chrisvoncsefalvay/vaers-outcomes huggingface dataset:
a welt the size of a ping pong ball developed below the injection site; entire arm in pain with veins swelling; entire arm in pain with veins swelling; This is a spontaneous report from a contactable nurse, the patient. A 50-years-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number unknown), via an unspecified route of administration, administered in the left arm on 12Feb2021 at 15:00 (at the age of 50 years-old) as single dose for COVID-19 immunisation. Medical history included diabetes mellitus from an unknown date and unknown if ongoing.  The patient has no allergies to medication, food or other products. The patient's concomitant medications were not reported.  The patient previously received the first dose of BNT162B2, via an unspecified route of administration, administered in the left arm on 22Jan2021 at 16:00 (at the age of 50 years old) for COVID-19 immunisation. Prior to the vaccination the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 13Feb2021 at 00:00 (reported as 12:00 AM), two days after the second dose (as reported), the patient experienced entire arm in pain with veins swelling, and on 14Feb2021 (exact time unknown), day 3 after the second dose, a welt the size of a ping pong ball developed below the injection site. The patient reported the events as non-serious. Therapeutic measures were taken as a result of entire arm in pain with veins swelling and a welt the size of a ping pong ball developed below the injection site included unspecified home pain medications and creams. The outcome of the events entire arm in pain with veins swelling and a welt the size of a ping pong ball developed below the injection site was recovering. It was also reported that since the vaccination the patient has not been tested for COVID-19.  The batch/lot numbers for the vaccine, PFIZER-BIONTECH COVID-19 MRNA VACCINE, were not provided and will be requested during follow up.
Client is 6 years old. He received Pfizer (adult) vaccine dose, 0.3ml/30meq. Client should have received Pfizer (peds) vaccine dose, 0.2ml/10meq. At the time of departure, there were no signs/symptoms noted.
sensitivity in arm at the site of injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (sensitivity in arm at the site of injection) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.    Co-suspect product included non-company product VITAMINS NOS (MULTIVITAMINUM) for an unknown indication.    No Medical History information was reported.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient started VITAMINS NOS (MULTIVITAMINUM) (unknown route) at an unspecified dose. On an unknown date, the patient experienced VACCINATION SITE REACTION (sensitivity in arm at the site of injection). At the time of the report, VACCINATION SITE REACTION (sensitivity in arm at the site of injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment details were added.
Information has been received from a nurse concerning a 72 year old female who on 14-AUG-2007 was vaccinated with a single dose of ZOSTAVAX. Later that same day the patient experienced a fever and felt tired for a couple of days.  The patient did not contact the office about the events until her next doctor's appointment. The patient reported the she "felt better a few days later" There was no product quality complaint. Additional information has been requested.
1st doe on Nov2019, did not receive 2nd dose; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received into left arm (0.5 ml) in November 2019).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 12-SEP-2022 Reporter's comment: The patient self-reported this case. The patient had not yet received the second dose of Shingrix vaccine. The patient planed on getting the second Shingrix vaccine.  The patient did not want to provide any further demographics. No HCP (Health Care Professional) for follow-up. The reporter did not consent to follow-up. Additional Supportive Information: Till the time of reporting the patient did not receive the 2nd dose of Shingrix, which led to Incomplete course of vaccination.
Migraine/headache for 3 days. Dull, mild headache has continued - on day 6 chills, exhaustion, overall sick feeling 2 days.
I contracted the COVID-19 virus after having all three doses of the vaccine. I started to have sweats, fever of 101, Asthma worsened. After having the second booster dose on 04/06/2022 (lot number FK9895) is when the symptoms of spider veins then is accompanied with a lump on the areas. Still awaiting the doctors appointment.
It was reported that a child had been vaccinated with Tripedia on 8/23/02. The site was warm to the touch following administration of the vaccine. On /26/02, the pt's mother ret'd to the Dr's office with the pt, who was exhibiting a red, swollen area on her L arm, approx 3-4 inches in diameter. It was not reported whether the pt recovered.
9 days after receiving MMR/Varicella as separated injections developed temp to 102 degF then generalized macular blotchy rash. Temp resolved after 4 days, rash after 7 days.
I noticed my son became unresponsive and looked like he was staring.  He did not move unusual.  He cried after the immunizations for 3 days.  On Monday 8/30/10 he had 3 seizures.
A little bit of rash in both injections; Redness around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (A little bit of rash in both injections) and VACCINATION SITE ERYTHEMA (Redness around the injection site) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history information  was reported.  Concomitant products included FISH OIL for an unknown indication.    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 SITE RASH (A little bit of rash in both injections) and VACCINATION SITE ERYTHEMA (Redness around the injection site). At the time of the report, VACCINATION SITE RASH (A little bit of rash in both injections) and VACCINATION SITE ERYTHEMA (Redness around the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications also included supplements and vitamins.  The treatment information was  not provided.   This case was linked to MOD-2021-294674 (Patient Link).
Not a true adverse effect, except we determined that the vaccine administered to patient was indicated for patients over 65 years old and she was 63 at the time.
I26.99 ACUTE PULMONARY EMBOLISM 4/13/2022 ACUTE DVT OF RIGHT PERONEAL VEIN I82.451 ACUTE DVT OF RIGHT PERONEAL VEIN 4/13/2022 ACUTE DVT OF RIGHT PERONEAL VEIN I95.9 HYPOTENSION 4/7/2022 ACUTE DVT OF RIGHT PERONEAL VEIN I26.99 ACUTE PULMONARY EMBOLISM 4/13/2022 GASTRIC MASS I82.451 ACUTE DVT OF RIGHT PERONEAL VEIN 4/13/2022 GASTRIC MASS I95.9 HYPOTENSION 4/7/2022 GASTRIC MASS
Information has been received from a registered nurse concerning a 72 year old female consumer with on known drug allergies who on 10-JAN-2008 was vaccinated SQ with 0.65mL of zoster vaccine live (Oka/Merck) (lot #658862/1415U). Subsequently, shortly after vaccination the patient experienced severe arthritic symptoms. On an unspecified date the patient was seen by her physician. There were no lab studies performed. It was noted that the patient took MOTRIN for her symptoms. However, the physician did not want the patient to take MOTRIN. At the time of the report the patient had not recovered. There was no product quality complaint involved. Additional information has been requested.
sugars went up; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD GLUCOSE INCREASED (sugars went up) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M208) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes, Disease Crohns, COPD and Hard of hearing.    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced BLOOD GLUCOSE INCREASED (sugars went up). At the time of the report, BLOOD GLUCOSE INCREASED (sugars went up) outcome was unknown. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications were reported. The patient continued to take regular medications.
There was a large red rash on the patient's upper arm about 3 inches in diameter. It was warm to the touch and the child said it was uncomfortable.
Started spotting and I thought that was a normal beginning of a menstrual cycle on birth control but I am still bleeding a month later. I don?t have pain or cramps but bleeding for a month is strange
The day of the vaccine I had difficulty breathing, chills, and a fever. A few weeks later, I went to the ER for difficulty breathing and was diagnosed with bronchitis
The patient was administered the High Dose Fluad vaccination at age 64 and 10 months.  The patient should have received the Flucelvax vaccine.  I contacted the patient to inform her of the higher dose flu vaccine.  She stated that she was not experiencing any adverse reactions.  She only felt some soreness in her left arm.  The patient did not voice any other complaint.  I educated the patient regarding side effects and if escalted to contact the clinic and her physician.  She stated 'I don't think that will be necessary."
No adverse event; She states the monovalent was 0.25 ml/A nurse gave 0.25 ml instead of the 0.5 ml today 26-Apr-2023; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (She states the monovalent was 0.25 ml/A nurse gave 0.25 ml instead of the 0.5 ml today 26-Apr-2023) and NO ADVERSE EVENT (No adverse event) in an elderly patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 26-Apr-2023, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 26-Apr-2023, the patient experienced WRONG PRODUCT ADMINISTERED (She states the monovalent was 0.25 ml/A nurse gave 0.25 ml instead of the 0.5 ml today 26-Apr-2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (She states the monovalent was 0.25 ml/A nurse gave 0.25 ml instead of the 0.5 ml today 26-Apr-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (She states the monovalent was 0.25 ml/A nurse gave 0.25 ml instead of the 0.5 ml today 26-Apr-2023).    No concomitant medications was reported. No treatment drug details was reported. This case belongs to 6th out of 6 patients as described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-721461 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-721461:Patient 1
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid from 03Oct2023 to 07Oct2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous case reported by a consumer, describes the occurrence of pain in a male patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. The patient's past medical history included no adverse event. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19  vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced pain. At the time of the report, pain outcome: unknown/not provided The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. Sender's comments: This case linked to MOD-2021-059921 (E2B linked report): Daughter case.
Had like a ball developing in my head and brain, a round ball; Developed a little knot or a little ball on the top of my head; Had like a ball developing in my head and brain, a round ball; Developed a little knot or a little ball on the top of my head; This is a spontaneous report from a contactable consumer (patient). A 72-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN6205; Expiration Date: Jun2021), first dose via an unspecified route of administration on 08Mar2021 as 0.3 mL (SINGLE DOSE ) for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Patient had like a ball developing in his head and brain. A ball developed, a round ball. A week later (Mar2021) it developed a little knot or a little ball on the top of my head. No treatment for the events. The outcome of the events was unknown.
I am in bed for several days; Initial information was received on 30-Sep-2021 regarding an unsolicited valid Social Media non-serious case received from a Patient.  This case involves a patient (unknown age and unknown gender) who was in bed for several days (illness) while receiving INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number not reported, and expiry date not provided] via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient was in bed for several days (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "Every year that I get the flu shot. I am in bed for several days and every year that I don't get the flu shot. I don't get sick at all".  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.   At the time of report, the outcome of event was unknown.  There will be no information available on batch number for this case.
Extreme dizziness, nausea, mild headache.  No treatment, just rest and taking it easy.  It happened several times, every few weeks for about 1 1/2 months.  Still have feelings of dizziness coming on but it doesn't get as bad as it had been.  Doctor thinks it might be migraines or BPPV?
This patient came in on 01.19.2022 to see Dr. and got her second dose of primary vaccines (Pediarix - DTaP, hep B, IPV, hib, PCV, and flu). First dose of primary vaccines was given at 6mo0days on 12.03.2021. The CDC recommends if the vaccine was given more than four days before the recommended minimum due date (01.28.22 per system), then you will repeat dosage at the recommended interval. I spoke with MDs for their recommendations as pediatricians in clinic. Dr. believes that this is not a true error, as children receive an extra hep B dosage with the normal intervals. Due to this patient being late to receiving the first primary dose of vaccines, this is what is equating the "error". Also, the human body can tolerate an additional hep B vaccine dose. Dr. stated that due to patient needing to come in within the next four weeks for their second flu shot, that when they come in for that they could get the next series dosage. This needs to happen AFTER February 19th. After the date February 19th, this patient can receive her second flu shot, third pediarix dosage, third PCV, and third HIB. This patient has an appointment on February 18th where doctor has okayed the patient to receive her next dose at that appointment.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP).  A 55-year-old male patient received BNT162b2 (BNT162B2), on 13Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 55 for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Cardiomyopathy" (unspecified if ongoing); "OSA" (unspecified if ongoing); "low back pain" (unspecified if ongoing); "Known allergies : Antihistamines" (unspecified if ongoing), notes: Known allergies : Antihistamines. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient received antiviral treatment for Covid-19 with Paxlovid from 13Jul2022 to 17Jul2022. Rebound symptoms after being done with paxlovid.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product bnt162b2 to the reported drug ineffective and COVID-19 cannot be ruled out.
Sudden onset of feeling the need to have diarrhea or vomit with near syncopal episode. Lasted about 15-20 minutes. Resolved for a few minutes after having diarrhea. Feeling of dizziness and lightheadedness returned about 5 minutes later. Laid down for about an hour and had increased fatigue for the next few hours. Went to bed for the night and had no symptoms after waking in the morning.
Local reaction with 4 inches x 6 inches of warm and indurated skin left triceps at site of VARIVAX.
After receiving the vaccination I had a cough and runny nose. I also ran a slight fever and diagnosed with Covid 19.
Fainting 24 hours after receiving 2nd dose of Pfizer vaccine. Started feeling lightheaded, dizzy, broke out into a sweat and passed out for approximately 15 seconds. EMT called and observed at scene; transported to ER for additional observation. Received IV fluid and monitoring at ER and discharged later the same day.
She became extremely lethargic and ghostly white.  She then started experiencing shortness of breath and was taken to ER.  Her left leg also became swollen and very red.
R09.02 HYPOXIA 9/10/2021 ANEMIA R09.02 HYPOXIA 9/10/2021 ANEMIA R09.02 HYPOXIA 9/10/2021 ANEMIA
Onset of systemic body aches & extreme fatigue started the afternoon of infection.  That night I had severe sweats & chills , severe body pains , headache,  no taste or smell & caulking dry sensation in mouth . This continued for 2 days  then a hive like itchy rash started around neck areas & spread over the rest of body which resembles small boils or pimples but extremely itchy & painful.  Have had severe head & neck pain & very fatigued,  no appetite no taste or smell .  Also had diarrhea & emesis once on 4th day following shot
Pt had IM injection in left arm. Arm became 4+ edema around to back of and down arm. As well as very painful.  11/16/09 Discharge summary received for DOS 10/27/09-10/30/09. Final DX: Recent diarrhea with history of Clostridium difficile and left upper extremity pain and swelling secondary to Pneumovax. lc  11/16/09 Patient developed persistent diarrhea two months ago and was previously diagnosed with Clostridium difficile. The patient was treated with Flagyl which caused nausea and vomiting and vancomycin that caused a rash.  She was hospitalized for further evaluation. No samples were obtained because patient did not have bowel movements.  While hospitalized the patient received IM Pneumovax vaccine on her left upper arm and she developed swelling and unusual pain. The patient was treated with medications for her pain and swelling, and occupational therapy and her left upper arm pain improved.  12/24/09 Medical records received for date 10/29/09. Consult on LUE pain after vax. Assessment: (+)swelling,(+)warm to touch, ROM WNL. DX: LUE pain secondary to acute reaction from IM vax.  Additional consult gave dx of cellulitis.
Exposed to 82.62 F for 15 minutes. Believes the door was left open. Vaccines were administered after the excursion with no adverse event was reported; Initial information received on 16-Jun-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 19 months old female patient who experienced exposed to 82.62 f for 15 minutes. believes the door was left open. vaccines were administered after the excursion with no adverse event was reported while receiving vaccine IPV (VERO) (IPOL).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect IPV (VERO) at a dose of 0.5ml with lot T1871M and expiry date: 10-Oct-2022 via unknown route in unknown administration site for Immunization.  On 23-Feb-2022 the patient developed a non-serious exposed to 82.62 f for 15 minutes; believes the door was left open and vaccines were administered after the excursion with no adverse event was reported (product storage error) (unknown latency) following the administration of IPV (VERO).   Action taken: not applicable.  Outcome: Unknown   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.; Sender's Comments:  01148666I: 01148676: 01150238: 01150239:
Fever, chills, rigors, hot flashes, nausea, soreness, aching.