chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Chills; body aches; fatigue; Inappropriate schedule of vaccine administered; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 24Jan2023 at 10:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 67 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "GERD" (unspecified if ongoing). Concomitant medication(s) included: OMEPRAZOLE; ROSUVASTATIN. Vaccination history included: BNT162b2, BNT162b2 omi ba.4-5 (Pfizer, lot number: Unknown, dose number: 3, vaccine location: Left arm.), administration date: 24Jan2023, for COVID-19 Immunization; Covid-19 vaccine (Dose 2, Manufacturer Unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 1, Manufacturer Unknown), for COVID-19 immunization. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 24Jan2023 at 10:00, outcome "unknown", described as "Inappropriate schedule of vaccine administered"; CHILLS (non-serious) with onset 24Jan2023 at 18:00, outcome "recovered" (25Jan2023 at 06:00); PAIN (non-serious) with onset 24Jan2023 at 18:00, outcome "recovered" (25Jan2023 at 06:00), described as "body aches"; FATIGUE (non-serious) with onset 24Jan2023 at 18:00, outcome "recovered" (25Jan2023 at 06:00). Therapeutic measures were not taken as a result of chills, pain, fatigue.  Additional information: Chills, body aches, fatigue starting approx. 8 hours after dose, and continuing for about 12 hours. No covid prior vaccination. No covid tested post vaccination. No known allergies. No other vaccine in four weeks. Other medications in two weeks including Omeprazole, Rosuvastatin. Facility type vaccine was reported that Doctor's office/urgent care.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
swelling, erythema and warmth over injection site. Occurred day of injection and spread. Used ice.
side effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (side effects) 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 (side effects). At the time of the report, VACCINATION COMPLICATION (side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Severe arm pain, my arm has been none stop tingling for two weeks, it feels like it is asleep constantly. the pain in my arm is so bad after two weeks that i cannot use my arm for many things. my arm is weak, and constantly asleep. it feels like my muscle was effected by this
This initial spontaneous case, was received from pharmacist (consumer) on 18-Oct-2017, concerning a patient of an unspecified age and gender. The patient's mother's current condition included breastfeeding. On 06-Oct-2017, the patient's mother was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml, anatomical location: left arm, batch number, expiry date, route of administration: not reported). The patient's mother received the vaccine, which had been stored under temperature up to 53 F for an undetermined amount of time and patient (baby) received the vaccine via breastfeeding. No adverse event was reported. The reporter assessed the events as non-serious.
Following vax pt developed a fever, generalized tonic-clonic convuls, rhinorrhea, pharyngitis, vomiting, & diarrhea; Probable indicative of viral illness, CBC & lytes were normal;
syncope 3pm both days of both shots and syncope cardiac arrest 9/18/21
nausea; sweat; body ache; Chest pain/ 3 episodes of Chest pain in 24 hrs; Chills; Localized Swelling; dizziness; This case was reported by a physician via call center representative and described the occurrence of local swelling in a 55-year-old female patient who received Herpes zoster (Shingrix) (batch number 9LH3Y, expiry date 7th February 2022) for prophylaxis.   On 31st October 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 weeks after receiving Shingrix, the patient experienced local swelling, dizziness, nausea, sweating, general body pain, chest pain and chills. On an unknown date, the outcome of the local swelling, dizziness, nausea, sweating, general body pain and chest pain were recovered/resolved and the outcome of the chills was unknown.   It was unknown if the reporter considered the local swelling, dizziness, nausea, sweating, general body pain, chest pain and chills to be related to Shingrix.  Additional details were reported as follows: The physician reported that patient presented localized swelling, 4 days of dizziness, nausea , sweat and chills, body ache, 3 episodes of chest pain in 24 hours after the first dose of Shingrix. The reporter consented to follow up. This case is linked with case US2020222218, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020222218:(Deleted- No GSK product)
"Aching in chest, cold - flu symptoms, feverish" after Tdap placed on 10/16/07. Treatment with Amoxicillin and Dumt JSS GP:
Patient was given 0.2mL dose of the adult dosage Pfizer vaccine. Father was notified as soon as it happened. Pt was watched for 30 mins with no adverse reaction. Father informed that pt. will still need 2nd dose and understanding was verbalized.
pt recv vax 17MAY96 & 5MAR97 pt devel @ least 50 vesicles severe case;by 15MAR97 pt recovered;
Had a normal menstrual cycle March 23 - March 27 after my 2nd vaccine (except for EXTREME heavy bleeding on day 4). Was off my cycle for one and a half weeks and then started my period agian for another two and a half weeks, April 7 - April 23. 1st dose: 02/13/21 2nd dose 03/13/21
Vaccine was stored in fridge on 17-May-2022 and was administered on 17-May-2022; Administered vaccine on 17-May-2022 and found out that the vaccine had been expired for 2 weeks; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered vaccine on 17-May-2022 and found out that the vaccine had been expired for 2 weeks) and PRODUCT STORAGE ERROR (Vaccine was stored in fridge on 17-May-2022 and was administered on 17-May-2022) in a 57-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 076C21A and 083J21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: JANSSEN COVID-19 VACCINE (Primary dose (Dose 1) and lot number; 1805031) on 12-Mar-2021. Past adverse reactions to the above products included No adverse event with JANSSEN COVID-19 VACCINE. Concurrent medical conditions included Penicillin allergy.   On 16-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered vaccine on 17-May-2022 and found out that the vaccine had been expired for 2 weeks). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in fridge on 17-May-2022 and was administered on 17-May-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered vaccine on 17-May-2022 and found out that the vaccine had been expired for 2 weeks) and PRODUCT STORAGE ERROR (Vaccine was stored in fridge on 17-May-2022 and was administered on 17-May-2022) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative Negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The health care professional (HCP) states that they administered the Moderna COVID 19 vaccine on 17-May-2022 and found out that the vaccine had been expired for 2 weeks. The HCP explains that since the expiration date was not written on the vial, they did not notice it had already expired. On 17-May-2022, the vial was initially stored in the refrigerator and the vial did not undergo any temperature excursions.  No treatment medications were reported.
This spontaneous report received from a healthcare professional concerned a 51-year-old male. No medical history, weight, height, concomitant medications or concurrent conditions reported. The patient received COVID-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch/lot# 1821286 and expiry: Mar 20, 2022), dose not reported, on Nov 1, 2021, for immunization. Age at time of vaccination: 51 years old.  On Nov 1, 2021, administration of refrozen vaccine. On an unspecified date, patient experienced vaccine refrozen. The action taken with COVID-19 vaccine ad26.cov2.s: not applicable. The outcome of the vaccine refrozen and administration of refrozen vaccine: not reported. This case, from the same reporter linked to 20220538379, 20220537507, 20220538627, 20220537683, 20220537341, 20220538437, 20220538573, 20220537444, 20220538666, 20220538292, 20220537548, 20220538347, 20220538411, 20220539045, 20220537532, 20220538428, 20220538146, 20220538297, 20220538316, 20220538210, 20220538238, 20220538758, 20220537688, 20220537356, 20220538425, 20220538693 and 20220538149.
Patient reports he feels like he cannot get out of bed.  The symptoms started the evening of the vaccine and have continued through the reporting date (4/17/2021)
menquadfi temperature excursion that exceeded the stability at temperature 31.5 Fahrenheit and duration: 2 hours 45 minutes and vaccines were administered with no reported adverse event; Initial information was received on 03-Aug-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves meningococcal a-c-y-w135 (t conj) vaccine [menquadfi] temperature excursion that exceeded the stability at temperature 31.5 Fahrenheit and duration: 2 hours 45 minutes and and was administered to a 16 years old male patient 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 meningococcal vaccine b rfhbp/nada/nhba omv (Bexsero) for Immunisation.  On an unknown date, a dose of suspect meningococcal a-c-y-w135 (t conj) vaccine Solution for injection and a patient received at dose of 0.5 ml total via intramuscular route (strength: standard, lot number, expiration date, administration site: Unknown) for immunization (immunisation) temperature excursion that exceeded the stability at temperature 31.5 Fahrenheit and duration: 2 hours 45 minutes and vaccine was administered with no reported adverse event (poor quality product administered) (latency: same day). Information on the batch number was requested.   It was reported that "The products Adacel, Daptacel, Ipol, Menquadfi, Pentacel, Quadracel, Tenivac, Vaxelis at temperature 31.5 Fahrenheit and duration: 2 hours 45 minutes. These vaccines were administered to 40 patients over a span of 1 week, starting on 15-Jun-2023 till stopping at 22-Jun-2023. Menquadfi administered."  No lab data reported.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event menquadfi temperature excursion that exceeded the stability at temperature 31.5 Fahrenheit and duration: 2 hours 45 minutes and vaccines were administered with no reported adverse event.   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.; Sender's Comments:  US-SA-2023SA240011:01715866 US-SA-2023SA238269:01715866
Stiffness below skull with pain from same area down to tailbone, nausea, unable to get a full breath, severe headache and light sensitive.
I received my first booster from Moderna for COVID-19 on 9/1/2021. Late in the night of 3/26/2022, I began having body aches and fatigue. On 3/27/2022, I took a home test for COVID-19, as I had just recently been exposed to the virus, and the result was positive. From that point on, I had a different symptom each day. I developed a headache one day, a fever of 103 accompanied by chills one night, and a sore throat another day. On about 3/27/2022, I had symptoms that were similar to those of sinusitis. My sinuses felt tender, and the pressure caused my teeth to hurt. The pressure then gradually moved to my chest, and I then subsequently developed a severe cough. Other than the cough, the sinus pressure, and the chest congestion (which caused my chest to ache), my symptoms subsided around 3/31/2022. I still tested positive for COVID-19 at this point. Since I still had the cough and sinus and chest congestion, I knew that I needed to see a doctor. I saw a doctor during the first week of April 2022. I underwent a chest X-ray, and pneumonia was detected in the lower right lobe. I was then prescribed a combination of amoxicillin and doxycycline. I began to feel a little better after about a day or two of taking the antibiotics, though the cough persisted. I finished the antibiotics after 10 days. I felt better at this point, but I still had a cough and some chest pain. I then went back to the doctor, and I was prescribed another 10-day round of the amoxicillin-doxycycline mixture. After those 10 days were up, I felt fine, though I still had a lingering cough. It took about 2 months for the cough to finally subside. On about 4/5/2022, I took another home COVID-19 test, and I got a negative result. On about 4/13/2022, I developed strep throat. This time around, I was just prescribed a 7-day supply of pure amoxicillin, and it was effective. After taking the amoxicillin for about 2-3 days, I felt much better. I'm normally a very healthy and active, and I hardly ever get sick.
Nothing after first dose.  Received second dose as mentioned above at 10:30 AM and 12 hours later (10:30 PM) began experiencing severe chills, body aches, joint paint, fever, sever migraine type headache for 16 hours.  21 hours after the vaccine (7:30 AM) following day I woke up to a severely itching forehead and face and was scratching it....when I got out of bed I realized it is all over my body. It's warm to the touch and red, blotchy everywhere and it's sever on my forehead with white puss filled bumps.
CHEST PAIN; BODY ACHES; ITCHING TO ARM AND NECK; DIZZY; VOMITING; NAUSEA; HEADACHE; SWELLING AT INJECTION SITE; This spontaneous report received from a patient concerned a 36 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included antibiotics (unspecified) drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, expiry: UNKNOWN) dose was not reported, administered on 30-MAR-2021 09:30 on left arm for prophylactic vaccination. No concomitant medications were reported. On 30-MAR-2021, the subject experienced chest pain. On 30-MAR-2021, the subject experienced body aches. On 30-MAR-2021, the subject experienced itching to arm and neck. On 30-MAR-2021, the subject experienced dizzy. On 30-MAR-2021, the subject experienced vomiting. On 30-MAR-2021, the subject experienced nausea. On 30-MAR-2021, the subject experienced headache. On 30-MAR-2021, the subject experienced swelling at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, swelling at injection site, itching to arm and neck, nausea, chest pain, dizzy, body aches and vomiting was not reported. This report was non-serious.
This spontaneous report as received from a nurse practitioner refers to a group of unspecified patients. The patients were vaccinated with LIQUID PEDVAXHIB (date, route and lot number unknown). No other co-suspects were reported. No concomitant medications were reported. On unknown dates the patients received vaccine doses that were exposed to temperatures above 46 F for 45 minutes, with the highest temperature of 78 F for 15 minutes. No adverse effect reported. No treatment information was reported. Information about GARDASIL, PNEUMOVAX 23, VAQTA and RECOMBIVAX HB that were exposed to temperatures above 46F for 45 minutes, with the highest temperature of 78 F for 15 minutes is also reported. This is information is processed in the linked cases: 1210USA007111, 1211USA001302, 1211USA001296 and 1211USA001297. Additional information has been requested.
injection site hot; injection site itchy; injection site turned red; arm hurt; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 26-Apr-2021 and was forwarded to Moderna on 26-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm hurt), VACCINATION SITE WARMTH (injection site hot), VACCINATION SITE PRURITUS (injection site itchy) and VACCINATION SITE ERYTHEMA (injection site turned red) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination.     No relevant medical history provided.     On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, the patient experienced PAIN IN EXTREMITY (arm hurt). On 19-Apr-2021, the patient experienced VACCINATION SITE WARMTH (injection site hot), VACCINATION SITE PRURITUS (injection site itchy) and VACCINATION SITE ERYTHEMA (injection site turned red). On 19-Apr-2021, PAIN IN EXTREMITY (arm hurt) had resolved. At the time of the report, VACCINATION SITE WARMTH (injection site hot), VACCINATION SITE PRURITUS (injection site itchy) and VACCINATION SITE ERYTHEMA (injection site turned red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient received vaccination at Vaccination place.  Treatment information was not provided.
mom reports on 7MAY93 very casually that on evening of immun pt t99.2 R & pt's eyes briefly rolled up in hand & stiffened briefly; fine in a second & since;
Red swollen bumps on first joints of all fingers on both hands, difficulty bending fingers, painful and achy.  First occurred several weeks after second shot and is ongoing.
tongue is red and burns at the tip; swelling in gums; Gums, upper and lower lips are swollen; tongue is red and burns at the tip; difficulty biting; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 79-year-old female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose:1, Caller received Pfizer covid vaccine 2 doses and a booster shot.), for Covid-19 Immunization; Bnt162b2 (Dose: 2, Caller received Pfizer covid vaccine 2 doses and a booster shot.), for Covid-19 Immunization, reaction(s): "dry, cracking and pealing lips", "difficulty eating or speaking", "dry, cracking and pealing lips", "dry, cracking and pealing lips", "cuts/slits on the corner of the mouth", "cuts/slits on the corner of the mouth, it hurt", "on the back of her leg/thigh she has developed like "ringworms" round circle, red and white in the center and has a little red dots next to it". The following information was reported: TONGUE DISCOMFORT (non-serious), TONGUE ERYTHEMA (non-serious), outcome "unknown" and all described as "tongue is red and burns at the tip"; GINGIVAL SWELLING (non-serious), outcome "unknown", described as "swelling in gums"; LIP SWELLING (non-serious), outcome "unknown", described as "Gums, upper and lower lips are swollen"; EATING DISORDER (non-serious), outcome "not recovered", described as "difficulty biting". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: After the 2nd shot (about 10 days later) on the back of her leg/thigh she has developed like ''ringworms'' round circle, red and white in the center and has a little red dots next to it; A few days later she had dry, cracking, and pealing lips, cuts/slits on the corner of the mouth, it hurt, difficulty eating or speaking, it did subside but not gone away. She saw the doctor and was prescribed cortisone cream. She stated she still has them, but they don't hurt or itch anymore. She states she has been living with this and threaten to sue Pfizer; its been about 6 month.  She stated she then received a booster dose. with the booster dose everything was in the mouth; swelling in gums, white lines in the gum, mostly on the bottom but some on the top, seem the oral doctor biopsied not cancer, doctor suggested to get a laser treatment to get rid of the white line but stated she is not going to get that. Her Gums, upper and lower lips are swollen still she has difficulty biting and now it's on both cheeks also, Her tongue was red and burns at the tip. Her HCP stated it came from the shot, she has seen 3 doctors. She stated Pfizer should provide advice on what to do, this injection is terrible the reporter wanted to know about the symptoms.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
it began to swell; rash; hives; itch; my arm was tender and painful; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 04Oct2021 11:30 (Lot number: FF2589) at the age of 70 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "CABG" (unspecified if ongoing), notes: CABG; "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin; "Hypothyroid" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6200, Location of injection: Right arm, Vaccine Administration Time: 03:00 PM, Route of administration: Intramuscular), administration date: 17Feb2021, when the patient was 70 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: EN6200, Location of injection: Right arm, Vaccine Administration Time: 02:00 PM, Route of administration: Intramuscular), administration date: 10Mar2021, when the patient was 70 years old, for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 05Oct2021, outcome "recovering", described as "my arm was tender and painful"; PERIPHERAL SWELLING (non-serious) with onset 06Oct2021, outcome "recovering", described as "it began to swell"; RASH (non-serious) with onset 06Oct2021, outcome "recovering", described as "rash"; URTICARIA (non-serious) with onset 06Oct2021, outcome "recovering", described as "hives"; PRURITUS (non-serious) with onset 06Oct2021, outcome "recovering", described as "itch". Therapeutic measures were not taken as a result of pain in extremity, peripheral swelling, rash, urticaria, pruritus.  No follow-up attempts are possible. No further information is expected.