chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Dose administered was diulted with 1.3ml of Normal Saline instead of recommended 1.8ml of Normal Saline. Recommended 0.3ml dose given to patient. This was discovered after administration of medication. Discussed error with Medical Director and Staff, Pharmacist. Guardian notified of medication discrepancy. Stated that the child has not had any adverse reactions. Signs and symptoms of adverse reaction reviewed with guardian and told to contact emergency room if any develop.
Taste metal; Vision is blurry; Feeling dizzy; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Feeling dizzy), DYSGEUSIA (Taste metal) and VISION BLURRED (Vision is blurry) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical history was provided by the reporter.     On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Feeling dizzy), DYSGEUSIA (Taste metal) and VISION BLURRED (Vision is blurry). At the time of the report, DIZZINESS (Feeling dizzy), DYSGEUSIA (Taste metal) and VISION BLURRED (Vision is blurry) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No information regarding treatment or concomitant medication was provided.   Reporter did not allow further contact
This spontaneous report as received from a consumer refers to a female patient of 17 years old who on 15-MAR-2013 was vaccinated with GARDASIL injection, first dose intramuscular (lot # H015863, exp date: 15-MAR-2013) (indication and application site unspecified). The reporter stated that the GARDASIL vaccine was exposed to unknown temperature for 48 hours (also reported few days) due to the vaccine left in a car unrefrigerated. No adverse effect reported. On 17-MAY-2013 the patient received the second dose of GARDASIL which was stored properly. The patient's outcome was unknown. Additional information has been requested.
Date the vial was initially stored in the refrigerator: 20Sep2022 and Date of administration of vaccine: 26Oct2022; No adverse event; given bivalent booster dose which was beyond the 30 day use by datey; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (given bivalent booster dose which was beyond the 30 day use by datey), PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator: 20Sep2022 and Date of administration of vaccine: 26Oct2022) and NO ADVERSE EVENT (No adverse event) in a 92-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 prophylaxis.     No Medical History information was reported.    On 26-Oct-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 26-Oct-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (given bivalent booster dose which was beyond the 30 day use by datey). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator: 20Sep2022 and Date of administration of vaccine: 26Oct2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (given bivalent booster dose which was beyond the 30 day use by datey), PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator: 20Sep2022 and Date of administration of vaccine: 26Oct2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (given bivalent booster dose which was beyond the 30 day use by datey) and PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator: 20Sep2022 and Date of administration of vaccine: 26Oct2022).    No concomitant information provided The vial did not undergo any temperature excursions.  The patient took previously fist dose on 16-Jan-2021,sencod dose on 13-Feb-2021 and first booster 17-Nov-2021 of unknown brand.  No treatment information provided
Dose#2 4/14 at 140am, at midnight that night fever 101, with large swollen lymph node on right underarm, breast pain. Then on 4/25 woke up with droopy left eye, then next day while at gym had twitching at lips, numbness check and eye swollen was seen at ER. Was not able to raise eyebrow on left side with left ear pain. With light sensitivity, states also complaints of chest pain at time of ER visit.
Two weeks after the vaccination 01/18/2022 began to feel unwell in the late evening. Message left that condition was urgent and the doctor office called back to have her in the next. Had her continue with over the counter medication and it did not work Sought secondary opinion, then allowed the condition to work it out. Video visit.
Given MMR #2, DTaP, IPV. 15 minutes later, body red, very itchy, difficulty swallowing. Had similar reaction in 2003 from Varicella vaccine. Saw allergist. Questioned reaction from Neomycin in Varicella. Told nurse ok to give MMR (contains Neomycin). Given Benadryl, Epi Pen and taken to ER.  Discharge Summary received stated patient experienced nausea.  As per annual follow up report: pt found to be allergic to gelatin and neomycin which are components in several childhood immunizations.
Patient was given high dose flu vaccine under the age of 65. Patient had no concerns or side effects
she had developed itching, swelling, induration and skin warm to the touch.; she had developed itching, swelling, induration and skin warm to the touch.; she had developed itching, swelling, induration and skin warm to the touch.; she had developed itching, swelling, induration and skin warm to the touch.; patient was administered a second unnecessary dose of PNEUMOVAX 23 and the patient developed side effects; This spontaneous report has been received from  a nurse referring a 67-year-old female patient.  The patient's medical history, concurrent conditions, previous drugs reactions or allergies and concomitant therapies were not reported.  On an unknown date in 2021, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) 1st dose, as prophylaxis (lot number, expiration date, and route of administration were not provided). On 05-JUL-2022, the patient was vaccinated with an unnecesary second dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) 2nd dose, lot  number U034712, expiration date: 30-JUL-2023, as prophylaxis (route of administration was not provided (extra dose administered).  On 06-JUL-2022, the patient had developed itching, swelling, induration and skin warm to the touch, it was stated that the patient was the patient was seen by the healthcare provider and was treated with ketorolac tromethamine (TORADOL). The outcome of the events pruritus, swelling, induration and skin warm were not provided.  The causality assesment between pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) and pruritus, swelling, induration and skin warm was not provided. ; Sender's Comments:  US-009507513-2207USA002506:
PATIENT'S SISTER REPORTED PATIENT PASSED AWAY 03/07/2021
red circle around injection site; swollen; hot; itchy; Cellulitis; small bluish bruise; arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of CELLULITIS (Cellulitis) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 10-Jan-2021 at 3:37 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jan-2021, the patient experienced PAIN IN EXTREMITY (arm was sore). On 11-Jan-2021, the patient experienced CONTUSION (small bluish bruise). On 21-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (red circle around injection site), VACCINATION SITE SWELLING (swollen), VACCINATION SITE WARMTH (hot), VACCINATION SITE PRURITUS (itchy) and CELLULITIS (Cellulitis) (seriousness criterion medically significant). The patient was treated with CEFALEXIN MONOHYDRATE (KEFLEX [CEFALEXIN MONOHYDRATE]) at a dose of 500 milligram four times per day; LEVOCABASTINE HYDROCHLORIDE (ZYRTEC [LEVOCABASTINE HYDROCHLORIDE]) at a dose of 1 dosage form once a day and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form. On 25-Jan-2021, VACCINATION SITE SWELLING (swollen), VACCINATION SITE WARMTH (hot), VACCINATION SITE PRURITUS (itchy) and CELLULITIS (Cellulitis) had resolved. At the time of the report, PAIN IN EXTREMITY (arm was sore), CONTUSION (small bluish bruise) and VACCINATION SITE ERYTHEMA (red circle around injection site) 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 were not provided by reporter.    Most recent FOLLOW-UP information incorporated above includes: On 25-Jun-2021: Upon internal review on 25 Jun 2021, the patient age was corrected and narrative updated accordingly.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Patient received an unnecessary dose (3rd dose) of varicella. Only one dose was recorded in CHIRP, but a second dose was listed on the patient's school immunization record. This second dose was not noticed until after the varicella vaccine was administered. The patient's parent was notified of the extra dose.
Severe nausea and vomiting; severe muscle, bone, and joint pain; severe chills and teeth chattering; fever; severe injection site pain. Severe symptoms lasted for about 8 hours. Nausea lasted about 24 hours.
little redness on her arm; This is a spontaneous report from a Regulatory Authority. from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (BNT162B2, solution for injection, Lot number was not reported) dose 2 via an unspecified route of administration on 28Feb2021 as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medication was not reported. The patient previously took first dose bnt162b2 via an unspecified route of administration on 02Feb2021 for COVID-19 immunisation. On an unspecified date the patient experienced little redness on her arm. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
7 yo male p/w mom with concern for reaction to influenza vaccine. Received influenza vaccine in left deltoid yesterday. Mom noticed some redness at site initially yesterday. Pt went swimming as per usual last night. This morning awakened with increased swelling, redness and warmth to upper arm. No pain or fever per report. No previous h/o vaccine reaction. A: Cellulitis of left upper arm; adverse reaction to influenza vaccine P: - diphenhydrAMINE (BENADRYL) 12.5 mg/5 mL liquid; Give 10 mL by mouth three times daily for 2 days then every 6-8 hours as needed.  Dispense: 118 mL; Refill: 0 - cephalexin (KEFLEX) 250 mg/5 mL suspension; Take 7.1 mLs (355 mg per dose) by mouth 2 (two) times daily for 10 days.  Dispense: 142 mL; Refill: 0 - F/u in 2 days.
I have no idea if all this is correct as I did not write dates time or whatever down.  I am not trying to deceive you or what ever but I will not take the second dose.  Many medical things happened this week and I cannot remember who what or each thing  was discussed but I WAS NOT told it was a reaction but that it could be and the 2nd could be worse.  I sat here at home coughing so hard I could not catch a breath for over two hours before calling the squad.  All tests, including chest xrays came back normal,  I am not sure it was because of the covid vaccine and I am not sure it was not.  I will not be getting the second dose and taking another chance.  If you want pacifics my medical record is there.
Observation called Dr. when patient began to complain of nasal swelling/throat swellng.  Patient moved to observation room by Dr who stated patient is having an allergic reaction.No SOB/wheezing/rash/tongue swelling/urticaria.   Per patient, symptoms started 10 minutes after getting the first dosage of Moderna COVID VACCINE, V/S 160/97, 127, 83 % , repeat POx up to 100% on R/A   SYMPTOMS WERE NASAL CONGESTION, itchy and irritated throat, feeling faint, flushing. No choking of hoarseness. Able to speak without a problem.  1105 am BENADRYL 25 MG PO GIVEN.1110 V/S 170/92, 110, 98 % RA. Patient being observed in triage room, Patient stated she never had the flu vaccine, no meds, NKA, ONLY HX, GESTATIONAL DIABETES. Pt felt better but then 30 min later felt symptoms returning.  1125 158/93, 108, 16,98 %. Epi PEN, INJECTED LT thigh. 1135, Patient stated she feels better, a little cold, anxious, jittery, blue fingers. EMS called.  1150 165/65, 105, 100 % RA,  Nasal & throat swelling improving per patient.  1220 pm EMS arrived to transport patient to the ER.  Pt stalbe with V/S 169/90, 110, 100 % Husband who also received 1st dose of Moderna and had no issues was with pt the whole time.  At hospital pt received steroids, IVFs and observed for elevated BP.  Sent home about 6 hrs later on steroid taper to f/u with PCP & Allergist  Pt called on 3/27/21 at home and was doing well without complaints.
This spontaneous report was received from a healthcare worker (also reported as VFC employee) regarding an unknown number of patients. The patients demographics were unknown. There was no pertinent medical history and drug reaction or allergies of the patients reported. On an unknown date, an unknown number of patients was vaccinated with COMVAX (dose, route, product lot and expiry date was not reported), that had been improperly stored. No adverse effects reported. There was no product quality complaint involved. This is one of the several reports from the same source. Additional information has been requested.
One month aftee second shot...still no energy; cant hardly walk; Severe muscle and joint pain; Severe muscle and joint pain; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (One month aftee second shot...still no energy), GAIT DISTURBANCE (cant hardly walk), MYALGIA (Severe muscle and joint pain) and ARTHRALGIA (Severe muscle and joint pain) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 2 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 ASTHENIA (One month aftee second shot...still no energy), GAIT DISTURBANCE (cant hardly walk), MYALGIA (Severe muscle and joint pain) and ARTHRALGIA (Severe muscle and joint pain). At the time of the report, ASTHENIA (One month aftee second shot..still no energy), GAIT DISTURBANCE (cant hardly walk), MYALGIA (Severe muscle and joint pain) and ARTHRALGIA (Severe muscle and joint pain) outcome was unknown.            Concomitant medications was not provided.  Treatment medications was not provided.
pediatric dose administered to an adult; pediatric dose administered to an adult; This case was reported by a other health professional via call center representative and described the occurrence of underdose in a 27-year-old female patient who received HBV (Engerix B pediatric) (batch number P49XZ, expiry date 7th December 2023) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Engerix B pediatric and Engerix B Pre-Filled Syringe Device. On an unknown date, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were 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 provided as follows: The pediatric dose of the Engerix-B vaccine was administered to an adult, which led to underdose and adult use of a child product. No additional information was provided by the reporter. The reporter did not consent to follow up.
rebound Covid; rebound Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (005570).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, 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 "rebound Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Covid again.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202200023743 same drug /event, different patient.;
Around 2 days after receiving Fluzone HD the patient noticed a large bruise covering the width of her arm and as long as her hand. It felt warm for a few days. On 11/1/14 it ws no longer, ot, didn't hurt, and the bruise was changing colors and going away.
At 10:00, client became pale, diaphoretic, decreased BP. Used ammonia inhalant. He remained conscious; reclined. Parent notified and gave food and fluids at 10:50 and discharged to home. Transported via parent. Per parents, client has a history of fainting with needles.
Cool compresses applied and BENADRYL given at 10:00 PM on 8-12-15. Left eye started-size of dime rash-c/o burning. Pie shaped area red and slightly swollen progressed.
Confusion, diarrhea - according to family member Actually patient was admitted to hospital for altered mental status before vaccination given. Follow-up information received from reporter states * I do not have this information. I enclosed the form below when I gave my report.
A small knot formed below the area where the vaccine was administered. BENADRYL 25 mg was administered orally to the patient and the swelling subsided with 5 minutes.
Itching that began at the site of injection that quickly spread down the arm and onto the back, Called doctor, and she told me to take Benadryl for the rest of the day, and go to the hospital if breathing became difficult.  Benadryl worked, but still itchy more than 24 hours later if not taking Benadryl. Never had trouble breathing.
Extreme Muscle pain in left leg; Can not walk; Blood work report abnormal; This is a spontaneous report from a contactable consumer. A 70-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in Arm Right on 01Apr2021 09:45 (Batch/Lot Number: EN6208) as SINGLE DOSE for covid-19 immunisation. Medical history included Stroke 7 years ago. The patient's concomitant medications were not reported. The patient received first dose of BNT162B2 on 11Mar2021 10:00 AM in right arm for COVID-19 immunization at 70-years-old (lot number: 9W6205). On 02Apr2021, the patient experienced extreme muscle pain in left leg, can not walk, and blood work report abnormal. The events were assessed as serious (disability). The patient underwent lab tests and procedures which included blood test: abnormal on an unspecified date. Blood work report abnormal. The patient received treatment for the events: Ae treatment: Dr. adjusted Potassium and Diuretic Meds. The outcome of the events was not recovered.
pt admitted to hosp with worsening SOB; HRF, positive for COVID; pneumonia; O2 supplementation; given ABX, remdesivir, dexamethasone; worsened clinically; unresponsive to sternal rub; transitioned to comfort measures; pt passed away in the hosp
pneumonia; This spontaneous report has been received from a lawyer, regarding a case in litigation and refers to a 62-year-old patient of an unknown gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. The patient was prescribed zoster vaccine live (ZOSTAVAX) vaccine by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 03-APR-2015, the patient was administered zoster vaccine live (ZOSTAVAX) (dose, anatomical location, route of administration, lot # and expiry date were not provided) at pharmacy by a pharmacist. The patient suffered the following injuries and was diagnosed on the following dates as a result of the zoster vaccine live (ZOSTAVAX) vaccine: pneumonia and was diagnosed on 09-JUN-2015. The outcome of the event was not provided. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review, the event of pneumonia was considered to be medically significant.
3 days after vaccination, patient had itching , soreness and swelling at injection site. She was treated with Zyrtec and saw doctor and was prescribed cephalexin for cellulitis.  Patient musch better now, jus a little sore.