chrisvoncsefalvay/vaers-outcomes huggingface dataset:
had bad itchy flare up; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (had bad itchy flare up) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product DUPILUMAB (DUPIXENT) for Atopic dermatitis.    No Medical History information was reported.   On 24-Dec-2020, the patient started DUPILUMAB (DUPIXENT) (Subcutaneous) 150 milligram per milliliter every two weeks. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RASH PRURITIC (had bad itchy flare up). At the time of the report, RASH PRURITIC (had bad itchy flare up) outcome was unknown.            No relevant concomitant medications reported. No treatment information provided.   Most recent FOLLOW-UP information incorporated above includes: On 02-Jul-2021: Additional  information regarding address was updated. On 07-Jul-2021: Additional information contains no new information.
Tingling and numbness in both arms and hands, but mainly in the left arm.  The tingling and numbness began about a day after the shot and I thought at first that it had to do with yardwork, but it has continued for about nine days so far.  It goes away for a few hours a day and some nights are not as bad as others, but it's painful - like your hand/arm falling asleep for an extended period of time - and interferes with sleep as well as concentration during the day.
I go for blood workup every six months for over 8 years ref my testoserone shots weekly. RX by my Drs and monitored closely ref looking for elevated PSA. Never ever have I had an issue.. and after 3 Pfizer Covid Shots my AST ALT Liver function numbers are off the charts!  AST 84 ALT 74  I am NOT a drinker, healthy and have a personnel trainer and eat a clean diet!
At around 8 pm on 3/5/2021 started with a severe headache, around 10 fatigue and muscle aches. Unable to get to sleep, around 12am 3/6/2021 fell asleep but kept wake up very hot, No fever but did have sweats. Around 2 am 3/6/2021 headache so severe had to get up and take Aleve. Had throbbing behind eyes and sensitive to light. This lasted till around 9pm 3/6/2021. Had fatigue most of the day also. All symptoms gone on 3/7/2021 except I have had a couple of small headaches on and off till 3/9/2021.
This spontaneous report as received from a licensed practical nurse and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of ZOSTAVAX (lot # M032141, expiration date 27-OCT-2017 and lot # M035692, expiration date 07-NOV-2017) (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion between 15 and 46 degrees Fahrenheit for 2 hours and 20 minutes. Data logger was involved. There were no previous excursions reported. This is one of 2 reports received from the same reporter. Sender's Comments: US-009507513-1707USA005371.
Since june 10th I had experience a headache non stop every day, it feels like my head is really heavy and my neck is contracted, I had gone to the doctor, recommend a HEAD TAC but everything is ok, also I have been taken tylenol everyday for the headache. It is unbeareble this pain.
Pt had allergic reaction in place of vaccination, redness, swelling. Gave ice and explained all posible side effects. Pt said that he is alergic to propylen glycol. Pt left clinic without any side effects.
fever, chills, aches, headache - felt like COVID symptoms.  I feel like it set back my recovery from a bad case of COVID.  I went back to having the fatigue and weakness.  Had COVID right after Thanksgiving (Saturday) through December.
I started to have a runny nose and a sore throat, so I tested on June 21st and it was positive. I had no temperature for the entire time, and I had already had a cough. My doctor gave me an inhaler Wixela and Paxlovid. I began the treatment on June 22nd. I felt better after taking the Paxlovid. I went to my primary care physician and had a CT scan due to the cough, chest tightness, and shortness of breath. The results were abnormal. I was placed on Levaquin. I am still in the process of recovery. This is my 2nd bout with COVID-19. I have an MRI scheduled for August 15 and at that time I think that I will be referred to a pulmonologist.
headache, sensitive to light, eyes hurt, fatigue, body aches( felt like i was punched in various place on my body, mild dizziness(foggy feeling), left arm swelling and pain at injection site, stomach pain(mild nausea and achy empty feeling)
On 04-01-2021 I felt very queasy but this symptom resolved by the end of the day. On 04-06-2021, at night I developed a bad headache, had flu-like symptoms. On the next day when I woke up, I still had a bad headache which lasted from 04-06-2021 to 04-18-2021. I contacted my PCP who performed lab work, platelets panel, did a Covid test and did a CT scan of the brain which all my tests came out normal.
Information has been received from a registered nurse referring to an unspecified number of patients of unknown age and gender. Concurrent historical condition was not provided. On unknown dates the patients were vaccinated with improperly stored PNEUMOVAX 23 (lot # L040178 with expiration date 18-AUG-2017, L04081 with expiration date 18-AUG-2017, M000592 with expiration date 12-OCT-2017, dose and route unknown). Concomitant therapy was not reported. There was no previous temperature excursion. The vaccine was stored under 0 Celsius degree for 72 hours. Data logger was not involved. No symptoms reported. This is one of several reports received from the same reporter. Additional information has been requested.
Woke up with hives & sores in mouth. Sought Medical Doctor 1/18/2010, 1/22/2010, 1/25, 2010 and Neurologist 1/25/2010, 2/1/2010, MRI's 1/28/2010, 1/29/2010, Dizzy Center 2/3/2010. Continuing Therapy and ENT and Neurologist.
feel a little beat up; No motor skills, couldn't get out of bed , couldn't reach for my phone; felt freezing; feverish; shaking uncontrollably; like I was seizing; heart burn; acid reflux; felt hot; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (shaking uncontrollably), DISCOMFORT (like I was seizing), DYSPEPSIA (heart burn), GASTROOESOPHAGEAL REFLUX DISEASE (acid reflux) and FEELING HOT (felt hot) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.    On 01-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Nov-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Nov-2021, the patient experienced TREMOR (shaking uncontrollably), DISCOMFORT (like I was seizing), DYSPEPSIA (heart burn), GASTROOESOPHAGEAL REFLUX DISEASE (acid reflux), FEELING HOT (felt hot), FINE MOTOR SKILL DYSFUNCTION (No motor skills, couldn't get out of bed , couldn't reach for my phone), FEELING COLD (felt freezing) and PYREXIA (feverish). On an unknown date, the patient experienced MALAISE (feel a little beat up). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency. On 02-Nov-2021, TREMOR (shaking uncontrollably), DISCOMFORT (like I was seizing), DYSPEPSIA (heart burn), GASTROOESOPHAGEAL REFLUX DISEASE (acid reflux), FEELING HOT (felt hot) and PYREXIA (feverish) had resolved. At the time of the report, MALAISE (feel a little beat up) had not resolved and FINE MOTOR SKILL DYSFUNCTION (No motor skills, couldn't get out of bed , couldn't reach for my phone) and FEELING COLD (felt freezing) had resolved.            No concomitant medications were reported.   This case was linked to MOD-2021-373361 (Patient Link).
Increased resting heartrate for about 6 months before returning to baseline. Normal resting heart rate for myself is high 40's/low 50's. Post vaccination, my resting heart rate was mid to high 70's for about 6 months.
Patient received Moderna dose as their first dose on 9/20/21 -- not having side effects at this time
Tingling in both arms and legs worsening with time, overall body weakness and muscle weakness, pain in joints and feelings of joint swelling, sharp stabbing pains throughout body, feelings of hot and cold sensations throughout body, sinus pain and pressure, fatigue   All symptoms worsening after 1 week post vaccine
(Orange) Covid Pfizer 5-11 years old was administered to this 3 y/o child.
Patient received Pfizer COVID vaccine on 2/10/21 and 3/12/21. Patient presented to the ED on 9/3/21 with positive COVID symptoms (nasal congestion, mild cough and loss of taste/smell) for consideration of monoclonal antibody on. In the ED, she was afebrile with normal oxygenation. Patient was not hypoxic and not candidate for targeted treatment such as Remdesivir/Dexamethasone. Patient also did not meet criteria of reduced ability to form immunity in vaccinated individuals to receive REGEN-COV treatment.  She was, however, found to be in new onset Afib and was admitted for treatment of Afib with RVR (diltiazem drip). Patient was discharged the next day on 9/4/21.
tested Negative for Hepatitis B in April 2021 & July 2021; had a temperature of 99.4F.; This spontaneous case was reported by a nurse and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (tested Negative for Hepatitis B in April 2021 & July 2021) and PYREXIA (had a temperature of 99.4F.) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 026L20A) for COVID-19 vaccination.     The patient's past medical history included Hepatitis B (Patient get tested every 6 months.) in 1980.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PYREXIA (had a temperature of 99.4F.). In April 2021, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (tested Negative for Hepatitis B in April 2021 & July 2021). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (tested Negative for Hepatitis B in April 2021 & July 2021) and PYREXIA (had a temperature of 99.4F.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2020, Hepatitis B: positive (Positive) Positive. On 03-Feb-2021, Body temperature: 99.4 (High) 99.4. In April 2021, Hepatitis B: negative (Negative) Negative. In July 2021, Hepatitis B: negative (Negative) Negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided.  Treatment information was not provided.   This case was linked to MOD-2021-425676 (Patient Link).
Hospitalized 10/12/2021; COVID-19 positive 10/10/2021; fully vaccinated  10/12/2021 admission note: CHIEF COMPLAINT: Pneumonia due to COVID-19 virus   Assessment/Plan    ASSESSMENT/PLAN: Acute respiratory failure with hypoxia Pneumonia due to COVID-19 - symptom onset 10/8; positive test on 10/10 - fully vaccinated with Pfizer March 2021 - CXR- patchy ground glass attenuation bilaterally - procal 0.44 - continue decadron - unable to give remdesivir due to AKI; if renal function improves, could consider starting - will give ceftriaxone and doxycycline (QTc 483) - required non-rebreather with EMS; now weaned to 5 L NC - continue to wean supplemental oxygen as able   Acute encephalopathy - suspect related to COVID - wife reports mild confusion over the past several days - check VBG - monitor; consider further neurologic workup pending progress 10/16/2021 note: ASSESSMENT / PLAN:   Acute hypoxemic respiratory failure  COVID-19 Pneumonia Concern for superimposed bacterial pneumonia Currently on HF 100% with NRB - consult MICU Symptom onset 10/8; positive test on 10/10 Fully vaccinated with Pfizer March 2021 Dexamethasone 6 mg daily x 10 days Unable to give remdesivir due renal function Continue ceftriaxone and doxycycline (QTc 483) Supportive care Acute encephalopathy Suspect related to COVID Note from 10/17/2021: - Pulmonary:  # Acute hypoxemic resp failure 2/2 COVID 19 pneumonia  # s/p intubated (10/16/21) - Patient was max ed out on O2 settings via NRM and HiFlo NC. He was short of breath and tachypnic. After discussing it with family and pt decision was made to intubate this morning - ABG post intubation pO2 91; pCO2 43; pH 7.5;  HCO3 34, %O2 Sat 93. - symptom onset 10/8; positive test on 10/10 - fully vaccinated with Pfizer March 2021 - CXR- patchy ground glass attenuation bilaterally - procal 0.44 (elevated); on ceftriaxone and azithro x 5 days (completed course) - dexamethasone 6 mg daily x 10 days - Proned at 4 am today - Not paralysed  10/20/2021 note:  - dexamethasone 6 mg daily x 10 days - Proned at 4 am starting on 10/17. Significant improvement in P/f ratio from 90 to 200 on proning. Now on 40% FiO2 and PEEP 12, sating at 97%. Stopped proning 10/19 - Not paralysed
Needle went into the fluid sack and made it painful; needle went into the fluid sack and made it painful; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of WRONG TECHNIQUE IN DEVICE USAGE PROCESS (Needle went into the fluid sack and made it painful) and PAIN (needle went into the fluid sack and made it painful) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, the patient experienced WRONG TECHNIQUE IN DEVICE USAGE PROCESS (Needle went into the fluid sack and made it painful) and PAIN (needle went into the fluid sack and made it painful). On 20-Apr-2021, WRONG TECHNIQUE IN DEVICE USAGE PROCESS (Needle went into the fluid sack and made it painful) had resolved. At the time of the report, PAIN (needle went into the fluid sack and made it painful) outcome was unknown.            Concomitant medication was not reported. Treatment medication reported included steroids. The action taken with  mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable, reporter didn't provide causality assessment.
Bad headache; Really sore arm; Body aches; Chills; Slightly elevated temperature 99.6; Tiredness; This is a spontaneous report from a non-contactable consumer, the patient. A 60-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735) via an unspecified route of administration in the left arm on 20Apr2021 at 10:00(at the age of 60-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history.  The patient had allergies to medications, food, or other products. The patient did not receive any medication within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the left arm on 30Mar2021 at 09:45 (at the age of 60-years-old) as a single dose for COVID-19 immunisation.  Prior to  the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 20Apr2021 at 17:00, the patient experienced really sore arm, body aches, chills, slightly elevated temperature 99.6 degrees, tiredness. On 21Apr2021, the next day, the patient experienced bad headache. The clinical outcome of the events really sore arm, body aches, chills, slightly elevated temperature 99.6 degrees, tiredness and bad headache the next day were resolved on an unknown date in Apr2021.  No follow-up attempts are possible. No further information is expected.
After 20 minutes patient felt blurriness and could not move her body for a few seconds , after sitting and drinking some water, patient felt much better and was able to walk
extreme fuzziness  crying insensibly like in pain would not move the leg where she got her shots and if she would she would cry even more... bathed her and no medication since most medications are on recall
Heart flutters; headache; itching; tired; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC FLUTTER (heart flutters), HEADACHE (headache), PRURITUS (itching) and FATIGUE (tired) in a 59-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059E21A) for COVID-19 vaccination. No Medical History information was reported. On 22-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CARDIAC FLUTTER (heart flutters), HEADACHE (headache), PRURITUS (itching) and FATIGUE (tired). At the time of the report, CARDIAC FLUTTER (heart flutters), HEADACHE (headache), PRURITUS (itching) and FATIGUE (tired) outcome was unknown.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.No concomitant medications were provided.No treatment medications were provided.Company comment: This is a spontaneous case concerning a 59-year-old patient of unknown gender with no reported medical history, who experienced the unexpected, non-serious, AESI event of cardiac flutter, unexpected, non-serious event of pruritus and expected, non-serious events of headache and fatigue. The events cardiac flutter, pruritus, headache and fatigue exact occurrence unknown but stated that the events occurred after the first dose of mRNA-1273 vaccine administration. No reported treatment information. The outcome of the events cardiac flutter, pruritus, headache and fatigue were unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.This case was linked to MOD-2022-456871 (Patient Link). Sender's Comments: This is a spontaneous case concerning a 59-year-old patient of unknown gender with no reported medical history, who experienced the unexpected, non-serious, AESI event of cardiac flutter, unexpected, non-serious event of pruritus and expected, non-serious events of headache and fatigue. The events cardiac flutter, pruritus, headache and fatigue exact occurrence unknown but stated that the events occurred after the first dose of mRNA-1273 vaccine administration. No reported treatment information. The outcome of the events cardiac flutter, pruritus, headache and fatigue were unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
c/o palpatations 1-2 wks p/dose & reocccurred 1 wk ago-lasting intermittantly over a 9hr-period;
Moderna COVID-19 Vaccine EUA  Moderate to Severe headache for 48 hours post vaccine. Needed one dose of tylenol. Began 5 minutes post injection
Patient experienced red sensitive touch in the early morning.  Redness area is about 2 inches. Patient has some hard spots around the area and some itching
nausea, headache, fever, chills, muscle ache occurred after 8 hours post injection
She started to feel her throat close up; She had a rash; This spontaneous case was reported by an other health care professional and describes the occurrence of THROAT TIGHTNESS (She started to feel her throat close up) and RASH (She had a rash) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jan-2021, the patient experienced THROAT TIGHTNESS (She started to feel her throat close up) and RASH (She had a rash). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. In January 2021, THROAT TIGHTNESS (She started to feel her throat close up) and RASH (She had a rash) 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.   She takes no regular medications.  After receiving that dose of the vaccine, patient was waited at the vaccination facility for 30 minutes without issue then was driving home, and 15 minutes after leaving the pharmacy, patient were started to feeling throat close up and had a rash. Patient was called the pharmacist who instructed to take Benadryl. Her symptoms completely resolved within an hour.  The pharmacist also called patient on 3-FEB-2021 to inform that patient should not receive the second dose of the vaccine.
adult patient received dose from pediatric vial; This spontaneous case was reported by a pharmacist and describes the occurrence of INCORRECT DOSE ADMINISTERED (adult patient received dose from pediatric vial) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1416B) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milligram. On an unknown date, the patient experienced INCORRECT DOSE ADMINISTERED (adult patient received dose from pediatric vial). At the time of the report, INCORRECT DOSE ADMINISTERED (adult patient received dose from pediatric vial) outcome was unknown.       For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter. No treatment information was provided by the reporter.
Patient reported bruising to legs the day after receiving vaccine (waited to report until 9/14/2021) - advised to speak with iron infusion prescriber.
Injection site area felt slightly firm and itchy, upon looking at arm saw the tale-tell red ?rash? that others had previously reported, diameter of rash 2.5-3?. Next morning, rash no longer visable, but slight itchiness/burning sensation remains, not noticeable unless I actually think about it, does not affect ability to function.