chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fluarix exposed to freezing temperature was administrated; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 26-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2021-2022 season) (batch number LZ4N2, expiry date 30th June 2022) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 11th October 2021, the patient received Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device. On an unknown date, unknown after receiving Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details provided were as follows: The health care professional called and reported that a Fluarix QIV that was exposed to freezing temperature was administrated to a patient, which led to incorrect storage of drug. No symptoms or further details were reported. The reporter agreed to follow-up. This case was 1 of 8 case reported by the same reporter.
On 3/2/00, the pt developed 7 pox on his torso. The reporting physician noted that the pox were small vesicles consistent with varicella. The pt remained afebrile. The physician noted that the pt was treated with Acyclovir.
Skin issues; This spontaneous case was received on 10-Oct-2023 from other health professional via agency (reference number SEQW23-03184) and concerned a female patient of unreported age.  The patient's concurrent condition included allergy to formaldehyde. The patient's concomitant medication were not reported.  On an unspecified date, the patient was vaccinated with Influenza virus vaccine (brand not specified; dose, route of administration, anatomical location, and indication: not reported). The batch number was not reported.  On an unspecified date, a couple days after receiving influenza virus vaccine, the patient experienced some skin issues and did not have a severe reaction. The patient found out through testing their home that they had some chemicals that were causing her and her kids some issues, respiratory and GI (gastrointestinal). Additionally, the patient found out that she did have sensitive reaction to formaldehyde, as reported. The patient asked was it okay to take flu shot again and wanted to know about formaldehyde in Flucelvax. As reported, the patient was panicking and freaking out because in consent form there was a question: Have you ever had a reaction to formaldehyde?   On an unspecified date, the patient recovered from the event.  The reporter did not provide a causality assessment.  The case was assessed as non-serious.  Company comment: A female patient of unreported age was vaccinated with influenza virus vaccine. After unknown amount of time (reportedly, a couple of days after receiving the influenza vaccine), patient noticed some skin issues that were not severe. As reported, patient has an known allergy to formaldehyde. Concomitant medication and relevant diagnostic findings were not provided. Considering lack of information regarding chronology, vaccination date and event onset date, as well as other above mentioned relevant information, causal role of the suspect vaccine for the event of skin disorder is unassessable.; Sender's Comments: A female patient of unreported age was vaccinated with influenza virus vaccine. After unknown amount of time (reportedly, a couple of days after receiving the influenza vaccine), patient noticed some skin issues that were not severe. As reported, patient has an known allergy to formaldehyde. Concomitant medication and relevant diagnostic findings were not provided. Considering lack of information regarding chronology, vaccination date and event onset date, as well as other above mentioned relevant information, causal role of the suspect vaccine for the event of skin disorder is unassessable.
Severe muscle aches/cramps throughout the body once I (patient) went to bed at 11pm, followed by profuse sweating and fever that reached 102F by midnight; severe chills, nausea, headache, dizziness all began by 1:00am and continued throughout the next 8 hours. I was unable to leave bed during the night due to the aches and severe dizziness. By Monday morning at 8:00am the chills had stopped but all other symptoms remained along with severe fatigue. I was able to sleep until approximately 12:30pm and the only remaining symptoms were mild muscle aches, nausea, and severe dizziness/lightheadedness. Those symptoms remained until waking up at 8:00 Tuesday 5/18. As of 5/18, I have mild dizziness but all other reactions have stopped.
Low grade fever 99.6 ºF - 100.8 ºF; Chills; Slight headache; Feeling fatigued; Had cramps on their stomach; Soreness; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Had cramps on their stomach), PAIN (Soreness), PYREXIA (Low grade fever 99.6 ºF - 100.8 ºF), CHILLS (Chills) and HEADACHE (Slight headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, the patient experienced PAIN (Soreness). On 10-Mar-2021, the patient experienced ABDOMINAL PAIN UPPER (Had cramps on their stomach), PYREXIA (Low grade fever 99.6 ºF - 100.8 ºF), CHILLS (Chills), HEADACHE (Slight headache) and FATIGUE (Feeling fatigued). On 04-Mar-2021, PAIN (Soreness) had resolved. At the time of the report, ABDOMINAL PAIN UPPER (Had cramps on their stomach), PYREXIA (Low grade fever 99.6 ºF - 100.8 ºF), CHILLS (Chills), HEADACHE (Slight headache) and FATIGUE (Feeling fatigued) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Mar-2021, Pyrexia: low grade 99.6 ºF - 100.8 ºF.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
hard swell about the size of a baseball around the vaccination site on the right arm. No discoloration, painful to the touch
Lymph node in the neck is swollen; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Lymph node in the neck is swollen) in an 88-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A and Unknown) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 22-Feb-2021, the patient 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced LYMPHADENOPATHY (Lymph node in the neck is swollen). At the time of the report, LYMPHADENOPATHY (Lymph node in the neck is swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication information was not provided. Concomitant medication was not provided.
Maculopapular rash neck and trunk, and spare lesions on legs. Measly rash 20 hours after immunization (MMR - given on 8/3/07)
This spontaneous report was received from a health care professional refers to unspecified number of unspecified patients of unknown age. On an unknown date the patients were vaccinated with improperly stored GARDASIL 9 (L006547 exp. 04-MAR-2017) (route, dose and frequency unspecified). Other suspect therapies included the patients were vaccinated with improperly stored ROTATEQ (K009181 exp. 24-APR-2016, K017573 exp. 11-JUN-2015) and RECOMBIVAX HB (K008986 exp. 01-APR-2016, K021444 exp. 17-SEP-2016) (route, dose and frequency unspecified). No concomitant therapy were reported. Additional information has been requested.
No fever, but injection site is noticeably hotter than surrounding skin to the touch. Likely by a few degrees, given that it is perceptible merely to the touch.
Approximately 5-6 days post injection, patient states that her knee joints and leg swelled and that she could not walk for 2 to 3 days. She feels that this was directly related to the administration of Prevnar 13.
Administered expired vaccine to the patient, after the manufacture date of expiration.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to the patient, after the manufacture date of expiration.) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to the patient, after the manufacture date of expiration.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to the patient, after the manufacture date of expiration.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Date the vial was initially stored in the refrigerator was unknown. The vial did not undergo any temperature excursions. Vaccine manufacture date of expiry reported was 09-Nov-2021. No treatment details were reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow-up document included no new information.
stomach flu; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 07Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: GASTROENTERITIS VIRAL (non-serious), outcome "unknown", described as "stomach flu".  Additional information:Patient wants to check if she can take the covid-19 vaccine today since she had been diagnosed with stomach flu in between doses. She had the first dose last April 7. 2nd dose is today (April 28).   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
No appetite for two weeks on 1st Vax; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 12Apr2021 09:30 (Lot number: EW0151) at the age of 47 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Allergies: Shellfish" (unspecified if ongoing), notes: Known allergies Shellfish. Now apparently, all meat; "Allergies: all meat" (unspecified if ongoing), notes: Known allergies Shellfish. Now apparently, all meat. The patient took concomitant medications. The following information was reported: DECREASED APPETITE (non-serious) with onset Apr2021, outcome "unknown", described as "No appetite for two weeks on 1st Vax".  Additional information:  No appetite for two weeks on 1st Vax. Then seemed to have a sensitivity to meat. The patient did not receive any other vaccine within 4 weeks, received allergy medications in 2 weeks. prior and since vaccination patient was not tested for covid.   No follow-up attempts are possible. No further information is expected.
Mon 4/12/21 - Headaches started and have continued daily. Tue 4/13/21 - Soreness in right calf muscle, continued for 4 days.  Headache continued. Wed 4/14/21 - Sharp pain in pelvis (right and left side) same location I experienced pain the day of receiving vaccine.  Occasionally felt this pain 2 or 3 times / day for 2 days.  Sought medical attention at ED on the advice of our Nurse Call Center.  Was evaluated for blood clots, none found on this day.  CT scan, ultrasound of both legs, blood tests.  Returned home with directions to take Extra Strength Tylenol for headache. Thu 4/15/21 - Shooting pain in random parts of my body, mostly legs and arms.  Experienced throughout this day only. As of 4/27/21, 22 days after being vaccinated, I am still experiencing headaches.  More noticeable when I am exerting myself - walking outside for 1-2 minutes triggers the headache.  Headaches are usually located in the lower back of my head.  Before being vaccinated, I would experience less than 1 headache per month, and they go away within the day.
Family came from the exam room to check out. While checking out the patient passed out and hit her head on the wall.
body ache and testicular pain Narrative: Patient had the vaccine at a non-facility on 3/4/21. On 3/5/21 he presented to the ER with body aches and left testicular pain that made walking difficult. These symptoms started after vaccination. The patient also reported chest pains x3 days which predated the vaccine.
Not even a month after second shot I got heart palpitation. Pcp confirmed ekg off and had to get heart echo. Horrible fatigue when I was eating and sleeping right. I would get headaches at the same time every afternoon.  I then began breaking out along the sides of my neck with cystic acne. My left ear has completely mutated and still is changing. My right ear has been filled with fluid for months and no one knows why. I?ve been hospitalized 4 times for eyes swelling shut, staph infection and forehead/ eyes filling w fluid.   I was completely healthy until I got the vaccine. Now it?s all I can do to work an 8 hr shift to hold onto whatever I have left after employer denied disability benefits.  My cheeks are filled w fluid which has trailed down into my mouth as pockets of fluid/ mouth sores.
Patient complained of a sore arm. She went to urgent care on 3/2/22. diagnosed with Lymphadenitis and was give IM rocefin and Cephalexin PO
shingles activation after having the first dose; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 69-year-old female patient who received Herpes zoster (Shingrix) (batch number 75P7G, expiry date 17th April 2022) for prophylaxis.   On 25th September 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 weeks after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The patient received the 1st dose of Shingrix and experienced shingles which was not recovered till the time of reporting. The reporter did not consented to follow up. No further information was available.
Information has been received from an other health professional referring to multiple unspecified patients of unknown age and gender. There was no pertinent medical history, concurrent conditions, concomitant medication or drug allergies/drug reactions described. On unspecified dates, the patients were vaccinated with improperly stored GARDASIL Lot#L007560 with expiration date of 15-JUN-2017 (or another unspecified Lot #) (dose and route were not reported), which were stored at 30 F for 30 minutes. The previous temperature excursion included 31 F to 35 F for 9.5 hours total cumulatively. No adverse effect was reported. Additional information has been requested.
Since getting the first vaccine I began spotting within two weeks of ending my regular period, which is very unusual since I have the implanon birth control. I have been spotting/ bleeding for over a week straight now, when I should even be having a period at all. I also developed a slight yeast infection during the time between my two doses.
PATIENT STATES TINGLONG IN FACE WITH NO SHORTNESS OF BREATH OR WHEEZING. BLOOD PRESSURE IS 144/70, HEART RATE IS 66, RESP RATE IS 18, O2 IS 98% ON ROOM AIR. PATIENT DENIES THROAT ITCCHING OR OTHER COMPLAINTS AT THIS TIME. PATIENT MONITORED FOR ADDITIONAL 15 MINS AND RELEASED IN NO APPARENT DISTRESS.
FEELING BLAH; SORE ARM; CHILLS; MILD FEVER; FEELING TIRED; MUSCLE ACHES LEFT LEG; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient previously received influenza vaccine for prophylactic vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) (series 1), administered in MAR-2021 for prophylactic vaccination. The patient received a booster dose (series 2) with non-company suspect vaccine MRNA 1273 (form of admin, route of admin, and batch number were not reported) on 23-OCT-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 MAR-2021, when the patient initially received the Janssen vaccine after vaccination on an unspecified date, the patient experienced feeling blah, sore arm, chills, mild fever, and feeling tired. When the patient received the Modern booster vaccine on 23-OCT-2021, the patient experienced muscle aches in left leg. Laboratory data included: Body temperature 100.1, 99.7, 98.7, 101. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, was recovering from sore arm, had not recovered from mild fever, feeling tired, and feeling blah, and the outcome of muscle aches left leg was not reported. This report was non-serious.
Pain level 8/10, redness and swelling at injection site, swollen lymph node under arm size of 1/2 dollar, denies fever or malaise. Instructed to take Tylenol and use ice. Signs and symptoms of infection reviewed with patient by  nurse. Patient states understanding to go to doctor if it worsens.
felt like I had a bladder infection; This spontaneous case was reported by a patient and describes the occurrence of CYSTITIS (felt like I had a bladder infection) in a 71-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. 8058492) for COVID-19 prophylaxis.     The patient's past medical history included Knee replacement in September 2023.    On 16-Nov-2023 at 5:00 PM, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In November 2023, the patient experienced CYSTITIS (felt like I had a bladder infection). The patient was treated with AMOXICILLIN for Bladder infection, at an unspecified dose and frequency. At the time of the report, CYSTITIS (felt like I had a bladder infection) had not resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Reported that after administration of vaccine patient felt like she had a bladder infection and took left over Amoxicillin. Patient stated it was prescribed for a bladder infection.   Reporter did not allow further contact
Hives, pal pitations , lightheaded Txc Dexamethasone prednisone
swollen lymph nodes that started on his right side; swollen lymph nodes have gotten worse since yesterday; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 39 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 07Apr2021 18:30 (Batch/Lot number: unknown) at the age of 39 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 11Apr2021, outcome "not recovered", described as "swollen lymph nodes that started on his right side (not the side where he received the vaccine) in his armpit area, and on his right chest, and now they're noticeable on his left armpit, as well/little annoying and a little painful"; CONDITION AGGRAVATED (non-serious) with onset 11Apr2021, outcome "unknown", described as "swollen lymph nodes have gotten worse since yesterday".  Additional information included: Patient was now reporting swollen lymph nodes that started on his right side (not the side where he received the vaccine) in his armpit area, and on his right chest, and now they're noticeable on his left armpit, as well. He doesn't report that they were bothersome or painful. Caller wants to know if this has been reported before, and if he should follow-up with his physician?. Patient reported that he read online that swollen lymph nodes are a common adverse event. Patient stated that he wanted to double check if swollen lymph nodes have been reported and inquired if he should follow up with his physician about the swollen lymph nodes or wait a couple of days. Patient reported that he read online that the swollen lymph nodes are more normal to feel on the side that you received the injection of the Covid-19 vaccine in. Patient reported that the lymph nodes on his left side are swollen but have progressively felt more swollen. Patient reported that his lymph nodes are swollen on his right side as well, and that he can feel a lymph node on his right chest that is also a little annoying and a little painful. Patient reported that the swollen lymph nodes have gotten worse since yesterday, but were not something alarming. Caller reported that his personal concern is that usually when his lymph nodes are inflamed, it is usually because of infection. Patient reported that his lymph nodes seem to work pretty well, and that if they are swollen because of the Covid-19 vaccine, it makes sense as he had the vaccine 4-5 days ago. Patient unable to provide product details. Patient reported that his vaccine card was in his car and he was unable to locate the information elsewhere. No additional vaccines administered. No emergency room visit required. No physician office requires. No medication prior vaccinations within 4 weeks. No family medical history to adverse event. No relevant lab test were reported.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt reported needing a booster. he was given 0.25ml of moderna vaccine, but upon reconciliation, it was determined that he had only had 1 dose of Moderna, meaning he needed a second 0.25ml to receive the second vaccine. Upon further review, the patient was given these doses too closely to his initial dose of Moderna and will need to complete a full second dose in several weeks to get back on track with his vaccine.