chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Extreme fatigued; Swollen, swelling joints; extreme joint pain; Could not catch breathe had to sit down,; Numbness in Left arm and joints; Face broke out and skin went from dry to oily; Called in Sick; This is a spontaneous report from a contactable consumer. A 37-year-old non-pregnant female patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: eng205) via an unspecified route of administration in the left arm on 06Mar2021 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. The patient had a history of seasonal allergies and sensitive to medication in the past. The concomitant medication included RITUAL, MEGARED, RITUAL VITAMIN, Burpropion HCL 150 mg (MANUFACTURER UNKNOWN), MOVE FREE JOINT HEALTH, ALLERTEC, magnesium 400mg (MANUFACTURER UNKNOWN), VITAMIN E, EVENING PRIMROSE and IMMUNITY BOOST for an unknown indication. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 08Mar2021 (Within 72 hours), the patient experienced extreme fatigued, swollen, extreme joint pain, couldn't catch breathe had to sit down, called in sick, still struggling with swelling numbness in left arm and joints, face broke out and skin went from dry to oily. No therapeutic measures were taken for the reported events. The events had not resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of fatigue, joint swelling, joint pain, numbness, oily face, feeling sick and breathlessness were recovered with sequelae on an unknown date of Mar2021.   No follow-up attempts are needed. No further information is expected.
Patient received vaccines on 10/31 and mom notice on 11/1 that patient had redness and swelling on left lateral upper arm. Patient was seen by MD on 11/2 and MD prescribed Diphenhydramine 12.5 mg (Hcl 12.5 mg/5ml) every 6 hours as needed.
24 hours post injection patient had large area of erythema >10 cm around point of injection.
A report was received from a health care professional on 2/16/04 concerning a 1 year old female vaccinee who inadvertently received Fluvirin on 12/5/03. On 12/5/03, the vaccinee inadvertently received Fluvirin. At the time of the report no adverse events had been reported. There was insufficient information to determine the reporter's causality assessment. No follow up pending.
expired pentacel vaccine was administered,with no reported adverse event; Initial information received on 29-Mar-2023 regarding an unsolicited valid  non-serious case from other health professional.  This case is linked to case 2023SA102456.  This case involves a 4 months old male patient to whom expired diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)] was administered,with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included rotavirus vaccine pneumococcal vaccine CONJ 15V (CRM197) (vaxneuvance) and diphtheria vaccine toxoid, hepatitis B vaccine RHBSAG (YEAST), HIB vaccine CONJ (menigococcal protein), pertussis vaccine acellular 5-component, polio vaccine INACT 3V (VERO), tetanus vaccine toxoid (VAXELIS) all for Immunisation.  On 16-Mar-2023, the patient received suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine suspension for injection at a dose of 0.5 ml once (lot UJ651AAA, expiry date: 25-Feb-2023) via intramuscular route in the left thigh for immunization.  On 16-Mar-2023, expired pentacel vaccine was administered,with no reported adverse event (expired product administered, latency: same day).  It was reported that an expired PENTACEL vaccine was administered to 3 patients, she then after investigating stated it was only 2 patients.  Action taken: Not applicable.  Outcome: Unknown.   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.
1wk p/vvax pt had a fever of 104 lasting 2 1/2 days;rash & convuuls from the fever;tx was APAP every 2hr until fever borke;MD said they could do nothing for pt if it was from the MMR vax;
I received my second dose Wednesday (1/20/21) about 10:50. Within 90 minutes to two hours I developed a headache, metallic taste and dryness in my mouth, and mild nausea. Thursday 1/21/21 I came to work feeling tired, achy, sluggish and nausea, loss of appetite.  Later in the afternoon increasing tiredness, chills, and continued nausea. Moderna Covid-19 vaccine EUA I left early about 2:00.   That evening I developed a fever about 101.  Took some Tylenol.  Fever broke about 2am (1/22/21).  extensive sweating. Woke up feeling much better today.(1/22/21) Still not much of an appetite. A little shaky, mild chills/sweating.
From telephone call received on 07/03/02 from health care professional it was reported on that a 4 month old female infant was vaccinated on 06/24/02 with Tripedia lot #U0548BA, Prevnar lot #484237, IPOL lot #U0823 and ActHIB lot #UA710AA. That same day in the pt experienced seizure activity consisting of body tremors, head bobbing and tongue biting. The pt had an MRI and EEG done on 06/27/2002 and was evaluated by a neurologist on 06/28/2002. Child was not hospitalized. Seizures continue. No specific medical treatment was relayed by the reporter. *F/UP report on 10/29/02: F/UP #1 correspondence: PT is still having tremors and is being followed by a neurologist. The MRI exam of the brain revealed that there is a vague 4 mm focus of increased signal intensity on coronal T1-weighted sequence at the inferior aspect of the right basal ganglia. Follow-up MRI exam is suggested. The EEG results were abnormal due to some fairly persistent intermittent but frequently recurrent asymmetric slowing over the right hemisphere, maximal over the right occipital and right mid- and posterior temporal region. No definite epileptiform discharges were seen. Correlation with clinical data is indicated. Follow up on 08/22/2003: "Despite several attempts to obtain further information for this case, no further information has been received.  The case is considered closed." Follow up on 11/25/2003: "Patient is still having tremors and is being followed by a neurologist.  The MRI examination of the brain revealed that there is a vague 4mm focus of increased signal intensity on coronal T1-wighted sequence at the inferior aspect of the right basal ganglia.  No abnormality can be seen on other sequences, and the clinical significance of this finding is uncertain.  Follow-up MRI exam is suggested.  The EEG results were abnormal due to some fairly persistent intermittent but frequently recurrent asymmetric slowing over the right hemisphere, maximal over the right occipital and right mid and posterior temporal region.  No definite epileptiform discharges were seen.  Correlation with clinical data is indicated. "
This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (reaction from my Moderna vaccination) 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 VACCINATION COMPLICATION (reaction from my Moderna vaccination). At the time of the report, VACCINATION COMPLICATION (reaction from my Moderna vaccination) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.  No treatment medications were provided.
8/3 started feeling severe fatigue- rest and given pain medication 8/6 noticed fatigue and spots on chest and back- bath, rest, pain medication 8/8 More spots on chest and abdomen and back and pain in shoulder and back that ran down the back to hip. Restless/sleepless night with severe abdominal pain, nausea, and chills- pain and fever medication, bath, rest 8/9 Doctor visit with fatigue and trunk pain, sore muscles- legs, chest and hurt to take deep breaths. Shifted to bladder and discomfort sleeping
COVID positive on 11/9/2021. Admitting dx COVID 19 pneumonia.  This patient was admitted to the emergency room because of shortness of breath attributed to COVID-19 pneumonia infection.  The patient was put on oxygen per nasal titration.  The patient was doing fairly well on 3-4 L nasal cannula.  The patient was on 3 L, very comfortable, but he is feeling weak, unable to ambulate on his own. Cardiology, Pulmonary along with ID were involved in his care.  He had remdesivir treatment. He is agreeable to go to subacute rehab. Ultimately, he needs to go to subacute rehab to buy some time.  Hopefully, this can help him to get his strength and independence. The patient is clinically stable and will be discharged hopefully today to subacute rehab.
reported upper lip tingling & anxiety due to vaccinator asking and telling her about news / social media describing adverse events / deaths .  R/T Covid vaccines & relaying he/she didn't get & won't get vaccinated.  no other S/S;  lip is not swollen;  TX- support emotionally & issue taken to Medical Dr.
Allergic reaction; Rash over trunk area / Rash flare/broke into rashes; Broke into rashes and its itching; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash over trunk area / Rash flare/broke into rashes), RASH PRURITIC (Broke into rashes and its itching) and HYPERSENSITIVITY (Allergic reaction) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to animal (Takes Claritin for Cat allergy). Concomitant products included LORATADINE (CLARITINE ALLERGY) for Allergy to animal.    On 28-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2022, the patient experienced RASH (Rash over trunk area / Rash flare/broke into rashes) and RASH PRURITIC (Broke into rashes and its itching). On an unknown date, the patient experienced HYPERSENSITIVITY (Allergic reaction). At the time of the report, RASH (Rash over trunk area / Rash flare/broke into rashes), RASH PRURITIC (Broke into rashes and its itching) and HYPERSENSITIVITY (Allergic reaction) outcome was unknown.            Patient had no problems while breathing was reported. Treatment included: Montelukast and Benadryl for Allergic reaction.
Headache, Myalgia, Reports flu-like symptoms, headaches, body aches, swollen lymph nodes, chills, night sweats. Narrative:
suffered a TIA; This spontaneous case was reported by a consumer and describes the occurrence of TRANSIENT ISCHAEMIC ATTACK (suffered a TIA) in a female patient of an unknown age 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced TRANSIENT ISCHAEMIC ATTACK (suffered a TIA) (seriousness criterion medically significant). At the time of the report, TRANSIENT ISCHAEMIC ATTACK (suffered a TIA) outcome was unknown.            No concomitant medications were reported. No treatment medications were provided by the reporter.  Very limited information regarding the event has been provided at this time. No further information is expected.; Sender's Comments: Very limited information regarding the event has been provided at this time. No further information is expected.
Patient brought in by mom with 2 bumps on each anterior thigh for 6 weeks. Redness noted on day one of vaccine placement. Mom noticed bump on legs about 1-2 weeks after vaccines. Mom seen by PA on 8/24, bumps felt on anterior thigh; firm to touch. Advised mom to try heat and message to break up mass.
At 10 days, broke out with shingles.; This is a spontaneous report from a contactable consumer (patient himself). This consumer reported similar events for 2 patients. This is 1st of 2 reports.   A 70 years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EL3248; Expiration Date: unknown) via an unspecified route of administration, administered in Left arm on 13Jan2021 at 11:45 as single dose for COVID-19 immunization. Medical history included diabetes mellitus from an unknown date and unknown if ongoing. The patients known allergies was reported as none. Concomitant medication(s) included metformin (METFORMIN), lisinopril (LISINOPRIL), atorvastatin (ATORVASTATIN) and pantoprazole (PANTOPRAZOLE) taken for an unspecified indication. The patient was not diagnosed prior and since the vaccination with COVID-19. It was reported that, at 10 days, after the first dose on 23Jan2021 the patient was broke out with shingles and still was suffering. The adverse event started hurting 5days after first shot. Patient said there was delay in reporting this event because everything he had read, said there was no connection between the Civic shot and Shingles. He also started feeling bad 5 days after first shot and broke out with Shingles at 10 days. It was reported that the adverse event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Patient had not received any treatment for adverse event. The outcome of event was recovering.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021265135 same reporter/product/event, different patient
Per patient's husband, patient received her shot on 12/08/2021. On 12/10/2021, Friday, around 1AM, she felt excruciating nerve pain to the shoulder. She went to see the dr. on 12/13/2021 and got prescribed tramadol 50mg #24.
Patient presented to hospital on 4/9/21 - 4 days post vaccination - with new onset left sided weakness.  Brain CTA showed a M1 branch occlusion.  Patient was given TPA and transferred to Medical Center for further management and mechanical thrombectomy.   Successful thrombectomy done. Etiology of stroke cryptogenic but suspect emoblic event.  Questionable moyamoya disease - notes state "if moyamoya suspect, patietn will get neurosurgery survice on board/appreciate neuro recommendations"
Swelling, pain & erythema L/thigh. Pain & erythema resolved in 48 hrs; swelling persisted with 50% increase in size of thigh, still.
Hives in both arms 10 days after receiving the first dose; This spontaneous case was reported by a pharmacist and describes the occurrence of URTICARIA (Hives in both arms 10 days after receiving the first dose) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced URTICARIA (Hives in both arms 10 days after receiving the first dose). At the time of the report, URTICARIA (Hives in both arms 10 days after receiving the first dose) outcome was unknown.        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.   Concomitant medications were not reported  No treatment was specified
arm was just a little sore after first dose; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of MYALGIA (arm was just a little sore after first dose) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045ABIA) for COVID-19 vaccination.     Concomitant products included PARACETAMOL (TYLENOL) for Allergy.    On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Apr-2021, the patient experienced MYALGIA (arm was just a little sore after first dose). At the time of the report, MYALGIA (arm was just a little sore after first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient took medications for stroke as concomitant product. No Treatment were reported.
Presented with hemoptysis/dyspnea, fever, cough; CXR: bil pleural effusions TX: Lasix, Steroids, doxycycline, zinc,
Contracted COVID 19 on June 2nd, 2022. Not eligible for Paxlovid No monoclonal injecttion.
Received KINRIX and Flu vaccine to right thigh on 2/20/18. Parent states patient had tactile fever after vaccine but none noted the day of office visit. MD notes indicate "13x10 cm oval erythematous raised warm on dorsal aspect of right thigh, non-tender. Per Dr. when evaluated 2/22/18.
feeling lousy; cold; only got 2 hours of sleep; big lump 4 inches around the injection site; arm swelled to real hard knot, hot, red, itching, hurting,; arm swelled to real hard knot, hot, red, itching, hurting,; arm swelled to real hard knot, hot, red, itching, hurting,; arm swelled to real hard knot, hot, red, itching, hurting,; headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (feeling lousy), HEADACHE (headache), NASOPHARYNGITIS (cold), INSOMNIA (only got 2 hours of sleep) and INJECTION SITE SWELLING (arm swelled to real hard knot, hot, red, itching, hurting,) in a 76-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 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced VACCINATION COMPLICATION (feeling lousy), HEADACHE (headache), NASOPHARYNGITIS (cold), INSOMNIA (only got 2 hours of sleep), INJECTION SITE SWELLING (arm swelled to real hard knot, hot, red, itching, hurting,), INJECTION SITE WARMTH (arm swelled to real hard knot, hot, red, itching, hurting,), ERYTHEMA (arm swelled to real hard knot, hot, red, itching, hurting,), PRURITUS (arm swelled to real hard knot, hot, red, itching, hurting,) and INJECTION SITE MASS (big lump 4 inches around the injection site). At the time of the report, VACCINATION COMPLICATION (feeling lousy), HEADACHE (headache), NASOPHARYNGITIS (cold), INSOMNIA (only got 2 hours of sleep), INJECTION SITE SWELLING (arm swelled to real hard knot, hot, red, itching, hurting,), INJECTION SITE WARMTH (arm swelled to real hard knot, hot, red, itching, hurting,), ERYTHEMA (arm swelled to real hard knot, hot, red, itching, hurting,), PRURITUS (arm swelled to real hard knot, hot, red, itching, hurting,) and INJECTION SITE MASS (big lump 4 inches around the injection site) outcome was unknown.            No concomitant medication were provided.  Treatment medication included lidocaine salve ,ice pack for her arm, Tylenol.   This case was linked to MOD-2021-036516, MOD-2021-036516 (Patient Link).
Beginning around  3 AM on 4-11-21 experienced extensive joint pain throughout entire body, and beginning at 10 AM and continuing on, experienced significant nausea.
Patient intially stated that "everything is bright" and felt hot and then cold. He also c/o "tightness" of the left chest and shoulder without radiation down the arm or to the neck. HR 88, heart normal S1, S2 no m/g/r, lungs clear to ausculation with normal respiration effort and rate, radial pulse 2+ b/l. + focal tenderness to palpation of the left chest wall at rib 3 costochondral junction and also more laterally (patient stated he was lifting heavy equipment earlier in the day). No pressure, no dizziness or syncope, no sweating. Patient rested and given water to drink. Symptoms of brightness and hot/cold resolved. After 40 minutes patient still c/o feeling of tightness in chest - not worse but still present, no change in physical exam. Patient to go by private car to ED for further evaluation but not driving himself. He left vaccination room with site manager who was to assist him with a ride, wife was on way to the site. Instructed that if pain significantly worsened or he developed any SOB in the meatime that ambulance should be called.
Significant loss of energy; Sleepiness; Recurrent falls; Losing his balance; After falling he was unable to pick himself up and even with assistance had issues; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Significant loss of energy), SOMNOLENCE (Sleepiness), FALL (Recurrent falls), BALANCE DISORDER (Losing his balance) and GAIT INABILITY (After falling he was unable to pick himself up and even with assistance had issues) in a 79-year-old male patient 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ASTHENIA (Significant loss of energy), SOMNOLENCE (Sleepiness), FALL (Recurrent falls), BALANCE DISORDER (Losing his balance) and GAIT INABILITY (After falling he was unable to pick himself up and even with assistance had issues). At the time of the report, ASTHENIA (Significant loss of energy), SOMNOLENCE (Sleepiness), FALL (Recurrent falls), BALANCE DISORDER (Losing his balance) and GAIT INABILITY (After falling he was unable to pick himself up and even with assistance had issues) outcome was unknown.            No concomitant medication was provided.  It was reported that the feet did not seems to listen to his head and it was lucid and responsive throughout.    No treatment medication was provided.   This case was linked to MOD-2022-549155, MOD-2022-549165, MOD-2022-549166 (Patient Link).
Joint pain, widespread muscle pain, headache, fatigue; onset 5 hours after injection; ibuprofen for headache and pain; 24 hours after injection symptoms improving.
Pfizer COVID vaccines on 2/8/2021 and 3/1/2021 Hospitalized on 10/12/2021 at hospital Diagnosis of epileptic seizure, COVID 19, Cardiac arrest, elevated tropinin, and otitis media Treatment included, Augmentin, Topamax 50 mg twice daily, and cardiology consult Additional Pfizer booster received on 11/18/2021 after the adverse event on 10/12/2021
Information has been received from a pharmacist concerning an unspecified patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies, concurrent conditions and concomitant therapies were not informed. On 31-JAN-2017, the patient was inadvertently vaccinated with an expired dose of ZOSTAVAX lot # L040442, expiration date 31-JAN-2017, (dosage and therapy route were not provided), for prophylaxis. The reporter was not aware of any adverse effect. Additional information has been requested.
SIDS, ? Mom rolled over on baby but not confirmed according to MD. Autopsy report received 11/30/2006 confirms SIDS/sr