chrisvoncsefalvay/vaers-outcomes huggingface dataset:
CHILLS; This spontaneous report received from a patient concerned a 60 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included allergy to ceftin, iodine allergy, allergy to dye, and allergy to bactrim. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered in left arm on 25-MAR-2021 12:30 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 25-MAR-2021, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills on 25-MAR-2021. This report was non-serious.
Within 2 hrs of vaccine, developed red, raised induration from right shoulder extending down to near his elbow. Assoc sx include rigors, shaking chills. These sx continued for about 48 hrs when they fully resolved.
Hives, facial swelling, cough, wheeze approx. 5 minutes after administration. Tx. BENADRYL, Epinephrine, Albuterol, PRELONE sent to hospital via ambulance.
vaccine was frozen rather than refrigerated. patient was given dose. no symptoms reported. revaccination offered to patient.
Patient states she received COVID-19 vaccination on 03/05/2021. States later that night, her arm became"stiff and sore and couldn't move it or touch it". Rated pain at a 9/10 on Friday through Saturday. Reports pain was constant. States she did not lose range of motion, but "didn't move it because it hurt a lot". Reports she took ibuprofen every 4 hours and iced injection site throughout the weekend. Reports she "didn't do much on Saturday related to the pain". Reports "constant pain" improved late Sunday night. Describes injection site located "where the shoulder meets the arm at the top".
Tongue was swollen; It even affected her speech; Discomfort in arm; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (Discomfort in arm), SWOLLEN TONGUE (Tongue was swollen) and SPEECH DISORDER (It even affected her speech) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048a21a) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, the patient experienced LIMB DISCOMFORT (Discomfort in arm). On 28-Mar-2021, the patient experienced SWOLLEN TONGUE (Tongue was swollen) and SPEECH DISORDER (It even affected her speech). At the time of the report, LIMB DISCOMFORT (Discomfort in arm), SWOLLEN TONGUE (Tongue was swollen) and SPEECH DISORDER (It even affected her speech) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient's medical history was not provided.  No relevant concomitant medications were reported. Treatment information included Zyrtec, which softened the effect.
Allergic reaction; extreme itchy; hives; swollen hands; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: UNKNOWN) via unspecified route of administration on the left arm on 19Mar2021 at 03.45 pm (at the age of 45-years-old) as a single dose for COVID-19 vaccination. The patient had no relevant past medical history. The patient did not have any allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received unspecified medications within 2 weeks of vaccination. Since the vaccination, the patient had not been tested for COVID-19. On an unknown date in Mar2021, the patient developed allergic reaction which was extreme itchy, hives and swollen hands and feet. Therapeutic measure included the use of BENADRYL for the treatment of the adverse events. The clinical outcome of the event allergic reaction involving events itchy hives, swollen hands and feet was recovering at the time of report.  No follow-up attempts are possible. Information about lot number cannot be obtained.
Pain symptoms sinilar to tennis elbow. Pain in elbow. Difficult to lift objects.
vertigo/woke up and the room was spinning, like on a carnival ride; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 30Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VERTIGO (non-serious) with onset 31Mar2021, outcome "unknown", described as "vertigo/woke up and the room was spinning, like on a carnival ride". Additional information: The patient stated that she never experienced that before and asked if that was normal and if it was safe to receive the second vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Breathing issues 20 hours later; Sore throat for 3 weeks; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 18Aug2021 at 15:30 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient had unspecified allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive other vaccines within four weeks prior to the vaccination. On 19Aug2021 at 11:30, 20 hours later, the patient experienced breathing issues and on an unknown date in Aug2021, she had sore throat for 3 weeks. The events did not result in a visit to the doctors or other healthcare professional office/clinic, 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 events breathing issues was resolved with sequelae on an unknown date in 2021 while sore throat for 3 weeks was resolved with sequelae in Sep2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I had a knot under the skin that was spreading with spreading red and heat in it and looked like an orange on top.  It was trying to develop cellulitus at the injection site.
patient received lst dose of pfizer , 2nd dose of moderna.  no rxn, pt went home
I started having heart flutter and heart palpitations, quite strong, the morning after receiving the Moderna Spikevax vaccine.  I have PVCs anyway but they are typically controlled by medication.  These heart palpitations are unpleasant but I believe they are not dangerous to me
RASH ON THE ARM; HEADACHE; CHARLIE HORSE FROM ARM TO BACK OF HEAD, BEHIND RIGHT EAR; This spontaneous report received from a patient concerned a 38 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 12-APR-2021, the subject experienced charlie horse from arm to back of head, behind right ear. On 12-APR-2021, the subject experienced headache. On 13-APR-2021, the subject experienced rash on the arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from rash on the arm, charlie horse from arm to back of head, behind right ear, and headache. This report was non-serious. The suspected product quality complaint has been confirmed to be voided did not meet PQC criteria based on the PQC evaluation/investigation performed.
Tongue started tingling at 9 minutes, then sensation moved to throat, wheezing and tongue swelling Benadryl, inhaler, epi pen, steroids Approximately at 12 hours later developed painful blisters with black dots, tongue white, and painful. Food tastes differently metallically
Suspected vaccination failure / got a Shingrix shot a month ago and was diagnosed with shingles yesterday; Shingles; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   In December 2019, the patient received Shingrix. On 8th January 2020, less than 2 months after receiving Shingrix, 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 recovering/resolving.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The age group was not reported, but was selected adult as per vaccine indication. The patient got a Shingrix shot a month ago and was diagnosed with shingles on day before reporting. The patient was not very happy that a shingles shot apparently gave him or her shingles. The patient's primary care physician suggested that to get the shingles shot so he or she did and on day before reporting had shingles. This case was considered as suspected vaccination failure as details regarding full vaccination schedule was unknown at the time of reporting. The reporter did not consent to follow up.
Information has been received from a consumer concerning a "72 year old" female patient with penicillin allergy and codeine allergy and a history of "Raynaud's" and "emphysema" who on "14-OCT-2008" was vaccinated with PNEUMOVAX (lot 661529/0868X). Concomitant therapy included Influenza virus vaccine (unspecified) on the other arm with no reaction, PROCARDIA and an inhaler. Prior vaccinations included a pneumonia vaccine (manufacturer unknown) 10 years ago. On 15-OCT-2008 the patient started experiencing headache, joint pain, loss of appetite and just feeling sick all over. The patient's arm also swelled up and was 3 times the size and very painful and red. After the swelling subsided the patient had bruising at the elbow area. The patient started taking BENADRYL and steroids. The patient also started developing a rash on her arm and started loosing weight. The patient eventually developed a viral infection in her lungs. The patient was finally getting over the infection and started feeling much better but is not yet fully recovered. The patient had sought unspecified medical attention. Additional information has been requested.
Woke up day after vaccine, thought i had broken ribs, this went on for about 72 hours, then a few days of ok and then  walking up my 3 stairs to my house, i got dizzy, my eyes went black and white abd squiggly, instantly massive headache, and stomach aches, my bones hurt thruout my torso... ongoing headaches, Tired all the time, my eyes are blurry alot, Very shaky all the time, loss of appitite, brain fog, back aches
History of diffuse large cell B cell lymphoma, dementia, Parkinson's disease, paroxysmal A. fib, previous Covid infection.  She was recently admitted to the hospital with a prolonged course with respiratory failure, pneumonia, was treated empirically for potential PCP pneumonia as well as multiple other acute issues that she was very significantly ill and then went to subacute rehab.  She now presents on 8/5 with abdominal pain, colitis, sepsis due to Enterococcus bacteremia.  Possible COVID- unclear if false positive/shedding vs true positive.   Tested positive for C. diff. on 8/6.  Treated with Zosyn for Enterococcal bacteremia + enteric pathogens as well as PO vancomycin x10 days for C. diff.  No targeted COVID therapies as oxygenation adequate and pt is otherwise stable.
Grade 3 swelling, tenderness and redness at injection site from day 1 through currently  day 8 post vaccination with no improvement.
myself had the virus at the end of Jul; myself had the virus at the end of Jul; menstrual period disappeared /came back again in May and I have not had it ever again; This is a spontaneous report from a contactable pharmacist (patient). A 43-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot/batch number was not reported) via an unspecified route of administration on 27Jan2021 (age at vaccination was 43 years) as dose number unknown, single for covid-19 immunisation. The patient's medical history included diabetes type l. The patient's concomitant medications were not reported. She received Insulin pump within 2 weeks of vaccination. She did not receive any other vaccines within 4 weeks prior to the covid vaccine. After receiving the vaccine, her menstrual period disappeared. She used to have a stable cycle. After the vaccine, it went away for two months, came back again in May and she had not had it ever again on 01Feb2021. There had been no stress related to Covid in her case. She had not stopped working or lost a relative or close friend because of the virus. She herself had the virus at the end of July with no major complications just as her unvaccinated husband and three children. The adverse event resulted into doctor or other healthcare professional office/clinic visit. The patient underwent lab test and procedure included nasal swab (SARS-CoV-2 test) and resulted into positive. She did not receive treatment for adverse events. There were no known allergies. She had not diagnosed for covid-19 prior vaccination and not tested for covid-19 since the vaccination. The outcome of events was not recovered.  The lot number for the vaccine, [BNT162B2], was not provided and would be requested during follow up.
The pt had an injection site reaction a red band went around her arm and she had a rash in her armpit. Also she had flu like reaction for 12 hrs (this was right arm), she took Benadryl and was fine her husband is MD.
This spontaneous report as received from a consumer refers to her husband, a 51 years old male patient with insulin-dependent type 1 diabetic and aspirin allergies. The patient was vaccinated with lot # (667912/0933Z exp date 25-FEB-2012), 0.5 ml PNEUMOVAX 23 (IM or SubQ) for routine vaccination on 05-SEP-2012 2:30 pm. Concomitant medications included insulin, BENICAR and LIPITOR. After vaccination, on 05-SEP-2012, the patient immediately had severe arm pain, followed by severe chest congestion and coughing that occurred 12 hours after. The patient did not seek medical attention, (2) extra strength TYLENOL was given for the adverse events. None lab diagnostics was performed, the adverse events were not improved. The outcome of severe chest congestion, coughing that occurred 12 hours after and severe arm pain was reported as not recovered/not resolved. Additional information has been requested.
some kind of reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (some kind of reaction) in a female patient of an unknown age 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (some kind of reaction). At the time of the report, VACCINATION SITE REACTION (some kind of reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. No Treatment medications were reported.
In November 2022, I came down with COVID-19. I didn't feel like I had it severely except for excessive coughing. It has persisted still. I still have a cough from COVID-19. I went to my PCP around the end of January 2023 to get something for the cough. It was obvious it wasn't going to go away. I had been taking Delsym every 12 hours two weeks prior before contacting the doctor. I started with a virtual visit and I was given 3 prescriptions. I took them all within 2-4 days and the coughing came back. I went in and saw her the next time and was given another prescription. Same thing, as soon as the prescription was over, the cough came back. She said that we could do a chest x-ray. The chest x-ray noted  a 1.9 cm nodule on my upper right lung. The doctor then said she wanted to do a CT without contrast. They did that a week later and at that time, she gave me a z-pack for 5 days and said they wanted to repeat the CT in 30 days. We did the repeat CT, and the nodule had not changed. I was sent to a pulmonologist. He noted that the comparison from the two CT scans, from the first one CT I had COVID-19 pneumonia. The pneumonia was gone but the nodule was still there in the the second CT. The pulmonologist sent me for a PET scan, and they're going to do a bronchial biopsy. He does not believe that the COVID-19 infection had anything to do with the nodule. He suspects it may be cancerous. He also noted that a fungal infection looks the same as a cancerous nodule, but we won't know until the biopsy. The COVID-19 stripped a coughing nerve that has caused me to cough a lot more. That could last anywhere from 8 months to never healing. I'm currently on medication to help with this.
fever; vomiting; nauseau; fatigue; cough; depression; sore throat; This is a spontaneous report received from a contactable reporter(s) (Nurse).  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Sep2021 as dose number 3 (booster), single (Lot number: FF8839) at the age of 52 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "cold agglutenin syndrome" (unspecified if ongoing); "environmental allergies" (unspecified if ongoing). Concomitant medication(s) included: BUPROPION HCL oral, start date: 31Dec2010, stop date: 27Jun2022; FEXOFENADINE HCL oral, start date: 31May2022, stop date: 27Jun2022. Vaccination history included: BNT162b2 (Pfizer / BioNTech vaccine dose 2; lot number: EL0140, Vaccine location: Left arm), administration date: 10Jan2021, for Covid-19 immunization, reaction(s): "COVID-19"; BNT162b2 (Pfizer / BioNTech vaccine dose 1, lot number: EJ1685, Vaccine location: Left arm), administration date: 20Dec2020, for Covid-19 immunization, reaction(s): "COVID-19". The following information was reported: OROPHARYNGEAL PAIN (non-serious) with onset 13Jun2022, outcome "recovering", described as "sore throat"; COUGH (non-serious) with onset 26Jun2022 at 07:00, outcome "recovering"; DEPRESSION (non-serious) with onset 26Jun2022 at 07:00, outcome "recovering"; FATIGUE (non-serious) with onset 26Jun2022 at 07:00, outcome "recovering"; PYREXIA (non-serious) with onset 26Jun2022 at 07:00, outcome "recovering", described as "fever"; NAUSEA (non-serious) with onset 26Jun2022 at 07:00, outcome "recovering", described as "nauseau"; VOMITING (non-serious) with onset 26Jun2022 at 07:00, outcome "recovering". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, vomiting, nausea, fatigue, cough, oropharyngeal pain, depression.  Additional information: The patient had symptoms of sore throat starting on 13Jun2022. Antigen was negative on the 13Jun2022. Tested positive on PCR on 14Jun2022. Symptoms were increased and included elevated fever, vomiting, nausea, fatigue, cough, sore throat, depression. As symptoms resolved, tested antigen negative on 23Jun2022 and 24Jun2022. Rebound of nasal congestion and sore throat symptoms and positive antigen test on 27Jun2022. The patient did receive other medications in 2 weeks prior to vaccine. Patient has Moderna covid vaccine as 4th dose with lot number 003J21-2A on 07Apr2022 in left arm. Patient had taken oral paxlovid, as COVID 19 treatment dated start date: 15Jun2022, to stop date: 19Jun2022, with lot number: NDC: 00069-1085-30.
Site: Pain at Injection Site-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Error: Shoulder Joint Injury (prolonged pain, tingling, etc.), Additional Details: Patient explained that he is still experiencing a burning pain in his left shoulder daily with some numbness and tingling in his fingertips occasionally when he moves his arm. He feels that the pain flares up when he lays down at night.
Vial contains .5ml and is labeled as "single dose", erroneously given full contents in vial as opposed to recommended dose of .25ml. Adverse reactions not yet reported.
Pt reports being nausous once she arrived home on day vaccine was given. She reports the nausea subsided after 2 days. The morning following vaccination, 3/18/18, she reports waking up with her lips very swollen. They remained swollen throughout the day and subsided on 3/19/18.
Pt came in for vaccine, pt recieved MMR, VZU, Prevnar, HepH, Pentacel et Flu vaccine. Pt returned two days later for redness in LT. Pentacel et Flue were given in LT.
heart rate increased; oxygen saturation decreased; dyspnoea exertional; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (heart rate increased), OXYGEN SATURATION DECREASED (oxygen saturation decreased) and DYSPNOEA EXERTIONAL (dyspnoea exertional) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product TREPROSTINIL SODIUM (TYVASO) for Pulmonary arterial hypertension.    Concurrent medical conditions included Pulmonary arterial hypertension.   On 02-Apr-2021, the patient started TREPROSTINIL SODIUM (TYVASO) (unknown route) .6 mg four times per day. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-May-2021, the patient experienced HEART RATE INCREASED (heart rate increased), OXYGEN SATURATION DECREASED (oxygen saturation decreased) and DYSPNOEA EXERTIONAL (dyspnoea exertional). At the time of the report, HEART RATE INCREASED (heart rate increased), OXYGEN SATURATION DECREASED (oxygen saturation decreased) and DYSPNOEA EXERTIONAL (dyspnoea exertional) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by investigator  No treatment medications provided by the reporter   Most recent FOLLOW-UP information incorporated above includes: On 13-Jun-2021: Follow-up received, email response included NNi
No additional AE reported; the vaccine expired on 28-NOV-2021, but was administered to the patient today; This spontaneous report was received from a nurse practitioner referring to a patient of unknown age and gender. Information about pertinent medical history, drug reaction/allergy and concomitant medication was not provided.      On 18-JAN-2022, the patient was administered an expired dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (0.5 mL, lot # 1621926, expiration date 28-NOV-2021; strength, route of administration and anatomical location were not reported) for prophylaxis (expired product administered). The reporter confirmed the vaccine had no temperature excursions. No additional adverse event (AE) or product quality complaint (PQC) was reported.