chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Swollen Lymph node; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Swollen Lymph node) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Apr-2021, the patient experienced LYMPHADENOPATHY (Swollen Lymph node). At the time of the report, LYMPHADENOPATHY (Swollen Lymph node) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Relevant concomitant medications were not reported.  Treatment information was not provided.
Fever, chills, malaise, loss of appetite, aches, headache, lethergy.
Within 30 minutes of receiving the vaccine, I developed a headache followed by extreme fatigue, both lasting for 3 days. I experienced alternating chills and sweats, but no fever, lasting for 2 days post-vaccine. I also experienced a small flare of my RA symptoms lasting for 2-3 days post-vaccine. I had no injection site reactions.   One week post-vaccine, I developed a small red lump at the injection site,. The next day, I developed another lump about half inch below the injection site. The lumps are red, slightly raised, hot to the touch, and itchy. If scratched, they produce a burning sensation under the skin. Left arm is achy (both at the injection site and down the length of the arm) and I am experiencing another small flare of my RA symptoms. Extreme fatigue has returned along with alternating chills and sweats, but no fever.
This was a vaccine administration error. The second dose of Moderna was administered to soon. First dose was given 03/20/21 and second dose was today 04/9/21. This is 20 days apart.
Received vaccine 10/22/2007@2:30pm. At 5:30pm had rash on arms legs and tops of feet. None on torso. Pt took Benadryl at home. Morning of 10/23/2007 pt still had rash and red cheeks. Physician at her work place gave Zantac and Loratidine. Wed AM 10/24/2007 pt had joint pain in wrists, elbows, knees and ankles.  Hands and ankles were swollen. Pt saw private physician and was given injection of Kenalog. Thurs 10/25/2007 after tx at Dr. office pt sx almost completely resolved.
Pt experienced drop in blood pressure and changes in HR. Pt received NS bolus and placed in supine position.
Hard to swallow, but I can swallow liquids.  Throat is swollen. Dizziness & chills. Not going to the ER unless it gets worse.
This spontaneous prospective pregnancy report as received from a medical assistant refers to a 28 year old female patient. In July 2017 the patient was vaccinated with GARDASIL 9 for prophylaxis.  Other suspect therapies included GARDASIL. Concomitant therapies included pre-natal vitamins and  iron pills. The patient became pregnant with last menstrual period (LMP) of 04-JUN-2017 and estimated date of delivery (EDD) of 11-MAR-2018. Initial exposure to GARDASIL 9 or GARDASIL was at 7 weeks. The pregnancy outcome was outcome pending. In July 2017 the patient experienced exposure during pregnancy. The outcome of exposure during pregnancy was unknown. The reporter considered exposure during pregnancy to be not related to GARDASIL 9 and GARDASIL.
Muscle aches, joint pain, nausea, vomiting, chills, fever, arm pain, fatigue, complete exhaustion,
Patient immediately felt lightheaded and nauseous, she needed to lie down and started sweating.  For the next 30 minutes she laid on the floor and drank water because she felt dizzy and like she would faint if she moved to sitting or standing position. Patient was laid on her back with a sweater under her head and her feet elevated on a chair.
headache since taking the second dose of the Pfizer Covid vaccine; This is a spontaneous report from a contactable consumer (patient) reported for himself. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of bnt162b2 on an unspecified date for covid-19 immunization. Patient had a headache since taking the second dose of the Pfizer Covid vaccine and wanted to know if he could take Tylenol or Ibuprofen, he read somewhere that he was not supposed to take one them. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Developed portal vein thrombosis. Clot was discovered incidentally during a gallbladder ultrasound.
Pt recvd vax & devel pain @ the inject site; In addition, exp pain radiating down the arm to hand & up neck as well as progressive weakness & morning stiffness in arm;
I experienced fever, chills, tiredness, and headache approximately five hours after administration of the vaccine on 3-10-21. Symptoms became severe within 30 minutes thereafter, at which time I experienced difficulty standing. After five hours with no improvement, I used my home blood pressure monitor to check my BP and HR; BP was high for me, 120/90 sustained, and HR varied between 135 and 150, with 143 being the most consistent value after multiple readings. I seemed to be experiencing a "severe allergic reaction" per the instructions I was given and called 9-1-1. I was transported to Hospital, treated in ER, and then admitted to the intermediate care unit. I was discharged to home on 3-12-21.
woke up w/several knotted & sore sites in muscles of rt shoulder-blade area (shot in rt arm);some shooting pain in scalp stopped p/2 days but knotted muscles painful;acupuncture/massage/heat helped;felt fatigue, dizziness w/tilt of head;
2/12 sudden onset of high fever, chills, myalgia, malasie, cough and clear sputum (x 1 week). One more week of fatigue left with irritable tracheobronch tree.  Desire to wheeze, no dyspnea, trachea hurt some with cough. 2/26 Vaccinated - no symptoms for two days 2/28 bad stabbing shoulder pain not related to exertion. Thought it was the joint, better with Naprosyn. 3/1 Naprosyn, shoulder pain mostly gone but radiation persisted.  Chest pain increased to neck while walking 3/3 Had to work, increasing dyspnea and chest pain increased to neck and shoulders 3/4 Went to MD, EKG with T Wave and was admitted to hospital.  Follow up 11/04/2003: "Vaccine recipient did recover from adverse event."  Follow up on 07/28/04 states: "Pt has recovered from adverse events."
day of vax pt devel large red splotches over entire body; warm to touch; temp 98.3; treated w/benadryl
elevated heart rate of 100-108, around 100 beats per minute; Fatigued; This is a spontaneous report from a contactable consumer (patient's daughter) via medical information team. A 65-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown, Expiration date: Unknown), via an unspecified route of administration, administered in left arm on 04Mar2021 at 16:45 (at the age of 65-years-old female) as single dose for COVID-19 immunisation. History of all previous immunization with the Pfizer vaccine considered as suspect was none. No additional vaccines administered. No prior vaccinations were given within 4 weeks. Medical history included ongoing hypertension (the patient has been taking metoprolol for years, maybe 10 years). Family medical history was none. Concomitant medication included metoprolol taken for hypertension from an unspecified start date and ongoing. On an unspecified date of Mar2021, the patient experienced elevated heart rate of 100-108, around 100 beats per minute and fatigued. Reporter stated her mother received the first dose on 04Mar2021 and was scheduled for the second dose on 25Mar2021 and experienced an elevated heart rate of 100-108 after the first dose. She would like to know if the elevated heart rate two days after vaccination has been reported and if there was a recommendation for the second dose, She stated her mother takes metoprolol which was supposed to lower heart rate instead of elevating your heart rate. Reporter stated that the patient experienced an elevated heart rate for 2 days following the first dose of the Covid-19 vaccine. Elevated heart rate: Reporter stated reported that right after the patient received the first dose of the Covid-19 vaccine, within 24 hours, she began experiencing an elevated heart rate. Reporter stated that the patients resting heart rate while it was elevated was around 100 beats per minute. The events did not result in emergency room or physician office. The events were considered as non-serious by reporter. The outcome of the events was recovered on an unspecified date of Mar2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
HEALTH PROBLEMS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A, and expiry: UNKNOWN) dose was not reported, administered on 18-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the subject experienced health problems. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of health problems was not reported. This report was non-serious.
This case was reported by a nurse via other manufacturer and described the occurrence of injection site pain in a female patient who received SHINGRIX for prophylaxis. Co-suspect products included ORENCIA for product used for unknown indication. Previously administered products included SHINGRIX with an associated reaction of injection site pain (1st dose, refer case US2019GSK019571) and XELJANZ. On 4th January 2019, the patient received the 2nd dose of SHINGRIX and ORENCIA. On 5th January 2019, 1 days after receiving SHINGRIX, the patient experienced injection site pain, injection site swelling, fever and chills. The patient was treated with diclofenac sodium, TYLENOL and BACLOFEN. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the injection site pain, injection site swelling and chills were unknown and the outcome of the fever was not recovered/not resolved. It was unknown if the reporter considered the injection site pain, injection site swelling, fever and chills to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. On 4th January 2019, the patient also received ORENCIA. After receiving SHINGRIX, the patient experienced a sore, swollen injection site, fever of 102 degree F and chills. The patient had no rash, difficulty breathing, or signs or symptoms of chest congestion. The patient took one TYLENOL, a diclofenac tablet, and a BACLOFEN but still had fever. She also received TYLENOL 500mg tablets when she was advised to receive one 500 mg tablet but did not receive more TYLENOL for at least 6 hours. The patient was advised if symptoms would not get better by tomorrow contact the ORENCIA prescriber for evaluation of possible infection.
No adverse event; HCP stated they accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (HCP stated they accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage) and NO ADVERSE EVENT (No adverse event) in a 43-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7664B) for COVID-19 prophylaxis.     No Medical History information was reported.    In August 2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. In August 2023, the patient experienced ACCIDENTAL UNDERDOSE (HCP stated they accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (HCP stated they accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage) 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 assessment was provided for ACCIDENTAL UNDERDOSE (HCP stated they accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage).    Concomitant medications were not reported.  No adverse event was reported for any of the patients.  Treatment medications were not reported.    This case was linked to US-MODERNATX, INC.-MOD-2023-738766 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 29-Aug-2023: Live significant follow-up received: Patient age, initials, gender and new references added.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-738766: (Master Case)
Day 1:arm pained him to point he couldn't raise or use it. He felt dizzy also. Day 2:rash formed at injection. fever. arm in sling. Starting Cephalexin for suspected infection of injection site. Day 3:rash larger. fever of 103.2. Rash in shape of deltoid muscle, not circular.
Received ZOSTAVAX on 5/10/17. Called 5/12/17 to say site redness approx 3-4 inches in diameter. No itching or soreness.
I was a little tired that night of the vaccine and the next day too, but then around 5 pm the next day I just felt I had a fever didn't take temp got flushed and hot my face turned red. Total malaise and exhaustion until about nine. Then my fever dropped redness went away drank water. I may have taken Tylenol 1000mg.
Arm was sore; rash locally at the injection site that lasted a week; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm was sore) and VACCINATION SITE RASH (rash locally at the injection site that lasted a week) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032B21A and 0361321A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, the patient experienced VACCINATION SITE PAIN (Arm was sore) and VACCINATION SITE RASH (rash locally at the injection site that lasted a week). At the time of the report, VACCINATION SITE PAIN (Arm was sore) and VACCINATION SITE RASH (rash locally at the injection site that lasted a week) had resolved.            No concomitant medication was reported.  Treatment drugs included steroids.   This case was linked to MOD-2022-437867 (Patient Link).
Information has been received from a consumer concerning her 16 week old daughter, who in September 2007, was vaccinated with the first dose of PEDIARIX and PREVNAR, which were well tolerated. On 30-NOV-2007, her daughter was administered the second dose of Hib conj vaccine (lot #656517/0257U), of PEDIARIX and of PREVNAR. On 01-DEC-2007 the infant developed a low grade fever. Within 48 hours, (approximately on 03-DEC-2007), her temperature had spiked to 103 degrees, and her neck was swollen, with the lymph nodes swollen "almost to the size of a golf ball," and she was hospitalized. Blood tests were performed (tests not specified, and results not provided). She reported her daughter was hospitalized for 6 days, and currently was recovering, but had also developed diarrhea. No further details were provided. No further information is expected.
He experienced swelling in the parotid gland around the jaw; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (He experienced swelling in the parotid gland around the jaw) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     Concomitant products included APIXABAN, METFORMIN, ROSUVASTATIN CALCIUM and CETIRIZINE for an unknown indication.   On 09-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, the patient experienced LYMPHADENOPATHY (He experienced swelling in the parotid gland around the jaw). At the time of the report, LYMPHADENOPATHY (He experienced swelling in the parotid gland around the jaw) was resolving.            No treatment medication reported
After the vaccination I experience soreness at the site and muscle pain in raising my arm to the side with the arm straight and also in an angle of 45 degrees to the front. I can not turn my body and lift the arm comfortably. I noticed that the area that i was injected was very painful and sore and has not stopped hurting since the time of the injection.
This spontaneous report was received from a nurse practitioner (also a regional director) via Pfizer (2017386685) refers to a male patient of unknown age. Patient's medical history, concurrent diseases and concomitant therapies were not reported. On 05-SEP-2017 the patient was vaccinated with PNEUMOVAX 23 one injection (dose, lot number, expiry date was not provided) for vaccination (immunization). On an unknown date, the patient also vaccinated with other suspect of PREVNAR 13 (lot number, expiry date was not provided). The reporter clarified that the patient already received 3 doses of vaccine. On 05-SEP-2017, the patient was administered PNEUMOVAX 23 instead of PREVNAR 13 (wrong product administered and interchange of vaccine products). The reporter considered that events reported in this case as Serious as medically significant.
3/7/2021  at 2am  woke with liquid diarrhea, nausea and vomiting, and severe headache.  She took Advil once late afternoon 3/7.  Headache lasted a couple of days.   Vomiting lasted 24 hr.  Three liquid diarrhea stools/hr for 24 hr, then liquid stools approx once every hour to hour and a half.  Started Imodium on 3/9 and continued to have  liquid diarrhea stools 5-6 times in 24 hours.  Reports significant bloating and gas.   Last Imodium dose 3/12.  Diarrhea stopped 3/13.   She had severe fatigue from 3/7 until 3/13.
breasts were sore; swollen lymph nodes in her neck area and armpits; This is a spontaneous report from a contactable consumer (the patient) received via a sales representative. A 66-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number not provided), via an unspecified route of administration on 16Feb2021 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient noticed that by day 4 post shot (20Feb2021), her breasts were sore, and she was experiencing swollen lymph nodes in her neck area and armpits. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number could not be obtained.
This spontaneous report was received from a nurse refers to unspecified patients of unkonwn age and gender. No pertinent medical history was reported. Since 05-JAN-2015, the patients was vaccinated with VARIVAX (Merck) (strength, dose, lot # were not reported) which were exposed to supported temperature excursion. Concomitant therapy was not reported. No adverse effect was reported. This is one of the two reports from the same source. Additional information has been requested.
Patient rec'd shot on Sunday. Had local reaction to begin with, arm swollen in area and sore. Soreness left on Wednesday June 9th. However, patient is stating hearing loss began Thursday June 10 and has continued. I called Moderna customer rep and stated that this was not a normal or to-be expected adverse effect of their vaccine. Patient would not authorize me to release any additional information to Moderna. I cautioned patient to visit a physician if symptoms did not resolved in next 48 hours.
On Wednesday April 7, 2021 client received her second dose of Pfizer COVID vaccine (LOT # EW0150, EXP 7/2021) at approximately 3:08pm. Per EMT report, he was called over to the parking lot d/t client stating she was feeling a sensation of "numbness in her left arm" after receiving her second dose. Client stated to EMT she experienced no reaction from her first dose. Client was brought back to Observation Area where she was seated in a chair and vitals were taken. Vitals at 3:27: BP: 134/68, HR: 78, O2 sat: 97%. After five minutes client stated to EMTs she felt no other symptoms and that her numbness "was improving." At 3:30pm, EMTs offered client water but she refused. Client stated to EMTs she desired to leave as she stated she felt her symptoms were subsiding. Patient was alert and oriented x4 during entire interaction. No further interventions indicated. Client was educated by EMTs on signs and symptoms of adverse reactions and when to go to the ED/call MD. Client was also encouraged to sign-up on v-safe. Client left vaccination site with a steady gait at approximately 3:40pm.
COVID 19; COVID 19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 74 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: It was reported that patient received other medication in 2 weeks.Treatment start date was reported 06Jan2023 and treatment stop date was 07Jan2023.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Grand mal seizure. Transported to hospital. Intubated and flown to another facility.