chrisvoncsefalvay/vaers-outcomes huggingface dataset:
occasionally itches  injection site; mild soreness around injection site; swollen injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PRURITUS (occasionally itches  injection site), INJECTION SITE PAIN (mild soreness around injection site) and INJECTION SITE SWELLING (swollen injection site) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Wheelchair user.   On 24-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. In February 2021, the patient experienced INJECTION SITE PRURITUS (occasionally itches  injection site), INJECTION SITE PAIN (mild soreness around injection site) and INJECTION SITE SWELLING (swollen injection site). At the time of the report, INJECTION SITE PRURITUS (occasionally itches  injection site), INJECTION SITE PAIN (mild soreness around injection site) and INJECTION SITE SWELLING (swollen injection site) outcome was unknown.            No relevant concomitant medications were reported.  No treatment information was provided. Action taken with mRNA-123 is not applicable.
Increase in frequency and severity of migraines starting one week after 2nd dose and has lasted for over 6 weeks
On the 6th day after vaccine, woke up with itchy skin rash.  Have some raised bumps, other areas are just red. Antihistamines (Zyrtec) help, but still going on now  3 days later.  Not localized to one location - both arms, stomach, neck, knees, elbows, underwear line.  Wrist, stomach, knee are the itchiest locations.
This case was reported by a physician via sales rep and described the occurrence of arm pain in a 29-year-old female patient who received BOOSTRIX (batch number AC52B102AA, expiry date 19th March 2015). Co-suspect products included FLUARIX QUADRIVALENT (batch number 2KJ3T, expiry date 25th June 2015). Previously administered products included Flu vaccine (no reactions). Concomitant products included Birth Control Pill, levothyroxine and Muscle Relaxant. On 5th September 2014 11:30, the patient received the 1st dose of BOOSTRIX (unknown) .5 ml. On 5th September 2014, the patient received the 1st dose of FLUARIX QUADRIVALENT (unknown). On 6th September 2014, 1 days after receiving BOOSTRIX and FLUARIX QUADRIVALENT, the patient experienced arm pain (serious criteria disability and clinically significant/intervention required) and restricted movement in arm. The patient was treated with cortisone and ALEVE. On an unknown date, the outcome of the arm pain and restricted movement in arm were not recovered/not resolved. It was unknown if the reporter considered the arm pain and restricted movement in arm to be related to BOOSTRIX and FLUARIX QUADRIVALENT. Additional details: The patient had any relevant medical history and previous vaccinations went uncomplicated. The reporting physician stated the patient received the FLUARIX in the left arm, and the BOOSTRIX in the right. The patient reported the FLUARIX was given in the right, and BOOSTRIX in the left. Also, the physician has 2 practices within the same county. The AE was reported to the rep during a visit at the address listed above. It is not known at time of report which office the patient received the injections. The patient reports a Grade 2 level pain in the left arm, with restricted movement. The physician saw the patient on September 15th, and the patient was given a cortisone injection in the affected arm and told to take ALEVE twice a day. The reporter also mentioned that the patient received the injections using a 1 inch 22 gauge needle. Follow-up information received on 08 October 2014 from the physician: BOOSTRIX and FLUARIX QUADRIVALENT were given concomitantly in different arms. Less than a week after the vaccination with BOOSTRIX and FLUARIX QUADRIVALENT the patient experienced pain at injection site which prolonged to 30 days. The physician does not feel that the injection site pain was vaccine related but wanted to know of any case reports of subacromial bursitis or continued deltoid pain were received. No additional information provided.
Following my second dose on 2/8/21, I developed acute pancreatitis and Mesenteric panniculitis around 3/4/2021. Following my third dose on 7/22/22, I developed Mesenteric panniculitis again in early March of 2022.  My fourth dose of Pfizer was on 7/25/22 and beginning on 8/8/22 I am again having symptoms consistent with Mesenteric panniculitis.  When I developed pancreatitis in 2021, my doctors were not able to identify a specific cause such as medication or alcohol (I don't drink).
A nonserious report of expired dose of vaccine administered has been received from a physician concerning a four-year-old male patient. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FluMist. Neither medical history nor concomitant medications were provided. The patient received FluMist on an unknown date. The FluMist had expired on an unknown date. The reporter indicated that no adverse events have occurred since the time of the report. Rechallenge is not applicable to this adverse event. The reporter provided no causality assessment for the event. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.
On day 3 I started having severe body aches and started running a 102.7 fever. Day 4 severe headache and ear ache, nausea and throwing up. The following Monday I went to the doctor and was teated negative for flu and strep. Still have body aches, nausea, headache, and fatigue. Today I broke out in a rash all over my body.
Red circle around injection site-painful, itchy and burning (approximately 2 inches in diameter).
Muscle weakness ,  diarrhea, and fatigue lasting 48 hours. Developed rash on face,  both arms, and both legs 24 hrs following vaccination.  The rash is still present  on day four,  even with two days worth of Benadryl and Tylenol consumed.
March 17, 2023 Received first dose of Shingrix vaccine. April 11-14, 2023 acute gastroenteritis, diarrhea and fever of 103 F. April 19, 2023 Fell in driveway at home due to weakness. April 20, 2023 Admitted to Hospital. Working diagnosis of Miller Fisher variant  GBS (AIDP) or possible seronegative neuromuscular junction disorder.  May 23, 2023 Transfer to another Hospital intensive inpatient rehabilitation
Migraine, fatigue, soreness, dizziness, lost vision in right eye with extreme head pressure, loss of smell
I have been having very strange dreams after my vaccine.  Nightmares really. They began the night of the vaccine. There wasn't treatment necessary. The dreams were very lucid and frightening. Scary and real to the point of putting me in distress all day. I thought I should  report it. Others may want to prepare for this. They lasted for a week same dream over and over.  I am not sure the details of the dream of matter.  The short version ...I dreamed of large parasite type worms coming out of my back on the left side.
Information has been received from a health professional concerning a 73 year old female who on 17OCT05 was vaccinated with a dose pneumococcal 23v polysaccharide vaccine. The same day, 17Oct05, the pt c/o local redness and swelling 4 inches in diameter, and warm to touch at site of injection. Unspecified medical attention was sought. Cold compresses were ordered as well as acetaminophen (Tylenol) and diphenhydramine hydrochloride (Benadryl). At the time of the report the pt was recovering. There was no product quality complaint involved. The pt's events were considered to be other important medical events by the reporter (OMIC). Additional information has been requested.
aches; sore throat; congestion; cough; Mild arm pain; some fatigue; This is a spontaneous report from a contactable consumer (Patient). A 67-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 04Mar2021 09:00 as 1ST DOSE, SINGLE DOSE for covid-19 immunisation (Age at the time of vaccination 67 year). The patient medical history was not reported. Concomitant medication included oxcarbazepine (TRILEPTAL); losartan; dulaglutide (TRULICITY). Patient did not receive any other vaccine in four weeks. The patient experienced mild arm pain, some fatigue on 04Mar2021 and patient experience aches, sore throat, congestion, and cough on an unspecified date. It was reported patient experienced Mild arm pain and some fatigue for two days following injection. On 4th day following injection, aches, fatigue, sore throat, congestion, and cough all for 2.5 days. Patient did not receive any treatment for the events. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 09Mar2021 Nasal swab. The outcome of event were recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Extreme exhaustion, fatigue, nausea 1pm 6/14 Swelling of extremities, severe itching in arm pits, crotch and under breasts 4pm 6/14 Rash, hives over entire body, severe itching, trouble breathing, swollen throat and tongue 5pm 6/14 Emergency room 5:30pm 6/14
Patient developed fever of 102 degrees, body aches, lymph nodes swollen and hard.
Hurt to even swallow water. I have GERD and Shotsky?s ring. Ended up taking 100mg if Omeprozole during the entire day (then Gaviscon Extra Strength. I had to talk to the on call Dr. 2x. After taking the Gaviscon,  I burped and had excruciating pain at the base of my esophagus, broke out in sweat and almost passed out. I had to breathe as if I?m labor. It happened again about an hour later. The Dr. said it could be a cardiac issue and go to the ER. I ended up with normal EKG?S and normal bloodwork during the time I spent  the nite for observation. The cardiologist said  I had no heart issues and to go home. I can only come to the conclusion that the inflammatory response from the vaccine was the culprit.
Pulmonary Hypertension; flu-like symptoms; This is a literature report.  A 49-year-old male patient received BNT162b2 (BNT162B2), in Jan2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "non-smoker" (ongoing); "mild exercise-induced asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Albuterol for mild exercise-induced asthma. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), administration date: Dec2020, for COVID-19 immunisation. The following information was reported: PULMONARY HYPERTENSION (medically significant, life threatening) with onset 2021, 3 weeks after the suspect product(s) administration, outcome "recovering"; INFLUENZA LIKE ILLNESS (medically significant) with onset 2021, 3 weeks after the suspect product(s) administration, outcome "recovering", described as "flu-like symptoms". The patient underwent the following laboratory tests and procedures: Body mass index: (unspecified date) 23; Brain natriuretic peptide (normal high range 900): (unspecified date) 22 pg/mL; Computerised tomogram thorax: (unspecified date) with 3D reconstruction of the PA tree was normal w, notes: evidence of pulmonary clots; Echocardiogram: (unspecified date) showed no worsening, notes: of RVSP and continued normal RV function; (unspecified date) revealed normal left ventricular function with an, notes: ejection fraction (EF) of 65%, normal right ventricular size and function; Ejection fraction: (unspecified date) 65 %; Haematocrit: (unspecified date) 50 %; maximal tricuspid regurgitation velocity: (16Feb2021) 3.09, notes: Units: m/s; (24Feb2021) 3.1, notes: Units: m/s; (18Mar2021) 3.0, notes: Units: m/s; (21Apr2021) 2.9, notes: Units: m/s; (17Jun2021) 3.1, notes: Units: m/s; (15Feb2022) 3.2, notes: Units: m/s; Low density lipoprotein: (unspecified date) elevated; NYHA classification: (unspecified date) 3-4; (unspecified date) 1-2, notes: over one year; Oxygen saturation: (unspecified date) 92 %; (unspecified date) 98-100 %; Right ventricular systolic pressure: (16Feb2021) 42 mmHg; (24Feb2021) 42 mmHg; (18Mar2021) 39 mmHg; (21Apr2021) 38 mmHg; (17Jun2021) 42 mmHg; (15Feb2022) 45 mmHg; SARS-CoV-2 test: (unspecified date) Negative, notes: at the time of the onset of these symptoms.; Sender's Comments: Based on the information available, a possible contributory role of the suspect drug for the reported events Pulmonary hypertension and Influenza like illness cannot be excluded. This impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202300293682 Same article/ drug/event and different patient;
Red, scabbed rash at waist on back - painful - required MD visit. Pt. now on VALTREX Dx: Shingles.
Several days after vaccination I experienced chronic diarrhea. It has been ongoing for 3 weeks.
Itching all over body getting worse in past few hours, took 2 doses of BENADRYL with no relief. Itching started 9/18/13 until informed reactionas usually occur a few hours after administration then changed story to say itching began 9/17/13. Patient may be going to ER for treatment. Has had flu shot in past with no problems. No egg allergies.
Subsequent to receiving the third dose of Lymerix, the pt experienced symptoms of gastroesophagal reflux disease. These did not cause hospitalization or disability. The reporter considered the event to be probably unrelated to Lymerix, and attributed the temporal relationship to coincidence. As of 11/17/2000, the outcome is ongoing.
Two days after received pneumovax and shingrix, patient developed generalized weakness associated with fever, chills, myalgias, and arrhythmia.  He was admitted to Medical Center and discharged two days later.  He is now doing ok.  He was diagnosed with vaccine adverse reaction.
Chills; chest tightness; minor fatigue; joint and muscle pain throughout the body (injection site in upper left arm; shoulder; back; ankles). Injection site soreness began immediately after the vaccine, but is normal for me. Everything else began at time listed on this form (1/25/2021 afternoon) and ended by the following morning. I took one Tylenol to help with the chills and pain about 5 hours after symptoms started and it seemed to help a little.
She states she has developed a small non-pustule rash on her arms, legs, torso. She describes the rash as pale pink edges with white color in the middle. She states her injection site at YF developed same presentation several days after vaccination. She denies any itching, shortness of breath, hives, chest pain, swelling
she has not taken 2nd dose; Feeling really sick; chest hurts; Nausea; body ache; Arm started hurting; no energy; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm started hurting), ASTHENIA (no energy), ILLNESS (Feeling really sick), CHEST PAIN (chest hurts) and NAUSEA (Nausea) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 04GA21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm started hurting), ASTHENIA (no energy), NAUSEA (Nausea) and MYALGIA (body ache). On 22-Mar-2021, the patient experienced ILLNESS (Feeling really sick) and CHEST PAIN (chest hurts). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (she has not taken 2nd dose). At the time of the report, PAIN IN EXTREMITY (Arm started hurting), ASTHENIA (no energy), ILLNESS (Feeling really sick), CHEST PAIN (chest hurts), NAUSEA (Nausea), MYALGIA (body ache) and PRODUCT DOSE OMISSION ISSUE (she has not taken 2nd dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported. Treatment information were  reported by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: TCR
9/19 PNEUMOVAX IM - R delt.  9/20 - Pt developed severe pain/blister -> adm to hosp -> necrotizing fasciitis -> surgical debridement -> 9/24 wound closure -> persistent pain, decreased ROM.  11/14/08 Reviewed hospital medical records of 9/20-9/25/2007 & 11/2-11/7/2007. FINAL DX: RUE soft tissue infection; surgical debridement & wound closure; complex regional pain syndrome Records reveal patient experienced painful blistering reaction over right deltoid after vaccination.  Taken to OR for debridement or right deltoid/shoulder in 9/2007.  Returned to hospital for increased pain & weakness of right shoulder into the neck, chest & down the arm, fever, chills.  Neuro, rheum & pain consults done.  Improved pain mgt, strength & ROM at d/c to home on continued PT & to f/u w/neuro, rheum & pain clinics. 1/27/2010 Persistent arm pain.
2 days after 1st Pfizer covid shot, patient had swollen/itchy hands and lips/mouth.  Patient took Benadryl and he was fine afterwards
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant therapies and drug reactions/allergies were not reported. On 24-OCT-2018, the patient was vaccinated with an expired dose of VAQTA intramuscularly (lot # N020689 and expiration date 22-OCT-2018) for prophylaxis. No adverse effect was reported.
Systemic: Fainting / Unresponsive-Severe, Additional Details: Patient received 3rd dose of Pfizer Covid vaccine.  Upon walking away from the vacccination area, patient fainted.  Patient hit head and chin on base of the Target end cap. Immunizer RN, responded immediately.  Assessed the patient, 1 inch laceration on lower left chin, bleeding, weak pulse.  Patient said she was seeing black dots, so activated the EMS and called 911.  Paramedics arrived and took over care.  Called patient tonight to check on her, and her dad said she was in the ER.
Information has been received from a nurse practitioner concerning an 8 week old white male who on 14-FEB-2007 was vaccinated with the first dose of RECOMBIVAX HB (Lot # 653268/0223F) in the right thigh. Concomitant therapy included pneumococcal conj vaccine (unspecified), poliovirus vaccine, Hib conj vaccine (unspecified carrier) and diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid. On 14-FEB-2007 the patient developed facial flushing with macules. Subsequently, the patient recovered within 10 to 15 minutes without intervention. Additional informtion has been requested.
Spoke with father of patient on 11/30/22 and he stated that patient is doing well no secondary side effects noted.
mom says pt cried (screamed) x 5 hrs p/inject & was inconsolable (crying); 18JUN94 dx w/pharyngitis 19JUN94; t101.6;
Information has been received from a registered nurse concerning a 9 year old white female with cefdinir (OMICEF) allergy, sulfa allergy and urinary reflux who on 16-AUG-2002 was vaccinated with the first dose of varicella virus vaccine live (Oka/Merck). On 03-AUG-2007 was vaccinated with the second dose of varicella virus vaccine live (Oka/Merck) (Lot #652868/0267F) SQ in the left deltoid. There was no concomitant medication. There was no illness at the time of vaccination. On approximately 04-AUG-2007 (24-48 hours after vaccination) the patient experienced red raised bumps (papules, not fluid filled) at the injection site. The registered nurse reported that a rash broke out at the deltoid area. There was itching to the area. The area lasted less than five days in length. The patient did not have a temperature. No treatment was administered. No diagnostic laboratory test were performed. The nurse called because they wanted to if the site was contagious to others and if it was truly a pox. Medical attention was sought. Subsequently, the patient recovered. No further information has been requested.
Expired vials were used to provide 38 doses; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vials were used to provide 38 doses) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vials were used to provide 38 doses). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vials were used to provide 38 doses) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment information was not provided.  No vial went any temperature excursions.   Most recent FOLLOW-UP information incorporated above includes: On 19-Nov-2021: Non Significant Follow Up Appended with Second reporter Information in case
Pt experience stroke-like symptoms within 1 hours of receiving vaccine and went to the ER. They ran tests and everything came back WNL. Pt was unable to speak and had weakness on the side of the vaccine. Pt is doing fine now. ER doctors said it was related to vaccine.
Child was give 2 flu Vaccines and a 3rd Hep A.No reaction at the site,No adverse reactions noted.
Pain, slightly swollen, develop lump approx. 2 cm on right deltoid.