chrisvoncsefalvay/vaers-outcomes huggingface dataset:
their neck and their upper arm were also affected; palpable left axillary lymph nodes; the swelling had reached the left supraclavicular; axillary tenderness; body ache; chills; fever; headache; joint pain; This spontaneous case was reported by a physician and describes the occurrence of CHILLS (chills), PYREXIA (fever), HEADACHE (headache), ARTHRALGIA (joint pain) and LYMPHADENOPATHY (palpable left axillary lymph nodes) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J202A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Autoimmune disorder NOS. Concomitant products included MONTELUKAST SODIUM (SINGULAIR), FEXOFENADINE HYDROCHLORIDE (ALLEGRA), PEPSIN and DICLOFENAC SODIUM (VOLTAREN EX).    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced CHILLS (chills), PYREXIA (fever), HEADACHE (headache), ARTHRALGIA (joint pain) and PAIN (body ache). On 21-Jan-2021, the patient experienced AXILLARY PAIN (axillary tenderness). On 22-Jan-2021, the patient experienced LYMPHADENOPATHY (palpable left axillary lymph nodes) and SWELLING (the swelling had reached the left supraclavicular). On 24-Jan-2021, the patient experienced PERIPHERAL SWELLING (their neck and their upper arm were also affected). On 18-Jan-2021, ARTHRALGIA (joint pain) and PAIN (body ache) had resolved. On 29-Jan-2021, PYREXIA (fever) had resolved. At the time of the report, CHILLS (chills), HEADACHE (headache), LYMPHADENOPATHY (palpable left axillary lymph nodes), AXILLARY PAIN (axillary tenderness), SWELLING (the swelling had reached the left supraclavicular) and PERIPHERAL SWELLING (their neck and their upper arm were also affected) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment of these events included ibuprofen and acetaminophen.
Vaccine administered beyond use  date of the  product by a handful of days.  No  adverse effects reported
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: pt had a brief blackout, fainted-Severe, Additional Details: Patient stated he didn't like needles so he looked away, I gave the flu shot he was fine, but then after the Moderna shot, he went pale and fainted...and he went to sit but he slowly fell on the floor, he came to after about a minute and was able to sit in the chair.
Inflammation, swelling of (R) thigh treatment with antibiotics, diphenhydramine and ibuprofen.
103+ degree fever Chills Body aches Lethargy  Lasted about 12 hours Took 925 mg Tylenol
Lips swelled and i broke out in a rash from my stomach all the way down my legs and feet
extreme constant throbbing headache to my right side and back of head. Never had a headache like this before. Position of head, neck movement does not make a difference. Tooke 600 mg of ibuprofen and only helps about 20%. Headache has not progress and stay the same on 05/01/21. 05/02/21, 05/03/21, 05/04/21. Felt better 05/04/21 around 10 pm. 05/05/21 headache has decrease in intensity. No other symptoms
Moderna COVID?19 Vaccine EUA (2nd Shot) Skin rash at the area of the shot (left arm). Appeared maybe a day later as mildly itchy. Approximately 8 days later and the skin rash is now visible and slightly discolored. Still only mildly itchy. Only some discomfort from having to itch. No other adverse outcomes from this shot..
hives, swelling of upper lip, localized to one area.  No SOB, no throat swelling.  Observed for additional 20 minutes and 1 dose (12.5 mg) of Benadryl given.  Some improvement noted.  Patient advised to call 911 if symptoms worsen.  Will need 30 minutes of observation for second dose.
Swelling eyelids and rashes on body started occurring on a daily basis after vaccination. Thyroid antibodies detected and autoimmune thyroid disease diagnosed. Later on autoimmune urticaria finally diagnosed too.
lt arm warm to touch, swollen top of arm;twenty five cent size reddened area;cool compress to site, APAP, to circle area to check if any addtl spreading;
05/01/06 immunizations given no problems 5/2/06 noticed red, warmth and swelling gave Tylenol and bath 5/3/06, came to PCP no fever, redness per mom increased, no fatigue, fussiness. Next office visit 5/5/06.
After receiving vaccine pt stood up and moved aside for sibling to receive the vaccine also.  After sibling received vaccine, pt had syncopy event.
pt states abd pain/achy & nausea;informed pain not unusual rxn;advised fluids, rest-PRN APAP;states resolution of most sx;states cont upper body achiness and headache;
still feeling a tenderness today at the injection site; could barely make it to the bathroom; vaccination site on his left arm was the size of a half dollar or golf ball/left arm was swollen; vaccination site / was bright red almost like a brown recluse bite/ red- LLT erythema of extremities; he was lethargic and he went to bed; was so tired; arm was really hot/ His normal body temperature is around 97.8 and it was 99 / his temperature went to 101.1; Soreness; This case was reported by a consumer and described the occurrence of swelling arm in a 56-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included hand operation (due to Dupuytrens performed on 21st Dec 2020). Previously administered products included Testosterone and Shingrix with an associated reaction of injection site pain (1st dose received in October 2020, for tolerance refer case US2021034609). Concurrent medical conditions included hiv infection.   On 5th February 2021, the patient received the 2nd dose of Shingrix (intramuscular). On 5th February 2021, less than a day after receiving Shingrix, the patient experienced swelling arm, erythema of extremities and lethargy. On 6th February 2021, the patient experienced injection site tenderness and mobility decreased. In February 2021, the patient experienced fever, fatigue and pain. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the swelling arm, injection site tenderness, erythema of extremities, fever, lethargy, fatigue, mobility decreased and pain were unknown.   It was unknown if the reporter considered the swelling arm, injection site tenderness, erythema of extremities, fever, lethargy, fatigue, mobility decreased and pain to be related to Shingrix.  Additional details were provided as follows: The patient had reported the case for himself. The patient received shingrix in  left arm.. The patient had the vaccination between 11:30 AM and 1:00 PM and by 9:00 PM, his left arm was red and swollen and he was lethargic and went to bed. The patient when woke up, was so tired and his arm was really hot. His normal body temperature was around 97.8 F and it was 99 F raised to 101.1F by the next day.  The vaccination site on his left arm was bright red almost like a brown recluse bite.  The next day, he felt tenderness at the injection site but on that day and Sunday, he could barely make it to the bathroom. The patient was well and had blood pressure in the normal range of 122 by 82. The reporter consented to follow up. ; Sender's Comments:  US-GLAXOSMITHKLINE-US2021034609:Same reporter
administered expired doses; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered expired doses) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered expired doses). On 07-Sep-2021, EXPIRED PRODUCT ADMINISTERED (administered expired doses) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided by reporter.  Treatment information was not provided by reporter.   This case was linked to MOD-2021-314573, MOD-2021-314570.   Most recent FOLLOW-UP information incorporated above includes: On 10-Sep-2021: Start date of drug, event and batch number were updated. On 15-Sep-2021: Possible NNI.
About 12-13 minutes into my wait after getting the vaccination... my throat had a tickle in it... like I needed to clear my throat.  So I did... and then again.... and again.    Then I felt dizzy and disoriented... foggy headed kind of drunk feeling.    Then within what seemed like seconds... my mouth felt full so I opened my mouth and looked in the mirror.   My tongue seemed bigger than usual and lighter in color.  But what was most noticeable was that I had Ripples along the whole outer edge and side of my tongue.    pulse ox reading was an 89 so they administered a prescription strength Benadryl shot and told me they would need to monitor me and keep an eye on me.  Another woman drove me from the vaccination site to the clinic where they checked my oxygen levels again and i was already back up to 99.  They monitored me and checked on me for about 15-20 minutes before releasing me.  My tongue finally felt normal again about 2 hours later while resting at home.
after she received the initial dose, her ankle swelled.; wasn''t feeling the same; constipation; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 25Jun2021 (Lot number: EN0168) at the age of 53 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Pericarditis" (unspecified if ongoing), notes: Verbatim: Pericarditis, Had pericarditis when she was 21 years old; "Blood cholesterol increased" (unspecified if ongoing), notes: Verbatim: High cholesterol, diagnosed maybe 3 years ago and she was put on a statin; "Chronic anxiety" (unspecified if ongoing); "Depression" (unspecified if ongoing); "chronic mastoiditis." (unspecified if ongoing). There were no concomitant medications. The following information was reported: JOINT SWELLING (non-serious) with onset 26Jun2021, outcome "not recovered", described as "after she received the initial dose, her ankle swelled."; FEELING ABNORMAL (non-serious) with onset Jun2021, outcome "not recovered", described as "wasn''t feeling the same"; CONSTIPATION (non-serious) with onset Jun2021, outcome "not recovered", described as "constipation". The events "after she received the initial dose, her ankle swelled.", "wasn''t feeling the same" and "constipation" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible. No further information is expected.
Moderna COVID-19 Vaccine EUA Itching, swelling, and redness for 18hours so far.
1/17/22 pt to ED for worsening SOB; found to be positive for COVID; supplemental O2 given; admitted; eventually required BiPAP; family decided on hospice care for pt; pt had inhospital hospice; he passed away in the hospital
I had my first vaccination on 1/11/21 at HD. The reaction was typical- significantly sore red inflammed arm over deltoid muscle that resolved after 3 days. Second dose given 21 days later- some swelling and soreness, low grade fever. Then 3 days later, I awoke, turned in bed and experienced an intense shearing pain in my neck and arm. The pain was the worst ever felt, and was not improved with NSAIDS, Acetaminophen, Hydrocodone, or Tramadol. I went to an urgent care center on 1/16 where a tentative diagnosis of sprained neck was made. The sypmptoms continue with slight improvement with steroids, and a muscle relaxant. I am concerned because I understand that covid itself can impact the nervous system considerably.  I am awaiting improvement in symptoms and if none seen then I will see my primary care MD
Developed erythema multiforme rash on body - temp 100 F - spread rapidly to hands, feet, back of head, face, torso, groin. Had been on clindamycin - finished 2 days ago. Immunizations given 6/1/2010.
PT DEVELOPED SOME SHAKINT FOLLOWING IMMUN.CHILD HAD HIGH FEVER-OTHERWISE OK. VIAL CONTAINED SEDIMENT.
unusual ashma attack lasting couple days; Believed was my allergy or asthma; silly cough that disappeared after couple hrs/2nd vac cough came back following day, got really bad.; Believed was my allergy or asthma; 2nd vac cough came back following day, got really bad. Blieved was my allergy or asthma; breathing was very agitated; This is a spontaneous report from a contactable consumer (patient). A 62-years-old female patient reported for herself that she received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in arm left on 29Mar2021 at 07:30 AM (age at vaccination was 62 years) as DOSE 2, SINGLE for covid-19 immunisation. The patient was not pregnant at the time of vaccination. No other vaccines were received within four weeks prior to the administration of bnt162b2. Medical history included high blood pressure, borderline diabetic; both from an unknown date and unknown if ongoing. Concomitant medications included levothyroxine, losartan, metformin, atorvastatin [Atorvastatin]; all taken within two weeks for an unspecified indication, start and stop date were not reported. The patient previously received bnt162b2 (Batch/Lot number was not reported), via an unspecified route of administration, administered in arm left on 08Mar2021 at 04:45 PM as DOSE 1, SINGLE for covid-19 immunisation and experienced silly cough that disappeared after couple hrs, between 1& 2 the patient unusual had asthma attack lasting couple days. Reported stated that, on 30Mar2021 at 08:00 PM, on 1 & 2 dose the patient had had silly cough that disappeared after couple hrs, between 1 & 2 she unusual had asthma attack lasting couple days. Second vaccination cough came back following day, it got really bad. The patient believed it was her allergy or asthma, treated it but got worst to the point that yesterday she had to go for treatment at MD, because breathing was very agitated and didn't suffer for any type of such extreme asthma. The patient went on the 29Mar2021 for the second dose with no allergies, no asthma, no cough, no nothing, her body was cleared of any kind of symptoms, was not exposed to anything that could start that cough. The patient believed that without doubt the non stop cough appeared after the shot, she was not a doctor but knew how to treat her allergies and asthma that were seasonal, that had been something completely different out of nothing that had happened to her before, to the point that she had to seek professional help more than 2 was after shot. Adverse events resulted in visit to emergency room/department or urgent care. Therapeutic measures were taken as a result of the events. Treatment included steroid injection, antibiotic, prednisone cough suppressant. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not tested for COVID-19. Outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
A short while after I (pharmacist) administered his vaccine, I was concerned that I might have given him 0.6 ml instead of 0.3 ml dose.  I was unsure. If I did give him 0.6ml, it would be double the dose.  I researched information about this and called the patient and explained what I found out.  I found out that higher doses were given in some trials, but it was decided to ultimately reduce the dose to 0.3 ml when vaccine released to the general population.  I also found out that patients who had received the whole stock vial undiluted were unharmed.  I found out that he could possibly have more of the common reactions to the vaccine if his dose was 0.6 mls, but he would not be in danger.  I explained this all to the patient. I spoke to him by phone on 9/8/21 at 11:10 am.  He stated that he was not having any ill effects to report.
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Other HCP) for a Pfizer sponsored program.  A 56 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 56 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Esophageal reflux" (unspecified if ongoing); "Gastritis" (unspecified if ongoing). Concomitant medication(s) included: VITAMIN D3; VITAMIN B-12; PROGESTERONE; FLUAD QUAD. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 08Jan2022, outcome "unknown" and all described as "COVID-19". Clinical course: The patient had no known drug Allergies. Patient has medication on hand, Missed 3 weeks of medication due to covid 08Jan2022. Withheld is aware and pt is now back on the medication. The patient medication were Vitamin D3, Vitamin B-12, Progesterone, Pfizer Covid-19 Vaccine, Fluad, Daily-Vite.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Received second dose of Moderna COVID vaccine on 7/2/21. 7/3 developed fatigue, dizziness, and decreased hearing. Symptoms progressed to difficulty breathing and chest pain. 7/4 chest pain localized to left side of chest. He was seen in local ED with elevated troponin of 8154, EKG with diffuse ST segment elevation. Transferred to another ED for further evaluation. He received IVIG on 7/5 and did develop V-tach lasting about 7 beats around 0500 on 7/5 but otherwise hemodynamically stable.
10 Days post vaccine right arm injection site became itchy, warm to touch and swollen distal to site. Pt took Ibrupfen X2 and applied Benadryl cream to site. By 05/13/2002, symptoms were resolving. Dr. thought possibly cellulitis.
Approximately 1.5 weeks from second shot, began experience dizziness and numbness in arms and legs. These spells lasted for a couple of hours but after a few days became more chronic and was matched with fatigue, tightness of chest, headaches, and brain fog.  Impaired ability to complete every day tasks. Began presenting with capilliarities in mid April, along with easy bruising/bleeding and elevated liver enzymes (the enzymes began to stabilize over the following week).  All of these symptoms have persisted (currently May 4th).
Pt had severe anxiety and claustrophobia prior to vaccine. Immediately following administration patient went limp/fainted, awoke seconds later was nauseous and vomited slightly. Patient was pale. Asked patients mother if he had eaten today he had not. Provided patient with a iced tea he brought with him. Upon sitting, monitoring temp, talking with patient and mom, patients color returned and patient was feeling better. Patient remained seated for approximately 30 minutes and upon leaving patient was feeling much better.
pt inadvertently recv 5ml of TD vax instead of 0.5ml;that evening the arm of inj began to hurt & bleed;pt also exp nausea & vomiting;by the next day the pt c/o feeling cold & feverish & had a h/a;arm became hard,red & had red lines;nervous
Ringing in the Ears started about one month after the 2nd does. Had appt with Ear Dr on 5/6/2021 and hearing test on 5/7/2021. Slight hearing loss in left ear. Report back in a year for another test or call if symtoms get worse.
Pt. said the injection started hurting immediately and within the hour her arm was very swollen, blood red, throbbing, hot/feverish. It took 2 wks for symptoms to resolve.
Onset of episodes of l hand rash or pounding. No palpitation. No headache. No flushing. Vision. No vertigo. No out-of-body experience. Lasted <60 seconds every 3-4 hrs She was unsteady sitting when it occurred. Easing up as of 1/7/21 but still occurring at least 2x/day. Now SOB better
Fatigue, dizziness, generalized aches, small headache. Tops of feet painful & throbbing. Also had ligament repair in right hip for which I am going to physical therapy. Three incision sites are throbbing/burning.
12/29/20 came to vaccine clinic to report.  states had vaccine 7:10 pm, waited 15 minutes, 'felt edgy' but thought maybe nerves.  7:25 pm walked back to her office, felt slightly lightheaded, had worked 12 hours, sx subsided.  7:45 pm walked to her car felt right side jawline numbness that extended to forehead and whole side of face, able to smile, swallow, drove home (30 min) and sx stayed the same.  states lingered over the evening, went away by 10 pm.  states eyelid felt heavy, was not puffy.  did not keep her awake - did report night sweats.  0700 awoke, states no sx, no residual.  states arm slightly sore and general joint aches.  1205 came to clinic to report.  states feels pretty good, concern is about next shot.  Will contact PCP, did vsafe and will complete report.
Per Dad pt received H1N1 nasal vaccine on 10-30-2009 1-1.5 weeks later was in Er with nausea, abd pain and body aches.  Recieved IV fluids, blood work, and a CT scan which were negative and pt was discharged.  Saw family physician and symptoms continued hospitalized for two days symptoms continued developed vomiting/still had abdominal pain test negative.  Saw gastroenterologist, vomiting continued endoscopy done had ulcers all along esophagus and a stomach ulcer.  Abd pain continues, vomiting mucous with blood. Discharged.  Did another second endoscopy states ulcers healing.  Abdominal pain persists.  Was again seen in Er 12/15/2009, blood work negative and xray negative.  Has colonoscopy scheduled for 12-18-2009.  Nausea and abdominal pain continues.  Dad said H. pylori was ruled out. 12/16/09 Update report information to include: 1) Treatment received at hospital. For additional records - endoscopy procedure. Pt developed lower quadrant abdominal pain. Will have colonoscopy procedure on 12-18-09.
Patient reports arm pain starting in shoulder down to bicep. Starting at time of vaccination and continuing until at least 10/25 with no improvement and no relief with medications/therapies. Reports cannot lift arm above head.
Patient was accidentally given  non-diluted dose (.2ml) of Pfizer covid vaccine (basically 10 doses total) in one leg during appointment today.  Patient was also given MMR, Varicella, and Hep A in the other leg.  This was their first covid shot.
25JUL98 tenderness noted @ site of inj, fever, blotches, & throat felt tight & constricted;these sx lasted through 26JUL98;knot @ inj site & more painful to touch;27JUL98 other sx cleared x/inj site more swollen (size 80mm) & painful
Patient receieved Moderna COVID-19 hospitalized for salmonella and norovirus. Received levofloaxin and IV fluids. Discharged to home medically stable.