chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Client received vaccines in a sitting position at 2:15pm. After administration, this nurse asked client how they were feeling and if she was feeling lightheaded at all. Client stated she felt good and not lightheaded. Client stood and waited in room while brother received vaccinations. At 2:20 pm, banging noise occurred in room. This nurse viewed client sitting on ground with eyes closed. When this nurse approached client, she woke up. Client was oriented to person and place. Able to speak clearly. Ice pack placed on back of neck while cot being set up. Client transferred to cot and legs placed in bent position. Blood pressure taken at 2:24pm as 100/70, pulse 100BPM. Client alert. Red bump appeared on left side of forehead. Ice pack placed on forehead. Client stated she was feeling nauseas. at 2:27pm, pulse was 72BPM.  at 2:31pm, blood pressure reading was 100/60 and pulse was 72 while laying on back with legs bent. at 2:35pm, client was able to sit up and drink juice. Stated she was not nauseas anymore. Client transferred to sitting position in chair at 2:38pm. Alert and Oriented to person, place, time, and situation. Blood pressure was 100/78 and pulse 80BPM. Client stated she was not feeling light headed or nauseas. Able to stand on own and walk on own. This nurse walked client out to car at 2:50pm.
Dizzy Tue, Wed, Thurs and increasing. Notice it when he turns head to either side esp.  when holding head to one side. Otherwise feels fine, no headache, no nausea, no cramps , not off balance. Has flushing of face also, oft and on X 3 days.
diarrhea daily; headache; chills; shortness of breath; feeling tired; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea daily), HEADACHE (headache), CHILLS (chills), DYSPNOEA (shortness of breath) and FATIGUE (feeling tired) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007B21A and 007B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Cortisol high.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (diarrhea daily), HEADACHE (headache), CHILLS (chills), DYSPNOEA (shortness of breath), FATIGUE (feeling tired) and CORTISOL INCREASED ("cortisol level was high"). At the time of the report, DIARRHOEA (diarrhea daily), HEADACHE (headache), CHILLS (chills), DYSPNOEA (shortness of breath) and FATIGUE (feeling tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported. No treatment medication or therapy reported.   Most recent FOLLOW-UP information incorporated above includes: On 02-Jul-2021: Significant follow-up appended
Patient currently admitted at (40 days inpatient starting on 11/22/2021. Patient is a 64 y.o. female fully vaccinated against COVID 19 (Pfizer, 2nd dose in June) now presents with COVID-19 infection and SOB. PMHx significant for ESRD s/p DDRT, immunosuppression with (prograf, myfortic, prednisone), chronic pericardial effusion, IDDM-II, GERD, HTN.   Patient tested positive for COVID-19 on 11/17. 1 week of cough, diarrhea, fevers, chills. Seen in ED on the 19th, discharged with albuterol inh. This morning feeling more short of breath so returned to the ED.    In the ED hemodynamics were stable. She was hypoxic on RA in the 80s, required 2 L NC. Labs with elevated CRP otherwise fairly unremarkable.  D-dimer elevated at 940.
Received a phone call today with patient stating that since the flu vaccine, she has been experiencing inflammation and reddish, itchy rash around the injection site. The inflammation has subsided but still has a rash and is sensitive.  No other symptoms are noted and it has been two weeks since.
On 12/18/2022 I was tired that evening and had a little bit of a cough. When I woke up the next day, I had a cough, and was achy and tired. I have a history of bronchitis, so coughs are not abnormal, but I never get a dry cough, and this was a dry cough. I then started feeling feverish. I tested myself for COVID-19 by the end of that day and it was positive. I contacted my doctor's office through a telehealth visit. They prescribed me PAXLOVID. I had a couple days of fever that spiked up to 102 along with coughing, congestion, aches and pains. I had some balance issues as well. I stopped all of my other medications while taking the PAXLOVID. The symptoms only lasted a few days except for the congestion. I took another at home COVID-19 test that Friday and it was negative. I confirmed those results with a PCR test before joining my family for Christmas that Sunday. My daughter informed me on 12/26/2022 that she was positive for COVID-19. I tested myself again on 12/27/2022 and was positive again. That time, I did not take PAXLOVID. At some point, I developed some sort of adverse taste, and everything tasted awful. I could still smell, but my taste was totally altered and that lasted a couple of weeks.
Few macules, few turning papular, faintly vesicular on neck and back, itchy. Rash developed while at school. Sent home seen in our office on 02/01/2002 at 4 pm.
4 month-old child received FLUZONE QUADRIVALENT, no AE; Initial information regarding an unsolicited valid non-serious case was received from a nurse via Medical Information inbound (reference number- 00625248) and transmitted to Sanofi on 02-Jun-2021.  This case involves a 4 month old (gender not reported) patient who was administered 0.5ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (lot number and expiry date: not reported) via unknown route in unknown administration site for prophylactic vaccination on 02-JUN-2021 (Product administered to patient of inappropriate age).  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medication' and family history were not provided.  It was a case of an actual medication error due to inappropriate age at vaccine administration (latency same day).  At the time of this report, no adverse events 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 2001/3/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.   There will be no information available on the batch number for this case.
First, the tech wasn't going to change the gloves that he was wearing for the last several people because his "hands get sweaty and it's hard to put new ones on." Second, he forgot to swab my arm with alcohol.  I did remind him and the swab time was approx 1.5 seconds which seemed very short. Lastly, as the J&J booster vaccine was being administered, the needle fell off of the syringe.  The tech was surprised and said I received most of the vaccine. He was also checking patients in as he was preparing the syringes.
5 days after the second  Moderna vaccine shot  woke up with muscle aches arms and pain at the top of the spine and at the bottom.  Muscle aches added in the legs within a week.   I had very stiff/tight muscles in my legs.  I have been a life long runner and I have never had trouble with my leg muscles.  I also had inflammation in my body but especially lower legs and feet.   I also seemed to have problems with dehydration which also is unusual for me.  The  symptoms varied a lot from day to day and week to week.  Not until July did I  finally  have enough improvement  to start jogging again and now  in early August my legs are back to normal but my arms still ache more it should with exercise.  No fever and I did not go to a doctor.
irregular heartbeat; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE IRREGULAR (irregular heartbeat) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEART RATE IRREGULAR (irregular heartbeat). At the time of the report, HEART RATE IRREGULAR (irregular heartbeat) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided . Treatment information was not provided.
Swelling, redness, heat, itchiness and hardness at injection site that did not appear until one week after the vaccine.
Soreness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Soreness at the injection site) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (Relevant medical history not reported).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Soreness at the injection site). At the time of the report, VACCINATION SITE PAIN (Soreness at the injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication use was not reported.   Treatment information was not reported.
Moderna Covid-19 vaccine expired on 01-Apr-2022 was initially stored in the refrigerator on 04-Mar-2022; Patient received expired Moderna COVID-19 Vccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna COVID-19 Vccine) and PRODUCT STORAGE ERROR (Moderna Covid-19 vaccine expired on 01-Apr-2022 was initially stored in the refrigerator on 04-Mar-2022) in a 57-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 09-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna COVID-19 Vccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Moderna Covid-19 vaccine expired on 01-Apr-2022 was initially stored in the refrigerator on 04-Mar-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna COVID-19 Vccine) and PRODUCT STORAGE ERROR (Moderna Covid-19 vaccine expired on 01-Apr-2022 was initially stored in the refrigerator on 04-Mar-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  The vials were initially stored in refrigerator on 04-Apr-2022. The vial has not undergone temperature excursion.  It was reported that the pharmacist thought that the expiry date of the vaccine was Jun-2022, However the vaccine expired on 01-Apr-2022.  No treatment medication was provided.
Intense redness, swelling, and warmth approx 4-6 hours after injection site. Fatigue, swelling, and redness lasting >72-96 hours
Narrative:  pt died on 10/18/2022 from HEART ATTACK (MYOCARDIAL INFARCTION) at home. Pt had the following past medical history in chart: N40.1 Benign prostatic hyperplasia (SCT 266569009) N52.8 Erectile dysfunction (SCT 860914002) F14.10 Cocaine abuse (SCT 78267003) 786.2 Cough (ICD-9-CM 786.2) 356.9 Unspecified idiopathic peripheral neuropathy (ICD-9-CM 356.9) I10. Benign essential hypertension (SCT 1201005) 272.4 Hyperlipidemia (ICD-9-CM 272.4) E11.65 DM - Diabetes mellitus (SCT 73211009) B18.2 Chronic hepatitis C (SCT 128302006) Pt had received a covid-19 EUA (J&J) vaccine on 8/20/2021. It appears this death is NOT RELATED TO THE COVID VACCINE given the long length of time between the date vaccine was given & the date of pt's death.
redness that was about 3 inches and it was hot to the touch and swollen; redness that was about 3 inches and it was hot to the touch and swollen; redness that was about 3 inches and it was hot to the touch and swollen; lump on her arm that was itchy; lump on her arm that was itchy; Soreness; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE WARMTH (redness that was about 3 inches and it was hot to the touch and swollen), VACCINATION SITE INDURATION (lump on her arm that was itchy), VACCINATION SITE PRURITUS (lump on her arm that was itchy), MYALGIA (Soreness) and VACCINATION SITE ERYTHEMA (redness that was about 3 inches and it was hot to the touch and swollen) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).    On 15-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 15-Jan-2021, the patient experienced MYALGIA (Soreness). On 22-Jan-2021, the patient experienced VACCINATION SITE INDURATION (lump on her arm that was itchy) and VACCINATION SITE PRURITUS (lump on her arm that was itchy). On 24-Jan-2021, the patient experienced VACCINATION SITE WARMTH (redness that was about 3 inches and it was hot to the touch and swollen), VACCINATION SITE ERYTHEMA (redness that was about 3 inches and it was hot to the touch and swollen) and VACCINATION SITE SWELLING (redness that was about 3 inches and it was hot to the touch and swollen). The patient was treated with CEFALEXIN MONOHYDRATE (KEFLEX [CEFALEXIN MONOHYDRATE]) ongoing since an unknown date at an unspecified dose and frequency and VALACYCLOVIR [VALACICLOVIR] ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (redness that was about 3 inches and it was hot to the touch and swollen), VACCINATION SITE INDURATION (lump on her arm that was itchy), VACCINATION SITE PRURITUS (lump on her arm that was itchy), MYALGIA (Soreness), VACCINATION SITE ERYTHEMA (redness that was about 3 inches and it was hot to the touch and swollen) and VACCINATION SITE SWELLING (redness that was about 3 inches and it was hot to the touch and swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided Treatment Keflex and Valacyclovir
Patient was sitting at the time of vaccination. Patient then stood waiting against the wall for less than 5 minutes after administration before her eyes had rolled back, she lost consciousness and fell to the floor. Patient's mother immediately picked her up into her lap and patient regained consciousness after a minute. She was able to speak and tell us her name, location, and describe any pain. Patient reported having a slight pain in the center of her forehead, some dizziness, but no other weaknesses. Paramedics were called and after examining and measure patient's vitals, they determined she was stable. Patient's mom refused any hospital visit or further treatment.
04/07/21 at 1205 Pt. sitting in Vaccination monitoring area post first dose Pfizer vaccine (lot ER8733); noted to be tearful with hand over chest. Voiced "feels like heat is beating fast all of a sudden". 1207 Pt. moved to monitoring cot into semi - reclined position. 1208 BP 140/82, HR 103, O2 sat 99%, R 20. Skin slightly clammy with no skin redness / rash or throat / tongue edema. 1208 EMS called to site. Pt denies medical hx or any allergies. 1213 Pt. voiced "HR starting to feel better, only notes some lightheadedness / spacey feeling; P 91 / Sat 98%. 1215 BP 132/78, P 65, R 18, Sat 98% - Voiced "thinks everything is okay now; notes only dull ache at right arm injection site. Pt. also called husband to site at time. 1217 EMS arrives and pt. assessed. 1226 EMS provided pt. education on self monitoring & hospital f/u. Pt. declines transport to hospital; will monitor self at home with assist of husband: sitting on side of cot. 1228 EMS departed scene and pt. husband now present; P - 61 and O2 98%. 1229 Pt. and husband voiced readiness to leave. Educated to let pt. PCP know about events post vaccination. Pt. voiced understanding and will just monitor self at home. Both ambulated to from site together
vaccines that are administered but have been deemed not suitable for use, the vaccines were on the truck on thursday but didn't arrive to them until around 11 am/No AE; Initial information received on 24-Sep-2019 regarding an unsolicited valid non-serious case received from a consumer (office staff).  This case is linked to cases 2019SA267341, 2019SA267336, 2019SA267344, 2019SA267345 and 2019SA267346 (same reporter).  This case involves a 59 years old male patient who received 0.5mL dose of vaccines INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE] (lot UJ223AA, expiry-30-06-2020) via intramuscular route in the right deltoid on 23-Sep-2019.  It was a case an actual medication error due to incorrect product storage.  Caller is saying the vaccines were on the truck on Thursday but didn't arrive to them until around 11 AM but they did not hear until late in the day not to use them stating they received a message around 4:20 PM. Caller states as soon as they arrived she started giving injections and feels they should have been told earlier in the day that the vaccines shouldn't have been given.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
1st, cramping legs, 2nd- nausea-3rd-very tired- 4th sm headache-5th sore body,-  6th next day (4-8-21)  right armpit lymph node hurts- swollen
Adverse effect of other vaccines and biological substances, initial encounter on 2021-12-11.
Treatment of COVID-19; Treatment of COVID-19; Covid 19 positive. Appears to be Rebound; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Dec2020 at 15:30 as dose 1, single (Lot number: EK9321), in left arm, on 15Jan2021 at 11:00 as dose 2, single (Lot number: EL3246), in left arm, on 26Oct2021 at 11:00 as dose 3 (booster), single (Lot number: EW0217), in left arm and on 14Apr2022 at 11:30 as dose 4 (booster), single (Lot number: FK9729) at the age of 64 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing). No Known allergies. There were no concomitant medications. The following information was reported: DISEASE RECURRENCE (medically significant) with onset 15Aug2022 at 09:00, outcome "not recovered", described as "Covid 19 positive. Appears to be Rebound"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (Aug2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 included Paxlovid. Therapeutic measures were not taken as a result of disease recurrence.
Patient started developing a red itchy rash around the injection site and down her arm to her elbow beginning 5 days post immunization.
Pruritic rash and wheals at injection site and distal to injection site that commenced 7 days after the injection and lasted for 7 days. Finally subsided with topical antibiotic and steroid creams.
After 8 days of vaccination the area of application is swollen as a dime size, red, itchy and hot to the touch. Day 9 the swollen area is larger than a quarter, hard, swollen, itchy and warm to the touch.  Taking antibiotics for a UTI and piridium plus acetaminophen.
Patient presented to the ED with shortness of breath, admitted for further evaluation and treated with remdesivir.
Second moderna injection made breathing worse; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Second moderna injection made breathing worse) in a 21-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product DUPILUMAB (DUPIXENT) for Asthma.    Concurrent medical conditions included Asthma.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and DUPILUMAB (DUPIXENT) (Subcutaneous) 600 milligram. On an unknown date, DUPILUMAB (DUPIXENT) (Subcutaneous) dosage was changed to 300 milligram every two weeks. On an unknown date, the patient experienced DYSPNOEA (Second moderna injection made breathing worse). At the time of the report, DYSPNOEA (Second moderna injection made breathing worse) outcome was unknown.            No concomitant medications were reported.  The second Moderna injection made his breathing worse and needed to use his nebulizer today, 06Aug2021  This Case was Identified as part of retrospective email clean-up activity which included identification and booking-in of historical emails. This activity has been described in deviation #QE-019993.
This spontaneous report as received from a pharmacist refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with the improperly stored (from 47 to 77 degrees Fahrenheit for 14 hours) doses of PROQUAD (lot # L050910, expiration date 14-JUN-2017; dose and route of administration were not reported) for prophylaxis. The vaccines were reconstituted with the properly stored sterile diluent. No adverse effect and previous excursion were reported. The call was made because of the data logger. This is one of two reports received from the same reporter. Additional information is not expected as the reporter did not wish to be contacted. Sender's Comments: US-009507513-1705USA009034.
Patient received Covid vaccine L deltoid on 11/12/21 and 12/3/21.  Had covid illness in early May 2022.  Shortly thereafter noticed lump in left upper arm.
pt recvd vax & 10 mins p/vax became dizzy, cold & clammy, devel a tired rt arm, & passed out; all events w/in 45 mins;