chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A patient received an expired vaccine, no AE; Initial information regarding an unsolicited valid non-serious case was received from other healthcare professional via Medical Information (Reference number- 00600408) and transmitted to Sanofi on 13-May-2021.  This case involves a male patient (age not reported) who received 0.5 mL dose of an expired MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot U658BA and expiry date: 20-Apr-2021) via an unknown route in an unknown administration site for prophylactic vaccination on 13-May-2021 (expired product administered).  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   The medical assistant (MA) was calling to get more information in regards to expired MENACTRA had been administered.   This was a case of actual medication error case due to expired vaccine used (latency same day).  At the time of reporting, no adverse event was reported.   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.
Had the vaccine, had no reaction until a few days later when she had dizziness, also waviness, loss of stability.  She went to 3 doctors, ENT and he gave her a steroid Methylprednisolone which did not help after two rounds of it.  Then he sent her to a neuro/Otolaryngologist.  She is still having the same symptoms.
4 cm x 3.5 cm erythematous, warm, raised, round patch to patients left deltoid where injection was given.
On 12/17/2002, pt reports Influenza vaccine administered on 12/10/2002 at injection site redness/ swelling size of silver dollar on 12/14/2002. No meds required. used compresses to site. Resolved 12/16/2002.
Initial report received from a health care provider on 27/Mar/2006. A five-year-old patient (gender not reported) had received an intramuscular, right arm injection of Daptacel, lot number C2405AA, on 22/Mar/2006. Two days later, the patient experienced "redness and swelling of the entire arm after vaccination". The patient had received four previous doses. At the time of this report, the patient had recovered from the event. The report in this case is the same as for cases 2006-00693, 2006-00695, 2006-00696, 2006-00697, 2006-00698, 2006-00699, and 2006-00700.
Tingling and numbness around mouth starting 20 minutes after vaccine and lasting 3 hrs. Extreme pain at injection site for 3 days
On 4/6/2021 at 8AM, I got the 1st dose Moderna vaccine (lot 025B21A IM LA), nothing significant except I felt a little tired. On 5/4/2021 at 8:30AM, I went ahead and got my 2nd dose of Moderna (lot 048B21A IM LA). Around noon, I started getting flu-like symptoms-nausea, dizziness, sleepy, no appetite, headache, low grade fever, and chills. It got better at the end of the evening. I took Tylenol and went to bed. On 5/7/2021, I thought I was getting hemorrhoids. I went to the pharmacy to buy some OTC products. I also thought I was having a UTI as well. I took a picture with my phone of my private parts and realized it was all red and inflamed down there. I called a telehealth doctor and was referred to another doctor to be seen in person. On 5/8/2021 I went in person to see the doctor and the doctor diagnosed me with shingles. I was also tested for all other STDS to rule it those out. I was prescribed a medication Valtrex for 7 days which resolved my shingles.
Child developed erythema around Varicella injection site on 10/5/10(vaccine given 9/24/10) and then 2 classic chicken pox lesions on her chest (clear fluid filled blister on erythematous base). Ten days later her mother, who had chicken pox as a child, developed 15 lesions diagnosed as consistent with chicken pox by an ED physician on 10/16/10. Appears to be case of vaccine-associated varicella transmission as family had no known wild-type varicella exposure. Both child and mother did fine--am reporting merely for epidemiologic purposes.
Received third dose and is not immunocompromised; This spontaneous case was reported by a consumer and describes the occurrence of OFF LABEL USE (Received third dose and is not immunocompromised) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Sep-2021, the patient experienced OFF LABEL USE (Received third dose and is not immunocompromised). On 01-Sep-2021, OFF LABEL USE (Received third dose and is not immunocompromised) had resolved.            Concomitant medication was not provided.  Treatment information was not provided.   Reporter did not allow further contact
Woke up one morning  extremely stiff with extreme pain in every joint in my body. Could barely walk. Was fine the day before. With aspirin and Tylenol I am beginning to move easier but still not as I was.
Very painful and inflamed right arm for 3 days that started on Friday morning. Friday night on 2/12 at 9pm started hurting in all joints and at 2am on 2/13 started severe nausea and felt heart beating fast in my chest, almost went to emergency room, but zofran helped.  Started feeling better afternoon. I have auto immune diseases bad and just wanted someone aware of what happened. I will be getting the 2nd dose when it is time.
irritated area at injection site about the size fo a golf ball hard red and warm to touch low grade temp 99.6-100 arm had sharp pain and aching
Started with normal low-grade fever. Went away after 3 days. Then came persistent Tinnitus and pressure above jaw, behind ears. No drainage or sinus-like problems. No congestion.
At 0330, began with very strong headache, dizziness, vertigo and ringing in my right ear.
This spontaneous report as received from a health care worker refers to unspecified number of patients of unknown age. It was reported that the RECOMBIVAX HB of unknown dose for prophylaxis, have undergone a second temperature excursion dated 2-JUL-2014 and have been administered post initial excursion reported as 16-JAN-2014. Excursion supported. It was reported that no adverse events and no concerns are reported by any patients. RECOMBIVAX HB have been administered since date of last excursion of 27-JAN-2014 is with Lot number reported as H010849 and expiry date reported as 28-FEB-2015. This is one of the several reports from the same source: different patients same reporter. Additional information has been requested.
First day, no pain in the arm, second day a bit of pain in the arm. Later that second day, started feeling heart flutters. This has been my 4th day with heart flutters. Symptoms are becoming a little less. Aside from heart flutters, no other symptoms have been felt.
I didn't put two and two together, but I've been tired and short tempered since getting the 2nd dose in May. I used to go to the gym and lift 4 days a week or more. I haven't been since, my membership has expired to my gym and I just don't have the energy to go and lift. I am able to do some hiking, but strength training is difficult for me. I'm signing back up for the gym, but I don't know if I'll lift like I used to.
19 Jun 2006, raised bumps on elbows and hands lasted through 30 Jun 2006.  Patient treated with ELIDEL ointment.
Severe burning in left knee joint. Lasted 6 days. Burning faded, but I am still having problems with knee
anaphylaxis; This is a spontaneous report from a contactable healthcare professional (patient). A 55-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date unspecified),  via an unspecified route of administration, administered in left arm on 05Dec2020 11:00 as single dose for COVID-19 immunisation; and amoxicillin, clavulanic acid (AUGMENTIN), via an unspecified route of administration from 18Mar2021 at unspecified dose for an unspecified indication. Medical history included myocardial infarction (MI), coronary artery bypass grafting (CABG), AV Nodal block, and pacemaker. The patient's concomitant medications were not reported. On 18Mar2021 20:00, the patient experienced anaphylaxis. The patient was hospitalized for 2 days on an unspecified date due to the event. The patient reported that he was on augmentin on and off for years and when he got his first vaccine. And on 18Mar2021, he began augmentin again and had anaphylaxis requiring hospitalization. The patient was asking if this was related to the vaccine, but seems to be a possibility. The event resulted in resulted in emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event). The event was treated with epinephrine, steroids, benadryl, and fluids. There was no other vaccine in 4 weeks and patient had not had Covid prior vaccination and was not Covid tested post vaccination. The action taken in response to the event for amoxicillin, clavulanic acid was unknown. Outcome of event was recovered in 2021.  Information on batch/lot number was requested.; Sender's Comments: Based on available information, the event anaphylaxis is assessed as unrelated to BNT162B2. The event occurred more than 3 months after the administration of vaccine and can be attributed to augmentin based on provided information, including close temporal relationship and positive rechallenge.
I received the first COVID vaccine on 15 October 2021 and the second vaccine on 12 November 2021. I found out that I was pregnant on 16 November 2021 and my due date was 27 July 2022. I started bleeding on 20 November 2021 and that continued for 40 days until I lost the baby on 29 December 2021. I had hemorrhaging very badly on 2 December 2021 and on 27 December 2021. I bled so much,  I temporarily blacked out and was shaking uncontrollably. After testing was completed on the fetus, it was found to have hemorrhaging between its eyes.
TRANSIENT CEREBRAL ISCHEMIA 3/24/2023 TRANSIENT CEREBRAL ISCHEMIA ACUTE STROKE, UNSPECIFIED TYPE AND ARTERY 3/27/2023 TRANSIENT CEREBRAL ISCHEMIA
Received vaccine on 1/26/21. Only experienced minimal soreness at injection site for 1-2 days. No other symptoms experienced. On 2/4/21 (9 days later) a reddened area appeared 4-5 inches surrounding site, erythema and pruritus, area warm to touch. No nodule or raised rash noted. Afebrile. Today 5 days later,the area is slightly larger with same symptoms.
A report was received from a health care professional on 11/19/03 concerning a female vaccinee more than 65 years old who experienced sinffles, cough, fever, and sore throat up to 1 week after receiving Fluvirin on approximately 11/6/03. On an unspecified date, up to one week after vaccination, the vaccinee experienced sniffles, cough, fever, and sore throat. Results of a chest x-ray taken on an unspecified date were negative. The outcome of the event was reported as unknown. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
Blood pressure was 200/100; Very dizzy; Could not lie down without things spinning around; Felt unsteady; Nauseous; A spontaneous report was received from a consumer concerning a 65-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced blood pressure raise (200/100) with dizziness, nausea, vertigo and gait disturbance.  The patient's medical history was not provided. Concomitant medications were not reported.  On 27 Feb 2021, 16 hours prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch number: 010A21A) intramuscularly for the prophylaxis of COVID-19 infection.  On 28 Feb 2021, the patient woke up to turn over and was very dizzy. The dizziness continue most of the following day, and the patient was also nauseous and could not lie down without things spinning around. The patient stayed upright and felt unsteady so they had to hold on to the walls to move around. The patient was taken to urgent care where her blood pressure was 200/100.  She was taken to the hospital where she remained for two days and tests were taken.  Treatment medications included nitroglycerin and acetylsalicylic acid.  The patient was released from the hospital on 02 Mar 2021.  She had an appointment with her PCP (primary care physician) on Friday 05 Mar 2021 for follow-up.    Action taken with mRNA-1273 in response to the events was unknown.  The outcomes of the events were reported as unknown.; Reporter's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.
10:00 - Patient still at shot table. States he felt lightheaded. Color pale. Encouraged to deep breathe, mask removed. States he feels like he is going to pass out. RN (clinic manager) at patient's side. Two additional nurses at patient's side. 10:12- Patient did not lose consciousness. Was able to stand with assist and moved to w/c. Patient taken to private observation accompanied per nursing and EMT. Pt. taken outside for fresh air.  HR 130 strong and regular. Unable to obtain BP due morbid obesity. RN recommended to patient to receive second dose of Moderna in a private clinic to be closely monitored and supine. 10:17 - Patient recovered. Declined ambulance. Patient stood, no lightheadedness/vertigo. Patient chose to ambulate to private vehicle, accompanied by wife.
Nausea,  arm numbness, weakness elevated blood pressure, (210/80) heart rate of  120bpm. All occurred 5 min post vaccination
anaphylactic reaction; Respiratory distress; Bilateral wheeze/bronchospasm; Shortness of breath, walking and severe if uphill/Difficulty breathing; Sudden Coughing outburst; Diarrhea; Migraine; Overall not well; Tachycardia; chest tightness; swollen left lymphnode and left breast; swollen left lymphnode and left breast; fatigue; This is a spontaneous report from a contactable Other-HCP (patient). This is one of two reports reporting the same patient/same drug with different dose (the first) and events  A 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EJ686), via an unspecified route of administration, administered in Arm Left on 04Jan2021 as single dose (at the age of 40) for covid-19 immunisation. No other vaccine in four weeks. No COVID prior vaccination. COVID tested post vaccination (nasal swab) was negative. Medical history included attention deficit hyperactivity disorder, gluten sensitivity, migraine. Concomitant medications included linaclotide (LINZESS), amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), topiramate (TOPAMAX), ibuprofen (IBUPROFEN). The patient experienced respiratory distress on an unspecified date, anaphylactic reaction on an unspecified date, tachycardia on 04Jan2021, chest tightness on 04Jan2021, swollen left lymphnode and left breast on 04Jan2021, fatigue on 04Jan2021, bilateral wheeze/bronchospasm on an unspecified date, shortness of breath on an unspecified date, walking and severe if uphill/difficulty breathing on an unspecified date, sudden coughing outburst on an unspecified date, diarrhea on an unspecified date, migraine on an unspecified date, overall not well on an unspecified date. No treatment.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events anaphylactic reaction, respiratory distress, bronchospasm and dyspnea and the suspect drug.  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.
from 6-13 surgeries, post polio synd;unable to work, debilitating pain lt leg;
This spontaneous report as received from a nurse refers to a 14 year old female patient. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. No previous drug reactions or allergies were reported. On 16-APR-2018, the patient was vaccinated with adult dose of VAQTA 50/1.0 U/ml (dosing details were not reported) (lot # N016805 expiry date: 04-SEP-2018) for prophylaxis. No adverse effects reported. No product quality complaint involved.
This spontaneous report was received from a pharmacist refers to a male patient of unknown age. Patient's pertinent medical history and drug reactions were not specified. On 05-JAN-2015 the patient was vaccinated with PNEUMOVAX23 (dose, frequency, therapy route, lot # and expiration date unspecified). Concomitant therapies included CRESTOR, LIPITOR and SINGULAIR. Since an unknown date, patient began taking SINGULAIR for an unknown diagnosis. Beginning on unknown date, patient developed lock jaws like symptoms and lower back pain. No product quality complaint (PQC) was involved. Patient took Ibuprofen. On an unknown date, patient sought medical attention and spoke with pharmacist. Over-the counter (OTC) medications were given as treatment for the adverse events. On an unknown date, lock jaws like symptoms resolved. The outcome of lower back pain was reported as recovering. Causality assessment was not provided. Additional information has been requested.
Headache; This is a spontaneous report from a contactable consumer (patient). A 91-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL9261), intramuscular in left arm, on 21Jan2021 (Thursday) at 08:45, at a single dose, for COVID-19 immunization. The patient's medical history included ongoing diabetes (diabetic) diagnosed about 50 years ago (1971). The patient's concomitant medications included glipizide and insulin glargine (LANTUS), both were ongoing for diabetes. The patient previously took the first dose of BNT162B2 (Lot Number: EL3046) on 02Jan2021 around 09:00 AM for COVID-19 immunization (in right arm). The patient had no other prior vaccinations within 4 weeks. The vaccine was administered in a (public) health department facility. The patient had second dose of the Pfizer COVID-19 vaccine on Thursday (21Jan2021) and from Friday morning (22Jan2021), he started experiencing headache and he cannot get rid of it. It had been 5 days. The patient took paracetamol (TYLENOL) and it is not helping. Today (26Jan2021), the patient went to the hospital emergency room (ER) but they did not see him since the ER was so busy; he sat in ER waiting room for 6 hours and he never got waited on so he left. The patient did not have physician office visit but is going to see his doctor tomorrow (27Jan2021) for the headache. The patient had not recovered from the event.
It was the first vaccine flu; Could not sleep; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 17May2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INFLUENZA (non-serious), outcome "unknown", described as "It was the first vaccine flu"; INSOMNIA (non-serious), outcome "unknown", described as "Could not sleep".  Additional information: I just had the Covid vaccine from Pfizer and you know what, instead of me getting the what you call this plan it only become bigger and bigger and then I could not sleep that night. I do not know why. It was the first vaccine flu. I did not get the second one yet and then I feel so different.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
First Moderna dose was 3 Mar 2021 at the Regulatory Authority.  Two-3 days after I began to develop severe left abdominal pain.  I went to the ER on 8 Mar 2021 was told I had diverticulitis.  I have never had gastrointestinal issues or pain before this.  I was put on an antibiotic and pain resolved itself a few days later.  2nd shot on 31 Mar 2021  was unremarkable other than the normal fever, muscle ache, and sick feeling for 2-3 days after.  3rd shot on 10 Dec 2021 was initially unremarkable in the 2-3 day period following other than the aforementioned symptoms.  On December 27, 2021 I began to feal very sick and on 28 Dec, 2021 I tested positive for Covid 19.  Covid 19 symptoms for me included high fever, chronic painful cough, sore throat, muscle ache, fatigue, diarrhea, thick amounts of phlegm and vomiting.  I did not lose taste or smell.  I went to the ER on 29 Dec 2021 for low blood oxygen.  I was given an albuterol inhaler and discharged.  I received monoclonal antibodies on 30 Dec 2022, but they seemed to have little impact.  On 17 Dec 2021 I went to the ER for low blood oxygen at 83.  I was discharged that night with no new medication, but an Xray showed partial collapse of my right lung.    I have been under the care of a Pulmonologist since 4 Feb 2022 and am currently taking Advair Diskus 250/50 and using a nebulizer with Budesonide and Albuterol.  Remaining covid symptoms that exist are chronic cough and thick white phlegm which I cough up and have to expel nearly every minute of the day, or else I been to gag and feel like breathing is being restricted.   I am a non-smoker nor a nicotine user.  Current assumption is Reactive Airway Disease and Antibody Dependent Enhancement due to the vaccines and catching Covid 19 soon after and my Covid turning into what's being called Long Covid.   I have been out of work since catching Covid 19 and current medications are not showing any sign of improving conditions.  My Doctor  is exploring other options and has referred me to the Regulatory Authority Clinic.
Moderna Covid 19 Vaccine. Pt reported that she felt sick 2 days after her first shot. She had joint paint, fatigue, was very tired, the area of the injection was hot and a little swollen about 2 inches wide. She took 2 benadryls which seem to help a little. She will start taking Claritin during the day and Benadryl at night for next few days to see if any improvement. She will draw along the perimeter of the affected area and check it daily to see if any improvement and will call her MD if fever occurs