chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a 61 year old female patient, who was reporting on herself. The patient's medical history included migraines and four previous cases of shingles (unknown dates), prior to the patient ever being vaccinated with ZOSTAVAX. The patient also had unspecified food allergies. In August 2016, the patient was vaccinated with ZOSTAVAX injection, via subcutaneous route (dose, route and site of administration, lot number and expiration date were not reported) for prevention of shingles. Concomitant therapies included metoprolol. On 24-MAY-2017, reported as 2 days ago, the patient developed shingles. When the patient realized that she had shingles, she sought medical attention with a physician assistant. In response to the patient's outbreak of shingles, the physician assistant prescribed valacyclovir hydrochloride to treat the adverse event. No laboratory diagnostics studies were performed and there was no product quality complaint involved. At the time of the report, the patient did not recover from shingles. The relatedness between shingles and ZOSTAVAX was not reported. Additional information has been requested.
Some chest soreness on left side around 1:15 p.m. and 4:15 p.m. on 2/23/2022 and vertigo at 10:00 a.m. on 2/25 and chest soreness at 3:10 p.m. on 2/25/2022
Initial report was received 06 April 2012 from another manufacturer (Service Request Number: 1-5049831690), who received the report from the patient's parent. A woman (age and date of birth not reported) received a "DPT" vaccine when she was a small child (manufacturer unknown; lot number, route, site and date of administration not reported), and an unspecified amount of time later, she experienced paralysis for 10 hours. The reporter stated, "they then removed the P part of the vaccine. After that, she was given half shots of vaccines and still broke out with measles, etc. The Measles shots and the rest were all given in single doses back then". No additional information was provided at the time of the report. The reporter for this case is the same as for case number 2012-03773. Documents held by sender: None.
acting strange behavior wise; thought process not being the same; Not acting normal; Giggling inappropriately; A spontaneous report was received from a Other Health Professional concerning a 34-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273)  experienced acting strange behavior wise, thought process not being the same, not acting normal, giggling inappropriately.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 05-JAN-2021 prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection.    On 06-JAN-2021, the patient's experienced acting strange behavior wise, thought process not being the same, not acting normal, giggling inappropriately.  Treatment medications were not reported.  Action taken with mRNA-1273 in response to the events was not reported.    The outcome of the events was considered as unknown.; Reporter's Comments: Very limited information regarding these events has been provided at this time.  Further information has been requested.
I had a sudden unexpected heart attach caused by a blood clot in left atrial descending (LAD).  I cannot say for certain the event was related to the vaccine but I had been otherwise healthy.
Starting 48 hours after injection,Extreme fatigue, cold chills,Loss of appetite, nausea, weakness, moderate to severe muscle aches, especially upper and lower back and rib area. Only slight fever of 99.8 F. This lasted for Approximately 4 days. Now I have recovered.
Sore arm has persisted since 3/12/2021.  Cannot do usual activities without pain (lift arm, sleep on left side, reach for toilet paper, change clothes, and cannot do many of my usual yoga postures).  At the time of injection, the shot hurt more than usual flu shots.
severe diarrhea; fever; lethargy; This is a spontaneous report from a contactable consumer (patient). A 75-year-old non pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Batch/Lot Number: not provided) via an unspecified route of administration in right arm on 22Oct2021 12:00 (age at vaccination 75 years) as single dose for covid-19 immunisation. The patient was not pregnant at the time of vaccination Medical history and concomitant medications were not reported. The patient had no known allergy. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No List of any other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19 and not tested for COVID-19 since vaccination. The patient experienced severe diarrhea, fever and lethargy on 23Oct2021 07:00. The patient was not received any treatment for the events. The clinical outcome of the events was not recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
53 y/o female with no past medical history who presents with nausea and mild dizziness post vaccination. Patient states that this is her second vaccine in the two-dose series. Patient states that she received todays vaccination to the Left arm. Patient also states that she experienced the same symptoms with the first vaccination to include vomiting and chills lasting a few days. Patient denies headache, vision changes, sore throat, difficulty swallowing, difficulty breathing, shortness of breath or chest pain. NP and Paramedics at patient side. Patient initial vitals, 150/98 BP, 69 HR, 100% RA, 12 Resp. Patient dry heaved for approximately 20 mins with resolution post. Patient stated that symptoms resolved and that she was comfortable being sent home. Patient vital reassessed, 136/90 BP, 68 HR, 99% O2 and 12 Resp. Patient discharged in stable condition, patient ambulated without difficulty.
daily headaches which happen multiple times day and night; vivid dreams; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 08Oct2023 at 15:00 as dose 1, single (Lot number: HH7595) at the age of 70 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "bronchial asthma when ill with a cold" (unspecified if ongoing), notes: bronchial asthma when ill with a cold; "bronchial asthma when ill with a cold" (unspecified if ongoing), notes: bronchial asthma when ill with a cold; "Latex allergy" (unspecified if ongoing). Concomitant medication(s) included: FLU, on 01Sep2023 as dose number unknown, single; RSV VACCINE, on 01Sep2023 as dose number unknown, single. Past drug history included: Vicodin, reaction(s): "Drug allergy"; Floxin, reaction(s): "Drug allergy". Vaccination history included: Moderna (had Moderna in the past with no side effects), for COVID-19 immunization. The following information was reported: HEADACHE (non-serious) with onset 15Oct2023, outcome "not recovered", described as "daily headaches which happen multiple times day and night"; ABNORMAL DREAMS (non-serious) with onset 15Oct2023, outcome "not recovered", described as "vivid dreams". Therapeutic measures were not taken as a result of headache, abnormal dreams. Additional information: Patient stated "I have been getting daily headaches which happen multiple times day and night as well as vivid dreams, these all started about a week after the Covid vaccine. I had Moderna in the past with no side vaccine."
Headache, chills, feeling like entire body was on fire.  Arm at injection site swollen, hard and red.  Redness is a very large area across width of arm.
Irritability, anxious, body aches, increased perspiration, headache, sore arm.
Headache, chills/fever, sore throat, intense body aches, swollen arm/underarm, dizziness, sweats
Patient has not reported any AE; inadvertently administered the 2nd dose of the Moderna vaccine which was beyond the BUD to a patient; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (inadvertently administered the 2nd dose of the Moderna vaccine which was beyond the BUD to a patient) and NO ADVERSE EVENT (Patient has not reported any AE) in a 74-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 015B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Feb-2023, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 10-Feb-2023,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (inadvertently administered the 2nd dose of the Moderna vaccine which was beyond the BUD to a patient). On an unknown date, the patient experienced NO ADVERSE EVENT (Patient has not reported any AE). At the time of the report, EXPIRED PRODUCT ADMINISTERED (inadvertently administered the 2nd dose of the Moderna vaccine which was beyond the BUD to a patient) and NO ADVERSE EVENT (Patient has not reported any AE) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (Patient has not reported any AE) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (inadvertently administered the 2nd dose of the Moderna vaccine which was beyond the BUD to a patient).    No concomitant medications were provided. The vaccine was initially stored in the refrigerator on 26-Oct-2022.  No treatment medications were provided.
Immediately following a Moderna vaccination, the patient starting feeling tingling in her feet and hands.  Her legs became heavy followed by stiffness in her legs and arms.  Her eyes were wide open and she became unresponsive to our questions.  Patient's breathing shallowed and was given one dose of an Epi-Pen.  The patient immediately responded and she could again control her eyes and was talking.  The patient slowly started to stiffen up,  losing control of her eye movement and her breathing was once again shallow with her lips becoming bluish in color.   We administered a second Epi-Pen and the patient responded for about three minutes when the paramedics arrived.
vomiting yellow liquid; Severe chills; headache; patient received a third/booster dose; patient received a third/booster dose; This is a spontaneous report from a contactable consumer (patient). A 62-years-old non-pregnant female patient received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EN6204) via an unspecified route of administration, administered in arm right on 01Oct2021 as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation. Medical history included cancer from an unknown date and unknown if ongoing. The patient previously received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EF6455) via an unspecified route of administration, administered in arm right on 24Mar2021 as DOSE 2, SINGLE for COVID-19 immunisation. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: FC3184) via an unspecified route of administration, administered in arm right on 05Mar2021 as DOSE 1, SINGLE for COVID-19 immunisation. The patient's concomitant medications were not reported. Facility where the most recent COVID-19 vaccine administered was Pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Unspecified medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. No covid prior vaccination. No covid tested post vaccination. The patient experienced vomiting yellow liquid, severe chills and headache on 01Oct2021 19:00. The patient had third/booster dose (off label use and immunisation) on 01Oct2021. The patient did not receive any treatment for vomiting yellow liquid, severe chills and headache. The outcome of events vomiting yellow liquid, severe chills and headache were reported as recovered in Oct2021.   Follow-up attempts are completed. No further information was expected.
Swollen lymph nodes; pain; This is a spontaneous report from a contactable Nurse.  A 46-Year-Old male Nurse reported for himself that received the third dose (booster dose) of BNT162b2 (COMIRNATY, Solution for injection, Lot number: FF2090) in Arm  Right on 16Oct2021 around 16:30 (at the age of 46-year-old) at single dose for COVID-19 immunization. He states he received his initial two doses and then went for another booster shot. He received the first dose on 09Jan2021 (lot P12 EK9231 )  and the second dose on 30Jan2021 (P12 EN5318 ) Intramuscular injections. He mentioned he got a flu shot a week before the booster shot Intramuscular, left arm.  Patient history included Pre-diabetic. Concomitant drugs were none. On 17Oct2021, the lymph nodes on his arm where he got the shot in his right arm started swelling, he started to feel it in the morning. Then were real swollen.  He stated he considered this event to be medically significant because he has pain too, but it is not life threatening. Swollen lymph nodes was reported as worsened. The event did not require a visit to Emergency Room or to Physician Office. The reporting nurse considered the swollen lymph nodes was related to the vaccine because he wasn't experiencing it before the vaccine.; Sender's Comments: Based on the temporal association, a causal relationship between the events and BNT162b2 is possible.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
PAIN AND SWELLING OF LEFT SUPRECLAVICULAR AREA, LEFT LEG PAIN.
Information has been received from a registered nurse referring to a patient of unknown age and gender. The patient was administered three doses of GARDASIL (intramuscular, lot #, expiration date and dose were unknown) on 08-NOV-2012, 03-MAR-2014 and 24-JUL-2014, respectively. No adverse effect was reported. Additional information has been requested.
On 10/10/2022, I had a sore throat, coughing, runny nose, some sneezing, muscle aches. The fever I recorded was 98.7, which is a degree or 2 that I normally measure. On 10/11/2022, I took COVID-19 home test in the morning and the result was unclear. It was a shadowy result. In the evening, I tested again. And the result was positive. We called the doctor, that Tuesday evening. The doctor prescribed a medication that started with M and the other name started with an L. On 10/14/2022 I started to feel better. And by the 10/15/2022, I felt pretty good. I tested 10/16/22 and I was still positive. And I continued to feel good through that week.
abcess teeth; 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 TOOTH ABSCESS (abcess teeth) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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 TOOTH ABSCESS (abcess teeth). At the time of the report, TOOTH ABSCESS (abcess teeth) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was reported.
Initially, the patient stated she felt like she was "on fire" and was lightheaded.  Walked back to clinic with assistance x 2 and placed supine with feet elevated.  No wheezing, no swelling of tongue or other oral structures, no hives, generalized mild erythema right upper arm near injection site.  Sensation of feeling "on fire" resolved relatively quickly once supine.  Patient took 25 mg Benadryl orally that she had brought with her per her physician's direction "just in case" although she has not had any prior reaction to vaccines.  As a child she had substantial erythema at site of bee stings that she "outgrew".  No further feelings of dizziness.  Walked to the vehicle, friend driving patient back to work.
Injection site - large area of redness, swelling with hard tissue at center - raised, hot to touch, itching, tingling, chilling and fever, generalized achiness of muscles, and flu like symptoms, headache - mild.
Narrative:  Patient was seen in home by home based primary care nurse, nurse had brough bivalent booster to administer to patient, when drawing up he noted on the vial it was said to be for either 0.25ml or 0.5ml dosing, per nurse "due to the patient having several health issues ( 40 DX listed on patients problem list), 0.25ml of Covid Bivalent Booster was given not 0.5ml". Outside of the facility/manufacturers recommendations. No ADRs noted post vaccination. Reporting done as medication was administered at a dose outside of guidelines.
About 10 min after HPV was given, staff heard a yell for help. Patient was lying on the floor holding her head. Mom said she turned around for a min, then as she turned, child fell from the table. Seemed to hit her body first then head on the floor. Patient was examined by Dr. Ice was applied to her head. She has a small lump on the left side of forehead and swollen bridge of her nose. She states she has a headache. No nausea or dizziness. She does not remember falling. Dr. wanted to get her on the table and keep her for a while. Patient was upset and wanted to go home. She stayed for about 15 min more while sitting on the floor. We got her up, Dr. walked her to check out, and asked if she needed help to the car. Mom said "No, I've got her." Patient is being seen again today on 3/14/19 for a follow up.
Pain in the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain in the injection site) 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.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Pain in the injection site). At the time of the report, VACCINATION SITE PAIN (Pain in the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.
Left arm has hard, red, knot warm to touch and redness goes to elbow. Pt given Zithromax, Triamcinolone cream.
Patient received both doses of Pfizer vaccine (#1 on 2/9/21, #2 on 3/2/21) and was fully vaccinated when he presented to the ED on 5/9/21 w/ 3 week h/o cough, shortness of breath,. Tested positive for COVID19 by PCR on 5/10/21. Patient treated w/ Remdesivir, Dexamethasone, and convalescent plasma. Was on ventilator. Expired on 5/16/21 due to Acute Respiratory Failure with Hypoxia, Pneumonia due to COVID-19.
Headache, Bleeding, Myalgia, Fever, triggered heavy painful menstrual cycle Narrative:
Patient received a Pfizer BioNTech Adolescent/Adult Vaccine (Lot# 301458A) that was stored in the regular freezer (-25 to  -15 oC) beyond 14 days. On 22JAN22 Pfizer responded to the Health Agency and Health Clinic that stability data does not support the use of the Pfizer Vaccine (Lot# 301458A). Pfizer further states decision to release or dispose of the product is the responsibility of HA. The CDC website states that if the manufacturer does not have the information to support the stability of the vaccine, repeat the dose immediately with no minimum interval.
pt recv vax & pt needed a third;22APR96 3rd dose of vax given;
Information has been received from a Licensed Practical Nurse (L.P.N.) referring to multiple unspecified patients of unknown age and gender. Information regarding relevant medical history and concurrent condition were not reported. On multiple unspecified dates, the patients were vaccinated with improperly stored (Oka/Merck) VARIVAX (dose, lot # and route unspecified). Information regarding concomitant medications was not reported. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Per father client c/o pain to arm which started on 11/02/2005 then on 11/3/2005 started feeling numbness and burning sensation when he bends elbow. Client was seen by Dr on 11/05/2005 and was told irritant in vaccine probably got into nerve. PMD plans to refer to neurologist it unresolved.
This spontaneous report was received from a Registered Nurse (R.N), reporting on her son, a 12 month old male infant. The patient had no pertinent medical history or concomitant medications. Drug allergies/reactions were not reported. On 18-JAN-2015, the patient was vaccinated with VARIVAX. Dose, route, lot #, expiration date and anatomical location were not provided. On 18-JAN-2015, after vaccination, the patient had an allergic reaction to VARIVAX injection including: swelling, hives and trouble breathing at the time of injection .The infant required an unspecified medical attention and received treatment for the events. It was not a product quality complaint involved. At the time of reporting the outcome of the events was unknown. The reporter considered the events to be related to VARIVAX. Additional information has been requested.
LITTLE HEADACHE; This spontaneous report received from a patient concerned a 72 year old male. The patient's height, and weight were not reported. The patient's past medical history included: stroke, and heart attack, and concurrent conditions included: open heart surgery, non smoker, and non alcohol user, and other pre-existing medical conditions included: Patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced little headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of little headache was not reported. This report was non-serious.
Two days post vax pt reported redness, tenderness and itching at injection site. ER physician diagnosed reaction to DT. Pt was treated with Vicodan and Keflex.
At 23:00, fever of 102 degrees rectally; motrin had been given at 16:00 and a second dose was given at 23:00.  Fever came down to 101.4 rectally.  Motrin given on 10/24/2003 at 07:00 for fever of 101.4 rectally.
Patient reported moderate swelling of left arm that extended to left clavicular area for less than 24 hours. Reports taking Claritin and using warm compress.