chrisvoncsefalvay/vaers-outcomes huggingface dataset:
feeling miserable; did not take the second dose; feeling unwell; Vaccine attacked the ankles; Vaccine attacked immune system; Throat was falling short; Anaphylactic shock; Vaccine attack on ankle; This spontaneous case was reported by a consumer and describes the occurrence of ANAPHYLACTIC SHOCK (Anaphylactic shock) and IMMUNOSUPPRESSION (Vaccine attacked immune system) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) 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 CALCIUM and FEXOFENADINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDE (ALLEGRA D) for an unknown indication.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced ANAPHYLACTIC SHOCK (Anaphylactic shock) (seriousness criterion medically significant) and DYSPHAGIA (Throat was falling short). 14-Jan-2021, the patient experienced JOINT INSTABILITY (Vaccine attack on ankle). On an unknown date, the patient experienced IMMUNOSUPPRESSION (Vaccine attacked immune system) (seriousness criterion medically significant), FEELING ABNORMAL (feeling miserable), PRODUCT DOSE OMISSION ISSUE (did not take the second dose), MALAISE (feeling unwell) and ARTHRALGIA (Vaccine attacked the ankles). At the time of the report, ANAPHYLACTIC SHOCK (Anaphylactic shock), IMMUNOSUPPRESSION (Vaccine attacked immune system), DYSPHAGIA (Throat was falling short), FEELING ABNORMAL (feeling miserable), MALAISE (feeling unwell), ARTHRALGIA (Vaccine attacked the ankles) and JOINT INSTABILITY (Vaccine attack on ankle) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (did not take the second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       15 minutes after vaccination patient had anaphylactic shock with allergies and chronic hives. The patient was taken to emergency room for 6 hours. The patient was treated with unspecified intravenous medication.  Company comment: 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.
Began experiencing spasms in right deltoid muscle am after receiving PPV. Later in the evening she experienced shoulder pain radiating to neck and increase scapular area of back. She describes pain as a burning, searing. Has right arm paresis- unable to lift above waist level. Had cortisone injection into shoulder joint 11/4 and 11/09. Took Medrol dose pack x 7 days. Having pt treatments. 3 x 1 wk (2 x to date)
Information has been received from a physician concerning a female who on 29-MAY-2007 was vaccinated with Gardasil.  On 20-JUN-2007, lab work was done as part of a regular check-up, and transient elevated liver enzymes was noted.  It was reported that the rest of the lab work was normal, and there was no elevation in bilirubin.  The patient was re-tested 3 weeks later, and all results were normal.  The patient was reported to be fine.  Additional information has been requested.  This is one of two reports from the same source.
Initial solicited report received from an investigator in the trial on 08 March 2017 and follow-up information received on 13 March 2017. A 20-year-old male subject with no significant medical history. The subject's concomitant medication was not reported. The subject received a dose of ACAM2000, lot number and route, site of administration not reported) on 02 August 2016. On 24 August 2016, 22 days after vaccination the subject was diagnosed with I30 acute pericarditis. The lab test for Troponin I was not performed, ECG done on 24 August 2016 was normal; Echocardiogram, MRI (heart, brain and spinal cord) and Lumbar puncture (spinal tap) were not performed. Treatments were not reported. The subject's outcome was not reported. Relationship to investigational product according to company: associated Additional information will be requested from the investigator. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. List of documents held by sender: none.; Sender's Comments: This case involves a healthy 20-year-old male who developed acute pericarditis with favorable temporal association post vaccination with ACAM2000. Pericarditis is a listed adverse event that may occur following vaccination with live vaccinia virus smallpox vaccines. Alternative etiologies could be Myocardial infarction, pulmonary embolism, Pneumonia, Costochondritis and pneumothorax. History of allergies or trauma was not reported. In the absence of additional information on confirmation of diagnosis with CK-MB assays, biopsy, role of study vaccine can not be ruled out.
Fever; This is a spontaneous report was received from a contactable consumer or other non hcp via a Pfizer sponsored program COVAX US support. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date were not reported) via an unspecified route of administration on 20 Apr 2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications was not reported. The patient called in and stated that she got the 1st dose yesterday 20Apr2021 and stated that she had a fever today on 21Apr2021, she asked what recommendations we had. The outcome of fever was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Breakthrough COVID-19 case with symptom onset 8/10/2021:  Fever >100.4,  Subjective fever (felt feverish), Chills,  Muscle or body aches, New loss of taste or smell,  Runny nose/Congestion,  Cough (new onset or worsening of chronic cough),  Shortness of breath or difficulty breathing,  Chest pain,  Fatigue or tiredness,  Headache,  Diarrhea (>/=3 loose/looser stools in 24 hr period). Hospitalized for 10 days. Interview on 9/5/2021: The patient was hospitalized for 10d with Covid related pneumonia. States that she has been fever free for a few days and was d/c on oxygen. She is currently followed by a pulmonologist. States symptoms are improving but still has loss of taste & smell.
Severe pain in left arm and shoulder, loss of use of arm, could not sleep for two days. Severe pain last 3 days. Residual effects of shoulder pain still present 3 months later.
Systemic: Patient reported no  reactions-Mild, Additional Details:  The patient was contacted and reported no  reactions
Child had high fever on 12/25/06.  He was treated with Ceftriaxone and Amoxicillin. He recovered quickly without complications.  Doing fine now
4:30 pm Dull headache. 02/11/2017: AM Sore arm at injection site. PM: Progressively worsening elbow and shoulder stiffness/soreness with continued headache. 02/12/2017: PM onset of neck stiffness with continued left arm soreness/stiffness and dull headache. 02/13/2015: 11 am On set of stiff left wrist. Difficulty with typing with left hand. Worsening left arm stiffness/soreness and shooting pain down left arm. PM onset of pins and needles sensation in left hand and fingers. 02/14/15: Continued headache, left arm stiffness/soreness and tingling sensation down left arm, hand and finger tips. Neck pain worse when looking down.
10/22/12 Rec'd p/c from pt stating after vaccination developed rash on (L) arm at site of injection. Itching, headache, afebrile, diaphoretic. Per RN 10/23/12 e-mail "had reaction to Flu shot".
Patient received both vaccines and then remained seated in the chair administered by my technician. However, patient was mumbling about how he did not feel so good as he began slouching off of the chair and fell to the floor. I ran out to lay back flat on his back and administer per our Emergency protocol yet patient had recovered in that time and had also urinated on himself.  He seemed to be on illicit medications based on his unusual behavior and he had not eaten or drank anything this morning.  Patient was given some water and orange juice. EMS was promptly called and they were on site to check his blood pressure, pulse, etc and patient was fine.
1/2 an hour after receiving the shot..I arrived home and began to experience heart palpitations and irregular heart beats. This continued until 3 a.m.The next day the same event occurred at apx.3 p.m.for a few hours. This happened again at apx. 8 p.m. and continued for 4 hrs.The third and last day..I experienced a few more less intense events.
Information has been received from a registered nurse via a company representative referring to a male patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date the patient was vaccinated with his first dose of GARDASIL 9 (dose, lot #, expiration date, site of administration not reported) intramuscularly for prophylaxis. Within 15 minutes after administration, the patient experienced lip swelling. The patient sought medical attention in office and was treated with oral diphenhydramine hydrochloride (BENADRYL). The patient recovered while still in the office. No product quality complaint (PQC) was involved. Additional information has been requested.
Received immunizations Wed 9/3. Yesterday am when he got up c/o of arm hurting. Mom noted Lt upper arm to be swollen/red. No temp. Red area 10x8cm with swelling from shoulder to elbow. Mom called today due to increase in size of redness/swelling.
Cough and wheeze started the day after FLUMIST this yr. Similar sxs last yr after FLUMIST. (Pt not seen for that complaint last yr).
EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022 and expiry: 25-MAY-2021) dose was not reported, administered on 27-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 27-MAY-2021, the subject experienced expired vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine administered was not reported. This report was non-serious.
about 10 seconds after administration patient convulsed twice and fainted lasting 5-7 seconds.  was confused and pale but alert. recovered within minutes.
Patient reported swelling and redness after hours after vaccine.  Seen at clinic 24 hours after vaccine with significant swelling in deltoid, redness.  No fever, chills.  Patient did not appear ill.
Pt. was given the pneumococcal and hib vaccinations and had a bad reaction. She cried and cried for hours, she didn't drink very much breast milk, and by the third day in the morning she was non responsive and almost died. She was intubated for 4 days, her sodium and potassium levels were very low, and she had seizures. She also has brain damage because of this episode. At the time she was just over 4 pounds.
This spontaneous report was received from a Nurse Practitioner referring to a 12 year old male patient. The patient had no medical history, concurrent conditions, concomitant medications, and historical drugs reported. In July 2018 (reported as "last week"), the patient was vaccinated with GARDASIL 9 intramuscular route (frequency, anatomical location, lot # and expiration date were unknown) for prophylaxis. On the same date of the vaccination the patient returned to the office where she was vaccinated, because she developed erythema and swelling at the injection site. Nurse Prescriber stated the patient was treated with ibuprofen and BENADRYL. No laboratory diagnostics or studies were performed. At the time of the report, the outcome of injection site erythema and injection site swelling was reported as resolved. The Nurse prescriber did not mention the causality assessment between the events and GARDASIL 9 vaccination.
This case was reported by a nurse via call center representative and described the occurrence of injection site swelling in a 4-year-old male patient who received KINRIX (batch number 3425B, expiry date 17th April 2018). Concomitant products included MMRV. On 29th November 2016, the patient received KINRIX (intramuscular) 0.5 ml. On 30th November 2016, 1 days after receiving KINRIX, the patient experienced injection site swelling and injection site redness. On an unknown date, the outcome of the injection site swelling and injection site redness were unknown. The reporter considered the injection site swelling and injection site redness to be probably related to KINRIX. Additional details were provided as follows: This case was previously reported to health department. At 8:47 hours, the patient received a dose of KINRIX on her left arm. On the same day, the patient concomitantly received MMRV (non-GSK) vaccine on her right arm. The batch number reported for MMRV was M026879 with expiry date as 27th November 2017. On 1st December 2016, two days after receiving the vaccination, the mother brought the patient back to the physician's office because the upper part of his left arm was swollen and red. These symptoms started the day after the vaccination and were unchanged at the time of the appointment. The physician was also notified about this situation. Further details were unable to obtain. The reporter's call was transferred to Medical Information (MI). The reporter also reported similar adverse events for 4 other children (see cases US2016180181, US2016180183, US2016180271 and US2016180187) that received the same lot of KINRIX vaccine.
Pt was given a HIB vaccination with the incorrect diluent. It was given with sterile water instead of the diluent provided with the vaccination. Age of patient at time of event: 3 years 8 months.
Left outer deltoid, red, hot, swollen, area sore, painful to touch.  No fever.  Received Varicella given on 06/25/2003.
Patient states two days after receiving the vaccine, the area around her elbow became red, swollen, and itchy overnight. She said she had minor swelling and muscle soreness at injection site (upper deltoid) one day following injection (resolved after a day) and the elbow swelling didn't present until 2 days later. Upon checking package insert, I let patient know that her reaction is not likely due to the vaccine since it was further down the arm. Advised patient to go to urgent care if it does not improve by the following day. I called her on 10/10/20 to check on her and she states that swelling, itching, and redness went down considerably and is no longer uncomfortable after using cortisone cream.
Only had right arm soreness until around 10pm. Around 10pm had a headache, upset stomach and neck was achy. Woke up around 3am with chills off and on for about an hour, achy  all on right side of my body, and had a bad headache.
18+ days of full body aches, night sweats, chills, extreme fatigue, intermittent sore throat
Developed a fever 101 on 9/9 increased 102 feeling dizzy and c/o headache, shaking and chills with fever
Patient had swollen eyes to the point where she could not see shortly after receiving the Pfizer vaccine.
Phlebitis, UrticariaPruritus, ONE WEEK POST VACCINE, INJECTION SITE WITH REDNESS/BRUISING, SWELLING, AND ITCHING Narrative:
Information has been received from a nurse practitioner concerning an approximately 21 year old female who in April 2008 was vaccinated with a dose of GARDASIL, (unknown if 1st or 2nd dose). There was no concomitant medication. After receiving her first and second dose the patient experienced breathing difficulty, shortness of breath and severe headaches. The symptoms resolved by themselves 2 hours after the vaccinations. The patient has not received the third dose. Additional information has been requested. Follow up information received on 26-JAN-2009 stated that the patient came for a third dose of GARDASIL. Patient mentioned that she had some difficulty breathing and severe headache after her second dose. The reporter stated that the patient did not receive the third dose of GARDASIL. No further information is available.
Administer expired vaccine to 450 patients after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to 450 patients after the manufacture date of expiration) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to 450 patients after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to 450 patients after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information provided.  Total of 102 doses/vials were given for LOT  026C21A. The vial did not undergone to any temperature excursions.  No treatment medication information provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Live Follow-up received contains non significant information
15 mins after injection of Pfizer covid vaccine dose #1, pt. reported tingling of left hand/wrist up to elbow.  No improvement with walking or water intake.  Was placed supine; BP 110/70, heart RRR.  Vein enlargement of left forearm was noted & ice applied to area with improvement in tingling.  After 15 mins pt. left ambulatory w/daughter, who was driving.  Advised Advil for sx relief and report to her dr. if worse.  Next day pt. stated arm is not tingling but vein remains swollen.  She did not take Advil or see her dr.  Pt is resp. therapist and works in hospital and states has access to a dr. if needed.  Failed attempt to f/u in 60 days; could not reach pt. at either number provided.
pt recvd vax on 8APR93 & 12APR93 pt devel a diffuse, maculopapular, vesicular rash over entire body;
localized injection sight reactions including symptoms of itchiness. patient showed the injection site today and it appears wound like with a scab
This spontaneous report as received from a certified Medical Assistant refers to multiple unspecified patients of unknown age and gender. On unknown dates the patients were vaccinated with LIQUID PEDVAXHIB (lot #, dose and route not reported) that was stored improperly. No adverse effects reported. This is one of several reports received from the same reporter. Additional information is not expected (Reporter refused additional contact).
Ringing started in my left ear within 48 hours of 2nd vaccination shot (same side as injection arm).  The ringing has been persistent, continuous, and continues today, three and one half weeks after receiving the second dose.  The ringing has NOT been accompanied with other sinus related symptoms, like congestion, stuffy nose, etc.  I have experienced a mild plugged-ear like symptom in my right ear, but not ringing in the right ear.  This also persists today.  The intensity of the ringing in my left ear varies slightly from time to time, without any understood correlation.  The ringing intensity is high enough to impact my hearing of conversational speech, but not so severe to impact sleeping. Overall, the intensity of the ringing  has not diminished, and may even be increasing slightly.  I have not received any medical advice yet, but plan to make an appointment with my doctor as soon as possible.
Benadryl 25mg IM given - Right deltoid per standing order and pharmacy due to neck and chest hives after 15 minute holding period. Patient states itching, denies shortness of breath or difficulty breathing. Per DR- no second dose. Benadryl administered at 1030- holding period for 30 minutes, will monitor. BSN, RN
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Mar2021 as dose 1, single (Lot number: en6205), in left arm, on 02Apr2021 as dose 2, single (Lot number: er8734), in left arm, on 11Oct2021 as dose 3 (booster), single (Lot number: fh8020), in left arm and on 10May2022 as dose 4 (booster), single (Lot number: fj4991) at the age of 73 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Low thyroid" (unspecified if ongoing); "occasional asthma" (unspecified if ongoing); "gluten intolerant" (unspecified if ongoing); "osteoarthritis" (unspecified if ongoing); "IBS" (unspecified if ongoing); "Known Allergy: penecillan" (unspecified if ongoing); "Known Allergy: dust" (unspecified if ongoing); "Known Allergy: grass" (unspecified if ongoing); "Known Allergy: trees" (unspecified if ongoing); "Known Allergy: Lidocain" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jun2022) positive, notes: Home test; (30Jun2022) Negative, notes: 4 days after stopping Paxlovid. Therapeutic measures were taken as a result of vaccination failure, covid-19. From 21Jun2022 to 26Jun2022, the patient received nirmatrelvir; ritonavir (PAXLOVID) for treatment of COVID-19. The patient took nirmatrelvir; ritonavir for 5 days after testing positive using at home test. Symptoms were mild: headache and nasal congestion, sneezing and sore throat.Tested was negative on 30Jun2022 (4 days after stopping Paxlovid).  On 04Jul202 02:00 (8 days after stopping Paxlovid), the same symptoms returned and were much worse than my initial symptoms.
Nausea, Headache and diarrhea that started after 2nd vaccine. Also has myalgias, fevers, and body aches on saturday after the shot. Temp up to 101. Took aspirin with improvement. concerned about wheezing, sob, and intermitten cough
Registered Nurse administered Flu shot and there were no immediate issues - The following morning my shoulder was sore it got progressively worse. Range of motion is limited, waking up at nite due to
Chills, nausea/vomiting, cold sweats experienced within 24 hours of flu shot given.