chrisvoncsefalvay/vaers-outcomes huggingface dataset:
induration; erythema; localized pain; This case was reported by a physician via call center representative and described the occurrence of injection site induration in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced injection site induration, injection site erythema and injection site pain. On an unknown date, the outcome of the injection site induration, injection site erythema and injection site pain were unknown.   It was unknown if the reporter considered the injection site induration, injection site erythema and injection site pain to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient.  The age at vaccination was not reported but it could be 67 years or 68 years. The patient received Shingrix 1st dose 5 to 6 months ago. Afterwards, he experienced a large induration, localized pain and redness which scattered 3 to 4 inch from injection site.  The patient did not state when the symptoms were occurred, how long they lasted and if they subsided. The patient asked that, was this a contraindication to receive the 2nd dose of Shingrix.
Sore arm mild at first, by day 3 arm felt like it was run over by a truck. 4th day was fine. Mild headache throughout several days.  Body aches similar to flu aches that start the day following the injection and last about 2 days total. Not severe.
102 degree fever Chills Headache Took three doses of Tylenol over 16 hrs; symptoms subsided with Tylenol and time
A large local reaction; This spontaneous case was received on 12-Nov-2020 from physician via Communications (reference number: SEQW20-05057) and concerned an adult, female patient. The patient's age at the time of reporting was 24 years.   The patient's medical history and concomitant medications were not reported. The patient reported having a large local reaction to Flucelvax (influenza vaccine, subunit influenza virus vaccine polyvalent) back in 2019.   On unspecified date in 2020, the patient was vaccinated with influenza virus vaccine polyvalent (brand not specifed, indication, dose, anatomical location and route of administration: not reported). The batch number was not reported. The reporter was unsure if this year's vaccine was even Flucelvax.   On unspecified date in 2020, a few days after receiving influenza virus vaccine polyvalent, the patient was having a large local reaction.   The outcome of the event was not reported.  The reporter assessed the event as not related to influenza virus vaccine polyvalent. The reporter did not think this time it was related to the vaccine.  This case is linked to 202006324 (the same patient).  Company comment:The patient developed local reaction several days after vaccination with the suspect product, influenza virus vaccine polyvalent. Chronology is plausible. The patient's medical history and concomitant medications were not reported. Considering all above mentioned, causal relationship is assessed as possibly related (defaults to ''related'' in the safety database for reporting purposes).; Reporter's Comments: The reporter did not think this time it was related to the vaccine.; Sender's Comments: The patient developed local reaction several days after vaccination with the suspect product, influenza virus vaccine polyvalent. Chronology is plausible. The patient's medical history and concomitant medications were not reported. Considering all above mentioned, causal relationship is assessed as possibly related (defaults to ''related'' in the safety database for reporting purposes).
The injection itself was painless however the three days after I had severe pain through my left arm and needed my right arm to help move it around that lasted about 3 days. I took Arnica and it seemed to help. The evening of Jan. 14th I started getting a pain on my forearm down to my wrist and this lasted only till the 15th. On the 18th about 8pm I got nauseated and threw up about 5 times within 2 hours. I had antinausea meds left over that I took that made it stop. The nausea came with a headache at the back of my neck where it meets the head. I also had three days  (till the 20th) in bed with server body-ache that I described like getting in a car accident all over your body.  The headache lasted the week till the 24 and was subdue by Advil for headache.
Sickness; Food poisoning; Vaccination site swelling/ Swelled up after took moderna booster shot; This spontaneous case was reported by a consumer and describes the occurrence of FOOD POISONING (Food poisoning), ILLNESS (Sickness) and VACCINATION SITE SWELLING (Vaccination site swelling/ Swelled up after took moderna booster shot) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect products included non-company products ADALIMUMAB (HUMIRA) for Crohn's disease and TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    No Medical History information was reported.   On 12-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form On an unknown date, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form., ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form and dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (Intramuscular) 1 dosage form. On 12-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE SWELLING (Vaccination site swelling/ Swelled up after took moderna booster shot). On 16-Nov-2021, the patient experienced FOOD POISONING (Food poisoning). On an unknown date, the patient experienced ILLNESS (Sickness). In November 2021, FOOD POISONING (Food poisoning) and VACCINATION SITE SWELLING (Vaccination site swelling/ Swelled up after took moderna booster shot) had resolved. At the time of the report, ILLNESS (Sickness) had resolved.            It was unknown if she was enrolled in a COVID-19 Vaccine Trial. No concomitant medication information was provided. Vomiting and Diarrhea were symptoms of Food poisoning.  On an unknown date, the patient experienced sick after took COVID 19 Pfizer vaccine.  The reporter's causality for the event(s) of Food poisoning, arm Swelled up after took Moderna booster shot and Sick after took covid 19 PFIZER vaccine with Humira(adalimumab) was no reasonable possibility. The reporter's causality for the event(s) vomiting and diarrhea was not provided.  The reporter's causality for the event(s) of Food poisoning, vomiting, diarrhea, Vaccination site swelling with PFIZER BIONTECH COVID-19 vaccine was not provided and with Sickness was not related.  No treatment medication information was provided.  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
it was warm to touch; has about the size of their fist; vaccination site on their arm it's sore and it really hurts; vaccination site on their arm is burning; arm began to swell at the injection site; arm began to turn red at the injection site; had a rash that itched at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (it was warm to touch), CONDITION AGGRAVATED (has about the size of their fist), VACCINATION SITE PAIN (vaccination site on their arm it's sore and it really hurts), VACCINATION SITE SWELLING (arm began to swell at the injection site) and VACCINATION SITE ERYTHEMA (arm began to turn red at the injection site) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A and 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Breast cancer (Patient can not have e shot in left arm because many lymph nodes were removed due to  breast cancer. Ans it was advised that patient should have the next vaccine on right thigh.). Concurrent medical conditions included Drug allergy. Concomitant products included PRAVASTATIN from 06-Jan-2020 to an unknown date for Cholesterol.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Mar-2021, the patient experienced VACCINATION SITE SWELLING (arm began to swell at the injection site), VACCINATION SITE ERYTHEMA (arm began to turn red at the injection site) and VACCINATION SITE PRURITUS (had a rash that itched at the injection site). On 22-Mar-2021, the patient experienced VACCINATION SITE WARMTH (it was warm to touch), CONDITION AGGRAVATED (has about the size of their fist), VACCINATION SITE PAIN (vaccination site on their arm it's sore and it really hurts) and VACCINATION SITE PAIN (vaccination site on their arm is burning). On 30-Mar-2021, VACCINATION SITE SWELLING (arm began to swell at the injection site), VACCINATION SITE ERYTHEMA (arm began to turn red at the injection site) and VACCINATION SITE PRURITUS (had a rash that itched at the injection site) had resolved. At the time of the report, VACCINATION SITE WARMTH (it was warm to touch), CONDITION AGGRAVATED (has about the size of their fist), VACCINATION SITE PAIN (vaccination site on their arm it's sore and it really hurts) and VACCINATION SITE PAIN (vaccination site on their arm is burning) outcome was unknown.            No treatment medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Follow-up information received on 11-May 2021 VAERS concomitant medication, medical history and new events were added and action taken was updated.
vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine given 6 days post expiry) in a 47-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment medications were not provided by the reporter.   This case was linked to MOD-2021-395985 (Patient Link).
Took Vivotif incorrectly / took Vivotif two days in a row; Spontaneous report received on 13JAN2020.  A female consumer reported that she "took Vivotif incorrectly / took Vivotif two days in a row" (PT: Inappropriate schedule of product administration). She was receiving Vivotif for immunization. It was reported that the consumer took Vivotif incorrectly. She took Vivotif two days in a row. She took first dose of Vivotif on 12JAN2020 at 08:00 am, and took second dose on 13JAN2020 at 07:30 am. Action taken with Vivotif with respect to the reported event was not applicable. The outcome of the reported event was unknown.  Company Comment: A consumer took first and second doses of Vivotif two days in a row instead of taking them on alternate days (Inappropriate schedule of product administration). Considering the nature of the event, the causality of Inappropriate schedule of product administration is assessed as not applicable to Vivotif.; Sender's Comments: A consumer took first and second doses of Vivotif  two days in a row instead of taking them on alternate days (Inappropriate schedule of product administration). Considering the nature of the event, the causality of Inappropriate schedule of product administration is assessed as not applicable to Vivotif.
Myalgia, NauseaVomiting, Arm sore, chills, fatigue Narrative:
Dizziness, Headache, Myalgia, NauseaVomiting, Fatigue, chills, Right ear pain, dizziness, fuzzy vision, Right sided numbness Narrative:  Employee reported fatigue, chills, myalgia, severe right ear pain (drilling like sensation), dizzines, nausea, vomiting and right sided numbness / tingling. CT completed - suspected intracranial bleeding. Transferred to local ED for care and management.
evening arm became sore; PM became nauseated, aching; 4PM began vomitting, & fainted @ 6PM; abdo cramps, diarrhea began; shaky weak, but better;
EPISODE OF POOR SUCKING,PALNESS AND APPARENT DISTRESS APPORXIMATELY 6 HR AFTER IMMUNIZZTION.ALSO SLEPT AND THEN HAD A 5 MIN EPISODE OF APPRARENT STARTTLE AND GASP. RESOLVED WITH TYLENOL AND OF 2-3 HOURS  ,  EXAM 9/10/08 WNL EXCEPT FOR INJECTION TRACTS IN LATERAL THEIGHS.
Shingles; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 1 week after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient receive dthe vaccine and one week later developed shingles.  He was still an active case of shingles.  No additional details were available. The reporter consented to follow up. This case has been linked with US2020220495, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020220495:same reporter
Night after vaccines (L) arm, pt had low fever, chills, body aches. Next day aches, fever, vomiting & redness/rash at site. Next 2 days decreased pain but increased redness, heat, pain in arm at site. Today site is flat & less red/sore but area distal is red, raised, hot, very painful to touch.
patient was administered moderna covid 19 vaccine and with 10 minutes developed shortness of breath, nausea and vomiting, and seizures X3. ems was dispatched and patient was taken to hospital for further evaluation
The day after receiving the shot I began having muscle aches, a fever of 102.5, and a severe throbbing and buzzing in my ears (right ear has been worse than left). I called on the 28th, (2 days after receiving the shot) when the fever and pain did not subside. The "evisit" call was horrible where the medical professional wrote off the symptoms as a side effect which most people were suffering from.  The fever lasted 4-5 days, the ear aches and buzzing are reoccurring and have not subsided. I also find myself sluggish more frequently. I am 53 and, up until this point, extremely healthy and in good shape. The pain in my ears is the problem. It is hindering my ability to stay focused, sleep at night and is resulting in vertigo often.
Strong, flu-like symptoms starting 4 hours after administration (arthralgias, myalgias, fatigue, weakness, headache), persisting for 24 hours then easing off to mild flu-like symptoms.
Sore left arm; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (received 1st dose on 9th January 2020, refer case US2020078681.).   On 15th March 2020, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced pain in arm. Rechallenge with Shingrix was positive. 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 Shingrix.  Additional details were provided as follows: The patient received Shingrix and experienced a sore arm and it has lasted for months and yet not recovered. The reporter consented to follow up.  This case linked with US2020078683, reported by same reporter.
Fever 4 days - 103-104.  Rash all over body/smooth very irritable.
Information has been received from a physician concerning a patient who was vaccinated with 0.5 ml of Gardasil. subsequently the patient experienced stomach pain after receiving the vaccine. The patient's outcome was not reported. Medical attention was sought. Additional information has been requested.
Patient reports that she was tired for 2 days after her second dose of the Moderna Covid-19 vaccine.; This spontaneous case was reported by a patient and describes the occurrence of FATIGUE (Patient reports that she was tired for 2 days after her second dose of the Moderna Covid-19 vaccine.) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 016M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FATIGUE (Patient reports that she was tired for 2 days after her second dose of the Moderna Covid-19 vaccine.). On 14-Mar-2021, FATIGUE (Patient reports that she was tired for 2 days after her second dose of the Moderna Covid-19 vaccine.) had resolved.            No Concomitant product use was reported.  No treatment information was provided.   This case was linked to MOD-2022-585875 (Patient Link).
Edema in upper Left Deltoid/Tricept region.  POS errythema, SKIN- hot to touch.  PT complains that area is throbing.  Streaking from proximal to distal on L Upper arm.  Area in question is rigid.
Pt developed swelling and erythema at the site of the immunization with pain and tenderness over the deltoid muscle and in the axilla.
Day 2-Day 5: High fever, breathing issues, fatigue, loss of appetite... Day 11- High fever, fatigue, aches, asthma.
low immunity to type C and W; Initial information received on 28-Jun-2019 regarding an unsolicited valid non serious case received from a nurse.  This case involves a 21 years old male patient who experienced low immunity to type c and w, while he received vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].  The patient's past vaccination(s), concomitant medication(s) and family history were not provided.   He is on immunosuppressant for Crohn's disease  On 07-May-2009, the patient received a first dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot via unknown route in unknown administration site. On 30-Apr-2014 he also received second dose of the same vaccine lot U4610BA and expiry date: 14-Jan-2015 via intramuscular route in the right arm.  On an unknown date, following the vaccination the patients antibody levels drawn and they were immune to a lot of things. A patient had low immunity to type C and W.  (Other relevant tests included no lab data.)  Final diagnosis was antibody test negative.  It was not reported if the patient received a corrective treatment.  The outcome of the event was not applicable at the time of reporting.  List of documents held by sender: none.
COVID+ 10/24/22.  Vaccination status - Moderna x3 BRIEF OVERVIEW: Discharge Provider: MD Primary Care Provider:  MD Admission Date: 10/24/2022 Discharge Date: Oct 29, 2022   Active Hospital Problems   Diagnosis Date Noted POA ? Pseudomonal pneumonia   10/29/2022 Yes ? Acute on chronic respiratory failure   10/24/2022 Yes ? COVID-19 10/21/2022 Yes  DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Acute on chronic respiratory failure   [J96.20] Acute on chronic respiratory failure with hypoxemia   [J96.21] Pneumonia due to COVID-19 virus [U07.1, J12.82]   HOSPITAL COURSE: Patient is a 77 yo male with PMHx of chronic respiratory failure on 4 liters continuously at baseline, group 3 pulmonary HTN, chronic diastolic heart failure, CAD, CKD stage 3a and OSA. He presented to the ED after being found to have hypoxia at outpatient Remdesivir infusion appointment. He had developed symptoms of COVID-19 about 5 days prior to presentation.    In the ED he was noted to be hypoxic on his normal 4 liters of oxygen, requiring titration to 6 liters. CXR was obtained which demonstrated mild patchy airspace disease of both mid to lower lungs. He was given IV Decadron and Duo-Neb with admission to the medicine service for acute on chronic hypoxic respiratory failure secondary to COVID-19 PNA.   # Acute on Chronic Hypoxic Respiratory Failure Secondary to COVID-19 PNA # Superimposed Bacterial PNA Secondary to Pseudomonas He was initially treated with Decadron (10/24-10/27) and Remdesivir but oxygen requirements failed to improve significantly. Therefore he was switched to IV Solu-Medrol (10/27-10/29). Sputum culture grew Pseudomonas and was started on Cefepime during hospitalization. He completed 2 days of Cefepime prior to discharge. Oxygen requirements improved and was able to wean down to baseline 4 liters of oxygen at rest. During his hospitalization, he was also placed on pharmacological VTE prophylaxis. It was recommended patient stay to monitor stability once transitioned back to oral steroids, but patient requested discharge which was not unreasonable. He was discharged on 5 days of Ciprofloxacin to complete treatment for pseudomonas and 60 mg of Prednisone to decrease by 10 mg every 3 days. Pulmonary rehab evaluated patient and recommended increasing oxygen upto 6 liters with activity   Patient was discharged home in stable condition and discharge instructions provided
Injection site was swelling and itching; Injection site was swelling and itching; site is very red with minor swelling; Feeling "tired but not lethargic"; Her head "was a little fuzzy that morning and I didn't want to get up, and I wasn't hungry"/Brain fog; Injection site reactions including pain, redness, swelling, and itching; she may have an infection at the injection site; Felt off: described as fuzzy in head, no ambition, not hungry, but she could taste.; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 75-year-old female patient received first dose of BNT162B2 (COMIRNATY, solution for injection, Lot number was not reported), via an unspecified route of administration on 03May2021 as DOSE 1, SINGLE for covid-19 immunisation. Medical history included osteoporosis from an unknown date and unknown if ongoing, (she was diagnosed 5 years ago. she was diagnosed with a bone density test), latex allergy from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. After first dose of COMIRNATY on 11May2021 patient experienced injection site was swelling and itching, site was very red with minor swelling, feeling "tired but not lethargic", her head "was a little fuzzy that morning and she didn't want to get up, and she wasn't hungry"/brain fog, injection site reactions including pain, redness, swelling, and itching, she may have an infection at the injection site, felt off and described as fuzzy in head, no ambition, not hungry, but she could taste on an unspecified date in 2021. The outcome of the event vaccination site pruritus was recovering, foggy feeling in head was recovered on 12May2021 and unknown for another events.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.