chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose was given after expiration date) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination. No Medical History information was reported. On 15-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose was given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose was given after expiration date) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. The reporter was infection control manager. Concomitant medication of the patient was not reported. Date the vial was placed in the refrigerator was 21-Sep-2021. There was no temperature excursion. The reporter reported that that there was a confusion between the expiration date printed in the carton and the expiration date when the QR code was scanned. The patient did not experience any adverse event. No treatment information was provided by the reporter. This case was linked to MOD-2022-491837 (Patient Link).
Pt admit from nursing home on 1/3/22, had recently been admitted at a different facility for COVID-19. Initial positive test 12/29/21. Febrile, SOA, tachycardia in ED. Admitted to ICU. Started on dexamethasone, remdesivir, antimicrobials. Progressed to requiring intubation on 1/6/22. Continued worsening condition, hypotension, renal failure. Changed to palliative care on 1/7/22 but family wants pt to remain on vent.
Rec'd call from Dr. 7/8/08 in reference to above pt. to confirm if child had received vaccines at our clinic.  Child has hx of lymphoma & is recovering chemo therapy.  Dx. 10/06 at different facility.  Parent did not inform nurse of/but denied any medical issues when questioned prior to receiving vaccines.
happened 5-10 mins p/vax; hard time breathing, eyes swelled-took to ER: given DPH; adm overnite;
This case was reported by a other health professional via call center representative and described the occurrence of guillain barre syndrome in a elderly female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, unknown after receiving SHINGRIX, the patient experienced guillain barre syndrome (serious criteria hospitalization and GSK medically significant). On an unknown date, the outcome of the guillain barre syndrome was unknown. It was unknown if the reporter considered the guillain barre syndrome to be related to SHINGRIX. Additional details were reported as follows: The reporter told to the field representative that the patient was hospitalized and was diagnosed with guillian barre syndrome after receiving SHINGRIX vaccine. The patient discharged and was currently undergoing physical therapy. Hospitalization dates and vaccination dates were unknown. No additional details were provided.
Pt had reaction to vaccine within 10 minutes of receiving vaccine. She reported tightness in chest, trouble breathing, shakiness, and feeling flushed and sweaty. At this point, she was given 50 mg of diphenhydramine and a bottle of water. We continued to sit with her and monitor symptoms periodically over the course of 45 minutes. As time went on, her symptoms reduced visibly until she deemed herself fit to go home. She refused a ride home, stating that "she only lives 8 minutes away." She stated that she will call as soon as she gets home to ensure her safe return. She stated understanding that she would be sleepy after a high dose of diphenhydramine, and was counseled to call emergency services if symptoms arose again.
Client became hot, was given water and ice packs to cool down and ate 2 graham crackers.  Client sat in vaccination area for approximately 30 minutes and symptoms discontinued.  Client returned to work with no further adverse effects.
please note! there was not an adverse reaction- there was  an unintentionally given extra bivalent dose- patient had a bivalent dose on 1 month prior
Patient was given Monovalent COVID vaccine as a booster. It is no longer approved for patients age 12 years and up.  Patient is not experiencing any symptoms at this time.
PATIENT WAS UNDER THE AGE OF 50 AND RECIEVED FOURTH DOSE AND DID NOT MEET ELIGIBILITY CRITERIA CURRENTLY SET. PATIENT WAS CONTACTED AND IS FEELING SLIGHTLY "RUNDOWN"  WAS COUNSLED ON TREATING SYMPTOMS. NOT DIFFERENT FROM RESPONSE TO OTHER 3 VACCINES.
Pt had near syncopal event Kw/in 5 min of receiving injection fell to floor but did not lose consciousness. VS pulse Ox and Bl. glucose of nl. HR did go from 80 to 59 but slowly recovered. Pt awake, alert and O x3. Rested in exam room x 20 min. Left in stable condition.
Patient presents today (11/8/18) with chief complaint of 2 weeks of L shoulder pain which started the morning after the vaccine. He states that he had an episode of dizziness/near fainting after the injection, but recovered after lying down briefly. He went home and woke the next morning with L shoulder pain and limited movement (although he has full ROM today on exam). He has had no injury and teaches swimming and did crew, but says he hasn't injured his shoulder.
Dose 1 and Dose 2 administered at interval of 49 days; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 and Dose 2 administered at interval of 49 days) and NO ADVERSE EVENT (No adverse event) in a 40-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     Concurrent medical conditions included Penicillin allergy, Latex allergy, Immunoglobulin G4 related disease, Mitral valve prolapse, Mitral regurgitation and Myxomatous mitral valve degeneration. Concomitant products included AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) from 01-Feb-2016 to 08-May-2023, CLONAZEPAM from 01-Feb-2022 to 08-May-2023 and MILK THISTLE [SILYBUM MARIANUM] from 01-Mar-2020 to an unknown date for an unknown indication.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 and Dose 2 administered at interval of 49 days) and NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 and Dose 2 administered at interval of 49 days) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 and Dose 2 administered at interval of 49 days).    The patient's significant medical history included slightly elevated liver function tests and body mass index of 28.7.  The patient received Spikevax dose 1 on 20-JAN and dose 2 on 09-MAR of unknown year. The patient received Nexium 24-hour from 20-FEB-2023 and doxepin 10mg at night for insomnia from 1-MAR-2023 (stopped while using Paxlovid). The COVID symptoms were far more severe (with some ongoing) including the typical symptoms (but more pronounded) productive cough with yellow sputum, Shortness of Breath (SOB). On 08-May-2023, the patient was placed on Paxlovid for COVID-19 treatment, albuterol HFA inhaler 90 mcg every 4 hours, and 2 days later Flovent 220 mcg BID due to a diagnosis of an acute bronchospasm. On 10-May-2023, the Paxlovid was last administrated. After being prescribed Paxlovid, the patient had heart palpitations and SOB worsened. After 5 doses the patient went to the emergency department where the patient found out the BP as 172/109 (normal BP was 90s/50s), mag level was 1.3 (low range for test was 1.6), and (which was to be expected) white blood cell and neutrophil count was elevated. The next day the patient experienced a sudden onset of a pounding headache, worsening heart palpitations (after a 2GM mag infusion), and dizziness. Elevated BP continued until cardiologist prescribed 0.1mg clonidine. The patient was treated with clonidine 0.1 mg twice a day.
Rosacea; Decrease range of motion and strength in arm; Little swelling; Decrease range of motion and strength in arm; Pain in shoulder, more localized to muscle of the injection site, increased pain; Chills; This spontaneous case was reported by a nurse and describes the occurrence of ROSACEA (Rosacea), HYPOKINESIA (Decrease range of motion and strength in arm), PERIPHERAL SWELLING (Little swelling), MUSCULAR WEAKNESS (Decrease range of motion and strength in arm) and ARTHRALGIA (Pain in shoulder, more localized to muscle of the injection site, increased pain) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced CHILLS (Chills). On 09-Mar-2021, the patient experienced ROSACEA (Rosacea), HYPOKINESIA (Decrease range of motion and strength in arm), PERIPHERAL SWELLING (Little swelling), MUSCULAR WEAKNESS (Decrease range of motion and strength in arm) and ARTHRALGIA (Pain in shoulder, more localized to muscle of the injection site, increased pain). The patient was treated with PENICILLIN NOS on 09-Mar-2021 for Rosacea, at an unspecified dose and frequency. On 24-Feb-2021, CHILLS (Chills) had resolved. At the time of the report, ROSACEA (Rosacea), HYPOKINESIA (Decrease range of motion and strength in arm), PERIPHERAL SWELLING (Little swelling), MUSCULAR WEAKNESS (Decrease range of motion and strength in arm) and ARTHRALGIA (Pain in shoulder, more localized to muscle of the injection site, increased pain) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided.   This case was linked to MOD-2021-042783 (Patient Link).
07/16/2021 that evening when I went to take a shower I had a large rash around my right breast, looked like red blisters also on chest area and right side of my back that looked like a rash. After taking a shower the bumps did go down, but there in the front the blister do hurt and the rash on the back hurts. Still ongoing today, but I am going to my doctor.
Narrative:  Symptoms:  & hospitalization due to COVID 12/27/20 Treatment:
She have a rash on the site of injection. It's kinda of hot as well. We have advised her to take some Benadryl and put some ice on it and if it does not get better then see Dr.
This spontaneous case, initially received from other health professional (nurse) on 01-Feb-2018, concerning a 03-year-old (child) male patient. The patient's medical history and concomitant medications were not reported. On 27-Jan-2018, 03-year-old child (under age of 4) was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: 196498 and expiry date: 30-Jun-2018). It was stated that, no adverse event was reported after the vaccination. The reporter assessed the event as non-serious. Significant follow-up received on 13-Mar-2018: It was reported that, while attempted to contact the reporter, no response have been received. Case was closed as lost to follow-up. Non-significant case correction received with IRD 01-Feb-2018: The case comment was corrected from 'the causality of the event is assessed as not related by considering the incidental nature of the event' to 'the causality of the event is assessed as not related by considering the accidental nature of the event'.
Achy sore legs, chills, sniffles, fever 99.4 began around 1:00 am and are still ongoing now at 12:07pm
stomach is hurting on the bottom left side; extremely dizzy; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (extremely dizzy) and ABDOMINAL PAIN (stomach is hurting on the bottom left side) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029A21A and 003B21A) for COVID-19 vaccination.     The patient's past medical history included Stomach pain.   On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On 03-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to at an unspecified dose. On 03-Apr-2021, the patient experienced DIZZINESS (extremely dizzy). On 07-Apr-2021, the patient experienced ABDOMINAL PAIN (stomach is hurting on the bottom left side). At the time of the report, DIZZINESS (extremely dizzy) and ABDOMINAL PAIN (stomach is hurting on the bottom left side) outcome was unknown. Not Provided
Initially,day 1:injection site irritation,then swelling and erythema, later that evening headache, nausea, neck and vertebra aching and fever (100.3). The arm remained painful, swollen and red for approx 5-7 days days. Day 2: Malaise, cont arm pain, low grade fever.  Day 3: head started itching, and with erthyema of  face with swelling of eye lids and lips, diarrhea.  About day 6: later I had a macular rash on hands, forearms, upper chest, and on the areas of both thighs and knees. Sand paper typer skin on cheeks. Face remained red, head itchy, and swollen eye lids and rash for 10-12 days. Treatment: Prednisone 40 mg daily x 5 days, zyrtec 10 mg bid, zantac 150 mg bid. started on 10/23/2019
felt hot chills; dizzy; hard time exhaling; tired; This spontaneous case was reported by a consumer and describes the occurrence of FEELING OF BODY TEMPERATURE CHANGE (felt hot chills), DIZZINESS (dizzy), DYSPNOEA (hard time exhaling) and FATIGUE (tired) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     The patient's past medical history included Open heart surgery in June 2020.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 27-Feb-2021, the patient experienced FATIGUE (tired). On 10-Mar-2021, the patient experienced FEELING OF BODY TEMPERATURE CHANGE (felt hot chills), DIZZINESS (dizzy) and DYSPNOEA (hard time exhaling). The patient was treated with DULOXETINE on 27-Feb-2021 at an unspecified dose and frequency. At the time of the report, FEELING OF BODY TEMPERATURE CHANGE (felt hot chills), DIZZINESS (dizzy), DYSPNOEA (hard time exhaling) and FATIGUE (tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.
given 3rd dose as full dose, non immunocompromised; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL OVERDOSE (given 3rd dose as full dose, non immunocompromised) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In October 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In October 2021, the patient experienced ACCIDENTAL OVERDOSE (given 3rd dose as full dose, non immunocompromised). At the time of the report, ACCIDENTAL OVERDOSE (given 3rd dose as full dose, non immunocompromised) outcome was unknown.            No concomitant medication was provided.  Patient received 3rd shot last Oct-2021 which was a full shot. A week later after getting the the full shot, they were told that the booster dose was just supposed to be half a dose.   There was not mention that patient was immunocompromised.   It was reported that, patient was now 7 months away from getting her the 3rd dose (full dose) and patient wants to know what was the best thing for patient to do.   No treatment information was provided.   This case was linked to MOD-2021-009523, MOD-2021-029511 (Patient Link).   Reporter did not allow further contact
Day 1 Severe headache (tylenol), Day 2 and 3 Sore left arm and general myalgias (ibuprofen),  Day 4 Fatigue, headache, chest pain, severe nausea, abdominal pain, lack of appetite, myalgias (rest and fluids) Day 7 Severe watery diarrhea, nausea, low grade temp, headache, abdominal cramping, sore throat, myalgias (fluids, immodium, tylenol)
12 hrs p/vax devel a large red induration on lt arm approx 5 to 6 in in diameter;
pt vax hepta B.  45 min aft vax pt passed out for 3 min. and devel red, warm, blotchy rash
Information has been received from a physician concerning an 11 year old female who on 08-FEB-2007 was vaccinated with her first dose of Gardasil and experienced flu-like symptoms after the vaccination. Concomitant therapy included Menactra. Unspecified medical attention was sought by the patient. The patient's outcome was unknown. Additional information has been requested.
Left arm deltoid 11 cm X 9.5 cm, erythematous, warm firm, to left upper arm, first four doses
Narrative: Patient received his COVID Moderna booster on 2/17/22 and on 3/14/22, he reported to his PC provider that he had been experiencing sever pain with his trigeminal nerve to the right side of his face for approx. 2-3 weeks. He had pregabalin, diazepam, tramadol and quetiapine already prescribed that he took in attempts to alleviate his pain. He declined to go the the ER for further workup. PC provider did prescribe him hydromorphone 2mg q4-6h PRN and a Naloxone kit. On 3/16/22, notes indicate that he went to a non facility where he passed away from a massive GI bleed. No notes from that facility are available. There were 27 days from time of booster vaccine to date of death. Noted diagnosis of trigeminal nerve pain was first documented in 2018. No documentation of adverse events to first 2 vaccines.
Patient received 3 vaccines - 2 in left thigh, one in right thigh. Left thigh swollen to dime size with redness. Right thigh swollen to softball size with redness and heat.
Pt was receiving immunizations at outreach clinic.  Pt was seated on exam table, and first received Menactra IM Left deltoid, then received Gardasil IM Right deltoid.  Pt went limp and lost consciousness.  Nurse was able to lay her back on exam table.  Pt. began to have a seizure: grunting, pulling legs, and moving head back and forth.  Pt. stopped breathing for a period of time.  Nurse and pt's mother stayed at her side ensuring safety.  911 was called to respond.  Pt came of out seizure and regained consciousness on her own.  Was oriented to person and place.  EMS arrived and evaluated patient, vitals and blood sugar were stable.  Patient refused transport, but was taken to Hospital by her mother.
This spontaneous report has been received from a pharmacist referring to unspecified number of patients. Information about concurrent condition, medical history or concomitant therapy was not reported. On unspecified dates the patients were vaccinated with ZOSTAVAX (dose, frequency, route and lot# not reported) for prophylaxis. It was reported that on an unspecified date the patients experienced redness at the injection sites. The outcome of the patients and the causality was not reported. This is one of the several reports from the same reporter. Additional information has been requested. Sender's Comments:  US-009507513-1702USA011420.
(R) deltoid noted with redness and swelling approx 4 1/2" T x 5" wide hot to the touch. (L) deltoid 2" T x 1 1/2" wide. Warm to the touch. Pt c/o soreness and tenderness to the touch.
Patient reports after first shingles vaccine 7/27/22 on the way home jaw  tightened up.  Night after receiving the vaccine patient reports having Headache and neck pain.  Following day pt c/o right arm numbness and pain from site of injection through  fingertips.  Symptoms resolved 2 days after the Shingles injection.
This spontaneous report as received from a other health professional refers to a patient of unknown age. On 2017 the patient was vaccinated with VARIVAX lot # M010480, unknown for prophylaxis. On 2017 the patient experienced incorrect product storage. The outcome of incorrect product storage is unknown. The reporter considered incorrect product storage to be not related to VARIVAX. This is one of several reports received from the same reporter. {Additional information has been requested. / Additional information is not expected.} Sender's Comments: US-009507513-1707USA001815: US-009507513-1708USA008729: US-009507513-1708USA008730.
numbness in left arm down to left smallest finger; numbness on both sides of jaw; shortly after the vaccine. a few hours later numbness spread to face. numbness lasted three days, but mild numbness  still occasionally occurs. was able to use arm and go about normal activities, but the numbness was noticeable and never before experienced. sudden overwhelming drowsiness throughout the first two days after the vaccine. strange burning sensation in back lower right brain. brief but notable. never felt anything like that before; occurred once the first evening after the vaccine.
First dose administered 11Mar2021,Second dose administered 16Apr2021; second dose of vaccine administered after excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (second dose of vaccine administered after excursion) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose administered 11Mar2021,Second dose administered 16Apr2021) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (second dose of vaccine administered after excursion). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose administered 11Mar2021,Second dose administered 16Apr2021). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (second dose of vaccine administered after excursion) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose administered 11Mar2021,Second dose administered 16Apr2021) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medication was reported. No treatment medication was reported.   This case was linked to MOD-2021-250544 (Patient Link).
A 73 yr old female given a SHINGRIX vaccine on 4/23/19 developed a diffuse body rash (front + back) with raised, painful, welts, "the size of jelly beans" on 4/24/19.
8 days p/vax pt began breaking out w/small red raised rash, red eyes & clear nasal drainage;rash began on neck & spread to trunk & extremities by next day;pt saw MD;
Pt describes "severe pain" and not being "able to lift arm" with onset about 2hrs after injection. Presently she presents with a local inj. site reaction including soreness, erythema, warmth, swelling, and induration. She may also have a cellulitis type reaction the skin is taught.