chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Covid test result positive; patient tested positive for COVID-19; Aches; Back ache; All joints hurt; This is a spontaneous report from a contactable consumer. A 77-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EN6207), via an unspecified route of administration on 12Mar2021 at 13:15 in left arm as a single dose for covid-19 immunization. Medical history included atrial fibrillation. The patient did not received any other vaccines in 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Known allergies were reported as none. Concomitant medications included amoxicillin trihydrate, clavulanate potassium 875 mg, lisinopril, apixaban and diltiazem: all start and stop date was not provided and used for unspecified indication. On 13Mar2021 at 12:00, the patient experienced back ache, all joints hurt, aches, fever, sore throat and cough. The patient took tyneol. The adverse events resulted in emergency room/department visit or urgent care. The patient was quarantined for 10 days and Dexamethasone was prescribed. On 19Mar2021, the patient tested positive for COVID-19. The patient underwent lab tests and procedures which included SARS-COV-2 test as positive on 19Mar2021 via nasal swab. The outcome of all events was recovering/resolving.  No follow-up attempts are possible. No further information is expected.
Arm where Tdap was given (and MCV4) became red and swollen after vaccination. It lasted a few days. No hopitalizaton or office visit required.
Client stated on 1/30/21 she started to have pain in her left arm. Pain continued and on 2/2/21 she visited the Emergency Room. At the ER she was given a splint for her left arm and instructed to take ibuprofen. She stated she is feeling better today and her left arm is still a "little weak (2/3/21)..
The pt experienced enlarged armpit glands and the injection site was tender and painful. The next day, the pt experienced lung congestion and cough. Redness at injection site was also experienced and a fever 48 hours later. Treated with Tylenol.
Second shot gave me severe body aches; fatigue; headache; sore arm; swollen lymph node in left armpit; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 26 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 08Jun2021 14:00 (Lot number: EW0182) at the age of 26 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Depression" (unspecified if ongoing); "Anxiety Disorder" (unspecified if ongoing); "ADHD" (unspecified if ongoing); "Penicillin" (unspecified if ongoing). Concomitant medication(s) included: VYVANSE; LEXAPRO; FENOFIBRATE. Past drug history included: Augmentin. Vaccination history included: Bnt162b2 (1st dose, lot number=EW0153, vaccine location=Left arm), administration date: 18May2021, when the patient was 26 years old, for COVID-19 immunization, reaction(s): "Sore arm", "Fatigue". The following information was reported: PAIN (non-serious) with onset 08Jun2021, outcome "recovering", described as "Second shot gave me severe body aches"; FATIGUE (non-serious) with onset 08Jun2021, outcome "recovering", described as "fatigue"; HEADACHE (non-serious) with onset 08Jun2021, outcome "recovering", described as "headache"; PAIN IN EXTREMITY (non-serious) with onset 08Jun2021, outcome "recovering", described as "sore arm"; LYMPHADENOPATHY (non-serious) with onset 08Jun2021, outcome "recovering", described as "swollen lymph node in left armpit". Therapeutic measures were not taken as a result of pain, fatigue, headache, pain in extremity, lymphadenopathy.  Additional information:  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No treatment was received to the response of adverse events. The patient was not diagnosed with COVID-19 prior to vaccination and Since the vaccination, patient was not tested for COVID-19.   No follow-up attempts are possible. No further information is expected.
On the morning of 05/31/22 I had a scratchy throat. I took and at home COVID-19 test but it was negative so I continued going about my business. My throat was worse the next day and I felt a bit stuffy, but I still tested negative and went to work. I took a PCR test and received positive results on 06/02. I then stayed home with fatigue, cough, and fever. By around day 4 I began to notice a bit less fatigue. I was instructed to take an at home test on day 5 but was still positive. After 10 days, my symptoms had subsided and on day 11 I had my first negative result on an antigen test. Overall it just felt like a bad cold or flu.
Staff member was poked by a needle after it fell off the syringe while in the patient's arm resulting in a "dirty needle stick".
11/7/18 - patient reports stiff neck; 11/8/18 - reports she broke out in a rash and still has a stiff neck, rash itches and burns. Also reports having a knee replacement, which is swollen and pink currently. Advise following up with the doctor. Left message with agent at doctor's office.
102.5 fever.  Chest pains,  very uncomfortable.  Bone pain,  joint pain.  Shooting pain in ears and knee.  Sharp stomach pains. Fatigue.
Guillain-Barre ?, was hospitalized in hospital. Received IVIG, steroids. Work-up did not confirm.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 019B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Feb-2021 at 11:26 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 28-Mar-2021 at 11:32 AM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. In 2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 67.46 for dose administered on 28-Feb-2021 and 67.54 for dose administered on 28-Mar-2021.  Concomitant products were not provided. For Batch number 014M20A On 28-Feb-2021, Excursion time were at 09 AM was 27, at 01 PM temperature was 26, total doses given for the day was 152, condition of vaccine prior to vaccination was not frozen, vaccine was moved to fridge on 24-Feb-2021, vial was moved to clinic on 27-Feb-2021. 20 vial was moved to clinic. Vaccine BUD date was 26-Mar-2021. For Batch 019B21A On 28-Mar-2021, Excursion time 10 AM, temperature was 35,  total doses given for the day was 150, condition of vaccine prior to vaccination was not frozen, vaccine was moved to fridge on 23-Mar-2021, vial was moved to clinic on 27-Mar-2021. 15 vial was moved to clinic. Vaccine BUD date was 22-Apr-2021.  It was reported that unknown number of patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34- or 35-degree F. The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. Temperature recordings were taken by using a traceable temperature monitor at every hour. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature. No treatment information was provided
Headache, Myalgia, Arthralgia, Fever, NauseaVomiting,  Arm sore, woke up writhing in pain, joint pain, HA,  nausea, chills  Narrative:
severe rash developed progressively spreading from neck and arms to whole body.  Started on Saturday night April 10th probably 8 hours after vaccination showing a few dimples small enough that we just monitored. Sunday showed more rash and took benadryl 25mg every 6 hours until Monday morning when we saw physician who prescribed medicine to treat the rash. Rash did not improve and spread even more and more pronounced by Tuesday morning at which time we called physician to let her know we would take patient to the hospital. Patient is currently at hospital and is day 3. A physician evaluated her in the er and hours later patient was admitted to the hospital. A specialist was supposed to see mom the next day but never showed up and after complaining and insisting they finally had another specialist see patient this morning (name will have to confirm once I see the nurse in charge this afternoon during visiting hours, but doctor was the name I was given that was on the schedule to see patient the day before)
Information has been received from an office manager concerning an approximately 66 year old female with auto-immune system disorder who on 04-NOV-2010 was vaccinated with one injection of 0.5ml PNEUMOVAX 23. The patient experienced redness and a 'hot' sensation in the right arm at the injection site immediately after receiving the vaccination and both reactions were attended to by physician. At the time of report, the outcome was unknown. This is one of several reports received from the same source. Additional information has been requested.
she developed left knee pain and swelling.; she developed left knee pain and swelling.; This is a spontaneous report from a contactable consumer (patient).  A 69-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration on 11Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 12Apr2021 the patient developed left knee pain and swelling. Outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
This is a spontaneous report from a contactable consumer (patient). A female patient, of an unspecified age, received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# not reported), via an unspecified route of administration, on Sep 4, 2021, single dose, for COVID-19 immunization. The patient's medical history and concomitant medications not reported. On an unspecified date in Sep 2021, patient experienced dizziness, a higher resting heart rate than normal, heavy brain fog and memory loss. Patient wanted to know if these side effects were previously reported. She also asked if she could get the second dose after a reaction with first dose. Lastly, she asked how much was the protection from COVID-19 prevention to being hospitalized; with receiving only the first dose of the vaccine. The outcome of the events unknown. The lot number for the vaccine, BNT162B2, not provided and will be requested during follow-up.
This spontaneous report as received from a Certified Medical Assistant refers to a 5 year old male patient. Concurrent conditions and medical history were not reported. The reporter informed that on 01-AUG-2015, the patient was vaccinated with an expired dose of M-M-R II Injection, 0.5 mL subcutaneously in the right arm, lot # J006185, expiration date 24-MAY-2015. No adverse effects were reported and no Product Quality Complaint (PQC) was involved. Additional information is not expected as the reporter did not wish to be contacted for further follow-up.
Fever 102; Vomiting; Nausea; This is a spontaneous report from a contactable reporter (consumer or other non-HCP). The reporter is the parent.  A 16 year-old male patient received bnt162b2 (BNT162B2), administered in left arm, administration date 08Dec2021 at 11:45 (Lot number: unknown) at the age of 16 years as dose 2, single for COVID-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot Number: Unknown, vaccine location: Left arm, administration time: 11:30), administration date: 17Nov2021, when the patient was 15 years old, for COVID-19 immunisation.  The following information was reported: PYREXIA (non-serious) with onset 08Dec2021, outcome "recovering", described as "Fever 102"; VOMITING (non-serious) with onset 08Dec2021, outcome "recovering", described as "vomiting"; NAUSEA (non-serious) with onset 08Dec2021, outcome "recovering", described as "nausea". Relevant laboratory tests and procedures are available in the appropriate section. It was unknown if therapeutic measures were taken as a result of pyrexia, vomiting and nausea.   Additional Information: The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Since 3rd Anthrax shot, has had ringing/hum sound in left ear (2 years duration). Evaluated by local MD with neg physical findings.
Hot flashes; Fatigued and drained energy; Nauseous; Chills; Fatigued and drained energy; Continuous headache; Dizziness; Feeling out of place and not feeling 100%; Diarrhea and was continuously going to the bathroom; A spontaneous report was received from a 20-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced fatigue, drained energy, nauseous, dizziness, feeling out of place, not feeling 100 percent, diarrhea, headache, hot flashes and chills.   The patient's medical history was not provided. Concomitant medications included unknown birth control.    On 04 Jan 2021, the patient received the first of two planned doses of mRNA-1273 (Lot: 025J20-2A) intramuscularly for prophylaxis of COVID-19 infection.  On 05 Jan 2021, the patient started to experience side effects. She felt a little fatigued, and drained energy and physically wise. During lunch, she felt nauseous and was trying force herself to eat because she had not eaten all day. After lunch she stated she "felt more nausea, fatigue and dizziness, describing it as feeling out of place and not feeling 100 percent. Later that evening she experienced diarrhea. She also experienced hot flashes and chills. She stated that she has a continuous headache and was unsure if it was from not eating, but she drank water and still had it.    On 06 Jan 2021, the patient stated that she still feels the chills, diarrhea and headache. No treatment was provided.   Action taken with mRNA-1273 vaccine was unknown.  The outcome of events, fatigue, drained energy, nauseous and hot flashes, were resolved.   The outcome of events, chills, diarrhea and headache, were ongoing.  Reporter causality for the events was not provided.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Apr-2021 at 11:01 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Apr-2021 at 11:01 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 66.20.  Concomitant medications were not provided.  On 31-Mar-2021, Excursion time was 09 AM, temperature was 32, total doses given for the day was 199, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 30-Mar-2021, vial was moved to clinic on 31-Mar-2021. 14 vials were sent to clinic. Vaccine BUD date was 29-Apr-2021.  Vial was stored on cooler 1, on 31-Mar-2021, Excursion duration At 8 AM: 32, 9 AM: 32, 10 AM: 40, 11 AM: 42, 12 AM: 43, 1PM: 44, 2 PM : 46, 3 PM: 46, 4 PM: 44 and 5 PM : 44.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a Fisherbrand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
Fever x 5 days up to 104. Nausea. Decrease appetite. Neutropenia. Elevated liver function test.
periods of confusion, dizziness, transient tingling of lt fingers on 3NOV95-9NOV95 SOB, dec BP, noc sweats, inc WBC, diarrhea, low grade fever especially since 3NOV95; MD told pt has some type of viral infect-prob secondary to vax
Breast tenderness; Breasts are lumpy and prominent; A little fatigue; This spontaneous case was reported by a consumer and describes the occurrence of BREAST TENDERNESS (Breast tenderness), BREAST MASS (Breasts are lumpy and prominent) and FATIGUE (A little fatigue) in a 42-year-old female patient 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. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Nov-2021, the patient experienced BREAST TENDERNESS (Breast tenderness), BREAST MASS (Breasts are lumpy and prominent) and FATIGUE (A little fatigue). At the time of the report, BREAST TENDERNESS (Breast tenderness), BREAST MASS (Breasts are lumpy and prominent) and FATIGUE (A little fatigue) had not resolved.            No concomitant medications were reported. Treatment medication was not provided by the reporter.  Patient got the Moderna booster and was experiencing side effects. Patient had a little fatigue and breast tenderness, feels like patient was about to breastfeed. Patient's breasts were lumpy and prominent. It started about 3 days after the vaccine and was still happening now. The patient had zero side effects from the first two doses.  This case concerns a 42-year-old, female patient, with no known medical history, who experienced the non-serious, unexpected events of breast tenderness and breast mass and non-serious expected event of fatigue. The events occurred  three days after booster dose of mRNA 1273 vaccine. The patient felt fatigue, breast tenderness, and her breasts felt lumpy and is ongoing as of receipt of report. The rechallenge is not applicable as no additional dose is expected. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a 42-year-old, female patient, with no known medical history, who experienced the non-serious, unexpected events of breast tenderness and breast mass and non-serious expected event of fatigue. The events occurred  three days after booster dose of mRNA 1273 vaccine. The patient felt fatigue, breast tenderness, and her breasts felt lumpy and is ongoing as of receipt of report. The rechallenge is not applicable as no additional dose is expected. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.
Information has been received from a physician concerning a female who on 17-APR-2012 was vaccinated orally with a 2ml dose of ROTATEQ (Lot# not reported). On 28-JUN-2012 the patient experienced intussusceptions. The patient went to hospital to seek for medical attention and was hospitalized. Therapy with ROTATEQ was discontinued. At the time of this report, the patient had not recovered and was still in hospital. Additional information has been requested.
pt recvd MMR vax & 4 wks later devel fever & generalized arthralgia; no further details were provided;
Patient was inadvertently given Menactra instead of the ordered HPV vaccine; Initial information received on 17-Apr-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to case ID 2019SA111884 and 2019SA111891 (same reporter).  This case involves a 15 years old male patient who was inadvertently vaccinated with MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] lot U6151AA, expiry date: 16-Mar-2020, via unknown route in the right arm on 17-Apr-2019 instead of HPV vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  No concomitant medications reported.  It is an actual medication error case due to wrong vaccine administered. It was reported that patient had received the Menactra at 11 years for routine vaccination and at 15 years the patient was inadvertently given Menactra instead of HPV vaccine.  It was not reported whether the patient experienced any adverse event or not.  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 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.  List of documents held by sender: none.
developed severe pain in the left mid foot, plantar aspect for  36 hours,  it moved to the right foot for 48 hours, and then returned  to the left foot heel and  metatarsal area.   All this started within  36 hours  of injection.    It is still present  but  tolerable.