chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Client was at the COVID-19 clinic on 11-22-22 and was supposed to receive the Pfizer 5-11 bivalent booster, but the nurse accidently gave him the Pfizer 12+ bivalent booster instead.  The error was discovered when going through the paperwork/consents. The morning of 11-23-22 the state was contacted regarding the error and we immediately called the mom, to let her know as well. Mom said her son was at school and was feeling fine. We explained that he received a higher dose of the booster and to monitor for increased side effects/ response, but otherwise he should be fine and that it is a valid booster dose. We told her to call with any questions or concerns or to contact her provider. We also explained we would be completing a VAERS report due to the error.
Received booster shot on the afternoon of 7 December. From the afternoon of 8 December until the morning of 9 December, I experienced fever and chills. From 9 December-13 December, had a rash at the injection site. On the evening 14 December, began experiencing shortness of breath. Sypmpton continued until 17 December when pain on the left side of my chest occurred in connection with shortness of breath. Rapid Covid Antigen Test results were negative. On 17 December, was prescribed Prednisone by doctor. Pain in the chest subsided by 20 December however shortness of breath continued. On 24 December, pain on the right side of the chest began. The pain subsided by 26 December but shortness of breath continues.
6 weeks after her second Pfizer vaccine, my mom was sitting at the kitchen table after eating breakfast when she had a syncopal episode (she was unresponsive and lost consciousness for a few minutes).  I called 911, and when the paramedics came, her blood pressure was very low and she was sweating heavily.  She was very weak and couldn't stand up.  She had a similar episode 10 days earlier while having a bowel movement (and also experience diarrhea at that time).  She was taken to the ER and was admitted to the hospital for 2 days where testing was done.
Stomach hurt; Back pain; Not feeling good; Headache; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Stomach hurt), BACK PAIN (Back pain), MALAISE (Not feeling good) and HEADACHE (Headache) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ABDOMINAL PAIN UPPER (Stomach hurt), BACK PAIN (Back pain), MALAISE (Not feeling good) and HEADACHE (Headache). At the time of the report, ABDOMINAL PAIN UPPER (Stomach hurt), BACK PAIN (Back pain), MALAISE (Not feeling good) and HEADACHE (Headache) outcome was unknown.            The patient received booster dose last year,2021 around November December.It was unsure that the patient received Moderna as primary series. No concomitant medications were reported. No treatment medications were reported.
Mother telephoned to report temperature of child increased to 104 degrees through the night. Mother reported at 6 month physical exam - increase above 105 degrees.
shingles like local reaction after the administration of first dose; This case was reported by a physician via call center representative and described the occurrence of local reaction in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced local reaction. On an unknown date, the outcome of the local reaction was unknown.   It was unknown if the reporter considered the local reaction to be related to Shingrix.  Additional details were provided as follows: The age group was not reported, however it was captured as an adult as per vaccine indication. The age at vaccination was not reported. The physician reported that the patient presented shingles like local reaction after the administration of first dose of Shingrix (occurred a year ago, no specific date informed). The reporter did not consent to follow up. This case has been linked with US2020216258 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020216258:Same reporter
Fast and constant low frequency throbbing or tapping sound in my left ear that would go on continually and briefly pause and then resume. I noticed that if I put in an earbud or there is sufficient noise, I do not notice it but otherwise it is fairly annoying and made it harder to fall asleep. I took a hot shower and it seemed to help but the sound came back not long after.
Half of her body paralyzed; This spontaneous case was reported by a pharmacist and describes the occurrence of HEMIPLEGIA (Half of her body paralyzed) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007c21a) for an unknown indication.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEMIPLEGIA (Half of her body paralyzed). At the time of the report, HEMIPLEGIA (Half of her body paralyzed) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product use was provided by the reporter.    No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 24-Nov-2021: Follow-up received on 24 Nov 2021 contains no new information.
Post vaccine, patient vomited, felt dizzy & was pale.  Empress EMS checked out. PT transported to  Medical Center.
On April 10, 2021 I received my 2nd dose of moderna vaccine. The following day, my arm felt sore and I felt feverish. I went to bed that night (took a nyquil)  still feeling feverish and my arm still sore. By the next morning I was feeling better and the soreness in my arm was gone but instead I felt  pain that starts from my upper arm and goes all the way down to my forearm. Sometimes, I feel a tightness that starts around my neck area and goes down to my upper arm and will always linger on my forearm. I get this sharp, intense pain throughout the day. I tried icing it, I tried tylenol, aleve, ibuprofen, Icy Hot, ben gay, and salonpas. None seems to work. After about a week, I went to see my doctor and she prescribed Gabapentin for the pain. My doctor didn't really know what was causing the pain in my arm since the vaccine is still new. Unfortunately, I had to stop taking the medicine in about a week since it didn't help with the pain and it caused me to have blurry vision and insomnia. It is now April 26 and I'm still experiencing the same pain in my left arm. I have not been able to sleep on my left side and have a hard time sleeping at night due to the pain. Tomorrow I will email my doctor.
pt recv vax; pt had been screaming since lt clinic;apap given w/o success; MD called;advised to give pt apap gtts & in 3 hr give liquid dph;
Patient states that immediately upon injection it was extremely painful. He states he has had constant pain and reduced range of motion since injection. He is a health care provider and is stating he believes this is a shoulder injury due to injection.
PASSED OUT; LIGHT HEADED; SHIVERING; HARD TIME REGULATING ITS TEMPERATURE; SENSITIVE SKIN; This spontaneous report received from a female of unspecified age reporting on self via social media. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 11-MAR-2021, the subject experienced sensitive skin.  On an unspecified date, the patient stated that the side effects for her were bad but short lived, got light headed and passed out in her kitchen, if she felt light headed, sat or lay down so she could not fall, her body also had a hard time regulating its temperature (temperature regulation disorder). The patient was shivering uncontrollably for about an hour, and then overheated very quickly under all blankets. On 11-MAR-2021 the patient mentioned that her skin feel sensitive, otherwise she was fine. She got the shot yesterday. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from light headed, was recovering from shivering, and sensitive skin, the outcome of passed out and temperature regulation disorder was not reported. The reporter considered the causality between JNJ-78436735, and light headed, shivering, sensitive skin, passed out and temperature regulation disorder as related. Company causality between JNJ-78436735, and light headed, shivering, sensitive skin, passed out and temperature regulation disorder was possible This report was serious (Other Medically Important Condition).; Sender's Comments: 20210322217-JANSSEN COVID-19 VACCINE-Passed out. This event   is considered unassessable. The event has a compatible/suggestive   temporal relationship, is unlabeled, and has unknown scientific   plausibility. There is no information on any other factors potentially   associated with the event.
chills; sore arm; body aches; feverish; small lump in the arm pit; headaches; This is a spontaneous report from a contactable consumer or other non hcp. A male unspecified age (45 units not reported) patient received bnt162b2 (Pfizer covid vaccine, Formulation: Solution for injection in pre-filled syringe, Batch/lot number : Unknown), dose 1 via an unspecified route of administration on 23Mar2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. On 23Mar2021, patient received Pfizer covid vaccine. On 24Mar2021, patient reported he experienced chills, sore arm, body aches, feverish, small lump in the arm pit and now headaches. The outcome for all the events was unknown. No follow-up attempts are Possible.
She felt bad as well; Dizziness; Sore arm; Fever; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (She felt bad as well), DIZZINESS (Dizziness), PAIN IN EXTREMITY (Sore arm) and PYREXIA (Fever) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 Vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (She felt bad as well), DIZZINESS (Dizziness), PAIN IN EXTREMITY (Sore arm) and PYREXIA (Fever). At the time of the report, FEELING ABNORMAL (She felt bad as well), DIZZINESS (Dizziness), PAIN IN EXTREMITY (Sore arm) and PYREXIA (Fever) had resolved.            Concomitant product use was not provided by the reporter.  No treatment information was provided.   This case was linked to MOD-2021-079407 (Patient Link).
This case was reported by a pharmacist via call center representative and described the occurrence of malaise in a male patient who received SHINGRIX for prophylaxis. On 24th August 2018, the patient received SHINGRIX. In August 2018, less than a week after receiving SHINGRIX, the patient experienced malaise, influenza-like symptoms and headache. In August 2018, the outcome of the malaise, influenza-like symptoms and headache were recovered/resolved. It was unknown if the reporter considered the malaise, influenza-like symptoms and headache to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. This case is linked with US2018155164, reported by same reporter.
At time of injection patient reports not feeling sick. Patient reports feeling pain and aches the next day after immunization at site of injection and around body. Patient reports symptoms of fever, headaches, and cramps. Patient later went to care clinic and was told she had symptoms of the flu and given a prescription for Tamiflu. Time course: 9/24/2019 immunization given at 11:47am. Patient reports symptoms started on 9/25/2019 at 6:00am and did not resolve. Patient went to prompt care around 6pm and given tamiflu prescription.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Nausea-Mild, Systemic: Vomiting-Mild, Additional Details: Patient was very anxious about the vaccination. Within a few minutes of vaccine administration she passed out. She was awoken shortly after. When i went to check on her she was conscious and responsive. She told me she had no trouble breathing and she believed she was having a panic attack. I gave the patient water and helped her sit up while waiting for EMTs to arrive. The patient also experienced symptoms of nausea/vomiting. She decided to go to the hospital for further evaluation to be safe.
Expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 63-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 02-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment information was not provided. It was reported that vaccines were stored in freezer and they took out one to two vials and placed in fridge each day as needed.
Patient's last known normal 7/10 at 0300. Presented to ER on 7/11 with symptoms of imbalance, slurred speech, difficulty swallowing, left side felt week. The previous day, the patient woke up with slurred speech, imbalance, fatigue and slept all day. Patient has no history of stroke, CVD. Does have history of hypertension and hyperlipidemia that is untreated. Patient did not qualify for TPA and was admitted for treatment on the general medical floor. Patient's blood pressure and heart rate continued to rise and was transferred to ICU.
pt recv vax 29JAN94 & presented w/fever 103.7 R; 3FEB exp febrile sz; hospitalized 3 days; WBC 13,500 on admission; dx febrile sz, UTI (organism unidentified), bronchitis; rx w/Rocephin & nilstat; pt recovered;
Had a extremely bumpy itchy rash all over my body; All over my body with welts under my left arm (the arm I received the vaccine in).; she was left with the rash on my left and right thigh; This is a spontaneous report received from a contactable consumer (Patient). A 69-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EL8982), via an unspecified route of administration, administered in Arm left on 21Jan2021 at 12:00 (age at vaccination 69-year-old) as dose 1, single for COVID-19 immunisation. The patient medical history was not reported. Concomitant medications included ROSUVASTATIN. The patient previously took zinc and experienced allergies. Prior vaccines within 4 weeks were reported as none. The patient was not diagnosed with COVID-19 prior to vaccination. Since vaccination patient was not tested for COVID-19. Patient received vaccine facility in hospital. On 21Jan2021 at 12:00, the patient reported that she had an extremely bumpy itchy rash all over my body with welts under my left arm (the arm I received the vaccine in). The rash got better but she was left with the rash on her left and right thigh, it was worse on her left thigh. The next morning the pharmacist recommended Benadryl Allergy Diphenhydramine HCI antihistamine which she took for three days. Therapeutic measures were taken as a result of the event which included treatment with cortisone 10 cream with aloe/Benadryl tablets. The outcome of the events was not recovered.   Follow-Up (27Aug2021): Follow-up attempts are completed. No further information is expected.
CARDIOGENIC SHOCK 2/17/2023 MONOCLONAL GAMMOPATHY OF UNDETERMINED SIGNIFICANCE CARDIOGENIC SHOCK 2/17/2023 DIASTOLIC HEART FAILURE, ACUTE ON CHRONIC DIASTOLIC HEART FAILURE, UNSPECIFIED ACUITY
Site at (L) deltoid red and swollen. Symmetrical circle about 8 1/2 cm. Began this AM (5/24). Received 5/22, went swimming 5/23.
ARTHRITIS WENT OUT OF CONTROL; LOW TEMP; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included: arthritis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced arthritis went out of control, and low temp. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) Low. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from arthritis went out of control, and the outcome of low temp was not reported. This report was non-serious.; Sender's Comments: Medical assessment comments not required as per standard procedure as the case is considered non serious.
Headache fatigue, chills Narrative:  The morning he received the vaccine, patient reported feeling tired and experiencing chills and a headache. He denied any history of ADRs to vaccines, and denied any treatment.
Patient complained of dizziness, itching of throat during observation. Vital signs initiated, patient throat assessed, redness of throat observed. Patient reported slight tightness only when swallowing, no shortness of breath. Patient remained AOX3, denied any SOB, vital signs remained stable, head clinician present during Intramuscular (right Deltoid) administration and confirmed dose. Benadryl administered to patient  at 12:48 pm. Observation was extended for additional 50 minutes, Vital signs assessed through out stay. Patient reported dizziness has subsided, patient reported itching of throat has subsided 4 minutes after IM Benadryl was administered. Vital signs WNL. Patient was able to stand up, ambulate on her own. Patient reported symptoms has resolved. Patient left facility at 1:43 pm, in no distress.
rash appeared evening of 28SEP98 from back of neck to jaw line & abd @ 530PM;T104.6 given 1 1/2dropper of APAP;taken to ER 630PM;T100.9;possible OM;taken to MD dx URI-started on ceclor attributed rash & temp to MMR;
3 days post vaccination resident had increase confusion, new hallucinations, combative behavior. UA, blood work, CT of head, negative for acute findings, Hospital stay x 2 occurrences, including psychiatric evaluation. Follow up with neurologist pending .
COMPLAINED OF LEFT SCAPULAR PAIN STARTING 2 DAYS AFTER THE VACCINE AND LASTING UP TO 2 WEEKS. HOME CARE COSISTED OF DAILY ICE PACKS TO RELIEVE THE DISCOMFORT.
ABOUT 1 MINUTE AFTER IMMUNIZATION, PT STATED FEELING DIZZY. PT LOST CONSCIOUSNESS, MUSCLES TIGHTED AND SPASMED, MOVE PT TO FLOOR AND HELPED HIM TO REGAIN CONSCIOUSNESS, TAKING AWHILE TO COME AROUND SO 911 CALLED AND CHECK OUT PATIENT, HAD LOW BP, TRIED TO GET UP AND GOT DIZZY AGAIN, PT STAYED ABOUT 30 MINUTES AND WAS WHEELED OUT TO CAR BY EMS, REFUSED ER VISIT.
77 y.o. M w/ PMH of Psoriasis, Dermatitis and HTN presents to primary care for a follow up. Pt was overdue to receive Pneumococcal vaccine. Pt received 0.5ml Pneumococcal inj on 2/21/12. A rash appeared all over arms, chest, abdomen and back after receiving the vaccine. Pt had no previous allergies listed. Treatment Drugs Used: 1. Prednisone Dose: 40 Units: Every day Route: PO. 2. Hydroxyzine Dose: 25 Units: MG Freq: QID Route: PO.
Swelling; numbness; lump under left  arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 08Nov2021 03:45 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1, lot number unknown, administration time=03:15 AM, vaccine location=Left arm), administration date: Sep2021, for Covid-19 immunization. The following information was reported: SWELLING (non-serious) with onset Nov2021, outcome "not recovered", described as "Swelling"; HYPOAESTHESIA (non-serious) with onset Nov2021, outcome "not recovered", described as "numbness"; AXILLARY MASS (non-serious) with onset Nov2021, outcome "not recovered", described as "lump under left  arm". Therapeutic measures were not taken as a result of swelling, hypoaesthesia, axillary mass. Additional information: This report was received via an agency. The patient received BNT162B2 in hospital and she was not pregnant when vaccination. The patient didn't receive other vaccine in 4 weeks, she had no COVID-19 prior vaccination and didn't test Covid-19 post vaccination. It was reported the events started at Nov2021 03:15 pm. The events didn't result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No treatment was taken for the AE.  The lot number for bnt162b2 was not provided and will be requested during follow up.