chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a physician refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD injection, lot # M042497, expiration date on 17-APR-2018 (dose and route of administration were not reported). The vaccine was reconstituted with properly stored sterile water diluent. There were no adverse effects reported. Administered doses of vaccines experienced the temperature excursion from 6 degrees Fahrenheit to 14 degrees Fahrenheit for 1 hour and 10 minutes and from the second excursion 15 degrees Fahrenheit to 46 degrees Fahrenheit for 2 hours and 15 minutes. Data logger was involved in recording the excursion details. There were no previous excursions reported. No product quality complaint was involved. This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-1709USA006448:
Seven hours after patient received shot there stomach became painful, then got chills with nausea.  24 hours later sinuses were draining and spirting out a lot of slime.  36 hours later patient was spitting yellow slime.  Patient started taking antibiotics available at home. Patient sick for 3 weeks
NauseaVomiting pain, redness, swelling, itchy injection site, fatigue Narrative:
8 days after injection I woke with a very itchy, red and swollen arm where the injection had been given
Bowel movement the morning after the vaccine - about 24 hours later- was a fairly bright red - very unusual color. Wiping afterward revealed bright red blood on tissue.   Did not continue to bleed and subsequent bowel movements were normal.
Hurting Injection Site; Fever 100 F; Aches all over; No Appetite; Sick to her Stomach; A spontaneous report (United States) was received from a consumer concerning a 73-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events hurting injection site/Injection site pain, fever 100 f/Pyrexia, aches all over/Pain, no appetite/Decreased appetite, sick to her stomach/Abdominal discomfort.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 6 Mar 2021, approximately 2 days prior to the onset of the events the patient received their second planned dose of mRNA-1273 (lot/batch: 010A21A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 7 Mar 2021, the patient experienced the events hurting injection site. fever 100 f, aches all over, no appetite, sick to her stomach. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not applicable.  At the time of this report, the outcome of events, hurting injection site, fever 100 f, aches all over, no appetite, sick to her stomach was considered as unknown.
chills; coughing; upset stomach; headache; This is a spontaneous report from a contactable consumer or other non HCP. This consumer reported for a 83-year-old female patient (grandmother).  A 83-year-old female patient received first dose of bnt162b2 (BNT162B2; Solution for injection; Lot number: UNKNOWN), via an unspecified route of administration as dose 1, single on 03Feb2021 (at the age of 83-year-old) for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. As per reported, reporter brought the patient to receive the first dose of the COVID vaccine on 03Feb2021 and seemed fine that day. Patient started to experience chills, coughing, upset stomach and a headache two to three days ago on unspecified date in Feb2021. Reporter would like to know if these symptoms are normal and associated with the vaccine, how long will patient's symptoms last and what to do about side effects. At the time of this report, outcome of the events was unknown.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Patient was given wrong vaccine. Our provider, drawn the wrong vaccine, instead of Moderna Bivalent 12+, she administered the primary dose for Pedia Moderna.
Strain; sick; This case was reported by a consumer via interactive digital media and described the occurrence of strain in a patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   The patient's past medical history included smoker.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced strain and sickness. On an unknown date, the outcome of the strain and sickness were unknown.   It was unknown if the reporter considered the strain and sickness to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The age at vaccination was not reported. It was reported that the patient did get a flu shot, and came down with strong strain. The patient was so sick that the patient quit or stopped smoking.
My husband has red patches (about the size of dimes) - essentially a rash, on his neck and on his stomach since 2 days after his second dose.  He has not received any treatment.   The day after his 2nd dose he was in bed all day with muscle aches, fatigue, headache, etc. that resolved within 24 hours.
Started with throat and chest tightness, followed by cough and unable to catch breath, wheeled to ER given nebulizing treatment, 0.3mg of Epi, 50 mg IV Benadryl and 125mg IV solumedrol, chest tightness, tachycardia, and cough seemed to abate for aprox 15 minutes before return of symptoms, but worse. HR 140-150, BP 180/104, tachypneic  high 30's, feeling like unable to breath, throat did not close, duoneb inhalant treatment  given with 02, sx seemed to calm after 15 minutes. Pt d/c home after 3 hours in ER with bp 138/98, HR 134, 20 resps, SP02 @ 97%. SP02 never dropped below 95% throughout severe allergic reaction
This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Feeling sick), HEADACHE (Headache) and FATIGUE (Fatigue) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis. No Medical History information was reported. On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. On an unknown date, the patient experienced MALAISE (Feeling sick), HEADACHE (Headache) and FATIGUE (Fatigue). At the time of the report, MALAISE (Feeling sick), HEADACHE (Headache) and FATIGUE (Fatigue) had not resolved. It was unknown if patient was enrolled in a COVID-19 vaccine trial. No concomitant medications were reported. No treatment medications were reported. 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. This case was linked to MOD-2021-624364 (Patient Link).
vaccine administration error: interval. Doses administered on 8/28/2021 and 9/11/2021. less than 17 days between doses.
Pt's mother states pt developed swelling and redness on left arm for 3 days, and fever. Administered Tylenol and salt compress. Non tender.
This spontaneous report as received from a female patient of unknown age regarding herself. On an unknown date in early August 2013, the patient was vaccinated with a dose of ZOSTAVAX (lot#, expiry not reported). On an unknown date within the last week on an unknown date in September 2013, the patient experienced shingles-like symptoms which included burning on her left side in the area of lower hip. Patient sought medical attention-spoke with unspecified pharmacist. The outcome of shingles-like symptoms which included burning on her left side in the area of lower hip was reported as recovering. Additional information has been requested.
(L) deltoid is mildly erythematous, warm, approx 4" x 5", non-tender, no local reactive lymphadenopathy - recommend ice/ibuprofen.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2021 at 10:04 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 17-Feb-2021 at 10:04 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 73.13 for dose administered on 17-Feb-2021.  No concomitant medications were reported.  Batch number 022M20A underwent temperature excursion on 17-Feb-2021 with temperature 20 degrees Fahrenheit at 08:00 AM and 22 degree Fahrenheit at 09:00 AM. This vial was moved to fridge on 11-Feb-2021 and BUD date for the vial was reported as 13-Mar-2021. Product moved to clinic on 17-Feb-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  No treatment medications were reported.
"Lightheaded", "woozy", "stressed that may play a role" @ 1524 BP 168/100 HR 68 SPO2 97% RA, @1527 BP 161/87, @1532 BP 158/84, @1538 BP 151/97 Narrative: Report provided to this RN by staff, monitor post Covid vaccination: @1524 (Post 15 min monitoring after receiving vaccination) Employee reported to staff, monitor, a mild feeling of being lightheaded or "woozy" and stated " have been a bit stressed regarding news and uncertain if that is playing a role, vitals were taken. Employee agreed to stay for another 15 mins, @1538 last BP taken and Employee stated she felt better. Symptoms resolved and employee was able to go.
Breakthrough case admission after 5 vaccines  Moderna 1/14/21 lot# 012L20A;  Moderna 2/11/21 Lot# 010L20A;  Moderna 11/17/21 lot# 939909;  MOderna 5/18/22 lot# 056M21A;  Moderna 10/19/22 lot# 062F22A
Glandular swelling under left arm pit; Glandular swelling under left arm pit and on left thigh; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Glandular swelling under left arm pit) and LYMPHADENOPATHY (Glandular swelling under left arm pit and on left thigh) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0321321A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, the patient experienced LYMPHADENOPATHY (Glandular swelling under left arm pit) and LYMPHADENOPATHY (Glandular swelling under left arm pit and on left thigh). At the time of the report, LYMPHADENOPATHY (Glandular swelling under left arm pit) and LYMPHADENOPATHY (Glandular swelling under left arm pit and on left thigh) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Dec-2021, SARS-CoV-2 test: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  The patient reported that she had a procedure done in June 2021 and therefore did not receive the second dose.  No treatment information was provided.
I had my injection, the evening of 1/13 at 430PM, and about 2 hours later and generalized nausea.      That morning upon waking at 0500 I was dry heaving, running a low grade fever with a mild headache and chills and my arm was in a significant amount of pain/throbbing.        My symptoms did not even really begin to alleviate until Friday 1/16 and were not completely gone until 1/17.
Tinnitus, very loud ringing/buzzing in ear; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in the arm right on 10Mar2021 at 12:00 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included losartan (MANUFACTURER UNKNOWN) , prasterone (DHEA) , pregnenolone (MANUFACTURER UNKNOWN) , progesterone (MANUFACTURER UNKNOWN) and estradiol (ESTRAD). Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 14Mar2021 at 00:00, the patient experienced tinnitus, very loud ringing/buzzing in ear. The patient did not receive any treatment for the event. 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 event tinnitus, very loud ringing/buzzing in ear was not resolved.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Had COVID symptoms one and a half weeks after the first dose; This is a spontaneous report from a contactable consumer. This report was received via a sales representative. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE,Formulation: Solution for injection, Lot Number: Unknown), via an unspecified route of administration on an unspecified date at a single dose (1ST DOSE, SINGLE) for covid-19 immunization. Medical history included breast cancer (Ten year). Concomitant medication included letrozole. The patient had covid symptoms one and a half weeks after the first dose on an unspecified date. The outcome of the event was recovered on an unspecified date.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Arm was hot (from shoulder to elbow) swollen, unbearable to touch for 4 days on 5th day start, it started to improve, and it was very itchy.
injection site with swelling, redness,warmth, tender to touch/ also began vomiting, and neck pain on left
vesicle rash in various stages of healing more dense in diaper area & back scattered lesions on scalp & trunk;high pitched irritated cry;MD recommends DPH cream;
doctor mistakenly administered only the diluent portion of pentacel vaccine, no AE; Initial information received on 29-Apr-2020 regarding an unsolicited valid non-serious case from a nurse.  This case involves a 7 months old male patient who was vaccinated only with the diluent portion of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (third dose, 0.5 ml, lot number 6469AA, expiration :03-Nov-2020) mistakenly by a doctor, via intramuscular route in the right leg on 16-Mar-2020 as prophylactic vaccination.  The medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS B VACCINE (HEPATITIS B VACCINE); ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ); and PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for prophylactic vaccination.  It was an actual medication error case due to  active ingredient not added to diluent.  No adverse event reported at the time of reporting.  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.
Headache, fever, extremely cold, stiffness in body, arms and legs(especially right leg). Anxiety, Sleeplessness, Fatigue
I had a very bad sore throat with white spots on tonsils and white patches on the roof of my mouth and blisters on the back of my mouth. Was given penicillin for 10 days. Was feeling any better after taking the course so called dr again and gave me prednisone and benzonitate for cough. Still wasn?t any better had more symptoms of stuffy nose. I went to urgent care and gave me Clindmyicin for 10 days  and tested me for Covid. Covid test came back negative but gave the test that took 5 days to come back and had KHU1 Covid  and Haemopilus flu.  I was feeling better after the 10 day course of clindamyicin. So was sick for 3-4 weeks and worked every day with a mask on. Luckily no one else got sick from my work place.
101F fever, chills, headache, louder than usual tinnitus, muscle aches, 8 cm diameter swelling, redness, soreness at injection site. Most symptoms abated after 24 hours; injection site swelling and redness lasted three days.
Marked generalized lymphadenopathy - started with marked local lymphadenopathy in left, supraclavicular lymph node cluster 10 days post vaccination - went to ER and had CT scan which showed marked enlargement. Saw ENT 12 days post vaccination - prescribed 4 day course of prednisolone, which did NOT result in decrease in size of lymph nodes. Generalized lymphadenopathy followed around 5 days later with several lymphnodes palapable all over my body, included by not limited to occipital, inguinal, superficial cervical and submandibular. Pattern of enlargement was asymmetrical. Lymphnodes returned to normal after approximately 4-5 weeks.  On April 1st I experienced a full body rash from my neck to my toes. Small, stipulated, erythematous spots appeared all over my body. It was painful and felt like a sunburn. This rash lasted for 3 days and dissipated eventually.  I took Benadryl twice per day to treat rash.
Received nasal vaccine in clinic.  Previously received injectable vaccine without any reaction.  6 days later, c/o sudden onset facial swelling.  PE showed soft tissue swelling mid-forehead extending down to bridge of nose, no uvular edema or tongue swelling.  Head CT unremarkable.  Rxed with methylpred, diphenhydramine & famotidine with good response.  Discharged home on prednisone & diphenhydramine.
sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In August 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (sore arm). At the time of the report, VACCINATION SITE PAIN (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications was provided.  No Treatment medications was provided.   Reporter did not allow further contact
Woke up next day (around 7am) with a severe headache, nauseous, and light-headed to the point of feeling like going to pass out.  Slept most of the day.  Side effects subsided slowly by the evening (around 6pm) but did not feel truly mostly normal until the following dat.  By third day, felt normal enough to go back to school.  Did complain about stomach cramping that third morning but unclear if related.
This spontaneous report as received from a other health professional regarding an unspecified number of patients of unknown age. There was no information about concurrent condition and historical medication. On an unknown date the patients were vaccinated with improperly stored LIQUID PEDVAXHIB, lot # I002867, expiration date 11-NOV-2017 (dose strength was unknown). No concomitant medication was reported. No adverse event was reported. No PQC (product quality complaint) was involved. The outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Client here today for immunizations. Client received VZV, HAP, MCV after vaccine admin. Approx. 10:30 am. client c/o upset stomach, cold compress admin to head. Client placed head between legs. BP 100/70, pulse 80. After 5 min client states she is okay while texting on phone. Incident reported to supervisor on duty.
Rash on right eye; Reddish eye; Rash on the neck; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of EYELID RASH (Rash on right eye), OCULAR HYPERAEMIA (Reddish eye) and RASH (Rash on the neck) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced EYELID RASH (Rash on right eye), OCULAR HYPERAEMIA (Reddish eye) and RASH (Rash on the neck). The patient was treated with METHYLPREDNISOLONE for Eyelid rash, Ocular hyperemia and Neck rash, at an unspecified dose and frequency. At the time of the report, EYELID RASH (Rash on right eye), OCULAR HYPERAEMIA (Reddish eye) and RASH (Rash on the neck) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: Follow up information received: NNI.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.