chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Lacrimation increased, Myalgia, Nausea, Neck pain
Clinical narrative: muscle aches; eyes watering and won't stop; Neck pain; feeling tired; eyes hurt; feels very weak; headache; Nausea; left arm numbness; left arm tingling; left hand numbness/left side of face and head numb; left hand tingling; Dizziness; This is a spontaneous report from a contactable consumer (patient).  A 46-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot Number: EL1284), intramuscular on 30Dec2020 04:45 at single dose at left deltoid as Covid vaccine for coronavirus.  Medical history was none. There were no concomitant medications. The patient stated that she had Covid vaccine. She had dizziness, headache, nausea, left arm hand numbness and tingling, feels very weak, left side of face and head numb, all on 30Dec2020, neck pain and feeling tired, muscle aches, eyes watering and won't stop, eyes hurt in the morning, all on 31Dec2020. Treatment was None. Headache, eyes watering and won't stop, feels very weak and tired, eyes hurt was reported as worsened. Outcome of Nausea, left arm numbness was recovering, of other events were not recovered.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: muscle aches; eyes watering and won't stop; Neck pain; feeling tired; eyes hurt; feels very weak; headache; Nausea; left arm numbness; left arm tingling; left hand numbness/left side of face and head numb; left hand tingling; Dizziness; This is a spontaneous report from a contactable consumer (patient).  A 46-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot Number: EL1284), intramuscular on 30Dec2020 04:45 at single dose at left deltoid as Covid vaccine for coronavirus.  Medical history was none. There were no concomitant medications. The patient stated that she had Covid vaccine. She had dizziness, headache, nausea, left arm hand numbness and tingling, feels very weak, left side of face and head numb, all on 30Dec2020, neck pain and feeling tired, muscle aches, eyes watering and won't stop, eyes hurt in the morning, all on 31Dec2020. Treatment was None. Headache, eyes watering and won't stop, feels very weak and tired, eyes hurt was reported as worsened. Outcome of Nausea, left arm numbness was recovering, of other events were not recovered.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Tenderness
Clinical narrative: a slight chill the first night; slight tenderness to arms; This is a spontaneous report from a contactable nurse reported for her identical twin sister. A 64-years-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration on 28Dec2020 at single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications included unspecified flu vaccine on 18Dec2020. The patient experienced a slight chill the first night and slight tenderness to arms on 28Dec2020 with outcome of unknown.    Information about Lot/Batch number requested.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Pain in extremity, Pruritus, Urticaria
Clinical narrative: 1 day post vaccine, 3inx3in raised circle hive noted to right upper arm with pain and itching.  increased in size over night to at least 4x4 inches..... on 1/6 early am which is 8 days past vaccination, Arm started itching again and hive noted to be about 1x1 with increasing size and itching.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ear pain, Headache
Clinical narrative: 10 hours later severe pain in the tragus of both ears which woke me up; Headache within 5 minutes which lasted until the next day; This is Spontaneous report from a contactable Other-HCP (patient). A 57-years-old female patient (No pregnant) received first dose bnt162b2 (BNT162B2, lot: EL1284), via an unspecified route of administration on 30Dec2020 17:00 at single dose on Right arm for covid-19 immunisation.  Medical history was none. Concomitant medication included celecoxib (CELEBREX), black cohosh [cimicifuga racemosa] (BLACK COHOSH [CIMICIFUGA RACEMOSA]) and multivitamins. The patient previously took erythromycin and experienced drug hypersensitivity. The patient experienced Headache within 5 minutes (30Dec2020 17:05) which lasted until the next day, then about 10 hours later (31Dec2020 03:00) severe pain in the tragus of both ears which woke her up. It felt like someone was grabbing them with pliers. Still recurs mildly from time to time. No treatment received. The events were reported as non-serious.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: External ear pain, Headache
Clinical narrative: 10 hours later severe pain in the tragus of both ears which woke me up; Headache within 5 minutes which lasted until the next day; This is Spontaneous report from a contactable Other-HCP (patient). A 57-years-old female patient (No pregnant) received first dose bnt162b2 (BNT162B2, lot: EL1284), via an unspecified route of administration on 30Dec2020 17:00 at single dose on Right arm for covid-19 immunisation.  Medical history was none. Concomitant medication included celecoxib (CELEBREX), black cohosh [cimicifuga racemosa] (BLACK COHOSH [CIMICIFUGA RACEMOSA]) and multivitamins. The patient previously took erythromycin and experienced drug hypersensitivity. The patient experienced Headache within 5 minutes (30Dec2020 17:05) which lasted until the next day, then about 10 hours later (31Dec2020 03:00) severe pain in the tragus of both ears which woke her up. It felt like someone was grabbing them with pliers. Still recurs mildly from time to time. No treatment received. The events were reported as non-serious.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pain in extremity, Pyrexia
Clinical narrative: made my arm really sore; fever; nervous; This is a spontaneous report from a contactable consumer (patient).  A 59-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot/batch number and expiration date not reported, via an unspecified route of administration from an unspecified date as single dose for COVID-19 immunization.  The patient's medical history was concomitant medications were not reported.  The patient stated, "where I got my shot made my arm really sore for about three days. On the third day, I ran a low-grade fever-100F. The fever lasted 12 hrs. Now I'm fine. I was a little nervous about traveling but read that there was a side effect." The outcome of the event was unknown.  Information on lot/batch number was requested.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Erythema, Feeling abnormal, Myalgia
Clinical narrative: Approx 730 the evening of the vaccine I was resting laying down with both legs up (horizontally). I suddenly felt a "snap" in my left calf which led to severe muscle pain. I can barely walk. It is still painful today. About the same time I developed chills which lasted till about 1PM today. Within 10 minutes of the shot I was dizzy and nauseous (lasted about 15 min). About 20 minutes after the shot my face turned red and lasted about 5 hours.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Approx 730 the evening of the vaccine I was resting laying down with both legs up (horizontally). I suddenly felt a "snap" in my left calf which led to severe muscle pain. I can barely walk. It is still painful today. About the same time I developed chills which lasted till about 1PM today. Within 10 minutes of the shot I was dizzy and nauseous (lasted about 15 min). About 20 minutes after the shot my face turned red and lasted about 5 hours.
Sex: U
Vaccine: COVID19
Symptoms: Allergy to vaccine, Erythema, Paraesthesia, Pruritus
Clinical narrative: I had the covid vaccine of 12/29 and I  had a little bit of an allergic reaction; Well on 12/30 I had some peanut butter and within 5 minutes I had an extremely itchy palm of hand.; my palm was bright red and a little tingling; my palm was bright red and a little tingling; This is a spontaneous report from a contactable consumer (patient). This patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 29Dec2020 at single dose for COVID-19 immunization. The patient medical history included allergic to peanuts. The patient concomitant medications were not reported. Patient had the covid vaccine of 29Dec2020 and had a little bit of an allergic reaction. As a child patient was very allergic to peanuts but have out grown it as an adult. Well on 30Dec2020 patient had some peanut butter and within 5 minutes patient had an extremely itchy palm of hand. Patient immediately looked and palm was bright red and alittle tingling. Patient went and washed hand. It went completely way after about 30 minutes. Other then that feel fine. Outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Vaccination site pain
Clinical narrative: left sided facial muscle soreness; Arm soreness/by injection in the left arm; This is a spontaneous report from a contactable consumer (patient).  The 30-year-old male patient received BNT162B2(COVID Pfizer vaccine, Batch/lot number: EK9231), via an unspecified route of administration on 31Dec2020 at single dose by injection in the left arm for COVID-19 immunization.  Medical history and concomitant medications were none.  The patient stated that he just got the COVID vaccine an hour ago. Within 20 minutes he developed left sided facial muscle soreness, which was the side he got the vaccine on, and arm soreness, on 31Dec2020. There was no treatment. Outcome of events was not recovered.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Blood pressure increased, Blood pressure measurement, Tinnitus
Clinical narrative: My ear started to ring; My blood pressure was kind of up; Lot of anxiety; This is a spontaneous report from a contactable consumer (patient). A 39-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK9231), via an unspecified route of administration on 30Dec2020 at single dose for covid-19 immunization. Medical history included neuropathy. Concomitant medication included pregabalin (LYRICA) for neuropathy. The patient experienced side effects on 30Dec2020: she had the injection on 30Dec2020 and then about five minutes after like she just walked to sit down, her ear started to ring pretty significantly just like ring in both ears and she spoke with the medical professional there, the nurse was like to see her blood pressure and she did, her blood pressure was kind of up and the ear ring had continued. It never stopped. It got better. She was kind of had a lot of anxiety around this. The outcome of event ear started to ring was resolving, outcome of other events was unknown.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: 2 3/4 in. by 1 3/4 in. area of redness with some swelling and slight itchiness.
Age: 43.0
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Facial pain, Fatigue, Headache, Nasal congestion
Clinical narrative: I am so fatigue, so tired; I have like some lower nasal congestion but it's more or like facial pressure like sinusitis; I have like some lower nasal congestion but it's more or like facial pressure like sinusitis; I have like some lower nasal congestion but it's more or like facial pressure like sinusitis; Now my head is hurting a little bit.; For more than ever I can't either keep myself up; This is a spontaneous report from a contactable consumer (patient). A 43-year-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 30Dec2020 at a single dose for COVID-19 immunization.  Medical history included hypertension, allergy, asthmatic. Concomitant medication included amlodipine for hypertension, hydrochlorothiazide (that's water pill). On 31Dec2020, the patient experienced so fatigue, so tired, so patient had to get out of it. The patient had like some lower nasal congestion but it's more or like facial pressure like sinusitis, head was hurting a little bit, for more than ever patient can't either keep itself up. The outcome of events was unknown.    Information on the Batch/Lot number has been requested.
Age: 43.0
Sex: U
Vaccine: COVID19
Symptoms: Sinusitis
Clinical narrative: I am so fatigue, so tired; I have like some lower nasal congestion but it's more or like facial pressure like sinusitis; I have like some lower nasal congestion but it's more or like facial pressure like sinusitis; I have like some lower nasal congestion but it's more or like facial pressure like sinusitis; Now my head is hurting a little bit.; For more than ever I can't either keep myself up; This is a spontaneous report from a contactable consumer (patient). A 43-year-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 30Dec2020 at a single dose for COVID-19 immunization.  Medical history included hypertension, allergy, asthmatic. Concomitant medication included amlodipine for hypertension, hydrochlorothiazide (that's water pill). On 31Dec2020, the patient experienced so fatigue, so tired, so patient had to get out of it. The patient had like some lower nasal congestion but it's more or like facial pressure like sinusitis, head was hurting a little bit, for more than ever patient can't either keep itself up. The outcome of events was unknown.    Information on the Batch/Lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Headache, Pyrexia
Clinical narrative: Headache; Chills; Joint pain; My fever went up to 102.7; This is a spontaneous report from a contactable nurse. A 54-year-old female patient receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EH9899), via an unspecified route of administration in Left Upper arm on an unspecified date at a single dose for covid. The patient medical history was not reported.  Concomitant medication included magnesium hydroxide (MILK OF MAGNESIA).  The patient called in to report side effects. The patient received the vaccine at 9 am then woke up in the middle of the night with the headache and chills, joint pain, fever that went up to 102.7. Treatment included Tylenol. The nurse considered the events as related to the vaccine. The outcome of the events was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Arthritis
Clinical narrative: flare of arthritis; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 30Dec2020 at single dose for COVID-19 immunization.  Medical history included arthritis from an unknown date and unknown if ongoing.  The patient's concomitant medications were not reported.  The patient received Covid-19 vaccine on 30Dec2020, then he had flare of arthritis in Dec2020 (have this before having the vaccine). Asked if take steroids will affect the Covid-19 vaccine. The outcome of the event was unknown. Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site swelling
Clinical narrative: Arm little bit swollen, the arm that I got the shot on; My body feels like tired; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were unknown) via an unspecified route of administration (arm), on an unspecified date in Dec2020, at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient stated, "I took the COVID vaccine yesterday and my arm has a little bit swollen, the arm that I got the shot on. And my body is just like you know when you are, it just feels like my body feels like tired. I was wondering can I take Tylenol or no? I just have one more question, do you think I should be going to work today?" Outcome of the events was unknown.  Information about lot/batch number has been requested.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Dizziness, Headache
Clinical narrative: It was like mild lower back pain like on the lower left part of my back on top of my buttocks; Pain just seems to be getting worse; Dizziness/Lightheaded; Headache; This is a spontaneous report from a contactable healthcare professional. A 59-year-old female patient received her first dose of bnt162b2 (BNT162B2 also reported as Covid 19 Vaccine; lot number: EL3246; expiration date: unknown), via an unspecified route of administration left upper arm on 30Dec2020 11:30 AM at a single dose for Covid-19 vaccination. The patient has no medical history and concomitant medications. The patient reported that she got her first dose of Pfizer vaccine (COVID-19 Vaccine) yesterday (30Dec2020) and today (31Dec2020), she was having at first it was like mild lower back pain like on the lower left part of her back, on top of her buttocks and now it's getting worse. The patient inquired if it was like a side effect. The patient further stated that yesterday  (30Dec2020), she had a side effects like the dizziness, lightheaded and the headache and that went away after she took Tylenol (treatment) but then today this pain just seems to be getting worse. The paracetamol (TYLENOL) was given to her at hospital yesterday for the headache and the dizziness. She hasn't taken anything today because she was not sure if it is okay for her to take Ibuprofen which is what she would prefer to take. She received her COVID-19 Vaccine at a hospital. The outcome of the events was not recovered.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Blister, Herpes zoster
Clinical narrative: One day after Moderna Covid 19  vaccine   eua my wife noticed a blister on my forehead.  I initially dismissed it as one of those things.  Over the next couple of days the blisters spread in a line on my forehead.  Soon after the blisters were around my ear.  I went to an urgent care and was diagnosed with shingles.  Currently the blisters on my forehead are receding, but the blisters behind my ear are still painful. I received valtrex for the treatment of shingles
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; lot number: EK5730), via an unspecified route of administration on 26Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient got the Covid vaccine on 26Dec2020. The patient's daughter has like a fever yesterday with headache. The patient thinks his/her daughter has Covid and was just tested yesterday, so they still do not have results. Today (01Jan2021) the patient woke up with a headache, a different headache than which he/she usually has, but he/she does not have fever. The patient is not sure if she should report this, but he/she was told to report anything to the Pfizer company. The patient asked if he/she should be tested for Covid as well. The outcome of the event was unknown.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Malaise, Pyrexia
Clinical narrative: she did not felt great/ felt the worst that she had been feeling; temperature was like 100.3/fever; chills; This is a spontaneous report from a contactable other healthcare professional (patient herself). A 33-year-old female patient received bnt162b2 (BNT162B2 also reported as Covid19 Vaccine a Pfizer, lot EH9899, expiry date not reported), via an unspecified route of administration on 29Dec2020, single dose, for Covid-19 immunisation (prevention of Covid-19). Medical history was none. Concomitant medication included PRENATAL VITAMINS. The patient informed she did not felt great the day (29Dec2020) or 2 that when she got the vaccine. She felt the worst that she had been feeling. Her temperature was like 100.3/fever and had chills (29Dec2020). No treatment was taken. The outcome of the events was unknown.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles; This is a spontaneous report from a contactable nurse reporting for herself. A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number PAA156571) via an unspecified route of administration, on 20Dec2020, single dose for COVID-19 immunization. Relevant medical history included hypercholesterolemia. Concomitant medications were not reported.  The patient took unspecified medication for hypercholesterolemia however the patient stopped taking it for a month or two already. The patient got the first Pfizer vaccine shot on work (clinic) on 20Dec2020. On 28Dec2020, the patient developed shingles which is now being treated. The patient does not know if this is because of that or a part of it. The patient never had Shingles before. Outcome of the event was unknown.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Hypertension
Clinical narrative: High blood pressure.  BP went from 146/84 before immunization to 185/90 post immunization.  The day after BP is 193/106 and requires medical evaluation.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache; This is a spontaneous report from a contactable consumer from a Pfizer Sponsored Program. A female patient of an unspecified age received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 02Jan2021 at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient received the vaccine the day prior to the report and she got a headache. The event outcome was unknown.   Information on the lot/batch number has been requested.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Throat irritation
Clinical narrative: scratchy throat; tired; headache; This is a spontaneous report from a contactable nurse (patient).  A 58-year-old female received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry date not reported), intramuscular in 24Dec2020 11:30 at a single dose in the left arm as Covid vaccine. The patient had no medical history. The patient no known allergies. Concomitant medication included propranolol (within the two weeks). The patient had no prior COVID vaccination and was not tested for COVID post vaccination. On an unknown date, the patient experienced scratchy throat, tired, and headache. No treatments received in response to the events reported. The events were reported as not serious (did not result in death, not life-threatening, did not cause/prolonged hospitalization, not disabling/incapacitating and not a congenital anomaly/birth defect). The outcome of the events scratchy throat, tired, and headache was recovered with lasting effects.   Information on the lot/batch number has been requested.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous, Human chorionic gonadotropin negative, Laboratory test, Progesterone normal
Clinical narrative: I had a miscarriage on 01/01/2021  Estimated date of Delivery 09/7/ 2021
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Dehydration, Dizziness, Hyperhidrosis
Clinical narrative: severely dehydrated; sweaty; dizzy; This is a spontaneous report from a non-contactable consumer (patient).  A 30-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot/batch number not reported, via an unspecified route of administration from 03Jan2021 14:30 to 03Jan2021 14:30 as single dose for COVID-19 immunization.  Medical history included allergies to latex, psoriatic arthritis, asthma, migraines and COVID19 prior vaccination.  The patient's concomitant medications were not reported.  The patient previously took Vicodin, Codeine, Imitrex and experienced allergies.  On 03Jan2021 15:00, the patient got severely dehydrated, sweaty, dizzy. The outcome of the events was recovered.  The patient does not received treatment for the events.  No follow-up attempts are possible. Information about lot/batch number cannot be requested. No further information is expected.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Soreness in injection site; This is a spontaneous report from a contactable other healthcare professional (patient). A 43-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK5730), via an unspecified route of administration (arm left) on 31Dec2020 (10:00) to 31Dec2020 10:00 at single dose for Covid-19 immunization. The patient's medical history included GERD (gastroesophageal reflux disease). Concomitant medications were not reported. The patient has no allergy to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient experienced soreness in injection site on 31Dec2020 17:00 with outcome of recovering. There was no treatment received for the adverse event. The patient has not been tested for COVID-19 since the vaccination. This case is non-serious.
Age: 10.0
Sex: F
Vaccine: DT, TD
Symptoms: No adverse event, Wrong product administered
Clinical narrative: given DT instead of Tenivac with no AE; Initial information received on 21-Dec-2020 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional (caregiver of the patient).  This case involves a 10 years old female patient who was given DIPHTHERIA AND TETANUS TOXOIDS instead of DIPHTHERIA AND TETANUS TOXOIDS (Tenivac) (wrong product administered).  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medication was unknown.   The caller said that his daughter had cut her hand on a rusty nail last night and he took her to the ER for a tetanus shot. On 20-Dec-2020, the patient received a once dose of suspect DIPHTHERIA AND TETANUS TOXOIDS instead of DIPHTHERIA AND TETANUS TOXOIDS (Tenivac)(with unknown strength, formulation, dose, frequency and lot number; expiration date: 31-May-2022) via unknown route in unknown administration site.  It was a case of actual medication error due to wrong vaccine administered. (latency same day). He was very frustrated and upset. He wanted to know what side effects she might have.  At the time of report, no adverse event was reported.     There will be no information available on the batch number for this case.    This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in directive 2001/83/ec and module VI of the good pharmacovigilance practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling hot, Flushing
Clinical narrative: Pt received vaccine at 11:45 and was sitting in observation for 8 minutes when he stated he felt like he was getting really warm.  Pt was put in wheelchair and taken to a room to lay down.  Vital signs BP 139/88, P 68, R 20 SP02 98%.  Pt face was flush. No signs of SOB or any other symptoms.  After 10 minutes patient  stated the "hot feeling" was going away.  We monitored him for additional 30 minutes and patient was able to sit up without any difficulties or changes in the way he felt.  Patient was released to his command with no limitations.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: lymphatic reaction in left axillary. Hard painful lymph.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Fatigue, Headache, Nausea, Pain
Clinical narrative: Fever of 101.7 Fahrenheit, body aches, fatigue, nausea, headache, loss of appetite
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever of 101.7 Fahrenheit, body aches, fatigue, nausea, headache, loss of appetite
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Right arm soreness
Age: 33.0
Sex: F
Vaccine: EBZR
Symptoms: Balance disorder, Chest discomfort, Dizziness, Feeling abnormal, Feeling cold
Clinical narrative: 1st dose to L deltoid around 0725. I went at sat down to wait my 15 minutes and approximately 5-10 mins later I immediately began feeling completely flushed, red hot followed by chest tightness and throat tightness.  Upon standing up I felt very dizzy and had a strange sense of 'impending doom'. The RN recording my Vital signs had me take a picture of them to trend and send to the ED which is where I was later sent (see VS below) 0733- bp 171/92, hr 83, sp02 100% "hot flushed, chest tightness" 0735- BP 159/97, HR 91, SP02 99% 0740- BP 170/95, HR 76, SP02 100%, "chest tightness better, no itching, or rash"   0745- BP 155/90, HR 76, SP02 100% 0750- BP 161/94, HR 88, SP02 100% "anxiety,/throat tightness, feeling super hot"- here I again had another episode that felt like total body flushing, and began taking my layers of jackets and scrub cap off feeling diaphoretic. (My normal BP is 120/70's and HR 60's)  Upon standing to get to the w/c to be taken to the ER I remember my legs felt tingly and liquidy like jello and that my balance felt off. I got to the Emergency Room a little before 0825 an hour post vaccine. My chest and throat tightness had improved slightly and the flushing reaction had seemed to stop as I now recall feeling very chilled asking for several blankets. I was monitored in the ER for about 1.5hrs thankfully not requiring any epinephrine.
Age: 33.0
Sex: F
Vaccine: EBZR
Symptoms: Hot flush, Muscular weakness, Paraesthesia, Throat tightness
Clinical narrative: 1st dose to L deltoid around 0725. I went at sat down to wait my 15 minutes and approximately 5-10 mins later I immediately began feeling completely flushed, red hot followed by chest tightness and throat tightness.  Upon standing up I felt very dizzy and had a strange sense of 'impending doom'. The RN recording my Vital signs had me take a picture of them to trend and send to the ED which is where I was later sent (see VS below) 0733- bp 171/92, hr 83, sp02 100% "hot flushed, chest tightness" 0735- BP 159/97, HR 91, SP02 99% 0740- BP 170/95, HR 76, SP02 100%, "chest tightness better, no itching, or rash"   0745- BP 155/90, HR 76, SP02 100% 0750- BP 161/94, HR 88, SP02 100% "anxiety,/throat tightness, feeling super hot"- here I again had another episode that felt like total body flushing, and began taking my layers of jackets and scrub cap off feeling diaphoretic. (My normal BP is 120/70's and HR 60's)  Upon standing to get to the w/c to be taken to the ER I remember my legs felt tingly and liquidy like jello and that my balance felt off. I got to the Emergency Room a little before 0825 an hour post vaccine. My chest and throat tightness had improved slightly and the flushing reaction had seemed to stop as I now recall feeling very chilled asking for several blankets. I was monitored in the ER for about 1.5hrs thankfully not requiring any epinephrine.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Chest discomfort, Chills, Cough, Diarrhoea
Clinical narrative: Headache, chill, body aches, fever, malaise, runny nose, sore throat, loss of taste, night sweats, nausea, diarrhea, chest tightness, dry cough
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Malaise, Nausea, Night sweats, Oropharyngeal pain
Clinical narrative: Headache, chill, body aches, fever, malaise, runny nose, sore throat, loss of taste, night sweats, nausea, diarrhea, chest tightness, dry cough
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Rhinorrhoea, SARS-CoV-2 test negative
Clinical narrative: Headache, chill, body aches, fever, malaise, runny nose, sore throat, loss of taste, night sweats, nausea, diarrhea, chest tightness, dry cough
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Cold sweat, Feeling hot, Hypotension, Pallor
Clinical narrative: pale, clammy, warm, low blood pressure treatment - put client into Trendelenburg position, gave water and snack, took vitals, monitored for extra 20 minutes
Age: 44.0
Sex: F
Vaccine: UNK
Symptoms: COVID-19
Clinical narrative: COVID19 1B
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Myalgia
Clinical narrative: Headache, muscle aches, joint pain, chills, fatigue
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm was sore for 48 hours post injection.   Ibuprofen was used for treatment
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Injection site pain, Lethargy, Pain
Clinical narrative: Moderna COVID-19 Vaccine EUA  Severe pain in injection site.  Fever of 102.4, weak, lethargic, chills, achy all over.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Moderna COVID-19 Vaccine EUA  Severe pain in injection site.  Fever of 102.4, weak, lethargic, chills, achy all over.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Pruritus, Pyrexia, Skin warm
Clinical narrative: Vaccinated on Wednesday, 12/30/2020 about 1:30PM. The next evening, patient's arm started to swell and become hot and started to itch. She had a fever as well. She stated this continued until 1/5/2021.
Age: 37.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Erythema, Pruritus
Clinical narrative: Pt rec'd vaccine. ~1 hour after, pt began noticing redness and itching to R arm, then became more diffuse, to chest and L arm. Redness was nonblanchable. Pt returned to clinic and 50mg IM benadryl was given by supervisor at ~1400. Now (~1420), redness has almost completely resolved. No SOB, chest tightness, wheezing.
Age: 37.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Erythema, Pruritus, Rash macular
Clinical narrative: Pt rec'd vaccine. ~1 hour after, pt began noticing redness and itching to R arm, then became more diffuse, to chest and L arm. Redness was nonblanchable. Pt returned to clinic and 50mg IM benadryl was given by supervisor at ~1400. Now (~1420), redness has almost completely resolved. No SOB, chest tightness, wheezing.
Age: 37.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Erythema, Pruritus
Clinical narrative: Itchiness, redness, blotchy arms
Age: 37.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Erythema, Pruritus, Rash macular
Clinical narrative: Itchiness, redness, blotchy arms
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Dry skin, Injection site erythema, Injection site pruritus, Injection site swelling, Rash macular
Clinical narrative: After the initial, typical, local reaction resolved on Day +3 post-vaccine, I had 4 days with no adverse effects at all.  On Day + 7 (1/5/2021) I woke at 6:00am with my injection site incredibly itchy, but no visible rash or swelling.  Within 2 hours, splotchy rash was overlying the injection site.  Gradually throughout the day, site became confluently red and began to swell.  Itching continued pretty intensely.  Swelling progressed until it was visible from across the room and skin changed texture in the area and feels almost like a thick, waxy, orange peel like texture.  No pain.    Itching resolved with 1 dose of zyrtec.  Did not return.  Redness and swelling persists.  Swelling seems to wax and wane.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling of body temperature change, Flushing, Paraesthesia, Skin discolouration
Clinical narrative: MINUTES AFTER VACCINE WAS ADMINISTERED PATIENT FELT DIZZY THEN COLD FLUSHING FEELING FROM FEET TO HEART AND THEN THAT STOPPED AND TINGLING FEELING THROUGHOUT BODY AND THEN VERY WARM, AND FAINT FEELING.  PATIENT DID NOT FAINT.  PATIENT DID VOMIT ONCE.  PATIENT HAD NOT EATEN BEFORE VACCINATION WAS ADMINISTERED. 1255 VITALS: BP: 126/91 P:100 SAO2  1303 VITALS: BP: 116/99 P: 96 SA02: 100%  PATIENT STATES THEY ARE FEELING BETTER.  GIVEN JUICE AND BANANA.  1312 VITALS: BP: 128/87 P: 74 SA02: 100%  PATIENTS COLOR HAS RETURNED TO NORMAL.  STATES THEY ARE FEELING MUCH BETTER.  ABLE TO STAND AND WALK WITHOUT DIZZINESS.   PATIENT STATED THAT THEY DID NOT FEEL THEY NEEDED ANY FURTHER TREATMENT OR CARE.  PATIENT LEFT WITH HER WORKMATE.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: MINUTES AFTER VACCINE WAS ADMINISTERED PATIENT FELT DIZZY THEN COLD FLUSHING FEELING FROM FEET TO HEART AND THEN THAT STOPPED AND TINGLING FEELING THROUGHOUT BODY AND THEN VERY WARM, AND FAINT FEELING.  PATIENT DID NOT FAINT.  PATIENT DID VOMIT ONCE.  PATIENT HAD NOT EATEN BEFORE VACCINATION WAS ADMINISTERED. 1255 VITALS: BP: 126/91 P:100 SAO2  1303 VITALS: BP: 116/99 P: 96 SA02: 100%  PATIENT STATES THEY ARE FEELING BETTER.  GIVEN JUICE AND BANANA.  1312 VITALS: BP: 128/87 P: 74 SA02: 100%  PATIENTS COLOR HAS RETURNED TO NORMAL.  STATES THEY ARE FEELING MUCH BETTER.  ABLE TO STAND AND WALK WITHOUT DIZZINESS.   PATIENT STATED THAT THEY DID NOT FEEL THEY NEEDED ANY FURTHER TREATMENT OR CARE.  PATIENT LEFT WITH HER WORKMATE.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: Fever of 100.3, headache, chills, body aches
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Swelling, Swollen tongue
Clinical narrative: Patient woke on 1/01/2021 with headache; swelling of left-side of neck; swelling of tongue
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Injection site pain, Pain, Pyrexia
Clinical narrative: Lo grade fever, body aches, fatigue, pain at injection site
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, SARS-CoV-2 test negative
Clinical narrative: Employee stated she felt dizzy shortly after receiving vaccine. Assessed by RN and EMT's and rested for 30 minutes then went home.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Dose 1 administered on 12/28/2020 Fatigue and body aches on 12/29/2020 morning, resolved by afternoon Tender left axillary lymphadenopathy 01/03/2021-present Swelling, warmth, itchiness, soreness at injection site on 01/04/2021-01/06/2021
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain, SARS-CoV-2 test
Clinical narrative: Dose 1 administered on 12/28/2020 Fatigue and body aches on 12/29/2020 morning, resolved by afternoon Tender left axillary lymphadenopathy 01/03/2021-present Swelling, warmth, itchiness, soreness at injection site on 01/04/2021-01/06/2021
Age: 12.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Dizziness, Muscular weakness, Nausea, Vision blurred
Clinical narrative: Patient felt lightheaded, nauseated, blurred vision. Legs and body got weak. Episode occurred momentarily after patient received injection and lasted moments. Pt. improved once laid down and feet elevated. Patient evaluated and treated on site at school by nurse practitioner.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: About 1 week after receiving the vaccine I noticed my right arm itching, it took me a while to realize why. Once I looked at my arm in a mirror I saw that it was swollen, red & itchy. At the time the redness was about the side of a 1/2 dollar. The last few days I have noticed that my arm is itchy, red, swollen & now feels like a rash in the same location but the redness is about the size of a baseball.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site warmth, Pallor, Urticaria
Clinical narrative: Presented with pain at injection site for days1-4 followed by flat, blanchable welt on left deltoid that was warm to touch and erythemic, approximately 1.5?x2.5? in size, on day 10.  Afrebile.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Pruritus, Urticaria
Clinical narrative: Shortness of breath, hives, and itching.  Took benadryl, famotidine, Xyzal at time of reaction.  Also 4 puffs on ventolin. Symptoms slowly improved over 4 hours.  Epiniphrine not administered.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Pruritus, Tenderness
Clinical narrative: Left arm swelled, red, itchy, tender 1 week after injection. Only sore the day or 2 after injection snd then the symptoms started one week to the day of the shot
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache for 7 days then resolved
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Ultrasound scan
Clinical narrative: Significant left subclavicular lymphadenopathy; single area measured 10 mm on ultrasound.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray normal, Chest discomfort, Computerised tomogram normal, Diarrhoea, Dyspnoea
Clinical narrative: 12/26/2020: Nausea, vomiting, diarrhea for 24 hours 12/29/2020: shortness of breath, chest tightness for 36 hours. Went to ER. COVID and flu tests done. Both negative.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Fibrin D dimer increased, Influenza virus test negative, Nausea, SARS-CoV-2 test negative, Vomiting
Clinical narrative: 12/26/2020: Nausea, vomiting, diarrhea for 24 hours 12/29/2020: shortness of breath, chest tightness for 36 hours. Went to ER. COVID and flu tests done. Both negative.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Injection area is red, swollen, warm to touch
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, C-reactive protein normal, Headache, Loss of personal independence in daily activities, Lymphadenopathy
Clinical narrative: patient received vaccine on dec 18th.  on dec 30th patient started experiencing extreme hand and joint pain and had to take analgesics.  Pain radiated through her upper body and at times was shooting.  she was unable to perform ADLs.  She then developed an itchy rash all over her upper body as well as a headache and swollen lymph nodes.  Covid test was negative, CRP was 3.6 and sed rate was 25.  all other labsl WNL,   symptoms resolved after 5 days
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Rash, Rash pruritic, Red blood cell sedimentation rate normal
Clinical narrative: patient received vaccine on dec 18th.  on dec 30th patient started experiencing extreme hand and joint pain and had to take analgesics.  Pain radiated through her upper body and at times was shooting.  she was unable to perform ADLs.  She then developed an itchy rash all over her upper body as well as a headache and swollen lymph nodes.  Covid test was negative, CRP was 3.6 and sed rate was 25.  all other labsl WNL,   symptoms resolved after 5 days
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test negative
Clinical narrative: patient received vaccine on dec 18th.  on dec 30th patient started experiencing extreme hand and joint pain and had to take analgesics.  Pain radiated through her upper body and at times was shooting.  she was unable to perform ADLs.  She then developed an itchy rash all over her upper body as well as a headache and swollen lymph nodes.  Covid test was negative, CRP was 3.6 and sed rate was 25.  all other labsl WNL,   symptoms resolved after 5 days
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Burning sensation, Dizziness, Hypoaesthesia, Injection site swelling
Clinical narrative: It was noted during injection a tremendous amount of pain/stinging/burning that lasted a few minutes. About 20 minutes post injection, numbness/tingling noted in pinky/5th finger radiating down palm to wrist on same arm as injection as well as dizziness. Notified observation RNs and moved to a separate room. Mildly elevated BP but normal HR noted. No rash/hives/difficulty breathing. Numbness and tingling would migrate - most often to thumb but sometimes up entire arm. Released 1 hour after injection after no life threatening signs noted.  Visited PCP the next day (1/6) at 10:15. Professional opinion that it is due to swelling from injection - now noticeable area of swelling around injection site. Recommended ice and NSAIDs.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Paraesthesia
Clinical narrative: It was noted during injection a tremendous amount of pain/stinging/burning that lasted a few minutes. About 20 minutes post injection, numbness/tingling noted in pinky/5th finger radiating down palm to wrist on same arm as injection as well as dizziness. Notified observation RNs and moved to a separate room. Mildly elevated BP but normal HR noted. No rash/hives/difficulty breathing. Numbness and tingling would migrate - most often to thumb but sometimes up entire arm. Released 1 hour after injection after no life threatening signs noted.  Visited PCP the next day (1/6) at 10:15. Professional opinion that it is due to swelling from injection - now noticeable area of swelling around injection site. Recommended ice and NSAIDs.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Chest X-ray, Dizziness, Electrocardiogram, Laboratory test
Clinical narrative: Pt's only real complaint: mild lightheadedness/dizziness.  No CP, SOB, cough, throat swelling, difficulty swallowing, stridor, syncope, neuro deficits, HA, fever, chills, nausea, vomiting or pain of any kind.   Patient was evaluated and workup was done in ED: EKG, CXR, labs.  Patient was observed for ~2 hours after which his symptoms were totally gone and patient was sent home with normal vitals and without complaints of any kind.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Swelling, Swelling face, Swollen tongue
Clinical narrative: 23 hours after vaccine, had facial and neck swelling and tongue swelling. Had difficulty swallowing. Took Benadryl 50 mg. Happened again after 2 hours (25 hours after vaccine), took another Benadryl 50 mg. Then happened one more time about 36 hours after vaccine, had to use epipen, took Benadryl and Claritin as well. Symptoms improved and throat opened.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: 9 days after getting first dose of covid vaccine I woke up with my arm having a big red circle where the injection has been administered on 12/28/2020.  The sight felt a little warm . Didn't hurt.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Antineutrophil cytoplasmic antibody negative, Antinuclear antibody, Blood creatine phosphokinase, Blood heavy metal test, Blood magnesium
Clinical narrative: 3 days after shot, excruciating quad pain, lower leg weakness, inability to stand
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Dysstasia, Electromyogram, Full blood count, Inappropriate schedule of product administration, Laboratory test
Clinical narrative: 3 days after shot, excruciating quad pain, lower leg weakness, inability to stand
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Lumbar puncture, Magnetic resonance imaging brain, Magnetic resonance imaging spinal, Metabolic function test, Muscular weakness
Clinical narrative: 3 days after shot, excruciating quad pain, lower leg weakness, inability to stand
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Red blood cell sedimentation rate, Vitamin B6
Clinical narrative: 3 days after shot, excruciating quad pain, lower leg weakness, inability to stand
Age: 49.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Chills, Body Aches, Fever of 101/102 for 3 days.
Age: 49.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Chills, Pain, Pyrexia
Clinical narrative: Chills, Body Aches, Fever of 101/102 for 3 days.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Blood pressure increased, Chest discomfort, Dizziness, Flushing
Clinical narrative: Felt flushed, at one point felt faint, anxious, heart racing. BP 134/90 HR 80 @ 1125. Reported chest tightness and anxious a few minutes later. BP 150/108 HR 80 @ 1141. Assisted to Emergency Department across the street.