chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Not able to eat; My head is hurting really bad.; Chills; This is a spontaneous report from a contactable consumer (patient itself). A 23-years-old patient of an unspecified gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: EW0187), via an unspecified route of administration, in the left arm on her shoulder, on 25May2021 (reported as yesterday) as 1ST DOSE, SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unknown date, the patient was not able to eat, head was hurting really bad and chills. The patient took Tylenol as treatment for the adverse events. The outcome of the events was unknown.  Information on the lot/batch number has been requested
Starting on or around 10jul22, woke up with mild sore throat and congestion. Got somewhat more severe and feeling tired. The next day I did the home test which was negative. The next day I was feeling more tired and congested and tested positive. I called my doctor after that. Doctor prescribed Paxlovid. The congestion progressed to the cough  and the other symptoms reduced after 24 hours of the taking Paxlovid.
Subjective fever highest recorded 99.5, chills, myalgias, and fatigue.
Patient seemed to have a delay of the adverse reaction starting a few days (4 to 5 days) after immunization. The patient experienced a very sore arm and could hardly move her arm. The patient called the pharmacy on Monday morning January the 18th and I continued to check on her several times until  Thursday the 21st and on this day she stated all her symptoms have subsided.
Pt. had fever as high as 101, on 5/20, 5/21.  Days later, he was noted to not move his right hand and right leg.
gave a Kinrix vaccine to a 4-month old baby; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 4-month-old patient who received DTPa-IPV (Kinrix) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional case details were reported as follows: The reported stated that one of his nurse gave a Kinrix vaccine to a 4 month old baby by error, which led to inappropriate age at vaccine administration.  At the moment of the call pharmacist did not have any patient´s details or exact date of occurrence so he asked for time to reach out with the nurse. The reporter consented to follow up.
chest tightness, hard to take a deep breath. Patient received Benadryl 50mg IM
hives on the arm from her shoulder to her elbow on the inside and outside of the arm with itching and one hive on the left arm; she could not sleep on it; right arm was painful and swollen at the injection site hot to touch and she couldn't sleep on it; right arm was painful; swollen at the injection site; injection site was hot to touch; Initial information regarding an unsolicited valid non-serious case was received from a consumer via agency (Reference number- 00360572) and transmitted to Sanofi on 16-Nov-2020  This case involves a six-year-old female patient who experienced hives on the arm from her shoulder to her elbow on the inside and outside of the arm with itching and one hive on the left arm (urticaria) and right arm was painful and swollen at the injection site hot to touch and she could not sleep on it (vaccination site inflammation, vaccination site pain, vaccination site swelling, vaccination site warmth and insomnia), while she received INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), concomitant medications and family history were not provided.  It was reported that she was not allergic to eggs but they are going to ask if she can see an allergist since she had this experience last year with the influenza vaccine but feels this year was worse and reporter does not want patient to go through that again.  On 11-Nov-2020, the patient received a 0.5 mL dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number and expiry date not reported via an unknown route in the right arm for prophylactic vaccination.  On 13-Nov-2020, the patient's right arm was painful and swollen at the injection site hot to touch and she could not sleep on it (vaccination site inflammation, vaccination site pain, vaccination site swelling, vaccination site warmth and insomnia) 2 days following the administration of INFLUENZA VACCINE.  On 15-Nov-2020, the patient developed hives on the arm from her shoulder to her elbow on the inside and outside of the arm with itching and one hive on the left arm (urticaria) 5 days following the administration of INFLUENZA VACCINE.  Other relevant tests not reported.  The patient was treated with topical cortisone cream and diphenhydramine hydrochloride (benadryl childrens).  At the time of reporting, outcome was unknown for the events.  There will be no information on the batch number for this case.
AFTER VACCINATIONS WERE GIVEN BY PROVIDER, IT WAS NOTED INJECTION REACTION IN PT WAS PALE, HAD SOME SHAKINESS, PROVIDER GAVE WATER AND PT WAS INSTRUCTED TO SIT IN CHAIR TO REGAIN HER COMPOSURE, I ENTERED THE ROOM AS PROVIDER LEFT. PT STATED THAT SHE WAS FEELING BETTER, STOOD TO GET MORE WATER, FELT OK, TURNED TO SIT IN CHAIR THAT IS WHEN SHE LOST ALL COLOR IN HER FACE, STARTED TO SHAKE AND AS SHE BEGAN TO FALL TO THE FLOOR I IMMEDIATELY KNEW WHAT WAS HAPPENING, HAD PT FALL TOWARDS MYSELF AND LOWERED HER TO THE FLOOR, WHERE THE PROVIDER WAS CALLED TO THE ROOM, A PILLOW WAS PLACED UNDER THE PT'S HEAD AND WE TALKED TO HER UNTIL SHE REGAINED FULL CONSCIOUSNESS, PLACING A COOL WET TOWEL TO HER FOREHEAD. PT CONTINUED TO LAY ON THE FLOOR UNTIL SHE WAS ABLE TO SIT UP WITH OUT FURTHER REACTIONS, THEN SHE WAS ALLOWED TO STAND NEAR ME. DURING THAT PROCESS THE PT REGAINED COLOR IN HER FACE AND WAS TALKING AND JOKING WITH HER SISTER WHO WITNESSED THE EPISODE. PT WAS INSTRUCTED TO SIT UNTIL THE PROVIDER AND MYSELF FELT THAT SHE COULD WALK UNASSISTED WITH HER MOTHER AND SISTER. PT WAS NOT INJURED WHEN SHE WAS LOWERED TO THE FLOOR.
Cellulitis infection; Right ankle pain; Body pain; Joint pain; A spontaneous report  was received from healthcare professional concerning a 59-year-old male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced cellulitis infection, joint pain and right ankle pain, and body pain.  The patient's medical history included hypertension, cirrhosis of the liver, splenomegaly, sarcoidosis of the lung, diabetes, and having varicose veins in the stomach.   No relevant concomitant medications were reported.  On 22 Dec 2020, the patient received his first of two planned doses of mRNA-1273 (Lot 011J20A) intramuscularly in the right upper arm.   On 19-Jan-2021, prior to the onset of the events, the patient received his second of two planned doses of mRNA-1273 (Lot number: 029L20A) intramuscularly in the left upper arm for prophylaxis of Covid-19 infection.   On 22 Jan 2021, the patient experienced a joint pain and body pain. On 25 Jan 2021, the patient experienced right ankle pain.   On 28 Jan 2021, the patient experienced a severe cellulitis infection in his arm and was hospitalized from 28 Jan 2021. The patient was discharged from hospital on 08 Jan 2021.  Treatment for the events included Cetaphil (reported as IV) and cephalexin (antibiotic).  Action taken with mRNA-1273 in response to the events was not applicable.  The outcome of the events joint pain and body pain were resolved on 25 Jan 2021. The outcome of the event right ankle pain was resolved on 28 Jan 2021. The outcome for the event of cellulitis infection was unknown.; Reporter's Comments: Very limited information regarding this events has been provided at this time.  Further information has been requested.
PE, cor-pulomonale requiring catheter directed thrombolysis and remains critically ill.
lightheadedness; dry eyes; Differential Diagnosis: Vaccine-Related Anxiety (include misc mental health) and Systemic reaction (hypoglycemia, hypotension, generalized rash); Differential Diagnosis: Vaccine-Related Anxiety (include misc mental health) and Systemic reaction (hypoglycemia, hypotension, generalized rash); Differential Diagnosis: Vaccine-Related Anxiety (include misc mental health) and Systemic reaction (hypoglycemia, hypotension, generalized rash); Differential Diagnosis: Vaccine-Related Anxiety (include misc mental health) and Systemic reaction (hypoglycemia, hypotension, generalized rash); elevation of bp; This is a spontaneous report from a non-contactable Other-HCP. A 69-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot Number: EN6205) as DOSE 1, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient reported 15-minute after the injection, began to experienced lightheadedness and dry eyes and Differential Diagnosis: Vaccine- Related Anxiety (include misc. mental health) and Systemic reaction (hypoglycemia, hypotension, generalized rash) on an unspecified date.  She denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, dizziness, facial swelling, lip swelling and tongue swelling. Treatment included: water and snacks. Monitored/observed for 25 minutes. Patient reports improvement in overall symptoms. She feels good to go home. Patient has husband with her today and he will be driving. Patient encouraged to monitor her blood pressure elevated. Anxiety/stress response suspected causing elevation of bp. The event outcome was recovering.  No follow-up attempts are possible. No further information is expected
Swollen L upper arm, red, painful, itchy started day after shot's rec'd.  Improved with BENADRYL.
Pt vaccinated with Meruvax II on 18AUG89. A rubella titer on 3OCT89 was 0.82. No further details were provided.
Moderna COVID- 19 Vaccine EUA Received Moderma dose left deltoid on 1/6/21, lot # 012L20A, exp. July 6, 2021 Day after injection, there was some itching and redness. She iced it and it mostly resolved by 1-9-21 or 1-10-21. Ibuprofen tried. On 1-13-21 recurrence of itching and increased size of redness - seen at Employee Health this day. No other symptoms, no fever, no joint or muscle aches. In the past, will sometimes get small 'knot' with flu vaccine, that itches, and resolves in a few days. No chronic medical problems.  Evaluated at Employee Health. Diagnosis: allergic reaction, persistent vs. Arthus type local reaction. Plan: antihistamine/H2 blocker/recheck 1 week.
Breakthrough case admission after 3 vaccines Pfizer 2/24/21 Lot# EN6200  Pfizer 3/18/21 Lot# EN6208;  Pfizer 10/2/21 Lot# FF2588
body aches; Ongoing "intense dreams"; pain (especially in lower back/hips); thrashing at night over the next two weeks; loss of appetite; lethargic on the next day; sore arm; fever; pain (especially in lower back/hips); This is a spontaneous report received from a contactable female consumer (patient). A female of unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, batch/ lot number unknown) via unspecified route of administration on unspecified date as DOSE 2, SINGLE for COVID-19 immunisation. The patient's medical history included multiple sclerosis, allergies, food intolerances. The patient was on an immunomodulator medication. Patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, batch/ lot number unknown) via unspecified route of administration on unspecified date as DOSE 1, SINGLE for COVID-19 immunisation. The patient experienced sore arm, fever, loss of appetite, body aches and pain (especially in lower back/hips), and lethargic on the next day, ongoing intense dreams and thrashing at night over the next two weeks. The outcome of events was unknown.  No follow-up attempts were possible. No further information was expected.
pt recv vax 1PM 3NOV97 & was given APAP 1hr later;8PM 3NOV(7 T102.3 ax more APAP;irritable, lt arm red, & sl knot @ inj  site;nothing done for arm;tub bath given 10PM & 4AM 4NOV(7;temp then 100 ax;sometime this AM 4NOV97 temp 100 ax;
?Left shoulder blade (scapular) pain radiating to the front left chest. Treated with Aspirin regimen, 325mg Bayer Safety Coated Aspirin, 1 every 8 hours, 4 days to resolution and discontinuation of medication. ?Gastrointestinal issues (GERD). Treated with Protonix 40mg, 1 daily, 5 days to resolution and discontinuation of medication. ?Muscle aches with chills. Muscle ache flared up a trigger point in left shoulder. Treated with Robaxin-750mg, 1 to 2 every 8 hours as needed. 3 days to resolution and discontinuation of medication.
Small red bump next day, did not get better, mom monitor then got larger, red, inflamed, hot to touch, took child to pediatrician, took antibiotic did not  get better went to ER & ultrasound  discover abscess
Patient presented to the ED on 7/15/19 with complaint of itchy rash. Patient received zoster vaccine and pneumococcal 23 vaccines on 7/10/2019 and stated he initially had hives after the vaccine administration. Physical exam on 7/15/19 revealed erythematous scattered rash without hives. Per ED discharge note, Patient has taken diphenhydramine which helped relieved symptoms. Patient was prescribed prednisone taper and camphor/menthol lotion outpatient. Patient was discharged from the ED on 7/15/19.
Since the initial vaccination, Patient has and continue to have extreme pain in her legs and arms, to include occasional swelling in her joints. It is also very difficult for her to walk or get around without the aid of a wheelchair or walker.
Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms; 38 have improvement of symptoms; No adverse event; This spontaneous case was reported by a physician and describes the occurrence of OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms), THERAPEUTIC RESPONSE UNEXPECTED (38 have improvement of symptoms) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19.     No Medical History information was reported.    On an unknown date, the patient received third 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 OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms), THERAPEUTIC RESPONSE UNEXPECTED (38 have improvement of symptoms) and NO ADVERSE EVENT (No adverse event). At the time of the report, OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms) had resolved and THERAPEUTIC RESPONSE UNEXPECTED (38 have improvement of symptoms) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      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 OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms) and THERAPEUTIC RESPONSE UNEXPECTED (38 have improvement of symptoms).    No concomitant medications were reported. No treatment medications were provided.  Patient 30 out of 42 patients   This case was linked to US-MODERNATX, INC.-MOD-2023-735199 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 22-Aug-2023: Live follow up received on 22-Aug-2023; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-735199:
Information has been received from a registered nurse concerning a 15 year old male patient with no pertinent medical history and no allergies who on 17-JUN-2010 was vaccinated intramuscularly with a dose of PNEUMOVAX 23 (lot# reported as 1938Y). There was no concomitant medication. On 18-JUN-2010 the patient developed fever, low blood pressure, nausea and rash and was hospitalized. The patient was given steroids and an antibiotic while in the hospital. On 20-JUN-2010, the patient was discharged from the hospital. At the time of this report, the patient had recovered from fever, low blood pressure, nausea and rash. Additional information has been requested.
Child positive for Rotavirus 4/2/19.  She received RotaTeq vaccine on 7/30/18, 11/1/18, and 12/4/18.  Just wanted to make report due to child receiving full vaccine series and then positive for Rotavirus on 4/2/19.
This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 52-year-old male patient who received Herpes zoster (Shingrix) (batch number K7T79, expiry date 14th April 2023) for prophylaxis. Previously administered products included Shingrix (received 1st dose in December 2019). On 1st December 2021, the patient received the 2nd dose of Shingrix. On 1st December 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown. Additional details were provided as follows: The patient due to a combination of COVID-19 pandemic and moving did not receive second dose of series until 1st December 2021. The patient received 2nd dose on 1st December 2021, later than the recommended time interval, which led to lengthening of vaccination schedule. The reporter consented to follow up.
REACTION TO VACCINE; This spontaneous report received from a consumer via a company representative via social media concerned a female patient of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown and expiry: Unknown) dose was not reported, 1 total, start therapy date were not reported, administered for prophylactic vaccination (Dose series 1). The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient died from reaction to vaccine. It was unspecified if an autopsy was performed or not. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0 20211212807- COVID-19 VACCINE AD26.COV2.S-Reaction to vaccine. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: REACTION TO VACCINE
Seizure 24 hours following vaccine  6-12 days following vaccine fever runny nose cough and measles rash.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Sep2023 at 09:45 as dose 4 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid on 20Sep2023. The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Patient became nauseous, lightheaded, and had momentary syncopal episode.  Pt. was hypotensive @ 80/40 but BP rebounded after pt. was laid on cough with feet elevated. BP 112/66 upon patients release from clinic.
Patient has known Severe POTS syndrome with know AV Block Mobitz 1     25 minutes after vaccination the patient had a passing out episode accompanied by petit mal seizure.  Patient resumed consciousness after 4 minutes.   Patient was transferred to Emergency Room.    Vitals were stable.
102 temperature Severe headache Severe muscle and joint aches In bed for 2 days
Tested positive for Covid on April 12, 2022. Symptoms were consistent with a very bad cold... serious congestion in the sinus and lesser so in the chest. Only minor fever/chills. Outside of general fatigue that comes with a cold, no other identifiable symptoms.  One week later, it?s still clearing up, but much better.
w/in 2hrs p/shot began eryth indurated area which overnoc grew to 9.5 x 3.5 w/o pus or fluctuance
One week post 1st vaccine, developed localized red area at injection site approx. 3 inches in diameter, warm to touch, slight itching.