chrisvoncsefalvay/vaers-outcomes huggingface dataset:
12 hours after first injection - arm pain, severe headache that lasted multiple days.  15 hours after second injection awoke from sleep severe difficulty breathing, uncontrol able chills, fever, that lasted 2-3 hours. Difficulty breathing continued but was helped by rescue inhaler and regular inhaler (had not used either in over a year . 24 hours later, still having difficulty breathing , headache and severe ringing in both ears, spoke with my primary doctor that informed me these type of reactions are expected and will go away. Suffered daily with these conditions and the following Friday night severe difficulty breathing and went to Emergency room the following morning as Dr and walk in could not see me as I had "Potential Covid 19 condition". Hospital ER conducted a covid test that was negative and gave me a nebulizer treatment and started me on prednisone.
I developed a lump under my left armpit 2 days after my vaccine and my arm was sore. On 2-11, I went to the doctor and his assistant seen me and she felt the lump and scheduled an ultrasound. I had the ultrasound on 2-18 and they saw the lump on the ultrasound and they told me it was most likely due to my vaccine. It is a lot smaller now and does not hurt.
Initially had redness and swelling to vaccine administration in left tricep.  That resolved without incident but patient developed a rash to the left arm 10 days after the administration of the vaccine.  Not certain of time of day.
I had the vaccine on 4/2. On 4/3 I had all the typical symptoms of weakness, chills, headache, nausea, tired, aches in the body, and fever that lasted all day.  It went to 104 and I was sweating down my face without doing any activity.  Around 3 am on 4/4 I was so dizzy and nauseas that I finally was able to vomit and I was able to sleep.  When I woke again the fever was gone.  The headache lasted well into the afternoon, but all other symptoms were gone.
4JUN pt appeared to sleep longer than normal; 5JUN mom noticed blood on baby's nose & found pt not breathing; ambulance was called pt was DOA @  hosp;
190 patients (9 different lot numbers) received a vaccine past the beyond use by date; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond 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)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, 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 an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond use by date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond 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 (190 patients (9 different lot numbers) received a vaccine past the beyond use by date).    This case was created for 132nd patient of the 190 patients involved. Concomitant medication was not provided. It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 Vaccine. Treatment information was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-704335 (Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704335:MASTER CASE
Acthib was administered to patient and sterile diluent was used, no AE; Initial information received on 12-Jun-2020 regarding an unsolicited valid non-serious case received from a consumer/ non health care professional (Office staff).  This case involves patient (unknown demoghraphic) who was vaccinated with HIB (PRP/T) VACCINE [ACT-HIB] (lot number and expiry date: not reported) via an unknown route at an unknown administration site for prophylactic vaccination, on an unknown date.  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medication was not reported.  It was an actual medication error case due to Wrong solution used in drug reconstitution (product preparation issue). It was reported that the Acthib was administered and sterile diluent was used and Sterile Water was used to reconstitute ActHIB and it was administered to a patient.  At the time of report no adverse event was reported.  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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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.
This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose administered to patient/Dose administered more than 12 hours post puncture) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination. No Medical History information was reported. On 20-Jan-2022 at 10:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jan-2022 at 10:00 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose administered to patient/Dose administered more than 12 hours post puncture). On 20-Jan-2022 at 10:00 AM, EXPIRED PRODUCT ADMINISTERED (Expired dose administered to patient/Dose administered more than 12 hours post puncture) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Moderna COVID-19 vaccine was administered 12 to 15 hours beyond the expiration date. Date the vial was initially stored in the refrigerator was on 23 Dec 2021. Concomitant drugs were not reported. Treatment details were not given. Most recent FOLLOW-UP information incorporated above includes: On 26-Jan-2022: Follow-up information received contains reporter details and updated narrative.
Patient related to writer incident of heavy epistaxis after flu shot last year-received vaccine 12/04/2003-now presents with multiple brusing arm (bilateral) and legs and denies other symptoms.
15 year old patient was administered a half dose Moderna booster that is only approved for ages 18 and older. Patient's guardian signed the patient up for Moderna on our pharmacy's appointment system and verbally requested Moderna at the pharmacy window. Patient was previously vaccinated with two Pfizer doses, per patient and guardian. There are no known adverse reactions at this time.
sudden collapse w/cyanosis & shaking & SOB; arrival to ER-pt alert, active, pink; ABG's okay;
INFLAMATION OF THROAT,PAIN INJECTION SITE , HEADACHE,TIRED,MUSCULAR PAIN CHILLS,JOINT PAIN,FEVER,PARNASAL INFLAMATION AND HOARSLY.
Narrative: COVID infection following COVID vaccine series 02/02, Pfizer, dose #1 03/05, Pfizer, dose #2 08/16 COVID swab, result: detected 08/16 SARS-COV-2 LINEAGE AY .4 08/16 SARS-COV-2 CLADE 21A DELTA 08/17 pt cc:no symptoms reported exposure: unknown clinically resolved
vesicular rash; This is a spontaneous report from a contactable nurse (patient). A 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 2 intramuscularly administered in right deltoid on 17May2021 10:00 (lot number: EW0186; Pfizer) (52-year-old at vaccination) as single dose for COVID-19 immunisation. Patient's medical history included myelodysplatic syndrome with 5Q deletum from 04Dec2014 and ongoing (in remission), prothrombin gene mutation from 10Dec2018 and ongoing, thrombocytopenia from 20Aug2004 (controlled values normalized), hypothyroidism from 23Jun2005 to 01Jan2008 (diet controlled), hyperlipidemia from 16Feb2006 and ongoing (on medication). Family medical history relevant to AE(s) included family history of hypercholesterol, thromboembolic disease, cancer of ovary. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 1 intramuscularly, administered in left deltoid on 19Apr2021 at 13:00 (lot number: EW0153) for COVID-19 immunisation and experienced vesicular rash and redness. Prior vaccination included Infs press free adult 4 years (Manufacturer: Seqirus; Batch/ Lot: 290295) intramuscularly in left deltoid (No. of previous doses: 10) on 11Feb2021. Concomitant drugs included Baby aspirin for Prothrombin gene mutation orally from 2010 and ongoing, multivitamin for nutritional support Orally from 2010 and ongoing, paracetamol (TYLENOL) for Pain from vaccine orally from 19Apr2021 to 22Apr2021. Vaccination facility type was hospital/ workplace clinic. The patient was not pregnant. The patient experienced Re-occurance of vesicular rash one day post 2nd covid vaccine (on 18May2021). Seriousness criteria were important medical event. AE Required visit to emergency room (urgent care, physician office. The outcome of event was resolved with sequalae on 28May2021. Treatment received included Clobestasol ointment. The reporter considered the Pfizer product had a causal effect to the adverse event. Relevant tests included varicella zoster virus detection on 25Apr2021 with results: not detected (comments: not detected); wound culture on 25Apr2021 with comments: results not found.
W/in 1/2 hr of receiving vax pt exp lightheadedness, dizziness, sweating & had a BP of 110/60; rxn was felt to be vagal response; Also exp tingling in both arms & hands, tingling of lips, itchy throat, ringing in ears; MD felt neurogenic rx
Moderna Bivalent COVID-19 Vaccine EUA: case resulting in invalid dose given  Patient has previously received Pfizer Bio-NTech Vaccines on 12/23/2020 and 1/8/2021. Patient received Moderna Bivalent vaccine on 3/15/2023 at 15:17PM. Pt inadvertently received vaccine which  expired on 1/22/23 . Error was found while documenting on 3/15/2023. No harm came to patient. Patient has been contacted, is doing well, and will return for revaccination per Moderna and CDC recommendations.
For approximately 72 hours post injection, I had fatigue, nausea, and headache. The nausea and upset stomach have persisted for 9 days.  Headache still a problem.
This case was reported by a pharmacist and described the occurrence of bruise injection site in a 53-year-old female subject who was vaccinated with FLUARIX quadrivalent (GlaxoSmithKline). On 10 December 2013 the subject received 1st dose of FLUARIX quadrivalent (unknown, right arm). On 10 December 2013, less than one day after vaccination with FLUARIX quadrivalent, the subject experienced injection site bleeding. On 11 December 2013, one day after vaccination with FLUARIX quadrivalent, the subject experienced bruise injection site, described as bruising "half-dollar size". At the time of reporting the bruise injection site improved; the injection site bleeding resolved on 10 December 2013. The lot number was reported as "5K4TZ" from the reporter; however, based on a safety lot number review, the lot number was updated to 5K4TL.
Pt states she had pneumonia vac. on 5/25 in her R arm- Pt states that her are started hurting that night. When she woke up her shoulder was the size of a softball and warm to touch. Pt rated pain at 10 on 0-10 scale.
Mis-administration of vaccine where an undertermined amount of vaccine ran down patients arm after administration. Per CDC guidance, a second vaccine was administered by vaccinator in the patient's opposite arm.
eye twitching; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of BLEPHAROSPASM (eye twitching) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BLEPHAROSPASM (eye twitching). At the time of the report, BLEPHAROSPASM (eye twitching) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medications were provided
On 10/31/01 soreness in arm and neck, with pain on movement. Also had swelling. Took Ibuprofen because nauseous. On 11/1 symptoms abating.
1 of 4 pts vaxed from the same DTP lot# exp a fever of 103.5 & an inject site react consisting of swelling & local rash; pt also had an apneic episode & was seen in ER;
Administration error: Kinrix combo vaccine inadvertently given to a 9 year old and age outside of the recommended age group to receive Kindrix/ DTaP.
I started having pain in my left calf on Sunday 4/11/2021. I went to the doctor on the next day, Monday, April 12 at 9am.  He sent me to the center where they did an Ultrasound which was positive . I was adviced to go to the Hospital for a CT  scan of my lungs and brain.  I went to medical center on Monday at 6pm. There I was given an Iodine CT scan.  They noticed a small spot of pneumonia. They repeated the Ultrasound of my leg and took a swab for Covid-19. I was given a prescription for Xarelto and an antibiotic , Levaquin, 500mg.. I came home.
pain so bad after the first Shingrix dose; could not get out of bed for a week; This case was reported by a pharmacist via call center representative and described the occurrence of pain in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain and bedridden. Shingrix was discontinued. On an unknown date, the outcome of the pain was unknown and the outcome of the bedridden was recovered/resolved.   It was unknown if the reporter considered the pain and bedridden to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Patients experienced pain so bad that they could not get out of bed for a week and they declined to receive the second dose. No further details were provided. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020202994:same reporter
Did not see on the Pentacel box that polio was included and gave patient Pentacel (IM) and IPOL (SQ). Spoke with patients Mom the next day and she stated that patient is doing well (usual happy self) and not showing any signs or symptoms that would indicate there is something  wrong.
Fever 103 start 4 hours after vaccine and still persist after 24 hours, rigors, headaches, back pain, left side weakness and numb, severe myalgias, confusion
Information has been received from a registered nurse concerning a 12 month old male with no known medical history or allergies who on 13-Oct-2005 at 5:00 p.m. was vaccinated SC with a dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (+) varicella virus vaccine live (lot #651812/0769R). There was no concomitant medication. Sixteen hours later at 9:00 am on 14-Oct-2005, the patient developed a very faint pink colored rash on the torso only. The patient had no fever, and there was no reaction at the injection site (not specified). Medical attention was sought; no treatment was given. No laboratory diagnostic tests were performed. The patient was recovering. Follow-up information indicated that on 14-OCT-2005 at approximately 9:00 am, the patient developed a fine red rash over his abdomen and back. He subsquently recovered. No further information is available.
At around 7pm I began to feel chills, body aches, no fever, injection arm beginning to hurt. During the night I woke up because my body was shaking from chills even thought I was under my comforter in a warm room. My injection arm was hurting more and my arm pit of the injection arm felt throbbing and painful. In the morning  I still had body aches, temp 99.2, my injection arm and arm pit are painful, my arm pit was swollen. I took 1,000 mg Tylenol.  Now at 03:40pm I still have body aches, arm pit still painful but not as swollen as before, chills less frequent, temp 98.4.
Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 06-Feb-2022; Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 06-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 06-Feb-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 06-Feb-2022) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Feb-2022 at 3:21 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 06-Feb-2022 at 3:21 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 06-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 06-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 06-Feb-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 06-Feb-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product use was reported.   The patient received vaccine past its 30 days expiry date on 06-Feb-2022 at 15:21:39 PM, Booster dose. Vaccine went into 2 to 8 degree Celsius thaw state on about 24-Dec-2021. The vaccine was administered up until its manufacturing expiry date of 04-Apr-2022.  No treatment information was provided.
6 days after shot I started to feel tingling in my face, the arm pain where injection was started to hurt, upper shoulder and neck pain, shooting pains to the head, light headed, throat tightness, chest pains in middle and difficulty breathing and speaking.  Slight chills and happened for 2 days - shoulder and neck pain is still lingering to date. took tylonol, iced all areas and motrin   - and a lot of tears and prayers.
pt recv vax & devel an inj site rxn characterized by a 10-40cm area of redness & pain;pt recovered;this is 1 of 11 pt from this facility to devel an inj site rxn p/flu vax lot# 4978296;
30-year-old female with no prior cardiac history admitted with 3 weeks of shortness of breath.  Symptoms began 2 weeks after receiving second dose of Pfizer Covid vaccination.  During hospitalization, diagnosed with new onset pulmonary hypertension and right-sided heart failure.  Admitted to ICU, and treated with noninvasive positive pressure ventilation, thoracentesis, and intravenous diuretics.
Rash from shoulder to elbow.  It wasn?t itchy or irritated. The rash has reduced. I did not contact my doctor since I didn?t feel it was serious. I wanted to report this possible side effect.
Patient who was 17 years old on the time of vaccination was given a Moderna Covid-19 vaccine even though  it was only indicated for 18 years old and above. No reported adverse reaction was reported by the patient.
Severe tinnitus developed after booster shot. It's been over a month now and my entire nervous system is shot. I can't sleep, loss of appetite, ear pain, anxiety, panic attacks.
On Thursday 5/26, one week after my second booster  I tested positive for Covid.  I most likely was exposed since my daughter in law came down with Covid the next day, Friday 5/27.  We were both eating in a restaurant the Monday before (5/23).  Two other members of our party never came down with Covid. I contacted advice nurse, who schedule a video appointment with my doctor the same day.  I was showing mild symptoms:  congestion, sore throat, fatigue.  My doctor prescribed Paxlovid started the same day.  Tuesday 5/31,  I tested negative and my symptoms were gone.   I tested again on Friday 6/3, tested negative again.
3rd dose early given /no documentation of vaccine given; This case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too short in a 67-year-old female patient who received HBV (Engerix B adult) for prophylaxis.   Previously administered products included Engerix B adult  (received first dose on 26th July 2022) and Engerix B adult (received second dose 26th August 2022).   On 10th January 2023, the patient received the 3rd dose of Engerix B adult. On 10th January 2023, unknown after receiving Engerix B adult, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK receipt date: 31-Jan-2023 Reporter's comment: The nurse reported the patient received dose 3 of Engerix (early dose) but there was no record of it at the health care professional office.  The nurse stated that the nurse who gave the vaccines to the patient no longer works there.  The vaccine log did not have this vaccine logged in for Engerix given on 10th January 2023. Medical information, phone numbr and warm transfer were provided. The reporter consented to follow-up. Additional supportive information: The patient received 3rd dose of Engerix-B adult earlier than the recommended interval, which led to shortening of vaccine schedule.
pt recv vax; became limp, pale, crying more 3 hr p/ vax;
After vaccine 1 on 02/04/2021 I only experienced a sore arm.   After vaccine 2 on 02/26/2021 I experienced soreness almost immediately.  The next morning I had soreness at my ankles and knees.  I also had extreme cold chills and a cough.  I later experienced a fever of 101.8 degrees.  Extreme tiredness.
Chills/ fever of 101 F from 7AM 2/27/2021  -Advil- brought fever down Headache and aches and pains all over - Advil- relieved pain Nausea - went away over time  Arm of injection site very sore All symptoms were gone by 2/28/2021 7 AM
This patient did well as a 2 month old with his vaccines, but at 4 months the patient developed some different symptoms.  For an entire week he cried nearly constantly as if in pain, slept poorly and ate poorly.  He had a documented maximum temperature of 100.5 only, had no vomiting, diarrhea, nor rash.  He was seen by myself on day #4 and other than being fussy, there was nothing on physical exam.  The patient had lost only one ounce at that visit compared to the visit where he received his vaccines.
4 days following dose 1, dizziness similar to orthostatic hypotension began and lasted about 3 weeks. At times it required steadying my self. Most of the time it was mild enough not to require standing still. Follwing dose 2, the dizziness returned and has been persistent for the past five weeks. It is never severe but is definitely persistent, unrelated to activity, amount of sleep, time of day, occasional alcohol use, or diet.