chrisvoncsefalvay/vaers-outcomes huggingface dataset:
2 weeks after vaccine injection, I started having chest pains, breathing issues, and they continue to this day.  I am unable to be around any type of smoke, or aerosol spray, it caused me to have chest pains, and breathing issues.  Feelings of weakness that come and go, and misc. body aches from time to time.  I have been to my doctor and had an EKG, and a stress test, with blood work, and have been told I'm fine, or its asthma.  Prior to taking the Vaccine I was healthy, and smoke never bothered me.  This has no been gradual but almost an instant affect on my body.
cellulitis @ site of vax 16FEB;lesions 15-17 began eruption 28FEB;
ARM ON PNEUMOVAX SITE WAS RED AND SWOLLEN FROM INJECTION SITE TO WRIST. ADVISED PATIENT TO USE ICE PACK, BENADRYL, AND IBUPROFEN AND CONTACT MD TO ADVISE ON ANY FURTHER TREATMENT.
Patient is a 46 y.o. female with a history of ESRD on Dialysis, GPA,  chronic respiratory failure, admission to hospital (1/11-12/23) for fever, respiratory failure, volume overload as well as AMS, left AMA, repeat ED visit 2/6/23 for nausea/dizzness, left AMA who presented to hospital 2/10/2023 with COVID+, shortness of breath, nausea, generalized pain. CXR with pulmonary venous congestion and R sided Effusion. NT-proBNP of 154k, Troponin 253. CBC with pancytopenia.    1. COVID19 with Chronic Respiratory Failure: reported positive on 2/8/23 at Hospital., with pancytopenia On 6L NC at baseline per patient, continued. On paxlovid PTA. CXR as above.  Goal sp02 88-92%. Initiated steroids (2/10-20/23) given risk factors, will send home with prescription. 2. Elevated Troponin: 253 on admission, repeat of 233, hx of elevated troponin. Possibly Type 2 in the setting of demand, fluid overload, ESRD. EKG with NSR. TTE 1/2023 with EF 50-55%, pHTN. Repeat TTE pending, pt would like to follow up with the results at OP follow up. 3. Acute on Chronic HFrecEF/Pulm HTN: per hx, TTE as noted above. NT-proBNP of 154k, mild fluid overload. Symptoms much improved after Dialysis on 2/10-11.  4. Abdominal Pain: reported acute on chronic, diffuse without guarding. Suspect in the setting of COVID19, however hx of diverticulitis 12/2022. CT A/P 1/2023 at Hospital reported improvement in colitis, abdominal omental nodules. Admit CT A/P showed stable hepatic cyst, CBD measuring 12mm (thought to be dt reservoir following cholecystectomy, small volume ascites. LFTs unremarkable including normal bili. Symptoms much improved after Dialysis on 2/10-11.  5. Epistaxis: in the setting of COVID19, thrombocytopenia, as well as chronic 02. Humidify 02. Resolved in ED.  6. Hypocalcemia: hx of. ical of 3.6, repleted.  7. ESRD On Dialysis: per hx MWF Dialysis in the setting of GPA. Recent Dialysis catheter infection with exchange 10/2022 due to proteus bacteremia. Undergoing transplant evaluation at Hospital. Nephrology followed, Dialysis ran 2/10, 2/11.
When the rib cracked went to doctor. She prescribed pain pills, week later it went popped again. Years went by without problems, breast cancer showed up 2007. Went for chemo-radiation treatment. The rib acted up and has ever since.  4/29/09 Received PCP medical records of 9/2003-3/2009. FINAL DX: Type II DM; HTN; hyperlipidemia; hypothyroidism; right breast ductal carcinoma in situ stage 1; arthropathy Records reveal patient stated in 9/07 breast cancer was very small, surgically removed & no chemo or rad tx needed then started chemo 10/07.
Moderate pain, swelling, at injection site which lead to chills, & SEVERE FATIGUE. Then later on nausea.
Client is a 13 year old male who was scheduled for a Pfizer 12 year old or older Covid-19 vaccine. Client received a Pfizer pediatric (5-11 year old) formulation.  Client's mother denied the client having any adverse symptoms since vaccination.
Soreness of Arm; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Soreness of Arm) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     No medical history information was reported.     On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced INJECTION SITE PAIN (Soreness of Arm). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, INJECTION SITE PAIN (Soreness of Arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 23-Jan-2021 and was forwarded to Moderna on 23-Jan-2021.    This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Soreness of Arm) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     No medical history information was reported.     On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced INJECTION SITE PAIN (Soreness of Arm). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, INJECTION SITE PAIN (Soreness of Arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided.
Tongue swollen to point I couldn't talk.  Swelling reduced after 2 hrs. went away after 8 hrs.
Breakthrough COVID infection. Unable to assess symptoms. Positive COVID test on 5/4/22
severe seasonal allergies have disappeared after receiving my Covid Booster Vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. Relevant medical history included: "seasonal allergies" (unspecified if ongoing), notes: my severe seasonal allergies. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "severe seasonal allergies have disappeared after receiving my Covid Booster Vaccine".  Additional information: Subject: Patient Assistance. Customer Verbatim: Patient just wanted someone to know at Pfizer that patient's severe seasonal allergies had disappeared after receiving patient's COVID Booster Vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pt recv vax & exp itching;reporter noted that pt did not have a rash;no further details were provided;
61 years old patient received a Fluzone High Dose/no AE; 61 years old patient received a Fluzone High Dose/no AE; Initial information was received on 02-Mar-2020 regarding an unsolicited valid non-serious case from a non-health care professional.  This case was linked to cases 2020SA057096 and 2020SA057067 via same reporter.  This case involves a 61 years old patient (unknown gender) who received INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (lot number not reported via an unknown route at an unknown administration site) on an unknown date for prophylactic vaccination(PT: Overdose and Product administered to patient of inappropriate age).  Medical history, concomitant therapy, medical treatment, vaccination and family history were not provided.   It was actual medication error case due to inappropriate age at vaccine administration and overdose.  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 holders 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.  Information on the batch number was requested.
Shingles; This is a spontaneous report from a contactable consumer. This consumer reported similar events for two patients. This is the second of the two reports.  A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) on 16Mar2021 as a single dose, with route of administration unspecified, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 23Mar2021, the patient had shingles. The outcome of the event was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021391085 same reporter/product/events, different patient
Tingling and burning in soles of feet and also partial loss of feeling in both legs.  Tripped  a couple of times due to not fully being able to feel where feet were placed. This went on over the next three days and somewhat lessened after that.  Currently still having some tingling symptoms at night, one month after the shot.
This spontaneous report was received from a licensed vocational nurse and refers to multiple unspecified patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On multiple unspecified dates, the patients were vaccinated with improperly stored doses of PROQUAD (lot # M017334, expiration date: 05-OCT-2017), subcutaneously for prophylaxis. There was no adverse effect reported. Product quality complaint (PQC) was not involved. This is one of two reports received from the same reporter. Albumin status for PROQUAD (lot # M017334, expiration date: 05-OCT-2017) has been verified as recombinant human albumin (rHA). Follow-up information has been received on 13-DEC-2016. All telephone attempts to obtain follow-up information have been unsuccessful. The reporting nurse was unavailable. Additional information has been requested. Sender's Comments: US-009507513-1611USA002917: MERCK 1610USA010725: Mfr number.
I received a Clovis booster, upon injection I tasted the vaccine in my mouth, 2 minutes after my right eye went blurry and felt an odd sensation in the right side of my temple, 1.5 weeks post the booster injection I started to feel muscle twitches all over my body, they felt like small twitches/spasms in all different parts of my body, I started loosing weight and experienced muscle loss and weakness, I reported symptoms to my healthcare provider during a telemedicine visit, the symptoms have diminished but I still feel muscle twitches in different part of my body especially my lower extremities
p/vax pt broke out w/a mild case of chickenpox w/mult papules & some vesicles on trunk, face, groin, & scalp;pt sought unspecified medical attention;
developed runny nose today; feel congested; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (developed runny nose today) and NASAL CONGESTION (feel congested) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Apr-2021, the patient experienced RHINORRHOEA (developed runny nose today) and NASAL CONGESTION (feel congested). At the time of the report, RHINORRHOEA (developed runny nose today) and NASAL CONGESTION (feel congested) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Apr-2021, COVID-19: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient stated that he got the first vaccine on 30-MAR-2021 scheduled for second dose on 27-APR-2021. He teste positive for Covid on 26-Apr-2021. He said that his daughter and son in law tested positive last week and He had exposure through their 6 month old child. he developed runny nose on that day and felt congested but nothing else. no Treatment medications were reported. No Concomitant medications were reported.  Treatment information provided by reporter Benadryl
pt presented to Ed with worsening cough, fever and SOB, sx X 4 days; hypoxic, placed on a non-rebreather; mucoid sputum, tested positive for COVID; pt declined intubation; acute respiratory failure with hypoxia; pt's condition declined and he died in the hospital
Patient fainted after receiving her second dose of Gardisil Vaccine. Patient c/o headache and pain in back of her head. Returned to office 12/28/06 for exam. Still c/o head pain. To call office prn with followup.
Chills, fever, joint pain, severe muscle aches,  headache,  Shaking, fatigue, pounding heart, tongue tingling, roof of mouth very hot, diarrhea, small amount of nausea, Diminished appetite.
Within 24 hrs joint aches - pain level 9. Then progression of irritation at injection site: redness, swelling, warmth to deltoid muscle (remains 1-11-2012). Now joint pain at level 2; continues to take MOTRIN 800 mg.
an infant was administered Quadracel instead of Pentacel with no AE; Initial information regarding this unsolicited valid non-serious case from the via Global Medical Information (GMI) (Reference number- 00418272) was received from nurse and transmitted to Sanofi on 08-Jan-2021.  This case involved a 7 months old male patient who received a 0.5 ml dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] instead of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] (lot: C5755AB, expiration date: 10-Jul-2022), an infant was administered Quadracel instead of Pentacel (Wrong vaccine administered). The dose was given in the right thigh via intramuscular route.  The patient's medical history, medical treatments, vaccinations and family history were not provided.  Concomitant medication included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVENAR 13) for Immunisation; ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for Immunisation; and INFLUENZA VACCINE (INFLUENZA VACCINE).  It was a potential medication error due to wrong vaccine administered (Wrong product administered).  At the time of reporting, the vaccine was administered.  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.
fatigued/tired; could not workout; he was not up to exercising/ He did not have the energy to do it; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 54 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 10Mar2021 11:15 (Lot number: EN6203) at the age of 54 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Irregular Heartbeat" (ongoing), notes: Verbatim: Irregular Heartbeat, A-Fib; "A-Fib" (ongoing), notes: Verbatim: Irregular Heartbeat, A-Fib; "sick", start date: Feb2020, stop date: Feb2020, notes: States he was sick in Feb2020. Concomitant medication(s) included: BYSTOLIC taken for heart rate irregular, atrial fibrillation, start date: 2016 (ongoing). Past drug history included: Metoprolol 100mg, reaction(s): "Irregular Heartbeat"; Metoprolol 100mg, reaction(s): "A-Fib", notes: he was diagnosed about 18 years ago and was on Metoprolol 100mg for about 13 years. Vaccination history included: Flu shot (Caller states that he has gotten the flu shot every year for maybe 28 years.In that time maybe twice he has had chills and a slight fever that lasted about 24 hours.), administration date: Oct2020, reaction(s): "chills", "slight fever".  The following information was reported: FATIGUE (non-serious) with onset 10Mar2021 14:15, outcome "recovered" (15Mar2021), described as "fatigued/tired"; IMPAIRED QUALITY OF LIFE (non-serious) with onset Mar2021, outcome "recovered" (15Mar2021), described as "could not workout"; ASTHENIA (non-serious) with onset Mar2021, outcome "recovered" (15Mar2021), described as "he was not up to exercising/ He did not have the energy to do it".  Additional information: He stated that he got his first shot 2 weeks ago. Is curious to hear about possible side effects of the second vaccine. States he had 3-4 days of fatigue after the first shot. Should he expect the same from the second. Stated he is not hearing too much with the first shot. Says three hours after his vaccine he was tired, slept for a few hours. The next couple of days he was not up to exercising. States he always exercises but did not feel like doing so during that time. He did not have the energy to do it. States that he read that some people who had side effects on the first dose may have had Covid previously. Or may not have the same experience for the second shot. Wanting to know if Pfizer has any information available on that.His second dose is due a week from today and wanted to know about it. Surrounded by elderly people., Has young kids, didn't want kids to get him sick and then he gets it and pass it to someone else. No prior vaccinations (within 4 weeks).  . No follow-up attempts are possible. No further information is expected.
1st vaccine only had a sore arm for a few hours.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 27Mar2021 16:45 (Lot number: EP6955) at the age of 38 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "high blood pressure" (unspecified if ongoing), notes: high blood pressure, factor V leiden, pre-diabetes; "factor V leiden" (unspecified if ongoing), notes: high blood pressure, factor V leiden, pre-diabetes; "pre-diabetes" (unspecified if ongoing), notes: high blood pressure, factor V leiden, pre-diabetes. Concomitant medication(s) included: SPIRONOLACTONE; TRIAMCINOLONE; BIOTIN; TYLENOL. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "recovering", described as "1st vaccine only had a sore arm for a few hours.". Therapeutic measures were not taken as a result of pain in extremity.  No follow-up attempts are possible. No further information is expected.
patient was pregnant with no reported adverse event; Initial information received on 23-Sep-2022 regarding an unsolicited valid non-serious case received from a healthcare professional.  This case involves Adult female patient who was exposed to vaccine Influenza Quadrival A-B Vaccine [Fluzone QIV] in context of patient was pregnant with no reported adverse event.   Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. Event occurred at unknown gestation period<<the gestation period at onset and gestation period at exposure data needs to be populated, if available>>  The date of last menstrual period was reported as 22-Apr-2022. The estimated due date is 23-Jan-2023. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient had unknown previous pregnancies.   On an unknown date, the patient received 1 dosage form (DF); dose number: 1 of suspect Influenza Quadrival A-B Vaccine Suspension for injection (strength, route, frequency: unknown) (lot number: UT7682KA and expiry date: unknown) via unknown route in the left deltoid for Prophylactic vaccination (Immunisation). Date of last injection was 22-Sep-2022.  On an unknown date, the patient developed a non-serious event of, patient was pregnant with no reported adverse event (maternal exposure during pregnancy) (unknown latency).  It is unknown if there were lab data/results available.  Action taken with QUADRIVALENT INFLUENZA VACCINE (FLUZONE QIV) was not applicable.  At time of reporting, the outcome was Unknown.  Additionally, at time of reporting, the pregnancy is still ongoing.
Headache, extreme fatigue, fever, weakness, dizziness, loss of appetite, numbness of face, body aches. Treatment per ED visit- Prednisone 40mg x 4 days, steroid shot, Benadryl 25mg every 6 hours.
Took Tylenol. Felt achy, tired, couldn't move. Headache. Neck and back pain, high blood pressure.
Post vaccine pt became dizzy and lightheaded. Pt transferred to med obs via wc. Pt reports immediately feeling better after sitting down on litter. Vitals obtained and monitored. Pt  had no complaint of chest pain. Pt had no complaint of SOB. Pt released at 14:01. Vitals as follows: 1349 SITTING BP 126/84 HR 70 RR 16 SpO2 98% 1400 STANDING BP 110/76 HR 71 RR 16 SpO2 98%
Development of Shingles after the first dose of Shingrix.; Adverse event; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd October 2019, the patient received the 1st dose of Shingrix. On 6th October 2019, 4 days after receiving Shingrix, the patient experienced shingles and adverse event. On an unknown date, the outcome of the shingles and adverse event were unknown.   It was unknown if the reporter considered the shingles and adverse event to be related to Shingrix.  Additional details were provided as follows: The health care professional reported that, after receiving 1st dose of Shingrix had shingles. The healthcare professional also stated that he reported the adverse event after the patient developed Shingrix. The reporter called to ask whether the patient should receive the 2nd dose of Shingrix or not. The reporter consented to follow up
Patient had symptoms of shingles on 4-13-2019 and Dx confirmed on 4/16/2019.
pt recv vax & 2wk p/vax pt child brought home bad case of chicken pox;3-4 days p/exposure pt devel a mild case of gen chickenpox;
I experienced an early menstrual cycle after the first shot with very light flow. Two weeks after the second shot, I am experiencing very heavy flow compared to normal, and had moderate period cramps on the first day of menstruation. This is atypical as my cycles are usually cramp-free with moderate flow. I also experienced additional fatigue on the first day of my cycle.