose of steroid. Pt ROS pos for chest tightness, chest pain and leg swelling. BP improved with anxiolysis.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Differential white blood cell count normal, Discomfort, Emotional distress
Clinical narrative: Pt presented to ED 45 minutes after receiving 1st dose Pfizer COVID vaccine with elevated BP, itching, rash and hives. Pt PE upon arrival stated that she was in acute distress. Itching,rash,hives,swelling and redness present on pt's back, chest and left arm. Progression: worsening. Moderate severity. Pt had taken lisinopril 10 mg with no improvement. Pt was treated with steroids, H1 and H2 blockers with good response.  02.01.2021 Pt presented to ED with BP of 200/140. Pt reports BP has been elevated since receiving her COVID vaccine on 01.29.2021. Pt exam positive for tinnitis. BP @ 1253 144/98, 1152 170/107, 1130 185/112, 1126 190/124. Pt BP came down with self administered hydralazine.   02.04.21 Pt presents to Ed      with elevated BP of 161/111 and chest pressure. Pt has not had relief with dose of clonidine and hydralazine. She also took a dose of steroid. Pt ROS pos for chest tightness, chest pain and leg swelling. BP improved with anxiolysis.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Globulin, Glomerular filtration rate normal, Haematocrit normal, Haemoglobin normal
Clinical narrative: Pt presented to ED 45 minutes after receiving 1st dose Pfizer COVID vaccine with elevated BP, itching, rash and hives. Pt PE upon arrival stated that she was in acute distress. Itching,rash,hives,swelling and redness present on pt's back, chest and left arm. Progression: worsening. Moderate severity. Pt had taken lisinopril 10 mg with no improvement. Pt was treated with steroids, H1 and H2 blockers with good response.  02.01.2021 Pt presented to ED with BP of 200/140. Pt reports BP has been elevated since receiving her COVID vaccine on 01.29.2021. Pt exam positive for tinnitis. BP @ 1253 144/98, 1152 170/107, 1130 185/112, 1126 190/124. Pt BP came down with self administered hydralazine.   02.04.21 Pt presents to Ed      with elevated BP of 161/111 and chest pressure. Pt has not had relief with dose of clonidine and hydralazine. She also took a dose of steroid. Pt ROS pos for chest tightness, chest pain and leg swelling. BP improved with anxiolysis.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site urticaria, Lymphocyte count decreased
Clinical narrative: Pt presented to ED 45 minutes after receiving 1st dose Pfizer COVID vaccine with elevated BP, itching, rash and hives. Pt PE upon arrival stated that she was in acute distress. Itching,rash,hives,swelling and redness present on pt's back, chest and left arm. Progression: worsening. Moderate severity. Pt had taken lisinopril 10 mg with no improvement. Pt was treated with steroids, H1 and H2 blockers with good response.  02.01.2021 Pt presented to ED with BP of 200/140. Pt reports BP has been elevated since receiving her COVID vaccine on 01.29.2021. Pt exam positive for tinnitis. BP @ 1253 144/98, 1152 170/107, 1130 185/112, 1126 190/124. Pt BP came down with self administered hydralazine.   02.04.21 Pt presents to Ed      with elevated BP of 161/111 and chest pressure. Pt has not had relief with dose of clonidine and hydralazine. She also took a dose of steroid. Pt ROS pos for chest tightness, chest pain and leg swelling. BP improved with anxiolysis.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphocyte percentage, Mean cell haemoglobin normal, Mean cell volume normal, Monocyte count normal, Neutrophil count increased
Clinical narrative: Pt presented to ED 45 minutes after receiving 1st dose Pfizer COVID vaccine with elevated BP, itching, rash and hives. Pt PE upon arrival stated that she was in acute distress. Itching,rash,hives,swelling and redness present on pt's back, chest and left arm. Progression: worsening. Moderate severity. Pt had taken lisinopril 10 mg with no improvement. Pt was treated with steroids, H1 and H2 blockers with good response.  02.01.2021 Pt presented to ED with BP of 200/140. Pt reports BP has been elevated since receiving her COVID vaccine on 01.29.2021. Pt exam positive for tinnitis. BP @ 1253 144/98, 1152 170/107, 1130 185/112, 1126 190/124. Pt BP came down with self administered hydralazine.   02.04.21 Pt presents to Ed      with elevated BP of 161/111 and chest pressure. Pt has not had relief with dose of clonidine and hydralazine. She also took a dose of steroid. Pt ROS pos for chest tightness, chest pain and leg swelling. BP improved with anxiolysis.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Neutrophil count normal, Peripheral swelling, Platelet count normal, Protein total normal, Pruritus
Clinical narrative: Pt presented to ED 45 minutes after receiving 1st dose Pfizer COVID vaccine with elevated BP, itching, rash and hives. Pt PE upon arrival stated that she was in acute distress. Itching,rash,hives,swelling and redness present on pt's back, chest and left arm. Progression: worsening. Moderate severity. Pt had taken lisinopril 10 mg with no improvement. Pt was treated with steroids, H1 and H2 blockers with good response.  02.01.2021 Pt presented to ED with BP of 200/140. Pt reports BP has been elevated since receiving her COVID vaccine on 01.29.2021. Pt exam positive for tinnitis. BP @ 1253 144/98, 1152 170/107, 1130 185/112, 1126 190/124. Pt BP came down with self administered hydralazine.   02.04.21 Pt presents to Ed      with elevated BP of 161/111 and chest pressure. Pt has not had relief with dose of clonidine and hydralazine. She also took a dose of steroid. Pt ROS pos for chest tightness, chest pain and leg swelling. BP improved with anxiolysis.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Pulmonary embolism, Rash, Red blood cell count normal, Swelling, Tinnitus
Clinical narrative: Pt presented to ED 45 minutes after receiving 1st dose Pfizer COVID vaccine with elevated BP, itching, rash and hives. Pt PE upon arrival stated that she was in acute distress. Itching,rash,hives,swelling and redness present on pt's back, chest and left arm. Progression: worsening. Moderate severity. Pt had taken lisinopril 10 mg with no improvement. Pt was treated with steroids, H1 and H2 blockers with good response.  02.01.2021 Pt presented to ED with BP of 200/140. Pt reports BP has been elevated since receiving her COVID vaccine on 01.29.2021. Pt exam positive for tinnitis. BP @ 1253 144/98, 1152 170/107, 1130 185/112, 1126 190/124. Pt BP came down with self administered hydralazine.   02.04.21 Pt presents to Ed      with elevated BP of 161/111 and chest pressure. Pt has not had relief with dose of clonidine and hydralazine. She also took a dose of steroid. Pt ROS pos for chest tightness, chest pain and leg swelling. BP improved with anxiolysis.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Troponin normal, Urticaria, White blood cell count normal
Clinical narrative: Pt presented to ED 45 minutes after receiving 1st dose Pfizer COVID vaccine with elevated BP, itching, rash and hives. Pt PE upon arrival stated that she was in acute distress. Itching,rash,hives,swelling and redness present on pt's back, chest and left arm. Progression: worsening. Moderate severity. Pt had taken lisinopril 10 mg with no improvement. Pt was treated with steroids, H1 and H2 blockers with good response.  02.01.2021 Pt presented to ED with BP of 200/140. Pt reports BP has been elevated since receiving her COVID vaccine on 01.29.2021. Pt exam positive for tinnitis. BP @ 1253 144/98, 1152 170/107, 1130 185/112, 1126 190/124. Pt BP came down with self administered hydralazine.   02.04.21 Pt presents to Ed      with elevated BP of 161/111 and chest pressure. Pt has not had relief with dose of clonidine and hydralazine. She also took a dose of steroid. Pt ROS pos for chest tightness, chest pain and leg swelling. BP improved with anxiolysis.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Lethargy
Clinical narrative: Lethargic and run down
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Insomnia, Pruritus, Rash, Urticaria
Clinical narrative: Extreme hive spots beginning at scalp and spreading to knees between 6-12 midnight. Area between hive welts filling in with rash or redness.  Following day, began to spread again around 5 PM - went to ER - prednisone and benedryl administered.  Hives intensified over night disallowing sleep. Next two days hives continued to welt up especially late in the day (having spread to face and neck).  Sunday night seeing the redness between welts start to subside in some areas completely.  Itching continues into Monday morning but not as intense.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain in extremity, Pyrexia, Sleep disorder
Clinical narrative: - Uncontrollable Shivering - Fever - Sore left Arm - Tiredness and fatigue - Kept me up at night
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Limb discomfort
Clinical narrative: "Moderna COVID-19 Vaccine EUA" large reddened area on upper arm, approximately the size of a softball.  warm to touch but does not itch, or hurt
Age: 1.0
Sex: M
Vaccine: IPV
Symptoms: Expired product administered
Clinical narrative: On 4/11/2016, child received two vaccinations that were expired (Hep B, expired 11/1/2015 and Hib expired 10/28/2015)
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site indentation, Injection site rash, Rash erythematous
Clinical narrative: Covid arm.  Red hard rash at injection site
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Ophthalmological examination, Psoriasis
Clinical narrative: Spontaneous vitreous hemorrhage in right eye 46 hours after receiving shot.  Dr. reluctant to attribute to vaccine, and he MAY be correct, but I thought I should report it as a possible adverse event.  Hemorrhage dissipating after 2 weeks and expected to clear completely.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Ear discomfort, Feeling cold, Hypoaesthesia, Limb discomfort, Paraesthesia
Clinical narrative: Thursday after walking down 2 flights of stairs and getting into car numbness occurred in the left neck and lower side of my face. I took advil and it has came and went for the last several days along with numbness and tingling in my left arm and hand.  Yesterday and today the numbness in my face is along my mandible and throughout sometimes I feel strange sensations in my left ear.  This morning I woke with additional numbness and tingling in my left foot and leg. As I have been awake this morning, my left leg feels heavier, tingly and my lower right leg is having some issues.  I am also having an extreme cold sensation in my feet and the thermostat reads 70 and I am dressed with socks and shoes on. My feet are white with no discoloration.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Day 6 - Itching injection site Day 7 - tender injection side. Red circle. Itching. Painful. Soreness into neck and shoulder on left side. Day 8 and 9 - reactions continue Day 9 this report filed.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling
Clinical narrative: 1st lot # given in right arm, 2nd in left arm. About 3 days after first shot my eyes swelled to the point where my upper and lower eyelids were almost touching. I didn?t think much of it but now it?s happened after the second dose as well. First time I took 50mg of Benadryl but it didn?t help and took almost 2 days to subside.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Swollen tongue, Tongue blistering, Tongue ulceration
Clinical narrative: Swollen tongue with ulcers and blisters.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Injection site rash
Clinical narrative: Itching and large rash across my arm around injection site
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Dizziness, Hospitalisation, Nausea, Vital signs measurement
Clinical narrative: Vaccine administered, 10 minutes later pt stated she felt dizzy. She did mention she was anxious after reading possible side effects of COVID vaccine. She started to cry and mentioned the recent loss of a family member. Five minutes later, stated she felt nauseous. Pt crying and requesting for us to call her sister. Denied chest pain, tightness of chest or trouble swallowing. Denied shortness of breath,
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Chills, Fatigue, Insomnia, Myalgia
Clinical narrative: fatigue, burning in nose, myalgia, fever, chills, insomnia, palpitations
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Pyrexia
Clinical narrative: fatigue, burning in nose, myalgia, fever, chills, insomnia, palpitations
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Oral herpes
Clinical narrative: Developed a new SHV1 cold sore outbreak on lower left side of lip. Haven?t had one in a while, so it is possibly related to stimulating my immune system. I keep valacyclovir 500 mg on hand for occasional outbreak, so I began my course of treatment immediately upon feeling the cold sore appear.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site rash, Rash
Clinical narrative: "70 yo wo/man presents for COVID vaccination reaction Began with rash at injection site and on front anterior neckline on 2/18/21. Patient reports tenderness at L upper arm (site of injection)."
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Balance disorder, Chills, Diarrhoea, Headache
Clinical narrative: Severe diarrhea, chills, lack of balance,  weakness, arm pain. Pain in the back of my head.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Pain in extremity
Clinical narrative: Severe diarrhea, chills, lack of balance,  weakness, arm pain. Pain in the back of my head.
Age: 81.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: First dose given Moderna, second dose was given Pfizer.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Pain in extremity, Pruritus
Clinical narrative: Over a week after first shot, arm became painful, hot, and itchy.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Rash, Rash erythematous
Clinical narrative: 3 days after vaccine i got a  Horrible rash from my neck all the way down to my thighs, and its red with fire. its covers my back and arms, everywhere. Went to Patient First and was given prednisone and told to take Benadryl but not helping .
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Myalgia
Clinical narrative: LOSS OF EQUILIBRIAM SORE MUSCLES  LOSS OF BALANCE
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Erythema, Heart rate increased, Palpitations, Rash macular
Clinical narrative: Moderna vaccine administered at 10:33.Prior to the  end of the mandatory15minute observation time, she developed red blotchy areas from her front chest/neck area. She did not complain of any shortness of breath.  She stated she  was "a little dizzy" and could "feel her heart beating".  Radial Heart rate was 146.  Nurse STAT called at 10:49. ED team arrived and transported to ED for examination.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Fatigue, Head discomfort, Headache, Hypersomnia
Clinical narrative: I started with fatigue the afternoon of my 2nd vaccine. Slept from 3:40 that afternoon until the following morning at 5am. Body aches/mild. Worked the next day but had to leave an hour early due to fatigue and body pain. That evening developed nausea. (2-26).  The 27th I had a terrible headache upon waking with increased nausea. Started vomiting around 10am. Unable to take in any liquid until that evening late. The 28th mild headache, more of a heavy headed feeling. Today, March 1st, nausea without vomiting thus far, weak & drained feeling.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Impaired work ability, Nausea, Pain, Vomiting
Clinical narrative: I started with fatigue the afternoon of my 2nd vaccine. Slept from 3:40 that afternoon until the following morning at 5am. Body aches/mild. Worked the next day but had to leave an hour early due to fatigue and body pain. That evening developed nausea. (2-26).  The 27th I had a terrible headache upon waking with increased nausea. Started vomiting around 10am. Unable to take in any liquid until that evening late. The 28th mild headache, more of a heavy headed feeling. Today, March 1st, nausea without vomiting thus far, weak & drained feeling.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: one week post vaccine #2, employee states hives over various areas of body including: belly, thigh, groin, armpit, right arm.  Employee has taken OTC Benadryl. 25mg 3 times per day.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Nausea
Clinical narrative: Nausea ( 3 days) and diarrhea (1 day)
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature increased, Chills, Limb discomfort, Pain
Clinical narrative: I received my vaccine on Friday. When I woke up Sat I had a fever of 101.0 F and body aches and chills so  back I could hardly move. Over the next 3 days all the other symptoms went away but the body aches are still here. I still feel pain all the time every where and my skin if touching it I feel bruised. The pain is not so bad that I can't tolerate it but its a constant ache that does not go away also when I am walking up and down stairs i feel like I am weak and cant extend my legs all the way.  The pain does subside with Tylenol but it just does not go away.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives
Age: 89.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Pt was given Moderna for 1st dose, Pfizer for second. No adverse reaction reported.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dysphagia, Dyspnoea
Clinical narrative: Felt like she couldn't swallow, difficulty breathing, dizzy-sent to ER
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia, Swollen tongue
Clinical narrative: Patient noted tingling to LUE and tongue swelling, no other symptoms.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Throat tightness
Clinical narrative: Throat tightening for about 30 seconds
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site erythema
Clinical narrative: Covid Arm. Redness around injection site. Showed up 10 days after injection.  Lasted a week.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood test normal, Blood thyroid stimulating hormone normal, Chills, Electrocardiogram
Clinical narrative: On the morning of Friday, Feb 5, I had a shaking chill and headache, and my blood pressure was 206/78, pulse 93.  I did not have a fever.  I went to the emergency room, and by the time I got there and was examined, my blood pressure was down to about 175/ 90.   After the brief exam and blood draw / EKG, I was left in the waiting room.  After about 3 hours, I felt better, and asked the nurse about leaving.  She took a final blood pressure, which was about 165 / 90, and I left.     I had a similar, slightly less severe episode a week later, Thursday, Feb 11, and went to urgent care.  Additional testing, including thyroid hormone was all normal.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Urine analysis
Clinical narrative: On the morning of Friday, Feb 5, I had a shaking chill and headache, and my blood pressure was 206/78, pulse 93.  I did not have a fever.  I went to the emergency room, and by the time I got there and was examined, my blood pressure was down to about 175/ 90.   After the brief exam and blood draw / EKG, I was left in the waiting room.  After about 3 hours, I felt better, and asked the nurse about leaving.  She took a final blood pressure, which was about 165 / 90, and I left.     I had a similar, slightly less severe episode a week later, Thursday, Feb 11, and went to urgent care.  Additional testing, including thyroid hormone was all normal.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: Vertigo - 5 minutes. Worst I ever experienced although I haven't experienced much
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Rash macular, Skin discolouration
Clinical narrative: Brown and orange spots about 2 inches in diameter,
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: I had a fever that began about 16 hours after I received my first dose of the vaccine.  The fever escalated throughout the morning to 103.7 degrees before it began declining.  On 2/28 by 12:00 p.m. my temperature broke and was at my normal of 97.9.   No other issues were observed.    I tested positive for COVID-19 on 11/21/20.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Deafness unilateral
Clinical narrative: 11 days after shot, I woke up in the middle of the night and my hearing was gone in left ear. Tested last Tuesday and compared to previous tests showed catastrophic hearing loss. Prescribed Prednisone. After 6 days, notice slight improvement in hearing but still not right.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Acoustic stimulation tests, Blood test, Deafness unilateral, Investigation, SARS-CoV-2 antibody test negative
Clinical narrative: 11 days after shot, I woke up in the middle of the night and my hearing was gone in left ear. Tested last Tuesday and compared to previous tests showed catastrophic hearing loss. Prescribed Prednisone. After 6 days, notice slight improvement in hearing but still not right.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: shortly after vaccine looks like hives that started on my arm and then it went on to  on my chest and back and stomach and today it is on my legs. Called my primary and was told to take Benadryl and it hasn't helped. its gotten worse