chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A 15-year-old male presented to the COVID vaccine clinic for a COVID vaccine booster (3rd Dose).  The patient had received two previous COVID-19 Pfizer-BioTNtech 12yrs-adult vaccines on 5/12/21 and 6/2/21. The accompanying parent asked that the patient receive a Moderna booster.  When the nurse checked the reference materials, she erroneously referenced the 18-49 years Pfizer reference materials instead of the 12-17 year reference materials.  The 18-49 years reference allows for a Moderna booster with an initial Pfizer primary series; the 12-17 year reference does not. The patient erroneously received a COVID-19 mRNA LNP-S, PF (MODERNA),50 MCG/0.25 mL booster.  The Pediatrician was notified.  The patient experienced no untoward reaction.
It didn't look like it has 0.5ml in it; This spontaneous case was reported by a consumer and describes the occurrence of INCORRECT DOSE ADMINISTERED (It didn't look like it has 0.5ml in it) 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INCORRECT DOSE ADMINISTERED (It didn't look like it has 0.5ml in it). At the time of the report, INCORRECT DOSE ADMINISTERED (It didn't look like it has 0.5ml in it) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.  Company Comment:  This report refers to a case of incorrect dose administered for mRNA-1273,  with no associated AEs.   Most recent FOLLOW-UP information incorporated above includes: On 17-May-2021: Follow-up information received on 17-05-2021 contains non-significant information. On 25-Jun-2021: Follow up information was received from initial reporter: The reporter declined for further follow up; Sender's Comments: This report refers to a case of incorrect dose administered for mRNA-1273,  with no associated AEs.
10:20 flu vaccine administered. 10:35 color pale c/o lightheaded and tired, slurred speech, HR 72, R 20, BP 128/32, VS normal stable. 10:40 c/o feeling like having hang over, vision blurred. 11:00am notified. Transferred from Dr office via car driven by co-worker, refused  EMS, hospital 2 miles away no distress noted at transfer. 12:20 returned from doctor with orders to go home and sleep. Color normal, weakness and slurred speech remain. Instructed to go to ER if symptoms worsen or remain. 11/11/05 Follow up with patient after reaction following Fluzone injection yesterday. She states that she is feeling much better and has spoken with her physician this morning and was advised to stay home from work and drink plenty of fluids. She is currently experiencing a sore throat and thinks she may have had a  fever accompanied by chills during the night. Headache and muscle aches are present at this time. She was asked if she had ever had a similar experience and she said these same symptoms had occurred five years ago after her last flu shot. She stated that two weeks ago she had a gastrointestinal virus (vomiting and diarrhea) for 4 days. Advised patient not to take a flu sot in the future without consulting a physician about her reaction to the vaccines received five years ago and this year.
after expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (after expiration date) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (after expiration date). On 28-Oct-2021, EXPIRED PRODUCT ADMINISTERED (after expiration date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided. It was reported that numerous patients have received doses of the Moderna covid-19 vaccine after the published expiration date between 28-Oct-2021 and 14-Dec-2021.   Most recent FOLLOW-UP information incorporated above includes: On 16-Dec-2021: Added information in I narrative On 20-Dec-2021: Significant information received. Product start date and dose number  was given.
The patient developed ileocolic intussusception.  The patient was treated with contrast enema and completely reduced by 6/19/2001.
Approximately 60 hours after receiving the first dose of the Moderna vaccine, I developed hives and pruritis in approximately 6 different locations in the area around the injection site (injection site was the left deltoid),  on the left side of my neck, and across the left side of my anterior chest wall.  The hives/pruritis presented near the injection site at approximately 1900 hours on 1/14/21 and spread to the other affected areas within approximately 30 minutes.  At the peak of  it's presence, I would rank the intensity of the pruritis 7 on a 1-10 scale. I took 50mg of Benadryl and 20mg of Pepcid prior to going to bed and when I woke up the following morning, the pruritis had almost completely resolved.  As I type this report, I would rank it a 1 on a 1-10 scale.  The hives resolved over night with the exception of the two original hives that I noticed first last night when symptoms first presented.
Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Abdominal Pain-Medium, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Medium, Systemic: Shakiness-Mild, Systemic: Tachycardia-Mild, Systemic: Vomiting-Medium, Additional Details: 5-6 minutes after receiving her Moderna dose (1st dose for patient), she started displaying signs of an allergic reaction. It was not clear if she was in full-blown respiratory distress, but her breathing seemed more labored and she seemed more and more lightheaded, so 1 dose of EpiPen 0.3 mg was administered. Potential respiratory distress immediately improved upon EpiPen being administered, but then the primary symptom became Nausea and Vomiting.
Feel like you have covid; This spontaneous case was reported by a consumer and describes the occurrence of SUSPECTED COVID-19 (Feel like you have covid) in a  patient of an unknown age and gender 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SUSPECTED COVID-19 (Feel like you have covid). At the time of the report, SUSPECTED COVID-19 (Feel like you have covid) 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.
Subjective fever and decrease activity level at night time. Patient other continue to have good oral intake and not in acute distress on follow up encounter.
I had given patient vaccine with out rechecking to see if he needed it. I will take precautions before giving vaccines.
NUMBNESS AND RADIATING PAIN (RIGHT ARM) AFTER SECOND DOSE, NUMBNESS AND TINGLING AROUND LIPS, NUMBNESS ON RIGHT SIDE OF TONGUE, FOGGY BRAIN, CHRONIC FATIGUE. THESE SYMPTOMS ARE STILL ONGOING.
@. 5 PM light headed, headache, ears clogged, nose stuffed up. @5:10 PM throat stated to feel a little thicker and I took an Allegra 24 he tablet (had taken an Allegra 24 he 24 hrs previously) @9 PM CHILLS and body aches (Took ibuprofen and went to bed)
Fever 101, chills, sore throat, headache, until 11/19/2010 early AM
Rebound infection with new positive testing, fever and symptoms two days after finishing paxlovid; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Rebound infection with new positive testing, fever and symptoms two days after finishing paxlovid) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Asthma, Hypothyroidism, Anxiety and Drug allergy (unknown drug). Concomitant products included LEVOTHYROXINE, FLUOXETINE, BUDESONIDE (PULMICORT) and ALBUTEROL [SALBUTAMOL] for an unknown indication.    On 30-Mar-2022 at 1:00 PM, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Rebound infection with new positive testing, fever and symptoms two days after finishing paxlovid). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 12-May-2022 to 17-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Rebound infection with new positive testing, fever and symptoms two days after finishing paxlovid) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2022, SARS-CoV-2 test: positive (Positive) Positive.         The patient used Paxlovid for treatment of COVID-19. On 20-MAY-2022, the patient had rebound infection with new positive testing, fever. The symptoms returned two days after finishing Paxlovid.  Company Comment: This is a spontaneous case concerning a 52-year-old female patient with no relevant medical history, who experienced the unexpected, non-serious adverse event of special interest of COVID-19, approximately one and a half month after receiving a dose of mRNA-1273 vaccine. The patient was treated with Nirmatrelvir/Ritonavir for 5 days. 2 days after treatment, the patient had fever, symptoms and tested positive. The event had not resolved at the time of the report. It should be noted that the dose was received as fourth dose however, there were no information regarding the previous 3 doses of COVID-19 vaccine. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 52-year-old female patient with no relevant medical history, who experienced the unexpected, non-serious adverse event of special interest of COVID-19, approximately one and a half month after receiving a dose of mRNA-1273 vaccine. The patient was treated with Nirmatrelvir/Ritonavir for 5 days. 2 days after treatment, the patient had fever, symptoms and tested positive. The event had not resolved at the time of the report. It should be noted that the dose was received as fourth dose however, there were no information regarding the previous 3 doses of COVID-19 vaccine. The benefit-risk relationship of mRNA-1273 is not affected by this report.
(L) arm erythema, swelling, induration tenderness and hot to touch on day 2. Erythema: 13cm x 12cm, Fever 101.2, circumference: 17.5cm (L) (R) 15cm.
This spontaneous report was received from a physician via company representatives, referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 15-APR-2015, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB (Lot No. J007946; expiration date 24-MAR-2016), "TF 5mcg/0.5mL Te" (route of administration and anatomical location were not reported). On an unspecified dates, the RECOMBIVAX HB had four temperature excursions: 48 hours (Lowest recorded temperature was 0 F (0 Celsius); 24 hours (Lowest recorded temperature was -1 F (-1 Celsius); 48 hours (Lowest recorded temperature was 1 F (1 Celsius) and 72 hours (Highest recorded temperature was 9 F (9 Celsius). No adverse effects reported. The vaccine status was reported as "in excursion". The vaccine storage criteria and the storage type of excursion were reported as "Refrigerator(R)". No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
received a 30 mcg dose of the Pfizer COVID-19 vaccine (adult formulation-purple cap) instead of the recommended dose of 10 mcg from the orange cap; They had a vaccination error, instead of administering Pfizer kids for 11 year old they have administered Pfizer vaccines for 12; has a slight fever; This is a spontaneous report received from a contactable reporter (Pharmacist) from medical information team for a Pfizer sponsored program.  A 10-year-old female patient received bnt162b2 (BNT162B2, solution for injection), intramuscular, administered in deltoid left, administration date 13Dec2021 (Lot number: 33030BD, Expiration Date: 30Dec2021) at the age of 10 years as dose number unknown, 30 ug single for covid-19 immunization. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PYREXIA (non-serious) with onset Dec2021, outcome "unknown", described as "has a slight fever"; ACCIDENTAL OVERDOSE (non-serious) with onset 13Dec2021, outcome "unknown", described as "received a 30 mcg dose of the Pfizer COVID-19 vaccine (adult formulation-purple cap) instead of the recommended dose of 10 mcg from the orange cap"; PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (non-serious) with onset 13Dec2021, outcome "unknown", described as "They had a vaccination error, instead of administering Pfizer kids for 11 year old they have administered Pfizer vaccines for 12".  Additional information: A 10-year-old female patient inadvertently received a 30-mcg dose of the Pfizer COVID-19 vaccine (adult formulation-purple cap) on 13Dec2021 between like 3:15 and 3:20 like around that time in afternoon instead of the recommended dose of 10 mcg from the orange cap. NDC number of COVID-19 Vaccine: 59267-1000-01. The patient did not receive any prior vaccinations within 4 weeks of covid vaccine.  Follow-up attempts are completed. No further information is expected
ADMINISTRATION OF EXPIRED VACCINE; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, expiry: 21-SEP-2021) dose was not reported, administered on 23-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the patient experienced administration of expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of expired vaccine was not reported. This report was non-serious.
Intense headache, fevers, chills, nightsweats, fatigue, ocular movement pain, and injection site pain with immobility, sx lasting 2 days. Fatigue and intense headache, mild chills persisting on day 4.
A few minutes after her vaccine the patient became dizzy, clammy, and nauseous. She said she felt she might pass out so we got out a yoga mat and cushion for her head so she could lie down. We took her blood pressure which was 102/71 with a pulse of 65. We elevated her legs and gave her a cold pack for her neck and wrists. After watching her for about 30 minutes she felt better and left with her mother.
Really tired; stomach bubbling; This is a spontaneous report from a contactable consumer (patient) via COVAES. A 49-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in right arm, on 10Apr2021 at 01:15 PM (Batch/Lot number was unknown) (at the age of 49 years old) as dose 2, single for COVID-19 immunisation. Medical history included chronic pelvic pain and other unspecified medical conditions. The patient has no known allergies. The patient was taking unspecified medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was really tired and experienced stomach bubbling on 29May2021. The events resulted to physician office visit. The patient did not receive treatment for the events. The patient underwent lab tests and procedures on 20Apr2020 which included a negative nasal swab result. The patient did not recover from the events on the time of the report.  The lot number for BNT162B2 was not provided and will be requested during follow-up.
The patient arrived on 2/24/2021 for a second dose appointment for the COVID-19 vaccine.  She presented a letter.  The letter detailed an experience from Dose 1 on 1/22/2021.  The Patient reports she sat at  Nurse Station 2 at the clinic.  The patient noted that the syringe was uncapped while sitting on the table.  Nurse dismissed her concern and told her she had just uncapped the syringe. That syringe was used to inject the patient.   The patient suffered absolutely no side effects and became suspicious that she had not actually received the vaccine.  She consulted her PCP who ran antibody lab work on 2/15 and 2/22.  These were all negative.  Her PCP is also concerned that she may have been injected with a used syringe. Her PCP is ordering the HIV and Hepatitis labwork. The patient would like to receive another dose to ensure that she completes a 2 dose series.
Redness, swelling at injection site, cranky. Episodes of diarrhea. Treatment of Benadryl, warm moist packs, Tylenol as needed.
she had been administering PROQUAD to an unspecified number of patients aged 12 years through 18 years of age since an unspecified date; she had been administering PROQUAD to an unspecified number of patients aged 12 years through 18 years of age since an unspecified date; No adverse effects; This spontaneous report has been received from a nurse via a company representative referring to an unspecified number of adolescent patients. The patients' concurrent conditions, medical history, concomitant medications, drug reactions/allergies were not reported.  The nurse reported she had been administering  measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (dose, route, lot# and expiration date were not reported) to the patients since an unspecified date (product administered to patient of inappropriate age and product use in unapproved population). No adverse effects were reported.  This is one of two cases from the same reporter.; Sender's Comments:  US-51294589-1908USA001356:
Headache, mayalgia, weakness; improving; recent onset (6/17/15) metallic taste; similar symptoms with first vaccine, lasting 2 days.
MMRV given SQ. After administration informed of juvenile arthritis - takes methotrexate 10 mg sq q 7 days.
This case was reported by a other health professional via sales rep and described the occurrence of shingles in a 72-year-old female patient who received SHINGRIX (batch number 539A2, expiry date 30th March 2020). Concomitant products included methotrexate. On 22nd March 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 24th March 2018, 2 days after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left arm. Shingles appeared on the patient's face, neck and back.
Information has been received from a 65 year old female with " stomach problems", a penicillin allergy and a "sulfa" allergy who on 22, Feb 2006 was vaccinated SC with a 0.5 ml first and second dose of hepatitis B virus vaccine rHBsAg (yeast) (Lots #'s 651363/0336R and 646145/0624N) Concomitant therapy included "Chinese herbal supplement." It was reported that lot # 646145/0624N expired on 09, Feb 2006. Subsequently on 22, Feb 2006 the patient developed pruritis at the injection site. Medical attention was not sought. There were no laboratory diagnostic tests performed. At the time of the report the patient had not yet recovered. There was no product quality complaint involved. Follow up information was received from the consumer indicating that she wanted to know if she could sue her physician due to the administration of the expired vaccine. Additional information is not expected.
This spontaneous report as received from a pharmacist refers to a 80 years old female patient with no pertinent medical history or drug reactions/allergies. The patient was vaccinated with, 0.65 ml ZOSTAVAX (lot #: 672676/0069AE) on 06-AUG-2012. There was no concomitant medication. On 09-AUG-2012 the patient developed injection site rash. The pharmacist said it looked like a mosquito bite. The patient came to Pharmacy to seek medical attention and did not receive treatment. The outcome of injection site rash was reported as not recovered/not resolved. The relatedness for injection site rash is unknown for ZOSTAVAX. Additional information has been requested.
On May 7,  about a week after my second dose, I began  spotting. I spotted for 5 days. I usually have very normal periods. I have never experienced this before. My period is now 13 days late. I am not pregnant and there is no chance that I would be.
passed out on the floor; sweat; discomfort; Head is in discomfort; neck is in discomfort; very nauseous; sore at the site; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (passed out on the floor), HYPERHIDROSIS (sweat), DISCOMFORT (discomfort), HEAD DISCOMFORT (Head is in discomfort) and MUSCULOSKELETAL DISCOMFORT (neck is in discomfort) in a 63-year-old female 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.  Concomitant products included MAGNESIUM and COLECALCIFEROL, MENAQUINONE (D3 +K2) for an unknown indication.   On 26-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-May-2021, the patient experienced LOSS OF CONSCIOUSNESS (passed out on the floor), HYPERHIDROSIS (sweat), DISCOMFORT (discomfort), HEAD DISCOMFORT (Head is in discomfort) and MUSCULOSKELETAL DISCOMFORT (neck is in discomfort). On an unknown date, the patient experienced NAUSEA (very nauseous) and VACCINATION SITE PAIN (sore at the site). On 02-Jun-2021, HYPERHIDROSIS (sweat), DISCOMFORT (discomfort), HEAD DISCOMFORT (Head is in discomfort) and MUSCULOSKELETAL DISCOMFORT (neck is in discomfort) had resolved. At the time of the report, LOSS OF CONSCIOUSNESS (passed out on the floor), NAUSEA (very nauseous) and VACCINATION SITE PAIN (sore at the site) had resolved.            The patient reported that neck and head discomfort could be due to the way of lying in the bed. The patient mentioned that there was no  problems with the first dose. Patient had no treatment, just drinking water and been lying on the floor because it was cold.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 23-Jul-2021: Follow up received on 23/7/21: events outcome added.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.