chrisvoncsefalvay/vaers-outcomes huggingface dataset:
expired MENACTRA was administered to a 66 year old post-splenectomy patient (with no reported adverse event); off-label use as per local labelling due to administering MENACTRA to a patient who is 66 years old and outside of the approved age group (with no reported adverse event); Initial information received on 28-Apr-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 66 years old female patient to whom expired meningococcal A-C-Y-W135 (D CONJ) vaccine [Menactra]. was administered post-splenectomy (with no reported adverse event) and off-label use as per local labelling due to administering menactra to a patient who is 66 years old and outside of the approved age group (with no reported adverse event)   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 28-Apr-2022, the patient received 0.5 mL Dose (if series -2) of suspect meningococcal A-C-Y-W135 (D CONJ) vaccine [Menactra] lot U6920AA, expiry date: 15-Apr-2022 (strength and formulation not reported) via intramuscular route in the left deltoid for Prophylactic vaccination.  Practice manager stated that they administered an expired dose of MENACTRA to a patient (expired product administered) on 28-Apr-2022, latency same day. Practice manager asked how they should proceed and if they would need to re-administer the dose? Practice manager also mentioned that the expired MENACTRA was administered to a 66-year-old post-splenectomy patient. This situation was reported as a medication error due to administering expired MENACTRA to a patient. This situation was reported as an off-label use as per local labelling due to administering MENACTRA to a patient who was 66 years old and outside of the approved age group (product administered to patient of inappropriate age) (onset date 28-Apr-2022, latency same day).   First time product used : No  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for both the events.  At time of reporting, the outcome was Unknown for both the events   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.
Patient came into pharmacy and showed me her right arm where she received PNEUMOVAX and FLUVIRIN shots. It was red and blotchy from her shoulder to her elbow.
I did not have any reaction at the Health Department with either dose.  However, a few hours after the 1st dose vaccine, I noticed a slight puffiness around my mouth, but it didn't last long and subsided -- frankly, I forgot about it.  Approximately 50 minutes after the 2nd dose vaccine, the area around my mouth, chin, and lower part of both cheeks felt puffy and had some numbness (similar to the feeling after getting a numbing shot at the dentist -- that type of feeling of puffiness and slight numbness.)  It lasted about an hour before completely subsiding.  I did not take anything for this or seek medical attention.
Severe arm pain and nausea; Patient called ambulance to pick her up to take her to ER; Hospital prescribed Hydrocodone/APAP for pain and Zofran for nausea.
This spontaneous report was received from a medical assistant regarding an unspecified number of patients of unknown demographics. There was information about concurrent condition and historical medication. On an unknown date the patient were vaccinated with improperly stored GARDASIL 9 lot # L020015/Expiration Date- 16-AUG-2017, lot # L044475/Expiration Date- 12-MAY-2017, lot # M013636/Expiration Date- 15-FEB-2018, lot # L043214/Expiration Date- 30-AUG-2017, lot # M018810/Expiration Date- 28-MAY-2018. No adverse event was reported. No concomitant medication was reported. The outcome of the event was unknown. No PQC was involved. This is one of several reports received from the same reporter. Additional information has been requested.
started to become red again; injection had site reaction, a little itchy; grew to size half dollar, swollen; warm; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE PRURITUS (injection had site reaction, a little itchy), VACCINATION SITE SWELLING (grew to size half dollar, swollen), VACCINATION SITE WARMTH (warm) and VACCINATION SITE ERYTHEMA (started to become red again) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026LL20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (injection had site reaction, a little itchy), VACCINATION SITE SWELLING (grew to size half dollar, swollen) and VACCINATION SITE WARMTH (warm). On 19-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (started to become red again). At the time of the report, VACCINATION SITE PRURITUS (injection had site reaction, a little itchy), VACCINATION SITE SWELLING (grew to size half dollar, swollen), VACCINATION SITE WARMTH (warm) and VACCINATION SITE ERYTHEMA (started to become red again) had resolved.        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 drugs provided. No treatment.
Initial information received on 05-Mar-2019 regarding an unsolicited valid non-serious case received from Other health care professional (Medical Assistant). This case involves a 11 years old male patient who received vaccine MENACTRA. The patients past medical history and family history were not provided. Concomitant medications included on 04-Mar-2019-ADACEL and HPV Vaccine. On 04-Mar-2019, the patient received a 0.5ml first dose of suspect Meningococcal A-C-Y-W135 (D Conj) Vaccine, lot U5833AA, expiry date 25-Feb-2019 via intramuscular route in the left deltoid. It was a case of actual medication error due to expired vaccine used. It was reported that 11 years child was given an expired MENACTRA (expiry date 25-Feb-2019) on 04-Mar-2019. It was unknown whether patient experienced any adverse reaction after the injection. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.
Tenderness on the injection Site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Tenderness on the injection Site) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, the patient experienced VACCINATION SITE PAIN (Tenderness on the injection Site). On 29-Apr-2021, VACCINATION SITE PAIN (Tenderness on the injection Site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was given. No laboratory details was given. No treatment information was given. The Second dose is scheduled for 27MAY2021 at 2:40PM.
developed weakness and myalgias  10/17/2021. admitted to Hospital and died on 10/20/2021
Adverse event: Hives, redness, and itching on face, neck, chest,  bilateral arms, abdomen, back, bilateral side of the groin, Bilateral legs front and back, and both tops of the feet   Treatment: Bendrayl PO, 50 mg Q4 hrs, Prednisone PO 40 mg Daily, Pepcid PO 40 mg Daily.   Cortisone 1% cream and Calamine lotion on affected areas  Outcome: Effective, 90% of rash gone.
Client lost consciousness for about 1 minute in chair and was assisted to floor.  Client's mother was unconcerned and states that she has done this previously with shots/ medical procedures.
Received vaccine at 0900 on 29 April. Felt slightly tired and my left arm was sore around 2100. Woke up at 0500 on 30 April with a severely swollen tongue covered in red spots and sores. No other symptoms. Went to the health clinic for assessment. As my lips/throat were not swollen and vitals were normal, I was just given an antihistamine and told to monitor my symptoms.
2 - 5 minutes after receiving the shot, while in the observation area, I experienced dizziness, rapid heart beat, and warm flush that lasted several minutes.  After the first shot in January I became faint but this time, it did not progress that far, and I was able to control it with deep breathing etc.  The staff were on hand to assist as they were made aware of my reaction to the first shot.  I didn't need nurse assistance this time, and experienced normal side effects for the next few days (fatigue, nausea, pain at injection site, etc).
Patient was given an expired vaccine. Patient did not have any symptoms or reactions within the 15 minutes of the vaccine.
Case PHEH2016US028929 is an initial spontaneous report received from nurse on 02 Nov 2016. This report refers to 65 year old female patient. Medical history and concomitant medication was not reported. The patient was vaccinated with FLUVIRIN (batch number: 1619221) 0.5 ml in left deltoid on 13 Sep 2016. On an unspecified date, the patient experienced temperature excursion prior administration (minus 2.7 Celsius for 6 hours and 4 minutes minus 3.6 Celsius for 21 hours and 48 minutes minus 3.4 Celsius for 21 hours and 2 minutes minus 3.3 Celsius for 21 hours and 3 minutes minus 3.3 Celsius for 8 hours and 4 minutes 1.2 Celsius for 1 hour and 1 minute 1.7 Celsius for 1 hour and 5 minutes was not frozen). The patient had been notified will be revaccinated. No adverse event was reported following this medication error. The case was assessed as non serious by the nurse.
This spontaneous report was received from a registered nurse referring to multiple, unspecified number of patients of unknown age and gender. Pertinent medical history, concurrent conditions and drug reactions/allergies were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of ROTATEQ, orally, lot # K011952 with expiration date 17-JUN-2016, (dose was not provided). Concomitant medication was not reported. No adverse effects were reported. This is one of the several reports received from the same source. Additional information has been requested.
I had an ablation of my uterus 2 -3 years ago and have not had periods; This is a spontaneous report from a contactable consumer (patient) reporting on herself. A 44-year-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: 3248), via an unspecified route of administration, administered in Arm Left on 23Mar2021 10:15 (At the age of 44-year-old) as single dose for COVID-19 immunization. Medical history included , endometrial ablation, amenorrhoea, inter menstrual bleeding (I had an ablation of my uterus 2 -3 years ago and have not had periods or have had very little spotting) from an unknown date. There were no concomitant medications. The patient had no known allergies. The patient had not tested covid prior to vaccination and post vaccination. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, (Batch/Lot Number was unknown) as single dose for COVID-19 immunization. The patient experienced had an ablation of my uterus 2 -3 years ago and have not had periods or have had very little spotting. following the second dose and on my cycle, my period is very, very heavy like before had an ablation on 18Apr2021 10:00. The outcome of event was unknown.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021325918 Same patient, same drug, different event (split)
45minutes to an hour after the vaccine I went into SVT. I went to the emergency room and got adenosine.  Don?t know if this was a reaction or coincidence. I waited the 15 minutes and walk Ed to my car and went into SVT.
Flu vaccine was administered in the morning on an empty stomach and patient passed out, called EMT services and primary MD was informed about the incident.
This is a spontaneous report from a contactable pharmacist.   A female patient of an unspecified age and ethnicity received  PREVNAR 13 (Lot # M06899, Expiry Date Mar2017), via an unspecified route of administration  at 0.5 ml, single on 11Oct2016 for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced broke out into rash at injection site on 17Oct2016 with outcome of unknown.
Covered their throats, they lose their breath; Dizzy; Body aches; Headahe; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Covered their throats, they lose their breath), DIZZINESS (Dizzy), MYALGIA (Body aches) and HEADACHE (Headahe) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004c214) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, the patient experienced DYSPNOEA (Covered their throats, they lose their breath), DIZZINESS (Dizzy), MYALGIA (Body aches) and HEADACHE (Headahe). The patient was treated with PARACETAMOL, PHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE (THERAFLU [PARACETAMOL;PHENIRAMINE MALEATE;PHENYLEPHRINE HYDROCHLORIDE]) at an unspecified dose and frequency; IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency; PARACETAMOL (TYLENOL) at an unspecified dose and frequency and ASCORBIC ACID (VITAMINE C) at an unspecified dose and frequency. At the time of the report, DYSPNOEA (Covered their throats, they lose their breath), DIZZINESS (Dizzy), MYALGIA (Body aches) and HEADACHE (Headahe) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported.   This case was linked to MOD-2021-103027 (Patient Link).
Body Aches; sore arm at the injection site; tiredness; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Body Aches), VACCINATION SITE PAIN (sore arm at the injection site) and FATIGUE (tiredness) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031B21A and 030A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Apr-2021, the patient experienced MYALGIA (Body Aches). 03-Apr-2021, the patient experienced VACCINATION SITE PAIN (sore arm at the injection site) and FATIGUE (tiredness). At the time of the report, MYALGIA (Body Aches), VACCINATION SITE PAIN (sore arm at the injection site) and FATIGUE (tiredness) outcome was unknown. Not Provided          Concomitant Medications were not provided by the reporter. Treatment Medications were not provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2021-069670 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-069670:
Ongoing Condition getting progressively worse. Body weakness, lethargic, severe muscle spasms and tightening, severe pain in extremities, slurred speech, loss of cognitive skills and short term memory, unable to walk at times and care for self or my children.
Nausea; Muscle pain; Headache; Pain from "head to toe,"; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NAUSEA (non-serious), outcome "unknown", described as "Nausea"; MYALGIA (non-serious), outcome "unknown", described as "Muscle pain"; HEADACHE (non-serious), outcome "unknown", described as "Headache"; PAIN (non-serious), outcome "unknown", described as "Pain from "head to toe,"".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
facial twitching; I spent that winter sicker than I had ever been; Initial information received on 25-Oct-2021 regarding an unsolicited valid social media non-serious case received from a consumer or non-healthcare professional via Digital Media.  This case involves adult patient (unknown gender) who experienced facial twitching (muscle twitching) and patient spent that winter sicker than had ever been (illness) after receiving INFLUENZA VACCINE.  The patient had no medical history, concomitant disease or risk factor.   The patient medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number and expiry date not reported] via unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious facial twitching (muscle twitching), spent that winter sicker than had ever been (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported  "I only got flu shot 3 times in my life. The last one caused facial twitching which lasted for many months and I spent that winter sicker than I had ever been. My own doctor attributed it to the shot. Said was rarest thing the patient ever seen. So dear didn't play doctor and encourage someone what to do. You didn't know their story."  It was unknown if the patient experienced any additional symptoms/events.  There were no lab data/results available.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was unknown for the reported event.  There will be no information available on the batch number for this case.
Arm is very sore from the injection; Has terrible chills; Headache; Muscle pains; A lot of fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm is very sore from the injection), CHILLS (Has terrible chills), HEADACHE (Headache), MYALGIA (Muscle pains) and FATIGUE (A lot of fatigue) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Nov-2021, the patient experienced PAIN IN EXTREMITY (Arm is very sore from the injection), CHILLS (Has terrible chills), HEADACHE (Headache), MYALGIA (Muscle pains) and FATIGUE (A lot of fatigue). At the time of the report, PAIN IN EXTREMITY (Arm is very sore from the injection), CHILLS (Has terrible chills), HEADACHE (Headache), MYALGIA (Muscle pains) and FATIGUE (A lot of fatigue) outcome was unknown.            No concomitant medication was provided by the reporter.  No treatment information was provided by the reporter.
First dose of Moderna vaccine, Pain in arm at first Red, itchy area around the vaccine injection after one week or so.
8/20/14 Mom states child limping on right leg-that hip was pulled out of socket somehow when we were holding for vaccines. 8/25/14 Mom phoned again - says xray of knee negative. Child better and walking around. Took Ibuprofen for inflammation.
Patient said her knee got inflamed and went to her doctor and doctor said it was probably related to the Flu shot.
Diarrhea, pneumonia - SOB. Admitted. Weakness- 10/25 @ 0451: Pt c/o worsening weakness. He is unable to sit himself up this morning. He denies difficulty breathing. He is unable to close his fist or stand or sit up independently. Progressive motor weakness, concerning for Guillain Barre syndrome. Transferred to medical center, Dr. accepting (neurology) 10/25 @ 1206.
pt recv vax 17JUN97 & w/in 24hr pt presented s/s of itching, redness & a 10mm induration @ inj site;pt applied over the counter hydrocortisone ointment but sx still persisted;
a clot; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (a clot) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (a clot) (seriousness criterion medically significant). At the time of the report, THROMBOSIS (a clot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication provided. No treatment information mentioned. Company Comment :Very limited information regarding this event has been provided at this time. However, based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information can't be requested.   Reporter did not allow further contact; Sender's Comments: Very limited information regarding this event has been provided at this time. However, based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information can't be requested.
Left arm became numb with electric shocks running down to my hand. Middle, ring and pinkie fingers folded down into the palm of my hand and would not open up. I could not use my hand which made it extremely difficult as I am left-handed. It has been two months and I still cannot use my hand. My fingers have opened up a bit and will not completely open up. I still have no strength in the hand. I have been going to physical therapy since November 3, 2018.
Swelling throat; BP 120/74, pulse 74, O2 sat 99%. Benadryl 25 mg PO given, then Benadryl 50 mg IM. Patient stabilized.
Severe headache, body ache, fever, nausea, chills, vomiting.