chrisvoncsefalvay/vaers-outcomes huggingface dataset:
feel chills; difficulty breathing; This case was reported by a pharmacist via call center representative and described the occurrence of chills in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th November 2019, the patient received the 1st dose of Shingrix (intramuscular). In November 2019, 10 hrs after receiving Shingrix, the patient experienced chills and difficulty breathing. On an unknown date, the outcome of the chills and difficulty breathing were recovered/resolved.   It was unknown if the reporter considered the chills and difficulty breathing to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient received Shingrix and about 10 hours later the patient started to feel chills and was having difficulty breathing.  The patient was okay. No additional information was provided.
Within minutes of getting the vaccine (1st dose), I could feel my face flushing. I went to the nurse's station and showed them my face.  I felt dizzy.  They took my blood pressure and 167/128.  They gave me 2 doses of Benadryl and kept monitoring my blood pressure.  After 45 minutes and a 3rd dose of Benadryl, my systolic number went down to 97.   After 3 hours my blood pressure stabilized to normal numbers.
I have got erectile dysfunction from the pfizer vaccine I feel less sensitive with a burning tingle feeling . I have found many other with this problem who went to doctor but could not help with this problem all they said was time that help them recouver it been almost 4.5 month for me and still suffer from this problem.
13 yo male patient received Pfizer Omicron Bivalent Booster and Flucelvax flu vaccine at 1345. Patient stated he started feeling weird after receiving the Pfizer Bivalent booster. The provider on site was alerted. Patient reported shortness of breath. The provider gave the patient Benadryl oral suspension 50 mg at 1350. at 1401, his blood pressure was 106/68, right arm manual blood pressure. His heart rate was 96 and O2 sat was 94% on room air. The patient denied swelling in his mouth but reported feeling drowsy. He denied dizziness and denied shortness of breath upon standing. His mother was notified and arranged for the patient to be picked up from school. Patient was cleared by the provider and released ambulatory to his family at 1405.
Patient was administered the 1st dose of the Pfizer Covid-19 vaccine, approximately 5-7 minutes after the dose he reported dizziness, loss of vision, and trouble breathing. No signs of a rash or hives. Parents were asked if Epi-pen could be administered. Parents refused administration of Epi-pen. Patient was told to sit down and given water along with Benadryl (25mg, 2 tabs). After 5 minutes still reported no improvement and trouble breathing, 911 was called and paramedics were called on site. Patient was observed for 15-20 minutes, at which point he reported feeling completely fine. No trouble breathing/swallowing, and  no dizziness reported. Patient declined any medical transport, and went home with parents.
Site: Pain at Injection Site-Medium, Site: Swelling at Injection Site-Mild, Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Body Aches Generalized-Medium, Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fever-Mild, Systemic: Joint Pain-Medium, Systemic: Lymph Node Swelling-Mild, Systemic: Nausea-Mild, Systemic: Tinnitus-Severe, Systemic: Unable to Sleep-Medium, Additional Details: -Dizziness occured 3 minutes after vaccination. At first this was a frequent occurence and now it happens sometimes (rarely). -Ring in my ears - Consistent; stronger as the day goes by. Results in me being very tired. ENT has confirmed slight hearing loss and tinnitus. He has classified this as permanent damage.
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medications. The patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) on or about 13-DEC-2012, as recommended for routine adult health maintenance and for the prevention of shingles. ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of shingles. On or about 21-FEB-2016, the patient was treated at a clinic for the onset of a blistery rash accompanied by weakened immune symptoms, which tested positive for varicella-zoster, indicating a current zoster infection. As a direct and proximate result of these malfunctions, the patient has suffered and will continue to suffer significant medical expenses, lost wages, pain and suffering, and other damages. Additional information has been requested.
17SEP91 AM attended for OM recheck; found to be healthy; hx hdyrocephalus, convuls disorder, failure to thrive; Pt recvd MMR/HIB per MD order mom gave APAP @ home; pt exp rt extremity sz starting 20SEP91; Seen by MD admitted to Hosp;
Patient with injection site reaction, left arm, treated with ibuprofen and Benadryl, discharged with Norco and to ice area.
I was very sick with Covid-19 for six weeks starting the week of holiday 2020. I was very dizzy and fatigued. After each dose of the vaccine I was very sick after each one. I also experienced feelings of dizziness and disorientation for up to ten days. I did not feel confident to drive. I have also experienced Arthritis pain especially in my hands and feet. I developed Neuromas on the bottom of my feet. I have constant chronic pain now that I had not noticed before getting the vaccines. After the first dose of the vaccine I got hives and visited the ER. I was given Steroids for two weeks. I had hives on my arms and upper back. They were extremely itchy and they were little dots. The Steroids helped after about three days. I had the same week of extreme sickness and Arthritic pain and swelling after the following two doses of the vaccine. After the second dose of the vaccine I got Thrush in my mouth and I had all the same symptoms for a week after the shot. I did not get any hives after the second or third doses. It has been eight months since my first dose of the vaccine but my hands and feet are still painful. The Arthritis flared up after each of the next two doses of the vaccine.
Received expired second dose; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired second dose) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006C21A and 008C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired second dose). On 19-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Received expired second dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.   This case was linked to MOD-2021-357526, MOD-2021-357788, MOD-2021-357978, MOD-2021-357980, MOD-2021-358415 (Patient Link).
An extra flu vaccine was given to this patient today. He had a previous flu vaccine this season on 9/11/2023. He suffered no side effects from this extra flu vaccine
Pt experienced swelling and redness at injection site of left thigh. Onset the following morning. Warm to touch. No fever was noted. Bumpy at site and dependent knee. Child is playful, no irritability.
Sunday:  About 5 hours after the injection, I started to get a dull headache.  The site of the injection on the right arm started to  feel tender and sore.  Two symptoms that were not too bad at that point.  Then, throughtout the night, the headache got worse.  By the morning (Monday), I had a splitting headache--it felt like my head was in a vise.  I was very sensitive to light and was nauseous.  I slept off and on and only drank water and had a bowl of oatmeal.   As Monday progressed, they nausea went away.  On Tuesday, I felt better.  I was able to eat, got to the gym and do a Cardio class, and then a 45 min. walk.  I felt 100%.  However, on Wednesday, My whole left side of my head and face was very sensitive to touch.  ALSO, I developed a cold sore on my right nostril, outside near the mouth, and also on my right upper lip.   All day Thursday, the right side of my head and face was sore to the touch.   As stated, this is the 2nd dosage of the shot.  The first of the series was given in October (I did not report this) and I developed pain in my right eye and a cold sore on my right lip.  I attribute the cold sores in both cases to be related to the shots and  I do not see them listed as a side effect on any reading materials given to me.
Information has been received from a physician concerning a 6 year old male patient who on 15-OCT-2004 and 12-NOV-2007 was vaccinated with the first dose (lot# 648032/1157N) and second dose (lot# 658408/1177U) of VARIVAX (Merck). On 09-MAR-2010 the patient was diagnosed with the chickenpox and was given ZOVIRAX (manufacturer unspecified). The patient sought unspecified medical attention. No laboratory diagnostic studies were performed. The patient recovered from chickenpox on an unspecified date. Additional information has been requested.
Highest temp measured 100 R, rash other than @ inject site, 4 hrs anaphylaxis, hives;
Information has been received from a physician concerning a 3 yr old female who at one year of age, in 2003, was vaccinated with a dose of varicella virus vaccine live. In Dec 2005, the pt experienced a severe case of chickenpox. Unspecified medical attention was sought. No product quality complaint was involved. Additional information is not expected.
PATIENT HAD VACCINES ON 04/22/08 AND PATIENT WOKE UP WITH A RASH ON 05/02/08.
Patient came back to office with rash on right leg for 12 days per mother.  15 cm x 6 cm (hive like lesion).  Erythematous.
ZOSTAVAX was administered on 6/9/09.  Pt got a fever on 6/10 and then a shingles rash on 6/21.  She was diagnosed with shingles on 6/24/09.
11-3-10 seizure at 3 pm. Seen by primary care physician - admitted to hospital seizure plus high pitch cry x 2 days. Cry would stop when held or fed. EEG - normal, spinal tap - negative for meningitis. No Rx prescribed for seizures. Mother stated child is "less fussy since taking off milk - still has some shaking when he becomes to warm or tired".
Pt received DTP shot at approx. 15:00 on 9/7/00. He started screaming uncontrollably at approx. 18:30. Gave Tylenol every 4-6 hours for approx. 24 hours.
He starting running a fever on November 16th, that night he woke up screaming several times, his eyes were all glazed over, and he was petrified. I thought they were just nightmares. The morning of November 18th, he was taken by ambulance to the hospital following a grand mal seizure. He went on to have multiple seizures at the hospital, and was transferred to another facility. At first they were calling them febrile seizures until they diagnosed him with epilepsy. The cause of his fever is still unknown, but I believe the vaccines he had on Nov.9 may have caused the fever, and brought on the seizures.
patient passed out for a few seconds minutes after receiving first pfizer vaccine.  paramedics were called onto scene.  pt was observed until pt recovered
Patient reports that there was redness of the injection site, radius of 2 inches. circular. Also itchy and hot at the site. Patient reports that reaction began after injection and lasted greater than 3 days.
The patient had immediate dyspnea and dizziness.  When there was no immediate resolution, she was taken to the ER on campus.  She was released home following ER evaluation.
Patient received COVID-19 vaccine on 1/11/2021 at  1538p per vaccine documentation. On 1/11/2021 at 1607p, Patient complained of having itching and hand burning. Patient was administered PO Benadryl 50mg at 1607p. At 1617p, patient complained of increased shortness of breath and audible wheezing. Patient was administered Epi 0.3mg IM herself and verbalized relief 2 minutes after Epi was administered. Patient was transferred to Hospital's ER for further evaluation. Patient was prescribed Benadryl 25mg, Pepcid 20mg, Singulair 10mg, and Prednisone 20mg by the ER.
Severe redness and large hard bump developed into cellulitis over the weekend of 12/10/22
Itching and bottom swollen after COVID vaccine; Itching and bottom swollen after COVID vaccine; Extreme pain; Vomiting; Gall bladder not working; Impaired speech; Itching all over body; Swelling on face; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching and bottom swollen after COVID vaccine), SWELLING (Itching and bottom swollen after COVID vaccine), SPEECH DISORDER (Impaired speech), PRURITUS (Itching all over body) and SWELLING FACE (Swelling on face) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Psoriasis.    The patient's past medical history included Ruptured appendix, Alcohol abuse (ABSTAIN FROM ALCOHOL), Appendectomy and Cesarean section. Concurrent medical conditions included Benign ovarian cyst, Psoriasis, Penicillin allergy (ITCHING AND SWELLING) and Drug allergy (ITCHING AND SWELLING). Concomitant products included PRAVASTATIN for Cholesterol high, TRAZODONE and DULOXETINE for Sleep disorder, METOPROLOL and CIPROFLOXACIN for an unknown indication.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to at an unspecified dose. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 mg. On 28-Feb-2021, the patient experienced SPEECH DISORDER (Impaired speech), PRURITUS (Itching all over body) and SWELLING FACE (Swelling on face). On 02-Mar-2021, the patient experienced GALLBLADDER DISORDER (Gall bladder not working). On an unknown date, the patient experienced PRURITUS (Itching and bottom swollen after COVID vaccine), SWELLING (Itching and bottom swollen after COVID vaccine), PAIN (Extreme pain) and VOMITING (Vomiting). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (oral) at an unspecified dose and frequency. On 03-Mar-2021, SPEECH DISORDER (Impaired speech) and PRURITUS (Itching all over body) had resolved. On 08-Mar-2021, SWELLING FACE (Swelling on face) had resolved. On 10-Mar-2021, GALLBLADDER DISORDER (Gall bladder not working), PAIN (Extreme pain) and VOMITING (Vomiting) had resolved. At the time of the report, PRURITUS (Itching and bottom swollen after COVID vaccine) and SWELLING (Itching and bottom swollen after COVID vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Lab data : Computed tomography scan (02 MAR 2021): Abdomen gall bladder was not working.
78 y.o. male patient of MD with history of CAD w/stent, CHF, CVA, DM, HTN, neuropathy, who presented to Hospital with dyspnea    Acute hypoxic respiratory failure  Covid Pneumonia/CAP Sepsis  Symptoms present on admission: Cough, shortness of breath and malaise Afebrile, HR 120's, WBC 11k Date of covid positive test: 3/17/23 Vaccination status: vaccinated Imaging: CTPA 3/17 showing left lower lobe consolidation. Neg PE.  Oxygen requirements on admission: 4 L NC, 89% on RA Continue CAP coverage for any secondary infection, continue Decadron and Remdesivir  Blood cx -NGTD urinary antigens not sent  Able to wean off oxygen, on room air O2 sats remained stable even with exertion Completed 5-day course of remdesivir, continued Decadron for 5 more days at discharge Continue Omnicef for 5 more days at discharge, completed Zithromax course On the day of discharge denies shortness of breath, able to ambulate without difficulty     AKI on CKD (Resolved) Hyperkalemia (Resolved) Baseline Cr 1.0 - 1.1, creatinine trended up to 1.3,  held diuretics.  Hyperkalemia treated with Lokelma Creatinine back to baseline, resumed torsemide 10 mg every other day and spironolactone 25 mg daily Creatinine remained stable, recommended to resume lisinopril at 2.5 mg daily if blood pressure greater than 140 Follow-up BMP in 2 to 3 days after discharge     CAD  HFrEF Hx of PCI in 2008  Follows with Dr.  Echo 9/2021: EF~45% Trop and NT pro BNP neg on admission Cont ASA, statin, BB Resumed Aldactone and torsemide as mentioned above  HTN  Adjusted blood pressure medications as mentioned above   Asthma No wheezing No home O2 Cont home inhalers, prn albuterol    DM Home Rx; glimepiride and metformin Last A1c 8.4 (5/2022) Resume Amaryl, metformin Januvia and glipizide and empagliflozin at discharge     GERD No active symptoms  Continue antacids
Painful rash of hands, forearms, lower legs and feet. Erythema, bullae on fingers and great toes; erythema and (?)bruising on knees and R foot. Desquamation of fingers. She got the rash on her hands and forearms after the 1st shot.  After the 2nd shot, she got the rash on the hands and also the knees, feet and great toes.  No difficulty breathing or swallowing. No involvement of mucus membranes. Afebrile and hemodynamically stable.
Convulsions. Arms and legs shaking so badly I thought I was having a seizure. I could not hold items in my hands.
Next morning felt fatigued and had fever of 102.2. Went to ER again and told them that it was a possible viral infection so prescribed CIPRO. The fever subsided but still has fatigue and joint pain. Went to private doctor 9/6 who run lyme disease test. Also has severe headaches.
Five days post vax, pt experienced a headache and chills off and on. She also experienced muscle and joint pain of her fingers, knees, hips, wrists, and legs which started between7/22/99 and 7/29/99. She was seen by a physician and treated with Advil.
FLU LIKE SYMPTOM; This spontaneous report received from a patient via a company representative concerned an adult male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported.  The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the subject experienced flu like symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu like symptoms. This report was non-serious.
1) Arm began hurting approximately 3 hours after the injection. Terrible pain. Took 2 extra strength  Tylenol which did nothing to help. Applied ice to injection site, which also did nothing to help pain which continued to worsen. Have had many injections in my life for the purpose of vaccination. Prior to this, the west was tetanus. This injection made tetanus feel like a tickle in comparison.Started feeling feverish at bedtime, around 9pm. Awoke at approximately 1am on 6/29 with a fever of 101.8 and terrible chills. Took more Tylenol (2 extra strength). Felt weak the entire next day (Friday, June 29th.) Loss of appetite, no energy. Stayed home from work. Gradually improved and was able to return to work on Monday July 2, 2018, but still did not have my usual energy.  Two weeks after the vaccine, on Saturday July 14, 2018 at approximately 3am, I awoke with a horrible pain in my left eye, which felt as though someone had inserted a huge needle into my eyeball and just left it there. I used warm compresses after carefully washing my hands, to no avail.I also took two extra strength Tylenol which did nothing to alleviate the pain in my eye. When my husband awakened at about 7 am, I had him look in my eye, which he said was exceedingly red. By 8:30am, I phoned my eye doctor, Dr. He saw me in his office at approximately 10:30 that morning and diagnosed a torn cornea. Although my vision is no longer 20/20, I basically only need glasses to read and have NEVER had any eye or visual difficulties. I asked Dr. if the torn cornea might possible be related to the Shingrix vaccine and his response was that he could not rule it out. He prescribed an antibiotic eye drop and Refresh Artificial tears (daytime use) and Genteal Gel for nighttime use. I recovered from the pain of the  torn cornea in a couple of weeks, but it took longer to heal completely but still use the drops and gel to this day.
Test and s/x onset 5/17/21- Cough, headache sinus pressure Two young children positive prior... suspect high viral exposure is to blame for breakthrough infection. Her symptoms are mild.
Pt received Pneumovax in her right arm, which she had also received 5 years ago without incident.  About 1/2 hour after pt received vaccine she noted pain and swelling at injection site.  No other complaints.  No difficulty swallowing.
Information has been received from a consumer concerning her 15 year old daughter with no medical history or allergies who on 17-NOV-2009 was vaccinated with her first dose of GARDASIL. There was no concomitant medication. On 19-NOV-2009 the patient had stomach ache and nausea. The patient also mentioned her left arm was still sore where the injection was given. Blood work was performed but the result was unknown. The patient did not seek medical attention. At the time of report, the patient's outcome was unknown. Additional information has been requested.
Fever topping at 102.7. Fatigue. Chills. Headache.  Nausea.  Debilitating flare of Rheumatoid Arthritis.  Fever and chills lasted about 24 hours. Rest lasted about 48.
Reaction started with redness and swelling x 2-3 days. developed into a golf ball sized boil with red swelling and a white center x 1-2 weeks,. Very hard to the touch, took almost a year to go away. Skin at site is still indented. Stated pt recovered until the age of 12 when the onset of TypeI diabetes happened.
A report was received from a health care professional on 11/22/2002 concerning a group of vaccinees less than 4 years old of unknown demography who inadvertently received Fluvirin from approximately 11/07/2002 onwards. From 11/07/2002 Fluvirin was administered to vaccinees less than 4 years old. There were no reported adverse events. There was insufficient information to determine the reporters causality assessment.  Update1. 12/10/2002: A follow up report was received from a health care professional on 12/10/2002 indicating that a 3 year male vaccinee was inadvertently administered Fluvirin intramuscularly on 11/19/2002. the vaccinee experienced no adverse reactions. Cross Reference with; PJP200200848, PJP200200849, PJP200200850, PJP200200851, PJP200200853, PJP200200854, PJP200200855, PJP200300856, PJP200200805, PJP200200806, PJP200200858, PJP200200859, PJP200200860, PJP200200861, PJP200200862, PJP200200863, PJP200200864, PJP200200865, PJP200200866, PJP200200867, PJP200200868, PJP200200869, PJP200200870, PJP200200871, PJP200300872, PJP200200873, PJP200200874, PJP200200875, PJP200200876, PJP200200877.