chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient said he had more than usual amount of redness and swelling at the injection site. also had enlarging breasts that took more than 4 weeks to subside . Adverse reaction did subside on it own
mom noted swelling & redness @ inject site w/in 45mins p/pt recvd vax; was seen by MD in PM of same day; reported significant swelling & erythema near inject site w/fever >100;
developing a dry cough as soon as he got the 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (developing a dry cough as soon as he got the 1st dose) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced COUGH (developing a dry cough as soon as he got the 1st dose). At the time of the report, COUGH (developing a dry cough as soon as he got the 1st dose) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Other relevant medication history included blood pressure med.  Treatment information was provided cough drops.   This case was linked to MOD-2021-211391 (Patient Link).
This case was received from a pharmacist on 23 July 2009. It involves a cluster of three unidentified patients. Three patients received intramuscular injections of Tripedia (lot number U2471BA). Following vaccination, all three were seen in the emergency department with symptoms of Cellulitis, inflammation, and soreness at the injection site. No additional information was provided, and outcome was unknown. Follow-up information received 31 July 2009 from a health care professional. According to the reporter, there were total of six adults who experienced the events (previously reported as three). Per the reporter, the patients had been large adults who had received Tripedia instead of Adacel. The needle length used to administer the vaccine had been 5/8 in length; and they developed cellulitis. Recovery status was unknown at the time of the report.
Arm became blotchy; Red; Hives which has gone to her face, chest and neck; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (Arm became blotchy), ERYTHEMA (Red) and URTICARIA (Hives which has gone to her face, chest and neck) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced RASH MACULAR (Arm became blotchy), ERYTHEMA (Red) and URTICARIA (Hives which has gone to her face, chest and neck). At the time of the report, RASH MACULAR (Arm became blotchy), ERYTHEMA (Red) and URTICARIA (Hives which has gone to her face, chest and neck) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication not reported.  Treatment medication not reported.
This spontaneous report was received from a registered nurse refers to unspecified number of patients of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On an unknown date, the patients were vaccinated with unspecified improperly stored doses of VARIVAX (Merck) (route of administration, anatomical location, expiration date and lot number were not provided). There were not concomitant medications provided. No adverse effects were reported. There was no product quality issue involved. Additional information has been requested.
DTaP given 6/24/09. 6/26/09 woke with painful, red and swollen arm.
Left deltoid has been twitching. Not constant but frequently and sometimes can feel it all up and down the arm making it difficult to use.
Severe headache; Nausea; Vomit; This is a spontaneous report from a non-contactable consumer, the patient. A 29-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the right arm on 30Mar2021 at 18:00 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to shrimp. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient did not receive any concomitant medications. On 21Apr2021 at 09:00, the patient experienced severe headache, nausea and vomit. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events and included treatment with omeprazole (MANUFACTURER UNKNOWN) and ibuprofen (MANUFATURER UNKNOWN). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events severe headache, nausea and vomit was recovering at the time of this report.  No follow-up attempts are possible. No further information is expected.
Awoke at 4am with extreme soreness, heat in left arm   Also began feeling flu-like symptoms.  Woke up in the morning with mild fever, fatigue, aches, pain in blowback & right kidney area, left arm very sore.  Began sweating that evening & the fever broke.  Fatigue continues, as does pain in low back/right kidney area.  Had about a week of excessive & frequent  urination that was hard to control.  I can control urination now & the amount & frequency is back to normal.  Pain in low back/right kidney area continues - not certain if it's muscular or kidney.
vaginal bleeding/wasn't like a heavy period but like something during the last day of period would look like, it was light; when wiped, something pink is still there but not red/it was more like a little discharge; This spontaneous case was reported by a consumer and describes the occurrence of VAGINAL HAEMORRHAGE (vaginal bleeding/wasn't like a heavy period but like something during the last day of period would look like, it was light) and VAGINAL DISCHARGE (when wiped, something pink is still there but not red/it was more like a little discharge) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     Concomitant products included LEVONORGESTREL (MIRENA) for Birth control, LOSARTAN, AMLODIPINE BESYLATE and VENLAFAXINE for an unknown indication.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced VAGINAL HAEMORRHAGE (vaginal bleeding/wasn't like a heavy period but like something during the last day of period would look like, it was light) and VAGINAL DISCHARGE (when wiped, something pink is still there but not red/it was more like a little discharge). At the time of the report, VAGINAL HAEMORRHAGE (vaginal bleeding/wasn't like a heavy period but like something during the last day of period would look like, it was light) and VAGINAL DISCHARGE (when wiped, something pink is still there but not red/it was more like a little discharge) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Mirena birth control for an unknown indication.  No treatment medication was reported.
Crushing headache like head was in a vice. Fever, which broke at 3:00 am. (19.5 hrs after shot) Itchy & tingles at base of neck for a very short time-maybe 5 min. Headache & fever started at 7:00 pm (11.5 hrs after shot), headache lessened in intensity abut 11:30 am (28.5 hrs after shot. Headache gone about 48 hrs after shot.
1 day after shot pt developed grogginess, chills in the evening, and the next morning, 2 days later scarlet red rash appeared on bilateral legs, left worse than right, ongoing, evaluated for possible cellulitis, versus vasculitis (elevated CRP), and venous stasis dermatitis, versus drug eruption (as he was placed on augmentin). seen at acute care, local dermatology and ER within 6 days. Rash abating and now followed by extensive lower extremity swelling.
Red, non tender mildly warm areas on bilateral deltoid (R) 8x7 cm (L) 10x9 cm.
This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. The patient's concurrent conditions, pertinent medical history and concomitant medications were not reported. On unspecified dates, unspecified patients were administered with an improperly stored GARDASIL 9 (dose and route of administration were not provided: lot # L013429 and expiration date on 21-JUL-2017). No adverse effects were reported. No product quality compliant (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Chills-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Headache-Mild, Systemic: Shakiness-Mild
The patient experienced syncope, diaphoresis, nausea and vomiting.  The patient was able to recover within 45 minutes and leave under his own power.  The patient was coherent and not in any noted distress.
After I came home that night I had sharp chest pains on the left side of my chest (near the left side of my heart).   I also work
Patient tested positive for COVID-19 11/11/21. Patient received 2nd Johnson & Johnson COVID-19 vaccine 11/6/21.
reported welt size of palm @ inj site lt arm;feverish & red @ site & itches;noted on morning 10OCT96;self treated by cleaning & applied lotion;
Covid positive 1.11.21. Sunday after Vaccine began with headache, body aches and chills. Cough started on  Monday and full nasal congestion by Friday, 11.8.21.  Covid tested Monday, 1.11.21 due to post covid vaccine questionnaire followup through workplace recommendations for covid testing. Got covid positive results about 7pm 1.11.21
Breakthrough case admission after 3 vaccines Moderna 1/6/21 Lot# 012L20A;  Moderna 3/3/21 Lot# 012L20A;  Moderna 12/22/21 Lot# 060H21A
The morning following the vax, the pt experienced a fever. The fever lasted 3 days. The pt then developed a non-pruritic rash as fever broke 5 days post vax.
I received a shot on 7 April. A couple of days later, I received a phone call from a health facility stating, vials of the vaccine were stored outside of the temperature range recommended by Moderna, which affects the viability. The person on the phone recommended I get another 1st dose. On April 21 (2 weeks later) I received a second 1st dose, and I experienced strong side effects. Yesterday morning I had a 103-degree temperature, chills, dizziness and weakness, along with tremendous muscle pain in the injection area. Also, the injection area has a bright red circle and is hot to the touch. I said to the vaccine administrator that the injection did not feel similar to the first one because it hurt going in. She responded with that the worst part, and now it's over.
This spontaneous report was received from a physician via a company representative and refers to 44 female patients of unknown age. There was no information regarding the patients' pertinent medical history, drug reactions, allergies or concomitant therapies provided. The physician found out about the event reported below from an online article. On unknown dates, the patients were vaccinated with doses of GARDASIL (lot #, expiration date, exact dose, site and route of administration were not reported). On unknown dates, the patients died as a result of receiving GARDASIL (also reported as they died from these vaccines). The relatedness between the event and GARDASIL was assessed as related. Upon internal review, the event of death was determined to be medically significant. This is one of two reports received from the same source. Additional information is not expected as there was no consent for follow-up.
the arm just being a little sore for 24 hours; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old male patient received BNT162b2 (BNT162B2), on 08Feb2021 as dose 1, single (Lot number: EL9264) at the age of 71 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "the arm just being a little sore for 24 hours". Relevant laboratory tests and procedures are available in the appropriate section. Additional information included He has tested positive for covid and went in and got his test; he just scooted up in his seat and ran into it and hit his head and glasses and is bald headed and has taken more skin off of the top of his head because he does not wear a hat and is bald so does not feel anything and that got his skin. They were all in the left arm and the time of administration varied from 10:00am to 2:30-3:00pm and his were at the same facilities as his wife's vaccines. Card does not have handwritten the expiry dates or NDC numbers for his vaccine doses. They had no adverse effects other than the arm just being a little sore for 24 hours and they did not get sick themselves after the pfizer covid vaccines; the sore arm was pretty much with all of the Pfizer covid vaccines where the arm was a little sore but it was nothing like being killer sore and it was not as bad as the tetanus shot which hurts usually pretty good after you get it and not at the time you get it because they use a small needle but then it gets pretty sore; has no manufacturer, lot, expiry date or NDC for his tetanus shots as his last one was 10 years ago and he does not have that information. Prior Vaccinations (within 4 weeks):Vaccines 4 weeks prior: got the flu shot he thinks somewhere around the time he got the Pfizer Covid vaccine 3rd dose and the flu shot may have been within a week of the covid vaccine 3rd dose so the flu shot may have been on 21Sep2021; has no manufacturer, lot, expiry date or NDC for the flu shot to provide.      ; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201399436 same reporter/ patient, same drug, different AE.;US-PFIZER INC-202201399615 same reporter/patient, same drug/different dose, same AE (dose 2);US-PFIZER INC-202201399616 same reporter/patient, same drug/different dose, same AE (dose 3);US-PFIZER INC-202201399617 same reporter/patient, same drug/different dose, same AE (dose 4);US-PFIZER INC-202201399618 same reporter/patient, same drug/different dose, same AE (dose 5);
Mild Tongue tingling, No Respiratory issues; stable Vital Signs Improved after Benadryl 50 mg (by mouth) administration
Initial report received via search of the literature on 16 April 2013. This case contains information for 1 of 22 patients whose clinical data were provided. Information regarding the other 21 patients is captured in case numbers 1995-00224, 2003-02926, 2006-03086, 2006-03230, 2011-03827, 2013-02288, 2013-05188, 2013-05251-05261, 2013-05263 and 2013-05268-05269. From the published article, the authors reviewed charts of patients who had been hospitalized with Guillain-Barre Syndrome (GBS) from 1995 through 2006. Using a case-centered design, they compared the odds of vaccination in the 6 and 10 weeks prior to onset of GBS to the odds of vaccination during the same time intervals in all vaccinated individuals in the entire hospital population. While cases of GBS had been reported following a wide range of vaccines, a clear association had only been established with the 1976 H1N1 inactivated influenza vaccine. The authors confirmed 415 cases of which only 25 had received any vaccine in the six weeks prior to GBS onset. Vaccines received included TIV, 23-valent polysaccharide pneumococcal vaccine, tetanus-diphtheria combination vaccines, Hepatitis A and Hepatitis B. The large retrospective study did not find any association between influenza vaccine or any other vaccine and the development of GBS within 6 weeks following vaccination. According to the authors, the risk of GBS following any vaccine, including influenza vaccines, was extremely low. This case involved a 57-year-old male patient who had received Trivalent inactivated influenza vaccine (manufacturer, lot number, route, site and date of administration not reported) and 21 days later reported the onset of GBS. No further information was provided. Outcome was not reported. Documents held by sender: none.
Severe body aches, extreme chills, high fever of 103. I know the side effects are possible, but the high fever was worrisome. It took 2 doses of Tylenol 4 hours apart before it dropped any. The entire next day I also had to continue the Tylenol or my fever would spike again.
Patient received a 6 month to 4 year Pfizer Bivalent booster on 7/27/23. Patient tolerated vaccine well and waited 15 minutes post vaccine with no adverse reactions noted.  Patient received 6 month to 5 year Moderna for the primary series on 11/8/22 and 1/26/23. Attempted to notify mother of child of adverse event on 7/27/23.
Their arm was sore at the injection site.; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Their arm was sore at the injection site.) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, the patient experienced PAIN IN EXTREMITY (Their arm was sore at the injection site.). At the time of the report, PAIN IN EXTREMITY (Their arm was sore at the injection site.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. No treatment was reported.    This case was linked to INC.-MOD-2021-138343, INC.-MOD-2021-138859 (E2B Linked Report).; Sender's Comments: INC.-MOD-2021-138343:Case cross linked dose 1 for the 3 family members, INC.-MOD-2021-138859:Case cross linked dose 1 for the 3 family members.
Approximately 5.5 hrs after vaccination - High fever with severe full body shakes lasting about 3 hours followed by a slight fever of 99.7 for about 16 hours, severe headache lasting about 24 hours, Full body aches lasting about 16 hours, tiredness lasting about 36 hours, moderate headache lasting about 3 days.
After the vaccine within a few hours I felt tired, achey and the chills plus a sore arm that hurt for 3 days. Nearly 7 days after the vaccine I have a lump in my armpit on the same side as the vaccine that hurts to the touch.
Information has been received from a pharmacist referring to 2 newborns (numbered 221 and 222). Background: Since June 2015, there had been 1645 times (30 minutes each time = 822.5 hours) that the temperature dropped below 36F. Of course, there was 144 times (30 minutes each time =72 hours) that temperature was 32F, the lowest being 29.7F. On 04-JUL-2015, there was a low temperature of 30.2F. On 24-SEP-2015 the patients were vaccinated with the improperly stored RECOMBIVAX HB strength 2.5/0.5 (units not provided) (lot number K020216 and expiration date of 17-SEP-2016) (dose and route of administration were not reported). There was no product quality complaint (PQC). This is one of several reports received from the same reporter. Additional information has been requested.
High frequency ringing on the ears that sounds like lots of different high pitch frequencies. Keeps getting worse and it hasn?t stopped since 1st vaccine. I?ve had ringing before but never like this. As soon as sit still it?s so noticeable and annoying.
fever 104-105; vomiting x 5 during noc 21APR95; jerking involuntary; better by morning;
A bright red rash measuring approximately 4x3inches  developed at injection sight 8 days after vaccine. The rash was hot to the touch and tender.
?COVID Arm? - On 26Apr2021 I noticed a red circle around the injection site, approximately 2.5 inches in diameter. It was red at the edges and slightly yellow at the center. It was slightly tender to touch. It progressed to a circle approximately 4 inches in diameter over the next few days, the entirely of it turning pink. It became raised on the second day; it was evenly raised across the surface of the circle?s entire diameter. It remained sensitive to touch. It then became slightly itchy. Exercise made the swelling go down temporarily. It was gone by 30Apr2021.
The exact time of the shot is a guesstimate. She has had local reactions to each of the flu shots since the first flu shot she was given. Trying to eliminate what it could be, we requested a preservative free vaccine for her second H1N1 dose. She complained immediately after the shot was given that it was burning. Thirty minutes after the shot her deltoid muscle swelled where she had received her vaccine.  She complained of not feeling well but was unable to be more specific. An hour and a half after receiving the vaccine she had a rash that extended above the site as well as down to the wrist. she became pale and would only communicate via head nods.I gave her 2 childrens benadryl and watched her. Forty five minutes after being given the Benadryl she began to perk up and the rash didn't spread any further at that time. She was given 1 Benadryl about an hour prior to the shot to keep her from reacting. The next morning she had a 2.5" X1.5" red wheal in the area of her shot. The rash was still present but was only localized to the arm that was vaccinated. She also had a severe eczema flare 24 hours later following her shot that was all over her body. By Friday of the same week her eczema flare had calmed down and her wheal was only faintly visible.
Frozen left ankle - unable to walk for 5 minutes.   Surgically repaired left ankle trimallear fracture in 2009
The patient received IPV, DTaP, and Comvax at 3:30, he then started vomiting at 3:30. The patient vomited 5 times until 7:45 and then it stopped. The mother began to feed the infant at 7:45, he fed successfully 4-5 times during the night. The patient has had no other apparent side effects.  The mother was advised if the patient continues to vomit, has a fever greater than 102., seizes, or becomes non-responsive go to the ER.
(L) back pain below shoulder blade with bilateral upper thigh pain now resolved on 11/20/2010 (R) shoulder muscle pain and (L) axillary pain.
Painful arm, Itching, swollen , Warm to touch rash, Large rash/lump/urticaria
heart rate was elevated to 140-160; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 23 year-old male patient received bnt162b2 (COMIRNATY), administration date 2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose:1), for COVID-19 immunization. The following information was reported: HEART RATE INCREASED (non-serious) with onset 2021, outcome "unknown", described as "heart rate was elevated to 140-160". Relevant laboratory tests and procedures are available in the appropriate section.  the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
I received my vaccination on a Thursday night. I had mild syptoms over the weekend with a sore arm (no rash).  I woke up Tuesday morning with a large, warm rash on my right bicep.  It is about 6" long  x 5" at the widest. I have it circled to see if it goes down.  It is 5:30pm on Tuesday and it has not shrunk.  I have taken ibuprofen, antihistamine, & used cortisone cream.  It is less red, but still warm to the touch.