chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Cold feeling in the chest; This spontaneous case was reported by a non-health professional and describes the occurrence of FEELING COLD (Cold feeling in the chest) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jan-2021, the patient experienced FEELING COLD (Cold feeling in the chest). At the time of the report, FEELING COLD (Cold feeling in the chest) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient is taking other unspecified medication. No treatment was reported by the reporter.   This case was linked to MOD-2021-406734 (Patient Link).
px had a syncope 15-20 mins after vaccination was given.  px was check by doctor BP 106/71. HR 74 BPM pulse ox 99 % RA.  physical exam unremarkable.. Px was lying down for 15 mins, drink pedialyte and recover well. went to home with mother.
Shingles/rash/nerve pain on left side Had a telemedicine diagnosis was prescribed antibacterial ointment to prevent further spread of the herpes zoster virus. Symptoms lasting one month
5 pm began itching at nape of neck. By 8 pm I noticed itching  in crook of both elbows. By 9 pm I had rash on arms, legs, neck, trunk front and back. Took 2 benadryl capsules. Rash was mostly gone next day and I didn't take more benadryl until bedtime, 1 capsule. Rash persisted in patches on my upper abdomen, under breasts, for about 3 days.
Patient called next day said developed fever, chills and body aches. Patient also vomited earlier during the day.
20 min after vaccine skin itching and irritation, no resp involvement , improved with PO Benadryl and IV solumedrol
Turned pale, then gray with extreme crying. Stopped enroute back to clinic at fire station. Tachycardic, otherwise stable, then to ER. No fever.
one of 4 pt to devel fever of 101-102 deg F, uncontrollable irritability, and a local rxn post vax
redness; big red round spot; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (big red round spot) and ERYTHEMA (redness) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008B21A and 047B21A) for COVID-19 vaccination.     No history was provided by the reporter.  Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID], DULOXETINE, PROGESTERONE, METOPROLOL, OMEPRAZOLE, ASCORBIC ACID (VITAMIN C ACID), ZINC, LACTOBACILLUS REUTERI (PROBIOTICA) and METHYLCELLULOSE (CITRUCEL) for an unknown indication.   On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced RASH MACULAR (big red round spot). On 06-May-2021, the patient experienced ERYTHEMA (redness). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, RASH MACULAR (big red round spot) and ERYTHEMA (redness) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No laboratory details was given. Action taken with mRNA-1273 in response to the event was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: Follow up information received on 12 May 2021 contains non-significant information.
Symptoms began at 12:30AM Symptoms began as itchy, inflamed hands and feet Next swelling of lips began When seated on the toilet, began to sweat uncontrollably as itchy and inflammation increase  Called for partner to check in on me at this time.  Tried to get into the bathtub to help with itching but was unable to due to sudden urge to use restroom.  Had one bowel movement after returning to toilet Proceeded to continue to sweat and ears began to ring.  Vision became blurred, seeing purple spots.  Speech was slurred and limbs were heavy and weak.  Could think clearly but unable to do simple tasks such as grasp a cup of water without effort.  Vision completely blackout at this point. I did not faint and still able to communicate but could not see anything other than blackness.  This happened twice between 10 minute span. Once I was able to lie down, Vision and hearing cleared.  Chills began then and itching continued. I was wrapped in three blankets unable to stop chills and shakes.  Eventually I was able to relax and stop the chills and fall back to sleep at 3AM.  It is now 2:05PM and I am  experiencing some itching, fatigue, and cramping
This spontaneous case reported by a consumer, describes the occurrence of vaccination site pain (arm is sore at the site of injection) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 007B2A) for COVID-19 immunization. No medical history reported. On Mar 31, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19  vaccine), unknown route; 1 dosage form. On Mar 31, 2021, patient experienced vaccination site pain (arm is sore at the site of injection). At the time of the report, vaccination site pain (arm is sore at the site of injection) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. Concomitant medication provided: birth control pills. No treatment information provided.
Administered only the powder, used non-GSK diluent; Administered only the powder, used non-GSK diluent; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate dose of vaccine administered in a 12-year-old patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced inappropriate dose of vaccine administered and wrong solution used in drug reconstitution. On an unknown date, the outcome of the inappropriate dose of vaccine administered and wrong solution used in drug reconstitution were unknown.   Additional Information: GSK Receipt Date: 17-OCT-2022. Reporter's Comments: The reporter stated that a nurse administered only the powder component of Menveo after using a non-GSK diluent.  The reporter did not give consent to follow-up. Additional Supportive Information: The patient received only the powder component of Menveo after using a non-GSK diluent which leads to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.
Father came in 8/5/02 at 16:15 c/o swelling to R deltoid are where imm. were given 8/2/02. Seen at clinic this week end. Advised to give Tylenol cold compress. States swelling is better today. Advised to do as above instructed. Return if increase swelling, no redness noted.
This spontaneous report was received from a healthcare worker refers to multiple unspecified patients of unknown gender and age. Information regarding patients' medical history, concurrent conditions, drug reactions/allergies and concomitant therapy were not provided. On unknown dates, the patients were vaccinated with improperly stored doses of ZOSTAVAX (lot # L032403, expiry date: 26-NOV-2016). Healthcare worker stated that the vaccine underwent a temperature excursion at 9 degree Fahrenheit for 666.5 hours. There were no previous temperature excursions. Healthcare worker confirmed that the vaccine was administered on unspecified dates before their expiration dates. No adverse effects were reported. This is one of the six reports received from the same reporter. Additional information has been requested.
This spontaneous report as received from a medical assistant refers to multiple unspecified patients of unknown gender and age. Information regarding patients' medical history, current conditions, drug reactions/allergies and concomitant medications information were not provided. On unknown dates, the patients were vaccinated with improperly stored PEDVAXHIB (lot # L042257, expiry date: 17-AUG-2018) (incorrect product storage). Medical assistant reported that the vaccine reached 32 F for 28 hours and 30 minutes. A data logger was used and the vaccines were back in range. There were no prior excursions. No adverse experiences were reported. This is one of the two reports received from the same reporter. Additional information has been requested.
shortly after shot, serious feelings of depression took over, despair, severe loneliness and feelings of isolation, agitation.
ACUTE DVT OF RIGHT LEG, UNSPECIFIED VEIN 11/18/2022 ASPIRATION PNEUMONIA ACUTE DVT OF LEFT FEMORAL VEIN 11/18/2022 ASPIRATION PNEUMONIA
FREEZING, SHIVERING, SHAKING, DIZZINESS, THEN BURNING UP. STATES AROUND 8PM BEGINNING TO FEEL BETTER.
4SEP97 lt deltoid area peeling cover of skin & healing lesions-scabbed over;mom states that on 29AUg97 pt lt arm became swollen, hard & had several blisters
This spontaneous report as received from a license vocational nurse refers to a patient of unknown age and gender. Patient's medical history, concurrent conditions and concomitant therapy were not reported. On 18-AUG-2015, the patient was vaccinated with a dose of improperly stored VARIVAX (Merck) (lot number reported as K008821, Expiry date: 19-JUN-2016) (dose and route were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Slight Cough; hot and cold; headache; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Slight Cough), FEELING OF BODY TEMPERATURE CHANGE (hot and cold) and HEADACHE (headache) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2021, the patient experienced COUGH (Slight Cough), FEELING OF BODY TEMPERATURE CHANGE (hot and cold) and HEADACHE (headache). At the time of the report, COUGH (Slight Cough), FEELING OF BODY TEMPERATURE CHANGE (hot and cold) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Little bit pain in her entire body and today is Wednesday and the pain is very is a lot never seen that before; body ache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACICNE), administration date 20Mar2021 (Lot number: EN6203) as dose 1, single for COVID-19 immunisation. Relevant medical history included: "Dementia" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PAIN (non-serious) with onset 22Mar2021, outcome "not recovered", described as "Little bit pain in her entire body and today is Wednesday and the pain is very is a lot never seen that before; body ache".  Additional information: The patient was 83 (unit not reported). The patient had the shot given to her this past Saturday, which was 20Mar2021, Saturday, on 21Mar2021 she was completely fine, 22Mar2021 she was feeling a little bit pain in her entire body and today was Wednesday and the pain was very was a lot never seen that before. The patient did not have fever, she did not have any other symptoms it was just a body ache and it was her first shot not the second. She was 83 she had dementia (captured as history) so we talk to the doctor and doctor said to get the shot.  No follow-up attempts are possible. No further information is expected.
Approximately 16 hours after the inoculation, I developed a fever of 100.1 that lasted throughout the next day.  Administered 2 doses of Tylenol during the next 12 hours and my temperature gradually came down to normal.  During all this time I was extremely fatigued and slept on and off for most of the day.  In addition, there was a 6" diameter redness surrounding the injection site.  My arm was extremely sore and it hurt to move for the first 24 hours and remains tender at this reporting.
Began to develop extreme exhaustion throughout day following shot.  At approximately 5:00pm, began to develop a headache, severe joint pain throughout body.  Approximately 2 hours later, began to develop a fever that rose to 102.5.  Immediately took Tylenol.  Fever last for approximately 24 hours as did joint pain.  tiredness and washed out feeling lasted approximately 5 days.
This spontaneous report as received from a registered pharmacist refers to a female patient of unknown age. On 24-JUL-2013, the patient was vaccinated with a dose of VARIVAX (Merck) (Lot # not reports) instead of ZOSTAVAX. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Fever, cough, aching ear and throat, urine infection (the first 4 days).  Then I got tremors, nervousness, confusion, hallucination, stomach ache and nausea (1 week).  But I still have nervousness, nausea and stomach ache.
I received the J&J vaccine May 14th.. May 20 I started with severe ear pain. (thought I was getting a ear infection) was leaving May 21st for another state.  On Saturday May 21st, I was driving and I said to my husband, "I can't feel half my face" I went to take a drink and it went down the front of me. I couldn't shut my eye, my face was drooping, can see out of my eye but everything is blurry, I had sharp pains behind my ear and a ear ache and my speech was slurred.  I waited to call my doctor back home on Monday morning. I was scared  had no idea what was happening to me. Monday was also my birthday.  She ordered me to go to the ER as she thought maybe I had a stroke. So I spent my birthday in the ER. They did a CT scan, x-rays, bloodwork and EKG.  They ruled out a stoke. The dr. said I had Bells Palsy, "it is a known side effect to the covid vaccine" and should go away within 2 days to two weeks. He prescribed Acyclovir and Prednisone and Symptoms seemed to get worse. The sever pain behind my ear was horrible. The dr. told me I could up my Gabapentin to 4-6 pills a day for the pain. We cut a vacation short by a couple of days because I wanted to see my doctors back home for the pain.  It wasn't normal! I seen my doctors and they sent me for more bloodwork thinking maybe it was Lyme's disease. Did that and that was negative. Then ordered a MRI to see if anything was wrong.  It came back that I had Bells palsy, I also have a enlarged lymph node and inflamed nerve.  She then recommended my to a Neurologist. The Neuro doctor ordered another MRI for a couple of week ahead as well as a CT scan of the chest, told me to see a eye doctor, and more bloodwork. I have seen a eye doctor and she says it's normal for me to have blurred vision with Bells palsy and my vision should eventually come back. My regular doctor also added a CT scan of the abdomen area to rule out cancer or anything else. Both the CT scans came back normal for my age, no cancer cells. The MRI came back the same as first one. On July 19th I had a Spinal Tap. I'm still awaiting all the results.  As of today, I still have slurred speech, blurred vision, I get tired fast, have no energy, my pain behind the ear comes and goes. When my pain is real bad my speech worsens, still have a droopy face but not as bad as it was. I get dizzy to the point I feel like I'm drunk. I spend half of the day in bed because I can't move, I have had what the neurologist says is "blackout pain" Where the pain is so sever your body just shuts down and I can't move. I've had to have my daughter or husband help me up because I have no strength to move. This is all so scary for me, stressful. I am emotionally, mentally, physically drained! I am not working.
Child had both Varicella and MMR II on right thigh on 4/19/15. Mom noticed a few papules over the area where the vaccines were given on 5/8/15. Initially they were scanty non-erythematous papules and were very itchy and pt. was scratching them. Later papules spread to face and extremities but not the trunk. Since then most have disappeared.
PATIENT'S ARM WAS VERY SWOLLEN. ADMINISTRATION SITE WAS RED AND AS BIG AS A SOFT BALL IN DIAMETER SIZE. THE SKIN WAS ELEVATED AND WARM TO THE TOUCH.
Stomach cramping; Diarrhea; Queasy stomach; Head felt uncomfortable; headache at top of head; Dehydration; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ABDOMINAL PAIN UPPER (Stomach cramping), DIARRHOEA (Diarrhea), ABDOMINAL PAIN UPPER (Queasy stomach), DEHYDRATION (Dehydration) and HEAD DISCOMFORT (Head felt uncomfortable) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced DEHYDRATION (Dehydration). On an unknown date, the patient experienced ABDOMINAL PAIN UPPER (Stomach cramping), DIARRHOEA (Diarrhea), ABDOMINAL PAIN UPPER (Queasy stomach), HEAD DISCOMFORT (Head felt uncomfortable) and HEADACHE (headache at top of head). The patient was treated with LOPERAMIDE HYDROCHLORIDE (LOMOTIL [LOPERAMIDE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, ABDOMINAL PAIN UPPER (Stomach cramping), DIARRHOEA (Diarrhea), ABDOMINAL PAIN UPPER (Queasy stomach), DEHYDRATION (Dehydration), HEAD DISCOMFORT (Head felt uncomfortable) and HEADACHE (headache at top of head) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  The patient's stomach still felt a little queasy and went to emergency room due to dehydration.
Pt reported hearing loss  and tinnitus in her left ear 3 days after receiving the 2nd covid vaccine
Pt recvd vax 18MAR93 & 19MAR93 pt devel blisters in mouth & vaginal area w/vaginal itching; No further details were provided;
A few hours later, I got a migraine.  Over night I got achy and nausea set in. My migraine got worse the next day. Today it is mild but still there. As well as my stomach nausea. I hope to be symptom free by tonight. I also had muscles tighten up. Especially in my legs
ill; Initial information was received on 03-Oct-2021 regarding an unsolicited valid non-serious case received via social media from a consumer/non-health care professional . This case involves a patient (unknown demographics) who had ill (illness) after receiving INFLUENZA VACCINE.  It was unknown if the patient had any medical history, concomitant disease or risk factor.  Medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On an unknown date in 2006, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiry not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date in 2006, the patient developed a non-serious ill (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "Only time I had was 2006 and the first time ever I was ill - never again."  It was unknown if the patient experienced any additional symptoms/events.  There were no lab data/results available.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome of the event was unknown.  There will be no information available on the batch number for this case.
Throat pain; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Throat pain) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     Concomitant products included FISH OIL (OMEGA 3 [FISH OIL]) and VITAMINS NOS for an unknown indication.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, the patient experienced OROPHARYNGEAL PAIN (Throat pain). The patient was treated with AMOXICILLIN on 11-Mar-2021 at an unspecified dose and frequency. At the time of the report, OROPHARYNGEAL PAIN (Throat pain) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
2nd Shot, 2nd day headache, bad muscle ache, third day slight headache redish injection site, fourth day bad headache, indigestion and bad diarrhea. Injection site large red, purple, orange (size 2-1/2 " x 1-1/2" very sore.  Today, 3/5; reaction site sore but brusing fading. Feel good.    1st Shot was slightly sore arm.  Never had fever, cough, chills or vomitting.  *** DID NOT CONTACT DOCTOR; WAS NOT EMERGENCY. Just felt like I had flu but thought I should report bad arm reaction.
conjunctival injection chest heaviness/SOB sx13 improved with antihistamine, pt doing well. Vaccine was given & site other than this office. Patient was evaluated here after 1 day vaccine was given. Manufacturer and lot number unable to obtain. This into was given on original report.
was bed ridden for 2 days afterwards; may have received the high-dose; Initial information received from on 14-Feb-2022 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves an adult female patient who was bed ridden for 2 days afterwards and may have received the high-dose, after receiving vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].     The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On an unknown date, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (strength, dose, formulation: unknown) with lot UT7347LA via unknown route in unknown administration site as prophylactic vaccination. It was reported that patient was bed ridden for 2 days afterwards, so she was concerned she may have received the high-dose ((extra dose administered). Patient was asking whether the lot of UT7347LA a FLUZONE was, or FLUZONE HIGH-DOSE VACCINE. Caller reported her clinic stated they administered FLUZONE VACCINE. Advised caller to contact clinic to gather NDC. Marked as potential to submit to Quality team to see if they were able to look up that information. Caller was frustrated that she could not locate the product via the lot number only, therefore, caller disconnected and said she had call back another time.  Action taken with INFLUENZA VACCINE TRIVALENT (FLUZONE HIGH DOSE) was not applicable.  It was not reported if the patient received a corrective treatment for the events   At time of reporting, the outcome was Unknown for the events     This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
raised, itchy nodules in circular area approx 6 cm at injection site developing into mildly itchy, red, warm, induration in same area resolving over two days.  Occurred on day 10 after injection