chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt had a near syncopal episode after injection. Ringing in ears, pale, shaky, light headed. We lied pt down, BP was 90/60 then increased to 110/70 with rest and a snack.
Fever, Severe Headache, chills, Severe Aches throughout body, No Energy, Lethargic, No Appetite, Slept 18 out of 24 hours, Severe Sweating
Pain in large area where shot administered, red rash that increased in size over 5 day period, fever ranging from 99.6 to 102.2. Received prescription of doxycycline hyclate 100 mg, Tylenol, advil and warm and cold compresses.
Information has been received from a registered nurse referring to multiple unspecified patients of unknown age and gender. On unknown dates, the patients were vaccinated with unspecified number of improperly stored GARDASIL 9, (dose and route not provided) (lot number # L019286, expiration date: 14-NOV-2017 or lot number # L011846, expiration date 16-JUN-2017). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Patient came in for a flu shot with other family members who were receiving a Moderna Booster of 0.25ml. A technician gave the patient a dose of Moderna 0.25ml IM instead of FLuarix.  Technician immediately realized error, reported to pharmacist (myself) and I informed the parents of the patient and advised them to monitor their daughter for any adverse reaction and to delay giving the flu shot for at least two weeks. I told them we would be reporting this to VAERS, and contact their family physician as well. I also said I would contact Moderna to report the error and obtain further information on what the outcome might be.
(R) upper arm red, warm, swollen 12 hrs after injection. (+) pruritis, nontender approx. 6 cm x 4 cm tx-BENADRYL, AUGMENTIN
having trouble breathing; chest tightness; headache; A spontaneous report (United States) was received from a consumer concerning a 58-years-old patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events having trouble breathing/dyspnoea, chest tightness/chest discomfort, and headache.  The patient's medical history included Type 2 Diabetes. Concomitant product use was not provided by the reporter  On 10 Mar 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (Batch: 030A21A) in the left non-dominant arm for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the events trouble breathing, chest tightness, headache. Treatment for the event included Tylenol.  Action taken with mRNA-1273 in response to the events was not provided.   The outcome of events, having trouble breathing, chest tightness, and headache was not provided.; Reporter'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. Further information has been requested.
Employee received flu vaccine and approx. 30 minutes later presented with swollen tongue, wheezing, & shortness of breath.
Describes rash over trunk and legs.  Describes rash as small dots that look like ant bites.  One or two on arms  no treatment needed.  Slight itching but resolved by itself.
Date of start of drug: 26Dec2020, Dose Number: 1 /Date of start of drug: 12Jan2021, Dose Number: 2; Rash on right breast and then all over trunk.; Diagnosed with pityriasis rosea; This is a spontaneous report from a contactable other health care professional. A 32-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Right on 12Jan2021 (Batch/Lot Number: EL1283) as SINGLE DOSE for COVID-19 immunisation. Concomitant medication included piroxicam (PAXIL [PIROXICAM]), gabapentin (GABAPENTIN), medroxyprogesterone acetate (DEPO-PROVERA). The patient experienced date of start of drug: 26dec2020, dose number: 1 /date of start of drug: 12jan2021, dose number: 2, rash on right breast and then all over trunk on 21Jan2021, diagnosed with pityriasis rosea on 21Jan2021. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 26Jan2021 Roche cobas 6800, sars-cov-2 test: negative on 04Feb2021 Roche cobas 6800. Therapeutic measures were taken because of rash on right breast and then all over trunk. (rash), diagnosed with pityriasis rosea (pityriasis rosea). The outcome of the event Inappropriate schedule of vaccine administered was unknown and outcome of other events was recovering.
63 years old male patient was given Fluzone High Dose Quadrivalent by mistake because he looks older than he is/ no adverse event; 63 years old male patient was given Fluzone High Dose Quadrivalent by mistake because he looks older than he is/ no adverse event; Initial information received on 14-Oct-2020 regarding an unsolicited valid non-serious case received from a nurse manager via Health Authority (Reference number- 00316083).  This case involved a 63 years old male patient who was vaccinated with 0.7 ml single dose vial of QUADRIVALENT INFLUENZA VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (batch number UJ500AA and expiry date: 30-Jun-2021) via intramuscular route in left deltoid administration site on 14-Oct-2020 for prophylactic vaccination (product administered to patient of inappropriate age and overdose).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was a case of actual medication error due to inappropriate age at vaccine administration and overdose (latency was on same day).   At the time of reporting, patient had no adverse event.  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.
Incident occurred from possible inviable covid-19 pfizer-purple dose (booster) being administered to the patient. Patient reported no adverse events other than typical ones from covid vaccine. Patient will consider the offer for a replacement booster dose.
7 days after first dose of vaccine I began to have mild itching around the injection site in my left arm. On the 8th day after my vaccine I woke to a very itchy vaccination site on my arm surrounded by a red rash. The rash is at this time not solid but patchy and slightly raised. I have been using Motrin and Benadryl ointment, both seem to be helping however area does appear to be increasing .
No taste for a month; No smell for a month; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (No taste for a month) and ANOSMIA (No smell for a month) in a 61-year-old male patient 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced AGEUSIA (No taste for a month) and ANOSMIA (No smell for a month). At the time of the report, AGEUSIA (No taste for a month) and ANOSMIA (No smell for a month) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  Treatment information was not provided.
Low grade fever, aches & chills on 3/13/21 & 3/14/21.  Felt better 3/15/21 through 3/18/21.  Side effects ( fever, aches, chills ) returned on 3/19/21 & 3/20/21.  Suffered stroke on 3/21/21 at 3:30 AM due to blood clots.  Passed away on 3/22/21.
bone pain; chills; fever; headache pain; This spontaneous case was reported by a consumer and describes the occurrence of BONE PAIN (bone pain), CHILLS (chills), PYREXIA (fever) and HEADACHE (headache pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-2021, the patient experienced BONE PAIN (bone pain), CHILLS (chills), PYREXIA (fever) and HEADACHE (headache pain). At the time of the report, BONE PAIN (bone pain), CHILLS (chills), PYREXIA (fever) and HEADACHE (headache pain) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided.  Treatment medications was not given.   This case was linked to US-MODERNATX, INC.-MOD-2021-107093 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-107093:
COVID-19 mRNA LNP-S, bivalent PF 6mos-5yrs (Moderna), 10 mcg/0.2 mL (Wrong dose given- under dosed).
Paralysis on (R) side of face - Bell's Palsy. 12/02/09 Medical records received for DOS 11/07/09, 11/30/09. Pt presents with running nose, body aches, ear pain and requests H1N1 vaccine.  Three weeks later  presents with facial paralysis on right side of face. Referred to neurologist.
She put the shot in the wrong place so that hurt very bad  but almost right away it got red, hot, could not move my arm for 3 days. Fever, stomach pain, shivers, next day could not do anything. Redness grew and hurt so bad. Whole arm was numb for a week. Severe headaches neck shoulder back pain. Went to urgent care and I have cellulitis in my arm. Started antibiotics and going to dr on monday.  Still arm pain, headaches  tired. Shoulder neck and  back pain. Very very scared that it has spread. I have swollen gland on left side. And just do not feel good at all. Using heat pad all he time. Also ice at times.
Right eye began burning in outside half aprox 20 minutes after injection (felt like I was poked hard in the eye). It has continued to burn since, and waters constantly. Little and temporary relief with eye drops after an initial and intense burning.   At approximately 10 pm, my resting heart are spiked to 90+ BMP and my respiratory rate increased. My blood pressure spiked to 187/142 (normally around 118/76 area). I practiced mindfulness breathing and my heart rate fluctuated from high 80?s to 100. I fell asleep and my hear monitor showed a sustained resting (sleeping) heart rate between 88-92 (10-12 am), 80-91 (12-1 am), 66-81 (1-2 am), 68-75 (2-3 am), and 70-76 (3 to 4 am, awake).  My normal resting heart rate is 61 and the range of my heart beat for the 28th was 58-172 with no physical activity (outside of short walking to/from pharmacy for vaccination and inside my home).  Periodically, my chest will hurt and fells like my heart skipped a beat if that makes sense, and takes my breath away.   My left eye continues to burn.
Received flu shot from unknown location, arm pain immediately with persistent pain at 3 weeks out from vaccine, some radicular pain.
Pain and restricted movement in his left arm; Pain and restricted movement in his left arm; This is a spontaneous report from a contactable other hcp (patient).  A 53-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular, administered in Arm Left on 21Jan2021 12:00 as DOSE 1, SINGLE for covid-19 immunisation. Facility type vaccine was Workplace clinic. The patient medical history and concomitant medications were not reported. No other vaccine in four weeks. The patient experienced Pain and restricted movement in his left arm on 21Jan2021 at 12:00. AE resulted In Disability or permanent damage. The outcome was Not recovered. AE treatment included Pain medication. No covid prior vaccination. Covid tested post vaccination. Covid test post vaccination (Nasal Swab, name: Colo) on 02Feb2021 with unknown results.  Information on the lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine can not be excluded for the reported events of pain and restricted movement in his left arm  due to temporal relationship.  Case will be re-assessed upon the additional information provided. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
pt recvd vax; 9 hrs later, pt became very lethargic,pale,blue,weakly arrousable, rectal t 97.0; remained very lethargic, sleepy x 4 hrs then returned to nl status; pt now well on exam;
Fever (102) for a period of 4 days, muscle and body aches, sore throat, headaches.
pt to ED with generalized weakness, increasing SOB, abdominal pain, body aches, fever, nausea; found to be positive for influenza B and COVID; AKI; given Tamiflu, ABX, IV fluids, Heparin; DNR/DNI; experienced ventricular tachycardia with varying arrhythmias; quickly became unresponsive; comfort care; pt passed away in the hospital
Patient called 10/12/2009 complaining his arm was painful especially if rotate arm.
Tested positive for COVID 12 days after second booster, on 6/29/2022, though symptoms began one day prior. Do not know if infection related to vaccine or not. Symptoms were body aches, chills, heavy congestion, and sleeplessness for about 3 days. Sore muscles have persisted through now, 7/5/2022 (although hard to tell whether soreness simply due to being isolated and sedentary for extended period).
11 YEAR OLD RECEIVED ADULT LOT # AND DOSE FOR SECOND DOSE PFIZER. UNDERAGED.
Information has been received through a pregnancy registry from a 31 year old female patient with no past medical history who on 7/1/04 was vaccinated with a first 0.5ml dose of varicella virus vaccine live. There was no concomitant medication. The patient stated she had the shot and became pregnant that same week. Subsequently, in July 2004, the patient developed a slight rash on her back and face. Unspecified medical attention was sought. The physician was not sure if the rash was from the varicella or because of her first time pregnancy. Treatment was not required and laboratory tests were not performed. The patient noted therapy with varicella virus vaccine live was discontinued. A product quality complaint was not involved. Follow up information indicated that the child was due in April 2005 (reported as 2004). Additional information has been requested.
This spontaneous report as received from a 66 years old diabetic female registered nurse (also the patient) with drug reaction/allergy to CIPRO, quinine, sulfa and to THEO-DUR refers to herself. She was vaccinated subcutaneously with a 0.65 ml dose of live ZOSTAVAX (lot number not reported) on 22-JAN-2013. No other co-suspects were reported. No concomitant medications were given. On 23-JAN-2013 the patient experienced blisters, warm to touch, and they have spread down her arm. She contacted with the physician. She received steroid injection (route unspecified) as a treatment. No lab diagnostics studies were performed. The outcome of blisters, warm to touch, and they have spread down her arm was reported as recovering/resolving. The relatedness for blisters, warm to touch, and they have spread down her arm was not reported for live ZOSTAVAX. Additional information has been requested.
Itching, redness, heat at injection site.  In second day. Shot was 8 days ago.
This case was reported by a healthcare professional and described the occurrence of expired vaccine used in a subject of unspecified age and gender who was vaccinated with TWINRIX, (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of TWINRIX (1 ml, unknown details) and expired vaccine used. The expiry of TWINRIX was 3 November 2013. The immunization series was not discontinued or delayed and symptoms did not recur following subsequent administration. No adverse events were reported. The reporter documented another case of expired vaccine used. See case A1059914A for details on the other case.
Periorbital cellulitis a few days after getting vaccine. Her sister also developed periorbital cellulitis a year earlier within 2 weeks or receiving her second HPV vaccine.
arm is sore; hurt it Burns like crazy; hurt it Burns like crazy; Initial information received on 17-Oct-2020 regarding an unsolicited valid non-serious social media case from a consumer (patient).  This case involved a 75 year old patient (unknown gender) who reported that arm is sore (Pain in extremity) and hurt it burns like crazy (Pain and Burning sensation), while the patient received Influenza Vaccine.  The patient's medical history, past medical treatment(s), vaccination(s), family history and concomitant medications were not provided.   On an unknown date, the patient received an unknown dose of suspect influenza vaccine produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, reported that arm is sore (Pain in extremity) and hurt it burns like crazy (Pain and Burning sensation) (Unknown latency) following the administration of influenza vaccine.  No laboratory test was reported.  It was not reported if the patient received any corrective treatment.  The event outcome was reported as unknown for all the events, at the time of reporting.  There will be no information available on the batch number for this case.
Pregnant; This case was received via call centre on 19-Mar-2021 and was forwarded to Moderna on 19-Mar-2021.    This spontaneous pregnancy case was reported by a consumer and describes the occurrence of PREGNANCY (Pregnant) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced PREGNANCY (Pregnant). At the time of the report, PREGNANCY (Pregnant) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Diagnosed and hospitalized while fully vaccinated including a booster shot administered 9/23/2021
pt devel fever & generalized sz activity 24hr p/vax;required ER visit w/transport by paramedics;required tx w/med;
Pt had tongue and throat numbness , lightheaded, dizzy, throat swelling and possible early anaphylaxis and went to ER
Received bivalent booster 09/17/2022 and did not report at time of vaccination. Vaccine administered 11/17/2022 was second bivalent booster received in total. Patient was notified and reported no side effects. Instructed to report any concerns and seek medical attention if necessary.
headache; fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old male patient received bnt162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), on 04Oct2023 at 08:00 as dose 1, single (Batch/Lot number: unknown) at the age of 39 years, in left arm for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), on 04Oct2023 as dose number unknown, single (Batch/Lot number: unknown), in right arm. The patient's relevant medical history included: "Currently have a herniated spinal disc between L5-S1" (unspecified if ongoing). Concomitant medication(s) included: GABAPENTIN. The following information was reported: PYREXIA (non-serious) with onset 04Oct2023 at 21:00, outcome "recovering", described as "fever"; HEADACHE (non-serious) with onset 04Oct2023 at 21:00, outcome "recovering". Therapeutic measures were taken as a result of headache, pyrexia.  Additional information: The patient developed a headache and fever overnight (day of the vaccine into the next day). He took OTC ibuprofen. Known allergies: Kaflex causes a skin rash.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
headache, fever, chills, swelling in shoulder of same side of injection site, feeling unwell,  lump in shoulder, body aches, elevated temperature
This spontaneous report was received from a physician via company representatives referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 16-OCT-2014, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 0.5 mL (VIs 10 SDV) (Lot # K007822, expiration date 15-AUG-2015) single dose, route and anatomical location were not provided. There was no concomitant medication provided. No adverse effects were reported. On an unknown date, the PNEUMOVAX had a temperature excursion for 40 and 72 hours, the lowest recorded temperature was 28F (-2.222Celsius) and the highest was 47F (8.333 Celsius). The vaccine status was reported as "in excursion", the storage criteria and the vaccine excursion were reported as "Refrigerator (R)". There was no product quality complaint involved. This is one of several cases received from the same reporter. Additional information has been requested.
Eight days after receding the vaccine, I woke up with an itchy rash near the inject site. It was a lopsided oval that was swollen, red, hot, and itchy. The redness slowly faded for 3 days, along with the other symptoms. The redness faded significantly in 24 hrs but left a ring of red, only the outside of the oval.
Headache, Myalgia, Arthralgia, arm discomfort Narrative:
Had bad headache and slight fever from 6pm-1am starting March 6 after vaccination. I was very fatigued. I had to take an Advil as I had no Tylenol. On March 9, I had a slight cough and shortness of breath. On March felt a shortness of breath and cough  still.
Vacine at 4 p,m, Monday Feb. 24.  By 6pm, extreme soreness and stiffens in arm.  By 7 pm unable to move left arm due to pain at 7-8 on a 10 scale.  Uncontrollable shaking, shivering, headache, it felt like a medical emergency.   Called nurse advice line.  Told symptoms could continue for 3 days.   By 9 pm shaking and shivering reduced, but still extreme pain in left arm, unable to move it due to pain.   Took ibuprofen before bed.  Unable to sleep.  4 am still can't move arm due to pain..  Headache, body aches, chills all day, no food.  By 4 pm pain in arm reduced to 4, able to move it gently.  Still have headache, body chills, aches.  Called Dr. nurse for note from doctor about returning to work Friday- was hassled  by her nurse on the phone about why so long from work, completely insensitive to my pain and experience, said it wasn't typical and sounded like she didn't believe me.  Given the extreme side effects I felt I wanted to be prepared in case it did last 3 days.
Mild Itching and redness at injection site began on Day Six at about 6pm, AFTER answering texting check-in questions at 4pm.  Next day (today, Day Seven after injection) the itching and redness have increased with the reddened area being the size of a silver dollar with slight heat and slight swelling.
I had an amplification within all my normal aches and pains. I had increased depression which has caused me to now be on antidepressants. This is ongoing.