chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a physician via company representative refers to an 18 year old male patient. No pertinent medical history was reported. On 11-JUN-2015, the patient was vaccinated with first injection of GARDASIL 9. The next day on 12-JUN-2015, the patient felt tired, experienced symptoms of general malaise and headache. The patient sought medical attention. The patient had unspecified treatment by an unspecified infectious disease physician who recommended that he discontinue the GARDASIL 9 therapy. The patient was 18 years old which is outside the age range for indicated use of GARDASIL 9. No Product Quality Complaint (PQC) was involved. Action taken was not applicable. The outcome of events was unknown. The reporter did not provide the causality between the event and the suspect therapy. Additional information has been requested.
inging in ears (tinnitis) no stop since right after vaccine, horrible, unbearable saw ent given steroids nose sprays not working  -  was told by ENT he know of no other cases like this  also told pt no cure, and she has alot of angst about second vaccine
On 09/21/2001, pt received Hep B , 1st dose, IM in the left deltoid. Approximately 4 hours later, client "having trouble breathing" and "difficulty swallowing". Went to ER, X-rays taken showed swelling in throat, per mother. Rx given: Prednisone and Benadryl. No history of food or medicine allergies.
This case was reported by a consumer via call center representative and described the occurrence of migraine headache in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included ondansetron for migraine and promethazine for migraine. The patient's past medical history included migraine headache. Previously administered products included COVID vaccine with an associated reaction of chills (experienced headache chills, fever, nausea, vomiting and diarrhea after COVID vaccine but did not get hives). Concurrent medical conditions included adhesive tape allergy. On 6th December 2021, the patient received the 1st dose of Shingrix (intramuscular). In December 2021, the patient started ondansetron at an unknown dose and frequency and promethazine at an unknown dose and frequency. On 6th December 2021, less than an hour after receiving Shingrix, the patient experienced migraine headache, chills, fever, nausea, vomiting and diarrhea. On 7th December 2021, the patient experienced extremities hot feeling of and itchy upper limbs. On 8th December 2021, the patient experienced hives and fatigue. The action taken with ondansetron was unknown. The action taken with promethazine was unknown. On an unknown date, the outcome of the migraine headache, chills, fever, nausea, vomiting and diarrhea were recovered/resolved and the outcome of the extremities hot feeling of, itchy upper limbs, hives and fatigue were not recovered/not resolved. It was unknown if the reporter considered the migraine headache, chills, fever, nausea, vomiting, diarrhea, extremities hot feeling of, itchy upper limbs, hives and fatigue to be related to Shingrix. Additional details were provided as follows: The patient self reported this case. The patient had a history of migraines and is allergic to band-Aid adhesive. The reporter inquired about ingredients in SHINGRIX and stated she received her first dose of Shingrix and within 1 hour after receiving the vaccine, she experienced a headache (triggered a migraine), chills, fever, nausea, vomiting and diarrhea. The patient took ondansetron and promethazine for her migraine which helped her to sleep. On 7th December 2021, the patient noticed that her right arm was hot and itchy. On 8th December 2021, the patient noticed she had hives on her right arm, and that she was very tired, and her arm was still hot and itchy. The patient stated that she called her doctors office and that they are aware of her reaction to the vaccine. The patient stated that her experience with Shingrix was similar to COVID vaccine but did not get hives. The patient did not have dosing, lot, expiration date information of the vaccine. It was unknown if the reporter considered the migraine headache, chills, fever, nausea, vomiting, diarrhea, extremities hot feeling of, itchy upper limbs, hives and fatigue to be related to ondansetron and promethazine. The reporter consented to follow up. The patient consented to contact physicians Office.
Member complained of tingling, tickling sensation on her throat, denies difficulty breathing, itching nor swelling. Reported that this happened after the first dose as well. No shortness of breath, nor skin coloring change noted. Appears anxious. Able to swallow normally, tolerating water well. Physician onsite ordered Zyrtec. Cetirizine 10mg sublingual administered. Blood pressure elevated at 196/87, other vital signs stable. Patient reports forgetting to take labetalol today. Complained of headache 2/10. Throat symptoms resolved per patient. Headache improved 1/10. Patient observed for over 1 hour, BP rechecked often, did not decrease significantly. Transferred to ED for high BP.
localized redness bilat @ inject site-10 mins post inject; tx w/DPH elixir w/DPH; sz subsided w/in 30 mins of onset;
10-23-08 Pt received  Fluvax and PPV23 in RA -10-27-2008 seen for c/o 24 degree redness, swelling, tenderness @ injection site- recommend ice, diphenhydramine prn with effect.  Given PPV23 because only received 2 doses PCV7- History asthma-
Sudden onset of sharp pain and weakness in both legs within 10 minutes of vaccine. Experienced lean to the left when walking but strength had returned by this time. Sent to the ED for evaluation.  Pain gone by the time she got there. Lasted 30 minutes at most.
Very 'heavy' legs, extreme sore arm in first dose Extreme headache lasting around a week, chills, fatigue
flu like symptoms; pain in muscle arm area; coughing; pain from coughing in the upper left lung area; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 56-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On 5th October 2021, the patient received the 2nd dose of Shingrix. On 6th October 2021, 1 days after receiving Shingrix, the patient experienced influenza-like symptoms, pain in arm, cough and pulmonary pain. On an unknown date, the outcome of the influenza-like symptoms, pain in arm, cough and pulmonary pain were unknown.   It was unknown if the reporter considered the influenza-like symptoms, pain in arm, cough and pulmonary pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received dose of Shingrix vaccine and experienced flu like symptoms and pain in the muscle arm area, he developed pain from coughing in the upper left lung area. No further information reported.
Toes appeared bruised and painful upon touch. 15 minutes later, toes became inflamed and felt hot to touch. Also, experienced burning sensation.  10 minutes later, burning and erythema subsided and bruising reappeared. Bruises are still painful to touch, but both pain and appearance is improving since the event occurred.
no energy; slight fever; sore muscles; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 11Oct2021 11:45 (Lot number: FF8839) at the age of 74 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Known allergies: Sulfa" (unspecified if ongoing), notes: Known allergies : Penicillin and sulfa; "Known allergies : Penicillin" (unspecified if ongoing), notes: Known allergies : Penicillin and sulfa. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0151, Location of injection: Arm Left, Vaccine Administration Time: 09:30 AM), administration date: 07Apr2021, when the patient was 73 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EP7534, Location of injection: Arm Left, Vaccine Administration Time: 09:45 AM), administration date: 17Mar2021, when the patient was 73 years old, for COVID-19 Immunization. The following information was reported: ASTHENIA (non-serious) with onset 12Oct2021 07:00, outcome "recovered" (Oct2021), described as "no energy"; PYREXIA (non-serious) with onset 12Oct2021 07:00, outcome "recovered" (Oct2021), described as "slight fever"; MYALGIA (non-serious) with onset 12Oct2021 07:00, outcome "recovered" (Oct2021), described as "sore muscles". Therapeutic measures were not taken as a result of asthenia, pyrexia, myalgia.  Additional information: Vaccination facility: Public Health Clinic. No other vaccine in four weeks. No other medications in two weeks. No covid prior vaccination. Not tested for covid post vaccination.  No follow-up attempts are possible. No further information is expected.
REAL BAD MUSCLE ACHES; FATIGUE; FEVER; ACHY; This spontaneous report received from a patient concerned a 46 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 25-AUG-2021 00:30 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On AUG-2021, the patient experienced achy. Treatment medications included: paracetamol. On 25-AUG-2021, the patient experienced fatigue. On 25-AUG-2021, the patient experienced fever. On 26-AUG-2021, the patient experienced real bad muscle aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever, and real bad muscle aches, and had not recovered from fatigue, and achy. This report was non-serious.
Entire body started to itch the evening after the shot from head to toe, salmon colored hives on upper torso and arms.  States similar to when she received Enbrel for her rheumatoid arthritis.  No trouble breathing.
Case number PHEH2013US025091, is an initial spontaneous report from a consumer received on 02 Dec 2013. This report refers to a 24-year-old male patient. His medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: not provided) intramuscularly on 22 Nov 2013. On 24 Nov 2013, he experienced nausea, vomiting and developed bizarre behavior such as "staring at the door and stating that the hinges were working on the inside". He also experienced hallucinations and his mental status deteriorated further. On 26 Nov 2013, it was reported that he left his house barefoot stating that he "was trying to chase hobbits". He was hospitalized on the same day. On 30 Nov 2013, he was discharged from the hospital as his mental status returned to normal. The final outcome of the events bizarre behavior, hallucinations and mental status deteriorated was reported as complete recovery. The final outcome of the events nausea and vomiting was not reported. The causality was not reported.
4cm firm induration at injection site (left anterior thigh) with central area of deep erythema 2cm wide. Red, papular rash on trunk and upper extremities.
improperly stored vaccine administered after temperature excursion; This spontaneous report was received from a licensed practical nurse referring to a patient of unknown age or gender. No information regarding the patient's pertinent medical history, concomitant medication, previous drug reactions, or allergies was provided.  On 10-SEP-2021, the patient was vaccinated with improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot number 170746 has been verified to be valid, expiration date reported and validated as 14-MAR-2022) and haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (lot number T026961 has been verified to be valid, expiration date reported and validated as 02-APR-2023) for prophylaxis (administered dose, dose number, vaccination scheme, route of administration, and anatomical location of vaccination were unknown by the reporter) (product storage error).  On an unknown date, the vaccines experienced a temperature excursion of 48.7 degrees Fahrenheit for a time frame of 10 minutes. There wasn't a previous temperature excursion.
Site: Bruising at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Severe, Systemic: Allergic: Rash Generalized-Severe, Systemic: Abdominal Pain-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Chills-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Joint Pain-Medium, Systemic: Lymph Node Swelling-Medium, Systemic: Nausea-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Tingling (specify: facial area, extemities)-Severe, Systemic: Weakness-Medium, Additional Details: Patient came in pharmacy on 09/29/21 around 9am and shared with pharmacist he experienced severed bilateral arm pain, enlarged rash localized to arm site where vaccine was administered, neurologic pain , burning/ tingling of extermities, inflammation/swollen lymph nodes, and pericarditis symptoms. pharmacist instructed him to contact dr and share symptoms and adverse reaction to moderna vaccine given on sunday. He shared he would and would follow up. patient stated better feelin
Swollen, red, hot to touch, hard knot. Skin around injection site looks raw and dry.
Wednesday 08/27 began with 103.9 fever.  Next AM, redness noted left upper arm-08/28 redness, swelling high at midnight.  Diarrhea, hot, nausea, fever 102F-gave Benadryl for swelling, did not pack and use Motrin.  Being seen in office today 08/24/2003.
PATIENT HAS SWOLLEN, RED FACE, HEADACHE, INCREASE BLOOD PRESSURE, INCREASE HEART RATE, TROUBLE BREATHING AFTER 2 HOURS OF ADMINISTRATION OF VACCINE. PATIENT WENT TO THE ER AND GOT EPIPEN AND ORAL BENADRYL AND ORAL ATIVAN. PATIENT IS RECOVERING NOW.
After receiving my second COVID Vaccine. I stopped having periods; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 38 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in deltoid left, administration date 20Jan2021 15:00 (Lot number: EL9261) at the age of 38 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Depression" (ongoing); "ADHD" (ongoing); "Insomnia" (ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st Dose, Time: 16:00 , Anatomical site of injection: right deltoid, Route of administration: Intramuscular, Batch/Lot number: EJ1886), administration date: 29Dec2020, when the patient was 38 years old, for COVID-19 immunization. The following information was reported: AMENORRHOEA (non-serious), outcome "unknown", described as "After receiving my second COVID Vaccine. I stopped having periods". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient had 3rd Dose on 01Oct2021 around 10:30-11 AM, anatomical site of injection: left deltoid, route of administration: Intramuscular and batch/Lot number: 301458A. Specific relevant test for Thromboembolic events with Thrombocytopenia: None. In Jul/Aug2021, I was confirmed to be post-menopausal the age of 38. The patient was seen by PCP, OB-Gyn, and Endocrine, Endocrinologist diagnosed ovarian failure, autoimmune. I don't know that the 2 events are related, but the timing is of concern. The patient was not sure what additional testing or treatment she should seek. If you are doing any trials on this type of event, I would be willing to participate.  The Pfizer product had a possible casual effect to the adverse event.  Follow-up attempts are completed. No further information is expected.
Loss of taste; Loss of smell; She tastes burnt onion; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (Loss of taste), ANOSMIA (Loss of smell) and TASTE DISORDER (She tastes burnt onion) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007B21A and 013A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in November 2020.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Apr-2021, the patient experienced AGEUSIA (Loss of taste), ANOSMIA (Loss of smell) and TASTE DISORDER (She tastes burnt onion). At the time of the report, AGEUSIA (Loss of taste), ANOSMIA (Loss of smell) and TASTE DISORDER (She tastes burnt onion) outcome was unknown. Not Provided          Concomitant medication list was not provided. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not applicable.    This case was linked to MOD-2021-094912 (Patient Link).
Ringing in the ears.   No treatment as of yet.  I started to notice it a couple of days after the vaccine and it has continued till today, a total of 5 days.
This medically confirmed health authority report (initial receipt 16-Feb-2015) concerns a 25-year-old male patient. The patient had medical history of cerebral palsy and seizure disorder. On an unspecified date, the patient received influenza (seasonal) vaccine (manufacturer and batch number not reported). On an unspecified date, the patient experienced seizure. The outcome was not reported. Linked case: 2015048258 (same patient).
This spontaneous report as received from a pharmacist refers to a 59 year old male patient. On 18-JUL-2013 the patient was vaccinated with a dose of ZOSTAVAX (lot # J001700, exp date 08-MAY-2014) (0.65ml, once, subcutaneous route). Concomitant therapy was not reported. In July 2013, the patient experienced swelling of knees, the pharmacist was not aware when patient first experienced the adverse event and on 20-JUL-2013 the patient started MEDROL pack for swelling of knees. The patient stopped use of MEDROL on 21-JUL-2013 when patient became concerned, after reading unspecified information. The outcome of swelling of knees was unknown. Additional information has been requested.
MD NOTES: History of Present Illness Patient is a 66-year-old male with a history of chronic back pain who presents with altered mental status.  EMS was called to his hospital patient was unresponsive.  When they arrived, patient was unresponsive with sonorous respirations and pinpoint pupils.  Patient was given Narcan and then became awake and alert and was answering questions appropriately.  Patient initially refused but due to vital signs that the paramedics and they convinced him he needed to come here for evaluation.  Patient denies that he used any Norco or took any opiates whatsoever.  Patient states that he used to take Norco and fentanyl for his back pain but now he just takes Tylenol.  Patient denies using any IV drugs.  He is now complaining of this heart is racing and he is having slight midsternal chest pain.  He denies any shortness of breath.  He denies any headache.  He denies any nausea vomiting.  Denies any fevers or chills.  Patient states he might have been recently diagnosed with Covid. Re-evaluation Notes Reevaluation.  Vital signs stable.  Blood pressure is high but his heart rate came down into the 90s.  CT scan of the chest will be ordered since patient is Covid positive Fulford bilateral pneumonia  Reevaluation at 1952.  Vital signs stable but tachycardic again.  Patient's O2 sat is 91% on room air.  Will discuss with on-call Consultation :      Consultation Provided:   Physician.    Time Consulted/Discussed:  20:01    Notes:   Case was discussed.  Agrees with admission.  Recommends doing a CT angio of the chest as the patient is tachycardic and has Covid.  Patient should be admitted and recommends Silvadene on consult for ID
Temperature; Muscle aches; This case was reported by a consumer via call center representative and described the occurrence of fever in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fever and muscle pain. On an unknown date, the outcome of the fever and muscle pain were unknown.   It was unknown if the reporter considered the fever and muscle pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 03-JAN-2023 Reporter's Comment: The patient self-reported this case. The patient reported temperature and muscle aches with first dose of Shingrix. The patient stated that she was on her way to work and could not stay on the phone. The reporter did not consent to follow up.
When my heart rate goes low, I have Afib. The doctor has put me on Eliquis 5mg twice daily, which is a blood thinner. I usually do not feel the irregular heartbeat and the doctor said that is because it doesn't occur at a high heartbeat. It occurs when my heartbeat goes low. That first lowered heart rate occurred back when I had COVID about 23 months ago. Feb 2020. My heartbeat went very low. It has continued to be lower ever since having the COVID infection itself which occurred prior to vaccines themselves. So no vaccinations at the time I actually had COVID. I use to have a heart rate of about 60, when I had COVID it went all the way down to 30. Every now and then it will go down to the high 40s or low 50s, and it has the tendency to show that I have Afib on my smartphone, which is new for me. The Afib was diagnosed on 01/21/2022, which put me on that blood thinner. New Afib diagnosis recently, after 3rd vaccination. Not sure if it in relation to vaccination or not.
Within 5 minutes approx of receiving vaccines, pt's eyelids and cheeks were swollen, skin was flushed on ears, face, trunk. On Sat. 97-100%. Given oxygen by mask. Benadryl po, Prednisone po, Epi SC. Observed for 2 hours then discharged to home.
Patient came to me on 8/11/18 to show her arm. She said she started having inflammation reaction the night of vaccine, could not able to move her arm on the day of vaccine but as the days go by she said the inflammation moved from upper arm to below elbow and was able to move her arm when I met her. After seeing at her arm, I recommended her to either go ER as it looked like she developed cellulitis.
approx 5min p/vax pt was walking towards the door;pt stated couldn't see & begin swaying;pt lowered to floor by nurse;BP 80/50, vomited;aroused easily;later Bp 96/62;
Had my shot at noon on 4/19, and around midnight or shortly after (at 1am-ish on 4/20) I had really terrible chills and was shaking, but my forehead felt hot, I felt quite nauseous, and I had a headache. I got out of bed and took my temperature using a thermometer and it was 100.6 degrees. Continued to feel bad until falling asleep around 3am, woke back up at 6am and took my temperature again and it was still feverish at 99.8 degrees. Woke up once more briefly at 11am but did not take temperature and fell back asleep. Finally woke up for the day at 3pm and fever had broken, temp was back down to normal at 98.5. Still felt a little nauseous but that was probably more from not having eaten all day! Now as of 4/21 I am back to normal. (If it helps for further info, I have also not to my knowledge contracted Covid before, and I had no adverse effects other than a very sore arm from my first shot. The second shot my arm was less sore but of course I was distracted by being actually sick. Also possible data to note is that the second shot felt like it hurt less and I got an unusual new bandaid type the pharmacist called an inject safe barrier bandage.)
Red, swelling, 2 spots larger than a quarter, painful to lay on or touch.