chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Symptoms began the day after the patient received the second shot. He was very tired and weak. By the afternoon, he was so weak he could not lift himself out of the chair. Even with the help of another person, he was too weak to stand. I called for emergency help. He had a fever of 101, was vomiting, very disorientated, confused, could not understand what people were saying to him. At the hospital he continued to feel disorientated, had nausea, dizzyness, a headache, a fever of 104, was dehydrated. He was admitted to hospital and spent one night. Once home, he has begun to regain strength and other symptoms have diminished. Four days after coming home he is feeling stronger and more back to normal.
This spontaneous report was received from a physician via company representatives and from a support services director concerning to a patient of unknown age and gender. The patient's concurrent conditions, medical history, and allergies were not reported. Concomitant therapies were not provided. On 19-JUL-2016, the patient was vaccinated with an unspecified improperly stored dose of RECOMBIVAX HB "10 microgram/1 ml, 10X1 DS/V TF" with lot number L042846 and expiration date of 15-SEP-2017, (dosage schedule, route and anatomical location were not reported), which was stored at 12 Celsius Degrees for 144 hours. The type of excursion and the storage criteria were reported as refrigerator (R) and the vaccine status in excursion. No adverse effects were reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Fever up to 104.4 times 4 days; uncontrolled chills; Weakness; body/ joint aches; body/ joint aches; This is a spontaneous report from a contactable consumer (patient). A 52-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 16Mar2021 16:00 (at the age of 52-years-old) (Batch/Lot Number: EN6208) as single dose for COVID-19 immunisation. Medical history included Pulmonary embolism, Heartburn. The patient had no allergies to medications, food, or other products. Concomitant medication(s) included apixaban (ELIQUIS); dexlansoprazole (DEXILANT), both taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since 18Mar2021 16:00, the patient experienced fever up to 104.4 times 4 days, uncontrolled chills, Weakness, body/ joint aches. The events resulted in Doctor or other healthcare professional office/clinic visit. No treatment received for the adverse event. The reporter assessed the events as non-serious. Since the vaccination, the patient had not been tested for COVID-19. Outcome of the events was recovered with sequelae (Recovered with lasting effects).  Follow-up attempts are completed. No further information is expected.
Swelling and redness noticed by mother left arm deltoid region has a 6cm x 10cm area of redness and induration.
Confusion, Dizziness,  11:33 Tingling in forehead BP 137/87 HR 91 O2 98% 11:48 138/84 HR 79 O2 100%. Felt better Narrative:
Patient no apparent Illness or Injury onsite EMS was called vitals 160/92   97% O2 HR 78. Patient refused evaluation and care, released againt medical advice.
Enlarged lymph nodes under left arm painful. Pain all around left upper arm bicep. Took Ibuprofen and applied heat ROM affect in left arm.
Got a calcified lump where she received the vaccine.  Also got cold like symptoms  10 days after vaccine.  Now has a severe anaphylactic reaction to peanuts. Also reacted to eggs as a baby and reacts with FPIES to dairy.
Fever, chills, profuse sweating, fatigue, sore arm all starting about 6 hours after vaccine. Cleared up after 48hrs. Starting shortly thereafter and continuing for about 2 weeks experienced spasms in my head almost like sharp pains like a migraine that were occuring every few seconds. Went away after 2 weeks or so
SHAKINESS.  V/S TAKEN:  140/70, 78, 16, 98%(RA)
I had the Shingle shot and still got the Shingles/Suspected vaccination failure; I had the Shingle shot and still got the Shingles; it's horrible and very painful; This case was reported by a consumer  and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by the patient. The age at vaccination was not reported. The patient had the Shingle shot and still got the Shingles.  The patient stated that the shingles were horrible and very painful. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory test confirming shingles were unknown at the time of reporting.
Open ipol stored total time out of range is 15 minutes with a maximum temperature of 47.34F reported with no reported adverse event; 3 patients received a dose from the open vial after a routine clinic activity caused a temperature excursion reported with no reported adverse event; Initial information received on 01-Aug-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patient and reporter reported temperature excursion for Poliomyelitis Vaccine (Inactivated) IPV (VERO) (IPOL)/open vaccine stored total time out of range is 15 minutes with a maximum temperature of 47.34f reported and 3 patients received a dose from the open vial after a routine clinic activity caused a temperature excursion reported with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patients received an unknown dose of suspect Poliomyelitis Vaccine (Inactivated) Suspension for injection (with an unknown expiry date, strength and lot number) via unknown route in unknown administration site for prophylactic vaccination (immunisation).  On 24-Jun-2023, the reporter reported temperature excursion for Poliomyelitis Vaccine (Inactivated) IPV (VERO) (IPOL)/open vaccine stored total time out of range is 15 minutes with a maximum temperature of 47.34f reported and 3 patients received a dose from the open vial after a routine clinic activity caused a temperature excursion reported with no reported adverse event. (product storage error) (unknown latency) (poor quality product administered) (latency: same day).  Action taken: not applicable.  Outcome: Unknown   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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.
This is a spontaneous report from a contactable physician (pediatrician) received via a Pfizer sales representative and from a contactable nurse. An 18-year-old female student patient of unspecified age ethnicity and gender received the 1st dose of TRUMENBA (Batch/Lot M95612, exp. date Jul2017) IM at 0.5ml single dose at right deltoid on 22Jun2016 09:30. The 2nd was due on 22Dec2016. Medical history was not reported. There were no concomitant medications. On same date along with suspect vaccine she received: the 1st dose of Hepatitis A (Merck, Lot# L045713) IM at left deltoid. No other vaccinations within 4 weeks prior to date of vaccination was received. The patient stated that it was very tender, it's like a bruise, site was raised a bit of pink and it was warm and it was shape of the triangle with one inch line, and also had lump which lasted 2-3 wks, all on 22Jun2016. No specific tests and/or treatment required and the patient recovered on 29Jun2016. The AEs did not require an emergency room or physician visit. The reporter assessed the events as related to TRUMENBA. The nurse stated that the patient provided to him/her information regarding the reported adverse events with the use of the suspect. The nurse considered there was a reasonable possibility that the event is related to suspect product. The nurse was willing to be contacted again by Pfizer on the reported adverse events. Follow up (09Aug2016): New information reported from a contactable nurse included: patient age and gender; vaccination data; Event onset/recovery date: new event (had a lump); vaccination history; no treatment; reporter informed regarding the adverse events; reporter event causality assessment; reporter further contactability.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Hypertension-Medium, Additional Details: Patient said she sat down after vaccine. She said as she was sitting she passed out and fell to the side and hit her head on top. She had a small amount of blood in her hair.  We sat her back in a chair and her bp was taken --169/96 and pulse 80. 911 was called and paramedics came to check her out. They said she was okay and she said she was okay to drive. She left on her own.
This spontaneous report was received from a medical assistant and refers to a 4 year old patient of unknown gender. No information was provided regarding the patient's concurrent conditions, medical history or concomitant medications. On 22-AUG-2018, the patient was vaccinated with two doses of the pediatric formulation of VAQTA 25/0.5, with lot# R002086 with expiration date on 22-APR-2019 for prophylaxis (dose and route of administration). No adverse event was reported.
At 7 hours after getting the vaccine, I nearly passed out. I got extremely dizzy and lost my hearing for a bit.
On 05/21/2021 I developed left calf pain and tenderness. On 05/22/2021 I began to feel a lump inside my left calf. I went to my local urgent care and they sent me to the local emergency department for an ultrasound. I went to the emergency department where they had this finding: your ultrasound does not found DBT (blood clots). I was discharged for symptomatic care. They did not prescribe any medications. The problem did resolve in the next couple of days and has been gone ever since.
Patient began experiencing acute hives across their entire body beginning 5 to 6 days after receiving the J&J janssen covid-19 vaccine.  Hives will appear on bith arms & hands, both arms & feet, torso, and face. the Patient has been treating with topical over the counter cortizone cream, and taking recommended (2 tablets every 6 hours as needed) doses of over the counter allergy medicine. (Benadryl Allergy, Dipenhydramine HCI 25mg)
PATIENT COMPLAINED OF SWELLING, REDNESS AND HIVES. HER CAREGIVER STATED SHE HAD USED A COLD COMPRESS AND THAT WAS HELPING. PHARMACIST ADVISED HER TO GET SOME  ANTIHISTAMINES, TAKE PICTURES OF REACTION PROGRESSION AND WATCH FOR ANOTHER 24-48 HOURS TO SEE IF ANY IMPROVEMENT, IN NONE THEN TO CALL PHARMACIST AND CONTACT PHYSICIAN.
Mouth & tongue sores, gingivitis, white-coated tongue w/red patches, sand-paper sensation to tongue & throat, raised, striated, white lines on both inner cheeks.  Began gradually and progressed over time, as described above.
headache; Chills; Rash; Pain; Shingles; Swollen lymph nodes; Pain on left hand side near ribs where she thought it was possibly the spleen; Stiffness in left side of neck; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of ABDOMINAL PAIN (Pain on left hand side near ribs where she thought it was possibly the spleen), MUSCULOSKELETAL STIFFNESS (Stiffness in left side of neck), PAIN (Pain), HERPES ZOSTER (Shingles) and LYMPHADENOPATHY (Swollen lymph nodes) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 004M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported).   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Feb-2021, the patient experienced ABDOMINAL PAIN (Pain on left hand side near ribs where she thought it was possibly the spleen), MUSCULOSKELETAL STIFFNESS (Stiffness in left side of neck) and LYMPHADENOPATHY (Swollen lymph nodes). On 09-Feb-2021, the patient experienced PAIN (Pain), HERPES ZOSTER (Shingles) and RASH (Rash). On 10-Feb-2021, the patient experienced HEADACHE (headache) and CHILLS (Chills). At the time of the report, ABDOMINAL PAIN (Pain on left hand side near ribs where she thought it was possibly the spleen), MUSCULOSKELETAL STIFFNESS (Stiffness in left side of neck), PAIN (Pain), HERPES ZOSTER (Shingles), LYMPHADENOPATHY (Swollen lymph nodes), RASH (Rash), HEADACHE (headache) and CHILLS (Chills) had not resolved. Not Provided          Most recent FOLLOW-UP information incorporated above includes: On 16-Feb-2021: No specific follow-up information recorded.
Patient reports after Hepatitis B vaccination #1, patient experienced racing heartbeat, nausea, fatigue and headache throughout the day. Pt reports symptoms did not occur at the same time and did not last for long. Pt reports felt fine the next day. Pt states she did not feel the symptoms were severe enough to report to the health department or her primary physician. Pt denies difficulty breathing, chest tightness, hives, itching or swelling after Hepatitis B injection.
Initial report received from the pt's parent who is a health care professional, on 04Oct05. An 18 yr old female pt, had received a first dose of Menactra, lot number unk, on 21Aug05. The route and site of admin were not reported. 38 days post vaccination, the pt awoke at 1:00AM and could not move her legs until 6:00 AM. She had feeling in her legs during that time, but was unable to move her legs. The entire limb was affected. The pt also complained that her right arm felt asleep, although she was able to move it. Once on her feet, the pt had some residual numbness. The numbness lasted for three days. She was seen by a neurologist on 29Sep05 and tests were scheduled, including an EEG on 07Oct05. It was reported that the pt also has newly diagnosed Crohn's disease. The pt's recovery status is unk. Records rec'd 10/20/2005, box 7 complete. Information from Follow-up report states: I call the mother/reporter who is the RN who gave her daughter the vaccine. The mother states that the vaccine ws Menomune, not Menactra. The mother stated that she gave her daughter Memomune on 8/21/05. On 9/28/05, woke up in the middle of night unable to move legs and arm. Went to ER Memorial Hosp. At ER, arrived at 1:30 and doctor thought she was faking. They wanted to send her to a psych unit. She could move arms but not legs. At 5:30 in the morning, she could move legs with distress. Then the ER doctor said she may have GBS. Was referred to a neurologist. He didn't think it was GBS. He thought she had pinched nerve, wanted to do EEG, EMG and BEAR(?) test. Now gettig EEG, BEAR today. On Oct 11 will get the EMG. Symptoms now numbness in feet, legs hurt but not numb. Bone pain. She is able to walk and to move and to manover her legs. Diagnosed with Croh's disease since the vaccine. Will have UGI and LGI with biopsy on Monday Oct 10 to confirm this diagnosis.
One week after shot, on 2-27 21, I awoke with splitting headache, muscle pain in my neck, nausea, a few chills (they did not last long), felt horrible for about 5 hours. I threw up midway, and then just slept. Felt a little better around 2:00 pm, took Tylenol at 4:00pm and that helped a lot. Got out of bed at 5:00 pm. Was able to eat a little dinner at 6:00 pm. Went back to bed around 9:00. Felt better in Am -Sunday, Feb 28; not 100% though. Tired. Long nap. Better today, Mar. 1.  -- just a little off - woozy.
Patient complained of throat closing up, burning eyes, wheezing, no rash after leaving clinic at night. Patient states was doing fine next AM. Patient declined to return to clinic.
outbreak of shingles; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (outbreak of shingles) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Shingles. Concomitant products included VALACYCLOVIR [VALACICLOVIR] for Shingles.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HERPES ZOSTER (outbreak of shingles). At the time of the report, HERPES ZOSTER (outbreak of shingles) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided.
Mutliple sclerosis; hives; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): LRN4389781 (Genetech).  A 57 year-old female patient received bnt162b2 (BNT162B2, solution for injection) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Seasonal allergy" (unspecified if ongoing); "Unable to walk" (unspecified if ongoing); "Allergies to nickel" (unspecified if ongoing); "Perfumes" (unspecified if ongoing); "Citrus fruits" (unspecified if ongoing); "Peanuts" (unspecified if ongoing); "Weakness" (unspecified if ongoing); "Arthritis" (unspecified if ongoing); "COVID-19" (unspecified if ongoing); "UTI" (unspecified if ongoing); "Blood clot" (unspecified if ongoing); "loss of right hand function" (unspecified if ongoing). Concomitant medication(s) included: OCREVUS; SENOKOT; IBUPROFEN; VITAMIN B6; VITAMIN B12 NOS; DALFAMPRIDINE. The following information was reported: MULTIPLE SCLEROSIS (medically significant), outcome "not recovered", described as "Mutliple sclerosis"; URTICARIA (non-serious) with onset 08Feb2021, outcome "recovered", described as "hives". Patient's concomitant medication included blood thinner, multivitamin and antihistamine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
12/19/21 Developed acute pancreatitis. Severe abdomen pain (pain worse than labor), could not lay down or eat, liquid diet for several weeks, lost 30 pounds, lasted well into March 2022.  33 y/o breastfeeding mom, no alcohol or medication, no gallbladder issues and otherwise idiosyncratic acute pancreatitis 12/23/21 Went to ER because pain so bad, left without being seen 12/27/21 Telemed visit 12/28/21 CT Scan at urgent care visit confirming pancreatitis
Patient returns to vaccine location two hours after vaccine, stating within minutes she had sensation of tingling on the left side of her face and tongue. No other symptoms. Vaccine clinic was closed for the day, encouraged to seek care at an acute care. Confirms understanding.
Chills,  fever (99.6 -101.2), ached all over.  Lasted over a 48 hour period.  Did not seek medical treatment. Took ibuprofen .
pt recv vax APR97 & OCT97 lab eval revealed a lack of response;
Dose administered after 12 hours of vial puncture/Dose administered after being more than 24 hours at room temperature; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 12 hours of vial puncture/Dose administered after being more than 24 hours at room temperature) in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 12 hours of vial puncture/Dose administered after being more than 24 hours at room temperature). On 13-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Dose administered after 12 hours of vial puncture/Dose administered after being more than 24 hours at room temperature) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medications were provided No treatment medications were provided.  The vial was exposed to room temperature range (8 degrees Celsius to 25 degrees Celsius/46 degree Fahrenheit to 77 degree Fahrenheit) for around 30 hours. On 12-Oct-2021 at 8 A.M, the vials were taken out of the fridge to room temperature. The vial did not undergo any temperature excursion.
On Sunday the 27th I began feeling mild RLQ abdominal pain of about a 2-3 on the VAS near an  abdominal scar. I treated it with a warm compress overnight. By 7 am  on the 28th ,the pain had escalated to a 5 and my clothing was extremely uncomfortable. By 930 am I was doubled over in pain and in tears. I drove to the nearest Urgent Care Facility as I thought I had appendicitis. By the time I arrived at UC I could only walk bent over at the waist and was in extreme pain. I was evaluated for appendicitis and an ovarian torsion. CT and US were unremarkable so I was dc'd home without any medication. I told the physician and nurse that I was unable to walk so they wheeled me out and put me in a vehicle. Told me to rest and return if my symptoms became worse. On the 29th I began feeling nauseated and started running a fever of 100.8. I controlled this with advil and tylenol every 2 hours. I was in excruciating pain and called my nurse advice line. They said my only option was to go to the ER. I declined. On the 30th  (today) I am still unable to walk and move out of a reclined position with my feet elevated. My temperature is down to about 99.1. I have a headache, and still no appetite. The pain is a bit better. Probably a 6 on the VAS. The pain is  radiating from my RLQ around to my right flank. My legs are achy and I feel flush. I can barely make it to the restroom unassisted. The pain is unreasonable at this point. I am having a video visit with a PCP shortly for advice and/or prescription help.