chrisvoncsefalvay/vaers-outcomes huggingface dataset:
My drug test came back positive for codeine; This spontaneous case was reported by a consumer and describes the occurrence of OPIATES POSITIVE (My drug test came back positive for codeine) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     Previously administered products included for an unreported indication: COVID-19 VACCINE. Concomitant products included HYDROCHLOROTHIAZIDE and OMEPRAZOLE for an unknown indication.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced OPIATES POSITIVE (My drug test came back positive for codeine). At the time of the report, OPIATES POSITIVE (My drug test came back positive for codeine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided   This case was linked to MOD-2021-122587 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: e-mail address added.
No adverse event; patient was inadvertently administered a 2nd bivalent booster dose in mid-March using the Moderna Covid 19 bivalent vaccine.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXTRA DOSE ADMINISTERED (patient was inadvertently administered a 2nd bivalent booster dose in mid-March using the Moderna Covid 19 bivalent vaccine.) and NO ADVERSE EVENT (No adverse event) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    In March 2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In March 2023, the patient experienced EXTRA DOSE ADMINISTERED (patient was inadvertently administered a 2nd bivalent booster dose in mid-March using the Moderna Covid 19 bivalent vaccine.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXTRA DOSE ADMINISTERED (patient was inadvertently administered a 2nd bivalent booster dose in mid-March using the Moderna Covid 19 bivalent vaccine.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXTRA DOSE ADMINISTERED (patient was inadvertently administered a 2nd bivalent booster dose in mid-March using the Moderna Covid 19 bivalent vaccine.).    No concomitant information was reported. No treatment information was reported.
Exacerbation of Crohn's disease with complication. GI consulted by ER provider and she was started on IV Solu-Medrol 20 mg every 6 hourly.  She had good symptomatic relief.  Abdominal pain resolved and no further episodes of diarrhea. ED visit and hospital admission within 6 weeks of receiving the COVID vaccine.
Pt developed a burning red rash on multiple parts of his body, feet, legs, back, arm, which was it extremely itchy and painful.
10 minutes after vaccination received, pt complained of fullness feeling in throat and itchy ears and head. Epi given, pt transferred to ED, rec'd another epi and IV fluids.  Discharged after a few hours.
Systemic: Tingling (specify: facial area, extemities)-Mild, Error: Improper Storage (temperature)-, Additional Details: Tingling in back and arm.
1st dose 16Sep2016, 2nd 07Sep2022; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 75-year-old female patient who received Herpes zoster (Shingrix) (batch number P7K5P, expiry date 10th September 2023) for prophylaxis.   Previously administered products included Shingrix  (received first dose back on 16th September 2018).   On 7th September 2022, the patient received the 2nd dose of Shingrix. On 7th September 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK receipt date: 8-Dec-2022 Reporter's comment: The pharmacist called to inquired that any information available. The patient was wondering if needing an additional dose, since the doses were administered longer than recommended.  The reporter confirmed no additional doses administered just the 2 doses. Did not consent to follow-up. Additional supportive information: The patient received the second dose of Shingrix later than the recommended interval, which led to lengthening of vaccine schedule.
10 days p/immun broke out into purplish welts generalized; also has ear ache & fever (103 23APR); rash ongoing; MDthinks this react to MMR:
After receiving 2nd dose of Moderna, she felt dizzy and was diaphoretic. On site EMS responded. Vitals listed below. She was given water and cookies and was monitored. She felt better and was released to home.
my left knee started hurting/knee started screaming at me; This is a spontaneous report from a contactable consumer (patient).  An 85-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration on 22Jan2021 at single dose for COVID-19 immunization. Medical history included knee replacement (her right knee was replaced years ago). Concomitant medications were not reported. The patient reported that after getting the vaccine, her left knee started hurting on an unspecified date in Jan2021. She took some pills over the weekend that helped. But she stood up that morning and that knee started screaming at her. This was further clarified as the left knee began hurting badly when standing this morning. Clinical outcome of the event was unknown.  Information on the lot/batch number has been requested.
(Rcp)  THERAPIST, RESPIRATORY Specialty:  GENERAL, OTHER Respiratory Therapy    Addendum  Addendum    High Flow Nasal Cannula Shift Summary   Flow rate to be adjusted to reduce WOB and will be weaned as tolerated. Patient has HGH FLOW NASAL CANNULA at 50 L 80% with Oxymask at 12 L. SpO2 is between 90-94 when pulexOx is not being placed with by patient.   Patient confused, not able to give sputum sample at this time.    Admitting Dx: covid 19 pneumonia   Indications for Therapy: HYPOXEMIA    Current settings:     50 LPM  @ FiO2 80% via nasal cannula    Temperature:      37   Patient had trial off HIGH FLOW:    No      Vitals: BP 158/77  | Pulse 70  | Temp 97.6 °F (36.4 °C)  | Resp 22  | Wt 88.9 kg (196 lb)  | SpO2 93%  | BMI 27.34 kg/m²  Current ABG results:     Recent Labs   10/08/23 2252 PH 7.44 PCO2 36 PO2 52* HCO3 24.2 BE 0.8 O2SAT 86.0*     Skin assessment of area in contact with nasal interface: No problem/intact skin, patient refused skin protection.      RCP   10/9/2023   4:41 AM     Note Details  Author (Rcp) File Time 10/9/2023  4:49 AM Author Type THERAPIST, RESPIRATORY Status Addendum Last Editor (Rcp) Specialty GENERAL, OTHER Hospital Acct # Admit Date 10/8/2023  Admission (Current) on 10/8/2023  Admission (Current) on 10/8/2023   Revision History   Detailed Report  Note shared with patient Care Timeline  10/08   Admitted 2138 10/09   Transferred to ICT-INTENSIVE CARE NURSE UNIT 1240 10/11   Transferred out of ICT-INTENSIVE CARE NURSE UNIT 1713  Pt in house
19 Year old patient received 0,5mL second dose from the vial for 6 mo to 5 years olds; 19 Year old patient received 0,5mL second dose from the vial for 6 mo to 5 years olds; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (19 Year old patient received 0,5mL second dose from the vial for 6 mo to 5 years olds) and INCORRECT DOSE ADMINISTERED (19 Year old patient received 0,5mL second dose from the vial for 6 mo to 5 years olds) in a 19-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch nos. AS1414B and 059M21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Jun-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 25-Jul-2022, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to .5 milliliter. On 25-Jul-2022, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (19 Year old patient received 0,5mL second dose from the vial for 6 mo to 5 years olds) and INCORRECT DOSE ADMINISTERED (19 Year old patient received 0,5mL second dose from the vial for 6 mo to 5 years olds). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (19 Year old patient received 0,5mL second dose from the vial for 6 mo to 5 years olds) and INCORRECT DOSE ADMINISTERED (19 Year old patient received 0,5mL second dose from the vial for 6 mo to 5 years olds) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Patient Height was reported as 5 feet and 5 inches. Patient had no Allergies  No Concomitant medications were provided. It was reported that HCP accidentally vaccinated a 19 Year old patient from a vial for 6 mo to 5 years old children. patient never had COVID positive test or diagnosis.  No treatment medications were provided.
scheduled for the second Moderna COVID-19 vaccination on February 28th but couldn't go; past the dosing window; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (scheduled for the second Moderna COVID-19 vaccination on February 28th but couldn't go) and PRODUCT DOSE OMISSION ISSUE (past the dosing window) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (scheduled for the second Moderna COVID-19 vaccination on February 28th but couldn't go) and PRODUCT DOSE OMISSION ISSUE (past the dosing window). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (scheduled for the second Moderna COVID-19 vaccination on February 28th but couldn't go) and PRODUCT DOSE OMISSION ISSUE (past the dosing window) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  No treatment information was provided.
Site: Pain at Injection Site-Medium, Additional Details: Patient states she was in pain at the moment of injection and still gets nerve pain in left arm
This is in follow-up to report(s) previously submitted on 2/13/2007. Information has been received from a physician concerning a 60 year old female with diabetes who on 05-JAN-2007 was vaccinated SC in the left arm with a first dose of varicella-zoster virus vaccine (Merck) (lot # 652925/0621F). There was no illness at the time of vaccination. Subsequently later in the day on 05-JAN-2007, the patient's injection site was red, tender, itching and swollen. On 10-JAN-2007 the patient was seen in the doctor's office and was treated with Benadryl topical cream and cool compresses.  At the time of the report, the patient had not recovered. There was no product quality complaint involved.  Additional information has been requested. Additional information indicated that on 06-JAN-2007 (previously reported as 05-JAN-2007) the patient developed pain, itching, redness and swelling at the site of injection involving most of the upper arm. The patient's experiences resolved completed on 17-JAN-2007. No laboratory tests were performed. The patient had no adverse events following prior vaccinations. No further information is expected.
patient that was to get her last dose of Rabavert in the series on the 25th and did not get it that day; Case reference number US-BN-2020-019901 is a spontaneous case report initially received from a pharmacist via Agency (reference number USBAV20-0243) on 28-Dec-2020, and concerns a 63-year-old female patient.  The patient's medical history and concomitant medication details were not provided.  On 11-Dec-2020, the patient received RabAvert (Inactivated Rabies Virus Vaccine, Batch no. ARBA731A) at unknown dose for post-exposure prophylaxis.  On 14-Dec-2020, the patient received second dose of RabAvert at unknown dose for post-exposure prophylaxis.  On 18-Dec-2020, the patient received third dose of RabAvert at unknown dose for post-exposure prophylaxis.  The patient was to get her last dose of RabAvert in the series on the 25-Dec-2020 and did not get it that day (inappropriate schedule of vaccine administered).   *At the time of this repot it was confirmed that the patient did not experience any adverse event.*  Follow up information received from pharmacist on 13-Jan-2021 included confirmation that the patient didn't experience any adverse event; Reporter's Comments: Inappropriate schedule of vaccine administered is listed by convention. Reportedly, the patient did not receive the last dose of RabAvert on the day when it was scheduled which is considered to be inappropriate schedule of vaccine administered. No adverse events were reported. Inappropriate schedule of vaccine administered is not related to the vaccine itself, but to human action.; Sender's Comments: Inappropriate schedule of vaccine administered is listed by convention. Reportedly, the patient did not receive the last dose of RabAvert on the day when it was scheduled which is considered to be inappropriate schedule of vaccine administered. No adverse events were reported. Inappropriate schedule of vaccine administered is not related to the vaccine itself, but to human action.
screamed & cried inconsolable x 5 hrs p/vax lt inject site sore; no fever; mom gave APAP pt slept through noc & was alright next day;
On 04/12/01 had temperature of 102F, sensitivity to light, headache, achy and dizzy. On 04/15/01 temperature decreased and red spots noted to face and neck. On 04/17/01 spots faded.
Extreme fatigue for 36 hours after inoculation. Shoulder soreness for 24 hours. Upper arm redness for four days.
Arm rang of motion very painful . feels like bone is broke. Terrible pain when in normal use reaching  or yawning . streching. Horrible pain. Like i have been hit with a baseball bat eminating from injection sight outward to shoulder .
swelling of throat; bad headache; swelling of lymph nodes; general fatigue; feeling of chills; being under the weather; This spontaneous case was reported by a patient and describes the occurrence of MALAISE (being under the weather), PHARYNGEAL SWELLING (swelling of throat), FATIGUE (general fatigue), CHILLS (feeling of chills) and HEADACHE (bad headache) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041J21A, 003A21A and 006M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In December 2021, the patient experienced MALAISE (being under the weather), FATIGUE (general fatigue) and CHILLS (feeling of chills). On 23-Dec-2021, the patient experienced PHARYNGEAL SWELLING (swelling of throat), HEADACHE (bad headache) and LYMPHADENOPATHY (swelling of lymph nodes). At the time of the report, MALAISE (being under the weather), PHARYNGEAL SWELLING (swelling of throat), FATIGUE (general fatigue), CHILLS (feeling of chills), HEADACHE (bad headache) and LYMPHADENOPATHY (swelling of lymph nodes) was resolving.            Concomitant product use was not provided by the reporter. Treatment information was not provided. Patient was on day 5 and patient still recovering.
Headache & Myalgia Narrative: missed work following second dose due to the about symptoms
Pt presented for a WWE on December 13th. She had no abnormal findings on exam and was administered the flu shot. The pt. started having right collarbone pain with a "bump" when she woke up on Friday (Dec 14). The discomfort seemed to improve with movement, but she noticed "a bump" that was malleable. It was normal in color, temperature. It did not have any open areas, drainage or signs of infection. The bump had mild tenderness to palpation. She placed a heating pad to the area. She denied fever or other complaints. She was woken up due to the pain on Saturday morning at 0200 which was so severe she that she presented to the EC. They did not perform imaging or labs. They gave her "a shot for the pain" (TORADOL?) in the left UE which improved her pain for the next several hours. They gave her an Rx for FLEXERIL and Ibuprofen 600mg. She presented to this office (her PCP) on the 18th at noon. The pain had intensified and was radiating up the right side of her neck. Her RUE "feels like someone is pushing down on my right arm." She described numbness, tingling from shoulder to fingers. Lifting her arm causes pain as well as light pressure to the clavicle/neck/shoulder. On exam, she had tender LAD to the right subclavicular and right cervical lymph nodes. She was TTP of the shoulder and right upper back. No skin abnormalities were appreciated. There was no edema, swelling, discoloration or other abnormalities at the site of the influenza injection. She had +TTP of right proximal extremity. Skin is intact, smooth. RUE well perfused. No edema. Pulses to bilat UE equal, regular and strong. Skin color and temp. is normal. No deformities. Grip strength 5/5 and equal bilaterally. Pain with active abduction of shoulder. She is c/o numbness and tingling in the entire RUE.
Fever, vomiting, extreme fatigue, achy joints, headaches Fatigue and achy joints have been continuous since receiving vaccine
pt recv vax OCT95 & 24hr p/vax pt exp itching, rash on trunk,legs, & face;tx w/cortisone for approx 7 days & sx resolved w/in 1wk;
Sore arm at injection, muscle pain, fever, chills Fever resolved itself after 24 hours
got his first dose of the Pfizer BioNTech Covid-19 vaccine on 19Aug2021. He got diagnosed with Covid after; got his first dose of the Pfizer BioNTech Covid-19 vaccine on 19AUG2021.  He got diagnosed with Covid after; This is a spontaneous report from a contactable consumer or other non hcp. A 52-years-old male patient received bnt162b2(COMIRNATY, formulation: Solution for injection, Lot Number: UNKNOWN), via an unspecified route of administration on 19Aug2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient got diagnosed with Covid after his first dose of the Pfizer BioNTech Covid-19 vaccine on an unknown date in 2021, and was asking how long he had to wait to get the second dose. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on an unknown date in 2021.  The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow-up.
13 Jul 2021  @ 0930 seen by provider - Area of erythema present to R upper thigh 11.5 cm x 6.2 cm. Area of induration present to center of erythema measuring 3.5 x 2.8 cm. Mild warmth present. Mild tenderness present to area of induration only. Diagnosis noted as: Cellulitis noted to RLE, anterolateral aspect of right thigh. Sulfamethoxazole-trimethoprim ordered.  Follow up instructions per provider: Mother to take picture today, inner circle was documented 7/12 AM and outer circle documented today while in clinic 0900.  - Mother will send picture of this AM as well as tomorrow AM via Portal tomorrow morning for an update  - NP to call Mother after reviewed pictures in order to evaluate need to RTC or make changes  - FU sooner PRN fever, not wanting to ambulate, increased pain or fussiness, decreased appetite, not playful  - Otherwise, will FU via telephone in 24 hrs Mother states patient was also seen by health care provider on 12 Jul 2023 for same complaint. Mother states one dose antibiotics were administered at this visit.
Widespread hives, facial swelling, fever, red face, periorbital swelling Treated with benadryl and po prednisone and sx resolved over next 3 days
3 D of pain in arm - then increased itching & warm - red macular rash 17x19cm around injection site.
About 15-18 hours after vaccine, shortness of breath, dizziness, nausea, arm soreness.
Onset fever, then confusion, followed by stiff muscles at the 24hr mark. Confusion, brain fog, joint stiffness and severe arm pain continue through the 36 hour mark. By hour 72, most side effects have subsided, brain fog, confusion and extreme fatigue persist until day 5.
Information has been received from a nurse practitioner concerning a female who on an unspecified date was vaccinated with a second dose of GARDASIL vaccine (yeast) (lot number, injection site and route not reported). Subsequently the patient developed hives. The patient sought unspecified medical attention. The patient's outcome was not reported. Additional information has been requested.
BREAKTHROUGH COVID: FULLY VACCINATED WITH BOOSTER, COVID POSITIVE. PATIENT WAS ADMITTED D/T COVID+ PT C/O CHEST PAIN AND SHORTNESS OF BREATH, AND PRE PROCEDURE TEST WORK UP WAS NEGATIVE FOR ACUTE PROCESS. PAXLOVID FOR OUTPATIENT TREATMENT FOR HIGH RISK COVID PERSON.
Woke up early with chills, headache, extreme body aches and feeling exhausted.  Lasted through the following day and had to take the day off of work.  I have never had a reaction to a flu shot before and have gotten them many times.  My whole body felt like a big bruise and I was so exhausted and miserable.  Day 2 was better but still very tired and achy.
Side effects with addison disease; This spontaneous case was reported by a consumer and describes the occurrence of ADDISON'S DISEASE (Side effects with Addison disease) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ADDISON'S DISEASE (Side effects with Addison disease) (seriousness criterion medically significant). At the time of the report, ADDISON'S DISEASE (Side effects with Addison disease) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication and treatment medication were not reported.  Company comment: This is a spontaneous report. Hence, the causality is implied. Very limited information regarding this event has been provided at this time.  Further information cannot be obtained.   Reporter did not allow further contact; Sender's Comments: This is a spontaneous report. Hence, the causality is implied. Very limited information regarding this event has been provided at this time.  Further information cannot be obtained.
Site of entry was red and itchy and swollen. Patient iced area and took loratadine, the itching went away.