chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Dizziness, fatigue, headaches, and low grade fevers for six days since vaccination but also starting 6-7 days prior to vaccination. Patient presented to outpatient clinic due to increase in symptom intensity in past 3-4 days. Patient was recommended to continue taking fluids including Pedialyte, utilize acetaminophen and avoid caffeine and alcohol by provider. The clinic will contact patient with results from their lab work that was ordered and drawn today (CBC and CMP) Patient was afebrile (98.3 degrees F) at visit today
Fever chills 9pm thru 130am, weak and tired next 2 days
Started experiencing shortness of breath, fever with severe/uncontrollable shaking in arms and legs, and confusion and dizziness around 6 hours after receiving the vaccine. Also experienced painful headache around 3 hours after receiving vaccine.
Janssen Covid-19 vaccine EUA caused me to feel extreme muscle pain, lower back pain specifically, I felt nauseous, had a severe headache, was light sensitive
Patient states that within about 24 hours of having the vaccine she developed and low fever and body aches. Then on about the second day her bottom lip was swollen. She said she didn't develop swelling or itching in the throat or body.
Severe pain, tenderness, swelling, of the entire upper arm. Numbness and cold sensation of arm, hand, fingers. 6" x 2" area of dark discoloration surrounding injection site. In 24 hours discolored area progressed to a large blister with sloughing of skin. Treated with prednisone. Symptoms resolved slowly over a week. Sequella of hypopigmentation and hyperesthesia of anterolateral upper arm.
Per patient, he had not received any COVID-19 vaccines yet and this would be his first dose. After the mobile clinic, when entering the patient's information, it was found the patient was not truthful in regards to his vaccination status. He had actually received his primary series, 1st booster, and 2nd booster with Pfizer through a different pharmacy. His second booster was 7/23/2021 per the Immunization Registry.
Pseudoexacerbation; This spontaneous case was reported by a non-health professional and describes the occurrence of MULTIPLE SCLEROSIS PSEUDO RELAPSE (Pseudoexacerbation) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Multiple sclerosis and Colon cancer. Concomitant products included OCRELIZUMAB (OCREVUS) for an unknown indication.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MULTIPLE SCLEROSIS PSEUDO RELAPSE (Pseudoexacerbation) (seriousness criterion medically significant). At the time of the report, MULTIPLE SCLEROSIS PSEUDO RELAPSE (Pseudoexacerbation) had resolved.            Treatment information was not provided.  Company comment included This is a spontaneous case concerning a 46-year-old male patient with concurrent medical conditions of Multiple sclerosis and Colon cancer, who experienced unexpected event of Multiple sclerosis pseudo relapse. It was reported that patient received third dose of mRNA-1273 . It is not possible to establish a temporal relationship as vaccination date and start date of the event were not provided. Clinical course and treatment details were not disclosed. Further information has been requested. Concurrent medical condition of colon cancer remains a confounder for the event Multiple sclerosis pseudo relapse. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 46-year-old male patient with concurrent medical conditions of Multiple sclerosis and Colon cancer, who experienced unexpected event of Multiple sclerosis pseudo relapse. It was reported that patient received third dose of mRNA-1273 . It is not possible to establish a temporal relationship as vaccination date and start date of the event were not provided. Clinical course and treatment details were not disclosed. Further information has been requested. Concurrent medical condition of colon cancer remains a confounder for the event Multiple sclerosis pseudo relapse. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
By end of first day arm area around shot had become red and sore.  By the next day my arm from my shoulder to my elbow was red, warm, very swollen and tender.   My are was so swollen that the sleeves of my shirt were tight.  Two days after the shot when the symptoms continued to worsen I scheduled an appointment at the clinic.   The healthcare provider prescribed a 15 day course of prednisone 20 mg tablets.   It took several days for the swelling in my arm to decrease.    This was the second Pneumococcal vaccine that  I have received.  On July 11, 2019 I was given the PCV13 vaccination.  I did not have any reaction to that vaccine.
Three days post vas, this pt developed cellulitis, a temperature of 99.3 F and swelling of the left upper arm and elbow.
Customer called to report a local reaction at the site of injection. stated she had a "knot" on her arm less than 1 inch in diameter. Advised to apply ice pack and take 50mg diphenhydramine every 6 hours as needed. Advised to monitor BP and if breathing problems or worsening of symptoms to seek medical attention. Checked with customer at 5:05 pm; pain subsiding. On follow up with patient, customer on Sunday 7-23-17, she stated that the swelling spread out on arm, "not real bad" tender but she felt it was impoving. Still using ice and diphenhydramine.
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-163-4298360-00 (RA). A 39 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date Feb2022 (Batch/Lot number: unknown) at the age of 39 years as dose 3 (booster), single, intramuscular, administration date 2021 (Batch/Lot number: unknown) as dose 2, single and intramuscular, administration date 2021 (Batch/Lot number: unknown) as dose 1, single for Covid-19 immunisation; Risankizumab (SKYRIZI [RISANKIZUMAB]), subcutaneous (ongoing) (Lot number: 1154543) at 150 mg (150 mg, (1 in 12 wk.)) for psoriasis. Relevant medical history included: "Covid" (unspecified if ongoing), notes: Other relevant history: 2nd time getting Covid. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 21Feb2022, outcome "recovering" and all described as "COVID-19". The action taken for Risankizumab was dosage not changed. Clinical course: It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Patient had No known allergies. The reporter's assessment of the causal relationship of the event with the suspect product 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 the available information in the case, the causal association between the events drug ineffective, suspected COVID-19 and the suspect drug BNT162B2 cannot be excluded.
Nausea, headache, low-grade fever, malaise, tenderness/itchyness at injection site. Took tylenol and left early from work
On 6/19/21, while in ED noted to be diaphoretic with crushing substernal chest pain. Noted to have ST elevations on anterolateral leads and trop elevation that peaked at  9.35. Patient taken to cath lab without evidence of coronary artery disease. ECHO with global hypokinesis with estimated EF 40-45%. Our top differentials at this time being myocarditis vs. spasm. He is going for cardiac mri 6/21.
Received H1N1 at school. Came to office with complaint of headache and not feeling good. Mother called and went home with mother.
Rash above arm where shot was given that spread to my right neck, then spread to my chest, then up my left neck side. Congestion. Rash is itchy. Have tried taking benadryl and rash will not go away even after 2 weeks.
body pain/ Soreness; Headache; Fever up to 101.7; Shivers; This is a spontaneous report from a contactable consumer (patient's husband). A 62-year-old female patient received first dose BNT162B2 of (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3246, expiration date: Apr2021), via an unspecified route of administration on left arm on 14Jan2021 10:00 at SINGLE DOSE for COVID-19 immunization (patient is a medical worker). There were no medical history and concomitant medication. The patient noticed about 21:00 on 14Jan2021, she was having body pain and a headache. The patient's husband took her upstairs and took her temperature and she had a fever and then she got the shivers which went on for quite a while. The hot bath seemed to help. She has had no other treatment. The patient's husband stated that his wife and he both got inoculated at the local hospital. He was fine but his wife has a fever up to 101.7 and he was asking if she take ibuprofen as she has a roaring headache and she was sore. The patient has been taking baths to relieve the soreness. No prior vaccinations (within 4 weeks). No additional vaccines administered on same date of the Pfizer vaccine. No event required a visit to physician or emergency room. There were currently no vaccines available for the second dose, but she is planning to get the second dose 31Jan2021. The outcome of the event Shivers was recovered on 14Jan2021 and the outcome of the other events were not recovered.
Erythema multiforme rash  developed within 2 weeks of the vaccine and progressed over the next 2 weeks.  Patient had fatigue, abdominal pain, nausea, and vomiting about a week after the first spots appeared. Prednisone x 3 days was initially prescribed with  no progression but no resolution of the rash. After patient came off steroids, rash progressed and was then restarted. After one dose, patient started vomiting repeatedly and was seen in the ED. Prednisone was discontinued and patient was started on topical steroids and hydroxyzine with improvement.
Multiple heart rhythm irregularities including  AFib breakthroughs and tachycardia starting on 5-18-2021 thru 7-15-2021 . Went to cardiac electrophysiologist and was put on a Zio irhythm monitor for 2 weeks which documented over 20 tachycardia episodes and AFib breakthroughs ranging from a few minutes to over 2 hours 15 min  while wearing the monitor. After monitor was turned in patient experienced multiple increased episodes resulting in hours long AFib episodes which were uncontrolled by prescribed medication increases and almost running to the emergency room on 2 occasions to get it under control. Outbreak Episodes stopped almost 2 months after last dose.
This spontaneous case reported by a consumer, describes the occurrence of asthenia (felt like passed out), pain (felt all the body like punctured by needles), pain in extremity (sore arm), peripheral swelling (fingers & tiptoes looked like cherries) and dizziness (weird/dazed) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 040A21A) for COVID-19 vaccination. The occurrence of additional events detailed below. No medical history reported. On Mar 23, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19  vaccine), unknown route; 1 dosage form. On Mar 30, 2021, patient experienced asthenia (felt like passed out), pain (felt all the body like punctured by needles), pain in extremity (sore arm), peripheral swelling (fingers & tiptoes looked like cherries), dizziness (weird/dazed) and headache. The patient was treated with Tylenol (paracetamol), at an unspecified dose and frequency. At the time of the report, asthenia (felt like passed out), pain (felt all the body like punctured by needles), pain in extremity (sore arm), dizziness (weird/dazed) and headache outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant medications reported.
His right arm swelling, blistering, tenderness, spreading, hard in the middle and he is in pain. I took him to hospital they gave him Cephalexin, Ibuprofen and M-PaP medication.
Have been having bleeding and bruising episodes ever since.  Fell on 4/5 and began bleeding in 4/8;and knee MRI shows bleeding that still has not appeared to have resolved and has been noted as typical for a hemophiliac which I am not   Have had several subsequent episodes of unexplained bruising.    Went to factor to have my platelets tested and baked for  days after the test to the extent of bleeding through 3 layers of bedding during the night.  When I had my blood test done lab tech had a difficult time stopping my bleeding.  As I was leaving, I had to return as the bandaid came off and blood was spraying upward and my arm needed to be wrapped.  Platelets test came out normal but I am still bleeding and bruising but it is getting less frequent as time from vaccine goes on but still having problems with joint bleed in my knee ( seeing an ortho for that);
Narrative: COVID infection following COVID vaccine series 03/02, Moderna, dose #1 03/29 Moderna , dose #2 08/18 pt cc: diarrhea, fatigue, fever, headache, rhinorrhea exposure: unknown 08/20 COVID swab, result: detected
1st dose (2/15/21): gave very sore arm that she could not lift or pick anything up with. 2nd dose: (3/16/21) she had a swollen, hot arm and extreme pain in both arms, itchy rash that spread across both arms, chest, and under the breast, popping sensations in jaw and other bones and joints. During a routine physical after the vaccine, blood work was done and arthritis markers were found ( no previous history).
This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue on the day of 2nd dose) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007C21A, 036A21A and 034F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Apr-2021, the patient experienced FATIGUE (Fatigue on the day of 2nd dose). At the time of the report, FATIGUE (Fatigue on the day of 2nd dose) outcome was unknown.            This case was linked to MOD-2022-445612, MOD-2022-445628, MOD-2022-445612 (Patient Link).
Mother called this nurse today and stated that about 1 hour after the patient got the vaccine she started having chills, headache, and nausea. This morning she woke up with a very swollen arm and now mother states that the patient can hardly move her arm. Advised to get seen as soon as possible.
CHRONIC HYPOXEMIC RESPIRATORY FAILURE 1/29/2023 --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Information has been received from a registered nurse concerning a 15 year old patient of unknown gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported. On 07-JAN-2016, this patient was vaccinated with a dose of PROQUAD (strength, dose, route, lot # and expiration date not reported). No adverse symptoms were reported. Additional information has been requested.
Information has been received from a registered nurse concerning a patient with no relevant medical history who in 2001 at 12 months of age was vaccinated with a dose of varicella virus vaccine live. It was noted that the patient had "recently" developed a breakthrough rash. Unspecified medical attention was sought. It was unknown if the patient had recovered. There was no product quality complaint involved. At the time of this report the child was 36 months of age. Additional information has been requested.
tested positive for the COVID-19 virus; tested positive for the COVID-19 virus; This is a spontaneous report from a contactable nurse. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported.  The patient was tested positive for the COVID-19 virus on an unspecified date after being administered with the vaccine. The outcome of the event was unknown.   Information on Lot/Batch number has been requested.; Sender's Comments: Based on the information currently available, a lack of efficacy with the suspected vaccine BNT162B2 in this patient cannot be completely excluded. Further information like confirmative virus genome /nucleic acid detection is needed for meaningful medical assessment. ,Linked Report(s) : US-PFIZER INC-2021005630 same reporter and drug, different patient and event
High fever (104 degrees) for several days. Loss of appetite. Body aches. Fatigue.
upper chest tightness, throat discomfort, skin flushing started within 15 minutes after vaccine. Resolved after 15 minutes of monitoring
3/29-Date and time of vaccination: (list both if they received both shots): Pfizer 1/12/2021, Moderna 3/21/2021 Brand and lot of vaccine: Moderna lot #048A21A, Pfizer at private nursing home, unknown lot number Fever, generalized weakness, chills, weakness. Received tylenol which helped with symptoms. Symptoms mostly resolved except for continued weakness. 3/30-is doing much better, symptoms resolved
Initial and follow up information has been received from a 59 year old white female registered nurse and an other health professional respectively. On 01-MAY-2007 the 59 year old registered nurse was vaccinated SC in the right deltoid with a single first dose of Zostavax (lot # 656606/0033U). There was no illness at the time of vaccination. On 02-MAY-2007 the patient developed flu-like symptoms with no temp. Unspecified medical attention was sought however an ER/doctor visit was not required. On 07-MAY-2007 the patient recovered. No further information was provided. There was no product quality complaint involved. Additional information is not expected.
RED, SWOLLEN, WARM TO TOUCH, VERY SORE, HEAVY FEELING.
Sensitivity in teeth; Sensitivity in jaw; Intermittent ear pain; Numbness in chin; Nausea; Difficulty eating, can't drink anything hot or cold; Feeling cold; Tired; This case was reported by a other health professional via call center representative and described the occurrence of sensitivity of teeth in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th September 2022, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, several days after receiving Shingrix, the patient experienced sensitivity of teeth, jaw pain, ear pain, numbness facial, nausea, eating disorder, feeling cold and tiredness. On an unknown date, the outcome of the sensitivity of teeth, jaw pain, ear pain, numbness facial, nausea, eating disorder, feeling cold and tiredness were not recovered/not resolved.   It was unknown if the reporter considered the sensitivity of teeth, jaw pain, ear pain, numbness facial, nausea, eating disorder, feeling cold and tiredness to be related to Shingrix.   Additional Information: GSK Receipt Date: 17-OCT-2022 Reporter's Comments: The patient reports she received dose of Shingrix in the right arm.  The patient stated few days later had sensitivity in lower right jaw and teeth. The patient stated she also had ear pain, intermittently.  The patient also mentioned numbness in chin, nausea with difficulty eating, had cold and was tired. The patient mentioned she had seen her HCP and dentist and neither could find a diagnosis.  The patient asked about receiving 2nd dose. Information provided.  All symptoms still persisted, not recovered or resolved. The reporter spoke per (package insert) PI and FAQ content.  The patient also states she was an HCP. The phone number and transfer provided.  Medical disclaimer and referred to HCP.  The reporter did not consent to follow up.
After my 2nd one about 6 weeks later my lymph node on my collarbone was swollen and moving around. I did a cat scan and they found nothing. Today I experienced it again with excruciating pain on my collar bone, moving lymph node and left neck pain after having my booster yesterday. I started to feel the pain around 4pm and when I felt my collarbone is when I noticed the moving lymph node
Pain and Swelling of derma filler under right eye about 30 hours after dose. Fillers were placed in July (6months ago).
Woke up early in the am on 2/13/21 with extreme chills, muscle aches, and joint pain. Did not check temperature at that time but took 800 mg of Advil due to the severity of the symptoms and went back to sleep. Woke up from nightmares x 2 throughout the night that I was being physically hurt. When I woke up I was crying and realized both times I was still having muscle and joint pain. Finally got up around 1100 in pain still. Calves, thighs, deltoids, triceps bilaterally had severe aching and soreness. Joints hurt generalized. Even my fingers on both hands hurt. I took 800 mg of Advil and 2 Tylenol 500 mg. After about an hour and a half went by and I finally felt my pain ease up, I did check my temp. It was 100.9 after the med dosing. I kept having to continue to take these meds throughout the day and slept the whole day. I did not get up until about 5 pm. Then went back to sleep at around 1100 pm. The next day, on 2/14/21, I seemed better but toward the end of the day I got a sore throat. The following day, on 2/15/21, I was very fatigued throughout the day. I did not feel better until 2/16/21.
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient. A 70-year-old female patient received BNT162b2 (BNT162B2), on 01Jan2021 as dose 1, single (Lot number: EL8982), in left arm, on 11Feb2021 as dose 2, single (Lot number: EL9262), in left arm, on 24Sep2021 as dose 3 (booster), single (Lot number: FF2588), in left arm and on 06Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 70 years, in left arm for Covid-19 immunisation; rosuvastatin calcium (ROSUVASTATIN CALCIUM), (Batch/Lot number: unknown) at 5 mg 1x/day (5 mg, 1x/day (once a day, in the evening)) for blood cholesterol abnormal. The patient's relevant medical history included: "underactive thyroid" (unspecified if ongoing); "Osteopenia" (unspecified if ongoing); "Blood thinners" (unspecified if ongoing), notes: Her partner was with her but he can't take Blood thinners on this medication; "arthritis" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE [LEVOTHYROXINE SODIUM] taken for thyroid disorder; CALCIUM. Past drug history included: Synthroid, notes: this runs in her family and she has been taking the Synthroid for 20 years, probably. The following information was reported: VACCINATION FAILURE (medically significant), SARS-COV-2 TEST POSITIVE (medically significant), outcome "unknown" and all described as "tested positive for Covid, after being fully vaccinated". Suspect Products: Covid vaccine: Clarified that the caller had all four doses in the left arm. Indication: She was trying to be diligent and not get Covid. Description of complaint was tested positive for Covid, after being fully vaccinated. The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; Weight: lost a few pounds, notes: She is 137 now and has lost a few pounds. The action taken for rosuvastatin calcium was temporarily withdrawn. Therapeutic measures were taken as a result of sars-cov-2 test positive. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.