chrisvoncsefalvay/vaers-outcomes huggingface dataset:
mild side effects; 3 times since then for 2-3 days each time, he experiences chills, fever and weakness/ mild symptoms; Weakness; Fever; Chills; COVID infection in April; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID infection in April), ADVERSE EVENT (mild side effects), SYMPTOM RECURRENCE (3 times since then for 2-3 days each time, he experiences chills, fever and weakness/ mild symptoms), ASTHENIA (Weakness) and PYREXIA (Fever) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Surgical intervention (Heart surgery) in 2007. Concomitant products included ATORVASTATIN, METOPROLOL, AMLODIPINE, LEVOTHYROXINE, TAMSULOSIN, HYDROCHLOROTHIAZIDE and GABAPENTIN for an unknown indication.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Apr-2021, the patient experienced COVID-19 (COVID infection in April). In July 2021, the patient experienced ASTHENIA (Weakness), PYREXIA (Fever) and CHILLS (Chills). On an unknown date, the patient experienced ADVERSE EVENT (mild side effects) and SYMPTOM RECURRENCE (3 times since then for 2-3 days each time, he experiences chills, fever and weakness/ mild symptoms). On 25-Apr-2021, COVID-19 (COVID infection in April) had resolved. At the time of the report, ADVERSE EVENT (mild side effects), SYMPTOM RECURRENCE (3 times since then for 2-3 days each time, he experiences chills, fever and weakness/ mild symptoms), ASTHENIA (Weakness), PYREXIA (Fever) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.         No treatment medication was provided. Reporter took his father to the doctor and they did some blood work which showed no signs of infection.   This case was linked to MOD-2021-262541 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: Follow up received  contains significant information: email has been updated and New events are added-Mild side effects and Symptom recurrence.
On the evening of 12/4/01, mother noticed "nickel-sized" area of redness on left deltoid. This progressed rapidly to involve entire left upper arm, shoulders to elbow and area was 1 1/2 size of normal arm with "extreme" pain and "heat" at the site. Child was unable to move arm. Mother called nurse advice line 2 times, 12/4/01 and 12/5/01 and took to MD on 12/5/01 in the PM. Dx'd with cellulitis. Rx'd Keflex liq. 2 x day X 1d. Mother noted improvement on the evening of 12/6/01. Child also had had a low-grade temperature throughout the course of events.
Moderna Monovalent vaccine was administered to 3 adult patients after after manufacturer date of expiry; No adverse event; Moderna Monovalent vaccine was administered to 3 adult patients after after manufacturer date of expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna Monovalent vaccine was administered to 3 adult patients after after manufacturer date of expiry), PRODUCT STORAGE ERROR (Moderna Monovalent vaccine was administered to 3 adult patients after after manufacturer date of expiry) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 015B22A) for COVID-19 prophylaxis.     No Medical History information was reported.  On 24-Feb-2023, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 24-Feb-2023,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna Monovalent vaccine was administered to 3 adult patients after after manufacturer date of expiry). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Moderna Monovalent vaccine was administered to 3 adult patients after after manufacturer date of expiry) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna Monovalent vaccine was administered to 3 adult patients after after manufacturer date of expiry), PRODUCT STORAGE ERROR (Moderna Monovalent vaccine was administered to 3 adult patients after after manufacturer date of expiry) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (Moderna Monovalent vaccine was administered to 3 adult patients after after manufacturer date of expiry) and PRODUCT STORAGE ERROR (Moderna Monovalent vaccine was administered to 3 adult patients after after manufacturer date of expiry).    No concomitant medications were reported.  The vial was initially stored in the refrigerator on 23-Feb-2023.  It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19.  The vial did not undergo any temperature excursions.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-712769, US-MODERNATX, INC.-MOD-2023-712775 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-712769:Patient 2 US-MODERNATX, INC.-MOD-2023-712775:Patient 3
he got slight fever; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number was not reported) via an unspecified route of administration on 26Apr2021 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 05Apr2021 as dose 1, single for covid-19 immunisation. The patient stated that he got the second dose yesterday 26Apr2021 and mentioned that he got slight fever on an unspecified date in Apr2021. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
The Covid-19 shot was injected at 3:40pm. The patient stated at 3:50pm the she was feeling dizzy and lightheaded. The pharmacist sat with her, 911 was called at 4:10pm. The patient was alert and never loss consciousness. She was transported by EMT to a hospital.
He was limp, unresponsive (as if he wasn't there) when you waved your hands in front of his open eyes. He also kept startling at the slightest noise. Seizure type reaction; duration at least 1/2 hour. Was later dx'd with "Autistic Encephalopathy".
07/15/2005 Stepmom called with report of crying, pain, edema at injection site at 4PM.  Later child taken to ER with diagnosis of "a little bit of infections and prescribed antibiotic."  Redness, edema, pain at left deltoid.
COVID infections; COVID infections; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 45 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 04Nov2021 (Lot number: 320308D) at the age of 45 years as dose 3 (booster), single, administration date 24Mar2021 (Lot number: EP6955) as dose 2, single and administration date 01Mar2021 (Lot number: EL3247) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: IMMUNISATION (medically significant) with onset 04Nov2021, outcome "unknown", described as "Booster"; DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 03Jan2022, outcome "recovering" and all described as "COVID infections". Therapeutic measures were not taken as a result of drug ineffective, suspected covid-19.  No follow-up attempts are possible. No further information is expected.
patient was dizzy and shaken and nauseated about 15 minutes after receiving the vaccine. She progressed to feel more week after 5 more minutes. 911 was called and patient was taken to the hospital
8 days later developed welt on leg 1/2"  long at injection sight. Still has bruise on leg. Started stomping foot of left leg while walking. Started twitching while sleeping. Right ear had skin irritation and cracking. Left foot between 2nd and 3rd toe skin irritation and cracking.
Rush on (L) ant thigh at site of injection diffuse erythematous blanching approx. 2-3 cm diameter no papules, vesicles, or pustules x 6 days appeared few days after vaccine administration. Tx: KEFLEX x 10 days. Resolved 3 days, staring PO ABX. No complications.
eye watering and redness; eye watering and redness; This is a spontaneous report from a contactable consumer. A female patient (Reporter's coworker) of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 12Mar2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced eye watering and redness. It was reported that patient experienced similar symptoms and was going to follow up with her eye doctor. The outcomes of events were unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
About 2 days after receiving the moderna, I noticed some chest pains/tightness localized to my heart area. I would literally say it feels like my heart is swollen or inflamed. I also sometimes feel a ?pinching? feeling under my left armpit if my heart rate increases. I still suffer from these effects to this day.  It?s basically 24/7 I feel this uncomfortable feeling around my heart, even 6 months later. It will not go away no matter what.
I have had COVID-19 around Nov. 27, 2020. The symptoms I started having were like a more moderate version of the same symptoms I had had during COVID.  Head arch, sore body, weakness, chills, a little shortness of breath with a slight cough.  Right now at 2:37 PM on 3/26/2021 I feel about like I did on day 3 of when I had COVID. I still have some of the symptoms, but they are much more diminished.
Pt. experienced vasovagal response 10 minutes post vaccine administration.  Recovered and had 2nd episode approximately 15 minute later.
back started hurting; pain moved to the back of her right arm into her right fingers and across the right side of her chest---pain is incapacitating, debilitating; Burning pain; Throbbing pain; Nerve pain/Horrible back pain flowing in the nerve pathway; she could not sleep; fever; tiredness; chills; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (back started hurting), PAIN (pain moved to the back of her right arm into her right fingers and across the right side of her chest---pain is incapacitating, debilitating), PAIN (Burning pain), PAIN (Throbbing pain) and NEURALGIA (Nerve pain/Horrible back pain flowing in the nerve pathway) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040B21A and 007B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced BACK PAIN (back started hurting), PAIN (pain moved to the back of her right arm into her right fingers and across the right side of her chest---pain is incapacitating, debilitating), PAIN (Burning pain), PAIN (Throbbing pain), NEURALGIA (Nerve pain/Horrible back pain flowing in the nerve pathway), INSOMNIA (she could not sleep), PYREXIA (fever), FATIGUE (tiredness) and CHILLS (chills). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, BACK PAIN (back started hurting), PAIN (pain moved to the back of her right arm into her right fingers and across the right side of her chest---pain is incapacitating, debilitating), PAIN (Burning pain), PAIN (Throbbing pain), NEURALGIA (Nerve pain/Horrible back pain flowing in the nerve pathway), INSOMNIA (she could not sleep), PYREXIA (fever), FATIGUE (tiredness) and CHILLS (chills) outcome was unknown.            No concomitant medications were provided.  She had used Advil, tried to rest, heat, nothing  worked.   This case was linked to MOD-2021-103499 (Patient Link).
Expired vaccine was stored in refrigerator on 04 Apr 2022 and administered on 15-Apr-2022; Expired vaccine administered to 155 patients; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 155 patients) and PRODUCT STORAGE ERROR (Expired vaccine was stored in refrigerator on 04 Apr 2022 and administered on 15-Apr-2022) in a 79-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 15-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 155 patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Expired vaccine was stored in refrigerator on 04 Apr 2022 and administered on 15-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 155 patients) and PRODUCT STORAGE ERROR (Expired vaccine was stored in refrigerator on 04 Apr 2022 and administered on 15-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The vial was stored in refrigerator on 04 Apr 2022. The vial did not undergo temperature excursion.  No treatment medications were reported.       This case was linked to MOD-2022-551714 (Patient Link).
Within a minute after receiving the shot, I felt dizzy, then passed out completely. While passed out I was noted to be extremely pale & had trouble breathing. Within a few minutes I was awake & aware again. Felt nausea a few minutes after that. Within the next 30 minutes I slowly begin to feel more normal.
Pt recvd 3 doses of Engerix-B 1NOV90, 27NOV90, & 6MAY91 & 3SEP91 it was determined that pts titer was neg p/3 doses of Engerix-B;
Patient was completing second dose of SHINGRIX series. She only experienced a sore arm with the first dose but the second dose gave her severe uncontrollable shakes, headache, and nausea.
Herpes simplex erupted in right buttock. Added acyclovir for 10 days to daily meds. 24 hours after vaccination tonsils, right side erupted. 48 hours after vax at doctors office who specified infection was viral bcs got better without antibiotics. Tonsils never went back to normal. Tonsils were swollen, but could swallow, did not hurt or developed coating.
patient called this morning stating that her armpit/shoulder and down her side was in severe pain on scale 7 (level pain 1-10). She then called back and stated that she went the hospital and was examed/CAT scan to see if there were any issues.
ACUTE ON CHRONIC RESPIRATORY FAILURE 4/25/2023 HYPERLIPIDEMI, HYPERNATREMIA
Acute myocarditis; Chest pain; A spontaneous report was received from a physician concerning (patient age: unknown) male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced chest pain, acute myocarditis (myocarditis).  The patient's medical history included COVID-19 in Mar 2020 and was exposed and may have had it a second time in Nov 2020. Concomitant medications were not provided.  On 12 Mar 2021, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Lot number: 038A21A) intramuscularly for prophylaxis of COVID-19 infection.  On 15 Mar 2021, the patient developed chest pain and was admitted to the hospital. The patient underwent cardiac catheterization, echocardiogram and cardiac MRI (magnetic resonance imaging). Results of the echocardiogram and cardiac MRI were not provided. The final diagnosis of the patient  was acute myocarditis. COVID antibodies were positive, about 561 for the patient. The events chest pain and acute myocarditis lead to hospitalization. Treatment activities for the events were unknown.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of events, experienced chest pain and acute myocarditis, was unknown.; Reporter'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.
Complains of dizziness, stomach pain and radiating pain down right arm. Patient was seen at ER; per patient's mom stated "needle hit a nerve".
Light headed, stomach upset, 5- 10 min after. Chest, tightness 10 min epi and Zyrtec given.
Approximately 2 hours post vax the injection site was painful. One day post vax the injection site was swollen, red, splotchy with fever.
Hospitalization: 1/31/2023 - 2/10/2023 (10 days) Presentation to the ED: respiratory distress COVID + date: 1/31/23 Treatment: bronchodilators.  Discharge to: home. 002A21A 3/12/2021 046B21A 4/9/2021 035C21A 11/19/2021 002M21A 4/28/2022
Seen 10/18/07 for pneumovax injection. Given vaccine left deltoid IM. On 10/19/07 was seen at office with Left upper arm swelling and redness. Red area 3x 5 inches and very warm to touch. Fever, no temp taken at home (felt feverish) and nauseated. Symptoms started 6 hours after receiving pneumovax
Sore arm, pain on right side of hip and rear end, tingling sensation,  started breaking out in Shingles on the right side from top of rear end to the bottom of rear end
Initial report received from healthcare professional on 12 August 2013. A 64-year-old female patient, whose concomitant medications were not reported, had received a dose of ACT-HIB (batch number, dose number, route and anatomical site of administration were not reported) on 09 August 2013. The patient was allergic to sulfa drugs and a history of lupus. On 10 August 2013, the patient experienced generalized red, raised rash like hives. Corrective treatments and laboratory investigations were not reported. At the time of this report, the outcome was not reported. Documents held by sender: none. Follow-up information received from a healthcare professional  on 25 October 2013. On an unspecified date, the patient had recovered.
NUMBNESS OF RIGHT FOOT TOE ABOUT 1AND 1/2 WEEK AFTER 1 ST  DOSE
Few red spots appeared around waist on 12/17/2021 evening (one day post booster shot).  Clusters of rashes developed and extended to the back of waist on 12/18/2021.  Not itchy.  Pain all around the waist developed on 12/19/2021 and observations of small blisters.  Medically confirmed Shingles on 12/20/2021.  Treatment:  Valacyclovir oral 1gram three times per day for 7 days.  Analgesics include Tylenol and Advil Blisters resolved on 12/27/2021.  Pain still on going as of date of report. Constipation started 12/23/2021.  Treatment prescribed:  Docusate sodium 100mg daily and Senna 15mg daily since 12/27/2021.  Ongoing.
patient reported that after getting flu shot her arm has been sore, she has been taking tylenol for the pain and physical therapy,"The therapist encouraged me to continue the with exercise as this kind of Injury can persist for a long time" .heating pad helps with the symptoms for a short period of time
patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 67-year-old male patient 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) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Caller was an (Privacy). She stated that because their facility had not been able to download the digital data logger for the months of Dec2021, Jan2022, and Feb2022, they had been put on hold by the state at the moment and could not administered the Moderna COVID-19 vaccine to patient's until an assessment by the state was made.  There had been no power outages that would have impacted the Moderna vaccine. However, she reiterated that because her facility was unable to download the digital data logger, they would need to treat this issue as a temperature excursion. No adverse event reported.  No treatment medications were reported.
Within first hours warmth in left arm, injection site. Followed by warmth on left leg, Mild Headache that night relieved with Ibuprofen. Mild Pain at injection site that night and the next day.
Medical professional administering vaccine drew up 1ml instead of the recommended dosage of 0.5ml.
loss of taste; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (loss of taste) 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 AGEUSIA (loss of taste). At the time of the report, AGEUSIA (loss of taste) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitants were reported. No treatment was reported.
Day after vaccination patient presents with bullae and keloid formation around the vaccine administration site in his right arm. The patient is currently treating it with topical cortisone and was recommended to visit his primary physician.
Severe debilitating headache and full body aches. Insides felt like they were on fire. Severe sweating and nausea.  Arm continued to swell and redness spread at injection site.