chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Itching at injection site; Injection site redness; Swelling at injection site; Rash at injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PRURITUS (Itching at injection site), INJECTION SITE ERYTHEMA (Injection site redness), INJECTION SITE SWELLING (Swelling at injection site) and INJECTION SITE RASH (Rash at injection site) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE PRURITUS (Itching at injection site), INJECTION SITE ERYTHEMA (Injection site redness), INJECTION SITE SWELLING (Swelling at injection site) and INJECTION SITE RASH (Rash at injection site). At the time of the report, INJECTION SITE PRURITUS (Itching at injection site), INJECTION SITE ERYTHEMA (Injection site redness), INJECTION SITE SWELLING (Swelling at injection site) and INJECTION SITE RASH (Rash at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication information was not provided by the reporter.  The treatment information was not provided by the reporter.  Upon internal review on 04-AUG-2021, the age was corrected to 73 years.
Dose 1 (2/27/2021): Injection site soreness/stiffness and leg muscle aches (difficulty walking).  Night sweats Dose 2 (3/27/2021): Fever, chills, body aches/weakness, night sweats lasting longer than 24 hours. Dose 3 (11/5/2021): Swelling, redness, itching, and heat at the injection site.  Seems to have settled into the left collar bone and next with swelling, tenderness, and heat.  Hurt all over my body for 24 hrs.  Now just sitting in the collar bone, shoulder, and neck.
Information has been received from a medical assistant referring to a patient of unknown age and gender. On 10-MAR-2016 the patient was vaccinated with an expired dose of RECOMBIVAX HB (lot # K019502, expiration date 04-FEB-2016) intramuscularly (dose was not reported). No adverse effect was reported. Additional information has been requested.
Immediately after vaccine was administered patient's body became limp, eyes closed and patient began to snore, with skin color becoming pale. Mother was able to awaken patient after approximately 3 seconds. Writer had a tech sit with patient while getting provider that had seen patient in clinic.  Provider assessed patient in immunization room.  Patient was able to verbalize communication and after sitting in room for over ten minutes was able to stand and walk on his own out of clinic with mother.
Within two to three minutes after receiving the varicella vaccine, she started vomiting. Her arm (where the vaccine was given) became red, hot and swollen within minutes of receiving the vaccine. About 20 minutes later, she became very pale/grey in color. She continued vomiting throughout the day and developed diarrhea and shortness of breath a few hours after the vaccine was administered. The diarrhea continued for six days. She was previously healthy with no sign of illness before receiving the vaccine. She was treated with Benadryl, Phenergan and Albuterol for five days and was followed up by phone with her PCP.
Patient reported to the clinic stating he thinks he has had a reaction to the PNEUMOVAX given yesterday. Left upper arm appears reddened and swollen. Patient states he was awake all night with chills and fever. Temp. today in clinic was 97.1. Doctor here to observe and inspect. Area marked with surgical skin-marking pen. With recheck 6/18 symptoms resolved without antibiotic therapy. Symptoms: Angioedema Treatment Drugs Used: Diphenhydramine Dose: 50 units:MG Freq: PRN Route: PO
This is a 74-year-old female with a history of hypertension who presents to the emergency room complaining of chest pain and hypertension.  She states the chest pain is midsternal and burning in nature.  There are no relieving or instigating factors.  At its worst the discomfort is 3/10 in intensity.  She states it started after noting that her blood pressure was 190/100 prior to arrival.  She denies associated nausea, vomiting, shortness of breath or diaphoresis.  Of note patient is COVID positive but denies any shortness of breath, cough, fever or chills.  She did cieve both Pfizer vaccinations.   In the emergency room her troponin was 144.  Her blood pressure is now  8/5/2021tested positive 8/7/2021 discharged This is a 74-year-old female with a history of hypertension who presents to the emergency room complaining of chest pain and hypertension.  She states the chest pain is midsternal and burning in nature.  There are no relieving or instigating factors.  At its worst the discomfort is 3/10 in intensity.  She states it started after noting that her blood pressure was 190/100 prior to arrival.  She denies associated nausea, vomiting, shortness of breath or diaphoresis.  Of note patient is COVID positive but denies any shortness of breath, cough, fever or chills.  She did cieve both Pfizer vaccinations.   In the emergency room her troponin was 144.  Her blood pressure is now 143/67. Her oxygenation is 100% on room air.  CBC is unremarkable.  Sodium is 130 and glucose is 143.   Patient denies any fever, cough, chills, rhinorrhea, sore throat, shortness of breath, palpitations, orthopnea, paroxysmal nocturnal dyspnea, nausea, vomiting, diarrhea, constipation, hematuria, dysuria, frequency, melena, hematochezia or focal neurological complaints
Fever lasting until the next day, fussiness (wanting held constantly and crying). Small bumps on forehead, under eyes and across nose the next evening.
Following the mRNA COVID-19 Moderna booster on 11/18/21, and afterwards had fever that resolved and some mild L arm soreness in area of injection site. The L arm soreness was persistent. However 1 week following the booster (starting 11/24/2021), had worsened L arm pain with swelling down to his hands and tightness and fevers that did not improve with Tylenol. He reports that he did not have significant rash overlying the arm. He was evaluated with US that was negative for DVT. He was discharged with tylenol and ibuprofen without relief. He again presented to the ED after a few days on 12/2 with CT LUE that showed superficial soft tissue edema without collections and was prescribed cephalexin without benefit and symptoms progressed. Fevers at home have been in the 100s deg F.   When he presented at facility, he had CT LUE with "phlegmatic changes of the left deltoid muscle with surrounding cellulitis and diffuse low-level soft tissue swelling extending across the left upper extremity. Febrile to 101.7 on admisison. No well defined peripherally enhancing fluid collection as to suggest abscess"  ESR 127, CRP 187.9. CK 140-160. and MRI LUE with "extensive myositis involving the left deltoid, triceps and to a lesser extent brachioradialis musculature with surrounding cellulitic changes of the visualized proximal upper extremity". TTE was WNL.  He was initially treated with cefazolin->CTX, clinda ->vanc/zosyn, without significant improvement in symptoms. He has a muscle biopsy . Muscle biopsy showed no infection. Antibiotics were stopped. He was started on prednisone for concern for vaccine related myositis, pain then quickly improved.
pt recv vax 15JUL95 & 16JUL96 devel pruritic rash around the inj site which resolved in a couple of days;19JUL96 pt devel a small patch of mosquito like vesicles on the legs & arm which quickly resolved;
Fever, chill, extreme fatigue even with plenty of rest (18-20h), muscle ache, neck and shoulder pain greater than usual,
pt recv vax & felt dizzy, slept all day & devel a rash which spread from the inj site;
Injection site was warm to the touch; Itchiness at the injection site; Developed a 2.5 inches in diameter of redness around the injection site; Pain in lymph nodes under the same arm received injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Injection site was warm to the touch), VACCINATION SITE PRURITUS (Itchiness at the injection site), VACCINATION SITE ERYTHEMA (Developed a 2.5 inches in diameter of redness around the injection site) and LYMPH NODE PAIN (Pain in lymph nodes under the same arm received injection) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 013L20A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma and Allergy to antibiotic (allergy to cefine). Concomitant products included LEVOTHYROXINE, ESTROGENS CONJUGATED (PREMARIN), FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR), VALSARTAN (DIOVAN) and DILTIAZEM for an unknown indication.   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Injection site was warm to the touch), VACCINATION SITE PRURITUS (Itchiness at the injection site), VACCINATION SITE ERYTHEMA (Developed a 2.5 inches in diameter of redness around the injection site) and LYMPH NODE PAIN (Pain in lymph nodes under the same arm received injection). At the time of the report, VACCINATION SITE WARMTH (Injection site was warm to the touch), VACCINATION SITE PRURITUS (Itchiness at the injection site), VACCINATION SITE ERYTHEMA (Developed a 2.5 inches in diameter of redness around the injection site) and LYMPH NODE PAIN (Pain in lymph nodes under the same arm received injection) outcome was unknown.            Patient was allergic to Iodine dye. Treatment medication included Advil and a antihistamine/cold tablet and kept ice on the injection site.   Most recent FOLLOW-UP information incorporated above includes: On 19-Jun-2021: F/U-1 : VAERS received on 19-JUN-2021 : Medical history and allergy was updated. Patient details :  Height, Weight, Race, Ethnic group was updated. Dose 2 information was updated. Route of administration , anatomical site, batch no. was updated. Action taken , De-challenge and Re-challenge were 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.
No physical symptoms; after vaccination this RN identified that the patient received the booster dose too early from completion of the primary series. #1 5/4/21. #2 6/1/21 and booster on 10/27/21
lightheadedness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 72-year-old female patient received BNT162b2 (BNT162B2), on 25Feb2021 as dose 1, single (Lot number: EN6918) at the age of 71 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "blood pressure" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID; VERAPAMIL taken for blood pressure abnormal; LORAZEPAM; AMBIEN. The following information was reported: DIZZINESS (non-serious), outcome "not recovered", described as "lightheadedness". The event "lightheadedness" required physician office visit and emergency room visit.  Additional information: The patient received the Pfizer-BioNTech COVID-19 vaccine two initial shots and two booster doses and was scheduled for the next Pfizer-BioNTech COVID-19 vaccine shot the day after and she remembered that after she had received the first Pfizer-BioNTech COVID-19 vaccine she started experiencing lightheadedness, about a year and a half ago. It's chronic and don't know whether this could had been caused by the Pfizer-BioNTech COVID-19 vaccine. Her lightheadedness was not going away and requested information on whether lightheadedness had been reported as a side effect for the Pfizer-BioNTech COVID-19 vaccine. Additionally stated she would get her scheduled booster dose regardless of the lightheadedness she was experiencing. The lightheadedness was ongoing and chronically the same as when it began. She does not know what it was and was not dizzy and does not have vertigo but was very lightheaded or something. Takes medications and takes Synthroid, Rapamil (as reported) for blood pressure and occasionally takes Lorazepam but not too often and takes Ambien one and one forth and had been taking all these medications for years. Caller stated her son: "Had a severe reaction for a flu shot almost three years ago, he was so severely ill he had a temperature of 104 degrees, almost comatose" and that "he got COVID in Dec". Caller stated she did not know the name of the flu shot he received. Caller stated her son was 41-year-old. The patient had no other conditions and investigations. Prior vaccinations (within 4 weeks) were none. Patient's medical history and family medical history relevant to ae(s) were none. It was also reported that patient had 2nd dose on 18Mar2021 with lot EN6207; 1st booster on 30Sep2021 with lot 20158BA; 2nd booster on 04Apr2022 with lot FK9895.
Fainting; This case was reported by a physician via sales rep and described the occurrence of fainting in a 18-year-old male patient who received Men B NVS (Bexsero) for prophylaxis.   In July 2019, the patient received the 1st dose of Bexsero (intramuscular) .5 ml. In July 2019, less than an hour after receiving Bexsero, the patient experienced fainting (serious criteria GSK medically significant). On an unknown date, the outcome of the fainting was unknown.   It was unknown if the reporter considered the fainting to be related to Bexsero.  Additional details were provided as follows: The patient fainted after vaccination of Bexsero. The patient received vaccine on an unknown arm sometime last week before the date of reporting. This case has been linked to the case US2019133857, reported by the same reporter.
extreme chills; neck is aching; right arm pain; the pain prevented her from sleeping; Itching; This is a spontaneous report from a contactable consumer report self. This 72-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular at right arm on 12Jan2021 15:30 at single dose for covid-19 immunisation. Medical history included had COVID back in Nov2020, blood cholesterol abnormal. Concomitant medication included Pravastatin for blood cholesterol and unspecified water pill. No prior vaccinations within 4 weeks. No additional vaccines administered on same date. Patient received Pfizer covid vaccine on 12Jan2021 around 15:30. Her right arms started getting in pain about 11pm and the pain prevented her from sleeping most of the night till she took an Aleve around 6am. She took another Aleve on 13Jan2021. She can barely raise her right arm and it is ok if she does not try to use it but if she tried to use her right arm then it is inoperable. At 12Jan2021 night after she got the vaccine she experienced itching, she never got a rash, the itching never got bad and it went away. She has not taken her temperature. She was having extreme chills that started around 13Jan2021 3:00 pm and she cannot get warm, she has blankets piled on her. Her neck is aching (started 13Jan2021 afternoon) and she thought this may be from tensing up since she is cold. No emergency room or physician office visit. The outcome of "Itching" was recovered, of else events was unknown.  Information on the lot/batch number has been requested.
On 9/28/09, received vaccine @ 10:30 AM.  9/28/09 @ 3 PM noted bottom lip swelling.  9/28/09 @ 4:30 PM increased swelling of lips.  Called ER.  Treated with BENADRYL - Did not go to ER.
This prospective pregnancy case was reported by a nurse via call center representative and described the occurrence of vaccine exposure during pregnancy in a 22-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2021-2022 season) (batch number 977EN, expiry date 30th June 2022) for prophylaxis. Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis and INFLUENZA VIRUS VACCINE INACTIVATED (FLUZONE (SEASONAL INFLUENZA VACCINE)) for prophylaxis. On 12th December 2021, the patient received the 2nd dose of Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device. On 2nd November 2021, the patient received FLUZONE (SEASONAL INFLUENZA VACCINE). The patient's last menstrual period was on an unknown date and estimated date of delivery was on an unknown date. The patient received Fluarix Quadrivalent 2021-2022 season at an unknown time during the pregnancy. On 12th December 2021, unknown after receiving Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced extra dose administered. On an unknown date, the patient experienced vaccine exposure during pregnancy. On an unknown date, the outcome of the vaccine exposure during pregnancy and extra dose administered were unknown. The pregnancy was ongoing.  This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional details were reported as follows: Nurse called to report that a medical assistant administered a pregnant patient the FLUARIX vaccine (on the day of reporting) and after administration found out that the patient had received FLUZONE vaccine, which led to extra dose administered. 28 weeks and 1 day pregnant at exposure to Fluarix vaccine. Nurse would like to know if there were any adverse events that had been reported after administering 2 flu vaccines. Call abandoned whilst warm transferring call to Medical Information. The reporter consented to follow up.
Patient inadvertently received Dtap and Hep A immunizations.  The patient was only due to receive a single dose of Hep B vaccine, which was later administered to comply with school entrance requirements.    There were no adverse reactions, no treatment required and no negative outcomes.
heart rate (HR) was 180; tongue and lips tingled; walking for a short distance and felt "off; This is a spontaneous report from a contactable Nurse reported for herself. This 34-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EK9231), via an unspecified route of administration on 29Dec2020 15:15 at single dose on left arm for Covid-19 immunisation. Medical history included allergies to hepatitis B vaccine rhbsag (HEY B VACCINE) booster and poison ivy. Concomitant medication included biotin / calcium pantothenate / cyanocobalamin / folic acid / nicotinamide / pyridoxine hydrochloride / riboflavin / thiamine mononitrate (B COMPLEX), fexofenadine, ascorbic acid (VIT C) and Multivitamin. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Immediately after shot (29Dec2020 15:15), her tongue and lips tingled but it went away quickly. She was walking for a short distance and felt "off." The patient checked her pulse and pulse ox and her heart rate (HR) was 180. Her HR had bounced around from 150-180 with minimal exertion and was in the 90s at rest. No treatment received for the events. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The outcome of not recovered. The events were non-serious.; Sender's Comments: A causal association between BNT162B2 and the event heart rate increased cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Full blown varicella with >100 pox marks, 19 days, post vax. Had a low-grade temperature. Rx'd with Zovirax 300mg po every 6 hours X 5 days.
On May 7, 2 Days after receiving the Moderna shot, I started to get breast tenderness, indicating an upcoming menstruel cycle, despite not being due until May 17. It is important for me to note here that my period is always on time (within a day or 2). On May 9, I began to have some cramping. When I got out of the shower on the morning of May 10, I had begun bleeding. At this point, the cramps began to worsen. Often leaving me doubled over in pain (while common for some women, this is completely abnormal for me. I normally don't have any cramping at all.) The bleeding itself is heavier than usual. I'm also extremely exhausted compared to usual.
2.5 cm x 2.5 cm slightly erythemic, mildly warm area around injection site, non-tender, left thigh. The follow up received on 9/9/03 states DTaP/Hib problem area. No Rx observe only.
I was immediately nauseous and a moderate headache started about 15 mins after the shot.  The next day I had moderate body aches, nausea, and mild light headedness.  I've had those ongoing symptoms (minus the body aches) up to the present day.  They've never really gone away, and continue to persist.  I did not have any of these symptoms prior to the shot.  I called my doctors office today to report the symptoms, and I'm still waiting to hear back.
pt recv vax & devel a sl red, raised, non tender lesion (2cm) @ inj site;
Sore left arm at injection site for about a day. On Jun 8th, I, his fiancee who lives with patient, started to develop a cough that worsened throughout the week. At first I thought it could be allergies since it was accompanied by congestion, but OTC allergy medication did not help. He also had some alergy symptoms but they cleared with OTC allergy medication. Because my coughing was so bad, we decided to sleep apart so he could sleep. When sleeping apart my cough got better. When sleeping together my cough got worse again. I noticed the correlation and we are choosing to sleep apart for a period of time and check to see if the correlation is still there. As of the date of this entry when I am in close contact with him for over 20 min my cough gets worse, and clears when we are apart.  Note: we are both teachers and neither of us has had any respiratory issuse throughout the school year even when stidents were back in building. I have not recieved the Vaccine. There has been no changes to detergent, soap, or cleaning supplies.
First 4 hours post injection no serious side effects, slight headache was settling in.  At approx. 8PM (7 hours after shot) I had fairly a severe reaction of horror for the next 16 hours - all night long.  Heart racing/energy beyond, deep chills and severe whole body shaking to the point of my back going out (dont' have a bad back), fever, migraine headache so bad (i dont get headaches) and body aches from a horror movie.   I'm a jock, run daily, healthy, no smoke, drink or drugs. This lasted all night long well into the morning. At 3Am i considered going to the ER, but didnt. By 2pm the following day most of it went away. Two days later (today) i am dizzy, heart feels fast or racing, naseuous earlier , and exhausted. I can deal with it now, but it's very uncomfortable. Frankly, I regret getting the vaccine, wish i had not.   I had covid last March, it was no big deal beyond what a flu would have done...with some shortness of breath on and off for a few months. The reaction to the vaccine is viccious compared to covid itself (for me, just my experience). Hope this all stops and goes away.   Thank you for your work!
I had a COVID vaccine on Dec 28th. My arm hurt a little but nothing bad. I felt like shot was given sub q at the time but didn?t worry about it. It was little red, but as the week has gone by it have gotten red, larger, firm. I have included picture.