chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Expired ACT-HIB was administered to a patient with no reported adverse event; Initial information received on 24-Mar-2023 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional.  This case is linked to case 2023SA096953.  This case involves a 3 months old male patient and reporter reported that an expired HIB (PRP/T) vaccine [ACT-HIB] was administered to a patient with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.  On 20-Mar-2023, caller reported that 0.5 ml (milliliter) (1x) (once) of an expired HIB (PRP/T) vaccine, powder and solvent for solution for injection (lot UJ649AAA, expiry date: 05-Mar-2023) (Strength: standard) via intramuscular route in the thigh NOS for immunization was administered to a patient with no reported adverse event (expired product administered) (latency: 1 same day).   No lab data were reported.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Patient was administered FLUVIRIN and PNEUMOVAX. After 5 min. patient began complaining of trouble breathing and chest pressure. Also complained of pain in the knees. One dose of Epi was administered (EPI PEN). Improvement after 3-5 min. Patient was taken to ER by paramedics.
Yellow Fever vaccine diluted inadvertently with Sterile Water instead of the manufacture's required product (Sodium Chloride 0.9%). Administered SubQ left arm.
Booster for Covid vaccine; Arm was sore to the touch; dizziness; fatigue; chills; headache; fever; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 72 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1 , Manufacturer : Unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose 2 , Manufacturer : Unknown), for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "Booster for Covid vaccine"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Arm was sore to the touch"; DIZZINESS (non-serious), outcome "unknown", described as "dizziness"; FATIGUE (non-serious), outcome "unknown", described as "fatigue"; CHILLS (non-serious), outcome "unknown", described as "chills"; HEADACHE (non-serious), outcome "unknown", described as "headache"; PYREXIA (non-serious), outcome "unknown", described as "fever".  The lot number for bnt162b2 was not provided and will be requested during follow up.
I slowly developed increasing tachycardia and chest pain that persisted months and ultimately let to an admission in August of 2021. Leading to a full cardiac work up and being placed on cardiac medication. Today 1/31 I am admitted for the same reason. I have never had any cardiac issue prior to the vaccines. Now I am very nervous about the booster that my job is mandating for employment and has basically told it?s practitioners not to write a medical exemption form.
Starting the morning after receiving the vaccination, I slept for almost nine straight hours.   I didn't have any pain or feel bad.
Low grade fever approximately 24 hours after injections. High fever 101-103 and meningitic exam 48 hours after exam. Positive some oral ulcers. Admitted to hospital. Full sepsis work up and LP done. Pt very irritable for over 5 days, gradually improved. The hospital discharge summary received on 1/6/04 indicates final diagnosis of aseptic meningitis. Symptoms were fever, decreased PO intake, crankiness, and clear rhinorrhea.
Day 1) sore arm. Day 2) Sorer arm, mild headache, later in day 2, upset stomach, diarrhea,  stayed home from work Day 3) mild to moderate headache, nausea, periods of dizziness, chills, no fever but temp slightly elevated. Day 4) Severe headache, nausea, vomiting, chills, very sleepy, brain fog.  Day 5) moderate to severe headache, still very tired and nauseous, dizziness. Day 6) mild to moderate headache, stomach cramps, nausea, cold sweats, periods of dizziness, brain fog. It has been nearly a week, I still do not feel "right".
After vaccine sore arm and pain in lefr arm.next day chills ,muscle aiche,sore trouught,and headache.3rd day 24/7 headache that did not stoo with any pain relive medication and tiredness.the headache lasted for 12 days and after it stoped my right leg is week and my toes get numb and my leg.i have a muscle pain in that leg that does not stop.today also started in the hands the weekness amd numbnees that comes and goes.
Information has been received from a pharmacist concerning a patient of unknown age and gender. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (lot #, dose and route was not provided). No other co-suspects were reported. No concomitant medications were reported. On an unknown date, the patient received ZOSTAVAX that did not look normal in terms of the lyophilized powder. No adverse event reported. No treatment information was reported. The patient's outcome was unknown. Additional information has been requested.
01/21/22 presents to ED for "Chest pain, SOB". PMHx of "depression, anxiety, insomnia, fibromyalgia, chronic migraines, recurrent C diff."
HA, Nausea, vomiting, wheezing (short duration) irregular heart beat, fever, chills, eyes burning, cough, sensitivity to light, bones aching and sore neck.
Leg was red and area around shot was swollen, patient was inconsolable for 2 hours; applied ice to leg and held against chest until fell asleep.
low fever (101F), body aches, head ache, sore left arm where shot was administered
some puffy eyes; swollen eyes; This is a spontaneous report from a contactable nurse (patient). A 68-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 20Jan2021 (Batch/Lot number was not reported; at the age of 68 years old) as dose 1, single for COVID-19 immunisation.  Medical history included that she was in the hospital due to penicillin. There were no concomitant medications. The patient previously took penicillin and experienced horrible rash (10-15 years ago she was in the hospital for a week after a drug reaction to penicillin). After receiving the first dose on 20Jan2021, the patient experienced some puffy eyes and swollen eyes in the evening and the next morning on 21Jan2021. Outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Back pain; This spontaneous case was reported by a patient and describes the occurrence of BACK PAIN (Back pain) in a  patient of an unknown age and gender 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BACK PAIN (Back pain). At the time of the report, BACK PAIN (Back pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were  provided. No Treatment information was  provided.
I took Sumatriptan 50mg 3 hours prior to vaccination because of a migraine attack. Migraine symptoms were relieved in 2 hours but still experienced some side effects of the medication such as dizziness. I got my 2nd dose of Moderna at 18:10, 2/17/21. I started to experience tingling sensation in my head at 23:00. The tingling was unilateral in the left parietal and left occipital areas. On 2/18/21, I experienced dizziness, fatigue, general weakness, bad headaches, and nausea. I took Acetaminophen 600mg at 22:00, and symptoms were gone on 2/19/20. But my migraines were more frequent since vaccination, but i did not take any medication for that. Today (2/22/21), some post vaccination symptoms are back, including headache, dizziness, fatigue.
pain on his arm; heart ache during deep breath; This is a spontaneous report from a contactable consumer received via a male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 03Mar2021 (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On 04Mar2021, the patient experienced pain on his arm and heart ache during deep breath. The patient was not treated for the events. The outcome of the event was unknown.  No follow-up attempts are possible; information about batch number cannot be obtained.
This spontaneous report as received from a pharmacist refers to a 60 year old female patient with drug reaction/allergy to codeine. On 25-SEP-2013 the patient was vaccinated with a dose of ZOSTAVAX, subcutaneously, dose unknown, lot # reported as J000440, expiry date reported as 11-APR-2014. Concomitant therapies included SYNTHROID and DIOVAN. On 26-SEP-2013 the patient experienced swelling, redness, burning and "feels warm to the touch", around the injection site, after receiving ZOSTAVAX. Pharmacist reported there was no rash. There was no treatment given. The patient sought medical attention by calling pharmacy. The outcome of adverse events was unknown. The relatedness between ZOSTAVAX and adverse events was unknown. Additional information has been requested.
16 hrs after vaccination, bilateral forearm and hand pain. 24hrs after vaccination; left sided facial asymetry and sole of left foot was itchy.  MR received documenting an ER admit for c/o new onset bilateral arm pain with difficulty in moving her hands, and dysthesias of both arms.  She was also noted to have a left-sided facial droop. Pt. was admitted to R/O stroke.  PE: WNL except slightly slurred speech, decreased sensation to light touch in the V2 distribution bilaterally.  Left facial droop with forehead sparing.  To follow up for facial droop in 1-2 weeks. No discharge dx. reported on D/C Summary. F/U report received from 11/02/2006 which notes improvement of all symptoms with the exception of a remaining slight facial droop. Assessment:  Left facial droop c/w central lesion (involving only lower 2/3rds). + risk factors for CVA of HTN, but this is well-controlled.  DDX would be small CVA not yet detected on CT & MR vs vasculitis.
Brain fog; Depression; Fatigue; Weak; Fever; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration on an unknown date in 2021 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. Medical history included hepatitis C (Hep C). The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received other vaccine within four weeks prior to the vaccination. Concomitant medication included influenza vaccine (MANUFACTURER UNKNOWN) on 20Sep2021 for immunization. On 24Oct2021, the patient experienced brain fog, depression, fatigue, weak and fever. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events and included treatment with paracetamol (TYLENOL), dextromethorphan hydrobromide, guaifenesin (MUCINEX DM), plenty of water and sleep. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events brain fog, depression, fatigue, weak and fever was resolved on an unknown date in Oct2021.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Patient reports 16 hours post immunization strong headache, fever, malaise, & concern of difficulty breathing d/t throat constriction. She did not self medicate or seek medical help & symptoms were relieved 12 hours post.
His arm was sore, and that was it.; The Booster was given on 27Sep2021 at 2 pm.; This is a spontaneous report from a contactable consumer(patient) reported for himself that: A 80-years-old male patient received third dose of bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot Number: FF8839) via an unspecified route of administration, administered in Arm Left on 27Sep2021 13:30 (Age at Vaccination 80-years-old) as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunization.Medical history included , tonsillitis from 1952 to an unknown date Pertinent details : Surgical Removal , appendix disorder from 1955 to an unknown date Pertinent details : Surgical Removal , vasectomy from 1974 to an unknown date Pertinent details : Surgical , colon cancer from 19Dec1997 to an unknown date Pertinent details : Surgical Removal portion of colon , hernia repair from 20May2005 to an unknown date Pertinent details : Surgical Repair , prostate cancer from 16Nov2011 to an unknown date Pertinent details : Surgical Removing of prostate , hernia repair from 12Nov2011 to an unknown date Pertinent details : Surgical Repair. There were no concomitant medications. Previously patient was received First dose of bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot Number: EL9263) via an unspecified route of administration, administered in Arm Left on 28Jan2021 11:30 AM (Age at Vaccination 80-years-old) as DOSE 2 SINGLE for COVID-19 immunization. second dose of bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot Number: EL9267) via an unspecified route of administration, administered in Arm Left on 27Sep2021 10:10 AM (Age at Vaccination 80-years-old) as DOSE 2 SINGLE for COVID-19 immunization. On 27Sep2021 17:00 the patient experienced his arm was sore, and that was it, the booster was given on 27sep2021 at 2 pm. (immunisation) on 27Sep2021 14:00. The outcome of the event His arm was sore, and that was it was recovered on 29Sep2021.The outcome of the event The Booster was given on 27Sep2021 at 2 pm was unknown.  Follow-up attempts are completed. No further information is expected.
Information has been received from a physician concerning a female with no pertinent medical history or no drug allergies who on approximately 27-JUL-2008 was vaccinated intramuscularly with a 0.5 ml dose of GARDASIL (lot number was not known).  There was no concomitant medication.  On approximately 27-JUL-2008 the patient experienced pain in her arm around the site of injection.  The patient's pain in her arm around the site of injection persisted.  Medical attention was sought via telephone.  No product quality complaint was involved.  Additional information has been requested.
Vaginal bleeding after the booster shot.   I am currently breastfeeding and have not had a period since getting pregnant in April 2020
After numerous BMs same day, patient started having bowel movements with blood in the stool. He had 5 total dirty diapers that showed blood. The last one was at 3:00 AM Saturday morning 1/16 and there were no further symptoms. The baby had no other symptoms and was content.
Right shoulder pain; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Right shoulder pain) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Mar-2021, the patient experienced ARTHRALGIA (Right shoulder pain). At the time of the report, ARTHRALGIA (Right shoulder pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.   No treatment information was provided.
Pt passed out after blood draw and vaccines HPV and MENVEO. 24 hrs later developed localized hives (L) upper arm down to elbow. PO BENADRYL and CLARITIN. Hydrocortisone topically.
I went into the ER at the end of June because of vaginal bleeding and they found out I was pregnant but the pregnancy was at an unknown location so they did a surgery, a laparoscopic surgery. That resulted in pregnancy removal and fallopian tube removal. Before the surgery they did a urine test and vaginal ultrasound. I went to the ER again because of bad breathing post surgery so they did a CT scan. They prescribed me hydrocodone and Ibuprofen.
Only experienced soreness at injection site for about 4 days.  Symptom fully subsided. Experienced a delayed reaction starting on day 11 which presented as a small red splotch. On the morning of day 12, redness spread and mild swelling occurred.  Arm soreness reappeared. On day 13, redness spread a bit and mild soreness remained, swelling subsided. All symptoms completely subsided on day 14, skin in that area only mildly itches.
Chills first, starting at 10 am next day; then headache starting about 11 am; fever of 101 by noon. All lasted through 2 doses of Tylenol, and one dose of Advil, until around 7:30 pm.
redness at the injection site; swelling at the injection site; fever; joint pain; flu like symptoms; This case was reported by a nurse via sales rep and described the occurrence of injection site erythema in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th July 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than a month after receiving Shingrix, the patient experienced injection site erythema, injection site swelling, fever, joint pain and influenza-like symptoms. On an unknown date, the outcome of the injection site erythema was unknown and the outcome of the injection site swelling, fever, joint pain and influenza-like symptoms were recovered/resolved.   The reporter considered the injection site erythema to be related to Shingrix. It was unknown if the reporter considered the injection site swelling, fever, joint pain and influenza-like symptoms to be related to Shingrix.  Additional information received were as follows: The reporting licensed practical nurse was the concerned patient. The age at vaccination was not reported but it could be 69 years or 70 years. The lot number was unknown. The patient also had a low fever of 100 degree F, joint pain and flu like symptoms that lasted 3 days. The patient was not hospitalized. This case has been linked with US2019146763, reported by the same reporter.      Lab Comments: On an unknonw date, the patient's body temperature was recorded as 100 degree F.
On 02/03/2023 I received my Covid-19 vaccine. On 03/12/2023 I noticed my left lower eye was blood red. Throughout the next days the entire eye was red. After reaching out to my doctor I was diagnosed of a sinus infection and said I had a busted blood vessel in my left eye. I was prescribed AUGMENTIN and eyedrops. Symptoms ongoing.
Fainting after receiving TIV administration. No LOC; after 1-2 minutes, alert/oriented/quiet; No SOB, no hypotension. VS stables x 5. Treatment: supine x 20 minutes, legs elevated, rest, close observation, monitoring for sx/s allergic reaction.
Delayed-onset localized reaction to one of the above vaccines (given in the same arm). Injection site with redness, swelling and warm to touch.
Following my second dose of Phizer I?ve developed severe dizziness following  the exercise at the gym, at night symptoms worsened and affected by  coordinations and stability. I was taken to a&e firstly with suspicion of stroke  but following medical assessments I was diagnosed with paroxysmal positional vertigo.
Initially no reaction.  Vaccinated in the morning, played golf in the afternoon.  Early evening began experiencing shortness of breath, which became severe in a short period of time.  Called 911.  Paramedics arrived and administered care and transported me from my home to the  Medical Center emergency room.
The patient received vaccine after being more than 30 days stored in the fridge; No adverse event; 40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED DEVICE USED (40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored), PRODUCT STORAGE ERROR (The patient received vaccine after being more than 30 days stored in the fridge) and NO ADVERSE EVENT (No adverse event) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005c21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 16-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Aug-2021, the patient experienced EXPIRED DEVICE USED (40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The patient received vaccine after being more than 30 days stored in the fridge) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED DEVICE USED (40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored), PRODUCT STORAGE ERROR (The patient received vaccine after being more than 30 days stored in the fridge) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED DEVICE USED (40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored) and PRODUCT STORAGE ERROR (The patient received vaccine after being more than 30 days stored in the fridge).    It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Concomitant product use was not provider by the reporter.  The vaccines were stored in the fridge on 30-Jun-2021. Best used date was reported as 30-Jul-2021. Doses were administered between 02-Aug-2021 and 20-Sep-2021. Patient did not report any side effects.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-698994 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-698994:Master Case ID
Red warm to the touch localized area at injection site. BENADRYL given in office and Hydroxyzine 2.5 ml PO 4 times a day for 14 days and Triamcinolone acetonide cream 0.1% apply topically twice a day for 7 days as needed was prescribed.
t99.8 ax; devel rash & swelling around noon on next day p/inject; mom states rash appeared as red "long" blotches on body & progressed to face the next morning; MD did not feel was vax rxn; mom reports throat red & swollen;