chrisvoncsefalvay/vaers-outcomes huggingface dataset:
ITCHING RASH IN CHEST, UNDER  ARMS, BACK AND SHOULDERS FOR 5  DAYS; STINGING BURNING RASH ON THE CHEST, UNDER THE ARMS, ON THE BACK; RASH AND HIVES ON BACK AND SHOULDERS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient was not pregnant at the time of vaccination, no headache, no tiredness, no coughing, no difficulty breathing. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced itching rash in chest, under arms, back and shoulders for 5 days, stinging burning rash on the chest, under the arms, on the back, and rash and hives on back and shoulders. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride, and calamine/glycerol/zinc oxide. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered with sequelae from itching rash in chest, under arms, back and shoulders for 5 days, stinging burning rash on the chest, under the arms, on the back, and rash and hives on back and shoulders. This report was non-serious.
Within the first eight hours, I felt hyper-energetic, giddy, giggly, and drunk. I had no alcohol! Meanwhile, my sister had the same vaccine at the same time as me (she is 2 years younger), and she had the opposite psychological reaction?weepiness, lack of energy, sadness. These symptoms went away when we went to sleep that night. For the next few days, we had flu-like symptoms (aches, fatigue, intermittent nausea).
When receiving my first Moderna on 02/04/2021 I experienced Afib on 02/17/2021, lasting 18 hours, this was after nearly a year with no Afib.  After my third Moderna on 10/26/2021, I have experienced Afib, lasting from 18-22 hours on 10/28/21, 11/8/21, 11/16/21, 11/26/21.  This was after a year of only one Afib event which was triggered from a medication which was immediately pulled.
Pt had previously received Moderna for his first dose of Covid-19 vaccine. He received Pfizer for his 2nd dose. I was informed that only Pfizer was being administered at the offsite clinic that day but the nurse inadvertently give him Pfizer and indicated she must not have reviewed his vaccination record card during a moment of distraction.  The owner of the clinic called and informed/spoke with Pt. I am not aware of him experiencing adverse events related to this medication error. The nurse indicated she will be more diligent in reviewing the prior vaccination record before administering vaccine moving forward to prevent this from happening again.
chills; soreness at the vaccination site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (soreness at the vaccination site) and CHILLS (chills) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced VACCINATION SITE PAIN (soreness at the vaccination site). On 22-Feb-2021, the patient experienced CHILLS (chills). On 27-Jan-2021, VACCINATION SITE PAIN (soreness at the vaccination site) had resolved. On 24-Feb-2021, CHILLS (chills) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant and treatment information were not provided.   This case was linked to MOD-2021-021553 (Patient Link).
BLOOD CLOTS; This spontaneous report received from a consumer (patient's niece) concerned a male of unspecified age, race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown and expiry: unknown) dose, therapy start date were not reported, 1 total for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On JUL-2021 (two months prior), the patient experienced blood clots and died. It was unspecified if an autopsy was performed. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0.20210951234-Covid-19 vaccine ad26.cov2.s -Blood clot. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: BLOOD CLOTS
Pt recvd 2 doses of Engerix-B & devel flu-like sx following 1st dose diarrhea began in 3-4 days & vomiting, muscle aches & joint aches p/4 days; no tx was given; however, pt called in sick; there are no lingering effects;
Acute hip joint pain began on date noted, 3+ weeks after vaccine, gradually appearing in multiple joints, especially shoulders and wrists, accompanied by slight fever, headaches, vertigo. Initially diagnosed as polymyalgia rheumatica with possible giant cell arteritis, but soon mostly ruled out due to limited response to high dose prednisone, which lessened the symptoms  a little.  Extensive testing has since failed to pinpoint the cause. A neighbor in my small, close-knit community developed almost identical symptoms starting the day after he received his 3rd vaccine dose. His doctors have also failed to pinpoint the cause.
A non-serious spontaneous report of inadvertently administered expired FLUMIST was received from a health professional concerning a 11-year-old male patient. Neither relevant medical history nor concomitant medications have been reported for this patient. The vaccine expired on 15-Dec-2010. The patient received the expired FLUMIST on 21-Dec-2010. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
Chills, weakness, shortness of breath, high heart rate (even though the pacemaker controls the heart) headache.  I can't climb stairs without having trouble breathing. I feel like I have the flu. The spot where I got the shot stayed red and hot until this morning and was almost down to my elbow.
All documented with doctor along with pictures and timeline. 9/17 5:15pm Shot taken - initial injection felt a little tingly/itchy sensation within a couple mins of injection (thought it could possibly be the bandaid since it was a rougher bandaid that can sometimes irritate my skin), 9/17 around 8:30pm noticed my arm started a rash at injection site, red bump, still itchiness. Provider believes injection site allergic reaction non-life threatening; 9/17 2:15am continued red rash down my upper arm and darker red circle appeared at injection site, 9/18 12:36pm arm swollen, big red quartersize circle at injection site and small rash underneath stayed same during day along with sore arm, by 9/19 12:12pm Silver dollar size swollen red dot, itchy, sore arm, 9/20-9/21 remained same symptoms as 9/19, on 9/22-9/23 red dot size and swelling started to decrease leaving small quarter size reaction that was decreasing. On 9/24 a week exactly after provider believes covid arm started; 9/24 7:58pm rash came back, skin puffed up making a large silver dollar red mark and skin pain. 9/25 2:15am progressed to a large circle (bottom of a cup size), extremely itchy, very bad swelling with raised bump, hot to touch, 9/25 11:29am same as earlier 9/25 symptoms but swelling started to extend to side of arm, 9/25 12:58pm continued same symptoms but felt increased tension and limited movement in arm due to severe swelling in upper arm at injection site, 9/26 1:33 am continued large coffee cup circle size with swelling spread at injection side  with pain and itchiness, 9/27 12:10 am swelling starts to go down, continued rash but now extreme nerve pain from elbow to wrist feeling like dull nerve pain where it was hard to use fingers like carpel tunnel feeling and extreme pain at elbow, 9/27 7:28pm circle gone down to quarter size - nerve pain continued in arm - headache all day, 9/28-9/29 continued red small circle quarter size, itchy nerve pain started to subside and itchiness as well first days of showing improvement.
Information has been received from a physician concerning a 49 year old female patient with a medical history of hepatitis B who on 05-OCT-2010 was vaccinated with a dose of PNEUMOVAX 23 (Lot#664476/1190Y) (Exp. Date: Unspecified), IM in the right arm. Concomitant therapy included Flu vaccine (unspecified) and ADACEL (administered during the same time; arm not specified). It was reported that the next day, on 06-OCT-2010, patient had had a red swelling in her arm that had been as big as her hand, and had a hard bump in the area of injection. It was also reported that the patient could not elevate her arm after receiving a dose of PNEUMOVAX 23 (Lot#664476/1190Y), IM. At the time of the report the patient was recovering. Follow up information has been received from the physician concerning the 49 year old patient with hepatitis B acute, who on 05-OCT-2010 at approximately 9:30 am was vaccinated intramuscularly into the right deltoid with a dose of PNEUMOVAX 23 (Lot#664476/1190Y). On the same day, the patient was vaccinated with a dose of FLUZONE (Lot # U3639DA) and ADACEL (Lot# C3491AA) both given intramuscularly into the left deltoid). On 06-OCT-2010 the patient experienced site red, hot swollen about as big as her hand, hard bump at injection site and a very sore arm, all on right arm. The patient was treated with ice and ibuprofen. On approximately 07-OCT-2010, the patient had recovered. The patient did not seek medical attention. This is one of several reports received from the same source. Additional information is not expected.
Patient stated that the injection went into the deltoid and not the muscle. Patient stated immediate pain after recieving injection. Pt stated she went to  doctor and  has tendonitis due to vaccine technique and is going to physical therapy
Patient presented to Coast Guard Health clinic 12 days after receiving smallpox vaccine with c/o chest pain.  Pain was reproducible upon palpation.  No friction rub or gallop on cardiac exam.  Patient was afebrils and otherwise had no significant complaints.  Cardiac enzymes were sent and the patient was discharged on NSAIDS for presumed costochondritis.  The chest pain resolved after treatment with NSAID.  The cardiac enzymes subsequently came back elevated.  Patient was referred to the ER where repeat cardiac enzymes were also elevated.  EKG was normal.  Echo was normal.  He was admitted for overnight observation.  The following day a stress test was done and that was also normal.  The patient was dicharged later that day in good condition.
CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a other company (Pfizer, Inc.) concerned a 44 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: ulcerative colitis (on Entyvio infusion), and allergy (Unspecified). The patient received covid-19 vaccine ad26.cov2.s (Dose number in series: 1) (suspension for injection, route of admin not reported, batch number: Unknown and expiry: Unknown) dose was not reported, 1 in total, dose 1 administered in right arm on 15-FEB-2022 10:30 for covid-19 prophylaxis. The batch number was not reported and has been requested. Age at time of vaccination 44 years old. The patient received non-company suspect booster vaccine elasomeran (Moderna covid-19 vaccine) (Dose number in series: 2) (form of admin, route of admin were not reported, batch number: Unknown and expiry: Unknown) dose was not reported, dose 2 administered on 2022 (date and month unspecified) for covid-19 prophylaxis. Concomitant medications included vedolizumab for ulcerative colitis, butalbital/caffeine/paracetamol, and trazodone. On 2022 (Date and month unspecified), the patient had covid-19 (Dose number in series: 2). The patient received non-company suspect drug Paxlovid (form of admin, route of admin were not reported, batch number: Unknown and expiry: Unknown) dose was not reported, from 16-AUG-2022 to 21-AUG-2022 for treatment of COVID-19. On 21-AUG-2022 14:30 (afternoon) following 5 days of treatment with Paxlovid, the patient still tested positive which was confirmed covid-19 infection (Dose number in series: 2) and had confirmed clinical vaccination failure (Dose number in series: 1). Laboratory data included: COVID-19 virus test Positive. The action taken with covid-19 vaccine ad26.cov2.s and elasomeran (Moderna covid-19 vaccine)was not applicable, and treatment discontinued with Paxlovid. The patient had not recovered from confirmed covid-19 infection, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000249240.; Sender's Comments: V0: 20220904514-covid-19 vaccine ad26.cov2.s -confirmed clinical vaccination failure. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Patient was administered a Pfizer Bivalent booster instead of the monovalent primary dose for his second dose.
administration of Pentacel to a patient with only the liquid part containing the DTaP-IPV component, leaving the Hib component, with no reported adverse event; Initial information was received on 10-Aug-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 1 years old male patient who had administration of diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)] with only the liquid part containing the dtap-ipv component, leaving the hib component, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included pneumococcal vaccine CONJ 7V (CRM197) (PREVNAR) for Prophylactic vaccination.  On 05-Aug-2023, the patient received a 0.5 ml, once dose of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine (Suspension for injection) (lot: UJ868AA, expiry date: 30-Mar-2024, strength: standard) via intramuscular route in the left deltoid for Immunisation.  On 05-Aug-2023 the patient had administration of pentacel to a patient with only the liquid part containing the dtap-ipv component, leaving the hib component, with no reported adverse event (single component of a two-component product administered) (Latency: same day) following the administration of diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)]  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.  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.
Drug Exposure During Pregnancy; patient received Arexvy by mistake yesterday; 32 years patient received Arexvy; This non-serious prospective pregnancy case was reported by a pharmacist via call center representative and described the occurrence of wrong vaccine administered in a 32-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number mr5hx, expiry date 01-FEB-2025) for prophylaxis.   On 12-OCT-2023, the patient received Arexvy (intramuscular, right deltoid). On 12-OCT-2023, an unknown time after receiving Arexvy, the patient experienced wrong vaccine administered (Verbatim: patient received Arexvy by mistake yesterday) and inappropriate age at vaccine administration (Verbatim: 32 years patient received Arexvy). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: Drug Exposure During Pregnancy).  The outcome of the wrong vaccine administered, inappropriate age at vaccine administration and vaccine exposure during pregnancy were unknown.   Pregnancy exposure: Pregnancy Exposure (Arexvy): To mother in third trimester  Pregnancy Details (Neonate 1):  Pregnancy Outcome: Pregnancy was ongoing Delivery Notes: 34.5 week pregnant   Additional Information: GSK Receipt Date: 13-OCT-2023 The reporter stated that a 34.5-week pregnant patient received Arexvy by mistake yesterday. She was supposed to receive Abrysvo, which led to wrong vaccine administered. The reporter did not have due date available to share. The reporter consented to follow up. The patient below recommended age received Arexvy, which led to inappropriate age at vaccine administration.
moderna booster dose only vaccine vial used. pt only received 0.25ml instead of 0.5ml (under dosed) today
Left sore arm, achy; itchy left arm; This case was reported by a nurse via sales rep and described the occurrence of pain in arm in a female patient 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 in arm and itchy upper limbs. On an unknown date, the outcome of the pain in arm and itchy upper limbs were recovering/resolving.   It was unknown if the reporter considered the pain in arm and itchy upper limbs to be related to Shingrix.     Additional Information: GSK Receipt Date: 31-Jan-2023 Reporter's Comments: The patient's left arm was sore and achy and itching as it was healing the following day. The reporter did not consent to follow up.
I experienced fever and severe body aches and couldn't stand on my feet which lasted approximately 55 minutes (considered calling the Paramedics but was able to take some Ibuprofen which helped the pain subside. By the time I notified the Nurse at my doctor's office, the pain had subsided (also indicated that the pain was associated with my Fibromyalgia). I still have muscle pain and my symptoms are worst after receiving the vaccine. I lost my smell and taste along an ammonia or silver smell that has been really bad for a week now. I saw my doctor and some tests were order since there is inflammation around my heart and I don't know if it was caused by the vaccines and am awaiting to see a Cardiologist.
Information has been received from a physician concerning his daughter who was vaccinated with Gardasil and fainted. Subsequently, the patient recovered from fainting. Additional information has been requested.
Soreness of the right arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness of the right arm) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018B21A and 018B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included RALOXIFENE, CLOMIPRAMINE, MAGNESIUM, LOSARTAN, ATORVASTATIN, METOPROLOL SUCCINATE, METRONIDAZOLE and KETOCONAZOLE for an unknown indication.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Apr-2021, the patient experienced PAIN IN EXTREMITY (Soreness of the right arm). The patient was treated with PARACETAMOL (TYLENOL) for Symptomatic treatment, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Soreness of the right arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient received both scheduled doses of mRNA-1273 prior to the events therefore, action taken with the drug in response to the events was not applicable. The patient called with a concern whether taking paracetamol couple of hours after the second dose reduce the effect of the vaccine and also reported soreness of the right arm. The first dose was received on the left arm and the second dose was received on the right arm.
pt states around 6 pm on 3/28/21 she developed a stomachache.  This lasted until 4/2/2021.  She developed a migraine headache on 3/29/21 which continued to get worse.  She then started getting dizzy along with a feeling of pins and needles on her head and her feet became numb. She reached out to her Neurologist and she was prescribed chlorpromazine.  After taking one dose it caused her heart to race. She was also prescribed duloxetine by her PCP.  After one dose her blood pressure went up.  BP was 163/110.   On 4/11/21 she went to the ER.  They did blood test (platelets were 154) and CT that was normal.  She was given dexamethasone steroid which helped w/ the heart rate.  She was released to go home.  Her headache came back the same day.  On 4/26/21 she woke shaking and her heart was pounding out of her chest.  Her rate was 169.  She went back to the Medical ER.  Her heart rate was 180.  They did EKG.  She started shaking more, her feet were tingling and going numb, she had a vibration in her head and heat from her neck going up to her head.  Her heart rate was going up to 200.  She felt like she was going to die.  She laid down and her heart rate would go up and down.  They gave her an IV and sent her for an MRI.  She was admitted.  She was getting ready to have an ECHO she had a vibrating and burning sensation go through her body from her neck to head, back down to the left arm and then down to leg and feet.  Her heart rate went up.  This episode lasted about 15 minutes. After getting the MRI she had another shaking and vibrating episode that lasted about 10 minutes.  She had an ECHO and then had another shaking vibrating episode that lasted about 5 minutes.  She was given a beta blocker metoprolol.  All test were negative or normal.  She stayed in hospital to 2 to 3 days and released to FU w/ multiple doctors including psychiatrist, cardiologist and PCP.  She was diagnosed w/ having general anxiety and panic attacks.  She saw her PCP and she was taken off metoprolol to propranolol.  Pt saw a Cardiologist on 5/14/21.  They did an EKG and she was given a heart monitor to wear for 3 days resulting in tachycardia 166 episodes. Overall heart 80 bpm to 119 bpm.  Total beat count 340,832.  Pt still has dizziness and migraine headaches. Her heart is now enlarged and has pain on her left side under her breast and on top of her breast.  She has  these episodes daily and feels like she is still going to die.  She said she never had anything like this before getting vaccinated.   Her Cardiologist is sending her for more tests.