chrisvoncsefalvay/vaers-outcomes huggingface dataset:
1-20-2021 at 9:00pm i started getting cold, woke up the next day entire body and head aching. as day progressed it got worse, i could barely move and i had a temperature of 100.9. felt as bad in one day as i did with covid. by 6:00 am the next day i was find except for pain where i got the shot.
Patient is an 83 year old male with a history of HTN, Type II Diabetes Mellitus, hypercholesterolemia, asthma, and a right common carotid artery stent placement who presents to the ED with a chief complaint of shortness of breath that began yesterday. Patient reports that since yesterday he has been experiencing shortness of breath accompanied by wheezing, coughing, and fatigue. He further reports that he has a history of asthma which he controls with Flonase, but he denies any at home use of oxygen or ever following up with a pulmonologist. However, out of concern for his aforementioned respiratory symptoms, the patient decided to present to the ED today for an evaluation. Patient otherwise denies any tobacco use and has no further concerns or complaints at this time.
Patient received the first dose with the Moderna Covid-19 vaccine and the second dose with the Pfizer vaccine; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient received the first dose with the Moderna Covid-19 vaccine and the second dose with the Pfizer vaccine) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    No Medical History information was reported.   On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-May-2021, the patient started TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On 07-May-2021, the patient experienced WRONG PRODUCT ADMINISTERED (Patient received the first dose with the Moderna Covid-19 vaccine and the second dose with the Pfizer vaccine). On 07-May-2021, WRONG PRODUCT ADMINISTERED (Patient received the first dose with the Moderna Covid-19 vaccine and the second dose with the Pfizer vaccine) had resolved.        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.   This case was linked to US-MODERNATX, INC.-MOD-2021-114483 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-114483:Case for patient 1
This spontaneous reprot was received from a health care professional refers to six unspecified patients of unknown demographics. On an unknown date the patient was vaccinated with PNEUMOVAX23 (dose, route, frequency, lot # unspecified). Concomitant therapy was not reported. On an unknown date the patients were administered improperly stored PNEUMOVAX23. No adverse event reported. The outcome of incorrect product storage and no adverse event was unknown. No product quality complaint involved. Additional information has been requested.
Information has been received from a physician concerning a 21 year old female with hypothyroidism and hypercholesterolaemia and a history of hives in the past who on 27-AUG-2008 was vaccinated intramuscularly with the first 0.5 ml dose of GARDASIL vaccine (yeast) (lot no. 659655/1486U). Concomitant therapy included (SYNTHROID), (MSD) and hormonal contraceptives (unspecified). On 30-AUG-2008 the patient developed hives on both upper and lower extremities, stuffy nose, sore throat and "a full feeling" in her ears. The physician stated that the patient was "cleaning out a friend's apartment on 29-AUG-2008 and was exposed to a lot of dust and mold at that time". The patient was examined in the office on 03-SEP-2008 and was prescribed topical steroid cream. At time of this report, the patient's symptoms persisted. Additional information has been requested.
Itching; Pain; Shingles; This is a spontaneous report from a contactable consumer, the patient. A 68-years-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: en6205) via an unspecified route of administration in the arm left on 19Mar2021 at 09:00 (at the age of 68-years-old) as a single dose for COVID-19 immunisation. Medical history included shingles in Nov2020 and obesity. Concomitant medications included ibuprofen (MANUFACTURER UNKNOWN) from unknown date for unknown indication. Patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 24Mar2021 after receiving vaccine, the patient had shingles pain and itching. The patient did not received any treatment for reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events shingles, itching and pain was not recovered.  No follow-up attempts are needed. No further information is expected.
Information has been received from a pharmacist via company representative, concerning an unspecified number of elderly patients (reported as "fewer than five patients" but "probably two patients", of 65 years old or older) of an unknown gender. The patients' medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medication were not reported. On an unspecified date in September 2017, the patients were vaccinated with one shot of PNEUMOVAX 23 injection (strength, dose number, anatomical location, lot number and expiration date were not provided) for prophylaxis. On an unknown date in 2017, the patients experienced redness and swelling at the injection site after receiving PNEUMOVAX 23. It was unknown if patients sought medical attention or if laboratory diagnostics or studies were performed.  About one week later, on an unspecified date in 2017, the patients recovered from the adverse events. The causal relationship between the aforementioned adverse events and the PNEUMOVAX 23 was not assessed.
This spontaneous report was received from an unspecified reporter, and refers to a child patient of unknown age and gender. No information about the patient's medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not provided. On an unknown dates, the patient was vaccinated with two doses of GARDASIL 9 injection, for prophylaxis, (strength, dose, frequency, lot number and expiration date was not provided). Furthermore, it was reported that the patient was injected with GARDASIL 9, the product injected  was limpid transparency liquid, but was a little bit turbid translucent liquid. Moreover, it was also reported that after thorough agitation, GARDASIL 9 should appear as a white, cloudy solution. Product quality complaint (PQC) was involved.
I95.9 HYPOTENSION 12/22/2022 ENTEROCOCCUS INFECTION I95.9 HYPOTENSION 12/22/2022 CHOLANGITIS I95.9 HYPOTENSION 12/22/2022 PANCREATIC CANCER, UNSPECIFIED SITE
2 patients less than 65 years of age who was given fluzone high dose quadrivalent instead of fluzone quadrivalent with no reported adverse event; 2 patients less than 65 years of age who was given fluzone high dose quadrivalent instead of fluzone quadrivalent with no reported adverse event; Initial information received on 06-Oct-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to case 2023SA309081.  This case involves a 64 years old male patient where reporter reported 2 patients less than 65 years of age who was given influenza quadrival a-b high dose hv vaccine [Fluzone high-dose quadrivalent] instead of influenza quadrival a-b vaccine [Fluzone quadrivalent] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect influenza quadrival a-b high dose hv vaccine (lot- U8135BA and expiration date- 30-Jun-2023) via unknown route in unknown administration site (dose, formulation, strength: not provided) for Immunisation and received a dose of suspect influenza quadrival a-b vaccine Suspension for injection lot number not reported via unknown route in unknown administration site (dose, strength: not provided) for Immunisation (wrong product administered) and (product administered to patient of inappropriate age) (latency- same day).  Action taken- not applicable.  At time of reporting, the outcome was Unknown for the event.  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.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No concurrent conditions or medical history were provided. On an unspecified date in 2016 (reported as "on or after 03-MAR-2016"), the patient was vaccinated with an improperly stored dose of ROTATEQ oral liquid (lot # M002252 with expiry date: 28-FEB-2017, orally; exact dose was unspecified). There were no concomitant medications provided. The administered vaccine underwent the temperature excursion at 8.3 degrees Celsius for 19 minutes. There was no previous temperature excursion. Data logger was involved. No concomitant medications were reported. No adverse effect was reported. This is one of several reports from the same source. Additional information has been requested.
Sore arm; Body pain; Migraine; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on an unknown date (at the age of 37-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medication. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on an unknown date as a single dose for COVID-19 immunisation. On an unknown date, 1st day, the patient experienced sore arm and Couldn't touch or lay on it. 2nd day, the patient experienced body pain and was still Couldn't touch or lay on that same arm. 3-4 day, the patient experienced migraine set in for 2 days, less arm and body pain. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event migraine set in for 2 days was resolved on an unknown date and of the events sore arm, Couldn't touch or lay on it and body pain was resolving at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
This spontaneous report as received from a registered nurse via a company representative refers to 2 patients of unknown age. There was no information about the patient's concomitant medications, allergies and pertinent medical history reported. On unknown dates, the patients were vaccinated with PNEUMOVAX 23 one dose, (lot#, expiry date, route and site of administration were not reported). On unknown dates, the patients experienced injection site pain. Unspecified treatment was given for the event. On an unknown date, the patient recovered from the injection site pain. The patient seek medical attention via contacting the nurse. The relatedness between the event and PNEUMOVAX 23 was not reported. Additional information is not expected as the reporter did not give a consent for further contact.
A report has been received from a Health Professional concerning a 50 year old, female subject, who had been receiving Nasal FLUMIST QUADRIVALENT. The patient's concurrent disease(s) included Type II diabetes. Concomitant medications included amoxicillin, ciprofloxacin, clindamycin, nitrofurantoin, sulfamethoxazole, trimethoprim and phenazopyridine hydrochloride. FLUMIST QUADRIVALENT started on 13-Jan-2014. The patient was 50.5 years old when she received FLUMIST QUADRIVALENT which started on 13-Jan-2014. The outcome of the event of administration to 50.5 year old is unknown. The report was considered to be non-serious by the reporter.
pt was seen in ED yesterday with Left lower lobe pneumonia and UTI; presented back to ED today after being so weak she fell and EMS was called; pt is confused and has tachycardia; c/o SOB and cough today, appetite decreased; dx with A Fib with RVR; positive for COVID; respiratory failure requiring aggressive O2 therapy; acute metabolic encephalopathy; comfort care measures instituted; pt died in the hospital
Welts; Shingles; sore arm; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (sore arm), URTICARIA (Welts) and HERPES ZOSTER (Shingles) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 31-Jan-2021, the patient experienced URTICARIA (Welts) and HERPES ZOSTER (Shingles). On 26-Jan-2021, PAIN IN EXTREMITY (sore arm) had resolved. At the time of the report, URTICARIA (Welts) and HERPES ZOSTER (Shingles) outcome was unknown.        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.   Concomitant medication use was not provided. Treatment information included Valtrex and other vitamins.
This spontaneous report was received from a licensed practical nurse, and refers to an unspecified numbers of patients of unknown age and gender. On unspecified dates since 01-MAR-2015, the unspecified number of patients received an improperly stored dose of RECOMBIVAX HB, lot # K007263, expiration date on 09-JUN-2016 (strength, dose #, dose, route of administration and anatomical location were not provided). There was not concomitant medication reported. No adverse effects were reported. There was not a product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
- fever started Friday. Reaching maximum 103.9 Saturday night. Gradually improved Sunday but low level fever (99F) still present Monday and Tuesday (10/12 and 10/13) - Started 150 mg Ibuprofen Saturday (10/10/2009) every 8 hours. Continued till Sunday night. - Called our physician who said that it was a reaction to flu nasal spray vaccine. She did not ask for tests or other visits.
I experienced after 24 hours, I felt chills, fever, fatigued, horrible headaches, left sore arm and then my symptoms went away. On 04-22-2021, I experienced nasal congestion, pain in my nose, cheeks, ears, pain to the back of my head, lost my tense of smell and taste and had real bad cough. The doctors treated me as Covid, I did got tested twice for Covid but my results came back negative. The doctors treated me as a Covid symptoms.  I also got tested for flu through my nose. I went to a military station to get my first covid test and my second was at an urgent care.   After two weeks my symptoms of flu-like symptoms, headaches and fatigued went away.  On 4-22-2021 I can say that the same symptoms that I experienced, my daughter and husband also get the same symptoms and it was significant amount of nasal drainage, cough and flu-like symptoms.
9/13/2021 - 9/20/2021 (7 days)     Last attending ? Treatment team Acute cystitis without hematuria  Principal problem     * (Principal) Acute cystitis without hematuria Yes       Non-ST elevation MI (NSTEMI)  Yes       Acute on chronic kidney failure Yes       COVID-19 virus infection Yes       Generalized weakness Yes       Coronary artery disease Yes       Anemia Yes       Status post fall Not Applicable            Medical Problems        Plan: 84-year-old gentleman presents with multiple's complaints and he has non-ST elevation MI, acute on chronic kidney failure COVID-19 infection with hypoxemia and generalized weakness.  At this point he is going to be admitted, I will give him IV heparin aspirin beta blockers and nitrates.  We will cycle his troponins and he will be seen by cardiology.  Cardiologist was informed from emergency room and since there are no beds available in the surrounding hospitals he will be kept here.  I will hold off on his statin and check patient's CPK.  If CPK is acceptable we will continue statin.  At the same time urine will be cultured and patient be on Rocephin.  For the Covid patient will be supplied with oxygen, will put home on dexamethasone.  Until kidney function improves remdesivir is not indicated.  Will give cautious IV hydration especially with underlying MI.  I reviewed his records in February his EF was normal.  Will continue IV fluid and monitor kidney function. I discussed patient's CODE STATUS with him given with all this medical active issues.  He wants to be full code.  Eventually PT OT for placement. Note, patient's knee x-rays are not read by radiologist.  Grossly there not showing any fracture.  If there is any issues orthopedic services should be involved.   VTE prophylaxis: IV heparin Full Code
On 3/10/2000, noticed twice as much hair as usual came out after shampooing. Each day since, hair is coming out in clumps.
12 hours after second shot (1/29/2021):  Chills for 5 hours, 101 fever; 24 hours after second shot (1/30/21):  99 fever and throbbing pain in left and right forearms.  Took 1 Tylenol on 1/30/21 that relieved the fever but not the pain in the forearms.  Pain in forearms stopped on 1/31/2021.
Down syndrome; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A fetus patient was exposed to bnt162b2 (BNT162B2), transplacental (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The mother's relevant medical history and concomitant medications were not reported. The following information was reported: TRISOMY 21 (non-serious), outcome "unknown", described as "Down syndrome".  Additional information The mother's vaccination history included: Bnt162b2 (Dose 1), for Covid-19 Immunization. Customer Verbatim: My was was vaccinated while we were trying to conceive our child. She received her second dose 1 week before conception and now we are expecting a baby with Down syndrome. Both of us are in our 20Ts and this is a very unlikely circumstance. I need someone to call me and try to explain that the vaccine is not the reason for this genetic disorder.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200058948 same reporter/drug, different patient/event (fetus)
pt devel severe erythema & swelling @ the inject site w/in 48 hrs of receiving Tetanus toxoid Adsorbed; pt was treated w/Cephalexin for this adverse event;
Received COVID-19 booster on afternoon 2 November 2021.  Next day had similar symptoms from Moderna second shot:  sore arm, headache, chills and fatigue.  In addition, in the late afternoon started had a fast-beating /pounding heart.  The fast heart beating subsided toward evening and I did not seek medical care.
Hep B shot given at 1 PM. 7 PM developed fever - 101.9 (R), "not herself" quiet - hard spot where shot given. Fever x 48 hours.
Fever, chills, malaise, arthralgia, sore arm, ancillary adenopathy and  headache started afternoon on March 16, 2021 approx 21 post vaccination. Headache quickly turned into migraine.  Over the next  eight days had migraine almost continually with intermittent relief with  abortive medication.  Consulted with neurology and was prescribed 60 mg prednisone taper with increase of Imitrex up to 200 mg a day.  Prednisone broke the migraine cycle after three doses.  Taper completed as prescribed.  At follow up neurology appt advised that if booster doses materialize, I should carefully way risk & benefit before taking same.  My migraines have been well controlled for years prior to taking the second  vaccine.
5/2/06-Arm started hurting, red, raised limb at site of injection. 5/3/06-Body hurting everywhere, > neck, jaw, back, knees, hips and across chest. 5/4/06-Body pain disappeared. Only pain in arm. 5/5/06-Pain in arm continues.
The night of the vaccinations patient ran an unusually high fever of 102.3. I gave her ibuprofen for the fever every 6 hours and the fever would not break but for only a little while and then she would run the fever again. The next morning when she woke up, she was weak and her left arm was extremely swollen and hard, and all red, and she couldn't move it. I took her immediately to the Urgent Care and by the time we got there patient had a blistery rash all over her. Patient also had a viral looking rash too. I was told by the Urgent Care Doctor that she was having a severe allergic reaction to one of the vaccinations and too watch her carefully for any other signs and to give her Benedryl and alternate Tylenol and Ibuprofen every 4 hours, and to get her in to her Pediatrician on Monday. I took her into Doctor on Monday the 20th of October, and patient was still running a fever, now for 3 1/2 days. She was examined and I was told to continue doing wat I was doing. By Wednesday October 22, patient was still running a fever and now was breaking out in hives all over in patches. So I took patient back in to see Dr., and was told to give her Zyrtec every day and we were referred to an allergy specialist. Patient's fever finally broke after 6 days straight. But the hives are continuing at this time and I am still having to give her Zyrtec every day.