chrisvoncsefalvay/vaers-outcomes huggingface dataset:
stop the itching/severe itching; redness like she was burned; chills; fever; take the heat out of her arm; She did not sleep much Friday or Saturday night since it was miserable and could not do much with it; a spot about 3 or 4 inches around that was bright red; This is spontaneous report from a contactable consumer (patient). An 82-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in left upper arm on 01Oct2021 11:15 (Batch/Lot Number: FY8841) (at the of 82 years old) as dose 3 (booster), single for COVID-19 immunisation. There were no patient medical history. Prior vaccinations, probably within 4 weeks, she got the regular flu shot (in 2021), she does not know the name of it or have lot number, stated that its the one for older people. The patient received the first dose of bnt162b2 (Covid-19 vaccine)  on 03Feb2021 (Lot: EL9265) and the second dose of bnt162b2 (COVID-19 vaccine) on 22Feb2021 (Lot: EL9262), both for COVID-19 immunisation. With the second COVID vaccine she had a mild irritation but it was tolerable. She had a severe reaction to the COVID vaccine booster shot. She was asking what can be done to take the heat out of her arm and stop the itching. She was advised to contact health care professional. Severe reaction started in the middle of the night on 02Oct2021. She described the reaction experiencing fever, chills, severe itching (medically significant), and redness like she was burned (medically significant). Redness was still there, itching was mild, she did not think she has any more fever or chills. She did not sleep much on Friday or Saturday night since it was miserable and could not do much with it. She was in the military and with all the shots she never had a reaction like this. She went to the doctor this morning and they indicated that she may want to put Benadryl cream on it to possibly lessen the itching and redness. She has a spot about 3 or 4 inches around that was bright red. No additional vaccines administered on same date of the Pfizer suspect. Events required a visit to Physician Office. The outcome of the events fever, chills was recovered; event redness was not recovered; event itching was recovering; and unknown outcome for the other events.  Follow-up attempts are completed. No further information is expected.
Right Leg spasms/twitching 5/20 around 8pm  went away by 11pm.  Next day, 5/21, my upper right lip constantly have spasms/twitching. Lasted around the clock all day and throughout the evening into bedtime. Next day 5/22 when I woke up it wasn?t present. These affects very unusual because I?ve never had them before.  I did have the typical fever/chills/lethargy.  Thought I would share...since I didn?t know /realize there was a method of sharing unusual symptoms from Moderna vaccine.
FLUSHING OF THE SKIN AND ITCHING GENERALIZED  ALLERGIC REACTION WITH SKIN RASH SECONDARY TO IM DRUG AND VACCINE
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Jan2021 at 16:00 as dose 1, single (Lot number: EL9261), in left arm, on 09Feb2021 at 16:00 as dose 2, single (Lot number: EM9709), in left arm and on 12Oct2021 at 17:30 as dose 3 (booster), single (Lot number: FE1304) at the age of 68 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 14Apr2022 at 16:00 as dose 4 (booster), single (Lot number: 065k21A), in left arm for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The patient's relevant medical history included: "Brochiectasis" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "Osteoarthritis" (unspecified if ongoing); "Chronic sinusitis" (unspecified if ongoing); "Cholesterolemia" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE; SINGULAIR; VITAMIN D3; B-12; ATORVASTATIN; AZITHROMYCIN. Past drug history included: Levofloxacin for Allergy; Cefapime for Allergy.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient received COVID 19 treatment from 11Jul2022 to 15Jul2022. Recurrence of COVID symptoms: congested sinuses, cough, headache, fatigue.
Pt complained of faintness, sob, heaviness and heart racing. Injected 0.3 epinephrine and called 911. Paramedics arrived and checked vitals. Pt was not transported and allowed to leave at 11:25.
Dose 1: 12Jan2021 04:30 PM; dose 2: 04Feb2021 10:30 AM; Felling Dizzy; Disoriented, Could not finish the drive home due to disorientation; Emotional; Crying; Nausea; Tired; Dose 1: 12Jan2021 04:30 PM; dose 2: 04Feb2021 10:30 AM; This is a spontaneous report from a contactable consumer (patient). A 47-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9269) via an unspecified route of administration, administered in left arm on 04Feb2021 10:30 am at a single dose for covid-19 immunisation. Facility where the most recent COVID-19 vaccine was administered was Other. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient medical history and concomitant medications were not reported. Patient previously took BNT162B2 on 12Jan2021 (at 04:30 PM, Right arm, dose 1) for covid-19 immunisation. The patient experienced felling dizzy (dizziness), disoriented, could not finish the drive home due to disorientation (disorientation), emotional (emotional disorder), crying, nausea, tired (fatigue); all on 04Feb2021 11:00 am and Dose 1: 12Jan2021 04:30 PM; dose 2: 04Feb2021 10:30 AM (inappropriate schedule of product administration) on an unspecified date and (off label use) on 04Feb2021 10:30 am. No treatment received for the adverse events (felling dizzy, disoriented, could not finish the drive home due to disorientation, emotional, crying, nausea and tired). All the events were assessed non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of events Dose 1: 12Jan2021 04:30 PM; dose 2: 04Feb2021 10:30 AM (inappropriate schedule of product administration) and (off label use) was unknown and for all events, not recovered.
Shots on 10/10/03, broke out with rash on 10/19/03.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: Unknown. The reporter is the patient. A female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for Covid-19 immunisation; CoviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for Covid-19 immunisation. The patient's relevant medical history included: "I had the Covid back in 2020", start date: 2020 (unspecified if ongoing), notes: I had the Covid back in 2020. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "She already had the vaccine and she got Covid again". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (25May2022) positive, notes: tested yesterday and I had a positive result. Therapeutic measures were taken as a result of drug ineffective, Covid-19. Clinical Course: "She is calling with regards of the Covid where she already had the vaccine and she got Covid again". When clarified the concern, consumer stated, "Yes, I really I did want to know, because it did not say whether it is me. I had the Covid back in 2020. I had very bad. I was on the vent and everything. I got well from it and tested yesterday, and I had a positive result. I am fully vaccinated with booster, and I have an appointment to get the next booster shot next month. I wasn't not sure whether this medication was for somebody like me who is fully vaccinated and already had Covid at one time, severely. So, I don't know whether I am really going to be severe again and I do have underlying conditions. But with me being fully vaccinated and 'boostered' do I need take this medication? Is this medication for someone like me or is it someone who has not been 'boostered' or vaccinated, for them"? No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient received a third  Pfizer vaccine, the third dose was the same manufacturer as the initial 2 dose series and given greater than six months from last dose. The third dose is not approved in the patent's age group.
Itchy welts, urticaria approx 1''x1''adjacent to injection site.
At approximately 1:30 PM patient was administered hepatitis A Dose #1 followed by HPV (GARDASIL 9) Dose #3. Noted patient became pale, complained of dizziness and blurred vision. Assisted to exam table, provided cooling measures, and apple juice, last food intake 10:00 AM today. Vital signs BP: 120/60, Respirations: 18, Pulse: 72, no respiratory or cardiac distress observed. Doctor informed, advised to have patient lay down another 30 minutes. Patient assessed, no further incident noted.
Information has been received from another manufacturer and was assigned manufacturer report # HQWYE501323FEB05. A 4 year old male was vaccinated on 4/3/97 with a first dose of MMR (lot # 620094/1334D). It was noted that  on 4/6/98, the patient was vaccinated with a dose of included varicella virus vaccine live (lot # 625128/0062H). On 2/5/01, the patient experienced a developmental delay. At the time of the report, the outcome was unknown. On 4/11/01, the patient went on to receive a second dose of MMR (lot # 636663/0020L). Developmental delay was considered to be an other important medical event (OMIC). This was originally reported by a consumer. Additional information has been requested.
Pt came in with Grandmother on 11/3/04. States having pain at injection site with redness and warmth. Stated having some itching to site as well. Talked to grandmother via phone. Stated that no redness, still sore at site. Applying cold packs to site and taking Claritin.
Besides being very tired, I woke up to severe tinnitus ringing in my ears.  I thought that it would eventually go away but it hasn't and I wake up to it each morning and it's with me throughout the day.
Vaccine administered for the second dose was Pfizer and not the same vaccine administered for the initial vaccine of Moderna.
Generalized vaccinia with lesions on face, arms, back, and legs S/P vaccination 10 days ago.  Afebrile and otherwise doing well other than itchy skin lesions. Culture sent of one of the arm lesions. Discharge summary from 08/17/05 states sweat and pain.
I missed two months of my period in July and August.  I then got my period in September, but have continued to bleed for more than two weeks.  At this time, I have not seen a doctor because the amount of blood per day has not exceeded that of a normal period although the length of the period is worrisome.  I have never experienced a period of more than five days.  I am supplementing my diet with iron.
Nausea, Metallic taste in mouth, headache, entire arm in pain for 24 hours.  I was better by the following day 3/20.
Chills, fever, body aches, nausea, headache, mind fogginess, light headed, tired, sleepy ( 36 hours) Body aches, nausea, fogginess, light headed, tiredness (2 weeks)
EE tested positive for Covid more than 14 days after receiving second dose after exposure to positive household member. EE has remained asymptomatic.
This spontaneous report as received from a healthcare worker refers to multiple unspecified patients of unknown age and gender. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On an unknown date, the patients were vaccinated with improperly stored M-M-R II (lot#, expiry date, dosing details, anatomical location, were unknown) for prophylaxis. Previous temperature excursion was reported. Data logger was involved. No adverse effects were reported. There were no product quality complaints (PQC) involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1708USA009095.
no adverse event; total of 47 patients that received the vaccines after the use-by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (total of 47 patients that received the vaccines after the use-by date) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7642B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 06-Jul-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 06-Jul-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (total of 47 patients that received the vaccines after the use-by date). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (total of 47 patients that received the vaccines after the use-by date) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (total of 47 patients that received the vaccines after the use-by date).    Patient was over 18 years of age.  No relevant concomitant medications were reported. Staff gave patients vaccines past the use date of 18Jul2023. On 6Jul2023, 6 doses were administered at administration site 2.  No treatment medication reported.   The case corresponds to 42nd out of 47 patients as reported by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-732752 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2023: Follow up received, updated vaccination date and I narrative.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-732752:Master case
Initial healthcare professional report received on 23 Sep 2010: This patient was vaccinated with MENVEO (batch number 04012012) intramuscularly on 15 Sep 2010. It was reported that the patient received MenA lyophilized conjugate component of MENVEO reconstituted with a sterile diluent and did not receive the MenCYW-135 liquid conjugate component of MENVEO. No adverse event was reported. Follow up report received from the health care professional on 13 Oct 2010: The child did not have any medical history of allergies and did not have any other chronic conditions.
1 hr /p vax arrived @ Dr's ofc /w  bilateral red swollen eyes.  Given Tempra drops w/ vac, however has had Tempra since w/ no problem.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-healthcare professional). The reporter is the patient.   A 36-year-old male patient received BNT162b2 (BNT162B2, Solution for injection), on 28Apr2021 as dose 2, single (Batch/Lot number: unknown, Misplaced/discarded, Expiration date: Unknown) at the age of 34 years, in right arm for COVID-19 immunization; COVID-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 16Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown, Misplaced/discarded, Expiration date: Unknown), in right arm for COVID-19 immunization; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown, Expiration date: Unknown) for COVID-19 immunization. The patient's relevant medical history was not reported. There were no concomitant medications. Other medication in 2 weeks included None. The patient had no known allergies. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient had Covid Rebound symptoms which tested negative on 20Jun2022 and positive again on 22Jun2022. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results, notes: Indication: Treatment of COVID-19; (20Jun2022) Negative, notes: tested negative on 20Jun2022; (22Jun2022) Positive, notes: positive again on 22Jun2022. Therapeutic measures were taken as a result of drug ineffective and COVID-19 included Paxlovid from 05Jun2022 to 09Jun2022.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
had a loss of smell, taste; had a loss of smell, taste; had cold; This is a spontaneous report from a contactable male consumer (patient) sponsored program. A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced had a loss of smell, taste and had cold on an unspecified date. The action taken in response to the events for BNT162B2 was not applicable. The outcome of events was unknown  Information on the lot/batch number has been requested.
Sever otalgia, nasal congestion- exam- engorged boggy nasal turbinates. No op/ facial edema or wheezing. Given BENADRYL PRN.
A red circle appeared around the injection site with red welts or bumps and is extremely sore and sensitive and warm to touch and a small bruise in the center.
This case involves a patient (demographics unknown) who was vaccinated with an expired dose of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] (expired product administered). It was unknown if the patient had any medical history, concomitant disease, or risk factor. The patient's medical treatment(s), past vaccination(s), concomitant medications, and family history were not provided. On an unknown date, the patient received a dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE produced by Sanofi Pasteur (suspension for injection, lot number and expiry date were not reported) via unknown route in unknown administration site for prophylactic vaccination. It was a case of actual medication error due to expired vaccine used (latency same day). It was reported "Medical Assistant calling from Health Care Professional (HCP) office to report that an expired dose of Quadracel was administered to a patient." No adverse event was reported. It was unknown if the patient experienced any additional symptoms/events. It was unknown if there were lab data/results available. 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 Directive 2001/83/EC and Module VI. 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. There will be no information available on the batch number for this case.
From 3/22/21 through 3/26/21 (days 2 through 7 after the vaccine), I experienced: 1) my skin felt like it was sunburned, I didn't have redness or a rash 2) I felt extremely cold, had to put on 4-5 layers including a down jacket inside the house, I never ran a fever 3) I had a headache, first on right side, then on upper left, then center of forehand, drinking 90 ounces or more of water a day helped 4) I had hyperosmia, a heightened sense of smell
several pt from site exp various sx including kidney pain, achiness, nausea, vomiting & diarrhea p/vax;
patient reported feeling dizzy and needed to sit on the ground a minute after receiving the shot. patient requested some water, which has been provided to. patient reported with no difficulty breathing. when I was about to take his blood pressure , the patient was gone.
Presents to Er c/o feeling like "I was falling" approx w/in 5 mins after receiving her second covid vaccine. Slight substernal chest tightness w/ feeling like there is a lump in her throat. No sob/tongue swelling/nausea/vomiting or rash reported. Was given benadryl w/ mild relief.
dose 1 was administered 62 days ago without a second dose administered yet; creepy crawly sensation on the face; face ache; nagging "low grade" headache; This spontaneous case was reported by a consumer and describes the occurrence of OFF LABEL USE (dose 1 was administered 62 days ago without a second dose administered yet), FORMICATION (creepy crawly sensation on the face), FACIAL PAIN (face ache) and HEADACHE (nagging "low grade" headache) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced HEADACHE (nagging "low grade" headache). On 24-Feb-2021, the patient experienced FORMICATION (creepy crawly sensation on the face) and FACIAL PAIN (face ache). On 20-Apr-2021, the patient experienced OFF LABEL USE (dose 1 was administered 62 days ago without a second dose administered yet). On 10-Mar-2021, FORMICATION (creepy crawly sensation on the face), FACIAL PAIN (face ache) and HEADACHE (nagging "low grade" headache) had resolved. At the time of the report, OFF LABEL USE (dose 1 was administered 62 days ago without a second dose administered yet) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were reported.  Treatment medication included Advil.
Redness, slight swelling, increased warmth around DTaP site. 4 x 3.5 cm. Not tender.
11 hours after the HPV vaccine was given, started to break out in hives on injection site and torso. Went to emergency room and was treated with Benadryl.
Vaccine administered 8/9. 8/10 pt. developed diarrhea, fever, chills, aches. 8/11 right side of face puffy. 8/12 Difficulty swallowing, feeling something stuck in throat. 8/13 visited primary care Dr. Swelling went down but radiates towards neck and roof of mouth. 8/13 visited Cardiologist - did EKG. Now going to ENT in 2 wks for swelling in throat.
Felt weak, nauseated and dizzy.  Initial bp 96/59; had recipient lay down and wait longer.  bp up after 15 minutes to 107/75
This child had a temp of 104, irregular breathing, cyanosis, twitching, and jerking, this all was observed at home by the parents. The infant was taken to an after hours clinic. Onset of symptoms approximately 1 hour after receiving vaccine. Apnea monitor ordered.
After each vaccine I experienced mild flushing of the chest, neck and face for about 30 min after the vaccine. Once it resolved, they cleared me to go. 12 hours later, I developed a fever of 101, body chills, extreme nausea, diarrhea, headache and other flu-like symptoms which resolved within 2-3 days. I was extremely fatigued and still had body aches for about 5 days after the vaccine. The severity of the side effects were much less with this one compared to the 2nd or 1st dose.
Fever, chills,  extreme body aches, nausea, diarrhea, fatigue over a period of two days.