chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Tongue was sore; Blisters inside mouth; Gums were swollen; Chills/Shivering; Was feverish; Very tired/slept all day; This spontaneous case was reported by a consumer and describes the occurrence of GLOSSODYNIA (Tongue was sore), ORAL MUCOSAL BLISTERING (Blisters inside mouth), GINGIVAL SWELLING (Gums were swollen), CHILLS (Chills/Shivering) and PYREXIA (Was feverish) in a 60-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 information was reported.    On 08-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Oct-2021, the patient experienced CHILLS (Chills/Shivering), PYREXIA (Was feverish) and FATIGUE (Very tired/slept all day). On 11-Oct-2021, the patient experienced GLOSSODYNIA (Tongue was sore), ORAL MUCOSAL BLISTERING (Blisters inside mouth) and GINGIVAL SWELLING (Gums were swollen). On 10-Oct-2021, CHILLS (Chills/Shivering), PYREXIA (Was feverish) and FATIGUE (Very tired/slept all day) had resolved. At the time of the report, GLOSSODYNIA (Tongue was sore), ORAL MUCOSAL BLISTERING (Blisters inside mouth) and GINGIVAL SWELLING (Gums were swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported by the reporter. No treatment was reported by the reporter.
Pt. reports shakes, dizziness, sweating. Pt.'s skin is warm and B/L arms pink in color. Patient mildly anxious.
This spontaneous report has been received from a medical assistant via a company representative referring to an approximately 17-year-old male patient. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not reported. On an unknown date, the patient was vaccinated with the first dose of GARDASIL 9 (strength, dose, route, anatomical location, lot number and expiration date were not provided) for prophylaxis. Approximately in February 2018 (reported as "in February 2018 or March 2018") the patient was vaccinated with the second dose of GARDASIL 9 (strength, dose, route, anatomical location, lot number and expiration date were not provided) for prophylaxis.  Other suspect therapies included TRUMENBA. It was reported that immediately after vaccination, the patient fell off the bed and had a seizure. The patient was monitored at the physician's office for an unspecified period of time and then was sent to the emergency room. It was also mentioned that the patient had a cut above the eyebrow which was "glued" (face injury). On an unspecified date in 2018, a computed tomography (CT) of the head was performed which was normal. On an unspecified date in 2018, a follow up with the physician documented the patient was fine. At the reporting time, the outcome of seizure, fall and face injury was reported as resolved. The causality assessment between therapy with GARDASIL 9 and the events was not reported. Upon internal review, the seizure was determined to be medically significant.
I developed a sudden onset of heart palpitations and went to the ER to find I was in Atrial Fib with RVR. Heart rate 166 upon arrival to the ED.
12/31/20 Severe Brain Fog. Several events, but mainly administering wrong meds to wrong person at work. In 26 yrs. had never done that & wrote an med error due to vaccine. 1/3/21 Felt like I had been hit by a truck. Pain in rt side, back & shoulders. Not able to sleep. Called boss - had over 300 hrs of sick leave. 1/5/21 Saw Dr at clinic. 1/5/21 Dr - clinic - Had pneumonia in rt lung (X-ray) Possible blood clot - Lab - CT scan - 3 blood clots in rt. lung. Gave me muscle relaxer for back spasms & shot for pain. Returned to ER for 2 shots in stomach for blood clots. 1/6/21 Began taking Eliquis (blood thinners). 1/8/21 Back to clinic - pain - P.A. - pain pills. 1/9/21 Decided to sleep in recliner knew I could not make it out of bed. Was using ice & heat on my back & left knee was swollen. At 4:00 a.m. realized stuck in chair. Called daughter-in-law 1/10/21 to take me to ER. Saw PA. X-rays chest & Lft. (Knee (normal wear & tear). More pain pills & shot. Went to stay w/ my son & wife. Borrowed a walker and had to be assisted to bathroom. 1/12/21 Worse headache & neck pain. Requested trip to ER I held my head the 40 miles to hospital & my left knee was swollen double.  Admitted to Medical Center. Had Covid & Flu test (both negative) Another CT scan. Gave me steroids and leg (knee) was fine by Wed. I was put on Oxygen and was sent home w/ 4 tanks. Remained on blood thinners. I remained w/ my son & wife for a few days. Still had some brain fog after arriving at my home. 4/9/21 I saw Dr. Tested my cholesterol as he took me off statin and putting me on another drug. I am continuing to take blood thinners. Plan to return 2 oxygen tanks. Will not take the 2nd vaccine. The County Health Nurse who gave me the vaccine refused to submit the reaction. She called me and my daughter in law called her when I went into the hospital. Later she told me my provider had to report it.
16 year old received the first dose vaccine; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old received the first dose vaccine) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-May-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old received the first dose vaccine). On 04-May-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old received the first dose vaccine) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication were reported. No treatment medication were reported.
Approximately 36 hours after injection (at 3am on 2/2/2021) I woke with fever of 100 degrees F, shivering and chills, headache, and the injection site was extremely sore. Prior to this time all of my symptoms had been very minor. I am submitting this because of the long timespan between injection and onset of discomfort.
Received HD injection, next day had high blood pressure, tinnitus, nausea, headache. Went to E.D. Had CBC, CMP, UA, TSH, Head CT, EKG. Discharged. To PCP for follow up 10/9/14 feeling baseline again. Rx Potassium and magnesium replacement.
red arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (red arm) 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 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (red arm). At the time of the report, VACCINATION SITE ERYTHEMA (red arm) outcome was unknown.            No concomitant medication details was reported. No treatment medication details was reported.
Breakthrough case of COVID-19: I did a telehealth visit with the doctor and was prescribed Benzonatate for coughing.  Monoclonal antibodies (04/18/2022).
11/20/05 - V/D/ lethargy. Rash 12/11/05 pink, blanching, macukar rash over torso only. Discreet well demariated lesions. LGF ( tx = zyrtec .5 tsp )
7 days after injection developed itching, swelling and pain with possible fluid collection at the injection site.
Presents for SOB & hypoxia (dx w/COVID at outside facility). Admit for COVID pneumonia. Tx: O2 via NC, vit c, vit d, zinc, decadron, abx. DC to home.
This sponatenous report as received from a consumer refers to her mother, a 69 years old female patient with high cholesterol and amoxicillin and ampicillin allergy. The patient was vaccinated in the left arm with dose 1 of PNEUMOVAX23 (lot number unspecified) on 26-JUN-2012. On 17-DEC-2012 the patient was vaccinated in the left arm with a second dose of PNEUMOVAX (lot number unspecified). Route was not reported. No other co-suspects were reported. Concomitant medications included: CRESTOR. The patient was vaccinated with 2 doses of PNEUMOVAX 23 with in 6 months time. After the first dose the patient had no adverse event. Post vaccination of the second dose on 17-DEC-2012, the patient went home and developed soreness, 3 inch diameter circumference around the left arm, and swelling down to the left elbow, and fever of 100.5. The reporter called her mother's physician on 18-DEC-2012 and TYLENOL and cold compress for left arm were recommended. The patient did not take the TYLENOL. The patient was seen by the doctor and as told that she may have an abscess at the injection site. The physician recommended ciprofloxacin, but the reporter stated she does not think her mother should take the medicine, as she does not need it. The reporter stated that her mother's left arm still hurt, the swelling was going down, but it looked like she was getting better. The reporter did not provided a causality assessment. Additional information is not expected.
4/28/2021- Patient presented to ED for evaluation after a syncopal episode with fall and head injury, severe headache; loss of consciousness; bradycardia with early repolarization without acute ischemia.  6/3/2021- continued confusion, disorientation; Brain MRI shows early chronic infarct  6/14/2021- Patient presented with continued syncopal episodes, significant confusion ongoing for weeks, diagnosed with large left MCA stroke.
My daughter got full hives within three hours of receiving the FLU shot at her pediatricians office. She had raised red, blotchy hives on her face and neck, and sand-paper like rash on the rest of her body. We called her Peds office and got the o/c doctor and was instructed to watch her and give her Benadryl.
This case was reported by a healthcare professional and described the occurrence of redness in a 4-year-old female subject who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix, GlaxoSmithKline) for prophylaxis. There was no relevant medical history. The subject's concurrent conditions were not reported. Concurrent vaccinations administered on 19 September 2006 included hepatitis A vaccine (Havrix, GlaxoSmithKline) and live attenuated oral poliomyelitis vaccine (Aventis Pasteur). Concurrent medications included "vitamins". On 19 September 2006 at 15:20 the subject received 4th dose of Infanrix (0.5 ml, intramuscular, left arm). On 19 September 2006, less than one day after vaccination with Infanrix, the subject experienced 14 x 14 area of redness and 14 x 14 area of swelling. At the time of reporting the events were unresolved. The healthcare professional considered the events were probably related to vaccination with Infanrix. Follow-up information received on 23 October 2006 indicated that the subject developed dermatitis and the onset date for the event and symptoms was actually 21 September 2006. The outcome of the events was not known and the reporter stated that the events were related to treatment with Infanrix.
Information has been received from a medical assistant referring to a 6 month old female patient. No adverse effects were reported. This is one of several reports received from the same reporter. Original report is MARRS#1507USA011322. Additional information has been requested.
This particular event months after the injection was bronchitis.  Tired, feverish, coughing up phlem, fatigue
Moderna Covid019 Vaccine EUA Vaccine found to be out of date after administration on 8/4/21.
Nausea Diarrhea Headache Joint pain Chills Fever Sore throat Dry cough Muscle pain Fatigue Mood swings & crying spells Diabetic sugar fluctuations  Now this rash - one week & 3 days later
Severe swelling in both legs to the point that my feet felt like they were going to burst.  Received injection on Wednesday, symptoms started Saturday, went to doctor on Monday.  Doctor did bloodwork and check all my levels - they were good.  He treated the symptoms with anti-inflammatories and fluid pill.  Still swollen but not as bad.
1 of 3 pts recvd vax via lederject from the same lot which resulted in inj site rxn w/in 24hrs;rxn consisted of erythema, swelling, pruritus, & pain from shoulder to elbow requiring MD visit;tx atarax
flu-like symptoms; felt like asthma or a seasonal allergy; felt like asthma or a seasonal allergy; some difficulty breathing; a little bit of cough; itchiness on her thighs; crazy red lines all over her thighs; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (some difficulty breathing), COUGH (a little bit of cough), PRURITUS (itchiness on her thighs), ERYTHEMA (crazy red lines all over her thighs) and INFLUENZA LIKE ILLNESS (flu-like symptoms) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced DYSPNOEA (some difficulty breathing), COUGH (a little bit of cough), PRURITUS (itchiness on her thighs), ERYTHEMA (crazy red lines all over her thighs), ASTHMA (felt like asthma or a seasonal allergy) and SEASONAL ALLERGY (felt like asthma or a seasonal allergy). On 16-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu-like symptoms). At the time of the report, DYSPNOEA (some difficulty breathing), COUGH (a little bit of cough), PRURITUS (itchiness on her thighs), ERYTHEMA (crazy red lines all over her thighs), INFLUENZA LIKE ILLNESS (flu-like symptoms), ASTHMA (felt like asthma or a seasonal allergy) and SEASONAL ALLERGY (felt like asthma or a seasonal allergy) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant information were not reported. Treatment information were not reported.
Swelling at the site of injection about the size of a lemon with warm, red inflamed skin.  Lasted more than 24 hrs.  Very painful.
Approximately day 8 after the vaccine, my left arm near the injection site began to itch.  The next day I noticed a red oval area around the injection site.  It continued to itch.  I purchased over the counter Cortizon-10 and used it three times daily.  After two more days, the itching and redness dissipated.
Rash developed on face after @ one week (At first I thought it was due to wearing a mask for several hours a day._   The rash gradually increased to my hands and feet, later my thighs and shoulders.  The rash on my fingers is very painful and other locations very itchy.  I was dianosed with erythema multiforme and treated with 5 days of prednisone on March 25th.
2/18---dizziness/weakness (CMP, CBC, troponin, TSH, urine, EKG, chest xray)?ED visit.   2/24 traumatic hematoma (possibly from blood draw on 2/18)---xray, Doppler done 6/12 Nausea/vomiting hemocult + blood, maroon/coffee ground consistency, RUQ pain, diarrhea, colorectal enteritis, heparin given as prophylaxis against DVT.  Hemoglobin trending down (14.1 to 11.5), type and screen done in case blood transfusion is needed (when hgb <7), endoscopy;  CT scan showed the following: 1. Multiple regions of small bowel wall thickening and to a lesser extent large bowel wall thickening concerning for a coloenteritis. Differential includes infectious, inflammatory, or ischemic coloenteritis. Recommend correlation with lactic acid levels. No pneumatosis or free air.  2. Small volume ascites. Mesenteric edema.  3. Advanced atherosclerotic change of the abdominal aorta and side branches.
petechiae on her back and abdomen; This spontaneous case was reported by a consumer and describes the occurrence of PETECHIAE (petechiae on her back and abdomen) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (medical history was not provided).    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 PETECHIAE (petechiae on her back and abdomen). At the time of the report, PETECHIAE (petechiae on her back and abdomen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  Treatment details was not reported.
Red, warm, swollen arm, tender at injection site, had begun resolving by time pt contacted office Monday.
But after second dose there is a pocket full of fluid under the injection site.; At a certain light it looks like a may be blueish bruise.; arm was tender/arm was painful; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE VESICLES (But after second dose there is a pocket full of fluid under the injection site.), VACCINATION SITE BRUISING (At a certain light it looks like a may be blueish bruise.) and VACCINATION SITE PAIN (arm was tender/arm was painful) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 028A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included MELATONIN for an unknown indication.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE VESICLES (But after second dose there is a pocket full of fluid under the injection site.), VACCINATION SITE BRUISING (At a certain light it looks like a may be blueish bruise.) and VACCINATION SITE PAIN (arm was tender/arm was painful). At the time of the report, VACCINATION SITE VESICLES (But after second dose there is a pocket full of fluid under the injection site.), VACCINATION SITE BRUISING (At a certain light it looks like a may be blueish bruise.) and VACCINATION SITE PAIN (arm was tender/arm was painful) had resolved.            No treatment information was provided.   This case was linked to MOD21-069291 (E2B Linked Report).  Most recent FOLLOW-UP information incorporated above includes: On 16-May-2021: Added reporter information. Updated the outcome of events.; Sender's Comments:  MOD21-069291:MOD-2021-067565 1st dose case
Two days after receiving her first dose of the COVID 19 vaccine, she had significant swelling on the lateral side of the chest just below the right axilla. She complained of pain in her axilla before the swelling started and was given tylenol and ibuprofen for pain which did not help significantly. After the swelling started, she complained of pain in the area of both the axilla and the chest where the swelling occurred. We used both heat and ice to help it feel better and to help decrease the swelling. The swelling would go down during the night and then become quite significant by afternoon and evening for several days. It took 5-6 days before the swelling  and pain went away completely.
PFIZER COVID VACCINE #3 GIVEN 11/3/21, LOT #FD0809; pt had a positive COVID test on 1/22/22; increased confusion; CXR negative; pt's condition continued to decline; pt in local Hospice where he passed away.
Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Dizziness / Lightheadness-Medium, Additional Details: Patient reported difficulty breathing/throat closing and swelling of tongue 10 minutes after getting the vaccine. I immediately gave Epinephrine 0.3 mg injection and a 25 mg benadryl tablet and called 911 immediately. Patient reported feeling better after 10 minutes. Emergency Medical services arrived within 10 minutes. They checked her vitals and all vitals were normal. Patient refused to be taken to ER and the EMT documented her refusal.
This case was reported by a physician via call center representative and described the occurrence of unexpected therapeutic effect in a elderly female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included post herpetic neuralgia. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced unexpected therapeutic effect. On an unknown date, the outcome of the unexpected therapeutic effect was unknown. It was unknown if the reporter considered the unexpected therapeutic effect to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The reporter was an acquaintance of the patient but did not have her initials, DOB (date of birth) (believed she was in her late seventies or early eighties). The reporter did not have any of the product specific information. The HCP healthcare professional (reporter) reported that a patient with post herpetic neuralgia received a dose of SHINGRIX and subsequently noticed a marked reduction in symptoms and the patient was able to open her hand(s) for the first time in a year and a half. The reporter was eager, however, to provide information to safety and requests that the GSK (GlaxoSmithKline) was sending a form for reporter (or the patient) to fill out.
chest pain and sob one and a half hour later.  evaluated in ED had full work up and not determined to be anaphylaxis.
Case number PHEH2013US014619, is an initial spontaneous report received from a healthcare professional on 03 Jul 2013: This case refers to an 18-year-old female patient. Previously, she was vaccinated with meningococcal vaccine (manufacture and batch number: unknown) in 2009. She received only Men C, Y, W-135 liquid conjugate component of MENVEO vaccine (batch number: X11082 and expiry date: Jun 2014), intramuscularly without being reconstituted with Men A component on 12 Jun 2013. However reporter does not known which of the two patients received only a partial dose of MENVEO. No adverse reaction reported following this administration error.
On 12/14/2004: 12cmx15cm of erythema and induration at injection site left deltoid, increased fever. Personal physician treated patient with blood-work to an antibiotic. Joint pain, nausea, 100.8 degree fever. Patient took the antibiotic (Biaxin) and reported blood in urine next AM. Doctor then ordered lab.
Fever, vomiting and diarrhea evening of day vaccines given; fever and vomiting resolved after 3 days; diarrhea persistent.
DRASTIC CHANGE IN PALLOR, LIPS BLUE, UNRESPONSIVE TO STIMULI OR VOICE, LEGS AND ARMS JERKING WITHIN 5 MINUTES OF ADMINISTRATION. ADMINISTERED EPIPEN IN RIGHT LEG. First Responders came and monitored until EMS arrived. Blood pressure was 87/56.  Condition did improve. Patient waived transport to ED and was taken home by her uncle to be monitored by her grandmother who is a retired RN.
Pt hospitalized 3 wks after getting HPV injection - c/o 3wk Hx groin pain, chest pain - ER EKG, X-ray, labs results Pubicostetis inflammed - 8/23/10.