chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Myalgia, Fever, NauseaVomiting, lightheaded, fatigue, chills Narrative:  Low grade fever, body aches, chills, nausea, lightheadedness, headaches. Took Tylenol and Ibuprofen OTC. Arm remains sore today and still having a few headaches.
PATIENT PRESENTED FOR HER 2ND COVID VACCINE IN SERIES AND GOT MODERNA AS 1ST DOSE.   I INADVERTENTLY ADMINISTERED PFIZER AS HER 2ND DOSE.  DISCUSSED WITH PT THAT EFFICACY AND SIDE EFFECTS PROFILES ARE CLOSE TO THE SAME WITH THE 2 VACCINES.  SHE WAS NOT MAD OR CONCERNED.  WE RESOLVED THE INCIDENT AT THE STORE LEVEL
it's been 9 months instead of 6 months; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 1st June 2021).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 29-Mar-2022 Reporter's Comments: Pharmacist enquired that a patient had a Shingrix vaccine and it's been 9 months instead of 6 months and patient wanted their second vaccine in the series, so could he/she get it or patient had to restart the whole series. The reporter consented to follow up with health care professional via postal. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
1-2 seconds after immunizations administered child became unconscious and fell back on the exam bed. Her respirations were 22/sec HR was 88 BPM pulse strong, PERRLA, she regained consciousness in 20 seconds, cried, but did not remember fainting. Walked out of office well. No jerking noted.
pt recv vax JUN95 & approx 27NOV97 pt devel chickenpox;
patient received 0.25ml of dose; This spontaneous case was reported by a consumer and describes the occurrence of UNDERDOSE (patient received 0.25ml of dose) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced UNDERDOSE (patient received 0.25ml of dose). On 25-Mar-2021, UNDERDOSE (patient received 0.25ml of dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was provided.
shortness of breath, generalized weakness, loss of taste and smell, nauseated, diarrhea or abdominal pain   supplemental oxygen per hypoxia along with IV remdesivir and IV dexamethasone, Tessalon for the cough
confusion; did not feel right; Cellulitis; FACILITATED COLLECT  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4241744-00 (AbbVie).  A 54 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date Feb2021 (Batch/Lot number: unknown) at the age of 54 years as dose 2, single for covid-19 immunisation; risankizumab (SKYRIZI [RISANKIZUMAB]), subcutaneous since Sep2021 (ongoing) (Batch/Lot number: unknown) for psoriasis. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose:01, Route of Admin: Intra-muscular), administration date: Feb2021, when the patient was 54 years old, for COVID-19 Vaccination. The following information was reported: CONFUSIONAL STATE (hospitalization) with onset 2021, outcome "unknown", described as "confusion"; FEELING ABNORMAL (hospitalization) with onset 2021, outcome "unknown", described as "did not feel right"; CELLULITIS (medically significant) with onset 2021, outcome "unknown", described as "Cellulitis". The patient was hospitalized for confusional state, feeling abnormal (start date: Mar2021). The action taken for risankizumab was dosage not changed.  The reporter considered "cellulitis" related to bnt162b2. Reporter's causality assessment for events confusional state and feeling abnormal due to bnt162b2 was not provided. The reporters causality for the events and Skyrizi (Risankizumab) were not provided. AbbVies opinion is that there is a reasonable possibility that the event of cellulitis is related to Skyrizi (Risankizumab).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As per available information , the causal association between the reported event and the suspect drug cannot be excluded.
My left arm has had pain and numbness since the injection in November; My left arm has had pain and numbness since the injection in November; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40-year-old male patient received BNT162b2 (BNT162B2), on 13Nov2021 as dose 3 (booster), single (Lot number: FH2087) at the age of 40 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose Number: 2, Lot No: EN6208, Location of injection: Arm Left), administration date: 17Mar2021, when the patient was 40-year-old, for COVID-19 immunization; BNT162b2 (Dose Number: 1, Lot No: EN6200, Location of injection: Arm Left), administration date: 24Feb2021, when the patient was 39-year-old, for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (disability), HYPOAESTHESIA (disability) all with onset 13Nov2021, outcome "not recovered" and all described as "My left arm has had pain and numbness since the injection in November". The events "my left arm has had pain and numbness since the injection in november" required physician office visit. Therapeutic measures were taken as a result of pain in extremity, hypoaesthesia. Clinical Course:No other vaccine in four weeks. Patient reported that My left arm has had pain and numbness since the injection in November. I have tried different pain killers and physical therapy. Nothing has improved the symptoms. Any idea's?. if treatment ae Yes. ae treatment Cream/medicine/Physical Therapy. if covid prior vaccination was No. if covid tested post vaccination was No.
Tired; Sore; 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 FATIGUE (Tired) and MYALGIA (Sore) in a patient of an unknown age and gender 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 FATIGUE (Tired) and MYALGIA (Sore). At the time of the report, FATIGUE (Tired) and MYALGIA (Sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Treatment information was not provided. No concomitant medication was provided.
I got reddish; itch; This is a spontaneous report from a contactable consumer (patient) reported for himself/herself that. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6204, UPC, NDC number and Expiry date: Unknown), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Two weeks ago, the patient got Pfizer vaccine (further not clarified hence, captured as unspecified vaccine) first time and then after few days on an unspecified date, my body changed, I got reddish, I was itch for three weeks maybe, I am also itching. The patient was asking to get a second vaccine. The patient think it was a side effect because patient don't have any food allergy or medicine allergy. The patient went to the hospital to ask to Doctor, doctor told patient it's normal side effect over vaccine the patient not assure. The patient was worry, little bit worried and didn't get a fever. Outcome of the events was unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
After receiving 3 vaccines pt felt dizzy. Cool compress applied sucker given. Pt waited 15 min then left without incident.
Arm swelled up and "hasn't felt right since". Patient experienced redness, tenderness, pain and numbness in arm, and tingling in hand.
a sore left injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (a sore left injection site arm) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced VACCINATION SITE PAIN (a sore left injection site arm). At the time of the report, VACCINATION SITE PAIN (a sore left injection site arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant medications were not provided. Treatment information was not provided.
Itchiness, tingling around lower lip. Bilateral arm tingling and lightheadedness. BP 125/74, pulse 64; refused Benadryl.
3wk post vax weakness in upper/lower extremities-hosp;dx inflammation polyneuropathy;
10/14 normal soreness 10/16 approximately 7cm red, hot area for 2-3 days. Then small bumps with itching. Two small spots with itching still.
02/15/22 presents to ED for " Shortness of Breath, Chest Pain". PMHx of "CAD s/p PCI, CHF, HTN, TAVR (11/16/21), Afib on plavix"
developed rashes 2 days after/ The rashes worsened over time/ diagnosed him with molluscum; This spontaneous case was reported by an other caregiver and describes the occurrence of MOLLUSCUM CONTAGIOSUM (developed rashes 2 days after/ The rashes worsened over time/ diagnosed him with molluscum) in a 3-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 05-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Jul-2022, the patient experienced MOLLUSCUM CONTAGIOSUM (developed rashes 2 days after/ The rashes worsened over time/ diagnosed him with molluscum). At the time of the report, MOLLUSCUM CONTAGIOSUM (developed rashes 2 days after/ The rashes worsened over time/ diagnosed him with molluscum) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2022: Follow-up document received includes reporter details, additional reporter and patient's demographics.
Flu vaccine received Monday 1/14/13 - Patient states next day noticed tenderness in lymph node approx 1-2" below (R) axillary area. Had mammogram scheduled - technician noticed inflammation of node. Pt states tender to touch. No fever noted.
Initial report was received on 07 August 2014 from a health care professional. A 66 year-old male patient had received on 16 January 2014 an intramuscular left deltoid injection of FLUZONE (Sanofi Pasteur Inc. lot number UH918AA) and an unspecified amount of time later, developed an "infection" and was hospitalized for two months (dates not reported). According to the reporter, the patient was advised by another pharmacist that he had an infection. The patient went to the emergency room but the physician diagnosed no infection. The patient went to a different hospital and was hospitalized for two months for reason unknown to the reporter. The patient also claimed that he had limited use of his left arm and had received rehabilitation to gain full use of his left arm. Treatments were not reported. Illness at the time of vaccination was denied by patient. The patient had received unspecified flu vaccine in the past, manufacturer and date was not reported. The patient's other past medical history was unknown. No further information was available at the time of the report. Outcome was unknown. Documents held by sender: none.
her varicose veins started hurting; feels cold, her hands feel frozen; Lips are split; Mouth feels dry; very thirsty and even if she drinks water, it won't go away; hasn't been able to go to work for two days; diarrhea  mild; vomiting; headache that only today got tolerable; body ache; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of VARICOSE VEIN (her varicose veins started hurting), FEELING COLD (feels cold, her hands feel frozen), LIP INJURY (Lips are split), DRY MOUTH (Mouth feels dry) and THIRST (very thirsty and even if she drinks water, it won't go away) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 02032A and 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Palpitations (before the vaccines, she had an episode of palpitations), Swollen ankles (before the vaccines, left ankle got swollen) and Vein pain (before the vaccines , the veins hurted).   On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Apr-2021, the patient experienced FEELING COLD (feels cold, her hands feel frozen), LIP INJURY (Lips are split), DRY MOUTH (Mouth feels dry), THIRST (very thirsty and even if she drinks water, it won't go away), IMPAIRED WORK ABILITY (hasn't been able to go to work for two days), DIARRHOEA (diarrhea  mild), VOMITING (vomiting), HEADACHE (headache that only today got tolerable), MYALGIA (body ache) and FATIGUE (fatigue). On an unknown date, the patient experienced VARICOSE VEIN (her varicose veins started hurting). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VARICOSE VEIN (her varicose veins started hurting) had not resolved and FEELING COLD (feels cold, her hands feel frozen), LIP INJURY (Lips are split), DRY MOUTH (Mouth feels dry), THIRST (very thirsty and even if she drinks water, it won't go away), IMPAIRED WORK ABILITY (hasn't been able to go to work for two days), DIARRHOEA (diarrhea  mild), VOMITING (vomiting), HEADACHE (headache that only today got tolerable), MYALGIA (body ache) and FATIGUE (fatigue) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Medical observation: inconclusive (Inconclusive) Patient went to the hospital where the nurse practitioner did a vein exam  and told her she seemed fine..         No relevant concomitant medications were provided. The action taken for mRNA-1273 was not applicable.   This case was linked to MOD-2021-098160 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 31-May-2021: Follow-up information was received and  reporter information, laboratory information , a new event varicose vein, outcome of events were updated.
Got sick  on Christmas Day 25th- low grade fever/aches; diarrhea; went on to have shortness of breath and some runny nose and congestion and a lot of fatigue   27th. Went to urgent care -    was really tired; runny  nose and congestion; Covid test was positive. Regenerome - On the 30th.  Tylenol and Ibuprofen.
pt recv vax 930AM & family returned 1030AM w/child c/o pruritic lesions on neck trunk & arms;appeared to have urticaria (only known allergy is to beef & port, no allergy to eggs);only ate cookies & tea a/going home;t97.8, BP 92/58;
GARDASIL given by RN prior to MD going into see the patient. Mom open exam room door approx 5-10 min after injection stating patient passed out & was shaking. MD & RN went in - pt lying down with feet increased - applied cold compress. Pt stated she felt funny - his eyes rolled back, body shook & head jerked to (L) side - very pale.
Two series of Janssen COVID-19 Vaccine First series: COVID19(Janssen), Janssen, LOT 403A21A , Intramuscular, Arm side unknown 09/08/2021 Second series: COVID19(Janssen), Janssen, LOT 402A21A, Intramuscular, Left Deltoid 09/28/2021 One dose recommendation. Individual received two doses All vaccines administered on 09/20/2021 except for COVID19 Janssen  I believe the data on a database is incorrect for Janssen given on 09/28/2021  FYSA:  A group has been requested to enter all COVID vaccines into a database. The teams responsible for screening and administering vaccines to the refugees at a mass vaccination center.   Group is assisting with e
Patient states arm very red and swollen since injection. The site was hard but that has since decreased and area of redness appears larger. Patient used compresses and was going to take Benadryl in case she is having an allergic reaction.
Left arm posterior, upper immediate red, raised area on skin with hard knot-like area palpable in center of area. Given Benadryl (1mg 1kg) and monitored 1 our post vaccine. Will call tomorrow to check reaction site.
Local reaction, no signs of infection. May apply ice to help with swelling/ discomfort. Hydrocortisone PRN.
medication error with no adverse event; Initial information received on 25-Jan-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 15 months old female patient who had medication error with no adverse event while receiving vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 03-Jan-2022, the patient received a  dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot U7184AA via intramuscular route in unknown administration site.  On 03-JAN-2022 the patient had medication error with no adverse event (medication error) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (medication error with no adverse event).  At time of reporting, the outcome was Unknown for the event medication error with no adverse event.  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.
Irregular period. Missed 2 cycles. No menstrual cycle for 60 days.  Was supposed to start 1/24/21, and then start again on 2/19/21.  No treatment. Had cycle on 2/28/21. Continuing to have late, irregular cycles now. Previously had normal cycles, occurring every 26 days.
Rash began on day 5. itching and redness. whelts, no blisters.
ear splitting; Pfizer covid booster shot, the third dose; experienced their 6th day of a Migraine headache; life changing; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE-1, Primary Immunization series complete but unknown manufacturer), for Covid-19 immunization; Covid-19 vaccine (DOSE-2, Primary Immunization series complete but unknown manufacturer), for Covid-19 immunization. The following information was reported: EAR DISORDER (medically significant), outcome "unknown", described as "ear splitting"; IMMUNISATION (non-serious), outcome "unknown", described as "Pfizer covid booster shot, the third dose"; MIGRAINE (non-serious), outcome "unknown", described as "experienced their 6th day of a Migraine headache"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious), outcome "unknown", described as "life changing". Clinical course: The patient called about the Pfizer covid booster shot, the third dose and reported that he received his Pfizer Covid-19 Booster Vaccine with his 60-year-old mother and they both have experienced their 6th day of a migraine headache. The patient asked had this been reported, how long will it last, missing work, was Pfizer going to shoot him a check from their big deal with country, did not get the Booster, it did not work against Omicron. The patient asked was it normal for people to experience ear splitting, life changing, migraines 4-5 days after getting the shot.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
3 days p/vax required ER visit to hives, rash, lips swelling;
Branch Retinal Artery Occlusion.  Partial Loss of eyesight. In right eye.
Lightheadedness & ringing in ears. BP 95/60; HR 89; RR 16. Pt AOx4; VS stable; pt escorted home with mother
3RD DOSE PFIZER COVID VACCINE GIVEN 11/10/21, #FF2587; 9/7/22 pt to hospital with a sudden onset of aphasia and rightward gaze; found to have acute right frontal lobe IPH and right ventricle IVHJ with mass effect, right-left midline shift; also found to be positive for COVID; family transitioned pt to comfort measures and GIP hospice where pt passed away
Visible angioedema of the lips and ears. Complaints of throat swelling. MD on site called, consulted, EMS activated. Epi 0.3ml administered at right outer though. Swelling improved after 5-10 minutes. Stable VS. Transferred to hospital via ambulance.