chrisvoncsefalvay/vaers-outcomes huggingface dataset:
left armpit swelling of gland.; This is a spontaneous report from a non-contactable consumer, the patient. A 43-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206) via an unspecified route of administration in the arm left on an unknown date at 14:45 (at the age of 43-year-old) and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration on an unknown date in 2021 as a single dose for COVID-19 immunization. Medical history was not reported. The patient received unspecified medication within two weeks of vaccination. Patient was allergic to ibuprofen (MANUFACTURER UNKNOWN) from an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 08Mar2021 the patient experienced left armpit swelling of gland. Event happened about 5 days after the first dose and the next morning after the 2nd dose. The first one went away after about 3 days. The patient did not receive any treatment for the event. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event left armpit swelling of gland was recovered.   No follow-up attempts are needed. No further information is expected.
Pt presents with swelling redness and warmth to L deltoid area. Ice packs were applied, and was prescribed KEFLEX for cellulitis.
Information has been received from a registered pharmacist concerning a 67-year-old male with an allergy to codeine, hypertension, hypothyroidism and atrial fibrillation who on 01-OCT-2007 was vaccinated subcutaneous with a 0.65 ml dose of Zostavax (Oka/Merck).  Concomitant vaccines administered on 01-OCT-2007 included Pneumovax 23 (MSD) and influenza virus vaccine (unspecified).  On approximately 01-OCT-2007 (after vaccination) the patient developed a fever of 102 degrees and a rash at the injection site.  The patient sought medical attention via a phone call with their physician.  No diagnostic labs were performed.  At the time of the report the patient's status was not recovered.  A product quality complaint was not involved.  Follow-up information received on 22-OCT-2007: The reporter felt the "adverse reaction was to the flu vaccine and not Zostavax (Oka/Merck)".  Additional information is not expected.
Initial report received from a consumer's attorney on 21 Dec 2010: This patient was vaccinated with seasonal influenza virus vaccine (manufacturer unknown, batch number unknown) on an unspecified date. The patient stated that her throat was swelling up and she had difficulty breathing. She was administered epinephrine injection and taken to hospital. The outcome of the event was not reported.
Patient was given an undiluted form of the COVID Pfizer Pediatric vaccine. Parents and PCP were contacted, and no adverse effects reported at this moment
3 hrs after receiving vaccine, pt developed itching on her body, her tongue swelled up, had trouble breathing/swallowing and started coughing. She took BENADRY immediately. At bed time had fever/chills. Next day felt much better, tongue still felt "a little strange, hard."
Body aches, headache, severe chills, fever up to 101, light headed/dizzy all started about 12 hours after injection.  The most significant side effects subsided within 12 - 15 hours after onset (about 24 - 27 hours after the inection.   dull headache and light headed feeling went away about 36 hours after injection.  No medical treatment was sought.  I took two Advil on Friday morning (injection was 11:15 am Thursday), but did not take more because I read an article that suggested taking Advil and similar medications could negatively affect the anti body production.
Patient reported chills, fever, stomach pain, nausea, and pain in legs. These symptoms started the day after the vaccine and lasted about 24 hours before they resolved.
She has been able to eat, but nothing taste that great; had a day and a half of diarrhea; She is having chills occasionally; She feels totally exhausted; she has felt so stupid; she doesn't feel well enough; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL8982), via an unspecified route of administration at left arm on 27Jan2021 13:50 at single dose for COVID-19 immunization. The patient received the vaccine due to her age and she was due for it. Medical history included fractured ankle. Pateint's height was five two and shrinking. She is on (networking site) with people she went to high school with and they are all getting the shot at same time because of their age. They were all saying they have had no side effects and no symptoms. There were no concomitant medications. The patient read the information they gave her after the shot. Now, she knows why she has felt so stupid. It was all the stuff on the list. On 28Jan2021 about 19:00, she had a day and a half of diarrhea and she was having chills occasionally. On 28Jan2021, she felt totally exhausted. A little bit of everything. She was not nauseous. On 29Jan2021, she has been able to eat, but nothing tasted that great. Even when her son got her what she wanted it still did not taste great. She is coming off a fractured ankle and she is going to have cancel therapy because she doesn't feel well enough to do that. She got the first vaccine on 27Jan2021. It will be a week on Wednesday. On Thursday and Friday she had diarrhea. Serious quantity of Pepto Bismol kept that at bay. The exhaustion has only improved a little. It was good for her to get up and move.  No additional vaccines administered on same date of the Pfizer suspect. The adverse events did not require a visit to Emergency Room or Physician Office. No prior vaccinations (within 4 weeks). The outcome of the event diarrhea was recovered on 29Jan2021; events chills and exhausted was recovering; event 'she has been able to eat, but nothing taste that great' was not recovered; and unknown outcome for the other events.
The patient got the Moderna vaccine on 3/2/2021. On 3/3/2021 he suffered a dissection of the ascending thoracic aorta and died.
ovarian cyst/ Haemorrhagic Cyst; Irregular menstruation; Abnormal menstruation; Abdominal cramps and bloating; Abdominal cramps and bloating; This is a spontaneous report received from a contactable Physician. This is the second report of two reports. This report is related to the second vaccination dose. A 30-year-old patient of unknown gender received the second dose of bnt162b2 on 21May2021 at 16:00 (lot number: EW0170) Intramuscularly in left arm at single dose for COVID-19 immunization. Medical history included Acute appendicitis in 2011, Laparoscopic appendectomy in 2011. Concomitant medications were reported as none. Historical vaccine included the first dose of bnt162b2 on 30Apr2021 at 04:00 PM (Lot no: ER8731) (at the age of 30-years-old) Intramuscularly in right arm for COVID-19 immunization, experienced Abdominal cramps and bloating. Prior vaccination was reported as None. Family medical history was reported as None. Patient experienced Irregular menstruation (medically significant) on 02Jun2021 at 09:00 am, Abnormal menstruation on 02Jun2021, ovarian cyst/ Haemorrhagic Cyst (medically significant) on 30Jun2021, Abdominal cramps and bloating in 2021. The events were required physician office visit. Patient received treatment for events Irregular menstruation, ovarian cyst/ Haemorrhagic Cyst, Abnormal menstruation. Second vaccine dose administered on 21May2021. Abdominal cramps and bloating persisted. Abnormal menstruation on 02Jun2021. Patient was evaluated by OB/Gyn, FNP and Pelvic and transvaginal Ultrasound ordered 30Jun2021. Patient had ultrasounds at 3:21pm on 30Jun2021. Haemorrhagic Cyst noted on transvaginal ultrasound No history of ovarian cyst in patient prior. Lab data included: Antibody test to platelet factor IV on unknown date: Unknown results; Transvaginal ultrasound on 30Jun2021: Right away cyst, Haemorrhagic Cyst; Pelvic Ultrasound on 30Jun2021: Normal. The outcome of the events was not recovered. Physician considered the Pfizer product had a causal effect to the adverse events.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Menstruation irregular, Haemorrhagic ovarian cyst and  Menstruation abnormal cannot be totally excluded.The impact of this report the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Initial unsolicited report received from physician via other company (Pfizer) (manufacturer report number - 2016305378) on 23 June 2016. This case involves a female patient (age was not reported) who was vaccinated with a dose of Tetanus Vaccine (Batch number, expiration date, dose, route and site of administration was not reported) on an unspecified date. Patient's ongoing illness, medical history and concomitant medications were not reported. On an unspecified date, post vaccination, patient developed allergic to tetanus vaccine. Laboratory investigations and corrective treatment were not reported. The outcome of the event was not reported. List of documents held by sender: none.
pt recv vax AUG97 & in late AUG97 pt exp alopecia, fever, swollen arm & arthritis;
Patient was given TDAP, HEP A, VZV, MCV4 and HPV4 vaccines. Approximately 30 seconds after receiving last vaccine (HPV4), he experienced syncope with 5-10 seconds of seizure activity consisting of generalized twitching. He regained full consciousness in approximately one minute. BP was 114/63. Rested 20 min. and felt fine. Advised parent to F/U with MD.
Arm red and swollen. That night arm got more swollen. There is fluid under his arm. ED doctor said shot was in the wrong place-way too low.
Coughing, tight chest, (Lf arm sore, swollen) lethargic, swollen throat, trouble swallowing, weak, bloodshot eyes, temp 99.4-99.5, stuffy nose, achy joints, headache, dizzy.
Patient presented to the pharmacy with a 3inch by 4inch red, slightly raised, warm patch at the injection site. She stated that she didn't think that it had gotten any bigger. She received the immunization 8/17/17 in the afternoon and did not notice the reaction until after 6pm on 8/18/17. Patient stated that she would take TYLENOL for the reaction but did not feel that it was an allergic reaction and did not seek medical treatment.
Extreme body ache, fatigue, headache, no appetite, and some shortness of breath.
Had large area of redness, warmth, and swelling around injection site. Started 1 day after immunization was admin. BENADRYL as directed. R Arm.
Information has been received from a medical assistant concerning an 18 year old female with no pertinent medical history who on 16-APR-2007 was vaccinated with 0.5 ml of the first dose of the Gardasil. On 21-JUN-2007 at 8:45 am, the patient was vaccinated intramuscularly with 0.5 ml of the second dose of Gardasil (Lot # 658100/0525U). There was no concomitant medication. A laboratory pregnancy test was performed and the result was negative. On 21-JUN-2007, at noon, the patient experienced shortness of breath, intermittent tingling of the lips and the feeling of her arm being heavy and difficult to lift. The motion of the patient's arm had gotten worse since 21-JUN-2007 and she found it difficult to do her hair because of the arm. Patient was scheduled to be evaluated at her physician's office on 26-JUN-2007. At the time of the report, the patient's shortness of breath, intermittent tingling of the lips, and feeling of her arm being heavy and difficult to lift persisted. The medical assistant considered the shortness of breath, intermittent tingling of the lips and feeling of her arm being heavy and difficult to lift to be a disabling event. Additional information has been requested.
patient entered pharmacy wanting to get shingle shot and he said he never got it.  So we tested the claim to see if it covered by his insurance and it was covered.  After giving shingle vaccine, I saw his profile that he has gotten 2 series shots in 6/21/2019 and 11/5/2019
Info has been received from a physician concerning an 8 year old white female twin student who on 9/29/97, was vaccinated with a dose of varicella virus vaccine live. The physician reported that on 2/8/05, the pt developed an itchy, papulovesicular rash at different stages all over her trunk and face. Medical attention was not sought and no laboratory/diagnostic tests were performed. Subsequently, the pt recovered from the itchy papulovesicular rash. No further info is available.
At initial onset mild fever and chest congestion. Next two days were filled with trouble breathing, clear runny nose and fever in the 103 range. Small red bumps started to appear on trunk. On 7/4/16 the fever was in the 104 range, bumps were all over trunk, forehead and thighs.
VACCINATED AT 1300. C/O RUE NUMBNESS AND DISCOMFORT IN RIGHT PALM AT 1310. PT HAD BEEN LEANING ON RIGHT ARM OF CHAIR WITH RUE HOLDING CELL PHONE IN RIGHT HAND AND USING RIGHT THUMB TO SCROLL. ASKED PT TO SIT UP AND NOT PLACE ARM ON ARM REST. AFTER 5 MINUTES SHE VERBALIZED "IT'S A LITTLE BETTER". AT 1330 VITAL SIGNS WERE TAKEN. B/P 127/73, HR 64 AND SPO2 98%. NO OTHER SIGNS OF ACUTE DISTRESS NOTED OTHER THAN THE NUMBNESS IN HER ARM. SHE WANTED TO BE ASSESSED BY PHYSICIAN "JUST IN CASE." ESCORTED BY RN TO THE EMERGENCY ROOM
11/6/02 client c/o upper and lower lip swelling, achey all over, c/o clearing throat more than usual c/o face swelling. Denies shortness of breath, no difficulty breathing. Client is slightly improving as time passes.
Information has been received from a nurse from a doctors office concerning a female of unknown age who was vaccinated with a dose of Pneumococcal 23v polysaccharide vaccine (date unknown). Subsequently, following vaccination the pt experienced swelling of her arm and face. Unspecified medical attention was sought. The nurse did not report any details but did say that the pt recovered. There was no product quality complaint involved. Additional information has been requested.
28 month old, Dx with tonic clonic and myoclonic seizures (new onset) on 11/29/09. Mother denies fever. He was transferred from ER to one hospital then to another. Started on VALPROIC ACID and discharged on 12/2/09. No further seizure activity noted. Received 2nd dose of H1N1 .25 ml on 12/11/09 and seizure activity resumed on 12/13/09. Client again was hospitalized. ER reports temp 101 degrees.
After the first shot of Pfizer, I started to have cold sore ( never have cold sore before). I started to take cold sore shield pills one a day and using abreva to treat cold sore. While I am still treating cold sore, I received 2 nd dose of Covid. After exact 1 week of 2nd shot, I had an allergy reaction. I was driving to work and had hive throughout of face, neck and torso. Unknown the cause, no new cream/regime for face, no new food, and no other new medications. Beside hives and itchiness, no other upper respiratory distress s/s. The hives went away after 30 minutes.
Per patient: approximately 1 hour after receiving the first shingrix vaccine, he states he got a nose bleed that lasted a couple hours before it stopped. He also said he got flu-like symptoms for a few days after as well. He said nothing out of the normal happened that day that should have caused it. No further incident after this.
Swelling, redness, itching, large bruise, pain at the injection site. Redness is shown on arm about 4 inches in length, 3 inches in width that has gotten progressively worse the past few days . I will be doing a virtual appointment with my primary care physician today to discuss further.
patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided.  It was reported that there were no power outages, but the facility was not able to download digital data logger. The data logger was unable to download the data for Dec-2021, Jan-2022 and Feb-2022 No treatment medication information was given.
I had the vaccine and after about 3 hours I went home I took a shower and I felt horrible with severe fatigue, I started running a fever, did not eat supper, was not feeling good and had diarrhea, by the end of the day I was throwing up, had chills, and a head ache, I had every symptom other than shortness of breath. It lasted for 4 days. I did not get out of the bed, only to go to the restroom and with assistance. I contacted the hospital and talk to the nurse that was in charge of the vaccination program . My arm was red about 9 cm size swollen, elevated. I could not brush my teeth, hair, wash my face or take a shower. I used baby wipes to wipe my behind. It was awful. I was totally useless, unable to work, unable to do anything.  I contacted my practitioner and told her what was going on.  I still have fatigue and muscle and joint pain that I did not have before. I took all of my migraine medications available and that did not touch it. I stayed in bed. I never had a headache like this before. My practitioner told me that many people that had the same vaccine had the same symptoms. My tempt went up to 102 and that is not normal for me. I did not go to the ER because I was not having difficulty breathing.
1st dose 2-3 years ago, forgot 2nd dose; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a 82-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (had 1st dose of Shingrix about 2-3 years ago).   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: 2-Aug-2022 Reporter's comment: The case was received from the patient via (Shingrix GSK Chatbot) interactive digital media. The patient had 1st dose of Shingrix about 2 to 3 years ago and forgot to follow up on 2nd dose.  The patient was concerned about getting 2nd dose now and wonder if better to start over and requesting for advise.  Additional supportive information: Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination. The follow-up could not be possible as no contact details were available.
About 36hrs after the vaccine I woke up to a very irregular heartbeat associated by light pressure and extreme irregularity.  Not much pain but pressure and gradually started to improve after about a week, but I could still bouts of the irregularity on various days
Child had 3 seizures on 9/8/07 after receiving shots.  Child had a history of seizure disorder.
Localized reaction to tetanus vaccination no systemic response 4 cm x 6 cm red indurated area, at site of vaccination.
Tested positive for COVID after first dose; Second dose administered almost 90 days after first dose; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Tested positive for COVID after first dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose administered almost 90 days after first dose) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose administered almost 90 days after first dose). On an unknown date, the patient experienced SARS-COV-2 TEST POSITIVE (Tested positive for COVID after first dose). At the time of the report, SARS-COV-2 TEST POSITIVE (Tested positive for COVID after first dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose administered almost 90 days after first dose) outcome was unknown. Not Provided          No Concomitant medications were provided No Treatment information provided    This case was linked to MOD-2021-099029 (Patient Link).
blood tests, T-cells are up high; she's having a hard time; This is a spontaneous report from a Pfizer- sponsored program from a contactable consumer (patient). An 85 years old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route of administration on 09Mar2021 at age of 85 years old at single dose for COVID-19 immunization. Medical history included she had pancreatic cancer 10 years ago and a breast cancer 5 years ago. Concomitant medications were not reported. Patient called to know if it was okay to undergo the following tests namely, CT scan with Dye and Nuclear bone scan as prescribed by her Oncologists due to readings on her blood tests, her T-cells are up high after getting her first dose of the Covid-19 vaccine today morning, 09Mar2021. According to patient she had pancreatic cancer 10 years ago and a breast cancer 5 years ago. Patient was very scared to undergo the Nuclear bone scan as it was something new to her and did not know how her body will react to such tests aside from the fact, she was having a hard time, making an appointment too. Outcome of events was unknown.   Information on the lot/batch number has been requested.
Pt recvd vax & 23APR93 pt devel malaise, low grade fever & generalized fine rash; presented to a hospital where a MD felt had rubella;