chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a nurse referring to a male patient of unknown age (one of twins). No concurrent or historical conditions were reported. On an unknown date the patient was vaccinated with ROTATEQ (lot#, expiration date and dose unspecified), orally. No concomitant medication was reported. He sought medical attention at the office of nurse for a routine exam on 29-MAY-2015 and was diagnosed with an ear infection. No lab diagnostics studies were performed. The outcome of the event was reported as not resolved. This is one of several reports received from the same source. Additional information has been requested.
I have a runny nose; I am sneezing; I am having vertigo; my mouth taste 'tangy'; I am winded; I am having pain in areas that I never had pain before; I feel so dizzy like it fells like I am gonna pass out; This is a spontaneous report from a contactable consumer (patient). A 56-years-old patient of an unspecified gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number and expiration date was not reported) via an unspecified route of administration on 12Sep2021 (at the age of 56-years-old) as DOSE 1, SINGLE for COVID-19 immunization. Medical history included diabetes mellitus, hypertension, renal transplant; post kidney transplantation, anxiety, post-traumatic stress disorder: PTSD from an unknown date and unknown if ongoing. Concomitant medications included tacrolimus (PROGRAF), mycophenolate sodium (MYFORTIC), prednisone (PREDNISONE), fish oil (OMEGA 3 FISH OILS), xantofyl (LUTEIN) and magnesium (MAGNESIUM) taken for an unspecified indication. It was reported that, patient had first dose of COVID 19 virus (COVID-19 Vaccine) about 2 hours ago. Almost 11 years ago patient had a life donor kidney transplant (Intent: Medical History). Patient was on 2 different types of immunosuppressant (concomitant product). Patient worked for government and was being pressured to take the vaccine patient had the vaccine and about 2 hours ago on an unspecified date in Sep2021 patient had a runny nose, sneezing, having vertigo, dizzy, mouth taste tangy (Further not clarified), patient was winded and patient was having pain in areas that patient never had pain before. Patient did exercise so feel so dizzy like it fells like patient gonna pass out. Patient's blood pressure and pulse seems to be fine. Patient did not have a temperature and that was only 2 hours after vaccine. patient was not sick already and as far as patient did not have COVID and had not been around any point with COVID. Treatment: Consumer stated, No. Patient took immune suppressant prior to (Incomplete sentence), take immunosuppressant 3 times a day and patient took second dose (Of Immunosuppressant) an hour and a half before the injection but patient did not take any medication to correct any of the feelings (Adverse Event). The patient underwent lab tests and procedures on an unspecified dates which included blood pressure measurement: fine, body temperature: do not have a temperature; do not have a temperature and that was only 2 hours after vaccine, heart rate: fine; pulse seems to be fine and SARS-COV-2 test: did not have COVID and had not been around any point with COVID. The outcome of all events was unknown.  No follow-up attempts are needed; information about lot/batch number can not be obtained.
Eruption of cold sore on lip.  Although cold sores have occurred in the past, this is not a common thing for me (typically go years between having one).  Had been >1 year since last cold sore eruption.
Pt devel fever & severe h/a p/concurrent administration of Cholera & Typhoid vax; The pain was not relieved by aspirin, some relief noted w/Acetaminophen w/codeine; Pt had recvd both vax 30JUL90 with no side effect;
Vaccine started at 4. Roughly 5 minutes after, I raised my hand in the waiting for for the male nurse to come over due to symptoms of dizziness, loss of consciousness, ?blacking out?, and confusion. The male nurse came over and started seeing signs of profuse sweating as water began dripping from all over my body. 5 minutes after that I started heaving and gasping for air unaroused next to the nurse as he took my blood pressure. Blood pressure dropped to 85/76. I started breathing heavy, sweating uncontrollably and couldn?t talk or stand. I remained hardly alert and almost passed out due to weakness.
Fully vaccinated, not boosted. COVID-19 infection breakthrough with inpatient hospital stay.
Redness, density, warm to touch at injection site. Shoulder weakness, and pain radiating down arm and to axilla.
Within 2 minutes: dizziness Within 10 minutes: fast hear rate, purplish skin color, tightness of throat, fatigue  Over the next 3 days: irregular heart rate, fatigue Over the next week: missed period, repeated negative pregnancy tests by self and physician  2months later: period starts late and blood pours out running down legs and  pooling on floor period last 2 days. Face shows signs of weight gain, no actual weight gain occurs.  3 months later: all seems normal
4/11/2021   Pt was observed post Covid-19 immunization for 15 minutes .  During the observation period, she experienced an adverse reaction with the following symptoms:  dizziness, weakness and jittery, loss of vision.   Assessment : Time of assessment ** 415pm*. Alert and oriented and Pallor.   Actions taken:  Vs taken at 510pm BP- 69/45, P-59, O2- 100%, juice, water, cookies and potato chips given, patient is consuming, feet elevated in chair, recheck of VS at 525pm- BP- 89/57. P- 58, O2-100%, she is alert , answering questions appropriately, continues to drink and eat, recheck of VS at 540pm, BP- 104/72, P- 57, final BP at 543pm 101/67.        Medications administered: No medication administered.   Disposition: Reports no further symptoms of adverse reaction after observation for 30 minutes. Discharged home. The Patient was provided with Vaccine Information Sheet and instruction to access the  system.   Patient left with friend.      Immunizations Administered    Name Date Dose VIS Date Route   Pfizer COVID-19 Vaccine 4/11/2021  5:06 PM 0.3 mL 12/11/2020 Intramuscular   Manufacturer: Pfizer, Inc   Lot: EP7533   NDC: 59267-1000-2          Electronically signed by RN at 4/11/2021  5:58 PM  Immunization on 4/11/2021   Detailed Report  Note shared with patient
Information was received from a medical assistant who stated that multiple temperature excursions involving GARDASIL took place from 20-FEB-2014 through 06-MAR-2014. Improperly stored vaccines of GARDASIL were administered to unspecified patients on unspecified dates (dosages and routes of administration were not provided). Lot numbers of the impacted vaccines are as follows: J011272, expiration date 21-APR-2016 (reported as 16-APR-2016); J010396, expiration date 16-FEB-2015; J013277, expiration date 06-AUG-2015: J006850, expiration date 31-MAR-2016 (reported as 10-JUL-2015); J006850, expiration date 31-MAR-2016 (reported as 06-AUG-2015); and J009788, expiration date 17-MAR-2016. No adverse effects reported. Lot number J010396 is an invalid lot number for GARDASIL. Additional information has been requested.
Headache. Began with pains at my temple near my eyes, night of the vaccination. Had a headache that night, overnight. Have had a combination of sporadic pains near my temples, and a headache that feels like a band around my head, particularly around both temples. Mostly okay upon waking, pains start after a couple of hours, then actual headache is present from about 1-2 p.m. until I go to sleep.  This description applies to second vaccine, administered 3/25/21.   For the first vaccine, administered 3/4/21, I had pains by my temples that early evening, then a headache that night until bedtime. I think that headache only lasted one day. I had fatigue for a day following each dose.
Sick; Initial information was received on 01-Nov-2020 regarding an unsolicited valid non-serious social media case from a consumer via Social Media.  This case involves a patient (unknown demography) who was sick (illness), while the patient received INFLUENZA VACCINE.  Medical history, medical treatments, concomitant medications, vaccinations and family history were not provided.  On an unknown date in 2020, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious was sick (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of report, the outcome was unknown for the event.  There will be no information available on the lot number for this case.
Narrative:  Causality of death is unknown. Report is of timing of vaccination 2/5/21 to death 3/3/21
Swollen Lymph nodes under left arm. Left upper arm swollen, intense pain in left arm with limited range of motion in left arm morning after flu shot. One week later Bell's Palsy to right side of face, muscle weakness in legs, extremely fatigue, electric shocks in both arms and legs. Intense pain in left arm from injection site to elbow to wrist continues 6 months later as well as extremely fatigue and weak.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 72-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Apr2023 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 72 years for COVID-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, COVID-19. Additional information: The patient has no known allergies. The patient's COVID-19 treatment was Paxlovid from 15Sep2023 to 20Sep2023.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Received DTaP on 6/30/09. c/o pain at injection site approx 4-5PM. Redness began approx 6-7P 6/30/09. Seen in office on 7/1/09 approx 11AM - swelling of the thigh around injection site - 4cm x 5cm redness around injection site warm to touch. Rx - BENADRYL 1 tsp 2x/ml, cephalexin 250 TID x10D, ice pack 2-3x/day. Return to office 7/2/09.
C/o chest pain radiating from back to front 1 wk post vaccine.  Denies rashes or other symptoms state went to ER & was "ruled out for heart problem".  States occasionally still has pain  Instructed pt to notify primary MD of symptom & make appt.  Pt had not F/U with her MD, said she "thought ER would".
Blistering rash , discoloration of feet and ulcers , severe head headache blurred vision started 6 hours after second shot and had progressed over the past several days
10 minutes after injection, i was sitting in the observation room when i felt a wave of shakiness, wooziness, and lightheaded.  I asked for my BP to be checked and it was 150/100.  My usual BP is 117/74.  My BP continued to be elevated and peaked at 167/107 approx 30 minutes after the injection.  My BP remained 150/104 the rest of the day, and continued to be elevated 5 days after injection.  During that time, i felt a headache, intermittent dizziness, and feeling shakey.  Day 2-3 i experienced the listed symptoms of headache, diarrhea, chills, body aches, joint pain, and fatigue.  These symptoms subsided within 12 hours.  On day 5, by BP slowly started to lower. I saw my primary MD monday 12/28, at which time my BP was 138/90.  Currently, my BP is 128/86, significantly lower than day of injection, but not at baseline yet.
tingling; This spontaneous case was reported by an other health care professional and describes the occurrence of PARAESTHESIA (tingling) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PARAESTHESIA (tingling). At the time of the report, PARAESTHESIA (tingling) outcome was unknown.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant drugs were not reported. Treatment medications were not provided.  It was reported that patient had side effect of tingling after booster.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. There was no information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies provided. On 14-NOV-2016, the patient was vaccinated with incorrectly stored dose of M-M-R II (dose, frequency, route of administration were not reported, lot # M000768, expiration date 05-JAN-2018. No adverse effects were reported. Administered dose of vaccine experienced the temperature excursion of -14.4 degrees Celsius for 54 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information is not expected, all information has already been obtained. ; Sender's Comments:  US-009507513-1611USA011831: US-009507513-1611USA004113: US-009507513-1705USA009742:
Treatment of COVID-19; Treatment of COVID-19; Started to take Paxlovid, recurrence in symptoms 11 days later; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old male patient received BNT162b2 (BNT162B2), on 11Feb2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 69 years for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19"; DISEASE RECURRENCE (medically significant), outcome "unknown", described as "Started to take Paxlovid, recurrence in symptoms 11 days later". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: indication=Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19, disease recurrence. Clinical course: Any other medication in 2 weeks was not reported. Patient started to take Paxlovid, recurrence in symptoms 11 days later. Patient was taking anti viral drug from 23Aug2022 till 27Aug2022 for treatment of Covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Transient rash on 4/17/00, resolved that night. Hoarseness on 4/18/00, usually worse in mornings and slightly better by evening. No fever. Looking pale.
Extremely sore arm for 3 days. Vaginal bleeding (one week before expected cycle), bright red, heavy bleeding for 7 days, then some spoting for 2 days. Normal period has 2-3 days of red, then some brown spotting for 3-4 days.
COULD NOT SLEEP; HEADACHE FOR TWO DAYS; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the subject experienced could not sleep, and headache for two days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache for two days, and the outcome of could not sleep was not reported. This report was non-serious.
Large (entire upper arm) has huge bruise. Pt. went to doctor and they said it was pooling blood from injection site.
That evening, April 2, 2021 (the day of the vaccine)  a nicked my pinky knuckle on my left hand while changing my daughter's crib sheet and it immediately swelled and turned red.  That resolved by Saturday morning, April 3, 2021.  However, now the left side of my left hand is still bruised as of Tuesday, April 6, but there is no pain associated with the bruise.  It simply has not cleared up yet.
Patient developed throat tightness but no other symptoms. No rash, flushing, swelling.  Sxs self resolved with observation. Vitals remained stable with BP 110/70s Sat 98%. Patient discharged home in good condition.
By evening child threw up. Child broke out with hives. Mother consulted pharmacist and was told due to varicella shot. As of today child is OK. Pt parents not contacted by HD.
Patient presented to ED w/ chest pain and shortness of breath x2 days. Onset 8 hours after getting Moderna vaccine. He was found to have a moderate left pleural effusion.  He was only hypoxic with ambulation to 89%, not hypoxic at rest.
Ringing in the ears; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Ringing in the ears) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025520A and 139Y20K) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced TINNITUS (Ringing in the ears). At the time of the report, TINNITUS (Ringing in the ears) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medications were reported.
Information has been received from a physician concerning a 69 year old male who on 28-MAR-2007 was vaccinated with a dose of Zostavax (Merck), subcutaneously in the left arm (LOT#656412/1476F). Subsequently the patient experienced breakthrough of shingles at the injection site. The patient never had shingles before receiving the vaccination. Subsequently, the patient recovered from breakthrough of shingles. Additional information has been requested.
Pimples in the rash; It was warm to the touch; Arm rash eventually grew bigger,rash was after the first shot; Left arm itched; Left arm was red; Left arm was feverish; a welt at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of ACNE (Pimples in the rash), VACCINATION SITE WARMTH (It was warm to the touch), RASH (Arm rash eventually grew bigger,rash was after the first shot), VACCINATION SITE URTICARIA (Left arm itched) and VACCINATION SITE SWELLING (a welt at the injection site) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension, Latex allergy (latex allergy) and Drug allergy (sulfa drug allergy). Concomitant products included HYDROCHLOROTHIAZIDE, LISINOPRIL (LISINOPRIL/HCTZ) from 2000 to an unknown date for Blood pressure high, ASPIRIN [ACETYLSALICYLIC ACID], MULTIVITAMINS & MINERALS PLUS LUTEIN and VITAMIN D3 for an unknown indication.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced VACCINATION SITE SWELLING (a welt at the injection site). On 14-Mar-2021, the patient experienced VACCINATION SITE URTICARIA (Left arm itched), VACCINATION SITE ERYTHEMA (Left arm was red) and PYREXIA (Left arm was feverish). On an unknown date, the patient experienced ACNE (Pimples in the rash), VACCINATION SITE WARMTH (It was warm to the touch) and RASH (Arm rash eventually grew bigger,rash was after the first shot). On 16-Mar-2021, ACNE (Pimples in the rash), VACCINATION SITE WARMTH (It was warm to the touch), RASH (Arm rash eventually grew bigger,rash was after the first shot), VACCINATION SITE URTICARIA (Left arm itched), VACCINATION SITE SWELLING (a welt at the injection site), VACCINATION SITE ERYTHEMA (Left arm was red) and PYREXIA (Left arm was feverish) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 15-May-2021: Reporter detail, Rechallenge details ,Patient demographics and Event outcome updated. On 16-Jul-2021: Follow up received on 16-JUL-2021 and contains no new significant information
Pt declined to bring child in - attempted to bring child in several times - per MOP - rash appeared the night he got the shot.  She reported it as "chickenpox" on legs buttocks & genitalia area.
Several hours after receiving my 1st covid vaccine, after midnight the next morning, I was awakened by excruciating upper, right abdominal pain. I broke out into the sweats. I was shaking so badly from the pain, I could not stand up. The pain was immense (worse than childbirth). I didn't know what was happening. The pain felt like a hot knife had been plunged into my right side, near the pancreas, gall bladder and liver. I then proceeded to vomit profusely. After approximately 45 minutes, the pain began to subside. I was completely warn out +I felt like someone had sucked all if the blood out of my body. I fell back to sleep and everything seemed normal. Since my 2nd dose, I have had these same bouts (in the same location(). They come randomly, now. The pain radiates into my lower abdomen and up into my sternum. It is completely debilitating. It stops me in my tracks. I cannot afford to have this happen to me. I have started a new career and it has taken a toll on my energy levels.
A spontaneous report was received from a nurse concerning a patient, unknown age, who received COVID-19 Vaccine and some vaccine leaked out of syringe on patient's arm. The patient's medical history was not provided. No relevant concomitant medications were reported.  On 04 Feb 2021, the patient received their first of two planned doses (Batch number not provided) intramuscularly in the arm for prophylaxis of COVID-19 infection. On 04 Feb 2021, the nurse reported that while administering the COVID vaccine some of the vaccine leaked out of the syringe on the patient's arm. Treatment information was not provided. Action taken with second dose response to the event was not provided. The event was considered resolved on 04 Feb 2021; Reporter's Comments: This report refers to a case of Incorrect dose administered  with no associated AEs.
Developed a large raised red rash about 1 week after vaccine dose 1, with fatigue and flu like symptoms. Rash lasted 2 weeks and fatigue lasted longer.
Redness, swelling, warmth measuring 6.5 cm x 10.5 cm in the area of the left deltoid.
Patient developed localized swelling, followed by extended tenderness, swelling, warmth, redness which extended to left shoulder (cellulitis) (area of DTP).
Pt reported redness and swelling of entire right upper arm beginning approximately 1-2 hours post administration.  Pt reports experiencing chills approximately 24 hours post injection.  Reported temperature of 98.8F 24 hours post injection.  Denies all symptoms of anaphylaxis.