chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Syringe issue, Underdose
Clinical narrative: The following information was documented by the employee: "Syringe came apart during injection of covid vaccine - needle was in arm and I was pushing plunger down when syringe shaft separated from needle. Vaccine sprayed out. Needle was still in arm with orange connecting hub. Some vaccine was likely administered but definitely not the whole dose. Needle removed from arm without difficulty and placed in sharps container. Name of needle: "Needle Retractable Safety Syringe, Guangdong Haiou Medical Apparatus Co. Lot 20IB0"
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Hypoaesthesia, Pain in extremity, Paraesthesia, Paraesthesia oral
Clinical narrative: I had a sore arm a couple hours later.  Approximately 2- 2 1/2 hours after the injection the right side of my face started tingling, not completely numb but mild numbness.  The feeling is similar to Novacane wearing off from dental work.  Around 8 p.m. while laying down, my lips tingled for awhile.  As on 10 a.m. on 2/12/2021 I still have mild tingling in my right side of face and upper lip area on the right side.  I have had mild chills.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus, Rash macular
Clinical narrative: Moderna - Manufacturer  Total body involved - red splotches - very much itching.  Took Benadryl 25mg with Pepcid 20mg, splotches and itching subsided for remainder of the day.  Reoccurred again the next morning. Spoke to health dept. nurse and reported reaction then next morning had phone visit with primary care physician who prescribed the same protocol (I am a retired nurse) that I had administered, told to repeat,  Symptoms dissipated by recurred periodically throughout the week, not too much discomfort until wee hours of 2/12 where it has "recycled" and affected my entire body.  Repeated Benadryl/Pepcid to relieve the itching and redness has diminished somewhat as of 10:00am but I need to know if the will continue and what should be my next step for treatment.  Obviously as antibodies continue to build, there is something in this vaccine my system does NOT like.  I have a terminally ill son and I can not continue to fight this for the unforeseen future.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Chapped lips, Oral mucosal erythema
Clinical narrative: Redness around mouth and cracked lips experienced for more than 3 weeks,  Similar symptoms recurring after the 2nd dose of COVID-19 Moderna vaccine 010M20A
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Electrocardiogram, Nausea, Palpitations
Clinical narrative: Moderna COVID-19 Vaccine EUA. Nause, dizziness/weakness and palpitations about 5 minutes after received the second dose.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Injection site erythema, Injection site pruritus, Oropharyngeal discomfort, Rash
Clinical narrative: On Wednesday on the 10th when I woke up I had a rash on both of my forearms. A couple of hours later I looked at it and it disappeared. Then I looked at my right arm where I got the shot and at the injection site, there is a like red spots in the circle (looked like chicken pox). When I woke up on Thursday when I woke up it spread from a circle to a rectangle shape and completely filled in with some little red spots. It has been itching. Yesterday I spoke with my doctor and they said to take some Benadryl and put ice on it and that is was okay to put Corizatone 10 cream on it.  My doctor said if it spread to call them back. I did not have Benadryl yesterday so I started taking it this morning. It appeared lighter in color after putting the cream on it. I got up early this morning and it disappeared and when I woke up this morning it was back again. This has been going on and off for the last couple of days I have had a slight cough and scratchy throat. For the last couple of weeks I have had a runny nose and been sneezing on and off this I think it connected to my allergies.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea, Sneezing
Clinical narrative: On Wednesday on the 10th when I woke up I had a rash on both of my forearms. A couple of hours later I looked at it and it disappeared. Then I looked at my right arm where I got the shot and at the injection site, there is a like red spots in the circle (looked like chicken pox). When I woke up on Thursday when I woke up it spread from a circle to a rectangle shape and completely filled in with some little red spots. It has been itching. Yesterday I spoke with my doctor and they said to take some Benadryl and put ice on it and that is was okay to put Corizatone 10 cream on it.  My doctor said if it spread to call them back. I did not have Benadryl yesterday so I started taking it this morning. It appeared lighter in color after putting the cream on it. I got up early this morning and it disappeared and when I woke up this morning it was back again. This has been going on and off for the last couple of days I have had a slight cough and scratchy throat. For the last couple of weeks I have had a runny nose and been sneezing on and off this I think it connected to my allergies.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: Sudden onset fever, chills and terrible headache. Lasting at least 2 days
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain
Clinical narrative: Aches, chills, headache, yucky
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Injection site erythema, Injection site pain
Clinical narrative: Headache onset within 2 hours of injection.  Redness/Tenderness to injection site within 4 hours (approx 3 in diameter).  Fever, chills and body aches along with redness and rash to entire upper arm with hard bump and warm to touch onset within 12 hours.  Fever, chills and body aches lasted 48 hours,  Redness and rash beginning to improve after 48 hours.  Fatigue and muscle aches continue.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain, Pyrexia, Rash, Rash erythematous
Clinical narrative: Headache onset within 2 hours of injection.  Redness/Tenderness to injection site within 4 hours (approx 3 in diameter).  Fever, chills and body aches along with redness and rash to entire upper arm with hard bump and warm to touch onset within 12 hours.  Fever, chills and body aches lasted 48 hours,  Redness and rash beginning to improve after 48 hours.  Fatigue and muscle aches continue.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Skin induration, Skin mass, Skin warm
Clinical narrative: Headache onset within 2 hours of injection.  Redness/Tenderness to injection site within 4 hours (approx 3 in diameter).  Fever, chills and body aches along with redness and rash to entire upper arm with hard bump and warm to touch onset within 12 hours.  Fever, chills and body aches lasted 48 hours,  Redness and rash beginning to improve after 48 hours.  Fatigue and muscle aches continue.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Diarrhoea, Feeling cold, Flatulence
Clinical narrative: Tues: sore arm, sore glands in neck, hurt to turn.    Thurs. 2 am.started with Stomach cramps and diahrea also chills . Fri. Am stomach still not feeling great. Some cramping and gas and a little nausea. Feel cold
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Nausea, Neck pain, Pain in extremity
Clinical narrative: Tues: sore arm, sore glands in neck, hurt to turn.    Thurs. 2 am.started with Stomach cramps and diahrea also chills . Fri. Am stomach still not feeling great. Some cramping and gas and a little nausea. Feel cold
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Abdominal pain, Axillary mass, Breast tenderness, Chills
Clinical narrative: Received vaccine #2 in rt deltoid at 10:30 AM Day 1: 1/27/21 (Wednesday) began to have whale sounds/gas and pain in lower abdomen in GI tract, then explosive diarrhea about 6 hours post Vaccine #2, Had chills and fever throughout the night; at 24 hours post vaccine developed a baseball sized swollen hard area to right axilla, very painful. Injection site swelling. and warm to touch, Symptoms continued through Sunday then area under axilla had reduced but right breast was bright pink and tender to touch, lymph nodes/glands on right side of jawline swelled and right ear became blocked and painful. I had some antibiotics for prophylaxis that I began to take 2/10/2021 and now area at jawline is improving and ear pain is improving. Teeth on right side at back feel like there is extreme pressure there. On 2/8/21 began having vision issue in left eye and pain in back right occipital area. took 2 baby aspirin and issue resolved. Experiencing nerve tingling in left side of face and lip all week. Comes and goes. Still having diarrhea and lower GI issues.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Ear discomfort, Ear pain, Echocardiogram, Erythema
Clinical narrative: Received vaccine #2 in rt deltoid at 10:30 AM Day 1: 1/27/21 (Wednesday) began to have whale sounds/gas and pain in lower abdomen in GI tract, then explosive diarrhea about 6 hours post Vaccine #2, Had chills and fever throughout the night; at 24 hours post vaccine developed a baseball sized swollen hard area to right axilla, very painful. Injection site swelling. and warm to touch, Symptoms continued through Sunday then area under axilla had reduced but right breast was bright pink and tender to touch, lymph nodes/glands on right side of jawline swelled and right ear became blocked and painful. I had some antibiotics for prophylaxis that I began to take 2/10/2021 and now area at jawline is improving and ear pain is improving. Teeth on right side at back feel like there is extreme pressure there. On 2/8/21 began having vision issue in left eye and pain in back right occipital area. took 2 baby aspirin and issue resolved. Experiencing nerve tingling in left side of face and lip all week. Comes and goes. Still having diarrhea and lower GI issues.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hyperaesthesia teeth, Induration, Injection site swelling, Injection site warmth
Clinical narrative: Received vaccine #2 in rt deltoid at 10:30 AM Day 1: 1/27/21 (Wednesday) began to have whale sounds/gas and pain in lower abdomen in GI tract, then explosive diarrhea about 6 hours post Vaccine #2, Had chills and fever throughout the night; at 24 hours post vaccine developed a baseball sized swollen hard area to right axilla, very painful. Injection site swelling. and warm to touch, Symptoms continued through Sunday then area under axilla had reduced but right breast was bright pink and tender to touch, lymph nodes/glands on right side of jawline swelled and right ear became blocked and painful. I had some antibiotics for prophylaxis that I began to take 2/10/2021 and now area at jawline is improving and ear pain is improving. Teeth on right side at back feel like there is extreme pressure there. On 2/8/21 began having vision issue in left eye and pain in back right occipital area. took 2 baby aspirin and issue resolved. Experiencing nerve tingling in left side of face and lip all week. Comes and goes. Still having diarrhea and lower GI issues.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain in extremity, Paraesthesia, Paraesthesia oral, Pyrexia
Clinical narrative: Received vaccine #2 in rt deltoid at 10:30 AM Day 1: 1/27/21 (Wednesday) began to have whale sounds/gas and pain in lower abdomen in GI tract, then explosive diarrhea about 6 hours post Vaccine #2, Had chills and fever throughout the night; at 24 hours post vaccine developed a baseball sized swollen hard area to right axilla, very painful. Injection site swelling. and warm to touch, Symptoms continued through Sunday then area under axilla had reduced but right breast was bright pink and tender to touch, lymph nodes/glands on right side of jawline swelled and right ear became blocked and painful. I had some antibiotics for prophylaxis that I began to take 2/10/2021 and now area at jawline is improving and ear pain is improving. Teeth on right side at back feel like there is extreme pressure there. On 2/8/21 began having vision issue in left eye and pain in back right occipital area. took 2 baby aspirin and issue resolved. Experiencing nerve tingling in left side of face and lip all week. Comes and goes. Still having diarrhea and lower GI issues.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling, Visual impairment
Clinical narrative: Received vaccine #2 in rt deltoid at 10:30 AM Day 1: 1/27/21 (Wednesday) began to have whale sounds/gas and pain in lower abdomen in GI tract, then explosive diarrhea about 6 hours post Vaccine #2, Had chills and fever throughout the night; at 24 hours post vaccine developed a baseball sized swollen hard area to right axilla, very painful. Injection site swelling. and warm to touch, Symptoms continued through Sunday then area under axilla had reduced but right breast was bright pink and tender to touch, lymph nodes/glands on right side of jawline swelled and right ear became blocked and painful. I had some antibiotics for prophylaxis that I began to take 2/10/2021 and now area at jawline is improving and ear pain is improving. Teeth on right side at back feel like there is extreme pressure there. On 2/8/21 began having vision issue in left eye and pain in back right occipital area. took 2 baby aspirin and issue resolved. Experiencing nerve tingling in left side of face and lip all week. Comes and goes. Still having diarrhea and lower GI issues.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Chills, Dizziness, Facial pain, Fatigue
Clinical narrative: 12:30 am 2/11/2021; fever, chills, all over body aches, severe fatigue, sharp pains from injection site down arm, legs, across chest and face. Lasted until approximately 5 am on 2/12/2021. 2/12/2021 at 6am; Foginess, forgetfulness, light headedness, still ongoing but resolving. Tylenol and ibuprofen for treatment-effective except for the forgetfulnees/foggy feeling
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Injection site pain, Memory impairment, Pain, Pain in extremity
Clinical narrative: 12:30 am 2/11/2021; fever, chills, all over body aches, severe fatigue, sharp pains from injection site down arm, legs, across chest and face. Lasted until approximately 5 am on 2/12/2021. 2/12/2021 at 6am; Foginess, forgetfulness, light headedness, still ongoing but resolving. Tylenol and ibuprofen for treatment-effective except for the forgetfulnees/foggy feeling
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: 12:30 am 2/11/2021; fever, chills, all over body aches, severe fatigue, sharp pains from injection site down arm, legs, across chest and face. Lasted until approximately 5 am on 2/12/2021. 2/12/2021 at 6am; Foginess, forgetfulness, light headedness, still ongoing but resolving. Tylenol and ibuprofen for treatment-effective except for the forgetfulnees/foggy feeling
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Flatulence, Pain, Pyrexia
Clinical narrative: Achy whole body, abdominal area bloated/gas filled, fever of 101 deg (normal temperature runs 97.x) Lasted 2 1/2 days
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Injection site pain, Nausea
Clinical narrative: Pfizer-BioNTech COVID-19 Vaccine EUA injection site pain headache nausea
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chest discomfort, Mobility decreased, Pain, Swelling
Clinical narrative: Patient reports she developed pain, swelling and decreased range of motion the day after getting the vaccine. She reports it lasted several days after. She has been taking Tylenol and prescription NSAID daily to ease the pain. The prescription is actually for her knees but she states she has been taking it to relieve the pain in her right shoulder. She reports now (16 days after vaccine) her range of motion has returned but she still has discomfort to pectoral and deltoid area when doing a "rowing" motion.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Influenza, Pyrexia
Clinical narrative: flu symptom. No appetite, fever, chills.  Lasted 48 hours
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Renal pain, Urinary tract pain
Clinical narrative: Within 30 I experienced accuse pain in my urinary track from my prostate to my left kidney.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Lymphadenopathy, Paraesthesia
Clinical narrative: Lymphadenopathy - painful swelling in the L axillary lymph node that started 5 days after the 1st dose and lasted for a little longer than 24 hours. There was extending tingling in the L breast area which also started and stopped with the lymph node swelling.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Injection site pain, Injection site pruritus, Pain of skin, Pruritus
Clinical narrative: My arm started getting red and itchy on the second day.  I had a red circle a little bigger than a silver dollar that was hot, hard and stinging and itchy for about 3 weeks after the injection.  Today my arm is better but it is still not completely gone.  My arm still itches and burns at the injection site.  I did not run a fever or feel really bad.   I don't know if this event was related to the vaccine or not but about 3 days after getting the vaccine, my tongue started burning like when you eat to many nuts or salty snacks and it was only on the left side of my tongue.  My left check also was itchy.  That resolved after about a week.  I have had in the past a similar situation that I have called burning tongue/
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Skin induration, Skin warm, Tongue discomfort
Clinical narrative: My arm started getting red and itchy on the second day.  I had a red circle a little bigger than a silver dollar that was hot, hard and stinging and itchy for about 3 weeks after the injection.  Today my arm is better but it is still not completely gone.  My arm still itches and burns at the injection site.  I did not run a fever or feel really bad.   I don't know if this event was related to the vaccine or not but about 3 days after getting the vaccine, my tongue started burning like when you eat to many nuts or salty snacks and it was only on the left side of my tongue.  My left check also was itchy.  That resolved after about a week.  I have had in the past a similar situation that I have called burning tongue/
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: Injection Site/muscle pain. Still there but not as bad today.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site induration, Injection site pain, Injection site papule, Injection site pruritus, Injection site swelling
Clinical narrative: Injection site was initially sore for two days and then pain became minimal. Today I awoke to find my injection site raised, bumpy, hot to the touch, and very itchy. Today is day 8 following my injection.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site warmth
Clinical narrative: Injection site was initially sore for two days and then pain became minimal. Today I awoke to find my injection site raised, bumpy, hot to the touch, and very itchy. Today is day 8 following my injection.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia oral, Pharyngeal paraesthesia
Clinical narrative: Pt c/o tingling sensation of tongue and throat after receiving 2nd vaccine dose. No facial edema or difficulty swallowing or breathing. States this also happened with the first dose and it lasted 4-5 days. She only reported that episode to her pcp who advised her to premedicate with Benadryl for 2nd dose which she did. Facility gave her an additional Benadryl 12.5 mg and monitored for 60 min without any worsening symptoms. Called pt next day and symptoms had improved somewhat. Denied facial swelling, difficulty swallowing or breathing .Advised to follow up with her pcp or call 911 if swelling or difficulty breathing occurred.
Age: 64.0
Sex: F
Vaccine: UNK
Symptoms: SARS-CoV-2 test negative, Streptococcus test negative, Unevaluable event
Clinical narrative: Moderna COVID 19 Vaccine EUA
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Rash
Clinical narrative: Patient developed rash and also lymphadenopathy, supraclavicular after injection with 2nd dose of moderna covid vaccine
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Injection site erythema, Injection site reaction, Injection site warmth, Pain
Clinical narrative: Nine days post vaccine, injection site has large (approx. 2x3 inches oval) red welp.  Shoulder, arm, upper back is weak, warm, and achy.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Nine days post vaccine, injection site has large (approx. 2x3 inches oval) red welp.  Shoulder, arm, upper back is weak, warm, and achy.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: Continued headache and fatigue 8 days after vaccine administration.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia, Pyrexia
Clinical narrative: fever, muscle aches, fatigue, headache.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: Same crap I had first shot, check your records
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: Injection just before noon on Tuesday. Very tired that night after the injection. Starting at 0300 the following morning, had hard shaking chills. Fever got as high as 103.8. Generalized aches, bad headache. Fever finally broke Thursday afternoon.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Hypoaesthesia, Lacrimation increased, Pain in jaw, Paraesthesia
Clinical narrative: Left side of face started going numb and tingling, jaw hurt and felt still, began rapid breathing and had watery eyes, then left side of body had less sensation
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Respiratory rate increased
Clinical narrative: Left side of face started going numb and tingling, jaw hurt and felt still, began rapid breathing and had watery eyes, then left side of body had less sensation
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Systemic: Other- Patient died - cause unknown; 1 day
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Blood creatinine, Blood electrolytes normal, Chest X-ray normal, Condition aggravated
Clinical narrative: 75 year old M, worsening weakness for the past several weeks.  Seems to have gotten worse since Monday when he had his first Covid vaccine here at the hospital.  Denies any headaches or neck pain.  No fevers or chills.  No cough or shortness of breath.  No abdominal pain.  No vomiting or diarrhea.  No black or bloody stools.  No dizziness.  Today he almost fell and the son had to catch him.  He did not suffer any trauma.  He offers no symptoms of pain.  Here he is fully awake and alert.  Nothing to clinically suspect a stroke.  His vitals are stable.  Chest x-ray shows nothing acute.  Creatinine is better than baseline.  Electrolytes are stable.  Troponin reassuring.  He had no chest pain or shortness of breath to suspect angina.  Spoke to the wife via telephone, he is getting so weak that he was unable to walk.  Paramedics report they had lift him as he could not take a step.  He was unable to ambulate here in the emergency room.  At this time it does not seem like I can safely discharge him home.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Gait disturbance, Gait inability, Troponin
Clinical narrative: 75 year old M, worsening weakness for the past several weeks.  Seems to have gotten worse since Monday when he had his first Covid vaccine here at the hospital.  Denies any headaches or neck pain.  No fevers or chills.  No cough or shortness of breath.  No abdominal pain.  No vomiting or diarrhea.  No black or bloody stools.  No dizziness.  Today he almost fell and the son had to catch him.  He did not suffer any trauma.  He offers no symptoms of pain.  Here he is fully awake and alert.  Nothing to clinically suspect a stroke.  His vitals are stable.  Chest x-ray shows nothing acute.  Creatinine is better than baseline.  Electrolytes are stable.  Troponin reassuring.  He had no chest pain or shortness of breath to suspect angina.  Spoke to the wife via telephone, he is getting so weak that he was unable to walk.  Paramedics report they had lift him as he could not take a step.  He was unable to ambulate here in the emergency room.  At this time it does not seem like I can safely discharge him home.
Age: 28.0
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy, Incomplete course of vaccination
Clinical narrative: No other details provided; She took the product while pregnant; This spontaneous, prospective pregnancy report was received from a consumer and refers to herself, a 28-year-old, female patient. She had no pertinent medical history, no concomitant medications, drug reactions or allergies.   On 09-DEC-2020, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection, first dose of two scheduled doses (exact dose, strength, exact route of administration, anatomical location, lot # and expiration date were unknown) for lack of antibodies. The patient stated, that she took the vaccine after getting pregnant and at the administration time she did not know that she was pregnant (exposure during pregnancy). The patient wanted to know, if the vaccination would affect her pregnancy, although she did not search medical attention. The last menstrual period (LMP) was on approximately unknown date in 2020. The estimated delivery date (EDD) or gestational period were not provided. The pregnancy outcome was pending (unknown fetal outcome). The therapy was reported as discontinued on 13-JAN-2021, as the patient took only one of the two scheduled injections. No adverse event was reported.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered
Clinical narrative: expired dose of Pneumovax 23 was administered to a patient; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medication were not reported.   On 08-FEB-2021, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot # S005856 has been verified to be a valid lot number, expiration date was not reported, but upon internal validation, it was established as 03-DEC-2020, 0.5 ml administered intramuscularly for prophylaxis. The reporter confirmed that the vaccine has had no temperature excursions and has been stored according to the recommended temperature range. No other information provided. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.devicelotnumber: S005856; expirationdate: 03-DEC-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Infection, Injection site erythema, Pyrexia
Clinical narrative: Fever; arm red; arm red; required antibiotics; This case was reported by a consumer via other manufacturer and described the occurrence of fever in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced fever, injection site erythema, erythema of extremities and infection. The patient was treated with antibiotics nos (Antibiotics (Brand Names Not Known)). On an unknown date, the outcome of the fever, injection site erythema, erythema of extremities and infection were unknown.   It was unknown if the reporter considered the fever, injection site erythema, erythema of extremities and infection to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter was calling on behalf of someone else. The person received Shingrix in left arm. The reporter stated that, it was told on the news that if a person had an adverse event to other vaccines, that person should not receive Covid vaccine.  The reporter was calling for information as to whether this person should receive the Covid vaccine. The reporter wanted to know how she would know if the ingredients in Covid-19 vaccine and Shingrix vaccine were similar. The reporter was inquiring if it was accurate that someone who had an adverse event to any other vaccine should not take the Shingrix vaccine. The reporter mentioned a reaction to a previous Shingrix vaccine, on 1st occasion experienced redness on injection site and experienced fever and required antibiotics. The reporter consented to follow up. For the tolerance of 2nd dose, refer linked case US2020AMR249487.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR249487:2nd shot
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Pyrexia, Subcutaneous abscess
Clinical narrative: chills; fever; skin abscess and had to have an incision and drainage performed; This case was reported by a consumer via other manufacturer and described the occurrence of chills in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included decreased appetite, weight loss (lost 15 lbs), abscesses of skin, loss of energy, diarrhea and constipation. Previously administered products included Shingles vaccine. Concomitant products included lenvatinib mesilate (Lenvima).   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced chills, fever and skin abscess drainage. On an unknown date, the outcome of the chills, fever and skin abscess drainage were unknown.   It was unknown if the reporter considered the chills, fever and skin abscess drainage to be related to Shingrix.  Additional details were received as follows: The patient's spouse reported that patient received the lenvima 20 mg in past on 14th October 2020 for differentiated thyroid cancer. Patient had past history of skin abscesses. On unknown date patient received the shingles vaccine. Patient had lab tests in end of November such as CT scan which showed a reduction of 46 percent  in the size of his tumors. Patient's blood pressure was measured and it was going up a little bit but currently normal. Patient received the welcome kit and has been checking his blood pressure daily (diastolic usually in 80s, occasionally in 70s and twice at 90) Patient's appetite was decreased and he has lost 15 lbs since starting on Lenvima. On October 2020 patient had nutrition consult,also patient experienced overall lack of energy, diarrhea a couple of times, but mostly experienced constipation. On unknown date patient received the dose of Shingrix and on December 2020 patient experienced chills and fever with skin abscess and which had to have an incision and drainage performed along with Antibiotics. The reporter consented to follow up.
Sex: M
Vaccine: COVID19
Symptoms: Drug reaction with eosinophilia and systemic symptoms, Eosinophilia, Pyrexia, Rash
Clinical narrative: DRESS syndrome; Presistant fever; Rash; Eosinophilia; A spontaneous report was received from a physician concerning a male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and subsequently developed Drug reaction with eosinophilia and systemic symptoms (DRESS) syndrome.  The patient's medical history was not provided. Concomitant product use was not reported.     On 05 Jan 2021, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.    After vaccine administration, the patient subsequently developed persistent fevers, rash, and new eosinophilia.  The reporter stated being concerned for possible DRESS related to the vaccine. The patient was urgently referred to dermatology for a skin biopsy. No treatment information was provided.    Action taken with mRNA-1273 in response to the event was not provided.  The outcome of the event, DRESS, was unknown.; Reporter's Comments: This case concerns a male patient of unknown age who experienced a serious unexpected event of eosinophilia and systemic symptoms (DRESS) syndrome, including persistent fevers, rash, and new eosinophilia. The event occurred with unknown latency after first dose of mRNA-1273 on 05 Jan 2021. No further information available. Based on the current available information and temporal association between the use of mRNA-1273 and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: FLUX
Symptoms: Pain in extremity
Clinical narrative: arm was sore; Initial information received on 25-Jan-2021 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional.  This case involves a 77 year old female patient who had arm was sore (pain in extremity), while she received vaccine INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious arm was sore (pain in extremity) unknown latency following the administration of INFLUENZA VACCINE.  No laboratory data was provided.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome of event was unknown.  There will be no information available on the batch number for this case
Age: 0.58
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Product preparation issue
Clinical narrative: A patient received only the liquid portion of Pentacel without reconstituting, no AE; Initial information regarding an unsolicited valid non-serious case was received from a nurse via Regulatory Authority (Reference number- 00448757) and transmitted to Sanofi on 27-Jan-2021.  This case involves a seven-month-old male patient who received only the liquid portion of pentacel without reconstituting the Hib powder portion (product preparation issue), while he received DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR), ROTAVIRUS VACCINE (ROTAVIRUS VACCINE), INFLUENZA VACCINE INACT SPLIT 4V (FLUZONE QUADRIVALENT) and NA (sodium).  On 27-Jan-2021, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot U6890AA and expiry date: 08-Mar-2022) via an unknown route in right thigh for prophylactic vaccination.  This was a case of actual medication error due to inappropriate reconstitution technique (latency same day).  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nausea, Pyrexia
Clinical narrative: Nausea, Headache, 100.3° Fever, fatigue
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Electrocardiogram normal, Fatigue, Tunnel vision
Clinical narrative: I felt like I had tunnel vision, dizzy, wasn't functioning very well. I had fatigue as well.  I went to the ED for observation.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Angioedema, Dysphagia, Glossodynia, Nodule, Oedema peripheral
Clinical narrative: Received 2/2 COVID-19 vaccine 1/26/21 near 8:30 am. Shortly before 5 am the next morning (1/27) employee woke up & noticed tongue hurt, then discovered left unilateral tongue swelling and  was having difficulty speaking clearly. Employee was unable to find Benedryl at home & tongue was continuing to swell  and was having some difficulty swallowing so proceeded to ED. Employee also had 3 additional episodes of angioedema - 1st right upper and lower lip, 2nd left upper lip and 3rd right outer foot near heal and developed a 1/2 gumball size lump. Additional episodes occurred within 10 days after receiving the vaccination and all resolved with use of benadryl po and resolved within 24 hours.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Speech disorder, Swollen tongue
Clinical narrative: Received 2/2 COVID-19 vaccine 1/26/21 near 8:30 am. Shortly before 5 am the next morning (1/27) employee woke up & noticed tongue hurt, then discovered left unilateral tongue swelling and  was having difficulty speaking clearly. Employee was unable to find Benedryl at home & tongue was continuing to swell  and was having some difficulty swallowing so proceeded to ED. Employee also had 3 additional episodes of angioedema - 1st right upper and lower lip, 2nd left upper lip and 3rd right outer foot near heal and developed a 1/2 gumball size lump. Additional episodes occurred within 10 days after receiving the vaccination and all resolved with use of benadryl po and resolved within 24 hours.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: injection site and lower on the left arm.  Redness, swelling, soreness,  warm to touch  started 8 days after injection.   Day 9 redness is larger.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Developed severe shooting pain in L arm.  Unable to move arm.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Syringe issue, Underdose
Clinical narrative: The employee wrote: "Needle not screwed in tightly enough to syringe, some vaccine sprayed out when vaccine administered."
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site erythema, Injection site irritation, Injection site pain, Injection site pruritus
Clinical narrative: On the day of the injection 2/3/2021, the site was sore, red and swollen.  I also had a headache for 3-4 days afterwards.  The redness and swollen area went away.   Yesterday morning on 2/11/2021 (8 days after the injection) the injection site began to itch terribly.  Then the site turned red and irritated.  Last night, the site swelled and the red area and swollen area is the size of a baseball. It itches and is sore.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling
Clinical narrative: On the day of the injection 2/3/2021, the site was sore, red and swollen.  I also had a headache for 3-4 days afterwards.  The redness and swollen area went away.   Yesterday morning on 2/11/2021 (8 days after the injection) the injection site began to itch terribly.  Then the site turned red and irritated.  Last night, the site swelled and the red area and swollen area is the size of a baseball. It itches and is sore.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Injection site pain, Injection site swelling, Mobility decreased
Clinical narrative: SHOT WAS RECEIVED AT10:10AM ON FEBRUARY 10, 2021..  12:30 PM THE FIRST REACTION WAS DIZZINESS TO THE POINT THAT MOM COULD NOT GET UP ALONE.  NEXT SYMPTOM WAS SEVERE CHILLS.  PAIN SWELLING AT INJECTION SITE.  DAY TWO AFTER SHOT (FEB 11,2021) DIZZINESS CONTINUED AND SEVERE CHILLING.  FINGERS TURNED BLUEISH AND WERE EXTREMELY COLD.  MOM WAS ALSO NAUSEATED THE 2ND DAY AND KEPT A VOMIT BAG CLOSE TO HER.  AT NO POINT  DID SHE HAVE A FEVER.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Peripheral coldness, Skin discolouration
Clinical narrative: SHOT WAS RECEIVED AT10:10AM ON FEBRUARY 10, 2021..  12:30 PM THE FIRST REACTION WAS DIZZINESS TO THE POINT THAT MOM COULD NOT GET UP ALONE.  NEXT SYMPTOM WAS SEVERE CHILLS.  PAIN SWELLING AT INJECTION SITE.  DAY TWO AFTER SHOT (FEB 11,2021) DIZZINESS CONTINUED AND SEVERE CHILLING.  FINGERS TURNED BLUEISH AND WERE EXTREMELY COLD.  MOM WAS ALSO NAUSEATED THE 2ND DAY AND KEPT A VOMIT BAG CLOSE TO HER.  AT NO POINT  DID SHE HAVE A FEVER.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Blood test normal, Dysstasia, Mobility decreased
Clinical narrative: Patient stated that 2 days after receiving Moderna he had severe joint pain.  Could not lift arms above shoulders, make a fist, hard to stand after sitting.  He saw doctor beginning of following week and prescribed a round of prednisone.  I spoke with patient today and said that he is feeling better and strength is returning but, still weak.  Doctor told him to delay taking his 2nd dose of Moderna for 1 month.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever,
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain, Pain in extremity, Pyrexia
Clinical narrative: Sore arm, fever, body aches, head ache and fatigue
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure decreased, Dizziness, Heart rate decreased
Clinical narrative: Systemic: Other- blood pressure and heart rate dropped and patient was dizzy
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: Started itching and breaking out with hives all over body. Went to ER on 02/09/2021 and was given  a steroid shot. Was told by ER doctor to take antihistamine over the counter.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Headache, Injection site pain, Lymphadenopathy, Nausea
Clinical narrative: Pfizer BioNTech COVID-19 Vaccine EUA left armpit lymph node swelling injection site pain headache nausea joint pain
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Headache, Lymphadenopathy, Nausea, Vaccination site pain
Clinical narrative: Pfizer BioNTech COVID-19 Vaccine EUA left armpit lymph node swelling injection site pain headache nausea joint pain
Age: 87.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Oxygen saturation decreased, Pneumonia aspiration, Vomiting
Clinical narrative: On 1/26 at breakfast table began vomiting.  Continued thru am when at noon a caregiver did his O2 saturation and found it was 75%.  This was confirmed, and resent sent to ER .
Age: 87.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Aspiration, Death, Nausea, Vomiting
Clinical narrative: On 1/26 at breakfast table began vomiting.  Continued thru am when at noon a caregiver did his O2 saturation and found it was 75%.  This was confirmed, and resent sent to ER .
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Red, Swelling and itching at injection site about 2" in dia.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Night sweats, Pain
Clinical narrative: 2/10/21 10 :00pm - Body Aches started - night sweats - very tired throughout the night and next day - 2/11/21 9:00pm - All symptoms had stopped
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Vertigo
Clinical narrative: Persistent dizziness on getting out of bed followed by repeated dizzy spells every few minutes throughout the day.  Repeated spells lasting several seconds each throughout the entire day. Less frequent and less intense by evening. Resolved entirely by waking on following morning. No nausea, lightheadedness, or blood-rushing in ears experience. Just visual spinning.  No history of this symptom ever before. Or since.  No obvious correlation that was unusual or different in health or environment other than the vaccine earlier in that week.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Headache, Pain
Clinical narrative: body aches,headache,temperature,upset stomache.
Age: 94.0
Sex: M
Vaccine: COVID19
Symptoms: Haemorrhage, Scratch
Clinical narrative: Excessive bleeding from a small scratch, blood appeared very thin and did not want to clot
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Dry mouth, Dysgeusia, Dysphagia, Oropharyngeal pain, Pharyngeal swelling
Clinical narrative: About fifty minutes after shot I experienced a metallic taste in my mouth (my mouth was very dry), mild swelling in my throat, and mild difficulty swallowing.  The symptoms subsided after thirty minutes.  My throat was sore for two days.  I did not require medical attention.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Nausea, Pain, Pyrexia
Clinical narrative: nausea, temperature 101 controlled by Tylenol, body aches, chills, fatigue
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Blood pressure increased, Chest X-ray, Fall, Gait disturbance
Clinical narrative: 22 hours after injection; extreme weakness. Inability to stand, walk, rise from chair.  Fell to floor of home, lay there. Wife called 911. In ER: some fever and high B.P. discovered. IV. Chest x-ray. After 2-3 hours felt improved. Discharged after about 5 hours. Diagnosis: "Vaccine reaction. Fatigue." Slept normally. Feel well, normal now (10:00 a.m. 2/12/21)
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Injection related reaction, Mobility decreased, Pyrexia
Clinical narrative: 22 hours after injection; extreme weakness. Inability to stand, walk, rise from chair.  Fell to floor of home, lay there. Wife called 911. In ER: some fever and high B.P. discovered. IV. Chest x-ray. After 2-3 hours felt improved. Discharged after about 5 hours. Diagnosis: "Vaccine reaction. Fatigue." Slept normally. Feel well, normal now (10:00 a.m. 2/12/21)
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Abnormal faeces, Chills
Clinical narrative: pt states that she developed terrible stomach cramps, chills  and change in stools.  She says so far today she is no longer having the stomach cramps.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash
Clinical narrative: I developed a rash on my arm several inches below the injection site 12 days after the first dose of the vaccine.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Device connection issue
Clinical narrative: First Attempt- Inserted needle into arm, nurse said that the fluid didn't work getting injected into the arm. The needle and syringe weren't screwed together tightly enough and the vaccination liquid was dripping between the two. So we tried another shot as she was sure nothing ever got inside the shoulder.  Second Attempt -  To the patient, it was unclear if the second syringe was ever filled up with vaccination fluid or there was just an injection of the needle into the arm with no vaccine. (If there is an antibody test to check if the vaccine was administered correctly after these two errors, that would be preferred)
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Joint swelling, Malaise, Pruritus, Urticaria
Clinical narrative: beginning with itchy soles of my feet and both palms, and progressing through the day with the addition of grotesquely swollen knees and hives on legs, arms, and a few on my back. The hives presented as large welts all very itchy. I applied Calamine lotion and took a Loratadine pill, and the hives and itch subsided dramatically. I also developed flu-like symptoms of malaise and wheezing. At no time did I have a fever nor did my throat swell or close. Saturday, 24 hours after the first Loratadine pill, the hives and swelling reappeared but disappeared within 15 minutes of taking another Loratadine pill. Sunday through today, the swollen knees and wheeze remain but diminished in severity