chrisvoncsefalvay/vaers-outcomes huggingface dataset:
About 5 minutes after receiving Prevnar 20, Patient felt light headed, blurry vision, difficulty of breathing and swelling of the throat. She self injected one dose of Epipen. The conditions are improving and she said that "she's feeling better." About 7 minutes later, she complained that the swelling of her throat was getting worse and loosing consciousness, I immediately injected one dose of epinephrine 0.3mg intramuscularly. She regained her consciousness and started talking. About 10 minutes latter, she suddenly collapsed into my arm and showed signs of difficulty of breathing. Her conditions were getting worse quickly, so I administered one more dose of epinephrine 0.3mg. She regained her consciousness
On 14SEP2021, I went to pharmacy for my second dose of the Pfizer COVID-19 vaccination.  A few minutes following my second COVID-19 vaccination I became woozy, my vision became blurred and spotty, I had an  immediate fever, and sweating.  The pharmacy put cold compresses on me and I immediately took 2 Tylenol to bring down  my fever (side effects lasted approximately 15 minutes).   At the time of my second vaccination, it is unknown if I was pregnant since I would have only been a few weeks far long (too soon for pregnancy test).  Menstrual  period began two days later and was abnormally heavy with large clots (period was a week early).
Myalgia, Arthralgia, Fatigue and Chills Narrative:  Other Relevant History:
pt recvd flu vax & pt devel low grade fever, malaise, runny nose & cough;
Fever; aches and pains; headache; This is a spontaneous report from a contactable consumer (patient). A 51-year-old non-pregnant female patient received second dose of BNT162B2 (brand=Pfizer), via an unspecified route of administration (right arm) on 02Feb2021 08:30 at a single dose for COVID-19 immunization at a workplace clinic. Medical history included allergies to macadamia nuts. There were no concomitant medications. No other medications the patient received within 2 weeks of vaccination. Historical vaccine included first dose of BNT162B2 (brand=Pfizer) on 14Jan2021 07:30 AM (vaccine location= left arm). 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 experienced fever, aches and pains, headache on 03Feb2021 05:00 AM. No treatment received for the events. The events were reported as non-serious (did not result to death, not life threatening, did not cause/prolong hospitalization, not disabling/incapacitating, and not congenital anomaly/birth defect). Since the vaccination, the patient has not been tested for COVID-19.  Information on the lot/batch number has been requested.
arm sore; body aches; chills; night sweats; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 04Mar2021 11:15 (Batch/Lot number: unknown) at the age of 68 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "High BP" (unspecified if ongoing); "thyroid" (unspecified if ongoing); "Penicillin" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN; LEVOTHYROXINE SODIUM; AMLODIPINE BESILATE; ASPIRIN (E.C.). The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 05Apr2021, outcome "not recovered", described as "arm sore"; PAIN (non-serious) with onset 05Apr2021, outcome "not recovered", described as "body aches"; CHILLS (non-serious) with onset 05Apr2021, outcome "not recovered", described as "chills"; NIGHT SWEATS (non-serious) with onset 05Apr2021, outcome "not recovered", described as "night sweats". The events "arm sore", "body aches", "chills" and "night sweats" were evaluated at the physician office visit and emergency room visit. Therapeutic measures were taken as a result of pain in extremity, pain, chills, night sweats.  Additional information: Patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. Treatment (Pain meds, muscle relaxer, MRI requested) was received for the adverse event. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient not tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Muscle pain left arm injection site; A spontaneous report was received from a consumer concerning a 35-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and muscle pain in left arm at injection site.  The patient's medical history was not provided.  No relevant concomitant medications were reported.    On 29 Dec 2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot# 011J20A) by injection for prophylaxis of COVID-19 infection.     On 29 Dec 2020, patient developed minimal soreness and muscle pain in left arm at injection site. The pain and soreness increased on 30 December 2020. Patient also, developed discomfort when raising left arm over his head. No treatment information was provided.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.    The outcome of the event was unknown.; Reporter's Comments: This case concerns a 35 year-old, male patient, who experienced events of muscle pain in left arm at injection site.  The event occurred the same day after the first and last dose of mRNA-1273 vaccine administration. 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 and the events are assessed as possibly related.
mom describes infantile spasms occuring x 1 wk & describes some occuring x 3 wks; witnessed 15-20 episodes in clinic; mom also substace abuser during preg; pt adm for full neuro w/u;
12/20/2022 I had been around people who were testing positive. I was having a runny nose. I tested negative with a COVID-19 home test. On Wednesday, 12/21/2022, the runny nose turned into a headache by the end of the day I went to an outdoor event, and I was shivering, and I was having muscle aches. I came home and tested positive with a COVID-19 home test. On Thursday morning, on 12/22/2022 I did a telehealth. They went through a checklist and told me I was eligible to receive PAXLOVID. They prescribed it on 12/22/2022 and I started taking it on that day. I started feeling better the next day, but probably the 24th of December I started feeling better. In time I stated not noticing the symptoms as much. My nose was not running, and headache and muscle aches went away pretty quickly, and I did not have a fever anymore after Wednesday night, 12/21/2022. 12/28/2022, I am feeling better, but I am still testing positive as of this morning.
Muscle pain; Weakness at injection site; Limited mobility of arm/shoulder; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: ER2613 NNS Quadmed) via an unspecified route of administration in the right arm on 24Mar2021 at 10:00 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 24Mar2021 at 20:00, the patient experienced muscle pain, weakness at injection site and limited mobility of arm/shoulder. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcomes of the events muscle pain, weakness at injection site and limited mobility of arm/shoulder were not recovered at the time of reporting.  No follow-up attempts are needed. No further information is expected.
LOCAL SWELLING AND REDNESS OF LEFT ARM AT INJECTION SITE; 6x6 cm
This spontaneous report as received from an administrator via field representative refers to a 17 year old male patient. Information regarding patient's medical history, concurrent conditions, drug reactions/allergies and concomitant therapy were unknown by the reporter. On 10-JUN-2016, the patient was vaccinated with unidentified Merck HPV vaccine (GARDASIL or GARDASIL 9) lot # unspecified, via intramuscular route. The reporter stated that after receiving the vaccine, the patient passed out and suffered a concussion. The reporter did not know which shot in series was administered. The patient sought medical attention and was at the physician's office. Outcome of the events were unknown. Causality assessment was not provided. No further adverse event information was provided. Upon internal review, the event loss of consciousness was considered to be medically significant. Additional information has been requested.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site induration in a 56-year-old female patient who received SHINGRIX (batch number 32GR4, expiry date 4th July 2020) for prophylaxis. On 31st May 2018, the patient received SHINGRIX (subcutaneous). On 31st May 2018, unknown after receiving SHINGRIX, the patient experienced intramuscular formulation administered by other route. On 1st June 2018, the patient experienced injection site induration, fever, general body pain, headache, gastrointestinal symptom nos, arthritis, joint pain, injection site erythema, chills and influenza-like symptoms. On an unknown date, the outcome of the injection site induration, fever, general body pain, headache, gastrointestinal symptom nos, arthritis, joint pain, injection site erythema, chills and influenza-like symptoms were recovering/resolving and the outcome of the intramuscular formulation administered by other route was unknown. The reporter considered the injection site induration, fever, general body pain, headache, gastrointestinal symptom nos, arthritis, joint pain, injection site erythema and chills to be unrelated to SHINGRIX. It was unknown if the reporter considered the influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: One day after vaccination, the patient experienced all adverse events. On 2nd June 2018, the patient came into the pharmacy to show her the injection site. At this time, the registered pharmacist (Rph) realized that the vaccine was given subcutaneously. This led to inappropriate route of vaccination. The patient reported having every reaction listed in the package insert. Most concerning was a red circle at the injection site, and the injection site was hard as a rock, also experienced fever, chills, headache, gastrointestinal symptoms, described as flu-like symptoms and also arthritis or pain in the joints along with pain all over the body. When the reporter had spoken to the patient 2 days post vaccination, the symptoms were getting better.
could not get out of bed; chills; muscle aches; excruciating headache that lasted 12 to 15 hours; recieved 3rd dose of covid-19 vaccine.; Iappropriate schedule; This spontaneous case was reported by a health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Iappropriate schedule), EXTRA DOSE ADMINISTERED (recieved 3rd dose of covid-19 vaccine.), LETHARGY (could not get out of bed), CHILLS (chills) and MYALGIA (muscle aches) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031B21A, 003C21A and UNK) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included SARS-CoV-2 infection (Patient was positive of covid-19 on 21Jan2021.) and Pneumonia. Concomitant products included SPIRONOLACTONE and PAROXETINE HYDROCHLORIDE (PAXIL CR) for an unknown indication.   On 10-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-May-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Iappropriate schedule). On 08-May-2021, the patient experienced EXTRA DOSE ADMINISTERED (recieved 3rd dose of covid-19 vaccine.). On an unknown date, the patient experienced LETHARGY (could not get out of bed), CHILLS (chills), MYALGIA (muscle aches) and HEADACHE (excruciating headache that lasted 12 to 15 hours). On 10-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Iappropriate schedule) had resolved. On 08-May-2021, EXTRA DOSE ADMINISTERED (recieved 3rd dose of covid-19 vaccine.) had resolved. At the time of the report, LETHARGY (could not get out of bed), CHILLS (chills), MYALGIA (muscle aches) and HEADACHE (excruciating headache that lasted 12 to 15 hours) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 antibody test: 20 (High) high antibody number was 20.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient reports experiencing little bit of fever, backache, body ache, and extremely sore arm after receiving the third Moderna Covid-19 vaccine. No treatment was reported. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable, reporter didn't provide causality assessment.   This case was linked to INC.-MOD-2021-118621 (E2B Linked Report).; Sender's Comments:  INC.-MOD-2021-118621:1st Dose
4/28/17  Communication: Mom reports left leg is red and swollen w/pain from the buttock to the ankle. He had a DTaP vaccine in the left thigh on Wed 4/26/17. Mom unsure if he has a fever as she doesn't have a thermometer at home. Transferred to scheduling to set up appt for today. 4/28/17 Office visit: History of present illness: The patient presents for rash. The symptom(s) are described as moderate and worse. Affected area(s) include right thigh. Relevant history positive for family history of dermatitis.  Mom reports yesterday area around injection site was red, she spoke with nurse and was told to place ice on area which she did. Today she reports redness and swelling from tight buttock to ankle, child has been limping. Physical Exam: Skin:  Right thigh with edema from hip to knee, erythematous, warm to touch. Assessment/Plan:  Cellulitis of right thigh. Take all of antibiotic that is prescribed, can give Tylenol if child is painful. If swelling or redness continue to spread after being on antibiotic return to office or take child to the ER. 5/1/17 @ 2:14  I called mom and she said redness is gone, some tenderness, walking on leg fine.
arrived to hospital 4-5 days after receiving booster with complaints of no fetal movement at 30+6/7 weeks.  Received booster on Saturday 11/6 (unknown in chart about which brand booster) and pt developed a fever and high blood sugars over the next few days.  Baby had a non reactive tracing over 2 hours (11/11/21)  and received an emergency c/s  (11/11/2021 at 0217) with a pale baby, no blood noted in umblical cord and required intense resuscitation and blood transfusion.  Unknown etiology (no obvious abruption).
Multiple tender points with constant pain; Multiple tender points with constant pain; Abdomen pain intensity 4-5 constant, increase with movement; Frequent chest and back pain; Frequent chest and back pain; Frequent headaches (becomes migraine as well); Frequent headaches (becomes migraine as well); Unable to deep sleep; Brain fog; Numbness; Weakness; Pain in arm and legs; Fatigue; Anxiety; Unable to focus; This is a spontaneous report received from a contactable consumer or other non-healthcare professional (patient reported for himself). A 16-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EP7534), via an unspecified route of administration, administered in Arm Left on 21Mar2021 (at the age of 16-years-old) as dose 2, single for COVID-19 immunisation. Medical history included none (no). There were no concomitant medications. Patient received the most recent COVID-19 vaccine facility in other. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, ws the patient did not diagnosed with COVID-19. Since t he vaccination, patient has been tested for COVID-19. The patient did not received any other medications within 2 weeks of vaccination. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN6203 via an unspecified route of administration, administered in Arm Left on 28Feb2021 (at the age of 16-years-old) as dose 1, single for COVID-19 immunisation. The patient experienced multiple tender points with constant pain, abdomen pain intensity 4-5 constant, increase with movement, frequent chest and back pain, frequent headaches (becomes migraine as well), unable to deep sleep, brain fog, numbness, weakness, pain in arm and legs, fatigue, anxiety, unable to focus on 09Apr2021. Treatment was received for the events as complete GI evaluation omneprazole and gabapentin. Patient visited Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The patient underwent lab tests and procedures which included sars-cov-2 test: negative (Nasal Swab) on 10Apr2021, sars-cov-2 test: negative (Nasal Swab) on 03Sep2021. The outcome of the events was reported as not Recovered.  Follow-up attempts are completed. No further information is expected.
The day after vaccination I had fever chills and my Lymph node in my right armpit got swollen as big as a golf ball. It was sore, the pain was constant and went down after a week and half.  I had a phone consult with my doctor, No symptoms after the first dose of vaccine.
Information has been received from a physician concerning a 7 month old female, with no medical history and no allergies, who was vaccinated with an oral first, second, and third dose of Rotavirus on 11-AUG-2006, 15-NOV-2006, and 16-JAN-2007, respectively. Concomitant vaccines administered on 16-JAN-2007 included a dose of Prevnar, a dose of Influenza (unspecified) and a dose of Pediarix. On 05-Mar-2007 the patient experienced lethargy, abdominal pain, bloody stool, and a prolapsed rectum. The patient was hospitalised for 2 nights. The patient was given a hydrolic enema. No surgery was needed. Subsequent, the patient completely recovered. No product quality complaint was involved. Additional information has been requested.
The patient reported that he had surgery to remove part of damage colon.; Allergy; ache; Fever; This is a solicited report based on the information received by Pfizer (Mfr. Control No.: 21K-163-4082894-00). A contactable consumer reported himself. A 65-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 2 intramuscular in Apr2021 (Batch/Lot number was not reported) at age of 65-year-old as single dose for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at UNK (CF) for Moderate to severe adult Crohn's disease. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient received 1st dose Intramuscular bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) in Mar2021 at age of 65-year-old. It was unknown if he was enrolled in a COVID-19 Vaccine Trial. The patient experienced the patient reported that he had surgery to remove part of damage colon on an unspecified date, fever on Apr2021, allergy on an unspecified date, ache on Apr2021. The event colopathy was reported as serious as medically significant, other events reported as non-serious. Clinical course: The patient reported that he had surgery to remove part of damage colon. In Apr2021, he received 2nd dose COVID-19 Vaccine manufactured by Pfizer BioNTech. He had fever for one day and achy after second covid vaccine. He also had allergies. The action taken in response to the events for bnt162b2 was not applicable, for adalimumab was unknown. The outcome of the events was recovering.   Causality for HUMIRA (ADALIMUMAB): The reporter's causality for the events of DAMAGED COLON, FEVER, ALLERGIES and ACHY with HUMIRA (ADALIMUMAB) was no reasonable possibility. Causality for FIZER BIONTECH COVID-19 VACCINE: The reporter's causality for the events of Fever and Ache was Probable, for other events was not reported.  The reporter's assessment of the causal relationship of the events colopathy and allergy with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported fever, allergies, achy and the administration of the COVID19 vaccine, BNT162B2, based on the reasonable temporal association.  Conversely, the reported "surgery to remove part of damage colon" is unrelated to BNT162B2.
51 y/o female, no chronic health problems. 14 days following first COVID Pfizer vaccine, I felt unable to take a deep breath, on day 15 following the vaccine, I became short of breath,; on day 16 I was having mild chest pain with inspiration and shortness of breath;  day 17 following vaccination I became significantly short of breath, with moderate to severe chest pain with inspiration and tachycardia (heart rate in the 140's). I called my PCP who ordered an EKG, CXR, COVID swab, a metabolic panel,  a CBC, and a D-dimer. My D-dimer was elevated and he called me to go directly to the emergency department, which I did and had a CTA chest. I was diagnosed with multifocal pulmonary emboli in my right lung with a slight pleural effusion on my left lung. I had a duplex ultrasound of my legs which was negatve for DVT, and an echocardiogram which was within normal limits. I was finally diagnosed with acute unprovoked pulmonary embolism, given a Heparin bolus and started on a Heparin IV infusion. Ultimately, I transitioned to Eliquis PO and was discharged from the hospital within 24 hours.
immediately started to perspire after the shot. then had behavioral change. usually well behaved at baseline on his medications, but he started acting strangely and even tried to strangle his mother. she notes that his eyes were angry and looked like he wanted to kill her.
PT WAS SITTING FOR 15 MINUTES AFTER HIS SHOT. AROUND 10 MINUTES AFTER HE DID NOT LOOK RIGHT. I ASKED IS HE WAS OK AND HE SAID NO, HE IS NOT AND THEN PASSED OUT. HE DID HAVE A PULSE. HE WAS OUT OF IT LESS THAN 2 MINUTES. HE DID URINATE HIMSELF. AMBULANCE WAS CALLED AND HE WAS EXAMINED. HIS BP, PULSE, AND O2 RETURNED TO NORMAL. THE PATIENT REFUSED FURTHER MEDICAL EVALUATION AND REFUSED GOING TO EMERGENCY DEPARTMENT.
patient left pharmacy premises after 15 mins with no complaints. patient came back after 1 hour with hives and itchiness. benadryl liquid was given at 25mg
Developed multiple discrete pruritic, erythematous papules and pustules around hairline, on face, neck, back, and chest 17 days after Smallpox Vaccination.    Reports history of frequent folliculitis after shaving and haircuts.  No history of acne, herpes, or eczema.  Consulted with Dermatology Dept.   Final Assessment:  Likely Non-viral Pustulosis/Folliculitis No evidence of Vaccinia autoinoculation.  Tx:  Sx. treatment, No shaving, Warm Compresses