chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt experienced arm pain and shoulder pain after injection - near inj site. Started days after inj; con't for ~ 2 months. It cleared but shortly thereafter pt has experienced nerve pain distally in the area - in hand laterally & forearm - non localizable on NOS - ulnar sensory neuropathy per neuro.
Headache; fever; chills; sore arm at injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 10 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 29Nov2021 14:30 (Lot number: Fk5618) at the age of 10 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FLU, start date: 15Nov2021, stop date: 15Nov2021. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Fk5127, Location of injection: Arm Left, Vaccine Administration Time: 02:30 PM), administration date: 08Nov2021, when the patient was 10 years old, for Covid-19 immunization, reaction(s): "Sore arm". The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 29Nov2021 21:00, outcome "recovered" (2021), described as "sore arm at injection site"; HEADACHE (non-serious) with onset 30Nov2021, outcome "recovered" (2021), described as "Headache"; PYREXIA (non-serious) with onset 30Nov2021, outcome "recovered" (2021), described as "fever"; CHILLS (non-serious) with onset 30Nov2021, outcome "recovered" (2021), described as "chills". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of vaccination site pain, headache, pyrexia, chills.  Additional information: Event of sore arm at injection site and headache (mild) had occurred 6-8 hours after second dose and fever, chills and headache (moderate) had occurred 12 hours after second dose. Patient was treated with motrin and tylenol. Patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Patient received a total of 4 doses of the Moderna vaccine. He received 2 doses at a pharmacy on 4/1/21 and 5/1/21. He then received 2 doses of the Moderna vaccine at our pharmacy on 5/25/21 and 7/9/21. He stated on his intake form from 5/25/21  that he had not received any COVID vaccines and since his first 2 were in the STATE, they did not show on allertiis. Insurance covered the dose on 5/25/21, but declined the dose on 7/9/21. When we called insurance and that is how we discovered he received 4 doses. After speaking with the patient he intentionally sought out how to obtain a third dose and got the fourth dose as to not raise suspicion. He also stated he did this so he could be in the Oregon vaccine lottery.  After questioning on any adverse events, he stated he only experienced a sore arm for a few days.
Information has been received from a physician referring to a patient of unknown age and gender. The patient's medical history, concomitant therapy and concurrent condition were not provided. On 22-JUN-2016, the patient was vaccinated with a dose of M-M-R II (dose, route, lot number and expiration date were unknown), which experienced temperature excursion. The patient wanted to check a titer for M-M-R II. This is one of several reports that received from the same source. Additional information has been requested.
Developed redness, swelling, heat lt upper arm to shoulder.  Has had fever since  100-101 degrees.  Saw Dr. at Clinic on 4/16/03
A non-serious spontaneous report of pneumonia has been received from a registered nurse concerning her eight-year-old son, subsequent to FLUMIST. The patient's past medical history included meconium aspiration and pneumonia at three-years-old. The patient received FLUMIST in Oct-2008. In Nov-2008, the patient developed pneumonia which was treated with antibiotics. The event resolved two weeks after the onset. The reporter was not sure if the event was related to FLUMIST.
12:45 Post vaccination reports episode of nausea; medical monitoring x 30 min w/no additional symptoms noted or complaints; vitals assessed, BP 116/81 P79 ; released from facility home
received Adacel at the age of 9; Initial information received on 02-Jul-2019 regarding an unsolicited valid non-serious case received from a physician.  This case involves a nine years old patient (gender not reported) who was vaccinated with a dose of vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] lot number, Exp. Date, dose, route and site of administration not reported on an unknown date.  The patient's past vaccination(s) included MENINGOCOCCAL VACCINE received at age of 2 years, 5 years and 8 years and DAPTACEL for immunization. Concomitant medications not reported.  It was an actual medication error case due to inappropriate age at vaccine administration.  It was unknown whether the patient experienced any adverse event post vaccination.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested.  List of documents held by sender: none.
Abdominal pain; diarrhoea; This is a spontaneous report from a non-contactable other health care professional. A 49-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 and dose 2; via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Abdominal pain and diarrhoea one day after receiving vaccine. This happened after each dose. The outcome of the events was unknown.  No follow up attempts are possible. Information about Lot/batch number cannot be obtained.
got the Pfizer booster; got the Pfizer booster; Lymphedema; Swelling; This is a spontaneous report from a non-contactable physician (patient). A patient of unspecified age and gender received bnt162b2 (BNT162B2), dose 3 via an unspecified route of administration, administered in arm on 21Aug2021 (Batch/Lot number was not reported) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation. Medical history included breast cancer (had a cancer diagnosis and had breast cancer and had gone through radiation), radiation/radiation therapy, surgery/one node that had been taken out and got a sentinel node, just one node biopsy for the 'surveillance notes' on the same arm. The patient's concomitant medications were not reported. Reportedly, the patient got the Pfizer booster on 21Aug2021 because the patient had a cancer diagnosis and had breast cancer and had gone through radiation. The patient was about to start a ARIMIDEX for oral chemotherapy and that's why the patient got the booster. So, after the patient got the injection, in 2021, the patient got swelling and then lymphedema which the patient didn't get before, even after surgery and after radiation therapy. The patient asked was that vaccine still effective because lymphedema lasted (the patient got the injection on 21Aug2021 and it was still, the swelling was just starting to go down, a little bit) and after speaking with the surgeon there was a question for the patient that the patient had, the patient did not have axillary node complete dissection, just had one node that had been taken out with no lymphedema noted after surgery (further clarification unknown). So, the patient especially being a physician, asked was the vaccine still effective when the patient got all that swelling. The patient had got a sentinel node, just one node biopsy for the 'surveillance notes' on the same arm and that was where the patient got the injection (further clarification unknown). So, the patient was trying to get advice. Outcome for swelling was recovering; lymphedema was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient underage with current EUA. Mother presented with client and sibling. Mother reported to administrating nurse on 2 occasions that client was 16 and sibling was 17 yo. On documentation of administration, it was realized that child is 14 yo. Patient has no noted adverse effects. Patient not scheduled for 2nd dose at this time.
Pt had aches and fever, then developed rash on arm on 6/14/2017.
Left arm pain; Headache after waking up the following morning; Chills; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 11May2021 at 16:00 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. Medical history included C6/C7 spinal cord injury and lactose allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 20Apr2021 at 16:00 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. On 12May2021 at 06:30, the patient experienced left arm pain, headache after waked up the following morning and chills. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of events and included treatment with ibuprofen on an unknown date. The clinical outcome of the events left arm pain, headache after waking up the following morning and chills was resolving at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient passed away on 2/2/21 after being admitted on 1/31/21 after receiving COVID19 Moderna Vaccine on 1/26/21. On initial report to the hospital patient reported having a cough for over 2 weeks (starting approx. 1/17/21). He had a postive COVID19 PCR on 1/31/21. Intubated on 1/31/21 and passed away on 2/2/21
I was hesitant to get this 3rd dose because I had a severe adverse reaction to my 2nd Moderna dose; But since I have a compromised immune system I was encouraged to get it; I still had a small protrusion on my right arm that remained after my doctor removed a swollen lymph node; I chose to get this 3rd dose in my right arm as well because I didn't want to jeopardize anything going wrong with my left arm; After the vaccination a bump appeared on the red spot and it became bigger and scaly looking over the next couple of days; I went to a Dermatologist and a biopsy was done, but it came back inconclusive; I have an appointment to go back for more testing and they may choose to remove it.
I got shingles after getting the shingles vaccine/ Suspected vaccination failure; I got shingles after getting the shingles vaccine; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient had reported the case for himself/herself. The age at vaccination was not reported. The age group was not reported but was captured as an adult as per vaccine indication.  The patient got shingles after getting the shingles vaccine. The reporter declined an offer for the current shingles vaccine. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. This case was one of the 16 cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR088502:Same reporter US-GLAXOSMITHKLINE-US2021AMR088503:Same reporter US-GLAXOSMITHKLINE-US2021AMR088504:Same reporter US-GLAXOSMITHKLINE-US2021AMR088497:Same reporter US-GLAXOSMITHKLINE-US2021AMR088498:Same reporter US-GLAXOSMITHKLINE-US2021AMR088499:Same reporter US-GLAXOSMITHKLINE-US2021AMR088500:Same reporter US-GLAXOSMITHKLINE-US2021AMR088501:Same reporter US-GLAXOSMITHKLINE-US2021AMR088505:Same reporter US-GLAXOSMITHKLINE-US2021AMR088506:Same reporter US-GLAXOSMITHKLINE-US2021AMR088507:Same reporter US-GLAXOSMITHKLINE-US2021AMR088496:Same reporter US-GLAXOSMITHKLINE-US2021AMR088494:Same reporter US-GLAXOSMITHKLINE-US2021AMR088495:Same reporter US-GLAXOSMITHKLINE-US2021AMR088531:Same reporter
-No symptoms at time of administer -7 hours later had soreness in arm -20 hours later dizziness, full body aches, chills, fever, headache, fatigue, upper GI problems
Narrative:  77 yr-old male patient found unresponsive by wife in late evening of 2/26/21 (2 days following 2nd Moderna dose). Wife performed CPR until emergency help arrived however patient did not survive and was declared deceased on 2/27/21 at1212. Per death certificate, immediate cause of death "myocardial infarction" followed by longstanding of Afib and COPD. No autopsy reported. Of note, no ADR reported following 1st Moderna dose on 1/28/21.
This case was reported by a physician, via a GSK sales representative, that described the occurrence of injection site hot to touch in four child subjects of unspecified genders who were vaccinated with INFANRIX (GlaxoSmithKline). On an unspecified date (s), the subjects received either their 4th or their 5th dose of INFANRIX (.5 ml, unknown). Within 24 hours after vaccination with INFANRIX, the subjects experienced injection site that was hot to the touch, and swelling at the injection site. The physician's office reported that at least four child subjects experienced the same type of reaction to a particular lot of INFANRIX (Lot #AC14B085BA). Product complaints were lodged for these reports, as the physician's office was concerned that this was a potentially a bad lot of INFANRIX. At the time of reporting, the outcome of the events was unspecified. The physician considered the events were probably related to vaccination with INFANRIX. Follow-up information received on 07 October 2008 indicated that the subject was a 4 year old female. Topical reaction was documented with the onset of events provided as 04 September 2008. The events resolved on an unspecified date in September 2008. In the reporter's opinion, the events were possibly related to treatment with INFANRIX. This was the subject's 5th dose of INFANRIX. In follow-up a 5th case was reported. Linked cases include: A0747167A, A0747168A, A0747169A and A0752555A. A safety statement received on 19 October 2008 concluded that there was no evidence for a safety signal or safety concern for the INFANRIX lot AC14B085BA.
28APR98 mom states lt deltoid (DTAP) was red, hot w/large knot & rt deltoid (MMR) had small bumps all over site, only 4-5 1-2mm diameter bumps;c/o itch;entire lt deltoid swollen;
While waiting 15 minutes in waiting room after vaccines were given. Pt said he didn't feel well and collapsed into arms of corpman. He was carried to gurney to rest for 30 minutes.
pt recv vax 10AUG94 & 11AUG94 pt exp fever of 101, h/a, insomnia, tiredness, malaise, weakness, & crying; tx Ibuprofen & bed rest for 48 hr;
Patient received the vaccines and states that later that afternoon her arm was swollen, warm, and red to touch. She happened to fall that afternoon requiring a visit to the hospital for a broken wrist and the patient states the hospital told her it was infected. She also stated that when she got to the hospital they diagnosed her with a urinary tract infection and pneumonia. She indicated on our questionnaire that she was not ill and did not have a fever. She stated that the hospital had her on antibiotics for the UTI, pneumonia and her swollen arm.
This case was reported by a consumer and described the occurrence of neuralgia-trigeminal in a female patient who received VERAMYST aqueous spray for an unknown drug indication. A physician or other health care professional has not verified this report. On 2007 the patient started Fluticasone furoate (each nostril/both nostrils), unknown dosing. At an unknown time after starting Fluticasone furoate, the patient experienced neuralgia-trigeminal and facial pain. The patient was treated with NEURONTIN. At the time of reporting, the outcome of the events was unknown. The patient said she used VERAMYST since it was marketed (2007) and wondered if there could be a relation between it and the trigeminal pain she has on her cheek along the side of the nose and centers around the sinus area. She asked if there had been any reports like this with VERAMYST. Follow up information received from the patient on 03 January 2011. The patient provided the lot number for the product. The patient reported that on an unspecified date, about two to three weeks before the events occurred, she also had a flu shot (details unknown, unspecified manufacturer). The patient stated that she did not think that VERAMYST caused any problems and that she was only inquiring if there were any other reports of trigeminal neuralgia. Follow-up information was received on 27 January 2011. It was reported that the subject was a 64 year old female. Event onset was 08 November 2010. At the time of reporting, the events were improved. Attribution of events to treatment with VERAMYST and the flu shot was unknown. In the reporter's opinion, the events may have been idiopathic. Medical history included diabetes mellitus type 2, hypertension and hypothyroidism. There was no history of alcohol or tobacco use.
Pain injection site.  In morning, abdominal bloating/distention and abdominal discomfort. Feeling unwell.
Systemic: Headache-Severe, Systemic: Visual Changes/Disturbances-Medium
This case was reported by a consumer via call center representative and described the occurrence of swelling arm in a 75-year-old female patient who received SHINGRIX for prophylaxis. On 10th December 2018, the patient received the 1st dose of SHINGRIX. On 10th December 2018, less than a day after receiving SHINGRIX, the patient experienced swelling arm and erythema of extremities. On an unknown date, the outcome of the swelling arm and erythema of extremities were unknown. It was unknown if the reporter considered the swelling arm and erythema of extremities to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in left arm on the same day evening she had arm swelling and redness. She notes the swelling almost was the size of another muscle. She was encouraged to share this with her physician, she stated she did with the pharmacist and they referred her to GSK. She noticed the swelling makes it hard to lay on that side and arm. The reporter gave consent to follow up.
Tingling and numbness in cheeks/nose, swelling of face after 30 minutes. Within 24 hours adverse symptoms appeared - sore arm, extreme fatigue and nausea. Additional allergy symptoms appeared within 24 to 48 hours - throat tightness, sinus inflammation and ears itching.
had three cancers; two strokes; she had COVID in early Jun; she had COVID in early Jun; lung infection; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:. The reporter is the patient.  A female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose number unknown, 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: PNEUMONIA (medically significant) with onset 2023, outcome "unknown", described as "lung infection"; DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Jun2023, outcome "unknown" and all described as "she had COVID in early Jun"; NEOPLASM MALIGNANT (medically significant), outcome "unknown", described as "had three cancers"; CEREBROVASCULAR ACCIDENT (medically significant), outcome "unknown", described as "two strokes". The event "lung infection" required physician office visit. Clinical course: Reporter mentioned that she tried to get the new COVID vaccine for a long time and her local pharmacy said they think they cannot get any that they only had Moderna. Her doctor had said to get the shot from Pfizer which is preferred just when she had all the other shots. She added she have been to pharmacies and frustrated because she had COVID in early Jun, had three cancers, two strokes but still functioning beautifully, she further said right now she have a lung infection and the doctor wants her to get the shot but cant find one any help at all.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient got  covid vaccine by his troop (military), unknown which brand, dx with pericarditis after he returned back in country, diagnosed on east coast at military facility
Left Arm: 8cm in size, red in color (localized) at injection site. Warmth, erythema, swelling and tenderness and no fluctuance.  Treated with Bactrim DS 800 mg-160mg twice daily
Narrative: Patient reported to the clinic nurse on 4/26/2021 "After my second Pfizer Vaccine on March 16, 2021 my Walking has been getting worst. My Thighs cramps all the time and stiff. No problems with my Calves. Lost of mobility. I am not falling and I do not use a Walker or a Cane. Pain level when at its worst is 8-9/10."" Patient was seen by primary care physician on 5/10/21 with persisting symptoms and was sent home with methylprednisolone dose pack myalgias.
Mother stated, child got blister at site where he got vaccine. Later had hives on body. She took him to ER. and was given Rx of steroids and BENADRYL. Is a little better today. But still has hives. Appt sch to see Dr 6/7/12 at 1 pm.
Headache, body (muscle) aches, stuffy head, runny nose, itchy/burning eyes, low grade fever, fatigue/lethargy, mild nausea, colon cramps.    Symptoms were not severe.  I just wanted to make you aware of them, since I understand that it is rare to have symptoms after the first dose (which this was).   I was not in any place or around any people to be exposed to a oold or flu virus.
Opposite (right) arm (forearm) started to have pain. It has continued all the way to the 2nd vaccination on May 13. On May 14, after 2nd shot (on left upper arm again), the right wrist started to hurt on the next day. Just seems like a strange coincidence. I can deal with it. I'm hoping it goes away eventually.
Sternum rebound tenderness.  Severe Chest pain in the center of chest wall. Shortness of breath Dizziness Pounding Heart rate and Tachycardia