chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a published literature article, referring to a 5 year old male patient. On an unknown date the patient was vaccinated with rotavirus vaccine (manufacturer unknown) (strength, dose and lot # not reported), orally. The patient had been fully immunized. On an unknown date in 2013, during the patient's February 2013 school break, on the road of family vacation to a beach, the patient's old sister who had previously complained that she did not feel well, proceeded to vomit. The patient's old sister did not receive rotavirus vaccine. Over the next several days, the patient's old sister was mildly ill with abdominal pain, occasional vomiting, and diarrhea. Although she showed glimmers of improvement, 3 days later she awoke with bilious vomiting and periumbilical abdominal pain. On arrival at the closed pediatric hospital, the physician noted significant dehydration, administered ondansetron, attempted oral hydration, and thought that intravenous rehydration and basic laboratory tests were needed. The physician stated that she probably had gastroenteritis. The patient's old sister's laboratory results were notable for bicarbonate level of 10 mmol/L and an anion gap of 33. On hospital admission, bacterial stool culture and rotavirus antigen tests were ordered. After receiving hydration overnight, the patient's old sister recovered, and they left the hospital to resume their family vacation. On an unknown date in 2013, the patient experienced gastroenteritis rotavirus despite vaccination. Within 5 minutes of returning from the hospital, the patient vomited while attempting to reach the bathroom. That night, the patient had vomiting and diarrhea, and missed the toilet, 6 of 6 family members of the patient had been ill within 2 weeks. Stool specimens of the patient included rotavirus of genotype G12. On an unknown date, the patient recovered from gastroenteritis rotavirus with no lasting effects. The outcome of vaccination failure was unknown. The reporter considered vaccination failure and gastroenteritis rotavirus to be related to rotavirus to be related to Rotavirus vaccine (manufacturer unknown). This is one of the three reports regarding the same article. The patient's sibling's adverse events were captured in 1506USA003700 and 1506USA003701. Additional information has been requested.
pt reports started to break out in a rash on 10/8/99;some on arms, neck, torso;no greater than 20 lesions;afeb @ this time;reports sl temp occurred 10/6/99 but didn't take temp;
Patient states the notice a painful rash on right thigh on 30 Oct 15. Patient saw her doctor on 31 Oct 15. The doctor diagnosed her with shingles.
Temperature excursions; Expired vaccine stored and then administered; Vaccinated someone two days after the expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccinated someone two days after the expiration date), PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursions) and PRODUCT STORAGE ERROR (Expired vaccine stored and then administered) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccinated someone two days after the expiration date). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursions) and PRODUCT STORAGE ERROR (Expired vaccine stored and then administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccinated someone two days after the expiration date), PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursions) and PRODUCT STORAGE ERROR (Expired vaccine stored and then administered) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product use was reported. Dose administered after manufacturer date of expiry,4 doses were administered, 2 boosters and 2 second boosters. The vial was initially stored in the refrigerator on 15-Jul-2022 The vial underwent  temperature excursion. No treatment information was provided.
Strange muscle spasm (that he did not feel) of the upper arm during vaccination..patient will follow up. He stated that a previous pharmacist experienced the same reaction from his muscle (again he did not feel) but he later had a stiff neck for 6 weeks...I was not told of this prior to vaccinating patient.
Muscle pain, joint pain, chills, fever 101.8, headache. Took Tylenol, but it did not help. Took Advil which helped. I had Covid-19  in November.
Headache, Myalgia, Arthralgia, sore throat, congestion Narrative:
Syncope, dizziness. BPs 92/54 (pulse 75), 105/60 (pulse 82). O2 sat 100%.
Complained of itching in her throat and face around 12:13pm after she received the Pfizer vaccine.  Was given 50mg  Benadryl IM. and EMS was notified at 12:20pm. Stated that she felt an improvement within five minutes when the itching began to stop.
Normal redness at injection site; Swollen/swelling at injection site; Arm started itching; Rash 6 inches by 3 inches across; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Arm started itching), RASH (Rash 6 inches by 3 inches across), VACCINATION SITE ERYTHEMA (Normal redness at injection site) and VACCINATION SITE SWELLING (Swollen/swelling at injection site) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced PRURITUS (Arm started itching) and RASH (Rash 6 inches by 3 inches across). On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (Normal redness at injection site) and VACCINATION SITE SWELLING (Swollen/swelling at injection site). On 06-Mar-2021, PRURITUS (Arm started itching) and RASH (Rash 6 inches by 3 inches across) had resolved. At the time of the report, VACCINATION SITE ERYTHEMA (Normal redness at injection site) and VACCINATION SITE SWELLING (Swollen/swelling at injection site) outcome was unknown.            No concomitant medications were reported.No treatment information was provided.Action taken with mRNA-1273 in response to the events was not applicable.
QUARTER SIZED PAINFUL, RED, FIRM MASS IN ARM WHERE VARIVAX GIVEN.
PATIENT WAS DIAGNOSED WITH COVID AFTER RECEIVING BOTH COVID VACCINATIONS AND BOOSTER
sore arm; Slight pain at injection site; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (sore arm) and VACCINATION SITE PAIN (Slight pain at injection site) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (sore arm) and VACCINATION SITE PAIN (Slight pain at injection site). At the time of the report, MYALGIA (sore arm) and VACCINATION SITE PAIN (Slight pain at injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       concomitant medication history not provided. Treatment information was unknown.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: follow up received on 25-MAY-2021. contain non significant information
Arm still has a burning achy feeling that radiates from shoulder down to fingers. Muscle and joints feel swollen and painful. Still having issues 25 days after first dose. Have tried NSAIDS / APAP to try to reduce pain and inflammation. It doesn't help much at all.
I caught the flu really bad/suspected vaccination failure; I caught the flu really bad/suspected vaccination failure; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, less than a year after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced vaccination failure (serious criteria GSK medically significant) and influenza. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the influenza was recovered/resolved.   It was unknown if the reporter considered the vaccination failure and influenza to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The patient reported the case for himself/herself. The age at vaccination was not reported. The patient reported that the only time the patient took the flu shot caught the flu really bad and commented never again for him/her and never caught it again and to each their own. This case was considered as suspected vaccination failure as laboratory test confirmation and time to onset for the event was unknown at the time of reporting.
having headaches most everyday since the shot; Cough; COVID-19; Pain in legs; Fatigue; pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in legs), COVID-19 (COVID-19), COUGH (Cough), FATIGUE (Fatigue) and VACCINATION SITE PAIN (pain at injection site) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Osteoarthritis. Concomitant products included LISINOPRIL for an unknown indication.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2021, the patient experienced FATIGUE (Fatigue) and VACCINATION SITE PAIN (pain at injection site). On 09-Jan-2021, the patient experienced PAIN IN EXTREMITY (Pain in legs). On 13-Jan-2021, the patient experienced COVID-19 (COVID-19). On 15-Jan-2021, the patient experienced COUGH (Cough). On an unknown date, the patient experienced HEADACHE (having headaches most everyday since the shot). The patient was treated with IBUPROFEN at a dose of 1 dosage form as required. On 13-Jan-2021, FATIGUE (Fatigue) and VACCINATION SITE PAIN (pain at injection site) had resolved. At the time of the report, PAIN IN EXTREMITY (Pain in legs), COVID-19 (COVID-19), COUGH (Cough) and HEADACHE (having headaches most everyday since the shot) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Jan-2021, SARS-CoV-2 test: positive Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: Follow up added- Patient reported new event and stated she did not fill the form as it is too big and detailed.
I am pregnant for 8 weeks; Premature live birth; This is a spontaneous report from a contactable consumer (patient). This consumer or other non hcp reported information for both mother and fetus/baby. This is a mother report.  A 29-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: ER8734) via an unspecified route of administration, administered in Arm Left on 08Apr2021 at 16:00 (at the age of 29-year-old) as dose 2, single for COVID-19 immunisation. The patient medical history was not reported. There were no concomitant medications. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EN6204) via an unspecified route of administration, administered in Arm Left on 11Mar2021 at 16:30 (at the age of 29-year-old) as dose 1, single for COVID-19 immunisation. It was reported that patient did not smoke and drink alcohol during pregnancy. It was reported that patient did not use illicit drugs during pregnancy. It was reported that patient had no previous Pregnancy. It was reported that patient had no problems before delivery, during delivery and after delivery. Gestational age at birth in weeks reported as 34 weeks. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that the patient's husband did not smoke and drink alcohol during pregnancy. It was reported that the patient's husband did use illicit drugs during pregnancy. The patient reported she was pregnant for 8 weeks (maternal exposure during pregnancy) and she has not had any symptoms so far, she was feeling well. She sent this message making myself available for any follow-up or research that you want to do with pregnant women, she will be happy if she can help or contribute with something in some study. Thank you very much and congratulations on your work. On 01Nov2021 it was reported that premature live birth on unknown date in 2021. The mother reported she became pregnant while taking bnt162b2. The mother was 9 Weeks pregnant at the onset of the event. The mother was due to deliver on 06Nov2021. The patient underwent lab tests and procedures which included urine analysis: positive on 03Mar2021 Pregnancy. Outcome of the events was unknown.  Information on the lot/batch number has been requested.  Follow up (01Nov2021): This is a follow-up spontaneous report received from a contactable consumer. This consumer reported in response to EDP letter which included that: dose 1 and dose 2 information, patient age, height, weight and clinical course information.
The symptoms occur. Rash started on the left thigh 2 days after immunizations (Immunizations given 11/29/17). Large indurated area without pain or itch (per mom). Rash started to spread all over the body covering the legs torso chest back and now on the face. Temperature of 102.0 started 12/7/17. Seen at the ER on 12/8/17 and Dx with reaction to the immunizations. Rx for Cephalexin started.  Fever resolved after starting the antibiotics and has not returned. A reddened area on the right thigh also appeared about 1 week after the immunizations were given. Patient still has the rash, although it is starting to improve. Eating and drinking well. Appears in no distress.
tested positive for covid; tested positive for covid; This is a spontaneous report from a contactable nurse who reported for herself. A 25-year-old female patient received her first single dose of BNT162B2 (Pfizer-BioNTech Covid-19 vaccine) on 22Jan2021 for Covid-19 immunization. The patient's concomitant medications were not reported. The patient got her first dose on 22Jan2021 and was tested positive for Covid that night due to close contact with a friend that had had a positive test. Her next vaccination date was after the 14 days quarantine but she was wondering if someone kept testing positive after that 14 day period, she knew some people test positive for months. She would like to know was it still safe to get the second dose. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on the information currently available, a lack of efficacy with the suspected vaccine BNT162B2 in this patient cannot be completely excluded. While the vaccine may not provide protection yet, further clinical information is needed for meaningful medical assessment.
Fever; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a 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 fever. On an unknown date, the outcome of the fever was not recovered/not resolved.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional details were reported as follows: Age at vaccination was not reported. The reporter wanted to know how long does a fever last after the Shingrix Vaccine.
Extreme muscle pain in arm - could not sleep because of pain for 3 days,   Extremely tired 4 days at injection sight about a 5 inch circle swelling, rash, itching. pain still today 6 days after shot couldn't do regular routine for 4 days
Swelling, induration, redness around injection site 10-15 cm area within 12-24 hours. Improved after 2 days no fever or constitutional symptoms.
Daughter said she felt queasy, and passed out while standing over the toilet.  She collapsed in my arms, and was unresponsive for 5-10 seconds.  When she came to, she said she was disoriented and said she was very hot; felt warm to the touch as well.
Approximately 4 minutes post vaccine pt fainted in chair during obs. Pt transferred to gurney, RRT called at 0840, they arrived 0846. Denies high BP. Vitals taken (0843)198/95, HR 96 o2 97% T-98.6. Pt comes to and reports hx of fainting with needles and nausea. No medical hx. Currently feels better and refuse to go to ER x3.  V/s(0846) 195/95 HR 81 o2 97%. Husband by bedside fans pt. Continues to refuse ED service. (0855) 124/60 HR 81 o2 97% RRT left at 0852. Pt became anxious 0942 BP 173/81 HR 83 o2 97% pt wants to be released home AAO. D/C @ 0945 with husband.
Information has been received from a medical assistant concerning a 17 year old female patient who on 24-SEP-2010 was vaccinated with a first 0.5ml dose of GARDASIL (Lot# 662765/1353Y), IM. Concomitantly on the same day, she received a dose of influenza virus vaccine (manufacturer unknown). It was reported that the patient experienced changes in her menstrual cycle after being administered GARDASIL. At the time of the report the patient's outcome was unknown. The patient did not seek medical attention. This is one of several reports received from the same source. Additional information has been requested.
I became very ill, started with extreme fatigue, tiredness, low blood pressure, vertigo. Next 6 months, I visited different doctor offices. I had allergy tests done, I had endoscopy and colonoscopy. By the time I diagnosed with ulcer by the July, my symptoms were already starting fades away. By the time doctor put me to the omeprazole for ulcer treatment, I didn't had those severe symptoms that I described. I truly believe flu shot made me very ill and it went away as time passed by. Now I am not sick. I know it was a flu shot, but I don't know exact vaccine name.
24Feb2021 the injection site is pale; Fatigue; injection site was warm; injection site was bright red; area swelled to the size of a Tennis Ball; soreness; hardness the size of a quarter at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PALLOR (24Feb2021 the injection site is pale), VACCINATION SITE INDURATION (hardness the size of a quarter at the injection site), VACCINATION SITE WARMTH (injection site was warm), VACCINATION SITE ERYTHEMA (injection site was bright red) and VACCINATION SITE SWELLING (area swelled to the size of a Tennis Ball) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0161M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced VACCINATION SITE INDURATION (hardness the size of a quarter at the injection site) and VACCINATION SITE PAIN (soreness). On 19-Feb-2021, the patient experienced VACCINATION SITE WARMTH (injection site was warm), VACCINATION SITE ERYTHEMA (injection site was bright red) and VACCINATION SITE SWELLING (area swelled to the size of a Tennis Ball). On 24-Feb-2021, the patient experienced PALLOR (24Feb2021 the injection site is pale) and FATIGUE (Fatigue). At the time of the report, PALLOR (24Feb2021 the injection site is pale), VACCINATION SITE INDURATION (hardness the size of a quarter at the injection site), VACCINATION SITE WARMTH (injection site was warm), VACCINATION SITE ERYTHEMA (injection site was bright red), VACCINATION SITE SWELLING (area swelled to the size of a Tennis Ball), VACCINATION SITE PAIN (soreness) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported.  No treatment medications provided by the reporter.   Reporter did not allow further contact
A COUPLE DAYS AFTER INJECTION I WOKE UP WITH PAIN IN THE LEFT SIDE OF MY NECK AND LEFT SHOULDER. EVERY DAY THE PAIN BECOMES MORE NOTABLE AND THE PAIN CONTINUES DAY AND NIGHT LIKE A CONTINUOS THROBBING IN MY LEFT SHOULDER. I CAN NOT TILT MY  HEAD BACK ON THE LEFT SIDE AND I FEEL A SHARP PAIN WHEN I TRY.
only received the diluent and not the lyophilized powder portion with no reported adverse event; Initial information received from country on 06-Nov-2023 regarding an unsolicited valid non-serious case received from a pharmacist.  This case is linked to cases 2023SA343804, 2023SA343771 and 2023SA345528.  This case involves 16 months old male patient who only received the diluent and not the lyophilized powder portion for HIB (PRP/T) VACCINE [ACT-HIB] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (Daptacel) for Immunisation; Hepatitis A Vaccine for Immunisation; and influenza vaccine (Flu [influenza vaccine]) for Immunisation.  On 30-Oct-2023, the patient received a standard dose 4 of suspect HIB (PRP/T) vaccine Powder and solvent for solution for injection at a dose of 0.5 ml total (lot UK007AB, expiry date- 31-DEC-2024) via intramuscular route in the left thigh for Immunization.  On 30-OCT-2023 the patient only received the diluent and not the lyophilized powder portion with no reported adverse event (single component of a two-component product administered) (latency- same day) following the administration of HIB (PRP/T) vaccine.  Reportedly, Pharmacist reported that four patients received a dose of ACTHIB. However, one patient only received the diluent and not the lyophilized powder portion. They noticed there was one extra powder vial left but they are unsure which patient only received the diluent. Should they revaccinate all or should they do serologic testing prior to re-administering? Treatment: The caller was not aware of any adverse reactions, treatment.  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 the Directive and Module 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.