chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Post vaccine I was very tired. Extremely sore arm and arm was I Uaa able for weeks. High blood pressure and remain to have high blood pressure. Heart palputations for several days. Unable to breath for instances from day 1 to day three after vaccination. Admitted to ER on 10/7/2021 with inability to breath, racing heart rate, irregular heart rate and thumping heart beats. Test results revealed high d-diner but CAT Scan did not reveal any blood clots. Went home and continue to have heart stress pains that radiate up from the chest to the right side of my neck, to the right side of my shoulder and down from the right side of my abdomen down from the chest. Two weeks after vaccination the lower part of my right leg is going numb from the knee down including my foot. I have tingling pains and most recently, after 21 days of being vaccinated the tingling is turning into painful points around my calf, knee and foot. My leg remains numb on day 22 after vaccination without signs of getting better.
BACKGROUND NOTE: I had Covid mid-January ands ome of the lingering effects have been to my smell (still very diminished) and taste (greatly improved but still not 100 percent). .   Following Sat. 4/10 first vaccination, I had some of the normal side effects starting  overnight Saturday night (fatigue chills nausea) which continued through Sunday and Monday and have generally improved since then though still not 100%..    However I am having more smell and taste issues including an after taste issue which I have not had before. The smell taste and after taste are not ones I have seen cited as a typical side effect so that is the main reason for my question regarding whether this is normal and should quickly subside or if it is not normal so it is documented and if it affects timing or if I have the second dose. Hope that makes sense.
patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) 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) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was reported.  It was reported that there have been no power outages that would have impacted the Moderna vaccine. However, reporter reiterated that because her facility was unable to download the digital data logger, they would need to treat this issue as a temperature excursion. The data logger that caller was unable to download for the months of DEC2021, JAN2022, and FEB2022. Reporter said that they are filling out a temperature excursion assessment with the State at this time and she was calling in to report the same to Moderna.  Reporter confirmed that patients have been administered doses while the temperature excursion assessment has been ongoing. It was reported that no adverse reactions were reported by any patients.
This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in an elderly male patient who received SHINGRIX for prophylaxis. On 28th March 2019, the patient received SHINGRIX. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced injection site swelling, injection site redness, injection site pain and injection site rash. On an unknown date, the outcome of the injection site swelling, injection site redness and injection site pain were recovered/resolved and the outcome of the injection site rash was not recovered/not resolved. It was unknown if the reporter considered the injection site swelling, injection site redness, injection site pain and injection site rash to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient developed redness, swelling and soreness around the injection site but those effects had all resolved. The patient had a rash that developed in the same area, but it had spread down his bicep at the time of reporting. The patient terminated the call to see medical attention.
COVID-19; COVID-19; Heart issue; Arthritis; MARKETING PROGRAM NAME NOT AVAILABLE.  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4340975-00 (Company).  A 57 year-old patient received bnt162b2 (BNT162B2), intramuscular, administration date 05Apr2021 (Batch/Lot number: unknown) at the age of 57 years as dose 2, single and intramuscular, administration date 12Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) at unk (citrate free) for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (hospitalization, medically significant), SUSPECTED COVID-19 (hospitalization, medically significant) all with onset Aug2021, outcome "recovered" and all described as "COVID-19"; CARDIAC DISORDER (hospitalization) with onset Aug2021, outcome "recovered", described as "Heart issue"; ARTHRITIS (non-serious), outcome "recovered", described as "Arthritis". The patient was hospitalized for drug ineffective, suspected covid-19, cardiac disorder (start date: Aug2021). The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (Aug2021) covid-19. The action taken for adalimumab was unknown.  Clinical course: Pfizer Biontech Covid-19 vaccine (Tozinameran) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 vaccine Trial. Causality for Humira (Adalimumab): The reporter's causality for the event(s) of Covid -19 and heart issue was not provided. The reporter's causality for the event(s) of arthritis with Humira (Adalimumab) was a reasonable possibility. Company's opinion is that there is no reasonable possibility that the events of Covid -19 and arthritis are related to Humira (Adalimumab). Company's opinion is that the event of heart issue is not assessable. Causality for Pfizer Biontech Covid-19 Vaccine (Tozinameran): The reporter's causality for the events of Covid -19, arthritis and heart issue was not reported.   The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: The efficacy of a drug varies from patient to patient and may be influenced by multiple factors, including the virulence of the infecting pathogen, inherent disease condition, concurrent medical conditions, and concomitant medications, however, a contributory role of the suspect drug cannot be excluded for the reported events of drug ineffective and COVID 19.  Reported event of cardiac disorder and arthritis could be due to an intercurrent medical condition, unrelated to the suspect drug.
pt recv vax 22OCT98 & exp arm swelling, red, painful & low grade fever & chills;possible cellulitis;
One day post vax, pt awoke with rash all over and fever but no respiratory problems or face swelling. He was seen on 6/29/01 for negative PPD and had improved.
This spontaneous report was received from a pharmacist who reported that five infant patients between 2 and 10 months of age (gender not provided) were inadvertently administered a third dose of PEDVAXHIB (dose, route, frequency and lot# not provided) two months after a second dose. No adverse effects were reported. Follow up information was received from the pharmacist. Patient identifiers (initials and birthdates) were provided. Lot numbers and expiration date were unavailable at this time. This is one of several reports received from the same source. Additional information has been requested.
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 31Oct2022 at 10:00 as dose 6 (booster), single (Lot number: 9J3275) at the age of 72 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 4 (booster), single (Batch/Lot number: unknown) and as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "CAD disease" (unspecified if ongoing); "Prostatectomy", start date: 2014, stop date: 2014. The patient's concomitant medications were not reported. Past drug history included: Lisinopril, reaction(s): "Known allergies: Lisinopril allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19, which included Paxlovid treatment from 01May2023 to 07May2023.
Redness, soreness, edema to elbow.  Additionally pain in back, hips, legs, neck, shoulder and left thumb
Subcutaneous nodule; This non-serious spontaneous Safety Report, with reference number 02162368, was received by on 09-May-2022 and forwarded on 10-May-2022, from a health care provider.  This case was considered non-valid due to no patient identifiers provided.  The reporter did not provide an assessment of the causal relationship between VAXELIS and the reported event "6 of 10 patients (unknown by reporter), who received VAXELIS developed a knot/lump at the vaccination site".  Further information is expected.  SIGNIFICANT FOLLOW-UP INFORMATION, with reference number 02162368 (Interaction # 02162362), was received by on 27-May-2022 and forwarded on 01-Jun-2022 from a Health Professional.  The case is maintained as non-serious and became valid since the reporter provided one patient ID.  The reporter assessed the updated event "Subcutaneous nodule" as not related to Vaxelis.  Further information is expected.  Linked case: MCM-003552 (same reporter).
On 12/05/00, Wednesday night, the patient's body ached, headache, arms red, swollen. Took Ibuprofen, Doxycycline ordered by the PMD. Today arm red all away around, swollen, itchy, painful encouraged to recall HCP. On 12/19/00 the patient states arm much better, less red and swollen, but still firm and itching at the injection site. To call for an appt with HCP when road conditions improve.
Rash - developed approximately 9 days after receiving vaccines. Few scattered erythematous papules.
Patient passed away unrelated to covid vaccine Narrative: 87 YO male has relapse lung cancer and was on radiation therapy and chemotherapy in hospital. Patient received his first dose of Pfizer vaccine on 1/28/2021 (as advised 1.5 weeks after administration of chemotherapy in between cycle) and no adverse reaction was reported. Cause of death not documented. No indication that death was related to COVID 19 vaccination.
inflammatory reaction; fever; chills; myalgia; arthralgia; This spontaneous case was reported by a consumer and describes the occurrence of INFLAMMATION (inflammatory reaction), PYREXIA (fever), CHILLS (chills), MYALGIA (myalgia) and ARTHRALGIA (arthralgia) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 020H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Nov-2022, the patient received fifth 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 INFLAMMATION (inflammatory reaction), PYREXIA (fever), CHILLS (chills), MYALGIA (myalgia) and ARTHRALGIA (arthralgia). At the time of the report, INFLAMMATION (inflammatory reaction), PYREXIA (fever), CHILLS (chills), MYALGIA (myalgia) and ARTHRALGIA (arthralgia) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  He stated he never had any reaction to any other vaccine except inflammatory reaction, fever, chills, myalgia, and arthralgia.  No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-745277, US-MODERNATX, INC.-MOD-2023-745286 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-745277:Master case ( New varient case) US-MODERNATX, INC.-MOD-2023-745286:monovalent case
I was so sick; almost killed me; Initial information received on 21-Oct-2021 regarding an unsolicited valid serious case received from a consumer or non-healthcare professional via social media.  This case involves a patient (unknown demographic) was so sick (illness) and almost killed me (unevaluable event) after receiving vaccine INFLUENZA VACCINE.  It was unknown if the patient had any medical history, concomitant disease or risk factor.   The patient past medical treatment, vaccination, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a serious had so sick (illness) (unknown latency) and almost killed me (unevaluable event) 2 days following the administration of INFLUENZA VACCINE.   The patient was hospitalized for this event illness at 5 day.  It was unknown if there were lab data/results available.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was unknown for the reported events.   There will be no information available on the batch number for this case.; Sender's Comments: This case involves a patient (unknown demographic) who had illness and unevaluable event after vaccination with INFLUENZA VACCINE (produced by unknown manufacturer). The time to onset is unknown for illness and compatible for unevaluable event.The patient was hospitalized for this event illness at 5 day.Additional information regarding patient's lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.
"Cried from 10 pm to midnight, uncomfortable, flushing". No vomit and no fever, no diarrhea, no pain, no SOB. No lump at site, no swelling, no redness at site of injection". Next day recovered reports mom.
persistant nausea/nausea become much worse on day 4; fatigue; slight appetite loss; unable to eat normally; lost much weight; This is a spontaneous report from a contactable consumer reported for herself.   A 62-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE;lot EM980) , on 04Feb2021 at 16:00 (at 62 years) at single dose in left arm for covid-19 immunisation .  Medical history included glucose intolerance.  Patient was not pregnant.Concomitant medication included atenolol and calcium/ergocalciferol (CALCIUM/VITAMIN D).  The patient previously took sulfamethoxazole/trimethoprim (BACTRIM) and experienced allergy.  On 08Feb2021 at 08:00 (as reported) the patient experienced persistent nausea, fatigue, slight appetite loss, unable to eat normally and lost much weight, all non serious. Events were described as follows: patient had persistent nausea. The first few days she had the expected side effects of fatigue and slight appetite loss.  The fatigue resolved on the second day, but the nausea become much worse on day 4.  She had been unable to eat normally since then and had lost much weight that she cannot afford to lose. She kept hoping that it will go away, but it was 8 days after her shot and she still had nausea (as reported).  Anti nausea medicine was administered, no treatment given for the other events. Patient recovered from fatigue in Feb2021; outcome of the other events was not recovered.
fever; shivering; arm pain; could not move her arm for 2-3 days; This case was reported by a other health professional and described the occurrence of fever in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (1st dose received on an unknown date and experienced sore arm, refer case US2021AMR186265).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fever, shivering, pain in arm and injected limb mobility decreased. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the fever, shivering, pain in arm and injected limb mobility decreased were recovered/resolved.   It was unknown if the reporter considered the fever, shivering, pain in arm and injected limb mobility decreased to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received her second Shingrix shot and her reaction was bad.  She had a 102 degree F fever and could not her fever down and was shivering.  Also she had arm pain (in the injected arm) which was more severe and she could not move her arm for 2 to 3 days.  The patient stated that, she could not do anything with that arm. The events were since resolved. The patient asked, where she could find the ingredients in the shingrix vaccine, she had a bad reaction and need to compare the ingredients with the Covid vaccines.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR186265:same reporter
On the morning after my second vaccine,I awoke with tremendous body aches and a headache. As the day went on I became more and more fatigued. I developed chills over the day as well but no fever until evening hours. My temperature before I retired for the evening at 7:30 PM was 99.9 Fahrenheit.  Day to post second vaccine still achy and a headache, less fatigue, no fever.  Reported to work both days as I am currently telecommuting for my job.
Severe headache and muscle/joint pain that began about 15 hours after injection.  Trying Tylenol but it doesn't help very much.
Aching joints at 8p.m. followed by severe chills through the night. After restless sleep, woke with headache, body aches, general fatigue through the next day.
ACTHIB component of PENTACEL given with sterile water instead of being reconstituted with the DTaP-IPV component.- with no reported adverse event; Initial information was received on 14-Sep-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 4 months old male patient who experienced acthib component of pentacel given with sterile water instead of being reconstituted with the dtap-ipv component.- with no reported adverse event while receiving vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)].   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for Immunisation; and ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) for Immunisation.  On 13-Sep-2022, the patient received 0.5 ml of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (lot UJ641AAA and expiry-28-02-2024) (strength and administration site: unknown) via intramuscular route for immunization.    On 13-SEP-2022 the patient developed a non-serious acthib component of pentacel given with sterile water instead of being reconstituted with the dtap-ipv component.- with no reported adverse event (product preparation error) (latency same day) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE.  Action taken with DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV AND HIB VACCINE (PENTACEL (VERO)) was not applicable.  At time of reporting, the outcome was Unknown for the event acthib component of pentacel given with sterile water instead of being reconstituted with the dtap-ipv component.- with no reported adverse 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.
the rash became pink but it still itched and each day it fades a little bit; severe lower back pain; red rash on the arm that was slightly swollen, itchy and warm to the touch; swellen; sore arm; A spontaneous report was received from a consumer concerning a 73-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events sore arm, red rash on the arm that was slightly swollen, itchy and warm to the touch, severe lower back pain, the rash became pink but it still itched and each day it fades a little bit.  The patient's medical history was not provided. Concomitant medications reported were Armour Thyroid for drug use for unknown indication.  On 4 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 039K20A) intramuscularly for prophylaxis of COVID-19 infection.  On 4 Feb 2021, the patient experienced the event(s) sore arm . On 11 Feb 2021, the patient experienced the event(s) red rash on the arm that was slightly swollen . On 11 Feb 2021, the patient experienced the event(s) itchy and warm to the touch . On 12 Feb 2021, the patient experienced the event(s) severe lower back pain . On 15 Feb 2021, the patient experienced the event(s) the rash became pink but it still itched and each day it fades a little bit.  Treatment details included, mRNA-1273 mRNA-1273 Adverse Event Not Applicable.  Action taken with mRNA-1273 in response to the events was not applicable.  The outcome of event(s), sore arm was unknown.The outcome of event(s), red rash on the arm that was slightly swollen was unknown.The outcome of event(s), itchy and warm to the touch was unknown.The outcome of event(s), severe lower back pain was unknown.The outcome of event(s), the rash became pink but it still itched and each day it fades a little bit was unknown..