chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Extreme Pain in arm which continued to escalate through the night into the following day, swelling and redness in upper arm, had chills and shaking overnight, stuffy nose, flu like feeling.  Finally felt better 04/19/2017 but still have swelling and some pain in upper arm area.   Treated with Advil and ice pack on arm.
4 x 4 cm indurated/erythematous lesion (L) deltoid.
Product: COVID 19 Treatment, brand: Paxlovid/vaccine brand: Pfizer/BioNTech.; Product: COVID 19 Treatment, brand: Paxlovid/vaccine brand: Pfizer/BioNTech.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 57-year-old male patient received BNT162b2 (BNT162B2), on 31Mar2021 as dose 1, single (Lot number: ER8734), in left arm, on 21Apr2021 as dose 2, single (Lot number: EW0171), in left arm and on 15Nov2021 as dose 3 (booster), single (Lot number: 33030BP) at the age of 56 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High cholesterol" (unspecified if ongoing), notes: Other medical history: High cholesterol, kidney stones; "kidney stones" (unspecified if ongoing), notes: Other medical history: High cholesterol, kidney stones. Concomitant medication(s) included: CRESTOR, start date: 01Jun2017, stop date: 24May2022; FISH OIL; VITAMIN D [COLECALCIFEROL]; PROBIOTIC [BIFIDOBACTERIUM LACTIS]. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 08Jun2022, outcome "not recovered" and all described as "Product: COVID 19 Treatment, brand: Paxlovid/vaccine brand: Pfizer/BioNTech.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (30May2022) Negative; (08Jun2022) positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Patient had known allergies: No.Other medical history: High cholesterol, kidney stones. Adverse event: Tested positive again on 8Jun after testing Negative on 30May. Started experiencing mild symptoms of cough, sneezing, fatigue, body aches, brain fog. Patient had other medication in 2weeks: Yes. The patient received treatment for Antiviral drug, Product: COVID 19 Treatment, Brand: Paxlovid, Treatment start date: 24May2022, Treatment stop date: 29May2022, Indication: Treatment of COVID-19.  No follow-up attempts are needed. No further information is expected.
Felt a large amount of sensation in my injection arm 1-2 minutes after shot. Started to feel faint and light-headed 3-4 minutes after shot. Passed out about 5 minutes after shot. Felt sweaty, disoriented, spacey, and nauseated shortly after coming back to consciousness. Went to hospital in an ambulance and released a couple hours later.
4:20 patient says, dizzy, "arm on fire", burning and stiff, left arm. had 102 degree fever. 11 th and 12th noted lump size of lemon at injection site, tight and painful. Whole arm burning and very hot. 13th and 14th swelling extend to below elbow with redness and burning around arm. Also lump under armpit red and sensitive. Later blisters at injection site, itching at elbow. Patient said she put ice on the same. Follow up 11/21/08, patient went to the Emergency room and was given pain medication, and the Doctor informed her that she had an allergic reaction. She was given SULFADERM x 20 days, and instructed to apply alternately heat and cold. She stated that after two weeks she was better.
On 12/05/2022, I started to experience symptoms of feeling congested. I performed an at home test, which came back positive. I contacted my PCP and he prescribed PAXLOVID for me. On 12/06/2022, I felt fatigued and sinus pressure.
arrhythmia nervosa; Ankles swollen; Areas on both legs that were bright red/swollen/tender; Areas on both legs that were bright red/swollen/tender; Areas on both legs that were bright red/swollen/tender; This spontaneous case was reported by a consumer and describes the occurrence of ARRHYTHMIA (arrhythmia nervosa) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 22-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Apr-2021, the patient experienced ARRHYTHMIA (arrhythmia nervosa) (seriousness criterion medically significant), JOINT SWELLING (Ankles swollen), ERYTHEMA (Areas on both legs that were bright red/swollen/tender), PERIPHERAL SWELLING (Areas on both legs that were bright red/swollen/tender) and TENDERNESS (Areas on both legs that were bright red/swollen/tender). At the time of the report, ARRHYTHMIA (arrhythmia nervosa), JOINT SWELLING (Ankles swollen), ERYTHEMA (Areas on both legs that were bright red/swollen/tender), PERIPHERAL SWELLING (Areas on both legs that were bright red/swollen/tender) and TENDERNESS (Areas on both legs that were bright red/swollen/tender) had not resolved.            No concomitant medications provided. Treatment included  doxycycline and prednisone.  Based on the current available information and temporal association between the use of the product and the start date of the 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 the events, a causal relationship cannot be excluded.
Information has been received concerning a female who post vaccination, experienced a temperature of 101, chills, and injection site reaction that was 4 X 4 inches, swollen and warm to touch.
Heart palpitations Severe Hives Anaphylaxis Allergic Asthma Allergic reactions to mold,cats,dogs,shell fish etc. Tried steroids treatment. Tried Xolair shots  still experiencing reactions 1 year and 5months later
c/o pain,achiness in lt arm & lt neck area;no redness,swelling,or drainage;to MD felt it was an allerg rxn to HEP B;had to go to ER 6APR96 for more pain relief & muscle relaxant;still having shoulder/neck pain
Pt passed out about 2 mins after flu shot - hit head on floor - no bleed. No witness by this writer. Attended by employee 1st BP 98/60 pulse 56. Pt conscious immediately. ? of seizure. No hx of seizures or adverse rx from prev. flu shots. 2nd BP 104/60 pulse 58. OM balance called stat. + came in about 10 min. Pt taken to hospital on stretcher - mom attending. Pt life in conscious stated. It was stated later that pt's eyes did roll back - not sure if after fall.
Her skin is itchy; She is having some kind of allergic reaction; booster; This is a spontaneous report from a contactable consumer or other non hcp reported for herself (patient). A 70-years-old female patient received third dose (BOOSTER) of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA vaccine, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had a historical vaccine of first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA vaccine, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA vaccine, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. On an unspecified date, the patient reported her skin is itchy, she is having some kind of allergic reaction, booster. Clinical course was reported as she was not sure if she had some kind of allergic reaction because her skin was itchy and wanted to know if that was a side effect. She also stated she was currently not taking Xeljanz. The clinical outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
As anticipated, the day following the shot, I felt flu-like symptoms which subsided by late evening. Monday morning, I still felt fine, but by the afternoon, complete exhaustion over took me, muscle pain and cramps began, headache returned and I've essentially been on the couch or in bed since Monday Feb 22.
pt recvd vax & exp rash, swollen nodes under arm, nausea & stiff neck on affected side;
This case was reported by a healthcare professional and described the occurrence of red area at injection site in a 15-year-old male subject who was vaccinated with FLULAVAL (GlaxoSmithKline).  Concurrent vaccinations included TDAP vaccine (unknown manufacturer) and an unknown vaccine (unknown manufacturer) both given on 16 September 2008. On 16 September 2008 at 14:20 the subject received 1st dose of FLULAVAL at 0.5 ml, subcutaneously in the right arm.  This was considered to be the wrong route of administration.  FLULAVAL should be given intramuscularly.  This was also considered to be a medication error as FLULAVAL is not indicated for use in subjects under the age of 18.  On 17 September 2008, 1 day after vaccination with FLULAVAL, the subject experienced a red area at the injection site and swelling at the injection site.  At the time of reporting the outcome of the events was unspecified.
Patient developed hives on torso area and scalp. In no apparent distress. Benadryl 0.3 ml administered.
Heart started beating really fast & then would beat really slow. I felt intense anxiety & felt like I was dying with my heart going back & forth. I had covid arm for 2 weeks, on & off again rashes all over my body that would itch.  I do not go seek treatment. I am now feeling better after the 2 week period
Anaphylaxis with facial (especially eye) swelling, discomfort in throat, blotchy erythematous rash over entire body and prolonged capillary refill. These symptoms were treated with SQ Epi and Benadryl IM.
rash/itchy/lump at injection site; at crease of elbow - rash and lump
It was reported by telephone that a 13 y.o. male PT received Imovax IM lot R0885-2 administered in the deltoid on 8/15/01. PT also received Bayrab-Rabies Immune Globulin lot #618W02A in left gluteal. PT experienced numbness and tingling from the waist to hip and down the left leg on the left side.
Red circular area that started day two. Seemed to not really grown until day 7 and has gotten bigger on day 8 and 9 and arm is sore again with a hard lump under injection site.
In early June, this person (a physician) noted a rounded skin lesion adjacent to her vaccination site.  It has in the past week grown to 5-7 mm in diameter.  It was described as pustular and firm (like an uncooked pea) to palpation, like a pimple but without any expressible material,  with slight tenderness and minimal erythema at its borders.  No treatment so far that we know of.
Information has been received from a registered nurse concerning her daughter with frequently injection site reaction after unspecified vaccination who was vaccinated with MMR II (Lot# not reported). After vaccination with MMR II, the patient experienced an injection site reaction of redness and hardness and a fever. The outcome of adverse event was unknown. It was not reported whether the patient sought medical attention. This is one of several reports receive from the same resource. Additional information has been requested.
Shoulder and arm pain, swelling for over 2 weeks after vaccination (not yet resolved)
Sore arm, red raised for a week or so after the vaccine which then turned into a golf ball sized bump on the arm which hurts at times of movement
left axillary lymphadenopathy noted on CDC website as "unsolicited adverse event"
This spontaneous report as received from a radiology technician refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 09-MAR-2016, the patient was vaccinated with an improperly stored dose of VARIVAX injection (lot# L016123, expiration date 06-MAY-2017; dose, anatomical location and route of administration were not reported). No adverse events were reported. Temperature was 10.6 degrees Fahrenheit for 9 days. The data logger was involved and there was no previous temperature excursion reported. This is one of several reports received from the same reporter. Additional information has been requested.
Have medium pain; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Men B NVS (Bexsero) 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 30th March 2021, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. In March 2021, less than a week after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced pain. On an unknown date, the outcome of the pain was not recovered/not resolved.   It was unknown if the reporter considered the pain 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 were provided as follows: Age at vaccination was not reported. The patient received Bexsero yesterday from the date of reporting and had medium pain as side effect. The reporter wanted to know was it safe to take for pain reduction as tylenol or ibuprofen.
Initial information received on 09-Oct-2018 regarding an unsolicited valid non-serious case received from a consumer. This case involves two-year old female patient who received 0.5 mL dose of FLUZONE QUADRIVALENT (batch number UI996AB, expiry date 30 June 2019) in right thigh on 09 Oct 2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to overdose. It was unknown if any adverse event occurred. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in 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. Documents held by sender: none.
Dizziness, balance, pressure in head, confusion, given dizzy medicine, then antibiotics for ear infection, then sent to neurologist for further testing
vertigo; dizziness; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (vertigo) and DIZZINESS (dizziness) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VERTIGO (vertigo) (seriousness criterion hospitalization) and DIZZINESS (dizziness) (seriousness criterion hospitalization). At the time of the report, VERTIGO (vertigo) and DIZZINESS (dizziness) outcome was unknown.      No concomitant and treatment information were reported by the reporter.  Company Comment: This case concerns a patient of unknown age and gender with no reported medical history, who experienced the unexpected  serious events of Vertigo and Dizziness. The events occurred an unknown number of days after the second dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a patient of unknown age and gender with no reported medical history, who experienced the unexpected  serious events of Vertigo and Dizziness. The events occurred an unknown number of days after the second dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
big welt; injection site is red and itchy; injection site is red and itchy; swelling in the arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE URTICARIA (big welt), VACCINATION SITE PRURITUS (injection site is red and itchy), VACCINATION SITE ERYTHEMA (injection site is red and itchy) and VACCINATION SITE SWELLING (swelling in the arm) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A21A and 038A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Mar-2021, the patient experienced VACCINATION SITE URTICARIA (big welt), VACCINATION SITE PRURITUS (injection site is red and itchy), VACCINATION SITE ERYTHEMA (injection site is red and itchy) and VACCINATION SITE SWELLING (swelling in the arm). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form and CORTISONE at a dose of 1 dosage form. At the time of the report, VACCINATION SITE URTICARIA (big welt), VACCINATION SITE PRURITUS (injection site is red and itchy), VACCINATION SITE ERYTHEMA (injection site is red and itchy) and VACCINATION SITE SWELLING (swelling in the arm) outcome was unknown.            The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event was not applicable. Concomitant drug was not reported. Treatment  included antibacterial cream.   Most recent FOLLOW-UP information incorporated above includes: On 14-May-2021: Follow up received on 14-MAY-2021 and does not contain any new information
pt recieved his smallpox vaccination in the right arm and it was covered with an occlusive dressing. Approx. 48 hours later he noticed a vaccinia lesion on his left arm that then progressed through the same stages as the vaccination site. He stated he had never removed the originally applied dressing at the time he discovered the lesion on the left arm
11 year old was administered PEDIARIX; Wrong vaccine administered; extra dose administered; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 11-year-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number B4722, expiry date 17th February 2024) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 15th April 2022, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On 15th April 2022, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration, wrong vaccine administered and extra dose administered. On an unknown date, the outcome of the inappropriate age at vaccine administration, wrong vaccine administered and extra dose administered were 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: 15-APR-2022 Reporter's Comments: Reporter was office manager and medical assistant. The reporter reported that a 11 year old patient received a dose of Pediarix on the day of reporting. No other symptoms were reported.  The patient received Pediarix instead of the patient's Tdap dose.  The patient was up to date on their IPV and Hepatitis B vaccination series.  The administration of Pediarix was the patient's 5th dose of Hepatitis B. The reporter consented to follow up. Patient's initials were unavailable at the reporting time. Additional Supportive Information: The pharmacist stated that a 11 year old patient received an Pediarix dose instead of Tdap, which led to inappropriate age at vaccine administration and wrong vaccine administered. The administration of Pediarix was the patient's 5th dose of Hepatitis B, which led to extra dose administered. Per package insert Pediarix was approved as a 3 dose series for 6 weeks of age through 6 years of age. This case is linked with case US2022060303 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022060303:Same reporter
Injection site pain, redness. Patient has skin peel from elbow to shoulder (described like a bad sunburn).  Also had a rash on arms and severe itching on scalp
Atypical Measles-- MMR given 8/19/2002                    Measles diagnosed 8/30/2002
After receiving the vaccine and within 2 days I felt tired and had muscle aches. My arm was sore where the shot was given. Around 4/16/2021 I got a terrible head cold, congestion, sinus pressure, headache and plugged up ears. This lasted about 2 weeks. Then got sick again with same symptoms on 8/2/2021 for about 2 weeks.  Then got sick again on 12/27/2021 with the same symptoms for about 2 weeks.  Sick again on 2/23/2022 same symptoms for about 10 days. I am usually a very healthy person and never get this sick so many times.  Makes me think it's from the vaccine but not sure and just wanted to inform you of the history of illnesses.
Abdominal pain began late Sunday (04/04/2010) and progressively became worse until it became severe in the early morning hours of Thursday, 04/08/2010.  Went to the ER and was given a diagnosis of pancreatitis of unknown origin (patient does not drink alcohol and had no signs of gallbladder disease)
really uncomfortable, my stomach is alarming; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received BNT162B2 (COVID Vaccine, manufacturer not clarified), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. Medical history included hypertension, diabetes, atrial fibrillation. The patient had some concomitant medications. When probed for any concomitant, patient stated, that was her other concern. She was seeing there was an issue with if you won't blood thinner (further not clarified). Patient stated, she got her own injection (COVID Vaccine) on Friday and It was not been major but she had been to the bathroom since Friday and she was change her diet or anything. This was really uncomfortable, her stomach was alarming. Patient asked if that was normal. Outcome of the event was not reported.   Pfizer is a marketing authorization holder of COVID Vaccine in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of COVID Vaccine has submitted the same report to the regulatory authorities.  Information on the lot/batch number has been requested.