chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received vaccine 02/04/2021. He felt very tired/fatigued from Thursday (2/4) until Sunday (2/7). Patient stated he felt much better on Monday. Then on Friday (2/12) he started having fatigue, diarrhea, headache, and rash from elbow to injection site. He went to a local Urgent Care (2/15), where he received flu and COVID testing (both negative) and steroids. He reported this information to me via phone in the vaccination clinic today (2/16).
reported delayed reaction occuring 7 days after vaccine. Rash all over body and in between fingers.
Allergy / allergic reaction to vaccine; Itchiness on his body; hives; swelling; chills; cold; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of NASOPHARYNGITIS (cold), PRURITUS (Itchiness on his body), URTICARIA (hives), SWELLING (swelling) and ALLERGY TO VACCINE (Allergy / allergic reaction to vaccine) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046A21A and 031B21A or 4) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Apr-2021, the patient experienced NASOPHARYNGITIS (cold) and CHILLS (chills). On 25-Apr-2021, the patient experienced PRURITUS (Itchiness on his body), URTICARIA (hives) and SWELLING (swelling). On 27-Apr-2021, the patient experienced ALLERGY TO VACCINE (Allergy / allergic reaction to vaccine). At the time of the report, NASOPHARYNGITIS (cold), URTICARIA (hives), ALLERGY TO VACCINE (Allergy / allergic reaction to vaccine) and CHILLS (chills) outcome was unknown and PRURITUS (Itchiness on his body) and SWELLING (swelling) was resolving. Not Provided          No concomitant medication reported.  Treatment for the event include loratadine, an allergy pill and an steroid pill for the swelling ( caller does not remember the names of the pills, maybe ¨efedrin or something like that¨)..   Action taken with mRNA-1273 in response to the events was not applicable.
History of present illness (8/25/21): This is a 55 year old female with known COVID-19 infection (symptom onset 08/21/21 and positive test 08/23/21) and PMHx including DMII, OSA, HTN, and obesity who presents to ED for progressively worsening shortness of air. Pt. reports initial symptoms included headache, body aches, and nausea/vomiting/diarrhea. She notes a productive cough with green sputum, and has developed left-sided rib pain with coughing. Pt. completed 2 series Pfizer covid vaccination on 03/12/2021.  Review of Systems (8/25/21): Constitutional: Positive for activity change, appetite change, chills, fatigue and fever.   Respiratory: Positive for cough, chest tightness and shortness of breath. Negative for wheezing.   Gastrointestinal: Positive for diarrhea, nausea and vomiting. Negative for abdominal distention, abdominal pain and constipation.  Musculoskeletal: Positive for myalgias. Negative for back pain, gait problem and joint swelling.   #Acute hypoxic respiratory failure 2/2 SARS CoV2 bilateral pneumonia (8/25/21) - Pt. O2 sat 91% on RA at rest. VBG 7.35/55/23/31.  - CXR showing mild basilar opacities (L>R) representing atelectasis vs early infection  - Afebrile with WBC (8), procal minimally elevated. CRP (127) LDH () d-dimer (0.43) -  08/25 ? starting Remdesivir and dexamethasone 6 mg PO daily with GI ppx   #Acute hypoxic respiratory failure 2/2 COVID-19 PNA (8/28/21) - Initially required O2 via NC - CXR showing mild basilar opacities (L>R)  - Continue remdesivir for 5 day course-- > end date 8/29 - Continue dexamethasone for 10 day course-- > end date 9/3 - Trend CRP and CMP while on remdesivir - Mucinex, dextromethorphan, albuterol MDI PRN - Supplemental O2 for sats >92%  Discharged home 8/29/21
2" redness and swelling around 3" top injection site right arm. Ice to area, Tylenol po q4-6. 4/24/07 at 0830
pt recv vax 5SEP96 & 2 days later pt devel intense pain in lt scapula, radiating down lt arm to elbow 4th & 5th digits of lt hand were numb & weak;
I have a pain at the back left side maybe at the back of hip; I have a pain at the back left side maybe at the back of hip; My left calf is prepared to be numb;  it would go away and come back.; This is a spontaneous report from a contactable consumer (patient). A 35-year-old female patient received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number: EW0173, expiration date: Aug2021, age at vaccination: 35-year-old), via an unspecified route of administration, administered in arm left on 27Apr2021 as DOSE 2, SINGLE for COVID-19 immunisation. No medical history was reported. Concomitant medications included ascorbic acid, betacarotene, calcium sulfate, colecalciferol, cyanocobalamin, ferrous fumarate, folic acid, nicotinamide, pyridoxine hydrochloride, retinol acetate, riboflavin, thiamine mononitrate, tocopheryl acetate, zinc oxide (PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE, CALCIUM SULFATE, COLECALCIFEROL, CYANOCOBALAMIN, FERROUS FUMARATE, FOLIC ACID, NICOTINAMIDE, PYRIDOXINE HYDROCHLORIDE, RETINOL ACETATE, RIBOFLAVIN, THIAMINE MONONITRATE, TOCOPHERYL ACETATE, ZINC OXIDE]) taken for an unspecified indication, start and stop date were not reported, cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) taken for allergic, start and stop date were not reported. Previously the patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: ER8737, age at vaccination: 35-year-old), in arm left on 06Apr2021 for COVID-19 immunization. No investigation assessment. The patient reported that she was calling and was not sure if it was related to the vaccine. She got the vaccine on Tuesday that was 27Apr2021 and then two days after Thursday (29Apr2021) she started having like her left calf was prepared to be numb, it would go away and come back. It started happening Thursday afternoon and then Friday too and then it went away but since yesterday (02May2021) afternoon she have like a pain at the back left side maybe at the back of her hip. There was no numbness right now but pain on the left side I think back of my hip. No treatment was received for the events. She was not like that and was not sure if those related or just going to the answer related to the vaccine. So, she was calling hopefully to find some answers. Consumer was informed about Pfizer Medical Information Department. The outcome of event my left calf was prepared to be numb, it would go away and come back was recovered on an unknown date in 2021 and outcome of other events was not recovered.  No follow-up attempts are needed. No further information was expected.
Initial information received on 11-Mar-2019 regarding an unsolicited non-valid non-serious case received from a consumer/non-hcp. This case involves a patient who reported exposure via skin contact on 07-Mar-2019 when the needle was withdrawn and all the medication came spewing out of the vial and onto the HCP's skin, while reconstitution of the ActHIB vial with the Diluent form vaccine PENTACEL (lot C5409AA, expiry date 10-Oct-2019) and it was difficult to do with air bubble not coming out and the whole dose was depleted. Stopper was still in tact but the vaccine came out through the stopper. Diluent Lot C5551A, expiry date 10-Oct-2019, ActHIB Vial Lot C5409AA, expiry date 10-Oct-2019. This was a case of syringe issue and exposure via skin contact. No other information was reported.
Woke up 3.5 days after injection with pain inside shoulder and inability to raise arm much more than 45 degrees.  It continues to persist although feels slightly better but still not easily able to raise my left arm completely.  Hoping this is temporary, but it is still present.
I have felt unwell since I woke up on Saturday morning. Saturday - low fever, dizzy, general malaise Sunday - low fever, general malaise, stayed in bed Monday - low fever, gastrointestinal distress, very very tired Tuesday - very very tired
This is a spontaneous report from a contactable consumer, the patient. A 39-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 06Jul2021 (at the age of 39-year-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included rosuvastatin (MANUFACTURER UNKNOWN) for unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date in 2021 as a single dose for COVID-19 immunisation. On 06Jul2021, the patient experienced headache every day since 2nd shot. The patient had headache over 30 days. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event headache every day since 2nd shot was not resolved at the time of report. The lot number for BNT162b2 was not provided and will be requested during follow up.
pt recvd vax 3JUL95 & 5JUL95 pt taken to ER for lethargy & resp irregularities;pt was transferred to another hosp;further details are unk;pt underwent extensive work/up;all test nl;dx immun rxn to pertussis;
This spontaneous report as received from a medical assistant concerning a male patient of unknown age. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. The reporter stated that another medical assistant was given order for flu vaccine and the patient was vaccinated with ZOSTAVAX, 0.65 ml, once (lot# and expiry date were not reported) intramuscularly for prophylaxis (wrong vaccine administered) (incorrect route of drug administration). No adverse events were noted by the patient. There were no product quality complaints (PQC) involved.    Additional information has been requested.
broke out in a red raised rash on trunk & face the day p/Hep B given; Md states it was a rxn to Hep B
chills; loss of taste; soreness to arm (left arm injection site); A spontaneous report was received from a  female consumer patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced soreness of arm injection site on the 1st and 2nd day, chills and loss of taste.  The patient's medical history was not provided. No concomitant medications were reported.  On 04 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 011L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On the same day, the patient experienced soreness at the injection site.   On 07 Jan 2021, the patient developed chills and loss of taste. The patient reported that she took her temperature, but it was within normal range. No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.  The event, soreness to arm injection site on the 1st and 2nd day was resolved on 05 Jan 2021. The outcome for the events, chills and loss of taste was unknown.; Reporter'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.
Child had an episode of dizziness following a dose of flu nasal spray at 11:28AM 10/28/10. 5 minutes after flu spray he c/o headache. VS taken every 5 min. Remained stable. Mo picked him up from school at 11:45.
Patient was given vaccine on 8/6/2019 around 220pm. came in on 8/8/2019 around 1020am saying that night had unbearable pain. Asked if had taken any ibuprofen for pain, patient states no amount would help. states can not move arm and has no range of motion. States no pain on injection but now feels as if the injection has gone into joint- confirmed location gave to patient as was in right upper deltiod muscular area. . Patient has placed call into his PCP to be seen.
dehydration, diarrhea, vomiting day of vax; hospitalized that evening; abn blood chem;
Around the 7th of Oct, I had a lump on my right side and on the left was a smaller lump- this got my attention so I called the Doctor. And was seen by the doctor and she ran some tests on my thyroid that came out abnormal and they did some Sonograms (days later) and then they ran the tests again and they still came out abnormal. When I went to the Doctor the first time they asked me if I wanted vaccination for shingles so I go it on that visit. Doctor referred me to Dr. (Privacy)(Endocrinologist referred to) after the second set of tests she ran. I had a video appt with the doctor yesterday and she is waiting for 1 more test result in order to determine how to treat me from there. The symptoms I experienced were heart palpitations, severe sweating, anxiety, flu like symptoms, coldness, shortness of breath and the lumps in my neck.
developed widespread hives from head to toe; patient received Engerix B 1st dose many years ago and received the 2nd dose on 30-Aug-2023; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of hives in a 36-year-old male patient who received HBV (Engerix B) (batch number 7B2YL, expiry date 25-FEB-2024) for prophylaxis.   Previously administered products included Engerix B (1st dose received many years ago on an unknown date).   On 30-AUG-2023, the patient received the 2nd dose of Engerix B. On 30-AUG-2023, an unknown time after receiving Engerix B, the patient experienced drug dose administration interval too long (Verbatim: patient received Engerix B 1st dose many years ago and received the 2nd dose on 30-Aug-2023). On an unknown date, the patient experienced hives (Verbatim: developed widespread hives from head to toe). The patient was treated with antihistamine. The outcome of the hives was resolved and the outcome of the drug dose administration interval too long was unknown.   It was unknown if the reporter considered the hives to be related to Engerix B.     It was unknown if the company considered the hives to be related to Engerix B.   Additional Information: GSK Receipt Date: 25-OCT-2023 The pharmacist reported that, a patient received the 2nd dose of Engerix B late, which led to lengthening of the vaccination scheduled. After the 2nd dose, the patient developed widespread hives from head to toe in 2023. The patient took an antihistamine and the hives subsided almost immediately in 2023. The reporter consented to follow-up via email.
2 weeks after vaccination I had severe muscle weakness in my legs and paresthesia. It was hard to walk and rise up. It seemed like gbs´; This spontaneous case was reported by a consumer and describes the occurrence of GUILLAIN-BARRE SYNDROME (2 weeks after vaccination I had severe muscle weakness in my legs and paresthesia. It was hard to walk and rise up. It seemed like gbs´) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Asthma.  Concurrent medical conditions included Asthma.    On 17-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 1 dosage form. On 01-Jun-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced GUILLAIN-BARRE SYNDROME (2 weeks after vaccination I had severe muscle weakness in my legs and paresthesia. It was hard to walk and rise up. It seemed like gbs´) (seriousness criterion medically significant). At the time of the report, GUILLAIN-BARRE SYNDROME (2 weeks after vaccination I had severe muscle weakness in my legs and paresthesia. It was hard to walk and rise up. It seemed like gbs´) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) was unknown.       Concomitant and treatment medications were not reported.  2 weeks after vaccination patient had severe muscle weakness in legs and paresthesia. It was hard to walk and rise up. It seemed like Guillain Barre syndrome. However, everyone at that time refused to believe that the vaccine could cause such adverse effects. The patient was angry for being gas lighted and imagining things.  Company comment- This is a spontaneous case concerning a 61-year-old, male patient with no relevant medical history reported, who experienced the unexpected serious (medically significant) AESI Guillain-Barre syndrome 15 days after a dose of mRNA-1273 vaccine, was administered.  It was reported patient experienced 2 weeks after vaccination severe muscle weakness in his legs and paresthesia. It was hard to walk and rise. It seemed like Guillain-Barre syndrome. However, everyone at that time refused to believe that the vaccine could cause such adverse effects.  No further details were provided for medical review. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-748336 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-748336:Invalid case
Pt. complained of severe aching in left leg six hours after receiving Hepatitis b vaccine. Pain continued through the day and began to improve the next day. Pt. stated that as a child (4 or 5 yrs. old), he had polio which severely affected his left leg.
I started getting symptoms of stuffy head, cough, sore throat, elevated temperature for 2 days, muscle aches. These symptoms have tampered off since then. I am still feeling some symptoms. I got a positive COVID-19 test on 4/23/2022 and a test at my doctor's office on 4/26/2022. I was prescribed Paxlovid and my pharmacist recommended that I do not take it due to my symptoms not being as severe.
three shots from Moderna and 4th booster was Pfizer; stroke; had whole bunch of long Covid issues come back; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Lot number: GJ3275) for covid-19 immunisation. The patient's relevant medical history included: "long covid " (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Moderna (Dose 1, single), for COVID-19 Immunization; Moderna (Dose 2, single), for COVID-19 Immunization; Moderna (Dose 3, single), for COVID-19 Immunization; Flu shot, for immunization. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "three shots from Moderna and 4th booster was Pfizer"; CEREBROVASCULAR ACCIDENT (medically significant), 21 days after the suspect product(s) administration, outcome "unknown", described as "stroke"; SUSPECTED COVID-19 (non-serious), outcome "unknown", described as "had whole bunch of long Covid issues come back". The events "stroke" and "had whole bunch of long covid issues come back" required emergency room visit. The patient underwent the following laboratory tests and procedures: stomach test: Unknown results.  Clinical course: 21 days after the patient had the Pfizer Booster, the 4th booster, the patient had the stroke. A day after he had the vaccine he was in the emergency room, and had whole bunch of long Covid issues come back immediately when he had the Pfizer vaccine. The patient never had the Pfizer product before Moderna was only fine the booster he had. They all last to week emergency room said the patient must have the adverse reaction to vaccine and it stop after that and eventually the Pfizer anticipated.
Patient received vaccination that had been left out at room temp for roughly 2 weeks on accident, rather than a dose from our new appropriately stored vial.
swollen area at the base of my neck and top of my shoulder, swollen area under her armpit; swelling and pain moved under my armpit; injection hurt a lot and stung, sore in the area; After receiving the injection she had a lump; After receiving the injection it was swollen; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (injection hurt a lot and stung, sore in the area), VACCINATION SITE MASS (After receiving the injection she had a lump), VACCINATION SITE SWELLING (After receiving the injection it was swollen), AXILLARY PAIN (swelling and pain moved under my armpit) and SWELLING (swollen area at the base of my neck and top of my shoulder, swollen area under her armpit) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033C21A and 023721A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Jun-2021, the patient experienced VACCINATION SITE PAIN (injection hurt a lot and stung, sore in the area), VACCINATION SITE MASS (After receiving the injection she had a lump) and VACCINATION SITE SWELLING (After receiving the injection it was swollen). On 05-Jun-2021, the patient experienced AXILLARY PAIN (swelling and pain moved under my armpit). On 07-Jun-2021, the patient experienced SWELLING (swollen area at the base of my neck and top of my shoulder, swollen area under her armpit). The patient was treated with IBUPROFEN for Pain, at a dose of 1 dosage form. At the time of the report, VACCINATION SITE PAIN (injection hurt a lot and stung, sore in the area), VACCINATION SITE MASS (After receiving the injection she had a lump), VACCINATION SITE SWELLING (After receiving the injection it was swollen), AXILLARY PAIN (swelling and pain moved under my armpit) and SWELLING (swollen area at the base of my neck and top of my shoulder, swollen area under her armpit) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.
Vaccine was administered to patient. Injection stie rxn of increased bleeding with minor discoloration.