chrisvoncsefalvay/vaers-outcomes huggingface dataset:
a sore arm; a slight headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (a sore arm) and HEADACHE (a slight headache) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 030M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 14-Jan-2021, the patient experienced PAIN IN EXTREMITY (a sore arm) and HEADACHE (a slight headache). On 14-Jan-2021, PAIN IN EXTREMITY (a sore arm) had resolved. On 15-Jan-2021, HEADACHE (a slight headache) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 13-Apr-2021: Followup received on 13-Apr-2021. Contact details was updated(Email)
Made me feel sick. Injection site hived up, became red, swollen, itchy and sore. Muscle soreness whole arm, nausea, headache. Sick for about 4 days.
erythema at site (L) deltoid edema at site pain/tenderness all symptom in 9cm x 5 cm area on deltoid
Transient loss of consciousness while driving motor vehicle resulting in contact with another vehicle and injuries from airbag, specificly a broken arm.
Following vax pt put finger up nose & blew out clear mucous; then began to have difficulty breathing & began to swell around eyes; pt was examined by MD; given meds immed began to breathe easier; p/30 min d/c by MD;
This is a spontaneous report received from a contactable other HCP. A female patient received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), in left arm, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. Vaccination history included the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), for immunization. The patient experienced oral pain/sore mouth, onset Mar 25, 2021, with outcome of recovered. No therapeutic measures taken as a result of oral pain. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected. Sender's comments: Linked report(s): US-PFIZER INC-2021355634 same reporter/drug/AE, different patient.
ASYMPTOMATIC POSITIVE COVID-19 RESULT IN LIVER TRANSPLANT PRE-OP
Following the vaccine, I experienced a sore arm and minor bruising, but now several days later, I am experiencing a rash/swelling on my arm at the injection site. It is not necessarily itchy/painful, just inflamed and very red. It is roughly the size of a silver dollar, kinda ?dimpled?, and has irregular edges, like a histamine/allergic reaction to a poisonous plant might appear.
Pfizer COVID-19 Vaccine EUA  Patient presents 3/23/21 for medical monitoring of syncopal episode s/p COVID - 19 vaccine # 2.  Lowered to the floor by vaccine staff.  Patient reports symptoms of weakness, other wise states she ""feels fine"". Two additional syncopal episodes witnessed by myself when patient attempts to change position.  Past medical history is significant for mild persistent allergic asthma, pre-diabetes, OSA, obesity and BPPV.  Patient reports history of same reaction s/p previous vaccine.  At a approximately 0837 patient was noted to have a worsening rash present to her face.  EpiPen administered via left lateral thigh at 0838.  EMS called to transport patient the ED for further evaluation.    Treatment administered: epipen (lot 0FM406, exp 02/22) left lateral thigh at 0838.    Upon arrival to the ED, patient's temperature is 98.8° F, heart rate 92-103, respiratory rate 30, saturating 99% on room air with blood pressure 164/91.  The patient's laboratory studies were largely unremarkable.  While in the ED, the nurse was getting ready to get the patient up to the commode when the patient started to ""not feel right again.""  She asked her to administer the medications for allergic reaction and reports wall the 2nd medication was being infused, she felt paralyzed and unable to talk, although she was able to hear everything and was aware, she was unable to move or speak for a short amount of time.  CT head with completed at this time and showed no acute intracranial findings.  Chest x-ray unremarkable.  EKG showed normal sinus rhythm with sinus arrhythmia, heart rate 80 and prolonged QT at 470.  The patient was administered Solu-Medrol 125 mg IV, Pepcid 20 mg IV, Benadryl 50 mg IV, normal saline 1 L IV.  Pt was admitted to hospital for observation.    The patient was seen on the unit laying in bed with her husband at the bedside.  She reports that she is feeling slightly better and hungry and has never felt at paralyzed/unable to speak feeling before and is very nervous about this.  She was wondering if she had a seizure, although she reports feeling aware the entire time and did not lose bowel or bladder function. We discussed that that is not typical for a seizure, but even if we did an EEG at this time, it would not be able to tell us what occurred in the past.  We discussed continue the Benadryl, Pepcid, and IV steroids for today and likely decreasing them tomorrow. We discussed the workup of syncopal episodes as well. The patient and her husband were agreeable to this plan.    Patient was discharged from the hospital on 03/24/2021 in a stable medical condition.  Patient was instructed to follow-up with her PCP in 1 week.
fever of 99; sore arm at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore arm at injection site) and PYREXIA (fever of 99) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. UNK) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Sep-2021, the patient experienced PYREXIA (fever of 99). In September 2021, the patient experienced VACCINATION SITE PAIN (sore arm at injection site). At the time of the report, VACCINATION SITE PAIN (sore arm at injection site) and PYREXIA (fever of 99) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Sep-2021, Body temperature: 99 (High) fever of 99.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product information was not provided.  Treatment information was not provided.
Strong throat irritation and wheezing began 5 minutes after administration. Breathing not severely impacted.  Pulse and oxygen saturation remained normal.  Throat irritation continued for the rest of the day, wheezing subsided quickly.
Weakness, nausea, vomiting 3 hours later.  Next 2 days anoxemia, nausea, chills.  Day #3 at store and passed out.  ER evaluation negative.  Took one month to get full strength back.
A patient had been administered doses of the Moderna covid-19 vaccine on 8 APR 2021,9 DEC 2021; This spontaneous case was reported by a health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (A patient had been administered doses of the Moderna covid-19 vaccine on 8 APR 2021,9 DEC 2021) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 067F21A and 007B21A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.   On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Dec-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Dec-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (A patient had been administered doses of the Moderna covid-19 vaccine on 8 APR 2021,9 DEC 2021). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (A patient had been administered doses of the Moderna covid-19 vaccine on 8 APR 2021,9 DEC 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were mentioned.  No treatment details were reported.  Patient did not reported any symptoms.   This case was linked to MOD-2022-538598 (Patient Link).
I had a little bit of a headache and my right arm where the injection is - was kind of hurting a little bit (which is a normal reaction to the vaccine). Also, I had a little bit of fatigue. Those symptoms lasted a day or two. Those symptoms did come back - came and went - but they are not doing that anymore.  I just let it pass  - as far as letting symptoms run it's course- no treatment.
Information has been received from a healthcare worker referring to unspecified patients of unknown age and gender. On unknown dates the patients were vaccinated with oral, ROTATEQ (batch#/lot# L000425, expiration date and dose were unknown) which were exposed to temperatures outside of the recommended range. No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Foot pain; stomach pain; started losing muscle mass; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Foot pain), ABDOMINAL PAIN UPPER (stomach pain) and SARCOPENIA (started losing muscle mass) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced SARCOPENIA (started losing muscle mass). On 28-Mar-2021, the patient experienced PAIN IN EXTREMITY (Foot pain) and ABDOMINAL PAIN UPPER (stomach pain). At the time of the report, PAIN IN EXTREMITY (Foot pain), ABDOMINAL PAIN UPPER (stomach pain) and SARCOPENIA (started losing muscle mass) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication was unknown
Background: I received Pfizer Covid vaccine # 1 on 12/20/20, only sore arm. Pfizer #2 on 1/10/21, the next day had about 12-24 hours of chills, body aches, malaise. I felt fine the next day.  For my booster, listed above, given because I work as a nurse in a hospital, I had the following Prolonged symptoms: 9/14 and 9/15- fatigue, body aches, chills, I worked half days both days. 9/17 I worked 8 hours. 9/18, worked half day due to fatigue. 9/20-worked 3/4ths of my shift, left work early due to fatigue and body aches,  9/21 and 9/22-worst days of fatigue, body aches, headache; these are days 8 and 9 post vaccine. Had urgent care tele-visit, labs done, mostly WNL Finally on 9/23 I felt close to normal.    I want to report this because the length of time of my symptoms seems very unusual. I was in very health prior, walking 2 miles per day.
"I" had a fever of 101 the following day with the chills. It lasted about 24 hours.; "I" had a fever of 101 the following day with the chills. It lasted about 24 hours.; This is a spontaneous report from a non-contactable consumer, the patient. A 49-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 15Apr2021 at 18:00 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. The medical history included penicillin allergy. 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 COVID-19 vaccine. The patient did not receive any medications within two weeks of vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. On 16Apr2021 at 09:00,the following day the patient experienced fever of 101 and chills. The patient reported that it lasted for about 24 hours. On 16Apr2021, the patient underwent body temperature test and the result was found to be 101(unspecified unit). The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of events fever of 101 and chills was recovered on an unknown date in Apr2021.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Patient Stated that he felt a cold fluid running down his arm as he was receiving the second dose. He looked and saw a clear fluid running down his arm. The patient got home and felt like he did not receive a full 2nd dose of the vaccine and returned the next day asking to receive a repeat dose. Per CDC guidelines since amount administered was not known, a full repeat dose was given one day later (on 3/4/21).
Client was waiting in observation 30 mins when she asked EMTs  to check her blood pressure as she was feeling palpitations. First vitals at 1512: blood pressure 158/100, pulse 82, oxygen 98%. PHNs arrived shortly. Client sitting in chair, alert and oriented x4. Per client had reaction to Pfizer first dose and medical team had recommended Janssen as second dose instead. Per client feeling nausea, headache, and palpitations. PHN gave client emesis bag. Client assessed for swelling, flushing, per client no shortness of breath at this time. Retake of blood pressure at 1513: 150/100. Per client history of hypertension, diabetes, thyroid, and took her medications today. No other allergies except Pfizer vaccine. 1515 client reported feeling warmth sensation to throat area and feeling itchiness. Per client it was same reaction to Pfizer vaccine. PHN asked client if she drove, per client had family outside waiting. PHN offered client Benadryl and client accepted. PHN administered 50mg IM on right deltoid at 1519. Vitals: pulse 107, oxygen 98%. At 1522 client stated stronger itchy throat and felt like it was starting to close. No swelling noted, per client feeling tingling around lips. Client stated shortness of breath, unable to take deep breaths. PHN Ae called 911. 1524 pulse 104, oxygen 99%. Per client feeling very dry mouth. PHN kept speaking with client, alert and oriented x4, able to answer all questions in short answers. 1527 pulse 103, oxygen 99%. Client stated feeling warmth in throat area again, began coughing intermittently. Per client new onset of strong headache to occipital area, dizziness and chills. 1531 paramedics arrived and assumed care. Client transported to facility via gurney at 1540.
#1 9-20-07. #2 5-27-11. Has had 2 varicella vac - diagnosed varicella.
Pt here for 2nd dose of Pfizer vaccine. Nursing student to administer vaccine to Pt. During injection, nursing student reports an "undefinable" amount of vaccine leaked from patient arm and out of syringe. Recommendation was to administer additional dose of vaccine in other arm. Vaccine administered by RN.
Pt states her (L) arm has been sore ever since she had the BOOSTRIX. She has shooting pain with certain movements, for weeks she couldn't raise her (L) arm. Took ALEVE and used (L) arm as much as she could to try to relieve the pain.
This case was reported by a consumer via call center representative and described the occurrence of pain in a male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pain in extremity (for tolerance of 1st dose refer case US2019049135). On 11th March 2019, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 12th March 2019, 1 days after receiving SHINGRIX, the patient experienced pain, chills, fever, fatigue, erythema of extremities, swelling arm and skin warm. On an unknown date, the outcome of the pain, chills, fever, fatigue, erythema of extremities, swelling arm and skin warm were recovered/resolved. It was unknown if the reporter considered the pain, chills, fever, fatigue, erythema of extremities, swelling arm and skin warm to be related to SHINGRIX. Additional details were provided as follows: The case was reported by patient's wife. The age at vaccination was not reported. The patient received SHINGRIX on right arm. The patient experienced aches, chills, fever, and fatigue. The patient's right arm was swollen, red and hot to the touch. It was reported that the patient had scheduled blood work after receiving the 2nd dose of SHINGRIX and the patient's absolute lymphocyte count was low. The reporter was not sure if it was caused by the vaccine and also reported that she would call the doctor regarding the lab result.
The patient did not have an adverse event. The nurse who administered the vaccine gave approximately 4 doses instead one of 0.5mL dose.
Patient was observed to cry out and fall backward; then extremities became stiff and patient cried out again.  Pupils were observed to dilate and then constrict significantly.  Episode lasted about 1 minute after which patient fell asleep.  When patient awaoke, she was quieter than usual.
Information has been received from a medical assistant referring to an unspecified number of patients off unknown age and gender. There was no medical history or drug reaction reported. Doses of improperly stored (Oka-Merck) PROQUAD (lot # L010142 with expired date 24-SEP-2016, lot# L005293 with expired date 17-AUG-2016, dose and route were unknown) were vaccinated to the patients on 29-JUN-2015, 06-JUL-2015, 04-AUG-2015, 06-AUG-2015, 11-AUG-2015 and 14-AUG-2015. No concomitant medication was provided. No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
Patient presented to emergency department at Hospital on 2/03/21 with chief complaint of numbness and tingling over entire left side of body with pain level 9 out of 10. Patient reported that she received first dose of COVID vaccine on 1/25/21. On 1/31/21 numbness began in left lower extremity and progressed to left upper extremity over course of several days. Patient was afebrile, alert and ortiented. Circulation, range of motion and sensation intact. Lumbar puncture performed and appeared normal. Fentanyl 50mg IVP, Zofran 4mg IVP administerd and symptoms improved. Patient discharged home per doctor. Prescription provided for gabapentin 300mg 3 times daily. Follow up with PCP in 2-3 days recommended
RASH TO ARMS,CHEST 7 NECK;  GIVEN 50 MGM BENADRYL PO
Shortness of breath, asthma symptoms, coughing, heart racing, sweating, muscle aches, fever. Initially, as the days went on the asthma and coughing became worse, the other muscular symptoms, fever, pain decreased. But the asthma became worse. I was seen and evaluated at Urgent Care they heard wheezing and gave me Albuteral inhaler. By Wednesday my symptoms were worse my doctor prescribed a Medrol Doze Pak. Symptoms seemed to be resolving but I continue to have intermittent episodes of racing heart, 118 beats to 126 beats. I literally feel like there is a humming bird in my chest. I finished the steriods yesterday and today I feel like the asthma is stalled and I may need a longer term inhaler. I have a doctors appointment later today.
Pt vaxed w/Hep B (recomb) one half the usual dosage on 30OCT90 & 31OCT90; 27NOV90 pt recd 2nd dose of vax 1ml; @ time of the report there was no adverse rxn;
Syringe malfunction causing patient to not receive full dose. Full dose was given in opposite arm. No side effects/adverse reactions were observed.
I FELL TWICE AFTER 1ST VACCINE DOSE HAD HEADACHES AND I WENT TO THE DOCTOR WHO SENT ME FOR A CAT SCAN WHICH DIAGNOSED A CONCUSSION.
DIZZINESS, SYNCOPE FOR A FEW SECONDS, THEN REGAINED CONSCIOUNESS. PARAMEDICS CAME, SX RESOLVED, NO TRANSPORT.
8mins post vaccination pt reported nausea and dizziness.  Vitals: 109/66, 53, 20 Pt stable and released from the vaccination site @15:10.
office administered an expired highdose flu vaccine from 2021-2022 season (with no reported adverse event); Initial information received on 15-Nov-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves Adult and unknown gender patient who reported office administered an expired INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] from 2021-2022 season (with no reported adverse event).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On an unknown date, the patient received a  dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE Suspension for injection in pre-filled syringe (lot UJ690AB) via intramuscular route in unknown administration site for Prophylactic vaccination .  On an unknown date the patient reported  a non-serious event office administered an expired INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] from 2021-2022 season (with no reported adverse event) (expired product administered) (unknown latency).  Action taken: not applicable.   At time of reporting, the outcome was Unknown for the 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 the 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.
Excruciating back pain and headache, fever, diarrhea, chills. Dont know how to treat.
Five days of diarrhea Odd consistency - neither watery nor solid but more just like a pile of mud Smelled sour Resolved
TIREDNESS; FEVER 99.2 - 100.9; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included covid 19. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On APR-2021, treatment medications included: paracetamol. On 10-APR-2021, the subject experienced fever 99.2 - 100.9. Laboratory data included: Body temperature (NR: not provided) 99.2 . On 12-APR-2021, the subject experienced tiredness. Laboratory data included: Body temperature (NR: not provided) 100.9 . The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever 99.2 - 100.9, and tiredness. This report was non-serious.
Myalgia, Arthralgia, Fever, fatigue Narrative: Initially, left arm hurt. by PM muscles felt very sore. low grade fever, excessive fatigue. 07/16/22 geadacgem neck pain, sore thorat
Pericarditis 3 weeks post vaccine.  Sharp pleuritic chest pain which started on 9/18 - worse with inspiration.  Seen in ED, other causes of chest pain ruled out.