chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Unresponsive; A spontaneous report was received from Pfizer concerning a 56-year old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and had a sudden death.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 08 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (lot/batch:  unknown)  for prophylaxis of COVID-19 infection.  On 09 Jan 2021, the patient was found deceased in her home. No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not applicable.   The patient died on 09 Jan 2021. The cause of death was not provided/unknown. Plans for an autopsy were unknown/not provided.; Reporter's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.; Reported Cause(s) of Death: unknown cause of death
Fever, chills, nausea, muscle aches, headache, redness swelling at injection site 3 inches in diameter
Information has been received from a health professional concerning a 4 year old white male with no known allergies or medical history who on 04/06/2001 was vaccinated subcutaneously with a first dose of varicella virus vaccine live.  Concomitant vaccinations on 04/06/2001 included a third dose intramuscularly of Hepatitis B virus vaccine rHBsAG.  There was no illness at the time of vaccination.  On approximately 02/01/2005, in the first week of February 2005, the patient experienced a very mild case of chickenpox.  Unspecified medical attention was sought and the patient is recovering.  No product quality complaint was involved.  Follow up information has been received from a health professional indicating that the child developed mild varicella disease with less than 50 pox on 02/04/2005.  It was noted that several children at the school had it at the same time.  No labs or diagnostic tests were done.  The child recovered on 02/16/2005.  The patient's brother also experienced a mild case of chickenpox after vaccination with varicella virus vaccine live.  No additional information is expected.
weakness, myalgia, short of breath, abdominal pain, diarrhea + COVID test
Pt states that the day of vaccine she got a rash on her arm and redness at injection site. She states that rash spread and has since resolved some. When she came in today, she showed me the arm where she has some slight redness. She states it did not itch, burn, or swell and it wasn't uncomfortable. She did not seek medical attention and did not apply any creams or treatment to area.
August 17 2021-Woke up at 5 AM had some pressure in my head that I had never noticed before. Then I noticed some edema on both sides of my neck and felt a swollen lymph node on the right side of my neck. I was scheduled for my yearly mammogram today so I called and ask if I should still get it she advised me no because I had the vaccine and that would make the results of my mammogram abnormal and I should wait until 4-6 weeks following my second dose of the vaccine. I got concerned regarding the edema on both sides of my neck and the pressure I was feeling in my head, I called my PCP and made an appointment for this afternoon. He was very concerned due to the large amount of edema on my neck he ordered a series of labs, soft neck ultrasound and a IM injection of Decadron. Also gave me a prescription of Decadron. He advised me if any of my symptoms get worse he was sending me to the ED for further treatment. Also advised me to not take the 2nd dose of the vaccine. I came over to the hospital got my prescription filled, labs and ultrasound of the neck done.  August 18th I stayed home resting still having pressure in my head and edema in my neck. I?m taking the Decadron as directed and this is helping with the pressure in my head and neck.  August 19, 2021 I returned to work. I?m feeling better only have the edema in my neck and feel a little more tired than usual.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Nausea-Mild, Systemic: Weakness-Mild, Additional Details: Patient was having eye/visual complaint before administering Pfizer vaccine.  After administering Pfizer vaccine, patient stated she feels dizzy, nauseated, and weakness.  Followed protocol, monitoring patient, advised district leader, and called 911
Red lump on the back of left arm and has been ill for the last 2 days with fever up to 104. Taking Motrin. Diabetes out of control. Advised by MD to take aspirin, fluids, IV hydration was offered due to vomiting.
Normal pain and weakness the day of vaccination, and the next 2 days. pain went away for 3-4 days, then came back 9/17/20.  Pain/ weakness in right arm/shoulder. Weakness / limited range of motion in right arm for 3 weeks after shot administered. Could not lift  arm full for over 3 weeks straight due to weakness. Severe pain when crossing arm in front of body.
Dizziness, minor swelling and redness, had provider look at "dime size" area and provider stated it could have been foliculitis.
At post vaccination day number 5, began experiencing excruciating left hip pain radiating into the lower back and groin.  These symptoms were nearly relieved before receiving a second dose when the symptoms suddenly and immediately arose again.
I received my third shot booster on 3-3-22 at local store. On Friday morning 3-4-22 when I got up I had body aches and took 2 Ibuprofen tablets, these did no good at all. I had chills all day. I ended up leaving work around 12:30p.m. I felt so bad with the body aches and chills. Ended up taking 2 Tylenols which after 1 hour helped me feel better.
Chronic urticaria occurring approximately 10 days after 3rd dose of moderna vaccine. Urticaria flares would happen multiple times a day for approximately 30 minutes with itching. Randomly appear anywhere on the body. Symptoms relieved with daily Claritin. Discontinued Claritin after 5 weeks. Urticaria symptoms were greatly lessened, but present for 1 more week. Mostly resolved now with a minor itch here and there without a flare of urticaria.
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. Other Case identifier(s): US-PFIZER INC-202101440587 (Pfizer). A 43 year-old female patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 22Oct2021 (Batch/Lot number: unknown) at the age of 43 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "immunocompromised" (unspecified if ongoing). Concomitant medication(s) included: HUMIRA (ongoing); CELEXA (ongoing); SYNTHROID (ongoing); BUSPIRONE (ongoing); ZYRTEC ALLERGY (ongoing). Vaccination history included: Bnt162b2 (1st dose), for COVID-19 immunization; Bnt162b2 (2nd dose), for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 22Oct2021, outcome "unknown", described as "Booster"; AXILLARY PAIN (non-serious) with onset Oct2021, outcome "not recovered", described as "she had pain under the arm pits/experienced a significant pain under her armpit"; SLEEP DISORDER (non-serious) with onset Oct2021, outcome "unknown", described as "persisted Saturday night and kept her up that night". It was unknown if therapeutic measures were taken as a result of axillary pain.Additional Information: Follow up attempts are completed, No further information is expected.No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt received flu shot the day prior, on 10/23.  It seemed more likely the SHINGRIX would have given her the reaction as she was tolerating the flu shot for a day, plus she has had flu shots, FLUCELVAX specifically, before.  The pt said she came home from work sunday evening and noticed her body and back and part of throat were covered in small bumps, she was bright red like a sunburn, but had no itching, no swelling, no tenderness, no pain. It was only on her trunk, not on her arms or legs or face.  To our knowledge she has had no treatment. Left message with pt's Dr, no response yet.
Doctor cancelled her appointment for second dose; tested positive; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive) and OFF LABEL USE (Doctor cancelled her appointment for second dose) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025120A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced COVID-19 (tested positive). On an unknown date, the patient experienced OFF LABEL USE (Doctor cancelled her appointment for second dose). The patient was treated with MONOCLONAL ANTIBODY 17-1A ongoing since an unknown date for Adverse event, at a dose of UNK dosage form. At the time of the report, COVID-19 (tested positive) outcome was unknown and OFF LABEL USE (Doctor cancelled her appointment for second dose) had resolved.        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.   The patient went to emergency room  on 02-Feb-2021 and received the monoclonal antibody infusion.
No adverse reaction, patient was to receive DTap-Hep B-IPV vaccine and was given DTap-Hib-IPV vaccine, no treatment needed, mother was notified of the incident, states no reactions.
2/18/2021: Lost complete ability to smell anything within 24 hours of receiving the vaccination - as of today, 6/28/2022, I still cannot smell anything 2/18/2021: I had sharp chest pains when drawing a breath and shortness of breath until 9/21/2021
brain fog; body aches; headache; nausea; heavy fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (brain fog), PAIN (body aches), HEADACHE (headache), NAUSEA (nausea) and FATIGUE (heavy fatigue) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination.     The patient's past medical history included SARS-CoV-2 infection in July 2020.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced FEELING ABNORMAL (brain fog), PAIN (body aches), HEADACHE (headache), NAUSEA (nausea) and FATIGUE (heavy fatigue). On 07-Apr-2021 at 6:00 PM, FEELING ABNORMAL (brain fog), PAIN (body aches), HEADACHE (headache), NAUSEA (nausea) and FATIGUE (heavy fatigue) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In July 2020, SARS-CoV-2 test: Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications was reported Treatment information was not provided Action taken with mRNA-1273 in response to the event was unknown
Daptacel expired on the 23Oct2019 and was administered to a patient on 24Oct2019 with no ae; Initial information received on 21-Oct-2019 regarding an unsolicited valid non-serious case received from a consume.   This case involves a 6 years old female patient who received DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (lot no: C507AA Expiry date: 23-Oct-2019 ) via Intramuscular route in right Thigh on 24-Oct-2019.   The past medical history, medical treatment(s), vaccination(s) and family history were not provided.  The past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error due to Expired product administered. It was reported that Daptacel expired on the 23Oct2019 and was administered to a patient on 24Oct2019, with no adverse event   At the time of reporting, the patient had no adverse event.   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.
Swollen painful lump under my arm has formed that also itches.  It is the size of a tennis ball. I also had injection site pain as well as body aches and a migraine like headache.   I am on the 3rd day of the swollen underarm.  All other symptoms have resolved.
high fever, fatigue, body ache for 48 hours severe headache lasting  more than 2 weeks brain fog over 1 month chronic hip joint pain onset within 24 hours of injection and continuing.
Severe vomiting for 24 hours; to the point we almost took him to er for dehydration. Hadn?t urinated in 12 hours;  no other symptoms;  (except for the expected exhaustion, stomach pain from vomiting)
Patient came to pharmacy on 12/22/2007 to receive flu shot.  Patient contacted pharmacy on 12/27/2007 with report of hives from flu shot.  Patient wasn't initially going to let us know about the reaction, so patient was not upset in any way whatsoever about the reaction.
Occipital Nerve Damage; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of occipital neuralgia 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 occipital neuralgia (Verbatim: Occipital Nerve Damage). The outcome of the occipital neuralgia was not reported.   It was unknown if the reporter considered the occipital neuralgia to be related to Shingles vaccine.     It was unknown if the company considered the occipital neuralgia to be related to Shingles vaccine.   Additional Information: GSK receipt date: 03-MAR-2023 This case was reported bya patient via interactive digital media. The patient had ocipital nerve damage from Shingles vaccine. The follow-up could not be possible as no contact details were available.
After four days of getting the vaccine, on 4/10/21, I had strong a strong smell of a combination of metallic, vinegar and distilled alcohol smell that overpowered everything that I smelled and tasted. This was happening throughout the day and continued for about a week. After about a week the smell decreased and my sense of taste started to improve. As of 4/30/21 the worst time of this occurring  smell & taste was in the morning and occasionally during the day. Today, 5/5/21, with reduced adverse effects, I received my second Covid-19 vaccination. Nothing has changed as of four hours after this second shot.
temp of 101.7, chills, headache, nausea, vomiting diarrhea
Had Moderna 1st shot on Jan 7. Eye infection that night and the next day. Then, Saturday the 16th, a tickle in my chest.. soon produced a dry cough in relief/response to the tickle. Next day, I was hoarse (Sunday the 17th). Still hoarse. Sore throat off and on. Headache. Body aches. Incredible arthritis-like ache at the tops of my shoulders, upper back, and neck. Runny nose. Spitting mucous - was clear, now some thick solid white. Chest pain in the middle that comes and goes. Chest pain on left center side - it feels like in the area of my heart. Ache in my lower left side. Today, aching in my jaws mostly left side, but both. Ache on upper right front (lung area?). INCREDIBLY tired. It's so hard to stay awake.
pt co rapid heart rate, upper lip and nose numbness and tingling, lightheadedness and shaking.  pt given 1 dose of 0.3 EpiPen to right thigh.  symptoms progressed to feeling a lump in her throat and chest pressure.  initial vital signs were BP 178/83, HR 124, res 24, and 02 sats of 97%.  Held 2nd epi dose because HR increased to 146, BP 206/85.  911 activated, pt transported to ED
patient returned to the lobby area and begin to turn pale and fainted briefly but came back to consciousness quickly  and complained of blurred vision in the left eye and ringing in ears. patient was given cold water while awaiting service from EMS that was called by the pharmacy department. patients' color came back and EMS checked the patient vitals.
This spontaneous report was received from a physician, referring to an unspecified number of patients. Concomitant medications were not provided. The patients were vaccinated with unknown doses of GARDASIL 9, intramuscularly (lot # and expiration date not reported) for prevention of HPV on an unspecified dates. On the same date of vaccination, the patients' experienced head lag, were unresponsive and had mental status changes. Also the had seizures. During the seizures, the patients' whole faces turned white, their lips turned blue, and they started to make a groaning sound and seemed like they were awake but were not able to comprehend anything or communicate (cognitive disorder) (communication disorder). Furthermore, the patients' experienced decreased blood pressure.  The outcome of the events was not provided. The reporter considered seizures to be a life threatening.  The causal relationship between vaccination with GARDASIL 9 and the events was not provided.  This is one of two reports received from the same source.
received only first in June 2018; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose (0.5 ml) intramuscularly on unknown arm, in June 2018).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 01-NOV-2022 Reporter's Comments: The reporter reported that one of her patients received only the first Shingrix.  The reporter would give her the second Shingrix vaccine on the day of reporting per CDC (Centers for Disease Control and Prevention) guidelines. The reporter did not consent to follow-up.  Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix vaccine, which led to incomplete course of vaccination.
tested positive for COVID-19; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program. A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 22Mar2021 (Lot Number: ER8732, unknown expiration) as a single dose for COVID-19 immunisation.  The patient's medical history and concomitant medications were not reported.  The patient received his first COVID vaccine dose on 22Mar2021 and then tested positive for COVID-19 on 29Mar2021 with symptoms for 14 days. The patient supposed to get the second dose on 19Apr2021.  The patient was told to have a COVID-19 test before he can receive the second dose. He has been symptom-free for more than fourteen days and would like to know if there would be any issues with taking the second dose after developing COVID-19. The patient recovered from the event on unspecified date in 2021.   No follow-up attempts are possible. No further information is expected.
COVID-19; abscess under arms; anxiety; Depression; Weight loss; COVID-19; Vaccination site pain; Feeling of weakness after vaccines; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4257003-00.  A 29 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 25Mar2021 (Batch/Lot number: unknown) at the age of 28 years as dose 1, single and intramuscular, administration date 15Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) as unk (citrate free) for psoriasis, hidradenitis. Relevant medical history included: "covid", start date: 2019 (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant) with onset 21Dec2021, outcome "recovered" and all described as "COVID-19"; SUBCUTANEOUS ABSCESS (non-serious), outcome "unknown", described as "abscess under arms"; VACCINATION SITE PAIN (non-serious) with onset 2021, outcome "unknown", described as "Vaccination site pain"; ASTHENIA (non-serious) with onset 2021, outcome "unknown", described as "Feeling of weakness after vaccines"; ANXIETY (non-serious), outcome "recovering", described as "anxiety"; DEPRESSION (non-serious), outcome "recovering", described as "Depression"; WEIGHT DECREASED (non-serious), outcome "unknown", described as "Weight loss". The patient underwent the following laboratory tests and procedures: weight: lost nine. The action taken for adalimumab was unknown. Therapeutic measures were taken as a result of subcutaneous abscess.   The reporter's assessment of the causal relationship of the event Vaccination site pain with the suspect product was possible and for other events of the causal relationship was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine cannot be excluded for the reported events of Drug ineffective, COVID-19, subcutaneous abscess, vaccination site pain, Asthenia, anxiety, Depression, and weight decreased.
I received the booster on Tuesday, December 21, 2021. I woke up Wednesday to from red spots on my right and left arm. I also noticed one on my left hip. As of now, they do not hurt or itch.
This is a spontaneous report from a contactable consumer. A 41-year-old (non-pregnant) female patient received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, lot# EL9264), at vaccination age of 41, via an unspecified route of administration, left arm, on Feb 9, 2021, single dose, for COVID-19 immunisation. Medical history included ongoing hypertension, ongoing asthma (under control). Patient has known allergies to penicillin, from an unknown date and unknown if ongoing. There were no concomitant medications. Patient previously took the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, lot# EJ1686), at vaccination age of 41, via an unspecified route of administration, left arm, on Jan 19, 2021, at 11:00 am, single dose, for COVID-19 immunisation. On Feb 10, 2021, at 07:00, patient experienced headache, chills, nausea, vomiting, general body pain (lung; back pain) when breathing, with outcome of not recovered. Follow-up attempts completed. No further information expected.
I was shaking and had a fever of 101.7. I developed tremors in my hands, legs, and face. I could barely walk, eat, or hold a fork properly. I went into the ER and my heart rate was at 142. I still had a fever, which lasted for 4 days. The tremors continued for 5 weeks. I have seen my Primary Care doctor multiple times and I have taken numerous of tests.  I still have tremors. They have not gone away. They come & go and show up at random times.