chrisvoncsefalvay/vaers-outcomes huggingface dataset:
After received PPV23 vaccine developed itching and a round circle at site of injection. Given BENADRYL and ice pack. Advanced to Erythema from shoulder to elbow. Went to M.D KEFLEX for 10 days cellulitis.
Pt recvd vax & 24 hrs p/vax pt felt poorly; 48 hrs p/vax pt was very ill w/flu-like sx; No further details were provided;
Pt admitted to the ED with chest pain one day following the vaccination. Pt described this as subtle at first that increased to wake pt up in pain. Sharp pleuritic pain localized in the center of her chest and slightly in the epigastric region. No prior symptoms previously. Pt has been diagnosed with bilateral pleural effusion, acute pericardial effusion and acute pulmonary embolism.
Covid arm - red, swollen, itchy fever, headache, nausea for 36 hours Burped all day the next day Have burped everyday since the first vaccine on 7/31, still has not stopped
Pt recvd PNU-IMUNE 23 in 1989; Pt devel intense pain @ inject site then loss of deltoid function, pt seen by neurologist who states that 3 nerves in the shoulder area are involved;
No other AE; Caller is a nurse who reports that PROQUAD and VARIVAX may have been given after a temperature excursion that occurred in April 2022. Vaccines were then sent back to the agency so she does not have time/temperature data and does not know whether any vac; This spontaneous report was received from a registered nurse and refers to a 4-year-old male patient. Information regarding the patient's concurrent conditions, medical history, historical drugs and concomitant therapies was not provided.  On 14-APR-2022, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot #U019289, expiration date: 15-DEC-2022, administered subcutaneously in the right deltoid for prophylaxis (product storage error), it was mentioned that there was not previous temperature excursion. No additional adverse event was reported.  This is one of four reports received from the same reporter.; Sender's Comments:  US-009507513-2208USA009203: US-009507513-2209USA003333: US-009507513-2209USA003334:
Vaccine stored in refrigerator on 10/18/2021, expired product 10/13/2021, administered date on 10/26/2021; 606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine stored in refrigerator on 10/18/2021, expired product 10/13/2021, administered date on 10/26/2021) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine stored in refrigerator on 10/18/2021, expired product 10/13/2021, administered date on 10/26/2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine stored in refrigerator on 10/18/2021, expired product 10/13/2021, administered date on 10/26/2021) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment information was not provided. On 18-Oct-2021, the vial was initially stored in the refrigerator. The Vial did not go undergo any temperature excursion. The patient received the booster dose. The patient had no any adverse event post administration of expired vaccine.
pt recv vax 27MAR95 2PM & on 28MAR95 7PM exp sz; pt taken to ER-t104; post ictal state; pt looked cross eyed; cried out; t103R, P208, R40, BP 114/80; eyes rolled back, mottled, trembling; dx febrile sz; not acting nl;
Rash at injection site, large raised area at injection site, pain and difficulty lifting arm at injection site,  redness at injection site, tiredness, muscle pain throughout body, fever.
Rash began AM of 11/16/05 noted 1st on nape as small dots various sizes then 11/17 spread to arms, legs, chest, head, scalp increased number of spots, size remained same ~5mm diam some with a "target" on nape; concentrated in warm area of body (axilla, scalp), some with pinpoint central vesicle; on 11/18/05 Pt awoke with swollen eyelids L almost closed, swollen hands and feet.  Fever to 100 F rectal & diffuse rash 1-2 cm diam macular with central vesicle-Pt given 20mg oral prednisone in office and 1mg 1cc/dose every 12 hrs for 3 days-until rash disappeared on 11/21/05.  EM-serum sickness
Tinnitus; 3rd booster made me feel flu-like for 24 hours; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date Dec2021 (Lot number: FL3198) at the age of 37 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EL3247), administration date: Mar2021, when the patient was 36 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3302), administration date: Feb2021, when the patient was 36 years old, for COVID-19 Immunization. The following information was reported: TINNITUS (non-serious) with onset Feb2022, outcome "not recovered", described as "Tinnitus"; INFLUENZA LIKE ILLNESS (non-serious), outcome "recovered", described as "3rd booster made me feel flu-like for 24 hours". The events "tinnitus" and "3rd booster made me feel flu-like for 24 hours" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of tinnitus, influenza like illness.  Additional information: Seriousness criteria's was assessed as non-serious by reporter. No other vaccine in four weeks. Tinnitus onset mid-February 2022, approximately 1 month after COVID. Unsure if Tinnitus is related to Covid itself or vaccine. No after 1st and 2nd shots. Started after patient's Covid diagnosis and patient's 3rd shot. 3rd booster made patient feel flulike for 24 hours. Covid itself was extremely mild, just a low fever and some congestion. Mostly right ear - no ear infection found or other symptoms/pain. Never had ear issues in my life before except occasional very brief bouts of tinnitus. But now it's almost constant  whooshing sound sometimes, buzzing sometimes, and most awful, a sound like a low foghorn in patient's right ear. Extremely distracting and interferes with patient's job as a therapist, in which patient must focus and listen to patient's clients all day. AE resulted in was doctor or other healthcare professional office/clinic visit. No COVID prior vaccination. COVID was tested post vaccination. Test type post vaccination was nasal swab, done on Jan2022 and COVID test result was positive.  Follow-up attempts completed. No further information expected.
SAT Am woke up w/red raised pustules began on trunk then spread to body Monday;fever Sunday AM only 103 highest;
Initial and follow-up information has been received from a physician concerning a 16 month old female with no illness at the time of vaccination and no drug reactions/allergies who on 29-NOV-2007 was vaccinated with a third dose of COMVAX (lot#657380/0377U) in the left arm IM. Concomitant therapy included PREVNAR (lot# "BG8702E") in the left arm IM. On 09-DEC-2007, 10 days post vaccination, the patient developed a rash over her entire body. There was no localized reactions at the injection site. It was unknown if any AE was involved with the first or second vaccinations. The patient received unspecified medical attention and subsequently, the patient recovered on 17-Dec-2007. Additional information has been requested.
On 09-28-23 the employee reported not feeling well and thought she was starting to have a migraine.  Left work early and reported having diarrhea and vomiting.  Woke up after resting for several hours and her left arm had large red splotches and pain at the injection site.  Pain continued into left upper trunk.  She is alternating tylenol and ibup for symptom relief.
I had an exacerbation of my myasthenia gravis about 1 week later. This is the second consecutive year in a row that I received the influenza vaccine and had a myasthenia exacerbation about 1-2 weeks later.
Approximately 12 hours after receiving the booster dose, she awoke feeling extremely ill and nauseous, roused me to say so, and then immediately became unresponsive and pulseless. She was admitted to hospital for cardiac work up, and all diagnostic tests have found her heart to be normal in structure and function. Cardiology believes she experienced a vasovagal syncope with asystole. She remains hospitalized at this time for initiation of sotalol therapy; she was diagnosed with frequent PVCs approximately 1 year ago.
Immediate pain following vaccine administration; decreased strength and range of motion; unable to lift arm over head; alleviated by high doses of Ibuprofen; injection given near top  of left shoulder. Pain x 4 weeks.
almost ended her life after her 48th dose at 4 years old; Our daughter passed out the day of her 4 year vaccines; she was left with brain inflammation or in other words, autoimmune encephalitis; Vaccines caused our daughter seizures after 1 year vaccinations; full loss of words at her 18 month vaccines; slept for 3 days straight; What didn't come back normal were her titers for when she was vaccinated/labs showed greater than 300; This spontaneous report was received from the mother of the patient referring to her daughter a female patient of unknown age. The patient's concurrent conditions and medical history were not reported. There was no concomitant medication reported.  On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) (dose, strength, route, lot number and expiration date were not reported) and other unspecified vaccines administered for prophylaxis. The reporter mentioned that vaccines caused to her daughter seizure after her 1 year vaccinations, full loss of words at her 18 months vaccines and almost ended her life after her 48th dose at 4 years old (Ill-defined disorder). She also mentioned that her daughter passed out the day of her 4 years vaccines and slept for 3 days straight. She said that doctor tested her for every disease and illness they could think of, but everything came back normal. But what did not come back normal were her titers for when she was vaccinated against. She said that people need a titer of a 1.1 for immunity; however, her daughter's labs showed greater than 300 (units not provided). She did not know if her titer was 3.000 or 300.000 but the test stopped at 300. She also said that her daughter was left with brain inflammation or in other words, autoimmune encephalitis.  At the reporting the outcome of the adverse events was unknown.   The reporter considered Ill-defined disorder as a life-threatening event. Upon internal review the events seizure, encephalitis autoimmune and loss of consciousness were considered as medically significant. The reporter considered all events as related to the vaccines.
Severe pain, in the left Pudental nerve, affecting all normal functions. Various treatments, to no good effect. Unremmitting, and still severe, 15 months later.
After my second dose, a red patch started showing up under my left eye; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 23-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Mar2021 as dose 2, single (Lot number: EN6202) at the age of 22 years for covid-19 immunisation. The patient's relevant medical history included: "If covid prior vaccination: Yes" (unspecified if ongoing), notes: If covid prior vaccination: Yes; "Known allergies: Eggs" (unspecified if ongoing), notes: Known allergies: Eggs; "Known allergies: Hazelnuts" (unspecified if ongoing), notes: Known allergies: Hazelnuts; "Ibs" (unspecified if ongoing), notes: Other medical history: Ibs; "Eczema since little" (unspecified if ongoing), notes: Other medical history: eczema since little. There were no concomitant medications. Vaccination history included: BNT162b2 (Prev dose product: COVID 19,, Prev dose brand: Pfizer,, Prev dose brand unknown: False,, Prev dose lot number: EM9810,, Prev dose lot unknown: False,, Prev dose administration date: 09Feb2022,, Prev dose dose number: 1), administration date: 09Feb2021, when the patient was 22-year-old, for COVID-19 immunization. The following information was reported: RASH (non-serious) with onset 2021, outcome "unknown", described as "After my second dose, a red patch started showing up under my left eye". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of rash.  Additional information: The patient did not received any other vaccine in four weeks and did not received any other medications in two weeks. After her second dose, a red patch started showing up under her left eye. It would come and go. Treatment included allergy tests, blood tests, and antihistamines. Covid test type post vaccination included nasal Swab, covid test result: Negative.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201033362 Same patient and drug, different event separated in time;
cold, cough, shortness of breath, headaches, stomach pains, diarrhea, low grade fever, lethargy
Chills; Headache; Very tired; Arm was also very sore.; This is a spontaneous report from a contactable consumer. An adult non-pregnant female patient of unspecified age received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 01Mar2021 at 18:00 as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. It was not sure if the patient had received any concomitant medication. It was unknown whether the patient received any other vaccines within four weeks prior to the vaccination. On 02Mar2021 at 18:00, 24 hours after vaccination, the patient experienced chills, headache, very tired and arm was also very sore. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. It was unknown if the patient received any treatment for the reported events. Since the vaccination, it was unknown whether the patient had tested for COVID-19. The clinical outcome of the events chills, headache, very tired and arm was also very sore was recovered on an unknown date in Mar2021.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
lab confirmed hematochezia.  historically first on 9/28/2020.  lab + hemoccult 10/2/2020.  seen in office on 9/30/2020.  three neg hemoccult stool prior to the + one on 10/2/2020 and coinciding with grossly visible blood
WOKE UP FEELING WEAK, INCREASED SHAKINESS, MARKED MENTAL CONFUSION. CONTINUED THROUGHOUT THE DAY
COVID-19 Vaccine EUA; chills, nausea, and fatigue, started about 4 hours after the vaccine. It was enough to have me stop and lay down. Lasted about 5 hours except the fatigue which lasted for a few days.  The fatigue was more than my usual fatigue.
Patient symptoms:  chills and body aches (initiated 12 hours post injection.  Lasting for 8 hours) pain at the injection site (lasting at least 5 days post injection).  No interventions sought.    Breastfeeding Infant: Infant (39 days old at the time the vaccination was administered to the breastfeeding mother) who exclusively breastfeeds experienced emesis of breastmilk and stomach contents starting 12 hours post injection lasting for approximately 6 hours.  In addition, increased nasal secretions/mucous noted.   Symptoms resolved naturally without interventions
child had fever 103, lethargy, and stomach symptoms (nausea/vomiting)
Child received vaccine during school located vaccine event at approx. 9 A.M. School nurse notified clinic that child had vomited once by 1 P.M. Advised nurse to monitor student for any other symptoms, notify parents, and advise them to seek medical attention if needed. Vaccine information statement was given to child at time of vaccination to take home to parents. 3-10-23- Follow-up call made to home. Mother reported child has been fine, only experiencing a swollen arm at injection site. Mom denies any other symptoms and no more vomiting. Mom reported child had been experiencing allergy symptoms prior to vaccination including postnasal drip and she felt that is what caused her to vomit.
Reddened, hot and hard area the size of a softball. Cellulitis dx'd at Urgent Care.
Rash on my arms large bumps on my chest, short of breath, headaches, severe itching, nausea, flu like symptoms, minutes after shot burning sensation like my left side was on fire then it moved to right side of my chest. (I took pictures). I finally made it to doctor since Pharmacy is the one who gave me the shot RPH administer Flares Quad 2017-2018 on 08/13/2017.
redness of arm/ redness from the injection site and travelled down the arm to the wrist; arm felt warm; This case was reported by a other health professional via call center representative and described the occurrence of erythema of extremities in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included bee sting hypersensitivity and allergy to antibiotic.   On 6th November 2019, the patient received the 1st dose of Shingrix (intramuscular). On 6th November 2019, 8 hrs after receiving Shingrix, the patient experienced erythema of extremities and skin warm. On an unknown date, the outcome of the erythema of extremities and skin warm were recovered/resolved.   It was unknown if the reporter considered the erythema of extremities and skin warm to be related to Shingrix.  Additional information was provided as follows: The patient received Shingrix on the left arm. the patient experienced redness from the injection site and traveled down the arm to the wrist and also reported that the site felt warm. The events were resolved after 4 to 5 days. The reporter consented to follow up. The outcome of the events were reported in source document as recovered and resolved with sequel, however it was reported as recovered and resolved in System.
Initial report received from a consumer's grandmother on 04 October 2010. A 2 month old infant, with a history of pyloric stenosis, received on 16 April 2010 an injection (dose 1) of PENTACEL (invalid lot number C354AA reported) and an injection of Rotavirus, lot number not reported. The patient had no illness at the time of vaccination, no known allergies (NKA) and took no medications. On the 19 April 2010, the patient developed a rash and hives. On 21 April 2010, the patient developed a rash on the face and was nauseated. The patient was taken for surgery on 22 April 2010 for pyloric stenosis. The outcome was not reported. Follow-up information was received from a physician on 08 October 2010. The patient received the following vaccinations on 16 April 2010: a left thigh intramuscular (IM) injection (dose 1) of PENTACEL (lot number C3542AA), and an oral dose of ROTATEQ, (Merck, lot number 1440Y). The patient had previously received a dose of Hepatitis B vaccine at birth. One week after receiving his 2-month vaccinations, the patient developed facial rash and persistent vomiting. The patient was taken to the ED and admitted to the hospital on 20 April 2010 (previously reported as 22 April 2010) for pyloric stenosis surgery. The grandmother felt the events were caused by the vaccines and therefore, the patient did not receive any further vaccines until 6 months of age. The patient continued to have intermittent episodes of urticaria. Outcome was not reported. The patient had a second dose of PENTACEL on 26 August 2010 at 6 months of age and developed rash and hives which is captured in case 2010-05722. Documents held by sender: Medical records.
Site: Swelling at Injection Site-Mild, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Nausea-Mild
pt exp redness around inj site as well as erythema of cheeks, eyes & legs  15min p/vax;DPH given & observed for 30min;
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Headache-Mild, Additional Details: patient experienced lightheadness flushing and paramedics were called. blood pressure 114/88 and hr 76. patient responsive by the time ambulance came and was alert and oriented. patient rested and recovered. patient left clinic with mom and will follow up with pcp.
The following week on September 10th I was diagnosed with a break through case of Covid-19. Since then I have extended weakness, I am on oxygen, and my stamina continues to wain. I have had many tests with no specific cause for these symptoms to be continuing. They are going to have me try Pulmonary Rehab.
Aches and pains; this morning I went and I had a rapid COVID test and it says it tested positive; this morning I went and I had a rapid COVID test and it says it tested positive; still felt like had some flu; This is a spontaneous report from a contactable consumer or other non-HCP. A 59-years-old male patient received bnt162b2 (BNT162B2, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 11Apr2021 (Batch/Lot Number: ER8737) as SINGLE DOSE for covid-19 immunisation. The patient medical history was none. Concomitant medications included Aimovig sureclick 70 mg once every 30 days for migraine. Historical vaccine included BNT162B2 (Batch no. EN6208, expiry date Jun2021) on 24Mar2021 for Covid-19 Immunization. Patient stated that he received both doses of Pfizer vaccine shot and about week before of the second shot he started having a aches and pains like a mild flu on 01Apr2021 and so this last, so on Sunday he got the second dose and then still felt like had some flu, aches, and pains. The events were considered non serious. Patient received Tylenol, Every 4 hour twice a day as a treatment of the events. In morning on 13Apr2021, he went and had a rapid COVID test (RT PCR test) which tested positive which was considered serious as medically significant event. Patient had not yet recovered from the events aches and pains like a mild flu and outcome of event, this morning patient went and had a rapid COVID test and it says it tested positive was reported as unknown.