chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Somnolence
Clinical narrative: dizzy; sleepy; This is a spontaneous report from a contactable consumer (patient).  A 67-year-old male consumer received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 21Jan2021 at single dose for COVID-19 immunisation at the age of 67-year-old. Medical history included blood pressure diagnosed year before the report (3-5 years). Concomitant medications were unspecified. The patient took the Covid-19 vaccine on 21Jan2021, and he has been feeling a little dizzy and sleepyin the afternoon of 21Jan2021, his wife was concerned so he was wondering what could be going on. The patient did not recover from the events. Information on the Lot/Batch Number has been requested.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Injection site erythema
Clinical narrative: fatigue, joint pain, chills, muscle pain, headache, redness at injection site, hardness at injection site (Self administered Ibuprofen 600 mg q8 X 3 doses)
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site induration, Myalgia
Clinical narrative: fatigue, joint pain, chills, muscle pain, headache, redness at injection site, hardness at injection site (Self administered Ibuprofen 600 mg q8 X 3 doses)
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: Approximately 2/3rds of the arm has swollen up/ mild swelling; her arm is still red, this happened after the second dose/ it was very red and warm and itching/ it was a red area about 5 cm in diameter around the injection site in the upper arm; it was very red and warm and itching; Soreness of the arm/It hurt, it was warm, slightly swollen and raised from rest of the skin; It hurt, it was warm, slightly swollen and raised from rest of the skin. It was initially located in like the back of the arm, right where the shot was given; It hurt, it was warm, slightly swollen and raised from rest of the skin. It was initially located in like the back of the arm, right where the shot was given; This is a spontaneous report from a contactable Physician.  A 76 year old female Physician reported that she received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EK4176 Expiry date 31Mar2021), at single dose in the left Arm on 14Jan2021 at 2:30PM for COVID-19 immunization. The patient had received the first dose of BNT162B2 (lot E11865, Exp Mar2023) in the left arm on 23Dec2020 . Medical history included asthma and allergy. She had a contrast IV reaction before. She is Allergic to everything, inhalants, weeds, dust, trees, grasses, foods like chickpeas that have her bad asthma and fishes like Halibut. When she did a skin test she reacts to everything. She has been on prednisone. She was admitted to the hospital a year ago in November for an asthma attack. Concomitant drugs included inhalant steroid medication and other medication for Asthma.  The patient reported that on 15Jan2021 after the second dose, approximately 2/3rds of the arm has swollen up, this lasted about 7 days. On the 8th day and it is beginning to go down. She also added that her arm was still red. The mild swelling actually started as itching, within 10-12 hours, when she woke up and looked it was a red area about 5 cm in diameter around the injection site in the upper arm. It hurt, it was warm, slightly swollen and raised from rest of the skin. It was initially located in like the back of the arm, right where the shot was given, like upper back of arm. On 16Jan2021, it was close to half of the upper arm, well not exactly half the arm, but it was very red and warm and itching, on the left Arm.  On 17Jan2021 it was at 2/3rd of the arm, almost 15 cm's in length at that point. Still very red, it wrapped towards the front of the arm, she could see the color without looking in the mirror.  The swelling has ended, the raise part stopped around the 19Jan2021.  The redness as of the 19Jan2021, it was less, the skin is slight pink, pinker than the normal skin, she has put some steroid cream skin lotion on the red area, she did that on 16Jan2021 twice a day. She also took Benadryl for 2 nights on 16Jan2021 and 17Jan2021.  The itching stopped, when the skin was covered it was not that bad, but when the air hits it, it itches. Caller also added that there was soreness on the arm, it was achy, but it was very minimal now, she notices it when lifting things, that was when it hurts.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Diarrhea; This is a spontaneous report from a contactable consumer, the patient.  A non-pregnant 77-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: CO87750), via an unspecified route of administration, in the left arm on 20Jan2021 at 10:45 AM (at the age of 77-year-old) as a single dose for COVID-19 immunization. Medical history included ongoing arthritis, congestive heart failure, open heart surgery in 2010.  There were no concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 21Jan2021, the patient experienced diarrhea. The patient reported "this morning" she had diarrhea. She had it again within the hour. The clinical outcome of diarrhea was not recovered.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash, just progressed worse; This is a spontaneous report from a contactable consumer.  A 23-year-old female consumer reported that received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EL3249), at single dose into left arm on 17Jan2021 6at :00 p.m for COVID-19 immunization. Medical history and concomitant drugs were none. The patient reported experiencing a rash. The rash started on her wrist and has just progressed worse in the past few days. She got her shot on Saturday. Her rash fist appeared on Sunday or Monday, she cannot totally recall. The rash has continued to progress worse. Caller states the rash was all over the body. The caller states she has to assume this is a reaction to the vaccine, it's too coincidental not to be. The caller is just wondering if there is any information on what she can do about the rash, if it is safe to get the second vaccine and if she can receive a steroid shot. The outcome of the event was not recovered.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash on left side of back in one spot on Sunday 1-31-21, two days after vaccine was given in left deltoid.
Sex: U
Vaccine: COVID19
Symptoms: Flushing, Headache, Hypersensitivity, Pain, Pyrexia
Clinical narrative: allergy sneezing attack; flushing in face/flush in the face/flush in the face and it's very red and swollen; flush in the face and it's very red and swollen; allergy sneezing attack; Headache; Aches and pain; Fever; This is a spontaneous report from a contactable consumer (patient).  A patient of unspecified age and gender received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number requested), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history was not reported.  Concomitant medication included diphenhydramine hydrochloride (BENADRYL). It was reported that the patient had the Pfizer COVID vaccine and have had reactions (unspecified) to other medicines (unspecified medication) so the patient stayed (as reported) for about half an hour and did fine but about half an hour later on the way home the patient started getting flushing in face and like an allergy sneezing attack and then when the got home the patient got a headache and noted fever and the aches and pain are normal but had a flush in the face and it's very red and swollen. The patient wanted to know before going for the second one, can he/she take Benadryl because the patient stated that he/she took Benadryl when he/she came home. The outcome of the events was unknown.   Information on Batch/Lot number was requested.
Sex: U
Vaccine: COVID19
Symptoms: Sneezing, Swelling face
Clinical narrative: allergy sneezing attack; flushing in face/flush in the face/flush in the face and it's very red and swollen; flush in the face and it's very red and swollen; allergy sneezing attack; Headache; Aches and pain; Fever; This is a spontaneous report from a contactable consumer (patient).  A patient of unspecified age and gender received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number requested), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history was not reported.  Concomitant medication included diphenhydramine hydrochloride (BENADRYL). It was reported that the patient had the Pfizer COVID vaccine and have had reactions (unspecified) to other medicines (unspecified medication) so the patient stayed (as reported) for about half an hour and did fine but about half an hour later on the way home the patient started getting flushing in face and like an allergy sneezing attack and then when the got home the patient got a headache and noted fever and the aches and pain are normal but had a flush in the face and it's very red and swollen. The patient wanted to know before going for the second one, can he/she take Benadryl because the patient stated that he/she took Benadryl when he/she came home. The outcome of the events was unknown.   Information on Batch/Lot number was requested.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Pt. after the fact disclosed she had another vaccine 7 days prior to the second does of COVID-19 vaccine. She stated that her PCP said it would be okay to still receive the COVID-19 in a week.  PCP notified that no vaccine should be given prior to or post vaccine for 14 days and no vaccine should be given in between the two doses.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Allergy test, Anaphylactic reaction, Body temperature increased, Dry mouth, Hypoaesthesia oral
Clinical narrative: anaphylactic reaction; had a fever of 100.8; This is a spontaneous report from a  nurse reporting for herself.    A 30-years-old female patient received the first dose of bnt162b2 (BNT162B2; Lot # EL0140) vaccine  , via an unspecified route of administration on 13Jan2021 at single dose for Covid-19 prophylaxis .  Medical history included ongoing asthma Diagnosed when she was a child , seasonal allergy  , food allergy  , contrast media allergy (gadolinium).  There were no concomitant medications. The patient experienced anaphylactic reaction on 13Jan2021 with outcome of recovered , had a fever of 100.8  on 13Jan2021 with outcome of recovered.  The patient underwent lab tests and procedures which included allergy test: unknown results   on Jan2021   , body temperature: 100.8   on 13Jan2021. The reaction began 28 minutes later. She says she started to get jumpy, her hands swelled and got itchy. She couldn't bend her hands, they were so swollen that she couldn't bend them. Her legs were shaking. Then saline and eventually her mouth started to get numb and they used an Epi pen twice. Her throat never closed, she thinks it did not close because the Epi pen was done twice, She had 2 masks on she cannot say for sure if she had trouble breathing but her mouth began to get dry and tingly and she started to no be able to feel her mouth. She says she would says it was resolved completely the next day.  The patient also received Decadron and  Benadryl. The reporter would say the event were life threatening because they treat it that way due to anaphylaxis precautions.   Follow up information has been requested.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Nervousness, Paraesthesia oral, Peripheral swelling, Pruritus
Clinical narrative: anaphylactic reaction; had a fever of 100.8; This is a spontaneous report from a  nurse reporting for herself.    A 30-years-old female patient received the first dose of bnt162b2 (BNT162B2; Lot # EL0140) vaccine  , via an unspecified route of administration on 13Jan2021 at single dose for Covid-19 prophylaxis .  Medical history included ongoing asthma Diagnosed when she was a child , seasonal allergy  , food allergy  , contrast media allergy (gadolinium).  There were no concomitant medications. The patient experienced anaphylactic reaction on 13Jan2021 with outcome of recovered , had a fever of 100.8  on 13Jan2021 with outcome of recovered.  The patient underwent lab tests and procedures which included allergy test: unknown results   on Jan2021   , body temperature: 100.8   on 13Jan2021. The reaction began 28 minutes later. She says she started to get jumpy, her hands swelled and got itchy. She couldn't bend her hands, they were so swollen that she couldn't bend them. Her legs were shaking. Then saline and eventually her mouth started to get numb and they used an Epi pen twice. Her throat never closed, she thinks it did not close because the Epi pen was done twice, She had 2 masks on she cannot say for sure if she had trouble breathing but her mouth began to get dry and tingly and she started to no be able to feel her mouth. She says she would says it was resolved completely the next day.  The patient also received Decadron and  Benadryl. The reporter would say the event were life threatening because they treat it that way due to anaphylaxis precautions.   Follow up information has been requested.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Throat tightness, Tremor
Clinical narrative: anaphylactic reaction; had a fever of 100.8; This is a spontaneous report from a  nurse reporting for herself.    A 30-years-old female patient received the first dose of bnt162b2 (BNT162B2; Lot # EL0140) vaccine  , via an unspecified route of administration on 13Jan2021 at single dose for Covid-19 prophylaxis .  Medical history included ongoing asthma Diagnosed when she was a child , seasonal allergy  , food allergy  , contrast media allergy (gadolinium).  There were no concomitant medications. The patient experienced anaphylactic reaction on 13Jan2021 with outcome of recovered , had a fever of 100.8  on 13Jan2021 with outcome of recovered.  The patient underwent lab tests and procedures which included allergy test: unknown results   on Jan2021   , body temperature: 100.8   on 13Jan2021. The reaction began 28 minutes later. She says she started to get jumpy, her hands swelled and got itchy. She couldn't bend her hands, they were so swollen that she couldn't bend them. Her legs were shaking. Then saline and eventually her mouth started to get numb and they used an Epi pen twice. Her throat never closed, she thinks it did not close because the Epi pen was done twice, She had 2 masks on she cannot say for sure if she had trouble breathing but her mouth began to get dry and tingly and she started to no be able to feel her mouth. She says she would says it was resolved completely the next day.  The patient also received Decadron and  Benadryl. The reporter would say the event were life threatening because they treat it that way due to anaphylaxis precautions.   Follow up information has been requested.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: Headache, body ache. Fever around 7:00 PM MST continues throughout the night
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Injection site pain, Pain in extremity
Clinical narrative: I experienced pain at the injection site and my whole arm but much lesser, milder than the first dose. I also had with this dose shortness of breath (I have asthma) and I would say the pain in my arm lasted for about 3 days or so. The shortness of breath was only the day of the vaccination. I used my inhaler and was fine.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Injection site pain, Injection site swelling
Clinical narrative: Mild headache, soreness and swelling of the injection site, fatigue for 24-48 hours.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Swelling, Urticaria
Clinical narrative: head to toe hives, itching, swelling
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Cough, Headache, Oropharyngeal pain
Clinical narrative: ICC Note-presenting today for Sore Throat (coughing, headache, chest tightness, onset: 2days )
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chills, Neck pain, Nervousness, Pain in extremity
Clinical narrative: chills, shaky, neck pain, arm pain, stomach upset
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dizziness, Fatigue, Memory impairment, Nausea
Clinical narrative: Dizziness, nausea, fatigue, blurred vision, feeling of forgetfulness. I almost feel like I drank a glass of wine. Just worn out. the first day I had diarrhea.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: Dizziness, nausea, fatigue, blurred vision, feeling of forgetfulness. I almost feel like I drank a glass of wine. Just worn out. the first day I had diarrhea.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Nausea, Pain in extremity
Clinical narrative: Arm soreness, muscle aches, headache, chills and fever  of 101.3 which began at 2:30 am on 2/3/2021 and lasted until 1:00 am on 2/4/2021 nausea began at the same time but is still ongoing.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Arm soreness, muscle aches, headache, chills and fever  of 101.3 which began at 2:30 am on 2/3/2021 and lasted until 1:00 am on 2/4/2021 nausea began at the same time but is still ongoing.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Fatigue, Headache, Pain
Clinical narrative: Chills, fever, exhaustion,  soreness in arm and shoulder, headache, and soreness in the body.  I rested for two days and drank fluids.  I treated it like the flu and used a heating pad on the injection site, and soaked in an Epson salt bath.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Chills, fever, exhaustion,  soreness in arm and shoulder, headache, and soreness in the body.  I rested for two days and drank fluids.  I treated it like the flu and used a heating pad on the injection site, and soaked in an Epson salt bath.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: Woke up with body aches and headache. By noon fever of 101.4 - continued throughout Saturday. Sunday full recovery.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse event, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: One week post injection on 1/25/21 the site became very itchy, red and swollen.  Became progressively worse over 2 days and I went to my MD who felt it was an adverse event.  Today on 2/04 it may be resolving as is less itchy and red/swollen although the red area has traveled further down my arm but hasn't made it to the elbow.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling abnormal, Headache, Insomnia
Clinical narrative: Chills, headache, fatigue, brain fog, difficulty sleeping. Started approximately 12 hours after injection
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate abnormal, Pain in extremity, Vertigo
Clinical narrative: Slight vertigo, rapid heart rate despite taking metapropol (90 - 94), arm pain. All are still ongoing
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Diarrhoea, Headache, Injection site pain, Lymphadenopathy
Clinical narrative: pain at the injection site , fever 102. joint pain , swelling of lymp notes, diarrhea . headaches .
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: pain at the injection site , fever 102. joint pain , swelling of lymp notes, diarrhea . headaches .
Age: 77.0
Sex: F
Vaccine: PNC13
Symptoms: Inflammation, Peripheral swelling
Clinical narrative: LITTLE INFLAMATION IN ARM AND SWELLING
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Dizziness, Fatigue, Headache, Impaired work ability
Clinical narrative: SEVERE ARM PAIN THAT SPREAD INTO SHOULDER BLADES, NASEAU, DIZZINESS, EXHAUSTION, SEVER HEAD ACHE, UNABLE TO GO TO WORK THE NEXT DAY.  2 DAYS LATER STILL ARM PAIN AND HEADACHE
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity
Clinical narrative: SEVERE ARM PAIN THAT SPREAD INTO SHOULDER BLADES, NASEAU, DIZZINESS, EXHAUSTION, SEVER HEAD ACHE, UNABLE TO GO TO WORK THE NEXT DAY.  2 DAYS LATER STILL ARM PAIN AND HEADACHE
Age: 80.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Inflammation, Pain, Pruritus, Rash, Swelling
Clinical narrative: began day 7 after injection with itching on back on scapula under bra on one side; day 8 itched on back under bra both sides;day 9 woke at 1:00 am with SEVERE itching and inflammation over both shoulders and upper back and took 2 Benedryl .  At 8:50 called GP for help who prescribed 1 Zyrtec twice a day + 2 Benedryl per 4 hours + Cortisone 10 mg cream 3 times/day.  At 4:40pm  such intense itching and pain  doctor prescribed Methylprednisolone pack which I started at 6pm.   Rash progressed Jan 31, Feb 1,2,3 to cover whole body.  Worst in armpits with swelling.  Slept with numerous cold gel packs.  Inflammation began subsiding day 6, taking just Zyrtec + cream today day 7.
Age: 80.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Discomfort, Lymphadenopathy, Pyrexia, Rash
Clinical narrative: began day 7 after injection with itching on back on scapula under bra on one side; day 8 itched on back under bra both sides;day 9 woke at 1:00 am with SEVERE itching and inflammation over both shoulders and upper back and took 2 Benedryl .  At 8:50 called GP for help who prescribed 1 Zyrtec twice a day + 2 Benedryl per 4 hours + Cortisone 10 mg cream 3 times/day.  At 4:40pm  such intense itching and pain  doctor prescribed Methylprednisolone pack which I started at 6pm.   Rash progressed Jan 31, Feb 1,2,3 to cover whole body.  Worst in armpits with swelling.  Slept with numerous cold gel packs.  Inflammation began subsiding day 6, taking just Zyrtec + cream today day 7.
Age: 80.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Inflammation, Pain, Pruritus, Rash, Swelling
Clinical narrative: PER PATIENT, FULL BODY RASH ONSET 8 DAYS AFTER VACCINATION STARTING 1/28/21.  INTENSIFIED TO AXILLARY SWELLING/DISCOMFORT ~3 DAYS LATER 1/31/21 AS WELL AS CHILLS AND LOW GRADE FEVER. AS OF 2/4/21, PATIENT INDICATES MAJORITY OF SYMPTOMS HAVE RESOLVED. PATIENT INSTRUCTED BY PCP TO AVOID DOSE 2 OF MODERNA AND SEEK AN ALTERNATIVE, NON MRNA FORMULATION OF VACCINE WHEN MADE AVAILABLE.  MANAGED SYMPTOMS WITH METHYLPREDNISOLONE DOSE PACK, BENADRYL Q4H PRN SYMPTOMS, AND TOPICAL HYDROCORTISONE.
Age: 80.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Discomfort, Lymphadenopathy, Pyrexia, Rash
Clinical narrative: PER PATIENT, FULL BODY RASH ONSET 8 DAYS AFTER VACCINATION STARTING 1/28/21.  INTENSIFIED TO AXILLARY SWELLING/DISCOMFORT ~3 DAYS LATER 1/31/21 AS WELL AS CHILLS AND LOW GRADE FEVER. AS OF 2/4/21, PATIENT INDICATES MAJORITY OF SYMPTOMS HAVE RESOLVED. PATIENT INSTRUCTED BY PCP TO AVOID DOSE 2 OF MODERNA AND SEEK AN ALTERNATIVE, NON MRNA FORMULATION OF VACCINE WHEN MADE AVAILABLE.  MANAGED SYMPTOMS WITH METHYLPREDNISOLONE DOSE PACK, BENADRYL Q4H PRN SYMPTOMS, AND TOPICAL HYDROCORTISONE.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Heart rate increased, Palpitations, Skin warm
Clinical narrative: Pt developed a sense of warmth, palpitation/heart racing and lightheadedness appx. 2 minutes after injection. Symptoms lasted a few minutes. HR initially was 120 but improved to within a normal range within several minutes. BP was 150/90 and SPO2 was >95%. Pt's symptoms resolved after several minutes and she departed without issue.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Malaise, Pain, Pyrexia
Clinical narrative: High fever, malaise, full body aches and chills that came on ~ 8 hrs after the 2nd vaccination and lasted ~ 24 hours.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Pain
Clinical narrative: Around 7pm I had shortness of breath and body aches.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Influenza like illness, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Hives on arm shot received on, flu-like symptoms, 102 fever, painful body aches, dizziness, little urination, nausea, swollen sore hot arm.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Pyrexia, Urine output decreased, Urticaria
Clinical narrative: Hives on arm shot received on, flu-like symptoms, 102 fever, painful body aches, dizziness, little urination, nausea, swollen sore hot arm.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood test normal, Dizziness, Electrocardiogram normal, Heart rate decreased
Clinical narrative: pt states about 5 minutes after vax her arm was sore and her heart was racing, then she got light headed feeling like she was going to pass out.  Her BP was 180/100 and heart rate was in the thirties.  Pt was then transported to the ER by the staff that administered vax.  Pt had EKG and blood work.  Pt was given IV fluid sand released from ER after everything returned to normal.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Palpitations
Clinical narrative: pt states about 5 minutes after vax her arm was sore and her heart was racing, then she got light headed feeling like she was going to pass out.  Her BP was 180/100 and heart rate was in the thirties.  Pt was then transported to the ER by the staff that administered vax.  Pt had EKG and blood work.  Pt was given IV fluid sand released from ER after everything returned to normal.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling cold, Nasal congestion, Pain, Pyrexia
Clinical narrative: I received the shot at 1030 in the morning.  Just after midnight of the next day, I woke up with a fever of 100.9, chills and body aches.  I did have some head congestion too.  It's now 1100am and I still have the same symptoms.  However the fever has dropped closer to 100.  I've been taking Tylenol to help with the aches and fever.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased
Clinical narrative: Heart rate at 210 for approx. 10-15 mins.  I was driving when event occurred and I had to pull over and wait until heart rate came down.  I have Exercise induced but never had a SVT event without exercise like this.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site discomfort, Injection site pain, Injection site swelling, Peripheral swelling
Clinical narrative: Swelling at injection site;  Swelling around entire upper arm, swelling in arm pit and down rib cage.  Tenderness and discomfort associated with swelling.
Age: 31.0
Sex: F
Vaccine: UNK
Symptoms: Cold sweat, Lip swelling, Skin warm
Clinical narrative: Warm Ears, Clammy Hands, Swelling of upper lip
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain, Vomiting
Clinical narrative: Vomited 10 times, lost 6 pounds, intense chills/body aches, very tired
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site pruritus, Injection site rash, Pain in extremity
Clinical narrative: 2/1/21  sore arm 2/2/21  sore arm and itchy rash at site  2/3/21  sore arm and very itchy rash at site that became raised and redder 2/4/21  still have rash and soreness
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Pharyngeal swelling, Swelling face
Clinical narrative: Approximately, 10 minutes after completing her 15 minute observation, the patient returned to report swelling of the throat, face, and lips. She was given 10ml of liquid Benadryl. BP: 118/78, P: 70, R: 16, T: 99.2F. Ten minutes after administering Benadryl, the patient reported returned sensation of lips and reduced swelling observed in face. Patient denied return or increasing symptoms post Benadryl. She was monitored for 1 hr post initial complaint and released after symptoms improved.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Pain, Pain in extremity
Clinical narrative: Patient called pharmacy around 9:15 am complaining about  side effect after receiving Moderna  Covid 19 vaccine 2nd dose. Patient was advised to see doctor immediately. Patient stated that he didn't had any reaction after getting first dose of Moderna Covid 19 Vaccine (Lot - 027L20A - Site : LD - IM) on 01/05/2021.  As per patient, on Wednesday 02/03/2021 around 3 am woke up with high fever( 102.7), chills, body sore, joint muscle pain and feeling tired.  On Thursday 02/04/2021 around 2 am had fever (99.7), leg pain, low back pain  and swelling in left armpit. Has appointment with physician at 10:45am.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Swelling
Clinical narrative: Patient called pharmacy around 9:15 am complaining about  side effect after receiving Moderna  Covid 19 vaccine 2nd dose. Patient was advised to see doctor immediately. Patient stated that he didn't had any reaction after getting first dose of Moderna Covid 19 Vaccine (Lot - 027L20A - Site : LD - IM) on 01/05/2021.  As per patient, on Wednesday 02/03/2021 around 3 am woke up with high fever( 102.7), chills, body sore, joint muscle pain and feeling tired.  On Thursday 02/04/2021 around 2 am had fever (99.7), leg pain, low back pain  and swelling in left armpit. Has appointment with physician at 10:45am.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Seizure
Clinical narrative: On 2-3-21 at 8:30a, he had a 1 minute seizure.  He also had a fever of 101.3F.  The temp responded to Tylenol.  He did have another seizure at 12:05p for 1 minute. He continued to require medication for fever thru 12:15am on 2-4-21.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: pain, swelling, redness at injection site headache
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: I tested positive for Covid, got exposed by my sister in law.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: @Around 6pm 2/3/2021 I got severe chills and body aches, I felt feverish but didnt have a thermometer to confirm temp
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Malaise, Pyrexia
Clinical narrative: Headache Fever, chills, malaise, fatigue Narrative:
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Dry mouth, Fatigue, Lethargy, Myalgia
Clinical narrative: Lethargy, fatigue, dry mouth, muscle aches
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Heart rate irregular, Myalgia, Pyrexia
Clinical narrative: I began to have fever, chills, muscle aches, joint aches, and rapid heartbeat.  They lasted approximately 36 hours.
Age: 75.0
Sex: F
Vaccine: UNK
Symptoms: Chills, Dizziness, Feeling cold, Headache, Lethargy
Clinical narrative: sore throat and neck followed by muscle aches, slight headache, lethargy, lightheadedness when getting up,  later cold and chills around 5 or 6 pm.  I went to bed around 10 pm and awoke around 5:30 am feeling just fine. I took no medications other than my insulin and prescribed meds for that day.
Age: 75.0
Sex: F
Vaccine: UNK
Symptoms: Myalgia, Neck pain, Oropharyngeal pain
Clinical narrative: sore throat and neck followed by muscle aches, slight headache, lethargy, lightheadedness when getting up,  later cold and chills around 5 or 6 pm.  I went to bed around 10 pm and awoke around 5:30 am feeling just fine. I took no medications other than my insulin and prescribed meds for that day.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Hypoaesthesia, Muscle spasms
Clinical narrative: 48 hours after receiving vaccine patient awoke with left foot cramping sensation Withing another 24 hours her entire left leg was numb She took advil for 5 days with no relief and then began having severe lower back pain - dull, aching to sharp She was started on a medrol dose pak and she had relief from left foot cramping and leg numbness but at end of steroid pack she is still having lower back pain
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Vaccine positive rechallenge
Clinical narrative: Rash all over developed 2 hours after vaccination received.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Pain, Rash
Clinical narrative: Shingles in left thigh radiating to left lower abdomen two days after vaccine Went to Urgent care 2 days after pain/rash started Treated with Acyclovir for 1 week 10 days later, rash improved. Pain continues, somewhat improved.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Joint range of motion decreased, Pain, Vaccination site pain
Clinical narrative: Severe soreness in my arm in and around the site of the vaccine within a few hours of the injections to the point of not being able to move my arm without pain.  Itching at the site of the injection started two days after and continued for 10 days.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Head discomfort, Nasopharyngitis, Pain in extremity
Clinical narrative: arm soreness, RT side of head towards back  at curve and top of head soft spot area cold heavy sensation
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Injection site swelling, Injection site warmth, Malaise
Clinical narrative: Moderna Covid 19 Vaccine. Pt reported that she felt sick 2 days after her first shot. She had joint paint, fatigue, was very tired, the area of the injection was hot and a little swollen about 2 inches wide. She took 2 benadryls which seem to help a little. She will start taking Claritin during the day and Benadryl at night for next few days to see if any improvement. She will draw along the perimeter of the affected area and check it daily to see if any improvement and will call her MD if fever occurs
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Malaise, Myalgia, Pyrexia
Clinical narrative: Muscle aches, weakness, feverish, general malaise
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness
Clinical narrative: Patient passed out after receiving vaccine.  She regained consciousness without any intervention.  She reports she frequently passes out after vaccinations.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Vaginal haemorrhage
Clinical narrative: experienced vaginal spotting started at approximately 12:10 PM and continued until 11PM. Approximately 5 weeks pregnant at time of injection, estimated due date 10/07/2021.
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Antibody test negative, Measles antibody negative, Mumps antibody test negative, Rubella antibody negative
Clinical narrative: Measles antibody negative; Mumps antibody test negative; Rubella antibody negative; Antibody test negative; This spontaneous report as received from a pharmacist referring to a female patient of unknown age. Information regarding the patient's concurrent conditions, medical history and historical drugs  was not provided.       In January 2020, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) for prophylaxis (strength, dose, frequency, route of administration, lot number and expiration date were not reported).  In February 2020, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) for prophylaxis (strength, dose, frequency, route of administration,lot number and expiration date were not reported). Concomitant therapies included the sterile diluent.     The patient reported that when she got the blood test done, it did not show any antibodies to both of these vaccines (measles antibody negative, antibody test negative, rubella antibody negative and mumps antibody test negative) therefore, the reporter would like to know if this patient should be revaccinated. The outcome of measles antibody negative, antibody test negative, rubella antibody negative and mumps antibody test negative was unknown.      The causal relationship between measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and  varicella virus vaccine live (oka/merck) (VARIVAX) and the reported events was unknown.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia
Clinical narrative: post herpetic neuralgia; multiple outbreaks of herpes zoster; This spontaneous report was received from a lawyer referring to a currently 65 year-old patient of unknown gender. The patient's relevant medical history, drug reactions/allergies and concomitant medication were not reported. On or about 11-JUN-2016, the patient was vaccinated with zoster vaccine live(ZOSTAVAX) for long-term prevention of shingles and zoster-related conditions. (strength, route, dosage schedule, lot number and expiration date were not reported).       On an unknown date, the patient was treated by providers for the following injuries resulting from zoster vaccine live(ZOSTAVAX) vaccination: multiple outbreaks of herpes zoster and post herpetic neuralgia.     The outcome of post herpetic neuralgia and herpes zoster was unknown.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache since date of second dose
Sex: F
Vaccine: VARZOS
Symptoms: Autoimmune disorder
Clinical narrative: The reaction involved her developing 3 autoimmune disorders in 2011; This spontaneous report was received from a consumer regarding to herself;  a female patient of unknown age.    Information regarding the patient's  concomitant therapies, concurrent conditions, medical history and historical drugs was not provided.  On an unknown date in 2009,  the patient was vaccinated with zoster vaccine live(ZOSTAVAX) for prophylaxis (strength, dose, frequency, route of administration, lot number and expiration date were not reported).  On an unknown date in 2011, the patient experienced 3 autoimmune disorders.  The outcome of autoimmune disorder was unknown.    The reporter considered autoimmune disorder to be related to Zoster Vaccine Live(ZOSTAVAX).     Upon internal review, the autoimmune disorder event was determined to be medically significant.
Sex: U
Vaccine: HEPA, DTAPHEPBIP, FLU4, HEPA, HIBV, MMR, PNC13
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Expired vaccine used; This spontaneous report was received from a consumer of unknown age and gender referring her/himself. Information about patient's pertinent concurrent conditions, medical history and concomitant medications was not provided.  On 19-JAN-2021, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated(VAQTA) as prophylaxis (concentration, vaccination scheme frequency, dosage, route of administration and anatomical location, lot number and expiration date were not reported) (experienced expired product administered). No additional adverse event was involved.
Sex: U
Vaccine: HEPA, DTAPHEPBIP, FLU4, HEPA, HIBV, MMR, PNC13
Symptoms: Expired product administered
Clinical narrative: No adverse event; Expired vaccine used; This spontaneous report was received from a consumer of unknown age and gender referring her/himself. Information about patient's pertinent concurrent conditions, medical history and concomitant medications was not provided.  On 19-JAN-2021, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated(VAQTA) as prophylaxis (concentration, vaccination scheme frequency, dosage, route of administration and anatomical location, lot number and expiration date were not reported) (experienced expired product administered). No additional adverse event was involved.
Sex: U
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: that an improperly stored vaccine was administered on 25-JAN-2021 to a patient; This spontaneous report was received from a registered nurse and refers to a patient of unknow age and gender. There was no information about patient's concomitant medications, concurrent conditions or pertinent medical history.  On 25-JAN-2021, the patient was vaccinated with the first dose of with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot number T026954 with expiration date 13-APR-2022 (dose, route and anatomical location were not reported) which was improperly stored as prophylaxis. The hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was exposed to temperature above 9 Fahrenheit (13.4 Celsius degrees) during 2 hours and 9 minutes. There was no previous temperature excursion and data digital logger was filled.
Sex: M
Vaccine: HPV9
Symptoms: Pain
Clinical narrative: he was sore after the shots; The nurse reported that he got 14 shots all on the same day; This spontaneous report was received from a registered nurse and refers to an 18-year-old male patient. There was no information about patient's concomitant medications, concurrent conditions or pertinent medical history.  On an unknown date, the patient went to the clinic for vaccines because his family did not believe in vaccinating as a child. The patient got 14 shots all on the same day. He was vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (dose, route, anatomical location, lot number and expiration date were not reported) for prophylaxis.  On an unknown date, the patient was sored (pain) after the shots.  At the time of the report, the outcome of the event was unknown.  The relatedness between the event of pain and therapy with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was not reported.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Hepatic enzyme increased
Clinical narrative: Fatigue, elevated liver enzymes 3x the normal.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No further adverse event (AE) details; Proquad was stored in the refrigerator instead of the freezer since 01-DEC-2020; This spontaneous report has been received from a nurse regarding to a patient of unknown age and gender. There was no information provided about the patient's concurrent conditions, concomitant therapies, historical drugs, drug reactions or allergies, or pertinent medical history.  On 28-JAN-2021, the patient was vaccinated with an improperly stored dose (stored in the refrigerator instead of the freezer since 01-DEC-2020) of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live  (PROQUAD) injection, at a dose of 0.5 milliliters (mL), lot number reported and validated as T025221, expiration date reported and validated as 19-JAN-2022, (strength, route of administration, anatomical site of vaccination, and vaccination scheme frequency were not reported) (product storage error) and on an unknown date, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) injection, at a dose of 0.5 mL (strength, route of administration, anatomical site of vaccination, vaccination scheme frequency, lot number, and expiration date were not reported) both as prophylaxis.   It was reported that Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) was stored at a temperature of 44 Fahrenheit degree (F) for the time frame of 1506 hours. There was no previous temperature excursion and the call was not due to a data logger.  No adverse effects reported.
Sex: U
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: This is a request to ask the FDA to encourage the scientific community to pursue an ETHICAL Covid-19 vaccine that does NOT use the fetal line of aborted children in either the production or testing of a vaccine!! Many of us have a conscientious objection to the use of aborted children in this manner and will not participate in this unethical use of human beings.
Sex: F
Vaccine: COVID19
Symptoms: Transient ischaemic attack
Clinical narrative: Transient ischemic attack; A report was received from a consumer concerning a 50 year old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and developed a TIA (Transient ischemic attack).   The patient's medical history was not provided. The patient current condition included ulcerative colitis, blood pressure, cholesterol and acid reflux. No relevant concomitant medications were reported.   On 29 Dec 2020, approximately twelve days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot number 026L20A) intramuscularly for prophylaxis of COVID-19 infection.   The patient experienced a TIA on 10 Jan 2021. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not provided .   The outcome of the event TIA was unknown.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Fatigue, Injection site erythema, Injection site induration
Clinical narrative: My upper arm swelled. The site turned red and I now have a hardened, red area about the size of an egg. I also developed severe chills, fatigue, insomnia, diarrhea about 12 hours after receiving the injection. The symptoms improved after approximately 24 hours. I am still fatigued and my arm is no longer swollen other than the area the size of an egg.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Insomnia
Clinical narrative: My upper arm swelled. The site turned red and I now have a hardened, red area about the size of an egg. I also developed severe chills, fatigue, insomnia, diarrhea about 12 hours after receiving the injection. The symptoms improved after approximately 24 hours. I am still fatigued and my arm is no longer swollen other than the area the size of an egg.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Hypertension, Transient ischaemic attack
Clinical narrative: Ischemic attack; Severe high blood pressure; A spontaneous report was received from a consumer concerning a 77-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced severe high blood pressure (BP) and ischemic attack.  The patient's medical history included diabetes. Products known to have been used by the patient, within two weeks prior to the event, included atorvastatin calcium, bupropion hydrochloride, gabapentin, ibuprofen, estradiol and metformin.  On 08 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 027L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.    On 12 Jan 2021, the patient was taken by ambulance to the hospital with severe high BP. During her hospital stay the patient's BP readings were 190s/109. The patient was diagnosed with ischemic attack.  On 14 Jan 2021, the patient was discharged from the hospital. Her BP readings since then have been 179/85.   On 19 Jan 2021, the patient's BP reading was 145/80.   Treatment for the event included lisinopril.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.    The outcome of the events, severe high BP and ischemic attack, was considered unknown.; Reporter's Comments: This case concerns a 77-year-old female patient with medical history of diabetes who experienced the serious unlisted events of Hypertension and Transient ischaemic attack that required hospitalization. The events occurred approximately four days after receiving their first of two planned doses of mRNA-1273 (Lot number: 027L20A), Based on the current available information and temporal association between the use of the product and the onset of the events, a causal relationship cannot be excluded and the events are considered possibly related to the vaccine. Of note, patient's elderly age and history of diabetes are considered risk factors for the occurrence of the events.