chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a contactable pharmacist who reported the same event for two patients. This is the second of two reports. A female patient of unknown age and race/ethnicity received on 02Mar2017 PREVNAR 13 (lot number R48403, Expiration date: Apr2018, NDC: 00005197102, UPC: 300051971022) at 0.5 ml single dose to prevent infection by pneumococcus. Relevant medical history included constipation. Concomitant medications included Albuterol every 4 hours as needed for respiratory disorder; rectal DULCOLAX, suppository 10 mg, daily as needed for constipation; rectal FLEET ENEMA daily as needed; ophthalmic XALATAN 2 Gtt, one drop in each eye daily; oral levothyroxine 88 ug, once daily; and oral TYLENOL (tablet, 325 mg) 650 mg, thrice daily (two tablets three times daily). In Mar2017, the patient experienced a little bit of red area at the injection site. Outcome was not recovered. Sender's Comments: Linked Report(s): US-PFIZER INC-2017108862 Same reporter/drug/event different patients.
Patient noted on vaccine follow-up that developed fever, chills the evening after vaccine. Patient obtained COVID test that was positive. No symptoms were experienced prior to vaccine. Likely unknown exposure to COVID prior to vaccine. Patient did not note need for hospitalization for COVID and recovering at home. Feels better at the time of follow-up.
Very painful swelling of the right armpit starting 10-12 hours after receiving the vaccine. Pain is manageable with ibuprofen, but difficult to tolerate without pain reliever. Swelling is significant enough along with pain that lowering right arm is difficult and very uncomfortable.
It?s was the 2023-2024 Pfizer Comirnaty for XBB 1.5. Fever of approximately 100.4 F (normal temp is 98.0) Severe night sweats Nausea, until bowels were vacated.  Almost passed out while getting up. Back pain Stunned and groggy the next day Effects still felt 48 hours later, and then better in the evening, but back again on day 3 (sensation of low-grade fever).  Day 4 seems normal Topical reaction near injection site appearing (or being noticed) 48 hours after injection: approx 2 inches down from injection site, at conjunction between deltoid and bicep. Swelling with four red splotches (flower-like) surrounding central whitish area.  Red is gone on day 4. Central area barely noticeable.  No more swelling.
Day #1 4hrs arm pain/fever, chills, nausea could not lift arm, up all night night sweats  Day #2 Flu sx arm pain Day #3-Improving/sore arm Day #4- Day #5 feeling better/arm swollen (+) Heat (+) Erythema
Tingling of forearms and lower left leg for 5-10minutes. All tingling resolved and no other symptoms 1 hour after vaccination
Administered a Moderna Covid-19 vaccine to a patient past it's BUD labeled on the box. Contacted manufacture to confirm data stability of the vaccine. 3-5 business turn around time to hear a response since it is lot# specific. Patients and staff were informed, no further concerns at this time.
This spontaneous report as received from a company representative, reported by nurse refers to a 68 year old female patient. Medical history and current conditions were not reported. Concomitant medications were not reported. On 25-AUG-2016 the patient was vaccinated with PNEUMOVAX 23. On 07-SEP-2016 presented back to the office with cough and congestion that lasted for 6 days. On the 8-SEP-2016 she returned to office, feeling worse and was sent for an x-ray next day. The doctor suspected pneumonia and the patient was diagnosed in the hospital or emergency room, and treated with unspecified antibiotic and the patient progressively got worse. On an unknown date in 2016, just a couple of days after that, the patient presented in the emergency room and ended up staying a week in the hospital, "O2 sat of 84" (as reported). The pneumonia was ruled out and doctor decided that it was a severe reaction, respiratory distress reaction to PNEUMOVAX 23. The patient is alive and was dismissed from the emergency room. The outcome of respiratory distress was unknown. The reporter considered the event respiratory distress to be related to the suspect therapy. The reporter did not provide the causality between the event pneumonia and the suspect therapy. Upon internal review, the events respiratory distress and pneumonia were determined to be medically significant. Additional information has been requested.
fatigue; More than 35 days between Covid-19 vaccines; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days between Covid-19 vaccines) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047B21A and 001B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-May-2021, the patient experienced FATIGUE (fatigue) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days between Covid-19 vaccines). On 14-May-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days between Covid-19 vaccines) had resolved. At the time of the report, FATIGUE (fatigue) outcome was unknown.            No Concomitant medication was reported.  No Treatment medication was reported.  Patient had received both vaccines in his right arm shoulder deltoid muscle.   This case was linked to MOD-2022-461692 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 25-Jan-2022: Follow up information was received contained siginificant information. Contact number was added.
Shingles; Missed 2nd dose; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 68-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and not applicable after receiving Shingles vaccine, the patient experienced shingles and incomplete course of vaccination. On an unknown date, the outcome of the shingles was not recovered/not resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional details provided were as follows: The case was reported by patient herself/himself. The age at vaccination was not reported for 1st dose and it was not applicable for 2nd dose. The patient missed the 2nd dose, which led to incomplete course of vaccination. At the time of reporting, the patient had actual shingles. The patient asked after the recovery from shingles if he/she need to start with the 1st dose again then would make sure to get the 2nd dose. The reporter consented to follow-up.
A report has been received from a Pharmacist concerning a 5 year old, subject of unknown gender, who had been receiving FLUMIST quadrivalent (intranasal). FLUMIST quadrivalent (intranasal) started on an unknown date. The patient experienced half dose of FLUMIST quadrivalent given. The outcome of the event of half dose of FLUMIST quadrivalent given is unknown. The report was considered to be non-serious.
Client did not receive full dose of vaccination. The vial that the client received the booster dose from was inadvertently diluted a second time with saline after vial was used. local Department of Public Health notified and gave recommendation to report VAER, notify client, and give recommendation to client that client received some vaccine, but not full booster dose. Due to receiving a partial dose, no further doses are recommended. 10/20/2021, 1342, client notified and given all information with good understanding verbalized.
heavy right leg pain, weakness in leg and still having problems walking with leg. Cannot stand for long periods of time , Leg Feels fevered at night. Have used all kinds of cream and patches for pain and still hurts. Never any problem with right leg before 2nd dose.
Woke at 3:50am. Right ear felt as though it very much needed to pop; internal pressure beyond external areas where finger can access. Hearing very much muffled. Not tinnitus (no ringing, screeching, etc.), which I have had before (in this ear), or if it were tinnitus then a very different tinnitus. Ear not significantly different by current time, 11:10am.   Though no scientific background to connect ear issue to vaccine received around 40 hours prior, no other changes in habit or precursors.
CHILLS; FLU LIKE SYMPTOMS; JOINT PAIN; PASTY DRY MOUTH; TEMPERATURE 99.8; This spontaneous report received from a patient concerned a patient of unspecified age. 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, and batch number: UNKNOWN expiry: UNKNOWN) .5 ml, administered on 07-MAR-2021 09:40 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced chills. On MAR-2021, the subject experienced flu like symptoms. On MAR-2021, the subject experienced joint pain. On MAR-2021, the subject experienced pasty dry mouth. On MAR-2021, the subject experienced temperature 99.8. Laboratory data included: Body temperature increased (NR: not provided) 99.8 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, flu like symptoms, joint pain, pasty dry mouth and temperature 99.8 was not reported. This report was non-serious.
Pt had already received her Pfizer booster on 9/29/2021 - she had an appointment with Dr, at which time he offered her a Pfizer booster and she accepted.  We were not aware she had received her booster prior to this visit.  She had no adverse reaction to this vaccine.  Her grand daughter reported it to us on 10/26/2021.
patient had tenderness by the time he got home, then increase in dull aching pain from the elbow to left side of his neck. Patient tried tylenol every 4 hours to help with pain.  He tried a heating pad and this did not help. Patient having to sleep on back instead of left side due to pain, so he has not been sleeping well. Pain has been interfering with doing things.  Patient had some soft tissue firness in 2 places in his left upper arm.  Patient instructed to take tylenol arthritis 2 tablets every 8 hours or just twice a day. Patient to apply cold packs to left upper arm for at lease 30 minutes every 2 hours while awake.
Severe heart inflammation on autopsy; Bodies with weak immune systems; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  An adolescent patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for Covid-19 immunization. The following information was reported: CARDIAC INFECTION (death, medically significant), outcome "fatal", described as "Severe heart inflammation on autopsy"; IMMUNE SYSTEM DISORDER (non-serious), outcome "unknown", described as "Bodies with weak immune systems". The patient date of death was unknown. The reported cause of death was cardiac infection. Clinical course: Two teenagers died from the second shot. Severe heart inflammation on autopsy. Bodies with weak immune systems often don't react as fiercely as stronger ones.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Severe heart inflammation on autopsy
Severe dizziness; Nausea; This is a spontaneous report from a contactable consumer (patient) reported a 70-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date not reported), via an unspecified route of administration from an unspecified date, at a single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient is not pregnant at the time of vaccination. No allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 14Jan2021 at 14:30, the patient experienced severe dizziness and nausea.  Since the vaccination, the patient has not been tested for COVID-19. Outcome of the events was recovering. The reporter assessed the events as non-serious.  Information on the lot/batch number has been requested.
Rash similar to mild chickenpox on front of shins, over upper and lower arms, under breasts, still persistent after a week, starting to subside.
PATIENT WAS APPROACHED IN VEHICLE AND ASKED HOW HE WAS FEELING, HE SAID HE DIDNT FEEL WELL AND THOUGHT HE MAY OF PASSED OUT. HE WAS ASKED TO PUT HIS CAN IN PARK AND ROLL DOWN HIS WINDOWS. UPON HIM DOING SO HE PASSED OUT AND BECAME UNRESPONSIVE. BP WAS 62/30. 911 WAS CALLED. ICE PACKS WERE PLACED AROUND HIS NECK AS HE WAS CLAMMY AND PALE. HIS LIPS WERE PURPLISH AND OXYGEN WAS 91%. HE CAME TO A SECONDS LATER AND ASKED WHAT HAPPENED. HE THEN WHEN INTO WHAT LOOKED LIKE A SEIZURE THAT LASTED ABOUT 15 SECONDS.HE WAS ASKED IF HE HAD A HISTORY OF SEIZURES AND HE SAID NO. HIS BP WAS TAKEN AGAIN AND IT WAS 90/60.OXYGEN WAS AT 91%. WHEN HE PASSED OUT AGAIN, EPI WAS ADMINISTERED AND PARAMEDICS ARRIVED APPROX 1 MINUTE LATER
pretty sudden onset of a high fever Fever was 103.4 Called doctor's office and got on call office.  Gave tyelenol.  Fever still very high.  Fever down to 100 by 8pm. Fever was 100.5 this morning
270202; 79 y.o.; 7/1/1943; Admit Date:  7/25/2022; Discharge Date: 7/26/22; Principal Dx/ Final Dx: Closed 2-part intertrochanteric fracture of proximal end of right femur; Relevant Inpt Dx: Principal Problem: Closed 2-part intertrochanteric fracture of proximal end of right femur; Active Problems: Primary hypertension; COVID-19 virus infection; Stage 4 chronic kidney disease; Mixed hyperlipidemia; Diabetes mellitus; Chronic anemia; HPI: Hospital Course: This 79 year old man was admitted with hip fracture.  He was taken to OR and had surgical repair by orthopedics. He became hypoxic and suffered a cardiac arrest.  They were not able to resuscitate him. TOD1919 Consults:  IP CONSULT TO ORTHOPEDIC; Signed: MD; 8/4/2022; 2:47 PM.
itching @ site then gen itching & SOB-Zyrtec, maxaire, epi, pred for 5 days;
Hives scattered on my face, neck and arms; This is a spontaneous report from a contactable physician (patient).  A 37-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Solution for injection lot no: EH9899, expiry date not reported), via an unspecified route of administration on 20Dec2020 at a single dose (1st dose) then via an unspecified route of administration on 10Jan2021 (lot no: EK9231, expiry date not reported)  at a single dose (2nd dose); both on left arm for covid-19 immunization. The patient's medical history and concomitant medications were not reported. To his knowledge, patient has no known allergies.  Patient had no other vaccine received in four weeks.  Patient had One a Day multivitamin in two weeks. The patient stated on 23Dec2020, "The days after the first vaccine I had a couple hives scattered on my face, neck and arms. After the second vaccine, the hives increased in size and number. It really progressed today (3 days after the second shot)". The patient took BENADRYL, PEPCID and prednisone as a treatment for the events. Patient had no prior COVID vaccination and had not tested COVID post vaccination. The outcome of the event was not recovered.
got the flu shot again and i got the flu; Initial information received on 17-Nov-2020 regarding an unsolicited valid non-serious social media case received from a consumer.  This case involves a unknown demographics patient who got the flu shot again and i got the flu (influenza), while he/she received vaccine INFLUENZA VACCINE.  The patient's medical history included flu. Medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medications were unknown.  Past medication included influenza vaccine.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient who got the flu shot again and patient got the flu (influenza) (Unknown latency) following the administration of INFLUENZA VACCINE.  Final diagnosis was patient was Influenza.   Relevant laboratory data was not reported.  It was not reported if the patient received a corrective treatment.  The event outcome was reported as Unknown.  There will be no information available on the batch number for this case.
My daughter had her 1 year old shots on September 29th. The following Monday, she started acting very oddly, and by Tuesday, she was running a high fever, not wanting to play, smile, or even eat. (This is the same child that had double ear infection, and strep throat a few months ago, and you couldn't keep her from playing, or belly giggling at the smallest thing.) She has always been such a ham, and suddenly it was gone. When I called the doctors office, they told me it woudn't have anything to do with the shots a week later, yet, the information sheet they gave me before I left said 1 in 10 babies will run a fever 7-10 days later. The doctors office said it had to be a virus and nothing to worry about. Yet me, my husband, and the other babies I watch daily, haven't gotten sick in any way. She is no longer the child that I know, she stopped walking (only crawls), doesn't smile, throws fits for no reason, and barely eats.
Had persistent coughing and chest pain since the vaccine, also have had shingles at the same time, doctor uncertain if symptoms are all shingles-related or not. Have been prescribed medicine for shingles for 10 days.
Apprx. 12 hours after immunizations given, pt developed flu like syndrome with nausea, vomiting, fever - lasting up to 1 week. Seen in ER (occurred after Comvax # 2 and # 3)
SYMPTOMS STARTED GETTING BACK AGAIN; This spontaneous case was reported by a patient and describes the occurrence of SYMPTOM RECURRENCE (SYMPTOMS STARTED GETTING BACK AGAIN) in an adult male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to at an unspecified dose. On an unknown date, the patient experienced SYMPTOM RECURRENCE (SYMPTOMS STARTED GETTING BACK AGAIN). At the time of the report, SYMPTOM RECURRENCE (SYMPTOMS STARTED GETTING BACK AGAIN) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       No concomitant medications were reported. It was unknown if patient was enrolled in a COVID-19 vaccine trial.  No treatment medications were reported.  The reporter's causality for the event(s) of symptoms started getting back again with Humira (adalimumab) was a reasonable possibility and with mRNA-1273 (Spikevax) as possibly related.
sinusitis; soreness in the shoulder on the side she received the injection; This is a spontaneous report from a contactable nurse (patient). This female patient of unspecified age received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) via unspecified route of administration on 10Feb2021 at single dose for Covid-19 immunization. Relevant medical history included sinus infection on an unknown date ("before") treated with antibiotics ("generally the antibiotics help"). Concomitant medications were not reported. On an unknown date the patient experienced soreness in the shoulder on the side she received the injection. a couple of days ago, she reports soreness on the left side of her face, her eye was hurting and had a slightly sore throat. She noticed swelling in her eye, face, had a headache and pain. Clarified her eye was aching. Her left cheek and side of face was swollen. She visited the doctor who said it was sinusitis and gave her antibiotic: amoxicillin/clavulanic acid (AUGMENTIN) every 12hours for 10 days since 04Mar2021. The second dose of vaccine was planned on 08Mar2021. The outcome of the events was unknown.  Information about lot/batch number has been requested.
PATIENT COMPLAINED OF SHORTNESS OF BREATH AND DIFFICULTY BREATHING CAUSING RESTLESSNESS AND VIVID DREAMS
right upper arm pain developed; This is a spontaneous report from a non-contactable consumer. This adult consumer (patient) reported that: An adult patient of an unspecified gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Right on Feb2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient reported from the night of the vaccination, right upper arm pain developed on an unspecified date in Feb2021, 2 days after the vaccination, recovering. Patient received second dose of vaccination on an unspecified date, few hours after the vaccination, right upper arm pain developed. The pain was little stronger than the 1st dose. On the Second day of the vaccination, in the afternoon, there were mild sleepiness and malaise, which were recovering on the third day. The outcome of the event was reported as recovering.   No follow-up attempts are possible. Information about Lot/Batch could not be obtained. No further information is expected.
Throat swelled, chills, ears hurt, eyes red and pus in them; vaccine site very sore; trouble breathing.
Severe chills, trembling and shaking 12 hours after injection. Mild fever, sweating at night, inability to sleep, nightmares. Joint paint, heavy feeling in limbs, swollen supraclavicular lymph node on left side, localized (left side) and sharp feeling headache. Swollen feeling in eyes, discomfort when blinking eyes.
At the time of the injection, I had an electric shock strike at the back of my lower neck, did not say anything at the time...was shocked!