chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Writer notified of patient with throat swelling and completed assessment:  "throat feels big" pounding headache, dizziness. Given 50 mg Benadryl and laid on back with feet elevated.  Patient does not wish to have  facility epinephrine auto-injector or emergency assistance at this time. She also does not wish to use her epi-pen. VSS- 125/78, 20, 71, 100% RA. No wheezing, stridor or labored breathing. No c/o chest tightness or flushing. Patient remained A&Ox3 throughout experience. At 1243, patient reported throat "feels a little bigger" and still did not wish to call 911 or have epinephrine. Given 50 mg Benadryl liquid PO as she could still swallow. At 1249, patient reported swelling improving slightly. VS 66, 14, 130/90, 99% RA. At 1302,  swelling continues to improve. VS 65, 18, 131/81, 100% RA. Patient has epi-pen and was shown how to use it if needed. Husband driving home. Patient reports headache and dizziness have also improved. Reports that she had reaction with her first dose that she was able to manage with Benadryl and her PCP recommended her to still get second dose with prophylactic medications.   f/u 1700 phone call: Patient reports her swelling has reduced greatly and she was able to eat dinner. She is having the same rash- (red/warm, no hives) that she experienced the first time which had lasted 3-4 days. Advised to seek further assistance should swelling increase, or any respiratory symptoms begin. She is feeling much better.
2/28/07 At 4 month physical - mother stated that infant was fussy for 2 weeks after 2 months immunizations.
Fever within 24 hours, body aches, chills, lethargy   Menstrual spotting 13 and 14 days post vaccination. Longer than average menstrual cycle by about 7 days.
Headache, Fever, fatigue Narrative:  feeling better 2/3/2021 but still having some fatigue. reported to have taken Ibuprofen (no dosage provided) and is back to  work 2/3/2021
Hallucinations/ Have seen ghosts; A spontaneous report was received from a consumer who is a male patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced hallucinations and seeing ghosts.  The patient's medical history, as reported, included problem in eye that caused patient to see weird things some years ago. Concomitant medications were not reported.  On an unspecified date, the patient received their first two planned doses of mRNA-1273 (Batch number: unknown) for the prophylaxis of COVID-19 infection.  On an unspecified date, the patient experienced hallucinations and seeing ghosts.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of event, hallucinations and seeing ghosts, was unknown.; Reporter's Comments: This case concerns a 72-year-old male patient who received their first of two planned doses of mRNA-1273 (Lot unknown), and who experienced the serious unlisted event of hallucinations.  Based on the current available information and temporal association between the use of the product and the onset of the event after vaccination, a causal relationship cannot be excluded.
On 20MAR2023 my Doctor diagnosed the following information; CBC shows elevated lymphocytes consistent with CLL.  There are may treatments for CLL but I have no indication for treatment.
Severe Right Shoulder Pain at injection site, unable to use right arm and difficulty sleeping due to pain.
I began a very heavy ?period? that lasted 2 weeks 8/8-8/23, it began 2 days after the 1st shot. Then after the 2nd shot I began to bleed very heavy again. The bleeding lasted  5 days 9/12-9/17. I have not had a period since then.
Lump in injection site, infection of site. Treated with sulfamet/TMP.
In August of 2018 (around a month after getting the shot), i started having diarrhea and mild stomach pain. . The stomach pain got worse. Instead of it occuring just when i ate food, it was constant stomach pain. I lost 65 pounds, have diarrhea 3-4 times a day. It continued to go on and i eventually got an ultrasound on September 28th, 2018. From there I was referred to a GI specialist had a series of labs and colonoscopy/endoscopies and was diagnosed with an autoimmune disease (Crohn's). It took almost a year and a half to receive a diagnosis.
I received the vaccine on 4/2/21.  I started feeling tightness, soreness and throbbing pain in my right calf on 4/28/21.  On 5/4/21 the pain was unbearable and there was swelling in my calf/ankle.  On 5/5/21 I got an ultrasound that confirmed I have a DVT blood clot in my right calf and I got blood work done that confirmed everything was normal with my health (liver function, platelet counts...).  I was prescribed Xarelto 15mg and began taking Xarelto on 5/8/21.
Chest pain; High Blood pressure; Dizziness; Difficulty breathing; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CHEST PAIN (Chest pain), HYPERTENSION (High Blood pressure), DIZZINESS (Dizziness) and DYSPNOEA (Difficulty breathing) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 30-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 01-Apr-2021, the patient experienced CHEST PAIN (Chest pain) (seriousness criterion hospitalization), HYPERTENSION (High Blood pressure) (seriousness criterion hospitalization), DIZZINESS (Dizziness) (seriousness criterion hospitalization) and DYSPNOEA (Difficulty breathing) (seriousness criterion hospitalization). The patient was hospitalized for 2 days due to CHEST PAIN, DIZZINESS, DYSPNOEA and HYPERTENSION. At the time of the report, CHEST PAIN (Chest pain), HYPERTENSION (High Blood pressure), DIZZINESS (Dizziness) and DYSPNOEA (Difficulty breathing) outcome was unknown. Not Provided          No adverse event as Medical History was reported.  Concomitant medication information was not provided.  She was brought into Emergency Room on 01Apr2021 and was hospitalized for two days for because of the symptoms of chest pain, High Blood pressure, Dizziness and difficulty breathing. She thought she was having a heart attack.  Treatment information was not provided/ unknown.  Action taken with mRNA-1273 in response to the event was not provided/ unknown.  Company comment: Very limited information regarding this events has been provided at this time.  The company physician considers the reported onset date is typo. Further information has been requested.; Sender's Comments: Very limited information regarding this events has been provided at this time.  The company physician considers the reported onset date is typo. Further information has been requested.
anaphylaxis; A Spontaneous report was received from a nurse concerning unknown patient who received Modern's COVID-19 vaccine (mRNA-1273) and experienced Anaphylactic reaction.  The patient's medical history was unknown.  Concomitant medications are not reported.  On unknown date prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) for prophylaxis of COVID-19 infection.  On an unknown date the patient experienced Anaphylactic reactions. The event is considered as medically significant.   No treatment was given. No lab details are provided.  No Action taken with mRNA-1273 in response to the events was not reported.   At the time of this report, the outcome of the events were unknown.; Reporter's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
eyelids are swollen; red underneath her eyes; they are real puffy; This is a spontaneous report from a contactable consumer (patient).   A female patient of an unspecified age received BNT162B2 (PFIZER-BIOTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration on 12Feb2021 as dose 1, single for COVID-19 immunisation.  The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced eyelids are swollen, red underneath her eyes, and they are real puffy. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
A 65-year-old patient reports that at the time of receiving the Pfizer vaccine batch FK9895 on 03/31/2022 she began to have pain in her left arm. After that on Sunday 3/04/2022 the same began to feel a pain in the arm which radiates to the other arm. It indicates that since then she cannot lift her arm up to 90 degrees where the pain begins. On the other hand, it indicates that sugar began to rise as well as cholesterol.
Weak/After 1st dose she was down for 10 days/She totally failed for 10 days; Dizzy; Joints hurt all over; Couldn't stand; She further stated that she did not take the 2nd dose due to her side effects.; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weak/After 1st dose she was down for 10 days/She totally failed for 10 days), DIZZINESS (Dizzy), ARTHRALGIA (Joints hurt all over), DYSSTASIA (Couldn't stand) and PRODUCT DOSE OMISSION ISSUE (She further stated that she did not take the 2nd dose due to her side effects.) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ASTHENIA (Weak/After 1st dose she was down for 10 days/She totally failed for 10 days), DIZZINESS (Dizzy), ARTHRALGIA (Joints hurt all over), DYSSTASIA (Couldn't stand) and PRODUCT DOSE OMISSION ISSUE (She further stated that she did not take the 2nd dose due to her side effects.). At the time of the report, ASTHENIA (Weak/After 1st dose she was down for 10 days/She totally failed for 10 days), DIZZINESS (Dizzy), ARTHRALGIA (Joints hurt all over), DYSSTASIA (Couldn't stand) and PRODUCT DOSE OMISSION ISSUE (She further stated that she did not take the 2nd dose due to her side effects.) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No concomitant information was provided by the reporter.  No treatment information was provided.
nose bleeds 2 wks after IZ administration; occurred in Jan of 2019 also See attached IZ record re: Vaccines given 1/25/19 and 10/16/19
He was doing good after the second shot a bit of a headache and tired.  The day before we had got a home test he had a stuffy nose, congestion, throwing up, mild cold symptoms, sore throat. headache. We finally found a home test and it immediately registered positive for COVID-19, it was a very strong marker. For a week he felt the symptoms of fatigue, fever, congestion, stuffy nose, sore throat, and very lethargic.  A week after he tested negative he would occasionally wake up feeling nauseous and there were time he would have to come home from school from vomiting. He now has motion sickness and has been prescribed Zofran for long trips. His headaches are still lingering and he will wake up with ones  he fears may be strong enough to set off his nausea.
I experience symptoms similar to heart attack. I had chest pain and loss of feeling. I had to go to emergency room and release after 6 hours. My doctor believe it's an stomach issues.
At 10:10 AM, patient reports "not feeling well." Patient states he is dizzy and light headed. Diaphoresis noted. Vitals stable. Patient denies shortness or breath. NO rash; no itching, burning, or pain. Patient placed in seated position and monitered. At 10:35, patient states he "feels much better." Patient denies dizziness and light headedness. At 10:55, patient ambulated with steady gait noted. Patient discharged at 11:00.
Client woke with cough, sore throat, HA, nausea, no vomiting and femoral fever of 100 degree F, dizziness. Ibuprofen and TYLENOL given. 10/20/09 a.m. No fever; "Hacking" cough, sore throat and mild HA persist.
Patient reported that she received J$J vaccine in the primary series in 04/2021 with no adverse side effects. She received pfizer booster on 02/01/2022 at our facility. Patient reports left arm pain started within two weeks of 02/02/2022. Pain started in left upper  chest that radiated down the left arm on two different occasions. Patient reports inability to reach behind her back and carry any weight on the left arm ever since. Patient reports going to the ER where they detected high platelets and troponin levels. Hospital then released her after 12 hours after monitoring her bloodwork every hour and having consistent levels.
One day after receiving the first dose of the SARS-CoV-2 vaccine the patient developed headache, neck pain, and fever.  Her symptoms persisted for 2 more days and she then presented to the hospital where she was diagnosed with meningitis with a CSF WBC of 8.  Her infectious work up of the meningitis has not revealed the cause to date.
temperature went up to 103.8degF; headache; feeling fatigue, tiredness; nauseous; This spontaneous case was reported by a nurse and describes the occurrence of PYREXIA (temperature went up to 103.8degF), HEADACHE (headache), FATIGUE (feeling fatigue, tiredness) and NAUSEA (nauseous) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A21A and 028L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced PYREXIA (temperature went up to 103.8degF), HEADACHE (headache), FATIGUE (feeling fatigue, tiredness) and NAUSEA (nauseous). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. In March 2021, PYREXIA (temperature went up to 103.8degF), HEADACHE (headache), FATIGUE (feeling fatigue, tiredness) and NAUSEA (nauseous) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Pyrexia: 103.8degf (High) 103.8degF.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication not provided.   This case was linked to MOD-2021-017478, MOD-2021-017391 (E2B Linked Report).; Sender's Comments:  MOD-2021-017478: MOD-2021-017391:
Patient is having severe leg pain & cramps mainly in the thigh area.  she states it has affected her everyday life even painful at sleep
Pregnant 36 weeks, 4 days. EDD 11/15/23 10/20/23: Contractions 10/21/23: Increased resting heart rate 10/22/23: Loss of mucus plug
Loss of mobility in arm followed by aches in chest, back, arms, hands, and head. Also, sharp pains in back of head area and cold sweats. Arm still has minimal mobility and headache persists but other symptoms have subsided.
8/1/23 loss of appetite, drowsy,sleepiness. 8/2/23 16:00 felt warm, sleeplessness, no appetite, sweating, severe diarrhea (12 + liquid BM diapers), discomfort, screaming in tears, unable to  be consoled late into the next morning. 100.3 temp. 8/3/23 redness in face, neck, continued severe diarrhea, screaming while holding on hand supported by other hand (as if in aching pain). 103 temp. Produced 13+ liquide BM diapers while in the kneeling fetal position with arms tucked in. Cried out for help throughout the night. 8/4/23 weight loss (1.5 pounds), contiuned discomfort, unable to sleep. difficulty with balance and corrdenation. Similar events with 2nd series with same vaccine (lot#U7536AA).
After the shot i had slight swelling in my neck glands, not too bothersome.  Severe insomia up from 10 pm to 5  am , really bad headache, pain  pressure in my ears, {   Couldl feel my heart beating in my ears } Took acetamiphen and cold compress to the head and eyes, seemed to help.  Awake at 10 with no further symtoms so far.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 47-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17Dec2020 as dose 1, single (Lot number: EK5730) and on 15Oct2021 as dose 3 (booster), single (Lot number: FE3592) at the age of 46 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Type 1 diabetes" (unspecified if ongoing); "Addisons disease" (unspecified if ongoing); "celiac" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing). Concomitant medication(s) included: HYDROCORTISONE; NOVOLOG; LEVOTHYROXINE; FLUDROCORTISONE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 19Oct2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (19Oct2022) positive; (03Nov2022) positive, notes: I tested again for Covid 19 and was positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Paxlovid Treatment start date: 21Oct2022, stop date: 26Oct2022. No known allergies. Sender's Comments: Drug ineffective depends on many factors including pharmacokinetics, severity of disease and patient general health condition. However, on conservative basis, the possible causality cannot be excluded.
received moderna vaccine after J&J vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (received moderna vaccine after J&J vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (received moderna vaccine after J&J vaccine). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (received moderna vaccine after J&J vaccine) had resolved.            No concomitant medication information was provided. No treatment medication information was provided. As they heard on the news the J&J was not as effective and so then they got two full doses of Moderna COVID-19 vaccine as well.
booster dose last Thursday; sore arm; This is a spontaneous report received from a contactable reporter (Consumer or other non-HCP) from medical information team. The reporter is the patient.  An elderly female patient received bnt162b2 (BNT162B2), administration date 16Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 2), administration date: Apr2021, for COVID-19 Immunization, reaction(s): "chills", "headache", "nausea", "fever"; Bnt162b2 (Dose 1), for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 16Dec2021, outcome "unknown", described as "booster dose last Thursday"; PAIN IN EXTREMITY (non-serious) with onset Dec2021, outcome "unknown", described as "sore arm".  Additional information: The patient has received both doses of the Pfizer COVID-19 vaccine as well as the booster dose last Thursday and she has not felt any of the symptoms like she did after receiving the first two doses. She stated after the Second dose in Apr she "really got hit with it" She stated she had chills, fever, nausea, headache and she was wondering why she has not had much of a reaction this time other than a sore arm. The patient was asking about the booster increasing the antibody levels by 50-fold. She stated she was told to multiply 50 by whatever her level was. She has spoken to people who have had the booster and their antibodies went up to 30%. She has also spoken with her dentist and his level was 800 and after he received the booster, he waited a month and got his antibodies test, and it went o 20,000 or 30,0000. The patient was advised to speak to her Healthcare professional.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Received first dose of vaccine on 2/9/2021, then hospitalized with covid infection on 2/16/2021
patient came in for a booster dose and was given a second booster though she did not meet current guidance for a 2nd booster
after 9 hours swollen tongue.; tingling lip; tip of tongue tingling; left side of face swollen; This is a spontaneous report from a contactable consumer, the patient. A 57-years-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8727) via unspecified route of administration in the left arm on 27Mar2021 at 15:30 (at the age of 57-years-old), as a single dose for COVID-19 immunisation. The patients medical history included high blood pressure, obese. The patient had no known allergies. Concomitant medication included, lisinopril (MANUFACTURER UNKNOWN), unspecified multi vitamins (MANUFACTURER UNKNOWN), ergocalciferol (VITAMIN D), ascorbic acid; rosa canina (VITAMIN C) for an unknown indication. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to vaccination the patient was not tested positive for COVID-19. Since the vaccination the patient had not been tested for COVID-19. About 9 hours after shot on 28Mar2021 at 12:30, the patient woke up with swollen tongue and took Dimetapp. Awoke 7 hours later on 28Mar2021 at 07:30 and noted left side of face was swollen and lips and tip of tongue were tingly and took Dimetapp again. Adverse events did not result in Doctor or other healthcare professional office/clinic visit. Therapeutic measures taken for swollen tongue, swollen face, tingly lip and tip of tongue included Dimetapp. The clinical outcome of swollen tongue, swollen face and tingly lips, tongue tip was unknown.    No follow-up attempts are needed. No further information is expected.
I had sudden onset moderate left facial pain then mild weakness and numbness on the left side of my face. It?s slightly better now but has not resolved. It started about 3 hours after my vaccine. No other symptoms.
Primary Adverse Event:  Tinnitus in right ear, slight loss of hearing in right ear.  First noticed 3/14 at approximately 3:00pm (28 hours after vaccination)  and has continued through time of this report.   Additional side effects: Fever and chills started approximately 10 hours after vaccination and persisted for approximately 7 hours.  Fatigue began approximately 4 hours after vaccination and has gradually become less as of the timing of this report.
Entire right deltoid, hot, slightly reddened, slight tenderness, full range of motion.
Within 12 minutes of receiving vaccine patient with c/o lightheadedness and nausea. Pt states he hadn't eaten prior to appt. Crackers and Pepsi provided. Excessive perspiration noted. Emesis x1 noted. Patient became unresponsive to questions and had 15 second period of unconsciousness. EMS called and arrives on scene. Patient alert/oriented x3 after brief loss of consciousness.  1:20pm- pt reports complete relief of sx and leaves ambulatory with driver. Pt refuses further medical attention at ER although highly encouraged. Risks explained by EMS personnel and understanding voiced.