chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Got extremely itchy around 6pm on 10/15/2021 continued to have hives up both arms, woke up the following morning with a huge cold sore/hive around right corner of mouth. Sunday received huge welt hive on neck and continued to have hives up both arms but then a couple boils around the wrist appeared. Taken long lasting allergy medication Claritin and then resorted to taking Benadryl. 10/21/2021 still have boils on wrist area.
Extreme headache; Nausea; Fever; Chills; Sweating; Pain in joints; Hurt to touch skin anywhere; Total loss of appetite; Could not walk without help; This is a spontaneous report from a contactable consumer, the patient. A 70-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 15Apr2021 at 17:00 (at the age of 70-year-old), as a single dose for COVID-19 immunisation. Medical history included known allergy to sulpha. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: E?8732) via an unspecified route of administration in the left arm on 26Mar2021 at 18:00 (at the age of 70-year-old), as a single dose for COVID-19 immunisation. On 16Apr2021 at 06:00, the patient experienced extreme headache, nausea, fever, chills, sweating, pain in joins, hurt to touch skin anywhere, total loss of appetite and could not walk without help. The patient also reported that, pain was worse on skin than any pain she has ever had in her life. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events extreme headache, nausea, fever, chills, sweating, pain in joins, hurt to touch skin anywhere, total loss of appetite and could not walk without help was resolved on an unknown date in Apr2021.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Extreme pain at the injection site  and upper arm the next day that lasted about a week. The pain disappeared for a couple weeks and then came back worse then the original pain.  Eventually the pain spread to my neck and left shoulder blade from tensing my muscles in reaction to the pain.
Started vomiting Sunday evening around 11:30pm. Vomiting continued until 10:00am on Monday, 3/8. Felt extremely tired with a headache all day Monday, 3/8. Woke up Tuesday, 3/9 feeling slightly tired but no other symptoms.
Swollen, red area about 1inch diameter. Zyrtec tables. Resolved in 2-3 days.
Patient reported cold sores in her mouth on 1/9/2021 and then on 1/12/21 was seen in Dr. office and diagnosed with Bells Palsy.  Patient was started on antivirals and prednisone.
1415Called to car. Relative reports pt is weak & dizzy & head lowered to chest.  Remained oriented X4, follows commands.  Pt and relative state he was nervous before vaccine. 1421- BP:104/61 HR:60 RR:16 Sats:99% pale, cool, clammy diaphoretic skin. Nauseated after 4 sips of water.  Denied CP, SOB, Difficulty breathing. Airway patent. 1425- BP:105/71 HR:70  RR: 16 Sats:99% OX4.  1430-sitting up in car.  BP:120/78 HR: 66.  States "feels better"  Denies need for call to EMS.  Denies dizziness with standing. 1432- BP: 140/75 HR:64 RR: 18.  Assisted to passenger seat. Relative to drive home.  Educated pt and family on s/s of allergic reaction, return of symptoms, SOB/CP to call 911 or go to ER.  All verbalized understanding.
No ADR, timing ERROR 2nd dose given 44 days after 1st  Narrative:  No ADR, timing ERROR, 2nd dose given 44 days after 1st
Boosted patient admitted to hospital with COVID-19 infection.   Admitted 1/20/22
4/8/2016: Vaccine: DTaP (SK 9D7CM) and Hib-PRP-OMP (Merck L038501) to right thigh; and preservative free quad influenza (SP U5387AA) and PCV13 (Pfizer L82219) to left thigh. 4/9/2016: ER LWBS bilateral leg pain, redness, swelling, refuses to walk on legs x 24 hours "since vaccinated yesterday". Temp 101.2F. 4/11/2016: called for immunization reaction - ER. 4/12/2016: ENT visit for tubes in ears (per dad mom say visit was 4/4 for 5 episodes ear infections in the last 6 months. During these episodes, he's fussy, pulls at ears, and has fevers as high as 104. Each episode resolves after antibiotic treatment, however, they often recur 6 weeks later. His father's side of the family has extensive history of ear infections requiring tubes (dad's dad, brother, grandfather). The patient also snores at night but the parents have not noticed episodes consistent with apnea. 4/13/2016: ER: agitated with generalized rash, Temp 99.9 F - providers diagnosed as viral exanthem (varicella). 4/14-18/2016: referral to office. Mom reports her son (18 months of age) began to develop mild fever and red rash to first his trunk and head-face about 4/13/2016 in which he was taken to the ER for and on 4/14 his rash now included bilateral arms and legs. The ER providers note documented this rash as generalized with small vesicles on patches of erythematous skin and being "varicelliform". Childs fever had been treated with TYLENOL with resolution. Child was acting age appropriate, happy and in no acute distress. On 4/15/2016 mom sent me picture of his reaction. Rash had not changed but was not worse and he was acting more himself. On 4/18/2016 mom advised rash was almost gone and no other issues had developed. He was acting his normal self, walking, playing, eating, etc.
I developed hives after the Moderna vaccination.  It was not immediately but about a week after.  The hives were worse on the side of the shot initially.  They began on my back and then moved to my stomach, neck, arms, and head.  They are getting worse and not better after two weeks since the vaccine.  I have not changed/introduced anything new to my body.  I have never had hives before.
This spontaneous report as received from a medical assistant via a company representative refers to a 6 month old patient of unknown gender. The patient's pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On unknown dates, the patient was vaccinated with doses of PEDVAXHIB (dose, route, lot # and expiration date were not reported). First dose of PEDVAXHIB was administered at 2 months of age, second dose administered at 4 months of age and third dose administered to the patient at 6 months of age. No adverse effect was reported. Additional information has been requested.
I got my Second dose on May 19 2021 around noon and from night I started getting slight pain on my arm and light headache and body aches ,then I took one DOLO tablet the same night and another DOLO tablet next day and I felt all ok .From Saturday mid day I started experiencing itching and did not bother much and by Saturday night Itching has increased little bit and By Sunday,rashes appeared all over my body especially it started with both arms and then both hands and then both thighs and then legs toeas and then upper back lower back and everywhere it increased
Cough; Diarrhea; sore throat; Nausea/vomiting; Nausea/vomiting; Runny nose; tested positive (+) for COVID-19; Covid19 symptoms; sore arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (sore arm), COVID-19 (Covid19 symptoms), SARS-COV-2 TEST POSITIVE (tested positive (+) for COVID-19), COUGH (Cough) and DIARRHOEA (Diarrhea) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No relevant medical history reported).    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 19-Feb-2021, the patient experienced COVID-19 (Covid19 symptoms). On 21-Feb-2021, the patient experienced SARS-COV-2 TEST POSITIVE (tested positive (+) for COVID-19). On an unknown date, the patient experienced COUGH (Cough), DIARRHOEA (Diarrhea), OROPHARYNGEAL PAIN (sore throat), RHINORRHOEA (Runny nose), VOMITING (Nausea/vomiting) and NAUSEA (Nausea/vomiting). At the time of the report, PAIN IN EXTREMITY (sore arm), COVID-19 (Covid19 symptoms), SARS-COV-2 TEST POSITIVE (tested positive (+) for COVID-19), COUGH (Cough), DIARRHOEA (Diarrhea), OROPHARYNGEAL PAIN (sore throat), RHINORRHOEA (Runny nose), VOMITING (Nausea/vomiting) and NAUSEA (Nausea/vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included intravenous infusion of Bamlanivimav.   Most recent FOLLOW-UP information incorporated above includes: On 27-May-2021: Follow up received on 27-MAY-2021, Events updated.
This spontaneous report as received from a nurse refers to her daughter who is a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were unknown. On an unknown date the patient was vaccinated with Hepatitis B vaccine (manufacturer unknown) vaccine (dose, route and lot # not reported). The reporter stated that on an unknown date, the patient had titers drawn for Hepatitis B for nursing program and result was negative for hepatitis B (Vaccination failure) despite being vaccinated for it during childhood. The outcome of event and causality assessment was not given. The patient was vaccinated with varicella vaccine (manufacturer unknown) during childhood and experienced chickenpox (Reported in MARRS # 1611USA009929) and patient also showed negative titers for rubella (manufacturer unknown) (reported in MARRS # 1611USA009930). Subsequently, the patient was vaccinated with GARDASIL and experienced adverse events (reported in MARRS # 1611USA008442). Additional information has been requested.
Patient is 11 years old but was given the Pfizer bivalent dose for patients 12 and over. No adverse events reported at this time.
Expired dose had been administered, no AE; Initial information received on 23-Aug-2021 regarding an unsolicited valid non-serious case from a nurse and physician via Media Information (under the reference 00735979).  This case involved a 2 month old male patient who was given an expired dose of HIB (PRP/T) VACCINE [ACT-HIB] (expired product administered).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   No other concomitant medication was given to the patient.  On 23-Aug-2021, the patient received a first  dose of suspect HIB (PRP/T) VACCINE (0.5 ml, once in total,  lot UJ266AA and expiration date: 05-Jun-2021) via intramuscular route in the left thigh for prophylactic vaccination.  It was an actual medication error due to expired vaccine used (same day latency).  It was reported "Nurse called to report that an expired dose of ACTHIB had been administered to a patient. The caller would like to know whether the dose is valid and if it should be repeated."  No treatment was required.  At time of reporting, it was unknown where the patient had any adverse event or not and the outcome was unknown for the reported 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 the 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.
Patient reports of itching immediately after vaccine, dizzy, feeling of flush.  Medical directive given for itching that include OTC antihistamine (Claritin). Incident Management team activated for dizziness and feeling of flush.
Patient received Bexero injection 1 month ago and still has a lump in left arm. It may have been from administration error. Where the patient was pointing was right below the deltoid muscle.
itching at the injection site; redness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (itching at the injection site) and VACCINATION SITE ERYTHEMA (redness at injection site) 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.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (itching at the injection site). In January 2021, the patient experienced VACCINATION SITE ERYTHEMA (redness at injection site). At the time of the report, VACCINATION SITE PRURITUS (itching at the injection site) had resolved and VACCINATION SITE ERYTHEMA (redness at injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.     Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.
Patient reported hives on her body and bruising at the site of injection. I spoke to her today (12-27-16) and she said the hives and bruising are vanishing.
She specified "not at the injection site", but "a general outbreak", "like acne" and "outside the skin"; This is a spontaneous case received from a contactable consumer (patient). A 69-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: not provided; Expiration date: not provided) via an unspecified route of administration on an unspecified date as dose 1, single for Covid-19 immunization. The patients medical history and concomitant medications were not reported. On an unspecified date patient specified not at the injection site, but a general outbreak, like acne and outside the skin. Patient explained she may have experienced it after the first dose and was not sure. She also mentioned she does not know if it was related to the vaccine and she will consult her Health care professional. The outcome of event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
33 Year old male received Anthrax shot experienced headache, cold sweats and soreness in upper right arm. Patient was administered Benadryl and released.
A nurse reported that an 18 month old male received his 1st dose of Prevnar, as well as, IPV on 9/20/00 and 7 days later, developed an entire body blisters (zoster-type lesions). The pt was referred to a dermatologist and treated with alclometasone dipropionate. Additional information received on 1/23/01 included tests results.
Developed extreme fussiness (inconsolability) 5hrs after vaccine administration with fever to 102.3 (7pm the evening of the 4th). Around 11pm on the 4th had first episode of diarrhea which continued for the next 16hrs (until the afternoon of the 5th). Had 1 episode of diarrhea with red mucous in it the afternoon of 9/5.
Patient woke up crying and was shaking slightly at 3:30 a.m.  His father brought him downstairs, checked his temp, and gave him water.  He had a slight fever of 99.  The highest his temp reached was 101.6.  He was drinking water when he went limp and started seizing, it lasted a few minutes.  We called 911.  He passed out immediately after he stopped seizing.  He was "out of it" for at least 15min.  We went to the hospital where they gave him an IV, drew blood, took a urine sample, and X-Rays.  They didn't find anything wrong with him and said he'd had a febrile seizure.  At 12:00 p.m. that same day we saw his pediatrician and he explained it was likely caused by the ProQuad vaccine.  Patient received the MMR, Hep A, Hep B, Varicella, and influenza on 11/29/2013 as seperate shots with no adverse reactions.
Pt had fever for few hours within 24 hours after the shot. The injection site started to develop redness and painful swelling soon after. The redness continue to spread. It's now at about 6 inches below the injection site today. The symptoms suggest there's injection-related bacterial cellulitis. Pt started taking Amoxicillin 250 mg twice daily on 4/26/19. Talked to the patient on 4/27 morning, symptoms are not resolved and the redness is still spreading.
PATIENT EXPERIENCED LIGHTHEADENESS, NAUSEAU, WEAKNESS TO LEFT ARM, NUMBNESS TO LEFT ARM, AND PATIENT STATED "IT IS HER SEVERE MIGRAINE" 15 MIN POST VACCINATION WITH PFIZER COVID DOSE. PATIENT EXPERIENCED SIMILAR EFFECTS 2 DAYS AFTER SHE RECEVIED HER 1ST DOSE OF JANNSSEN VACCINE on June 18, 2021. NOT A NEW ONSET. PATIENT STATED FORGOT MIGRAINE MED AT HOME. 911 WAS CALLED HOWEVER PATIENT REFUSED TO GO TO ED. HUSBAND PICKED UP PATIENT.
Day after getting shot started noticing swelling on upper arm. Elbow is sore. Soreness continues but no swelling. Pt has been taking IBU (otc).
pain in injection site lasting 9 days Rash and Itching on day 9 lasting for 4 Days
I experienced flu like symptoms including body aches. It was difficult catching my breath and I was concerned. I took some TYLENOL and ibuprofen. After a few days, the symptoms went away, except for the shortness of breath. In March 2021, I went to the doctor and had an EKG & blood work done. I had A-fib and my heart had an irregular rate & rhythm. Later, I saw a cardiologist that same month. My heart became enlarged and I was having problems with my lungs. I was prescribed a boatload of medications such as CARDIZEM, blood thinners, and COREG. In October 2022, I was hospitalized and comatose for two and a half weeks. My right lung spontaneously filled with fluid. The doctors had to drain the fluid. In March 2023, I went back to the hospital because I was diagnosed with pneumonia. I still have problems with my lungs and my heart rate hasn't stayed stable. I still have difficulty breathing.
Intractable vomiting and diarrhea along with chills and fainting.  Lasted almost 18 hours
persistent high pitched crying, difficult to console; drawing up legs refusing to use; started 3 hr p/inject; PE neg; afeb
When nurse was in the process of administering the vaccine, the fluid leaked out between the needle and the syringe.  The impression is that at least half of the dose was lost and therefore not received by the patients.  It is unsure how much, if any, was injected to the patient or if it was all lost/leaked.  Patient has been self monitoring and reported no side effects besides the site pain.  Guidance was sought from Moderna on whether the patient should receive another shot since they did not get a full second dose.
Administered expired vaccine to the patient, after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to the patient, after the manufacture date of expiration) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to the patient, after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to the patient, after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Date the vial was initially stored in the refrigerator was unknown. The vial did not undergo any temperature excursions. Vaccine manufacture date of expiry reported was 24-Oct-2021. No treatment details were reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow-up document included reporter details.
This spontaneous report as received from a nurse refers to a 18 year old patient of unknown gender. Medical history and concurrent conditions were not reported. On 05-MAR-2015, the patient was vaccinated with an improperly stored GARDASIL dose 1, lot # K005881, expiration date 14-JAN-2007 (dose and route were not reported). No adverse event reported. No co-suspect and concomitant therapies were reported. This is one of several reports from the same source. Additional information is not expected. All follow up requested to complete the case were received.
Patient received Pfizer for the first dose and Moderna for the second. Patient is only 12 years old.
Pain; Chest is very pain, a lot of that on her chest/ chest pain continued for 1-2 weeks; She got worse and worse; Compression of the heart; Being very tired; Could not sleep; Blue color on her chest,It looks like when someone hits something and the skin has a blue color; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain), CHEST PAIN (Chest is very pain, a lot of that on her chest/ chest pain continued for 1-2 weeks), CONDITION AGGRAVATED (She got worse and worse), SKIN DISCOLOURATION (Blue color on her chest,It looks like when someone hits something and the skin has a blue color) and INSOMNIA (Could not sleep) in a 58-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 10-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jun-2021, the patient experienced SKIN DISCOLOURATION (Blue color on her chest,It looks like when someone hits something and the skin has a blue color). On 05-Jul-2021, the patient experienced INSOMNIA (Could not sleep). On 06-Jul-2021, the patient experienced CARDIAC DISCOMFORT (Compression of the heart) and FATIGUE (Being very tired). On an unknown date, the patient experienced PAIN (Pain), CHEST PAIN (Chest is very pain, a lot of that on her chest/ chest pain continued for 1-2 weeks) and CONDITION AGGRAVATED (She got worse and worse). On 06-Jul-2021, CARDIAC DISCOMFORT (Compression of the heart) and FATIGUE (Being very tired) had resolved. At the time of the report, PAIN (Pain), CHEST PAIN (Chest is very pain, a lot of that on her chest/ chest pain continued for 1-2 weeks), CONDITION AGGRAVATED (She got worse and worse), SKIN DISCOLOURATION (Blue color on her chest,It looks like when someone hits something and the skin has a blue color) and INSOMNIA (Could not sleep) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: increased (High) Fast heartbeat.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       It was reported that patient was not recovered on 26 Jun 2021. And patient was hospitalized for 3-4 hours on 06 Jul 2021. No concomitant medications were reported. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: Additional information received. Two new events were added which are cardiac discomfort and fatigue.