chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a registered nurse (R.N.) and refers to unspecified adult female patient of unknown age. No medical history and concurrent conditions of the patient were reported. On 23-MAY-2012, the patient was vaccinated with first dose of MMR II injection and on 16-JUL-2012, with second dose of MMR II injection (lot number, dose, site and route of administration was not reported). No concomitant medications were reported. The patient had titers drawn on 20-MAY-2013. The titer result for measles was equivocal. The actual titer result was 15.4 for measles. No adverse events were reported. The outcome of hepatitis b surface antibody negative and inappropriate schedule of drug administration was unknown. The causality of hepatitis b surface antibody negative was not reported. No product quality complaint (PQC) was filed. No additional information provided. Additional information has been requested.
noted by mom & staff pale, gray appearance & briefly shaking one leg; remained pale & lethargic for 3-4 hr; t36.6-37.8 BP 110/50; myoclonic spasm observed;
Headache, Myalgia, NauseaVomiting, chills, fatigue, site pain; chest pain Narrative:  First vaccination: a. Arm pain at injection site b. Nausea Second vaccination: a. Arm pain at injection site b. Headache c. Muscle and body aches (particularly one-sided on the side I received the injection) d. Chills e. Fatigue f. Chest pain
Red rash on arm; Itching; This spontaneous case was reported by a nurse and describes the occurrence of RASH ERYTHEMATOUS (Red rash on arm) and PRURITUS (Itching) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (allergic patient with drugs).    On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, the patient experienced RASH ERYTHEMATOUS (Red rash on arm) and PRURITUS (Itching). The patient was treated with HYDROCORTISONE at an unspecified dose and frequency. At the time of the report, RASH ERYTHEMATOUS (Red rash on arm) and PRURITUS (Itching) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.
Administered with 008C21A on 5/21, date updated to 5/20 in system. Vaccine was administered on 5/20/21 but logged after 12:00am on 5/21/2021.
Systemic: syncope-Medium, Systemic: Nausea-Mild, Systemic: Shakiness-Mild, Additional Details: Patient sat down for more than 15mins after receiving vaccine then walk out side to wait for pick up. While waiting, she got syncope and fell down on the side walk, got a bump on the leftside of her forehead. Pt complained of nausea. She felt better after given some water. She refused to call 911. Patient came back inside and continue waiting for 45 mins when her pick up arrived, she stated feeling better and wanting to leave to go back to her hotel
vasovagal reaction, patient passed out for less than 60 seconds. grayish skin, tired. Pt was feeling ok in about 20 minutes.  no treatment
Bloody stools/diarrhea 24 hours after receiving ROTATEQ. 2nd dose given with no ill effects after first dose. No treatment advised.
After receiving the vaccine on 1/22/21, within 10 minutes participant notice tightness around the base of her neck. This is her 2nd dose of the vaccine and she also notice this with the first dose. She felt tired and fell asleep at 6pm (normal time is 10pm-11pm). During the night she felt chills. She woke up at 8am with a body aches and fever of 103 F. She took 1 dose of ibuprofen 800mg tablet and alternate with Tylenol 650mg every 4 hours throughout the day. The fever went down to 99F. 1/23/21-1/24/21: Participant starting having severe diarrhea with low grade fever and headache. The evening of 1/24/21 she developed a cough and sore throat. 1/25/21: No fever. She still had diarrhea, headache and worsening cough. 1/26/21: Participant called out of work. She lost her voice and still suffering from headache, and cough. Diarrhea was improving. No fever. 1/27/21: Participant went to urgent care with cough, headache, sore throat, lost voice and seasonal allergies. 1/28/21- Symptoms improving. 1/29/21- All symptoms completely resolved.
Had flu shot in left arm - 2 days ago   First night ,a little red around the area of the injection Then got more and more red on the left arm over the last 48 hours- and now sticking out more and hot and painful to touch.  11/3/23 seen in office and prescribed: cephalexin PO SUSP 250 mg/5 mL; Give 10 mL by mouth 2 times daily for 7 days.
Received vaccine 8/30/06. Next day started with swelling, soreness, and redness that increased in size. Seen in office 9/5/06 swelling, erythema with some bruising at injection site of upper arm (Left).
Pityriasis Rosea Started with red spots on stomach, then spread to legs on both sides, back, arms.  Went to dermatologist after a week and a half. No itching.  As of 10/11 the 2 on my arms have recovered, the original and others that had popped up are stilll there  Using Triamcinolone 0.1% Cream 80Gm
This spontaneous report has been received from a physician's office nurse via company representative referring to a male patient of unknown age. Information regarding medical history, drug reactions, allergies, concomitant therapies and concurrent conditions was unknown by the reporter. On an unknown date, reported as "a few years ago," the patient was vaccinated with VARIVAX, (route of administration, dose, frequency, strength, lot#, and expiration date were unknown by the reporter) for routine vaccination. On the same date, the patient developed a black and blue reaction at the injection site and, after 2-3 days the patient developed red rash on the arm that he was vaccinated. It was unknown by the reporter if the patient sought medical attention, if laboratory diagnostic studies were performed or if treatment was given for the adverse events. At the time of reporting the outcome of black and blue reaction at the injection site and red rash on the arm was reported as recovered on an unknown date. The relatedness between the events and VARIVAX was not reported. Additional information has been requested.
Broke out in hives on my right arm and have a small patch on my stomach; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6201), via an unspecified route of administration in the right arm on 18Mar2021 at 09:45 (at the age of 39-years-old), as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within 4 weeks prior to the vaccination. Since the vaccination, the patient had not been tested for COVID-19. On 21Mar2021 at 17:30, the patient broke out in hives on right arm and had a small patch on stomach. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of adverse event and included treatment with BENADRYL. The clinical outcome of the event hives was resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Itching, red rash size of deck of cards on shot injection site. Started out the size of the bandage, then noticed 4 days later the size.
The next afternoon I started having from knees into feet the feeling of sore bones (best described similar to sore muscles) which lasted several days. This was followed by nervous system firing at will from head to toes ever since. Within days of injection also nervous system firing / burning in previous injection/blood drawn sites in both arms and hands over the many years. Taste and smell effected as well. Ever since nervous system has a mind of it's own firing and stimulating issues at will.   Over last 3 months been dealing with various gut-kidney-back-afib issues that seem to be related. My taste and smell changes day by day as well. These issues keep changibg-evolving by the day.
fibromyalgia; post-herpetic neuralgia; herpes zoster; Information has been received from a lawyer regarding a case in litigation and refers to a currently approximately 75-year-old female patient (pt). No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 22-FEB-2014, the pt was vaccinated at her local pharmacy with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot #, and expiration date were not reported) for the long-term prevention of shingles and zoster-related conditions. Subsequently, on unknown dates, the pt was treated by healthcare providers for the following injuries resulting from zoster vaccine live (ZOSTAVAX) use: herpes zoster, post-herpetic neuralgia and fibromyalgia. The outcome of the events was not reported.  The reporter considered the events of herpes zoster, post herpetic neuralgia and fibromyalgia to be related to zoster vaccine live (ZOSTAVAX).
Patient presented to the ED and was subsequently hospitalized with severe sepsis within 6 weeks of receiving covid vaccination.
Left swelling, pain, and tenderness Neck glands swollen and painful Extreme fatigue for 48 hours
Patient contracted COVID  during an outbreak.  Patient went to the ED on 2/28  and was sent home.  Patient returned to the ED on 1/2 and was admitted.  Patient expired on 1/3
Initially, I had pain at the injection site which I expected.; But, since for the past couple of days I I have had heart palpitations off and on; My chest feels tight.; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via an unspecified route of administration in the left arm on 10Apr2021 at 11:15 (at the age of 51-year-old) as a single dose for COVID-19 immunisation. Medical history included obesity. Concomitant medications included ibuprofen (MANUFACTURER UNKNOWN), multivitamin and probiotic, all used for unknown indication from unspecified dates and unknown if ongoing. The patient had no known allergies. 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 10Apr2021 at 20:00, the patient experienced pain at the injection site which she expected. Since past couple of days, she had heart palpitations off and on and her chest felt tight. Therapeutic measures were not taken as a result of these events. These events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events injection site pain,  heart palpitations  and  chest tightness was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Pt exp erythema & inflammation @ inject site p/recvd Td vax;
A golf ball sized induration developed two days post Zostavax vaccine in the general area the vaccine was administered on the left arm. The induration was warm, hard, and had surrounding erythema twice the size. There was a concern of cellulitis, so a 7 day course of cephalexin 500mg four times daily was started. The redness, warmth, and size of the induration was significantly reduced within one day of treatment with cephalexin. It resolved within two to three days of antibiotic treatment.
Janssen COVID-19 Vaccine EUA Two hours after vaccination, developed itchy rash at injection site, down right arm and chest that was alleviated by topical Benadryl cream. NO trouble breathing. NO swelling of throat. 8pm developed nausea and vomiting. Fever and Chills. Joint pain. Numbness and tingling of hands and feet. Extreme dizziness. Fever, Chills, Fatigue, Muscle pain, right lowback pain lasted through 3/30/21. Morning of 3/31/21 Broke fever. Still currently have body aches and dizzienss. No fever.
Employee began experiencing pain and decreased ROM in shoulder hours after injection. She was evaluated by ortho, and IR was determined that injection was placed too high and went into her bursa.
The spontaneous prospective pregnancy report as received from a nurse refers to a 31 year old female patient. The patients medical history was none. On 03-APR-2014 the patient was vaccinated with first dose of VARIVAX (Lot# J007953, expiry date: 27-JUN-2015)(Dose/Frequency: 0.5 milliliter (ML), Route: Subcutaneous (SQ)). Concomitant medications were none. On 01-MAY-2014 the patient was vaccinated with second dose of VARIVAX (Lot# J012375, expiry date: 03-OCT-2015) (Dose/Frequency: 0.5 milliliter (ML), Route: Subcutaneous(SQ)). The patient became pregnant with LMP of 03-MAY-2014 and EDD of 07-FEB-2015. The outcome of received 2 doses of VARIVAX and found out she was pregnant was unknown. Additional information has been requested.
04/12 - Palpitations early morning and couple of times during day 04/13 - Palpitations early morning and bed time 04/14 - Palpitations on and off - severe early morning and bed time 04/15 - Mild to moderate headache (mostly left side) throughout the day, palpitations early morning and few long lasting during the day and bed time 04/16 - Continued mild headache, early morning and night time palpitations. Went to see Dr. Did bloodiest and EKG (normal) 04/17 - Continued mild headache. Dr. called with abnormal D-dimer (875).  Prescribed Eliquis 2.5mg and ordered Ultrasound and CT scans of head and chest 04/19 - Continued mild headache. Did Ultrasound (lower extremities), CT scans of head and chest 04/21 - Mild headache most of the day. Received rest of blood tests -  (normal Plates, PT, INR, Fibrinogen).  CT scans of head and chest results show no signs PE or thrombosis  04/22 - Very light head during day. Mild headache evening.  04/23 - Mild headache (Tylenol provided temp relief but not completely) - Ultrasound is clear - no DVT
Undiagnosed partial seizure 1 week after 1st round of travel vaccines. Partial seizure and extended grand mal seizure 1 week after last round of travel vaccines. Continued partial and grand mal seizures ongoing problem.
Left site.  Returned due to SOB and tongue numbness;  Admin Benadryl.  VS Stable.  Recovered and dismissed @ 1637
August 10th the patient was administered  a 3rd dose of the hepatitis vaccine; This non-serious case was reported by a consumer via call center representative and described the occurrence of inappropriate age at vaccine administration in a 2-month-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number A32BB, expiry date 10-AUG-2025) for prophylaxis.   Concomitant products included HEPATITIS VACCINE, NOS (HEPATITIS VACCINE). Family history included hepatitis b carrier.   On 10-AUG-2023, the patient received the 3rd dose of Pediarix. On 10-AUG-2023, an unknown time after receiving Pediarix, the patient experienced inappropriate age at vaccine administration (Verbatim: August 10th the patient was administered  a 3rd dose of the hepatitis vaccine).  The outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 14-AUG-2023 The reporter was the parent (father) of a 2-month infant. Parent reported, that the mother of the child was a Hepatitis B carrier. Infant was given the 1st dose of the Hepatitis vaccine at birth and Parent reports that on August 10th the patient was administered a 3rd dose of the hepatitis vaccine (Pediarix), which led to Inappropriate age at vaccine administration.  Parent did not consent to follow up with HCP.
Pt complaining of pain which has persisted since 11/5/03.  Pain awakens him at night.  Denies swelling,redness, or changes in appearance at injection site.  Rates pain (on scale of 1-10,1 being slight, 10 being intolerable) as a 4 when arm is at rest and an 8 with movement.  Encouraged patient to schedule appt. to be eval by MD asap.  Has not seen a physician at this time.
Pain aggravated; Difficulty in standing; Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain aggravated), DYSSTASIA (Difficulty in standing) and DIARRHOEA (Diarrhea) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    No Medical History information was reported.   On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (unknown route) 1 dosage form. In 2021, the patient experienced DIARRHOEA (Diarrhea). On an unknown date, the patient experienced PAIN (Pain aggravated) and DYSSTASIA (Difficulty in standing). At the time of the report, PAIN (Pain aggravated) and DYSSTASIA (Difficulty in standing) had resolved and DIARRHOEA (Diarrhea) outcome was unknown.            No concomitant medications were reported.  No treatment medications were reported.  The reporter assessed event of diarrhea as related to Moderna vaccine and did not provide any causality assessment for the rest of the events with Moderna vaccine.  The reporter did not provide any causality assessment for the event of difficulty in standing with Humira. The reporter assessed the event of pain aggravated as reasonably possible with Humira and event of diarrhea as not reasonably possible with Humira.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Developed fever, rigors, H/A, and visual disturbances the day after injection. Admitted overnight for observation.
By 14:30 on April 21 I started to get body aches, nausea, a headache, and felt off. At 07:00 April 22 I woke up with severe body pain, a headache and a temperature of 102*. I utilized Tylenol to bring the fever down to 100* by 10:00. It rose again at 14:00 and 18:00 to 102* requiring more Tylenol. The fever broke around 02:00 on April 23. Body aches continue but not as severe. My injection side was sore April 21 and by 20:00 on April 22 it was very painful and became a large lump about the size of a golf ball. By 07:00 April 23, the injection site was still very swollen and painful but now is warm to the touch, and bright red.
Acute respiratory failure with hypoxia.  Patient admitted to hospital 7/21/21, CT suspicious for chronic or subacute segmental thrombus within the right upper lobe. She was discharged 7/24 but went to the ED the same day, was readmitted and then discharged again 7/27/2021.
Ineligible for second dose because he is 17 years old; A spontaneous report  was received from a consumer concerning a  male patient who received Moderna's COVID-19 vaccine (mRNA-1273) at inappropriate age.  The patient's medical history was not provided. Concomitant medication history was not provided.  On 11 Jan 2021, prior to the onset of the events, the patient received their first of two doses of mRNA-1273 (lot number: 027L20A) intramuscularly for prophylaxis of COVID-19 infection.  The consumer stated that her son received his first dose and was denied his second dose due to his age being under 18 years old. She requested to have her son be enrolled in a clinical trial in order to get his second dose.    Treatments of these events were not provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the event, inappropriate age is 17 years old was recovered on 11 Jan 2021.; Reporter's Comments: This report refers to a case of Incorrect dose administered for mRNA-1273 (lot number: 027L20A) .
This spontaneous report was received from a nurse refers to a patient of unknown age and gender. No pertinent medical history was reported. On 24-NOV-2014, the patient received an improperly stored fourth dose of RECOMBIVAX HB (lot# H010380 and expiration date was 18-NOV-2014). The RECOMBIVAX HB in question did not have any previous temperature excursions. RECOMBIVAX HB was supported with post-expiry data. Reporter stated the patient received a fourth dose of RECOMBIVAX HB because the second and third dose were given too close together. Reporter mentioned the patient also received RECOMBIVAX HB on 17-FEB-2014, 17-MAR-2014, 23-APR-2014. No adverse symptoms reported. Additional information has been requested.
Painful red and swollen arms.  Still have arm pain.  Muscle and joint pain, legs, shoulders, knees, neck lower back and hips.  All over body aches.  Brain fog, memory coughing, fatigue, insomnia, siren sound in ears,
VACCINE ADMINISTERED AFTER THE 31 DAY BEYOND USE DATE BUT BEFORE THE 45 DAY EXCURSION DATE.
On 9/8/00, the pt received her second dose of hepatitis A vaccine. Ten minutes post vax, she experienced a metallic taste in her mouth which overwhelmed her. As of 9/22/00, the outcome of the event is resolved.
Asthenia date of vaccine, within hours, then left foot swollen and tender next 2-3 days and purple half of foot, per pt report. Photo today: dependent purple ecchymosis flexor foot above MTPs, X-ray pending denies trauma not limping.
3-4 days p/inject developed fever, vomiting, bowel disorder (intrasusception) MD determined rxn not related to vax;
Since the booster shot, the ringing in his ears went away; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 82 year-old male patient received bnt162b2 (BNT162B2), administration date 18Oct2021 (Batch/Lot number: unknown) at the age of 82 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications. Vaccination history included: Bnt162b2 (First dose: 19Mar2021 with lot number ER8727.), administration date: 19Mar2021, when the patient was 82 years old, for COVID-19 Immunization; Bnt162b2 (Second dose 09Apr2021 with lot number ER8729.), administration date: 09Apr2021, when the patient was 82 years old, for COVID-19 Immunization. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious) with onset Oct2021, outcome "unknown", described as "Since the booster shot, the ringing in his ears went away". Additional information: The ringing stopped the next morning when patient woke up. Patient was on a blood pressure medicine, but dose not remember the name of it. Patient twin brother had multiple sclerosis.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report was received from a pharmacist via a company representative concerning a female patient of unknown age who on an unknown date was vaccinated with a dose of ZOSTAVAX (route, lot number and expiration date were not provided). No other co-suspects were reported. No concomitant medications were reported. It was reported that the patient experienced redness in the arm at the injection site and also had headache that occurred on a daily basis. No laboratory tests were performed. The patient sought medical attention; however, she did not receive any treatment for the event. The outcome of redness in the arm at the injection site and headache was unknown. The relatedness for redness in the arm at the injection site and headache was unknown for ZOSTAVAX. Additional information has been requested.