chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Diverticulitis; Shingles; Pain wraps around to my back; Skin feels burned; Feels like electrical shocks inside; This case was reported by a consumer via interactive digital media and described the occurrence of diverticulitis in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 25th August 2022, the patient received the 1st dose of Shingles vaccine. On an unknown date, less than 2 months after receiving Shingles vaccine, the patient experienced diverticulitis (serious criteria GSK medically significant), shingles, back pain, burning sensation skin and electric shock sensation. On an unknown date, the outcome of the diverticulitis, shingles, back pain, burning sensation skin and electric shock sensation were not recovered/not resolved.   It was unknown if the reporter considered the diverticulitis, shingles, back pain, burning sensation skin and electric shock sensation to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 05-OCT-2022 Reporter's Comments: This case was reported by a patient via interactive digital media. The patient had it right now at the time of reporting. The patient had one shingles vaccine on 25th August 2022.  The patient having his/her second dose in November 2022.  The patient had a CT scan and had diverticulitis in addition to shingles on his/her side.  The pain wraps around to his/her back.  The patient did not had a rash but his/her skin felt burned and it feels like electrical shocks inside and it was terrible. Follow-up would not possible as no contact details were available.
Patient described redness and pain along with tingling starting from injection site, which then spread down to elbow and shoulder blade. It initially started at about 8PM on the day of vaccination and then continued, reported after 2 days and was still present. Patient tried taking both benadryl 25 mg and naproxen 220 mg neither provided relief from burning or pain. Informed patient to continue trying benadryl as tolerated and tylenol or ibuprofen for pain.
According to the ER report - woke up with itchiness about inj site. Mild erythema & warmth.
pt recv vax 24JAN97 & between 24 & 25JAN97 a 9x12 area of skin (below the deltoid to the elbow) became red, swollen, & warm to touch;tx w/APAP & is to see an MD on the day of this report;
Baby cried inconsolably for a long period of time (30 min). She also had a fever of 101.  This was not in her nature to cry so much and be so irritable.  She struggled the rest of the night.
A spontaneous non-serious report of inadvertently administered FLUMIST to a 55 year old male has been received from a nurse.  Medical history and concomitant medications were not reported.  On 05-Dec-2008, the patient received FLUMIST.  Shortly after the nurse administered FLUMIST, she discovered that the drug was not approved for the patient's age group.  The patient did not experience any apparent changes in medical/health status.  There was no adverse event associated with this medication error, therefore;  treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.
Nine days subsequent to receiving one dose of rubella virus vaccine live (second generation), a middle aged female pt developed a rash, cough, runny nose, swollen lymph nodes and achy knees. The pt sought out unknown medical attention. Additional information has been requested.
Extreme Chills, Nausea, Severe Headache, Stiff neck and shoulders.  Symptoms were from 3AM until Noon  (9 hrs)
headache, fever, injection site pain  starting same evening as injection.  Connoted fever with tylenol or Ibuprofen until Monday evening (post 48 hrs).  First evening reported right side of chest hurting.  Random sharp pains throughout body on Sunday and Monday.  Fatigue.
A few hours after Shingrix vaccine (2nd dose) = Started having Fever 100.4, Chills, Cough, Extreme body aches, Sore left arm, Extreme weakness. These side effects continued for the next 4 days.  On 12/31/20 in the AM, started hurting when taking a  deep breath in right rear lung area. This continued. Went to Urgent Care. A Covid test and Flu test was done = Negative. A chest X-Ray showed clear but Dr. thought I might have Pleurisy, since I've had Pleurisy many times in the past. I was given an injection of steroid, Dexasone.
Migraines got worst; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (Migraines got worst) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Migraine.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced MIGRAINE (Migraines got worst). At the time of the report, MIGRAINE (Migraines got worst) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medications reported by investigator o No treatment medications provided by the reporter.
Swollen right upper arm, tense, red, warm to touch, swollen at injection site, within 24 hours after vaccination.  Patient returned to office on 05/21/2003:  Vaccine information reviewed with parent form # 3177 rw 07/30/2001.  Advised heat and urice at site and motrin for pain and swelling.  Patient to return to office for follow up in 1 week.
Pt describes fever, achiness, redness @ injection site lasting for 3 days. Has had influenza vaccine previously w/o any problems. She describes these s.e's as being severe.
Mother calls health department on 05/24/2019 to report that patient'r left arm is red and swollen.  Swelling extends up the left arm and into left side of her neck.  Mother reports that she has had a fever off and on since vaccination also.  Patient also has pain in left arm.
This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 55-year-old male patient who received ENGERIX B adult (batch number 24JP3, expiry date 10th July 2017). On 2nd April 2016, the patient received ENGERIX B adult 1 ml. On 2nd April 2016, less than a day after receiving ENGERIX B adult, the patient experienced fever. The patient was treated with ADVIL. On an unknown date, the outcome of the fever was not recovered/not resolved. It was unknown if the reporter considered the fever to be related to ENGERIX B adult. Additional details provided were as follows: The patient had a mild fever and was not recovered till the time of reporting. No further information was provided.
190 patients (9 different lot numbers) received a vaccine past the beyond used by date; No Adverse Event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No Adverse Event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date).    No concomitant medicine were reported. No treatment medicine were reported. This case was for 57th out of 189 patients reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-704335 (Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704335:Master case
Beginning on the evening of my second dose, I had a fever of 103 degrees that lasted for approximately 24 hours.  Additionally, my menstrual cycle began that day, which was expected.  However, it lasted for 9 days, which was unusually long.  Then 13 days after it ended, I got my period again.  Since that time, I have sometimes had 2 periods per month, with unusual amounts of bleeding.  I was recently diagnosed as newly anemic and multiple fibroids were found in my uterus.  I previously had one fibroid removed 10 years ago.  I realize the timing may be unusually coincidental, but am reporting in case there is an increase of fibroids with others following vaccination.
Information has been received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history and drug allergies were not reported. On 22-OCT-2015 the patient was inadvertently vaccinated with one dose of Liquid PEDVAXHIB (lot # L014429 with expiration date of 15-MAR-2018, dose, strength and route unknown) and one dose of another dose PENTACEL. No adverse effects reported. Additional information has been requested.
11/09 &PM itchy, hives, upper torso, arms, neck, itchy throat Benadryl at 12AM. 11/10: 6 PM hives, itchy face, upper back, head Benadryl x2, then again x1. 11/11 no hives, took Benadryl 50 mg. prophy. and Zyrtec 10 mg.
This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (it's been 46 days since the first injection) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 19-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (it's been 46 days since the first injection). At the time of the report, PRODUCT DOSE OMISSION ISSUE (it's been 46 days since the first injection) had resolved. 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. No concomitant medications reported. Treatment information not reported.
Underage before the approval for Pfizer vaccine . Suspected falsification of DOB ? unable to contact guardian
I have experienced: ? pain/discomfort in my joints (knees, elbows, shoulders, fingers.)   - I am still currently experiencing pain/discomfort in my joints.  ? extreme fatigue  - The extreme fatigue lasted roughly 4 days, I was lucky enough to be able to take off work and therefore had the ability to sleep for literally 74 hours straight aside from waking up to use the restroom.  ? light sensitivity followed by a migraine  - The light sensitivity and migraine were my immediate reaction following the vaccine and lasted until the morning after my initial dose.   ? numbness and a tingling sensation in both of my arms and hands.   - I am still currently experiencing numbness and tingling in my arms and hands.  ? nausea   - I had nausea the day after my vaccination and it lasted throughout the day, I was able to eat small things like crackers and water.   ? acid reflux.   - Acid reflux for around 4 days, despite a limited diet.   *I did not use any OTC medication to treat any of these symptoms.*
Immunized 07/19/02, One week later 07/26/02, had fine red flat rash, blotchy in areas, Soles & palms spared, otherwise covered in rash, Blanches. Awoke early 07/26/02 with rash. Mother states mildly itchy, otherwise fine. No changes in appetite or activity, Vital signs stable, Afebrile
Chills; Fever; Muscles aches; This is a spontaneous report from a contactable physician. An 82-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: 6205), intramuscular, administered in left deltoid on 27Feb2021 (at the age of 82-years-old) as dose 2, single for COVID-19 immunization. Medical history ongoing hypothyroidism, depression and vitamin d deficiency. Concomitant medications included levothyroxine taken for hypothyroidism, paroxetine taken for depression and vitamin d taken for vitamin d deficiency. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN9581), intramuscular, administered in right deltoid on 06Feb2021 (at the age of 82-years-old) as dose 1, single for COVID-19 immunization after which the patient experienced chills, myalgia, pyrexia, pain in extremity, feeling cold, fatigue and arthropathy. The patient experienced chills, fever and muscles aches on 28Feb2021. The patient did not receive any treatment for the events. The outcome of the events was recovered on an unspecified date.  COMMENTS: She had chills, fever, muscle aches with both Covid vaccine. Both times these symptoms started the late evening/ morning after shot and resolved 2 days later. She does not have any tingling symptoms.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Patient started running a high fever the day after his shots of 102.6.  we went to the emergency room and were admitted to another hosptial.  He later started showing more symptoms, including a rash over his whole body, red eyes, red lips, vomiting and diarrhea.  he was transferred to a third hospital where he was diagnosed and treated for Kawasaki Disease.
became ill 3-4 hrs p/flu shot; was still quite ill for 1 day following; began menstruating that day which was 8 days early in cycle; bled heavily for 1 wk; (pt states cycle is always regular & usually bleed for only 3 days);
Vaccine was stored at -20 Degrees F so outside of the Temperature range; A spontaneous report (United States) was received from a pharmacist concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) that was stored at -20 degrees F, so outside of the temperature range.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On an unknown date, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. The reporter stated the COVID-19 vaccine was stored at -20 degrees Fahrenheit; outside of the recommended temperature range. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.  The event, vaccine that was stored at -20 degrees F so outside of the temperature range, was considered resolved.; Reporter's Comments: This case concerns a patient who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting Product storage error without any associated adverse events.
Sore arm was the as first two/second one was little harder; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Sore arm was the as first two/second one was little harder) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006B21A and 031M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Oct-2021, the patient experienced MYALGIA (Sore arm was the as first two/second one was little harder). On 16-Oct-2021, MYALGIA (Sore arm was the as first two/second one was little harder) had resolved. Unknown          No concomitant medications were provided.  No treatment medications were provided.   This case was linked to MOD-2021-363625, MOD-2021-362729 (Patient Link).
body aches; nausea; Fatigue; fever 102; chills; Initial information regarding an unsolicited valid non-serious case received from a consumer via The agency (Reference number- 00335748) and transmitted to Sanofi on 28-Oct-2020.  This case involves a 77 years old female patient who experienced body aches (pain), nausea, chills, fever 102 (pyrexia) and fatigue, while she received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's past vaccination(s) included fluzone with no adverse event, fluzone high dose in 2017 with fatigue and chils, regular Fluzone in 2018 with no adverse event.  The patient's past medical history, medical treatment(s) and family history were not provided.   On an unknown date in 2019, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (lot number not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date in 2019, the patient developed a non-serious body aches (pain), nausea, chills, fever 102 (pyrexia) and fatigue, within few hours following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  Relevant laboratory test results included: Body temperature - On an unknown date in 2019: 102 (unit not reported).   It was not reported if the patient received a corrective treatment.  On an unknown date, the patient recovered from the events (events lasted for 2 days). On the third day, she felt better. This year she received the regular flu vaccine and she felt fine.  There will be no information on the batch number for this case.
This spontaneous report as received from a nurse refers to multiple patients of unknown demographics. The reporter stated that the patients received improperly stored GARDASIL9 (lot number/expiry date unknown) on unknown dates (incorrect product storage). No adverse effects reported. The outcome was unknown. Excursion information for the vaccine: High temperature: 30 minutes at 11.2 degree Celsius. Lowest temperature cumulative: 3 Hours and 17 Minutes at 0.4 degree Celsius. It was confirmed that the vaccines that were incorrectly stored were administered. There were no previous temperature excursions. Data logger was involved. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report was received from a consumer regarding unspecified patients who were 30-40 years old, enrolled in a market research. On an unknown date, unspecified patients was vaccinated with GARDASIL (strength, dose, frequency unknown). All the patients experienced inappropriate schedule of drug administration. Outcome of inappropriate schedule of drug administration was unknown. Reporter considered the event, inappropriate schedule of drug administration to be not related to GARDASIL. Additional information is not expected.
1st & 2nd doses (2nd dose on 27Feb2021) of the Covid-19 Vaccine from Pfizer; This spontaneous case was reported by a nurse and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (1st & 2nd doses (2nd dose on 27Feb2021) of the Covid-19 Vaccine from Pfizer) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (1st & 2nd doses (2nd dose on 27Feb2021) of the Covid-19 Vaccine from Pfizer). On 25-Oct-2021, INTERCHANGE OF VACCINE PRODUCTS (1st & 2nd doses (2nd dose on 27Feb2021) of the Covid-19 Vaccine from Pfizer) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant and Treatment medications was not specified
hives all over the body/ still breaking out in hives where the majority are located his back and now on his arms; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives all over the body/ still breaking out in hives where the majority are located his back and now on his arms) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     The patient's past medical history included Allergy (pollen allergies). Previously administered products included for an unreported indication: SIMVASTATIN.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 27-Mar-2021, the patient experienced URTICARIA (hives all over the body/ still breaking out in hives where the majority are located his back and now on his arms). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) at an unspecified dose and frequency and CALAMINE, GLYCEROL, ZINC OXIDE (CALAMINE LOTION) at an unspecified dose and frequency. At the time of the report, URTICARIA (hives all over the body/ still breaking out in hives where the majority are located his back and now on his arms) had not resolved. Unknown This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives all over the body/ still breaking out in hives where the majority are located his back and now on his arms) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     The patient's past medical history included Allergy (pollen allergies) since an unknown date and Cholesterol since an unknown date. Concomitant products included SIMVASTATIN for Cholesterol.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 27-Mar-2021, the patient experienced URTICARIA (hives all over the body/ still breaking out in hives where the majority are located his back and now on his arms). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) at an unspecified dose and frequency and CALAMINE, GLYCEROL, ZINC OXIDE (CALAMINE LOTION) at an unspecified dose and frequency. At the time of the report, URTICARIA (hives all over the body/ still breaking out in hives where the majority are located his back and now on his arms) had not resolved. Unknown
Pt. states that after receiving the 1st dose of Shingrix 08/19/2021, started experiencing symptoms 08/22/2021 of redness in the middle area of the body lasting 24hrs. Primary Communications recommendation of Observation.
1/26, child fussy & given Tylenol. 1/27, pt leg swollen, leg to upper knee. R/thigh swollen to twice nml size. Called Dr & his nurse told mom not to worry, was nml. Leg is better, tonight, & mom is giving Tylenol every 6 hrs.
Sweating, anxiety. BP 136/83, HR 95, RR 18. Provided with water, juice & crackers, tolerating well. Patient stable 30 minutes after vaccination & released from vaccination site
FLUZONE vaccine received at 0900 hour on 10-21-13. Abruptly at 2015 hour on 10-21-13 employee begin to have chills and shaking. Abruptly at 0830 hour on 10/22/13 chills and shaking resolved. No other symptoms noted. No fever noted on 10-22-13 0800 hour hrs.