chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt states they got vaccinated with Typhoid, Hep B and IPV vaccines a little after noon on 30 April 2018 and felt nothing different after. Pt reports around 7pm they went to the movies and while there, they ate the only meal of the day, some popcorn and a soda. Pt reported they went home after the movies and it was after they got in bed that they had first symptoms of itching in the face. Pt states they took some over the count BENADRYL and was able to go to sleep but woke the next morning with swollen lips and itchy bumps on abdomen. Pt recalled during VAERS counseling that they just washed their bed sheets and uniform on Monday morning with a new detergent. Pt reports they now suspect detergent might have been cause of reaction as well. Pt. reports no history of allergic reaction or anything similar to current symptoms and allergic reactions.
ringing in the ears; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A 56 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Knee pain" (unspecified if ongoing). Concomitant medication(s) included: IBUPROFEN taken for arthralgia. The following information was reported: TINNITUS (non-serious), outcome "unknown", described as "ringing in the ears".  Additional information: The reporter was a husband reported for a 56-year-old female patient (wife). It was reported that, the patient had no chronic health conditions. Stated that, the patient was taking ibuprofen for knee pain. No other meds. Stated that, the event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
headache; upset stomach; malaise; tiredness; This case was reported by a consumer via call center representative and described the occurrence of headache in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11th May 2019, the patient received the 1st dose of Shingrix. On 16th May 2019, 5 days after receiving Shingrix, the patient experienced headache, upset stomach, malaise and tiredness. On an unknown date, the outcome of the headache, upset stomach, malaise and tiredness were not recovered/not resolved.   It was unknown if the reporter considered the headache, upset stomach, malaise and tiredness to be related to Shingrix.  Additional details were provided as follows: The outcome of headache, upset stomach, malaise and tiredness was reported as not recovered, however discrepantly reported as recovering in the source document. The reporter did not consent to follow up.
chills; Felt hot and cold; sweating one time; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 85 year-old female patient received bnt162b2 (COMIRNATY), administered in arm, administration date 08Oct2021 (Lot number: 30155BA) at the age of 85 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: TYLENOL. The following information was reported: CHILLS (non-serious) with onset 09Oct2021, outcome "not recovered", described as "chills"; FEELING OF BODY TEMPERATURE CHANGE (non-serious) with onset 09Oct2021, outcome "not recovered", described as "Felt hot and cold"; HYPERHIDROSIS (non-serious) with onset 09Oct2021, outcome "not recovered", described as "sweating one time".  Additional information: No family medical history relevant to adverse events. History: The caller took lots of medications but declined to provide that information. The patient was taking Pfizer Covid vaccine as she decided to get it. Vaccine was administered at (Privacy) Facility. Had the Pfizer shot last Friday (in the morning) and wanted to know how long the side effects would last. She wanted to know if chills was an adverse event after getting the Pfizer BioNtech Covid-19 Vaccine and wanted to know how long it would usually lasts. On the evening of 09Oct2021, she experienced chills (felt hot and cold, sweating one time and chills on another time). The caller got cold and then she got hot, she had chills and then she got hot. The caller was not running a temperature. She asked whether that was normal. Caller stated that she still experienced that. No investigation assessment. No prior vaccinations (within 4 weeks). No adverse events following prior vaccinations.   No follow-up attempts are possible. No further information is expected.
temperature that went up to 102; headaches; very fatigued; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headaches), FATIGUE (very fatigued) and PYREXIA (temperature that went up to 102) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Mar-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 an unknown date, the patient experienced HEADACHE (headaches), FATIGUE (very fatigued) and PYREXIA (temperature that went up to 102). At the time of the report, HEADACHE (headaches), FATIGUE (very fatigued) and PYREXIA (temperature that went up to 102) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102 (High) Temperature went up to 102.         No concomitant medications were reported. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: updated contact information (mail, address)and new event
REDNESS AND HOT TO TOUCH - LOCAL REACTION STARTED ONE WEEK AFTER INJECTION
Witnesses report that the patient made a snoring sound and was seizing in chair.   This was approximately 5 minutes after the immunization while the patient was in the waiting area. Upon discovery of his situation by a witness, the patient fell out of his chair and lacerated his eye, broke a tooth, and injured his nose (resulting in blood spraying from the roof of his nose). The immunizing pharmacist, upon being notified by a witness had a staff member call 911 and the other pharmacist gloved up and stopped the bleeding with cotton balls and pressure. EMS arrived and evaluated the scene. The pt reported to them that he has "passed out" after an injection in college.
SORE ARM AT INJECTION SITE FIRST DAY RESOLVED IN 48 HOURS. HEADACHE SECOND DAY RESOLVED IN 2 HOURS Narrative:
i got so sick wentto cvs to get something to get this mucus off my chest; could not talk; nois was leakin like hell; bitter tasting; Initial information received from on 09-Dec-2022 regarding an unsolicited valid non-serious social media case received via consumer/non-hcp.  This case involves an unknown age and unknown gender patient who stated i got so sick went to pharmacy to get something to get this mucus off my chest, could not talk, nose was leaking like hell and bitter tasting after receiving influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect influenza vaccine produced by unknown manufacturer (batch lot number, strength, form, expiry date: unknown) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient had non-serious events of i got so sick went to pharmacy to get something to get this mucus off my chest (productive cough), could not talk (aphasia), nose was leaking like hell (rhinorrhoea), bitter tasting (dysgeusia) (unknown latency) following the administration of influenza vaccine.  Action taken with influenza vaccine was not applicable.  It was not reported if the patient received a corrective treatment for the events.  Outcome: Unknown.
Client reported development of "pinches" in her lumbar spine about 2 hours after the COVID vaccine Pfizer which lasted about 5 minutes. The client developed fatigue and mild dizziness on 07/07/21 at night after receiving the vaccine. The client states she went to sleep and denied any persistent dizziness when she woke up the next morning. The client also developed blisters on the inside of her bottom lip the morning after receiving the vaccine. The client stated the blisters resolved after three days. The client states she woke up the morning after receiving the vaccine "drenched in sweat." The client denied shortness of breath. The client did not consume any medication for her symptoms. The client did not seek formal care for her symptoms. The client denies any chronic conditions. She does not take any medications regularly.
Red arm; swollen arm; Itchy arm after first dose of Shingrix; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of erythema of extremities in a 76-year-old female patient who received Herpes zoster (Shingrix) (batch number 55HA3, expiry date 02-JUL-2024) for prophylaxis.   On 01-MAY-2023, the patient received the 1st dose of Shingrix. On 02-MAY-2023, 1 days after receiving Shingrix, the patient experienced erythema of extremities (Verbatim: Red arm), swelling arm (Verbatim: swollen arm) and itchy upper limbs (Verbatim: Itchy arm after first dose of Shingrix). The outcome of the erythema of extremities, swelling arm and itchy upper limbs were resolved (duration 5 days).   It was unknown if the reporter considered the erythema of extremities, swelling arm and itchy upper limbs to be related to Shingrix.     It was unknown if the company considered the erythema of extremities, swelling arm and itchy upper limbs to be related to Shingrix.   Additional Information: GSK Receipt Date: 10-JUL-2023 The reporter called to report that the patient received Shingrix vaccine and day after vaccination she had a red, swollen, itchy arm for 5 days. The reporter did consent to follow up via email.
Student nauseous, sweaty, and vomited. Episode last about 10 minutes, gave student water and cold compress.  Student sat in administration room for an additional ten minutes and stated that he felt better, did not feel nauseous anymore. Advised parent to follow up with doctor.
Site: Bruising at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Nausea-Mild
A non-serious spontaneous report of "administration of expired product" and "vaccine given to a patient" was received from a non healthcare professional concerning a 80-year-old female out of 18 patients. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired on 15-Jan-2010. On 20-Jan-2010, the patient received expired H1N1, Intranasal. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event was considered resolved.
Moderna Covid-19 Vaccine EUA: Patient noticed redness, swelling, itching and pain in the left arm where covid vaccination was given. She reported noticing this on day nine after vaccination in the late AM. Patient reports that she started taking Benadryl and Pepcid on that day for a cycle of 24 hours and cold compresses intermittently. Redness and swelling returned on 02/09/21. Patient also reports intermittent numbness that resolves on its own. RN and I looked over arm and felt for any swollen lymph nodes, none noticed. We discussed with to go see PMD, which she has been in contact with.
Patient this morning noticed area was tender but not concerned.  Around 4:30pm when patient was changing for the gym, she noticed the swelling and redness was spreading and tender to the touch but minimal pain.  She also experienced mild nausea throughout the day.  She will continue to monitor arm to see if irritation continues to spread.  Will also use OTC tylenol and topical benadryl to treat current symptoms.  No trouble with range of movement with arm.
LOCALIZED REDNESS TO DELTOID APPROX 12X8 CM. RECOMMENDED TO TAKE BENADRYL.
sore arm with the other couple doses; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm with the other couple doses) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm with the other couple doses). At the time of the report, PAIN IN EXTREMITY (sore arm with the other couple doses) outcome was unknown.            Concomitant medications was not provided by the reporter. Patient  had a sore arm with the other couple doses. She got the full hundred ccs dose with the booster. Treatment information was not provided.    This case was linked to MOD-2022-538679, MOD-2022-538686 (Patient Link).
No adverse event reported. Pt was given vaccine too early per guidelines for time between PNEUMOVAX 23 (given 7/7/15) and PREVNAR 13 (given 10/14/15).
pt recv vax 3JUN97 & 11JUN97 pt devel als fever & 2 chickenpox;
Headache; Kind of tight lumps in my throat like hard swollen; kind of difficulty; Tired; Jaw very stiff like it was pulled down; Blood pressure has been up; Anxiety; thought I have become an allergies reaction; This is a spontaneous report from a contactable consumer or other non hcp (Patient). A female patient of an unspecified age of height about 5feet 2 inches and weight probably about 148 (pounds)received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: Unknown), dose 1 via an unspecified route of administration on 01Apr2021 as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date on Thursday after the first dose she got a headache and that come up well, it was pretty normal, the headache. Probably about ten minutes after she started seemed like kind of tight lumps in her throat like kind of hard swollen. She thought she had allergic reaction because she reported to have lots of allergies to medications (unspecified medication) and other things too that happened. She also reported vaccination site" (not clarified) all this happening with the vaccination, about the swallowing and all about the tightness, had this probably about an hour. She wished she was in an ER(not clarified). She reported to have gone home and checked the history if it help but she was tired and slept but woke up with Jaw very stiff like it was pulled down. She asked if that was a normal side effect with jaw stiffness. Her blood pressure was up since then. She was concerned about her blood pressure, possibly anxiety related but she don't do this so, may be an allergic reaction." On an unspecified date patient received dose 2 of Covid-19 vaccine. Outcome of all the events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.      No follow-up attempts are completed; information about lot/batch number cannot be obtained.
I was having chest pains that woke me up with dull achy chest pains on my left side. I tried to wait it out for a  couple of hours and nothing improved so I went to the ER 12/31/20 and they did EKG and other tests. They medicated me with Ibuprofen and sent me home. The next day I had to go again because the pains were worse. At the ER at 01/01/2021 they redid the same tests and all came back normal. I still feel the chest pains not as strong they come and go. I had them yesterday but not today. My PCP does not know what to do and prescribed me XANAX to keep me from getting stressed and making it to come back. My employer suggested doing a COVID test but I had not had a chance to go and have it done yet.
Patient is an 85-year-old male  sent from ophthalmology clinic due to concern of  blackening of vision. Homonymous right superior quadrantopia likely 2/2 prior ischemic insult.
one week after the shot the area it was given has swelled into a knot, redness, tender, itchy and painful, tight chest and sore armpit  have been icing the area and taking benadryl but nothing fully eliminates it from hurting
Chest tightness;  shortness of breath; tingling of the lips and tongue; hives on face, neck, upper body. Symptoms lasted around 12hrs "overnight". Benadryl X2 doses. Followup with PCP.
pediatric nurse practitioner states they gave some pediatric 6m-5y after the BUD; The vial was initially stored in the refrigerator on 23-Dec-2022 and was administered after 30-day use by date; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (pediatric nurse practitioner states they gave some pediatric 6m-5y after the BUD), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 23-Dec-2022 and was administered after 30-day use by date) and NO ADVERSE EVENT (No adverse event) in a child patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 216K22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (pediatric nurse practitioner states they gave some pediatric 6m-5y after the BUD), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 23-Dec-2022 and was administered after 30-day use by date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (pediatric nurse practitioner states they gave some pediatric 6m-5y after the BUD), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 23-Dec-2022 and was administered after 30-day use by date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (pediatric nurse practitioner states they gave some pediatric 6m-5y after the BUD) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 23-Dec-2022 and was administered after 30-day use by date).    No concomitant medications were reported.     It was unknown if patient had received any other vaccines in the 4 weeks prior to COVID-19 vaccine. The pediatric nurse practitioner stated they gave some pediatric 6m-5y after the BUD. Total 42 dose was administered after 30-day Use By Date. The Bivalent 6m-5y vial of 0.4 mL (Lot number: 216K22A) was initially stored in the refrigerator on 23-Dec-2022. The vaccine was administered on 26-Jan-2023, 27-Jan-2023, 30-Jan-2023, 31-Jan-2023 2-Feb-2023, 6-Feb-2023, 8-Feb-2023, 10-Feb-2023, 13-Feb-2023, 14-Feb2-023, 16-Feb-2023, 17-Feb-2023, 21-Feb-2023. The vial did not undergo any temperature excursions.  No treatment medications were reported.  This case contains information for the 35th of 42 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-718298 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-718298:Master case
Headache, dizziness, nausea, back pain, flank pain, low grade fever, chills, sweats, rash, malaise, myalgia Treated with 1gm Tylenol, 800mg Motrin, 81mg ASA, 8mg Zofran, 10mg Zyrtec
Fever; Fainting (15h post injection); Increased HR; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (Fainting (15h post injection)) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018B21A and 039A21B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ADALIMUMAB (HUMIRA) for an unknown indication.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Apr-2021, the patient experienced SYNCOPE (Fainting (15h post injection)) (seriousness criterion medically significant). 18-Apr-2021, the patient experienced HEART RATE INCREASED (Increased HR). On 19-Apr-2021, the patient experienced PYREXIA (Fever). At the time of the report, SYNCOPE (Fainting (15h post injection)) had resolved and HEART RATE INCREASED (Increased HR) and PYREXIA (Fever) outcome was unknown.            Treatment received in response to the event was acetaminophen.  Company Comment: 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.; 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.
This spontaneous report as received from a pharmacy technician concerning a currently 21 months old child. Gender was not reported. Medical history and concurrent conditions were not reported. On 13-MAR-2014, the patient was vaccinated with VARIVAX lot #J007955; expiration date: 27-JUN-2015, (dose, strength and route were not reported). Secondary and concomitant therapies were not reported. Patient was vaccinated with VARIVAX that was exposed to 43.1 degrees F for 29 hours on 03-MAR-2014. This is one of several reports from the same reporter. Additional information has been requested.
This spontaneous report as received from a physician refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX lot # M034583, expiration date 27-JUL-2018 or lot # M040139 with expiration date of 28-SEP-2018 (dose and route of administration were not reported). The vaccines were reconstituted with properly stored sterile diluent (STERILE DILUENT). There were no adverse effects reported. Administered doses of vaccines underwent the temperature excursions from 6 degrees Fahrenheit to 14 degrees Fahrenheit for 1 hour 10 minutes and from 15 degrees Fahrenheit to 46 degrees Fahrenheit for 2 hours and 15 minutes (date unspecified). Data logger was involved. There were no previous excursions reported. No product quality complaint was involved. This is one of two reports received from the same reporter.; Sender's Comments: US-009507513-1709USA002957:
Pt recvd 3 doses of Engerix-B & it was determined that pt was a non-responder;