chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Large red, itchy, warm patch right below injection sight.; Large red, itchy, warm patch right below injection sight; Large red, itchy, warm patch right below injection sight; This is a spontaneous report from a contactable consumer (patient).  A 68-years-old patient of an unknown gender received second dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot Number: EN9581) administered in left arm via an unknown route of administration, on 14Feb2021 at 16:15 pm ((at the age of 68-years-old) as SINGLE DOSE for covid-19 immunization. Medical history included mixed connective tissue. The patient previously administered first dose of bnt162b2 (Lot number: EL1283) via unspecified route, administered in left arm on 24Jan2021 at 07:15am. There were no known allergies. Concomitant medications (other medications in two weeks) included Methotrexate, Hydroxychloroquine, Phenytoin, Prednisone. Prior to vaccination the patient was not tested for covid-19. Patient did not test COVID post vaccination. On 22Feb2021,  8 days after second dose, the patient experienced large red, itchy, warm patch right below injection sight about 3 inches in diameter. The patient did not receive any treatment for adverse events. The patient had no other vaccine in four weeks. The outcome of the events was unknown.
Information has been received from a registered pharmacist concerning a female patient who on 08-OCT-2008 was vaccinated with a dose of GARDASIL vaccine.  The registered pharmacist reported that on 09-OCT-2008, the patient developed a "full body rash" after receiving GARDASIL vaccine.  The patient sought medical attention at an office visit.  At the time of the report the patient had not recovered.  Additional information has been requested. This is in follow-up to report(s) previously submitted on 11/14/2008; 1/7/2009. Follow up information was received from a physician who stated that he remembered the patient but not her name or identification number: "At the time I saw her, her rash was totally normal and clear". He stated that he could not contribute any useful information about the event because he had never seen the rash at all. No further information is available.
Transverse myelitis, leg weakness, bladder/bowel dysfunction. Hospitalized, still recovering.
TIRED; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination.  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 01-APR-2021, the subject experienced tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of tired was not reported. This report was non-serious.
Rash become a darker red; Injection site get swollen; Injection site hot; Injection site itchy; Injection site sore; Injection site red rash; Possible drug interaction; This case was reported by a consumer via other and described the occurrence of injection site swelling in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included alirocumab (Praluent) for low density lipoprotein cholesterol.   Concurrent medical conditions included low density lipoprotein and cholesterol.   On 21st May 2019, the patient received the 1st dose of Shingrix. On 22nd April 2019, the patient started Praluent at an unknown dose and frequency. In July 2019, unknown after receiving Shingrix, the patient experienced drug interaction. On 16th July 2019, the patient experienced injection site swelling, injection site warmth, injection site itching, injection site pain and injection site rash. On 17th July 2019, the patient experienced red rash. On an unknown date, the outcome of the injection site swelling, injection site warmth, injection site itching, injection site pain, injection site rash and red rash were not recovered/not resolved and the outcome of the drug interaction was unknown.   It was unknown if the reporter considered the injection site swelling, injection site warmth, injection site itching, injection site pain, injection site rash and red rash to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient herself. The age at vaccination was not reported. On 22nd April 2019, the patient received 1st dose of Praluent for the treatment of her Low density lipoprotein (LDL) cholesterol. The patient was currently on Praluent 150 mg every 2 weeks. For the 1st two injections, the patient had no reactions at all for the 1st month. On 15th July 2019, the patient had most recent injection of Praluent after Shingrix administration and the patient started having problems at the injection site every time when she receive a Praluent injection, which led to possible drug interaction. On the 1st day after the Praluent shot, the injection site got swollen, hot, itchy, sore and developed a little light red rash. By the 2nd day after an Praluent injection, 57 days after the Shingrix administration, the rash become a darker red and increased to about 2 inches in diameter. It took about a week to go away. The patient had been injecting the Praluent in her thigh, due to reactions, she tried it on her arm the day before reporting and seemed to be developing the same reactions. It was unknown if the reporter considered the injection site swelling, injection site warmth, injection site itching, injection site pain, injection site rash and red rash to be related to Praluent, as well. No additional information was provided. For additional information, the reporter could be contacted directly.
Report 2001013714-1 described abdominal pain in a pt who rec'd hepatitis Be vaccine (recombinant)(Engerix-B). Allergies and concomitant medications were not specified. Per the pt's daughter the pt was having problems before in this area (liver). There was no illness at the tie of vaccination. Per the reporter, the pt denied any problems prior to the administration of Engerix-B and hepatitis A vaccine inactivated (Havrix). This report has been submitted by the reporter also to the center for disease control. On 3/25/01 at 15:30 the pt rec'd his first 20 mcg intra-muscular dose of Engerix-B, his first intra-muscular dose of Havrix, and a 0.5 cc intra-muscular dose of tetanus - diphtheria vaccine. 48 hrs following vaccination ,on 3/29/01, the pt complained of moderate pain in liver. This symptom was subsequently reported as abdominal pain right side under rib. 2 weeks later, the pt was seen by a physician. The pt had discomfort at this time. A CT scan, and a liver enzymes study on approx 4/13/01 were normal. No drugs were used to treat the adverse event. The abdominal pain resolved in 9 days, on 4/23/01. the reporting nurse stated that the abdominal pain was moderate in intensity and possibly related to Engerix-B. The physician recommended that the pt no continue with the follow-up vaccines. As of 6/20/01, the event resolved.
He received his vaccine, had soreness in his arm.  Went to bed and around 2:00 AM his brother got a call from his dad (he lives upstairs from him in the same house) who said that something was wrong and he needed to go to the hospital.  The brother found him  sweating profusely, it appeared that the right side of his body was stiffening up, and they started to go out to the car to go to the hospital.  He started to go limp and he collapsed and tried to revive him, they called 9-1-1 and they tried to revive him as well without success and he died.
42 year old female who works as a pharmacy tech developed diffuse pruritus and throat tightness, nausea during her wait time. She was given EPIPEN and transferred into the treatment area. She was given 50mg benadryl x2 followed by an additional EPIPEN. Patient reported throat tightness resolution but persistent pruritus and nausea. She was transferred to ED in stable condition with plans to follow up in Allergy.
Moderate Tinnitus 2 days after injection.  Migraine 6 days after.  Tinnitus is continuing and has not stopped after 12 days. Tinnitus is high pitched and constant Also had sore arm around injection site for 3 days
Nasal Swab Positive; This is a spontaneous report from a contactable other health professional (patient). A 58-Year-old non pregnant female patient received the BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL3249), via an unspecified route of administration on 22Jan2021 at 12:00 PM in the left arm as 1st dose, single for COVID-19 immunisation. Facility where COVID-19 vaccine was administered was workplace clinic. The patient medical history and concomitant medication were not reported. Prior and post vaccination, the patient was diagnosed with COVID-19. The patient experienced nasal swab positive on 25Jan2021. The patient underwent lab tests and procedures which included nasal swab: positive on 25Jan2021. Outcome of the event was unknown.
Mother reports child had chicken pox disease starting about February 26, 2005.  Light case 10 spots and no fever.  This is 10 days after twin sister became ill with chicken pox.
Patient states that the rash is very uncomfortable; Patient states that the rash is very uncomfortable and keeps him up at night; rash appears like measles and is located all over his arms, hips, chest, and back; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DISCOMFORT (Patient states that the rash is very uncomfortable), INSOMNIA (Patient states that the rash is very uncomfortable and keeps him up at night) and RASH (rash appears like measles and is located all over his arms, hips, chest, and back) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     Concurrent medical conditions included Seasonal allergy (Seasonal allergies). Concomitant products included FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for Seasonal allergy.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DISCOMFORT (Patient states that the rash is very uncomfortable), INSOMNIA (Patient states that the rash is very uncomfortable and keeps him up at night) and RASH (rash appears like measles and is located all over his arms, hips, chest, and back). The patient was treated with CORTISONE for Rash, at an unspecified dose and frequency. At the time of the report, DISCOMFORT (Patient states that the rash is very uncomfortable) and INSOMNIA (Patient states that the rash is very uncomfortable and keeps him up at night) outcome was unknown and RASH (rash appears like measles and is located all over his arms, hips, chest, and back) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Treatment medication included 5-day course of steroids.   This case was linked to MOD-2021-114619.
Approximately ten minutes after receiving the vaccine the patient came back to pharmacy stating that she felt dizzy. She sat down and then when asked how she felt she says she has a history of seizures and felt like she was about to have a seizure.  She complained of blurred vision, shortness of breath, tremor. EMS arrived shortly after to assist patient and take her to ER. Patient also stated she has history of diabetes.  She stated she checked blood sugar prior to arriving to pharmacy and said it was okay.
11 Hours later ambulance called Taken to hospital C/O of left  shoulder arm chest pain ,significant dizziness, unable to stand without falling over
Left arm pain  Benadryl, 1 tsp every 6 hours Motrin, 2 tsp every 6 hours
This spontaneous report as received from a physician refers to an unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with RECOMBIVAX HB dose 1. Route, dose and lot number were not provided. The physician reported that the patients failed to seroconvert after receiving RECOMBIVAX according to the appropriate dosing schedule. The physician mentioned he had been administering RECOMBIVAX for 20 years, and approximately 5-10% patients out of every 100 patients he estimated had negative titers after following the recommended vaccination schedule. The outcome of negative titer is unknown. Reporter causality assessment was not reported. Additional information has been requested.
Patient received COVID vaccine approximately one week prior to admission.  Patient developed acute rhabdomyolysis requiring hospitalization.  She developed pain and stiffness in her neck which spread to her back and generalized muscles to the point where she had difficulty moving in the next 12 hours.  She did not have difficulty swallowing but she did have difficulty chewing and complained of throat pain.  Upon arrival to the emergency room she was unable to lift her legs to get out of the car.  In the emergency room she was found to have a CK of 130,000 along with a creatinine of 1.1 and potassium of 6.8 with a calcium of 7.0.  She was admitted to the hospital ward and given aggressive IVFs. The following am she was having trouble breathing and was started on BIPAP; the repeat CK level climbed to 543,500.  She continued to worsen, developing increased swelling around the mouth and neck.  She became anuric with acute kidney injury; and was subsequently transferred to CCC upon which she was intubated and initiated on CRRT.
Right arm - right upper arm - red and swollen. Started 3/04/10 around 12:00pm. Area 16cm X 20 1/2 cm on upper right arm. Alternate ice and heat. Give BENADRYL - dose appropriate for wt. and MOTRIN
Red hive 6 inches long 4 inches wide around injection area hot to touch, kept growing until site above injection was at 5PM 08/15/2005, hive started next night.  Knot on hand at injection site still some discoloration with bruise appearance.
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a female of unspecified age, 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 admin, and batch number: Unknown and expiry: Unknown) dose was not reported, 1 total administered on APR-2021 for prophylactic vaccination. 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 experienced low grade fever, body ache and fatigue and tested positive for covid-19 (suspected covid-19 infection, suspected clinical vaccination failure). Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected clinical vaccination failure and suspected covid-19 infection was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint. Product quality number has been requested.; Sender's Comments: V0-20220146069-Covid-19 vaccine ad26.cov2.s-Suspected clinical vaccination failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
Initial information received on 13-Sep-2018 regarding an unsolicited valid non-serious case received from other health professional. This case involves a five months old male patient and reported that 5 months, received 0.25 ml of FLUZONE QUADRIVALENT. The patients past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. On 12-Sep-2018, the patient received a 0.25 ml dose of suspect FLUZONE QUADRIVALENT (lot number: UT6262MA and expiry date: 30-June-2019) (dose in series was not reported) via intramuscular route in the left thigh. This was the case of actual medication error due to inappropriate age at vaccine administration. No reported symptoms. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Information has been received from a registered nurse concerning a 7-year-old male on 29-JUL-1999 was vaccinated with a 0.5mL dose of Varivax (Lot # 630687/0443J). It was unknown if there was any illness at the time of vaccination. Concomitant therapy that day included a first 0.5cc dose (Lot # 631054/0374F) of MMR (second dose administered on 05-AUG-2007). Other therapy included: a first, second and fifth dose of diphtheria (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid on 09-SEP-1998, and 05-AUG-2002; a third and fourth 0.5cc dose of ACEL-IMUNE on 21-JAN-1999 (Lot # 457-790) and 26-OCT-1999 (Lot # 464305); a first and second dose of hepatitis B vaccine recomb on 24-JUL-1998 and 09-SEP-1998; a first and second dose of HIBTITER on 09-SEP-1998 and 19-NOV-1998; a fourth dose of HIBTITER (Batch # 423203A) on 26-OCT-1999; a third 0.5cc dose of COMVAX (Lot # 629303/1615H) on 21-JAN-2999; a 0.5mL dose of FLUZONE (Batch # U1172AA) on 15-DEC-2003; a first, second, and fourth dose of IPV on 09-SEP-1998, 19-NOV-1998, and 05-AUG-2002, a third 0.5cc dose of IPV (Batch # P0126) on 26-OCT-1999; and a dose of diphtheria toxoid/tetanus toxoid on 05-AUG-2002. On 02-MAY-2006 the patient experienced chickenpox. Unspecified medical attention was sought. Subsequently, the patient recovered from chicken pox. No additional information is expected.
lips swelled up; chewing on the inside of her cheeks; This spontaneous case was reported by a consumer and describes the occurrence of LIP SWELLING (lips swelled up) and BITE (chewing on the inside of her cheeks) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, the patient experienced LIP SWELLING (lips swelled up) and BITE (chewing on the inside of her cheeks). At the time of the report, LIP SWELLING (lips swelled up) and BITE (chewing on the inside of her cheeks) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No treatment information was provided.  No concomitant medication was provided.; 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.
rash; This spontaneous case was reported by an other health care professional and describes the occurrence of RASH (rash) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (rash). At the time of the report, RASH (rash) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported by the reporter. No treatment was reported by the reporter.
Pt complaining of fever, shakes and chills, 24 hours, post vax. Right arm is slightly red and tender at site. Treated with ice pack. Pt complaining of abdominal pain and 1 bout of vomiting while flying on plane on 3/12/2000. Pt seen on 3/13/2000, no fever and no vomiting, slight nausea with no vomiting. Call back if not better.
Vaccine administrered on 30-Nov-2021, placed in refrigerator on 27-Nov-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 administrered on 30-Nov-2021, placed in refrigerator on 27-Nov-2021) in a 28-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 30-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Nov-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 administrered on 30-Nov-2021, placed in refrigerator on 27-Nov-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine administrered on 30-Nov-2021, placed in refrigerator on 27-Nov-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.  HCP said that 606 doses were given after expiration date. HCP said that there was a confusion between the expiration date printed in the carton and the expiration date when the QR code was scanned.  On 27-Nov-2021, the vial was stored in the refrigerator. The vial did not undergo any temperature excursions and had no adverse event.
Information has been received from a physician concerning a 9 year old male who with not known medical history or allergies who on 01-OCT-1996 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). There was no concomitant medication. On 26-August-2005 the patient developed 75 chickenpox lesions on chest, back, and abdomen. The lesions were described by the physician as "some healed, some papular, some scaly and some vesicular". The physician said in the chart "questionable healing varicella". The patient was itchy with no fever. Unspecified medical attention was sought. No laboratory diagnostic tests were performed. At the time of this report the patient was recovering. Additional information has been requested.
24 hours post vax, the pt developed tenderness and erythema in left deltoid. He also developed vertigo symptoms and hypertension.
At 0905 hrs patient complained of feeling as if her BP dropped upon assessment her BP was 200/120, all other VS were WNL, at 0921 hrs her BP was 216/117, S1S2 were regular, breath sounds were clear throughout, no difficulty swallowing, no SOB or difficulty breathing, capillary refill less than 2 seconds, radial pulses equal and strong bilaterally. Patient stated felt fine with no complaints. At 0938 hrs BP was 190/135 all other VS WNL, at 0957 BP 181/120, at 1020 hrs BP 196/95, patient denied any pain and continued to state she felt fine. Advised patient to not continue her working shift and have a family member or friend pick her up from work and rest at home. Patient was picked up by a family friend and advised to follow up with PCP and seek medical attention if begins to feel adverse symptoms. Patient left ambulatory in stable condition with no complaints or symptoms.