chrisvoncsefalvay/vaers-outcomes huggingface dataset:
1st shot - Arm was numb and tingly. Patient thought a nerve was pinched.  2nd shot - 2 day after pain in arm worsened (numb, tingling, throbbing and twitching  - very painful), flu-like symptoms (chills, fatigue, dizziness etc.), Fainted and was injured during the fall (took 2 sick days off of work). Cheeks were sore possible immune system over reacting and attaching juvaderm filler in cheeks. Week 2 -  developed a head-cold to a sinus infection symptoms: swollen glands, mucous and coughing up phlegm, still fatigued,  arm is still numb and tingling but lesser so.  Reported reaction to Dr. on 6/30/21.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient passed out. Patient was responded to immediately. Blood pressure was checked and 911 was called. EMS evaluated patient and determined that the patient is okay.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 immunisation.     No Medical History information was reported.    On 15-Apr-2021 at 1:45 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 15-Apr-2021 at 1:45 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 58.18 years. No concomitant medications were reported. Batch number 044B21A  underwent temperature excursion on 15-Apr-2021 with temperature 34 degrees Fahrenheit at 09:00 AM. The vial was initially moved to the fridge on 06-Apr-2021 and proposed beyond use date was 09-May-2021. Product moved to clinic on 15-Apr-2021. 18 vials were sent to clinic. Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a traceable temperature monitor at every hour. No treatment medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).
Fever, chills, migraine, sleepiness, stomachache, flulike symptoms, could not lift left arm, very sore arm, achiness, headache.
Discharge Provider: MD Primary Care Provider: MD Admission Date: 4/5/2023 Discharge Date: 4/10/23   PRESENTING PROBLEM: Acute on chronic respiratory failure [J96.20] Acute respiratory failure with hypoxia [J96.01] Tracheostomy complication, unspecified complication type [J95.00] Acute on chronic respiratory failure with hypoxia [J96.21]   HOSPITAL COURSE: 74-year-old male with complex medical history including AFib, ulcerative colitis, CVA, PE/DVT, and coronary artery disease who was admitted to the intensive care unit from LTACH on 04/05/2023 after having worsening hypoxemia and secretions.  The patient was admitted in January, 2023 to hospital for rectal bleeding.  The patient was also found to have inferior wall STEMI complicated by cardiogenic shock and respiratory failure requiring intubation/extubation, pneumonia, PE and DVT.  The patient was transferred to Hospital for IVC filter placement as he had GI bleeding with heparin drip.  The patient was transferred rehab and then was admitted to different Hospital on 02/21/2023 for fecal impaction and was found to have stroke.  The patient was then discharged to inpatient rehab on 02/24/2023.  At the rehab the patient was found to have AFib with RVR and was transferred back to Hospital.  The patient developed VT arrest requiring CPR and intubation.  He was found to have severe multivessel disease not amenable for PCI/CABG on 03/03/2023.  Trach was placed on 03/22/2023 and the patient was transferred to LTACH on 03/27/2023 for trach management.  At LTACH, on 04/04/2023 trach was decannulated.  However on 04/05/2023, the patient had worsening hypoxemia and secretions.  The patient was also found to have COVID 19. The patient was admitted to the intensive care unit for trach replacement.  ENT was consulted and replace trach.  The patient was given remdesivir and Decadron for COVID 19 infection. The patient needs a 3 day critical airway watch prior to return to LTACH. Cardiology was consulted.  The patient was transferred out of the intensive care unit to the hospitalist service on 04/06/2023. He had a trach exchange again to smaller size on 4/7 by pulmonology team. He did well after this. Seen by SLP who again recommended strict NPO and tried speaking valve but stated not currently ready for speaking valve during eval. He was discharged to acute rehab in stable conditions.
Adverse event: Pain, Inflammation, redness, warm to touch, tender Treatment: Course of antibiotics Outcomes: patient is doing much better
Shortly after receiving the Moderna COVID-19 vaccine, patient complained of chest and stomach pain, then became very sleepy and fainted. RN was unable to obtain a manual BP; Apical pulse 36.  Pulse Ox in the 70s. She was placed in bed and eventually regained consciousness.  Her pulse ox improved to the 90s.  BP 92/55.  Her only complaint was that her hands were cold.  Medical Director believes it was vasovagal syncopy due to receiving the vaccine.  Patient died on 1/28/2021, due to progressive dementia.
190 patients (9 different lot numbers) received a vaccine past the beyond used by date; No Adverse Event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No Adverse Event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received 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 EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date).    This case was created for 153rd of the 190 patients involved. Concomitant medication was not provided. It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 Vaccine. Treatment information was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-704335 (Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704335:Master case
I was diagnosed with adhesive capsulitis (frozen right shoulder), hypothyroidism, and chronic lymphocytic leukemia (CLL) after receiving Anthrax Vaccination #3 and Japanese Encephalitis Virus Vaccine #2 simultaneously on 5/6/2016 in the right shoulder. The injection site and surrounding tissues were very sore for 5-7 days. Shortly afterwards, the range of motion of my right shoulder decreased significantly and I began to experience pain in the right shoulder at night. Later, after significant follow up and blood tests, I was also diagnosed with hypothyroidism and CLL. I believe that some or all of these conditions were caused by the simultaneous administration of Anthrax Vaccination #3 and Japanese Encephalitis Virus Vaccine #2.
Systemic: Fainting / Unresponsive-Severe, Systemic: Hypotension-Severe, Systemic: Vomiting-Medium, Additional Details: Syncope; normal bp; hr 80; hx of syncope from dental procedure. No hx of seizure.
Migraines for several days, nausea on day three; nausea; This is a spontaneous report from a contactable other healthcare professional, the patient.  A 51-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number: EL0140), via intramuscular route of administration in the left arm on 18Dec2020 at 09:00 (at the age of 51-years-old) as a single dose for COVID-19 vaccination.  Medical history included fibromyalgia and history of migraines. The patient did not have any known allergies to medications, food, or other products. The patient was not pregnant at the time of vaccination.  Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported; however, there were other medications the patient received within 2 weeks of the vaccination.  The patient had not received any other vaccine within 4 weeks prior to the vaccine.  On 21Dec2020 at 13:00 the patient experienced migraines for several days, nausea on day three. The patient did not receive any treatment for the events. The clinical outcome of the migraines for several days, nausea on day three was recovering.  It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Allergic reaction within 30 minutes of receiving vaccine, creating itchy rash and hives.  Following day experienced body aches, abdominal pain, chills, extreme fatigue, and severe pain in left arm where vaccine was administered. Slight swelling in left arm and inability to hold or lift things with left arm.
Adverse drug reactions (including pain) after human papillomavirus (HPV) vaccine; Adverse drug reactions (including pain) after human papillomavirus (HPV) vaccine; product origin unk; This spontaneous social media report was received from an other health professional and refers to a female patients in age between 12 to 24 years old. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On an unknown date, the patient was vaccinated with human papillomavirus (HPV) vaccine (manufacturer unknown) (dose, route of administration, lot #, expiration date were not reported) for prophylaxis. On unknown day, the patient experienced undesirable drug effects (including pain). The outcomes of the events were not reported.  The events were considered as related to human papillomavirus (HPV) vaccine (manufacturer unknown).  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2107USA008728: US-009507513-2107USA008733: US-009507513-2107USA008729: US-009507513-2107USA008732: US-009507513-2107USA008731: US-009507513-2107USA008730: US-009507513-2107USA001853:
Numbness; tingling; moderate to severe pain in right hand; It wakes me up at night, it's so bad; Visual disturbances (floaters in left eye constantly).; This is a spontaneous report from a contactable Nurse (reporting for herself). A 63-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, lot Number unknown, expiration date unknown) 2nd dose, via an unspecified route of administration administered in Arm Right 23May2021 at 12:00 pm, as single dose for covid-19 immunization (at the age of 63-years-old). The patient medical history was not reported. The patient was not patient diagnosed with COVID-19 prior to vaccination and since vaccination has not been tested positive for COVID-19. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication(s) included duloxetine hydrochloride (CYMBALTA); trazodone (TRAZODONE) and hydrocodone bitartrate, paracetamol (NORCO) all were taken for an unspecified indication and start and stop date were not reported. patient previously experienced allergy while taking codeine, Ativan and augmentin bambini. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, lot Number unknown, expiration date unknown), via an unspecified route of administration on 2May2021 at 12:00 pm, as single dose for covid-19 immunization. Caller stated that after receiving second dose of vaccine on 26May2021 08:00 am the patient experienced numbness, tingling, and moderate to severe pain in right hand. it wakes me up at night, it was so bad. visual disturbances (floaters in left eye constantly). Patient visited to the emergency room/department or urgent care for the events. The outcome of the events was not recovered.  Information lot/batch number is requested.
Administered MENACTRA B, patient had already received booster on 3-19-2015.
her arm felt weird and hot and that this did not occur w/ the first 2 vaccines she received, skin above & below injection site was warm to the touch w/ slight erythema present. Pt denied any shortness of breath, palpitations, throat itching/feeling swollen or any tongue complaints. This nurse applied 1% hydrocortisone cream to site and reset the 15 minute timer at 11:05. This nurse checked on patient to reassess after 5 minutes, with the patient in complete eye view the entire time. At this time patient states she is feeling minimally better. Injection site rechecked and erythema not present, with the arm now cool and dry. Benadryl 25mg given PO to patient at 11:12. Pts second timer completed at 11:20. At this time pt is feeling much better.
right arm swelling  immediately after injection. followed by bilateral lower leg edema, chills and body aches that continued  daily at 2 weeks post immunization admin  2/4/21 treated with  dexamethasone 6mg PO x 7 days- this resolved his s/s   2/13/21 patient passed away at facility
Information has been received from a physician concerning a 21 month old female, that was exposed to an adult who had chickenpox about 3 weeks ago, who was vaccinated with a 0.5 ml dose of varicella virus vaccine live. On 06-AUG-2005 the patient developed 11 red bumps on her abdomen, a low grade fever and a grumpy mood. It was reported that the patient was recovering. Unspecified attention was sought. No product quality complaint was involved. No other information was provided. The patient's twin sister experienced 5 red bumps on her abdomen following vaccination with varicella virus vaccine live (WAES0508USA01774). Additional information has been requested.
This spontaneous report as received from a healthcare worker refers to a 23 year old female patient who on 05-OCT-2012, was vaccinated intramuscular with 0.5 ml of GARDASIL (lot # H011350) dose 1. 28-JAN-2013, was vaccinated with GARDASIL (dose, lot # and route not provided) dose 2. No concomitant medications were reported. No adverse events reported. No further information was provided. Additional information has been requested.
This case was reported by a nurse via call center representative and described the occurrence of rash in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced rash. On an unknown date, the outcome of the rash was unknown. It was unknown if the reporter considered the rash to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. Couple of weeks after receiving SHINGRIX, the patient experienced rash. The consent for follow up was declined. The reporter declined to provide patient details or demographics for themselves.
Pain in upper arm and some in shoulder for the past 5 weeks since  booster shot.
Pfizer-BioNTech COVID-19 Vaccine EUA Swollen lymph nodes in right arm pit Started after day 5 of vaccination and at time of report is still significantly swollen.
Narrative: 11/03/21 COVID vaccine dose #1 06/16/22 Pt reports to PCP history of reaction to COVID vaccine: "muscle cramps, cont with left leg cramp, had borderline D-dimer, not sure if it meant subclinical DVT or not, but no DVE dx. Chest pain, muscle pain, muscle cramps/pain, tinnitus and hives also reported by PCP.
Area 1" redness, swelling, warmthto touch at injection site. Area painful. Resolved 10-15-15. Pain axilla 10-16-15.
Gave SQ MMR and within 5-10 min, noted 1" x 3" induration/erythema.
Swollen lymph nodes under right arm, painful to the touch, and visibly protruding from the skin (there is a visible lump). Began early in the morning, 6 days after first Moderna dose of COVID vaccine. No other symptoms or side affects of vaccine have been observed.
I have continued to have a deep burning sensation in my left upper arm - mild to moderate discomfort.  As the months have gone by the area is slightly larger. The discomfort about the same.
Pt recvd vax & 1 wk later exp pain, erythematous hives, itching & burning of hands & feet; sx reoccur on & off for 20 minutes then dissipate;
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Physician).  A 54-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) 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) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient not received other medication in 2 weeks. Patient received treatment.  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 information available, the events Drug ineffective and COVID-19 are assessed as related to BNT162B2 administration.
pt recvd vax 6NOV93 & w/in 1 hr returned to office for inject site react consisting of erythema, induration & pruritus 3 cm in diameter; treated w/DPH; pt recovered; pt has recvd flu vax in the past w/no problems;
patient had pain, swollen in arms at the injection sites, no fever, no breathing issues and no mobility issues. pt reported that she was felling better after couple of days
Has had enlarged tonsils since receiving the second dose of the Pfizer COVID-19 vaccine diagnosed multiple times by urgent care, general practitioner and EMT.  Has been tested multiple times for strep (negative) and Mono/Epstein-Barr (also negative).  Never had swollen tonsils before.  Not improving.  Will likely have to have them removed.
Rash on leg from reaction to something; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash on leg from reaction to something) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-May-2021, the patient experienced RASH (Rash on leg from reaction to something). The patient was treated with CEFALEXIN (CEPHALEXINE) ongoing since an unknown date at an unspecified dose and frequency and PREDNISONE ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, RASH (Rash on leg from reaction to something) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Company comment: Although rash is consistent with the product known safety profile base don he information provided suggesting that the rash was due to something, causal relationship with mRNA-1273 use cannot be confirmed.; Sender's Comments: Although rash is consistent with the product known safety profile base don he information provided suggesting that the rash was due to something, causal relationship with mRNA-1273 use cannot be confirmed.
on how to identify the variant she got infected with; on how to identify the variant she got infected with; This is a spontaneous report received from Pfizer sponsored program. A contactable female consumer (patient) reported via medical information team. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Unknown), via an unspecified route of administration on an unspecified date as dose 2, single, via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that She had a breakthrough case "here" and a Pfizer trial participant. She had 100% notified her research location. The patient had 2nd dose. The patient wanted to know what variant she contracted and would love to be of more help. The patient really wished she could talk to someone more about this than at her local study location who could tell her how to get information on how to identify the variant she got infected with. She was assuming it was one of the newer variants because "they" are more sneaky, or a higher viral load. The public health "here" has her sample, but she does not know if they would tell her anything. The events were reported as non-serious. The outcome of the events was unknown.  Information about lot/batch number is requested.
Information has been received from a medical assistant concerning an 18 month old male with no illness at time of vaccination who on 22-MAY-2008 at 17:15 was vaccinated subcutaneously in right anterior lateral thigh with a first dose of ZOSTAVAX in error. The patient had been back in the office several times since the event and there were no adverse experiences. The medical assistant explained that it was a case of human error. The medical assistant grabbed the wrong box out of the freezer, where both ZOSTAVAX and VARIVAX were stored. The boxes had a different appearance. She had no suggestions on how improving the packaging, etc. as the boxes already look different. It was her mistake. Additional information is not expected.
Patient says he had soreness and pain shortly after receiving the vaccination. A little redness and mild swelling around the area developed the next day. After being advised to apply ice and taking BENADRYL he says all symptoms have resolved.