chrisvoncsefalvay/vaers-outcomes huggingface dataset:
side effects; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (side effects) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On 05-Feb-2021, the patient experienced ADVERSE EVENT (side effects). At the time of the report, ADVERSE EVENT (side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided. Concomitant medication was not provided.
Mom states shook all over, stiffened, eyes rolled back & inc salivation; activity lasted about 5 mins, t104.3 @ ER 24 hrs p/vax (poss febrile seizure);
A spontaneous non-serious report of facial numbness has been received from a nurse concerning a 40-year-old female. No relevant medical or drug history information has been reported for this patient. The patient received the initial dose of FLUMIST on an unknown date. On an unknown date in October 2007, the patient reported numbness of the left side of the face 45 minutes to an hour following administration of FLUMIST into each nostril to a healthcare provider (nurse). The numbness was described as "milder than Novocaine" occurring below the patient's left eye to the margin to the lips. The numbness was without edema or any other side effects. On 15Oct2007, the reporting healthcare provider (nurse) contacted the sponsor's medical information department to discuss numbness after receiving FLUMIST. The outcome was not reported. The reporter did not provide a causality assessment for the adverse event reported. The MedImmune Product Safety Physician conservatively assessed causality for the event as possibly related to FLUMIST therapy.
High fever; body chills; sensitive skin; appetite loss; dizziness; weak muscles; sore body; emotional; drowsy; This is a spontaneous report from a non-contactable consumer (Patient). A 19-year-old female non-pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number and expiration date was not reported), via an unspecified route of administration in left arm on 20Jul2021 09:30 (at the age of 19-year-old) as dose 2, single for COVID-19 immunization. Medical history included asthma and had no allergies. Concomitant medication(s) included acetaminophen. Historical vaccine included BNT162B2 (Lot number and expiration date was not reported), via an unspecified route of administration in left arm on 01Jul2021 09:00 as dose 1, single for COVID-19 immunization. Facility type was pharmacy or drug Store. The patient did not received any other vaccine in four weeks. Patient did not tested for covid prior or post vaccination. The patient experienced high fever, body chills, sensitive skin, appetite loss, dizziness, weak muscles, sore body, emotional and drowsy on 20Jul2021 13:45. The event high fever was serious (medically significant). The patient did not received any treatment for the events. The outcome of the events was not recovered.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
administering expired flu vaccine from last year; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in an unspecified number of patients who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2020-2021 season) (batch number 47G53, expiry date 30th June 2021) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Fluarix Quadrivalent 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device. On an unknown date, unknown after receiving Fluarix Quadrivalent 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: The age at vaccination was not applicable for this report. Fluarix was given to residents age 65 above, both male and female and it was a whole facility. The patient received dose of Flu vaccine from last year that was already got expired on 30th June 2021, which led to expired vaccine used. The reporter had asked about the risks. The reporter consented to follow up via email. No specific patient demographics available as there were numerous patients involved. Health care professional also has the name of the nursing home and director. The reporter consented to follow up.
A report has been received from a health professional concerning an 11 year old, male patient with height: 56.5 inches and weight: 84.0 pounds. The patient's concurrent diseases included asthma, heart murmur, ADHD, anxiety and depression. Family history included anxiety, diabetes mellitus type 2, hypercholesterolemia and allergic rhinitis. Concomitant medications included azithromycin for infection, fluticasone propionate, salbutamol sulfate and sertraline.  The patient has been receiving nasal FLUMIST (intranasal), started on 29-Oct-2014. On 29-Oct-2014, the asthmatic patient received FLUMIST. On 11-Nov-2014, The patient was seen for fever cough, nasal congestion and sinus pain since one week and was diagnosed with acute bronchitis. On same day during physical examination was performed with findings of Mouth and throat Exam: Oral cavity/Oropharynx; hypersecretion. Chest and lung Exam: Expiratory wheeze-Both lung fields, Lymphatic Exam: Generalized lymphadenopathy. FLUMIST was continued. At the time of reporting, the event of acute bronchitis was ongoing and the outcome of the event of asthmatic patient received FLUMIST was unknown. At the time of reporting, the event of acute bronchitis was ongoing and the outcome of the event of asthmatic patient received FLUMIST was unknown. The report was considered to be non-serious by reporter.
-Large 3 inch diameter welt that was painful and itchy and lasted 2 weeks after injection  -Severe vertigo began 18 days after injection. The severe vertigo lasted 36 hours and took 13 days to completely resolve.
Consumer stated that she tested positive for covid last Saturday; Consumer stated that she tested positive for covid last Saturday; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 62-year-old female patient received BNT162b2 (BNT162B2), 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Consumer stated that she tested positive for covid last Saturday". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. The patient enquired if it will be okay for her to already receive the second booster dose as she was test Covid positive  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Large red blotch developed starting below the injection spot. It is hot, itches and feels like it has small bumps across it.
pt recvd vax & exp swollen glands, fatigue, nausea, & ear pain for up to 2 wks following vax;
Fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) in a patient of an unknown age and 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever). At the time of the report, PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.  No treatment medications were provided.
Dizziness; Heart racing; Weakness; This is a spontaneous report from a contactable other healthcare professional (nurse). A female patient of unspecified age received BNT162B2 (Pfizer-BioNTech Covid-19 Vaccine, Solution for Injection) via an unspecified route on 10Mar2021, as 1ST DOSE, SINGLE DOSE for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 10Mar2021, within ten or fifteen minutes of taking the dose, patient experienced dizziness then She came home and her heart rate was raising and she had weakness and dizziness. She also mentioned that she was negative for antibodies. She called where she got the vaccine and they said to keep monitoring and talk to her healthcare provider. Patient wanted to know if her adverse events have been reported as a side effect or are, they sign of an allergic reaction. She also wanted to know if she should take the second dose of the vaccine. She said that she has consulted her doctor and she was advised to get the second dose of the vaccine and wanted to know if it is ok to get the vaccine 3-4 months after the first dose. The patient underwent lab test and procedure which included antibodies test negative on an un-known date. The clinical outcome of the events was unknown.  Follow-up attempts are needed; Information about batch/ lot number has been requested.
pt recv vax 24NOV97 & 24NOV97 w/in 10min of vax pt exp numbness in hands, tingling in fingers & nausea;
feeling unwell; route: subcutaneously; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: The reporter is the patient.  A 59-year-old male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) subcutaneous for covid-19 immunisation; pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: MALAISE (non-serious), outcome "recovered", described as "feeling unwell"; INCORRECT ROUTE OF PRODUCT ADMINISTRATION (non-serious), outcome "unknown", described as "route: subcutaneously".  Additional information: He also mentioned feeling unwell for a day or two after being vaccinated.  The information on the batch/lot number for BNT162b2, pneumococcal 20-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s): US-PFIZER INC-202300180962 Same reporter/ drug/ event for different patients. US-PFIZER INC-PV202300080379 Same reporter/patient, different drug/AE; US-PFIZER INC-202300180835 Same reporter/ drug different event for same patients.
she belives it caused her sister neuroblastoma; Information has been received from a nurse reporting on the sister of unknown age of a consumer. The patient's concurrent conditions, medical history or concomitant medication were unknown.  On an unknown date, the patient was vaccinated with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) for prophylaxis (dose, route of administration, lot number and expiration date were not reported).  On an unknown date, the patient experienced neuroblastoma. It was unknow if the patient was treated for the event. The consumer declined the HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) vaccine because she believed it caused her sister's neuroblastoma. The outcome of the event was not reported.  The causality assessment was not provided by the nurse.  Upon internal review, neuroblastoma was considered to be medically significant.
Within 5 minutes patient developed radiating pain down both arms and arm weakness. Within 1 hour she developed a rash that started on her head and traveled down her body. Rash was painful and then pruritic. She then developed lip tingling and itching. Within 3 hours she developed nausea and vomiting and diarrhea Within 12 hours developed headache, joint pain, muscle pain, weakness
4 hrs after injection developed swollen lips, nausea. Did not go to the ER. Went home and by 7p eyes were swollen shut and some tightening of throat. To ER given IV BENADRYL and steroids.
Pt. experienced redness, inflammation et warmth to injection site. 2 days post injection site redness was 7 cm x 7 cm.
Patient received 1mL dose instead of 0.5mL; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL OVERDOSE (Patient received 1mL dose instead of 0.5mL) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006D21A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 milliliter. On 01-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ACCIDENTAL OVERDOSE (Patient received 1mL dose instead of 0.5mL). At the time of the report, ACCIDENTAL OVERDOSE (Patient received 1mL dose instead of 0.5mL) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were provided.  Nurse manager states we had an issue during our administration this morning. Three employees received a double dose of the Moderna vaccine. They received 1 whole mL instead of 0.5mL. Caller states we reached out to the them and only able to get a hold of one of them. Still trying to contact the other two.
PT's arm at area where vax'd is red, swollen and hot to touch, child feels itching at that area, has not had any fever. Child fine otherwise (DTaP 5th dose)
Pt recvd 3 doses of Engerix-B on 22MAR90, 23APR90, & 2OCT90 & was found to be a non-responder;
loss of taste in his mouth; This spontaneous case was reported by an other health care professional and describes the occurrence of AGEUSIA (loss of taste in his mouth) in a 78-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. 205F232A) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Moderna (Dose 1; batch/lot number: AS7143C) on 07-Sep-2021 and Moderna (Dose 2; batch/lot number: 040C21A) on 22-Oct-2021; for Product used for unknown indication: Flu shot on 13-Sep-2023. Past adverse reactions to the above products included No adverse event with Flu shot, Moderna and Moderna.    On 29-Sep-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 29-Sep-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced AGEUSIA (loss of taste in his mouth). At the time of the report, AGEUSIA (loss of taste in his mouth) had not resolved.            No concomitant medications were reported. Approximately 8 hours after receiving the vaccine, the patient experienced loss of taste in his mouth. Patient has reported to HCP that it is miserable and wants to know if the taste will ever come back. Patient has received 2 doses of the Moderna COVID-19 vaccine previously and did not experience any side effects. HCP was calling on behalf of the patient if this side effect has been reported by others and if there is any information on how long the patient can expect it to last. No Allergies reported and COVID-19 diagnosis was unknown. HCP states that the given lot numbers were not sure as they were handwritten. No treatment medications were reported.  Company Comment: This is a Spontaneous case reported by a health care professional, concerning a 78-year-old male patient, with no relevant medical history, who experienced the unexpected and non-serious AESI of Ageusia, which occurred 8 hours after an unspecified dose of SPIKEVAX 2023-2024 vaccine. No information disclosed about diagnostic tests performed or treatments received. At the time of the report, the event had not resolved. The benefit-risk relationship of SPIKEVAX 2023-2024 vaccine is not affected by this report.
Patient felt dizzy and was felt like he was about to pass out. Patient did not pass out or fall, but his hands and legs did feel numb. Afterward the patient did experience breathing difficulties and he was given two doses of Epipen. We attended to the patient until an ambulance arrived, though more than 3 calls had to be made before they arrived. Patient was taken by the ambulance to Health Center, but he was alert and conversing with the ambulance crew as they took him out.
Dose #1 of Moderna Vaccine given at age 17 years 10 mos
No known adverse events. Pt received Novartis brand influenza vaccine - Novartis is recommended for children ages 4 yrs & above.
Fever, Nausea, dizziness, disoriented, chills, sweating, sore throat,
11 days after 2nd shot started having extreme loud noises in ears with dizziness. Visit doctor found no fluids and cleaned wax from ears. Symptons became even worse causing many visit to ER and 1 CAT scan and MRI that came back normal. Extreme fatigue and occular migraines has becomes an issue now..visited 4 ENTs ,found no problems and 2 eye doctors from no issues (only mild cataract)
extremely swollen lymph node in right arm pit. required a doctor visit, with medical tests ordered; This is a spontaneous report from a contactable Other-HCP. This Other-HCP reported for self that the 25-year-old female patient received second dose of bnt162b2 (BNT162B2, COVID 19, Pfizer), via Intramuscular on Jan2021 03:45 PM on Right arm at single dose for covid-19 immunisation. Medical history included known allergies: shellfish, some nuts and cats. Concomitant medications included Birth control. The patient previously took first dose of bnt162b2 (BNT162B2, COVID 19, Pfizer), via Intramuscular in Dec2020 08:30 PM on Right arm at single dose for covid-19 immunisation. Facility type vaccine was hospital. No other vaccine in four weeks. The patient experienced extremely swollen lymph node in right arm pit on 20Jan2021. Required a doctor visit, with medical tests ordered from 20Jan2021. AE resulted in: [Doctor or other healthcare professional office/clinic visit]. The outcome of the event was not recovered. Treatment received included medical tests ordered. No covid prior vaccination. No covid tested post vaccination.   Information on the lot/batch number has been requested.
BLURRED VISION; TOE CRAMPING; FACE BROKE OUT/PIMPLES; NIPPLE HYPERSENSITIVITY; JOINT PAIN; FLU LIKE SYMPTOM,FEVER,HEADACHE,CHILLS,FATIGUE; This spontaneous report received from a patient concerned a 50 year old female. 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: 1808986, and expiry: 18-AUG-2021) dose was not reported, administered on 28-JUN-2021 09:30:00 for prophylactic vaccination. No concomitant medications were reported.  On 28-JUN-2021, the subject experienced flu like symptom, fever, headache, chills, fatigue. On 28-JUN-2021, the subject experienced joint pain. On 29-JUN-2021, the subject experienced nipple hypersensitivity. Treatment medications included: paracetamol. On 30-JUN-2021, the subject experienced toe cramping. On 30-JUN-2021, the subject experienced face broke out/pimples. On 03-JUL-2021, the subject experienced blurred vision. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from face broke out/pimples, and had not recovered from joint pain, flu like symptom, fever, headache, chills, fatigue, blurred vision, toe cramping, and nipple hypersensitivity. This report was non-serious.
1 shot on 01/13/21: 12 hours later her entire body swelled up, almost doubled in size. She was recommended by a nurse over the phone to take Benadryl and the swelling resolved within 24 hrs.   2 shot on 02/03/21: Within 2 hours,  her entire body swelled up and she was rushed to medical facility and treated with IV anti-histamine and steroid. Her swelling resolved with 1.5-2 hrs  Since second dose she has been met with a downpour of health issues including:  Hypertension: Diagnosis was made in February, with her blood pressure climbing to 164/98. She was started on lisinopril-HCTZ and potassium. Ongoing.  Hypothyroidism: Diagnosed in March. She gained weight, has been experiencing fatigue. They also identified 3 nodules on the thyroid. Hypothyroidism is now controlled with thyroid armour.  Sinus infection + nodules on sinus: Diagnosed in March. She was treated with 2 rounds of antibiotics but it didn't work. She also got Zyrtec and saline, but no help there either. She presently has surgery scheduled for November 5th to remove the polyps.   Tachycardia: Diagnosed in July. She saw a cardiologist who could identify the etiology. Pulse sits at 104-120.   Iliac artery: An 80% narrowing of the iliac artery was diagnosed 3 weeks ago. Requiring a stent placement.   Nodules on liver and uterus: Diagnosed 3 weeks ago. [dismissed vasculitis]. Yet to treat.   Gut issues: omeprazole. Endoscopy pending. Tear in the abdomen [suspect hernia]
Fever of 101.2; Fever of 100.6; Pain in right arm; Arm was hot; Arm was swelling; Feeling ill; Spinal pain; Pain in long bone; Pain in joints; Aching all over; A spontaneous report was received from a consumer 61 year old, female patient who developed pyrexia, pain in extremity, injection site warmth, injection site swelling, malaise, spinal pain, pain, and arthralgia.  The patient's medical history was not provided. No concomitant medication were reported.   On 28 Dec 2020, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the right arm for prophylaxis of COVID-19 infection. While receiving she felt pain in her right arm and got hot and noticed swelling. Patient reported 12 hours later she woke up with severe pain in her arm, felt ill, had spinal pain, pain in long bones, joints and spine with aching all over and a fever of 100.6 degree fahrenheit . She contacted her HCP but he could not see her at that time. At the time she placed this call she checked her temperature and it was 101.2 degree fahrenheit. No treatment medications helped to relieve her symptoms. The treatment for the events included acetaminophen, ibuprofen, and naproxen.  Action taken with mRNA-1273 in response to the events were not reported.   The events, pyrexia, pain in extremity, injection site warmth, injection site swelling, malaise, spinal pain, pain, and arthralgia, were considered unknown.  The reporter did not provide an assessment for the events, pyrexia, pain in extremity, injection site warmth, injection site swelling, malaise, spinal pain, pain, and arthralgia.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of all events, a causal relationship cannot be excluded.
Dizziness, Arthralgia, Fever, chills, injection site soreness, Narrative: