chrisvoncsefalvay/vaers-outcomes huggingface dataset:
1st vaccination on 03/28/2019 / 2nd vaccination was not administered; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 28th March 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The patient was in pharmacy on 19th October 2021, but did not receive 2nd dose of Shingrix on 19th October 2021. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination The reporter consented to follow up.
Left upper edema, redness, hot to touch. Pt denies pain. No pain with palpitation, adm 7/24/03. Mother tx with Tylenol. Pt is alert and active. Recommend ice, children's Motrin, elevate arm.
This spontaneous report has been received from a patient's mother and refers to a 4-day-old non-pregnant female patient. The patient had no concomitant medications, pertinent medical history and drug reactions or allergies. In January 2009, the patient was vaccinated with RECOMBIVAX HB lot # 662390/1039X, dose 1, intramuscularly (dose and expiration date were not reported). On an unknown date, the patient experienced jaundice. A bilirubin test and blood work was given and the patient had elevated high numbers (no specific or other symptoms were given). It took about six weeks to reach a "normal reading". No specific number ranges were provided. No subsequent doses were received. The reporter stated that the patient was 8 years old at the reporting time and has since recovered. No product quality complaint was involved. The reporter requested a total number of manufactured doses of this particular lot #. The outcome of jaundice was reported as recovered (unspecified date). The relatedness between the event and RECOMBIVAX HB was not reported. Additional information is not expected because there was no consent to contact the patient's physician.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. No pertinent medical history or drug reactions/allergies were provided. The registered nurse reported that, on unknown dates, an unspecified number of improperly stored VARIVAX (Merck) INJ doses had been administered to patients (lot numbers and routes not provided). No adverse effects were reported. Additional information has been requested.
Starting in 10/2022, I developed balance issues when I would kneel down causing me to fall onto my back. My legs were very weak and wobbly and I am unable to walk like I normally would. Also, my left and right leg seem to be out of sync. I seem to be falling more frequently from a standing position while walking. No dizziness, no blackouts, no vertigo just weakness causing me to collapse. The right leg seems unaffected and I seem to lean towards the weak leg (left) causing me to not stand up straight. After my falling became frequent, I called my doctor at the hospital who told me I should go to the ER for a CT scan and tests. When I went, the CT scan was normal but told me to get an MRI. I was unable to get one in the ER so I am currently looking for a doctor who can order an MRI for me because if I get my doctor to order the MRI it will not be honored by a non facility. To note: I was working up on the dosage of the fluoxetine weeks prior to this starting and once I reached the max 60mg dosage the symptoms started coincidently after. I only started the medication in July and slowly increased the dosage every week until the desired dosage was reached (60mg).
Patient had a routine mammogram on March 4, 2021.  She had received her 1st dose of the Moderna vaccine 3 1/2 weeks before in the left arm.  Enlarged lymph glands in the left axilla showed up on the mammogram.  These lymph nodes could not be felt.  There were no enlarged lymph glands in the right armpit. She may need future imaging to see if the nodes go back to normal in the future.
One to two weeks after I received my Pfizer vaccine. I began to notice a rash on both of my hands on the dorsal aspect. It became progressively worse. After my 5th dose of my COVID-19 vaccine it progressively became worse still and ascended up my arms to both forearms to dorsal aspect. It was very inflammatory and red. It responded to MOTRIN and TYLENOL. I put steroids on the rash as well. After biopsy, cultures, and blood results were subacute spongiotic dermatitis with eosinophils. Eczematous Dermatitis and its variant, which seem most likely in this case, drug eruptions, and arthropod bite reactions. I also had a low grade fever for about two weeks of about 99.9 degrees. I had elevated IGE to 537 (history of elevated IGE dating back to 7/2016 secondary to ABPA).
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021 at 3:32 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Mar-2021 at 3:32 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was reported as 69.48.  Concomitant products were not provided.  Vaccine was moved to fridge on 24-Feb-2021 and was moved to clinic on 03-Mar-2021. 20 vial was sent to clinic.   For Lot no : 014M20A on 03-Mar-2021, excursion time was 9 AM, 10AM and 1 PM and temperature was 51, 34 and 35 respectively, total doses given for the day was 200, condition of vaccine prior to vaccination was not frozen.   For Lot no : 014M20A vial was stored on cooler 1 , on 03-Mar-2021, Excursion duration At 9 AM: 51, 10 AM: 34, 11 AM: 44, 12 AM: 46, 1PM : 35, 2 PM : 36, 3 PM: 36, 4 PM: 36.  Vaccine BUD date was 26-Mar-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a Fisherbrand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.   This case was linked to MOD-2022-566976 (Patient Link).
Pt recv vax on 10/15/97; on 10/16/97 pt exp unable to hear (75% loss) in left ear/ nerve damage; tx=Prednisone; Annual follow-up dated 2/21/01 provided no additional data.
On February 1, 2021 after getting my second dose of Moderna on 1/27/2021 I broke out with a red, hot, raised, itchy rash at the site of injection.  It was approximately 3 inches long by 3 inches wide.  This rash lasted for about five days until completely gone.  The first two days the rash was very itchy and when my clothing touched the rash it irritated more.  I took Benadryl to relieve the itching.  This seemed to help greatly.  After the first two days I didn't have to take the Benadryl the itching was tolerable.  By the fourth and fifth day I cold barely notice the rash anymore.  I didn't need to be seen for this as it went away on its on.
Patient received varicella vaccine on 8/1/2022 and developed a rash on 8/2/2022.  No fever, swelling, or respiratory symptoms.
Information has been received from a physician concerning a 2 month old female who on 8/26/06 was vaccinated PO with a 2.0 ml dose of Rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human Bovine) along with other vaccinations (vaccines unk). The physician reported since 8/26/06 the pt has had seven cases of diarrhea as of 9/5/06. Unspecified medical attention was sought. The pt had no weight loss and was noted to be afebrile. At the time of this report, the pt had not recovered. Additional information has been requested.
Pain in (R) arm from injection site to elbow. Constant pain increasing with movement. Pain onset 1/2 hr after injection "leveling off" 3 hrs later. Client referred to PMD for assessment.
But when I went back to get second they said I already had 2 so I argued I didn't then that night I started having issues. Breathing sleeping heart racing feeling like going to faint rushing to ER every other day for inflammation shot in my chest and heart lost my job yawning tired all the time just got COVID and hearts inflamed again have two kids 10 n 8  since then my heart hurts frequently and all summer did and tired all the time
LYMPH EDEMA, FEVER, SHAKING, CHILLS, LEFT FACIAL NUMBNESS, VERTIGO, NAUSEA, FATIGUE, LOWER BACK PAIN, JOINT PAIN, ELEVATED ALT 39
This spontaneous report was received from a physician via company representatives and from a support services director concerning to a patient of unknown age and gender. Information about the patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications was not reported. On 09-FEB-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23, which had the lot # K009874 with expiration date 19-MAR-2016 (dosage number and route of administration were not reported). On an unspecified date, the vaccine had a temperature excursion for 24 hours in which the lowest recorded temperature was 34 degrees Fahrenheit (1.111111111 degrees Celsius). The vaccine status was reported as "in excursion". The vaccine storage criteria and type were reported as "refrigerator (R)". No adverse effects were reported and no product quality complaint was involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Pain at injection site (primarily right arm), flu-like body aches, chills; symptoms grew worse over a 12-hour period, and then gradually lessened over the next 12 hours and were non-significant after 24 hours  Did NOT experience headaches, upset stomach, or dizziness
Nursing requested a Hep A vaccine from pharmacy and the pharmacist mistakenly handed the nurse a adult Hep A dose to the nurse and the adult dose was administered. There are no reported side affects.
AFLURIA administered at approx. 4:00 PM on 10/25/10. Patient's mother called pharmacy at approx. 7:30 PM to report hives on pt's legs... not injection site. Vaccine administrator told patient's mother to start oral BENADRYL and to go ER if symptoms worsened or pt developed S.O.B. Also advised follow-up with primary care physician in the morning.
This spontaneous report was received from a consumer regarding her 14 year old grandchild (gender unspecified). Approximately on an unknown date in December-2011 (reported as 1 year ago), the patient was vaccinated with dose 1 of GARDASIL, (lot number, expiration date and route not reported). No concomitant medications were reported. Approximately on an unknown date in March-2012 (reported as 9 months ago), the patient experienced severe, debilitating headaches. The patient has had a series of laboratory tests. The patient sought medical attention. She had consulted neurologist, gynecologist and allergist. On an unknown date in 2012, the patient has had sinus surgery and to date there has not been any resolution to the symptoms. The outcome of the events was reported as not recovered. Additional information is not expected.
Shivers, chills, mild fever. Aches all over. Joint pains. Time of adverse events 48 hours except for arm ache and fatigue 5 days.
The dose for the Moderna vaccine is .5 mL. This patient inadvertently received an overage of 0.01 to 0.02 mL. The manufacturer instructed us to contact the patient to inform them that the increased dosage could potentially lead to side effects that could be local or systemic. No serious adverse events were reported by the patient.
This case was reported by a consumer via call center representative and described the occurrence of chills in a adult patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of malaise (1st dose received few months ago from the reporting and experienced temperature, chills, muscle aches, joint pain). On 18th March 2019, the patient received the 2nd dose of SHINGRIX. On 18th March 2019, 10 hrs after receiving SHINGRIX, the patient experienced chills, fever, muscle pain, joint pain, headache and restlessness. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the chills, fever, muscle pain, joint pain, headache and restlessness were unknown. It was unknown if the reporter considered the chills, fever, muscle pain, joint pain, headache and restlessness to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The age group was not provided, but was selected adult as per the vaccine indication. About 10 hours later the patient had a temperature of 101, chills all night, muscle and joint aching and a headache. On 18th March 2019, lab test was performed. The patient tried to sleep but just tossed and turned 1 sheet, 1 blanket, 2nd blanket and stayed in sweat pants and long sleeve tee shirt and still shook. On the day of reporting, the patient was dragging and had a headache. The pharmacists did not know about the side effects or they were not very forthcoming about it.
Man reported by phone patient has had hives since evening of vaccines.  Treated with one dose BENADRYL at time of call.  Mom reports possible later unconfirmed allergy as infant.   Mom refused office evaluation.
Muscle twitches, elevated heart rate, chest pain, numbness/tingling (from vaccination to present)
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 27-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 27 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 27Feb2021 as dose 1, single (Batch/Lot number: unknown), in left arm and on 23Mar2021 as dose 2, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "generalized anxiety" (unspecified if ongoing), notes: other medical history: generalized anxiety; "adrenal fatigue" (unspecified if ongoing), notes: other medical history: adrenal fatigue; "acid reflux" (unspecified if ongoing), notes: other medical history: acid reflux; "not immunocompromised but weak immune system historically" (unspecified if ongoing), notes: other medical history: not immunocompromised but weak immune system historically; "overweight" (unspecified if ongoing), notes: other medical history: overweight; "Pfizer BioNTech Dose number:3/Moderna Dose number:2/ Moderna Dose number: 1" (unspecified if ongoing), notes: Pfizer/BioNTech Dose number:3/Moderna Dose number:2/ Moderna Dose number: 1. Concomitant medication(s) included: MICROGESTIN, start date: 06Feb2014; NYQUIL, start date: 05May2022, stop date: 18May2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 05May2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (05May2022) Positive; (11May2022) Negative, notes: tested negative day 6-11May-14May; (12May2022) Negative, notes: tested negative day 6-11May-14May; (13May2022) Negative, notes: tested negative day 6-11May-14May; (14May2022) Negative, notes: tested negative day 6-11May-14May; (16May2022) Positive. Therapeutic measures were taken as a result of covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Client reported feeling as though she may faint. Client's HR initially elevated upon assessment at HR of 120. Client stabilized. She reported that she became anxious because she lied and this was actually her 3rd covid vaccine. She had received 2 doses of Pfizer previously.
This spontaneous report was received from a nurse practitioner, referring to a 28 year old female patient. The patient had drug reactions or allergies to penicillin, cephalexin (KEFLEX) and to sulfanilamide (SULFA). On 19-APR-2018, the patient was vaccinated with GARDASIL 9 injection, expiration date in 29-APR-2020 (strength, dose, frequency, administration route and lot number were not reported), for prophylaxis (reported as "vaccination"). Concomitant therapies included an unspecified birth control pill. On 07-MAY-2018, the patient reported to the nurse practitioner, having bruising at the injection site and all over her body (injection site bruising and contusion), which started on an unspecified date in 2018. The patient reported the bruising as significant disability. Lab diagnostics or studies were not performed and treatment was not given. The outcome of contusion and injection site bruising was reported as not resolved. The causality assessment between GARDASIL 9 and the aforementioned events was not provided. The patient considered contusion and injection site bruising to be serious due to significant disability.
red, swollen & warm arm; area of redness 8cm x 5cm; 10MAY93 seen 23APR93; area <4cm following tx w/warm compresses & Advil;
Headache and high fever next day. Symptoms subsided within 24 hours. Treated with Tylenol.  5 days after, itchy hives all over, treated with Benadryl and cortisone cream.  Severe Leg and foot swelling (left leg). Treated with steriod regemin
Client got lightheaded when changing position from sitting to standing. SN noted client kneeled on all fours and laid on floor.  He become confused and verbally non responsive. His breathing was irregular on our assessment. On arousal patient started to respond after 30-40 seconds. His speech was garbled and delayed and patient was aware that he had fainted.  He admits to a history of fainting in the past at work. He was able to walk to observation bay to lay down for approximately an hour.  Paramedics were called at the beginning of episode. Bp 129/78, Pulse 78 Resp16, O2 sat 98% temp 32 C temporal He rested in bay about a hour and was transported home via car by wife after refusing transfer to hospital by paramedics
Itching swelling - 4inches x 5inch in size hard-painful - vomited x2 during the night- Flushed - did not check temp @ home.
One day after my shot I started feeling flu like symptoms. I was tired, lethargic, nauseous, and I had zero energy. I also had a lack of appetite. I did take Zofran 4mg PRN after about two days the symptoms subsided. On the second day I noticed I had a large lump under my left armpit. It didn't go away for a few days so I did make an appointment and my Doctor stated it was just a reaction to the shot and the lymph node would go down. It did eventually go away after about one week.
fatugue; Itchy in her upper trunk area; prickly in her upper trunk area; eyes dry; mouth dry; lips dry; ears were burning; redness; Rash on upper torso; watery eyes; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of PRURITUS (Itchy in her upper trunk area), MILIARIA (prickly in her upper trunk area), DRY EYE (eyes dry), DRY MOUTH (mouth dry) and LIP DRY (lips dry) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced ERYTHEMA (redness), RASH (Rash on upper torso) and LACRIMATION INCREASED (watery eyes). On 12-Feb-2021, the patient experienced PRURITUS (Itchy in her upper trunk area), MILIARIA (prickly in her upper trunk area), DRY EYE (eyes dry), DRY MOUTH (mouth dry), LIP DRY (lips dry) and BURNING SENSATION (ears were burning). On 13-Feb-2021, the patient experienced FATIGUE (fatugue). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form. On 12-Feb-2021, PRURITUS (Itchy in her upper trunk area), MILIARIA (prickly in her upper trunk area), DRY EYE (eyes dry), DRY MOUTH (mouth dry), LIP DRY (lips dry) and BURNING SENSATION (ears were burning) had resolved. On 14-Feb-2021, FATIGUE (fatugue) had resolved. At the time of the report, ERYTHEMA (redness), RASH (Rash on upper torso) and LACRIMATION INCREASED (watery eyes) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications included blood pressure pills and B12 shot.   Most recent FOLLOW-UP information incorporated above includes: On 08-Mar-2021: Event was added -Rash on her upper torso, dry mouth, watery eyes, and redness.Added pregnant status also as NO.Added Anatomical location as RIGHT ARM.Added reporter details also -Address, email, city, state, postal code, occupation, reporter type.Added secondary reporter details also-Address, phone number, city, state, postal code. On 15-Apr-2021: NNI
At approx 6:30 pm - decreased back pain when to muscle spasms in hands/ feet, joint pain, chills with teeth chattering.  Temp increased 102s.  On 05/09/01 - Temp decreased 101 degrees with tylenol and discomfort.
Fever, body aches x one night. Right arm muscle twitching intermittent x 6 days s/p vaccination. Vaccine was given in left deltoid.
Patient experienced fevers, slight chills, and a sore, red hardened area (roughly 5" in diameter) at and surrounding the vaccine site injection. General malaise and soreness of the arm lasted several days- a week. Still experiencing some malaise.