chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I was having a painful nodule in my armpit on the left side which is the arm that I got my COVID-19 shot it in. It was red, painful, very sore, and I really noticed this as I was taking as shower and lifting my arm to wash it. It was about two or three weeks after I got the shot that this really became noticeable. I had an upcoming appointment with my dermatologist and so when I went in on February 27th I addressed. the nodule or cyst that was present. At this point the soreness had subsided but the nodule itself was still present. The provider I saw was the PA and they have said they wanted to do a follow up with the doctor which I have on April 4th. The PA called it a cyst and at this point we have not done testing on it, but the concerns are that it may need to be surgically removed and it is worrisome because the cyst is located in an area where there are lymph nodes.
writing this to report patient was administered  maufacturer exp 10/23/21 but 30 day must use of refrigeration  is 9/19/21 moderna syringe was labeled accurately  Moderna lot # 025c21A exp 9/19 Clinician administered dose at 0832 on 9/20/21 RN onsite manager made aware pharmacist made aware Dr. made aware by RN onsite manager and RN Director made aware by RN onsite manager
very bad headache, body aches and soreness from over night aching.  chills over night but no noticeable fever.  tylenol helped with the severity of the aches.  took tylenol again before bed and had a much better nights sleep.  still a slight headache the second day afterwards.
At 1140, RRT was activated for a 34 y/o M that passed out for a few seconds. He stated, ?I felt like I was in a dream.? His eyes rolled back before passing out. When he was alert after his fainting episode, he stated that his right arm was numb and had c/o nausea, weakness, a brief moment of blurry vision, and ?feeling hot?. Head-to-toe assessment completed. Client was diaphoretic and pale. Client also reported that he was feeling hot and then feeling cold all of a sudden and this was ongoing.  Client vaccinated on the R arm at 1130. NKA, no past medical hx. Does not take any medications but smoked marijuana just prior to his appointment. Vitals ? BP: 138/98, RR: 20, HR: 65, 0/0 pain. EMS called. Client?s condition improved during monitoring period but as EMS arrived, client began to feel same symptoms again but did not pass out. EMS arrived at 1149. Vitals when they arrived were: BP: 142/77, HR: 48. Client?s condition did not improve significantly but did not get worse. Client opted to have ambulance transport to Community ER to be further evaluated and treated. Client left vaccination clinic via Representative, accompanied by Fire Engine and unit @ 1200. Girlfriend, who came with client, followed client to hospital. Client left in stable condition, AA0x4, breathing even and unlabored, in no acute distress.
7 days after my 2nd Covid vaccine a rash started to appear on my upper chest/rib cage area. The rash got significantly worse over the next 2 days so I scheduled a tele-doc appointment. He confirmed the rash was Shingles. I had a mild case of chicken pox as a child and I am only 37 so it was surprising to get Shingles. While I cannot say if it is related to the vaccine, I wanted to make sure it was reported.
Extreme nausea  could not keep nothing down for 2 days , headaches,  sweats, Lightheaded, this is day 6 starting to feel a lot better but still not myself
It started the extreme nausea and vomiting, itching all over and it lasted for about three weeks.
Information has been received from a certified medical assistant concerning two patient who were vaccinated with PNEUMOVAX 23. Subsequently the patients experienced cellulitis-like reactions. The patients were treated with an antibiotic. At the time of the report it was unknown if the patients recovered. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available. In follow-up it was reported by the physician that a patient with no pre-existing allergies, birth defects, or medical conditions was vaccinated intramuscularly in the a.m., on approximately 26-JAN-2007, with PNEUMOVAX 23, (Lot # 651406/0620F). It was reported that the patient had a localized cellulitic-like reaction. The patient had a clinical exam only. It was reported that the patient recovered. The reporter stated that there were three other patients that had localised cellulitic-like reactions after receiving the PNEUMOVAX 23, (WAES # 0711USA03296, # 0711USA03297, 0711USA03298). Additional information has been requested.
Details unclear: case reported today.  Patient was scheduled for surgery, but during pre-op stated he tested positive for COVID-19 at a pharmacy, test date unknown. Patient returned 26 Jul 2021. Patient reports a sore throat, and states he notified his supervisors.
Severe rash (hives) developed 6 days after flu vaccination.  Started on knees and elbows, and spread to legs and feet.  Patient applied hydrocortisone cream on affected areas and took oral Benadryl every 4 hours.  Rash significantly reduced after 24 hours.
Edema, pruritis on upper arm one day following immunization. No loss of motion. No fevers.
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions or allergies were not reported. On an unknown date, the patient was vaccinated with improperly stored GARDASIL 9 lot # N002720, expiration date 12-MAY-2019, third dose in series, one shot for prophylaxis (dose was not reported). The vaccine underwent a total of two separate excursions, but individual times and temperatures for each excursion were not available during the time of the initial call. The vaccine reached an "excursion high of 49.6 degrees" (however the reporter did not specify whether this was in Celsius or Fahrenheit). Between the two excursions, the vaccine was out of range for "a total of 40 hours and 22 minutes". The call was because of a data logger. No adverse effect was reported. No product quality complaint was involved. This is one of the two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA006396.
Patient states she received the flu vaccine at 9AM.  Around 12 Noon she began to feel nauseated, had diarrhea felt dizzy and had hot flashes.  She left work and went home.  By 4PM that day she was feeling much better.  Did not go see a doctor.
pt recvd vax & exp visual disturbance in the form of nystagmus; seen by opthalmology w/dx of ocular flutter by neurology w/dxs post-vaiccineal demyelinating problem; also has oscillopsia w/nystagmus; sore throat & nasal stuffiness;
On the 12th and 13th day after receiving the MMR, Client experienced fever (She didn't take her temperature),chils, sore throat and tiredness. These symptoms resolved with two days after they began.   She also experienced very tiny blisters-mostly single spots on leg stomach and foot.  She developed 2-3 spots together on her arm.  These blisters did not itch or open.  They resolved on their own and she did not see a doctor for them.
improperly stored MMRII was administered; This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapy was provided. On 05-OCT-2020, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) rHA, injection (lot # S022753, expiry date: 22-JUL-2021; dose, dose number, route of administration were not provided) for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent (STERILE DILUENT) (dose, lot number, expiry date and route of administration were not provided). Administered dose of vaccine experienced the temperature excursion of 50.5 degrees Fahrenheit for 168 hours. There were no previous excursions related. Data logger was involved.
17SEP91 grandmom called & reported PT was crying & PT's lt arm was swollen, but PT did not have a fever; grandmom took PT to MD; dx: cellulitis of lt arm & an ear infection;
Right eye shut side of face swelled.  No other swelling anywhere else.  No rash, no muscle weakness. Tingling on face.  4 hours post injection.
patient was supposed to receive an HPV vaccine but they received an Adacel vaccine that was not ordered for her with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from the other health care professional (nurse) via Medical Information (Reference number- 00736518) and transmitted to Sanofi on 23-Aug-2021.  This case involves a 28-year-old female patient who was supposed to receive an HPV (Human papillomavirus) VACCINE but they received an HPV VACCINE and DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] vaccine that was not ordered for her (wrong product administered).  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Information of concomitant medications was not reported.  On 19-Aug-2021, the patient received a dose (0.5ml) of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot number: U6927AA; expiry date: 280Aug-2023) via intramuscular route in the left deltoid for prophylactic vaccination instead of suspect HPV VACCINE not produced by Sanofi Pasteur (lot number and expiry date: not reported) via unknown route in unknown administration site for prophylactic vaccination.  It was case of actual medication error due to wrong vaccine administered (latency: same day).  It was reported, "Nurse needs some safety information as ADACEL was administered to a patient that shouldn't have received it she states. The nurse states that the patient was supposed to receive an HPV vaccine but they received an Adacel vaccine that was not ordered for her."  No adverse event was reported at the time of this report.  The outcome of the event was reported as unknown.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Information has been received from a physician concerning two 4 year old patients, siblings, who in January 2012, were vaccinated with a first dose of VARIVAX (Merck) (lot# not reported). The patients were both recently diagnosed with chicken pox after their first dose of VARIVAX (Merck). The patients visited physician's office. At the time of the report, the patients' outcomes were unknown. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available. Follow up information was received from a other health professional reporting that the 4 years old female with a history of being preemie, no illness at the time of vaccination and no adverse events following prior vaccination, on 31-FEB-2012 (previously reported as January 2012) was vaccinated on the right thigh with the first dose of VARIVAX (merck) (lot number 671029/1065AA, Exp. Date 05-JUL-2013) (dose not reported). No other co-suspects were reported. Concomitant vaccines administered on 03-FEB-2012, included second dose of MMR II (lot number 0152AA), second dose of VAQTA on left thigh (lot number 672221/1586AA) and first dose of KINRIX (lot number AC20B154AA) administered on left thigh. It was stated that on 17-JUN-2012, the patient experienced maculopapular rash on hands with fluid filled lesions clustered in groups, the patient was diagnosed with varicella. No treatment information was reported. The patient recovered with no residual effects after 3 weeks on approximately 08-JUL-2012. The relatedness for patient was diagnosed with varicella was unknown for VARIVAX (Merck). This is one of several reports from the same source. Additional information is not expected.
I had a cough, sore throat, body aches, nausea, headache, fever, left ear was plugged up, and slight stuffy nose. I tested positive for COVID-19 at the place I worked at. I took TYLENOL, ibuprofen, and liquid cold medicine.
acute varicella 11 days post inj;site w/+ 6cm local rxn; symptomatic tx;
Patient received her covid vaccine on 12/28/2020 in her left arm. Three days after vaccination she had pain and swelling in her right arm. She was seen by a health care provider on 12/31/2020 and an ultrasound showed extensive deep venous thrombosis in the left arm. She was started on a blood thinner (eliquis).  She had blood tests done on 1/1/20 and this showed leukocytosis. She was found to have acute myeloid leukemia and admitted to our service for treatment. We do not have blood tests prior to 1/1/20 so it is unclear when her leukemia started. Her deep venous thrombosis could be related to her acute leukemia but I decided to report it due to the proximity to the time of her vaccine. Her arm pain and swelling improved after administration of the blood thinner. She is currently being treated for her leukemia.
Patient states that since the moment she got her vaccine, her arm hurt. She said today that she did not have any redness, swelling, or heat in the area where the vaccine was given. She says that her arm has been throbbing and has been applying a heating pad. I told her not to apply heat and that she should apply ice and take tylenol if needed. I called the protocol doc and he said since there was no redness or swelling that she needs to follow up with her primary care doctor. She met with Dr, her primary doc and he prescribed diclofenac and tizanidine. She she just had heart surgery, her cardiologist recommended that she not take either med. I called patient back to let her know that she should follow-up with her doctor if she is still having pain.
NauseaVomiting FEVER, CHILLS, DIZZINESS, BODY ACHES, WEAKNESS, FATIGUE.
Rash to right facial cheek; Rash to left arm at injection site; This is a spontaneous report from a contactable nurse, the patient. A 56-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP7534) via unspecified route of administration to arm left on 25Mar2021 03:00 (at the age of 56-year-old) as a single dose for COVID-19 immunisation. The patient medical history included hypothyroidism. The patient had known allergy to sulfa drugs. The patient concomitant medication included levothyroxine (MANUFACTURER UNKNOWN), liothyronine (MANUFACTURER UNKNOWN) both started since an unknown date for unknown indication. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 25Mar2021 at 21:00, the patient experienced rash to right facial cheek, rash to left arm at injection site. Treatment received for the adverse events was reported as no. The adverse event 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 facial rash and vaccination site rash was recovered on an unknown date in Mar2021.   No follow-up attempts are needed. No further information is expected.
Very Lethargic late in the night. Went to bed and had really bad chills, shakes, and ultimately night sweats. This lasted essentially through the night, into the late morning, and early afternoon. Started to fell normal late afternoon, 24-26 hours after the shot.
rashes in passing; This case was reported by a pharmacist via call center representative and described the occurrence of rash in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was recovered/resolved.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received Shingrix and had rashes. The reporter consented to follow up. The HCP did not had any additional information for these rashes and they might had been reported to GSK.  For tolerances of 2nd dose, refer case US2020AMR206766, reported by same reporter for same patient. This case linked with US2020205662, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020205662:same reporter US-GLAXOSMITHKLINE-US2020AMR206766:same patient (2nd dose)
Fatigue, chills, fever, painful axillary lymph nodes.  I needed pai. And fever medication for the symptoms.  I needed to sleep ALOT.  This shot RUINED my weekend.  Shot was friday, still sick Sunday.  Very bad, I wouldn't recommend this to anyone.  It's not worth it!
Information has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. The patients' medical history and concurrent conditions were not reported. Concomitant therapies included sterile diluent (manufacturer unknown). On 01-SEP-2017, the patients were vaccinated with improperly stored VARIVAX (dose, frequency and route were unknown, lot # M049127, expiration date: 15-DEC-2018, lot # N010107, expiration date: 28-MAR-2019) for prophylaxis. Administered vaccine experienced the temperature excursion of -14 Celsius degree to -10 Celsius degree (-14.2 Celsius degree) for 6 hours. There was no previous temperature excursion. Data logger was involved. No adverse effects reported. No product quality complaint (PQC) was involved. This is one of several reports from the same reporter. All telephone attempts on 10-OCT-2017 to obtain follow up information have been unsuccessful. Follow up information has been received from an other reporter concerning a 12 month old patient. On 10-OCT-2017, the patient vaccinated with improperly stored VARIVAX (dose, frequency and route were unknown, lot # N008077, expiration date: 09-MAR-2019) for prophylaxis. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1709USA002098: US-009507513-1709USA002186.
Pt's thigh felt hot & was red shortly p/inject; @ 1030PM parents noted pt felt warm; @ 1:30AM pt had sz; p/sz quit breathing 10-15secs & was limp; had another sz; eyes rolled back, fists clenched, shook all over; had 3rd sz; to ER; t101 R;
patient got lightheaded, dizzy, vomited.  Had pt sit with a cold pack for 30 minutes and then was back to normal
Chills, Muscle Aches, Weakness, Nausea and Headache
Breakthrough case. Had vaccine on 04/10/2022. Was around someone who had COVID-19 then 2 days later on 05/19/2022, I started feeling tired and feverish. I tested negative on my home test. Then I went to a clinic the next day and I tested positive. Dr. said symptoms wasn't severe enough so he didn't prescribe anything. Had COVID- 19 for 6 days. Currently, still having a dry cough.
The second one flared up my neuropathy badly; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program, Pfizer . A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunisation. Medical history included neuropathy. The patient's concomitant medications were not reported. The patient previously took the first dose of BNT162B2 on an unspecified date for COVID-19 immunisation. On an unspecified date, the patient experienced the second one flared up my neuropathy badly. It was also reported by the patient that was having lots of pain and barely able to walk. The outcome of the event was unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Felt feverish and achy the next day and continue to feel achy, occassional sore, cough up flem and have waves of nausea.
This spontaneous report was received from registered nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not reported. On 17-MAR-2017, the patient was inadvertently vaccinated with an expired dose of M-M-R II (dose, route and anatomical location were not reported) (lot # L008684 and expiration date 13-MAR-2017) for prophylaxis. Additionally, a dose of sterile diluent (manufacturer unknown) was administered (dose, route, lot # and expiration date were not reported). No adverse effects were reported. Additional information has been requested.
Local inflammatory response throughout entire left  upper arm, loss of 2 duty days, resolving.
8PM 22APR97 pt had rattle, congestion, upper resp system;fever of 104 R;pt cont to worsen through 23APR97 w/resp distress noted d/t congested nasal passages;mom lt thigh area swollen from groin to knee & red;to MD 25APR97 w/ear infect
loss of appetite; "just like having COVID-19 infection"; laid in bed; Chlls; body aches; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (loss of appetite), CHILLS (Chlls), MYALGIA (body aches), FEELING ABNORMAL ("just like having COVID-19 infection") and ASTHENIA (laid in bed) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Thyroid disorder. Concurrent medical conditions included Hypertension and High cholesterol. Concomitant products included LISINOPRIL for an unknown indication.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced DECREASED APPETITE (loss of appetite), MYALGIA (body aches), FEELING ABNORMAL ("just like having COVID-19 infection") and ASTHENIA (laid in bed). On an unknown date, the patient experienced CHILLS (Chlls). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DECREASED APPETITE (loss of appetite), CHILLS (Chlls), MYALGIA (body aches), FEELING ABNORMAL ("just like having COVID-19 infection") and ASTHENIA (laid in bed) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.