chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 71-year-old female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2017-2018 season) for prophylaxis. In October 2017, the patient received Influenza vaccine Quadrivalent 2017-2018 season. On an unknown date, less than a year after receiving Influenza vaccine Quadrivalent 2017-2018 season, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown. It was unknown if the reporter considered the pain in arm to be related to Influenza vaccine Quadrivalent 2017-2018 season. Additional details were provided as follows: The patient received flu vaccine on left arm. The patient also mentioned that sometimes when she gets the flu vaccine (unknown manufacturer), her arm gets a little sore for a few days. This case has been linked with US2018130341, reported for the same patient.
on 3/18 blood pressure rose to 153/69 pulse 62.   No other symptoms.  Next morning 3/19 134/84 p 64.  by late afternoon was back up to 157/82 p 61.  Had bad headache.   3/20 @ 9:20 am 135/77 p 60.  3/20 @ 9:39pm 149/67 p64.  mild headaches.  3/21 9:30am 140/79 p64.  Went for a run, 30 mins after the run @2:33pm 135/80 p77.  Did not take evening reading on 3/21, but had mild headache in the evening.   3/22 @ 8:39 am 137/79 p 63.  no headache.  took motrin each day for headache.  Took benedryl at night to sleep.
soreness at his injection site; his hip, he could barely walk, his right hip / its still hurting; his hip, he could barely walk, his right hip / its still hurting; headaches; This is a spontaneous report from a contactable consumer (patient). This 68-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) first dose on 12Apr2021 Between 13:30 and 14:00 (NDC: Unknown, Expiry Date: Unknown) as single dose on Left arm for COVID-19 immunization. Medical History was None. Family Medical History RELEVANT to AE was No. Concomitant medications included the only medication he takes is the one he takes on a regular basis. No Additional Vaccines administered on SAME DATE of the Pfizer suspect. No History of all previous immunizations with the Pfizer vaccine considered as suspect. Prior Vaccinations within 4 weeks, no other vaccinations within four weeks prior to the first administration date of the suspect vaccine. The patient stated he didn't have any numbers on his vaccination card. He unsure of expiry date, NDC, or LOT.  He got Pfizer Covid Vaccine cause everybody else is getting it because of the virus. He stated that was okay he didn't need to be transferred if they can't give him recommendations, he would just call his doctor. He stated he had the shot on 12Apr2021 and he had some soreness in his injection site from 13Apr2021 and ongoing, he stated it was a little sore, but not like it was. But 13Apr2021 he had started experiencing his hip, he could barely walk, his right hip. He states it was still hurting, he could barely walk 14Apr2021 morning, just unbearable and persisting, it hasn't improved at all. He was also experiencing headaches from 13Apr2021 and ongoing. He tried to call Pfizer last night it lasted about 2 hours, and he just hung up and went on to bed. He stated he was just hurting, he didn't have any medical conditions. No AE require a visit to Emergency Room/Physician Office. Patient stated he hadn't gone yet, he probably was going to have to go if this pain keeps persisting. No Relevant Tests, he stated about two weeks ago he had some blood dram and they said it came back negative and he assumes everything was okay. Investigation Assessment was No. The outcome of the event (soreness at his injection site) was Recovering, of others was Not recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
lots of itching; who instructed her not to receive a second dose of the vaccine. And she has not received the second dose; Headache; Felt tired; Feeling like she was coming down with the flu or something; Hives; some diarrhea; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DIARRHOEA (some diarrhea), PRURITUS (lots of itching), URTICARIA (Hives), VACCINATION COMPLICATION (Feeling like she was coming down with the flu or something) and OFF LABEL USE (who instructed her not to receive a second dose of the vaccine. And she has not received the second dose) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy (Unspecified allergies).    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jan-2021, the patient experienced DIARRHOEA (some diarrhea). On 28-Jan-2021, the patient experienced URTICARIA (Hives). On 29-Jan-2021, the patient experienced VACCINATION COMPLICATION (Feeling like she was coming down with the flu or something), HEADACHE (Headache) and FATIGUE (Felt tired). On an unknown date, the patient experienced PRURITUS (lots of itching) and OFF LABEL USE (who instructed her not to receive a second dose of the vaccine. And she has not received the second dose). On 28-Jan-2021, URTICARIA (Hives) had resolved. At the time of the report, DIARRHOEA (some diarrhea), PRURITUS (lots of itching), VACCINATION COMPLICATION (Feeling like she was coming down with the flu or something), OFF LABEL USE (who instructed her not to receive a second dose of the vaccine. And she has not received the second dose), HEADACHE (Headache) and FATIGUE (Felt tired) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided.  Treatment information included Allergy medicine and Aspirin.  Allergist advised not to take Second dose of Vaccine.   Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: Batch number added, New events added, Onset dates updated, Outcome of the event Hives updated to recovered, Treatment information updated.
Severe diarrhea and throwing up at the same time. Started at 3:00am and lasted approximately 2 and a half hours.   It was horrible,
pt had second dose of covid vaccine (not sure which product).  The next day presented to the ed with SOB, tachycardia, temp 102.5.  Patient had myocardial infarction and subsequently passed away in the hospital on 4/25
none.  patient given dose of Rotateq that had expired 3 days prior to administration.
Sore right arm, chills and 101.9 fever, aches in back and neck, minor headache, fatigue
Vertigo like sypmtoms.   Nausea, loss of balance for 4 days.   Getting worse on day 3 but clearing up greately on day 4 with some foggyness.
This spontaneous report was received from a nurse refers to unspecified multiple patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions and concomitant therapies was reported. On unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD which had lot # M003436, expiry date: 19-JUL-2017; lot # L050910, expiry date: 14-JUN-2017 and lot # M001664, expiry date: 08-SEP-2017 (route, dose and anatomical place of vaccination were not provided). The vaccines with lot # M003436 and lot # L050910 were exposed to temperature of 41 degree Fahrenheit for 10 hours. While the vaccine with lot # M011664 was exposed to 40 degree degree Fahrenheit for 8 hours. Also, the vaccine had previous temperature excursion. The temperature excursions were detected by a data logger. No adverse effects were reported. At the time of this report, the vaccines were back in range. No product quality complaint (PQC) involved and no further information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
lt arm is red starting in upper arm muscles area & spreading down to the elbow;center appears whitish-green & red @ the edges;looks like a big target;no drainage;painful;19APR96 PC from mom;on ATB for cellulitis
fever 101-103 cont p/vax x 3 days;onset w/in 3hrs p/shot no other signs of illness x/irritability legs were unusually sore p/vax;refused to console x 24hrs
Pt had an allergic reaction hives on his face, swollen face. Gave him Benadryl. He had chicken noodle soup #3 approximately 3:00 or 3:30 that day.
8 doses given today after vial was punctured; This spontaneous case was reported by an other health care professional and describes the occurrence of INCORRECT DOSE ADMINISTERED (8 doses given today after vial was punctured) in a 39-year-old male patient 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Jun-2021, the patient experienced INCORRECT DOSE ADMINISTERED (8 doses given today after vial was punctured). At the time of the report, INCORRECT DOSE ADMINISTERED (8 doses given today after vial was punctured) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
EMT who administered the vaccine alerted me to swelling posterior to the injection site.  Vaccine appears to have been aimed at the posterior edge of left deltoid.  Skin laxity probably led to tracking subcutaneously.  Unclear how much of the vaccine was IM vs SQ.
15 month old male patient received expired dose of ACT-HIB vaccine with no reported AE; Initial information received on 30-Jun-2021 regarding an unsolicited valid non-serious case received from a other health professional via physician.  This case involves a 15 month old male patient who was administered an expired dose of HIB (PRP/T) VACCINE [ACT-HIB] (expired product administered).  Medical history, medical treatment, vaccination and family history were not provided.   Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A VACCINE) for Immunisation.  On 30-Jun-2021, the patient received a 0.5 ml dose of suspect HIB (PRP/T) VACCINE (lot UJ328ADA and expiry date: 29-Jun-2021) (Frequency: once) via an unknown route at an unknown administration site for prophylactic vaccination.  It was a case of actual medication error due to expired vaccine used (latency on same day).  It was also reported that Nurse reports that today (6/30/2021), a 15 month-old male child received an ACTHIB vaccine that was then noted to have expired yesterday.  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 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.
Intermittent coughing, swollen painful lymph nodes in groin, achiness in testicles, nausea, diarrhea.
W/in 1 1/2-2 mo p/recving repeat MMR developed numbness in hands & legs & 2 days later could not walk for 2 1/2-3 mo; Hospitalized for 2 mo (had plasmaphoresis done); 1mo rehabilitation;
Intense swelling of left arm, headaches, dizziness, elevated heart rate, possible neurological symptoms as well.   Headaches and dizziness continuing 6 days after vaccination.
Started complaining of pain on 3/19/03, it was swollen on 3/20/03 and itching. No bruising.
This is a spontaneous report from a contactable nurse (patient).  A 25-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EJ1685, via an unspecified route of administration in the right arm on 06Jan2021 12:00 at SINGLE DOSE for covid-19 immunization.  Medical history included systemic lupus, panic disorder, GERD (gastrooesophageal reflux disease) and covid-19 (Prior to vaccination, the patient was diagnosed with COVID-19). Concomitant medications included ethinylestradiol, ferrous fumarate, norethisterone acetate (JUNEL FE), omeprazole, fluoxetine, cetirizine hydrochloride (ZYRTEC).  The patient previously took lorabid and experienced allergies.  On 13Jan2021 17:00, the patient experienced fatigue, fever (101+), muscle aches, joint aches, nausea and headaches. The patient underwent lab tests and procedures on 14Jan2021 which included nasal swab: negative.  The outcome of events was recovered. Patient did not receive any treatment for the events. No follow-up attempts are possible. No further information is expected. Information on the batch/lot number has been obtained.
Headache, body ache, fever. Been about 24 hours and symptoms not totally gone.
This spontaneous report was received from a nurse practitioner refers to a unknown number of patient. The nurse practitioner reported that an unknown number of doses of PNEUMOVAX 23 that were improperly stored -5 degrees centigrade for 1 to 2 months, may have been administered. No concomitant medications were reported. No adverse effect was reported. It was unknown if the patients sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses were given after expiration date) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses were given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (doses were given after expiration date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  Date the vial was initially stored in the refrigerator was 22-Sep-2021. There was no temperature excursion. The reporter reported that that there was a confusion between the expiration date printed in the carton and the expiration date when the code was scanned.  The patient did not experience any adverse event.  No treatment information was provided by the reporter.
headache; Injection site pain; dizziness; fatigue; dizziness is so strong that he cannot stay stand up; feeling with little energy; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 61 year-old male patient received bnt162b2 (BNT162B2), administration date 02Mar2021 (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), for covid-19 immunisation. The following information was reported: HEADACHE (non-serious) with onset 03Mar2021, outcome "recovered" (2021), described as "headache"; VACCINATION SITE PAIN (non-serious) with onset 03Mar2021, outcome "recovered" (2021), described as "Injection site pain"; DIZZINESS (non-serious) with onset 03Mar2021, outcome "unknown", described as "dizziness"; FATIGUE (non-serious) with onset 03Mar2021, outcome "not recovered", described as "fatigue"; DIZZINESS POSTURAL (non-serious) with onset 03Mar2021, outcome "unknown", described as "dizziness is so strong that he cannot stay stand up"; ASTHENIA (non-serious) with onset 03Mar2021, outcome "unknown", described as "feeling with little energy". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
doses administered past the published expiry date; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date). On 22-Oct-2021, EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication details were not provided. Treatment details were not provided.
Oth complications following immunization, NEC, init on 2023-08-14.
Fever (103F) started at 8pm alond with chills and sever headache. Muscle aches and skin sensitivity also occurred with fever. Fever broke at 3am then started again at 8am. Tylenol taken every 6 hours for Fever.
Pt administered Pfizer 3 dose primary series and Moderna Booster.  Pt developed itching and redness in the eyes.  Pt carries her own benadryl and Epi.  Pt took benadryl 25mg PO @10:04 Vitals: 148/69, 70, 20, 100% @10:22 pt is feeling much better w/ ice packs applied to eye area.  @10:30 pt contacted husband to meet her at observation area prior to release from vaccination site @10:35 Pt stable and released from the vaccination site accompanied by husband.
tested positive for Covid-19 after receiving the Moderna vaccines.; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (tested positive for Covid-19 after receiving the Moderna vaccines.) in a 66-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7147B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 30-Sep-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 27-Jan-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced COVID-19 (tested positive for Covid-19 after receiving the Moderna vaccines.). On 03-Feb-2023, COVID-19 (tested positive for Covid-19 after receiving the Moderna vaccines.) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Jan-2023, SARS-CoV-2 test: Positive.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter did not provide any causality assessments.   Patient had not received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Patient received 1st Dose of Moderna COVID-19 vaccine on 26-Feb-2021 with lot no 011A21A, 2nd dose on 23-Mar-2021 with lot no 007B21A, 3rd booster dose administered on 02-Nov-2021 with lot no 032F21A. No concomitant medications were reported. No treatment details were reported.
Tinnitus; no treatment. Still experiencing tinnitus at the time of reporting (06.02.2021)
At the day of vaccine the only side effect was arm sore and tingling on the face. On 04/14/2021 I was at the doctors clinic for an appointment and suddenly felt tingling on the left side, temporal area, after some minutes start having rapid heart rate and blood pressure was high, felt lightheaded, weak. The symptoms last for few minutes.
Came in with his wife for them to both receive their covid boosters. I opened his wife's chart and brought them both back. I did not open his and document the vaccine prior to administering it. I administered both vaccines and went back to my computer to document and create their vaccine cards as they did not have them with them. Upon opening chart, which I should have done prior to administering and I take full responsibility for, I noticed that he had already had his 4th booster. I administered his 5th booster and also administered it too closely to his 4th booster. He received his 4th booster on 5/17/2022 and I gave him another booster on 7/14/2022. I apologized to both him and his wife. His wife did not receive her fourth and she was administered the correct amount. They both stated that they are not upset and are actually happy he was able to "get it early". I informed them that someone could be reaching out to them and they both stated they are okay with that and are not upset. I monitored patient for the period of his vaccine and patient felt fine.
Chills; Cold; Weak; lightheaded; Nausea; Vomited; Slight dizzy spell; Feeling pain under armpit; Swelling in arm/armpit; feeling pain on arm; Feeling tired; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0186) via an unspecified route of administration in the arm left on 21May2021 at 13:30 (at the age of 50-year-old) as a single dose for COVID-19 immunisation. Medical history included uterine fibroids, breast cyst (not being treated) and indigestion (can not digest raw vegetables and banana). Concomitant medications included 310 nutrition meal replacement protein powder (MANUFACTURER UNKNOWN). The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0175) via an unspecified route of administration in the arm left on 30Apr2021 at 13:30 (at the age of 50-year-old) as a single dose for COVID-19 immunisation. It was unknown whether the patient was diagnosed with COVID-19, prior to the vaccination. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 21May2021, after second dose patient felt ok but then in the evening, began feeling pain and swelling on arm and began feeling tired too. On 22May2021, Saturday night patient began feeling pain and swelling under armpit. On 23May2021 at 00:30, the following day on Sunday had a slight dizzy spell. On 24May2021 Monday, patient would not up dizzy with cold chills, weak and lightheaded with nausea, also vomited the water drank after patient woke up. This lasted all day and patient recovering and feeling somewhat better from everything at the time of this report. The 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 these events. The clinical outcome of the event swelling in arm/armpit, feeling tired, feeling pain on arm, feeling pain under armpit, slight dizzy spell, chills, cold, weak, lightheaded, nausea and vomited was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.