chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Systemic: Body Aches Generalized-Severe, Systemic: Chills-Severe, Systemic: Dizziness / Lightheadedness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: other-Severe, Systemic: Headache-Severe, Systemic: Nausea-Severe, Systemic: Unable to Sleep-Severe, Systemic: Weakness-Severe.
contracted Cov-19 despite having 3 vaccine shots.; contracted Cov-19 despite having 3 vaccine shots.; Experiencing nausea; tiredness; congestion; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 48-year-old 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "contracted Cov-19 despite having 3 vaccine shots."; NAUSEA (non-serious), outcome "unknown", described as "Experiencing nausea"; FATIGUE (non-serious), outcome "unknown", described as "tiredness"; NASAL CONGESTION (non-serious), outcome "unknown", described as "congestion". Covid 19 booster patient contracted Cov-19 despite having 3 vaccine shots. Experiencing nausea, tiredness, congestion. Patient was a healthy 48 year old woman with a demanding job that requires her to travel extensively throughout the country. No underlying diseases or chronic illnesses in medical history. Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Hard warm lump about 2 inches in diameter still. Stiff neck pain same side on 8/21. Difficult to move Neck to same side as lump in arm. Still mild Neck discomfort. Chest pain night of 8/23. Hard lump causes discomfort.  Might have to get it checked soon. Not sure how long this should last or if it's just wait a long time
pt received shingles vaccine friday 6/27 and approximately 2 days later felt burning sensation and broke out in dermatomal rash on forehead/scalp unilaterally
Expanding injection-site erythema ~10x10cm, warmth, and tenderness.
I gave patient the vaccine for meningitis/Bexsero, within a few seconds he was pale and stated he did not feel right,  I got our nurse practioner to come into the procedure room and  he listened to his breathing and noticed red weaps on back of his neck and was itching his face, bp was 112/60, we put patient in supine position and elevated his feet a little above his head, he drank some Dr. Pepper through a straw, we put an ice pack behind his neck, we gave him benedryl 50mg IM right deltoid and Celestone 6mg IM right deltoid, we observed him for an hour or more, his weaps went down and he looked better, felt better and was breathing fine. His throat never closed up or prevented him from breathing. His mom was in room with us, they both went home and was advised go to ER if had any problems breathing or rashes. They verbalized understanding.
Sore after shot then itching, redness, and feels hot started 11/3/15 just on (R) deltoid I.M.
covid 19 symptoms for about 12 hours.  Felt just like when i had it for two weeks.
Client reported fever, chills, migraine-intensity headache, swollen tongue and mouth ulcers after receiving the 1st dose of Moderna on 1/26/2021; referred client to PCP for further evaluation/treatment and encouraged to check in with v-safe if able. Client stated that she was seen by an urgent care facility and given Benadryl and Steroids and encouraged to take a daily antihistamine and follow-up with PCP or ER if s/sx persisted worsened. Client stated that her tongue continued to swell and that she went to the ER where she was treated with IV Steroids and Benadryl. Client stated that she followed up with her PCP and has a follow-up appointment with him on Thursday (2/4/2021). Per Dr - client is NOT TO TAKE THE 2nd DOSE. Client reports that she is still having having side effects.
After vaccine, had flushing and headaches, had GBS, lost all strength in both arms for 3 days, which has not recovered in left arm. Eyes were blurry and  infected, redness and swollen shut, felt like pinkeye which lasted for 4 days. Can feel residual pain in forearm and wrist. Can move left arm now. but still no strength.
Pain in left shoulder area that radiates to left hand, limited range of motion, popping feeling upon movment.
Patient states she had swelling tongue, mouth, chin and cheeks. Took BENADRYL next morning had minimal swelling chin other sx resolved. No other treatment necessary.
I had a lump at injection site on my left arm. I still do. I was and still am unable to use my left arm to fullest capacity. Very limited mobility. I have terrible pain from injection site up to my neck and down to my hand. I cannot sleep on the side due to terrible discomfort in shoulder. I visited my orthopedic doctor, xrays showed nothing remarkable.
Noticed bright red disc-type spots on right leg - counted eight Area appeared swollen and was painful to touch Contacted my physician who looked at them Spots faded 2 days later
Extreme headache, fever, chills, muscle pain lasted approximately 24-36 hours. Followed by neck pain, nausea, dizziness, blurry eyes and inability to concentrate. Primary care doctor thought it was a virus with vertigo, treated by Physical Therapist for vertigo, no improvemnt. Had MRI and sent for follow-up studies. On going at present.
She was nauseas and vomiting. She had a fever. She was prescribed anti-nausea medication. She was sick for about 3 days.
Patient had onset of  numbness in leg while driving home from vaccine appointment.  Subsequently over hours developed numbness in his face and arm.  He did not seek medical attention until 3/19/2021 because he thought this was a side effect that would resolve.  3/19/21 he was seen at Hospital and diagnosed with a CVA.  His symptoms are improved but not resolved at this time.
2 days after the vaccine, the pt developed fever and pain in his calves bilaterally.  Diagnosed with myositis and was treated with IV hydration, mannitol and bicarb in the intensive care unit.
Developed redness, swelling, tenderness at injection site 12 degrees after PCV 13. Area about 3" x 4" size.
13 days ago received VARIVAX, last night noticed red itchy area surrounding the injection site - no vesicular lesions @ this time - advised ZYRTEC too control itching.
Immediately following immunization, patient experienced hives, throat closing, and nausea/vomiting. Patient went to the emergency department and was not admitted to the hospital.
Chest pain; inappropriate dose of vaccine administered; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 80-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Sep2022 as dose 4 (booster), single (Lot number: GH9693) and on 21Sep2022 at 10:15 as dose 5 (booster), single (Lot number: GH9693) at the age of 80 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes type 2" (unspecified if ongoing), notes: Other medical history: Diabetes type 2; "Psoriatic arthritis" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin. Concomitant medication(s) included: ATENOLOL; FOSAMAX. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; Unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (First booster dose, Unknown manufacturer), for COVID-19 immunization. The following information was reported: INCORRECT DOSE ADMINISTERED (non-serious) with onset 21Sep2022, outcome "unknown", described as "inappropriate dose of vaccine administered"; CHEST PAIN (non-serious) with onset 23Sep2022 at 07:00, outcome "recovering". The event "chest pain" required emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of chest pain.  Additional information; Patient was not taken other vaccine in four weeks. Patient had no covid prior vaccination. Patient had covid tested post vaccination. Chest pain on right side two days post vaccination and laster about 24 hours went to emergency room .
Headache, Myalgia, Fever, redness/ fatigue/ chills/ swelling Narrative:  Other Relevant History:
Information has been received from a physician's assistant concerning a 27 year old female with spironalactone allergy who on 05/16/2001 was vaccinated IM in the right deltoid with a first dose of hep b vaccine recombinant. There were no illnesses at the time of vaccination. On 0517/2001 the pt experienced rash and a "hive type reaction" on her trunk, arms, and face. It was reported that the pt treated her hives with Benadryl. It was noted that the pt has not had this type of reaction before. It was reported that the reaction continued until 05/21/2001 (4 days) and that the pt recovered from this experience. It was indicated that on 06/13/2001 the pt received a first dose IM in the right deltoid of hep a virus vaccine inactivated and on 06/28/2001 the pt received a second dose IM in the left deltoid of hep b vaccine recombinant. It was noted that there was no reaction after the second dose of hep b vaccine recombinant. No further info is available.
hot; itchy; the injection site arm swollen; red; it was nothing; it was achy or whatever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (it was achy or whatever), INJECTION SITE WARMTH (hot), PAIN (it was nothing), INJECTION SITE PRURITUS (itchy) and INJECTION SITE SWELLING (the injection site arm swollen) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LOSARTAN, SPIRONOLACTONE, VENLAFAXINE, CARVEDILOL, ATORVASTATIN, POTASSIUM CHLORIDE, METFORMIN, FUROSEMIDE, ACETYLSALICYLIC ACID (BABY ASPIRIN), TRAZODONE and LEVOMEFOLIC ACID for an unknown indication.    On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, the patient experienced PAIN (it was achy or whatever) and PAIN (it was nothing). On 24-Feb-2021, the patient experienced INJECTION SITE WARMTH (hot), INJECTION SITE PRURITUS (itchy), INJECTION SITE SWELLING (the injection site arm swollen) and INJECTION SITE ERYTHEMA (red). The patient was treated with PARACETAMOL (TYLENOL) for Pain relief, at a dose of 1 dosage form. At the time of the report, PAIN (it was achy or whatever), INJECTION SITE WARMTH (hot), PAIN (it was nothing), INJECTION SITE PRURITUS (itchy), INJECTION SITE SWELLING (the injection site arm swollen) and INJECTION SITE ERYTHEMA (red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
developed cellulitis from the vaccines; This is a spontaneous report received from a contactable reporter (Nurse).  A patient (no qualifiers provided) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), in Nov2022 as dose number unknown, single (Lot number: FW6029). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CELLULITIS (medically significant) with onset Nov2022, outcome "unknown", described as "developed cellulitis from the vaccines".; Sender's Comments: A possibly contributory role of PREVNAR 20 in triggering the onset of CELLULITIS cannot be fully excluded, considering the temporal relationship.  The 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 notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate,Linked Report(s) : US-PFIZER INC-202201346421 same reporter, drug and event, different patients;
This spontaneous report was received from a medical assistant regarding unspecified number of patients. Patient demographics were not reported. Information on their concurrent conditions, pertinent medical history and drug allergies were not reported. On an unknown date in March 2016 (starting on or after 09-MAR-2016), the patients were vaccinated with improperly stored PROQUAD (Merck) lot # K018142, expiry date 10-APR-2016, lot # K024765, expiry date 08-JUN-2016, lot # L030585, expiry date 10-FEB-2017 (dose, frequency, route and anatomical location were not reported) (incorrect product storage). Concomitant medication were not reported. No adverse effects were reported. There were no Product Quality Concerns (PQC) involved. Temperature at which the administered product was stored was 9.3 Fahrenheit, there were no previous temperature excursions performed. This is one of several reports received from same reporter. Additional information has been requested.
On 06/15/06, the patient experienced dizziness, headaches, chills but no rash. Husband gave her a half of vicoprofen for the headache. Has not seen physician.
At first injection site itchy and then a rash developed and still there at the injection site since 9-4 to today 10-1-12.
having problems with his nipples where he pushes them down and they get sore; stomach was upset; didn't feel like he wanted to eat; could have hit a nerve in his chest and ribs; nauseous; tired; Initial information received  on 19-Oct-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves a 78 years old male patient who experienced problems with his nipples where he pushes them down and they get sore, stomach was upset, didn't feel like he wanted to eat, could have hit a nerve in his chest and ribs, nauseous and tired while receiving vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's past vaccination(s) included INFLUENZA VACCINE with he has been getting the same flu shot for 8-9 years. The patient's past medical history, medical treatment(s) and family history were not provided.   On an unknown date, the patient received 0.7 mL dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UT7715BA) via unknown route in the right arm for prophylactic vaccination.  On an unknown date, the patient developed non-serious events of having problems with his nipples where he pushes them down and they get sore (nipple pain), stomach was upset (abdominal discomfort), didn't feel like he wanted to eat (decreased appetite), could have hit a nerve in his chest and ribs (vaccination site nerve damage), nauseous (nausea) and tired (fatigue) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  It was reported, 3 weeks ago he received the Fluzone HD QIV and he states that he has been sick for 3 weeks now. He states that he is having problems with his nipples where he pushes them down and they get sore. He states that he went to his doctor and his doctor told him that it could be caused by the flu shot that he got. He states that he has been getting the same flu shot for 8-9 years and he never had a problem before. He states that he was also nauseous, and his stomach was upset, and he didn't feel like he wanted to eat, and he was tired. He states that his doctor told him that everything he had seemed like the flu shot could have caused it and that it could have hit a nerve in his chest and ribs and that is why he is having trouble with his nipples. He states that it is a sharp pain when he pushes on them. He states that he "believes in the shot" and he "never got a cold from it", and it has always been good for him when he gets it in September or October.   Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was Not Recovered / Not Resolved for all the events.
pt recv vax & devel dizziness & nausea;initially dx of a viral infect in the inner ear was made;later dx of Meniere's synd was made;
The first 3 days my arm was sore. On the 4th day I started getting itching, my eyes were watering and itching, my head and hair was itching, my face was itching, my skin was itching. I had a runny nose. I had headaches, sever chills, nausea and sweating. That lasted for 6 full days.  I did call my doctor's office and talked to the nurse, she found an urgent care center close to my home, and told me if I felt like I needed to go that would be the place to go.
stomach issues; Buzz in her ear; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of TINNITUS (Buzz in her ear) and ABDOMINAL DISCOMFORT (stomach issues) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Feb-2021, the patient experienced TINNITUS (Buzz in her ear). On an unknown date, the patient experienced ABDOMINAL DISCOMFORT (stomach issues). At the time of the report, TINNITUS (Buzz in her ear) and ABDOMINAL DISCOMFORT (stomach issues) had not resolved.            Concomitant medications were not reported Patient visited a doctor but was told there was nothing wrong with the ear. No medication was prescribed or taken for it. The event only started after she had the vaccine.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: New event added, confirmed that event is still ongoing.
minor swelling of my lips, hands, feet; minor swelling of my lips, hands, feet; extreme fatigue; a feeling of tightness and some difficulty swallowing in my throat; a feeling of tightness and some difficulty swallowing in my throat; This is a spontaneous report from a contactable consumer (patient). A 34-year-old non-preganant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration, administered in left arm at the age of 34-year-old on 15May2021 16:30 (Batch/Lot Number: EW0185) as single dose for covid-19 immunisation. Medical history included seasonal allergies, asthma, gastrooesophageal reflux disease(GERD). Concomitant medications included spironolactone; fexofenadine hydrochloride (ALLEGRA); mometasone furoate (FLONASE); omeprazole magnesium (PRILOSEC), all the medications received from 2021 (within 2 weeks of vaccination). The patient previously took sulfa and doxycycline. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in left arm at the age of 34-year-old on 17Apr2021 18:00 (Batch/Lot Number: EW0164) as single dose for covid-19 immunisation. The patient woke up the next day with minor swelling of her lips, hands, feet, and a feeling of tightness and some difficulty swallowing in her throat. The swelling receded with a non drowsy antihistamine but the feeling of extreme fatigue and a histamine reaction continued. No treatment received for events a feeling of tightness and some difficulty swallowing in her throat. The start date of all events was on 16May2021 08:00 and no hospitalization prolonged. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The outcome of the events was recovering.
LEFT ELBOW HURTS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the subject experienced left elbow hurts. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from left elbow hurts. This report was non-serious.
?Covid arm? mild swelling for a few days and occasion, mild itchiness at the injection site
This spontaneous report as received from a nurse practitioner refers to an unspecified number of patients. On unknown dates the patients were vaccinated with doses of ROTATEQ, injection, (lot #, expiration date and dose unspecified) that were exposed to 8.5 degree centigrade to 12 degree centigrade for 158.5 hours which was an excursion that was not supported by in-house stability data. No adverse effect reported. This is one of several reports from same source. Additional information has been requested.
!st dose 1/26/21; 2nd dose 2/23/21: Felts general malaise for 3 weeks after each shot.Then on 3/23/21 (4 weeks after 2nd dose developed a UTI that has now become a recurrent UTI (5 times in 12 months). I never had any UTI issues in decades then this occurred. I did have the Booster on 10/23/21 but am nervous about the new booster I need now since concern it may trigger another UTI episode. Seen by GP, urologist and gynecologist to determine why this is now occurring.
Next days got a outbreak of shingles in mouth . treatment I used was salt water for five days and the outcome was that the shingles outbreak decreased and went away.
This spontaneous report as received from a nurse via a company representative refers to a 1 year old male patient. At the time of vaccination, the patient had runny nose. On 19-AUG-2016, the patient was vaccinated with M-M-R II subcutaneously (dose, lot # and expiration date were not reported). In approximately August 2016, reported as within 5 days after vaccination, the patient was covered from head all the way down with a like measles rash. The patient was also running a fever of "102" and a runny nose. The reporter believed that it was not measles it was just the way the patient responded to vaccine. No treatment was given for the adverse events. No lab diagnostic studies were performed. The patient sought medical attention (unspecified). The outcome of the events was reported as recovering. The relatedness between the events and M-M-R II was not reported. Additional information has been requested.
On 6/15/09 she notified us that she last seen her family doctor due to inflammation. At site temp 100 and headache diarrhea, upset stomach. She shared that she forgot that as a child she had a severe reaction after a Pertussis vaccine Tx with ZYRTEC, BENADRYL
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the parent. A 8 year-old male patient received bnt162b2 (BNT162B2), administration date Feb2022 (Batch/Lot number: unknown) as dose 2, single for Covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, Single), for Covid-19 immunization. The following information was reported: SEIZURE (medically significant) with onset 17Feb2022, outcome "recovered" (17Feb2022), described as "Had a seizure without a fever; 20 hours after the second dose". Therapeutic measures were not taken as a result of seizure. Clinical course: As reported the patient had no adverse effect since 17Feb. The lot number for bnt162b2 was not provided and will be requested during follow up.