chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Received 4 doses of the Moderna COVID 19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXTRA DOSE ADMINISTERED (Received 4 doses of the Moderna COVID 19 vaccine) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced EXTRA DOSE ADMINISTERED (Received 4 doses of the Moderna COVID 19 vaccine). At the time of the report, EXTRA DOSE ADMINISTERED (Received 4 doses of the Moderna COVID 19 vaccine) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 was not applicable. Concomitant and treatment medication was not provided.; Reporter's Comments: This report refers to a case of extra dose administered for mRNA-1273 with no associated AEs.
Numbness in left leg; This spontaneous case was reported by a pharmacist and describes the occurrence of HYPOAESTHESIA (Numbness in left leg) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPOAESTHESIA (Numbness in left leg). At the time of the report, HYPOAESTHESIA (Numbness in left leg) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported. No Treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 10-Sep-2021: Follow-up contains Reporter's Email address Updated.
That evening the child became congested and had a fever. Continued to have worsening "cold" symptoms, but fever stopped. 4 days later fever of 99.3 returned and continues to have thich nasal discharge. These same symptoms happened after the 2 and 4 month shots also. The Dr. said it was coincidence after the first 2 times. This is the 3rd time and mom is worried.
Ongoing headache, moderate sinus pressure and congestion, drowsiness; took an Advil Sinus Congestion & Pain tablet (200mg ibuprofen, 10mg phenylephrine HCI)
2d after vaccine area became red, indurated and itchy. No warmth or tenderness.
This spontaneous report as received from a registered pharmacist refers to a patient of unknown age. The patient was vaccinated with a dose of ZOSTAVAX (Lot # not reported) in the left arm on 06-SEP-2012. No other co-suspects were reported. No concomitant medications were reported. The pharmacist reported that on an unknown date, the patient experienced redness, soreness and warmth at the injection site. After 2 days, the symptoms were improved and no treatment was required. The pharmacist stated that the patient did not receive any vaccination on 06-SEP-2012 other than ZOSTAVAX. Additional information has been requested.
Patient states she started to experience pain, most often in the arm and hand of the injection (left) starting about 5 days after administration. She described the pain as an aching nerve pain, usually from the elbow down to the hand, She states she also experiences pain that moves to the legs and other arms, as well as fatigue, weakness and pain to the touch in the wrist of the left arm.
Severe vertigo 3 days after vaccines. positional, generalized unable to stand. PE normal.
Day after vaccination, my rheumatoid arthritis came back, full blown, intense joint pain, swelling, fatigue. My T cells didn?t like your vaccine. Am now on a two week prednisone burst to see if I can come back out of it.
Per client report; went to local ER at 6:30pm with "big splotchy areas on skin and felt like throat was closing up" states was given steroid shot and Benadryl.
Headache, back pain 8 days after vaccine  Shortness of breath, burning in chest, extreme fatigue, back pain, intermittent headache  on days 9-13 after vaccine Temperature 100.0 on day 11 after vaccine  COVID tests on days 9, 10, and 13 all negative
The pt received the varicella vaccine on 2/1/01. One week later developed hives on wrist, arms and back. Resolved after a couple of days. No further complaints.
Burning sensation all over her skin; Very tired; This is a spontaneous report from a contactable consumer (patient). A 76-years-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, batch no: EN6205, NDC number; expiration date: unknown), via unspecified route in the deltoid left on 26Feb2021 at 15:00 as single dose for COVID-19 immunization. The patient medical history included blood pressure. Concomitant medication included atenolol taken for blood pressure as 25 mg, amlodipine as 2.5 mg and doxazosin as 1 mg, both taken for blood pressure measurement. Patient previously had first dose of BNT162b2 (Lot: EL9264, NDC; expiration date: unknown) on 05Feb2021 for COVID-19 immunization. On 27Feb2021, in the morning when she woke up, she had burning sensation all over her skin. She rested all day on the 27Feb2021 and then Sunday 28Feb2021 she was just a little tired but there was no more of the burning sensation. She confirmed the tiredness started on Saturday 27Feb2021. She usually works on Saturday, but she could not work because she was too tired. By Sunday 28Feb2021 she was better. She thought she rested and continued to rest because she was still a little tired. She recovered by Monday and she went back to work. The patient did not receive any treatment for the events. The clinical outcome for the event burning sensation was recovered on 28Feb2021 and very tired was recovered on 01Mar2021.  No follow-up attempts are possible. No further information is expected.
Admitted on 7/21 with shortness of breath. Placed on Vapotherm in the ED and found bilateral confluent nodular consolidative pulmonary opacities on CT scan. Had a positive home COVID test on 7/18. Started on decadron and doxycycline and sent to critical care. Started remdesivir. ID was consulted and started on ceftaroline and zyvox due to concerns of superimposed bacterial infection with MRSA. On 7/24 family decided to make patient DNR. Switched from zyvox to daptomycin then to oxacillin also. Weaned patient down to 3L via nasal cannula. On 7/26 patient pulled our NG tube partially and aspirated. Desatted and required BiPAP and place on levophed for BP support. Family decided to move to comfort care.
itchiness; rashes on both arms and Palms; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchiness) and RASH (rashes on both arms and Palms) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hypothyroidism. Concomitant products included LEVOTHYROXINE for an unknown indication.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Feb-2021, the patient experienced RASH (rashes on both arms and Palms). On an unknown date, the patient experienced PRURITUS (itchiness). At the time of the report, PRURITUS (itchiness) had not resolved and RASH (rashes on both arms and Palms) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Severe fever (over 103F), severe headache, sore in muscle, pain in joint,
Parasthesia/weakness in left side of face 24 hours after each shot, lasting for ~8 hours. Approximately 1 month after 2nd shot, parasthesia returned in face and left arm/leg. Constant muscle twitching in left knee. Hyperosmia. Chest/neck tightness. Left jaw pain.
one patient was administered a dose of expired ROTATEQ; This spontaneous report was received from a registered nurse referring to a 6 months old female patient. Information about pertinent medical history, drug reaction/allergy and concomitant medication was not provided.       On 23-OCT-2020, the patient was administered a dose of expired rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # S000961, expiration date 19-OCT-2020; strength, vaccine dosage detail and route of administration were not reported) for prophylaxis (expired product administered).
Very deep muscle pain, that kind of comes and goes; Joint pain, it's like just deep and very achy as opposed to like any kind of shooting pain; Joint pain, it's like just deep and very achy as opposed to like any kind of shooting pain; This is a spontaneous report from a contactable consumer, reporting for herself.  A 71-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 20Jan2021 (at the age of 71 years old) as a single dose for COVID-19 vaccination. Medical history was not reported. Concomitant medications were not reported, but she was taking other medications.  On 23Jan2021, the patient experienced very deep muscle pain, that kind of comes and goes. On an unspecified date in Jan2021, the patient experienced joint pain, it's like just deep and very achy as opposed to like any kind of shooting pain. The patient received treatment for the events, which included ice pack, Tiger Balm, and ibuprofen 600mg . The clinical outcome of muscle pain was not recovered, and for joint pain and ache was unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
minimum recommended age for COVID19(Pfizer-BioNTech) is 12 11years 9months at date of vaccination  Has been requested to enter all COVID vaccines into system. The teams responsible for screening and administering vaccines to the refugees at the Vaccine site were/are all on duty staff. Staff is assisting with entering information into database and VAERS.
Poor sleep progressing to severe chills, shivers, and tachycardia > 100 BPM.
No adverse affects; Improperly stored MMR II was administered; This spontaneous report was received from a pharmacy technician refers to a patient of unknown age and gender. Patient's medical history, concomitant therapies and concurrent conditions were not reported. On 14-AUG-2019, the patient was vaccinated with improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (dose, strength, frequency were not reported) (lot # R027063 and expiry date 20-SEP-2020) via subcutaneous route for prophylaxis (Product storage error). The vaccine experienced a temperature excursion at 70 Fahrenheit (F) with a time frame of 4 days. There was no previous temperature excursion. It was reported that this call was due to a data logger. No adverse effects were reported  Furthermore, no product quality complaint (PQC) was involved.
INCREASED ERYTHEMA (CELLULITIS) INCREASED WARMTH AND FIRMNESS AND STREAKING MARKS TOWARDS LEFT AXILLARY.  ALSO ENLARGEMENT OF LEFT AXILLARY LYMPH NODES WITH TENDERNESS.
accidentally administered an expired menactra vaccine with no adverse event; Initial information received on 01-Mar-2022 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 59 years old female patient who accidentally administered an expired Menactra vaccine with no adverse event while receiving Meningococcal A-C-Y-W135 (D CONJ) Vaccine [Menactra].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Sodium Chloride.  On 28-Feb-2022, the patient received 0.5mL dose of suspect Meningococcal A-C-Y-W135 (D CONJ) vaccine solution for injection once (Strength, route, lot number: unknown) (expiry date: 31-Jan-2022) in an unknown administration site for immunization.  On 28-Feb-2022, the patient accidentally administered an expired Menactra vaccine with no adverse event (expired product administered) (latency: 1 day) following the administration of Meningococcal A-C-Y-W135 (D CONJ) Vaccine.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event expired product administered.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. 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.
Morning of 04-1-09 : "Restussness" Morning of 4-2-09: Hives
seizure like movements; passed out; dizzy; nausea; This is a spontaneous report from a non-contactable healthcare professional (HCP). A 19-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE)  via an unspecified route of administration on an unspecified date (age at vaccination: 19 years old) (Batch/Lot Number: ew0167) as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. The patient experienced dizzy, nausea, passed out, seizure like movements on an unspecified date. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Redness and swelling at the injection site, not warm or painful.  Increased over the next 24h
This spontaneous report was received from a physician referring to 19-month-old patient of unknown gender. No information regarding the patient's pertinent medical history,concomitant medications and drug reactions or allergies was provided. On 25-APR-2017, the patient was vaccinated with an improperly stored dose of VAQTA (lot # N005274 and expiration date 03-APR-2018; dose and route of administration were not reported) for prophylaxis. It was reported, that on several dates between 24-APR-2017 until 07-SEP-2017, the vaccine was exposed to various temperature excursions ranging from 32 degrees Fahrenheit (F) to 54F for the period of up to 70 hours at a time. Data logger was not involved. No adverse effects were reported. There was no product quality complaint involved. This is one case from several cases from the same reporter.; Sender's Comments: US-009507513-1709USA007325:
itching; rash on arm/ long rash- not uncomfortable for many days/ not at site of shot; This spontaneous case was reported by a nurse and describes the occurrence of PRURITUS (itching) and RASH (rash on arm/ long rash- not uncomfortable for many days/ not at site of shot) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     Concurrent medical conditions included Anxiety. Concomitant products included LORAZEPAM (ATIVAN) for Anxiety.    On 05-Mar-2021 at 1:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021 at 10:00 AM, the patient experienced RASH (rash on arm/ long rash- not uncomfortable for many days/ not at site of shot). On 18-Mar-2021, the patient experienced PRURITUS (itching). On 20-Mar-2021, PRURITUS (itching) and RASH (rash on arm/ long rash- not uncomfortable for many days/ not at site of shot) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.   This case was linked to MOD-2021-146376 (Patient Link).
FLUARIX VACCINE GIVEN TO STUDENT WITHOUT PARENT CONSENT. PARENT NOTIFIED VIA TELEPHONE BY SCHOOL NURSE. FATHER REPORTS NO HX OF PROBLEMS WITH VACCINES.
2 small areas 1/3-1/2 inch diameter of red & rough skin noted;
She woke up in the morning, passed out and lost consciousness briefly, eyes rolling in head and limbs stiff and rigid
Pt received vax /win 12 hrs of vax had breathing problems that lasted a couple of hrs.  Flu like symptoms lasted several days. Condition resolved. 2nd dose 18Jun90 had cough 12 hrs later & breathing problems chest pain. Recoverd.
experienced a site reaction; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE ERYTHEMA (experienced a site reaction) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. ASKU) for COVID-19 prophylaxis.     Question:Describe relevant medical history/conditions, allergy, concomitant diseases and risk factor.Answer:Unknown.     On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (experienced a site reaction). At the time of the report, VACCINATION SITE ERYTHEMA (experienced a site reaction) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant and treatment medications were not reported.  Patient stated with very first dose of Moderna COVID-19 when it recently came out, patient experienced a site reaction, patient had a red arm for a day or 2, but with additional Moderna booster doses (not specified dates) patient did not experience any other side effects. Patient wanted to know was patient eligible to get Spikevax after reaction to the 1st dose of Moderna.   Reporter did not allow further contact
Case completed primary Covid vaccine in February 2021, then was hospitalized and died of Covid in September 2021. Hospitalized at:  Hospital.  Initially hospitalized for Covid pneumonia for 4 days. Treated with Dexamethasone and remdesivir, and discharged home. Readmitted 5 days later with worsening hypoxia, kidney injury and pneumonia. Also treated with tocilizumab, yet respiratory condition worsened, and case died.
Moderna COVID-19 Vaccine EUA NO ADVERSE EVENT at this time  Patient received full dose of 0.5ml instead of booster dose of 0.25ml
Mother called about 45 minutes, post vax, stating child was sneezing, complaining of stomachache and face swelling. Advised mom to take to ER for evaluation. Checked with mom later into the day and she stated child was given IV medications and a shot. Stated that he was fine at that point (14:00 same day). Advised to not take shots again at follow-up visit.
Symptoms include nonproductive cough- loss of smell- sinus congestion- nasal congestion- post nasal drainage- itchy eyes. starting 11/7/21
pt recv vax; devel urticaria triggered by Hep B vax;to dermatologist;pred,claritin prescribed;
Pt developed a rash and fever of 105. Ibuprofen was ineffective. Lymph glands were swollen, she had a poor appetite for 3 days. 6-8 wet diapers per day.
Warmness; Itchiness at injection site; Redness at injection; Injection site was hurting; red dot showed up; Nervous; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (red dot showed up), NERVOUSNESS (Nervous), FEELING HOT (Warmness), VACCINATION SITE PRURITUS (Itchiness at injection site) and VACCINATION SITE ERYTHEMA (Redness at injection) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced RASH MACULAR (red dot showed up) and NERVOUSNESS (Nervous). On an unknown date, the patient experienced FEELING HOT (Warmness), VACCINATION SITE PRURITUS (Itchiness at injection site), VACCINATION SITE ERYTHEMA (Redness at injection) and VACCINATION SITE PAIN (Injection site was hurting). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency; CLINDAMYCIN at an unspecified dose and frequency; ACETAMINOPHEN at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. On 01-Apr-2021, RASH MACULAR (red dot showed up) had resolved. At the time of the report, NERVOUSNESS (Nervous), FEELING HOT (Warmness), VACCINATION SITE PRURITUS (Itchiness at injection site), VACCINATION SITE ERYTHEMA (Redness at injection) and VACCINATION SITE PAIN (Injection site was hurting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication taken by the patient included thyroid medicines, blood pressure pills. Treatment activities for event was done with  Sulphur based medication, cold pack,  cold compress and some antibiotics .   This case was linked to MOD-2021-074928 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 13-Apr-2021: Follow up information was received and concomitant medication, new event , treatment medications were updated.
pt was accidentally administered tetramune in place of PPD;subsequently pt devel edema & erythema @ the inj site;
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with ZOSTAVAX, lot # N016185 expiration date on 31-JUL-2018, intramuscularly. No adverse effects were reported. Product quality complaint was not involved. Follow up information was received on 25-OCT-2017 from a pharmacist referring to a 68 years old female patient. The patient's medical history, concurrent conditions, drug allergies and concomitant medications were not reported. On 06-AUG-2017 the patient was vaccinated with ZOSTAVAX dose 1 (lot # N021171, Expiry date was not reported) (previously reported as lot # N016185 expiration date on 31-JUL-2018) intramuscular for prophylaxis (incorrect route of drug administration). Patient characteristics, product therapy details, event onset date and narrative updated.
dizziness; This is a spontaneous report from a non-contactable physician (patient's wife). This physician reported similar events for two patients. This is the first of two reports. A 64-year-old male patient received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 20Jan2021 at a single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported. On 01Feb2021, the patient experienced dizziness (non-serious) starting in the morning. The clinical outcome of the event, dizziness, was not recovered.  No follow-up attempts are possible; information about batch/lot number cannot be obtained. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021173289 same drug/reporter/event and different patient