chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was considered medically important. Information regarding PREVNAR 13 was received from a physician regarding a 3-year-old female patient who experienced unwilling to use one of her legs, severe cramping of leg, couldn't get her to walk, wouldn't bend her leg, had excruciating pain in leg and overdose vaccine - extra dose administered. At 3 years of age, the patient received the first dose on 25-May-2010. The patient experienced being administered an overdose of vaccine - extra dose administered severe cramping of leg and unwilling to use one of her legs on 25-May-2010, within an hour of the PREVNAR 13 injection. These events resolved within 15 minutes. On 26-May-2010, while the child was at daycare, they could not get her to walk and she wouldn't bend her leg for an hour or so. On 04-Jun-2010, the patient continued to not bend her leg and was in excruciating pain in leg. Excruciating pain and not bending her leg were not resolved. Severe cramping, unwilling to use one leg, and unwillingness to walk were resolved. Outcome of extra dose administered, overdose is unknown. No additional information was available at the time of this report.
Information has been received from a physician concerning a 4 year old male w/ NKDA and no past medical history who in 09/98 was vaccinated with one dose of varicella virus vaccine live (site unknown). There was no concomitant medication. On approximately 07/13/01, the patient developed a rash all over his body which was consistent with the look of an initial varicella infection. The child had 30-40 lesions all over his body. The rash was described as "vesicles although some of them are papules". The patient sought unspecified medical attention. There was no additional information provided.
Per telephone conversation with pt on 3/5/01: Pt stated he works for fire dept. As a work requirement, he received Hep-A and Hep-B vaccinations on 1/25/01 in the AM at hospital. He stated that he received the IM injections in the deltoid muscles, 1 in left arm and the other in the right arm. He is uncertain which arm received which vaccine. Pt states that both arms were sore within 4 hours, post vax, but his right arm was especially painful to touch and movement. The pain in arms subsided after a few days. On 1/31/01, pt stated he experienced chest pain with "squeezing sensation" at 22:00. His left arm became numb after chest pain subsided and remained numb the next AM. Pt reported to work but at 09:00 went to the ER. He had a cardiac work-up but nothing was found. He was released from the hospital on 2/2/01. Pt was advised to quit smoking and was discharged with Zyban, Lipitor and clozapine. On 2/21/01, pt stated he was symptom free and that he had quit smoking on 2/14/01. In the AM, he used a solvent to remove adhesive. He broke out in hives all over his body. The hives became worse and at 22:00, he was seen at the hospital. He states he was given Benadryl. He was still covered in hives the next morning. On 2/23/01, woke up at 02:00 with a fever, aches and sore throat. On 2/24/01, pt stated he had pain under the right rib on palpation. Pt stated he continued to have hives on his face and upper arm. He had testicular pain. Pt stated that he had no appetite, difficulty sleeping, right knee pain during the next few days. Pt is being seen by surgeon for heartburn and bleeding in the esophagus. Pt states that it was suggested that he has a bacterial infection and that the Hep-A and Hep-B vaccination preceded the chest pain by 1 week, about time for an incubation period. Pt wonders why when he has been healthy all his life he should suddenly have all these problems and suggests that the vaccinations may have been causative.
Flu like symptoms.  Severe muscle aches, swollen glands in neck and groin, headache, diarrhea, exhausted
A 4-inch long, 2 to 2.5-inch wide, oblong, red rash at injection site appearing approximately nine days after date of injection.
No adverse reaction; Dose 1 and Dose 2 administered on 04-Jan-2021 and 01-Mar-2021; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 and Dose 2 administered on 04-Jan-2021 and 01-Mar-2021) and NO ADVERSE EVENT (No adverse reaction) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Concurrent medical conditions included Osteopenia, Arthritis, Rosacea and Diarrhea predominant irritable bowel syndrome.   On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 and Dose 2 administered on 04-Jan-2021 and 01-Mar-2021). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse reaction). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 and Dose 2 administered on 04-Jan-2021 and 01-Mar-2021) and NO ADVERSE EVENT (No adverse reaction) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse reaction) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 and Dose 2 administered on 04-Jan-2021 and 01-Mar-2021).    Patient's ethnicity was reported.  No concomitant medication was reported.  Reportedly, patient further received Pfizer / BioNTech vaccine as a 3rd dose on 06-Oct-2021 and Pfizer / BioNTech vaccine as a 4th dose on 08-Mar-2022 and Bivalent dose as a dose 5 on 21-SEP-2022.  No treatment information was provided.
Presented to clinic with c/o red, swollen and found area at VZV injection site LA. Recommended to f/u with MD. ER MD dx with reaction to VZV.
The patient was getting an injection but she pulled away and received about half the medication, no adverse event; Initial information was received on 05-Jun-2020 regarding an unsolicited valid non-serious case from a nurse  This case involves an 11 year old female patient who was getting a DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL]  injection but she pulled away and received about half the medication (Underdose)  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MENINGOCOCCAL VACCINE A/C/Y/W CONJ (DIP TOX) (MENACTRA) and HPV VACCINE VLP RL1 4V (YEAST) (GARDASIL)  On an unknown date, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot U6638AA, expiry 12-Apr-2022) via intramuscular route in the left arm for prophylactic vaccination  It was a case of an actual medication error due to vaccine underdose  It was reported that a female nonpregnant child was getting the injection and pulled away so she only received about half the medication.  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Headache, severe pain & swelling in arm (that was injected) treated with NSAIDS, chills.
redness of the area, now turning to pinkish; Soreness of the arm; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Soreness of the arm) and INJECTION SITE ERYTHEMA (redness of the area, now turning to pinkish) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025I20A) for Covid-19 vaccination.     Concurrent medical conditions included Low platelets.    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jan-2021, the patient experienced INJECTION SITE PAIN (Soreness of the arm). On 05-Jan-2021, the patient experienced INJECTION SITE ERYTHEMA (redness of the area, now turning to pinkish). At the time of the report, INJECTION SITE PAIN (Soreness of the arm) and INJECTION SITE ERYTHEMA (redness of the area, now turning to pinkish) outcome was unknown.        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.   Concomitant product use was not provided by the reporter. No treatment information was provided.  Based on the current available information and temporal association between the use of the product and the onset date of the  reported events, a causal relationship cannot be excluded.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the  reported events, a causal relationship cannot be excluded.
Received flu vaccine yesterday, 10/10/2005, patient presented to office today with urticaria on chest, back, upper and lower extremities. Child has no c/o sore throat, cough No fever. Physical exam wnl. TX: Benadryl qid for 2 days prn
Severe shoulder pain due to flu vaccine administered too high on arm. Inability to move arm above head without extreme pain.  Received Covid vaccine at same time, but it was administered much lower on arm and only mild localized pain at that injection site.
Child broke out in papular rash on face the evening of her immunizations.  Developed a temp of 101 fluctuating over several days.  The rash appears more obvious when child is hot or irritated. No scabs.
Client had one Varicella vaccine at 1 yr and at 12 dx'd with chickenpox.
This spontaneous report was received from a male patient of unknown age who was referring to himself. There was no information regarding the patient's medical history, concomitant medications, drug reactions or allergies provided. On an unknown date, the patient was vaccinated with ZOSTAVAX for prophylaxis (dose, route, lot number and expiration date were not reported). The patient stated, that he received ZOSTAVAX a few months after receiving a corticosteroid shot (the time between the two shots was unspecified). On an unknown date, the patient experienced serious aches and pains on all parts of his body. The outcome of the event was unknown. The relatedness between the event and ZOSTAVAX was not provided.
Headache, Myalgia & NauseaVomiting Narrative:  Saw OHS provide on 2/12/2021. Zero days of missed work.  Other Relevant History:
She stopped smiling and looking into our eyes she no loner was playing holding rattlers binkies or fingers she cried all the time the first 2 days after the shots you could see she had went from smiling happy baby to a quite distant baby..
magnesium and potassium got down to 1; magnesium and potassium got down to 1; This is a spontaneous report from a contactable consumer (patient's sibling) via a Pfizer sponsored program. A 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 03Feb2021 (Lot number: EL9265; Expiry: 31May2021) at the age of 67 years old as 1st dose, single for COVID-19 immunisation. Medical history included ongoing type 2 diabetes mellitus. The patient's concomitant medications were not reported. The reporter stated that after the first dose, the patient had to go to the emergency room, and it was found that her magnesium and potassium were low (also reported as magnesium and potassium got down to 1) on 04Feb2021. The reporter didn't know what was going on with the patient and she was taken to the hospital. The emergency doctor stated that had the patient gone much longer without medical attention right away, she would've died. They were then advised by the emergency doctor to follow up with the family doctor. The patient went to the family doctor and was put on magnesium. The outcome of the events was unknown.
Red localized raised rash on the left arm approximately 3 inches x 2 inches that last 6 days. Body aches, fever, chills, nausea and vertigo
This spontaneous report as received from a physician refers to an unspecified number of patients of unknown age and gender with no pertinent medical history/drug allergies or drug reactions reported. On an unknown date, the patients were vaccinated with a dose of GARDASIL (route, anatomical location, lot# and expiration date were not reported). There was not concomitant therapy reported. On an unknown date the patients experienced urticaria "hives". The outcome of urticaria and was unknown. This is a linked report from  the same reporter 1504USA020634. Additional information has been requested.
Moderate headache; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 63-year-old female patient received BNT162B2 (PFIZER-BIOTECH COVID-19 VACCINE, solution for injection), dose 1, administered on left arm on 12Mar2021 at 14:15 (Lot number: not available at the time of report completion) as 1st dose, single dose (at the age of 63 years old) for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient has known allergies on prednisone. On 12Mar2021 at 15:15 the patient experienced moderate headache for 30 minutes onset after vaccination which lasted about 3 to 3.5 hours. It was resolved after hydrating with two bottles of water and food at dinner time. The patient received no treatment for the event. The outcome of the event was recovered on 12Mar2021 19:15.  No follow-up attempts are possible; information on lot/batch number cannot be obtained.
IPOL given on that day was an extra dose/vaccine history for the child that showed he had received vaccination, with no adverse event; Initial information was received on 12-Sep-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 5 years old male patient who experienced IPOL given on that day was an extra dose/vaccine history for the child that showed he had received vaccination, with no adverse event vaccination while receiving vaccine IPV (VERO) [IPOL].  The patient's past vaccination(s) included IPOL POLIO VACCINE. The patient's past medical history, medical treatment(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID (KINRIX) for Immunisation; and MEASLES VACCINE LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE (JERYL LYNN), RUBELLA VACCINE LIVE (WISTAR RA 27/3) (MMRVAXPRO) for Immunisation.  On 06-Aug-2021, the patient received one dose of 0.5 ml of suspect IPV (VERO) (lot 49281-86-78) (formulation, strength, and expiry date: unknown) via intramuscular route in left thigh for prophylaxis vaccination.  On 06-AUG-2021 the patient developed a non-serious ipol given on that day was an extra dose/vaccine history for the child that showed he had received vaccination with no adverse event (extra dose administered) (Latency same day) following the administration of IPV (VERO).  Action taken with POLIOMYELITIS VACCINE (INACTIVATED) (IPOL) was not applicable.  At time of reporting, the outcome was Unknown for the event ipol given on that day was an extra dose/vaccine history for the child that showed he had received vaccination with no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Chronic combined systolic and diastolic congestive heart failure. ED visit and hospital admission. This visit was within 6 weeks of receiving the COVID vaccine.
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 78-year-old male patient received BNT162b2 (BNT162B2), on 26Jan2021 as dose 1, single (Lot number: el9265), on 16Feb2021 as dose 2, single (Lot number: en6200), on 03Oct2021 as dose 3 (booster), single (Lot number: 30b5b4) and on 01Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 78 years for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient had no other medication in 2 weeks. Treatment start date was reported as 03Jun2022 and treatment stop date was 07Jun2022. It was reported that 5 days after completing treatment, all cold symptoms reappeared. Adverse event start date was reported as 11Jun2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Swelling about 1 inch below the injection site, then a rash similar to that caused by a spider bite
WIFE REPORTS APPROXIMATELY ONE HOUR AFTER RECEIVING VACCINE, PATIENT'S LEFT ARM BECAME SWOLLEN AND PAINFUL AT INJECTION SITE. NO TREATMENT WAS GIVEN. WIFE CALLED OFFICE THE NEXT DAY AND REPORTED SYMPTOMS. SYMPTOMS BY THEN HAD DECREASED AND PATIENT STATED HIS ARM WAS "BETTER". WIFE WAS ADVISED TO APPLY ICE, ELEVATE PATIENT'S ARM AND GIVE OTC PAIN MED (ACETAMINOPHEN OR IBUPROFEN) IF NEEDED AND TO CALL OFFICE IF SYMPTOMS DID NOT RESOLVE OR CONDITION WORSENED.
Initial information received on 07-Mar-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (office staff). This case involves a female patient of unknown age who presented an unspecified viral infection after received vaccine INFLUENZA VACCINE.(unknown manufacturer). The patient's past medical history, medical treatment(s), vaccination(s), family history and concomitant therapy were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site. On an unknown date, the patient presented an unspecified viral infection (viral infection), following the administration of INFLUENZA VACCINE. No lab test was reported. Final diagnosis was viral infection.. It was not reported if the patient received a corrective treatment. The event outcome was not reported.. List of documents held by sender: none.
5:10pm noted to be scratching with single hive on back, diphenhydramine given 5:20pm noted to be wheezing, Albuterol nebulizer given 5:45pm wheezing continues, Prednisone given 6:00pm wheezing improved but still present, transported to ER from clinic
Swelling and redness at injection site. Nurse Practitioner determined it was infected, ordered Keflex 500 mg 3 times for 10 days beginning 11/19/13.
1/8/21 4am woke up with hard chills and freeing no fever. Aching ALL over. felt like the flu. tylenol 1000, every 4-5 hours.  began having sharp pains just above my left temple about 3 hours ago. Intermittent.
1 day after receiving the ADACEL vaccine, noticed raised, red, elevated area distal medial to injection site, warm.
COVID-19 Vaccine-Induced Liver Injury; This is a literature report for the following literature source(s):  A 58-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "alcohol use" (unspecified if ongoing), notes: Less than 1 drink/week; "HLD" (unspecified if ongoing); "Hepatic steatosis" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE), for COVID-19 immunisation. The following information was reported: LIVER INJURY (medically significant), 12 days after the suspect product(s) administration, outcome "unknown", described as "COVID-19 Vaccine-Induced Liver Injury". The patient underwent the following laboratory tests and procedures: Alanine aminotransferase: Return to baseline; normal; Alanine aminotransferase: 101 IU/l; Antibody test: Unknown results; Negative; Antimitochondrial antibody: Positive; Antinuclear antibody: Negative; Aspartate aminotransferase: Return to baseline; normal; Aspartate aminotransferase: 51 IU/l; Biopsy liver: Mild porto-sinusoidal vascular disease., notes: Mild ferritin and hemosiderin deposition. No evidence of autoimmune hepatitis or steatohepatitis; Blood alkaline phosphatase: 77 IU/l; Blood bilirubin: 0.8 mg/dl; Blood immunoglobulin G: 882; Blood immunoglobulin M: 78; Body mass index: 25.4; Hepatitis viral test: Negative; Liver stiffness measurement: Unknown results; Serum ferritin: 478.12 ng/ml; Transient elastography: CAP 231, notes: kPa - 5.1.; Sender's Comments: Based on the information provided, and a temporal association, a causal association between reported event liver injury and suspect BNT162B2 cannot be excluded. This impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly to regulatory authorities, Ethics Committees, and Investigators, as appropriate., Linked Report(s): US-PFIZER INC-202300195873 Same aticle;suspect;event and different patient;US-PFIZER INC-202300195875 Same aticle;suspect;event and different patient;US-PFIZER INC-202300195874 Same aticle;suspect;event and different patient;
PT NOTICED SWELLING, WARMTH AND REDNESS AT THE SITE OF INJECTION A DAY AFTER THE VACCINE IS GIVEN AND HAS GOTTEN BIGGER.
a secondary inflammatory incident starting on day 9 after the moderna covid vaccine; Swollen arm; itching; Burning; red; A spontaneous report was received from a Consumer concerning of an unknown age, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events swollen arm, red, itching, burning and a secondary inflammatory incident starting on day 9 after the moderna covid vaccine.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On an unknown date, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) via unknown route for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced swollen arm, red, itching, burning and a secondary inflammatory incident that started on day 9 after the moderna covid vaccine.  Treatment details included Ice, Advil  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events-  swollen arm, red, itching, burning, a secondary inflammatory incident that started on day 9 after the moderna covid vaccine- was considered to be unknown.; Reporter's Comments: Very limited information regarding the events has been provided at this time.  Further information has been requested.
Patient received Moderna COVID vaccine on 2/16/21 (lot # 024M20A), 3/20/21 (lot # 001B21A), 11/2/21 (lot # 939904), and 5/23/22 (lot # 057M21A). On 7/19/22, patient admitted to our inpatient facility (med/surg unit) with acute hypoxemic respiratory failure due to COVID-19 pneumonia/infection. Patient was discharged home on 7/22/22.