chrisvoncsefalvay/vaers-outcomes huggingface dataset:
24 hours, post vax, she developed a fever that was gone after 48 hours, had body aches, diarrhea and dehydration. All were gone after 24 hours but still has 3 X 3 red and hot local area as of 7/29/00.
This spontaneous report was received from a registered Licensed Practical Nurse and refers to an unspecified number of patients of unknown age and gender. The concurrent conditions, medical history and concomitant medications of the patients were unknown. On unknown dates, the patients were vaccinated with"one or two" improperly stored doses of PNEUMOVAX 23 lot # N025563, expiration date 08-APR-2019 for prophylaxis (strength, dose number, anatomical location and route of administration were not reported). The administered vaccines had temperature excursion below 36 degree Fahrenheit  (°F) (32F) for 4 hours and 48 minutes, additionally there was a previous temperature excursion  below 36°F (33.8F) for 1 hour  and 40 minutes. The called was because a digital data logger.
A consent form to receive the COVID-19 vaccine was returned to the school for a COVID-19 vaccination. The vaccination was provided by a nurse. The consent form was completed with the child's correct name and date of birth. The family turned it in pre-emptively to have the child vaccinated when she turned 12 next spring. Patient was administered vaccine, during a period where it is yet approved for her age group. No adverse outcomes for child - medically stable.
The first day after, my left arm was very painful and unusable, and I was very exhausted. This subsided over the week until 8 days after when it started to become red and itchy. Two days after this started, I took a shower and my entire upper left arm was red with a very defined rash (a circle around the injection site with a fully red oval extending underneath) and still very itchy which has continued through this week. The redness is still there and itches randomly. No treatment has been done and I have images to demonstrate this.
Legs started itching after 1 day Arms and body started itching day 2 Lymph nodes starting swelling day 2  Itching still remains as does the swollen lymph nodes
PT was seen for nounal reaction to vax and viral URI and noticed approx 11 erythematous raised lesions like a wheal about 2-4 mm in site on abdomen - asympt.
Systemic: Dizziness / Lightheadedness-Medium, Systemic: Flushed / Sweating-Severe.
regular patient of pharmacy came in on 09/21/19 to receive her yearly flu vaccination. We are aware of and patient disclosed diagnosis of epilepsy and states that she has always received her influenza vaccine and has never had an issue. Vaccine was administered with no difficulty. After patient ambulated she began to speak to the pharmacy staff about various topics. After approximately 5 minutes she proceeded to fall to the ground due to a seizure. Patient was turned on her side and kept safe while an ambulance was called. After approximately 5 minutes, patient became conscious and was kept seated and calm until paramedics arrived. They took over care and took her to a local hospital. Patient called 60 minutes later inquiring as to the details of what happened and asking for her complete med list to provide to the ER staff.
Approximately 7 hours after injection, noted soreness at site followed by severe discomfort down entire left arm and inability to use hand or fingers without pain. This persisted throughout the night; I took Aleve (220 mg. Naproxen sodium) followed by 1 Extra strength Tylenol about every 2 hours during the night.  I had to use my right arm to move my left arm trying to find a comfortable position.  There was no swelling or redness at the site.  I also was experiencing sharp jabbing pains in my right leg, but have no idea if this was related.  There is some abatement of the pain at this time, which is 21 hours after injection and I am able to use my fingers, but raising the upper arm is still painful.
sore; This spontaneous case was reported by a patient and describes the occurrence of PAIN (sore) in a 79-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     Concomitant products included LEVOTHYROXINE and CARBAMAZEPINE for an unknown indication.    On 08-Oct-2023, the patient received fifth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 09-Oct-2023, after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced PAIN (sore). The patient was treated with NAPROXEN at an unspecified dose and frequency and ASPIRIN [ACETYLSALICYLIC ACID] at a dose of 2 aspirins. At the time of the report, PAIN (sore) had not resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   On 04-Mar-2021, patient received 1st dose. On 01-Apr-2021, patient received 2nd dose. On 03-Dec-2021, patient received 3rd dose. On 21-Nov-2022, patient received 4th dose.  On the day of vaccination, in afternoon and evening, patient did not feel any soreness in the arm nor anywhere else. Next morning, patient was sore, and stated about never being this sore.   This case was linked to US-MODERNATX, INC.-MOD-2023-744962 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-744962:Bivalent dose
PATIENT COMPLAINED OF NAUSEA AND VOMITING ON AND OFF FOR 3 WEEKS SINCE HIS FIRST DOSE.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Apr2021 as dose 1, single (Lot number: EWO150), in left arm, on 30Apr2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 07Dec2021 as dose 3 (booster), single (Lot number: 33030BD), in left arm and on 29Jun2022 as dose 4 (booster), single (Lot number: FM7553) at the age of 59 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "underactive thyroid" (unspecified if ongoing); "known allergies: Sensitive to some antibiotics" (unspecified if ongoing), notes: known allergies: Sensitive to some antibiotics. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Dec2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Lips swollen top left and bottom right. Took a 12 hour Allegra and Ibuprofen. The swelling subsided by noon on the 24th.
No additional AEs or PQC reported.; Caller reported expired dose of PNEUMOVAX 23 was administered.; This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, drug reactions or allergies, and concomitant therapies were not reported.  On 19-SEP-2022, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot number T040202 with expiration date 11-SEP-2022 (dosage, route of administration and anatomical location were not provided) for prophylaxis. No additional adverse events (AEs) reported.  Follow up information has been received from pharmacist office concerning to a 74-yearl-old female patient with no known drug allergies. Patient's concurrent conditions included heart disease and hyperlipidemia.  On 19-SEP-2022, the patient was vaccinated with an expired first dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), intramuscularly, 0.5 milliliter, in the left deltoid. This error occurred during product storage in clinical practice. Concomitant therapies included acetylsalicylic acid (ASPIRINE) and atorvastatin.  The patient was notified of the expired vaccine that she received. The patient decided no to return for revaccination.  This case was previously considered non- valid due to lack of patient's identifiers but per current process it was determined to be valid.
Fever like symptoms: Achy, low energy, tired, painful joints, sore head, headache, feeling cold/chill
Booster given at 1PM no issues until 8:30 PM felt ?under the weather? as expected and went to bed?awoke in night and had headache and felt aches and pains in joints and muscles?took Advil gel cap?..slept fitfully due to headache and aches?.woke at 7:30AM Monday morning and same unrelenting headache, aches and pain in joints (couldn?t bend my fingers) and muscles too (flu like symptoms)?.tinnitus was very loud and would pulsate when I got up and walked around?.extreme fatigue, chills, nerve endings agitated causing uncomfortable reaction to touching cold surfaces?pain and swelling developed in right underarm area of arm received vaccination?.fever of 99.7 high for me since I run subnormal temp.  Headache, tinnitus and swelling under arm continued as other symptoms eased? Slept as much as possible on Monday and called my doctor for advise on painful swelling in underarm area on Tuesday.  Advised to take Advil every 8 hrs and call back if did not resolve in a couple of days?.did not ask to see me.
lt deltoid area, SC movable mass 1.3cm diameter @ site of 24JUN96 vax on 8JUL96 & 28JUN96;warm soak ordered;
24 hours post vax, the pt experienced a progressive local erythema, tenderness, induration and heat with headaches which lasted 3 days.
Initial information received on 06-Nov-2018 regarding an unsolicited valid non-serious case received from a health care professional. This case involves a 91 years old female patient who was vaccinated twice with 0.5 ml dose of FLUZONE HIGH DOSE (lot UI981AA and Exp. Date 16-MAR-2019) via intramuscular route in the left arm on 04-Sep-2018 and (lot UJ010AC and Exp. Date 22-APR-2019) via intramuscular route in the right arm on 29-Oct-2018. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to extra dose administered. It was not reported whether the patient had any 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.
5-7 days s/p vax pt devel hives x every evening for 10-12 days, responding to Seldane;
Red, itchy hive at site of varicella vaccine. Pink color about 3 inches in diameter and red center about 1 inch in diameter. Area is gradually getting larger. Diarrhea, tired, achy. No treatment yet.
Patient requested a Janssen COVID vaccine, but was given a Pfizer COVID vaccine by mistake.
Rash Narrative: Pt called w/questions about taking OTC benadryl for a rash that is on her arms and legs and some on her trunk that she reports began last night, five days after receiving dose #1 of the covid vaccine on 12/30/20. Denies any other symptoms at present and is primarily concerned about reporting her rash. No history of anaphylaxis in her medical history or other allergies to food or medications are known to her. Rash appeared scattered to trunk and extremities x4, red, raised, dry bumps that do not itch at present. Agreed that 25-50mg oral benadryl would be a good choice to start, which she states she will do. She in an APRN and states she feels comfortable recognizing new or additional symptoms for which she should seek medical attention, such as difficulty breathing, rapid heart rate, worsening of rash, swelling off her face, throat or lips, or dizziness/weakness. She has family at her home as well and is not alone.
Patient stated he was sent in by nursing home due to being COVID positive. 88% room air and does not normally use oxygen. cough.
product experienced a temperature excursion; no adverse event; This spontaneous report as received from a pharmacist (also reported as costumer) refers to a patient of unknown age. The patient's medical history, concurrent conditions and concomitant therapies were not provided.     On 27-MAY-2021, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot # S028737 expiration date 03-APR-2022 for prophylaxis (strength, dose, frequency, route, lot# and expiration date were not provided).  No adverse effects were reported. Temperature excursion was registered by Digital Data Logger. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S028737; expirationdate: 03-APR-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
Itchiness in my nostrils, itchy skin and head. Itchy ears, neck, back, eyes, arm, and elbows. Palms of my heads were numb, sore throat and wheezing. I had  back, elbow, leg, wrist, and joint pain. Difficulty walking, coughing, chest pain, kidney pain. I was put on Benadryl at the Emergency Room. I used my nebulizer when I returned home.
Vx mixed with different diluent; Vx with different diluent administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 16-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA764A, expiry date 31-DEC-2023) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced wrong solution used in drug reconstitution (Verbatim: Vx mixed with different diluent) and inappropriate dose of vaccine administered (Verbatim: Vx with different diluent administered). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 04-APR-2023 The reporter (medical assistant) called in to report the administration of Menveo that was reconstituted with a different diluent other than the supplied meningococcal CYW-135. The reporter asked how to proceed with the patient. The reporter consented to follow up. At the time of reporting, the patient was administered with Menveo that was reconstituted with a different diluent other than the supplied meningococcal CYW-135, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.
migraine behind the eyes; pain in the teeth; Nausea; A spontaneous report was received from a consumer concerning a 52-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events migraine behid the eyes, pain in the teeth, nausea.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 25 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273  via unknown route for prophylaxis of COVID-19 infection.  On 26 Feb 2021, the patient experienced the event(s) migraine behid the eyes, pain in the teeth, nausea.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), migraine behid the eyes, pain in the teeth, nausea was Not Recovered/Not Resolved.
1 of 3 pt devel welts @ the site of inj w/in 24hr p/vax;
On 5/17 or 5/18, I began to experience a slight runny nose and cough. I was visiting family at the time. My son in law was experiencing some symptoms and was working from home. On 5/21, my son in law went to an urgent care clinic and was diagnosed with Covid. I immediately took an at home Covid test and it was almost instantly positive. I promptly drove to the nearest medical clinic, where I had recently been treated for conjunctivitis. The doctor there prescribed me a round of Paxlovid. My symptoms subsided within 12 hours of the first dose of the antiviral. My wife and I drove home the following Sunday and we were both testing negative for Covid by 05/27.
Patient to clinic with complaints of nausea with vomiting and feeling feverish around 30mins to 1hour after injection.
Information has been received from a physician referring to multiple unspecified patients of unknown age and gender. On unspecified dates in February 2016 (reported as between 15-FEB-2016 and 23-FEB-2016), the patients were vaccinated with doses of improperly stored RECOMBIVAX HB (dose, route, lot # and expiration date were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
6.10.21 Urticaria, HA, fever seen in ER 6.13.21 Treated with drapred & benadryl
Sibling with chicken pox-pt developed pox on 2/26/03, by 2/28/03 he had over 82 pox.
G47.33 OBSTRUCTIVE SLEEP APNEA 5/1/2023 BENIGN PAROXYSMAL POSITIONAL VERTIGO
Bacteremia (Strep. Pneumo) Vaccine failure (possibly) Vaccinated w/ PCV-7 (3 doses) onset 6/17/04.
This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (developed a sore arm) and FEELING ABNORMAL (felt bad for a day after receiving the Moderna COVID-19 vaccine) in a male 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (developed a sore arm) and FEELING ABNORMAL (felt bad for a day after receiving the Moderna COVID-19 vaccine). At the time of the report, PAIN IN EXTREMITY (developed a sore arm) outcome was unknown and FEELING ABNORMAL (felt bad for a day after receiving the Moderna COVID-19 vaccine) had resolved.    No concomitant medications were reported. No treatment information was provided. The patient did not expand on the type of side effects and did not give any further information on this adverse event.
got covid after 3 vaccinations and still got long haul covid; got covid after 3 vaccinations and still got long haul covid; 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 COVID-19 Vaccine - Manufacturer Unknown, as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Fever", start date: Jan2022 (unspecified if ongoing), notes: I have had a fever everyday since January last year. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "got covid after 3 vaccinations and still got long haul covid".  Clinical course: patient was seeking assistance with the medication Prempro. Patient reported had not worked in over a year because had been diagnosed with long haul Covid, and also been diagnosed with fibromyalgia and chronic fatigue syndrome and do not even drive, had got a lot of health issues going on. Patient even got covid after 3 vaccinations and still got long haul covid and have had a fever everyday since January last year. Patient had to have surgery to remove ovaries and everything at 38 years old, and that was not including a double mastectomy after that.  The information on the batch/lot number for COVID-19 Vaccine - Manufacturer Unknown has been requested and will be submitted if and when received.
red rash below injection shot lasted 4 days.  not itchy.  seemed better when woke up in morning, but would turn redder as hours passed each day
severe headaches, joint pain, skin irritation,rash's on chest other parts of torso, not just injection site, sleeping problems, red circular rash around injection site, 5 inchs or so diameter, chills, fever, digestive problems, nausea, lethargy and depression.  PLEASE NOTE, HAD DR. VISIT SAME WEEK, AND WAS PERFECTLY HEALTHY AT TIME OF VISIT!
encephalitis; This case was reported by a consumer via call center representative and described the occurrence of encephalitis in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, 2 days after receiving Shingrix, the patient experienced encephalitis (serious criteria GSK medically significant). On an unknown date, the outcome of the encephalitis was recovered/resolved.   It was unknown if the reporter considered the encephalitis to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported, but it could be 77 or 78 years. The patient took over a year to recover from  encephalitis. The reporter did not consent to follow up. The reporter declined to answer any additional questions.
Next AM headache.  Swelling at site next day- L arm 7cm x 9cm raised swollen tender area with 5cm oval area of erythema.
my left eye was swollen and watering throughout the morning; my left eye was swollen and watering throughout the morning; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14May2022 as dose 4 (booster), single (Lot number: FM9992) at the age of 65 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Drug Allergy" (unspecified if ongoing), notes: Reaction: Allergy. Concomitant medication(s) included: LOSARTAN. Vaccination history included: BNT162b2 (DOSE 3 (BOOSTER), SINGLE, Lot Number: FJ1611), administration date: 19Nov2021, when the patient was 65-year-old, for COVID-19 immunization; BNT162b2 (DOSE 2, SINGLE, Lot number: EW0179), administration date: 03May2021, when the patient was 64-year-old, for COVID-19 immunization; BNT162b2 (DOSE 1, SINGLE, Lot number: EW0151), administration date: 12Apr2021, when the patient was 64-year-old, for COVID-19 immunization. The following information was reported: EYE SWELLING (non-serious), LACRIMATION INCREASED (non-serious) all with onset 15May2022 at 05:00, outcome "recovered" (16May2022) and all described as "my left eye was swollen and watering throughout the morning". Therapeutic measures were not taken as a result of eye swelling, lacrimation increased. Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. By early afternoon it had cleared up somewhat and was back to normal the next day. Report is assessed as non-serious.
Vaginal yeast infection, thrush of the esophagus - day 8, severe diarrhea, stomach cramps - day 3.