chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; Got the Bivalent vaccine before they got the primary series; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Got the Bivalent vaccine before they got the primary series) and NO ADVERSE EVENT (No adverse event) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) 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)) (unknown route) 1 dosage form. In October 2022, the patient experienced WRONG PRODUCT ADMINISTERED (Got the Bivalent vaccine before they got the primary series). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Got the Bivalent vaccine before they got the primary series) 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)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Got the Bivalent vaccine before they got the primary series). The patient was an adult man in his early 30s. Concomitant product use was not provided by the reporter. It was reported that the patient got the Bivalent vaccine before they got the primary series sometime last week but they did not know the specific date.  Treatment information was not provided.   Reporter did not allow further contact
pt recv vax; 10 days later devel fever 102-103; day 11, got rash; T persisted 101-103 x 4 days; seen by MD 11jul95;
This spontaneous report was received from a medical assistant via office manager and refers to patient of unknown age and gender. On 26-AUG-2014 the patient was vaccinated with LIQUID PEDVAXHIB, (lot # K000331, expiry 23-OCT-2016, dose, dose # and route unspecified), that was exposed to temperatures outside of the proper storage range on unspecified dates. No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Large, red, extremely painful sores on roof of mouth; Swollen glands in neck; Swollen tongue; Headache (intense pressure at back of head & in both temples); Fatigue; Continuous from one day after injection and for next 11 days.  However, as of today (11th day after injection), sores on roof of mouth are smaller and less red, but still very painful, making it difficult to eat.  Swollen neck glands & swollen tongue have diminished as of 11th day, but headache is still constant and I continue to be very fatigued.
J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 4/1/2023 OPERATIVE WOUND DEHISCENCE, INIT R09.02 HYPOXIA 3/31/2023 OPERATIVE WOUND DEHISCENCE, INIT J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 4/1/2023 ABDOMINAL PAIN R09.02 HYPOXIA 3/31/2023 ABDOMINAL PAIN J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 4/1/2023 PREEXISTING ESSENTIAL HTN IN PREGNANCY, THIRD TRIMESTER R09.02 HYPOXIA 3/31/2023 PREEXISTING ESSENTIAL HTN IN PREGNANCY, THIRD TRIMESTER J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 4/1/2023 SEVERE PERSISTENT ASTHMA R09.02 HYPOXIA 3/31/2023 SEVERE PERSISTENT ASTHMA
Rash to vaccinated left arm- mild- below vaccination site to elbow, and SOB Vitals:  B/P: 156/82, HR: 60, Resp: 12 02Sat: 99, Skin signs: Cool, dry. Denies itching c/o cold fingers, Circulation: Cap refill <2 sec, Resp.: Breathing sounds clear bilaterally. Treatment: observed for 30 mins and assess breathing 30 mins. Reassessment: 13:00 Vitals: B/P: 138/88, HR:60 Resp.: 12, O2Sat: 98, Treatment; Rash is lighter but still present denies SOB c/o left shoulder aching. Moved from triage to observation area to be observed by Dr. for 30 mins. Walked to restroom a steady. denies dizziness and SOB. Gave patient bottled water. Discharged home by self
10 Jan 10- pt noted onset of left sided facial weakness. Seen 12 Jan and diagnosed as having Bell's palsy. Dx with URI on 11 Dec 09.
Painful cold sore on upper lip, right side.  Tingling, throbbing open sore. lasted 10 - 14 days.  Took two tablets from pharmacy on one day.  Can't remember the name of it.  Also used Abreva cream daily.
Patient is a 91-year-old female with history of CHF and last ejection fraction 3 years ago was 41%, atrial fibrillation on Coumadin With her daughter/caregiver presenting to the emergency departmentfor shortness of breath.  Patient had a televisit with Dr. today who is covering for Dr., and noticed patient to appear short of breath and recommended she go to the emergency department.  Daughter at bedside states yesterday patient was outside in the cold, and she is afraid she developed pneumonia.  She also notes she has had diarrhea over the past couple of days, and patient stated she was nauseous last night.  She also has had a decreased appetite over the past 3 days, daughter states all she had was a piece of toast yesterday.  She did receive the Johnson & Johnson Covid vaccine. Associated Symptoms: appetite changes, bruise easily, cough, diarrhea, fatigue, nausea, shortness of breath
Chills, nausea, fever, joint aches, muscle aches, headache, and fatigue all within 24 hours; 48 hours later, a rash on the elbow of the arm where the vaccine was received.
Redness and soreness at injection site; Soreness at injection site; This spontaneous case was reported by an other caregiver and describes the occurrence of VACCINATION SITE ERYTHEMA (Redness and soreness at injection site) and VACCINATION SITE PAIN (Soreness at injection site) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A and 014B21A) for COVID-19 vaccination.     Concurrent medical conditions included Alzheimer's disease.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness and soreness at injection site) and VACCINATION SITE PAIN (Soreness at injection site). At the time of the report, VACCINATION SITE ERYTHEMA (Redness and soreness at injection site) and VACCINATION SITE PAIN (Soreness at injection site) outcome was unknown.        Products known to have been used by the patient, within two weeks prior to the event, included blood thinners  Treatment for the event included paracetamol.  The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event is not applicable.   This case was linked to MOD-2021-071383, MOD-2021-070988, MOD-2021-071416, MOD-2021-077195, MOD-2021-070997 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Patient developed symptomatic infection on 10/10 and tested positive for covid on 10/17/21.  Symptoms include loss of smell or tast, nausea, vomiting, diarrhea. SOB, fatigue, cough.  Patient's husband also sick with covid-19.
Patient experiencing raised, swollen rash below injection site on left arm.  Patient states hot to touch and is uncomfortable. Size of rash is about 3-4 inches in length.
Patient reports experiencing chills, fever of up to 104F, redness and swelling in the arm after receiving Fluad and Pneumovax. Patient was advised to take acetaminophen or ibuprofen for fever and Benadryl to help with swelling and redness in the arm. Patient reports symptoms lasted for 48 hours. Patient presented to pharmacy on 8/18 and swelling has subsided but still can see traces of some redness on the arm.
injection site soreness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old male patient received BNT162b2 (BNT162B2), on 17Mar2021 at 10:00 as dose 2, single (Lot number: EN6208) at the age of 66 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Skin cancer (basal squamous)", start date: 2017 (ongoing), notes: 2/3 previous outpatient surgeries 1 recent radiation treatment,finally 20th treatment on 25Aug2022; "Prostate cancer", start date: Nov2019, stop date: Jan2020, notes: Surgical removal Jan2020; "Cholesterol" (ongoing); "Acid reflux" (ongoing); "Surgical removal- Jan2020", start date: Jan2020 (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN oral taken for blood cholesterol abnormal (ongoing); OMEPRAZOLE oral taken for gastrooesophageal reflux disease (ongoing). Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot number: EN6198; Route of administration: Intramuscular; Anatomical Site: Left arm; Time of vaccination: 10:00AM), administration date: 24Feb2021, when the patient was 66-year-old, for Covid-19 immunization, reaction(s): "Injection site soreness". The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 2021, outcome "unknown", described as "injection site soreness".  Additional information: The patient started Atorvastatin 4 years ago and Omeprazole 3 years ago
It is Shingles; Slightly itchy; Small bumpy rashes; Tingling; Strange symptom; Weird sensation to my skin just the epidermis; Sore arm; Extreme fatigue; A spontaneous report was received from a healthcare professional concerning a 52-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events strange symptom/symptom masked, weird sensation to skin just the epidermis/feeling abnormal, small rash(small clusters, small bumpy rashes)/rash, slightly itchy/pruritus, sore arm/pain in extremity, extreme fatigue/ fatigue, tingling/paraesthesia and shingles/herpes zoster.  The patient's medical history was not provided. Concomitant medications reported were Vitamin D NOS.  On 15 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 025L20A) via unknown route in the left upper arm for prophylaxis of COVID-19 infection.  On 15 Jan 2021, the patient experienced the events, sore arm and extreme fatigue. On 06 Feb 2021, the patient experienced the events, strange symptom, weird sensation on skin just the epidermis just around my right hip, small rash went from the pelvic to all the way around the hip area. On 8 Feb 2021, the patient experienced the events, small clusters, small bumpy rashes that are slightly itchy, tingling, her doctor thought the symptoms might be of shingles brought by the vaccine. No treatment details were included.  Action taken with mRNA-1273 in response to the events was not reported.   At the time of this report, the outcome of events, strange symptom, weird sensation to skin just the epidermis, small rash, small clusters, small bumpy rashes, slightly itchy, sore arm, extreme fatigue, tingling and shingles were unknown.; Sender's Comments: Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. Fatigue and rash are consistent with the product known safety profile. Some vaccines have been known to exacerbate latent herpes zoster. Patient has a history of shingles
Metallic taste, eyes watering, feeling jittery, eyes itching, needs to take deep breathe
TOOK THIRD DOSE ON DAY 6; This spontaneous case (PVX2019-1636) was received from a pharmacist on 24-Jun-2019. It describes a 13-year-old adolescent male consumer who "took third dose on day 6" while being on Vivotif for an unknown indication.  Case report: The consumer took the third dose of Vivotif on day 6. The doses were taken on 18-Jun-2019, 20-Jun-2019, and 23-Jun-2019, respectively.  Action taken with Vivotif was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "took third dose on day 6" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took third dose on day 6" was considered as not applicable.
Vaccine given 11/1/06.  Fever, chills, dizziness developed that day, lasting until 11/6/06.
Diagnosed with Covid-19 on 03/01/2021. Admitted to hospital ICU on 03/01/2021. Presented with dyspnea, fatigue, shortness of breath. Patient had skipped dialysis treatments for an unknown amount of days. DIscharged from hospital on 03/04/2021. Total number of days: 4. Treated with Vitamin C, Vitamin E, Vit D, zithromax 500mg daily x 7 days; Zinc 50mg; dexamethasone 4mg x 10 days; Tussin DM; acetaminophen 500mg as needed. Currently in isolation for 21 days (03/01/2021 to 03/22/2021). Pt reported Symptoms resolved on 03/04/2021. Continues with Dialysis although schedule days have temporarily changed to Tuesday, Thursday and Saturdays until cleared from Covid-19.
Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in an 80-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 13-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.  Company comment- This case concerns an 80 year old patient, unknown gender, with no known medical history, who experienced the non-serious event of expired product administered. The event occurred  on the same day after third dose of mRNA 1273 vaccine. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.; Sender's Comments: This case concerns an 80 year old patient, unknown gender, with no known medical history, who experienced the non-serious event of expired product administered. The event occurred  on the same day after third dose of mRNA 1273 vaccine. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report
Developed an allergic response to nuts. I have never had a nut allergy in my life prior to this
Patient's boyfriend reports that patient experienced excessive menstrual bleeding for the2 days following administration of the vaccine
Pt called 10/27/15 and complained of severe muscle pain. His arm could not lift. Severe GI s/e. Pain level very high.
Client states she, "isn't good with shots" during administration. States she is feeling normal after vaccine is given. She leaves vaccine room and goes to lobby. Minutes later, client is on the ground in waiting room after having apparently fallen. Moved client to vaccine room. She has struck her left eyebrow on internal window sill and is bleeding slightly. The area is also swollen. Laid down, vitals taken, wounded area cleaned and iced. BP 108/75, pulse 60 at 1339. Called 911 for evaluation. EMS arrives minutes later and evaluates. Client denies EMS transport and elects to rest in vaccine room and then drive self home.
Sore arm; Fatigue; Dizziness; I also got some coughing like some phlegm and some congestion; I also got some coughing like some phlegm and some congestion; some congestion; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 09Nov2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Sore arm"; FATIGUE (non-serious) with onset Nov2021, outcome "unknown", described as "Fatigue"; DIZZINESS (non-serious) with onset Nov2021, outcome "unknown", described as "Dizziness"; COUGH (non-serious), PRODUCTIVE COUGH (non-serious) all with onset Nov2021, outcome "unknown" and all described as "I also got some coughing like some phlegm and some congestion"; NASAL CONGESTION (non-serious) with onset Nov2021, outcome "unknown", described as "some congestion".  Additional information: This is a spontaneous report from a non-contactable consumer. This non-contactable consumer (patient) reported for self that: patient mean that night patient had the sore arm and fatigue, some dizziness but patient also some congestion and patient was worried like they have given me a flu shot by mistake."  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
received her booster shot; received her booster shot; arm soreness; feeling exceptionally tired; This is a spontaneous report from a contactable consumer (Patient) or other non-HCP, who reported for his wife. A female patient of an unspecified age received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 07Oct2021, as DOSE 3, SINGLE dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Previously, the patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date, as DOSE 2, SINGLE and received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date, as DOSE 1, SINGLE for COVID-19 immunization. On 07Oct2021, the patient experienced who was a nurse received her booster shot that morning was reporting arm soreness and feeling exceptionally tired. No other symptoms. The clinical outcome of events was unknown.  The lot number for [BNT162B2], was not provided and will be requested during follow up.
A report received from a health care professional on 10/26/2002, concerning 12 vaccinees of unknown demography who inadvertently received an accidental overdose (1ml) of the Fluvirin vaccine on either 10/25/2002 or 10/26/2002. There were no adverse reactions at the time of the report. There was insufficient information to determine the reporters causality assessment.
Information has been received from a pharmacist concerning a 68 year old male with chronic obstructive pulmonary disease currently requiring hospitalization who on 7/24/03 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent. On 7/26/03, two days after the vaccination, the patient was found to also have developed a low grade fever. On 8/7/03, it was reported that the fever had been somewhat responsive to acetaminophen, but had also continued to the present. No other information was available. No product quality complaint was involved. Additional information has been requested.
pt devel localized rxn (knot @ inj site) approx 2 days p/vax;no fever or other rxn noted;pt doesn't appear to be uncomfortable (reporter's office spoke to mom on the phone & haven't seen pt;
Myalgia and arthralgia which started within 24 hours. Treated with Prednisone and ibuprofen.
SORE ARM; SEVERE FATIGUE/FATIGUE; HEADACHE; This spontaneous report received from a consumer concerned an elderly male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced sore arm, severe fatigue/fatigue, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe fatigue/fatigue, and headache, and the outcome of sore arm was not reported. This report was non-serious. This case, from the same reporter is linked to 20211110204.
Received ZOSTAVAX 9/12/12. Seen again in office 9/21 c/o itchy rash (vesicular) on arms, abdomen and fingers. No fever. Treatment was to monitor. Returns on 9/27/12 with Varicella like rash on abd, arms, legs. Treated with BENADRYL and TIAMVIR.
Father called stating left leg is swollen and red.  Instructed to put a cold washcloth on the area to get the heat out of it.  Swelling can last up to 7 days.
Swelling & Firm mass 1-2 weeks S\p injections  .Also ithing on body
Patient came in on 11/20/14 to ask if "pain near the inject site is normally after 1 month?". Patient states he has pain where BOOSTRIX was given. The pain is the size of a dime. Pain ranges from zero to seven on a 10 scale. On his right arm deltoid. Patient also states he's right handed and he's been more physical with a home remodel and outdoor chores. Referred patient to MD 11/22/14. I called pt today 11/24/14. Patient states he has not contacted MD. Pain is better.
About 4 to 5 weeks after the shot. Places where I had gotten cosmetic fillers began to swell on my face. My cheeks, my forehead meets my nose and around my mouth. It was hard and swollen, hot and very painful. I went to my PCP the next day. She advised me to use Benadryl and Ice and I did this for three days, and it came down and went away. My doctor stated this was inflammation reaction. I had a second episode maybe a month after that, I knew what it was so I took the Benadryl and Ice again and  it went down even faster.  I feel when the vaccine is working it reacts to my fillers.
Significant myalgia and severe chills (rigors) and mild flu like symptoms (weakness, headache, nausea, muscle pains, fatigue).
Patient had first Gardisil injection at her pediatric clinic without complications approximately 1 year ago.  Gave 2nd Gardisil 0.5ml injection in L Deltoid on 8/7/09.  Patient stated that it hurt then started to lean to the left side.  Her body went rigid, hands clenched at chin level.  She quickly sat up and opened eyes and became responsive.  She was pale, diaphoretic, radial pulse of 58 bp 90/60.  Placed her head between knees and did slow deep breathing.  Patient stated she felt better. VS more stable...pulse 64, bp 96/62.  Aproximately 10 minutes later, patient became pale, diaphoretic, dizzy c/o neck pain.  Radial pulse 58, thready, bp 92/58.  Staff called 911.  Kept patients head down, slow breathing until EMT's arrived.  Gave EMT's report of sx and vitals.  Patient vomited x 2.  Patient recovered.  EMT's stated that she vasovagaled from the injection.  She had not eaten dinner the night before or breakfast or had anything to drink since the night before which may have contributed to the fainting as well.  Patient did not want to go to ER...father signed release, patient left with dad and boyfriend.
Narrative:  MC, Moderna x4, outside covid test positive at nursing home. No covid symptoms. high potassium, blocked NG tube. GI bleed, on Eliquis, dark and blood stools. GI consult
got pfizer shot for 2nd dose, ptbecame aware and got the Moderna shot too
Hair loss-probable telogen effluvium possible alopecia areata 2 wks after FLUMIST.