chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Arthritic pains; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Arthritic pains) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.   Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.  No Medical History information was reported.  On 22-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced ARTHRALGIA (Arthritic pains). At the time of the report, ARTHRALGIA (Arthritic pains) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medication information was reported. No treatment medication information was reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
patient came to Med opts one at 1:05 with complaints of being dizzy and slightly nausea. she looked blush in the face and sweaty. husband said she suffers from panic attacks and anxiety. had similar symptoms after she got home from her first dose of pfizer. patient had a hard time keeping her eyes open because she took a klonopin before arriving. patient was given water and an ice pack for the back of her neck. we slowly moved her from a supine position to a sitting position until she felt well enough to move to the wheelchair. patient was here approximately  35 minutes until she felt well enough to be moved to her vehicle. husband drove her home.
Patient attended a vaccine administration event with his mother on 19MAR2021. Patient completed our clinic's registration even though it was only offered to those 18 years and older. The patient made it to the vaccination station without the staff noticing that he was 17 years old. It was not until the patient was being registered into our clinic's EMR that the staff was made aware of his age. The patient's mother was contacted and stated there were no adverse reactions and that he was in school.
This spontaneous report was received from the registered nurse refers to multiple unspecified patients of unknown age and unknown gender. No medical history and concurrent conditions of the patients were reported. On an unknown date, multiple unspecified patients were administered improperly stored ROTATEQ (L022446 and expiry date 14-FEB-2017, L008577, expiry date: 02-DEC-2016) (dose, route, therapy type not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
I believe it caused a high calcium level after receiving the vaccine.  My calcium went up to 11.0 on Dec. 19, 2022 and my PTH went up to. 96.   In February I was diagonsed with hyperparathyroidism. Never had a high calciuym before and now my calcium is backto normal on two occasions.
Swelling at injection site, 2" diameter red raise spot. Burning and soreness.
Patient is experiencing muscle pain in the left deltoid where she received the vaccine, about 1 month after receiving the vaccine.
His left shoulder is sore but not swollen during palpation and he didn?t lose his strength and/or sensibility.
Sore throat started night of having vaccinated treated it like a cold. No other signs of cold or symptoms a week later. Allergist concluded since lab results were negative for staph or bacterial-treat patient for herpes viral with acyclovir. Tx was successful.
After getting my COVID-19 vaccine about 14 days later I started having hives and was itchy. It was so bad that that if you touched my skin it would leave a mark as if you could draw on me. Anything touching me would leave this raised rash on my skin as well. I reached out to my dermatologist and did a telehealth visit with them on November 22nd, 2021. They diagnosed me with Acute Urticaria and Dermographism. I was told to try a combination of ALLEGRA, ZYRTEC, and BENADRYL. I try to avoid BENADRYL and it did not work but I was given a prescription for triamcinolone acetonide cream. The cream made the rash manageable, but it did not resolve or eliminate the rash. The rash lasted for about 6 to 8 weeks but for that duration anything that contacted my skin would create that raised rash and irritation and if I scratched it created heat as well. I have discovered this time around that my skin prefers a cold shower and that also helps relieve some of the symptoms. This also occurred after getting my Moderna vaccine which is why I got Pfizer with the hope that it would be avoided this time around, however it seems I am experiencing the same thing and this is ongoing at this point. I am seeing a Dermatologist in July 2023 who is specializing in dermatological issues after having a COVID-19 vaccine.
Moderna COVID-19 Vaccine EUA  Pt received Moderna COVID vaccine 2/15/21 (per pt, was 2/8/21 but shows 2/15/21). On 2/25/21 patient presented to ED with a complaint of generalized weekness for about 1 week, reporting it was worse that day. Pt reported diarrhea on Sunday 2/21 but none at visit. Denies fever, chills, chest pain, shortness of breath, nausea, vomiting, abdominal pain, vision changes, headache, sore throat, cough, diarrhea since Sunday, constipation, dysuria, hematuria, altered mental status. Low grade fever of 100 F, BP 155/65. Pt was tested for COVID, resulted in positive, and sent home with instructions for care.  2/26: Pt was contacted regarding starting monoclonal antibody bamlanivimab infusion.
Patient came to ER for 2nd injection of Hep B series on 3/10/09.  The next am she noticed weakness in right hand upon awakening. Patient was seen by Dr. in clinic for further evaluation. Follow-up call on 3/13/09 S&S resolved.
patient's anaphylactic reaction persisted longer than expected; This is a spontaneous report from a contactable pharmacist.  A 45-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in Dec2020 at a single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported.  The patient's anaphylactic reaction persisted longer than expected in Dec2020.  The outcome of the event was unknown.    The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.; Sender's Comments: The causal relationship between BNT162B2 and the event anaphylactic reaction cannot be excluded as the information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
This spontaneous report was received from a Licensed Practical Nurse referring to an unspecified number of patients of unknown age and gender. No concurrent or historical conditions were reported. On unknown dates, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB (lot # K025004, expiration date 22-JUL-2017) and (lot # L002867, expiration date 11-NOV-2017), doses, routes and anatomical locations were not provided. No concomitant medications were reported. No adverse effects reported. No product quality complaint was involved. This is one of several reports received from the same source. Additional information has been requested.
9:30 weak and dizzy no fever productive cough injection site warm  ,sore,no reddness
This spontaneous report as received from a other health professional refers to a patient of unknown age. On 17-JUL-2017 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot number M042324 expiration date: 10-JUN-2018, lot number: M044564 expiration date: 22-OCT-2018, lot number: N001007 expiration date: 09-SEP-2018) for prophylaxis (digital data logger). No adverse effects reported. Sender's Comments: US-009507513-1708USA002800.
REDNESS AND SWELLING AT VACCINATION SITE L DELTOID. AREA HOT TO TOUCH AND TENDER TO TOUCH. MOM STATES, SWELLING INCREASING.
R arm at the site of the varicella vaccination-warm, pink, swollen and itchy.
Post vax the patient developed severe back pain, weakness and was tired. These symptoms progressed as the day went on accompanied by chills and a headache. The patient was advised to seek medical attention.
Began having chills, achy joints, shoulder (left) and neck pain (left arm received vaccine) around 2200 on eve of vaccine.  Began running fever of 100.2 by 0200 on 3/17.  Joint pain became worse by 1am with waves of severe pain in joints in knee, shoulder and neck.  By 5am of 3/17/09 having pressure in base of skull/neck causing headache, dizziness and nausea.  This much worse when standing, pressure still there when lying down.  This continued through this day.  Next day 3/18/09 still having pressure in neck/base of skull with headache and low grade temp (99.4). Joints still achy, but only rare episode of more intense joint pain.  This continues today on 3/19/09.
Injection very painful originally, pain at site becoming more severe over course of day, by 3:30 pm pain unbearable, felt like I ran into a brick wall, unable to lift my left arm, had to support it at elbow with right hand.  thick swelling at injection site,  chills and fever from 100 degrees to 101 degrees .  I was in bed by 7:30 pm, fitful sleep for most of night. By 6:00 am next morning, no chills, no fever, soreness still in arm, but no longer extreme pain.  Soreness lasted for another day or two.
EMS reports pt had syncopal episode after vaccinated while waiting in observation area. No LOC. Refused transport to ER.
administered an expired dose; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 21-year-old female patient who received Men B NVS (Bexsero) (batch number unknown, expiry date January 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 22nd February 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 22nd February 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device and unknown after starting Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. Medical Assistant inquired about re-administration of Bexsero They inadvertently administered an expired Bexsero to the patient on the day before reporting, which led to expired vaccine used. The reporter declined follow-up from safety.
Significant swelling of the lateral left thigh, with limping, minor discomfort, mild erythema, and taut skin.
Left-sided facial numbness within 15 minutes of receiving 2nd vaccine dose. Progressed to headache and nerve pain in legs within 30 days. Symptoms worse at night and worse on left side leading to insomnia. Evaluated by PCP and neurologist. Blood work, CT scan, MRI are all clear. Nerve pain and insomnia have improved. Continue to experience periodic left-sided facial numbness with slow-opening left eye after sleep as well as muscle soreness in legs in evenings 75 days post-vaccine.
Patient got the 2nd dose only 21 days apart rather than 28 days by oversite No side effects reported yet.
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored doses of GARDASIL 9 (strength, dose, frequency, route of administration were not reported) lot # N021571 with an expiration date on 29-APR-2020 for prophylaxis. No adverse effects were reported. The vaccines underwent temperature excursion of 32 to 35 degrees Fahrenheit (F) (34F) for 102 hours and 47 to 77 degrees Fahrenheit (F) (47F) for 18 hours. No previous temperature excursion was reported. A digital data logger was involved. This is one from a several reports from the same reporter. Sender's Comments: US-009507513-1811USA005707: US-009507513-1811USA005706:US-009507513-1811USA005709: US-009507513-1811USA005705: US-009507513-1811USA005708.
Facial palsy reaction; A spontaneous report was received from a consumer (patients wife) concerning an male patient of unknown age who experienced the event facial paralysis.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On unknown date, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) via unknown route at unknown anatomical location for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event facial palsy. Information about treatment was not provided.   Action taken with mRNA-1273 in response to the event was unknown.  The outcome of the event facial palsy was unknown. ; Reporter's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
Because of prior reaction to Moderna 2nd dose, my physician put me on an allergic protocol to take prior and during the inoculation procedure for my booster injection.  I was taking benadryl twice daily 2 days prior to inoculation, also my usual Zyrtec and Pepcid AC that I take for acid reflux. Approx 6 and a half hours after receiving the booster (4:30 pm.), I started having allergic throat reaction (scratchy throat, feeling of swollen throat like a lump in my throat, voice raspiness, etc.)  Kept taking Benadryl every 4 hrs. By 7:00 pm, throat symptoms getting worse so called an ambulance and was taken by ambulance to the ER.  My vital signs were monitored and after about an hour the attending physician determined my symptoms had subsided enough to discharge me.  I then went home.  My throat never felt that it had returned to normal, so I had to contiunue with the prescribed Benadryl for next four days taken three times a day while continuing with the prescribed Prednisone (for this episode only) for the prescribed ten days, along with my regular Zyrtec and Pepcid AC.
5/24/04- received anthrax #1 (given alone) on left upper arm- no anaphylaxis sxs. 5/25/04- developed "extremely" pruritic rashes (sudden) on the left side of the body- started from the inoculation site to left axillary region to left shoulder, then to left hand- unable to sleep d/t pruritus- no other systemic complaints. 5/26/04- seen by healthcare practitioner- given steroid po x3ds- "better" but rashes did not resolve completely. 6/4/03- deployed - noticed lesions reappearing for "about three days" then disappearing without any intervention- lesions completely resolved 2 wks after receiving the vaccine.
This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired doses administered) and PRODUCT STORAGE ERROR (Initially vaccine was stored in fridge on 07-Feb-2022and was administered on 08-APR-2022 after more than 30 days) in a 71-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 083J21A) for COVID-19 vaccination. No Medical History information was reported. On 08-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired doses administered). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Initially vaccine was stored in fridge on 07-Feb-2022and was administered on 08-APR-2022 after more than 30 days). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired doses administered) and PRODUCT STORAGE ERROR (Initially vaccine was stored in fridge on 07-Feb-2022and was administered on 08-APR-2022 after more than 30 days) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. It was reported that, the patient received total 4 doses and this was second booster dose. On 07-Feb-2022, the vials were initially stored in the refrigerator. The vial did not undergo any temperature excursions. Treatment information was not provided. This case was linked to MOD-2022-584673 (Patient Link).
Influenza vaccine administered on 10/30/08. Pt. reports on 10/31/08 had burning sensation in right arm that morning. Reports she then developed itching on both arms, lower abdomen along beltline and lower legs.  She reports  taking Benadryl on Sunday evening, 11/02/08 to help relieve the itching.  Client presented to Health Department with raised, reddened rash with some scabbing to areas that she had scratched.  Rash was present on both arms, few spots on lower abdomen and few spots on lower legs below the knees.  Instructed pt. to follow up with physician.  She reported she had to work and was unsure if she would be able to follow up.  Spoke with pt. on 11/05/08 and she reported she did not follow up and rash was no longer itching and was beginning to clear up.
This spontaneous report a received from a registered nurse refers to a patient of unknown age and gender. On 05-OCT-2009, the patient was vaccinated with the first 0.5 ml dose of (Oka/Merck) VARIVAX (lot # not reported) subcutaneously, on 13-JAN-2014, the patient received the second 0.5 ml dose of (Oka/Merck) VARIVAX (lot # not reported) subcutaneously and on 23-SEP-2014 the patient received a third 0.5 ml dose of (Oka/Merck) VARIVAX (lot # not reported) subcutaneously. No adverse effects were reported. Additional information has been requested.
This spontaneous report was received from a licensed practical nurse referring to a patient of unknown age and gender. There was no concomitant medication. Information about concurrent conditions and medical history was not provided. On 25-APR-2017 at 10:00 am, the last recorded temperature of the vaccines was 4 Celsius degree. On the same day at unspecified time, the ROTATEQ were discovered out of temperature range (refrigerator temperature was 12.7 Celsius degree). The vaccines were not moved to a working refrigerator post the event. It was also reported that the vaccines experienced a temperature excursion during 1 hour 17 minutes. No previous temperature excursion was reported. A data logger issue was involved. On 17-MAY-2017, the patient was vaccinated with improperly stored doses of ROTATEQ (lot number M039067 with expiration date of 18-APR-2018; strength and dose were unknown; location was also reported as "2", dose number was also reported as "0"; Vaccines for Children Program (VFC) stock) orally for prophylaxis. The nurse sated that they would monitor every 30 minutes to insure temperature with range. It was confirmed the vaccines were OK to use. There was no adverse event reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1704USA014144:
there was not an adverse reaction of any kind but am reporting that this dose was given from a vial stored beyond the recommended 31 days in the refrigerator
Pt reports lymphadenitis on axillae and neck, left side only, and a headache. No injection site reaction.
Received a dose of the Moderna COVID-19 vaccine at the age of 16; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Received a dose of the Moderna COVID-19 vaccine at the age of 16) in a 16-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042B21A) for COVID-19 vaccination.     Concomitant products included LORATADINE from 04-Oct-2017 to an unknown date and MONTELUKAST from 04-Oct-2017 to an unknown date for Allergic rhinitis.    On 26-Jun-2021 at 4:16 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jun-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Received a dose of the Moderna COVID-19 vaccine at the age of 16). On 26-Jun-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Received a dose of the Moderna COVID-19 vaccine at the age of 16) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient did not seek any medical care. No treatment medication were reported. It require clarification and confirmation if adverse events occurred after the vaccine was administered.   Most recent FOLLOW-UP information incorporated above includes: On 04-Aug-2021: significant follow up received on 04-Aug-2021 in which new event updated.
MENQUADFI given too early after first dose of MENACTRA on accident, with no reported adverse event; received an extra dose , with no reported AE; Initial information received on 07-Sep-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 11 years old and unknown gender patient who was given menquadfi too early after first dose of menactra on accident, with no reported adverse event and received an extra dose with no reported ae after receiving vaccine MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE [MENQUADFI].  The patient's past vaccination(s) included MENACTRA on 22-MAR-2022 with first dose. The patient's past medical history, medical treatment(s) and family history were not provided.   On 05-Aug-2022, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE lot U7294AC and expiration date: 23-May-2024 at a dose of 0.5ml once via intramuscular route in the left deltoid as prophylactic vaccination.  On 05-Aug-2022(latency: same day), the patient  was given menquadfi  too early after first dose of menactra on accident, with no reported adverse event (inappropriate schedule of product administration). It was also reported that the patient has received an extra dose with no reported ae (extra dose administered).   Action taken :not applicable.  It was not reported if the patient received a corrective treatment for the events.   Outcome: unknown for both events    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.