chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Apr-2021 at 9:46 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Apr-2021 at 9:46 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient age was reported as 57.96 No concomitant medications were reported. The vial underwent temperature excursion on 03-Apr-2021 with temperature 34 degrees Fahrenheit and the vial was initially moved to the fridge on 30-Mar-2021 and proposed beyond use date was 29-Apr-2021. The vial got moved to clinic on 03-Apr-2021. The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. It was reported that each time a vial was put into a cooler, sometimes there was a period of time of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34 or 35 degree Fahrenheit. On the date of administration, at 08:00 A.M., the temperature recorded was 38 degree Fahrenheit and at 09:00 A.M., the temperature recorded was 34 degree Fahrenheit that has been reached by the vial. Temperature recordings were taken using a traceable temperature monitor at every hour. The vial was not in a frozen state at the time of vaccine administration. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature. No treatment information was provided.
Narrative: Pt is a 68y.o. male who died on 04/22/2021 w/ h/o HTN, Hep C, Hypercalcemia, HLD, Elevated liver enzymes, Cholelithiasis, Hepatocellular carcinoma. Pt received Moderna Covid-19 Vaccination 2/2 on 03/08/2021. Unlikely that Moderna Covid-19 Vaccine caused/contributed to pt death.
w/in a couple of hrs p/immun, pt had episodes of intemittent screaming (5 min @ a time) for nex 12 hrs; Also, quite irritable, t101 AX, lethargy, dec appetite & 2 episodes of projectile vomiting; pt recovered;
Information has been received from a physician concerning a 14 year old female who on 05-NOV-1996 and 16-AUG-1999 was vaccinated with the first dose and the second dose of MMR II respectively.  On 18-NOV-2009 the patient experienced mumps.  On 30-NOV-2009, the patient was diagnosed and the patient was afebrile.  The patient had left and right parotitis.  The parotitis count was 54.  At the time of the report, the patient's status was unknown.  Follow up information has been received from a physician reported that on 10-NOV-2009 the patient experienced mumps.  On 12-NOV-2009 the patient was diagnosed.  The patient's body temperature was 100.5 degree Fahrenheit.  The patient had left parotitis.  On the same day, the first blood work revealed that serum immunoglobulin M 1:10, serum immunoglobulin G 5.42 and serum amylase 581.  It was also reported that the patient was 13 years old at the time of onset.  Additional information has been requested.
patient felt dizzy after vaccine. BP was checked 111/68, pulse 68 O2 96
Vaccine given on 10-31-2006. Arm turned red and swelling within a few hours. Very painful. Temp 100F by 7 pm. Went to hospital. ER doctor confirmed a reaction. Use "ice" and go back to doctor. Went back to doctor on 11/01/06 was told it was cellulitis and given amoxcillan 500 mg for 7 days.
arm pain; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 31st August 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient received the 1st dose of Shingrix in her right arm and she had arm pain with that, which was resolved. For tolerance to 2nd dose of Shingrix, refer linked case US2020225597, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020225597:same patient 2nd dose
Fever up: 102.3 Axillary, Crying, Wanting to be held, low appetite.
I was shaking; my breathing was fast; I was unable to stand; my heart rate was extremely high 115 to 120; my blood pressure was high; I was peeing straight blood; really sleepy; Chills; Fever 100.4 F; Very Cold; Lethargic; Low energy; Mild Body Ache, Body aches; Tired; Headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LETHARGY (Lethargic), ASTHENIA (Low energy), NASOPHARYNGITIS (Very Cold), TREMOR (I was shaking) and RESPIRATORY RATE INCREASED (my breathing was fast) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included UTI.    On 14-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-May-2021, the patient experienced LETHARGY (Lethargic), ASTHENIA (Low energy), HEADACHE (Headache), MYALGIA (Mild Body Ache, Body aches) and FATIGUE (Tired). On 18-May-2021, the patient experienced NASOPHARYNGITIS (Very Cold), CHILLS (Chills) and PYREXIA (Fever 100.4 F). On an unknown date, the patient experienced TREMOR (I was shaking), RESPIRATORY RATE INCREASED (my breathing was fast), DYSSTASIA (I was unable to stand), HEART RATE INCREASED (my heart rate was extremely high 115 to 120), HYPERTENSION (my blood pressure was high), BLOOD URINE PRESENT (I was peeing straight blood) and SOMNOLENCE (really sleepy). The patient was treated with IBUPROFEN (ADVIL 12 HOUR) for Tiredness, at a dose of 1 dosage form and PARACETAMOL (TYLENOL) for Body temperature, at a dose of 1 dosage form. On 16-May-2021, LETHARGY (Lethargic), ASTHENIA (Low energy), HEADACHE (Headache) and FATIGUE (Tired) had resolved, MYALGIA (Mild Body Ache, Body aches) had not resolved. At the time of the report, NASOPHARYNGITIS (Very Cold), TREMOR (I was shaking), RESPIRATORY RATE INCREASED (my breathing was fast), DYSSTASIA (I was unable to stand), HEART RATE INCREASED (my heart rate was extremely high 115 to 120), HYPERTENSION (my blood pressure was high), BLOOD URINE PRESENT (I was peeing straight blood), SOMNOLENCE (really sleepy), CHILLS (Chills) and PYREXIA (Fever 100.4 F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: normal (normal) blood pressure expected to be high but it was normal. On an unknown date, Body temperature: 103.5 (High) temperature was high. On an unknown date, Electrocardiogram: 115-120 (High) heart rate was extremely high. On an unknown date, X-ray: unknown (Inconclusive) unknown.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The concomitant medications were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jun-2021: Follow up received on 21-Jun-2021 as reporter, new events and treatment details were added
Patient developed red, welt-like area around injection site on left forearm that faded by the evening of the day of vaccination (05/16/2023). Patient woke up 05/17/2023 and saw that area surrounding injection site on left forearm was red and welt-like again; no itching or pain.  On 05/17/2023, he also developed a red bump closer to the antecubital fossa on media aspect of left forearm. On 05/18/2023, patient developed 3 more smaller, red bumps on right upper arm and on the morning of 05/19/2023, he noticed 3-4 similar bumps on forehead. Bumps are itchy and started out as red bumps that then welted up and then turned in small white pustules. He went to a hospital emergency department out of state and was told the lesions were due to a mild case of  mpox associated with the vaccine! (I informed him this was not possible.) These lesions started to improve on about 05/20/2023 or 05/21/2023, such that by the time I saw them on 05/23/2023, they were less erythematous, smaller, and mainly non-pustular. Lesions were not well-circumscribed, umbilicated, or deep-seated. Patient had no identifiable risks for mpox exposure in the prior month plus. No associated flu-like symptoms, no fever, no LAD.  Therefore, they were not tested for mpox. No other known contacts with same. H/o varicella as child.
Pfizer on 3/10 and 3/31. Positive on 8/30 admitted 9/6 to current
16hrs after Immn, baby had fever of 106 axillary (reported by mom) continued to have temp up to 102-103 next 36hrs. Still has low grade fever.
Vaccine expiration date was 03/01/2023.  Vaccine was administered after expiration date.  Given on 03/03/2023.
Chills, low grade fever, runny nose, body aches, brain fog, mild headache, fatigue that lasted at least 24 hours.  Brain fog lasted approximately 5 days.
This initial spontaneous case, was received on 26-Sep-2017, from other health professional (nurse), concerning a 3-year-old male child. The concomitant medications of the patient included unspecified multivitamins and minerals. The patient had no relevant medical history. On 25-Sep-2017, the patient was administered with FLUCELVAX QIV (batch number: 195226A, expiry date: Apr-2018, dose: 0.5 ml, route of administration, anatomical location: not reported). It was reported that, the vaccine was inadvertently administered to a person under 4 years of age. No other adverse event was reported. The reporter assessed the events as non-serious. Significant case correction was received with IRD 26-Sep-2017: The event 'no adverse event' was removed.
Fatigue, extended arm pain, dizziness, blurred vision, feeling feverish, nauseous, internal organ pain, shaking
continue dizziness  after eat and very disoriented to the point that I can not driver, I feel depress and sad, before the second doses  I was feeling perfectly happy, I have no reason to feel that.
No adverse effects reported.; Nurse reports the administration of one dose of an improperly stored vaccine, ROTATEQ, to one patient; This spontaneous report was received from a Registered Nurse referring to an unspecified patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported.  On 16-SEP-2019, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ) per oral route with lot # R030924 and expiration date 10-JUL-2020  for prophylaxis.   The administered dose of vaccine experienced the temperature excursion of (0.24 °C) (multiple) degrees Celsius for 5 hours and 30 min. There was a digital data logger invloved, but there was no previous temperature excursion. No adverse effects were reported.
Swelling of ankles; Swelling of feet/Swelling of lower legs; This spontaneous case was reported by a consumer and describes the occurrence of JOINT SWELLING (Swelling of ankles) and PERIPHERAL SWELLING (Swelling of feet/Swelling of lower legs) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history information provided by the reporter.  Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID], CLOPIDOGREL BISULFATE (PLAVIX), AMIODARONE, AMLODIPINE, CARVEDILOL, HYDROXYCHLOROQUINE, LORAZEPAM and EZETIMIBE (ZETIA) for an unknown indication.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced JOINT SWELLING (Swelling of ankles) and PERIPHERAL SWELLING (Swelling of feet/Swelling of lower legs). At the time of the report, JOINT SWELLING (Swelling of ankles) and PERIPHERAL SWELLING (Swelling of feet/Swelling of lower legs) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient did not receive any treatment for the symptoms. His symptoms are  ongoing and were getting worse even after 4 days.
Extreme nausea and vomiting, with migraine, lasting 38 hours after the vaccine was administered. Took Dramamine to help with nausea, but continued dry heaving for the next 2 days.
Received pneumonia vaccine on 10/27/09. On 10/29/09 reported redness which extended down the R arm & worsened as the day went on. To the ER on 10/29/09 - IV antibiotics, F/U with Dr. on 11/02/09. No residual symptoms.
2 HOURS AFTER INJECTION REPORTED SLIGHT HEADACHE, HEAVY CHEST, SORE ARM FOR APPROX 24 HOURS
Chills, 01:00 am  102 temperate  and head ache and chills. Next day had head ache and  fatigue  diarrhea for 36 hours  and got tested for 12/28/2020 Tested for COVID -19 was negative.
Right upper arm warm to touch, swollen, and red. It was itchy x 2 days, that has resolved. Area has moved towards R elbow. Denies SOB, fever. Has been taking BENADRYL at night and icing it w/ good effect. Does feel a little under the weather but denies fever, congestion, malaise.
Cough, congestion, shortness of breath, diaphoretic, Temp of 99 degrees F, nausea, oxygen saturation dropped to 88% on room air
Headache, Myalgia, Fever, UrticariaPruritus, FATIGUE, "TREMORS" ON 3rd DAY Narrative:
pt mom states child had hep B vax rxn n/v & inc fever x 4 days;child peds suggested not to have 2nd HBV vax;
"Rash all over and itching, not feeling well." Benadryl 25mg IM, home with 25mg po q 8 hours x 24 hours. Solumedrol 35mg, IM, home with 60mg prednisone x3 days.
liver enzymes elevated; This is a spontaneous report from a contactable Pharmacist(patient)  A 49-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EP7533), via an unspecified route of administration on 06Apr2021 (at 49 years) as single dose for covid-19 immunisation. The patient medical history was not reported. Concomitant included tumeric supplement  (ingredients were reported as tumeric 150,tumeric extract 130,carrot 50mg,ginger root 20mg and black pepper fruit extract 5 mg) at 150mg one a day  . Patient received the first dose of the vaccine (lot EP7534) on 14Mar2021 (at 49 years) in left arm for covid-19 immunisation. The patient experienced liver enzymes elevated on 11Aug2021.  The patient underwent lab tests on 11Aug2021  which showed alanine aminotransferase (ALT) increased at 63 IU/L and aspartate aminotransferase (AST) increased at 42 IU/L.  Outcome of the events was not recovered.
After receiving vaccine, approximately 15 minutes, the patient experienced loss of movement in left leg and drooping of the right side of face. We called 911 and the emergency team took her to hospital in ambulance.
Pt recv vax on 11/3/97; on 11/04/97 pt exp vax site rx of redness & pain
My child began feeling tired and ran a temperature about a degree warmer than usual for the first three days after his second COVID vaccine on Sunday 13 June. (So Monday, Tuesday, Wednesday). Thursday he was extra tired and began to complain of itching under the chin in the evening. Friday morning he woke up and had what he described as itchy/painful raised, red patches of skin on his right collarbone, under his chin, across his face (right cheek, temple). His temperature was about 100* and he was, quite frankly, pretty miserable. These weren't little skin irritations, they were giant patches of inflamed tissue covering the better part of each cheek, his temple, under the chin and then in smaller spots on his collarbones and back. Saturday the rash moved to cover the left side of his face, and the left collarbone. (And no, for the record, I did not switch laundry detergents, change his diet or anything like that.) As of today, 6/21 condition has improved but not fully resolved.
arm was so sore she could not lift it; fatigue; stomach issues; general unwell feeling; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was so sore she could not lift it), FATIGUE (fatigue), ABDOMINAL DISCOMFORT (stomach issues) and MALAISE (general unwell feeling) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced PAIN IN EXTREMITY (arm was so sore she could not lift it), FATIGUE (fatigue), ABDOMINAL DISCOMFORT (stomach issues) and MALAISE (general unwell feeling). In March 2021, PAIN IN EXTREMITY (arm was so sore she could not lift it) outcome was unknown. At the time of the report, FATIGUE (fatigue), ABDOMINAL DISCOMFORT (stomach issues) and MALAISE (general unwell feeling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. The treatment information was unknown.
Pt developed SOB, facial swelling, throat swelling, and extremity swelling within 1 hr of receiving the vaccine on 12/17/22. Pt was given epinephrine on way to hospital - transported by pt's mother. In ER, pt was given steroids IV + IV Fluids. Pt was discharged after observation. On 12/18/22, pt's SOB and angioedema worsened. She was taken to ER. She was given steroids IV + epinephrine + IVF. She was admitted to the hospital and is currently in the transitional unit. She has received epinephrine a 3rd time and is getting SoluCortef, Prednisolone, Benadryl IV, Pepcid IV, and Zyrtec PO.
RASH ON TRUNK, NO HIVES, NO PUSTULES/NO WEEPING,
5 days after receiving vaccines, he had left upper extremity swelling, redness, and warmth. His left thumb base was itching. There was left thumb pain with motion. Today, he noted right 4th finger tip being hard.  6/2/09 ED and inpatient hospital records received DOS 5/19/09 to 5/21/09. FINAL DIAGNOSIS: Hypertension, hand cellulitis. Post vaccination presented with swelling in left arm, erythema. Itching and bruising of left thumb, painful on motion, pain at base of thumb. Erythema, swelling, and purplish discoloration of right middle finger. Pain and swelling of left knee. Purulent area, with erythema at site of smallpox vaccine on right biceps. Infectious disease consult notes whitish pustule on right arm.  ICD-9 Codes: 682.4 Cellulitis/Abcess Hand Exc Finger/Thumb, 401.9 Hypertension NOS.
Patient went home asymptomatic 15 minutes after receiving the vaccine. She returned to the vaccination center 30 minutes later with complaints of repeated loose to watery bowel movements. Upon arrival she appeared pale and complained of dizziness and of being  nauseated. No vomiting occurred but she was retching and burping loudly. After arriving to the center she had one more episode of diarrhea. She was afebrile, pale, had a strong regular pulse, a regular heart rhythm, clear bilateral breath sounds and complained of feeling dizzy. No abdominal pain.
Fever of 100.8 degrees for more than 12 hours, less than 24 hours. Body ache (6 out of 10 scale) for more than 12 hours, less than 24 hours. Treated initially with ADVIL (1 dose)/no beneficial effect. Treated with aspirin (1 dose/325 mg) - relief sufficient to be comfortable/sleep.
Severe headaches, sweats/chills, diarrhea and fatigue Symptoms began 9/16-not much improvement
PATIENT STARTED TO HAVE RIGHT JAW FACIAL PAIN THAT RADIATED PAIN AND CHANGED LOCATIONS. FORWARD AND THEN BACKWARD  MOVEMENT, ALONG THE SIDE OF THE EAR AND PAIN CONTINUED TO RIGHT CHEEK, SLIGHTLY CHANGING PLACES. DENTIST BELIEVES THIS IS A SINUS PROBLEM BUT IT FEELS LIKE PAIN. ONGOING SINUS INFECTION
Pfizer-BioNTech COVID-19 Vaccine EUA: patient reported lightheadedness, palpitations, lower abdominal pain (menstrual cramps), and tachycardia after receriving vaccine and not having any oral intake that day prior to vaccination. Denies shortness of breath, chest pain, nausea, vomiting, and diarrhea. Transported to the emergency department (ED) where vital signs were within normal ranges except for blood pressure 152/108. Patient was offered and able to tolerate food and drink by nouth, observed, symptoms improved, and discharged to home stable.
while being held pt had episode of going limp & unresponsive & turning white/pale; lasted several mins thens resolved;
Shingles, first started estimated 5/7 and diagnosed 5/10. Finished antiviral medication 5/18, condition ongoing. Rashes on right side - chest, under arm, upper arm, shoulder blade.
This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 69-year-old female patient who received SHINGRIX (batch number 3Z4KL, expiry date unknown). On 6th February 2018, the patient received the 1st dose of SHINGRIX. On 7th February 2018, 1 days after receiving SHINGRIX, the patient experienced fever, swollen tongue, swollen mouth and pruritus. On 8th February 2018, the patient experienced rash. On an unknown date, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the fever, swollen tongue, swollen mouth, pruritus and rash were recovered/resolved and the outcome of the influenza-like symptoms was unknown. The reporter considered the fever, swollen tongue, swollen mouth, pruritus and rash to be almost certainly related to SHINGRIX. It was unknown if the reporter considered the influenza-like symptoms to be related to SHINGRIX. Additional details were reported as follows: Two days after receiving SHINGRIX, the patient experienced a rash which went down her arm. Less than a year after receiving SHINGRIX, the patient experienced flu-like symptoms. The patient required to visit emergency room.
Pt. states sweling occurred at administration site that went from deltoid to elbow pt states arm was painful and hot to touch. She took BENADRYL and used ice packs on her arm. She also took ibuprofen at the advice school nurse. Symptomology lasted at 4 days. She did not go to MD but is worried at long term effects. She states ache in her arm still and she had dizziness the friday following shot.
Patient brought in the ED by EMS on 12/6/22 for difficulty breathing. Prior to being seen in the ED, EMS gave the patient 1 duo neb but she still had wheezing and increased work of breathing so was started on CPAP. In the ED, she also reported a cough. COVID PCR test was done in the ED and returned positive. She was admitted 12/6/22 - 12/8/22 for acute hypoxic and hypercarbic respiratory failure, COVID-19 infection, acute exacerbation of severe COPD, acute exacerbation of severe LV systolic CHF, among other discharge diagnoses. During admission, she initially required BiPAP but was able to be weaned to room air. Patient has received the COVID primary vaccine series and one booster.
Pregnant participant was vaccinated with Influenza vaccine, Fluvirin Novartis.