chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Narrative: Patient received the following Moderna COVID vaccines at this facility: 3-29-21 and 4-27-21. Patient was hospitalized for COVID pneumonia on 3-4-22 and transferred out to another facility on 3-9-22.
Rash, pink 2x3 inches at site of injection. Not fluctuant. No fever. Present x 2 h
Hot flush within the first 15 minutes of the short.  Tiredness and lack of appetite for two days. The next day after the short experienced numbness and tingling to my left arm and fingers these symptoms stayed for two days.
Patient reports developing around the injection site, radiating to hand.  Says arm was warm to the touch with mild swelling. Also reports nausea.
Fatigue; Headache; chills fever; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old adult non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6207), via an unspecified route of administration in the left arm on 12Mar2021 at 10:15 (at the age of 35-years-old), as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included vyvanse (MANUFACTURER UNKNOWN), guanfacine (MANUFACTURER UNKNOWN), baclofen (MANUFACTURER UNKNOWN), vitamin d (MANUFACTURER UNKNOWN), NAC (MANUFACTURER UNKNOWN), all from unknown dates and for unknown indications. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not tested positive for COVID-19 since the vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 20Mar2021, at 19:00 (around day 8 after injection), the patient experienced fatigue, headache, chills fever, still persisting by the day of report. No therapeutic measures were taken as a result of the adverse events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event fatigue, headache, chills fever was not resolved. No follow-up attempts are possible. No further information is expected.
Beginning at 1:00am February 13, 2021 I begin to feel feverish with a temperature of 99.4.  I took the maximum dose of 3000 mg acetaminophen  every four hours with the last dose at 2:00pm.  My fever ranged from 99.4 to 100.8 during this period.  After the acetaminophen wore off in the afternoon, my temperature went to 102.8.  I took one dose 600mg of ibuprofen at 5:00pm and began to feel better throughout the evening and night.  Today I am very weak but recovering.
On 2/1, patient received Moderna as first dose then on 3/1 second dose was administered as Pfizer.  Patient did not have any immediate reactions or symptoms.
- BLOOD CLOT IN LUNG CAUSING A-FIB.  WENT TO WALK IN, IMMEDIATELY SENT TO THE EMERGENCY ROOM AND FROM THERE TO THE HOSPITAL. DIAGNOSIS - A-FIB W/ RAPID VENTRICULAR RESPONSE. SHORTNESS OF BREATH.  CURRENTLY ON APIXABAN, WAS ON ATORVASTATIN AND METOPROLOL UNTIL THIS WEEK.  ECHOCARDIOGRAM SCHEDULED JAN. 18TH TO DETERMINE ANY PERMANENT DAMAGE WITH VISIT TO CARDIOLOGIST ON JANUARY 28TH FOR CONSULTATION REGARDING RESULTS. APPOINTMENT AGAIN WITH DR. FOR LAB WORK ON BLOOD CONDITION RE-CONTINUING APIXABAN) AND AGAIN A CONSULTATION WITH MID-APRIL/MAY REGARDING PERMANENT DAMAGE AS A RESULT OF THIS VACCINE. WAS HEALTHY, ACTIVE 74 YEAR OLD UNTIL TWO WEEKS AFTER SECOND INJECTION.
After the second shot, earlier the next morning I received a severe pain in my neck, similar to a "crick" in my neck that has lasted more than two months now.   I need to know how to relieve the severe pain in my neck or what should I do about it.  Please call me as soon as possible and let me know what I should do about this pain.   The doctor prescribed Prednisone and Cyclobenzaprine but they have not  helped the pain.
This is a spontaneous case, initially received from other non-health professional on 14-Nov-2018, concerning a male patient of unspecified age. It was reported that, whenever the flu vaccine was withdrawn, the vaccine leaked out from the rubber stopper (explicitly coded as product leakage). As the secured lock was popped off the vial the rubber stopper was dented in and off a little (explicitly coded as product closure issue). It was reported that, when the nurses removed the hard cap and stuck the needle in the middle, there was a corner on the top where the rubber stopper was dented in causing a hole where the medication leaked. On 01-Oct-2018, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch  number: 252234 and expiry date: 30-Jun-2019] from leaked vial (explicitly coded as drug administration error). There were only 5 doses left out of the 10 doses in the vial. It was reported that sample vials were available in which they had one opened vial and 46 left. The package was not damaged, but the rubber stopper was damaged. From the withdrawal of first vaccine, the leakage was observed. The needle used was 25-guage needle and the syringe were 3 ml syringe. The user had added air to the vial from the syringe. At the time of this report, no adverse event was reported. This case was associated with product quality complaint, hence quality assurance investigation (QAI) had been requested and the corresponding product technical complaint (PTC) reference number was 1034101. Based on the investigation performed, it can be concluded that FLUCELVAX Batch 252234 was manufactured in compliance with the approved internal procedures and in accordance with the quality requirements. No internal root cause was identified in the manufacturing process. A follow-up revealed the complainant was adding air to the vial prior to extracting doses and was inverting the vial when withdrawing the needle from the stopper. It is known that the addition of air to the vial can over pressurize the vial and cause leaking. In addition, inverting the vial while trying to extract a dosage can increase the potential for the vial to leak. The root cause for this investigation was found to be User-Improper Handling (explicitly coded as wrong technique in product usage process). The reporter assessed the case as non-serious. Follow up report received from QA department on 19-Nov-2018: The QA investigation report stated that, the root cause for the leaking FLUCELVAX MDV of Batch 252234 was due to user or improper handling. Added new event (wrong technique in product usage process) in event tab. The narrative was amended accordingly.
Rash from ankles to neck.  Still have rash 6 days after 2nd shot.
Pt called pharmacy morning of 12/21/17 to report adverse events to PNEUMOVAX 23 givien on 12/20/17. She stated that event began approximately 2 hours after vaccine was given. First S&S were pain, swelling, redness and hot to touch at injection site, followed soon after by dizziness and light nausea. Pt reports additional symptoms of tightness in neck, more severe nausea and swelling of entire left arm from elbow to shoulder with onset in late evening and early morning. No report of facial or neck swelling, no rash. Pt refused need to see doctor at the time. Advised pt to monitor, use NSAID or choice for pain and use diphenhydramine OTC for the next 48 hours. Also advised that pt should seek urgent / emergency medical care if S&S get worse or swelling begins to effect neck / mouth / throat area.
started to notice itchy patches and hives that would travel  all over my body, hands and feet especially. Itchy scalp and hot ears. Still experiencing everyday.
4/9/21 redness around vaccine area ,sore swollen and muscle feels hard ,also itchy
1257 as patient drove off from vaccine bay, mom reports he?s started fainting and she pulled over so he would not crash. As we arrived to the vehicleA patient was Faint and lethargic but responsive. Patient mom reports patient always faints whenever he gets a shot. 1:01 911 called 1:02 Dr. arrived, blood pressure 121 systolic 1:06 fire Dept. arrived blood pressure 126/78 , 99%  on room air 12 lead  normal sinus rhythm. Patient and his parents feel going to the hospital will cause more anxiety.   1:28 patient went home wiener his parents. Mom driving his car      1:26
mom reports inj site swollen, very sore, entire body hurts, almost passed out, t99.9, extreme fatigue;
Warm  touch at the injection site; Sore at the site of injection; Red knot at the site of injection; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE WARMTH (Warm  touch at the injection site), VACCINATION SITE PAIN (Sore at the site of injection) and VACCINATION SITE ERYTHEMA (Red knot at the site of injection) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 30-Dec-2020, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Warm  touch at the injection site), VACCINATION SITE PAIN (Sore at the site of injection) and VACCINATION SITE ERYTHEMA (Red knot at the site of injection). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (Warm  touch at the injection site), VACCINATION SITE PAIN (Sore at the site of injection) and VACCINATION SITE ERYTHEMA (Red knot at the site of injection) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment for the event included cetirizine and symptoms subsided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Headache, diffuse aching, general malaise; 3" x 3" bruise at injection site.
LEFT AXILLA, CLAVICLE AND SHOULDER PAIN-NO REDNESS OR WARMTH AT THE INJECTION SITE
At 1:30am I woke up with rigors, temp of 101. Took some Tylenol and was able to fall back asleep. At 7:30am I woke up with rigors again, temp 100.1. Took Tylenol. Also have a terrible headache, pain 7/10, and fatigue
As soon as I wake up until I go to bed, ringing in ears/head & headaches. The only thing that helps is background noise and tylenol for the headache.
Bilateral Tinnitus. Woke up with it the day after my booster. It's been constant ever since.
Headache, tired, body aches almost immediately. Flushed cheeks and one degree fever about 3 hours later. Lymph node in left arm pit starts swelling that night. 8/24, 1 day after, symptoms continue. Diarrea begins 1:30am morning of 8/25/22. Lymph node in armpit swollen to size of golf ball. This has happened for all 3 Pfizer Covid vaccines he's had.
Headache, Myalgia, Arthralgia, Fever, SkinRash, Rash, ErythemaMultiform, UrticariaPruritus, Diarrhea inj site redness, itchy, swelling, pain; chills, runny nose Narrative:
About an hour post injection my arm became sore (remained sore for 4 days). The following day about 20 hours post injection I felt chills and tiredness. About 25 hours post injection I felt extreme fatigue and my whole body ached (this lasted for about 1 day). On day 3 post injection, I had a headache with nausea and motion sickness. Day 4 and beyond I have felt fine, no more symptoms of any sort. Chills were not treated. Body aches and headache were treated with ibuprofen and sleep.
Case number PHEH2014US015362, is an initial spontaneous report from a nurse received on 29 Jul 2014 and with a follow up information received from the nurse on 05 Sep 2014. This report refers to an 11-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. She was administered only MenCYW-135 liquid component of MENVEO (batch number: X13058) without being reconstituted with MenA, intramuscularly in the left deltoid on 29 Jul 2014 at 11.01. No adverse event was reported following the administration error (inappropriate preparation of medication). She was also vaccinated with MenA powder component on MENVEO (batch number: M13058) reconstituted with sterile water instead of Men-CYW-135, intramuscularly in the left deltoid on 30 Jul 2014 at 10.30 (See related case number: PHEH2014US015521). Follow up information received from the nurse on 05 Sep 2014: Updated site of vaccination and time of vaccination. Men A vaccination details were updated only in the narrative.
Pt in the past has had previous reaction to neomycin as extreme fatigue, but did not think it even was a possible allergy. With this flu shot patient experienced eye swelling, nose swelling, & difficulty breathing & fatigue 40 minutes after receiving the shot. Pt took 4 BENADRYL to stop reaction for several days. Swelling/difficulty breathing resolved in one day. Fatigue resolved in one week.
guillain barre syndrome; SQ; This spontaneous report was received from a pharmacist via Agency and refers to friend, a 42-year-old, female patient. Her medical history, concurrent conditions, concomitant medications, laboratory tests, previous drug reactions or allergies were unknown.  On an unspecified date in 2021, reported as a couple weeks ago, the patient was vaccinated with the first hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) injection, subcutaneously (SQ) (strength and anatomical location were not reported; dose, lot # and expiration date were unknown) for human papillomavirus (HPV) prevention (incorrect route of product administration).  On an unknown date in approximately 2021, she developed Guillain Barre syndrome which required hospitalization. The patient has been still in the hospital as of the time of this report. The reporter was unable to provide any additional details. It was unknown, if the patient received any treatment for the event. No cancer, congenital anomaly, or overdose were involved. The outcome of guillain-barre syndrome was unknown. The reporter did not assess the causality between the suspect vaccination and the event.  Upon internal review, the event Guillain-Barre syndrome was determined to be medically significant.
She mentioned that she has had a fever on and off, joint pain, and headaches; She mentioned that she has had a fever on and off, joint pain, and headaches; She mentioned that she has had a fever on and off, joint pain, and headaches; This is a spontaneous report from a contactable consumer (patient). A 71-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Unknown), via an unspecified route of administration on 2021(3 weeks ago from reported date), as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was due for her second dose, but mentioned that she has not been well for 8 days and told to rescheduled her second dose for Saturday. On 2021, the patient had a fever on and off, joint pain, and headaches. The patient had a fever of 102 degree Fahrenheit. Patient enquired if these side effects could possibly appear 3 weeks out after receiving the 1st dose. She asked if she could receive the vaccine while sick, and if not will she still be fine receiving the 2nd dose even later than Saturday as she does not feel safe doing so. She has yet to get in touch with her health care provider as of calling. Outcome of the events was unknown.  Information on Lot/Batch number has been requested.
Itching at injection site, soreness at injection site for over one week. Tired and joint pain, itching began to get worse in the next 3 days and moved to my back, legs and soles of my feet. The second week I went to my dermatologist for exam and began taking Zyrtec for allergies which alleviated the symptoms after 5 days.
Patient is 30 y female who was 11 weeks pregnant with a singleton gestation EDC 8/10/2021. She received the first dose of Moderna vaccine on 1/14/2021. Over the ensuing 4 days, she experienced fevers to 99.3 F, a bumpy red rash accompanied by itching at the shot site, nausea, headache, and fatigue. Tylenol 500 mg/dose was used for temperature control. She then had two days of minimal symptoms, but on 1/21 experienced sudden swelling of her left arm at the shot site with rapid expansion of the rash. The rash was itchy and the arm was painful. She had a significant headache, fatigue, and temperature to 99.3 F.  These symptoms worsened over the next two days, with temperatures reaching 100 degrees F, continued headache, fatigue, and increased arm swelling.  On 1/23/2021 the arm began to improve, but fevers to 99.3, fatigue and headaches continued.  The rash had expanded to almost 12 cm x 6 cm. Tylenol 500 mg dosing was used for symptom control with some improvement.  By 1/26/2021 the rash had mostly disappeared, the headache was gone, fevers were gone, and the fatigue remained. In all, symptoms lasted 12 days post-vaccination.
Itching to hands, feet, ears. "Tight" feeling to skin of face.  Given Zyrtec and solumedrol
Was having hives so I gave 25 mg  IM Benadryl. waited additional 15 min. Was insistant on driving self home. Benadryl  Lot #: 080012
2nd dose less than 28 days; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose less than 28 days) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Aug-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose less than 28 days). On 28-Aug-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose less than 28 days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported. No treatment drug details was reported.   Most recent FOLLOW-UP information incorporated above includes: On 01-Sep-2021: Follow up received on 01-SEP-2021. No new information
A father brought his 1-year-old daughter in for a flu shot to the health dept. Through the interpreter, it was determined this was a booster shot and father assured us it had been at least 30 days since original shot. The father had given the birth date as one date and the correct date was 4 month earlier. Other countries use this way of writing dates. This was a third flu shot the child was given this year.
high fever (over 102 & @ one point over 103) & flu sx (muscle aches, chills, lethargy, nausea) for a period of 5 days;
Patient was given the Covid 19 Pfizer shot. Per protocol she was in the waiting room for the 15 minutes but was not feeling well. Conscious but was feeling light headed and dizzy. Came over and mentioned about her condition and wanted her vitals to be checked, brought her back to the immunization room and took her blood pressure was around 140/90 was high and requested me to call 911. Had an intern stay in the room with her had the EMT take a look and they brought her to the ER. At the hospital she felt more dizzy light headed and weak and started noticing tinglyness and tightening of the throat at that time they started her on prednisolone and Benadryl, after which she started feeling better and normal. Had her under observation till 5 pm and let her go home. Did prescribe her to take Benadryl for the next two days. Was not able to contact her yesterday. But did speak to her to find out about her condition, which she is feeling much better. She did notice similar symptoms in the morning so she did take Benadryl. Did contact her doctor listed on VAR form and updated them. The ER also requested the patient to contact the CDC for further information.
Patient received vaccine at pharmacy, but talked to me about his reaction here at another pharmacy. So, I don't have access to all info (including Lot # or expiration). The patient stated that his arm was sore for 3 days after the vaccine, which is typical. But, then he said he was fine for 3-4 days before muscle aches, shortness of breath, and fatigue began. He also stated that he started metformin at the same time as the vaccine. He has continued metformin for 6 weeks. I told the patient that I would submit the VAERS form--just in case, but it is very possible that these effects are the result of the metformin. The patient was instructed to inform his prescriber about this reaction, and he assured me he would contact his doctor.
Mom states changing diaper when childs eyes rolled back into her head and she stared shaking. Then child was very lethargic and just blankly staring. Was admitted to Hospital.
After receiving my first COVID shot on 4/5/21, I did not have my monthly menstrual cycle which was due around 4/27/21. I had my second COVID shot on 5/4/21. On 5/28/21, I started my menstrual (on time after skipping a month), but it has been exceedingly heavy and long-lasting. This has been my worst in 38 years in regards to heavy bleeding. I didn?t have any cramps though, so that was a plus, but to be at the tail end of day SEVEN and still using ultra tampons every two hours is unprecedented in my personal biology. That is usually on only day two and maybe three, and those last at least four hours. Coincidence? Maybe? Just doesn?t seem right to me.
Nodule at injection site; Bruising at injection site; nodule is itchy; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site nodule in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 08-MAR-2023, the patient received the 1st dose of Shingrix. In MAR-2023, less than 2 weeks after receiving Shingrix, the patient experienced injection site nodule (Verbatim: Nodule at injection site), injection site bruising (Verbatim: Bruising at injection site) and injection site itching (Verbatim: nodule is itchy). The outcome of the injection site nodule, injection site bruising and injection site itching were not recovered/not resolved.   It was unknown if the reporter considered the injection site nodule, injection site bruising and injection site itching to be related to Shingrix.     It was unknown if the company considered the injection site nodule, injection site bruising and injection site itching to be related to Shingrix.   Additional Information: GSK receipt date 21 Mar 2023 The reporter was patient.  The reporter stated that receiving first dose of Shingrix, in the right arm. The reporter noticed nodule at injection site approximately one week ago. The nodule was itchy.  The reported there was also bruising at the injection site. The reporter consented to follow up.
Received 2nd dose of varicella vaccine on 4/01/05. On 4/02/05 had fever (101.5)and developed red, raised pimple-like rash w/scattered lesions on body about 20-30 total.