chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I have an irregular red splotch about 1.5 inches at the site of injection.  I have another irregular red splotch about 1 inch under the other red splotch that measures about 2 inches.  The red splotches feel warm to the touch, they do not itch but the area is a little sensitive to the touch but not painful.   The red splotches went away after 3 days but returned on the 10th day after receiving the vaccine.
Dizziness, Headache, Diarrhea, NauseaVomiting, FATIGUE/SOB WITH HX OF ASTHMA Narrative:
The patient medical history and concomitant medications were not reported.  It was reported that patient got the first dose of Pfizer vaccine on 20Jan2021 and yesterday, with a week from the dose, he don't think it was related but he basically woke up and ended up getting very sick having like 101 degrees fever, vomiting, body ache. And he was really serious about quarantining, patient was a teacher and we just teach virtually currently and he was very just like unsure about where he would have got-ten anything and patient was able to get a COVID test today but it's not a rapid test, so he haven't gotten his results. But he just kind of want to reach out as far as like getting his second dose if that was still like okay to do, if that has been seen in anybody else. patient feel much better today, he don't, he likely haven't had a fever, still just have like some fatigue, kind of like normal after being really sick. patient took a Tylenol and have no idea about LOT and expiration date. The outcome of the a week from the dose, woke up and ended up getting very sick, 101 degrees fever recovering and for vomiting and body ache was unknown and for the event fatigue was not recovered.  information on the lot/batch number has been requested.  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 have been completed and no further information is expected.
0944 pt c/o lightheadness, sweaty, clammy. physician at vaccine clinic saw pt at that time. b/p 129/70 HR 94 O2 100% on room air. pt was laid down flat on a stretcher.  0946 pt states felt better. b/p 123/71 hr 86 O2 99% 0948 pt states better 123/82 hr 90 O2 99% 0952 b/p 128/78, hr 97, O2 99% 0955 b/p 122/75, hr 95, O2 100%. given water. physcian saw pt again and discharged pt.
Pt recvd vax 23OCT92 & following vax found to have allergies to gluten & yeast; w/in hrs following vax devel fatigue, hoarseness, enlarged cervical lymph nodes & itching over most of body;
Infant had a 30 second seizure after unconsolable screaming.  She had an immediate temperature spike and fever, thereafter.  She was taken to the emergency room.
mom reports pt cried inconsolable from 1AM to 115PM approx 15hr p/the shots were given;also pt had a fever 102.5-102.6 for about 12hr p/vax;
Sore injection site for 2+ days.  Chills and fatigue onset 8 hours post injection
Information has been received from a physician concerning a 14 year old female who on 27-MAR-2007 was vaccinated with a first dose of Gardasil (lot not reported) and a second dose on 21-MAY-2007 (Lot# 657737/0522U). There were no concomitant medications. During this second injection on 21-MAY-2007 the patient experienced tingling and numbness in her arm immediately upon injection which continued for the rest of the day. It was her entire arm, but "not to the point of non-function". She needed no prescription treatment and subsequently recovered from tingling in arm and numbness in her arm. Additional information has been requested.
pt vax in 1995 & in 1999 pt lab tests indicated pt failed to seroconvert. addl info requested
Redness and slight swelling of face were first symptoms on 10/08/13. At 7:00 AM on 10/09/2013 there was red rash all over my chest and abdomen that remains as of today, 10/13/2013, and has worsened, including a rash on my legs.  I have a doctor's appointment tomorrow, 10/14/2013.
Tired, took nap when got home. ~1:30pm body aches. Some loose stool.  ~4:pm vomiting. Vomited until dry heaves for an hour.
Diagnosed with Shingles; This case was reported by a physician via call center representative and described the occurrence of shingles in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In August 2019, the patient received the 1st dose of Shingrix. In December 2019, less than 4 months after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were reported as follows: The patient received 1st dose of Shingrix and was diagnosed with Shingles in December 2019. Reporter inquired how to proceed with 2nd dose of Shingrix. Reporter did not consent to follow up.
First 2 doses gave side effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (First 2 doses gave side effects) in a  patient of an unknown age and gender 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (First 2 doses gave side effects). At the time of the report, VACCINATION COMPLICATION (First 2 doses gave side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   No relevant concomitant medications was reported. Treatment information was not provided.   This case was linked to MOD-2021-350562 (Patient Link).
Initial misuse report received from a health care professional on 15 November 2013. A female patient (date of birth and age at the time of event was not reported) had received subcutaneously a dose of FLUZONE (batch number, dose number and site of administration not reported) on 06 November 2013. The patient's medical history and concomitant medications were not reported. It was reported the patient had received the vaccine subcutaneously instead of intramuscular. On 06 November 2013, same day of vaccination, the patient developed red, swollen, sore at injection site with lump at injection site. As of 15 November 2013, the patient continues to had "hard knot" that was sore at injection site. Laboratory tests and corrective treatments were not reported. The event redness and swelling resolved on an unspecified date and the event lump, knot at injection site did not recover. List of documents held by sender: None  Follow-up information received from health care professional on 21 January 2014. No new information was provided.
30-45 minutes after vaccine she developed dizziness, a feeling of warmth, nausea, and vomiting. All but the nausea resolved in 10 minutes, nausea took 4 hr to go away (on it's own). No swelling of lips or tongue or any shortness of breath. She did not seek medical attention, having already left the clinic. She called the next day to report her symptoms.
Breakthrough case admission after 3 vaccines Pfizer 6/28/21 Lot# EN6207;  Pfizer 7/23/21 Lot# Ew0173;  Pfizer 12/14/21 Lot# 33130BA
Patient received Moderna Spikevax In combination with high dose flu vaccine. Family reported that about 2 days later she became weaker, achy and lower appetite. She worsened the next week but refused the emergency room. She was found unresponsive on  morning Wednesday October 18th and passed away on route to the ER in an ambulance. Patient had been declining tests or specialist care for a number of years. She was DNR.
Patient presented to the ED and was subsequently hospitalized for renal colic on right side, stent placement within 6 weeks of receiving covid vaccination.
Heart rate elevated; This spontaneous case was reported by a consumer and describes the occurrence of TACHYCARDIA (Heart rate elevated) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced TACHYCARDIA (Heart rate elevated). At the time of the report, TACHYCARDIA (Heart rate elevated) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Jan-2021, Heart rate: 124 (High) Normal resting rate is 70. On 08-Feb-2021, Heart rate: 90 (High) 90-110 beats per minute.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Left arm swelling and cellulitis, seen in office and prescribed antibiotics and over the counter pain medication
HIVES, UNSURE PARENTS RESPONSE, DID NOT TELL MD UNTIL 15 MONTH VISIT
This case was reported by a other health professional and described the occurrence of underdose in a 19-year-old female patient who received HAVRIX pediatric (batch number N4341 ?, expiry date 19 February 2016). On an unknown date, the patient received HAVRIX pediatric .5 ml. On an unknown date, an unknown time after receiving HAVRIX pediatric, the patient experienced underdose. On an unknown date, the outcome of the underdose was unknown. It was unknown if the reporter considered the underdose to be related to HAVRIX pediatric. Additional informations: This 19 years old inadvertently given a pediatric dose of HAVRIX (720 EL.U).
Patient and mother report that teen broke out in hives approximately 2 hours after receiving vaccine. On torso, face, arms and legs. Very, itchy.
Numbness in left cheek, occasionally to left eye lid to upper left lip. Numbness comes and goes.   Currently still feel numbin face.
Herpes simplex virus reactivation- herpes simplex outbreak covering entire mouth making it impossible to eat or drink without pain for nearly a week, thus far
Information has been received from a registered nurse who knows by third hand knowledge that a female who was vaccinated with a first dose of GARDASIL at another office, woke up in the middle of the night with itchy red eyes. The other office does not want the patient to receive the second dose of GARDASIL. The nurse did not want to answer any questions since she knows this by third hand knowledge. Additional information is not expected.
Bad headache, dizziness, achy, vomiting (3x)   Lasted until about midnight, Monday, Feb.22.  Felt totally recovered by 9AM Tuesday.
Approximately 10 minutes after vaccine administration, patient experienced heavy breathing followed by diminished hearing and tingling in hands.  He became worried about the symptoms and sat on the floor.  After sitting on the floor, his vision diminished (became fuzzy) and he became nauseated. The previous symptoms cleared but he started to sweat in the head area.
ABOUT 45 MINUTES AFTER THE SHOT PATIENT WAS SHOPPING IN STORE AND HAD A SYNCOPAL EPISODE WITH LOSS OF CONSCIENCENESS AND VOMITING
Patient complained of hives From right shoulder to hand. Patient complained of fever 11-14-07 up to 101.2 no complaint of temp today. Right arm sore and warm to touch. Patient reports no new s/s as of now 11/15/07 at 1400.
Fever, nausea/covid test result= Positive; Fever, nausea/covid test result= Positive; This is a spontaneous report from a contactable nurse (patient). A 24-year-old female (no pregnant) patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date were not provided), via an unspecified route of administration in arm Left on 17Dec2020 02:30 at single dose for COVID-19 immunisation. Facility where the most recent COVID-19 vaccine was administered was hospital. The patient's medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19.  The patient experienced fever, nausea on 20Dec2020 12:00. Since the vaccination, has the patient been tested for COVID-19. The patient underwent lab tests and procedures which included PCR: positive on 21Dec2020, POCT: positive on 21Dec2020, Nasal Swab: positive on 21Dec2020. (reported as '[{covid test type post vaccination= Nasal Swab, covid test name post vaccination= PCR, covid test date= 21Dec2020, covid test result= Positive}, {covid test date= 21Dec2020, covid test type post vaccination= Nasal Swab, covid test name post vaccination= POCT, covid test result= Positive}]'). No treatment received for the adverse event. The patient not received any other vaccines within 4 weeks prior to the COVID vaccine. The outcome of events was not recovered.  Information on the Batch/Lot number has been requested.; Sender's Comments: Based on the information currently available, a lack of efficacy with BNT162B2 in this patient might not be completely excluded.
I had the usual redness and swelling on arm and a slight rash on some of my skin and if I scratched it I would get a weird reaction and my skin would look like mosquito bites or poison ivy and it got welts. About 3 days later I started feeling very ill and very tired and nauseous and sore. After 5-6 days maybe longer I was with headache and joint pain. 2-3 weeks after that my stomach started cramping and I had blood in stool and nausea and couldn't eat. It went away for a couple of days but came right back. My whole abdomen was very sore and tender. I went to a walk in clinic and they said it was just diarrhea and nothing to worry about and probably a tear in my bottom. I don't want to go and get a bunch of debt to see a doctor. If I get too stressed out I start getting really sore and have to lay down and not shift weight too quickly.
Pulmonary embolism numerous in both lung happened  with 48 of second dose; second dose was administered on 15Mar2021; first dose was administered on 01Mar2021; second dose was administered on 15Mar2021; first dose was administered on 01Mar2021; This is a spontaneous report from a contactable consumer (patient). A 74-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided) via an unspecified route of administration on 15Mar2021 as a single dose for COVID-19 immunisation. Medical history included Lupus, glaucoma, hypertension, irritable bowel syndrome (IBS), fibro and allergies to Gluten. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient has not had any vaccine in four weeks but took other medications in two weeks (unspecified). The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 01Mar2021 13:15 for COVID-19 immunization. On 17Mar2021 20:00, the patient experienced Pulmonary embolism numerous in both lung happened with 48 of second dose. The event resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization (Prolongation of existing hospitalization) as the vaccine was received during existing hospitalization, Life threatening illness (immediate risk of death from the event). Treatment was given in response to the event which included bed rest and pain medications. The patient underwent COVID test post vaccination via nasal swab on 24Mar2021 and was negative. The outcome of the event pulmonary embolism was recovering.
felt bad like I wanted to die; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of feeling bad in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Flu unspecified (Flu vaccine) for prophylaxis and COVID-19 VACCINE (COVID VACCINE) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine, Flu vaccine and COVID VACCINE. In DEC-2022, an unknown time after receiving Shingles vaccine and Flu vaccine, the patient experienced feeling bad (Verbatim: felt bad like I wanted to die).The outcome of the feeling bad was not reported.   It was unknown if the reporter considered the feeling bad to be related to Shingles vaccine and Flu vaccine.  It was unknown if the company considered the feeling bad to be related to Shingles vaccine and Flu vaccine.   Additional Information: GSK receipt date: 07-Mar-2023 This case was reported by a patient via interactive digital media. The patient was due to get second shot this month.  The patient felt really bad in December when got the first shot, but also had the Covid, Flu and Shingles shot the same day.  The patient felt like zI wanted to die. Hopefully this time with just the one it won't be bad. The follow up would not possible, as no contact, details were available.
SICK; 102 FEVER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. On an unspecified date, the patient experienced sick, and 102 fever. Laboratory data (dates unspecified) included: Fever (NR: not provided) 102. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the 102 fever, and sick was not reported. This report was non-serious.
Received injectafer today and developed severe back pain 25 minutes into the IV. Back pain has not subsided, has continued to worsen. Injectafer prescriber has advised to take a 5mg of Cyclobenzaprine HCL tablet for relief. Pain in back radiates from lower left region. I have been receiving Injectafer monthly for years and never had an issue before. Wondering if the Moderna booster I received 6 days ago is related to this new issue? I am female and 41.5 years old.
Expired Kinrix administered; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 4-year-old male patient who received DTPa-IPV (Kinrix) (batch number E2L54, expiry date 03-MAR-2023) for prophylaxis.   On 19-APR-2023, the patient received Kinrix. On 19-APR-2023, an unknown time after receiving Kinrix, the patient experienced expired vaccine used (Verbatim: Expired Kinrix administered). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt date: 28-APR-2023 The reporter reported that the patient received the expired Kinrix vaccine, which lead to expired vaccine used. The reporter did consent to follow up.
Pt. described (L) arm pain, swelling, fever 12 hrs after injections, fever of 102.8 day after and again this morning. On exam by PCP found (L) proximal arm is swollen, warm to touch, but nonerythematous. Tender with palpation. No streaking erythema noted, no adenopathy present. Pt instructed ice for 20 minutes q 4-6 H for several days. Ibuprofen 800mg 3x daily as needed for pain and swelling. BENADRYL q 6-8H as well.
Nausea on and off day after vaccine.; Fatigue; Chills; One episode of vomiting evening after vaccine; This is a spontaneous report from a contactable consumer, the patient. A 66-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN 6202) via an unspecified route of administration in the left arm on 28Feb2021 at 09:45 (at the age of 66-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure and known allergy to penicillin. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received other vaccines within four weeks prior to the vaccination. Concomitant medications included tetanus vaccine (MANUFACTURER UNKNOWN) taken on 08Feb2021 in the left arm for an unknown indication, amlodipine besilate (NORVASC), acetylsalicylic acid (ASA) and multivitamin (MANUFACTURER UNKNOWN); all from unknown dates for unknown indications and unknown if ongoing. On 28Feb2021, evening after vaccine, the patient experienced one episode of vomiting. On 01Mar2021 at 19:15, the patient experienced nausea on and off day after vaccine, fatigue and chills. The events did not result in doctor or other healthcare professional office/clinic visit, 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 on and off day after vaccine, one episode of vomiting, fatigue and chills were unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Moderna 3/15/21, 4/14/21, 10/27/21. Positive on 9/22/22
Second dose: had this same thing with the second dose where her arm was red and swollen really big at that spot; Second dose: had this same thing with the second dose where her arm was red and swollen really big at that spot; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 60-year-old female patient received bnt162b2 (BNT162B2), administration date 17May2021 (Batch/Lot number: unknown) at the age of 59 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Blood pressure high" (unspecified if ongoing); "Borderline diabetes" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose:1), for COVID-19 Immunization, reaction(s): "didn't have a reaction with the first dose".  The following information was reported: VACCINATION SITE SWELLING (non-serious), VACCINATION SITE ERYTHEMA (non-serious) all with onset 2021, outcome "unknown" and all described as "Second dose: had this same thing with the second dose where her arm was red and swollen really big at that spot".  Additional information: Prior Vaccinations (within 4 weeks) and AE(s) following prior vaccinations: None. History of all previous immunization with the Pfizer vaccine considered as suspect: None. There were no other additional vaccines administered on Same Date of the Pfizer Suspect. Events did not lead to visit Emergency Room and Physician Office. There is no Family Medical History Relevant to AE(s) and there were no Relevant Tests. The caller got her second dose on 17May2021, and they said just to put some ice on it.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt suffered a prolonged seizure 24 hrs after receiving, presented in status epilepticus x 2 hrs. Seizure felt likely to be secondary to UTI but Pt's T max was 101. Neurologist could not rule out a vaccine related event. Currently unk whether she will have residual deficits.
Sore arm; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) (batch number CD9MZ, expiry date 4th September 2022) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (1st dose received on 19th January 2020, refer case US2020AMR080036).   On 15th April 2020, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On an unknown date, less than a month after receiving Shingrix, the patient experienced pain in arm. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details provided as follows: The sore arm still not resolved at the time of reporting. Patient was also having trouble laying down on that arm. Pain with second dose was lot more than the pain with first dose. No other details were provided.