chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a pharmacist and refers to a female patient of unknown age. The patient's pertinent medical history, drug reactions, allergies and concomitant mediations were not reported. On 22-JUN-2017, the patient was vaccinated with a dose of PNEUMOVAX 23 lot # M027552, expiration date 04-FEB-2018 (dose and route of administration were not reported). On 23-JUN-2017, she was seen at an unspecified urgent care facility for redness and soreness at the injection site and fever (onset date on an unknown date in June 2017). The patient was given a "Zpack" at the urgent care as treatment. The patient went to her primary care doctor on the same day as her urgent care visit and was given aspirin (manufacturer unknown) tablet, orally (strength, dose, frequency, indication, lot# and expiration date were not reported). On 24-JUN-2017, the patient's primary care doctor prescribed the patient cephalexin. On 25-JUN-2017, the patient was seen at an unspecified Emergency Room and prescribed a higher dose of cephalexin and also prescribed BACTRIM. The pharmacist stated that on 28-JUN-2017, the patient's primary care physician prescribed a higher dose of BACTRIM. The pharmacist stated that on 02-JUL-2017, the patient was prescribed VALTREX. On an unknown date in 2017, the patient was diagnosed with cellulitis. The outcome of the events was not provided. The relatedness between the events and the suspect medication was not reported. Upon internal review, the event of cellulitis was determined to be medically significant. This is one of several cases received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1707USA005526.
temperature excursion with AE; No adverse event; Temperature excursion; This spontaneous case was reported by a consumer and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursion with AE) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 066H22A) for COVID-19 prophylaxis.     It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     In March 2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In March 2023, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursion with AE) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursion with AE) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursion with AE).    Concomitant medication was not provided.  It was reported that lost power the next day in the middle of the day at 12:00 PM and placed all vaccine into a frozen bag. Booster vaccines were then transported to another clinic.  Treatment information was not provided.  This case contains information for the 25th patient out of 26 adult patients as described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-718370 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-718370:Master case
Vaccine was not reconstituted properly and patient received only diluent/adjuvent.  Patient stated that she was having right hip pain.
Information has been received from a physician concerning a 4 month old female who was vaccinated with a first dose in her fourth month and second dose in her fifth month of ROTATEQ. Two weeks after each dose the patient developed a colicky fussing for one week. Subsequently the patient recovered. There was no product quality complaint involved. Additional information has been requested. This is in follow-up to report (s) previously submitted on 11/14/2006.  Information has been received from a physician concerning a 4 month old female with no medical history or allergies who was vaccinated PO on 07-AUG-2006 with a first dose in her fourth month and on 05-SEP-2006 with a second dose in her fifth month of ROTATEQ (lot # 654504/0695F).  Concomitant vaccination administered on 07-AUG-2006 included an IM second dose in the right thigh of PEDIARIX (lot # AC12B066AA), an IM second dose in the right thigh of ACTHIB (lot # UE914AA) and an IM second dose in the right thigh of PREVNAR (lot # B00655K).  At the time of vaccination on 07-AUG-2006 the patient had a temperature of 100.5.  Two weeks after each dose the patient developed a colicky fussing for one weekMedical attention was not sought.  Subsequently the patient recovered.  There was no product quality complaint involved.  Additional information is not expected.
Had shingles, flu and pneumonia vaccines. That afternoon got a massive headache, 101 temperature, chills, aches, vomiting cannot keep water down for two days. Next day. Headache and sight of injection the arm went into spasms and sharp pains. Next day: Skin is stinging on face and have very sore throat. Today: Still have stinging but moved to top of my head. Painful to touch. Developed a blister on lip with what appeared to be a puslike substance in middle. (I have never had cold sores before). Very exhausted still. Have read on line some people having same reaction as me.
PAIN IN ANKLE; VACCINATION SITE PAIN; This spontaneous report received from a patient concerned a 51 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included torn meniscus, lupus, and psoriatic arthritis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported, expiry: unknown) dose was not reported, 1 total administered on 07-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported, expiry: unknown) dose, frequency, and therapy dates were not reported for psoriatic arthritis. No concomitant medications were reported. On an unspecified date, the patient experienced pain in ankle, and vaccination site pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable and action taken with adalimumab was not reported. The outcome of the pain in ankle and vaccination site pain was not reported. This report was non-serious. This case, from the same reporter is linked to 20220249334.
Had TRUMENBA and Hep A Friday at 10:30AM. Friday night began vomiting at 10PM vomited x3; diarrhea began at 10PM and 2-3 episodes Fri PM, Sat and Sun. Today (Monday) no vomiting/diarrhea but nauseous. Chilled; no temp. No meds or treatment. Was treated - still taking meds for a UTI dx 01/28/16.
This spontaneous report as received from a registered nurse. The nurse reported on unknown date, multiple unspecified patients were administered VAQTA that were stored improperly. No adverse effects reported. This is one of several reports received from same source. Additional information has been requested.
This case was considered medically important (OMIC). Information regarding Hib-Titer vaccine was received from a consumer regarding a 17 month old male patient who, at 12 months of age, on 11/4/02, received a fourth dose of Hib-Titer. On the same day, the patient also received a third dose of hepatitis B vaccine. In April 2003, the patient developed autism. No significant medical history or conditions. Indication for Hib-Titer vaccine was immunization. Product was administered on 11/4/02. Dose regimen was 1 dose (IM). Additional suspect vaccines included Polio Vaccine, Acel-Imune Vaccine and hepatitis B vaccine. Concomitant medications were not reported. On 11/4/02, the patient received a fourth dose of Hib-Titer vaccine, and in April 2003, developed autism. The patient's outcome is unknown. No additional information was available at the time of this report.
Head ache, body ache both fairly severe. Fever above 101 for 2 days (104.5 at highest). Redness, swelling and very sore around YF/PNEUMOVAX injection sites over most of upper arm.
Vomited; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (Vomited) and DIARRHOEA in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, the patient experienced VOMITING (Vomited) and DIARRHOEA. At the time of the report, VOMITING (Vomited) and DIARRHOEA outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided. No treatment was reported.
Miscarriage confirmed on 3/23/2021 at approximately 5 weeks and 6 days.
Symmetrical red rash on both upper, inner thighs. Fever of 99-101?F
Rash broke out on mainly left arm some on left arm spot leg. Itches and burns also.
Started feeling a faint, dull, continuous ache in my chest and back. Woke up, got ready for work, went to work (2nd shift), but the ache increased, and every now and then, I felt sharp pangs in my chest. I left work 2 hrs early and drove myself to the ER. I had experienced milder versions of this pain before during the three times I?ve had Covid, and after the second and third Pfizer shots. The pain after this 4th Pfizer shot has been much stronger and longer-lasting. The ER prescribed 800 mg of ibuprofen and 0.6 mg colchicine, but I still have uncomfortable moments where I wonder if it will become a heart attack. Apparently it can take a couple weeks before there?s improvement in symptoms.
got reallysick; Initial information regarding an unsolicited valid non-serious case received from a consumer (patient) via social media on 06-Dec-2020.  This case involves a patient of unknown demographics who got really sick (Illness), while the patient received Influenza Vaccine.  Patient had medical history of compromised immune system..  The patient's medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was unknown.  On an unknown date, the patients received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number not reported) via unknown route in unknown administration site as prophylactic vaccination.  On an unknown date, the patient got really sick (Illness), unknown latency after the patient got the shot.  It was not reported if the patient received a corrective treatment. Outcome of the event was unknown, at the time of reporting. There will be no information available on the batch number for this case.
Head Ache, fever and chills. Injection site red and extremely sore. Very uncomfortable. Unable to sleep.
Patient given expired Moderna COVID 19 vaccine. Vaccine expired on 9/26/2021 and was given on 9/27/2021. There were no immediate adverse signs or symptoms from this vaccine error.
Can see the lump or clotting on the left hand at the spot of injection and been seeing a big red spot ( approximate diameter of 2-2.5 inches). Also can feel a pain in the left hand
Hospitalized 3/26/21 for GI symptoms not associated with a COVID infection. Found to have an abdominal mass. Discharged 3/29/21
Swelling at site, pain at site, respiratory issues, congestion, coughing, ear infection, sinus infection.
An expired vaccine was given. Apparently the vaccine expired 03/23/2022 and was given on 09/22/22. Patient is suffered no adverse reactions.
Vertigo attack, tinnitus, headache, fatigue, joint swelling of hands, joint pain body wide,
I ended up having a grand mall seizure; Severe migraine; I then had a fever; This is a spontaneous report from a contactable consumer (patient). A 51-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (at the age of 51-years-old), dose 2 via an unspecified route of administration, administered in arm left on 04Jun2021 16:00 (Batch/Lot Number: EW 0178) as DOSE 2, SINGLE for COVID-19 immunisation. The patient's medical history included known allergies (unspecified) and seizure disorder. The patient's concomitant medications were not reported. The patient previously took BNT162B2 (at the age of 51-years-old) dose 1 administered in arm left on 28Apr2021 12:00 PM (Batch/Lot Number: EW0176) for COVID-19 immunisation. The patient was not pregnant. She had no other vaccine in four weeks. She had no covid prior vaccination. She had not been covid tested post vaccination. The patient experienced severe migraine and then she ended up having a grand mall seizure and this was actually about 4-4 1/2 hours after she had her second COVID19 vaccination done. She then had a fever that lasted about two and a half days before it broke. Granted she does have a seizure disorder and she wasn't too surprised about having a seizure, however she usually have at least a couple of seconds that she saw stars and she knew that she was going to have one but she was standing up and she had no idea it was happening. The events occurred on 04Jun2021 at 08:00 PM. The events resulted to doctor or other healthcare professional office/clinic visit. The patient recovered from the events with lasting effects. She mentioned that X-Rays were done with unknown results on an unspecified date to make sure that she didn't have. Therapeutic measures were taken as a result of the events. The outcome of grand mall seizure and severe migraine was recovered with sequelae on an unspecified date while fever was recovered on an unspecified date.
A 59 year old patient received Fluzone HD with no reported adverse event; A 59 year old patient received Fluzone HD with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from other health care professional via a consumer/non-health care professional via Medical Information (GMI) (Reference number- 00819379) and transmitted to Sanofi on 19-Oct-2021 in .  This case involves a 59 year old female patient who was received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (product administered to patient of inappropriate age and overdose).  The patient's medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On 04-Oct-2021, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (batch number and expiry not reported) via unknown route in unknown administration site for prophylactic vaccination.  It was a case of an actual medication error due to inappropriate age at vaccine administration and overdose (latency same day).  It was reported "The sales representative is reporting potential adverse event (AE) information she was made aware of by the Certified Medical Assistant (CMA) lead. The sales representative would like to know if there is a form she can e-mail in or is this the appropriate way to report a potential AE. The sales representative is reporting that the CMA lead reported to her that a 59-year-old female patient received Fluzone high dose (HD) on 04Oct2021. She states that she was asked a couple questions that she didn't answer but these are all the facts she was given."  No other 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 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.  There will be no information available on the batch number for this case.
Date of Admission: 10/19/2022.   Date of Discharge: 10/24/2022.   Admission Diagnosis: COVID-19  Atrial fibrillation with rapid ventricular response
10 mins after vaccine given, pt complained of blurred vision, dizziness and increased sweating. Called pt's PCP and she said to check pt's bp and see if the pt wanted to go to a walk in clinic.
OFF LABEL DOSING FREQUENCY; This spontaneous report received from a patient concerned a patient of unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: polyethylene glycol allergy. The patient was previously treated with 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, 1 total administrated, start therapy date were not reported for covid-19 prophylaxis. No adverse events reported following vaccination (dose number in series 1). The patient received of first booster dose covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total administrated, start therapy date were not reported for covid-19 prophylaxis. No adverse events reported following vaccination (dose number in series 2). The patient received of second booster dose covid-19 vaccine ad26.cov2.s (dose number in series 3) (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total administrated, start therapy date were not reported for covid-19 prophylaxis. The drug was associated with Off label use. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced off label dosing frequency (dose number in series 3). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of off label dosing frequency was not reported. This report was non-serious.
Patient reports eye burning, eyelid swelling, eye watering, and difficultly keeping the eye open. Patient had to go to eye doctor and was informed that her right eye is inflamed.
Left arm is swollen, rash is painful and itching and underarm is painful as well.
Full body swelling, gastrointestinal distress,diarrhea, vomiting, shortness of breath, swelled face and neck. Used diphenhydramine and an epi pen to stop swelling. Lost feeling in left arm and proceeded to Lose feeling in both hands and feet for 48 hours. Difficulty walking due to no feet for 48 hours.
Patient notified RN that she was feeling itchy on her arms, trunk and legs. No hives or welts present. Redness noted due to patient scratching.  We gave her ice packs and 50 mg of Benadryl orally. She stated she had no known drug allergies and had taken Benadryl in the past. RN staff advised patient should remain for longer monitoring. patient declined more monitoring following initial 15 min wait time. She said the ice packs and Benadryl were sufficient and she would go to ER if symptoms worsened. Also advised to speak to PCP regarding second dose.
Pt called at 8:10pm and complained of Dizziness, Nausea, and overall not feeling well. Recommended 50mg of benadryl at 8:15pm.  Called Pt back at 8:55pm to check on Pt. Pt complained of a Tingling sensation in leg but not feeling any worse.  No Hives reported, Throat and Breathing was alryght.  Pt was recommended to monitor his condition and if condition worsened, to seek medical attention
Pain in right arm top of shoulder joint to about 4 inches down arm; range of motion not affected; no treatment or visit to PMD as of the time of this report.
Information has been received from a nurse practitioner concerning a 64 year old male with a bupropion hydrochloride (WELLBUTRIN) allergy, who on 06-DEC-2005 was vaccinated subcutaneously into the left arm with a 0.5 ml first dose of pneumococcal 23v polysaccharide vaccine (lot#649697/1038P).  Within hours, the patient experienced an injection site reaction to include pain, redness, swelling and local heat all the way to the elbow.  It was noted that to was hard for the patient to move his arm due to the pain.  The pain was treated with amoxicillin (+0 clavulanate potassium (AUGMENTIN), twice a day for 7 days.  There were no laboratory diagnostic studies performed.  Within one week, the patient recovered.  Additional information is not expected.
A day after both vaccinations, in addition to the known side effect (tiredness, headache, muscle soreness), I felt a tingling sensation in my fingers and toes, similar to the pins and needles sensation after restricting blood flow to your foot, but duller and slower. When I felt better enough to start exercising again, I noticed pain in my hip joints after 30 minutes of walking, and my toes easily blister. After 1 hour of walking, it is normal for that to result in 4-8 blisters total for both feet. Most of the blisters are on my toes, but occasionally I'll get one on the ball, arch, or heel of my foot. The blisters are larger than any I have gotten in the past. I normally lance them to drain the fluid and wait a day before walking again. They are not a big deal, just painful and limit my back to back daily activity. It is 4 months after vaccination, they are getting less frequent, but still are a concern.
The muscles in my legs are tight, it feels like when I had the flew last month; It's an achy pain; pain at the injection site; This spontaneous case was reported by an other health care professional and describes the occurrence of MUSCLE TIGHTNESS (The muscles in my legs are tight, it feels like when I had the flew last month), MYALGIA (It's an achy pain) and INJECTION SITE PAIN (pain at the injection site) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Sep-2021, the patient experienced MUSCLE TIGHTNESS (The muscles in my legs are tight, it feels like when I had the flew last month), MYALGIA (It's an achy pain) and INJECTION SITE PAIN (pain at the injection site). At the time of the report, MUSCLE TIGHTNESS (The muscles in my legs are tight, it feels like when I had the flew last month), MYALGIA (It's an achy pain) and INJECTION SITE PAIN (pain at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) 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. Treatment information was not provided.
Migraines dizzinees and pulsatile tinitus developed 2nd day after receiving 2cnd Moderna Covid vaccination.  Been to ENT twice. Had hearing test showed signs of hearing loss in left year. Been on high dose prednisone for 2 weeks. MRI without contrast done on June 17th. I still experience pulsatile tinnitus migraines and dizziness as of this date.