chrisvoncsefalvay/vaers-outcomes huggingface dataset:
itchiness at injection site; redness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (itchiness at injection site) and VACCINATION SITE ERYTHEMA (redness at injection site) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003A21A and 011M20A) for COVID-19 vaccination.     Concomitant products included TELMISARTAN, AMLODIPINE and ATORVASTATIN for an unknown indication.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (itchiness at injection site) and VACCINATION SITE ERYTHEMA (redness at injection site). At the time of the report, VACCINATION SITE PRURITUS (itchiness at injection site) and VACCINATION SITE ERYTHEMA (redness at injection site) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Updated event outcome and further FU was refused
cannot hold anything down her stomach/ what she did eat came back up; bad headaches; bad aches; This is a spontaneous report from a contactable consumer (patient). A 29-years-old female patient started to receive the 1st dose BNT162B2 (PFIZER-BIONTECH COVID-19, lot number: EH9899), via an unspecified route of administration at right arm muscle on 12Jan2021 in the morning about 9:30AM or 10:00AM at single dose for COVID-19 immunization. Medical history was reported as none. The patient's concomitant medications were not reported. The patient had not had a vaccine before vaccination. The patient was experiencing bad aches in Jan2021, bad headaches started 15Jan2021 about 17:30, Friday evening when she got off work and cannot hold anything down her stomach when she got up about 8:00 on 16Jan2021. What could she take to settle her stomach. She didn't each much at all, but what she did eat came back up. She was scared to eat something at the moment. She was just lost. She went to the Emergency Room on 16Jan2021, but it was a long wait so she went home. The outcome of events bad headaches and cannot hold anything down stomach was not recovered, of the other event was unknown. She wanted to know what she should take for these side effects and if the 2nd dose was optional. She wanted to know if she would feel better after the 2nd dose of the vaccine. She also wants to know if it was possible for her kids to get the virus if she was having the side effects, how long does the Pfizer-BioNTech Covid-19 Vaccine remain in the system. It was not reported as serious.
Information has been received from a healthcare worker refers to a child of unknown age and gender. On 29-JAN-2015 the subject was vaccinated with a dose of VAQTA (lot# unspecified), injection, strength was reported as 25/0.5 (unit unspecified) (dose, frequency and route were unspecified). The reporter reported that the subject was inadvertently administered an adult dose instead of a pediatric dose. No adverse effect was reported. Additional information has been requested.
Vaccine Given during a Well-check on 5/11/07. parents brought child to the ER on 5/13/07 for a persistant rash. ER contacted the office for a follow up at 8:30 on 5/14. rash was described as an erythematous raised rash on trunk and extremities with swelling around ears and eyes. Rash started at injection site. Rash in office - pin point papular, pustular rash on entire body with swollen upper eyelids and ears.
Depression, horrible pain and lumps under my armpits that extended throughout my body, who knows what the long term will be, I still feel it.
First influenza vaccine ever received. Symptoms started the day after vaccination. Swelling, pain, tenderness in left axilla and left testicle. No redness. No immobility of left arm. Treatment: ice to left testicle/groin QPM x 2 days with improvement/decreased sensitivity. Both areas still swollen and tender, but improving daily.
Large red, warm swollen patches BELOW the injection site.  It goes from side to side on the outside of the arm.
patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 42-year-old male patient 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  It was reported that there had been no power outages that would have impacted the Moderna vaccine. However, the Healthcare professional reiterates that because her facility was unable to download the digital data logger, they would need to treat this issue as a temperature excursion. The data logger was unable to download for the months of Dec-2021, Jan-2022, and Feb-2022. They were filling out a temperature excursion assessment at this time. It was reported that no adverse reactions were reported by any patients.  No treatment medication was provided.
FEVER (high of 102) x 3 DAYS, GENERALIZED MAILSE, BODY ACHES, CHILLS, HEADACHE, DIZZINESS FOR 4 DAYS
Atrial Fibrillation; This spontaneous case was reported by a consumer and describes the occurrence of ATRIAL FIBRILLATION (Atrial Fibrillation) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003B21A and 016M20A) for COVID-19 vaccination.     The patient's past medical history included Shortness of breath. Concurrent medical conditions included COPD (treated with prednisone) and Heart disorder. Concomitant products included PREDNISONE for COPD, BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT) and ALBUTEROL [SALBUTAMOL] for an unknown indication.   On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Feb-2021, the patient experienced ATRIAL FIBRILLATION (Atrial Fibrillation) (seriousness criterion medically significant). The patient was treated with DILTIAZEM for Atrial fibrillation, at an unspecified dose and frequency; APIXABAN (ELIQUIS) at an unspecified dose and frequency; LISINOPRIL at an unspecified dose and frequency and OXYGEN at a dose of 1 liter. On 22-Feb-2021, ATRIAL FIBRILLATION (Atrial Fibrillation) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medication included unknown medication that starts with the letter "T".  The action taken for m-RNA-1273 Covid-19 Moderna Vaccine was not applicable.  This case concerns a 84-year-old male with a serious unexpected event of atrial fibrillation. Event latency 2 days after first dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   This case was linked to MOD-2021-238713 (Patient Link).; Sender's Comments: This case concerns a 84-year-old male with a serious unexpected event of atrial fibrillation. Event latency 2 days after first dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Information has been received from a licensed practical nurse referring to multiple unspecified patients of unknown age and gender. On an unknown date the patients were vaccinated with doses of GARDASIL 9 (lot # L043213, expiration date: 28-AUG-2017; route not reported) that were improperly stored (0.6 degree C for 11 hours and 10 minutes and 12.3 degree C for 50 minutes; data logger). No adverse effects were reported. This is the several reports from the same reporter. Additional information has been requested.
Information has been received from a nurse referring to unspecified patients of unknown age and gender. The patients' concurrent condition and medical history were not reported. The concomitant therapy included sterile diluent (manufacturer unknown). Since 22-MAY-2017 to 23-AUG-2017, the patients administered improperly stored doses of RECOMBIVAX HB (dose, frequency and route were unknown, lot # L048848, expiration date: 09-AUG-2018) for prophylaxis. The temperature excursion was at 9 Celsius Degree to 25 Celsius Degree for 4.5 hours. There was no previous temperature excursion. Data logger involved. No adverse effects were reported in any patients. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA006062: US-009507513-1709USA006064: US-009507513-1708USA010866: US-009507513-1709USA006063.
Case number PHEH2016US029224, is a spontaneous report initially received from nurse on 04 Nov 2016. This report refers to 31 year old female patient. Medical history and concomitant medications were not reported. This breast feeding patient was inadvertently vaccinated with a single dose of FLUCELVAX Quadrivalent (batch number: not reported) at a dose of 0.5 ml intramuscular on 06 Oct 2016. No adverse event was reported following this administration error (exposure during breast feeding). The nurse assessed the case as non serious. Follow up report received from a healthcare professional on 07 Nov 2016: Updated birthdate of patient (previously reported as 28 Jul 1985 was changed to 12 Jul 1985).
Spurting fluid from injection site; Spurting fluid from injection site; A spontaneous report was received from a paramedic concerning a 30-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced spurting fluid from injection site.  The patient's medical history was not provided. No concomitant medications were not reported.  On 28 Dec 2020, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.   On 28 Dec 2020, upon vaccine administration and removal of the needle, the patient experienced spurting fluid from injection site. An amount of fluid, similar to the amount of vaccine administered, was released from the patient's deltoid. It was reported this has often occured to the patient when she receives the flu vaccine. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome for the event, spurting fluid from injection site, was considered resolved on 28 Dec 2020.; Reporter's Comments: This case concerns a 30-years-old, female subject, who experienced a non-serious unexpected event of injection site extravasation and incorrect dose administered for mRNA-1273, lot # unknown. There were no reported AEs associated with this case of injection site extravasation and incorrect dose administered.
chills; extreme itching at the injection site; systemic itching throughout her whole body; A spontaneous report was received from a pharmacist concerning a 60-year-old, female patient who was participating in the mRNA-1273 trial and who experienced extreme itching at the injection site, systemic itching throughout her whole body and chills.    The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   The patient received their first of two planned doses of mRNA-1273 on 23-Dec-2020 intramuscularly for prophylaxis of COVID-19 infection.   Patient received her Moderna vaccine on 23-Dec-2020 and stated that she has had bad side effects continuously since then.  On 30-Dec-2020, she reported that she had extreme itching at the injection site as well as systemic itching.  She denied hives. Approximately 02-Jan-2021, patient endorsed on and off chills.   Patient reported having had two Covid-19 tests, one on 28-Dec-2020 ordered by her workplace and the other one on 31-Dec-2020 ordered by her primary physician, both of which were negative.  She stated that on 31-Dec-2020, she also had a flu test that was negative.    Patient admitted to taking diphenhydramine to help alleviate itching.  She wished to know if these side effects were normal.    Treatment for the event included diphenhydramine for itching.   Action taken with mRNA-1273 in response to the events, extreme itching at the injection site, systemic itching throughout her whole body and chills, was not provided.   The outcome of the events, extreme itching at the injection site, systemic itching throughout her whole body and chills, was not reported.  The reporter did not provide a causality assessment for the events, extreme itching at the injection site, systemic itching throughout her whole body and chills; Reporter'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.
1/22/2021, 06:30 AM: Felt feverish, temp 98.4, sweating profusely, headache 1/22/2021, 08:00 AM: headache resolved without medication use  1/22/2021, 14:00 PM: No longer felt feverish, temp 97.8
Can't swallow; Her tongue is dry; Her lips are cracked; Can't sleep at night because her tongue is dry/keeps up 6-8 times at night; Burning sensation; Big red tongue; Dehydration; Lost a lot of weight; Dry mouth bothers her especially in the morning; Caused her to lose her taste of food; Big, fat, red, swollen tongue is from the COVID19 virus; This spontaneous case was reported by a consumer and describes the occurrence of DYSPHAGIA (Can't swallow), TONGUE DRY (Her tongue is dry), CHAPPED LIPS (Her lips are cracked), SLEEP DISORDER (Can't sleep at night because her tongue is dry/keeps up 6-8 times at night) and BURNING SENSATION (Burning sensation) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007B21A and 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-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 experienced DYSPHAGIA (Can't swallow), TONGUE DRY (Her tongue is dry), CHAPPED LIPS (Her lips are cracked), SLEEP DISORDER (Can't sleep at night because her tongue is dry/keeps up 6-8 times at night), BURNING SENSATION (Burning sensation), TONGUE ERYTHEMA (Big red tongue), DEHYDRATION (Dehydration), WEIGHT DECREASED (Lost a lot of weight), DRY MOUTH (Dry mouth bothers her especially in the morning), AGEUSIA (Caused her to lose her taste of food) and TONGUE OEDEMA (Big, fat, red, swollen tongue is from the COVID19 virus). At the time of the report, DYSPHAGIA (Can't swallow), TONGUE DRY (Her tongue is dry), CHAPPED LIPS (Her lips are cracked), SLEEP DISORDER (Can't sleep at night because her tongue is dry/keeps up 6-8 times at night), BURNING SENSATION (Burning sensation), TONGUE ERYTHEMA (Big red tongue), DEHYDRATION (Dehydration), WEIGHT DECREASED (Lost a lot of weight), DRY MOUTH (Dry mouth bothers her especially in the morning), AGEUSIA (Caused her to lose her taste of food) and TONGUE OEDEMA (Big, fat, red, swollen tongue is from the COVID19 virus) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: normal (normal) Normal.         Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.  Company comment: Considering current available information and plausible temporal relationship between product use and onset date of the event, causal role cannot be excluded. Other possible confounder is patient's advanced age.; Sender's Comments: Considering current available information and plausible temporal relationship between product use and onset date of the event, causal role cannot be excluded. Other possible confounder is patient's advanced age.
Pt notified staff in Observation that his throat getting a little tight and that was not normal for him. Having slight difficulty swallowing but no problems breathing.  On assessment of Pts throat, the L tonsil, and side of throat was swollen and asymetrical. Notified on site EMS Staff immediately. EMS Staff came and moved pt to a mobile mini paramedic truck where the pts vitals were taken and pt given what looked like liquid Benedryl.  Ambulance called and arrived within a few minutes and pt moved to the ambulance and departed from the site with the PT.
On 7/31/21 patient made an appointment to get a COVID vaccine at our pharmacy. When filling out the screening questions he indicated he had never received a COVID vaccine. That same day he came to our pharmacy and we printed the Voucher from our appointment scheduler. We had him read over questions again and sign. For a second time he attested that he had never received a COVID vaccine. We administered the Pfizer vaccine to him on that day. After administration we entered his information on database. It was then that we discovered he had received the Johnson and Johnson vaccine on 4/6/2. I immediately called patient and questioned him about this. He denied ever receiving the J & J vaccine. I then called the other facility and they confirmed that he did receive J&J vaccine on 4/6/21.
This spontaneous report received from a patient concerned a 76 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient was at high risk of diabetes. The patient received COVID-19 vaccine (suspension for injection, route of admin not reported, batch number: 042A21A expiry: unknown) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On JUN-2021, the patient experienced low antibodies against covid virus. Laboratory data included: Antibody test (NR: not provided) Antibodies were at 2. The action taken with covid-19 vaccine was not applicable. The outcome of low antibodies against covid virus was not reported. This report was non-serious.
Information has been received on 18-JUL-2018 regarding a case in litigation from a lawyer and a male consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 26-JUL-2012, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 05-APR-2017, the patient was treated at a medical office for a blistering vesicular outbreak, which was diagnosed as herpes zoster. The patient was prescribed acyclovir, CALADRYL lotion and GARAMYCIN ointment for management of his painful symptoms and excruciating pain. As a direct and proximate result of the ZOSTAVAX and/or despite receiving the ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Additional information has been requested.
High fever, nausea, vomiting until 06:00 AM of Dec. 1st. Transfered to ER to Hospital put on fluid and medication released at 4:00 PM on Dec. 1st.
Patient is a 76 y.o. female patient of, MD with history of diabetes, hypertension, hyperlipidemia, COPD, diastolic congestive heart failure, obesity presented to Hospital with fall with left distal radius fracture.   HHC set up  follow up to ID and Orthopedic.    Fall with left distal radius fracture Pathological fracture of left distal radius due to a combination of osteopenia and trauma that alone would not have caused the fracture Ortho consult-recommend nonoperative management Continue splint and pain control Outpatient follow-up with orthopedic surgeon     Covid-19 Virus Infection Date of onset of symptoms: 12/10/22 Symptoms present on admission: No Date of covid positive test: 12/10/22 Vaccination status: vaccinated Imaging: None Oxygen requirements on admission: None Current oxygen requirements: 2 L (home baseline) Medical therapy: Start steroids Consultants following: ID consulted Anticipated special isolation end date: 12/20/22 ID following on pavloxivoid.    Type 2 diabetes Last A1c 6.2 in 10/2022 Continue Lantus plus sliding scale Adjust insulin accordingly   Hypertension Continue home meds   Hyperlipidemia Continue statin  History of diastolic CHF Continue Lasix Aldactone   History of COPD Continue with home inhaler Supportive care
fever 101 for approx 12 hrs, was given APAP every 3 hrs; mom reported constant crying for 3 hrs, then pt slept 3 hrs & woke up crying for 2 more hrs; mom called MD;
Erythema surrounding injection site starting 12 hours after. At 72 hours site is 11x7cm right thigh.
Initial unsolicited case received from a consumer on 29-Jul-2016. This case involves a 48-year old female patient who was vaccinated with a dose of FLUZONE QIV (batch number: UI482AB and expiry date: 30-Jun-2016) via intramuscular route, in the left deltoid on an unspecified date in Oct-2015. The patient denied having any illness at the time of vaccination and also denied pre-existing physician diagnosed allergies, birth defects and medical conditions. The patient stated that she experienced the same symptoms after receiving allergy shots. Concomitant medications were not reported. On an unspecified date in Oct-2015, post vaccination, patient experienced low back and r (right) hip pain. She was evaluated and treated by her chiropractor and her massage therapist. Laboratory data and corrective medications was not reported. On an unspecified date, patient recovered from the events. List of documents held by sender: none.
Had HPV4 immunization at approx. 6:00pm and at 9:00pm patient had a seizure.  she was taken to the Emergency department and kept overnight.  This Am she is still experiencing severe dizziness with loss of balance and headache.  5/18/07 Received medical records from ER which reveal patient was at hospital getting ready for sleep study when she had abdominal pain & a witnessed seizure.  Loaded w/Pb & referred to PCP. PMH: FINAL DX: new onset seizures.