chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient presented back to clinic three days after receiving a dose of pneumococcal vaccine, complaining of local swelling and redness in the arm where the dose had been administered, which had developed the evening after the dose and had since worsened. Provider considered differential diagnosis of allergic reaction vs cellulitis and treated for both. Patient was prescribed oral prednisone, diphenhydramine, and cephalexin for 7 days. Upon followup by phone the following day, patient's symptoms were resolving. Patient last previous dose of pneumococcal vaccine had reportedly been given 1997 at another clinic.
12 hours after vaccine-intense pain at site with fever as high as 101.7. 24 hour post vaccine lue-lle neuropathy and meningeal irritation with arthralgia.
COVID 19 Treatment; COVID 19 Treatment; dose #1: Unknown / dose #2: Pfizer / dose #3: Pfizer / dose #4 Pfizer / dose #5 Moderna; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 62-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Mar2021 as dose 2, single (Lot number: EW6207), in left arm, on 23Sep2021 as dose 3 (booster), single (Lot number: 30135BA), in left arm and on 02Apr2022 as dose 4 (booster), single (Lot number: FK9893) at the age of 62 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 12Sep2022 as dose 5 (booster), single (Lot number: FK9893), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Obesity" (unspecified if ongoing). There were no concomitant medications. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 12Sep2022, outcome "unknown", described as "dose #1: Unknown / dose #2: Pfizer / dose #3: Pfizer / dose #4 Pfizer / dose #5 Moderna"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient had no known allergies.
Received Varicella vaccine 3-4-1998. Contracted Varicella Disease 3-19-04.
Body aches, chills, sweats, fatigue, tachycardia, GI (gas, diarrhea), elevated temperature (Normal 97.1 -> 99.4) lasted for about 12 hours
Developed pruritic, rash from head to toe (minus palms and soles) on 10 April.  Then, on 12 April, in addition to his rash, his upper lip was swollen.  The rash was treated with BENADRYL and prednisone and has waxed and waned since April, but currently has resolved.  Pt began experiencing substernal chest pain accompanied by SOB on 12 April.  Pain described as "like laying on back with 10 guys on top of me".  Chest pain was constant and rated as 7/10 on pain scale.  Pain decreased when sitting straight up and flat on back, but worse when lying on either side.  No changes with deep breaths.  Dyspnea described as - "couldn't get full breath...feel winded".  Feels a little lightheaded and when experiencing dyspnea.  No radiation of chest pain.  Also began feeling fatigued around the 10 April and continues to report level of energy as 45% on scale of 0 (=bedridden) to 100 (=baseline energy level).  Chest pain treated with MOTRIN and colchicine, but pain continues.  Possible pericarditis.  6/20/08 Reviewed medical records & vax records for 4/12-6/2/2008. FINAL DX: Pericarditis Records reveal patient experienced chest tightness, exertional dyspnea, palpitations, vaccinia rash, pruitis,  x 4 days.  Seen in ER on 4/13/08.  Tx w/nsaids w/some improvement.
Following the vaccine I was slightly dizzy, after 25 minutes my chest started to get tight, had difficulty breathing, racing heart rate, some constriction in the throat.  I was taken to the ER, used Proair inhaler on the way to ER to ease breathing,  O2 sat slightly decreased but returned to normal in the ER.  Due to difficulty breathing, I had some increased anxiety which lessened after breathing became easier.  Nebulizer treatment given in the ER.  Benadryl 25mg taken.  Rash on L arm and upper chest, burning and pain in L arm.  Benadryl taken for 2 days due to returning rash and burning in arm.  Nebulizer treatments every 4 hrs on the day of the vaccine due to continued tightness and difficultly breathing.  The following day I had fatigue, slight fever, pain of 7 out of 10 in L arm, headache, neck and muscle pain.  Followed up w/ primary care physician on 12/29/2020, he advised not to take the 2nd dose of vaccine.  L arm pain lessened to 4 out of 10 on 12/30/2020.  L arm pain dissipated on 12/31/2020, but headache, neck pain and fatigue continued through 1/1/2021
within one week of receiving the first dose of Moderna on 12/23/2020, both armpits became swollen. The swelling in the right armpit appears to have subsided. the left armpit still remains swollen 41 days later. i received the second shot of Moderna on 1/20/2021.
Red area at vaccine - still have 9 days later. Itchy hot. Was more hard at beginning. Had rash/hive on hand a few hours after vaccine. Eye lash area swollen day after vaccine for 3-4 days
Significant edema of Lymph Nodes under left axillae; Significant edema of Lymph Nodes under left axillae, extreme tenderness.  Easily palpable.; This is a spontaneous report from a contactable other health care professional (patient).A 59-years-old non pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number was not reported, expiry date: not reported) an unspecified route of administration, administered in Arm Left on 24Oct2021 13:45 ( at the age of 59-years-old) as DOSE 2, SINGLE for covid-19 immunisation in pharmacy or drug store. Medical history included none. No known allergies was reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number and expiry date: not reported) via an unspecified route of administration, administered in Arm Left in Sep2021 17:30 (at age of 59 years old) as DOSE 1, SINGLE for covid-19 immunisation. Concomitant medication(s) included atenolol (ATENOLOL); famotidine (PEPCID AC); rosuvastatin calcium (CRESTOR); asa (ASA) taken for an unspecified indication, start and stop date were not reported. 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 has not been tested for COVID-19.On 26Oct2021 07:00 ,The patient experienced significant edema of lymph nodes under left axillae, extreme tenderness easily palpable. The reporter assesses the case as non serious. No treatment was received. No prolonged hospitalization was reported.The patient underwent lab tests and procedures which included BioMed: negative on 26Oct2021 Nasal Swab. The outcome of events was not recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
3 weeks after my first dose I saw a rash on my chest that appeared like chicken pox, very itchy. I also felt them on my head. I got the second dose a few days later. A week later, my chest cleared but I had patches of itchy(chicken pox like)  rashes on my arms. Then I noticed what appeared to be a similar to "heat rash" small red, itchy  bumps in patches on my obliques. As days progressed it seemed to travel to various parts of my body. Then it was my legs, followed by my buttocks, upper back, then the top of my feet. My last dose was 03/09/21. I thought it would go away by now, but it persists. My arms look like I was attacked by mosquitos and my looks like I have shingles. ( I had the 2nd shingle vaccine in Dec 2020) I have been itchy and miserable for 6 weeks now. I think it may be getting better. I do not and have not had any other issues, only pain at the injection site. I'm wondering if others have had this after the vaccine?
muscle spams, headache, tightness in shoulder , neck, right jaw, temple, no relief
Pain at injection site; stiffness; slightly warm; pain moved up my shoulder/neck area; pain moved up my shoulder/neck area; There were some hot flashes; Slight headache on rigth side; very small amount of right jaw pain that only laste a few hours; This is a spontaneous report received from a contactable consumer (patient). A 55-year-old female not pregnant patient received first dose of bnt162b2 (COMIRNATY, PFIZER-BIONTECH covid-19 vaccine, formulation: solution for injection and batch no: not reported/lot number: not reported) via an unspecified route of administration, in right arm on last Tuesday 17Aug2021 17:30 (at the age of 55-years-old) as dose 1, single for COVID-19 immunization. The patient medical history was reported as Fibromyalgia, high blood pressure and allergic to shellfish. Concomitant medications included the patient received medications within 2 weeks of vaccination included venlafaxine hydrochloride (EFFEXOR SR), tramadol, lisinopril and hydrochlorothiazide and all from an unknown date for an unspecified indication. The patient previously took levofloxacin (LEVAQUIN) and allergic to it. The patient had not received any other vaccines within 4 weeks prior to the covid vaccine. Prior to vaccination, the patient was diagnosed with covid-19 and since the vaccination, the patient has not been tested for covid-19. On 17Aug2021 at 17:45, patient reported that pain at injection site, stiffness and slightly warm, later in the day, that same pain moved up my shoulder/neck area and lasted for about 4 days. Also, it was reported that, some hot flashes that were not her regular kind and slight headache on right side, very small amount of right haw pain that only lasted a few hours. Patient underwent lab test and procedure which included SARS-CoV-2 antibody test Positive on unspecified date. The outcome of the events was recovering.   Information on the lot/batch number has been requested.
as needle was pulled out of patient, arm began to swell and bruise; turned in to a hard, hot knot
Case number PHEH2013US015500 is an initial spontaneous report received from a medical assistant on 18 Jul 2013. This report refers to a 14-year-old male patient. He received only Men CYW-135 liquid component of MENVEO (batch number: X11047) intramuscularly on 17 Jul 2013 (without being reconstituted with Men A). No adverse event was reported following medical error (inappropriate preparation of medication).
Pfizer-BioNTech COVID-19 VACCINE EUA  Pt drove up to Covid drive thru clinic for second covid vaccine. Card read first dose Moderna vaccine given. This nurse asked covid-19 patient qualification questions. Prior to administration pt confirmed first dose given was moderna. Retrieved Moderna Vaccine for second dose and administered. Documentation nurse proceeded to document and noted discrepancy in lot number and checked facility records, which records showed Pfizer vaccine was given for initial dose. Notified appropriate personnel. Pt observed for thirty minutes following administration, pharmacy consultation provided, pt left in stable condition. no immediate adverse reaction noted. Will follow up with patient regarding matter.
THE PATIENT PRESENTED WITH DIARRHEA ON AUG 11, 2209. BECAUSE OF PERSITENT DIARRHEA, PATIENT WENT TO ER AT HOSPITAL AND WAS TRANSFERRED TO ANOTHER HOSPITAL. THE PATIENT WAS WORKED UP AND REHYDRATED. ON DAY 3 OF HOSPITALIZATION,THE PATIENT HAD EMESIS AND BLOODY STOOLS. HE WAS DIAGNOSED AS HAVING INTUSSUSCEPTION AND WAS REDUCED WITH Ba ENEMA. THE PATIENT WAS DISCHARGED NEXT DAY.  9/3/09 Hospital records received DOS 8/11/09 to 8/14/2009. Assessment: Dehydration, Gastroenteritis, Intussusception. Patient was seen at outside ED, given bolus of fluids and transfered. Patient presented on the day of admission with a 2 day history of diarrhea and a one day history of vomiting. Increased output of mucosy blood-tinged stools. Decreased PO intake and urine output, not producing tears, pale. Lethargic. Belly distended and tender. Reduction of intussusception with barium enema.  ICD-9 Codes: 276.51 Dehydration, 558.9Y Gastroenteritis, 560.0 Intussusception.
This was my 2nd dose of SHINGRIX. I waited the required minimum of 2 months for the second dosage. Woke up in the middle of the night sweating & nausea. I was super fatigued for the next 2 days. I had what I would describe as flu like symptoms. Saturday afternoon I felt extreme fatigue & got the worst case of chilis I have ever had. I felt more weakness all the way through Tuesday July 10th. I still feel somewhat washed out where normally I have super high energy.
After the vaccination in the morning, Sa-04-17-2021, have been in Urgent Care in the afternoon for an ongoing kidney stones issue that had occurred earlier this week. Felt tightness and pain in both lower legs which continued the next day, and it became worse.  Mentioned this issue to the primary physician the following Monday 04-19-2021, but predominance had been given to the Kidney stones issue. On 04-26-2021 mentioned again the pain predominantly in the left calf to the primary physician.  The same day, blood clots were found in both lower legs by Urgent Care. Had received information for Deep Vein Thrombosis by physician who prescribed Lovenox (enoxaparin) injections and advised to report the findings to V-safe. Continued narrative: Being informed by Urgent Care on 04-30-2021 that blood clots were not only in both lower legs, but also in both upper legs, now, after complaining about more pain. Ultrasound checks.  Being advised to move and rest moderately.  Received again information about Deep Vein Thrombosis.  Advised to consider to skip the second Pfizer vaccination. Being on sick leave since 04-13-2021.  Had switched from Lovenox to Pradaxa per prescription starting from Sa-05-01-2021. Urgent Care, 05-03-2021 conducted another ultrasound check.  Another blood clot had developed.  Again advised to consider to skip the second Pfizer vaccination, on SA-05-08-2021, to avoid more complications and risks.  Under continued observation. Being alerted that this condition can lead to permanent damage and can turn life-threatening. Continued sick leave, considering medical leave.  Concerned about the decision to take the second Pfizer vaccination, on Sa-05-08-2021.
Achy neck; Stiff neck; Monocyte was high; Diarrhea; Passed out; Very dizzy; Chills; Headache; Fatigue; Walking across a room takes breath out; Lightheaded; A spontaneous report was received from a consumer, who was a 29-year-old female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced the events, passed out, very dizzy, lightheaded, fatigue, walking across a room takes breath out, headache, chills, diarrhea, monocyte was high, and stiff and achy neck.   The patient's medical history was not provided.  Concomitant product use included acetylsalicylic acid.  On 31 Dec 2020, approximately one day prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the right arm for prophylaxis of COVID-19 infection.  During the morning hours of 01 Jan 2021, the patient passed out, felt dizzy, lightheaded, fatigued, had a headache, and chills. The patient reported that walking across a room took the breath out of her.    On 02 Jan 2021 the patient experienced diarrhea in the evening.   On 03 Jan 2021 the patient presented to the emergency room but was not admitted. Her monocyte count was high, but other lab results were normal.  Her headache was treated with anti-migraine medication intravenously.  She stated she was still experiencing dizziness and her neck was still achy and stiff.  No additional treatment information was provided.  Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the events, passed out, lightheaded, fatigue, walking across a room takes breath out, headache, chills, diarrhea, and monocyte was high, was unknown.  The events, dizziness and stiff and achy neck, were considered not resolved.; Reporter's Comments: This case concerns a 29-year-old female patient  with unknown medical history, who received their first of two planned doses of mRNA-1273 (Lot 0371C20A), and who experienced the serious unlisted event of Syncope, the non-serious listed events of diarrhea, chills, headache, and fatigue, and the non-serious unlisted events of Dizziness, Monocyte count increased, Musculoskeletal stiffness, Dizziness (lightheadedness), Neck pain, and Dyspnoea.  Based on the current available information and temporal association between the use of the product and the onset of the events on the day after vaccination, a causal relationship cannot be excluded and the events are considered possibly related to the vaccine.  The events may be explained by an undiagnosed viral illness based on the constellation of symptoms and elevated monocyte count.
Severe exacerbation of tinnitus. This also happened after his previous dose but less severe. Can't hear out of his left ear.
Fever started 6th day post vaccination. Fever was 103 deg. F. on the 8th day post vaccination and 104 deg. F on the 9th day. Rash started on the 10th day. Gastrointestinal symptoms started on the 11th day post vaccination.
Starting today on the left arm in the area of the vaccine, it is red, swollen, feels hot and there are small bumps on his shoulder where he received it.   It is localized to that area.
48 hr pt has been having fever, chills, fussy, unable to sleep well lethargic when awake, anorexia; had checkups 25JUL95 & MD said it was a pertussis rxn; fever up to 104.5, now @ 101.5 p/48 hr;
Shortness of breath, cough, chills, body aches, fatigue, nausea, diarrhea, and positive covid test several months post vaccine
Information has been received from a RN concerning a 38 month old white male who in the morning of 18Mar03 was vaccinated in the left deltoid with the first dose of varicella virus vaccine live (lot 643129/0570M). Concomitant vaccinations on that same day and time included the third dose in the right deltoid of pneumococcal 4 6B 9V 18C 19F 23F conj vaccine (crm197) (Prevnar) (lot 491185). The RN reported that on 17Mar04, the pt presented to the physician's office with a rash and an upper respiratory infection characterized by congestion. The pt was noted to be afebrile. A diagnosis of breakthrough was made. The pt was treated with acetaminophen (Tylenol), ibuprofen (Motrin) and increased fluids. Subsequently, the pt recovered from the URI and breakthrough and was noted to be doing well. The RN also reported that two of the pt's brothers developed breakthrough after being vaccinated with varicella virus vaccine live (WAES0406USA02067 and 0406USA02727). Additional information is not expected.
I only know the vaccine to be "AIIV4" influenza vaccine, so I guessed at "affluvial."  I tried to get out of bed the following morning (Oct 15), but had to lie back down quickly because of very strong vertigo.  I had no sense of balance at all and the only thing I could do was fall back onto the be.  After the initial bout of vertigo, I got up very slowly  and was okay to be proceed with my day after a few minutes.  Similar issue occurred the next morning  (Oct 16) but not quite as bad and issues resolved within a half minute or so.   Thereafter, I had no further vertigo issues.  I had not had vertigo before this event and none since.  I had not had vertigo before this
soreness at the injection site; This case was reported by a consumer via interactive digital media and described the occurrence of injection site pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, several days after receiving Shingles vaccine, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingles vaccine.  Additional details were reported as follows: The age at the vaccination was not reported. The patient reported that received Shingles vaccine. Patient informed had soreness at the injection site for a few days. The reporter reported his/her friend got shingles and was not going to get the shots after they finally went away but after dealing with all the severe pain he ended up getting the shots, he decided he wasn't as tough as he thought he was. The case had been linked with US2021AMR241060 reported for the same patient for another dose of Shingles vaccine.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR241060:same reporter
The next day left upper arm where Varicella was administered was red and swollen.  Resolved by 72 hours
On 01/11/2022 I went to a drive thru to get a PCR COVID-19 test and the results came back positive on 01/18/2022.  My husband was not feeling well and he had a real bad cough, that is what initiated going to get the test on 01/11/2022. On  01/17/2022 I woke up like I was getting a cold, no energy, a cough, not a deep cough, but persistent, a bit of a headache, just felt crummy, never had a fever, the fatigue got worse. I did not feel like doing anything. I just napped a lot during the day. Did not lose my appetite at all or my sense of smell. I talked to my doctor over the phone,  he ordered antibiotics, steroids and a chest x-ray. I have finished my drug therapy. Because I was boosted, I feel it made my COVID-19  symptoms lighter. If there is another booster, I would step up and take it.
PATIENT CALLED AT 9AM 2/17 NUMBNESS TO FINGERS, VEINS IN HANDS EXPOSED AND SWOLLEN. BURNING SENSATION TO HANDS. REDNESS TO  UPPER LEFT ARM.
Large ethrematous, tender & warm patch to the left upper arm. Prednisone & cephalexin ordered prescribed
Stomach hurting, pale, clammy, nauseous, vomiting, chills, weak, vomiting.
This spontaneous report as received from a pharmacist who stated that a nurse called him and said she had administered expired ROTATEQ, 2ml oral (lot#H015682), to an infant today (21-MAR-2014). The expiration date was 18-MAR-2014. No adverse effects were noted to the infant. No treatment was given for the infant. The patient did not seek medical attention. Additional information has been requested.
Artery/vein pinching and pulsing, muscle pain, fever, nausea, joint pain, chills, weakness.
Awakened 4 times shivering, Headache- relieved with 1 gram of Tylenol.  dizziness- resolved 3-4 hours after waking.  Fatigue- slept for 13 hours after working Body aches (mainly lower extremities)- worsened above movement. Dull ache while at rest. resolved with time.  Hot flashes- random hot flash with sweating. Still experiencing almost 48 hours after immunization.
Paresthesias on right thigh. Feels like pins and needles or a cold ice pack applied and sensation moves from hip down to knee. Repeats multiple times daily everyday since vaccination. Occasional tingling and weakness in forearms and wrists bilaterally.
This spontaneous report as received from a nurse refers to a multiple unspecified patient of unknown age and gender. The patient's concomitant therapies, medical history and concurrent conditions were not provided. On 22-SEP-2015, the patients were vaccinated with improperly stored doses of (Merck) PROQUAD injection, lot # L010143, expiration date 24-SEP-2016 (does and route of administration were not reported). No adverse effects were reported. This is one of the two reports from the same reporter. Additional information has been requested.
Moderna Covid-19 Vaccine EUA Two days after injection the itching began at injection site.   One week after injection, redness occurred at the injection site and has worsened for two days.  It is now approximately 3 inches in diameter.  The itching continues.  Client reports a "hard spot the size of a quarter" near the injection site also.  The client did not sign up for V-safe.
Approximately 5 hours after receiving flu vaccine mother noticed a rash on face extending to legs and back.  Also lip itchiness.