chrisvoncsefalvay/vaers-outcomes huggingface dataset:
10:20AM Called to assess patient as nurse states tat on the way to vaccination station, patient "tripped on the carpet". Patient states that she is status post knee replacement of left knee. Denies pain aat site BP 186/83 pulse 80. Patient relays tat knee replacement was "around 6 years ago." Once 15 minutes post vaccination observation complete, assessed left knee. No bruising redness or swelling noted at site. Patient states that "She feels fine." Discharged at 10:50A<
shortness of breath; dry cough; 103 F/(temperature) was higher earlier; not feeling well; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (shortness of breath), COUGH (dry cough), PYREXIA (103 F/(temperature) was higher earlier) and FATIGUE (not feeling well) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Pulmonary embolism (I had a pulmonary embolism about 10 years ago).   On 02-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced DYSPNOEA (shortness of breath) and FATIGUE (not feeling well). 03-Mar-2021, the patient experienced COUGH (dry cough) and PYREXIA (103 F/(temperature) was higher earlier). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and ACETYLSALICYLIC ACID, CAFFEINE, PARACETAMOL, SALICYLAMIDE (EXCEDRIN [ACETYLSALICYLIC ACID;CAFFEINE;PARACETAMOL;SALICYLAMIDE]) at an unspecified dose and frequency. At the time of the report, DYSPNOEA (shortness of breath), COUGH (dry cough), PYREXIA (103 F/(temperature) was higher earlier) and FATIGUE (not feeling well) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Mar-2021, Pyrexia: 103 (High) I had 103 F.         No Concomitant medications were reported. Treatment details included Tylenol and Excedrin. Action taken with mRNA-1273 in response to the events was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: NNI
Severe watery loose stool/diarrhea which pt contributed to his Flu/Pneumonia shots.
p/vax pt devel a rash on back, which then covered whole body, including the palms of hands & feet;2 days later rash was fading & then gone;pt sought medical attention & was treated w/ATB & pred;
patient experienced severe pain in her left arm and left shoulder; patient experienced severe pain in her left arm and left shoulder; This spontaneous report was received from a registered nurse referring to a 90 year old female patient with hypertension, osteoporosis and gastrooesophageal reflux disease. Historical drug included oxybutynin which made her felt dizzy. The patient's pertinent medical history was not provided. Concomitant therapies included losartan potassium (manufacturer unknown), omeprazole, potassium (unspecified), beclomethasone dipropionate (QVAR), furosemide, aspirin and calcium (unspecified).       On an unspecified date in 1995, the patient started vaccination with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection by intramuscular route, as routine booster. Then, on 27-MAY-2020, patient was administered another dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) by intramuscular route, in her left arm, lot #S034299 with an expiration date on 01-JUL-2021, as routine booster. One day after, on 28-MAY-2020, the patient experienced severe pain in her left arm (pain in extremity) and left shoulder (musculoskeletal pain). There was no redness or swelling of the left arm or shoulder. Patient's caregiver called the office and patient received acetaminophen (TYLENOL) as treatment; no laboratory studies were performed.  A lot check of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was requested and nurse requested a response as quickly as possible.  At reporting time, the outcome of musculoskeletal pain and pain in extremity was unknown. The causality assessment was not provided.  This is one of two reports received from the same reporter. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; manufactureraddress:; manufacturercity:; manufacturerstate:; manufacturercountry:; devicelotnumber: S034299; expirationdate: 01-JUL-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent; Sender's Comments:  US-009507513-2006USA001609:
Rash all over chest. Large red. Few areas on other body. Itchy. Also w/arm tenderness. Onset 10/9/09 mild. 10/10/09 spotty and really red.
Patient became diaphoretic and felt like "I want to pass out" immediately after receiving vaccine and reports history of syncopal event. Patient unable to recall events that lead up to the previous syncopal event.
continued to fall after the second shot; sore arm; chills; fever; hair fall completely; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ALOPECIA (hair fall completely) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A and 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported.).   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Feb-2021, the patient experienced ALOPECIA (hair fall completely) (seriousness criterion medically significant). On 15-Mar-2021, the patient experienced CONDITION AGGRAVATED (continued to fall after the second shot), PAIN IN EXTREMITY (sore arm), CHILLS (chills) and PYREXIA (fever). At the time of the report, ALOPECIA (hair fall completely), CONDITION AGGRAVATED (continued to fall after the second shot), PAIN IN EXTREMITY (sore arm), CHILLS (chills) and PYREXIA (fever) outcome was unknown.            Having treatment on her head twice a day.  Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded. Further follow-up information is expected.   This case was linked to MOD-2021-059575 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded. Further follow-up information is expected.
Muscle pain and weakness in arm of injection site. Pain occurred within about 2 hours of shot and lasted 4 days.  Additionally, 7 days after injection, redness/rash occurred at injection site. It is mildly itchy.
Initial report received on 21 September 2009 from a consumer. A 62 year old female patient with a history of asthma, arthritis, bipolar and allergies to grass, pollen, and cats developed a reaction one day after receiving FLUZONE (lot number was unknown) intramuscularly in the left deltoid on 08 September 2009. Concomitant therapy included lithium carbonate, CYTOMEL, LAMICTAL, PAMELOR, Propanolol, clorazepate. On 09 September 2009, the patient developed migraine headaches which lasted for one week. The patient also developed aches, fatigue, nausea, and a slight fever which continued to persist at the time of the report. The patient stated that she experienced the same reaction the previous year after receiving a flu vaccine (manufacturer was not specified). List of Documents held by Sender: none. This case has the same reporter as case number 2009-04091.
I95.9 HYPOTENSION 1/13/2022 CONFUSION I95.9 HYPOTENSION 1/13/2022 COVID-19 DISEASE
Pt recvd 1st dose of Hep B vax on 7OCT91 & w/in 15 minutes following vax, pt devel palpitations, lightheadedness, warm feeling all ver, SOB; EKG revealed occasional PVC's; tx DPH & Vistaril;
Rash; Swelling in her lymph nodes under her left arm; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Swelling in her lymph nodes under her left arm) and RASH (Rash) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product DUPILUMAB (DUPIXENT) for Atopic dermatitis.    Concurrent medical conditions included Atopic dermatitis.   In 2021, the patient started DUPILUMAB (DUPIXENT) (Subcutaneous) 300 milligram once a week. On 05-Aug-2021, DUPILUMAB (DUPIXENT) (Subcutaneous) dosage was changed to 600 milligram. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In September 2021, the patient experienced LYMPHADENOPATHY (Swelling in her lymph nodes under her left arm). On an unknown date, the patient experienced RASH (Rash). At the time of the report, LYMPHADENOPATHY (Swelling in her lymph nodes under her left arm) and RASH (Rash) was resolving.            No concomitant medication provided. No treatment information mentioned.  Patient would take Dupixent for treatment of Atopic dermatitis, initially 600 mg a week then reduced to 300 mg once a week. Got the Moderna booster dose, and experienced swelling in her lymph nodes under her left arm. Had the booster and got a rash as well. Was advised to stop dupixent for 2 weeks till rash was gone.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in
Information has been received from a physician concerning a 4 month old female who was vaccinated with a first and second PO dose of ROTATEQ. There was no concomitant medication. It was noted that the patient had diarrhea 2 days prior (approximately 01-NOV-2006) to second vaccination, and subsequently recovered. "Two weeks ago," on approximately 03-NOV-2006, the patient developed diarrhea for 2 days. The patient also experienced pain. At the time of the report the patient was recovering. Medical attention was sought. The physician was considering discontinuing further series of the vaccine. There was no product quality complaint involved. Additional information has been requested.
Soreness around injection site starting within a couple hours. Woke up at 9am the next morning with persistent feeling of drowsiness. Fever starting around 10:30am, peaking after a few hours at around 100-101 degrees. Full body achiness accompanying fever, with most extreme discomfort around the injection site. Symptoms responded well to Excedrin at regular intervals, although never completely went away that day. Woke up the second day feeling mostly better, although still very drowsy, fatigued, and weak for most of the day. Fever came back around 11pm, up to about 99.8 degrees, but after taking Excedrin it went away pretty quickly. Woke up feeling generally ok the third day following the vaccine, but started to get a low fever (98.8 degrees) around 2pm. Took Excedrin and feel much better.
Vaccine that administered beyond use date after the thaw process/expired vaccine administered; This spontaneous case was reported by a paramedic and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process/expired vaccine administered) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 prophylaxis.     It was unknown whether patient has diagnosed/tested positive for COVID-19. It was reported acute illness at the time of vaccination and up to one month before and chronic or long-standing health conditions were unknown.     On 28-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 28-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process/expired vaccine administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process/expired vaccine administered) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient age was reported as 37 years and 5 months.  No concomitant medication information was provided.  The vaccine was administered beyond use date after the thaw process. Patient received Moderna COVID-19 vaccine for dose 1. Reporter stated that there was no patient that had any adverse reactions and there were no reports of any reactions after the administration of vaccines.   No treatment medication information was provided.
This spontaneous report as received from a nurse practitioner refers to a group of unspecified patients. The patients were vaccinated with PNEUMOVAX 23 (date, route and lot number unknown). No other co-suspects were reported. No concomitant medications were reported. On unknown dates the patients received vaccine doses that were exposed to temperatures above 46 F for 45 minutes, with the highest temperature of 78 F for 15 minutes. No adverse effect reported. No treatment information was reported. Information about GARDASIL, RECOMBIVAX HB, PEDVAXHB and VAQTA that were exposed to temperatures above 46 F for 45 minutes, with the highest temperature of 78 for 15 minutes is also reported. This information is processed in the linked cases: 1210USA007111, 1211USA001296, 1211USA001297 and 1211USA001298. Additional information has been requested.
6/2/11 9:50 Mother called HD to state patient woke at 6:30 with shaky hands and legs also very tired.  Patient went back to bed until 9:40.  Awoke with shaky hands and legs.  Pain at injection site were IM's administered. No fever or other complaints.  Told mother to call PCP. 6/6/11 Spoke to mother today everything is fine now.  Shaking stopped on 6/3/11  Went to see PCP.
CONGESTION; FEVER; CHILLS; This spontaneous case was reported by a consumer and describes the occurrence of UNEVALUABLE EVENT (CONGESTION), PYREXIA (FEVER) and CHILLS (CHILLS) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    Concurrent medical conditions included Plaque psoriasis.   In 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Aug-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 started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced UNEVALUABLE EVENT (CONGESTION), PYREXIA (FEVER) and CHILLS (CHILLS). At the time of the report, UNEVALUABLE EVENT (CONGESTION), PYREXIA (FEVER) and CHILLS (CHILLS) was resolving.            Concomitant medication was not reported.  In 2021, Body temperature: result not provided. Treatment details were not reported.  It was unknown if patient was enrolled in a COVID-19 vaccine trial.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
2 1/2" x 1 3/4" reddened area, sore to touch;has noticed today on rt forehead reddened sl raised area; 1 1/2inch (unsure of definite relation to immun)
This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. Concomitant medication included sterile diluent. On 10-AUG-2018, the patient was vaccinated with an improperly stored VARIVAX (lot: R009409; expiry date: 29-MAR-2020) (dose and route were not reported) that was reconstituted with properly stored sterile diluent (lot: N029880, expiry date: 15-MAY-2020). The vaccine VARIVAX was exposed to 47 degree F to 77 degree F for 7 days. There was a previous temperature excursion when it was exposed to 15 degree F to 46 degree F for 7 days. The call was because of a data logger. No adverse events reported.
shaking chills for at least 4 hours; nausea; fatigue; This is a spontaneous report from a non-contactable nurse. A 68-year-old female patient started to receive bnt162b2 (BNT162B2), via an unspecified route of administration from an unspecified date at a single dose unspecified dose for an unspecified indication. Medical history included covid-19 (Prior to vaccination).  The patient's concomitant medications were not reported. It was reported that 24 hours after the first vaccine, the patient had shaking chills for at least 4 hours. She was wrapped in 2 heavy blankets and a heating pad. She also had nausea and fatigue. Symptoms gone the next day. The outcome of the events was recovered on an unspecified date.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
Within 15 minutes of the vaccine, the COVID rash I had for several months came back and was much worse.  At almost 3 weeks, the rash continues to worsen and whatver meds and lotions I am given, they do not work.  My legs and arms are covered with vesticular rashes.
Patient received High Dose Flu vaccine and within 3 hours she experienced myalgia, malaise and fever. Several hours later, she developed a fever of 102F, was nauseous and weak. She continued to experience these symptoms over the next several days.
No adverse effects; patient was vaccinated with improperly stored MMR II; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's historical condition, concomitant medications and drug reactions or allergies were not reported.   On 28-FEB-2019, the patient was vaccinated with an improperly stored dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) lot # R008031 and expiration date 18-MAR-2020 for prophylaxis (dosage schedule, route, and anatomical location were not reported). Other suspect therapy was sterile diluent for prophylaxis (dosage schedule, route, anatomical location, lot number and expiration date were not reported). The administered dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) experienced a temperature excursion above 9 degrees Celsius (8.59 C) for 15 minutes, and for sterile diluent experienced a temperature excursion above 1.18 degrees Celsius for 33 hours, as recorded by a data logger. There was no previous temperature excursion. No adverse effects reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1905USA001733:
Vaccine was stored in refrigerator on 08-Jul-2022 and administered vaccine on 10-Aug-2022; No adverse event; Patients were administered with Moderna COVID-19 Vaccine after 30-day use by date; This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients were administered with Moderna COVID-19 Vaccine after 30-day use by date), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 08-Jul-2022 and administered vaccine on 10-Aug-2022) and NO ADVERSE EVENT (No adverse event) in a 4-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1414B) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Aug-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 10-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients were administered with Moderna COVID-19 Vaccine after 30-day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 08-Jul-2022 and administered vaccine on 10-Aug-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patients were administered with Moderna COVID-19 Vaccine after 30-day use by date), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 08-Jul-2022 and administered vaccine on 10-Aug-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patients were administered with Moderna COVID-19 Vaccine after 30-day use by date) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 08-Jul-2022 and administered vaccine on 10-Aug-2022).    No concomitant product use was reported.  Vial did not undergone any temperature excursions. The healthcare professional was not aware of any symptoms for patient after the vaccine was given.  No treatment information was provided.
Right limb swelling, redness, pain at site of Dtap. Swelling 15cm.
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 13-MAR-2017, the patient was vaccinated with improprerly stored dose of M-M-R II recombinant human albumin (RHA) lot # M002418 with an expiration date 12-JAN-2018 for prophylaxis (dose, route of administration and anatomical location were not reported). There was no adverse effect reported.        Administered dose of M-M-R II experienced the temperature excursion of -14.4 degrees Celsius for 54 minutes. There was no previous temperature excursion reported. A digital data logger was involved.   This is one of several reports received from the same reporter.  Additional information has been requested.; Sender's Comments:  US-009507513-1611USA011831: US-009507513-1611USA004113: US-009507513-1705USA009742:
16 year old received both doses of Moderna vaccine, no side effects reported; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old received both doses of Moderna vaccine, no side effects reported) in a 16-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037C21A and 037C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-May-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old received both doses of Moderna vaccine, no side effects reported). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old received both doses of Moderna vaccine, no side effects reported) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and 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.