chrisvoncsefalvay/vaers-outcomes huggingface dataset:
nurse who reported MENQUADFI underwent temperature excursion with low temperature of 0.5 degrees C with no reported adverse event; nurse who reported MENQUADFI underwent temperature excursion with low temperature of 0.5 degrees C and was administered with no reported adverse event; Initial information received on 18-May-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 18 years old and unknown gender patient who had nurse who reported menquadfi underwent temperature excursion with low temperature of 0.5 degrees c and was administered with no reported adverse event after receiving vaccine meningococcal a-c-y-w135 (t conj) vaccine [menquadfi].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 15-May-2023, the patient received a dose 2, 0.5 ml of suspect meningococcal a-c-y-w135 (t conj) vaccine Solution for injection lot U7576AB, 28-FEB-2025 via intramuscular route in the left arm for Immunization.  On 15-May-2023 the patient developed a non-serious event nurse who reported menquadfi underwent temperature excursion with low temperature of 0.5 degrees c and was administered with no reported adverse event (poor quality product administered) (latency: same day). On an unknown date the patient developed a non-serious nurse who reported menquadfi underwent temperature excursion with low temperature of 0.5 degrees c with no reported adverse event (product storage error) (unknown latency).  Action taken was not applicable.  Outcome: Unknown for both the 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 guidelines. 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.
Patient called reporting that her arm is hurting her. She has to physically pick up her arm to reach things and it is just causing her pain.
Patient developed an erythematous macular rash around injection site on right thigh measuring 4cm x 4 cm with associated leg pain, & slight swelling, which is resolving upon seeing him 2 days later.
Pt. developed gradually increasing swelling, redness and heat over 6 hours with response to icing & XYZAL (antihistamine).
felt fine day of vaccination. slept poorly that night and awoke not feeling well (typical flu ;like symptoms).  got up at 6am and fainted on bathroom floor.  fainted again few minutes later.  Bruised & sore from crashing down 2X.  Felt better next day, except for bruises.
pt says that her right arm became very sore.  The muscles in her right knee became sore.  Her knee seemed to have locked up.  By the next day it became very painful and still.  The pain is going up towards the thigh and then going down the calf muscle.  Pt has taken Advil and used ice compressions for the pain.  She says the pain and swelling seem to be less present today but is still there and will see an orthopedic doctor if she doesn't improve.
Patient received routine vaccines at 15 month visit as listed above. Approximately 3 months later, in Feb 2020, parents noted several lumps in R thigh where shots had been given. U/S showed nonspecific hypoechoic nodules. Biopsy showed dermal granulomous inflammation around necrobiotic debris. Pt had testing through the allergist and was strongly reactive to aluminum. Allergist believes the nodules may represent a delayed hypersensitivity reaction to aluminum. Patient also subsequently developed similar nodules in L thigh in the area where the other shots listed above were given at the 15 month visit.
Approximately 1 month after vaccination. Symptoms have been mild and variable and seem worse at night. Headache, runny nose, fatigue, achy, minor chest congestion, and cold like symptoms.
About 10 minutes after injection, c/o tachycardia and became diaphoretic and stated she felt "weird"  Taken to ER for eval/tx.
dizzy; Full body rash; This is a spontaneous report from a contactable consumer reported for a male patient. A male patient of unspecified age received first dose of bnt162b2 (Pfizer covid-19 vaccine, Solution for injection, Batch/lot number: Unknown, Expiry date: Unknown), via an unspecified route on 13Feb2021, as a single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. Co-suspect medication included diphenhydramine hydrochloride (BENADRYL) on 13Feb2021. On 14Feb2021 after 24hours of covid shot, patient developed a rash, like a full body rash. He didn't get it immediately after the vaccine, he got it now 24 hours into it. Reporter gave him some Benadryl and he seems to be okay with the Benadryl but he's gotten very dizzy, he is kind of like almost tripped little dizzy. He says he feels fine. Reporter was wondering if that is something common or should she take him to the emergency room should we sit it out with the Benadryl to see if it gets better with that. The clinical outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Patient was supposed to get his first dose of the original pediatric Pfizer covid vaccine but the bivalent Pfizer covid vaccine was administered. Patient experience no side effects at the time of administration.
Administered  above vaccine past the 75days of storage in the fridge to 25 days past BUD. I'm calling all 55 patients to let them know their options.
5ml syringes that had been provided by Health Authority were used to draw up diluent for mixing the 5-11 year old Pfizer COVID-19 vaccine vial on 12/16/21.  Diluent drawn up and injected into the vaccine vial was 1.6ml rather than 1.3ml.  Diluent was measured on the 5ml syringes incorrectly:  Counting each mark as 0.1 rather than 0.2ml.  This resulted in the vial being mixed with 0.3ml extra diluent.  Vial had a bonus dose (so 11 doses total).  Patient was given a vaccine dose at 90% of the correct concentration.  Error has been reported to Pfizer.  Families are currently being contacted by letter and by phone to be alerted of the error and offered a re-dose if they would like this.  No adverse effects to patients have been reported.
Headache, Myalgia, Arthralgia, Angioedema, SkinRash, UrticariaPruritus & Purpura Narrative:
given shots during excursions; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (given shots during excursions) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 27-Oct-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (given shots during excursions). On 27-Oct-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (given shots during excursions) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication information was provided. No treatment information was provided.
absence of menses for prolonged durations / pre-menses experience of debilitating nausea  & headaches
Headache, dizziness; Patient rested and took Tylenol and got better by 2PM oon 5/27
Red, hot,  itchy rash  along injection site, exactly 1 week after first vaccine
CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient via other company (Pfizer) concerned a 61 year old male. Initial information was processed along with the additional information received on 29-JUN-2022. The patient's height, and weight were not reported. The patient's concurrent conditions included: allergy. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 042A21A, and expiry: UNKNOWN) dose was not reported, 1 in total was administered on 01-APR-2021 to left arm for prophylactic vaccination. Age at time of vaccination 60 years old. Concomitant medications included levothyroxine.  The patient additionally received non-company suspect vaccine tozinameran (Pfizer vaccine) (dose number in series 2) (form of admin, route of admin were not reported, batch number: 3198, expiry: UNKNOWN) dose was not reported, administered on 03-JAN-2022 to left arm for prophylactic vaccination.  On 31-MAY-2022, after suffering from a high fever for 36 hours, the patient tested positive for COVID-19 on 02-JUN-2022 which was coded as confirmed covid-19 infection (dose number in series 2) which led to confirmed clinical vaccination failure (dose number in series 1). On 02-JUN-2022 at morning, the patient received non-company suspect drug Paxlovid (form of admin, route of administration, batch number and expiry were not reported) dose and frequency were not reported administered for covid-19 treatment and completed prescription on 06-JUN-2022. On 06-JUN-2022, after administration of last dose of Paxlovid, the patient felt nearly 100 percent cured, except for some minor wheezing (dose number in series 2). On 10-JUN-2022 14:15, the patient redeveloped a fever (dose number in series 2). On 11-JUN-2022, the patient felt worse as his cough increased in his chest, and his head congestion also increased which was followed by a clogged eustachian tube that past week and fatigue (dose number in series 2). On 17-JUN-2022, the patient again tested positive for Covid. The action taken with covid-19 vaccine ad26.cov2.s, and tozinameran was not applicable. The patient had not recovered from confirmed covid-19 infection, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000238666.; Sender's Comments: V0: 20220658513-covid-19 vaccine ad26.cov2.s-confirmed clinical vaccination failure. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Got very weak and achy, could hardly stand up for the next two days after about 10 after the shot . My hips still ache and never had this problem before
1/11 Tacycardia (136), Fatigue, 101 degree F temp at 3am 1/12 HR 110 Fatigue
redness; major headaches, rated pain as 7 and 1/2; fever; chills; Feeling of being tired/fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (redness), FATIGUE (Feeling of being tired/fatigue), HEADACHE (major headaches, rated pain as 7 and 1/2), PYREXIA (fever) and CHILLS (chills) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, the patient experienced FATIGUE (Feeling of being tired/fatigue). On an unknown date, the patient experienced ERYTHEMA (redness), HEADACHE (major headaches, rated pain as 7 and 1/2), PYREXIA (fever) and CHILLS (chills). The patient was treated with CORTISONE at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, ERYTHEMA (redness), FATIGUE (Feeling of being tired/fatigue), HEADACHE (major headaches, rated pain as 7 and 1/2), PYREXIA (fever) and CHILLS (chills) outcome was unknown.        The action taken with 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.   No relevant concomitant medications reported.
patient received 30 mcg/0.3 mL instead of 10 mcg/0.2 mL
Left ear redness/hot to touch Slight face swelling area of injection sore Treatment - Benadryl
lost sense of taste; lost sense of smell; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (lost sense of taste) and ANOSMIA (lost sense of smell) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced AGEUSIA (lost sense of taste) and ANOSMIA (lost sense of smell). At the time of the report, AGEUSIA (lost sense of taste) and ANOSMIA (lost sense of smell) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication was provided by the reporter. No concomitant medication was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 27-Sep-2021: Follow up received and contains non significant information.; Sender's Comments: This case concerns a female patient of an unknown age with no relevant medical history, who experienced the unexpected non-serious events of anosmia and ageusia. The events occurred at an unknown date after the first dose of Spikevax. The rechallenge was unknown as the events happened after the first dose and no information about the second dose was disclosed. The benefit-risk relationship of Spikevax is not affected by this report.
Patient came in 11/6/13 and stated he's been having burning pain/sensation around injection site. No redness/swelling.
Information has been received from a medical assistant referring to an unspecified patients of unknown ages and genders who on an unknown date, might have received an improperly stored dose of one of the following vaccines (she was not sure which lot the patient received): M-M-R II, (rHA, lot #s N013295, expiry date 28-APR-2019; N009172, expiry date 20-MAR-2019; M040558, expiry date 03-OCT-2018). ROTATEQ, (lot #s N013884, expiry date 05-DEC-2018; N000193, expiry date 20-OCT-2018). PROQUAD, (lot #s N023969, expiry date 19-MAY-2019; N020007, expiry date 13-JAN-2019) or VARIVAX, (lot #s M049125, expiry date 15-DEC-2018; N025931, expiry date 19-SEP-2019). The temperature excursion for the vaccines were of 9°C to 25°C during a time frame of 112 hours (also reported as 44 minutes in refrigerator and 35 minutes in freezer). There were not previous temperature excursions and it was called because of a data logger. No adverse effects were reported. Later the Medical Assistant also update details only for VARIVAX and PROQUAD, she stated that were administered to unspecified patients after being improperly stored. Total time in the range was 9 C to 25 C. Time frame was 112 hours, for this two vaccines no previous temperature excursion was reported and the call because of a data logger as well. All the information regarding the other products remained the same.
This spontaneous report was received from registered nurse, concerning a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies were not provided. On 07-MAR-2014, the patient was vaccinated with a dose of LIQUID PEDVAQXHIB, 0.5 ml intramuscularly, (lot number and expiration date were not provided), which was exposed to a temperature of 47F for 10 minutes. No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Information has been received from a registered nurse concerning a 41 year old female who on 15-JAN-2007 was vaccinated with a dose of Pneumovax 23 vaccine. On 18-JAN-2007, 55 hours after vaccination, the patient developed four raised, inflamed and tender lesions on the inner aspect of her injection site arm. The patient was treated with topical diphenhydramine (BENADRYL), and the lesions flattened. The outcome of the patient's raised, inflamed and tender lesions was unknown. Raised, inflamed and tender lesions were reported as other important medical events. Additional information has been requested.
Unknowingly given undiluted dose to pt.  Vial was open and ready to use on correct tray under right chart. Later on I found out vial was not diluted yet.   Mom notified of event.
This medically confirmed report (initial receipt 25-Nov-2014) concerns a 14 year old male patient. On the 07-Nov-2014, the patient received the influenza virus vaccine (manufacturer and batch number not reported) and the GARDASIL (batch number not reported) on the same day. On the 13-Nov-2014, the patient had a stroke. Outcome was not reported.
At one month exam had a mobile 1.25 cm soft tissue swelling at one and two months. Well child check, parents stated it was there shortly after receiving shot but there is no mention at 1 wk well child exam. Area was never erythematous or tender to touch. At two months xray confirm soft tissue swelling with no bony involvement or mass. On 8/21/18 discussed with physician who feels this is a sterile abscess, likely secondary reaction to aluminum hydroxide contained in vaccine with body reaction treating it as a foreign body. It is still present and similar in size at three months of age. Recommendation at this time is not to drain and to follow clinically. Pediatrician will recommend follow up with another Dr. for further vaccine recommendations. Currently infant is deficient on vaccines because we cannot use left thigh.
pt given APAP prior to vax; had fever 102.2, next day very febrile & required APAP q 4hr (99.6-102), irritable-needing to be held cont that day;
Hives all over body after 1st rabies vaccine on 8/18/21.  Received second dose of rabies on 8/21/21  Hives began two days after initial dose and less than 24 hrs after 2nd dose.  Treated with Benadryl and Xyzal
After the vaccine I started hearing a buzzing/ringing in my ears and I've never had this issues before
48 YO F complaining of Nausea. EMS Evaluation, 4-lead, 12-lead, BP, BS. Diagnostics reveal hypotension 90/64. EMS recommend transport. Pt agrees to transport. Pt care transferred @1448. Final BP 84/57. EMS suggest likely dehydration.
With lots of adverse reactions; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (With lots of adverse reactions) 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.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, 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 experienced VACCINATION COMPLICATION (With lots of adverse reactions). At the time of the report, VACCINATION COMPLICATION (With lots of adverse reactions) outcome was unknown.            No concomitant medications were provided. No treatment medications were reported.   This case was linked to MOD-2021-344276 (Patient Link).
About four weeks ago I started to notice that my temperature is rising a degree or two. My doctor has me checking it every day around 5 PM. In the early evening, I feel like I don't have any energy at all. I did get a flu shot a month after receiving my dose.
Approximately 3-4 hours after receiving FLUZONE, the patient reported to E.R. with complaints of chest pain and difficulty breathing. Patient was successfully treated with an extended steroid therapy course and BENADRYL.
Two days after the vaccine, I had the common symptoms of a heart attack for several days. I went to Urgent Care on 05-18-2021, and they told me to go to the ER. I went to the ER, and they admitted me to the hospital in the cardiology department of Medical Center. Then I was there until the next day. The hospital ran numerous tests, including several blood panels, several EKG's, a CT Scan, and a nuclear stress test. I will have many big hospital bills from this.
Elevated resting heart rate for 2-3 days after both shots one and two; tachycardia when exercising following shot 2. Recently had a cardiology workup prior to the vaccine and all was normal. Had the second shot on Feb 26 and had elevated resting heart rate for 2-3 days. On days 5 and 6, tried to exercise and had heart rate spikes in the 170s. Felt very tired and short of breath. Went to urgent care for EKG, which was normal. Rested for a few days. Day 10, tried to exercise, again had heart rate spikes ? 168, 172, 183.
Developed fevers, malaise and headache within 24 of administration of Menactra.  Now feeling somewhat better 4 days after administration.  Previously received a dose of Menomume in 2002, without side effects.  Patient works in a clinical microbiology laboratory and handles cultures of Neisseria meningitidis.
pt recv vax 31OCT96 & had sore arm same day;next day had fever to 102, chills, cough, aching all over;called on Monday 4NOV96 to report;advised to call own MD;
Generalized Vaccinia (<50 pustule like lesions) over trunk and extremities. 12/18/06 pustular lesions resolved. Returned to work no restriction.
Hives over entire body; prednisone 40mg + benedryl 25mg, allegra 180mg; hives subsided within a couple hours however still experiencing migraines vertigo and acid reflux 4 days post reaction and 6 days post vaccine administration.
pt brought to ED via EMS with c/o increasing dyspnea and non-productive cough for several days; placed on NRB; positive for COVID; treated with Decadron, antibiotics; O2 demands increased over hospital stay eventually requiring 40L High Flow and NRB mask; respiratory failure progressed and he eventually passed away in the hospital.
Chills/fever,  mild headache, fatigue. Vaccine was given on a Friday afternoon, symptoms presented around 2200-2300 that night and were at their peak all day Saturday. By Sunday all symptoms were still present but the fever had mostly resolved. Some fatigue persisted the rest of the week (Monday through Friday).   The following week after receiving the vaccine I experienced fever (up to 104F taken in clinic) fatigue, lack of appetite, abdominal discomfort. I was diagnosed with diverticulitis in the ER so the fever was attributed to that. Just wanted to note that I have had flare ups over the past few years but was never febrile. Also of note is that I had been taking INH and Rifampin which may have caused and/or contributed to some of the adverse effects.
This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in 5th November 2020).   On an unknown date, the patient received the 2nd dose of Shingrix (injection). On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter consented to follow up.
Patient had swelling around injection site that persisted for 5 days. Erythematous 1.5" diameter and further swelling to the elbow (about 6" in diameter). Gave patient BENADRYL 50mg at day 3 and was okay.
Indurated wheal - 3 cm diameter around injection site and surrounding pale, pink swelling approximately 10 cm diameter.