chrisvoncsefalvay/vaers-outcomes huggingface dataset:
got very ill after vaccination; brain fog; hot flash/ sweats/ feeling hot; Feeling hot; hot flush; Headache; body ache; Tired; Nauseas; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (got very ill after vaccination), FEELING ABNORMAL (brain fog), HYPERHIDROSIS (hot flash/ sweats/ feeling hot), FEELING HOT (Feeling hot) and HOT FLUSH (hot flush) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048CZ1A and 048CZ1A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included CARBIDOPA, LEVODOPA (LEVODOPA/CARBIDOPA), ASPIRIN [ACETYLSALICYLIC ACID], AMLODIPINE, ONDANSETRON and TESTOSTERONE for an unknown indication.   On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Jun-2021, the patient experienced FEELING ABNORMAL (brain fog), HYPERHIDROSIS (hot flash/ sweats/ feeling hot), FEELING HOT (Feeling hot), HOT FLUSH (hot flush), HEADACHE (Headache), MYALGIA (body ache), FATIGUE (Tired) and NAUSEA (Nauseas). On an unknown date, the patient experienced VACCINATION COMPLICATION (got very ill after vaccination). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form. At the time of the report, VACCINATION COMPLICATION (got very ill after vaccination), FEELING ABNORMAL (brain fog), HYPERHIDROSIS (hot flash/ sweats/ feeling hot), FEELING HOT (Feeling hot), HOT FLUSH (hot flush), HEADACHE (Headache), MYALGIA (body ache), FATIGUE (Tired) and NAUSEA (Nauseas) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Historical condition include the tendency to dry out due to Hypomcigremia. Concomitant product used acid reflux medication.   This case was linked to MOD-2021-110171 (Patient Link).
Patient received Smallpox vaccination on 7July2005. And 3 weeks later started developing Guttate psoriasis. Has had guttate psoriasis for 7 months as of now.
After the initial injection site pain, I have experienced constant intramuscular pain at the site and adjacent areas in the muscle upon movement or use. Something as simple as flexion or extension causes a sharp pain in that area. I initially put that off to the trauma of the injection itself, but now four months later with no improvement, I can only conclude that the injection caused more than normal injection trauma. I am also experiencing numbness and tingling in the whole arm after periods of immobility (such as sleeping). Getting up in the morning, that arm is moderately sore, and I experience particular pain around the injection site. There has been no injury to that arm or that muscle group. I have no pre-existing injuries or conditions that would have a bearing on this pain. I have not sought medical attention, as I feel certain that there is not enough known about this vaccine to reliably come up with a treatment plan.
This case was reported by a nurse via sales rep and described the occurrence of injection site burning in an unspecified number patients who received FLULAVAL QUADRIVALENT. On an unknown date, the patient received FLULAVAL QUADRIVALENT at an unknown dose. On an unknown date, immediately after receiving FLULAVAL QUADRIVALENT, the patient experienced injection site burning. On an unknown date, the outcome of the injection site burning was unknown. It was unknown if the reporter considered the injection site burning to be related to FLULAVAL QUADRIVALENT.  Additional details were provided as follows: The nurse told GlaxoSmithKline representative that several of their patients experienced injection site burning at the moment of injection with the FLULAVAL. Initial reporter did not provide any specifics on the patients.
1st Pfizer vaccine dose on 22Jan2021. 2nd Pfizer vaccine dose on 15Feb2021; 1st Pfizer vaccine dose on 22Jan2021. 2nd Pfizer vaccine dose on 15Feb2021; eye lids are very puffy/puffy eye lids; Lightheadedness; feeling dizzy/Dizziness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. Other Case identifier(s): US-PFIZER INC-2021285051 (Pfizer).  A 83 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 15Feb2021 10:00 (Lot number: SC9262) at the age of 83 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Type 2 diabetes mellitus" (ongoing); "Defibrillator/pacemaker insertion", start date: 2015 (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Bnt162b2 (Lot: EL8982. It was administered in his left arm.), administration date: 21Jan2021, when the patient was 83 years old, for Covid-19 immunisation, reaction(s): "atrial fibrillation", "cardiac arrhythmia", "dizzy", "light headedness", "shortness of breath". The following information was reported: OFF LABEL USE (non-serious), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious), outcome "unknown" and all described as "1st Pfizer vaccine dose on 22Jan2021. 2nd Pfizer vaccine dose on 15Feb2021"; DIZZINESS (non-serious) with onset 18Feb2021, outcome "recovering", described as "feeling dizzy/Dizziness"; EYELID IRRITATION (non-serious) with onset 05Mar2021, outcome "not recovered", described as "eye lids are very puffy/puffy eye lids"; DIZZINESS (non-serious) with onset 18Feb2021, outcome "recovering", described as "Lightheadedness". The events "feeling dizzy/dizziness", "eye lids are very puffy/puffy eye lids" and "lightheadedness" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible. No further information is expected.
Slumped over desk, slow response to verbal stimuli, weak pulse reported. When I arrived few minutes later patient was responsive, strong regular pulse of 90, was speaking coherently but stated did not feel right. EMS transported patient to hospital.
Headache; nausea; tiredness; joint pain; This spontaneous case was reported by a patient and describes the occurrence of HEADACHE (Headache), NAUSEA (nausea), FATIGUE (tiredness) and ARTHRALGIA (joint pain) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     Concomitant products included TRAMADOL for Pain.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headache), NAUSEA (nausea), FATIGUE (tiredness) and ARTHRALGIA (joint pain). At the time of the report, HEADACHE (Headache), NAUSEA (nausea), FATIGUE (tiredness) and ARTHRALGIA (joint pain) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information not provided.
Fever; This is a spontaneous report from a contactable consumer (patient's mother). This consumer reported similar event for herself and 3 patients. This is the second of four reports. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date as unknown dose, single, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced fever on an unspecified date. The outcome of the event fever was unknown.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021564496 Same reporter/drug/event, different patient;US-PFIZER INC-2021565268 Same reporter/drug/event, different patient;US-PFIZER INC-2021566846 same reporter/drug/event; different patient
Nausea, fatigue, extreme arm pain, armpit lymph node pain, light headedness
Breathlessness; Legs numb; Anxiety; This is a spontaneous report from a contactable consumer. A 50-year-old female patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: ER8734), via an unspecified route of administration, administered in Arm Left on 08Apr2021 14:15 as DOSE 1, SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On Apr2021, after first shot 1 week later breathless ness and legs numb and went to ER. Thought it just an anxiety. Only after second shot realized more issues. Case was assessed as non-serious. There was no seriousness criteria-Results in death, Life threatening, Caused/prolonged hospitalization, Disabling/Incapacitating, Congenital anomaly/birth defect. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination and Since the vaccination, was the patient did not diagnose with COVID-19. The outcome of the events was unknown.    Follow-Up (29Jun2021): Follow-up attempts are completed. No further information is expected.
Patient hospitalized for   SBO (small bowel obstruction) ,   Acute renal failure (ARF)  within 6 weeks of receiving covid vaccination.
Patient is fully vaccinated and boosted 10/8/2021.  COVID + 1/14/2022.  61-year-old with no significant past medical history, presented due to complaint of passing out; she states she was diagnosed with COVID last Friday, has been having some shortness of breath.  She notes that she went down to the bathroom to take shower and next thing she remembered was being in the hospital and getting CAT scan, she cannot recall any other symptoms, denies any seizure-like activity, has not taken any antibiotics for her COVID.  Today, denies any chest pain. CT head/cervical spine has been reviewed, negative for any acute findings.MRI Reviewed;  Mild burden of nonspecific subcortical and periventricular white matter signal changes which could be on the basis of small vessel ischemic changes with demyelination, chronic migraines, and vasculitis also in the differential. Discharged home.
Wrong combo vaccine was given to patient, Kinrix is only approved for ages 4 through 6 years. no signs or symptoms have been reported.
I started having chills and a fever and went to bed. I woke up the next morning brushed my teeth and i passed out and hit my head and was dehydrated. I stayed in the ER for about 5 hours.
Body aches, loopiness, visual hallucination. The hallucination occurred around 10 hrs after the vaccination was administered while patient sat in a dark room. Patient (age 13) has a history of audio hallucinations, but no visual ones
This was second shot of series. I had initial soreness at vaccination point, but 3/4 days later I had neck pains which I understand in reading is associated with lymph gland response - these neck pains lasted 3/4 days. Then subsequently had minor headaches, which unusual as I do not typically suffer - the headaches have now gone.  To add, I had minor aches on my first shot, nothing more and lasted only few days  I am flagging circumstances given the delayed reaction maybe of interest for your records.
This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not reported. No previous drug reactions or allergies were reported. On an unknown date the patient was vaccinated with improperly stored Oral, ROTATEQ (strength, dose, frequency and route were not reported) lot # K011947 with an expiry date of 06-JUL-2016. No concomitant medications were reported. No adverse effects were reported. There was no product quality complaint. This is one of the several reports received from the same reporter. Additional information has been requested.
dizziness BP: 142/78  Pulse: 72     P.T.O.   patient advised to stay for extra 15 mins. observation  - advised to drink more fluids -vitals after 15 mins.  BP: 126/72 Pulse-72  Patient feels better and left for home
Developed local reaction - redness at injection site after vaccine 1st 24 hr then had increased redness and swelling rt leg at injection site next day. Seen at office and treatment with antibiotic given. 12-5-13.
After been injected I had redness and swelling at the injection site.  Next day I ad fever, chills, myalgia, headache, fatigue and local pain.  I had to take a sick day form work because I was not able to get out of bed.
PATIENT STARTED HAVING PAIN (SORENESS, BRUISE-LIKE FEELING) AFTER ADMINISTRATION OF PNEUMOVAX - 23 ON 08/16/2020. PATIENT CAME BACK 09/11/2020 AND REPORTED STILL HAVING PAIN ON RIGHT ARM (RADIATING ABOUT 2 INCHES FROM INJECTION SITE). ALSO A SMALL RAISED BROWN SPOT IS PRESENT AT INJECTION SITE, NO SWELLING, NO REDNESS AND NOT WARM TO TOUCH. PATIENT WAS ADVISED TO APPLY COLD COMPRESS TO AREA TO ALLEVIATE NERVE PAIN IF POSSIBLE. ON 09/16/2020 PATIENT REPORTED WORSENING PAIN, CAN NOT RAISE ARM ABOVE SHOULDER.
Body aches, chills, temp 100.6 in clinic. Sent home from work for 48 hours. Otherwise benign exam.
Fluzone High-Dose administered that had undergone delayed shipping transit/No AE; Initial information received on 01-Nov-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case is linked to cases 2019SA307301, 2019SA307319, 2019SA307320 and 2019SA307321 (same reporter).  This case involves a 82 years old female patient who received  0.5 ml dose vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] lot UJ290AB and expiry date:09-Jun-2020 intramuscular in the left deltoid, On an 31-Oct-2019, Which had undergone delayed transit during shipping.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of actual medication error due to incorrect product storage.  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Vesicular rash appeared on chest, stomach, back and face 11/15/04.
pt presented to the ER on 01-24-2022 with c/os of SOB, productive cough, and fever. pt had received COVID booster vaccine on 01-21-22. according to pt chart. all symptoms started on day of presentation. pt was tested and COVID-19 positive. pt was admitted to this hospital for COVID-19 PNA and COPD. pt was discharged from this hospital on 01-26-2022. pt returned to this hospital on 01-27-2022 via EMS per pt family's request for cont SOB, weakness, fever, and irregular heart rate.
Patient came into the pharmacy for the Johnson and Johnson covid-19 vaccine. Patient filled out the registration and consent form. This form has a question asking if the patient has received any of the covid-19 vaccines to date. The patient checked "no." After the clinic the vaccinator (RN) went to document vaccination in system and noticed that the patient has a documented vaccination of Moderna from the health department 4 days prior to receiving the Johnson and Johnson vaccine. Pharmacy unable to reach patient at provided phone number.
Pt received Moderna COVID-19 Vaccine Dose 1 at 0837. At 0843 pt started to complain of numbness and tingling in bilateral hands, right worse than left. Shaky feeling. Lightheadedness. Slight nausea. No dyspnea or numbness/tingling in face, neck, or throat. HR: 84 BP: 147/78 SP02: 95%-96%. At 0845, pt given apple juice and saltine crackers. Cool rags applied to neck. Stayed in room with pt to monitor. At 0900 pt laying back in chair, states she is feeling a bit better. HR: 74 BP: 128/73 SP02: 99%. At 0910, pt states that she is starting to feel like her throat is swelling and Convenient Care staff present by 0911. At 0913, pt was taken over to Convenient Care via wheelchair.  At convenient care, pt presented with possible allergic reaction where she reported an allergy to peanuts and that she "has had reactions to other things". She had an injection site reaction to her first influenza vaccine (unknown year), but now receives them annually without issue. Pt reports she feels her hands are swelling, as her rings feel tight and that is not usually the case. Pt given diphenhydramine 50 mg IM x 1 and BP improved from 175/84 to 154/90. At 0940, pt reported she felt the lump in her throat was better and the rings on her fingers are looser. Pt spent about 1 hour at convenient care before pt was discharged to home. Pt diagnosed with allergic reaction to COVID-19 vaccine.
Initial pregnancy report received from a healthcare professional on 04 April 2013. A 29-year-old female patient, whose medical history and concomitant medications were not reported, has received intramuscular first dose of ADACEL lot number: U4612AA (Anatomical site of vaccination was not reported) on 04 April 2013. The patient was pregnant during vaccination. The patient's last menstrual period was reported as 16 August 2012 and the expected date of delivery is 31 May 2013. As per reporter the patient did not experienced any adverse event. List of documents held by sender none.
Nausea- morning x2; diarrhea- morning x2; vomiting- morning x2.
PATIENT SHOWED UP TODAY FOR HIS SECOND PFIZER DOSE AND UPON LOOKING AT IMMPACT REGISTRY, I SAW THAT HE HAD PREVIOUSLY RECEIVED 2 DOSES OF THE MODERNA VACCINE IN APRIL AND MAY 2021
The second dose hit me much harder. Within 4 hours I was experiencing a low-grade fever of 100.4 degrees. Six hours after the shot I began feeling nauseous and tired. I also developed a large red circle was around the shot site on my right arm and a prominent bulge. Overnight, despite exhaustion, I experienced a fever and chills. The next day (around 24 hours after the shot) I was exhausted and very nauseous. I did not get out of bed and slept on and off for 8 hours. The red and swollen area around the shot site went down around day three. It has now been 5 days after the second dose and I am still experiencing fatigue and nausea.
The vial was stored in the refrigerator on 04-JUN-2023 after expiration date 30-MAY-2023; She states that no adverse reactions have been reported by any patients; Doses to patients on 5JUN2023 from vials of the Moderna COVID-19 bivalent vaccine that had expired; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses to patients on 5JUN2023 from vials of the Moderna COVID-19 bivalent vaccine that had expired), PRODUCT STORAGE ERROR (The vial was stored in the refrigerator on 04-JUN-2023 after expiration date 30-MAY-2023) and NO ADVERSE EVENT (She states that no adverse reactions have been reported by any patients) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 019H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 05-Jun-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 05-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses to patients on 5JUN2023 from vials of the Moderna COVID-19 bivalent vaccine that had expired). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was stored in the refrigerator on 04-JUN-2023 after expiration date 30-MAY-2023) and NO ADVERSE EVENT (She states that no adverse reactions have been reported by any patients). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses to patients on 5JUN2023 from vials of the Moderna COVID-19 bivalent vaccine that had expired), PRODUCT STORAGE ERROR (The vial was stored in the refrigerator on 04-JUN-2023 after expiration date 30-MAY-2023) and NO ADVERSE EVENT (She states that no adverse reactions have been reported by any patients) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (She states that no adverse reactions have been reported by any patients) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Doses to patients on 5JUN2023 from vials of the Moderna COVID-19 bivalent vaccine that had expired) and PRODUCT STORAGE ERROR (The vial was stored in the refrigerator on 04-JUN-2023 after expiration date 30-MAY-2023).    Concomitant medications were not reported.  Suspect product dosage text was reported as unknown. It was reported that no adverse reactions have been reported by any patients. The vial was initially stored in the refrigerator on 4-JUN-2023 and did not underwent any temperature excursions.  Treatment information was not reported.  This case is reported for patient 47 out of 50 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-735331 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-735331:Master case
This spontaneous case reported by a consumer, describes the occurrence of rash (on stomach) and swelling (bumps) in a 21-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 046B217) for COVID-19 immunization. No medical history reported. On Apr 12, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Apr 12, 2021, patient experienced rash (on stomach). On an unknown date, patient experienced swelling (bumps). The patient treated with hydrocortisone for rash, at an unspecified dose and frequency. At the time of the report, rash (on stomach) and swelling (bumps) outcome: unknown/not provided. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown.
Patient Stated on 5/14/2019 that "I've been having itchiness around shoulder, chest and back in conjunction with a pins and needles sensation in my right arm after Anthrax vaccine."
Temp - 99.7, pulse 105-120 dizzy, pain to (L) deltoid, arm treatment: rest, TYLENOL.
pruritic; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (pruritic) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     The patient's past medical history included No adverse event.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRURITUS (pruritic). At the time of the report, PRURITUS (pruritic) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       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.   Reporter did not allow further contact; Sender's Comments: 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.
Delayed reaction, sore, indurated, red arm, hot to the touch, around injection site
Rag on arm for the first day. Rash and hives on chest and neck continued until 01/18/22.  Itchy eyes, ears, and throat still continuing.