chrisvoncsefalvay/vaers-outcomes huggingface dataset:
77 patients received Moderna bivalent booster doses that had undergone a temperature excursion; 77 patients received Moderna bivalent booster doses that had undergone a temperature excursion; 77 patients received Moderna bivalent booster doses that had undergone a temperature excursion; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion), PRODUCT STORAGE ERROR (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion), PRODUCT STORAGE ERROR (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion), PRODUCT STORAGE ERROR (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion), PRODUCT STORAGE ERROR (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion).    Concomitant medication was not provided. Treatment medication information was not provided by the reporter. This case contains information for the 41th out of 77 adult patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-696122.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-696122:Master case
received vaccine 12/21 and on 12/29 noted bilateral ear lobe swelling redness and facial flushing. on 12/30/2020 patient reports increased hive like rash on abdomen, trunk arms, and neck redness. Patient seen at her PCP and diagnosed with allergic reaction. Patient has taken benadryl and clariten and symptoms resolving.
Within several minutes of the injection, I noticed a strange taste in my mouth.  A few minutes later my tongue became swollen.  Shortly after that I noticed that swallowing was different than normal.   I was still able to breathe normally but thought I should tell someone.  I notified the person who have me the shot and she told me a nurse practitioner would come talk with me.  I told the NP about the strange taste and that I felt like my tongue was swelling up and that swallowing was more difficult than usual.  She asked me a bunch of questions and then told me she would give me a Zyrtec tablet to take home with me in case I needed it later.  I stayed for another 20 minutes and since it didn't get any worse, I told them I thought I was okay to leave.  I took the Zyrtec when I got out to the car and about an hour later the swelling was gone and swallowing was normal again.   On Monday I notified my PCP of what happened and asked her if I should get the second dose in 3 weeks.  She told me should would consult with an allergist and get back to me.
He develops headaches around noon starting the day after receiving his vaccine with some relief from Tylenol. This has persisted since his vaccination and on Sunday (2 days after) he was feeling so bad he did not even leave his home and just laid around
shot site is purple and looks like blood is under it to the size of a quarter.   Arm hurts , Turned red, hot , rash moving down the arm as the days go by.    It is itching . Have been applying Benadryl cream.     The rash is down by arm almost to the elbow now.     It has been a week since I go the shot.
I started having a rash on R arm & neck. No blisters, but pain & itching in my muscles. Sometimes it would subside & then flash out - lasting 1 month Shingles shot
Feet swelling; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, single), for COVID-19 immunization. The following information was reported: PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "Feet swelling".  Additional information: Consumer called regarding Pfizer product: COVID-19 Shot. He reported his feet swelling, have been swollen up since he got the second shot of the COVID-19 Shot. When he rests them down his feet swell up and he has never had that problem before. He was trying to find out if that a normal side effect of the COVID-19 Shot.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
An anaphylactic reaction to flu vaccine, probably the thimerosal; This spontaneous case was received on 30-Sep-2021 from other non-health professional (consumer) via Med Communications (reference number: SEQW21-03068) and concerned a 40-year-old, female patient.   The patient's medical history and concomitant medications were not reported.  On an unspecified date in 1996, reported as 25 years ago, the patient was vaccinated with influenza virus vaccine polyvalent (brand unspecified; dose, route of administration and anatomical location: not reported) as an influenza prophylaxis. The batch number was not reported.  On an unspecified date in 1996, unknown amount of time after receiving influenza virus vaccine polyvalent, the patient experienced anaphylactic reaction to flu vaccine, probably to the thimerosal.   The outcome of the event was not reported.  The reporter assessed the event of anaphylactic reaction to vaccine to be related to influenza virus vaccine polyvalent. As reported, the patient had an anaphylactic reaction to flu vaccine, and she had not had a flu vaccine in 25 years because of the reaction.  The events of 'anaphylactic reaction to vaccine' was considered to be medically significant by a Physician within Seqirus' Pharmacovigilance and Risk Management Department.  Company comment: A 40-year-old patient was vaccinated with influenza virus vaccine polyvalent. An unknown amount of time after receiving vaccine, the patient experienced anaphylactic reaction. Causal role of the suspect vaccine is unassessable, due to unclear temporal relationship.; Reporter's Comments: As reported, the patient had an anaphylactic reaction to flu vaccine, and she had not had a flu vaccine in 25 years because of the reaction.; Sender's Comments: A 40-year-old patient was vaccinated with influenza virus vaccine polyvalent. An unknown amount of time after receiving vaccine, the patient experienced anaphylactic reaction. Causal role of the suspect vaccine is unassessable, due to unclear temporal relationship.
G45.9 TRANSIENT CEREBRAL ISCHEMIA 4/12/2023 DIASTOLIC HEART FAILURE, ACUTE ON CHRONIC G45.9 TRANSIENT CEREBRAL ISCHEMIA 4/12/2023 HYPERVOLEMIA G45.9 TRANSIENT CEREBRAL ISCHEMIA 4/12/2023 PULMONARY HTN
This spontaneous report as received from a medical assistant refers to an unknown number of patients of unknown age and gender. Information about concurrent conditions, concomitant medication and medical history was not provided. Since 12-AUG-2014, an unknown number of patients were vaccinated with improperly stored single dose PNEUMOVAX 23 (lot#, dose, dose number and route were unspecified). No adverse effect was noted. This is one of several reports received from the same reporter. Follow up information has been received from the office manager regarding the patients. The office manager was able to share the lot# K009105 (expiration date 21-JAN-2016) for the PNEUMOVAX 23 that experienced a temperature excursion. The office manager had no patients' information or dates of vaccination available to share at this time. This is one of several reports received from the safe office manager. Additional information has been requested.
Child's parents scheduled a COVID vaccine appointment online and entered and confirmed the date of birth of 2009 (12 years). However, today (11/01/21), dad called and said that the date of birth on the vaccine card is incorrect. The child's real DOB is 2011 (10 years). This information was not given to the pharmacy at the time of vaccine administration. Pharmacist ensured child's name and DOB with the parent and they confirmed it as 2009 at the time of vaccine administration. Explained to mom that her daughter is outside of the age group for this vaccine but as per the date of birth provided at the time of giving the vaccine made her eligible for this vaccine.
Injection pain, fatigue, headache, severe muscle pain, chills, joint pain, fever, nausea, diarrhea, vomiting
PT C/O CHEST PAIN AND SOB POSITIVE COVID TEST ON 7/22/21
Child developed redness and swelling of whole left upper arm   with local warmth. no abscess or discharge or tender at vaccine site. Clinical diagnosis of cellulitis and prescription give for cephalexin antibiotics with 2 days follow up.
Narrative:  Documenting VAER as required for pt who died and received COVID vaccine months before.
Patient was brought to ER after paramedics were called by her family PCP for low 02 sats. Patient had been recently admitted and diagnosed with PNA. Her last admission Covid test had been negative, however, this admission Covid test was positive. Admitted for acute hypoxic respiratory failure secondary to Covid PNA. Patient was given steroids, vitamins, and Remdesivir. Hospitalization complicated by nausea and vomiting, imaging suggestive of ileus. At time of discharge, walk test was done and patient was discharged home on 2L O2.
Patient received moderna vaccine on 4/16/21 and 5/19/21. Presented to ER on 1/19/22 and found to be COVID positive. Admitted. Presented to the ED with complaints of productive cough with greenish sputum.  Patient was recently discharged on January 15, 2022 for sepsis secondary to UTI, was sent home with cefpodoxime for 2 more days.  Patient said that when he got home on day of discharge yet await also for few hours.  I was asked today he began having a productive cough of greenish sputum,   Complains of chills, nausea without emesis, loose watery stools, and poor oral intake in that same time period. Patient states that his symptoms have been progressively getting worse in the last few days. Pt denies chest pain, fever and known ill contacts. He lives at home with his sister and niece.   In the ED, pt had a fever initially; Temp of 101.5F, BP 118/61, HR 76, RR 20 and was saturating at 95% on 3L of oxygen. Pt does not use oxygen at home. UA was ordered, HS troponin was 22.1. Procal of 0.18, CRP of 122, CMP unremarkable except for CRT of 1.4. BNP, Blood Clx, Urine Clx, Sputum Clx, Chest X-Ray - revealed mild interstitial prominence, may reflect interstitial edema. Strep, legionella pending. Pt tested positive for Covid-19. Chest CT revealed evidence of covid-19 Pneumonia, no acute PTE  He was given Rocephin 1g, and was admitted for management of his Covid-19 pneumonia. REceived remdesivir, azithromycin and ceftriaxone. DIscharged on 1/22/22. He was subsequently discharged home with azithromycin 250mg for atypical pneumonia 2 more days to be completed on 01/23/2022. Pt was also discharged on decadron 6mg. To take until 01/26/2022  He was discharged on 6mg on 01/22/2022, 6mg on 01/23/2022 Pt is to have INR rechecked on 01/24/2022.
This spontaneous report as received from a pharmacist refers to a 66 year old female patient. The patient's medical history included hospitalization. The patient's past drug history was unknown. On 16-DEC-2014 the patient was vaccinated with dose 1 of PNEUMOVAX 23 (dose 1, 0.5 ml, intramuscular; lot number reported as K010465 EXP 23-MAR-2016) for inpatient status. On 17-DEC-2014 the patient was vaccinated with dose 2 of PNEUMOVAX 23 (dose 2, 0.5 ml, intramuscular; lot number reported as K010465 EXP 23-MAR-2016) for inpatient status. On 20-DEC-2014 the patient was vaccinated with dose 3 of PNEUMOVAX 23 (dose 3, 0.5 ml, intramuscular; lot number reported as KD19386) for inpatient status. Concomitant therapies included ANUSOL cream, ATIVAN "PRN", CARAFATE, CENTRUM, potassium 20 milliequivalent daily, MEGACE suspension 400 mg, NICODERM 21 g patch daily, PROMOD powder 7 g  three times a day, PROTONIX 40 mg daily, RESTORIL 15 mg at bedtime, thiamine, XANAX 0.25 mg every 6 hours "PRN", acetaminophen, PERCOCET 5/325 "PRN" and NOVOLOG sliding scale. The patient was vaccinated 3 times with PNEUMOVAX 23 in four day. No laboratory data was reported. It was unknown if the patient will continue to take PNEUMOVAX 23. Additional information has been requested.
Given HPV injection approx. 8:20 a.m., Immediately felt sick and dizzy, thought she was going to vomit. There were two more incidents during day one; she said she felt more fatigued than usual and after waking up the second time after the vaccination had severe frontal head pain accompanied with dizziness. This is being reported on day two, patient says she continues to be dizzy and in general feels ill.
No breathing difficulties. Caller reports that child woke up the next morning with skin around the vaccination site described as hot, red and raised. The redness spread from the injection site to the shoulder and down to the elbow. Child was taken to HCP today for treatment.
itchy rash all over the body; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (itchy rash all over the body) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced RASH PRURITIC (itchy rash all over the body). The patient was treated with SALICYLIC ACID (EUCERIN [SALICYLIC ACID]) at an unspecified dose and frequency. At the time of the report, RASH PRURITIC (itchy rash all over the body) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were reported.  Company Comment: 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.   Most recent FOLLOW-UP information incorporated above includes: On 02-Aug-2021: Follow-up contains Non-Significant Information.; 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.
CHILLS, NASAL CONGESTION, DRY COUGH, HOARSENESS, SHORTNESS OF BREATH WITH EXERTION, FATIGUE
Lethargic; Stomach feeling nauseous; Headaches; Shortness of breath; Dizzy on and off; A spontaneous report was received from a consumer who was a 45-years-old, female patient who received Moderna's COVID-19 vaccine and experienced shortness of breath, headaches, stomach feeling nauseous, dizziness on and off, and lethargy.  The patient's medical history, as provided by the reporter, included post-nasal drip.  No relevant concomitant medications were reported.  On 26 Dec 2020, the patient experienced post-nasal drip.  On 30 Dec 2020 at approximately 1600PM, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.     On 30 Dec 2020, after receiving the mRNA-1273 vaccination, the patient experienced shortness of breath (SOB). She reported SOB to be not urgent. The patient also developed headaches, nauseous feeling in the stomach, and dizziness on and off.   On 01 Jan 2021, she experienced lethargy and continued headaches. The patient's blood pressure was reported as normal.  Treatment for the events included taking deep breaths, drinking almost a liter of water a day, ibuprofen for headaches and saline drops for post-nasal drip.  Action taken with the second dose of mRNA-1273 in response to the event was not reported. However, the patient expressed hesitancy in obtaining the second dose.  The outcome for the events, shortness of breath, headaches, stomach feeling nauseous, dizziness on and off, and lethargy, were unknown.; Reporter's Comments: This case concerns a 45-year-old female patient who received their first of two planned doses of mRNA-1273 (Lot unknown), and who experienced the non-serious listed events of nausea and headache, and the non-serious unlisted events of shortness of breath, dizziness, and lethargy.  Based on the current available information and temporal association between the use of the product and the onset of events starting  on the day of vaccination, a causal relationship cannot be excluded and the events are considered possibly related to the vaccine.  However, the presence of post-nasal drip prior to vaccination and persistence of symptoms may be due to an undiagnosed viral illness.
Pain from shot location migrated up arm into the shoulder and neck and down upper part of shoulder blade and back. Was not able to turn my head left sometimes the pain took my breath away. It took six days for the pain to go away.
immediately following vax pt devel erythematous area about 8cm diameter @ inject site; this was 1 of 3 similar reactions w/in 3hr period of time;
soreness at injection site; Fatigue; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In 2018, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced injection site pain and fatigue. On an unknown date, the outcome of the injection site pain and fatigue were recovered/resolved.   It was unknown if the reporter considered the injection site pain and fatigue to be related to Shingrix.     Linked case(s) involving the same patient:  US2022AMR116707   Additional Information: GSK Receipt Date: 08-AUG-2022. Reporter's Comments: The patient received 1st doses of Shingrix in 2018.  The reporter stated that the patient experiencing soreness at injection site and fatigue after 1st dose. Did not consent to follow-up. For tolerance of 2nd dose refer case US2022AMR116707.; Sender's Comments:  US-GSK-US2022AMR116707:Same report
Malaise; Headache; This spontaneous case was reported by a pharmacist and describes the occurrence of MALAISE (Malaise) and HEADACHE (Headache) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (Malaise) and HEADACHE (Headache). At the time of the report, MALAISE (Malaise) and HEADACHE (Headache) outcome was unknown.        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 information was reported. No treatment medications were provided.   This case was linked to MOD-2021-370462 (Patient Link).
After one week of getting shot rash on right arm is back. Additionally I start to feel that my arm goes numb constantly. I can move it but I feel pins and needles.
3RD DOSE MODERNA COVID VACCINE GIVEN 11/17/21, #0985995; 4TH DOSE MODERNA COVID VACCINE GIVEN 6/7/22, #057M21A; Positive COVID test 8/30/22 at local hospital; developed MRSA bacteremia,given ABX; 9/27/22 transferred back to SNF (Quality Center for Rehab and Healing at the SNF; pt passed away in SNF
pt recv vax 6SEP91 & devel encephalopathy r/t the viral encephalitis (non vector);pt also exp sz;pt states MD would not give record of vax;pt has pending workers compensation case since 1991;
double dose of fluzone quad with no adverse event; Initial information received on 01-Nov-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 12 years old female patient who received double dose of Influenza quadrival A-B vaccine [Fluzone Quadrivalent] with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 02-Sep-2022, the patient received a dose 1 of Influenza quadrival A-B vaccine, suspension for injection (lot UT7683JA; Expiry date. 30-Jun-2023) via intramuscular route in the right arm  and  on 31-Oct-2022 she also received a dose 2 of the same vaccine (lot UT7683JA; Expiry date. 30-Jun-2023) via intramuscular route in the right arm for immunization double dose of fluzone quad with no adverse event (extra dose administered).  Action taken : not applicable.  Outcome : Unknown.   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 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.
Mother calls to report patient was seen at urgent care due to rash/hives on bilateral arms, chest & back