chrisvoncsefalvay/vaers-outcomes huggingface dataset:
enlarged lymph node; nauseous; Her hands became itchy; unable to eat solid food/not able to hold down food; pain (stomach); lost 10 pounds; liver not functioning properly; A little sick/immune system was not liking it very much; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (A little sick/immune system was not liking it very much), PRURITUS (Her hands became itchy), FEEDING DISORDER (unable to eat solid food/not able to hold down food), ABDOMINAL PAIN UPPER (pain (stomach)) and WEIGHT LOSS POOR (lost 10 pounds) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 19-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In August 2021, the patient experienced ILLNESS (A little sick/immune system was not liking it very much). In September 2021, the patient experienced PRURITUS (Her hands became itchy), FEEDING DISORDER (unable to eat solid food/not able to hold down food), ABDOMINAL PAIN UPPER (pain (stomach)), WEIGHT LOSS POOR (lost 10 pounds), HEPATIC FUNCTION ABNORMAL (liver not functioning properly) and NAUSEA (nauseous). On 24-Sep-2021, the patient experienced LYMPHADENOPATHY (enlarged lymph node). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) in September 2021 for Nausea, at an unspecified dose and frequency; ONDANSETRON in September 2021 for Nausea, at an unspecified dose and frequency and DICYCLOVERINE HYDROCHLORIDE (BENTYL) in September 2021 for Nausea, at an unspecified dose and frequency. At the time of the report, ILLNESS (A little sick/immune system was not liking it very much), PRURITUS (Her hands became itchy), FEEDING DISORDER (unable to eat solid food/not able to hold down food), ABDOMINAL PAIN UPPER (pain (stomach)), WEIGHT LOSS POOR (lost 10 pounds) and NAUSEA (nauseous) outcome was unknown, HEPATIC FUNCTION ABNORMAL (liver not functioning properly) was resolving and LYMPHADENOPATHY (enlarged lymph node) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In September 2021, Alanine aminotransferase: high (High) Alanine aminotransferase was high. In September 2021, Aspartate aminotransferase: high (High) Aspartate aminotransferase was high. In September 2021, Blood phosphorus: high (High) Blood phosphorus was high. On 24-Sep-2021, Computerised tomogram: abnormal (abnormal) Computerised tomogram scan with contrast finding an enlarged lymph node in the lower right quadrant of her stomach region where her liver is located.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  The patient's enzyme levels were returning to normal and her lymph node has returned to normal size.
pt recv vax 25JAN96 & 1MAY97 pt devel 30 to 40 chickenpox;
This spontaneous report as received from a healthcare worker, practice manager refers to unknown number of patients of unknown age and gender. On an unknown date in 2014 the patients were vaccinated with PNEUMOVAX 23 (dose number, route of administration, anatomical location, lot number were not provided). The health care worker reported, the storage compartments that contained PNEUMOVAX 23 were not monitored at all from 03-MAY-2014 until the report time (10-JUN-2014). Doses of the vaccines that were exposed to unknown temperatures were administered to unspecified patients. The practice manager stated that would provide the names of the patients who received doses of the unmonitored vaccines in during the period of time from 03-MAY-2014 until the present (date of this report 10-JUN-2014). She stated that her practice has not been informed of any adverse experiences. On 17-JUN-2014 follow-up information has been received. All telephone attempts to obtain follow-up information have been unsuccessful. A request was made for patient identifiers, lot numbers, expiration dates and dates of administration. Follow up information was received on 23-JUN-2014 from registered nurse. The nurse stated that there were 10 doses of (trade name not provided) previously reported as PNEUMOVAX 23, lot # K004930, expiry date 16-MAR-2015 stored in refrigerator that were not monitored at all from 03-MAY-2014 until the report time (10-JUN-2014). This is one of several reports from the same source. Additional information is not expected.
My son recieved a DTaP and a hep B vaccine from the physician. As we were leaving the facility within five minutes following receiving the shot I stood at the receptionist desk checking out and saw my son laying on  the ground. I ran to him. His back was arched his head tilted back and both feet rising and lowering creating a banging back and forth. He was not responsive. I called for help three times yelling loudly. Staff finally came and ran from one end of the building to the other before putting him on an empty exam room table. Vitals were taken and within 2 to 4 minutes he came around. He steadily improved over the course of the next hour. The physician cleared him to leave. He complains of arm soreness and left leg weakness 24 hours following incident.
Severe muscle fatigue; This case was reported by a consumer via interactive digital media and described the occurrence of muscle fatigue in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, less than 4 months after receiving Shingles vaccine, the patient experienced muscle fatigue. On an unknown date, the outcome of the muscle fatigue was not recovered/not resolved.   It was unknown if the reporter considered the muscle fatigue to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 10-OCT-2022 Reporter's Comment: This case was reported by patient via interactive digital media. The patient received a dose of Shingles vaccine 4 months ago (the day before reporting) and still had severe muscle fatigue. The patient thought he/she would rather had the virus. Additional supportive information: The follow-up would not possible, as no contact, details were available.
Information has been received from a physician concerning a pt who on approximately 2/22/00 was vaccinated with one dose of varicella vaccine. Subsequently the pt developed a rash. Additional information has been requested.
numbness on lips and appeared flushed in the face. 174/82, 195/85, 87, 98%. Transported to assess hypertension
My right arm that was injected with the Pneumonia vaccine was increasingly getting sore throughout the first day and by the night it felt sorer than the average soreness I usually feel from vaccines. The second night, alongside the soreness, I noticed red hives at the top of the right inner part of my right arm and hives on the back of my right arm. I took Benadryl that night to see if the hives would go away. The 3rd day (today) the red hives have spread more on the inner top part of my right arm getting closer to my armpit. My right arm is still sore and the muscle feels tight. My arm also appears swollen where the muscle is tight and the hives are. My left arm with the flu vaccine has no unusual events.
dizzy spells; heart rate was real high; tingling all over my body like mini shivers inside my body; bad shivers, it was making my body tremble bad; This spontaneous case was reported by an other health care professional and describes the occurrence of DIZZINESS (dizzy spells), TACHYCARDIA (heart rate was real high), PARAESTHESIA (tingling all over my body like mini shivers inside my body) and CHILLS (bad shivers, it was making my body tremble bad) in a 27-year-old patient of an unknown gender 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (dizzy spells). an unknown date, the patient experienced TACHYCARDIA (heart rate was real high), PARAESTHESIA (tingling all over my body like mini shivers inside my body) and CHILLS (bad shivers, it was making my body tremble bad). At the time of the report, DIZZINESS (dizzy spells), TACHYCARDIA (heart rate was real high), PARAESTHESIA (tingling all over my body like mini shivers inside my body) and CHILLS (bad shivers, it was making my body tremble bad) 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 product use was not provided by the reporter. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 19-Jul-2021: Follow up received on 20-JULY-2021 does not contain any new information.
This case was reported by a consumer via call center representative and described the occurrence of burning sensation in a 62-year-old female patient who received SHINGRIX for prophylaxis. Concomitant products included SHINGRIX. On 7th January 2019, the patient received the 2nd dose of SHINGRIX. On 7th January 2019, immediately after receiving SHINGRIX, the patient experienced burning sensation. In January 2019, the patient experienced injection site rash, injection site itching, swelling arm, pain in arm and scratch. The patient was treated with dermatologicals NOS (Anti-Itch Cream (Medication Unknown)). On an unknown date, the outcome of the burning sensation was recovered/resolved and the outcome of the injection site rash, injection site itching, swelling arm, pain in arm and scratch were unknown. It was unknown if the reporter considered the burning sensation, injection site rash, injection site itching, swelling arm, pain in arm and scratch to be related to SHINGRIX. Additional details were provided as follows: On 1st November 2018, the patient received 1st dose of SHINGRIX (refer case US2019GSK016724). After receiving 2nd dose of SHINGRIX, the patient experienced burning sensation or burnt like fire while the vaccine was going into her skin for several days after that it was sore. Less than a month after receiving 2nd dose of SHINGRIX, the patient's left arm became swollen, the patient was left with an itching sensation where the vaccine was given and stated it hurts like the Dickens. The patient broke out with a rash and stated that she had sores on her arm due to the constant scratching she done to her arm from the itching. The patient had tried anti-itch cream but nothing worked. The patient declined permission to contact her doctor. The patient consented to follow up.
Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 27-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Jun-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 17-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that the patient took the vaccine on 17-Jun-2021 after 6 days from first puncture.  Concomitant medications were not reported. No treatment information was provided.
family members having covid right now; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (family members having covid right now) 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. In November 2021, the patient experienced COVID-19 (family members having covid right now). At the time of the report, COVID-19 (family members having covid right now) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter stated that the patients having COVID-19 on 7,8,9,10 of November 2021. No relevant concomitant medications were reported. Treatment medication was not provided by the reporter.  This is a Spontaneous case concerning a female patient of unknown age with unknown medical history,  who experienced the unexpected  non serious (AESI) event of COVD 19. The event occurred after a dose of a COVID 19 vaccine that wasn´t confirm to be mRNA 1273 vaccine. Unknown time to onset or dosage number.  The rechallenge is not applicable. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.   This case was linked to MOD-2021-164247, MOD-2021-164267 (Patient Link). Sender's Comments: This is a Spontaneous case concerning a female patient of unknown age with unknown medical history,  who experienced the unexpected  non serious (AESI) event of COVD 19. The event occurred after a dose of a COVID 19 vaccine that wasn´t confirm to be mRNA 1273 vaccine. Unknown time to onset or dosage number.  The rechallenge is not applicable. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.
Information has been received from a registered nurse concerning a 7 year old male who on 04/02/99 was vaccinated with a dose of Varivax SC in the left arm. There was no concomitant medication. On 04/20/01, the patient had breakthrough varicella with a rash on the trunk, face and legs. There was no prescription drug treatment required for the experience. It reported that the patient recovered one week later. Additional information has been requested.
Patient reported feeling sweaty, mildly nauseous, tingly in his hands and teeth/roof of mouth, flushing of the face and ears. Treatment included administering an ice pack for the patient's neck and a cool towel for the patient's forehead. Observed patient for 30 minutes, and he made a full recovery  within 25 minutes of vaccine administration.
Systemic: Chills-Mild, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Head pain from hit his head to the shelf-Medium, Systemic: Nausea-Mild, Systemic: Shakiness-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Systemic: Weakness-Mild, Additional Details: Patient was resting in the observation area after getting his 1st shot. He fainted and hit his head on the shelf. Patient's main concern is the head pain from his head trauma. His wife will take him to the hospital for head scan. Wife will follow up with the store with his condition.
got very sick; Initial information received on 26-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer/non-hcp via social media.  This case involves a patient of unknown age who got very sick (illness), while patient was treated with Influenza Vaccine.  Medical history, past medical treatment(s) and family history were not provided.  Concomitant medication was not reported.  On an unknown date, the patient received influenza vaccine [lot number: unknown and expiration date: unknown] at an unknown dose via unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, (latency: unknown) after starting the suspect vaccine therapy, patient got very sick (illness).  No laboratory data was reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the event was unknown.  There will be no information available regarding batch number in this case.
The 6th day, post vax, pt developed fever; 7th day, post vax, rash on face and then trunk; 10th day, post vax, rash on extremities. Saw doctor on 6/15/01. No treatment except Benadryl. Rash started clearing up on 6/17/01.
3JUN97 pt came back to clinic for a recheck on corneal abrasion, & an adverse rxn;sx lt deltoid swollen & warm, chest pain, chills, jaw pain, SOB:tx DPH, Medrol dose pack, Depo Medrol;
So, I had 3 patches of a rash and they were small with no fluid inside with red color, one on my shoulder, one on my upper arm and my lower back. It felt kind of numb and weird feeling. I emailed my doctor and she prescribed me valacyclovir 1-gram 3x a day. They started healing but every single one had small black dots/scabs.
Pentacel dose that was administered had expired with no reported adverse event; Initial information received on 03-Apr-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 7 months old male patient to whom diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)] dose that was administered had expired with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included ROTAVIRUS VACCINE for Prophylactic vaccination.  On 03-Apr-2023, the patient received dose 3 at 0.5 mL dose of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine, Suspension for injection, (lot UJ644AAA; expiry date: 02-Apr-2023) via unknown route in the right vastus lateralis for immunization with no reported adverse event (expired product administered) (latency: same day).  No lab data was reported.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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.
Multiple-day migraine ongoing; 6-hour fever (100.8 deg F) on 6/7/2021; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old male patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 06Jun2021 at 16:45 (at the age of 33-year-old) as a single dose for COVID-19 immunisation. Medical history included sulfonamide allergy. Concomitant medications included metoprolol succinate (TOPROL XL) for an unknown indication from an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 07Jun2021 at 14:30 the patient experienced multiple-day migraine ongoing and 6-hour fever (100.8 deg F). The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of the events which included treatment with ibuprofen (MANUFACTURER UNKNOWN) on an unknown date. The clinical outcome of the events migraine and fever were not recovered at the time of this report.   The lot number for, BNT162b2, were not provided and will be requested during follow up.
?In this case, 0.9% NS nebulizer solution was used. I am unable to find the ingredients without having the package of what exactly they used, but the front of the Addipak box states that no bacteriostatic or preservative agents were added. In the case of NS for injection, it sometimes contains various ingredients (differing by manufacturer) for pH control and such, and this is not an issue, so while I can't say for certain without seeing the ingredients on the box, I think that the doses are acceptable and the children who received this can move on to their second dose.  To clarify-pediatric Pfizer Covid-19 Pfizer vaccine was reconstituted with NS for inhalation not with supplied NS for parenteral injection.
After the vaccine: Pain in the injection site area - mild to moderate pain. General fatigue - started the evening of the 21st. That continued for the next 24 hours or so. The evening of 22nd, I started to experience body aches, fever, and just probably more moderate fatigue. Those continued throughout the weekend. I treated with Tylenol. Monday, yesterday, the fever subsided. As well as a lot of the body aches and everything. Now I'm dealing with a bad sore throat with lesions and sores in my throat. I have been developing the classic hand, foot, mouth sores and hand and feet as well. I haven't reached to my doctor because my son had it and my wife has it as well. So I haven't sought care as there is really no treatment for it.
10/8/21: 86yr old female arrived to ED via private car with son. She has complaints of feeling weak. Started about 11:30am yesterday. She had been checking her blood pressure and heart rate at home. Heart rate in the 40's. Blood pressure 90's/60's. Denies pain. She had pressure in the back of her neck yesterday and took some Tylenol which helped. She just feels "weak" in the knees.   CBC, BMP done  Patient Stabilized and Transferred  Transferred to Hospital via EMS and then discharged on 10/9/21. Diagnosis: bradycardia, stopped carvedilol  follow up with cardiology in 4 weeks.
Initial unsolicited report received from a non healthcare professional (patient's daughter) on 04-Nov-2015. This case involves a 76 years old male patient (age reported as 77 years) who was vaccinated with a first dose of FLUZONE HD via intramuscular route (manufacturer: Sanofi Pasteur, batch number: UI437AB, expiry date: 29-Mar-2016, dose details and site of administration were not reported) on 22-Sep-2015. The patient had no illness at the time of vaccination and no known drug allergies. Patient had a history of hypertension and congestive heart failure. Birth defects were not reported. On 24-Sep-2015, two days post vaccination, the patient started with a cough, fever and general body aches which continued since then and he had lost 15 lbs by the time of reporting. On an unspecified date post vaccination, he had suffered a cracked rib from coughing. Multiple outpatient doctors had seen him without a diagnosis. On the day of reporting, the patient began hallucinating and his wife took him to the cardiologist who referred him to other clinic. His daughter expressed her concern that her dad was dying and would not make it through the night let alone visiting the clinic. The daughter stated that she would be taking him to the emergency room for evaluation (the patient requiring Emergency Room/Doctor Visit). Laboratory investigations included chest x-ray, CAT (Computerized Axial Tomography) scan of chest, results were not provided. Corrective treatment was not reported. The patient had not recovered from the above mentioned events. Upon internal review this case was considered serious due to important medical event: suffered a cracked rib from coughing. List of documents held by sender: none.
This spontaneous case, initially received from a physician on 22-Oct-2018, concerns a 02-year-old, child female patient. The patient had no relevant medical history. The patient was not taking any medication at the time of vaccination. On 06-Oct-2018, the patient (under age of 4 years) was administered FLUCELVAX QIVc (route of administration: intramuscular, anatomical location: left thigh, batch number: 252664, dose and expiry date: not reported). No treatment measure was taken. At the time of this report, no adverse event was reported after the vaccine administration. The reporter assessed this case as non-serious.