chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Lips burn; Mucus membrane in mouth was burn; Mucus membrane in their mouth was burning, swollen and sore; Mucus membrane in mouth was burn, swollen; Bad chest pains; COVID arm; This spontaneous case was reported by a consumer and describes the occurrence of ORAL DISCOMFORT (Lips burn), ORAL DISCOMFORT (Mucus membrane in mouth was burn), ORAL PAIN (Mucus membrane in their mouth was burning, swollen and sore), MOUTH SWELLING (Mucus membrane in mouth was burn, swollen) and CHEST PAIN (Bad chest pains) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, the patient experienced ORAL DISCOMFORT (Lips burn), ORAL DISCOMFORT (Mucus membrane in mouth was burn), ORAL PAIN (Mucus membrane in their mouth was burning, swollen and sore), MOUTH SWELLING (Mucus membrane in mouth was burn, swollen), CHEST PAIN (Bad chest pains) and VACCINATION SITE RASH (COVID arm). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form. At the time of the report, ORAL DISCOMFORT (Lips burn), ORAL DISCOMFORT (Mucus membrane in mouth was burn), ORAL PAIN (Mucus membrane in their mouth was burning, swollen and sore), MOUTH SWELLING (Mucus membrane in mouth was burn, swollen), CHEST PAIN (Bad chest pains) and VACCINATION SITE RASH (COVID arm) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       On 18-Mar-2021, the patient received their first dose of Moderna Covid-19 vaccine. Seven days later the patient developed COVID arm, lips burn and bad chest pains. The patient also mentioned that the mucus membrane in their mouth was burning, swollen and sore. The patient took Benadryl to treat symptoms. The only symptom that was still going on was the chest pain.   On 08-May-2021, the patient reported that all the symptoms resolved, and the patient took the second dose and was doing good.   No Concomitant product use was reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-May-2021: TCR received. Updated the outcome of all the events. Updated the action taken as per the TCR received.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded
I fainted; I was disoriented and the room was spinning.; I was disoriented and the room was spinning.; extremely nauseated; This is a spontaneous report from a contactable consumer (patient herself). A 44-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via unknown route of administration on 24Mar2021 at single dose in left arm for COVID-19 immunization. Medical history included Cancer. No known allergies. No covid prior vaccination. Patient was not pregnant at time of vaccination. Concomitant medication in two weeks included letrozole. No other vaccine in four weeks. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 immunization. It was reported that when patient woke up in the middle of the night. Patient was disoriented and the room was spinning. patient fainted and then was extremely nauseated all on 25Mar2021 02:00 AM. No treatment for adverse events. No covid tested post vaccination. The outcome of events was recovering.  Information about lot/batch number has been requested.
After HPV and Hep A were administered patient fainted and had a brief seizure lasting approx. 30 seconds.  Patient recovered and left with mom.  HPV isn't listed under vaccines: Merck, lot # 1740U, right arm, IM.
Painful at injection site, difficulty raising arm, fever during the night of the injection, body aches, nausea, loss of appetite, lightheadedness.
40 y/o female presents with c/o localized rash to the left deltoid near the site of injection in observation 10 minutes after receiving the first dose. The rash progressed with itching to the upper/lower extremities and back. Patient denies swelling, difficulty breathing, cough. Patient received 10 mg of IM Dexamethasone to the right deltoid and was transported to  due to history of adverse reaction with Benadryl
Mildly sore 2 inches around the vaccination site; This is a spontaneous report from a contactable consumer reported for herself. A 52-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EL 3247) on 22Jan2021 11:30 AM at single dose (vaccine location=right arm) for Covid-19 immunization. Medical history was none. Concomitant medications included vitamins (unspecified) and birth control. Patient was not pregnant at the time of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced Mildly sore 2 inches around the vaccination site on 22Jan2021, no treatment received for the adverse event. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient had not been tested for COVID-19. The outcome of event was recovering.
Quadracel was given on accident to a 3 years old and not the DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (DTAP) that was ordered/ No AE; Quadracel was given on accident to a 3 years old/ No AE; Initial information received on 21-Oct-2020 regarding an unsolicited valid non-serious case received from the other health care professional (Medical assistant).  This case involves a three years old male patient who received 0.5 mL DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] (lot number: C5688AA, expiry date: 26-Nov-2021) via intramuscular route in the left thigh on 19-Oct-2020 for prophylactic vaccination instead of DIP HTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE [DTAP] that was ordered (wrong product administered and product administered to patient of inappropriate age).  The patient's medical history, medical treatments, concomitant therapy, vaccinations and family history were not provided.  Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) and HEPATITIS A VACCINE (HEPATITIS A).  It was a case of an actual medication error due to the wrong vaccine administered and inappropriate age at vaccine administration (latency: same day).  Reporter can be contacted by Sanofi: Yes. Potential product technical complaint (PTC): No. Treatment: The clinic calling the manufacturer. Product was used. First time product used: Yes. Still using product: No.  At the time of report, no adverse event was reported.  Disclaimer: 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 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.
Using the bathroom every 2 minutes; This spontaneous case was reported by a patient and describes the occurrence of MICTURITION URGENCY (Using the bathroom every 2 minutes) 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) (Intramuscular) 1 dosage form. In 2021, the patient experienced MICTURITION URGENCY (Using the bathroom every 2 minutes). At the time of the report, MICTURITION URGENCY (Using the bathroom every 2 minutes) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.  Treatment information was not provided.
1:10-1:15 - Felt dizzy, blurry vision, slight nausea when RN getting ready to release her. Encouraged her to stay longer, she agreed 1:30 - C/O vaccinated arm feels weak. looked for rash, 3-5 small(pinpoint) red dots noted by client at antecubital, wrist and finger 1:35 - throat scratchy, chest raspy per client, no visible distress, swelling or othter skin changes, no noted sounds of airway blockage. C/O slight headache. 1:50 - no resolution of above, provided 50 mg oral solution Benadryl. 1:55 - Pulse 84 BP 140/102 2:05 PaO2 - 100 % Pulse 80 BP 132/100
A direct report of mine notified me that he tested positive for covid. He also reported; A direct report of mine notified me that he tested positive for covid. He also reported; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adult male 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) all with onset 11Jun2022 at 14:15, outcome "unknown" and all described as "A direct report of mine notified me that he tested positive for covid. He also reported". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (11Jun2022) positive, notes: A direct report of mine notified me that he tested positive for covid. It was unknown if therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Starting around noon on 2/7/06 pt started with intermittent high pitch crying which then escalated into non stop inconsolable crying. Mom brought her back to clinic and this was witness by staff Pt also had a fine red rash all over. Was given Benadryl 12.5 mg PO as ordered by DR. Slowly the crying lessened.
muscle spams; itching around the injection site; I had some swelling around the injection site; redness around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (muscle spams), VACCINATION SITE PRURITUS (itching around the injection site), VACCINATION SITE SWELLING (I had some swelling around the injection site) and VACCINATION SITE ERYTHEMA (redness around the injection site) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced VACCINATION SITE PRURITUS (itching around the injection site), VACCINATION SITE SWELLING (I had some swelling around the injection site) and VACCINATION SITE ERYTHEMA (redness around the injection site). On 15-Apr-2021, the patient experienced MUSCLE SPASMS (muscle spams). On 05-Apr-2021, VACCINATION SITE PRURITUS (itching around the injection site) and VACCINATION SITE SWELLING (I had some swelling around the injection site) outcome was unknown. At the time of the report, MUSCLE SPASMS (muscle spams) and VACCINATION SITE ERYTHEMA (redness around the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       LOT: 019 "B" 211A (not sure if the "B" is a B or 13), No treatment information were provided.
Information has been received from a 58 year old male consumer with asthma, high blood pressure, and an allergy to penicillin, coconut weed and egg, who on approximately 11-OCT-2007 was vaccinated with a dose of PNEUMOVAX 23 (lot # not provided). There was no concomitant medication. One hour after the vaccination, the patient experienced pain on his arm in the injection site that it felt like someone hit him on his arm and it was sore and hot. The patient also reported that his heart beats faster then normal, his breathing was heavy and he started coughing with phlegm after receiving the vaccine. According to the patient, a day after the administration of vaccine he developed pain in the other arm which was not the injection site. Unknown medical attention was sought. According to patient the soreness and pain in the injection site was gone but his breathing was still heavy. No product quality complaint was involved. Additional information has been requested.
the muscle has really tight feeling; have muscle spasm at the injection site; arm is painful; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE TIGHTNESS (the muscle has really tight feeling), VACCINATION SITE REACTION (have muscle spasm at the injection site) and VACCINATION SITE PAIN (arm is painful) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A201A) for COVID-19 vaccination.     The patient's past medical history included Spinal cord injury.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MUSCLE TIGHTNESS (the muscle has really tight feeling), VACCINATION SITE REACTION (have muscle spasm at the injection site) and VACCINATION SITE PAIN (arm is painful). At the time of the report, MUSCLE TIGHTNESS (the muscle has really tight feeling), VACCINATION SITE REACTION (have muscle spasm at the injection site) and VACCINATION SITE PAIN (arm is painful) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment medication included ibuprofen and muscle relaxer.
Initially pain/redness/swelling in injection site (left shoulder) as expected. However on the third day the pain migrated to the muscle in my left armpit. This continued for perhaps a week, then migrated into the muscle on the back of the shoulder near the armpit. It continues to hurt now nearly a month later, and I cannot left my left arm straight out to the side without extreme pain.  Light stretching and exercise has had no effect. Resting it also has had no effect.
On 4/29/01 the child began breaking out with itchy whelps all over body, most on abdomen and chest. Mother denies switching detergents, soaps etc. States only received vaccine. Treated with over the county Benadryl.
No adverse event; Patient received first dose on 18-Feb-2021 and second dose on 01-Apr-2021; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose on 18-Feb-2021 and second dose on 01-Apr-2021) and NO ADVERSE EVENT (No adverse event) in an 88-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030A21A and 038K20A) for COVID-19 prophylaxis.     Patient had no known allergies to medications, food and other products. It was unknown if patient was diagnosed or tested positive for COVID-19. It was unknown if patient was  diagnosed acute illness at the time of vaccination and or up to one month before.  The patient's past medical history included Drug therapy (Long term) since an unknown date. Previously administered products included for Drug use for unknown indication: Aspirin (Low dose(aspirin) 81mg tablet delayed release) until 12-Jun-2014. Past adverse reactions to the above products included No adverse event with Aspirin. Concurrent medical conditions included Hypertensive heart disease (without congestive heart failure), Type 2 diabetes mellitus (without complication), Hyperlipidemia, Hypothyroidism, Diabetic neuropathy (due to type 2 diabetes mellitus), Chronic kidney disease (due to type 2 diabetes mellitus), Alzheimer's disease and Vitamin D deficiency.   On 18-Feb-2021 at 2:01 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 01-Apr-2021 at 10:53 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 01-Apr-2021 at 10:53 AM, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose on 18-Feb-2021 and second dose on 01-Apr-2021). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose on 18-Feb-2021 and second dose on 01-Apr-2021) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose on 18-Feb-2021 and second dose on 01-Apr-2021).    No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2022-645743 (Patient Link).
The reaction I have now is its swollen face and neck area, rashes all over my body all very itchy skin. Those are very manageable reactions. and happened exactly a week from the first dose of the vaccine. It has been going on for 2 days now and I will be seeing my doctor later today.
Felt Pain; SWOLLEN JOINTS; Pain abdominal; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Felt Pain), JOINT SWELLING (SWOLLEN JOINTS) and ABDOMINAL PAIN (Pain abdominal) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In February 2021, the patient experienced PAIN (Felt Pain). In 2021, the patient experienced JOINT SWELLING (SWOLLEN JOINTS) and ABDOMINAL PAIN (Pain abdominal). At the time of the report, PAIN (Felt Pain), JOINT SWELLING (SWOLLEN JOINTS) and ABDOMINAL PAIN (Pain abdominal) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medication was reported.   The reporter did not provide causality for events swollen joints, pain and abdominal pain with Humira.  The reporter assessed event as pain possibly related to Moderna COVID-19 vaccine and did not provide causality for event swollen joints and pain abdominal.  It was unknown if patient was enrolled in a COVID-19 vaccine trial.  No treatment details were reported.   This case was linked to MOD-2022-627625 (Patient Link).
Patient had several ED visits within 6 weeks of receiving COVID vaccination. He first presented to the ED on 4/8/21, was admitted on 4/9/21 for 2 days. He was admitted again on 4/20/21 for 6 days. He presented to the ED on 5/8/21 with cardiac arrest and died.
p/vax devel resp distress & visible neck swelling;pt taken to ER & tx w/epi, solu-medrol & DPH;pt hosp x 24hr;pt had not returned to work as of 10/22/99;reporter noted pt asthma was controlled 7 had been having exacerbation asthma prior vax
got Shingles; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th January 2021, the patient received the 1st dose of Shingrix. In May 2021, between 3 and 5 months after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: Age at vaccination was not reported. Pharmacist reported that the patient received 1st dose of Shingrix and experienced shingles. The HCP did not have any vaccine information at the time of the call.  No further details were reported. The HCP was interested in getting the medical information letter, so she did not consent nor declined follow-up.
Fever (101.4) Rash on Arm Low bloodpressure Nausea Severe Headache
Liver transplant; This case has been considered invalid as the event mentioned of Liver Transplant is a surgical procedure and does not classify to be adverse event of the vaccine.   This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer. A patient of unspecified age and gender received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration, on an unspecified date, as single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced liver transplant (medically significant) on an unspecified date with outcome of unknown. It was not clarified if patient was scheduled to have transplant before or after 1st dose of vaccine. The patient also received the 2nd dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech) in Jun2021 for COVID-19 immunisation.  The information on the lot/batch number has been requested.
October 24, 2018, received the flu shot (Fluvcelvax, Seqirus) as part of the employee vaccination program. November 10, 2018, right pinky developed tingling and numbness that lasted for a few hours before back to normal; November 26, 2018, peroneal nerve palsy on left leg with foot drop and loss of dorsiflexion; November 29, treated with one-week oral steroid. December 8, 2018, right hand (4th and 5th finger) developed tingling, numbness, cramp, weakness and pain. The palm of the affected fingers also developed numbness and pain. Between December 8-13, hospitalized and treated with 5-day IVIG for suspected GBS or CIDP. Jan 2, 2019, received a nerve conduction test and EMG test, showing axonal loss. The diagnosis is mononeuritis multiplex. Jan 3, 2019, left hand (4th and 5th finger) developed tingling and numbness. The palm of the affected fingers also developed numbness. The extent was less severe than the right hand. So far, all the tests (e.g. blood work, spinal fluid, MRIs, x-ray, CT, urine test) showed normal results, ruling out malignancy, hematologic, rheumatologic, and infectious reasons. The patient is otherwise healthy, non-smoker, non-drinker, without any chronic diseases, and has not been taking any medications prior. The patient is currently taking gabapentin for controlling nerve pain. The patient's symptoms have been improving, limping of left leg/foot is less noticeable, gained some dorsiflexion, gained some strength back in the leg/foot, and hands.
Localized redness from inadvertent indradermal administration of Td instead of TST.
soreness in his arm.; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness in his arm.) 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 06-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, the patient experienced PAIN IN EXTREMITY (soreness in his arm.). At the time of the report, PAIN IN EXTREMITY (soreness in his arm.) outcome was unknown. Not Provided          No treatment information was provided   Reporter did not allow further contact