chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Received faulty ancillary supplies. RN used 7 needles:                 1 was punctured through the cap, and I stuck my left thumb with it (clean stick)                 1 the cap didn?t come off                 2 worked as intended                 1 the needle bent while activating the safety feature post vaccination                 1 the needle broke while activating the safety feature post vaccination                 1 the safety feature wouldn?t activate post vaccination  Needle suuplied: Safety needle Manufactured by Yangzhou Medline Industry Lot: SN210108 Manufactured: 01/08/2021 Exp. date: 01/07/2026 25G, 1 1/2"
swelling in hands & legs assoc w/numbness 5 days post inj;resolved w/o sequale in 2mo;MD feels may have been viral in nature;
Patient in office for well child visit.  Given adult dose (1ML) of HEPATITIS A (HAVRIX) vaccine in error.  LMH staff notified.  CDC & poison control contact.  Per CDC & poison control, 0 adverse reaction expected.  Patient mother notified
Information has been received from a licensed visiting nurse concerning a 47 year old female with no pertinent medical history, penicillin and sulfonamide allergies and no other drug allergies, who on 17-OCT-2007 was vaccinated IM with a 0.5 ml PNEUMOVAX 23 (lot# 658555/0964U). There was no concomitant medication. On that same day the patient experienced an injection site reaction that was very itchy at the injection site. The patient was treated with BENADRYL. Also located at the injection site was a white spot with a red, swollen area about the size of 50 cent coin. The inflammation eventually spread from deltoid down to the elbow. The patient called the physician's office for medical attention. No labs or diagnostic studies were performed. The patient was not recovered at the time of reporting. A lot check was requested by the reporter. This is one of several reports from the same source. Additional information has been requested. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the government and was released.
Initial and follow-up information has been received from a pharmacist concerning a 54 year old male pharmacist who 21-NOV-2006, at 9:00 a.m., was vaccinated IM in the left arm with a second 0.5 ml dose of Pneumovax 23 (lot # 655669/1128F).  The same day, the patient was vaccinated in the same arm with a dose of influenza vaccine.  It was reported that the patient was vaccinated with a previous dose of Pneumovax 23 "one year ago."  Other concomitant therapy included losartan potassium (MSD), sulfasalazine and VOLTAREN.  On 21-NOV-2006, at 3:00 p.m., the patient's cheeks were flushed, his hands felt cold and he had trouble focusing on work.  Unspecified medical attention was sought.  On 22-NOV-2006, the patient recovered from the attention disturbance.  The outcome of the patient's flushing and peripheral coldness was unknown.  No additional information is expected.
10 days after the injection, I experienced an itchy rash at the injection site. It was a little over 1 inch in diameter. The injection site and surrounding area, over 2 inch in diameter, were sore to the touch. I developed a headache and stiff/painful neck. I felt very fatigued. About two days later I noticed a small itchy bump behind my knee. Over the next few days I developed 5 more bumps on my torso and thigh. The bumps ended up scabbing over in the middle. 18 days after the injection, my headache has resolved. The bumps are still scabbed over but I haven't developed anymore bumps. However, my neck is still very stiff and painful. I do not have very good range of motion from this. The rash has disappeared on my arm and turned into a bruise. My arm aches from shoulder to wrist and I have had a few muscle spasms.
LITTLE SORENESS IN NECK; LITTLE HEADACHE/HEADACHE WAS KIND OF SINUS HEADACHE; This spontaneous report received from a patient concerned a 53 year old female. The patient's height, and weight were not reported. The patient's past medical history included Covid, and concurrent conditions included neck soreness.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805029, and expiry: UNKNOWN) dose was not reported, administered on 19-MAR-2021 for prophylactic vaccination on Left arm. No concomitant medications were reported.  On JUN-2020, the subject experienced little soreness in neck. On MAR-2021, the subject experienced little headache/headache is kind of sinus headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the little headache/headache is kind of sinus headache and little soreness in neck was not reported. This report was non-serious.
Administration event: patient received Pfizer vaccine for second dose instead of Moderna.  Error discovered after vaccine administration.
blackouts; Bad rash all over body, itching, fast heartbeat, dizziness, constant headache, feeling tired all the time, cramping in stomach constantly, burning sensation in right foot and pressure in bowel movemen; Bad rash all over body, itching, fast heartbeat, dizziness, constant headache, feeling tired all the time, cramping in stomach constantly, burning sensation in right foot and pressure in bowel movemen; Bad rash all over body, itching, fast heartbeat, dizziness, constant headache, feeling tired all the time, cramping in stomach constantly, burning sensation in right foot and pressure in bowel movemen; Bad rash all over body, itching, fast heartbeat, dizziness, constant headache, feeling tired all the time, cramping in stomach constantly, burning sensation in right foot and pressure in bowel movemen; Bad rash all over body, itching, fast heartbeat, dizziness, constant headache, feeling tired all the time, cramping in stomach constantly, burning sensation in right foot and pressure in bowel movemen; Bad rash all over body, itching, fast heartbeat, dizziness, constant headache, feeling tired all the time, cramping in stomach constantly, burning sensation in right foot and pressure in bowel movemen; Bad rash all over body, itching, fast heartbeat, dizziness, constant headache, feeling tired all the time, cramping in stomach constantly, burning sensation in right foot and pressure in bowel movemen; Bad rash all over body, itching, fast heartbeat, dizziness, constant headache, feeling tired all the time, cramping in stomach constantly, burning sensation in right foot and pressure in bowel movemen; pressure in bowel movements,; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 59-years-old female patient received 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), at the age of 59-years-old via an unspecified route of administration, administered in Arm Right on 28May2021 16:00 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation.  Medical history included chronic obstructive pulmonary disease. No known allergies.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  Prior to vaccination, the patient was not diagnosed with COVID-19.  Since the vaccination, the patient had not been tested for COVID-19. The patient's concomitant medications were not reported.  The patient experienced bad rash all over body, itching, fast heartbeat, dizziness, constant headache, feeling tired all the time, cramping in stomach constantly, burning sensation in right foot and pressure in bowel movements, having blackouts on 28May2021 16:00. The adverse event resulted in: Doctor or other healthcare professional office/clinic visit. Treatment was received including Horticozone Shot.  The outcome was recovering. Seriousness was reported as yes.  Information on the Lot / Batch number has been requested.
Got chills and muscle aches, shivering,  headache. Just like the flu.
No additional AEs were reported; Improperly stored vaccine administered; This spontaneous report was received from the licensed practical nurse who refers to a patient of unknown age an gender. The patient's concurrent conditions, medical history and concomitant medications were not reported.   On 22-MAR-2022, the patient was vaccinated with an improperly stored 1 dose of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB); (lot number: U026217 verified as valid with expiration date: 02-NOV-2023 (route of administration was not reported). On the same date, the patient was also vaccinated with improperly stored 1 dose of rotavirus vaccine, live, oral liquid, pentavalent (ROTATEQ) administered via oral route (as default) (lot # u026664 verified as valid with expiration date: 24-FEB-2023 or lot # 1741817 verified as valid with expiration date: 30-JUL-2022 (the nurse didn't know, which exactly lot # was administered to this specific patient)) (product storage error). Strength, dose, dose number of aforementioned vaccines were not reported, all were administered for prophylaxis. The temperature to which the vaccines were exposed was 34.3 degree of Fahrenheit (34.3F) and the time frame was reported as 55 minutes. No previous temperature excursion was reported. It was unknown if a digital data logger was involved. No adverse symptoms were reported.  This is one of 33 reports received from the same reporter.; Sender's Comments:  US-009507513-2204USA001821: US-009507513-2204USA001791: US-009507513-2204USA001816:
Fifteen minutes after the vaccine was administered the patient broke out in a rash on his stomach, back, diaper area and face. The patient's hands, feet and face became pale and clammy. The patient was treated with Benadryl.
Unconsciousness; Feeling discomfort within a few minutes after the vaccination; A spontaneous report was received from a healthcare professional concerning a 78-year-old, female patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced of feeling discomfort within a few minutes after the vaccination, followed by unconsciousness and death.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On an unspecified date, prior to the onset of the event, patient received their dose of mRNA-1273 (Batch Number: Unknown) for prophylaxis of COVID-19 infection.  On an unspecified date, the patient experienced feeling discomfort within a few minutes after the vaccination, followed by unconsciousness and death.  Treatment information for event unconsciousness included resuscitate via cardiopulmonary resuscitation with no success.  Action taken with mRNA-1273 in response to the events was not applicable.  The outcome of the event unconsciousness was fatal and patient died.; Reporter's Comments: This is a case of death of a 78-year-old, female patient who experienced   within a few minutes of product use who experienced feeling of discomfort and became unconscious and subsequently expired. Based on the current available information, a strong temporal association between the product use and onset of the events, a causal relationship with the events cannot be excluded. However, critical details such as the patient's medical history and actual cause of death is lacking.; Reported Cause(s) of Death: Unknown cause of death
Swollen; Hot; rash; big hives, sizes of a counter; Migraine and headache; Red arm; migraine and headache; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (Migraine and headache), ERYTHEMA (Red arm), PERIPHERAL SWELLING (Swollen), FEELING HOT (Hot) and RASH (rash) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced MIGRAINE (Migraine and headache), ERYTHEMA (Red arm) and HEADACHE (migraine and headache). On 22-Feb-2021, the patient experienced RASH (rash) and URTICARIA (big hives, sizes of a counter). On an unknown date, the patient experienced PERIPHERAL SWELLING (Swollen) and FEELING HOT (Hot). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at an unspecified dose and frequency and CETIRIZINE HYDROCHLORIDE (BENADRYL ALLERGY [CETIRIZINE HYDROCHLORIDE]) for Hives, at an unspecified dose and frequency. On 20-Feb-2021, MIGRAINE (Migraine and headache) and HEADACHE (migraine and headache) had resolved. At the time of the report, ERYTHEMA (Red arm), RASH (rash) and URTICARIA (big hives, sizes of a counter) had not resolved and PERIPHERAL SWELLING (Swollen) and FEELING HOT (Hot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
32 yo male received 2nd dose of Pfizer/BioNTech Covid19 vaccine. 3 days later developed itching and urticarial rash all over his torso, arms, and legs. Eyelids slightly swollen. No shortness of breath, tongue or lip swelling, wheezing, nausea, diarrhea, cough, fever. Presented to ED,  received diphenhydramine, famotidine, and methylprednisolone IV. Had significant improvement of urticarial rash and eyelid swelling. Patches still present. Discharged home on 5 day course of H1/H2 blocker and prednisone. After first Pfizer Covid19 vaccine dose, patient only had sore arm. In ED, chest xray has no radiographic evidence of an acute cardiopulmonary abnormality, PCR panel (Cepheid GeneXpert System) negative for Covid19, influenza A/B, RSV.  No new food or detergents in last couple days.  No other vaccines administered in last 30 days. This event is being described a couple hours after ED discharge. Unknown at this time if patches resolved with subsequent discharge home treatment.
Patient received varicella vaccine 1/15/19. She began having fever same day. On 1/16/19 she woke up to swelling of injection site 4 inches by 2 1/2 inches, redness and fever. Patient also reports nausea.
bilateral pulmonary emboli;  ER ultrasound of legs (no clots); CT scan showed PEs; administered 2 shots Lovenox; Rx 10 mg Eliquis 2x/day for 1 week, then 5 mg 2x/day.
Injection site pain, tiredness, headache, muscle pain, joint pain, injection site swelling and redness, and swollen lymph nodes
This case was reported by a pharmacist via call center representative and described the occurrence of cold sores lip in a 53-year-old female patient who received SHINGRIX (batch number B334Y, expiry date 17th October 2020) for prophylaxis. On 2nd June 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 4th June 2018, 2 days after receiving SHINGRIX, the patient experienced cold sores lip. On an unknown date, the outcome of the cold sores lip was unknown. The reporter considered the cold sores lip to be unrelated to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX vaccine in the left deltoid. The healthcare professional (HCP) stated that the patient developed cold sore on lips after receiving SHINGRIX vaccine.
Muscle aches in left arm felt right after shot given and has not gotten better after 1 month time. She will be seeing the MD.
Adverse events: fever, chills, muscle ache, fatigue, nausea, and vomiting  Time: started evening of 4/29 and continued into 4/30. Started feeling better by afternoon of 5/1 Treatments: Tylenol, Pedialyte, water
Patient received the novel h1n1 swine flu shot at school given by the County Health Unit. Patient developed severe stomach pains, diarrhea, and vomiting. Also, her kidney condition relapsed. As of 11/11/2009, patient's condition is still the same. She is unable to attend school at this time. Patient's parents informed pediatrician, nephrologist, and ER doctor of the shot. Patient must take predisolone for kidney relapse, Zantac and Phenergan for stomach. All doctors were unsure why this problem developed.
This spontaneous report was received from a nurse practitioner and refers to an adult patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 24-FEB-2017, the patient was vaccinated with one pediatric dose of VAQTA (lot # M027879, expiry date: 24-JAN-2017), intramuscularly. No side effect was reported. Additional information has been requested.
1st dose on 19Jan2021 and  2nd dose on 24Feb2021; This spontaneous case was reported by a patient and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose on 19Jan2021 and  2nd dose on 24Feb2021) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A2(Z)1A and 037K2(Z)0A) for COVID-19 prophylaxis.     Concurrent medical conditions included Drug allergy (Losartan), Diabetes and Blood pressure high.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose on 19Jan2021 and  2nd dose on 24Feb2021). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose on 19Jan2021 and  2nd dose on 24Feb2021) outcome was unknown.            Patient concomitant medications included diabetic and high blood pressure medications even before first dose of Moderna vaccine. Patient had no positive COVID test or diagnosis. Treatment information was not provided.   This case was linked to MOD-2022-588456 (Patient Link).
reporter blisters in and around her mouth; This case was reported by a nurse via sales rep and described the occurrence of blistering of mouth in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced blistering of mouth. On an unknown date, the outcome of the blistering of mouth was unknown.   It was unknown if the reporter considered the blistering of mouth to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. It was reported that the patient reported blisters in and around her mouth within the week of being vaccinated. The reporter was unsure if this would disqualify patient from dose two.  The reporter agreed to follow up.
Upon checking out patient passed out landing on floor.   Transferred care to Urgent Clinic per stretcher by MD and nurse
This Spontaneous case, initially received on 12-Apr-2017 was reported by an other non health professional and concerns a male patient of unknown age. Administration of Company suspect drug (s): On an unspecified date, the patient received FLUCELVAX QIV (batch number: KWK21APR17: dosage, expiration date, route of administration: not reported). Adverse reactions/events and outcomes: On an unknown date after receiving the flu shot (FLUCELVAX QIV), from pharmacy, the patient experienced pain in arm, also vaccination site pain which was almost for 5 months at the time of reporting. The patient stated that it had been hurting every time he wore a suit jacket and he could hardly lift any weight at all when he extended his arm in a particular direction due to pain. He consulted a physician who suspected a cyst caused by vaccination which turned to be nothing on ultrasound and wondered about a shoulder joint issue. The condition had been worsened for last 1 month. Action taken with FLUCELVAX QIV was not reported. The event was not recovered. Reporter's Assessment: The other non health professional assessed the events as non-serious and the causality for the events were related. This case was non-serious.
Mom described onset of symptoms after midnight on the day of vaccine. Symptoms included much irritability, but consolable by parent, jerking movements on arousal from sleep, greatly decreased responsiveness to verbal stimuli and primarily responsive to deep touch.
RED STAIN ON THE RIGHT SIDE OF BODY BELOW ARMPIT AND MORE RED STAINS AROUND IT; ITCHING; This spontaneous report received from a patient concerned a 59 year old male. The patient's height, and weight were not reported. The patient's past medical history included panic attacks, right knee surgery total replacement, obstruction in colon, colostomy placed and removed, 2 right shoulder surgeries, and 27 operations in total, and concurrent conditions included hypertension, arthritis, disabled, penicillin allergy, latex allergy, non-smoker, social alcohol user, and spasms, and other pre-existing medical conditions included the patient had no history of drug abuse or illicit drug usage. The patient experienced drug allergy when treated with acetylsalicylic acid for drug used for unknown indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1816022, expiry: UNKNOWN) dose was not reported, administered on 30-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 30-JUN-2021, the subject experienced itching. On 07-JUL-2021, the subject experienced red stain on the right side of body below armpit and more red stains around it. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from itching on JUL-2021, and had not recovered from red stain on the right side of body below armpit and more red stains around it. This report was non-serious.
Moderately sore arm; very mild drowsiness; Mildly sore arm at injection site; This is a spontaneous report from a contactable consumer (patient). A 22-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EP6955; Expiration date was not reported), via an unspecified route of administration in the left arm on 22Apr2021 15:30 (at the age of 22-years-old) as first dose, single dose for COVID-19 immunization at a facility or Health Clinic. Medical history included grass allergy, pollen allergy and other allergy (reported as etc.); all from an unknown date and unknown if ongoing. Concomitant medications included fluticasone nasal spray taken for an unspecified indication, start and stop date were not reported. No other vaccine was received by the patient in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient has not been tested for COVID-19. The patient experienced mildly sore arm at injection site on 22Apr2021 and moderately sore arm and very mild drowsiness on 23Apr2021. The outcome of the events was unknown. The patient was vaccinated with BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: ER8731; Expiration date was not reported), via an unspecified route of administration in the left arm on 13May2021 15:30 (at the age of 22-years-old) as second dose, single dose for COVID-19 immunization at a facility or Health Clinic.
Beginning about 3 days following 2nd Covid-19 vaccination, experienced onset of nerve pain left side of neck, back left shoulder, radiating down left arm. Constant pain - much worse during sleep. Unable to sleep, changing positions little help - better sitting up or in high recline in bed. Treating with Tylenol, Ibupropfen periodically. Applying cold compress and warm compresses alternatively. Tried analgesic cream rub with little success. Able to exercise with little change. Rubbing of neck muscles helps somewhat.