chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Arthritis; I was still in some pain; The pain then went to my big toe (very severe); I still have some pain in my ankle; I think it was gout; This is a spontaneous report received from a contactable consumer or other non-health care professional (patient). A 38-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot Number: Unknown), via an unspecified route of administration, administered in Arm Left on 02Jun2021 (at the age of 38 years-old) as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, was the patient did not diagnosed with COVID-19. Since the vaccination, patient not tested for COVID-19. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot Number: Unknown), on unspecified date in 2021 (at the age of 38-yesr-old) via unknown route for COVID-19 immunisation and experienced arthralgia. Reporter stated between vaccine 1st and 2nd, On 27Jun2021, patient started feeling pain in his right ankle, which turned into severe pain. Patient went to urgent care 2 days after his second vaccine. First, they told him it was arthritis. He went back 12 days later because he was still in some pain. They ran no further tests. The pain then went to his big toe (very severe) which lasted about 2 weeks, but he still have some pain in his ankle. Patinet think it was gout, possible brought on by the vaccine. Patient visited Emergency room/department or urgent care. Treatment was received for the events as Steroids. The outcome of the events was reported as recovering.   Information on the lot/batch number has been requested.
Fever worsened; arm soreness/achy legs; minor aches and pains; Chills; slight/mild headache; fever of 100 Fahrenheit then 101.6 Fahrenheit; This is a spontaneous report from a contactable consumer.  A 68-year-old male patient received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EL3248), via an unspecified route of administration on 02Feb2021 at 09:45 at 68-years-old at a single dose for COVID-19 immunization.  Medical history included type 2 diabetes mellitus from an unknown date and unknown if ongoing.  Concomitant medications included metformin (MANUFACTURER UNKNOWN) taken for type 2 diabetes mellitus from an unspecified date to an unspecified date. The patient experienced the following events and outcomes: arm soreness/achy legs (non-serious) on 02Feb2021 with outcome of recovering, minor aches and pains (non-serious) on 02Feb2021 with outcome of recovering, chills (non-serious) on 02Feb2021 with outcome of recovered on 03Feb2021, slight/mild headache (non-serious) on 02Feb2021 with outcome of recovered on an unspecified date, fever of 100 Fahrenheit then 101.6 Fahrenheit (non-serious) on 02Feb2021 (as reported) with outcome of not recovered, fever worsened (non-serious) on an unspecified date with outcome of unknown. The clinical course was reported as follows: The patient reported having aches, pains, chills, a slight headache, and a fever of 100 Fahrenheit in the afternoon and evening on 02Feb2021 (as reported). On the morning of 03Feb2021, the patient reported having a fever of 101.6 Fahrenheit (as reported). The patient also reported a fever of 99.1-99.4 Fahrenheit (the night before the report); then, the next morning had a fever at 100 Fahrenheit and then 101.6 (as reported).The patient further reported that he had arm soreness, upon which the patient put a cold towel on it, and it was a lot better on 03Feb2021. The patient also had a mild headache and took paracetamol (TYLENOL). The patient was concerned about the fever. The patient read to drink liquids and dress lightly; and had been drinking plenty of liquids. The patient reported that his weight was 190-200 lbs. The had minor aches and pains, and he was a little achy in his legs which started on 02Feb2021 as well. At the time of the report, it was about the same. It was worse in the morning but was better now. Then the patient had a small chill the day before and at the time of the report. The patient he turned up the heat, and it went away. The was scheduled for his second dose on 23Feb2021. The doctor recommended the patient to get the vaccine because of his age and having type 2 diabetes. The patient had his diabetes under control with metformin. The patient underwent lab tests and procedures which included body temperature: 99.1 Fahrenheit on 02Feb2021, body temperature: 99.4 Fahrenheit on 02Feb2021, body temperature: 100 Fahrenheit on 02Feb2021, body temperature: 101.6 Fahrenheit on 03Feb2021.  Therapeutic measures were taken as a result of arm soreness/achy legs and slight/mild headache.
Patient was 4 years 1 month at time of vaccination and received the 5-11 year old formulation instead of the 6m-4y formula.
Provider ordered MMR for patient. Patient stated she needed. Medical Assistant gave MMR. However, when entering into electronic health record, it was discovered pt. had complete MMR series and this was a 3rd MMR.
Patient got shingles (rashes) on body 3 days after receiving vaccination. She is currently being treated with Acyclovir 800mg and PERCOCET 5/325.
Patient presents to ED with COIVD symptoms and positive test. Treated with Regeneron antibodies. Fully vaccinated April 2021.
Patient reported that a few days after getting the SHINGRIX vaccination she broke out in small comedone like pimples on her legs, stomach, and back.
Palpitations; elevated Blood pressure; high pulse rate; light headed; chills causing body shakes; trouble clearing throat; weak; chills causing body shakes; This is a spontaneous report from a contactable consumer. This 42-year-old Female consumer (patient) reported for herself.  A 42 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 22Aug2021 15:00 (Lot number: FD8448) at the age of 42 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: PALPITATIONS (non-serious) with onset 22Aug2021 15:10, outcome "recovering", described as "Palpitations"; BLOOD PRESSURE INCREASED (non-serious) with onset 22Aug2021 15:10, outcome "recovering", described as "elevated Blood pressure"; HEART RATE INCREASED (non-serious) with onset 22Aug2021 15:10, outcome "recovering", described as "high pulse rate"; DIZZINESS (non-serious) with onset 22Aug2021 15:10, outcome "recovering", described as "light headed"; TREMOR (non-serious), CHILLS (non-serious) all with onset 22Aug2021 15:10, outcome "recovering" and all described as "chills causing body shakes"; OROPHARYNGEAL DISCOMFORT (non-serious) with onset 22Aug2021 15:10, outcome "recovering", described as "trouble clearing throat"; ASTHENIA (non-serious) with onset 22Aug2021 15:10, outcome "recovering", described as "weak". The events "palpitations", "elevated blood pressure", "high pulse rate", "light headed", "chills causing body shakes", "trouble clearing throat", "weak" and "chills causing body shakes" were evaluated at the emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of palpitations, blood pressure increased, heart rate increased, dizziness, tremor, oropharyngeal discomfort, asthenia, chills.  Additional information: Patient did not had covid prior vaccination. Patient did not had covid tested post vaccination. Patient did not had any known allergies. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not receive other medications the patient received within 2 weeks of vaccination. Prior to vaccination, was the patient was not diagnosed with COVID-19. Since the vaccination, has the patient not been tested for COVID-19.  Follow-Up (08Sep2021): Follow-up attempts are completed. No further information is expected.
Next morning I felt like I'd got a rub down with a baseball bat! I hurt all over and had and still have a knot and a big red mark at the injection site!I felt very weak and had no appetite.
Bouts of profuse perspiration; Nausea; Slight headache; Extreme left arm soreness with some tingling and numbness spreading to hand; Extreme left arm soreness with some tingling and numbness spreading to hand; Extreme left arm soreness with some tingling and numbness spreading to hand; Fever of 101.0 at 12 hours post vaccination; Body aches; Malaise; Chills; Dizziness; Loss of appetite; second dose on 08Jan2021 07:15/first dose on 21Dec2020 07:15; This is a spontaneous report from a contactable other hcp (Patient). A 36-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EK9231), via an unspecified route of administration at Left arm on 08Jan2021 07:15 at single dose for COVID-19 immunization. Facility type vaccine was hospital. Medical history included hypothyroidism. No known allergies. Concomitant medication included levothyroxine sodium (LEVOTHYROXINE) 50mcg. No other vaccine in four weeks. The patient previously received first dose of BNT162B2 (lot number=EJ1685) via an unspecified route of administration at arm right on 21Dec2020 07:15 at single dose for COVID-19 immunization. The patient experienced nausea, slight headache, extreme left arm soreness with some tingling and numbness spreading to hand, fever of 101.0 at 12 hours post vaccination, body aches, malaise, chills, dizziness, loss of appetite. Adverse events start time reported as 08Jan2021 19:00. 24 hours after 2nd dose, the patient had body aches and bouts of profuse perspiration on 09Jan2021 07:15. No treatment received for these events. No COVID prior and COVID was not tested post vaccination. The patient underwent lab tests and procedures which included body temperature: 101.0 on 08Jan2021 at 19:15. The outcome of the events "second dose on 08Jan2021 07:15/first dose on 21Dec2020 07:15" was unknown, of other events was recovering.
FEVER; MUSCLE ACHES RIGHT SIDE OF THE  BODY/MUSCLE SORENESS; This spontaneous report received from a patient concerned a 30 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient was not pregnant and not breastfeeding at the time of reporting.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced muscle aches right side of the body/muscle soreness. On 06-APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on 07-APR-2021, and had not recovered from muscle aches right side of the body/muscle soreness. This report was non-serious.
sick; tiredness; muscle pain; feeling unwell; headache; body aches; like flu; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 34-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN (non-serious) with onset 30Sep2023, outcome "recovering", described as "body aches"; HEADACHE (non-serious) with onset 30Sep2023, outcome "recovering"; INFLUENZA (non-serious) with onset 30Sep2023, outcome "recovering", described as "like flu"; ILLNESS (non-serious), outcome "recovering", described as "sick"; FATIGUE (non-serious), outcome "unknown", described as "tiredness"; MYALGIA (non-serious), outcome "unknown", described as "muscle pain"; MALAISE (non-serious), outcome "unknown", described as "feeling unwell".  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Per mother, next day patient had T max 104.3 F with rigors/chills and extra sleepy/difficulty to arouse. Brought to ED. Later patient had nausea. Mother educated about fever management and when to go to ED. Patient came back to Peds clinic for evaluation 4/4/13. Reaction resolved.
CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient through other manufacturer (Pfizer) concerned a 60 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: ulcerative colitis, and the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of administration, batch number were not reported, expiry: unknown) dose was not reported, 1 in total was administered on 05-APR-2021 to left arm for covid-19 prophylaxis. The batch number was not reported and has been requested. The age at time of vaccination 59 years old. Concomitant medications included balsalazide sodium. The patient received non-company suspect vaccine elasomeran (Moderna Covid-19 vaccine) (dose number in series 2) (form of admin, route of admin, and batch number were not reported, expiry: unknown) dose was not reported, administered on 27-OCT-2021 to left arm for covid-19 prophylaxis. It was unknown whether patient had any adverse events following elasomeran (Moderna Covid-19 vaccine) (dose number in series 2). The patient received non-company suspect vaccine elasomeran (Moderna Covid-19 vaccine) (dose number in series 3) (form of admin, route of admin, and batch number were not reported, expiry: unknown) dose was not reported, administered on 18-APR-2022 to left arm for covid-19 prophylaxis. On 29-JUN-2022, the patient was treated with non-company suspect drug Paxlovid (form of admin, route of admin and batch number were not reported, expiry: unknown) dose and frequency were not reported for covid-19 treatment and last administered on 3-JUL-2022. On 04-JUL-2022, after non company suspect drug paxlovid treatment (for covid-19) laboratory data included: COVID-19 home antigen test Negative.  On 08-JUL-2022, the patient was rebounded with COVID-19 and tested positive for coronavirus disease-19 polymerase chain reaction (COVID-19 PCR) test which was coded confirmed covid-19 infection (dose number in series 3) and confirmed clinical vaccination failure (dose number in series 1). On 09-JUL-2022, the patient experienced runny nose (dose number in series 3). The action taken with covid-19 vaccine ad26.cov2.s, and elasomeran was not applicable and paxlovid was drug discontinued on 03-JUL-2022. The patient had not recovered from confirmed covid-19 infection, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint, and reference number requested.; Sender's Comments: V0-20220732582 -COVID-19 VACCINE Ad26.COV2.S- Confirmed clinical vaccination failure. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
NO ADVERSE EVENTS OCCURED,  Patient received a monovalent COVID-19 product after 4/18/23. Appropriate next steps will be taken based on Interim Clinical Considerations for Use of COVID-19 Vaccines.
This spontaneous report as received from a registered nurse refers to a 12 month old patient of unknown gender. Medical history was not reported. On 27-MAY-2014 the patient was vaccinated with M-M-R II (0.5 ml, subcutaneously, dose number, anatomical location, lot number was not reported). Other suspect therapies included PROQUAD. Concomitant medications were not reported. On 27-MAY-2014 the patient was inadvertently administered a 0.5 ml dose of experienced inadvertently administered a 0.5 ml dose of PROQUAD and a 0.5 ml dose of M-M-R II. No adverse effects reported. Additional information has been requested.
VERTIGO, HEADACHE, NAUSEA, WEAKNESS, VISUAL DISTURBANCE (BLURRY DISTANCE.
Pt already recievd a Moderna Bivalent vaccine 10/2023. Today she was given a second.
major hives issues; outbreaks of hot spots; irritation on her skin; swelling of the face; So there has been rashes; Irritation on Face; Irritation on Face and Stomach; This is a spontaneous report received from contactable reporter(s) (Other HCP) from medical information team. The reporter is the parent.  A 10 year-old female patient received bnt162b2 (BNT162B2), administration date 11Dec2021 (Lot number: FC0007) at the age of 10 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "dry skin" (ongoing); "Asthma" (ongoing). Concomitant medication(s) included: FLOVENT taken for asthma (ongoing); ALBUTEROL [SALBUTAMOL] taken for asthma (ongoing). The following information was reported: URTICARIA (medically significant), outcome "not recovered", described as "major hives issues"; FEELING HOT (medically significant), outcome "not recovered", described as "outbreaks of hot spots"; SKIN IRRITATION (medically significant), outcome "not recovered", described as "irritation on her skin"; SWELLING FACE (medically significant), outcome "not recovered", described as "swelling of the face"; RASH (medically significant), outcome "not recovered", described as "So there has been rashes"; SKIN IRRITATION (non-serious), outcome "not recovered", described as "Irritation on Face"; EPIGASTRIC DISCOMFORT (non-serious), outcome "not recovered", described as "Irritation on Face and Stomach". The events "major hives issues", "outbreaks of hot spots", "irritation on her skin", "swelling of the face", "so there has been rashes", "irritation on face" and "irritation on face and stomach" were evaluated at the physician office visit. Treatment included Benadryl, Zyrtec, Cetirizine Hydrochloride Antihistamine, Prednisone 5mg tablets: take 4 tablets by mouth twice a day for 3 days, then 2 tablets twice a day for 3 days, then 2 tablets by mouth once daily for 2 days, then 1 tablet 1 daily for 2 days.  Clinical course: reported stated that patient was on Steroid and was done the end of last week and patient is starting to have issues with hives again. Patient did not had history of all previous immunization with the Pfizer vaccine considered as suspect and was not administered additional vaccines on Same Date of the Pfizer Suspect. Adverse Event onset time reported as 7-10 Days Later. Patient did not had Prior Vaccinations within 4 weeks. AE reported prior vaccinations are normal redness injection site and mild fever when patient was little with typical vaccines (not specified). Family Medical History Relevant to AE reported as None. No relevant tests are reported.  Follow up (31Jan2022): This is a spontaneous follow up report from a same contactable other HCP. This other HCP reported for a 10-Years-Old female patient that: Updated information: reporter phone no. mail id, patient address, RMH, Suspect product dose no, facility name Event, event outcome, physician office  No follow-up attempts are needed. No further information is expected.
Migraine onset 3.5 weeks post shot. Continuing 10 days and counting. I have a history of migraine but usually a day or two it dissipates. I visited a pain specialist MD on  4/26/21 and was given an injection of anti inflammatory medication which didn?t relieve migraine. On 4/27/21 I visited the ER and was given two liters of fluid along with more anti inflammatory and steroids. Headache only slightly better than  prior to treatment. Feeling of head fullness and pain continues.
I couldn't have it a headache every day; I am having it every day and it's not all days it's just cut and comes on; This is a spontaneous report received from a contactable consumer (patient). A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: unknown, and Expiration date: unknown), via an unspecified route of administration on an unspecified date in Feb2021 as 1ST dose single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient reported that I couldn't have it a headache every day since I took the vaccine last week, it was last Friday so do I need to report that or give it a few more days. Treatment: patient stated, No, I am having it every day and it's not all days it's just cut and comes on. The patient did not receive any treatment for event. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Lots of pain in left arm. Can't extend the left arm or reach without being in pain.
Received a refreeze vaccine once thawed; Received a refreeze vaccine once thawed; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Received a refreeze vaccine once thawed) and PRODUCT STORAGE ERROR (Received a refreeze vaccine once thawed) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 084J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 16-Apr-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Received a refreeze vaccine once thawed). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Received a refreeze vaccine once thawed). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Received a refreeze vaccine once thawed) and PRODUCT STORAGE ERROR (Received a refreeze vaccine once thawed) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided. Reportedly, a thawed shipment of vials of the Moderna COVID-19 vaccine were received. Once received, they placed the shipment on the refrigerator except for 1 vial, that was stored on the freezer. The vial was again thawed and then administered to 4 patients in the facility. The doses applied were 2 second boosters and 2 first boosters on the 16Apr2022. No temperature excursions was observed.  No treatment medication was provided.   This case was linked to MOD-2022-545266, MOD-2022-545272, MOD-2022-545269 (Patient Link).
I was pregnant at the time I got the first vaccine. The pregnancy was conceived on March 10. On the date I received the vaccine I was 5 weeks 6 days. When I  got my first ultrasound at 7 weeks, it revealed that the baby measured 6 weeks, 1 day, and there was no heartbeat. A second ultrasound at 9 weeks, revealed the same development: 6 weeks 1 day. This seems to show that the baby passed away two days after receiving the moderna vaccine.
Mom reported pt to be quite fidgety & sleepy p/DTP pt recvd no treatment;
AT 4:30 PM PATIENT DEVELOPED A FEVER AND DIFFUSE REDNESS IN THE LEFT ARM.
PATIENT WAS ADMINISTERED 0.3ML OF UNDILUTED PFIZER VACCINE. PT WAS OFFERED AN MD EVALUATION TO INCLUDE AN EKG AND TROPONIN LEVEL. PT HAS A HISTORY OF HTN. PT REPORTED PAIN AT SITE, MIGRANE AND HTN DUE TO PREGNANCY. SHE IS TO HER HER OB TODAY.  NO ESTIMATED DATE OF DILVERY AVAILABLE.
Moderna COVID-19 Vaccine EUA. Sharp pain in upper right side. believe to be gallbladder issue because pain increaased after eating. Did not see doctor. Pain was intermittant. lasted approx 3 days.
Patient felt nauseous, cold and chills.  When asked to sit or stand legs gave out (had no control over leg movement).  EMS was called on site and patient was taken to the hospital.
p/vax pt devel a fever & hives;this was followed by confusion & rage accompanied by destructive behavior & similar actions;