chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sore left Arm; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old male patient 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 04Aug2021 at 12:15 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma, eczema and allergic to fish, grass and oak pollen. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included loratadine (CLARITIN) and salbutamol (ALBUTEROL INHALER); both for an unknown indication from an unknown date. On 04Aug2021 at 12:15, the patient experienced sore left arm. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had been tested for COVID-19. On an unknown date, the patient gave nasal swab for SARS-CoV-2 test and the result was negative. The clinical outcome of the event sore left arm was recovering at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
J96.02 ACUTE HYPERCAPNIC RESPIRATORY FAILURE 3/14/2023 LEUKOCYTOSIS J96.10 CHRONIC RESPIRATORY FAILURE 5/30/2023 LEUKOCYTOSIS J96.11 CHRONIC HYPOXEMIC RESPIRATORY FAILURE 5/26/2023 LEUKOCYTOSIS J96.21 ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 5/26/2023 LEUKOCYTOSIS
She has noted redness and swelling to there left arm, surrounding the injection site. Denies pain, but does note itching.  There is mild erythema to the posterior deltoid region, no pain or tenderness to palpation.  No vesicles noted.
Patient reported to school nurse 4/1/11. Started swelling late at night on night of vaccination. Sore to touch. Measured site for range of swelling. Measured 3" x 3" across 3 x 2.5 length.
After 2nd does an hour later I felt dizzy while driving, flu symptoms occured about less then 2 hours after my shot, ( pressure in chest causing trouble breathing  & lymph nodes swollen; these 2 symptoms we're not as severe when I had my 1st shot),  migraines daily now, and lastly I bleed again but this caused my cycle to reoccur 2 weeks early very unusual pain.
Breakthrough case: I was exposed to Covid-19 on 08/08/2021 at a birthday party. I developed symptoms around 08/20/2021. I tested positive for Covid-19 on 08/23/2021.  My symptoms included congestion, runny nose, cough, headache, and tiredness. I had a fever for a few days.
C/o fine red rash w/itching 2FEB, worsened 3FEB; malaise, headache, diarrhea, no fever, scratchy throat dry hacking cough; Lt knee swollen; 4FEB difficulty in walking, taking Tylenol & Benadryl for discomfort.
The pt was seen in the ER on 11/7/00 at 11:32am, complaining of left arm pain, tingling and numbness. Treated with Advil/Motrin.
I had unexpected menstrual bleeding for 17 days after the shot. I saw a doctor at my doctor's office and she ordered lab work that I haven't done yet but will be doing soon.
Born during Covid have not spoken a word at this time/ the only word they say is "da-da"; This spontaneous case was reported by a consumer and describes the occurrence of SPEECH DISORDER DEVELOPMENTAL (Born during Covid have not spoken a word at this time/ the only word they say is "da-da") in an infant male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) for COVID-19 prophylaxis.    The patient's past medical history included Exposure via semen and Maternal exposure during pregnancy.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Transplacental) 1 dosage form and first dose of COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) (Transplacental) 1 dosage form. On an unknown date, the patient experienced SPEECH DISORDER DEVELOPMENTAL (Born during Covid have not spoken a word at this time/ the only word they say is "da-da"). At the time of the report, SPEECH DISORDER DEVELOPMENTAL (Born during Covid have not spoken a word at this time/ the only word they say is "da-da") outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Transplacental), the reporter did not provide any causality assessments.   This case was considered for the second grandson.  No concomitant and treatment medications were reported.  Caller finds it odd that both of the grandsons who were born during Covid have not spoken a word at this time, the only word they hear is "da-da".  Caller stated that they were unsure if the grandsons were given Moderna Covid-19 vaccines already. Caller stated that this could also be natural but they wanted to know if there's been research regarding the possibility of this condition being caused by the vaccine.   This case was linked to US-MODERNATX, INC.-MOD-2023-722093 (E2B Linked Report). This case was linked to MOD-2023-722091, MOD-2023-722091 (Parent-Child Link).   See case MOD-2023-722091,MOD-2023-722091 for details regarding the child case.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-722093:Case for Mother of 2nd grandson
Was given the H1N1 Vaccine on 11/13/09. Child started complaining of tingling in left leg the following evening. When he woke on Sunday 11/15/09 he complained of weakness and tingling of both legs. Presented to our office on Monday 11/16/09 and we contacted neurology immediately for a consult. Was seen by neurologist the next morning. Neurologist did feel as though this was a vaccine reaction and would follow the child and watch for any progression. Child said the tingling and weakness began to disappear as the week went on. Mom states he is not complaining any longer and no further problems have occurred. Advised to keep follow up appointment with neurologist and call our office if there are any changes.
Itchy arm at injection time1230 10/22/21, subsided after 5 mins. Headache and eye pain 10/22/21 1400. Injection site became swollen at 1800 10/22/21. Bad headache 2100 10/22/21, fell asleep around 2200.  Woke at 0300 10/23/21 with bad stomach pain. 0400, terrible sweats, nausea, and diarrhea.  Terrible sweats and stomach pain through 0630 10/23/21.  Woke at 0900 10/23/21, with horrible headache, neck ache, swollen injection site and arm pain. Stayed in bed for the remained of 10/23/21. Tired and weak, for both days fever never broke 100 degrees. 10/24/21, still very weak, severe headache and body aches. Swelling of injection site has gone away, arm still sore.  10/25/21, still felt very weak and uneasy, severe headache, body feels like it?s on fire, but no fever and body ache. Went to ER 10/25/21 at 2100, given IV fluids and pain meds, told to rest and take it easy. 10/26/21 - 10/28/21, headache, no fever, sweats,  feel very weak. 10/29/21, a injection site, is itchy and sore. 10/30/21, injection site is very swollen and itchy headache is back, have been dizzy and faint all day. Sounds are very amplified and annoying.  10/31/21, headache, sweats are back.
This spontaneous report as received from a pharmacist refers to a patient of unknown age. The patient was vaccinated with improperly stored PNEUMOVAX 23 on 21-AUG-2012. Lot# was reported as 0217AE, expiration date: 22-AUG-2013. Route was unspecified. No adverse events reported. The vaccine storage information was reported as "From 04-AUG-2012 to 09-AUG-2012, lowest temp excursion exposed to -1.7C for 65 minutes and exposed to 0C to 2C for total of 80 minutes. High temp excursion exposed to 11.1C for 322 minutes (5.4 hrs). From 12-AUG-2012 to 14-AUG-2012, lowest temp excursions at -1.9C for 153 minutes, -0.5C for 90 minutes, 30 minutes and 60 minutes and exposed to 0C to 2C for total time of 407 minutes. From 14-AUG-2012 to 28-AUG-2012, lowest temp excursions at -8.3C for total of 9 hours (2 excursions), -3.6C for total of 19 hours (2 excursions), -4.8C for total of 12 hours (4 excursions) and -5.7C for total of 9.5 hours (2 excursions). High temp excursion exposed to 18.4C for 1 hour and 10 minutes." This is one of several reported received from same source. 1209USA007525, 1209USA008597, 1209USA008598, 1209USA008599, 1209USA008601, 1209USA008602, 1209USA008603, 1209USA008604, 1209USA008605, 1209USA008606, 1209USA008607, 1209USA008608, 1209USA008609, 1209USA008610, 1209USA008611, 1209USA008612, 1209USA008613, 1209USA008614. Additional information has been requested.
3 week duration: Parasthesia, chest pain, leg pain, nerve pain, headache, buzzing sensation,  extreme burning pain in chest, random days of heart rate of 110, extreme fatigue resulting in loss of work.  5 week duration: Severe random nausea, trouble eating  6 week duration and continues: Tinnitus (never had this in my life), trouble hearing high frequencies. This entire vaccine experience has been the most awful health issue I have ever encountered. Will not get 2nd dose. People don't know to report otherwise you would know tinnitus is definitely a problem.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old male patient received BNT162b2 (BNT162B2), on 16Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 57 years for COVID-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3, single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, COVID-19 and included Paxlovid. Clinical course: Anti-viral details: COVID 19 Treatment (Paxlovid) was started from 02Aug2022 and stopped on 06Aug2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
I have a sore on my tongue; administration date=01Oct2021,dose number=2;rev dose administration date=27Jul2021,dose number=1; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 01Oct2021 15:30 (Lot number: FE3592) at the age of 46 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Allergy: shellfish" (unspecified if ongoing), notes: known allergies: shellfish; "Allergy:milk" (unspecified if ongoing), notes: known allergies: milk; "alcohol" (unspecified if ongoing), notes: known allergies: alcohol. Concomitant medication(s) included: VITAMIN C [ASCORBIC ACID]. Past drug history included: Hydrocodone, reaction(s): "Allergy:hydrocodone", notes: known allergies: hydrocodone; Tramadol, reaction(s): "Allergy: tramadol", notes: known allergies: tramadol; Oxycodone, reaction(s): "Allergy: oxycodone", notes: known allergies: oxycodone. Vaccination history included: Bnt162b2 (Prev dose product=COVID 19,, Prev dose brand=Pfizer,Dose Number: 1, Batch/Lot No: EW0191, Location of injection: Arm Right), administration date: 27Jul2021, when the patient was 46 years old, for COVID-19 Immunization. The following information was reported: GLOSSODYNIA (non-serious) with onset 01Oct2021 19:30, outcome "not recovered", described as "I have a sore on my tongue"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 01Oct2021 15:30, outcome "unknown", described as "administration date=01Oct2021,dose number=2;rev dose administration date=27Jul2021,dose number=1". Therapeutic measures were not taken as a result of glossodynia.  Additional information: The patient had a sore on tongue that cannot be described by any other thing. It began as a very tiny sore several hours after the vaccine and had gotten larger through the night last night and through today. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19.  Follow-up attempts are completed. No further information is expected.
Patient was inadvertently given Tdap when Dtap was ordered along with MMR, Varicella, and IPV as part of child's 4-6 year old booster vaccinations. Mother of child was immediately made aware  error with instructions to bring in if any adverse reactions were noted. Child was re-evaluated by myself PA-C on 8-16-2018 with an 7.0 cm X 5.5 cm erythematous and mildly edematous and left anterior thigh where the Tdap was given 48 hours prior. I recommended Cetirizine 5mg/mL 2.5mL-5mL PO Q/day along with Hydrocortisone 2.5% cream applied BID until resolved with introductions to use no longer and 7 days. Child was recommended for follow up visit on 8-2018 or to the emergency room if symptoms worsen. Patient's PCP Dr. and our office manager were made aware of event.
Little soreness in her arm; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received bnt162b2 (lot number and expiry date were unknown), via an unspecified route of administration on unspecified date in Dec2020 at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter got the COVID vaccine yesterday, maybe, caller is not exactly sure, now states she thinks it was Tuesday or Wednesday, but caller is not sure. She has a little soreness in her arm on an unspecified date. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
redness is increased to 3 inch x 5 inch; Rash area is increased; arm is now very tender; Arm very sore; redness at the injecton site; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of ERYTHEMA (redness is increased to 3 inch x 5 inch), VACCINATION SITE PAIN (Arm very sore), TENDERNESS (arm is now very tender), VACCINATION SITE RASH (Rash area is increased) and VACCINATION SITE ERYTHEMA (redness at the injecton site) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN), CLOPIDOGREL BISULFATE (PLAVIX), VALSARTAN, ATORVASTATIN CALCIUM (LIPITOR), LANSOPRAZOLE (PREVACID), PARACETAMOL (TYLENOL) and IBUPROFEN for an unknown indication.    On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (redness at the injecton site). On 01-Mar-2021, the patient experienced VACCINATION SITE PAIN (Arm very sore). On 02-Mar-2021, the patient experienced TENDERNESS (arm is now very tender). On 03-Mar-2021, the patient experienced ERYTHEMA (redness is increased to 3 inch x 5 inch) and VACCINATION SITE RASH (Rash area is increased). At the time of the report, ERYTHEMA (redness is increased to 3 inch x 5 inch), VACCINATION SITE PAIN (Arm very sore), TENDERNESS (arm is now very tender), VACCINATION SITE RASH (Rash area is increased) and VACCINATION SITE ERYTHEMA (redness at the injecton site) outcome was unknown.        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.
A dose of moderna bivalent of 0.25 ml was administered, when the correct dose is  0.5 ml..
fell; Breathing issues; Heart palpitations; Pressure in the heart; Vision is blurry; Problems with sweating; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DYSPNOEA (Breathing issues), PALPITATIONS (Heart palpitations), CARDIAC DISCOMFORT (Pressure in the heart), VISION BLURRED (Vision is blurry) and HYPERHIDROSIS (Problems with sweating) in an 89-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history.).    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Mar-2021, the patient experienced DYSPNOEA (Breathing issues), PALPITATIONS (Heart palpitations), CARDIAC DISCOMFORT (Pressure in the heart), VISION BLURRED (Vision is blurry) and HYPERHIDROSIS (Problems with sweating). On an unknown date, the patient experienced FALL (fell). At the time of the report, DYSPNOEA (Breathing issues), PALPITATIONS (Heart palpitations), CARDIAC DISCOMFORT (Pressure in the heart), VISION BLURRED (Vision is blurry), HYPERHIDROSIS (Problems with sweating) and FALL (fell) outcome was unknown.        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.   This case was linked to MOD-2021-073917 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 16-May-2021: NNI-non significant email response about FU
LOW IRON; MUSCLE ACHES; This solicited report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included crohns disease, and other pre-existing medical conditions included unknown. The patient received combination product ustekinumab (solution for injection in pre-filled syringe, subcutaneous, batch number: UNKNOWN expiry: UNKNOWN) dose was not reported, 1 time every 4 weeks, from 22-MAR-2021 for crohns disease. Product constituent parts included . The patient initiated treatment with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN expiry: UNKNOWN) dose was not reported, administered on MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the patient experienced low iron. On MAR-2021, the patient experienced muscle aches. Treatment medications (dates unspecified) included: iron. The action taken with covid-19 vaccine ad26.cov2.s, and ustekinumab was not applicable. The outcome of the muscle aches and low iron was not reported. The reporter considered the causality between covid-19 vaccine ad26.cov2.s, and low iron, and muscle aches as possible; and between ustekinumab, and low iron, and muscle aches as possible.  This report was non-serious.
Narrative:  Hospitalization, COVID positive and fully vaccinated upon admission, admitted for productive cough and urinary frequency
Red round raised area where DtaP was given on right thigh, started evening of 08-08-2006, went to emergency room, ice and BENADRYL ordered.  Came back to office 08-10-2006, almost entire right thigh had red raised welt.  Doctor advised continue ice and BENADRYL.  Doctor spoke with family member 0-13-2006 better.  Also spoke with sister 08-14-2006 almost gone.
ringing in her ears; aphasia; sever fatigue; headaches; A Spontaneous report was received from the nurse  concerning 51 year old female patient who received the second dose of moderna's COVID-19 vaccine(mRNA -1273) and experienced aphasia, sever fatigue, headaches and buzzing/ringing in her ears.  The patient medical history  and concomitant medications were not provided.  On 03-FEB-2021, prior to onset of events the patient received two doses of mRNA (Batch no: 004M220A)vaccine for prophylaxis of COVID-19 infection.  After receiving the second dose,  she had neurological symptoms. She has buzzing or ringing in her ears  and aphasia, severe fatigue. She cannot work for more than 4 hours and she had continous headaches. The ringing gets worse when she gets tired.  Two neurologist have put the patient on concision protocol for two weeks  Action taken with mRNA response to the events was not reported.  The outcome of the events was considered unknown.; Reporter's Comments: Based on the current available information and a strong temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.  Fatigue and headache are consistent with the product known safety profile.
Moderna Lot Number 045J21A was inadvertently used one day beyond the expiration date of May 2, 2022.  Per FDA (Food and Drug Administration) guidance, Moderna was contacted on May 3, 2022 about the vaccine storage error.  Moderna conducted research on the same lot number and simulated the same conditions noted by local Public Health.  Moderna found that the vaccine met the required activity to produce the needed immune response.  This is Moderna Case Number CEA-2351.  Although Moderna noted this vaccine was sufficient to produce the needed immune response, patient was encouraged to speak with their provider to determine the next steps appropriate for them.  Patient has experienced no known adverse events.
Admitted for COVID pneumonia. Fully vaccinated in June. Treated with steroids, zinc, vit-c, O2, remdesivir, rocephin. Required HFNC but eventually weaned to 1 L and discharged home with O2.
Neurological symptoms including autonomic dysfunction with difficulty regulating temperature and elevated HR followed by nerve pain into hands and feet, extreme joint pain, headache and spine pain, and then numbness of the hands and lips. Began about 10 hours post vaccine and subsided except headache and joint pain within 16 hours
R thigh at imm site 1" red, warm lump. Mild swelling No streaking. No fever.
At 2:30 in the morning I woke up to go to the bathroom.  On the way back to bed I fell.  My husband hear me fall and came out.  I was unconscious.  When he tried to get me to our room, I had a seizure.  He called 911   This was all a matter of 2 minutes total. I  have never had one before.   I am in good health.    My BP was 92/ 65 when paramedics arrived.   It is normally 110/ish/60ish.   Paramedics thought perhaps I was dehydrated.
I received the vaccine at 12:30 PM on 4/9/21 and began feeling ill around 8:00 PM that same day. It started with my body freezing and then I started shaking because I felt so cold and I covered up in blankets and a heating pad and still felt extremely cold. Then, the body aches began, and my whole body was very tired. After an hour of sleep, I took my temperature and it was 100.8. That is the highest that it rose to. My normal body temperature is 97.4. This lasted all through the night up until Saturday afternoon around 3:30 PM on 4/10/21.
pt recvd vax 315PM sl facial & chest pruritis noted 350PM; MD notified pt brought to clinic given epi & DPH;pt now sl SOB-clearing throat;
Intrauterine fetal demise diagnosed on 10/29/09. Last FM felt on 10/28/09. Not clear if this is related to vaccination.  Medical records received for DOS 7/09/09-11/04/09. Neg fetal movement and HT in office, Fetal demise 32 weeks. Approx 2 wks s/p vaccine. LMP 02/02/09.  EDD 11/08/09.   Prenatal care late. (+) THC use.  (+) urine E coli. (+) alcohol use. (+) Chlamydia.     11/09/09 Medical records received. Duplicate of records from 11/06/09
From 03/22, 6 PM - 3/24, 4 AM, this infant has had a fever of 102 - 104. On 03/23, she had a slight rash (small red dots) on her face that spread to her back and her stomach. On 03/24, you could see white rings around the red dots. The patient visited the doctor on 03/24 at 4 PM. The doctor indicated that it could be varicella. On 03/25 , the rash spread slightly to diaper area, and 1 or 2 on her legs. On 03/26, the rash was gone from her lower body. On 03/27, the rash was gone from her face.