chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine leaked out between needle and syringe/ >1/2 of 0.5 ml volume was administered; malfunction between the needle and syringe/ syringe/needle mlfxn; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (Vaccine leaked out between needle and syringe/ >1/2 of 0.5 ml volume was administered) and DEVICE CONNECTION ISSUE (malfunction between the needle and syringe/ syringe/needle mlfxn) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, the patient experienced UNDERDOSE (Vaccine leaked out between needle and syringe/ >1/2 of 0.5 ml volume was administered) and DEVICE CONNECTION ISSUE (malfunction between the needle and syringe/ syringe/needle mlfxn). On 09-Apr-2021, UNDERDOSE (Vaccine leaked out between needle and syringe/ >1/2 of 0.5 ml volume was administered) and DEVICE CONNECTION ISSUE (malfunction between the needle and syringe/ syringe/needle mlfxn) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant or treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 19-Jul-2021: Follow up received and contain non significant information.
pharmacist concerning a 95 year old male with no allergies who on 02-NOV-2009 was vaccinated with a dose of PNEUMOVAX 23 (Lot number. 665300/1314Y) there was no history of the patient receiving PNEUMOVAX 23 in the past. Concomitant therapy included ROBITUSSIN, LASIX, PROTONIX AND aspirin. The reporter mentioned that on 15-NOV-2009 a patient very active and oriented, experienced altered mental status with confusion and disorientation. The patient was admitted to the hospital for the symptoms. The reporter stated that no urinary tract infection was noted and no change in environment until hospitalization. The patient was being treated with CIPRO and SEROQUEL. A complete metabolic blood test was performed with no results reported. The pharmacist mentioned that the patient remains in the hospital and he has not recovered at the time of reporting. Additional information has been requested.
Received high dose Flu vaccine 10/22/10 AM. On 10/25 reported to clinic that she had developed "flu like sx" the next AM. Also developed rash on arms & trunk of body this progressed to continuous coverage of these areas of body - minimal itching - lasted for 2 days.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Mar2021 as dose 1, single (Lot number: EN6202), in right arm, on 06Apr2021 as dose 2, single (Lot number: EP7533), in right arm, on 08Nov2021 as dose 3 (booster), single (Lot number: Ff2590), in right arm and on 23May2022 as dose 4 (booster), single (Lot number: FM9992) at the age of 53 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Sulfa" (unspecified if ongoing), notes: known allergies: Sulfa. The patient's concomitant medications were not reported. Past drug history included: Bactrim, reaction(s): "Known allergies: Bactrim", notes: Known allergies: Bactrim. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative, notes: After testing negative 9 days since onset of symptoms and 3 days following Paxlovid treatment, I tested positive for COVID-19 5 days after completing Paxlovid and 2 days after testing negative; (05Jan2023) Positive, notes: After testing negative 9 days since onset of symptoms and 3 days following Paxlovid treatment, I tested positive for COVID-19 5 days after completing Paxlovid and 2 days after testing negative. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: Paxlovid rebound. After testing negative 9 days since onset of symptoms and 3 days following Paxlovid treatment, I tested positive for COVID-19 5 days after completing Paxlovid and 2 days after testing negative.
Patient reported extremely painful muscle pain and about one & half inch diameter sized swelling without any change in her skin color.
cold; shaking; fever; vomiting; 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 NASOPHARYNGITIS (cold), TREMOR (shaking), PYREXIA (fever) and VOMITING (vomiting) 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 NASOPHARYNGITIS (cold), TREMOR (shaking), PYREXIA (fever) and VOMITING (vomiting). At the time of the report, NASOPHARYNGITIS (cold), TREMOR (shaking), PYREXIA (fever) and VOMITING (vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment medications were reported.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Feb2021 as dose 1, single (Lot number: el9269), in right arm, on 03Jun2021 as dose 2, single (Lot number: en6098), in left arm and on 04Nov2021 as dose 3 (booster), single (Lot number: 30145BA) at the age of 50 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "Thyroid" (unspecified if ongoing). Patient had no known allergies. Concomitant medication(s) included: LEVO [LEVOFLOXACIN] taken for thyroid disorder, start date: Sep2018. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient received Paxlovid from 12Jun2022 to 14Jun2022, for the treatment of COVID-19.  No follow-up attempts are possible. No further information is expected.
Raised maculopapular rash, burning, plaques starting on upper extremities, eventually spreading to the legs, then to the trunk. Plaques eventually coalesced together forming larger plaques and raised macules. Started on the inner arms, then was noted on the outer thighs, which spread to the buttock, then up the back. As plaques began to heal, new raised papules and plaques would surface in other areas of the body. Plaques and raised papules caused Itching, burning, bleeding, which caused scratching so bad there was bruising and bleeding noted around the affected areas. Resolved with time, 14 days, and antihistamine as needed.
CHEMOTHERAPY INDUCED PERIPHERAL NEUROPATHY, INIT CHRONIC HYPOXEMIC RESPIRATORY FAILURE
Around March of 2022, I began to have fatigue and some balance issues. I had already had some balance issues, but they got grossly worse. The fatigue worsened greatly. It was relieved by short naps, but it was pretty significant. I had an episode where were walking and I couldn't move one of my legs. It wasn't bone or anything, I just couldn't move. That lasted for maybe 3 or 4 minutes. During my daughter's wedding, I had to go lie down because I was so fatigued. The fatigue just kept increasing. The motor control kept getting worse. The exhaustion was increasing to the point where I had to take a leave from work in October of 2022. It just kept progressing. My legs, arms, shoulders, and hands. I've seen 2 neurologists, a pulmonologist, and a cardiologist. Nobody can really figure out what is going on. They can see the weakness, exhaustion, blurry vision, and double vision, which are all pretty significant.
1.   9/3/2021  ca 7:00 am (approx 15 hours after vaccine):  Extreme "covid toes" on left foot:  entire extent of two middle toes deep and shiny purple like eggplant.  Observed by podiatrist 1130 am same day, by which time the deep shiny coloration had subsided to appearance of badly bruised toes.    2.  9/5/2021.  Patient suddenly weak with gait, arms, unable to properly walk.  MRI on 9/17/2021 confirmed major stroke.
the day p/vax pt devel joint pain & mild swelling & stiffness in fingers, wrists, elbows, spine, knees, ankles;
Muscle Pain; Fatigue; Ringing in Ears; Headache; Stomach Ache; Nausea; Soreness at Injection Site; Redness at Injection Site; Bruising; Being down; This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In December 2019, the patient received the 1st dose of Shingrix. In December 2019, less than 2 weeks after receiving Shingrix, the patient experienced muscle pain, fatigue, ringing in ears, headache, stomach pain, nausea, injection site pain, injection site erythema, contusion and feeling abnormal. On an unknown date, the outcome of the muscle pain, fatigue, ringing in ears, headache, stomach pain, nausea, injection site pain, injection site erythema, contusion and feeling abnormal were recovered/resolved.   It was unknown if the reporter considered the muscle pain, fatigue, ringing in ears, headache, stomach pain, nausea, injection site pain, injection site erythema, contusion and feeling abnormal to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix 1 week ago and being down for 2 to 3 days and experienced muscle pain, fatigue, ringing in ears, headache, stomach ache, nausea,soreness and redness at the injection site, and bruising. The reporter declined to provide more information for safety report partly due to consumer reporting it to her doctor's office with the belief that the doctor's office reported her reactions.  The caller inquires if patient receive 2nd dose or not or partial dose. This case has been linked with case US2019AMR233004 , US2019AMR233005, reported by same reporter.
Body aches; fatigue; This is a spontaneous report from a contactable consumer (patient). A 45-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number: EL3247, Expiration date was not reported), via an unspecified route of administration (administered on the left arm) on 10Feb2021 at 14:30 (at the age of 45-years-old) as dose 2, single for COVID-19 immunisation. Medical history included known allergies to ketamine. The patient has no other concomitant medications in two weeks. The patient didn't receive any other vaccines within 4 weeks prior to COVID vaccine. Prior to vaccination, the patient has not been diagnosed with COVID-19. The patient was previously vaccinated with the first dose of BNT162B2 (COMIRNATY, Solution for injection; Lot number: EL3247, Expiration date was not reported), via an unspecified route of administration (administered on the left arm) on 20Jan2021 at 13:00 (at the age of 45-years-old) for COVID-19 immunisation. On 11Feb2021 at 02:30, the patient experienced body aches and fatigue. No treatment was received for the events. Since the vaccination the patient has not been tested for COVID-19. The outcome of the events was recovering.  No follow-up attempts are possible. No further information expected.
Severe joint pain, myalgias and shaking chills. Possible low grade fever. Did not seem consistent with severity of shaking chills.
Starting the morning after his vaccine, the pt experienced sharp pains in chest and difficulty breathing that lasted 30 seconds to 1 minute sporadically up to 3 episodes per hour for 7 to 10 days. Starting 7 days after vaccine, pt began experiencing severe burning in the abdomen overnight from midnight to 4 am keeping him from sleeping anytime he would have foods high in acid or spicy foods.
This spontaneous report was received from a pharmacist refers to a female patient of unknown age. Medical history and concurrent conditions were not reported. On 14-OCT-2014 at 07:00 hours, the patient was vaccinated with PNEUMOVAX 23 injection in the left arm (dose, frequency, route, lot number unknown) for unknown indication from an unspecified provider. Concomitant therapies included MOBIC. On 14-OCT-2014, 20:00 hours the patient experienced fluid build-up between her left shoulder and neck. The area was sore and the size of an egg. It was reported that the patient had never received PNEUMOVAX 23 in the past. On an unknown date (reported as compared to yesterday) the patient reported that the fluid buildup had reduced. Patient sought medical attention as she spoke to pharmacist. The outcome of the events was unknown. Causality of the events were unknown. No product quality complaint (PQC) was involved. Additional information is not expected because patient was not a patient at the pharmacy.
This spontaneous report received from a patient via a company representative via social media concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced felt drained for 2 days. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt drained for 2 days. This report was non-serious.
Inject site pain; muscle/joint pain; muscle/joint pain; fever with temperature of 99-100.6 [units unspecified]; under arm lymph node pain; headache; This is a spontaneous report from a contactable healthcare professional. A 41-year-old non-pregnant female patient received her second dose of bnt162b2 (BNT162B2 reported as COVID-19 vaccine; lot number: EL1284; expiration date: unknown), intramuscular left arm on 08Jan2021 08:45 AM at a single dose for covid-19 vaccination. Medical history included asthma, allergies, high blood pressure and gastric sleeve. Concomitant medication included albuterol [salbutamol] (ALBUTEROL [SALBUTAMOL]), beclometasone dipropionate (QVAR), mometasone furoate (FLONASE), aminobenzoic acid, calcium pantothenate, cyanocobalamin, nicotinamide, pyridoxine hydrochloride, riboflavin, thiamine hydrochloride (B-COMPLEX), cyanocobalamin (B-12), colecalciferol (D) and macrogol 3350 (MIRALAX). The patient previously took vancomycin but had allergies. The patient received the first dose of bnt162b2 (BNT162B2 reported as COVID-19 vaccine; lot number: EK5730; expiration date: unknown) intramuscular left arm on 18Dec2020 07:45 AM at a single dose for covid-19 vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient received the most recent COVID-19 vaccine in a hospital. The patient experienced inject site pain, muscle/joint pain, fever with temperature of 99-100.6 [units unspecified], under arm lymph node pain and headache on 09Jan2021 23:30. The events were considered as non-serious. The treatment the patient received for the adverse event were acetaminophen (TYLENOL), fluids, ice packs and magnesium. The patient has not been tested for COVID-19 since the vaccination. The patient underwent lab tests and procedures which included temperature was 99-100.6 [units unspecified] on 09Jan2021. The outcome of the events was recovering.
For about 5 hours patient would cry out like he was in pain, continue crying for a few minutes, then calm down and acted happy. Then he would cry out in pain again, cry for a few min, and this continued for 4 hours on January 14th and 15th from about 5:00-10:00 pm. Diarrhea also began on January 16th.
5 yo male p/w arm pain, erythema, swelling and decreased ROM s/p receiving flu vaccine 2 days ago. Mom reports some initial difficulty moving his arm after receiving the vaccine. Yesterday afternoon, mom noticed that his entire upper arm appeared red, swollen and warm to the touch. Mom reports today he is moving his arm a little more though the redness and swelling seems slightly worse. Denies fever. Otherwise acting at baseline. Eating and drinking well. No treatments tried. No previous adverse reaction to vaccines per report. A: Cellulitis of left upper arm; adverse effect of influenza vaccine; P: - BENADRYL 12.5 mg/5 mL liquid 25 mg; Take 10 mLs (25 mg per dose) by mouth once given in office. - KEFLEX 250 mg/5 mL suspension; Take 5.3 mLs (265 mg per dose) by mouth 2 (two) times daily for 10 days. Dispense: 106 mL; Refill: 0 - F/u in 2 days.
Received vaccination on the fifth of April, in the earlier morning of the sixth I work up to stomach pains..they had me doubled over had to crawl to bathroom. The morning of the seventh the pain was goon almost 24 hours later..No more problems until the early morning of the 12th a week later same stomach pain, chills, headache.  Early the next morning I still had a slight headache and slight stomach pain. Went to ER they gave me fluid because I had no appetite so I hadn?t eaten or drank anything for two days. They did blood work but said I was o
Patient given PNEUMOVAX injection on 4-27-2010 (right arm) after 24 hrs developed.  In the right arm when she received vaccine increased swelling, pain and redness which worsened after 48 hrs.  Sent pt. to ER where they treated pt. for cellulitis and started on KEFLEX 500 mg X 28 days.
Left thigh with 6 1/2 x 7 1/2 cm area of redness and swelling.  Benadryl 12.5/5 - 1 tsp 4 times a day for 7 days.
Fatigue, body aches, low grade fever, nausea for the entire day 5/4/21
Mother noted increased redness, swelling and area warm to touch; was advised to use cool compresses and monitor. Child was seen by physician 9/21/11; recommended po Benadryl and cool compresses.Was seen again on 09/29/11: slowly resolving local reaction; no further followup recommended.
Site: Swelling at Injection Site-Mild, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Itch Generalized-Severe, Systemic: Allergic: Rash Generalized-Severe, Systemic: Abdominal Pain-Mild, Systemic: Body Aches Generalized-Medium, Systemic: Chills-Mild, Systemic: Confusion-Mild, Systemic: Diarrhea-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fever-Mild, Systemic: Flushed / Sweating-Severe, Systemic: Headache-Mild, Systemic: Nausea-Severe, Systemic: Tingling (specify: facial area, extemities)-Medium, Systemic: Tinnitus-Severe, Systemic: Visual Changes/Disturbances-Medium, Systemic: Vomiting-Severe, Systemic: Weakness-Medium
coughing - dry cough; weakness; flushed a little bit; Not hungry have not had dinner no breakfast, No appetite; voice is deeper; Headache; tiredness; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (coughing - dry cough), ASTHENIA (weakness), FLUSHING (flushed a little bit), DECREASED APPETITE (Not hungry have not had dinner no breakfast, No appetite) and DYSPHONIA (voice is deeper) in a 72-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 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced COUGH (coughing - dry cough), ASTHENIA (weakness), FLUSHING (flushed a little bit), DECREASED APPETITE (Not hungry have not had dinner no breakfast, No appetite), DYSPHONIA (voice is deeper), HEADACHE (Headache) and FATIGUE (tiredness). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, COUGH (coughing - dry cough), ASTHENIA (weakness), FLUSHING (flushed a little bit), DECREASED APPETITE (Not hungry have not had dinner no breakfast, No appetite), DYSPHONIA (voice is deeper), HEADACHE (Headache) and FATIGUE (tiredness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  The patient received treatment with acetaminophen (Tylenol).
Pain in arm - arm red & swollen Chills, shivering for 10 hours Headache Very tired & weak 4 days later developed a fever blister & peeling skin in the mouth
The main side effect I wish to report is severe joint pain in both knees, lower back, and ankles.  Started around 3:00AM the night of the vaccine and lasted about 32 hours.  I also experienced severe headache, restlessness, a 100.4-101.0 F fever lasting about 16 hours from 3:00 am of the night of vaccine.    I did not take any medications.  Side effects resolved on their own.
normal fever; Fatigue; Muscle pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose number Unknown, Manufacturer Unknown), for Covid-19 Immunization. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "normal fever"; FATIGUE (non-serious), outcome "unknown", described as "Fatigue"; MYALGIA (non-serious), outcome "unknown", described as "Muscle pain".  Additional information: They received the Pfizer covid booster. Her son had the normal fever, fatigue, muscle pain the day after and so did her other half, her partner. She declined to complete a report on her son, stating he experienced the expected or normal symptoms. Stated her and her son had nothing, no arm pain.  The lot number for bnt162b2 was not provided and will be requested during follow up.
My husband came home from a trip feeling badly on February 19, 2023. In the morning he tested positive for COVID-19. I felt fine at the time but eventually began to develop some fatigue accompanied with sneezing and running nose. I took a COVID-19 test on February 24, 2023, and it was positive. I called my primary doctor, and she prescribed me Paxlovid. Starting on February 25, 2023, I took five days of Paxlovid with a great response and decrease in symptoms. A few days later, I developed significant upper respiratory symptoms with cough runny nose, and sinus pressure. I was sick for four or five more days. I couldn't sleep at night because I was coughing so hard, and my throat was so sore. I also had a headache. That gradually improved and then I had a negative test on March 15, 2023.  At that point, I was feeling well again.