chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Had eye swelling; Had / a rash; This case was reported by a consumer via call center representative and described the occurrence of eye swelling in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In July 2021, the patient received the 1st dose of Shingrix (intramuscular). In July 2021, less than a day after receiving Shingrix, the patient experienced eye swelling and rash. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the eye swelling and rash were unknown.   It was unknown if the reporter considered the eye swelling and rash to be related to Shingrix.  Additional details provided were as follows: The patient reported that he received the dose on 8th July 2021 or 9th July 2021 and the same day he experienced eye swelling and rash. The patient had started taking Benadryl to cope with the effects. Reporter consented to follow-up.
No additional AE/no PQC; Manager called to report dose of PROQUAD that expired 4/6/2023 was administered to patient on 5/31/2023. No additional AE/no PQC.; This spontaneous report was received from the Manager and refers to a 12-month-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 31-MAY-2023, the patient was vaccinated with an expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) subcutaneous injection, 1 dose, lot #U031560, expiration date: 06-APR-2023, administered for prophylaxis (strength, and route of administration were not provided). No additional adverse event (AE).
I had COVID in March and the symptoms I experienced were the same symptoms I experienced when having Covid but even more severe. I have chills, aches, fever and fatigue lasting from 8 pm the day of the injection and have not let up the next morning
allergy; axillary lump; shingles; tired; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (allergy) and FATIGUE (tired) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced FATIGUE (tired). On an unknown date, the patient experienced HYPERSENSITIVITY (allergy). At the time of the report, HYPERSENSITIVITY (allergy) and FATIGUE (tired) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       concomitant medications were provided.Treatment medications were provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-090139 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 28-May-2021: Followup was received and reporter contact information was updated.
Tired; Sore injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Tired) and VACCINATION SITE PAIN (Sore injection site arm) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Mar-2021, the patient experienced FATIGUE (Tired) and VACCINATION SITE PAIN (Sore injection site arm). At the time of the report, FATIGUE (Tired) and VACCINATION SITE PAIN (Sore injection site arm) outcome was unknown.            No concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD-2021-358235 (Patient Link).
This case was reported by a other health professional and described the occurrence of expired vaccine used in a 4-year-old patient who received ENGERIX B pediatric (batch number AHBVC190AA, expiry date 24th January 2015). On an unknown date, the patient received ENGERIX B pediatric. On an unknown date, an unknown time after receiving ENGERIX B pediatric, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown. No adverse event reported.
I had an initial bad reaction about 3 minutes after the injection almost passing out, severe nausea, dizziness overheating. Now I am experiencing terrible ringing in my ears (tinnitus).
Mother's report: DTAP (4th dose) given at approximately 9:10am. She cried for 10-15 seconds (usual for her) and was easily distracted and consolable right away.  She was more amused by the band aid than the shot.  We gathered our belongs and put pants back on her. We had not yet left the medical exam room when her behavior suddenly changed.  After approximately 5 minutes post injection, she became very lethargic and wouldn't let me put her down.  While I was holding her, she jerked 2-3 times and then vomited. (This appeared to be a seizure)  After that episode, she became somewhat unresponsive, very lethargic, and limp.  She could barely keep her eyes open.  The MD was called in. O2 Saturation and pulse were taken. Pulse was rather low (72 bpm). O2 sat were acceptable (I cannot recall exact %). She continued to be limp, pale, not communicating or responding to verbal commands. It was decided to call an ambulance.  Once the ambulance arrived (12-15 minutes later), her color was slowing returning and she was slowing acting more alert, but remained overall fatigued. This was a complete difference from prior to the injections when she was playing with several kids in the waiting room and running from toy to toy.  After this injection she was not interested in anything.  She was like a rag doll. Appeared to be in a postictal state. She was taken to the ER. Vital signs in the ambulance revealed a stable pulse, O2, with mild hypo-tension (93/37 - R ankle).  At the ER, she was examined, EKG performed and vital signs monitored.  She was slowly returning to her baseline. Vitals signs were stable. EKG negative. She was discharged home.
A consumer report has been received concerning a 4 years old, female patient. Patient's relevant history and concomitant disease were not reported. Patient's concomitant medication were not provided. The patient had been received FLUMIST QUARDIVALENT (intranasal) which was given on an unknown date. Consumer reported that his/her children received expired FLUMIST QUARDIVALENT on Monday and was now having flu like symptoms. Caller reported that patient had runny nose and coughing today on 13-Jan-2014. Caller stated patient received FLUMIST ata an after hours clinic, not at their regular pediatrician's office. The outcome of the event of flu like symptoms, runny nose, coughing, and received expired FLUMIST QUADRIVALENT was unknown. The reporter considered the events of flu like symptoms, runny nose, coughing to be non-serious. Event of received expired FLUMIST QUARDIVALENT identified and captured by the company physician as non-serious event.
I still have a cough and a cold but it's nothing like it's related to the covid; I have a little bit of cough; I did have a doubt of Covid approximately 19 days ago; I did have a doubt of Covid approximately 19 days ago; This is a spontaneous report from a contactable consumer (patient). A 65-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm on 24Mar2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE, dose 1 via an unspecified route of administration on 24Feb2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE (at the age of 65 years) for covid-19 immunisation. Medical history included diabetic, high blood pressure and a heart condition that's nothing changed from an unknown date and unknown if ongoing (I am a Diabetic, I have high blood pressure and I have heart condition that's nothing changed). Concomitant medications included immunoglobulin human normal (GLOBULIN); clopidogrel (CLOPIDOGREL); simvastatin (SIMVASTATIN); hydrochlorothiazide, losartan potassium (LOSARTAN HCTZ); furosemide (FUROSEMIDE); amlodipine (AMLODIPINE); metoprolol tartrate (METOPROLOL TARTRATE); aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]); paracetamol (TYLENOL); potassium chloride (POTASSIUM CHLORIDE); vitamin b [vitamin b nos] (VITAMIN B [VITAMIN B NOS]), all taken for an unspecified indication, start and stop date were not reported. The patient experienced  "I did have a doubt of covid approximately 19 days ago" in Sep2021. On an unknown date, patient still have a cough and a cold but it's nothing like it's related to the covid and have a little bit of cough. It was further reported that the patient received first and second dose of Pfizer vaccine and the second dose was in end of Mar2021 and this caller is 65 years old and over the 6 months, he wants to get the booster shot and apparently 19 days ago he had Covid or just it possibly Covid and a little bit cough. The patient paraphrased his concern and it is that he did have a doubt of Covid approximately 19 days ago and although, He didn't have Covid symptoms. He still have a bit of cough and a cold but it's nothing like, it's related to the Covid. His only concern, if he can get his third shot the booster shot with the fact that he had the Covid symptoms 19 days ago and I have a little bit of cough. The outcome of the events cold and cough was not recovered and unknown outcome for the other events.  The lot number for [BNT162B2], was not provided and will be requested during follow up.
sinus issues/sinus pain; This is a spontaneous report from a contactable consumer or other non hcp (patient herself). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection) via an unspecified route of administration on 14Jan2021 (Lot number and expiry date was not provided) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced sinus issues/sinus pain on an unspecified date. She had sinus issues and she was wondering if she could take a Tylenol due to the sinus pain not the vaccine. The outcome of the event was unknown.  Follow-up attempts completed. No further information expected.
he felt bad; Headache; Nausea; body aches; arm sore where he got the shot; 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), administered in arm left, administration date 25Apr2021 10:30 (Lot number: EW0167) at the age of 52 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset Apr2021, outcome "not recovered", described as "Headache"; NAUSEA (non-serious) with onset Apr2021, outcome "not recovered", described as "Nausea"; PAIN (non-serious) with onset Apr2021, outcome "not recovered", described as "body aches"; PAIN IN EXTREMITY (non-serious) with onset Apr2021, outcome "not recovered", described as "arm sore where he got the shot"; FEELING ABNORMAL (non-serious), outcome "not recovered", described as "he felt bad". Therapeutic measures were taken as a result of headache, nausea, pain, pain in extremity, feeling abnormal.  Additional Information: The patient stated that he had a headache for a couple days and nausea and body aches which have stayed about the same, they eased up, and came back that morning, it is like he has a hangover or something. He stated that his body aches and his arm was sore where he got the shot. He had been taking Ibuprofen, and the headache and aches was still lingering. Ibuprofen dose unknown. He was thinking that the dose might have been 800, though he had got some 200, he usually takes more, for this he just took one pill. He says he hadn't been to work because he felt bad. He said that his next shot is on 16-May and his first dose was injected 25-Apr at 10:30AM in his left arm.  No follow-up attempts are possible. No further information is expected.
Information has been received from a physician concerning 3 male patients who were vaccinated with doses of measles virus vaccine live, mumps virus vaccine live, rubella virus vaccine live, and have tested positive for the mumps after showing undisclosed symptoms.  Unspecified medical attention was sought.  No product quality complaint was involved.
Patient received dose on 5/7/21. She presented to the pharmacy 5/15/21. On 5/15/21, she was outdoors at a game and her arm started to itch. She was wearing lots of clothes to stay warm and wasn't able to look at her arm until she got home.  Upon inspection, her arm was swollen and slightly red. The inflammation began near the injection site and worked down the arm in the shape of an egg. The size was a little smaller than a tennis ball but larger than a very large egg. She is to contact me if swelling gets worse, but will be trying cool compress and diphenhydramine in the mean time.
Pain at injection site, headache, fatigue, muscle ache, nausea  As of 12/13/2022 still experiencing pain at injection site.
peeling like sunburn; slight inject site soreness; 2 circles appeared just above and below like a ringworm; dark rimmed, scaly, non itchy or painful red raised centers, above and below the inject site; This is a spontaneous report from a contactable nurse (reporting for herself).   A 72-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EN5318), via an unspecified route of administration on 02Feb2021 09:00 (at the age of 72) single dose left arm for covid-19 immunisation. Medical history included septicemia x2 15yr ago with hospitalizations (full recovery x2), oxygen therapy (full recovery x2), renal impairment and liver compromised (full recovery x2). Concomitant medication included oxybutynin hydrochloride (OXYBUTININ). No other vaccine was received in four weeks.  The patient experienced slight injection site soreness, 2 circles appeared just above and below like a ringworm, dark rimmed, scaly, non itchy or painful red raised centers, above and below the inject site, all on 06Feb2021, peeling like sunburn on an unspecified date. No treatment received. The outcome of peeling like sunburn was unknown, of the other events was recovered.
I received my 1st Pfizer Covid shot on 9/24/2021 and my 2nd Pfizer Covid shot on 10/16/2021.  I had not real reactions to the shot until Monday 10/25/2021 at which time I woke with pains in my lower left abdomen.  This did not go away for a number of days, and I was diagnosed with Diverticulitis by my doctor on Friday 10/29.  I have never had Diverticulitis in the past before taking the vaccine, and I'm currently taking antibiotics to treat the condition.  The pain from Diverticulitis has started fading, but is currently still there.
local swelling, erythema, pain at site, fever 101 on 1/22. Refused to ambulate & limp developed 1/23. Local reaction, fever, refusal to ambulate self-resolved 1/24.
Redness, swelling, heat to L upper arm. Erythema about 10cm. Per ER physician reaction vs. cellulitis, prescribed clindamycin for 30 days.
Puffy tongue  while waiting, Ulcerations on tongue during the night- lasting days and still reoccurring, Chest pressure- day after for a number of hours then subsided.  8 days after vaccine- injection arm burned and itched for a couple of days.  The other arm, neck and face also itched....
Patient has a presumed fever (shaking chills) and increasing shortness of breath that started this morning (1/4/2021)
pfizer vaccine had been in the fridge past the 30 days of safety at the time of administration. administering pharmacist was not aware of this at the time of administration. pt reported feeling fatigue and having a sore arm the day following vaccination.
muscle pain on the lateral side of right biceps extending to about 3 inches past right elbow; This case was reported by a consumer via call center representative and described the occurrence of localised muscle pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th July 2019, the patient received the 2nd dose of Shingrix. On an unknown date, less than 3 weeks after receiving Shingrix, the patient experienced localised muscle pain. On an unknown date, the outcome of the localised muscle pain was unknown.   It was unknown if the reporter considered the localised muscle pain to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient after receiving vaccine experienced muscle pain on the lateral side of right biceps beginning approximately 4 inches below the injection site and extending to about 3 inches past right elbow. The patient was aware that one of the side effects of the vaccine was muscle pain.
6/4/2023 - 6/7/2023 (3 days) dc home - Presented the hospital with shortness of breath dexamethasone, remdesivir  039B21A 4/28/2021 027C21A 5/27/2021 025L21B 2/4/2022
immediate pain, the red circle growing size of a cutie by morning, itchy, then lump,  seemed to subside and getting better after 5 days,, but lump on arm was hard like a tumor, Then  Thursday day 7 started getting red again ,more itchy, getting bigger now day 9 it's bright red again 2 1/4 in by 3 1/2 inch.
Patient admitted on 2/17 after noncardiac syncopal episode. He had recently gotten his first dose of Moderna on 2/15. He is normally ambulatory independently. He had mild rhabdo and was admitted from 2/17-2/19. DC'ed in stable condition.
No aditional AE reported; HCP reports that a three year old patient was accidently administered GARDASIL 9 on Jul 25, 2022.; This spontaneous report was received from a medical assistant referring to a 3-year-old patient of an unknown gender. The patient's pertinent medical history, concurrent conditions, drugs reactions or allergies and concomitant therapies were not provided.  On 25-JUL-2022, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) once, lot #1780876 has been verified to be a valid lot number with expiration date: 09-NOV-2023, administered for prophylaxis (strength, dose, anatomical injection site and route of administration were not provided) (product administered to patient of inappropriate age).  No additional adverse event (AE) reported (no adverse event).  This is one of two reports from the same reporter. ; Sender's Comments:  US-009507513-2207USA008060:MSD
Systemic: Fainting / Unresponsive-Medium, Systemic: FAINTING BUT ABLE TO HEAR & RESPONSE IN FAINT VOICE-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Visual Changes/Disturbances-Severe, Additional Details: AFTER ABOUT 5 MIN OF INJECTION, PT COMPLAINT THAT HE COULDN'T SEE ANYTHING. HE HAD MORE SWEATING & WEAK.  MOM TRIED TO WAKE HIM. HE DID RESPONSE IN FAINT VOICE. I HAD THE TECH CALLED 911 & I GAVE EPINEPHRINE INJECTION. FEW MINUTES LATER, HE SAID THAT HE COULD SEE. THE RESCUE MEMBERS CAME & MEASURED BP & HR WHICH WAS NORMAL SO THEY DIDN'T TAKE HIM TO ER. I CALLED MOM LATER & SHE SAID HE GOT BACK TO NORMAL. I ALSO TRIED TO FOLLOW UP FEW TIMES ON FOLLOWING DAYS BUT NO ONE ANSWERED THE PHONE.
13:37:  90BPM (140/100)One emesis, nausea, light-headedness, tired, fatigue; 14:41 70 BPM (114/80), headache pressure/tired
Nurse reported MMRII was administered after improper storage; MMRII Lot: U022983 Exp: 07/22/2023; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported.       On 03-AUG-2023, the patient was vaccinated with improperly stored and also expired measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) 1 dose, recombinant Human albumin (rHA) lot # U022983 with expiration date 22-JUL-2023, for prophylaxis (strength and route of administration were not provided). The vaccine was exposed to a temperature of 51°F for 1 hour. No previous temperature excursion was reported.
Onset of joint pain to hands and feet approximately 3 weeks later.  Pain has not improved.  No previous history of discomfort.
Patient noticed small rash around site, warm to touch itchy 3 days after injection. On 4th day rash spread wider diameter from deltoid to above elbow. Pharmacist called MD on 5/30 to report reaction. Dr saw patient and prescribed BACTRIM DS suspecting cellulitis.
Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 31-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.    In November 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In November 2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. The vial was initially stored in the refrigerator on 04-Nov-2021. Dates of administration of vaccine Some were on 05-Nov-2021 and the other doses on 12-Nov-2021. The vial did not undergone any temperature excursions. HCP stated, no adverse event occurred as a result of this misadministration, patients were monitored. No treatment medications were reported.
Systemic: Chills-Severe, Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Seizure-Severe
Caught Covid/ the husband got a mild case but the wife had a fever; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Caught Covid/ the husband got a mild case but the wife had a fever) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    In October 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Caught Covid/ the husband got a mild case but the wife had a fever). At the time of the report, COVID-19 (Caught Covid/ the husband got a mild case but the wife had a fever) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Did not get 4th dose but had 3rd dose on Oct2021.  No concomitant medications were reported. No treatment medications were reported.
Information has been received from a physician concerning a 12 month old male who on 5/1/06 was vaccinated with a dose of measles virus vaccine live  (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (+) varicella Virus Vaccine live (upgrade process) (lot 652231/0773R). 24 hours later, on 5/2/06, the patient experienced a fever of 104 degrees F. At the time of the report the fever had persisted. it was noted that the physician had ordered blood studies. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Additional information has been requested.
Mom c/o after pt got 1st HPV she noticed a nosebleed the following day & every day after for 1 mo. She states the same thing happened with pts 16 yo sib & denies either of them had nosebleeds before. Also denies other hematologic problems (prolonged bleed, etc).