chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Administered more than 12 hours post the initial vial puncture; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered more than 12 hours post the initial vial puncture) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered more than 12 hours post the initial vial puncture) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered more than 12 hours post the initial vial puncture) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Administered more than 12 hours post the initial vial puncture).    No concomitant medications were reported.  It was reported that a dose was administered form a vial that had been previously punctured. The HCP was not sure when the initial puncture time or date was and was concerned that it may had been administered  more than 12 hours post the initial vial puncture.  No treatment medications were reported.
On Saturday, I started itching in the inside of my lower arm between my wrist and elbows (both -  mainly my right arm but left arm was itchy too). I had splotches like a rash and light red bumps. My arms puffed up a little (both). It looked like corduroy fabric -  red like line indentations. I started using aloe vera. That helped a little bit. I had some Cephafil cream (OTC). I thought I had a reaction to something in the soil from yardwork I was doing. I had redness and a rash in my knuckles - between palm in my hand and my knuckle of where it bends - they were red; rough and raw. There was a little rash on the tops of my hands. I went to the doctor on the 12th and he prescribed. I used it for four days: Trimethadione cream with an acetate name on the end of it. My right arm did have a little swelling around the elbow joint.
Patient was given Moderna vaccine at another clinic at age 15. With Medical Director's approval, she came to Public Health to receive 2nd Moderna vaccine. Parental consent received prior to vaccine administration.  Patient observed for 15 minutes in clinic and had no adverse reactions.
This spontaneous report as received from a physician via a company representative refers to a 7 month old female patient. There was no pertinent medical history and concomitant therapy reported. On 08-AUG-2014 the patient was vaccinated with the first dose of ROTATEQ (oral, dose, frequency and lot # not reported). On 08-JUL-2014 the patient was vaccinated with the second dose of ROTATEQ (lot # J010985, expiration date 24-APR-2015, oral, dose and frequency not reported). On 08-AUG-2014 the patient was vaccinated with the third dose of ROTATEQ (lot # J015690, expiration date 14-OCT-2015, oral, dose and frequency not reported). The physician reported that on 23-SEP-2014 the patient had an adverse effect after receiving the third dose of ROTATEQ, it was reported that the adverse event was intussusception. The patient was taken to the emergency room (ER) but was not admitted (also reported as the adverse event (AE) occurred after the third dose). The patient was given unspecified treatment for the adverse event. The outcome of the event was reported as recovered (in an approximately September 2014). The relatedness between the event and ROTATEQ was not reported. Additional information has been requested.
Client reports pain, oozing, itching, painful blisters going across her back with some going down her spine.
Your Covid vaccine doesn't work I've had Covid twice since getting it both doses I've gotten and still got it; Your Covid vaccine doesn't work I've had Covid twice since getting it both doses I've gotten and still got it; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "not recovered" and all described as "Your Covid vaccine doesn't work I've had Covid twice since getting it both doses I've gotten and still got it". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: I've had Covid twice since getting it both doses.  Clinical information: Patient reported that your Covid vaccine doesn't work I've had Covid twice since getting it both doses I've gotten and still got it Your Covid vaccine doesn't work I've had Covid twice since getting it both doses I've gotten and still got it.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Death occurred; I performed an autopsy (I'm a Medical Examiner/forensic pathologist) and ultimately certified the death as follows:  Cause of death: Congestive Heart Failure due to Atherosclerotic and Hypertensive Cardiovascular Disease. Other significant conditions: Class 1 Obesity. Manner of death: Natural.  There is NO evidence to indicate that the vaccination is related to her death.
About one week after first dose I started exp heart palpitations.When I exercise it became worse I went to ER at the Hospital. My symptoms has got worse since Dose 2. I got a job at the Farmers Market due to my heart palpitations couldn't perform the job duties of lifting and stocking.  On September 3,2021 went back to the ER at a different Hospital I was informed to see a cardiologist and was told I could have a underlying thyroid condition. I have seen a cardiologist was had tests sent with  a holter monitor.I have seen my PCP about the thyroid issues to see if related to heart palpitations due to my thyroid hormones are low. My PCP has referred to the Endocrinologist.
Hematoma was noted immediately after giving vaccination. Patient was advised to use ice packs or OTC pain relievers if necessary. After 15 minutes of post-vaccination monitoring, patient reported feeling burning sensation up and down the arm and side of neck. Aside from the vaccination site no redness, swelling, or hives were visible. Patient stated no trouble breathing or lightheadedness and was told to monitor for another 15 minutes. After the 15 minutes had passed, patient reported sensation was slowly dissipating but still noticeable.  Patient was advised to continue monitoring at home for the next 24 hours and to seek medical attention if symptom worsens or new unusual symptoms develop.
Soft stools, loss of appetite and runny nose for 3 days. Also, tinnitus (bilateral) starting about 1 hour after dose and lasting several hours.
Received MENVEO on 5/22/18 in (R) arm. Tuesday night-achy, 2 out of 10. Achiness down arm. Very itchy. 5/23/18-evening shower noticed red rash, swelling.
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 POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Mar-2021 at 3:40 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 20-Mar-2021, 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, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (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.   No concomitant medication were provided.  Age of patient was reported as 22.05 for dose administered on 20-Mar-2021.   On 20-Mar-2021, the vaccine with batch number 031A21A was moved to fridge on 09-Mar-2021, 19 vials were moved to the clinic on 20-Mar-2021 at 09:00 AM to 10:00 AM, vials underwent temperature excursion with temperature of 34 to 37 degrees Fahrenheit. The condition of vaccine prior to vaccination was not frozen. The vaccine beyond use date was reported as 08-Apr-2021..  It was reported that, the storage condition at the time of the excursion was cooler storage during high-pace COVID-19 vaccination clinic. 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 traceable temperature monitor at every hour.  It was reported that, the patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021. The health care professional explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 hour and a half approximately, when the temperature data logger No treatment medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).
acute appendicitis; abdominal pain; profuse vomiting; This is a spontaneous report from a contactable nurse (mother). A 28-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscularly, on 22Mar2021 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. Medical history included mild reactive airway, seasonal allergies, and mild eczema. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications, taken within two weeks of vaccination, included unspecified birth control pills. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscularly, for COVID-19 immunisation and experienced no problems. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced acute appendicitis, abdominal pain, and profuse vomiting on 24Mar2021. The events caused hospitalization from 24Mar2021 to an unspecified date. The clinical course was reported as follows: In the early morning hours of 24Mar2021, the patient developed severe abdominal pain and profuse vomiting, and went to the emergency room (ER). A computerised tomogram (CT) scan revealed acute appendicitis on 24Mar2021, and she had an appendectomy the same day. At the time of reporting, the patient was currently in the hospital but was reported to may be discharged home later that day (24Mar2021). The patient underwent lab tests and procedures which included COVID-19 test: unknown results on 24Mar2021. Therapeutic measures were taken as a result of all of the events as aforementioned. The clinical outcome of acute appendicitis, abdominal pain, and profuse vomiting was not recovered.  The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on the information currently available, the events acute appendicitis abdominal pain, and profuse vomiting most likely represent intercurrent medical conditions and are unrelated to Bnt162b2 vaccine. Case will be re-assessed upon the additional information provided. 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.
Headache, Myalgia, UrticariaPruritus, chills, arm soreness Narrative:  Headaches, myalgia, chills, sore arm; resolved.
Patient presented with a raised red mark around the injection site that she claims began a few hours after immunization. Patient states that it began small and slowly grew in size. She also presented with another, similar mark on her left forearm that she states began a few days ago.
Hives. I woke up the morning after receiving the Moderna booster dose with hives on my left deltoid which is where I got the shot. Since then, I have been suffering with hives everyday and now have to take cetirizine 40 mg/d to control them. I hope this doesn't go on much longer. I am eligible to get a 2nd booster dose and will do so next week, but I will choose the Pfizer vaccine since my initial 3 vaccines were Moderna. What is worse, chronic daily hives or Covid-19 infection? Probably Covid, but hives are definitely a form of torture!
2.5 inch welt or hive at injection site; 2.5 inch welt or hive at injection site; a orange sized swelling in armpit of left arm,; muscle fatigue; pain across pectoral muscles; Itchy red skin up and down left arm and neck.; Itchy red skin up and down left arm and neck.; Nausea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Sep2022 as dose 3 (booster), single (Lot number: FF2593), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "allergies" (unspecified if ongoing); "Known allergies: Pomegranate" (unspecified if ongoing); "Known allergies: red 40" (unspecified if ongoing). Concomitant medication(s) included: FLU VACCINE VII taken for immunisation, on 01Sep2022 as dose number unknown, single. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for Covid-19 Immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for Covid-19 Immunization. The following information was reported: VACCINATION SITE PAIN (non-serious), VACCINATION SITE URTICARIA (non-serious), outcome "recovering" and all described as "2.5 inch welt or hive at injection site"; SWELLING (non-serious), outcome "recovering", described as "a orange sized swelling in armpit of left arm,"; MUSCLE FATIGUE (non-serious), outcome "recovering"; MYALGIA (non-serious), outcome "recovering", described as "pain across pectoral muscles"; PRURITUS (non-serious), ERYTHEMA (non-serious), outcome "recovering" and all described as "Itchy red skin up and down left arm and neck."; NAUSEA (non-serious), outcome "recovering". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of vaccination site pain, vaccination site urticaria, swelling, muscle fatigue, myalgia, pruritus, erythema, nausea.  Additional information: The other vaccine within 4 weeks included Flulaval Quadrivalent. There was no covid prior vaccination and not tested post vaccination. It was reported that the patient experienced 2.5 inch welt or hive at injection site, a orange sized swelling in armpit of left arm, muscle fatigue and pain across pectoral muscles. Itchy red skin up and down left arm and neck Nausea.
Fever- chills- headache. Severe pain in right arm/injection site Pain on right side of body
Increasingly short of breath, lethargic. O2 sat dropped to 75%. Placed on 10 liter oxygen. BP 150/70 (pulse 74). BP 126/97. BS 292. Sent to the ED.
A little tenderness around injection site; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 81 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 22Feb2021 (Lot number: EN6200) at the age of 81 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Arthritis" (unspecified if ongoing), notes: he had the mild arthritis for years. The patient's concomitant medications were not reported.  The following information was reported: VACCINATION SITE PAIN (non-serious) with onset Feb2021, outcome "recovered" (2021), described as "A little tenderness around injection site". Therapeutic measures were taken as a result of vaccination site pain.  No follow-up attempts are possible. No further information is expected.
severe dizziness and palpitations with any change in posture- Postural Orthostatic Tachycardia Syndrome. was severe for 4 weeks but is still intermittently present 6 weeks later. I had to move a recliner to my clinic office to be able to get through my work day. could not stand for more than 5minutes without feeling that I would fall down.  nausea x 2 weeks severe fatigue limiting activity x 4 weeks chest pain x 4 weeks (intermittent associated with tachycadia, no association with activity or food, pleuritic in nature, lasted 5-30 minutes at a time, no chest pressure, no sweating with it)  I am better but not fully recovered.
NUMBNESS IN LEG; PAIN IN HIS RIGHT LEG BELOW THE CALF AND PAIN MOVE UP AND INCREASING IN SEVERITY; BODY PAIN; DIZZINESS WHEN HE STOOD UP; CHILLS; FEVER; This spontaneous report received from a patient concerned a 45 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A expiry: UNKNOWN) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-APR-2021 02:00, the subject experienced chills. On 11-APR-2021 02:00, the subject experienced fever. On 11-APR-2021 06:00, Laboratory data included: Body temperature (NR: not provided) 100.7 (unit not reported). On 12-APR-2021 06:00, the subject experienced body pain. On 12-APR-2021 06:00, the subject experienced dizziness when he stood up. On 13-APR-2021, the subject experienced numbness in leg. On 13-APR-2021, the subject experienced pain in his right leg below the calf and pain move up and increasing in severity. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain in his right leg below the calf and pain move up and increasing in severity, and numbness in leg, and the outcome of fever, chills, body pain and dizziness when he stood up was not reported. This report was non-serious.
Muscles hurt and was weak; Muscles hurt and was weak; got excited; tongue became swollen; fell down; felt so weak that he could not lift himself to get up; This is a spontaneous report from a contactable consumer or other non-hcp (Patient).  A 78-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Batch/Lot Number: Unknown, Expiration date: Unknown) via an unspecified route of administration on 25Jan2021 as a single dose for COVID-19 immunization. Medical history included COVID-19 from Jul2020 to an unknown date; he also mentioned that he had COVID-19 back in July but has already recovered. The patient's concomitant medications were not reported. On an unspecified date in Jan 2021, the following day, he woke up and his tongue was swollen. He got excited and called doctor and he went in. He went to get dressed and as he went in, he fell down. Then he is trying to get up and cannot get up. He layed there for 1/2 hour. He could not get up. He was trying and trying. His wife had to call neighbors to help him get up. He did not want to go to the hospital and wait for 2-3 hours. He took some Benadryl and a couple of Aspirin and fell asleep. The following day when he woke up, his mouth was not swollen and he was able to get up and around. His muscles hurt and he felt like a weakling. The clinical outcome of tongue became swollen, fell down, felt so weak that he could not lift himself to get up was resolved and the outcome of other events was unknown.  He is scheduled to get second dose on 24Feb2021. He would like to know if he should get it or not. He was an EMT in Fire Department before he retired. That day when it happened, he really felt old. No further details provided. The seriousness of the events was reported as non-serious.   Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
This spontaneous report was received from a nurse referring to a 7 years old female patient. The patient's medical history and concurrent conditions were not reported. On an unknown date (reported as "at age 1 year"), the patient was vaccinated with her first dose of VARIVAX, and subsequently, on an unknown date (reported as "at age 5 years"), she was vaccinated with her second dose of VARIVAX, (route of administration, lot # and expiration date were unknown). Concomitant medications were not reported. On an unknown date (reported as "at 7 years old"), the patient developed a case of shingles. At the time of reporting, the patient had recovered from the Herpes zoster. The causality assessment between the Herpes zoster and VARIVAX was not provided. Additional information is not expected, no permission for further contact was provided.
Patient's arm was sore about 1 hour after injection. Within 24 hours, she had a red oval swollen area from the shoulder to the elbows. Lasted about 1 week then was gone.
This is a spontaneous report from a non-contactable consumer. A patient of unspecified age, ethnicity and gender received PREVNAR 13 l(ot number unknown), via an unspecified route of administration on an unspecified date as single dose for immunization.  The patient's medical history included patient had no spleen.  The patient's concomitant medications were not reported.  The patient experienced sick and mucus on an unspecified date. The event was described by patient has been sick ever since and  noted up with mucus after vaccination. The outcome of sick and mucus was unknown. No follow-up attempts are possible. No further information is expected.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. Medical history and drug reactions or allergies were not specified. On an unknown date, unspecified number of patients were administered doses of PROQUAD (Merck) injection (dose, route and lot number were not reported) that were improperly stored. Concomitant medications were not specified. No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Woke up middle of night about 12hr after getting vaccine with stiff painful neck. Stiffness diminished after 3 days ibuprofen OTC. At first did not relate it to vaccine but then she heard of someone else who experienced same thing so she decided to report it now. Is not currently having any problems.