chrisvoncsefalvay/vaers-outcomes huggingface dataset:
had a fever of 103.4F; Still ill; This is a spontaneous report from a contactable consumer (patient's mother). A 16-year-old male patient (reporter's son) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 2 via an unspecified route of administration administered in arm left on 24Jun2021 13:45 (Lot Number: EW0217) as dose 2, single (at age of 16-year-old) for covid-19 immunisation. Medical history included Celiac disease. The patient's concomitant medications were not reported. Historical Vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot: EW0197) administered in the Left Arm on 03Jun2021 for Covid-19 immunization. The patient experienced fever started around 23:00 on 24Jun2021. The patient had a fever of 103.4F and he was still ill after the second vaccine on 24Jun2021. The reporter asked when she can expect he will feel better and when she should take him to the doctor. The reporter was told by nurse that his temperature was normal. The patient had been treated his fever with medication, otherwise it went back, the reporter had to even give him a tepid bath. When medication wear off, the fever came back. Outcome of the events was not recovered.
This spontaneous report as received from a registered nurse refers to a patient of unknown age who on 24-APR-2013, was vaccinated with a dose of VAQTA (dose, route and lot number not reported) that was expired. No adverse effects were reported. Additional information has been requested.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. The reporter stated that, on an unspecified date, and unknown number of doses of LIQUID PEDVAXHIB (dose, lot#, expiration dates not provided) that were stored at 48 degrees F for 20 minutes, then exposed to 47 degrees for 9 minutes have been administered. No adverse effects were reported. Follow up information has been received on 22-JUL-2014 from a receptionist. The reporter stated there were two different lot numbers of LIQUID PEDVAXHIB that were included in the temperature excursion: Lot # J016188, expiration date: 02-OCT-2016 and lot # J015437, expiration date: 09-OCT-2016. The receptionist did not have any additional information to share. Follow-up information from the registered nurse who provided patients details. This report refers to a 7 month old infant patient of unknown gender. On 26-JUN-2014, the patient was vaccinated with a dose of LIQUID PEDVAXHIB (dose and route were not reported, lot# J016188, expiration date 02-OCT-2016) that was improperly stored. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected.
Rapid Heart rate and elevated BP 3/13 Rapid heart rate was 127 at Patient first 3/13 Highest BP was 160/92 3/13 fever 100.4  3/13
Worst cramps; Lots of spotting; Period was much heavier and more painful than usual; Period was much heavier and more painful than usual; This is a spontaneous report from a non-contactable consumer, the patient. A 27-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0169) via an unspecified route of administration in the left arm on 17Apr2021 at 13:45 (at the age of 27-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medications. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the right arm on 27Mar2021 at 15:00 (at the age of 27-year-old) as a single dose for COVID-19 immunisation. The patient previously received cefaclor (MANUFACTURER UNKNOWN) for an unspecified indication on an unknown date and experienced drug allergy. On 21Apr2021, the patient had period on time but it was much heavier and more painful than usual. A few days after it ended, on 01May2021, the patient woke up in the middle of the night with the worst cramps she had in her entire life with lots of spotting and cramps were worse than when she had on full period. Her cycle was very regular so this was incredibly unusual and concerning. At the time of the reporting she was still in a lot of pain 3 days after. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as the result of events. The clinical outcome of the events period was much heavier and more painful than usual was recovered on an unknown date in Apr2021; while that of worst cramps and lots of spotting were recovering at the time of the report.  No follow-up attempts are possible. No further information is expected.
Panic attacks, anxiety, fear of death, fever, discharge and excess bleeding, joint pain and swelling.
Had nausea and vomiting, wheezing, difficulty breathing. She had hives and skin turned red everywhere.
Dumbness of lips and face. Subsided in the evening of 12/30/2020, followed by headache, fatigue, and soreness at injection site. All symptoms lessened morning of 12/31/2020
Full body rash occurring 2 to 4 days after injection. Patient did no treat & clearing on its own.
Approx 20 minutes after injection, patient became itchy and broke out into a rash on her arms, back and legs.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 28-JAN-2013, the patient was vaccinated with live ZOSTAVAX (dose, route, site of administration and lot # not reported). The pharmacist reported that the patient took an unspecified antiviral about 4 hours before the patient was vaccinated with live ZOSTAVAX. There was no adverse event reported. Additional information has been requested.
numbness, tingling, cramping and pain in Left Index, middle and Ring Finger, Up Left Arm
Severe gastro distress, lower lip cancer, myocardial infarct and myocardial ischemia.
Got a red papule; This case was reported by a consumer via interactive digital media and described the occurrence of papule in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced papule. On an unknown date, the outcome of the papule was unknown.   It was unknown if the reporter considered the papule to be related to Shingrix.  Additional details were provided as follows: The age group was not reported, however it was captured as an adult as per vaccine indication. The age at vaccination was not reported. The patient got a red papule with the second Shingrix vaccine. The patient asked if this was normal.
15 minutes after receiving vaccine, client stated she had symptoms of "hayfever." Eyes itchy, nasal congestion, runny nose, headache, sore throat. Denies feeling of throat closing or SOB. Long history of allergies-esp tree nuts . Brought by wheelchair to med exam area: A&O x 3, BP 138/70, Chest: CTA, Cardio: RRR 85 bpm, eyes erythematous, RR 15. Given cold water and kept in med station for an hour. Declined transfer to local ED for further eval/tx. Stated she was improving, symptoms much better. Eyes appeared clear w/out erythema, eupneic, no SOB. States feeling much better. Client stated she was well enough to go home and asked to leave. She then left for home.
atypical shingles; rash right side of body; itching to the right side of the body; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of PRURITUS (itching to the right side of the body), RASH (rash right side of body) and HERPES ZOSTER (atypical shingles) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001C21A and 0C31321A) for COVID-19 vaccination.     no medical history information was reported.  Previously administered products included for Shingles: SHINGRIX in 2018. Concomitant products included LEVOTHYROXINE, ROSUVASTATIN and FLUOXETINE for an unknown indication.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 23-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PRURITUS (itching to the right side of the body). On 24-Apr-2021, the patient experienced RASH (rash right side of body). On 26-Apr-2021, the patient experienced HERPES ZOSTER (atypical shingles). The patient was treated with CORTISONE (topical) at a dose of 1 dosage form cream; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (topical) at a dose of 1 dosage form cream; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (oral) at a dose of 1 dosage form; ACYCLOVIR [ACICLOVIR] at a dose of 1 dosage form and PREGABALIN at a dose of 1 dosage form. On 05-May-2021, RASH (rash right side of body) and HERPES ZOSTER (atypical shingles) had resolved. At the time of the report, PRURITUS (itching to the right side of the body) outcome was unknown.            For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. the patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable.
Her fingers are cracking due to the cold weather; Her hands got dry due to the cold weather; Arm is still red; Arm is still swelled; Hurts like a son of a gun; This spontaneous case was reported by a consumer and describes the occurrence of SKIN FISSURES (Her fingers are cracking due to the cold weather), DRY SKIN (Her hands got dry due to the cold weather), VACCINATION SITE ERYTHEMA (Arm is still red), VACCINATION SITE SWELLING (Arm is still swelled) and VACCINATION SITE PAIN (Hurts like a son of a gun) 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.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. 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 SKIN FISSURES (Her fingers are cracking due to the cold weather), DRY SKIN (Her hands got dry due to the cold weather), VACCINATION SITE ERYTHEMA (Arm is still red), VACCINATION SITE SWELLING (Arm is still swelled) and VACCINATION SITE PAIN (Hurts like a son of a gun). At the time of the report, SKIN FISSURES (Her fingers are cracking due to the cold weather) and DRY SKIN (Her hands got dry due to the cold weather) outcome was unknown and VACCINATION SITE ERYTHEMA (Arm is still red), VACCINATION SITE SWELLING (Arm is still swelled) and VACCINATION SITE PAIN (Hurts like a son of a gun) had not resolved.            No relevant concomitant product were reported. No treatment medication was provided.  After getting booster dose, patient's arm was still red, still swelled and hurts like a son of a gun. Patient did not had a problem with first or second dose.
breakthrough case of Covid; breakthrough case of Covid; This is a spontaneous report from a contactable physician received via a Pfizer representative.   A patient of unspecified age and gender received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation.  The patient's medical history and concomitant medications were not reported.  The patient received the Pfizer vaccine and had a breakthrough case of Covid. Patient is alive and stable. The patient underwent lab tests and procedures which included sars-cov-2 test: positive un an unspecified date. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report as received from a company representative referring on a friends unspecified 15 month old male son. The patient's current conditions or medical history were not reported. On an unknown date, the patient was vaccinated with a dose of MMR II (dose, route, lot number and expiration date not reported). Concomitant therapies included Amoxicillin. On an unspecified date, 10 days after receiving MMR II, the patient developed a rash on his face, neck and back. The patient was given Prednisolone to treat the reaction by an unspecified physician. Outcome of rash on face, neck and back was unknown at the time of the report. Additional information has been requested.
Extreme chills, hot flashes, feverish without a temperature, small amount of vomit, nausea, confusion
This spontaneous report as received from a pharmacist refers to a 50 year old female patient with no drug reactions/allergies. On 05-NOV-2014, the patient was vaccinated with ZOSTAVAX (dose, route, frequency and lot number not provided) at her unspecified physician's office. On an unspecified date following vaccination in November 2014, the patient experienced redness, tenderness and a burning sensation at the injection site and tenderness at the injection site, injection site unspecified. The reporter stated that the patient denied any rash or lesions being present. The patient did not seek medical attention. The outcomes were reported as not recovered/not resolved. Additional information has been requested.
Pt received first COVID Pfizer vaccine on 3/2/21 and second vaccine dose of Pfizer on 3/23/21 and tested positive for COVID 3/24/21 was admitted through the ED on 3/24/21 with decreased oxygen levels (50%) and SOB. Admitted to the floor on 3/25/21, Patient was never intubated but was put on continuous BiPap. Patient treated with acetaminophine, albuterol, solumedrol, and remdesivir. Patient expired on 4/15/21. Cause of death was secondary COVID pneumonia and acute respiratory failure.
SLEEPY AFTER BOOSTER DOSE; SHE CAN NOT MOVE AND DO ANYTHING; PAIN IN SHOULDER, ARMS AND HANDS; TIRED AFTER BOOSTER DOSE; This spontaneous report received from a patient concerned a 74-year-old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient was healthy and did not took any medication. She never had any reactions to flu shot and never had a problem. The patient was previously treated with influenza vaccine (Flu shot) for prophylactic vaccination. The patient was previously received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of administration not reported, batch number: unknown and expiry: unknown) dose was not reported, 01 total administered on 06-APR-2021 for prophylactic vaccination. After receiving primary dose, she felt tremendous electricity going through her body and she was shocked (dose number in series 1). The sensation later disappeared and she did not mention it to the pharmacist at the vaccine facility. On 07-APR-2021, she was so tired and she could hardly get out of bed and slept more than usual (dose number in series 1). On an unspecified date, after few months she felt tired again but decided to get the booster dose (dose number in series 1). The patient additionally received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of administration not reported, batch number: unknown and expiry: unknown) dose was not reported, 01 total administered on 26-NOV-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, after getting the booster dose patient felt pain that started in shoulders and moved to hands. The patient stated pain was sometimes better but at times and she can not move and do anything (dose number in series 2). Her arm got better slowly but shoulder and hands was painful. On the day of report, her hands was painful and sore and pain seldom gone away. Left hand sometime got better but right hand was struck with pain. She was going to a chiropractor and got a little better. She felt tired and sleepy after the booster dose as well but not as much as the primary dose (dose number in series 2).  The action taken with covid-19 vaccine ad26.cov2.s was not applicable.  The patient had not recovered from pain in shoulder, arms and hands, and the outcome of tired after booster dose, sleepy after booster dose and she can not move and do anything was not reported (dose number in series 2). This report was non-serious. This case, involving the same patient is linked to 20220160873.
This patient had an adverse event that occurred 4 and 1/2 hours after receiving his second dose of Pfizer-Biotech vaccine on 9/11/2021. His mom called the pharmacy to report her son having a mild seizure. She said he has a history of seizures but has not had one in over a year until now.
Seizure; Acute kidney failure, unspecified; Hypo-osmolality and hyponatremia; Thrombocytopenia, unspecified
Stooled a lot like diarrhea after the PEDIARIX and got a shot, disturbed sleep. She stooled a lot like diarrhea after the PEDIARIX and got a diaper rash. Diaper rash. Disturbed sleep. No fever, more spit up more. Now that is gone.
Pediatric dose was given to adults mistakenly; Poor quality vaccine administered; Moderna COVID-19 vaccine administered to patients post temperature excursion; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered ), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patients post temperature excursion) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR5186C) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered ), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patients post temperature excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered ), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patients post temperature excursion) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered ) and PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patients post temperature excursion).    Concomitant product use was not provided by the reporter.  It was reported there was a temperature excursion between 26 May 2022 to 30 Sep 2022 and lot AR5186C was affected between 08 Sep 2022 to 27 Sep 2022. AR5186C was previously reported. Pediatric dose was given to adults mistakenly and were reported to CDPH, VAERS, CAIR and each patient that received the error dose, with instructions to re-vaccinate 2 months from the initial error dose. 051B22A was kept in the freezer upon receipt of shipment on 08-Jan-2022 and individual vials were put in the refrigerator on the day of use.  No treatment information was provided.  This case contains information for the 42 of 104 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-669791 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-669791:
Paxlovid: Treatment of COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 28-year-old male patient received BNT162b2 (BNT162B2), on 08Jan2021 at 04:00 as dose 1, single (Batch/Lot number: unknown), in right arm, on 25Jan2021 at 12:00 as dose 2, single (Batch/Lot number: unknown), in right arm and on 14Oct2021 at 03:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 27 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Epilepsy" (unspecified if ongoing). Concomitant medication(s) included: VIMPAT, start date: 11Aug2021; OXCARBAZEPINE, start date: 17Oct2019; ZONISAMIDE, start date: 15May2019. Past drug history included: Cefaclor, reaction(s): "Known allergy: Cefaclor".  The following information was reported: VACCINATION FAILURE (medically significant), outcome "unknown", described as "Paxlovid: Treatment of COVID-19"; COVID-19 (medically significant), outcome "unknown". The event "covid-19" required emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08May2022) positive; (15May2022) negative; (18May2022) positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: The patient tested positive for COVID-19 on Sunday, 08May and was treated with Paxlovid on Monday, 09May. Patient tested negative for covid on Sunday, 15May, and then positive on Wednesday 18May.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information available and close temporal association, a possible contributory role of the suspect Product cannot be excluded for the reported events . The case will be reassessed once new information is available.
Sneezing, sore throat, fever, racing heart, earache, runny nose, sore arm, extreme fatigue, headache
redness; swelling; This case was reported by a consumer via call center representative and described the occurrence of erythema in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced erythema and swelling. On an unknown date, the outcome of the erythema and swelling were unknown.   It was unknown if the reporter considered the erythema and swelling to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but was selected as an adult as per vaccine indication.  The patient experienced redness and swelling after receiving Shingrix. .
Within 24 hours I was feeling a leg cramping in my lower left calf, similar to when you have sat on an airplane too long. By the early hours of Sunday morning,  it had "spread" in my legs to upper legs and both legs. The pain increased to excruciating, and continued overnight through Monday. During that overnight, I was caring for my elderly mother. I assisted her to the bathroom per usual for the past 2 years. After the 3rd and final assist for the night, I felt lower back pain. That also increased and continues to be causing significant pain. The pain in my legs is gone.