chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient complains that right arm red with blisters from shoulder to hand the next day after injection.  Skin on arm peeled for 2 weeks.  2 big knots came up on elbow.  Seen Ortho doctor and tried to drain elbow but nothing came out so injected with cortisone. Now another knot has come up between  elbow and hand, hard and painful.
This case was retrieved via a search of scientific literature on 14 November 2011. This reporter also reported other adverse events, which were captured in case numbers 2011-11217, 2011-11218, 2011-11219, 2011-11220, 2011-11221, 2011-11222, 2011-11223, 2011-11225, 2011-11226, 2011-11227, 2011-11228, 2011-11229, 2011-11230, 2011-11231, 2011-11232, 2011-11233, and 2011-11234. "Background: In 2004 the Clinical Consult Case Review (CCCR) working group was formed within the CDC funded Clinical Immunization Safety Assessment (CISA) Network to review individual cases of adverse events following immunizations (AEFI). Methods: Cases were referred by practitioners, health departments, or CDC employees. Vaccine Adverse Event Reporting System (VAERS) searches and literature reviews for similar cases were performed prior to review. After CCCR discussion, AEFI were assessed for a causal relationship with vaccination and recommendations regarding future immunizations were relayed back to the referring physicians. In 2010, surveys were sent to referring physicians to determine the utility and effectiveness of the CCCR service. Results: CISA investigators reviewed 76 cases during 68 conference calls between April 2004 and December 2009. Almost half of the cases (35/76) were neurological in nature. Similar AEFI for the specific vaccines received were discovered for 63 cases through VAERS searches and for 38 cases through PubMed searches. Causality assessment using the modified WHO criteria resulted in classifying 3 cases as definitely related to vaccine administration, 12 as probably related, 16 as possibly related, 18 as unlikely related, 10 as unrelated, and 17 had insufficient information to assign causality. The physician satisfaction survey was returned by 30 (57.7%) of those surveyed and a majority of respondents (93.3%) felt that the CCCR service was useful. Conclusions: The CCCR provides advice about AEFI to practitioners, assigns potential causality, and contributes to an improved understanding of adverse health events following immunizations". A 1.3-year-old patient (sex not reported) received the following injection on an unknown date (route, site, manufacturers and lot numbers not reported): DTaP, Hib VACCINE, HEP B, MMR, and VAR. The patient's medical history was reported as healthy. On an unknown date the patient developed cerebellar ataxia nine days after the vaccines. The causality was reported as probable. The outcome was not reported. Documents held by sender: None.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 80-year-old male patient received BNT162b2 (BNT162B2), on 03Apr2022 at 10:00 as dose 4 (booster), single (Lot number: FP4554) at the age of 80 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), 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: "High Blood pressure" (unspecified if ongoing); "Type 2 Diabetes" (unspecified if ongoing); "Heart (ICD)" (unspecified if ongoing); "Known allergies: Iodine Contrast dyes" (unspecified if ongoing). Concomitant medication(s) included: SIMVASTATIN, start date: Jan2010, stop date: 21Jun2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 20Jun2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (14Jun2022) Negative, notes: Felt much better by 13Jun2022 tested negative 14Jun2022; (20Jun2022) Positive, notes: 19Jun2022 started having coughing return and Tested positive on 20Jun2022. Therapeutic measures were taken as a result of drug ineffective, covid-19.  clinical course:  Symptoms were identical to the first infection.AE treatment: Benzonatate 200mg, Prednisone 20mg, Albuterol HFA.
Approx. 2 weeks after vaccination in right arm there was extreme pain in upper arm area. Any sudden movement caused excruciating pain. Could not lift right arm upward or perform normal activities with arm. Could not sleep on arm. As long as arm was in a low position there was no pain; could not do daily activities such as comb hair, wash neck or back, shave underarms, wipe posterior; difficulty pulling up pants, putting on shoes. Arm felt as if all the arm fibers were torn apart. The pain came on gradual after the vaccination then became intense. Seen by orthopaedic doctor who recommended physical therapy.
Patient requested moderna, intern giving vaccine thought she wanted Pfizer.  Intern verbalized to patient before she gave her the vaccine that she was giving Pfizer, and patient did not stop her to tell her it was incorrect.  Intern administered vaccine and discovered patient wanted moderna afterwards.
This was a Covid Booster.  I first received Janssen vax on 4/1/2021 and experienced a breakthrough Covid case on 8/2/2021.  The day after the Moderna booster I felt typical covid vax side effects -- headache, exhaustion.  On Saturday, 11/6, I started experiencing a dullness in my left hand and overall minimized sensation.  Since then I've experienced general tingling, including arms, hands, legs and feet.  I've had hours-long stretches of time where either hands or feet have been exceedingly cold but ultimately returned to normal.  Additionally, I'm experiencing mildly shaky hands.  I have a general feeling of disconnect and anxiety which in turn is leading to loss in appetite.  Difficulty sleeping.
Maculopapular lesions over the 3 sites of injection app 1 in in diameter.
Reported here, 48 hours post vax, with left arm that had a area of 17cm X 18cm with erythema and induration. Pt complained of pain but no other symptoms.
Extreme pain in arm and joints. Pain eventually continued and still hurting. In left shoulder, shoulder blade, tricep near shot site, mid back, neck, down to elbow and wrist, some tingling, some loss of feeling , left arm often goes numb. It?s been 3 weeks. Still suffering
Right armpit, looks like a lymph node is swollen, about the size of a tennis ball; Right armpit is very tender; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in Arm Right on 20Sep2021 17:30 (at the age of 45 years old) as dose 1, single for COVID-19 immunisation at pharmacy. Medical history reported as none. No investigation assessment. There were no concomitant medications. Patient historical vaccine included Tetanus Vaccine on an unspecified date (it was several months ago) as single for immunisation and experienced got kind of ill. Patient did not received other vaccine within four weeks of COVID vaccine. The patient experienced right armpit, looks like a lymph node is swollen, about the size of a tennis ball, right armpit is very tender on 22Sep2021. Reported as, She had the first dose of the Pfizer-BioNTech COVID-19 Vaccine on Monday, the 20th. She got up this morning and her lymph nodes on her right armpit where she got shot was very tender and swollen with the size of a tennis ball. She called her doctor and was advised to contact Pfizer. Outcome of all the events were unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Information has been received from a physician via practice manager referring to a 52 year old female patient. Her medical history and past drug history are unknown. On 08-MAY-2015 the patient was vaccinated with PNEUMOVAX 23 (lot # J008799, expiration date 16-APR-2015) dose 1, 0.5 ml, intramuscular in the left arm. Concomitant therapies included amphetamine aspartate, amphetamine sulfate, dextroamphetamine saccharate, ADDERALL TABLETS, fluticasone propionate, ADVAIR, albuterol, SEROQUEL. There was no relevant laboratory data or tests. As of 08-MAY-2015, she no longer took PNEUMOVAX 23 and the outcome of being administered an expired vaccine was unknown. Additional information has been requested.
redness and itching at injection site and swollen lymph node in administered arm started 4/25/21
Around 4pm on 9/25 became fatigued, woke up on 9/26 around 6am with mild headache, fatigue, mild chills and mild body aches,  pain at injection site which started after the injection.  Later on Sunday the 26th towards the afternoon noticed shortness of breath with exertion such as walking, mild palpitations and increased pulse rate. During the night while sleeping would wake up with palpitations and could feel heart pounding. Monday 9/27 the fatigue continued as well as mild headache. Shortness of breath, palpitations, heart pounding and increased pulse was more noticeable and I had to stop multiple times while showering and getting myself dressed. In the afternoon while speaking with my Doctor I took my blood pressure which was 139/93 (high for me), pulse rate in the 90's (also high for me). I was up from 2:30 am to 4am Tuesday morning with palpitations.  On Tuesday my symptoms started to diminish and slowly get better. It took until 10/4 for palpitations to disappear.
3/15/21: Incidental findings of ST-segment elevations on cardiac telemetry and diffuse ST-segment elevations on EKG--patient was admitted on 3/13 for altered mentation and severe hyperglycemia - Stopped treatment of metastatic melanoma in November 2020 (was on Nivolumab)  - Has Pfizer COVID Vaccine on 3/11/21  3/15:  - Diffuse ST elevations noted on telemetry; patient was asymptomatic - Cardiac enzymes elevated - Patient had STAT echo which was significant for WMA - Left heart cath- normal coronaries; suspicious for Myocarditis - Methylprednisolone started  80 mg IV q8h  3/16: Cardiac enzymes trending down  - CK trending down - patient remains asymptomatic
This is a spontaneous report received from a contactable consumer. The reporter is the patient.  A 71-year-old male patient received BNT162b2, BNT162b2 OMI ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 70 years for COVID-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), 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 patient had no known allergies. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 19Dec2022, outcome "recovered" (29Dec2022) and all described as "Positive COVID-19 test". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (19Dec2022) Positive; (29Dec2022) Negative. Therapeutic measures were taken as a result of drug ineffective, COVID-19 which included ritonavir/ nirmatrelvir from 20Dec2022 to 24Dec2022.  The information on the batch/lot number for BNT162b2, BNT162b2 OMI ba.4-5 has been requested and will be submitted if and when received.
BAD REACTION; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unk) dose, start therapy date were not reported for prophylactic vaccination (dose number in series 1). The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced bad reaction. Laboratory data (dates unspecified) included: Antibody test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of bad reaction was not reported. This report was non-serious.
pt got up on 4/16/2021 and noticed he has ringing in his right ear.  He states the ringing noise is like a tone and constant.  When he closes his left ear it is really pronounced.  Pt says if continues he will see his PCP.
Fever, body aches, joint pain, migraine, arm pain, felt like my chest was burning inside, inflammation etc.
This spontaneous case initially received on 06-Oct-2016, was reported by a health professional and concerns a 48-year-old female patient. Weight: not provided; Height: not provided It is unknown whether AFLURIA has been tolerated by the patient in the past. Administration of company suspect drug(s): The patient received AFLURIA from 16-SEP-2016 to 16-SEP-2016. Dose regimen: 0.5 ml once, Route of administration: Intramuscular. Batch number: WT53106. The product has been stored correctly. No additional suspect drugs. Adverse reactions/events and outcomes: In Sep-2016 two to three days after receiving the vaccine, the patient experienced malaise and anxiety, stating that she felt nervous, couldn't eat, and felt on edge (outcome: not recovered / not resolved). Adverse reactions have not resolved to day. No additional information is known. Reporter comments: The healthcare professional considered all events as non-serious. Additional information received on 24-Jan-2017: QA investigation for Lot number WT53206 (PRD-18098) was also extended to the sister lot WT53106. Both batches WT53206 and sister dispensed batch WT53106 are derived from the same formulated bulk lot (0906USF284). Final assessment: Risk has been excluded. The review and investigation of the manufacturing, dispensing, shipping and product testing of Influenza Vaccine lot: WT53206 found no evidence of a product quality issue to prompt the potential 'vaccine reaction'.
On 8/29/06 pt came in with a rash child has positive chicken pox. About 30 lesions.
This spontaneous report was received from a medical assistant via company representative regarding a 2 months old infant. Information on pertinent medical history, drug reactions/allergies and concomitant medication was reported as unknown. On 20-FEB-2018, the patient received ROTATEQ lot# N021027 with expiry date of 27-FEB-2019, orally for prophylaxis. The patient spit up. On the same day, the patient received a second dose of ROTATEQ lot# N021027 with expiry date of 27-FEB-2019. Patient also received PREVNAR 13 and PENTACEL. Outcome of the event "Infantile spitting up" was reported as recovered. Causality of the event "Infantile spitting up" was not reported.
Myalgia states astham flared up with dose 2, took xoponex inhaler. with 1stdose had diarrhea Narrative:
Pt had 2 x episodes of feeling unwell associated with cyanosis of the lips. Self resolved after 5 minutes or less. Has no known risk factors for cyanosis such as methemaglobinemia
After the vaccine she was sleeping all day. In the morning he had a lot of chest pain, nervousness and a fast pulse. This lasted at about 40 minutes and the symptoms gradually subsided. In the following months she has had a sensation of tachycardia. This had never happened to her. Her menstrual flow has changed, since the vaccine her bleeding is a lot and she is in a lot of pain. Another symptom is that she has lost her appetite.
red rash ..itches like crazy..started in mid stomach area and gone to chest arms and legs...i am NOT having any difficulty breathing at this point and have taken Benadryl to hopefully help the itching.
Patient immediately had a syncopal episode with associated flushing/sweating and dizziness. Vitals: 93/67, 111 and 19. Patient given OJ and instructed to take deep breaths. Patient recovered. Patient stable and released from the vaccination site at 18:40.
20 cm x 10 cm swelling, erythema, warmth of left upper arm. Recommend cool compress, antihistamine. (Patient currently on an antibiotic for UTI). Temp: 99.2 Tympanic. No tongue swelling, throat swelling, cough, wheezing, or shortness of breath.
Pt recvd vax & 2 minutes later became clammy,pale,faint & devel rash on arm.Tx w/ DPH.
This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received the Moderna Covid 19 vaccine after temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patient received the Moderna Covid 19 vaccine after temperature excursion) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. No Medical History information was reported. On 21-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. In April 2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received the Moderna Covid 19 vaccine after temperature excursion). On 21-Apr-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient received the Moderna Covid 19 vaccine after temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received the Moderna Covid 19 vaccine after temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patient received the Moderna Covid 19 vaccine after temperature excursion) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. It was reported that there had been temperature excursions with the freezer that was happened for weeks since April 2022. Storage condition at the time of the excursion were frozen. It was reported that Lot numbers: 065K21A and Lot numbers 045L21A had undergone temperature excursion and maximum and minimum temperatures reached were 30 Fahrenheit Degrees and minus 18.9 Fahrenheit Degrees respectively. It was reported that the vaccines suffered 2 temperature excursions since April, both lasted less than 1 minute and date the vials moved from freezer to refrigerator was unknown, they were now stored in frozen condition and no vaccine state change was observed. No treatment medications were reported.
(L) arm redness 10+cm round patch w/ mild erythema minimal swelling no warmth, tenderness no fever.
10:15 AM Pt received Moderna Vaccine 2nd dose shot 10:30 AM  Pt claimed had rapid heart beats. I took her BP(105/83) and pulse(93), my intern checked injection site and no redness on left arm. I asked pt should I call emergency number and she said YES. 10:45 AM Paramedics arrived, took vital signs and EKG, then transport out to hospital(ER).
I was also given the Flu Vaccine on the same day in the same arm as the Shingles vaccine.  I woke up with all over body aches and pain - it hurt to sit up or walk and coughing hurt my muscles around my ribs.  I had shivers from fever 102.9. I had a massive Migraine.  I was tired all day but the body pain was keeping me awake sometimes.  I also get the sweats when my fever is breaking after alternating Tylenol & Advil.  Head feels very heavy.
When mom woke pt up this am c/o dizziness and itching arm where HepB injection was given. Child went to school, they called and stated that child was c/o dizziness, abdominal pain, site red, warm to touch, itching and hard.
early morning after vaccine felt chest congestion and crackling sound in chest.  felt congestion for the next 6 days.  on tuesday 5/4 i could not breath.  went to the emergency room in an ambulance.  ER gave me oxygen and increased my lasix to double the dose.  chest xray showed fluid build up in the lungs. that night breathing retuned to normal.  spent two nights in the hospital with double doses of lasix each day. discharged on 5/6/2021
Arm - hurt; I got a little fatigued  - by the next day after the vaccine. One pain in particular - on the 17th  - I felt it inside of me toward the right front of my waist. Where the appendix could be hurting. It would hurt more when I was walking. I didn't feel it when  I was sedentary with sitting. At night, I would feel it like a cramp when I was lying down. On the 18th, it was hurting more. I had bloodwork appt coming up on that Thursday. The pain continued and was getting stronger. By Wednesday, I started feeling pain going down my right leg and up in my back. Thursday - bloodwork.  I saw the doctor on Friday. Had an examination - they figured out it was not the appendix. They thought it was gas. But I don't suffer from gas. They prescribed pills for nerves  - to release nerves inside intestines and OTC gas pills. It relieved it a little but didn't go away. They concluded it was a nerve thing connecting from my back. They gave me another medication for the back pain. Gabapentin and Baclofen.
Patient was administered Pentacel with an expiration date of 1/31/2023. Provider was notified immediately. Mother was contacted and advised of the error. Not other issues or reactions took place. The patient was in good health when he left the office and no other issues were reported.
tiredness and fatigue; arm soreness; This is a spontaneous report from a contactable consumer or other non hcp reported for her partner. The consumer reported for two different patients, it is the 2nd of the two reports. A 24-year-old female patient received bnt162b2 (PFIZER COVID 19 VACCINE), dose 1 via an unspecified route of administration on 23Apr2021 14:00 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. There were no medical history and concomitant medications. The patient experienced tiredness and fatigue on 25Apr2021 with outcome of recovered in Apr2021, arm soreness on 24Apr2021 with outcome of recovered in Apr2021. The events didn't result Emergency Room/ Physician Office.  Clinical course: Reporter adds her partner started to have the arm soreness on 24Apr2021; tiredness and fatigue 25Apr2021 then she started her period and pretty much got over everything after that.   No follow up attempts are needed, information about lot/batch number cannot be obtained.
child  day after immunization developed urticaria on face-     mild  coming and going  over next week- resolved with benadryl
Rapid onset in 12 hrs of left arm swelling/redness. MRI confirmed cellulitis, superficial fascitis. 4/21/06 Discharge Summary of 16 pages reviewed. Final diagnosis confirmed cellulitis. He appeared slightly confused at times, but seemed alert and appropriate when questioned. He described the pain as 10/10.
diarrhea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 11 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 22Nov2021 01:45 (Lot number: FK1527) at the age of 11 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "known allergies: Penicillin" (unspecified if ongoing); "known allergies: mayonnaise" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DIARRHOEA (non-serious) with onset 24Nov2021, outcome "unknown", described as "diarrhea". Therapeutic measures were not taken as a result of diarrhoea.  Additional information: No other vaccine in four weeks and no other medications in two weeks of vaccination. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination.  Follow-up attempts are completed. No further information is expected.