chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a registered nurse concerning an 18 year old female with no drug allergies and no medical history, who on 19-JUL-2007 was vaccinated intramuscularly with a 0.5mL first dose of Gardasil (Lot# 658100/0525U). Concomitant vaccination included MENACTRA. Concomitant therapy included CLARITIN. Within 24 hours the patient experienced "chest tightness" over her sternum. The patient sought unspecified medical attention. No laboratory diagnostics were performed. At the time of the report, the patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested.
Upper (L) D 1 cm, Lower (L) D 3.5 cm Red - slightly swollen.
prev dose brand=Moderna / prev dose number=1 / prev dose number=2; prev dose brand=Moderna / prev dose number=1 / prev dose number=2; Fainted about 10 minutes after my booster shot.; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 43-years-old female patient received bnt162b2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 15Nov2021 15:00 (at 43-years age old) as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunisation. The patient had no relevant medical history and no allergies. Concomitant medication(s) included allopurinol (ELAVIL [ALLOPURINOL]) for unspecified indication, start/stop date not reported. The historical vaccines include Moderna vaccine (batch/Lot number: Unknown), via an unspecified route of administration on 14Feb2021 (at 43-years age old) as DOSE 1 and via an unspecified route of administration on 14Mar2021(at 43-years age old) as DOSE 2 SINGLE for COVID-19 immunisation. The patient had no COVID-19 prior vaccination. The patient was not tested for COVID-19 post vaccination. The patient fainted about 10 minutes after her booster shot on 15Nov2021. The event was assessed as serious (medically significant). No treatment was taken for the events. The event outcome was reported as recovering.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Sep2022 at 17:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 55 years, in left arm 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 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Diabetes mellitus" (unspecified if ongoing). There were no concomitant medications. The following information was reported: COVID-19 (non-serious), outcome "not recovered", described as "COVID 19 Treatment". Therapeutic measures were taken as a result of covid-19. Additional information: Patient received treatment Paxlovid from 05Oct2022 to 09Oct2022. 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.
Symptoms: Urticaria on torso, upper extremities, neck and face 58 hours after ingesting 1st of 4 capsules  and 10 hours after ingesting 2nd of 4 capsules of Vivotif Typhoid Vaccine Live Oral Ty21A. Treatment: Stop vaccine course. Administer Benydryl to ameliorate allergic reaction.
Received #2 COVID vaccine 2/23/21. While taking bedtime meds pm 2/25/21, sudden onset very severe chest pain/pressure midsternum as if pill swallowed "sideways". No changes in BP, pulse or ECG trcing on fitness watch. Felt pain due to GI issue. Pain (less severe) con't through weekend, also noticed onset of palpitations. Saw primary dr 3/2/21. She ordered labs, barium swallow, ziopatch x 7 days, GI consult, did ECG in office. Only ziopatch showed results with runs of SVT, & PVC's. My primary Dr ordered a cardiac consult. Cardiologist ordered stress test (essentially normal), echocardiogram. Cardiologist said echocardiogram showed some pericardial effusion - didn't know why I woulld have that. I will have a repeat echocaRdiogram on 8/31/21. Have Not yet discussed possible vacciNe event with cardiologist. To see cardiologist 9/10/21.
Information regarding PREVNAR 13 was received from a consumer regarding a 4 month old female patient who experienced bronchiolitis described as coughing and wheezing. The patient received the second dose in Aug 2010 and the first dose in Apr 2010. Relevant medical history was not provided. Indication for PREVNAR 13 was immunisation. The dose regimen was 1 dose 1 time per day in Apr 2010 and then was 1 dose 1 time per day in Aug 2010. Additional suspect medication included ROTARIX. Concomitant medications were not reported. About two weeks after the patient received her initial dose of PREVNAR 13, in Apr 2010 or May 2010, she began to experience having bronchiolitis described as wheezing and coughing. She was treated with inhalation of unspecified nebulized medications. The reporter states she brought her daughter to a physician, then to an emergency room due to bronchiolitis, however her daughter was not admitted to the hospital and there were no laboratory tests performed due to the event. In 2010, bronchiolitis resolved. On 31 Aug 2010, she received her next dose of PREVNAR 13 and she was not given any other vaccinations at this time. On 01 Sep 2010, the coughing and wheezing returned due to which the patient again saw a physician on 03 Sep 2010 and due to which the patient was restarted on inhalation of nebulized medications once more. In 2010 after her recurrence of symptoms the reporter states her daughter's physician said she had never heard of the patient's event being associated with PREVNAR 13, however the reporter states she has done research and found information that reads similar events have been associated with PREVNAR 13. On an unspecified date, in 2010 the event resolved for the second time. No additional information was available at the time of this report.
Rash, fever, fatigue, diarrhea, ear pain, treated with Zithromax for otitis Media, treated with Aveeno bath and Benadryl for Varicella rash.
SYNCOPE, PALE, COLD, UNRESPONSIVE X 30 SECS, ASSISTED TO FLOOR, WOKE UP, PARAMEDICS ON SITE, BP 141/72, HR 91, PROVIDED WATER, SX RESOLVED, NO TRANSPORT.
Sudden blood clot in right leg; Dose Number: 1, Date of start of drug: 26Mar2021 / Dose Number: 2, Date of start of drug: 26Mar2021; Dose Number: 1, Date of start of drug: 26Mar2021 / Dose Number: 2, Date of start of drug: 26Mar2021; This is a spontaneous report received from a contactable consumer (patient).   A 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: ER2613) via an unspecified route of administration in left arm on 26Mar2021 (age at vaccination 46-year-old) as dose 1, single and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: EW0161) via an unspecified route of administration in right arm on 26Mar2021 at 11:00 (age at vaccination 46-year-old) dose 2, single for Covid-19 immunization at workplace clinic. Patient medical history was not provided. Patient was allergic to sulfa, hydrocodone and hydrocodone. Patients concomitant medications included dicycloverine hydrochloride (BENTYL), desogestrel, ethinylestradiol (AZURETTE), amylase, ascorbic acid, cellulase, folic acid, lipase, protease nos, ergocalciferol (CALCIFEROL VIT D) and cyanocobalamin (VITAMIN-B12-RATIOPHARM). Patient did not receive any other vaccines within 4 weeks prior to covid vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 08Jul2021 at 05:00 patient experienced sudden blood clot in right leg. Patient did not have history of blood clot. Adverse events resulted into doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Treatment received for adverse event sudden blood clot in right leg was blood thinner injection and continuing on it. The outcome of event sudden blood clot in right leg was recovered with sequel. Device date was given as 24Jul2021.  Follow-up (27Jul2021): Follow-up attempts are completed. No further information is expected.  Follow-up attempts are completed. No further information is expected.
Report completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose01/06/21 2nd dose01/27/21 Diagnosed covid positive:09/01/21 Symptom onset:09/01/21 Exposure: symptoms:fever, runny nose,sneezing
The day following her immunization , she said her nose started to run and then burn.  She has a severe herpes simplex or herpes zoster on her lips, surrounding area,  she claims it is down her throat and her ears are hurting a little.  She was not able to be seen by dr.  He called in Valtrex.  I told her she should be seen.  She has had "cold sores" in the past but never this bad and she has not had them for a long time.   She had a flu shot last year and did not have this reaction.  Did the combination of  two immunizations strain her immune system ?   I asked if anything had been stressing her out .  She said she had been in a lot of pain.
Newly hired Medical Assistant mistakenly interpret physician orders and incorrectly  administered Kinrix (DTap & IPV combo) vaccine.  She believed she was saving the patient from receiving multiple  vaccine shots.   No treatment needed and no adverse effect was reported by parent
Severe arm pain and redness at injection site, pain extending under the arm and into the chest wall left breast area. Fever 100.5, muscle and joint pain interfering with ADLs. Headache x48 hours.
Severe pain/redness of R upper arm, malaise, achiness. Progressed to severe swelling/redness of entire upper arm, extending to lower arm. Total area involved entire upper arm and inner lower arm.  Have photo from 48 hours after inj.  Began to subside on 10/19/2010. Swelling still apparent on 10/20/2010. General malaise/soreness for three days.
DURING receiving the vaccine I immediately felt it rush up my neck in a straight line and my ear started hurting.  My jaw hurt and right side of neck. It was as if  I had a central line in my neck and could feel it shoot right up in a straight line.  Ever since my whole right side of neck hurts and ear. I now have a bad cough I didn?t have and it?s day 4 since shot. The whole shot felt so freaky I will NOT receive the 2nd. I?m extremely scared what this caused feeling it in my neck. I ask the pharm d to pull back  on syringe to check  placement of needle. I?m extremely scared of what this might have  done.
Swollen supraclavicular lymph node  above his left clavical. Noticed for the first time six days later on May 24, 2021.
vomiting, chills, slight fever, diarrhea just started on 5/8 not sure how long they will last
This spontaneous report as received from a healthcare worker refers to a patient of unknown demographics. No current condition was reported. No historical drug was reported. On 08-APR-2014, the patient was vaccinated with ROTATEQ  lot # H017721, expiration date 01-APR-2014, dose 1 (dose strength and route ws not reported). No concomitant medication was reported. On 08-APR-2014, the patient received his first dose of ROTATEQ with an expired dose of ROTATEQ. No adverse effect was reported. No product quality complaint involved. Additional information is not expected.
Gave Hep A #1 on 2-3-05 @ 2:00 p.m. Child had a seizure on 2-5-05 around 1:00 p.m. Was taken to MD on 2-7-05 and was treated for an ear infection
Information has been received from a registered nurse concerning a 15 year old male patient with a seasonal allergy who on 11/12/1998, 12/15/1998, and 05/18/1999 was vaccinated with a dose of hepatitis B virus vaccine rHBsAg(yeast) There was no concomitant medication. On 04/25/2002, The patient developed benign premature ventricular contractions, which was reported as medical "history" On 07/12/2004, a titer was - for surface antigen and antibodies. Unspecified medical attention was sought but treatment was not required for the negative titer A product, quality complaint was not involved. Additional information has been requested.
Extremely sore arm first 3 days Today , 2 weeks later, injection site is sore and swollen with red itchy rash
On 4/3/21, broke out in small spots all over body; by 4/7/21, the spots were breaking out as large hives all over body; taking Benadryl and applying anti-itch cream; on 4/9, primary care doctor recommended I switch to Claritin and Pepcid; 4/9-4/18 hives were getting worse every day; took 6 day course of Prednisone; hives cleared up after 3 days on Prednisone, but then hives intensified even more on days 4-6 of Prednisone taper; took 40 mg of Prednisone for 2 days; hives reduced; switched to Zertec twice a day and Pepcid twice a day; hives are decreasing but still appearing daily
The sight felt a little itchy the evening that it was given. When I woke up I had a tennis ball size raised, red, warm spot on the back of my arm where injection was given. It was still itchy. The next day I woke up to the same spot on my arm only it was the size of a softball and more itchy. I went to the pharmacist after I got off work. He told me to report it and put ice on it.
Woke up with Nausea and vomiting all day 4 days later.  Took Zofran for the vomiting.  Also had a migraine and fatigue. Resolved in approx 8 hours
This spontaneous report received from a consumer, concerned a female of unspecified age. Medical history, weight, height, concomitant medications and concurrent conditions not reported. The patient received COVID-19 vaccine ad26.cov2.s (suspension for injection, route of admin and batch/lot number: not reported) dose: not reported, on Apr 7, 2021, for immunization. Unable to perform follow-up to request batch/lot numbers. On Apr 8, 2021, patient experienced a fever 24 hours after vaccination. The action taken with COVID-19 vaccine ad26.cov2.s: not applicable. The outcome of fever 24 hours after vaccination: not reported.
On 12/3/21 AT 12:20 pm patient presented to our pharmacy to get covid-19 booster vaccine for Janssen vaccine. after receiving the vaccine by nurse patient fainted. Ambulance was called for the patient and when they arrived patient started feeling better . Blood pressure reported by nurse was 119/56 mmHG. sitting. Patient denied need for hospitalization and was helped to go to his car after he started feeling better.
Progressive symptoms of mild itchyness of skin all over body on first day to painful pin and needles sensation with continued itching over entire body only occuring at night by day 7 . Symptoms are temporarily relieved with zyrtec and famotidine.  Symptoms are ongoing and getting progressively worse each night. No rashes are observed so far. Headache and severe dizziness with nausea were experienced on day 4 but only lasting 4 hrs.
11 days after receiving the shot, the injection site is red and hot with very slight itching and pain, but nothing I feel I need to take anything for.
This vaccine was given and unfortunately we missed the patient's age and gave her a 65+ HD vaccine when she is only 60. We did not realize the mistake until we came back to the store and processed the vaccine.
lt arm tender swollen hard base was red;administered 2-3" above elbow not in upper arm;PO antihistamine-prescription per MD localized rxn;now improving not as hard/red;no more tetanus or diphtheria shots per MD;
Developed  right lower quadrant pain over 3 days (02/9-11) which improved. Symptoms returned on  2/17.  Went to emergency room on 2/18.
8:50 am given injections. 8:52 reported feeling dizzy and lightheaded. Passed out and helped to floor. unconscious for about 20 seconds with agonal breathing and seizure like movement of upper extremities while out. vital signs: 8:52 am 135/85 alert P 65 O2 sat 100%  Blood sugar 98 sweaty and pale 9:03 131/95 P-64 Resp 20 Alert and orientated. REported feeling better  Evaluated by provider and transported to Regions ED for further evaluation as patient and wife felt more monitoring needed.
This spontaneous report as received from a Licensed Practical Nurse (LPN) refers to a 5 year old female patient with none concomitant medications, pertinent medical history or drug reactions/allergies. The LPN reported that in September 2011 the patient was vaccinated with (merck) VARIVAX (lot # H017440, expiration date 19-SEP-2014), first dose, 0.5 ml, subcutaneous (anatomical location unspecified). On 08-MAR-2013 the patient was vaccinated with (merck) VARIVAX (lot # and expiration date unspecified) dose 2, 0.5ml, subcutaneous (Anatomical location unspecified). The LPN reported that on 10-MAR-2013 the patient developed a varicella-like rash around the injection site. Nurse stated that the lesions were localized to the injection site. The patient was seen by pediatrician on an unknown date. The pediatrician cultured the vesicles at the injection site for Varicella zoster virus (VZV) identification done in the office on an unknown date. No treatment was given. At the time of the report the outcome of varicella-like rash at the injection site was unknown. Additional information is not expected.
0.5ml fluviron was given to patient.  Vaccine for 44 yrs and older.  Warning on box but not on actual vial.  Patient had no reaction.
Breakthrough case admission after 3 admits Moderna 2/14/21 Lot# 038K20A;  Moderna 3/14/21 Lot# 03021A;  Moderna 12/1/21 Lot# 021H21b
Patient called to inform that she has swelling at the injection site with itching. Suggested to take BENADRYL.
swelling an loss of strength in both arms an hands pain an loss of feeling in right hand unable move my shot arm up or down knots in muscle where shot was administered.after 6 weeks not completly well
About a week after I received my first moderna shot, my arm began developing a odd red rash. Itchy and felt super hot like a sunburn. Went away after 3 days.
12-year-old patient received an adult dose of Havrix; 12-year-old patient received an adult dose of Havrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of overdose in a 12-year-old male patient who received HAV (Havrix adult) (batch number 772YT, expiry date 23-SEP-2025) for prophylaxis.   On 06-JUL-2023, the patient received Havrix adult. On 06-JUL-2023, an unknown time after receiving Havrix adult, the patient experienced overdose (Verbatim: 12-year-old patient received an adult dose of Havrix) and inappropriate age at vaccine administration (Verbatim: 12-year-old patient received an adult dose of Havrix). The outcome of the overdose and inappropriate age at vaccine administration were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 20-JUL-2023 The vaccine administration facility was the same as primary reporter. The reporter consented to follow up. 12-year-old patient received an adult dose of Havrix, which led to overdose and inappropriate age at vaccine administration.
This spontaneous report as received from a Nurse refers to a patient of unknown demography. The reporter stated that the patient received the first dose of VARIVAX (Merck) (dose, route and frequency were not reported) on 31-AUG-2009. On 29-JUN-2012, the patient received the first dose of M-M-R II (dose, route and frequency were not reported). The reporter stated that on 01-AUG-2012, the patient received the recommended dose of VARIVAX (Merck) Lot# H006462, (dose, route and frequency were not reported). On 23-AUG-2012, within the 28 day interval, the patient received the recommended dose of M-M-R II. No adverse effects reported. No further information was reported. Additional information has been requested.
I?m a very healthy person & never had any major health problems until I took the first dose of Pfizer .  The day after I took it I started having major side effects. I started out feeling drained/body aches & horrible head pressure. I knew that was probably normal at first, but each day instead of getting better I got worse.  2 days after that I started having tingling feelings all in my right foot- going up my leg into my right hand. I couldn?t hardly walk to the kitchen without feeling like I would pass out.  Extreme fatigue & weak in my legs.  This went on for days until I did pass out & ended up in the ER. Horrible head pressure during all of this that would not let up. 2 days after that I stated experiencing eye pain which was the scariest for me. I couldn?t hardly open my eyes bc the pressure. Went to the eye Dr & he said I had inflammation in both eyes. Went to the neurologist because the head pressure was so extreme. Put on different migraine medicine, but nothing helped eased it.  I started having dizziness & found out my blood pressure was dropping 50/48. I am still going through these symptoms & it?s over a month later.
Patient complained of a worsening reoccurrence of her paroxysmal atrial fibrillation after receiving the vaccine.  Patient reported to her health care provider for an adjustment of medication she was already taking for this condition.  Patient also states that she experienced fatigue and shakes.  The afib symptoms have improved but not fully resolved at time of reporting.
patient got the IPOL dose that was not viable after the temperature excursion with no reported adverse event; Initial information received on 29-Sep-2023 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional.  This case is linked to case 2023SA303379.  This case involves a 9 months old male patient who patient got the IPV (VERO) [IPOL] dose that was not viable after the temperature excursion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included diphtheria vaccine toxoid, pertussis vaccine acellular 3-component, tetanus vaccine toxoid (Infanrix) for Immunisation.  On 27-Sep-2023, the patient received 0.5 ml dose of suspect IPV (VERO) Suspension for injection (lot- W1A191M and expiration date- 16-Feb-2025) via intramuscular route in the right thigh (strength: not provided) for Immunisation (poor quality product administered) (latency- same day).  Only 2 patients got the IPOL dose that was not viable after the temperature excursion.  Action taken- not applicable.  At time of reporting, the outcome was Unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Information has been received from a certified medical assistant concerning an adult female who was "recently" vaccinated intramuscularly with a 0.5 mL dose of Pneumovax 23 (lot 651319/1007P).  The patient was concomitantly vaccinated with influenza virus vaccine (unspecified).  Subsequently the patient developed injection site pain, redness and swelling.  The patient sought medical attention and was treated with ADVIL.  Subsequently, the patient recovered.  Additional information has been requested.
Local irritation at site of occlusive dressing, satellite lesions appears consistent with vaccine site.
28 weeks pregnant with twins. About 8 hours after vaccine I experienced heart palpitations and uterine contractions. Delivered at 34 weeks gestation via csection. Twin A 5 pounds 5 ounces. Twin B 4 pounds 15 ounces.