chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Headache Runny nose, sore throat, lymph node swelling under l arm,lear and eye pain, L lower jaw pain  Narrative:  To see her private physician is symptoms do not improve
Intense muscle pain, left butt.; This is a spontaneous report from a contactable consumer, the patient. An elderly patient of unknown gender received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202) via an unspecified route of administration in the left arm on 17Mar2021, as a single dose for COVID-19 immunisation. Medical history included high Blood Pressure (BP) and cholesterol which were under control. The patient had no allergies to medications, food, or other products. Concomitant medications included atorvastatin (MANUFACTURER UNKNOWN), levothyroxine (MANUFACTURER UNKNOWN), lisinopril (MANUFACTURER UNKNOWN) and omeprazole (MANUFACTURER UNKNOWN). The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3246) via an unspecified route of administration in the left arm on an unknown date in 2021, 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 20Mar2021, the patient experienced intense muscle pain in left butt for 3 days. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event intense muscle pain in the left butt was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected
I had muscle pain in my arms and legs so it's difficult to get up, sit down and pick things up. It also prevents me from sleeping well because its constant pain.
bad sunburn; Feeling hot and cold; Like someone dropped bugs on you; Bleeding; like someone dropped bugs on you and you can't scratch hard enough; Atopic dermatitis/ Eczema; This spontaneous case was reported by a consumer and describes the occurrence of SUNBURN (bad sunburn), FEELING OF BODY TEMPERATURE CHANGE (Feeling hot and cold), DERMATITIS ATOPIC (Atopic dermatitis/ Eczema), FEELING ABNORMAL (Like someone dropped bugs on you) and SKIN HAEMORRHAGE (Bleeding) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    In December 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2022, the patient experienced DERMATITIS ATOPIC (Atopic dermatitis/ Eczema). On an unknown date, the patient experienced SUNBURN (bad sunburn), FEELING OF BODY TEMPERATURE CHANGE (Feeling hot and cold), FEELING ABNORMAL (Like someone dropped bugs on you), SKIN HAEMORRHAGE (Bleeding) and SCRATCH (like someone dropped bugs on you and you can't scratch hard enough). At the time of the report, SUNBURN (bad sunburn), FEELING OF BODY TEMPERATURE CHANGE (Feeling hot and cold), DERMATITIS ATOPIC (Atopic dermatitis/ Eczema), FEELING ABNORMAL (Like someone dropped bugs on you), SKIN HAEMORRHAGE (Bleeding) and SCRATCH (like someone dropped bugs on you and you can't scratch hard enough) outcome was unknown.            No Concomitant medication information provided.  Patient received Moderna COVID-19 Booster vaccination on December when it came out.  Patient was diagnosed with atopic dermatitis and the symptoms included pruritus/itches a lot and is worse in bed and rash erythematous/one solid red rash, like patient was scalded or had a bad sunburn.  No treatment medication information provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-610560, US-MODERNATX, INC.-MOD-2022-610542 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-610560:Relative's case US-MODERNATX, INC.-MOD-2022-610542:Master case (Reporter's case)
Information has been received from a physician concerning a 21 year old male with no allergies and a history of positive lyme titer, who on 8/4/1995 was vaccinated with a dose of varicella virus vaccine live. There was no concomitant medication. On 6/16/2005 the patients varicella antigen test was 9.6, less than 15 is not immune by the lab. AT the time of the report the patient had not recovered. No product quality complaint was involved. Additional information has been received.
Sore left arm,  Sore muscles and Joints, Chills   All affects lasted 16 hours
injection site hot; injection site hard; tenderness at the injection site; injection site red; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE WARMTH (injection site hot), VACCINATION SITE INDURATION (injection site hard), VACCINATION SITE PAIN (tenderness at the injection site) and VACCINATION SITE ERYTHEMA (injection site red) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure and Cholesterol. Concomitant products included CITALOPRAM.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On 02-Jan-2021, the patient experienced VACCINATION SITE WARMTH (injection site hot), VACCINATION SITE INDURATION (injection site hard), VACCINATION SITE PAIN (tenderness at the injection site) and VACCINATION SITE ERYTHEMA (injection site red). At the time of the report, VACCINATION SITE WARMTH (injection site hot), VACCINATION SITE INDURATION (injection site hard), VACCINATION SITE PAIN (tenderness at the injection site) and VACCINATION SITE ERYTHEMA (injection site red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Patient medicine includes blood pressure, cholesterol and bone density. Also citalopram for her anxiety. Treatment information was not provided.
Pain rt shoulder, moderate feels pain increasing. Cannot sleep at night. Myalgia after flu shot vaccine. Pain level 8/10. Pain level decreased to 4 at discharge.
AT INJECTION SITE RED ROUND SPOT 1 INCH THE SEPERATE  RED RAISED PATCH  4X6 INCH  UNDER INJECTION SITE ITCHUNG AND HOT
I have a nexplanon arm implant for birth control which has stopped my period for the last 3-4 years. I started spotting and sort of having a period about three weeks after getting the second moderna covid shot. This is really strange for me and abnormal, and want it to be a side effect that is included in patients knowledge.
Narrative: Patient was not previously COVID-19 positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. PMH significant for coronary arteriosclerosis, cardiac pacemaker, prostate cancer, hyperlipidemia, htn, ckd stage 3. No cause of death or recent hospitalization, illness docuemented. Deceased 4/21/21 per wife.
Four days after the vaccine, I started experiencing hives all over my body (mostly concentrated around my chest, stomach and face). My eyes swelled shut multiple times. I went to my primary doctor. I was prescribed prednisone and it was recommended I get the 2nd vaccine with the help of the steroids to help my side effects. I got the 2nd vaccine, and experienced a fever of 103 for 3 days with flu-like symptoms. The morning after my 2nd vaccine, I experienced a swollen tongue. I  contacted my primary doctor, and decided to take Benadryl to see if it went down before going to the hospital. My tongue swelling went down after a 4-5 hours. I have been experiencing severe hives daily since March 20, 2021.
Information has been received from a health professional concerning an 8 year old female with no known drug allergies who in approx. 8/01 was vaccinated with a dose of MMRII. Concomitant therapy included fluticasone propionate (Flovent). A day after vaccination, the pt presented to the physician's office with an injection site reaction that was red and swollen. It was noted that the pt was afebrile. No other symptoms were reported. No further information was available. Additional information has been requested.
Pt had the vaccine, went through observation period of 15 minutes and had been discharged.  Left the building and was in car driving away when numbness began in her face.  She describes feeling like she had been to the dentist and had a novacaine injection, her right ear felt as if it were plugged with cotton.  Her left arm and tongue felt a little numb as well.  Vital signs were BP 140/96, AP-96, Respirations 20 unlabored.  Color pink.  Alert and oriented x3.  Signs and symptoms did not increase, but did persist and so local EMS notified.  No medications given at this time.  Care resumed by EMS/transported to hospital. Patient had no history of this type of reaction.
I am unwell; This is a spontaneous report from a Sponsored Program . A contactable consumer (patient) reported for herself that a female patient of an unspecified age received bnt162b2 (BNT162B2), via an unspecified route of administration on 23Jan2021 at SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported.  The patient experienced I was unwell (non-serious) on an unspecified date with outcome of unknown. Adverse event details: Her 1st Covid-19 Pfizer Vaccine shot on 23Jan, she was suppose to return on 13Feb but I am unwell, when she went to one of a hospital last Saturday they said she had to get the 2nd dose in the previous location.  Information on the lot/batch number has been requested.
There was no adverse event, the syringe came from manuf already pulled back to 0.5m. so when filling multiple syringes for a vaccine clinic this one was mistakenly not filled with vaccine and the first dose given to her was only 0.5 ml of air. She was no injured, did not complain of pain and was observed for 15 to 20 minutes after. She was also given the correct dose of Janssen 0.5ml.
Lower half of right upper arm down through elbow area red, swollen, warm to touch, and very tender that started 11-19-19 - the day after injection; patient took Tylenol for discomfort; symptoms were subsiding by time reported to clinic on 11-21-19.
At 9:50 am employee received a call from pt. stating she had pulled car over d/x "anaphylactic reaction to flu shot", stated she administered Epi pen to herself at that time and has been taking BENADRYL q-3 hours. Employee called her back at 10:34 telling her to go to her doctor or ER immediately to be checked. Patient stated  she "didn't have time to go to the doctor she was too busy." Said she had "Epipen for a variety of allergies." RN called pt at 11:09 am 10/14/16 stated still having anaphylactic reaction. RN instructed her to call 911 now, to seek medical attn. now".
Started with redness and itching at injection site. Redness and swelling moved down her arm into the medial arm near her elbow. She developed a fever of 100.7 degrees F. She went to an urgent care, who prescribed her cephalexin.
Patient felt hot and I got him water and an ice pack. He then turned white and started to become lethargic.  He laid down on the floor to cool off and put his knees up. I got him two more ice packs and the color returned to his face. After about 20 minutes he got back up into the chair and felt better.
Numbness in left leg severe enough that could not walk properly.  Heart was racing per patient,  Pulse felt normal approx. 80bpm.  Left foot was tingly.  Wheelchaired to Emergency Room.
Arm pan,  redness around the area, headache muscles pain on my knees and hips (inner and outer)  took 2 penicillin pills (Amoxicillin 500 mg )each . and within and hr my pain was completely gone. Got up sunday and felt fine
lower lip and left hand side has been twitching; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE TWITCHING (lower lip and left hand side has been twitching) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B21A and 0433B21A) for COVID-19 vaccination.     The patient's past medical history included Hay fever, Dust allergy and Hypothyroidism in 2015. Concurrent medical conditions included Fruit allergy.   On 26-Mar-2021 at 12:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021 at 12:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Mar-2021 at 11:30 AM, the patient experienced MUSCLE TWITCHING (lower lip and left hand side has been twitching). On 04-Jul-2021, MUSCLE TWITCHING (lower lip and left hand side has been twitching) had resolved.            No concomitant medication were reported No treatment medication were reported. The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in the event is not applicable   Most recent FOLLOW-UP information incorporated above includes: On 17-May-2021: Follow-up  received on 17-MAY-2021 in which second dose of vaccination, patient medical history, Event information is updated.
contracted Covid on 11/21/22 - symptoms included scratchy throat, chest cough, nasal congestion, fatigue - contacted Doctor immediately and was put on Paxlovid - Covid negative on day 10 - cough continued for a couple weeks
pt indicated that became ill the day p/recvd the Hep B inject; sx were chills for 5 days, lethargy, aching, nausea, a cough & a cold;
PPV23 was ordered but PREVNAR 13 was administered to patient. No adverse outcomes.
pt recv vax 18DEC95 & 2 wk post vax exp sore throat, h/a, n/v, initial temp 103, rt jaw pain, enlarged cervical lymph nodes, rt flank pain, dizziness & breathing pain;fever dec to 99;pt neurologist;
This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with (Merck) VARIVAX (lot # J012816, expiry date 10-OCT-2015 and lot number K005180 with expiry date 10-APR-2016, dose 0.5 ml, subcutaneous). Concomitant medications were not reported. The reporter stated that (Merck) VARIVAX was administered to patients post temperature excursions. The reporter also stated that (Merck) VARIVAX was affected by prior excursions (no MARRS number available yet) and there also seemed to be additional excursions to (Merck) VARIVAX that have not been reported yet. There was no stability data provided. No adverse effects were reported. Outcome of administration of (Merck) VARIVAX post temperature excursions was unknown. Additional information has been requested.
Fever up to 102 deg x 2 days post-vaccine. Entire anterior (L) thigh red, swollen on 8/21/08. 8/25/08- raised, red pink spots on both feet and ankles. One week later raised, blotchy rash on (L) thigh.
VACCINE EXPOSURE DURING PREGNANCY; This spontaneous pregnancy report received from a consumer via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient received the J and J Covid-19 Vaccine and 1 month later discovered that she was pregnant. The patient was gravida 1, para 1. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced vaccine exposure during pregnancy. The date of the patient's last menstrual period and expected delivery date were not reported. On an unspecified date, the pregnancy resulted in a live birth. The patient gave birth to a baby of unspecified sex. Birth outcome was unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaccine exposure during pregnancy was not reported. This report was non-serious. This parent/child case is linked to 20220617386.
The morning after the second vaccine, pressure in both ears, right ear felt clogged and clicking. The next day, left ear starting ringing and hasn't stopped since.  It was been 1 day short of 3 weeks post second vaccine.  Both ears continue to feel pressure, however, it is the ringing that is the most annoying that prompted me to report this. Plan on following up with an ENT MD.
This spontaneous report as received from a pharmacist refers to a female patient of unknown age with none medical history and none drug allergies. On 03-NOV-2014 the patient was vaccinated with PNEUMOVAX23 (lot # K007826, exp 03-FEB-2016, subcutaneous). There was no concomitant drug. The reporter reported that since the date of administration, the patient had reported that the site around the injection was red, warm and swollen. Pharmacist stated that the patient sought help and had TYLENOL as treatment for pain. No lab was performed. The outcome of adverse events was reported as not recovered/not resolved. Additional information has been requested.
Patient reported feeling a little dizzy and nauseated after being vaccinated with girlfriend  Patient soon after had syncopal episode Patient appeared clammy and pale and diaphoretic Patient seen by medical team Blood pressure 91/45 and heart rate 61 Patient provided water and repeat BP was 109/61 Patient refused medical transport and signed ama form but will have girlfriend drive him to hospital
Information has been received from a 28 year old female patient with epilepsy, asthma and an allergy to carbamazepine (TEGRETOL) who on 18-SEP-2006 was vaccinated with a dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). Concomitant therapy included escitalopram oxalate (LEXAPRO), lorazepam, "lomectol," zolpidem tartrate (AMBIEN), and fluticasone propionate (FLOVENT). The patient stated that since her vaccination she has been experiencing dizzy, tired, has headaches and felt nauseous. No medical attention was sought. As of the report date the patient has not recovered. Additional information has been requested. 01/05/2007 Follow up information has been received from a physician concerning the patient with a seizure disorder who on 18-SEP-2006 at 9:50 a.m. received her second dose of GARDASIL, lot # 653937/0637F, in the left deltoid. The physician reported that the patient complained of right lower quadrant pain and mild nausea after receiving the vaccine. A pelvic sonogram was performed to rule out ovarian cyst. The patient had not yet recovered. Additional information is not expected.
Patient received vaccine (HPV) on 4/19/17. On 5/9/17 presented to urgent care for Left arm pain. She returned to our clinic on 5/10/17, for pain developing 2 days prior. There was 1.5cm round firm area.
I started getting a sore throat the night before. I woke up the next morning with a cough and a sore throat. At that time, I took a COVID-19 home test which was positive on March 22, 2023. I had a fever around 101 the next day. The fever broke overnight Friday into Saturday. I still had a cough. By Monday I had a really bad cough, so I stayed home from work. The cough was really bad, and I was constantly clearing my throat. I did a telehealth appointment with my doctor, and she thought I had a sinus infection from COVID-19. She prescribed AUGMENTIN to clear up the sinus infection. I stayed home from work for 2 weeks. I did a 2nd COVID-19 test on March 27, and was still positive.
Tooth abscess appeared approximately 2 days after getting vaccination shot for COVID-19.  The tooth affected had a root canal completed late June 2020.  I have had low-level pain since the root canal.  It's possible I had a mild infection around the tooth after the operation and, after receiving my COVID-19 shot on Monday,  the infection flared up because my immune system was activated by the vaccination shot.
I have a breakthrough COVID; I have a breakthrough COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 33 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 01Mar2021 (Lot number: EL3247) at the age of 32 years as dose 2, single and intramuscular, administered in arm left, administration date 08Feb2021 (Lot number: EL3247) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 23Nov2021, outcome "recovering" and all described as "I have a breakthrough COVID". The event "i have a breakthrough covid" and "i have a breakthrough covid" was evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (30Nov2021) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19. Clinical course: The patient did not had covid prior vaccination and any known allergies. The patient did not receive other vaccine in four weeks.
Gave Hepatitis A imminization, patient was fine, seated, remained seated after shot. I talked to him then returned to pharmacy then he fell off chair for less than 30 seconds. Syncope. He came to and waited for about 20 minutes gave him some cool cloths talked to hime and he was fine. I ask him to wait 15 minutes after the injection and he did.
pt had hives on trunk area on the morning of 28JUN94; pt didn't have nay hives around inject, fever; appeared healthy x/hives; immun div recommended that pt see pvt MD;
generalized itching; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for Injection; Lot Number: EN6200) via an unspecified route of administration in arm left on Wednesday, 17Feb2021 10:00 (at the age of 69-year-old), as dose 1, single for COVID-19 immunization. Medical history included kidney transplant from 2011 to 2011, takes a lot of medicines (routine immunosuppressant medications), diagnosed allergies, compromised immune status, respiratory illness, genetic /chromosomal abnormalities, endocrine abnormalities including diabetes and obesity. The patient's relevant family medical history was none. No other vaccinations within four weeks prior to the first administration date of the suspect vaccines. No vaccines administered on same date with the Pfizer vaccine considered as suspect. The patient's concomitant medication included unspecified routine immunosuppressant medications. On 17Feb2021, Wednesday after receiving the vaccination, the patient experienced generalized itching (starting in the afternoon), with no rash but got itching everywhere. she had no problems breathing and no swelling. She confirmed that she had a history of a kidney transplant and was taking routine immunosuppressant medications. Patient asked if generalized itching was a common side effect from the vaccine and asked if she should get her second dose. At transplant centre, nephrologist said it was okay to get the shot. At about 10: 00 AM, in the afternoon her skin has been itching everywhere. She has no problems breathing, no swelling. No lab and relevant test. The clinical outcome of the event was not resolved. The reporter assessed case non-serious.  No follow-up attempts are possible. No further information is expected.
pt recv vax & became weaker during the day,upon admission was markedly quadraparetic;could move head & speaks w/diff;CBC WNL;adm w/GBS;intubated on ventilator;tracheostomy performed 24NOV96;
pain left arm continues,  light head, headache, nausea,  heaviness in chest, tired,  temperature 99.8