chrisvoncsefalvay/vaers-outcomes huggingface dataset:
mult vax started day before rash noted on face;took vax @ home same day as other vax about 530PM;2hr later noted burning sensation on face;reported to clinic next  day about 130PM p/seeing rash on face;told stop typhoid;feel r/t typhoid
PATIENT HAD A REACTION ON LEFT POSTERIOR THIGH WHERE VARICELLA VACCINE WAS GIVEN.PATIENT HAS A RAISED REDENED AREA APPROX THE SIZE OF A 50 CENT PIECE. AREA IS WARM TO TOUCH.
Pt admitted on 3/20 for NSTEMI and possible evolving community acquired pneumonia. Pt was tested for COVID on admission and was negative. Pt was retested for COVID prior to discharge on 3/28 and was positive. RN stated that pt had developed a worsening cough.
Systemic: Allergic: Rash (specify: facial area, extremeties)-Severe, Systemic: Allergic: Rash Generalized-Severe, Additional Details: patient had rash on left arm on entire arm.  stated also went to other arm and was continuing to get worse on Monday 8/15/2022.  advised pt to go to urgent care/er.  did not hear back from patient as of 08/17/2022
On 11/15/2022 had check up with PCP routine blood work indicated elevated bilirubin levels; scheduled abdominal ultrasound 12/19/2022.
I am a 52 year old female in great health. I am not taking any medication. I was administered the FLUARIX Quad flu vaccine in the P.M. on 09/23/17. 12 hours later, early Sunday A.M. I got up to use the restroom. While returning to bed I started feeling nauseous and hot. In a matter of seconds I blacked out an my body hit a console table breaking everything sitting on it. I ended up seriously injuring my tailbone from landing on the ceramic tile floor. I am fortunate I didn't crack my head open as well. I've had flu vaccines for the past 5 years and never had side effects. This is the first time I passed out in my lifetime. The flu shot was the only usual event experienced that day. I originally blacked out at 4A.M. 09/25/17 and continued to have symptoms of blacking out through 10A.M. This will be the last time  I get a flu shot. I will risk the flu rather than suffer through a tailbone injury for weeks or months.
8 days after receiving the first dose of the Moderna vaccine, patient developed itching & subsequent red raised rash approximately the diameter of a baseball @ the left upper arm injection site.  Rash & itching lasted 3-5 days.
COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Oct2022 as dose 5 (booster), single (Lot number: GH9693) at the age of 65 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 03Mar2021 as dose 1, single (Lot number: EN6198), on 24Mar2021 as dose 2, single (Lot number: EP6955), on 12Nov2021 as dose 3 (booster), single (Lot number: FG3527) and on 05Aug2022 as dose 4 (booster), single (Lot number: FM0173) for covid-19 immunisation. The patient's relevant medical history included: "Overweight" (unspecified if ongoing); "Sulfa allergies" (unspecified if ongoing); "Penicillin allergies" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 17Jul2023, outcome "recovering" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: Body temperature: (Jul2023) never over 101; SARS-CoV-2 test: (26Jul2023) negative; (29Jul2023) positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient was contracted with Covid on 17Jul2023. Fever (never over 101), headache, congestion, dry cough. She received Paxlovid from 17Jul2023 to 22Jul2023 as treatment of COVID-19.
Patient received VAXNEUVANCE and had injection site swelling and muscle aches following administration of VAXNEUVANCE.; Patient received VAXNEUVANCE and had injection site swelling and muscle aches following administration of VAXNEUVANCE.; This spontaneous report has been received from a physician, regarding herself, a 48 years-old non pregnant female patient. The patient's medical history included asthma as current condition. Previous drug reaction included injection site swelling and muscle aches after the administration of a COVID vaccines (manufacturer unknown). Allergies and concomitant medications were not reported.  On 26-MAY-2022, the patient was vaccinated with pneumococcal 15v conj vaccine (CRM197) (VAXNEUVANCE) intramuscularly as prevention of invasive pneumococcal disease (strength, dose, scheme, lot number and expiration date were not reported.  On the same day, the patient experienced injection site swelling and muscle aches (myalgia) following administration of pneumococcal 15v conj vaccine (CRM197) (VAXNEUVANCE). The patient did not received treatment. The outcome of the events was reported as recovering.   The causal relationship between injection site swelling and (myalgia) and pneumococcal 15v conj vaccine (CRM197) (VAXNEUVANCE) was not reported.
Patient experienced fever of 102 degrees farenheit and had diarrhea three times. This resolved on its own over the next 24 hours.
Tested positive for COVID-19 and admitted to hospital. Symptoms include chills and shortness of breath.
Nausea, fever, body aches, headaches, same symptoms as when I had Covid19.  Arm very sore still.
very big pain; Bruise in injection site; Neck is swollen; neck is very very sore; neck is stiff; can't pop up my neck; can't swallow; Rash was described as red little bumps and itchy; rash,rash in upper legs and upper arms; fever; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN (very big pain), VACCINATION SITE BRUISING (Bruise in injection site), SWELLING (Neck is swollen), NECK PAIN (neck is very very sore) and MUSCULOSKELETAL STIFFNESS (neck is stiff) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LAMOTRIGINE (LAMICTAL) for Convulsions.    On 01-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN (very big pain), VACCINATION SITE BRUISING (Bruise in injection site), SWELLING (Neck is swollen), NECK PAIN (neck is very very sore), MUSCULOSKELETAL STIFFNESS (neck is stiff), MUSCULOSKELETAL DISCOMFORT (can't pop up my neck), DYSPHAGIA (can't swallow), URTICARIA (Rash was described as red little bumps and itchy), RASH (rash,rash in upper legs and upper arms) and PYREXIA (fever). At the time of the report, PAIN (very big pain), VACCINATION SITE BRUISING (Bruise in injection site), SWELLING (Neck is swollen), NECK PAIN (neck is very very sore), MUSCULOSKELETAL STIFFNESS (neck is stiff), MUSCULOSKELETAL DISCOMFORT (can't pop up my neck), DYSPHAGIA (can't swallow), URTICARIA (Rash was described as red little bumps and itchy) and PYREXIA (fever) outcome was unknown and RASH (rash,rash in upper legs and upper arms) was resolving.        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.   Treatment information was not provided.
Very sore left upper arm by evening.  Pain not noticed by day 3 after injection. No redness or shot site swelling.
Sore at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore at the injection site) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Sore at the injection site). At the time of the report, VACCINATION SITE PAIN (Sore at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.   No treatment information was provided.; 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.
This spontaneous report as received from a Licensed Practical Nurse refers to a patient of 14 years old adolescent patient and unknown gender. On 15-SEP-2014 the patient was vaccinated with a dose of an improperly stored GARDASIL (lot J015378, expiration date 09-APR-2016) (dose, route, were not reported). No adverse effect was reported. The outcome of events reported was unknown. No product quality complaint was involved. This is one of several reports received from the same source. Additional information has been requested.
This case was reported by a pharmacist via call center representative and described the occurrence of tiredness in a 97-year-old male patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included dementia. On 7th November 2018, the patient received the 1st dose of SHINGRIX. On 7th November 2018, less than a day after receiving SHINGRIX, the patient experienced tiredness, pain and agitation. On 9th November 2018, the patient experienced influenza-like symptoms. On 10th November 2018, the patient experienced confusion and forgetfulness. On an unknown date, the outcome of the tiredness was not recovered/not resolved and the outcome of the pain, agitation and influenza-like symptoms were unknown and the outcome of the confusion and forgetfulness were recovered/resolved. It was unknown if the reporter considered the tiredness, pain, agitation, influenza-like symptoms, confusion and forgetfulness to be related to SHINGRIX. Additional details were provided as follows: The patient with dementia received a dose of SHINGRIX on left deltoid at 11:30 pm and as soon as he was injected the vaccine, he was agitated and said that the injection was really sore. The patient's wife told the pharmacy that because of his dementia he could not distinguish between discomfort and pain. On 7th November 2018 and 8th November 2018, he was tired. On 9th November 2018, he was agitated and started flu like symptoms. The patient was confused and forgot how to brush his teeth, wash his face and swallow medications. The patient at the time of reporting remembered how to brush his teeth, wash his face and swallow his medications again. The reporter consented to follow up.
very weak; Caller states her mom was diagnosed with COVID-19 yesterday/Received first dose on 15Mar2021; diagnosed with Covid on 29Mar2021; Caller states her mom was diagnosed with COVID-19 yesterday/Received first dose on 15Mar2021; diagnosed with Covid on 29Mar2021; This is a spontaneous report from a contactable consumer or other non HCP. A 70-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 15Mar2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Caller stated that her mom was scheduled to receive the second dose on 02Apr2021. Her mom was diagnosed with COVID-19 on 29Mar2021. The patient had called (health department name) and they told her that her mother should wait 90 days to receive the second dose and then she would have to restart the series. The reporter would like to know what guidance there was for people who are diagnosed with COVID between doses and receiving their second doses and would like to know what the maximum amount of time is you should not go over between the first and second dose of the Pfizer COVID vaccine. Her mother's doctor doesn't know, nobody knows, if they need to reschedule her second vaccine. The patient  just wanted to know what was right,  Wants to know when her mom can get the second vaccine, if she has to start over. Caller declines to complete safety report. States she has been on hold for 45 minutes and was on hold prior to that with someone else. She stated they took down all of her information and that she just wants to get her question answered and Caller stated she did not have the Lot number from her mom's vaccine as it is with her mom who was not with the caller at this time, declined to provide mailing address and stated that its already been given to previous department she was speaking with. Caller was concerned because her mother will be placed under a 14-day quarantine and she was not sure on how her mother will receive the 2nd vaccine or whether her mother will repeat the entire process of vaccination because her mother was very weak and will still be on quarantine on the 2nd dose vaccination appointment. The outcome of the events was unknown.  Follow-up (30Mar2021): This is a follow-up spontaneous report from a contactable consumer. This consumer reported for a patient (Reporter's mom) that: patient was diagnosed with COVID on 29Mar2021.  Follow-up (30Mar2021): This is a Follow-up spontaneous report from a Pfizer-sponsored program. A contactable consumer reported for a patient (Reporter's mother) new event asthenia.  Information about Batch/Lot number has been requested.
23 days after 1st dose of Moderna, I came down with Shingles. Started with a right-side back ache and developed the rash on my mid spine. Nerve pain developed along right side back and right side ribs and is still ongoing.
Two days after vaccine, around triceps area of left arm, where ZOSTAVAX was given, developed patch of redness, warmth, pain. This worsened overnight and by the third day post vaccine was causing numbness in left hand, swelling in axilla in addition to upper arm and lymphadenopathy in left axilla. She was taking ADVIL and icing the area for treatment.
Exactly 30 days after first vaccine had a stroke. Left frontal infarction. Was hospitalized from May 11 till May 13 2021  Important to note that my mom had the same exact stroke (exact same area of the brain) approx. 30 days after her second dose of Moderna.
severe chest pain; difficultly breathing; chest tightness; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (severe chest pain), DYSPNOEA (difficultly breathing) and CHEST DISCOMFORT (chest tightness) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, the patient experienced DYSPNOEA (difficultly breathing) and CHEST DISCOMFORT (chest tightness). On 06-May-2021, the patient experienced CHEST PAIN (severe chest pain). At the time of the report, CHEST PAIN (severe chest pain), DYSPNOEA (difficultly breathing) and CHEST DISCOMFORT (chest tightness) was resolving. Not Provided          No relevant concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD-2021-046017 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: follow up was received on 06-MAY-2021 which contains event start date.
pt recv vax 7APR97 & it was reported the following day 8APR97 pt exp a gen itching, poss hives on legs & an inj site rxn consisting of a hard, warm, red, tender area;pt called MD who prescribed antihistamine;
PT presented w high fever 104 with secondary hallucinations <24 hrs after administration. Recovered w supportative treatment.
Patient turned 12 years of age since first shot and received a child dose of vaccine instead of age appropriate dose.   Patient mother contacted.
vaccine given below the deltoid muscle and per the patient's mother it was red and hot to the touch Friday evening thru the weekend.  Mother sent pictures at 4 pm today (Monday, 4/26/21),  slightly pink and mother reports that it is no longer hot.  Patient has been active and has not complained of pain or discomfort since the vaccine was given on Friday per the mother.   Clinic doctor prescribed Benadryl be given oral and will see the patient in the morning for a full examination.  Mother was instructed to go to ER if things change or if she spikes a high fever.  Mother voiced understanding.
This spontaneous report as received from a pharmacy technician refers to a 4 year old patient of unknown gender. Patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 09-FEB-2018, the patient was vaccinated with improperly stored dose of VARIVAX (lot # N022979, expiry 23-AUG-2019) for prophylaxis. No adverse effect was reported. The VARIVAX temperature excursion occurred on 14-DEC-2017 and 30-DEC-2017. On 14-DEC-2017, the vaccine was exposed to the temperature of 16.9 degree Fahrenheit (F) for 30 minutes. On 30-DEC-2017, the vaccine was exposed to the temperature of 6 degree Fahrenheit (F) to 14 degree F for 30 minutes. It was reported that the event was because of data logger. No product quality complaint was involved. This is one of the several reports received from the same reporter source. Sender's Comments: US-009507513-1802USA001558.
Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Additional Details: DERMATOLOGIST OKAYED GIVING THE SECOND DOSE
Right shoulder pain continues from time of shot to present. No has migrated to right arm and hand. Tinnitus continues at a level 6/10 and unresolving fatigue. Right subacromial bursitis. Pain has increased since last seen in 2001. Has pain when raises right arm; pain awakens him from sleep if he rolls on affected side, pain includes right hand and 1st finger. Takes no medication. tinnitus-rates intensity at 6/10, which increased immediately after receiving AVA #2.
pain in injection side; cherry angioma; fatigue; muscle weakness; chills; fever; diarrhea; skin rash (urticaria); on day five start of abdominal pain; This is a spontaneous report received from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: EN6205) via an unspecified route of administration in the right arm on 13Mar2021 at 11:30 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history included cholinergic urticaria, lactose and fructose intolerance. The patient's allergic history included rhinitis, animal fur, mites, dust, NSAIDS (Nonsteroidal Anti-Inflammatory Drugs) causes urticaria. The patient did not receive any other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19.  On 18Mar2021, the patient experienced abdominal pain. On 20Mar2021 at 10:00, the patient experienced pain in injection side, fatigue and muscle weakness, chills, fever, diarrhoea, skin rash (urticaria), cherry angioma. Since the vaccination, the patient had been tested negative for COVID-19 on 21Mar2021. As a corrective measure the patient received cetirizine for all the events. The clinical outcomes of the events, pain in injection side, fatigue and muscle weakness, abdominal pain, chills, fever, diarrhoea, skin rash (urticaria), cherry angioma were recovering. No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: Patient's Postal Code added, Verbatim was updated for medical history. Relevant Med History Rhinitis was deleted as it is the reaction of animal fur, mites, dust allergy, Lab data "Rapid Diagnostic RNA test" deleted as it can be combined with PCR (Nasal Swab), Vaccine Facility Information added.
This spontaneous report as received from a licensed nurse practitioner refers to multiple unspecified patients of unknown age and gender. On 01-OCT-2014 the patients were vaccinated with VAQTA (dosing details unknown). The reporter stated that she had a supported temperature excursion that affected VAQTA. Reporter stated that she presumed she had administered to multiple unspecified patients since the first excursion date, on 01-OCT-2014, but had no patient or product specific information to offer. No adverse effects were noted. Outcome of the temperature excursions of VAQTA was unknown. No product quality complaint was involved. This is one of the several cases received from the same reporter. Additional information has been requested.
Headache; soreness at injection site; extreme muscle and joint pain; extreme muscle and joint pain; mild fatigue; This is a spontaneous report received from a contactable consumer (patient). This non-pregnant 18-year-old female patient received the second dose of COVID-19 vaccine (UNSPECIFIED TRADE NAME; lot number EW0153) via an unspecified route of administration in the right arm on 15Apr2021 at 08:15 (at the age of 18-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to vaccination the patient had not been diagnosed with COVID-19. Concomitant medications included sulfamethoxazole, methylphenidate hydrochloride, and sertraline, all from unknown dates for unknown indications. The patient previously received the first dose of COVID-19 vaccine (lot number EP6955) on 25Mar2021 at 08:15 (at the age of 18-years-old) for COVID-19 immunisation. The patient had not received any other vaccines in the four weeks prior to the COVID vaccine. On 15Apr2021 at 16:00 the patient experienced headache, soreness at injection site, extreme muscle and joint pain, and mild fatigue. No treatment was received for the events. The clinical outcomes of headache, soreness at injection site, extreme muscle and joint pain, and mild fatigue were unknown. It was also reported that since vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are needed. No further information is expected.
patient received PENTACEL but did not get the ACT-HIB portion/ no AE; Initial information was received on 23-Aug-2021 regarding an unsolicited valid non-serious case from other health professional and physician via call center via  Medical Information (Reference number- 00736108).  This case involves a 3-month-old male patient who received DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] but did not get the ACT-HIB portion (product preparation issue).  The patient's medical history, past medical treatments, vaccinations and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE POLYSACCH 23V (PNEUMOVAX) and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for prophylactic vaccination.  On 04-Aug-2021, the patient received a 0.5 mL dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (suspension, lot number: UJ465AAA and expiry date: 21-Mar-2021) via an intramuscular route in the right lateral thigh for prophylactic vaccination.  It was an actual medication error case due to inappropriate reconstitution technique (latency: same day).  It was reported "caller is wanting to know what to do."  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 holder's 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.