chrisvoncsefalvay/vaers-outcomes huggingface dataset:
PT FELT WARM AND NAUSEOUS.  PT DENIED ANY CHEST PAIN,  SHORTNESS OF BREATHE OR ITCHING.  PT DID NOT VOMIT.  PT MOVED TO COOL ENVIROMENT AND BEGAN TO FEEL BETTER.  PT OBSERVED BY EMS FOR 15 MIN.  PT SIGNED REFUSAL FOR TRANSPORT TO HOSPITAL.
a decrease in swelling after taking my first dose; Tired; 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 (BNT162B2) (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: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "a decrease in swelling after taking my first dose"; FATIGUE (non-serious), outcome "unknown", described as "Tired".  Additional Information: The patient stated she has been taking Xeljanz for 4 years now. she love the product and states her knuckles in her hand were so swollen before, but she noticed a decrease in swelling after taking her first dose. She stated, she really didn't have any reaction to the first shot. she was real tired, so she slept.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
very sick; In bed sleeping for 2-3 days.; Mega cold like symptoms; Mega cold like symptoms that started with sinus infection.; Very tired for over 7 days; Restless sleep at night; Lots of mucus; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) in the left arm on 15Apr2021 at 11:00 (at the age of 35-year-old) as a dose for COVID-19 immunisation. The patient did not have any relevant medical history. Concomitant medication taken within two weeks of vaccination was not reported. 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. On 17Apr2021 at 11:00, the patient was very sick, in bed sleeping for 2-3 days, mega cold like symptoms that started with sinus infection, very tired for over 7 days, restless sleep at night and lots of mucus. Therapeutic measures were not taken as a result of 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 the events very sick, in bed sleeping, mega cold like symptoms that started with sinus infection, very tired, restless sleep at night and lots of mucus was resolved with sequelae at the time of this report.    No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
I had an adverse reaction to the Pfizer covid vaccine on 06/21/2021. I developed "near syncopic involuntary brain movements" along with blurry vision and strong headaches in the morning. I was admitted to the hospital on 07/16-07/21 no study has been able to find anything wrong however symptoms haven't subsided.
1 of 2 pt rec'd the vax & w/in 48 hrs experienced fever, chills, nausea, vomiting, diffuse muscle aches, large local rxn consisting of redness & tenderness, pt hospitalized;
inadvertently administered an expired Bexsero dose; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 18-year-old male patient who received Men B NVS (Bexsero) (batch number ABXB59AA, expiry date 30th September 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 11th October 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 11th October 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used 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: 11-Oct-2022 Reporter's comment: The pharmacist called to inquire and asked was there any harm to the patient, should they revaccinate.  The registered pharmacist reported they inadvertently administered an expired Bexsero dose (expiry date was September 2022) to a patient.  The reporter did not consent to follow-up. Additional Supportive Information: The patient received expired dose of Bexsero, which led to expired vaccine used.
Pt reports on evening of 05/08/2012 (same day as shot) she had some minor tenderness and a very small red bump at injection site. She reports when she woke up on 05/09/2012 the bump had increased slightly to a little smaller than a dime. She reports she did take 1 Tylenol at that time which helped tenderness for awhile. Pt states by that afternoon she felt chills, very fatigued, mildly feverish and a clear nasal drainage. She said she also was experiencing "sharp pains in throat". Her arm is rather very tender and whole shoulder is tender with movement and touch - rates as a 6 on a 0-10 pain scale. She thinks her bicep area appears swollen slightly, but no redness or warmth outside of dime size bump. Pt did notice yesterday evening/late afternoon she became very itchy all over and she started to develop hives on her chest and lower neck. Today hives have spread to her legs and she "feels as if she has something in her throat". Lips are not swollen, still very fatigued and chills with nasal drainage. Has not taken temperature. She states she does feel a bit short of breath with exertion, more than normal. I discussed normal side effects such as pain, redness, mild swelling and red bump even, but that hives, throat sensation, itching and some dyspnea is abnormal. Pt reports she has called her OB who told her to call HD and to continue Tylenol as needed. I recommended she be seen in urgent care to address breathing concerns. Pt agrees to this and I will follow up with her tomorrow.
Fever, body aches, vomiting, 2" mark around injection site raised, red and hot.
After 1st Moderna immunization, I had an exquisitely sore arm for one week. On or about day 5 or 6 after receiving the vaccine I had swollen and tender supraclavicular lymph nodes. The tenderness lasted for about 3 weeks and the swelling remains. After receiving Moderna Covid vaccine #2 on 2/5/2021, the following 16 hours I experienced diarrhea, nausea, muscle aches, joint pain, headache, and decreased appetite. These symptoms were 98% resolved by the following day (today).
Called pharmacy to report temperature 104 degrees, swollen arm, arm red/hot to touch reported on 9/28/17 at 107 pm.
Swelling, erythema and itching at injection site in Lue - presented to pediatric office 5 days after immunization for eval of sx.
Intern pharmacist vaccinated patient with Moderna vaccine stored outside of refrigerator greater than 24 hours.
feels like trying to go numb but never goes numb; extremely sore and very very painful at the injection site; 101.6 temperature 6-8 hours after the vaccine; tingling in the left arm all the way from shoulder down to fingers; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PARAESTHESIA (tingling in the left arm all the way from shoulder down to fingers), HYPOAESTHESIA (feels like trying to go numb but never goes numb), VACCINATION SITE PAIN (extremely sore and very very painful at the injection site) and PYREXIA (101.6 temperature 6-8 hours after the vaccine) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     The patient's past medical history included Diabetes (stable) on 01-Jan-2021. Concurrent medical conditions included Lung cancer since 22-Aug-2015. Concomitant products included OMEPRAZOLE (PROTONIX [OMEPRAZOLE]) for Acid reflux (esophageal), SERTRALINE HYDROCHLORIDE (ZOLOFT) for Depression, HYDROCODONE for Pain, PEMBROLIZUMAB (KEYTRUDA), ZOLEDRONIC ACID MONOHYDRATE (ZOMETA) and CYANOCOBALAMIN (B12-VITAMIN) for an unknown indication.    On 18-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Mar-2021, the patient experienced VACCINATION SITE PARAESTHESIA (tingling in the left arm all the way from shoulder down to fingers), VACCINATION SITE PAIN (extremely sore and very very painful at the injection site) and PYREXIA (101.6 temperature 6-8 hours after the vaccine). On an unknown date, the patient experienced HYPOAESTHESIA (feels like trying to go numb but never goes numb). At the time of the report, VACCINATION SITE PARAESTHESIA (tingling in the left arm all the way from shoulder down to fingers) had not resolved and HYPOAESTHESIA (feels like trying to go numb but never goes numb), VACCINATION SITE PAIN (extremely sore and very very painful at the injection site) and PYREXIA (101.6 temperature 6-8 hours after the vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Mar-2021, Body temperature: 101.6 (High) For the second dose he had 101.6 temperature 6-8 hours after the vaccine.         Other concomitants include blood pressure medication and Novolin N & R Treatment medicines include  brain MRI (21Apr2021)   This case was linked to MOD-2021-085745 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: Event outcome, reporter causality, med history, con meds
This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 64-year-old female patient who received TWINRIX ADULT (batch number 95KG9, expiry date 29th October 2020) for prophylaxis. On 13th January 2019, the patient received the 1st dose of TWINRIX ADULT. On 13th January 2019, less than a day after receiving TWINRIX ADULT, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved. It was unknown if the reporter considered the pain in arm to be related to TWINRIX ADULT. Additional details were provided as follows: The patient received TWINRIX ADULT in the right deltoid. In the evening after vaccination, the patient experienced arm pain in her entire right arm. The reporter consented to follow up.
Arm was a little sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm was a little sore) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Tooth extraction NOS. Concomitant products included PARACETAMOL (TYLENOL) for Toothache, APIXABAN (ELIQUIS) and CARVEDILOL (COREG) for an unknown indication.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, the patient experienced VACCINATION SITE PAIN (Arm was a little sore). At the time of the report, VACCINATION SITE PAIN (Arm was a little sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested.
expired Menactra was just administered to a patient, no AE; Initial information received on 30-Oct-2019 regarding an unsolicited valid non-serious case received from a non-healthcare professional.  This case involves a patient (with unknown demographics) who received expired vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot number not reported, Exp. Date 09-Oct-2019) via unknown route in unknown administration site on an unknown date.  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.  Information on the batch number was requested.
EXTREME SLEEPINESS AND DROWSINESS; CANNOT KEEP HIS EYES OPEN; REQUIRING 18+ HOURS OF SLEEP PER DAY; DOESN'T WANT TO EAT OR DRINK OR DO ANYTHING
This spontaneous report as received from a medical assistant refers to a patient of unknown demographics. The pertinent medical history and concomitant medications were not reported. On 09-FEB-2015 the patient was vaccinated with a dose of PEDVAXHIB, intramuscular which underwent a supported temperature excursion. No adverse effects were reported. Additional information has been requested.
appendicitis.  Nausea for maybe the week prior, feeling tired,  unwell.  Sunday, May 2, 2021 at noon stomach pain.  Moved into lower right side.  Went to emergency department at 9 p.m. as pain was intense.  CAT scan done.  Inflamed appendix.  Appendectomy done the next morning.
redness at the injection site; Swelling at site of injection; some pain at the injection site; itching at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (redness at the injection site), INJECTION SITE SWELLING (Swelling at site of injection), INJECTION SITE PAIN (some pain at the injection site) and INJECTION SITE PRURITUS (itching at the injection site) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Feb-2021, the patient experienced INJECTION SITE ERYTHEMA (redness at the injection site), INJECTION SITE SWELLING (Swelling at site of injection), INJECTION SITE PAIN (some pain at the injection site) and INJECTION SITE PRURITUS (itching at the injection site). At the time of the report, INJECTION SITE ERYTHEMA (redness at the injection site), INJECTION SITE SWELLING (Swelling at site of injection), INJECTION SITE PAIN (some pain at the injection site) and INJECTION SITE PRURITUS (itching at the injection site) had 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.   no concomitant medications reported. no treatment details reported.   Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: TCR received,patient reported events settled in 3 days and also received second dose.
Patient developed red hard area on arm near immunization site 7-8 days after immunization. Resolved on its own within a few days.
Clinic was informed that patient patient went unresponsive at home at 2pm on 4/21/21 and patient expired.
The facility was not aware of prior doses and a full 3rd dose was given thinking that this was the patient's 1st dose.
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 32-year-old male patient received BNT162b2 (BNT162B2), on 05Mar2021 as dose 1, single (Lot number: Ew0172), in right arm, on 06Apr2021 as dose 2, single (Lot number: Er8737), in right arm and on 17Mar2022 as dose 3 (booster), single (Lot number: FJ5683) at the age of 32 years, in right arm for covid-19 immunisation; diclofenac sodium (DICLOFENAC SODIUM), since 01Jan2022 (Batch/Lot number: unknown). The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "obesity" (unspecified if ongoing). Concomitant medication(s) included: GABAPENTIN, start date: 01Jan2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset May2022, latency 2 months 21 days after the suspect product(s) administration, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jun2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical significance: Patient after taking the Paxlovid and recovering from COVID, he was now experiencing symptoms again and tested positive again. he was currently 6 days post the final dose of the Paxlovid. Patient had no known allergies.  No follow-up attempts are possible. No further information is expected.  Follow-Up (10Jun2022): Follow-up attempts are completed. No further information is expected.
I have been having soreness under my arm. I have checked with other family members (4 females age ranging from 46-58), and they too have the same reactions with soreness under the arm of the injection site.
Hospitalization due to COVID 19. From memory care unit. Reported per Moderna COVID vaccine EUA.
Dizziness, blurred vision and nausea for 5 hours the day following the immunization
room started spinning; broke out into sweat; felt like passing out; dry heaving twice; dizziness; threw up once; nauseous; tired; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (room started spinning), HYPERHIDROSIS (broke out into sweat), PRESYNCOPE (felt like passing out), RETCHING (dry heaving twice) and DIZZINESS (dizziness) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Heart attack (Had 3.). Concurrent medical conditions included Diabetes.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, the patient experienced VERTIGO (room started spinning), HYPERHIDROSIS (broke out into sweat), PRESYNCOPE (felt like passing out), RETCHING (dry heaving twice), DIZZINESS (dizziness), VOMITING (threw up once), NAUSEA (nauseous) and FATIGUE (tired). At the time of the report, VERTIGO (room started spinning), HYPERHIDROSIS (broke out into sweat), PRESYNCOPE (felt like passing out), RETCHING (dry heaving twice), DIZZINESS (dizziness), VOMITING (threw up once), NAUSEA (nauseous) and FATIGUE (tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient reported that she did not take any medication for the symptoms and she also skipped her night time unknown medication. Patient reported that she did not take any medication other morning and put a wet rag on her head.  No specific concomitant medications were reported.
Infant devt. erythema few days after vaccine, at site of admin. Right thigh, then devt. bump which became crusted and more red, no abscess, tenderness, drainage or systemic signs.
Information has been received from a medical assistant referring to multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant therapy were not provided. On unknown dates, the patients were vaccinated with doses of LIQUID PEDVAXHIB (lot#, expiration date, dose and route not reported), which were improperly stored. No adverse effects were reported. Follow up information has been received from an other reporter on 07-JUL-2015 and refers to an 8 weeks old patient of unknown gender. On 03-JUN-2015, the patient was vaccinated with a dose of LIQUID PEDVAXHIB lot # K016965, expiration date 20-JUL-2017. This is one of several reports received from the same source. Additional information has been received. Patient demographics, product and event details and narrative were updated.
Inflammation; This spontaneous case was reported by a consumer and describes the occurrence of INFLAMMATION (Inflammation) in an adult male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect products included non-company products ADALIMUMAB (HUMIRA) solution for injection for Panuveitis and COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) for COVID-19 vaccination.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form, ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose and dose of COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INFLAMMATION (Inflammation). At the time of the report, INFLAMMATION (Inflammation) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Concomitant medications were not reported.  No treatment information was provided by the 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.
The patient received a shingles vaccine (ZOSTAVAX) on 3/12/13 and developed shingles on 9/22/14.
This spontaneous report was received from a pharmacist refers to a patient of unknown demographics. On 04-FEB-2015 the patient was vaccinated with RECOMBIVAX HB (dosing regimen unspecified, lot # unknown; expiry date: 31-JAN-2015). On 04-FEB-2015 expired product administered was reported. Pharmacist reported that an expired dose of RECOMBIVAX HB, exp.31-JAN-2015, was administered today, 04-FEB-2015, to an unspecified patient. No adverse effects reported. No further information provided. The outcome of expired dose of RECOMBIVAX HB administered and no adverse effects reported was unknown. There was no product quality complaint involved. Additional information has been requested.
Transcribing for patient "Both times it was 24 hrs after vaccine. Totally sudden, I thought I was having a stroke. All of sudden top of head felt like it was going to blow off. Thought I had busted a blood vessel. I got dizzy; vision was affected. Both times while driving. Managed not to lose consciousness. Came close. Symptoms lasted for a few hours after the first dose. After the second dose it lasted for 3-4 days and thought about going to the hospital. I took aspirin for the headache, and it helped. I also took niacin to increase blood flow to try and help. I had to lay in bed for a couple of days. I was really scared.
Patient experienced red, raised, puritic rash on left wrist and lower forearm while waiting for the 15 minute observation period.