chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt was brought to the triage area with c/o chest tightness, weakness, and mild SOB. No CP, non-radiating. VS taken: (1:47 PM) BP 141/97, HR 108, Resp 20, O2 sat 100 on R; (1:52 PM) BP 147/98, HR 106, Resp 18, O2 sat 100% on RA. Pt no in apparent distress, speaks in full sentences, mentating well. Nurse manager and attending MD at triage area to monitor pt. Advised pt to go to ED but pt refused. Pt stated that he will be fine and just need to go home and rest. ED precautions discussed. Pt verbalized understanding and signed AMA form. Pt left the triage area with no assistance, ambulating well, with steady gait.
Patient states she received the Moderna second vaccine around noon.  Around 2 am she sent and drank some warm milk.  As she walked up the stairs, she felt like vomiting and also felt like she could not move.  Tried to crawl to the bathroom when she passed out.  woke up with clothes full of vomit.  Feeling better today.
Site where DTaP given has large area of redness around injection site. Area is the size of an orange. Area hot to touch. Pt. has no pain or fever.
Developed eczematous rash, 1 day, post vax, on face (between eyebrow and back of neck) Seen 1/14/2000, rash spread to perioral area and trunk. On 1/15/2000, whole face is red, dry, chapped, eyes swollen, rash all over. Started on Prelone po. Rash resolved 1 day after given Prelone.
Information has been received from a physician concerning a "9 year old" female who was vaccinated SC with a second dose of varicella virus vaccine live (Oka/Merck). Subsequently "eight hours post vaccination" the patient experienced a local injection site reaction that was hard, swollen, red and feverish to the touch." The reaction had been of "softball-size." Medical attention was sought. The patient recovered. No product quality complaint was involved. Additional information has been requested.
Case number PHHY2011US63531 is an initial spontaneous report received from a physician on 14 Jul 2011. This report refers to a 2 year old boy. He was vaccinated with MENVEO (batch number: X1028) intramuscularly on 14 Jul 2011. But, the patient received only Men CYW-135 liquid conjugate without reconstituting it with Men A lyophilized powder conjugate. No adverse event was reported following this drug administration error.
Patient reported hives/itching two hours after administration. She had the same FLUVIRIN MDV administered the year prior without reaction. She took BENADRYL which provided relief. Patient noticed hives the next morning as well as took more BENADRYL. She stated she will seek treatment if it continues.
Got his first Moderna dose in June. He was unable to get scheduled for second vaccine dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Got his first Moderna dose in June. He was unable to get scheduled for second vaccine dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In June 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Aug-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Got his first Moderna dose in June. He was unable to get scheduled for second vaccine dose). On 24-Aug-2021, PRODUCT DOSE OMISSION ISSUE (Got his first Moderna dose in June. He was unable to get scheduled for second vaccine dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was Not applicable.       Concomitant product use was not provided. Treatment information was not provided.
Consent form completed stating client had not received any COVID vaccines. 1st Moderna dose was administered. When entering the vaccine information into system it was discovered that the client had already received one dose of Pfizer on January 2, 2021. At this time no adverse reactions have been reported. The nursing home that the resident lives at was immediately notified.
3/31/22 6pm - projectile vomiting and dizziness but was able to sleep at night - couldn't walk without holding onto furniture, etc. 4/1/22 all day - dizziness, nausea but no vomiting - remained in bed mostly - still had trouble with balance issues 4/2/22 My first attack of Acute Vertigo  - not good! - Remained in bed with head raised on 2 pillows which helped 4/11/22 Saw my Primary Physician.  I struggled with dizziness until this date. 4/14/22 Saw Dr., for followup - referred for Brain MRI & started PT for Balance/Dizziness Issues 4/20/22 Had Brain MRI - showed only a Lesion on the R side behind my jaw - referred to ENT 5/2022 Saw Dr. - ordered an UltraSound Guided Fine Needle Aspiration 6/9/22 Fine Needle Aspiration done - we'll watch this - Ultrasound scheduled for 9/23/22
Local adverse reactions on arm i.e. swelling at injection site, red spots, feverish in arm, patient better in 3-4 days.
dizziness; This is a spontaneous report received from a contactable Nurse (daughter). Follow up (04Feb2021): This is a follow up spontaneous report from a contactable Nurse was processed together along with initial information.   A 75-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, batch/lot number and Expiration date was not reported), via an unspecified route of administration, on 25Jan2021 (at the age of 75 years), as a single dose for covid-19 immunisation. The patient medical history included blood pressure, kidney stones. Concomitant medications were unknown (Nurse stated, "Not that I know of, he is taking allergy medicine, I think ."). On an unknown date (a day or two after vaccination) in Jan2021, the patient had experienced dizziness ever since he got it, he is able to drive but caller is concerned (he is 75 years old male). He has been continuing dizzy from nine days. Caller wanted to know about dizziness and how long it lasts. The patient was kind of ignored and did not had any treatment. Outcome of the event was reported as not recovered. The causality was reported as the nurse stated, "It is just said like maybe it is caused with vaccine. He is 75 years old and I don't know, it could be his heart, I don't know (not clarified). The dizziness, when I look it at on Pfizer, it says that there may be like a severe reaction and that will be within 24 to 48 hours, and he is still experiencing."  Information on the lot/batch number has been requested.  Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Received 1st dose in11-24-2018, no record of receiving 2nd; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 24 November 2018).   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: 19-OCT-2022 Reporter's Comment: The reporter reported that the patient received first dose of Shingrix vaccine and not had record of receiving the 2nd dose. The reporter wanted to know whether should start over the series. Additional supportive information: Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination. The reporter requested to consent to follow up.
1st dose of Moderna symtoms were fever, hives, soreness at injection site from shoulder to elbow. Migrains bothered by bright light and noise. Nausea, muscle and joint pain, fatigue and raised blood sugars.   2nd dose soreness from shoulder to elbow, migrain, fatigue, muscle and joint pain, nausea. The following week continue to have muscle and joint pain but also have numbness on left side of body mostly from hip area down the leg to foot.  Both times unable to sleep causing insomia and restless sleep
This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), PYREXIA (fever), HEADACHE (headache) and MYALGIA (body aches) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A and 026L20A) for COVID-19 vaccination. The patient's past medical history included Anxiety in 1999, Depression in 1999 and Clot blood (Blood clot history (DVT+PE's)) in October 2003. Concurrent medical conditions included Fruit allergy (Kiwi), Latex allergy, Drug allergy (Morphine), Asthma since October 2003, Fruit allergy (Mango), Food allergy (Bell papers), Allergy to antibiotic (Erythromycin) and Contrast media allergy (CT contrast dye). Concomitant products included VORTIOXETINE HYDROBROMIDE (TRINTELLIX) for Anxiety and Depression, MONTELUKAST SODIUM (SINGULAIR) and FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) for Asthma, WARFARIN for Thrombus, PROBIOTICS NOS for an unknown indication. On 05-Jan-2021 at 4:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021 at 4:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Feb-2021 at 8:30 PM, the patient experienced CHILLS (Chills), PYREXIA (fever), HEADACHE (headache) and MYALGIA (body aches). The patient was treated with PARACETAMOL (TYLENOL) on 03-Feb-2021 at an unspecified dose and frequency. On 05-Feb-2021, CHILLS (Chills), PYREXIA (fever), HEADACHE (headache) and MYALGIA (body aches) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Feb-2021, Body temperature: 101.9 (High) Fever of 101.9. Patient reported 4 weeks of heart bounding, racing, beating irratically medical history which was started on 03 DEC 2020 and it is ongoing. Protandim supplement is the concomitant product used for unknown condition started on Jan2014. Most recent FOLLOW-UP information incorporated above includes: On 09-Apr-2021: Follow up received 09apr2021, they provide 2nd dose information and patient medical history and concomitant drugs are provided.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Patient reported injection site/arm became very itchy, very red, very hot, and somewhat swollen the day following her injection, covering a large portion of her arm. I witnessed it the next day, when the patient stated that the reaction had calmed down somewhat, and it was still very red and covering a large portion of the arm.
Metallic taste in mouth more than a week; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 20Mar2021 at 12:00 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. On an unknown date in Mar2021, the patient experienced metallic taste in mouth more than a week. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19.The clinical outcome of the event metallic taste in mouth more than a week was unknown at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Missed second dose (past 36 days with no second dose); This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed second dose (past 36 days with no second dose)) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed second dose (past 36 days with no second dose)). On 26-Apr-2021, PRODUCT DOSE OMISSION ISSUE (Missed second dose (past 36 days with no second dose)) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.  No treatment information was reported.
tired; my face became flushed; This is a spontaneous report from a contactable consumer (patient). An 68-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 intramuscular, administered in arm left (upper) on 05Mar2021 12:30 (Batch/Lot Number: EN6208) (at the age of 68-year-old) as DOSE 2, SINGLE for COVID-19 immunisation. Medical history included back pain and blood cholesterol from an unknown date and unknown if ongoing. Concomitant medications included ibuprofen (ADVIL 12HOUR) taken for back pain from an unspecified start date and ongoing; atorvastatin taken for blood cholesterol, start and stop date were not reported; glucosamine chondroitin pm (GLUCOSAMINE CHONDROITIN PM); monascus purpureus (RED YEAST RICE); colecalciferol (VIT D3); fish oil; and ubidecarenone (COQ-10). Historical vaccine included BNT162B2 dose 1 intramuscular in the left upper arm, on 12Feb2021 12:30 (at 68 years of age) (lot/batch number-EM9809) for COVID-19 immunisation and experienced swelling of face and swollen eyes. The patient experienced her face became flushed on 05Mar2021 11:00 with outcome of recovered in Mar2021 and tired on 06Mar2021 with outcome of unknown. It was reported that after the second vaccine, the patient's face became flushed at 11 am and in the evening the same day as the vaccine. She immediately took a BENADRYL and was just tired the next day. Therapeutic measures were taken as a result of her face became flushed (flushing).  Follow-up attempts are completed. No further information is expected.
vitiligo rapidly spread everywhere/developed vitiligo skin condition; sore arm; look terrible; achy; chills; fever; I am in pain with burning skin most of the time; It is mentally, emotionally, and psychologically depressing; This spontaneous case was reported by a consumer and describes the occurrence of VITILIGO (vitiligo rapidly spread everywhere/developed vitiligo skin condition), PAIN IN EXTREMITY (sore arm), BURNING SENSATION (I am in pain with burning skin most of the time), DEPRESSION (It is mentally, emotionally, and psychologically depressing) and UNEVALUABLE EVENT (look terrible) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Vitiligo (20 plus year old vitiligo condition) since 2001.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced BURNING SENSATION (I am in pain with burning skin most of the time) and DEPRESSION (It is mentally, emotionally, and psychologically depressing). On an unknown date, the patient experienced VITILIGO (vitiligo rapidly spread everywhere/developed vitiligo skin condition), PAIN IN EXTREMITY (sore arm), UNEVALUABLE EVENT (look terrible), MYALGIA (achy), CHILLS (chills) and PYREXIA (fever). At the time of the report, VITILIGO (vitiligo rapidly spread everywhere/developed vitiligo skin condition), PAIN IN EXTREMITY (sore arm), BURNING SENSATION (I am in pain with burning skin most of the time), DEPRESSION (It is mentally, emotionally, and psychologically depressing), UNEVALUABLE EVENT (look terrible), MYALGIA (achy), CHILLS (chills) and PYREXIA (fever) outcome was unknown.            No concomitant medications were provided. No treatment medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 10-Aug-2021: Follow-up information received contains added events - Myalgia, Burning sensation, Depression, Pain, Chills, Pyrexia,  and Lot No. - 002A21A On 10-Aug-2021: Follow-up information received contains no new Information.
Towards Thursday afternoon I started experiencing a sore throat. About 3:00AM on Friday, I had a slight fever and a headache which awakened me. I took a COVID-19 home test and got a faint positive. The fever continued to about 100.0 I developed some fatigue and a yucky cough. I started to feel a little discomfort in my upper chest so I made an appointment and saw the doctor on that Saturday. I had a fever of 101.1, I had taken a 2nd test on Friday and it immediately was positive. I took a total of 3 test and all were positive. I was prescribed PAXLOVID and all my symptoms improved except for the cough. I still have coughs that produces phlegm 2 or 3 times an hour that I did not have prior to this. My fatigue subsided about 7 or 8 days ago.
Patient received shot while sitting down. She got up for husband to get shot. She started to feel a little faint, ringing in ear. She sat down immediately. She was sweaty and feeling a little out of it. Decided to call EMS when seeming to go unresponsive. Manager got AED but was not needed. Patient started to come to, had pulse and was breathing and talking. Ambulance came and took her away to run further diagnostics.
the patient received 3 additional doses of M-M-R II; the patient had a negative measles titer; This spontaneous report was received from a physician assistant concerning a 28-year-old female patient. The patient's pertinent medical history and concomitant therapies were reported as none. It was reported that the patient was allergic to unspecified penicillin.     The physician reported the patient received 3 doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II (strength, route of administration lot number and expiration date were not reported) on unspecified dates when the patient was growing up and the patient was moving on to be a healthcare provider at age 28 years. The physician assistant stated the patient had measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) titers drawn during a physical for her school that also had a negative measles titer on 01-APR-2019. On an unknown date, the patient received 3 additional doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and then subsequently continues to have a negative measles titer. The patient sought medical attention, she received treatment and had an IGG antibody blood test (results not provided).   The outcome of measles antibody negative was reported as not recovered.  The causality assessment between the event with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was not reported.
Fever, chills, body aches, cough, congestion, loss of appetite, fatigue
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. The patients were vaccinated with a dose of GARDASIL (lot number not specified). Route was unknown. The reporter stated that up to 10 patients had received improperly stored vaccines during the time period of 17-SEP-2012 through 02-OCT-2012. Vaccines involved were MMR II, VAQTA, RECOMBIVAX HB and GARDASIL. No symptoms were reported. This is one of multiple reports from the same source (other case IDs 1210USA009229, 1210USA009230 and 1210USA009231). Additional information has been requested.
10/6 at 18:00-queasy, vomit, then 3 times of diarrhea. 10/7-couple bouts of diarrhea, sore arm, trouble lifting because sore. Trouble sleeping.
Patient works third shift, so he sleeps during the day and went to bed after his first dose. He woke up about 4 hours after his first dose with a "chest spasm". He said it lasted about 30-40 minutes before it subsided. (He also experienced chills and sweating around the same time, which subsided after ~8-10 hours.)
Patient noticed a small red rash around the injection site on Wednesday morning 9/2/09 two days after shingles shot was given.  The rash was red and sore, and had a small degree of itching.  I observed the rash on Wednesday about 1130 am. I suggested that she call her primary care physician, & let him know & suggested Benadryl (but told her to call md either way).  After checking with patient today (Friday 9/3/9), the rash had improved significantly.
I am 5 days out from the 2nd dose. I had to make an urgent care visit because of shortness of breath, blurred vision, light headedness, brain fog, nausea, fatigue, feeling of fainting and tightness in throat. These symptoms have been present and overwhelming for over 3 days presented themselves after day 2 of vaccine. The original symptoms of headache, body aches and chills subsided by day 3.
mom reported pt cried for 3hrs & could not be consoled;OTC APAP did not help;no fever;went to ER;
pt recv vax 27JUL94 & 10AUG04 presented to ER w/pharyngitis, flu-like sx, sz; pt was hospitalized & dx w/encephalitis; pt was treated w/Dilantin; No further details were provided;
shingles in her scalp; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HERPES ZOSTER (shingles in her scalp) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced HERPES ZOSTER (shingles in her scalp). The patient was treated with VALACICLOVIR HYDROCHLORIDE (VALACYCLOVIR HCL) for Adverse event, at a dose of UNK dosage form. At the time of the report, HERPES ZOSTER (shingles in her scalp) outcome was unknown.            No concomitant medication were provided    Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: Follow received on 29-APR-2021 : Consumer declined Consent.
That evening of second vaccine tremendous pain in all my long bones.  I could not turn in my sleep without waking up I pain. Tooling Advil all night as directed on bottle. Had low grade fever 100.1  pain continued all weekend with decline in severity of bone pain. Bone pain currently in bilateral arms especially in forearms. Can function during day pain level 2/10 in day. In evening starting around 6:00 pm. I need to take my Advil and apply cold compress to my arms for relief of pain. Pain level at 6/10. I never in my life experienced this sort of pain. Even hard to describe it. I would not call it an ache. More like a burning pain.  If not under control after this coming weekend. I am seeking medical help
Rash developed on right arm from elbow to the injection mark on the morning of 10/5/23. In addition I had extreme dizziness which continued into he afternoon and evening.