chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Hair loss; Alopecia areata; Dose 1 - 01-APR-2021: Dose 2 - 18-MAY-2021 (> di  42days); This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18May2021 at 12:00 as dose, 2 single (Batch/Lot number: unknown) at the age of 33 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, lot unknown, administration time: 12:00 PM), administration date: 01Apr2021, when the patient was 32-year-old, for COVID-19 immunization. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 18May2021, outcome "unknown", described as "Dose 1 - 01-APR-2021: Dose 2 - 18-MAY-2021 (> di  42days)"; ALOPECIA AREATA (non-serious) with onset 08Jun2021, outcome "not recovered"; ALOPECIA (non-serious) with onset 08Jun2021, outcome "not recovered", described as "Hair loss". The events "hair loss" and "alopecia areata" required physician office visit. Therapeutic measures were not taken as a result of alopecia, alopecia areata.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
On 10/16 I received the flu shot from  a coworker. I am an RN and getting the flu shot is mandatory for all of us. When she injected the vaccine I looked over at my shoulder because it was more painful than usual and I was also surprised at how high up on my arm it was.  Within 30 minutes of receiving the injection I was experiencing abnormal sensations in my 4th and fifth fingers on my L hand and the sensation that my wrist watch was cutting off my circulation although I could (in actuality) slip a finger between the band and my skin. My shoulder had a deep ache within it and I had deep pain at the injection site. I reported this to my supervisor and was seen by, PA, the Associate Medical Director. She agreed the symptoms were concerning and asked me to update her. That night the abnormal sensations resolved but the joint pain worsened and by the morning I could barely move it above my head. I texted PA and she recommended I see my PCP. I made an appointment with my PCP for next available (Monday  10/20) but I cancelled it because it felt like I had the pain under control and didn't want to miss work. Over the next few days I took Motrin in high amounts, used hot packs and ice packs. This continued through the next week. This same week I began having a spastic cough, severe pain in my ribs and abdominals as well as difficulty catching my breath or taking a deep breath. I ended up in urgent care due to this issue on  10/25.   I stopped taking Motrin and the pain  in my shoulder came back, but even worse during the evening on 10/27. The pain woke me from my sleep . I made an appointment with my PCP and went to see Dr. for both my shoulder pain and the respiratory issue on 10/29.  Dr. put me on a burst of oral steroids from  10/30 - 11/3 for the shortness of breath/coughing. During this time, I also experienced complete respite from the shoulder pain and enjoyed my full range of motion and strength for the first time since the vaccine was given. She also sent a referral for me to see an orthopedist.   I saw Dr., (an orthopedist) on  11/15. At the time of our appointment I was not in pain because I was actually back on steroids (11/12-11/16) for continued respiratory symptoms.  He opted to not give me a cortisone injection because of the oral steroids I was receiving. He prescribed physical therapy to me and told me to come back when I was off the oral steroids if PT did not resolve the issue.  My PCP diagnosed me with SIRVA. (Shoulder Injury Related to Vaccine Administration).  I have been in PT since 11/18. I am still symptomatic except for when I am on oral steroids.  I have an MRI scheduled for 12/29 and a corticosteroid injection  scheduled for 1/2/20.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 37-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Apr2021 as dose 1, single (Batch/Lot number: unknown) at the age of 36 years for covid-19 immunisation. The patient's relevant medical history included: "Hodgkin Lymphoma cancer survivor" (unspecified if ongoing), notes: Hodgkin Lymphoma cancer survivor. Concomitant medication(s) included: FISH OIL. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 18May2022, outcome "unknown", COVID-19 (medically significant) with onset 18May2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (26May2022) Negative, notes: at-home antigen test was negative on day 8; (27May2022) Positive, notes: Day 9, symptoms began to return and began to test positive again; (18May2022) Positive, notes: Tested PCR positive for COVID. Treatment start date was 18May2022 and Treatment stop date was 22May2022. COVID vaccine details: Vaccine administration date: 02Apr2021. Vaccine lot unknown reason: Not available/provided to reporter at the time of report completion. Other medication in 2weeks brand: Fish Oil. Adverse event: Paxlovid rebound experience. Tested PCR positive for COVID on 18May2022. Began full course of Paxlovid on 18May2022. Completed full course of Paxlovid on 22May2022. Symptoms subsided and at-home antigen test was negative on day 8. Day 9, symptoms began to return and began to test positive again. By day 11 (time of filing) returned to same symptoms experienced on Day 1. Other medical history: Hodgkin Lymphoma cancer survivor. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for (BNT162N2) has been requested and will be submitted if and when received.
Developed mild chills the evening of the day of vaccination. Chills, body aches, inability to concentrate, and fever up to 100.2 persisted through the next day but were gone on the morning of the second day after the day of vaccination.
This spontaneous report as received from a nurse refers to an unspecified patients of unknown age and unknown gender. On an unknown date, the patients were vaccinated with a dose of an improperly stored PNEUMOMVAX 23 (dose, frequency and lot# were not reported). No adverse effects were reported. No product quality complaint (PQC) was reported for PNEUMOVAX 23. This is one of the several reports from the same reporter. Additional information has been requested.
This is a spontaneous report received from a contactable reporter (consumer or other non-HCP). The reporter is the patient. A 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Dec2021 at 18:00 as dose 3 (booster), single (lot number: FF8841) at the age of 50 years, administered in the left arm for COVID-19 immunization; Covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (lot number: unknown) and as dose 2, single (lot number: unknown) for COVID-19 immunization. The patient's relevant medical history included: "Mild hypertension" (unspecified if ongoing); "Known allergies: Adhesive tape" (unspecified if ongoing); "Vitamin D deficiency" (unspecified if ongoing), notes: blood level was 17; "Blood pressure" (unspecified if ongoing). Concomitant medications included: LISINOPRIL taken for blood pressure management; ESTRADIOL; VITAMIN D3. Other medication in two weeks also included "Rugby 1,000 unit." The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 22May2022 at 19:00, outcome "recovering" and all described as "Tested positive for COVID-19." The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) negative, notes: Rebound infection after negative Covid test; (21May2022) positive, notes: Tested positive 5 days after treatment end with return of less severe symptoms. Therapeutic measures were not taken as a result of Drug ineffective, Covid-19. No follow-up attempts are possible. No further information is expected.
Patient developed diffused hives(2-3) in bilateral lower arms within 15 minutes of injection. Non itching and no other symptoms. Gave 50mg po Benadryl per protocol and patient discharged home without any urgent complications. Patient is stable.
CHRONIC HYPOXEMIC RESPIRATORY FAILURE 12/15/2022  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Fever to 103 24 hours after the immunization febrile seizure lasting 5 minutes at that time and again in 30 minutes. Treated with antipyretics. No current sequelae or symptoms at this time
PATIENT HAD NOT TAKEN HIS BLOOD PRESSURE MEDICATION.  AFTER THE INJECTION HE WAS WAITING FOR 10 MINUTES BEFORE HE SAID HIS HEART WAS RACING. CHECKED BLOOD PRESSURE 130/108 HR 83. FILLED MEDICATION ON FILE FOR PATIENT. HAD HIM REST AND RECHECKED IN 10 MINUTES 134/100 HR 85 . PATIENT WAITED AN ADDITIONAL 10 MINUTES SAID HE WAS FEELING BETTER AND WANTED TO LEAVE
Day 2 - muscle aches and swelling at injection site.  Day 3 & 4 - rash on front and back of torso.
feel their body is unwell; feels a lot of pain; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (feel their body is unwell) and PAIN (feels a lot of pain) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Apr-2021, the patient experienced MALAISE (feel their body is unwell) and PAIN (feels a lot of pain). At the time of the report, MALAISE (feel their body is unwell) and PAIN (feels a lot of pain) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
This spontaneous report as received from a health care worker refers to a 16 years old male patient with no pertinent medical history, drug reactions or allergies. The patient was vaccinated intramuscularly with a 0.5 ml dose of GARDASIL (lot # not reported) on 06-AUG-2012. No other co-suspects were reported. There were no concomitant medications. On 07-AUG-2012 the patient developed red rashes on his arms and abdomen after having GARDASIL administered. The patient sought medical attention by contacting physician and was given treatment with BENADRYL and prednisolone (manufacturer unknown). No lab diagnostic tests were performed. The outcome of red rashes on his arms an abdomen was unknown. The relatedness for the reported event was not provided for GARDASIL. Additional information has been requested.
patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 53-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. Concomitant medication was not provided. Treatment information was not provided.
Gave vaccine on 4/20/22 and later discovered the nurse had not noticed the Beyond Use Date on the box was 4/11. So, we notified pt to return for a revaccination.  Pt has not suffered any ill effects.
client complained of tingling sensation to left arm after receiving 1st Pizer Covid Vaccine. Client had completed 15 min observation when he informed EMT he was feeling tingling sensation to left arm, upper arm, not radiating. Client asked to stay longer in observation. First vitals at 1336: blood pressure 120/78, pulse 66, oxygen 97%. Alert and oriented, no other complaints. At 1344 PHN  arrived, reassessed client.  Alert and oriented. Per client only upper arm tingling sensation, left arm is where he received vaccine. Tingling not worsening or radiating anywhere else. Arm motor and sensory intact. Vitals at 1347: blood pressure 132/76, pulse 83, oxygen 98%.  Per client tingling improving. Wanted to go home. ER precautions given. Client left facility at 1350 with steady gait
Pt recvd HIB vax & 2 months following vax it was noted that pt had devel small nodule @ inject site; nodule described as a small, nontender palpable lesion about size of rice or a small olive;
Two days after flu shot, pt noticed redness/inflammation/scabbing on corners of right shoulder and on forearm. Still present.
Approximately 30 seconds after injection of covid vaccine patient stopped talking, her eyes rolled back and she slumped over in chair. Patients head rolled side to side and patients mom started freaking out thinking she was having a seizure. She screamed at the technician who administered the vaccine to call 911 .  Patient regained consciousness after 10 seconds and was fully alert and able to speak/ answer questions. Pt maintained consciousness the whole time while waiting for the ambulance.  Pt's mom still wanted an ambulance so one was called and EMT's came and accessed the patients vitals. Vitals were all within normal limits and EMTs spoke with mom and advised that pt most likely did not have a seizure and gave the option to transport to the hospital or monitor at home. Mom chose to monitor at home and pt was able to walk out of the store on her own.
ADMINISTERING EXPIRED SOLUTION TO 2 PATIENTS.; This spontaneous report received from a pharmacist concerned multiple patients. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 10-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced administering expired solution to 2 subjects.. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administering expired solution to 2 patients. was not reported. This report was non-serious.
Client received a Moderna booster dose (0.25 ml) instead of Moderna 2nd dose (0.5 ml) on 12/16/2021.  Client was made aware, was vaccinated with Moderna 0.25 ml dose on 12/17/2021.  No adverse symptoms reported in observation period for either dose on either day.
Soreness where the shot was given; A lump where the shot was given; Muscle aches; Fatigue.
A report was received from a health professional on 10/30/2001, concerning an 80 year old female patient experienced an overdose, after inadvertently receiving 2 doses of the Fluvirin vaccine 19 days apart. On 10/30/2001, the patient experienced an overdose after inadvertently receiving a second Fluvirin vaccination 19 days after the first vaccination on 10/11/2001. No adverse effects were reported at time of report. No other information was available. There was insufficient information to determine the causality assessment  of the reporter.
Swollen arm at injection site, red rash in the shape of a circle approximately 2inches in diameter at injection site
not yet received second dose; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 79-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included chemotherapy (gone through chemo back then). Previously administered products included Shingrix (1st dose received intramuscularly on 27th April 2018).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided are as follows: The case was reported by patient for himself. The age at vaccination was not applicable for this report. Till the time of reporting, the patient never went back to get the second dose, which led to incomplete course of vaccination. The patient called to inquired that what to do about the 2nd dose of Shingrix. The reporter consented to follow-up.
Initial information received on 01-Oct-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case is linked to case 2018SA274330 (same reporter). This case involves a female patient (age was not reported) who received a 0.5 mL dose of FLUBLOK QIV (lot number, expiry date, dose in series and site of administration was not reported) via intramuscular route on an unknown date. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. It was a case of actual medication error due to incorrect product storage. It was reported that vaccine had been over a total of 24 hours out of range, too warm (excursion). No known adverse reaction, symptoms were 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 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.
This spontaneous report as received from a registered nurse refers to a 21 year old female patient. No information regarding the patient's medical history or concurrent conditions was provided. On an unknown date, the 21 year old patient was vaccinated with a dose of PROQUAD (Merck) injection  (strength, dose, route of administration, lot # and expiry date were not reported). There were no concomitant therapies reported. No adverse effect was reported. There was no product quality complaint (PQC) involved. Additional information has been requested.
DID NOT KNOW ABOUT THIS UNTIL RECENTLY AS DAUGHTER WAS REFUSING ANY FURTHER VACCINES FOR HER MOM. INFORMATION WAS NEVER RELAYED TO INFECTION PREVENTIONIST TO SUBMIT THE VAERS FORM.  DETAILS: 7/2/2021, SENT TO ER AT 0950. DIAPHORETIC, WEAK, COOL AND EYES ROLLING BACK IN HER HEAD. VSS AND CBG WNL AT TIME. BEGAN VOMITTING UPON EMT ARRIVAL. DTR ACCOMPANIED TO HOSPITAL AND MULTIPLE TESTS WERE RUN. SHE RECEIVED IV FLUIDS , IV ZOFRAN AND PEPCID AT HOSPITAL. SHE RETURNED TO FACILITY AT 1715 ON 7/2/21 WITH NO ACUTE FINDINGS. AND ALL NEGATIVE TEST RESULTS. RETURNED TO BASELINE WITHIN A FEW DAYS.
Muscle ache; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Muscle ache) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, the patient experienced MYALGIA (Muscle ache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, MYALGIA (Muscle ache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported
Fatigue and extreme crappiness for 3 dang days. Lots of rest. Finally got better.
11/27/21 presents to EC ED for "AMS, tachypnea". PMHx of " IVDU, CKD4, COPD, HF"
The Moderna vaccine was inadvertently given too early. It was given at 21 days.
Patient is a 49 y.o. female who received the Pfizer-BioNtech Covid-19 Vaccine, mRNA, BNT162b2 (PF) 30 mcg/0.3 mL IM Susp, Lot EN6208 on 3/11/2021. The patient experienced the following reaction(s) during the immediate of observation: 4:48pm Patient c/o dizziness during observation period. Patient states she is a prediabetic and hasn't eaten since noon. Gatorade given to patient. Patient walked to treatment area. Patient was treated/managed as follows:    4:52pm VS: BP 130/86, HR 90, RR 18, O2 sat 97% on room air. Patient reports feeling better. 5:02pm VS BP 140/80, HR 87, RR 18, O2 sat 98% on room air. Patient states reports symptoms improving. 5:08pm Patient escorted to car by nurse. Patient given educational material regarding vaccine and advised to continue to self-monitor per the CDC guidance.
Breakthrough COVID case after booster delivered in October 2021. Symptoms occurred 1/6/2022, PRC test confirmed positive on 1/8/22. Severe sinus headache and pressure, severe fatigue, low-grade fever and chills (for 3 days), coughing. By 1/10, down to headache and fatigue, some coughing. By 1/21, mostly gone. Sinus headache and fatigue came roaring back on 1/25.
dry cough; cold; fever; second dose was rescheduled outside the window; Contracted COVID; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Contracted COVID), COUGH (dry cough), NASOPHARYNGITIS (cold), PYREXIA (fever) and OFF LABEL USE (second dose was rescheduled outside the window) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Contracted COVID). On an unknown date, the patient experienced COUGH (dry cough), NASOPHARYNGITIS (cold), PYREXIA (fever) and OFF LABEL USE (second dose was rescheduled outside the window). At the time of the report, SARS-COV-2 TEST POSITIVE (Contracted COVID), COUGH (dry cough), NASOPHARYNGITIS (cold) and PYREXIA (fever) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Acute onset of chest pain.  Seen in ER : ECG with mild diffuse ST elevation, elevated Troponin-I  ( >2) PICU admission: supportive care with ibuprofen nd aspirin. Normal cardiac function on echo, normal NT-proBNP. Troponin-I peaked at 2.240, after 1 day Troponin trend downwards. Chest pain resolved.   COVID-19 PCR not detected, Myocarditis panel/viral Ab titers sent- pending,  RSV/flu- NEGATIVE.  Discharged home on ibuprofen with outpatient follow up.
Pt recvd vax 22JUN93; pain rt neck area; blister again shingles on rt neck area;