chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report has received from a registered nurse via a company representative, referring to a 10 year old male patient. The patient had no medical history, concurrent conditions, drug, allergy history or concomitant medications to be reported. On 16-MAY-2018, the patient was vaccinated with GARDASIL 9 lot # N017686 in the right deltoid for prophylaxis (strength, dose, frequency, and expiration date were not provided). It was reported that on the same date, the patient also received BOOSTRIX in the same arm. Approximately 20 minutes after the patient received vaccination (on 16-MAY-2018), the patient fainted, and experienced seizure like activity, described as tonic clonic movements. It was reported that the patient received unspecified fluids and his heart rate and breathing were monitored as treatment for the events. On the same date, within 20 minutes after the onset of the event, the patient recovered from the generalised tonic-clonic seizure. The causality assessment between both vaccines and the event was not provided. Upon internal review, the events seizure like phenomena and tonic clonic movements were determined to be medically significant.
Dizziness started early afternoon and got worse thru evening, when nausea began.  At about 11:00 PM,  I vomited 4 times.  After that,  shaking chills set in.  I did not take anything for it.  When I woke up the next morning, I felt fine.
Systemic: Chills-Mild, Systemic: Ringing in ears, chills,then feeling flushes.  No obvious signs of diaphoresis-Medium, Systemic: Flushed / Sweating-Mild, Systemic: Headache-Mild, Systemic: Hypertension-Medium, Systemic: Tinnitus-Mild, Additional Details: Report. 20 min post admin, Aid ckd BP and reported 204/134. Rpt ringing in ears, chills, then warm sensation all over.  BP 5-10 min later in other arm, reported 213/162. Gave Pt water. COO at facility to call paramedics to assess.  Lied pt down for 5 min, rck BP 180/117.  Pt reported feeling fine w/ occasional chill. Waiting on Paramedics.  Approx 5 min, pt sat up complaining of headache. Paramedic arrived about 5 minutes later, assessed pt, bp 232/120?. To Hospital
Pt recvd 3 doses of Engerix-B, 3rd dose given 13JUL90 & it was determined that pt did not convert p/3 doses;
Patient received vaccine, then moved to a different room where he sat in a chair for blood work to be drawn. The vaccine was given at approximately 10:52am, and then he had his blood drawn and began to feel ill at approximately 11:05am.  He was pre-syncopal, bradycardic and hypotensive as he was also pale, and had slowed speech. Patients vital signs were obtained, along with a glucose check, was given juice, and an ice pack. Nurses were instructed to call EMS. Patient then laid on a bed, vitals improved. Was then transported to the hospital for further care.
Systemic: Abdominal Pain-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Mild, Systemic: Hyperventilation-Mild, Systemic: Nausea-Severe, Systemic: Shakiness-Mild, Systemic: Vomiting-Medium, Systemic: Weakness-Mild, Additional Details: The first side effects of nausea and vomiting were reporting a few minutes after vaccination.The patient then reported some dizziness/lightheadness.Upon checking back,they changed their original report of dizziness/lightheadness to also include possible fainting.Blood pressure measurement was attempted 3 times with 2 different cuffs,but an error was displayed.It was sucessfully tested on a collaegue.EMS noted BP 120/81.Patient was coherent and conscious,albeit nervous,while conversing.
I went to urgent care in June 2021 because of hives . The hives go away and return other places on my body.
Initial information received on 28-Aug-2018 regarding an unsolicited valid non-serious case received from Other health care professional (office manager). This case involves a 70 years old female patient who experienced itching, redness and swelling way below the injection site, while she received vaccine ADACEL. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient did not receive any concomitant medication. On 24-Aug-2018, the patient received a 0.5 ml dose of suspect DIPHTHERIA-2, TETANUS, 5 AC PERTUSSIS VACCINE (lot no U5875AB Exp. date 14 Feb 2020) via unknown route in the left deltoid. On 25-Aug-2018, the patient developed a non-serious itching one days following the administration of DIPHTHERIA-2, TETANUS, 5 AC PERTUSSIS VACCINE. On 25-Aug-2018, the patient developed a non-serious redness and swelling way below the injection site one day following the administration of DIPHTHERIA-2, TETANUS, 5 AC PERTUSSIS VACCINE. The patient returned to office on 27 Aug 2018, and at that time, the redness, itching and swelling were noted to be way below the injection site. The patient is not able to say if symptoms began at injection site. (Other relevant tests included no lab data). Final diagnosis was itching, redness and swelling way below the injection site. The patient did not receive any corrective treatment. The patient outcome is reported as not recovered for itching, for redness and swelling way below the injection site. List of documents held by sender - none.
Information has been received from a registered nurse referring to an unknown number of patients of unknown age and gender. Concurrent conditions and medical history of the patients were not reported. On unknown dates, the patients were vaccinated with doses of VAQTA (lot # L013380, expiry date: 04-NOV-2017) (lot # L022259, expiry date: 06-APR-2017) (dose and route unspecified), which had been improperly stored under 10 degree centigrade for 72 hours, and later under 1 degree centigrade for 8 hours. Other suspect and concomitant therapies were not reported. This is one of several reports received from same source. Additional information has been requested.
Lillian felt nauseated at 10:52am after receiving the Pfizer vaccination, dose 1 at 10:45am.  We took her blood pressure, it was 138/72. She was given some electrolyte fluids and she  felt better. Her blood pressure repeat was 182/86 at 11:00am. She voiced that is normal for her and that she takes medication for high BP. She disclosed no other medical history to us. She did voice that she did not eat that morning or take her medication. After feeling better she was escorted to her car and her family member drove her home.
Headache, (the following symptoms were fairly intense) chills, sweats, pain at injection site, muscle aches, fatigue, shortness of breath, nausea
Information has been received from a physician concerning an 11 year old male who at one year of age, in 1995, was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). In December 2005, the patient experienced a mild case of chickenpox. Unspecified medical attention was sought. No Product quality complaint was involved. Additional information has been requested.
A week after the COVID vaccine, I experienced muffled ear pain and ringing in my ears. Then a week later I felt chest pain, heart rate at rest was 130's-140's. Went to the ER and Troponin levels were elevated. I was diagnosed with Myocarditis, of unknown cause since all my respiratory panels were negative, all my labs do not point to any cause except that I received the COVID vaccine.
Information has been received on 06-JUN-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. In September 2012, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route by a physician as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. In July 2016, the patient was treated by a physician for a blistering vesicular outbreak, which was diagnosed as a herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient has suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
This case was reported by a nurse via other manufacturer and described the occurrence of crying in a 2-month-old female patient who received DTPa (DTaP vaccine) for prophylaxis. The patient had a Family History of allergy (seasonal), asthma, hypertension, cancer and seizure. On 12th January 2000, the patient received DTaP vaccine. On an unknown date, less than a year after receiving DTaP vaccine, the patient experienced crying and screaming. On an unknown date, the outcome of the crying and screaming were unknown. It was unknown if the reporter considered the crying and screaming to be related to DTaP vaccine. Additional details were deceived as follows: In 2013, mild persistent asthma. Recently the patient received the TRUMENBA. The patient presented with body aches, pain up to her shoulder. The patient also received some drugs on 11th September 18, the patient had Flovent 44 mcg inhaler for asthma 2 puffs BID, 2 puffs q 4 prn cough, wheeze , chest tightness, Albuterol MDI  and Ibuprofen oral.
Health Department informed us of a excursion with our refrigerator and deemed our vaccine nonviable
Initially a little tingle down the arm into the fingers which went away and then about 2 hours later my arm/shoulder area was sore and by bed time my arm/shoulder was hurting pretty bad.  12 hours after the shot I could hardly move my arm.  This went on for 2 days and on the 3rd day I was able to move my arm but still had some pain.  Day 4 was much better.  On 3/4 I was doing some yard work and by the evening my arm/shoulder area was again very painful and I'm not able to raise my arm again.  This is day 2 and I'm still having pain and not able to raise my arm above the shoulder.  There is tenderness over the injection site.
This spontaneous report as received from a pharmacist refers to a newborn male patient of unknown age. On 10-NOV-2012 at 19:50, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Drooping of left cheek; Elevated blood pressure; nodes in neck enlarged; sore to touch; headache; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9261, expiration date was not reported), via an unspecified route of administration on 28Jan2021 09:45 at single dose for COVID-19 immunization. Medical history included allergies and known allergies to sulfa drugs. Patient was not pregnant at the time of vaccination. Concomitant medication included ascorbic acid, betacarotene, cupric oxide, tocopheryl acetate, zinc oxide (PRESERVISION), iron, colecalciferol (VITAMIN D), acetylsalicylic acid (ASPIRIN). The patient previously took first dose of bnt162b2 on 07Jan2021 09:45 on the left arm for COVID-19 immunization. The patient experienced elevated blood pressure, all nodes in neck enlarged and sore to touch, drooping of left cheek and headache on 29Jan2021 22:00. Condition persisted for 4 days. The patient received an unspecified treatment. The patient had a visit to the doctor and emergency room. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. The patient was recovering from the events at the time of the report.
This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a adult female patient who received SHINGRIX (batch number 9277N, expiry date 27th June 2021) for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX (subcutaneous). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm and intramuscular formulation administered by other route. On an unknown date, the outcome of the pain in arm and intramuscular formulation administered by other route were unknown. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. SHINGRIX was inadvertently administered subcutaneously, which led to incorrect route of vaccination. The patient returned to the pharmacy because her arm hurt. The reporter consented to follow up.
Starting Wed eve of the vaccine shot, my husband could not sleep; the next day he was very weak and could not get up. I had to feed him in bed (usually he can get up and feed himself at the table). He was also incontinent. This is Saturday and he is till weak but can sit up and eat. He is still having trouble with urine control. If this continues, we will see the doctor this next week.
fatigue; fever/fever 100.2; Light-headed; headache; This is a spontaneous report from a contactable consumer or other non hcp.  A 67-year-old male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration on 12Feb2021 (Batch/Lot Number: EL9267) as dose 2, single (at the age of 67 years old) for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 for COVID-19 immunisation and experienced after the first dose of the vaccine, 3 days after experienced fatigue and dizziness. And was on the sofa all day. The dizziness and fatigue lasted on and off for 2 days but not the same degree.  The patient stated on 22Feb2021, "The dizziness and fatigue lasted on and off for 2 days but not the same degree. The 2nd dose was very uneventful. But had some reaction yesterday which is 10 days after having the 2nd dose, little fever and very fatigued and better today. Is there any reports of delayed reactions, 9 or 10 days after?"  The patient underwent lab tests and procedures which included body temperature: 100.2 on 22Feb2021 and normal on an unspecified date.  The outcome of fatigue and fever was recovering and other events was unknown.   No follow-up attempts are possible. No further information is expected.
Large redness, swelling at site of inj. Noticed day 2 after receiving vaccine. Increased swelling, redness day three. TYL or MOTRIN prn.
Light-headed and dizzy, feeling like I would pass out.  Within an hour of getting the vaccine call 911 after pulling over in my vehicle.  Next day, still having the same symptoms visited ER. Symptoms occur many times a day and I am concerned for my long-term health.  Diagnosed as "Vasovagal Syncope" by cardiologist.
p/vax pt devel inj site rxn characterized by red; painful; swollen area described as cellulitis;seen by MD; no tx
arm problems; Incomplete course of vaccination; This case was reported by a pharmacist via call center representative and described the occurrence of musculoskeletal discomfort in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 31st October 2019, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 9 months after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced musculoskeletal discomfort and incomplete course of vaccination. On an unknown date, the outcome of the musculoskeletal discomfort and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the musculoskeletal discomfort to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received Shingrix and had musculoskeletal discomfort. The pharmacist denied any additional information about the patient. The reporter did not consent to follow up. The reporter was transferred to medical information for additional assistance regarding the Shingrix vaccine and additional data GSK might had. The patient and has not received a second dose yet, which led to incomplete course of vaccination. This case US2020096487 is a duplicate of US2020096485. All future correspondence will be submitted to US2020096485.
Weakness; Sore arm; Body aches , pain everywhere; Headache; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weakness), PAIN IN EXTREMITY (Sore arm), PAIN (Body aches , pain everywhere), HEADACHE (Headache) and NAUSEA (Nausea) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A.) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ASTHENIA (Weakness), PAIN IN EXTREMITY (Sore arm), PAIN (Body aches , pain everywhere), HEADACHE (Headache) and NAUSEA (Nausea). At the time of the report, ASTHENIA (Weakness), PAIN IN EXTREMITY (Sore arm), PAIN (Body aches , pain everywhere), HEADACHE (Headache) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported  No treatment information was provided.
Patient came back to the pharmacy on 10/10/17 complaining of severe shoulder pain on both sides, and neck pain. Advised patient to use ice/heat and take acetaminophen for pain, and see MD if symptoms did not improve. Patient saw his MD on 10/11/17, and was prescribed cyclobenzaprine 10mg, amoxicillin 500mg, and prednisone 10mg. MD told patient it may have been caused by getting 2 injections at one time.
Dad called stated pt had been screaming about 20 min, inconsolably then became limp & dazed; parents denied any sz activity; pt would focus & follow w/eyes; parents asked to bring pt to be seen; pt recovered while getting in car;
1:02 pm-Patient came into Covid Observation Area after reporting diffuse itching to arms, chest, back and legs immediately after receiving 2nd dose Pfizer vaccination, actively scratching and appears uncomfortable.  Denies any difficulty breathing. No noted swelling to face, lips or tongue. Alert and oriented x 3, speaking in complete sentences. Patient reports experiencing itching and hives after 1st dose Pfizer vaccination. States she was given Benadryl 25 mg and observed for 1 hour after 1st dose. Also states she took Zyrtec one tablet this morning at 11:15 am to help prevent itching. States itching is not as bad as it was after 1st dose and no visible hives or rash, but noted redness and scratch marks to back, chest and arms. Also states she was cleared by her Allergist to receive her 2nd dose Pfizer vaccination today.  1:03 pm- VS-Temp 96.9, BP 182/85, HR 104, RR 20, 02 SATs 99% RA  1:05 pm- Call placed to on call provider, informed of patient symptoms above. Per Dr., give Benadryl 25 mg x 1 orally and continue to observe patient for additional 30 minutes. Verbal order repeated and confirmed.   1:07 pm- Benadryl 25 mg orally x 1 given as ordered.  1:25 pm- Patient reports feeling dryness in throat. Denies any difficulty swallowing or speaking. Denies throat tightness or throat closing. 02 sats 95% RA. Informed patient that dryness likely side effect of the Zyrtec and the Benadryl. Provided additional water and juice. Will continue to monitor.  1:27 pm- VS: BP 183/117. HR 95, RR 20, 02 SATs 95% RA  1:34 pm-VS: BP 150/84, HR 89, RR 20, 02 SATs 100% RA- Patient reports decreased itching and states dryness in throat resolving. Redness and scratch marks to back also clearing.   1:46 pm- VS: BP 157/76, HR 90, RR 20, 02 SATs 99% RA- Patient states she feels much better, throat dryness improved, scratching less.   2:07 pm- Discharged home in stable condition, accompanied by her 17 year old daughter who will drive home. Advised to seek Emergent care or call 911 if worsening symptoms return or if she experiences any throat tightness or difficulty breathing. Patient verbalized understanding.
12:00 PM started feeling sick and weak. 2:00 PM I laid down for a nap and when I got up I was weak, dizzy & nauseated. I had to lay flat on the floor with my cell phone in my hand in case I had to call 911. I laid there about an hour. 3:00 PM - The rest of the afternoon I did not do much, I felt like I was coming down with something. I felt if I got worse I would have to go to the hospital. Then by evening I felt better and was able to eat and by 8:00 PM that night I was feeling better. The next day I felt I was getting over an illness, since then I have not had any other symptoms. I am apprehensive about getting another vaccine next year.
Pain, paresthesia, cold, erythema,  splotchy, edema on Left arm/elbow (Note:IM site on Right Arm); tongue edema, tongue & lip paresthesia
Fever, bodily discomfort, chills, burning eyes, nausea. Cold towels were placed to lower his fever.
1st vax, 3/9/21, right arm, nausea, threw up 1st day 1x, super soar arm 5 days, stayed in bed 3 days, 2nd shot 4/5/21 left arm (cuz i norm sleep on R arm so switched), sluggish for couple days, nausea for a wk, rested for approx 1 wk. 3rd (booster) 11/16/21, left arm again, slightly sluggish 2 days. All shots same store, same Moderna. approx 2 1/2 wks after booster my right arm started to feel super sore where i got my 1st shot 7 mths earlier. Occasionally hurts in the exact spot where i had the 1st shot (keep in mind 2nd and 3rd shot were in left arm) but after booster my right arm has had so much pain I can't lift it. I use heating pad on upper arm and shoulder but only helps the pain while i'm using it. this is not the most user friendly form.. now on 6th attempt to fill out what i can. I don't have insurance, i have various allergies from medic medication like aspirin, a few other i literally can't remember (reactions i had when young).. now i have food allergies and mouth tongue allergies i won't go into. point is i felt it was necessary to fill out this form because i have so much pain in my right arm, now my whole  body.. i don't know what to do. I only get $500 that just started. i haven't found work yet, and don't know if physically i can go bk to work.. i'm in so much physical pain i can barely walk.. right arm is imbarable pain.. and this all started about 2 1/2 wks AFTER my booser in the other arm.. I haven't had a shot in right arm since 1st vax back in March '21.  this is insanely odd. btw, left arm doesn't hurt at all.. all pain is in right arm above elbow and partially into my shoulder..  btw, i used to walk 5 miles a day..   Now I can't walk more than 2/10ths of a mile without having to turn around and come home.  I won't get a 4th shot if offered obviously. I felt it necessary to let you know about this strange reaction after the booster, which i'm aware, was only half a dose.   I don't know what to do. this pain is completely dibilitating.. (sp).. this page has such a light colored font on grey bk ground i can't even see what i'm tyiping so excuse typos..   I hope someone gets this.. if anyone wants further contact use my email
Fever (Tmax 102), pain at site of injection, erythema at site of injection.