chrisvoncsefalvay/vaers-outcomes huggingface dataset:
arm is very sore and tender; Headache; whole body just aches; chills; feel like I have to vomit but I can't; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm is very sore and tender), HEADACHE (Headache), MYALGIA (whole body just aches), CHILLS (chills) and NAUSEA (feel like I have to vomit but I can't) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Apr-2021, the patient experienced PAIN IN EXTREMITY (arm is very sore and tender), HEADACHE (Headache), MYALGIA (whole body just aches), CHILLS (chills) and NAUSEA (feel like I have to vomit but I can't). At the time of the report, PAIN IN EXTREMITY (arm is very sore and tender), HEADACHE (Headache), MYALGIA (whole body just aches), CHILLS (chills) and NAUSEA (feel like I have to vomit but I can't) had resolved.            Treatment details were not provided.  Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to MOD-2021-079210 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: The outcomes of the events were updated. The reporter declined further follow-up.
Patient reported confusion, "clogged throat" and nausea. RN took vital signs and asked MD to come assess the patient. MD determined epinephrine administration was appropriate. 0.3mg epi administered IM with epi-pen autoinjector and EMS called. EMS administered Benadryl and took the patient to the ED.
psychotic reaction a couple of days; redness, swelling, and pain around the injection site; redness, swelling, and pain around the injection site; redness, swelling, and pain around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PSYCHOTIC DISORDER (psychotic reaction a couple of days) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Plasma cell disorder.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Jan-2021, the patient experienced INJECTION SITE ERYTHEMA (redness, swelling, and pain around the injection site), INJECTION SITE SWELLING (redness, swelling, and pain around the injection site) and INJECTION SITE PAIN (redness, swelling, and pain around the injection site). On an unknown date, the patient experienced PSYCHOTIC DISORDER (psychotic reaction a couple of days) (seriousness criterion hospitalization). At the time of the report, PSYCHOTIC DISORDER (psychotic reaction a couple of days) outcome was unknown and INJECTION SITE ERYTHEMA (redness, swelling, and pain around the injection site), INJECTION SITE SWELLING (redness, swelling, and pain around the injection site) and INJECTION SITE PAIN (redness, swelling, and pain around the injection site) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment medication use was not provided by the reporter.  Company comment: This is a female patient who experienced psychotic disorder among other non-serious events after 1st dose of mRNA-1273. Very limited information regarding this event has been provided at this time. Discharge summary is required for further assessment.; Sender's Comments: This is a female patient who experienced psychotic disorder among other non-serious events after 1st dose of mRNA-1273. Very limited information regarding this event has been provided at this time. Discharge summary is required for further assessment.
Developed rash all over upper body Tylenol prn, Fluid. Pediatrician appt 5/1/19
Fever 105. Admitted hospital 04/24-04/27. Headache, Myalgia and Fever.
Information has been received from a physician and a practice manager via company representative referring to a patient of unknown age and gender. On 23-APR-2015 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23-10PK-0.5mISD-PFS LLokwTip) (lot # K019386, expiration date 09-JUN-2016). This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time was 1080 hours with the lowest recorded temperature of 27 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
severe biopsy proven perniosis of bilateral hands; headaches; fatigue; left sided facial numbness; This is a spontaneous report from a contactable physician. A 36-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not provided), intramuscular on left arm on 16Dec2020 at single dose for COVID-19 immunization. Medical history was reported as none. The patient's concomitant medications were not reported. The patient has no known allergies and was not pregnant. She was not diagnosed with COVID prior to vaccination and has no other vaccine in four weeks. The patient received her vaccine at a clinic. On 16Dec2020, the patient developed severe biopsy proven perniosis of bilateral hands, right after the vaccine which was still lasting. She also had headaches, fatigue for 2 weeks post vaccination (as reported) and left sided facial numbness for hours post vaccination. She had pain and swelling of the fingers which inhibits her from working as an nurse. She has been on disability leave from work. All lupus and other autoimmune work up have been negative. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/ department or urgent care. Therapeutic measures were taken as a result of the events and included treatment with amlodipine, prednisone course, topical steroids and pentoxifylline. The patient underwent lab test and procedure which included nasal swab which was negative post vaccination on an unspecified date. The outcome of the events was not recovered. The events were assessed as serious causing disability or permanent damage.   Information on the lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the perniosis of bilateral hands and other reported events  due to temporal relationship  Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications.  There is limited information provided in this report. This case will be reassessed upon receipt of follow-up information.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 20-NOV-2012, the patient was inoculated with the ZOSTAVAX (lot number, dosage, and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 05-NOV-2013, the patient was treated for a persistent and severe vesicular rash, which was diagnosed as herpes zoster. The patient was prescribed valacyclovir, tramadol and LYRICA for management of his painful symptoms and chronic pain. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
DURING SITE VISIT REVIEW WITH LOCAL DOH, WE FIGURED OUT HIS AGE WAS TOO YOUNG TO GET THE COVID 19 VACCINE AT THAT MOMENT.
Greater than 35 days from the first Moderna Covid-19 vaccine prior to receiving the second Moderna Covid-19 vaccine.; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Greater than 35 days from the first Moderna Covid-19 vaccine prior to receiving the second Moderna Covid-19 vaccine.) in a patient of an unknown age and gender 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form(s). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Greater than 35 days from the first Moderna Covid-19 vaccine prior to receiving the second Moderna Covid-19 vaccine.). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Greater than 35 days from the first Moderna Covid-19 vaccine prior to receiving the second Moderna Covid-19 vaccine.) had resolved.            No concomitant medications were reported.  No laboratory details were  provided.  No treatment medications were reported.  Action taken with mRNA-1273 in response to the events was not applicable.
1130AM 9FEB96 started crying-really fussy-higher pitch cry-unable to comfort;gave APAP;t101-102, 103;2AM 10FEB96 stopped breathing;p/calling pt name, rocking pt-mom blew in face;color-pale, heat in hands gone;called MD; was ill;
DEVELOPED A RASH AROUND SITE ABOUT 1 INCH IN RADIUS UPPER LEFT ARM
TENIVAC administration too early with no adverse event; Initial information received  on 14-Sep-2022 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 79 years old female patient for whom tenivac administration was too early with no adverse event while receiving vaccine DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included INFLUENZA VACCINE INACT SPLIT 4V (FLUZONE HIGH DOSE QUADRIVALENT) for Immunisation.  On 13-Sep-2022, the patient received suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT at a dose of 0.5 ml total (lot U7549AA, expiry date: 04-Nov-2024) via intramuscular route in the left deltoid for immunisation.  On 13-Sep-2022 the tenivac administration was too early with no adverse event (inappropriate schedule of product administration) same day latency following the administration of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT.  Action taken: Not applicable.  Corrective treatment: Not reported.  Outcome: Unknown.   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 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.
Death after vaccination; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Death after vaccination) in a patient of an unknown age and gender 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) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.            No concomitant medication details was provided. No treatment medication details was provided.  Company comment: Very limited information regarding the events has been provided at this time. Further information is not expected.; Sender's Comments: Very limited information regarding the events has been provided at this time. Further information is not expected.; Reported Cause(s) of Death: unknown cause of death
4:30pm shot given,  9:00pm chills began, severe headache ,  fever 100.9,  extremely tired. Lasted through Sunday 1/31/2021, evening 8:00pm., Fever continued through Sunday morning 01/31/2021. &  Fatigue continued through 2/2/2021
Initial unsolicited report was received on 05 January 2015 from a consumer who is also the patient. A female patient (date of birth not reported) had received on 03 November 2014 a left arm injection of FLUZONE High Dose (lot number and route of administration not reported) and an unspecified amount of time later, experienced extreme arm pain from shoulder to the elbow. According to the patient, she thinks it might be "nerve damage due to pharmacist error". The patient had an ultrasound and was treated with prednisone for pain. The patient has "received vaccine since 2001" (specific vaccines not reported). As of 05 January 2015, the patient continues to have pain. Outcome was not recovered. Documents held by sender: none.
Smoldering Myeloma his level bumped up 3 months after taking the 2nd dose of Covid vaccine; after receiving the 2nd dose of the vaccine he was sick for 6 weeks; had PVC's for 6-8 week; This is a spontaneous report from a contactable consumer (Patient). A male patient of an unspecified age received BNT162B2 (BNT162B2 Formulation: Solution for Injection, Batch/Lot number: Unknown Expiration Date: Unknown) via an unspecified route of administration on an unspecified date as dose 2, single for Covid-19 immunization. The patient medical history and concomitant medications were not reported. Patient states that he has Smoldering Myeloma, a type of blood cancer. States that he has his levels checked every 3 months and his level bumped up 3 months after taking the 2nd dose of Covid vaccine. Wondering if we have any information on Smoldering Myeloma and the Covid vaccine as he is paranoid about getting the booster. Wondering if his levels are going to go back down. Patient also stated that after receiving the 2nd dose of the vaccine he was sick for 6 weeks, had premature ventricular contractions (PVC) for 6-8 weeks. States that he treated with Magnesium and started feeling better. States that he is not calling to report an AE, just looking for answers. The outcome of event was recovering.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Heart failure; Renal failure; Acute renal failure; Cardiac dysfunction; Shortness of breath; Not producing urine; Lower extremity edema; A spontaneous report was received from a physician concerning an 85-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced shortness of breath, not producing urine, lower extremity edema, acute renal failure, cardiac dysfunction, renal failure, and heart failure.  The patient's medical history, as provided by the reporter, included COVID-19 three months ago. Patient had no prior history of heart failure. No Concomitant medications were reported.  On 05 Mar 2021, prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection.   After four days, the patient presented at the hospital with a constellation of symptoms including shortness of breath, lower extremity edema, acute renal failure, cardiac dysfunction, not producing urine. Patient was determined to be in renal failure and heart failure. For treatment of the events the patient was admitted to the hospital.  Action taken with mRNA-1273 in response to the events was not reported.   The seriousness criteria for all the events was hospitalization.  The outcome of the events, shortness of breath, not producing urine, lower extremity edema, acute renal failure, cardiac dysfunction, renal failure, and heart failure was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
About 11-12 hours after the 2nd Moderna vaccine, expected arm soreness occurred. I reached to flip on a light switch and pain shot through the injection site down to my elbow. My arm throbbed at night for months. I had an upcoming appointment with an NP in April. I thought we could discuss at that time. It was postponed (due to provider illness). In May, the pain continued and we set up times to go for Physical Therapy. I did weekly therapy (about 5x) and it did seem to ease.  I continue to have soreness in my left arm area but the throbbing has stopped.
pt became weak, dizziness & BP 90/70, P96, R 32;some vomiting occurred;responsiveness somewhat shallow;skin very wet & cool to touch;given med;
COVID 19 Treatment; COVID 19 Treatment; BNT162B2, BNT162B2 OMI BA.4-5 used as dose 1; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 on 12Sep2022 as dose 1, single (Lot number: GH9694) at the age of 63 years, in left arm for Covid-19 immunisation. The patient didn't receive BNT162b2. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: WRONG PRODUCT ADMINISTERED (non-serious) with onset 12Sep2022, outcome "unknown", described as "BNT162B2, BNT162B2 OMI BA.4-5 used as dose 1"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 and including Paxlovid treatment from 15Nov2022 to 19Nov2022.  Product investigation summary conclusion on 24Jan2023 included the complaint for ''Pfizer BioNTech COVID-19 Vaccine'' was investigated. The investigation included reviewing the involved batch records, deviation investigation, an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot GH9694. A complaint sample was not returned. No related quality issues were identified during the investigation. There was no impact on product quality, regulatory, validation and stability. Withheld concludes that the reported defect was not representative of the quality of the batch and the batch remains acceptable. The NTM process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed.  Follow-up attempts completed. No further information expected.  Follow-up (24Jan2023): This is a follow-up report from product quality group providing investigation results.  Updated information included: Product investigation summary conclusion, new suspect vaccine BNT162b2, BNT162b2 omi ba.4-5 added based on lot number and it confirmed previously suspect vaccine BNT162B2 was not administered, new non-serious event "BNT162B2, BNT162B2 OMI BA.4-5 used as dose 1" added and considered as wrong vaccine administered.
Noticed pinkish area at injection site. Only mildly sensitive when touched directly with finger, otherwise not noticeable. No arm soreness either; This is a spontaneous report received from non-contactable reporter (Consumer or other non HCP) from a sales representative.  An adult male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 05Oct2022 as dose 4 (booster), single (Lot number: GH9693) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose:01, Manufacturer: Unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose:02, Manufacturer: Unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose:03, Manufacturer: Unknown), for COVID-19 Immunization. The following information was reported: VACCINATION SITE DISCOLOURATION (non-serious) with onset 06Oct2022, outcome "recovering", described as "Noticed pinkish area at injection site. Only mildly sensitive when touched directly with finger, otherwise not noticeable. No arm soreness either". Therapeutic measures were not taken as a result of vaccination site discolouration.  No follow-up attempts are possible. No further information is expected.
It hurt; This case was reported by a consumer via interactive digital media and described the occurrence of injection site pain in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Covid vaccine with an associated reaction of injection site pain (received covid shot on an unknown date and experienced injection site pain).   In November 2021, the patient received Shingles vaccine. In November 2021, less than a week after receiving Shingles vaccine, the patient experienced injection site pain. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingles vaccine.  Additional details were provided as follows: The case was self reported by the patient. The age at vaccination was not reported. The reporter stated that, she got her shot over the weekend and it hurted more than the Covid shot.  The patient took a Tylenol. The patient's husband told her that, she must be in pain, as she didn't take the medications. The follow-up would not possible as no contact details were available.
fatigued for 1½ days; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigued for 1½ days) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     No Medical History information was reported.   On 13-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FATIGUE (fatigued for 1½ days). At the time of the report, FATIGUE (fatigued for 1½ days) had resolved. Not Provided          The action taken with mRNA-1273(Moderna COVID-19 Vaccine) was not applicable  No concomitant medications were reported  No treatment drugs were reported
Large red itchy reaction to right thigh. No pain no fever. Treatment: BENADRYL, hydrocortisone.
Facial edema and upper lip edema Multiple episodes of edema in different body parts (hands, face)