chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Coughing 24/7; fever; Cold; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 34-year-old male patient received BNT162b2 (BNT162B2), on 10Apr2021 as dose 1, single (Lot number: EW0162) at the age of 34 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications.  The following information was reported: NASOPHARYNGITIS (disability) with onset 15Apr2021, outcome "not recovered", described as "Cold"; COUGH (disability) with onset 15Apr2021, outcome "not recovered", described as "Coughing 24/7"; PYREXIA (disability) with onset 15Apr2021, outcome "not recovered", described as "fever". Therapeutic measures were taken as a result of cough, pyrexia, nasopharyngitis.   It was reported that patient was coughing 24/7, fever every month, cold, every month or other. Patient did not receive other vaccines in four weeks and did not receive other medication in two weeks. Prior to vaccination, patient has not had COVID-19 and was not tested for COVID-19 post vaccination.; Sender's Comments: Based on available information, a possible contributory role of the subject product BNT162b2 vaccine, cannot be excluded for the reported events due to temporal relationship. However, the reported events may possibly represent intercurrent medical conditions in this patient. There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics including  chest x-ray, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Weakness, exhaustion, sore throat, fever, pain, redness, rash, itchiness and swelling at the injection site,  chills, and headache treated with rest, Advil, Tylenol, Benadryl, and ice
Information has been received from a registered nurse concerning a male who was vaccinated (on an undisclosed date) with zoster vaccine live (Oka/Merck), and about "three months ago," in approximately 2007, the patient developed neuralgia after receiving zoster vaccine live (Oka/Merck). The patient was seen by his physician for the pain, and treated with unspecified pain medication. At the time of reporting the patients current status was unknown. There was no product quality complaint.
AFTER 2 WEEKS OF SECOND DOSE OF MODERNA BOOSTER SHOT, MY ENTIRE BODY STARTED FEELING EXTREMELY WEAK AND FATIGUE, ALL BODY MUSCLES GOT TENSED. MY HANDS STARTED STIFFED INCLUDING FEET. I COULD NOT ABLE TO WALK AT ALL SO I WENT TO HOSPITAL EMMERGENCY DEPARTMENT TO RUN THE BLOOD WORK AND REST OF THE TESTS TO FIND OUT . I HAVE ALL THE REPORT IN MY POSSESION TO JUSTIFY THE CAUSE OF THE ROOT WAS BOOSTER SHOT OF MODERNA 2ND SHOT. I DEVELOPED GUILLAIN-BARRE SYNDROME.
Patient states he felt "a rush," his cheeks felt warm and flushed, and his tongue had a "tingling feeling."
Second does of Pfizer Covid-19 vaccine received on April 1, 2021 at 8:45am in the right arm (first dose was 3 weeks prior in the left arm). By 2:30pm, tinnitus developed in my left ear. I have historically had some bouts of tinnitus in the left ear, but not in the past 12 months.   It has been 72 hours (4/4/21) and the tinnitus is persisting. The sound has increased in volume.
Every time I pick something up with my left arm it hurts; I can not lift my arm up, over my head/ I am basically disable on my left side; I am so hindered; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Every time I pick something up with my left arm it hurts), LIMB DISCOMFORT (I can not lift my arm up, over my head/ I am basically disable on my left side), DECREASED ACTIVITY (I am so hindered) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 088021A, 029L20A and 042L20A) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE, ATORVASTATIN CALCIUM (LIPITOR), OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]), METOPROLOL and VITAMINS NOS for an unknown indication.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Aug-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On an unknown date, the patient experienced PAIN IN EXTREMITY (Every time I pick something up with my left arm it hurts), LIMB DISCOMFORT (I can not lift my arm up, over my head/ I am basically disable on my left side) and DECREASED ACTIVITY (I am so hindered). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency and CYCLOBENZAPRINE HYDROCHLORIDE (FLEXERIL [CYCLOBENZAPRINE HYDROCHLORIDE]) on 04-Sep-2021 for Relaxation, at an unspecified dose and frequency. On 14-Aug-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved. At the time of the report, PAIN IN EXTREMITY (Every time I pick something up with my left arm it hurts), LIMB DISCOMFORT (I can not lift my arm up, over my head/ I am basically disable on my left side) and DECREASED ACTIVITY (I am so hindered) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Other Concomitant product included Ellipta.  The patient was not able to lift arm up over head and every time, after trying to pick something up, it hurts.  On 04-Sep-2021, the patient visited urgent care. There was nothing wrong, except for the shot.  On the same date, the patient took treatment medication, anti inflammatory injection (Flexeril to relax it, and pain medication).   This case was linked to MOD-2021-320261, MOD-2021-320166 (Patient Link).
Mother reported hive-like eruption around neck, at injection site, on thighs immediately following injection. Child also stated some difficulty breathing that passed.
This is a spontaneous report from a contactable medical assistant (Other HCP). A 64-year-old female patient received on 24Mar2014 at around 14:30 PREVNAR 13 (Lot Number: H79005, Expiration Date Sep2014, NDC number0005197102) at 0.5ml single dose intramuscular in right arm. Relevant medical history was none. Relevant concomitant medications included multivitamins that she was taking them during the onset of the events. Vaccines given on the same day and within the last four weeks were none. In the last week of Mar2014, after vaccination, she had a large local reaction on the site of injection which she mentioned as redness and swelling in her right arm due to which she was sent to emergency room in Mar2014 and they thought she had strep infection. Therapeutic measure in response to thought she had strep infection included unspecified antibiotic. Relevant lab data was none. At the time of report clinical outcome of "thought she had strep infection" was unknown. At the time of the report she had not recovered from other events. Follow-up (30MAY2014): Follow-up attempts completed. No further information expected.
left upper kidney pain.; Kidney has continued throbbing; I started a heavy period which I have not had in years since I am on the Nuvaring; Also included cramping and left breast pain that continued for a week; Also included cramping and left breast pain that continued for a week; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 27Jul2021 10:00 (Lot number: Fa6780) at the age of 48 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: NUVARING. The following information was reported: PAIN (non-serious) with onset 04Aug2021 09:00, outcome "not recovered", described as "Kidney has continued throbbing"; HEAVY MENSTRUAL BLEEDING (non-serious) with onset 04Aug2021 09:00, outcome "not recovered", described as "I started a heavy period which I have not had in years since I am on the Nuvaring"; MUSCLE SPASMS (non-serious), BREAST PAIN (non-serious) all with onset 04Aug2021 09:00, outcome "not recovered" and all described as "Also included cramping and left breast pain that continued for a week"; RENAL PAIN (non-serious) with onset 06Aug2021, outcome "not recovered", described as "left upper kidney pain.". The events "kidney has continued throbbing", "i started a heavy period which i have not had in years since i am on the nuvaring", "also included cramping and left breast pain that continued for a week", "also included cramping and left breast pain that continued for a week" and "left upper kidney pain." were evaluated at the physician office visit. Therapeutic measures were not taken as a result of pain, heavy menstrual bleeding, muscle spasms, breast pain, renal pain.  Additional information: The patient did not have any other vaccine on same date and no other medications in two weeks. The patient did not have covid prior vaccination and was not tested covid post vaccination. The patient did not have any other vaccine in four weeks. The patient did not have allergies that she was aware of. Clinical course: It was reported that 8 days later, patient started having a heavy period which she had not in years since she was on the Nuvaring. Also included cramping and left breast pain that continued for a week. On 06Aug2021 (day 10), she started having her left upper kidney pain. On 17Aug2021, the kidney has continued throbbing.  No follow-up attempts are possible. No further information is expected.
Approx 5 min after administration of vaccine, patient was sitting  in post vaccine waiting area when she fainted. Customers near the waiting area  assisted her while alerting the pharmacist. She was regaining consciousness as I got to her side. Assisted her to chair, gave Gatorade and candy then later cold bottle of water. Patient stated she was having waves of "hot flashes and nausea" which remained constant over the next 30-45 minutes. She called her husband to drive her home.  She left with him at approx. 7:15 pm.
stomach cramps; pink stain on toilet paper; experienced jolt upon administration; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (stomach cramps), ANAL HAEMORRHAGE (pink stain on toilet paper) and TREMOR (experienced jolt upon administration) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0476214) for COVID-19 vaccination.     Concurrent medical conditions included Allergy (The allergy was not specified.).    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, the patient experienced ABDOMINAL PAIN UPPER (stomach cramps), ANAL HAEMORRHAGE (pink stain on toilet paper) and TREMOR (experienced jolt upon administration). At the time of the report, ABDOMINAL PAIN UPPER (stomach cramps), ANAL HAEMORRHAGE (pink stain on toilet paper) and TREMOR (experienced jolt upon administration) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient was reported to be on an unspecified concomitant medication for an unknown indication.
High fever and chills.  Body aches, headache, itching on hands and feet/ankles.  Fatigue for 2 days.
5-6 hrs after the shingles shot I developed severe headache and neck pain; muscle pain all over my body, high fever, chills, severe fatigue, unable to move and stayed in bed 36 hrs and felt weak for one week, soreness, redness, swelling at area of injection. I received new shingle shot at pharmacy care clinic on Sept 7, 18 and a few hrs later I developed severe headache, neck pain, muscle pain all over my body, weakness and spasm in lower legs high fever, chills, fatigue, soreness, redness, swelling in the area of injection. I did stay in bed for 36 hrs, unable to go bathroom or drink water or make a telephone call. On Sept 10th left the message for my primary care physician, I did not have problem with old shingle shot.
Swelling of entire arm took BENADRYL and swelling subsided over next 2 days difficult to bend or use arm.
a physician administered an expired Pentacel to a baby, No AE; Initial information received on 01-Jul-2021 regarding an unsolicited valid non-serious case received from an other health care professional via Medical Information number: 00665242.  This case involves an unknown age and gender baby who was administered an expired dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] by a physician (Expired product administered).  The patient's medical history, medical treatments, vaccinations, concomitant medications and family history were not provided.   On 01-Jul-2021, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE lot number: UJ350AAA, expiry date: 22-JUN-2021 via an unknown route in unknown administration site for prophylactic vaccination.  It was case of an actual medication error due to expired vaccine used (latency: same day).  It was reported "Medical Assistant reports she does not have patient information. She is working from home and the information was also just called in to her. Adverse Event (AE) Reporting AE event: A physician administered an expired Pentacel to a baby. Date of AE: today. Given by: Unknown, Product used".  At the time of reporting, no adverse event was reported.  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.
Positive Covid 19 virus test; Positive Covid 19 virus test; This is a spontaneous report from a contactable consumer (patient) from a program. A 58-year-old female patient received bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 15Mar2021 (Batch/Lot Number: EN6208) as dose 2, single, and via an unspecified route of administration, administered in left arm on 22Feb2021 (Batch/Lot Number: EN6200) as dose 1, single for COVID-19 immunisation (age at vaccination: 58 years old). Medical history included heart transplant on 09Apr2020. The patient's concomitant medications were not reported. The patient tested positive for the COVID-19 virus on 22Apr2021. She was also admitted to the hospital in Apr2021 after testing positive for the COVID-19 virus. That test was the swab in the nose, and it was an awful test. The patient reported they did that test. She was admitted on 22Apr2021 and stayed in the hospital for about 6 days. During this hospitalization, she received the monoclonal antibody infusion. The patient underwent lab tests and procedures which included COVID-19 virus test positive on 22Apr2021. Outcome of the events was unknown.
This spontaneous report was received from an office manager and refers to a 4 year-old patient of unknown gender. There was no information about patient's concomitant medications, concurrent conditions or pertinent medical history reported. On 28-OCT-2016, the patient was vaccinated with the first improperly stored dose of VARIVAX, lot number M027885 with an expiration date on 30-JUN-2018 (dose, route and anatomical location was not reported) for prophylaxis. The vaccine was exposed to temperature of 7.7 Fahrenheit (F) during 24 hours. There was no previous temperature excursion. No adverse effects were reported. No data logger was involved. This is one of several reports from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1704USA004460: US-009507513-1704USA004461: US-009507513-1704USA004462: US-009507513-1704USA004463: US-009507513-1704USA004464: US-009507513-1704USA004465: US-009507513-1704USA004466: US-009507513-1704USA004467: US-009507513-1704USA004468: US-009507513-1704USA004469: US-009507513-1704USA004470: US-009507513-1704USA004471: US-009507513-1704USA004472: US-009507513-1704USA004473: US-009507513-1704USA004475: US-009507513-1704USA004476: US-009507513-1704USA004477: US-009507513-1704USA004478: US-009507513-1704USA004479: US-009507513-1704USA004480: US-009507513-1704USA004481: US-009507513-1704USA004482: US-009507513-1704USA004483: US-009507513-1704USA004484: US-009507513-1704USA004485: US-009507513-1704USA004486: US-009507513-1704USA004487: US-009507513-1704USA004488: US-009507513-1704USA004489: US-009507513-1704USA004490: US-009507513-1704USA004491: US-009507513-1704USA004492: US-009507513-1704USA004493: US-009507513-1704USA004494: US-009507513-1704USA004495: US-009507513-1704USA004496: US-009507513-1704USA004497: US-009507513-1704USA004498: US-009507513-1704USA004499: US-009507513-1704USA004500: US-009507513-1704USA004501: US-009507513-1704USA004502: US-009507513-1704USA004503: US-009507513-1704USA004504: US-009507513-1704USA004505: US-009507513-1704USA004506: US-009507513-1704USA004507: US-009507513-1704USA004508: US-009507513-1704USA004509: US-009507513-1704USA004510: US-009507513-1704USA004511: US-009507513-1704USA004512: US-009507513-1704USA004513: US-009507513-1704USA004514: US-009507513-1704USA004515: US-009507513-1704USA004516: US-009507513-1704USA004517:
fainted shortly after receiving the dose.; Information has been received from a report on social media via the company representative, referring a female patient of unknown age. The patient's medical history, concurrent condition and concomitant medication were unknown.  On an unknown date, the patient was vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (dose, frequency, route, lot# and expiration date were unknown)for prophylaxis.   Shortly after vaccination of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), the patient experienced fainted. The patient sought medical attention. The patient was hospitalized and was prescribed unknown treatment. The outcome of fainted was unknown. The causality between hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) and fainted was unknown.  Upon internal review, fainted was determined to be medically significant.  This case was a non-valid case, as no reporter's identifier was provided.
Client had been vaccinated 12/4/19 with MMR. Minimum interval between live vaccines not met.
COVID-19; loss of taste and smell; loss of taste and smell; This spontaneous case was reported by a consumer and describes the occurrence of ANOSMIA (loss of taste and smell), AGEUSIA (loss of taste and smell) and COVID-19 (COVID-19) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced ANOSMIA (loss of taste and smell) and AGEUSIA (loss of taste and smell). On 05-Apr-2021, the patient experienced COVID-19 (COVID-19). At the time of the report, ANOSMIA (loss of taste and smell), AGEUSIA (loss of taste and smell) and COVID-19 (COVID-19) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Apr-2021, SARS-CoV-2 antibody test: unknown (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by investigator  No treatment medications provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: Follow up received on 27APR2021, updated the additional event COVID-19 positive. On 27-Apr-2021: Follow up received on27APR2021, no new information
This is a spontaneous report from a contactable consumer (patient) reported that a 50-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number was not reported), via an unspecified route of administration, administered in arm right on 02Aug2021 16:30 (at the age of 50-years-old) as dose 1, single for covid-19 immunisation. The vaccine was administered at the Pharmacy/drugstore. The patient medical history included breast cancer (TNBC), asthma, seizures, sinus, allergies, and chronic bronchitis. Concomitant medications included colecalciferol (VIT D [COLECALCIFEROL]); propranolol taken for an unspecified indication, start and stop date were not reported; montelukast sodium (SINGULAIR) taken for an unspecified indication, start and stop date were not reported; and pantoprazole; all were taken for an unspecified indication, start and stop date were not reported. The patient previously took Neosporin, and experienced allergy. On 03Aug2021, throat feels very swollen like allergic reaction, and chills, nausea. No treatment was received for the events. The outcome of the events was not recovered. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Soreness/redness in vaccination site. Headache, body aches, tiredness. Slept all day and still don't feel l need to go back to bed. Lack of appetite.
Elevated temp 105 for almost 24hrs; vomiting, treated w/inc amount of non-aspirin & forced fluids;
headaches shortly after vaccine, diarrhea, nausea, myalgias 3 days later
Right arm painful for 2 days; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Right arm painful for 2 days) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032M20A and 015M20A) for COVID-19 vaccination.     Concurrent medical conditions included Sulfonamide allergy, Blood pressure management, GERD and Cholesterol. Concomitant products included LISINOPRIL from an unknown date to 21-Apr-2021 for Blood pressure, MAGNESIUM for Bone disorder NOS and Muscle disorder NOS, ATORVASTATIN for Cholesterol, PANTOPRAZOLE for GERD, BIOTIN for Hair disorder NOS, Nail disorder NOS and Skin disorder NOS, ACETYLSALICYLIC ACID (ASPIRIN LOW) for Heart disease, unspecified.   On 04-Feb-2021 at 8:15 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021 at 1:30 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Mar-2021 at 3:11 AM, the patient experienced PAIN IN EXTREMITY (Right arm painful for 2 days). On 11-Mar-2021, PAIN IN EXTREMITY (Right arm painful for 2 days) had resolved.            It was reported that the patient experiences a similar reaction from the yearly flu vaccinations.  Treatment medications were unknown. Action taken with mRNA-1273 in response to the events was not applicable.    This case was linked to MOD-2021-034711, MOD-2021-034040 (Patient Link).
began A-Fib as I was most the way home. It remained for more than 30 minutes, but seems to have subsided at this time of typing.