chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Mobility decreased; This spontaneous case was reported by a physician and describes the occurrence of MOBILITY DECREASED (Mobility decreased) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for RA.    No Medical History information was reported.   On 09-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to Dose 2. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and UPADACITINIB (RINVOQ) (Oral) 15 mg once a day. In April 2021, the patient experienced MOBILITY DECREASED (Mobility decreased). At the time of the report, MOBILITY DECREASED (Mobility decreased) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment information was not provided.
C/O approximately 3 inches of redness around the site of vaccine that was given in right arm. Area slightly raised, non-tender, warm to touch and itching. Varicella vaccine administered in right arm SQ.
30 min aproximately of the immunization visit, mom brings child because of a sudden rash in whole body
We gave 3 doses of expired Moderna bivalent; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We gave 3 doses of expired Moderna bivalent) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 069H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (We gave 3 doses of expired Moderna bivalent) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (We gave 3 doses of expired Moderna bivalent) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (We gave 3 doses of expired Moderna bivalent).    No concomitant information was reported. No treatment information was provided. This case is reported for patient 1 out of 3 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-730186, US-MODERNATX, INC.-MOD-2023-730183 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-730183:(Out of 02 Paitents this case for Patient no. 03) US-MODERNATX, INC.-MOD-2023-730186:(Out of 03 Paitents this case for Patient no. 03)
The patient was given Moderna as 2nd dose of series and had received Pfizer for the first dose. No adverse reaction.
This spontaneous report was received from a nurse refers to a unspecified number of patients of unknown age and gender. On an unknown date the patients received improperly stored doses of RECOMBIVAX HB (dosage, route of administration and indication were not provided), which were exposed 8.5 C for 15 minutes. No adverse effect were reported. Thi sis one of several reports received from the same reporter. Additional information has been requested.
Left axillary lymph node enlargement with accompanied pain (injection was administered on the left side). Started with one enlarged lypmh node and progressed to 3 or 4 smaller ones along the same chain. No fevers, sweats or other symptoms noted.
patient given child vaccine 0.2 ml  but it was not diluted with 1.3 ml of normal saline prior to giving
Generalized malaise and fatigue.  Warmth, redness and tight muscle at injection site.  All symptoms continued and progressed for 4 days then resolved.
The day after recieving the vacine the patient experience nausea, vomiting and a temp of 103 degrees F. Spoke with PCP and was confident it was from the vaccine
Child reportedly fussy, irritable and with mild fever during interval between vaccines and death. 2/27/06 Received autopsy report which reveals patient's COD was Sudden Unexpected Death in Childhood/ss No new information found in medical records from PCP.
This spontaneous report was received from a medical assistant and refers to a unspecified patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided. On an unknown dates, the patients were vaccinated with an improperly stored doses of (Oka/Merck) VARIVAX (doses, route of administration, anatomical location, lot# and expiration date were not reported). Administered doses of (Oka/Merck) VARIVAX experienced temperature excursion of 35 degree Fahrenheit for 6 days, on an unknown date. There was no previous temperature excursion. Digital data logger was involved. No adverse effects were reported. Additional information has been requested. This is one of several reports from the same reporter.
Pt. c/o left arm pain and swelling. Noted arm, area red slight swelling confined to injection site, size of .50 cents piece. Able to move extremity well. Suggested child f/u with Pvt. MD. Continue pain med and compresses.
Arm sore; Fatigue; Muscle aches; Nauseated; Fever of 101; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Arm sore), FATIGUE (Fatigue), MYALGIA (Muscle aches), NAUSEA (Nauseated) and PYREXIA (Fever of 101) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     Concomitant products included CIPROFLOXACIN (LABETROL) for an unknown indication.    On 23-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, the patient experienced FATIGUE (Fatigue), MYALGIA (Muscle aches), NAUSEA (Nauseated) and PYREXIA (Fever of 101). On an unknown date, the patient experienced PAIN (Arm sore). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, FATIGUE (Fatigue), MYALGIA (Muscle aches), NAUSEA (Nauseated) and PYREXIA (Fever of 101) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: NNI
I have been sick now for over 13 days and I was vaxed.; I have been sick now for over 13 days and I was vaxed.; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SUSPECTED COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "I have been sick now for over 13 days and I was vaxed.". The patient's parents were both sick with the first wave of COVID and they are now sick again and needed Paxlovid. Tests are scarce and although, they all know why, it is not as important as getting his parents on the medication to save their lives. The patient have been sick now for over 13 days and he was "vaxed" but his concern is for them.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Noticed a rash consisting of several red dots covering the top right side of my right hand, several days after receiving the vaccine. Slight burning sensation from the rash.
Began with a headache, backaches, aching all over my body, followed by chills.  Then progressed to uncontrollable shaking and shivering over the next few hours.  Also had my legs collapse under me while standing at the sink. Went to bed after getting up and taking Advil for the headache.
Patient experienced symptoms: "Light headed" placed pt in supine position with feet elevated... Also gave her crackers, juice, and water. This occurred in 15 min. time span. BP and Pulse were within normal limits, then pt's symptoms relieved.
Patient had a gen rash over arms & legs 2 days after vaccine with MMR/menactra He came to clinic 8 days after rash, by while rash had cleared mostly. Rash was papular very discrete, looked like insect bites. No SOB or anaphylaxis or any other Sx.
Sore arm; Developed a rash on her upper body, which is still itchy; Felt itchy; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Felt itchy), PAIN IN EXTREMITY (Sore arm) and RASH PRURITIC (Developed a rash on her upper body, which is still itchy) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 00BB21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced PRURITUS (Felt itchy) and RASH PRURITIC (Developed a rash on her upper body, which is still itchy). On 23-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PRURITUS (Felt itchy) and RASH PRURITIC (Developed a rash on her upper body, which is still itchy) had not resolved and PAIN IN EXTREMITY (Sore arm) had resolved   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Severe joint pain, severe stomach pain, dizziness, nausea, severe vomiting, chills, mild fever
New Pt. to our clinic.  Present for a pfizer booster vaccine.  Found out after booster injection was given that the pateint had completed the Moderna vaccines.
Patient states he passed out the evening after receiving his 2nd dose. He doesn't know how long he was out. the next day, he was fine.
Rash: in face, upper and lower extremities and buttocks. Wheals, small size (0.5 cm diameter), erythematous.
PATIENT WAS GIVEN MODERNA VACCINE WITH AN EXPIRATION DATE OF 8/31/2021 ON 9/02/2021
Patient complained of constant pain in his throat as well as right ear has been going on for past 2 days.  Patient also states he has some dysphagia.  He describes the pain as stabbing in nature.  Rates it a 10/10.  States it is constant.  States begins at the right ear and radiates down the right side of his neck.  The swelling is no aggravating factor with no relieving factors.  Patient was recently admitted and discharged after being treated for an abscess on the right side of his neck.  However was noted the patient had a new tremor as scheduled for additional radiation chemotherapy.  Patient denies any headache, vision changes, fever, chills, shortness of breath, increased cough, chest pain, heart palpitations, nausea vomiting diarrhea, constipation, abdominal pain, difficulty urinating, increased urinary frequency, blood in his urine, painful urination, patient denies any new numbness or tingling in his extremities.  Patient denies any new edema in his extremities.  Patient denies any recent sick contacts.  Patient denies any recent travel.  Patient has a significant medical history of squamous cell cancer of the tongue.  HIV.  Opioid addiction.  CPAP.  Diagnosed with COVID-19 on 04/04/2021. Received dexamethasone IV, 1L normal saline, fentanyl and ketorolac. Placed on ertapenem for neck. Discharged on 4/9/21. Then re-admitted on 4/11 for dysphagia. PEG tube placed 4/13/21. Discharged 4/16/21.
Dizziness, Myalgia, Tingling/Numbness in hands Narrative:
This is a spontaneous report from a contactable physician received via a Pfizer sales representative. A patient of unspecified age ethnicity and gender received PREVNAR 13, via an unspecified route of administration on an unspecified date at 0.5 ml, single. Medical history and concomitant medications were not reported. The patient experienced cellulitis and pain in the arm on an unspecified date, two weeks later after the injection of PREVNAR 13. Cellulitis was right away but the pain was still there 2 weeks later.
Client reported that she develop reaction from the TDAP she received 7/26/2016. She had pain on the (L) arm, tenderness, redness and some swelling. Also had pain on her rib cage, extreme tiredness, chills, nausea, dizziness. Yesterday felt extremely hot and body aches.
Pt had headache for 3 days and also had swelling at the injection site for 5 days from the injection site to the elbow of their arm.
tenderness at injection site after first dose and soreness at injection site after second dose; mild headache after first dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adult female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 03Mar2021 (Batch/Lot number: unknown) as dose 1, single and administration date 24Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 03Mar2021, outcome "recovered" (2021), described as "tenderness at injection site after first dose and soreness at injection site after second dose"; HEADACHE (non-serious) with onset 03Mar2021, outcome "recovered" (2021), described as "mild headache after first dose". Therapeutic measures were taken as a result of vaccination site pain, headache.  Additional information: The events were treated with Tylenol. There was no covid prior to vaccination, and no covid was tested after vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Sender's Comments: Linked Report(s) : US-PFIZER INC-2021448755 similar report from same reporter
Decreased Pulse and BP; Extreme Fatigue; Fever; Muscle Ache.
Within one month began severe abdominal pain, abnormal behavior (no eye contact, fecal smearing, lost speech), regression in speech and motor skills. Developed sensory problems. Night waking and screaming. Overactive thyroid and yeast.  Nurse follow up on 08/31/04 states: "PDD-pervasive developmental delay; chronic encephalopathy; chronic diarrhea."
Covid test result: Positive; sore thraot; sneezing; runny nose; This is a spontaneous report from a non-contactable Other HCP. This Other HCP reported for a 25-year-old male patient.   A 25-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL3248), via intramuscular route of administration on 03Feb2021 (at the age of 25-year-old), as dose 2, single in right arm; and received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL3248), via intramuscular route of administration on 13Jan2021 (at the age of 25-year-old), as dose 1, single in right arm for COVID-19 immunization at Workplace clinic. The patient's medical history and concomitant medications were not reported. On 16Aug2021, 6 months and 13 days after vaccination, the patient experienced sore throat, sneezing and runny nose. On 17Aug2021, post vaccination, the patient's nasal swab test or COVID test result was positive. It was reported as unknown that patient received treatment for adverse events. The patient underwent lab tests and procedures which included SARS-CoV-2 test (nasal swab): positive, on 17Aug2021. It was reported as unknown if patient had COVID prior vaccination and patient was tested COVID post vaccination. The clinical outcome of all the events was reported as resolving.   No follow-up attempts possible. No further information expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the event SARS-CoV-2 test positive and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.  The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study 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.
Within 2 minutes: trouble breathing (tight chest), light headed, nausea, feeling flush. All symptoms subsided about a minute later.
Patient communicated feeling drowsy with blurred vision. Reported at 11 am. Prior to administering vaccine, the facility of vaccine site operations temperature at 76-77 degrees. Fan's were provided by facility for airflow after reporting patient's symptoms.
pt recv vax 10JUL97 & had trouble-SOB, swelling;denies any systemic sx;no fever;had pain to touch until today;pt playing briskly w/sibling is not gurading in anyway;
SUSPECTED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a 43 year old female. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and expiry: UNKNOWN) dose was not reported, administered on 03-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 23-APR-2021, the subject experienced suspected immunological vaccine failure.  Laboratory data included: Antibody test (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected immunological vaccine failure was not reported. This report was non-serious.
Pt vaccinated with MMR/HIB 1wk later developed high fever 103.6, rash, diarrhea, vomiting for 5 days. ER - Tylenol.
Was diagnosed today with shingles- rash on chest, back and under arm on one side. Stabbing pains and tingling. Have had chicken pox but this is first time with shingles
swelling under her injection arm in the lymph nodes; arm soreness/Could not maneuver her arm which was sore; neck was a little painful; swelling under her arm; Not feeling good at all; nausea; pain in the injection arm; Injection was a quite little, felt like a sting and a burn; chills; weakness; This is a spontaneous report from a contactable consumer (patient) via a Pfizer sponsored program COVAX US support. A 69-year-old female patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EL9269), dose 1 via an unspecified route of administration, administered in Left arm on 13Feb2021 (at the age of 69-year-old) as single for vaccination. Medical history included blood pressure, cholesterol from an unknown date and unknown if ongoing, Patient was allergic to squash. Prior Vaccinations (within 4 weeks) and AEs following prior vaccinations was reported as none. Concomitant medications included hydrochlorothiazide, lisinopril 20/25mg once daily, taken for blood pressure and simvastatin taken for cholesterol 40 mg once daily, start and stop date were not reported. On 13Feb2021 the patient experienced chills, weakness and reported that injection was a quite little, felt like a sting and a burn. On 14Feb2021 she had nausea, pain in the injection arm, arm soreness/ she could not 'maneuver' her arm which was sore, side of her neck was a little painful, swelling under her arm, not feeling good at all. On 15Feb2021 she has swelling under her injection arm in the lymph nodes. The patient was administered the first dose of Pfizer COVID-19 Vaccine 13Feb2021. The injection was a quite little, felt like a sting and a burn but it was just quick. That's ok. She had cold chills though the night of 13Feb2021 and onset of sore arm night of 13Feb2021. On 14Feb2021 morning she just was not feeling good at all, could not 'maneuver' her arm which was sore. She was just feeling nauseated but she did not actually bring anything up. On 14Feb2021 night she noticed the side of her neck was a little painful and right under her arm was a painful swelling. She called to ask if these are side effects of the first dose of Pfizer COVID-19 Vaccine, what can she expect with the second dose of Pfizer COVID-19 Vaccine; will effects be the same or worse. On 15Feb2021 morning, when she got up the right under her arm was a painful swelling is there but is not as painful but it's fading out, going away. She is not having the cold chills, not having nausea, not having not feeling good at all today. The rest were kind of better today. The events not required emergency room and physician office. Outcome of the events neck was a little painful and swelling under her arm was resolving and outcome of other events was unknown.   Follow-up attempts completed. No further information expected.
A report has been received from a Health Professional concerning a 7 year old, male subject, who had been receiving FLUMIST QUADRIVALENT (intranasal). FLUMIST QUADRIVALENT (intranasal) started on 30-Jan-2015. It was reported that patient was administered expired FLUMIST QUADRIVALENT on 30-Jan-2015. The outcome of the event of expired FLUMIST QUADRIVALENT administered is unknown. The report was considered to be non-serious. Corrected report 21-Pct-2015: Key ingredient updated.
Redness, swelling, pain, warmth from above left elbow to site of injection. Treated with acetaminophen and ice. Persisted 7 days.
Shingles infection; This is a spontaneous report from a contactable healthcare professional. A 42-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via intramuscular route of administration in the arm right on 01Apr2021 (at the age of 42-year-old) as a single dose for COVID-19 immunisation. Medical history included bipolar disorder and COVID-19. Concomitant medications included sertraline (MANUFACTURER UNKNOWN), lamotrigine (LAMICTAL), trazodone (MANUFACTURER UNKNOWN) and lithium (MANUFACTURER UNKNOWN) from an unknown date and for unknown indications. The patient had no known allergies. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 11Apr2021, the patient experienced shingles infection. The patient reported that she had shingles infection 2 weeks following vaccine. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of shingles infection and included treatment with VALTREX from an unspecified date in Apr2021 and unknown if ongoing. The clinical outcome of the event shingles infection was not recovered at the time of this report.  No follow up attempts are required; Information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a pharmacist concerning a pt who after vaccination experienced painful urination and frequency in urination. The pt also had an IUD in place. Medical attention was sought. No further information is available.