chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pain, tenderness at injection site, soreness; Redness at injection site; Swelling at injection site; Bump in arm, 3 bumps beneath the skin; This case was reported by a nurse via sales rep and described the occurrence of injection site pain in a 20-year-old female patient who received Men B NVS (Bexsero) (batch number ABX987AZ, expiry date 1st January 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 14th July 2021, the patient received the 1st dose of Bexsero .5 ml and Bexsero Pre-Filled Syringe Device. On 20th July 2021, 6 days after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced injection site pain, injection site erythema, injection site swelling and induration. The patient was treated with non-drug therapy (Cold Compress). On 20th July 2021, the outcome of the injection site pain, injection site erythema and injection site swelling were recovered/resolved. On an unknown date, the outcome of the induration was not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, injection site erythema, injection site swelling and induration to be related to Bexsero and Bexsero Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details provided were as follows: The patient received a dose of Bexsero in left arm and post 6 days of vaccination, patient experienced pain, tenderness and redness at injection site.Redness at injection site was resolved. Patient was told to put ice on injection site, no medications were prescribed or recommended. The patient stated that there were 3 bumps beneath the skin.The bumps were still present but had decreased in size.  The patient cancelled appointment for 2nd Bexsero dose. Four weeks later (date unknown), when patient went to get her flu shot in right arm as per pharmacist suggestion. Pharmacist also recommended to contact her health care professional regarding the bumps. Health care professional called GSK and asked if 2nd dose Bexsero was contraindicated. Patient was interested in completing Bexsero series but would not if contraindicated. The health care professional had not seen the patient since July visit and has not seen the bumps. Health care professional also stated she will examine the patient when she comes in for the 2nd dose of Bexsero.
Mild erythema noted around injection site. Child c/o mild itching. Informed by nurse who administered vaccine to follow-up with their medical doctor if symptoms worsen. Informed of local reactions after vaccines.
allergies; scratchy throat; positive for Covid; This is a spontaneous report from a contactable consumer via a Pfizer-sponsored program COVAX US Support. This consumer reported similar events for 2 patients. This is one of the 2 reports.  A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 04Feb2021 (Batch/Lot number was not reported) as 1st dose, single for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter stated that she and her husband received 1st shot on 04Feb2021. On an unspecified date, the patient (husband) had scratchy throat and assumed it was from allergies. Then 4 days later they both tested positive for Covid. The patient had a Covid-test on 08Feb2021 with positive result. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021294455 Same reporter, drug, and event, different patient
Heart Palpations-May 05, 2021 Tinnitus=May 11, 2021 Hearing Loss Right Ear-May 11, 2021 Spots on Brain--September 26, 2021 Paresthesia-September 28, 2021 Photophobia and Phonopobia--September 15, 2021 Neuropathy- October 2, 2021 Brain Fog- May 4, 2021 Small Vessel Disease-September 26, 2021 Headaches-April 29, 2021
chills, fever, malaise, pain and swelling at injection site. Redness and warm to the touch at injection site. Fever up to 103.0 degrees.  Patient reported being prescribed Cephalexin.  Some resolution of symptoms started Sunday afternoon and progressively better on Monday.
during 15 minutes observation patient experienced dizziness and nausea and  dry heaves.  Waited an additional 30-45 minutes.
Small red bumps, one slightly vesicular at site of varicella vaccine - occurred night after IZ, "worse" day by day.
Narrative: The patient received two doses of Pfizer vaccine in Feb/Mar 2021. The patient tested positive for COVID 19 on 29 December 2021. The patient was admitted to the hospital due to a fall, but discovered the patient with sepsis and COVID pneumonia diagnosed on 31 Dec 21. The patient was treated with dexamethasone and remdesivir. The patient is still in the hospital as of 10 Jan 22.
intestinal infection; severe abdominal pains; nausea; diarrhea; vomiting; intestinal infection or blockage; booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50 year-old patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 06Nov2021 09:30 (Lot number: 30145BA) at the age of 50 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "High Blood pressure", start date: Jul2014 (ongoing); "Depression", start date: Aug2018 (ongoing); "diverticulosis/ internal hem", start date: Jan2016 (ongoing); "anxiety", start date: Aug2018 (ongoing). Concomitant medication(s) included: VALSARTAN HYDROCHLOROTHIAZIDE AKRIKHIN taken for blood pressure abnormal (ongoing); BUPROPION HCL ER taken for depression, anxiety (ongoing); DESVENLAFAXINE SUCCINATE MONOHYDRATE taken for depression, anxiety (ongoing). Vaccination history included: Bnt162b2 (DOSE 1,Time: 04:00 PM, Batch/Lot number: ER8737,Anatomical Site of injection:  left arm,Route of administration: intramuscular), administration date: 01Mar2021, for COVID-19 immunization, reaction(s): "intestinal blockage", "severe constipation"; Bnt162b2 (DOSE 2,Time: 01:00 PM, Batch/Lot number: ER8736,Anatomical Site of injection:  left arm, Route of administration: intramuscular), administration date: 21Apr2021, for COVID-19 immunization, reaction(s): "severe constipation", "inappropriate schedule of vaccine administered". Prior vaccine in four weeks was None. After each dose of the vaccine the patient experienced severe constipation requiring a rectal enema for relief. it is especially important to note that after the 3rd Dose the patient experienced severe abdominal pains, nausea ,diarrhea and vomiting. This event required an urgent care trip where the patient was given a Course of antibiotics and told that the patient most likely had an intestinal infection and / or blockage. The patient have a follow up colonoscopy scheduled for January. The following information was reported: IMMUNISATION (medically significant) with onset 06Nov2021, outcome "unknown", described as "booster"; GASTROINTESTINAL INFECTION (medically significant), outcome "unknown", described as "intestinal infection"; ABDOMINAL PAIN (medically significant), outcome "unknown", described as "severe abdominal pains"; INTESTINAL OBSTRUCTION (medically significant) with onset 12Nov2021, outcome "recovering", described as "intestinal infection or blockage"; NAUSEA (non-serious), outcome "unknown", described as "nausea"; DIARRHOEA (non-serious), outcome "unknown", described as "diarrhea"; VOMITING (non-serious), outcome "unknown", described as "vomiting". The event "intestinal infection or blockage" was evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: blood pressure abnormal: (Jul2014) high; colonoscopy: (2016) unknown results. Therapeutic measures were taken (Rectal enema, antibiotics) as a result of gastrointestinal infection, intestinal obstruction.
local reaction of pain at the ID administration site; local reaction of redness at the ID administration site; local reaction that was warm to the touch; intradermal administration of Td instead of PPD; On 10/22/2019 a 21-year-old female mistakenly received an ID injection of MassBiologics' Td (Lot #A102B1) in her right lower forearm instead of a PPD administration; the dose administered was 0.1mL and not the 0.5mL labeled Td dose.  On the same day the patient also received Sanofi Pasteur's Tdap vaccine (Lot #U6214AA) via IM injection in her right deltoid.  The error was found on 10/23/2019 at which time the reporter called the patient reschedule the PPD.  During the call the patient reported redness and pain at the ID administration site.  That same day, the patient returned to the healthcare facility to receive PPD injection and examination of wrong drug reaction.  The patient presented in the office with a local reaction of redness that was warm to the touch at the lower right forearm location where Td was incorrectly administered.  The patient was not treated for the reaction.  The patient returned to the medical facility on 10/25/2019 but there was no record of her Td reaction and the healthcare provider indicated that they had no plans for additional follow up with the patient.  The medical facility also indicated that the wrong drug administration was due to human error.; Sender's Comments: This medication error was assessed as non-serious.  The Td vaccine was administered in error instead of PPD.
Anxiety, tiredness, muscle pain, headache, nausea, fatigue, numbness of the hands and rash at injection site.
received the first dose around 10:00 AM and after his arm hurt for a couple days.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (received the first dose around 10:00 AM and after his arm hurt for a couple days.) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0021321A, 002B21A) 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) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced VACCINATION SITE PAIN (received the first dose around 10:00 AM and after his arm hurt for a couple days.). On 19-Mar-2021, VACCINATION SITE PAIN (received the first dose around 10:00 AM and after his arm hurt for a couple days.) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by investigator  No treatment medications provided by the reporter.   This case was linked to MOD-2021-080394 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: Added reporter details and outcome of the event arm hurt is recovered. On 23-Jul-2021: follow-up received on 22-jul-2021 contains no new information On 10-Aug-2021: follow-up received on 10-Aug-2021: Event stop date updated.
Hives, swelling of the throat and neck area, a fast heartbeat, dizziness and general weakness.
Patient started having Gran mal siezures consistently at 2..first one at 1 year old..placed on Tegretol till he was 5 yes old. He's had multiple neurological problems..eyes went crooked at 6 months had surgery to correct them at 2, tonsils and adenoids were enlarged taken out at 2, began having tinitus at 2, which has caused his nerve deafness and is now legally deaf. Diagnosed with Asperger Autism at about 4-5..
Pain in muscles around injection site, pain in lymph node under shoulder, pain, soreness and tightness in muscles in neck in right side, pain in right shoulder
On Monday in the afternoon I had a cold, seasonal allergies, congestion and a very stuffy head. I wore a nasal strip to get relief but when I got up Tuesday, I took multiple test and they were all possible. I reached out to my doctor and had an appointment where the provider had me do a PCR test which was also positive. I was advised to quarantine, rest and hydrate. I am still symptomatic. Today was the worse I have felt.
No PQC or additional AEs reported.; 20yo patient received RECOMBIVAX 5mcg dose; This spontaneous report was received from a medical assistant referring to a 20 years old patient of unknown gender. The patient's concurrent condition, pertinent medical history, concomitant medication, drug reactions or allergies were not reported.  On 15-JUL-2021, the patient received hepatitis b vaccine (recombinant) (RECOMBIVAX HB) (strength: 5 micrograms, dose: 0.5 milliliter, lot # T022800, expiration date: 19-NOV-2022) intramuscularly for prophylaxis (inappropriate dose of vaccine administered). No additional adverse events reported.  combinationproductreport: Yes; brandname: RECOMBIVAX HB SYRINGE (DEVICE); commondevicename: Hepatitis B Vaccine (Recombinant); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername:  devicelotnumber: T022800; expirationdate: 19-NOV-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
C/o Dizziness/ Headache ? Initial BP 89/62 ? 103/75
During a routine exam, discovered that ususal hypothyroidism switched to hyperthyroidism. Changed prescription and will revisit in Sept.
fourth shot gave a rash around injection site; got huge patches on abdomen; itchy; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE: 01, Route of Admin: Intramuscular), administration date: 20Feb2021, when the patient was 52-year-old, for COVID-19 immunization, reaction(s): "Autoimmune disorder", "Drug allergy", "Injection site itching", "Injection site reaction"; BNT162b2 (DOSE: 02, Route of Admin: Intramuscular), administration date: 13Mar2021, when the patient was 52-year-old, for COVID-19 immunization, reaction(s): "Autoimmune disorder", "Drug allergy", "Injection site itching", "Injection site reaction"; Astrazeneca covid-19 vaccine (DOSE: 03 (Booster dose), Route of Admin: Intramuscular), for COVID-19 Immunization. The following information was reported: VACCINATION SITE RASH (non-serious), outcome "unknown", described as "fourth shot gave a rash around injection site"; MACULE (non-serious), outcome "unknown", described as "got huge patches on abdomen"; PRURITUS (non-serious), outcome "unknown", described as "itchy".  Additional information: The patient had two Covid-19 injections, and said injections threw her into an autoimmune disorder. The physician prescribed HUMIRA. She was injecting into abdomen. She had an allergic reaction to HUMIRA. Her first three shots went fine; the fourth shot gave her a rash around injection site. After the fourth injection, she got huge patches on her abdomen, they were itchy, and each injection made it worse and worse. Patient then had two AstraZeneca injections simultaneously without any side effects. Patient was prescribed RINVOQ at the time of report. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Primary reporter did not have the lot number information, because the packaging was discarded.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
72 hours post vaccine injections was admitted to the hospital after ER visit.  Diagnosis of "GLOBAL TRANSIENT AMNESIA".    was given pfeizer biovalent covid vaccine at same time of flue injection.
Sore arm; Headache; Fatigue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Sore arm), HEADACHE (Headache) and FATIGUE (Fatigue) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), HEADACHE (Headache) and FATIGUE (Fatigue). On 11-Jan-2021, PAIN IN EXTREMITY (Sore arm), HEADACHE (Headache) and FATIGUE (Fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment for the event included Zofran and Ketorolac.  Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
We have some Moderna Covid-019 vaccine that was given after the expiration date.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We have some Moderna Covid-019 vaccine that was given after the expiration date.) in a 74-year-old patient of an unknown gender who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 091D21A) for COVID-19 vaccination.     No Medical History information was reported.    In October 2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. In October 2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (We have some Moderna Covid-019 vaccine that was given after the expiration date.). In October 2021, EXPIRED PRODUCT ADMINISTERED (We have some Moderna Covid-019 vaccine that was given after the expiration date.) had resolved.        For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments.   Date of administration of vaccine was between 24Oct2021 - 27Oct2021.  No concomitant information was reported.  No treatment information was reported.
Client called 10-25-12 c/o soreness and redness in arm where received Tdap vaccine. States is beginning to get better but still has soreness & redness.
Pt reported large red spot, slightly raised, warm to the touch with light itching. She also reported hot/cold sweats and a low grade temperature of 99 deg F. Symptoms appeared on 10/22/17 with the vaccination given on 10/20/2017.
Early morning of 03/19/2023 my symptoms were drainage and coughing. 03/20/2023, my symptoms became worse, I got a headache, lethargic, a lot of coughing, and shortness of breath, a lot of drainage and settled into what I would describe as bronchitis. My symptoms prompted me to do a COVID-19 Home Test and the result was positive. I talked to my doctor on 03/23/2023. I described my symptoms, and he asked me questions about those symptoms. The doctor prescribed the Paxlovid, but by the time I was able to pick it up it was beyond the 5-day period, so I did not take it. I took Tylenol and Nighttime Cough Syrups, Robitussin and Zicam over the period of time.  I tested Negative on 03/25/2023 with a COVID-19. My symptoms lasted about 14 days.
Within 1 hour of injection (10:00am), began experiencing fatigue that got increasingly worse. By 2:00pm, had slurred speech; severe fatigue; red skin on hands, face, neck; balance problems and dizziness; swollen hands. That evening through the next morning, I was experienced severe flu-like symptoms, including vertigo, extremely severe fatigue, and full-body muscle aches. My temperature was slightly elevated (98.7) from my "baseline," which is around 96.7. On Saturday, I was very tired, no appetite, still experiencing some vertigo and muscle aches. Symptoms improved overnight and by Sunday evening, I was mostly back to normal, with some lingering fatigue.
I have had shingles 5 times and had this vaccination at MD's request.  My arm has severely itched for 3 days and yesterday I started to experience pain in the side that I had shingles (rib pain)  Is this a reported side effect?
Dizziness start on Sunday,  3/21/2021 and has been present every day since so far. This is abnormal for me. Prior to that, I have been having some problems breathing after getting the vaccine and have been using my Ventolin  more often after the vaccine. Also noticed shortly after getting the vaccine, a feeling of liquid in my right ear.  the liquid in the ear did go away a day before the dizziness started.  Did not consider the ear or breathing issues as possible side effects  as I do have asthma and figured the ear was congestion. Not sure if the dizziness and the feeling of liquid in my right ear are related and/or related to the vaccine.
Warm at injection side (left arm); Cough; Chills; Nausea; Sore muscles; Headache; Med Info Agent: Got call from customer care and case number is  MOD2021-005990. Caller stated that he received a voicemail from moderna agent that they need the caller's email address to update and the caller provided the email address. provided updated email address.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
L leg swollen, warm to touch, fever, from knee upward. ER 6/2/01 reaction Tx, 6/3/01 Cefzil, PMD 6/4/01 kept on Cefzil.
Pfizer covid-19 shot full adult dose was given to patient under 12. Mother did not report any adverse events out of ordinary associated with the shot given. Due to another appointment, it was noticed that the date of birth was changed on the card which would put the patient at under 12 when they received the primary seires. Was noted the date of birth was different on previous forms but changed this time per other pharmacy.
Rash covering chest, neck and face. Also swelling of face and around eyes. Started on 4/14 was still present when I visited doctor on 4/23 and was placed on Benadryl.  Finally started going away 4/25. Still have rash and swelling if Benadryl wears off