chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine expired on 01-Apr-2022, stored in refrigerator on 04-Apr-2022 and administered on 18-Apr-2022; Received vaccine which expired on 01-Apr-2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received vaccine which expired on 01-Apr-2022) and PRODUCT STORAGE ERROR (Vaccine expired on 01-Apr-2022, stored in refrigerator on 04-Apr-2022 and administered on 18-Apr-2022) in a 58-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 18-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received vaccine which expired on 01-Apr-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine expired on 01-Apr-2022, stored in refrigerator on 04-Apr-2022 and administered on 18-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received vaccine which expired on 01-Apr-2022) and PRODUCT STORAGE ERROR (Vaccine expired on 01-Apr-2022, stored in refrigerator on 04-Apr-2022 and administered on 18-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was reported that the pharmacy received the vaccine on 23-Feb-2022. The reporter stated that, they thought vaccines will expire in Jun-2022 however vaccines were expired on 01-Apr-2022. The vial did not undergo any temperature excursion.  No treatment medications were reported.
Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Hypotension-Mild, Systemic: Nausea-Mild, Additional Details: patient sweating, feeling like she was going to faint BP was 98/64
BAD flu-like symptoms, severe headache, achiness, tired, runny nose, spiky fever/chills
Hot to touch; Injection site swelling; Injection site tenderness; Injection site redness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Hot to touch), VACCINATION SITE SWELLING (Injection site swelling), VACCINATION SITE PAIN (Injection site tenderness) and VACCINATION SITE ERYTHEMA (Injection site redness) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (Hot to touch), VACCINATION SITE SWELLING (Injection site swelling), VACCINATION SITE PAIN (Injection site tenderness) and VACCINATION SITE ERYTHEMA (Injection site redness). At the time of the report, VACCINATION SITE WARMTH (Hot to touch), VACCINATION SITE SWELLING (Injection site swelling), VACCINATION SITE PAIN (Injection site tenderness) and VACCINATION SITE ERYTHEMA (Injection site redness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were provided by reporter. No treatment information were reported.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Very sore arm, began to feel tired, warm and slightly achy all that evening. The next day feverish, very tired and very achy all over. A few days later noticed a red welt/ hive on my lower left stomach area, then a few days later on upper left rib cage area. rash began to spread over front torso area to chest, shoulders, back, and is continuing to spread to arms, legs and neck area! VERY, VERY itchy! On Oct. 21, 2013 in the morning I called the CDC information line and spoke with a representative to ask about possible side effects to flu vaccine. The rep said rashes not listed and may want to see a Dr. At 210 pm went to dermatologist and was diagnosis with pityriasis rosea. On medical website says "influenza viruses and vaccines have been associated with pityriasis rosea in some cases."
a bruise in the area of the left upper nose and left eyelid    between the nose and eye and including half of the eyelid
This spontaneous report as received from a health professional refers to a patient of unknown age and gender. On 06-FEB-2015 the patient was vaccinated with a dose of MMR II 0.5 ml, subcutaneous, (lot # not reported) that had undergone temperature excursions. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
He reports that his first  symptom started the same day and he received the vaccination around 3 pm.  He  started to feels symptoms around 8 pm pain around hip area bilaterally.  On the  following day he experienced upper back pain/shoulder pain/abdominal pain.  He  reports to intermittent feelings of bloating/constipation following vaccination  and took stool softeners which led to loose bowel movements.  About 4-5 days  after the vaccination the patient noted improvement in all his symptoms.
Caller stated the excursion lasted for 4 hours and 36 minutes. The maximum temperature of the refrigerator reached 53.6 degrees; Initial information received on 15-Apr-2022 regarding an unsolicited valid non-serious case received from a other health professional via call center.  This case involves a 19 years old female patient who experienced excursion that lasted for 4 hours and 36 minutes. the maximum temperature of the refrigerator reached 53.6 degrees for tuberculin test [Tubersol] .  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 11-Apr-2022, the patient received tuberculin test solution for injection 0.1 mL (batch lot - C58408A expiry date :30-Jun-2023)(unknown strength, route of administration and site of administration) for Immunization.  On 11-Apr-2022 excursion lasted for 4 hours and 36 minutes the maximum temperature of the refrigerator reached 53.6 degrees (product storage error) for poliomyelitis vaccine (inactivated) (IPOL). On an unknown date on Monday the patient received the vaccine and a non-serious event of excursion lasted for 4 hours and 36 minutes (unknown latency)the maximum temperature of the refrigerator reached 53.6 degrees (product storage error) following the first dose intake of tuberculin test.  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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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.
less than 18 years of age, patient received the vaccine.  No adverse symptoms known at this time.    Reporting medication/vaccine error
Diarrhea for 2.5 days, sweats and chills for 3 days, loss of appetite 3 days, weight loss 8lbs, Weakness, headaches, dehydration.
Moderna booster dose 0.25ml given to 5 year old instead of Pfizer kids.  Pt monitored for 1 hour without any ADRs.  Mom wants to seek medical attention.  Unsure of outcome
Increased heart rate. I received 9 alerts of having an increased heart rate between the hours of 3:58am and 7:43am.
This spontaneous report as received from a pharmacist refers to a female patient of currently 77 years old. No information about medical history, concurrent conditions were reported for the patient. The patient had unspecified reaction to penicillin on an unknown date. Approximately on an unknown date in 2011 (reported as 4 years ago) the patient was vaccinated with ZOSTAVAX 19400 Plaques forming units (Route unspecified) for vaccination. Concomitant therapies included SYNTHROID, TOPROL, ZOCOR and CELEXA. On an unknown date in July 2015 the patient experienced shingles and was treated with unspecified antivirals. The outcome of shingles was reported as recovered/resolved approximately on an unknown date in 2015. The patient sought medical attention. No product quality complaint was involved. Additional information has been requested.
I ached and had a headache, very bad body aches. It lasted till that Sunday. I called hospital number and they set me up with an NP and to get Covid tested.  Test came back negative.  I had Covid back in June, and Covid is much worse than the vaccine.
Information has been reported by a physician concerning a female patient who on 26-NOV-2014 received a dose of VARIVAX (Merck) (lot number not reported) instead of a dose of ZOSTAVAX. The physician stated that it is easy to mistake the VARIVAX (Merck) box for the ZOSTAVAX box since they are both the color green. No adverse effects were reported. The causality was not related. The outcome of wrong drug administered, product confusion and no adverse effect were unknown. No additional information was provided. Additional information  has been requested. This is one of several cases received from same reporter.
2 year old male vaccinated 2 days ago and today pt comes to be seen because left arm is swollen at the place of vaccination, erythematous and painful to touch. No temperature. Physical examination: Left upper arm with localized reaction but significant goes around the arm but not all the way. Warm. No streaks.
Stable and quiescent myesthenia gravis became active with right-sided weakness, pt. now unable to walk. 02/13/07-records received and reviewed for DOS 11/14-11/22/06 DC DX:Myasthenia gravis crisis Progressive weakness Respiratory distress Ileus Treated with IVIG, prednisone and mestinon. Reguired intubation and ventilator support. History of IgA deficiency. History of present illness; 24 hours after flu shot, right droopy eyelid and some left hand weakness. Has received flu shots for past 10 years without any problems. On 11/4 Seen in urgent care and treated with Mestinon. REsolved quickly. 11/6 seen in neurolgoist office with right upper extremity weakness, right ptosis and started on steroids. Weaknesses continued, unable to walk, diplopia. bilateral lower extremity weakness no complaint of headache, most recent seizure in September. PE:decreased grip strength on right, decreased strength of flexion and extension of biceps on right. Unable to move lower extremities bilaterally except for wiggling of toes. Slight abduction at hips bilaterally. Unable to produce any other movement.
A report has been received from a Health Professional concerning a 38 year old, female subject, who had been receiving Nasal FLUMIST QUADRIVALENT. FLUMIST QUADRIVALENT started on unknown date. It was reported that four patients were inadvertently administered expired FLUMIST QUADRIVALENT (Preferred Term: Expired drug administered) which started on 05-Dec-2013. The outcome of the event of inadvertently administered expired FLUMIST QUADRAVALENT to four patients is unknown. The report was considered to be non-serious.
Fever, chills, and headache. Chills (which likely included a fever) the night of the 11th. Had a slight fever all day on the 12th with a slight headache. Took Acetominaphen to help.
Allergies: Bee stings. PMH and Medications unknown to this writer. Immediately post vaccination pt had a syncopal event with flushing/sweating and dizziness. Vitals: @1800 BP 116/79, HR 65, RR 20 -- > @18:13 130/81, 79, 20 -- > @18:25 (sitting) 132/98, 86, 20 Pt stable and released from the vaccination site.
pain and swelling right arm pit.  Treated with warm compresses.  At this point it seems to be resolving.
Severe tingling in back arms, legs neck with pain in head and back with nasuea and fatigue. Went to ER and ambulatory car three time for these symptoms.
within two weeks, the tumors were half the original size and 9 months later there were no signs of HPV cancer; used GARDASIL 9 to treat HPV 16 cancer; The consumer reports that the patient also "had 3 additional doses injected directly into her tumors over an 8 month time period; This spontaneous report as received from an unspecified consumer refers to a female patient in her 90's. No information regarding patient's pertinent medical history, drug reactions or allergies and concomitant medications was reported.  On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) intramuscularly (exact dose, lot# and expiration date were not provided) for human papillomavirus (HPV) 16 cancer (considered as product use in unapproved indication). The consumer reports that on unspecified dates, the ,,patient was given two doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) intramuscularly 6 weeks apart". On an unknown dates, the patient also ,,had 3 additional doses injected directly into her tumors over an 8 month time period".   On an unspecified date, ,,within two weeks, the tumors were half the original size and 9 months later there were no signs of HPV cancer" and on an unspecified date, ,,2 years later, the patient had a follow up which showed zero histological signs of HPV" (considered as therapeutic product effective for unapproved indication). The outcome of the event was unknown.   The relatedness between the event of therapeutic product effective for unapproved indication and the suspect vaccine was not provided.
Anaphylactic reaction; Tachycardia/she felt her heart going fast; her throat starting to close/ Sensation of throat closure; Upper airway swelling/Increased use of accessory respiratory muscles; she could not breath/Difficulty breathing (without wheeze or stridor); Respiratory distress; her lips and tongue were big and it was getting worse; her lips and tongue were big and it was getting worse; Hoarse voice; Shock; Decreased level of consciousness; Generalized prickle sensation; Red and itchy eyes; Red and itchy eyes; Abdominal pain; The initial case was missing the following minimum criteria: adverse event (unspecified). Upon receipt of follow-up information on (17Mar2021), this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration administered on arm right on 25Feb2021 08:15 (Batch/Lot Number: EN6203) as SINGLE DOSE for COVID-19 immunization at the hospital.  Medical history included asthma. It was reported that the patient was allergic to NSAID, paracetamol (TYLENOL), pollen, cats and dogs; and insect bite/sting. She also had environmental allergies. It was also reported that her sister had breast cancer. Ongoing concomitant medications included spironolactone (SPIRONOLACTONE), vitamin C, cyanocobalamin (VITAMIN B12), calcium (CALCIUM), magnesium (MAGNESIUM), iron (IRON) and zinc (ZINC) all taken for unknown indications since unknown date. She had no other vaccines received around the time of COVID-19 vaccine vaccination. The patient was not pregnant (including at the time of vaccination). The patient received the first dose of PFIZER-BIONTECH COVID-19 VACCINE on 25Feb2021 at 08:15 AM.  Thirty minutes after the vaccination (at 08:45), she had an anaphylactic reaction as she felt her heart going fast and was noted to have tachycardia (as an organ involvement), had sensation of throat closure her throat starting to close. She had upper airway swelling with increased use of accessory respiratory muscles, respiratory distress as she could not breath (without wheeze or stridor). Her lips and tongue were big and it was getting worse. She also had the following organ involvements manifested by hoarse voice, shock, decreased level of consciousness, generalized prickle sensation, red and itchy eyes, and abdominal pain. She was administered with diphenhydramine (BENADRYL) IV. She was taken to ER and was also administered with famotidine 20 mg. The events were considered life threatening. The patient recovered from the events on unknown date in 2021.
Starting 06/03/2022 I developed head congestion, fatigue and muscle stiffness which lasted for about 3 days. Also I had a fever of 100 for about 4 days. Then, I had a mild cough and congestion for a few more days after that. I tested positive on 06/04/2022 with an at-home COVID-19 test and a PCR test. When I got the PCR test at urgent care, I asked for Paxlovid but due to my minor symptoms they said it was not necessary. I tested negative for COVID-19 on 06/14/2022.
Nausea 20 minutes after vaccine. Migraine headache 30 minutes after vaccine. Neck stiffness. Metallic taste in mouth and itching in back of throat approx 60 minutes after vaccine. BENADRYL 50 mg IM, TORADOL 60 mg IM and ZOFRAN 8 mg PO given to good effect. Observed approx 2 hours.
This spontaneous report has been received from the patient's father referring to a 13 year old female patient. The patient had no concomitant medication, pertinent medical history or drug reactions/allergies. On 11-OCT-2018, the patient was vaccinated with the first dose of GARDASIL 9 intramuscularly in the right arm for prophylaxis (batch/lot # reported as N0035957, expiration date reported as 10-OCT-2020; strength was not reported). On an unknown date in October 2018, the patient experienced unspecified viral symptoms after the injection and lost her voice within a week after being administered GARDASIL 9. The patient had no voice at all and could only whisper. The patient was given a week of prednisone (manufacturer unknown) and was seen by an Ear, Nose and Throat (ENT) physician. The patient had an endoscopy twice and the result of the first one was not reported. In November 2018 (reported as a week ago), the last one showed some redness in the throat but otherwise normal. The patient was going to see a voice specialist. At the time of the report, the outcome of the events was reported as not recovered. No causality assessment was provided.
Patient was administered a flu and pneumonia vaccination on Wednesday 11/20/02. Patient phoned HCP on 11/22/02 and stated she had fever, redness, and swelling at injection site and felt pain in glands under left arm and left side of neck. LVN at HCP referred patient to MD immediately.
Large local reaction measuring 20 cm at widest point - does not extend below the elbow - No systemic symptoms
This spontaneous report as received from a Medical Assistant refers to a patient of unknown age and gender. On 29-JAN-2014 the patient was vaccinated with M-M-R II (0.5 ml, lot # 671686/1874AA, expiration date 20-NOV-2013) subcutaneous. There was no concomitant medication reported. The Medical Assistant reported that the patient received an expired dose of M-M-R II on 29-JAN-2014. No adverse effect reported. Additional information has been requested.
Patient complains of head/nasal congestion, fever > 100 degrees, cold sweats.
Displayed excessive sleepiness and would not eat from 1-5:15pm, even though his prior feeding had been at 10AM.  Tried to wake him to feed, extremely fussy and seemed tired.  Slept until around 5:30pm.  Was very fussy, to the point that we had to give him Tylenol at 6:00pm, and were then able to feed him at 7:00pm.  Seemed overall more disinterested in things that otherwise had entertained him.  Crossing of eyes in the car ride home at 12:30pm, also later that evening.  The next day he was not as sleepy, though more so than previously; returned to a relatively normal cycle following this period.
red, swollen area under the vaccine site. area was about the size of a fist. Patient states the area is tender to touch.  no redness or swelling at injection site.  ibuprofen every 6 hours for next few days, until symptoms resolve
Pt received vaccine 12/31. She reported maculopapular rash on torso occurring on 1/1/11. She denies SOB or fever. She denies starting any new medications in recent history. She has had vaccine in the past w/out a reaction. Informed to contact PCP for follow up.
I was coughing for 10 months after TDAP shot. An X-ray showed patches on my lungs. They gave me antibiotics and I am not coughing as much now. (X-ray was 10 months later after vaccination).
1018 Janssen vaccination given to left deltoid per LPN.  1031 Pt reported "my head started hurting".  1033 Pt reported "my headache is getting is getting worse. It's starting to pound. I'm a little dizzy". No other symptoms reported at that time.  1035 Pt reported "my nose is starting to pour water and my headache is getting worse. I'm getting more dizzy". Respirations even/unlabored. No tightness of chest or throat. No swelling or rash.   1036 Benadryl 25mg (two tabs) given PO by FNP. Pt was able to swallow pills adequately. Reported "I always have trouble swallowing pills".   1037 Pt was assisted out of vehicle to chair beside her truck for better monitoring. BP 120/72, HR 96. Unable to pick up SaO2 on O2 sat monitor. She was speaking in full sentences. She reported "I need to throw up". Ice pack placed on back of neck. Stated that ice pack felt good.  1038 Trash can given for her to vomit in. Pt sitting up in chair. AAO x3.   1039 She reported "I don't feel right. My head is pounding. I feel like I can't catch my breath". EMS called immediately. Respirations were rapid, 30, mildly labored. Lungs CTA but breathing shallow.   1040 EpiPen auto-injector 0.3mg (1st dose) given IM left thigh by FNP. Pt was dry heaving and spitting out saliva in trash can. Reported "this is the worst headache of my life". Respirations mildly labored  1043 Pt developed dry cough, continued to have rapid respirations. Encouraged to slow breathing down and to breath deeply. Reported "still not feeling right". Pt became diaphoretic and pale.   1045 Pt's breathing became more labored and rapid with respirations 34. When asked if her throat was tight, she nodded to indicate yes.   1046 EpiPen auto-injector 0.3mg (2nd dose) given IM left thigh per FNP. Pt continued to breath rapidly, shallow. Pt unable to speak. When asked if she could breath, she shook her head no and began pounding on her chest with her hands. Ambulance arrived.  1049 Pt was assisted to ambulance gurney. Pt was able to assist with transfer. Reported "my head is hurting so bad". Respirations were less labored. Pt transferred to ambulance per EMS staff.
As soon as I woke up I began having very strong petit mal seizures and absence seizures. Which should have been controlled by my prescribed medications. Days later I had Two Generalized Grand mal seizures. I was already diagnosed with epilepsy before the vaccination, but my seizures have not been this bad in years. I got an MRI on 06/28/2015 and it came out normal so there should be no reason for the increased amount of seizures. The treatment is increasing my daily zonisimide intake.
Day 9 post-vaccine, employee developed a raised, red patch around injection site, approximately 3 inches wide by 5 inches long.  The area is not warm or painful.
Dizziness 10 min after shot and irregular high BP:159/115, 166/100, 153/117, 157/105, 133/91, 157/107 with normal HR (84-88) and 02 sat. No noted irregular heart rate. Patient already under care with PCP about high blood pressure and has planned FU.