chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Blisters with weeping serous fluid on the shin in the L4/5 dermatome distribution with pain, pruritus, and redness.
After approximately 12 hours of receiving the second dose of Moderna COVID19 vaccine, I began to feel ill with headache and dizziness and fatigue.  Within the next hour or so, I lost the ability to move my left leg at all.  I could not pick up my leg, reposition my leg, move my toes or move my foot.  It was though it was completely paralyzed.  By 9:00 the next morning, I had some ability to move my left leg, but I still could not bear weight nor lift my leg independently.  As the day progressed, I gained more mobility back and by 9:00am the following day (48 hours post injection), my mobility had returned to normal.
Client stated that the injection of the vaccine stung and shortly after his arm began to itch and feel tingly. Nurse applied an ice pack to site and gave client 25mg benadryl the injection site was also red at this time. About 5 min after Benadryl was taken, client stated that itchiness had improved. Denied shortness of breath, and dizziness. Nurse observed that redness of site was improved. Client released to leave via personal vehicle by RN.
pt recv vax; forearm, hand, and fingers felt numb and tingly; sx subsided but mobility of arm to reach across chest,behind back cause discomfort; aches at noc;there has been no change in discomfort
Fever; Chills; Body aches; Headache; An other vaccine was received on same date 28Apr2021; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot/batch number and expiration date not reported), via an unspecified route of administration on 28Apr2021 (at the age of 42-year-old) at single dose for COVID-19 immunisation. An other vaccine was received on same date 28Apr2021. The patient's medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 28Apr2021, the patient experienced fever, chills, body aches and headache. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events was unknown. This report was reported as non-serious by reporter.  Information about lot/batch number cannot be obtained. No further information expected.  Amendment: This follow-up report is being submitted to amend previously reported information: event Product use for unapproved combination added since 'An other vaccine was received on same date 28Apr2021'.
NO ADVERSE INC0.15MGIDENT. GAVE ONLY 1/2 OF PRESCRIBED DOSE (0.15MG INSTEAD OF 0.3MG). PREDILUTED VACCINE WAS DILUTED WITH NORMAL SALINE.
This is a spontaneous report from a contactable physician and from Pfizer Consumer Healthcare for a contactable Pfizer sales representative. This contactable physician reported different events with the same suspect product for four patients. This is the first of four reports. A 68-year-old male patient (weight 112 kg, height 173 cm) received PREVNAR 13 (lot number J67644, expiry date Mar2016) on 02Jan2015 at 09:00, intramuscular in left deltoid, at 0.5 ml single dose. The patient had no medical history. Concomitant medications were not provided. Past drug event included drug allergy due to erythromycin ethylsuccinate (EES), sulfa, SINGULAIR, and lisinopril. The patient experienced swollen arm and redness on 03Jan2015. The events required doctor visit on 16Jan2015. No other vaccinations were given within eight weeks prior to the events. Relevant tests were none. The patient was not recovered from the events at time of report. The Pfizer sales representative mentioned that the doctor believed that the reactions were experienced by the patient because of the PREVNAR 13. Follow-up (23Jan2015): New information from Pfizer Consumer Healthcare for a contactable Pfizer sales representative includes causality assessment. Follow-up (18Feb2015): New information reported from the contactable physician includes: past drug event. Follow-up attempts completed. No further information expected.
headache; feeling like having a temperature; was not high and it was 95; felt like tired; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number, expiry date were unknown) via an unspecified route of administration on 31Dec2020 at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. On 01Jan2021 almost like 11 o'clock, the patient started with headache and was feeling like having a temperature but when checked, temperature was not high and it was 95, the patient felt like tired. The patient stated "I remember they said after you put in this, this is may be what happen. So, is it still in there is it still, so my question is can I take a some medicine or I need to wait till later with no medicine." The outcome of the events headache, body temperature decreased, fatigue was unknown.  Follow-up activities are possible, information on the batch number has been requested.
a 15 months old female patient was administered a dose of Daptacel on 18-Feb-2020, before realizing the vaccine was expired on 30-Jan-2020/No AE; Initial information received on 18-Feb-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 15 months old female patient who was administered a 0.5ml fourth dose of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] on 18-Feb-2020, before realizing the vaccine was expired on 30-Jan-2020 (lot C5367AA) via intramuscular route in the left thigh for prophylactic vaccination.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HIB VACCINE CONJ (TET TOX) (ACTHIB).  It was an actual medication error due to expired vaccine used.  At the time of report, no adverse event was 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.
Staff at facility informed  staff that a staff member had passed out.  RN from drug store found client sitting in a chair, awake and alert, no signs of injury.  Had client lay down and elevated legs.  BP at 1:50 PM is 122/86, HR is 100, regular and strong, color is good, mentation is good, no signs of injury, client state she feels "weird and tingling".  Patinet monitored for over 30 minutes with multiple BP and HR checks and mentation checks.  One dose of Bendaryl 25 mg given at 1:57 PM.  Orthostatics completed at 2:00 PM.  Both HR and BP remain WNL and client continjues to be awake and alert,.  Ambulated to bathroom with RN at side.  Patient declines need for EMT and went home with her boyfriend at 2:20 PM,  BP at 132/88, HR at 80.
Anaphylactic Shock; The patient looked weak; This spontaneous report was received from a pharmacist concerning to a 70 year old male patient with diabetes mellitus and prostate issues (reported as might have prostate issues). Medical history and concurrent conditions were not provided.  On 30-SEP-2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23), 1 dosage form intramuscularly, lot# S018405, the expiration date of 28-MAR-2021, for prophylaxis (reported as vaccination).  Other suspect therapies included an unspecified flu vaccine (reported as flu shot); dose, route, lot# and the expiration date were not reported also for prophylaxis.      On the same date, the patient developed an anaphylactic shock right after administration of the unspecified flu vaccine and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (interval between both vaccines was about 3-4 minutes). The pharmacist stated that he gave the patient epinephrine hydrochloride (EPIPEN) as treatment right away and the patient recovered from the event right away. However, the patient looked weak (asthenia), so the pharmacist called an ambulance to take the patient to an unspecified hospital. At the time of reporting it was unknown per pharmacist if the patient would be admitted to the hospital.  By the time of the report, the outcome of asthenia was unknown. The relatedness between the events and the pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) and unspecified flu vaccine was unknown.  Upon internal review, the anaphylactic shock was determined to be medically significant.
My entire legs (both, but mostly the left) will cramp anywhere from hip to toe, 4-8 times a night. Sometmes it's the whole leg, but it normally jumps around from side of foot or hamstring or shin or calf or toes or anywhere. Normal standing and stretching doesn't work effectively. I have found nothing that will make the cramps go aways immediately. It takes me usssually 30 minutes of stretching an rubbing to get the cramps to reside enough to go back to bed. The cramping has been constant since the first of April (4 months now). My doctor has had me try muscle relaxers with no help. He's had me back of on certain meds. I've had blood work and magnesium and potaWssum is normal. I'm staying hydrated, drank pickle juic
This spontaneous report as received from registered nurse refers to a 15 year old female patient, with none pertinent medical history. On 16-OCT-2012, the patient was vaccinated with a dose of VARIVAX (Merck) (Lot # H006536, exp date 09-MAR-2014) (dose and route not reported). Other suspect therapies included sterile diluent that was used to reconstitute the VARIVAX (Merck) (Lot # 6104Y, exp date February 2012). There was no concomitant therapy. On 18-OCT-2012, the patient's mother reported that the vaccine site was swollen to the size of a grapefruit, warm and hard to the touch. The patient was examined by an unspecified physician on 19-OCT-2012 and 27-OCT-2012. The nurse stated that the unspecified physician stated the adverse symptoms were not an infection and they were probably the result of a bruised muscle. The nurse reported that the VARIVAX (Merck) that was administered was reconstituted with sterile diluent that had expired on an unspecified date in February 2012. No treatment was given for the adverse events. Laboratory diagnostic studies were not performed. It was reported that the patient recovered from the adverse events on 07-NOV-2012. Additional information has been requested.
systemic fever, rigor, severe local reaction with edema, heat, pain, induration of entire upper arm, wife got identical reaction from same vial.
This is from where the member started doing his onw VAERS report:  Flu shot taken approx. 1400 hours Sat 6 Nov 2010, at 1800 hours noticed soar throat pains. Sunday 0800 hours 7 Nov 2010 noticed visible rash on chest and under right arm(itchy rash). Reported to sick call 0730 Tues 9 Nov 2010 and diagnosed with Shingles per the physician Dr. Memeber reported to the clinic on the 15th for some medication to aid in his recovery. Member reported to the Medical Office today at 10 AM stating what has occuered since drilll.  //SIGNED//  Public Health Technician
Pt had a low grade fever, vomiting, large red induration on (R) thigh at injection site.
Pt recvd vax & 4 hrs post 3rd inject pt devel serum sickness, tachycardia, hypoxia, & fever of 105;
Pfizer-BioNTech COVID-19 vaccine: Extremely sorry injection site, chills, sweating, body aches, stuffy nose, headache,  feeling "foggy".
During an inventory count on 8/8/23, it was discovered that a patient was only given the liquid part of the Pentacel Vaccine (Dtap/IPV/Hib).  The liquid part contains the Dtap/IPV, this is to be mixed with a separate vial of powdered Hib. We were able to trace back the lot number and were able to identify who the patient was that this happened to.   A call was placed to the manufacturer on 8/14/23 and it was noted that the Dtap and IPV will count as doses, but that the Hib will need to be redone.   Parents will be called and notified of the error.
Low grade fever; Shaking; Tremors; Fever to 102 F; Chills; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Shaking), TREMOR (Tremors), PYREXIA (Fever to 102 F), CHILLS (Chills) and PYREXIA (Low grade fever) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     No Medical History was reported.  Concomitant products included SIMVASTATIN, ASCORBIC ACID, BETACAROTENE, COPPER, NICOTINAMIDE, SELENIUM, TOCOPHEROL, XANTOFYL, ZINC (LUTEIN +) and CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) for an unknown indication.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Mar-2021, the patient experienced TREMOR (Shaking), TREMOR (Tremors), PYREXIA (Fever to 102 F) and CHILLS (Chills). On 25-Mar-2021, the patient experienced PYREXIA (Low grade fever). At the time of the report, TREMOR (Shaking), TREMOR (Tremors), PYREXIA (Fever to 102 F), CHILLS (Chills) and PYREXIA (Low grade fever) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable. No treatment information was provided   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Emai Address updated
On the 27th I was feeling pretty darn tired. I went to my exercise class and couldn't make it through. I was on the sofa all day. In the middle of the night, I had severe body aches and could not sleep with headache. I had nasal congestion, drippy nose and a slight cough. I was in extreme fatigue. I took a COVID -19 Test it was negative. I decided I might have the flu, I went to urgent care the next day, the tested me again for COVID-19 test and, I was positive. They gave me Paxlovid. Before I decided to take it, I called my doctor for approval. I took it and by the next morning on my second dose I was feeling better, By Friday I almost felt normal. I had less congestion, cough and fatigue. I finished this morning and I have no symptoms at all except a little hoarse in my throat.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 25-SEP-2014, the patient was vaccinated inadvertently with GARDASIL dose 4, 0.5 ml, intramuscular. Lot number and expiration date were not reported. No adverse effects reported. Additional information has been requested.
New sensitivity to spicy foods with stomach acidity, moderate stomach pain, increased gas.  No response to self medicating with Pepcid Complete chewable tablet.
Patient failed, blood pressure dropped, paramedics were called.  Patient also got nauseous.
About 2 weeks after receiving the Moderna booster shot; I started experiencing a itchy rash/hives in several spots on my body. Began taken Zyertec once daily with relief until the medication wore off. I visited my PCP about 4 days after the rash/hives appeared and was prescribed Certirizine 10mg and Famotidine  20mg twice daily. Again, the symptoms showed relief but now real change in the recurrence of the rash the next day. PCP then prescribed 2 Prednisone 20mg daily with a taper after 7 days. After 4 days of taking the prednisone along with the Zertec and Famotidine, the rash/hives continue to flare up. Currently in the process of scheduling an allergist appointment.
I have been having since I got my second shot, back in March, body aches and joint aches/muscle pain. I thought I just needed to exercise more. I got the booster shot and 4-5 days later, I got chest pains - brief in duration - 2 to 3 minutes. They would go away and come back anytime during the day. It didn't wake me up at night. I went to the doctor on the 11th of November for all of these symptoms and she ordered lab work and I got that done on the same day. No treatment yet. I haven't had any in several days (chest pains).  I had the flu shot after this vaccine on the following Friday. I had that on the 5th of November. I had it had Pharmacy injection in right arm.
Patient is fully vaccinated and boosted.  Took a home COVID test on 5/8/2022 and it was positive.90-year-old female with history of atrial fibrillation currently anticoagulated on Coumadin, diabetes, CAD who presented complaining of difficulty in breathing that has been progressively worsening over a 2 to 3-day timeframe.  Patient states 3 days ago at nighttime she began to have "chills" and fatigue. + nausea, + cough. Pt hypoxic on admission with O2 sat 85% on RA. VSS. mild low sodium at 134.  Troponin negative x3.  CRP not significantly elevated.  Lactate dehydrogenase 267, fibrinogen 477.  No leukocytosis.  Procalcitonin 0.03.  D-dimer only 392.  Hemoglobin was 11.9. Chest x-ray was obtained and showed patchy right upper lobe airspace disease as well as some new right-sided rib fractures but otherwise no acute process. treatments: oxygen, decadron, coumadin, started on remdesivir but became badycardic. stable and discharged home.
Patient has had pain in her deltoid muscle since injection (4 weeks)- pain has not improved and is interfering with her activities.
Arm has been sore and just yesterday I noticed a rash and itching. I put cream (triamcilolone Acteonide) on it and took some benadryl and the itching has gone down.
Numbness, pins and needles it started in my arms , underarm back and now it's moved to my face, neck, both legs and inner thighs. And today it's Aug 25 and it?s getting worse .
Onset of fever and malaise within a couple of hours....102 temp. Anorexia abdominal pain. On 3/30/2018 I arrived home to find him paranoid delusional combative and making NO SENSE. I looked at his phone in which he had texted nonsense in 5 texts. I asked him to read them and he was unable. His gait was unsteady and he fell. He had difficulty with month and date knew year and president vice president. He did have a slight odor of alcohol BUT has never been like this after drinking 3 beers. I am aware that his 2 children were vaccine exempt due to severe reactions. He went to bed where he constantly flipped and flopped and writhed for several hours when I got out of the bed due to being repetitively kicked. He woke up and remembered NOTHING of what happened. Was shocked when I showed him the texts from his phone.
patient receiving IPOL and Quadracel on the same day; Initial information received on 29-Aug-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 5 years old patient who received vaccines DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] and IPV (VERO) [IPOL] and reported that patient receiving Ipol and Quadracel on the same day (extra dose administered).  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On 26-Aug-2019, the patient received 3rd dose of suspect 0.5 ml IPV (VERO) lot P1A242M and expiry date: 26-Apr-2019 via subcutaneous route in the right arm.  On 26-Aug-2019, the patient received a dose of suspect 0.5 ml DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE lot C5500CA and expiry date: 16-Aug-2020 via intramuscular route in the left arm.  It was a case of actual medication error due to extra dose administered.  It was unknown if the patient had any adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in 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.  List of documents held by sender: none.
w/in 3hrs exp numbness of lips-hoarseness flushing-temp inc-red eyes-red throat-went to ER @ hosp was given Epi & Pred inj & script for Pred decreasing dose pack &  DPH;next day eyes clear, throat ok, pounding, h/a, red face, hot flashes
Nausea and dizziness that lasted one hour after administration. Had student rest, drink water, and had parent pick up child from school.
This spontaneous case reported by a healthcare professional, describes the occurrence of dizziness, product dose omission issue (patient planned not to take second dose), fatigue and myalgia (muscle pain) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On May 27, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On an unknown date, patient experienced dizziness, product dose omission issue (patient planned not to take second dose), fatigue and myalgia (muscle pain). At the time of the report, dizziness, product dose omission issue (patient planned not to take second dose), fatigue and myalgia (muscle pain) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. The reporter did not provide any causality assessments, concomitant medication or treatment information.
Recieved 2nd moderna dose 02/04/2021 in my left arm at 10 a.m. approx.  No symptoms besides a small headache throughout day.  At 10:15 that evening I started to become chilled.  By 11 p.m. I had uncontrollable shaking chills, accompanied by a fever of 101 and body aches.  By 1 a.m. I was still having uncontrollable shaking chills and severe body aches and  Body sweats.  I had a sweatshirt on over a tee shirt and a heating pad on between the two with two comforters on. At 3 a.m. I had to take ibuprofen (800 mg) because my body hurt too bad to even touch my skin.  My eyelids hurt.  My toes hurt. My ears hurt.  My fever was up to 103.  I fell asleep finally and woke up at 730 a.m. feeling much improved besides some mild chills.  I made the wrong decision to go to work.  I arrived at work at 830 and by 10 a.m. I started to get chilled again, achy and feeling like I was going downhill again.  I decided to go home.  By the time I got home at 11 I had chills again, fever of 101 and body hurt.  I slept until 3 p.m. at which time I woke up chilled and wanted to take a hot shower.  My other half noticed I had hives on my face (which I documented in photos).  I took a benadryl and went back to sleep.  Woke up again at 7 p.m. tried to eat something but had no interest and just wanted to sleep.  Throughout the night I would get the sweats that would drench through my t shirt.  The following day, 2 days post 2nd dose I slept all day.  Not as chilled but very tired.  Noticed injection site was now red and swollen, again documented in pictures.  Slept all day.  Today injection site has gotten slightly larger based on markers I marked on my skin, but not as red.  Not too energetic but much improved.
fever,headache,chills,legs cramping,upset stomach, dizzy,loss of appetite, shortness of breath no energy tired all the time
This spontaneous report as received from a other health professional refers to a patient of unknown age. On an unknown date the patient was vaccinated with PROQUAD lot # M007963 for prophylaxis. On an unknown date the patient experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to PROQUAD. Additional information has been requested.