chrisvoncsefalvay/vaers-outcomes huggingface dataset:
None- vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 041L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medication was reported.   This case was linked to MOD-2021-395985.
Rash and swelling on arm.   Took pictures and marked to see if changed over time.  Went away after about 24 hrs.
Large (8'' x 5'' x 1" ), elevated, swollen, firm, itchy, ununiform color (red, white) abdominal  urticaria on the injected side that started on the 7th day after the injection and is lasting for 5 days (not yet fully resolved)
Reported redness, headache, water eyes and nose, pain and site is warm to touch. Redness measured 10cm x 3 cm.
persistent/extreme irritable beginning approx 24 hrs p/vax; referred to ER @ 1130PM on 8APR94;
Sore arm, couldn't lift it.  Bled for 3 days, pain radiated down arm and into chest.  Continued all month.  Went to chiropractor on Dec. 23, no improvement, went to PCP on 12/26 and showed them where shot was given and told it was given too high and that she needed PT. Went to a different chiropractor on 12/27 and was somewhat better.  Pharmacy notified on 12/27.
suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in an unspecified number of patients who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. Reporter knew few people who after receiving Shingles vaccine, still got shingles. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation of shingles were not provided.
11/3 am - fatigue (extreme). 11/3 1pm - stomach ache (diarrhea x 3 hour) stomach pain lasted 3 d. 2 pm - body ache, muscle pain (severe), anxiety, migraine. 11/4 6 am - vomit, migraine HA from 2 pm 11/3 -> 2 pm 11/4 (24 hours) body aches, muscle pain continues through 11/8.
I have chronic pain in my left arm at the vaccine site. This pain started within 24 hours and has gotten worse with time. I have a mild constant headache in my arm, and when I do certain movements, the pain is so severe, it takes my breath away. The best way to describe it is like a labor contraction that I breathe through for anywhere from 30 seconds to a minute and the excruciating pain subsides until the next time. Just this past week, I was taking stairs down and I happen to step down hard with my left foot, and although I felt absolutely no pain in my foot or my leg, the pain piercing in my shoulder was so so severe, I had to stop and sit down and take deep breathes until it passed. This has been going on since June 18th, so over 4 months.  I have never experienced any kind of chronic pain in my life. This has been debilitating, I can't shower, wash my hair, get dressed, open a car door, drive, or sleep through the night without pain.
Chest pain. Feels similar to anxiety/stress chest pains.  Also, but not always at the same time as the chest pains, soreness of left arm mainly in shoulder area as well as neck pain and tightness. When I experience the shoulder and neck pain, I also sometimes feel like there is a lump in my throat and sometimes ear pain. This is all on the left side (left shoulder, left side of neck, feeling of lump on left side of throat, and ear pain in left ear).  Both of these have been almost daily in the last month.
1 week after receiving vaccine developed intermittent pins and needles sensation mostly in various places in legs, also some in arms. No obvious explanation for symptoms at present but in process of undergoing a medical evaluation with labs and potential neurology consult pending lab results.
VACCINE WAS REFROZEN; ADMINISTRATION OF REFROZEN VACCINE; This spontaneous report received from a health care professional concerned a 54 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821286, and expiry: 20-MAR-2022) dose was not reported, administered on 24-MAY-2021 for prophylactic vaccination. Age at time of vaccination 54 years old. No concomitant medications were reported.  On 24-MAY-2021, the patient experienced administration of refrozen vaccine. On an unspecified date, the patient experienced vaccine was refrozen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administration of refrozen vaccine and vaccine was refrozen was not reported. This report was non-serious.
1135 - pt reported throat feels difficult, no sob, no rash, no obvious swelling.   1136 - Benadryl 25mg po given - bp 152/95, p- 58, 02 - 97. 1147 - no change in s/s - 163/91, p-58, - o2 - 96. 1154 - reported mild numbness around nose - bp 177/117, p-59, 02 97 1204 - bp 154/81, p-60, o2 - 97 - no change in s/s
I have Moderna bivalent booster dose induced Dermatographia since 01/06/2023
This spontaneous report was received from a healthcare worker refers to an unknown number of patients with unknown demography. On an unknown date, the unknown number of patients was vaccinated with improperly stored MMR II (dose, route and frequency were not reported). No adverse effect reported. No further information was provided. This case is linked to the case 1404USA010658 and 1404USA010659 (same reporter link). Additional information has been requested.
Right deltoid, swelling, itching, redness and heat seen by provider; counseled re s/s infection/ s/s escalating Benadryl, Benadryl and ice.
Shortly after taking the 2nd Pfizer shot I became really dizzy and nauseous.  After being unable to recover within a few minutes and becoming increasingly unwell, I checked into the emergency room.
After a few days an upper arm rash at the injection site appeared along with some minor swelling and itching.  Size about 3 inches in diameter.  Now about 10 days after shot, rash is still there, perhaps darkening in color somewhat.  No material pain though.
Rebound symptoms worse than before or while taking the antiviral; congestion and more coughing; Rebound symptoms worse than before or while taking the antiviral; congestion and more coughing; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 44-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Apr2021 as dose 1, single (Lot number: ER8733), in left arm, on 24Apr2021 as dose 2, single (Lot number: WW0170), in left arm and on 11Jan2022 as dose 3 (booster), single (Lot number: FL3197) at the age of 43 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing); "anxiety" (unspecified if ongoing). Concomitant medication(s) included: SERTRALINE, start date: 01Jan2017. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 28May2022, outcome "not recovered" and all described as "Rebound symptoms worse than before or while taking the antiviral; congestion and more coughing". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results, notes: indication: Treatment of COVID-19. Therapeutic measures were taken as a result of covid-19, treated with Paxlovid, Treatment start date: 21May2022, Treatment stop date: 25May2022, Lot number: GA1189.  Follow-up attempts have been completed and no further information is expected.
On 3/1/16 (7 days after immunization) patient developed high fever and seizure -> dx with febrile seizure. Seen in office on 3/2/16 -> exam normal.
Flu like symptoms; fatigue; 1st dose:Date: 20May2021. 2nd dose: Date: 11Aug2021; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 23-year-old male patient received BNT162b2 (BNT162B2), on 11Aug2021 as dose 2, single (Lot number: EC3180) at the age of 22 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose: 01, Lot number: EW0171), administration date: 20May2021, when the patient was 22-year-old, for COVID-19 immunization, reaction(s): "Flu like symptoms", "Fatigue". The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 11Aug2021, outcome "unknown", described as "1st dose:Date: 20May2021. 2nd dose: Date: 11Aug2021"; INFLUENZA LIKE ILLNESS (non-serious), outcome "recovered", described as "Flu like symptoms"; FATIGUE (non-serious), outcome "recovered".  Additional information: Caller had 3 total doses of the Pfizer COVID-19 vaccine. Provided vaccination information from vaccination card. Just besides feeling general fatigue and flu like symptoms which caller stated everyone experiences. Caller confirmed he had general fatigue and flu like symptoms with the 1st and 2nd doses of the Pfizer COVID-19 vaccine.
This case was received from a consumer on 03 July 2008. SERIOUSNESS: OTHER - MEDICALLY SIGNIFICANT. A female patient reported that her infant child (gender not reported) had been exposed transplacentally to ADACEL (lot number C2688AA) on 09 November 2007. The reporter had a history of polycystic ovarian syndrome, seasonal allergies, and gestational diabetes. According to the reporter, she had experienced a persistent cough for three weeks at the beginning of her pregnancy, and had taken antibiotics before she knew she was pregnant. No culture had been taken. The infant child experienced transient tachypnea and infiltrates in the lower lobes. No additional information was provided. The information in this case pertains to the infant; information for the mother is captured in case number 2008-02177.
Approximately 3 red raised areas on outer aspects of let arm in elbow area.  Outer left leg red with one raised area on outer part of left leg at ankle area.  Stated "It is itching".      Her employer gave her 50 mg of Benadryl by mouth..  Monitored immediately.  v/s 130/90 , 90 16 o2Sat 99%.   at 12:55 pm.  1:10 pm 128/84, 82 o2 sat 100%.  all areas that were previously red at initial assessment were no longer present.
Vertigo and sudden onset complete neurosensorial hearing loss of right ear.  Sent to  ENT for evaluation and Transtympanic steroid injection. Confirmation by audiology of hearing loss. Onset of symptoms 3 days after vaccine.  Currently in treatment no improvement as of this date
fast heart beat that fluctuate from 57 to over 116; Weakness in chest; This is a spontaneous report from a contactable consumer (patient).A 68-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; Batch/Lot number: Not reported) via an unspecified route of administration, administered in Arm Left on 11Feb2021 at 04:00 as dose 1, single and patient received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; Batch/Lot number: EN6199) via an unspecified route of administration, administered in Arm Right on 10Mar2021 at 03:30 as dose 2, single for covid-19 immunization.Medical history included high blood pressure. Concomitant medication included lisinopril. The patient was allergies for iodine. Prior to vaccination, the patient did not had covid-19. Post vaccination, the patient has not tested for covid-19. There was no other vaccine in four weeks. On 12Feb2021 at 01:00 the patient experienced weakness in chest and fast heartbeat that fluctuate from 57 to over 116. It was reported that on 12Feb2021 the patient experienced really fast heartbeat that fluctuate from 57 to over 116. It goes up and down included with all of the other non-threatening side effects. Weakness in chest. she had it checked out, but she was still having the problems. She had the same problems the first time, but this time it was worst. The adverse event resulted in doctor or other healthcare Professional office/clinic visit, emergency room/department or urgent care. On an unspecified date the patient underwent lab tests which included heart rate: fluctuate from 57 to over 116 and results included that really fast /It goes up and down. The patient had not yet recovered from the events.    No follow-up attempts are possible. No further information is expected.
Information has been received from a health care professional concerning 6 patients, aged 3 to 7 years, who were vaccinated with varicella virus vaccine live. Subsequently, 2 patients from this lot developed breakthrough chicken pox with between 10-50 pox and a low grade fever fox less than 24 hours. The patients sought unspecified medical treatment. It was noted that all of the patients were vaccinated between 2 to 4 years of age. Additionally it was noted that 1 other patient developed a similar reaction after vaccination with varicella virus vaccine live. Additional information has been requested.
Mother of 18 month old stated her son woke the morning of December 7 2009 with a fine rash behind his knees.  The rash continued to spread to his entire legs, arms and the cheeks of his face. The rash developed large red bumps. No rash was noted on his trunk of his body and it does not itch. He ran a low grade fever of 99.7 F the day after the vaccination but now the fever has resolved. The child was seen by his pediatrician, diagnosed with a possible allergic reaction.  The child has had no new foods or medications. On December 15 the child was seen by a pediatric dermatologist and diagnosed with Gianotti-Crosti. Mom stated the dermatologist told her that the other causes are hepatitis B and Epstein Barr and ruled those out.  Hydrocortisone cream was prescribed but the deramtologist told mom the rash would have to run its course and takes about 6-8 weeks to resolve.
Woke up at 3am with a terrible headache and could not get back to sleep. Headache gone by 6am. I never get headaches.
DTAP-HIB-IPV, PCV 13, ROTAVIRUS - fussy ever since, decrease appetite, no fever, painful screaming crying. At office visit 5/27 consolable with mom holding. Dr. reeducated re TYLENOL use & increase dose to 120 mg.
I was having symptoms like I had COVID. Nausea, vomiting, headache, sore throat, diarrhea, stomach ache, fever and body ache. I felt like I got hit by a train. I'm still suffering from these symptoms till today. They lasted for 3 weeks. I went to the ER several times during each week.
About 2 hours after the vaccination, starting low on right side of neck, felt a mild burning sensation move up into my right side of face.  Swelling on right side was noticeable for two days.  Mild numbness also occurred that went away  as swelling subsided.  However on 3/3/21 I am noticing numbness in upper lip and jaw... also mild.
Pt. began to describe a feeling of swelling in her left arm and left side of her face.  EMS did not note any swelling or neurological deficits.  Pt. was evaluated and refused transport. Completed an AMA.
patient developed 3 - 4 days later rash and swelling of face, eyelids and neck.  lasted 2 weeks 4 hours after the second vaccine, patient again developed face, eyelid swelling and then developed severe rash on legs, arms, back, buttocks that lasted until mid August, now gradually fading
A spontaneous report has been received from a Health Professional concerning a patient of unknown age and gender, who had been receiving Nasal FLUMIST (INTRANASAL). FLUMIST (INTRANASAL) started during Oct-2014. PATIENT RECEIVED FLUMIST AFTER VACCINE TAKEN OUTDOORS ON EXCURSIONS, EXPOSED TO A WIDE RANGE OF TEMPERATURE CHANGE during Oct-2014. The outcome of the event of 5 PATIENTS RECEIVED FLUMIST AFTER VACCINE TAKEN OUTDOORS ON EXCURSIONS, EXPOSED TO A WIDE RANGE OF TEMPERATURE CHANGE is unknown. The report was considered to be non-serious by the company physician.
Patient was mistakenly given a 0.25ml dose instead of the indicated 0.5ml dose. Patient returned to the pharmacy the next day to receive the remainder of the dose.
Large area of redness and swelling 24-48 hours after immunization. No treatment. Small lump palpable.
Constant. Severe itching all over body, chronic hives, dermatographia, heartburn, stuck pill feeling in throat, joint pain,  fatigue, difficultly staying focused.
No other information provided.  No additional AEs or PQC reported.; Caller reported expired dose of MMR II was administered.; This spontaneous report has been received from  a certified medical assistant (CMA), referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history and concurrent condition was not provided. Concomitant therapy included sterile diluent (Lot Number: W000454 with expiration date: 25-JUL-2024).   On 20-SEP-2023, the patient was vaccinated with expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant human albumin) (M-M-R II) (lot # W011885 with expiration date: 04-SEP-2023, 0.5 milliliter, strength unknown), intramuscularly in the left thigh for prophylaxis (expired product administered). No other information provided. No additional adverse events (AEs) or product quality complaint reported.
28DEC2020 (lot number 026L20A, expiration date unknown), and 17FEB2021; bad vertigo/sitting there and feeling the room spin; doing downward dog and getting dizzy; bending down, standing up, and getting dizzy; This spontaneous case was reported by a nurse and describes the occurrence of VERTIGO (bad vertigo/sitting there and feeling the room spin), DIZZINESS (doing downward dog and getting dizzy), DIZZINESS POSTURAL (bending down, standing up, and getting dizzy) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (28DEC2020 (lot number 026L20A, expiration date unknown), and 17FEB2021) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 026L20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (suspects she still had antibodies at the time of vaccination attributing to her symptoms) in December 2019.   On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Feb-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (28DEC2020 (lot number 026L20A, expiration date unknown), and 17FEB2021). In 2021, the patient experienced VERTIGO (bad vertigo/sitting there and feeling the room spin), DIZZINESS (doing downward dog and getting dizzy) and DIZZINESS POSTURAL (bending down, standing up, and getting dizzy). On 17-Feb-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (28DEC2020 (lot number 026L20A, expiration date unknown), and 17FEB2021) had resolved. At the time of the report, VERTIGO (bad vertigo/sitting there and feeling the room spin), DIZZINESS (doing downward dog and getting dizzy) and DIZZINESS POSTURAL (bending down, standing up, and getting dizzy) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter.  Patient treatment information include ears cleaned, and an Epley Maneuver performed. They said they had seen similar symptoms in other patients before. She has not tried any additional treatments.  Patient has a history of covid-19 diagnosed in December 2019, and suspects she still had antibodies at the time of vaccination attributing to her symptoms.   This case was linked to MOD-2021-353425 (Patient Link).
Influenza, Hep A, Menactra and Varicella administered. Patient began to experience hives, hitching, SOB and increased HR about 20 min after administration - given Epinephrine 0.5 ml IM to (L) deltoid.
Intense headache for 12 hours with 100 degree fever, muscle aches and nausea
Severe Headache severe body aches very dizzy fatigue extreme skin sensitivity GI issues (lasted 2-3 days)  With first 2 shots also had reactions- both lasting 1 1/2 weeks ea.   (pretty much same  reactions but had fever with 2nd shot as well) Had Moderna all 3 shots
Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     Concurrent medical conditions included Autoimmune disorder (MAST cells disorder and Tryptase disorder) and Allergy (She states she has a lot of allergies).    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). The patient was treated with NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: abnormal (abnormal) because her disorders can cause leukemia.         Patient height was 5 feet 3 inches.  Patient with immune disorders received booster dose instead of third dose. First, second and booster where received in the recommended time frame. Patient wants to know if she can receive another booster shot for immunocompromised people, she heard there was another booster shot coming in march, and wants to know if she qualifies.   She has not yet spoke to her physician about this enquiry.   No concomitant medication were reported.   She states she has a lot of allergies. She can provide more information if contacted by safety team.  Patient was not tested positive.   No other vaccines given within 1 month prior to Moderna COVID-19 vaccine.   This case was linked to MOD-2022-496387, MOD-2022-496388 (Patient Link).
Information has been received from a nurse referring to unspecified patients of unknown age and gender. The patients' concurrent condition and medical history were not reported. The concomitant therapy included sterile diluent (manufacturer unknown). On unknown dates, the patients administered improperly stored doses of VAQTA (dose, frequency, route and expiration were unknown, lot #M039202, lot#N005274) for prophylaxis. The temperature excursion was at 9 Celsius Degree to 25 Celsius Degree for 4.5 hours. There was no previous temperature excursion. Data logger involved. No adverse effects were reported in any patients. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA006062: US-009507513-1709USA006065: US-009507513-1708USA010866: US-009507513-1709USA006064.