chrisvoncsefalvay/vaers-outcomes huggingface dataset:
She got her vaccine, immediately began to feel tired and exhausted. The injection going into her arm was really painful, so her arm is still sore and painful, and she is sore underneath her armpit and down along her side underneath her breast a little bit. She spiked a really temp of 104, and she has been extremely weak, unsteady on her feet, very low appetite and tries to stay hydrated. She does feel a little bit better today and still feels weak and exhausted. She is a fairly active person, does not get sick and cannot tell when she had her lost cold, and really a healthy person. She also has headache, nausea, high fever which has been difficult to keep under control. She has used Tylenol along with cold cloths all over her head, neck, chest, wrists. She is not having a fever at this time, but she has had shakes and feeling of just quivering mostly from weakness. She would start burning out and then pop out with soaking sweats to where she had to change her clothes 2-3 times a day due to it. That has abated at this time, and today when she woke up she felt like maybe she had passed the worst of it. She was too weak to get to the bathroom on her own, which has never happened. She had similar reaction with the third vaccine, but also had the flu vaccine at that time as well, and assumed it was due to those two.  She now realizes that this reaction was similar, but this one was worse.
I thought I was getting my first cold in three years. I was a bit achy but I had been working out so I thought it may be that, I did not have a fever. I was meeting some friends for brunch and since I had been travelling, I thought I better test with home COVID-19 test. It did come back positive. I called my doctor and had a virtual visit with my doctor, she prescribed PAXLOVID. I am feeling better now, I just have a lingering cough.
This spontaneous report as received from a consumer, refers to herself, a 79-year-old at the time of the report (also reported as 82-year-old) female patient with unspecified thyroid disorder (reported as "thyroid"). No historical conditions, drug reactions or allergies were reported. The patient was not pregnant. On an unknown date, the patient was vaccinated with a 0.5 ml dose of PNEUMOVAX 23, subcutaneously (lot# reported as M013756, expiration date: October 2017, strength was not reported). Concomitant therapies included unspecified diuretic. As the patient was taking PNEUMOVAX 23, on an unknown date, she experienced a swollen red arm, that was painful for a few days. She sought medication and went the see the pharmacist. No treatment was given for the adverse events. There were no lab diagnostics studies performed. The patient recovered from the events on an unspecified date. No product quality complaint was involved. Causality between swollen red arm, that was painful and PNEUMOVAX 23 was not reported. Lot # M013756 is an invalid lot number for PNEUMOVAX 23. Additional information has been requested.
within 4 hours and 20 minutes of receiving the Pfizer vaccine I had a rash on my Right forearm that last approximately 3 hours and then disappeared.  My throat was itchy for six days (I have No other allergies other than the medication Levaquin which was disclosed at the time of the vaccine.  I was assured ingredients from Levaquin are not in the vaccine).  That evening at approximately 9:30 my tongue swelled slightly and stayed that way for four days
swollen rash that itches/ swollen; swollen rash that itches; swollen rash that itches; Hard under the skin; 4x4 cm and warm snfbit itches.; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 25-May-2021 and was forwarded to Moderna on 25-May-2021.    Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (swollen rash that itches/ swollen), RASH (swollen rash that itches), PRURITUS (swollen rash that itches), INDURATION (Hard under the skin) and SKIN WARM (4x4 cm and warm snfbit itches.) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 16-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SWELLING (swollen rash that itches/ swollen), RASH (swollen rash that itches), PRURITUS (swollen rash that itches), INDURATION (Hard under the skin) and SKIN WARM (4x4 cm and warm snfbit itches.). At the time of the report, SWELLING (swollen rash that itches/ swollen), RASH (swollen rash that itches), PRURITUS (swollen rash that itches), INDURATION (Hard under the skin) and SKIN WARM (4x4 cm and warm snfbit itches.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  Treatment information was not provided
Pt recvd vax 10JUN92 & devel drainage & a lump @ the inject site;
Dizziness; Head pressure; Every time I stand up I have uncoordinated movement with dizziness; vertigo; sore throat; Getting waves of anxiety out of nowhere; headaches; Body soreness; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DIZZINESS (Dizziness), HEAD DISCOMFORT (Head pressure), COORDINATION ABNORMAL (Every time I stand up I have uncoordinated movement with dizziness), VERTIGO (vertigo) and OROPHARYNGEAL PAIN (sore throat) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Dizziness), HEAD DISCOMFORT (Head pressure), COORDINATION ABNORMAL (Every time I stand up I have uncoordinated movement with dizziness), VERTIGO (vertigo), OROPHARYNGEAL PAIN (sore throat), ANXIETY (Getting waves of anxiety out of nowhere), HEADACHE (headaches) and MYALGIA (Body soreness). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. At the time of the report, DIZZINESS (Dizziness), HEAD DISCOMFORT (Head pressure) and COORDINATION ABNORMAL (Every time I stand up I have uncoordinated movement with dizziness) had not resolved and VERTIGO (vertigo), OROPHARYNGEAL PAIN (sore throat), ANXIETY (Getting waves of anxiety out of nowhere), HEADACHE (headaches) and MYALGIA (Body soreness) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: normal (normal) Normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.    Most recent FOLLOW-UP information incorporated above includes: On 12-Jun-2021: Follow-up information received on 12-JUN-2021, added address, lab test, treatment medications and additional events (dizziness, head discomfort, co-ordination abnormal).
A non-serious spontaneous report of influenza has been received from a healthcare professional concerning a six-year-old female, subsequent to receiving FLUMIST. The patient's past medical history included being a twin and concomitant medications included varicella vaccination two days prior to FLUMIST. The patient received FLUMIST on 22-Oct-2010. After receipt of FLUMIST the patient developed influenza. PCR was positive for influenza. The outcome of the event was not reported.
Received the first dose of Moderna 7 days ago. This evening  my arm started to itch and I noticed it was swollen at the injection site. Feels like a bump under my skin. Red circle around the area.
Patient's reaction(s) noted during COVID vaccine observation period: lips tingling like when he eats shellfish; has shellfish allergy  Actions Taken: Vital signs taken and within normal. Pt felt okay enough to go home.  Disposition: Patient declined ED visit
This is a spontaneous report from a consumer reporting for herself. A 69-year-old female patient received PREVNAR 13 via an unspecified route of administration at single dose injection in left arm in Jan2017 or Feb2017 for immunization, for compromised immune system (it would give more protection), at doctor's office. Medical history included ongoing diabetes mellitus diagnosed about 10-15 years before, ongoing asthma diagnosed about 10-15 years before, ongoing bronchiectasis diagnosed about 10-15 years before, ongoing osteoporosis diagnosed about 10-15 years before, ongoing nerve injury diagnosed about 10-15 years before, ongoing sleep apnoea syndrome diagnosed about 10-15 years before, allergic to a lot of medications diagnosed about 10-15 years before, compromised immune system. She has been told those preexisting conditions will never go away. The patient's concomitant medications were not reported. She has had a pneumonia vaccine before, but this was her first PREVNAR 13 shot. She had another pneumonia shot years before, but this was the first time she got side effects. One week after her shot, she has been to a whole bunch of doctors and no one knows why, she is hoarse. She has a compromised immune system and it did not do anything for the system, she got laryngitis and it came and went and came and went. She has had laryngitis for 3 months now. States she has been to a whole bunch of doctor's and don't know why she is hoarse. She had a CAT scan and pulmonary function tests (PFT) about a month before. They were normal other than what was already there from the bronchiolectasis and asthma. The shot did not do anything for her body, she did not even get a flu shot because of her compromised immune system. The PREVNAR didn't do anything. They gave her the shot, then she had to go back within a month because her doctor did bloodwork to see if there were antibodies and there was nothing. This is a permanent stop of PREVNAR 13. Since she was allergic to a lot of medications, so she could be allergic to something in it. The outcome of the events was reported as: not recovered laryngitis/laryngitis worsened,  not recovered for hoarse, unknown  for doesn't do anything for her body/gave her the shot then she had to go back within a month because her doctor did bloodwork to see if there were antibodies and there was nothing, unknown for could be allergic to something in it. A Product Complaint was filed. The sample of the product was not available to be returned.
Shingles; unilateral facial swelling, pain, tingling, numbness, rash.
rash; This is a spontaneous report from a contactable other hcp via a Pfizer sponsored program. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported.  The patient experienced rash in both arms lasted 24 hrs after first dose of vaccine. Outcome was unknown.   Information on the lot/batch number has been requested.
Neck felt stiff; Red, itchy rashes all the way across her neck, face, forehead and upper chest/Rash on arm, neck, and chest; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Neck felt stiff) and RASH (Red, itchy rashes all the way across her neck, face, forehead and upper chest/Rash on arm, neck, and chest) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 001B21A) for COVID-19 vaccination.     Previously administered products included for an unreported indication: SHINGRIX on 19-Jan-2021.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (Neck felt stiff) and RASH (Red, itchy rashes all the way across her neck, face, forehead and upper chest/Rash on arm, neck, and chest). On 22-Feb-2021, MUSCULOSKELETAL STIFFNESS (Neck felt stiff) outcome was unknown. At the time of the report, RASH (Red, itchy rashes all the way across her neck, face, forehead and upper chest/Rash on arm, neck, and chest) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-098966 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: Lot number, Treatment meds
administered Moderna Covid-19 vaccines beyond the 30 day use by date to 20 patients; administered Moderna Covid-19 vaccines beyond the 30 day use by date to 20 patients; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered Moderna Covid-19 vaccines beyond the 30 day use by date to 20 patients) and PRODUCT STORAGE ERROR (administered Moderna Covid-19 vaccines beyond the 30 day use by date to 20 patients) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045L21A, 020F21A and 007M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Aug-2021 at 9:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Feb-2022 at 8:59 AM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 25-Feb-2022 at 8:59 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered Moderna Covid-19 vaccines beyond the 30 day use by date to 20 patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (administered Moderna Covid-19 vaccines beyond the 30 day use by date to 20 patients). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered Moderna Covid-19 vaccines beyond the 30 day use by date to 20 patients) and PRODUCT STORAGE ERROR (administered Moderna Covid-19 vaccines beyond the 30 day use by date to 20 patients) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported Date the vial was initially stored in the refrigerator: 19Jan2022. The vail did not undergo any temperature excursions. No treatment medications were reported     This case was linked to MOD-2022-503845 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 04-Mar-2022: Follow-up received contained non-significant information
Pt. was extremely irritable, fever to 104, & was "jerking/twitching" 10 hrs. following imm. Pt. seen in this office 4-28-05. Jerking/twitching has stopped but still continues with fever, (102.4 in office)
Arm got red, swollen, very sore sad hot to the touch on day 9.   It is about 3 inches x 6 inches about 2 fingers below the injection site
This patient received their second Pfizer COVID-19 vaccine on 6/4/2021.  The patient began experiencing arm pain which migrated to his chest on 6/6/2021.  The pain resolved but returned with increased severity on 6/7/2021, prompting medical evaluation.  The pain was described as a pressure sensation in the center of the chest and in bilateral arms.  Upon initial evaluation, he was found to have an abnormal EKG with ST segment changes.  Troponin was significantly elevated.  He was transferred to the hospital.  A transthoracic echo was obtained and was normal.  He was hospitalized on the pediatric cardiology service, admitted on 6/8/2021.  Troponin trended down during his stay. He was started on lisinopril.  He was discharged home on 6/9/2021 with plan for outpatient pediatric cardiology follow up.  Given the proximity of his second Pfizer COVID-19 vaccine to onset of his symptoms, and given similar reported events, the chief concern is whether his episode of myocarditis is related to administration of the Pfizer COVID-19 vaccine.  I was on call as attending physician when this patient was admitted.  Physician cared for this patient as the pediatric cardiology inpatient attending during his hospital course.
Adverse event: Morning of 11/27/2019 the patient woke up with chest pain , difficulty in breathing , urine retention , headache, fever 38C , vision problem, difficulty walking,  disoriented , not being able to swallow water and vomiting after the first trial.  Treatment : call 911 , transfer to hospital ( first to  ER then to ICU ), MRI , lumber puncture , biopsy from the brain then dated 12/17/2019 , the result was inconclusive therefore the patient  was  transfered to surgical intensive care for higher care .
Initial unsolicited report received from a nurse practitioner on 30 September 2016. This case is linked to 2016SA181982. (Same vaccine, same reporter). This case involves a patient (age and gender not reported) who was vaccinated with a dose of FLUZONE QIV (Batch number: UI658AA, expiry date: 30-Jun-2017 and batch number: UI657AB expiration date: 30-Jun-2017, dose, dose series, route and site of administration were not reported) on an unspecified date. It was reported that "the reporter did not have the number of patients who received which lot number". Patient's medical history and concomitant medications were not reported. On an unspecified date, following the vaccination patient experienced upper arm redness, swelling, itching, rash, tenderness of vaccinated arm, generalized body aches, headache, neck pain, upset stomach, sore throat, fatigue and also experienced dizziness and couldn't lift the arm ("but did not know if patient was unable to move arm due to discomfort from moving arm or it was due to weakness or inability to move arm. Lab data and corrective treatment were not reported. The outcome of the events was reported as unknown. List of documents held by sender: none.
Patient first came back to pharmacy counter and said he didn't feel good, looked like he lost color in his face so had him sit down immediately. Then said he had a ringing in his right ear. Then said he couldn't move his fingers, looked stiff, then said the ringing is going away, but his feet are going numb. Can't move his feet, then said his face hurt, but feet were getting better. Then started to breathe heavier, which is when EMT arrived.
High fever 102 for 2 days then slowly decreased. All over body aches. Nausea. Extremely dizzy. Weak.
tested positive for COVID virus; tested positive for COVID virus; This is a spontaneous report from a contactable consumer reporting on behalf of the patient via a Pfizer Sponsored Program. A female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, unknown lot number and expiration), via an unspecified route of administration on 25Jan2021 at a single dose for COVID immunization.  The patient's medical history and concomitant medications were not reported. It was reported that the patient received first dose of COVID vaccine on 25Jan2021, just after that, the patient tested positive for COVID virus on unspecified date in 2021. The patient's caregiver also tested positive, the caregiver has been quarantined and has been symptom free. The patient was in hospital for observation while having COVID. The reporter is wondering if the patient or caregiver (not sure if the caregiver received the first dose of COVID vaccine; pending clarification) is able to get the second dose of vaccine. The outcome of the events was unknown.   Information on the lot/batch number has been requested.
No adverse event, other than patient is shy by approximately 2 months from 18th birthday. Emergency use authorization indicated for 18 years old and older
Arm pain, described as "collapsible  pain" and weakness, persisting through 6/24/2021.  Client called PCP office and was told it was an "injection issue".  Client has not sought further medical care for concerns.  Returned for 2nd vaccine to same location  received Moderna in right arm  Experienced similar symptoms in right arm with pain extending in arm to back of neck.
On about 6/6/2022, I developed a terrible headache, which Tylenol and ibuprofen couldn't help. I was also very fatigued and nauseous. I didn't vomit, but I was really nauseous. The only thing that helped the headache was occasionally pressing my head very hard into a pillow. I didn't have any respiratory symptoms, though. I took a home antigen test on 6/6/2022, and the result was negative. When I took another test on 6/7/2022, the result was positive.  On 6/8/2022, I began to get a fever in the evening. It was on that day that I also was prescribed Paxlovid, which I began taking the same day. The Paxlovid left such a horrible taste in my mouth that I woke up in the middle of the night. I continued taking it, though, and I began feeling better the next day. The headache had most especially improved, and the fever was gone. By 6/10/2022, I was pretty much over the symptoms, though I continued to have the foul taste that was caused by the medication.
Tonic Seizure, drooling, unresponsive, headache.  Treatment: Tylenol 1000 mg, Dilantin 300 mg.
Severe deltoid muscle pain within a few minutes of the injection, bleeding with "blood running down the arm".  Pain continued through the day with gradual improvement but did not go away.  That night (about 17 hours later) pain at injection site was severe and fever of 102.  Comment: This report is being submitted 23 hours after the injection, I am the patient's father and a physician. I suspect accidental injection into an arteriole within the deltoid muscle.
Pt reports within 4 1/2 hours after vaccine administered in her R deltoid, she felt pain in her R knee. She reports the pain "jumped" around from R leg to R shoulder to R wrist and hand. Reports could not sleep but by next morning-no pain. Denied arm swelling/edema.
This spontaneous report was received from a pharmacist, and refers to a 37 year old female patient. No information about the patient's medical history, concurrent conditions and drug reaction allergies was provided. On 06-MAR-2018, the patient was vaccinated with the first dose of VARIVAX, for prophylaxis, (dose, frequency, route, lot number and expiration date were not provided). The vaccine was reconstituted with sterile diluent (manufacturer unknown). Since an unknown date in 2018, the patient reported being "sick" (malaise), as the patient was scheduled for the second dose of VARIVAX 28 day after the first dose, however, the patient reported being sick. It was reported that the patient sought medical attention by contacting the reporter's pharmacy, nevertheless, it was unknown if a treatment was prescribed to the patient. At the time of reporting, the outcome of malaise was unknown. The causal relationship between VARIVAX and malaise was not provided.