chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Donated blood one week after receiving both doses of the vaccine; Doses administered less than one month apart; A spontaneous report was received from a consumer, who was a 67 year-old, male patient, who received both doses of Modern's COVID-19 vaccine (mRNA-1273) less than one month apart and donated blood one week after receiving second dose of the vaccine.   The patient medical history was not provided. No relevant concomitant medications were provided.   On 20-Jan-2021, the patient received their first of two planned doses of mRNA-1273 (Batch number not provided) .   On 10-Feb-2021, the patient received their second of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly for prophylaxis of COVID-19 infection.   Both doses administered less than one month apart.   On 19-Feb-2021, the patient donated blood one week after receiving second dose of the vaccine.   No treatment information was provided.  The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event is not applicable.   The outcome of the events, doses administered less than one month apart and donated blood one week after receiving second dose of the vaccine, were considered resolved on 19 Feb 2021.; Reporter's Comments: This report refers to a case of inappropriate schedule of product administration for mRNA-1273, unknown lot,  with no associated AEs.
Chills, temperature 101 degrees, nausea, exhaustion, somewhat elevated heart rate. Symptoms were worst during first day, continued until day 3.
Heart issues; Lung issue; Patient experienced all symptoms that come with it; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC DISORDER (Heart issues), LUNG DISORDER (Lung issue) and IMMUNISATION REACTION (Patient experienced all symptoms that come with it) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CARDIAC DISORDER (Heart issues), LUNG DISORDER (Lung issue) and IMMUNISATION REACTION (Patient experienced all symptoms that come with it). At the time of the report, CARDIAC DISORDER (Heart issues), LUNG DISORDER (Lung issue) and IMMUNISATION REACTION (Patient experienced all symptoms that come with it) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  The patient started treatment on an unspecified date with Moderna COVID-19 Vaccine at an unspecified dose.  It was reported the patient experienced all symptoms that come with it, including heart issues and lung issues.  No treatment medications were reported.
seeing black moving spots in my right eye; jaw & neck are achy on my right side; jaw & neck are achy on my right side; This is a spontaneous report from a contactable consumer (patient). A 61-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: ER8737), via an unspecified route of administration, administered in arm left on 19Apr2021 at 13:45 (at an age of 61-years-old) as dose1, single for covid-19 immunization. Medical history included hysterectomy on an unspecified date in 2011. Patient was not diagnosed with covid-19 prior to vaccination. Concomitant medications included Calcium (MANUFACTURER UNKNOWN), via an unspecified date on an unspecified date at unknown dose and frequency for unknown indication; levothyroxine, liothyronine (NP THYROID) (MANUFACTURER UNKNOWN), via an unspecified date on an unspecified date at 60 mg, unknown frequency for unknown indication; vitamin d3 (VITAMIN D3) (MANUFACTURER UNKNOWN), via an unspecified date on an unspecified date at unknown dose and frequency for unknown indication; cyanocobalamin (VITAMIN B12 AAA) (MANUFACTURER UNKNOWN), via an unspecified date on an unspecified date at unknown dose and frequency for unknown indication; fish O (MANUFACTURER UNKNOWN), via an unspecified date on an unspecified date at unknown dose and frequency for unknown indication. The patient previously took ampicillin for hypersensitivity and experienced allergy. Patient did not received any other vaccine prior four weeks of vaccination. On 20Apr2021 at 17:00, the patient experienced seeing black moving spots in my right eye since tuesday evening and jaw & neck are achy on my right side. Since vaccination patient not tested for covid-19. No therapeutic measures were taken as a result of the events. The clinical outcome of the seeing black moving spots in my right eye, jaw & neck are achy on my right side were not recovered.  Batch/Lot number was obtained. Further information has been requested.
Patient received #2 VZV, #1 HPV, and #1 Tdap (had 5 previous DTP vaccines) 4-1-09 at the HC. At the OV on 4-1-09 patient also had a viral gastroenteritis, was afebrile.  While away, early AM on 4-4-09 patient developed a rash and SOB, taken to ER and diagnosed with "urticaria". Previous to rash child had been eating Cheetos and red Gatorade.   Returned to the HC 4-9-09 to see Dr. for re-check ER visit.  No symptoms or rash at recheck appointment.
Patient reported having erythema during an 8/9/2019 primary care visit. The patient visited the vaccine back in October of 2018. The patient has already gotten both the vaccines in the series.  & Erythema
Abdominal cramps and nausea started 5 days after shot 2 of Pfizer resulting in appendicitis requiring emergency surgery to remove the appendix.
Friday 4/9/2021- Nausea, Upper Body Pains (arms, chest, upper back, neck, stomach), Dizziness, unable to walk, fatigue, headache. Saturday 4/10- Same symptoms with little to no improvement Sunday 4/11- Same symptoms with minor improvement Monday 4/12- Same symptoms with no improvement, increased pains, dizziness, fatigue with headache and facial pain in eyes, cheeks, jaw, ear, nose, and back of neck, primarily on left side of face.  Tuesday 4/13- Same symptoms, No improvements, increased nausea with severe headaches and facial pains Wednesday 4/14- Same symptoms, with diarrhea. Thursday 4/15- Ongoing same symptoms, little improvement with Tylenol. Less upper body pains, and nausea. Off and on facial pain and headaches but with facial numbness when without the pain. Dizziness while standing. Diarrhea has ceased. Still weak/fatigue.
pt reports exp lt upper arm muscle deterioration w/pain (inc w/movement), itching & a red streak around the inj site p/vax;w/in a month pt noted itching, burning, redness, 2 red streaks on arm;arm sink in place @ inj site;
Fell flat on my stomach, face first; After about 30  minutes I felt the surface descending  and my walk pace increased; Finally I fell forward on my face; Suddenly felt like I was walking down a hill, I was descending. The street was flat.; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (Fell flat on my stomach, face first), GAIT DISTURBANCE (After about 30  minutes I felt the surface descending  and my walk pace increased) and FALL (Finally I fell forward on my face) in an 88-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Prostate cancer since 01-Jul-1996 and Cane user. Concomitant products included LEUPRORELIN ACETATE (LUPRON) for an unknown indication.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Apr-2021, the patient experienced MUSCULAR WEAKNESS (Fell flat on my stomach, face first) (seriousness criterion hospitalization), GAIT DISTURBANCE (After about 30  minutes I felt the surface descending  and my walk pace increased) (seriousness criterion hospitalization), FALL (Finally I fell forward on my face) (seriousness criterion hospitalization) and FEELING ABNORMAL (Suddenly felt like I was walking down a hill, I was descending. The street was flat.). The patient was hospitalized from 07-Apr-2020 to 08-Apr-2020 due to FALL. The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at a dose of 2 UNK. At the time of the report, MUSCULAR WEAKNESS (Fell flat on my stomach, face first), GAIT DISTURBANCE (After about 30  minutes I felt the surface descending  and my walk pace increased), FALL (Finally I fell forward on my face) and FEELING ABNORMAL (Suddenly felt like I was walking down a hill, I was descending. The street was flat.) outcome was unknown.            Company Comment: 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.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: Follow up received medical history, concomitant medications and events were added and reporter information was updated and 1st dose details were updated.; Sender'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.
Patient went to the doctor to get treatment after recommendation from me the pharmacist.  Patient complained of severely swollen arm the is red, sore and hot to the touch.
It was noted at this child's 2 year well that he had received TDAP instead of DTAP at his 18 month well visit. This is a pediatric office.  Product was checked by two people, but neither person caught that it was the wrong drug.  Actual product was BOOSTRIX and TRIPEDIA.  Per the CDC this would still count as the 4th dose and child should be given 5th dose at 4-6 years.  More care should have been taken when checking the vial for correct drug.
Received Moderna 1/13/2021, began having poor appetite, loose stools on 1/24/2021.  On 1/31/2021 patient had dry cough, fever, shortness of breath, body aches, lethargy and was admitted to the hospital.
Patient developed large red swollen area on upper arm, warm to the touch. Reported no itching or burning.
had both shingle shots/ shingles/ suspected vaccination failure; shingles dark blotchy; dark blotchy; shingles dark; This case was reported by a consumer via Shingrix interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, blotchy and darkened skin. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles, blotchy and darkened skin were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, blotchy and darkened skin to be related to Shingles vaccine and Shingles vaccine.  Additional details were reported as follows: This case was reported by the patient. The age at vaccination was not reported. The patient received both Shingles shot and have what looks to shingles dark blotchy. The patient stated no pain was there. The patient asked anything to do or take to make shingles go away. This case was considered to be a suspected vaccination failure case, as the details regarding laboratory confirmation for shingles and time to onset were unknown.
Information has been received from a Certified Medical assistant (C.M.A) concerning a 67 year old male patient with hyperlipidaemia, coronary artery disease and peripheral vascular disorder who on 24-JUL-2007 was vaccinated IM into the left arm with a first dose of PNEUMOVAX 23, lot # 654977/0888F. Concomitant therapy included simvastatin (MSD), NORVASC, ALTACE, AXID, PLAVIX and TOPROL XL TABLTS. The reporter reported that the patient's wife called the office "2 weeks ago" to say that her husband had arm pain since he received the PNEUMOVAX 23. He also had redness and warmth at the injection site after the injection. No other information available at this time. The outcome was unknown. Additional information has been requested.
CROHN'S DISEASE FLARE UP; pain; This is a solicited report from a contactable consumer (patient) based on the information received by Pfizer (Mfr. Control Number: 21K-163-3906742-00). A 46-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 intramuscular on an unspecified date (Batch/Lot number was not reported) as 2nd dose, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at unspecified dose for Moderate to Severe Adult Crohn's Disease. Patient previously received 1st dose COVID-19 Vaccine (BNT162B2) for COVID-19 immunisation on unknown date.  The patient medical history was not reported.  The patient's concomitant medications were not reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The patient experienced crohn's disease flare up and pain on an unspecified date with outcome of unknown. The reporter reported the events as non-serious. The action taken in response to the events for bnt162b2 was not applicable, for adalimumab was unknown.  Causality for HUMIRA(ADALIMUMAB): The reporter's causality for the events of CROHN'S DISEASE FLARE UP and PAIN was not provided. Causality for bnt162b2: the reporter considered the event Crohn's disease aggravated was possibly related to bnt162b2, causality for event pain was not reported.  The reporter's assessment of the causal relationship of the event pain with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: A causal association between BNT162B2 and pain cannot be completely excluded based on temporal association and the limited information provided in the report. The reported Crohn's disease flare up is likely due to an underlying medical condition and unrelated to BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product 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 RAs, Ethics Committees, and Investigators, as appropriate.
Patient received expired vaccine.  Was administered 3/4/2023, IPV expired /272/2023.  Patient was notified and instructed to notify medial facility if they experience any adverse reactions.
Redness, swollen, painful rash at my left arm - as big as a fist.
Hives on eyelids; Itchy eyes; Muscle soreness; Joint pain; Fever; Sweats; Mild headache; Sore arm; Tired; Dizziness; Nauseous; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the left arm on 15Apr2021 at 12:30 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. Medical history included Graves' disease. The patient previously took methocarbamol (MANUFACTURER UNKNOWN) and cyclobenzaprine (MANUFACTURER UNKNOWN) for unknown indication and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included citalopram (MANUFACTURER UNKNOWN), vitamin d nos (VITAMIN D) and selenium sulfide (SELENIUM); all taken from unknown dates for unknown indications and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 15Apr2021 at 12:30, immediately after the vaccine, patient experienced dizziness and nauseous; 7 hours post vaccination at 19:30 experienced, mild headache, sore arm and tired. On 16Apr2021 at 04:30, 16 hours post vaccination, the patient experienced fever, sore arm, tiredness and sweats; 24 hours post vaccination at 12:30, experienced itchy eyes,  hives on eyelids, mild headache, muscle soreness and joint pain. The patient also reported that 48-96 hours after the vaccination, she had hives on eyelids, itchy eyes and joint pain. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. On 16Apr2021 at 04:30, the patient underwent body temperature test and the result was 100.6 (unspecified units). Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the event dizziness, nauseous, mild headache, sore arm, tired, fever, sweats, hives on eyelids, itchy eyes, muscle soreness and joint pain was recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Post vax, pt walked out to the car and complained about feeling dizzy. Mother said she then stiffened and shook, lasted just seconds and mother touched her and she responded immediately. She became pale, "heart racing", and moved to another room in the office. Color good, BP 104/78.
first day after vaccine: chills second day: hives third day: hives spread all over body fourth day: hives spread to face and neck
Information has been received from a physician concerning a 15 year old female who was vaccainted with the first dose of HPV vaccine (lot # not provided). Subsequently the pt experienced low grade fever. The physician reported that the pt received Tylenol and felt better. Subsequently, the pt recovered from the low grade fever. Additional information has been requested.
After 15 minutes the patient experienced dizziness, became pale.  Did not faint.  We had her lay down and elevated her legs.  We gave her water and a sugary snack.  Her blood pressure was 102/60.  After the snack she felt better but was still pale.  She was able to stand and walk 30 minutes after receiving the vaccine and was released to the care of her mother.
This case was reported by a other health professional via call center representative and described the occurrence of injection site erythema in a 23-year-old female patient who received BOOSTRIX (batch number 3457Y, expiry date 20th May 2019). Concurrent medical conditions included drug allergy (CIPRO and Sulfa). On 12th January 2017, the patient received BOOSTRIX (intramuscular) .5 ml. On 13th January 2017, 1 days after receiving BOOSTRIX, the patient experienced injection site erythema, injection site warmth and injection site lump. On an unknown date, the outcome of the injection site erythema, injection site warmth and injection site lump were unknown. It was unknown if the reporter considered the injection site erythema, injection site warmth and injection site lump to be related to BOOSTRIX. Additional details were provided as follows: The patient received a dose of BOOSTRIX in her right deltoid and experienced redness, lump and skin which was hot to touch at the injection site.
pt recvd vax 25OCT93 & devel a red swollen knot in arm & a swollen lymph node; pt was seen by MD 7wks thereafter who recommended that pt be seen by pediatrician;
This spontaneous report as received from a pharmacist who heard from another pharmacist regarding an elderly male patient of unknown age. On an unknown date in June 2013, the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiry date, route and dose were not reported). Concomitant medications were unknown. Approximately on an unknown date in 2013, the patient got chicken pox after receiving ZOSTAVAX. Diagnostic tests performed were unknown. The outcome of chicken pox was unknown. The reporter considered the event chicken pox to be related to ZOSTAVAX. Additional information is not expected.
Arm swollen and red and hurting, feels tired, diagnosed with cellulitis at ER.
partial collapsed lung; This is a spontaneous report received from contactable reporter(s) (Nurse and Consumer or other non HCP), Program ID: (177088).  An 86-year-old female patient received BNT162b2 (BNT162B2), in Aug2021 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "WILD-TYPE TRANSTHYRETIN-RELAT ATTR AMYLOIDOSIS" (unspecified if ongoing), notes: WILD-TYPE TRANSTHYRETIN-RELAT ATTR AMYLOIDOSIS; "ALLERGY TO WASP VENOM TREATMENT KIT" (unspecified if ongoing), notes: ALLERGY TO WASP VENOM TREATMENT KIT; "congestive heart failure", start date: Mar2021, stop date: Mar2021, notes: ended up in the hospital; "atrial fibrillation" (unspecified if ongoing), notes: treated on 12Jul2021. Concomitant medication(s) included: ELIQUIS; FUROSEMIDE; ZOLPIDEM TARTRATE; HYDROXYZINE HCL; LATANOPROST; OMEPRAZOLE; METOPROLOL TARTRATE. Vaccination history included: Moderna covid-19 vaccine (MODERNA COVID (12Y UP)VAC(EUA)), for COVID-19 Immunization; Bnt162b2 (DOSE NUMBER UNKNOWN, SINGLE), for covid-19 immunization. The following information was reported: PNEUMOTHORAX (hospitalization, medically significant), outcome "unknown", described as "partial collapsed lung". The patient was hospitalized for pneumothorax (hospitalization duration: 5 day(s)).  Clinical course: Mar2021 patient got sick from the COVID vaccine and ended up in the hospital for congestive heart failure. 12Jul2021 was treated for atrial fibrillation. Aug2021 she got the COVID booster and went to the hospital for 5 days and had a partial collapsed lung. No additional information available.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal association between the event and suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product 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.
This spontaneous report was received from a consumer refers to a 60 year old female patient. The patient had all around seasonal allergies and animal allergies. The patient was allergic to Sulfa. On 21-MAR-2014, the patient was vaccinated with ZOSTAVAX in the upper left arm (dose and frequency were not reported). Concomitant therapies included ALLEGRA and ZYRTEC (also reported as the patient doesn't take these medications on regular basis). On 21-MAR-2014, 1 day after onset of therapy, the patient experienced to feel dizzy, swelling at the injection site and redness at the injection site. It was reported that the injection site was as large and red as an apple the following day. It was now down to the size of a plum. The patient stated that she was not sure whether her dizziness was from the injection or from the allergies because she suffers from seasonal and animal allergies. The outcome of the events was unknown. The reporter did not provide the causality between the event and the suspect drug. Additional information has been requested.
Last night of vaccination day, chills, nausea, body aches continued body aches next morning other symptoms bother no local reaction.