chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Hospitalized (10.28.21);  COVID-19 vaccine (10.27.21);  fully vaccinated Admission Date: 10/28/2021 Discharge Date: 11/1/2021 PRESENTING PROBLEM: Pneumonia due to COVID-19 virus HOSPITAL COURSE: 74 y.o. female with known permanent atrial fibrillation on warfarin, chronic left bundle branch block, non-insulin-dependent diabetes mellitus type 2, obesity and essential hypertension who presented with a chief complaint of worsening COVID-19 symptoms. Symptoms started 2 days prior to admission with fevers and cough with associated fatigue and generalized weakness. Patient lives independently and had a fall the night before admission and unable to get up on her own. EMS was then called and patient was brought in to the hospital and was diagnosed with COVID-19 pneumonia at the time. Upon emergency department arrival patient was noted to be mildly tachypneic, hypoxic at 87% and requiring at least 2 L nasal cannula oxygen support to maintain saturations above 92%. Workups at emergency department, complete blood count unremarkable INR therapeutic, chest x-ray showed patchy nonspecific airspace opacities that can be seen with COVID-19 infection.  Patient was then admitted to hospitalist service for further management. On admission, elemental oxygen support continued a 2 L nasal cannula.  Patient was started on remdesivir IV with planned completion of 5 doses.  She was started on Decadron as well.  CRP were monitored and continued to have shown down trending throughout hospital stay.  Patient subsequently weaned off oxygen on her 3rd hospital stay.  With patient's diabetes and her oral hypoglycemic medications were held, she was placed on insulin corrective.  With patient's respiratory status stability and CRP improved, Decadron had been discontinued.  Patient continued to do well maintaining saturations at room air,  without any fever episodes and liver function stable although elevated.  Patient was discharged to home stable after last dose of remdesivir infusion.
she is worried that the vaccine they gave her was not stored in the right temperature since they only had the vaccines in a Styrofoam cooler; antibodies while she tested negative; sore arm; felt tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 04May2021 20:46 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "cystic fibrosis" (unspecified if ongoing), notes: cystic fibrosis; "serious lung disease" (unspecified if ongoing), notes: serious lung disease; "diabetes" (unspecified if ongoing), notes: diabetes. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose. 04May2021 20:46:32), administration date: 04May2021, for COVID-19 immunization. The following information was reported: CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (non-serious), outcome "unknown", described as "she is worried that the vaccine they gave her was not stored in the right temperature since they only had the vaccines in a Styrofoam cooler"; ANTIBODY TEST NEGATIVE (non-serious), outcome "unknown", described as "antibodies while she tested negative"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm"; FATIGUE (non-serious), outcome "unknown", described as "felt tired". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: It was reported that, after 30 days, her husband tested positive for antibodies while she tested negative. She wanted to know the reason behind this. She said she was worried since she saw on the news that Covid is "so bad" in India. She also said that she was worried that the vaccine they gave her was not stored in the right temperature since they only had the vaccines in a Styrofoam cooler. The Consumer wanted to know how Pfizer tested the efficacy of the Pfizer-BioNTech Covid-19 Vaccine. She also wanted to know what type of antibody test she should take to assess the vaccine's efficacy. The reporter was also told the consumer that the efficacy of the vaccine was by the number of the of positive Covid cases after vaccination. Then, I referred her to her HCP for more information and for further guidance. The Consumer said they received the 2nd dose of the Pfizer-BioNTech Covid-19 Vaccine 4 weeks after the 1st dose. The Consumer said on the first day after receiving the Pfizer-BioNTech Covid-19 Vaccine she had a sore arm, and felt tired. She said, other than that, she did not have any other reaction. With that, she wanted to know if the vaccine was still effective if she did not have other reactions. Reporter enquired if the vaccine working if patient didn't have an adverse event.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021499000 same reporter/drug with different patient, similar event
infection in the lower eye lid; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patients medical history and concomitant medications were not reported. Patient was taking eye drops, tobramycin, dexamethasone, ophthalmic suspension for a underlying medical condition. On an unspecified date, it was reported that patient was in the middle of a ten day prescription of Tobramycin, Dexamethasone (lot number: 342311, expiry: Feb2022) ophthalmic suspension to treat an infection in the lower eye lid. One of the drugs in the suspension was an antibiotic. Patient further wanted to know that theses drugs would have any effect on the efficacy of the second COVID19 vaccination and patient was scheduled to receive the second dose towards end of the week. Patient also heard on the news its not recommended to take the NSAIDS or Aleve before getting vaccine.  Information about the Lot/batch number has been requested.  Follow-up attempts completed. No further information expected.
This spontaneous report was received from a nurse and refers to 4 patients of unknown age and gender.  The patients' medical history, concurrent conditions, and allergies were not reported. Concomitant therapies included sterile diluent (manufacturer unknown). On 16-MAY-2017, one patient was vaccinated with an improperly stored dose of VARIVAX and on 19-MAY-2017, three patients were vaccinated with improperly stored doses of VARIVAX, all for prophylaxis (doses and routes of administration were not reported). It was unknown by the nurse which specific vaccine lot numbers were administered on each specific date of administration. Lot # M048200 with expiration date 07-DEC-2018 (which was reconstituted with sterile diluent (manufacturer unknown) L025375 with expiration date 14-MAR-2018) and Lot # M045204 with expiration date 11-NOV-2018 (which was reconstituted with sterile diluent (manufacturer unknown) N007760 with expiration date 31-MAY-2018). The sterile diluent (manufacturer unknown) used to reconstitute the vaccine was properly stored. No symptoms were reported. The doses of the vaccine were exposed to a temperature of 8.8 degree Celsius Fahrenheit (°F) for a time frame of 30 minutes. There were no previous temperature excursions. A digital data logger was involved. Furthermore, No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1705USA015777:
COVID ARM; Itchiness; Red Area; Swelling; Fever of 102 degrees; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (COVID ARM), VACCINATION SITE PRURITUS (Itchiness), VACCINATION SITE ERYTHEMA (Red Area), VACCINATION SITE SWELLING (Swelling) and PYREXIA (Fever of 102 degrees) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Mar-2021, the patient experienced VACCINATION SITE REACTION (COVID ARM), VACCINATION SITE PRURITUS (Itchiness), VACCINATION SITE ERYTHEMA (Red Area), VACCINATION SITE SWELLING (Swelling) and PYREXIA (Fever of 102 degrees). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and NAPROXEN at an unspecified dose and frequency. On 14-Mar-2021, PYREXIA (Fever of 102 degrees) had resolved. At the time of the report, VACCINATION SITE REACTION (COVID ARM), VACCINATION SITE PRURITUS (Itchiness), VACCINATION SITE ERYTHEMA (Red Area) and VACCINATION SITE SWELLING (Swelling) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Mar-2021, Body temperature: 102 °F (High) 102.         No concomitant medications were reported.
PASSED OUT (FAINTED); HEART RATE OF 43; HEART RATE AS HIGH AS 149; TIREDNESS; HOT FLASHES; CHILLS; This spontaneous report received from a patient concerned a 59 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included seasonal allergies, and penicillin allergy. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 205A21A expiry: UNKNOWN) dose was not reported, 1 total dose administered on 11-APR-2021 on left deltoid for prophylactic vaccination. No concomitant medications were reported.  On 11-APR-2021, the patient experienced hot flashes and chills which would come and come. She did not had temperature, but she took paracetamol (Tylenol) for her side effects. On 12-APR-2021 (within 24 hours of getting the vaccine), she passed out (fainted), which occurred once. While passed out her heart rate was 43 which she said lasted for minutes. Her heart rate was as high as 149 since she has received the vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from passed out (fainted), had not recovered from hot flashes, chills, and tiredness, and the outcome of heart rate of 43 and heart rate as high as 149 was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0. 20210424060-covid-19 vaccine ad26.cov2.s -Passed out (fainted). This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
This spontaneous report was received from a physician refers to a 48 year old male patient. The patient was vaccinated with a dose of 0.5 ml PNEUMOVAX 23. On an unknown date, the patient experienced high fever of 104 degrees, aches and pain, dizziness and excruciating pain in the armpit area after receiving the vaccination. There were no treatment information reported. The outcome of the events were unknown at the time of this report. This is one of the several reports received by the same reporter. Additional information has been requested.
Pfizer / BioNTech vaccine administration date=04May2021/ COVID 19 Treatment start date=13May2022; Pfizer / BioNTech vaccine administration date=04May2021/ COVID 19 Treatment start date=13May2022; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 27-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Mar2021 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "POTS" (unspecified if ongoing); "chronic migraine" (unspecified if ongoing); "GRED" (unspecified if ongoing); "PASC" (unspecified if ongoing), notes: long covid/PASC. Concomitant medication(s) included: METOPROLOL TARTRATE, start date: 01Dec2020.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "Pfizer / BioNTech vaccine administration date=04May2021/ COVID 19 Treatment start date=13May2022".Therapeutic measures were taken as a result of covid-19. The patient received Paxlovid as other medication in 2weeks for COVID-19 treatment. Treatment start date was reported as 13May2022 and stop date was 15May2022. The list of other medication patient received in 2 weeks was Metoprolol start date: 01Dec2020; Methyl prednisone pack start date: 11May2022; Azithromycin (zpack) start date: 11May2022.Device timestamp: 15May2022  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information currently available,The casual association between the reported events and suspected vaccine BNT162B2 cannot be completely excluded.
Patient repeatedly began waking up frightened and crying (sometimes inconsolably). The condition continued throughout the night the patient woke up every hour frightened and complaining of a "bo bo."  The following morning the areas around her eyes became very puffy and there was some green discharge (her eyes however were not red or pink) the patient continued to be very irritable. (By midday the patient relentlessly started scratching her bottom complaining of a "bo bo." A rash soon developed). Later that night patient awoke at 8PM crying uncontrollably this time her eyes would barely open because they were so swollen. There was only only minimal if any discharge from they eye it was simply very red and very swollen to the point she was unrecognizable, it looked like one having a severe allergic reaction. The Dr prescribed antibiotic eye drops claiming it was an eye infection (which we administered then). By morning it was not so much better and we gave her Benadryl which helped reduced the swelling and improved her mood overall. (of note the patient had fever the night after the vaccination but that went away the following morning and she has lost her appetite since)
This spontaneous report as received from a healthcare worker refers to a patient of unknown age. On 19-FEB-2013 the patient was vaccinated with improperly stored VARIVAX (Merck) (lot # H018015; expired date: 14-OCT-2013) (dose and route unspecified). The vaccine was stored in refrigeration under 46 degrees Fahrenheit from 07-FEB-2013 to 27-FEB-2013. The outcome of the event was unknown. No adverse effect reported. This is one of three reports from the same reporter. The MARR# of the other two reports are 1303USA000093 and 1303USA000094. Additional information has been requested.
swollen lymph nodes; arm pain; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from a Pfizer sales representative.  A patient (no qualifiers provided) received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LYMPHADENOPATHY (non-serious), outcome "unknown", described as "swollen lymph nodes"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm pain".  No follow-up attempts are possible. No further information is expected.
nausea, VERY SEVERE Muscle -nerve pain in feet, legs, hips, hands along with numbness, and severe weakness and balance problems--pain unbearable.  Am now getting Oxygam infusions.  Also have had continual sores in mouth and on lips.   I am not over this yet, but pain has gotten some better.
Developed pain in his left shoulder / later the right as well; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Developed pain in his left shoulder / later the right as well) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     The patient's past medical history included Joint replacement.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced ARTHRALGIA (Developed pain in his left shoulder / later the right as well). At the time of the report, ARTHRALGIA (Developed pain in his left shoulder / later the right as well) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
During registration process, the patient did not have access to their vaccine reccords. When asked how many doses he received, he stated he did not remember. I looked up his records through the website and it stated that he only received one primary dose of Moderna. I repeated this information to the patient and informed him that since he didn't remember how many dose he received, we will be going off what was provided from the website and that he would be getting the second primary dose. He said okay. When he was with the Vaccinator, she repeated that he was getting a Moderna Primary dose today, he said okay. She repeated herself again, stating it was a Primary dose, and he answered okay again. After..
12:06 AM 60y.o. female presents to the ED with PMHx of DM, A-Fib, and HTN on 11/16/2021 complaining of generalized body aches and cough. Patient states that she was diagnosed with pneumonia mid October 2021. She was prescribed antibiotics with symptomatic relief. She states that her current symptoms are similar to the symptoms she experienced when she had pneumonia. Patient says that she has been sick since 11.12.2021 and has been experiencing cough with sputum, wheezing, fevers and chills. She also feels SOB when walking and lightheaded. Patient is able to sleep flat at night. No one is sick around the patient. Patient uses albuterol with symptomatic relief. She denies nausea, vomiting, diarrhea, constipation, abdominal pain, or chest pain.  Patient received both doses of Moderna Covid vaccine. Patient is a non smoker. Pt is on Eliquis.    Covid-19 Vaccine (Moderna)            04/03/2021  05/01/2021   Review of Systems  Constitutional: Positive for fatigue. Negative for activity change, chills and fever.  HENT: Negative for congestion, ear discharge, sinus pressure, sore throat and trouble swallowing.   Eyes: Negative for pain and discharge.  Respiratory: Positive for choking, shortness of breath and wheezing. Negative for cough.   Cardiovascular: Negative for chest pain, palpitations and leg swelling.  Gastrointestinal: Negative for abdominal distention, abdominal pain, nausea and vomiting.  Genitourinary: Negative for difficulty urinating, dysuria and frequency.  Musculoskeletal: Positive for myalgias. Negative for back pain, neck pain and neck stiffness.  Skin: Negative for color change and rash.  Neurological: Negative for dizziness, syncope, light-headedness and headaches.  Psychiatric/Behavioral: Negative for agitation and confusion.
diverticulitis; Vaccination sites (both) still bleed and have not fully healed; Swelling; to the point of not being able to eat for days.; This is a spontaneous report from a contactable consumer reported for himself  A 49-years-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 01May2021 13:15 (Batch/Lot Number: ew0170) as DOSE 1, single and dose 2 via an unspecified route of administration, administered in Arm Left on 22May2021 13:15 (Batch/Lot Number: ew0182) as DOSE 2, SINGLE for covid-19 immunisation. Facility type vaccine: Pharmacy or Drug Store. Dose 1 of bnt162b2 was administered on 01May2021 for covid-19 immunisation. Medical history included abdominal hernia, hypertension, immune-mediated adverse reaction, mycotic allergy, implantation complication. Concomitant medication included carvedilol (COREG CR). The patient previously took sulfur and experienced drug hypersensitivity, erythromycin and experienced drug hypersensitivity. The patient experienced diverticulitis (medically significant) on 02May2021 14:00 with outcome not recovered, vaccination sites (both) still bleed and have not fully healed (non-serious) on 02May2021 14:00 with outcome not recovered, swelling (non-serious) on 02May2021 14:00 with outcome not recovered, to the point of not being able to eat for days (decreased appetite) (non-serious) on 02May2021 14:00 with outcome not recovered.
Hand itching and red given Benadryl Liquid 25mg PO at 3PM and capsule to take every 6 hours if needed student to Follow up if any worsening of symptoms but never returned
Injection site reaction: "soreness, feels hot" (2 days after immunization given).
Nausea, vomiting, cold sweats, chills, fever, extreme fatigue, headache
100PM WITH BLOOD DRAW BECAME DIZZY THEN WENT TO WORK AS A COOK IN HOT SETTING THAT EVENING AROUND 9PM FELT DIZZY, PALE, AND PASSED OUT. HE COMPLAINED OF BLURRED VISION, PALLOR, PAIN AT INJECTION SITE AND NAUSEA FOR 3 DAYS THEN FULLY RECOVERED. HE WENT TO ED ON 7/22/2010 AND THOUGHT HE POSSIBLY HAD A VIRAL ILLNESS.
Brief febrile seizures 24 hrs after vaccination. Temp 102.5. Will offer antipyretics TYLENOL +/- MOTRIN for fever management.
The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 14-DEC-2017, the patient was vaccinated with an improperly stored dose of PROQUAD (recombinant Human albumin) (strength and route were unknown) (lot#  M044718 and expiration date 07-MAY-2018) for prophylaxis (Incorrect product storage). The sterile diluent (MERCK) was properly stored. No adverse event was reported. The excursion temperature on 22-SEP-2017, 17-OCT-2017, 06-DEC-2017, 07-DEC-2017, 30-JAN-2018, 23-FEB-2018, 18-MAY-2018, 05-JUL-2018, 15-AUG-2018 was 6 degree Celsius for maximize 8.75 hours. The excursion temperature on 02-MAR-2018, 27-AUG-2018 was 7 degree Celsius for maximize 8.75 hours. The excursion temperature on 07-DEC-2017 was 8 degree Celsius for maximize 15 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1809USA003709: US-009507513-1810USA001951: US-009507513-1810USA001952: US-009507513-1810USA001953: US-009507513-1810USA001954: US-009507513-1810USA001955: US-009507513-1810USA001956: US-009507513-1810USA001957: US-009507513-1810USA001959.
ache; tiredness; This spontaneous case was reported by a physician and describes the occurrence of PAIN (ache) and FATIGUE (tiredness) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included ADALIMUMAB (HUMIRA) for Crohn's disease.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN (ache) and FATIGUE (tiredness). At the time of the report, PAIN (ache) and FATIGUE (tiredness) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   On an unknown date, bloodwork was done, results unknown.
Patient presented to the ED on 4/2/21 and was subsequently hospitalized for 5 days.
45 y.o. male with a PMH of Anxiety and depression and asthma presented to hospital 1/13/2023 with Right MCA CVA. He received TNK and went to IR for thrombectomy with TICI3 reperfusion.