chrisvoncsefalvay/vaers-outcomes huggingface dataset:
swelling larger an egg under armpit; fluid retention at his chest and back for 2 days; face swelled up and got red; face swelled up and got red; around his eyes it's still swollen and flushed red; This is a spontaneous report from a contactable consumer (patient's wife) via medical information team. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration on an unspecified date as a dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration on an unspecified date as a dose 1, single for COVID-19 immunization. Enquired that, the caller was called on behalf of her husband, (name withheld). Stated that, her husband had his second covid vaccine shot and had a strange reaction. Stated that, the patient had swelling larger an egg under armpit, fluid retention at his chest and back for 2 days and the following day face swelled up and got red. Today it has subsided but all around his eyes it's still swollen and flushed red. Asked whether this was normal for people to get after getting the covid vaccine. The caller was asking whether there would be issues if ever her daughter will be pregnant. Stated that, the caller's daughter has not yet gotten her first covid vaccine shot. The outcome of the events for swelling larger an egg under armpit and fluid retention at his chest and back for 2 days was recovering while for the other events was not recovered.  Information on the lot/batch number has been requested. Follow-up attempts are completed. No further information is expected.
Information has been received from a physician assistant concerning a 72 year old female with allergy to sulfa, XYLOCAINE, morphine and erythromycin and no pertinent medical history who on 02-NOV-2000 was vaccinated with ZOSTAVAX (Merck) (Lot# 664627/0876Y, SC). Concomitant therapy included NEXIUM, ALLEGRA, LEVOXYL, calcium (unspecified), vitamin D (unspecified), aspirin and finasteride (manufacturer unknown). On 13-AUG-2010 the patient developed zoster. The patient had a raised red blister rash on her back. The patient had been seen by the physician. The physician prescribed VALTREX and NEURONTIN. There was no lab or diagnostic test performed. At the time of the report, the patient had not recovered from the events. Follow-up information received from a physician assistant concerning a 72 year old female with no illness at time of vaccination, who on 02-NOV-2000 at 9:00 am was vaccinated with a single dose of ZOSTAVAX (Merck) (lot# 664627/0876Y) SC in the left deltoid. On 16-AUG-2010 the patient developed shingles in the left thoracic trunk distribution (T5-6 dermatomal distribution). The patient had maximum temperature 98F, pain (4 degree), and no other systemic symptoms. No rash occurred at the site of injection or else where within 42 days of the vaccination. The patient had a history of chickenpox and there was no recent exposure to chickenpox or herpes zoster. There were no direct fluorescent antibody done and no specimen collected for PCR. No photo was taken. The patient required medical/surgical intervention. At the time of the reporting, the patient's status was unknown. Additional information has been requested.
2am, 36 hours after shot. Nausea, then vomiting and heavy sweating. Lasted for 1.5 hours, light nausea persists.
left arm swelling by 2pm day of vaccine, red from upper arm to elbow, swollen and painful 8/3/10 arm was still painful but not red
pt mom yelled for help. other employee dialed 911. mom reporting that patient keeps fainting/feeling nausea. used smelling salt x 2. then had patient have small sips of orange juice. patient began feeling nausea again and threw up. pt started breathing heavy/flushed/wheezing administered epi-pen (1st dose incomplete- bent needle) 2nd dose successful in muscle of right thigh. patient reported feeling better. took bp 94/54 pulse 88. ems arrived and took over. patient left with ems
Pain near left shoulder; pain is localized and increases when lifting arm over head; injection given near top of left shoulder. Pain continues.
Sore arm,  loss of pigment at injection site,  Polymyalgia rheumatica
Flu shot was given at 6:00PM. He went into anaphylactic shock at 9:00PM. Ambulance had to be called at 11:00PM. Patient went to the hospital where he had a full recovery.
h/a, dizziness, local lymphadenopathy & local reaction w/1st 2 dose of vax felt spacy & was also constipated; no complaints in the other doses;
Chronic stomach pain onset after 5 weeks, Diagnosis of Gastritis after 7 weeks. Increased agitation,irritability, nervousness, distractability. Diagnosis of Bipolar Disorder, General Anxiety Disorder, Oppositional Defiance Disorder after 4 months. Patient has had 3 endoscopies, 2 ultrasounds and an abdominal CT scan. Patient continues (after 11 months) to complain of chronic abdominla pain. Patient has been treated with various acid blocking medicines. Patient has been Baker Acted to a locked facility 5 times and once voluntarily in the past 5 months due to psychotic, self- injurious, violent behavior. Patient was admitted to a Behavioral Residnetial treatment center for 8 weeks. Patient has been on various anti-depressants, anti-psychotic and mood stabilizers. Patient is at present still under psychiatric, psychological and gastrointestinal care. Prior to vaccinations, 12 year old patient showed no evidence of either gastrointestinal condition or mental illness.  11/4/08 Reviewed PCP medical records of 1/4-9/16/08. FINAL DX: none provided Records reveal patient experienced general good health on 1/4/08.  RTC 2/6/08 w/cough, congestion, hoarseness & sore throat.  Dx w/pharyngitis.  RTC 2/15 w/abdominal pain, cough, constipation.  RTC 2/22, had missed 2 wks of school w/persistent abdominal pain, 6 # weight loss.  Admitted to hosp for peds GI consult.  Dx w/gastritis & GERD. Tx w/meds.  RTC 9/16/08 s/p admit for depression & bipolar disorder.
In the evening after the vaccination she stated her arm swelled and throbbed and was red. 11/17 She phoned the pharmacy and said the swelling had gone down but it the area was still red and swollen .  I recommended she see her Dr.  He thinks it is an injection site reaction and drew a circle around the redness and told patient to contact him if it gets worse or does not get better in 3 days.  The Dr. recommended she ice and elevate and take Naproxen
pt recv vax 29JUL97 & approx 1wk later pt devel vesicular lesions on lower extremities;mom subsequently devel varicella pharyngitis & grandmother devel shingles;
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 81 year-old female patient received bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE), intramuscular, administered in arm left, administration date 27Jan2021 11:00 (Lot number: EL9261) at the age of 81 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Heart stents" (ongoing); "Diabetes type 2" (ongoing); "Acid reflux (esophageal)" (ongoing); "Blood pressure" (unspecified if ongoing); "Supplementation therapy" (ongoing); "Heart medication" (ongoing); "Thyroid" (ongoing); "Blood thinner" (unspecified if ongoing); "sensitive skin" (unspecified if ongoing), notes: not been responsive to over the counter moisturizer creams; "Diet controlled" (unspecified if ongoing). Concomitant medication(s) included: DEXILANT taken for gastrooesophageal reflux disease (ongoing); RANEXA taken for cardiac disorder (ongoing); BENICAR taken for cardiac disorder (ongoing); SYNTHROID taken for thyroid disorder (ongoing); PLAVIX taken for blood disorder; TOPROL XL taken for blood pressure abnormal; BAYER ASPIRIN taken for cardiac disorder (ongoing); COQ-10 taken for cardiac disorder (ongoing); VITAMIN D3 taken for supplementation therapy (ongoing). The following information was reported: FATIGUE (non-serious) with onset Jan2021, outcome "unknown", described as "Just a little tired from it". Additional Information: The events did not result to emergency room or physician's office visit. The patient did not receive prior vaccinations (within 4 weeks). The patient took thyroid medications, and blood thinners and blood pressure medications. She said that took something to up her thyroid, but also took something to down it. She did not know which one it is. The patient did not undergo relevant tests. The patient also took the second dose of bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE) administered in right arm on 17Feb2021 at 10:30 and experienced she lost her sense of taste and it lasted about 1 days, stated that she tried something spicy and it just tasted like cardboard, she got a rash on her legs between her knees and her ankles on both legs, it was a itchy and bumpy rash and stated that it is subsiding but it was still there. No follow-up attempts are possible. No further information is expected.
Narrative: COVID infection following COVID vaccine series 04/30, Pfizer, dose #1 05/17, Pfizer, dose #2 09/15 pt cc: exposure: unknown 09/23 SARS-COV-2 Variant Sequencing result: pending 09/23 COVID swab, result: detected 10/1 COVID swab, result: detected 10/4 COVID swab, result: detected 10/4 SARS-COV-2 IgG: 0.35 10/4 CXR impression: the chest radiograph demonstrates subtle increased pulmonary parenchymal markings in the lung bases, especially on the right side. The pathology is similar to appearance seen on the chest x-ray of July 7, 2021, but worse than seen on the chest x-ray of May 19, 2021. The pattern suggests pulmonary parenchymal infiltrate/pneumonia. 10/5 Clinically resolved 10/24 COVID swab, result: NOT detected
patient did not disclose to vaccinator that he had received Jannsen COVID-19 vaccine on 3/22/21.  Patient answered "NO" to the questions "Have you ever received a dose of COVID-19 vaccine?" and "Have you received a vaccine in the last 14 days?"  on the consent form.
Local redness, firmness, swelling and tender reactive lymph node on (R) arm. Fever of 100.5 at home. BENADRYL, NSAIDS, ice. RN follow up 1/15 by phone. Reassure most reactions resolve 72 hrs. Will report for vaccine manufacturer.
I was admitted to the ER on Monday, March 22, at  10:30 p.m.  after receiving my 2nd dose at 9:00am.   I was then admitted to the ICU on Sunday, April 4, at 7:00pm  for continuing symptoms.
A spontaneous report was received from a nurse concerning a 59-year old, female patient who received Moderna's COVID-19 vaccine and experienced a round, indurated, red, and warm to touch injection site/injection site induration, injection site erythema, injection site warmth, sore arm/injection site pain, fatigue and body aches/pain.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 30 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (lot# 011J20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.   On an unknown date, the patient reported having a sore arm for a few days. On 07 Jan 2021, the patient woke up to a round, indurated, red, warm-to-touch reaction at the injection site. She also experienced fatigue and body aches.   Treatment of the events included paracetamol.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, a round, indurated, red, and warm to touch injection site, fatigue and body aches, was unknown.  The event, sore arm, was considered recovered/resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Information has been received from a Certified Medical Assistant referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, drugs reactions or allergies and concomitant therapies were not provided. On 25-APR-2017, the patient was inadvertently vaccinated with an expired dose of M-M-R II lot # M032153 and expiration date 22-APR-2017 (route of administration, dose and anatomical location were not provided) for prophylaxis in combination with sterile diluent. No adverse effects were reported.         Additional information has been requested.
This 74 year old female received the Covid shot on  3/12/21    and went to the ED on 4/11/21  with the  diagnoses listed below and died on 5/3/21. ABDOMINAL PAIN VOMITING
slowly progressive facial edema & dizziness;treated w/oral pred x 5 days;
Toilet bowl full of blood in pee. Shot was given on Saturday April 10 blood on toilet on April 12. Same thing happened after first shot on March 13. March 16 toilet bowl full of blood.
Right arm became severely swollen, red, warm to touch, difficulty lifting the arm, and developed a raised rash at site of injection.
reported that doses of GARDASIL9 had been administered following a temperature excursion; This spontaneous report has been received from a health professional, referring to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, concomitant medications, previous drug and/or allergy reactions were not reported.   On 19-AUG-2021, the patient was vaccinated with an improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) at a dose of 0.5 milliliter (vaccination scheme, route and anatomical location of administration were not provided; lot # T026167 has been verified to be a valid lot number, and expiration date reported and established upon internal review as 04-DEC-2022) as prophylaxis.   The administered vaccine underwent a temperature excursion below 2 degrees Celsius (°C) of -40.0 °C for a time frame of 15 minutes; and an excursion above 8°C of 9.6 °C for a time frame of 1 hour. No previous temperature excursion was reported. No information about the use of a datalogger was reported.   This is one of several cases, from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T026167; expirationdate: 04-DEC-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Seizure-one month after vaccine, Mom states could have been sooner, 1st visit  for seizure was 03/26/2001, Vaccines were given 6 days-early.
patient felt light headed and nauseous and then threw up a small amount on the ground. this occurred 10 minutes following vaccine administration
About 2-3 days I developed a frontal trunk rash. I went to dermatologist who treated it originally as fungal. Then, it went to arms and legs. I was then diagnosed with pityriasis rosea, which is triggered by a viral infection which I did not have any symptoms of. I also did an at home test for COVID-19, negative. Outcome of biopsy is still pending. Currently being treated with prescription steroid cream.
Pain, Swelling, High fever (104.3) degree, Headache, Body aches, sore joint and Nausea.
This spontaneous report as received from a licensed vocational nurse (also the mother of the patients) via a company representative refers to two female patients of unknown age. The patients' concurrent conditions and medical history were not reported. On an unknown date in 2013 (reported as "unspecified date 2 years ago") the two patients were vaccinated with their first doses of GARDASIL (1 single shot, dose, route and lot number not reported). On an unknown date in 2013 (reported as "unspecified date 2 years ago") after receiving the vaccines, the patients fainted in the office. The patients sought unspecified medical attention. Therapy with GARDASIL was discontinued and was not reintroduced. The outcome of the events was reported as recovered on an unspecified date. The causality between the events and GARDASIL was not reported. Additional information has been requested.
Client was injected with 0.3mL of Pfizer COVID-19 vaccine (lot ER8732) into left deltoid at 1356. She waited in the post-vaccine area for 30 minutes without symptoms. At 1430, client was in her car in the parking lot and began to feel "woozy" and noticed some redness and hives on her face and chest. Client re-entered the vaccination site where she was evaluated by myself. She had mild diffuse redness to her chin and upper chest. She reported feeling slightly woozy. EMS was called at 1436. At 1443, client reported that she was starting to feel like she was "having an out of body experience" and that if felt like someone "had two fingers and was pushing on [her] chest." EMS arrived and transported client to ED. No treatment was provided at the vaccination site.
The pt came in 11/10/16 and said that his arm became so sore after receiving Pneumovax 23 and Fluzone HD in his left arm 11/09/16 that he needed to go by ambulance around 5am this morning to Hospital.  The pt said he received the immunizations at 11am and by 6pm his arm became very painful. The pt said that he had used acetaminophen and iced his arm, but it did not touch the pain. The pt said that he could not lift his arm.  The pt said that the physicians there did not think it was a reaction to the immunizations, but the pt feels that it is related.  Dr. prescribed tramadol. The pt picked up the tramadol and described the event as stated above.
Fever, nausea, swollen lymph nodes, headache, tiredness, muscle and joint pain
Patient noted bruising at injection site the following morning. Patient felt sore at injection site that evening. Patient also noted area from injection site to half way down left arm to be blackened. Patient stated that blackened coloring changed to red colored 3-4 days after injection. Patient states she felt chills x 6 days. Patient denied fever. Patient stated that both cheeks became reddened. Patient states that she has a history of having reddened cheeks as part of an allergic reaction to allergens.
After vaccinating for flu on the right deltoid, patient appeared to stiffen, deflate, and then start shaking.  I held onto her body so that she wouldn't topple over from the chair.   After a few seconds, the shaking stopped, and the patient opened her eyes.    I asked her if she was OK and if this has happened before & she said after a flu vaccination as a freshman in high school.    She appeared stable, so I told employee to call management.   Pt.'s parents introduced themself when management arrived, and they recounted the flu shot episode and that this occurred as well after giving blood earlier this year.   Patient had been examined (via blood work & CT scan) and was just diagnosed with anxiety.    I told them she should be seen by provider ASAP; they refused a call for ambulance.   After sitting in vaccination room for about 5-6 minutes, I asked pt. to sit with her parents in the waiting room for 10 minutes.
Narrative: COVID infection following COVID vaccine series 01/15, Pfizer, dose #1 02/06, Pfizer, dose #2 08/02 pt cc: chest congestion, cough, fatigue, loss of taste or smell, rhinorrhea exposure: wife 08/3-08/12 PT symptoms continue 08/09 COVID swab, result: detected 08/09 SARS-COV-2 Variant Sequencing results: pending 08/13 clinically resolved
Golf ball size lymph node enlargement in right neck, right axilla, and right groin areas with severe body aches, lower back pain, chills, fever, nausea. These enlarged lymph nodes were only noted upon physical exam after 2nd dose of vaccine.  However, employee did have a mammogram on 2/3/2021 which noted abnormalities in the right axilla area which was the day prior to 2nd dose of vaccine.  The severity of the enlargement of lymph nodes became more apparent after the 2nd dose within 12 hours of injection. Thus, causing concern by the Radiologist with the changes noted in the axilla lymph nodes on mammogram imaging and future need for ultrasound surveillance.
Heart normal in December 2021. Received 2nd Moderna vaccine in January 2022. Diagnosed with Congestive Heart Failure in June 2022. Heart Doctor at time said the CHF is probably due to the vaccine.
I had arm soreness for about a day after receiving the vaccine. I tested positive for COVID-19 on 12/28/2022. I had cough, fatigue, fever, headache, nasal congestion, sore throat and body aches. I contacted my provider and got a prescription for Paxlovid. I did not have any complications taking the medication. My fever broke within twenty-four hours. All my other symptoms did not go away for almost three weeks, and I tested positive that whole time.
Was vaccinated for H1N1 twice, within a few days of being previously vaccinated for H1N1 at a private provider.  She received the nasal H1N1 on 11/18/2009 and received the H1N1 injectable a few days prior at a private provider.
Pt came in to the pharmacy on 8/29 and stated his arm still hurt after his shot on 8/27. He said the shot was very painful and the pain continued to get worse over the next couple days. It hurt to lift his arm. When he was called on 8/30, he stated it was somewhat better, and that it still hurt in the muscle where the shot was given (was questioned about it hurting in his shoulder area but he said no, in the muscle where the shot was given). He was counseled to take anti-inflammatories and put ice on his shoulder and seek medical attention if it did not get better in a couple days.
The day of I started feeling extreme fatigue. The first two days my temp was 100.8. My fatigue took 6-7 days to subside. I did consult with my Dr. He was on the fence if it was the vaccine or I caught something else. I took Covid test and both came back negative. Mt Dr. advised me to do a 10 day quarantine.
Tingling and numbness of the left arm radiating to the left neck immediately after receiving the vaccine. Symptoms resolved.  BP 139/72, HR 82, O2 sat 100%
Pain deep in thigh for 4 -5 days, leg and foot swelling. Went away and I received second shot. Extremely sick. Deep pain in calf, swelling, redness? couldn?t walk.  Went to ER.
Patient was given an injection of Novavax instead of Pfizer vaccine. Patient described having chest pain and arm pain. When called later patient also added that they had a fever.
- Swelling 2 cm induration on left lateral leg. Warm to touch. Treatment: MOTRIN prn.
Patient came to pharmacy on 11/02/18 to report she had cellulitis and her doctor told her it was an infection that could have been cause by a puncture. She received a PNEUMOVAX 23 on Oct 31, 2018. She woke up at 2am on 11/1/18 with a sore arm. She went to see her doctor on 11/2/18 and was told that her cellulitis was most likely from her vaccination.
Arterial blood clot to the superior mesenteric artery resulting in ischemic necrosis of the small bowel.
No adverse event; The patient received monovalent Moderna Covid-19 vaccine instead of Moderna Bivalent Vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (The patient received monovalent Moderna Covid-19 vaccine instead of Moderna Bivalent Vaccine) and NO ADVERSE EVENT (No adverse event) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014B22A) for COVID-19 prophylaxis.     No Medical History information was reported.         For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (The patient received monovalent Moderna Covid-19 vaccine instead of Moderna Bivalent Vaccine).    Patient received monovalent Moderna COVID-19 vaccine instead of Moderna Bivalent vaccine. Bivalent vaccine Lot 057A22A expiration date February 6, 2023.  No concomitant medication reported. No treatment medication reported.
blisters on face, eye swollen shut, whelps, blisters, ear canal swelled almost shut;