chrisvoncsefalvay/vaers-outcomes huggingface dataset:
He received his 3rd dose (booster) of his Moderna COVID on 11/29.  The following day, he began feeling mid-sternal chest pain, 7/10, sharp, constant, non-radiating. No other symptoms such as diaphoresis, difficulty breathing, nausea, vomiting, dizziness, syncope, abdominal pain, or rash. He took three 325mg aspirin pills without much relief. Chest pain continued today prompting presentation to the ED. He has not had a recent cold or sickness, and denies known history of personal COVID infection. His father had COVID in August of 2020.
Severe swelling at the injection site, migraine headache, fever chills, body aches and  nausea
Chills; Headaches; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose1, 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: CHILLS (non-serious), outcome "unknown"; HEADACHE (non-serious), outcome "unknown", described as "Headaches".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
The patient passed out about 12 minutes after receiving second dose of Pfizer covid vaccination.  The patient's mother got the attention of the monitoring nursing staff at which time the patient was alert and staff elevated patients lower limbs, checked BP, HR, pulse ox, and provided cold compresses and water for patient.  After about 5 minutes patient also vomited.  The patient was monitored for an additional 20 minutes at which time patient felt better and was able to walk out without assistance.
mom states pt cried since got shots;pt cried for 24hr x/for about 45min;has not even stopped long enough to take a bottle;was told by MD child had gas & was teething;
developed a boil under his arm which is painful/a little boil under the arm where he got the vaccine; developed a boil under his arm which is painful; arm is red; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 46 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 13Aug2021 16:40 (Lot number: FC3181) at the age of 47 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Blood pressure" (unspecified if ongoing); "Pre-diabetes" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN (ongoing); VALSARTAN (ongoing). Vaccination history included: Bnt162b2 (1st dose, Lot number: it is either FA9484 or FA4484, Given in left arm.), administration date: 23Jul2021, when the patient was 46 years old, for Covid-19 Immunization. The following information was reported: VACCINATION SITE REACTION (non-serious) with onset 14Aug2021, outcome "not recovered", described as "developed a boil under his arm which is painful/a little boil under the arm where he got the vaccine"; PAIN (non-serious) with onset 14Aug2021, outcome "unknown", described as "developed a boil under his arm which is painful"; ERYTHEMA (non-serious) with onset 14Aug2021, outcome "not recovered", described as "arm is red".  Additional information: Caller wants to know if we have some information on the reported side effect and if he needs to put a cream on it or take a medicine. Caller also wanted to know if how long will the side effects last. He got his second dose of COVID19 vaccine last Friday. on Saturday he started developing a little boil under the arm where he got the vaccine. It is all covered in red. The boil feel firmer now. It is causing a lot of pain when he lets his arm hang. he took a shower a minute ago and it seems like the red is still there from bicep to chest. Caller clarified it has stayed the same. Pain: it started Saturday night. If it is just hanging there it hurts. When sleeping it causes him to change position because of the pain. Outcome of event: depends on how much pressure he puts on it. The weight of the arm hurts. If he puts more pressure on the pain persist. Saturday he noticed the pain about 12:00. It just started bothering him. By the time he was going to go to sleep the pain was more. Then he looked in the mirror and noticed the redness and the boil. Prior to vaccination, the patient was not diagnosed with COVID-19.   No follow-up attempts are possible. No further information is expected.
Vaginal bleeding; excruciating headache; This is a spontaneous report from a contactable consumer. This 71-year-old female consumer (patient) reported for herself that she received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EN6199, Expiry date: 30Jun2021) via an unspecified route of administration on 04Mar2021 (at the age of 71-year-old) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 07Mar2021, the patient experienced excruciating headache and on 10Mar2021, she experienced vaginal bleeding. She does not think call handler can help, but she had the first dose of the shot and the side effects, aside from what was listed, she has excruciating headache, four to five days after the dose and bleeding, clarified to vaginal bleeding, like menstrual cycle. Both started a few days after the shot. She further clarified and said she got the first dose date of vaccine 04Mar2021 and 3 to 4 days after was when her headache started. She later clarified the excruciating headache started on 07Mar2021. She states the headache was still ongoing. Bleeding started yesterday morning. She states the bleeding was still ongoing. Caller states she will not do the second dose. She said it will kill her. She regrets that she did it because it was unproven. We only know what reactions are today but she does not know what is going to happen to her in the future. Besides it was so frightening. She said she was just rambling right now, maybe in a year or in the fall when they have new stuff coming out, she does not know but it was not proven. Outcome was not resolved for both the events.  No follow up attempts are possible. No further information is expected.
Child claimed injection site was in pain.  Stated, "Hurt a lot" and he had trouble moving arm around. Injection site was swollen, red, and hot to the touch.
Bell's Palsy; Vertigo; face numbness; I also have episodes of excessive sweating and flushing; I also have episodes of excessive sweating and flushing; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41-year-old male patient received BNT162b2 (BNT162B2), on 07Apr2021 as dose 2, single (Lot number: ER8732) at the age of 40 years for covid-19 immunization. The patient's relevant medical history included: "Allergies: Latex" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (prev dose lot number=EN6199, prev dose dose number=1), administration date: 18Mar2021, for COVID-19 Immunization. The following information was reported: BELL'S PALSY (disability, medically significant) with onset 2021, outcome "not recovered"; HYPERHIDROSIS (disability), FLUSHING (disability) all with onset 2021, outcome "not recovered" and all described as "I also have episodes of excessive sweating and flushing"; VERTIGO (disability) with onset 2021, outcome "not recovered"; HYPOAESTHESIA (disability) with onset 2021, outcome "not recovered", described as "face numbness". The events "bell's palsy", "vertigo", "face numbness" and "i also have episodes of excessive sweating and flushing" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: If covid tested post vaccination: Yes. Therapeutic measures were taken as a result of bell's palsy, vertigo, hypoaesthesia, hyperhidrosis, flushing.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200866994 Same patient, different dose and event;US-PFIZER INC-202200864099 Same patient, different dose and event;US-PFIZER INC-202200866994 Same patient, different dose and event;
No adverse event; expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vaccine used) and NO ADVERSE EVENT (No adverse event) in a 51-year-old female patient who received mRNA-1273 (Spikevax) (batch no. O70H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vaccine used). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired vaccine used) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (expired vaccine used).    Concomitant product use was not provided by the reporter. Treatment information was not provided.  ID number was reported as 80777027399.  Patient age was reported as 51 Year 3 Month.  Completion date provided as 28-Apr-2022.   Reportedly, the number of patients at facility that received this Moderna vaccine between 08-Apr-2022 and 15-Dec-2022.
Injections site red, swollen, tender to touch, hot...also same symptoms further down the arm and into the shoulder and arm pit.
My symptoms started on June 20, 2022 with a mild cough and being tired. On June 21, 2022 I had more cough and congestion and very achy, I did an at home COVID-19 test that came back negative. I felt so bad that I went into work and had them do the salvia PCR COVID-19 test that came back positive. My visit told me I did not qualify for the Paxlovid and they recommended over the counter medication for me to take. I feel I have improved but not fully recovereed.
A solicited consumer report has been received via Abbvie. The report concerns a 1 year old male patient whose weight: 9.1 kilograms. Medical history, concurrent diseases and concomitant medications of the patient were not provided. During Oct-2013, intramuscular SYNAGIS was started for intra-atrial communication. Dosing and frequency were not provided. On 29-Oct-2013, the baby's father reported that after having administered the unknown influenza virus vaccine was administered. During Nov-2013, the patient experienced gastroenteritis and vomiting. The baby's father associated the vomiting more to the flu vaccine than to the SYNAGIS. In fact, the baby's mother had also administered the flu vaccine and also had suffered from vomiting. The paediatrician prescribed the baby oral fluids and he told that it was a gastroenteritis. The patient was treated with oral fluids. The patient recovered after few days from the event of gastroenteritis and vomiting. The outcome of the event of flu vaccine given outside the approved age was unknown. Lot number information was not provided. The events of gastroenteritis and vomiting were assessed as non-serious. The event of flu vaccine given outside of approved age was identified from the source document and considered to be non-serious by the company physician. The reporter considered that there was no causality between the events of gastroenteritis and vomiting and the suspected drug of SYNAGIS. The company physician considered that there was no causality between the events of gastroenteritis, vomiting and flu vaccine given outside of approved age and the suspected drug of flu vaccine (unknown). Corrected report 11-Dec-2013: Case was suppressed as non-valid.
her mother bled on the arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE HAEMORRHAGE (her mother bled on the arm) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE HAEMORRHAGE (her mother bled on the arm). At the time of the report, VACCINATION SITE HAEMORRHAGE (her mother bled on the arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant information  provided. No Treatment information  provided   This case was linked to US-MODERNATX, INC.-MOD-2021-077167, MOD-2021-077217 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-077167: MOD-2021-077217:2nd dose US-MODERNATX, INC.-MOD-2021-077217:1st dose
no longer could get an erection; Flu like symptoms; This is a spontaneous report from a contactable consumer (patient himself). A 42-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in the left arm on 24Apr2021 at 09:15 (Batch/Lot number and Expiration date were unknown) as the 2nd dose, single for COVID-19 immunization. The patient previously received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date. The facility where the most recent COVID-19 vaccine was administered was at the pharmacy or drug store. The patient had no medical history. The patient had no known allergies. The patient's 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. Since the vaccination, the patient had not been tested for COVID-19. On 24Apr2021, the patient experienced flu like symptoms. After 48 hours (on 26Apr2021) and when flu like symptoms went away, the patient immediately noticed something else; he no longer could get an erection. He had never had an issue ever in life until 48 hours after his second injection and still 2 weeks later, he could not get an erection, which was considered serious as it resulted in disability. The adverse events (AEs) did result in a doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the AEs. The patient recovered from the event "flu like symptoms" on 26Apr2021, while he was not recovered from the event "no longer could get an erection."  No follow-up attempts are possible, information about batch/lot number cannot be obtained. No further information is expected.
Due to restrictions in the city, we were taking appointments by phone.  Pt came to our store on 3/16/21 and received the first dose of Moderna.  Due to a scheduling error, pt was also scheduled for an appointment on 3/19/21.  It was on 3/19/21 that pt was administered the J&J vaccine.  With the high volume of vaccinations given at our site, billing was behind.  It wasn't until pt returned for his second dose of Moderna that it was discovered he was given both Moderna as well as Janssen.  Pt stated he felt fine and wanted to proceed with his second dose of Moderna, which was denied.
Wrong dose given, should have received the 5-11 year old dose of 10mcg/0.2 ml dose and she was given the 12 year and up dose of 30 mcg/0.3ml dose. No adverse reaction noted.
Dtap # 4 was given at a shorter interval than recommended from Dtap #3 and vaccine will need to be repeated. Parents have been notified.
Systemic: Chills, Systemic: Headache, Systemic: dizziness, bitterness in taste in mouth, shaky, hands cold to touch, high heart rate - 120, BP 154/89
Developed numbness on the right side of her body on 07/13/21. The client's husband stated she woke up with numbness along the right side of her body on 07/13/21. The client went to urgent care and was subsequently admitted to hospital for five days. The client stated she saw two neurologists. One of the neurologists thought her symptoms were related to a stroke, and stated they are currently treating her as if she had a stroke. The client is currently taking Aspirin and Atorvastatin. The client reports persistent numbness along her right side from her knee to her foot, which has improved, but not resolved. The client's husband stated the doctor approved for the client to receive the 2nd dose COVID vaccine Pfizer. The client's husband noted the client was also diagnosed with a "hole in her heart" while in the hospital. The client is scheduled to follow up with a cardiologist tomorrow. The client denied any shortness of breath after receiving the 1st COVID vaccine Pfizer. The client denies any chronic conditions.
Extreme Thrombocytopenia (below 30,000) manifesting in bruising on arms, legs, torso, bleeding gums, bleeding nose.   Was 30,000 at time blood drawn to test... by that point the symptoms were improving, so likely well under 30,000 in prior 1-2 weeks.  Any effect on fetus (20 weeks) still unknown... being evaluated this week.
Large swelling and erythema L upper arm, shoulder with 2-3cm round small vesicles at site of injection.
This spontaneous report was received from a male adult consumer of an unknown age referring to him/herself. Patient's pertinent medical history, drug reactions and allergies were not reported. On unknown date in August 2015 (reported as "about one year ago"), the patient was administered ZOSTAVAX (dose, frequency, route of administration, lot # and expiration date were not provided). Information regarding concomitant therapy was not reported. Approximately on 10-AUG-2016 (reported as "2 weeks ago"), the patient developed shingles on his left torso and he stated that the vaccine worked like a charm. The patient has been self-treating with calamine lotion topically and oatmeal baths. At the time of the reporting, the patient was recovering from the event of shingles reported as his shingles lesions were crusting over. The patient reported that he had appointment scheduled with his physician on 01-SEP-2016. There was no product quality complaint IPQC) involved. Additionally, the reporter did not provide any causal relationship between the event and therapy with ZOSTAVAX. His shingles lesions are crusting over (recovering) but he still has itching and pain. The patient states he has an appointment scheduled with his physician on 01-SEP-2016. Additional information has been requested.
fluttering of the heart; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC FLUTTER (fluttering of the heart) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CARDIAC FLUTTER (fluttering of the heart) (seriousness criterion medically significant). At the time of the report, CARDIAC FLUTTER (fluttering of the heart) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant and Treatment Drug was provided by reporter.   This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company comment.  This spontaneous case concerns a female patient of unknow age, with no reported medical history, who received a dose of mRNA-1273 vaccine  and experienced the serious (medically significant) unexpected AESI of cardiac flutter. Vaccination date and onset date of the event was not provided; hence, latency and temporal association cannot be properly assessed. No further clinical information was available for medical reviewing. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a female patient of unknow age, with no reported medical history, who received a dose of mRNA-1273 vaccine  and experienced the serious (medically significant) unexpected AESI of cardiac flutter. Vaccination date and onset date of the event was not provided; hence, latency and temporal association cannot be properly assessed. No further clinical information was available for medical reviewing. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
15 mo well exam 2/29. Later that night, pt experienced flat rash spots, (R) facial swelling that eventually resolved. Rash came & went. No hives/itching. (+) congestion, R/N, cough. Seen by PCP 3/2 Dx RSV; No rash/swelling noted. C/O wheeze but none on exam.
Patient reports a red band on her arm about 2 inches below injection site. Denies itching or other areas of body affected. Denies trouble breathing, lips swelling, or other symptoms of anaphylaxis.
Headache, left side, behind left eye to back of the head on my left. Alternating between entire rear of head and aforementioned locations with little relief from OTC products. Norco seems to help.
Patient was given Covid Vaccine BUD.  Exp was 7/7/22 and vaccine was given 7/8/22
AFTER I GOT THE VACCINE, On august 04 i started having a pain on my right foot, it was a deep pain that don?t let me walk for about 3 weeks, i went to the foot doctor and they just got a bursitis after i got a MRI. i got steroid on pill and local injection for the pain on my superior side of the foot, but i was able to walk after 4 weeks but the pain started coming up on my leg and my back. i started PT on September 18 for about 6 weeks, the pain didn?t go away, i was not able to drive, but to more but don?t walk for 1 minute. I went to the Neurologists doctor, she did an EMG Test, they found my nerve inflamed, and a possibility of a back problem, started taking gabapentin for a month, didn?t work, then got a MRI and found a budged disc on my L4, L5. continued taking medication, then started seeing a Pain management, who put a steroid injection on November 20. GOT WORST the 1st 2 weeks, then I feel better. but on December 22 I got covid again, and 2 week after covid I got the same pain on my left foot and leg, was not able to walk for 2 days, took pregabalin that my doctor prescribe in case of any pain, and got better after 3 days, after that I have been not able to walk for more than 30 minute at the gym, I cannot dance for more than 5 minutes, and I cant driver more than 25 minute either, if I do something like this for more than that time , I started having pain on my nerves. I also had a stomach ultrasound and pelvis, they found inflation con my liver and found cysts on the ovaries that on 2020 when I got a pelvis ultrasound didn?t have. I also have more pain n my period every month and my immune system is weak I didn?t have any of those problem with my nerve or back before or inflammations, all of this came after vaccine since I got covid on 2020 and didn?t have any of this.