chrisvoncsefalvay/vaers-outcomes huggingface dataset:
rash; redness; hives; This is a spontaneous report from a contactable consumer or other non hcp. A 60-years-old female patient (age at the time of vaccination was 60yrs) received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EN6199), dose 1 via an unspecified route of administration, administered in Arm Left on 06Mar2021 10:30 as DOSE 1, SINGLE for covid-19 immunisation. Medical history included chronic obstructive pulmonary disease from an unknown date and unknown if ongoing Verbatim: COPD, depression from an unknown date and unknown if ongoing Verbatim: Depression , anxiety from an unknown date and unknown if ongoing Verbatim: Anxiety , seasonal allergy from an unknown date and unknown if ongoing Verbatim: allergic to ragweed , seasonal allergy from an unknown date and unknown if ongoing Verbatim: pollen in the air , mycotic allergy from an unknown date and unknown if ongoing Verbatim: mold, hypothyroidism from an unknown date and unknown if ongoing, insomnia from an unknown date and unknown if ongoing, hypersensitivity from an unknown date and unknown if ongoing. Concomitant medications included levothyroxine sodium (SYNTHROID) taken for hypothyroidism from an unspecified start date and ongoing; bupropion hydrochloride (WELLBUTRIN) taken for depression from 2014 and ongoing; buspirone (BUSPIRONE) taken for anxiety from 2014 and ongoing; methylphenidate hydrochloride (RITALIN) taken for depression from 2018 to an unspecified stop date; trazodone (TRAZODONE) taken for insomnia from 2016 and ongoing; formoterol fumarate, mometasone furoate (DULERA) taken for chronic obstructive pulmonary disease from an unspecified start date and ongoing; fluticasone propionate (FLONASE ALLERGY RELIEF) taken for hypersensitivity, start and stop date were not reported; cyanocobalamin (VITAMIN B12 [CYANOCOBALAMIN]) taken for an unspecified indication from Mar2021 to an unspecified stop date. On 10Mar, patient broke out in a rash, and it developed inside and behind her legs, her knees, arms, and stomach. She said there was a lot of redness, and little bumps. She said it felt like hives. Consumer said she already went to the doctor and was told that it could have been a large local delayed reaction to the 1st dose. Then on 22Mar, since the rash was not going away, she was put on Prednisone. She wants to know if the rash is associated with the vaccine, and if it would still be safe for her to receive the second dose of the covid vaccine was scheduled for Saturday, 27Mar2021. On 10Mar2021 the patient experienced rash, redness and hives. Therapeutic measures were taken as a result of the events. The outcome for the event rash was recovering while for others it was unknown. No follow-up attempts are possible. No further information is expected.   Follow-up (24Mar2021): This is a Follow-up spontaneous report from a contactable consumer. This consumer (Patient) reported that:  Patient characteristics: Age at time of onset of reaction/event: 60
Her conditions (leg swelling, coughing) get deteriorated after the vaccination. She was found pericardial effusions and plural effusions 2 weeks after the second dose. She stayed in ICU for 6 weeks and passed away.
Case number PHEH2044US003853 is an initial spontaneous report received from a pharmacist on 21 FEB 2014 with a follow up report received from the pharmacist on 21 MAR 2014. This report refers to a 15 year old female patient. Her past vaccination history included seasonal influenza with was well tolerated. She was inadvertently vaccinated with FLUCELVAX (batch number: 01003A and expiry date: JUN 2014) intramuscularly into her left arm at a dose of 0.5 ml on 02 JAN 2014 at 15:57 hours. No adverse event was reported following this administration error (inappropriate age at vaccine administration).   Follow up report was received from the pharmacist on 21 MAR 2014. The anatomical site of vaccination, vaccination history, time of vaccination and the reporter's details were updated.  Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 21 MAR 2014. The BPI labeling of the event "inappropriate age at vaccine administration" changed from listed to unlisted and added second indication as "drug used in unapproved population".
Tdap - local red area right deltoid and blotchy also nausea, fever.
After the last set of immunizatoins his equilibruim was off for about 10 days. It seemed that he was really tired all day and kept falling.  For about  5-6 days after getting last set of shots, when Pt was falling asleep at night, Pt would shake all over for less than 15 seconds and then fall asleep. He has not done it since. He had a little bit of a fever for 3 days after the last set of shots. Otherwise he has been fine. He is eating a variety of foods. He is talking, climbing, playing... he is having no neuro symptoms now.
stroke; blocked artery in his neck to the brain; his artery is totally blocked; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (Unknown).  A male patient received BNT162b2 (BNT162B2), as dose 1, 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: CEREBROVASCULAR ACCIDENT (medically significant), outcome "unknown", described as "stroke"; CAROTID ARTERY DISEASE (medically significant), outcome "unknown", described as "blocked artery in his neck to the brain"; ARTERIOSCLEROSIS (non-serious), outcome "unknown", described as "his artery is totally blocked".  Clinical course: Reporter mentioned that she and her husband already got the 3 shots of Pfizer COVID-19 Vaccine and she mentioned that her husband experienced a stroke, and they want to know the if the Pfizer shot instigated some of it and they are calling to ask, what was the legal status on this. If the vaccine instigated this situation and must find out what was the legal status. She also mentioned that they have 3 authorities in their family and there was so much to get into the legal history right now. So, they are just reporting this stroke that her husband experienced, and also mentioned that he got block, his artery is totally blocked, blocked artery in his neck to the brain that was why he experienced stroke." Appropriate response could not be provided as the Reporter hung up the call abruptly. Call back was done; however, reporter did not respond over the call. Thus, further probing could not be done  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300024699 same patient/drug/AE, different dose;US-PFIZER INC-202300024827 same patient/drug/AE, different dose;
Pt called the pharmacy on 10/12/10 to report a possible reaction to the vaccine. She received the vaccine on 10/9/10 and she reported on 10/10/10 night she noted a rash on her chest, hips, stomach and back.
2 days p/vax pt noted throat scratchy;2 days later fever 101 to 103 lasting for 5 days;also noted coughing & aching;stayed in for 7 days;
Medical assistant reported a 19 year old patient received two doses of pediatric VAQTA.; Medical assistant reported a 19 year old patient received two doses of pediatric VAQTA.; no additional AE; This spontaneous report was received from a medical assistant and refers to a 19-year-old patient of unknown gender. No information regarding patient's pertinent medical history, drug reactions, allergies and concomitant medications was reported.  On an unknown date, the patient was vaccinated with a pediatric dose of hepatitis a vaccine, inactivated (VAQTA) for prophylaxis (exact dose, route, anatomical location, lot # and expiration date were not reported). On an unknown date, the patient received the second pediatric dose of hepatitis a vaccine, inactivated (VAQTA) lot # 1971534, expiration date 06-OCT-2024 (product administered to patient of inappropriate age, incorrect dose administered) (exact dose, route and anatomical location were not reported). No additional adverse events reported.
Information has been received from a 75 year old female consumer with heart disease, cholesterol, blood pressure and breast cancer and with no drug reactions or allergies who on 30-SEP-2010 was vaccinated with ZOSTAVAX (Merck) (lot # unknown). Concomitant therapy included CRESTOR, BENICAR, anastrozole, baby aspirin and GABAPEN. The patient had a history of pain and increased high blood pressure while on prior therapy with rofecoxib (MSD, WAES 1010USA02491). The consumer mentioned that on 04-OCT-2010 she had a mild case of shingles. The consumer went to their health care professionals and they diagnosed it as shingles. No laboratory diagnostics studies were performed. At the time of report, the patient's outcome was unknown. No laboratory tests were performed. It was reported that an unspecified treatment was given. No further information is available.
Generalized myasthenia gravis; This spontaneous case was reported by a consumer and describes the occurrence of MYASTHENIA GRAVIS (Generalized myasthenia gravis) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     Concurrent medical conditions included Ocular myasthenia (Prior getting Moderna COVID-19 vaccine, just about finishing treatment for Ocular Myasthenia.).    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, the patient experienced MYASTHENIA GRAVIS (Generalized myasthenia gravis) (seriousness criteria hospitalization and medically significant). At the time of the report, MYASTHENIA GRAVIS (Generalized myasthenia gravis) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  The patient had got monthly infusion treatment of IVIG.  The patient doctor said they did not had an idea if her symptoms were related to the vaccine. The patient symptoms had worsened. Patient had not ever tested COVID positive test or had COVID-19 diagnosis. No other vaccination were given within 1 month prior to Moderna COVID-19 vaccine.  Company Comment: This is a Spontaneous case concerning a 74-year-old female patient, with medical history of ocular myasthenia, who experienced the unexpected, serious (hospitalization and medically significant), and AESI of Myasthenia gravis. The event started approximately 3 weeks after the first dose of mRNA-1273 vaccine, and was exacerbated after second and third dose. She gets monthly infusion of immunoglobulin IV. Medical history of ocular myasthenia remains confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-529242 (Patient Link).; Sender's Comments: This is a Spontaneous case concerning a 74-year-old female patient, with medical history of ocular myasthenia, who experienced the unexpected, serious (hospitalization and medically significant), and AESI of Myasthenia gravis. The event started approximately 3 weeks after the first dose of mRNA-1273 vaccine, and was exacerbated after second and third dose. She gets monthly infusion of immunoglobulin IV. Medical history of ocular myasthenia remains confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
FACIAL REDNESS, FACIAL SWELLING, FINE RED FACIAL PAPULES AND FINE RED UPPER EXTREMITY PAPULES WITHIN 5 MINUTES OF ADMINISTERING MMR, Dtap and IPV IMMUNIZATIONS.
BLURRY EYE; DIZZY; PAIN IN HEAD; NAUSEA; VOMITING; BURNING UP; NERVE PAIN; ABOUT TO PASS OUT; PINS STICKING IN HER EYES; BLOOD/TISSUE IN URINE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included covid 19, and concurrent conditions included copd, neuropathy in feet, diabetes, and heart problem.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, expiry: 25-MAY-2021) dose was not reported, administered on 08-MAR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced blood/tissue in urine. Laboratory data included: Urine analysis (NR: not provided) Blood/tissue in urine. On 09-MAR-2021, the subject experienced vomiting. On 09-MAR-2021, the subject experienced burning up. On 09-MAR-2021, the subject experienced nerve pain. On 09-MAR-2021, the subject experienced about to pass out. On 09-MAR-2021, the subject experienced pins sticking in her eyes. On 09-MAR-2021, the subject experienced dizzy. On 09-MAR-2021, the subject experienced pain in head. On 09-MAR-2021, the subject experienced nausea. On 11-MAR-2021, the subject experienced blurry eye. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from nausea, vomiting, pain in head, blurry eye, burning up, about to pass out, and blood/tissue in urine, and the outcome of nerve pain, pins sticking in her eyes and dizzy was not reported. This report was non-serious.  Version created to amend previously reported information on 11-Mar-2021. Upon review, the following information was amended: Medical history hear problem updated to heart problem.; Sender's Comments: V0 Medical assessment comment not required as per standard operating procedure as the case assessed as non-serious.
pt recv vax 20MAY97 & 21MAY97 parent called stating pt had a purple discoloration of skin from inj site extending up to hip across buttock;on observation by RN area looked mottled;
I developed a 3-4 inch diameter red, swollen, painful, and warm area just below the injection site on my left arm, the day following my second dose of the Covid vaccine. I reported it to  today and they have proceeded to treat the reactions as a possible case of cellulitis and they have placed me on dicloxacillin 500mg four times a day for 7 days. I?ve been using an ice pack to cool the area and help with the pain as well as alternating between ibuprofen and Tylenol for pain.
Pt had an initially small red mark when the Varicella vaccine had been given. Gradually over a 1 week time period, the site expanded to the size of a nickel, not hot but tender. Slightly raised, non-pruritic, not crusted.
Fever about 1 month after receiving first dose; This spontaneous case was reported by a physician and describes the occurrence of PYREXIA (Fever about 1 month after receiving first dose) in a 1-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In June 2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jul-2022, the patient experienced PYREXIA (Fever about 1 month after receiving first dose). At the time of the report, PYREXIA (Fever about 1 month after receiving first dose) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported. It was reported that patient received 1 dose of vaccine 1 month ago, she was due for 2nd dose on 27-jul-2022. No treatment drug details was reported.   Reporter did not allow further contact
swelling in left arm; itching in left arm; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 04-Mar-2021 and was forwarded to Moderna on 05-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (swelling in left arm) and VACCINATION SITE PRURITUS (itching in left arm) in a 58-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure and Thyroid disorder. Concomitant products included METFORMIN for an unknown indication.    On 28-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 SWELLING (swelling in left arm) and VACCINATION SITE PRURITUS (itching in left arm). At the time of the report, VACCINATION SITE SWELLING (swelling in left arm) and VACCINATION SITE PRURITUS (itching in left arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient was taking unspecified medications for blood pressure and thyroid.
Pt reports headache, chest pressure, eye pressure, diaphoresis and rash. Pt has a red flat rash on chest and upper back
Gave inj in (L) Deltoid. Pt/Mom left office approximately 10 mins after inj. Front desk employee came back stating Pt. fainted in elevator. She was given water and PEDIALYTE. Physician stayed with pt/Mom until she was feeling better. BP checked. Also, Pt. hadn't eaten since 10:00a that day.
5H after administration patient with swelling hands, feet, mouth and felt her throat closing difficulty breathing. Went to ER started nebulizer, given steroids, antihistamine.
Shortly after end of visit returned to clinic with swollen red painful left eye(lids); not itchy; no rash; no shortness of breath; no swelling of lips, tongue, or extremities.   L/S CTAB.   Benadryl 50mg PO x1 administered in clinic.  Swelling began to improve within 1/2 hour.  Added cetirizine the following day due to incomplete resolution of sx.
I started getting symptoms of sore throat, runny nose, but no fever. My symptoms were mild but then my wife tested positive. I took an at home COVID-19 test that was positive. I contacted a health department and had antibodies infusion. I feel like that did help the symptoms.
Received the H1N1 vaccine on 12/23/2009 in the evening, began to feel a "surge" right away, he states that a surge is when he feels weak and the room "seems to fade away". He was walked out to the lobby to sit down, his blood pressure was taken and his temperature was taken. He was told he had a slight fever but no number was given to him. His temperature  was not taken  prior to receiving the vaccine. He was told to go home but he drove around his town for a few hours. He states he is allergic to thimerasol, SSRIS, he received teramycin as a child and vomited. He mentioned that he has felt a "surge feeling" after the past two seasonal flu shots but the effects went away quickly, this time after the H1N1 vaccine it lasted for 3 hours. He received the seasonal flu vaccine in September. The man stated he did not see his doctor for the surge feeling nor did he call him.
I woke up with severe vertigo & nausea on Sunday, May 2nd. Continued to experience severe vertigo until Wednesday, May 5th. I had trouble walking, moving my head & eyes to the side or vertically, and couldn't tolerate bright lights or loud sounds. Vertigo symptoms mainly subsided on Wednesday evening, but I have been experiencing other symptoms since then. I have felt very "off" as if I'm floating, or high on drugs (I have not taken any medication for this). I've experienced a headache and felt lightheaded, and dizzy if I make certain head movements. I have never experienced anything like this before. I've had vertigo once before this, but it only lasted several hours and I did not experience any other symptoms. I also experienced slight vertigo (only a couple of seconds) as the first symptom of COVID when I had it in March 2020.
Patient stated her arm hurt so bad that she was unable to move it, felt chills and achy all over, fatigued. After 24 hours symptoms began to resolve. Headache initially much better, today.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 39-year-old male patient received BNT162b2 (BNT162B2), on 28Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 38 years for Covid-19 immunisation; CoviD-19 vaccine mRNA (mRNA 1273) (MODERNA COVID-19 VACCINE), on 12Jul2022 as dose 4 (booster), single (Batch/Lot number: unknown) for Covid-19 immunisation; CoviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for Covid-19 immunisation. The patient's relevant medical history included: "type 2 diabetes" (unspecified if ongoing). Concomitant medication(s) included: FISH OIL; FLONASE [FLUTICASONE PROPIONATE]; VITAMIN D [VITAMIN D NOS]; VITAMIN C [ASCORBIC ACID]; PROBIOTICS. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: On unknown date patient was tested positive and took Paxlovid treatment; (17Jul2022) Negative; (19Jul2022) Negative; (22Jul2022) Negative; (28Jul2022) Positive. Therapeutic measures were taken as a result of drug ineffective, Covid-19. Additional information: Product=COVID 19 Treatment, Paxlovid, start date=12Jul2022, stop date=17Jul2022. Other medication in 2 weeks product=Fish Oil, Flonase, Vitamin D, Vitamin C and Probiotics. Adverse event: Tested negative after Paxlovid treatment on 17Jul, full recovered and tested negative again on 19Jul and 22Jul. Symptoms came back and tested positive on 28Jul. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Vaccine given on the afternoon of February 23, 2022 via intramuscular route in right deltoid. Waited 15 minutes with no immediate reaction or soreness. Arm soreness developed later that evening.   On February 24, 2022, right arm became red and increasingly sore. Co-workers were able to visibly notice the area. That evening (24 hours after vaccine received), her arm became extremely sore, as well as  experiencing body aches, chills and fatigue. The injection site arm  became raised at this time. She was unable to lift arm above shoulder height without extreme pain. Took Tylenol Cold & Flu to help with aches and chills.   On the morning of February 25, 2022, she can lift her arm somewhat better but is still very sore. She took four Advil 200 mg (800 mg total) and it helped some. Presently, arm is still very tender, sore, red, and raised. Area feels almost like a knot in the muscle.
Small amount of of soreness after shot and that evening she noted some tenderness and maybe pale colored skin in the area of the injection.  However, there was no warmth swelling or redness.  The next morning she noted the area had increased in size slightly and was red warm and tender to touch.  Later on that day she noted the area enlarged and was now red.  It remained warm to touch, mildly tender and raised.  There is no itching.  The areas well defined.  There is no streaking.  The areas continue to slowly advanced to its current position.  She has not had any fever myalgias arthralgias.  No wheezing shortness or breath or headaches.  Her appetite has been good.  There is no pain or soreness in other areas outside of this reaction site.  There has been no skin trauma to the area.  She had a very similar though less intense reaction after she got her 2nd shingles vaccine though it is less red tender and warm, and is not as extensive.  The patient ultimately treated this with a course of antibiotics and resolved.  She has no previous history of reaction to influenza or Pneumovax vaccine.  She has no history of egg allergy.