chrisvoncsefalvay/vaers-outcomes huggingface dataset:
hospitalized for acute pancreatitis; acute renal failure; fatigue; very poor appetite; abdominal pain; started having confusion; This is a spontaneous report from a contactable physician.  A 88-years-old female patient (not pregnant) received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN6207), second dose via an unspecified route of administration on 24Mar2021,single dose for covid-19 immunisation. Medical history included chronic kidney disease from an unknown date and unknown if ongoing , atrial fibrillation from an unknown date and unknown if ongoing , pulmonary hypertension, allergies to medications, food, or other products: clindamycin, levofloxacin, sulfa drugs, penicillin from an unknown date and unknown if ongoing. Patient started having fatigue immediately after 2nd dose vaccination. 3 days later (27Mar2021), patient had very poor appetite, abdominal pain and started having confusion. 6 days later (30Mar2021), patient was hospitalized for acute pancreatitis and acute renal failure. Events resulted in going to the emergency room/department or urgent care. Treatment received for the adverse event was IV rehydration, levophed, vasopressin, dobutamine, cefepime and flagyl. The outcome of the events was unknown. No COVID prior vaccination. Patient had COVID test post vaccination (nasal swab) on 31Mar2021 with result of negative.  No follow-up attempts are possible.; Sender's Comments: By close temporal relationship, the company cannot completely exclude a contributory role of BNT162b2 in the development of the reported diagnosis of acute pancreatitis and acute renal failure. Medical history including  chronic kidney disease in the setting of elderly age, cannot be also excluded as confounding factors.  The impacts 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.
Patient had severe pain at injection site with fever at the site. She had difficulty lifting arm. She continues to have pain at the site although it has gotten better.
Headache, severe chills the same day. Took ibuprofen. Felt better following day.
Headache, upset stomach, chills, body ache, injection site pain, lack of appetite that lasted for 30 hours. Took 1000 mg acetaminophen 3x during this period.  Read CDC report on side effects of this vaccine which was very helpful.
shingles; PHN/throbbing pain and residual nerve demage; Information has been received from a lawyer concerning a case in litigation and refers to female patient of an unknown age. No information regarding the patient's medical history, concurrent conditions and concomitant medications was reported. On 27-FEB-2018, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, vaccination site, lot # and expiry date were not specified) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date in 2018 (reported as "less than two (2) months after receiving zoster vaccine live (ZOSTAVAX)), the patient suffered debilitating injuries including painful and debilitating shingles as well as post herpetic neuralgia (PHN), significant throbbing pain and residual nerve damage. All of these injuries were caused by zoster vaccine live (ZOSTAVAX). As a direct and proximate result of the Company's defective zoster vaccine live (ZOSTAVAX) vaccine, the patient's symptoms have resulted in physical limitations not present prior to using the Company's product and caused by the zoster vaccine live (ZOSTAVAX) vaccine. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition and has suffered economic losses due to her inability to work. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and disfiguring personal injuries. Further, as a tragic consequence of Merck's wrongful conduct, the patient suffered serious, progressive, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of the Company's conduct, the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was not recovered. The causality was related.  The events of shingles and PHN were considered to be disabling.
Pt was seen Monday here in the office for 2 month WCC and was given vaccination. When the band aids came off that evening the area under the band aids were red on both legs. Tuesday his arms and legs began to break out. Today right side of face is red and pt is broken out with red bumps all over his legs, arms, and back, not on belly area As above. Infant broke out in rash after immunizations on Monday. Mom was very concerned yesterday about infant not eating well, but after Tylenol infant gtts appetite has picked up and infant more consolable today. No fevers have been noted. Generalized skin eruption over extremities sparing chest, back and somewhat face. There is some involvement of chin but no mucous membrane lesions noted. Lesions are numerous over extremities and appear maculopapular with noted vesicles.
injected arm started getting very hot; The shot hurt; Hot fever; Red area around the shot; RA flare gotten worse; dizzy; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (RA flare gotten worse) in an elderly patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Rheumatoid arthritis and Allergic reaction NOS (patient had history of allergic reactions.).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jan-2021, the patient experienced VACCINATION SITE WARMTH (injected arm started getting very hot). On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (RA flare gotten worse) (seriousness criterion medically significant), DIZZINESS (dizzy), VACCINATION SITE PAIN (The shot hurt), PYREXIA (Hot fever) and VACCINATION SITE ERYTHEMA (Red area around the shot). At the time of the report, RHEUMATOID ARTHRITIS (RA flare gotten worse), DIZZINESS (dizzy), VACCINATION SITE WARMTH (injected arm started getting very hot), VACCINATION SITE PAIN (The shot hurt), PYREXIA (Hot fever) and VACCINATION SITE ERYTHEMA (Red area around the shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.; Sender's Comments: This case concerns an elderly patient of unknown age with a serious unexpected event of rheumatoid arthritis, and nonserious unexpected dizziness, vaccination site warmth and expected pyrexia, vaccination site pain, vaccination site erythema.  Event onset the same day as first dose mRNA-1273. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Menstrual cycle off since taking covid vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4515151-00 (AbbVie).  A 52-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: AMENORRHOEA (non-serious), outcome "unknown", described as "Menstrual cycle off since taking covid vaccine".  Additional information: On unknown dates, the patient experienced menstrual cycle off since taking covid vaccine and patient still had minor plaque psoriasis breakouts. Pfizer BioNTech COVID-19 vaccine (TOZINAMERAN) was also considered suspect. The patient still had minor breakouts and stubborn spots. She used topical ointment for those spots. Her menstrual cycle was off since she took COVID vaccine. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Adverse event information provided by patient was not related to covid vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Day 7 post-dose (first Moderna vaccine dose), woke up with swelling of both eyes, more severe around left eye (injection given in left arm), became more severe upper and lower both eyes, with redness and itching. Also some redness and itching both ears and scalp.  This progressed to jaw pain on both sides. Had bruise around injection site with a bit of pain, but on Day 10 had grapefruit-sized red swelling distal to injection site.  Began taking OTC antihistamine on Day 7 for eye swelling but swelling became more severe so went to Urgent Care center on Day 10. They recommended starting RX Prednisone 40 mg QD and RX Hydroxyzine 25 mg BID, to be started in a.m. on Day 11.  Eye swelling improved but is still present, with some itching, as of Day  18.  Redness and bruise on arm has resolved.
During 15 minute post-vaccine observation, patient reported numbness in the left arm that radiated to the back. After 10 additional minutes, patient described the sensation as a burning, tingling sensation that could be felt in her arm and back. Temperature of affected areas did not differ from remainder of body. Pharmacy staff called 3 hours later. Patient reported that pain/tingling resolved with one dose of Acetaminophen.
Patient presented to the clinic today with a rash that has lasted for 12 days.  She had the Varicella Vaccine on 09/16/05 in our clinic.  Since then she has had the pustular rash that presents on her stomach at first and then dissapears and returns on another area of the body.  The CDC told us that no treatment was necessary.  She should stay away from pregnant women or immunosuppressed people until the rash subsides. The patient should have no more varicella vanccines in the future.  This was a adverse reaction.  Up to 5% of the cases have had the rash lasting up to 3 weeks.
Cried all night after getting shots on 9/28/04: Dtap, IPV, Hep B, Hib Prevnar, Varivax. On 9/29/04 at 8AM had 1 min generalized. TC seizure, prompting ER visit. Exam normal x low grade T 100, fussiness. Neck supple.
I received my first Pfizer vaccine dose 3/8/21 and my second 3/30/21. A few weeks later, I went to the dentist with jaw pain. She said she's seen a lot of mouth inflammation after the vaccine. The pain went away. I went back to the dentist a few weeks later for a cleaning, and she noticed I had an enlarged thyroid. I didn't get it checked out until July because we moved internationally. The doctor referred me for a neck ultrasound and bloodwork. The ultrasound indicates thyroiditis, perhaps Hashimoto's, and my Thyroid Peroxidase Ab levels are over 1300 IU/ml.
Woke up 3rd morning after vaccination and my legs would not move, very restricted movement of both arms, serious pain in shoulder joints, knee joints and ankle joints.  Condition limited my ability with great difficulty to self dress, get out of chairs and walk.
tingling of her tongue; This is a Spontaneous report based on the information received by Pfizer (Reference No: CH-2021000074-00) from a contactable consumer (patient). A female patient of an unspecified age received unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number and Expire Date were not reported), via an unspecified route of administration, on an unspecified date, as a single dose for COVID-19 immunization. The patient's medical history included actinic keratosis. Concomitant medications were not reported. On an unspecified date, the patient experienced tingling of her tongue. She mentioned that she had COVID shot from Pfizer and might be the tingling of her tongue was the reaction of her body. Additionally, the patient confirmed that the product (unspecified) was prescribed for her Actinic Keratosis. She explained that she only got the tingling when she used the product at night. She mentioned that the dermatologist instructed her to use it five nights a week for six weeks; however, on the third week, she realized that she used it seven days a week. She asked if overusing it could do any harm. She added that her tongue tingled a little bit; however, the spots on her face cleared-up. She did not have the tingling all day on her tongue. It was only when she put it on and then it started to go and then during the morning it wore off. During the call, she mentioned that she was still experiencing the tingling on the tongue but very little. She experienced it when she used the product more to 7 days than the 5 days. The consumer refused to provide her email address. She provided the consent to call her back for follow-up questions. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
6 days after vaccination, developed large erythematous patch that was pruritic, warm and covered upper humerus in area that was vaccinated, consistent with late onset dermatologic reaction.
Vaccination failure; Covid-19; Interchange of vaccine products; This is a spontaneous report received from contactable reporter(s) (Physician) from product quality group. The reporter is the patient.  A 76-year-old male patient received BNT162b2 (BNT162B2), on 22Dec2020 as dose 1, single (Lot number: EJ1685), in left arm, on 12Jan2021 as dose 2, single (Lot number: 1685), in left arm and on 08Oct2021 as dose 3 (booster), single (Lot number: ff8839) at the age of 75 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 22Apr2022 as dose 4 (booster), single (Lot number: 033K2124), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 22Apr2022, outcome "unknown"; VACCINATION FAILURE (medically significant), outcome "unknown"; COVID-19 (medically significant), outcome "unknown". Therapeutic measures were taken as a result of covid-19. Clinical course: Patient treated COVID-19 with Paxlovid from 02Mar2023 till 07Mar2023. Patient had no allergies.; Sender's Comments: The efficacy of a vaccine varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine product BNT162B2 to the reported events vaccination failure and COVID-19 cannot be ruled out.,Linked Report(s) : US-PFIZER INC-202300108517 same patient, diff drug/event;
patient fainted; shortness of breath when standing up; unable to stand up; excess of sweating; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (patient fainted), DYSPNOEA (shortness of breath when standing up), DYSSTASIA (unable to stand up) and HYPERHIDROSIS (excess of sweating) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028K21A, 007B21A and 0391321A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Jan-2022, the patient experienced SYNCOPE (patient fainted), DYSPNOEA (shortness of breath when standing up), DYSSTASIA (unable to stand up) and HYPERHIDROSIS (excess of sweating). At the time of the report, SYNCOPE (patient fainted), DYSPNOEA (shortness of breath when standing up), DYSSTASIA (unable to stand up) and HYPERHIDROSIS (excess of sweating) had not resolved.      Concomitant medication was not provided.  Patient never tested positive for COVID and did not had any previous condition or any health problem before this.  Treatment information was not provided.  The patient received the booster dose around 3PM and symptoms started at 9 PM on the same day. At the time of reporting symptoms were ongoing and raising.   Reporter did not allow further contact
Swollen arm; Very painful; Fevereal; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swollen arm), PAIN IN EXTREMITY (Very painful) and PYREXIA (Fevereal) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058E21A and 939901) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Aug-2021 at 10:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Sep-2021 at 12:00 PM, the patient experienced PERIPHERAL SWELLING (Swollen arm), PAIN IN EXTREMITY (Very painful) and PYREXIA (Fevereal). On 06-Oct-2021, PERIPHERAL SWELLING (Swollen arm), PAIN IN EXTREMITY (Very painful) and PYREXIA (Fevereal) had resolved.            No concomitant medications were reported. No treatment information was provided.  The second shot caused the patient's arm to swell and also feeling fevereal and was very painful for 2 weeks. The weight of the patient is reported as 179. It was reported that the vaccine was administered at 12:00 pm on an unknown date.   This case was linked to MOD-2021-301662 (Patient Link).
EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a health care professional concerned a 49 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821286, expiry: 21-OCT-2021) dose was not reported, administered on 22-OCT-2021 for prophylactic vaccination. No concomitant medications were reported. On 22-OCT-2021, the patient experienced expired vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine administered was not reported. This report was non-serious.
Local reaction at site - warmth, redness, swelling, bruising. Has a "flushing" redness to skin bilateral upper arms and upper chest - warm to touch, mild itching. Mild reaction that started last night, has not worsened but also has not resolved as of yet.
Severe Sore Throat; Stiff neck; Shortness of breath; Back ache; every bone and every part of her body hurt; every bone and every part of her body hurt; pain under her ribs; weak and shaky; weak and shaky; biceps ached; Fatigue; tremendous headache; This is a spontaneous report from a contactable consumer (patient). An 83-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration on 28Mar2021 14:00 (Batch/Lot number was not reported: did not get a card that lists NDC, Lot, Expiration) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had no history of all previous immunization with the Pfizer vaccine considered as suspect. It was also reported that no additional vaccines were administered on the same date. The patient did not require visit to Emergency Room and stated that she was desperate and would've gone but she didn't have a ride and added she is worried about the second. Also, the patient did not required visit to the physician's office. No prior vaccinations (within 4 weeks). No family medical history. The patient reported that she received the first dose of the vaccine and 5 days later she got a terrible reaction. She did not expect it. She had a terrible reaction and thought she was going to die. She stated she wanted to report this because the TV says you should expect some kind of reaction after the second dose but does not say after the first and she said that Pfizer needs to know about this reaction. She stated she heard the second dose is worse. The patient asked if she has to get her second dose and if she needs to report this anywhere else? The patient added "what should I do about side effects?" It was reported that the patient (reported as is almost 84) had the first shot on Sunday 28MAR2021 and everything was fine by Friday she was in terrible trouble really really bad. States she has never heard of this, they say the first is easy and everything was terrible. States every bone and every part of her body hurt on 02Apr2021. She states after 24 hours (03Apr2021) it did go away. The patient asks does this happen to other people? It was stated that her symptoms came on suddenly and she had a severe sore throat, stiff neck, back ache, pain under her ribs, very very weak and shaky, shortness of breath, biceps ached, fatigue, and a tremendous headache. It was stated that started on Friday 02Apr2021 12:00 like a hurricane and after 24 hours they subsided on Saturday 03Apr2021. The patient added that she doesn't remember getting a card and didn't know that she should have a card until she saw something about it on TV, and thought well she didn't get a card. The patient also asked what does she do about that?  The patient states she takes medication but not that affects this. The outcome of the events recovered on 03Apr2021.   Additional information has been requested
C/O pressure like pain at chest, SOB, C/O chest pain increasing when bending over.  Denies fever.  Had seasonal flu shot 10/09 without problems
Bad, consistent headaches to date since a couple days after receiving the second vaccine.; This is a spontaneous report from a non-contactable consumer, the patient. A 37-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EW0162) via an unspecified route of administration in the left arm on 27Apr2021 at 10:15 (at the age of 37-year-old) as a single dose for COVID-19 immunisation. The medical history included environmental allergies. 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. The concomitant medications included topiramate (TROKENDI), omeprazole (MANUFACTURER UNKNOWN) and levocetirizine dihydrochloride (XYZAL), all from unknown dates and for unknown indications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: ER8732) via an unspecified route of administration in the left arm on 06Apr2021 at 10:15 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. The patient previously took metoclopramide (REGLAN) and sumatriptan (IMITREX) and experienced allergy. On 29Apr2021, a couple of days after receiving the second vaccine, the patient experienced bad, consistent headaches till date (at the time of the report). It had not gone away, even with medication. The patient received medication (unspecified) for the reported event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event bad, consistent headaches was not recovered at the time of this report.    No follow-up attempts are possible. No further information is expected.