chrisvoncsefalvay/vaers-outcomes huggingface dataset:
GI Problems; This is a spontaneous report from a contactable consumer. This 71-year-old female consumer reported that:  A 71-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 04Feb2021 as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced gi problems, off-label dosing schedule. Would the 2nd dose be bigger. Patient asked about the timing of the second dose beyond the 3 weeks. It was scheduled to have and endoscopy with anesthesia on 24Feb2021 (a day before second shot). Patient mentioned that she read that the anesthesia may lower the immune response, so Caller wanted to know the vaccine on the 25Feb2021 and should even get anesthesia. At the time of report. the outcome of events were unknown.  Lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
sore arm; This is a spontaneous report from a contactable consumer reported for herself. A 73-year-old female patient receive the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 25Jan2021 at arm at single dose for COVID-19 immunization. Medical history and concomitant medication were not reported. patient asking if one have a sore arm, are one allowed to take Ibuprofen. Female consumer received the first dose of the COVID-19 vaccine today and had a sore arm (25Jan2021). When she received the vaccine, it was administered closer to her shoulder. patient asked what does intramuscularly mean. Outcome of the event was unknown. It was a non-serious report.  Information on the lot/batch number has been requested.
Loss of eye contact, loss of communication, would not respond if his name was called, strange fascinations, staring off into space. 3mths. Later we were referred to Infants and Toddlers Program for an evaluation.
Arm became painful 4 hours after vaccine. Patient iced the area. Observed two red areas one 5cent size, one 25 cent size about 2 inches below vaccine site on Wednesday 10/25/06 on waking also noted "puffiness" but pain had improved. Reported to me at 10:00 am on 10/25/06.
Severe pain: right arm, axillary chest shoulder, jaw , lethargy, syncopal episodes
Shortness of Breath Possible sleep apnea Shortess of breath while sleeping , sometimes during the day regular activity
Clinic nurse administered the Janssen vaccine to a 17 year old female in an offsite clinic. Administration error was not caught until the client left the building after waiting 15 minutes post vaccination. No complications/reactions noted at the time.
On Friday, October 29, 2021 at approximately 8:00 AM, I experienced similar arm pain as I had in the previous two Pfizer vaccinations.  At approximately 6:00 PM, I started to experience partial paralysis of my left hand.  I would have to physically manipulate my left hand with my right.  On Saturday, October 30, 2021, I woke up at approximately 3:00 AM with significant arm pain from my left rear shoulder radiatiing down my left arm, wrapping around my forearm to my hand.  The paralysis had stopped and my complete left hand was numb.  To date (Tuesday, November 9, 2021 at 7:50 PM), there has been no improvement.  I did take three vidocin over a 18 hour period w/o any relief.  I have been taking 600mg ibuprofen for three days w/o any relief.  I went to a chiropractor on Monday, November 8, 2021 at 2:05 PM hoping it was a nerve that an adjustment would help.  I went a second time to my chiropractor on Tuesday, November 9, 2021 at 2:20 PM.  As of now I have no relief, with significant left rear shoulder and left arm pain that radiates from the shoulder.  I still have complete numbness of my left hand.
Headache, very fatigued, muscle aches, dizziness, light headed, cold type symptoms, runny nose, stuffy sinuses, sore arm Lethargic Started Sat 3/27 morning. Not really improved until this morning 3/31
Dizzy; today I feel much dizzy that is kind of worse; Feeling dizzy; dizziness went worse affected my life because I can't focus on my study work; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 24 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 17May2021 (Lot number: EW0187, Expiration Date: Aug2021) at the age of 23 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DIZZINESS (non-serious), outcome "unknown", described as "Dizzy"; CONDITION AGGRAVATED (non-serious), outcome "unknown", described as "today I feel much dizzy that is kind of worse"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious), outcome "unknown", described as "Feeling dizzy; dizziness went worse affected my life because I can't focus on my study work". The action taken for bnt162b2 was unknown. Additional information- It was reported that patient took  first Pfizer shot on May 17th (2021) and she started to feel dizzy she would like to know if the real life do not affect after the vaccine. Yesterday afternoon her dizziness went worse like affected my life because she can't focus on my study work. She was  really feeling dizzy and she thought  she need to take the rest.  No follow-up attempts are possible. No further information is expected.
Does not like the taste of food after 2nd shot; Does not have desire to eat after 2nd shot, does not have any Appetite after 2nd shot; Loosing weight (-59lbs) after 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of TASTE DISORDER (Does not like the taste of food after 2nd shot), DECREASED APPETITE (Does not have desire to eat after 2nd shot, does not have any Appetite after 2nd shot) and WEIGHT DECREASED (Loosing weight (-59lbs) after 2nd dose) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006C21A and 006C21A) for COVID-19 vaccination.     The patient's past medical history included Hypoxia, Fibromyalgia, Arthritis, Lumbar pain, Back pain, Scoliosis and Carpal tunnel syndrome. Concurrent medical conditions included Acute respiratory failure, Aortic aneurysm, Spinal stenosis, Barrett's oesophagus, BPH, Cardiomyopathy, COPD, Coronary artery disease, Coronary atherosclerosis, Epilepsy, GERD, Hyperlipidemia, Hypertension, Obesity, Myocardial infarction, Migraine, Neuropathy NOS, Restless leg syndrome, Neurofibromatosis and Sleep apnea. Concomitant products included LEVETIRACETAM, POTASSIUM CHLORIDE, GABAPENTIN, FUROSEMIDE, VALPROATE SEMISODIUM (DIVALPROEX), CARVEDILOL, TAMSULOSIN, PANTOPRAZOLE, BACLOFEN, AMITRIPTYLINE, CLOPIDOGREL, CITALOPRAM, ATORVASTATIN, AMLODIPINE, DICLOFENAC and PRAMIPEXOLE for an unknown indication.   On 14-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Jun-2021, the patient experienced TASTE DISORDER (Does not like the taste of food after 2nd shot), DECREASED APPETITE (Does not have desire to eat after 2nd shot, does not have any Appetite after 2nd shot) and WEIGHT DECREASED (Loosing weight (-59lbs) after 2nd dose). On 17-Oct-2021, WEIGHT DECREASED (Loosing weight (-59lbs) after 2nd dose) had resolved. At the time of the report, TASTE DISORDER (Does not like the taste of food after 2nd shot) and DECREASED APPETITE (Does not have desire to eat after 2nd shot, does not have any Appetite after 2nd shot) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative COVID-19 test.         No Treatment Information were provided by the reporter  Reporter stated that after the second shot, patient does not have any Appetite, patient is loosing weight (He is 5'7" and was 316lbs prior to Vaccination). patient  weighs 257 Lbs. now 17OCT2021.patient  states that he can taste the food, but  does not like the taste any more and has no desire to eat  and he is late for the church and can not hang on too long.
Provider administered covid-19 Bivalent Booster 0.2mL (NDC 80777-0283-99) yellow box pink lid instead of Moderna Bivalent dose 0.25mL (NDC 8077-252-99) gray booster dose blue lid as first dose in primary series. No adverse rxn.
Body aches, fever, chills generally flu-like symptoms lasting more than 24 hours. Also, swelling and redness at vaccination site.
Right thigh area red, warm to touch, area measures 10 cm by 12 cm.
My arm did hurt the same day of the flu shot. But it didn't really start to hurt awful til about a week later. I was on TYLENOL with codeine for a root canal that I had done - when the pain medicine was out of my system - that's when my arm started hurting - and still does!
Administered immunization with manufacturer expiration of 9/30. However, Information has been received from the manufacturer indicating that stability data supports the use of this product through Oct. 19.
MA mistakingly gave a pregnant patient preservative free Flublok instead of preservative free Fluzone Quad/no AE; MA mistakingly gave a pregnant patient preservative free Flublok instead of preservative free Fluzone Quad/no AE; Initial pregnancy information received on 20-Sep-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to cases 2019SA266135, 2019SA266138 and 2019SA266137 (same reporter).  This case involves a 39 years old female patient who was mistakenly exposed to preservative free vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] instead of preservative free INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] while she was pregnant.  Patient's gestation period at onset and gestation period at exposure was 3 weeks, the date of last menstrual period was 28-DEC-2018 and the estimated due date is 12-NOV-2019.  The patient's past medical history, previous pregnancy/ies, medical treatment(s), vaccination(s) and family history were not provided.  Patient was not on any concomitant therapy. . On 20-Sep-2019, the patient received a 0.5 ml single dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot number 16-DEC-2019 via unknown route in the right deltoid.  It was a case of actual medication error due to wrong vaccine administered (Wrong product administered).  It was reported that patient did not experience any adverse event at the time of reporting.  Additionally, at time of reporting, the outcome of the pregnancy was unknown because patient's delivery due date is on 12-NOV-2019.  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 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.
1/8/21 cough, fatigue, HA, wheezing, rhinorrhea
the first made my arm sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "the first made my arm sore".  Follow Up#1 Information (07pr2021) This is a spontaneous report from a contactable Consumer. This Female consumer reported that: This sounds odd but the second Pfizer shot was totally different from the first. Needle seemed smaller. Sort of like the flu shot you would get at a doctor's office. Bandaid seemed to go on first (which makes no sense) and I didn't see the  needle go in. No reaction while the first made my arm sore. Hours later nothing. Pharmacy said this is normal. Just commenting  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Patient states he experienced some numbness around injection site. A strip of area about 3-4 inches long and about an inch wide laterally across injection site.
soreness in the arm; day I felt not so good/feel a bit off; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included COVID-19 VACCINE (COVID VACCINE) for prophylaxis.   On an unknown date, the patient received Shingles vaccine (unknown arm) and COVID VACCINE (unknown arm). On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain in arm (Verbatim: soreness in the arm) and feeling unwell (Verbatim: day I felt not so good/feel a bit off).  The outcome of the pain in arm was not resolved and the outcome of the feeling unwell was resolved (duration 1 day).   It was unknown if the reporter considered the pain in arm and feeling unwell to be related to Shingles vaccine.     It was unknown if the company considered the pain in arm and feeling unwell to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 27-SEP-2023 This case was reported by consumer via (Facebook) interactive digital media. The reporter reported that he or she did not think that we could generalized these vaccination shots. The reporter never had a bad reaction but sometimes some soreness in the arm until his or her last shot last year which was the covid shot and one arm and Shingles in the other. The reporter reported that for one day he or she felt not so good but after that he or she was fine. Reporter asked question that which injection made him or her felt a bit off, who knowns. It was unknown if the reporter considered the pain in arm and feeling unwell to be related to Covid vaccine.
This spontaneous report was received from a pharmacist referring to a 66 year old female patient. Information about the patient's pertinent medical history, drug reactions/allergies and concomitant medications was not provided. On an unknown date the patient was vaccinated with an unspecified hepatitis b vaccine (manufacturer unknown), (route of administration, dose #, lot #, expiration date and indication were not provided). On an unknown date, the patient experienced rash and fever. No treatment was given. At the time of reporting the patient had recovered from the rash and fever. The reporter did not assess the relationship between the events and the hepatitis b vaccine (manufacturer unknown).
left arm was a little sore; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (left arm was a little sore) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.    Co-suspect product included non-company product INFLUENZA VACCINE (INFLUENZA) for an unknown indication.    No Medical History information was reported.   On an unknown date, 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 and dose of INFLUENZA VACCINE (INFLUENZA) (unknown route) at an unspecified dose. On an unknown date, the patient experienced PAIN IN EXTREMITY (left arm was a little sore). At the time of the report, PAIN IN EXTREMITY (left arm was a little sore) outcome was unknown.            No relevant concomitant medications were reported.  Patient received annual flu shot and COVID-19 Moderna updated booster. No treatment information was provided.
Pt reported malaise, sweating, chills beginning on the morning after vaccine administration. Visual inspection of the arm where vaccine was administered had redness spread down the arm away from the injection site on 10/8/2017. Pt also reported having "dark urine". Pt was advised to seek medical attention and he went to the local urgent care on 10/8/2017 where he was evaluated by the physician there. Pt reported being told that the reaction he was experiencing was his body's immune response to the vaccine and a steroid injection was administered. Upon follow-up with the pt on 10/9/2017, pt states all is ok and he feels fine now.
Patient had COVID, then shingles a couple of days before his vaccination. 2 days after vaccination, patient had shingles again. patient met with his doctor, who told him not to get the 2nd Morderna covid-19 shot
On 20May2022, I tested positive for Covid and started to experience mild symptoms; On 20May2022, I tested positive for Covid and started to experience mild symptoms; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2 (Pfizer-BioNTech COVID-19), on 11Feb2021 as dose 1, single (Lot number: EN6201) at the age of 67 years, in right arm, on 04Mar2021 as dose 2, single (Lot number: EN6198) at the age of 67 years, in right arm, on 26Oct2021 as dose 3 (booster), single (Lot number: 3W308D) at the age of 68 years, in left arm and on 13Apr2022 at 14:00 as dose 4 (booster), single (Lot number: 4895) at the age of 68 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 20May2022, outcome "unknown" and all described as "On 20May2022, I tested positive for Covid and started to experience mild symptoms". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (29May2022) Positive; (20May2022) Positive; (25May2022) Negative. Therapeutic measures were taken as a result of vaccination failure, covid-19. Patient received Paxlovid to treated vaccination failure, covid-19. Treatment start date:20May2022, treatment stop date: 25May2022.
Suspected vaccination failure; Got it Shingle; This case was reported by a consumer via interactive digital media  and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was patient. The age at vaccination was not reported. The reporter stated that the shot did not keep you from getting Shingles .  The patient had the shingles shot but experienced shingles. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were not provided.
Headache, Fever, Diarrhea, NauseaVomiting &  HYPERtension Narrative:  received IV hydration, COVID-19 test which was negative
child recv vax & non vax child devel a fever & vomited once;28NOV95 devel vesicular lesions on abd,trunk,arms & head;50-70 lesions were noted which were small & approx 6 of them were the size of a dime;
LITTLE PAIN IN THE ARM; This spontaneous report received from a consumer via social media concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure no follow up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced little pain in the arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of little pain in the arm was not reported. This report was non-serious. This case, from the same reporter is linked to 20210503803.
Information has been received from a consumer concerning her 68 year old female friend with pre-existing lymphoma who in approximately December 2009, about 3 months ago, was vaccinated with a dose of ZOSTAVAX (Merck). On the same day the patient also was vaccinated with a dose of PNEUMOVAX 23 and a dose of influenza virus vaccine (unspecified) (manufacturer unknown). In approximately December 2009, four days after vaccination, the patient developed severe joint pain and joint swelling. The patient had recently received chemotherapy and radiation therapy before vaccination. The patient sought medical attention by visiting doctors. At the time of report the patient's status was not recovered. Follow-up information has been received from the 68 year old female consumer with lymphoma who in October 2009 was vaccinated with a dose of ZOSTAVAX (Merck) and a dose of influenza virus vaccine (unspecified) (manufacturer unknown). The patient reported she did read that ZOSTAVAX (Merck) was contraindicated for patients with a history of lymphoma, but her oncologist's office advised that it was ok for her to get the vaccine. Approximately 4 days later after getting the vaccines she developed flu like symptoms - aching, coughing up phlegm, runny nose, sore throat, etc. Her primary care physician prescribed antibiotics (name and manufacturer unspecified). She also developed joint pain and swelling in her knee, wrist and shoulder, shortness of breath, vomiting, abdominal pain and chills. She was diagnosed as possibly having rheumatoid arthritis and was given a cortisone shot (manufacturer unknown), which only relieved her symptoms for a few days. She was then diagnosed as possibly having Lyme disease. Now her physician thought either she had rheumatoid arthritis or her lymphoma had returned because of the results of a PET scan. At the time of report the patient's status was not recovered. Upon internal review, lymphoma was considered to be an other important medical event. No further information is available.
Went to ER on 2/5 with Shortness of breath and productive cough since first vaccine given. Diagnosed with hypoxemia, and COVID pneumonia. Admitted to hospital
on day of 8/25 felt fatigued in the afternoon, over the next two days had one or two emesis and one diarrhea.  There was one fever reported on 8/26.  on 8/27 patient was found to be hypotensive and in septic shock.  Currently as of today is on epinephrine infusion for hypotension.
Shortly after the vaccine she had a rash that improved with Benedryl. The day after she received the vaccine she began having a rash, itching, swollen tongue, dry mouth and throat tightness. She went to the ED and received a course of steroids.