chrisvoncsefalvay/vaers-outcomes huggingface dataset:
100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again; No Adverse Event; 100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again), PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and NO ADVERSE EVENT (No Adverse Event) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 11-Jan-2023, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again), PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again).    No concomitant medications were reported. No treatment medications were reported.  This case contains information for the 72nd of 100 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-697752 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-697752:Master case
local rxn, very fussy;pain @ site, remarkable tenderness, erythema;temp this AM 102 ax @ home;seen in MD office 10/20/99 3PM;rt leg reaction;
A report has been received from a Health Professional concerning, female patient. The relevant history and concomitant disease of the patient were not reported. The concomitant medications of the patient were not provided. On an unknown date, the patient got nasal FLUMIST last season (2012-2013) and FLUMIST did not protect her from getting the flu. The patient tested positive for the flu and had the flu after receiving FLUMIST. Also it was reported that the patient received FLUMIST in Aug-2012 or Sep-2012 and became ill in October. Action taken with influenza virus vaccine live, intranasal was unknown and the outcome of the event of patient tested positive for flu after receiving FLUMIST and had the flu was recovered. The report was considered to be non-serious by the reporter.
This spontaneous report was received from a medical assistant refers to an unspecified number of patients of an unknown age and gender. Medical history was not reported. The medical assistant informed that on an unspecified date in October 2014 the patients were vaccinated with improperly stored doses of ROTATEQ (route, lot number, expiration date and dosage were not reported). No symptoms reported. The outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Chills and then hot. Horrible headache. Very tired. Light sensitive. Clammy skin. I did not have a thermometer but assume I had a fever. I was a little better on third day but headaches and sensitive to light lasted about 10 days.
Complaint/Assessment: Seen yesterday for leukocytosis - instructed to return today for repeat cbc. HPI/ROS: feels some better today but still running fever to 130 over night -- seen yesterday for fever (per pt home temp up to 102 -- body aches -- wbc 20,000 with L shift -- cxr neg -- ID called no tx recommended.. but to return. This am for re-evaluation and repeat labs.. pt got PNEUMOVAX in L deltoid on Monday and flu shot in R deltoid same day -- L deltoid is slight swollen -- warm to touch,, TTp .. pt denies sick exposures -- no cough - sore throat or dysuria -- no abd pain - no n/v or diarrhea -- no traveling. Redness and warmth at injection site; flu sx
R arm very sore from 10/22/03 post shot until end of January, 2004. Pt took Aleve 500mg in am and 400mg at for x 5 days then took Prednisone 10mg. 5, 5, 4, 4, 3, 3, 2, 2, 1, 1, then had physical therapy x 6. Inflammation/ irritation in tendon of R lateral deltoid region.
Less than 24 hours after receiving the shingles vaccine, the injection site started to swell, turn red, small red bumps began to appear, and the injection site began to weep/leak fluid.   It looks worse now that it's been a week since I've received the vaccine.   The injection site is still painful to the touch.
Nauseous, dizzy, my arm doubled in size and is incredibly tender/painful, my head hurts, things smell like blood, and my throat hurts.
Pt received Moderna prime on 4/2/2021 at a Medical Center. Pt denied history of vaccine in 2 weeks and denied ever having a COVID vaccine prior to receiving his scheduled Janssen vaccine on 4/7/2021. Contraindications denied. Pt was administered the Janssen vaccine without any complications noted. Upon inputting vaccines into KYIR we discovered the history. Vaccine was confirmed on 4/9/21.
Within hours are the shot, the migraine aurora started which is a clear indication that I am about to have a migraine attack   I had heard we were not supposed to take aspirin or similar products so I was concerned I would not be able to take my migraine medication (sumatriptan) to prevent a full on migraine.,  Since I need to take my Sumatriptan within 30 minutes after the aurora stops, I needed to get advice quickly. I knew my primary physician would not be able to meet the time constraints so I called the Emergency Department.  I spoke with a Physician's Assistant, I do not remember her name. I explained what was happening and that I do, from time to time, get migraines, she advised me to go ahead and administer the Sumatriptan Nasal Spray as I would normally.  Which I did immediately after I hung up the telephone, which was approximately 2:15 PM.    While I never got a full blown migraine, I did get the migraine funk, brain fog, sore arm  and was totally fatigued . I was completely wiped out for about 2 days. I stayed in bed for those 2 days,
Pt. describes feeling nauseated and having diarrhea the evening of 01/20/2007.  He "almost passed out",so decided to call 911 to go to the emer. dept.  Was seen at ER; V/S within normal limits, except "BP was low". Was given IVF, and a rx for "something for the diarrhea", which pt. didn't have filled.  Had some residual nausea and a little diarrhea the next day, but did go to work on Monday.  Is planning to go to see his PCP next Wed. Requested pt. call back to give an update.
woke about 5am day after receiving 2nd shot with pain at injection site, headache, swelling /pain under left arm,  pain/ache in left leg, and redness  and hardness around injection site. I took two doses of aspirin and one dose of cold & flu medicine during the day (4/7) and one dose of liquid cold & flu medicine before bedtime.  4/8 - fever and headache gone, still have the rest of the side effects, took aspirin at bedtime for leg pain.  4/9 - still have rest of side effects, took aspirin at bedtime for leg pain.  4/10 -4/12 - leg pain gone, still mild pain at injection site and underarm still swollen with mild pain.  4/13 - all side effects gone.
COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 05Oct2022 at 17:30 as dose number unknown (booster), single (Lot number: GJ6665), in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 13Apr2022 as dose number unknown, single (Lot number: FK9893), in left arm for covid-19 immunisation. The patient had no relevant medical history and no known allergies. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 02Mar2023 to 07Mar2023. The patient never tested negative.
sore right injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore right injection site arm) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination.     The patient's past medical history included Fusion cervical spine (Lumbar 3 and 4) in 2008.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced VACCINATION SITE PAIN (sore right injection site arm). On 13-Mar-2021, VACCINATION SITE PAIN (sore right injection site arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medication was reported. The treatment information was not provided.   This case was linked to MOD-2021-260351 (Patient Link).
antibodies response was not present; This case was reported by a consumer via other manufacturer and described the occurrence of therapy non-responder in a female patient who received HBV (Engerix B) (batch number 9232L, expiry date unknown) for prophylaxis.   Co-suspect products included HBV (Engerix B) for prophylaxis and HBV (Engerix B) for prophylaxis.   On 1st November 2018, the patient received the 1st dose of Engerix B 1 ml. On an unknown date, the patient received the 2nd dose of Engerix B and the 3rd dose of Engerix B. On 20th May 2022, 1296 days after receiving Engerix B and unknown after receiving Engerix B and Engerix B, the patient experienced therapy non-responder. On an unknown date, the outcome of the therapy non-responder was unknown.       Additional Information: GSK receipt date: 13-June-2022 Reporter's comment: The case was reported by patient. The patient stated that she received her 1st dose from health care provider and followed proper dosing schedule as per health care provider instruction. On 20th May 2022, the patient was tested her antibodies and told to her that Hepatitis B response was not present. No other information reported, no PQC reported. Additional Supportive Information: The patient's hepatitis B antibodies were negative which led to therapy non responder.
Severe chills, muscle aches, shooting pains in calves, hamstrings and back, rash on neck and side, spotting and blood clots coming from vagina when not time for regular mensural cycle, abdominal cramping, severe headache, flashing light when closing eyes, tenderness and pain under armpits, nausea all lasting over a week after vaccine.
Unable to comprehend description of movie displayed on monitor/did not make convey idea, but each word was understood; word finding difficulty; Medical history included Crohn's and prostate cancer (CA)/vedolizumab (ENTYVIO); Medical history included Crohn's and prostate cancer (CA)/vedolizumab (ENTYVIO); This is a spontaneous report from a contactable consumer (patient). A 74-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: El1283), via an unspecified route of administration, left arm, first dose on 09Jan2021 16:00 at a single dose and for COVID-19 immunization. Medical history included Crohn's and prostate cancer (CA). The patient has no known allergies. Concomitant medication included celecoxib, vedolizumab (ENTYVIO), vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]) and vitamin b complex. The patient also takes "garlic multi". The patient had no other vaccine in four weeks. The patient has no COVID prior to vaccination. Covid test via nasal swab on 11Jan2021 with result of negative. On 11Jan2021 at 19:30, the patient was unable to comprehend description of movie displayed on monitor. Words did not make convey idea, but each word was understood. The patient went to hospital for transient ischaemic attack (TIA), no findings overnight then at home word finding difficult about 12 hours later (Jan2021). The patient was brought back to the hospital, no evidence of TIA or cerebrovascular accident (CVA). The adverse events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care and hospitalization for four days. The patient recovered with lasting effects. The patient had MRI, CT and ECHO with unknown results in Jan2021. The patient received statins, topiramate magnesium infusion as treatment. The patient received the second dose (lot number: El9265) via an unspecified route of administration, right arm on 30Jan2021 for COVID-19 immunization.
Patient was seen at office for 4 year well child visit and given routine 4 year vaccines (MMRV, Quadracel) Patient was fine after the vaccinations and left the office. On the way to school mom states she was trying to get patient's attentions and he was passed out and he urinated on himself during the episode in the car.  Episode lasted 30 seconds. He dropped his head and during the episode his arms went up "like he was dabbing".  When they arrived here his lips were pale, he was awake and alert.  He was oriented in office with normal vitals.  He was observed for 10-15 minutes and was stating he wanted to go home.
chest pain/experienced chest pain, but it was more like a radiating pain that also effected their neck and arm; chest pain/experienced chest pain, but it was more like a radiating pain that also effected their neck and arm; chest pain/experienced chest pain, but it was more like a radiating pain that also effected their neck and arm; chest pain/experienced chest pain, but it was more like a radiating pain that also effected their neck and arm; patient had some of the symptoms of the myocarditis or pericarditis; patient had some of the symptoms of the myocarditis or pericarditis; This is a spontaneous report from a contactable pharmacist. A 33-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, Batch/Lot Batch/Lot number was not reported) via an unspecified route of administration and administered in left arm on 07Jun2021 (at age of 33 -years-old) as first dose 0.3 ml, single dose for COVID-19 immunization get protection from covid 19. The patient medical history and concomitant medications were not reported. Caller was a pharmacist calling on behalf of her patient who received the first dose of the Pfizer-BioNTech COVID19 vaccine on 7 Jun 2021 and experienced chest pain, but it was more like a radiating pain that also effected their neck and arm on the same day of vaccination. The patient came in to get their second dose. patient had some of the symptoms of the myocarditis or pericarditis. He was supposed to get the vaccine on Monday (28 Jun 2021) but caller said she wanted to talk to Pfizer to see if we had any recommendations on getting the second dose with a potential of having myocarditis or pericarditis. The chest pain lasted 3-4 days and was improved. Investigations as the caller does not think the patient had any tests done as he didn't seek any medical attention about this. Outcome of the chest pain was recovered on unspecified date in 2021 and other events was unknown. Reporter seriousness for chest pain but it was more like a radiating pain that also effected their neck and arm as Not serious and assessed as Related.  Information on the lot/batch, further information has been requested.; Sender's Comments: As there is limited information in the case provided, the causal association between the events Myocarditis and Pericarditis and the suspect drug bnt162b2 cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of 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 regulatory authorities, Ethics Committees, and Investigators, as appropriate.
sore arm; pain in arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (sore arm) and PAIN IN EXTREMITY (pain in arm) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included AMLODIPINE and OLMESARTAN for Blood pressure management.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Jan-2021, the patient experienced MYALGIA (sore arm) and PAIN IN EXTREMITY (pain in arm). On 02-Feb-2021, MYALGIA (sore arm) and PAIN IN EXTREMITY (pain in arm) 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.   Mexican yan harmone supplement pills were taken as concomitant medication along with others, as specified by the reporter. Treatment with Advil was taken pertained to the symptoms experienced.
bleeding from the penis; This is a spontaneous report from a contactable Nurse.  A 78-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot EL0142, via an unspecified route of administration in left arm on 05Jan2021 at single dose for covid-19 immunisation.  Medical history included fracture displacement on 23Dec2020, atrial fibrillation, non-hodgkin's lymphoma, post surgical ortho care, semen bleeding, from an unknown date and unknown if ongoing, Covid positive on 06Nov2020 (he was Covid positive before and didn't want to get it again and give it to his wife). There were no concomitant medications.  The patient underwent lab tests and procedures which included Covid test positive on 06Nov2020. The patient experienced bleeding from the penis on an unspecified date with outcome of unknown.  Nurse wanted to know if there is information about interactions between blood thinners and the vaccine.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the event penile haemorrhage cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. Of note, semen bleeding was reported as medical history and no concomitant medications were reported; hence, the role of other possible medical conditions or medications cannot be ruled out. This case will be reassessed once additional information becomes available. 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 Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Extremely painful and prolonged menses beginning 3/2022 and continuing through 6/2022. Former length of menses was 1-2 days; current length is 4 days. Crippling cramping every day of menses; cramping does not taper off, but rather gets stronger throughout menses. Length of cycle previously was 27 days with very small variation; since 3/2022, cycle length has varied from 26 days to 30 days.
9 cm x 6 cm reddened and swollen area (R) deltoid arm
Stabbing head pain for 2 days after shot, shortness of breath for 2 days after shot, prolonged leg pain 1+week after shot
This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (she was dizzy on 2nd day) and HEADACHE (she having headaches and so forth and she is still getting some but  it might be allergies) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Sinusitis since an unknown date. Concurrent medical conditions included Allergy (Bad Allergies).    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 DIZZINESS (she was dizzy on 2nd day) and HEADACHE (she having headaches and so forth and she is still getting some but it might be allergies). At the time of the report, DIZZINESS (she was dizzy on 2nd day) and HEADACHE (she having headaches and so forth and she is still getting some but it might be allergies) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Treatment medications were provided No Concomitant medications were provided
10 days after the shot I got basic flu like symptoms. Body ache, mild head ache, chills, fatigue, but NO fever. These symptoms lasted about four hours.
I have had mild and apparently typical adverse reactions to all four Moderna Covid vaccines - which lasted less than a day each time. I contracted Covid on 16Oct22. I called my doctor and they set up a Telehealth consultation . We discussed my symptoms and status to determine if an anti-viral medication was warranted. Ultimately I did not get the medicine and got better myself after about two weeks. I do not seem to have any lasting issues. I am very happy to have gotten the vaccines!
Had yellow fever vaccine 7/7/07 developed headache evening of 7/7/07. Developed headache evening of 7/7/07 which lasted until evening 7/10/07 - pain relieved with Motrin.
high temperature; body aches; headache; This is a spontaneous report from a contactable consumer (patient) or other non hcp via Pfizer Sponsored Program.  A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. On an unspecified date, the patient received second dose of COVID vaccine 24 hours ago and experiencing high temperature, body aches and headache. She was wondering when she can take something for it. The outcome of the event was unknown.  No follow-up attempts were possible. Information about batch number cannot be obtained; no further information was expected.