chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a male patient who received SHINGRIX for prophylaxis. On 19th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In May 2018, less than a week after receiving SHINGRIX, the patient experienced injection site erythema. On an unknown date, the patient experienced injection site pain and local swelling. On an unknown date, the outcome of the injection site pain, injection site erythema and local swelling were recovering/resolving. The reporter considered the injection site pain, injection site erythema and local swelling to be probably related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. Approximately 16 days before the date of reporting, the patient received SHINGRIX in the left arm. Less than a month after vaccination, the patient experienced injection site soreness and raised bump. The patient also stated there was a small raised area towards the back area of the arm which was about less than the size of half inch by half inch. The redness was dominant for the first week after receiving the shot, and it had subsided a lot more than initially. The patient had denied permission to contact their physician. All questions were asked; no further details were provided.
Thighs are in pain, agony of pain in legs; Burning feeling in the skin; Locked up in pain; Joint pain/ joint got worse/ burning in joints; Chills; More than 36 days after the first dose without receiving second dose; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Thighs are in pain, agony of pain in legs), SKIN BURNING SENSATION (Burning feeling in the skin), CHILLS (Chills), MYALGIA (Locked up in pain) and ARTHRALGIA (Joint pain/ joint got worse/ burning in joints) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039B21A and 047A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Knee replacement (Bilateral knee replacements (synthetic knees)). Concurrent medical conditions included Deep vein thrombosis. Concomitant products included APIXABAN (ELIQUIS) for DVT, ROSUVASTATIN CALCIUM (CRESTOR) for an unknown indication.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 36 days after the first dose without receiving second dose). On 01-May-2021, the patient experienced CHILLS (Chills). On 02-May-2021, the patient experienced PAIN IN EXTREMITY (Thighs are in pain, agony of pain in legs), SKIN BURNING SENSATION (Burning feeling in the skin), MYALGIA (Locked up in pain) and ARTHRALGIA (Joint pain/ joint got worse/ burning in joints). The patient was treated with PARACETAMOL (TYLENOL) for Pain relief, at an unspecified dose and frequency and OXYCODONE for Pain relief, at an unspecified dose and frequency. On 01-May-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 36 days after the first dose without receiving second dose) had resolved. On 02-May-2021, CHILLS (Chills) had resolved. At the time of the report, PAIN IN EXTREMITY (Thighs are in pain, agony of pain in legs), SKIN BURNING SENSATION (Burning feeling in the skin), MYALGIA (Locked up in pain) and ARTHRALGIA (Joint pain/ joint got worse/ burning in joints) outcome was unknown.            Most recent FOLLOW-UP information incorporated above includes: On 04-Jun-2021: Follow-up was received on 4-Jun-2021 and included email updates
my tongue has been burning since my second shot/ tongue also had a burning sensation; tingling a little later/ tongue started tingling; her tongue feeling a little funny; This is a spontaneous report from a contactable consumer (patient). A 73 years old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), at same age, via an unspecified route of administration, administered in arm on 26Feb2021 as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), at age of 73 years old for covid-19 immunisation on 05Feb2021 and experienced sore arm. The patient experienced her tongue had been burning since her second shot on 27Feb2021 with outcome of not recovered, her tongue feeling a little funny on 26Feb2021 with outcome of unknown, tingling a little later on 27Feb2021 with outcome of unknown. Patient stated that with the second vaccine, when she was waiting to leave, she became, aware, of her tongue. By the next day, her tongue started tingling and her tongue also had a burning sensation. She did check with her doctor's office and called her doctor. The doctor recommended taking Benadryl for 3 days, and she stated that her reaction did not go away. She took one gel cap the first day, and then called her pharmacist, who told her to take 2 gel caps a day. She had a regularly scheduled appointment with her doctor. At the appointment, the doctor suggested she try steroids, reclarified as she followed the specific dose schedule. After taking the steroids, there was still a burning sensation. She did not know the name of the steroid. Her doctor thought her reactions would go away, and she stated they were livable, and not painful.   Follow up (15Apr2021): New information received from a contactable consumer includes: patient details and event details.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
2 days ago had nasal H1N1 vaccine. Later that same day started feeling unwell productive cough, sore throat, myalgia, headache. No fever
Patient presented to emergency room on 11/26/2021 with fever, headache, nausea, diarrhea, and shortness of breath. Patient was found to be COVID-19 positive and admitted for further management. Patient was started on supplemental oxygen and dexamethasone. Patient was discharged home on 11/27/2021.
Information has been received from a nurse practitioner concerning a 49 year old female with an allergy to sulfa drugs who on 1/9/04 at 10:30 AM was vaccinated IM in the right deltoid with a first dose of pneumococcal 23v polysaccharide vaccine (lot # 646322/0530N). There was no illness at the time of vaccination. On 1/12/04 in the PM, the patient developed a cellulitis at the injection site. Erythema and induration at the site were noted. The patient had a fever of 102 degrees F for 1 day. Diphenhydramine hydrochloride was given and the erythema was gone after one day. The induration remained and the patient was prescribed amoxicillin (+) clavulanate potassium 875mg BID for 10 days. The outcome was reported as recovered on 1/28/04. There were no diagnostic tests or laboratory data. There were no adverse events following prior vaccinations for the patient or her siblings. Unspecified medical attention was sought. There was no product quality complaint. The reporter indicated that one other patient developed a cellulitis. No further information is expected.
Received vaccine in seated position. Upon standing one minute later she experienced a syncopal episode followed by brief generalized tonic-clonic activity. Total duration of LOC less than one minute. No loss of bowel/bladder control or postictal state. She was evaluated in the ER due to having struck her head as she fell. She was observed in the ER and released to home.
Felt very tired and achy starting a few hours after vaccine. The next day felt really awful (tired, dizzy, muscle aches) and the second night slept horribly (hot, bad headache) and woke 4/16 am with a rash on chest, back, neck and under right eye.
Injection site soreness after first dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Injection site soreness after first dose) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-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 VACCINATION SITE PAIN (Injection site soreness after first dose). At the time of the report, VACCINATION SITE PAIN (Injection site soreness after first dose) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No relevant concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD-2021-268129 (Patient Link).   Reporter did not allow further contact
Received Pneumococcal vaccine 12/3/08- Called on 12/5/08 to report extreme arm tenderness, with red streaks down right arm, (also reported achiness and chills).   Pt made appt. with her doctor that day- no treatment or meds given.  On 12/8, patient reported arm much better.
Initial information received on 19-Mar-2019 regarding an unsolicited valid non-serious case received from a consumer/non-HCP. This case involves a patient of unknown demographics who experienced moderate to serious side effects with myalgia, while he/she received vaccine DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. In November 2018, the patient received a dose of suspect DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site. On an unknown date, the patient developed a non-serious moderate to serious side effects with myalgia following the administration of DIPHTHERIA and TETANUS AND ACELLULAR PERTUSSIS VACCINE. Patient had to visit emergency room at the Hospital. Lab test not reported. Final diagnosis was moderate to serious side effects with myalgia. It was not reported if the patient received a corrective treatment. The patient outcome was reported.
Information has been received from a health worker (medical assistant) referring to a patient of unknown age and gender. The patient's pertinent medical history and concurrent condition were not reported. On 06-AUG-2015 the patient received a dose of improperly stored PEDVAXHIB injection (strength, route, lot# and expired date were unknown). No adverse experience reported. There were no product quality complaints (PQC) involved. Additional information has been requested.
COVID-19; COVID-19; On 15Mar2021, he received 1st doseCovid-19 Vaccine/15May2021, patient received 2nd dose Covid-19 Vaccine;   This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4245037-00.  A 22 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date 15May2021 (Batch/Lot number: unknown) at the age of 22 years as dose 2, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Lot number: 1156743) for ankylosing spondylitis. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose:01, Route of Admin: Intra-muscular), administration date: 15Mar2021, when the patient was 22 years old, for COVID-19 Vaccination, reaction(s): "COVID", "COVID". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID-19"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 15May2021, outcome "unknown", described as "On 15Mar2021, he received 1st doseCovid-19 Vaccine/15May2021, patient received 2nd dose Covid-19 Vaccine". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive. The action taken for adalimumab was unknown.  Additional Information: an event of non-serious Covid with Humira (adalimumab). On an unknown date, the patient experienced covid. Pfizer biontech covid-19 vaccine (tozinameran) was also considered suspect. It was unknown if patient was enrolled in a Covid-19 Vaccine Trial. On 15Mar2021, he received 1st dose Covid-19 Vaccine manufactured by Pfizer/BioNTech. On 05May2021, patient received 2nd dose Covid-19 Vaccine manufactured by Pfizer/BioNTech. On 05Sep2021, patient received 3rd dose Covid-19 Vaccine manufactured by Pfizer/BioNTech. Causality for HUMIRA (ADALIMUMAB). The reporters causality for the event(s) of COVID with HUMIRA(ADALIMUMAB) was no reasonable possibility. Causality was reported as, for HUMIRA(ADALIMUMAB): COVID-19 (COVID-19) Causality as per reporter (Drug/Vaccine): No reasonable possibility. For PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN): COVID-19 (COVID-19) Causality as per reporter (Drug/Vaccine): Possible.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the drug ineffective (LOE) cannot be ruled out.
covid 19; covid 19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 90-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Dysphagia" (unspecified if ongoing); "Dementia" (unspecified if ongoing). Concomitant medication(s) included: NAMENDA.The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "covid 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (07May2022) Positive.   clinical course: Therapeutic measures were taken as a result of covid-19.Clinical information: Reporter was informed, in case of Emergency may contact prescribing HCP or the Pharmacy. In response, reporter stated, "Truly I have done both of the thing they don't know any your question, you don't know and Pfizer doesn't know anything beyond what they are publishing then why this medication can't be chewed."  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
No additional AE/PQC.; Inbound call from office manager calling to report administration of VARIVAX that experienced a temperature excursion.  Confirmed no symptomatic adverse events were reported.  VARIVAX was evaluated and found to have a supported temperature excursion.; This spontaneous report has been received from an office manager referring a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported.    On 21-JUN-2023, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX), subcutaneous Injection, lot number W039689 that had been verified to be a valid lot number with expiration date 13-DEC-2024 (strength, specific dosage, vaccination scheme, route of administration, anatomical site of application, lot number and expiration date were not provided) (product storage error).  The vaccina had a temperature excursion of -13.3 C for a time frame of 0 hours 52 minutes 0 seconds (total). A previous temperature excursion occurred, not data logger. No additional adverse event reported.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2306USA011379:
Information has been received from a registered nurse concerning an 8 month old 18.5 pound, 25 inch female, with no medical history and no allergies, who was vaccinated with a first, second, and third 2 ml oral dose of Rotateq on 29-JAN-2007 (Lot# 656101/1231F), 29-MAR-2007 (Lot# 656388/0506U), and 30-MAY-2007 (lot# 656388/0506U), respectively. There was no concomitant medication. There was no reported illness at the time of vaccination. On 06-AUG-2007 (previously reported as 02-AUG-2007), the patient experienced nausea, vomiting, and diarrhea that was diagnosed as rotavirus infection. Follow up information from the physician's office reported that she was seen in the in the office by her physician. On 06-AUG-2007, diagnostic studies obtained were positive for rotavirus (source unspecified), and stool specimens that were negative for leukocytes, ova and parasites, and enteric pathogens. At the time of the report the patient was recovering. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Additional information has been requested.
Booster; feet swelling; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 73 year-old male patient received bnt162b2 (BNT162B2), administration date 18Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First dose: Date of administration/Lot/NDC/Expiry: Not provided), for COVID-19 Immunization; Bnt162b2 (Second dose: Date of administration/Lot/NDC/Expiry: Not provided), for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 18Dec2021, outcome "unknown", described as "Booster"; PERIPHERAL SWELLING (non-serious) with onset Dec2021, outcome "recovering", described as "feet swelling".  Additional information: The report is not related to a study or programme. The caller wanted to know if feet swelling was a known side effect of the vaccine. Response: Spoke from the attached CONS-what are the risks of the vaccine (v10.0), cant find the exact term/description "feet swelling", swelling of lymph nodes or lymphadenopathy has been reported as common side effects of the vaccine. These may not be all the possible side effects of the vaccine. Serious and unexpected side effects may occur. The possible side effects of the vaccine are still being studied in clinical trials. For any specific questions regarding the risks of the vaccine based on your medical condition, please speak with your healthcare provider. Lot/NDC/Expiry of third dose was not provided. He explained that usually when he eats food with lots of salt his feet swell up. Because of that for the last 2-3 weeks he hasn't eaten anything with salt. After he was administered this booster shot on 18Dec2021 he did not have any side effects. His wife did of fatigue; but when he looked at his feet, both feet swelled quite a bit, considerably. He couldn't think of anything he had with salt, but everyday he looked at his feet and they wouldn't go down. When he looked online to see if side effect was swelling it did indicate swelling is side effect. The feet swelling has gone down somewhat at this point; compared to when he first looked when they were considerably swollen, they looked like grapefruit and now look like oranges. When reading he became concerned. He is thinking because he has had no salt intake that the feet swelling is from the booster shot of Pfizer Covid Vaccine. He did not call his physician yet and wanted to know if he should see his physician, or if he was ok.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Developed URI symptoms the week following the injection. Then on the 19th, parents noted a distinct targetoid lesion on the tongue with concentric bright red annular rings. this was non painful. These occurred in the setting of a URI.  Seen in Urgent Care on 12/24. Diagnosed with LLL pneumonia and started on azithromycin. Pictures taken and saved in patients chart for reference. Dermatology reviewed images and felt most consistent with geographic tongue. He continues to improve, but lesions on tongue still present. I have seen a lot of geographic tongue, but never one that has a targetoid appearance.  No other skin findings by report. He is overall healthy now. Planning to get second Pfizer injection tomorrow.
A circle formed near the vaccine site that was red, warm, and itchy one week after receiving it.
Chest/heaviness pain, muscle aches, tiredness, swelling and heat at injection site, and severe headache
patient left hand non-palmar surface, red, + itchy, per patient he wasn't sure if it was itchy prior to receiving vaccine, no labored breathing, no further rashes nor hives noted, not scratching hand post vaccine
Within 15-minutes of vaccination, the patient reported a diffuse pruritic rash with hives, dizziness, blurred vision, and SOB. EMS evaluated the patient on-site. Patient was hypertensive (173/92). EMS administered 50mg Benadryl IV and 2L Oxygen via nasal canula. Given past medical history of allergic reactions, EMS transported the patient to  Hospital Emergency Department. In the ED, the patient remained hypertensive. EKG demonstrated NSR, rate 75bom, no ST-T changes, no ectopy, and normal PR & QRS intervals. Blood work was unremarkable. After administration of Benadryl the patient noted improvement of their hives and was discharged with a diagnosis of allergic reaction secondary to COVID vaccine that caused acute hives.
This is a 51y.o. male with a PMHx of ADD, depression, DMII, dyslipidemia and OSA on cpap who presents to the ED with c/o high blood sugar. Patient states that he was diagnosed with COVID 12/27. States that for the last ~1 week he has been having fatigue, nasal congestion and blurred vision. States he is compliant with his jardiance, metformin and ozempic. States he takes toujeo 10 units as needed, however has not taken it in months. Per chart review, he was to titrate toujeo by 3 units every 3 days until fasting glucose is less than 150. Denies any fever, chills, dizziness, lightheadedness, chest pain, palpitations, shortness of breath, abdominal pain, nausea, vomiting, diarrhea and constipation.
I got out of bed the morning of 09/21/2021 at 07:00am. My body was aching extremely bad. Joints that I previously had pain in were painful as well as joints that I never experienced pain in. I stayed in bed the entire day, I was in a lot of pain I was immobile. The next morning I woke the pain subsided. The pain in my joints has been ongoing since my booster shot. I am currently taking over-the counter medication to help with the pain.
Dad called to the store to say that his daughter had been violently throwing up starting in the morning.  I advised to give her some water when she stopped vomiting to see if she could hold it down and then to call their doctor to see how they wanted to proceed.
Noticed bump, redness on 10/01/14. Pt c/o itchiness. Today patient improved. Measured in office 4x2.
Pt rcvd injection 1/13/00, she was observed 20 mins.  On 1/18/00, pt reported at school she experienced and episode of dizziness while walking. She also had pain and itching at inject site. C/O light headedness and dizziness.
Woke up at 3 AM next day - was so cold - went to bathroom could hardly walk - back to sleep - 7 AM got up - ached terribly all over - walking difficult - had fever, headache very scary. Took hot shower for relief. Read side effects - sure enough - the shot. Call pharmacy + Dr. office - they verified the reaction Slept off + on all day.
H1N1 influenza 5ml vaccine vial made by Sanofi is the same size and has very similar labeling to Sanofi's tuberculin skin test 5ml. Can be confused if left side by side. Medication Error.
Malaise, Rash, Spots on Tongue, Itching - continued through 12/8/09 when reported. Referred to EH/WC physician.