chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Physician). 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 22Sep2022 at 14:30 as dose 5 (booster), single (Lot number: GH9693) at the age of 65 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), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Type I diabetes" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid from 17Mar2023 to 21Mar2023.; Sender's Comments: Based on available information, a lack of efficacy with the suspect vaccine BNT162B2 in this patient cannot be completely excluded.
I thought I was experiencing a sinus infection because I had a sore throat. I was coughing, having a headache, and my nasal passage was congested. I had started taking ADVIL sinus medication and it helped a little bit but it started progressing. I called my PCP first and they said they don't do the throat swab, so I needed to go the urgent care or ER. So, I went to the urgent care not far from my house. They asked me about my symptoms, and I told them and they asked if I wanted to get a COVID test while I was there. They tested me and it came back positive. They did another COVID test and sent it to the lab and it would take 3 days to make sure. (PCR) They wanted to verify that it was positive again. They gave me digital COVID-19 results. That also came back positive the next day. He gave me a prescription for PAXLOVID. I asked about a prescription for the cough since I was still coughing. He prescribed Benzonatate and I've been taking those. Benzonatate 3 times a day and PAXLOVID twice daily one in the morning and in the evening. Planning to go get retested this coming Friday.
Patient experienced dizziness, headache, nausea, muscle aches.  Patient went to Urgent Care and was diagnosed with vertigo.
Patient was only eleven years old and received Pfizer vaccine approved for ages 12 and older.
Johnson and Johnson vaccine as my second dose; Hives/ hives came back a little bit / Developed welts in the mouth; Spider bite like reaction; Developed rashes on the body and stomach; This spontaneous case was reported by a consumer and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Johnson and Johnson vaccine as my second dose), URTICARIA (Hives/ hives came back a little bit / Developed welts in the mouth), VACCINATION SITE REACTION (Spider bite like reaction) and RASH (Developed rashes on the body and stomach) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ATENOLOL, WARFARIN, IRBESARTAN and SIMVASTATIN for an unknown indication.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced URTICARIA (Hives/ hives came back a little bit / Developed welts in the mouth), VACCINATION SITE REACTION (Spider bite like reaction) and RASH (Developed rashes on the body and stomach). On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Johnson and Johnson vaccine as my second dose). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Hives, at a dose of 1 dosage form once a day. At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (Johnson and Johnson vaccine as my second dose) had resolved and URTICARIA (Hives/ hives came back a little bit / Developed welts in the mouth), VACCINATION SITE REACTION (Spider bite like reaction) and RASH (Developed rashes on the body and stomach) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       Patient took Johnson and Johnson as the second dose.   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: Follow up received on 05-May-2021 contains significant information about second dose of vaccine and treatment drug information updated. On 21-Jun-2021: Follow-up information received on 21-Jun-2021 contains non-significant information.
Patient received 1st dose of Pfizer on 4/17/21 and then received a 2nd dose of Moderna 20 days later on 5/7/21.
cold chain break is reported with no reported adverse event; Poor quality vaccine administered/excursion vaccine was administered with no reported adverse event ,; Initial information received on 19-Apr-2023 regarding an unsolicited valid non-serious case received from a physician.  This case is linked to cases 2023SA124713 and 2023SA129811.  This case involves Infant and unknown gender patient for whom poor quality vaccine HIB (PRP/T) vaccine [ACT-HIB] administered of which cold chain break with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It is unknown if the patient had any medical history, concomitant disease or risk factor.   On an unknown date the cold chain break is reported with no reported adverse event (product storage error) and patient received a dose of suspect HIB (PRP/T) vaccine powder and solvent for solution for injection with unknown strength, dose, batch number, expiry date via unknown route in unknown administration site for prophylactic vaccination was administered with no reported adverse event (poor quality product administered) (latency: same day).  It is unknown if the patient experienced any additional symptoms/events.   It is unknown if there were lab data/results available.   Action taken: not applicable.  At time of reporting, the outcome was Unknown for both the events.   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 guidelines. 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.
chest discomfort; and shortness of breath 2 months; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (chest discomfort) and DYSPNOEA (and shortness of breath 2 months) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 2 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CHEST DISCOMFORT (chest discomfort) and DYSPNOEA (and shortness of breath 2 months). At the time of the report, CHEST DISCOMFORT (chest discomfort) and DYSPNOEA (and shortness of breath 2 months) outcome was unknown.            Treatment medication was not provided
Redness, swelling and itching that came on 9 days after she was given the shot.  We read on her information sheet that we needed to contact someone if this happened after 24 hours so she is concerned.
Varicella and MMR given within 30 days of pt finding out she was pregnant.
Pt received vaccine in LD. 4 hours later developed severe pain, swelling, redness and soreness moving left arm for several days.
Face swelling/congestion,  lymphnodes under my under arm breast left side, right arm nodes at elbow, left neck and sores in mouth. Earpain, inflamation, hard to hear on right ear and vertigo in both ears. vomiting, Visited urgent care on 9/28/2021 prescribed antibiotic, prednisone and meclazine for dizzy/motion sickness. I still have symptoms and follow up visit is on October 15, 2021.
1942 Sat in monitoring area. 1950 Reported shivering. Blood Pressure 164/73. Pulse 84. Respirations 20. Pulse ox 99% room air. Reported blurred vision, mild nausea.  2020 Code 10 called. 2023 Blood Pressure 154/65. Pulse 86, Respirations 20, Oxygen saturation 100% room air
Pt had a headache & was sleepy. Pt had a T 103 later in the evening - MOTRIN brought it down - pt. had a fever today plus headache & fatigue T101-102 today MOTRIN gave relief.
chest pain; arm pain; sinus infection; anxiety; depression; panic attacks; severe mental illness; enlarged lymph nodes; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (chest pain), PAIN IN EXTREMITY (arm pain), SINUSITIS (sinus infection), ANXIETY (anxiety) and DEPRESSION (depression) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007c21a) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Ear infection, Throat infection and Hives.   On 20-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Sep-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Jul-2021, the patient experienced CHEST PAIN (chest pain), PAIN IN EXTREMITY (arm pain), SINUSITIS (sinus infection), ANXIETY (anxiety), DEPRESSION (depression), PANIC ATTACK (panic attacks), MENTAL DISORDER (severe mental illness) and LYMPHADENOPATHY (enlarged lymph nodes). At the time of the report, CHEST PAIN (chest pain), PAIN IN EXTREMITY (arm pain), SINUSITIS (sinus infection), ANXIETY (anxiety), DEPRESSION (depression), PANIC ATTACK (panic attacks), MENTAL DISORDER (severe mental illness) and LYMPHADENOPATHY (enlarged lymph nodes) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not reported.  Chest pain arm pain and sinus infection for 1 year straight with 2 sinus surgeries enlarged lymph nodes increased anxiety and depression panic attacks severe mental illness It was unknown if the patient experienced any additional symptoms/events. Patient was on antibiotics and steroids. Lab data was not reported.
Initial and follow-up information has been received from a 78 year old female with irritable bowel syndrome, hypertension, peripheral neuropathy, IVP dye allergy and severe stomach nausea, pain and vomiting with many different prescription pain medicines and antibiotics and a history of two lumbar spinal fusion surgeries who on 24-APR-2007 was vaccinated with a single dose of ZOSTAVAX. Concomitant therapy included ACTONEL, FLONASE, ALTACE, TOPROL XL TABLETS, meprobamate, CLIMARA AND amitriptyline HCL/ clordiazepoxide. On 27-APR-2007 the patient experienced stomach aches and nausea, itching and small rashes on her back, and headaches. She also said that at times she has felt achy all over but she has not had a fever. At the time of the initial report medical attention was not sought. In follow-up it was noted that a pathologist thought the patient's reactions were related to Zostavax. There were no lab tests performed. At the time of the report the patient was recovering, though it was noted that the rash on her back only lasted a few days after treatment with hydrocortisone cream. There was no product quality complaint involved. No further information was provided. Additional information has been requested.  Follow up received 03/27/2009.  Additional information is not expected.
Excessive irritability with unconsolable crying for 4 hours, acetaminophen was recommended
Shaky, dizzy, diaphoretic, lips bluish around mouth. Eyes, nose white then suddenly turned gray. Cold and clammy. BP 73/53, blood sugar 178. Slurred speech and staggering walk.
Extreme dizziness - started on 1/27/2021, usually when standing. Seems to fade through the day, except on 2/8/2021, nausea led to dizziness that lasted +2 hours.  High heartbeat - 139 bpm on 1/31/2021, combined with extreme dizziness after getting out of bed.  Heart rate decreased to 107 bpm after 5 minutes of deep breathing exercises.
Initial case was received from a healthcare professional on 08 May 2013. A six-month-old female patient, who had no illness at time of vaccination and no known allergies, received dose one of an injection of FLUZONE, sanofi pasteur Inc., lot number U4547CA, (route, site and side not reported) on Friday, 03 May 2013. The patient started to experience vomiting on the weekend (onset of symptoms reported as 04 May 2013). The infant was hospitalized on Sunday, 05 May 2013 and diagnosed with intussusception. No laboratory, diagnostic tests, or treatments were reported. The patient was discharged on Monday, 06 May 2013. She was seen in the office on Wednesday, 08 May 2013, and is "OK now". The patient's outcome was reported as recovered on 08 May 2013. Documents held by sender: None.
big red spot on arm; hot; like inflammation; itchy; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (big red spot on arm), FEELING HOT (hot), INFLAMMATION (like inflammation) and PRURITUS (itchy) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     Concurrent medical conditions included Chronic granulomatous disease. Concomitant products included LISINOPRIL, CHOLECALCIFEROL and ZINC for an unknown indication.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Jan-2021, the patient experienced RASH MACULAR (big red spot on arm), FEELING HOT (hot), INFLAMMATION (like inflammation) and PRURITUS (itchy). The patient was treated with FLUOCINONIDE (TOPSYN) at a dose of unknown. At the time of the report, RASH MACULAR (big red spot on arm), FEELING HOT (hot), INFLAMMATION (like inflammation) and PRURITUS (itchy) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Narrative: Patient died on 4/8/2022 at home in hospice care. COMMUNITY AGENCY: Pt had received a covid vaccine on 7/20/21 (J&J). Likely vaccine not related to pt's death given advanced age (80yo) & multiple comorbidities & in hospice care. See pt's problem list below: Problem List: Full care by hospice Seen by palliative care medicine service BP - High blood pressure History of deep vein thrombosis Vitamin B6 deficiency Essential tremor Seen by palliative care service Closed fracture of greater trochanter of left femur Debility Dementia of the Alzheimer type with behavioral disturbance OA - Osteoarthritis Vitamin D Deficiency Serum vitamin B12 low Seen by palliative care medicine service Dementia Mild Cognitive Impairment, so stated Depressive disorder Lipoma Chronic post-traumatic stress disorder (Hypercholesterolemia Abnormal Urinalysis Alcohol dependence Tobacco user Finding of increased blood pressure H/O: gout Anemia Prostate cancer Localized swelling, mass and lump, lower limb Preventive Counseling, Unspec
This spontaneous report as received from a licensed practical nurse (L.P.N.) refers to an unspecified number of patients of unknown age and gender. Medical history, drug reactions or allergies and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot# L007560 with expiration date 15-JUN-2017 and lot# L011846 with expiration date 16-JUN-2017, dose and route of administration were not provided). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
left chest muscles move; arm hurts a lot at the injection site; feels his arms and legs like they are numb, they feel; they feel weak; tired; heart was beating fast; dizziness; short of breath; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (short of breath), PALPITATIONS ( heart was beating fast), DIZZINESS ( dizziness), CHEST DISCOMFORT (left chest muscles move) and INJECTION SITE PAIN (arm hurts a lot at the injection site) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, the patient experienced DYSPNOEA (short of breath) and DIZZINESS (dizziness). On an unknown date, the patient experienced PALPITATIONS (heart was beating fast), CHEST DISCOMFORT ( left chest muscles move), INJECTION SITE PAIN (arm hurts a lot at the injection site), HYPOAESTHESIA (feels his arms and legs like they are numb, they feel), ASTHENIA (they feel weak) and FATIGUE (tired). At the time of the report, DYSPNOEA ( short of breath), PALPITATIONS (heart was beating fast), DIZZINESS (dizziness), CHEST DISCOMFORT (left chest muscles move), INJECTION SITE PAIN (arm hurts a lot at the injection site), HYPOAESTHESIA (feels his arms and legs like they are numb, they feel), ASTHENIA (they feel weak) and FATIGUE (tired) outcome was unknown. Not Provided      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.   No concomitant medication was reported . No treatment medication was reported . Upon internal review on 4-Aug-21, the age was corrected to 51 years.
So, it was a skin reaction where at first my skin just got red on my face, neck, ears, chest itchy swollen, it was very itchy. The skin around my right eye was red and swollen and impairing my vision. The rash started with a slow progression over a few days and got really bad. There were concerns that I would go into anaphylactic shock due to how swollen my neck was and there were concerns with my vision which was intense as well.  I went to the urgent care on the 17th or 18th (of April), they gave me a asteroid shot, and then it helped, but it did not really solve the issue. A few days later I went to a different urgent care they gave me another steroid shot, which did not help a lot.
Mother reports that child developed redness and firmness at the left arm inject site on 4/10/03 p.m. On 4/11/03 child's left arm was inflamed & significantly swollen from shoulder to elbow. Pediatrician examined child on 4/11/03, advised using Benadryl and Motrin. SXs resolved by 4/13/03.
A report has been received from a Pharmacist concerning an 8 year old, female subject, who had been receiving FLUMIST QUADRIVALENT (intranasal), half dose. FLUMIST QUADRIVALENT (intranasal) started on an unknown date. It was reported that the patient administered FLUMIST QUADRIVALENT yesterday and when administering the 2nd nostril the FLUMIST QUADRIVALENT locked up/jammed. No symptoms noted on administration. The outcome of the event of 2nd nostril-FLUMIST QUADRIVALENT locked up/jammed is unknown. The report was considered to be non-serious.
Fever; This case was reported by a pharmacist via call center representative and described the occurrence of fever in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fever. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the fever was unknown.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was captured as an adult as per vaccine indication. No patient demographics were provided. The pharmacist stated that the patient complained of fever after receiving the dose of the Shingrix vaccine. It was reported that in spite of having a fever, the patient came back and got the 2nd dose.  The pharmacist recommended Tylenol immediately before receiving the 2nd dose. This case has been linked with the case US2019AMR113675, reported by same reporter.
AM's after the SARS-CoV-2 vaccination noticed feeling of discomfort at Right Lower back on the skin & husband saw rash - red & rough skin & later developed vesicles - fluid filled at (R) low back - lots of pain & pain involved sciatic nerve - electric shock pains down (R) leg x 8 weeks
since the 2nd vaccine I've had pain in both hands; since the 2nd vaccine I've had pain in my fingers, in the joints; since the 2nd vaccine I've had pain in my fingers, in the joints; tendons and connective tissue like pain; general pain in my feet; This is a spontaneous report from contactable consumer (patient) reported for herself. A 75-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EN6208, Expiration Date: 30Jun2021) intramuscular, administered at an unspecified anatomical location on 12Mar2021 (age at vaccination was 75 years) as 2nd dose, single for COVID-19 immunization. The patient's medical history included back pain. Concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EN6200, Expiration Date: 30Jun2021) intramuscular, administered at an unspecified anatomical location on 19Feb2021 (age at vaccination was unknown) as 1st dose, single for COVID-19 immunization. The caller reported that she always had back pain, but since the 2nd vaccine she had pain in both hands, fingers in the joints. But the finger pain wasn't like arthritis pain it felt more tendons and connective tissue like pain. She has also had general pain in her feet and have had no pain management. Side effects were ongoing. The caller stated she was going to a pain management physician for the pain today. The caller stated that she took ibuprofen and Aspirin to help relieve side effects. Verified with caller that vaccine received was Pfizer. The caller inquired whether the side effects experienced be a result of the Vaccine. The caller inquired how long the side effects would last and seeked medical recommendations. The caller was informed that they were unable to provide any medical recommendation and advised patient to follow up with HCP for additional medical recommendations or concerns and to follow up with Pfizer to report side effect and for further medial inquires. The outcome of the events was not resolved.