chrisvoncsefalvay/vaers-outcomes huggingface dataset:
having reactions to the vaccine; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of VACCINATION COMPLICATION (having reactions to the vaccine) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 15-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 VACCINATION COMPLICATION (having reactions to the vaccine). At the time of the report, VACCINATION COMPLICATION (having reactions to the vaccine) outcome was unknown. Not Provided      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 concomitant medications were provided. No treatment information provided.
Vial was first punctured on 10Jun2022 at 1:05 PM and stored post puncture in a container to protect from the light and kept in the fridge and administered on 13Jun2022.; doses were administered past the 12 hour post puncture period; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses were administered past the 12 hour post puncture period) and PRODUCT STORAGE ERROR (Vial was first punctured on 10Jun2022 at 1:05 PM and stored post puncture in a container to protect from the light and kept in the fridge and administered on 13Jun2022.) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jun-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jun-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses were administered past the 12 hour post puncture period). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was first punctured on 10Jun2022 at 1:05 PM and stored post puncture in a container to protect from the light and kept in the fridge and administered on 13Jun2022.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (doses were administered past the 12 hour post puncture period) and PRODUCT STORAGE ERROR (Vial was first punctured on 10Jun2022 at 1:05 PM and stored post puncture in a container to protect from the light and kept in the fridge and administered on 13Jun2022.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  On 13-Jun-2022, the patient received booster dose (batch no. 058A22-2A) of Moderna COVID-19 Vaccine.  Vial was initially stored in the refrigerator on 09-Jun-2022 and was first punctured on 10-Jun-2022 at 1:05 PM. Post puncture vial was stored in a container to protect from the light and kept in the fridge. All  4 doses administered on 13Jun2022 at 11:24 AM, 12:30 PM, 1:30 PM, 3:00 PM. Vial did not undergo any temperature excursions.Total amount of time the vial was exposed to room temperature range (8 degree to 25 degree C = 46 degree to 77 degree F) was Approximately 5 times, but did not reported a exact amount of time. Vial was not exposed to room temperature for more than 24 hours. It was unknown that Patient was experiencing any symptoms.  No treatment medications were reported.
Tongue numbness; Jaw muscle pain; Lower abdominal pain; Headache; Fever with tachycardia; Flu like symptoms.
Thirty minutes post vax, pt developed facial swelling and hives. She was referred to ER and treated with Prelone and Benadryl.
Patient got the flu shot at around 11am on 12/17/18. By 130pm he was having terrible behavior changes. (He does have preexisting behavior diagnosis that he takes medicine for) we were at a restaurant and he was trying to put a toy together and became so enraged that he threw it down. I threw it away then he proceeded to go into a rage biting me hitting and kicking me trying to throw the chair and table slapped my phone out of my hand. This behavior is not normal for him and prior to this he had an almost perfect day. Then the next day he is fine normal and happy and all the sudden starts raging and body slamming his back pack on the couch .. after it was over he was calm and normal. These events are not his normal behavior. Also on 12/18/18 I noticed a large red hot area on his right arm where he got the flu shot. Up until now I am pretty sure he has always had the preservative free prefilled syringes but this one was not it was in a regular syringe. I am unsure of the make or lot number or anything.
Tested positive for COVID-19 after fully vaccinated. Received 1st dose on 3/26/21 and 2nd dose on 4/21/21.
it's not as itchy as before; it is still red; She also reports that redness also started at the same time; She started with itching at the injection site within few hours after receiving 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (it's not as itchy as before), ERYTHEMA (it is still red), VACCINATION SITE ERYTHEMA (She also reports that redness also started at the same time) and VACCINATION SITE PRURITUS (She started with itching at the injection site within few hours after receiving 1st dose) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  The patient's past medical history included No adverse event.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced VACCINATION SITE ERYTHEMA (She also reports that redness also started at the same time) and VACCINATION SITE PRURITUS (She started with itching at the injection site within few hours after receiving 1st dose). On 26-Apr-2021, the patient experienced PRURITUS (it's not as itchy as before) and ERYTHEMA (it is still red). At the time of the report, PRURITUS (it's not as itchy as before), ERYTHEMA (it is still red), VACCINATION SITE ERYTHEMA (She also reports that redness also started at the same time) and VACCINATION SITE PRURITUS (She started with itching at the injection site within few hours after receiving 1st dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication includes allergic medicines No Treatment information was reported.
Stinging rash on face, head, arms, and torso. Sweating and dizziness followed by fainting. Took Benadryl and went to  Urgent Care, continued with chills.  Was instructed to take claritin, drink water, and go to ED if further problems. Symtoms abated.
she can hardly get around; joint pain; has pains in the muscles above knees on the thigh on both legs and arm from elbow to shoulders / pains in the arm; muscle pain/has pains in the muscles above knees on the thigh on both legs and arm from elbow to shoulders; weak; dizzy; This is a spontaneous report received from Pfizer medical information team from a contactable consumer (patient) that reported.  A 63 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 22Jul2021 (Batch/Lot number: unknown) at the age of 63 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "arthritis" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Administration site: left arm), administration date: 30Jun2021, when the patient was 63 years old, for COVID-19 IMMUNIZATION, reaction(s): "nauseous", "left arm was hurting", "arm was red", "headaches", "hardly walk", "she was weak", "fatigue", "sleep all the time", "memory problems", "lymph nodes on the left side were swollen", "red streak down the middle of her cheek", "phlegm", "terrible tasting", "eyes hurt", "red ring around her eyes.", "hearing was gone", "thrush infection", "stomach was hurting"; Swine flu vaccine (when she was about 22 years old), when the patient was 22 years old, reaction(s): "vomiting". The following information was reported: DIZZINESS (non-serious) with onset Jul2021, outcome "not recovered", described as "dizzy"; GAIT DISTURBANCE (non-serious) with onset 22Jul2021, outcome "unknown", described as "she can hardly get around"; ARTHRALGIA (non-serious) with onset 22Jul2021, outcome "not recovered", described as "joint pain"; PAIN IN EXTREMITY (non-serious) with onset Jul2021, outcome "not recovered", described as "has pains in the muscles above knees on the thigh on both legs and arm from elbow to shoulders / pains in the arm"; MYALGIA (non-serious) with onset Jul2021, outcome "not recovered", described as "muscle pain/has pains in the muscles above knees on the thigh on both legs and arm from elbow to shoulders"; ASTHENIA (non-serious) with onset Jul2021, outcome "not recovered", described as "weak". Therapeutic measures were taken as a result of dizziness, gait disturbance, arthralgia, pain in extremity, myalgia, asthenia.  Additional information: Patient did not had any prior vaccination within 4 weeks. Patient did not had Emergency Room. Patient had Physician Office visit.  Follow-up (12Nov2021): 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 completed. No further information is expected.
Information has been received from a physician concerning a 12 year old male who was vaccinated with a dose of varicella virus vaccine live. On 06/29/2005 the patient experienced breakthrough varicella with 20 lesion and a fever of 101 degrees. Unspecified medical attention was sought. No product quality complaint was involved. The patient is recovering. No additional information was provided.
didn't feel good overall; was shaky; fever; chills; very tired; headache; This spontaneous case was reported by an other health care professional and describes the occurrence of MALAISE (didn't feel good overall), TREMOR (was shaky), PYREXIA (fever), CHILLS (chills) and FATIGUE (very tired) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Seasonal allergy. Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Seasonal allergy, OMEPRAZOLE for an unknown indication.   On 24-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Dec-2020, the patient experienced MALAISE (didn't feel good overall), TREMOR (was shaky), PYREXIA (fever), CHILLS (chills), FATIGUE (very tired) and HEADACHE (headache). At the time of the report, MALAISE (didn't feel good overall), TREMOR (was shaky), PYREXIA (fever), CHILLS (chills), FATIGUE (very tired) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.   This case was linked to MOD-2021-402910, MOD-2021-403241 (Patient Link).
I experienced stress and tightness in chest. Something that I  would describe as a "blip" or a skip. and some labored breathing. This began while I was at altitude on vacation. When I returned I got a referral from my PCP for a cardiologist. After Visit, Dr. Prescribed a CT scan. Scan revealed some small calcium deposits on the left side of my heart. Wore a heart monitor, experienced a "blip" while wearing. They told me it did register but it was just a normal I was prescribed a statin and a baby aspirin. told I could return to regular exercise carefully. I have returned to exercise and am scheduled for a follow up next month.
This non-serious medically confirmed report (initial receipt 13-Oct-2014) concerns a female patient. On the 13-Oct-2014, the patient received AFLURIA multi-dose vial (batch number not reported) for the prevention of influenza. The patient believed that during the administration, she did not receive all of the vaccine dosage because she felt the back of her arm and her skin felt wet. The patient was fine. Outcome was not reported.
Mom reported that patient developed nasal congestion, redness, swelling and itching around eyes about 13:30 on 11/4/20. The above vaccines were administered 10:10 that morning morning. Pt was brought to the ER at 2:00.  ER provider evaluated her and stated possible reaction to vaccines but not an allergic reaction. Pt was discharged home.
ARM ACHED ON DAY OF SHOT, WENT AWAY FOR A COUPLE OF DAYS THEN ACHE CAME BACK
pt came to office 14FEB95 for immunization; pt died 22FEB95 dx sid;
Patient feels radiating pain from deltoid muscle to hands. Which has limit mobility of her arm. It had lasted for almost 3 weeks from date of injection.
Pt reports chest pain COVID vaccine from 02/25/2021 and had symptoms since then.
Feeling painful, burning, itching, redness and swelling at the injection site. Patient is taking the antibiotic, but the swelling area is getting larger. Patient will see her doctor again.
Pfizer-BioNTech COVID-19 Vaccine EUA Developed a swollen gland on the left side of neck, headache and runny nose.
COPD; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID.  A male patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Batch/Lot number: unknown) for immunisation; for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHRONIC OBSTRUCTIVE PULMONARY DISEASE (non-serious), outcome "unknown", described as "COPD".  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v, rsv vaccine prot.subunit pref 2v  has been requested and will be submitted if and when received.
pediatric patient / received engerix-b and Havrix adult doses; pediatric patient / received engerix-b and Havrix adult doses; This case was reported by a nurse via call center representative and described the occurrence of overdose in a 8-year-old male patient who received HAV (Havrix) (batch number G99R4, expiry date 31st May 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Havrix and Havrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced overdose and adult product administered to child. On an unknown date, the outcome of the overdose and adult product administered to child were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The nurse informed that, the pediatric patient received Havrix adult dose, which led to overdose and adult product administered to child. The reporter consented to follow up. This case was patient linked with US2021167000, for the same patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021167000:same reporter
I had a swollen lump at the back of my arm; Pain and swollen area in my Lymph nodes/swollen lymph nodes; Swelling and soreness to the back of the arm that was injected; Swelling and soreness to the back of the arm that was injected; Pain and swollen area in my Lymph nodes; This is a spontaneous report from a contactable consumer (patient). A 71-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: unspecified), via an unspecified route of administration on 26Apr2021 (at the age of 71-years-old) as a dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient received the first dose of the Pfizer Covid vaccine on 26Apr2021, was complaining of swelling and soreness to the back of the arm that was injected, which began a week after the vaccine (May2021). Had been taking Advil and used Hydrocortisone, as well as applying ice. Patient also experienced swollen lymph nodes (May2021) (lymphadenopathy), which generally resolved within 10 days, was likely to have resulted from a robust vaccine-elicited immune response. She wanted to ask if, she should proceed with her second vaccine shot on 16May2021. Patient further stated, she got her first Pfizer shot (COVID Vaccine) on April26 and about 10days later (May2021) she had a swollen lump at the back of her arm where the shot was given up at the top of arm in the back swollen lump and she had been putting ice on it for a few days and taking Advil and she did not know what that was. She needed to know if she could still get her second shot. Patient took Tylenol 500 mg once a day for the pain and swollen area in her lymph nodes and she took 2 Advil may be in 3 days and the Advil then she knew was 200 mg each. She had not taken anything in 24 hours. Therapeutic measures were taken as a result of i had a swollen lump at the back of my arm (limb mass), swelling and soreness to the back of the arm that was injected (vaccination site swelling), swelling, Pain and swollen area in my Lymph nodes (lymph node pain), Pain and swollen area in my Lymph nodes/swollen lymph nodes (swollen lymph nodes) and soreness to the back of the arm that was injected (vaccination site pain). The clinical outcome for the events was unknown except recovered for pain and swollen area in my Lymph nodes/swollen lymph nodes on an unspecified date in May2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
pt recvd vax & 7 days later, devel a fever, malaise & soft stools;
Thinks his gout is starting to act up; This is a spontaneous report from a contactable consumer (patient's wife). A male patient of an unspecified age received second dose of bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot number and Expiration date: unknown), via an unknown route of administration on 05Feb2021 as 2nd dose, unknown for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient previously took first dose of bnt162b2 and had no reaction. On an unknown date, patient's wife thinks that her husband's gout is starting to act up. She called to ask is it ok to take his gout medication Colchicine which is an anti-inflammatory medication. She was just curious whether the Colchicine would interact with the Pfizer covid-19 vaccine or not. She saw that Colchicine is being used experimentally as a treatment for covid-19, so it seems there is some kind of interaction. The clinical outcome of thinks his gout is starting to act up were unknown.  Follow-up attempts are completed. Information on the lot/batch number has been requested. No further information is expected.
Approximately 30 minutes post vaccination, he developed a constant cough. I checked on him and he had a new rash on his abdomen, and flushing to cheeks. Called the pediatrician office and a nurse answered the phone, I described his symptoms and she told me "allergic reaction is impossible after vaccines, if you feel he is possibly having an allergic reaction to something he ate, take him to emergency room". He had not eaten anything after leaving pediatrician office. These symptoms continued for 1 week, then he developed a new rash all over his entire body and a high fever that lasted for about a week.
9/20/2022 I started getting a dry cough, my chest started hurting and felt like I had a real bad cold. I called my doctor and had an appointment. She checked my lungs and said I sounded like I had bronchitis. I had blood test done and it showed I had mycoplasma.  She prescribed cough medicine ( unknown ) and an antibiotic (unknown).  I felt a little better. Two weeks later ,I got sick again with the same thing. I had bloodwork done again which showed mycoplasma. I was given an antibiotic and cough medicine, (unknown). I got better. After that, every week I feel like I have a cold. It comes and goes and I am still going through that.
pain in entire arm. Aggravated by movement. Has tried antiinflammatories and PT w/o improvement. Is currently being referred for further evaluation.
Fever; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) and HEADACHE (Headache) in an 82-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 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.  On 10-Feb-2021, the patient experienced PYREXIA (Fever) and HEADACHE (Headache). At the time of the report, PYREXIA (Fever) and HEADACHE (Headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No corrective treatment and concomitant medications was reported There is no product complaint associated with this case
This is a spontaneous report obtained from a contactable nurse through a Pfizer sales representative. This nurse reported similar event for 3 patients. This is the first of three reports. A patient of an unspecified age, gender and ethnicity received PREVENAR 13, via an unspecified route of administration, on an unspecified date, single dose, for immunization. The patient medical history and the patient's concomitant medications were not reported. The patient experienced pain redness and swelling at the site of injection. The patient recovered from the events at time of this report. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2017006206 Same reporter/drug/AE, different patients;US-PFIZER INC-2017006205 Same reporter/drug/AE, different patients.
I have had a continual headache and pressure in head since vaccine, I take medication for headache but doesn't go all the way away. This reoccurs daily. I also have neck pain in muscles . and my hip and knee joints hurt and are stiff making it difficult to get out of seated position or walk at first.
Patient was under the age of 18 at time of vaccination. No adverse results have been reported by patient.
Muscle aches; Fatigue; General pain at the site of injection; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Muscle aches), FATIGUE (Fatigue) and VACCINATION SITE PAIN (General pain at the site of injection) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) 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 MYALGIA (Muscle aches), FATIGUE (Fatigue) and VACCINATION SITE PAIN (General pain at the site of injection). At the time of the report, MYALGIA (Muscle aches), FATIGUE (Fatigue) and VACCINATION SITE PAIN (General pain at the site of injection) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product use was provided by the reporter. No treatment medication was provided.