chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial information received on 29-May-2018 regarding an unsolicited valid non-serious case received from other health professional (Medical assistant). This case involves a 38 years old patient (gender unknown) who received vaccine FLUZONE HIGH DOSE. The patients past medical history, medical treatment, vaccination, concomitant medication and family history were not provided. On an unknown date, the patient received injection of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE, lot UI876AB, expiry date, dose not reported via unknown route in unknown administration site. It was an actual medication error due to inappropriate age at vaccine administration. It was unknown whether patient experienced any adverse reaction after the injection. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the 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. List of documents held by sender- none.
Patient reported to RPh on 12/8/11; that 4-5 months after immunization she reported to MD progressive muscular weakness to the extent she had difficulty walking. Per patient, she was diagnosed: chronic inflammatory demyelinating polyneuropathy.
11/12/2009 patient received first dose of injection H1N1 vaccine; patient had mild cough/cold sxs with fever at time of injection. No local reaction or systemic reaction x 72 hours after vaccine administered. However, 1 wk after vaccine administration patient developed pin-point raised flesh white colored rash with pink skin around them; no pallor locally, no pain, no itching, no edema. (This rash was at the injection site 1 1/2" wide by 2" length area.
This spontaneous report as received from a pharmacist refers to a patient of unknown age (gender not reported). Pertinent medical history, drug reactions or allergies were not reported. On 28-MAY-2014 the patient was vaccinated with improperly stored dose of ZOSTAVAX, lot number: J011548, expiration date: 19-DEC-2014, (dose, route not reported). No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
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 42-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Jan2022 at 14:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 42 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Sjogren's disease" (unspecified if ongoing), notes: Other medical history: Sjogren's disease and non-RA currently unspecified inflammatory arthritis; "non-RA currently unspecified inflammatory arthritis" (unspecified if ongoing), notes: Other medical history:Sjogren's disease and non-RA currently unspecified inflammatory arthritis; "Known allergies: Sulfa drugs" (unspecified if ongoing), notes: Known allergies: Sulfa drugs and cephalosporin antibiotics. The patient took concomitant medications. Past drug history included: Cephalosporin antibiotics, reaction(s): "Known allergies: cephalosporin antibiotics", notes: Known allergies: Sulfa drugs and cephalosporin antibiotics. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  Clinical course: Patient received treatment drug as Paxlcovid from 28Jun2022 to 02Jul2022 for COVID-19. Other medication was in 2weeks Tylenol extra strength from 25Jun2022 to 07Jul2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I saw a patient on 5/16/2021 for her 2nd Shingrix shot who was saying that she was still having pain and difficulty with range of motion from her 1st shingles shot at the beginning of March (March 6th, 2021). I apologized, assessed her and consulted with my consulting physician who recommended we give the 2nd Shingrix vaccine, advise Tylenol and cold compresses for comfort, and that she follow up with her PCP. During assessment, pt was unable to move her left arm behind her back without pain. She states that the pain radiates to her upper back and her left side of her neck from the injection site which she states she thinks was placed too low. She was able to raise arms above her head and in front of her body without pain.
abdominal stomach pains; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (abdominal stomach pains) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 22-Mar-2021 at 10:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Mar-2021 at 6:00 PM, the patient experienced ABDOMINAL PAIN UPPER (abdominal stomach pains). At the time of the report, ABDOMINAL PAIN UPPER (abdominal stomach pains) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment information was provided.  Very limited information regarding this event/s has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
We can not fall asleep; we were not sleepy; we were awake all night; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 90-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Nov2022 as dose 3 (booster), single (Lot number: GH9697) at the age of 90 years for covid-19 immunisation. The patient's relevant medical history included: "Blood pressure high" (unspecified if ongoing); "Glaucoma" (unspecified if ongoing). Concomitant medication(s) included: CANDESARTAN [CANDESARTAN CILEXETIL] taken for hypertension. Vaccination history included: flu shot, administration date: 07Oct2022, when the patient was 90-year-old, for Immunization; Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for Covid-19 immunization. The following information was reported: POOR QUALITY SLEEP (non-serious) with onset 11Nov2022, outcome "unknown", described as "We can not fall asleep; we were not sleepy; we were awake all night". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Reporter stated that, he just wants to report and sort of curious. He could not find anything on the computer about side effects and one that he would like to pursue was ability to fall asleep. Last night, his wife and he had some time and they haven't had their third booster yet, so they had the first two and now they wanted to get the third one for the Pfizer. So, they made an appointment at pharmacy for 7:15 and 7:30 and went there and they both had shots. They did not see the shot getting drawn up out of the bottle it came already in syringe and they asked him if it came from a bottle and he said yes and he didn't get about 6 of the bottles (Further not clarified, hence event captured as per the verbatim) and that's what they knew about it. He did not see if it came from refrigeration or anything. He didn't particularly want that kind of shot because those often to have a protection called some kind of a, he did not know the word. Basically, they could not fall asleep. He and his wife had this shot, they were awake all night. She had a very little high blood pressure, its only 132 extremely not high but she took a tremendous number of ocular medications, her problem was Glaucoma.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201300388 Same product/event; different patient;
Itchy rash on neck, bilateral eye swelling, redness below left eye, swelling on skin next to inner canthus.
Severe rash under all undergarments, neck,  all around lower bra area, more severe in back . Also around waist upper legs, wrist area, behind ears, forehead, and hairline. Severe itching, burning and stinging like hives  99.3 degree fever. Blood pressure144/70
my arm was sore.; This is a spontaneous report from a contactable consumer or other non-health care professional. A 73-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EM9810), dose 1 via an unspecified route of administration, administered in Arm Left on 04Feb2021 16:00 as dose 1, single (age at vaccination 73-year-old) for covid-19 immunization. Medical history included none. There were no concomitant medications. The patient did not take prior Vaccinations (within 4 weeks). On04Feb2021, the patient experienced my arm was sore. It was reported that, "They gave me the shot, 15 minutes later I went to the car and my arm was sore. That night the pain went down to my elbow, it is tender down there, during the night when I was asleep my whole arm hurts, I cannot lift, cannot make twist motion, anything. It's just painful." They had the shot for Pfizer's COVID 19 vaccine and his wife has had trouble with her arm since the shot last Thursday, she can't pick up anything or pull without hurting. Patient stayed for 15 minutes fine, her arm didn't hurt, she left and got in the car, that day, she couldn't say what time, her arm started hurting, to lift, she thought it was no big deal, and it seems to be getting worse. She sleeps and rolls over and goes to lift her arm and it wakes her. It's just, she would probably think it was the weather, if not for when it started, it's really cold now, but it's not the weather. States it didn't hurt at all. She felt it going in and when it started and the 15 minutes until the timer went off, she was fine. She has not been to the doctor in quite a while and is fine. This has been a long time, she thought it would stop, it is not getting better, it's more annoying, it does hurt, only when she moves or lifts her purse or something or goes to pull up her pants. The patient was scheduled for second dose 24Feb2021. The patient underwent lab tests and procedures which included weight: 117-120 lbs on an unknown date. The outcome for event was not recovered.   Follow-up attempts completed. No further information expected.
Chills started at 1730, day of vaccine.  Fever of 100.2 at 2100. Tylenol taken.  Fever Returned at 0315 on 12/21/2020. Tylenol taken once more.  Woke up with fatigue and mild fever at 0845 on 12/21/2020 of 99.9. Tylenol taken once more. Chills and fatigue through out the entire day of 12/21/2020.
Patient called and reported redness and a knot at injection site. Also states that it feels warm.
Woke up at 3:30 am from period cramps. Went to the bathroom as this was the start of my period and I didn?t have a pad on. After going to the bathroom I was washing my hands and became nauseous which I have never experienced on my period. I became lightheaded, cold sweats and vomited bile. I have good reason to believe the  vomiting was not due to my period because I have never vomited  due to my period. I took peptobismol for the nausea and ibuprofen for the pain and then went to sleep.
Severe coughing; SOB; Fever 102; malaise; weakness; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 17-year-old male patient received BNT162b2 (BNT162B2), on 06May2022 at 17:45 as dose 3 (booster), single (Lot number: FK9893) at the age of 17 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Covid-19" (unspecified if ongoing), notes: If Covid prior vaccination: Yes. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Single; Manufacturer Unknown, Batch/Lot No: EW0185), for Covid-19 Immunization; Covid-19 vaccine (Dose 2, Single; Manufacturer Unknown, Batch/Lot No: Unknown/Unable to locate or read the details, Location of injection: Arm Left), for Covid-19 immunization. The following information was reported: PYREXIA (non-serious) with onset 07May2022 at 05:00, outcome "unknown", described as "Fever 102"; DYSPNOEA (non-serious) with onset 07May2022 at 05:00, outcome "unknown", described as "SOB"; COUGH (non-serious) with onset 07May2022 at 05:00, outcome "unknown", described as "Severe coughing"; MALAISE (non-serious) with onset 07May2022 at 05:00, outcome "unknown"; ASTHENIA (non-serious) with onset 07May2022 at 05:00, outcome "unknown", described as "weakness". The events "severe coughing", "sob", "fever 102", "malaise" and "weakness" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of cough, dyspnoea, pyrexia, malaise, asthenia.  Additional information: If other vaccine in four weeks: No. If Covid prior vaccination: Yes. If Covid tested post vaccination: No.  No follow-up attempts are possible. No further information is expected.
At injection site: red in color, swollen, hot to touch and painful. Treatment: Cefdinir 3 mL BID x10 days.
This is a serious spontaneous case, initially received from a 53-year-old adult, female patient on 31-Jan-2018. The patient's current condition included thyroid cancer, high blood pressure, asthma and indigestion (since an unspecified date). The concomitant medications included SYNTHROID, COZAAR and loratadine for unknown condition, ZANTAC for indigestion, ADVAIR and albuterol for asthma (on an unspecified date). On unspecified date in 2017 (reported as, in Jan or Feb), the patient was administered with influenza vaccine, (route of administration, intramuscular, anatomical location: right arm, dose, batch number and expiry date: not reported). On the same day of vaccination, in the evening, the patient developed flu and fever. She was treated with TYLENOL OTC and MOTRIN 800 mg. The patient felt better after 2 days. At the time of the report, the patient had recovered from the events.
Developed sx of wheezing, headache, nasal congestion w/in 2-3 hrs of INFLUENZA vaccine. No fever. H/o asthma - no formal testing - uses albuterol inhaler from recent ER visit.
Myocarditis with onset 7/12, worse on 7/13 and admitted to hospital to Cardiology service.   Had non-sustained ventricular tachycardia and was transferred to the cardiac ICU on 7/14 morning and placed on a lidocaine drip.  He had no further arrhythmia, and lidocaine was stopped and transferred out of CICU on 7/15.
Patient called pharmacy today 11/28/17 to report that her left arm, hand and elbow to top, including shoulder and part of the back and left breast had swelling and pain a couple of hours after the vaccine. Redness was mainly limited to site of injection. Those symptoms continued for 1 week according to patient. She was advised to report to MD as well. Patient is feeling well now and symptoms have improved.
This spontaneous case reported by a consumer, describes the occurrence of  discomfort, dysstasia (unable to stand for 8 hours like she used to for work), pain, arthralgia (gnawing feeling on hip) and chills in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. The occurrence of additional events detailed below. No medical history reported. February 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19  vaccine), unknown route; 1 dosage form. March 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. March 2021, patient experienced discomfort, dysstasia (unable to stand for 8 hours like she used to for work), pain, arthralgia (gnawing feeling on hip), chills, fatigue (tiredness), nausea and headache. For the adverse events, patient treated with Advil (ibuprofen) at an unspecified dose and frequency; Aleve (naproxen sodium) at an unspecified dose and frequency; and physical therapy for arthralgia. At the time of the report, discomfort, dysstasia (unable to stand for 8 hours like she used to for work), pain and arthralgia (gnawing feeling on hip): not resolved; and chills, fatigue (tiredness), nausea and headache: resolved. Most symptoms went away by the following Sunday. Patient visited her doctor in May who ordered X-rays and referred her to a specialist. The specialist ordered 12 sessions of physical therapy, which seemed to help her knees. Patient's hips have continued to feel horrible, and worse on the right-side. Patient has been active the last 14 years without pain, but had pain this year. She has been taking Advil and Aleve for her symptoms.
Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 56-year-old female patient 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) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  It was reported that patient's facility was unable to download the digital data logger, they would need to treat this issue as a temperature excursion. The data logger that caller was unable to download were for the months of Dec-2021, Jan-2022, and Feb-2022. The reporter also stated that no adverse reactions were reported by any patients.  Treatment information was not provided.
Mom states child developed fever 105R @ approx 11PM on day of immun; Fever up & down all night, APAP helped; To ER following morning w/t104R & vomiting;  S&S gone by that evening; MD state reacted to Pertussis vax;
presenting symptoms of Covid/she received the vaccine a couple of days ago; This is a spontaneous report from a contactable pharmacist reported that a 57-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number was not reported), via an unspecified route of administration on Apr2021 as a single dose for covid-19 immunisation. The patient medical history included chronic obstructive pulmonary disease (COPD) from an unknown date and was a frequent flyer with her exacerbations. The patient's concomitant medications were not reported. The reporter stated that the patient was now presenting symptoms of Covid and the physician wanted to give monoclonal antibodies. The reporter asked if that was okay or if there was a time limit that she needed to wait to receive them since she received the vaccine a couple of days ago. The outcome of presenting symptoms of Covid was unknown. The pharmacist does not believed that the patient received it from the vaccine.   Information on the lot/batch number has been requested.; Sender's Comments: Considering the mode of transmission (respiratory droplet transmission) and current pandemic situation, the reported event COVID 19 is considered as not related to  BNT162B2 vaccine.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
After 1st day, reactions rash, itching on face, arms and legs since Oct 20th 2006. Pt went to see doctor on 11/08/06 but talked to MD on 10/20/06 and got Prednisone on 10/27/06.
I received my second Moderna booster for COVID-19 on 4/14/2022. On 5/24/2022, I was informed that my daughter had just tested positive, and I had recently spent time with her. Because of that, I became more vigilant when looking for possible symptoms of COVID-19. While I was working out on 5/26/2022, I had to use my albuterol rescue inhaler; I have asthma, but I still don't often have to use it. I took a home test on both 5/26/2022 and 5/27/2022, and I got a negative result both times. On 5/28/2022, I developed a headache, scratchy throat, and runny nose. I took another home test, and this time I got a positive result. It was basically like a normal head cold, and I had the symptoms for about 4 days. During this time, I also stepped up the strength level on my DULERA inhaler. I kept a close eye on my oxygen saturation levels, and they never dropped below 93%. I asked my doctor if I should take PAXLOVID, but he didn't think I did. I just treated my symptoms with MUCINEX DM, NASACORT, TYLENOL, and my DULERA inhaler. Overall, the symptoms were not severe, though even now I fatigue a bit more easily and don't bounce back as quickly after a workout as I did before the COVID-19.
on 2/6/2014 12 noon - Patient reported that the night of the PPSV injection he felt a "knot" in his (L) deltoid, (+) pain (L) arm pit. Stretched with a towel - hard a "pop". Know went away then noticed a red area upper (L) arm 50 cent size toward armpit. (+) muscle soreness. Took TYLENOL/Ibuprofen d/t wisdom teeth coming in. Noted 50 cent size nonraised red area. Denied itching, (+) muscle soreness between (L) delt and axilla - no redness at injection site. Advised to continue TYLENOL/Ibuprofen. Take BENADRYL and see me next day. On 2/7/14 04:30 muscle soreness gone - unless touch area or move a certain way. Color faded almost completely away even without taking BENADRYL ("BENADRYL makes me sleep too much").
headace/pressure on right side of head/jaw bone; blister on upper lip; rash on left side forehead; chills; mouth tastes weird; achey.
Body felt like it was on fire.  Pain everywhere but also very focused in areas of previous injuries, rotator cuff, knee, hand.  Muscle twitches that turned to convulsions and unstoppable shaking.