chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Leg lumps; Still feeling bad; Woke in the mid night felt itchy right foot around the ankle/rash spread to whole body; woke in the mid night felt itchy right foot around the ankle; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (woke in the mid night felt itchy right foot around the ankle), LIMB MASS (Leg lumps), FEELING ABNORMAL (Still feeling bad) and RASH (Woke in the mid night felt itchy right foot around the ankle/rash spread to whole body) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Meniere's disease and Dizziness. Concurrent medical conditions included Blood pressure high. Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced PRURITUS (woke in the mid night felt itchy right foot around the ankle) and RASH (Woke in the mid night felt itchy right foot around the ankle/rash spread to whole body). On 13-Mar-2021, the patient experienced LIMB MASS (Leg lumps) and FEELING ABNORMAL (Still feeling bad). At the time of the report, PRURITUS (woke in the mid night felt itchy right foot around the ankle) outcome was unknown and LIMB MASS (Leg lumps), FEELING ABNORMAL (Still feeling bad) and RASH (Woke in the mid night felt itchy right foot around the ankle/rash spread to whole body) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient woke up in the mid night feeling itchy right foot around the ankle and rubbed with the rug. The itchiness went away and came back again in the morning. On 13-Mar-2021, in the morning, the rash spread to the whole body.  No treatment details were provided.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 50 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing); "obesity" (unspecified if ongoing). Concomitant medication(s) included: ENBREL, start date: Jan2019, stop date: Aug2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of covid-19.  Clinical course: Patient had no known allergies. Patient received COVID-19 vaccine previously. Paxlovid (anti-viral) treatment started on 21Jul2022 and stopped on 26Jul2022 via oral route of administration. On 31Jul2022, 5 days after completing Paxlovid began more severe coughing, malaise, no fever. Patient did not receive treatment for AE.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the known safety profile of the vaccine BNT162b2, a causal relation between the reported events Covid-19, Drug ineffective and the administration of the vaccine cannot be excluded.
5 days post TDaP patient developed fever 103-105 lasting 3 days, previous history same senerio with DTaP # and DTaP #2. 5 days post immunization fever 103-105 lasting 5-7 days. No other complaints, treated with ibuprophen and Tylenol. To ER re. fever, Dr feels vaccine relate, will f/u in office.
immed onset lt deltoid pain, radiation to lt lateral elbow, worse w/ROM better w/rest & positioning;stable w/o change over past 2mo;tx Lodine x 3 days pt quit
high blood pressure/blood pressure was sky high; she didn't feel well/not being well; dizzy; nausea; sharp pain in stomach; This is a spontaneous report from a contactable consumer (patient's daughter). An 88-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL3247), via an unspecified route of administration on 19Jan2021 at 14:00 into left arm at single dose so she wouldn't die from COVID-19, she is 88. Medical history included cancer survivor, patient had one kidney, that kidney was stage 4 kidney disease and was not on dialysis, the one kidney was kidney cancer in 2010; high blood pressure; had blood clots from 2017; heart disorder; iron was low; having problems with memory. Concomitant medications included amlodipine started taking it years ago and hydralazine both for high blood pressure, bupropion, iron started a year and a half before (in 2019) for iron was low, all ongoing; donepezil started taking it in 2011 or 2012 as memory medication, apixaban (ELIQUIS) started taking two years before (in 2019) for blood clots, isosorbide started it so many years for heart, quetiapine from 2011 for having problems with memory. The patient previously took another medicine for blood clots. The patient went to hospital for the following side effects: dizzy and nausea on 23Jan2021, sharp pain in stomach in Jan2021, high blood pressure on 24Jan2021. Reporter would like to know if this side effects were reported or what should she do for her mom. Patient had just not being well in Jan2021 after received bnt162b2. Reporter had to take her mother to the ER 24Jan2021, and right now patient was dizzy, had nausea, and reporter took her to the ER yesterday and they couldn't find anything, and reporter was trying to find: was this due to the vaccine. Patient said she didn't feel well, since Saturday (23Jan2021). Patient now had a lot of stomach pain, so reporter took patient to the ER on 24Jan2021, and did a lot of tests, and her blood pressure was sky high, reporter wondering did the vaccine affect blood pressure. Patient was just not herself, and reporter knew the patient, patient had been doing pretty good, but was not herself. Reporter stated they let patient came home from the hospital on 24Jan2021, clarified she was in the ER on 24Jan2021, was not admitted to hospital. The outcome of event nausea was not recovered, outcome of the other events was unknown.
The vaccine was administred at 2:45. In one hour, patient experienced pain in that arm; numbness at injection site and down to her finger tips. There was no discoloration. she couldn't move her fingertips for two hours. Two hours after the injection, her nose felt swollen, though this symptom couldn't be visually verified. She states that it was difficult for her to pass air through her nostrils. Patient saw urgent care. 11/15/2001 3:30 pm states reaction to Hep. B vaccine. 11/16/2001 Patient saw her M.D., who prescribed steroid & antihistamine for treatment. Two hours after treatment-no change was noted.
Patient said that she had some swelling and the area was red and warm to the touch. No other symptoms were reported.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 67-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 05May2023 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 67 years, in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: CRESTOR, start date: 01Dec2020, stop date: 04Oct2023; PROZAC, start date: 02Sep2017, stop date: 03Oct2023. Past drug history included: Sulfonylurea, reaction(s): "Drug Allergier:sulfonylurea". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received COVID-19 antiviral treatment with Paxlovid form 04Oct2023 to 09Oct2023, The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to drug ineffectiveness and COVID-19 cannot be ruled out. Events are considered related conservatively. Case will be reassessed upon receipt of additional information.
Approx 25 to 30 vesicles over face and body onset 2 days ago. No fever. No other complaint.
Severe swollwn face and lips, slurred speech and red hives all across the body. Mild breathing difficulty. Had to call 911 and was taken to the hospital
The nurse told me they would be giving my daughter 8 shots. Then another nurse came in and told me that they had 4 shots with 2 vaccines in each. The amount was due to the fact that she was behind. After they gave her the shots by the next day her legs were extremely swollen for about 5-6 days also with red blotches that protruded. The shots were given on 8-24-07 and she still has a big knot in one of her legs. My husband also called the office upset because they gave her so many shots at once and they told him that she really only had 7 shots. Her shot record says 8. Know we don't know what the truth is. What do we do know? I believe that she had 8 because two different people told me that day.
Red, pruritus skin to upper right arm at injection site (deltoid) and midway down upper arm.  Area often welts and mild swelling is noted to upper arm intermittently.
6/14/2011, 16:00:  severe pain in right arm 6/14/2011, 18:00 to 6/16/2011 at 06:00:  severe pain in right arm, muscle pain in both legs, nausea, headache, chills (flu-like symptoms),  fever between 99.6 and 100.6 with an ear thermometer.  Treatment: I went home from work early on 06/15/2011 and went to bed.  No other treatment. 06/16/2011 06:00 to 9:30am (the time now): moderate to severe pain in right arm, limited range of motion in right arm, fever of 99.1, general malaise.  Other symptoms have subsided.
I went to camp on 6/26/22.  Developed post-nasal drip on 6/28/22 which got worse by the 30th.  Developed a sore throat and took a home test.  Took a second test at health lodge at camp and came up negative.  Tested positive and had a tele-health appointment on 7/3/22 and received prescription for malnupraveer.  Started anti-virals on 7/5/22 and finished on 7/9/22.  Tested negative on 7/10/22.
1st shot: fatigue, arm pain, and left armpit pain (duration: a day) 2nd shot: (24 hrs. after shot - duration 2 days) headache, body ache, sore jaw, swollen chest and armpits, gastroinestinal issues, achey joints  2 weeks to the day after 2nd shot: sore, swollen, tender breasts and armpits; next day: mammogram resulting in injury to swollen lymph nodes that were an unknown reaction to the vaccine. It has been over a week now, and doctors are telling me this is going to be a process. I have been to the ER, and have had multiple tests ordered for imaging, but I am awaiting pre-authorization from insurance company. I am a teacher and doubt I will be physically able to return to work this school year.
Pain; Muscle aches; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain) and MYALGIA (Muscle aches) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes and Liver cirrhosis.   On 10-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Feb-2021, the patient experienced PAIN (Pain) and MYALGIA (Muscle aches). At the time of the report, PAIN (Pain) and MYALGIA (Muscle aches) outcome was unknown.            No concomitant medications were provided. No treatment information was provided.   This case was linked to MOD-2021-301000 (Patient Link).
Information has been received on 12-MAR-2019 regarding a case in litigation from a lawyer concerning a female patient of unknown age. There was no information provided regarding the patient's concurrent conditions, medical history or concomitant medications. The patient was prescribed the ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. In 2014, the patient was administered the ZOSTAVAX (lot number, expiration, dose and route unknown) by a healthcare provider at a county health department. On an unknown date, the patient was treated by a physician at a physician's office for the following injuries resulting from the patient's ZOSTAVAX use: shingles. The patient claims damages as a result of injury to self and economic losses. The outcome of the event was unknown. The causality of the event was considered to be related. Additional information has been requested.
On 6/13/00, the pt experienced itching on the top of head, left ear and neck.  The pt experienced an irregular rash on chest, stomach and back. The pt called the local ER and was advised to take Benadryl. Pt took the Benadryl and by 6/14/00 the symptoms resolved.
Offender was given 2nd dose 21 days after 1st dose.  Offender denies adverse reactions.
Hands and feet were swollen; Hands now are swollen and painful/ the fingers on my right hand started to throb; The inside of my wrist hurt when I moved it.; This has continued until the present and the fingers and wrists on both hands now are swollen and painful.; This is a spontaneous report from a contactable consumer (patient). A 74-year-old non pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number: EN6205 and expiration dates were not reported), via unspecified route of administration in the left arm on 07Mar2021 at 16:00 (at the age of 74-years-old) as dose 2, single for COVID-19 immunization. Medical history included Asthma, from an unknown start date and unknown if ongoing. The patient had no known allergies. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number: EL9267 and expiration dates were not reported), via unspecified route of administration in the left arm on 14Feb2021 at 16:00 (at the age of 74-years-old) as dose 1, single for COVID-19 immunization. On 23Mar2021, the patient experienced hands and feet were swollen, Hands now are swollen and painful/ the fingers on her right hand started to throb, the inside of her wrist hurt when she moved it, This has continued until the present and the fingers and wrists on both hands now are swollen and painful. The patient underwent lab tests and procedures which included sars-cov-2 test negative on 22Apr2021 (nasal swab). The event resulted in doctor or other health care professional visit. Treatment drugs included prednisone 40 mg for 5 days and gabapentin. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received unspecified medication within two weeks of vaccination. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. Since the vaccination, the patient had been tested for COVID-19. The clinical outcome of the events was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Patient was not feeling well with diarrhea and fatigue past 24 hours. After vaccination, patient went to observation area where they felt fatigue, sweating, and clammy. Patient alerted nurse they were not feeling well,  and nurse noted patient was breathing fine. No rapid response was called, however patient was sent over to ED with wheelchair. Patient appears stable, but is being worked up in ED now.
Fever 101.9; severe headache; muscle aches; joint pain; weakness; brain fog; lethargy; nausea; This is a spontaneous report from a contactable nurse (patient). A 73-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 04Feb2021 at 10:30 at single dose in right arm for COVID-19 immunisation at the age of 73-year-old. Lot number was EM9810. The patient was not pregnant at the time of vaccination. Medical history included asthma, psoriasis, psoriatic arthritis, cardiac arrhythmia. Past drug history included allergy to Tetracycline. Concomitant medications included metaprolol, montelukast sodium (SINGULAR), simethicone (PEPSID), clonixin lysinate (SKELAXIN), Vitamin D. On 04Feb2021, the patient experienced fever 101.9, severe headache, muscle aches, joint pain, weakness, brain fog, lethargy, nausea. Fever and headache continue 9 days after the injection. On 11Feb2021, Covid test at one week was negative (nasal swab). The patient was treated with Tylenol.  The patient did not recover from the events. Prior to vaccination, the patient was not diagnosed with COVID-19; since the vaccination, the patient has been tested for COVID-19.
This 12-month-old, with a upper respiratory infection at the time of vax, experienced two swollen, infected, suppurative lymph nodes and a fever of 101 degrees F eight days post vax. It was noted that the pt had two extractions form the lymph node. Follow-up was received from a medical assistant. On 04/10/2000, cultures of the area revealed heavy growth of methicillin resistant staphylococcus aureus. She was treated with vancomycin for 10 days. She was also treated with Augmentin and Zithromax, then with Augmentin, Tylenol, and Motrin. Subsequently, the pt recovered and was discharged from the hospital after ten days. The reporter noted informed mom probably causal relationship: doubt to secondary to varicella virus vax live. No further information is available.
Within 12 hours aching soreness in right arm extending to shoulder and back. Headache and general malaise. Within 48 hours I developed an allergic rash with blotchy red patches, over the truck of my body, sides of neck, and upper thighs.
Pt. reported extremely sore arm and hand, she said her "shoulder bone" felt broken. This has lasted 3 weeks since her immunization.
Delayed reaction occurred 8 hrs. after receiving vaccine. Felt as if I was injected with the Flu, based on the symptoms that arose: chills, fatigue, nausea, dizziness, fever, body aches, weakness, no appetite or desire to hydrate(every single symptom was severe) These symptoms lasted 12 hrs. I chose to go in to work, instead of taking the day off. I truly believe that because I pushed my body through this painful ordeal, it helped me to overcome this Flu-like feeling that I endured for 12 hours: 10 of those at my job. I also experienced a swelling & pain in my right knee. The pain & swelling is finally subsiding as I type this report 4 days after the vaccine.
Clammy, dizzy, nauseas, left arm pain and numb throat.  She was monitored on exam table and she rested and was given Benadryl and Claritin and started to feel better by 45-60 minutes.  By 2 hours she was completely normal and cleared to leave.
chest pain; severe headaches; SI joint pain; swollen lymph nodes; panic attacks; glucose levels fluctuating; This is a spontaneous report from a contactable healthcare professional reported for herself. A 39-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number and Expiration date was not reported) via an unspecified route of administration on 18May2021 at 16:15 (at the age of 39-years-old) as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunisation. Patient was not pregnant at the time of vaccination. Medical history was not reported. The patient did not receive any medication within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced chest pain, Sacroiliac (SI) joint pain, severe headaches, swollen lymph nodes, panic attacks and glucose levels were fluctuating on unspecified date in 2021. The patient underwent lab tests and procedures which included blood glucose: fluctuating on unspecified date in 2021. The events resulted in a visit to the doctors 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 Augmentin and flexril. The clinical outcome of the events was recovering at the time of this report.  Information about lot/batch number will be obtained during follow-up.
inadvertently received a dose of Menveo and Bexero; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 5-year-old female patient who received Men B NVS (Bexsero) (batch number 5AR2D) for prophylaxis.   Co-suspect products included Men ACWY-CRM NVS (Menveo) (batch number AMVA902A) for prophylaxis.   On 28-JUL-2023, the patient received Bexsero and Menveo. On 28-JUL-2023, an unknown time after receiving Bexsero and Menveo, the patient experienced wrong vaccine administered (Verbatim: inadvertently received a dose of Menveo and Bexero). The outcome of the wrong vaccine administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 28-Jul-2023 Nurse stated that neither vaccine was intended to be administered.  The Vaccine Administration Facility was the same as Primary Reporter. Caller declined safety follow-up. Did not consent to follow-up. A patient inadvertently received a dose of Menveo and Bexero on the day of reporting, which led to wrong vaccine administered.
Patient came to pediatric vaccine table and was given dose of 0.2ml instead of 0.3mls of his pfizer dose. He should have been sent to the adult side but was sent to the pediatric side (presumably with the wrong sticker) and so I administered his vaccine, as I do for every patient who comes through my station, after asking the questions to his mother.
Rash; This is a spontaneous report from a non-contactable consumer or other non-health care professional reported for herself (Patient) in response to HCP letter sent in cross referenced case.    A 20-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EL3246; Expiration date was not reported), via unspecified route of administration, in arm on 28Jan2021 (at age of 20-years-old) for COVID-19 immunization. Medical history included asthma (childhood infant asthma, that she grew out of as she aged), food allergy (banana), latex allergy, sulfonamide allergy and Avaco drug allergy along with COVID-19 (before vaccination). Concomitant medications included sertraline hydrochloride (ZOLOFT) and birth controls prior to the event being reported. The patient did not receive any other vaccines around the time of Pfizer-BioNTech COVID-19 vaccine vaccination or in four weeks. Patient did not receive any recent vaccines for any other conditions prior to the event being reported. The patient did not receive any recent vaccines for SARS-CoV2 other than Pfizer-BioNTech COVID-19 vaccine prior to the event being reported. On 01Feb2021, patient experienced rash after 4 days of first vaccination. Patient was not hospitalized nor admitted to an intensive care unit. Therapeutic measures were included took 2 Benadryl internally this worked to stop worse reaction and antihistamine. The outcome of rash was reported as unknown.     Follow-up attempts are completed. No further information is expected.