chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient was administered a dose of Bexsero on 08Jul2022 from lot number ABXA87AZ, which had an expiration date of 31Jan2022.; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 18-year-old male patient who received Men B NVS (Bexsero) (batch number ABXA87AZ, expiry date 31st January 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Meningococcal B Vaccine Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 8th July 2022, the patient received the 1st dose of Bexsero and Meningococcal B Vaccine Pre-Filled Syringe Device. On 8th July 2022, unknown after receiving Bexsero and Meningococcal B Vaccine Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used 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 Information: GSK receipt date - 08 July 2022 Reporters comment: The medical assistant reported the patient was administered a dose of Bexsero which had an expiration date of 31st January 2022. This was the patient's first dose in the series. At the time of reporting repeat dose was not administered. The reporter consented to follow up.  The Vaccine Administration Facility was the same as Primary Reporter. Additional Supportive information: The patient received Bexsero which was already expired which led to expired vaccine used.
I received the Pfizer Covid-19 Vaccine on 3/8/20201  Adverse Reactions  Fever (103) Sore Muscles Throwing up Bad Headache
Chief Complaint: FEVER, CHILLS, MUSCLE ACHES, SORE THROAT, NAUSEA, BACK PAIN and HEADACHE.  This started today and is still present.  At its maximum, severity described as moderate. When seen in the E.D., severity described as moderate.  Modifying factors. Not worsened by anything. Not relieved by anything.  The patient has had a headache and muscle aches.    (Pt notes had an IM Moderna COVID vaccine in her left deltoid around 0930 yesterday morning.  This morning at 0300 woke up "freezing cold".  Pt turned up the thermostat.  Pt also noted generalized myalgias.  Also noted a numbness sensation in her LUE.  Pt went to work and advised by to go home.  Pt notes she feels her body is is "spasms" and feels as if someone is pulling her hair really hard.  Pt therefore came to the ER.).
1st dose was Menactra, this dose MenQuadfi.  Pt developed hives all over the day after vaccination
vaccine given on 04/27/2023 pt waited in clinic for 15 min after vaccine was administered  by,CMA -Vaccine given was not the correct covid dose. 05/08/2023 T/C with mom and explained that patient was administered a lower Moderna dose than the CDC recommends. Recommendation is to have this dose re-peated appt schedule on 06/26/2023 for booster vaccine. Mom says patient has been exhausted and has been stumbling since then, but mom also says patient has only recently begun walking; she is unsure if this is related to the vaccination given.
lesions on the top of her mouth/It feels like the tissue is coming off the top of her mouth; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. A 66-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: WE0177; Expiration Date: 31Aug2021), via an unspecified route of administration, administered in left arm on 18May2021 19:30 (at the age of 66-year-old) at single dose for Covid prevention. The patient medical history was not reported. Concomitant medication included pantoprazole sodium sesquihydrate (PANTOPRAZOLE 40mg) orally at 40mg daily for acid reflux (has been taking several years). No history of previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines administered on same date of the Pfizer suspect. No prior vaccinations within four weeks prior to the first administration date of the suspect vaccine. On 19May2021 (Today as reported), she developed lesions on the top of her mouth and was reported as worsened. She wanted to know if that is a normal reaction. It feels like the tissue is coming off the top of her mouth. The outcome of event was not recovered.  No follow-up attempts are needed. No further information is expected.
Arm where vaccine was given began to show a red slightly swollen outline around the vaccine site 8 days after vaccination. Redness and outline disappeared as the day went on but swelling and slight soreness was present on day 9
Dime sized red mark an injection site on right leg, no itching, fussines, or pain.
Upon waking  at 5am the morning (Friday) following the 2nd injection, the injection site was swollen, hard and hot to the touch. Movement of my arm caused slight discomfort. By 11am, my arm throbbed/ached and felt very heavy. By 12PM, all of the joints in my left arm, from the shoulder through my elbow and wrist into the joint of my fingers were burning and aching. By 4PM, I could not lift my left arm above my shoulder. The pain and burning persisted throughout the night with any movement. Saturday morning the intensity of the pain and burning had tapered off slightly and my range of motion improved slightly. It is Monday morning and while I seem to have the majority of my range of motion back, It is painful to fully extend my arm or raise my arm to should height or higher.
very bad had to go to the hospital; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (very bad had to go to the hospital) in a female patient of an unknown age 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) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (very bad had to go to the hospital). At the time of the report, VACCINATION COMPLICATION (very bad had to go to the hospital) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment medications were reported.
Massive headache, major body aches, joint pain, fatigue, nausea, left arm pain (injection site)
Covid arm; arm swelling; stiff arm; warm to touch; Rash red; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Covid arm), PERIPHERAL SWELLING (arm swelling), MUSCULOSKELETAL STIFFNESS (stiff arm), SKIN WARM (warm to touch) and RASH ERYTHEMATOUS (Rash red) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049c21a) for COVID-19 vaccination.     Has had copd, sleep apnea, diabetes type 2 and stage 4 congestive heart failure. Allergic to ace inhibitors and codeine.  Concurrent medical conditions included Specific allergy (drug) (Allergic to Ace inhibitor), Specific allergy (drug) (Allergy to Codeine), COPD, Sleep apnea, Diabetes and Congestive heart failure (stage 4 congestive heart failure).    On 09-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Cutaneous) 1 dosage form. On 15-Jun-2021, the patient experienced PAIN IN EXTREMITY (Covid arm), PERIPHERAL SWELLING (arm swelling), MUSCULOSKELETAL STIFFNESS (stiff arm), SKIN WARM (warm to touch) and RASH ERYTHEMATOUS (Rash red). At the time of the report, PAIN IN EXTREMITY (Covid arm) and PERIPHERAL SWELLING (arm swelling) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Cutaneous) was unknown.       No relevant concomitant medication was reported. Treatment information was not provided.
1st dose: 12Mar2021, 2nd dose: 19Apr2021; Swollen arm ,  It has worsened , The swelling is spreading; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swollen arm ,  It has worsened , The swelling is spreading) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose: 12Mar2021, 2nd dose: 19Apr2021) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043821A and Q38A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In April 2021, the patient experienced PERIPHERAL SWELLING (Swollen arm ,  It has worsened , The swelling is spreading). On 19-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose: 12Mar2021, 2nd dose: 19Apr2021). The patient was treated with VITAMIN D NOS for Swollen arm, at an unspecified dose and frequency; CORTISONE for Swollen arm, at an unspecified dose and frequency and PREDNISONE for Swollen arm, at an unspecified dose and frequency. At the time of the report, PERIPHERAL SWELLING (Swollen arm ,  It has worsened , The swelling is spreading) had not resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose: 12Mar2021, 2nd dose: 19Apr2021) outcome was unknown.     Concomitant medication included thyroid medication. It was reported that, swelling arm was Worsen.
Severe pain and swelling under arm (same arm as vaccine); Severe pain and swelling under arm (same arm as vaccine); chills; fever; dose received: 3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 22Dec2021 17:15 (Batch/Lot number: unknown) at the age of 60 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Sulfa antibiotis" (unspecified if ongoing), notes: known allergies: Sulfa antibiotis. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6204, Location of injection: Arm Left), administration date: 21Mar2021, when the patient was 60 years old, for COVID-19 Immunization, reaction(s): "No events after first dose"; Bnt162b2 (Dose Number: 2, Batch/Lot No: EP6955, Location of injection: Arm Left), administration date: 09Apr2021, when the patient was 60 years old, for COVID-19 Immunization, reaction(s): "Severe pain and swelling under arm (same arm as vaccine): Same symptoms after second", "Severe pain and swelling under arm (same arm as vaccine): Same symptoms after second", "chills: Same symptoms after second", "Fever: Same symptoms after second". The following information was reported: IMMUNISATION (non-serious) with onset 22Dec2021 17:15, outcome "unknown", described as "dose received: 3"; SWELLING (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 23Dec2021 14:00, outcome "recovering" and all described as "Severe pain and swelling under arm (same arm as vaccine)"; CHILLS (non-serious) with onset 23Dec2021 14:00, outcome "recovering", described as "chills"; PYREXIA (non-serious) with onset 23Dec2021 14:00, outcome "recovering", described as "fever". Therapeutic measures were not taken as a result of swelling, pain in extremity, chills, pyrexia.  Additional information: Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Severe pain and swelling under arm (same arm as vaccine), fever, chills. Same symptoms after second and third vaccine.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Slight side effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Slight side effects) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised (Due to underlying muscle disease.) and Muscle disorder NOS.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Slight side effects). At the time of the report, VACCINATION COMPLICATION (Slight side effects) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medication was reported. No treatment information was reported.   This case was linked to MOD-2021-361351, MOD-2021-361341 (Patient Link).
Developed erythema and itching at site of Varivax injection - approximately 3 cm. diameter. Put on Keflex 250 mg qid.
PATIENT STARTED FEELING BAD ON 10-30-09. ON 10-31-09 THERE WAS SEVERE LIP SWELLING, HEADACHE, RIGHT EYE AND RIGHT MOUTH WERE DROOPING. WAS SEEN BY PHYSICIAN ON 10-31-09 AND WAS DIAGNOSED WITH BELL'S PALSY 11/10/2009 MD visit 10/31/2009. Patient with c/o's lip swelling, rt eye and mouth droop, headache. Tx: steroids. DX Bell's palsy
The second dose was administered at an earlier than recommended date (earlier than 4 day grace period). My first dose was done 09/07/2021. The second dose was done 09/21/21. There was a miscommunication with the nurse giving the vaccine.  She mispoke and stated to come back for the second dose on the 21st instead of 21 days. In result, I came back on exactly the 21st.  My vaccination record card was given to the nurse administering the vaccine, but she did not check the time frame and still gave the second dose despite it being too early (the first dose date was provided on card).  I experienced chills and a sore armpit the same day of the second dose. Symptoms went away after a couple days
Did not experience menstrual cycle until June 28th, 3 months after vaccination. After the second dose, experienced migraine and body aches with chills.
A non-serious spontaneous report of "runny nose" has been received from a consumer concerning a 24-month-old female subsequent to receiving FLUMIST. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. The patient's medical history and concomitant medications were not reported. The patient received FLUMIST on 03-Sep-2010. On 07-Sep-2010, the patient developed a runny nose. No medical attention or other symptoms were reported. The outcome of the event of "runny nose" was unknown.
Information has been received from an RN concerning a 10 year old male with no known medical history or drug allergies who on 10/19/98 was vaccinated with varicella virus vaccine live. There was no concomitant medication. In 12/01, the pt developed chicken pox. He had greater than 100 lesions scattered all over his body. The pt was receiving diphenhydramine (Benadryl) for symptomatic treatment. Unspecified medical attention was sought. Additional information has been requested.
My arm at vaccine site became hot, swollen, and itchy. It was like a wasp sting reaction. The severity of the reaction decreased every day, and it is pretty much gone after 5 days. There is also a small patch of skin that is scaly at the vaccine site.
This spontaneous report as received from a pharmacist refers to a newborn male patient of unknown age. On 13-NOV-2012 at 12:07, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
This spontaneous prospective pregnancy report as received from a consumer's husband refers to a female patient of unknown age. On unknown dates the patient were vaccinated with the first 2 doses of GARDASIL (lot #, expiration, dose unspecified). The reporter stated the second shot was given in approximately 2013 (about a year ago). Two months later after the patient received the second shot, she found out she was pregnant and did not receive the third shot. The Last Menstrual Period (LMP) and Estimated Date of Delivery (EDD) was not known. Since then pregnancy had resolved. No side effects were reported. Therapy with GARDASIL was discontinued. The patient had sought medical attention. Additional information has been requested.
patient reports "not feeling well",  short of breath, difficulty talking between breaths, throat feeling tight and headache.  Epi pen and oxygen administered at 12:38pm.  Patient denies EMS transport to ED for continued evaluation.
Coin shaped eczema patches on torso. I get a new one every day. Headaches
Redness and swelling at site of vaccination about 15mm. Treatment with warm compresses at vaccine site.
This case was reported by a pharmacist via call center representative and described the occurrence of fever in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever, influenza-like symptoms, muscle pain and chills. On an unknown date, the outcome of the fever, influenza-like symptoms, muscle pain and chills were unknown. It was unknown if the reporter considered the fever, influenza-like symptoms, muscle pain and chills to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient experienced flu like symptoms consisting of muscle aches, chills, and fever. The caller was going to ask the pharmacist questions for an adverse drug event (ADE) report.
During the night I woke with shivers, then am was hot and sweating. Also fighting a headache and sensitive stomach. And yes my left arm is quite sore as it was with the first shot.
About 3 weeks after the vaccine, I started getting a patch of Psoriasis on left thigh. I've never had Psoriasis before. Then at the same time, I felt itchy all over. Then a couple more weeks, I developed a rash. I went to the doctor and got a biopsy and it was dermatitis. This happened until January then subsided. Then I got shingles on my left side. I took antibiotics and it took a couple of weeks to go away. At the end of March, I got the injections in my knees again. Then I got the rash again but it was more mild than before. This has been persistent. I did get a prescription of Clobetasol which does help.
Arm had reflex reaction after injection was administered and patient has had discomfort in the arm off and on since.
4/1- vertigo.  4/12 severe vertigo and headaches. loss of balance and a fall.  4/29 balance center.  5/12 optometrist.    5/13 cardiologist for vertigo and headaches  5/18 ENT.  6/7 retina associates.  6/12 MRA of head and neck.  6/22 CTA head.  7/6  neurovascular consult.  7/13 cerebral angiography.  7/15 appt with neurologist.  7/28-8/6 PT.  8/13 MRI of head  I went to all of my doctors to be sure headaches, veritgo, dizziness and balance wasn't due to eyes, stroke, head etc.  Nothing was really diagnosed that would cause these symptoms for so long.  At this point my balance has improved, headaches are intermittent but feel only about 80percent recovered.  I have to be very diligent walking and look directly where I am walking.
No additional AE reported; GARDASIL 9 had been involved in multiple low temperature excursion and was administered; This spontaneous report has been received from a medical assistant referring to a 12 year old patient of unknown gender. The patient's pertinent medical history, drug reactions/allergies, concurrent condition and concomitant medication were not provided.  Hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) had been involved in multiple low temperature excursions of 35 degree Fahrenheit(F) for 0.25 hour (on 03-NOV-2021), 0.75 hour(on 04-NOV-2021), 0.5 hour(on 05-NOV-2021) and 0.25 hour(on 12-NOV-2021), respectively. The previous excursions were unknown. On 12-NOV-2021, the patient was vaccinated with the improper storage hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9)(lot # T030749, expiration date 16-MAR-2023; strength, dose, frequency, route and anatomical location were not reported) for prophylaxis(product storage error).   No additional adverse event (AE) was reported, and no further information provided.
Information has been received from a nurse practitioner concerning a 20 year old female patient with sulfa allergy who on 30-JUN-2010 was vaccinated with a first dose of 0.5 ml of GARDASIL (Lot#Unknown), IM. The nurse practitioner stated that in July 2010 the patient started experiencing ongoing fatigue. In September 2010, the patient was vaccinated with a second dose of 0.5 ml of GARDASIL (Lot#Unknown), IM. There were no laboratories performed. It was reported that the patient had seen multiple other unspecified healthcare providers and the patient was evaluated for Hashimoto's disease and had recently been started on unspecified date and an unspecified dose of SYNTHROID. It was also reported by the nurse practitioner that the patient continued to experience extreme fatigue and the patient's mother believed that it was related to GARDASIL and had her daughter evaluated to investigate other possible causes for the severe fatigue. The patient sought medical attention via office visit. Follow up information has been received from a nurse practitioner who indicated that the patient was a 20 year old female patient who on 30-JUN-2010 was vaccinated IM with the first dose of GARDASIL (Lot # 665759/1377Y) and in September 2010 was vaccinated IM with the second dose of GARDASIL (Lot # 666163/066AZ). Concomitant medications included YAZ. The patient reported significant fatigue since the injection. In July 2010, the patient experienced fatigue. She saw an endocrinologist and was taking SYNTHROID to treat Hashimoto's disease. Prior to treatment the patient's mother called to discuss the association of fatigue to GARDASIL since it was mentioned as a side effect which may require medical intervention. It was reported that the patient did not have any laboratory tests or reports from the endocrinologist. At the time of the report the patient's fatigue and Hashimoto's disease persisted.  The event of fatigue and Hashimoto's disease were considered to be an other important medical event. Additional information has been requested.
Staff member spoke with Infection Prevention on 10/2/2019 at 1105 am to report that she developed a rash on her chest and that she had an itching sensation on her face starting around 5 pm on 10/1/2019 after receiving the flu vaccine.  No respiratory concerns reported, no medications taken for rash per report.  Advised to contact her health care provider to document the event and to seek medical care if condition worsens.
Within minutes after getting Pediarix, Hib and Prevnar pt broke out with red urticaria. 1cm x 2cm itchy rash and started to hurt and blanch (blanching broke). We gave Benadryl by 10mg, later the rash was fading with Benedryl after 20 mins.
5-19-21 11am extreme pain in shoulder of left arm. The pain got worse throughout the day.  5pm pain started to move up the left side of my neck and down the left side of my back to where I couldn?t turn.  5-20-21  4am pins and needles, aching, chills, muscle cramps throughout entire body Extreme nausea  12:00pm really bad chills again, Pain throughout entire body hurting, skin down lower back, butt and the back of thighs were very sensitive to touch, fever of 102, lethargic, dizziness. Fever lasted all day  2pm same symptoms as 12pm, as well as vomiting