chrisvoncsefalvay/vaers-outcomes huggingface dataset:
swollen/inflammation on hand started12 Feb 2021; headache started 12 Feb 2021; arms left and right so much pain felt like snake bite -11 Feb 2021; This spontaneous case was reported by a consumer and describes the occurrence of INFLAMMATION (swollen/inflammation on hand started12 Feb 2021), PAIN IN EXTREMITY (arms left and right so much pain felt like snake bite -11 Feb 2021) and HEADACHE (headache started 12 Feb 2021) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced PAIN IN EXTREMITY (arms left and right so much pain felt like snake bite -11 Feb 2021). On 12-Feb-2021, the patient experienced INFLAMMATION (swollen/inflammation on hand started12 Feb 2021) and HEADACHE (headache started 12 Feb 2021). At the time of the report, INFLAMMATION (swollen/inflammation on hand started12 Feb 2021), PAIN IN EXTREMITY (arms left and right so much pain felt like snake bite -11 Feb 2021) and HEADACHE (headache started 12 Feb 2021) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were provided. No treatment medication were provided.
This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 21-day-old female patient who received HAVRIX pediatric. On an unknown date, the patient received HAVRIX pediatric at an unknown dose. On an unknown date, an unknown time after receiving HAVRIX pediatric, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown. Additional details were provided as follows: The patient inadvertently received a paediatric dose of HAVRIX at an age of 21 days, which led to an inappropriate age at vaccine administration. The healthcare professional did not have product or patient information. Follow up information was received from nurse on 18th October 2016: The medication error was not done at the reporter's facility, so she did not have information on the product. An employee at a physician's office called to ask what she should do. The nurse told her to ask the doctor and call the medical department at GlaxoSmithKline. The patient's mother stated that the patient was fussy after vaccination, but no fever, redness or swelling occurred. The VAERS details were updated.
Redness, swelling and itching on right deltoid after immunization. Tender to touch. No discharge or blood noted. Took: Clindamycin.
Shortly after administration of vaccination patient started to develop hoarseness of voice with associated coughing as well as the sensation of her throat closing up.  Patient then developed dry heaves.
Case PHEH2016US025263 is an initial spontaneous report received from consumer on 30 Sep 2016. This report refers to female patient of unknown age. Medical history and concomitant medication was not reported. The patient was vaccinated with FLUVIRIN (batch number and expiry date not reported) intramuscularly on 11 Nov 2015. On 30 Nov 2015, the patient had Parsonage Turner Syndrome. The outcome of event was reported as condition improving. The seriousness of the event was reported as disability. The causality of the event was not reported. This case was lost to follow up.
Chills began at 11:00 pm, followed by fever, headache and body aches.  this continued for over 48 hours.  I could not eat and it was difficult to drink anything.
skin on both feet has been peeling; skin on the insides of both hands, up to the top of the hand, is really dry and skin is peeling; skin on the insides of both hands, up to the top of the hand, is really dry and skin is peeling; This spontaneous case was reported by a consumer and describes the occurrence of SKIN EXFOLIATION (skin on both feet has been peeling), SKIN EXFOLIATION (skin on the insides of both hands, up to the top of the hand, is really dry and skin is peeling) and DRY SKIN (skin on the insides of both hands, up to the top of the hand, is really dry and skin is peeling) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis. Concomitant products included ACETAMINOPHEN for Arthritis.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Apr-2021, the patient experienced SKIN EXFOLIATION (skin on the insides of both hands, up to the top of the hand, is really dry and skin is peeling) and DRY SKIN (skin on the insides of both hands, up to the top of the hand, is really dry and skin is peeling). On an unknown date, the patient experienced SKIN EXFOLIATION (skin on both feet has been peeling). At the time of the report, SKIN EXFOLIATION (skin on both feet has been peeling) had not resolved and SKIN EXFOLIATION (skin on the insides of both hands, up to the top of the hand, is really dry and skin is peeling) and DRY SKIN (skin on the insides of both hands, up to the top of the hand, is really dry and skin is peeling) had resolved.            Treatment provided include Suave lotion.   Most recent FOLLOW-UP information incorporated above includes: On 02-Jun-2021: Additional adverse event and event outcome were updated.
A physician reported the occurrence of an injection site reaction in a 6-month-old male who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine (Infanrix) for prophylaxis. The pt's medical history, concurrent conditions and concurrent medications were not reported. On an unspecified date, the pt received an injection of Infanrix; it was not known if he had received previous doses of Infanrix. In August 2001 he experienced an injection site reaction characterized by induration, erythema and swelling. He was seen in the ER. As of 08/07/2002 the outcomes of the injection site reaction was unknown.
Lump under left arm size of lima bean. Patient still sore at site of injection. The lump has gone away.
SUSPECTED COVID-19 INFECTION; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; OFF LABEL DOSING FREQUENCY; This spontaneous report received from a patient via other manufacturer (Pfizer) concerned a 62 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: allergy. The patient was previously treated with Pfizer BionTech (tozinameran) (Dose number in series 1) (form of admin, route of admin were not reported, batch number:1805020 expiry: UNKNOWN) dose was not reported, administered on 18-MAR-2021 for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination with Pfizer BionTech (tozinameran) (Dose number in series 1). The patient was previously treated with covid-19 vaccine ad26. cov2. s (Dose number in series 2) (suspension for injection, route of admin not reported, batch number: 1805020 expiry: UNKNOWN) dose was not reported, 1 total administered on 13-MAY-2021 for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination with covid-19 vaccine ad26. cov2. s (Dose number in series 2). The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 3) (suspension for injection, route of admin not reported, batch number: 1822809 expiry: UNKNOWN) dose was not reported, 1 total administered on 23-OCT-2021 for covid-19 prophylaxis which was associated with off label dosing frequency. The product was associated with Off label use (Dose number in series 3). Age at time of vaccination 62 years old. No concomitant medications were reported.  The patient also received non-company suspect vaccine Moderna (elasomeran) (Dose number in series 4) (form of admin, route of admin were not reported, batch number: 016J21-2A expiry: UNKNOWN) dose was not reported, administered on 01-APR-2022 for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination with Moderna (elasomeran) (Dose number in series 4). The patient additionaly received non-company suspect vaccine Moderna (elasomeran) (Dose number in series 5) (form of admin, route of admin were not reported, batch number: AS7162B expiry: UNKNOWN) dose was not reported, administered on 22-SEP-2022 for covid-19 prophylaxis which was revaccination with different covid-19 vaccine (Dose number in series 5).  On an unspecified date in 2023, the patient experienced suspected covid-19 infection (Dose number in series 5) for which the patient was treated with non-company suspect drug Paxlovid (nirmatrelvir/ritonavir) (form of admin, route of admin, batch number and expiry date were not reported) dose and frequency were not reported from 05-APR-2023 to 09-APR-2023 for covid-19 treatment.  On 15-APR-2023, the patient experienced rebound covid after paxlovid (Dose number in series 5). The action taken with covid-19 vaccine ad26.cov2.s, elasomeran, and elasomeran was not applicable; and action taken with nirmatrelvir/ritonavir was not reported. The outcome of the suspected covid-19 infection, off label dosing frequency and revaccination with different covid-19 vaccine was not reported. This report was non-serious.
Patient received the first dose of the covid vaccine on 12/30, and today 1/10/21  my arm has been itchy and I now have a round ring like rash on my arm near the injection site
scaiing and itcing on legs/ torso. dermatology prescribed non-streriod topical. scaling appaers to be clearinf but itching still persist.
PATIENT RECEIVED ADACEL AND PPD (TUBERSOL) ON 6-22-07.  ON 6/25/07,REPORTED LEFT UPPER ARM SWELLING, ERYTHEMIA, MILD BLISTERING AND INDURATION AT INJECTION SITE.  ERYTHEMIA 50MM X 40MM. SWELLING MODERATE, VISIBLE THROUGH SHIRT SLEEVE.   USED OCCASIONAL TYLENOL DURING WEEKEND.  ADVISED TO USE ADVIL Q 4-6 HOURS AND ICE PACKS TO UPPER LEFT ARM 10 MIN ON AND 10 MIN OFF REPEATEDLY DURING DAY (MINIMUM 10-12 TIMES) AND TO REPORT STATUS ON 6/26/07. ON 6/26/07, PATIENT CALLED, REPORTING CONTINUED PAIN BUT SLIGHT IMPROVEMENT OF ERYTHEMIA.  ADVISED TO CONTACT PHYSICIAN FOR FURTHER ADVICE AND TO REPORT IF NO FURTHER IMPROVEMENT AT INJECTION SITE.
Severe and excruciating pain in left arm and shoulder weakness and nerve damage and pain in left arm. Diagnosed with Parsonage Turner's Syndrome due to flu shot received on 9/27/17.
DEATH; PULMONARY EMBOLISM; DEEP VEIN THROMBOSIS; This spontaneous report received from a health care professional via a Regulatory Authority Vaccine Adverse Event Reporting System (VAERS) (VAERS ID 1731745) concerned a 88 year old female of unspecified race and ethnic origin. 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 administration not reported, batch number: unknown and expiry: unknown) dose was not reported, 1 total, administered on 19-JUN-2021 for an unknown indication. 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 16-JUL-2021, the patient had deep vein thrombosis (blood clot in leg) and pulmonary embolism (bilateral blood clots in the lungs). On an unspecified date, the patient was hospitalized for events. Number of days hospitalized and discharge information was not reported. On 31-JUL-2021, the patient died from deep vein thrombosis and pulmonary embolism (thromboembolism). It was unknown if an autopsy was performed. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient died from deep vein thrombosis and pulmonary embolism (thromboembolism) on 31-JUL-2021. This report was serious (Death, and Hospitalization Caused / Prolonged). This case, involving the same patient is linked to 20211016947.  Additional information was received from health care professional on 08-Oct-2021. Following receipt of additional information, it was determined that nullification and deletion was required for Manufacturer Report Number 20211016947. The information indicated that Manufacturer Report Number 20211016947 had E2B submission failure, due to incorrect format of VAERS ID. Therefore, this case was created to correct VAERS ID format. All relevant information will be submitted under Manufacturer Report Number 20211027314.; Sender's Comments: V0: Additional information was received from health care professional on 08-Oct-2021. The information indicated that Manufacturer Report Number 20211016947 had E2B submission failure, due to incorrect format of VAERS ID. Therefore, this case was created to correct VAERS ID format. 20211027314- Covid-19 vaccine ad26.cov2.s- Death, deep vein thrombosis and pulmonary embolism. 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: DEEP VEIN THROMBOSIS; PULMONARY EMBOLISM
Information was received on 29-JUN-2017 from a nurse who reported that a patient (age and gender not reported) was administered an expired M-M-R II (lot# L023386, expiration 25-JUN-2017) on 28-JUN-2017. No adverse effects were reported. No further information provided.  Additional information has been requested.
Felt sick (head cold) 12/8/22 - tested negative. Felt worse the following day: nasal congestion, cough, muscle ache - tested positive. Contacted my doctor and he prescribed Paxlovid. Began taking 12/10. Began feeling better 12/12. Continued Paxlovid through 12/14. Tested negative 12/17.  Felt good for 2 days. Began feeling achy, sinus congestion, cough 12/19. Tested positive that night. Contacted my physician the next day. He said to treat with OTC meds as needed. Presently taking Clairitin for nasal congestion.
Morning after vaccination patient complained of severe headache and dizziness Mom stated she became lethargic just stared and passed out briefly. Patient taken to ED. Advised to follow-up with neurologist. Patient complained of dizziness for 2-3 days following vaccine.
pt's case manager reported that pt feeling light headed. She can't walk back to her room after vaccination. She sat for about 30 minutes and felt a little better. She went to her room and took a nap. Felt better after the nap. Report soreness, red, and hard lump below the injection site for a couple days.
A rash appeared on right arm at the injection site. It is red, warm to the touch, and itchy... sore to the touch. My arm was sore for a few days right after the vaccine, but no rash. The rash began one week from time of vaccination.
Pfizer Dose 1 8/29/2021 (FC3181) Pfizer Dose 2 9/19/21 (FE3592) COVID Positive 1/12/22  1/12/22: 75 yr old male patient  with h/o DM-2, HTN, COPD, chronic bronchitis has received both of his doses of vaccine for SARS-CoV-2 virus.  Patient has been complaining of shortness of breath for the last 1 week and not feeling too well.  Patient's girlfriend uses oxygen all the time and has a pulse oximeter at home.  When the patient checked his pulse ox about 2 nights ago he noticed it was at 84% and used her oxygen via NC. Since he was short of breath, he wanted get himself tested for COVID-19 infection came to the facility where he was directed immediately to the emergency room for further evaluation.  On arrival to the emergency room, the patient was noted to have a pulse ox of 91% on room air but extremely short of breath.  Patient was given a breathing treatment with the dose of Solu-Medrol and antibiotics for treating his right lower lobe pneumonia.  Patient has been admitted for further care.   Patient denies any fever/chills/chest pain.  He has his shortness of breath is a little bit more than usual during ambulation.  He has had chronic bronchitis associated with sputum production for several years which is not worsened. He has no complaints of any abdominal pain, nausea or vomiting.  A SARs COVID test has been checked in the emergency room and the results are pending.  1/14/22: Acute on chronic respiratory failure  -due to COPD exacerbation and COVID  -reviewed the chest x-ray showing evidence of right basilar pneumonia  -rule out any aspiration, speech therapy to evaluate the patient  -pt receiving oxygen supplementation  -patient's SARS-CoV-2 test is pending  -patient also has associated chronic bronchitis  -check sputum   COPD exacerbation  -patient will be given albuterol MDI in the setting of COVID to avoid aerosolizing agents  -patient started on steroids  -patient is started on doxycycline   COVID pneumonia  -Remdesivir  -Decadron  -O2 sat goal >92%; encourage proning   Type 2 diabetes  -HbA1c 7.8%  -patient will continue taking his 40 units of Lantus at bedtime along with 4 units of Humalog with each meal; dc'ed on home meds  -hold patient's metformin   Hypertension  -patient will continue taking his home dose of Norvasc, lisinopril  -patient's hydrochlorothiazide will be held during hospital stay
FEEL HOT, NUMB ALL OVER, SHAKING. BP 124/95, HR 100-110. EMS CAME, OFFERED GATORADE, SX STILL PERSISTS, TRANSPORTED TO HOSPITAL
Immediate severe pain when injected into upper arm muscle. Difficulty using left arm since then with certain movements due to nerve pain. Hasn't improved as of today.
Flu like symptoms; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 08-Sep-2021 and was forwarded to Moderna on 08-Sep-2021.    This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms) in a  patient of an unknown age and gender 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms) outcome was unknown.            No concomitant medications reported.  No treatment information was reported by reporter.
Slight swelling & redness dev Fri after vaccine. Increased swelling & soreness Sat & Sun.
Swelling, redness, itching at left arm (subcutaneous) injection site, per pt of PNEUMOVAX 23 vaccine.
Hot at the site; Itchy at the site; Rash at the site; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE WARMTH (Hot at the site), VACCINATION SITE PRURITUS (Itchy at the site) and VACCINATION SITE RASH (Rash at the site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Hot at the site), VACCINATION SITE PRURITUS (Itchy at the site) and VACCINATION SITE RASH (Rash at the site). At the time of the report, VACCINATION SITE WARMTH (Hot at the site), VACCINATION SITE PRURITUS (Itchy at the site) and VACCINATION SITE RASH (Rash at the site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Reporter did not allow further contact
High fever 102 degrees. I just rested, drank lots of fluids and within a day it was gone.
Sore throat; Headache; Hot flashes; Muscle aches; This is a spontaneous report from a non-contactable consumer, the patient. A 26-year-old patient of an unknown gender received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EVE 0153) via an unspecified route of administration in the left arm on 13Apr2021 at 10:45 (at the age of 26-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma, and blood pressure high. Patient had no known allergies. Patient did not receive other medications in two weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 14Apr2021 at 14:30, the patient experienced sore throat, headache, hot flashes, muscle aches. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events sore throat, headache, hot flashes, muscle aches was not recovered.  No follow-up attempts are possible. No further information is expected.
Woke up to severe uncontrolled shivering that lasted about two hours, my right and left metal hip implants became very painful and hurt more when I tried to weight bear, Muscle cramps in left leg, fever and headache.It was the shivering that was the worst, almost like my body was in mild shock.
I started to experience symptoms of a sore throat, congested nose, sneezing and constant coughing on 11/22/2022. I tested on 11/24/2022 and then went to urgent care to confirm the positive result. I was given a prescription for PAXLOVID which helped tremendously. I did still feel fatigued for about two weeks after testing positive.
Received FLUZONE 1/15/09.  1 week later noted pain in both forearms & later both legs.   1/22/09 Mainly myalgias.  Still being evaluaated.
This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with a dose of GARDASIL (dose, lot# and expiration date not reported) that was exposed to 20 F for an unspecified period of time, which was excursion that was unsupported by in-house stability data. No adverse symptoms were reported. Follow up information has been received on 24-APR-2014 from a nurse. The reporter mentioned that "30 patients or less" received improperly stored GARDASIL that was to 20F for 11 days. Administration dates, lot # and expiration dates were not reported. Follow up information was received a health center manager. The patients' identifiers were obtained. This report concerns one of the patients. On 07-MAR-2014, the 19 year old (reported as 20 year old) female patient was vaccinated with the first dose of GARDASIL (lot # H020848, exp. 03-APR-2015) into left deltoid (dose, route not reported). The medication refrigerator was out of range on the following dates: Jan 07, temperature (Degrees Fahrenheit) 44/26; Jan 09, 36/22; Jan 11, 26/40; Jan 14, 22/26; Jan 16, 26; Jan 20, 28/32; Jan 25, 22; Jan 27, 24/26; Jan 28, 20/20; Feb 17, 26/20. This is one of several reports received from the same source. Additional information is not expected.
Rash consistent with generalized vaccinia (contagious rash, fever, rash on chest, trunk, and upper arms).
1 of 2 pts who exp a localized reaction following immun; pt devel several 3-4 cm bullous eruptions, erythema & swelling; required ER/MD visit; last immun was given in 1986 or 1987;