chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Left arm was sore at the injection site; She has a rash around the area she received injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Left arm was sore at the injection site) and VACCINATION SITE RASH (She has a rash around the area she received injection) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Oct-2021, the patient experienced VACCINATION SITE PAIN (Left arm was sore at the injection site) and VACCINATION SITE RASH (She has a rash around the area she received injection). At the time of the report, VACCINATION SITE PAIN (Left arm was sore at the injection site) and VACCINATION SITE RASH (She has a rash around the area she received injection) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.  Treatment medications were not provided by the reporter.   Reporter did not allow further contact
Pt's arm got significantly red and swollen (from injection site to below elbow)-painful to touch and very swollen. Right arm.
pt recvd vax & exp inject site react; pt devel red, swollen, hot area; not seen in office; treatment included warm compresses;
DIZZINESS; WEAKNESS; FELT SICK; HEADACHE; PAIN ON RIGHT ARM; SLEEPLESSNESS; This spontaneous report received from a patient concerned a 57 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included sulfa allergy, and naproxen allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and expiry: UNKNOWN) dose was not reported, administered on 03-APR-2021 at 10:45 AM on right arm for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced sleeplessness. On APR-2021, the subject experienced pain on right arm. On 04-APR-2021, the subject experienced dizziness. On 04-APR-2021, the subject experienced weakness. On 04-APR-2021, the subject experienced felt sick. On 04-APR-2021, the subject experienced headache. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from headache, dizziness, and weakness, and the outcome of sleeplessness, pain on right arm and felt sick was not reported. This report was non-serious.
Client had already reveived her flu shot, 0.5cc Fluarix Lot # AFLUA697AA Expiration date: 6/30/13 from GlaxoSmithKline in her left deltiod muscle at 1620 hours.  Client waited 10 minutes in the gym with her mother, then they were in the hall talking with friends the last five minutes when the client vomited and got light headed.  The client's mother brought her back into the gym where this nurse was.  The client had a pale complexion.  This nurse sat the child down in a chair.  The client's blood pressure was 90/54, pulse 82, respirations 18.  This nurse applied a cold pack wrapped in paper to the back of the child's neck, then got a chair for the client to put her feet up.  The client rested there for 25 minutes without anymore dizziness or vomiting.  The client then sat up in the chair for 5 minutes without change, then stood up for another 5 minutes without change.  The client stated she did not have anymore dizziness or nausea.  The child left accompanied by her mother.
Brused left arm, very red, swollen and hot. Patient will take today, 5 days later oral benadryl and topical hydrocortison, will seek medical treatment at 1:00pm today.
COVID; COVID; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 82-year-old female patient received BNT162b2 (BNT162B2), on 21Jan2021 as dose 1, single (Lot number: 663249), in arm, on 11Feb2021 as dose 2, single (Lot number: EL9262), in arm, on 27Sep2021 as dose 3 (booster), single (Lot number: FC3184), in arm and on 12Apr2022 at 13:00 as dose 4 (booster), single (Lot number: FJ4991) at the age of 82 years, in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Macrobid for UTI infection, reaction(s): "Chills", notes: symptoms went away when stopped; Antibiotics, reaction(s): "Fainted", notes: When on the antibiotic, fainted both times. Vaccination history included: Shingles (Dose: 1 at arm, need another one but century), for Immunization; Polio (when a child), for Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; Negative; Negative; Negative. Therapeutic measures were taken as a result of vaccination failure, covid-19.
AUTOINOCULATION OF LABIA MINOR, 8MM ULCERATION NOTED LATERAL TO FOSSA NAVICULARIS ON RIGHT AND LEFT LABIA MINORA. PUSTULE PRESENT ON RIGHT, SCAB/POSTULE ON LEFT. RESOLVING.
No side effects were experienced until 2 days after I received the vaccine.  Two days after I received the vaccine I experienced enlarged lymph nodes on the left side of my back. I experienced pain when I pressed on my back. The pain felt like sore muscles so I used a heating pad which did not alleviate the issue. The enlarged lymph nodes continued to increase to include pain from my left arm pit down my left arm to my forearm and shoulder blade. It also increased down my back into my left buttock and upper thigh. As of today, March 16, 2021 at 3pm, the pain has slightly decreased.
Her doctor asked to wait 90 days to get her 2nd dose; Shaking and shaking; Sick at my stomach; Gagging; Myalgia; Head was hurting so bad; Got Covid after getting 1st dose of vaccine; Coughing; Couldn't walk; Did not have appetite; Didn't taste nothing; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Her doctor asked to wait 90 days to get her 2nd dose), COVID-19 (Got Covid after getting 1st dose of vaccine), COUGH (Coughing), GAIT DISTURBANCE (Couldn't walk) and TREMOR (Shaking and shaking) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, the patient experienced COVID-19 (Got Covid after getting 1st dose of vaccine), COUGH (Coughing), GAIT DISTURBANCE (Couldn't walk), DECREASED APPETITE (Did not have appetite), AGEUSIA (Didn't taste nothing), MYALGIA (Myalgia) and HEADACHE (Head was hurting so bad). On 05-Mar-2021, the patient experienced ABDOMINAL DISCOMFORT (Sick at my stomach) and RETCHING (Gagging). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Her doctor asked to wait 90 days to get her 2nd dose) and TREMOR (Shaking and shaking). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Her doctor asked to wait 90 days to get her 2nd dose) outcome was unknown and COVID-19 (Got Covid after getting 1st dose of vaccine), COUGH (Coughing), GAIT DISTURBANCE (Couldn't walk), TREMOR (Shaking and shaking), DECREASED APPETITE (Did not have appetite), AGEUSIA (Didn't taste nothing), ABDOMINAL DISCOMFORT (Sick at my stomach), RETCHING (Gagging), MYALGIA (Myalgia) and HEADACHE (Head was hurting so bad) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Feb-2021, SARS-CoV-2 test: (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were provided No Treatment information provided    Most recent FOLLOW-UP information incorporated above includes: On 09-Jul-2021: TCR  is non-significant
expired Menveo administered; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA710A, expiry date 30-APR-2023) for prophylaxis.   On 03-MAY-2023, the patient received Menveo. On 03-MAY-2023, an unknown time after receiving Menveo, the patient experienced expired vaccine used (Verbatim: expired Menveo administered).  The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 29-SEP-2023 The nurse practitioner requested expiration data for Menveo as expired vaccine was administered to a patient which led to expired vaccine used. The nurse practitioner disconnected chat without providing requested patient demographics or agreeing to safety team follow up, stating that she will reach out again with any additional questions.
Immediately post vaccine administration, individual became pale, diaphoretic, limp, nauseous
35 patints exposed to vaccine from which vial may have been punctured more than 20 times; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT ADMINISTRATION ERROR (35 patints exposed to vaccine from which vial may have been punctured more than 20 times) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Nov-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (35 patints exposed to vaccine from which vial may have been punctured more than 20 times). On 04-Nov-2021, PRODUCT ADMINISTRATION ERROR (35 patints exposed to vaccine from which vial may have been punctured more than 20 times) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.  Patient year of birth was provided as .
Late March 2021: chest pain emerged a few days after 2nd Moderna vaccine; lasted ~ 1 week. I think mostly or entirely on non-heart side. Mid-May 2021: came back on heart side (when laid down to sleep, couldn?t sleep on heart side without grimacing in pain). Besides that, most of the time was mild to moderate. Chest pain would switch between left and right sides.  5/18/21: Saw Dr. (primary care). You forgot to mention you first felt the pain after your second COVID dose. Dr. thought it was muscular (EKG came back normal) and said to pause weightlifting to be safe. During this, probably had a cold for 2 full weeks (bad congestion, sore throat for part of it, body and head aches). You were advised to try Ibuprofen ? tried it for a day or so and it didn?t help, so you stopped. 5/20/21: Messaged Dr. about vaccine timing (right when reports started to come out that there could be link between Pfizer/Moderna and rare heart inflammation in men under 30), who suggested seeing a cardiologist to be safe
cough. I always had it but it's worse now; heaviness in the chest a little bit; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (BNT162B2, Batch/Lot number was not reported) via an unspecified route of administration on 18Sep2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. It was reported that on an unspecified date, the patient experienced cough. i always had it but it's worse now, heaviness in the chest a little bit. It was reported that "patient have a cough. patient always had it but it's worse now. Patient also experiencing heaviness in the chest a little bit. Reports wants to know if these symptoms are related to Pfizer COVID-19 vaccine. The outcome of event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Got vaccines AM of 9/7/12. Fever started PM of 9/7/12 and continued for one week. Neck erythema/swelling started on 9/12/12.
Markedly swollen, pink, warm arm day after vaccine given. Ibuprofen, Benadryl.
Little sore in the face; Soreness in the gums; Tooth infection; Strange headache; This spontaneous case was reported by a consumer and describes the occurrence of FACIAL PAIN (Little sore in the face), GINGIVAL PAIN (Soreness in the gums), TOOTH INFECTION (Tooth infection) and HEADACHE (Strange headache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FACIAL PAIN (Little sore in the face), GINGIVAL PAIN (Soreness in the gums), TOOTH INFECTION (Tooth infection) and HEADACHE (Strange headache). At the time of the report, FACIAL PAIN (Little sore in the face), GINGIVAL PAIN (Soreness in the gums), TOOTH INFECTION (Tooth infection) and HEADACHE (Strange headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Based on the information provide, the causal association between the reported events and the administration of the mRNA-1273 vaccine is assessed as unlikely.  Event is assessed as due to the underlying infection although headache is consistent with the known profile of the vaccines.  Tooth infection causing pain has also been found to cause headaches.; Sender's Comments: Based on the information provide, the causal association between the reported events and the administration of the mRNA-1273 vaccine is assessed as unlikely.  Event is assessed as due to the underlying infection although headache is consistent with the known profile of the vaccines.  Tooth infection causing pain has also been found to cause headaches.
Nausea and fevers started at 4:30 am 14 hours after shot, had nausea, body aches, headache, fever up to 101.2 , dizziness, fatigue. Nausea lasted 72 hours after the shot and has not stopped though has gotten better.
About 23.5 hours after the vaccination, I developed the chills and shortness of breath while out on a walk. Once home, I had chills, body ache, and an overall feeling of having a high fever, but my temperature was only just above 99 degrees F. I was intensely fatigued. The symptoms lasted intensely for 36 hours (with temp reaching 101), after which I gradually felt better each day, but wasn't back to normal until the 4th morning after onset of symptoms.  (After my second dose, I had the same reaction, but it started sooner and ended earlier.) I have not had any known case of COVID-19.  Treatment: Due to a warning when I received my shot, I did not take anything for the fever.
Chills; Chills, then hot; Loss of motor skills from weakness; Nausea; Slept almost 24 hours; Some body aches; This is a spontaneous report from a contactable consumer, the patient. An 88-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6203) via an unspecified route of administration in the right arm on 25Feb2021 at 15:15 (at the age of 88-years-old) as a single dose for COVID-19 immunisation. The medical history included Atrial fibrillation (afib) and stroke on 15Nov2020 and the patient was recovering from stroke at the time of report. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The concomitant medications included apixaban (ELIQUIS), atorvastatin calcium (LIPITOR), escitalopram oxalate (LEXAPRO), losartan potassium (COZAAR), Breo(unspecified), sy (unspecified) and montelukast sodium (SINGULAR). The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN5318) via an unspecified route of administration in the right arm on 04Feb2021 at 15:00 (at the age of 88-years-old) as a single dose for COVID-19 immunisation. On 25Feb2021, the patient experienced chills, then hot, loss of motor skills from weakness, nausea, slept almost 24 hours and some body aches. The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events chills, then hot, loss of motor skills from weakness, nausea, slept almost 24 hours and some body aches were resolved on an unknown date in Feb2021.   No follow-up attempts are needed. No further information is expected.
PATIENT STATED HE HAS A MILD/SPLOTCHY RASH ON BOTH ARMS, AND CHEST/NECK AREA
Client seen for routine visit and public health department 03/06/2023. Requested covid bivalent booster. Client incorrectly received covid primary booster 0.3ml IM right deltoid at 02:10pm instead. Client made aware of error immediately upon discovery on 03/06/2023 at 04:00pm.
Initial report received on 07 September 2007 from a consumer's parent.  A two month-old female patient, who had no concurrent illnesses, had received a dose of ActHIB; a dose of DTaP (Trade name and manufacturer name not reported); a dose of IPOL; and a dose of "Hep B" (Trade name and manufacturer name not reported) on an unspecified day in July 2005.  The lot numbers, routes and sites of administration were not reported for any of the vaccines.  Pre-existing medical conditions and use of other medications were not reported.  The parent reported the patient developed a "skin condition" after receiving the above-mentioned vaccines, which required a doctor visit (dates not provided).  The patient had received the vaccines at two months of age and is now two years old, and her skin condition persists.  Treatment and diagnostic testings were not provided.  The reporter would not provide the contact information for the responsible physician for follow-up.  At the time of this report, the patient had not recovered.
Approximately 30 minutes after injection, heart rate increased, warm flush was felt in the forehead.  Event lasted about 1 minute
Injected the Moderna Vaccine into the joint space of proximal head of right humerus/posterior; Pain raditaing from injection site to right hand; local aching pain 5-6(10) at site; Fever; A spontaneous report received from a Consumer concerning, 72-year-old female patient who received 2nd dose of the Moderna COVID-19 vaccine that was not injected into the muscle. /MedDRA PT: [Injection error]  ~ The patient's medical history included Asthma. Patient's concomitant was not included.   On 05-FEB-2021 date, the patient received their 2nd dose of the two planned doses of mRNA-1273 in right arm (Batch #: unknown) intramuscularly for prophylaxis of COVID-19 infection.   Patient stated the she received her 2nd dose of the Moderna COVID 19 vaccine on 05FEB2021 and the person who gave the vaccine, injected the Moderna COVID-19 vaccine into the joint space of proximal head of right humerus/ posterior. Patient stated that the injection was exquisitely painful for 3 days and she had a fever of 101.2. Patient stated that she had local aching pain 5-6(10) days and radiating pain from injection site to right hand for 4 days. Patient stated that she would like to know is the dose invalid since it was not given intramuscularly. Dose she needs to repeat  2nd dose of the vaccine. What are the concerns injecting into tendon/ ligament?  Treatment information was not provided/ unknown.  Action taken with mRNA-1273 in response to the event was not applicable.  The outcome of the event was resolved.; Reporter's Comments: This report refers to a case of  inappropriate route of administration with reported non-serious events of pain in extremity, fever, and vaccination site pain. 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.
Saturday, 3/7. child had a fever (really hot) at 1:30 Am. Given ibuprofen and slept in a diaper. Child was crabby around noon. Mom thought teeth were bothering her so gave a dose of ibuprofen. Child was fine until 6:30-7 pm. Child felt warm but was not given anything. Played in the pool until child stared off and then eyes rolled back and child started twitching. Ambulance called and temp was 103.1. From motel to hospital child came around. Mom said seizure was about 1-3 minutes. Temp at ER was 100.9 rectally. ER gave ibuprofen. Parents were told child had a febrile seizure. Child has been fine since episode.
Red & swollen eye lid to cheek bone. Burns slightly. Pt did cool compress to eye & antihistamine x5 days.
erythema 06/08 and swelling in LA from 06/09 from upper arm to forearm.
After administering 4 vaccines, patient fainted lasting approximately 5 sec - 108 C of LOC.  Layed patient down and he woke up and felt ok.  Had patient lay on table, gave pretzels and juice.  VSS.  Patient discharged with mom feeling fine.  Ambulated well.
Skin inflammation issues occurred within a month of receiving the vaccination. Acne, Atopic dermatitis (AD) and psoriasis (PS), Rosacea, Eczema
I?m currently 13 days post vaccine.  I?m experiencing constant dizziness and headaches     My right arm was numb for approx 12 days afterwards.
STOMACH PAIN; This spontaneous report received from a parent concerned an 18 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and expiry: UNKNOWN) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced stomach pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of stomach pain was not reported. This report was non-serious.
Patient was given an injection that had expired 10 days prior to injection. Patient did not have any adverse reaction to the immunization at this point.
On 2/11/20, patient reported having sore left arm upon first Shingrix vaccine on 9/10/19 and second Shingrix vaccine on 12/23/19.  She reports soreness occurs when she tries putting left arm above her head or behind back. Soreness has persisted.
No further AE's were reported; An expired dose of GARDASIL 9 was administered to a patient; This spontaneous report was received from a nurse concerning to a patient of unspecified age and gender. The patient's medical history, concurrent conditions or concomitant medications were not reported.  On 28-DEC-2021, the patient was vaccinated with an expired dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (0.5 ml one time, lot #S010729, expiration date 01-DEC-2021; strength and route were not reported) for prophylaxis (expired product administered). Vaccine had not undergone a temperature excursion. No further adverse events were reported.  This is one of several reports from the same reporter. ; Sender's Comments:  US-009507513-2202USA003627: US-009507513-2202USA003751: US-009507513-2202USA003516: US-009507513-2202USA003778: US-009507513-2202USA003414: US-009507513-2202USA003522: US-009507513-2202USA003543: US-009507513-2202USA003651: US-009507513-2202USA003569: US-009507513-2202USA003660: