chrisvoncsefalvay/vaers-outcomes huggingface dataset:
constant tickling in her throat; ribs to hurt; sore throat; coughing; tremors; achy/body ached; cold/chills; fever of 103F; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL DISCOMFORT, MUSCULOSKELETAL CHEST PAIN, OROPHARYNGEAL PAIN, COUGH, and TREMOR in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B29A and 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Apr-2021, the patient experienced TREMOR, PAIN, CHILLS, and PYREXIA. On 03-Apr-2021, the patient experienced OROPHARYNGEAL PAIN and COUGH. On 05-Apr-2021, the patient experienced MUSCULOSKELETAL CHEST PAIN. On 06-Apr-2021, the patient experienced OROPHARYNGEAL DISCOMFORT. The patient was treated with ROBITUSSIN for Cough, at a dose of 1 dosage form and TYLENOL for Fever, at a dose of 1 dosage form. On 02-Apr-2021, TREMOR had resolved. On 03-Apr-2021, PAIN, CHILLS, and PYREXIA had resolved. At the time of the report, OROPHARYNGEAL DISCOMFORT, MUSCULOSKELETAL CHEST PAIN, OROPHARYNGEAL PAIN, and COUGH outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Apr-2021, Body temperature: 103 f (High). On an unknown date, Body temperature: 100 f (High).         Concomitant product information, if any, was not provided by the reporter.   This case was linked to MOD-2021-068400, MOD-2021-070272. Sender's Comments:  MOD-2021-068400: first dose case ID-MOD-2021-068400 MOD-2021-070272:mSecond dose case ID- MOD-2021-070272
About 1.5 days after receiving the vaccination a swollen, red, warm area started to appear on the arm where the shot was given. It covered about half of the outer upper arm. It was also tender to touch. Lasted 3.5 days. I took Benadryl as it was slightly itchy.
About 3 weeks after the 2nd dose vaccination,  at night my joints started to feel painful in my knees and elbows.  The pain would keep me up at night.   I took over the counter ibuprofen to help relieve the pain.  The pain was about an 8/10.  After a few days, I went to see my doctor.  The doctor did blood work and it came back positive for indicators for autoimmune disease.  I was prescribed a steroid Prednisone for 3 weeks  to alleviate the pain. I was referred to a rheumatologist for follow up. My appointment is in November 2021.  The pain is resolved and I was advised that it may flare up at any time in the future.
Rapid heart beat, nausea, headaches, fever, body aches, abdominal pain.
Rash/contact dermatitis on feet, lower legs,  belly. Improving with prescription cream and steriods.
patient was pregnant at time shot was given . She came in for her second dose and reported she had miscarriage
covid test was positive after both doses; covid test was positive after both doses; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EP7534) via an unspecified route of administration on 19Mar2021 as dose 1, single; and later received second dose of BNT162B2 (Lot number: ER8734) on 09Apr2021 as dose 2, single; both for covid-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that patient received the two parts of Pfizer vaccine on 19Mar2021 and 09Apr2021 and experienced a week of symptoms, losing taste and smell was the clincher in Jun2021. After that patient went to a local urgent care and had a nasal swab covid test that was positive on 05Jul2021. Patient was told that many vaccinated people were testing positive in his/her area. On 05Jul2021, the patient underwent lab tests and procedures which included sars-cov-2 test which result was positive. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
PLAQUE PSORIASIS BREAKTHROUGH FLARE ON ELBOWS AND UPPER RIGHT ARM; This spontaneous case was reported by a consumer and describes the occurrence of PSORIASIS (PLAQUE PSORIASIS BREAKTHROUGH FLARE ON ELBOWS AND UPPER RIGHT ARM) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    No Medical History information was reported.   On 01-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced PSORIASIS (PLAQUE PSORIASIS BREAKTHROUGH FLARE ON ELBOWS AND UPPER RIGHT ARM). At the time of the report, PSORIASIS (PLAQUE PSORIASIS BREAKTHROUGH FLARE ON ELBOWS AND UPPER RIGHT ARM) had not resolved.            No concomitant medications were reported. It was unknown whether patient was enrolled in a COVID-19 Vaccine Trial. The reporter causality for the event of Psoriasis flare-up was assessed as " Reasonable possibility" for cosuspect skyrizi. No treatment medications were reported. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   Reporter did not allow further contact
Got booster at 6 PM on 12/17/2021, no issues, ate dinner, slept fine, woke at 7 AM. After breakfast drank water and orange juice then 16 hours after booster around 9 AM on 12/18/2021 feeling fine, went and donate blood. Then about an hour later feeling tired, then headache, chills, then low grade fever, 99, then as ay went on fever peaked at 102 around 5PM, still had headache, chills, and some joint pain in knees and a sore throat. Arm hurt at injection site. Took Tylenol at 5 PM, fever broke around 8 PM, took more Tylenol at 11 PM. Three times during the night had to change clothes due to sweating. Got out of bed at 7 AM on 12/19/2021 still have headache, sore throat, knee pain and feeling fatigued and sluggish.
6 hours post vax, the pt had a episode in which she closed her eyes, tensed her hands and stiffened arms. No unresponsiveness, no color change, no limpness. Pt experienced 3-4 similar episodes and was seen in the office.
On Saturday-Sunday,  March 6-7 I had diarrhea, nausea, chills and body aches.  Beginning Wednesday, March 10 and continuing to the present, I have had an itchy rash over much of my body--arms, stomach, and back of legs.
I had aches, pains. I still have some lymph node swelling. These were not as serious as the main problem. Hours after the shot, I began to bleed heavily for approximately two weeks. Unusually, the flooding of blood involved both liquid, and large clots. The bleeding seemed nonstop during week one, I had an very heavy clot halfway through, and in the second week I had several incidents where I did not bleed at night, then passed several clots during the day. These clots were typically 2" x 1" x 3" - like a dried apricot - and passed in groups of 2 or 3 at a time. The biggest clot passed like a ripe plum, more like 3-4 inch thick, almost like the entire thickened lining had just been evacuated at once. Towards the end I had some 5-6 inch long, about 1 inch thick coagulated clots.   I had experienced menorrhagia in July's extreme heat wave, but even that heavy bleeding wasn't to this scale of heavy clotting. My doctor and I discussed whether I might take trans. acid, during heavy periods in August. I had a normal period and then another normal period. Then I got the shot and began unusually heavy bleeding for two weeks. Since I knew this wasn't a "period" I called the doctor to find out whether I should take the drug now, and over the weekend the bleeding finally ended.
Patient reported that she had experienced redness and inflammation and swelling at the injection site. She stated that the spot was the size of a half-dollar. She reported that she took BENADRYL and her symptoms improved. The patient made this report to the pharmacy by telephone on 11/16/14 at 4:30 pm.
States that 2 hrs after receiving shot felt sharp pain go down her arm.States that it has been a month now and the pain has not gone away and is very bad with lifting her arm or trying to put her arm in a coat sleeve. States that the pain is in her arm posterior and down to elbow. Denies swelling, redness, numbness or tingling. States that the shot was given very high up on her arm not in the deltoid.
Information has been received from a nurse practitioner concerning a 28 year old Hispanic male employee (aide) with hypertension due to neurogenic bladder (diagnosed 10 years ago) and no known drug allergies, who on 07MAY2003 (also reported as 18MAY2003) at 11:00 was vaccinated SC with a second dose (dose number questionable) of measles virus vaccine live + mumps virus vaccine live + rubella virus vaccine live (second generation). Concomitant therapy included "Motrin" acetaminophen and enalapril maleate 20mg for hypertension. It was reported that there was no illness at the time of vaccination. On 18MAY2003 the patient developed some tonsillar swelling. On 19MAY2003 the patient presented with a macular papular rash on his arms and chest. The reporter stated that the patient did not have a fever, his temperature was 97.5. Unspecified medical attention was sought and no treatment was required. No laboratory or diagnostic testing was performed. Follow up information indicated that the patient had a discrete macular papular rash on his arms and trunk and "tonsillar nodes palpable." The patient recovered on 21MAY2003. Additional information is not expected.
Face hurt; couldn't get out of bed; extreme Fatigue; completely drained of energy, had to force myself to get out of bed to go the bathroom; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (completely drained of energy, had to force myself to get out of bed to go the bathroom), FACIAL PAIN (Face hurt), BEDRIDDEN (couldn't get out of bed) and FATIGUE (extreme Fatigue) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021B21A and 027A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 03-Apr-2021, the patient experienced ASTHENIA (completely drained of energy, had to force myself to get out of bed to go the bathroom). On 03-May-2021, the patient experienced FACIAL PAIN (Face hurt), BEDRIDDEN (couldn't get out of bed) and FATIGUE (extreme Fatigue). On 05-Apr-2021, ASTHENIA (completely drained of energy, had to force myself to get out of bed to go the bathroom) outcome was unknown. At the time of the report, FACIAL PAIN (Face hurt), BEDRIDDEN (couldn't get out of bed) and FATIGUE (extreme Fatigue) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
I had facial swelling for two days after the vaccine and very severe headaches for about 4 days after vaccine.  I continue to get headaches but not as debilitating.  I am weakened and fatigued since one day after the shot and that continues.  I have a constant unwell feeling.  My arms and legs feel weak.
Hives, cluster of 2 patients (patient identification provided) with generalized hives throughout the entire body, after receiving Adacel (lot number C2631AA); Fluzone (lot number unknown), and Menactra (lot number U1922AB), received from a health care professional in the USA on 24 April 2007. Case 1: An 11 year old, female patient ( with a history of no known allergies) developed generalized hives throughout the entire body, 1.1/2 months after she received Adacel (lot number C2631AA); Fluzone (lot number unknown), and Menactra (lot number U1922AB) and Gardasil (Merck, lot number 0014U ) on the 15 February 2007. She has the Fluzone vaccine annually. The patient denies any illness or medications at the time of the vaccinations. She was treated with Cortisone, Singulair and Atarax. It was reported the hives resolved and the patient recovered. The second case  (the patient 's brother ) is detailed in case 2007-01399.
Day of shot had a headache that stared at 4 pm. Lasted till 7 pm next day. Day after shot had aches and muscle pain and could not get out of bed. It hurt to touch my skin. I felt hot/cold all day with soreness in my left arm that got red the size of an orange that went downwards. At around three I felt nauseous but never threw up. Did not feel like eating all day. I was very fatigued the whole day after shot. I was taking ibuprofen and on 11/14/2019 was starting to feel better but still had low energy. I called my doctor on the 13 th and they said if I wasn?t feeling better the next day to come in.
1.5 hours after administration, pt fainted in school hallway. Was disoriented with no recollection of event. Otherwise stable. ED eval showed no abnormality in EKG or blood sugar.
This is a spontaneous report from a contactable nurse reporting for herself. A 66-year-old female patient received PREVNAR 13, via an unspecified route of administration on 31Aug2016 at single dose in the left arm for immunisation. At the same time she was vaccinated with another vaccine but she did not remember the name of that vaccine. Medical history was none. There were no concomitant medications. On Sep2016 after two and half to three weeks after the vaccination the patient experienced discomfort, general soreness in her arm; severe pain in her left arm and it's just below the elbow and into the joint, couldn't rotate her arm, all with outcome of recovering. On an unspecified date, one or two days after the vaccination,  she experienced  pain at the injection site with outcome of recovering. Therapeutic measures as a result of the events included treatment with Aleve.
This spontaneous report has been received from a nurse practitioner regarding a patient of unknown age or gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated VARIVAX dose 1, (dose, lot # and expiry date unknown). On 30-MAY-2012, patient received improperly stored VARIVAX dose 2, from lot # 671861/1907AA expiry date: 05-DEC-2013. No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review and records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. This is one of the several reports received from the same reporter. Additional information has been requested.
This child received MMR immunization on 11/27/00. The mother reported raised rash appearing 12/07/00. It spread to the trunk, limbs, and face, afebrile.
Information has been received from a physician concerning a 19 year old female who on an unspecified date was vaccinated with a dose of GARDASIL (lot # not reported, dose number unknown). Approximately a year and a half prior to developing the onset of rapidly progressive ALS (amyotrophic lateral sclerosis). It was unknown if the patient was on any medications or had concomitant vaccinations. Patient died within a year of symptom onset. Patient was found to be positive for a genetic mutation (FUS) recently recognized as associated with early-onset, rapidly progressive ALS. Her parents also had the mutation. It was not reported if the patient had sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Patient seen in the office today by NP and noted to have +erythema nodosum on bilateral legs from ankles to thighs and a few sponts on her arms. Prescribed Ibuprofen and released to return home.
2 weeks after first injection sore neck and shoulder; 2 weeks after first injection sore neck and shoulder.; soreness in upper body; Minor arm soreness at time of injection; This is a spontaneous report from a contactable consumer (patient) reported for himself. A 68-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: E13249, Expiry date: unknown) via an unknown route of administration, administered in left arm on 15Jan2021 13:30 pm (age at vaccination was 68 years) at a single dose for covid-19 immunisation. Medical history included high BP and CIDP in 2006. There were no known allergies. Concomitant medication included amlodipine besylate (AMLODIPINE BESYLATE), atorvastatin (ATORVASTATIN) and losartan (LOSARTAN). The patient experienced minor arm soreness at time of injection. 2 weeks after first injection sore neck and shoulder. Neck so bad had to sleep upright in chair for several days. Was not consistent all time. 3 weeks after first injection, neck pain was better but overall soreness in upper body. The patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL9269, Expiry date: unknown) via an unknown route of administration, administered in left arm on 05Feb2021 07:30 am (age at vaccination was 68 years) at a single dose for COVID-19 immunisation. It was unknown whether the patient received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No treatment was received for the adverse events. The outcome of all the events was recovering.
pulmonary embolisms with the vaccine; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received bnt162b2 (COMIRNATY, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced pulmonary embolism with the vaccine on an unspecified date of 2021. Caller reported having a pulmonary embolism, previously healthy, and the PE was considered unprovoked which she described as having no known cause. Caller said she found information on the VAERS sites regarding pulmonary embolisms, saying that 984 cases were reported, that it has affected 0.47% of people which is 1/200 people. The outcome of event was unknown.  Information about lot/batch number cannot be obtained. No further information expected
At 11.30 am patient stated to feel itching on the neck which progressed to her arms, back and then on the whole body. Patient had red streaks on the arms and breast during the visit (at 2.10 pm) at our Medical Center. Treatment: Benedryl 50 mg tablet administered on the spot and provided the prescription.
Patient present to hospital with short of breath. Work up showed metastatic colon cancer to the liver.  Required liver resection
URINE HAS A STRANGE SMELL; This spontaneous report received from a patient via an unspecified company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 2021, the subject experienced urine has a strange smell. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of urine has a strange smell was not reported. This report was non-serious.
High Fever; Chills; Vomiting; Facial numbness on one side; Body aches; Exhaustion; Pain at injection site; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206) via an unspecified route of administration in the left arm on 09Mar2021 at 11:30 (at the age of 50-year-old) as a single dose for COVID-19 immunisation. Medical history included von willebrand's disease. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medication included escitalopram oxalate (LEXAPRO) for an unknown indication from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL0266) via an unspecified route of administration in the left arm on 16Feb2021 at 12:00 (at the age of 49-year-old) as a single dose for COVID-19 immunisation. The patient previously took tranexamic acid (MANUFACTURER UNKNOWN) and experienced drug allergy. On 09Mar2021 at 18:00, the patient experienced high fever, chills, vomiting, facial numbness on one side, body aches, exhaustion and pain at injection site. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events high fever, chills, vomiting, facial numbness on one side, body aches, exhaustion and pain at injection site was recovered on an unknown date in 2021.  No follow-up attempts are needed. No further information is expected.
Strong headache everyday since the date of vaccination (04/22/2022) for 18 consecutive days. I have taken Naproxen 550 mg, Tylenol and Advil Plus to relief headache with no success. I will wait one more week prior to looking for medical attention.
No additional AE; HCP called to report inadvertent administration of PROQUAD after a temperature excursion that occurred on 10/12/2023 and the patient received the dose of PROQUAD on 10/16/2023.; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 12-OCT-2023, a temperature excursion occurred at -12.4 C for 18 minutes. No previous temperature excursion was reported. On 16-OCT-2023, the patient was vaccinated with an improperly storage measles, mumps, rubella, and varicella (OKA-MERCK) virus vaccine live (PROQUAD) injection, therapy type: rHA, lot #X007087, expiration date: 04-SEP-2024, administered for prophylaxis (strength, and route of administration were not provided) (Product storage error). No additional adverse events were reported (No adverse event).
H1N1 vaccine was administered at 2:15 pm on 10/30/2009 IM in the right deltoid. Injection tolerated well. Patient reported an adverse reaction on 11/2/2009 at 8 am. He noticed a rapid heart beat & fever by about 5 pm on the day of the injection. Slept well. On 10/31/2009 rapid heartbeat subsided and hoarseness in voice noted. Noticed itching, hives over most of body. Used topical Benadryl to no avail and then used OTC Benadryl 25 mg capsules x2 to some avail.  General malaise on 10/31/2009. Slept most of the day. On 11/1/2009 felt tired and rested most of the day. Continues to have hoarseness and to itch today, 11/2/2009.