chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pain on the arm; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. This consumer reported similar events for two patients (herself and her husband). This is the first of two reports.  A 56-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported), via an unspecified route of administration on 22Mar2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced pain on the arm in Mar2021.  The patient was referred to a healthcare professional for treatment. The outcome of the event was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021324105 same reporter/drug, different patient/events
n,v, h/a, chills woke up w/sx 13hr p/vax;took APAP;resolved in 6hr;
patient was administered 0.3 mL monovalent Pfizer instead of intended 0.3 mL bivalent Pfizer booster
I generally (for many years) have 5 day menstrual cycles.  Since my vaccine, my periods have lasted 8-9 days with heavier cramping and side effects.   The periods have also been heavier.  I also am experiencing acne since my vaccination.  The acne is appearing in unusual places on my face and with greater severity (large knots). I generally have clear skin.
syncope; seizures; POTS; autonomic dysfunction; orthostatic intolerance; dizziness; headache; fatigue; This spontaneous report was received from a lawyer regarding a case in litigation concerning an 18-year-old female patient (pt). Information on the pt's concurrent conditions, medical history or concomitant therapy was not reported. On an unknown date, the pt was vaccinated with Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) (dose, route of administration, lot# and expiration date were not reported) for prophylaxis. Following vaccination, in 2011, the pt experienced Postural orthostatic tachycardia syndrome (POTS), syncope, autonomic dysfunction, orthostatic intolerance, seizures, dizziness, headache, and fatigue. The outcome of all the events was not provided. The reporter stated that the events were deemed or should had been deemed causally related to Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) vaccination. This is one of multiple cases from the same reporter.  Upon internal review, Syncope and seizures were considered medically significant events.; Sender's Comments:  US-009507513-2301USA006946:
Feeling of tightness in the throat and like a lump and acid reflux not getting better  IM Benadryl felt better immediately  OBS  vs 99% HR 116 BP 115/73
At the time of injection, I had a mild to moderate pain on my injection site. Three hours after, it was more like moderate to severe pain on my arm. Then 5 hours later, I could see some swelling on my arm as well as SEVERE pain from the injection site. I tried to sleep through it, as I was sleeping around 2-3am on Dec.29th, I started to have symptoms like feeling feverish, chills, muscle/bodyache, intermittent diaphoresis, nausea, etc. I just remember feeling very uncomfortable and waking up a lot throughout the night. I had a SEVERE fatigue, headache, significant nausea as well as loss of appetite. I slept almost 20 hours which never happens. I took Tylenol around 4pm on Dec. 29th, and got my temperature taken and it was 99.5F. I slept again for another 14 hours (woke up once to take Tylenol again), and when I woke up today, I still had and still having moderate pain on my arm, shoulder & neck pain, muscle ache, headache, significant Nausea and loss of appetite. I just feel sick, very irritated, and not myself right now.
I started out with a horse voice and the next day I had watery eyes, runny nose, and a cough. I then tested for COVID-19 and it was positive then I went to a Urgent Care Clinic and it was positive as well.  I was given the antiviral PO4 Cough, and they both helped and within 4 days I had recovered. I do think it was a very mild case.
Sore arm at injection site. Cold compress applied for 5 minutes. Felt better after that. Returned to work within 15 minutes.
hadn't received the third dose of the series yet; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 64-year-old female patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (1st dose received in 18th April 2020) and Twinrix (2nd dose received on an unknown date).   On an unknown date, the patient did not receive the 3rd dose of Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced incomplete course of vaccination (Verbatim: hadn't received the third dose of the series yet). The outcome of the incomplete course of vaccination was 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: 01-JUN-2023 A pharmacist informed that a patient that started the scheme of Twinrix back in April 2020 had not received the third dose of the series yet. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up. Till the time of reporting, the patient did not receive 3rd dose of Twinrix, which led to incomplete course of vaccination. Details pertains to 1st and 2nd dose of Twinrix in product tab.
This is a spontaneous report from a non-contactable pharmacist who reported on behalf of the patient. This female patient of an unspecified age and race received PREVNAR 13 on 10Jan2017, at 0.5 ml single, in the arm, for immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported.   Since an unspecified date in Jan2017, arm where pharmacist did give the vaccine was red, blown up and warm, started to flare up and got hot and obnoxious (so the patient took a cold compress), she could not sleep and she felt dizzy. The patient thought she was passing out in the morning (so she was all night long). When she put a cold compress, it heated, all in there was red and she called the pharmacist and told her about it. The patient did not know what to do, whether it was infected because it was very hot and she put on the compress which would let her get out and drive the car because she was afraid of driving. She felt so dizzy so it was going to be some sort of infection there probably. Events outcome was unknown at the time of report. No follow-up attempts possible. No further information expected.
Significant increase in tinnitus, continuous since shortly after injection.  This is consistent with symptoms experienced after COVID infection in February 2020, Pfizer vaccine #1 (3/17/21), Pfizer vaccine #2 (4/7/21).  Between Pfizer #2 and Moderna Booster, tinnitus finally seemed to begin improving after roughly 6 months.  Following Moderna #3, symptoms have returned to a similar level experienced previously.
11/1/18 note: Pt c/o nausea w/o vomiting, malaise, and mild HA (3-410) one day after receiving flu immunization.
Client called office on 12/12/08 to report she had developed hives on 12/9/08.  Denied any respiratory difficulty or other symptoms.  Recommended she seek medical care.  Called client on 12/17/08.  She did not seek medical care and stated the hives resolved without any treatment.
Received annual flu vaccine approx 10:00 am. (L) deltoid. Approx 1-1 1/2 hours later, c/o itching to back (low back) and (R) side abdomen. Also c/o tongue "itching". No s/s angioedema. No wheezing. Areas with itching with small raised areas, hive in appearance. Self administered an OTC 25 mg Benadryl. Hives disappeared approx 20 mins after Benadryl. Low back and (R) abd less reddened. C/o itching to those areas also lessened.
I did not have an adverse reaction to the vaccine. I tested positive for COVID-19 on 06/21/2022. I started feeling symptoms on 06/20/2022 with a sore/scratchy throat, headache, diarrhea, fever and felt like I was hit by a bus. I was prescribed something at the urgent care center but I don't remember what it was.
Since the day of the shot I haven't been able to sleep so I got my shot Sunday and Sunday night I had a fever of 101.0 them Monday morning I couldn't get out of bed my body aches and headaches Wednesday I went to urgent care they didn't do anything because they said they cant treat it I had a several headache like if my head was going to explode and since then I have been having headaches and arm pain the back of my head hurts a lot I cant stand it no more it fill like if something sharp of hitting my head.
3AM woke up with fever (~12 hours), severe body aches (lasted ~12 hours) and severe shaking. Patient states she was unable to move her arms, hands, legs and mouth  or speak for 5-8 minutes after waking up.
pt recvd vax & w/in 8hrs post vax exp nausea & vomiting;sx persist
Generalized tonic-clonic movement of his extremities for about 15 minutes.  Taken to ER, observed and then discharged.
Injection site was itchy; Injection site was swollen; Injection site was red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Injection site was itchy), VACCINATION SITE SWELLING (Injection site was swollen) and VACCINATION SITE ERYTHEMA (Injection site was red) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Injection site was itchy), VACCINATION SITE SWELLING (Injection site was swollen) and VACCINATION SITE ERYTHEMA (Injection site was red). At the time of the report, VACCINATION SITE PRURITUS (Injection site was itchy), VACCINATION SITE SWELLING (Injection site was swollen) and VACCINATION SITE ERYTHEMA (Injection site was red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Treatment for the events included none. No consultation with Healthcare professional done.  Based on the current available information and temporal association between the use of the product and the start date of the events ,a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events ,a causal relationship cannot be excluded.
pt exp lower back pain & stiffness in hips & buttocks;devel pain both upper arms & shoulders;AUG became more stiff & sore, almost to the point of being bed-ridden;seen by MD 19AUG96 dx lower back problems;18SEP96 dx polymyalgia rheumatica
7 hrs after receiving MMR in (R) arm, reports severe itching, redness and hives on chest. Took BENADRYL 50 mg po x CLARITIN 20 mg this am. Then in notes remain rash on chest and redness surrounding injection site.
devel swollen lymph nodes behind ears & across neck during wk  16JUL97;19JUL97 lymph nodes more swollen & sore;20JUL97 devel fever 101, chills, aching, fatigue & very swollen sore lymph nodes in neck & behind ears;slept a lot;seen by MD;
felt bad; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt bad) and FATIGUE (fatigue) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In June 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (felt bad) and FATIGUE (fatigue). At the time of the report, FEELING ABNORMAL (felt bad) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant products information was not provided. Treatment information was provided.   This case was linked to MOD-2021-285588 (Patient Link).
patient accidentally given Moderna shot even though she was only 17yo.  Patient did get light headed and dizzy for about 15 minutes after injection.
Rheumatoid arthritis flare up; This is a spontaneous report from contactable nurses. A 38-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date (at 38 years old) as single dose for COVID-19 immunization. Medical history was not reported. Concomitant medications included methotrexate; fluticasone propionate (FLONASE ALLERGY RELIEF); VITAMIN D (reported as VITAMIN D-400) taken for an unspecified indication, and an unspecified multivitamin capsule. The patient previously took tofacitinib citrate (XELJANZ) and was on hold for about one month due to eye infection from which she took antibiotics. The patient stated she received her first COVID vaccine before restarting tofacitinib citrate. She is currently having a rheumatoid arthritis flare up in Mar2021. The physician (MD) is aware. The outcome of the event was not resolved.   Information about lot/batch number has been requested.; Sender's Comments: Based on temporal relation, the assosciation between BNT162B2 vaccine and rheumatoid arthritis flare up cannot be completely ruled out.The impact of this report on 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 committees, and Investigators, as appropriate.
The patient was given 0.2 ML's of the gray cap formulation instead of 0.2 ML's of the orange cap formulation. After talking with the patient's guardian today, the guardian stated the patient only had a mild headache the day of (8/9/23). I advised the guardian to keep an eye on the patient and I watch out for any alarming side effects. I also let them know that as of now that this shot still counts as the patient's full series.
She received and the third gave her energy.; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (She received and the third gave her energy.) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 035C21A, 013L20A and 016M20A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetic, Blood pressure high and Thyroid disorder. Concomitant products included OLMESARTAN MEDOXOMIL for Blood pressure high, METFORMIN for Diabetes, LEVOTHYROXINE for Thyroid disorder.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (She received and the third gave her energy.). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (She received and the third gave her energy.) outcome was unknown.            No treatment medication was  reported.   This case was linked to MOD-2021-335075 (Patient Link).
Hot to the touch; Area around upper arm and shoulder muscle where injection is swollen; Rash around the injection site; Black and blue right at the injection site; Mild soreness in the arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Hot to the touch), VACCINATION SITE DISCOLOURATION (Black and blue right at the injection site), VACCINATION SITE SWELLING (Area around upper arm and shoulder muscle where injection is swollen), VACCINATION SITE RASH (Rash around the injection site) and VACCINATION SITE PAIN (Mild soreness in the arm) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2021, the patient experienced VACCINATION SITE PAIN (Mild soreness in the arm). On 13-Jan-2021, the patient experienced VACCINATION SITE DISCOLOURATION (Black and blue right at the injection site) and VACCINATION SITE RASH (Rash around the injection site). On 14-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Hot to the touch) and VACCINATION SITE SWELLING (Area around upper arm and shoulder muscle where injection is swollen). At the time of the report, VACCINATION SITE WARMTH (Hot to the touch), VACCINATION SITE DISCOLOURATION (Black and blue right at the injection site), VACCINATION SITE SWELLING (Area around upper arm and shoulder muscle where injection is swollen), VACCINATION SITE RASH (Rash around the injection site) and VACCINATION SITE PAIN (Mild soreness in the arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant medication was not reported.  Treatment medication was not reported.    Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Information has been received from a nurse concerning a 15 year old male patient who on an unspecified date was vaccinated with the second dose of GARDASIL (lot #, expire date and route not reported). Nurse reported that on an unspecified date after receiving the second dose of GARDASIL, the patient experienced fainting while in the office, a second fainting spell the following day, and a third fainting spell later at an unspecified time. The dates of both the first and second dose of GARDASIL were not available. At the time of report, patient's outcome was unknown. Follow-up information was received from the nurse, concerning the patient, with no illness at the time of vaccination, and no pre-existing allergies, birth defects or medical conditions, who on 27-JAN-2011 was vaccinated intramuscularly in the left arm with the second dose of GARDASIL (lot number 666931/0337Z) at pm. It was reported that the patient had a vasal vagal event in the office after administration of vaccine and that the following day fainted in a store and then fainted a third tome at optometrist office. The patient recovered on 28-JAN-2011. No further information is expected.
The joints in my hands and feet  keep swelling. They ache horribly. Nothing really helps.
After thee days of vaccination, experiencing severe tinnitus in both ears. Has not gone away as of today, 4/14/21. never had ringing in her ears in her life. We are very worried this will be permanent.
3 times in 20 mins period pt turned white, eyes rolled back stopped breathing x 15-20 seconds; resp resumed when mom blew in face;
Extreme soreness to injection site, Flu-like symptoms including nausea, headache, fatigue, body aches, chills (during the evening), and mild diarrhea. Most symptoms were better by 6 PM on 1/9/2021. Diarrhea better by 1 PM 1/10/2021.  (I had NONE of these after the first  vaccination.)
Pt requested to have Pfizer Booster/Bivalent #4 in series, along with TDaP and Flu Vaccines. Pt was given Pedi Pfizer 5-11yo dose, undiluted. AE noted when counting left over/wasted vaccine. Pfizer was call for advise r/t what treatments  or steps should be taken for Pt's health concerns. Pfizer reported, " Pedi dose(5-11yo) undiluted, is the same dose as 12 and up dosage. No, further action should be taken
The patient received his H1N1 shot in the left arm, 3-4 inches below tip of the shoulder. There was soreness at the injection site but no swelling. 4 days later, he experienced tingling in his hand on the left side, alternately on the median and lateral sides, with no specific fingers involved. He also experienced fatigue, malaise, fever, chills, sore throat, nasal congestion, headache, and weakness. The symptoms gradually subsided over 3-4 days. He had a similar experience with the tetanus vaccine previously, but with no other vaccines. He has no chronic medical problems.
After 2 days of getting the injection, experiencing numbing  and tingling in the left and right hand and arm. Causing sleepless nights. After a week, numbing  in right side neck, cheek, and ear. Symptoms still continue through today.
Rash on top of head (scalp) and on lateral portion of his ankles. Described as hives, small, red, raised, no drainage, pruritus only to scalp.
Extreme fatigue; joint pain; headache; fever of 103.4; increased blood pressure (138x 89); vivid dreams; This is a spontaneous report from a contactable consumer or other non hcp.  A 43-years-old male patient received bnt162b2 (BNT162B2 PFIZER BIOTECH MRNA COVID 19 SOLUTION FOR INJECTION (Batch/Lot Number: FF8841), dose 3 intramuscularly, administered in Arm Right on 03Nov2021 10:15 as dose 3 (booster), single for covid-19 immunisation. Medical history included hypertension. Concomitant medication(s) included influenza vaccine (FLU) taken for an unspecified indication from 04Oct2021 to 04Oct2021; lisinopril (LISINOPRIL). The patient previously took bnt162b2 for covid-19 immunisation, bnt162b2 for covid-19 immunisation, carbamazepine and experienced hypersensitivity. The patient had not received any other vaccine within 4 weeks, Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. It was reported that, the patient experienced extreme fatigue, joint pain, headache, fever of 103.4, increased blood pressure, vivid dreams   on 03Nov2021 18:00 with outcome of recovering. The patient underwent lab tests and procedures which included blood pressure measurement: 138x89 on 03Nov2021, body temperature: 103.4 on 03Nov2021.  Therapeutic measures were taken advil 600 mg as a result of extreme fatigue (fatigue), joint pain (arthralgia), headache (headache), fever of 103.4 (pyrexia), increased blood pressure (138x 89) (blood pressure increased),vivid dreams (abnormal dreams).Case was assessed as non-serious and patient was not hospitalized. Follow-Up (09Nov2021): Follow-up attempts are completed. No further information is expected.
This spontaneous report was received from an unknown age, male consumer, reporting on himself. Medical history and concurrent conditions were not reported. On 10-OCT-2014 the patient was vaccinated with the first dose of RECOMBIVAX HB 10 mcg/ml, lot #K006682, expiration date 17-DEC-2015, (dosage and route were not provided), subsequently on 07-NOV-2014, he received the second dose of RECOMBIVAX HB lot# J013394, (dosage and route were not provided), and on 10-MAY-2015, he received the third dose of RECOMBIVAX HB lot # K010535, expiration date not reported, (dosage and route were not provided). The patient reported that on an unknown date in approximately 2015, he experienced an Anti-HBs antibody negative, reported as "his immune system did not respond to the vaccination". It was unknown if the patient sought medical attention. The outcome of the Anti-HBs antibody negative was unknown at the time of this report. No product quality complaint was involved. Additional information has been requested.