chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Tested positive for COVID-19; Tested positive for COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old male patient received BNT162b2 (BNT162B2), on 18Jul2022 at 12:00 as dose 4 (booster), single (Lot number: FW1331) at the age of 60 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 18Jul2022, outcome "unknown", COVID-19 (medically significant) with onset 18Jul2022, outcome "recovered" (04Aug2022) and all described as "Tested positive for COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (18Jul2022) Positive, notes: I tested positive for COVID 19 via an antigen rapid test on 18Jul2022 at 4 pm; (23Jul2022) Positive, notes: I tested positive again on 23Jul; (02Aug2022) Positive, notes: I took an antigen rapid test on 01Aug at 1 am and tested positive; (03Aug2022) Positive, notes: A follow-up test on 03Aug resulted in a positive test; (04Aug2022) Negative, notes: By 04Aug I tested negative. Therapeutic measures were taken as a result of covid-19.  Clinical course: Patient not received other medication in 2 weeks. Patient tested positive for COVID 19 via an antigen rapid test on 18Jul2022 at 4 pm. Within 3 hours patient began a 5 -day period of taking Paxlovid. After 5 days of isolation and feeling nearly completely symptom free patient tested positive again on 23Jul2022 (day 5 following the first positive test. On 30Jul patient experienced symptoms of a head-cold. Patient received no treatment for AE. When this did not improve patient took an antigen rapid test on 02Aug at 1 am and tested positive. A follow-up test on 03Aug resulted in a positive test. By 04Aug patient tested negative. No known allergies was reported.
Tested positive; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive) 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 April 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2022, the patient experienced COVID-19 (Tested positive). At the time of the report, COVID-19 (Tested positive) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test: negative (Negative) Negative and negative (Negative) Negative. In January 2022, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medication were reported. It was reported that the patient continued to work around people who were turning up sick, and tested negative twice in 2021. The patient tested positive on Jan-2022, because of a major uptake among the employees, and 3.5 Days later, was improving without medical intervention.  Company Comment: This is a spontaneous case concerning a patient of unknown age and gender, with no relevant medical history, who experienced the unexpected, non-serious, AESI event of COVID-19. The event occurred 9 months after an unknown dose of mRNA-1273 vaccine administered on an unknown date in Apr-21 for the indication of COVID-19 vaccination. SARS-CoV-2 test done on two unknown dates in 2021 was negative and that done on an unknown date in Jan-22 was positive. At the time of report outcome of the event was Resolving. Further details about the event are not provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a patient of unknown age and gender, with no relevant medical history, who experienced the unexpected, non-serious, AESI event of COVID-19. The event occurred 9 months after an unknown dose of mRNA-1273 vaccine administered on an unknown date in Apr-21 for the indication of COVID-19 vaccination. SARS-CoV-2 test done on two unknown dates in 2021 was negative and that done on an unknown date in Jan-22 was positive. At the time of report outcome of the event was Resolving. Further details about the event are not provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 51-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles. Concomitant products included gabapentin and trazodone. On an unknown date, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm, fatigue, headache and fever. On an unknown date, the outcome of the pain in arm, fatigue, headache and fever were recovered/resolved. The reporter considered the pain in arm, fatigue, headache and fever to be almost certainly related to SHINGRIX. Additional details were provided as follows: The patient was administered SHINGRIX in the right arm and she experienced sore arm, fatigue, headache, and fever which lasted for total of 4 days. No further details were provided. For tolerance to the 2nd dose of Shingrix vaccine, refer case US2018106404 for same patient.
Chills Body Aches Nausea Flu-like symptoms Patient described adverse events lasted approximately one day
After receiving the vaccination, when I stood up I felt a rush to my head. I went to sit in the waiting area to be monitored and my tongue and lip started itching. I then started w/ a red rash to the R side of my neck. My body started to itch all over.  I was brought into a treatment room and my vital signs were being taken when I started to have an increase in coughing, shortness of breath and vomiting. I was given an epipen and brought to the emergency room when I received Benadryl 50mg IV, Solumedrol 125mg IV, and Pepcid 20mg IV. Approximately 1 hour after receiving the medication my face again began to itch and I was given an additional dose of 25mg of Benadryl. My reaction resolved and I was discharged home with a prescription for prednisone.
Started saturday May 1st with the basic "vaccine arm" pain... Today is wednesday May 5 and It STILL hurts really bad. Nothing with injection site, no other side effects... I did have severe arm pain on day 2 of 2nd dose along with chills, fatigue and brain fog  which all subsided on day 3... This pain in my arm is JUST like the pain i had with the 2nd dose... I couldnt have slept on it wrong because i sleep on my right side and this is my left arm and i have a bad back so i know for certain that i didnt over exhurt myself because i literally am very limited to what i can do physically. I have no other explanation for this pain and the vaccine is the only thing i can think of since it mirrors the same exact pain... But why so much later??? Maybe you guys know?
Became lightheaded and nauseated. Patient remained seated. Head between legs. Deep breathing. Gave water and lollypop.
Patient reports red splotches, itchiness, achiness, and callous at injection site that started after vaccine administration and lasted for over 1 week. Patient had not used any treatment and was instructed to take Benadryl and follow up with primary care provider.
JOHNSON & JOHNSON COVID-19 VACCINE, BOOSTER DOSE RECIEVED 12/15/21, PATIENT ADMITTED TO HOSPITAL 12/17/21 WITH BILATERAL PULMONARY EMBOLISMS IN ALL LOBES AND DVT IN LEFT PERONEAL VEIN
Pt reports significant frontal headache beginning day of vaccination [12/14/09] lasting approx 3 days.
Headache, Arthralgia, Back pain, nausea, vomitting ,sensation of fogginess Narrative:
Received vaccine 12/6/16 no adverse symptoms or events until 12/7/16 at 0515 while pt in shower. Pt began to feel lightheaded, dizzy, (+) blurred vision. About 30 sec couldn't see. No LOC. Hit head (right side). Frontal H/A rates 2/10. Negative for N/V.
Left arm weakness; Unable to flex wrist or fingers; This is a spontaneous report from a contactable physician. A 71-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (at 71 years of age),  intramuscular, administered in arm left on 20Apr2021 (Batch/Lot Number: ER8731) as 1st dose, single for COVID-19 immunisation.  Medical history included anxiety, hyperlipidaemia, depression and hypertension, all from an unknown date and unknown if ongoing. The patient had no known allergies. The patient's concomitant medications were not reported. The patient had not received any other vaccine within four weeks prior covid-19 vaccine. He had no covid-19 prior to vaccination. He had not been tested for covid-19 post vaccination. The patient was taking Legendz, Powerful enhanced energy, and Horny goat weed. On 21Apr2021, the patient experienced left arm weakness, unable to flex wrist or fingers. The events resulted to doctor or other healthcare professional office/clinic visit. The patient was admitted to the hospital for the events. Therapeutic measures were taken as a result of the events. The outcome of the events was not recovered.  Information on lot/batch number was available. Additional information has been requested.
The patient walked back in to the provider area and fell in the hallway. The patient  was breathing with a pulse but was unresponsive for about 10 seconds. The patient then began to wake up and respond to questions. EMS was called initially when the patient was noted to be unconcious. The patient began answereing question and explaining tha the felt light headed and was sweating and wanted to come back in the hallway because he "didn't want to cause a scene in the lobby." The patient was noted to have mild sanguinous drainage on the right forehead around his temple. EMS arrived and assessed the patient and took vita signs. The local EMS took the patient to local emergency department to be evaluated. The patient left in stable condition.
Shot given on 02/02/2021.  On 02/10/2021 large area around injection site became red, itchy, and swollen.  Site is also painful and warm to the touch.
Patient has syncopal episode on 7/10 began "foaming at the mouth" and vomiting. was brought in to the hospital and intubated briefly.  Six days later came back to the hospital for right sided weakness and dizziness that led to a fall. Patient was found to have a pericardial effusion on 7/16 that led to a cardiac tamponade and ultimately cardiac arrest on 7/21.
became deaf in one hair; became extraordinarily sick; This is a spontaneous report from a contactable consumer reported for his wife. A 72-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Historical vaccine included polio vaccination at six years of age for immunization. Patient was to receive second dose on 26Mar2021. She had a concern with polio vaccination at six years of age. She went to get her teeth cleaned and the dentist reported that his wife became extraordinarily sick, became deaf in one hair. Had spoken to HCP. She was asking if there was a website that she can search adverse reactions. Outcome of events was unknown.  Information on the lot/batch number has been requested.
Blood clot during menstrual cycle; This is a spontaneous report from a contactable consumer, the patient. A 29-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 10Apr2021 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. Medical history was reported as none. The patient did not receive any medication within two weeks of vaccination. The patient had no allergies to medications, food, or other products. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19.  Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 14May2021, the patient experienced blood clot during menstrual cycle. Therapeutic measures were not taken as a result of the event. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event blood clot during menstrual cycle was unknown at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.  Amendment: This follow-up report is being submitted to amend previously reported information: Patient last name updated, patient Email Address added in patient tab, "No further information is expected." was deleted from final sentence.
Initial misuse report received from a healthcare professional on 16 April 2013. ACTHIB was inadvertently reconstituted with sterile water and administered to a patient (no information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
Patient was given wrong vaccine. Consented for the high dose flu shot and a pfizer booster. Pneumovax was stored in the flu vaccine box for transport and not verified prior to administration.
Lip swelling - at first later - ant neck skin rash & edematous skin in area.
Pt had site reaction with redness starting 2 days after shot. 1 pustule formed 10 days after shot. Patient had itching in area and no other complaints. Saw MD at office on 10-25-13 said minor site reaction and prescribed KEFLEX 500 qid and BACTROBAN ointment to be used if pustule opened.
left fingers felt cold and numb slightly light headed Felt 'goofy' and headache  still feeling the same today - did register for V-safe
Within a couple of days of having vaccination on June 11, 2021, felt weak and ill. this continued to get worse over the next two weeks, and on June 27, 2021, experienced severe back and chest pains requiring medical attention at ER. Heart Cath Test resulted in two arteries completely blocked requiring stints and two arties ~40% blocked. Then over the next 6 months continued experiencing weakness and on February 2, 2022, experienced severe chest pains resulting in seeking medical attention at ER. A heart cath was performed and discovered the two stints placed ~7 months prior had completely blocked again and the other two arteries that were 40% blocked were now 100% blocked. Between June 2021 until February 2022 I was prescribed two blood thinners, cholesterol, blood pressure medicine. February 11, 2022, underwent quadruple by-pass (CABG). since the surgery, I was prescribed two blood thinners, cholesterol, blood pressure medicine. Since the surgery, the first 4-5 weeks felt reasonably well considering the surgery then started  experiencing severe weakness and exhaustion again.
Suspected vaccination failure; I had the shots and still got them; painful,; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: I had the shots and still got them) and pain (Verbatim: painful,). The outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not reported.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and pain to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 11-JUL-2023 This case was reported by patient via interactive digital media. The patient reported that he or she received Shingles vaccine shots and still got them. The patient states that his/her doctor said she had seen much worse, glad the patient got the shots. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. Follow up was not possible, as no contact details were available.
pt recvd vax; exp soreness, weakness & redness at inject site & swelling & numbness in arm where vax given;also exp sl fever
Several vaccines given on 1/13/2012 at 3pm on 1/14/12 (L) thigh, v. red swollen, hard, & hot - approx 5 cm x 4 cm. (R) thigh 1 1/2 cm dia red, firm, hot, swollen area.
I had severe chills, even though I was under an electric blanket I was constantly trembling.  About 4 hours after that I had severe headache and fever.
Patient complained of arm pain that had a rash developed, possibly* from the Pneumovax shot she received on her right arm. Patient had received flu vaccines before with no issue but not sure which type of flu shot.
Triggered a migraine headache from night of injection, off and on through today 3/29. Sore arm the day after but has since gone away. Fatigue/tiredness for the first 24hr after injection.
sister was able to schedule an appointment online at vaccinateri.org for the patient. Patient was administered the first dose of the Moderna vaccine and he is under the age of 18.  He was informed that he wasn't supposed to receive the vaccine because he is under 18 after the fact. Sister reported the incident to the state Department of health and was told to schedule a second dose and report the incident to vaers.hhs,gov
I went to my doctor's office and she was concerned about the size of my stomach and how hard it was; therefore, she immediately sent me to the ER. She could see that I was in quite a bit of pain and discomfort. Emergency room personnel examined me and the ER doctor prescribed a stool softener to clear the contents of my stomach.
"Within hours" post vax, this pt experienced arm pain, her fingers contracted, and she experienced weakness and spasticity. No treatment was given. Symptoms resolved 2 days. As of 08/17/00, the outcome is resolved.
This spontaneous report as received from a registered nurse refers to an unknown number of patients of unspecified demographics. The pertinent medical history was not reported. The nurse reported that since an unknown date in February 2015, the patients were vaccinated with RECOMBIVAX HB, intramuscular which underwent a supported temperature excursion. The concomitant medications were not reported. No adverse events were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Tender, warm, red 3x 6 cm reaction at site of Varivax #2; 48 hr after vaccine administration.
Fever of 101.2; Headache; This is a spontaneous report from a contactable consumer(parent). A 15-years-old female patient received bnt162b2 (BNT162B2, Solution for injection, Lot Number: FA7485), dose 1 via an unspecified route of administration on 29Jul2021 14:30 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient (reporter's daughter) got her first Pfizer yesterday afternoon around 2:30 and on 30Jul2021 she had fever of 101.2 and she got a headache. The patient underwent lab tests and procedures which included body temperature: 101.2 on 30Jul2021. She did not have prior vaccination within four weeks. The outcome for the events was unknown.  Follow-up attempts are completed. No further information is expected.
pain in arm/ muscle part of them was her shoulder blades around her whole arm and upper arm, her shoulder blade up to her neck and right, she thought that was like in the muscle and part of the bone; pain in arm/ muscle part of them was her shoulder blades around her whole arm and upper arm, her shoulder blade up to her neck and right, she thought that was like in the muscle and part of the bone; pain in arm/ muscle part of them was her shoulder blades around her whole arm and upper arm, her shoulder blade up to her neck and right, she thought that was like in the muscle and part of the bone; pain in arm/ muscle part of them was her shoulder blades around her whole arm and upper arm, her shoulder blade up to her neck and right, she thought that was like in the muscle and part of the bone; tenderness and soreness in bone, area around her shoulder blade and in muscle; This is a spontaneous report received from a contactable consumer. The reporter is the patient.  A 73-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), intramuscular, administered in the left arm, administration date 23Feb2021 (Lot number: EN6200) at the age of 73 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "asthma" (unspecified if ongoing); "diabetic" (unspecified if ongoing); "acid reflux" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing). Concomitant medications included: METFORMIN, GLIPIZIDE all taken for diabetes mellitus. The following information was reported: PAIN IN EXTREMITY (non-serious), MYALGIA (non-serious), NECK PAIN (non-serious), BONE PAIN (non-serious) all with onset 25Feb2021, outcome "unknown" and all described as "pain in arm/ muscle part of them was her shoulder blades around her whole arm and upper arm, her shoulder blade up to her neck and right, she thought that was like in the muscle and part of the bone"; MUSCULOSKELETAL PAIN (non-serious) with onset 25Feb2021, outcome "unknown", described as "tenderness and soreness in bone, area around her shoulder blade and in muscle".  Additional information: The patient reported that she was taking 3 medications, but only two drugs were reported. She also mentioned that the event start date might be about 25Feb2021. The patient wanted to know if the second shot is advised to get in the same (site) where she got in the first one.   No follow-up attempts are possible. No further information is expected.
No signs or symptoms reported; a temperature excursion; This spontaneous report was received from an office manager referring to a patient of unknown age and gender. Information about medical history, concurrent conditions and concomitant therapies was not provided.   On 07-JUL-2021, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) (lot # T032318, expiration date 22-SEP-2022, 1 dosage form) for prophylaxis (product storage error). Temperature excursions were 15 Fahrenheit degree to 46 Fahrenheit degree (30.3 Fahrenheit degree) for 6 hours 30 minutes and 0 seconds; 6 Fahrenheit degree to 14 Fahrenheit degree (14.1 Fahrenheit degree) for 5 hours 0 minutes and 0 seconds; 15 Fahrenheit degree to 46 Fahrenheit degree (16.6 Fahrenheit degree) for 14 hours 0 minutes and 0 seconds; 15 Fahrenheit degree to 46 Fahrenheit degree (19.7 Fahrenheit degree) for 1 hour 0 minutes and 0 seconds. Time frame 26 Hours 30 Minutes 0 Seconds (cumulative). There was no previous temperature excursion. Data logger was involved. No signs or symptoms were reported.
Very red, sore, hot reaction over four inches from left arm site of injection. Trouble breathing. Dr said possible infection but three friends had same exact reaction after taking vac from same location.
VACCINE WAS NOT DILUTED CORRECTLY (WAS <1.8ML OF DILUANT) AND PT GOT CONCENTRATED DOSE OF PFIZER COVID VACCINE. PT HAD NO AEs 30 MIN AFTER VACCINE WAS ADMINISTERED. 2 DAYS LATER, ONLY AEs WAS SORE ARM.