chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Extreme fatigue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of FATIGUE (Extreme fatigue) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced FATIGUE (Extreme fatigue). On 03-Mar-2021, FATIGUE (Extreme fatigue) had resolved. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant medications not reported. No treatment information provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-067195 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-067195:Cross linked with dose 2
PT STATES THAT SHE STARTED ITCHING AROUND 05:15 AM. THEN AROUND 5:15 PM SHE CAME UP WITH HIVES. PT STATES THAT SHE TOOK BENADRYL AND TOOK A WARM BATH, THEN HIVES DISAPPEARED. PT STATES THAT THE ITCHING HAS ALMOST COMPLETELY STOPPED.
This spontaneous report was received from a phlebotomist regarding a patient of unknown demographics. There was no information about concurrent condition and historical medication. On 30-AUG-2016 the patient was inadvertently vaccinated with PNEUMOVAX 23, intramuscular injection, in the left arm, lot # L003188/expiration date - 06-JUL-2016. No adverse event was reported. No concomitant medication was reported. The outcome of the event was unknown. No PQC (product quality complaint) was involved. Additional information has been requested.
administered an expired dose (30Jun2022) today (01Jul2022); This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 12-year-old male patient who received Men B NVS (Bexsero) (batch number ABXb27aa, expiry date 30th June 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 1st August 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 1st August 2022, unknown after receiving Bexsero and Bexsero 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 Information: GSK receipt date: 01-Aug-2022 Reporter's comment: The nurse reported that a patient was inadvertently administered an expired dose of Bexsero on the day of reporting. The reporter declined follow-up from Safety. Additional supportive information: The patient received an expired dose of Bexsero, which led to expired vaccine used.
received the recall batch of Shingrix that GSK issued on 02/10/2021; received the recall batch of Shingrix that GSK issued on 02/10/2021; This case was reported by a other health professional via call center representative and described the occurrence of recalled drug administered in a 59-year-old female patient who received Herpes zoster (Shingrix) (batch number TT2JF, expiry date 28th October 2022) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced recalled drug administered and drug dispensing error. On an unknown date, the outcome of the recalled drug administered and drug dispensing error were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, the patient received the recall batch of Shingrix that Glaxosmithkline issued on 10th February 2021. The reporter stated that, the lot number was not 9LH3Y and was not sure if this the lot number from one of the vials. The reporter stated that, the vaccine was administered to the patient before the recall of drug. This case was 1 of 8 linked cases, reported by same reporter for different patients. The reporter consented to follow up via email.
Presented with SOB/ productive cough; dx Covid; husband Covid +; treated with Remdesivir, breathing tx; steroids, Vit C, zinc, antibiotics, discharged home with home O2
her lipids were elevated; shoulder pain; bicep pain; headache; It was an entire abdominal spasm and in the back too; It was an entire abdominal spasm and in the back too; she felt a twisting in her  entire abdomen, lasted 25 minutes, it was awfully painful, but went away; This is a spontaneous report from a contactable consumer. This 68-years-old female reported for herself that: A 68-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 23Feb2021 (at the age of 68-year-old) as single dose for covid-19 immunisation. Patient was not pregnant at the time of vaccination. The patient medical history and concomitant medications were not reported. The patient's historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation and experienced chills, headache, and nausea. Patient stated she received the second dose of the Covid 19 vaccine on 23Feb2021. After the first dose she experienced chills, headache, and nausea; but on 24Feb2021, she felt a twisting in her entire abdomen, lasted 25 minutes, it was awfully painful, but went away. She went to the ER, her lipids were elevated, they told her that it may be a side effect of the vaccine. She also had shoulder pain, bicep pain and headache. Yesterday (March 1st) she experienced the same abdominal pain, lasted 15 to 20 minutes, and then subsided, she went to the ER again and they couldn't find anything abnormal. She had a follow up appointment with her doctor today (March 2nd), it happened again and lasted 15 minutes then subsided. It was an entire abdominal spasm and, in the back, too. She is not sure anymore if it is related to the vaccine. The event resulted to visit emergency room. The patient underwent lab tests and procedures which included lipids: increase on an unspecified date lipid were elevated. The outcome of the event she felt a twisting in her entire abdomen, lasted 25 minutes, it was awfully painful, but went away was recovered and all other events were unknown.   No follow up attempts are possible. Information about Lot/batch number cannot be obtained.
After Tdap administration few mins patient became dizzy and immediately fainted. I assisted her to the floor. She became verbally responsive after about 1 min. She was following commands. Elevated legs and placed cold compress to head. Rested on floor about 10 mins. then placed on exam table with fan and ice pack drinking water. For about 20 mins room was very hot.
Patient states that one week later - she is experiencing heavy urinary bleeding - fresh, red blood - no pain or irritation.
Dose administered after 12 hours of vial puncture; Dose administered after being more than 24 hours at room temperature; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 12 hours of vial puncture) and PRODUCT TEMPERATURE EXCURSION ISSUE (Dose administered after being more than 24 hours at room temperature) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Oct-2021 at 12:27 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Oct-2021 at 12:27 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 12 hours of vial puncture) and PRODUCT TEMPERATURE EXCURSION ISSUE (Dose administered after being more than 24 hours at room temperature). On 13-Oct-2021 at 12:27 PM, EXPIRED PRODUCT ADMINISTERED (Dose administered after 12 hours of vial puncture) and PRODUCT TEMPERATURE EXCURSION ISSUE (Dose administered after being more than 24 hours at room temperature) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. This case is a report of the adverse events of patient 3. The vial was reported to be in the freezer prior to 11-Oct-2021. On 11-Oct-2021, the vial was stored in the refrigerator. On 12-Oct-2021 at 8:00 AM around 30 hours, they were taken out of the fridge to the room temperature. On 12-Oct-2021 at 10:00 AM, the vial was punctured. After puncture, the vial was stored at room temperature. Total amount of time the vial was exposed to temperature range (8 to 25 degree Celsius ( 46 to 77 degree Fahrenheit).   This case was linked to MOD-2021-351075, MOD-2021-351200  , MOD-2021-352001  , MOD-2021-352549 (Patient Link).
Pain and burning to back of neck and scalp began on 5.11.2021.  Visit to urgent care on 5.14.2021 and prescribed medication for muscle pain (flexeril and motrin) and antibiotic (augmentin) due to enlarged lymph node behind ear and clavicle area. Rash developed to the left side of neck on the evening of 5.15.2021. Returned to Urgent Care on 5.16.2021 and started on Valtrex for shingles. Shingles rash worsened over the following days spreading up on left side of scalp, left side of neck, and down to left shoulder, left side of chest. Rash began to receed on 5.20.2021. On date of report 5.56.2021 slight rash remains to base/back of neck and onto scalp. Pain and burning remain, worsened by pressure/touch and heat.
"A parent reported that her 6 week daughter received the first dose of Rota Shield, DTaP (Wyeth lederle), Hib (Wyeth-Lederle) and IPV (Aventis Pasteur SA) vaccines on 06/18/99. Approximately two weeks post-immunization. the infant developed abdominal pain and irritability, which lasted two weeks. Mucus was seen in the stool for the first two days. As of 07/23/99, the infant continued to awake nightly with abdominal pain." From follow-up correspondence received at Aventis Pasteur Inc. on 02/15/00, it was reported that the patient recovered from this experience. From mailed follow-up #2 correspondence received on 06/17/01, "Patient has recovered, phone follow-up on 05/25/01, probably this adverse event was related to Rota Shield vaccine given same day. This case is closed.
Pt is known asthmatic; pt devel sneezing, stuffy nose, hives, itchy eyes & wheezing immediately p/given MMR & PPD; tx DPH & Epi;
This case was reported by a healthcare professional (also the subject) and described the occurrence of injection site pain in a 45-year-old female subject who was vaccinated with HAVRIX (GlaxoSmithKline). The subject had not experienced adverse events following previous vaccinations. Concurrent medications included TRIAMTERENE, MAXIDE and MULTIVITAMINS. On 12 May 2009 the subject received 1st dose of HAVRIX (unknown route, right arm). On 12 May 2009, immediately after vaccination with HAVRIX, the subject experienced injection site pain. On 22 May 2009, the pain had spread from her right shoulder/scapula down her arm and in her hand. On 28 May 2009, 16 days after vaccination with HAVRIX, the subject experienced neck pain and numbness in her right hand. The subject intended to seek medical attention. The healthcare professional considered the events were disabling. The subject was treated with MOTRIN. At the time of reporting the events had worsened. The healthcare professional considered the events were probably related to vaccination with HAVRIX.
Was detained one hr. to monitor adverse signs, later could not walk. Went to work and 2 1/2 hrs later I suddenly felt strange/weird sights and disorientation - profuse sweating and co-workers said I was literally bouncing off walls. Drove later to emergency room. Triage nurse thought I was drunk/drinking.
Started having bad flank pain the morning after her vaccination. She ended up going to hospital where a CT was done. Diagnosed with gastritis.
Patient experienced extreme pain in right pointer finger on 10/21/19 diagnosed as herpatic whitlow.
Swelling and redness in the face, tingling and pricking sensation (feeling like pins)
pt recvd vax 5MAR93 Pm & was given APAP prior to vax; 7PM started crying & screaming high pitch; cont high pitch scream until 12MN; mom called MD 845PM; t104 w/high pitch scream & crying;
COVID; COVID; This is a spontaneous report received from a non-contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 47-year-old female patient (not pregnant) received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 47 years, in left arm for covid-19 immunisation. The patient had no relevant medical history and had no known allergies. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete;  unknown manufacturer), for COVID-19 immunisation. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "not recovered" and all described as "COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Result. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
On 08/31/2000 the patient developed varicella with greater than 50 lesions. Subsequently, the patient recovered. Two additional patients had a similar experience following exposure to varicella virus vaccine live. No further information is available.
The patient is a 67 y male who was admitted for chest pain, elevated troponin possible demand ischemia, recent covid 19 infection, body aches, sepsisi possible due to acute cystitis +pseudomonas, recent cystoscopy didn't take abx prescribed by urology. Treated with respiratory protocol, abx, cpap.
The pt experienced facial flushing and sweating. Severe cough and dizziness. Tachycardia and shortness of breath were also experienced.
Scratchy throat, runny nose, some sneezing, and some fever. Not debilitating but irritating.
Large swelling and redness. Pain and hot to the touch. Took ibuprofen. Lasted about 3 days. Pain and swelling went away and now just itchiness at the sight with no redness.
I have had cramping in my legs, feet, and abdomen and diarrhea with urgency about 4-5 times a day.
SORE ARM; This case was reported by a consumer via and described the occurrence of pain in arm in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 6 months after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received Shingrix and had sore arm.  The patient got both doses 6 months apart and got it late in 2019. The patient also got the Pfizer 3 weeks apart. For tolerances of 2nd dose, refer case US2021AMR025854, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR025854:same reporter
Swelling of the paridio gland and surounding glands around the right jaw line to the back of his ear and neck. Fever of 101-102 rash on other cheek. Tiredness for so far 5 days after the doc visit. Very little vomit.
rash around injection site - left arm; headache; chills; real tired; itchy around injection site - left arm; red around injection site - left arm; welts around injection site - left arm; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash around injection site - left arm), HEADACHE (headache), CHILLS (chills), FATIGUE (real tired) and PRURITUS (itchy around injection site - left arm) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH (rash around injection site - left arm), HEADACHE (headache), CHILLS (chills), FATIGUE (real tired), PRURITUS (itchy around injection site - left arm), ERYTHEMA (red around injection site - left arm) and URTICARIA (welts around injection site - left arm). At the time of the report, RASH (rash around injection site - left arm), HEADACHE (headache), CHILLS (chills), FATIGUE (real tired), PRURITUS (itchy around injection site - left arm), ERYTHEMA (red around injection site - left arm) and URTICARIA (welts around injection site - left arm) 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.   No Concomitant medication were reported. Treatment medication was not provided.
Patient was vaccinated at approximately 0900. At 1500 she notified onsite staff of pain and decreased range of motion with her left upper extremity. LUE was swollen. Reported "tingling" sensation in fingers. She was provided an ice pack and was referred to urgent care for follow up. Patient went to an urgent care facility which referred her to a hospital. Hospital recommended alternating heat/cold to the site and prescribed muscle relaxant. On 12/12 I spoke with the patient by phone. She reported that the pain gradually decreased in the days following the vaccination but pain is still present and range of motion is still limited due to pain. She remarked that the site remains tender especially when heat/cold is applied.
Miscarriage: LMP  11/17/20, diagnosis of MAB on 1/26/21. Chromosomal testing of the embryo determined cause of miscarriage to be trisomy 12.  Prior to this most recent miscarriage I had 3 previous miscarriages and 1 live birth (1 living child).  To be clear, I do not blame the vaccine for the miscarriage, the chromosomes of the embryo were determined before I got my first Covid vaccine.
Patient returned to Immunization department 11:15 hives on face, chest, back, R/L arms-skin red/erythema.Patient reports mouth is tingely. Lip swelling. 11:30 am patient received 50mg IM of Diphenhydramine. 0.3mg of epinephrine administered @11:43 am. Patient reported she felt lightheaded along with above symptoms after receiving epi-pen. Transported by EMS to Hospital.
Pain & tingling in all extremities; difficulty walking sx aggravated by exercise; areas involved were both feet along sides & soles as well as both hands which inc w/extension of arms;
second booster, pt reported a burning sensation at injection site at time of injection. pt called and wanted us to report this side effect as they state the burning did not occur for previous doses. burning subsided quickly after injection.
Patient became very weak-Patient was placed in a dental chair with feet elevated Hypotentention- Provided patient with water and blood pressure was closely monitored Bradycardia - EKG showed sinus brady Syncope episode- patient was placed in dental chair and blood pressure was monitored
Extreme digestive pain on same day as first dose.  Diarrhea last about two days.  Digestive upset lasted two weeks.  Milder stomach pain and cramping every time I ate food of any kind for two weeks.  Metallic taste - appeared 2 days after 1st dose- still present today Decreased taste and smell - appeared 1 day later -still present today  Breast tenderness few weeks later with menstrual cycle - cycle is now over and breast tenderness still present today. ( NEVER had breast tenderness before with menstrual cycle.)  Depression - about 1 week after 1st dose.  Depression was so bad didn't hardly get off couch for days.  Depression is getting better but still present today.
this is one of 2 pt from this site to esp inconsolable crying for 3-4 hr after recv vax.
8/21/2023 6:10 AM       Notified by nursing regarding: worsening cough   Patient is here with covid and is on IVF. Will get a CXR to ensure no pul edema and will order robitussin. Morning HBS to follow up on the CXR     Electronically signed by  DO   8/21/2023   6:10 AM.         Note Details  Author  (D.O.) File Time 8/21/2023  6:11 AM Author Type PHYSICIAN (D.O.) Status Signed Last Editor (D.O.) Specialty Hospital Medicine Hospital Acct #  Admit Date 8/17/2023  ED to Hosp-Admission (Current) on 8/17/2023  ED to Hosp-Admission (Current) on 8/17/2023   Detailed Report  Note shared with patient Care Timeline  08/18   Admitted from ED (Observation) 0038 08/20   Admitted 1053
I have been diagnosed with Shingles (head and face)  25 days after receiving my 2nd  Covid Vaccine . I have been a very healthy active person my whole life. I do believe the covid vaccine was related to the shingle outbreak.
I randomly got hives and its lasted about 2 weeks now. Once the Benadryl runs out then I start to feel an itch and the itch leaded to that whole area red and bumpy. The only thing I have gotten so far is a steroid and Benadryl. only thing that works is the Benadryl.   When I first went into the ER I went because I got hive and ive never had hives before in my life.   I went 3 days later because I had a migraine, felt sick and had trouble swallowing.
Symptoms starting and worsening over 3 days:  Fatigue, chills, cough, sore throat, sinus drainage, low-grade fever, nasal and chest congestion, muscle aches, extreme sleepiness.  I have *not* visited my doctor nor any clinic. On Day 3, I  got a Covid-19 test at my local pharmacy, which came back NEGATIVE. I self-treated with Mucinex DM, cough drops, and NSAIDS. After 7 days, I switched to regular Mucinex tablets (without DM) and the sleepiness went away. (I had discovered that dextromethorphan reacts with my Fluoxetine, so discontinued it). It is now Day 16 and I am still suffering chest congestion, nasal drainage, and severe coughing fits. On about Day 10 or 11, I had a coughing fit so severe it caused a sudden extreme headache and vomiting. Since that night, I sleep sitting up to relieve the chest coughs.
Immediately dizzy, ringing in ears, excessively sweating and nauseous.  Treated with cold compress and water.  Better after 15 minutes. I have a history of fainting however it had been at least 5 years since that last occurred.
SUDDEN ONSET DIFFICULTY BREATHING; This spontaneous report received from a patient concerned a 52 year old female. The patient's height, and weight were not reported. The patient's past medical history included pleurisy, and complete hysterectomy, and concurrent conditions included penicillin allergy, sulfa allergy, rheumatoid, polyps in throat, non-smoker, non alcohol user, melanoma, and cancer survivor, and other pre-existing medical conditions included the patient did not have any abuse or illicit drug use. The patient received covid-19 vaccine (suspension for injection, intramuscular, batch number: 203A21A, expiry: UNKNOWN) dose was not reported, administered on 14-MAY-2021 for prophylactic vaccination. Concomitant medications included clozapine, diphenhydramine hydrochloride, prednisone, and salbutamol. On 15-MAY-2021, the subject experienced sudden onset difficulty breathing. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from sudden onset difficulty breathing. This report was non-serious.