chrisvoncsefalvay/vaers-outcomes huggingface dataset:
got positive COVID-19 test; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (got positive COVID-19 test) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form, second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2022, the patient experienced COVID-19 (got positive COVID-19 test). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) in 2022 for COVID-19, at an unspecified dose and frequency. In 2022, COVID-19 (got positive COVID-19 test) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2022, SARS-CoV-2 test: (Positive) Positive (3 weeks prior) and (Negative) Negative after 7 days treatment with paxlovid.         No concomitant medication was reported. It was reported that, the patient received 2 booster doses months ago and tested positive for COVID-19 three weeks prior to this report. The patient was treated with Paxlovid approximately 2 days after symptoms and was tested negative on day 7 of treatment. Approximately for 5-7 days the patient was week . The patient was fine at the time of this report. Company Comment:    This is an spontaneous case concerning a 70-years-old male patient with no medical history  Reported who experienced the unexpected AESI of COVID-19, unknown days after the 4th. dose of mRNA-1273 vaccine. In 2022, SARS-CoV-2 test Negative after 7 days treatment with paxlovid and was Positive 3 weeks before it. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.  Events seriousness was assessed based on medical judgement   This case was linked to US-MODERNATX, INC.-MOD-2022-636282 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments: Company Comment:    This is an spontaneous case concerning a 70-years-old male patient with no medical history  Reported who experienced the unexpected AESI of COVID-19, unknown days after the 4th. dose of mRNA-1273 vaccine. In 2022, SARS-CoV-2 test Negative after 7 days treatment with paxlovid and was Positive 3 weeks before it. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.  Events seriousness was assessed based on medical judgement US-MODERNATX, INC.-MOD-2022-636282:Reporters wifes case
redness and swelling at injection site; redness and swelling at injection site; muscle pain; muscle and joint pain; not feeling well; This is a spontaneous report from a contactable consumer (patient). This 67-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140) at the 1st dose on 22Dec2020, at the 2nd dose on 12Jan2021; both via an unspecified route of administration at left arm at single dose for covid-19 immunization. Medical history included diabetic and allergies to sulfur drugs. Concomitant medications included other medications in two weeks. The patient was not pregnant. The patient had no other vaccine in four weeks. The patient experienced redness and swelling at injection site, muscle pain, muscle and joint pain, and not feeling well on 24Dec2020. No treatment was received for events. The patient had no COVID prior vaccination. The patient had Covid test post vaccination by Nasal Swab on 11Jan2021 with negative result. Outcome of the events was unknown.
RIGHT ARM. ITCHING AND RASH/SWELLING GREATER THAN SIZE OF HAND. STARTED MIDDAY ON NEXT DAY, PATIENT DID NOT NOTICE SWELLING UNTIL LATER THAT EVENING. HAS NOT YET RESOLVED WITH BENADRYL AND HYDROCORTISONE CREAM.
suspected vaccination failure; has them now; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a male 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 was unknown and the outcome of the shingles was not recovered/not resolved.   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 case was reported by the patient's wife. The age at vaccination was not reported. After receiving Shingles vaccine, the patient got shingles at the time of reporting. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation of shingles were not provided.
Child came into clinic for booster vax on 02/07/2000. On 02/09 she presented to the clinic with right deltoid swollen and hot to touch. Grandparent was concerned and wanted child checked by doctor. Referred for evaluation.
she had a headache at the back of the neck rather than the temple; very, very sore arm; fatigued; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (very, very sore arm), FATIGUE (fatigued) and HEADACHE (she had a headache at the back of the neck rather than the temple) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma. Concomitant products included PREDNISONE for an unknown indication.    On 21-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Sep-2021, the patient experienced PAIN IN EXTREMITY (very, very sore arm) and FATIGUE (fatigued). On 23-Sep-2021, the patient experienced HEADACHE (she had a headache at the back of the neck rather than the temple). On 23-Sep-2021, PAIN IN EXTREMITY (very, very sore arm) and FATIGUE (fatigued) had resolved. On 26-Sep-2021, HEADACHE (she had a headache at the back of the neck rather than the temple) had resolved.            It was reported that patient was placed on a double dose or prednisone.  Treatment information was not specified.   This case was linked to MOD-2021-348439, MOD-2021-348409 (Patient Link).
Tinnitus; Affects my ability to hear; Affects my ability to completely sleep; Affects my ability to concentrate some days; This is a spontaneous report from a contactable reporter (consumer or non-HCP). The reporter is the patient.   A 43-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in right arm, administration date 09Jun2021 at 13:15 (Lot number: EW0183) at the age of 43 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "Penicillin allergy" (unspecified if ongoing), notes: known allergies: Penicillin. Concomitant medication included: LOESTRIN taken for birth control. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot number: EW0169, vaccine location: right arm, administration Time: 13:15), administration date: 12May2021, when the patient was 43 years old, for COVID-19 immunisation.  The following information was reported: TINNITUS (non-serious) with onset 09Jun2021, outcome "not recovered", described as "Tinnitus"; HYPOACUSIS (non-serious) with onset an unknown date in 2021, outcome "not recovered", described as "Affects my ability to hear"; INSOMNIA (non-serious) with onset an unknown date in 2021, outcome "not recovered", described as "Affects my ability to completely sleep"; DISTURBANCE IN ATTENTION (non-serious) with onset an unknown date in 2021, outcome "not recovered", described as "Affects my ability to concentrate some days". The event "Tinnitus" was evaluated at the physician office visit. Therapeutic measures were taken as a result of tinnitus. Additional information: It was also reported that the tinnitus would not go away. The patient could not remember exact day but it was right after second dose. The patient went to doctor, referred to specialist and was waiting till after holidays to go. The patient thought it would go away if the vaccine only lasted 6 months but it was not going away. It affected ability to hear and completely sleep or concentrate some days. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive other vaccines within four weeks prior to COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. The event tinnitus resulted in doctor or other healthcare professional office/clinic visit.
Limping, favoring right leg. Limitation at flexion and rotation of right hip due to pain.
He has been feeling weak.; Initial information received on 28-Oct-2019 regarding an unsolicited valid non-serious case received from a consumer.  This case involves a 65 years old male patient who received a 0.5 ml dose of vaccine INFLUENZA VACCINE TRIVALENT [FLUZONE HIGH DOSE] via intramuscular route on 25-Oct-2019.  The patient's past medical history, medical treatments, vaccinations and family history were not provided.  Information on the batch number was requested.  It was reported on 25-Oct-2019 reporter husband is not feeling too good, since he took the shot He has been feeling weak. Today, he said that he is feeling a little better. But he is a little white again. He is functioning additionally it was reported as On Saturday, he went to the gym and he had to leave because he felt light headed. He had the shot on Friday.  The outcome of the event was recovering.
I asked a fellow MA for some help locating a vaccine and they handed it to me I didn't think to check the expiration because they handed it to me and I though they checked it come to find out they didn't and the person who verified me didn't check the expiration date either because they thought I did.
Light headedness/diziness; Pain in chest; Difficulty breathing; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Light headedness/diziness), CHEST PAIN (Pain in chest) and DYSPNOEA (Difficulty breathing) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0540C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Jun-2021, the patient experienced DIZZINESS (Light headedness/diziness), CHEST PAIN (Pain in chest) and DYSPNOEA (Difficulty breathing). On 18-Jun-2021, DIZZINESS (Light headedness/diziness) had resolved. At the time of the report, CHEST PAIN (Pain in chest) and DYSPNOEA (Difficulty breathing) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided
Pain, swelling, redness at injection site starting a few hours after. Headache and fever starting the next day. All symptoms lasted about a week.
high fever to 105 followed by sz;brought to ER by EMS in post-ictal state;adm to hosp 10OCT96;
Day 7 post shot, pain, itchy red rash, and warmth at injection site and swollen lymph nodes
Runny nose, coughing, mild diarrhea (ate a lot of dried apricots, she thinks was due to that). starting 12/20/21
Estimated delivery date 05/09/2021. I had extreme fatigue and I had some trouble walking it flared my osteoarthritis. I decided to stay home and work from home since I was having trouble walking, the next day I felt fine.
pt was described by mom to have had fever up to 102 R & brief episode of tonic sz last 1min, 12 hrs following vax;
I get a muscle spasm in my right thigh about 4 times a day that lasts for 3 minutes.
arm was not as red as the 1st vaccine; fever; body aches; headache; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 30-Apr-2021 and was forwarded to Moderna on 11-May-2021.    This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (arm was not as red as the 1st vaccine), PYREXIA (fever), MYALGIA (body aches) and HEADACHE (headache) 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 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (arm was not as red as the 1st vaccine), PYREXIA (fever), MYALGIA (body aches) and HEADACHE (headache). At the time of the report, ERYTHEMA (arm was not as red as the 1st vaccine), PYREXIA (fever), MYALGIA (body aches) and HEADACHE (headache) outcome was unknown.            No concomitant medication was reported. No treatment medication was reported. Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to MOD-2021-034445 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 31-May-2021: Follow up document was attached on 31-May-2021 which contains non significant information.
Pt received injection at left deltoid and immediately swelling occurred at the injection site there was about 1-1.5 inches inside. Was later informed red arm became 3-5 inches in size. No dyspnea or sob. Pt had thick oral thrust on toung. Attempt to call the pt the next day and phone was not working at the time .
A report has been received from a Physician concerning, male subject, who had been receiving Nasal FLUMIST QUADRIVALENT. FLUMIST QUADRIVALENT started on 30-Sep-2013. The patient experienced tested positive for Flu (Preferred term: Influenza virus test positive) which started on 13-Jan-2014. The outcome of the event of tested positive for Flu is unknown. The report was considered to be non-serious.
Pt c/o extremely sore arm with mild warmth in the deltoid since day injection was given.  He is on day 5 of pain in that arm, which is longer than what the manufacturer's data suggests is normal.
1640 Post-vaccination while participant was in monitoring area, RN noticed participant?s consent was for a second Moderna shot (0.5 ml). A Moderna booster shot was administered (0.25 ml). team lead RN and RN made aware.  1643 1645 Dr. made aware. Advised to inform patient to obtain Moderna booster in 6 months.   1647 The patient, made aware that a Moderna booster dose of 0.25ml was administered instead of Moderna second dose of 0.5 ml. Per Dr. was educated on getting the Moderna booster in 6 months. verbalized understanding.
Starting approximately 24 hours after vacination, patient experienced fevers ranging from 101-103.5 that have continued for >72 hrs, requiring ibuprofen to reduce fever and fussiness.
This case was reported by a healthcare professional and described the occurrence of viral syndrome in a 8-year-old female subject who was vaccinated with KINRIX (GlaxoSmithKline).  On 28 January 2010 the subject received unspecified dose of KINRIX at 0.5 ml in the right thigh. It was noted to be the 5th dose but series not specified. On 1 February 2010, 4 days after vaccination with KINRIX, the subject experienced viral syndrome, fever (to 102 degrees, ear) and cough. At the time of reporting the outcome of the events was unspecified. It was also noted that the subject's sister was ill at home for approximately 7 days concurrently. Follow-up information received on 02 March 2010 indicated that the outcome of the events was unknown as well as attribution to KINRIX. No additional detail provided.
This spontaneous report as received from a medical assistant refers to a patient of an unknown age and gender. No information regarding the patients' medical history, concurrent conditions and concomitant medications was provided. On 26-JUN-2016, the patient received dose of improperly stored VAQTA with lot# M011116 and expiration date 17-MAY-2017, via intramuscular route (dose was not reported). Administered dose underwent temperature excursions at 31 Fahrenheit degrees, for 10 hours. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information is not expected.
Swelling at injection site. A lump reported to be 6 inches wide and 4 inches tall appeared about 1 hour after injection. Patient did not report pain. Went to an urgent care and was told to apply a warm compress to the injection site.
4/4/22 PMH of COPD, A-fib (not on AC), DVT, TBI, and HTN -- presenting for worsening SOB
Patient stated that he received his second dose Moderna Vaccine on 03/25/2021 in his left arm and on 05/16/2021 he got into the shower in the evening and noticed his right arm (where he received his first moderna vaccine on 02/25/2021) was extremely sore and it hurts right where he got the vaccine and it is a muscle ache feeling and also a joint achy feeling.
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical histories provided. On 28-NOV-2016, the patient was vaccinated with improperly stored dose of VARIVAX injection, subcutaneously, lot # M031970, expiration date 30-JUN-2018 (dose was not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 6.4 degrees Fahrenheit for 24 hours. Data logger was not involved. There were no previous excursions reported. Additional information has been requested.
Thinks COVID-19 Vaccine triggered her lupus; bother her shoulder, but not as bad; Tiredness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 58 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 01Apr2021 Given at afternoon (Lot number: ER8733) at the age of 57 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Subacute Discoid Lupus" (unspecified if ongoing), notes: It is lupus of the skin, not systemic, Diagnosed at least ten years ago. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose: 1, Batch/lot number: EN6199, injected into the left arm), administration date: 11Mar2021, when the patient was 57 years old, for COVID-19 immunization, reaction(s): "Tiredness"; Bnt162b2 (Dose: 1, Batch/lot number: EN6199, injected into the left arm), administration date: 11Mar2021, when the patient was 57 years old, for Covid-19 immunization, reaction(s): "nausea feeling", "The shoulder, where it was given on the left side, it swelled all the way up into her neck", "lymph nodes on that side of the body were inflamed", "It hurt form her shoulder to her elbow"; Measles vaccine (When 4-5 years old), for Measles, reaction(s): "she contracted Measles". The following information was reported: CUTANEOUS LUPUS ERYTHEMATOSUS (medically significant) with onset 2021, outcome "unknown", described as "Thinks COVID-19 Vaccine triggered her lupus"; MUSCULOSKELETAL DISCOMFORT (non-serious) with onset 2021, outcome "unknown", described as "bother her shoulder, but not as bad"; FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "Tiredness". The event "thinks covid-19 vaccine triggered her lupus" was evaluated at the physician office visit.  Reporter is a social worker. She had to go to the doctor because of this specific reason and was instruction by the CDC representative to contact Pfizer for reimbursement. She went right back in and got a second dose COVID-19 Vaccine. Tiredness got her again, but not as bad. Second dose COVID-19 Vaccine did bother her shoulder, but not as bad. The nurse injected the vaccine on the same left arm as the first dose. It did flare up a little, but not nearly as bad as it was with the first dose COVID-19 Vaccine. She didn't have to go back to the doctors. The patient thinks COVID-19 Vaccine triggered her lupus.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200063461 Same patient and drug, different doses and similar events
On 7/23/10 approx 6PM clt stated "very painful" red bump to left arm. Clt denies fever or illness at time, clt did not need to seek med attention according to family. Clt presented to clinic today (7/24/10) with area of 25x20 mm red area, warm to touch and tender, no fever or illness noted today. Clt had full range of motion to (L) arm - Clt presented to seek med attention ASAP if symptoms persist/worsen; family verbalized understanding. Instructed to use cool compress if needed.
Patients was vaccinated at 1130 with Pediatric dose Pfizer. Within 15 minutes, the patient began to be lethargic and one of the nurses gave him a juice box. RN was called to patient and the patient remained lethargic and was laying on his moms lap. He reported that he was very sleepy and his eyes were mostly shut. 1142 MD STAT was called and  The first team arrived at 1146.  At 1152 his HR 84 BP 80/48 and 96 RA. Breath sounds equal and clear, strength equal bilateral. Pediatric MD came and did an assessment and another set of vital was completed. Patient saturation was swinging from 93-96 but hands were cold. We covered patient with sheet to warm up. Patient, while still lethargic reports that he is starting to feel a little better. After sitting the gurney up, the blood pressure read 94/61 HR 89 with a sat of 99. 1214 Blood sugar was 97. The doctor determined that he was improving from his lethargy and assessed his ability to stand up. After standing patient felt better and more active and left at 1231.
Fever, chills, terrible body aches, unrelenting headache, nausea for 14 hours
Systemic: Hyperventilation-Moderate, Additional Details: pt became hyperventilated and was looked to be having a panic attack....no prev hx of allergies or adrs to previous moderna shots...mother was there to give her gatorade and I gave her cold water.....pt would be able to maintain deep respirations to try and calm down but was struggling...after about 10 minutes I told the mother that I was calling ems since she was still having issues...mother agreed and ems came...pt seemed to be fine but ems took her b4 I could f/u