chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A very large area of erythema surrounding the injection site appeared and progressed to approximately 1 1/2" - 2". On 3rd day started improving. This is the second strong reaction to DTaP from same Lot in 2-3 weeks.
* Tired, woozy beginning about 6 hours after vax.  * Fever (100.2 deg), chills 9 hours after * Sudden, violent, nausea & vomiting 11 hours after vax.
pt found by mom dead in crib @ 1015AM 26AUG97;no apparent sx or signs;
This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies was provided. On 30-JUN-2016, the patient was vaccinated with an improperly stored dose of ROTATEQ, (lot # L037924, expiration date 22-JUN-2017, orally; exact dose was not reported). The reason of the call was temperature alarm received via Digital Data Logger. It was reported that the vaccine was exposed to temperature of 48 Fahrenheit degrees for cumulative 14 hours and 50 minutes before administration to the patient. No adverse effect were reported. This is one of the several reports received from the same source. Additional information has been requested.
Myalgia, Fever, shaking chills Narrative:  Other Relevant History:
10/5/09 Seasonal flu vaccine. 10/14/09 Normal prenatal exam. 10/20/09 to 10/22/09 AM vomiting, "felt a little warm". 10/22/09 H1N1-afebrile. 10/26/09 Fetal demise at 30 5/7 weeks.  10/29/2009 hospital records for 10/26/-10/27/2009. patient at at 30 5/7 wks gestation,  presented with c/o's decreased fetal movement, hx of nausea/vomiting x 2 days which resolved. Per doppler and ultrasound no FHR noted, no amniotic fluid around the baby noted. Tx: induced labor with Misoprostol/epidual anesthesia. Autopsy requested. DC DX Intrauterine Death Unspecified ICD-9 Code 656.40
17Nov97 pt recv vax. 01Dec97 pt devel rash which abated "rather quickly". Another pt had a similar exp after vax. WAES98021986.
Positive glucose test  Protein in urine Swollen feet and hands Headaches Abdominal pain Dizziness Chest pain Baby was 3lbs 2.9 oz 29 weeks pregnant baby stillbirth Positive glucose test 6/4 6/7 3hour glucose test 2hr was high protein in urine
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Nausea-Medium, Systemic: Vomiting-Medium
EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a pharmacist concerned a 51 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A expiry: 28-MAY-2021) dose was not reported, administered on 28-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 28-MAY-2021, the subject experienced expired vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine administered was not reported. This report was non-serious.
Severe shivering. Fever. Aching. Headache. No energy. Lasted all weekend.
This spontaneous case was initially received on 03-Nov-2015. The case report was received from a Health Professional and concerns a 23 years old male patient. Weight: 240 pounds, Height: 74 inches. For concomitant medication and therapy dates refer to the appropriate report sections. The patient received AFLURIA on 09-Oct-2015, Batch no: T51608, Route of administration: Intramuscular, Dose: 0.5 ml. No additional drugs suspected. On 09-Oct-2015, the patient received an IM dose of expired AFLURIA. (Medication error). For relevant test results see appropriate report section. Case correction (08-Dec-2015): AE #1 and #2 combined and coded to PT 'Expired product administered'.
Vitamin D decreased; Swelling of fingers; Rheumatoid arthritis flare up; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4308882-00.  A 57 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 23Apr2021 (Batch/Lot number: unknown) at the age of 57 years as dose 2, single and intramuscular, administration date 02Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; upadacitinib (RINVOQ), oral (Lot number: 1155129) for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RHEUMATOID ARTHRITIS (medically significant) with onset 2021, outcome "unknown", described as "Rheumatoid arthritis flare up"; VITAMIN D DECREASED (non-serious), outcome "unknown", described as "Vitamin D decreased"; PERIPHERAL SWELLING (non-serious) with onset 2021, outcome "unknown", described as "Swelling of fingers". The patient underwent the following laboratory tests and procedures: blood test: vitamin d low. The action taken for upadacitinib was unknown. Therapeutic measures were taken as a result of vitamin d decreased.  Clinical course:  She had blood work and vitamin D was low, so she was put on vitamin D3 2000 daily.It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The patient was treated with VITAMIN D 3. The reporter's causality for the event(s) of Pfizer covid-19 vaccine might triggered rheumatoid arthritis, vitamin d low and fingers started swelling was not provided. the reporter's causality for the event(s) of feet started hurting very bad with RInvoq(Upadacitinib) was no reasonable possibility.  The reporter considered "rheumatoid arthritis flare up", "vitamin d decreased" and "swelling of fingers" related to bnt162b2.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the currently available information the possibility of causal association between the events reported and the suspect drug BNT162B2  cannot be ruled out. The case will be reassessed once new information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
I got the shot the Thursday on my right arm and the flu shot on my left arm. By that evening the back of my neck was stiff and sore. The stiffness and soreness has really not gone away on my left side where I got the flu shot. It feels like a bruise if you touch the skin. I kept thinking it was swollen lymph nodes and it would probably go away. On Friday I went to the doctor and they said it was probably a reaction to the flu shot, which I have never had before and I get that shot every year. They gave me some Tylenol because I was not able to sleep at night. The week before I got the shot I was working and I strained a muscle but it was feeling better by Tuesday. I had a physical on Tuesday and everything was fine. They said it could also be just the strain in my muscle.
Patient developed chest pain and visited the emergency room the evening after she received her FLUZONE HD. She was diagnosed with Pleurisy. TORADOL was administered for the pain. During the hospital stay, a CT scan was performed and a mass was discovered. Biopsy is pending.
Redness around injection; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 29-Jan-2021 and was forwarded to Moderna on 30-Jan-2021.    This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 29-Jan-2021 and was forwarded to Moderna on 30-Jan-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Redness around injection) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (Redness around injection). At the time of the report, VACCINATION SITE ERYTHEMA (Redness around injection) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Tiny red, fluid filled bumps and crusted over, bumps all over abd, back and arms.
Woke up next AM, face was swollen, had low grade fever, face was red and hot. Pt took Benadryl and it didn?t get better, it got worse. Woke up 2nd day and swelling got much worse, and eyes were swollen shut. Went to walk in clinic and got prescribed 50mg prednisone a day.  Pt feeling better after 3 days of steroid treatment
syncope; POTS; headache; dizziness; fatigue; Information has been received from a lawyer referring to a 21-year-old female patient regarding a case in litigation. Information about concurrent condition, medical history and concomitant medication was not reported. On an unknown date, the patient was vaccinated with Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) (strength, dose, lot# and route unknown) for prophylaxis. On an unknown date, the patient experienced postural orthostatic tachycardia syndrome (POTS), headache, dizziness, fatigue, and syncope. Reported date of injury was unspecified date in 2006. The outcome of the events was not reported. The causality assessment was considered as related by the lawyer.  Upon internal review, syncope was determined to be medically significant.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2301USA006946:
No additional AE reported; an expired dose of MMRII had been administered to a patient; This spontaneous report was received from a nurse practitioner and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 22-JUN-2022 (reported as 22-JUN-2023 - future date), the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, expiration date: 02-JUN-2022, administered for prophylaxis (strength, dose, lot #, anatomical location, and route of administration were not provided) (expired product administered). No additional adverse event reported (no adverse event).  Follow-up information was received from a nurse practitioner on 27-JUL-2022 via a telephone call referring to an unknown gender 60-year-old patient. The primary diagnosis of the patient was anxiety, cognitive impairment, headache and status post motor vehicle accident (all diagnosis were from 2015) and prior to receiving this vaccine series. The patient was allergic to penicillin and codeine. The patient's only medication was salbutamol (ALBUTEROL) as need. On 22-JUN-2022, the patient received a single dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (albumin status recombinant Human albumin (rHA) on left arm (lot # T018892, expiration date: 02-JUN-2022). On 26-JUL-2022, she was revaccinated to the left arm with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (rHA) (lot number was T029550 expiration date was 01-SEP-2022) for prophylaxis (strength, dose and route of administration were not provided). No adverse effects and no concerns.  This case became valid due to known patient's identifier.
Patient waited the 30 minutes after receiving the vaccine, stated to have no side effects at that time. Patient left vaccine clinic. Between 10-15 minutes later patient came back stating that she was having "lip tingling".  Patient denied any other adverse reactions.  Lips appeared WNL. No redness or swelling.  Patient then escorted with RN to ED.  Once down by ED patient stated her HR was elevated at 109, and was beginning to feel dizzy.
had a little sore arm; This is a spontaneous report from a contactable consumer. This consumer reported similar events for 2 patients. This report is for 2 of 2 patient. A patient of unspecified age and gender received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported)dose 1, via an unspecified route of administration on an unspecified date as single dose for a covid-19 Immunization. The patient's medical history and concomitant were not reported. Caller stated that they were lucky enough to get first Pfizer shot last Friday, got their cards and are supposed to go back on 26Feb2021. Stated that she was trying to update their phone number for contact. Wanted to know how to reach them to update their number. Clarified that this is for the Pfizer Covid vaccine. Stated that administrator did not know if they would be there at the second location and would call them. Stated that they both had a little sore arm. The patient experienced had a little sore arm on an unspecified date in 2021 with outcome of unknown.    Information about Lot/batch number is requested.  Follow-up (11May2021): Follow-up attempts completed. No further information expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021171712 same reporter/event/drug, different patient
Received vaccine @ 08:40, @ 10:00 became dizzy with elevated blood pressure.
vial was stored in fridge for more than 12 hrs post puncture and then administered; No Adverse Event; vial was punctured on 3-Oct-2022 and administered on 4-Oct-2022/Dose administered more then 12 hours post puncture; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (vial was stored in fridge for more than 12 hrs post puncture and then administered), EXPIRED PRODUCT ADMINISTERED (vial was punctured on 3-Oct-2022 and administered on 4-Oct-2022/Dose administered more then 12 hours post puncture) and NO ADVERSE EVENT (No Adverse Event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 030G22B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 04-Oct-2022 at 8:15 AM, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 04-Oct-2022 at 8:15 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (vial was punctured on 3-Oct-2022 and administered on 4-Oct-2022/Dose administered more then 12 hours post puncture). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vial was stored in fridge for more than 12 hrs post puncture and then administered) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, PRODUCT STORAGE ERROR (vial was stored in fridge for more than 12 hrs post puncture and then administered), EXPIRED PRODUCT ADMINISTERED (vial was punctured on 3-Oct-2022 and administered on 4-Oct-2022/Dose administered more then 12 hours post puncture) 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 PRODUCT STORAGE ERROR (vial was stored in fridge for more than 12 hrs post puncture and then administered) and EXPIRED PRODUCT ADMINISTERED (vial was punctured on 3-Oct-2022 and administered on 4-Oct-2022/Dose administered more then 12 hours post puncture).    No concomitant medications was reported. The size of vial was 2.5 ml. The vial was initially stored in the refrigerator on 02-Oct-2022. The vial was first punctured on 03-Oct-2022 at 3:30 pm and administered on 04-Oct-2022 at 8:15 am. The vial was stored in fridge post puncture. The vial did not undergo any temperature excursions. The vial was exposed to room temperature range 8° to 25°C= 46° to 77°F for less than 24 hours. No treatment drug details was reported.
He has been having diarrhea for the past 2 weeks ever since he received a second Covid vaccination he has been increasingly weak and could barely make it into the pulmonary function lab.  At the pulmonary function lab, he was found to have new onset atrial fibrillation and worsening hypoxemia from baseline. Taken to ED from the lab on 5/12, found to have right middle lobe and right lower lobe consolidation and ground glass changes. Admitted.  Conditioned worsened, respiratory acidosis and shock, started on biped and pressors. Taken to ICU. Found to have RV failure. Today he was intubated.
Pt states that 30 minutes post vaccination he became ''hot and thirsty'', stopped to get ice cream and then got severe vertigo, nausea and vomiting so went to the ER for evaluation
Patient did not feel well. While seated he fainted and hit the floor and had a cut above is eye.
Received Janssen vaccine on 4/8/21 COVID-19 positive by PCR on  1/31/22 admitted to hospital 2/2/22 d/t SOB, severe sepsis without shock, COVID infection underlying CKD, HTN
Moderna COVID-19 Vaccine - Pt reported dizziness, nausea, chills and red and swollen arm after receiving her first dose of the moderna covid-19 vaccine.  Pt stated that she rested and stayed hydrated and symptoms went away after a couple of days.  She decided to forgo her second dose until she has talked to her doctor.
Swelling of left axilla/tail of spence Pain in left axilla/left breast radiating down left side of breast
left calf hot; left calf painful; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (left calf hot) and PAIN IN EXTREMITY (left calf painful) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Mar-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced FEELING HOT (left calf hot) and PAIN IN EXTREMITY (left calf painful). At the time of the report, FEELING HOT (left calf hot) and PAIN IN EXTREMITY (left calf painful) outcome was unknown.            No concomitant and treatment products reported. Action taken with mRNA-1273 in response to the events was Not Applicable.
I got the moderna vaccine at 8 weeks and 5 days; This spontaneous prospective pregnancy case was reported by an other health care professional and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (I got the moderna vaccine at 8 weeks and 5 days) in a female patient of an unknown age 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (I got the moderna vaccine at 8 weeks and 5 days). At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (I got the moderna vaccine at 8 weeks and 5 days) had resolved.        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.   concomitant and Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 06-Jan-2021: follow up received and contains no new information.; Sender's Comments: This is a case of vaccine exposure during pregnancy with no associated AEs for this female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy
VAERS completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st 01/06/21 dose pfizer,Lot#EL3248 2nd dose: 01/28/21,Pfizer,Lot# EL9262 Diagnosed covid positive:07/25/21 symptom onset:07/24/21 Exposure:Home exposure Symptoms:Muscle aches.
TIRED; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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:  Unk) dose was not reported, administered on 10-MAR-2021 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 11-MAR-2021, the subject experienced tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tired. This report was non-serious.
ACUTE HYPOXEMIC RESPIRATORY FAILURE  3/22/2022, 4/3/2022,  9/9/2022 -- RECURRENCE OF SAME SYMPTOMS
p/vax pt devel vomiting & diarrhea (mild); but associated w/extreme irritability & high pitched scream; hosp to R/O meningitis, sepsis, etc
very warm to touch, redness, small red spots appeared on arm from shoulder to elbow, pain radiating  down to elbow
Patient is a 75 y.o. male with PMH of of ESRD on HD that presented with confusion and fever. In the ER, patient had recorded fever and had an episode of hypotension that improved with IV fluid resuscitation. Patient tested positive for COVID but was not hypoxic. Fever likely secondary to covid. Urine and blood cultures negative for growth.
I received the H1N1 nasal spray from the Employee Health Nurse from my employer. On the evening after I had the Nasal Spray, I started to feel dizzy, and light headed.  No fever, difficulty of breathing or nausea, just dizziness. The next day, it disappeared.  Then came back again on the third day. It continued to come back and and go away over the next few days.  It usually happens in the evenings.  There was no change in my routine that can possibly attribute to this dizziness.  I finally reported the problem to the employee heath nurse a couple of days ago.  I was told that 3 people from the hospital is experiencing the same thing.  She advised me to go to my doctor.  I decided to give it another day to see if it will go away, plus I could not get an appointment.  I finally got to see my doctor today but he said since this vaccine is so new, he's not too familiar with it... sent me home with prescription of Meclizine.  At this moment, I am still very lightheaded and dizzy.
Patient received her vaccine on 2/7/2007 at her 1-year checkup.  On Feb 13th, patient started to have fever of 104F, 105F.  She also developed a runny nose and a scratchy throat.  After administering Tylenol the fever went down to 100, but hung on until Saturday night, Feb 17th. On Thursday night, Feb 15th, we noticed she had a slight rash on her head.  When she woke up the next day (Friday morning, Feb 16th) she was COVERED with a measles-like rash.  The rash covered her head, neck and torso (front and back).  It was really thick around her neck and ears.  As the day progressed on Friday, the rash got worse, and she became very lethargic and didn't want to eat.  That night her cheeks started to swell up as well.  Friday night/early Saturday morning, she was in a very uncomfortable state, she could not sleep and cried from the itchiness of the rash, and then her lips started to swell up too.  That was when we got really scared and took her to the ER.  There at the ER, they ran a lot of tests and told us that it was probably from the MMR vaccine. The rash started to darken on Sunday morning, Feb 18th, in transition of fading away.  We notice that she screams now when she is not happy or frustrated. And, once a while, she seems to scream out of blue.  The rash is still (Mar 5th) visible and itchy once a while since patient still attempts to scratch from time to time.