chrisvoncsefalvay/vaers-outcomes huggingface dataset:
immunocompromised but did not get a third primary series; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (immunocompromised but did not get a third primary series) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025L20A and 031M20A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised. Concomitant products included APIXABAN (ELIQUIS), LEVOFLOXACIN, ATORVASTATIN, DILTIAZEM, MULTIVITAMIN [VITAMINS NOS] and COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) for an unknown indication.   On 17-Jan-2021, 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) (unknown route) dosage was changed to 1 dosage form. In August 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (immunocompromised but did not get a third primary series). In August 2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (immunocompromised but did not get a third primary series) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Jan-2022, SARS-CoV-2 antibody test: negative (Negative) less than Negative..         No treatment medication was provided. Patient stated that already had 2 primary doses and a booster and now is looking forward to get a 4th shot. Patient stated she is immunocompromised but did not get a third primary series.Patient blood work shows no antibodies.   Most recent FOLLOW-UP information incorporated above includes: On 28-Jan-2022: Followup received: Added lab data and updated narrative supplement.
My entire right arm, from my shoulder to my fingers, went numb. That stopped and then my arm was hurting. When I got up the next day, I had a horrible migraine and I felt like I had COVID again. The migraine continued and I went to the doctor on Thursday. I took Tylenol, but it only provided like 2 hours of relief. It didn't resolve the pain, but it did lessen it. My doctor told me to try an OTC med first, so I tried Extra Strength Excedrin and it went away. The first day that I didn't have a headache was exactly a week later. I'm not sure if they will return, but you're fine right now.
MODERATELY UNDER THE WEATHER; SOME CHILLS; FELT A LITTLE PAIN IN ARM AFTER IT WENT IN; TIRED; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced moderately under the weather, chills, pain in arm, and tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from moderately under the weather, chills, pain in arm, and tired. This report was non-serious.
LOCAL SWELLING, INDURATION, SCREAMED ALL NIGHT, SLEPT ONLY 3 HOURS
Delayed red rash appeared 8 days after injection. Rash was circular in nature, about the size of a baseball. It was warm and itchy. Rash has gotten larger, is no longer warm to the touch, continues to itch. Rash has been present for 6 days.
Patient requested the Moderna Booster. She had previously received the J&J as her first series.  Instead of giving her the 1/2 dose Moderna booster, we gave her a 1/2 dose of J&J.  I called CDC and they recommended to give the other 1/2 dose in the opposite arm. Patient tolerated both doses well.
Information has been received from a 80 year old female patient referring to herself. The patient's medical history included heart problem and diabetes. The patient was allergic to DEMEROL. On an unspecified date in 2010 (reported as "5 years ago") the patient was vaccinated with a dose of ZOSTAVAX (strength lot# and route unspecified: in the right arm). Concomitant therapies included oxycodone, morphine sulfate and lidocaine pain patches. On 04-JAN-2015 the patient got the shingles on her right breast, under her breast to her waist, under her arm and 5-6 inches from her shoulder to her waist. The patient sought medical attention and unspecified treatment was given for the event. Blood work was performed on an unspecified date in 2015 (result unspecified). The event was not improved and the outcome of the event was reported as not recovered/not resolved. The event was considered to be serious due to hospitalization or prolonged (detail information not provided). Additional information has been requested.
4 cm round edematous area at site, warm to touch, incision and drainage performed.
Myalgia, Fever, NauseaVomiting, also chills Narrative:
Patient received third dose of Covid vaccine. No treatment given, patient told to report adverse events to pharmacy. Patient reported tiredness, headache, joint pain, high blood sugars and chills
C/O h/a, vomiting & temp 104(oral) last night beginning about 7PM had ele temp most of night but better with no c/o this AM & temp down; Since midday c/o stomach pain, h/a, & temp over 104 & 1/2; Gave Panadol & APAP  returned to ER;
The patient received dose from vial beyond 30-day use by date.; The patient received dose from vial beyond 30-day use by date.; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The patient received dose from vial beyond 30-day use by date.) and PRODUCT STORAGE ERROR (The patient received dose from vial beyond 30-day use by date.) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (The patient received dose from vial beyond 30-day use by date.) and PRODUCT STORAGE ERROR (The patient received dose from vial beyond 30-day use by date.). On 11-Jun-2021, EXPIRED PRODUCT ADMINISTERED (The patient received dose from vial beyond 30-day use by date.) and PRODUCT STORAGE ERROR (The patient received dose from vial beyond 30-day use by date.) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.
Patient requested vaccination with Pfizer Covid-19 booster dose #2.  He was administered Moderna Covid-19 booster dose erroneously.  The error was noticed a few minutes after vaccination.  No adverse effects have occurred as of yet.  Patient is aware of error and will monitor for adverse effects.
RN attempted to administer Pfizer COVID-19 vaccine using a VanishPoint 25g 1mL needle (most likely from LOT G210308). Upon administration, vaccine "spilled" out from around the needle hub. RN confident no vaccine was actually administered, and proceeded to administer a complete dose using a separate syringe.
Pt recvd 3 doses of Engerix-B vax & was determined to be a non-responder; 10JAN92 pt recvd dose of Engerix-B;
Rash on back  this AM. HA last PM. Resolved. No fever. Tx Acyclovir 3tsp QID x 5 days.
HYPOXIA 12/9/2022 -- RECURRENCE OF SAME SYMPTOMS
This spontaneous case, initially received on 12-Aug-2016, was reported by a health professional and concerns a male patient. Weight: not provided; Height: not provided. Concomitant medication: Not reported. Administration of company suspect drug(s): On an unknown date "years ago", the patient received an unspecified flu vaccine. Dose regimen: Not reported, Route of administration: Not reported. Batch number: Not reported. No additional suspect drugs. Adverse reactions/events and outcomes: On an unknown date, the patient experienced Guillain Barre syndrome after receiving the vaccine (Medically Significant). The patient did not die. The outcome was reported as recovered. No additional information available. Reporter comments: The reporter could not rule out AFLURIA was given. Case correction 30-Nov-2016: company suspect drug corrected to influenza vaccine (INN).
Tremors in hands extended to whole body. Neurologist recommended Clonazepam but patient could not tolerate it.
Information has been received through a manufacturer pregnancy registry from a consumer concerning his 30 year old girlfriend with no allergies who on 20Sep04 was vaccinated with a dose of varicella virus vaccine live. There was no concomitant medication. It was noted that she was 4 weeks pregnant when she was vaccinated. No medical attention was sought. Follow up information from the pt indicated that the her LMP was 23Aug04 and she received varicella virus vaccine live on 23Sep04. She was pregnant up until 20Oct04 when she had a termination. She reported that she had only one other pregancy and had also terminated that one in the past (year not reported). The pt stated that she did not have an OB/GYN and she sought additional information. she reported that she did not really want to terminate her pregnancy but thought that was the only thing she could do. No further details were provided. Follow up 03/03/05: Information received indicated patient died and lot number for vaccine not provided.
myalgias, red bumps which later coaleced; became very pruritic & when seen there was much excoriation; occurred p/1st dose;
Pt was not supposed to receive vaccine due to age. Moderna vaccine is not approved for under 18 yrs but is available in clinical trials. We are not part of a clinical trial.
Adverse effect of other vaccines and biological substances, initial encounter on 2021-12-14.
Beginning of november pt developed blurry vision in both eyes - diagnosed with bilateral optic nerve edema. developed chest pain - diagnosed with PNA at another facility and treated with doxycycline. after this noticed numbness and weakness in extremities.  unable to ambulate 11/19/21. admitted on 11/21/21 - started on steroids. awaiting test results
shaking violently; Slept almost all day/She doesn't sleep during the day and these days she slept around the clock; not feeling terribly well; could barely stand or move; could barely stand or move; mental fog; extremely tired; had a fever, under a 100; had chills from the inside; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (shaking violently), SOMNOLENCE (Slept almost all day/She doesn't sleep during the day and these days she slept around the clock), MALAISE (not feeling terribly well), DYSSTASIA (could barely stand or move) and HYPOKINESIA (could barely stand or move) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012H21B, 024M20A and 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Heart disease, unspecified and Blood pressure. Concomitant products included LOSARTAN for Blood pressure, ASPIRIN [ACETYLSALICYLIC ACID] for Heart disease, unspecified, LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Dec-2021, the patient experienced TREMOR (shaking violently), SOMNOLENCE (Slept almost all day/She doesn't sleep during the day and these days she slept around the clock), MALAISE (not feeling terribly well), DYSSTASIA (could barely stand or move), HYPOKINESIA (could barely stand or move), FEELING ABNORMAL (mental fog), FATIGUE (extremely tired), PYREXIA (had a fever, under a 100) and CHILLS (had chills from the inside). On 13-Dec-2021, TREMOR (shaking violently), SOMNOLENCE (Slept almost all day/She doesn't sleep during the day and these days she slept around the clock), MALAISE (not feeling terribly well), DYSSTASIA (could barely stand or move), HYPOKINESIA (could barely stand or move), FEELING ABNORMAL (mental fog), FATIGUE (extremely tired), PYREXIA (had a fever, under a 100) and CHILLS (had chills from the inside) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Dec-2021, Blood pressure measurement: good category (normal) blood pressure was in the good category. On 09-Dec-2021, Body temperature: under a 100 (Inconclusive) she had a fever, under a 100. On an unknown date, Body temperature: lower than 98.6 (normal) she usually runs lower than 98.6.         About 2 hours after receiving the booster, the patient was not feeling terribly well. The patient was feeling better on 13-Dec-2021. The patient had doctor visit on 14-Dec-2021 (not known if the patient visited to the doctor). While she was not feeling well, she was not taking her medication.  No treatment information was provided by the reporter.
Severe dizziness - about 13-15 min after receiving vaccine. Laid down and one of the doctors took blood pressure. Top number was 139. Headache; low grade fever. Extreme fatigue. - All of those symptoms for about 3 days - pretty much bed bound. Took Tylenol and Ibuprofen.
About a week after vaccine, I could not focus for very long. I can not focus properly like I use to. I seems to have caused a brain fog. I talked to my doctor during my yearly annual and my doctor did not have any suggestion other than an adverse event. This is still continuing to this day. It does affect my job with not being able to focus. This has stopped me from getting the 4th dose.
c/o sudden onset nausea, cramping 15 hours post vaccine.  BP 120/74, T 99.5, P 72 regular, no clamminess, no paleness.  Advised contact physician if any breathing difficulty or new symptoms.
Possible reactivateds Epstein-Barr virus ill, not feeling great, described as malaise/low-grade fever and feeling off; A spontaneous report  was received from a consumer concerning a 51- year old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and developed possible reactivated Epstein-Barr virus, Ill, described a low-grade fever and feeling off (pyrexia) and is ill, not feeling great, described as malaise (malaise).  The patient's medical history mentioned history Epstein-Barr virus. Concomitant medications were not provided.  On 27 Feb 2021, the patient received their first of the two planned doses of mRNA-1273 (Batch number: 003A21A) in the left arm for the prophylaxis of COVID-19 infection.  Patient was ill stating that she started not feeling great, described as malaise, and feeling off and feeling a little feverish on 14 Mar 2021. A low-grade fever did not start until 16 Mar 2021. The symptoms were ongoing. She had already spoken with her primary care provider who did some tests, and it is possible that it could be reactivated Epstein-Barr virus.  The event, possible reactivated Epstein-Barr virus, was deemed as a medically significant event.   Treatment information not provided. Lab tests mention tests NOS done by HCP that could imply reactivated Epstein-Barr virus.  Action taken with respect to mRNA-1273 was not reported.  The outcome of the events, developed possible reactivated Epstein-Barr virus, Ill, described a low-grade fever and feeling off and is ill, not feeling great, described as malaise was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event of Reactivated Epstein Barr Virus Infection, a causal relationship cannot be excluded.
Developed shingles within 2.5 week of injection (haven't had shingles since I was 5), rash on chest (3 weeks after shot) Moderna COVID?19 Vaccine EUA
Information has been received from a physician and a certified medical assistant (C.M.A.) concerning an older adult woman in her 80's who during the week of 07-AUG-2006 was vaccinated with a dose of Varivax. It was reported that varicella-zoster virus vaccine live was ordered from the distributor but varicella virus vaccine live was delivered. The C.M.A. thought that the vaccine was to be used as the shingles vaccine. Unspecified medical attention was sought. The patient did not experience any adverse symptoms. The reporter also said that this was not a product confusion case. No product quality complaint was involved. Additional information has been requested.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Mar-2021 at 9:03 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 21-Mar-2021 at 9:03 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 49.93  Concomitant products were not provided.  On 21-Mar-2021, Excursion time was 09 AM,10 AM,11 AM, temp was 34, 32, 34, total doses given for the day was 94, condition of vaccine prior to vaccination was not frozen, vaccine was moved to fridge on 16-Mar-2021, vial was moved to clinic on 21-Mar-2021. 10 vial was moved to clinic. Vaccine BUD date was 15-Apr-2021.  Vial was stored on cooler 1, on 21-Mar-2021, Excursion duration At 9 AM: 34, 10 AM: 32, 11 AM: 34, 12 AM: 43, 1PM: 40, 2 PM : 40, 3 PM: 41, 4 PM: 41, 5 PM: 41.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a Fisherbrand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
Patient noticed large bump/swelling at the injection site with redness radiating distally in a pseudopod fashion. Infection not suspected on exam.
Started bleeding heavily bloody thick clots since day 1. I have been changing my tampon AND pad 2-3 times daily. I feel more fatigued and cannot exercise as well as I did before. More foggy sometimes blurry vision and edema and swelling in legs
trigeminal neuralgia treated with gabapentin  Left sided facial pain and lancinating left sided headache for one month
Pt received Hep A and Tdap in the right arm. Six days later, pt developed redness, warmth, pain and hard area at the point of Tdap and down to elbow, approx 20 cm. Pt used ice and ibuprofen. Pt seen on day 7 improved.
"Night tremor" type incident "weird cry" X 20 min.  Arms flailing, eye looking to left - unfocused.  T101.4  gaze deviating rapid eye blinking.  3/18/09 Received hospital medical records for 3/3-3/55/2009. FINAL DX: a seizure-like episode s/p vaccination Records reveal patient experienced seizure activity consisting of jerky movements of extremities x 1 day.  On exam, fever.  Tx w/IVF & antibiotics.  Neuro consult done & WNL.  Improved & d/c to home w/PCP f/u.
p/vax pt devel muscle spasms in rt arm by tricep-sx started right p/3rd anthrax vaxl
Patient had arm pain initially after vaccine which resolved. On 1/31, she developed severe headaches for 4 days.  On 2/2 ,she developed redness, warmth, tenderness, itching and pain at injection site.
Pain and swelling of the injection site, low grade fever, severe head and body aches, dizziness, chills, fatigue
patient who was given the first dose of MENACTRA at age 12. Parent is not sure if second dose was given at age 16. Patient is now 18 with no reported adverse event; Initial information received on 04-Aug-2022 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves a 18 years old female patient who was given the first dose of menactra at age 12. parent was not sure if second dose was given at age 16. patient is now 18 with no reported adverse event after receiving vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].  The patient's past medical history, medical treatment(s), concomitant medication, vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (strength, formulation, lot number and expiry date was unknown) via unknown route in unknown administration site for Immunization. Information for batch and expiry date was requested.  On an unknown date the patient developed a non-serious event of patient who was given the first dose of menactra at age 12. parent was not sure if second dose was given at age 16. patient was now 18 with no reported adverse event (product dose omission issue) (latency: unknown) following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE. The pharmacist states that they do not have records to show if a patient received their initial MENACTRA shots between 9-23 months of age. She knows that the patient received the Menactra at age 12 but she was not sure if she received a dose at 16. She asks if they should go ahead and give a MENACTRA dose at 18 for college, despite not knowing if the patient received the MENACTRA at age 16.  Action taken : not applicable.  Outcome: Unknown  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.
Besides what I already mentioned (Box 18), I only took her to the emergency room and she was diagnosed that she had an allergic reaction to the vaccine.  They prescribed her cream for the itching and some pills.
Patient states he fell. He thinks he has fallen every year for the past 3 years shortly after getting his flu shot.
I woke up and had a fever of 103. also had chills felt like I had covid. I couldn't walk on my right leg , my calve in my right leg was super red. I called my Doctor  and he told me to take Tylenol.  I felt better about 2 days later but my right calve was sore for a week.