chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Had a high stage fever at 103.5 and dropped after an hour; This is a spontaneous report from a contactable other healthcare professional, the patient. A 20-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 8448) via an intramuscular route of administration in the left arm on 20Aug2021 at 17:00 (at the age of 19-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient had no known allergies. Concomitant medications included unspecified anti-depressants medication and levonorgestrel (MIRENA) intrauterine device; both for unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 21Aug2021 at 17:30, the patient had a high stage fever at 103.5 and dropped after an hour. On the same day, the patient underwent body temperature test and the result was found to be 103.5 (unspecified units). The event high stage fever at 103.5 did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event high stage fever at 103.5 and dropped after an hour was resolving at the time of this report.  No follow-up attempts are possible. No further information is expected.
covid vaccine breakthrough case  dose 1  Moderna  2/19/21  023M20A dose 2  Moderna  3/16/21  002B21A
Little ball behind the armpit where the second dose was administered/ little ball was painful; Little ball behind the armpit where the second dose was administered/ little ball was painful; This is a spontaneous report from a contactable consumer (patient). A 34-years-old female patient  received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Lot Number was not reported) via an unspecified route of administration on 22May2021 as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient did not received any other products and investigation assessment was not reported. She stated that she had a little ball behind the armpit where the second dose was administered, the little ball was painful. She had her second dose administered on saturday i.e. 22May2021 and by Sunday i.e. 23May2021 it was painful. The outcome of both the events was unknown.  No follow-up attempts are possible. No further information is expected.
VACCINE ADMINISTERED IN RIGHT DELTOID AT 1105 AM.  DIRECTED TO BE MONITORED IN RECOVERY WAITING AREA.  AT 1115 PATIENT DID VERBALIZE SHE FELT SHE WAS GOING TO "PASS OUT"  IMMEDIATELY AFTER, THE PATIENT LOST CONSIOUSNESS AND EMS NOTIFIED.  EMS WORKUP DID SHOW HER FLUCTUATING TACHY AND BRADYCARDIA.  SHE WAS THEN SENT OUT TO HOSPITAL FOR OBSERVATION.  PATIENT DID VERBALIZE AWARENESS OF THE EVENT AND STATED SHE FELT BETTER.  pATIENT WAS COMPLIANT ABOUT RECEIVING FUTHER OBSERVATIONAT ED.  VITALS STABLE PRIOR TO DEPARTURE, ACCUCHECK READING 124, A&OX3 WITH VISUAL NEURO CHECK wnl. pATIENT DID SELF TRANSFER FROM COT TO CART AND rom X4 NOTED.  PATIENT DID NOT HAVE ANY VISABLE REACTION SIGNS/SYMPTOMS AT THE SITE OF INJECTION.  sHE DENIES PAIN THROUGHOUT,  NO FURTHER NEEDS ANTICIPATIED ATPOINT OF TRANSFER FROM FACILITY TO  ed
Low grade fever, below 100 degrees F; joint aches; chills; fatigue; This is a spontaneous report from a contactable consumer. A 63-year-old female patient (non-pregnant) received second dose of BNT162B2 (BNT162B2, solution for injection, Batch/Lot Number: en6206, Expiration date: not reported), via an unspecified route of administration, administered in Arm Left on 13Apr2021 11:30 as a dose 2 single (age at vaccination: 63-year-old) for covid-19 immunisation. Medical history included known allergy: Penecillin. The patient's concomitant medications were not reported. no other vaccine in four weeks and no other medications in two weeks. The patient is not pregnant at time of vaccination. Covid prior vaccination was No and Covid tested post vaccination was No. The patient received historical vaccine as first dose of BNT162B2 (BNT162B2, solution for injection, Batch/Lot Number: en6207, expiration date: not reported), via an unspecified route of administration, administered in Arm Left on 23Mar2021 08:30 AM as a dose 1 single (age at vaccination: 63-year-old)for covid-19 immunisation. The patient previously took macrobid [clarithromycin] and had allergies to it. On 15Apr2021 08:00 the patient experienced low grade fever, below 100 degrees f, joint aches, chills and fatigue. . Basically have it intermittently throughout every day, not preventing sleep at night. Taking Ibuprofen for symptoms of aches and fever. Has been ten days since injection and symptoms are not changing. no worse, no better. The patient underwent lab tests and procedures which included body temperature: low on 15Apr2021 Low grade fever, below 100 degrees F. No treatment was received for events. Events were reported as non- serious. The events was not recovered.
Patient says her throat swelled up and she started coughing about 11 pm. She did not seek medical attention at that time because she could still swallow. She saw her physician on 10/3/09-diagnosed as severe allergic reaction to vaccine-angioedema. She still is coughing up phlegm.
Chills; high fever; Body ache; cough; severe headache; Nausea; This is a spontaneous report from a contactable other hcp. A 59-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: EN5318), dose 2 and via an unspecified route of administration, administered in Arm Left on 17Feb2021 14:15 as SINGLE DOSE for covid-19 immunization. Medical history included, cardiac disorder, angiopathy from an unspecified date. Historical drug included BNT162B2 for COVID-19 immunization. Concomitant medication(s) included dronedarone hydrochloride (MULTAQ); metoprolol tartrate (METOPROLOL TARTRATE); levothyroxine sodium (SYNTHROID) taken for an unspecified indication, an unspecified date. The patient experienced chills, high fever, body ache, cough, severe headache and nausea on 18Feb2021 01:00. The outcome of the events was recovered.  No follow-up attempts are possible. No further information is expected.
BLOOD FROM RECTUM; BLOOD FROM VAGINA; INJECTION SITE SORENESS; This spontaneous report received from a patient concerned a 54 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included menopause for about 3 years.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, 1 total administered on 29-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 30-MAR-2021 after a long morning walk, the patient had bleeding from her vagina and from rectum (anus); it was big dollops of bright red blood in two distinct regions about the size of half dollars. The patient also had the usual soreness at the injection site had lasted for about three to four days, however the bleeding was unusual for her. The patient reported the events to her primary care physician, who responded that the events must be coincidental. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from blood from vagina, and blood from rectum on 31-MAR-2021, and injection site soreness on APR-2021. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 : 20210424821- covid-19 vaccine ad26.cov2.s-Blood from rectum. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Soreness in arm, persisted for 2 days Muscle aches all over body, began 2/16/2021 in the evening, 8 hours post-vaccination - persisted for 3 days Fatigue/tiredness, began 2/16/2021 in the evening 8 hours post-vaccination - persisted for 4 days
5/7/09 9AM MOM CALLED STATED CHILD RECEIVED IMMS. DTAP, HEP A. AND PREVNAR ON 5/4/09 AT 7:00 AM.  SHE NOTED ? NODE ON CHILD'S HEAD AND BACK OF LEFT EAR.  I TO GO TO ER FOR DR CHECK.  MD NOTIFIED
Muscle aches, injection site soreness, fever, chills, feeling cold started after vaccination and continued at least until 5/12/17. Pt made an appointment to see her PCP on 5/16/17. Pt also reported several symptoms that began before vaccination including but not limited to nausea and syncope.
Child received vaccine on 9/1/09.  At 1:30 am 9/2/09 child had "throat closing, audible wheezing and difficulty breathing.  Benadryl given & symptoms resolved.  Denied hives or facial swelling.  Were preparing to take child to ER but did not due to improved symptoms.
Had strong ringing in my ears; Very tired; This is a spontaneous report received from a contactable reporter(s) (other healthcare professional). The reporter is the patient. A 62-year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 06Jan2022 08:15 (Lot number: 33025BD) at the age of 62 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Being treated from a bad fall which had several surgeries as a result from falls." (Unspecified if ongoing), "Being treated from a bad fall which had several surgeries as a result from falls." (Unspecified if ongoing). Concomitant medication(s) included: GABAPENTIN, CARISOPRODOL, HYDROCODONE/IBUPROFEN, ATORVASTATIN, TRAZODONE, DICLOFENAC SODIUM. Vaccination history included: Bnt162b2 (Dose number: 1, Lot number: EH9899, Route: Intramuscular, Vaccine location: Right arm) administration date: 29Dec2020 for COVID-19 immunisation, Bnt162b2 (Dose number: 2, Lot number: EL1284, Route: Intramuscular, Vaccine location: Right arm) administration date: 19Jan2021 for COVID-19 immunisation. The following information was reported: TINNITUS (non-serious) with onset 06Jan2022 12:30, outcome "recovering", described as "Had strong ringing in my ears", FATIGUE (non-serious) with onset 06Jan2022 12:30, outcome "recovering", described as "Very tired". Therapeutic measures were not taken as a result of tinnitus, fatigue.  Additional information: Prior to vaccination, was the patient did not diagnosed with COVID-19. Since the vaccination, patient has been tested for COVID-19 was unknown. Patient not had known allergies. Patient adverse event started with in four and half hours after the third dose patient became very tired, had strong ringing in my ears. Had to go home from work.  Follow-Up (18Jan2022): Follow-up attempts are completed. No further information is expected.
aprox 1-1/2 hrs later area of injection swelled,painful,hot,red. I repeatedly iced area,took 1 Tylenol. by next morning redness,swelling,spread. area hard,hot,painful. continued to ice.rest.Tylenol. By evening area became very itchy. applied topical cortisone cream. Sunday morning injection site very swollen,hot,ithcy,painful. looked online-decided to continue ice,Tylenol,topical cream and go to walk in clinic  next day if worsens. Monday morning(Labor Day) went to walk in clinic. Just visual exam and was told to see pharmacy where injection was done. Pharmacy closed for holiday. continued to ice. slightly less painful. still red,swollen,hot,itchy.
Information was received from a registered nurse referring to an unknown number of patients of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On unspecified dates starting on or after 21-JUL-2016, the patients were administered doses of improperly stored PROQUAD injection (lot # M004897, expiration date 26-JUL-2017, recombinant human albumin (rHA); lot# reported as L011528 which was invalid, expiration date 03-APR-2017; lot# M003436, expiration date 19-JUL-2017, recombinant human albumin (rHA) (dose and route unknown). The vaccines were exposed to 24.3 Fahrenheit degree (F) for 2 hours 50 minutes. There was no previous temperature excursion. Digital data logger was involved. No adverse event was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Patient complained of having trouble breathing following receiving her vaccine.  When observed her bottom lip was swollen and swelling of her tongue was noted.  An epi pen was administered and 911 was called.  She was monitored and vitals were assessed until an ambulance arrived and was able to transport her to the hospital
We noticed that the interval given between the shots was too short of a time period.  The first dose was given on 01/29/21 and the second on 2/17/21.  no adverse events noticed, but we wanted to communicate error.  Patient resided in nursing home during time of administration and administering pharmacist had no knowledge of when prior shot given
no additional AE; pediatric dose of V AQT A was administered to a 36 year old patient rather than the adult dose; This spontaneous report was received from a medical assistant concerning a 36 years old patient. No medical history, concurrent condition or concomitant therapy was reported.    On 29-APR-2021, pediatric dose of hepatitis a vaccine, inactivated (VAQTA) (at the dose of 0.5 ml; route, lot# and expiry date were not reported) was administered to the patient rather than the adult dose (product administered to patient of inappropriate age) as prophylaxis. No additional adverse event (AE) was reported.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's concurrent condition, medical history and drug reactions/allergies were not reported. Concomitant therapies included sterile diluent. On 06-FEB-2018 the patient was vaccinated with one dose of improperly stored VARIVAX (lot # N023960, expiry date: 01-SEP-2019), (dose, frequency and route were not reported) for prophylaxis. No adverse effects reported. Product quality complaint was not involved. VARIVAX was exposed to temperature of 6 degree Fahrenheit (F) to 14 F for 36 minutes. There was no previous temperature excursion reported. The digital data logger was involved.
Sensations in left forearm & wrist:  intense pain; soreness; tightness (in ligaments/tendons?); heat; swelling; AWFUL pain!  I don't know how to treat these symptoms or whether they will subside -- if so, hopefully sooner rather than later!
Fever and chills on the day of the vaccination Pain in the leg (right thigh), 2 days after the vaccination, persistent pain for 2 days now
Developed Alopecia Areata. I developed golf ball size patches in my hair out of nowhere. I have never had hair loss or thinning before
This spontaneous report was received from a 27 year old female patient referring to herself via Pfizer. The patient's medical history included knee surgery in 2005 and also that her period continued for 6 weeks, her current conditions included knee pain. The patient's concomitant therapies included naproxen. On 16-MAY-2017, the patient was inadvertently vaccinated at the physician's office with PROQUAD, 0.5 ml, intramuscularly in the right arm for prophylaxis, the patient was supposed to receive DEPO-PROVERA, which was her usual therapy started since the beginning of 2013, for contraception (strength, dose, frequency and route were not provided) and her 4 years old daughter, was supposed to receive the vaccine. This is one of the two reports received from the same reporter. Sender's Comments: US-009507513-1709USA013588.
Acute onset of R facial nerve palsy on 10/16 with progression to severe bells palsy.  Seen in ER on 10/17 Treated with steroids.  10/20 treated with antiviral and referral to ophthalmology due to progression of weakness.
Patient developed RLE DVT and saddle PE causing significant dyspnea.  Diagnosed with RV strain requiring thrombectomy and anticoagulation.  Was told the thrombi were due to COVID-19 vaccination given vaccine was given 4 days prior to onset of symptoms.  However, patient did have a 4hour flight during which he was sedentary.  Dyspnea started after this flight.
6 month old had severe vomiting, with 7 episodes in the first hour of onset. The last 3 of these episodes contained yellow bile. Infant was lethargic, not reaching for toys or attempting to roll over (as would have been normal), but was sleepily alert and responsive. Infant was given a teaspoon of breastmilk (administered via syringe) an hour after vomiting stopped initially, and promptly resumed vomiting again. After about 3 hours from onset, infant began to keep small amounts of liquids down (pedialyte and breastmilk), and was able to breastfeed normally again by the evening. No diarrhea occurred, although there was some significantly stinky flatulence.
I know a lot of people got symptoms after the second dose.; This spontaneous case was reported by a health care professional and describes the occurrence of ADVERSE EVENT (I know a lot of people got symptoms after the second dose.) in a patient of an unknown age and gender 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT (I know a lot of people got symptoms after the second dose.). At the time of the report, ADVERSE EVENT (I know a lot of people got symptoms after the second dose.) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications and treatment information were reported.
Mild fever (99.5+) for few hours; This is a spontaneous report from a contactable consumer, the patient. A 32-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6203), via an unspecified route of administration in the left arm on 24Mar2021 at 11:15 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 24Mar2021 at 21:00, the patient experienced mild fever (99.5+) for a few hours in the evening after the second dose. The adverse event did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the event mild fever (99.5+) for a few hours. The clinical outcome of the event mild fever (99.5+) for a few hours was recovered on an unknown date in Mar2021.   No follow-up attempts are needed. No further information is expected.
NO ADVERSE EFFECTS AT PRESENT IMMUNIZATION GIVEN OUT OF RECOMENDED GUIDELINES (ROTAVIRUS)
Red circle and some inflammation, increase the skin temperature like warm where got the shot; Red circle and some inflammation, increase the skin temperature like warm where got the shot; Red circle and some inflammation, increase the skin temperature like warm where got the shot; This is a spontaneous report from a non-contactable consumer (patient). A female patient of approximately 47-year-old 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 Aug2021 as dose 1, single for COVID-19 immunization, in pharmacy. The patient medical history and concomitant medications were not reported. It was reported that, it had been 10 days since the patient received the vaccine and said she still had red circle and some inflammation when she received the shot (vaccine) warm like increase the skin temperature (red circle and some inflammation, increase the skin temperature like warm where got the shot) on an unspecified date in 2021. The patient did not remember in which arm she got vaccination, the patient said she had the red circle where she got the shot. The patient asked was that normal. The patient was suggested to reach out where she received the shot. She reached out to the Doctor to find out if it was normal or what they should do to find out Medical (assistance). The patient received no treatment for the events. Limited information was available over the call and appropriate response could not be provided. The outcome of the events was reported as not resolved.  Follow-up attempts have been completed. Batch/lot number not available for BNT162B2. No further information is expected.
SEVERE MUSCLE DEEP TISSUE PAIN THAT STRETCHED TO POSTERIOR TRAPEZOID, DELTOID AND A LITTLE TO THE QUAD AND GENERALLY TO THE WHOLE BODY; EXTREME DISCOMFORT BUT THERE WAS NO CONTRACTION OR CRAMPING AND NO SWELLING; This spontaneous report received from a patient concerned a 63 year old female. The patient's weight was 120 pounds, and height was 68 inches. The patient's past medical history included: suspected covid-19, bronchitis, and pneumonia, and concurrent conditions included: non alcohol user, smoker, and penicillin allergy, and other pre-existing medical conditions included: The patient had no history of drug abuse or illicit drug usage. The patient was previously treated with azithromycin; and experienced drug allergy when treated with erythromycin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1820096, and expiry: 21-OCT-2021) dose was not reported, administered on 15-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On AUG-2021, the patient experienced extreme discomfort but there was no contraction or cramping and no swelling. On 15-AUG-2021, the patient experienced severe muscle deep tissue pain that stretched to posterior trapezoid, deltoid and a little to the quad and generally to the whole body. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from extreme discomfort but there was no contraction or cramping and no swelling, and severe muscle deep tissue pain that stretched to posterior trapezoid, deltoid and a little to the quad and generally to the whole body on 18-AUG-2021. This report was non-serious.
This spontaneous report was received from a Pediatrician through her husband, who also was a Pediatrician, via a company representative and refers to a female patient of unknown age. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On an unknown date, the patient was vaccinated with the first dose of GARDASIL 9 (strength, route of administration, anatomical location, lot # and expiration date were not reported) for prevention of Human Papilloma Virus (HPV). It was reported that, after the patient was vaccinated with this first dose, she fainted and then fully recovered within the same office visit. As a precaution at the scheduled second dose with GARDASIL 9 (strength, route of administration, anatomical location, lot # and expiration date were not reported) for prevention of HPV, the physician administered this dose, on an unknown date, while the patient was lying down, but the patient immediately stated that "she felt sick" (not specified the description of sickness). This malaise lasted the entire day before she recovered. The patient was not hospitalized and it was unknown if she received any treatment for the adverse experiences. The causality assessment between the syncope and malaise, and vaccination with GARDASIL 9 was not provided.