chrisvoncsefalvay/vaers-outcomes huggingface dataset:
vertigo; palpitations; sick; This spontaneous case was reported by a patient family member or friend and describes the occurrence of VERTIGO (vertigo), PALPITATIONS (palpitations) and ILLNESS (sick) in an elderly male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, 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 an unknown date, the patient experienced VERTIGO (vertigo), PALPITATIONS (palpitations) and ILLNESS (sick). At the time of the report, VERTIGO (vertigo), PALPITATIONS (palpitations) and ILLNESS (sick) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.   It was unknown if patient had received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  The reporter reported that her husband ended up with vertigo and heart palpitations. They were in the hospital. He got sick.  No treatment medications were reported.
Got the does on the 6th of January around 3:00pm Around 9a  on the 7th  my skin started to hurt  then about about 9:00PM  I developed chills  Around 2 am  the next day I woke up really hot also with chills  5AM 8th I noticed   a 10cm soft lump on the left arm pit  22nd  Completely resolved
Sore arm (lasted approximately 24 hours); chills (lasted approximately 3 hours)
This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4220167-00 (RA). A 62 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 11Mar2021 (Batch/Lot number: unknown) at the age of 61 years as dose 1, single, intramuscular, administration date 01Apr2021 (Batch/Lot number: unknown) as dose 2, single and intramuscular, administration date 19Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation; Risankizumab (SKYRIZI [RISANKIZUMAB]), subcutaneous (Batch/Lot number: unknown) for psoriasis; metformin (METFORMIN) (Batch/Lot number: unknown). The patient's relevant medical history was not reported. Concomitant medication(s) included: COSENTYX; FLU, administration date 2021. The following information was reported: PRECANCEROUS CONDITION (medically significant), outcome "recovering", described as "precancerous lesion on arm/skin precancer spots/pre skin cancer"; DIABETES MELLITUS (medically significant), outcome "unknown", described as "Diabetes"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Pain in arm"; SKIN INDURATION (non-serious), outcome "unknown", described as "Skin induration"; SKIN DISORDER (non-serious), outcome "unknown", described as "Skin disorder"; SKIN HYPERPIGMENTATION (non-serious), outcome "unknown", described as "hyperpigmentation lighter"; EPISTAXIS (non-serious), outcome "unknown", described as "Nosebleed"; NASAL MUCOSAL DISORDER (non-serious), outcome "unknown", described as "some mucous problems"; NASAL DRYNESS (non-serious), outcome "unknown", described as "Nasal dryness"; NEEDLE TRACK MARKS (non-serious), outcome "unknown", described as "needle track marks"; INJECTION SITE SWELLING (non-serious), outcome "unknown", described as "injection site swelling"; PAIN (non-serious), outcome "unknown", described as "Stinging"; IMMUNE SYSTEM DISORDER (non-serious), outcome "unknown", described as "Immune system disorder"; PIGMENTATION DISORDER (non-serious), outcome "unknown", described as "pigmentation skin"; SKIN DISCOLOURATION (non-serious), outcome "unknown", described as "Skin discolouration"; SKIN DISORDER (non-serious), outcome "unknown", described as "skin disorder"; ASTHENIA (non-serious), outcome "unknown", described as "Energy decreased"; DIARRHOEA (non-serious), outcome "unknown", described as "Diarrhea". The patient underwent the following laboratory tests and procedures: biopsy skin: precancer spots. The action taken for Risankizumab and Metformin was unknown. The reporter's assessment of the causal relationship of the event with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Sender's Comments: Based on information provided and temporal association, causal relationship between the reported events and the suspect BNT162B2 cannot be excluded.
Site: (L) arm upper & lower shot given Tdap left upper arm MENACTRA (L) lower arm - redness/swollen. Localized reaction.
Administered immunizations 4/5/04. Received call from coroner's office stating child expired 4/6/04. No other information available.  Nurse follow up on 06/14/04 states: "acute pulmonary congestion;  acute pulmonary edema."
she feels kind of weak, like I just want to lie down; she has "not [been] feeling well"; headaches; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 48 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 15Apr2021 10:30 (Lot number: EW0164) at the age of 48 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: MALAISE (non-serious) with onset 16Apr2021, outcome "not recovered", described as "she has "not [been] feeling well""; HEADACHE (non-serious) with onset 15Apr2021, outcome "not recovered", described as "headaches"; ASTHENIA (non-serious), outcome "unknown", described as "she feels kind of weak, like I just want to lie down". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Reported as, after having first Pfizer covid vaccination yesterday and had not been feeling well. She has a headache. Patient states she feels kind of weak, like she just want to lie down. She had a mammogram before the vaccine. She did not treat her symptoms. No history of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available). There was no additional administered Vaccines. She explained after vaccination, she has "not [been] feeling well" and has "headaches". She mentioned she is someone who also gets "headaches once in a while". She asked if medication such as Tylenol can be taken after vaccination, for her symptoms.  No follow-up attempts are possible. No further information is expected.
MD told him, he has a slight irritation; Started with sinus infection symptoms ,did not specify, any symptom in particular; This spontaneous case was reported by a consumer and describes the occurrence of SINUSITIS (Started with sinus infection symptoms ,did not specify, any symptom in particular) and NASAL DISCOMFORT (MD told him, he has a slight irritation) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high and High cholesterol.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, the patient experienced SINUSITIS (Started with sinus infection symptoms ,did not specify, any symptom in particular). On an unknown date, the patient experienced NASAL DISCOMFORT (MD told him, he has a slight irritation). At the time of the report, SINUSITIS (Started with sinus infection symptoms ,did not specify, any symptom in particular) and NASAL DISCOMFORT (MD told him, he has a slight irritation) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications included Blood Pressure medication and cholesterol medication. Treatment details included patient was prescribed with azithromycin tablets, but has not taken any pills yet.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32-year-old female patient received BNT162b2 (BNT162B2), in Jan2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 30 years for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Yes" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Indication: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Local reaction redness, swelling, heat at injection site of 11cm. Patients left arm circumference is 3cm larger than the right arm and the patient is right handed. 12% increase from sIte swelling.
Heart rate from 80 BPM to 128 BPM in 30 mins. and remained > 105 for 16 hours. Headache, Nausea with Vomiting, Shortness of breath. Chills No fever
patient received an expired dose; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received an expired dose) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008C21A., 030M20A and 004M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received an expired dose). On 14-Oct-2021, EXPIRED PRODUCT ADMINISTERED (patient received an expired dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information were reported. No concomitant medications were reported.
Right leg numb and tingling for 3 days, headache for 1 week, stomach ache, joint pain.
Patient received first dose of Moderna.  Patient was administered Pfizer vaccination for second dose in error.  No adverse reactions noted.
This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (Severe allergic reaction/allergies), SEASONAL ALLERGY (seasonal allergies), EYE SWELLING (eyes are swollen) and PRURITUS (itchy) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination. The patient had not had seasonal allergies before receiving the Moderna vaccine. On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, the patient experienced HYPERSENSITIVITY (Severe allergic reaction/allergies), SEASONAL ALLERGY (seasonal allergies), EYE SWELLING (eyes are swollen) and PRURITUS (itchy). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) for Allergy, at an unspecified dose and frequency; FEXOFENADINE HYDROCHLORIDE (ALLEGRA ALLERGY) for Allergy, at an unspecified dose and frequency; OXYMETAZOLINE HYDROCHLORIDE (CLARITIN ALLERGIC) for Allergy, at an unspecified dose and frequency and LEVOCETIRIZINE DIHYDROCHLORIDE (XYZAL) for Allergy, at an unspecified dose and frequency. At the time of the report, HYPERSENSITIVITY (Severe allergic reaction/allergies), EYE SWELLING (eyes are swollen) and PRURITUS (itchy) outcome was unknown and SEASONAL ALLERGY (seasonal allergies) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medication information was provided. The allergy like symptoms went away during the summer, but had came back this spring. He did not had seasonal allergies before receiving the Moderna vaccine. This case was linked to MOD-2022-571957 (Patient Link).
Moderna booster vaccine with positive covid-19 almost kill me. On December 3, 2021 my husband did CPR  on me, because my heart stopped. The heart stopped several times in the hospital as well. I was hospitalized in local Hospital and alternate Hospital for one week. It is a long story. I didn't know I had covid-19, because I felt fine, no symptoms and I did the Moderna booster vaccine on Wednesday, December 1, 2021.My husband also had covid so he stayed at home. On December 3, 2021, if not for the help of my husband and his cardiopulmonary resuscitation, I would be dead by now. I'm very angry. Why didn't they warn people to check themselves before the vaccine booster that they don't have covid ? Why ?Nowhere.I was sick over a year. I wouldn't go if I knew I had covid.  Did Moderna Company announce and where for people to check if they have covid before taking booster vaccine? That they do covid tests. I felt fine no symptoms and had covid and took booster vaccine and I was fighting for my life.
Hives broke out within 4 hours post shot; large itchy red bumps that moved to different areas of the body for the duration of 5 weeks.
Tingling both legs and arms with weakness. Muscle weakness (not working right in func). Speech impairment.  4/20/09 Received hospital & rehab medical records (referred to but not included 12/31/2008-1/14/2009), 1/14-1/22/09,  1/22-2/3/09 & 2/3-2/14/2009. FINAL DX: Guillain-Barre syndrome Records reveal patient experienced LE weakness/numbness/tingling & inability to lift legs which had been preceded by possible viral illness.  Tx w/IVIG.  Improved slightly & admitted to inpatient rehab 1/14-1/22/2009.  While in rehab, noted to have worsening facial weakness & dysphagia & was readmitted to hospital 1/22-2/3/2009 for plasma exchange x 5.   Minimally improved & d/c to inpatient rehab 2/3-2/14/2009 where he improved considerably although unable to fully close both eyelids.  D/C home using walker & referred to outpatient PT & ST . Follow-up: Has mild residual weakness.
No adverse effect, patient is 17 years of age received 1st dose of moderna lot # 025B21A on 4/1/21, then 2nd dose on 4/29/21. 2nd dose given off-label. Patient's parent gave consent with wife on phone. Parents reported no adverse effect from  1st dose given 4/1/21.
Child received first ever flu vaccine and aobut 24 hours later developed tactile fever, warm with vomiting 4 episodes over 10 hour period. Some of these episodes provoked by meals.
Patient fainted in parking lot. Cut on chin, bruise on forehead, bloody nose, chipped tooth.
Fever up to 104.6F.  Extreme fatigue.  Random occasional shooting pain in various parts of the body.  General aches and pains.  Pain and swelling at the injection site.  Continued excessive sweating (night and day sweats).   Tenderness on scalp.
Tinnitus ( ringing in ear) in left ear increased in volume 9 hours after vaccination - is continuing now History of tinnitus for about two years
pt recvd vax; w/in 3 hrs pt states abdo became distended; n; ha, felt "like sand trickling thru eyes",lasted for 24 hrs;
This is a literature report for the following literature source: "Graded Administration of Second Dose of Moderna and Pfizer-BioNTech COVID-19 mRNA Vaccines in Patients with Hypersensitivity to First Dose", 2021; Vol:8 (12), DOI:10.1093/OFID/ofab507. The authors report a case series of outpatients from January to May 2021 for evaluation of symptoms consistent with immediate hypersensitivity reactions to the first dose of the Pfizer-BioNTech Covid-19 vaccine. A 63-year-old female patient received bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, solution for injection) administration date 2021 (lot number unknown) at the age of 63-years as dose 1, single for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The patient has no atopic history. The following information was reported: TYPE I HYPERSENSITIVITY (medically significant) with onset 2021, outcome "unknown", described as "immediate hypersensitivity reactions", time onset of event reported as 40 minutes; URTICARIA (medically significant) with onset 2021, outcome "unknown", described as "urticaria", time onset of event reported as 40 minutes. The patient underwent the following laboratory tests and procedures: serum S IgG titer, log 2 dilution: (2021) 17.35; skin test: (2021) unknown results, notes: positive skin test component was none. Therapeutic measures were not taken as a result of type I hypersensitivity, urticaria. Emergency department evaluation was not required. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Sender's Comments: Based on a drug event temporal association and on the compatibility with the known adverse event profile of the suspect product, the company cannot completely exclude a reasonable possibility that the suspect COVID-19 VACCINE may have contributed to the onset of reported events. Linked Report(s): US-PFIZER INC-202200151789 Same article/drug and different patient/event.
3 hours, post vax, the pt had a fever that climbed to 103F-104F despite treatment with both Tylenol and Motrin which lasted about 12 hours.
Baby developed petechial appearing rash on arms, legs, and trunk.  He also had large bruise at site of injection. A few days after developing the rash, he had multiple eye rolling upward episodes that appeared to be seizures. An ambulatory (approximately one hour) EEG was performed and was normal. He will be seeing an opthamologist as well.  Currently work-up is in progess.
He had a recent bout of chest pain (like a ligament tear, worse with lying down x 2 days)- which he dates to end of March/early April; he didn't seek care right away. He subsequently mentioned the episode to EP and was diagnosed with pericarditis with moderate pericardial effusion on 4/8/21. CRP 77. No viral symptoms. He received the Covid vaccine 2/12 and 3/12. Repeat echocardiogram on 5/3 showed resolution of pericardial effusion. He was prescribed colchicine but told to stop it after the echo showed resolution.   He also had a stress SPECT which showed normal perfusion but severe calcification of LM and LAD. He has no symptoms of chest pain. Pericarditic chest pain completely resolved. LDL was 110 and atorvastatin was increased from 60mg to 80mg 2 months ago.    He has no chest pain or shortness of breath. Takes lasix for LE edema. Very active. Walked 5 miles yesterday without issues. Occasionally gets short of breath climbing stairs.
Shoulder is extremely sore; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Shoulder is extremely sore) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Rotator cuff injury.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced ARTHRALGIA (Shoulder is extremely sore). The patient was treated with IBUPROFEN for Shoulder soreness, at an unspecified dose and frequency. At the time of the report, ARTHRALGIA (Shoulder is extremely sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.
ACHES; CHILLS; FATIGUE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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 not reported, batch number: Unknown) 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 subject experienced aches, felt like kicked my ass, chills, and fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, aches, fatigue and felt like kicked my ass was not reported. This report was non-serious.
Pain in their arm; felt tired, stayed in bed all day.; headache; nausea; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in their arm), FATIGUE (felt tired, stayed in bed all day.), HEADACHE (headache) and NAUSEA (nausea) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, the patient experienced PAIN IN EXTREMITY (Pain in their arm), FATIGUE (felt tired, stayed in bed all day.), HEADACHE (headache) and NAUSEA (nausea). At the time of the report, PAIN IN EXTREMITY (Pain in their arm), FATIGUE (felt tired, stayed in bed all day.), HEADACHE (headache) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to US-MODERNATX, INC.-MOD-2021-027768 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-027768:Crosslinked case
This spontaneous report as received from a register nurse concerning a 27 year old female patient with no pertinent medical history or drug reactions/allergies who on 25-APR-2013 the patient was vaccinated with PNEUMOVAX23 0.5 ml, intramuscular (lot number H01419G, expiration date 19-MAR-2014). No co-suspect or concomitant medications were reported. Nurse stated that the patient reported that the site was sore after receiving vaccination then on that evening, patient that her arm "felt heavy" and patient reported she was unable to lift her arm. Nurse stated additionally patient reported that the side of her body where PNEUMOVAX23 was administered was painful, her breast was painful to touch, her armpit was painful to touch. Nurse stated that the patient reported no bruising, and that the area where vaccine was give was not swollen but the site was hot and red.. Nurse states patient called an unspecified doctor's office who advised taking an un unspecified antihistamine which patient did take. Nurse stated that from patient that doctor offered to provide patient a cortisone shot yet patient declined cortisone shot. No laboratory tests were performed. Nurse states patient reports issues slowly resolved by Monday, 29-APR-2013. Additional information has been requested.
pain at infection site, pain down my left arm, pain in armpit under left arm, pain on side of left breast and on left back side. pain in shoulder of left arm. Pain lasted over a week (this was just the first shot).The second shot on 6/26/2021 at pain in injection site and left arm. Breast pinching pain in left breast and lump found a few weeks after 2nd does. I never, ever have breast pain not even hormonal, but have had issues in my left breast since the 2 dose covid vaccine.