chrisvoncsefalvay/vaers-outcomes huggingface dataset:
no adverse effects; patient have been administered doses of improperly stored vaccines; This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical histories provided. On 23-MAR-2020, the patient was vaccinated with improrperly stored doses of  haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) lot # S030965 with expiration date of 03-APR-2022(upon internal validation) 0.5 milliliter, intramuscular in the right thigh for prophylaxis; pneumococcal vaccine (unspecified)(PNEUMOCOCCAL VACCINE (UNSPECIFIED)) and diphtheria toxoid, hepatitis b virus vaccine rhbsag (yeast), pertussis acellular 3-component vaccine, poliovirus vaccine inactivated (vero), tetanus toxoid(PEDIARIX). No adverse events were reported.     This is one of several reports from the same reporter ; Sender's Comments:  US-009507513-2003USA002275:Original Case : 2003USA002275 US-009507513-2008USA008883:Original Case : 2003USA002275 US-009507513-2008USA008876:Original Case : 2003USA002275 US-009507513-2008USA008875:Original Case : 2003USA002275 US-009507513-2008USA008877:Original Case : 2003USA002275 US-009507513-2008USA008878:Original Case : 2003USA002275 US-009507513-2008USA008879:Original Case : 2003USA002275 US-009507513-2008USA008880:Original Case : 2003USA002275 US-009507513-2008USA008881:Original Case : 2003USA002275 US-009507513-2008USA008884:Original Case : 2003USA002275 US-009507513-2008USA008886:Original Case : 2003USA002275 US-009507513-2008USA008887:Original Case : 2003USA002275 US-009507513-2008USA008888:Original Case : 2003USA002275 US-009507513-2008USA008889:Original Case : 2003USA002275 US-009507513-2008USA008890:Original Case : 2003USA002275 US-009507513-2008USA008891:Original Case : 2003USA002275 US-009507513-2008USA008892:Original Case : 2003USA002275 US-009507513-2008USA008893: US-009507513-2008USA008894: US-009507513-2008USA008895: US-009507513-2008USA008896: US-009507513-2008USA008897: US-009507513-2008USA008898: US-009507513-2008USA008899: US-009507513-2008USA008900: US-009507513-2008USA008901: US-009507513-2008USA008902: US-009507513-2008USA008903: US-009507513-2008USA008904: US-009507513-2008USA008905: US-009507513-2008USA008906: US-009507513-2008USA008907: US-009507513-2008USA008908: US-009507513-2008USA008909: US-009507513-2008USA008910: US-009507513-2008USA008911: US-009507513-2008USA008912: US-009507513-2008USA008913: US-009507513-2008USA008914: US-009507513-2008USA008915: US-009507513-2008USA008916: US-009507513-2008USA008917: US-009507513-2008USA008918: US-009507513-2008USA008919: US-009507513-2008USA008920: US-009507513-2008USA008921: US-009507513-2008USA008922: US-009507513-2008USA008923: US-009507513-2008USA008924: US-009507513-2008USA008925: US-009507513-2008USA008926: US-009507513-2008USA008927: US-009507513-2008USA008928: US-009507513-2008USA008929: US-009507513-2008USA008930: US-009507513-2008USA008931: US-009507513-2008USA008931: US-009507513-2008USA008932: US-009507513-2008USA008933: US-009507513-2008USA008886:
Sciatica pain; diarrhea; Lousy; feeling Queasy; Vaccination site lump; This spontaneous case was reported by a patient and describes the occurrence of SCIATICA (Sciatica pain), VACCINATION SITE MASS (Vaccination site lump), DIARRHOEA (diarrhea), FATIGUE (Lousy) and NAUSEA (feeling Queasy) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006m20a) for COVID-19 vaccination.     Concurrent medical conditions included Sciatica and Allergy to arthropod sting. Concomitant products included IBUPROFEN, PHENYLEPHRINE HYDROCHLORIDE (ADVIL SINUS CONGESTION & PAIN) for Sinus disorder, VITAMIN B NOS for Supplementation therapy.    On 18-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced VACCINATION SITE MASS (Vaccination site lump). On 18-Mar-2021, the patient experienced SCIATICA (Sciatica pain), DIARRHOEA (diarrhea), FATIGUE (Lousy) and NAUSEA (feeling Queasy). At the time of the report, SCIATICA (Sciatica pain), VACCINATION SITE MASS (Vaccination site lump), DIARRHOEA (diarrhea), FATIGUE (Lousy) and NAUSEA (feeling Queasy) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medication information was given. It was reported that patient blood work was done.   This case was linked to MOD-2021-235635 (Patient Link).
The vaccine that was administered had been sitting at room temperature for 7 hours before it was injected into the patient.  Janssen was notified and reported us to use our clinical judgment.
11/26/21 presents to EC ED for "NP Cough associated with nausea". PMHx of "GERD, Hyperlipidemia, Depression, Anxiety and OA".
had swelling off and on in different limbs but not in this arm; after he had the Pfizer Covid vaccine, left arm had gotten bigger/arm that he got it in was swollen, almost the entire arm; had swelling off and on in different limbs but not in this arm; after he had the Pfizer Covid vaccine, left arm had gotten bigger/arm that he got it in was swollen, almost the entire arm; This is a spontaneous report from a contactable physician (patient himself). A 46-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in the left arm on an unspecified date (Batch/Lot number and Expiration date were not reported) as the 1st dose, single for COVID-19 immunization. Relevant medical history included an accident a year prior reporting in 2020 and had swelling off and on in different limbs, but not in this arm from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient stated that he received two doses of the Pfizer vaccine, the last one was one week prior reporting. He stated that the arm that he got it in was swollen, almost the entire arm and wanted to know if he needed to get it checked out. The patient further stated that he had an accident a year prior reporting and had swelling off and on in different limbs, but not in this arm; he stated that after he had the Pfizer Covid vaccine, the left arm had gotten bigger on an unspecified date. The outcome of the event was unknown.  Information on the batch/lot number has been requested.; Sender's Comments: The contributory role of the suspect product BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in the left arm on an unspecified date (Batch/Lot number and Expiration date were not reported) to reported events is possible based on temporal association and known profile of the product.
"feeling faint"  elevated BP and   profound  fatigue X  5  weeks  post  vaccine
Pt reported blurriness of (L) eye, originally saw a small shadow in bottom left of vision of (L) eye in the shape of a quarter moon and has progressed to a half-moon shape in (L) eye.
Patient reported numbness and loss of use of her left arm. She reported being weak and barely able to walk. She went to the ER today (after 4 days) to receive fluids and is feeling better.
Patient received 1st dose of vaccine on 3/14/21 and was admitted to hospital on 4/6/21 with a chief complaint of fever and dry cough and a reported positive COVID-19 test from an outside testing facility  on 4/4/21.
Swelling, bruising, warm to touch at injection site. Treatment recommended: BENADRYL PO. Lasted 6 days.
No adverse event; Pediatric dose was given to adults mistakenly; Moderna COVID-19 vaccine administered to patients post temperature excursion; Poor quality vaccine administered; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patients post temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR5186C) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2022, the patient experienced WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patients post temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patients post temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patients post temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered).    Concomitant product use was not provided by the reporter. It was reported there was a temperature excursion between 26 May 2022 to 30 Sep 2022 and lot AR5186C was affected between 08 Sep 2022 to 27 Sep 2022. AR5186C was previously reported. Pediatric dose was given to adults mistakenly and were reported to CDPH, VAERS, CAIR and each patient that received the error dose, with instructions to re-vaccinate 2 months from the initial error dose. 051B22A was kept in the freezer upon receipt of shipment on 01-Aug-2022 and individual vials were put in the refrigerator on the day of use. No treatment information was provided. This case contains information for the 06th of 104 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-669791 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-669791:Master
The 2nd injection in November nearly caused my daughter to pass out.  She had to lie down & drink some water.  The third injection on Feb. 26 was the most painful, with a burning sensation flowing down her arm toward her hand.  Approximately 5 days after the injection, she began experiencing very sharp pain in the shoulder she received the injection in.  Continues to be in moderate pain, especially with movement of shoulder.
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Hypertension-Severe, Systemic: Tachycardia-Severe
Diarrhea on 7/6 - 9:11am and  3:18pm Diarrhea on 7/8 - 4:07pm Fever 7/10 8am - 7/12  up to 102 Fatigue 7/10 - 7/12
that night after vaccines - bloody stool, motor tics, tongue protrusion, no longer made eye contact, no longer smile or laugh when already laughing out loud weeks before, lethargic - signs of encephalopathy, severe eczema and food/environmental allergies
Tingling in arms, hands, feet and head; This spontaneous case was reported by a physician and describes the occurrence of PARAESTHESIA (Tingling in arms, hands, feet and head) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (unknown route) at an unspecified dose. On an unknown date, the patient experienced PARAESTHESIA (Tingling in arms, hands, feet and head). At the time of the report, PARAESTHESIA (Tingling in arms, hands, feet and head) outcome was unknown.        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 medications provided.
I noticed red hives around the injection site today and my arm feels heavy, The injection site feels a little hard to the touch. It is a little warm as well.
Started the next day as a patch under left arm, same arm as injection.  No fever. No reaction to 1st vaccine.  Cheeks with red patches bilaterally, left inner upper arm with red patch with vesicles in middle, vesicles present to right ear, upper chest and neck (front and back) as well. Chest and neck with erythema patches. Scattered red papular lesions all over, varying size from pinpoint to dime sized..
Could not get out of bed for 24 hours; Had flu-like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Had flu-like symptoms) and FATIGUE (Could not get out of bed for 24 hours) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 012L20A) for COVID-19 vaccination.     Concurrent medical conditions included Irritable bowel syndrome. Concomitant products included ATORVASTATIN and CITALOPRAM for an unknown indication.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced INFLUENZA LIKE ILLNESS (Had flu-like symptoms). On 23-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FATIGUE (Could not get out of bed for 24 hours). On 23-Feb-2021, FATIGUE (Could not get out of bed for 24 hours) had resolved. At the time of the report, INFLUENZA LIKE ILLNESS (Had flu-like symptoms) outcome was unknown.      Treatment information was not provided.   This case was linked to MOD-2021-335120, MOD-2021-335141 (Patient Link).
Rheumatoid arthritis flare up; Generalized aching/ body aches; Route Of Administration: Subcutaneous; This is a solicited report based on the information received by Pfizer from Regulatory Authority. (Mfr. Control No.: 21K-163-4109568-00).   Solicited report from the Regulatory Authority by a contactable 39-year-old female consumer (patient) with events of non-serious Rheumatoid arthritis flare up and body aches from Covid vaccine with Humira (Adalimumab) citrate free, subcutaneous, at unspecified dose and frequency, for moderate to severe rheumatoid arthritis. Medical history and concomitant medications were not reported. In 2021, the patient experienced body aches from Covid vaccine. In Sep2021, the patient experienced rheumatoid arthritis flare up. Pfizer BioNTech Covid-19 vaccine (Tozinameran) was also considered suspect. It was unknown if patient was enrolled in a Covid-19 vaccine trial. On 06Mar2021, she received first dose of Covid-19 vaccine manufactured by Pfizer/BioNTech, lot number and expiry date: unknown, subcutaneous, at the age of 38-years-old, as dose 1, single, for Covid-19 vaccination. On 01Apr2021, she received second dose Covid-19 vaccine manufactured by Pfizer/BioNTech, lot number and expiry date: unknown, subcutaneous, at the age of 38-years-old, as dose 2, single, for Covid-19 vaccination. Outcome of the event rheumatoid arthritis flare up was not recovered, while for generalized aching/ body aches was unknown. The action taken in response to adalimumab was unknown. The reporter's causality for the event of rheumatoid arthritis flare up from the Covid vaccine was not provided, while for generalized aching/ body aches was probable.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the currently available information the possibility of causal association between the reported events and the suspect drug BNT162B2  cannot be ruled out but consider also possible contributory effects from patient's medical history of Rheumatoid arthritis. The case will be reassessed once new information is available.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.
immediately became very ill, 9 days later (03/25/21) patient was found nearly dead, rarced to hospital, on the way there he became unresponsive, ambulance carried him the rest of the way 8 days in icu, 4 days on the floor, discharged with acute non- alcoholic liver non-stem heart attack, DOES NOT DRINK, he exibited a typical behavior, therefor they couldnt get his elevated amonia down, never medically responded,was discharged home, 8 days later condition worsened, he was not medically responding as expected, rectal bleeding, discharged on hospice diagnosed with portal vein thrombosis never went back to normal self. died in 8 weeks
Started to have arm pain, fatigue, body aches about 6 hours after injection. Had body chills and headache appear approximately 12 hours  after injection. Nausea appeared the next morning and by the afternoon I had a fever.
Sore Throat; Pain in the Right Ear; Headache; Shaking After taking Tylenol; Felt like Fainting after taking Tylenol; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 29-Mar-2021 and was forwarded to Moderna on 29-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore Throat), TREMOR (Shaking After taking Tylenol), DIZZINESS (Felt like Fainting after taking Tylenol), EAR PAIN (Pain in the Right Ear) and HEADACHE (Headache) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced TREMOR (Shaking After taking Tylenol), DIZZINESS (Felt like Fainting after taking Tylenol) and HEADACHE (Headache). On 20-Mar-2021, the patient experienced OROPHARYNGEAL PAIN (Sore Throat) and EAR PAIN (Pain in the Right Ear). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency and AMOXICILLIN for Adverse event, at an unspecified dose and frequency. On 04-Mar-2021, TREMOR (Shaking After taking Tylenol) and DIZZINESS (Felt like Fainting after taking Tylenol) had resolved. On 06-Mar-2021, HEADACHE (Headache) had resolved. At the time of the report, OROPHARYNGEAL PAIN (Sore Throat) and EAR PAIN (Pain in the Right Ear) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant details were provided.
Pt (Patient) started feeling confused; She had numbness and tingling on R side; She had numbness and tingling on R side; pain in R leg; headache; This is a spontaneous report from a contactable Physician. A 49-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown, expiration date unknown), via an unspecified route of administration in left arm on 27Jan2021 at 10:45 AM as single dose for COVID-19 immunisation. The patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient was not tested for COVID-19. The patient was allergic to penicillin. The patient medical history included TIA, angina, and restless leg syndrome. Concomitant medication included Asprin 81mg daily. On 29Jan2021 at 09:00 PM, the patient started feeling confused, had numbness, and tingling on right side, pain in R leg and headache. AE resulted in emergency room/department or urgent care. Treatment was received for AE. The outcome of the events was unknown.
I was told to go to the ER by my Doctor a CT and other tests were ran my wife contacted COVID-19 so I had a decent exposure, I eventually contracted it On 12JAN2023 I began to feel ill and had a runny nose, achiness, some coughing felt tired and a sore throat, a fever of one hundred point five and in the morning the fever was gone. My Doctor prescribed Paxlovid. I tested negative on 19Jan2023. On 23Jan2023 I had a rebound case with tiredness, achiness, a minor headache, this lasted longer this time and did not test negative until 01FEB2023.
Initial information received on 02-Nov-2018 regarding an unsolicited valid non-serious case received from a consumer. This case involves a 11 years old female patient who was administered 0.5 ml MENACTRA that was expired on 11-Oct-2018 (Batch number: U5712AB, expiration date: 11-Oct-2018, route and site of administration was not reported) on 01-Nov-2018. The patient's medical history was not reported. Concomitant vaccines included DAPTACEL and GARDASIL. It was an actual medication error due to expired vaccine used. The patient had no AE. 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. List of documents held by sender: none.
Hives all over the body; Fatigue; Headache; Chills; Muscle ache; Fever; Severe sore arm; Sweats; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Severe sore arm), HYPERHIDROSIS (Sweats), URTICARIA (Hives all over the body), FATIGUE (Fatigue) and HEADACHE (Headache) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (Positive).    On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Apr-2021, the patient experienced PAIN IN EXTREMITY (Severe sore arm), HYPERHIDROSIS (Sweats), FATIGUE (Fatigue), HEADACHE (Headache), CHILLS (Chills), MYALGIA (Muscle ache) and PYREXIA (Fever). On 01-May-2021, the patient experienced URTICARIA (Hives all over the body). On 29-Apr-2021, PAIN IN EXTREMITY (Severe sore arm), HYPERHIDROSIS (Sweats), FATIGUE (Fatigue), HEADACHE (Headache), CHILLS (Chills), MYALGIA (Muscle ache) and PYREXIA (Fever) had resolved. At the time of the report, URTICARIA (Hives all over the body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medication included Benadryl and Steroid No concomitant medication was reported.