chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Enlarged lymph nodes both armpits, painful to the touch; Schamberg's disease: discoloration on both lower and upper legs; Sore arm where vaccine was administered; Upset stomach; Constipation; This is a spontaneous report from a non-contactable consumer (patient). This is first of the two cases. A 30-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0175) via an unspecified route of administration in the arm on 05Apr2021 at 14:45 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Medical history was not provided. Concomitant medication included spironolactone, 100 mg (MANUFACTURER UNKNOWN) for an unspecified indication. The patient did not receive any other vaccines within four weeks prior to the vaccination. 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 an unknown date in Apr2021, one week after first dose of vaccine, the patient experienced enlarged lymph nodes in both armpits which lasted a few days and was painful to touch. On an unknown date in Apr2021, shortly after first dose of vaccine, the patient experienced Schamberg's disease: which included discoloration on both lower and upper legs and sore arm where vaccine was administered. On an unknown date in Apr2021, in the second to third week after the first dose, the patient experienced upset stomach and constipation. Therapeutic measures were not taken as a result of adverse events. The events resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the events enlarged lymph nodes in both armpits which was painful to touch, Schamberg's disease- discoloration on both lower and upper legs, sore arm where vaccine was administered, upset stomach and constipation was recovered with sequelae. (outcome of event Schamberg's disease also reported as not recovered)  No follow-up attempts are needed. No further information is expected.
Pt received flu vaccine on 10/17/17. About 8 hours later, she started getting tingling in her upper arm (arm that flu shot was given in) which extended up into her neck. The patient visited the ER to address this tingling. The tingling feeling would come and go and last anywhere from 10 minutes to 1 hour. She stated that she developed a headache associated with the tingling. She mentioned that she got the flu shot at the Clinic, and the shot hurt "really bad" when she got it, and thought the person giving it to her might have hit a nerve. She gets the flu shot every year, and this has never happened before; usually, she will get a circle of redness on her arm (about 3-4 inches in diameter), but she did not get that this year. ER doctor told patient to use TYLENOL/MOTRIN as needed for discomfort and instructed the patient to return if she had any increased symptoms, fever, worsening headache, or weakness in the left upper extremity. Patient was also instructed to f/u with the Clinic in the morning for a recheck. As of today (9/11/18), Pt still has pain in the arm.
Chest pain, vomiting after 4 days after vaccine  with resultant labs consistent with myocarditis (elevated troponin, ESR, and CRP). Being followed by cardiology.
Chills, aches, very mild headache since about 8:30PM last night.
Got the vaccine, and later  noticed pain in her neck, knees, head.  She had dizziness, chills, shakes, nausea and a slight fever.   She went to bed that evening and everything was hurting, and felt very nauseous.  She had a very bad nights rest, but when she woke up her temp was over 100, normal is 97.  She did take her morning meds and an extra-strength Tylenol and went back to bed.   She took Tylenol, was feeling better, but still the chills and fatigue and was better.  The problem with the headache continued and her temp was about 99.   On 2/12/21 had temp over 100 again, no energy, slept a lot.   Had difficulty sleeping that night and had sweats, had temp, nausea and was shaking.  On Monday felt shaky, chills and difficulty sleeping.  On Tuesday she was having headache, not sleeping well and no energy.   She also was not sleeping well, had  a headache.  By 2/17/21 was feeling better, not great as she was still not sleeping well.   She did have covid in April of last year, and was not allowed to see her husband who was in a nursing home until 6/3/20.   When she had the covid test she was inconclusive and that's why she could not see her doctor.   Her doctor did the antibody test that showed she had antibodies.  She is feeling back to normal as of today, 3/8/21.  She had the malaise from COVID after she got the 1st vaccine.  Feels that they should ask people before getting the vaccine if they had COVID.
Dental cavity; This is a spontaneous report received from a contactable consumer (reporting on herself). A 76-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot Number: EN6200 and Expiration Date was not reported), via an unspecified route of administration in Arm Right on 18Feb2021 12:00 as single dose for COVID-19 immunization. Medical history included atrial fibrillation, hypothyroidism, blood pressure ab-normal, hypoacusis all from an unknown date and unknown if ongoing. Concomitant medication(s) included levothyroxine (LEVOTHYROXINE) taken for hypothyroidism from an unspecified start date and ongoing (has been taking for at least 2 years); apixaban (ELIQUIS) taken for atrial fibrillation from 2018 and ongoing; diltiazem hydrochloride (DILTIAZEM CD) taken for blood pressure abnormal from 2016 and ongoing; metoprolol tartrate (METOPROLOL TARTRATE) taken for blood pres-sure abnormal from an unspecified start date and ongoing (has been taking for a couple of years); colecalciferol (VITAMIN D3) taken for an unspecified indication from an unspecified start date and ongoing (has been taking since at least 2016); cyanocobalamin (VITAMIN B12 [CYANOCOBALAMIN]) taken for an unspecified indication from 2016 and ongoing (She does not know why she takes this. She states she was low on something). Historical vaccine includes Flu shot. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that on 18Feb2021 first dose of the BNT162B2. She did not have any problems after getting the vaccine. She goes back on 11Mar2021 for the second dose. Patient mentioned that she was hard of hearing. Confirms this has been going on for a long time. She diagnosed with a cavity and has an appointment to have it filled the day prior to receiving the second dose. She has a dentist appointment on 10Mar2021 to have a cavity filled. Asking will this be a problem. She will probably have to have Novacaine but she does not know. Yesterday she went for a 6 month check-up and was found to have a cavity. She was scheduled for an appointment to have the cavity filled. Patient was asking should she cancel the appointment. She had a flu shot in Sep2020. She has not had any other vaccines. The outcome of the event was unknown.
Fever around 102 F; Chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), PYREXIA (Fever around 102 F) and CHILLS (Chills) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040B21A and 001A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Apr-2021, the patient experienced HEADACHE (Headache). On 11-Apr-2021, the patient experienced PYREXIA (Fever around 102 F) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at a dose of UNK, q4h. At the time of the report, HEADACHE (Headache), PYREXIA (Fever around 102 F) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Apr-2021, Body temperature: 102 (High) Fever around 102 F and 100.6 (High) 100.6 F.         Concomitant product use was not provided by the reporter. Action taken with mRNA-1273 in response to the events were not applicable.
He has arm pain after the immunization. He had redness, swelling and warmth at the injection site starting 4/6/17. The redness extended beyond the injection site from 4/6-4/7/17. By 4/7 the redness was of the upper arm and no further spread.
Client may have received Pfizer as her second dose instead of Moderna. Client was originally vaccinated on April 23rd, 2021 with Moderna vaccine.  When asked about the second vaccine she stated that she did not have her card so they gave her a paper but she could not find it. I asked her when she received the vaccine and she stated that it was not on the day on the back of the card but was on the day after or near. The vaccine was delivered. Over the course of 15 minutes the client said she received the vaccine in the mouth. This made me doubt the veracity of the previous statements about the second dose. I further asked the client about the clinic she received the vaccine from and the doctor and she was very vague.
Pt developed a dark red bruise-like rash and small bumps around area. The next day the bruise like rash became larger and darker.
Hives, starting 3.5 hours after administrating of Hepatitis A vaccine. No other explanation except vaccine allergic reaction.
syncope.  collapsed from sitting position.   emergency services called and arrived.  administered aid.  stabilized patient but he and wife refused further emergency services.  left on his own recognizance
Pt arrived to ED with 3 days of having fever and chills. She has a PMH of CVA and hypertension. Pt states that she was exposed to COVID on Monday. She was positive for COVID-19 and admitted for Remdesivir therapy/
Patient received vaccine Friday afternoon and was unmarked until Sunday morning and then noticed a swollen, red, warm mark about 4x6 inches in size around the injection site and she stated it was itchy.
After receiving my 4th dose, I experienced sudden hearing loss on 12/24/2022 in the afternoon. I felt like my right  ear was plugged. I did a virtual visit with my doctor who prescribe me Prednisone and advised me to take cold medications.  On 12/30/2022 I went to the urgent care where they said I might have fluids in my right ear. They prescribe me Antibiotics and advised me that I should visit an ENT. I got the ENT appointment on 02/17/2023 instead of March because It hasn't gone any better. They gave me 4 different Steroids' shots in 4 different intervals. I had 1 follow-up appointments after all 4 shots and I had no improvements. I will be having this hearing loss for rest of my life. I will also be going to get an hearing aid on 04/28/2023.
rash at the site of the injection; rash appeared behind her ear/had a rash as well but this year it was worse; Initial information was received on 02-Mar-2021 regarding an unsolicited valid non-serious case was received from an Other Health Care Professional via Agency (Reference number- 00500850) and transmitted to Sanofi on 02-Mar-2021.  This case involves a female patient who experienced rash at the site of the injection (injection site rash) and rash appeared behind her ear/had a rash as well but this year it was worse (rash), while she received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On an unknown date, the patient received dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [lot number not reported and expiry date not provided] via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious rash at the site of the injection (injection site rash) and rash appeared behind her ear/had a rash as well but this year it was worse (rash) (unknown latency) following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  Details of laboratory data were not reported.  She took an anti-itch medicine Benadryl.  On an unknown date, patient had recovered from the events.  There will be no information available on batch number for this case.
101 Fever; Chills all over; Severe muscle pain; Nausea; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 12Apr2021 at 12:45 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. The patient had no known allergies to medications, food or other products. Concomitant medications included levothyroxine sodium (SYNTHROID) from unknown date for unknown indication. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 13Apr2021at 03:00, the patient experienced 101 fever (units unspecified), chills all over, severe muscle pain and nausea. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. The clinical outcomes of 101 fever (units unspecified), chills all over, severe muscle pain and nausea were recovered on unknown date in Apr2021.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
pt exp cold like sx, had trouble swallowing; 7NOV devel stomach virus, explosive diarrhea; stomach rolled 8NOV; felt very tired, wanted to rest, lost of mucus; dx-MI, severe hardening of arteries, hypertension;
G-Tube was placed; This case was reported by a physician via call center representative and described the occurrence of gastrostomy tube insertion in a 6-month-old female patient who received Rota (Rotarix lyophilized formulation) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   On 7th January 2022, the patient received the 1st dose of Rotarix lyophilized formulation (oral) and Rotarix Oral Applicator Device. On an unknown date, less than 4 months after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator Device, the patient experienced gastrostomy tube insertion. On an unknown date, the outcome of the gastrostomy tube insertion was unknown.   The reporter considered the gastrostomy tube insertion to be unrelated to Rotarix lyophilized formulation and Rotarix Oral Applicator Device. 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: 6-May-2022 Reporter's comments: The patient received Rotarix orally at 2 months age. The gastrostomy tube was placed a couple of months before the date of reporting. The reporter stated that the placement of the gastrostomy tube was not related to the prior administration of Rotarix. Consented to follow up was given via postal. No lot number or expiry date available. No additional information was available at the time of the call.
3min generalized sz w/temp of 102.2 approx 4-5hr p/vax;fever lasted few hr next day;afeb, nl;
THE SHOT WAS GIVEN 05/06/22.. BUT ON 6/28/23 WE WERE NOTIFIED THAT THE EXPIRATION DATE OF THE VACCINE REPORTED TO BE GIVEN WAS 4/17/22??  THE PHARMACY HAS NO WAY TO PROVE THAT THIS WAS OR WAS NOT CORRECT SINCE IT HAPPENED 1 AND 1/2 YEARS AGO
mom reported on 9/24/2020 that baby had decreased bottle intake on 9/24/2020 and left leg "twitching" per mom's observation.  MD spoke with mom on 9/25/2020 and baby was doing well.  Eating was back to normal.
Pain, erythema, warmth, swelling at injection site in left arm just below where Shingrix was given measuring 30mm in diameter. Motrin 400mg TID taken. Generalized malaise and myalgias.
This spontaneous report as received from a 80 years old male patient regarding himself. The patient was allergic to penicillin. There was no pertinent medical history. On 07-Nov-2012, the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiration date and route not reported) 1 time injection on the left arm. Dose number was unspecified. Route, dose and lot number were unspecified. Concomitant medications included losartan potassium 50 milligrams (mg), LIPITOR 40 mg and aspirin 81 mg (reported as baby Aspirin). On 16-NOV-2012, the patient experienced tingling sensation on his fingers (in between his fingers) and on his palm, had blisters in the inside of both hands, also had small goosebumps or discolouration of the skin where his elbow bends. The patient sought no medical attention and no treatment was provided. The outcome of all the reported events were unknown. Additional information has been requested.
PATIENT REPORTS NUMBNESS AND TINGLING OF UPPER LEFT ARM APPROX 7 DAYS AFTER RECEIVING THEIR 1ST BOOSTER DOSE OF COVID 19 PFIZER. PATIENT RECEIVED PFIZER FOR ALL PREVIOUS DOSES AS WELL.
Child received rabies vaccines on 10/6/09 (at hospital) and on 10/9/09, 10/13/09 and 10/20/09 (health dept). He reported headache; itchiness on head, wrists, and ankles (no rash); bursts of anger 1 1/2 hours after receiving vaccine. Parent report child had mood swings and was jittery. Symptoms resolved 36 hours after receiving vaccines.
Vertigo; Dizziness; Low grade fever; This spontaneous case was reported by a patient and describes the occurrence of VERTIGO (Vertigo), DIZZINESS (Dizziness) and PYREXIA (Low grade fever) in a 66-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     Concurrent medical conditions included Sulfonamide allergy and Allergy to antibiotic (Macrolide). Concomitant products included ATENOLOL, IBUPROFEN (ADVIL [IBUPROFEN]) and OXYCODONE HYDROCHLORIDE, OXYCODONE TEREPHTHALATE, PARACETAMOL (PERCOCET [OXYCODONE HYDROCHLORIDE;OXYCODONE TEREPHTHALATE;PARACETAMOL]) for an unknown indication.    On 01-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 01-Nov-2022, the patient experienced VERTIGO (Vertigo), DIZZINESS (Dizziness) and PYREXIA (Low grade fever). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VERTIGO (Vertigo), DIZZINESS (Dizziness) and PYREXIA (Low grade fever) outcome was unknown.            Patient did not have COVID-19 Positive test. Concomitant product included protonic for an unknown indication.
Rash developed 10/27/11. All over body (+) itching. Evaluated by Dr. on 10/28/11. Diagnosis urticaria. Rec'd influenza on 10/25/11.
Patient has developed soreness to the arm since he got the shot on 11/11/11 which is not going away.
Developed abd cramping x 1 day - relieved with tums. Then fever to 103, fatigue, rash on bottom. No Rx Tx: symptomatic treatment.
Thankfully my reaction was not serious. Aside from a  sore arm, the next day I experienced body aches and chills starting around 9 a.m. By about 2 p.m. the body aches were getting better. By around 5 p.m..I was feeling better but was extremely tired. Woke up the next morn feeling good until around 10 a.m I .started getting a headache. Nothing unbearable but I don't get them often. Also had chills again. It is now 2;11 p.m and I am feeling better except for being tired. I am not concerned about the reaction I assume is from the vaccine but wanted to mention it to you. Thank you
pt recvd vax 19OCt93 devel pain, redness & swelling in the outer aspect arm;
Severe headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Severe headache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high and Diabetes.    On 19-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021, the patient experienced HEADACHE (Severe headache). At the time of the report, HEADACHE (Severe headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Mar-2021, Blood pressure measurement: 140/90 (High) elevated over 140/90 and high (High) risen to greater than 160/95.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications provided included blood pressure medications and diabetic medications.  No treatment medications were reported.
Information has been received from a 61 year old female patient. The patient's medical history included sore arm in 1993, 1994 and 1995. In 2008, the patient was vaccinated with the first dose of PNEUMOVAX23 (dose, route and lot number were not provided). In 2012, the patient was vaccinated with the second dose of PNEUMOVAX23 (dose, route and lot number were not provided) less than 5 years later. Concomitantly, the patient annually has been administered with FLUVIRIN (manufacturer unknown) (dose, route and lot number were not provided). In 2012, on the same day she received PNEUMOVAX23, her right arm and right leg were numb, felt like they were asleep, could not feel them and could not move them by herself. Nurse described these symptoms as her right arm and leg were paralyzed. All of these events resolved within 6 hours without any treatment. Upon internal review the adverse event of right arm and leg were paralyzed was considered to be medically significant. This is one of several reports from the same patient. Additional information has been requested.
incredible fatigue, chills, bright red rash on the entire upper body, headache, join pain,
side effects; This case was reported by a consumer via interactive digital media and described the occurrence of adverse drug reaction in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included fluticasone furoate, umeclidinium bromide, vilanterol trifenatate (Trelegy Ellipta).   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix and an unknown time after starting Trelegy Ellipta, the patient experienced adverse drug reaction. On an unknown date, the outcome of the adverse drug reaction was unknown.   It was unknown if the reporter considered the adverse drug reaction to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patent was asking that, how long the side effects of shingles vaccine last.
This spontaneous report as received from a Registered Nurse refers to two patients of unknown age. On 28-JAN-2014 those two patients were vaccinated with a dose of PNEUMOVAX23 (lot # J006921, expiration date 09-AUG-2014, dose not reported, intramuscularly). On an unkonwn date in 2014 after vaccination, both patients developed cellulitis at the site of PNEUMOVAX23 injection. The patients sought medical attention via going to see a physician. The present status of both patients was unspecified. Additional information has been requested.