chrisvoncsefalvay/vaers-outcomes huggingface dataset:
It's a week after I received my first dose, my left outer arm below the injection site has a red oval swelling that is about 2 1/2 inches long and 2 inches wide with a faint red narrow tail of about two inches extending down my arm.  The swollen area is warmer than the rest of my arm. My arm started bothering me last night when I was sleeping; it woke me,  just felt funny.  When it nagged at me today I scratched and then thought to look at my arm.  I noticed I had scratched a few times before because the scratch marks had scabs.  My arm doesn't hurt though and it does not affect my regular activities.  I was anxious because I did not know if it would lead to more swelling.  Now I have read about  "COVID arm" so I will stop worrying.  Thank you.
Vaccine administered on 09/15/2021 after the expiration date of 09/10/2021.
Pt brought to clinic on 24OCT91; devel hives on face, arms, & wrist; stated woke up on 22OCT91 & lt eye was swollen shut & had hives; Mom also stated pt had fever & diarrhea on 22OCT91; pt given APAP & advised to contact MD for eval;
That Sunday morning, I woke up with a very bad headache. I normally have migraines, but this was not one. I had a lot of pressure in my head. I was very warm, but I can't remember if I had a fever. I was congested in my head and achy all over. I completed an at home COVID-19 and it was positive. I contacted my doctor. He prescribed Paxlovid. I was already taking Mucinex and Ibuprofen. I did notice I had loss the sense of smell. I applied Vicks vapor rub and could not smell it. My headache went away within an hour of taking the initial dose of Paxlovid. The aches went away also but the congestion remained for 3 to 4 days. By that Saturday the symptoms were all gone. It took about 7 days or so.
Fever, body and joint pain, terrible Headache, chills, unable to sleep through night, gland  pain
Patient received DTaP in LA thigh 8/28/07 she comes in today with erythema at the site, an area of 4 x 4 cm. Rash on chest since this AM act eczema on hands-Benadryl 12.5 mg PO given
A report has been received from a Health Professional concerning a 1 year old, male subject, who had been receiving Nasal FLUMIST QUADRIVALENT. The patient's concurrent disease(s) included Down syndrome and chronic lung disease. Concomitant medications included Salbutamol and Budesonide for asthma and paraffin, liquid, petrolatum, wool fat. FLUMIST QUADRIVALENT started on 14-Oct-2013. The FLUMIST QUADRIVALENT administered to a patient with asthma and Down syndrome on 14-Oct-2013. The outcome of the event of FLUMIST QUADRIVALENT administered to a patient with asthma and Down syndrome is unknown. The report was considered to be non-serious.
This case was reported by a pharmacist via call center representative and described the occurrence of contusion in a 59-year-old female patient who received SHINGRIX (batch number X3M27, expiry date unknown). On 20th March 2018 11:20, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In March 2018, less than a day after receiving SHINGRIX, the patient experienced contusion, skin discoloration, skin warm, pruritus, swelling and pain. On an unknown date, the outcome of the contusion, skin warm, pruritus, swelling and pain were recovered/resolved and the outcome of the skin discoloration was recovering/resolving. The reporter considered the contusion, skin discoloration, skin warm, pruritus, swelling and pain to be related to SHINGRIX. Additional details were provided as follows: The health care professional called to report that within 24 hours of vaccination, the patient experienced local reaction of bruising, swelling, pain, and warmth to the touch. The pain lasted for 1 week and then she had residual pain for another 2 weeks. The patient also experienced itching which started after the pain went away (less than a month after vaccination). Everything had resolved except for faint discoloration in which the health care professional described as a distinct line that went from the deltoid to the elbow. This was resolving as well but had not fully resolved till the time of reporting. The patient was the health care professional's hairdresser and she told him the main issue she had was that she used her arms to cut hair all day and she experienced a lot of pain and this was bothersome for her.
Terrible stomach pain like acid indigestion, rAdiating I go back. Pain in stomach is a the v of rib cage. In aback also. Nothing  takes pain away feel hungry but an M not. Tried Prilosec, no help.  It's upper gi. Dull, growling, acid pain but also in back. 6 hrs after shot had slight fever, chills. Lasted 2 days. Fatigue.  5 days after had a feeling for a mini mini second  of feeling like earthquake . Then the stomach, back.
Severe pain emanating from the spinal cord, through the left shoulder and arm, until a tingling numbness in the left hand. Pain has since subsided from the spine and only into the shoulder with numbness in the hand. Red inflamed rashes or raised ?splotches? over painful areas found around the scapula and lower lat.
Uncomfortable pain and  abnormal feeling of the left arm and electrical sensation in arm. Developed thrombus of the Left internal jugular, subclavian, axial and brachial vein. Requires to be fully anticoagulated for 3 months. With repeat Ultrasound in 3 months to confirm resolution of thrombus's.
Patient brought to the ED by EMS on 11/15 with cough, weakness, fever, chills, and sweats that started 6 days prior. Patient also reported he noticed his shortness of breath was getting worse. He tested positive for COVID-19 by PCR in the ED. Ultimately patient admitted on 11/15 with acute hypoxic respiratory failure likely due to COVID-19 pneumonia. Oxygen saturations were in high 80s and patient was placed on 1-2L oxygen nasal cannula. He was able to eventually be weaned off oxygen. Patient discharged 11/18/22. He has received the primary COVID vaccine series and two boosters.
Cellulitis at injection site, red, warm, and swollen 10 days post vaccine.   Treatment: Amoxicillin x 7 days
This is a spontaneous report received from a contactable consumer or other non-health care professional. A 31-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: FC3182), via an intramuscular route of administration, administered in Arm Left on 30Aug2021 (at the age of 31-years-old) as dose 2, single for COVID-19 immunisation. Medical history included , asthma from an unknown date and unknown if ongoing Diagnosed as a child. The patient concomitant medications were not reported. Patient received vaccine facility in Pharmacy. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: FA7485) via an unknown route of administration, administered in Arm left on 09Aug2021 (at the age of 30-years-old) as dose 1, single for COVID-19 immunisation. The patient would like to report that she got her last dose 30Aug2021, and for the past couple of days, at the injection site, after a long period, left arm feels like pressure and is irritated and tight. It feels weird like and when she just gets shot where it is irritated. It was right where she got the last dose. She wanted to know if that was normal to feel this after such a long period of time. She stated she is a biomedical technician. Patient not visited emergency room and physician office. The outcome of the event limb discomfort was reported as not recovered and while for other events was unknown.
After 45 minutes post vaccine my tongue felt fat. I did not have trouble breathing or swallowing. After approximately 1hour the tongue no longer felt fat but started feeling rough  and a red spot about 1/4 inch has developed on the top/side of my tongue.  I have not consulted treatment at this time.
Possible incorrect administration of second dose; This spontaneous case was reported by a consumer and describes the occurrence of INCORRECT DOSE ADMINISTERED (Possible incorrect administration of second dose) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007B21A and 023M20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in July 2020 and COVID-19 in December 2020.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Apr-2021, the patient experienced INCORRECT DOSE ADMINISTERED (Possible incorrect administration of second dose). At the time of the report, INCORRECT DOSE ADMINISTERED (Possible incorrect administration of second dose) had resolved. Not Provided          It was reported that instead of the injection being done straight into the deltoid muscle, the administrator pinched the skin on the deltoid and then administered the vaccine.  Concomitant Medications were provided by the reporter. Treatment Medications were Provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2021-070365, MOD21-071030, MOD21-071138 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-070365:Case for first dose MOD21-071030:cross linked case MOD21-071138:cross linked case
pt recv vax & felt dizzy & sick & devel red & swollen inj site 2hr p/vax;pt devel a flu-like illness, exhaustion & muscle aches & pains which resulted in prolonged time off work;sx ongoing & are now being assoc w/inability to concentrate;
I started off short of breath gasping for air plus muscle weakness in addition swollen ankles. Doctor prescribed diacritics .
vaccines from vials that had been thawed more than 30 days ago were administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccines from vials that had been thawed more than 30 days ago were administered) in a 43-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccines from vials that had been thawed more than 30 days ago were administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (vaccines from vials that had been thawed more than 30 days ago were administered) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication  was reported. No treatment information was provided by the reporter.
OBSTRUCTIVE SLEEP APNEA 2/24/2023 ABNL LUNG IMAGING CHRONIC RESPIRATORY FAILURE 1/12/2023 ABNL LUNG IMAGING
The vial was initially stored in the refrigerator on 03-AUG-2022 and administered on 08-Sep-2022; No adverse event; Dose administered after 30-day Use By Date; Received Monovalent booster instead of Bivalent booster; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date), INCORRECT DOSE ADMINISTERED (Received Monovalent booster instead of Bivalent booster), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 03-AUG-2022 and administered on 08-Sep-2022) and NO ADVERSE EVENT (No adverse event) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 061B22A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Sep-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Sep-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) and INCORRECT DOSE ADMINISTERED (Received Monovalent booster instead of Bivalent booster). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 03-AUG-2022 and administered on 08-Sep-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date), INCORRECT DOSE ADMINISTERED (Received Monovalent booster instead of Bivalent booster), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 03-AUG-2022 and administered on 08-Sep-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date), INCORRECT DOSE ADMINISTERED (Received Monovalent booster instead of Bivalent booster) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 03-AUG-2022 and administered on 08-Sep-2022).    No concomitant information was reported. It was reported that patient received monovalent first booster of Moderna COVID-19 vaccine. The vial was individual vial and size of the vial was 5.5ml red cap. The vial did not underwent any temperature excursions. No treatment information was provided.
SNEEZING; DRY COUGHING; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had not been infected with Covid in the past. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced sneezing, and dry coughing. Laboratory data (dates unspecified) included: COVID-19 antigen test (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sneezing, and dry coughing. This report was non-serious. This case, from the same reporter is linked to 20210665584.
Chills, fever (no temp reported) day after receiving vaccines. Today symptoms resolved. Has a cough.
Day 8 post vaccination in upper right arm I awoke to a pink itchy blotch around the injection site - approximately 2 by 2 inches. Over the course of the day the blotch grew in size and in itch intensity and became sore, warm to the touch and somewhat hardened.. After reading about "Covid arm" in online sources, I treated with topical steroid cream. The blotch continued to increase in size on the following day but decreased somewhat in intensity. Final size approximately 5 inches long and 3 inches wide. Third day blotch was improved and continued to improve daily. Itching was much diminished. By Day 6 blotch could still be seen but was non-reactive. Today is Day 14 and I can still see a telltale sign of the original blotch but is totally non-reactive. I did contact my primary care MD and sent photos of issue. She suggested I report. Nurse followed up with phone call regarding recommendations for second dose.
Today employee stated that in the evening the day of receiving vaccine that he started to feel feverish. Employee reported having fever of 101.4 degrees for two days afterwards, fever then resolved. Employee states he took over the counter ibuprofen the day after the vaccination.
Pt. came in 8/16 to tell me about rxn. He felt that I gave him his shots too aggressively and caused a rxn - red and warm to touch on bicep of right arm. He also stated his BP was high on 8/15. I diverted him to his Dr.
Mother put pt to bed the noc of 09/30/05 - went to wake up next morning - baby was blue and no breathing. Records rec'd 11/7/05 - additional term Status Asthmaaticus. ER records received which revealed patient arrived in full arrest & was unable to be resuscitated. Autopsy report received which revealed COD as asphyxia, smothering in face down position on mattress.  Patient was cosleeping w/2 adults & male adult was lying directly on back of patient's head.
Patient presented to HD on 10/20/23 for immunizations, patient given wrong vaccine. Patient was given Menquadfi when not due for this vaccine. Vaccine error was noticed on 10/25/23 when doing vaccine count. RN called/notified patient, parent of patient reports no problems after vaccination.
I have had shingles on the left side of my face previously- when my white count goes too low. However, I got it this time on the right side of my torso.
FOGGY FEELING IN HEAD; FATIGUE; NAUSEA; This spontaneous report received from a patient concerned a 60 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included sulfonamide allergy, non smoker, and alcohol user, and other pre-existing medical conditions included the patient did not have any drug abuse or illicit drug usage. The patient experienced drug allergy when treated with clindamycin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201a21a, and expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced foggy feeling in head. On 09-APR-2021, the subject experienced fatigue. On 09-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fatigue, nausea, and foggy feeling in head. This report was non-serious.
had the 2 part vaccine, still get shingles/suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, several years after receiving Shingles vaccine and 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 and Shingles vaccine.     Additional Information: GSK Receipt Date: 19-APR-2022 Reporter's Comments:  This case was reported by a consumer via interactive digital media. The case was reported by patient. The patient stated that he/she had the 2 part vaccine series several years ago but still got shingles. The patient asked if he/she was immunocompromised. Additional Supportive Information: The case was considered as suspected vaccination failure since the details regarding the laboratory confirmation was not reported.
hospital ruled out HSP; swelling on legs; abdominal pain; Vomiting; dehydration; wrist swelling; rash on the legs-petechiae; Initial information was received on 08-Jun-2020 regarding an unsolicited valid serious case from the physician.  This case involves an 11 years old female patient who developed HSP (henoch-schonlein purpura) with swelling on legs (peripheral swelling), abdominal pain (abdominal pain), vomiting (vomiting), dehydration (dehydration), wrist swelling (joint swelling) and rash on the legs-petechiae (petechiae), while she received vaccines DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] and MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].  The patient's medical history, past medical treatment, vaccination and family history were not provided.  The patient's concomitant medication was not reported.  On 18-May-2020, the patient received a 0.5 ml dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot U66502A and expiration date was not reported) via an intramuscular route in the left deltoid for prophylactic vaccination.  On 18-May-2020, the patient received a 0.5 ml dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot U659694 and expiration date was not reported) via an intramuscular route in the left deltoid for prophylactic vaccination.  On an unknown date, the patient developed serious HSP (henoch-schonlein purpura) with swelling on legs (peripheral swelling), abdominal pain (abdominal pain), vomiting (vomiting), dehydration (dehydration), wrist swelling (joint swelling) and rash on the legs-petechiae (petechiae) (unknown latency) following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE and DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. These events were assessed as medically significant.  It was reported that on 21-May-2020 patient was admitted to the hospital (hospitalization) with abdominal pain, vomiting, dehydration, rash and swelling on her legs. The hospital ruled out HSP, patient was given IV fluids and discharged. Later that same day, patient went to the emergency department with complaints of wrist swelling, and rash on the legs-petechiae. The patient was then diagnosed with HSP and steroids were administered  Relevant laboratory test results included: On an unknown date, the blood pressure and protein in urine were elevated.  Final diagnosis was henoch-schonlein purpura.  Other corrective treatment was not reported.  At the time of reporting, the patient was recovering from wrist swelling. On an unknown date, the patient had recovered from abdominal pain and outcome for other events was not reported.  Patient parents are concerned that the vaccines caused this reaction.; Sender's Comments: This case concerns an 11-year-old patient who presented with Henoch-Schonlein Purpura after vaccination with MENACTRA and ADACEL. The time to onset is compatible. The laboratory data shows elevated urine protein and patient had elevated blood pressure. However, patient's medical condition at the time of vaccination were not reported. Moreover, two different vaccinations preceded the events. Based upon the reported information, the role of an individual vaccine cannot be assessed.
First noticed itching at injection site two weeks post dose. Noticed redness on skin 4cmx4cm. Not painful. No treatment at this time.
Immediately after the immunization, the injection site bled & showed signs of swelling & raised up. Pt's blood pressure dropped to 70s/50s & started to feel dizzy, get cold, & couldn't bare to get up. Roughly 10-15 min passed & pt's face started to feel puffy & throat felt tighter. 911 was called. She took a 25mg BENADRYL & started to feel better in 5-10 min. Paramedics showed up after & assessed her vitals & past history. She improved in the time they were there and went home shortly after.
2/15 (day 4 following injection) dev rash on chest, no itch.   Twelve hours later developed rash on both forearms which was itchy.  Then rash dev on her back and abdomen, and dev severe itch in vaginal and rectal area.       Eval in Minor Emergency center 2/19.  Prescribed Prednisone orally, which she has not started, and also Triamcinolone cream which she is applying as needed.   2/21 developed rash on back of upper thighs.
The patient came in with his wife 2 days after receiving the immunization. He had some noticeable swelling in his arm where the shots had been administered, and he said that the swelling was going down. His wife had a mild allergic reaction to one of her immunizations, and he was only reporting his, because she was reporting hers. They both said they didn't believe that we had done anything incorrectly. I gave the patient an ice pack at no charge, and asked him to let us and his doctor know if the swelling started getting worse again, or if he had any other adverse reactions.