chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Narrative: Pt received 1 dose of COVID-19 vaccine (Pfizer) on 08/30/2021. About 3 weeks later, admitted for chest wall pain. Unclear duration of CM, possibilities include viral myocarditis (w/ related viral PNA), vs ETOH-mediated vs COVID vaccine myocarditis, or other. Less likely ischemic w/ young age. Per the ID note, "The primary suspicion is that his CHF is due to a viral myocarditis due to Coxsackie. We have considered COVID vaccination as a potential contributing cause of his symptoms. However, typically mRNA vaccine related myocarditis occurs after the second dose and typically occurs within a few days of the vaccination. His presentation is not consistent with the vast majority of presentations. By criteria, it would only fit as possible association. Overall, he remains not fully vaccinated and his risk of COVID complications is high. We recommend that he get the J&J / Janssen vaccination which is not associated with myocarditis and would offer greater protection than one mRNA vaccine."
This spontaneous prospective pregnancy report as received from a medical assistant refers to a 17 years old female patient. The patient's history of previous pregnancies and live births is not known. The patient was vaccinated (route unknown) with dose 1 GARDASIL (lot number and expiry date not reported) on 18-AUG-2011. No other co-suspects were reported. No concomitant medications were reported. Subsequently, the patient became pregnant with an LMP of NOV-2012. Initial exposure to GARDASIL was at 0 week(s). The patient was exposed to GARDASIL during trimester 1. On 14-DEC-2012 the patient received her first dose of GARDASIL on 18-AUG-2011 and the second on 14-DEC-2012, 119 days after onset of therapy. A recent pregnancy test was positive. Pregnancy is normal to date. No treatment information was reported. The outcome of received her first dose on 08/18/2011 and the second on 12/14/2012 and pregnant is unknown. Received her first dose on 08/18/2011 and the second on 12/14/2012 and pregnant is not related to GARDASIL. Additional information has been requested.
I had ongoing issues from when I had COVID-19 but those symptoms progressively got worse. Symptoms like blurred vision & hearing. The headaches subsided in June 2022. I also had the blurred vision during COVID-19. I also experienced nerve pain, dizziness, and vertigo type symptoms. I had congestion as well. The vertigo symptoms made it hard to drive or walk. I reached out to my doctor who completed blood work on October 15, 2022. I am supposed to see a neurologist for nerve pain. I was prescribed FLONASE for the phlegm. I am also scheduled to see an ophthalmologist and to have a sleep study. The vertigo comes and goes but the blurred vision is constant.
1st covid vaccine given on 1/18/21, 2nd covid vaccine given on 2/8/21.   On 2/17/21 I was experiencing mild shortness of breath, but did not seek medical help as the symptoms would come and go and were not severe.  On 2/22/21 I had an outpatient hernia repair surgery.  On 2/23/21, I began experiencing shortness of breath and dizziness on exertion.  This continued throughout the next many days.  On 3/1/21 I had sudden onset of dizziness, tachycardia, shortness of breath.  I was admitted to the hospital with bilateral DVT and PE.
Resident tested positive for COVID on 01/11/2021. Resident received out patient monoclonal antibody treatment on 01/12/2021.
Initial unsolicited report received from healthcare professional (Regeneron Medical Specialist) on 03 November 2016. This case involves a 50-year-old male patient (age reported as In 50s) who was vaccinated with dose of INFLUENZA VACCINE (FLU SHOT) and one inection of ALIROCUMAB (Praluent injection) (batch number, expiration date, site and route of administration was not reported for both) on an unspecified date. Medical history and concomitant medication was not reported. On an unspecified date patient experienced "fatigue and felt achy" approximately six days after first Praluent injection and it was reported that patient received a flu shot "just prior to symptom onset. Lab data and corrective treatment were not reported. List of documents held by sender: none.
Mild cold symptoms. 2/12 positive on at home COVID-19 test. Televisit with doctor who prescribed LAGEVRIO. No fever, sore throat, one day of fatigue. Some congestion and sore throat lingered for a few days and then cleared up.
sore arm at injection site; achy joints; tiredness; headache; Low grade fever; Maternal exposure during breast feeding; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore arm at injection site), ARTHRALGIA (achy joints), FATIGUE (tiredness), HEADACHE (headache) and PYREXIA (Low grade fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Pregnancy (Patient recently gave birth. She received first two doses during first trimester.). Concurrent medical conditions included Breast feeding.    On 02-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Nov-2021, the patient experienced MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding). On an unknown date, the patient experienced VACCINATION SITE PAIN (sore arm at injection site), ARTHRALGIA (achy joints), FATIGUE (tiredness), HEADACHE (headache) and PYREXIA (Low grade fever). On 02-Nov-2021, MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding) had resolved. At the time of the report, VACCINATION SITE PAIN (sore arm at injection site), ARTHRALGIA (achy joints), FATIGUE (tiredness), HEADACHE (headache) and PYREXIA (Low grade fever) outcome was unknown. Not Provided          No concomitant and treatment medication were provided Patient received first two doses during her first trimester and currently breast feeding.  This case concerns a female patient, of unknown age, with no relevant medical history, who experienced vaccine exposure during breast feeding with associated expected, non-serious events following administration of the third dose of the Moderna COVID-19 Vaccine on 02Nov2021. The start dates of the events were not provided. The rechallenge was not applicable as no additional dosing will be given. The benefit-risk relationship of the Moderna COVID-19 Vaccine is not affected by this report.   This case was linked to MOD-2021-376688 (Parent-Child Link). This case was linked to MOD-2021-004191 (Patient Link).   See case MOD-2021-376688 for details regarding the child case.; Sender's Comments: This case concerns a female patient, of unknown age, with no relevant medical history, who experienced vaccine exposure during breast feeding with associated expected, non-serious events following administration of the third dose of the Moderna COVID-19 Vaccine on 02Nov2021. The start dates of the events were not provided. The rechallenge was not applicable as no additional dosing will be given. The benefit-risk relationship of the Moderna COVID-19 Vaccine is not affected by this report.
12hrs after shot: Headache (10 of 10), Fever (HIGHEST 102.8) body ache, chills, weakness, tiredness, swollen lymph node in left axillary area took Tylenol 500mg x2  every 6 hrs up to today. Unable to go to work for next 2 days, only went to work on 3d day (with fever99.9, headache, weak) could not afford to pay out of pocket for dr visit. Left arm still very red, warm to touch, SWOLLEN, PAINFUL on day #3. Was positive for Covid with pneumonia 4 Mar 2021 with very bad symptoms lasting 10 days.
One week post vax pt was seen in the physician's office and diagnosed with full blown chickenpox. Pts body was entirely covered with an unknown number of lesions. Lesions were infected and pt was treated with Bactroban, Tylenol and calamine. Additional information has been requested.
1 1/4 x 3/4 induration on (local) injection site.
This spontaneous report was received from a physician via two company representatives and from a practice manager (support services director) and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 18-MAR-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 0.5 ml injection, lot # K005402, expiration date 07-NOV-2015 (dose, route and site of administration were not reported). The administered dose of vaccine was exposed to the following temperature excursions (dates unspecified): the first lasting for 24 hours, with the highest recorded temperature of 47.5 degrees Fahrenheit, the second lasting for 24 hours, with the highest recorded temperature of 46.3 degrees Fahrenheit, the third lasting for 372 hours, with the highest recorded temperature of 59.9 degrees Fahrenheit, the fourth lasting for 24 hours, with the highest recorded temperature of 48.1 degrees Fahrenheit, the fifth lasting for 96 hours, with the highest recorded temperature of 47.2 degrees Fahrenheit, the sixth lasting for 96 hours, with the highest recorded temperature for 46.8 degrees Fahrenheit, the seventh lasting for 24 hours, with the highest recorded temperature of 46.6 degrees Fahrenheit, the eighth lasting 24 hours, with the highest recorded temperature of 46.2, the ninth lasting for 36 hours, with the highest recorded temperature of 48.2 degrees Fahrenheit. The vaccine was stored in a refrigerator. No adverse effects were reported. There was no product quality complaint involved. This is one several reports received from the same reporter. Additional information has been requested.
Pt recvd 3 doses of Engerix-B & 1st dose was administered in early 1990; 3rd dose was administered in the summer 1990; 11NOV91 pt exp non-response; no tx was given;
Flu like symptoms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 20Oct2021 02:00 (Lot number: EW0217) at the age of 58 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing). Concomitant medication(s) included: FLU. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EL3247, Location of injection: Arm Left, Route of Administration: Intramuscular, No Events reported), administration date: 25Feb2021, when the patient was 58 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3247, Location of injection: Arm Left, Route of Administration: Intramuscular, No Events reported), administration date: 02Feb2021, when the patient was 58 years old, for Covid-19 immunization. The following information was reported: INFLUENZA LIKE ILLNESS (non-serious) with onset 21Oct2021 11:30, outcome "not recovered", described as "Flu like symptoms". Therapeutic measures were not taken as a result of influenza like illness.  Additional Information: Flu like symptoms includes headache, chills and achiness.  Facility where the most recent COVID-19 vaccine was administered was Workplace clinic. No allergy reported. Prior to vaccination, patient was not diagnosed with Covid-19. Since the vaccination patient has not been tested for Covid-19.  Follow-up attempts are completed. No further information is expected.
Case number PHHY2011US35447 is an initial report from a health care professional received on 25 Apr 2011 with a follow up from physician received on 28 Jun 2011: This report refers to multiple patients. Three patients received MENVEO (batch number A10027) intramuscularly on an unspecified date. These patients received MenCWY liquid conjugate component without reconstitution with MenA component. None of the patients experienced any adverse event.
24 hours after vaccination swelling began on the right jawline. It started a roll under the skin. It progressed to ear and ear was painful. Client went to the clinic 10/31/22 for the ear pain. She also had  a acne breakout on forehead on her right forehead on the day of vaccination too. FNP thought it was swelling due to vaccine and recommended watchful waiting. 11/1/22 client developed sever HA for whole head which OTC analgesics did not help. 11/2/22 swelling increased to include all of right face including eye. No swelling to L side noted. Went back in to clinic 11/2/22 and was started on metronidazole and levofloxacin for paroditis. Swelling continued and client returned to Health facility later the same day and got a steroid injection. Swelling has not improved. Redness is noted on the forehead area since 10/28/22 and at the jawline on 10/31/22.Client has no fever,. Skin is warm where the redness is.
patient reported symptoms of: local redness, excessive swelling/edema wrapping around almost entire upper arm, heat, headaches, dizziness, lethargy
4 yr old male in for school shots on 08/26/2002. Mom noticed large red, swollen, feverish area on left thigh on 08/28/2002. Went to ER and saw ER DR. Was told to put Cortisone cream on area, use ice packs and cool cloth. Gave Benadryl this am 08/29/2002. Mom says dad told her itis better today 08/29/2002.
Eyes color changed to red; Pain in my legs muscles, chest and jaw; Pain in my legs muscles, chest and jaw; Acute allergic reaction to flu vaccine; Pain in my legs muscles, chest and jaw; Blood pressure was around 160; This is a spontaneous case, reported by other non-health professional to agency [reference number: SEQ19-06089] and initially received on 04-Nov-2019, concerning a 53-year-old, male patient.   The patient's relevant medical history included flu vaccination with other brands for more than 10 years with no adverse events. The patient was not taking any concomitant medication.  On 04-Oct-2019 at 4:30 pm, the patient was administered Afluria Quadrivalent [influenza vaccine, NDC: 33332-419-11; dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: P10011060 and expiration date: 15-May-2020] for prevention of seasonal influenza.  On the same day, an hour after vaccination, the patient experienced pain in leg muscles, chest and jaw, and the patient's eyes colour changed to red.  On the same day, the patient went to hospital emergency room and underwent electrocardiogram (EKG), chest X-ray and had blood tests done, however, results were not provided. The patient's blood pressure was around 160, units were not specified. It was reported that the patient was diagnosed with acute allergic reaction to flu vaccine. The patient received treatment medicine prednisone at a dose of 20 mg, administered once per day, for 5 days (5 tablets).  On 05-Oct-2019, the patient's blood pressure went to normal, and the patient was discharged home.  At the time of the initial reporting, the outcome for the events of pain in legs, chest pain, pain in jaw, red eyes and acute allergic reaction was not reported.  The case was assessed as serious.   The reporter assessed the events to be related to Afluria Quadrivalent.  This case is linked to cases 201905876, 201905877 and 201905878 (same reporter).  Company comment: The patient experienced pain in jaw, blood pressure increased, ocular hyperaemia, chest pain, pain in extremity and hypersensitivity an hour after vaccination with the suspect product Afluria Quadrivalent. Chronology is plausible. No diagnostic findings and concomitant medications were provided. Considering all the above mentioned, causality between suspect product and the events is assessed as possibly related.; Reporter's Comments: They recognized this is acute allergic reaction to flu vaccine.; Sender's Comments: The patient experienced pain in jaw, blood pressure increased, ocular hyperaemia, chest pain, pain in extremity and hypersensitivity an hour after vaccination with the suspect product Afluria Quadrivalent. Chronology is plausible. No diagnostic findings and concomitant medications were provided. Considering all the above mentioned, causality between suspect product and the events is assessed as possibly related.
Swollen arm, chills, fever, nausea, lightheaded, dizziness,  aches, coughing, running nose, fatigue
Patient is fully vaccinated.  COVID positive 12/30/2021 at ED visit. She has had 3 days of rhinorrhea, ST, cough, chest tightness.+ sick contacts. Now with altered sense of smell. BP 108/52  | Pulse 79  | Temp 98.2 °F (36.8 °C) (Oral)  | Resp 17  | Ht 167.6 cm (5' 6")  | Wt 63 kg (139 lb)  | SpO2 98%  | BMI 22.44 kg/m² CXR neg. Labs ok. Conservative tx for covid. Discharged from ED.
On 04/20/2000 the patient received his 3rd dose of Lymerix. Reportedly, he "did well" until approximately late April 2001 or early May 2001, when he began to experience headaches, fatigue, and red patches on his torso and legs. His symptoms were never evaluated by a physician. Reportedly, every week after the beginning of May, a new symptom would develop. One day "pinky edema, next morning finger edema" appeared to develop in the middle joints of fingers. The patient stated that the edema traveled to his left knee then to his shoulders. The patient experienced pain. The adverse events "headaches, joint edema, and joint pain" do not meet ICH serious criteria, but are being submitted as an expedited report by special FDA request per the 06/28/2000 letter.
Approximately one week later, a mild rash occurred below injection site which has persisted to this day. Did not itch, but felt hot to the touch.  It becomes much redder after showering.
Headache, Myalgia & Arthralgia Narrative:  Immediate symptoms, as marked and, of profound fatigue, nasal and chest congestion, and low back pain which lasted 72 hours as  it did after the 1st vaccine.  Other Relevant History:
This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 01-FEB-2018, the patient was vaccinated with an expired dose of  GARDASIL 9 lot # M007764, expiration date 30-JAN-2018, for prophylaxis (dose and route of administration were not reported). There was no adverse effect reported. No product quality complaint was involved.
pt recv vax 8FEB96 & pt began screaming;tx w/APAP w/o much response;also devel an inj site rxn, which was red & hot to touch;
It jumpstarted my period start date. Broke out with acne. Mainly wanted to record this so that there's more a trace on side effects.
started developing a rash on his stomach, back, and legs/the rash was on his body, tummy, legs and back; his hands and legs were itchy/there were patches which were itchy also; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 9 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 05Jan2022 (Lot number: FL8095) at the age of 9 years as dose 1 (tris), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: RASH (non-serious) with onset 07Jan2022, outcome "recovered" (2022), described as "started developing a rash on his stomach, back, and legs/the rash was on his body, tummy, legs and back"; PRURITUS (non-serious) with onset 07Jan2022, outcome "unknown", described as "his hands and legs were itchy/there were patches which were itchy also". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of rash, pruritus.  Additional information: Reporter was stated that Pediatric Covid vaccine first dose. Stated that his twin sons got the first dose 05Jan2022 in the evening at withheld. Stated that one twin was fine. Stated that the other twin had rashes two days after the vaccine. Stated that on 07Jan2022 or 08Jan2022 that he had rashes on his body and tummy. Stated that he got itchy legs and had rashes in middle of night and applied coconut oil. Stated that he was itchy because of the weather. Stated that he was in the cold and snow and two the three hours later his son showed him some rashes and he thought maybe the temperature could be causing the itchiness. Stated that later in the night that his hands and legs were itchy and it went away. Stated that there were patches which were itchy also. Stated that he was talking to friends and they reported similar rashes and hives with the booster dose of Moderna. Wanted clarification if his son should get the second dose which is scheduled for the last week of Jan2022. Provided the lot: FL8095. Stated that it was administered at withheld. Later clarified that it was Pfizer Pediatric Covid vaccine (5-11). Stated that he had Covid testing before the vaccine on 29Dec2021 or 30Dec2021. Height was 48 to 50 inches. Weight was 80 pounds plus or minus two or three pounds. Reporter was stated that the rashes started on 07Jan2022 or 08Jan2022. Later clarified that the rash was on his body, tummy, legs and back. Stated that the rash on his body subsided in 8-10 hours. Stated that the rash on his legs subsided in a couple of hours. Stated that the rash on his tummy and back started first and subsided the same day. Treatment was stated that he applied coconut oil to the rashes on his legs and body.  Follow-up attempts are completed. No further information is expected.
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 16-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Dec2021 at 13:30 as dose 3 (booster), single (Lot number: 330303D) at the age of 16 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.
DIARHHEA AND FEVER BEGINNING 48 HOURS AFTER VACCINATIONS AND CONTINUING FOR MORE THAN 72 HOURS;
Patient complained of sore under tongue that presented 2 days after receiving vaccine. Patient was following up with PCP for further evaluation. She also complained of other "normal" adverse events of headache, chills, and generally just not feeling well.
PARTIAL DOSE ADMINISTERED; This spontaneous report received from a pharmacist concerned a 31 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 203A21A expiry: 23-JUN-2021) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced partial dose administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of partial dose administered was not reported. This report was non-serious.
Donor has red raised area w/ hard nodule, warm to tough, soreness upon touch.  Donor states she felt tired for 2 days after shot.