chrisvoncsefalvay/vaers-outcomes huggingface dataset:
felt like she had the flu; lethargic; worst body aches; temperature peaked at 100.8° F; enlarged lymph node on her left armpit; severe headaches; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (severe headaches), MYALGIA (worst body aches), BODY TEMPERATURE INCREASED (temperature peaked at 100.8° F), LETHARGY (lethargic) and INFLUENZA LIKE ILLNESS (felt like she had the flu) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product PARACETAMOL (TYLENOL) for Headache, Myalgia, Fever, Flu and Lymph nodes enlarged.    The patient's past medical history included Blood pressure, Thyroid disorder, Acid reflux (esophageal) and Cholesterol. Concomitant products included ACETYLSALICYLIC ACID (ASPRIN) for an unknown indication.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On an unknown date, the patient started PARACETAMOL (TYLENOL) (unknown route) at an unspecified dose. On 04-Mar-2021, the patient experienced HEADACHE (severe headaches). On 05-Mar-2021, the patient experienced MYALGIA (worst body aches), BODY TEMPERATURE INCREASED (temperature peaked at 100.8° F) and LYMPHADENOPATHY (enlarged lymph node on her left armpit). On 06-Mar-2021, the patient experienced LETHARGY (lethargic). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (felt like she had the flu). On 04-Mar-2021, HEADACHE (severe headaches) had resolved. On 05-Mar-2021, MYALGIA (worst body aches) and BODY TEMPERATURE INCREASED (temperature peaked at 100.8° F) had resolved. On 06-Mar-2021, LETHARGY (lethargic), INFLUENZA LIKE ILLNESS (felt like she had the flu) and LYMPHADENOPATHY (enlarged lymph node on her left armpit) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient mentioned ,she had a very mild symptoms of covid-19  in mid of October. Patient states she is taking concomitant medication for blood pressure, thyroid, acid reflux and cholesterol.
I had advised the staff, like I was previously advised, of the mild reaction last time.  They had the shot administered by a Dr there and the personnel were alerted to keep an eye on me. Shot was administered and they kept me at the seat with the doctor for several minutes before placing me in the waiting room. Metallic type taste and smell occurred in less than 5 minutes of the shot.  Slight swelling of the tongue and throat. Caused the need to repeatedly clear my throat and more coughing than the first time. Could not catch my breath easily and felt labored. Was light heads, eyes watering and a little ?foggy.? Used my inhaler but that did not seem to help.  Used my emergency inhaler a 2nd time about 2 minutes later.  Was advised my face and chest were very red and a party sat with me for a bit.  Took about 10 minutes before the breathing/coughing finally seemed to be resolving.  The party checking on me stayed in the room and rolled a chair with wheels near incase she need to take me to the ER just down the hallway.  She also had an epee pen and advised me she had it with her just in case.  My tongue and roof (Ridges) of the mouth was noticeably swollen to me after just an hour.  After about an hour and half there, the allergic reactions seemed to stabilize and the staff and I both felt we were out of the woods but I was not ok to leave yet.  Coughing subsided drastically and color became normal again.  Kept there for a little bit longer? I was at the hospital until 5:20pm-ish.  Was advised to go home and take another antihistamine, drink a lot of water and rest.  They also advised to report adverse reactions stating I had another mild allergic reaction to the 2nd shot. Came home and took another zyrtec and went to bed because I was so tired.  Woke up to my arm being extremely sore but the area of the shot was not raised this time but was warm and painful to the touch.  Felt very achy, headache, and exhausted the next day like I had the flu.  Slept the majority of the next day.  Smell and taste resolved within a few hours but the roof of the mouth is still rigid but metallic taste and soreness is gone.  I can tell the tongue is no longer swollen.  It?s no longer bulging to the side of my teeth and I no longer seem to have a little lisp. This is now April 30, 2021 at 8:15am.
Headache, NauseaVomiting, body aches, fatigue Narrative:  employee reports: no symptoms the day of injection, the following afternoon developed headache and on 1/8/2021 also developed nausea, body aches, and fatigue. (no fever) OTC tylenol and allergy medication seem to help.
Severe Headaches x3 days 1/7-1/9. Redness and induration at injection site on 1/10. 9cmX9cm redness and warmth.  No redness initially .
After injection administrated I had nerve zingers or nerve sensations in my left shoulder, neck, and left arm.  I have had left side shoulder tingling and random numbness on left side shoulder ever since. I had left side facial numbness staring 7/2022 and had left side arm and leg numbness and weakness from a transient stroke  in 10/2022. No other health conditions.
She got her vaccine, and the next morning on 3/3/21 she woke up with her throat feeling like she had a sore throat, except she was not sick.  Her voice was shaking and the more she talks the worse she gets and is painful to talk.  She also has excessive coughing, which has continued since then.  The coughing is out of control, which makes her throat worse.  Regular OTC cough medicine does not help.  she went to her doctor who did not know what it was.  She went to a neurologist who has seen her for essential tremors in her hands, but she told her that she had it in her throat.  She also went to a throat specialist and said that it was also essential tremors, which she felt that he did not know, and then her neurologist confirmed that is what it was.  It's a permanent condition.   The neurologist said that it was related to the vaccine.  She thought that it would go away and she informed her that the vaccine set off the tremors in her throat.  She takes the Propranolol for her essential tremors and that dose was increased due to it now in her throat.  Her neurology disorder provider is Dr. "private".   The more she talks the worse it gets, it hurts her to talk, and the voice gets shakier.    She got her 2nd vaccine and there was no difference, and got worse.  She would start coughing that would not stop.  She was informed that the tremors will spread to her legs and the rest of her body.  She has uncontrollable movements to her arms, and the medicine does help her not to go "too spastic".
Hives; This is a spontaneous report from a contactable consumer (patient). A 17-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in right arm on 24Sep2021 at 12:30 (at the age of 17-years-old) as dose 2, single for COVID-19 immunisation. The patient previously received the first dose of bnt162b2 on 02Sep2021 at 12:00. The patient had no relevant medical history. There were no concomitant medications.  The patient experienced hives on 26Sep2021 at 12:00. The event was treated with Benedryl. The outcome of event was not recovered.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Extremely heavy periods and severe pain for more than 8 days before and after period.  Also have been experiencing irregular menstrual cycles for the last 5 months after first dose of vaccine, this has been excruciating and debilitating for at least a week every month. I have never experienced so much pain and heavy bleeding in my life. My period has been like clockwork for the last 22 years, as I have always tracked my monthly cycle. Since I got the vaccine my period has changed dates, comes 10+ days early and is so heavy that  it feels like a hemorrhage with large clots of blood and is the most painful it has ever been. I have been unable to work or walk due to the extreme pain.
Approx. 25min after injection pt began c/o her entire left arm and down to her hand burning.  Describes it as inside her am and not just the skin.   Vitals WNL No other complaints initially.  After observation for approx. 10 min pt's fingers on her left hand appeared discolored.  Burning in her arm unchanged.  Transported to urgent care by RN.  During transport pt began c/o burning sensation in her left calf.
became emotional; more outspoken; experiencing brain fog; hard time concentrating; This spontaneous case was reported by a consumer and describes the occurrence of EMOTIONAL DISTRESS (became emotional), LOGORRHOEA (more outspoken), FEELING ABNORMAL (experiencing brain fog) and DISTURBANCE IN ATTENTION (hard time concentrating) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Aug-2021, the patient experienced EMOTIONAL DISTRESS (became emotional), LOGORRHOEA (more outspoken), FEELING ABNORMAL (experiencing brain fog) and DISTURBANCE IN ATTENTION (hard time concentrating). At the time of the report, EMOTIONAL DISTRESS (became emotional), LOGORRHOEA (more outspoken), FEELING ABNORMAL (experiencing brain fog) and DISTURBANCE IN ATTENTION (hard time concentrating) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication were reported. No treatment medication were reported.   This case was linked to MOD-2021-321126 (Patient Link).
The vaccine administrator was very rough and gave me a huge bruise at the injection site. I also bled quite a bit. I have never had a bruise in 10 years of getting the flu shot.
Adult patient was given a pediatric dose; Adult patient was given a pediatric dose; This case was reported by a pharmacist via call center representative and described the occurrence of underdose in a adult patient who received HBV (Engerix B pediatric) for prophylaxis.   On 8th April 2022, the patient received Engerix B pediatric. On 8th April 2022, unknown after receiving Engerix B pediatric, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown.   Additional Information: GSK Receipt Date: 08-APR-2022 Reporter's Comments: Pharmacist reporting adult patient over the age of 20 years old was given a pediatric dose of Engerix-B, which led to underdose and adult use of a child product. Health care professional (HCP) did not had any further adverse event details at this time.  HCP gave permission for safety to follow up. The reporter consented to follow up.
Red swollen spot below injection site. Diameter started out about 1/2"  and by the next day was almost 2" in diameter and was hot to the touch. It feels hard to the touch, like a knot under the skin.
Chronic fatigue syndrome/ ANS dysregulation developing within 6 weeks of vaccination. Including anxiety, depression, fatigue, sleep disruption, digestive issues, and chronic pain.
weak; sick all over; terrible headache; fever 101F; aches/pain in the back of neck and shoulder; aches/pain in the back of neck and shoulder; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (aches/pain in the back of neck and shoulder), ASTHENIA (weak), ILLNESS (sick all over), HEADACHE (terrible headache) and PYREXIA (fever 101F) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included CITALOPRAM for Anxiety, ROSUVASTATIN for Cholesterol, PANTOPRAZOLE for Hernia, ATENOLOL, AMLODIPINE and POTASSIUM CHLORIDE for Hypertension, COLECALCIFEROL (VITAMIN D 3) for Supplementation therapy.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, the patient experienced NECK PAIN (aches/pain in the back of neck and shoulder), HEADACHE (terrible headache), PYREXIA (fever 101F) and ARTHRALGIA (aches/pain in the back of neck and shoulder). On 23-Apr-2021, the patient experienced ASTHENIA (weak) and ILLNESS (sick all over). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of UNK, qid and ACETYLSALICYLIC ACID (ASPIRINE) for Adverse event, at a dose of UNK, qid. On 17-Apr-2021, NECK PAIN (aches/pain in the back of neck and shoulder), HEADACHE (terrible headache), PYREXIA (fever 101F) and ARTHRALGIA (aches/pain in the back of neck and shoulder) had resolved. On 23-Apr-2021, ASTHENIA (weak) and ILLNESS (sick all over) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Apr-2021, Body temperature: 101 (High) fever 101F. On 22-Apr-2021, SARS-CoV-2 test: positive (Positive) COVID-19 positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-274024 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 23-Apr-2021: Second dose information was provided; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Client disclosed she developed dizziness 3 hours after receiving the first dose of COVID vaccine Janssen. The client stated the dizziness lasted 6-7 hours. The client also reported feeling tired after receiving the first dose of Janssen COVID vaccine.
Pt. states noticed face started itching early evening then noticed started to have hives - on face and neck. Called pharmacy and spoke to pharmacist - took BENADRYL.
Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Mild, Systemic: Nausea-Mild, Additional Details: Within a minute or so of receiving her vaccine, patients became sweaty, dizzy, and had to put head between her knees. After that initial reaction, patient had initial signs and symptoms of nausea (described nausea, cheek bloated intermittently as if to vomit). Side effects resolved within a 15 minute period. Patient sat for a total of 30 minutes, and left pharmacy with no apparent lingering effects.
Itching all over the body; Blisters all over her body; Swollen Injection Site (3.5" Inches); This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching all over the body), BLISTER (Blisters all over her body) and INJECTION SITE SWELLING (Swollen Injection Site (3.5" Inches)) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced PRURITUS (Itching all over the body), BLISTER (Blisters all over her body) and INJECTION SITE SWELLING (Swollen Injection Site (3.5" Inches)). At the time of the report, PRURITUS (Itching all over the body), BLISTER (Blisters all over her body) and INJECTION SITE SWELLING (Swollen Injection Site (3.5" Inches)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: No specific follow-up information recorded.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 01-OCT-2013, the patient were vaccinated with a dose of ZOSTAVAX (lot# J001694, expiration date 08-MAY-2014, dose, frequency, route and indication not reported). The vaccine was stored improperly at temperatures up to 21F from 01-JUL-2013 to 08-OCT-2013. On 08-OCT-2013, the vaccine was discarded. No adverse effects were reported. It was unspecified if the patient had sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Redness day of injection which gradually got worse. Rash broke out in arm as well. Dexterity of fingers decreased continues to today. Have to grab coffee up with 2 hands because afraid that he will drop it. On 11/11 went to Urgent Care and doctor specified there was an issue with rotator cuff and sent pt to orthopedist. Orthopedist took X-ray but nothing found. Given cortisone shot which did not help at all. Has no strength in arm. Told to wait and see if improves.
CPhT, administered 0.25ml of Pfizer instead of 0.3ml for a booster shot. Patient was notified of error and did not want to come back in for the additional 0.05ml dose that was shorted.
Dose 1: About 5 minutes after injection slight dizziness and ear felt stopped up. Later that night chest was flushed. Flushing lasted about 2 hours Dose 2: Due to flushing with last infusion, nurse told me to wait there 30 minutes after infusion. About five minutes after starting getting a headache and left ear was stopped up. Was told to take Benedryl if rash(flushing) came back with this infusion and to report symptoms to CDC. Headache and nausea felt till next day. Felt sick and headache riding in car. At 0130 am on 2/18/21 was awoken by pain under right arm. Very mild swelling noted but very sore to put arm down and tender to touch. Underarm still sore as of today Feb 20, 2021. Second day joint pain in shoulders, elbows, fingers, and knees. Joint pain improved but still there as of Feb 20, 2021. Ibuprofen and Tylenol did not help headache or joint pain. Third day headache off and on with nausea once, right hip pain.  Feb 20, 2021 Fourth day underarm and joint pain improving , nasal and ear congestion
Went into Dysautonomia flare, high heart ratecand blood pressure ended up in er at 3am
This Non valid spontaneous report was received from a registered nurse and refers to an unspecified number of unspecified patients of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On dates on or after 21-SEP-2017, the patients were vaccinated with improperly stored dose of PEDVAXHIB for prophylaxis, lot# N000238 with expiration date of 25-OCT-2019, lot# N003701 with expiration date of 01-NOV-2019, lot# N008079 with expiration date of 02-DEC-2019, lot# N012920 with expiration date of 07-FEB-2020 (strength, dose, route and frequency were not reported); or with improperly stored dose of RECOMBIVAX HB for prophylaxis, lot# N020613 with expiration date of 05-MAY-2020, lot# N002202 with expiration date of 04-NOV-2019, lot# N011851 with expiration date of 19-DEC-2019; or with improperly stored dose of ROTATEQ orally, for prophylaxis, lot# N000175 with expiration date of 20-SEP-2018, lot# N005618 with expiration date of 04-OCT-2018, lot# N005078 with expiration date of 22-NOV-2018; or with improperly stored dose of VAQTA for prophylaxis, reported lot# M019924 with expiration date of 02-SEP-2018, lot# N008823 with expiration date of 26-MAY-2018. No adverse effects were reported. It was stated that the vaccines underwent a temperature excursion of 32°F (degrees Fahrenheit) to 35°F for 40 minutes; No previous temperature excursion was done. The call was because of a "data logger". This is a non-valid case due to lack of patient identifier. Follow up information was received from the registered nurse 30-APR-2018. The nurse stated the temperature excursion was stable and they had two refrigerators that held the related vaccines. The nurse was not able to provide patients' names or initials, or ages, but was able to provide number of patients, gender information, and vaccination dates. This report referred to a female patient vaccinated with improperly stored ROTATEQ (oral; lot# N005078 with expiration date 22-NOV-2018) on 28-SEP-2017. Upon receipt of follow-up information it was determined that this case is now valid because patient identifier was received. This is one of several reports received form the same reporter(link reports: 1710USA004069, 1805USA001661, 1805USA004617, 1805USA004618, 1805USA004590, 1805USA004591, 1805USA004592, 1805USA004593, 1805USA004674, 1805USA004675, 1805USA004676, 1805USA004677, 1805USA004678, 1805USA004679, 1805USA004680, 1805USA004682, 1805USA004683, 1805USA004967, 1805USA004968, 1805USA004969, 1805USA004970, 1805USA004971, 1805USA004972, 1805USA004973, 1805USA004974, 1805USA004975, 1805USA004976, 1805USA004977, 1805USA004978, 1805USA004979, 1805USA004980, 1805USA004981, 1805USA004982).
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of PROQUAD subcutaneously, lot # N020615, expiration date 22-JAN-2019, albumin status rHA; and lot # N010246, expiration date 25-SEP-2018; (dose was not reported) for prophylaxis; administered along with a properly stored sterile diluent, subcutaneously, lot # L028663, expiration date 29-MAR-2018 (dose was not reported) for prophylaxis. It was reported that the vaccine was exposed to temperature of -9 degrees Celsius to 8 degrees Celsius, for a time frame of 4 hours and 4 minutes. The temperature excursion was recorded by a data logger and no previous excursions were reported for the vaccines. No adverse effects were reported. There was no product quality complaint (PQC) involved. This is one of several reports received form the same reporter (MARRS # 1712USA008050, 1712USA008779, 1712USA008780, 1712USA008781, 1712USA008782, 1712USA008783, 1712USA008784, 1712USA008786, 1712USA008787.). Sender's Comments: US-009507513-1712USA008050.
10/10/2022, approximately 12:15 pm, I started to get a runny nose. My nose was sore and irritated.  It cleared up.  When I went to bed, I started to feel pressure around my eyes. It gradually got worse.  Day 2, I had laryngitis. The runny nose lasts about an hour every morning.  Yesterday the pain in my sinuses was worse. This morning, it is not as bad, but I am upright.  The pressure is not as bad when I am up.
Chills, shakes, muscle soreness, injection sight pain, headache, tiredness,
Vaccine admin at 12:00 pm.  At 12:20 pm, patient developed redness-rash to chest, neck area.  12:25 pm oral Benadryl admin. 12:45 Patient feeling ok.  Left vaccination facility with instructions to seek medical services if symptoms re -appear, worsen.
On day 5 the injection site soreness seemed to radiate down the top of the arm to the wrist. At first just hurt to touch, then muscle soreness. Currently, 3 weeks out, it is muscle weakness.