chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Hard to lift arm; elevated heart rate; warm; little bit of swelling at the injection site; Super painful; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MOBILITY DECREASED (Hard to lift arm), HEART RATE INCREASED (elevated heart rate), INJECTION SITE WARMTH (warm), INJECTION SITE SWELLING (little bit of swelling at the injection site) and VACCINATION SITE PAIN (Super painful) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     The patient's past medical history included No adverse effect.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Jan-2021, the patient experienced MOBILITY DECREASED (Hard to lift arm), HEART RATE INCREASED (elevated heart rate), INJECTION SITE WARMTH (warm), INJECTION SITE SWELLING (little bit of swelling at the injection site) and VACCINATION SITE PAIN (Super painful). At the time of the report, MOBILITY DECREASED (Hard to lift arm), HEART RATE INCREASED (elevated heart rate), INJECTION SITE WARMTH (warm), INJECTION SITE SWELLING (little bit of swelling at the injection site) and VACCINATION SITE PAIN (Super painful) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
chills; temperature and it was 101.4°F; This is a spontaneous report from a contactable consumer (Patient, Self-reported). A 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiration date were not reported) dose 1 via an unspecified route of administration on 27Jan2021 (at the age of 67-years-old), as SINGLE for Covid 19 Immunisation. She stated that she was fine all day yesterday and this morning on 28Jan2021, at 10:00 am, she had experienced chills and stated that they went away. She further stated that she recently checked her temperature and it was 101.4 degree fahrenheit. The patient would like to know whether her symptoms were normal and how long will her symptoms would last. The patient underwent lab tests and procedures which included body temperature 101.4 degree fahrenheit in Jan2021. The outcome of the event chills was resolved and outcome for pyrexia was unknown.  Information about lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
THREW A BLOOD CLOT IN HEART; OFF LABEL USE; DRUG USE FOR UNAPPROVED DOSING REGIMEN; This spontaneous report received from a patient via social media (Facebook) concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN and expiry: UNKNOWN) dose, start therapy date were not reported, 2 total administered for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. On an unspecified date, the patient got the second J&J Covid shot (off label use and drug use for unapproved dosing regimen), and experienced a blood clot in heart. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from threw a blood clot in heart, and the outcome of off label use and drug use for unapproved dosing regimen was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: This report received via social media concerns a female of unspecified age and race/ethnicity who "threw a blood clot in her heart" an unspecified time after receiving a second Janssen Covid-19 vaccination. Medical history, concomitant medications, diagnosis, latency, diagnostic testing, corrective treatments, and outcome were not reported. At this time, this case does not appear to be consistent with recently reported Thrombosis with Thrombocytopenia Syndrome following Covid-19 vaccine administration. In light of missing information (medical history, concomitant medications, diagnosis, latency, diagnostic testing to clarify the type of clot, platelet counts, anti-PF4 antibody, tests for hypercoagulability, corrective treatments), the relationship with Janssen Covid-19 vaccine is considered unclassifiable.
LARGE RED AREA ABOUT 4 X 6 INCH AROUND THE INJECTION SITE. SHE DID STATE THAT SHE HAD A SLIGHT FEVER YESTERDAY AS WELL.
Sore arm began 2.5 hours after vaccination. Migraine attack occurred 5.5 hours after vaccination. Sore arm dissipated on day 4-5. On day 8 the sore arm returned and I got another migraine attack. I normally get 0-2 migraines per week, and in the two weeks since I have gotten the first shot my attacks have more than tripled. In my entire life, I have never had such a dramatic increase of attacks.
"Approximately 2 hours after receiving the vaccine the employee broke out in hives with blisters. The hives progressed to multiple body parts. This employee was treated and was referred to an allergist for continued treatment.  A latex rast was performed and was negative.  The employee has remaining reddened areas but with treatment the itching has subsided." no further information was provided.
pt recvd vax 17OCT sxs morning of 18OCT nausea & vomiting p/eating breakfast, body aches, fatigue improved throughout day, still has lt sided joint pain;took ASA helped w/body aches
chills; nausea; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 28-year-old female patient received BNT162b2 (BNT162B2), on 12Jan2021 as dose 2, single (Lot number: EL1284) at the age of 28 years for covid-19 immunisation. The patient's relevant medical history included: "Polycystic ovarian syndrome" (ongoing); "Rosacea" (ongoing); "Supraventricular tachycardia" (unspecified if ongoing). Concomitant medication(s) included: INTRAUTERINE CONTRACEPTIVE DEVICE. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot number: EH9899), administration date: 24Dec2020, when the patient was 28-year-old, for Covid-19 immunization. The following information was reported: CHILLS (non-serious) with onset 13Jan2021, outcome "recovered" (Jan2021); NAUSEA (non-serious) with onset 13Jan2021, outcome "recovered" (Jan2021). Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient also received BNT162b2 (BNT162B2), on 02Nov2021 as dose 3 (booster), single (Lot number: EW0187) in left arm for covid-19 immunisation. Agent stated had caller on the line who received the Purple Cap Formulation of the Pfizer BioNTech Covid Vaccine as a Booster on 02Nov2021 and experienced swelling under arm pit and shooting pain down arm. Caller reported after the second dose, 24 hours later she had chills and nausea that came on and went away quickly.; Sender's Comments: Linked Report(s) : PFIZER INC-202201391914 same reporter/pt, different dose/event;
Janssen COVID-19 vaccine EUA on 04/07/2021 and tested positive via nasal swab PCR on 5/29/2021
PT HAS NO HISTORY OF SEIZURE BUT HAD A SEIZURE A FEW MINUTES AFTER RECEIVING BOTH VACCINATIONS
This is a spontaneous report from a contactable consumer (patient). A 45-year-old (non-pregnant) female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# unknown), at the age of 45, via an unspecified route of administration, right arm, on Apr 14, 2021, at 14:45, single dose, for COVID-19 immunisation. The patient has not reported any other health issues. The patient has no known allergies to medications, food or other products. Prior to the vaccination, patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Concomitant medications included omeprazole and Biotin; both from an unknown date for unknown indication. On Apr 14, 2021, at 14:45, patient's tongue felt like it was swollen-up, unable to swallow, metallic/medicine-like taste and tingling lips. It lasted about 8 minutes, then got a little better but still hard to swallow and lips were tingling for a few hours. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures taken as a result of reported events included treatment with OTC Benadryl (diphenhydramine). Since the vaccination, patient has not tested for COVID-19. The outcome of tongue felt like it was swollen-up, unable to swallow, metallic/medicine-like taste and tingling lips recovered on an unknown date in Apr 2021. No follow-up attempts needed. Information about lot/batch number cannot be obtained.
Red rash over abdomen, arms, and legs.  Rash was not itchy and was not raised. Patient was seen by a physician the next day and was given a steroid shots and cream. Patient stated that it took about a week for the rash to subside.
With no allergies to eggs, I developed hives that benedryl could not take care of.  I work at the clinic it was given at and had gotten my shot at the start of my shift which was about 3:30 p.m.  I started feeling itchy on the upper part of my body within a couple of hours.  I did not realize what was actually going on until I had gotten home and getting ready for bed and saw that I had broke out in hives all over which were becoming more and more prevalent and noticeable.  I then took benedryl before I went to sleep; however, when I awoke I had found that i had gotten worse even with using the benedryl.  I then had gone back to the clinic in Urgent care in order to get some sort of treatment.  I was then treated with a shot of Prednisone and was given zyrtec to take for the week.
Expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 75-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 05-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided    For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medications were reported.
On 12/29 I developed COVID-19 symptoms. I did a tele-health visit w/ my Dr.  I was prescribed a Spiriva inhaler and Ventolin and a cough. I believe I have the symptom of occasional confusion as described w/ long COVID-19 and occasional fatigue.
The vial expired on 01-Apr-2022 that was initially stored in the refrigerator on 04-Apr-2022 and then administered on 19-Apr-2022; Expired vaccine administered to patient; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patient) and PRODUCT STORAGE ERROR (The vial expired on 01-Apr-2022 that was initially stored in the refrigerator on 04-Apr-2022 and then administered on 19-Apr-2022) in a 92-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 19-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patient). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial expired on 01-Apr-2022 that was initially stored in the refrigerator on 04-Apr-2022 and then administered on 19-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patient) and PRODUCT STORAGE ERROR (The vial expired on 01-Apr-2022 that was initially stored in the refrigerator on 04-Apr-2022 and then administered on 19-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The vial was initially stored in the refrigerator on 04-Apr-2022.   The pharmacist reported that vaccine expired in Jun-2022 however the vaccine expired on 01-Apr-2022. The vial had not undergone any temperature excursions. The pharmacist does not have any other information on the patients at that time and would call Moderna when additional information was known. The health care professional further stated to provide missed information and mentioned that 155 patients were vaccinated with expired doses from 02-Apr-2022 to 19-Apr-2022.  No treatment medications were reported.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No concurrent conditions or medical history were provided. On an unspecified date in 2016 (reported as "on or after 03-MAR-2016"), the patient was vaccinated with an improperly stored dose of ROTATEQ injection (lot # M002252 with expiry date: 28-FEB-2017, orally; strength, dose and site of administration were unspecified). Concomitant therapy was not reported. The administered vaccine underwent the temperature excursion at 8.3 degrees Celsius for 19 minutes. There was no previous temperature excursion. It was a case of a "data logger". No adverse effect was reported. This is one of several reports from the same source. Additional information has been requested.
Arm/shoulder/back pain despite mult. analgesics and interfering w/ADL's; >1 mo.
Patient reported severe body ache, lack of energy and runny nose. She's been tired and has been sleeping. Even though these adverse events are generally seen after second dose, we are reporting this because the vial was at room temperature for about 31 hours, but still within recommended range by Pfizer's 36 hours at room temperature.
Tingling in the fingertips of my right hand; Lose the strength in my arm; Driving or holding my 6 month old niece was very concering; Pain; Internal tremors like painful jack hammer vibration inside my arm; Numbness in arm 10%; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Internal tremors like painful jack hammer vibration inside my arm), HYPOAESTHESIA (Numbness in arm 10%), PARAESTHESIA (Tingling in the fingertips of my right hand), MUSCULAR WEAKNESS (Lose the strength in my arm) and IMPAIRED DRIVING ABILITY (Driving or holding my 6 month old niece was very concering) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     no medical history was provided by reporter.  Concomitant products included METFORMIN, LISINOPRIL, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) and POTASSIUM CHLORIDE for an unknown indication.    On 16-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 2 dosage form. On 16-Mar-2021, the patient experienced TREMOR (Internal tremors like painful jack hammer vibration inside my arm) and HYPOAESTHESIA (Numbness in arm 10%). On an unknown date, the patient experienced PARAESTHESIA (Tingling in the fingertips of my right hand), MUSCULAR WEAKNESS (Lose the strength in my arm), IMPAIRED DRIVING ABILITY (Driving or holding my 6 month old niece was very concering) and PAIN (Pain). At the time of the report, TREMOR (Internal tremors like painful jack hammer vibration inside my arm), HYPOAESTHESIA (Numbness in arm 10%), MUSCULAR WEAKNESS (Lose the strength in my arm), IMPAIRED DRIVING ABILITY (Driving or holding my 6 month old niece was very concering) and PAIN (Pain) outcome was unknown and PARAESTHESIA (Tingling in the fingertips of my right hand) had resolved.            Patient put a coin at her arm which has vibration feeling and it sticked to the arm.  Most of the tremors have stopped but she is  still have tingling in the fingertips of her right hand. The duration of this unpleasantness was the months of April, May and beginning of June. The tremors were painful and would cause her to have to stop whatever she was doing due to the fact that she  would lose the strength in her arm. Driving or holding her 6 month old niece was very concering and  she had to grip tightly with her left arm and hand in order not to drop things. The tremors would occur as a slight tingle and would increase intensity until it would cause pain. They occurred 30 to 40 times a day. They mostly subsided the end of may.  Treatment medication was not provided    This case was linked to US-MODERNATX, INC.-MOD-2021-024525 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 09-Jul-2021: Frequency updated  for the event tremor in in event tab I  narrative supplement added; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-024525:First dose case
After immunization visit, mom took child home and he took a nap. When child awoke mom thought child felt warm to touch but did not take temperature. Mom gave child Motrin. Mom noticed swelling of Rt. arm from shoulder to elbow that afternoon. Child playing when mom called. No c/o discomfort from child.
Minutes after vaccination patient reported feelings of lethargy, light headedness, and unable to focus. He instructed patient to sit and relax for 30  minutes. Prior to completion of 30 minutes, patient felt he might lose consciousness and we administered an ammonia smelling packet. Patient was more alert but still feeling symptoms. We had patient eat crackers and orange juice. After 15 additional minutes patient reported feeling normal and okay to leave.
This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 20-Jan-2023 and administered the vaccine on 14-Feb-2023) and NO ADVERSE EVENT (No adverse event) in an 8-month-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1414B) for COVID-19 prophylaxis.     It was reported that patient does not had any allergies.     On 14-Feb-2023, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 14-Feb-2023,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 20-Jan-2023 and administered the vaccine on 14-Feb-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 20-Jan-2023 and administered the vaccine on 14-Feb-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.
MANUFACTURER RECALL BASED ON PRODUCT STABILITY.  PATIENT HAS NOT REPORTED AN ADVERSE REACTION TO US.
pt recv vax;HA, v, fever started about 28 hr p/ vax;tx w/ apap;
Information has been received from a physician concerning a 10-week-old male who was vaccinated PO with the first dose of Rotateq. The physician reported that, shortly after vaccination, the patient developed persistent diarrhea. Unspecified medical attention was sought. The physician indicated that he was planning to run tests (not further specified) to determine if the diarrhea is related to Rotateq. At the time of this report, the outcome was unknown. Additional information has been requested.
the pt received a dose that was not diluted properly.  The vial was diluted with 0.18 ml instead of 1.8ml.   The dilution error was discovered shortly after administration and a call was made to the patient immediately.  The patient was asked to return to the pharmacy for observation. The patient wouldn't agree to return and chose to self monitor along with his parents who were present with him at the time.   The patient did not indicate or state any adverse reaction had occurred.
Fever; headache; tachycardia; left arm pain; muscle pain; stomach upset; This is a spontaneous report received from a contactable nurse (patient). A 25-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection and lot number: EL9282) at the age of 25 years intramuscularly to left arm on 28Jan2021 13:00 at single dose for Covid-19 immunisation in hospital. Medical history included Kyphosis. The patient had no known drug allergy (NKDA). The patient had no concomitant medications. Patient previously the first dose of BNT162B2 at the age of 25 years for Covid-19 immunisation. The patient did not receive other vaccine in four weeks. The patient was not pregnant. The patient did not have COVID prior to vaccination. The patient underwent nasal swab (antigen) test on 20Jan2021 with negative result. On 28Jan2021 16:00 the patient experienced fever, headache, tachycardia, left arm pain, muscle pain and stomach upset. Therapeutic measure was taken as a result of the events and included treatment with PANADOL 500mg. Outcome of events was recovering.  No follow-up attempts are possible. No other information was reported.
pain; 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), on 15Sep2021 as dose 2, single (Lot number: FC3183) intramuscular, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hypo" (ongoing); "Chronic pain" (ongoing); "CKD3" (ongoing). Concomitant medication(s) included: THYROID TINCTURE oral taken for hypothyroidism (ongoing). Vaccination history included: BNT162b2 (Dose: 1st, Time: 12:00 PM, Route of administration: Intramuscular, Anatomical Site of injection: Left upper arm, Lot: FC3183), administration date: 26Aug2021, for COVID-19 Immunization, reaction(s): "Pain". The following information was reported: PAIN (non-serious) with onset 15Sep2021, outcome "not recovered". The event "pain" required physician office visit. Therapeutic measures were not taken as a result of pain.  Additional information: The second dose of vaccine was administered on Right upper arm. No relevant tests were done. Specific relevant test for thromboembolic events with thrombocytopenia: None.
On March 30th the patient had loss of appetite and headache.  On March 31st the patient collapsed and was taken to the ER, the patient's oxygen was low.  Patient's blood pressure had dropped and you could not wake him up all afternoon.  The Ambulance took him to the hospital on April 1st where he had shortness of breath and blood clots in lungs.  On April 1-2  the patient was leaking blood but the hospital staff could not find where so they gave him 3 units of blood.  Patient also received 3 antibiotics for a rare pneumonia.
Hives, initially over all of body, resolved after 4 hrs with benadryl, then migratory for about 1 day
Pt. Has history of vasovagal syncope w/ injections. Pt. received injection and experienced vasovagal syncope Incident about 5 minutes after vaccine. Pt was transferred in wheelchair to treatment area/bed. Pt. Regained consciousness about 30 seconds after episode. Pt. was evaluated by Dr. Pt. was A/O x4. 4 sets of vitals obtained with improvement after each set.