chrisvoncsefalvay/vaers-outcomes huggingface dataset:
4/16/07 acute vomiting, stomach pains - screaming seen in ER and fever and Diarrhea ? Paralytic Ileus  GI consult - Bilious Emesis and concern for intussusception and flims/KUB normal s/p enema with good results.  07/02/2007 MR received for hospital stay 4/19-21/2007.  Infant developed intermittant, severe abdominal pain (evidenced by back arching and screaming) and emesis 5 days prior to admission.  Seen in ER x 2 for above and progression to bilious vomiting and acting "lifeless".  2nd ER visit with DX of constipation and enema given with improvement initially.  Symptoms reoccured and child was admitted. Barium enema succesfully reduced intussusception.  Feeding, stooling, and voiding well post procedure. DX: c/w Intussusception.
lump that looks like the top third of a small egg, on the clavicle; closer to the joint than to neck. It felt like bone. No pain. It seemed to "spread out." Wider, but not as defined; Aches after movement, such as going for a walk or vacuuming; right lymph node in my neck was tender; scratchy throat; slept on-and-off for most of the day; following the second vaccine I ran alow grade fever the following day.; This is a spontaneous report from a contactable consumer, the patient. A 79-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via an unspecified route of administration in the right arm on 17Mar2021(at the age of 79-years-old) as a single dose for COVID-19 immunisation. Medical history included chronic kidney disease stage 3 from an unspecified date. The patient had no known allergies. The patient did not receive any medication within two weeks of vaccination. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202) via an unspecified route of administration in the right arm on 24Feb2021 at 16:15 (at the age of 79-years-old) as a single dose for COVID-19 immunisation. Prior to the 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 four weeks prior to the vaccination.  On 18Mar2021 the patient experienced low grade fever. On 20Mar2021 at 06:00 the patient experienced mass, ache, lymph node tenderness, itchy throat, sleep disturbance. It was reported that third morning following second vaccine, the patient woke up with a lump, that looked like the top third of a small egg, on her clavicle; closer to the joint than to her neck. It felt like bone. No pain. It seemed to "spread out." Wider, but not as defined. The past few days it was back with a vengeance. Aches after movement, such as going for a walk or vacuuming. Also, following the second vaccine she ran a low-grade fever the following day, her right lymph node in her neck was tender and she had a scratchy throat. As it progressed, it felt as if her throat was closing, and then it disappeared just about the time she was getting concerned. She had slept on-and-off for most of the day. The next day she was fine, but still had the bump. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of events mass, ache, lymph node tenderness, itchy throat, sleep disturbance, low grade fever was not recovered at the time of reporting.  No follow-up attempts are needed. No further information is expected.
Pt woke up 9/1 - clingy, didn't eat, listless, spacey, low grade temp.  Knew sister's name but couldn't remember her brother's name morning & afternoon. Seen at her PCP's office at 3:10 & could remember brother's name, feeling more normal.  9/3/09 - completely back to normal.
Information has been received from a registered nurse concerning a haemodialysis male patient who in approximately July 2005 was vaccinated with the first dose of PNEUMOVAX 23. In March 2010 the patient received the second dose of PNEUMOVAX 23 but may have possibly be given 1 ml dose instead of 0.5 ml intramuscularly. The nurse also reported that the patient was helping his son move and was lifting heavy objects when he died at the end of June 2010 (Date unknown). The registered nurse thought that the cause of death on the certificate stated cardiac problems, but was unsure since she did not have the medical records at the time of the report. Additional information has been requested.
Pt. called describing a severe headache of entire head area with some throbbing at about 7PM. Contacted pt. before closing pharmacy at 9PM and she had taken some Tylenol and had little relief. Suggested I call in the morning and see how she was doing. Said she had awakened at 2 AM and pain was still there. Also complained of stiff neck and some hearing loss. At 8:30 am when I called was doing better and by 4PM called to give an update and said she thought she was going to survive.
No additional AEs; Pharmacist states the product leaked out where the syringe meets the needle during administration.; Pharmacist states the product leaked out where the syringe meets the needle during administration.; This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant therapies, and previous drug reactions or allergies was not provided.  On 05-MAR-2021, the patient was vaccinated with one dose of 0.5 milliliters (ml) of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX 23) injection as prophylaxis (vaccination scheme frequency, route of administration, and anatomical location were not reported; lot number reported as T020639, has been verified to be a valid lot number pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX 23) prefilled syringe, expiration date reported and validated as 13-MAR-2022). It was reported that during the administration. According to the pharmacist, the product leaked out where the syringe meets the needle during the vaccine administration (device leakage and poor quality device used). No adverse events were reported. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T020639; expirationdate: 13-MAR-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
I had a normal menstrual period on April 19 (27 days after the previous one) but then I started bleeding again on May 1, only 11 days later. The bleeding has been light on some days, then it switched to medium, then back to light, then medium again... and  it continued for 17 days now. I searched for possible explanations for this, and found that other women are noticing this after their covid vaccine, so I decided to report it. I will see my ObGyn in three days for this issue. This type of long, 2+ week vaginal bleeding has never happened to me before.
Pt. states that after receiving the 1st dose of Phizer 08/26/2021, started experiencing symptoms of hives, numbness throughout the body, heaviness in the chest, and shortness of breath. Lasting 2 1/2 weeks, Primary recommendations to not receive the 2nd dose of Phizer due to symptoms.
Information has been received from a physician concerning a 15-year-old with no pertinent medical history and no allergies, who on December 06,2005, was vaccinated subcutaneously with a 0.5 ml does of varicella virus vaccine live (Oka/Merck) (lot #646536/0550R). There was no concomitant medication. About 7-10 days later, on approximately December 12,2005, the patient developed general pox eruptions with more than 50 lesions with itching. Unspecified medical attention was sought. It was reported that he was treated with diphenhydramine hydrochloride (Benadryl). The patient's status was unspecified by the reporter. No product quality complaint was involved. Additional information has been requested.
Arm was sore the immediate 2 days following vaccination and then again 8 days after vaccination, arm was sore, hot and warm to the touch for 2 days.
vertigo, redness, erythema  Narrative: symptoms resolved after 30 minutes in the  observation area, patient discharged to home with wife driving
No adverse reaction; Dose 1 and Dose 2 taken on 29-Dec-2020 and 10-Jan-2021, 12 days apart; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 and Dose 2 taken on 29-Dec-2020 and 10-Jan-2021, 12 days apart) and NO ADVERSE EVENT (No adverse reaction) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004N20A and 026L20A) for COVID-19 prophylaxis.     Previously administered products included for Drug use for unknown indication: Codeine. Past adverse reactions to the above products included Allergy with Codeine.   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Jan-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 and Dose 2 taken on 29-Dec-2020 and 10-Jan-2021, 12 days apart). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse reaction). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 13-May-2023 to 17-May-2023 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 and Dose 2 taken on 29-Dec-2020 and 10-Jan-2021, 12 days apart) and NO ADVERSE EVENT (No adverse reaction) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-May-2023, SARS-CoV-2 test: Positive.         No concomitant medications were reported. On 10-Nov-2021, the patient received 3rd dose of Moderna Covid-19 vaccine with batch/lot number: 053E21A on left arm.  On 01-Jul-2022, the patient received 4th dose of Moderna Covid-19 vaccine with batch/lot number: 017B22A on left arm. On 11-Oct-2022, the patient received 5th dose of Moderna Covid-19 vaccine with batch/lot number: 049D22A on left arm. It was reported that patuient had a symptoms of bad taste left in mouth that made everything taste bad.  On 13-May-2023, the patient was diagnosed with covid-19 at urgent care. Patient was tested on 21-May-2023. On 23-May-23, covid rebound symptoms were started. The device date was reported as 25-May-2023.
INTOLERANT TO ALCOHOLIC BEVERAGES, NO IMMUNITY AFTER 2ND DOSE, NAUSEATED" AFTER 2ND DOSE OF ENGERIX-B PT BECAME NAUSEATED FOR SEVERAL DAYS AND INTOLERANT OF ALC. BEVS(EVEN 1 BEER) PT'S SERUM CHECKED,REVEALED NO IMMUNITY AFTER 2ND DOSE.
Red circle (2-3 inches) at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Red circle (2-3 inches) at injection site) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (Red circle (2-3 inches) at injection site). At the time of the report, VACCINATION SITE ERYTHEMA (Red circle (2-3 inches) at injection site) outcome was unknown. Not Provided      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 assessment.  Concomitant product use was not provided by the reporter.  No treatment medication was reported.
rash on my face; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash on my face) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jan-2021, the patient experienced RASH (rash on my face). At the time of the report, RASH (rash on my face) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The relevant concomitant medications were also not provided.  No treatment information was provided.
bleeding at injection site; It is itching today; does not feel anything; flat rash, not elevated/rash advancing, going down forearm; flat pink advancing/ pink area was replaced by a mustard yellow; hives 3-4 inches down injection site 3-4 inches down the arm; not feeling good; site of injection was kind of itchy; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (not feeling good), VACCINATION SITE DISCOLOURATION (flat pink advancing/ pink area was replaced by a mustard yellow), URTICARIA (hives 3-4 inches down injection site 3-4 inches down the arm), VACCINATION SITE HAEMORRHAGE (bleeding at injection site) and RASH PRURITIC (It is itching today) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 065F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 27-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Nov-2021, the patient experienced FEELING ABNORMAL (not feeling good) and VACCINATION SITE PRURITUS (site of injection was kind of itchy). On 29-Nov-2021, the patient experienced VACCINATION SITE DISCOLOURATION (flat pink advancing/ pink area was replaced by a mustard yellow) and URTICARIA (hives 3-4 inches down injection site 3-4 inches down the arm). On 02-Dec-2021, the patient experienced VACCINATION SITE HAEMORRHAGE (bleeding at injection site), RASH PRURITIC (It is itching today), SENSORY LOSS (does not feel anything) and RASH (flat rash, not elevated/rash advancing, going down forearm). At the time of the report, FEELING ABNORMAL (not feeling good), VACCINATION SITE DISCOLOURATION (flat pink advancing/ pink area was replaced by a mustard yellow), URTICARIA (hives 3-4 inches down injection site 3-4 inches down the arm), VACCINATION SITE HAEMORRHAGE (bleeding at injection site), RASH PRURITIC (It is itching today), SENSORY LOSS (does not feel anything) and VACCINATION SITE PRURITUS (site of injection was kind of itchy) outcome was unknown and RASH (flat rash, not elevated/rash advancing, going down forearm) had not resolved.            Patient is on concomitant medication, but does not provide the names.  Treatment information was not provided.  On 02-DEC-2021, the pink area was replaced by a mustard yellow.
Rash/hives that turned into redness and swelling all over the body, purple lips/fingers that resulted in an ER visit where they confirmed he was having a vaccine reaction
This case was reported by a physician via call center representative and described the occurrence of injection site swelling in a 11-year-old female patient who received MENVEO. On an unknown date the patient received MENVEO (subcutaneous). On an unknown date, 5 days after receiving MENVEO, the patient experienced injection site swelling, injection site itching and intramuscular formulation administered by other route. On an unknown date, the outcome of the injection site swelling, injection site itching and intramuscular formulation administered by other route were unknown. It was unknown if the reporter considered the injection site swelling, injection site itching and intramuscular formulation administered by other route to be related to MENVEO. Additional details were provided as follows: The age at vaccination was not reported. The patient received MENVEO subcutaneously. This led to incorrect route of administration. The health care professional did not provide lot number and expiration date of the MENVEO; in addition, the reporter did not provide full patient demographics. The health care professional did not provide any additional information about the injection site reaction when speaking to the medical information system.
Date of Admission:  2/19/2022   Chief Complaint:  Abdominal pain    Source of Information:  Spouse / chart review   History of Present Illness:  This is a 75y.o. female with past medical history of hypothyroidism, stage IIIb T2N2 metastatic pancreatic adenocarcinoma status post Whipple procedure with Dr. 5/24/2021 status post gemcitabine chemo (stopped last September due to unable to tolerate), essential hypertension, type 2 diabetes, DVTs of the lower extremities (8/25) was placed on Eliquis (January 2022), stasis dermatitis.  Patient presenting to the emergency department via EMS from home given worsening abdominal comfort and wish for a second opinion for her pancreatic adenocarcinoma.    Patient's husband states that his wife has been experiencing pain that is not new.  Pancreatic cancer, but yesterday was much worse.   EMS was called to try to see if there is anything else that could be done for pancreatic cancer given excruciating pain she is experiencing.  Patient's husband states that patient underwent surgery back in May 2021 for the pancreatic cancer.  After that patient was started on chemotherapy which had to be stopped in September due to patient not being able to tolerate it and patient presenting with blood clots in her legs at the end of August.  At this time patient was enrolled in hospice due to poor prognosis and due to husband not being able to fully care for her at home (unclear timeline of what type of facility/when patient returned back to current residence).  Patient was then treated for her lower extremity DVTs with Eliquis until around January 2022.  Patient's husband states that over this time his wife started experiencing more problems with her legs, ulcerations and fluid leakage had she frequently need to see the doctor for.  Patient states that recently her oncologist stated that she had 2 months to live he wanted to get a second opinion to see if there is anything else that could be done.    ED course  Vitals: BP 104/70, heart rate 111, temperature 97.9, SPO2 98% on room air       Labs: Sodium 123, chloride 93, bicarb 10, anion gap 20, creatinine 1.71, albumin 2.0 and then alk phos 1889, AST 107, ALT 64, lipase 4, troponin 0.04, pH 7.18 Imaging: CT of the abdomen pelvis showing moderate volume of abdominal and pelvic ascites, postsurgical changes of the small bowel and pancreas without evidence of obstruction, bilateral inguinal lymphadenopathy, small left right pleural effusions, hypoattenuation involving the hepatic segment IV, postsurgical changes with drain localized in the head and body of the pancreas Meds: Dilaudid 1 mg x 2, Zofran, 500 mL normal saline bolus x4 Consultants: GI/interventional radiology/oncology
Redness on his palms and bottom of his feet; Felt like pins and needles; Rash on forearms and chest; Progressively worse; This spontaneous case was reported by a nurse and describes the occurrence of ERYTHEMA (Redness on his palms and bottom of his feet), PAIN (Felt like pins and needles), CONDITION AGGRAVATED (Progressively worse) and RASH (Rash on forearms and chest) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     Concomitant products included LAMOTRIGINE (LAMICTAL), ZIPRASIDONE and VITAMINS NOS (MULTIVITE [VITAMINS NOS]) for an unknown indication.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced CONDITION AGGRAVATED (Progressively worse). On 16-Mar-2021, the patient experienced ERYTHEMA (Redness on his palms and bottom of his feet), PAIN (Felt like pins and needles) and RASH (Rash on forearms and chest). The patient was treated with METHYLPREDNISOLONE SODIUM SUCCINATE (SOLUMEDROL) at a dose of 1 dosage form. At the time of the report, ERYTHEMA (Redness on his palms and bottom of his feet), PAIN (Felt like pins and needles), CONDITION AGGRAVATED (Progressively worse) and RASH (Rash on forearms and chest) had not resolved.        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.
Mother reports symptoms started following day x 5 days; nausea, fatigue, loss of appetite, back pain.
So sick I wish I'd never had it done; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had a mild case of shingles in April (year unspecified)). Previously administered products included Shingles vaccine with an associated reaction of pain in extremity (1st dose received on an unknown date, refer case US2022AMR116806.).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.     Linked case(s) involving the same patient:  US2022AMR116806   Additional Information: GSK Receipt Date: 06-AUG-2022.  Reporter's Comments: This case was reported by patient via interactive digital media. The patient had mild case of shingles, so they recommended after that, that the patient got the series of two shingles vaccines. The second one made patient so sick, the patient wished he/she would have never had it. Additional Supportive Information: Follow-up would not possible as no contact details were available.; Sender's Comments:  US-GSK-US2022AMR116806:Same reporter.
administered via intravenous (intubated emergently); This non-serious case was reported by a pharmacist via call center representative and described the occurrence of intramuscular formulation administered by other route in a 84-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2022-2023 season) (batch number 2772C) for prophylaxis.   On 02-APR-2023, the patient received Fluarix Quadrivalent 2022-2023 season (intravenous). On 02-APR-2023, an unknown time after receiving Fluarix Quadrivalent 2022-2023 season, the patient experienced intramuscular formulation administered by other route (Verbatim: administered via intravenous (intubated emergently)). The outcome of the intramuscular formulation administered by other route was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt date:3-APR-2023 Fluarix was administered via intravenous to a patient by mistake. The Vaccine Administration Facility was the same as Primary Reporter. No expiration date was reported. The patient ended up being intubated emergently. No further details provided at the time of call. The reporter consent to follow up via email. Patient was administered Fluarix Quadrivalent via intravenous, which led to intramuscular formulation administered by other route.