chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. In approximately 2016 (since 08-FEB-2016), the patients were vaccinated with improperly stored doses of LIQUID PEXVAXHIB (lot # L042257, expiration date 17-AUG-2018; lot # L042259, expiration date 18-AUG-2018; lot # L051123, expiration date 13-OCT-2018; lot # reported as M001811, expiration date 11-APR-2018 (dose and route of administration were not reported). There was no effect reported. Administered doses of vaccine experienced the temperature excursion of 9 degrees Celsius for 9 hours, 0.3 degree Celsius for 837 hours and 30 degrees Fahrenheit for 542 hours. Data logger was involved. There was no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.
our CMA, gave a covid vaccine from yesterday that was in the refrigerator and was officially over the number of hours that it could be used. The mother was informed of the error, along the the physician.  Dr. explained the situation to both parents. We are reporting it to our company, Hospital through a Safety Scoop.
Administed 0.5 cc Moderna Bivalent covid booster to patient, age 11 on 2/10/23. Spoke w/mom @ 9 AM Sat. 2/11/23. Advised of dosage. Mom reported patient had normal soreness @ injection site/arm. Gave instructions to mom to observe, increase H2O, ice to arm, Tylenol or motrin, offered Pharmacist consult if desired. Mom declined.
Pt received first Moderna vaccination on 3/19/21.  He reported to the Clinic on 4/8/21 for the second dose, stating that he was instructed to do so. Pt received the second dose 20 days after the first dose. Pt was contacted that afternoon to see how he was feeling.  He expressed that he was doing well.  Reviewed post vaccination info with him.  He was contacted again on 4/14/21 and he states that he did experience weakness the day after the second dose, but he was fine after that .
Within an hour after taking vaccination, one side of patients throat was in pain. Difficulty swallowing, hives, dizziness, muscle pain in upper arm at injection site.
Within one week of recieving Guardacil and meningitis vaccine on same day, had mono-like symptoms, with elevated LFTs.  10/24/2008 MR received from PCP.  OV 8/7/07 for c/o swollen glands in the neck with neck stiffness and soreness, fatigue.  PE (+) for redness and swelling in the tonsil area and prominant cervical nodes.  Assessment:  Swollen lymph nodes, very minimal pharyngitis. Liver clinic visit 10/17/07 with DX; autoimmune hepatitis. Abnormal Liver Enzymes/Transaminitis. Rapidly improved on steroids. Behavioral Health intake 11/2/07 with c/o anxiety and depression with crying spells, feeling nervous, difficulty sleeping. DX: Adjustment d/o with anxiety and depressed mood. OV 4/30/08 with sore throat and asthma. Tonsils enlarged. Recently increased EIA. Returned 8/10/08 with continued c/o swollen glands and sore throat. Assessment Severe pharyngitis. Returned 8/13/08 No improvement on abx. L tonsil more enlarged w/ erythema. Large anterior cervical lymph nodes. Assessment: One sided tonsillitis, mono-like infection.
Pt. received Menactra vaccine on 4/15/08 and today c/o fever of 100 deg, chills and swelling (L) arm and side underneath - axilla area with redness noted.
8/14/21 reported rapid heart rate and dizziness, felt light headed, chest pain.  Lasted about 3 days. 8/15/21 complained of a spot behind right knee that was swelling and felt like a sharp painful bruise.  9/2/21 Called health department and still having a rapid heart rate. Her Dr said that a Vaers needed to be completed and if the symptoms continues that she would need to wear a Holter monitor.  Advised by her Dr  not to take second Pfizer dose. 9/15/21 Reports that at rest she is feeling better but with exertion she feels her heart racing.  the area behind her knee  is still there.
encephalitis reported in a pt who recvd fluogen in 1978; encephalitis was concurrent w/mumps; it is not certain fluogen was ever given; pt was hospitalized mumps was confirmed by serology;
AFTER RECIEVING FIRST COVID-19 VACCINE PATIENT STATED SHE FEELS HOT AND HER FACE APPEARED BRIGHT RED. PATIENT WAS GIVEN 25MG OF BENADRYL, 2 ICE PACKS AND RECOVERED IN A PRIVATE ROOM.
1st dose in 2019, 2nd never received; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 67-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in 2019).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 14-OCT-2022 Reporter's comment: Pharmacist reported that a patient received 1st dose of Shingrix in 2019 and never got the 2nd dose. The vaccine administration facility was the same as primary reporter. No other information was available. Additional Supportive Information: Till the time of reporting the patient did not receive the 2nd dose of Shingrix vaccine, which led to Incomplete course of vaccination.
Symptoms started with body aches and chills. I didn?t test positive at first. It was after a full day of symptoms when I tested positive on May 26, 2022. Since then, it?s been like a flu. It started with body aches, chills, headache, congestion, runny nose, cough. Now I?m towards the end of it. I?m on day 5. I still have a headache, tired, sinus issues. But no longer have the body aches. I had an appointment with my doctor, and she was going to prescribe Paxlovid because I was a good candidate for it. But I?m currently breast feeding, so we weren?t sure if it was safe. So I?m taking Tylenol and antibiotics to treat it.
Very large, red and purple, inflamed area on my arm with significant pain and swelling. My provider initially treated me with Keflex and told me I had cellulitis caused by the vaccine. I took the antibiotics (500mg x 3 per day) for 5 days and the area got much worse. I went back to the doctor and was told it was actually an allergic reaction. I was treated with Prednisone and Benadryl for 7 days. The area cleared up after that treatment, but is still slightly discolored.
Stomach cramps; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Stomach cramps) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Apr-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 ABDOMINAL PAIN UPPER (Stomach cramps). At the time of the report, ABDOMINAL PAIN UPPER (Stomach cramps) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment medications were reported.
On 01/03/203 I started to get a fever, cold like symptoms and headache. I tested Positive for Covid and contacted my doctor. I was prescribed Paxlovid for days and started to feel better. After testing negative for a few days I retested Positive for Covid-19 and symptoms returned.
Patient Receive First dose Moderna pt is 17 years 11 months 14 days old.
Patient's systems are swelling; mouth swelling; swelling around Patient's upper cheeks; swelling eye area; This is a spontaneous report from a non-contactable physician. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Physician reported 3 weeks post vaccine and 4 months post treatment (Mouth, cheeks, and eye area). Patient's systems were swelling and hardening of filler present. It was at its worst in the morning. It was improving around Patient's mouth but not around Patient's upper cheeks and eye area. Patient was currently taking Antihistamines. Related to [Unspecified] Juvederm, Voluma. Symptoms were still ongoing. The outcome of the event mouth swelling was recovering. The outcome of the other events was not recovered.   No follow-up attempts are needed. No further information is expected.
c/o receiving her second vaccine today and notice there was now a rash on her chest and she states she is starting to feel tingling in her throat and bilateral arms Transferred to ED. Treated with  epinephrine, solumedrol, benadryl and pepcid with resolution of symptoms
PATIENT RECEIVED INFLUENZA VACCINE AT HOSPITAL RETAIL PHARMACY. PATIENT IS EMPLOYEE OF THE HOSPITAL AND RETURNED TO SHIFT. PATIENT RESPONDED WITH MODERATE TO SEVERE ANAPHYLACTIC REACTION ABOUT 10 MINUTES AFTER ADMINISTRATION. Patient was tachypneic red in the face and chest upon arrival breathing heavily no auditory wheezing.  She does note history of asthma.  She denies any fever chills recent sick contacts or travel.  Denies any prior reaction to the flu vaccine in the past never had allergic reaction or anaphylaxis to prior influenza vaccine.  Denies any headache dizziness lightheadedness denies any chest pain.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Sep2022 at 10:00 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 64 years, in right arm  for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 with paxlovid.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300258958 same patient, different drug, different event;
I have Rheumatory arthritis and since my second shot I have had a major flare up. Five days after the shot I have developed swelling and unable to use my right arm and hand also extreme rib pain.  It has been many years since ive had such  pain.  I also have a broken heel (unheeling due to arthritis} that has become very painful
Headache & significant increase in Tinnitus both ears started 3 - 4 days after second Moderna vaccine shot.
apr90 pt vax hepta B aft human bite wound by pt w/ hepatitis. pt devel urticaria (facial). may90 pt vax 2nd hepta B. urticarial lesions worsened and persisted.  tx w/ seldane, tagamet, and prednisone.   see worm...
Pain at injection site. Nausea, redness and swelling, chills and body aches, Mild fever, headache
80 y/o female with a history of CAD by CTA 2015, hx of multiple PE's in 2015 on coumadin, PHT, HTN, HLD, GERD, CKD, and COPD who presented to the EC on 8/5 for knee pain after her legs gave out while bending down to pick up an object. Found to have a periprosthetic nondisplaced medial femoral condyle  Fracture. Also found to be positive for COVID on admission. During admission developed atrial fibrillation with RVR. On 8/13 she was RRT for tachycardia with palpitations and lightheadedness. ECG with recurrence of atrial fibrillation with diffuse ST-T abnormalities. She was started on IV amiodarone and her magnesium was supplemented with conversion back to NSR. She is stable for DC to SAR with outpatient follow-up.
Difficulty breathing while playing soft ball; Chest pains; This case was reported by a consumer via call center representative and described the occurrence of difficulty breathing in a 73-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st August 2022, the patient received the 2nd dose of Shingrix. In August 2022, less than a day after receiving Shingrix, the patient experienced difficulty breathing and chest pain. On an unknown date, the outcome of the difficulty breathing and chest pain were recovered/resolved.   It was unknown if the reporter considered the difficulty breathing and chest pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 08-AUG-2022 Reporter's Comments: On 2nd August 2022, less than 24 hours later Shingrix vaccination, the patient experienced chest pains and difficulty breathing while playing soft ball. ER (emergency room) visit required. The reporter consented to follow up. Additional Supportive Information: The partial event onset dates were captured to reflect correct time to onset.
Fatigue, Headache, Body aches for 1 day, helped with 1 gm of tylenol
5/5/18 clinic note: Pt called c/o of waking with fever and body aches. Referred to local ED. 5/5/18 outside facility note: Pt c/o of chills, malaise, general weakness; no fever. Pt was d/c b/c no emergent medical condition. Headache, Myalgia and chills, malaise, weakness.
Pt recvd DTP/OPV/HIB on 23OCT91 t103 R @ 3AM 24OCT91 when mom checked on pt, was given APAP t dec 97.7 ax @ 7AM;
Local tissue pain and swelling.  Several days of chill, fever and generalized pain and malaise.
Pt recieved 0.3 ml Pfizer vaccine in left arm (2nd dose) approximately 5 minutes later, pt c/o "itchy hives" on right hand and arm.  Pt vital obtained (BP: 132/84, HR: 80, R: 18, O2 sat: 97%).  Lungs were clear.  Pt was given 50 mg/1 ml IM Benedryl in the right arm at approximately 06:05.  Approximately 15 minutes later, pt stated she felt better and requested to go home.
Fever, Chills & Aches night of 10/24. Lasted around 12 hours but not feeling well for 3 days. On 11/5 started a rash on right lower torso. Saw MD on 11/5. Started Valtrex 1gm TID X 7D. MD diag. as diffuse shingles rash.
Chills and fever started at 2:30 AM I also had pain in my left arm and my legs it took like 14 hours before I got the symptoms. Then on January 1 I woke up I still had a fever and I was nauseated. Today January 2 I still have a slight fever and my stomach still bothers me but I can?t tell if that's from my problem I already have which I probably do.
Information has been received from a physician concerning her 12-to 15-month-old niece with a history of fever three days prior to vaccination, who in June or July 2006, was vaccinated with ProQuad (upgrade process). Two to three days after the vaccination, she developed an elevated fever of 104 degrees. She also developed seizures and meningitis-like symptoms and was hospitalized (duration and time frame not specified). At the time of the report, the patient status was not recovered. The events were considered to be disabling and the patient remains bed-ridden. It was noted that a twin brother was vaccinated with ProQuad (upgrade process) at the same time and had no problems. No additional information to report. There was no product quality complaint involved.  Additional information has been requested.
painful injection; dizzy; stomach burned; tongue felt numb; glands in throat hurt; flushed; slight headache; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number: EN9166, Expiration Date: not reported), via an unspecified route of administration, administered in right arm on 09Mar2021 at 10:45 (at the age of 70 years old) as dose 1, single for COVID-19 immunisation. The facility where the most recent COVID-19 vaccine was administered was reported to be "other". Medical history included high BP (blood pressure), high cholesterol and osteoporosis. The patient was not pregnant at the time of vaccination and prior to vaccination was not diagnosed with COVID-19. Concomitant medications included olmesartan; nifedipine; colesevelam hydrochloride (WELCHOL); ezetimibe (ZETIA) and aspirin [acetylsalicylic acid] - all taken for an unspecified indication, start and stop date were not reported. The patient previously took erythromicin (ERYTHROMYCIN), nitrofurantoin (MACRODANTIN), oxycodone (OXYCODON) and barium Sulfate contrast (IVP dye) - all taken for an unspecified indication on an unspecified date and experienced allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 09Mar2021 at 10:45, the patient experienced  painful injection, dizzy, stomach burned (as reported), tongue felt numb, glands in throat hurt (as reported), was flushed and slight headache. All events resulted to Doctor or other healthcare professional office/clinic visit. No treatment was received for the adverse events. Since vaccination, the patient has not been tested for COVID-19. Outcome of all events was recovered on an unspecified date.  No follow-up attempts are needed. No further information is expected.
Cellulitis to L thigh - lateral (posterior) VS allergic reaction to vaccine R thigh lateral (posterior). (both legs)
Swelling from upper arm to armpit and warmth within 24 hours, along with numbness in finger tips. Blistering within 36 hours, and oozing yellow/pinkish purulence after 48 hours. Resolving on day 6.
I had taken the flu shot last year 2013 and my lips became swollen. I took the shot this year to make sure it's the shot and my lips became swollen again had to take BENADRYL. My chest felt heavy when breathing.
After second dose - large swollen lymph node on neck; This is a spontaneous report from a contactable other health care professional (patient herself). A 31-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number EH9899), via an unspecified route of administration on 27Dec2020 (at the age of 31-years-old) as 1st dose single for Covid-19 immunization. The patient also received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number EK4176), via an unspecified route of administration on 30Jan2021 (at the age of 31-years-old) as 2nd dose single for covid-19 immunization. The patients medical history included allergy to amoxicillin. The patients concomitant medications included unspecified birth control medications received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. It was reported that after second dose, the patient experienced large swollen lymph node on neck on the left side, same side as injection site started on 18Jan2021 and been 2 weeks and still very large. Adverse event resulted in doctor or other healthcare professional office clinic visit. The treatment for the adverse event included an antibiotic script. The reporter assessed adverse event as non-serious with no seriousness criteria of resulting in death, Life threatening, Caused prolonged hospitalization, Disabling Incapacitating, Congenital anomaly/birth defect. The outcome of the event, large swollen lymph node on neck was not recovered.  Follow-up attempts are completed. No further information is expected.
Pain and limited range of motion in the arm that the vaccine was administered. This reaction has continued throughout the two week period since the vaccination.
a few tiny, red, raised bumps behind her knee on the right side as well as three below her knee/a few on the left/bumps are raised; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration at the age of 59-year-old on 07Apr2021 09:30 at single dose for COVID-19 immunization. Medical history and concomitant medications were none. Vaccination facility type was reported in mass event drive thru at a museum. There was no history of all previous immunizations with the Pfizer vaccine considered as suspect and no additional vaccines administered on same date of the Pfizer Suspect. There were no prior vaccinations (within 4 weeks) and no adverse event following prior vaccinations. The patient stated she received her first dose of the Pfizer BioNTech COVID-19 vaccine yesterday and is now reporting "a few tiny, red, raised bumps" behind her knee on the right side as well as three below her knee on 08Apr2021. She also mentions that she has "a few on the left" as well. Caller would like to know if this is an expected side effect with the vaccine. Spoke from the attached document to let caller know that while it did not list her specific side effects, there were reports of non-severe allergic reactions such as rash, itching, and hives following a dose of the vaccine. Referred caller to HCP for further guidance. Caller stated that she has a question. Says she got her first dose of the Covid Vaccine yesterday 07 Apr 2021 and feels fine. Says she has noticed today a few tiny red bumps behind her knee on the right side and three below her knee. States that the bumps are raised. The adverse event wasn't required a visit to emergency room or physician office. There were no relevant tests. The outcome of event was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained
losing more hair than normal; cold sores appearing randomly; inflammation of ears; inflammation of pallet randomly; pain when swallowing; pain in hands; weakness at a level 10; fever; chills; muscle pain at a level 8; very strong headache; This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (losing more hair than normal), ORAL HERPES (cold sores appearing randomly), INNER EAR INFLAMMATION (inflammation of ears), STOMATITIS (inflammation of pallet randomly) and ODYNOPHAGIA (pain when swallowing) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19.    On 14-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Mar-2021, the patient experienced HEADACHE (very strong headache). On an unknown date, the patient experienced ALOPECIA (losing more hair than normal), ORAL HERPES (cold sores appearing randomly), INNER EAR INFLAMMATION (inflammation of ears), STOMATITIS (inflammation of pallet randomly), ODYNOPHAGIA (pain when swallowing), PAIN IN EXTREMITY (pain in hands), ASTHENIA (weakness at a level 10), PYREXIA (fever), CHILLS (chills) and MYALGIA (muscle pain at a level 8). On 22-Mar-2021, HEADACHE (very strong headache) had resolved. At the time of the report, ALOPECIA (losing more hair than normal), ORAL HERPES (cold sores appearing randomly), INNER EAR INFLAMMATION (inflammation of ears), STOMATITIS (inflammation of pallet randomly), ODYNOPHAGIA (pain when swallowing), PAIN IN EXTREMITY (pain in hands), CHILLS (chills) and MYALGIA (muscle pain at a level 8) had not resolved and ASTHENIA (weakness at a level 10) and PYREXIA (fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Severe Left hip inflammation Swollen Lymph node in left arm pit slight feeling of sickness