chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Verified pt by name/DOB. Patient was administered a Pfizer Orange Pedi( 5-11 yrs) vaccine IM in left arm. After the vaccine was administered the nurse was unable to document the correct vaccine lot number. The nurse called supervisor to discuss why lot number was not in the system. Nurse was told the lot number was from an expired vaccine. The nurse looked at the label on the vial which had a expiration date of 12/6/2022 and inventory dispersion paperwork with the exact lot number with expiration date of 12/6/2022, which all came from immunization clerk from main office. Nurse was told vaccine was mislabeled. Nurse supervisor contacted Pfizer and medical director for direction and treatment of patient. After speaking with Pfizer and medical director it was determined patient needed to return for another covid vaccine injection as soon as possible. Parents were contacted and brought patient  into clinic the same day for another covid vaccine without any complications or adverse reactions
expired dose administered; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 1-year-old male patient who received DTPa (Infanrix) (batch number 7KM94, expiry date 10-JUN-2023) for prophylaxis.   On 28-JUN-2023, the patient received Infanrix. On 28-JUN-2023, an unknown time after receiving Infanrix, the patient experienced expired vaccine used (Verbatim: expired dose 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: 29-JUN-2023. A nurse reported that a patient received an expired dose of Infanrix.  The vaccine expired on 10 June 2023 which led to expired vaccine used. The healthcare professional consented to follow up via email.
Pt developed chest pain ~7 days after vaccine with elevated troponins (10.2) concerning for myocarditis. Chest pain resolved with still elevated troponins.
Information has been received from a physician referring to a 16 year old female patient. The patient's pertinent medical history, drug reactions/allergies and concomitant medication were unknown. On 31-AUG-2016, the patient was vaccinated with GARDASIL 9 (dose, route, lot # and expiration date were unknown). The patient then informed the staff on 13-SEP-2016 that she tested positive for pregnancy. The last menstrual period (LMP) and estimated date of delivery (EDD) were not known. The pregnancy outcome was pending. No adverse effects were reported. The outcome of the events was unknown. Additional information has been requested.
pt recvd vax & lt clinic w/no problems; returned to clinic @ 12noon w/head to toe urticaria, coughing & hypotensive; responded to Epi; discharged 1 hr later, rx DPH;
cellulitis; redness from shoulder to elbow- left arm; redness at the injection site - left arm; swollen at the injection site - left arm; A spontaneous report was received from a consumer (patient's wife) and concerning a 72-year old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced cellulitis, redness at the injection site - left arm, redness from shoulder to elbow- left arm, swollen at the injection site - left arm.  The patient's medical history includes lung disease. No concomitant medications were reported.  On 14-Jan-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) through unknown route in the left arm for prophylaxis of COVID-19 infection.   On 21-Jan-2021, that is a week later after receiving first dose of vaccination patient experienced a redness at the injection site, which kept traveling, and now is past his elbow. It ranges from shoulder to elbow. She reports it was swollen in the beginning and the redness is now fading. He used topical hydrocortisone cream as advised by a pharmacist. The reporter had called the patient's doctor and the nurse told her that it is likely cellulitis that he picked up during injection. The adverse event of cellulitis was assessed as medically significant.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event cellulitis, swollen at the injection site - left arm was unknown. The outcome of the event redness at the injection site - left arm, redness from shoulder to elbow- left arm was recovering.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-024815:Case for patient
Was in extreme body aches and my pain injection for my sciatica quit working. Could not do anything was in bed that night starting at 6pm then all day the following day I could barely walk my whole entire body hurt as if I was in a terrible car accident. My sciatica was at a ten and to this day I have no relief from my injection when it comes to sciatic pain where before my second injection I was getting relief
dizziness, lightheadedness, fatigue lasting over 24 hours; arm soreness at injection site
Progress Notes    2/24/2021    Patient:                                                                       Date:  2/24/2021                                                                                               Subjective  is a 32 y.o. male who was seen at  COVID Vaccine Clinic today for his first  dose of the COVID 19 vaccination.    He was given the Pfizer vaccination in the right deltoid muscle.   During his 15 minute waiting period after the injection, the patient began to experience lightheadedness, nausea and headache.  He denied difficulty breathing, difficulty swallowing, wheezing and throat tightness. He ate breakfast this morning and was feeling well prior to having his vaccine.    This provider was notified of patient reaction and he was then assessed in the emergency bay area.   Monitored patient for severe reaction symptoms, including but not limited to rapid progression of symptoms, respiratory distress and vomiting.     ALLERGY REVIEW OF SYSTEMS:  Patient complains of dizziness and headaches   Patient denies chills, facial swelling, cough, chest tightness, shortness of breath, wheezing, vomiting and abdominal pain    +Nausea:     Previous Reactions: Denies    Objective    Vitals Vitals:   02/24/21 1126 02/24/21 1222 BP: (!) 144/85 122/64 Pulse: 62 67 SpO2: 98% 100%      Physical Exam Constitutional:      Appearance: Normal appearance.  HENT:     Head: Normocephalic.     Mouth/Throat:     Mouth: Mucous membranes are moist.     Pharynx: Oropharynx is clear. No posterior oropharyngeal erythema.     Comments: No swelling or lips or tongue.  Cardiovascular:     Rate and Rhythm: Normal rate and regular rhythm.  Pulmonary:     Effort: Pulmonary effort is normal. No respiratory distress.     Breath sounds: Normal breath sounds. No wheezing or rales.  Skin:    General: Skin is warm and dry.  Neurological:     General: No focal deficit present.     Mental Status: He is alert and oriented to person, place, and time.        Assessment/Plan  Treatment included: water and Pepcid Follow up response to treatment: good. Sx resolved prior to discharge. Patient discharge: Stable to go home and follow up with PCP.
On 03/18, I started experiencing burning on my tongue. My tongue became swollen and more irritated throughout the day. This progressed in to 03/19, when my throat became sore and swollen as well. I felt like I do when I have strep throat with the amount of irritation in my  throat and tongue. By the evening of 03/19, my tongue was so swollen it was hard to talk and articulate sounds. It was difficult to swallow liquids and I started to get scared. I took a Benedryl and went to sleep. The irritation and swelling eased Saturday and by Sunday afternoon, it was like nothing happened. I went to my general practitioner who sent me to an allergist and everyone agrees it sounds like an anaphylactic response to the vaccine, though unusual in the timing. I still have some burning and irritation on my tongue. My allergist is doing testing and ordered me an Epi-Pen.
bradycardia was not attributable to these shots; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 immunization; Bnt162b2 (DOSE 2, SINGLE), for Covid-19 immunization; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for Covid-19 immunization.The following information was reported: BRADYCARDIA (medically significant), outcome "unknown", described as "bradycardia was not attributable to these shots". Clinical information: There is and has almost always been concerns about the safety and effectiveness of Covid 19 vaccinations. Just for my own peace of mind, can I assume that all covid vaccinations have been thoroughly tested peer reviewed subjected to clinical trials and found safe and effective. I have had four shots now and waiting for a fifth and wanted to make sure bradycardia was not attributable to these shots.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
COVID breakthrough, back pain, muscle aches, slight cough, headache, swollen lymph nods, exhaustion fatigue, migraines and slight fever and shivers.
Very painful back muscle pain and pain on the left side of of my left breast . I used a heating pad for pain and went to the doctor for muscle relaxers and Prednisone. As of today 4/1/2021 I still have pain in the left breast area and the back pain is almost gone.
7pm night of shot and has not gone away Muscle spasms and twitching Elevated heart rate
her knee cap was numb; This is a spontaneous report from a contactable consumer. A 58-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- unknown) via an unspecified route of administration on 31Mar2021 as dose 1 single (at the age of 58-year-old) for COVID-19 immunization. Medical history and concomitant medications were not reported. Caller stated her grandma received the first dose of the Pfizer COVID vaccine today. Patient had side effects to include her knee cap was numb on 31Mar2021. Caller would like to know if she can use ibuprofen on it. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Parent called 4/21/2005 to report adverse event. Pt complained to parents about itching arm, right deltoid on 4/17/2005. Mom observed hives around the injection site, hard lump and raised red area about 2 inches in diameter. Itching started about 4/12/2005 however. Went to MD on 4/18/2005 who instructed parent to continue with topical Benadryl and take oral Benadryl for three days.
Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 16 Feb 2022; Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 16 Feb 2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 16 Feb 2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 16 Feb 2022) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     It was unknown whether the patient had any chronic or long standing health condition. Acute illness at the time of vaccination and upto 1 month before was unknown.     On 16-Feb-2022 at 10:48 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 16-Feb-2022 at 10:48 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 16 Feb 2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 16 Feb 2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 16 Feb 2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 16 Feb 2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient ethnicity was reported as private.  No concomitant medications were reported. No treatment details were reported.
1.6.2021 AT 945 PATIENT REPORTED "FEELING HOT" AND "TONGUE TINGLING"  PATIENT REFUSED EPINEPHRINE AND BENADRYL. PATIENT ACCEPTED ICE PACKS AND WAS TAKEN TO MEDICAL CENTER BY EMS.
Severe fatigue lasting approx 12 hours. If I sat down I felt like falling asleep. I left work early and rested
Infanrix was administered instead of Boostrix; 11 year old that time received Infanrix vaccine; Infanrix was the 6th Dtap dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 11-year-old male patient who received DTPa (Infanrix) (batch number XG942, expiry date 22-AUG-2022) for prophylaxis.   On 18-FEB-2022, the patient received the 6th dose of Infanrix. On 18-FEB-2022, an unknown time after receiving Infanrix, the patient experienced wrong vaccine administered (Verbatim: Infanrix was administered instead of Boostrix), inappropriate age at vaccine administration (Verbatim: 11 year old that time received Infanrix vaccine) and extra dose administered (Verbatim: Infanrix was the 6th Dtap dose). The outcome of the wrong vaccine administered, inappropriate age at vaccine administration and extra dose 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 Information: GSK Receipt Date: 21-SEP-2023 The reporter reported that the 11 years old patient received Infanrix vaccine instead of Boostrix vaccine, which led to wrong vaccine administered and inappropriate age at vaccine administration. The reporter stated that the Infanrix was the 6th Dtap dose, which led to extra dose administered. The reporter consented to follow up.
Warm touch at the injection site; Itchy at the injection site; Red knot at the site of injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Warm touch at the injection site), VACCINATION SITE PRURITUS (Itchy at the injection site) and VACCINATION SITE INDURATION (Red knot at the site of injection) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Warm touch at the injection site), VACCINATION SITE PRURITUS (Itchy at the injection site) and VACCINATION SITE INDURATION (Red knot at the site of injection). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL ITCH) ongoing since an unknown date at an unspecified dose and frequency. In January 2021, VACCINATION SITE INDURATION (Red knot at the site of injection) was resolving. At the time of the report, VACCINATION SITE WARMTH (Warm touch at the injection site) and VACCINATION SITE PRURITUS (Itchy at the injection site) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication details were not reported by the reporter. Treatment included topical steroid cream.
Information has been received from a physician concerning a patient who on an unspecified date was vaccinated with a dose of GARDASIL vaccine (yeast) (lot number not provided) and fainted. The patient outcome was unknown. This is one of the several reports received from the same source. Additional information has been requested.
Swelling on top of left leg, about 3" wide and 4-1/2" long from top of injection site. Site is red, slightly raised, tender to touch.  Thought it was sunburn. Child had been outside all day in sun and swimming. Father denies fever, N/V, SOB, rash, and any other hives anywhere on body. Child is acting "normal/wild as usual". Has not seen healthcare provider. Intends to use cold compresses and advised to watch and if conditions or symptoms listed above occur or worsen, to seek prompt medical attention.  Father verbalized understanding, and was "relieved" to hear information.
pt states after getting her 4th vaccination she woke up early in the morning with a severe headache that went down her spine along with a high temp.  She was worried she was going to have a stroke.  She took a Tylenol for this pain. The headache and temperature subsided after taking the Tylenol but she still was extremely weak.  She was able to take care of herself but could not do anything other than that due to being so weak.  She had some brain fog.  She continued to have mini headaches that would come and go.  She was able to eat some light food and drink fluids. She continued to take Tylenol.  She contacted her PCP to report her symptoms. These symptoms lasted about 5 days.
Severe nausea and vomiting (6-7 episodes of vomiting), fever and chills (temperature to 95.2), diaphoresis, pallor, 4-5 episoes of profuse watery diarrhea, malaise, light-headedness, pre-syncope.
The mom put a false birthday and stated that the child was 12.  He will be 12 on 6/1/2021.
Patient complained of a rush of feeling very hot.   Patient was offered an ice pack for the back of her neck and was monitored until she felt better. Returned home following observation period.
Within the hour the vaccine was administered patient reported signs of lightheadedness, weakness doctor called to report.
No additional adverse events reported; improperly stored vaccines may have been administered to patients; This spontaneous report has been received from a nurse, referring to patient of unknown gender and age. Information about the patient's pertinent medical history, concurrent conditions, and previous drugs reactions or allergies were not provided.  On 27-DEC-2019, the patient was vaccinated with an improperly stored (product storage error) hepatitis a vaccine, inactivated (VAQTA), (Therapy type: Digital Data Logger), lot number S002506 and expiration date 04-APR-2020 for prophylaxis (strength, dose, dose number, frequency, route of administration, and anatomical location, were not provided).  The vaccine was stored at a temperature above 47 degree Fahrenheit (47.1 Fahrenheit), for a timeframe of 8 to 16 minutes, with no previous temperature excursion. The call was due to a Digital Data Logger.  No additional adverse events were reported.  This case is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2001USA009007:
A report was received from a health care professional on 10/29/03 concerning a 2 year old female vaccinee who inadvertently received Fluvirin on 10/29/03. At the time of the report no adverse effects occurred. There was insufficient information to determine the reporter's causality assessment. Update 1, 12/10/03: Follow up information received from a health care professional indicated that the vaccinee did not experience any adverse reaction.
On 11/3/17, he received his first dose of MCV4 at age 13.  On 11/12/17 (9 days later), he developed severe myalgia and arthralgia.  No rash.  On 11/13/17 he developed fever to 103 and severe sore throat.  Throat culture for GAS was negative.  On 11/14/17 he developed substernal chest pain (8/10).  It was worse lying down, better sitting up and leaning forward.  Those symptoms persisted and he was seen, EKG was ?consistent with pericarditis? (I do not have the actual read) and he was admitted to the ICU.  Troponin was slightly elevated.  ECHO showed only a very small pericardial effusion.  CRP was very high.  No ferritin obtained.  He was hospitalized from 11/18/17 to 11/24/17, diagnosed with acute pericarditis (which may or may not have been accurate), treated with ibuprofen and colchicine and discharged, with no recurrence of his symptoms until 4 years later (see below). About 4 years later, on 8/5/21, he received his second dose of MCV4. On 8/14/21 (9 days later), he developed fever to 102, severe sore throat, muscle aches, loss of appetite, and vomiting. The next day he had severe substernal chest pain which was worse when lying down and better when he sat up and leaned forward. This pain was very similar to the pain he felt 4 years ago when he was diagnosed with pericarditis. He was seen and tested for strep and that was negative.  He was seen on 11/18/21 in an ED, EKG was read as ?consistent with pericarditis.?  He was admitted here on 9/1/21 when his symptoms persisted. Our cardiologist read the EKG from 8/18/21 as NL.  His EKG here on 9/1/21 was also NL.  He had a NL ECHO here as well.  5 days prior to admission here, his fevers resolved (after he had been febrile for 10 days) and he developed a maculopapular rash, confluent in some areas, particularly over his joints.  His joints were extremely tender but no joint swelling (i.e., no arthritis).  He had bilateral conjunctival injection.  His CRP was again very high.  Ferritin was 13,000.  CBC was normal except for a leukocytosis with left shift.  No cytopenias.  NL TG and fibrinogen.  Troponin minimally above the normal range. Infectious diseases workup was negative.  Rheumatology recommended high dose steroids despite no diagnosis.  After one dose of IV methylprednisone, his sore throat was better, rash started to resolve, arthralgia disappeared, and conjunctival injection cleared.  His ferritin went from 13,000 to 9000 in 2 days and he was discharged on a tapering dose of oral prednisone.  In follow up in clinic 5 days later, he was afebrile and without arthralgia or sore throat; no rash and no conjunctival injection.  Repeat CRP was normal and ferritin was much better at 2000.  Complement (C3 and C4) were low during his illness (consumption) but normal 5 days after discharge.
1 1/2 later after shot, he started feeling cold, weak, vomited 1 time, chills, lasted 1-2 days.
Unable to lift arm 5 hours after vaccination, took NSAID and symptoms improved the next day, still having some decreased range of motion, she is unable to lift her left hand to her face without pain. TM denies any rashes, numbness or tingling to her left upper extremity.  Will follow up with Occupational Health.