chrisvoncsefalvay/vaers-outcomes huggingface dataset:
arm swelling; tongue swelling; nerve pain; joint pain; pain in the center of her back; trouble breathing; fibromyalgia; fever; This case was reported by a consumer via call center representative and described the occurrence of fever in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   In May 2022, the patient received the 1st dose of Shingrix (intramuscular). In May 2022, less than a week after receiving Shingrix, the patient experienced fever, swelling arm, swollen tongue, nerve pain, joint pain, back pain, difficulty breathing and fibromyalgia. The patient was treated with ambiguous medication nos (Neurontin (Nos)), epinephrine (Epi Pen) and benadryl (nos) (Benadryl). On an unknown date, the outcome of the fever, swollen tongue, nerve pain, joint pain, back pain and difficulty breathing were recovered/resolved and the outcome of the swelling arm was not recovered/not resolved and the outcome of the fibromyalgia was unknown.   It was unknown if the reporter considered the fever, swelling arm, swollen tongue, nerve pain, joint pain, back pain, difficulty breathing and fibromyalgia to be related to Shingrix.     Additional Information: GSK Receipt Date: 13-MAY-2022 Reporter's Comment: The patient self-reported this case. The patient received dose of Shingrix vaccine last week and experienced fever, arm swelling, tongue swelling, nerve and joint pain, pain in the center of her back and trouble breathing. The patient used Epi pen and Benadryl to treat her symptoms.  Fever resolved after 3 days and all other symptoms had also resolved except the swelling in her left arm which extends from an area right below the injection site to her elbow. The outcome of the fever, swollen tongue, nerve pain, joint pain, back pain and difficulty breathing were recovered/resolved in May 2022   The patient stated that she never had any reactions to other vaccines. The reporter did not consent to follow-up.
Patient states he had vaccination at 1030 today and did not want to wait the recommended observation time of 15 minutes in the hospital lobby.  He is currently a highway patrol officer. While driving in his patrol car, at 1035, he felt tightness in the back of his neck and tightness to his airway- he described it feeling like someone hit him in the neck. He denied having any trouble breathing. Later, he noted his hand was twitching. 1045, he came back to lobby and made an RN aware who brought him to employee health. He declined to go to ED (I found out later).  BP was 153/115 HR 102  initially, no hx of high bp.  No noted hives or swelling to face or mouth/tongue or L deltoid region.  Pt. denied feeling any itching anywhere.  Pt. rested for about 15 minutes on exam table. Re-check of BP was 151/113 HR 84.  Pt. states he feels better and feel like that feeling of tightness in his neck is decreasing.   Made aware to follow up with PCP regarding BP and giving informational handout regarding blood pressure.  RN recommended he go to any ED if he has any trouble breathing, swelling of tongue, etc at any time after he leaves this hospital. Pt. verbalized understanding.
Developed maculopapular, non-vesicular, non-petechial, non-ecchymotic, non-purpric, non-ulcerative predom on trunk, abdomen, back scatterd on legs, back of neck, very sporadic on palms and soles on 1-27-20
Patient woke up on 12/12/12 with a fever. At 9am temp was 101.8 degrees F, around 12:15pm it was 102.5 degrees. Also feels really tired and entire body hurts. Patient instructed to take NSAIDS for 24 hours and call back if no improvement or it worsens.
Patient was admitted for Multi drug resistant UTI (for which he has been admitted many times before). Was hospitalized for 3 days while awaiting cultures, hemodynamically stable, with no lab abnormalities. On the day of discharge (sensitivities to UTI came back, pt to be discharged on cefepime, had PICC line) pt got up from bed, sat on the edge of the bed and was being given belongings by the nurse, alert and oriented and in a pleasant mood, when suddenly pt grabbed at his chest and stated "I can't breathe" and became combative and altered when O2 was attempted to be placed on pt's face; then pt had PEA arrest x3 and unable to achieve ROSC.
This spontaneous report as received from a consumer (patient's adoptive mother), refers to a 9 year old male patient with ADHD, HPV, and allergic to penicillin. The patient's medical history included had tonsils taken out, papilloma surgery (every three months since 2007), papilloma and scraping the papilloma off of his vocal cords (every three months since 2007). On 05-SEP-2013 the patient was vaccinated with first dose of GARDASIL (dose unspecified) lot # /expiration: 0459AE 13-DEC-2014. The second dose of GARDASIL (dose unspecified) lot # /expiration: 1860AA 30-SEP-2014, was given on 06-SEP-2012 and the third dose of GARDASIL (dose unspecified) lot # /expiration H014645 27-MAR-2015, was given on 21-JAN-2013. Patient's concomitant medications were not reported. On an unknown date the patient experienced papilloma. On 12-NOV-2012 the patient experienced papilloma surgery (medically significant). The reporter stated that her son had to have surgery every three months since 2007 for scraping the papilloma off of his vocal cords. The reporter stated that the patient's last surgery for the papilloma was on 12-NOV-2012. Since then the patient has not had surgery for this because the papilloma had not grown back for the patient. The reporter stated that the patient every 3-6 months gets a scope down his throat just to make sure the papilloma was not growing back. The reporter thought that the papilloma had not grown back because the patient was receiving GARDASIL vaccine. The reporter reported that the patient was receiving the vaccine, even though the patient was diagnosed with HPV in 2007, to try and see what happens. The reporter also stated that the doctor who performed the papilloma surgeries for the patient had pictures before and after the papilloma surgeries if needed. The outcome of papilloma was reported as recovered/resolved. The outcome of papilloma surgery is unknown. The reporter's causality assessment was not provided. Upon internal review the event papilloma surgery was determined to be medically significant. Additional information has been requested.
Patient had vaccination at 3pm, developed blurred speech & confusion at 7pm. Patient was brought to hospital to rule out stroke by patient's daughter. Bloodwork found blood sugar was elevated (400), A1C was elevated (8) and blood pressure was high. Per patient's daughter, patient received a long acting injection of triamcinolone in her back which most likely contributed to her elevated blood sugar. MRA scan found patient had multiple mini strokes. Patient is still hospitalized as of 9/4/2020.
One hour after the vaccine patient became diaphoretic with headache and chills. Mom said breathing was abnormal. She gave him ibuprofen which helped. He slept it off.
01/15/2022, not long after washing my hair, I began to itch and that continued into 01/16/2022. I was itching head to toe, mostly in my arms, hands, and face. The itching continued for a few days, and I went to a local urgent care clinic on 01/23/2022, where they prescribed ZYRTEC. After beginning the medication, the itching got better. I followed up with a dermatologist who diagnosed Dermatographic Urticaria and explained that this condition can sometime occur after receiving a vaccine. They advised that I continue to take the ZYRTEC twice a day and that it may potentially get better. However, it's been a year now, and I still have to take the ZYRTEC daily.
Child received vaccinations and about 1 hour later began breaking out with hives and was taken to the ER. Mom states shild was given Claritin and has been doing okay not. Denies any respiratory problems. Mom states child has many allergies.
severe chills and shaking lasted about 4-5 hours; fever of 101-102 degrees; severe headache lasted about 8-10 hours; these symptoms started approximately 12 hours after vaccine received;
Huge swelling, huge lump that?s getting bigger, big purple bruise, redness all around the injection side, major pain can?t do anything with my arm, headache,fever,chills
Shortness of breath, chest pain 1 hour after shots were given. 5 hours after shots right side of face swells right arm and hand swells. 9 hours after shots whole right side of body numb weak and swollen not able to walk with out help.  4/25/08 Reviewed hospital medical records of 3/28-4/2/2008. FINAL DX: Lower extremity weakness.  Neuro consult stated probable conversion disorder.  ID consult stated probable Type 1 hypersensitivity reaction. Records reveal patient experienced sudden onset chest pain & SOB.  Did not resolve w/NSAIDS.  Awoke from sleep w/swelling right side face, weakness & numbness or right side, ambulating w/limp, HA, heavy feeling pain, fatigue.  Exam revealed droopy eyes, right arm/leg weakness w/dininished sensation, weak right hand grip.  Neuro, ID & cardio consults done.  Improved & d/c to home w/continued PT. Follow-up: August 13, 2008-Conversation with patient's mother. Patient is doing somewhat better. Can now walk without cane. Still some numbness-more tingly-"like feeling trying to come back". Still in physical therapy three times per week. Nerve conduction studies-normal. Patient's primary care physician has now been changed. (Since patient has not been in our office since March 28, 2008, more recent information could probably be obtained from Dr. Mother states that an egg allergy was noted in patient at an outing in May, 2008. After eating spinach dip which contained egg, she developed shortness of breath, chest pain, and weakness, which resembled her reaction after the immunizations. A similar reaction occurred later when she ingested eggs again. She has not been offered eggs since then. Patient's working diagnosis as of the time she was last seen in our office is a "probable Type I Hypersensitivity Reaction secondary to an immunization."
I began having seizures at night during sleep beginning on 3/23-3/24 overnight. They are simple partial seizures, but wake me up out of sleep. I currently have had 4 seizures all during sleep. I have a history of epilepsy, however I went years without seizures. I did have an occurrence of seizures in February however that was directly related to hormones associated with menstrual cycle.
Patient presented to the ED on 2/11/2021. She also presented to the ED on 2/13/2021 and was subsequently hospitalized.
4 days after receiving the vaccine, I started experiencing a loud whooshing sound in my right ear. It sounded like a waterfall tuned to my heart beat. The sound has changed from a whooshing sound to a humming sound but has stayed consistent and I have not been without that sound since it started. Its been over a week. I went to a primary care physician yesterday, on 5/5/21 8 days after the sound started. He sent me for a hearing test and an appt with an ENT. Today, the hearing test confirmed I have hearing loss in my right ear. The ENT doctor has prescribed prednisone for the next three weeks. I also have sensitivity on the right side of my face. My face feels like its tingling, especially around my right eye.
Onset approx. 6hrs post vaccine - Headache, Onset approx. 17hrs post vaccine - Flu like symptoms with chills, sweats, and muscle aches - lasted approx. 1 day.
20 - 30 minutes complex febrile seizure with signs of infection was noted 05/01/01. Hospitalization after extensive septic work-up and antibiotic administration. He also had a fever less than 102 at all times. Also diagnosed with hyperglygemia.
Shoulder pain that radiates from top of shoulder , under arm and on upper arm.  Popping sound at times. Swollen under arm.    Going for x-ray on 11-22-2022.
Vaccine was stored on refrigerator on 04-Nov-2021 and then administered on 09-NOV-2021; 606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine was stored on refrigerator on 04-Nov-2021 and then administered on 09-NOV-2021) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored on refrigerator on 04-Nov-2021 and then administered on 09-NOV-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine was stored on refrigerator on 04-Nov-2021 and then administered on 09-NOV-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication reported. On 04-Nov-2021, the vial was placed in the refrigerator. The vial did not have any temperature excursion and the patient had no adverse event. No Treatment medication reported.
Patient became short of breath when walking out to the car. He came back to the pharmacy and sat down. Reported being hot, short of breath, and having back pain for about 5 minutes. We alerted an ambulance, but the patient refused and stated he felt better after about 5 minutes of sitting with water and a cold cloth on the neck.
tested for antibodies and had no antibodies; This spontaneous case was reported by a consumer and describes the occurrence of ANTIBODY TEST NEGATIVE (tested for antibodies and had no antibodies) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 042L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, 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 experienced ANTIBODY TEST NEGATIVE (tested for antibodies and had no antibodies). At the time of the report, ANTIBODY TEST NEGATIVE (tested for antibodies and had no antibodies) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Apr-2021, Antibody test: had no antibodies (Negative) had no antibodies.         No concomitant medication was reported. The treatment information was unknown. Action taken with mRNA-1273 in response to the events were not applicable.
Palpitations, flushing, sweating. BP 190/120 (pulse 119), 210/88, 175/88. Sent to ED and cancelled second vaccine dose.
On 03-25-03, Day 12 post-vaccination, a non-naive vaccinee reported to the hospital site care monitor with a recent onset of a slightly itchy, red macular rash on the arm opposite from the smallpox vaccination site.  Within about one hour a red macular lesion was noted on the left forearm.  The vaccinee was referred to the ER physician for an employee health visit and was deferred from duty due to rash of unknown etiology.  The following day the vaccinee was again deferred from duty due to continued rash on arms and new onset of slightly itchy, red macular rash on abdomen.  The vaccinee reported a history of high fever on 03-23-03 and 03-24-03, with temperature maximum of 103.2 on 03-23-03. Also reported body aches, headache, and malaise during febrile episode.  On 03-27-03 vaccinee reported rash resolved following self-medication with Benadryl and was cleared to return to work.
Information has been received from a physician concerning a female patient who on approximately 26-JAN-2009 ("two months ago") was vaccinated with the first dose of GARDASIL. Subsequently the patient experienced injection site reaction. Last week the patient was vaccinated with the second dose of GARDASIL. The patient experienced viral syndrome with a fever and body aches since the second dose of vaccine was given. At the time of reporting, the patient's viral syndrome with a fever and body aches persisted. The patient sought medical attention via visiting office. Additional information has been requested.
Patient received the Covid-19 vaccine. She reports symptoms of Other: After receving the Moderna vaccine and arriving in the observation room patient stated she felt funny and lied down on the ground. She was diaphoretic and stating she heard ringing in her ears.   waved ammonia inhalant to which the patient waved away. She Stated " I am ok I think I was just having a panic attack. VS were obtained as follows: 1220: BP 105/67 HR 68 Sat 96% on RA 1222: BP 111/54 1225: 110/60 HR 79 Sat 97% on RA. At 1225 the patient sat up in chair, was given water and crackers, was Alert and oriented to person, place, and time and aware of the events that had occurred. The ringing was no longer present. Patient was reassured and observed for the remaining 30min with out incident. .
Patient reported feeling tightening in the throat about 5 minutes after sitting down to be monitored. She did not report difficulty breathing or other symptoms and she reported having a history of having this happening before so was not sure if she was having a reaction or just having an episode what she has had happen before. We monitored her for 15 more minutes and her husband asked us to call 911. she was breathing and awake but not very alert or responsive. When EMTs arrived she was checked out and they decided to bring her to the emergency department.
Within minutes of receiving the vaccine, the patient began complaining of difficulty breathing, chest tightness and coughing. After about 10 minutes or so patient instructed me to call 911. Paramedics came out to asses her. According to them her oxygen saturation was at 99%. Patient did request transport to the ER to be evaluated.
12 hours after shot: fever and chills with extreme shivering. Fever as high as 102.4, lasted 74 hours. Chills and nausea and generally felling sick lasted 5 more days after the fever broke.  Day 3 after shot: large red rash on arm at the site of the shot. Size about 3x4?. It was a little itchy on the first two days after it appeared. By day 8 it had faded.  Day 8 after the shot: new rash on each forearm. Size of each was about 3?x8?. Those rashes have faded, but still remain visible today. No pain or itching associated with the forearm rashes.
ON 5/9/19 PATIENT CALLED PHARMACY TO REPORT SWOLLEN ARM AT INJECTION SITE AND EAR RINGING
Following administration of Typhoid vax, pt exp shock-like allergic reaction characterized by: feeling ill, near fainting, & dec BP; pt hospitalized for 2 days;
1 of 5 pts who had a reaction following vax; pt exp a rash & numbness of the lips immediately following vax;
Massive blood clots right after Pfizer shot; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An elderly female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: THROMBOSIS (hospitalization, medically significant), outcome "unknown", described as "Massive blood clots right after Pfizer shot". The patient was hospitalized for thrombosis (hospitalization duration: 28 day(s)).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
PATIENT WAS GIVEN THE WRONG DOSE FOR 2ND VACCINE. SHE WAS GIVEN 0.25CC, OPPOSED TO THE FULL 0.5CC DOSE. PATIENT WAS MADE AWARE IMMEDIATELY BUT HAD ALREADY LEFT THE CLINIC. SHE WAS UNABLE TO RETURN SAME DAY DUE TO WORK COMMITMENTS. SHE HAD NO ADVERSE REACTIONS.
HPI: had headache, chest pain and nausea. Some of these symptoms began 1 months before this visit and have been unchanged since that time.  Has run a fever at home but did not check it.  He says his chest pain is always there.   He has not had pain radiate to neck or jaw or become sweaty.   Patient has tried zantac and omeprazole with no relief.. Lung mass, hyponatremia, thrombocytosis
This spontaneous report as received from a medical assistant refers to 5 patients of unknown age and gender. On an unknown date the patients were inadvertently vaccinated with an unspecified doses of VARIVAX (Merck) (route, lot number and expiration date not reported) that had been improperly stored. No adverse effects reported. Additional information has been requested.
Information has been received from a certified medical assistant concerning an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not provided. On unknown dates, the patients were vaccinated with VARIVAX (lot #: M040137 with expiration date: 28-SEP-2018) (dosage schedule, route of administration and anatomical location were not reported), for prophylaxis. The administered vaccines were improperly stored at a temperature of 8.8°F for 4 hours and 32 minutes, and at a temperature of 17.6°F for 4 hours and 29 minutes; this information was registered in a digital data logger. No previous temperature excursion and no adverse symptoms were reported. Additional information has been requested.
Two days after injection muscles in buttocks and upper arm ached.  Constant aching subsided after 3 days but still have pain in legs standing, no strength in hands and arms
This case was reported by a pharmacist via call center representative and described the occurrence of injection site discomfort in a 88-year-old female patient who received SHINGRIX (batch number ZY3X4, expiry date 28th April 2020). Concomitant products included Metoprolol succinate. On 27th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 27th April 2018, less than a day after receiving SHINGRIX, the patient experienced injection site discomfort. On 1st May 2018, the patient experienced muscle soreness and injected limb mobility decreased. On an unknown date, the outcome of the injection site discomfort, muscle soreness and injected limb mobility decreased were not recovered/not resolved. The reporter considered the injection site discomfort and muscle soreness to be probably related to SHINGRIX. It was unknown if the reporter considered the injected limb mobility decreased to be related to SHINGRIX. Additional details were reported as follows: The patient experienced mild arm discomfort at the injection site. Four days after receiving SHINGRIX, the patient developed a sore muscle and it was hard to lift her arm.