chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Swollen injection site for multiple days; Vomiting; Fever; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 24-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COVID-19 VACCINE OMI XBB.1.5 - MANUFACTURER UNKNOWN), as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "COVID-19" (unspecified if ongoing), notes: If COVID prior vaccination: Yes, covid treatment: Yes; "Beta Thalassemia" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Covid -19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 Immunisation; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN, Anatomical location: Right arm), for COVID-19 Immunisation. The following information was reported: VACCINATION SITE SWELLING (non-serious), outcome "recovering", described as "Swollen injection site for multiple days"; VOMITING (non-serious), outcome "recovering"; PYREXIA (non-serious), outcome "recovering", described as "Fever". Therapeutic measures were not taken as a result of vaccination site swelling, vomiting, pyrexia.  Additional information: Patient did not receive other vaccine in four weeks. She had other medications in two weeks. She had not tested for covid post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Day after vaccination pt found hypotensive at facility (SBP 70), pale. Has leukocytosis. No etiology found on blood tests, exam or imaging yet.
The vaccine the patient received was opened May 4th, 2022 at 3:30pm. Patient received the moderna  COVID-19  on the left deltoid on May 6th, 2022 at 4:19pm.
Shingles.     January 26th - Received first Pfizer vacccine at hospital February 8th - infusion of Remicade 500 mg February 13th - skin started to get pins and needles and very painful February 15th - Received second Pfizer vaccine at hospital February 17th - Patches started appearing, extremely painful, went to dermatologist and was diagnosed with Shingles.  February 18th - blisters started appearing on right side of face . Cheekbones, nose, under eye, cheek, upper lip
This case was reported by a healthcare professional and described the occurrence of diarrhea in a 49-year-old female subject who was vaccinated with TWINRIX (GlaxoSmithKline). Previous vaccination included 1st dose of TWINRIX given on 3 June 2011. The subject had no adverse events following that vaccination. On 1 July 2011 at 14:00 the subject received 2nd dose of TWINRIX (unknown route, right arm). On an unspecified date, less than one year after vaccination with TWINRIX, the subject experienced diarrhea. At the time of reporting the event was unresolved. The subject had not contacted her physician and had left a voice mail which was collected by the reporter. The healthcare professional noted that the subject had received the vaccination for travel prophylaxis and that the subject could have picked up an illness while travelling.
No adverse events or side effects were reported by the patient or her parents. Patient came in to receive her 2nd dose of Pfizer Covid 19 vaccine in the primary series and it was noticed at that time that she received the Pfizer Covid 19 Bivalent Updated Booster for her initial dose. The vaccine was not administered, both Pfizer Manufacturer and the CDC were contacted on next steps, both the patient and her parents were notified of the event and what to do next (contacted via phone and via email). Parents were very understanding. Patient is well and unharmed.  Per Pfizer and the CDC-  If a bivalent Pfizer-BioNTech vaccine is administered in error for a primary series dose: Do not repeat the dose. The primary and booster dosages are the same; the bivalent dose can be counted as a primary series dose.
Fatigued started in morning  (he felt as if he couldn?t push a door open) in the afternoon came the  headache and vomiting towards  the early evening.
All of the symptoms that you list from the injection site; Feeling ill; Pretty high fever; shivering so bad I couldn't even type and went home to bed; All of the pain all of the muscle and bones and all of the other in the back; All of the pain all of the muscle and bones and all of the other in the back; All of the pain all of the muscle and bones and all of the other in the back; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 01Mar2021 (Batch/Lot Number: EN6205) as single dose for covid-19 immunization. Medical history included blood pressure high, overweight, breast cancer and had breast cancer surgery in 2015 and went on the 5-year cancer pill (unspecified medication). Concomitant medication includes cancer pill (unspecified medication) for breast cancer. The patient stated that she had nearly all the symptoms that was listed from the injection site on Mar2021, other than that, she did not have nausea or swollen lymph nodes. About 26 hours after she took the vaccine (Mar2021), she started feeling ill and it just seem to climax to about 4 o'clock when she must say she had pretty high fever she was at work, shivering so bad she couldn't even type and went home to bed. She did take Tylenol and managed. She thinks the 4 next morning (Mar2021), she was breaking the fever but still was not able to go to work. She still felt, other than this fever was gone, she still had all of the pain, of the muscle and the bones and all of the other in the back. So, she had to stay home for two days, pretty much in the bed, the whole time. And she was looking forward to her second vaccine which was on the 24th (24Mar2021), that maybe it would not affect her or may be not too bad, but she ended up staying home again another two days. The outcome of the events muscle pain, back pain and bone pain was not recovered while the other events were unknown.
Has been having like pain in shoulder, numbness; Has been having like pain in shoulder, numbness; The pain started in the shoulder, neck and went down the back.; The pain started in the shoulder, neck and went down the back.; This is a spontaneous report received from a contactable consumer or other non-healthcare professional (Patient).  A 67-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN0164), via an unspecified route of administration, administered in Arm Right (Right shoulder) on 07May2021 (age at the time of vaccination was 67 years) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications was not reported. On an unspecified date in 2021, It was reported that the patient has been having like pain in the shoulder, numbness. Seemed like it was not going away. The pain started in the shoulder, neck and went down the back. The pain came and went like nerves. The patient stated that this began just before June. It was still persisting. No investigation Assessment was reported. The caller stated he already saw his doctor. The caller stated he probably needs a new doctor. The outcome of all the events was not recovered.  Follow-Up (10Aug2021): Follow-up attempts are completed. No further information is expected.
Only the grey vial was given; Only the grey vial was given; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA732A, expiry date 31st October 2023) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 07-OCT-2022 Reporter's comment: The reporter stated that he/she was working in a doctor's office.  Someone in their office used a Menveo vaccine, only the grey vial medication was given.  The reporter asked did they have to give the patient both vials together or could they just give them the red vial. The reporter did not know which of the patient's didn't get the red vial. The reporter went to give one and found the mistake. They did not know when it happened. The reporter found the extra red top yesterday (day before reporting) when he/she took out a red and a grey top to use. The reporter stated that only one bottle (red) left in the box. So it could be one of 3 patients. The reporter consented to follow-up via mail. Additional Supportive Information: The patient received only the grey vial of the vaccine, which led to Inappropriate preparation of medication and Inappropriate dose of vaccine administered.
did not received the second dose of the Moderna vaccine before the 36th day after the first one; Got the first dose of the Moderna vaccine on 20Jan2021 and 3 days ago took the first dose of the Pfizer vaccine; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of PRODUCT ADMINISTRATION ERROR (Got the first dose of the Moderna vaccine on 20Jan2021 and 3 days ago took the first dose of the Pfizer vaccine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (did not received the second dose of the Moderna vaccine before the 36th day after the first one) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    Concurrent medical conditions included Hypertension (The patient is taking high blood pressure medication).   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, the patient received first dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On 13-Mar-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (Got the first dose of the Moderna vaccine on 20Jan2021 and 3 days ago took the first dose of the Pfizer vaccine). On 16-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (did not received the second dose of the Moderna vaccine before the 36th day after the first one). At the time of the report, PRODUCT ADMINISTRATION ERROR (Got the first dose of the Moderna vaccine on 20Jan2021 and 3 days ago took the first dose of the Pfizer vaccine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (did not received the second dose of the Moderna vaccine before the 36th day after the first one) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant Medication was provided. No treatment  was provided.
Itching at site on 1/20.  On 1/26 redness extending to 3"x6" area from site.  Warm to the touch.
The caller went on to say that she attempted to look at the package insert provided with the package, but there was no information on how to administer the vaccine and the information was "missing".; The caller said she kept the vaccine at room temperature for about 15 minutes before administering the vaccine.; No Adverse Event; This spontaneous report was received from a nurse refers to a 65 year-old-patient of unknown gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (lot #, expiration date, exact dose, route of administration and anatomical location were not reported) for prophylaxis. Other suspect therapies included sterile diluent (STERILE DILUENT).    It was reported that the patient was vaccinated because lost immunity and the vaccine boosting his immunity. The caller did not specify if this patient had received with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) in the past. The caller said she is not sure if she reconstituted the vaccine with sterile diluent (STERILE DILUENT) and wanted to know what would happen if a nurse administered measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) with no sterile diluent (STERILE DILUENT). The caller also said she was not sure if measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) needed to be administered intramuscularly or subcutaneously and did not confirm if she administered the vaccine the correct route. The caller went on to say that she thinks she reconstituted the vaccine and saw a total amount of 0.5mL of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) in the vial after reconstitution. The caller said she kept the vaccine at room temperature for about 15 minutes before administering the vaccine (product storage error). The caller went on to say that she attempted to look at the package insert provided with the package, but there was no information on how to administer the vaccine and the information was ''missing'' (physical product label issue). When this agent tried to clarify these statements, the caller became upset and refused to answer any questions. The caller declined to provide permission to be contacted and then said she did not have time and hung up on this. No additional adverse event reported (no adverse event).
Firm lump at the site of injection; This case was reported by a physician via sales rep and described the occurrence of injection site lump in a 17-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received the 1st dose of Bexsero. On an unknown date, 30 days after receiving Bexsero, the patient experienced injection site lump. On an unknown date, the outcome of the injection site lump was recovered/resolved.   It was unknown if the reporter considered the injection site lump to be related to Bexsero.  Additional details were reported as follows: The patient experienced a residual firm lump at the site of injection post 1 month. At 2 months, no lump. No pain associated with lump at the 1 month post injection. Patient received 2nd dose 2 months post 1st injection. No side effects after 2nd injection.
Within a couple hours of administration, patient got a "pounding headache" or migraine and tiredness that lasted for about 2 days. She also claims that she started her period that same day despite being on a regular oral hormonal contraceptive (she wasn't supposed to get her period for another 2 weeks). She denied it was spotting and said it lasted for about 3 weeks, though unsure if triggered by vaccine.
79-year-old male history of CAD status post PCI over 20 years ago presented to the emergency department with complaint of multiple episodes of chest pain with activity and at rest.  Hospitalist consulted for admission for monitoring overnight with serial troponins.Admitted to cardiac bed with telemetry serial troponins with mild elevation peak 0.05.  Cardiology was called recommending Cardiolite stress test patient without any recurrent episodes of chest pain throughout hospitalization.  EKG with no acute ST or T wave changes.  Cardiolite stress test normal.  Patient medically stable for discharge home.  We will have him follow-up with his cardiologist within 1 week. Event does not seem related to COVID vaccine. Reported submitted as required per EUA.
Excruciating pain; Swollen ankle; Red spot on the arm; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Red spot on the arm), PAIN (Excruciating pain) and JOINT SWELLING (Swollen ankle) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     Concurrent medical conditions included Thyroiditis. Concomitant products included COLECALCIFEROL (VITAMINS D3), MAGNESIUM CITRATE and PROBIOTICS NOS for an unknown indication.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced ERYTHEMA (Red spot on the arm). On 22-Jan-2021, the patient experienced PAIN (Excruciating pain) and JOINT SWELLING (Swollen ankle). The patient was treated with COLCHICINE on 22-Jan-2021 for Gout, at a dose of 1 dosage form and PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, ERYTHEMA (Red spot on the arm) and PAIN (Excruciating pain) outcome was unknown and JOINT SWELLING (Swollen ankle) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Jan-2021, Blood test: inconclusive (Inconclusive) No gout marker found in blood.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Other concomitant products includes Thyroid medication and Drop digestion Iberogast.   This case was linked to MOD-2021-024898 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 24-Jun-2021: Follow up received on 24-JUN-2021 contains non significant information. Patient's contact information was updated.
pt recvd flu vax 15OCT93; bruised area noted 22OCT93; herpes zoster entire lt arm & forearm medial side of lt arm & forearm 24OCT93 dx 25OCT93;
Systemic Lupus erythematosus; Sjogren's syndrome which was ten times worse; triggered her Lupus and her Sjogren's syndrome which was ten times worse; sinuses had bloody mucus for 6 months that felt like it was in the chest; could not breathe correctly; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 2022NVX-US-000003989.  A female patient received BNT162b2 (BNT162B2), in Aug2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Systemic Lupus erythematosus" (unspecified if ongoing); "Sjogren's syndrome" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1), for COVID-19 Immunization; Bnt162b2 (Dose 2), administration date: Apr2021, for COVID-19 Immunization, reaction(s): "Sickness", "very nauseous", "felt like she just had a fever".  The following information was reported: SYSTEMIC LUPUS ERYTHEMATOSUS (medically significant), outcome "unknown"; SJOGREN'S SYNDROME (medically significant), outcome "unknown", described as "Sjogren's syndrome which was ten times worse"; RHINORRHOEA (non-serious), outcome "unknown", described as "sinuses had bloody mucus for 6 months that felt like it was in the chest"; DYSPNOEA (non-serious), outcome "unknown", described as "could not breathe correctly"; CONDITION AGGRAVATED (medically significant), outcome "unknown", described as "triggered her Lupus and her Sjogren's syndrome which was ten times worse".  Clinical information: On 25Oct2022, it was reported that a patient started treatment on Apr2021 with Pfizer BioNTech COVID-19 Vaccine at dose 2 for COVID-19 immunization and got very sick for 10 days. The patient was very nauseous and felt like she just had a fever. The patient also had a booster on Aug2021 which was really bad. It lasted for 6 months and felt like it just never really recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Raised red rash and welts all over head, lower face (both sides), on sides of the tongue, neck (front and back), all over torso (front and back), both arms, palms of hands, both shoulders, and upper thigh (groin area). Smallest spot was the size of a pencil eraser, largest spot the size of a silver dollar. Extremely itchy. Needle like pain occurred 1 to 2 hours before the rash appeared. First appeared on the upper torso, then spread up and down from there.  Voice became hoarse and remained that way as long as the rash was present.  After taking oral prednisone (2 tablets once daily), topical prednisone (1%) and 2 (25mg) benedryl every 4 hours for 48 hrs rash lightened and disappeared. Raspy voice disappeared as well.
3-21-14 - Bil arms red swollen and warm to touch. (L) arm - 2 1/2 - 2"" circle and 0.5 cm knot, R - 3 1/2 - 3 1/2 circle area. GM gave antihistamine 3-20-14 and said looks better today. Worse on 3-19 and 3-20-14.
67 year old male arrives at vaccination clinic for administration of first dose. Patient was oriented about the vaccination process, possible side effects after getting the first dose and advised about the date and the process for receiving the second shot. Vaccination process was uneventful. 2 days later, the coordinators and medical director was contacted by municipal epidemiologist informing the patient received a third shot of the vaccine. After reviewing the documents presented by the municipal official, in fact the patient was vaccinated in another clinic, but the vaccination card has missing information such as incomplete name, unknown facility. Also, the previous 2 doses were not registered in the online database.
This spontaneous report as received from a pharmacist refers to a female patient of unknown age. The pharmacist noted that the patient (it was not disclosed if there was any relationship between this patient and the pharmacist), was administered her first dose in the GARDASIL vaccination series intramuscularly in approximately July 2012, "about a year ago" and then was administered with the second dose in the GARDASIL vaccination series intramuscularly today (on 09-JUL-2013). No adverse effect reported. Additional information has been requested.
Persistent, inconsolable crying for over 2 hours.  Reported by mother 09/30/2003.  States baby was evaluated by pediatrician who recommended DT thereafter baby doing fine now.
Patient had episode of chills, vomiting, and headache starting about 12 hours post vaccine.  Patient continues with headache while all other symptoms have resolved.