chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Injection site hot; Arms and head was itchy; Faint pink mark where it was red; Very itchy; Became bumpy; Red rash on the injection site; Red rash on the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (Injection site hot), PRURITUS (Arms and head was itchy), APPLICATION SITE DISCOLOURATION (Faint pink mark where it was red), INJECTION SITE PRURITUS (Very itchy) and INJECTION SITE URTICARIA (Became bumpy) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Atrial fibrillation (Patient has Afib, and is on blood thinners.). Concomitant products included APIXABAN (ELIQUIS) for an unknown indication.    On 27-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE WARMTH (Injection site hot), PRURITUS (Arms and head was itchy), APPLICATION SITE DISCOLOURATION (Faint pink mark where it was red), INJECTION SITE PRURITUS (Very itchy), INJECTION SITE URTICARIA (Became bumpy), INJECTION SITE RASH (Red rash on the injection site) and INJECTION SITE ERYTHEMA (Red rash on the injection site). At the time of the report, INJECTION SITE WARMTH (Injection site hot), PRURITUS (Arms and head was itchy), APPLICATION SITE DISCOLOURATION (Faint pink mark where it was red), INJECTION SITE PRURITUS (Very itchy), INJECTION SITE URTICARIA (Became bumpy), INJECTION SITE RASH (Red rash on the injection site) and INJECTION SITE ERYTHEMA (Red rash on the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient put cold compresses on injection site and used cortisone cream.  The patient's second dose was scheduled for 28Aug2021.  Patient had a procedure for her Afib however it didn't work out. So on 07Sep2021 patient was going to cardiologist to see what needs to be done (medication or a procedure) to get her heart back in rhythm.
I went to bed and I felt OK I woke up about 1 o?clock and my head was exploring my body was aching and I was so thirsty I can?t explain it so I got up and I drank a bunch of water and seltzer I didn?t really want to take the Advil at that point because I had nothing in my stomach I just wanted to get back in bed. My legs kept cramping up because I was sweating so much I guess I was dehydrated this went on at three and then again at five. I finally got up at five and I took a piece of bread and two Advil drank some more water finally starting to feel better it was like having the virus all over again but much milder
16 month old patient received KINRIX; received KINRIX by mistake; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 16-month-old male patient who received DTPa-IPV (Kinrix) (batch number 7P5J5, expiry date 30th September 2022) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Pediarix (received 2 doses on an unknown date).   On an unknown date, the patient received the 3rd dose of Kinrix and Kinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown.   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 provided are as follows: Nurse reported that 16 months old patient received 3rd dose of Kinrix by mistake, which led to inappropriate age at vaccine administration and wrong vaccine administered. The patient's mother did not report any side effects or issues. The reporter reported that Kinrix was the 3rd dose of DTAP and 3rd of IPV.  Medicine of doctor (MD) was trying to catch up his patient who was behind on both.  The information regarding the previous vaccination of the patient was obtained from 2nd line agent after the transfer. No further events were reported at the time of the call. The reporter consented to follow-up by phone.
Patient received her 2nd dose of Moderna vaccine. No reactions reported from 1st dose. A few minutes after administration, patient stated feeling a racing heart rate. We had her sit down. Checked on patient a few minutes later, she stated trouble breathing, feeling dizzy, nauseous, and jaw pain. My partner called 911 and EMS came to check on patient, they then took her by ambulance to medical services.
a friend died from the vaccine; A spontaneous report  was received from a non health care professional, concerning her friend, who was administered Moderna's COVID-19 vaccine (mRNA-1273) and  died from the vaccine.  The patient's medical history,concomitant history, and lab data was not provided by the  reporter.   On an unknown date,  the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.  The patient experienced death after receiving the moderna mRNA1273 vaccine.  No further details were provided.  The action taken with the second dose of mRNA-1273 in response to the event was not applicable.   The  outcome of the events, died from the vaccine, were considered as fatal.; Reporter's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.; Reported Cause(s) of Death: Unknown cause of death
Complained of symptoms - 48 hrs after Adacel - worse left arm pain, distress, left side ache, extremely fatigue, mild HA, nausea, diarrhea, no rashes left forearm 21 x 40 mm erythema) mild swelling under skin induration 50x60mm, tender, sl. warm. Complained of pain mid clav -> mid shoulder
petechial rash to both lower legs; This is a spontaneous report from a contactable other healthcare professional. A 27-years-old female patient received bnt162b2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Batch/Lot number was unknown), dose 1 via an unspecified route of administration on an unspecified date in Mar2021, 3 weeks before the time of reporting, as DOSE 1, SINGLE (at the age of 27-years-old) for COVID-19 immunisation. The patient's medical history included vitamin B 12 deficiency from an unknown date and unknown if ongoing. There were no concomitant medications. The patient has had no other recent vaccinations or started any new medications that the reporter knows of. The patient experienced petechial rash to both lower legs on 17Mar2021, 5 days before the time of report. The reporter would like to know whether this has been reported before. The patient was due to her second dose of the vaccine the next day of reporting (i.e., 23Mar2021) but reporter would tell her to hold. The reporter said that the rash sounds pretty persistent, patient said they had it since 17Mar2021, and has done no treatment, and no medicine for it. The patient underwent lab tests and procedures which included lab test: results not provided on an unspecified date. The reporter stated that for the rash they were waiting on labs, but there was potential to be serious, unknown at that time. Outcome of the event was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Fainted a few mins after receiving the dose. Was sitting for his 30mins post vaccination due to allergy history and fell to the floor. Cut his upper lip during the fall. Will go to PCP to determine if he will need stitches for the lip. Woke within 15 seconds of fall, sweaty forehead and palms. Reported no similar incidents in the past after receiving a vaccine.
Fever, chills, vomiting, and hives 3 to 4 hours after administration. MD recommended diphenhydramine for hives.
One of two pts vaxed from same vial who exp pain @ inject site; pt vaxed 10DEC92; pain started & has been ongoing for approx 7 days; seen by MD-no redness, swelling or induration;
Pt. came in for office visit with complaint of a rash, patient had vesicles on skin and was diagnosed with vaccine induced varicella.
Dizzy fever burning up fingers and toes and one side of face and gums numb  Fatigue slight headache heart pounding and 92 bpm It is about 35 hrs since getting the shot and now i am just fatigued and sleepy
Arm became sore within 24 hours with slight swelling around injection site; symptoms progressed to moderate pain with more profuse swelling and localized erythema and heat; oral antibiotic and topical antibiotic administered at ER 36 hours post injection; swelling and pain worsened and patient admitted to hospital 48 hours post injection with diagnosis of cellulitis not ruling out reaction to vaccine. This was the newest Spikevax for 2023-2024.
C/o itchy skin (L) facial cheek, some slight redness noted. Also had itchy skin in face 2009 Dec for 1st H1N1 vaccination. administered 30mg BENADRYL elixir.
Adverse event:  ears "clogged up" i.e. filled with fluid. A common allergic reaction with me. Lasted several hours. Going away after a few hours.
Vaccine was given in error on 11/9/22 - patient should have been given Pfizer monovalent for 2nd dose in primary series.
Some of the vaccine (a drop) got on her arm; This spontaneous case was reported by a consumer and describes the occurrence of OCCUPATIONAL EXPOSURE TO PRODUCT (Some of the vaccine (a drop) got on her arm) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 25L20A and 16M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Topical) dosage was changed to 1 dosage form. On 01-Mar-2021, the patient experienced OCCUPATIONAL EXPOSURE TO PRODUCT (Some of the vaccine (a drop) got on her arm). On 01-Mar-2021, OCCUPATIONAL EXPOSURE TO PRODUCT (Some of the vaccine (a drop) got on her arm) had resolved.            Concomitant product information was not provided. Treatment information was not provided. Patient stated that lot number from the vaccine that got on arm was unknown.   This case was linked to MOD-2021-052911 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 22-Jun-2021: Follow up received on 22-JUN-2021. Updated reporter mail ID. On 05-Aug-2021: Follow-up received and confirmed lot numbers.
Rash on my chest; I guess the rash joined one another on my chest, inside my legs and both my upper arms; Cough; My left arm where I got the shot that arm, it was feverish, it was very hot; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient received first dose of BNT162B2, lot no. EL9262, via an unspecified route of administration (left arm) on 24Jan2021 at a single dose for COVID-19 immunization at a hospital facility. They gave her a dose that was recommended. Medical history and concomitant medications were not reported. The patient reported a reaction that she had to her first vaccine. It was Pfizer BioNTech COVID-19 Vaccine EUA and she had that on 24Jan2021 and she had a little cough the following day (25Jan2021) which she did not have before and then she didn't recover from the cough but she woke up on the 27th with a little bit of rash on her chest and she just kind of ignored it but within four hours she had not just a rash, she had she guessed the rash joined one another on her chest, inside her legs and both her upper arms. She started taking Benadryl and it took about 125 mg of the Benadryl over 30 hours before she was able to get rid of the rash. It happened three days later at her house. She treated herself with Benadryl. She was not experiencing any kind of breathing problems or anything that she was alarmed about. She only took Benadryl 25 mg when she first saw it because the rash was not severe but within four hours even after she took the 25 mg, the rash became very severe and her left arm where she got the shot that arm, it was feverish, it was very hot on Jan2021. She didn't know next step with her second dose. She felt like rash was severe. Her rash took over 30 hours and taking 125mg Benadryl to get rid of it. So, she didn't know how to prepare or what to expect. She was due to get it on 14Feb. The patient recovered from rash generalized on Jan2021, not recovered from cough, while outcome of other event was unknown.
Red, itchy area at injection site 1 week after. The day after I had redness and swollen ness at the injection site.
I had what I deemed to be normal side effects on day of injection and following day (headache, fatigue, etc). At around 11:30pm on May 1st 2021, I woke up with moderate-severe stomach cramping followed my repeated diarhhea and vomiting for the next five hours. Became dehydrated but decided against going to the ER and instead opted to sleep it off. At time of writing it is approximately 11am on May 2nd 2021. Vomiting and diarhhea have ceased but nausea persists.
This spontaneous report as received from a licensed vocational nurse refers to a patient of unknown age and gender. On 20-OCT-2014, the patient was vaccinated with RECOMBIVAX H B (dose, route of administration were not reported), lot # J008505, expiry date: 07-FEB-2016) that was improperly stored on unknown date. No adverse event was reported. This one of many several reports received from the same reporter. Additional information has been requested.
Case number PHEH2015US005064, is an initial spontaneous report received from a nurse on 13 Mar 2015 and with follow-up information from a nurse received on 28 Apr 2015. This report refers to a 13-year-old female patient. Past medical history and concomitant medication were not reported. The patient received only Men C, Y, W-135 liquid conjugate component of MENVEO (batch number: X14040, expiry date: Jan 2017), intramuscularly into right arm without being reconstituted with Men A lyophilized conjugate vaccine component on 11 Mar 2015 at 10:57. On the same day, the patient was also vaccinated with HPV (batch number unknown, other manufacturer). On an unknown date, after vaccinations, the patient presented with bloody bad nose. Outcome, seriousness and causality of the event were not reported. Follow-up information from a nurse received on 28 Apr 2015: New event (blood nose), patient's demographics (weight and height), vaccine details (site, time, expiry date), new suspect vaccine (HPV), new reporter details and other clinically relevant information updated in the narrative.
This spontaneous report as received from a registered nurse refers to a 42 year old female patient with sulfa allergy. The patient's medical history included ulcerative colitis. On an unknown date the patient was probably administered two doses of M-M-R II (doses, routes, and lot numbers not provided) on unspecified dates in the past. Concomitant therapies included LIALDA. On 11-NOV-2013 the patient's results of serologic testing demonstrated rubella antibody test "equivocal", rubeola antibody test negative and mumps antibody test negative. No treatment was given for the adverse event. The patient went to healthcare center for medical attention. The patient's outcome was reported as not recovered. The casual relationship was not reported. Additional information has been requested.
Metallic taste at 6 hours & headache 103 temp at 12 hours with chills and shakes  101 temp at 30 hours
chronic migraines began 2 days after.  persisted for couple months.  vocal cord dysfunction for 3 months and ongoing.  Bagan 1 week after second vacccine
Blurred vision - I could see up close with my glasses off, but my vision blurred with them on.
Baby was given Pfizer Monovalent covid vaccine vs Bivalent. This was her 2nd covid vaccine.  She is scheduled for her Bivalent covid vaccine 7/11/23.  No symptoms.  No adverse effect.   Mother was called and agrees to come in for the Bivalent dose 7/11/23.
8:15am received shot 9:15am forearms were itching stopped by 10:30am. 12:30pm I had severe dizziness, room was spinning and I was off balance. This came on and off until about 8pm to where it somewhat subsided.  7:30pm I had back pain.  10:30pm slight chills and shooting leg pains 12:30am bad chills (shaking), all over body pain and dizziness returned again. 7:00am head felt foggy with slight off balance still 12:00pm all symptoms subsided
Severe headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Severe headache) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Severe headache) (seriousness criterion medically significant). At the time of the report, HEADACHE (Severe headache) outcome was unknown.            No relevant concomitant medications were reported. No treatment information was provided.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
I experienced extreme fatigue 2 days after the Pfizer vaccine and I am still experiencing this fatigue 2 months after my 2nd dose.
tested positive for covid after he got the 1st dose last 03/04/2021; tested positive for covid after he got the 1st dose last 03/04/2021; muscle pain; This is a spontaneous report from a contactable male consumer (patient, self-reported).  A male patient of an unknown age received a first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number and Expiration date was unknown), via an unspecified route of administration, on 04Mar2021 as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It reported that, the patient tested positive for COVID-19 after he got the 1st dose on 04Mar2021. He also experienced muscle pain. His 2nd dose will be on 26Mar2021. On an unspecified date in Mar2021 the patient underwent SARS-CoV-2 test and result was positive. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Medical Assistant mistakenly gave a patient an IPOL vaccination in addition to their PENTACEL vaccination on 12MAY2022, causing the patient to receive an extra dose of IPV with no other reported adverse event; Initial information received on 13-May-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 6 months old male patient to whom it was reported that medical assistant mistakenly gave a patient an IPV (VERO) [IPOL] vaccination in addition to their diphtheria/tetanus/5 HYBRID AC pertussis/IPV(MRC5)/HIB(PRP/T) vaccine [Pentacel] vaccination on 12may2022, causing the patient to receive an extra dose of ipv with no other reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS B VACCINE (HEPATITIS B VACCINE) for Prophylactic vaccination.  On 12-May-2022, the patient received 0.5 ml dose of suspect IPV (VERO) (lot U1C571M; expiry date 17-Jun-2023) along with  0.5 ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot UJ542AAA, expiry date; 10-Jul-2022) via intramuscular route in unknown administration site for Prophylactic vaccination it was reported medical assistant mistakenly gave a patient an ipol vaccination in addition to their pentacel vaccination on 12may2022, causing the patient to receive an extra dose of ipv with no other reported adverse event (extra dose administered) (latency same day)  Action taken : not applicable.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
100.4degrees F fever, chills, body aches, chest pain, jaw pain, nausea, vertigo, headache No treatment  Onset 9 hrs after injection Duration 22hrs
Patient likely conceived with pregnancy day of vaccine administration. Her pregnancy has been complicated by oligohydramnios at early as 16 weeks, and eminent concern for loss of pregnancy. 1/16/2009 ER record received for 12/7/08 with DX: Vaginal bleeding at 18 wks pregnant, anhydramnios, mid trimester ROM, 2 vessel umbilical cord, possible TGA in fetus.  Prognosis poor. Pt presented with large amount of vaginal bleeding.
Patient says vaccine was given too high and pharmacist "injected into the nerve" and that she has permanent nerve damage and only about 80% range of motion despite being seen at ER, doctor office, and physical therapy.
Pt presented with pain in arm from vaccine. Itching, redness, warm, headache on one side of head. Red area 8 in. in width, and 5 in length below the injection site. Pain started 8 hours after injection. Tx: pt was given prednisone, and she will be monitored.
Vaccine went directly to my joints. Could hardly walk for about a day. Stiffness occurred and finally left on or about Sunday.
Case number PHEH2016US029325, is an initial spontaneous report received from a nurse on 07 Nov 2016. This report refers to a 78 years old female patient. Past medical history and concomitant medications were not reported. The nurse stated that, first temperature excursion of FLUCELVAX QUADRIVALENT  at 52 Fahrenheit for 01 hour occurred on 18 Oct 2016. Second temperature excursion occurred on 23 Oct 2016, dropped low 06 times to 34 Fahrenheit and lasted 30 minutes each time. The patient was vaccinated with FLUCELVAX QUADRIVALENT (batch number: not reported) at a dose of 0.5 ml, intramuscularly on 27 Oct 2016. Third temperature excursion occurred on 02 Nov 2016, down to 32.2 Fahrenheit three times over the course of 12 hours. Vaccine had been administered. It was unknown if vaccine was frozen. Nurse did not know which lot was given to which patient. No adverse event was reported following this medication error.
Within 2-3 minutes of vaccine administration c/o feeling hot/dizzy;  placed in supine position w/ legs elevated; pt c/o feeling sleepy became difficult to arouse, sternal rub caused her to opens eyes and answer questions w/ 1-2 word answers; VSS BP 120-144/80, HR 96 & regular; Resp 16 & non-labored; no hives; no rash; lungs clear;  Transported to ER via ambulance by 3:10 pm.  Per ER physician, ? syncope.  Symptoms resolved in ER and was discharged to home.