chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Suspected pneumonia (bad cough), high fever, sore throat, ear pain, swollen, painful glands, nausea, fatigue, headache, clear, textured rash.(The rash began about a week after the vaccine.) Currently on day 7 of flu-like symptoms. Started Azithromicin yesterday. Still sick.
fever; body aches; urinate a lot; This is a spontaneous report received from a contactable consumer (patient) via a Pfizer Sponsored Program. A male patient of unspecified age started to receive first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection) via an unspecified route of administration on 21Apr2021 as SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unknown date, the patient experienced fever, body aches and urinate a lot after taking the first dose yesterday. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Severe rash and welts on right side of body between breast and knee. Did not erupt similar to shingles, more like chicken pox, but only on right side of body. 3 welts on right arm, about 12-20 on right thiegh, but most is on my tummy area. Was treated with Valtrex 3 times per day, and a Methyiprednisolone pack, and by Monday morning was calmed down a bit.  No pain whatsoever but very severe itching.
Resting heart rate of 130+ - beginning early Monday morning, continuing throughout the day on Monday. Resting heart rate still above 90 on 4/29 severe headache - 3-4 hours after waking, subsided later in the day pain, redness, hardness at injection site - still ongoing
Information has been received from a health professional concerning a patient (32 out of 40) who was vaccinated with Pneumovax 23 (lot number 651406/0620F).  It is unknown if the patient was vaccinated with the influenza virus vaccine (unspecified) on the same day.  Subsequently the patient experienced fever, pain at injection site, redness at injection site, swelling at injection site and red streaks on injection arm.  Subsequently, the patient recovered from fever, pain at injection site, redness at injection site, swelling at injection site and red streaks on injection arm.  The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory.  The lot complies with the standards of the agency and was released.  Additional information has been requested.
Information has been received from a physician via a company representative referring to unspecified patients of unknown age and gender. Information about patients' medical history, concurrent conditions and concomitant medication were not reported. On an unknown date, It was informed that multiple unspecified people reported to the physician about reading "somewhere" (unspecified) about premature ovarian failure occurring with GARDASIL 9 (lot #, expiration date, dose and route were not reported) for prophylaxis. It was unknown if there were patients involved. The outcome of the event and the causality were not reported. As on 28-NOV-2016, all telephone attempts to obtain follow up information have been unsuccessful. Additional information has been requested. Sender's Comments: MERCK 1609USA013051: Mfr number.
This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. Information on his/her pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On an unknown date, the patient was inadvertently vaccinated with an improperly stored dose of GARDASIL 9 injection (dose and route of administration were not reported) (lot # N035955, expiry date: 09-OCT-2020) for prophylaxis. The vaccine was exposed to temperature of 9 degrees Celsius (C) to 25 C for 65 hours 15 minutes. There was no previous temperature excursion. No adverse effect was reported. The digital data logger was involved in recording the temperature excursion. There was no product quality complaint (PQC) reported.
Swollen lump on collarbone appeared 2 days after and is still currently there causing right arm and chest pain
VACCINE TEMPERATURE EXCRUSION FROM 3.1 C TO 0.77 C TO 3.0 C WITHIN 30 MINUTES; OUT OF SPECIFICATION PRODUCT USE; This spontaneous report received from a health care professional concerned a 40 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 26-AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 26-AUG-2021, the patient experienced vaccine temperature excrusion from 3.1 c to 0.77 c to 3.0 c within 30 minutes, and out of specification product use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine temperature excrusion from 3.1 c to 0.77 c to 3.0 c within 30 minutes and out of specification product use was not reported. This report was non-serious. This case, from the same reporter is linked to 20210855173.
night sweats/ sleeps in t shirts and shots and the t shirt is all sweat; felt with no energy; flu symptoms; tired; This spontaneous case was reported by a consumer and describes the occurrence of NIGHT SWEATS (night sweats/ sleeps in t shirts and shots and the t shirt is all sweat), ASTHENIA (felt with no energy), INFLUENZA (flu symptoms) and FATIGUE (tired) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced FATIGUE (tired). On an unknown date, the patient experienced NIGHT SWEATS (night sweats/sleeps in t shirts and shots and the t shirt is all sweat), ASTHENIA (felt with no energy) and INFLUENZA (flu symptoms). At the time of the report, NIGHT SWEATS (night sweats/sleeps in t shirts and shots and the t shirt is all sweat), ASTHENIA (felt with no energy), INFLUENZA (flu symptoms) and FATIGUE (tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient said that it felt fine but since it had the shot for the last 7 days was getting night sweats, it was not that the room was excessively hot and was felt fine. The patient mentioned that on the second day (Friday February 5th) itself and the spouse felt really tired. It lasted until Saturday February 6th and they felt with no energy but that didn't stopped them nor anything, and stated that was almost as flu symptoms.  Treatment information was not provided.
Vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine given 6 days post expiry) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.   This case was linked to  (Patient Link).
Raised spots - back abd, 12/26/09 started ZOVIRAX 200 mg 3 PO BID X 5 days.
Cold sore for 1 week  Exhaustion still ongoing Exacerbated Fibro symptoms
During post observation time, patient started going down on the floor. Pt was still responsive. Pt mentioned that has history of low blood sugar sometimes. patient  was given sugar pill and EMS was called. Blood sugar went up (measured by EMS) after chewing sugar pill and patient was normal.
Feeling of pinches nerve in left elbow. Tingling in left fingers. Tightness on left side of chest. Weak feeling in left arm.
Patient received flu vaccine at clinic (brand unknown) diaphoretic, fever (101), chilled, light headed upon a few minutes of receiving flu shot at clinic. Given tyelonol, albuterol, benadryl at clinic. Presented to ED. Received IM epinephrine, solumedrol. Patient doing better.
5 MINUTES AFTER THE VACCINE, PATIENT REPORTED FEELING UNWELL. PATIENT TOLD HAVING TINGLING IN THE MOUTH AND TONGUE BUT BREATHING NORMAL; FLUSHING AND HOT ALL OVER THE BODY. FEEL DIZZY.
Symptoms began  with nausea,  vomiting and diarrhea during the night of  vaccination, next morning and during that day I had joint pain, headache, nausea, vomiting, fever,  and chills.  My lymph nodes in the same arm of the injection are swollen and tender to the touch and continue to be today (5 days after injection).
Information has been received from a health professional concerning a 16 year old female patient with a history of absence seizure free for 2 years-off divalproex sodium (DEPAKOTE for 2 years) who on 25-JUN-2008 at 10:00 am was vaccinated intramuscularly in the right arm with a first dose of GARDASIL (Lot #658222/0927U).  On 25-JUN-2008 the patient went to bed and woke up four times that evening complaining of numbness in the left arm and weakness.  She developed a rash on both arms from wrist to elbows the next day on 26-JUN-2008.  The numbness and weakness resolved the next morning.  At the time of reporting, the outcome of the rash on both arms from wrist to elbows was unknown.  It was not specified if there was an illness at the time of vaccination.  No further information is available.
Sharp pains in middle of chest next day roughly 12 hours after. Shortness of breath after shots. Fever and high blood pressure: 131/84 - temp: 101 (both day after). Insomnia - awake since 1am
This spontaneous report was received from a licensed vocational nurse and refers to multiple unspecified patients of unknown age and gender. The patients' pertinent medical history and concurrent conditions were not provided. On 16-FEB-2016, 17-FEB-2016 or 18-FEB-2016, the patients were vaccinated with VAQTA lot # L023232, expiration date 25-FEB-2017 (dose and route were not provided). Concomitant therapy information was not provided. On 16-FEB-2016, 17-FEB-2016 or 18-FEB-2016, there was an incorrect product storage as multiple unspecified patients received VAQTA that were improperly stored. No adverse events were reported. The highest temperature for the reported excursion was 48.32 F and it was during the time frame of 25 minutes. There was no previous temperature excursion. The call to report this information was because of a data logger. It was unknown if the patients sought medical attention. At the time of the report, the patients' status was unknown. This is one of several reports received from the same source. Additional information has been requested.
Swelling of vaccination site, development of hard bump approx. 1/25" and red ring rash approx. 3 1/2" around vaccination site.
Severe shaking, fever, for several hours, took a TYLENOL, fever broke.
Systemic: Fainting / Unresponsive-Severe, Systemic: Seizure-Severe
coughing; runny nose; chest congestion; sore left arm; headache; fever; Vaccination failure; COVID-19 confirmed by positive COVID-19 test; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 16Mar2021 (Lot number: FN9166) at the age of 54 years as dose 1, single and administration date 06Apr2021 (Lot number: FN6207) as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 2021, outcome "unknown", described as "Vaccination failure"; COVID-19 (medically significant) with onset 2021, outcome "unknown", described as "COVID-19 confirmed by positive COVID-19 test"; CHEST DISCOMFORT (non-serious) with onset 26Oct2021, outcome "not recovered", described as "chest congestion"; RHINORRHOEA (non-serious) with onset 29Oct2021, outcome "not recovered", described as "runny nose"; COUGH (non-serious) with onset 01Nov2021, outcome "not recovered", described as "coughing"; PAIN IN EXTREMITY (non-serious) with onset Apr2021, outcome "recovered" (Apr2021), described as "sore left arm"; HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "headache"; PYREXIA (non-serious) with onset 2021, outcome "unknown", described as "fever". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive. the patient stated that two weeks prior to Halloween he had the same symptoms as he had when he tested positive for Covid. Therapeutic measures were taken as a result of rhinorrhoea, headache, pyrexia. The patient was treated with over-the-counter Dayquil for all symptoms of headache, fever and runny nose. Caller stated that his provider told him to call this number if he had unusual effects from the booster shot. Stated that compared to the last shot that the amount of pain on left side where he got the shot from head to toe. Stated that is was not as severe from second shot that he had for his sore left arm back in Apr. Stated that the pain from the booster is more severe and lasted a lot longer. Stated that he did the right on his first shot. Is for the Covid 19. Wanted to know if coughing was symptom. Event details: Stated that the second shot sore arm resolved 09Apr or 10Apr. Recovered completely. Stated today is the first day he is trying to function from pain from booster shot. Stated that two weeks prior to Halloween that he had the same symptoms as he had when he tested positive for Covid. Treatment: Stated that he took over the counter Dayquil for all symptoms of headache, fever and runny nose. Product details: Stated that his second shot was on 06Apr2021. Provided a lot number of FN6207. Does not provide an NDC or expiration date. Stated that the first Covid 19 shot was on 16Mar2021. Provided a lot number of FN9166. Does not provide a NDC or expiration date.   Follow-up attempts are completed. No further information is expected.
the cold; sore throat; fever; rash at the injection site; hard at the injection site; red at the injection site; This case was reported by a consumer via call center representative and described the occurrence of cold in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24th July 2019, the patient received the 1st dose of Shingrix .5 ml. On an unknown date, less than a week after receiving Shingrix, the patient experienced cold, sore throat, fever, injection site rash, injection site induration and injection site erythema. On an unknown date, the outcome of the cold, sore throat, fever, injection site rash, injection site induration and injection site erythema were not recovered/not resolved.   It was unknown if the reporter considered the cold, sore throat, fever, injection site rash, injection site induration and injection site erythema to be related to Shingrix.  Additional details were provided as follows: Last Wednesday from the date of reporting, the patient received a dose of Shingrix. The patient experienced the cold, sore throat and fever.  The patient took medicine and it was better but she was having these symptoms at the time of this report.  The patient had rash where she got the shot, and It was growing below the site of injection. It grew 4 to 5 inches long and 3 inches wide. It all red and it did not itch. The patient visited her physician to made sure it was not shingles.  At the time of this report, the patient also had some hardness at the injection site. There is a discrepancy between the outcome reported in the structured field (not recovered) and the outcome reported in the source document (recovering).
rash at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (rash at the injection site) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE RASH (rash at the injection site). At the time of the report, VACCINATION SITE RASH (rash at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
Information has been received from a physician concerning a 70 year old male patient who on 11-MAR-2009 was vaccinated with a dose of ZOSTAVAX (Oka/Merck) (Lot# 663893/0128Y) 065ml. Concomitant therapy include "multiple medications". After received the vaccine the patient experienced swelling and redness at the injection site. Patient then experienced fever of 103.8. On 18-MAR-2009 the patient was admitted to the hospital and. On 19-MAR-2009 the patient was operated and had abscess. At the time of the report on 20-MAR-2009 the patient was not recovered and was still in the hospital. Swelling, redness, fever and abscess were considered to be disabling and an other important medical event for surgery. Additional information has been requested.
Patient received the Janssen covid vaccine this morning.  Patient woke up from a nap in the afternoon covered in hives with bubbling at the injection site.  Patient was instructed to go the nearest ER.  Patient was instructed by vaccine immunizer to wait  an additional 15 minutes on top of regular 15 minute wait time due to allergy history.  Patient left without any issues at the store.
Developed Covid 19 7 days after getting vaccine  Cough, chills, fever, nasal congestion, headache, loss of taste, pain behind eyes, sore throat, body aches.
During a review of records, it was found that there might have been a possible temperature excursion with how the vaccine was stored with our mobile vendor.
He gave it to me quite high and in the right deltoid and I felt an immediate like a Nerve reaction going up to my neck and then that went away and that went through my arm into my hand.; Right now my whole upper arm is really sore; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administered in deltoid right (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Single), for COVID-19 immunization. The following information was reported: FEELING ABNORMAL (non-serious), outcome "unknown", described as "He gave it to me quite high and in the right deltoid and I felt an immediate like a Nerve reaction going up to my neck and then that went away and that went through my arm into my hand."; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "Right now my whole upper arm is really sore". Additional information: The patient was wondering, and got the second dose of vaccine. The patient was a Nurse and knew a little bit about this 'Covid' vaccine. The patient got vaccine quite high and in the right deltoid and felt an immediate like a nerve reaction going up to the neck and then that went away and that went through the arm into the hand. At the time of report, the whole upper arm was really sore. At the time of report, to look at the injection site, it was fine. That does not hurt. So, the patient did not knew to take some Tylenol or Ibuprofen or something and queried whether it was contraindicated right after. Further information could not be probed as the Nurse did not want to share further information. Limited information was available over the call.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
expired FLUZONE HIGH DOSE was accidentally administered to a patient (with no adverse event); Initial information received on 04-Oct-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 66 years old female patient who received expired Influenza Quadrival A-B High Dose Hv Vaccine [Fluzone High-Dose Quadrivalent] accidentally (with no adverse event).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 02-Oct-2023, the patient received expired dose of 0.7 ml suspect Influenza Quadrival A-B High Dose Hv Vaccine (strength, formulation and expiry date : unknown, lot UT7743CA) via intramuscular route in the left deltoid as immunization (expired product administered) (latency: same day).  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.
got first shot / Within 2 days I had Shingles; This case was reported by a consumer and described the occurrence of shingles in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received Shingrix at local VA and within 2 days had shingles. When notified the Doctor was told it was a coincidence.
The day after I received my vaccine, a large swollen hemorrhoids appears on my rectal out of the blue. I had no constipation and didn?t except this happen to me after vaccine. I have been having bleeding for more than a week now and it is not getting any better
Cold chills, body aches, possible fever throughout night. Sinus pressure and dehydration. Resolved the next day.
Patient was given Tdap last year 6/17/13, and then given Tdap again this year on 6/17/14.
Breast swelling/growth (NOT lymphnodes, the actual breast tissue). Breasts swollen one cup size (1+ inches) and very tender. Nipple tenderness. Both are very uncomfortable. Abdominal discomfort that feels like period cramps. I am NOT on hormonal birth control.
chills, strong muscle pain, heart palpitation/ possible heart burn, headache, warmer temperature but not fever (99.5 F).
rashes on face, puffy, itchy and redness on face only Then @ 2am 2/21/2010 itchy and redness all over face and body.
Severe left arm pain at injection site. Pain radiates to the neck and back.  Patient unable to lift arm >90 degrees in any direction without severe, shooting pain.  Initially treated with PT fro presumed frozen shoulder.  Patient came to see me without any improvement after several treatments.  We shifted treatment to presumed diagnosis of macrophagic myofasciitis given her symptoms and patient has started to improve.  Currently at 50% improvement in subjective pain and able to lift arm > 90 degrees in abduction, but not flexion.