chrisvoncsefalvay/vaers-outcomes huggingface dataset:
He started suddenly screaming. I could not console him. He appeared, in his reactions, that he could not see. He was flailing his arms in the air in a state of panic. He also appeared to be in extreme pain. His body would jerk and he would scream even louder. His screaming continued for several hours. He could not look at me or other family members and would avoid eye contact. He could not nurse and appeared to not be able to latch on. He continues now to whimper and his legs are in a lot of pain. I can't even touch them lightly. He continues to jerk and be hypersensitive.
36 hours after immunization right arm localized 6 cm - erythema no Cellulitis.  Slightly tender.
with the 1st vaccine on March I developed Pityriasis Rosea my body was full of it and lasted 5 months to clear  with the 2nd vaccine In just started again with the rash so far 5 point on my body, this time they itch
Headache, Fever, NauseaVomiting, Fever, severe headache, injection site pain (lasting 3 days), chills, fatigue, nausea Narrative:
No additional AEs were reported; 14 patients received possibly improperly stored vaccines due to lack of temperature readings.; This spontaneous report was received from a healthcare worker and refers to a patient of unspecified age and gender.  The patient's concurrent conditions, medical history, and concomitant therapies were not reported.  On 28-FEB-2022, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, (strength, dose, frequency, and route of administration were not provided); which lot # T028582 has been verified to be a valid lot number with expiration date: 04-MAR-2023, administered as prophylaxis. The administered dose of the vaccine possibly experienced a temperature excursion (product storage error) since 10-JAN-2022, due to lack of temperature readings (refrigerator and freezer temperatures were not recorded since that date). No previous temperature excursion occurred. There was no adverse event reported.   This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2205USA000544: US-009507513-2205USA000524: US-009507513-2205USA000533: US-009507513-2205USA000467: US-009507513-2205USA000464: US-009507513-2205USA000503: US-009507513-2205USA000560:
Started to have chest pain in the morning after the shot.  Worse when he was walking, went away with ibuprofen use.  No Dyspnea, no tachycardia.
Itching and hives starting from feet and then spreading to itching and hives on legs, back, stomach, arms, hands and feet.   Has not stopped since then.  Did take 2nd dose of pfizer on 5/6/21, Moderna booster on 11/6/21 and Pfizer booster on 5/15/22.
Steady, persistent cough. Irregular periods: increase in frequency (4 periods since booster: Oct 29th, Nov 11th, Nov 30th, Dec 16th).
Information has been received from a physician concerning a 5 year old male who in approximately 2003 was vaccinated with a dose of MMR. Concomitant therapy included VARIVAX. Subsequently the patient experienced rubella and mumps (time of experience unknown). Unspecified medical attention was sought. Follow-up information received from the nurse indicating that the vaccination was given on 16-JAN-2003. It was also mentioned that the event was "Clinically Rubella and Mumps 1 week following MMR vaccine". The patient required an Emergency Room/Doctor visit. The patient had recovered from the event. No further information expected.
10 minutes after administration of Gardasil in left deltoid, patient reported feeling a little dizzy.  She was seated and instructed to hold her head down between her knees, with some improvement.  Vital signs included B/P 76/50 (left arm) [B/P from 20 minutes earlier was 98/70]. Patient was monitored for 45 minutes, given Gatorade 12 oz and 16 oz water.  Symptoms of dizziness completely resolved, with persistent stable B/P in the 90s/60s, both arms, sitting and standing.
No adverse event; Pharmacy manager stated the vaccine was administered to one male patient on 19-May-2023; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Pharmacy manager stated the vaccine was administered to one male patient on 19-May-2023) and NO ADVERSE EVENT (No adverse event) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 062F22A) for COVID-19 prophylaxis.     The patient's past medical history included Obesity. Concurrent medical conditions included Diabetes, Heart disorder and Kidney disorder.    On 19-May-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 19-May-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Pharmacy manager stated the vaccine was administered to one male patient on 19-May-2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Pharmacy manager stated the vaccine was administered to one male patient on 19-May-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Pharmacy manager stated the vaccine was administered to one male patient on 19-May-2023).    Patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. No concomitant medication was reported.  Expiration date was reported as 17-MAY-2023. No PQC was reported. No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-725910, US-MODERNATX, INC.-MOD-2023-725921 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-725910:(Female patient no-1) US-MODERNATX, INC.-MOD-2023-725921:(Male patient no-2)
Presented to the ER on 3/26/21 with complaint of shortness of breath/not being able to take a deep breath. CTA Pulmonary Embolism W IV Contrast at that time revealed an acute PE RIGHT lower lobe without RIGHT heart strain.. Patient was started on heparin drip and transitioned to Eliquis (apixaban). She improved during hospitalization and was discharged on 3/31/21.
Chills, dizziness, left arm pain one day after vaccine. Treatment-Motrin, fluids.
1 week after getting the vaccine, the site of the injection has swelled and there is an about 2 inch, red circle formed around the injection site.  The area is very itchy and sore.  Prior to this, I had no other symptoms from the vaccine.
Vial puncture 11/11/21dose given kept in refrigerator after puncture; Patient received a dose of a vial after 12 hours of initial puncture; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received a dose of a vial after 12 hours of initial puncture) and PRODUCT STORAGE ERROR (Vial puncture 11/11/21dose given kept in refrigerator after puncture) in a 29-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939902) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received a dose of a vial after 12 hours of initial puncture). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial puncture 11/11/21dose given kept in refrigerator after puncture). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Patient received a dose of a vial after 12 hours of initial puncture) and PRODUCT STORAGE ERROR (Vial puncture 11/11/21dose given kept in refrigerator after puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported No treatment information was provided  The vial punctured on 11 Nov 2021 dose given kept in refrigerator after puncture.
Flu-like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu-like symptoms) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Hidradenitis suppurativa.    Concurrent medical conditions included Hidradenitis suppurativa (Moderate to severe).   On 01-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In January 2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like symptoms). In January 2021, INFLUENZA LIKE ILLNESS (Flu-like symptoms) had resolved.            No concomitant medication provided. No treatment information mentioned.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The formulation for Co-suspect product Humira was reported as Solution for injection in pre-filled pen  On an unknown date, patient had back surgery, a spinal operation NOS. Trying to recover as of 04JAN2022.  Somewhere in JAN2021, the patient felt like flu and event resolved.   Reporters causality for event with Humira was not provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in   This case was linked to MOD-2021-624624 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 10-Jan-2022: Significant follow up. Event added to narrative.
minor sore arm; Early second dose / First dose on 21Sep2020 / Second dose on 27OCt2020; This case was reported by a pharmacist and described the occurrence of drug dose administration interval too short in a 62-year-old female patient who received Herpes zoster (Shingrix) (batch number 23B54, expiry date 25th September 2022) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 27th October 2020, the patient received the 2nd dose of Shingrix. On 27th October 2020, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.  Additional details were provided as follows: The patient received 1st dose on 21st September 2020. The reporter stated that, the patient received 2nd dose early than the recommended schedule, which led to shortening of vaccination schedule. The reporter consented to follow up. This was 1 of 2 linkied cases, reported by same reporter for different patient.  Follow up information received from pharmacist on 23rd December 2020: The patient had no medical condition and or known allergies. Updated patient details. The patient received Shingrix by intramuscular route. Shingrix vaccine to be recommended to be administered 2 months apart, 2nd dose given at 5 weeks which led to drug dose administration interval too short. The patient experienced minor sore arm. The reporter considered minor sore arm to be related to Shingrix.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020213911: same reporter
Itchy body rash Redness Swelling of face/jaw/lips/tongue/throat
Headache, chills, soreness and tingling in right arm at first.   Extreme pressure on chest. Extreme fatigue. Face numbness, left arm and left leg numbness. Elevated heart rate.  And persistent upper abdominal pain.
I suddenly developed intense tinnitus in my right ear. It was like if you hold a seashell up to your ear - my ear was kind of blocked with that isolation and then it was a high squealing noise that I heard. It lasted for about 5 days. It was so intense it gave me some vertigo and made it hard to hear on that side. After the weekend, I saw my doctor and he put me on Steroids. I had a bad reaction to the Steroids and I had to stop them after the 5th day. The whole thing lasted for about a week and then it kind of subsided away. At the end it came in and out a little bit and then went away.
Pt felt tingling sensation throughout body and was feeling SOB.   Patient given IM benadryl and symptoms subsided
4 hours post vax, the pt developed a low grade fever and vomited one time. Localized and extended edema of left upper arm. Examined in clinic 3 days post vax. The pt's left upper arm was indurated, erythematous, and warm.
Night of shot, pt had febrile seizures x 2 at 11pm and 2am.
was tire; fever and chill; he had swollen glands; short of breath.; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (short of breath.), PYREXIA (fever and chill), LYMPHADENOPATHY (he had swollen glands) and FATIGUE (was tire) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     The patient's past medical history included Heart attack and Stent placement.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced DYSPNOEA (short of breath.). On 05-Feb-2021, the patient experienced LYMPHADENOPATHY (he had swollen glands). On 07-Feb-2021, the patient experienced PYREXIA (fever and chill). On an unknown date, the patient experienced FATIGUE (was tire). At the time of the report, DYSPNOEA (short of breath.), PYREXIA (fever and chill), LYMPHADENOPATHY (he had swollen glands) and FATIGUE (was tire) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment product included steroids  no concomitant product was reported
pt recvd vax 21MAR95 10AM;5PM same day parent reported to MD that pt had been screaming inconsolably all afternoon & lt leg (inj site) had orange/black discolorations from site to ankle & foot;MD visit-had 4cm induration @ site;
Guest complained of right arm radiating pain to her right hand. Cold, clammy, diaphoretic, and shaking. Alert and Oriented x 4. B/P: 100/60, P ? 56, R ? 16, SPO2 ? 98%, and blood glucose reading was 85. Client reports she has a history of anxiety with injections and medical procedures. Juice with sugar provided along with 8 ounces of water. EMS provided further assessment with VS reading of: B/P: 118/70, P ? 68 SPO2 ? 99%. Guest provided 20 more minutes of observation and released with no further interventions.
I developed acute wheezing, thorat tightening and tongue nubness.  I got 50 mg Benadryl and 4 puffs ALbuterol and monitored by EMTS for 30 mins more.  I had sl elevated BP 148/86 and pulse ox at 97% and HR 95.  Symptoms improved 20 min after Benadryl so I was released hom as I had my own epi pen and was a doctor so could self monitor.
no adverse event; Administered expired vaccine 29-May-2023; Patient received Bivalent vaccine as a First dose on 29-MAY-2023; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine 29-May-2023), WRONG PRODUCT ADMINISTERED (Patient received Bivalent vaccine as a First dose on 29-MAY-2023) and NO ADVERSE EVENT (no adverse event) in a 22-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 017H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 29-May-2023, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 29-May-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine 29-May-2023) and WRONG PRODUCT ADMINISTERED (Patient received Bivalent vaccine as a First dose on 29-MAY-2023). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine 29-May-2023), WRONG PRODUCT ADMINISTERED (Patient received Bivalent vaccine as a First dose on 29-MAY-2023) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine 29-May-2023) and WRONG PRODUCT ADMINISTERED (Patient received Bivalent vaccine as a First dose on 29-MAY-2023).    Concomitant medication details not reported by the reporter. Treatment details was not reported by the reporter.
Patient reported experiencing fever, severe muscle and joint pain, joint and lymph node swelling, headache, and dizziness shortly after vaccination that lasted for 4 days.  Patient continues to experience pain and swelling at injection site (left arm and axillary).
Around 4:00 PM, left arm was swelling, ADVIL was taken, 5:30 PM swelling worse, was size of a grapefruit, hard, red and painful, ice applied which improved the pain some, temperature before going to bed was 99.9. By the next evening, the arm was swollen even into the chest and L breast area, painful. Went to the emergency room: CRP was 51, WBC 8. Was admitted and treated with 2 IV antibiotics for cellulitis. On Monday Sept 25 was discharged after being seen by her private physician. She was discharged on prednisone for inflammation, not cellulitis. Complete recovery.
6 days after the first dose, I experienced morning vertigo to the extent that I had to hold on to walls. After 12 days, that passed. 8 days after the second dose (April 8), I had vertigo when I bent over or turned my head while lying in bed especially on my back and fatigue that made me unable to walk more than 1/2 hour. The vertigo got a little better around April 19, but the fatigue remains significant
Injection site was sore, swollen, irritated, and hot to the touch (as described by patient). Patient stated she took Ibuprofen.
Information has been received from a physician concerning a 45 year old female with type II diabetes mellitus who on approximately 11/07/2005 was vaccinated SQ with a dose of Pneumococcal 23v polysaccharide vaccine (lot #649914/0578P) and a dose of influenza virus vaccine (unspecified) into the opposite arm (unspecified). Concomitant therapy included an unspecified oral therapy. Subsequently the patient developed redness, pain and swelling to the arm that was used for the Pneumococcal 23v polysaccharide vaccine. Medical attention was sought and the patient received diphenhydramine hydrochloride (Benadryl) and prednisone. Subsequently, the patient recovered from redness, pain and swelling to the arm. The physician considered redness, pain and swelling to the arm to be other important medical events (OMIC). Additional information has been requested.
Patient presented to the office for his Moderna booster vaccine (0.25 mL). It was brought to the attention of the vaccine manager that the efficacy of the vaccines being administered that morning was diminished due to the length of time that the vaccine vial had been open for. The vial had been open for 24 hours at that point in time. The patient stayed under standard observation for 15 minutes and exhibited no ill effects.
Within 6 hours, a moderate headache manifested that progressed into a severe headache by 12 hours. Patient has had a history of migraines. The was also pain at the injection site that peaked approximately 24 hours later.
a pinkish red rash, 4-5 little rashes in different parts of the body; swelling at the injection site; very little pain at the injection site; a red spot around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of RASH (a pinkish red rash, 4-5 little rashes in different parts of the body), VACCINATION SITE SWELLING (swelling at the injection site), VACCINATION SITE PAIN (very little pain at the injection site) and VACCINATION SITE ERYTHEMA (a red spot around the injection site) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH (a pinkish red rash, 4-5 little rashes in different parts of the body), VACCINATION SITE SWELLING (swelling at the injection site), VACCINATION SITE PAIN (very little pain at the injection site) and VACCINATION SITE ERYTHEMA (a red spot around the injection site). At the time of the report, RASH (a pinkish red rash, 4-5 little rashes in different parts of the body) and VACCINATION SITE ERYTHEMA (a red spot around the injection site) had not resolved and VACCINATION SITE SWELLING (swelling at the injection site) and VACCINATION SITE PAIN (very little pain at the injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information provided Treatment Cortisone cream and Benadryl   Reporter did not allow further contact
Fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) for a Pfizer sponsored program (159558).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "Fever".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
First symptoms I had was cold like symptoms. My body was painful. I had fatigue, and my nose was congested. 3 or 4 days later I got more respiratory symptoms. My chest was very congested. I lost my taste and smell. I experienced shortness of breath on the 5th or 6th day. I called a doctor and we talked and she prescribed Mucinex, Pseudoephedrine ER 120mg 2xday, albuterol 108 inhaler, and fluticasone 50mcg. The 3rd day I felt pretty bad. My heart was accelerated. I went to urgent care. They ran test and said I was okay. They told me that one of the medications I was prescribed was the cause of it. I was prescribed an anti allergic medication and another medication. My right leg started swelling. I felt a lot of pain in my leg. I went to urgent care. They suspected that I possibly had a blood clot. 2 or 3 days after that I was felling better. They said I had inflammation. I have been experiencing headaches and feeling tired for 2 or 3 weeks. My legs were a little weak. I have started to feel better now. I am 100% better. I also had one day of diarrhea.
04:15 Immediately following second injection for MMR, had slight seizure, pallor, profuse diaphoresis, unresponsive. Ammonia inhalant used; head lowered; slowly responded. Complained of nausea and shortness of breath. Continued to have profuse perspiration and complained of difficulty breathing. Nurse called 911; BP 78/52. Transported to ER.