chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Infanrix-DTaP- has tiny print necessitated by the small vial; however, it is printed in the lightest gray ink and is almost impossible to read. This should be corrected. There are many other injectables where products have labels that are not clear or companies that label many products in ways to encourage brand identification but may result in medication errors.
Mother reports high fever (104.7, severe diarrhea, and shortness of breathe four hours after vaccines.  Was seen in local ER was observed and given antibiotics to take home.  Mother states that the ER said it was probably due to the ??Rotateq.
passed out/stopped breathing for 15-20 seconds.; passed out/stopped breathing for 15-20 seconds.; Felt faint; trouble breathing; This is a spontaneous report from a contactable consumer (patient). A 40-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 2 via an unspecified route of administration, administered in left arm on 25Mar2021 11:00 (Lot Number: EN6205) as single dose for covid-19 immunisation at age 40 years old. The patient's medical history was not reported. No known allergies. No covid prior to vaccination and was not tested for covid post vaccination. Concomitant medication included loratadine (CLARITIN) taken for an unspecified indication, start and stop date were not reported. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 03Mar2021 14:00 (lot no: EN6200) in left arm for COVID-19 immunization at age 40 years old. On 25Mar2021 11:15, the patient felt faint, had trouble breathing, and passed out/stopped breathing for 15-20 seconds. The adverse events resulted in emergency room/department or urgent care. Treatment for the events included EMT monitoring onsite, saline and other meds (unspecified). The patient recovered from the event passed out/stopped breathing on 25Mar2021; while recovered from other events on an unspecified date in Mar2021.
I started having heart palpitations and racing heart. On 7/6/21 I had what I believe to be a mild heart attack. I was later diagnosed with AfIb. Before the vaccine I was very healthy. I walked 6-8 miles a day. I believe the vaccine caused my heart to fail me.
Severe fever and chills overnight, unmeasured but body noticeably hot to touch. Fever still 99.8 during next day after several hours when thermometer was acquired, but had significantly broken by that point
At 5A on 9-7-11, pt started shaking violently, Temp of 101 and nauseous - fever subsided at 1P.
AE: feeling hot and sweaty( at 03:20pm) Treatment: no medication was given. patient was under observation.  hydration with orange juice improved symptoms Outcome: symptoms resolved and patient was sent to POV/Home.
Fatigued; Short of breath, felt worse through the night; Got up 8 to 10 times in the night to urinate; This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 57-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16th March 2022, the patient received Shingrix. On 16th March 2022, less than a day after receiving Shingrix, the patient experienced fatigue, shortness of breath and increased urinary frequency. On an unknown date, the outcome of the fatigue and shortness of breath were not recovered/not resolved and the outcome of the increased urinary frequency was unknown.   It was unknown if the reporter considered the fatigue, shortness of breath and increased urinary frequency to be related to Shingrix.  Additional details were reported as follows: The case was self reported by the patient. The reporter stated that he received a dose of the Shingrix vaccine a day before reporting.  The reporter stated that during evening (on the day of vaccination) he had felt fatigued and short of breath (adverse event) and felt worse through the night.  The reporter stated that he got up 8 to 10 times during the night to urinate (adverse event). The reporter inquired if these side effects were normal. The reporter prematurely disconnected call. No additional details were provided by the reporter. The reporter did not consent to follow up.
This is a spontaneous report from a contactable Nurse via Pfizer sales representative. This nurse reported similar events for two patient. This is the second of two reports. A male patient of an unspecified age and ethnicity received TRUMENBA, via an unspecified route of administration at single dose on an unspecified date. The patient medical history and concomitant medications were not reported. The patient experienced low grade fever and aches on an unspecified date with outcome of unknown. Follow-up (29JUL2016): Follow-up attempts are completed. No further information is expected.
On 2/16/21 I suffered an occlusive stroke. No health problems. No prescriptions meds. BP was always around 120/70's. Height: 5'4", Weight: 126 lbs. All blood work within normal range No high chlolestrol, etc. I was scheduled for 2nd vaccine on 3/1, I was advised to reschedule, which I did for 3/23. I spoke to a coule of health care professionals and asked them if they would proceed with the 2nd vaccine if it were them and was told "no". I am very afraid to get the 2nd vaccine. I would like to discuss this with someone.
PATIENT BECAME DIZZY, FLUSHED AND SLIGHTLY RED ON ARM AT SITE. GIVEN 25 MG BNENDRYL. SYMPTOMS RESOLVED WITHIN 30 ADDITIONAL MINUTES .
Pt recvd MMR vax 9NOV91 & on 13NOV exp sore arm, lethargic; 15NOV tired achy, inc temp 102; 17NOV arm immobile, red, swollen elbow, pain now also to chest area, pt started on ATB; 18NOV adm to hosp dx cellulitis;
3/27/2021   Patient was observed post Covid-19 immunization for 30 minutes based on pre-vaccination screening .  During the observation period, she experienced an adverse reaction with the following symptoms:  swelling of face and throat.   Assessment : Time of assessment 1130am, no visual redness, rash or swelling of face or mouth, tongue           Actions taken:  *1130am*Alert and oriented. Benadryl 25 mg po x1 given, VS checked with BP- 132/84, P- 84, O2- 98%, 1201pm VS rechecked BP- 119/73, P- 77, O2- 98%, monitored for 30 minutes.       There were no vitals filed for this visit.   Medications administered: Diphenhydramine (Benadryl) 25 mg capsule, by mouth. Time: 1130. Administered by rn.   Disposition: Reports no further symptoms of adverse reaction after observation for 30 minutes. Discharged home.     Immunizations Administered    Name Date Dose VIS Date Route   Moderna COVID-19 Vaccine 3/27/2021 11:03 AM 0.5 mL 12/1/2020 Intramuscular   Manufacturer: Moderna
Large red circle surrounding vaccination site. Warm to the touch. First noticed about one week after vaccination.
Patient was 3 months old and received 0.25 mL dose of Influenza vaccine.
spasms of the opposite arm; rapid increase of blood pressure; extra dose of FLUZONE QIV MDV being administered to a patient; Initial information received on 13-Oct-2021 regarding an unsolicited valid non-serious case received from an other health professional via agency (under the reference 00810876).  This case involves a 45 years old female patient had spasms of the opposite arm (muscle spasms) and rapid increase of blood pressure (blood pressure increased) after receiving extra dose of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE] (extra dose administered).  The patient's past vaccination(s) included FLUZONE QUADRIVALENT with once had a previous dose on 27-SEP-2021 (0.5 ml, total) for prophylactic vaccination.   The patient's medical history, medical treatment(s), concomitant medication(s) and family history were not provided.  On 12-Oct-2021, the patient received a second dose of suspect FLUZONE (0.5 ml, total, once, lot UJ705AB and expiration date not provided) via intramuscular route in the left deltoid for prophylactic vaccination.  On 12-OCT-2021 the patient developed a non-serious spasms of the opposite arm (muscle spasms) and rapid increase of blood pressure (blood pressure increased), same day following the administration of vaccine.  It was an actual medication error due to extra dose administered (same day latency)  No laboratory data reported.  It was reported "Nurse calling in regards to a extra dose of FLUZONE QIV MDV being administered to a patient. Nurse would like to know which adverse events to look out for in the patient? Patient received a second dose of the flu vaccine at a doctors office, patient did seem to exhibit adverse reactions and was transported to the ER (emergency room) where they were treated and discharged"  An unknown corrective treatment was received for the events.  At time of reporting, the outcome was Unknown for the events.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Fever, swelling, generalized pain, inflammation of vaccination site, pt to return in 24 hr for evaluation.
pt presented on 12SEP96 c/o swelling pain L 6/M x 24hr;eval by MD dx w/cellulitis, rxn to inj-pt placed on 10 day course of ATB;
Initial mild fatigue day 2 & 3 followed by abdominal pain day 3.  Accute Appendicitis, followed by surgery to remove appendix
Rapid heart rate from 11:00PM until 1:10PM when I went to bed. Recorded heart rate above 140 to 151 consistantly for 2 hours, occasionally irregular. Went to bed, awoke at 8:30 AM, heart rate was regular again.
Roughly 90 minutes after my vaccination my left eye got itchy and swollen; Roughly 90 minutes after my vaccination my left eye got itchy and swollen. Both the eye itself and the area around the eye swelled; the eye was still a bit puffy and swollen; This is a spontaneous report from a contactable healthcare professional (patient herself). A 25-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL8983; expiry date: unknown) via an unspecified route of administration in the left arm, on 22Jan2021 at 17:00, at a single dose, for COVID-19 immunization. The patient has no relevant medical history. Concomitant medications included vitamin B complex (VITAMIN B), colecalciferol (VITAMIN D), and loratadine (CLARITIN) and unspecified birth control (BC) pills. The patient previously received codeine and experienced allergy. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in the hospital. On 22Jan2021, roughly 90 minutes after vaccination (at 18:30) the patient's left eye got itchy and swollen. Both eyes and the area around the eye swelled. It went down upon icing and taking two over the counter Benadryl. However, the next morning, the eye was still a bit puffy and swollen. The events were considered non-serious. Outcome of the events was recovering. The patient has not been tested for COVID-19 since vaccination.
Information has been received from a doctor of pharmacy concerning a pt who, post vax, subsequently, developed hemolytic anemia, which was considered to be an other medical event. The pt sought unspecified medical attention. Additional information has been requested. Follow-up information from a doctor of pharmacy indicated that the physician stated he never had a pt who developed hemolytic anemia after receiving pneumococcal vaccine 23 polyvalent.
Our office had a temperature excursion as per the department of health we have to submit this to VAERS, As per patient no adverse side affect on vaccine date till present day.
a customer got dizzy when in a chair for several minutes after getting covid shot. He said he got dizzy, had blurred vision, and his back hurt. He was helped up and 991 was called while I sat with him. 911 asked him questions. he refused help and followed him out. He stated he never had problems with vaccines before.
Instantly had a Metal taste in mouth and buzzing tongue. Later I had a very sore arm and throat. Then the next day I had a headache, upset stomach, chills and a was achy.
Father of patient noticed hives on left upper arm and bilateral thighs. Patient was seen by provider and was given 2.5 mL of Benadryl.
Swelling of right underarm lymph nodes started approximately 2-3 hours after injection; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old male patient received BNT162b2 (BNT162B2), on 05Nov2021 at 10:00 as dose 3 (booster), single (Lot number: FG3527) at the age of 62 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "heart surgery to remove tumor" (unspecified if ongoing); "heart surgery to remove tumor" (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL; ATORVASTATIN. Past drug history included: Ampicillin, reaction(s): "known allergies: Ampicillin". Vaccination history included: BNT162b2 (previous dose details , prev dose product=COVID 19,, prev dose brand=Pfizer,, prev dose brand unknown=False,, prev dose lot number=EN6204,, prev dose lot unknown=False,, prev dose administration date=21Apr2021,, prev dose administration time=12:00 PM, prev dose dose number=2,, prev dose vaccine location=Right arm,), administration date: 21Apr2021, when the patient was 61-year-old, for Covid-19 immunization; BNT162b2 (prev  dose product=COVID 19,, prev dose brand=Pfizer,, prev dose brand unknown=False,, prev dose lot number=EN6203,, prev dose lot unknown=False,, prev dose administration date=31Mar2021,, prev dose administration time=12:00 PM, prev dose dose number=1,, prev dose vaccine location=Right arm), administration date: 31Mar2021, when the patient was 61-year-old, for Covid-19 immunization. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 05Nov2021 at 14:00, outcome "not recovered", described as "Swelling of right underarm lymph nodes started approximately 2-3 hours after injection". The event "swelling of right underarm lymph nodes started approximately 2-3 hours after injection" required physician office visit. Therapeutic measures were not taken as a result of lymphadenopathy.  Additional information: Adverse event: Swelling of right underarm lymph nodes started approximately 2-3 hours after injection. Left-arm lymph nodes also swelled roughly 2 months later, but have reduced. Right arm is still swollen today, but not as much as before.
Information has been received from a registered nurse concerning a 21 year old male with environmental allergies who was vaccinated with a first, second, and third dose of MMR II, in September 1991, July 1992 and on 10/25/01 with lot (638163/0156L. Subsequently the pt failed to seroconvert for rubeola and had an equivocal titer for mumps. Unspecified medical attention was sought. Additional info has been requested.
fever 104, vomiting, diarrhea, lethargic, fuzzy;
Anxiety; Insomnia; Psychiatric issues; Vaccine exposure during pregnancy; This is a spontaneous case initially received from other non-health professional (consumer) via Company (reference number: SEQW20-00043) on 03-Mar-2020, concerning an adult, female, pregnant patient.  The patient's medical history included pregnancy with advanced maternal age.   The patient's concomitant medications were not reported.  The patient's obstetrical history was not provided.   The patient's last menstrual period (LMP) date, estimated delivery date (EDD), corrected estimated date of delivery (CEDD) and type of pregnancy were not reported.  On an unknown date in Sep-2016, during the end of her first trimester of pregnancy, the patient was administered unspecified flu vaccine, reported as Afluria (unknown if TIV or QIV) [Influenza virus vaccine polyvalent; dose, route of administration, anatomical location, batch number and expiration date: not reported] (explicitly coded as Vaccine exposure during pregnancy') for protection against seasonal influenza. It was her first and only vaccine she had ever received.   On an unknown day in Oct-2016, about one month later, the patient developed some psychiatric issues, such as severe insomnia and anxiety.   The patient stated that her pregnancy was uneventful, and she soon returned to her normal self.  At the time of this report, the outcome of all events was resolved.  The reporter assessed the case as non-serious.   The reporter did not provide causality assessment.  Company comment:The pregnant patient developed anxiety, insomnia and mental disorder, about one month after vaccination with the suspect product, Afluria. (explicitly coded as Vaccine exposure during pregnancy'). Chronology is unsuggestive. No information about concomitant medications was provided. Based on provided information, causal relationship between the suspect product and the events of anxiety, insomnia and mental disorder is assessed as unlikely related (defaults to "related" in the safety database for reporting purposes), while for vaccine exposure during pregnancy as not related per company conventions.; Sender's Comments: The pregnant patient developed anxiety, insomnia and mental disorder, about one month after vaccination with the suspect product, Afluria. (explicitly coded as Vaccine exposure during pregnancy'). Chronology is unsuggestive. No information about concomitant medications was provided. Based on provided information, causal relationship between the suspect product and the events of anxiety, insomnia and mental disorder is assessed as unlikely related (defaults to "related" in the safety database for reporting purposes), while for vaccine exposure during pregnancy as not related per company conventions.
Pt received first dose of PPV 23 in 2004 and experienced some erythema at injection site.  Was told by MD to get PPV 23 #2. NKA.  Administered LA IM 7/20/10.  Called and said her arm was sore and was not relieved by ice or ADVIL.  Came to Health Dept - left upper arm distal from injection -> elbow swollen and warm to touch - erythema (sl) noticed.  Asked Pt to contact MD and to let health dept know of her status.
Nausea; Hives; Headache; Swollen eye lids; Body aches; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF2588) via an unspecified route of administration in the left arm on 11Oct2021 at 09:15 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history included epilepsy seizure disorder. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included lamotrigine (MANUFACTURER UNKNOWN), folic acid (MANUFACTURER UNKNOWN) and cyanocobalamin (VIT B12); all for unknown indication from an unknown date and unknown if ongoing. On 11Oct2021 at 09:30, the patient experienced nausea, hives, headache, bodyaches and swollen eyelids. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events reported. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events swollen eye lids, nausea, hives, headache and body aches was resolved with sequelae on an unknown date in Oct2021.
currently has a respiratory cough; not an infection or pneumonia; just a cough; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A patient in their 90's received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) 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 Immunisation; Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for COVID-19 Immunisation. The following information was reported: COUGH (non-serious), outcome "unknown", described as "currently has a respiratory cough; not an infection or pneumonia; just a cough".  Additional information: The caller had a question about whether there is any advice or risk for older adults if there's a timeframe for getting the 4th booster dose of Pfizer Covid-19 Vaccine. She explained let's say that a person in their 90s who currently has a respiratory cough; not an infection or pneumonia; just a cough-Is there a time frame that it is best to get or not get the 4th booster dose of Pfizer Covid-19 Vaccine.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient awoke 4/9/16 (Saturday am) to find right neck swelling (soft and non tender) that resembled the "mumps." Denied any associated pain, redness, rash, itching, fever, difficulty breathing, difficulty with speech or any pain with movement. Swelling stable today - no worse. Patient did not seek medical evaluation for complaint. Went to schedule school classes this am without incident.
On 1/13, she developed low back pain.  8-9 days later, she woke up with bilateral leg numbness and tingling with weakness from hips to feet. She was admitted to the hospital where she had an MRI of her brain, complete spine that showed enhancement of the grey matter of the spinal cord in the optic radiations, brain stem, cervical-thoracic spinal cord. She was diagnosed with presumed acute flaccid myelitis. She received IVIG inpatient with improvement of symptoms.
Developed Erythema multiforme, without systemic signs on 8/17/02, 5 days after DtaP (only)
4/30/98 rec'd varicella immunization. 4/22/02 seen at medical services by MD with rash to trunk and abdomen, denied nausea, vomiting, fever or cold symptoms. Dx: chicken pox.
- Felt weak and light headed after receiving vaccine, continued to feel weak up until 07/12/21. ( Least of problems ) - Feb. 22 begin to lose hearing in my right ear ( Went to see an ENT ) found to be deaf  - Recovered some hearing 2-3 days later - Started bleeding from lower GI tract 03/2021 went to hospital 03/06/21 lost 1/3 of blood, spent 4 days in hospital  - I Assumed the bleeding was trigged by the vaccination
Information has been received from a medical assistant referring to multiple unknown patients of unknown age and gender. The patients' pertinent medical history, concurrent conditions or drug reactions/allergies were not provided. They were vaccinated with improperly stored GARDASIL 9 (lot # M003659, expiration date 20-SEP-2017, dose and route not provided) or ROTATEQ (lot # L038534, expiration date 19-AUG-2017, dose and route not provided) on multiple unknown dates (Incorrect product storage). Co-suspect therapies or concomitant medications were not provided. No adverse effects were reported. Temperature: 47F. Time frame: 120 hours. Was it administered (AE): Yes. Previous temperature excursion: No. Was call because of a "data logger": No. Additional information has been requested.