chrisvoncsefalvay/vaers-outcomes huggingface dataset:
injection site itchy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (injection site itchy) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-May-2021, the patient experienced VACCINATION SITE PRURITUS (injection site itchy). At the time of the report, VACCINATION SITE PRURITUS (injection site itchy) outcome was unknown. Not Provided          Concomitant product information, if any, was not provided by the reporter. Treatment information, if any, was not provided.  Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-118383 (Patient Link).
Patient received Tdap Ipol on 6/11/07. Pt received MMR on 6/15/07. Her mother in law called office on 7/11/07 to report a positive pregnancy test. This would be pregnancy within 28 days of vaccination.
ACHES/BODY ACHE; HEADACHE; FEVER; BURNING SENSATION ON INJECTION SITE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 08-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, Laboratory data included: Body temperature (NR: not provided) 99.5 F. On 08-MAR-2021, the subject experienced burning sensation on injection site. On 09-MAR-2021, the subject experienced aches/body ache. On 09-MAR-2021, the subject experienced headache. On 09-MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from aches/body ache, headache, and fever on 13-MAR-2021, and burning sensation on injection site on 08-MAR-2021. This report was non-serious.
Two days after vaccination, patient began with dry cough, nasal congestion, sore throat, and low grade fever. Symptoms last approximately 9 days. Pt. improved with hot, abundant fluids, Acetaminophen and antitussive/decongestant/steroid oral solution mix.
pt recvd vax & devel rash in area of vax; edema of Lt arm muscle; itching in lt arm; given DPH
sore arm, fever of 102, every muscle ached and it felt like I had been it by a mack truck, and slept most of day
Feel so bad; This spontaneous case was reported by an other health care professional and describes the occurrence of MALAISE (Feel so bad) 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 an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (Feel so bad). At the time of the report, MALAISE (Feel so bad) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment information was provided.  This case concerns a male patient of an unknown age with no relevant medical history, who experienced the unexpected event of Feeling Abnormal. The event occurred on an unknown date after receiving the third dose of mRNA-1273 Vaccine. The rechallenge was not applicable since only information about the third dose was disclosed. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This case concerns a male patient of an unknown age with no relevant medical history, who experienced the unexpected event of Feeling Abnormal. The event occurred on an unknown date after receiving the third dose of mRNA-1273 Vaccine. The rechallenge was not applicable since only information about the third dose was disclosed. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Blister; Redness; This is a spontaneous report from a contactable consumer or other non hcp. A 49-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: UNKNOWN), via an unspecified route of administration, administered in Arm on 17Mar2021 (at the age of: 49-years-old) as dose 1, single for covid-19 immunisation. Medical history included hypothyroidism from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Caller says that his wife got the Pfizer COVID-19 vaccine on 17Mar2021, then yesterday on 18Mar2021 she got a blister on her arm with a little redness on the spot, which he wonders if this is normal or if they should worry about it. Caller says that the blister had stayed the same after 24 hours, the same size, with no treatment. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained
This spontaneous report has been received from a Nurse practitioner, concerning a 79 year old female patient. The patient concurrent condition included hypertension and concomitant medication included amlodipine besylate, EXFORGE. No allergies or drug reaction were reported. In October 2012 (reported as 5 years ago), the patient was vaccinated with PNEUMOVAX23 intramuscularly in the arm (strength, frequency, lot number and expiration date were not provided) for pneumonia prevention. In October 2012 (reported as on the same day), the patient developed swelling on an unspecified arm. The patient was treated with ibuprofen and ice and one hour later, the patient recovered from the event. No lab diagnostics or studies were performed; the patient did not sought medical attention. The causal relationship between the swelling on the arm and the therapy with PNEUMOVAX23 was not assessed.
Patient has developed a Rash on left thigh and knot on Right thighh 1 day post-vaccination patient was given KEFLEX 250mg and asked to come back to rechecked on also called mom few time to check up on patient but patient got better.
I received daily hives that would go away with Allergy medication, for several weeks. I seen a doctor who gave me steroids. I did not take them hoping the hives would go away on their own. They did. It has now been one week since the hives have been gone.
Information has been received from a physician's nurse concerning a female who "about one year ago", in approximately August 2007, was vaccinated intramuscularly with 0.5 ml dose of GARDASIL. In approximately August 2007, after receiving GARDASIL, the patient fainted. Subsequently, the patient recovered an later completed the GARDASIL series with no other symptoms noted. The patient was seen in office. No further information is available.
Patient started sweating, shaking, and was partially unresponsive for several minutes. Called 911 and was determined to be an anaphylactic reaction. She was taken to the ER.
Body aches the next day, dissipating over 48 hours; Irrationally mad for no reason. I just felt angry about everything; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 22Apr2021 14:45 (Lot number: ER8735) at the age of 37 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ADDERALL; ADDERALL XR. Past drug history included: Amoxicillin, reaction(s): "Allergy". Vaccination history included: Bnt162b2 (lot number: EP7533, administration time: 02:45 PM, dose number: 1, vaccine location: Right arm), administration date: 01Apr2021, when the patient was 37 years old, for COVID-19 immunization. The following information was reported: PAIN (non-serious) with onset 23Apr2021, outcome "recovered" (25Apr2021), described as "Body aches the next day, dissipating over 48 hours"; IRRITABILITY (non-serious) with onset 23Apr2021, outcome "recovered", described as "Irrationally mad for no reason. I just felt angry about everything". Therapeutic measures were not taken as a result of pain, irritability.  Additional Information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
This spontaneous report was received from a pharmacist, concerning an adult patient of an unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 05-OCT-2017 (reported as "5 days past the expiration date"), the patient was unknowingly vaccinated with an expired dose of VARIVAX with lot # L037561 and expiration date on 29-SEP-2017 (strength, dose, route of administration, and anatomical location were not provide), for prophylaxis. The reporter was seeking professional advice about the vaccine efficacy in this case and how to proceed with re-vaccination if necessary. It was reported that VARIVAX had not previous temperature excursions prior to administration. No product quality complaint (PQC) was involved.
Reactions were less than the reactions after the 1st vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Reactions were less than the reactions after the 1st vaccine) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006b21A and 030A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Reactions were less than the reactions after the 1st vaccine). At the time of the report, VACCINATION COMPLICATION (Reactions were less than the reactions after the 1st vaccine) outcome was unknown.            Concomitant product information was not provided.  Treatment information was not provided.  After dose 1 was taken patient experienced the event- sore arm and itching but after dose 2 patient stated that the reactions were less than the reactions after the 1st vaccine.   This case was linked to MOD-2021-044350 (Patient Link).
very hot; feeling cold; bump on her arm and developed size of cantaloupe; pain in her arm; arm redness; Hardness; fatigue; muscle pain; joint pain; nausea; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (very hot), FEELING COLD (feeling cold), PERIPHERAL SWELLING (bump on her arm and developed size of cantaloupe), PAIN IN EXTREMITY (pain in her arm) and ERYTHEMA (arm redness) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced FEELING HOT (very hot), FEELING COLD (feeling cold), PERIPHERAL SWELLING (bump on her arm and developed size of cantaloupe), PAIN IN EXTREMITY (pain in her arm), ERYTHEMA (arm redness), INDURATION (Hardness), FATIGUE (fatigue), MYALGIA (muscle pain), ARTHRALGIA (joint pain) and NAUSEA (nausea). At the time of the report, FEELING HOT (very hot), FEELING COLD (feeling cold), PERIPHERAL SWELLING (bump on her arm and developed size of cantaloupe), PAIN IN EXTREMITY (pain in her arm), ERYTHEMA (arm redness), INDURATION (Hardness), FATIGUE (fatigue), MYALGIA (muscle pain), ARTHRALGIA (joint pain) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication provided was allergy medicine. Treatment information provided was two antibiotics.   This case was linked to -MODERNATX, INC.-MOD-2021-071541 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Follow-up information received on 10-May-2021 contains non-significant information.; Sender's Comments:  -MODERNATX, INC.-MOD-2021-071541:Daughter AE's
Pt states worsening rash, frontal headache.  The rash did not occur following injection #1.  Pt described scattered reddened fine papular rash.  No nausea, no difficulty with swallow, no SOB.   No other reported symptoms.  cough virtual visit was conducted with the patient.  I stopped the Augmentin as she had been on the course for 5 days,  I encouraged OTC Cetirizine 10 mg daily.  Pt was advised that if any evolving difficulty with swallow, any chest discomfort or evolving shortness of breath - ER.  The patient also has a standing referral to follow-on with Urology regarding her recurrent UTIs.  I advised the patient that this may or may not be a reaction to the vaccine.
TOOK AN UNREFRIGERATED DOSE; This spontaneous case report was received from a consumer (PVX2019-562) on 04-Mar-2019. It describes a 20-year-old adult female consumer who "took an unrefrigerated dose". The consumer was receiving oral Vivotif (one capsule on every other day; lot number: 3003240) for typhoid prophylaxis.  It was reported that the consumer took the first dose of Vivotif on 03-Mar-2019 that was left unrefrigerated for 48 hours.  The action taken with Vivotif with respect to the event "took an unrefrigerated dose" was not applicable.  The clinical outcome of the event "took an unrefrigerated dose" was unknown.  Company's Comment: The causality of the event "took an unrefrigerated dose" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took an unrefrigerated dose" was considered as not applicable.
01/10/2022: Event occurred after 2nd vaccine. Patient presents to the emergency department for COVID positive failure to thrive.  Decreased p.o. intake over the last couple of days. No respiratory distress.  Diminished bilaterally without wheezes rales however fine bibasilar crackles noted.  01/12/2022: remdesivir second dose, She is on oxygen
Vaccine that administered beyond use date after the thaw process; This spontaneous case was reported by a paramedic and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 prophylaxis.     It was unknown if the patient ever had COVID positive test or diagnosis. It was unknown if patient had any acute illnesses at the time of vaccination and up to one month before. It was unknown if the patient had chronic or long-standing health conditions.     On 27-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 27-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The patient's age was reported as 27 years and 1 month.  It was unknown if any prescriptions, over-the-counter-medications, dietary supplements, or herbal remedies were being taken by the patient at the time of vaccination and/or at the time of the adverse event.  The patient did not experienced any adverse reactions after the administration of vaccine.  On 10-Jun-2022 the vaccination facility was made aware of administration of vaccines beyond use date after the thaw process after an audit was conducted   No treatment information was provided by the reporter.
ITCHY BODY; RASH ALL OVER BODY; This spontaneous report received from a patient concerned a male of unspecified age. 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: 1805029, and expiry: UNKNOWN) dose was not reported, administered on 25-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the subject experienced itchy body, and rash all over body. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the rash all over body and itchy body was not reported. This report was non-serious.
An "older" female did not seroconvert p/3 doses of Engerix-B given;
high fever, swollen face, rash in face, headache, nausea, swollen lymph nodes, joint pain, chills, weakness, overall feeling not well.
Vomiting; feeling flush; lips tingling; This is a spontaneous report from a contactable other health care professional (patient reported for herself). A 48-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6199) via an unspecified route of ad-ministration, in left arm on 12Mar2021 at 16:45 (at the age of 48-year-old) as dose 1, single for COVID-19 immunization. The patient medical history included Hashimoto, known allergy to shell-fish, red Cedar, cat hair and seasonal allergies. The patient had received other medications in two weeks (not specified). The patient previously took tetracycline and had allergy. Patient had no COVID-19 prior to vaccination and had not been tested since the vaccination. On 12Mar2021 at 19:30 PM, the patient experienced vomiting, feeling flush and lips tingling. Patient did not receive any treatment for the events. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Minor is pregnant pending OB appointment for accurate gestational age. HCG quantitative is 899 approximating gestational age to be 5-6 weeks.
Arm was red, swollen and hot to the touch. Fever/chills.  Body aches.
pt recvd flu vax & 4 days later the pt devel vertigo & nystagmus which persisted for 5 days;
dizziness; nausea; left arm pain at the site of the injection; chills; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), NAUSEA (nausea), VACCINATION SITE PAIN (left arm pain at the site of the injection), CHILLS (chills) and FATIGUE (fatigue) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Surgery. Concomitant products included ATORVASTATIN CALCIUM (LIPITOR) and LEVOTHYROXINE for an unknown indication.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced DIZZINESS (dizziness), NAUSEA (nausea), VACCINATION SITE PAIN (left arm pain at the site of the injection), CHILLS (chills) and FATIGUE (fatigue). The patient was treated with ONDANSETRON (ZOFRAN [ONDANSETRON]) for Nausea, at an unspecified dose and frequency. At the time of the report, DIZZINESS (dizziness) and NAUSEA (nausea) was resolving and VACCINATION SITE PAIN (left arm pain at the site of the injection), CHILLS (chills) and FATIGUE (fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
shaky, high BP. Evaluated by EMS-Transported to Emergency room/department or urgent care.
Vaccinated pt admitted with symptomatic covid infection. No info available on vaccine type, lot, placement, date, etc.
Left upper outer aspect of arm (at varicella vaccine site) there was raised reddened area that measured 34 mm by 25 mm. Dr. (medical director notified), no treatments ordered. Patient advised to keep rash covered while at work and while around infants/immunocompromised adults.
Reporter states pt approx 40 yrs old was vaxed w/1st dose of Hep B vax on 12SEP91; On 15OCT91 pt was hospitalized w/presumptive dx of "meningococcal illness; lab results to confirm dx were pending; MD felt exp not due to vax;
The bleeding continued after the second dose and is not stopping even with treatment by physicians; Dizziness; three days of being in bed with bad fever and nausea; three days of being in bed with bad fever and nausea; This spontaneous case was reported by a consumer and describes the occurrence of HEAVY MENSTRUAL BLEEDING (The bleeding continued after the second dose and is not stopping even with treatment by physicians), DIZZINESS (Dizziness), PYREXIA (three days of being in bed with bad fever and nausea) and NAUSEA (three days of being in bed with bad fever and nausea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included ALPRAZOLAM and TRAZODONE for an unknown indication.   On 09-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HEAVY MENSTRUAL BLEEDING (The bleeding continued after the second dose and is not stopping even with treatment by physicians), DIZZINESS (Dizziness), PYREXIA (three days of being in bed with bad fever and nausea) and NAUSEA (three days of being in bed with bad fever and nausea). At the time of the report, HEAVY MENSTRUAL BLEEDING (The bleeding continued after the second dose and is not stopping even with treatment by physicians), DIZZINESS (Dizziness), PYREXIA (three days of being in bed with bad fever and nausea) and NAUSEA (three days of being in bed with bad fever and nausea) had not resolved.            The patient did not provide her age but reported that she was in her 20s. After receiving the first dose, upon the end of the cycle of first period after the patient was having constant breakthrough bleeding. The bleeding continued after the second dose and was not stopping even with treatment by physicians. The bleeding episodes have never occurred prior to the vaccine according to the patient.   No treatment information was provided by the reporter.   This case was linked to MOD-2021-315665 (Patient Link).