chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received vaccine and was observed for 15 minutes, she then returned abour 20 minutes after that to the clinic w shortness of breath, difficulty breathing and complaining of her throat swelling.  She was given one injection from and EPi-pen, 911 was called and she was transported to the Hospital. Per hospital records she received benadryl, famotidine and solumedrol and was discharged from the ED.
Pneumococcal 23 administered 2/28/17. Pt phoned 3-2-17 to report an injection reaction. Pt C/O soreness at injection site, localized redness, erythema and swelling to the bicep and tricep.
tachycardia; This is a spontaneous report from a contactable nurse via medical information team. A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via unknown route of administration on unspecified date as dose number unknown single for COVID-19 immunization. Medical history and Concomitant medications were not reported. Reporter was a nurse who was calling looking for information regarding side effect of tachycardia after wife received the Pfizer Covid vaccine. The outcome of event was unknown.  Information on the lot/batch number has been requested
Fever 102-103 with fever reducing meds  Severe Headache , chills, lethargy and pain in hips Skin/touch painful All symptoms started at 6pm 1/28 till now 11:39am  Fever down to 101 as of 9:30am with fever reducing meds/ Ibuprofen 800mg taken at 5am
has auto immune disorder; This is a spontaneous report from a Pfizer-sponsored program received from a non-contactable consumer (patient). A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot/batch number not reported, via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported.  It was reported that patient had first vaccine shot, has auto immune disorder "prethzone" (as reported) then scheduled for 2nd shot this Sunday, and has spoken to HCP.  The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Reaction to DAPTACEL - Redness 103.2 cm X 10 cm. Started 4/030/10 - and progressively worsened. Warmth to touch slightly.
Awoke with chills, rapid pulse, fever of 102F.  Complaining of neck and ear pain.
Interchange of vaccine products; COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 70-year-old male patient received bnt162b2 (BNT162B2), in Apr2021 as dose 1, single (Batch/Lot number: unknown), in left arm and in May2021 as dose 2, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), in Jan2022 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "addison's" (unspecified if ongoing); "sulfa-trimethoprim" (unspecified if ongoing); "chronic HSV" (unspecified if ongoing); "hypgonadal hypoT" (unspecified if ongoing). Concomitant medication(s) included: HYDROCORTISONE oral, start date: 01Jan2008, stop date: 26Oct2023; FLUDROCORTISONE oral, start date: 2008, stop date: 26Oct2023; TESTOSTERONE topical, start date: 2008, stop date: 26Oct2023; ACYCLOVIR [ACICLOVIR] oral, start date: 2000, stop date: 26Oct2023. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Treatment included Paxlovid from 15Oct2023 to 19Oct2023.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on available information, a lack of efficacy under interchange of vaccine products with the suspect vaccine BNT162B2 in this patient cannot be completely excluded.
STROKE; This spontaneous report received from a patient via a company representative concerned a male of unspecified age, 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 his initial vaccination (series 1) with Janssen covid-19 vaccine ad26.cov2.s (manufacturer was not specified) (suspension for injection, route of administration not specified) on an unspecified date for prophylactic vaccination.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration was not specified)  booster dose (series 2) on an unspecified date for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications were not reported. On an unspecified date, whilst waiting for 15 minutes of observation following his booster vaccination, he experienced a stroke.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of stroke was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211137111-covid-19 vaccine ad26.cov2.s-Stroke. This event(s) is considered unassessable. 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).
Patient called the pharmacy and  said she has developed a large rash and a baseball sized lump where she received the vaccine at another location.   Advised patient to go to a health urgent care or emergency room for evaluation.
Patient received  5 Through 11 Years of Age Pfizer-BioNTech COVID-19 Vaccine when they should have received Pfizer-BioNTech COVID-19 Vaccine  Age 12 and Over.
I am so sick. Nausea, extreme diarrhea with body aches, a fever, headache  and joint pain. It came on so fast.
drowsiness; flu like symptoms; confusion; This spontaneous case was reported by an other and describes the occurrence of SOMNOLENCE (drowsiness), INFLUENZA LIKE ILLNESS (flu like symptoms) and CONFUSIONAL STATE (confusion) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product VENETOCLAX (VENCLEXTA) for Chronic lymphocytic leukemia.    No Medical History information was reported.   On 28-Apr-2021, the patient started VENETOCLAX (VENCLEXTA) (Oral) 50 mg. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to at an unspecified dose. On an unknown date, the patient experienced SOMNOLENCE (drowsiness), INFLUENZA LIKE ILLNESS (flu like symptoms) and CONFUSIONAL STATE (confusion). At the time of the report, SOMNOLENCE (drowsiness), INFLUENZA LIKE ILLNESS (flu like symptoms) and CONFUSIONAL STATE (confusion) outcome was unknown.            Concomitant product use was not provided by the reporter. No treatment information was provided.   Reporter did not allow further contact
headache; nauseous; Lump where she received Shingrix; pain at the injection site; Felt wiped out  / tired; This case was reported by a consumer via call center representative and described the occurrence of headache in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included belimumab (Benlysta) solution for injection in pre-filled syringe for drug use for unknown indication, belimumab pre-filled syringe device injection syringe (batch number Unknown, expiry date unknown) for drug use for unknown indication, TETANUS TOXOID (TETANUS VACCINE) for prophylaxis and PNEUMOCOCCAL VACCINE (PNEUMONIA VACCINE) for prophylaxis.   On 30th July 2020, the patient received Shingrix. In June 2020, the patient started Benlysta 1 dosage form(s) weekly and belimumab pre-filled syringe device. On 29th July 2020, the patient received TETANUS VACCINE and PNEUMONIA VACCINE. On 30th July 2020, less than a day after receiving Shingrix and less than a week after starting Benlysta and belimumab pre-filled syringe device, the patient experienced tiredness. On 31st July 2020, the patient experienced headache, nausea, injection site lump and injection site pain. The action taken with Benlysta was unknown. On an unknown date, the outcome of the headache, nausea, tiredness, injection site lump and injection site pain were not recovered/not resolved.   The reporter considered the headache, nausea, tiredness, injection site lump and injection site pain to be related to Shingrix. It was unknown if the reporter considered the headache, nausea and tiredness to be related to Benlysta and belimumab pre-filled syringe device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: On 13th June 2020 the patient start taking Benlysta for 7 weeks.  On 1st August 2020 would be her 8th dose.  On 29th July 2020, the patient received pneumonia and tetanus vaccines  On 30th July 2020 same day after receiving Shingrix and one day after receiving pneumonia and tetanus patient experienced felt wiped out and tired. Two days after receiving pneumonia and tetanus vaccines the patient experienced headache, nausea, injection site lump and injection site pain.   The patient was not sure if she would take her Benlysta after the day of reporting. The reporter did not consent to follow up.
One week after initial dose my arm started itching, a red area about 4" x 4" appeared with 7-8 red/pimple-like spots. Today, 3/6/21, the area is becoming fainter and is slightly itching. I have been applying  a cortisone cream.
7 days post injection, I developed a noticeable bruise around the injection site after the initial bruise went away after 3 days post injection. The next day the area around the injection site turned bright red, was inflamed, and warm to touch. On Sunday, day 9 post injection,  the spot had grown to most of my upper arm, was severely inflamed, and hot to touch. I went to the urgent care, who diagnosed me with Covid arm and prescribed a 7 day  antibiotic, over the counter allergy meds, and a warm compress. Most of the symptoms went away after the antibiotic was complete in 7 days although some lingering redness. Followed up with my primary care doctor office, 11 days after the urgent care visit, who thought there was still some redness and warmth and gave me another 4 days of antibiotics.
After I received my first dose the area around my lips felt numb for a few minutes and then that feeling started going away and the feeling disappeared by the end of the first day. I also had on and off aching feelings from the injection spot. I also had disappearing headaches that rotated with the aching on my arm at the injection spot. The Getwell Network directed me to include this issue here.
Large Local Reaction in the left thigh (warm red lump at injection site measuring 4x6cm).
On 10/16/00, 15:00, pt complained of stomachache, 16:30, lips swollen, roof of mouth itching, runny nose, puffy eyes and stated she had hard time breathing; at 18:00 went to Urgent care and MD stated possible immunization reaction as there were no other allergies. Gave her epinephrine shot and she felt better.
After 2nd dose vaccine on 2/14/21 of Pfizer, got a very bloody nose beginning 2 days later and continuing 3 days later. Nose blood dried up but was very irritated for a total of 5 days
Face flushing within 1/2 hour that then subsided within another 1/2 hour.  6 1/2 hours after inoculation, at 7pm, I began to feel unwell.  I felt a burning all over my body (especially my back), and body aches, and began a fever which grew from 97.3 (my normal) to a high of 100.1  (+2.8 degrees) within 2.5 more hours (by 9:30pm).   Very bad chills and fever.  By 9:30 took 1 500mg Tylenol.   Little sleep that night.  Felt very unwell next day (3/9) including headache.  At noon I could get up and get some food.  By 1pm fever subsided completely, but temporarily.  Fever came back by 4pm, but only to 98.6 (+1.3 above normal).  Took another 500mg Tylenol.  Night 2 slept well. Woke up 3/10 no fever, headache gone, but balance still peculiar.  I noticed the first night that my sense of balance was off.
Initial report was received 15 October 2010 from a health care professional which involved a cluster of three patients (one male and two female). This case captures two female patients. The third patient has been captured in case number 2010-05974. Two female patients (ages and dates of birth not reported) had received an injection of FLUZONE SV 2010-2011, lot number U3720AA (routes and sites unknown) on 13 October 2010 and two days later on 15 October 2010, they experienced shortness of breath (SOB), upper respiratory infection (URI), "puritis", swelling of eyes, irritable throat and lymphadenopathy. Corrective treatment consisted of steroids. Concomitant medications and relevant laboratory and diagnostic testing were unknown at the time of the report. Outcomes were reported as unknown. Documents held by sender: None.
Numbness in my finger, toes and now right lower leg; This case was reported by a consumer and described the occurrence of numbness in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th June 2019, the patient received the 1st dose of Shingrix. On 27th June 2019, less than a day after receiving Shingrix, the patient experienced numbness. On an unknown date, the outcome of the numbness was unknown.   It was unknown if the reporter considered the numbness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient reported that, the physician performed blood test were normal. Since from the day of vaccination, the patient started feeling of numbness in finger, toes and now right lower leg.      Lab Comments: Blood test performed on an unknown date
Glands swollen; Coughing; Abdominal discomfort; Diarrhea; Weak; Dizzy; Headache; This is a spontaneous report received from a contactable consumer patient (daughter) that. A 36-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), dose 1 via an unspecified route of administration on 20Mar2021 (Batch/Lot number was not reported) as DOSE 1 SINGLE for covid-19 immunization. The patient past Medical history included clostridium difficile colitis from an unknown date and unknown if ongoing five years ago and she knows that is involved with the bowel.  The patient's concomitant medications were not reported. Caller states that her daughter just called her. States that her whole family has gotten the Pfizer vaccine, but the women are having abdominal pain, and her daughter also has diarrhea. States that her daughter just had the vaccine 3 days ago. States that her daughter asked her to do some research to see if this is a normal side effect of the vaccine. Caller states that she is two weeks past her vaccine, and she has her next dose after that, but she is having a lot of problems now. States that she is wondering if this is something that people are having? States that she is not seeing it listed as one of side effects. States she looked online as well, and it doesn't seem to be popping up. States that she is wondering if she [her daughter] should go for second since she feels so sick? States the day of shot, her daughter felt weak and dizzy and had a headache later that evening on 20Mar2021. She had abdominal discomfort and diarrhea starting 21Mar2021and this is her third day into it. She states her glands are swollen starting today. States that her daughter is not long weak and dizzy. States the rest of the symptoms are ongoing. States that she also started coughing two days ago. Treatment: States she doesn't think there was any treatment. Caller states her daughter isn't a person that resorts to treatments. No medications, medical conditions, or tests that are relevant. The event outcome Not recovered for Headache, Abdominal discomfort, Diarrhea, Glands swollen and cough and recovered for weak and dizziness on an unspecified date in 2021.  Information on lot/batch number has been requested.
49 Y female with h/o Graves disease and opthalmopathy, h/o difficulty with intubation, s/p Pzifer vaccine (12/20 and 01/21), presented 7/24 secondary to fever and shortness of breath and admitted for acute hypoxemic respiratory failure secondary to COVID pneumonia. Due to worsening respiratory failure, she was transferred to the ICU on 7/31/2021 - 8/4/2021 and was placed on HFNC with iNO. She completed 5 days of remdesivir (7/30 - 8/3), tocilizumab x2 (7/31, 8/1) and was treated with high dose steroids. On 8/4 due to respiratory stability and significant improvement, she was transferred out of the ICU.    Acute hypoxemic respiratory failure/COVID-19 DISEASE - s/p Pzifer vaccine (12/20 and 01/21), S/p HFNC with iNO, remdesivir (7/30 - 8/3), tocilizumab x2 (7/31, 8/1) and high dose steroids. S/p levoquin (7/31 - 8/3), vanco (8/1-8/2), was discontinued since one set of blood cx NGTD, 2nd set of blood cx 2/2 coag neg GPCs thought to be contaminant.  - Decadron 6mg daily 7/30, solumedrol 125 q6 8/31-8/3, reduced to 60mg q6 8/4, 60 mg TID 8/5 and down to Decadron 20 mg daily today, 8/6. Plan continue Decadron 20 mg x48 hours, then 10 mg x48 hours, then 6 mg daily for 48hrs.   - tessalon perles, guaifenasin prn cough - Improved VTE score of 1, 0.6% risk of VTE in next 3 month.  - Continue Isolation per county guidelines.    H/o Depression/anxiety - Continue PTA sertraline, clonipin 0.5 mg BID PRN for anxiety   H/o Anemia Stable. no bleeding   Hx of Graves disease and opthalmopathy (not on PTA meds) - TSH 0.3, low. Likely euthyroid sick syndrome I/s/o covid infection - Follow up TFTs as OP.    Prediabetes -  last A1c 5.9 on 7/30/21. BG 95. - CTM   Primary Procedures:  None   Secondary Procedures: None   Reason for Hospital Admission (Admitting Diagnosis):  COVID pneumonia
limited tenderness in the vaccination site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (limited tenderness in the vaccination site) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. D44A21A and 037B21A) for COVID-19 vaccination.     Concurrent medical conditions included Crohn's disease.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Mar-2021, the patient experienced VACCINATION SITE PAIN (limited tenderness in the vaccination site). On 17-Mar-2021, VACCINATION SITE PAIN (limited tenderness in the vaccination site) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-May-2021, Antibody test: negative (Negative) Antibody test Negative.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Relevant concomitant medications included, immunosuppressant medications for Crohn's disease.   Treatment information was not provided.   This case was linked to MOD-2021-200636 (Patient Link).
Patient received his first Covid vaccine on 11/30/2021.  He should of returned to the clinic on 12/21/2021.   He was scheduled by the front desk to return on 11/8/2021.   He was given the second dose. Tthe shot room nurse noticed when she was filling out his card.  She notified the patient immediately and the nursing supervisor. Patient was stable and instructed to call the clinic if he has any adverse reaction to the vaccine.   Front desk supervisor notified.   Front desk lead is to check all appointment for patient returning for second dose.  Shot Room nurse was given a reprimand and told to check card and chart before administering the Covid Shot.    Patient reported reaction on 12/14/2021 and was seen same day.  He states symptoms started on six day earlier.  Symptoms included headache  left arm pain,  and pain in the arm pit area.    OTC Advil was recommended.
Congestion, sore throat, Chest pain, Nausea, vomiting, weakness, arthralgias
Right side of his neck started to become tight and sore. No breathing difficulty or swelling noted.
Information has been received from a 71 year old male consumer with sulfur allergy and no pertinent medical history who on 10-AUG-2010, was vaccinated with a dose of ZOSTAVAX (Merck) (Lot#: not reported). Concomitant therapy included aspirin and metoprolol. The consumer stated that on 10-AUG-2010, after receiving ZOSTAVAX (Merck) his urine was very dark. The consumer did not seek medical attention. At the time of the report, the consumer had not recovered. Follow-up information was received from a physician who stated that on 10-AUG-2010, the patient had noted brownish urine hours after the patient had received the ZOSTAVAX (Merck) vaccine; it occurred a few more times though lighter each time. On 13-SEP-2010, the patient had a urine test performed. The results showed a yellow color and a clear appearance urine (all results were in range), and a small (1+) blood in urine (out of range). On 18-AUG-2010, the patient had another urine test performed which showed negative blood in urine. The urine culture showed no growth. The diagnosis was benign and there was no evidence of malignancy identified. On an unspecified date, the patient recovered on own. Additional information is not expected.
No harm and no adverse event due to error that was reported .  Patient was under dosed due to receiving the wrong label Moderna bivalent at 0.2/10mcg, instead of the .25mcg for both doses.
Rapid heartbeat; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (Rapid heartbeat) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     Concurrent medical conditions included Supraventricular tachycardia, Anxiety and Stress.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HEART RATE INCREASED (Rapid heartbeat). At the time of the report, HEART RATE INCREASED (Rapid heartbeat) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient was not sure whether the side effect was due to her not having eaten, slept well, being dehydrated, stressed, or due to the vaccine itself. After she went home, ate, slept and drank some fluids, the patient's symptoms eventually went away. The patient admitted having a stressful day and she did not experience any shortness of breath. No concomitant medications reported by the patient. No treatment medications were provided.    This case was linked to MOD-2021-090310 (Patient Link).
Developed lumps on jaw and back of neck.  Ichy.  Leaking after second day.  Sore.
cough, fever, short of breath started on 11/27. Admitted to the hospital 12/3