chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pneumonia; did not receive second dose; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PNEUMONIA (pneumonia) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history information was provided by the reporter.  Concomitant products included METFORMIN HYDROCHLORIDE (MEFORMIN) for an unknown indication.    On 13-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 PNEUMONIA (pneumonia) (seriousness criteria hospitalization and medically significant) and PRODUCT DOSE OMISSION ISSUE (did not receive second dose). At the time of the report, PNEUMONIA (pneumonia) and PRODUCT DOSE OMISSION ISSUE (did not receive second dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Apr-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication includes Pills for the stomach,Pills for blood pressure.  Patient was scheduled for second shot on 10APR 2021 but as she got tested COVID positive on 05APR2021, she could not take the second shot. Patient did not developed symptoms but since her son tested positive, she went ahead and got tested. On her daughters recommendation she got admitted into a hospital  received medication for COVID-19, pain, Oxygen and vitamins. She spent 1 day in the hospital and feeling well now.  Company Comment: Very limited information regarding the events has been provided at this time.  Further information has been requested.   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: Follow-up received on 13-may-2021 with additional information in the TCR form; Sender's Comments: Very limited information regarding the events has been provided at this time.  Further information has been requested.
10 days after my 3rd booster. I began having symptoms of hives and shortness of breath. the hives began in my armpits and groin area. I went to urgent care and received a medrol dose pack. over the next couple days the hives spread over my whole body and I began to get angioedemia of my lips and swelling in my hands. I went to the emergency room and received albuterol and more steroids. then I followed up with my PCP, began ongoing antihistamines, diphenhydramine, loratidine, and ranitidine. I was refereed to an allergist who prescribed me an epipen, then to an oncologist for urther testing.  over the next week I developed histamine hypersensitivity (possible mastocytosis) with skin writing. the symptoms persisted and began to ween over 6 months. today I am 100% back to normal.
Swelling, tenderness, redness of left shoulder started evening of 11/21/13 and progressed until visit 11/22/13.  A single clear fluid filled vesicle appeared also AM 11/22/13.
This spontaneous report was received from a physician via a company representative concerning a male patient of unknown age. No concurrent conditions or medical history were reported. In approximately 2012, reported as "approximately 3 years ago" the patient was vaccinated with a dose of VARIVAX (dose, Lot No., route and anatomical location of administration were not reported). No concomitant therapy was provided. In approximately 2013, reported as "one year after vaccination", the patient developed a rash on one leg. The physician had seen the patient in her office on an unspecified date and diagnosed the patient with contact dermatitis. One month later, the patient also developed ulcers on his tongue and the leg rash was still present. The patient was then seen by an unspecified dermatologist on an unspecified date and diagnosed with shingles. The symptoms lasted for approximately 1 month and had then resolved. No Product Quality Complaint (PQC) was involved. The outcome of dermatitis contact and herpes zoster was reported as recovered on unspecified date. Additional information has been requested.
Pounding heart, rapid heart rate, went to walk in clinic for EKG. Showed "scary fast" heart rate.  Taken to ER, EKG, IV's 6 mg Adenosine administered, no effect Cardizem administered with good effect.
Shaking for 3-4 minutes, stiffness and responsiveness, spitting up. 2 episodes - resolved spontaneously.
This case was reported by a pharmacist via call center representative and described the occurrence of leg pain in a 66-year-old male patient who received SHINGRIX (batch number P3777, expiry date 30th January 2020). Previously administered products included SHINGRIX with an associated reaction of pain in extremity (received 1st dose on 7th December 2017 and experienced leg pain. Refer case US2018046735). Concurrent medical conditions included diabetes mellitus and Cerebrovascular accident. On 7th March 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. In March 2018, less than a day after receiving SHINGRIX, the patient experienced leg pain (serious criteria disability) and activities of daily living impaired. On an unknown date, the outcome of the leg pain was not recovered/not resolved and the outcome of the activities of daily living impaired was unknown. It was unknown if the reporter considered the leg pain and activities of daily living impaired to be related to SHINGRIX. Additional details were reported as follows: The healthcare professional reported that no concurrent vaccines were administered. Approximately within 24 hours of vaccination, the patient experienced pain. He reported less than a month after vaccination, had interference with activities of daily living at the time of reporting. The patient reported a pain intensity of 5 out of 5. This case has been linked with case US2018046735 (same patient) for 1st dose.
EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a pharmacist concerned a 27 year old of unspecified sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, expiry: 30-JUN-2021) dose was not reported, administered on 02-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-JUN-2021, the subject experienced expired vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine administered was not reported. This report was non-serious. This case, from the same reporter is linked to 20210604979.
TINITUS BOTH EARS. RINGING SOUND WORST IN MORNINGS. AFTER ALMOST A YEAR STILL SAME. DOCTOR SAID NOT WAY TO IMPROVED OR FIXED THE EARS.
Employee described having malaise and body aches the day after vaccination (1/13/21). The symptoms were severe enough to keep the employee home from work to recover and rest for 1 day.
No adverse effects. Patient was under the age of 60 and received this vaccine which is only indicated for 60 and older.
Patient previously given 2 Moderna COVID immunizations. Dose #3 bivalent COVID-19 pfizer on 4/3/23. No treatment provided. No adverse clinical outcome aside from Pfizer bivalent 3rd dose given to patient with 2 previous COVID-19 immunizations from Moderna.
About 15 min after imms, pt developed "red patches" on left thigh near to where vaccine was given and in the right side of the back of the neck. Red patches looked flat, irregular symmetry. Baby was alert, no crying, regular breathing.  Mom later described the "red patches" as hives on 9.26.19.  Unsure how long hives remained on baby's body d/t unable to reach mom via phone after incident.  No hospitalization was required. Baby's doing well.
Full Hearing loss in left ear the next day after receiving the 1st shot. Also light headed as if my head was full of helium.
The evening after the second shot I woke up achy.  Took ibuprofens and went back to sleep.  The next day I was very tired.  Got fever of 100.1 and chills  at  around 2:00pm.  Headache at 4:00.
I started to feel like I needed to clear my throat all the time. I was coughing so much that I pulled a muscle in my chest and it was very painful. I had GI problems for a month. I had some fatigue for about two weeks. I was tested for COVID-19 on 08/01/2021. I have still been experiencing the dry cough after a month, but the other symptoms have cleared up.
No additional adverse events reported; Customer reporting the administration of improperly stored PROQUAD.; This spontaneous report was received from a customer referring to a patient of unknown age and gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.     On 11-APR-2022, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(rHA)(PROQUAD)0.5 milliliters, lot number U039262, expiration date 09-JUN-2023 (route of administration not reported) for prophylaxis (product storage error). No adverse event was reported.  The vaccine underwent a temperature excursion of 45 degrees Fahrenheit for 3 hours and 45 minutes. No previous excursions were detected.
had swelling all the way up her arm and to her shoulder and to the shoulder blade and almost down to the elbow; hematoma; hot and its feels like a line a fire into her palm where it was on the nerve; The second dose, the caller was down for about three days.; Second dose:  extreme nausea ; Second dose: extreme headache ; Swelling at the injection site; This is a spontaneous report from a contactable female consumer (patient) reported for herself. A 57-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0178, Expiration date: unknown), via unspecified route, administered in left arm on 27May2021 (at the age of 57-year-old) as 2nd dose, single dose for COVID-19 immunisation. patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW976, Expiration date: unknown), via unspecified route, administered in right arm on 06May2021 (at the age of 57-year-old) as 1st dose, single dose for COVID-19 immunisation. The patient medical history includes ulcer. Concomitant medications were not reported. The patient historical vaccines include allergy shots and she experienced swelling as a reaction. The swelling happened after every allergy shot, she ever had, this was 20 years ago. The swelling would start about a day later. The caller would get one allergy shot on a Monday and then one shot on a Friday. The caller also explained he was diagnosed in the fall of 2020 and the caller cannot take Ibuprofen because of this. On 27May2021, after the vaccination, the patient experienced vaccination site swelling, had swelling all the way up her arm and to her shoulder and to the shoulder blade and almost down to the elbow. The swelling is very raised and hot and it felt like a line of fire into her palm where it was on the nerve. The caller thinks it's a hematoma now. The swelling is now the size of an egg in both shape and depth on 29May2021, patient experienced headache and nausea for 2 days.  On an unspecified date patient also experienced feeling down for 3 days. The reporter assessed all events as non-serious. The caller explained he will not get the booster vaccine if Pfizer offers it. also explained that Swelling at the injection site has improved and now it is down to the hematoma the size of an egg. The hematoma is sitting on a nerve and the only thing the caller can do is ice it until it goes away. The outcome of the events mentioned as vaccination site swelling recovering. Nausea, headache and fatigue recovered on 31May2021 and the outcome of peripheral swelling and burning sensation was unknown.  No follow-up attempts possible. No further information expected.
had the flu twice; Initial information received on 14-Dec-2020 regarding an unsolicited valid non-serious case received from a consumer via social media.  This case involved Adult patient who had the flu twice (influenza), while he/she received vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, (latency unknown) patient developed a non-serious flu twice (influenza) after the administration of INFLUENZA VACCINE.  No laboratory data was reported.  It was not reported if the patient received a corrective treatment.  The event outcome was reported as Unknown.  There will be no information available on the batch number for this case.
This spontaneous report was received from a consumer, who was the patient's mother and refers to a 3-year-old female patient. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On an unknown date, the patient was vaccinated with VAQTA dose 1, lot # 1068AA, expiration date: 09-MAY-2014 for prophylaxis (strength and route of administration were not provided). On an unknown date (reported as immediately after receiving VAQTA, the patient had a "dazed look" and did not respond to her name or act normal. On an unknown date (reported as: "after 30 minutes"), the patient recovered from the events. The causal relationship between the events and VAQTA was not provided.
Bottom lip started welling  same day of vaccination and it stop on its own the same day and exactly 2 weeks later my right side of  the face began swelling I went to the ER and my whole face was swollen face inside my mouth. they said I wasn't anaphylaxis I .was given steroids and anhistamines and Pepcid. They tested me for autoimmune disease ANA came back positive and endocrinologist did a US thyroid and everything was normal and he changed my medications and vitamin D and I saw an RA specialist. they did x rays on my hands and they did ANA and it came back negative. after 18 days it started disappearing.
PT SAID HER WHOLE LEFT ARM WAS SWOLLEN, RED PATCHES, ROUND CIRCLES, AND KNOTS AROUND THE INJECTION SITE..PT SAID SHE COULD NOT LIFT HER ARM BECAUSE TOO PAINFUL.
EMPLOYEE DID NOT HAVE INITIAL REACTION AFTER 15 MINUTES OF RECEIVING VACCINE. EMPLOYEE COMPLAINED OF ADVERSE SYMPTOMS TO STAFF APPROXIMATELY 2-3 HOURS LATER. NO VAERS COMPLETED AT TIME. EMPLOYEE STATED TO MANAGEMENT 11/26/2014 THAT SHE DID NOT WISH TO RECEIVE ANOTHER VACCINE DUE TO HAVING A REACTION FROM THE PREVIOUS. EMPLOYEE STATED THAT AFTER VACCINE WAS GIVEN ON 10/20/2014 SHE EXPERIENCED SLIGHT SWELLING IN HER HANDS, ARMS, AND FACIAL AREA. EMPLOYEE STATED THAT SHE WAS ADVISED TO TAKE SOME BENADRYL AFTERWARDS SHE STATED THE SYMPTOMS SUBSIDED ABOUT AN HOUR AFTER.
Got the vaccine, and a few hours later started getting tingling on her lips.  Later that night she started getting fever blisters, low grade fever and  nausea, left sided face swelling inside and out.     She has fever blisters in her mouth, and her lower lip is also being affected.  The lower lip still has the blisters/bluish color for them.   She is taking Lypsyl ointment to keep her lips moistened.   She called her doctor and prescribed her Valacyclovir, which did not help at all.  She was on it 7 days.  She went back to her PCP and told her that it did not work, and could not believe it didn't work, so is not on anything at this time.
I have taken both shots./ I am in an isolated room for 14 days.; asymptomatic, but came up with a positive reading; This is a spontaneous report from a contactable consumer (patient) via a Pfizer sponsored program. An 84-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first (Batch/Lot number was not reported)  and second dose (Batch/Lot number was not reported); both via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient reported that he have taken both shots, his temp range has been between 97.2 to 98.4 and was asymptomatic, but came up with a positive reading. He was in an isolated room for 14 days. The patient underwent lab tests and procedures which included body temperature: between 97.2 to 98.4 and SARS-CoV-2 test: positive both on unspecified dates. The outcome of the events was unknown.
Initial unsolicited report received from Health Care Professional on 18 Dec 2018. This case involves five-year-old patient who was vaccinated with 0.5 ml fourth dose of PENTACEL (Batch number: C5553AA, expiration date: 10-Oct-2019, dose, route was not reported) in left deltoid (frequency once) on 18-Dec-2018. The patient's medical history and concomitant medications were not reported. No other vaccines. It was an actual medication error due to inappropriate age at vaccine administration. Caller reported that a 5 year old received their fourth dose of PENTACEL today and wants to know how to proceed. It was unknown if patient had adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance 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. List of documents held by sender: none.
Patient first experienced headache and posterior neck pain that lasted approximately 48 hours.  Following that he developed severe cervical neck pain that lasted 1.5 hours.  The pain then traveled down his spine and was accompanied by allodynia, both of which lasted approximately 48 hours.  By the afternoon the patient experienced pain and allodynia all down his back, into the posterior of his legs, throughout his hips, and into his knees.
This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Arm was sore for couple days), MASS (Week later, lump 4 inches lower than the injection site.), CONTUSION (Dark bruise appeared / Bruise got bigger), PRURITUS (Itchy) and ERYTHEMA (Red) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included ACETYLSALICYLIC ACID (ASPIRINE) and LEVOTHYROXINE SODIUM (LEVOTHYROXIN) for an unknown indication.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, the patient experienced PAIN IN EXTREMITY (Arm was sore for couple days). On 04-Feb-2021, the patient experienced MASS (Week later, lump 4 inches lower than the injection site.), CONTUSION (Dark bruise appeared / Bruise got bigger), PRURITUS (Itchy) and ERYTHEMA (Red). At the time of the report, PAIN IN EXTREMITY (Arm was sore for couple days), MASS (Week later, lump 4 inches lower than the injection site.), CONTUSION (Dark bruise appeared / Bruise got bigger), PRURITUS (Itchy) and ERYTHEMA (Red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The treatment information was not provided.   This case was linked to MOD-2021-035259 (Patient Link).
Patient was given a dose of Pfizer vaccine at 0900 this AM.  The vaccine was not diluted.  Patients mother notified.  Patient has had no adverse event from dose.
Burning hip; Pain/Sore; Cannot sleep; Burning pain in her left buttocks and hip; pain as burning and hurts if cold touches it like someone hit her in the leg; Burning pain in hip; This non-serious case was reported by a consumer via call center representative and described the occurrence of burning sensation in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in October 2022, in left arm, at the same vaccination facility).   In MAR-2023, the patient received the 2nd dose of Shingrix (left arm). On an unknown date, several weeks after receiving Shingrix, the patient experienced burning sensation (Verbatim: Burning hip), pain (Verbatim: Pain/Sore), sleeplessness (Verbatim: Cannot sleep), buttock pain (Verbatim: Burning pain in her left buttocks and hip), leg pain (Verbatim: pain as burning and hurts if cold touches it like someone hit her in the leg) and pain in hip (Verbatim: Burning pain in hip). The outcome of the burning sensation, pain, sleeplessness, buttock pain, leg pain and pain in hip were not resolved.   It was unknown if the reporter considered the burning sensation, pain, sleeplessness, buttock pain, leg pain and pain in hip to be related to Shingrix.     It was unknown if the company considered the burning sensation, pain, sleeplessness, buttock pain, leg pain and pain in hip to be related to Shingrix.   Additional Information: GSK Receipt Date: 31-MAY-2023 The patient self-reported this case. The patient reported the administration of second Shingrix vaccine dose in 2nd week of March 2023 after the couple of weeks she started having a burning pain in the front of her left thigh, and in her left buttocks and hip. The patient described the pain as burning and hurts if cold touches it like someone hit her in the leg. The patient reported this burning pain stayed continuously all day and night; and she could not sleep. During the day it was so sore. Till the time of reporting, the patient had this burning pain. Consent to follow up with healthcare professional was obtained but reporter did not know any of the physician information and could not provide it. The reporter consented to follow up.
multiple tight tender vesicular lesions on hands, elbows, knees, and feet.  Treated with motrin and was excused from work x3 days because it was uncomfortable for him to wear his work boots