chrisvoncsefalvay/vaers-outcomes huggingface dataset:
8/8/02 mother called and states "RT arm (injection site)sl. red and hot to touch." She described a "uarter-sized area." Dr. notified and told to use Benadryl and cold compresses-if sx persist or worsen to f/up with him. Mother verbalized understanding. 8/9/02 child came to see Dr. Rt arm red, warm to touch and inflammed arm about the size of a lemon noted. Child in no distress and no c/0 pain. Meds/instructions given per Dr.
Information has been received from a physician's assistant concerning an 18 year old female who on 23-JUL-2007 was vaccinated with a first dose of GARDASIL  0.5 ml IM. On 04-JAN-2008 the patient was vaccinated with a third dose of GARDASIL 0.5 ml IM. Concomitant therapy included hormonal contraceptives (unspecified) and metronidazole. On 23-JUL-2008 the patient developed calcified hematoma on her left arm that was discovered after her third dose of GARDASIL . The patient's calcified hematoma persisted. The patient sought unspecified medical attention. Follow-up information was received from the physician's assistant who reported that the patient was a Caucasion student who had irritable bowel syndrome and polycystic ovarian syndrome.  On 23-JUL-2007 and 04-OCT-2007 she was vaccinated with first and second doses of GARDASIL in her right deltoid respectively.  Subsequently, the patient developed a semi-solid subcutaneous mass.  On 04-JAN-2008 at approximately 3:15 PM, the patient was vaccinated with a third dose of GARDASIL i her left deltoid.  There was not illnesses ath the time of vaccination.  On 04-JAN-2008 the patient developed an apporoximately grape-sized, semi-solid subcutaneous mass under the injection site.  At the time of this report, the event persisted. Additional information is not expected.
This spontaneous report was received from a consumer referring to an 80 year old male patient with Parkinson's disease, and pituitary tumour. On 01-OCT-2015, the patient was vaccinated with a dose of PNEUMOVAX (manufacturer unknown) (lot # and expiry date not reported). On the same day the patient was vaccinated with a dose of influenza virus vaccine. Concomitant therapies included ramipril, 5 mg once a day, simvastatin (manufacturer unknown), 20 mg once a day, metoprolol succinate extended release, 50 mg once a day, and aspirin, 81 mg once a day. On 01-OCT-2015, the patient underwent blood work before the vaccinations doses were given to him, but he was not having the results. He had CBC with differential platelet, lipid panel with HDL:LDL ratio, and comprehensive metabolic panel 14. On 02-OCT-2015, the patient experienced at the arm with PNEUMOVAX (manufacturer unknown) shot had a bad reaction to it, it was all red, swollen and spots all over his shoulder on his arm, and he did not feel well. The outcome of limb discomfort, malaise, rash macular, peripheral swelling and erythema was unknown. Additional information has been requested.
Narrative:  Denies bLast Wednesday, 0830, COVID vaccine at clinic.  Thursday at 1200 started w/ sxs: loss of taste or smell, total body muscle aches.  1700 felt feverish, measured temp. 104, messaged sister, told to take tylenol, did not take the tylenol and went to bed. Woke up at 1600AM the next day (Friday Am) with sheets saturated 2/ sweat & diarrhea watery/liquid x 3. Friday AM T 98.4. All sxs were resolved. Denies being around any persons unmasked, lives alone, n/vomiting, no known confirmed positive COVID contacts, rash, facial swelling/tongue swelling.
COVID-19; Vaccination faliure; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) injection for Psoriatic arthritis.    Concurrent medical conditions included Psoriatic arthritis.   On 01-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Sep-2021, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram every two weeks. On 28-Nov-2021, the patient experienced COVID-19 (COVID-19) (seriousness criterion hospitalization). On an unknown date, the patient experienced VACCINATION FAILURE (Vaccination faliure). The patient was hospitalized on 28-Nov-2021 due to COVID-19. At the time of the report, COVID-19 (COVID-19) and VACCINATION FAILURE (Vaccination faliure) outcome was unknown.            This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  No concomitant medication information was  provided.  It was reported that the patient remained in hospital as of 16-Dec-2021.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No treatment medication information was provided.  Company Comment: This is a spontaneous case concerning a 62-year-old male patient with no relevant medical history, who was hospitalized due to the unexpected, serious adverse event of special interest of COVID-19, approximately 5 months after receiving the second dose of mRNA-1273 vaccine. Vaccination failure was also reported as an additional event. Clinical course, diagnostic tests and treatment details were not provided in the case. The outcome of the event was unknown at the time of the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 62-year-old male patient with no relevant medical history, who was hospitalized due to the unexpected, serious adverse event of special interest of COVID-19, approximately 5 months after receiving the second dose of mRNA-1273 vaccine. Vaccination failure was also reported as an additional event. Clinical course, diagnostic tests and treatment details were not provided in the case. The outcome of the event was unknown at the time of the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.
First dose was received on 26Jul2021 and second dose was received on 14Oct2021; I have been bleeding so much too, it lowered my hemoglobin; heavy menstrual cycle lasting over 17 days; Almost got me a block heart; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (004756). The reporter is the patient.  A 32 year-old female patient received bnt162b2 (COMIRNATY), administration date 14Oct2021 03:00 (Lot number: EW0151) at the age of 31 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE: 1, time was 2 O' clock), administration date: 26Jul2021, when the patient was 31 years old, for COVID-19 immunization. The following information was reported: MENSTRUAL DISORDER (non-serious) with onset Oct2021, outcome "unknown", described as "heavy menstrual cycle lasting over 17 days"; ATRIOVENTRICULAR BLOCK (non-serious) with onset 2021, outcome "unknown", described as "Almost got me a block heart"; HAEMOGLOBIN DECREASED (non-serious) with onset Oct2021, outcome "unknown", described as "I have been bleeding so much too, it lowered my hemoglobin"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 14Oct2021, outcome "unknown", described as "First dose was received on 26Jul2021 and second dose was received on 14Oct2021". The events "heavy menstrual cycle lasting over 17 days", "almost got me a block heart" and "i have been bleeding so much too, it lowered my hemoglobin" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of menstrual disorder.  Additional information included: The patient did not start missing it, she had very strong menstrual heavy cycle for over 17 days. She was bleeding for atleast 10 days. It real came back to the point that she ended up in the hospital. She was put on a medication (Tranexamic acid 650mg, NDC number - 255926530, three times a day, medication for 5 days) to try and stop the heavy menstrual cycle which did not work, which almost got her a block heart. She was bleeding so much too, it lowered her hemoglobin. So, that's why she was trying to figure out what's actually in the vaccine because she had an appointment with her OB-GYN at 1:30. So, she could discuss with him the ingredients that was actually in the Pfizer so, doctor could treat her accordingly. The patient did not take any prior vaccination (4 Weeks).  No follow-up attempts are possible. No further information is expected.
fever 103 x 48hrs;unconsolable crying for 48hrs;local redness & swelling very diffuse
Client was vaccinated with the J&J on 4/3/21 and had a breakthrough infection on 4/23/21.
Two days later on 27feb2021, intense itching and pain under both arm pits for 2 days and it subsided to mild itching for 2 months and then it went away. 01March saw the doctor.
Itchiness and rash on left side of body. Rash went away after 2 days but itchiness continues for 5 days
This spontaneous report was received from a registered nurse regarding a patient of an unknown age. Information on the patient's relevant medical history, concurrent conditions and concomitant medications were not reported. On 03-DEC-2018, the patient was vaccinated with measles M-M-R II that was reconstituted with expired sterile diluent (lot# M009800, expiration date: 12-SEP-2018) (expired product administered) for prophylaxis. No adverse effects was reported (no adverse event). There was no product quality complaint. Sender's Comments: US-009507513-1901USA009966: US-009507513-1901USA007603: US-009507513-1901USA009967.
LONG-STANDING FEVER, HEADACHES, WEAKNESS - LASTED 5 DAYS
Joint aches; This is a spontaneous report from a non-contactable consumer or other non hcp.   A 64-years-old male patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot number: not reported), via an unspecified route of administration on 19Mar2021 12:45 (at the age of 64-year-old) as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient had not diagnosed with COVID-19. The patient has not tested for COVID-19 since the vaccination. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. On 20Mar2021 18:00, the patient experienced joint aches. Patient has not received any treatment for the event. The clinical outcome of the event was recovered on unknown date in 2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.  Amendment: This follow-up report is being submitted to amend previously reported information: Protect Confidentiality unticked since reporter is not patient, reported for the patient added in narrative and final sentence was updated as "No follow-up attempts are needed; information about lot/batch number cannot be obtained".
This case was reported by a physician via sales rep and described the occurrence of swelling in a male patient who received BEXSERO. On an unknown date, the patient received BEXSERO at an unknown dose. On 24th October 2017, unknown after receiving BEXSERO, the patient experienced swelling, induration and mass. On an unknown date, the outcome of the swelling, induration and mass were unknown. It was unknown if the reporter considered the swelling, induration and mass to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. The reporter reported on behalf of physician and reported that he went in today and gave her the label update for BEXSERO with post-marketing experience and she said she had two patients with extensive swelling and the persistent hard lump, a boy and a girl. That was all the information she could remember but asked to feel free to reach out to her and contact her if would like. This case is linked with case US2017GSK164004, reported by the same reporter.
Patient reported adverse reactions: painful and large swollen area  in his armpit and on the side of chest area. Headache and discomfort.
Within a couple minutes of receiving the seasonal flu mist for the first time, he c/o LUQ stomach ache, "spine hurting", dizziness and head burning. He appeared dazed and weak but ambulatory. Vitals stable other than tachypnea. No wheezing, angioedema or urticaria. Lung clear. He was observed for about 30 minutes during which most symptoms seemed to have resolved. It appears to me that he had some sort of reaction (stomach ache and back pain) that led him to hyperventilate making him feel even worse.
Patient received Pfizer 5year-11 year covid vaccine in error, instead of Moderna 6month-5 year vaccine.
Patient in his usual state of health received COVID-19 vaccine, dose #1, and approximately 5 hours later, started having LEFT upper and lower eyelid edema. He has never had anything similar.  No pain, no blurry vision or double vision, no redness or warmth of the site.  Seen in the ED and discharged with suggestion to give benadryl and use cold compresses to help with the swelling.  Dad states they gave 2 doses of benadryl and used the cold compresses. The swelling was resolved by the following morning.  No other symptoms.  No fully resolved on clinic follow-up today 11/22/2021.
Developed 5 x 4 cm edema & fine area of erythema, distal to the site. Vaccine given at outside site.
inadvertently given vaccine from a vial that was punctured a day before; A spontaneous report was received from a physician regarding a 22-year-old male patient who inadvertently received Moderna's mRNA-1273 vaccine from a vial that was punctured the day before/expired product administered.  The patient's medical history was not provided. Concomitant medications were not provided.   On 13 February 2021, the patient received the first of two planned doses of mRNA-1273 (Batch: 016M20A) intramuscularly for prophylaxis of COVID-19 infection.  On 13 February 2021, it was noticed that the vial being used had been punctured the day before, beyond the 6-hour expiration.  Treatment information was not provided.  Action taken with mRNA-1273 was not provided.  The outcome of the event, inadvertently given a vaccine from a vial that was punctured the day before, was considered resolved.; Reporter's Comments: This case concerns a 22-year-old male patient who received their first of two planned doses of mRNA-1273 (Lot: 016M20A), reporting Expired product administered without any associated adverse events.; Sender's Comments:  MOD-2021-013965:same reporter, different patient MOD-2021-013964:same reporter, different patient
marked erythema, warmth, induration & swelling of rt upper arm;area 7 x 10cm in size;treated w/Ibuprofen;
Rash with puritis started 7/18/2007. Initially mother thought they were bug bites. Mother describes as red raised bumps with white spots in middlesome as big as 1/4" across on arms, legs and back. Benadryl given and not real helpful, decreased itching somewhat. some have faded. Four other siblings with similar rash. One received Tdap, one Recived Td, and two received DTaP
¨Potential AE ¨as CC reported; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (¨Potential AE ¨as CC reported) in a  patient of an unknown age and gender 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) 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT (¨Potential AE ¨as CC reported). At the time of the report, ADVERSE EVENT (¨Potential AE ¨as CC reported) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication not provided and Treatment medication not reported   Reporter did not allow further contact
Severe abdominal cramping, explosive diarrheas for 1 hour, nausea, headache, tired.
Soreness in arm.  Normal expected soreness at first.  Once I got home from work it was different.  Much more painful from my shoulder to my elbow.   The part I find concerning is my inability to lift my left arm.  I try and I literally can not lift it.  It is as if those muscles just don't want to work.  I am able to force it to a degree, but it causes extreme pain.  I expect this will improve over the next couple days.  If not, I will call my doctor.  I also woke up this morning feeling cold symptoms.  Fatigue, scratchy throat, post nasal drip, and general "yuck" feeling.  I had something similar occur the very first time I ever had a flu shot and was fine by lunch and then never had that again, so I assume this may be the same.  I did start getting a headache within an hour of receiving the vaccination, but it went away with 800mg of ibuprofen.
It began with right arm soreness and progressed to aches and low grade fever within the first 24 hours. Then it moved on to mid-sternal chest pain that radiated to my back and I had shortness of breath that increased with deep breathing after about 48 hours.
Severe pain in the injection side shoulder. Not the injection site but rather the whole shoulder. The pain is constant but more severe at night in bed. It is very painful for me to roll over in bed. It is difficult to raise my arm.
Some soreness of the injected arm; This case was reported by a consumer and described the occurrence of pain in arm in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In August 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 5 months after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient had received the vaccine around August,2020 on an unknown arm and she had some soreness of the injected arm. The reporter consented to follow-up. For tolerance to the 2nd dose of Bexsero, refer case US2020248584.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020215496:same reporter (husband´s case) US-GLAXOSMITHKLINE-US2020AMR249184:same reporter US-GLAXOSMITHKLINE-US2020248584:same patient (2nd dose)
Grandfather called clinic on 8/16 with a report of granddaughter having a "rash" and redness to left leg and chest.  Description was "redness that started around neck and faded away at chest." Denied having individual lesions, nothing on head.  Did not come into clinic for staff to observe.  Staff encouraged grandfather to take granddaughter to Health Center for evaluation if rash worsened or if he had other concerns. He stated his wife was immunocompromised but didn't know why.  Reported hx of anaphylaxis reactions to soda ash.  Grandfather stated he would seek care if rash worsened.
began 24 hours after injection. Hot to touch round, red rash with a knot under skin. Chills with body temp of 98.6F. Body aches and could not get out of bed for 2 days. Chest tightness and trouble breathing.
Vaccine administered past vaccination date (expired 10/01/23 and administered in error on 10/17/23)
Patient tested positive for COVID-19 an had typical respiratory symptoms the week prior to admission, which resolved. His admission was prompted by a week of increased diarrhea- 8x/day with blood mixed in, associated with some chills, nausea, and weight loss. He did not require supplemental oxygen or COVID-19-specific therapies.
Patient presented with a bruising at injection site. She said the injection felt different than it normally has felt in the past. She said she felt as if she could feel the vaccine being injected. Her bleeding was more than normal and the pharmacist had to put on several band aids to stop the bleeding.
Itchy rash at the injection site; Itchy rash at the injection site; Headache; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PRURITUS (Itchy rash at the injection site), INJECTION SITE RASH (Itchy rash at the injection site) and HEADACHE (Headache) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included LORAZEPAM, MULTIVITAMINS [VITAMINS NOS] and LISINOPRIL for an unknown indication.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Implant) 1 dosage form. On 02-Feb-2021, the patient experienced INJECTION SITE PRURITUS (Itchy rash at the injection site), INJECTION SITE RASH (Itchy rash at the injection site) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, INJECTION SITE PRURITUS (Itchy rash at the injection site), INJECTION SITE RASH (Itchy rash at the injection site) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Implant) was unknown.       No concomitant medications reported by investigator   Most recent FOLLOW-UP information incorporated above includes: On 19-Apr-2021: Follow up received on 19APR2021, No new information invalid contact details
Snoty nose; cough; sore arm that swelled to size of base ball; loss of smell; heaviness in joints; sore arm that swelled to size of baseball; This is a spontaneous report from a contactable other HCP (patient).   A 26-years-old (non-pregnant) female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: unknown) via an unspecified route of administration, administered at right arm on 24Feb2021 at 12:15 PM (at the age of 26-year-old) as dose 2, single for COVID-19 immunisation. The patient medical history included TBI, epilepsy, non epileptic seizures, post-traumatic stress disorder and ADHD (from an unknown date and unknown if ongoing for all medical history). The patient had known allergies with sulfa mild allergy. The patient's concomitant medications included lamotrigine (LAMICTAL) for an unspecified indication from an unknown date (in two weeks of vaccination) and unknown if ongoing and venlafaxine for an unspecified indication from an unknown date (in two weeks of vaccination) and unknown if ongoing. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on an unknown date as dose 1, single for covid-19 immunisation. On 27Feb2021 at 17:00, the patient experienced snoty nose, cough, sore arm that swelled to size of baseball, loss of smell, heaviness in joints. The patient received no treatment for adverse event. The patient did not receive other vaccines prior to the COVID vaccine. The patient had not Covid tested post vaccination. The outcome of the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot been obtained
4pm - nausea & fatigue; 7pm - severe acute headache, muscle aches;  2/5/21  3am-10am - sore arm, full body aches, fever ranging from 100-102 degrees Fahrenheit, chills