chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Healthy pregnancy with no complications. Received COVID booster shot at 33 weeks pregnant. No side effects or symptoms for myself (mom) after booster. Baby was born about 4.5 weeks later at 37 weeks, 6 days. Normal uncomplicated labor and delivery, but baby was found immediately to have a prematurely closed ductus arteriosus with subsequent pulmonary hypertension and right ventricular hypertrophy. Cardiologists taking care of her suspect that the PDA closed a few weeks before birth, possibly corresponding with the timing of the COVID booster. To date, there has been no known other cause of the PDA closure (no maternal medication contraindications, etc). Baby's due date was 11/17/21, born on 11/2/21. Birth weight was 8lbs 6oz. Baby is still hospitalized in the ICU, ventilated and struggling cardiovascularly.
Information has been received from a healthcare worker (office manager) concerning a 5 year old female with no allergies/drug reactions and no pertinent medical history who on 27-AUG-2008 was vaccinated IM with PNEUMOVAX (lot # 659010/1537U). Concomitant therapy included (INFANRIX) (lot # not reported), (IPOL) (lot # not reported), MMR, (lot # not reported), and VARIVAX (lot # not reported). On 28-AUG-2008 the patient developed local reaction at injection site including pain, erythema, warmth and a fever of about 102 degrees F. The patient sought unspecified medical attention. At the time of the report the patient was recovering from local reaction at injection site including pain, erythema, warmth, and a fever of about 102 degrees F. No other information was available. Additional information has been requested.
This spontaneous report as received from a nurse refers to a patient of unknown demographics. No concurrent conditions or medical history were not provided. On 03-NOV-2014, the patient was vaccinated with ZOSTAVAX injection, 0.65 ml administered subcutaneously (lot# reported as J008526 with expiry date 19-OCT-2014). No concomitant medications were reported. No adverse effect was reported. Lot number J008526 is an invalid lot number for ZOSTAVAX. Additional information has been requested.
Very larger area of induration with warmth, pain, and tenderness on palpitation, body aches, nausea and vomiting, headaches.
One week after the vaccination I found that the site of my vaccination was swollen, red, and slightly itchy.   I consulted my general practitioner, and he told me that it appears to be an infection.  He prescribed an antibiotic (Keflex) to be taken for seven days.  He also advised me to take Benedryl two days before my second vaccination and to receive the shot in my right arm this time.  The swelling and redness are nearly gone--as is the itching.
Reaction from Influenza vaccine, flu like symptoms. Asthma reaction due to vaccine.
Aproximately one minute post asministration of the vaccine into the left deltoid, pt complained of a fast heartbeat and feeling warm. She felt weak and needed tp lie down. She began twitching but never lost consciousness and was alert. She then developed a few hives on her abdominal wall and face. Her face especially under her chin was swollen. After about three minutes she complained of shortness of breath and wheezing. I treated her with oral benadryl 25mg and zantac 150 mg. Over the next hour her symptoms largely subsided although the next morning she said she felt very achy and still somewhat weak.
6/17/04 noted swelling of left arm. 6/18/04 swelling was diffuse from upper arm to 2cm below elbow arm red, skin blanches. Nontender but pruritic per child.
Patient woke on Saturday feeling flushed and itchiness centralized to her face. The redness and itchiness radiates to her neck and she noticed little bumps on her neck. She reported to the clinic on 29Oct2018 and stated the itchiness had not subsided. She was itchy all over her face including her lips. She stated she had not issues at any time with her breathing, swallowing or experiencing any itchiness or swelling inside her mouth. She had not taken any medications to help reduce the itchiness.
severe psoriasis; Eczema; Mild itching on both her hands and feet; Fishers on her feet; This spontaneous case was reported by a consumer and describes the occurrence of PSORIASIS (severe psoriasis), ECZEMA (Eczema), PRURITUS (Mild itching on both her hands and feet) and SKIN FISSURES (Fishers on her feet) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in April 2020. Concurrent medical conditions included Autoimmune disorder (autoimmune diseases).   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-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 experienced PSORIASIS (severe psoriasis), ECZEMA (Eczema), PRURITUS (Mild itching on both her hands and feet) and SKIN FISSURES (Fishers on her feet). At the time of the report, PSORIASIS (severe psoriasis), ECZEMA (Eczema), PRURITUS (Mild itching on both her hands and feet) and SKIN FISSURES (Fishers on her feet) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2020, SARS-CoV-2 test: positive (Positive) COVID Positive.         No concomitant medications were reported by the reporter.  The patient had fishers three weeks after her second dose.  Treatment medication was not provided by the reporter.   This case was linked to MOD-2021-220879 (Patient Link).
No additional AE reported. No PQC reported. No additional information provided.; Customer called and reported that a 10 month old was administered a GARDASIL-9 vaccine today, 24OCT2022. The 10 month old was supposed to be receiving a flue shot; however, GARDASIL-9 was inadvertently administered instead.; Customer called and reported that a 10 month old was administered a GARDASIL-9 vaccine today, 24OCT2022. The 10 month old was supposed to be receiving a flue shot; however, GARDASIL-9 was inadvertently administered instead.; This spontaneous report was received from am medical assistant concerning a 10-month-old male patient. His concomitant therapies, pertinent medical history, and drug reactions/allergies were not reported.  On 24-OCT-2022, the patient was supposed to receive a flu shot. However, he was inadvertently administered with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection instead (strength, dose, route of administration were not reported; lot#: U037064, expiration date: 10-AUG-2024) for prophylaxis (product administered to patient of inappropriate age; wrong product administered). No additional adverse event (AE) was reported.
My son received the second dose of the Pfizer COVID-19 vaccine on 10/22/2021. In May or June 2022, he was exposed to COVID-19 through family and got sick. He took a home antigen test and got a positive result. He had a fever of about 100 or 101 for one day. He had fatigue, body aches, and a runny nose. He was down for maybe about a day or two, but around day 5, he showed few or no symptoms. It was basically like a bad cold he quickly got over.
MORE SYMPTOMATIC (PSORIASIS FLARES UP MORE)  WITH THE COVID-19 VACCINE; This spontaneous report received from a consumer concerned multiple patients. The patient's height, and weight were not reported. The patient's concurrent conditions included: psoriasis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced more symptomatic (psoriasis flares up more) with the covid-19 vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of more symptomatic (psoriasis flares up more) with the covid-19 vaccine was not reported. This report was non-serious.
problems with nerves and perspiration; problems with nerves; hadEssential Tremors for13 months; This case was reported by a consumer via interactive digital media and described the occurrence of tremor in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced tremor, sweating abnormal and neurological disorder nos. On an unknown date, the outcome of the tremor was recovered/resolved and the outcome of the sweating abnormal and neurological disorder nos were not recovered/not resolved.   It was unknown if the reporter considered the tremor, sweating abnormal and neurological disorder nos to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication. The patient received 1st dose of Shingrix and experienced tremor for 13 months, and still had problems with nerve and perspiration. The patient visited to neurologist.
Injection site red; Injection site swollen; Injection site painful; This case was reported by a other health professional via interactive digital media and described the occurrence of injection site erythema in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th August 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced injection site erythema, injection site swelling and injection site pain. On an unknown date, the outcome of the injection site erythema, injection site swelling and injection site pain were unknown.   It was unknown if the reporter considered the injection site erythema, injection site swelling and injection site pain to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The age group was captured as adult as per Shingrix indication.  On 5th September 2019, at 13:37 hrs. the injection site was still red, swollen and painful. The patient enquired should I be concerned. The follow up was not required. The clarification has been requested for the onset date of event.
Was being monitored for low but stable platelets, after receiving both doses of vaccine, platelets dropped by 15%; Was being monitored for low but stable platelets, after receiving both doses of vaccine, platelets dropped by 15%; This is a spontaneous report from a non-contactable consumer (patient) received via COVAES. A 53-year-old male patient received BNT162b2 (BNT162B2), via an unspecified route of administration, administered in left arm on Jun2021 (Batch/Lot number was not reported) (at the age of 53-years-old) as dose 2, single; and via an unspecified route of administration, administered in right arm on Apr2021 (Batch/Lot number was not reported) (at the age of 53-years-old) as dose 1, single for COVID-19 immunisation. Facility where the most recent COVID-19 vaccine was administered in a school or student health clinic. Medical history included low platelet count Immune thrombocytopenic purpura (ITP). The patient has no relevant past drug history. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and did not receive any other medications within 2 weeks of vaccination. In Jul2021, the patient was being monitored for low but stable platelets, after receiving both doses of vaccine, platelets dropped by 15%. The adverse event resulted in a doctor or other healthcare professional office/clinic visit. There was no hospitalization prolonged and no treatment received. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has been tested for COVID-19 since the vaccination. The patient underwent lab tests and procedures which included nasal swab test with result: negative in Aug2021. The outcome of the event was not recovered/not resolved.   No follow-up attempts are possible. No further information is expected.
Felt better from Covid symptoms; Felt better from Covid symptoms; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old male patient received BNT162b2 (BNT162B2), on 13Jan2021 as dose 1, single (Lot number: EL1284), in left arm, on 04Feb2021 as dose 2, single (Lot number: EL1284), in left arm, on 30Sep2021 as dose 3 (booster), single (Lot number: 301308A), in left arm and on 07Apr2022 as dose 4 (booster), single (Lot number: FK9893) at the age of 70 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood presurre" (unspecified if ongoing), notes: High blood pressure only mostly due to anxiety; "Anxiety" (unspecified if ongoing), notes: High blood pressure only mostly due to anxiety; "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin. Concomitant medication(s) included: TERAZOSIN, start date: 01Apr2021; LOSARTAN, start date: 04Dec2018; CARVEDILOL, start date: 01Mar2019. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Felt better from Covid symptoms". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: Unknown Results, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: It was reported that patient had taken Paxlovid (anti viral) for COVID 19 Treatment from 19May2022 to 23May2022. Felt better from Covid symptoms (headache, cough, runny nose, fatigue) after taking Paxlovid. On 3rd day after taking drug symptoms came back. Lost taste and Smell a few days later although have returned. Runny nose, cough stopped after 3 days, mild sinus headache on and off and scratchy throat now never had fever. There were other medications in 2 weeks.   No follow-up attempts are possible. No further information is expected.
5 minutes after vaccine. pt c/o feeling weak, headache, tightness in throat.
Diagnosed with pancreatitis 10/6/09 here at Emergency Room.  No obvious other cause of the pancreatitis. 10/13/2009 received hospital records for 10/6-10/10/2009.  DC DX Acute Pancreatitis.  Patient presented with c/o's epigastric pain, chills, and  nausea. Received vaccine 10/2/2009. Admitted to ICU for monitoring,
Deep vein thrombosis from groin to knee; This is a spontaneous report from a contactable consumer (patient). This 58-years-old male patient received the second single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) in left arm, on 04May2021 at 14:00 (lot EW0171), at the age of 58 years, for COVID-19 immunization. The first dose of BNT162B2 vaccine was administered on 09Apr2021 at 15:00 (at 58 years of age), lot: EP7533, in left arm. Medical history included COVID-19. Past drug history included allergy to lamotrigine (LAMITRIL). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications were not reported. On 21May2021 the patient deep vein thrombosis from groin to knee. The event required ER visit, Doctor or other healthcare professional office/clinic visit, hospitalization for 6 days and was reported as serious also as life-threatening condition. Treatment received included removed blood clot and blood thinners administration. The event was resolving at the time of report. Since the vaccination, the patient had not been tested for COVID-19.
I experienced full-body muscle and joint pains, waves of fever and chills, headache, and swelling in my lymph nodes under my right arm (site of shot) starting about 12 hours after the dose. Today, 3 days later, I noticed puffiness on the right side of my neck. I still have moderate fatigue and muscle and joint pain, but those are mild compared to earlier.
This spontaneous report was received from a 58-years-old female patient via company representative. The patient was reporting on herself. The patient's pertinent medical history and drug reactions or allergies were not reported. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX, 0.65 ml/injection, subcutaneously, to "prevent shingles" (lot# and expiration date were not reported). Concomitant medications were not provided. On an unknown date (reported as "after the patient received her ZOSTAVAX"), the patient developed gastritis, which was treated with an unspecified treatment. The patient's present status was reported as recovering at the time of the report. The patient sought medical attention - she called her doctor. The relatedness between gastritis and ZOSTAVAX was not provided. Additional information has been requested.
Rash has developed primarily in torso area.  I can feel it spreading to the ground and behind my ears.; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the left arm on 16Apr2021 at 14:00 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. Medical history included hashimoto's disease (reported as hashimoto). The patient no known allergies to medications, food, or other products. Concomitant medications taken within two weeks of vaccination included levothyroxine (MANUFACTURER UNKNOWN), atorvastatin (MANUFACTURER UNKNOWN) and escitalopram (MANUFACTURER UNKNOWN); all from unknown date for unknown indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the left arm on 26Mar2021 at 14:00 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 18Apr2021 at 17:00, rash had developed primarily in torso area. The patient could feel it spreading to the ground and behind her ears. No therapeutic measures were taken as a result of the event. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the event rash had developed primarily in torso area, the patient could feel it spreading to the ground and behind her ears was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Hives/rash for 3 days all Over body. Treated with Claritin.
Myalgia, Arthralgia, Fatigue Narrative:  Awoke morning after immunization with muscle and joint aches. Symptoms subsided by that evening.
fever went up 99.9; woke up covered in sweat; shaking so bad; shivering; had trouble keeping balance; swaying when walking; felt like crap; This is a spontaneous report from a contactable consumer. A 52-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on Dec2020 at a single dose SINGLE DOSE for COVID-19 immunization. Medical history included COVID-19 in Apr2020. The patient's concomitant medications included celecoxib (CELEBREX). After receiving the vaccine fever went up 99.9, woke up covered in sweat, shaking so bad, shivering, had trouble keeping balance, was swaying when he was walking on an unspecified date. The patient also stated he felt ill for 3-4 days. The outcome of the events was unknown.    Information about lot/batch number has been requested.
Patient received Moderna COVID vaccine on 1/28/21, 2/26/21, and 11/3/21. On 1/6/22, patient admitted to our med/surg unit with orthopedic consult for bilateral knee swelling, painful joints including knees, ankles, hips / hx of gout, and incidentally positive COVID status upon admission (with clear CXR, good O2 saturation on room air, and no COVID symptoms). As of today (1/7/22), patient is still hospitalized in the med/surg unit to undergo left knee US arthrocentesis to determine any infection. Overall, positive COVID status but asymptomatic during hospitalization.
Vertigo.  Began around 11;00 am. Could not lay down of the world seemed to spin.  Sometimes sitting up too. Husband said eyes were rapidly moving. Made me vomit. Stayed still as much as possible. No drugs, other than Acetaminophen taken. I went to bed at 8:30, propped up on 3 pillows. Woke up fine the next morning.
Post vax the patient's ears started popping, she felt dizzy, her equilibrium was off all weekend, middle ear was stuffed and she had pressure in the head areas.
12/31/2021 Didn't feel good, had a scratchy and sore throat with a low grade fever and headache. I went the next day to have a COVID test and tested positive. Did a self test. Had COVID for 4-5 days and has now recovered.
I82.401 ACUTE DVT OF RIGHT LEG, UNSPECIFIED VEIN 4/10/2023 OSTEOARTHRITIS OF BILAT KNEES
I had a flu shot and pneumonia shot. I swelled up to past my elbow. It was painful and red.
On 1/27/2021 I had to go the ER (Hospital)  for stomach pains.  I had CBC,CMP, urinalysis, CT of the abdomen.  The results of CT abdomen 1.3cm left adrenal nodual.   I was discharged from ER to followed up with specialist (oncology/urologist).  I had an MRI done with the specialist which showed a lesion.  She will be getting more follow ups and PET scan.
Pt called pharmacy complained of redness and swelling from site of injection down her arm similar to sunburn. Was experiencing numbness/tingling in her pinky. Shot was given 6/14/14 at 5 pm.
itchy; knee arthropathy; UTI; This spontaneous case was reported by a physician and describes the occurrence of PRURITUS (itchy), URINARY TRACT INFECTION (UTI) and ARTHROPATHY (knee arthropathy) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) 40 mg. In January 2021, the patient experienced URINARY TRACT INFECTION (UTI). On an unknown date, the patient experienced PRURITUS (itchy) and ARTHROPATHY (knee arthropathy). At the time of the report, PRURITUS (itchy) had resolved and URINARY TRACT INFECTION (UTI) and ARTHROPATHY (knee arthropathy) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.   No corrective treatment was provided.
Pediatric Pfizer vaccine was not diluted prior to administration, resulting in a higher than authorized dose.
Reporting you my side effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Reporting you my side effects.) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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) dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Reporting you my side effects.). At the time of the report, VACCINATION COMPLICATION (Reporting you my side effects.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.        no concomitant medications and treatment medications was provided.