chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Feb2021 as dose 1, single (Lot number: ENG 202) at the age of 53 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Lupus" (unspecified if ongoing); "Arthritis" (unspecified if ongoing); "Rheumatoid arthritis" (unspecified if ongoing); "High blood pressure" (unspecified if ongoing), notes: High blood pressure. The patient's concomitant medications were not reported. Past drug history included: Imuran, reaction(s): "Allergy_Imuran", notes: Allergy_Imuran; Plaquenil, reaction(s): "Allergy_Plaquenil", notes: Allergy_Plaquenil; Lisinopril, reaction(s): "Allergy_Lisinopril", notes: Allergy_Lisinopril. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient taking any other medication within 2 weeks of COVID vaccine reported as Meds for high blood pressure and lupus. Patient previously received COVID-19 vaccine.  No follow-up attempts are possible. No further information is expected.
On July 11,2021 my arm was sore an at different times numb I was very fatigued an nauseous than on the morning of July 12,2021 my face swelled I took a Benadryl that relieve it but than again during the day it swelled again an my lips so I took another Benadryl I also had trouble sleeping very restless than July 14, 2021 I woke up several times sweating with my hair wet from sweating an still nauseous.
Hep A injection at 18 month physical. Approx. 4-6 hrs after pt started with hives and swelling at injection site which then spread to leg, abdomen and back. BENADRYL given.
racing heart (pulse 115), shortness of breath, vomiting, headache, itchy painful rash/hives.  Both #1 and #2 injections gave me the COVID arm.  Have ongoing headache still since these events, and extreme tiredness.
hives since about 06:00 3DEC98-covering face, stomach, back;resolving by about 10:00;
Patient received second Pfizer booster. She reported prior to administration that she faints for approximately five minutes each time she receives the Covid vaccine. She fainted upon injection and was unconscious for 3.5 minutes. After this period, she was comfortable and conversing. Vitals were monitored for one hour post-administration and were stable.
Pt has back and arm pain spreading diffusely over body. without documented fever or nausea/vomiting, no shortness of breath. Pt complains of chills dyspnea "hot feeling". Physical exam unremarkable with possible LA post mandibular LN. Vaccine site pustule scab 0.5cm, possible satellite lesions with erythema 3X4cm. Motrin alternate with tylenol, ATC.
Pruritic rash, listless, discomfort site rash. Rt periorbital edema. Erythema multiforme rash, cheek, rt arm. Hyperpigmentation almost vasculitic appearing, nodules. 4/27/07 Received medical records from hospital which reveal patient experienced itchy rash of both arms, left cheek & swelling around left eye.  Rash then spread to right cheek & right eye & became painful.  Seen by PCP who admitted to hospital 4/17-4/18/07.  Rash on admit was mostly macular, noted to be angry at Varivax site.  Rash had purpuric/vasculitis look.  Both eyes swollen & skin pale & tender.  Nasal crusty.  Tx w/IV antibiotics & d/c to home on continued oral antibiotics FINAL DX: Erythema multiforme rash, most likely allergic reaction, possibly to Varivax; periorbital swelling/cellulitis.
This spontaneous report was received from a registered nurse refers to unspecified patients of unknown demographics. No medical history was reported. On an unknown date, unspecified number of patients were vaccinated with PNEUMOVAX 23 (dose, route and frequency unspecified) which was improperly stored since 01-FEB-2014. No concomitant medications were reported. Nurse did not have any patient specific information. No adverse effects were reported. No further information was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Red circle around injection site that turned into a red circle surrounded by a larger red circle.  Arm and joint pain over the last couple days (nearly 1 week later).  Now (9 days after injection), still has dark red/bruise looking circle.  Still ongoing.
Fever; Chills; Headache; Myalgia; This case was reported by a consumer via call center representative and described the occurrence of fever in a 59-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included RECOMBINANT VARICELLA ZOSTER VIRUS SURFACE GLYCOPROTEIN E (SHINGRIX).   On 24th May 2022, the patient received the 2nd dose of Shingrix. On 24th May 2022, less than a day after receiving Shingrix, the patient experienced fever, chills, headache and myalgia. On an unknown date, the outcome of the fever, chills, headache and myalgia were not recovered/not resolved.   It was unknown if the reporter considered the fever, chills, headache and myalgia to be related to Shingrix.     Additional Information: GSK Receipt Date: 25-MAY-2022 Reporter's comment: The case was self reported by the patient. The patient reported that he received the second dose of Shingrix vaccine and that evening after receiving his second dose patient developed side effects such as fever, chills, headache, and myalgia. Till the time of reporting, symptoms were not resolved.  Offered medical advise disclaimer. The reporter did not consent to follow-up.
Moderna COVID-19 Vaccine EUA. It?s been a week since vaccine and injection site is red,bumpy, and and itchy. My body has been feeling somewhat itchy but not sure if it could be related to that too.
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 injection (lot # M002252 with expiry date: 28-FEB-2017, orally; strength, dose and site of administration were unspecified). The administered vaccine underwent the temperature excursion at 8.3 degrees Celsius for 19 minutes. There was no previous temperature excursion. It was a case of a "data logger". 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.
stroke with worse deficiency in right arm-weak, very little use in arm/hand as of 21May2021; right arm, soreness in arm; neck and shoulder pain began along with weakness in right arm; neck and shoulder pain began along with weakness in right arm; neck and shoulder pain began along with weakness in right arm/ with worse deficiency in right arm-weak, very little use in arm/hand as of 21May2021; General body weakness; This is a spontaneous report received from a contactable consumer (patient). A 91-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), at the age of 91-year-old, via an unspecified route of administration, administered in arm right on 18Feb2021 at single dose for COVID-19 immunisation. Medical history included arthritis. Known allergies: amoxicillin. Concomitant medication included verapamil HCL; furosemide, potassium chloride (LASIX + K); colecalciferol (VIT.D3); magnesium oxide (MAGOX); atorvastatin calcium; warfarin. The patient previously received the first dose of BNT162B2 on 28Jan2021 at the age of 91-year-old for COVID-19 Immunisation, no issues whatsoever. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had been tested for COVID-19 since the vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced stroke with worse deficiency in right arm-weak, very little use in arm/hand as of 21May2021 on 24Feb2021 02:00, right arm, soreness in arm on 21Feb2021  , neck and shoulder pain began along with weakness in right arm on 21Feb2021, general body weakness on 21Feb2021. Adverse events resulted in emergency room/department or urgent care, hospitalization (in 2021 for 3 days), life threatening, disability or permanent damage.  It was unknown whether treatment received for the events. The patient underwent lab tests and procedures which included Covid test type post vaccination: blood test: negative in 2021. The outcome of the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Information has been received from a physician concerning a 33 year old male with an allergy to penicillin who on 2/1/01 was vaccinated with the 1 dose of varicella virus vaccine live (lot 636569/0926K). On 2/7/01, the pt experienced hives and not a varicella-like rash. The rash was non-raised. He was seen in the ER. Upon medical review, the hives were determined to be an "Other Medical Review". The pt was treated with a steroid and Benadryl, but did not have much relief. Additionally, on 2/9/01, the pt experienced swelling in his joints and serum sickness-like symptoms. The pt's hives persisted. The outcome of the pt's other experiences was not reported. No further information is available.
Shoulder/ injection site was sore and hurting.  Thought it would go away.  Could not sleep one that side and pain would wake me up.  Mobility of arm kept getting less and less even with stretching.  Could not do simple/everyday movements.  Finally went to Dr. and have frozen shoulder.  Going to physical therapy and still can not get full mobility back and still have problems sleeping as when I move arm it hurts.   Prior to this I was able to do my yoga posses with my arm with no problem.  Feels like my muscles are ripping and have lump in injection area.
Headache, Myalgia, Shoulder pain and swelling, chills, stiff neck and  fatigue Narrative:  Other Relevant History:
has knot in his arm; lump; his is actually on the outside on his arm; This is a spontaneous report from a contactable consumer or other non hcp (patient s wife). This is the first case out of two cases.  A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EL9269), via an unspecified route of administration on 05Feb2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient has knot in his arm, lump, his was actually on the outside on his arm on an unspecified date. Reporter stated, patient had our shot of the Pfizer vaccine (Clarified as Covid vaccine) on 05Feb2021 and so his arm was sore for day and a half and her husbands was not, but now he had knot in his arm, was that common to have a lump there. Yes, it was on the arm and I have been looking all information and patient know something that happen with arm pit but his was actually on the outside on his arm where he had the shot little bit below where he had the shot. The outcome of the event was not resolved at the time of this report.  Follow-up attempts completed. No further information expected.
This spontaneous report has been received from a nurse referring to an unspecified number of patients of unknown age and gender. No information was provided regarding to the patients' medical history, concurrent conditions, and drug and allergy history. On an unknown date, an unspecified number of patients were vaccinated with improperly stored doses of VARIVAX, subcutaneously, lot # N000682, expiration date 06-JUN-2019, and lot# M049126, expiration date 15-DEC-2018, for prophylaxis, which were reconstituted with properly stored diluent MRK (lot# and expiration date were not provided). The doses of VARIVAX were exposed to a temperature excursion of -9°Celsius (°C) to 8°C (-7.5°C) during a time frame of 6 hours, which was detected by the data logger. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1706USA009579.
Gave PT FLUARIX PF vaccines - PT reported a red/swollen knot 2 days later. Also reported the feeling of irregular heart beat soon after the vaccine. PT also reported insomnia the night of the vaccine.
Soreness & lump in left lower thigh  size of tic tac  Swollen and sore left foot Diagnosed with ultrasound as superficial blood clot  Heat applied and aspirin  Still swollen
About 6 days after the 1st shot I experienced severe pain in my joints and muscles which lasted approximately 24 hours then resolved completely. The same thing happened after the 2nd shot (received 3/5/21).   However about 4 days after the second bout resolved, the pain began again (3/11/21) and worsened steadily to the point of debilitation until 5/19/21 when a diagnosis of polymyalgia rheumatica was made and I began treatment. Also on 4/17/21 I began to have a low grade fever and night sweats.
Arm soreness; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm soreness) and FATIGUE (Fatigue) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.    Co-suspect product included non-company product LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) for an unknown indication.    Concurrent medical conditions included Cholesterol and Osteoporosis. Concomitant products included ATORVASTATIN for Cholesterol, CALCIUM CITRATE for Osteoporosis, VITAMIN D3 and TOCOPHEROL, UBIDECARENONE, ZINC (COENZYME Q10+) for Supplementation therapy.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On an unknown date, the patient started LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) (unknown route) at an unspecified dose. On 23-Jan-2021, the patient experienced PAIN IN EXTREMITY (Arm soreness) and FATIGUE (Fatigue). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) at an unspecified dose and frequency. On 24-Jan-2021, PAIN IN EXTREMITY (Arm soreness) and FATIGUE (Fatigue) outcome was unknown.            Treatment medication include: Anti itch cream                                                  eye drops.   This case was linked to US-MODERNATX, INC.-MOD-2021-066665, US-MODERNATX, INC.-MOD-2021-067694 (E2B Linked Report). This case was linked to MOD-2021-066665 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 23-Apr-2021: patient information added. On 24-May-2021: Email stated FUP was sent via fax On 24-May-2021: Initial Additional-2 : Unable to fax.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-066665:MOD-2021-066647 -1st dose of Vaccine US-MODERNATX, INC.-MOD-2021-067694:Crosslinked (MOD21-068818)
nausea, vomiting, myalgias, chills. Did not take temperature. Severe fatigue for three days.
I had it 3 times after I took the shot!/ suspected vaccination failure; I had it 3 times; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient reported case for herself/himself. The age at vaccination was not reported. The patient stated he/she had shingles 3 times after the patient took the shot. This case was considered to be a suspected vaccination failure case, as the details regarding being full vaccination schedule, laboratory confirmation for shingles and exact time to onset were unknown.
covid symptoms; Covid Symptoms; This is a spontaneous report received from a contactable consumer (patient). This is one of the 2 report from same patient. A 73-Year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN6208) dose 2, via intramuscular route of administration on upper left arm on 11Mar2021 15:00 at single dose for COVID-19 immunization. On 01Jul2020 to 09Jul2021 the patient medical history included, Positive Covid 19, Fever, Chills, No appetite, diarrhea, body headache. The patient concomitant medications were not reported. The patient received bnt162b2, (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN6201) dose 1 via Intramuscular route of administration on upper left arm on 18Feb2021 15:00 at single dose for COVID-19 immunization and experienced Covid Symptoms on 19Feb2021 03:30, received treatment (Tylenol) for adverse event. On 11Mar2021 12:00 the patient experienced covid symptoms after second dose. The patient underwent lab tests and procedures which included sars-cov-2 test: Positive on unknown date in 2021. The patient received treatment (Tylenol) for adverse event. The patient recovered from the events on 13Mar2021.  Information on Lot/Batch number was available. Additional information has been requested.
Patient received SHINGRIX on 3/23/18 and called in to speak to a nurse on 3/25/18 to report fatigue, red area less than the size of her palm on her right arm. Red area is less than the size of her palm, warm to touch. Patient also reported raised bumps and closed blisters in the red area which is approximately 5 inches below injection site. Patient reports red area is tender, aching. Per office visit with physician on 3/26/18: Redness and blisters 5" beneath site of injection. Has chronic dizziness and the day after the shot she felt fatigued but dizziness was stable. Was able to exercise the day of and next day after immunization. No SOB, wheezing, throat swelling. Had shingles about 8-9 years ago. Then had ZOSTAVAX. Follow up phone call with nurse on 4/4/18: Patient states received the SHINGRIX vaccine 13 days ago. Three days following the vaccine had an OV to evaluate red arm on arm. Verified that it was a reaction from the vaccine. Starting about 4-5 days ago noticed on the right side of her trunk and under right arm bright red bumps. There is a second red area across her chest with bumps. Areas are not painful but very itchy. Has not tried anything for the itchiness. There is also an area on the top of her head "right at midline" that is very itchy, does not feel any bumps. Symptoms were the worst on Tuesday and Wednesday of this week, seem to be slightly improved today.
horrible cough; ran a temperature; diarrhea; all the symptoms of Covid; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (horrible cough), BODY TEMPERATURE INCREASED (ran a temperature), DIARRHOEA (diarrhea) and SUSPECTED COVID-19 (all the symptoms of Covid) 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.    In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COUGH (horrible cough), BODY TEMPERATURE INCREASED (ran a temperature), DIARRHOEA (diarrhea) and SUSPECTED COVID-19 (all the symptoms of Covid). At the time of the report, COUGH (horrible cough), BODY TEMPERATURE INCREASED (ran a temperature), DIARRHOEA (diarrhea) and SUSPECTED COVID-19 (all the symptoms of Covid) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported. No treatment reported. Consumer states that had the Moderna shot in Mar2021 and Apr2021 She mentioned that after the 1st one; the day after the shot had a horrible cough, went downhill from there. She ran a temperature, had diarrhea and all the symptoms of Covid. Company comment This case concerns a patient of an unknown age and gender, with no reported medical history, who experienced the unexpected non-serious events of COUGH, BODY TEMPERATURE INCREASED, DIARRHOEA and SUSPECTED COVID-19. The events occurred om the following day after the administration of the first dose of mRNA-1273 vaccine. She ran a temperature, had diarrhea and all the symptoms of Covid. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a patient of an unknown age and gender, with no reported medical history, who experienced the unexpected non-serious events of COUGH, BODY TEMPERATURE INCREASED, DIARRHOEA and SUSPECTED COVID-19. The events occurred om the following day after the administration of the first dose of mRNA-1273 vaccine. She ran a temperature, had diarrhea and all the symptoms of Covid. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
On 01-24-2021, I went into the hospital because I had fever and chills.  I also experienced soreness in my left arm with body aches in my joints. Lab work was performed at the hospital. I stayed at the hospital 7 days.
My Family health provider recommended to file this event. Roughly one hour after my second dose of Moderna Covid vaccine, my both legs started to feel cold, tingling and some kind of numb, like sleeping. Over time, 4 hrs, the tingling stayed in the feet the legs feel pressed and tight, including the upper legs now. Temp is at 38.5, moderate headache and moderate belly pain go along with it. The feet especially the toes are colder than the rest, legs temp feels normal. There was no treatment ordered by the Dr.
Patient received Janssen COVID vaccine on 5/28/21 (lot # 041A21A) and Moderna COVID vaccine on 1/22/22 (lot # 013H21B). On 1/18/22, patient admitted to our inpatient facility (med/surg unit) for acute hypoxemic respiratory failure and pneumonia due to COVID-19. As of today (1/21/22), patient is still admitted in the med/surg unit.
I woke up one morning having a little more trouble breathing than usual. I was wheezing. Throughout the day, I felt tired. The next morning, I woke up with the same symptoms, plus a headache. I took a home antigen test and got a positive result. Later that day, I had a telehealth visit, and I was prescribed PAXLOVID. At this point, I had body aches, wheezing, fever of 101, and headache. I began taking PAXLOVID on the evening of 1/28/2023. I had wheezing and chills throughout the night. When I woke up on 1/29/2023, I felt a significantly better. My headache was gone, my breathing was better, and my fever had subsided. I continued to improve and felt increasingly better for the next several days. On 2/6/2023, I took another home antigen test and got another positive result, but at that point, I felt fine. I have not tested myself again since then.
At 30 min observation time pt. Advised medics that she had hoarseness and scratchy throat.  Medics in obs. lot did initial eval, and FIre/Rescue EMS summonsed (SMFRA) via 911 for potential allergic/anaphylactic reaction.  Vital signs were BP 180/100, P82, Pox99% on RA  and  R20.  Pt was evaluated also by fire/EMS and patient encouraged to seek medical attention via ambulance.  Pt. refused transport to facility but agree to go POV.  Pt. had total time pre obs/post obs of approx one hour with no worsening of s/s.  Pt. was release AMA with advisement of not seeking medical attention could lead up to death.  Pt. accepted risks.  Pt. also advised to advise PCP.