chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sever hives starting about 36 hours after dose.; Current age: 10 years, Dose recieved 1; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 10 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 17Nov2021 15:15 (Lot number: FK5127) at the age of 10 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: FLU. The following information was reported: PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (non-serious) with onset 17Nov2021 15:15, outcome "unknown", described as "Current age: 10 years, Dose recieved 1"; URTICARIA (non-serious) with onset 19Nov2021 06:00, outcome "not recovered", described as "Sever hives starting about 36 hours after dose.". The events "current age: 10 years, dose recieved 1" and "sever hives starting about 36 hours after dose." were evaluated at the physician office visit. Therapeutic measures were taken as a result of urticaria.  Additional information: Other vaccine 4 weeks product included Flu. No other medications in two weeks. Sever hives starting about 36 hours after dose. Ongoing now pt say 6. Not had covid prior vaccination. Not tested covid post vaccination. No known allergies.  Follow-Up (29Nov2021): Follow-up attempts are completed. No further information is expected.
Red; Warm; This case was reported by a consumer and described the occurrence of injection site erythema in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 5th October 2019, the patient received the 1st dose of Shingrix. On 10th October 2019, 5 days after receiving Shingrix, the patient experienced injection site erythema and injection site warmth. On an unknown date, the outcome of the injection site erythema and injection site warmth were unknown.   It was unknown if the reporter considered the injection site erythema and injection site warmth to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient stated, she got first shingles shot on Saturday, last week. On the last night before the reporting date, the patient stated it started getting red and was warm.  It was not swollen, was no longer sore or not sore to the touch.  She asked should need to checkup and treatment be sought or just consider these events as common side effects of Shingrix vaccination. To this question, GlaxoSmithKline representative told her that, because each patient's clinical situation is unique, GlaxoSmithKline has no specific recommendations on adverse reaction management. GlaxoSmithKline recommends healthcare providers use their clinical judgment. Specific management of adverse reactions was not studied in the clinical trials of Shingrix and recommend that the patient should speak with the healthcare provider regarding this question as they were able to assist the patient.
A non-serious, spontaneous report of administered expired FLUMIST was received from a other health professional concerning a 22-year-old female. Neither medical history nor concomitant medications were reported. The product expired on 12-Dec-2010. On 13-Dec-2010, the patient received expired product. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. 14-Feb-2011: Follow up call was conducted on 14-Feb-2011, no adverse events were reported following administration of the expired FLUMIST.
pt brought to ED after a fall; subarachnoid hemorrhage; c/o fatigue, cough, body aches for the past week; initially not hypoxic; positive for COVID; monoclonal antibodies and steroids given; became hypoxic and condition worsened; O2 supplementation; transferred to MICU; O2 demands increased; given baricitinib and ABX; DNR/DNI; eventually refused to wear BiPAP; transitioned to comfort care; passed away peacefully
This spontaneous report as received from a registered nurse (clinical manager/medical assistant) refers to a patient of unknown age and gender. On 14-AUG-2013 the patient was vaccinated with M-M-R II (lot #0517AA, expiration date 08-APR-2013) (dose, route and anatomical location unspecified). No adverse effect reported. The patient's outcome was unknown. Additional information has been requested.
Immediately after receiving vaccines he cried for more than four hours. After that he lost eye contact and the words he was saying and has never been the same child.
Patient tested positive for COVID after receiving first Moderna COVID-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (Patient tested positive for COVID after receiving first Moderna COVID-19 vaccine) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Patient tested positive for COVID after receiving first Moderna COVID-19 vaccine) (seriousness criterion hospitalization). The patient was treated with AMOXICILLIN on 07-May-2021 at an unspecified dose and frequency and AZITHROMYCIN on 19-May-2021 at an unspecified dose and frequency. At the time of the report, COVID-19 (Patient tested positive for COVID after receiving first Moderna COVID-19 vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication information reported. The reporter did not have any information on when or how long the patient was hospitalized.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Dizziness, Arthralgia & Fever Narrative:  Other Relevant History:
Day after vaccination I experienced expected very mild side effects (low fever, fatigue, congestion, etc.). The symptoms didn't last the entire day and I was feeling better that evening. About 48 hours after I received vaccination I began developing rash just below the hairline on the back of my neck. The rash stayed local to where it developed. Started out as red raised bumps. It was warm to the touch, itchy, and burning. The 3 day the rash became fluid filled blisters. Itching and burning resolved the 30th of September, the rash is still present but smaller and looking better.
Got chickenpox on 6/20/01 and had vaccine on 11/3/99.
Patient felt sweaty and dizzy after 15 minutes post op and care back in. We took BP, gave water. No pain except where injection was giving, no problem breathing normal. Didn't take BP mediation this morning. Took medication now in post op. BP 183/117  2nd) 166/91, 66 pulse  3rd) 153/89, pulse 61, 99%, 63. 4 th)  153/92,   98.2 temp.
URI symptoms for 3 days starting on 9/24/21 along with diarrhea
Left leg swells after receiving shot in left arm; right leg is also swelling since receiving shot in right arm; This is a spontaneous report from a contactable consumer, the patient. An 83-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 04Feb2021 at 16:15 (at the age of 83-years-old) and received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 25Feb2021 (at the age of 83-years-old); both as a single dose for COVID-19 immunisation. Medical history included diabetes, high blood pressure, high cholesterol, dry eyes, arthritis, mild stroke and known allergy to penicillin. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient previously took naproxen (MANUFACTURER UNKNOWN), fosinopril sodium (MONOPRIL), verapamil (reported as CALAN), benzocaine (MANUFACTURER UNKNOWN) and beni are (as reported); all for unspecified indication from unknown date and experienced drug allergy. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 04Feb2021, patient's left leg got swollen after receiving shot in left arm. On 25Feb2021, patient's right leg got swollen after receiving shot in right arm. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event left leg swells after receiving shot in left arm was not recovered at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
projectile vomiting; Incontinence; Soreness and joint / muscle pain; Soreness and joint / muscle pain; nausea; Fever (peaking at 101.3 so far); This is a spontaneous report from a contactable consumer (patient) in response to Non-HCP letter sent in cross reference case which included that a 41-year-old female patient received second dose bnt162b2 (Formulation: Solution for injection; Lot Number: EN6198) via an unspecified route of administration on 17Feb2021 (at the age of 41 years old) as dose 2, single for covid-19 immunisation. The patient medical history was not reported. Patient historical vaccine includes first dose bnt162b2 (lot number: EL3247) on 27Jan2021 for Covid-19 immunisation and experienced soreness and joint/muscle pain, nausea, fever on 27Jan2021; elevated heart rate (peeking at 145) on 28Jan2021 and Incontinence on 29Jan2021. Concomitant medications included influenza vaccine (FLU VACCINE VII) taken for an unspecified indication from 25Jan2021 and ongoing; cannabis taken for an unspecified indication from May2019 and ongoing; dimenhydrinate taken for an unspecified indication at 50 mg from 28Jan2021 to 26Feb2021 and naproxen sodium at 220 mg taken for an unspecified indication from 28Jan2021 to 26Feb2021. The patient experienced soreness and joint / muscle pain, nausea, fever (peaking at 101.3 so far), projectile vomiting, incontinence on 17Feb2021. Patient did not have admission to hospital due to the event. Therapeutic measures were not taken as a result of the events. The outcome of the events soreness and joint/muscle pain, Fever (peaking at 101.3 so far), projectile vomiting was recovered on an unknown date in 2021; nausea, incontinence was not recovered. No follow-up attempts are needed. No lot/batch number requested. No further information is expected.
Monday I woke up with a bad headache and that lasted for 2 and a half days. I had body aches all over especially in the joints. I also had sinus drainage. I had a fever as well and that lasted into Tuesday. I went into the clinic Monday morning after taking 2 at home COVID-19 tests. I immediately went to the urgent care and I was sick for about 2 and a half days. They confirmed it was COVID-19 at urgent care as well. I was prescribed LAGEVRIO (molnupiravir) 200 mg and I took 4 of them twice daily for 5 days. Shortly after I took my first dosage, within 4-6 hours I felt like I was improving. I started getting better from there. My best guess of where I got it could have been from my local gym.
This case was reported by a nurse via call center representative and described the occurrence of pain in a 28-year-old female patient who received FLUARIX QUADRIVALENT (batch number K4GP4, expiry date 24th June 2018). On 14th September 2017, the patient received FLUARIX QUADRIVALENT (intramuscular) .5 ml. On 14th September 2017, immediately after receiving FLUARIX QUADRIVALENT, the patient experienced pain. The patient was treated with medication unknown, Ice Pack and NSAID's. On an unknown date, the outcome of the pain was unknown. The reporter considered the pain to be probably related to FLUARIX QUADRIVALENT. Additional details were reported as follows: The patient's physician was concerned that the vaccine was administered too high on her left deltoid and was not injected into the muscle. The patient experienced sharp pain which progressively got worse on 18th September 2017. She had to seek medical attention. The patient was told if the pain does not get better, then to follow up with her physician who would refer her to an orthopedic doctor. The patient was an avid swimmer and was unable to perform a single stroke. The sales rep stated the facility was going to report the adverse event to Vaers.
Covid arm: itchy, hard, red raised 2-3 inch diameter circle at injection site.
Fever 7/6/2010 at night at 10:00 pm. Redness 38mm x 45mm - PCV-LD 50mm x 44mm-MMR-RD.
This spontaneous report was received from a healthcare worker who refers to a 18 years old female patient (who was not in pregnant) with hypothyroid and no drug allergies/reactions. On 03-OCT-2012, the patient was vaccinated intramuscularly with a first dose of GARDASIL lot # (672233/1561AA, expiry date 26-AUG-2012) (dose and anatomical location not reported). Concomitant medications included: ARMOUR THYROID TABLETS. On 03-OCT-2012, a few minutes after vaccination the patient fainted, after she stood up in the exam room. It was reported that the patient hit her head "very hard" on the floor and E.M.S. was called to transport the patient to the emergency room for unspecified treatment. The patient was "not very responsive" and fainted a second time after "smelling salts" were used after she fainted the first time. The patient did not receive any treatment for adverse events. No lab diagnostic tests were performed. At the time of the report patient's status was reported as not recovered. Additional information has been requested.
Erythema 15 cm x 17 cm over the dorsal aspect of left arm, extending from injection site. Increased warmth, mild tenderness. No abscess.
Fatigue, arm soreness, and chills began about 9pm the day of the vaccine. The next day I had body aches and lethargy and more chills until about 3pm. I didn?t take any medication- I just slept it off.
sore arm after first dose; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PAIN IN EXTREMITY (sore arm after first dose) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination.     Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm after first dose). At the time of the report, PAIN IN EXTREMITY (sore arm after first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications were reported.   This case was linked to MOD-2021-281266, MOD-2021-128083 (Patient Link).
Had an allergic reaction with Prevnar 13; The back of his legs started aching/his whole middle extremities were doing the same thing/it went down his arms and came back up; This is a spontaneous report from a contactable consumer. A 72-years-old male patient received second dose of pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) (PREVNAR 13, Solution for injection in pre-filled syringe, lot number and expiry date not reported), via an unspecified route of administration on 20Oct2020 at a single dose for immunization. The patient's medical history was not reported. There were no concomitant medications. Patient previously had the Pneumonia shot as immunization on an unknown date (first dose) (tradename unspecified, reported as Pfizer pneumonia vaccine). On 20Oct2020, patient had an allergic reaction with pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) and was asking if he was safe to have the COVID 19 vaccine and will not have any allergic reaction as he had with pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein). Patient was asking for the ingredients of the vaccine. Received call from patient regarding the Pfizer COVID vaccine and Pneumonia shot. He had the second pneumonia shot Pfizer product on 20Oct2020, and never had a reaction before to a shot in his life. He left the doctor's office and walked outside. The back of his legs started aching (20Oct2020). By the time he got in the car, his whole middle extremities were doing the same thing. So, he parked his car and went back inside, then it went down his arms and came back up. It was pretty quick. They took his blood pressure and it was fine. He had no temperature, no rash, no nausea, no palpitations or anything like that. He just hurt like nothing he had before. It hurt more to sit down than stand up. They kept him an hour and he walked around and was fine. He went home and was fine. He did not have anything more happen. He was 72 years old and in good health. He doesn't take medications. He was reading that you should not get the Pfizer shot if you had an allergic reaction to a dose of the COVID or any ingredient in this vaccine. He talked to his doctor yesterday or again today (14Jan2021) and he suggested he call Pfizer to see what his options are and if should he get it. He did not wish to complete report and requested he be transferred to have his question answered. No further details provided. The outcome of the events allergic reaction and "the back of his legs started aching/his whole middle extremities were doing the same thing/it went down his arms and came back up" was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report as received from a nurse refers to a unspecified number of patients of unknown age and gender. Medical history and concurrent conditions were not reported. On 12-JUL-2016, the patients were orally vaccinated with improperly stored doses of the ROTATEQ (dose, frequency and indication were not reported, lot # L033543 with expiration date 30-MAY-2017; L048854 with expiration date 31-AUG-2017). Concomitant therapy was not reported. No adverse effects was reported. Administered vaccines experienced the temperature excursion of 1.9C for 30 minutes, for a cumulative time out of range of 2 hours, 30 minutes on 12-JUL-2016. Data logger was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Itching, hives over arms and chest about 30 min. after receiving the H1N1 FluMist intranasal vaccine. Symptoms resolved with 2 Claritin.
flu-like symptoms - no fever, muscle and joint aches, headache, flare up of psoriasis, fatigue
One diagnoses was acne and the other scabies; One diagnoses was acne and the other scabies; feel raised spots; very sensitive to the touch/She also can't wear anything but natural fibers.; It has bothered her on and off; rash around her waist and on her nose; chills that day and it got progressively worse.; This case was reported by a consumer via call center representative and described the occurrence of acne in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of no adverse event (received 1st dose on 5th March 2019).   On 13th August 2019, the patient received the 2nd dose of Shingrix (intramuscular) 5 ml. On 13th August 2019, less than a day after receiving Shingrix, the patient experienced chills. In October 2019, the patient experienced rash. On an unknown date, the patient experienced acne, scabies, raised rash, touch sensitivity increased and feeling abnormal. On an unknown date, the outcome of the acne, scabies, raised rash, touch sensitivity increased and feeling abnormal were unknown and the outcome of the chills was recovering/resolving and the outcome of the rash was not recovered/not resolved.   It was unknown if the reporter considered the acne, scabies, chills, rash, raised rash, touch sensitivity increased and feeling abnormal to be related to Shingrix.  Additional details were reported as follows: The patient received Shingrix started to get chills that day and it got progressively worse.  On an unknown date between 1 and 3 months the patient experinced acne, scabies, rash, raised rash, touch sensitivity increased and feeling abnormal.  This lasted a couple of days but got better.  Then in October, she got a rash around her waist and on her nose. It had bothered her on and off since.  She compares it to the feeling of having a sunburn and raised spots and was very sensitive to the touch.  She also cannot wear anything but natural fibers.  She also had chills during this time but not as bad as when she first got the 2nd dose.  There was no fever associated with the chills. She had been to several doctors who said it was not related to the vaccine.  On an unknown date the patient was diagnosed with acne and scabies. Reporter did not consent to follow-up.
At the 15 min mark patient stated that she was going to sit out in the waiting room just a few minutes longer, patient had experienced some chest tightness.  Patient said she wasn't sure if it was from the mask or from the short. Had patient lower mask take some deep slow relaxing breaths, she said it helped a little but was still having the chest tightness.  Patient was offered a Benadryl and patient took this. 20 mins later patient was feeling more relaxed and was ready to leave.
Patient telephoned the 1-866 number and requested a call back. She called on 11-25-08 and I called her that day.  She stated that since she had the flu vaccination she has had arm pain.  At first she said she thought it would go away and did not call us.  Yesterday, 11-25-08 was the first day she called to notify us.  She states she has gone to an orthopedic surgeon for an evaluation of the pain.  She states the physician found no broken bones and prescribed some Diclofenac for the pain.  She states that she has the pain and wants to know what to do.  She called our clinic to see what she should now do.
Arm swollen, tight, warm. Mom notice 03/12/2005. States child not complaining about it. States better today.
Client had waited in clinic 15 to 20 minutes after vaccine and had walked to her daughters car and got in.  Her daughter came back in the clinic saying something was wrong with her mother.  Client was found sitting on front seat unresponsive.  Nurse reports no B/P no pulse.  Client was pulled from the car by several nurses and laid to the ground.  She was incontinent of urine, aroused after Nurse did Sternal Rub.  EMS activated at approx. 2:04 PM.  2:06 PM B/P 210/140 pulse 72 thready. , 2:08 PM  B/P  190/112 P 72 .   Blood sugar was 180 when EMS arrived.  Client transported to Medical Center via ambulance at approximately 2:15 PM.