chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial case received from a consumer who is the patient on 02 July 2013. It represents one of a cluster of four patients reported by the same reporter who each experienced an adverse reaction following administration of IMOVAX and hrig (manufacturer unknown). The events for the other patients are captured in case number 2013-07503. On an unspecified date in 1990 the female patient, age not reported, was administered IMOVAX (batch number not reported) and Hrig, manufacturer unknown, dose, route and site not reported. Concomitant medications and preexisting medical conditions were reported as unknown. It is unknown of the patient received other vaccinations within 4 weeks of vaccination. On an unspecified date in 1990 the patient experienced "Universal reactions to most substances" which has been worsening since 1998 and it is described as being "at it's height now". The patient required an ER/doctor visit on an unspecified date for an unspecified duration. The reporter refused to give her physician's name or any other information. The patient outcome is not recovered. Documents held by sender: None.
Arm sore; This is a spontaneous report from a contactable healthcare professional, the patient. A 35-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL926) via an intramuscular route of administration in the arm left on 04Feb2021 at 16:00 (at the age of 35-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported.  On 04Feb2021, after first dose of vaccination the patient had got arm sore for 4 or 5 days for her 1st dose. It was reported that it was helpful but different than other vaccination(details unspecified). It was unknown whether any therapeutic measures were 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 arm sore was resolved on an unknown date in Feb2021.  The patient also received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6203) via an intramuscular route of administration in the arm left on 25Feb2021 at 15:00 (at the age of 35-years-old) as a single dose for COVID-19 immunisation.  No follow-up attempts are needed. No further information is expected.
Information has been received from a physician concerning a female who was vaccinated in the past 3 months with a dose of Gardasil. Subsequently the patient experienced fainted. Medical attention was sought. The patient's outcome was unknown. Follow up information indicated there were 6 patients who after vaccination with a dose of Gardasil fainted and none of them needed resuscitation. Additional information has been requested.
Patient received COVID vaccine (1st dose 11/2/21 lot # FH8028, 2nd dose as above)  In late December noted to have abnormal thyroid functions and new hyperlipidemia. in March 2022 she presented w/menorrhagia and anemia/thrombocytopenia as well as new nephrotic range proteinuria and AKI.  Renal biopsy consistent with membranous nephropathy, treated with steroids and rituximab
Constant nausea for 3 weeks; Not being able to eat; feeling tired; patient also reports she lost 20lbs due to not being able to eat; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Constant nausea for 3 weeks), FEEDING DISORDER (Not being able to eat), FATIGUE (feeling tired) and WEIGHT DECREASED (patient also reports she lost 20lbs due to not being able to eat) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 015M20A) for an unknown indication.     The patient's past medical history included No adverse event.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to dosage form. On 26-Feb-2021, the patient experienced NAUSEA (Constant nausea for 3 weeks), FEEDING DISORDER (Not being able to eat), FATIGUE (feeling tired) and WEIGHT DECREASED (patient also reports she lost 20lbs due to not being able to eat). At the time of the report, NAUSEA (Constant nausea for 3 weeks), FEEDING DISORDER (Not being able to eat), FATIGUE (feeling tired) and WEIGHT DECREASED (patient also reports she lost 20lbs due to not being able to eat) outcome was unknown. Not Provided          No concomitant medications were provided No treatment medications were provided
Rash became apparent Tuesday - round red patch size of half dollar. Thursday starting to spread down arm. Patient was told to take BENADRYL every 4-6 hours and apply ice.
J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 5/20/2022 CREST SYNDROME R09.02 HYPOXIA 6/3/2022 CREST SYNDROME J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 5/20/2022 CREST SYNDROME R09.02 HYPOXIA 6/3/2022 CREST SYNDROME
Chills, Right shoulder pain & radiation down right arm & back through to shoulder blade.  Increased pain with inspiration or movement of right arm.  Pain > 1 hour then to ED.
intussusception diagnosed & operated 6 days later.  4/24/07 Received medical records from hospital which reveal patient experienced a 1 day hx of bloody stools & emesis with decreased appetite.  Had been transferred from outlying hospital.  Admitted1/21/07-1/25/07.  Surg consult done & taken to OR for exp lap & ileocecectomy w/primary anastomosis.  During surgery there was diffuse purulent fluid found in peritoneum w/necrotic IS.  Patient progressed well & was d/c to home   FINAL DX: Intussusception, surgically reduced.
(1) dry flattened raised violaceous confluent lesions (L) ant thigh 5 x 5 (2) multiple > 15 pustules over thigh (A & P) (L) buttock, intragluteal fold.
skin discoloration six inches below his injection site; his skin turned orange right after Moderna COVID19 Vaccine administration; his skin turned orange right after Moderna COVID19 Vaccine administration; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOLOURATION (skin discoloration six inches below his injection site.), SKIN DISCOLOURATION (his skin turned orange right after Moderna COVID19 Vaccine administration) and ERYTHEMA (his skin turned orange right after Moderna COVID19 Vaccine administration) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024c21a) for COVID-19 immunisation.     No Medical History information was reported.    On 18-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-May-2021, the patient experienced VACCINATION SITE DISCOLOURATION (skin discoloration six inches below his injection site.), SKIN DISCOLOURATION (his skin turned orange right after Moderna COVID19 Vaccine administration) and ERYTHEMA (his skin turned orange right after Moderna COVID19 Vaccine administration). At the time of the report, VACCINATION SITE DISCOLOURATION (skin discoloration six inches below his injection site.), SKIN DISCOLOURATION (his skin turned orange right after Moderna COVID19 Vaccine administration) and ERYTHEMA (his skin turned orange right after Moderna COVID19 Vaccine administration) outcome was unknown.            No treatment information was provided.  No concomitant medication was provided.
VACCINE EXPOSURE DURING PREGNANCY; This spontaneous pregnancy report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient was 1.5 weeks pregnant at the time of vaccination and had a perfectly healthy full-term baby 9 months later. Patient had no reactions or side effects from the vaccine. The patient was gravida 1, para 1. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) 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 patient experienced vaccine exposure during pregnancy. The date of the patient's last menstrual period and expected delivery date were not reported. On an unspecified date, the pregnancy resulted in a live birth. The patient gave birth to a baby of unspecified sex. Birth outcome was normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vaccine exposure during pregnancy. This report was non-serious.
15 year old patient was given ProQuad (MMRV). According to the CDC, she will not need another dose her series is complete, but because she's over age system is counting it as invalid.
Flu vaccine 8:45AM, 12/15/03.  Fever 101 C 12100 Acetaminophen 3:30.  Seizure 4:15.  Lasted 7 min. Took to MD.  Gave Motrin/Acetominophen.  Temperature 102.7 and 102.9 (whole body red, like sunburn).  Temperature 100.2 took home. Gave Motrin/Acetaminophen mix at 9:30.  Temperature 102.6, infant fine at 3:30am.  No fever, redness, fine since then.  Medical Record received on 4/7/2004 states sweating.
Arm soreness never went away after vaccination. At first could not raise left arm straight up to to side without pain. Range of motion gradually decreased--cannot extend arm fully yet. Pain in left shoulder muscle so bad I cannot sleep on left side. Something in upper arm pops like it is sliding into place. Only treatment used is topical Voltaren gel. Over 6 months later I still have bad pain and cannot fully move/use left arm.
Hot large area that was swollen and painful the 1st morning. 2nd day a rash almost covering my upper arm with itching. The rash/ redness is gone today, 3/19/2021, but still have some itching. I have been using Benadryl  cream for the itching.
Right arm swollen, redness, right shoulder painful extends to elbow. Went to ER.
PARTIAL PARALYSIS FACIAL; ADVERSE EFFECT; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin, and batch number were not reported) dose, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  Patient stated that on an unspecified date, vaccine safety concerns wake county sheriff department medical staff untrained adverse effects including partial paralysis facial no fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the partial paralysis facial and adverse effect was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 20211266713-COVID-19 VACCINE AD26.COV2.S-partial paralysis facial. This event(s) is considered unassessable. The event(s) 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(s).
The plunger rod would not fully administer the complete dosage; The plunger rod felt stuck and would not advance anymore"/ "PQC: yes; This spontaneous report has been received from a registered nurse referring to a 12 year old female patient. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not provided.      On an unknown date, during vaccination with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # S022599 with expiration date of 25-FEB-2020, 0.5 milliliter in the left deltoid for prophylaxis, the plunger rod did not fully administered the complete dosage (incorrect dose administered ), reported as the plunger rod felt stuck and did not advanced anymore; it was mentioned that when the needle was removed from the patient, the syringe appeared to have about half of the 0.5 ml dose left in it (syringe issue). combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S022599; expirationdate: 25-FEB-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Patient reported having headache,  fatigue , right neck lymph node swelling and body aches on 05/01/2022.  I recommended patient should take Tylenol 325 mg every 4 hours as needed. Also to see a provider if the symptoms persist or worsen.
Sore and aching body. Could hardly move, headache, fever and chills, very drowsy, stomach pain when I tried to get, nausea. All that lasted all day on 10/02/2021. It's 10/03/2021 now and I feel a little better. Body doesn't hurt as much, can move a bit better, was able to eat a little, still feel hot and sweat, feel weak and puny.
PT SAID SHE HAD FEVER ON 9-29-2014 THEN IT INCREASED TO 100-102 DEGREES. INJECTION SITE HOT /HARD/BLOOD (SHE STATED BLOOD MAY HAVE BEEN THERE PREVIOUSLY) PT STATED CAN'T USE ARM.
just a clear mucus; since yesterday I have been feeling like I have a cold; I have been sneezing; have the (nasal) discharge but nothing else; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SECRETION DISCHARGE (non-serious), outcome "unknown", described as "just a clear mucus"; NASOPHARYNGITIS (non-serious), outcome "unknown", described as "since yesterday I have been feeling like I have a cold"; SNEEZING (non-serious), outcome "unknown", described as "I have been sneezing "; RHINORRHOEA (non-serious), outcome "unknown", described as "have the (nasal) discharge but nothing else".  Additional information: Patient and her son and brother who are going to get the vaccine and she was going to the clinic to get tested and consult her healthcare provider about the vaccination and second dose.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This is a spontaneous report from a contactable female consumer reported for her son. An 18-year-old male patient received TRUMENBA, via an unspecified route of administration in arm on Jul2016 at 0.5 ml, single. The patient medical history was not reported. Concomitant medication included varicella zoster vaccine. The patient experienced swollen arm, his arm hot to the touch, tiredness, headache once or twice. Also had anxiety on an unspecified date with outcome of not recovered. Follow-up (15-OCT-2016): Follow-up attempts are completed. No further information is expected.
Patient developed mild lightheadedness, tight feeling in chest and anxiety while she was driving home after her 15 min observation period. No rash, wheezing, itching. On return to the clinic she appeared mildly anxious. BP 160/75 pulse 65, regular. Lungs clear. No rash or urticaria. 15 mins later her symptoms remained very mild and bp 130/70 and hr 60. At 25 mins of observation she felt symptoms had improved and she was well enough to travel home.
Information was received on 17-NOV-2016 via a field representative who received the information from a nurse. The nurse reported that on an unspecified date, an unspecified 15 year old patient was inadvertently administered a dose of PROQUAD (lot # and expiration date not reported). Medical history, concurrent conditions and concomitant medications were not reported. No adverse effects were reported. No further information provided. Additional information has been requested.
Fainted after the 3rd shot (flu) lasted-6 seconds, hands turned outside and got tight/stiff. C/o leg-calfs pain and not able to walk.
Immediate Rash on his cheek. Has never gone away and has since spread all over his body.
Raised bump on left arm with raised spots; extremely painful; swollen arm Malaise, tiredness, feel like have the flu
Rash lasted six days. Less than 50 pox on body. Very low grade fever. Maximum was 99.8 F. Given Tylenol for 1 day. No complications, nor meds given.
pt stated she started feeling a little itchy the night of vaccines and then woke the next morning with a red, itchy rash mostly contained to her back. When she reported it she said it had basically gone away by 9/7/23
Covid-19 positive; Fever; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Covid-19 positive), PYREXIA (Fever) and FATIGUE (Fatigue) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, the patient experienced COVID-19 (Covid-19 positive), PYREXIA (Fever) and FATIGUE (Fatigue). At the time of the report, COVID-19 (Covid-19 positive), PYREXIA (Fever) and FATIGUE (Fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Apr-2021, SARS-CoV-2 test: positive (Positive) Covid-19 positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant Concomitant medications reported No Treatment information provided
Patient stated he had been given vaccine via drive thru clinic. Patient stated symptoms of swelling and pain started in administration site and then went to elbow and then to wrist within the week of getting the Moderna vaccine
SORENESS IN ARM WITHIN 3 HOURS. HIVES AND HOT TO TOUCH BETWEEN ELBOW AND SHOULDER. HURT TO LIFT ARM ABOVE SHOULDER OR LAY ON ARM. FELT TIRED ALL OVER.
Severe swelling, redness, bump of injection site. Vomitting and Diarea lasting several days. Resulted in developing a lactose intolerance, unable to have milk for over two weeks.
On May 29, 2023, she spiked a fever that was greater than 103-degrees. We took her to the emergency room. While under observation, she had a seizure. She was given IV fluids. The doctor guessed that it was stomach bug and sent us home after tests and observation. She continued to have fever for about one week. It was controlled by OTC fever reducer. She was the 2nd person in a household of four to get sick. Her pediatrician agreed that it was likely a stomach bug.
This patient developed 11 1/2 x 9 1/2 cm area of redness, tenderness and mild induration at the site of vaccination on the right thigh. The patient complains of some pain but no difficulties walking. Seen 06/20/01. Treatment: Zyrtec, Zithromax (for possible cellulitis), ice.
Patient started to exhibit hours after vaccine nausea, vomiting , diarrhea, headache and body aches. She reports she was up all night vomiting. She thought she may have had COVID and took 3 COVID test at home which came back negative. Her nausea and vomiting last through the night but then went away. She is now still feeling headache and body ahces. She presented to clinic today 11/22 with symptoms and wanted to get another COVID test and evaluation.
I've had immunity issues ever since receiving my third dose. I contracted COVID-19 in March of 2022. I then had a really bad upper respiratory infection. I've had a few other things but also contracted Shingles in July of 2022. After recovering from Shingles, I had a tooth abscess and since then I've had yeast infections and urinary tract infections. My immunity just hasn't been the same.
Bilateral swelling under both eyes; This spontaneous case was reported by a nurse and describes the occurrence of EYE SWELLING (Bilateral swelling under both eyes) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Previously administered products included for Drug use for unknown indication: Restylane Silk on 06-Nov-2020. Past adverse reactions to the above products included No adverse event with Restylane Silk.    In November 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, the patient experienced EYE SWELLING (Bilateral swelling under both eyes). At the time of the report, EYE SWELLING (Bilateral swelling under both eyes) 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.   The concomitant medication was not reported by reporter. The Nurse reported that a patient was seen on 06-Nov-2020 and injected with Restylane Silk in the tear troughs bilaterally. The Nurse reported the patient received a covid-19 vaccine some time in Nov-2021 and on 12-Nov-2021 the patient came back to the office after receiving the vaccine presenting with bilateral swelling under both eyes where the Restylane Silk was placed a year earlier. Nurse reported the swelling also had some soft nodules under the eyes. Nurse reported the patient was scheduled to have the Silk dissolved but the patient failed the appointment and never came back to the office. The treatment medication was not reported by reporter.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Fever, worsening neck pain, pain radiating down arm-tingling down arm to painter finger. Severe neck pain left sided-radiating down left scapula. Burning sensation in spine and neck. Duration: 20 days. Treatment: Physical Therapy, gabapentin 100mg twice daily, hydrocodone 1-2 tabs three to four times daily PRN. Patient has known cervical disc disease and had surgery for R arm symptoms several years ago. She has had a R sided occurrence since the surgery with similarly severe symptoms a year or two ago. There are her 1st (L) sided symptoms. She saw her neurosurgeon with MRI results and PT prescribed. No surgery planned. She did take a course of methylprednisolone orally.
Immediately afterwards she passed out and peed her pants. Her mom was sitting next to her and was able to catch her and support her.
Within 5 minutes of administering, employee became nauseated, dizzy, skin cool clammy. Vital signs stable. Seen in ER. 50mg of IM Benadryl given.
Patient called from physician's office on 1/19/15 to report skin reaction to vaccine given Friday. Doctor described as vesicular blisters/red raised rash. Patient came to pharmacy later and said MD says she has shingles.