chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Shrunk a little bit; really hot; Shivering; Tiredness; Fever; This is a spontaneous report from a contactable consumer.  An 89-year-old female patient received the second dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EN5318), via an unspecified route of administration in the left arm on 04Feb2021 at 89-year-old at a single dose for COVID-19 immunization.  Medical history included macular degeneration from an unknown date and unknown if ongoing.  There were no concomitant medications. The patient previously received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EL3249; left arm) for COVID-19 immunization on an unknown date.  The patient experienced the following events and outcomes: shivering (non-serious) on 10Feb2021 with outcome of recovered on 11Feb2021, tiredness (non-serious) on 10Feb2021 with outcome of not recovered, fever (non-serious) on 10Feb2021 with outcome of recovered on 11Feb2021, shrunk a little bit (non-serious) on an unspecified date with outcome of unknown, really hot (non-serious) on 10Feb2021 with outcome of recovered on 11Feb2021.  The patient underwent lab tests and procedures which included body temperature: highest her temperature got was 100 on an unspecified date. About six days after the patient had her second COVID shot, the patient experienced shivering and tiredness. It was reported that the patient had shrunk a little bit starting on an unspecified date.  At the time of the report, over the last 3 days, the patient experienced the side effects. "It could be from something else. She could have gotten something. She did not know." The patient also had a fever a few times. The patient would go between shivering and really hot so she would take her temperature. The patient did not normally have a fever. When the shivering came on, she was trying to cook, and could not hold the spoon in her hand. The patient did not know what was wrong, but she was cold. All she wanted to do was sleep. The only symptom she still had was being tired. The night before the report, the patient woke up so warm and was sweating; her pajamas were damp. The patient could not sleep in them, so she had to go change. The patient has not shivered since then. The tiredness was persisting. The patient slept on and off all day today, but she was feeling better in general. The patient took her temperature every day. "The highest her temperature got was 100."
Information has been received from a 73 year old female patient with no pre-existing conditions who on approximately 24-MAR-2010 was vaccinated with a dose of ZOSTAVAX (Merck). The patient did not take any medications of any type. On 31-MAR-2010 the patient experienced weakness which started in both legs approximately 1 week after having taken the ZOSTAVAX vaccine (Merck) shot. It was reported that the weakness was unable to hold her weight (123 lbs). There was no fever and no less of appetite. The patient also reported that her body felt tired, but not sleepy. The patient did not seek medical attention. At the time of the report, the patient had not recovered from these events. "Weakness started in both legs" and "body feels tired" were considered to be disabling by the reporter. Additional information has been requested.
Information has been received from a physician concerning a 19 year old Caucasian female student with moderate dysplasia, HPV, and abnormal pap smear (CIN 2 with high risk HPV types) who on 24-APR-2008 was vaccinated IM in the left deltoid with the first 0.5 ml dose of GARDASIL (Lot# 659437/1266U).  Concomitant therapy included DEPO-PROVERA.  On 24-APR-2008 the patient became dizzy, clammy, flushed and reported that the injection was painful.  Subsequently, the patient recovered on 24-APR-2008 from dizzy, clammy, flushed and injection pain.  Unknown medical attention was sought in the office.  No product quality complaint was involved.  Follow up information was received that indicated that immediately following the injection, the patient became very dizzy, clammy, and her cheeks were flushed.  The patient felt as though she was going to lose consciousness.  She also reported visual and audible "waves".  The symptoms lasted approximately 8 - 10 minutes.  On 24-APR-2008, the patient was recovered.  Additional information has been requested.
Rash / on the left abdominal wall; On the left abdominal wall / some irritation; Herpes zoster; This case was reported by a nurse via and described the occurrence of rash in a 58-year-old male patient who received Herpes zoster (Shingrix) (batch number 9H3Z4, expiry date 27th August 2022) for prophylaxis.   On 18th November 2020, the patient received Shingrix .5 ml. On 22nd November 2020, 4 days after receiving Shingrix, the patient experienced rash, skin irritation and herpes zoster. On an unknown date, the outcome of the rash, skin irritation and herpes zoster were unknown.   It was unknown if the reporter considered the rash, skin irritation and herpes zoster to be related to Shingrix.  Additional details were provided as follows: This case was reported by nurse. The patient received 1st dose and experienced  rash,abdominal wall with some irritation and herpes zoster. On 24th November the patient visited physician office and was diagnosed with Herpes zoster. The current outcome was unknown. The reporter consented to follow up. No further information was available.
Red erythamatous itchy rash to arms, torso and legs began approx. 4 hours after vaccination. Patient presented to medical after 2 hours. Pt. showed no signs of acute distress, no difficulty breathing, non toxic. Patient was treated w/150 mg. Benadryl IM and 100 mg prednisone by mouth immediately and was monitored for 30 minutes, until symptoms resolved, then was prescribed Prednisone taper times 6 days, Zantac 150 mg by mouth 2X per day and Benadryl 25 mg. by mouth every 6 hours.  Patient was instructed to return if symptoms persisted, rebounded, or worsened and to f/u in 1 day.
Shingles vaccine. Sore, red rash 1.5 "; sore, hard swollen lump size of half a gpoose egg; pain in neck cords on same side as vaccine (left). Maximum discomfort at 2-3 days following vaccination.
This subject received Moderna Covid vaccine on 26AUG2020 (Lot 7006320001)and 28SEP2020 (Lot 7006320004) within a clinical trial. All adverse events have been reported within the study per protocol. She developed chills (29SEP2020-08OCT2020), pain at injection site (29SEP2020-06OCT2020), fatigue (29SEP2020-28JAN2021), forgetfulness (brain fog) (30SEP2020-31OCT2020), increased sweating (09OCT2020-11OCT2020) and intermittent head twitching (09OCT2020-07NOV2020). Evaluation of her forgetfulness included a head CT and virtual visit with a neurologist. No further neurological evaluation was performed and the forgetfulness eventually resolved.      Subject reported left arm pain (mid-humeral area) that began 27AUG2020 but eventually localized to the left shoulder.  She was referred to an orthopedic surgeon who initially diagnosed bursitis of left shoulder. Treatment with steroids and PT was not successful and MRI revealed left shoulder rotator cuff tear. Surgery repair was successfully performed 04FEB2021. The orthopedic surgeon did feel this was a shoulder injury related to vaccine administration.   Subject developed axillary lymphadenopathy onset 26DEC2020, diagnostic mammogram and ultrasound were negative.  Multiple biopsies of axillary lymph nodes showed nonspecific sinus histiocytosis and pronounced Langerhands cell hyperplasia, felt to be consistent with a connective tissue disorder. Subject reported PET scan 10MAY2021 with generalized lymphadenopathy noted. Fatigue and feverish feeling without fever began 14MAY2021 and generalized arthralgias 26JUL2021. Subject saw rheumatologist who diagnosed a connective tissue disorder (onset 25MAY2021), type uncertain. Subject has a history of rash which has come and gone since 1995. Subject feels her rash is related to wheat sensitivity, it was diagnosed at one time as pityriasis lichenoides chronica however other dermatologists did not agree.  Rash changed in character and became more extensive NOV2021. Skin biopsies obtained 29MAR2022 showed cutaneous T-cell lymphoma.  Per subject PET scan showed uptake in several areas including the stomach, uterine fundus, axillary and inguinal lymph nodes.  Uterine biopsies were negative however an outpatient hysterectomy was performed 01SEP2022.  Subject is being evaluated and treated at a specialty clinic for T-cell lymphoma. Blood work 14SEP2022 shows she is positive for the subtype Sezary syndrome with leukemic involvement. She began UVB light therapy 27SEP2022 and has noted improvement in her rash. However, new lymphadenopathy has developed on the right side of her neck which is now being evaluated.
Developed headache & flu-like sx for approx 2 days followed by slight numbness of hands & feet. Developed weakness that progressed to paralysis.
Per res. being taken to surgery for a perforated diverticulum. ICU, resident had made it through surgery, resident is off the vent, not really responsive at this time and will be keeping a close eye on him.
Fever 102 for 12 hrs, rash, sore throat, h/a; 1JUL91 feeling better still has sl rash;
Information has been received from a physician concerning a patient who in approximately May 2007, was vaccinated with a 0.65ml dose of Zostavax (Oka/Merck).  In 2007 the patient developed shingles.  Unknown medical attention was sought.  The patient's status was recovering.  No product quality complaint reported.  No further information is available.
Chest pain and shortness of breath (likely myocarditis) lasting for 6-8 hours Heavy nosebleed 10 hours after myocarditis started
Approximately 24 hrs after receiving FLUMIST (2013) intranasal, pt developed itchy red rash. No fever, no hives no lip swelling no SOB. Pt denies allergies to food or meds. Seen in office 10/15/13 AM - PE: significant for diffuse erythema multiforme minor rash on face, trunk/back, extremities. C/o pruritus. Appropriate dose of diphenhydramine 12.4 mg/5ml given, UA, rapid strep, tcx sent. Patient continues to have rash while in office.  Note: patient has has 2 previous doses of FLUMIST in 2011 and 2012, but not previously in 2013.
Information has been received on 06-JUN-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 20-JAN-2014, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. In June 2017, the patient was treated by a physician for a persistent and severe vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient has suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Information has been received from a licensed practical nurse concerning a 15 week old patient who on 25-MAR-2008 was inadvertently vaccinated with the first dose of ROTATEQ. No adverse symptoms were noted. This was not a product quality concern. Additional information has been requested.
Breakthrough case admission after 2 vaccines  Moderna 1/5/21 Lot# 039K20A;  Moderna 2/2/21 lot# 028L20A
unconsolable high pitched screaming for approx 2-2 1/2 hrs; slept approx 20 mins & then resumed screaming for 1-1 1/2 hrs, vomited x 1 p/screaming; febrile but not measured;
J96.00 ACUTE RESPIRATORY FAILURE 8/3/2022 IDIOPATHIC PULMONARY FIBROSIS
We all got COVID; We all got COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Heart condition" (unspecified if ongoing), notes: My husband has a heart condition so we knew it was very important to get the vaccine. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "We all got COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: unknown, notes: 'We all got COVID'.  Clinical course reported that My whole family got the 1st and 2nd dose as soon as it became available. My husband has a heart condition so we knew it was very important to get the vaccine. We did not get COVID so we thought we were all good, but we still got the booster as soon as we could. We thought we were definitely good then, but then we all got COVID. The commercial emphasizes the fact that you can never be too careful and it is our responsibility to ourselves and our community to take action and get the shot. We were all very surprised when we got the test done (we thought we had a common cold). Fortunately the symptoms were fairly minor.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202200045403 Same reporter/drug/event, different patient;
Information has been received from a physician concerning his 64 year old female employee with no known drug allergies and no pertinent medical history, who on 07-JUL-2008 was vaccinated subcutaneously with ZOSTAVAX (Lot # 659406/0298X) 0.65 mL, into her left upper arm. There was no concomitant therapy. On 15-JUL-2008, the patient developed pain in her left shoulder and then a painful red, papular rash that ran under her left axillary area and down her arm. There were no vesicles present, but there were 15+ patches that ran along the left C4, C5 dermatome. There was no fever. The patient also had nerve pain, loss of sleep, sensitivity to touch & cold air, burning and itching. The patient sought medical attention at the office. The patient was diagnosed as definitely having shingles and was treated with VALTREX. At the time of the report the patient was recovering. The patient was enrolled in the Varicella Zoster Virus Identification Program to identify if VZV is present and if it is present to identify if it was associated with the wild-type VZV strain or with the OKA/Merck vaccine VZV strain. The sample was collected on 23-JUL-2008. The result was inadequate specimen, negative for B-globin and no strain I.D. This is one of several reports received from the same source. Standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. No further information is available.
After first dose in June, menstruation started 8 days early, which is highly unusual, a day or two after vaccination. This time menstruation started 14 days early, two days after vaccination.
Presented to ED with atrial fibrillation with elevated HR (130s) Also had potassium of 2.9 I think it is entirely possible this is NOT related to th vaccine
Muscle pain of the upper right arm for a period of three days, followed by swollen painful lymph nodes in the left armpit, which are ongoing.
Flu-like symptoms: diaphoretic, clammy, headache, GI disturbance (frequent bouts of gas/small amount of stool), sneezing, runny nose, body aches (marked), eyes sting (but not red or itchy), poor appetite, inability to sleep, restless leg syndrome, marked fatigue/malaise.  Symptoms lasted 3 days (past 3 days the worst: September 18/19/20) then began to resolve. I was unable to attend the Meeting on Sept 19/20 due to needed to stay in bed.  Feeling somewhat better today (Sept 21) so will attempt to go to the medical meeting. I am a physician. I have not seen my doctor. I thought I had a virus at first so was going to let it run it's course but after 3 days I am feeling better (too short for a viral illness). Benadryl taken for runny nose helped as well as Ibuprofen. I'm retired and had not been in the public since Sept 1, 2019.
Presented with SOB, diarrhea x 3 days; admit 9/19 to ICU with Covid PNA; 9/19 maxipime, steroids, singulair, zinc started, 15 NRB O2, ? Convalescent plasma (I'm thinking she did not get it)Documentation on FFP is contradictory but it does appear in final procedure coding.; 9/23 worsening kidney and resp function; family decided on comfort care
On 3/28/01, the child had a temperature of 99F and cold symptoms. She received vaccines at health dept and later in the evening she developed a fever of 101F-103F. She was taken to the hospital and dx'd with pneumonia and otitis. Hospitalized for 2 days with complete recovery. No problems after 4 month shots on 5/25/01.
About 3 days after first vaccine I started experiencing tinnitus, pressure/tension at the base of my skull and symptoms of occipital neuralgia as significant tingling over my scalp and mildly in my face. I did not put this together with the vaccine until is clearly  worsened after my second.
Complained of pain in right arm after immunizations yesterday. Awoke this arm right arm edematous, erythematous.
infection of SARS-COV-2; infection of SARS-COV-2; This is a spontaneous report from a contactable healthcare professional.  A 31-year-old male patient started to receive received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EL0140), intramuscular into the left arm on 18Dec2020, at 10:30 as single dose for covid-19 immunization.  There was no medical history and no concomitant medications.  The patient experienced infection of SARS-COV-2 on 25Dec2020. Details were as follows: The patient received the first dose of the two dose series. On 20Dec2020, he was exposed to COVID-19. Official positive diagnosis of COVID-19  was made on 25Dec2020. Patient had symptoms of fatigue, joint pain and a small fever on an unspecified date, and had been exposed to SARS-COV-2  on 20Dec2020, and the infection on 25Dec2020.  The patient underwent lab tests and procedures which included sars-cov-2 test which was positive on 25Dec2020.  The patient was scheduled to receive second dose of the vaccine; he will be out of quarantine around five to six days before that dose. The outcome of infection of SARS-COV-2 was recovering.; Sender's Comments: The efficacy of a drug varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect drug BNT162B2 to the reported events drug ineffective and COVID-19 cannot be ruled out.
Chills, Tingling in top of head, Headache, Nausea, LOC at work.
I got COVID; I got COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown) and as dose 6 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; bnt162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "I got COVID". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid. Clinical course: Consumer stated, they got COVID, they had all 6 of vaccines that were available up until this latest one. Patient had two of the Bivalents but not the latest one, they were all Pfizer Vaccines. Patient got COVID couple of weeks ago, was prescribed Paxlovid.   The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5, bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300321075 same patient, different drug/AE;
Sudden onset of fever of 103.5, febrile seizure, emesis x 1 episode, lethargy, & behavior changes for 24 hrs. She also had pin point dot type rash over dorsum of hands & lower arms primarily. Whole event lasted about 48 hrs total.
2-3 days later, muscle aches, tingling in hands, swelling in extremities, exhaustion.  2/24/22 - Hives all over body
patient got Menactra SQ instead of IM, no AE; Initial information received on 09-Sep-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a female patient of unknown demography who received vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] and reported that patient got Menactra SQ instead of IM (incorrect route of product administration).  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medicatiuon(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot number not reported via subcutaneous route in unknown administration site.  It was a case of actual medication error due to inappropriate route of vaccination.  At the time of report, adverse event was not reported.  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.  Information on the batch number was requested.  List of documents held by sender: none.
she had covid vax 1st on 9/10/21 moderna lot number 062E21A and 2nd on 10/8/21, moderna lot # 076C21A she began noting mania w/in a few wks of 1st covid vax and has been diagnosed w/ bipolar sx since  from psych note on 30 Jan 2022 The patient is a 53 y.o. female with a history of small lymphocytic lymphoma, sickle cell disease, and RLS, and a past psychiatric history postpartum depression  admitted to hospital on 1/19 due to worsening episodes of agitation and inappropriate behaviors.    Given her history of PPD (a  risk factor for bipolar disorder), a history of past depressive and possibly hypomanic episodes,and a family history concerning for depression and possibly bipolar disorder, it seems that the patient could have premorbid tendencies toward an affective disorder consistent with the bipolar spectrum. In subsequent interview with patient, she states she has been "manic" before in her previous marriage that ended the marriage. Following steroid taper (last day 1/21) and collateral c/f past manic episodes, symptoms are now more consistent with bipolar I disorder rather than steroid-induced mania, this seems to be unmasked by her recent covid vaccines.  No recent serious behavior issues prior.  Her and her husband both noted signif changes after the covid vaccines.   DSM-5 DIAGNOSES: 1. Bipolar I disorder with mixed features 2. History of steroid-induced acute mania (of note she had been on high doses of steorids to 1 mg/kg daily early 2021 prior to dx of bipolar and covid vax w/o manic sx) 3. History of postpartum depression   Other relevant diagnoses: - COVID-19 positive, symptomatic - Sickle cell disease - H/o pulmonary hypertension - H/o small lymphocytic lymphoma