chrisvoncsefalvay/vaers-outcomes huggingface dataset:
All my joints making cracking noises. Pinky, fingers, knees, ankles, elbows. Odd. Not all the time but I crack a joint almost every hour. Been 2 weeks.; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old male patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number: UNKNOWN) via an unspecified route of administration on 09Mar2021 (at the age of 47-years-old), as a single dose for COVID-19 immunisation. Medical history and concomitant medication were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. 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 09Mar2021, the patient experienced all the joints making cracking noises. Pinky finger, knees, ankles, elbows and this was odd, not all the time but the patient cracked a joint almost every hour. This had been for 2 weeks. The patient did not receive any treatment for the adverse event. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event all the joints making cracking noises, pinkie finger, knees, ankles, elbows and this was odd, not all the time but the patient cracked a joint almost every hour was not recovered.   No follow-up attempts are possible; information about lot number cannot be obtained.  Amendment: This follow-up report is being submitted to amend previously reported information: added into Country field under Patient information section. Narrative statement "Since the vaccination, the patient had not been tested positive for COVID-19." updated as "Since the vaccination, the patient had not tested for COVID-19.".
COVID 19 Treatment /Drug ineffective; COVID 19 Treatment / COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), on 20Dec2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 41 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Osteoporosis" (unspecified if ongoing); "Known allergies: Dairy sensitivity" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset Apr2023, outcome "unknown", described as "COVID 19 Treatment / COVID-19"; DRUG INEFFECTIVE (medically significant) with onset Apr2023, outcome "unknown", described as "COVID 19 Treatment /Drug ineffective". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) positive, notes: Treatment of COVID-19; (Apr2023) negative, notes: negative test; (Apr2023) positive, notes: positive test. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 20Apr2023 to 24Apr2023).   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300175804 same reporter/patient, different drug/event;
Had a fever  of 101.2 was nausea  and itching  at site and all over my body I took Tylenol  for the  fever and  and allergy  medicine for the itching.
Right breast implant exploded and spread to her neck where she was having difficulty breathing/Right breast implant erupted. Silicone in breast implant spread into her neck where patient was having difficulty breathing; Right breast implant exploded and spread to her neck where she was having difficulty breathing/Right breast implant erupted. Silicone in breast implant spread into her neck where patient was having difficulty breathing; This is a spontaneous report from a contactable Physician.  A 28-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# unknown), intramuscular on 13Jan2021 10:00 at single dose for covid-19 immunisation. Medical history was none. There were no concomitant medications. Vaccine location was right arm. No prior vaccinations within 4 weeks. Patient called stating she wasn't feeling well. She was in the resident lounge and all of a sudden, the right breast implant just popped. Silicone in her breast implant spread into her neck where patient was having difficulty breathing on 14Jan2021. The patient was hospitalized on 14Jan2021, with pain medication and will have to have the implants removed. They think it is vaccine related. Patient was waiting for general surgery. The outcome of right breast implant exploded was unknown. The outcome of difficulty breathing was not recovered.  Information on the Lot/batch number has been requested.; Sender's Comments: The reported breast implant rupture and associated difficulty breathing were more likely due to breast implant surgery and the quality of implant, and unlikely causally related to the use of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE).  The case will be reassessed should additional information become 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.
Weakness, chills, sweating, nausea, dizziness, headache, restlessness, pain around injection site, joint pain, lower back pain
HEAVY SHOULDER; BURNING IN THE INJECTION SITE; This spontaneous report received from a patient concerned an adult female. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetic. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 25-MAR-2021 for prophylactic vaccination. The batch number was not reported. The company was unable to perform follow up to request batch number. No concomitant medications were reported. On 25-MAR-2021, the subject experienced heavy shoulder. On 25-MAR-2021, the subject experienced burning in the injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the burning in the injection site and heavy shoulder was not reported. This report was non-serious.
Patient called on 9/18/20 to make appointment for 2nd shot. I saw he got 1st shot on 6/20/20 and he was due for the 2nd. As I was navigating his Rx history if he was due for any other shot, I discovered he already received the Shingrix series from 2018 (1st shot 10/2/18 and 2nd shot 12/02/18). I asked him what made him come in for the shot back in 6/20/20, he replied his Dr recommended to get the shot. I asked if he remembers that what he received in 2018, he said he remembers that he got the shingrix and he said he told his doctor on 2018 and 2020 his doctor asked him to get it again. I advised patient not to get the 2nd shot and I said I will inform his primary doctor. I spoke to the office on 9/18/20 and the doctor was informed. On 9/21/20, Md informed to fax his certifcate of immunizations from 2018 and 2020, office manager looked his profile and said in their record it states that patient informed he received the shot on 2018 but they listed it as Zostavax the old shingles vaccine and not the new one. They fixed the record and said they will inform the patient. I myself also informed the patient that his Dr will call him and also convinced we wouldn't need another shot.
Weird transient numbness in his extremities (hand and feet) primarily on his left side; Chest tightness when laying down sometimes; Weird kind of cramp on his left side; Fatigue/fatigue has been kind of lingering/it is over a week now and he's still fatigued; Fever; Chills; Body aches; Headache; Soreness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Weird transient numbness in his extremities (hand and feet) primarily on his left side), CHEST DISCOMFORT (Chest tightness when laying down sometimes), MUSCLE SPASMS (Weird kind of cramp on his left side), FATIGUE (Fatigue/fatigue has been kind of lingering/it is over a week now and he's still fatigued) and PYREXIA (Fever) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 078C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 30-Aug-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Aug-2021, the patient experienced HYPOAESTHESIA (Weird transient numbness in his extremities (hand and feet) primarily on his left side), CHEST DISCOMFORT (Chest tightness when laying down sometimes), MUSCLE SPASMS (Weird kind of cramp on his left side), FATIGUE (Fatigue/fatigue has been kind of lingering/it is over a week now and he's still fatigued), PYREXIA (Fever), CHILLS (Chills), MYALGIA (Body aches), HEADACHE (Headache) and VACCINATION SITE PAIN (Soreness at the injection site). At the time of the report, HYPOAESTHESIA (Weird transient numbness in his extremities (hand and feet) primarily on his left side), CHEST DISCOMFORT (Chest tightness when laying down sometimes), MUSCLE SPASMS (Weird kind of cramp on his left side), PYREXIA (Fever), CHILLS (Chills), MYALGIA (Body aches), HEADACHE (Headache) and VACCINATION SITE PAIN (Soreness at the injection site) outcome was unknown and FATIGUE (Fatigue/fatigue has been kind of lingering/it is over a week now and he's still fatigued) had not resolved.            No concomitant product use was provided by the reporter.   No treatment medications were reported.    This case was linked to MOD-2021-313471 (Patient Link).
The lymph node in the armpit of the arm I received the shot in became significantly swollen. I first noticed this on Saturday 10/2 when I woke up around 7 am.  The size of the lymph node was about the same as a golf ball.  The area was red and very tender.  I have taken Tylenol and/or Advil regularly to help with the discomfort.  I also applied a warm compress to the site.  As of today (10/5/2021), the swelling has reduced, but the tenderness is still present.
Developed rash (itching), big bump on arm at site of injection and redness around 2 inch area, and small blisters; severe pain at arm.
1st dose May 2020, how to proceed with 2nd dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 21-year-old female patient who received HBV (Engerix B) for prophylaxis.   Previously administered products included Engerix B (received 1st dose on an unknown date in May 2020).   On an unknown date, the patient received the 2nd dose of Engerix B. On an unknown date, unknown after receiving Engerix B, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not received 2nd dose, which led to incomplete course of vaccination. The pharmacist enquired how to process with vaccination schedule before administering 2nd dose. The pharmacist did not have lot number or expiration date of 1st dose. The reporter consented to follow up.
This is a spontaneous report from a contactable nurse who reported on behalf of physician. This nurse reported similar events for two patients. This is first of two reports. A 4-month-old male patient received the second dose of PREVNAR 13 (Wyeth, Lot# H08091 and Expiration Date: 02Feb2015) intramuscular in left thigh at 0.5 ml single dose on 09May2014 at 11:00 am. Relevant medical history included reflux since an unknown date in 2014. The patient birth weight was 7-6 Oz and had one sister. The patient received also the first dose of PREVNAR 13 and Rotavirus vaccine on unknown date. The patient previously (within four weeks prior to 09May2014) received the second dose of hepatitis B vaccine (Merck, Batch/Lot#: J007298 Exp date: 2May2016), and the first dose of DTAP-HIB-IPV (Sanofi, Batch/Lot#: C4637AA; Exp date 13Sep2015) both intramuscular on 08Apr2014. Relevant concomitant medication was ZANTAC since an unknown date in Apr2014 (about six weeks) at dose of 1ml two times a day for reflux and the second dose of rotavirus vaccine (Merck manufactured, Lot J008383, exp. date 28Nov2014) oral on 09May2014 at 11:00 am. On 09May2014 the patient was sleeping more than usual. On 10May2014 the patient had high fever, experienced cranky and was not eating. The patient visited the doctor on 10May2014 because of reported adverse events. Relevant laboratory data included complete blood count (CBC) test (unknown results) and negative urine analysis on an unknown date in May2014. Therapeutic measures taken in response to the event high fever included TYLENOL since an unknown date in May2014 at an unknown dose and frequency however the therapeutic measures taken in response to the other reported events were not provided. The patient recovered from fever, irritability and decreased appetite on 11May2014 and from sleeping more than usual on an unknown date in May2014, in 24-48 hrs. The reporter was informed regarding the reported adverse events with the use of the product and confirmed them. The reporter considered there was a reasonable possibility that the events were related to PREVNAR 13. Follow-up attempts completed. No further information expected. Follow-up (02Jul2014): Follow-up attempts completed. No further information expected. Follow-up (14Oct2014): New information from the same contactable nurse who reported on behalf of physician includes: confirmation of the events, administration date modified, route of administration, vaccination history, onset date and recovery dates of the events, causality assessment. Follow-up (07Nov2014): New information received from a contactable Nurse on behalf of physician includes: vaccines manufacturer; birth weight; family history; reporter confirmation of AE occurrence and contactability. Follow-up (13Nov2014): New information reported from a contactable office manager reporting on behalf of a physician includes: new healthcare professional reporter information. Follow-up (09Jan2015): Follow-up attempts completed. No further information expected. Follow-up (19FEB2015): Follow-up attempts completed. No further information expected.
Menstrual cycle was late by 8 day; painful cramps; This is a spontaneous report from a non-contactable consumer, the patient. A 38-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 04May2021 at 13:00 (at the age of 38-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included levothyroxine sodium (UNITHROID) and colecalciferol (VITAMIN D3) all from unknown date, for unspecified indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in the left arm on 13Apr2021 at 13:00 (at the age of 38-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. 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 18May2021 at 07:00 the patient reported that menstrual cycle was late by 8 day, when it did start, it was accompanied by painful cramps, which was not normal for her. She usually did not have cramps with her cycle. The events did not result in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as the result of adverse events and included treatment with MOTRIN. The clinical outcome of the events delayed menstrual cycle and painful cramps were recovering at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
7 patients were given a dose of the Moderna vaccine 26 hours after first puncture; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (7 patients were given a dose of the Moderna vaccine 26 hours after first puncture) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (7 patients were given a dose of the Moderna vaccine 26 hours after first puncture). On 24-Sep-2021, EXPIRED PRODUCT ADMINISTERED (7 patients were given a dose of the Moderna vaccine 26 hours after first puncture) 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 concomitant medication was reported by the reporter. No treatment was reported by the reporter.
I experienced muscle and joint aches, headache and overall malaise.  Approximately 14 days after the first vaccine , started having vision deficits in my left eye out of the blue.  I experienced a fuzziness and haziness in the vision of the left eye and pain above the left eye brow.  Was seen urgently in the eye clinic on 3/29/21 and had a battery of tests - a swollen and inflamed left optic nerve was observed and some deficits to vision and peripheral vision.  Had second vaccine on 3/31/21 and eye seemed to get worse.   Seen by Optical Nerve Specialist on 4/5/21 and had battery of tests and optic nerve worse.  Dr. diagnosed as ischemic optical neuropathy likely due to giant cell artritis (GCA).  I had urgent/emergent temporal artery biopsy on 4/6/21 to determine if giant cell artritis.  Received results from biopsy on 4/13/21 and negative for GCA.  Saw Optical Nerve Specialist on 4/14/21 and diagnosed with ischemic optical neuropathy but cause can not be specified.  Optic nerve is still swollen and vision impacted.  I am to return to clinic in 8 weeks and see if improvement.  I have never had any issue like this in the past.
Rash-neck, face, chest 48 hours after receiving 1st MMR for negative measles/mumps titer.
Following 2nd Moderna vaccine on 3/30/2021, she developed swelling of her gum and tissue under her tongue within an hour of her injection.   Her tongue did not swell.  She and a family member looked in her mouth.  The gums were inflamed, swollen, and painful.    Under her tongue she had raised bumps, some with fluid (blisters) and 2 grey patches.    On 3/31/2021  mouth remained swollen and painful, she was fatigued, and dev fever, chills, headache and muscle aches.   She had a knee that felt inflamed and painful.  She took Tylenol twice.   At the time of this report her gums are somewhat better in some areas, but not in other areas.  She reports difficulty eating due to the discomfort.   Under her tongue remains unchanged.
Within a couple hours of receiving the first vaccine fever in the 102s lasted for multiple days.  Exhaustion and overall flu-like body pains. Arm swelled and was red and itching. Still, two weeks later, swollen and itching with occasional fevers.
Left-sided facial numbness/heaviness, some numbness in left arm.  Patient consulted Dr and was advised that this is caused by her immune response.  Spoke to pt again at 659pm and numbness was improving.  Said she did have a choking/coughing spell due to some numbness in her mouth.
Had a large reaction; Arms are real sore; Fever; Chills; Going to throw up; Diarrhea; This is a spontaneous report from a contactable consumer or other non hcp (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, NDC number, UPC number and Expiry Date are unknown, Lot number: not specified (reported as EW0181 but not sure if the lot number belongs to her or the daughter or the husband)), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. Medical history included Parkinson (not appropriately clarified) from unspecified date. she had COVID on an unspecified date in Jan2021 and she was hospitalized. She was in the hospital for five days. She had strong steroids as treatment. The patient's concomitant medications were not reported. The reporter stated that her husband, herself and her daughter, three of them had out COVID Shot, the Pfizer at (Facility name) and they all three had a large reaction on an unspecified date. She had (incomplete sentence), all 'three' arms are real sore on an unspecified date. When again probed for the concern as call handler was unable to hear the reporter, She stated, she has 'Parkinson' (Not appropriately clarified). She does not understand. She cannot hear good. She further stated that she had COVID back in January and she was hospitalized. She was in the hospital for five days. She had strong steroids as treatment. She was safe for two days (Clarification unknown), after she got the shot, on an unspecified date, she had fever, chills, she was going to throw up and she had a diarrhea and she was due to get it again on 23rd. She asked, does she get it again or does she not?" She added, she talked to the pharmacist. She just wanted to know with the reaction that she had and her daughter, does they take the second shot or does they not? She was scared, she was afraid to 'fell' into the COVID again. She stated, "It's Pfizer. It says, COVID-19 Vaccine, LOT number, it looks like EWC101 or EWC0101 maybe. Pfizer that is the LOT number and it says come back on the 23rd. Are there different LOT number? She was getting a magnifying glass so she can see it. (Later clarified as EW0181)." (Not sure if the LOT number belongs to the consumer or the daughter or the husband). She stated expiration date as 30Aug202 (Further not clarified). She stated she was having a hard time. When again probed for the age and date of birth, she stated, "When I (incomplete sentence), six or couple of days (Clarification unknown). I am scared to get another one, I had (incomplete sentence)." The outcome of events was unknown.  Information about Lot/Batch number is requested
developed acute cerebellar ataxia 8 days after flu vaccine. Normal labs. No imaging done yet since improving.
Maculopapular rash on back with itching. Started 6 hours after vaccination.
This spontaneous report as received from a healthcare worker refers to unspecified patients of unknown gender and unknown age. On an unknown date the unspecified patients were vaccinated with improperly stored ROTATEQ. No adverse events were reported. No product quality complaint (PQC) was reported for ROTATEQ. This is one of the several reports from the same reporter. Additional information has been requested.
Soreness at injection site. Extreme feeling of tiredness. I slept almost the entire day. An over all achy feeling in  my body. I took no medication until the following morning. all pain subsided the next day, April 15.
Patient reports she had contractions and seizure-like activity, as if she had tetanus. She said her hands twisted and locked up. This occurred the day following her vaccine. She  is fine now.