chrisvoncsefalvay/vaers-outcomes huggingface dataset:
17 year old received first dose; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old received first dose) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 069H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Jan-2022, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old received first dose). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old received first dose) outcome was unknown.        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.   Concomitant medications were not reported.   On 09-Feb-2022, received second dose of vaccine (lot number: 022J21A).  Treatment medications were not reported.
No symptoms for about 3 days, then 24 hours of nausea, severe headache, fatigue and muscle aches.  Symptoms lasted about 24 hours then I was fine.
Patient developed significant right deltoid pain making it difficult to do daily tasks and move arm. The pain has persisted for 3 and a half weeks so far, and is still ongoing, though it is starting to improve.
Rash on arm of injection site; non-itchy, non-painful; Over the course of 3 weeks appeared more bruise-like; This is a spontaneous report from a contactable consumer (patient). An adult female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 05Mar2021 (Lot number and expiration date was not reported) as dose 1, single for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. The patient experienced rash on arm of injection site; non-itchy, non-painful, over the course of 3 weeks appeared more bruise-like on 05Mar2021. The patient did not receive treatment for the events. The outcome of events was recovering.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Symptoms began the day after the injection was received. Symptoms included: high fever (103 degrees), nausea, lightneadedness (almost passed out twice), uncontrollable chills (whole bed was shaking), night sweats, headache, mental fogginess.   The day after the injection I developed a UTI; was put on macrobid antibiotic.  Shortness of breath began on day 3 after the injection.  Difficulty breathing; out of breath going up the steps.  Went to the ER on day 4 after the injection with all the symptoms listed above.
1st day - Nothing.   2nd day - Extreme Fatigue, Rash and Itching on Chest, Sharp Pains in Heart, Sore Throat  (It's now 5 days and still having periodic sharp pains in heart and throat still hurts)
The night after I received my first dose, my tinnitus has gotten very loud, to the point where I find it hard to sleep or function. That started on 04/09/2021 and still just as loud on 04/17/2021
Sore arm, hot to touch onset 3 hours after injection. 100.3 degree fever onset 19 hours after injection.
Drug Allergies: Iodine, Pneumonia Vaccine; swelling; This is a spontaneous report from a Pfizer sponsored program. A contactable physician reported that a 77-year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) via an unspecified route of administration on an unspecified date at single dose for pneumonia vaccine and iodine via an unspecified route of administration on an unspecified date at an unspecified dose and frequency for an unspecified indication. Relevant medical history and concomitant medications were not reported. On an unspecified date, the patient experienced drug allergies  and swelling. The action taken in response to the events for iodine was unknown. The outcome of the events was unknown.  The information on the batch number has been requested.  Pfizer is a Marketing Authorization Holder of pneumococcal 13-val conj vac (dipht crm197 protein) in the country of incidence. This may be a duplicate report if another Marketing Authorization Holder of pneumococcal 13-val conj vac (dipht crm197 protein) has submitted the same report to the regulatory authorities.
Although I'm 50 and age-wise, due to have hot flashes, I had not had them in months, especially since I started losing weight from May 2020 through September 2020.  (total of 20lbs). A few days after getting 1st dose the hot flashes have been relentless; Internal hot flashes literally every 5-10m, daily, consistently throughout the day, even as I fill out this report. Not sure if the dose has anything to do with this starting up again, but I wanted to report it just in case some others report it.  I do not take anything for the flashes. I just seek some form of air conditioning such as a fan. However, the flashes are very annoying as I even get them while sleeping and it interrupts my rest. No sweating though.
nausea, need to urinate, blood in urine, headache, backache, neckache, heart rate greater than 100
end up getting the flu every time I get the shot; Initial information received on 07-Dec-2020 regarding an unsolicited valid non-serious case from a patient.  This case involves a patient of unknown age who had flu (influenza), after the patient received Influenza Vaccine.  The patient's medical treatment(s), vaccination(s), concomitant medications and family history were not provided. At the time of the event, the patient had ongoing Autoimmune disorder.  On an unknown date, the patient received an unknown dose of suspect influenza vaccine produced by unknown manufacturer (lot number, route, administration site and expiry date unknown).    On an unknown date, the patient had flu (influenza), (unknown latency) following the administration of influenza vaccine.   No relevant laboratory test was reported.  It was not reported if the patient received any corrective treatment.  The event outcome was unknown.  There will be no information available on the batch number for this case.
>> May 20, 2021  9:32 AM someone wrote: Pt is requesting an appt and/or phone call ASAP Pt states he received his first dose of the Covid vaccine on Wednesday, 5/18, and ever since, he has had fever, headache, skin hurting, loss of appetite, general weakness and pain, dry mouth, congestion and at first had a cough, but that has subsided. Office Visit 5/20/2021 Family Medicine   MD Family Medicine Suspected 2019 novel coronavirus infection Dx Acute Symptoms  Reason for Visit Office Visit 5/25/2021 Family Medicine  MD Family Medicine Shortness of breath +2 more Dx Cough  Reason for Visit Progress Notes MD (Physician) ? ? Family Medicine ? ? Encounter Date: 5/25/2021 ? ? Signed Expand AllCollapse All    Chief Complaint Patient presents with ? Cough     Just diagnosed with covid on 5/20.Fever is gone, but is unable to take deep breath, produvtive cough. Denies SOB. Concerned with pneumonia
a lot of symptoms of COVID; a lot of symptoms of COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 55-year-old male patient received BNT162b2 (BNT162B2), in Jun2022 as dose 4 (booster), single (Batch/Lot number: unknown) 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'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 "unknown" and all described as "a lot of symptoms of COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results.  Clinical course: It was reported that the patient had an awful reaction to the 4th vaccine of the Pfizer COVID vaccine back in the beginning of June. He had a lot of symptoms of COVID and an awful rash. His eyes were all swollen, it was a horrible mess. It was told that the 4th booster shot was changed and apparently that was the one that gave him the awful reaction. [After confirming when the bivalent booster dose was authorized] He did not get this recent booster; he got the booster vaccine that came out in about Mar or Apr. He was still dealing with the situation in Nov." Caller inquired if it in the mRNA that was changed for the new booster dose as, also inquired if first 3 doses did not contain this change of the DNA strand of the virus. The date of bivalent Pfizer COVID vaccine was inquired. It was inquired if the mRNA breaks down when the vaccine breaks down or does the mRNA stay in the body forever and how long did the immune system take to produce antibodies or if it would show up in the body.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient states that within 24 hours he started feeling like his bones were on fire and has a red rash all over his body - refused medical treatment
Started to get a rash on my left side. It initially itched and there was no rash, a couple days later there was a rash, a couple days later there were blisters. At this point I thought it was poison oak from a hike I had been on a week prior. A couple days later they started to crust over and it started feeling more painful than itching. Another couple days they started turning into black scabs and all the while it continued to get more painful and I began having stabbing pain in my chest. At this point (after nearly 3 weeks) I searched online to see if there is an correlation between poison oak and nerve pain. That lead me to images of shingles and I KNEW that's what it was. The next day I called urgent care, wno came out and diagnosed me with shingles and prescribed me the antiviral medication Valacyclovir 1gm tablet Q12 hrs x 10 days. I am currently half way through. I am still experiencing the pain of the rash, however the stabbing chest pain seems to have subsided. My blood pressure was 138/86 mm[Hg]. 02 Saturation 97% Room Air at Rest, Temperature 97.9 degrees ear, HR = 76 on 12/4 when I was seen by urgent care.
Redness, itching, raised area. 3.7 x 3.5 cm.
2nd dose hurt, achiness; Low grade fever; Little headache; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain (an unknown date received 1st dose refer case US2022AMR151277).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 1 day after receiving Shingrix, the patient experienced pain, fever and headache. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pain, fever and headache were unknown.   It was unknown if the reporter considered the pain, fever and headache to be related to Shingrix.     Linked case(s) involving the same patient:  US2022AMR151277   Additional Information: GSK Receipt Date: 19-OCT-2022 Reporter's Comments: This case was received from consumer via interactive digital media. The patient received the dose of Shingrix for shingles.  The second dose hurt much worse and next day patient experiencing low grade fever, achiness and little headache. The reporter wanted to know was that normal since patient did not had that the first dose. Additional supportive information: The follow-up could not be possible as no contact details were available.  ; Sender's Comments:  US-GSK-US2022AMR151277:Same reporter
pain problems; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1; Pfizer vaccine.), for COVID-19 immunization. The following information was reported: PAIN (non-serious) with onset Mar2021, outcome "unknown", described as "pain problems".  Additional information: Caller received the second dose of the Pfizer-BioNtech Covid-19 vaccine today, he would like to know if he can take Tylenol for pain problems that are not related to the vaccine. During post-call documentation potential AE was identified. He mentioned that his pain problems were not related to the vaccine, however, he did not mention if his pain problems are prior to the vaccine or if he has been taking Tylenol since before the vaccination.  Follow-up attempts completed. No further information expected.
Arthritis flare up; Dose 1: Moderna, Dose 2: Moderna, Dose: 3: Pfizer; Dose 1: Moderna, Dose 2: Moderna, Dose: 3: Pfizer; Dose received 3; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 79 year-old male patient received bnt162b2 (BNT162B2), administration date 30Nov2021 15:00 (Batch/Lot number: unknown) at the age of 79 years as dose 3 (booster) single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Moderna (Dose Number: 2, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for COVID-19 immunization; Moderna (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for COVID-19 immunization. The following information was reported: ARTHRITIS (disability) with onset 30Nov2021 15:00, outcome "not recovered", described as "Arthritis flare up"; OFF LABEL USE (non-serious), INTERCHANGE OF VACCINE PRODUCTS (non-serious) all with onset 30Nov2021 15:00, outcome "unknown" and all described as "Dose 1: Moderna, Dose 2: Moderna, Dose: 3: Pfizer"; IMMUNISATION (non-serious) with onset 30Nov2021 15:00, outcome "unknown", described as "Dose received 3". Therapeutic measures were not taken as a result of arthritis.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Fever of 100.2-101.1 (axillary), heart rate > 100 all day, palpitations, PVCs, ventricular bigeminy for 20-25 min (verified with ECG app on apple watch). Symptoms started at 4am (almost 12 hours after receiving vaccine) and lasted until I went to bed at 9pm. I took advil throughout the day and when I woke up at 5am Tuesday (36 hours later) I felt completely normal.
Fever - chills and sweating,  severe headache, severe all over muscle aches.
Information has been received concerning a pt who 1 day post vaccination experienced deep muscle pain with some redness across the arm. It was reported that the pt gets some relief by alternating ibuprofen and Tylenol about every 3 hours. The outcome of the redness is unknown. Follow up information said the pt was seen at Dr's office and was grimacing in pain. No significant swelling was noted. No laboratory work was done. Her Dr feels that her arm is sore due to her building up a good immuno response to vaccination.  The pt called and said she was doing great.
no adverse reaction; just given (mistakenly) to an individual that was not 18 at time of vaccine
pt recv vax 26NOV97 & 2JAN98 pt devel moderate chickenpox;
About a week or so after my 2nd vaccine, I began experiencing excrutiating pain radiating down my left arm, should and neck whenever I moved my arm or even slightly rotated it. I'm in constant pain. I went to my primary care physician in September who referred me to physical therapy. I did PT twice a week in October for two weeks at rehab and daily therapy at home for months.  The PT nurse recommended I see an orthopedic surgeon. I saw Dr. at Ortho at the end of October. He gave me a cortisone shot who to help but I am still in constant pain. I own a cleaning business and it's very difficult to use my left arm and the pain has still not gone away. This is affecting my work and day to day functions.
Tested positive for Covid; Tested positive for Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 91 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single 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), COVID-19 (medically significant), outcome "unknown" and all described as "Tested positive for Covid". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive.   The lot number for bnt162b2 was not provided and will be requested during follow up.  Additional information:  Agent relays he has a patient on the line to get advice, she already had dose 1 and 2 and the booster however she was tested positive for Covid. Agent relays she would like advice if she should take another booster shot. Agent relays the caller did not provide name of product. She would like to get advice on what will be the next step to take. She also mentioned that she came home with Her Daughter who was tested negative (patient mentioned) and also has a Son who is staying at a wondering if He is also positive or not. She also mentioned that she is with 2 other adults in the house.
Heart began racing suddenly, to about 120-140 bpm. No shortness of breath, chest pain, sweating or any other symptoms. Lasted approximately 2-3 minutes after which heart rate returned to normal (72-76 bpm).
soreness in left arm at the start and now 1-24-23 having trouble lifting the arm
Swelling & redness at injection site - light headed - Numbness in arm of administration.
This case was reported by a nurse via sales rep and described the occurrence of injection site erythema in a 18-year-old female patient who received BEXSERO. On 8th June 2016, the patient received the 1st dose of BEXSERO (intramuscular) .5ml. In June 2016, less than a week after receiving BEXSERO, the patient experienced injection site erythema and injection site warmth. On an unknown date, the outcome of the injection site erythema and injection site warmth were not recovered/not resolved. The reporter considered the injection site erythema and injection site warmth to be probably related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. The concomitant medications received by the patients were unknown. The patient experienced redness and warmth around the injection site in her arm. In the morning of the reporting date, the patient had called the office for reporting that the injection site was still red and warm.
Left arm pain; Dizziness; Weakness; Nausea; Vomiting; Tiredness; Headache; feeling unwell; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Sep2022 at 17:30 as dose 5 (booster), single (Lot number: GH9694) at the age of 56 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "COVID" (unspecified if ongoing), notes: If COVID prior vaccination: Yes; "HIV Positive" (unspecified if ongoing). Concomitant medication(s) included: DOVATO; ALENDRONATE SODIUM; CALCIUM & VITAMIN D3. Past drug history included: Penicillin (augmentin), reaction(s): "known allergies: Penicillin (Augmentin)". Vaccination history included: BNT162b2 (Dose 4, Batch/Lot No: FM7553, Location of injection: Arm Left), administration date: 19May2022, when the patient was 56-year-old, for COVID-19 Immunization, reaction(s): "left arm pain"; BNT162b2 (Dose 3, Batch/Lot No: EW0185, Location of injection: Arm Left), administration date: 25Aug2021, when the patient was 55-year-old, for COVID-19 Immunization, reaction(s): "left arm pain"; BNT162b2 (Dose 2, Batch/Lot No: ER8731, Location of injection: Arm Left), administration date: 17Apr2021, when the patient was 55-year-old, for COVID-19 Immunization, reaction(s): "left arm pain"; BNT162b2 (Dose 1, Batch/Lot No: ER2613, Location of injection: Arm Left), administration date: 20Mar2021, when the patient was 55-year-old, for COVID-19 Immunization, reaction(s): "left arm pain". The following information was reported: DIZZINESS (non-serious) with onset 13Sep2022 at 09:00, outcome "recovering"; HEADACHE (non-serious) with onset 13Sep2022 at 09:00, outcome "recovering"; PAIN IN EXTREMITY (non-serious) with onset 13Sep2022 at 09:00, outcome "recovering", described as "Left arm pain"; NAUSEA (non-serious) with onset 13Sep2022 at 09:00, outcome "recovering"; FATIGUE (non-serious) with onset 13Sep2022 at 09:00, outcome "recovering", described as "Tiredness"; VOMITING (non-serious) with onset 13Sep2022 at 09:00, outcome "recovering"; ASTHENIA (non-serious) with onset 13Sep2022 at 09:00, outcome "recovering", described as "Weakness"; MALAISE (non-serious) with onset 13Sep2022 at 09:00, outcome "recovering", described as "feeling unwell". Therapeutic measures were not taken as a result of pain in extremity, dizziness, asthenia, nausea, vomiting, fatigue, headache, malaise.  Additional information: It was reported no seriousness criteria that is results in death, life threatening, caused/prolonged hospitalization, disabling/incapacitating, congenital anomaly/birth defect. Also reported left arm pain that evening. Dizziness, weakness, nausea, vomiting, tiredness, headache and feeling unwell started the next day. No reaction other than left arm pain with the first 4 shots. The patient was not COVID tested post vaccination and no other vaccine in four weeks.
Warmth at injection site, local redness, edema, joint pain body aches, hip pain.
02/23/2006 immunization given at clinic.  On 02/24/2006 Mother of child noticed left thigh erythemateous.  02/28/2006 patient seen in clinic given Motrin, ice packs.
On 02-17-2021 I received my second dose and within twenty minutes I felt dizzy, flushed and also felt warm. When I went home, I experienced terrible headache. I rested and took nap for 4 hours. Then when I woke up I started having throbbing pain under my armpit under my left arm. By 09:00pm that night I had swelling under my armpit and on the next morning at my job site (I am a health care nurse) I could not lift a patient. Throughout the day I still felt fatigue, my left arm was killing me and by late morning on the following day, my lymph nodes were huge, grape size and could not put my left arm down at all. I tried to go to work next day use hot compresses to bring my swelling down. I then went to see my doctor, who put me on Cetirizine and ibuprofen 800mg and also gave me medicine for my stomach so I could take the ibuprofen. I was out of work one week. My swelling was awful, I had to brace my lymph node with a pillow because the pain was incredible. The swelling of my lymph node went back for the most part, had minimal swelling. And in May 2021 and I called the on call physical because I had a boil under my left armpit and had to get antibiotics. Now the boils is gone, there is a little scar and there is also just a little lump now that I have.