chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer via call center representative and described the occurrence of general body pain in a 76-year-old female patient who received SHINGRIX. Concurrent medical conditions included blind (glaucoma diagnosed years ago and she was going blind), glaucoma (left eye glaucoma diagnosed 2 years ago), cancer surgery (twice) and brain operation. Concomitant products included Metformin, Ranitidine, Baby Aspirin, vitamin D, JANUVIA, SYNTHROID and TRAVATAN. On 20th April 2018 14:00, the patient received the 1st dose of SHINGRIX. In April 2018, less than a week after receiving SHINGRIX, the patient experienced discomfort. On 20th April 2018, the patient experienced general body pain and bone pain. The patient was treated with ibuprofen. On an unknown date, the outcome of the general body pain and bone pain were recovering/resolving and the outcome of the discomfort was unknown. It was unknown if the reporter considered the general body pain, bone pain and discomfort to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the right arm. Within 2 hours after vaccination, the patient experienced pain starting in her arm and in her collar bone which got worse and then the pain was from her waist up. If she had the slightest movement, the pain was outrageous. Within 3 hours after vaccination, the patient experienced extreme pain throughout her body and it took her a couple of days to recover. On the following day, 21st April 2018, the patient contacted her physician and he advised her to take Ibuprofen 600 mg immediately and then 200 mg every two hours. The pain started to ease but she carried a residual feeling of being uncomfortable. The patient reported that he collar bone, chest and arm killed her. The patient had no mark or bleeding at the injection site. The patient had no reaction at the injection site. The patient claimed that the pain was resolving at the time of reporting.
Fire Medic Response 70 Y/O Female L Arm Tingling  PT had just received her 2nd Dose of Moderna Vaccine into Left Arm Upon observation PT stated that her Left arm was tingling, Head Tingling Paramedics On Scene assessed PT and Began 911 EMS local response, Upon assessment PT had multi-focal PVC's, Positive Orthostatics. Transported PT via ambulance to Hospital "Moderna Covid19 EUA"
Malignant neoplasm of fallopian tube, malignant neoplasm retroperitoneum?May 2021   9/14?kidney stones?cystoscopy, bilateral ureteral stent placement  Bilateral hydronephrosis, likely RIGHT ureteral stones, ostomy, recent pelvic surgery, new onset NGB with incomplete bladder emptying, acute renal function changes
Temp of 102.1 evening of imms, no redness or tenderness of site.
Patient informed me the day after she got her flu shot, that she broke out in hives a few hours after receiving the vaccination that got worse when she took a shower. She said she took some Benadryl that seemed to help and they eventually went away.
Got flu shot in left deltoid and Gardasil 9 in right deltoid on Tuesday (10/20).  Gardisil stung on injection with some bleeding, but stinging was present in both of other 2 injections in series and they then had essentially no ongoing pain. Both shoulders still a little sore (right greater than left) Friday (10/23) but was able to do a LIGHT 20 min rowing workout. Left arm essentially pain free by saturday 10/24. In right arm on Saturday there was significant pain (worse than previous day) and stiffness in right shoulder.  limited mobility. Difficulty with ADLs (unable to lift arm to brush hair or take on/off shirts overhead without help, difficulty opening drawers/doors with right arm) due to pain. Somewhat responsive to NSAIDS. Pain has gradually lessened by today (day of reporting, 10/30, 10 days post vaccine) but still painful and stiff in mornings and can still illicit 8/10 pain in Right shoulder with certain motions, especially when extended overhead and can barely get shirts on/off. Have not rowed or exercised or anything that could inflame shoulder since 10/23.
Scabs on hands looks like scars, Bumps on forehead and head. Used Cortizone on scars and forehead, as well as head. This has been going on since the 02/07/2021.
indigestion, growing into severe indigestion, then shortness of breath, then soft-serve diarrhea , then big chills, converting to sudden sweats with chills.  Soaked through bedclothes, and was sitting up in bed to reduce indigestion, when the urge to vomit came along... Avoided that, but still upchicked into my mouth three times.  Heart rate increased to pounding, then turned into butterfly flutter, and quickly ended, leaving nothing but sweats and indigestion.  Slept for approx an hour, themn got up @ 5:30am with no residual effect except for heavy tiredness and disinterest.
Patient reported feeling flushed and sweaty 10 minutes after receiving the vaccine. BP 165/74 P 99. SpO2 100%. No shortness of breath. No rash. No prior history of hypertension. BP rechecked after 10 minutes 149/72. Patient reported feeling somewhat improved. Rechecked in another 15 minutes and parent felt back to normal and left clinic.. Checked again by phone at 2:30 PM . "feeling fine"
1-11-22 I had my 3rd shot.  The booster.  the next day on the 12th along with fever 101.8. aches and pains and tiredness I had Afib come and lasted for 30 days persistent,  I have never had it last that long.   The longest episode I have had was 48 hours, one time.  After the 30 days I finally converted  to a normal rhythm for 2 days then went back into Afib.  It seemed possible connected  to the booster shot so I  wanted to report it.
3AM - Severe body aches, extreme nausea, sweats, ad fever, delirium, sleep most of 10-23-10. Lasted about 24 hours.
This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (12 hours post puncture Vial was first punctured on 08Dec2022 and then administered on 09Dec2022) and NO ADVERSE EVENT (No adverse event) in a 75-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7147B) for COVID-19 prophylaxis.     It was reported patient had no medical history/ conditions, allergy, concomitant diseases and risk factor.  Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 vaccine (Batch number: 043L20A.) on 09-Feb-2021, Moderna COVID-19 vaccine (Batch number: 037K20A.) on 09-Mar-2021 and Moderna COVID-19 vaccine (Batch number: 037F21A.) on 17-Nov-2021. Past adverse reactions to the above products included No adverse event with Moderna COVID-19 vaccine, Moderna COVID-19 vaccine and Moderna COVID-19 vaccine.          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 (12 hours post puncture Vial was first punctured on 08Dec2022 and then administered on 09Dec2022).    Concomitant products were not reported.  It was reported that dose administered more than 12 hours post puncture Vial was first punctured on 08-Dec-2022 at 1:10 PM and then administered on 09-Dec-2022 at 8:30 AM. Patient did not report side effects.  Treatment medications were not reported.
I began to feel very dizzy as well as shaky. My heart rate accelerated and I experienced shortness of breath. I called a nurse, and she told me that if my symptoms did not stop soon, then I need to go to the hospital.
The patient returned to the pharmacy shortly after receiving a Janssen COVID vaccine.  He was sweating, pale, clammy, and breathing hard.  We had him sit, helped him calm his breathing; I assessed for wheezing and swelling of the tongue, but he did not have those symptoms.  The patient was able to speak and did not report dizziness or lose consciousness.  Paramedics responded.  I spoke with the patient this morning, and he reports no residual symptoms.
Developed throat tightness and chest tightness later in day of vaccine admin. ~ albuterol neb relieved symptoms. The following day in the mid-morning, she had a reoccurrence of throat and chest tightness and also subsequently developed swollen, tingling and numb lips. She took Allegra 180 mg, prednisone 30 mg ~ symptoms did improve with these. For the next several days, she had intermittent lip tingling and swelling. 3 days s/p vaccine, she developed throat and chest tightness again - no improvement with albuterol but did get improvement with Benadryl. She also developed intermittent tenderness of cervical and occipital LNs and swelling and tenderness in some of her joints (bilateral knees and wrists)
He has received the Pfizer double dose first, he has been double boosted with Pfizer (Confirmed as Pfizer covid 19 vaccine). He tested positive on 12May; He has received the Pfizer double dose first, he has been double boosted with Pfizer (Confirmed as Pfizer covid 19 vaccine). He tested positive on 12May; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 12May2022, outcome "unknown", COVID-19 (medically significant) with onset 12May2022, outcome "not recovered" and all described as "He has received the Pfizer double dose first, he has been double boosted with Pfizer (Confirmed as Pfizer covid 19 vaccine). He tested positive on 12May". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (12May2022) Positive; (17May2022) Negative; (22May2022) Positive. Therapeutic measures were taken as a result of covid-19. Clinical Course: Reporter stated, "husband tested positive with covid last Thursday, 12May. He has received the Pfizer double dose first, he has been double boosted with Pfizer (Confirmed as Pfizer covid 19 vaccine). He tested positive (PC filed) on 12May, our doctor prescribed paxovid which he took for 5 days. He finished paxlovid on Monday, 16May and he tested negative on Tuesday 17May Now this morning which is 22May, he woke up with slight cold symptoms and tested positive again."  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
My blood pressure is through the roof, and have had to double my medication.  I get very, very winded going up only one flight of stairs, and have to sit and rest for one to two minutes after I go up stairs.
Patient stated she was seen in the ER due to hives, trouble breathing and pacemaker acting erratically.
First shot: (left arm) Soar throat (same side as injection), back pain ( same side as injection), chills off and on for a three to four days.  Second shot: (right arm) Back pain and swelling in lower back ( same side as injection), bizarre dreams for several days, irregular heart rhythm,  anxiety,  paranoia
PATIENT WAS FINE IMMEDIATELY AFTER.  ABOUT 13 MINUTES LATER, SHE CAME TO RPH ASKING IF GOOSE BUMPS ARE NORMAL. SHE SAID HER SKIN WAS MORE PINK THAN NORMAL, WHICH RPH COULD NOT SEE.   SHE STARTED HAVING TINGLING DOWN THE ARMS AND LEGS AT APPROX 15 MINUTES.  HEADACHE STARTED SHORTLY AFTER.   NO ITCHINESS, INCREASED HEARTRATE OR RESPIRATORY DISTRESS.   17 MINUTES, PATIENT STATES HER FACE FEELS LIKE A TIGHT MASK.   911 CALLED.  PATIENT IS COMPLETELY RESPONSIVE AND CALM, BUT CONCERNED.  32 MINUTES, MEDICS ARRIVE AND TAKE VITALS.   BP IS ELEVATED, PULSE OX NORMAL, LUNGS ARE NORMAL.  MEDICS STATE THERE IS NOTHING LIFE THREATENING AND PATIENT MAY GO TO THE HOSPITAL IN AMBULANCE OR WITH HER CHILDREN IF SHE WANTS TO.  PATIENT WALKS TO FRONT OF STORE SAYING HER FACE WAS SWELLING.
developed muscle aches, fever, chills, and nausea approximately 15hours post vaccine.  unable to report to work the next day, symptoms resolved
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 06-OCT-2015 the patient was vaccinated with an improperly stored dose of GARDASIL 9 (0.5 ml; lot # K026247, expiration date: 29-JAN-2017; dose, frequency and route unspecified). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion 5 times. The storage criteria was refrigerator (R). The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree/ Celsius), Celsius conversion of the lowest recorded temperature (Fahrenheit degree/ Celsius) and the type of excursion (R/F) for each time were 96, 30, -1.111111111 and R; 120, 29, -1.666666667 and R; 24, 33, 0.555555556 and R; 320, 31, -0.555555556 and R; 160, 32, 0 and R. This is one of several reports received from the same source. Additional information has been requested.
Pt's mother called in the next day to report that her child had a swollen tongue and c/o sore throat - Instructed to give BENADRYL for reaction, but mom said the symptoms had already resolved.
found out she was pregnant after receiving the first dose of the vaccine; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (found out she was pregnant after receiving the first dose of the vaccine) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002a21a) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 07-Feb-2021 and the estimated date of delivery was 07-Jan-2022. On 06-Mar-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (found out she was pregnant after receiving the first dose of the vaccine). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  third week of the pregnancy.  On 06-Mar-2021, MATERNAL EXPOSURE DURING PREGNANCY (found out she was pregnant after receiving the first dose of the vaccine) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Mar-2021, Pregnancy test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product was not provided. Treatment medication was not reported.
Pt reports she developed fever approx 4 hrs after receiving vaccine. Fever/fatigue lasted approximately 24 hrs.
20 years old young rider suffers a heart attack; Initial information received on 27-Jan-2022 regarding an unsolicited valid Social Media serious case received via consumer/non-hcp.  This case involves a male patient of 20 years old young rider suffers a heart attack while receiving vaccine Influenza Vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received suspect Influenza Vaccine (strength, formulation, dose and frequency: unknown) produced by unknown manufacturer lot number not reported via unknown route in unknown administration site. Information on Batch number will not be available for this case  On an unknown date the patient developed a serious 20 years old young rider suffers a heart attack (myocardial infarction) (unknown latency) following the administration of Influenza Vaccine. This event was assessed as medically significant.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (20 years old young rider suffers a heart attack).  At time of reporting, the outcome was Unknown for the event 20 years old young rider suffers a heart attack.; Sender's Comments: Sanofi company comment dated 03-Feb-2022: This case concerns an 20 years old male patient young rider suffers a heart attack after vaccination with vaccine Influenza vaccine. A significant temporal relationship cannot be established due to lack of information on event onset date and product start date and hence, causal role of suspect vaccine cannot be excluded in occurrence of the event. Furthermore, additional information regarding condition at the time of vaccination, lab data excluding other predisposing etiologies, lifestyle/dietary history/habits, pre-existing risk factors, medical history, corrective treatment/medical management, family history for cardiac diseases (at young age) and clinical course details would be needed for complete assessment of the case. Based upon the reported information, the role of an individual vaccine cannot be assessed.
Swelling & redness of entire shoulder bone aching congestion > overnight - pt felt better 24 hr after injection.
massive red sores, about quarter size, raised, all over her head. Started the same day.  She still have them, they are scabbed over almost gone, but still has them. Client cannot walk/stand on her feet d/t pain on the soles of her feet, still cannot walk on them.
4cm x 3.5cm area of redness at site of Varivax vaccine, no treatment required.
Patient called around 6:55 pm on 11/16/2021 informing me that when she woke up this morning she had blurry vision, a little cloudy and everything seemed a little far and asked me if this is common after getting a MODERNA vaccine. She had got her MODERNA COVID-19 vaccine yesterday 11/15/2021  in the evening around 5 pm. She wanted to call us and check with us if that was a common thing after receiving a moderna vaccine. She said she went to the optometrist but was not able to see him and she is going to her doctor.
SIGNIFICANT SWELLING OF BOTH LEGS WITH A FEVER OF 101.6. CHILD WAS VERY FUSSY.
Tremors and numbness noted after Tdap after being bitten by a domesticated dog a day before in community. C/O fever and feeling sick for almost a month now.
No adverse event; Administration error: 26 doses administered to adult patients from pediatric vials instead of bivalent vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Administration error: 26 doses administered to adult patients from pediatric vials instead of bivalent vaccine) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In October 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In October 2022, the patient experienced WRONG PRODUCT ADMINISTERED (Administration error: 26 doses administered to adult patients from pediatric vials instead of bivalent vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Administration error: 26 doses administered to adult patients from pediatric vials instead of bivalent vaccine) 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 assessment was provided for WRONG PRODUCT ADMINISTERED (Administration error: 26 doses administered to adult patients from pediatric vials instead of bivalent vaccine).    No concomitant medication information was provided. On 8 Oct 2022, 9 Oct 2022 and 10 Oct 2022 vaccine was administered. Reporter was not aware of any AEs after the vaccines were given.  No treatment medication reported.  This case refers to patient-18 out of 26 patients.
PT CALLED ON 3-27 TO REPORT A BLOOD CLOT IN HER EYE AFTER RECEIVING THE VACCINE ON 3-13, STILL PRESENT
pt recvd vax & 1 day later exp fever of 102-104, chills, diaphoresis & cough which lasted 5 days & then resolved;
headache; tiredness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): LRN4362815.  A 33-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Sep2022 at 13:15 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 33 years for covid-19 immunisation. The patient's relevant medical history included: "Ulcerative colitis" (unspecified if ongoing); "Ovarian Cysts" (unspecified if ongoing); "Shingles" (unspecified if ongoing); "Wheelchair Bound/Use of a wheelchair" (unspecified if ongoing), notes: Wheelchair Bound/Use of a wheelchair; "Cut her wrists in high school" (unspecified if ongoing); "Multiple Sclerosis" (ongoing); "High Blood Pressure" (unspecified if ongoing); "Walker use" (unspecified if ongoing); "Use of a cane" (unspecified if ongoing); "Right hand swelling" (unspecified if ongoing); "unable to write/Loss of dexterity in right hand" (ongoing), notes: unable to write/Loss of dexterity in right hand; "PML" (unspecified if ongoing), notes: Positive for PML; "Asthma" (ongoing); "Cat Dander Allergy" (ongoing); "Mango Allergy" (ongoing); "Artificial Sweetener Allergy" (ongoing); "Macrobid Allergy" (ongoing); "Panic Attacks" (ongoing); "Costochondritis" (ongoing); "Depression" (ongoing); "Leg Spasms" (ongoing); "Multiple Sclerosis Pain" (ongoing); "Anxiety" (ongoing); "Heart Burn" (ongoing); "Vertigo" (ongoing); "Nausea" (ongoing); "Lack of appetite" (ongoing); "Migraines" (ongoing); "Loss of dexterity in right hand" (ongoing); "Right hand and wrist nerve issues" (ongoing); "Right hand and wrist nerve issues" (ongoing). Concomitant medication(s) included: ALLEGRA [FEXOFENADINE HYDROCHLORIDE]; FLOVENT; FLONASE [FLUTICASONE PROPIONATE]; CELECOXIB; PANTOPRAZOLE; LYRICA; MECLIZINE [MECLOZINE]; TIZANIDINE; ESCITALOPRAM; SUMATRIPTAN; PROCHLORPERAZINE. Past drug history included: Tysabri for Multiple Sclerosis, reaction(s): "Multiple Sclerosis Flare-up", notes: Multiple Sclerosis Flare-up-when switching from Copaxone to Tysabri; Golytely, reaction(s): "Golytely Allergy". Vaccination history included: BNT162b2 (DOSE NUMBER UNKNOWN, SINGLE), administration date: 26Mar2021, when the patient was 32-year-old, for COVID-19 immunization, reaction(s): "100 degree fever", "chills". The following information was reported: FATIGUE (non-serious) with onset 23Sep2022, outcome "unknown", described as "tiredness"; HEADACHE (non-serious) with onset 23Sep2022 at 19:30, outcome "unknown". Relevant laboratory tests and procedures are available in the appropriate section.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Received varicella vaccine SC in right arm on 10/04/10.  pt c/o of itching later on in the day at vaccine administration site.  Twelve hours after receiving vaccine, area of redness, heat and swelling was noted on right arm.
27OCT flu-like sx, nausea, achiness; 1DEC h/a, anorexia, fever, chills, nausea;
Redness, tenderness at injection site, arm was stiff for a few days, difficult to lay on arm.
Injection site inflamed and extremely painful.  Pain and numbness, burning, down arm the first night of injection.   Injection site Still swollen, painful , hyper-sensitive to touch, and red on 9/30/2020.  Not improved at all, no benefit by applying ice, nor tylenol, nor arnica gel for swelling  Sudden onset of FLU Symptoms the night of the injection. approximately 11pm, including extreme headache, fatigue, lethargy, chills, fever up to 103.1, stomach ache, nausea.  Fever resolved with Tylenol but not until 9/29/2020.  Doctor prescribed generic Tamiflu on  9/27.
Admitted with hip pain and incidental finding of Antigne + SARS-CoV-2.
Patient stated that his arm became swollen to twice the size and he could not lift it up.   He also complained of flu-like symptoms for about 1-2 days after the vaccine where he was weak, feverish and in extreme pain.  The swollen arm and arm pain continue to almost a week.