chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Hospitalized 11/21/2021; COVID-19 positive 11/21/2021; fully vaccinated  DATE OF ADMISSION:  11/21/2021 DATE OF DISCHARGE:  11/25/2021  DISCHARGE DIAGNOSES 1. Severe COVID pneumonia with acute hypoxic respiratory failure (this is a correction to documentation elsewhere in the chart, which did not say pneumonia.  Chest x-ray does show pneumonia.). 2. Chronic diastolic congestive heart failure. 3. Monoclonal gammopathy. 4. Paroxysmal atrial fibrillation. 5. Obstructive sleep apnea. 6. Morbid obesity. 7. Hyperlipidemia. 8. Gout. HOSPITAL COURSE An 80-year-old gentleman presented to the emergency room with increasing shortness of breath and dyspnea on exertion.  See H and P for full details.  In the ER, he was tachypneic and using accessory muscles of respiration.  COVID positive.  Chest x-ray showed interstitial infiltrates.  He was admitted and started on Solu-Medrol and Remdesivir.  Completed 5 doses of Remdesivir.  Solu-Medrol tapered over the course of the hospitalization.  Treated with IV Lasix, although his peripheral edema did not change much.  I's and O's were not accurate.  On the day of discharge, the patient was able to ambulate around the room on his home 3 L with O2 saturations staying in the mid 90s.  He felt stable for discharge.  Only minimal dyspnea on exertion was present, but he stated was at his baseline.
Tired, drowsy, lightheaded - 5" after injection. Felt tired this AM. T 98.3. Rx - hydration.
Patient 2 dose original series vaccines were administered 2/2/2022, 2/23/2022.  A booster was given erroneously on 3/17/2022.
facial swelling on the left side of face; rash on his forehead; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (facial swelling on the left side of face) and RASH (rash on his forehead) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048B21A) for COVID-19 vaccination.     Concomitant products included EMPAGLIFLOZIN (JARDIANCE), GLIMEPIRIDE, ROSUVASTATIN and LISINOPRIL for Product used for unknown indication.    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 ml. On 23-Apr-2021, the patient experienced SWELLING FACE (facial swelling on the left side of face). 23-Apr-2021, the patient experienced RASH (rash on his forehead). At the time of the report, SWELLING FACE (facial swelling on the left side of face) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
Severe cramping of all muscles of body: a 10 on "0-10" pain scale; each lasted about 5 minutes and occurred several times over the night Headache
Got a Pneumonia shot on the 17th 2018 and the 18th my arm broke out with a big purple rash kept spreading and my neck got stiff couldn't move it for days like a stroke. Got a Pneumonia shot on 10-17-18 on the 18th my arm were swollen and had big purple circle on it that itched bad and I couldn't hardly move my neck on the right side of my shoulder hurt like I was having muscle spasm back of my head hurt really bad for days couldn't even hold mu head up straight went on for a wk went to ER thought I was having a stroke had to follow up with my doctor and now my body still not right.
pt recv vax & exp shaking like was having a chill-teeth was chattering; pt begin jerking & twitching mom checked temp @ approx 2PM 100.7; 230 @ MD ofc t104
6:30-9:30pm 8/25: Fatigue, Headache (moderate), Chills (severe),  nausea (mild). 9:30pm 8/25 - 3:00pm 8/26: fever(99.9-100.4 F) body aches (severe), headache (moderate). 3:00pm - 11pm 8/26 fever(99.1-99.9), dizziness. Took Tylenol as recommended on bottle (2 every 4 hrs), sipped fluids, rested - I am pregnant unable to take other meds or hot bath, etc.
Administration error due to language barrier. patient got pfizer bivalent booster instead of primary series. there is no adverse event occurs. Patient is completely  normal.
Patient age 15, 11 months was vaccinated with Pfizer, which is a vaccine error, His vaccine card indicates he received Pfizer #1 on 4/07/2021.  Troubleshooting: Original scribe and vaccinator did not validate age or the information available on vaccine card;  this was identified by Dr., who stated she was comfortable having him receive the second vaccine a week before his 16th birthday.  At the time the original unreported error was made we did not have a policy on checking ID. In the computer, he lists himself as of legal age.
Pt received vaccination on 04/02/2002, 24-48 hrs later swelling, no fever, not ill, elevated.
left leg is totally weak; could hardly walk; leg cramped up; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (left leg is totally weak), GAIT DISTURBANCE (could hardly walk), VACCINATION SITE PAIN (sore arm) and MUSCLE SPASMS (leg cramped up) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     The patient's past medical history included Lung nodule and Environmental allergy. Concomitant products included FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR), VITAMINS NOS and HYDROCHLOROTHIAZIDE, TRIAMTERENE (MAXZIDE) for an unknown indication, CHLORPHENAMINE MALEATE (ALLERGY tablet [CHLORPHENAMINE MALEATE]).    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced VACCINATION SITE PAIN (sore arm). On 24-Feb-2021, the patient experienced MUSCULAR WEAKNESS (left leg is totally weak), GAIT DISTURBANCE (could hardly walk) and MUSCLE SPASMS (leg cramped up). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Pain, at an unspecified dose and frequency and PARACETAMOL (TYNELOL (might take next)) at an unspecified dose and frequency. At the time of the report, MUSCULAR WEAKNESS (left leg is totally weak), GAIT DISTURBANCE (could hardly walk), VACCINATION SITE PAIN (sore arm) and MUSCLE SPASMS (leg cramped up) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Patient waited 15 minutes in front of pharmacy without incident. As she was leaving the store at 20 minutes after the shot she began to feel faint and requested a chair to sit down. Patient appeared pale and was sweating profusely and complained of nausea. After about 10 minutes of sitting down she states she was feeling better and left the store on her own accord.
Got the incorrect bivalent booster.  She got dark blue cap (grey label) ? 0.25ml. She should have gotten dark pink cap (yellow label) ? 0.2ml.  No adverse events
NEXT DAY STARTED GETTING COUGH, CONGESTION, DYSPNEA, MALAISE, LOSS OF TASTE, LEFT ARM PAIN. GRADUALLY WORSENED, PERSISTING.
This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown age and gender. Patients' pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On unknown dates, patients were vaccinated with improperly stored doses of VAQTA (lot # M021124 and expiration date 02-FEB-2018, dose and route of administration were not reported). The temperature of excursion was minus 2 Celsius degrees and the time frame was 20 hours. The conditions were back in range at the time of the report. There was no previous temperature excursion. It was stated that it was because of a data logger. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
The vaccine triggered significant hot flashes occurring every 30 minutes 24 hours a day, making it difficult to get a full nights sleep. I was not having hot flashes before I got the Pfizer vaccine.  I began having hot flashes after the second shot in the series in May of 2021 but didn't immediately realize it was the shots that triggered them. The hot flashes subsided a little bit about 6 months after the 2nd shot. However, when I got the booster shot in December, the hot flashes came back even worse.  Here we are more than 30 days later and they still have not subsided, again, making sleep difficult.
approx 48-72 hr p/vax had inc in tenderness, redness & induration @ site in approx 3-4 inch diameter area;
3 OCCURENCES OF V. FIB FROM WHICH HIS IMPLANT SAVED HIM. HE HAS ALSO HAD SIGNIFICANT WATER RETENTION
Pt states as 10/13 "pulsing". Feeling on inner aspect of L arm.
Given vaccines (PEDIARIX, PREVNAR)-cried afterwards, then given neb. tx (albuterol)-still crying x 10 minutes. Dad came out of exam room to notify staff infant broke out in red rash to face, torso, arms, leg. No swelling, no breathing difficulty, no SOB-observed x 30 minutes-normal exam rash resolved. Pt sent home w/ instructions to call for any further reactions 911/vaccine like adverse.
"COVID Arm" - red itchy rash at injection site approximately 3 inches wide and tall.  Advil taken and cortisone applied to rash.  Began on day 8 after injection, still ongoing.
pt nursing home records, pt has had a history of COVID (10/8/21); pt died in the nursing home per death certificate with causes of death being:  metabolic encephalopathy and COVID 19
Left Patellar and peri Patellar Severe pain, swelling, point and generalized tenderness, no weight bearing, questions re. Reaction to vaccine triggering severe Gout versus septic joint - no fever improving course over next 6 days with increased hydration and typical treatments for a Gout flare. Have had X 2 the past five years w/ this being the most severe - low purine/low NA diet no triggering traumatic event. Resolving course.
Had typical side effects (malaise, injection site tenderness) for 1-3 after injection on January 5, 2021  Ten days following the injection - January 15 - she developed a red, warm, nonpruritic, nontender, non-raised rash around the injection site approximately 4 inches diameter, along with bilateral axillary lymph node tenderness L>R.  She felt well otherwise.  Rash  resolved on January 19.  Lymph node tenderness also receding on January 19.
Initial unsolicited report received from a pharmacist on 25 September 2015. This case involves a female patient (age not reported) who was vaccinated with a 0.5 ml intramuscular dose of FLUZONE (batch number, site of administration were not reported, from prefilled syringe) on an unknown date. Patient's medical history and concomitant medications were not reported. On an unspecified date, within hours following the vaccinations, the patient experienced rash and swelling near her elbow. The patient went to her physician where it was diagnosed as cellulitis. Lab data and corrective treatments were not reported. The outcome of events was unknown. Reporter causality for the event cellulitis was reported as unknown. Upon internal review, the company decided to consider the event serious because of important medical event: Cellulitis. List of documents held by sender: none.
she started feeling tired 4 days ago; After 1 week, she started with swollen left arm and it was hard; hot to touch; red; very itchy; It went from injection site to the elbow and She went to urgent care; doctor diagnosed it as a covid arm; Next day she discomfort on her left arm; Chills; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (Next day she discomfort on her left arm), CHILLS (Chills), PERIPHERAL SWELLING (After 1 week, she started with swollen left arm and it was hard), FEELING HOT (hot to touch) and ERYTHEMA (red) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     no medical history was reported.     On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced LIMB DISCOMFORT (Next day she discomfort on her left arm) and CHILLS (Chills). On 13-Apr-2021, the patient experienced PERIPHERAL SWELLING (After 1 week, she started with swollen left arm and it was hard), FEELING HOT (hot to touch), ERYTHEMA (red), PRURITUS (very itchy), INJECTION SITE PAIN (It went from injection site to the elbow and She went to urgent care) and VACCINATION SITE REACTION (doctor diagnosed it as a covid arm). On 24-Apr-2021, the patient experienced FATIGUE (she started feeling tired 4 days ago). At the time of the report, LIMB DISCOMFORT (Next day she discomfort on her left arm), CHILLS (Chills), PERIPHERAL SWELLING (After 1 week, she started with swollen left arm and it was hard), FEELING HOT (hot to touch), ERYTHEMA (red), PRURITUS (very itchy), INJECTION SITE PAIN (It went from injection site to the elbow and She went to urgent care), VACCINATION SITE REACTION (doctor diagnosed it as a covid arm) and FATIGUE (she started feeling tired 4 days ago) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
reached a low temperature of Negative 1.3 C and were out of range for 9 hours and 48 minutes with no adverse event; FLUZONE QIV NP PFS was administered to patient post temperature excursion with no adverse evevnt; Initial information received on 16-Feb-2023 regarding an unsolicited valid  non-serious case received from a other health professional.   This case is linked to cases 2023SA054981(CLUSTER) and 2023SA057733(CLUSTER).   This case involves child patient of an unknown gender and reporter reported Influenza Quadrival A-B Vaccine [Fluzone Qiv] reached a low temperature of negative 1.3 c (clesius) and were out of range for 9 hours and 48 minutes and was administered to patient post temperature excursion with no reported adverse event.   It is unknown if the patient had any medical history, medical treatment (s), concomitant disease or risk factor.   On an unknown date, the reporter reported Influenza Quadrival A-B Vaccine, Suspension for injection (lot number: UT7683NA, UT7682JA; Expiry date: 30-06-2023) reached a low temperature of negative 1.3 c and were out of range for 9 hours and 48 minutes and was administered to patient post temperature excursion with no reported adverse event (product storage error) (poor quality product administered,latency: same day) (with an unknown strength, dose) via unknown route in unknown administration site for prophylactic vaccination (Immunisation).   It is unknown if the patient experienced any additional symptoms/events   It is unknown if there were lab data/results available.   Action taken: not applicable.   Outcome:  Unknown for both the reported events   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.   This situation is reported as a medication error due to temperature excursion that exceeded the stability data documented in the local labelling and additional supporting stability data.
Information has been received from a pharmacist and a registered nurse (clinical coordinator) concerning a 75 year old female with a history of a rash on 27-FEB-2007 and herpes zoster who in April 2007, was vaccinated with a 0.65 ml dose of Zostavax. subsequently the patient presented to the emergency room with a mild case of shingles/herpes zoster. The patient was treated with acyclovir and told to follow-up with her family physician. It was reported by the nurse that the patient had not been seen in the office since February 2007. It was reported that the patient was recovering. There was no product quality complaint involved. No further information was provided. Additional information has been requested.
received one vaccine 5 months ago; 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 PRODUCT DOSE OMISSION ISSUE (received one vaccine 5 months ago) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (received one vaccine 5 months ago). At the time of the report, PRODUCT DOSE OMISSION ISSUE (received one vaccine 5 months ago) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant Concomitant medications were reported.   No Treatment information for the event was provided. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 20-May-2021 and was forwarded to Moderna on 21-May-2021.    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 PRODUCT DOSE OMISSION ISSUE (received one vaccine 5 months ago) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (received one vaccine 5 months ago). At the time of the report, PRODUCT DOSE OMISSION ISSUE (received one vaccine 5 months ago) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant Concomitant medications were reported.   No Treatment information for the event was provided.
Cytomegalovirus 1/11/2021 full, who presents with rectal pain. He has COVID-19 since Tuesday December 28, 2021, and received an infusion of monoclonal antibodies on Sunday January 2, 2022.
This spontaneous report was received from a physician via a company representative, referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 28-OCT-2015, the patient was vaccinated with an improperly stored dose of VAQTA "25U/0.5ml-SD LLok wCap Ped" which had a lot number of L02259 and expiration date on 06-APR-2017 (route of administration and anatomical location were not reported). There were no concomitant medications provided. No adverse effects reported. No product quality complaint was involved. On an unspecified date, the VAQTA vaccine had one temperature excursion of 48 hours. The lowest recorded temperature was 34 F (1.111111111 Celsius) and the highest recorded temperature was not mentioned. The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator (R)". This is one of several cases from the same reporter. Additional information has been requested.
7 days post vax t105.5 R x 3 days;prior to vax seen for cold lasting 12 days w/low grade temp;MD said not contraindicator-diarrhea, vomit;not eating x 2-3 days;lethargic, not responding;
08/27/02 - Pains in right leg, Right ankle of foot swollen, RX: Motrin 08/28/02 8 pm fever 102 F, right foot and ankle worst unable  Went to hospital ER, Sed Rate=83; 08/30/02 Saw doctor, Sed Rate 09/09/02 =62, 09/23 = 50, 10/07/02 Sed  Rate =87, No med now.
Dizziness, Hallucinations, Headache, Fever, Shivering/tingling from scalp to toes Narrative:
This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of (Merck) VARIVAX, (dose, route of administration, injection site, lot number and expiration date were not reported). No adverse effects were reported. No product quality compliant (PQC) was involved. Follow up information has been received on 18-MAY-2015 and on 19-MAY-2015 form the reporting medical assistant and the physician, respectively. The physician information regarding the patients identifiers, lot number and date vaccination. It was reported that the patient was vaccinated with an improperly stored dose of (Merck) VARIVAX, lot number K015970 on 09-MAR-2015. This is one of several reports from the same reporter. Additional information has been requested.
Febrile seizure including shaking and jerking of limbs, stiffness, blue lips, eyes rolling back, loss of consciousness (2 minutes or less). Temp of 103.6.
About 45 to 60 minutes after receiving the vaccinations, pt. stated he started to feel warm, his heart started racing, and he had difficulty breathing.  He was feeling some slight heart pain.  His face turned red and he experienced blurred vision.  He was taken by paramedics to the Emergency Department at a nearby hospital.  At the ER, he was informed that he had hypertension, low blood sugar and a UTI.  (note; he did not eat prior to receiving the vaccinations)
Woke in AM feeling very dizzy, with serious balance issues; motion in peripheral vision; slight nausea. Cautioned by primary care physician in June to get immediate care if experiencing stroke symptoms (acute stroke diagnosed on June 17, 2022 MRI - recent within 2 - 3 weeks prior to MRI - however, experienced no common symptoms of stroke) (Moderna Booster vaccine on 4/15/22). Went to Urgent Care, Dr. examined and determined symptoms to be consistent with vertigo.  No additional MRI was ordered, however, later visit w/neurologist has ordered an MRI to rule out 2nd stroke.  Still waiting for appointment for MRI.  Symptoms of vertigo slowly disappeared within approximately 2 weeks. June 17, 2022 MRI discovered evidence of Acute Stroke, Left. Small acute/subacute left cortical infarct parietal gray matter.  MRI was ordered on June 9, 2022 by primary care physician at annual physical due to complaints of some problem with word retrieval.  No other symptoms were experienced.  Was advised the stroke was recent, within 2 - 3 weeks prior to MRI. (Moderna booster administered prior to stroke on 4/15/22)