chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Arm muscle ache; This is a spontaneous report from a contactable other HCP. A 48-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization (Age at Vaccination was 48 years). Patient also received Thalidomide (THALOMID, formulation: capsules, Lot Number: 9802543), via an oral (PO) route of administration on an unspecified date in Sep2013 at 200 mg, 1 time a day and ongoing for erythema nodosum (off label use). Dose, Frequency and Route used: 2) 100-200 mg, 1 in 1 D, PO, 3) 150-100 mg, 1 in 1 D, PO., 4) 50-100 mg, 1 in 1 D, PO, 5) 150-100 mg, 1 in 1 D, PO 6) 50 mg, 28 in 28 D, PO. Therapy Dates (or duration): 2) Sep2014  Unknown, 3) Jul2015  Unknown, 4) May2018  Unknown, 5) Apr2019  Unknown, 6) Apr2021  Ongoing. The patient medical history included ongoing erythema nodosum. The patient concomitant medications were not reported. It was reported that patient had the event after taking Pfizer COVID vaccine. On an unspecified date, the patient experienced arm muscle ache. The outcome of the event was recovered on an unspecified date.    Follow up attempts are completed. No further information is expected.
sick; lost control of bladder; vomiting; nauseated; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick), URINARY INCONTINENCE (lost control of bladder), VOMITING (vomiting) and NAUSEA (nauseated) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History information was reported.  On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 25-Jan-2021, the patient experienced ILLNESS (sick), URINARY INCONTINENCE (lost control of bladder), VOMITING (vomiting) and NAUSEA (nauseated). At the time of the report, ILLNESS (sick), URINARY INCONTINENCE (lost control of bladder), VOMITING (vomiting) and NAUSEA (nauseated) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant product use was not provided by the reporter. No treatment information was provided.
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare providers recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related injuries. On or about September 2015, a healthcare provider administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about December 2015, the patient was treated by a healthcare provider at a hospital for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Pain, redness and swelling at the site of injection - redness described as 4 inches in diameter over phone.
My period started 20 days early and had NOT stopped; First dose and second dose administered on 10May2021; First dose and second dose administered on 10May2021; This is a spontaneous report from a contactable consumer (patient) reported that a 43-years-old non-pregnant female patient received first and second dose of bnt162b2 (Pfizer COVID-19, Solution for injection, Lot Number: EW0179), via intramuscular route of administration on 10May2021, 17:00 (at the age of 43-years-old) on left arm as first dose, single then (Lot Number: EW0186), via intramuscular route of administration on left arm on 10May2021 at second dose, single for COVID-19 immunisation. Medical history included allergic to shellfish and penicillin. Other medical history was none. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient had not been tested for COVID-19. Concomitant medications were not reported. The most recent COVID-19 vaccine was administered in hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and any other medications within 2 weeks of vaccination. The patient received first and second dose on 10May2021. On 13May2021 at 13:00, 3 days post vaccine, the patient experienced bleeding heavily. Her period started 20 days early and had not stopped. She had been seeking treatment and have no pre vaccine condition to cause this type of bleeding. Patient received treatment for the adverse event. The patient had exam blood work ultrasound. The outcome of the event my period started 20 days early and had not stopped was not recovered and other events was unknown.
30 min. after getting vaccines, pt didn't feel well, laid down, after 2 hrs, headache, body aches, very stuffy head and nose. Felt bad for 2-3 days then symptoms cleared up.
Beginning 3/19/21, experienced over 16 significant nose bleeds (right nostril only) until 3/22/21. Blood flow out of nose was extremely pronounced; looked as if something had cut an artery. The blood was not slowly trickling down, it was pouring out of the nose.  does have Severe Hemophilia B (which was check marked on the registration form) so he is very prone to nosebleeds. However, the severity of rate of bleeding and the significant number of bleeds in a 4 day period was extremely unusual.  Also, it took a very long time to stop the bleeds. I had to pinch the nose extremely hard for 35 minutes to stop each bleed.
A Spontaneous report has been received from a health professional concerning a male patient. Patient relevant history, concurrent diseased and concomitant drugs were not provided. Patient had been receiving nasal FLUMIST (intranasal), started on 20-Nov-2014. The patient was administered of half of the contents into the first nostril and therefore did not administer the second half of the dose into the other no which started on 20-Nov-2014 and nurse administered expired FLUMIST (from 2013) to a child. The outcome of the event of after administration of half of the contents into the first nostril and therefore did not administer the second half of the dose into the other no and nurse administered expired FLUMIST (from 2013) to a child was unknown. The report was considered to be non-serious. Reporter considered the events after administration of half of the contents into the first nostril and therefore did not administer the second half of the dose into the other no and FLUMIST and nurse administered expired FLUMIST (from 2013) to a child to be not related to the FLUMIST.
Sore injection site at 10:00pm day of injection. Morning of day after chills, fever, sore throat, cough, short of breath. 48 hours later same symptoms but fever is worse. I?ve been alternating Tylenol and Advil Q 4 hours. Had a COVID test performed on 1/26/2021. Negative results morning of 1/27/2021. Currently extremely sore throat, cough, fever, short of breath.
SUSPECTED CLINICAL VACCINE FAILURE; ALL OF THE OUTLINE SYMPTOMS OF THE WARNING OF THE PAMPHLET ON THE FIRST PAGE OF DESCRIPTION OF COVID 19; SEVERE PAIN AND SCARED THEY ARE GOING TO DIE; FLU LIKE SYMPTOMS; This spontaneous report received from a consumer via a company representative via legal source concerned multiple patients of unspecified age, race and ethnic origin.  The patient's weight, height, and medical history were not reported. The patients received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose not reported, frequency time 1 total for prophylactic vaccination on an unspecified date. No concomitant medications were reported. On 10-JUL-2021, the patients experienced flu like symptoms. On an unspecified date, the patients experienced severe pain and scared they are going to die, cannot smell or taste, suspected clinical vaccine failure, and all the outline symptoms of the warning of the pamphlet on the first page of description of covid 19. The patients were quarantine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the flu like symptoms, severe pain and scared they are going to die, all of the outline symptoms of the warning of the pamphlet on the first page of description of covid 19 and suspected clinical vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a RA: 90000192993. The suspected has been confirmed to be voided (did not meet criteria as reported complaints were adverse events) based on the evaluation/investigation performed. This case, from the same reporter is linked to 20210920740.; Sender's Comments: V0: Medical Assessment comment not required as per standard operating procedure for legal case.
Narrative:  70-year-old male patient with past medical history most significant for hypertension, hyperlipidemia, diabetes, sleep apnea, anemia, CLL (treated with Ibrutinib), thrombocytopenia, and recent diagnosis of COVID-19 who presented to the Emergency Department complaining of generalized weakness and shortness of breath. Patient was walking from the bathroom back to his chair when he felt so weak that he could not make it all way to his chair. He denied any injuries, head or neck pain, back pain, hip or pelvis pain, extremity pain. EMS was called. He stated he had been short of breath. EMS checked room air saturation several times and stated it was roughly 55%. He was placed on nonrebreather with oxygen saturations in the 70s, then additional 6 L via nasal cannula was added at which point he was satting 88 to 94%. Patient stated that he was feeling well once he was on oxygen. In the ED he was receiving 15 L via nonrebreather satting 89%, placed on HFNC @ 40L & 60% FiO2. He had persistent general malaise/weakness but no focal symptoms. He denied chest pain, palpitations, lightheadedness. He had had no recent fever or chills. He stated he has had recent diffuse mild dull myalgias after his flu shot on 9/23/2021. Otherwise afebrile, BP 144/113, HR 115, RR 20. Labs significant for leukocytosis to 15.5 with left shift, Hgb 9.3, procal 1.57, lactic acid 1.75, d-dimer >20. U/A with 20 ketones. He was admitted on 10/10/2021. On 10/17, the patient had an acute decompensation. He had been weaned to nasal cannula (6L) but had a rapidly increasing oxygen requirement. Subsequent ABG 7.47/34/39, patient in severe respiratory distress. He was intubated and was hypoxic in the 70s despite 100% FIO2. Inhaled NO was started with improvement in hypoxemia. CTPE negative for PE. Source of presume sepsis is due to a superimposed bacterial pneumonia and wide spectrum antibiotics were prescribed. The goal was to wean the patient eventually from the ventilator but on 10/21/2021, the patient had PEA arrest and passed away.
Pt developed a varicella like rash on all parts of her body consisting of approximately 15 total lesions. The lesions vary in size and are pruritic. Pt was treated with Caladryl. The pt reports one or two bumps additional every day for the past few days. It was reported that the pt's infant was present at the time of vaccination. Physician's nurse stated that the vaccine should not have been administered.
Sore arm, dizzy, feeling tired, muscle aches, shaking, takes a lot of effort to stand, slight headache
Back pain; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team for a Pfizer sponsored program.  A male patient received bnt162b2 (BNT162B2), administration date Apr2021 (Batch/Lot number: unknown) 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: BACK PAIN (non-serious), outcome "unknown", described as "Back pain". Therapeutic measures were taken as a result of back pain.  Additional information: Reporter would like recommendations on behalf of a patient who is about to start oral steroids but is scheduled to get the second dose of the Pfizer vaccine on 12May. Reporter mentioned that her patient, who received the 1st dose of the Pfizer covid vaccine about 3 weeks ago, was being started on oral steroids meant to help the patient relieve back pain. He is scheduled for the 2nd dose 12May2021. She did not confirm whether the back pain was related to the vaccine or not.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
After the 2nd dose was given in my left arm.  I have had tremors in my left index finger, so much so that I saw a neurologist.  I have also had twitching.  The 2nd dose was given on 1/29/21, and the tremors started on 2/17/21.
Shingles area appeared two days after the second shot. Didn't connect what it was thought maybe an insect sting. After a week of getting worse I went to a clinic and said it was shingles. Was prescribed Valtrex and later developed gout flare-up and sores in my mouth and on my private area. Getting better but not all side-effects have gone away yet.
nausea 2 days after with a bout of diarrhea, then nausea and vomiting that same evening, then diarrhea and nausea on the third day with exhaustion...
Joint ache, hives, swelling in outer edge of upper lip, raspy voice. Symptoms began around 6 pm with joint ache in the hip area.
16 years old received the vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 years old received the vaccine) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Apr-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 years old received the vaccine). On 11-Apr-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 years old received the vaccine) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Treatment medication was not provided by the reporter.
Complained of forearm that - PM both left and right; Next day numbness and tingling, shaking and light headedness lasting 3-4 hours. Nausea 48 hours; Temp normal 2D post.
Extreme dizziness which lasted for over 2 weeks and also palpitations. Now that dizziness is not extreme, it doesn't stop either.  Physician diagnosed it as "Vertigo" and Meclizine 25Mg did not work for me either. Meclizine made me drowsy on top of dizziness.
6/29 mom noticed redness on left arm. When checking out brought pt back to office area to have Dr assess arm. Left arm with a 5 1/2 cm to 7 cm red area where MMR vaccine administered. 6/30 spoke with mom 2 minutes later redness was gone.
Unsure of exact time, however, when customer woke up, left arm was swollen. No fever, no pain, just swollen. Received two vaccines in same arm at same visit.
This is in follow-up to report(s) previously submitted on 6/14/2007. Information has been received from a Registered Nurse (RN) and a 69 year old female consumer with no known medical history or allergies who on 04-MAY-2007 was vaccinated SC with a 0.65 ml dose of ZOSTAVAX (Merck) (lot # 656859/0357U). There was no concomitant medication. On 07-MAY-2007 the patient experienced "upper respiratory problems" and was coughing and then she developed a fever. About ten days after vaccination, on 11-MAY-2007, the patient thought she "might may have developed shingles". She had a "3x6" patch on her waistline that feels "like it was on fire" when anything touches it, no rash was noted. She reported that heat makes it feel better. She felt like this may be shingles because her sister had shingles in the past and had the same burning feeling. The nurse reported that he patient "got shingles" and the rash was present for 2 weeks. The patient did not seek medical attention. The patient was seen in the physician's office, at the time of the appointment there were no vesicles present, her skin was just red. The rash was fairly light and very small. No specimens were collected as the rash had already dried up. As of 29-May-2007, the patient was considered to have recovered from the shingles. Additional information is not expected.
Information has been received from a physician concerning a 9 week old male with no known pre-existing allergies, birth defects or medical conditions, who on 29-OCT-2007 received his first oral dose of Rotateq (lot #656186/1235F).  Concomitant vaccinations included a first dose of PedvaxHIB (lot #656522/0437U) intramuscular in the right thigh, a first dose of Pediarix (lot #AC21B133BA) intramuscular in the left thigh and a first dose of Prevnar (lot #B701438) in the left thigh.  There was no reported illness at the time of vaccination.  On the night following the vaccinations (29-OCT-2007), it was reported that he developed irritability with a high pitched cry, and fever lasting 48 hours.  It was reported that the sites of injections were swollen.  On 01-NOV-2007 it was reported that he developed green watery stools, knees to chest crampy pain upon eating, frequent night time waking screaming, and yellow jelly like stools for 2-3 days and he was drinking 50% of his usual intake.  It was reported that there were no adverse events following previous vaccination.  The patient sought emergency room and/or a doctor's visit (not specified).  It was reported that he had a normal physical exam and that diagnostic studies and laboratory tests were not ordered.  Current patient status was not reported.  A product quality complaint was not reported.  Additional information has been requested. 03/04/08 This is in follow-up to report(s) previously submitted on 12/14/2007. Follow up information indicated that the patient's crampy abdominal pains resolved by one month after vaccination and the diarrhea resolved in about two weeks. As of 30-NOV-2007, the patient had recovered. The patient was reported to have been growing and developing normally. Additional information has been requested.
This spontaneous report was received from a medical assistant, concerning a multiple patients of an unknown gender and age. There were no concurrent conditions, medical history and concomitant medications reported. On unspecified dates, the multiple patients could had been vaccinated with improperly stored doses of ROTATEQ oral solution (dose and frequency were not reported) lot # M019708 with expiration date of 25-OCT-2017, lot # M025563 with expiration date of 06-NOV-2017 and lot # M031807 with expiration date of 02-APR-2018. The medical assistant had no details about the excursion regarding the time and temperature but just stated that "the vaccines went out of range once." No adverse effects were reported. No product quality complaint (PQC) and data logger were involved. This is one of three reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1702USA005698: US-009507513-1702USA001654.
Pt received the Zoster vaccine at appx 3:10p 9.17.10. He remained in clinic for observation. Appx 15-20 minutes post vaccination he reported experiencing chest pain and dizziness. He was placed on an exam table. VS assessed. EMS activated. He was transported to ER.
Pain in (L)/ shoulder about 8 hours after flu shot. Seen family doctor and referred to an orthopedic doctor and doing physical therapy.
Patient received expired dose; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired dose) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired dose). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received expired dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. It was reported that the HCP mentioned because of miscommunication as a coworker told that there were some lot number whose expiration dates had been extended, patient received expired dose. The patient received second booster dose. No treatment information was reported
Had shots last Thursday, now today his jaw is swollen.  Both sides are affected and also forehead pressure symptoms started today.  Noticeable edema not painful.
Flu like side effects for 3 days, including fever.  A week later, large, hot and itchy rash at injection site
Hives all over the body, itchy and loss of sleep. Zyrtec and cortisone creams did not help. Ended up with steroids and a antibiotic,
One hour after vaccine given, pt c/o lip tingling, "lump in throat" and chills. NP on site advised BENADRYL and notified supervisor. NP also encouraged not to receive vaccination in future. Pt had rash and nerve pain after vaccine last year.
Headache, fever, chills, loss of appetite, vomiting, fatigue/hard of breath.
From initial information received on 06/09/04 from a RN regarding an adverse event occurring in the USA, it was reported that a 2 year old female pt received a dose of DAPTACEL, Lot # C1614AA, administered IM in the right thigh and a dose of IPOL, Lot # X0772, administered SC in the left thigh on 06/01/04.  Approximately 24 hours later, on 06/02/04 at 11:20pm, the pt developed cellulitis in her right leg. The area was red, warm and swollen and measured 3.5x6 inches in diameter. She was treated with oral Clindamycin for 2 days. Reportedly, the pt recovered from these events.