chrisvoncsefalvay/vaers-outcomes huggingface dataset:
5/1/07 3:30 pm PC from client. States she woke up at noon today with a swollen, red face and "red spots all over both legs. Had received HPV immun on 4/30/07 in the afternoon went to express care at 1:00 pm and was seen by Dr states she was given Benadryl pills and steroid cream.
Tachycardia with palpitations for 6 hours post vaccination, diarrhea
Information has been received from a health professional concerning a patient who was vaccinated with varicella virus vaccine live. Subsequently the patient developed chicken pox. Unspecified medical attention was sought. No product quality complaint was involved. No additional information available at this time. Additional information has been requested.
This spontaneous report was received from a pharmacist refers to multiple patients of unknown age and gender. Concurrent conditions and medical history were not reported. On unspecified dates, the patients were vaccinated with improperly stored (temperature excursion: 34.3F, time frame: 10 hours) doses of VAQTA with lot/batch # L014265, expiry date 28-APR-2017 (dose, dose number, vaccination site and route of administration not provided). Concomitant therapies were not reported. The previous temperature excursion was reported as 48.4F for 7 hours. Product quality complaint (PQC) was not involved. This is one of three reports received from the same reporter. Additional information has been requested.
This spontaneous report was received from a pharmacist and refers to a currently 76 year old male patient with hypertension. The patient did not have drug reactions or allergies and concomitant medications included losartan (AUROBINDO). On unknown dates, the patient may have received two doses of PNEUMOVAX 23 for prophylaxis, within a week from each other. The pharmacist reported lot # N025656 and expiration date on 19-APR-2019, but was not able to clarify if lot number and expiration date were the same for both doses of the vaccine (dose, route of administration and anatomical location were not reported). The pharmacist stated that the second vaccination should have been BOOSTRIX. On an unknown date, the patient reported that his arm was hurting. There was no treatment given for the adverse event, no lab diagnostics or studies were performed and the patient did not sought medical attention. The outcome of pain in the arm was unknown. The pharmacist did not provide a causality assessment between this event and the vaccination with PNEUMOVAX 23.
neuropathy; This is a spontaneous report from a contactable Nurse. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. Reporter called about Covid vaccine and has a question connected to the AE he has reported. Wants to know if neuropathy is a side effect of the vaccine. Event outcome was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Very limited information was provided in this case, pending further details such as medical history, clinical course, specified event description, at this moment, the mentioned neuropathy is considered related to BNT162B2 for reporting purpose.   The 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 notified to RA, as appropriate.
With 2 minutes the nurse recognized signs of allergic reaction: localized redness swelling, hives, itching. She applied an ice pack to the swelling and retrieved a doctor who immediately treated with Benadryl and watched for signs of respiratory distress.
tongue really swollen; Sore throat; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. A 45-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: er8730), via an unspecified route of administration in the right arm on 01Apr2021 at 10:00 (at the age of 45-year-old), dose 1, single for COVID-19 immunisation. Medical history included hysterectomy in 2013 and her throat was closing up, and they think it was the pain medication in the hospital and had a reaction to Tramadol and Vicodin. The patient stated that she did not know if the vaccine and pain medications would have something similar in them. Family history included mother died of lung cancer. There were no concomitant medications. The patient previously took tramadol; hydrocodone bitartrate paracetamol (VICODIN) and had unspecified reaction. The patient had no history of previous immunisation with the COVID-19 vaccine. The patient did not administer additional vaccines on same date of the COVID-19 vaccine. The patient did not receive any vaccine within 4 weeks prior to COVID-19 vaccine. The patient stated she had the first shot on 01Apr2021 at pharmacy and on 02Apr2021, she woke up in the morning and her tongue was really swollen and she had sore throat. Nothing too severe, but she could feel it when she swallows. The patient called the pharmacy and they told her to take Benadryl. The patient had only been up for a couple hours and just took 25 mg of Benadryl at 09:00. They told her if she had trouble breathing then to go to the hospital. The reporter would like to know if there was anything else to do regarding their side effects other than what the pharmacist advised her, should she go to her primary care physician. The patient did not undergo lab tests and procedures. The patient did not visit emergency room or physician office for the events. The outcome of the events was not recovered.  No follow-up attempts are possible; No further information is expected.
pt recv 3rd dose of vax 24APR95 & was found to be a nonresponder;
arm was kind of sore, like after a flu shot (1st dose); swelling of face and eyes (1st dose); all face swollen for 2 days (1st dose)/ swelling of face and eyes (1st dose); This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (arm was kind of sore, like after a flu shot (1st dose)), EYE SWELLING (swelling of face and eyes (1st dose)) and SWELLING FACE (all face swollen for 2 days (1st dose)/ swelling of face and eyes (1st dose)) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (arm was kind of sore, like after a flu shot (1st dose)), EYE SWELLING (swelling of face and eyes (1st dose)) and SWELLING FACE (all face swollen for 2 days (1st dose)/ swelling of face and eyes (1st dose)). At the time of the report, PAIN IN EXTREMITY (arm was kind of sore, like after a flu shot (1st dose)) and EYE SWELLING (swelling of face and eyes (1st dose)) outcome was unknown and SWELLING FACE (all face swollen for 2 days (1st dose)/ swelling of face and eyes (1st dose)) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient reported that symptoms started after 24 hours. Included sore arm, swelling of face and eyes. At  the beginning it was only on the right side but then all face was swollen. This lasted 2 days.  No concomitant medications reported by reporter No treatment medications provided by the reporter.   This case was linked to MOD-2021-430637 (Patient Link).
Upper (R) arm swollen and red and warm to the touch; s/s started on 11/5/13 at approx 4 pm; s/s have not gotten worse today; pt advised to take ibuprofen, BENADRYL et ice packs for 24 hrs; RTC if s/s persist or worsen.
Hives all over body gave benadryl they went away came back, gave benadryl went away came back, gave again never went away its been 4 days now still getting hives.
HCP states they are unable to clarify if the patient received the full dose schedule or not, as they are not clear what product the patient received.; No additional AE information provided.; This spontaneous report was received from Licensed Practical Nurse and refers to a currently 38-year-old male patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 27-APR-2011, the patient was vaccinated with first dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) intramuscular injection, administered for prophylaxis (lot number 0732z expiration date 11-DEC-2012, strength and route of administration were not provided). On 27-MAY-2011, the patient was vaccinated with second dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) intramuscular injection, administered for prophylaxis (lot number 0732z expiration date 11-DEC-2012, strength and route of administration were not provided). It was unable to clarify if the patient received the full dose schedule or not, as they are not clear what product the patient received (product dose omission issue). No additional adverse event information provided.
11 hrs after shot I had a very bad case of diarrhea.  A day later my left arm muscle was very sore (not the injection site, the whole upper arm muscle).  Three weeks after the shot, my arm is still very sore and I can hardly use my left arm.  It's very painful to get dressed, take off a jacket, shirt, etc.  I can hardly use the left arm to hold anything due to the pain in the muscle.
Rash developed on arm opposite of injection site, spread across entire body; Swelling under his arm; lymphadenopathy; Mildly feverish; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of RASH (Rash developed on arm opposite of injection site, spread across entire body) and LYMPHADENOPATHY (Swelling under his arm; lymphadenopathy) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, the patient experienced LYMPHADENOPATHY (Swelling under his arm; lymphadenopathy) (seriousness criterion hospitalization). On 15-Apr-2021, the patient experienced RASH (Rash developed on arm opposite of injection site, spread across entire body) (seriousness criterion hospitalization) and PYREXIA (Mildly feverish). At the time of the report, RASH (Rash developed on arm opposite of injection site, spread across entire body), LYMPHADENOPATHY (Swelling under his arm; lymphadenopathy) and PYREXIA (Mildly feverish) had not 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.   Concomitant medication include unknown Inhalers, Blood pressure meds, cholesterol and cough medicine  Patient was treated with IV steroids for an unrelated condition; however, physician believes patient might see some benefit.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
On 6/22/01, pt received Hep-B and 1 hour later, he had rapid breathing. Two hours later, he had increased fever and was lethargic with malaise. On 6/23/01, he was admitted to the hospital with increased fever. His appetite was somewhat decreased. Exam completely normal.
Fast heart rate. Difficulty breathing - had to use inhaler through the night. Rt upper outer arm - swollen/red/raised/hard area at injection site. (VARIVAX)
Vaxelis was administered after a temperature excursion to a patient. No additional AE reported. Temperature:8.8C. Time Frame:54 minutes; This spontaneous safety report, with reference number 02355015 (Interaction # 02354956) was received by the partner on 16-MAR-2023 and forwarded on 17-MAR-2023, from a health professional.    Due to the nature of the event, the causality between the event "Vaxelis was administered after a temperature excursion to a patient. No additional AE reported. Temperature:8.8C. Time Frame:54 minutes" and Vaxelis was not applicable.  Further information is expected.
expired dose Fluzone HD administered, no AE; Initial information received on 24-Sep-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to cases 2019SA268346, 2019SA268355, 2019SA268356, 2019SA268357 and 2019SA268358 (same reporter).  This case involves a 87 years old male patient who received 0.5 ml dose of expired vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (lot UI994AA, Exp. Date 09-Apr-2019) via intramuscular route in the right deltoid, on 13-Sep-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of actual medication error due to expired vaccine used.  At the time of reporting, no adverse reactions were 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.  List of documents held by sender: none.
received expired dose of the Moderna COVID19 vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received expired dose of the Moderna COVID19 vaccine) in a 95-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 059h21a) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Mar-2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 28-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (received expired dose of the Moderna COVID19 vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received expired dose of the Moderna COVID19 vaccine) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported. It was reported that vial did not undergo any temperature excursions and the vial was initially stored in the refrigerator on 25-Mar-2022.   This case was linked to MOD-2022-533291, MOD-2022-534346, MOD-2022-534411, MOD-2022-534418, MOD-2022-534426, MOD-2022-534434, MOD-2022-534458.
FEVER, COUGH, SINUS PROBLEMS ED to Hosp-Admission Discharged   8/17/2021 - 8/23/2021 (6 days) Hospital Pneumonia due to COVID-19 virus
R ARM felt numb down to the hand. Swollen where the vaccine was given. It didn't hurt and not warm. Ice compress applied with improvement of symptoms.
Client vaccinated with Moderna vaccines for Covid in beginning and end of February (cannot recall dates). Client symptomatic for Covid and tested positive on 8/20/2021.  Reported as breakthrough Covid in a fully vaccinated person.
MMR-V given instead of varicella - total of 3 MMR's for pt. No side effects reported from pt.
Back pain; Fever; chills; Headache; Nausea; Fatigue; This is a spontaneous report from a Non- Contactable consumer (patient). A 25-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection) via an unspecified route of administration in left arm on 29Jan2021 at 08:30 (age at vaccination 25-year-old) as dose 1, single for Covid-19 immunization. The patient's medical history included Covid-19. Prior to vaccination, patient was diagnosed with COVID-19. Patient did not have any known allergies. The patient's concomitant medications were not reported. Patient did not receive any other vaccine in four weeks. Patient did not receive any other medications in two weeks. Patient did not test for Covid-19 post vaccination. Patient took Covid-19 vaccine in left arm on 23Feb2021 as dose 2 for Covid-19 immunization. On 29Jan2021 at 08:30 patient experienced fever, chills, back pain, headache, and nausea. Worst of it lasted 24 hours. headache, fatigue, and back pain persisted for 2- 3 days following. Patient did not receive any treatment for adverse events. The outcome of event was recovered on an unspecified date in 2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt was given Tdap (BOOSTRIX) in (R) arm. Pt had immediate hive at injection site (right arm). Redness area measured 12 cm in length x 7 cm wide with welt measuring 6 cm in length. Pt was given 25 mg of BENADRYL 30 mg. Prednisone immediately. Pt waited 20 minutes & was given ice for the affected area. After 20 minutes the welt decreased & pt left w/instructions to call us if he needs to.
aches; itching; kind of tired; This is a spontaneous report from a contactable consumer (patient).  A 72-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EL9262, expiry date unknown) in the doctor's office, via an unspecified route of administration on 27Jan2021 at a single dose on the right arm as she was over 65, for COVID-19 immunization. Medical history included ongoing diabetes mellitus a long time ago since she was in her 60's, ongoing blood pressure, ongoing high cholesterol and cyst. Concomitant medication included ongoing losartan (manufacturer unknown) for blood pressure, ongoing pravastatin (manufacturer unknown) for high cholesterol, metformin (manufacturer unknown) for diabetes mellitus from an unspecified date to an unspecified date and ongoing sitagliptin (JANUVIA) for diabetes mellitus. The patient was also prescribed an unspecified antibiotic for a cyst which was taken 2 weeks before the vaccination. The patient did not have prior vaccinations within 4 weeks of the COVID vaccine. The patient experienced itching on 27Jan2021, the same day as the Covid 19 shot later in the day, after she got home. She didn't pay attention to it. The next evening she called her doctor and told him about it and he said it was one of the side effects of the Covid 19 shot and prescribed Benadryl. She started the Benadryl that same night, 28Jan2021. She should not have waited, she should have called the doctor the same day. She called the pharmacy and got the prescription, it's not that far for her. The patient stated that the the itching lasted a couple of days, it is gone, as of an unspecified date. She took Benadryl for the itching, it is the best thing for her. In all, she thinks she went through 2 to 3 days of the whole situation. The patient also stated that she took Tylenol for the aches and that got better. She had aches but the aches from the Covid 19 shot started on 28Jan2021. On the day of the report, she was a lot better. The aches went away but does not recall what day they went away. She feels much better that day. The aches were not severe. She added that the aches and itching lasted for 2-3 days and are totally improved, that they stopped on an unspecified date. State she was able to go outside that day. She added that she was kind of tired. She had to lay down one day because the itching and aches were bad. The outcome of the event kind of tired was recovering while the outcome of the other events was recovered on an unspecified date in 2021.
Patient started getting a tingling sensation on the tongue and nausea within 20 minutes of receiving vaccination. Followed within 12 hours by nausea, fever and chills. Went away within 24 hours, but has never had this reaction before. Had received Fluzone HD previously, but never Fluad
Information has been received from a registered nurse referring to a patient of unknown age and gender. The patient's concomitant medication, medical history and drug reactions/allergies were not reported. On 21-JUL-2015, the patient was vaccinated with the first dose of GARDASIL 9 (lot# and expiration date were not reported, 0.5 mL, intramuscular) for prophylaxis. On 30-DEC-2015, the patient was vaccinated with the second dose of GARDASIL 9 (lot# and expiration date were not reported, 0.5 mL, intramuscular). On 10-MAR-2016, the patient was vaccinated with the third dose of GARDASIL 9 (lot # K010215 (non-valid), expiration date unknown, 0.5 mL, intramuscular) (Product use issue). No adverse effects were reported. Additional information has been requested.
Vaccine breakthrought.   Inpatient admit 8/25-8/29/21
Fatigue, headache, chills, muscle aches, difficulty sleeping- moderate enough to disrupt daily routine- felt the same as I did when I actually had covid 19
Patient developed puritic rash on neck and upper torso the evening of administration. Pt. given KENALOG 40 mg 1/30/18.
Swelling, redness & warmth at vaccine site, positive itch.  Rx: Zyrtec 10 mg qd prn, cool compress.
Recalled Lot  Product was administered; Recalled Lot  Product administered; This case was reported by a other health professional via call center representative and described the occurrence of recalled drug administered in a patient who received HBV (Engerix B pediatric) (batch number CP23D, expiry date unknown) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Engerix B pediatric and Engerix B Pre-Filled Syringe Device. On an unknown date, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced recalled drug administered and drug dispensing error. On an unknown date, the outcome of the recalled drug administered and drug dispensing error were 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: 26-May-2022 Reporter's Comments: The vaccine coordinator reported a dose of Engerix-B from recalled Lot Product was administered to patients. The patients were administered this lot number but no adverse event reported. The reporter inquired what information should they send to patient regarding Engerix recall from back in October 2021. The reporter did not consent to follow-up. Additional Supportive Information: The patient received engerix B from recalled Lot which led to recalled drug administered and drug dispensing error. This is one of 10 cases reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022084603:Same Reporter US-GLAXOSMITHKLINE-US2022AMR085025:Same Reporter US-GLAXOSMITHKLINE-US2022AMR085031:Same Reporter US-GLAXOSMITHKLINE-US2022AMR085030:Same Reporter US-GLAXOSMITHKLINE-US2022AMR085029:Same Reporter US-GLAXOSMITHKLINE-US2022AMR085026:Same Reporter US-GLAXOSMITHKLINE-US2022AMR085027:Same Reporter US-GLAXOSMITHKLINE-US2022AMR085028:Same Reporter US-GLAXOSMITHKLINE-US2022AMR085033:Same Reporter
Seizure on 10-17-07 at 9:30am & 11:30am.  Tx with incr. dosages of Phenobarbital & Tegretol.