chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Abdominal pain  This case was reported by a medical assistant and described the occurrence of abdominal pain in a 19 year-old female subject who received hepatitis B vaccine recombinant (Engerix-B).  No history of problems with the initial dose of Engerix-B.  On 15 May 2006, the subject received the second dose of Engerix-B (lot AHEXB180AC) in her arm.  Approximately two hours following the administration of Engerix-B, the patient experienced an abdominal pain and abdominal cramps.  The reporter considered that the events were probably related to the use of Engerix-B.  The outcome of the abdominal pain and cramps was worse. Later on follow-up, the physician noted that the subject was doing  fine and the abdominal pain was not due to Engerix-B.
nurse went in the wrong room and administered it to the wrong patient.; Initial information regarding an unsolicited non-serious case was received from a physician via agency (Reference number- 00504028) and transmitted to Sanofi on 04-Mar-2021.  This case involves a six years old male patient who was administered with a 0.5 mL dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot number and expiration date were not reported) via intramuscular route in left deltoid for prophylactic vaccination by error on 03-Mar-2021 because nurse went in the wrong room and administered the wrong patient (Wrong patient received product ).  Medical history, past medical treatments, past vaccinations and family history were not provided.  Concomitant medication included MENINGOCOCCAL VACCINE B (MENINGOCOCCAL VACCINE B) for Immunisation.  It was actual medication error due to wrong vaccine administered (on same day).  The reporter states that there was a mix up and a 6 year old patient that was just there to be seen for some other reason (not a vaccine) received a Menactra vaccine that was meant for another patient because the nurse went in the wrong room and administered it to the wrong patient. The reporter questions if there are any side effects that they should be aware of and if this throws off the scheduled 11-year-old vaccine. The reporter would like to know the possible side effects for the patient. The patient was scheduled to receive a flu shot.  At the time of report, the patients experienced no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information on the batch number for this case.
My arm is swollen and it's red; My arm is swollen and it's red; rest part is bigger than my hand and it feels like burning and itchy sensation; rest part is bigger than my hand and it feels like burning and itchy sensation; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 30Sep2021 (Lot number: FF8841) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1), for Covid-19 immunization, reaction(s): "didn't have any reactions"; Bnt162b2 (Dose: 2), for Covid-19 immunization, reaction(s): "didn't have any reactions". The following information was reported: PERIPHERAL SWELLING (non-serious), ERYTHEMA (non-serious) all with onset 2021, outcome "unknown" and all described as "My arm is swollen and it's red"; BURNING SENSATION (non-serious), PRURITUS (non-serious) all with onset 2021, outcome "unknown" and all described as "rest part is bigger than my hand and it feels like burning and itchy sensation".  No follow-up attempts are possible. No further information is expected.
Cardiomyopathy, ?etiology, respiratory arrest 8/19/06. Hospitalized.
PATIENT RECIEVED VACCINATION ON 1/28/22 PATIENT WENT TO HOSPITAL THE WEEKEND OF 2/5/22 AND LATER PASSED ON 2/7/22. HER FAMILY REPORT SHE PASSED AWAY FROM PULMONARY EMOBLI
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 provider recommended and/or prescribed the ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 05-MAY-2014, a healthcare provider administered the ZOSTAVAX to the patient. In February 2017, the patient was treated by a healthcare provider for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of his 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 (dates unknown), 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 (unspecified); 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.
little tingling in my tongue; broke out into a cold sweat; face got really hot and flushed; face got really hot and flushed; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA ORAL (little tingling in my tongue), COLD SWEAT (broke out into a cold sweat), FLUSHING (face got really hot and flushed) and FEELING HOT (face got really hot and flushed) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced PARAESTHESIA ORAL (little tingling in my tongue), COLD SWEAT (broke out into a cold sweat), FLUSHING (face got really hot and flushed) and FEELING HOT (face got really hot and flushed). On 09-Feb-2021, PARAESTHESIA ORAL (little tingling in my tongue), COLD SWEAT (broke out into a cold sweat), FLUSHING (face got really hot and flushed) and FEELING HOT (face got really hot and flushed) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.
Started as pain at injection site 4 hours post injection. Swelling began shortly after. (R) deltoid now rigid and painful.
Around 2 hours after MMR injection mother noticed mild swelling of scrotum bilaterally, did not appear to be tender or erythematous. resolved after warm compresses and 1 single dose of tylenol within first 12 hours.
very high temperature; This spontaneous case was reported by a consumer and describes the occurrence of BODY TEMPERATURE INCREASED (very high temperature) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced BODY TEMPERATURE INCREASED (very high temperature). At the time of the report, BODY TEMPERATURE INCREASED (very high temperature) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant information was not provided.  Treatment information was not provided.
Patient was given KINRIX (DTaP/IPV) combo at 6 wks of age.
17 Year Old Received Vaccine; A spontaneous report was received from a Consumer concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273).  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 17 Mar 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 003A21A) intramuscularly for prophylaxis of COVID-19 infection.  The patient received vaccine at the age of 17 Years.  Laboratory details were not provided. No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event was recovered.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age (17 year old female) for mRNA-1273 (lot number unknown) with no associated AEs reported.
Medical assistant calling to report a temperature excursion that occurred 8/14/2020 which involved the following products: GARDASIL9, PEDVAXHIB, RECOMBIVAX, ROTATEQ. Per caller, "it would be possible that at least 100 patients have received vaccines; This spontaneous report was received from a medical assistant, concerning a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies or concomitant medications were not reported.  On 08-SEP-2020, the patient was vaccinated with an improperly stored doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally as prophylaxis (lot # 1660991 with expiration date 27-APR-2021) (strength and frequency were not reported) and with haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) 0.5 ml as prophylaxis (lot # S036821 with expiration date 21-APR-2022) (strength, frequency, route of administration and anatomical location were not reported).  The improperly stored doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) and haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) experienced a temperature excursion of 35.4 Fahrenheit degrees (°F) for the time frame of 20 minutes without previous temperature excursions. It was confirmed that a digital data logger was involved.  This is one of several cases from the same reporter. ; Sender's Comments:  US-009507513-2009USA006106:
Tinnitus; started a few days after second dose. Ongoing most nights ever since. Has significantly improved but still present when environment is very quiet. I now always sleep with a fan on and sometimes cannot sleep from the ringing.
The next day after the shot he was covered in hives - chest, stomach and back. It took 4 days for them to go away
Passing out; This is a spontaneous report from a non-contactable consumer (patient).  A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date, single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced passing out on an unspecified date with outcome of unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Received Fluarix in left arm and Trumenba in right arm the morning of 10/9/20.  Mom called at about 3:00pm that day to report that he said he "felt a little funny" after the Trumenba in right arm was administered but they didn't think anything of it.  45 min after the vaccine he c/o h/a.  Mom became concerned and called us when he called for her and he was in the bathroom floor saying he had the worst h/a he had ever had and he felt nauseous.  Provider advised that he drink down about 30 oz of Gatorade now and then continue to hydrate throughout the day with water. Provider recommended that if he continued to feel concerned to take him to the hospital.  Mom said she didn't feel the need to take him to the hospital. Redness and tactile warmth lasted until 10/10/20 and patient said he "felt like he was coming down with something" but by that night, he was completely fine.
Patient was erroneously administered the COVID Vaccine at one of our mass vaccination clinics, and she does not meet the minimum age requirement per the EAU guideline.
Patient called this morning and said she had the usual adverse reaction on 5/7/23 low grade fever, weakness, chill, muscle ache and joint ache., then on 5/8/23 she woke up with swollen lips and edge of her nose.  She said it didn't get worse or swollen tongue or throat.  She felt normal otherwise. We helped pt to call PCP  and pt also got an appt with md right away to be evaluated.  Patient said she didn't have any of these reaction with the first Shingrix dose.
Dose administered #10:15am 9/9/21 - sore at injection site as expected 9/10/21 7:30 pm - noticed that injection site was warm and area spread to 2.5 x 3 inches. Applied ice pack to injection site.
(1) fatigue beginning at 7pm, (2) from 2am until about 2pm the next day: headache, body aches (arms, legs, back, neck), chills, fever 101°, heavy fatigue,  sleeplessness, (3) high blood glucose levels all the next day. (4) At this time injection arm still sore, somewhat lightheaded,.
Rash, exact date it started is a little unclear but by 1/13/21 it was extensive on extremities and trunk. Not itchy, deep red flat spots, nonblanching. No other associated symptoms like URI, fever, myalgias  Seen by dermatology on 1/18/21.  Biopsy done -  Seen by dermatology again 1/25/21. Started on Prednisone 60mg x 5d, 40mg x 5d, 20mg,x 5d. Rash slowly faded over the next 3-4 weeks. Mild residual discoloration noted in some areas.
Redness, soreness to arm, tired, dizzy, nausea, stiffness.
On the day following vaccination, patient called the pharmacy complaining of a red, swollen, softball size area at site of injection.
Achy left arm and left armpit resulting in me taking Ibuprofen. (Took 3 -400mg pills over 12hrs)
red/pinkish at injection site; weak; redness going down the arm; pinkish; Chills; Dizziness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), VACCINATION SITE DISCOLOURATION (red/pinkish at injection site), ASTHENIA (weak), ERYTHEMA (redness going down the arm) and VACCINATION SITE ERYTHEMA (pinkish) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A and 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included COPD. Concomitant products included METOPROLOL, FUROSEMIDE (LASIX [FUROSEMIDE]), SIMVASTATIN, WARFARIN, LORAZEPAM, VITAMIN D3, VITAMIN C [ASCORBIC ACID] and FLUTICASONE FUROATE, UMECLIDINIUM BROMIDE, VILANTEROL TRIFENATATE (TRELEGY) for an unknown indication.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Apr-2021, the patient experienced DIZZINESS (Dizziness), ERYTHEMA (redness going down the arm), VACCINATION SITE ERYTHEMA (pinkish) and CHILLS (Chills). On an unknown date, the patient experienced VACCINATION SITE DISCOLOURATION (red/pinkish at injection site) and ASTHENIA (weak). At the time of the report, DIZZINESS (Dizziness) and ASTHENIA (weak) outcome was unknown, VACCINATION SITE DISCOLOURATION (red/pinkish at injection site) and VACCINATION SITE ERYTHEMA (pinkish) had not resolved, ERYTHEMA (redness going down the arm) was resolving and CHILLS (Chills) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the event was not applicable. Treatment for the event was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-078550 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2021: Follow up received on 15 Apr 2021 included information of concomitant medications-Warfarin, metoprolol, Lasix, lorazepam at night, simvastatin, vitamin D3, trilogy, vitamin C, first dose batch no.030A21A, events outcome.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-078550:First dose vaccination
Metallic taste in mouth within minutes of receiving the vaccine (Pfitzer booster  after  J&J vaccine in April );  Swelling behind the left knee, with some pain and discomfort, 18 hours after receiving the booster vaccine
D-DIMER HIGH; HEADACHE; SENSATION OF THE VACCINE RUNNING DOWN ARM INTERNALLY; This spontaneous report received from a patient concerned a 76 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient had no medical history. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 1808978 and expiry: UNKNOWN) dose was not reported, administered on 25-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 25-MAY-2021, the patient experienced sensation of the vaccine running down arm internally. On JUL-2021, Laboratory data included: Fibrin D dimer (NR: not provided) High. On an unspecified date, the patient experienced d-dimer high, and headache. Laboratory data (dates unspecified) included: Fibrin D dimer (NR: not provided) High. The action taken with covid-19 vaccine  was not applicable. The patient recovered from headache, was recovering from d-dimer high, and the outcome of sensation of the vaccine running down arm internally was not reported. This report was non-serious.
Client c/o feeling dizzy, no loss of consciousness, no other complaint was made.  Client was examined by medic on site.  Upon assessment client transferred to Hospital via ambulance due to elevated BP 190/100 for further evaluation.
Patient discharged after ( 2) day inpatient stay. 11/22-11/24/2021 The patient is a 92 y.o. male who presents today with shortness of breath and fatigue.  The patient has a pertinent medical history for coronary artery disease, hypertension, hyperlipidemia, and PE in August and currently on Eliquis until 11/24 (plan to continue while inpatient).  Additionally the patient sustained a fall in July with a right hip fracture and subsequently underwent an ORIF with cable fixation and currently has persistent inability to void since the fall.  He has had a urinary catheter since this fall.  History has been obtained from the patient and his daughter.  The patient tested positive for COVID-19 on 11/18.  He reports symptoms started on 11/16 at include fatigue, weakness, cough in these have progressed over the following days which led him to seek the ER.  While in the ER he was found to be mildly hypoxic at 88-90% on room air and was placed on 1 L nasal cannula.  He was given dexamethasone remdesivir for treatment of COVID -19. While in the ER his CRP was quite elevated at 134.3 and a procalcitonin was elevated at 0.45.  He was given Rocephin and azithromycin for possible bacterial pneumonia   The patient's daughter met with hospice this am, and requests that patient be discharged from hospital back to his home.  She will sign him onto hospice this afternoon.  Per her wishes, patient will be discharged on oxygen and given prescriptions for dexamethasone and antibiotics.
Per childs Mother, childs behavior was odd, then sudden onset of child turning blue and not breathing, eyes rolled back in head, then child became limp. She came to on her own, the entire event lasted 2-3 mins. No further medical care was sought at the time. Mother called this office this AM and discussed this w Dr who believes this is a minor reaction to a vaccine as it may have been a seizure. Child is now back to baseline.
Swelling & pain at injection site. Swelling of pinna. joint pain, rash. Treated with antihistamine.
The pt experienced a 5 cm x 4 cm edematous lesaion with an erythematous center with a central open lesion. The lesion is approximately 3 mm. The pt experienced a fever of 100.3, developed 24 hours post injection.
Tenderness after my first two Moderna vaccines; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (Tenderness after my first two Moderna vaccines) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Previously administered products included for Product used for unknown indication: Flu shot (Over many years). Past adverse reactions to the above products included No adverse event with Flu shot.Concurrent medical conditions included BP raised (normal readings with medication. Lowered to 150mg) since 06-Jan-1999, Asthma on 04-Jan-2006, Sleep apnea (changing from CPAP to oral device) since 03-Jan-2020 and Penicillin allergy (Allergy to penicillin). Concomitant products included FLUTICASONE PROPIONATE (FLOVENT HFA) from 04-Jan-2006 to an unknown date and MONTELUKAST from 04-Jan-2006 to an unknown date for Asthma, IRBESARTAN from 06-Jan-1999 to an unknown date and HYDROCHLOROTHIAZIDE from 06-Jan-1999 to an unknown date for BP raised, COLECALCIFEROL (D3) for an unknown indication. 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. On an unknown date, the patient experienced TENDERNESS (Tenderness after my first two Moderna vaccines). At the time of the report, TENDERNESS (Tenderness after my first two Moderna vaccines) outcome was unknown. Not provided.For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered TENDERNESS (Tenderness after my first two Moderna vaccines) to be possibly related.  Patient took flu shot years ago.No treatment information was provided. Company Comment: This spontaneous case concerns a 64-year-old, female patient with no relevant medical history, who experienced the unexpected, non-serious event of tenderness following administration of the second dose of the Moderna mRNA-1273. The start date of the event was not provided. The rechallenge was not applicable since no information about the first dose is available. The benefit-risk relationship of the Moderna mRNA-1273 is not affected by this report.This case was linked to MOD-2021-385483, MOD-2021-367382, MOD-2021-367382 (Patient Link). Sender's Comments: This spontaneous case concerns a 64-year-old, female patient with no relevant medical history, who experienced the unexpected, non-serious event of tenderness following administration of the second dose of the Moderna mRNA-1273. The start date of the event was not provided. The rechallenge was not applicable since no information about the first dose is available. The benefit-risk relationship of the Moderna mRNA-1273 is not affected by this report.