chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a physician via company representative refers to a patient of unknown age. Patient medical history and current condition was not reported. On an unknown date the patient was vaccinated with GARDASIL second dose, 14 months after patient received first dose of GARDASIL. No adverse effects were reported. Product quality complaint was not reported. The outcome of the event was unknown. Additional information has been requested.
So about two weeks post second vaccination I began to notice growth type thing appear between my legs  and found that it was a lipoma that would get bigger and go away and continue to do so. On November 1st, 2021 I received surgery to remove 2 lipoma, and afterwards  there was still pain. According to my physician there were three more lipoma still present and will be awaiting possible surgery. The lipoma are currently causing pain and swelling all the time now . No prescription was given.
A non serious spontaneous report of influenza type B was received from a consumer concerning a 34 month old female, subsequent to Flumist. The patient's past medical history and concomitant medications were not reported. The patient received Flumist on 14-Sep-2009. ON 16-Sep-2009 the patient developed a running fever of 101.7 degrees Fahrenheit with some sneezing and a runny nose. The patient was tested at the physician's office and was positive for influenza type B. The outcome of the event was not reported.
Golf Ball size lump on outside of left elbow about golf ball sized.  Found following morning after receiving the Pfizer Booster shot.
Arm was extremely sore the first day (couldn?t move my arm for a day and a half). The next day I became very nauseous. I took acetaminophen when I woke up the next morning and vomited within 15 minutes. I tried to sleep and rest as much as possible. At lunch time I ate and took acetaminophen and again vomited with 15 minutes. I didn?t eat until the evening and did not take any medication. The following morning (2 days after the vaccine), I felt better but my arm was still a little sore. I was also very fatigued during this time.
NO adverse event. He is 15 year old male received Twinrix. Twinrix is for 18 and older.
Medical assistant calling to report a temperature excursion that occurred 8/14/2020 which involved the following products: GARDASIL9, PEDVAXHIB, RECOMBIVAX, ROTATEQ. Per caller, "it would be possible that at least 100 patients have received vaccines; This spontaneous report was received from a medical assistant, concerning a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies or concomitant medications were not reported.  On 16-SEP-2020, the patient was vaccinated with an improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) as prophylaxis (lot # T011167 with expiration date 27-MAY-2022) (strength, frequency, route of administration and anatomical location were not reported).  The improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) experienced a temperature excursion of 35.4 Fahrenheit degrees (°F) for the time frame of 20 minutes without previous temperature excursions. It was confirmed that a digital data logger was involved.  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2009USA006106:
Pt stated that after she received the covid vax her nose was hurting and sinuses were burning.  She was not able to sleep since she had a headache and her neck was hurting.  Pt took a Tylenol pm and slept some.  She was nauseated w/ dry heaves.  Her temp was 100.7 . She took another Tylenol pm and slept the entire night.  She feels better today but has developed a rash on the top of her left arm.  She still has a dry cough that she has had since her first vax.  Pt will contact her PCP and schedule a virtual appt.
Information has been received from a health professional, who is a business manager at a pediatric facility, concerning a female (age unknown) who on an unspecified date was vaccinated with Gardasil. Subsequently on an unknown date the patient experienced syncope. The outcome was not reported. This is one of several reports from the same source. Additional information is not expected.
Sedation, Fever & NauseaVomiting Narrative:  Other Relevant History:
Redness & swelling continuing. Slight nausea, skin pain, fever, chills, sweat lasting less than 24 hours
pt seen on 24DEC96 w/a mild case of varicella;recv vax on 28AUG96;
Moderna Covid-19 vaccine that has been out for 16 hours was given to two patients; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (Moderna Covid-19 vaccine that has been out for 16 hours was given to two patients) 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 10-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jul-2021, the patient experienced PRODUCT STORAGE ERROR (Moderna Covid-19 vaccine that has been out for 16 hours was given to two patients). At the time of the report, PRODUCT STORAGE ERROR (Moderna Covid-19 vaccine that has been out for 16 hours was given to two patients) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter.  Treatment information was not provided.
Patient had swelling, increased tenderness, increased warmth in left arm, that started at injection site and extended to under the arm and almost to elbow. Started within 24 hours after PNEUMOVAX injection.
Admitted on 9/26 with c/o generalized weakness. Covid + 2 weeks prior and also on admission. Noted hypernatremia without respiratory distress. Treated with hypertonic saline and followed by nephrology. Progressive respiratory distress and admitted to ICU on 10/3. Treated with remdesevir, dexamethasone and baricitinib. Noted bilateral pulmonary embolism treated with enoxaparin. Required intubation on ventilator. Developed unexplained  profound episodes of hypotension requiring vasoactive medications.  Suffered a PEA arrest during hypotensive episode. 2 rounds of CPR before ROSC achieved. on 10/18 noted atrial fib with rapid ventricular rate. Started on amiodarone and IV magnesium. Vasopressor infusions increased with no help and became pulseless. CPR unsuccessful.
Patient stated that 24 hours after she recieved her Fluzone Hd and Prevnar 13 vaccine she started feeling sick to her stomach with cramps, diarrhea, patient said she also had chills over the weekend and aches. She said the chills and aches have went away but still has the stomach upset.
Woke up 10/31 with severe pain in left arm, upon movement. 11/1/02 Reddened, warm to touch with continued pain and swollen. To PMD 11/1/02; Placed on antibiotic and Clarinex.
On Sunday the 1st I noticed my adenoids were really swollen and so I went to my doctor and we did do a Covid test. He said he thought it was viral and he me a Z-pak and I was waiting for my test results. Some how I never got the results but on the 8th was made aware that I was positive with covid-19. During that week I was so tired that I slept for two days. I did not have a cough or anything like that but I did have a lot of mucus build up. I had some chills but night sweats were terrible.
Pain in arm immediately. Went to bed same night as injection, woke up with painful heart palpitations and a rapid, bounding heart rate.  Became very sick with fever and nausea for the following week. Debilitated with dizziness, chronic fatigue, tachycardia, weakness, and exercise intolerance ever since.
chest pain after 1 week. Throat pain after 2 weeks and still remaining after three months. Neck stiffness. Difficulty swallowing. Episodes of nocturnal panic attacks and difficulty sleeping. Chostocondrtitis.
Chest tightness, shortness of breath, extreme fatigue, dizziness, light head, headache, nausea, and confusion
Extreme pain to vaccination site.  Circular margin at injection site approximately 1 1/2 inches across, blanched  and hair loss in a portion of the margin.  Also complained of extreme joint pain and fatigue.  Pain at injection site progressively worse with each dose.
Patient was scheduled for an appointment for a Johnson &Johnson  covid-19 vaccine through a drive thru Thursday April 8, 2021 @12:45pm. We arrived early and he received the vaccine at 12:15pm, waited 30 minutes for reaction and he was feeling fine. Later that same evening, the patient was driving to work on the freeway when he felt a dry throat so he coughed hard, at that cough he felt a massive pain in his head, like his "head was going to explode." He immediately had tunnel vision closing in on him, so he pulled over and later woke up in our parked car with flashing emergency lights on, parked on the shoulder of the freeway. Disoriented and confused why he was there, he looked at his watch and saw he lost 15 minutes when he had passed out. MY HUSBAND COULD HAVE BEEN SERIOUSLY INJURED OR KILLED IF HE HAD NOT PULLED HIMSELF OVER WHEN PASSING OUT. Today we reported this to our doctors office and to you!
? 7/13/21 1015AM 2nd COVID vaccine from Moderna received. ? 7/15/21 0200AM (times are approximate) o  I started having chest pains in the middle of the night. Sitting or kneeling seemed to relieve some of the pain. It went away after 1500 mg Acetaminophen lasting approx. 3 hrs. ? 7/16/21 (times are approximate) o 0100-0500 Chest pain came back, same style of pressure. No breathing issues. 1500 mg Acetaminophen o 0900 Checked into ER. 7/17/21 Discharged from hospital 330PM
Rec'd imm 10/16/03. Mom reported that 2 days later child covered in rash with red area upper left thigh. Was seen in office 10/20/03 with urticaria chest, legs and arms.
sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient in her 30's received bnt162b2 (BNT162B2), administered in arm (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "diagnosed allergies" (unspecified if ongoing); "compromised immune status" (unspecified if ongoing); "respiratory illness" (unspecified if ongoing); "genetic / chromosomal abnormalities" (unspecified if ongoing); "endocrine abnormalities" (unspecified if ongoing); "diabetes" (unspecified if ongoing); "obesity" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "sick".  Additional Information: Patient got the second dose and patient's mom said patient only became ill with the first dose, not the second dose.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
lightheaded, drank water and laid down for several minutes - symptoms resolved and patient left without further issues
This case was reported by a consumer and described the occurrence of fever in 18month old patient who was inadvertently vaccinated with Pediarix.  The reporter is the mother of the patient.  A physician or other health care professional has not verified this report.  The patient had no known drug allergies.  The patient had a history of a low grade fever following receipt of prior immunizations.  On 14 September the subject inadvertently received a dose of Pediarix rather than the intended administration of Prevnar.  On 14 September 2005 the patient was also vaccinated with Haemophiliius influenzae type b conjugate vaccine.  On 14 September, less than one day after vaccination with Pediarix patient experienced a fever of 102 degrees Fahrenheit.  On 15 September 2005 the subject experienced diarrhea.  Patient was treated with Tylenol and Motrin.  The consumer reported that she had, "difficulty getting the fever down."  On 17 September 2005, the fever and diarrhea resolved.
Fever for 11 straight days reaching 104.3 and averaging 103.7, Severe chills for same duration, migraines, sensitivity to light and day 14 developed Bells Palsy induced by the vaccine. I have not been sick at all for 18 months and was deathly ill within 24 hours after the shot!Blood draw on 09/23/2021 and bells Palsy symptom's started same day, returned to doctor on 09/24/2021 with confirmation of bells palsy.
I woke up around 12:30 in the morning and felt achy. I fainted twice after getting out of bed. I experienced severe aches and body chills. I felt fine the day after better.
HEADACHE, FATIGUE, COUGH, TEMP, BODY ACHES, CONGESTION
Syncope episode shortly after given, fell and sustained concussion. 12/2/08-records received for DOS 10/13/08-DC DX-Closed head injury/concussion. Admitted following a closed head injury from a syncopal episode. Loss of consciousness after vaccination. C/O pain and emesis. Coninued with emesis in ED as well as headache. Overnight observation.
Dizzy, confusion, sensitivity to light, difficulty swallowing, aphasia, worse headaches.
Pregnant patient received the 1st dose of Moderna vaccine; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant patient received the 1st dose of Moderna vaccine) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication.    On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The patient's last menstrual period was on 03-Dec-2020 and the estimated date of delivery was 09-Sep-2021. On 20-Apr-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant patient received the 1st dose of Moderna vaccine). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  nineteenth week of the pregnancy. The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Unknown. At the time of the report, EXPOSURE DURING PREGNANCY (Pregnant patient received the 1st dose of Moderna vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication include Prenatal vitamins.
2:13 AM -> child shaking - "out of it", stopped, vomited went to ER -> temp 102.3, DX otitis & febrile seizure TX -> Amoxil X 10 days.
Patient describes onset of new chest pain, fatigue, and headaches shortly after first Pfizer dose.  Worsened after second dose.  Unable to verify doses or lot numbers, but she recalled the second dose was on 1/8.  She saw her PCP, then her rheumatologist and was sent to the ER for sustained heart rates in the 160s.  Put on 1 month event monitor with no specific issues found except HRs from 60-176 when not exercising.
lost 22lbs; teeth hurting; can't eat; sores in mouth; cold chills; Headache/it's mainly in the back of her head; Diarrhea; Throwing up/threw up 4 times; low grade temp of 100; This is Spontaneous report from a contactable consumer reporting for self. A 61-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140), via an unspecified route of administration in Right arm on 14Jan2021 10:00 at single dose for covid-19 immunisation. Patient received 1st dose of bnt162b2 on 24Dec2020, Lot number: EL0140; She only had a little aches with the first dose. States that she has had Covid before. There were no concomitant medications. She got the 2nd covid vaccine and felt like she got Covid all over again, diarrhea, throwing up, cold chills, and headaches started on 15Jan2021 at around 2:00AM, low grade temp of 100 on 15Jan2021, then she got sores in her mouth and now her teeth hurt. States that maybe it's from the fever. States that she can't eat because it hurts. She lost 22lbs because she couldn't eat. She has been gargling with half warm water and half peroxide. States that she threw up 4 times, but she doesn't even remember how many times she had diarrhea. After she was done throwing up she finally sat down and took her temperature, so it was probably around 4:00-5:00 AM. States that she still has a headache; it's mainly in the back of her head. Outcome of event diarrhea, throwing up, low grade temp of 100, chills was recovered, of headache was recovering, of can't eat and lost 22lbs was unknown, of others was not recovered.
Pruritus, erythema, & edema at site of injection. Additionally, pt reports lightheadedness.
Raised bumps that itch on ankle, elbow, wrist, leg, arm and foot started on 21 Feb 2021 and is still present. Showering and benadryl 25 mgs did not resolve the issue.
This spontaneous report as received from a nurse practitioner via a company representative refers to herself an unknown age female patient. Pertinent medical history, drug reactions or allergies were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX, subcutaneous injection, reported as "standard dose" (lot # was not reported). Concomitant medication was not reported. On an unknown date, the patient developed an injection site rash that was larger than usually that became red, swollen and warm. The reaction lasted for over 1 week. The outcome of the events was reported as recovered. Causality was not reported. Additional information has been requested.
Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Numbness (specify: facial area, extremities)-Medium
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 16-JUN-2014 the patient was vaccinated with improperly stored M-M-R II (subcutaneous, 0.5 ml). Pertinent medical history and concomitant medications were not reported. The reported stated M-M-R II was exposed to a temperature of 8.4 C for less than 10 minutes. No adverse effects Reported. The outcome of the event was unknown. No further information was provided. Additional information has been requested.
Reaction to covid-19 vaccine; Recurred diarrhea; Recurred fever; Recurred fatigue; Teeth chattering/recurred chills; Body aching/muscle pain; Nausea; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION COMPLICATION (Reaction to covid-19 vaccine), DIARRHEA (Recurred diarrhea), PYREXIA (Recurred fever), FATIGUE (Recurred fatigue) and CHILLS (Teeth chattering/recurred chills) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    The patient's past medical history included COVID-19 from 02-Feb-2021 to February 2021, Back pain from January 2021 to February 2021 and Stomach cramps from January 2021 to February 2021. Concurrent medical conditions included Crohn's. Concomitant products included COLESTYRAMINE (CHOLESTYRAMIN) for an unknown indication.   On 23-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 mg. On 24-Apr-2021, the patient experienced VACCINATION COMPLICATION (Reaction to covid-19 vaccine), DIARRHEA (Recurred diarrhea), PYREXIA (Recurred fever), FATIGUE (Recurred fatigue), CHILLS (Teeth chattering/recurred chills), MYALGIA (Body aching/muscle pain) and NAUSEA (Nausea). On 26-Apr-2021, VACCINATION COMPLICATION (Reaction to covid-19 vaccine), DIARRHEA (Recurred diarrhea), PYREXIA (Recurred fever), FATIGUE (Recurred fatigue), CHILLS (Teeth chattering/recurred chills), MYALGIA (Body aching/muscle pain) and NAUSEA (Nausea) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Feb-2021, SARS-CoV-2 test: Positive. In February 2021, SARS-CoV-2 test: Negative. On 30-Mar-2021, Chest X-ray: (Inconclusive) Waiting on results.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was mentioned.  The reporter's causality for the event(s) of back pain, stomach cramps and COVID-19 with was no reasonable possibility.
Pt recvd vax @ 930AM & by noon devel severe migraine h/a; so severe that pt saw MD & got Demerol; Pt was fine by the following day;
Infant patient received an IM dose of Prevnar 13 and  Pentacel on 02/09/2022.  Several hours later he developed a fever of 103.5.  A fever of >102 persisted for 4 days until 02/13/2022.  Notably, he had no viral symptoms of any kind (ie. no cough, runny nose, or congestion) during the entire period of the fever.  He fed well and had ample urinary output.   On the day that the fever resolved he developed a blanching erythematous rash on his torso, limbs and face.  His mother states that his skin is extremely sensitive to foods and she had given him Motrin suspension containing orange dye prior to the onset of the rash.
RECEIVED LESS THAN 0.5 ML OF THE JANSSEN COVID-19 VACCINE AS A BOOSTER DOSE (0.3 ML); OFF LABEL USE; This spontaneous report received from a health care professional concerned a 49 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was previously received covid-19 vaccine ad26. cov2. s for prophylactic vaccination from unspecified manufacturer (form of admin, route of admin, and batch number were not reported), 1 in total, dose was not reported for prophylactic vaccination (Dose number in series 1).  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 213D21A, expiry: 11-APR-2022) dose less than 0.5 ml (approximately around 0.3ml), administered on 01-DEC-2021 to left arm for prophylactic vaccination (Dose number in series 2). No concomitant medications were reported.  On 01-DEC-2021, following vaccination with covid-19 vaccine ad26.cov2.s, the reporter mentioned that patient received less than 0.5 Milliliter (mL) of the vaccine as a booster dose approximately around 0.3 mL of dose (vaccine under dose and off label use) (both events dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the received less than 0.5 ml of the janssen covid-19 vaccine as a booster dose (0.3 ml) and off label use was not reported. This report was non-serious. This case, from the same reporter is linked to 20211210684, 20211210197, 20211209976, 20211210160, 20211210058, 20211209843, 20211209775, 20211210588, 20211210112, 20211210610, 20211210670, 20211210409, 20211210555, 20211210408, 20211209880, 20211210133, 20211209816, 20211209782, 20211212088, 20211212082, 20211209679, 20211209740, 20211210067, 20211210824 and 20211209912.