chrisvoncsefalvay/vaers-outcomes huggingface dataset:
her blood sugar is going below to 90; This is a spontaneous report from a contactable consumer. A female patient received BNT162B2 on unknown date (reported as Tuesday) single dose for COVID-19 immunization.  Medical history was not provided. Concomitant drug included ongoing insulin pump. The patient reported her blood sugar was going below to 90. The outcome of the event was unknown.  Information about lot/batch number has been requested.
Whole arm swelled 2 days after injection. 3" below injection sight had severe knot and 2" redness and hot temperatures. Upper arm very tender to slightest touch. Arm was itchy. Low grade fever under control with proper dosage of ibuprofen 3 times a day.
Moderna COVID-19 Vaccine EUE Painful swelling under the arms began to be increasing uncomfortable about 27 hours after the administration of the vaccine and was markedly painful and swollen for the next 72 hours.  Pain and swelling has decreased slightly but still exists at time of this report.
got Covid; got Covid; This is a spontaneous report received from a contactable reporter(s) (Physician).  A child patient received BNT162b2 (BNT162B2), on 11Nov2021 as dose 1 (orange cap), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2021, outcome "unknown" and all described as "got Covid". Clinical course: Caller is a Pediatrician, asking regarding 3 patients ages 5-9 years of age, for the Pfizer Covid-19 vaccine Orange cap, 3 patients received the 1st Primary Dose on 11Nov2021, 2 weeks later they got Covid, and never got the 2nd primary series dose after that. On 11Nov2022, these 3 patients received a primary dose of the Pfizer Covid-19 vaccine Orange cap, caller is asking if it is considered as a 2nd dose or need to repeat the doses.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The reported COVID-19 positive 2 weeks(14 days) after dose 1 BNT162b2 is considered ineffective of BNT162B2, and the Company cannot completely exclude the possible causality between the reported events and BNT162B2 administration.,Linked Report(s) : US-PFIZER INC-PV202200103524 Same reporter/Drug/AE, different patient;US-PFIZER INC-PV202200103528 Same reporter/drug/AE, different patient.;
Wheezing, coughing; Shortness of breath; Nausea; Lightheadedness.
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 13-MAR-2018, the patient was vaccinated with PEDVAXHIB lot number N003700 with expiration date on 01-NOV-2019 (strength, dose, route of administration and anatomical location were not reported) for prophylaxis. The administered dose of the vaccine experienced a temperature excursion in the range between 32°F up to 35°F for 270 minutes and 47°F to 77°F for 75 minutes, as recorded by a data logger. The vaccine had not had any previous temperature excursions. There was no adverse effect reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1805USA003078.
This case was reported by a consumer via call center representative and described the occurrence of chills in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a day after receiving SHINGRIX, the patient experienced chills, fever, muscle pain, joint pain and sickness. On an unknown date, the outcome of the chills, fever, muscle pain, joint pain and sickness were unknown. It was unknown if the reporter considered the chills, fever, muscle pain, joint pain and sickness to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The age group was not provided, but was selected adult as per the vaccine indication. The patient received the SHINGRIX few months ago and within 5 or 6 hours the patient was sick as a dog, temperature, chills, muscle aches, joint pain. The patient talked with the pharmacist and they decided and picked up a bug while wandering through the store. There was no way the patient had a reaction to the shot, it just was not possible. For tolerance of 2nd dose, refer case US2019GSK056824.
12MAR93 nausea, fever of 103 oral, swelling, redness in lt arms, tingling hot & cold in elbow, chilling; 13MAR93 to ER for some sx & given inject of DPH, oral Pred & given rx for Pred; lt arm tender, red & blotchy;
COVID vaccine Breakthrough case. Boosted, Moderna 030A21A on 03/23/2021 and Moderna 004M20A on 02/15/2021. Booster Moderna 939904 on 10/27/2021.
Immunizations given in office 3/11/03 approx 10:30 AM. Child taken to ER about 103.5 temp; right thigh slightly red on 3/12/03 at 12:09 AM Ibuprofen given. Temp down to 100.6 right before leaving. Only slight fever 100 degrees 3/12/03 all day.
Irregular menstrual cycle. Breakthrough bleeding/spotting starting 3 days after vaccine.  Bleeding comes intermittently & is randomly heavy then stops. Seems like I?m on my period every 2 hours or so. Not due for the start of period for 1.5 weeks from today. Usually VERY regular and have never once had spotting before. 0% chance of pregnancy at the time of vaccine or currently.
Tonic clonic seizure; This is a spontaneous report from a contactable physician. A 41-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date unknown), via an unspecified route of administration on 01Feb2021 14:00 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced tonic clonic seizure on 01Feb2021, the same day. The patient received the dose at 14:00 and had the seizure around 19:00. Patient has recovered from the event on an unspecified date. No treatment was received for the event.   Information about lot/batch number has been requested.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported tonic clonic seizure and the administration of the COVID-19 vaccine, BNT162B2, based on the reasonable temporal association and lacking alternative explanations.   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 RA, IEC, as appropriate.
G62.9 PERIPHERAL NEUROPATHY 4/6/2023 UPPER GI HEMORRHAGE G62.9 PERIPHERAL NEUROPATHY 4/6/2023 ANEMIA G62.9 PERIPHERAL NEUROPATHY 4/6/2023 HTN (HYPERTENSION) G62.9 PERIPHERAL NEUROPATHY 4/6/2023 HTN (HYPERTENSION) G62.9 PERIPHERAL NEUROPATHY 4/6/2023 ANEMIA
Injection site tenderness; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 1261) via an unspecified route of administration in the right arm on 13May2021 at 09:15 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history included borderline personality disorder and sleep apnea. Concomitant medications included desvenlafaxine succinate monohydrate (PRISTIQ), quetiapine fumarate (SEROQUEL XR) and zolpidem tartrate (AMBIEN) all for unspecified indications from an unknown date. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 1261) via an unspecified route of administration in the left arm on 22Apr2021 at 09:30 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 13May2021, at 14:30 the patient experienced injection site tenderness. The event 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 event. The clinical outcome of the event injection site tenderness was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Pt noted a sore tongue following the first shot and then symptoms resolved after 2 days. Then following the second shot had a sore tongue which has lasted 2 months.  Has now developed slight tingling of the lips.
Patient called on Saturday morning June 5 advised that he had tested positive for COVID-19 results came back that day. Patient received his second dose of the Madrona vaccine in April on May 26 he began feeling sick with a temperature of 100.3 body aches and pleuritic chest pain by Friday his  fever was gone. He got tested for Covid 19 with the PCR nasal swab 2 or 3 days prior and the results returned on Saturday patient remains afebrile and is minimally symptomatic Saturday, June 5 was 10 days from symptom onset patient was advised that at this point since he feels better and is afebrile he does not have to remain in strict isolation his information will be forwarded to the facility
Immediately  felt dizziness, shortness of breathe and left body numbness. Fainted in and out and left body tightness/pain for 2 hours post injection.  fever, fatigue, headache, shortness of breathe, muscle fatigue, chest ache for several days after.  01/08/2021 all symptoms become worse and severe. Left body muscle tightness and fatigue, heart palpations, vomiting, chest pain, dizziness, syncope, difficult breathing, unable to walk.  ER Visit 01/08/21, 01/09/21, 01/09/21, and 01/11/21 PCP visit 01/12/21 Cardiologist visit 01/15/21
101.4 temp; Headache; Achy; This is a spontaneous report received from a contactable consumer, the patient. A 61-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: EN6201, Dose number: 2) via an unspecified route, administration in the left arm on 17Mar2021 at 13:00 as 2nd dose single for COVID-19 immunization. Medical history and concomitant were not reported. The patient previously received BNT162B2 (lot: EL9264) in the arm on 22Feb2021 as a first dose for COVID-19 immunisation. The patient had 101.4 (unspecified units) body temperature increased, headache and achy on 17Mar2021 14:00. It was unknown whether the patient received therapeutic measures for the event. The clinical outcome of body temperature increased, headache and ache were unknown at the time of this report. No follow-up attempts are possible. No further information is expected.
I just felt real tired; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (I just felt real tired) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023H20A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Sep-2021, the patient experienced FATIGUE (I just felt real tired). At the time of the report, FATIGUE (I just felt real tired) outcome was unknown.            No concomitant medications were reported.  No treatment medications were reported.
fatigue; difficulty swallowing.; allergic reaction; chest pain; shortness of breath; not feeling good; Weakness in Lower half of body; Difficulty breathing, brain is foggy, swelling in throat, excessive sweating, puffy face,having difficulty talking and her face became puffy; Feverish; This spontaneous case was reported by a consumer and describes the occurrence of ANAPHYLACTIC REACTION (Difficulty breathing, brain is foggy, swelling in throat, excessive sweating, puffy face,having difficulty talking and her face became puffy), CHEST PAIN (chest pain), DYSPNOEA (shortness of breath) and FEELING ABNORMAL (not feeling good) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history). Concomitant products included ISOTRETINOIN (ACCUTANE) and ESCITALOPRAM OXALATE (LEXAPRO) for an unknown indication.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced ANAPHYLACTIC REACTION (Difficulty breathing, brain is foggy, swelling in throat, excessive sweating, puffy face,having difficulty talking and her face became puffy) (seriousness criteria medically significant and life threatening), MUSCULAR WEAKNESS (Weakness in Lower half of body) and PYREXIA (Feverish). On 21-Jan-2021, the patient experienced CHEST PAIN (chest pain) (seriousness criterion medically significant), DYSPNOEA (shortness of breath) (seriousness criterion medically significant), FEELING ABNORMAL (not feeling good) (seriousness criterion medically significant) and HYPERSENSITIVITY (allergic reaction). On 22-Jan-2021, the patient experienced DYSPHAGIA (difficulty swallowing.). On an unknown date, the patient experienced FATIGUE (fatigue). At the time of the report, ANAPHYLACTIC REACTION (Difficulty breathing, brain is foggy, swelling in throat, excessive sweating, puffy face,having difficulty talking and her face became puffy), CHEST PAIN (chest pain), DYSPNOEA (shortness of breath), FEELING ABNORMAL (not feeling good), MUSCULAR WEAKNESS (Weakness in Lower half of body), HYPERSENSITIVITY (allergic reaction), DYSPHAGIA (difficulty swallowing.), FATIGUE (fatigue) and PYREXIA (Feverish) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product included birth control. Treatment information included anti nausea pills, aspirin, epiPen, benadryl, tylenol, injection for breathing and surmonside.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Inadvertent administration.  Patient<16 y/o.  No negative outcome or severe adverse events
Patients states it felt like an inflating balloon and hurt when it was injected. She experienced pain immediately and pain has continued and gotten worse. She can't sleep on the arm, has a hard time dressing and driving. She also needs to type for her job and has a hard time doing that.
Patient's heart rate increased into the 110 to 120 range for weeks. She  experienced a shooting pain across her chest and became dizzy. Patient went to the Emergency Department.
pt recvd vax 14DEC93 that evening when taking off bandage noted red itchy spot about the size of a nickel; area has gradually gotten longer to about 3" x 5" of red, itchy area w/smalll induration in center;
This spontaneous report as received from a medical assistant refers to mulitple unspecified patients of unknown age/gender. The patients' concurrent or historical conditions were not provided. Concomitant therapies were not reported. On an unknown date the patients were vaccinated with improperly stored GARDASIL (dose, lot number, route and frequency were not reported). No adverse effects were reported and no product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
beginning around 8pm on 1/20/21 (day of vaccine), chills. woke up around 2am on 1/21/21 with nausea, feeling warm -- temp of 100.7; chills, fever, and nausea all morning of 1/21/21; fever and chills continued through 1/22/21 around 11am. Treated with Tylenol and Zofran.   On 1/22/21 noticed lymph node swelling on arm where vaccine given. Neuropathy 1/22/21. Treated wtih ibuprofen 600mg TID. Lymph node remains swollen as of 1/25/21. Lymph node is hard.
This spontaneous report as received from an office manager refers to a 4 year old patient of unknown gender. His/her medical history, concurrent conditions and concomitant medications were not reported. On 13-MAY-2014, the patient was vaccinated with a dose of ZOSTAVAX (0.5 ml, subcutaneously, lot # J012661, expiration date 10-JAN-2015). No adverse effects were reported. Additional information has been requested.
Later that evening he got a fever as high as 102.7, the following morning it was 102.4 and had bad body aches throughout the whole body, he was unable to move his body due to the pain, the mother call ER and they told her to call the Pharmacy and the pharmacy said to take ibuprofen and Tylenol, that night he just sweat out  the fever,  He also had shortness of breath
Mild-Moderate headache. Moderate-Severe muscle pain in upper back, shoulders, neck and shoulders. Mild swelling/pain in lymph nodes, both sides - face, neck, arms. Experienced fatigue and arm soreness for 2-3 days after vaccination, which I understand is normal and a good sign that my immune system is responding to the vaccine.   However, then my neck and back muscles started to get really tight and tender, this has continued for over 5 days now and is not improving yet. I'm toughing it out, and trying to treat with rest, massage, and heat/cold. Will be trying a muscle relaxer prescribed by my neurologist tonight.
11-9-00 HV; ? 1990-91 Reaction to  with cardiac catherization; PMD appt. 11-13-00-routine visit; 'I'm not worried about the bruising at all, I always bruise easily so that nothing to be concerned about"; swelling gone; reports arms and shoulders always hurt secondary to arthritis; called HD 11/6/00 and told to call MD by the PHN. unable to reach and later contact by "women in Fred." copy to CHD NSG  supervisor. Original to FHD
MOC co sleeping with infant.  Previously well.  Previously seen 40 minutes prior to event.  Found unresponsive, blood coming out of nostrils.  EMS called.   EMS arrived, CPR, asystole.   Present to Hospital, 7/24/2022 at 03:12 not responsive, cyanotic on arrival.   Coded.  7 doses of EPI
Shortly after admin of Zostivax, pt felt malaise since then.  She has shingle outbreak on right side of side and hip area & back of neck.
Jerking movement were to hands when observed during med pass.  Tonic clonic movements were assessed for approximately 2 minutes. Code called and patient sent to ER via 911 No history of Seizures she has ongoing seizures. there is a significant decline in her mental status. She is not speaking. She has to be fed. She is not walking.. She is scheduled to see a neurologist in June 2021.
Female vaccinated with GARDASIL.  Shortly after she developed Colitis, inflammatory bowel disease, an autoimmune disease.  12/18/09 MR received for DOS 12/31/08. Chief complaint: Hematochezia. Pt c/o bright red stool in the stool.  Pt reported 3 bowel movements per day. System review negative. Rectal exam revealed no hemorrhoids. Tx: imiquimod topical.  MR for DOS 07/28/09. Pt reported DX of Colitis given by the GI specialist. Pt had reoccurrence of blood in stool.  Pt treated with Omeprazole, prednisone, imiquimod topical.  MR for DOS 08/06/09. Pt started Asacol per GI specialist. MR for DOS 10/26/09. DX: Ulcerative colitis. Physician discussed with Pt possible relation of HPV vaccine to this event, but stated that likely no causal link will ever be established. Pt counseled about the risk of cervical cancer and importance of routine screening. Tx: Mesalamine.
IUI complete 3/9/21, first vaccine given 3/17/21, positive pregnancy test 3/24/21, second vaccine 4/7/21(side effects- body aches and menstrual cramps worse than starting a cycle, initial ultra sound 4/14/21- egg sack only measuring at 6 weeks size(which is when second vaccine was receive) and low heart rate, 4/26/21 growth scan- egg did not grow any further and no heart rate.
Immediately after injection patient was light headed, became nauseous. He never lost consciousness. He started to get better after about 15 minutes, but was clammy. I checked his BP which was low, slightly above 90/60 and pulse registered as low. EMS was called to check him out. He was cleared and it is thought that it is a stress reaction.
Pt vaccinated with DTP/OPV/HIB developed prolonged screaming, hyperactive, couldn't focus eyes for 3 days, temp 100.2, inject site looks good.
COVID tongue. Reaction is on the tip, left side of the tongue about an inch in length. Seemed to heal, but still had a dent in the side of tongue from the reaction; COVID tongue/ Feels and looks like a bad burn with pealing and bumps; COVID tongue/ Feels and looks like a bad burn with pealing and bumps; Pregnant at the time of vaccination?: Yes/ Gestation period: 35 weeks; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 27 year-old female patient (pregnant) received bnt162b2 (BNT162B2), administration date 09Sep2021 (Lot number: FE3592) at the age of 27 years as dose 1, single and administration date 30Sep2021 (Lot number: FF2589) as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient was 35 weeks pregnant at the event onset. Concomitant medication(s) included: TDAP taken for immunisation, start date: 09Sep2021, stop date: 09Sep2021. The following information was reported: MATERNAL EXPOSURE DURING PREGNANCY (non-serious) with onset 09Sep2021, outcome "unknown", described as "Pregnant at the time of vaccination?: Yes/ Gestation period: 35 weeks"; TONGUE DISORDER (non-serious) with onset 10Sep2021, outcome "recovering", described as "COVID tongue. Reaction is on the tip, left side of the tongue about an inch in length. Seemed to heal, but still had a dent in the side of tongue from the reaction"; TONGUE EXFOLIATION (non-serious), TONGUE DISORDER (non-serious) all with onset 10Sep2021, outcome "recovering" and all described as "COVID tongue/ Feels and looks like a bad burn with pealing and bumps". Therapeutic measures were not taken as a result of tongue disorder, tongue exfoliation, tongue disorder.  Additional information: The Patient received concomitant medications taken within two weeks of vaccination included shaklee women vitamin supplements for unspecified indication from an unknown date and unknown if ongoing. The reaction occurred 24-48 hours after first shot and lasted a few weeks. reaction was on the tip, left side of the tongue about an inch in length. It seemed to heal, but still had a dent in the side of tongue from the reaction. the same thing had happened with the second dose or shot in the same spot of the tongue, symptoms started 24-48 hours after second shot and had lasted at least a week till the time of report. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for covid-19. The patient had no medical history and no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19.  No follow-up attempts are possible. No further information is expected.