chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Tingling on her mouth; Body ache; Fatigue; Chills; Throat and mouth felt weird; Shaky; Brain fog; Throat and mouth felt weird; Rapid heart beat; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL DISCOMFORT (Throat and mouth felt weird), NERVOUSNESS (Shaky), FEELING ABNORMAL (Brain fog), ORAL DISCOMFORT (Throat and mouth felt weird) and TACHYCARDIA (Rapid heart beat) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Graves' disease, Vitamin D deficiency and Latex allergy. Concomitant products included THIAMAZOLE (TAPAZOLE), VITAMIN D3 and LORATADINE (CLARITINE) for an unknown indication.   On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Dec-2020, the patient experienced OROPHARYNGEAL DISCOMFORT (Throat and mouth felt weird), NERVOUSNESS (Shaky), FEELING ABNORMAL (Brain fog), ORAL DISCOMFORT (Throat and mouth felt weird), TACHYCARDIA (Rapid heart beat), MYALGIA (Body ache), FATIGUE (Fatigue) and CHILLS (Chills). On 31-Dec-2020, the patient experienced PARAESTHESIA ORAL (Tingling on her mouth). On 31-Dec-2020, OROPHARYNGEAL DISCOMFORT (Throat and mouth felt weird), NERVOUSNESS (Shaky), FEELING ABNORMAL (Brain fog), ORAL DISCOMFORT (Throat and mouth felt weird) and TACHYCARDIA (Rapid heart beat) had resolved. In January 2021, MYALGIA (Body ache), FATIGUE (Fatigue) and CHILLS (Chills) had resolved. At the time of the report, PARAESTHESIA ORAL (Tingling on her mouth) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Dec-2020, Heart rate: (High) 150 beats per minute.     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 treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: Follow-up added on 27-APR-2021, medical history provided, vaccine date updated, second dose details added, new events added
Patient is under age 12 but was given the COVID vaccine for ages 12+. When this was discovered, the parent was called to check in on on the patient. Parent reported arm redness/swelling and more fatigue than previous vaccines. Vaccine was administered on 10/19/23. As of 10/22/23, mom reports the patient is better and symptoms had resolved.
PT HAS BEEN COMPLAING OF CHILS  AND BOYACHES AND CONTINUOUS FATIGUE WHICH  HAS LASTED  UNTIL TODAY
Suddenly had a fever over 99 degrees and developed hives significant in size. The hives would disappear and then reappear on another part of his body, but the hives appeared all over him at once. A single hive could reach the size of one half of his entire leg from hip to ankle.
Pt.'s wife states 06/29/2021 husband received Phizer vaccine 10:00am and then was notified of receiving 6x the normal dosage required @ 11:00am.  No known symptoms presently presently (currently under supervision).
Bright red cheeks; Throbbing; Bad ear ache; had a little bit of a headache; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Bright red cheeks), PAIN (Throbbing), EAR PAIN (Bad ear ache) and HEADACHE (had a little bit of a headache) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     The patient's past medical history included Trigeminal neuralgia since an unknown date. Concurrent medical conditions included Drug allergy, Drug allergy, Drug allergy and Drug allergy. Concomitant products included INSULIN DEGLUDEC (TRESIBA), SEMAGLUTIDE (OZEMPIC), SOTALOL, APIXABAN (ELIQUIS), HYDROCODONE, ATORVASTATIN, CENTRUM SILVER +50 and VALACICLOVIR HYDROCHLORIDE (VALTREX) for an unknown indication.   On 10-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Mar-2021, the patient experienced ERYTHEMA (Bright red cheeks), PAIN (Throbbing), EAR PAIN (Bad ear ache) and HEADACHE (had a little bit of a headache). At the time of the report, ERYTHEMA (Bright red cheeks), PAIN (Throbbing), EAR PAIN (Bad ear ache) and HEADACHE (had a little bit of a headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Mar-2021, Body temperature: high Farad (High) Temperature of 101 F.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.
Noted soreness in RT shoulder am of 21st. Then developed 102 fever, body aches, swelling, noted shoulder size increased size of "baseball", redness developed - spreading down to RT elbow. Dev. nausea and vomited on 22nd. Felt fatigued/miserable. Used ice/head on shoulder as palpable "hard" spot. Noted evening 23rd area decrease 2 redness down to elbow. Returned to clinic on 24th with symptoms currently.
AIDP, NMO, TM, DEVIC - symptoms started 12/2012 after flu vaccine. Immune therapy treatments is on going.
1AUG91 1AM by mom's report pt awakened, tried to get up but couldn't; noticed exaggerated shaking; Lasted approx 2 min; Fell on floor getting out of bed;
This case was reported by a nurse and described a 33 year old male patient who did not respond to the Hepatitis B vaccine recombinant immunization series.  On an unspecified date in 2002 or 2003, the patient received the third dose of Engerix-B.  Approximately 6 to 12 weeks later a Hepatitis B surface antibody titer was negative.  The nurse stated that "All injections were given intramuscularly in the deltoid muscle with a 1 inch needle.  All vaccine is refrigerated and the temperature is monitored daily.  The nurse considered the event to be probably related to vaccination with Engerix-B.
Patient said she felt a nerve type when right after the shot. She stated the pain started in her neck and went into her head and then down her back and to her rectum and felt like it was pulling her down and her legs became very heavy.
This spontaneous report was received from a doctor of pharmacy refers to a 69-year-old male patient with no pertinent medical history and drug reactions/allergies. On 15-OCT-2012 the patient was vaccinated with 0.5 milliliter (ml) PNEUMOVAX 23 (lot # 1947AA), expiration date 20-OCT-2013) intramuscularly (IM). Concomitant medications included unspecified blood pressure medication. Patient experiencing stinging, soreness and pain at the injection site after receiving PNEUMOVAX 23 on 15-OCT-2012. Pharmacist also reported that the patient stated that he had been experiencing cramping in the left arm where he received the injection of PNEUMOVAX 23 and that the cramping moved down from his shoulder to his hand and is described as quick cramps or a twitching feeling. No treatment was given for the events. No lab diagnostic studies were performed. The patient sought medical attention by contacting the pharmacist. The events did not resolve at the time of this report. No further information is available. Additional information has been requested.
Patient was given a Men Bexero vaccination instead of intented MenQuadfi Vaccine.
PMR Polymyalgia Rheumatica-severe pain in arm and shoulder, neck, hips trouble walking at first, also extreme fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: penacyllin" (unspecified if ongoing); "known allergies: sulfa" (unspecified if ongoing). Concomitant medication(s) included: DULOXETINE; HYDROCODONE; PRAVASTATIN; TRAZODONE. Patient was tested for COVID post vaccination (unknown results). Past drug history included: Immetrex, reaction(s): "Drug allergy". Vaccination history included: Covid-19 vaccine (dose 1, manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (dose 2, manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (dose 3 (booster), manufacturer unknown), for COVID-19 immunization. The following information was reported: POLYMYALGIA RHEUMATICA (disability, medically significant) with onset 04Oct2022, outcome "recovered with sequelae", described as "PMR Polymyalgia Rheumatica-severe pain in arm and shoulder, neck, hips trouble walking at first, also extreme fatigue". The events "pmr polymyalgia rheumatica-severe pain in arm and shoulder, neck, hips trouble walking at first, also extreme fatigue" required physician office visit. Therapeutic measures were taken as a result of polymyalgia rheumatica which included steroids.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Member noted usual redness around the site of vaccination 26JAN10. On the eve of 27JAN10, noted his arm was red, itchy, and swollen with numbness in left hand. Seen in urgent care center @ Hospital. He was given IV fluids and Levaquin 500mg per IV. He did have Labs drawn (CBC,blood cultures, CK) He was released and sent back to training with followup in clinic next day.
Mom stated child got very sick. Had fever of 100.3 with TYLENOL and MOTRIN. Had flu-like symptoms within 1 to 2 hrs of administration of vaccine-Saw MD next morning- did strep screen neg-.
Acute pericarditis. Symptoms (pain on left side of chest, going up to shoulder) began evening of 10/10, three days after Pfizer booster. Went to urgent care on 10/11. They suggested I go to an ER.
Myocarditis Managed with ibuprofen and monitoring Sx resolved in 1 day Trponins trended down in 3 days
patient received vaccination at 1:00 pm patient called into pharmacy stating he was starting to have hives with 4 present. No respiratory difficulty. Patient was advised to go directly to the Emergency Department. Phone call to Emergency Department to notify them of patient's need to be seen at their facility.
Covid Pneumonia; covid virus/tested positive for the covid virus; This is a spontaneous report from a non-contactable consumer. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration on 15Feb2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received, 1st dose Pfizer covid vaccine 15Feb2021, and in between 1st and 2nd dose, she got covid virus. The patient tested positive for the covid virus on 22Feb2021, went to ER on that Friday, found covid in her lungs, Diagnosed with Covid Pneumonia. The patient is scheduled on 08Mar2020, the patient wants some advice on pushing it back, and if and when she should get it. The outcome of the events was unknown.   No follow-up attempts are possible. No further information is expected.
Patient had vaccines 2/28/14 then 4 days later developed vomiting and diarrhea. Weight loss = 6 oz.
Fainted in 3 mts after the vaccine administration. Tech helped the patient to sit.Then he was fine talking. He did mention that he did not eat anything before coming for the vaccine.Called 911.All vital signs were tested and were good.
From an initial report received on 12/4/00, it was reported that a 38 year old male was given Menomune A/C/Y/W-135 on 11/29/00. On 11/30/00, it was reported that the pt experienced "generalized red rash. Pt was evaluated in an ER and treated with Zantac and Prednisone pack. Rash is resolving at this time. The pt had been on religious fast and rash occurred after eating". Follow-up information received on 3/27/01, reported on "12/4/00 (pt) called and said that he started to develop a raised, reddened rash on Friday night (12/1/00) after he ate. This is the month of Ramadan and he is fasting every day. The rash started in the axilla area and spread down his torso and into his legs. He also complained of abdominal pain that started at the same time. He went to the ER and received Zantac and a dose-pak of Prednisone. The medication is helping but every night the symptoms, although lessening, reoccur after he has broken his fast of the day and eaten. He is concerned that this may be related to the meningococcal vaccine. On 12/8/00, I called (the pt) and the symptoms have completely subsided." Additional pt, responsible physician and vaccine information was provided. The date of vaccination is listed as 11/28/00. Reportedly, the pt recovered from this experience.
Swelling and soreness in the arm of the injection site on 04/16/2021. On 05/22/2021 severe knee pain and joint pain in the left knee. I saw Dr. on 05/25/2021, he thought it was arthritis.  Pain medication- tramadol hcl 50 mg, every 6 hrs.  as needed, cream Diclofenac sodium topical Gel 1 %.  I had not had any pain prior to the vaccine. It could have been an underlying condition that was brought out by the vaccine. When the left knee first  flared up I could hardly walk, but it has gotten better.
The evening of 03/20/2021 the left side of my mouth began feeling numb and my left eye was drooping slightly.  The morning of 03/21/2021 I could not close my left eye or the left side of my mouth.  I went to the ER that morning and was diagnosed with Bells Palsy. I was given Prednisone and Acyclovir tablets.  As of today, 04/10/2021 I still have very slight paralysis on the left side of my face.
pt recv vax 15MAY98 & the next day pt exp muscle aches on rt side of the body;
Friday morning I woke up with a headache.  I then noticed my lymph node was swollen  on my left side of my lower neck.  My doctor prescribed me a Z pack.  Headache still went on till Sunday. Saturday I noticed the rash on my left arm where I had the vaccine.  Sunday it became bigger and started to tingly.  Monday morning rash is still there and now it's itchy.
She maybe had a sore arm for 2 days, 3 days max with the second one/ arm hurt a little more; With the second one maybe a little tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69 year-old female patient received bnt162b2 (BNT162B2), administration date 16Mar2021 (Batch/Lot number: unknown) as dose 2, single. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "She maybe had a sore arm for 2 days, 3 days max with the second one/ arm hurt a little more"; FATIGUE (non-serious), outcome "unknown", described as "With the second one maybe a little tired".  Additional information: The patient maybe had a sore arm for 2 days, 3 days max with the second one. With the first one there was nothing to report. With the second one maybe a little tired and arm hurt a little more. The patient had the last shot on 16Mar so it was waning.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected. Sender's Comments: Linked Report(s) : US-PFIZER INC-202101324789 Same patient and drug, different event separated in time
10-26-07 Client took flu shot, went home, later that afternoon broke out in hives on abdomen, arms, legs, hands, hands swollen, client took Benadryl per self - did not go to see doctor. 10-30-07 Called clinic to report reaction.
Ended up going to the hospital due to tachycardia; This case was reported by a consumer via call center representative and described the occurrence of tachycardia in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd February 2022, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 3 months after receiving Shingrix, the patient experienced tachycardia (serious criteria hospitalization). The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the tachycardia was recovered/resolved.   It was unknown if the reporter considered the tachycardia to be related to Shingrix.     Additional Information: GSK receipt date: 09-MAY-2022 Reporter's comment: The patient received the Shingrix vaccine in his left arm and ended up going to the hospital (no duration given for hospital stay) due to tachycardia.  The patient reported that the hospital had him take Benadryl and the tachycardia resolved after 2 weeks. The patient did add that he waited to report the adverse event until he received the hospital bill. The reporter did not consent to follow-up.
The vaccine expiration date was identified to expire on June 22, 2021, but the manufacturer expiration date was February 25, 2021.  Based on the information learned, Agency took the following steps: ? Contacted Moderna for guidance and based on Moderna data, the Moderna Medical Information team provided the following information:  o ?The vaccine administered on March 4, 2021 through March 10, 2021 from lot number 025J20-2A maintained the activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration.?  ? Contacted a county medical director and based on this information from Moderna, no re-vaccination is needed.
Initial report received from a consumer, who is also the patient, on 10 October 2014. A 60-year-old male patient, with a history of seizure "22 years ago", received an intramuscular left deltoid injection of FLUZONE (lot number not reported) on 07 October 2014. One day post-vaccination, on 08 October 2014, the patient began experiencing a headache, an aura with floaters in the left eye, a slight fever, and soreness at the injection site. According to the reporter, the soreness, headache and fever had subsided, and the aura in left eye was occurring less frequently. The floaters in left eye were ongoing and reported as "constant". The patient was scheduled to see an eye doctor on the day of the report (10 October 2014). Outcome remained ongoing. Documents held by sender: None.
Nausea; Lightheaded; Dizziness; Fever; This is a spontaneous report from a contactable consumer, the patient. A 23-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0179) via an unspecified route of administration in the right arm on 30Apr2021 at 15:15 (at the age of 23-years-old) as a single dose for COVID-19 immunisation. Medical history included syncope vasovagal. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the right arm on 09Apr2021 at 13:30 (at the age of 23-years-old) as a single dose for COVID-19 immunisation. The patient previously received metronidazole (FLAGYL) and experienced drug allergy. On 01May2021 at 00:00, the patient experienced nausea, lightheaded, dizziness and fever. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events nausea, lightheaded, dizziness and fever were resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
To unspecified patients of unknown age and gender. On an unknown date the unspecified patients might had vaccinated with improperly stored M-M-R II (lot#, dose, frequency and route unspecified), which were exposed to 53F for 12 hours and M-M-R II (lot#, dose, frequency and route unspecified), which were exposed to 54F for five hours. No adverse effects reported. Follow up information has been received from an office manager concerning a patient. On 15-NOV-2013 the patient was vaccinated with improperly stored M-M-R II (lot# J003791, exp. 28-MAR-2015), which were exposed to 54F for 5 hours (date excursion ended 06-SEP-2013). This is one of several reports received from the same source (linked MARRS#: 1311USA007619, 1311USA011609, 1311USA011610, 1311USA011611, 1311USA011612, 1311USA011613, 1311USA011614, 1311USA011616, 1311USA011615, 1311USA011617, 1311USA011619). Additional information has been requested.
emphysema severely; confused; This is a spontaneous report from a Pfizer-sponsored program by a contactable consumer reported for self. This 65-year-old patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose for COVID-19 immunisation and varenicline tartrate (CHANTIX). The patient stated, was old and confused. The patient had emphysema severely already and didn't want to die. The patient confused and was on 2 breathing medicines.  The patient didn't go anywhere due to health. The patient got the Pfizer COVID vaccine. Everyone has been saying it was killing them. It hasn't killed the patient yet. Action taken with varenicline tartrate was unknown. Outcome of the event was unknown.  lot/batch number has been requested.
Local reaction to varicella vaccine; right posterior arm had a silver dollar sized area of redness at injection site; no pain; afebrile;  was seen at PCP on 01/12/08 (3 days after vaccination)-- doctor suggested cool compresses and to watch for infection.
No adverse event. Bivalent vaccine given after Bivalent given from a different health department.
On 1/29/2021 at 10:10 am about 40 minute period of breathlessness/shortness of breath as if asthma attack were coming on. Have not had asthma in 15 years. Later, around 12 noon large red, hot, painful swollen rash came up around 3 inches injection site.  Called primary Dr, and allergist, who said to take antihistamine and pain reliever. Took Claritin and Tylenol. 1/30/2021 awoke and rash was more red,  painful, and swollen, and had spread to 6 inches in diameter. Returned to Vaccination Center, saw Dr on duty who looked at rash and recommended I call my primary for an antibiotic for a skin infection. My primary, prescribed Clindamycin began prescription on 1/31/2021. Night of 1/31/2021 awoke to pain on inner side of left arm, and intense itching in left underarm left chest, and left breast. Took Benadryl. I am still taking clindamycin for 10 days. Redness, swelling, pain reduce each day.
08-29-09 15:00 heartbeat irregular beats @ regular rate per patient.  Achy body.  Nausea.  09-30-09 17:00 Rash t/o body.  Itchy.  Patient will be treated with PREDNISONE & BENADRYL.
Patient called reporting hives, itching, swelling in her throat. Time of adverse event was at 1630. Follow-up with patient reporting that care was received at the local hospital and she wasn't not hospitalized but discharged that evening. Patient reported that she was given Claritin at the ER as treatment for her symptoms.