chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I had swollen  armpit lymph node on the left arm 6 days later after the first dose of the Pfizer vaccine.
nausea; FEVER; headache; aches for five days.; This case was reported by a consumer via call center representative and described the occurrence of nausea in a 56-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 4th November 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 6 months after receiving Shingrix, the patient experienced nausea, fever, headache and general body pain. On an unknown date, the outcome of the nausea, fever, headache and general body pain were recovered/resolved.   It was unknown if the reporter considered the nausea, fever, headache and general body pain to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received the first Shingrix shot on November 4th and had until May 4th to receive the booster.  However, given the pandemic Ipatient was wondering if I should proceed with it.  The patient had received conflicting advice from my physician and their pharmacist.  The patient did have a fairly strong reaction to it the first round, i.e., fever, nausea, headache, aches for five days.
Patient received COVID vaccine which was considered expired as it exceeded the recommended expiration. The medication was kept at appropriate temp and minimal room temp exposure. There were no obvious side effects as a result of this.
nausea,  headache, myalgia started the evening of administration, she received second dose 5/11/23, had worsening headache, myalgias, nausea, also developed urticaria about 4 hours after second dose administration
Swelling of tricep area of right arm. Symptoms-itching Treatment: BENADRYL, KEFLEX
This spontaneous report has been received from a nurse practitioner referring to a 56 year old female patient with allergy to penicillin as concurrent condition. The patient had no medical history, or concomitant medications to be reported. On 15-NOV-2018,the patient was vaccinated with PNEUMOVAX 23, intramuscular in the left deltoid (strength, dose, frequency, lot# and expiration date were not provided) to prevent pneumonia. It was reported that on the same date (15-NOV-2018) (reported as one hour after the administration of PNEUMOVAX 23, the patient experienced erythema (injection site erythema), tenderness and pain below the injection site (injection site pain) and arm stiffness (musculoskeletal stiffness). The reporter stated that the patient self medicated with BENADRYL, BENGAY (contradicting information as it was also reported that the patient did not received any treatment). Furthermore, the patient visited the doctor's office on 16-NOV-2018. No laboratory studies were performed. The outcome of injection site erythema, musculoskeletal stiffness and injection site pain was reported as not recovered, as it was reported that the patient did not feel relief. At the reporting time, the causality between the aforementioned events and therapy with PNEUMOVAX 23 was not reported.
Information has been received from a 25 year old female with a penicillin allergy with a history of appendicitis (age five) and shingles (2005) who on 24-MAY-2007 was vaccinated with a first dose of Gardasil. Concomitant therapy included LO/OVRAL. On 25-MAY2007 the patient experienced shortness of breath and was hospitalized. The patient spent four days in the intensive care unit out of the nine days she was hospitalized. On 29-MAY-2007 the patient was diagnosed with a pulmonary embolism and was placed on COUMADIN. It was reported that the patient also developed heart failure "because of the pulmonary embolism". Laboratory data revealed all proteins low. The genetic tests yielded positive results for 2 genetic traits (specific names of the traits are unknown). At the time of report the patient was recovering. No further information is available. 8/15/07-records received DC Summary for DOS 7/23-7/24/07- DC DX: Chest pain not otherwise specified. Palpitations. Hypercoagulable state. Recent pulmonary embolus.VQ Scan low probability for pulmonary embolus. Pain was similar to previous event. Massive pulmonary embolus requiring use of TPA about two months prior. Now on chronic coumadin therapy. DC Summary for DOS 5/29-6/9/07-DC DX Pulmonary embolism with shock, hypotension, syncope and history of oral contraceptive use.
Received the COVID 19 Pfizer booster at 24 weeks and 1 day pregnant. Received the first two doses prior to conception and did not have any reaction following. The day following the Covid booster (10/7/21) I began to notice a rash on my stomach and back. The rash continued to spread on 10/8/21 and 10/9/21 until spread stopped around 10/10/21. The rash remained mostly on my trunk (stomach, back, and breasts). The rash closely resembled pityriasis rosea. It was hive like  in nature and went up my sides were it appeared to be the worst. The rash was not very itchy and did not respond to Benadryl.  The rash slowly started to subside beginning 10/16/21 however is still present. I saw the OBGYN on 10/14/21 to ensure baby was ok and not seriously impacted by this immune response. At this time, the baby seems to have not been impacted. Dermatology referrals was put in, but they have not had the capacity to fit me in.
Approximately 30 minutes following HBV injection patient became very weak, diaphoretic, pale and dizzy. Symptoms continued approximately 45 minutes when he was transported to home by wife. To ER on 1/28/07 due to continuing symptoms.
This spontaneous report as received from a medical assistant (at another office) via other health professional (registered nurse) refers to a patient of unknown age and demographics. Current conditions and medical history was not reported. On 07-OCT-2014, the patient was vaccinated with RECOMBIVAX HB 10 microgram per milliliter. Concomitant medications were  not reported. On 07-OCT-2014, the patient received an expired dose of RECOMBIVAX HB (lot number H014029 and expiry date 07-SEP-2014). No symptoms reported. Product quality complaint was not reported. Additional information has been requested.
High blood pressure, headache, arthritic pain in neck, hands, knees and ankles for 10 days.  No fever, no liquid retention.
Information has been received from a registered nurse concerning an adult female (age unknown), with no reported medical history or drug reactions/allergies, who in December 2005, was vaccinated (ROUTE UNKNOWN) with a dose of pneumococcal 23v polysaccharide vaccine (Lot# not reported).  The nurse reported that a recent titer did not show seroconversion.  No product quality complaint was involved.  Additional information has been requested.
Two hours after vaccination started to get a rash at injection site, continued to get bigger as time went on and got painfully itchy; The rash was warm, hard and lumpy; Started using an ice pack on area that night and it helped; Went and got Cortisone the next day and it seemed it help; Work in healthcare and had to go back to work the next day; Scrubs irritated the rash and it became bigger and more painful.
A patient received ACT-HIB VACCINE which was not mixed with the diluent, no AE; Initial information regarding an unsolicited valid non-serious case was received from pharmacist via Global Medical Information (Reference number- 00674736) and transmitted to Sanofi on 08-Jul-2021.  This case involves a patient (unknown demographics) who received HIB (PRP/T) VACCINE [ACT-HIB] which was not mixed with the diluent (product preparation issue).  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect HIB (PRP/T) VACCINE (lot number and expiry date not reported) via an unknown route in an unknown administration site for prophylactic vaccination which was not mixed with the diluent (product preparation issue).  It was reported that "The caller wanted to know what to do from here. Pharmacist reported ActHIB was administered with diluent other than what was provided with vaccine''.  It was a case of actual medication error due to Inappropriate reconstitution technique (latency same day).  At time of reporting, no adverse events were 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 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.  There will be no information available on the batch number for this case.
I have had a migraine for the past week since I received the vaccine.; I have had a migraine for the past week since I received the vaccine.; This is a spontaneous report from a contactable consumer (Pharmacist). This Pharmacist reported for herself.  A 23-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Lot Number: EW0183), dose 2 via an unspecified route of administration, administered in right arm on 16Jun2021 at 13:30 (at the age of 23-years-old) as dose 2, single for COVID-19 immunization. Medical history included migraine. Historical vaccine included 1st of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0187) as 1st single dose, administered in right arm, on 25May2021 at 02.30AM. Facility where the most recent COVID-19 vaccine was administered at hospital. Patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient had not been tested for COVID-19 nor before neither since the vaccination. Concomitant medications received within 2 weeks of vaccination include ibuprofen (ADVIL MIGRAINE), sumatriptan (SUMATRIPTAN) and omeprazole (OMEPRAZOLE). The patient experienced migraine for the past week since patient received the vaccine on 16Jun2021 at 08:00. On the second day, patient took 800mg of ibuprofen and 1000 mg of Tylenol ES and it did nothing to my migraine. Patient have had to take several sumatriptans since then and it only "dulls" patient migraines but it does not go away. Patient had been trying higher doses of ibuprofen (not exceeding total daily dose) and sumatriptan together, which had managed to allow patient to get through the day, but migraines had not went away. The outcome of the event was not recovered.   Additional Information has been requested.; Sender's Comments: As there is temporal relationship in the case provided, the causal association between the event and the suspect drug cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
sore arm-h/a, temp (fever);aches (body)-glassy eyes, runny, then stuff from nose;some cough, sore throat, 6 days sick;
flu-like symptoms; body aches/muscle pain; sharp pain in pelvic area; This spontaneous case was reported by a consumer and describes the occurrence of PELVIC PAIN (sharp pain in pelvic area), INFLUENZA LIKE ILLNESS (flu-like symptoms) and MYALGIA (body aches/muscle pain) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced PELVIC PAIN (sharp pain in pelvic area). On 05-Mar-2021, the patient experienced MYALGIA (body aches/muscle pain). On 06-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu-like symptoms). At the time of the report, PELVIC PAIN (sharp pain in pelvic area), INFLUENZA LIKE ILLNESS (flu-like symptoms) and MYALGIA (body aches/muscle pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant information was reported. No treatment information was reported.
This spontaneous report has been received from a female patient of unknown age, who was reporting on herself. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date in 2014, the patient was vaccinated with PNEUMOVAX 23 subcutaneously, lot # J006082, expiration date 12-APR-2014 (dose was not reported). On an unknown date, the patient experienced "a severe allergic reaction" and injection site arm swelled and became bright red. The patient visited a physician office the next day, but no treatment was given. There were no lab diagnostic studies performed. No product quality complaint has been filled. The outcome of the events was reported as recovered/resolved (reported as swelling and redness went away in about 2 or 3 days). The relatedness between the events and PNEUMOVAX 23 was not reported.
pt received vaccine at approximately 0730 in am. Waited his 15 minutes. He feels since he received the vaccine his heart is racing, and feels like his throat is tightening. He denies wheezing, has no angioedema. No exacerbating or alleviating factors, symptoms constant. Denies fever, chills, chest pain, shortness of breath or palpitations. Former smoker. No rash present. Pulse Ox is normal 96-99. One blood pressure reading was elevated, temp normal.   Treated with solumedrol, pepcid, benedryl, iv fluids. Observed for one hour, discharged home with steroids and antihistamine. Advised not to take 2nd covid vaccine by ER provider.
Shot was on evening of 7/22/19. Day of 7/23/19, fever up to 103.0 (using forehead thermometer), extreme tiredness, moderate aches/pains in most joints, sharp pain in elbow joint below injection site, strong injection site pain to point of difficulty using affected limb for anything mildly strenuous, brushing teeth was difficult with that arm, slight headache. Symptoms mostly resolved next morning, no medical attention sought
Pulmonary embolism and infarction, Xarelto. Unknown how long to be on meds
07/15/2022 She had reports of diarrhea at daycare. That night she continued having diarrhea. Saturday morning, she had fever. The highest her fever got was 101.4. The diarrhea continued through 7/19/2022. The diarrhea had mucous and three of her movements contained blood.  She was tired and irritable.   She has not had no diarrhea today.  She is doing pretty well now.
Serious itching on the skin on lower legs after first dose; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Serious itching on the skin on lower legs after first dose) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Jun-2021, the patient experienced PRURITUS (Serious itching on the skin on lower legs after first dose). On 10-Jun-2021, PRURITUS (Serious itching on the skin on lower legs after first dose) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medication information was provided. No treatment medication information was provided.   This case was linked to MOD-2022-512309, MOD-2022-512313 (Patient Link).
very very tired with no energy; like flu; headache; severe muscle aches; chills; Fever; L arm sore for a couple of days; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (like flu), PAIN IN EXTREMITY (L arm sore for a couple of days), HEADACHE (headache), MYALGIA (severe muscle aches) and CHILLS (chills) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 032M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included MULTIVITAMIN & MINERAL for an unknown indication.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced PAIN IN EXTREMITY (L arm sore for a couple of days). On 07-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (like flu), HEADACHE (headache), MYALGIA (severe muscle aches), CHILLS (chills) and PYREXIA (Fever). On 15-Apr-2021, the patient experienced FATIGUE (very very tired with no energy). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, INFLUENZA LIKE ILLNESS (like flu), PAIN IN EXTREMITY (L arm sore for a couple of days), HEADACHE (headache), MYALGIA (severe muscle aches), CHILLS (chills), PYREXIA (Fever) and FATIGUE (very very tired with no energy) outcome was unknown.            Treatment medication include Zincodin  to sleep.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable   This case was linked to US-MODERNATX, INC.-MOD-2021-078266 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-078266:cross linked to Dose 1
rapid onset of intense Dizziness followed by Nausea lasting approximately 2 hours also had fatigue and had to sleep for several hours.
Injection site skin marks; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Injection site skin marks) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis, Hypertension and Alcohol use. Concomitant products included LOSARTAN and HYDRALAZINE for Blood pressure high.   In December 2020, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 mg. On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced VACCINATION SITE REACTION (Injection site skin marks). At the time of the report, VACCINATION SITE REACTION (Injection site skin marks) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       On 19 Feb 2021, patient received, second dose of mRNA1273. Treatment information was not provided.
Teeth ached starting 40 hours after vaccination. Rates pain 6 of 10. Not aching at this moment. Lasted throughout the night. Did not take any pain relief medications. C/O some tightness in chest which is regular for him. Encouraged to see MD and he stated he has had this before and was not concerned.
Sx onset: 7/12/21 cough, runny nose, sore throat, fever, headache, loss of smell & loss of taste. Tested on 7/15 for COVID-19 which was positive.
rash w/small spots over all body w/high temp six days later still had rash;rash has persisted for 6 days;
Mark on leg; flat, round, half an inch in size and like strawberry color; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Mark on leg) and ERYTHEMA (flat, round, half an inch in size and like strawberry color) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, the patient experienced RASH (Mark on leg) and ERYTHEMA (flat, round, half an inch in size and like strawberry color). At the time of the report, RASH (Mark on leg) and ERYTHEMA (flat, round, half an inch in size and like strawberry color) outcome was unknown. Not Provided          The patient is on concomitant medications. No treatment information was provided.  The action taken with  mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-106672 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-106672:HUSBAND CASE
72 hours of arm soreness and  joint pain around shoulder of arm and neck soreness where the vaccine was injected.  About 24 hours of fatigue, muscle soreness & chills that began 12 post injection.  About 12 hours of fever and sweats that began 12 hours post injection.  Moderate symptom relief from acetaminophen and ibuprofen.
04/23/2022 Around noon I cut the grass and then I got itchy eyes and an itchy throat. I took Claritin and it went away.  I tested positive for COVID-19 on 4/25/2022 was positive.
Pt to ED 7/28 cc of SOB, +COVID by home test and upon admission 7/28. Pt has SOB upon exertion, patient oxygen saturation level at 91 percent on 4L NC, HOB elevated, warm blankets applied. 7/29 Pt  maintained on Decadron 6 mg, to start remdesivir. 7/31 Pt is AOx4, remains on 5L 02 NC not in distress, denies pain or discomfort. 7/31 Patient is A&Ox4 and continues to request to leave AMA. Pt discharged home with 4L of oxygen with all personal belongings VSS.
p/vax pt devel redness & induration @ the inj site which extended to the elbow;dx of allerg rxn;cellulitis was made & pt was treated w/DPH & Levaquin;pt recovered;
Blood in urine; Headaches; Muscle pain; Joint pain; Fatigue; not plan to take second dose; kidney problems; This spontaneous case was reported by a consumer and describes the occurrence of RENAL DISORDER (kidney problems), BLOOD URINE PRESENT (Blood in urine), HEADACHE (Headaches), MYALGIA (Muscle pain) and ARTHRALGIA (Joint pain) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (cipro), Food allergy (gluten), Chronic kidney disease stage 3 since 01-Jan-2000 and Thyroid cancer. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroid cancer, FISH OIL, VITAMIN E [VITAMIN E NOS] and VITAMIN D [VITAMIN D NOS] for an unknown indication.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced RENAL DISORDER (kidney problems). On an unknown date, the patient experienced BLOOD URINE PRESENT (Blood in urine), HEADACHE (Headaches), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain), FATIGUE (Fatigue) and PRODUCT DOSE OMISSION ISSUE (not plan to take second dose). At the time of the report, RENAL DISORDER (kidney problems) had not resolved, BLOOD URINE PRESENT (Blood in urine), HEADACHE (Headaches), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain) and FATIGUE (Fatigue) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (not plan to take second dose) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood urine: Urine was tea color 10 days after the vaccination date.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided. Action taken with mRNA-1273 in response to the event was unknown   Most recent FOLLOW-UP information incorporated above includes: On 22-May-2021: Patient demographics, and concomitant medications updated.