chrisvoncsefalvay/vaers-outcomes huggingface dataset:
upper lip tingling; left side of face from forehead to chin, including eye, tingling/ left and right cheeks tingling; swollen vaccine site; unable to lift arm; Lower lip numb and Lip numbness on both lower and upper lips/ upper lip moderately numb; left side of face from forehead to chin, including eye, numb/ chin numb; burning; sharp pain in lower lip; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204 COA) via an unspecified route of administration in the right arm on 13Mar2021 at 10:00 (at the age of 57-year-old) as a single dose for COVID-19 immunisation. Medical history included 2007 lyme's disease, but no symptoms since 2007. The patient had known allergy to codeine. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) started on an unknown date for unspecified indication, loratadine (CLARITIN) started on an unknown date for unspecified indication and multivitamin (MANUFACTURER UNKNOWN) started on an unknown date for unspecified indication. Prior to the vaccination, the patient was not tested positive for COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 13Mar2021, hours after vaccination, the patient experienced burning and sharp pain in lower lip.  On 14Mar2021, the patient experienced swollen vaccine site, unable to lift arm, lower lip and chin completely numb. On 15Mar2021, the patient experienced left side of face from forehead to chin, including eye, tingling and numb, lip numbness on both lower and upper lips. On 30Mar2021, the patient experienced left and right cheeks, upper lip tingling and moderately numb and reduction in numbness to just lower lip and chin, from 22- 29 March, reduced to lower lip numbness only. No therapeutic measures were taken as a result of the reported events. The events resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the events burning, sharp pain in lower lip, swollen vaccine site, unable to lift arm, chin completely numb left side of face from forehead to chin, including eye, tingling and numb, lip numbness on upper lips, moderately numb, left and right cheeks, upper lip tingling was recovering  and lower lip numb was not recovered at the time of this report.     No follow-up attempts are needed. No further information is expected.
Diarrhea , weakness, sharp pain on back left flank, needles in pelvis and extremities, cold extremities, headache, disoriented
This spontaneous report as received from two pharmacists refers to a patient of unknown age and gender. On 28-FEB-2014, the patient was vaccinated with a dose of improperly stored ZOSTAVAX, lot # J007854, expiration date 28-SEP-2014 (dose and route not reported) that was exposed to 38F for 576 hours, dates of excursions: 01-FEB-2014 to 28-FEB-2014. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Prostate cancer diagnosis 07Sep2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old male patient received BNT162b2 (BNT162B2), on 08Mar2021 as dose 2, single (Lot number: EN6204) at the age of 65 years intramuscular, in left deltoid for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose1, single, Anatomical site of injection: Left Deltoid, Route of administration: Intramuscular, Batch/Lot number: EL9266), administration date: 13Feb2021, when the patient was 65-year-old, for COVID-19 immunization, reaction(s): "Following Paxlovid I tested negative". The following information was reported: PROSTATE CANCER (medically significant) with onset 07Sep2021, outcome "recovered" (05Jan2022), described as "Prostate cancer diagnosis 07Sep2021". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (30Jul2022) Negative; (01Aug2022) Negative; (02Aug2022) Negative; (04Aug2022) Positive, notes: COVID Rebound Positive Test; (07Aug2022) Negative; (08Aug2022) Negative; (11Aug2022) Negative; (12Aug2022) Negative; (15Aug2022) Negative; (21Jul2022) Positive, notes: Positive COVID, Home Test; (22Jul2022) Positive, notes: Positive COVID, Clinic Test. Therapeutic measures were taken as a result of prostate cancer. Patient had Radical prostatectomy. Clinical course: No Prior Vaccinations (within 4 weeks). Patient received BNT162b2 on 30Aug2021 as dose3, single (Lot number: 301308A) and on 14Apr2022 as dose4, single (Lot number FP4554) via intramuscular, in left deltoid for covid-19 immunisation. Paxlovid administration date was 22Jul2022.
The patient's arm is swollen, inflammed and quite warm. The patient was treated with Decadron, Depo Medrol and Levaquin.
See patient's account of the event below. Patient is not an established patient and did not receive care for her symptoms at our facility:  On March 18th I received my 2nd Moderna vaccination. On Friday the 19th at approximately 4 pm I began to have the symptoms of an immune response in my body. Sat the 20th was spent in bed with chills, body aches, fever, stiff neck, and bad headache. On Sunday I was having pain on inhalation along with everything else.  Monday the pain resolved into left side lung pain on inhalation. Tuesday the 23rd I called my provider who directed me to go to the Emergency Dept. I drove to Superior Hospital. After being accessed I was transported; with pericarditis and the additional mentioned immune response symptoms, and a pronounced heart murmur. On Wednesday the 24 I shook uncontrollably with chills for 4 hours and 2 min and went into atrial fib for about 12 minutes, resolved with medication.  Thursday the 25th I woke to all symptoms being gone. I was released on Friday the 26th with the statement my issues had resolved themselves. I was told to report this to where I got my vaccine so it could be passed along.
LITTLE MORE ENERGETIC; RESTLESS; This spontaneous report received from a consumer concerned an 84 year old female. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025, expiry: UNKNOWN) dose was not reported, administered on 21-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced little more energetic, and restless. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the little more energetic and restless was not reported. This report was non-serious.
04/18/21 - arm pain, mild stomach upset, mild nausea 04/19/21 - severe arm pain, general malaise, generalize stomach upset, nausea 04/20/21 - measles-like rash in torso beginning at neck ending at waistline.  Neck area rash coalesced into red patches, skin slightly raised.  Burning-like feeling on rash areas. Mild headache. Arm pain resolved. Nausea and stomach upset resolved. 04/21/21 - Continuing rash, no further spread.  Dizziness, feeling faint. Return of stomach upset and nausea afterwards.  Tiredness, fatigue, headache.
Pt rec'd ADACEL inj. (L) arm 6/24/15. Pt developed swelling, bruising, redness, pruritus on (L) upper arm. Pt. went to see Dr 7/1/15 started on MEDROL dose pack and triamcinolone cream BID.
Fatigue, nausea, slight fever, body aches.  Lasted about 12 hours.  Symptoms started almost exactly 24 hours after 2nd dose.  Woke up the next morning feeling fine.
On 08/11/21 at approx 10 pm patient started having a 104.0 temp. Thursday and Friday . Friday night 08/13/21 he started feeling  what he describes as ?brain fog?.   Patient continues to complain of ?brain fog,? and ?I feel like my head is in the clouds,? that has not resolved since receiving his second covid vaccine dose. Was having headaches shortly after for a few days and I took him to the emergency department  on 08/192021. He had a brain CT and had basic labs drawn. We doctor dc?d him home with a diagnosis of headache, and told us to follow up with his  pediatrician. We are waiting to schedule that appointment this week.  The ?brain fog,? has not gone away since 08/13/2021?
Pt received PPV23 on 5/2 Pt stopped by clinic later same day. Below site swollen 4" long x 3" wide, redden, warm to touch, very itchy, severe pain, hives on arm, neck and face itchy. Trx = Ice to area QID x 2-3 days and BENADRYL.
Hives all over my body. Hives were worsening for the first 3 days following vaccination. oral steroids prescribed.
pale red blotchy; poking at the injection site; the site turned red; the injection site became hot to touch; half moon shape swelling; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included shoulder arthritis.   On 21st February 2020, the patient received the 1st dose of Shingrix. In February 2020, less than a week after receiving Shingrix, the patient experienced injection site warmth and swelling. On 21st February 2020, the patient experienced injection site erythema. On 29th February 2020, the patient experienced injection site reaction. On 1st March 2020, the patient experienced injection site rash. On 1st March 2020, the outcome of the injection site reaction was recovered/resolved. On an unknown date, the outcome of the injection site erythema, injection site warmth and injection site rash were recovering/resolving and the outcome of the swelling was recovered/resolved.   It was unknown if the reporter considered the injection site erythema, injection site warmth, swelling, injection site reaction and injection site rash to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The patient received vaccine in her left arm and that same day the site turned red, a two to three inches perfectly round red area. The reaction got worse for the next seven days, the injection site became hot to touch, and developed a half moon shape swelling half inch belowthe red area. On 28 and 29th February 2020, the reaction was at its worse. On 29th February 2020, 8 days after vaccination, the patient also started feeling something poking inside and out at the injection site, it occurred like a wave, intermittently throughout the night but resolved the next day. On 1st March 2020, 9 days after vaccination, the site was pale red blotchy looking, and the half-moon swelling has resolved. The patient received steroid injections on left shoulder. The reporter consented to follow up. Provided caller with side effects information from PI. Referred caller to her physician regarding taking over the counter medication before taking her second Shingrix injections.
Member noticed swelling in upper right arm with sensation of swollen fingers right hand w/in N 6 deg of injection. Presents today with 24 hr post injection with swollen warm, reddened area of upper right arm.
patient received 3 doses of Shingrix; This non-serious case was reported by a physician via sales rep and described the occurrence of extra dose administered in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an  unknown date) and Shingrix (2nd dose received on an  unknown date).   On an unknown date, the patient received the 3rd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: patient received 3 doses of Shingrix). The outcome of the extra dose administered was unknown.   Additional Information: GSK receipt date: 20-APR-2023 The sales representative submitted the following via system for a physician that if a patient received 3 doses of Shingrix, what should be done and was there anything that they should look out for? The reporter consented to follow up with sales representative for more information. The patient received 3 doses of Shingrix, which led to extra dose administered.
This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nausea) and MALAISE (does not feel well) 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 06-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NAUSEA (Nausea) and MALAISE (does not feel well). At the time of the report, NAUSEA (Nausea) and MALAISE (does not feel well) had not resolved.            No treatment or concomitant medications were reported.
Sudden infant death. Family visiting relatives found baby unresponsive in crib.  6/13/08 Autopsy report states COD as SIDS.  Report states patient traveled with family out of state over holiday w/e.  Placed in portable crib for nap.  Found unresponsive & cool approx 3 hrs later.  CPR started & EMS called but no pulse or respirations.
Clear fluid leaked out after patient received the vaccine/t's possible that patient received the partial dose; A spontaneous report was received from a pharmacist concerning a male patient of unspecified age, who received Moderna's COVID-19 vaccine (mRNA-1273) and its clear fluid leaked out after patient received the vaccine/it's possible that patient received the partial dose.  No relevant medical history and concomitant medications were provided.   On an unspecified date, the patient received their first of two planned doses of mRNA-1273 (lot number unknown) intramuscularly for prophylaxis of COVID-19 infection.   On an unknown date, pharmacist stated that, the vaccinator noted a clear fluid leaking out after patient receiving the vaccine and also stated that it was possible that the patient had received a partial dose. The patient didn't have any other symptoms. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The event, clear fluid leaked out after patient received the vaccine/it's possible that patient received the partial dose was considered to be resolved on an unspecified date.; Reporter's Comments: This report refers to a case of incorrect dose administered for mRNA-1273.  There were no reported adverse events associated with this case.
Following vax pt had t104 w/2min febrile seizure; no treatment required; temp down spontaneously; No further problem;
Patient complaint of pain in left shoulder and inability to move arm, same day after vaccine given 1/29/2021. Pt reported she couldn't perform activities of daily life. she requested Physical Therapy referral in Feb 2021 which help but pain was not getting better. April 1, 2021 Patient had a left shoulder MRI which showed Left RC tendon and tendonitis as well as a tear noted in MRI.
Dose 1,2,3 are Moderna vaccine and Dose 4 is Pfizer vaccine; he now has COVID; he now has COVID; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 47-year-old male patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 19Mar2021 as dose 1, single (Lot number: 037A21B), on 22Apr2021 as dose 2, single (Lot number: 043B21A) and on 29Dec2021 as dose 3 (booster), single (Lot number: 033H21A), all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "blood pressure high" (unspecified if ongoing), notes: blood pressure is high. Concomitant medication(s) included: AMLODIPINE taken for hypertension. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 17Jan2023 at 07:30, outcome "unknown" and all described as "he now has COVID"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "Dose 1,2,3 are Moderna vaccine and Dose 4 is Pfizer vaccine".  Clinical course: Patient developed COVID at 7:30 am this morning, 17Jan2023. When his blood pressure is high and has taken the pill twice in the last 2 weeks. Comirnaty, Pfizer-BioNTech COVID-19 Vaccine [Monovalent] and/or Bivalent Dose/Dosage Form: Gray cap, Original (Monovalent), greater than or equal to 12 years - 30 mcg/dose, Do not dilute.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Morbilliform rash, with in 2 weeks of MMR Vax, rash at injection site and then from the face down.
Drop in blood pressure on the day of vaccination, hives and swollen face/eyes several days after the vaccine, headache and weakness for several days after injection.  Resolved after about a week.
AT 5:00PM ON DAY OF VACCINE ADMINISTRATION, HAD HEADACHE AND FELT WARM. AT 7:00PM, HEADACHE AND BODY TEMPERATURE INCREASED. 01:00AM NEXT DAY, VOMITING AND 'TEETH CHATTERING' CHILLS. ALSO HAD SORE ARM, NAUSEA, DIZZINESS, LOSS OF APPETITE.
Patient felt light headed and dizzy. Patients father lowered patient to the ground. Cold pack applied to neck, feet elevated, and orange juice given to patient. Had patient remain on floor for five minutes. After five minutes, had patient stand slowly. Patient felt better and left without any other incident.
Follow up information providing adverse events and recovery status was received from the reporter. Information regarding Prevnar (pneumococcal 7-valent conjugate vaccine (diphtheria crml97 protein) injection) was received from a healthcare professional regarding a 5 month old male patient who was inadvertently given Prevnar  SQ in the RA and experienced mild redness and swelling at the injection site. The pt received a second dose of Act Hib (Aventis) (haemophilus b conjugate vaccine (tetanus)), the second dose of polio vaccine (Aventis) (poliomyelitis vaccine inactivated) and the second dose of diphtheria/tetanus toxoids/ acellular pertussis vaccine (Aventis) on 04/12/2004. Event Details: The pt was inadvertently given a dose of Prevnar SQ in his right arm. The pt experienced mild swelling and redness at the injection site which resolved in 2 days.
Child received shots on 8/8/01. Denied adverse reactions or complications after previous shots. Noted left deltoid area to be red in color, warm and firm to touch, 2 days, post vax. Brought child to health dept immediately after observing this reaction. Explained to staff, that child also received 4 wasp stings the same evening of shots, but not in upper left arm. She did give Benadryl for wasp stings. Instructed her to repeat Benadryl and apply ice. Report to physician if becomes worse.
Began experiencing severe sinus congestion. Used OTC sinus decongestant to aid in sleeping, still experiencing congestion.
Was very whiny very unlike him. Did not want to eat said that did not feel good - Next morning was pale, light headed, dizzy. On 3 instances people offered to help him do his work which is very out of the norm. He tried to eat bananas and food to feel better. Finally got home on 9/23 by 6 PM and said that while on the truck with AC felt OK but felt like falling down with no AC. He has been taking his blood pressure medication. Today feels fine.
A month after receiving vaccination I noticed that cycles were becoming much heavier. In March of 2022 my cycles were still heavy and I was extremely fatigued so I asked OB/GYN to run labs. OB/GYN ordered lab work and PROZAC. PROZAC offered no relief and made me very sick. After the lab work returned it was determined that I was anemic and iron deficient. Was referred to an internist and functional OB/GYN. More lab work was run and it was determined that several of my hormones were out of normal limits. I was given iron infusions and multiple prescription hormones to improve where I was deficient. Feeling much better after starting all of the doctors recommendations.
Initial information received on 12-Nov-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case is linked to 2018SA315975, 2018SA315981, 2018SA315982 and 2018SA315983 (same reporter). This case involves an eight-year-old male patient who was vaccinated with 0.5 FLUZONE HIGH DOSE lot UJ000AB (expiry date: 28-Mar-2019) via unknown route in the left deltoid instead of 0.5 ml dose of FLUZONE QUADRIVALENT (Batch number, expiration date, dose and site of administration was not reported) on 18-Oct-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was an actual medication error due to wrong vaccine administered, vaccine administered at inappropriate site and overdose. It was reported that the 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. List of documents held by sender: none.
After 1st shot, I start feeling soreness in my left breast; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 25Mar2021 09:00 (Lot number: Ep7534) at the age of 57 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: AMLODIPINE; SPIRONOLACTONE. Past drug history included: Celebrex, reaction(s): "Known allergy-Celebrex". The following information was reported: BREAST PAIN (non-serious) with onset 30Mar2021, outcome "not recovered", described as "After 1st shot, I start feeling soreness in my left breast". Therapeutic measures were not taken as a result of breast pain.  Additional information: After 1st shot, patient started feeling soreness in his left breast, and after the 2nd shot an1/2" increase in size and soreness. No covid prior vaccination. No covid tested post vaccination. Facility where the most recent COVID-19 vaccine was administered: Other. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Other medical history: None.  No follow-up attempts are possible. No further information was expected.