chrisvoncsefalvay/vaers-outcomes huggingface dataset:
temperature it was very low and it kept fluctuating today/my temperature being extremely low at times; I woke up feeling kind of cold/my hands were really cold; I had little bit of like rash on my arm; I also had little bit last night when I woke up, cold; Just felt really tired; I had little bit of fever; started to feel a little bit achy; This is a spontaneous report received from a 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 30Dec2021 (Lot number: FJ8762) at the age of 38 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: PAIN (non-serious) with onset 30Dec2021, outcome "recovered" (01Jan2022), described as "started to feel a little bit achy"; FATIGUE (non-serious) with onset 31Dec2021, outcome "recovered" (01Jan2022), described as "Just felt really tired"; PYREXIA (non-serious) with onset 31Dec2021, outcome "recovered" (01Jan2022), described as "I had little bit of fever"; BODY TEMPERATURE DECREASED (non-serious) with onset 01Jan2022 03:00, outcome "unknown", described as "temperature it was very low and it kept fluctuating today/my temperature being extremely low at times"; FEELING COLD (non-serious) with onset 01Jan2022 03:00, outcome "unknown", described as "I woke up feeling kind of cold/my hands were really cold"; RASH (non-serious) with onset 01Jan2022, outcome "recovered" (Jan2022), described as "I had little bit of like rash on my arm"; NASOPHARYNGITIS (non-serious) with onset 01Jan2022, outcome "unknown", described as "I also had little bit last night when I woke up, cold". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pain, fatigue, pyrexia, body temperature decreased, feeling cold, rash, nasopharyngitis.  Additional information: Np investigation Assessment. No lab test was reported in past 2 weeks. Treatment: Patient received Aleve (treatment) and had been taken zinc, multivitamins. Facility type was reported as a clinic. No prior vaccination since 4 weeks.   No follow-up attempts are possible. No further information is expected.
pt recv vax 25OCT95 & 19MAR96 pt devel a rash on lt arm w/approx 25-50 vesicles on an erythematous base consistent w/herpes zoster;a cult was obtained for PCR analysis;however, there was inadequate specimen;pt recovered;
This spontaneous case reported by a consumer, describes the occurrence of pain in extremity (sore arm) in a female patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced pain in extremity (sore arm). At the time of the report, pain in extremity (sore arm) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant medication or treatment information provided. This case linked to MOD-2021-358137 (patient link).
pt recv vax OCT96 & 26NOV96 pt devel congestion, sl h/a, exhaustion, & cough requiring med eval;pt has not yet recovered;pt indicated had been vaccinated w/one of the recalled lots, but was unable to ID a specific lot#
Pt received vaccine at 11:00 am. At 11:10a, pt complained of itching and redness on face, but denied shortness of breath and dizziness. Pt vitals were taken and were as followed;  176/88 BP, 100% O2 sat and 97.0 temp before EpiPen administration. EpiPen was administered and the pt sat with the nurse for 15-20mins; where then the redness and itching went away and the pt explained she felt a lot better. Second set of vitals post EpiPen were as followed; 146/70 BP, 100% O2 sat and 97.0 temp. Pt was given follow up directions.
Cramps started again even though just had it last week; Period started again even though just had it last week; This is a spontaneous report from a non-contactable consumer, the patient. A 42-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medication were not reported. On an unknown date, the patient experienced cramps and period started again even though just had it in last week. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. The clinical outcome of the events cramps and period started again were unknown at the time of report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
The pt received her 1st Lymerix injection in March, 1999. In April, 1999, the pt received her 2nd injection of Lymerix and that same night, the pt experienced "bone pain". These symptoms have never gone away and since then her hips and lower back have become very sore and stiff. The pt has been receiving treatment with Biaxin and steroids (nos). Additional information has been requested.
got vaccine after 30 day refrigeration expiration date; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (got vaccine after 30 day refrigeration expiration date) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027c21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (got vaccine after 30 day refrigeration expiration date). On 06-May-2021, EXPIRED PRODUCT ADMINISTERED (got vaccine after 30 day refrigeration expiration date) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment information provided. These administration errors occurred between 7 May 2021 and 26 May 2021, and the vaccines were placed into the refrigerator on 06 Apr 2021.
I woke up 12-16 hours after my 2nd dose with a loud, high pitched noise in both of my ears. (Tinnitus); This is a spontaneous report from a contactable consumer (patient).   A 53-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 29Apr2021 14:30 at age of 53 years old (Lot Number: ew0172) as 2ND DOSE, SINGLE for covid-19 immunisation.  Medical history included many known allergies, but did not react to vaccine. Patient was not diagnosed with COVID-19 prior to vaccination. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 08Apr2021 14:30 PM at age of 53 years old (Lot Number: ew0172) as 1ST DOSE, SINGLE for covid-19 immunisation. After the 1st dose, patient was quite sick, suffered from exhaustion (sleeping 15-17 hrs a day) and a heavy cough, and minor sinus pressure, for the first 2.5 weeks after the 1st dose, noticed a very faint high pitch in ears a few days before the 2nd shot, but dismissed it as an aberration. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication(s) included meloxicam; omeprazole; levocetirizine, all taken for an unspecified indication, start and stop date were not reported.  Patient woke up 12-16 hours after his 2nd dose with a loud, high pitched noise in both of ears (Tinnitus on 30Apr2021 05:00 AM). It has not diminished in the week since the 2nd shot. Patient can hear it while talking on the phone and when laying in bed. Serious criteria was provided as disability and with physician office visit. Patient had hearing tested by an audiologist 5 days after the shot and do not have hearing loss, despite the tinnitus. As a former professional singer, he was diligent about protecting hearing, wearing protection whenever near loud noises. Patient have never had symptoms of Tinnitus prior to the vaccine. The patient underwent lab tests and procedures which included hearing tested on 04May2021: no hearing loss, despite the tinnitus.  Patient was not test for COVID-19 Since the vaccination. The outcome of event was not recovered and without hospitalization and with treatment given.  Information on Lot/Batch number was available. Additional information has been requested.
patient felt lightheaded within 5 minutes of arriving in observation areas. Vitals upon initial symptom reporting BP 158/101, HR 66, O2 sat 97%, temperature 36.9. Patient reported not eating anything this morning prior to arrival at vaccination site. Water, crackers provided. Feet elevated for 30 min and ice packs provided. Vitals 30 min later noted BP 170/78, HR 60, O2 sat 99%. Patient transported to ED via wheelchair with RN for further monitoring.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unspecified age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On 07-JUN-2016, the patient was inoculated with ZOSTAVAX for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On 24-JUN-2016, the patient suffered debilitating injuries including bilateral facial cellulitis, abscesses to her face and eye and peri orbital soft tissue swelling and edema which caused severe pain and disfigurement resulting in hospitalization for approximately four (4) days. As a direct and proximate result of ZOSTAVAX, the patient's symptoms have resulted in physical limitations not present prior to using the product. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of her condition and has suffered economic losses due to her inability to work. As a result of ZOSTAVAX, the patient sustained severe and disfiguring personal injuries. Further, as a tragic consequence of the Company's wrongful conduct, the patient suffered serious, progressive and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The outcome of the events were considered not recovered/not resolved. The aforementioned events were considered related to ZOSTAVAX. Upon internal review, the cellulitis, subcutaneous abscess and eye abscess were considered a medically significant events. All the events were considered to be disabling. Additional information has been requested.
Patient arrived at the pharmacy on 9/14/2021 wanting to receive his 2nd moderna vaccination.  Before he filled out his vaccination questionaire he mentioned that after the firs shot he had a rapid heart rate/heartbeat after receiving the shot.  He did mention that he worked out, but with his apple watch he said it was 152 and never been that high before.  Upon hearing this I told him that it was possible to experience this with Moderna and that side effect was listed under the Myocarditis side effects.  I told him that I wanted to be on the side of caution.  I explained that before we give the second dose that it would best to be on the side of caution and have this checked out by his family physician before we proceed. I explained that this may not be Myocarditis. However I cant rule it out either.  And it would be best to just check things out to make sure, and if he is cleared by his dr then come back for his second dose.    The patient had no issue with this suggestion and knows it is being done on the side of caution.  I explained that we will also call his family dr to let him know of the situation as well.  Patient has been instructed to follow up with his family dr as a side of caution and he agreed.
Redness & severe arm pain from shot area to 5 inches below, allergic reaction on neck and chest, chills for two days, significant numbness and tingling in right arm and two toes of left foot,  sensitivity to anything touching skin whole body.
Red and itchy at injection site Area is slightly raised and firm/hard 2-2 1/2 inch area
Shingles; This is a spontaneous report from a contactable consumer. This 69-year-old Female consumer (patient) reported for herself that: received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, dose 1 (Lot Number: ER8736 expiry date was not reported) via an unspecified route of administration at arm Left on 27Apr2021 (at the age of 69-years-old) as a single dose, dose 2 (Lot Number and expiry date was not reported) via an unspecified route of administration on 19May2021 as a single dose, for covid-19 immunisation. Medical history included herpes zoster from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. It was reported that the patient received vaccine on 19May2021 and got shingles on 27May2021 or 28May2021 (conflictingly reported). The patient reported that It pretty much went away she still has some tingling. The patient received treatment with the prescription she gave her and over the counter ibuprofen. Prescription includes gabapentin 300 mg, capsule, she took it whenever she needed. It was not helping she said she could start taking it every four hours. Outcome of the event was recovering.  Follow-up attempts are needed. Information on Lot/Batch number can be requested
Patient reported the morning of 10/18/2005, fatigue, nausea, swelling to left deltoid.  Wednesday night (10/18/2005) diarrhea and tachycardia.  Experienced visual hallucinations related to lack of sleep.  4x4 cm swelling, redness at injection site.
Sore arm; First Dose 27May2021/Second dose 20Aug2021; faint; temperature dropped to about 96 degrees; feeling of shock happening; dizzy; freezing rash around mouth; Spinal pain; sore arm; sweating; Arthritis; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (faint) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 088D21A and 050C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 27-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-May-2021, the patient experienced ARTHRITIS (Arthritis). On 20-Aug-2021, the patient experienced SYNCOPE (faint) (seriousness criterion medically significant), BODY TEMPERATURE ABNORMAL (temperature dropped to about 96 degrees F), FEELING ABNORMAL (feeling of shock happening), DIZZINESS (dizzy), COLD URTICARIA (freezing rash around mouth), SPINAL PAIN (Spinal pain), PAIN IN EXTREMITY (sore arm), HYPERHIDROSIS (sweating) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First Dose 27May2021/Second dose 20Aug2021). On an unknown date, the patient experienced VACCINATION SITE PAIN (Sore arm). On 20-Aug-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First Dose 27May2021/Second dose 20Aug2021) had resolved. At the time of the report, SYNCOPE (faint), BODY TEMPERATURE ABNORMAL (temperature dropped to about 96 degrees F), FEELING ABNORMAL (feeling of shock happening), ARTHRITIS (Arthritis), DIZZINESS (dizzy), COLD URTICARIA (freezing rash around mouth), SPINAL PAIN (Spinal pain), PAIN IN EXTREMITY (sore arm), HYPERHIDROSIS (sweating) and VACCINATION SITE PAIN (Sore arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-May-2021, Body temperature: 96 (abnormal) 96 F.         No Concomitant medication was reported. No Treatment information was reported.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of events, a causal relationship cannot be excluded. Further information has been requested regarding event dates and seriousness criteria for syncope event.   This case was linked to MOD-2021-294517 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of events, a causal relationship cannot be excluded. Further information has been requested regarding event dates and seriousness criteria for syncope event.
Patient is a 81 y.o. female who was admitted on 1/15/2023 for acute heart failure and elevated troponin.  The patient reported an episode of upper chest discomfort on around 3rd week of Dec.  It abated spontaneously.  She did not have any recurrent symptoms until about 3 days prior to presentation when she developed progressive dyspnea and was just unable to catch her breath.  She endorses orthopnea, PND and bend up knee.  Denied any recurrent chest discomfort.  No palpitations, presyncope or syncope
Temp as high as 103.3 within 12 hrs. Vomiting and diarrhea. Refused liquids and became dehydrated. Lots of crying, but no continuous. At ER, recommended oral rehydration, rather than IV. Redness and lump at injection site. Today has rash suggestive of Roseola.
Patient lost consciousness about 5 minutes after receiving vaccine. Called paramedics, when they arrived he was hypotensive. Patient was taken to hospital for obeservation. He was  AOx3 while he was being transported.
after receiving his initial dose the next day he seemed to have suffered a TIA that took almost a week for him to recovery from. He was confused, no appetite, weak, and generally not himself.  Prior to receiving his second dose he was alert, eating, no complaints of any discomfort or issues. The next day following his second dose he passed away from what we think was a massive heart attack.   As a family we feel his weakened state contributed to this and not the fault of the vaccine but felt it important to notify you in case individuals such as patient should be monitored in a different way or use a different vaccine.
This spontaneous report was received from a pharmacist refers to a 4 year old female patient. The patient's pertinent medical history and drug reactions/allergies were not reported. On an unknown dates (at appropriate times of near 12 months of age), the patient was vaccinated with M-M-R II and VARIVAX, (lot/expiration, dose and frequency not reported). Pharmacist (parents) stated last year (2015), patient developed allergies/asthma that required medication and patient took QVAR, (1 puff twice daily, 40 mcg dose). Pharmacist stated "the allergies/asthma have nothing to do with the vaccines." The outcome of the event was unknown. The reporter considered event to be not related to M-M-R II and VARIVAX (nothing to do with the vaccines). Patient did not seek medical attention. No product quality complaint (PQC) was involved. No further information provided. Additional information has been requested.
Pt presented with mild edema. Mom reported that 1 day, post vax, he developed redness and swelling at the site where the DTAP had been placed. Left arm soak recommended twice a day.
Adverse effect of other vaccines and biological substances, initial encounter on 2022-07-28.
Have had significant muscle/joint pain amd stiffness for last 8-9 months.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Relevant medical history and concomitant medication were not provided. On 05-MAR-2014, the patient was vaccinated with GARDASIL. Lot number, dose, route and frequency were not provided. The vaccine was exposed to 56F for 10 days, an excursion that was found to be unsupported by in-house stability data. No adverse event was reported. Additional information has been requested.
COVID-19; COVID-19; Interchange of vaccine products; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old male patient received bnt162b2 (BNT162B2), on 05Mar2021 at 13:00 as dose 1, single (Lot number: En6199), in right arm, on 26Mar2021 at 14:00 as dose 2, single (Lot number: Ep7533), in left arm, on 19Dec2021 at 15:00 as dose 3 (booster), single (Lot number: 33025bd), in left arm and on 13May2022 at 14:00 as dose 4 (booster), single (Lot number: Fm9992) at the age of 59 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 08Nov2022 at 11:00 as dose 5 (booster), single (Lot number: 049d22a), in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: CALCIUM; ASCORBIC ACID; CHOLECALCIFEROL. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 08Nov2022 at 11:00, outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Anti-viral details included Paxlovid for COVID 19 Treatment (treatment start date=02Oct2023, treatment stop date=07Oct2023; lot number=Gj0891). Other medication in 2weeks product included vitamins: multi, c, d, calcium, airborne dietary supplement (Other medication in 2weeks start date=01Jan2023; Other medication in 2weeks stop date=29Sep2023). None known known allergies, none known Other medical history.
Low grade fever (100.8) lasted a few hours_arm itchy red-Dry mouth!  Achy body    C
I had my first injection of the vaccine in April. I have not had my second one.; had COVID; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (I had my first injection of the vaccine in April. I have not had my second one.) and COVID-19 (had COVID) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (I had my first injection of the vaccine in April. I have not had my second one.) and COVID-19 (had COVID). At the time of the report, PRODUCT DOSE OMISSION ISSUE (I had my first injection of the vaccine in April. I have not had my second one.) and COVID-19 (had COVID) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.     submitted Adverse Event for follow up declined by Patient."Patient had their first injection of the vaccine in April. Patient have not had their second one. Patient also had COVID.  Patient is asking Should  take the second injection now or start all over?"
pt recv vax 26OCT95 & 7NOV95 pt exp a rash & fever;