chrisvoncsefalvay/vaers-outcomes huggingface dataset:
body aches; swollen lymph nodes under left arm, under chin, and by left hip bone; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (body aches) and LYMPHADENOPATHY (swollen lymph nodes under left arm, under chin, and by left hip bone) in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, the patient experienced MYALGIA (body aches) and LYMPHADENOPATHY (swollen lymph nodes under left arm, under chin, and by left hip bone). At the time of the report, MYALGIA (body aches) and LYMPHADENOPATHY (swollen lymph nodes under left arm, under chin, and by left hip bone) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Treatment related information was reported.
24 hrs after vaccine, pt started with erythematous, indurated 6 x 6cm round papule. Was sore and warm to the touch.  pt was advised to use cool compress and use allergy medication or lotion for itching. Spot was measure with skin marker to monitor the next day
10.5 hours after receiving SHINGRIX vaccine patient was awaken out of sleep C/O HA, Fever, Chills, and swelling on nose and upper lip. The next day (approximately 24 hours after vaccine) she had blisters on upper lip, nose, and buccal mucosa. Patient states she took TYLENOL 500 mg 1 tablet PO each day since symptoms started.
Heart Rate low 40's (Brady Cardia); Chest Pain; Lung Pain; Difficulty Breathing; High Blood Pressure; Fatigue; Major Weakness; Oxygen low 80's; Light Headed, Dizzy; This is a spontaneous report from a contactable consumer (patient). A 47-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 03Apr2021 (Batch/Lot Number: EW0150) (at the age of 47 years) as DOSE 1, SINGLE, dose 2 via an unspecified route of administration on 24Apr2021 (Batch/Lot Number: EW0169) (at the age of 47 years) as DOSE 2, SINGLE for COVID-19 immunisation. Patient was not pregnant at time of vaccination. Medical history included Excessive Factor 8, Seasonal Allergies, Known Allergies: Penicillin, Gluten sensitivity, Inteferon Gold. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19 (negative). Concomitant medications included apixaban (ELIQUIS) taken for an unspecified indication, start and stop date were not reported; colecalciferol (VITAMIN D 3) taken for an unspecified indication, start and stop date were not reported. The patient experienced Chest Pain, Lung Pain, Difficulty Breathing, High Blood Pressure, Fatigue, Major Weakness, Oxygen low 80's, Heart Rate low 40's (Brady Cardia), Light Headed, Dizzy, on Apr2021. The patient underwent lab tests and procedures which included blood pressure: high on Apr2021, heart rate: low (40) on Apr2021, oxygen saturation: low (80) on Apr2021, sars-cov-2 test: negative on Apr2021 Nasal Swab, sars-cov-2 test: negative on May2021 Nasal Swab. Events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Disability or permanent damage. Treatment included Antibiotics, Oral Steroids, Steroid Inhalers. The outcome of events was not recovered.
no adverse event---just report mixing error --multi diluent vial used more than once to mix with covid vaccine
WE CONTACTED PFIZER. THERE WERE NO SIGN AND SYMPTOMS BROUGHT TO OUR ATTENTION BY PATIENT.
Started with pins and needles in hands and feet. Over a period about 10 weeks other symptoms began to appear. These included strange paresthesia's all over the body, burning sensations, cold sensations, tinnitus, joint pain, random muscle aches and pains, toe cramping/curling, spasms and tightness, banding sensation on toe, and numb sensations on feet/toes. After the 10 weeks, symptoms are slowly getting better. 4 months out from the start I am still experiencing some tinnitus, desensitized area where the numbness was on my big toe, and occasionally joint pain.
Chills, fever, headache, nausea, vertigo, joint stiffness, mild hallucinations, fatigue. Most symptoms subsided within 24-hours but headache, vertigo and nausea lasted about two days.
fever of 101 began 4/6/2023  and rash developed 4/7/2023, day 8 after MMR vaccine. rash appeared on face and trunk, raised erythematous wheals. mom reports rash is transient and is associated with the fever. she does notice it improved with hydrocortisone cream, but returned when fever spikes. there is associated pruritis with the rash- patient continues to rub his hands together. treated with oral prednisone x 3 days for pruritis. mom giving oral zyrec to treat pruritis as well.
Patient got his second dose of Moderna at the drive through clinic. He was a vehicle passenger and received the vaccine in his right arm. Patient stated he had no known allergies and was a 15-minute observation. At 11.30 am I was notified by (observation staff) that a man was having difficulty and not feeling right. I immediately grabbed my emergency bag and ran to the vehicle identified. On getting to Pt, he stated he had severe pain centrally just below his sternum. He said he felt like he was gasping. I asked him to take a few deep breaths, he took two breaths and said he felt those were ok. His pallor was pale with red streaks on his neck and side of his face. His pulse at 11:33 am was 96 beats per minute. Staff instructed to call 911. Safety director called 911 at 11:33. His pain was worsening, and he stated he didn't feel right and that his arms were tingling. I continued to monitor the Pt. Pulse at 11:34, 120 beats per minute, his pallor was worsening and the red streaks on his face had increased, when asked he stated it was becoming harder to breath and his tongue felt funny, his lips had noticeable swelling at this point. At 11:35 I administered Epinephrine 0.3 mg via autoinjector into his right thigh. At the same time the EMS fire truck pulled into the parking lot and the EMT from the truck advised me that rather than give him the 50mg of IM BENADRYL, they would give him 25 mg IM and 25mg IV. Right at that time the ambulance arrived. I advised the paramedic that I had given the patient IM Epinephrine via autoinjector but had held off on the BENADRYL at the request of the fire truck EMT, and the that they would give him BENADRYL. They paramedics took over the patients care and transferred the patient to the ambulance. The paramedic asked for the spent epi pen, so I gave it to him. The patient remained conscious throughout and was transferred to ER via ambulance.
Mouth ulcers located inside of lip and under tongue; Thrush in mouth; This is a spontaneous report from a contactable consumer (patient). A 49-year-old (non-pregnant) female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VAC-CINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of ad-ministration administered at left arm on 28Jan2021 09:00 PM at single dose for COVID-19 immunisation. Patient also received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration administered at left arm on 22Feb2021 04:30 PM at single dose for COVID-19 immunisation. The patient medical history included asthma and possible lupus. There were no known allergies. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. Concomitant medications (medications the patient received within 2 weeks of vaccination) included cannabidiol (CBD OIL), montelukast sodium (SINGULAIR), montelukast (MONTELUKAST), colecalciferol (VITAMIN D [COLECALCIFEROL]). On 30Jan2021, the patient experienced mouth ulcers located inside of lip and under tongue, thrush in mouth. Occurred 2nd day after the first shot. Started medication and was under control. Flares up again 2nd day after 2nd shot. The patient was not diagnosed with COVID-19 prior to vaccination and patient was not tested for COVID-19 since the vaccination. Patient received clotrimazole 10mg tablets as treatment for event. Outcome of event for mouth ulcers located inside of lip and under tongue was not recovered and for thrush in mouth it was recovering.  Information on the batch/lot number has been requested.
Red and hot band on left arm, with swelling for 9 days. Also extended to underarm are to the point that arm was immobile due to the swelling. Didn't have any fever.
This case was reported by a pharmacist via call center representative and described the occurrence of general body pain in a 73-year-old female patient who received SHINGRIX (batch number 9NJ59, expiry date 8th February 2021) and (batch number 97H72, expiry date 8th February 2021) for prophylaxis. Concomitant products included SHINGRIX. On 24th July 2018, the patient received the 2nd dose of SHINGRIX. On 24th July 2018, the dose was an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced general body pain, cramp, headache and diarrhea. The patient was treated with metronidazole. On an unknown date, the outcome of the general body pain, cramp and headache were unknown and the outcome of the diarrhea was recovered/resolved. It was unknown if the reporter considered the general body pain, cramp, headache and diarrhea to be related to SHINGRIX. Additional details were provided as follows: This case was reported via chat. The patient received 1st dose of SHINGRIX on 25th April 2018. The healthcare professional reported that after receiving 2nd dose, the patient developed a very severe reaction. She had severe body aches, diarrhea for about 48 hours, severe cramping, and a severe headache. She did end up going to the doctor and they gave her Metronidazole for 2 weeks for the diarrhea and cramping, and did additional tests for irritable bowel syndrome (IBS). She said she had a reaction to the first shot, but it was much more severe with the 2nd dose and she had just gotten back from a trip. On the first one she thought that was the underlying reason. Lab Comments: In 2018, the test for IBS was performed.
This initial spontaneous case, was received on 22-Sep-2017, from other health professional, concerning a 25-year-old, adult, male patient. The patient's medical history and concomitant medications were not reported. On 21-Sep-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: less than 0.5 ml (as reported), route of administration: intramuscular, batch number: 00144621A, expiry date:31-May-2018, anatomical location: not reported). It was reported that the patient was administered the vaccine with a 0.5 inches needle (explicitly considered as wrong injection technique), hence possible received only a partial dose (explicitly considered as incomplete dose administered). It was reported that, the patient had not experienced any adverse event. The reporter considered the events as non-serious. Follow-up received on 25-Oct-2017: The additional event (no adverse event) was added. It was reported that, the patient had not experienced any adverse event. The narrative was amended accordingly.
Heart failure sent to ICU; legs swelled; had high blood pressure and her legs swelled; This spontaneous case was reported by a patient and describes the occurrence of CARDIAC FAILURE (Heart failure sent to ICU) in a 70-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.     Concomitant products included SIMVASTATIN, ACETYLSALICYLIC ACID (BABY ASPIRIN) and FISH OIL for an unknown indication.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced CARDIAC FAILURE (Heart failure sent to ICU) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced PERIPHERAL SWELLING (legs swelled) and HYPERTENSION (had high blood pressure and her legs swelled). The patient was hospitalized from 11-May-2021 to 14-May-2021 due to CARDIAC FAILURE. At the time of the report, CARDIAC FAILURE (Heart failure sent to ICU) had resolved with sequelae and PERIPHERAL SWELLING (legs swelled) and HYPERTENSION (had high blood pressure and her legs swelled) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Apr-2021, Blood pressure measurement: high (High) high.         Treatment medication was not provided.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 30-Jun-2021: ADR form received: Suspect drug details updated, Concomitant  medications added, New serious event added, event details updated; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Patient's wife called the pharmacy on 10/23/18 stating that the patient experienced fever, chills and upper lip swelling on the day of the immunization. The fever and chills resolved however the patient stated that his lip still felt swollen. Wife stated that his lip didn't appear swollen to her visually.
The morning after the vaccination was given- I had confusion, fatigue, swollen arm at injection site, elevated blood pressure, elevated heart rate, Disorientation, Extreme pain in left arm where injection was given that sharply radiated throughout the rest of the arm.
Patient received the vaccination and within 5 minutes began to feel a frontal head ache and sensation of palpitations without chest pain or SOB. During evaluation he reported significant improvement of sensations/symptoms but medic obtained EKG and he was then advised to be transported to ED for full evaluation.
red lump on arm where injected . its hot and swollen . the next day after the shot I had a fever , muscle and joint aches and pains . exhaustion . the red lump grew and is still with me 2 weeks after the shot .
Redness, swelling, and warmth at injection site.  Treated with cool compress with some reduction in symptoms.
At 6:25pm after patient received vaccine EMT observed patient appeared pale with her eyes closed.  Medic walked over to patient in which patient informed that, "I don't feel good, I feel nervous and dizzy."  Medic took patient to medic area where vital signs were done and water was given.  After 15 mins. patient recovered.
Patient awoke at approximately 1:50 AM experiencing sever chilling with rigors.  Vomited once . Took temperature, wrapped in blanket and took two Tylonol tabs with water.    Episode lasted approximately 40 minutes.  Has experienced no further episodes and temperature has remained normal.
Since immunizations: Fever 102 yesterday, 100.5 this AM (no meds this AM). Increase in stool output. Blood in stool - flecks on day of vaccines, approximately 1 tsp today. Stool Guiac (+) in office. Feeding well, acting well. Nl PE (no s/s intussusception).
her left arm and is hot to the touch; Sore arm; Red circle in the size of coin at her left arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (her left arm and is hot to the touch), PAIN IN EXTREMITY (Sore arm) and VACCINATION SITE ERYTHEMA (Red circle in the size of coin at her left arm) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (her left arm and is hot to the touch), PAIN IN EXTREMITY (Sore arm) and VACCINATION SITE ERYTHEMA (Red circle in the size of coin at her left arm). At the time of the report, VACCINATION SITE WARMTH (her left arm and is hot to the touch) and VACCINATION SITE ERYTHEMA (Red circle in the size of coin at her left arm) outcome was unknown and PAIN IN EXTREMITY (Sore arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.   No treatment information was provided.
Post-vax the patient had swelling of the right leg from the ankle to the thigh and also a red rash over the entire right leg. The patient had soreness of the right thigh and was treated with Tylenol.
Patient received Pfizer vaccine after previously receiving Janssen vaccine back in March.  Patient identified on their consent form that they HAD NOT previously received a COVID-19 vaccine and this is why dose 1 of Pfizer was administered.  I only found out about the previously vaccine when I billed Medicare at the end of the day,
4 hrs p/vax pt suddenly went limp in mom arms-lasted 10 mins; pt was pale, hot, later diaphoretic; no sz activity; came into clinic afterwards, exam completely nl; no further episodes;
Pt's mom reports that approximately 2 hours, post vax, pt had excessive crying which lasted 5 hours. Pt had no fever, no redness or swelling at injection sites (legs) but some bruising at injection sites, were observed. Mom did not notify clinic until 3/17/2000.
Area became red 24 post injection, then 48 hours later area red and very hot.
lot 042J21A should have been reported with a BUD of Feb 17, 2022.; No adverse event; lot 042J21A should have been reported with a BUD of Feb 17, 2022.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (lot 042J21A should have been reported with a BUD of Feb 17, 2022.), PRODUCT STORAGE ERROR (lot 042J21A should have been reported with a BUD of Feb 17, 2022.) and NO ADVERSE EVENT (No adverse event) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042J21A and 939902) for COVID-19 prophylaxis.     No Medical History information was reported.   On 08-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (lot 042J21A should have been reported with a BUD of Feb 17, 2022.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (lot 042J21A should have been reported with a BUD of Feb 17, 2022.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (lot 042J21A should have been reported with a BUD of Feb 17, 2022.), PRODUCT STORAGE ERROR (lot 042J21A should have been reported with a BUD of Feb 17, 2022.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (lot 042J21A should have been reported with a BUD of Feb 17, 2022.) and PRODUCT STORAGE ERROR (lot 042J21A should have been reported with a BUD of Feb 17, 2022.).    Concomitant products were not provided. Treatment medication were not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-704416 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 24-Jan-2023: Follow-up contains no new information.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704416:Master case
lymph node inflammation on side of injection after third dose, fever, chills, vomiting and diarrhea after both doses
Mother called at approximately 4 PM and stated that child started vomiting this morning. Child had vomited 4 times and mother states that chile appears pale and c/o of anorexia, nausea and abdominal pain.
Light headache off and on for 12 days. Chills came off on on for the first five days, then subsided but a swollen/painful lump in my right inner cheek appeared. That lasted five full days and was accompanied by light tingling at times. When that started to subside, the chills and light headache returned. I finally have no symptoms except the red mark on my arm at the injection site.
Shortly after the vaccine my face started having a burning sensation and started turning red.  The next morning it was more intensivied and my face had swollen all over.   I never developed a fever and was advised to take benedryl to help with the  swelling and it took about 4 days for the swelling to diminish. I had injection site soreness as well
Started around August, my menstrual cycle started to get longer and heavier, my initial thought was my INR must be high. Lab results  (for INR) came back in therapeutic range.  The hormonal menstrual cycle disruption continued causing my Hemoglobin to drop which was of concern to my Rheumatologist.  She then suggested a visit to my OB/GYN. Upon doing so I had a full pelvic exam and a Uterine Biopsy to rule out STI and Gynecological Cancer. All results came back negative. The menstrual disruption continued, getting longer and heavier. Now I'm passing large clots, so big it feels as though I'm having a contraction every time one passes.
54 YO VA F REVACCINEE 10 WEEKS POST VACCINATION PERSISTENT SCAB, 2-3MM; MAJOR REACTION WITH NORMAL PROGRESSION, CLINICALLY STABLE; NO HISTORY OF WOUND HEALING PROBLEMS, IMMUNODEFICIENCY; WORKING DX: PERSISTENT SCAB UNDER INVESTIGATION
Headache, rash, itching and pain in rash area on lt side of face, left arm, midline epigastric area, neck. Residual rash after 1 week.
PT had redness of the left shoulder. She was told to apply a wet warm compress and to take Claritin, Benadryl, and Pepcid daily.
7.5 days after receiving my first dose I started breaking out in hives all over my body. I had not eaten any unusual foods or used any unusual products on my skin. Huge hives all over my body. My itching was uncontrollable. About 1-2 days later my entire body was sore and got progessively worse throughout the day. I could not move without being in pain. Even when I wasn't moving my body was aching all over.  The rheumatologist said it could be reactive arthritis from the vaccine. Over a month later, to this very day I still break out into hives and get extremely itchy all over my body and have slight joint paint, particularly in my fingers. I have been told to take Allegra which helps a bit. After taking Allegra I still get a few hives and redness on my body that isn't itchy but still present. However once the Allegra wears off I am extremely itchy.
Sm described area as a "red knot" looks like a pimple and the area is "itchy." Received Gardasil on 9/10/07. Saw provider who stated this was a mild allergy. Benadryl to be taken.
pt returned to clinic c/o pain rt elbow starting 3 days p/MMR vax given; no other complaint;