chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) in a 35-year-old male 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 9:23 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Apr-2021 at 9:23 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 35.66.  Concomitant products were not provided.  On 03-Apr-2021, Excursion time was 09 AM, temperature was 34, total doses given for the day was 210, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 30-Mar-2021, vial was moved to clinic on 03-Apr-2021. 20 vials were sent to clinic. Vaccine BUD date was 29-Apr-2021.  On 03-Apr-2021, vials were stored in cooler 1, at following time and temperature respectively, 8 AM: 38, 9 AM: 34, 10 AM: 38, 11 AM: 42, 12 PM: 41, 1PM: 41, 2 PM: 41, 3 PM: 40, 4 PM: 40 and 5 PM: 41.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
Pfizer Ped 5-11 Lot# FL2757 was to be removed per notice on 10/12/2022. Pharmacist gave a dose of the vaccine to be removed due to expiration date early morning on the 12th before the removal  notice came through . Pfizer indicated on 10/25/2022 that the stability of the vaccine supports the use of the product through 10/19/2022. No further action is needed and patient not to be revaccinated nor notification required.
Arm was real sore; Experienced a 4 inch red area around the injection site; Hard lump around the injection site; Arm was itchy; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was real sore), VACCINATION SITE ERYTHEMA (Experienced a 4 inch red area around the injection site), INJECTION SITE INDURATION (Hard lump around the injection site) and PRURITUS (Arm was itchy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm was real sore), VACCINATION SITE ERYTHEMA (Experienced a 4 inch red area around the injection site), INJECTION SITE INDURATION (Hard lump around the injection site) and PRURITUS (Arm was itchy). The patient was treated with Ibuprofen at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Arm was real sore), VACCINATION SITE ERYTHEMA (Experienced a 4 inch red area around the injection site), INJECTION SITE INDURATION (Hard lump around the injection site) and PRURITUS (Arm was itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.
2:15 pm client exhibited a well red mark under her chin area, neck area approximately 4 inches X 1 inch diameter well # 2 approximately 6 inches X 2 inches in diameter just below red area #1.  Client complaints or exhibits no other signs or symptoms @ 2:30pm.  Client c/o tingling to her upper lip.  No swelling noted.  V/s 98.9, P87, R20, B/P 134/86.
Pt is 20 yo male with 1 wk progressive weakness in LE's and 2 hx of facial weakness. Weakness is asymmetric, prox > distal. Decreased reflexes throughout. Reports received vaccine at work 1 month ago. Diagnosis GBS. 12/11/08-numbness in fingers and toes began on 1/26/08 then legs achy, leg weakness gait changes.Left Face drooping and twitches. Slurred speech, voice changes, taste different. Unable to perform activities of daily living. Decreased strength and coordination. Areflexia, ascending weaknesses.  Moderate dysarthria. Increased time to masticate foods. Treated with IVIG. Bloodpressure elevated. Asymptomatic parasympathetic dysregulation possibly a cysautonomia in cortex of GBS. Sinus pauses with labile BP/HR.
Headache, Myalgia, Fever, CHILLS Narrative:  Other Relevant History:
This child had large local redness, and swelling at the site of the injection 4" x 3".
Intense itching all over body. Noticed vesicular rash to upper arms, flank,thighs, posterior knees.
Redness, swelling of injection site, fever 101.9, soreness and tenderness of Left upper extremity. Was getting better by f/u appt on 11/02/10 Keflex given.
Pt received her first moderna covid 19 vaccine on 3/2/2021. She never went for her second dose as she feels she went downhill since. Pt has no significant medical problems  other than chronic, mild normocytic anemia, alopecia and vit D deficiency and was on no medications prior other than vitamin D prior to admission. She considered herself active and healthy. After her vaccination she was diagnosed with 2 urinary tract infections and  she also began having poor appetite and abdominal complaints which continued to progress to the point she presented to our emergency room  on 7/25/21 after sustaining an over 20lb weight loss with complaints of poor appetite, abdominal pain, significant nausea, shaking chills, fever, blood in her stool and severe fatigue. She was also recently diagnosed with 2 urinary tract infections of which she has never had before in her life recently treated with bactrim and then ciprofloxacin antibiotics. She was admitted to the hospital with severe sepsis with wbc of 27,000 with left shift, thrombocytosis with platelets of 616,000, colitis, dehydration, metabolic encephalopathy, malnutrtition and acute kidney injury. CT of the abdomen and pelvis revealed colitis of the proximal and mid sigmoid colon. Her hospital course was protracted with initially persistent fever and sign nausea and severe fatigue. she ultimately underwent sigmoidoscopy with gastroenterology which revealed ulcerative colitis.  She was started on iv steroids and ultimately discharged home on oral steroids and rectal steroids and antibiotics to follow up with GI as out pt. she was seen throughout her hospital course by GI, general surgery and infectious disease. she denies prior hx of covid 19. she was discharged home on 8/1/21. her wbc on discharge was 10..1 but she continues to have neutrophilia and lymphopenia.
Fever 100; Chills; A spontaneous report was received from a Non-Health Professional concerning a male patient, of unknown age, who was administered Moderna's COVID-19 vaccine on 22-DEC-2020 and experienced fever 100 and chills.  The patient's medical history was not reported. No relevant concomitant medications were reported.  The patient received his first of two planned doses of mRNA-1273 (Batch number: unknown) for prophylaxis of COVID-19 infection on 22-DEC-2020.   The patient experienced fever 100 and chills on 08-JAN-2021. The treatment history was not reported.  The action taken for Moderna COVID-19 vaccine was unknown. The outcome of the events, which were fever 100 and chills was unknown.  The Non-Health Professional did not declared any relatedness between the events, fever 100 and chills and  the Moderna COVID-19 vaccine.; 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. Further information has been requested
Pt vacc. /w Attenuvax on 22Jun90. 3 hrs /p vacc. pt developed a transient ischemic attack (TIA) manifested principally by slurred speech which persisted for 10-15 min before remitting spontaneously. More info. requested
Leg weakness & severe muscle spasms & mild leg paralysis leading to severe leg pain & several falls one resulting in fall onto concrete causing injuries & one causing a broken right arm
Pt. given DTaP instead of Tdap. No adverse reaction reported. RN tried to contact parents with info, but got no answer. Family was traveling.
Syncope and collapse - ED visit to hospital admission. This visit was within 6 weeks of receiving the COVID-19 vaccine.
This spontaneous report was received from a pharmacist via a company representative and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions, allergies and concomitant therapies was provided. On unknown dates, the patient was vaccinated with a doses of PNEUMOVAX 23 on a yearly basis (dose, route of administration, lot # and expiry date were not reported). No adverse effects were reported.
7 pm fever 102-103 deg . Congestion. Tylenol. 2 day to Dr. for anti. Was on Bioxin since H8-01 taking last dose day of immunization. Appeared well with no fever at time. About 7 pm 1-26-01 fever started. 102-103 degrees with return of congestion. Jan 29-01 returned to family Dr. Was put on Zefzil 125mgm. Has repeated ear infections. Family Dr. told mother it was due to immunizations.
Patient is a diabetic and currently using insulin pump.  After getting her Pfizer bivalent booster vaccine at 5:00pm he experienced high blood sugar level of 200 at bedtime.  She stated the previous night her blood sugar was at 97.
4 days following vax devel malaise @ work;chills&fever followed&left work & went to bed;following day, rhinitis & repetitive sneezing ensued;2nd day asthma like difficulties & sinusitis developed;progressed to brochials 3rd & 4th days
Patient reported feeling dizzy after the shot once he was sitting down in the waiting room for his observation period. Pharmacist went over to patient, he reported feeling more and more light headed and passed out. He remained upright in the chair and still was breathing with pulse. EMS was called at this time. He came to after about 10-15 seconds and was initially confused but easily reoriented. Got patient water and stayed with him in the chair until EMS arrived. EMS evaluated and took vitals. Recommended patient go to ER. Patient declined ride in ambulance. Patient's mother came about 20 minutes later to pick him up and drive him to the hospital. Pharmacist walked patient and mother out to parking lot and observ
Left arm soreness; Uncomfortable; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 50-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd March 2020, the patient received the 1st dose of Shingrix. On 3rd March 2020, couple of hours after receiving Shingrix, the patient experienced pain in arm and arm discomfort. On an unknown date, the outcome of the pain in arm and arm discomfort were recovered/resolved.   It was unknown if the reporter considered the pain in arm and arm discomfort to be related to Shingrix.  Additional case details were reported as follows: The patient received Shingrix and experienced left arm soreness within a couple of hours after receiving the injection. It was uncomfortable more than an average vaccination and it took about 4-5 days to resolve.   The reporter consented to follow up. For tolerances of 2nd dose, refer case US2020090247, reported by same reporter for the same patient.
5/16/05 Mother reported that 5/13/05 in the afternoon pt had "runny nose and eyes", 5/13/05 in the evening he had some trouble with breathing and by 5/14/05 in the evening he had a temperature of 102.4 and more difficulty with breathing when he was taken to the ER.  Neck and chest x-rays negative.  ER informed her symptoms were an allergic reaction to vaccine and child given epinephrine and steroid with improvement in symptomes and sent home. 5/16/05 symptoms are only a "runny nose" and lower than normal energy.  Family MD saw pt today and suggested cold unrelated.
Headache, Arthralgia, NauseaVomiting, Palpitations, HYPERtension, fatigue, lymphadenopathy, light-headed, flush Narrative: Took OTC excedrin and tylenol 13:56 had palpitations, HTN 14:00 had palipiations, HTN, flush, HA, arthralgia, fatigue, nausea, lymphadenopathy, lightheaded
2 children-February 16th 2019 5 lbs 9 oz, March 22nd 2021. Horrible body aches and chills. 9 am. Wednesday January 27th, lasted til 11 pm
On 8/3/01 the pt experienced redness at the injection site, 1.5 x 2 cm in diameter. On an unspecified date, the pt recovered. Another pt (WAES00092216) had a similar experience following exposure to MMRII. No further info is available.
1 week post vax, the pt experienced lethargy, anorexia, vomiting, rash on face and extremities and a 3 mm papular erythematous area.
Patient wanted Janssen vaccine but received Pfizer. He was informed of mistake and agreed to return for second dose in 21 days.
Feels that he is experiencing symptoms of self diagnosed ZSH; Self diagnosed ZSH; Abdominal pain where his shirt rubs against his belly; Hard for him to sleep; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 63-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included gas (has been seen by the Gastrointestinal specialist). Concomitant products included pregabalin (Lyrica).   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, more than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), herpes zoster, abdominal pain and trouble falling asleep. On an unknown date, the outcome of the vaccination failure, herpes zoster, abdominal pain and trouble falling asleep were unknown.   It was unknown if the reporter considered the vaccination failure, herpes zoster, abdominal pain and trouble falling asleep to be related to Shingrix. It was unknown if the reporter considered the vaccination failure and herpes zoster to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received both the Shingrix shots 3 years prior to the report but 6 weeks ago sought medical care for abdominal pain where his shirt rubs against his belly. This made it hard for him to sleep. The patient has also been seen by the neurologist who prescribed Lyrica 75 mg Bid. The patient felt that he was experiencing symptoms of self diagnosed ZSH (zoster sine herpete). The reporter did not consent to follow up.
Narrative: Patient contacted call center 10 days after receipt of Moderna booster (patient received full 3rd dose as they are immunocompromised). Reports he had chills, fever up to 100.3, vomiting, dizziness, weakness, diarrhea. subsequent to receipt of the Vaccine (unclear when onset of symptoms occurred)
Information has been received from a nurse practitioner concerning a newborn (1 day old) white female, with no allergies, pertinent medical history or concomitant medications, who prior to her discharge from the hospital on 07-OCT-2007, was vaccinated with RECOMBIVAX HB (lot# 654744/0771F). It was reported that thirty minutes after the vaccination, at home, the mother of the newborn noticed she had developed a rash on her back, chest, and legs. It was reported that the newborn also seemed lethargic and was coughing. The mother brought the newborn back to the hospital where she was seen by the attending physician who indicated that the symptoms may have been related to newborn acne. The rash resolved on 09-OCT-2007. No product quality complaint was reported. NO further information was available. Follow up information received from the nurse practitioner reported that 30 minutes after the vaccine was given, red bumps that looked like fire ants bites developed on the legs, back, and stomach, seemed lethargic, and as if phlegm was in the throat. The patient feed poorly that day. It was reported that the rash lasted for two days and that the patient as of 08-OCT-2007 had recovered. Additional information has been requested.
Notices tenderness after shot AM 8/29 Really not feeling good. Red & hot at the site about a dollar size area told to take TYLENOL & cold pack by doctor There was a fever 8/29 but gone on 8/30 and has been gradually better since.
I started feeling weird pulse rate went up and vertigo, nausea. Took blood pressure at home 175/100 awhen  I called 24 hr nurse line she recommend to go to the ER. I went to ER.  They did a EKG. Nothing alarming came up. Brought me back and put me on IV and anti nausea medication and anti vertigo medication. They didn't thing that it had to do anything with vaccine. Heart rate went down. They told me to go home at 5am but I was still feeling Nausea and dizzy. Had Vertigo for several days. My pulse and heart rate went down, but still have vertigo every now and then.
Information has been received from a physician concerning a female who on approximately 13-SEP-2007 was vaccinated with Gardasil (Lot # not reported). Subsequently post vaccination the patient fainted. Subsequently, the patient recovered after about 20 minutes. Unspecified medical attention was sought. Additional information has been requested.
This spontaneous report was received from a nurse practitioner and refers to a unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided. On 13-APR-2017, the patient was vaccinated with improperly stored doses of VARIVAX subcutaneously, lot# reported as M043582 with an expiration date 28-OCT-2018, lot#M041079 with an expiration date 06-ACT-2018 and lot# M042495 with an expiration date 19-OCT-2018 for prophylaxis (dose was not reported). The VARIVAX was reconstituted with properly stored sterile diluent (STERILE DILUENT) (doses, route of administration, lot# and expiration date were not reported). No side effect was reported.  Administered doses of VARIVAX experienced temperature excursion of 25.5 degrees Fahrenheit for 1 hour and 48 minutes. There was no previous temperature excursions. A digital data logger was involved. Product quality complaint (PQC) was not involved. Additional information has been requested.
Redness and soreness w/ lump at vaccination side starting day 1-3, lump remained at vaccine site with fussiness and irritability in infant on 8/13/2020 prompting a re-evaluation in clinic
Day 1 fine. Day 2:arm soreness. Day 3 chills, muscle aches, extreme fatigue, headache, swollen glands. (Took Chinese medicine herbs for immune support and day 4 better with zero symptoms remaining ).
BlurredVision, Myalgia, Fever, pt reported fever, chill, aches, headache, fatigue, sweats, rt eye vision issues on day 1 and 2. Narrative: Pt reported fever, chills, aches, headache, fatigue, sweats, and rt eye vision issues on day one lasting into day 2. She took ibuprofen for her symptoms.
Pt recvd immun on 3May91,@time of 4mo well baby checkup.Pt was seen in ER on 7May91 @ 630am in cardiac & respiratory arrest as an apparent SIDS death & pronounced dead /p CPR attempts.
Complainant reports that last Monday 19AUG91 husband recvd Pneumonia prevention shot; a day later, pt exp a rxn of being very irritable & having a broken rib feeling, pleurisy; Hospitalized 4 days; MD felt was serum rxn;
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, 3 hrs after receiving SHINGRIX, the patient experienced injection site pain and injection site lump. On an unknown date, the outcome of the injection site pain and injection site lump were recovered/resolved. It was unknown if the reporter considered the injection site pain and injection site lump to be related to SHINGRIX. Additional details were provided as follows: The case was reported by the wife of the patient. The age at vaccination was not reported. The patient received SHINGRIX vaccine on left arm. The patient experienced soreness in left arm. The soreness presented in his left arm 3 to 4 hours after receiving the injection. The patient described the injection as feeling like lump of liquid was injected. The soreness lasted for approximately one week. The reporter did not consent to follow-up.
got very sick; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown.   The reporter considered the sickness to be related to Shingles vaccine.  Additional details provided were as follows: The case was reported for reporter's brother in-law. The age at vaccination was not reported. The patient received a dose of Shingles vaccine and got very sick from the vaccine. Follow-up would not be possible as no contact details provided.
Fever, chills, dizziness, muscle aches, leg cramps, weakness, (flu-like symptoms) lasted approx 36 hours
This spontaneous report was received from a physician and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and allergies were not reported. On an unknown date, the patient was vaccinated with a dose of GARDASIL, (strength, dose, frequency, route, anatomical location, lot number and expiration date were not reported). Other suspect and concomitant therapies were not reported. On an unknown date, the patient experienced mononucleosis after receiving GARDASIL. The outcome of mononucleosis was unknown. The relatedness between mononucleosis and therapy with GARDASIL was not reported. This is one of two reports received from the same reporter. Additional information has been requested.
itching, redness, swelling at injection site  Narrative:  Other Relevant History:
Had large skin reaction 3" x 3 1/2"  one days post DTaP with 102 deg. f. which responded to Advil.
pt recvd vax; devel redness, warmth & induration  at inject site
Patient experienced a vasovegal episode  ~7 hrs after vaccination. She stated she did not feel well and sat down immediately. Coworkers called for help and nursing within the healthcare facility she worked at came to help.  Nursing placed her oxygen as clinic protocol, BP was low. No meds given and patient was feeling better in just a few minutes.  Patient left facility a short time later with spouse. F/U last night by vaccinator and this morning. Patient has had no more episodes. She is having expected mild side effects, low grade fever, chills, fatigue.