chrisvoncsefalvay/vaers-outcomes huggingface dataset:
lost muscle capacity of her arm/cannot lift a gallon of milk in the fridge/Right arm lost muscle capacity; headache; terrible pain in her right elbow; joint discomfort; feeling achy in her right arm and all over; feeling achy in her right arm and all over; This is a spontaneous report from a contactable consumer.  A 63-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number EL1284), via an unspecified route of administration on 06Jan2021 14:30 at single dose for covid-19 immunisation.  Medical history included hypothyroidism, cholesterol. Concomitant medication included levothyroxine, atorvastatin.  Patient on the line calling about the COVID 19 Vaccine on Wednesday in her right arm. Her right arm lost muscle capacity, she cannot lift, she cannot even lift a gallon of milk in the fridge. This has improved, but she still cannot use it normally. Thursday she was feeling achy; Friday she had a headache. Later that day she had the most terrible pain in her right elbow. It was excruciating pain. The next morning pain subsided. However, she does not have her full arm strength back yet. She confirmed she is a HCP. She also added, she works at the hospital. It is like a centralized monitoring system where she watches monitors connected to the care unit and since she has background as a HCP she alerts the nurses when there is an issue. She clarified her right arm lost muscle capacity was noticed on Friday 08Jan2021. She got the vaccine on 06Jan2021 and was able to drive home and it was fine. The next day, 07Jan2021 she was achy, like flu like, with joint discomfort that she normally does not have even though she is getting older. She was feeling achy in her right arm and all over. The achiness all over resolved Thursday or Friday. She confirmed she has recovered completely. On Friday 08Jan2021 she had a headache that would just not go away. The headache was not in the front, back, or above eyes so she knows it was not sinuses. The headache lasted all day. Stated by the next morning the headache was gone. Her head is fine. She confirmed she has recovered completely. She later added, even though she is getting older and forgets things. No additional details provided. She was supposed to go to work on Friday, but she was not quite miserable, but she just could not bring herself to go into work. She called out because of the headache and the arm pain had started to kick in. The outcome of the event Muscle weakness upper limb was resolving, joint discomfort was unknown, while the outcome of the other events was resolved in Jan2021.
Shot was given to me very high on my left arm. I was very sore where the shot was given. My arm and shoulder are in constant pain it is hard to lift with left arm.
Severe back and neck pain, fever, kidney pain, little-to-mild itching all over body, small amount of hives.
Information has been received from a registered nurse and a certified pediatric nurse practitioner concerning a 4 year old male who on 3/6/01 was vaccinated with a dose of varicella virus vaccine live. It was also reported that the patient received a dose of MMR, a dose of pneumococcal 4 6B 9V 14 18C 19F 23F conjugate vaccine, and a third dose of poliovirus vaccine inactivated. It was noted that the patient received the first and second dose of poliovirus vaccine inactivated on 2/24/00 and 5/3/00. On 10/23/04, the patient developed less than 50 varicella lesions and he was seen by the nurse practitioner on 10/25/04. She noted the patient to have a runny nose-clear with a normal medical exam except for the less than 50 papular red spots along his neck (some beginning to scab) and she diagnosed him with varicella. No treatment was ordered. At the time of the report, the patient had recovered. There was no product quality complaint. Additional information is not expected.
patient experienced sore throat, fatigue, coughing sneezing, runny nose for 2.5 weeks starting 24 hours after receiving immunization, patient experienced syncopal episode 3 weeks after immunization on 04/29/2021, but patient also reported being in the shower at time of incident.
Report A0378692A describes joint pain in a 29 year old male who was vaccinated with Lyme disease vaccine recombinant OspA (LYMErix) for prophylaxis. The subject's medical history, concurrent conditions, and concurrent medications were unknown. On 5/19/99, 6/18/99 and 8/1/00, the subject received his first , second, and third injections of LYMErix, respectively. The lots used were LY116B2, and LY128A2. Subsequent to his third injection of LYMErix, on an unspecified date, the subject began to experience joint pain. He was seen by a physician. As of 8/20/02, the event was ongoing. The adverse event "joint pain" does not meet serious criteria, but is being submitted as an expedited report by special FDA request per the 6/28/00 letter.
This spontaneous report as received from a nurse midwife refers to a female patient of unknown age. The patient had no medical history, concurrent conditions and concomitant medications. On an unknown date, more than 10 years ago, the patient was vaccinated with GARDASIL injection for recommended vaccination (dose, lot # and expiration date were not reported). It was reported that the patient completed the "HPV series". On an unknown date, the patient tested positive for cervical low grade squamous intraepithelial lesion (LGSIL). The nurse reported that the patient did not have cancer. The outcome of the event was unknown. The causality assessment was not reported.
After shot got dizzy had sortness of breath tightness in chest throat tight and numbness and tingling in lower lip..at onset of symptoms took benedryl and after about one hour symptoms started to alleviate
No adverse events listed however patient was exposed and tested positive for COVID-19   03/31/21 1236  COVID-19 External (Lab)  Collected: 03/28/21 0000 | Edited Result - FINAL | Specimen: Swab from Nares   COVID-19 Overall Result External DetectedAbnormal
This spontaneous retrospective pregnancy case was reported by a physician and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (conceived within days after receiving the second dose, probably 2 or 3 days after the second/had a healthy baby on 27October2021/conceived right away on her first try and had no complications) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025J20A, 013L20A and 061E21A) for COVID-19 vaccination. The patient's past medical history included Miscarriage from December 2019 to December 2020.On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form.On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 01-Nov-2021. On 13-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (conceived within days after receiving the second dose, probably 2 or 3 days after the second/had a healthy baby on 27October2021/conceived right away on her first try and had no complications). The delivery occurred  on 27-Oct-2021, which was reported as Full-term.For neonate 1, The outcome was reported as Delivered NOS. She gave birth on 27-Oct-2021, 5 days early, full term. At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (conceived within days after receiving the second dose, probably 2 or 3 days after the second/had a healthy baby on 27October2021/conceived right away on her first try and had no complications) had resolved.    For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.No concomitant and treatment medication were provided. Patient's last menstrual period was on 25January2021.Company comment: This is a case of Maternal Exposure during Pregnancy concerns a 38-year-old female patient with no relevant medical history, who experienced no other associated adverse events. The patient was exposed to the second dose of mRNA-1273 Vaccine during her pregnancy at an unknown age of gestation. The benefit-risk relationship of mRNA-1273 Vaccine in not affected by this report. Sender's Comments: This is a case of Maternal Exposure during Pregnancy concerns a 38-year-old female patient with no relevant medical history, who experienced no other associated adverse events. The patient was exposed to the second dose of mRNA-1273 Vaccine during her pregnancy at an unknown age of gestation. The benefit-risk relationship of mRNA-1273 Vaccine in not affected by this report.
Patient says her arm was extremely sore.  She feels like the muscle is torn.  She thinks she may have loss of motion and drops things easily.
Max pain of L arm with movement, hot to the touch, rash at injection site with high sensitivity to touch.
This spontaneous report was received from a nurse, who is also the patient: a female of unknown age. No information about the patient's medical history, concurrent conditions and concomitant medications was reported. On 10-JUL-2018, during the process of withdrawing VARIVAX (lot # N034553, expiry date: 05-DEC-2019, for prophylaxis) from vial into syringe, it just sprayed like an aerosol can all over the nurse's hands, arms and the counter top, and very little liquid went into the syringe. There was no adverse event reported. Product quality complaint was involved.
A nurse reported that a 33 year old male received an injection of TD Adsorbed, Purogenated on 8/21/00. On 8/23/00, he developed an injection site reaction characterized by "extreme" pain, soreness, swelling and redness. The pt recovered. This is 1 of 4 patients from this facility who had an adverse experience following receipt of this vaccine, lot 471038.
Approximately 7 hours after receiving the second dose of COVID-19 vaccine, reporter noted lightheadedness, dizziness, mild intermittent aches and neck pain.  Approximately 12-13 hours post dose, reporter developed serious systemic aches and pains, uncontrollable shaking, chills, nausea, vomiting, and developed a fever of up to 103.1.   These more severe symptoms lasted approximately 3 hours and were treated with acetaminophen and ibuprofen only.
a patient received the Fluzone Quadrivalent 0.25 mL for their first dose and second dose 0.5 ml / no AE; Initial information received on 22-Nov-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 3 years and 10 months old female patient who was vaccinated with 0.25 ml first dose of suspect INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] lot UT6647JA (Expiry date 30-Jun-2020) via intramuscular route in the thigh nos on 14-Oct-2019 and 0.5 ml second dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UJ2578C (Expiry date 30-Jun-2020) via intramuscular route in the thigh nos on 11-Nov-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error case due to vaccine underdose.  At the time of reporting no adverse reaction 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 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.
I noticed but didn?t correlate until after my second dose. The first menstrual cycle after dose was extremely painful, cramping I never experienced before light headed and lasted several hours . Resolved with 800 mg ibuprofen and 1000mg acetaminophen. My cycle after dose two was similar but a bit less severe.
From 11:00 PM on 03/31/2021 until 8:00 AM on 04/02/2021 - Fever of 102 uncontrolled by around the clock acetaminophen, severe fatigue and lethargy, nausea, and headache, chills, lack of appetite
stomach pain/stomach has been killing me; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (stomach pain/stomach has been killing me) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ABDOMINAL PAIN UPPER (stomach pain/stomach has been killing me). At the time of the report, ABDOMINAL PAIN UPPER (stomach pain/stomach has been killing me) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.  No treatment medications were provided.   Reporter did not allow further contact
5 MINUTES AFTER PTS FIRST COVID VACCINE, SHE STARTED EXPERIENCING CHEST PAIN AND BURNING.  PULSE SEEMED NORMAL AS WELL AS BLOOD PRESSURE, BUT THE PAIN WHIC WAS 5 ON A SCALE OF 10 WAS NOT GOING AWAY.  EMS WAS CALLED AND SHE WAS TAKEN TO LOCAL HOSPITAL FOR TREATMENT
Diffuse pruritic rash/urticaria with subsequent ER evaluation and improvement after Benadryl, Zantac, solumedrol after rabies vaccination #2 on 11/3/2011. Pt experienced mild urticaria after RIG and rabies vaccination #1 on 10/31/2011. He self treated with Benadryl and rash resolved. (He did not report this first incident to any medical providers).
11:30 am developed bad stomach cramps/ nausea. Around 10:30 pm chills.  11:30 pm fever100.5, bad body aches, headache, nausea, slight periodic numbness in hands. Next day fever gone. On day 6 and still have bad stomach cramps. Some nausea and slight headache, scratchy throat.
Hive looking rash all over body and face; Hive looking rash all over body and face; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 5 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 13Jan2022 15:15 (Batch/Lot number: unknown) at the age of 5 years 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: URTICARIA (non-serious), RASH (non-serious) all with onset 14Jan2022 12:00, outcome "not recovered" and all described as "Hive looking rash all over body and face". Therapeutic measures were not taken as a result of urticaria, rash.  Additional information: The patient not received other vaccine in four weeks. The patient not had covid prior vaccination. The was not tested for covid post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Facial palsy on the right side began 6 days after receiving second dose of Covid (Pizer) vaccine. Sypmtoms start with a numb tongue and gradually moved up to the right eye. Tongue numb, smile not even, facial drooping, right eyelid nonfunctional, hearing affected. Prescribed 60mg Prednisone taken 1x daily for 7 days started on day 5 of reaction. Treatment still ongoing and symptoms still present on Day 6 of reaction.
Extreme Body aches, chills, fever, migraine, extreme sweating. After the first round my arm stayed swollen and itchy for 2 weeks. I no longer have a fever, but continue to sweat and wear out easily. I've had strange dreams as well.
2days after my 1st Covid vaccine I broke out into a rash with hives requiring me to go to the ER; 2days after my 1st Covid vaccine I broke out into a rash with hives requiring me to go to the ER; This is a spontaneous report from a contactable nurse (patient). A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number: EH9899, expiry date was not provided) solution for injection, via an unspecified route of administration on left arm on 17Dec2020 08:00 at a single dose for Covid-19 immunization. Medical history included eczema, chronic kidney disease, thyroid disease. Patient had known allergies. The patient was not pregnant. Concomitant medications included apixaban (ELIQUIS), allopurinol (ALLOPURINOL), levothyroxine (LEVOTHYROXINE), iron (IRON), magnesium (MAGNESIUM). The patient reported that 2 days after her 1st Covid vaccine, she broke out into a rash with hives requiring her to go to the ER on 19Dec2020 12:00. She also visited a physician. She was treated with steroids, Atarax, and Epi shot. The events were reported as non-serious. Outcome of the events was not recovered.   No follow-up activities are needed. No further information is expected.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of urticaria and rash due to temporal relationship.  There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics  and concomitant medications.   This case will be reassessed once additional information is available.  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.
Flu; Initial information was received on 17-Dec-2021 regarding an unsolicited valid non-serious case from a Social Media via a consumer/non-health care professional.  This case involves a patient (unknown demographics) who had flu (influenza) after receiving INFLUENZA VACCINE.  It was unknown if the patient had any medical history, concomitant disease or risk factor.  The patient's past medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiry not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "and so did I, yet a month later I got the flu!"  It was unknown if the patient experienced any additional symptoms/events.  It was unknown if there were lab data/results available.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, outcome of the event was unknown.  The reporter did not report the causality of event with suspect.  There will be no information available on the batch number for this case.
Patient felt light-headed and temporarily "passed out" 20 minutes after receiving the vaccine. Paramedics came and took vitals and they were all normal and they did not recommend any intervention or further treatment
pt recvd DTAP only on 29AUG94 & the following day, arm was squeezed @ inj site;1SEP arm was hurting w/a swollen red area (4cm x 5cm) & an irregular border;arm was hot to touch;could not raise arm laterally;No fever MD suspects cellulitis
Pt received the vaccine in the afternoon and the following day called our pharmacy complaining of red, puffy eyes and sensitivity to light.
Information has been received from a physician concerning a 14 year old female patient who on approximately 05-JAN-2007 was vaccinated at another physicians office with HPV vaccine (yeast) (lot # not provided). On an unspecified date in January 2007, the patient was seen by the reporting physician for a suspected urinary tract infection (lab results not provided). The patient sought unspecified medical attention. At the time of this report it was unknown if the patient had recovered from the event. Additional information has been requested.
Pt recvd vax 16JUL91, area 4.5" x 5.5", skin reddened, hot, firm & swollen w/reported sensitivity to touch; MD ordered ice packs, Motrin 600mg oral 3 times a day, recheck on 19JUL91 @ 130PM;
My symptoms occurred the following night of my first dose. Shortly after lying down I felt sharp chest pains as well as pains in my neck and shoulder area. Deep breaths were uncomfortable and my heart rate felt slightly elevated. I slowed down my physical activity a little as to not aggravate any symptoms. I assume it was a mild case of myocarditis that I slept off. I've felt fine since then but have not got the second dose yet.
having aches; they can not get a breath,run out of breath; joint pain; rapid health decline; got sick; never able to run with the same cardiovascular capacity; joint injuries; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (having aches), VACCINATION COMPLICATION (rapid health decline), ILLNESS (got sick), EXERCISE TOLERANCE DECREASED (never able to run with the same cardiovascular capacity) and JOINT INJURY (joint injuries) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Sickness (before getting the Moderna vaccine, patient was sick but did not get tested for covid.19).    On 11-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2021, the patient experienced VACCINATION COMPLICATION (rapid health decline), ILLNESS (got sick), EXERCISE TOLERANCE DECREASED (never able to run with the same cardiovascular capacity), JOINT INJURY (joint injuries) and ARTHRALGIA (joint pain). On an unknown date, the patient experienced PAIN (having aches) and DYSPNOEA (they can not get a breath,run out of breath). At the time of the report, PAIN (having aches) had not resolved and VACCINATION COMPLICATION (rapid health decline), ILLNESS (got sick), EXERCISE TOLERANCE DECREASED (never able to run with the same cardiovascular capacity), JOINT INJURY (joint injuries), DYSPNOEA (they can not get a breath,run out of breath) and ARTHRALGIA (joint pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2021, SARS-CoV-2 test: negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications was provided by the reporter.  No treatment medications was provided by the reporter.
Menstrual cycle started next morning, although it was not due for 1 week.  Very heavy bleeding & cramping
This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient. A 58 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 01Feb2021 12:00 (Lot number: EL3247) at the age of 58 years as dose 1, single for Covid-19 immunisation. Relevant medical history included: "Allergy: strawberries" (unspecified if ongoing), notes: Known allergies: Pan Strawberries; "Sulfonamide allergy" (unspecified if ongoing), notes: Known allergies: Sulfa. Concomitant medication(s) included: VITAMIN D [COLECALCIFEROL]. The following information was reported: MOUTH ULCERATION (non-serious) with onset 05Apr2021 17:00, outcome "not recovered", described as "red ulcers". Therapeutic measures were not taken as a result of mouth ulceration. Additional information: The patient had not received any other vaccine in four weeks. It was unknown if the patient had tested for Covid-19 prior vaccination. The patient had not tested for Covid-19 post vaccination. No follow-up attempts are possible. No further information is expected.