chrisvoncsefalvay/vaers-outcomes huggingface dataset:
inadvertently was given a dose of the Pfizer Covid 19 vaccine yesterday that was not diluted; inadvertently was given a dose of the Pfizer Covid 19 vaccine yesterday that was not diluted; usually does not take naps or sleep a lot because he does not product melatonin/ has been asleep for 3 hours; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the parent.  A 5-year-old patient received BNT162b2 (BNT162B2), on 04Aug2022 as dose 2, single (Batch/Lot number: unknown) at the age of 5 years for covid-19 immunisation. The patient's relevant medical history included: "hemophilia" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: PRODUCT PREPARATION ERROR (non-serious), OVERDOSE (non-serious) all with onset 04Aug2022, outcome "unknown" and all described as "inadvertently was given a dose of the Pfizer Covid 19 vaccine yesterday that was not diluted"; SOMNOLENCE (non-serious) with onset Aug2022, outcome "unknown", described as "usually does not take naps or sleep a lot because he does not product melatonin/ has been asleep for 3 hours".  Additional Information: The reporter is the mother of a 5 year old male who inadvertently was given a dose of the Pfizer COVID-19 vaccine yesterday that was not diluted. She would like to know what they should do. She relayed that he usually does not take naps or sleep a lot because he does not product melatonin. He has been asleep for 3 hours. He also has hemophilia. The reporter said that her five year old daughter (further clarification unknown, if the reporter is reporting for daughter or the son) received her second dose of the vaccine yesterday and she was telling that the nurse administered the vaccine and they didn't dilute it and the caller does not know the color of the cap, the Pfizer COVID-19 Vaccine. Reporter just wanted to know what to do for her son (Further not clarified appropriately, if reporter is reporting for the son or the daughter) that was administered the vaccine incorrectly.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 05-MAY-2016, the patient was vaccinated with an improperly stored dose M-M-R II injection, 0.5 ml lot # L026553, expiration date 16-JUL-2017 (route and site of administration were not reported). According to the reporter, the vaccine was stored at a temperature of 11.1 degrees Celsius for 1 hour and 36 minutes and also at a temperature of -12.3 degrees Celsius for 1 hour and 33 minutes (excursion dates were not reported). Digital data logger was involved. No adverse symptoms. This is one of several reports received from the same reporter. Additional information has been requested.
Received a Meningococcal B and Meningococcal ACWY vaccines. Complained of extreme fatigue, arm soreness, and ringing in ears for approximately 36 hours.
Moderna COVID-19 Vaccine EUA  dizziness room spinning had trouble standing, light headed, vomiting drinking water made it worse for a short time, shakiness, head ache the lights in the er room made this worse.
Felt sick; Felt like her uterus and other internal organs on were on fire; Had body aches; Fever; This spontaneous case was reported by an other health care professional and describes the occurrence of ILLNESS (Felt sick), BURNING SENSATION (Felt like her uterus and other internal organs on were on fire), PAIN (Had body aches) and PYREXIA (Fever) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced ILLNESS (Felt sick), BURNING SENSATION (Felt like her uterus and other internal organs on were on fire), PAIN (Had body aches) and PYREXIA (Fever). In 2021, ILLNESS (Felt sick), BURNING SENSATION (Felt like her uterus and other internal organs on were on fire), PAIN (Had body aches) and PYREXIA (Fever) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient was in contact with ophthalmologists.  The patient took no concomitant medications and no medications to alleviate the symptoms.   This case was linked to MOD-2021-417751, MOD-2021-417772 (Patient Link).
pt admitted to hospital with c/o cough, SOB, myalgias, dyspnea on exertion x 3 days; O2 sats 54% on RA; O2 supplementation with Vapotherm and additional NRB; found to be positive for COVID; given remdesivir and on steroids; ICU; hosp course complicated by E Coli bacteremia, received ABX; rapid response for hypoxia called due to acute sub-massive PE; TPA and Lovenox; intubated; eventually pt was able to be extubated and placed on NRB; pt refused to be intubated again even though O2 sats weren't good; transitioned to comfort care and passed away in the hosp
PT DAUGHTER REPORTED SWELLING AND HOT AT THE SITE OF INJECTION  AND SOME SWELLING AND HOTTNESS THAT  WENT DOWN THE ARM TO ELBOW- A LITTLE  ITCHING AT THE SITE --  REACTION WAS REPORTED THE DAY AFTER IMMUNIZATION --TOLD PT TO    ICE ARM AND TAKE IBUPROFEN   AND MAYBE A BENADRYL IF ITCHING GOT WORSE--  IF SWELLING  GOT WORSE OR IF BREATHING PROBLEMS --GET TO ER AND HAVE DR. CHECK HER OUT
during refill, process patient reported a decrease in efficacy of stelara after having covid vaccine. he  reports stelara was working very well prior to vaccine.  after vaccine, patient experienced a severe flare. md is aware and increased dosing frequency of stelara. no other info provided. solicited report.
Circular-ish red rash, warm to touch. Lasted two days. Day one was itchy, day 2 became the rash and warm to touch
Pt recv vax on 8/25/98; on same day pt exp body itching x3 day; red, sore, swollen Rt arm x6 day;headache x 1wk; tight chest x 3dy; cough as of 9/3/98;tx=Benadryl,Tylenol,Oxymetazalin,Atarax. 9/7/98 pt imp.
My glucose spiked in the middle of the night to over 200, a mild sinus infection, my liver seemed to swell very large and then shut down somewhat as evidence by blonde feces and undigested food. out of breath a lot,  a very weak and exhausted spine, fatigue in general, and extreme thirst, and headache.  These symptoms were not as prominent the first week of the shot, but the following two weeks they were and even now there still some glucose and liver issues that may be the cause of being out of breath.
11:30 am patient c/o lightheadedness in observation area, RN transferred to EMS room for observation. FNP ordered benadryl 50mg by mouth now given to patient with H2O. Patient allowed to rest in EMS room. Denies chest pain, shortness of breath at this time, was discharged in stable condition with spouse @ 12:25pm BP: 148/99
Peripheral Edema (calves, ankles, and upper feet) within 24 hours after injection. Persistent but declining over the course of three weeks, until the 2nd dose. A repeat of the above occurred within 24 hours of the 2nd dose, same results.
12MAY94 pt recvd vax & 13MAY93 localized react of erythema, itching, swelling approx 40 mins;
Shooting pain doesn't seem to get better, started from arm, wrist, hand, back and now radiated to left leg.
loss stool; tired; not much energy; injection site was a little more sore; redness; injection site got full blow; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (loss stool), FATIGUE (tired), ASTHENIA (not much energy), VACCINATION SITE PAIN (injection site was a little more sore) and ERYTHEMA (redness) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (loss stool), FATIGUE (tired), ASTHENIA (not much energy), VACCINATION SITE PAIN (injection site was a little more sore), ERYTHEMA (redness) and VACCINATION SITE SWELLING (injection site got full blow). At the time of the report, DIARRHOEA (loss stool), FATIGUE (tired), ASTHENIA (not much energy), VACCINATION SITE PAIN (injection site was a little more sore), ERYTHEMA (redness) and VACCINATION SITE SWELLING (injection site got full blow) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Patient passed out in front of the pharmacy counter and fell down. Patient quickly gained consciousness (the moment pharmacist reached patient's side which was within less than 10 seconds). Patient opened their eyes and answered questions with no difficulties in loss of whereabouts. Patient was offered water and drank water after being seated up right after a minute of laying on the ground. After drinking water, patient requested to move (with assistance) to the nearby chair where she waited for a few minutes before the emergency services arrived.
High fever (102) throughout the first night. Took one tylenol Lower fever throughout the day.  High fever again the second night (102) took one Ibuprofen Flu-like Body aches throughout 36 hours
Pt called back to mobile clinic to report she had a swelling tongue and side of her face, 2 hours after injection. The staff she spoke to referred her to the nearest ER which was Medical Center.  I called to check on her and she stated they had admitted her to their hospital for testing and she would call me when she had a clear idea of what was wrong. She also reported facial paralysis and neck and shoulder paralysis as well as a "knot that came up in a matter of seconds, the size of a golfball in her neck".   She called back today 10/7/2021 to tell me she was discharged from hospital and was told she had suffered "a blood clot on the brain stem". She said she is better now. Not d/c home on any anticoagulants or new meds. Was told not to take another Covid vaccine.
No adverse effects have been noted to date. According to CDC recommendations listed here: on website, the patient returned to the clinic and was given a repeat dose by IM route the same day.
Moderna COVID-19 Vaccine EUA.  Received 2nd dose 03/27.  March 30 noticed area about 2 inches below injection site that was red, hard and hot, slightly painful.  The area was about 3 fingers in size.  The symptom lasted about 2 days.  No treatment was necessary.
pt recv vax 15NOV96 & pt devel high fever 104 & broke out into a rash on 24NOV96;
Positive COVID-19 test; Positive COVID-19 test; This is a spontaneous report received from a contactable physician.  A patient of unknown age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA, Solution for injection, Lot Number: Unknown) via an unspecified route of administration on an unknown date at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient had COVID and a positive test recovered. Patient received Pfizer vaccine, first dose. Reporter enquired about the need of a second dose. Outcome of the events was recovered.  Information on lot/batch number has been requested.; Sender's Comments: The information currently provided is too limited to make a meaningful medical assessment. There was no vaccination timeline given relative to occurrence of event. Based solely on temporal relation, a causal relation between 'drug ineffective', 'Covid-19' and BNT162B2 vaccine cannot be totally excluded. This case will be re-assessed if relevant information is received.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Back spasms, stomach cramps, diarrhea, coughing, swelling of airway, shortness of breath - started at 9:30 pm - 7 hours after vaccination. Treatment - BENADRYL, steroid injection, Albuterol, Prednisone.
First grand mal seizure; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 19 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date Jan2021 (Batch/Lot number: unknown) at the age of 19 years as dose 2, single for covid-19 immunisation at a pharmacy or drug store. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1), administration date: Nov2020, when the patient was 19 years old, for Covid-19 Immunization. Clinical Course: The patient had her first grand mal seizure almost 3 weeks after her 2nd COVID-19 vaccine dose.  Her seizures began in early Feb2021. She has had several more since and the cause was unknown. The following information was reported: GENERALISED TONIC-CLONIC SEIZURE (hospitalization, medically significant) with onset Feb2021, outcome "not recovered", described as "First grand mal seizure". The patient was hospitalized for generalised tonic-clonic seizure (hospitalization duration: 3 day(s)). The event "first grand mal seizure" was evaluated at the physician office visit and emergency room visit. Therapeutic measures were taken as a result of generalised tonic-clonic seizure included unspecified seizure medication and monitoring.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Felt weird feeling on left side of face/body (Received shot in left shoulder).  The only way I could describe it was that the face symptoms almost felt like a very minor sensation of novacane (like during/after a detal procedure).  But not the numbness when that fully sets in, the early onset feeling before numbess.  I didn't feel numb.  My left eye also felt a little dry (possibly).  My left leg felt a little bit of this weird sensation too.  I actually looked in the mirror to see if the left side of my face looked any different (it didnt).  My left ear also got warm/pink.  My ears getting warm/pink is a typical sign of a cold (for me).  These symptoms lasted at least until Monday 10/13/14 -dissipating a little each subsequent day.  So, approx. 4 days.  I received no treatment for these side effects except maybe over the counter ibuprofen. I hope this helps.  It was the first time I have received a flu shot.
Redness and swelling at the injection site and hot to touch. This resolved after 2-3 days, but mother took a long time to get back to us after multiple attempts.
This case was reported by a consumer via call center representative and described the occurrence of fever in a 2-month-old male patient who received KINRIX. On 25th July 2016, the patient received KINRIX. In July 2016, less than a week after receiving KINRIX, the patient experienced fever. On 25th July 2016, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the fever and inappropriate age at vaccine administration were unknown. It was unknown if the reporter considered the fever to be related to KINRIX. Additional details were provided as follows: The reporter stated that the 9 weeks old patient was administered with KINRIX and experienced fever, which also led to an inappropriate age at vaccine administration.
patients were inadvertently administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a 33-year-old female patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On 11-OCT-2023, the patient received Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced incorrect storage of drug (Verbatim: patients were inadvertently administered). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK Receipt Date: 31-OCT-2023 The pharmacy operations manager called to report three patients were inadvertently administered Boostrix that was exposed to 70 Fahrenheit for up to 32 days.  Manager mentioned the Boostrix was left in the stock room and three patients received it during that time. The HCP unable to provide vaccine details of lot and expiration. The patient received temperature excursed product, which led incorrect storage of drug. The reporter did not consent to follow-up from safety. The case is linked with case US2023151105 and US2023151106, reported by the same reporter, for different patients.; Sender's Comments:  US-GSK-US2023151106:same reporter US-GSK-US2023151105:Same reporter
Whole body ache (ongoing) Extreme headache (ongoing) Chills (intermittent) Tingling in extremities (intermittent) Confusion (intermittent) Fatigue (ongoing)
Medical assistant calling to report a temperature excursion that occurred 8/14/2020 which involved the following products: GARDASIL9, PEDVAXHIB, RECOMBIVAX, ROTATEQ. Per caller, "it would be possible that at least 100 patients have received vaccines; This spontaneous report was received from a medical assistant, concerning a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies or concomitant medications were not reported.  On 19-AUG-2020, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 0.5 ml orally as prophylaxis (lot # 1660974 with expiration date 20-APR-2021) (strength and frequency were not reported).  The improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) experienced a temperature excursion of 35.4 Fahrenheit degrees (°F) for the time frame of 20 minutes without previous temperature excursions. It was confirmed that a digital data logger was involved.  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2009USA006106:
PATIENT REPORTS NUMBNESS DOWN HER RIGHT ARM AND TINGLING IN HER RIGHT HAND AND FINGERS. SHE ALSO REPORTS PAIN IN HER RIGHT FOREARM AND SHOULDER.
whole deltoid muscle that was injected and is bright red/ underarm is also bright red; her arm started to hurt again/underarm red and sore; very sore; joints were painful/ joints were really sore; muscles and joints were really sore/ whole body ached; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (her arm started to hurt again/underarm red and sore), VACCINATION SITE PAIN (very sore), ARTHRALGIA (joints were painful/ joints were really sore), VACCINATION SITE ERYTHEMA (whole deltoid muscle that was injected and is bright red/ underarm is also bright red) and MYALGIA (muscles and joints were really sore/ whole body ached) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced VACCINATION SITE PAIN (very sore). In February 2021, the patient experienced ARTHRALGIA (joints were painful/ joints were really sore) and MYALGIA (muscles and joints were really sore/ whole body ached). On 17-Feb-2021, the patient experienced PAIN IN EXTREMITY (her arm started to hurt again/underarm red and sore). On 18-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (whole deltoid muscle that was injected and is bright red/ underarm is also bright red). At the time of the report, PAIN IN EXTREMITY (her arm started to hurt again/underarm red and sore) and VACCINATION SITE ERYTHEMA (whole deltoid muscle that was injected and is bright red/ underarm is also bright red) outcome was unknown, VACCINATION SITE PAIN (very sore) had resolved and ARTHRALGIA (joints were painful/ joints were really sore) and MYALGIA (muscles and joints were really sore/ whole body ached) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  On 18-FEB-2021, patient's underarm became bright red and very sore. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2021: Additional information received reporter contact details updated.
Felt like cold symptoms to start, achy and stopped up. Within 10 hours I had a 103-degree fever with TYLENOL. Went to urgent care to test. Doctor tested for COVID-19 with a PCR test, positive. Doctor prescribed amoxicillin, and monoclonal antibodies. Fever went down within 2 days but was still over 100. I was very sick for about 10 days, using a portable oxygen concentrator to keep O2 Sats up. The final 4 days symptoms gradually improved to basically non-existence. At about 21 days, sever bronchitis developed. Took a round of anti-inflammatory and antibiotics. Then the bronchitis returned for a second round of antibiotics. Then in October, there was an SVT event that did not result in hospitalization. By November all pulmonary functions returned to baseline. Also developed diarrhea that lasted into January. Exocrine Pancreatic Insufficiency and a yeast infection in the colon. Symptoms started with stomach problems exactly 90 days after the positive COVID-19 test.
I feel that I am having an adverse reaction to the Anthrax shot I received on Sunday (8Feb09).  I have been experiencing itching from the spot where the needle broke skin radiating outward in all directions to a distance of approximately 1.5 inches from the point of entry.  There's also some mild pinkness associated in that area as well.  Pretty much all of my Anthrax shots have created this reaction.  The difference this time is that I have been experiencing extreme muscle soreness from the point of entry radiating up across the top of my shoulder, through the deltoid area ending at the base of my skull.  It feels as though I have pulled a muscle and now cannot turn my head.  The pain is less today (10 Feb 09), so far then it was yesterday (9 Feb 09) but I thought that it'd be a good idea to let someone know about this reaction.
Rapid heartbeat, heart palpitations, elevated blood pressure. Had EKG, placed on metoprolol 50 mg. No prior adverse reactions to flu shots. Moth had similar reaction in Sept. 2010 to vaccine.
POTS like symptoms, undergoing testing for possible diagnosis of MCAS,   Heavy menstrual pain and bleeding, intensive hives and skin rashes, tachycardia, fatigue, feeling faint, migraines, light and sound sensitivity, and joint and leg pains
the patient did not receive his second dose of GARDASIL 9 on an unspecified date in April 2020; This spontaneous report was received from a pharmacist referring to a 31 years old male patient. The patient's concomitant medications, pertinent medical history and drug reactions/allergies were not reported.  On an unspecified date in February 2020, the patient was vaccinated with the first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (strength, dose, frequency, route, lot # and expiration date were unknown) for prophylaxis. He did not receive his second dose of GARDASIL 9 on an unspecified date in April 2020 (inappropriate schedule of product administration).