chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report received from a patient concerned a 74 year old female of unknown race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient previously received Covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (dose number in series 1) (suspension for injection, route of admin, batch number and expiry were not reported) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with first dose of Covid-19 vaccine ad26. cov2.s (dose number in series 1). The patient received Covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number: 1855194, and expiry: UNKNOWN) dose was not reported, 1 total administered to right arm on 04-NOV-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-JAN-2022, the patient had a sore throat (dose number in series 2). On 03-JAN-2022, she went to the clinic and underwent polymerase chain reaction (PCR) Covid-19 test, the test came out positive (confirmed Covid-19 infection) which led to confirmed clinical vaccination failure (dose number in series 2). On JAN-2022, she started with a lot of coughing and decreased oxygen, laboratory data included: Oxygen saturation decreased (NR: not provided) decreased, so she returned to the clinic and they did a scan which was negative for clots, and positive for pneumonia (dose number in series 2). On 07-JAN-2022, the patient was administered with steroids and monoclonal antibody. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from Covid-19 pneumonia, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000225106. Sender's Comments: V0: 20220414785-COVID-19 VACCINE AD26.COV2.S-COVID-19 pneumonia. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable. 20220414785-COVID-19 VACCINE AD26.COV2.S- Confirmed clinical vaccination failure. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Patient had a reaction to ZOSTAVAX vaccine. An orange size rash. The rash itches and has pain equivalent to a bee sting. It is swollen.
Red, swollen, burning sensation, the size of big Rolex watch. Not itching or painful. Pt feels a little dizzy. Pt is still feeling of burning sensation today (8/3/11 at 8:15pm). Advised pt to take BENADRYL and if symptoms worsen to call the pharmacy or her doctor.
Terrible rash on her whole body, and it itches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) from medical information team. The reporter is the patient. A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for Covid-19 immunization. The following information was reported: RASH PRURITIC (non-serious), outcome "unknown", described as "Terrible rash on her whole body, and it itches".  Additional information: The patient states that she is calling about the Pfizer Product Covid Vaccine. The patient states that she got her booster shot on Monday afternoon and by Tuesday she had a terrible rash on her whole body, and it itches. The patient asks what she can do to get this to disappear. The patient would like to know how many people have experienced a rash similar to hers. The patient would like to know if there was anything Pfizer suggests or recommend in order to make this rash go away.  The information on the batch/lot number for [BNT162B2, BNT162B2 OMI BA.4-5] has been requested and will be submitted if and when received.
Severe muscle and joint pain for 2 days, swelling in the injection site 2 days and lack of appetite.
12/09/2008 Mother of child presents with sibling of patient. Reports that approximately 24 hours after patient's immunizations on 03/37/2008, she was "drowsy all day.  Woke up the next morning on 03/29/2008 hands were shakey, demonstrated an unsteady gait"  Child taken to ER.  Child kept for three days, given IV therapy, several tests were run on child per mom, which all had negative results.  States ER physician concluded since all test results negative, S&S must have been reactions to immunizations.  Mom states she will get recommendations from PMD for future immunizations.  12/10/2008 MR received for DOS 3/31-4/02/2008 with D/C DX: Acute onset of weakness.  Possible injestion of medication vs post-viral cerebellitis. Pt presented with onset of generalized weakness, difficulty walking and feeding self. Concern child may have accidently injested family member's meds but pill count did not show any missing. PE (+) for hypotonia. Improved with IVF. To be f/u as outpt.
mom states afternoon following last vax pt felt warm going down for nap; pt was given APAP; temp inc to 105; mom called MD & cont APAP x 48 hrs; pt crabby & slowed down;
HIVES, tachypnea, vomiting - normal saline, neb tx, solumedrol, Benadryl, epi
2-1 to 2-4 absent from school for - Flu / mom. Referred 2/8 2 PM for lethargy, difficulty walking & talking. Afebrile. VSS.
telephone call from MD stating pt had t105; no other sx twin recvd same immun was OK; MD felt fever was due only from DTAP vax;
Eosinophilia in blood, accompanied by sporadic mild-to-moderate myalgia of skeletal muscles (e.g.,  aches, pain, tenderness, stiffness).  Dose 1 of SHINGRIX was administered on 02/01/2019, followed by Dose 2 on 04/30/2019.  Both doses caused substantial injection site myalgia for about 3 days as well as general malaise, which are typical adverse events from SHINGRIX.  However, over months after Dose 1, sporadic pain, etc. in muscles or possibly tendons, particularly in the abdomen, back and right hand was experienced.  [See Continuation Page Below]  Although the myalgia was initially attributed to dancing and yard work activity, which may have been contributing causes, their slow resolution was considered unusual,by the patient, suggesting continuing inflammation instead of healing.  The adverse symptoms continued after Dose 2.  A blood test on 05/23/2019 (i.e. 23 days after Dose 2) showed 725 eosinophils / uL, indicative of Eosinophilia.  No doubt the Eosinophilia began well before the 05/23/2019 blood test, likely after Dose 1.   Eosinophilia is well known to potentially promote inflammation, thus causing or exacerbating observed symptoms.  The patient has no prior history of Eosinophilia; a test on 05/15/2018 measured 270 eosinophils  / uL.  As of 06/05/2019, the adverse muscular symptomology appears to be gradually resolving.  A quick literature search did not find previous disclosure of SHINGRIX causing Eosinophilia, but found that Quillaja saponin component QH-A (which includes SHINGRIX's adjuvant) both alone and in combination with a viral antigen markedly increases expression of the cytokine interleukin 5 (IL-5), which is well known to promote the production of eosinophils.  As a probably not relevant side note:  The patient was determined to be homozygous with the CCR5 delta 32 mutation.
This spontaneous report as received from a pharmacist refers to a patient of unknown age with prophylaxis. On 23-AUG-2017 the patient was vaccinated with M-M-R II lot # L029266 for prophylaxis. Concomitant therapies included sterile diluent (STERILE DILUENT). On 23-AUG-2017, the patient experienced expired product administered. No adverse effects reported. The outcome of expired product administered and no adverse event is unknown.  The reporter considered expired product administered and no adverse event to be not related to M-M-R II.
Immediately after vaccines administered, mom pick child up and was holding her in her arms. Mom and child still in treatment room. Heard mom cry out for help and handed child to corpsman. Entered room to find child unresponsive and limp. Mild circumoro cyanosis. Stiffened extremities briefly then relaxed. Unresponsive for about 20 seconds. Breathing and strong heart rate palpated. Able to talk to RN about recent birthday and the cake she ate. Skin color pale and is crying looking for her mother. Mother at bedside talking to her and reassuring her. Discussed with child's PCM who will see in pediatrics. Walked with child and mother to pediatric clinic.
Severe bilateral tinnitus; Hearing loss; This is a spontaneous report from a contactable nurse reporting for self. A 38-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, administered in left arm  on 19Jan2021 (at the age of 38-years old) (Batch/Lot Number: EL1293) as a single dose for COVID-19 immunization. The patient had not received any other vaccines in the 4 weeks prior.  Medical history included postural orthostatic tachycardia syndrome (POTS) from an unknown date. The patient had not experienced COVID prior to vaccination. The patient's concomitant medications were not reported.  The patient previously received first dose of BNT 162b2 on 29Dec2020 at 12:00 PM, in left arm for COVID-19 immunization; and previously received CECLOR and experienced allergy.  The patient developed severe bilateral tinnitus and hearing loss on 04Feb2021 at 2:00am, 2 weeks after vaccination with 2nd dose. The event resulted in a doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care visit, and Disability or permanent damage. As treatment for the events, the nurse reported "multiple visits to doctors and medications hearing." The outcome of the events severe bilateral tinnitus and hearing loss were not recovered. The patient wasnot COVID-tested post vaccination.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine can not be excluded for the reported events of tinnitus and hearing loss due to temporal relationship.  Case will be re-assessed upon the additional information provided. 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.
no adverse reaction until 7 days after vaccination. 01/28/2021 stiff muscles and joints , extreme fatigue, loss of appitite, fever of 99  or higher continuing  into its 6th day
Admitted 9/2 due to fatigue, fevers, shortness of breath and near syncope.  Tested positive for COVID-19 08/25/2021.  Received monoclonal antibody therapy following.  Patient is vaccinated for COVID-19.
This spontaneous report was received from a physician concerning an approximately 25 year old female patient with type 1 diabetes, asthma, rosacea, lactose and gluten intolerance and unspecified reaction to unknown vaccines. The medical history of the patient included eczema. On 08-DEC-2011, the patient was vaccinated with dose 1 of PNEUMOVAX23 (lot number, expiry date, dose and route unspecified) with no adverse events. On 23-MAR-2013, the patient was vaccinated with dose 2 of PNEUMOVAX 23 (lot number and expiry date reported as H018608 and 02-JUL-2014 respectively, dose and route unspecified). No concomitant medications were reported. On an unknown date, approximately in March 2013 (reported as recently), the patient was diagnosed with cellulitis at the injection site and was admitted to the hospital. The patient sought medical attention (hospitalized). Name of the hospital was unknown. Before hospitalization, the patient was advised to use heat on the injection site reaction and to take over the counter pain medication as a treatment. The patient had not recovered from cellulitis at the injection site at the time of reporting. The relatedness for the event was unknown for PNEUMOVAX23. Additional information has been requested.
On  04/01/2021,  at 3:00 pm, experienced severe stomach pains; joint pains; muscle aches; headache; back pains; tingling of tongue and mouth; swollen eyes and face; chills.
Tested positive for COVID-19; Tested positive for COVID-19; Congestion; Aches; Coughing; Fatigue; lost her sense of taste; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP).  A female patient received BNT162b2 (BNT162B2), on 27Feb2021 as dose 1, single (Batch/Lot number: unknown), on 20Mar2021 as dose 2, single (Batch/Lot number: unknown) and on 26Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Tested positive for COVID-19"; SINUS CONGESTION (non-serious), outcome "unknown", described as "Congestion"; PAIN (non-serious), outcome "unknown", described as "Aches"; COUGH (non-serious), outcome "unknown", described as "Coughing"; FATIGUE (non-serious), outcome "unknown"; AGEUSIA (non-serious), outcome "unknown", described as "lost her sense of taste". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Tested positive for COVID-19.  Clinical Information: Reporter stated he learned 24Apr2022 that his friend, F50, tested positive for COVID-19. The patient symptoms included congestion, fatigue, aches, coughing. She had received the Pfizer vaccine and booster (27Feb2021, 20Mar2021 and 26Oct2021).  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Two weeks after I got the shot I got the following symptoms. Not sure if they are related or not to the vaccine. - left arm tingling - belly tingling - headache (persistent but mild) - diarrhea - felt like I was about to faint when walking
Pharmacist inserted the needle into the patient's arm.  As she pressed down on the plunger, the needle detached from the syringe and part of the dose spilled onto the patient's arm.  It's unclear how much of the dose was administered, as the syringe was empty.  After discussing it with the patient, pharmacist and pt agreed to administer another dose to ensure he received the full dose.
Circumstance or information capable of leading to medication error; Inappropriate age at vaccine administration; This case was reported by a physician via call center representative and described the occurrence of circumstance or information capable of leading to medication error in a 29-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced circumstance or information capable of leading to medication error and inappropriate age at vaccine administration. On an unknown date, the outcome of the circumstance or information capable of leading to medication error and inappropriate age at vaccine administration were unknown.  Additional details were provided as follows: The age at the vaccination was not applicable for this report. The vaccine has not been administered at the time of this report. A doctor reported that a 29 year old male with a history of Shingles may get Shingrix, and if administered might lead to circumstance or information capable of leading to medication error and inappropriate age at vaccine administration. This was a potential medication error.
Swelling has moved to under arm area. noticed underarm swelling on 28Nov2021; Booster; Severe swelling at injection site.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49 year-old female patient (not pregnant) received bnt162b2 (BNT162B2, solution for injection), administered in arm left, administration date 26Nov2021 (Lot number: FG3527) at the age of 49 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0179, Location of injection: Arm Left), when the patient was 49 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Er8737), when the patient was 49 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 26Nov2021, outcome "unknown", described as "Booster "; VACCINATION SITE SWELLING (non-serious) with onset 26Nov2021, outcome "unknown", described as "Severe swelling at injection site."; LYMPHADENOPATHY (non-serious) with onset 28Nov2021, outcome "unknown", described as "Swelling has moved to under arm area. noticed underarm swelling on 28Nov2021". Therapeutic measures were not taken as a result of immunisation, vaccination site swelling, lymphadenopathy  Additional information: Events were non-serious as per the reporter. Prior to vaccination, patient was not diagnosed with COVID-19 and Since the vaccination, patient had not been tested for COVID-19. Device Date : 29Nov2021 . No follow-up attempts are possible. No further information is expected.
Bad infection: Initial information was received on 07-Nov-2021 regarding an unsolicited valid non-serious case received from social media from (under reference number - US-SA-SAC20211111000510) Regulatory Authority.  This case involves adult patient (unknown gender) who was experienced bad infection (infection), after receiving vaccine INFLUENZA VACCINE.  The patient's medical history, past medical treatment(s), concomitant therapy, concomitant medication(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious bad infection (infection) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "Got one last year antibiotics for seven days bad infection."  It is unknown if the patient experienced any additional symptoms/events.  It is unknown if there were lab data/results available.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was unknown for the event.  There will be no information available on batch number for this case.
diarrhea; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), PYREXIA (Fever) and CHILLS (Chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (diarrhea), PYREXIA (Fever) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, DIARRHOEA (diarrhea), PYREXIA (Fever) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication details were not reported by the reporter.
Mother called PM of 10/26/2017 to report that child's arm where he received his flu vaccine on 10/24/2017, was red and had a "knot the size of baseball" around injection site. She states that he has had no fever and the site is not draining. She first noticed the problem the morning of 10/25/2017 and marked the site to monitor size. Mother stated that she noted no significant change PM of 10/24/2017 and gave child BENADRYL. She was advised to call to report this to us by a relative who is a paramedic. I explained that this reaction is a possible side effect of any vaccine and that careful monitoring, as she has done, is important. She reported that the site had reduced slightly the
Generalized body aches, chills, diaphoresis, fatigue, mild headache, pain in chest with deep breathing and SOB.
I was having a sore throat not even sore more irritated, and I was clearing it a lot. The next day I lost my voice and later into the evening I was having body aches and had a fever of 100.5. I was having a lot of pressure in my head, and it was throwing off my equilibrium and I was getting dizzy. I was having this clear sticky snot but no runny nose. I had tested for COVID-19 on the first day and it was negative but the second day, I was positive. I have been having this inflammation in my head and I have followed up with an ENT with this issue as it is still a problem. The body aches and fatigues were really bad. I was testing positive 14 days later and on day 23 as well.  Day 32 is the first day I have felt almost normal but with allergies coming up I am having intense pressure in my ears and my head, but I am improving.
patient felt cold and shaking. she did Not have a fever. she went to hospital and they ran labs and everything was fine. they gave her IV but it is unknown if medicine in IV.  she was at hospital for 4 hours
Patient received Bivalent vaccine for 12years+ when the patient was 11 years and 8 months old. No adverse events reported.
Headache body ache fever 100.0 tired.  Lasted 24 hours.
Headache, NauseaVomiting,  swollen and painful left axilla and left arm; chills, strange taste in mouth  Narrative:  1/5 received vaccine. 1/6 woke up with left arm/axilla swollen and  painful, severe headache, nausea, and chills. Also has a strange taste in his mouth.  He stayed home from work. 1/7 employee reports fever overnight, chills, and lump  under his left arm has enlarged. Advised to see his PCP. 1/8 left axillary lump has  decreased from softball size to baseball size. It's still tender. His arm pain has  improved. Headache, nausea, and chills have resolved.
Approximately 9 1/2 hours after flu vaccine was administered, weakness and shaking showed up in both legs.  During the evening until I went to bed, the weakness was such that I was unsure of be stable enough to walk without a lot of concentration on the effort so that I would not fall.
Mild headache, mild fatigue, mild malaise, moderate deltoid pain and swelling at injection site for 24 hours.
SHE REPORT PAIN AND NUMBNESS ON BOTH ARMS, ITCHY SPOTS AND BLISTERS ON BOTH ARMS. SHE REPORT SYMPTOMS BEGAN TWO WEEKS AFTER ADMINISTRATION OF VACCINES
still in pain from joints and muscles; still in pain from joints and muscles; This is a spontaneous report from a contactable consumer (patient).  A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6205), via an unspecified route of administration on 25Feb2021 as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient reported that he/she had the shot on 25Feb2021 and he/she was still in pain from joints and muscles which started on an unspecified date. Outcome of pain from joints and muscles was unknown.    No follow-up attempts are possible; information about lot/batch number cannot been obtained.