chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fever of 103, sluggish, lethargic, not eating or drinking for 3 days. Up all night. Crying and screaming a lot.
TD given 12/29. Pt noted swelling, redness, tenderness at site of inject. L upper arm mild itching. Inflamation inc in size 15x12 cm on 4th day.
Janseen COVID-19 Vaccine EUA  headache, feeling very tired, muscle aches, nausea and fever. Onset started about 8 hrs after vaccine and subsided about 12 hours later leaving slight headache and muscle pains.
achy arm; tired; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (achy arm) and FATIGUE (tired) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 07-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-May-2021, the patient experienced VACCINATION SITE PAIN (achy arm) and FATIGUE (tired). At the time of the report, VACCINATION SITE PAIN (achy arm) and FATIGUE (tired) had resolved. Not Provided          No treatment medications were reported. No concomitant medications were reported. Patient declined for further follow-up and declined consent to speak to her HCP for events.   This case was linked to MOD21-073300 (E2B Linked Report). This case was linked to MOD21-073300 (Patient Link).; Sender's Comments:  MOD21-073300:Link to Dose 1 MOD-2021-073116
Complaining of Shortness of breath, pt placed on bipap. Pt treated with diuretics, iv abx and dexamethasone. Pt discharged home.
fever; chills; headache; underarm started to swell/ arm was so swollen that I couldn't put it down to my side; arm is sore. I had it in my left arm/ really sore, hurts; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (underarm started to swell/ arm was so swollen that I couldn't put it down to my side), PAIN IN EXTREMITY (arm is sore. I had it in my left arm/ really sore, hurts), PYREXIA (fever), CHILLS (chills) and HEADACHE (headache) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 065F21A, 003A21A and 022M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Nov-2021, the patient experienced PERIPHERAL SWELLING (underarm started to swell/ arm was so swollen that I couldn't put it down to my side) and PAIN IN EXTREMITY (arm is sore. I had it in my left arm/ really sore, hurts). On an unknown date, the patient experienced PYREXIA (fever), CHILLS (chills) and HEADACHE (headache). At the time of the report, PERIPHERAL SWELLING (underarm started to swell/ arm was so swollen that I couldn't put it down to my side), PAIN IN EXTREMITY (arm is sore. I had it in my left arm/ really sore, hurts), PYREXIA (fever), CHILLS (chills) and HEADACHE (headache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient stated that she doesn't know whether if it was lymph nodes or just swollen. Patient stated that on 22-Nov-2021, it was not hurting like it was and it was different from the first two injections that she got.   No relevant concomitant medications were reported. No treatment information was provided.; Sender's Comments: This case concerns a 50 year-old, female patient with no relevant medical history, who experienced the unexpected events of peripheral swelling and pain in extremity and expected events of pyrexia chills and headache. The events occurred after the third dose of mRNA-1273.  The rechallenge was not applicable as events occurred after third dose and no further dosing was reported or planned, based on information provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Shortly after receiving the vaccine, within about 5 minutes, patient complained of difficulty breathing and sweats. She was hyperventilating and taking shallow breaths. Her breaths started to even out a bit after a few more minutes, but her mother insisted on calling the paramedics in the event that this was an allergic reaction to the vaccine. The paramedics were called at around 3:31 and they arrived shortly after and assessed the patient. They determined that she did not need to be seen in an emergency room. Her mother said that she would bring her to the doctor to have her checked out to be sure.
Res found unresponsive lying in bed at 0735. No VS present. Res was last seen by nurse at 0720, in bed, moving, nurse told res was time to get up for breakfast and left room. Staff returned to room at 0735. 0737 CPR initiated; 0738 EMS called; 0741 EMS took over CPR, established IV, airway and suctioned ; 0750 Dr notified of situation;  0808 EMS pronounced res death per Dr.
With no prior known allergies or events of skin rashes, I broke out in hives a week after my Moderna booster shot. The shot went just like my other two COVID shots where my lymph node under the injected arm swelled up for 3-5 days and then went back to normal. At one week after my 3rd dose, I broke out in hives starting on my back and extending to all parts of my body (but focused in underarms, back of knees, elbows, etc). The hives did not respond to steroid injection, prednisone (60 mg/day for 4 days), or Benadryl (50 mg/4 hours, repeated for 1 week). They would appear and disappear within 20 minutes. Sometimes my hands and feet would swell to the point where I was uncomfortable wearing shoes or the gloves required at my job. I was able to get an appointment with an allergy specialist a week after the first outbreak and she said "sometimes hives just happen" and I started taking high dose Zyrtec which diminished, but not depleted, the hives. They still are present every day and are extremely itchy. Given that this is an unprecedented event, the fact that the hives often occur where my lymph nodes are located, and that peak immune response from the vaccine occurs a few weeks after administration, I still suspect that this is an immune response from the COVID booster shot.
received vaccines after a temperature excursion; This non-serious case was reported by a other health professional and described the occurrence of incorrect storage of drug in a 50-year-old patient who received Herpes zoster (Shingles vaccine) (batch number 7KG39) for prophylaxis.   On 11-JAN-2023, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced incorrect storage of drug (Verbatim: received vaccines after a temperature excursion). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK receipt date: 14-APR-2023 The reporter consented to follow-up. This case is for one of 119 patients, reported by same reporter. The patient received unstable vaccine after a temperature excursion, which led to incorrect storage of drug.; Sender's Comments:  US-GSK-US2023054677:same reporter US-GSK-US2023AMR055743:same reporter
suspected vaccination failure/I got shingles 2 months after getting the vaccine; shingles/I got shingles 2 months after getting the vaccine; 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.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 2 months after receiving 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.     Additional Information: GSK receipt date: 11-Jul-2022 Reporter's comment: The case was received from the patient via  interactive digital media. The patient sadly stated that he/she got the shingles 2 months after getting the vaccine. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Midnight after I received the 2nd dose of Shingrix I began to hurt all over my body. Woke me up in the night with the ache and pain in my back neck hips arms and even my scalp hurt. I could find no comfortable position and could not go back to sleep. The next day I continued to have a substantial amount of pain and discomfort. No appetite and generally just felt terrible. By 8 pm that next day I had a low grade fever and felt terrible. I went to bed early and with some help from Advil and Tylenol I slept. Woke today feeling better. Just so you know, I?m not a whiny person and I had absolutely no reaction to the first Shingrix shot!  Wish I would have never gotten the booster!  Can?t remember ever feeling that terrible!
Patient is complaining or sore arm with limited range of motion for more than one year after injection. She claims she has had treatment from her physician with no improvement.
Patient experienced tingling in arm, faintness, difficulty breathing immediately after vaccine administration. We had the patient lay down on the ground gave water. Patient experienced sweating and we gave him a cold compress to cool him down. At his request, we did not call for emergency help and epi administration was not necessary. Patient has a history of fear of needles and may think that it played a part in his reaction.
Information has been received from a neurologist concerning a 16 year old female patient who on an unspecified date, was vaccinated with a dose of GARDASIL (lot# not reported) at another health care providers' office. On 02-MAR-2010 the patient was admitted to hospital with severe headaches and increased fluid pressure in the head known as pseudotumor. 2 spinal taps were performed with pressure elevated both times. The patient was still in the hospital, and her pseudotumor persisted. The neurologist stated that the patient's mother was insisting pseudotumor was related to therapy with GARDASIL. Follow up information has been received from the neurologist concerning the patient who on 29-DEC-2009 was vaccinated with the first dose of GARDASIL. It was reported that the patient had a history of headaches prior to receiving GARDASIL and the complaint of headaches started on 30-DEC-2000. After the vaccination, the patient's headache became very severe. The patient also had a severe allergy (not specified) and the physician had "no idea if the patient's allergy was secondary to receiving GARDASIL. The patient had an appointment with the neurologist on 08-JAN-2010. On 01-MAR-2010, the patient was admitted to hospital. While in the hospital the patient had "two spinal taps to reduce the patient's fluid pressure" and was treated with steroid therapy. The patient was treated with another medication (name of medication not specified) and the patient had a severe reaction to the medication, which increased her fluid pressure. The neurologist stated that the patient was taken off all medications due to her reaction to the unspecified medication. The patient was discharged from the hospital on 06-MAR-2010 and had a scheduled follow-up appointment to see the neurologist. Additional information has been requested.
Could not raise arm due to severe pain.  Vomiting for 12 hours could not keep down water.  chills, high fever, abdominal pain 2 days, extreme fatigue, headache, muscle and leg weakness
On January 17,2022 had a fast heart rate known as Tachycardia. My heart rate was very high and I experienced chest pain. The next day my heart rate stayed high. I went to my doctor on January 19, 2022 had EKG, 2 week Holter monitor.
A report has been received from a Health Professional concerning a 62 year old, male subject, who had been receiving FLUMIST (Intranasal). FLUMIST (Intranasal) started on 02-Dec-2013. The patient who received FLUMIST is 62 years old. This was outside of the approved age indication for FLUMIST. The patient experienced PT who received FLUMIST is 62 years old. The outcome of the event of PT who received FLUMIST is 62 years old, is unknown. The report was considered to be non-serious by the reporter.
This case involves adult and unknown gender patient who got the flu (influenza) after receiving INFLUENZA VACCINE. It was unknown if the patient had any medical history, concomitant disease, or risk factor. The patient medical treatment(s), vaccination(s), concomitant medication, and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer [lot number and expiry date not reported] via an unknown route in unknown administration site for prophylactic vaccination. On an unknown date, the patient got the flu (influenza) (non-serious event) (unknown latency) following the administration of INFLUENZA VACCINE. It was unknown if there were laboratory data/results available. It was not reported if the patient received any corrective treatment for the event. At time of reporting, the outcome was unknown for the event got the flu. There will be no information available on the batch number for this case.
ACUTE ON CHRONIC RESPIRATORY FAILURE 10/21/2021 CHF EXACERBATION, UNSPECIFIED HYPOXIA 8/14/2021 CHF EXACERBATION, UNSPECIFIED
9JUN93 mom states pt had t103.4 on 8JUN93PM sleeping more than usual; 9JUN93 t97.1 ax 3cm redden area rt leg immun site; 30JUN93 sz activity;
I received my 2nd  booster shot on 03/02/2021 on the same day I  wasn't feeling good.  on  Thursday i went home and slept, i felt achy all over my body.  I slept all weekend , i  didn't eat like eating. On Monday i had a low grade fever. i had symptoms like COVID.  I didn't had any breathing issue.  I did a tele health she told me to take days off work.  i took Tylenol and Mucinex. i had headache.  I  had severe bronchitis, and breathing treatments later on. i was better after 1 week.
Grossly bloody stools within 48 hours of vaccines. Follow-up Information: Also received Rotateq vax on 10/11/06. 5 vaccines in total.
Information has been received from a medical assistant referring to a patient of unknown age and gender. Concurrent conditions and medical history of the patient were not reported. On 12-APR-2016 the patient was vaccinated with an expired dose of RECOMBIVAX HB (lot # J001836, expiration date: 01-FEB-2015) (dose and route unspecified). No adverse effects reported. Additional information has been requested.
Client indicated approx 1 hr s/p influenza vaccination on 11/18/04 her face became flushed, face felt hot. Temp normal. No itching or edema. Symptoms resolved within 3-4 hours.
Bleeding from roof of mouth starting 11/13/2001. Is on Coumadin daily. MD told pt that flu vaccine elevated PTT and INR.
Pale, clammy, dizzy.  BP 106/78. HR 88. O2 sat 98%. Laid on cot, drank juice.  At 1005, stated he is no longer dizzy and feels well.  Color pink.  Gait steady.
Trachialneuritis 2 hours to tetanus shot. Rt upper arm discomfort since 6/22/02. Physical exam on 10/5/02 revealed full ROM of Rt shoulder with discomfort on internal rotation. X-ray Rt shoulder neg. Seen by MD on 10/20/02.
Symptoms: 12 noon wheezing, SOB, Tachycardia, chest heaviness, coughing; feeling anxiety. 2 pm: All of the above - plus swelling of face, lips, mouth; increased tachycardia. Treatment: ED-IV SOLUMEDROL; BENADRYL; monitored cardiac status prescribed Prednisone for one week.
hot to the touch injection site; Itching around injection site; Redness from injection site to elbow; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itching around injection site), VACCINATION SITE ERYTHEMA (Redness from injection site to elbow) and VACCINATION SITE WARMTH (hot to the touch injection site) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Itching around injection site) and VACCINATION SITE ERYTHEMA (Redness from injection site to elbow). On an unknown date, the patient experienced VACCINATION SITE WARMTH (hot to the touch injection site). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form. At the time of the report, VACCINATION SITE PRURITUS (Itching around injection site), VACCINATION SITE ERYTHEMA (Redness from injection site to elbow) and VACCINATION SITE WARMTH (hot to the touch injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. Treatment details was included ice.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
covid vaccine breakthrough case  dose 1 Pfizer  1/30/21  EL9261 dose 2 Pfizer 2/20/21  EM9810 dose 3 Pfizer 11/4/21 no lot number dose 4 Pfizer 2/1/22 no lot number
A little over a day after 2nd shot the site became swollen, red, warm, itchy, and painful to move and to touch area. The 2nd and third days the area expanded to about 2-3 inches in diameter and continued to be red, warm, itchy, painful, and swollen. Day 4 the redness and swelling has decreased and itchiness is mostly gone. Still some discoloration and pain when touching/putting pressure on site remains.  Menses started the next day (5/7) but is probably unrelated. Also had a headache after 24 hours after shot for a couple hours.  Treatment consisted of Tylenol, ice, benedryl anti-itch ointment. Ibuprofen and Excedrin were also taken intermittently for menstrual cramps.
pt fainted & hit head very hard on hardwood floor p/vax;LOC for approx 20sec;when came to c/o h/a & nausea;C-spine immobilized & log rolled to side, very pale, ice pack to throat;VS taken, Bp 82/50, P108, R16;taken to hosp for eval;
RECEIVED JANSSEN VACCINE FROM HILL COUNTRY PERSONAL CARE HOME. DATE UNKNOWN. RECEIVED PFIZER DOSE ON 08/20/2021 FROM SAMHD.  UNKNOWN IF CLIENT RECEIVED A SECOND DOSE OF PFIZER TO COMPLETE SERIES.
headache - 8-11 beginning about 1:00 pm body aches - 8-10  beginning about 10:00 pm fever - 8-11  beginning at 11:30 am until 4:00 pm - Took Tylenol at 11:30  (highest temp was 100.5 then dropped to 99.5 about 4:00) lethargic - 8-11 beginning about 11:00 am until about 4:00 (I took a nap for 2 hours - unusual for me to nap more than 30 minutes.) arm pain at injection site - 8:10 beginning about 3:00 pm - Tylenol at 2:00 am - pain continues in arm - It is now 4:40 pm 8-11. nausea - 8-10 beginning about 10 pm and continuing to now - 4:40 pm 8-11
This spontaneous report was received from a certified medical assistant, referring to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapy were not provided. On an unknown date, the patients were vaccinated with improperly stored doses of PROQUAD injection (lot# M022401 expiration date 01-NOV-2017) for prophylaxis (strength, dose and route were not provided). It was reported that the vaccines were exposed to a temperature excursion between 5 and 14 Fahrenheit degrees for 63 hours. The call was placed because of a Digital data logger. No previous temperature excursion and no adverse symptoms were reported. This is one of several reports from the same source. Additional information has been requested.; Sender's Comments:  US-009507513-1702USA009056:
Temperature of 99.9°F.  Severe headache. Nausea. Lower half of body feels like its freezing and the top half feels like it is burning up. Every joint and body aches. Upper left arm muscles is weak.
This case was reported by a pharmacist and described the occurrence of drug dose administration interval too long in a patient who received TWINRIX. Previously administered products included TWINRIX (dose 1). On 18th December 2014, the patient received the 2nd dose of TWINRIX. On 18th December 2014, an unknown time after receiving TWINRIX, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. Pertinent medical history or drug allergies/drug reactions were not reported. On 19-SEP-2015, an expired sterile diluent (lot number reported as J006741; expiration date August 2015) (dose, frequency and route of administration were not reported) was used to reconstitute ZOSTAVAX (lot number, route of administration, dose and strength were not reported) and was inadvertently administered to a patient. No adverse effects were reported and no product quality complaint (PQC) was involved. Additional information is not expected because the reporter did not consent for new follow up attempts.
pt exp high temp w/in four hr of inj; high pitched scream; inconsolable cry 2 hr
Unmeasured fever, headache, redness/swelling, itching/burning at injection site.
Starting 8/4 early evening, low grade fever and chills, malaise. 8/5 still low grade fever less than 100 and malaise. 8/6 low grade fever less than 100 in the evening. 8/7 injections site and arm red and itchy, started BENADRYL, still fever in the evening. 8/8 injection site and arm red and itch, no fever present. Continuing to monitor.
On the evening following COVID-19 vaccine, patient had mild fever and experienced mild epigastric and bilateral upper quadrant pain.  Pain continued and patient presented to the ED on 1/31/2021 with  epigastric pain.  Final diagnosis appears to be acute diverticulitis with microperforation and early abscess formation.  No physician notes document that the two events are related; however timing is close.  Patient does not have a history of gallbladder disease, abdominal disease, etc.  Patient is currently admitted and followed by general surgeon.
PT OBTAINED A 3RD DOSE OF THE MODERNA VACCINE WITHOUT MEETING GUIDELINES THOUGH SHE SAID SHE DID.
Patient was 17 years and 10 months at the time of administration of vaccine.  No adverse side effects to date.
fainted twice within the first hour....   shaking first, clammy, 2nd time on the bathroom, felt it coming so laid down on the tile... diarhhea for an hour afterwards.  tired, scared.  alone.    confused.
Information has been received from a health professional concerning a 12 year old male with a history of rash for 2 days who on 19-SEP-2003 was vaccinated subcutaneously with the first dose of VARIVAX (Merck) (lot # 644974/0196N). On 21-JUN-2008 on exam the patient had scattered red papules on an erythematous flare over anterior neck, chest, abdomen and few on back and posterior thighs, over 80 lesions. The patient was treated with BENADRYL, every 6 hours, PRN, and AVEENO ANTI ITCH. The patient did not recover. No further information is available.
On 1/12/08 patient presented to the ER with seizure lasting 45 min.  Fever at the time before seizure started was 103.5 rectally.  CT scan was negative.  Chest x-ray was negative.  From the time of discharge 1/12/08 - 1/16/08 baby cried/screamed almost all the time.