chrisvoncsefalvay/vaers-outcomes huggingface dataset:
a dose of Shingrix was administered to a patient / the dose was not storage under correct temperature conditions /  it was outside recommended temperature range; This case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug 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, unknown after receiving Shingrix, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The pharmacist reported that, a dose of Shingrix was administered to the patient and the dose was not stored under correct temperature conditions, which led to incorrect storage of drug. The health care professional did not want to provide patient's identifiers nor lot/expiration date of the vaccine. Storage conditions were not provided, just mentioned it was outside recommended temperature range for more than 72 hrs (probably 4 days). The reporter did not consent to follow-up.
I had the MMR vaccine on Thurs.Aug.14,2003.By Friday I had injection site swelling and redness,the site was very warm.I ran a fever for 2 days but my main concern was my glands on the left side of my neck were swollen and very tender and painfull up through to my ear.I had a hard time even chewing food because of the pain on my left side,I called my local e.r., they recommended benadryl,if that didn't help to come in.The benadryl did help,i have no med.coverage.Just thought I'd let you know, because it was a scary couple days for me,the glands are still somewhat swollen,but better than they were.
Sometime that night after I got the shot I started getting a headache when I woke up the next day it was very severe. I eventually stopped work because my head was pounding. For the rest of the afternoon that day I felt very clammy and sweaty and warm. I got out of bed at 8pm to shower and at that point is when I got dizzy and fainted. I took Tylenol that afternoon for the headache. I went to urgent care the day after I fainted because my toe was very bruised from fainting and they found a fracture.
This spontaneous report was received from a licensed practical nurse and refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 24-MAR-2016, the patient was vaccinated with the first dose of the vaccination series, GARDASIL (route of administration, lot number and expiry date were not reported). On 28-JUL-2016, the patient received the second dose of the vaccination series, GARDASIL 9 (intramuscularly, dose: 0.5 ml, lot# L048459, expiry date: 22-FEB-2018). No concomitant therapy was reported. No adverse effect was reported. The patient's outcome was not reported. Relatedness between the adverse event and vaccination with GARDASIL and GARDASIL 9 was not reported. Additional information has been requested.
After, receiving the shot i started experiencing a rash on back of neck, arms and face, which left me dry and itching.
Pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain at the injection site) 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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Pain at the injection site). At the time of the report, VACCINATION SITE PAIN (Pain at the injection site) outcome was unknown. Not Provided          Concomitant medications were not reported. Treatment medications were not reported.    Reporter did not allow further contact
This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 66-year-old female patient who received SHINGRIX (batch number 3AF9E, expiry date 2nd February 2021) for prophylaxis. Concurrent medical conditions included shingles and neuropathy in head. On 28th June 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 28th June 2018, less than a day after receiving SHINGRIX, the patient experienced headache and pain in arm. On 29th June 2018, the patient experienced influenza-like symptoms, erythema, weakness, fever, chills, nausea and skin discoloration. The patient was treated with ibuprofen, medication unknown (Ice Pack (Nos)), prednisone and benadryl (nos) (Benadryl). On 30th June 2018, the outcome of the influenza-like symptoms, headache, pain in arm, weakness, fever, chills and nausea were recovered/resolved. On an unknown date, the outcome of the erythema and skin discoloration were not recovered/not resolved. It was unknown if the reporter considered the influenza-like symptoms, headache, erythema, pain in arm, weakness, fever, chills, nausea and skin discoloration to be related to SHINGRIX. Additional details were received as follows: On the vaccination day, at 2:00, the patient experienced headache. On the next day at 2:00, the patient experienced flu like symptoms which were described as weakness, fever, chills, nausea, and spending 3/4th of the day in bed. The patient took Ibuprofen every 8 hours for flu like symptoms. The patient used Ice for left arm pain. The reporter noted a purple reddish circle appeared closer to her left shoulder and purple, reddish circle to her lower arm. On 29th June 2018, the reporter saw her physician and was prescribed Prednisone, 50mg of Benadryl, and instructed to continue using ice. The reporter provided lot number 3AF9F, but noted the last letter could also be an 'E', could not specify. However, the batch number was corrected to 3AF9E as per the sales database. The first name of the pharmacist who administered the vaccine was unknown. The details of the physician was provided.
Bruising, blood spot under skin and spreading to lower arm, yellowish skin in the upper arm.
burning/Injection site pain/ Injection site tenderness; swelling at injection site; could not move her arm; This case was reported by a consumer via call center representative and described the occurrence of injected limb mobility decreased in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 8th December 2021, the patient received the 1st dose of Shingrix (intramuscular) 50 µg. On 8th December 2021, immediately after receiving Shingrix, the patient experienced burning sensation. In December 2021, the patient experienced injected limb mobility decreased and injection site swelling. On an unknown date, the outcome of the injected limb mobility decreased, burning sensation and injection site swelling were unknown.   It was unknown if the reporter considered the injected limb mobility decreased, burning sensation and injection site swelling to be related to Shingrix.     Linked case(s) involving the same patient:  US2022038198  Additional details were provided as follows: The patient self-reported this case. The patient received vaccine into the muscle of her left arm. Immediately after the 1st shot of Shingrix, patient reported that she felt burning with the injection and pain at the injection site.  The reporter stated that, she could not move her arm for 2 days after the first dose and that she also had swelling and tenderness at the injection site. The reporter did not consent to follow up. For tolerance to 2nd dose, refer case US2022038198.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022038198:Same reporter
Pt received flu shot from local pharmacy on 8/27 & has had 5 days of chills, myalgias & fevers up to 101 in absence of any other causes.
she thinks it might have been blood or medication that run down; injection stung and kept stinging really bad; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE HAEMORRHAGE (she thinks it might have been blood or medication that run down) and VACCINATION SITE PAIN (injection stung and kept stinging really bad) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-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) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced VACCINATION SITE HAEMORRHAGE (she thinks it might have been blood or medication that run down) and VACCINATION SITE PAIN (injection stung and kept stinging really bad). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 10-Mar-2021, VACCINATION SITE HAEMORRHAGE (she thinks it might have been blood or medication that run down) had resolved. At the time of the report, VACCINATION SITE PAIN (injection stung and kept stinging really bad) outcome was unknown.            concomitant medication was not provided.
Pt bruise and numbness in arm started day of injection. Bruise is still quite apparent and dark today (9/18). Pt reported numbness from injection site down to the fingers. Pt stated numbness stopped 5 days after injection.
Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011M2DA and 025L20A) for COVID-19 vaccination.     Concurrent medical conditions included Type 1 diabetes mellitus. Concomitant products included INSULIN ASPART (NOVOLOG) and LISINOPRIL for an unknown indication.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 10-Feb-2021, PAIN IN EXTREMITY (Sore arm) had resolved.            No treatment medications were reported.   This case was linked to MOD-2021-346598 (Patient Link).
to ED c/o SOB, fever 101, fatigue, myalgia, O2 2lpm. TX: decadron, lasix, vit C, lovenox, zinc. Left AMA
Went to dinner with my boyfriend. Had pasta, nothing out of the ordinary. Around 11:30pm started feeling lethargic. He stopped me off. Had a slight tension headache. Went to bed, woke up around 2am sweating all over, extremely hot all over my body. My head was pounding. I took 800mg ibuprofen; 5 mg melatonin hoping i could go back to sleep.  While still in bed my sheets were laying across my neck and i could hear then moving. I thought the small refrigerator in my room was going out because odd this noise. After 20 minutes of trying to figure this out, I finally realised it was the sheet moving against my neck from my blood pressure.  This scared me so i put my smart watch on to check my blood pressure. I checked it 8 times holding the watch on the inside of my wrist and each tone it said it was in the high range. Thus then explained my extreme headache. I vomited once. Still in extreme pain around 3am I took 1 pill by mouth of midol which has acetaminophen hoping it would help and it did slightly bring down the feeling that my head was going to come off my body. My body felt like it had been hit. extreme fatigue, aches all ovee. The top of my body vent very heavy, i could hardly move myself. I ended up having to call out of work at 3:30am as my trip started at 7:00am.
Covid was expired. Patient received booster covid dose on 2/2/2022. Lot used expired on 1/15/2022. Provider spoke with parent and decided not to get another dose.
Pt. states that after receiving the 3rd dose of Phizer 10/08/2021, started experiencing symptoms 10/09/2021 @06:00pm violent chilling/seizure. Emergency Room transport/ treated for a "Mild" Heart Attack. Admitted to hospital 1 night treated with Heparin drip. Diagnosed with Myocarditis/Pericarditis, Granuloma in Both Lungs. Pericardial Infusion. Cardiologist visit Stress Echo preformed 01/2022, Murmur diagnosed. Pt. was not prescribed any follow-up medications, still experiencing symptoms as diagnosed.
Patient has lightheadedness and about to faint. Patient is given water and recovering right away.
No additional AE/; patient was administered an expired dose; This spontaneous report has been received from a physician assistant referring to a patient of unspecified age and gender. Information regarding the patient's medical history, concurrent conditions and concomitant therapies was not provided.  On 20-JUN-2023, the patient was vaccinated with an expired dose of hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) as prophylaxis (dose, route of administration, and anatomical site of vaccination were not reported; lot number W025778 has been verified to be valid, expiration date reported and established as 11-JUN-2023) (expired product administered).  No additional adverse event was reported (no adverse event).
back injury; This is a spontaneous report from a Pfizer. A contactable male consumer (patient) reported for himself. A 66-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EL8982 and Expiration date: unknown), via unspecifies route, administered in left arm (left upper arm bicep) on 18Jan2021 (at the age of 66-year-old) as 1st dose, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 08feb2021, the patient missed the second dose of vaccination which was scheduled due to a back injury. The patient did not receive treatment. The patient stated had his first dose of the vaccine last 18th of Jan. Supposedly, his second dose of the covid vaccine was 8th of Feb but couldn't do it because he had a back injury. On 08Feb2021 but missed his appointment because he was incapacitated from his back being shot. The patient stated he has been trying to reschedule his second dose on 09feb2021 with no success. The reported assessed the event as non-serious. The outcome of the event was unknown.  Information about lot/batch number was available. No follow-up attempts are needed.
gave the Fluzone HD, all of the vaccine didn't enter the Left Deltoid/ No AE; Pharmacist stated after giving the consumer their Fluzone HD injection the vaccine began to drip down their arm/ No AE; The vaccine liquid came out between the hub of the needle and the syringe on injection, It was the needle and not the syringe/ No AE; Initial information received on 23-Sep-2019 and additional information received on 24-SEP-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 74 years old male patient who did not received full dose of vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] lot UJ232AB via unknown route in the left deltoid on 23-Sep-2019, the vaccine liquid came out between the hub of the needle and the syringe on injection, it was the needle and not the syringe.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was a case of vaccine underdose, Exposure via skin contact and Needle leak.  At the time of report no adverse event was reported.  The leakage occurred during the injection of the Fluzone HD. Caller stated she placed the needle with the syringe in the arm and pushed the plunger. The vaccine liquid came out between the hub of the needle and the syringe on injection. Caller stated, "When she took the needle off of the syringe the needle looked wobbly and loosey goosey. Caller stated the needle didn't look right." 'It was the needle and not the syringe.  Documents held by sender: none.
Developed a rash on his scalp and belt line; This case was reported by a consumer via call center representative and described the occurrence of rash in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th May 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 10th May 2021, less than a day after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was not recovered/not resolved.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details provided as follows: The patient reported this case for himself. The patient experienced rash on scalp and belt line. The reporter did not consent to follow-up.
Adverse Reaction to Rt Arm symptoms Include tenderness, swelling Redness & Body aches Area measures 5x8cm
This spontaneous report as received from a registered nurse refers to a 14 year old patient of unknown gender. The reporter stated that it was discovered on 12-AUG-2014 that a patient who was outside of the age indication for PROQUAD (Merck) on 11-AUG-2014 received a dose of PROQUAD (Merck) (0.54 ml, subcutaneous, lot# J009048, expiration date: 31-JAN-2015, anatomical location was not reported). The reporter stated that another nurse saw that the patient was intended to receive M-M-R II and VARIVAX (Merck), and she administered a dose of PROQUAD to the patient without consideration of the age indications. It was reported that this error was not a result of medication confusion. It was a healthcare professional error. No adverse effect had been observed or reported. Additional information has been requested.
patient states that about 2-3 hours post vaccine arm became very swollen red , hot to touch and sore. Pt says that she iced and took Tylenol and day after is now much better
This spontaneous report as received from a other health professional refers to a female patient of unknown age. On 04-MAY-2013 the patient was vaccinated with PNEUMOVAX 23 (Lot # not provided) (dose and route not reported). No other co suspects were reported. No concomitant therapy was reported. On 08-MAY-2013, 4 days after the administration of PNEUMOVAX 23, the patient suffered swelling to the arm, at the injection site. The patient sought medical attention (saw the doctor). The outcome of the patient suffered swelling to the arm, at the injection site was unknown. Additional information has been requested.
Immediately after the vaccine the patient experienced muscle/arm soreness but nothing especially bothersome. However about a week later the patient noticed a red bump appear on her arm which later progressed into red patches/ bumps on various parts of her body. She showed me the bends of her arm which had a red rash and mentioned that a similar rash was also on her flank sides and armpit/breast area. She has been using OTC hydrocortisone cream which has provided minimal relief. She was advised to add BENADRYL allergy to her treatment regimen and to consult her primary care physician.
From telephone contact received on 3/7/02 at manufacturer, it was reported that a 5 year old male received 5th dose of Tripedia on 3/4/02. The patient complained of pain at injection site the next day and his mother noted redness from mid thigh down to the knee. On 3/6/02, local reactions: redness and warm to touch noted to the entire leg, from knee to upper leg. The patient is a little cranky but level of activity wasn't affected at that point. The redness has decreased on 3/7/02. Patient's left groin lymph node was swollen from 3/5/02 through 3/6/02.
DIARRHEA; SEVERE HEADACHE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included leukemia.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802070, and batch number: 1802070 expiry: UNKNOWN) dose was not reported, administered in the left arm on 09-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-MAR-2021, the subject experienced diarrhea. On 09-MAR-2021, the subject experienced severe headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the severe headache and diarrhea was not reported. This report was non-serious.
Right arm was very painful after receiving the tetanus vaccine on 10/29/2015 for the days leading up to 11/03/2015.  11/03/2015 I could not feel my arm, could barely move my arm, entire arm and shoulder hurt with pain down to my fingers, arm was very weak getting weaker each day, I started dropping light stuff when I tried to pick it up.  Notified my doctor who told me it sounded like Brachial Neuritis and to see a neurologist.  I saw Dr. who told me that my immune system was attacking my nerves due to the tetanus vaccine.  Presently in physical therapy.
Patient got first COVID-19 Moderna vaccine 4/9/2021. He states that within 5 minutes of getting vaccine, he had a metallic "copper-like taste" in his mouth.  The patient did have COVID-19 infection 11/2020 with fever but no hospitalization.  He did not have taste alteration during the infection.  Patient states the taste alteration he now has since vaccination on 4/9/2021 has NOT subsided for 28 days.  Worse in morning but persists throughout the day.
LEFT ARM INJECTION SITE: RED, SWOLLEN AREA CIRCUMFERENCE OF APPROX 3" IN DIAMETER. NO PAIN, ITCHING OR DISCOMFORT.   SUGG: ICE TO THE AREA AND OTC ANTIHISTIMINE. FOLLOW-UP:  12-5-06
Systemic: Chills-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Hypertension-Mild, Systemic: Shakiness-Mild
This spontaneous report as received from a medical assistant (M.A.) refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 01-SEP-2015, the patient was vaccinated with improperly stored VARIVAX (Merck), lot # L006383, expiration date: 25-FEB-2017 (dose and route unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Initial and follow-up information has been received from a physician concerning an 18 year old female with no pertinent medical history or drug reactions/allergies who on 13-JUN-2007 was vaccinated with Gardasil (Lot number unknown) 0.5 mL injection. There was no concomitant medication used. On 13-JUN-2007 the patient experienced dizziness. Medical attention was  sought. The patient recovered on 13-JUN-2007. Additional information was not provided. Additional information has been requested. This is in follow-up to report (s) previously submitted on 7/16/2007. It was reported as tranlent and lasted less than twenty minutes. The patietn was treated with cool cloths, sitting, and juice. The patient recovered on 13-Jun-2007. It was also reported that the patient stated that she did not eat breakfase that morning. Additional information is not expected.