chrisvoncsefalvay/vaers-outcomes huggingface dataset:
feeling unwell; Just stayed in bed and rode it out.; slight rash at injection sight/red rash; injection site itchy; armpit swollen/armpit swollen; 103 fever; sweats; severe pounding headache; no energy; tired; chills; wiped out/weak; nausea; diarrhea; no appetite; This is a spontaneous report from a contactable consumer or other non hcp.   A 57-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot Number: ER8729) dose 2 via an unspecified route of administration, administered in right arm on 07Apr2021 11:00 as SINGLE DOSE for covid-19 immunization.  Medical history included Blood pressure, Diabetic, potassium and some known allergies of Sulfa, Bees. Historical vaccine was covid 19. The patient's concomitant medications were not reported. On 08Apr2021 at 12:00 AM, the patient experienced chills, sweats, up to 103 fever, severe pounding headache, no energy, tired/wiped out/weak, nausea, diarrhea, no appetite, red rash at injection site, itchy, armpit swollen, started about about 12 hours after shot. The patient stated that first 3 days was roughest. Everything above lasted for 4 days. Day 5 just little energy, feeling unwell and slight rash at injection sight/sight swelling armpit and no appetite. Just stayed in bed and rode it out. The outcome of the events was reported as recovering. The action taken in response to the events for bnt162b2 was not applicable.
had fevers; chills; has the pain at site of injection; muscle aches in her lower back; muscle aches in / knees; Lack of appetite; abdominal discomfort; fatigue; This case was reported by a consumer via call center representative and described the occurrence of fever in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th August 2020, the patient received the 1st dose of Shingrix (intramuscular). In August 2020, less than a week after receiving Shingrix, the patient experienced muscular back pain, muscle pain, appetite absent, abdominal discomfort and fatigue. On 18th August 2020, the patient experienced fever, chills and injection site pain. On an unknown date, the outcome of the fever, injection site pain and muscular back pain were recovered/resolved and the outcome of the chills and muscle pain were unknown and the outcome of the appetite absent, abdominal discomfort and fatigue were not recovered/not resolved.   It was unknown if the reporter considered the fever, chills, injection site pain, muscular back pain, muscle pain, appetite absent, abdominal discomfort and fatigue to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced fevers and chills that lasted into that evening but resolved by the following day.  The reporter also stated that she had the pain at site of injection, muscle aches in her lower back and knees, abdominal discomfort, lack of appetite and fatigue.  The muscle aches and pain at site of injection have completely resolved and the fatigue has gotten better but has not resolved completely.  The reporter also stated that she does sill have abdominal discomfort and lack of appetite. The reporter did not consent to follow up.
vaccine brand other: Janssen, vaccine dose number: 1; vaccine brand: Pfizer / BioNTech; Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 24Sep2022 at 12:30 as dose 3 (booster), single (Lot number: GJ5342) at the age of 43 years, in left arm for covid-19 immunisation; BNT162b2 (COMIRNATY), on 16Dec2021 at 11:00 as dose 2 (booster), single (Lot number: FH8020), in left arm for covid-19 immunisation; coviD-19 vaccine nrvv ad26 (jnj 78436735) (JANSSEN COVID-19 VACCINE), on 09Apr2021 at 15:00 as dose 1, single (Lot number: 042A21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Palindromic rheumatism" (unspecified if ongoing); "known allergies: Shellfish" (unspecified if ongoing); "known allergies: walnuts/hazelnuts" (unspecified if ongoing); "known allergies: peanuts" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Ampicillin, reaction(s): "known allergies: Ampicillin"; Lidocaine, reaction(s): "known allergies: possible allergy to lidocaine". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "vaccine brand other: Janssen, vaccine dose number: 1; vaccine brand: Pfizer / BioNTech". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included PAXLOVID..
Patient was given Meningitis B in error.   MCV4 should have been given.
red marble size blood stain surrounding another red blood ring and black and blue of about 3 inches. It is like and imprint.
This prospective pregnancy report has been received from a 35 year old female patient reporting on herself. The patient had no pertinent medical history or drug reactions/allergies. The patient's concurrent conditions and concomitant therapies were not reported. On 01-SEP-2017 the patient was vaccinated with VARIVAX one injection for prophylaxis. The route of administration was reported as injection. Dose, number dose, lot number and expiration date were not provided. Other suspect therapies included the sterile diluent (unknown lot number and expiration date). The patient stated that she found out she was pregnant on 05-SEP-2017 and that she believed she was 4 or 5 weeks pregnant at the time of vaccination. Date of Last Menstrual Period (LMP) was 08-AUG-2017 and the Estimated Date of Delivery (EDD) was 15-MAY-2018. The patient explained that a doctor had not yet verified her pregnancy. The pregnancy outcome was unknown. The patient declined to provide her physician's contact and declined to allow follow-up contact regarding her pregnancy.
After receiving my second dose on a Saturday, 2 months after my first dose, I had chest pain that started 48 hours after the shot (that Monday) and was hospitalized by Wednesday with peak troponin levels of 4.68 and ALT levels were elevated as well.  I have recently had an echo and my ejection fraction has reduced since I?ve been hospitalized as well
CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 43 year old male. Initial information processed along with additional information received on 13-JUL-2022. The patient's height, and weight were not reported. The patient's concurrent conditions included: allergy. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1)(suspension for injection, route of admin, and batch number were not reported) dose was not reported 01 total administered to the left arm on 08-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Age at time of vaccination 42 years old. No concomitant medications were reported.  The patient additionally received non-company suspect vaccine: elasomeran (moderna covid-19 vaccine)(dose number in series 2)(form of admin, route of admin, and batch number were not reported) dose was not reported, administered on 26-OCT-2021 for prophylactic vaccination.  On an unspecified date, the patient experienced confirmed covid-19 infection (dose number in series 2) and had confirmed clinical vaccination failure (dose number in series 1). Laboratory data (dates unspecified) included: COVID-19 antigen test Positive, COVID-19 antigen test Negative. The patient received paxlovid (form of admin, route of admin, batch number were not reported), administered from 24-JUN-2022 to 29-JUN-2022 for treatment of Covid-19. The patient retested antigen positive for Covid-19 after 5 days of negative and 4 days after completing treating with Paxlovid The action taken with covid-19 vaccine ad26.cov2.s, and elasomeran was not applicable. The outcome of the confirmed covid-19 infection and confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint number.; Sender's Comments: V0-20220721597 -COVID-19 VACCINE Ad26.COV2.S- Confirmed clinical vaccination failure. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Erythema and swelling at injection sight on right thigh. Also had urticaria on face and back. Given Benadryl and observed X 45 minutes. Urticaria resolved and pt discharged with instructions to continue Benadryl for the next 2 days.
Information has been received from a medical assistant concerning an 18 year old female who on 24-MAY-2007 was vaccinated with a dose of Gardasil (lot #655503/0012U) 0.5 ml injection. Concomitant therapy included "DEPO" therapy unspecified. Subsequently, the patient experienced tingling and numbness in her legs, headaches, chest pressure and heart complications. At the time of reporting, the patient had recovered. Additional information has been requested.  01/07/2008 This is in follow-up to report(s) previously submitted on 8/14/2007; 10/8/2007. In follow-up it was reported in Medical records that the patient visited the physician's office on 24-JUL-2007, the patient an 18 year old female who on 24-MAY-2007 was vaccinated intramuscularly into the left deltoid muscle with the first dose of GARDASIL (lot # 655503/0012U) 0.5 ml injection. The patient reported that after the first injection of GARDASIL, the patient complained of numbness and tingling to the lower extremities, sharp chest pain, one week later, approximately on 31-MAY-2007. The patient stated that she received a "DEPO" shot on 03-JUL-2007. One week ago, approximately 17-JUL-2007, the patient complained of numbness to the left arm. The series of GARDASIL was discontinued. The patient stated that she took ADVIL when symptoms occurred with good relief. The patient was informed to go to the Emergency Room if symptoms re-occurred without relief. Additional information has been requested.
rash all over the abdomen; sore arm; really tired; weak; really bad headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), FATIGUE (really tired), ASTHENIA (weak), HEADACHE (really bad headache) and RASH (rash all over the abdomen) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) and SPIRONOLACTONE for an unknown indication.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm), FATIGUE (really tired), ASTHENIA (weak) and HEADACHE (really bad headache). On 17-Mar-2021, the patient experienced RASH (rash all over the abdomen). At the time of the report, PAIN IN EXTREMITY (sore arm), FATIGUE (really tired), ASTHENIA (weak), HEADACHE (really bad headache) and RASH (rash all over the abdomen) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.
This initial spontaneous report was received on 11-SEP-2018 from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Information regarding medical history, concurrent conditions and concomitant medications was not provided. In 2011, the patient was inoculated with ZOSTAVAX at a Health Department as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles. In 2016, the patient was treated at a hospital for a vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Patient became dizzy.  Patient was given a glass of water and laid down on exam table.  After twenty minutes patient felt fine and left the doctors office.
At 10 am took 1 Benedryl caplet. Had Vaccine at 10:30am. At 11:30am mouth and throat very dry.Drank water then felt throat starting to tighten and took 1 more Benedryl.  A little bit later felt drowsy and somewhat dazed. Approx 12:30 pm got a severe headache and neck pain. At 2:30 pm the pain abruptly disappeared without me taking anything for it.  Very sore arm was the only effect left. Still sore after 2 days.
injection site red, swollen and hot to touch; injection site red; injection site swollen; injection site hot to touch; Initial information was received on 24-Sep-2020 regarding an unsolicited valid non-serious case from a consumer/non-healthcare professional.  This case involves a 36 year old female patient whose injection site was red, swollen and hot to touch (injection site inflammation), while she received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On 17-Sep-2020, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot number not reported via unknown route on the underside of her upper left arm for prophylactic vaccination  On an unknown date, the patient injection site was red, swollen and hot to touch (injection site inflammation) with symptoms: injection site erythema, injection site swelling and injection site warmth (unknown latency, non-serious event) following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  No laboratory data was provided  It was not reported if the patient received a corrective treatment.  At the time of report, the outcome of event was unknown.  There will be no information available on lot number.
Patient did not receive 2nd dose between day 25-35 of the 1st dose.; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient did not receive 2nd dose between day 25-35 of the 1st dose.) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient did not receive 2nd dose between day 25-35 of the 1st dose.). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient did not receive 2nd dose between day 25-35 of the 1st dose.) had resolved.        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.   No concomitant medication were reported. No treatment information was reported
p/vax pt devel generalized lymphadenopathy;MD performed a biopsy on one of the nodes which was negative;
Woke up with a runny nose and then I had a sore throat, cough, lost my voice and was isolated for 10 days. No fever, aches or not as much exhaustion as I had received from the vaccine itself. I kind of still have residual symptoms - blocked nose, sneezing a lot and coughing when I'm lying down. I am currently taking Zyrtec and nasal spray - OTC. Two doctor visits so far - one for diagnosis and one for follow up.
It is like her mind is still in the daydream; She is still a little out of it./This feeling was very strange; It was like she was drunk, and everything was moving slow; Dizziness; Weakness; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team. The reporter is the patient. Other Case identifier(s): US-PFIZER INC-202100941075 (Pfizer).  A 37 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 23Jul2021 09:29 (Lot number: EWO168) at the age of 37 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIZZINESS (non-serious) with onset 23Jul2021 09:44, outcome "recovering", described as "Dizziness"; ASTHENIA (non-serious) with onset 23Jul2021, outcome "recovering", described as "Weakness"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "It is like her mind is still in the daydream; She is still a little out of it./This feeling was very strange"; FEELING DRUNK (non-serious), outcome "unknown", described as "It was like she was drunk, and everything was moving slow". The event "dizziness" was evaluated at the emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information : Reporter reported that the symptoms seem to have stayed at a baseline now. She reports that after the event she was looking over the paper work that was given to get after the vaccine and it lists dizziness and weakness as severe side effects. She relayed that it doesn't say if it is severe dizziness and weakness or mild that is considered to be a severe side effect. She would like to know if she is going to be okay. She has no medical history. She has been allergic to fish since childhood. She takes no medications.  No follow-up attempts are possible. No further information is expected.
This spontaneous report was received from a physician via company representatives, referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 01-MAR-2016, the patient was vaccinated with improperly stored dose of RECOMBIVAX HB (Lot No. K007263; expiration date 09-JUN-2016) "SDV;10 pack", (Route of administration and anatomical location were not reported). There was no concomitant therapy reported. On unspecified dates, the RECOMBIVAX HB had three temperature excursions: one of 16 hours, 168 hours and 896 hours. The lowest recorded temperature was 32 F and the highest recorded temperature was 34 F (1.111111111 Celsius). No adverse effects reported and no product quality complaint was involved. The vaccine status was reported as "in excursion". The vaccine storage criteria and the storage type of excursion were reported as "Refrigerator(R)". This is one of several cases from the same reporter. Additional information has been requested.
received booster from expired vial; Hot flashes to chills; Headaches; Achy joints; Hot flashes to chills; This spontaneous case was reported by a physician and describes the occurrence of HOT FLUSH (Hot flashes to chills), HEADACHE (Headaches), ARTHRALGIA (Achy joints), CHILLS (Hot flashes to chills) and EXPIRED PRODUCT ADMINISTERED (received booster from expired vial) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038C21A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy (PCN (Penicillin)) and ADHD. Concomitant products included INFLUENZA VACCINE (FLUZONE [INFLUENZA VACCINE]) for Vaccination.    On 29-Oct-2021 at 11:45 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 ml. In October 2021, the patient experienced HOT FLUSH (Hot flashes to chills), HEADACHE (Headaches), ARTHRALGIA (Achy joints) and CHILLS (Hot flashes to chills). On 29-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received booster from expired vial). The patient was treated with AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) (oral) ongoing since an unknown date for ADHD, at a dose of 25 mg once a day. On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (received booster from expired vial) had resolved. At the time of the report, HOT FLUSH (Hot flashes to chills), HEADACHE (Headaches), ARTHRALGIA (Achy joints) and CHILLS (Hot flashes to chills) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medications were reported. The adverse events occurred after 24-48 hours of receiving the vaccine.   Most recent FOLLOW-UP information incorporated above includes: On 05-Nov-2021: follow up received contains updated reporter type, patient demographic details, medical history, added concomitant medications and added events
Injection site start peeling; Injection site turn red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE EXFOLIATION (Injection site start peeling) and VACCINATION SITE ERYTHEMA (Injection site turn red) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE EXFOLIATION (Injection site start peeling) and VACCINATION SITE ERYTHEMA (Injection site turn red). At the time of the report, VACCINATION SITE EXFOLIATION (Injection site start peeling) and VACCINATION SITE ERYTHEMA (Injection site turn red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported. No treatment medication was reported.
p/vax pt devel red rash from neck to waist which itched; fever; flu-like symptoms; nasal congestion; pt felt fatigues & achy; rash lasted 24hr; tx: DPH for rash & zithromax for other symptoms; sx resolved p/ 1-2wk
devel Hep A and Hep B; Idiosyncratic rxn; now has Hep C; anorexic, taste and smell blood; bone pain, swollen liver
Woke up with a fever, chills, and a headache. Worse than any flu I?ve had.
This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 62-year-old female patient who received SHINGRIX (batch number 957J3, expiry date unknown) for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of injection site rash (1st dose received on 25th February 2018, see the case US2018GSK151929). On 10th August 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. In August 2018, less than a week after receiving SHINGRIX, the patient experienced fever and enlargement of lymph nodes. On an unknown date, the outcome of the fever and enlargement of lymph nodes were unknown. It was unknown if the reporter considered the fever and enlargement of lymph nodes to be related to SHINGRIX. Additional details were provided as follows: The patient received 2nd dose of SHINGRIX in left arm. The patient experienced fever and swollen lymph node along her collar bone area with the 2nd dose of the SHINGRIX vaccine. No further details were provided by the pharmacist.