chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The patient received first dose at 10 years & 8 months and the second dose at 14 years & 3 months with no AE.; Initial information regarding an unsolicited valid non-serious case was received from other healthcare professional via Agency (Reference number- 00631041) and transmitted to Sanofi on 07-Jun-2021.  This case involves a 16 years old female patient who received first dose at 10 years and 8 months and the second dose at 14 years and 3 months of  suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot number and expiration date were not reported) via unknown route at an unknown administration site for prophylactic vaccination (inappropriate schedule of product administration) on an unknown date.  The patient's medical history, past medical treatments, past vaccinations, concomitant medication and family history were not provided.   The reporter stated that patient is currently 16 years old and asked does patient need a booster?  It was an actual medication error case due to inappropriate schedule of vaccine administered (latency: same day).  At the time of reporting, the patient experienced no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information on the batch number for this case.
Had a really bad headache and experienced extreme chills few hours after my vaccination. I have never experienced something like this, so I went to the doctors' clinic for assessment. When I arrived at the clinic, they checked my blood pressure and my temperature and it was 101, so it was bit concerning for me and my blood pressure was 140/100 which was not normal for me. They decided to do an IV medication for me and had me rest there for 3 hours. I fell asleep during those 3 hours then when I woke up, I felt so much better. They checked my blood pressure, and it was back to normal, and my temperature was 97.
2cm in diameter redness and swelling with left over mild scarring of the skin at 1 month out. No skin breakdown or necrosis. Redness followed by mild hyperpigmentation with overlying rough texture.
Pt states she developed numbness in feet and perineum on 3/26/03, subsequently got paresthesias on trunk 3/28/03 and hands, no symptoms of muscle weakness or pain, no problems with walking, talking or eating or shortness of breath.
Arm redness; Feels likes someone has punched me in the arm; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Arm redness) and PAIN IN EXTREMITY (Feels likes someone has punched me in the arm) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, the patient experienced ERYTHEMA (Arm redness) and PAIN IN EXTREMITY (Feels likes someone has punched me in the arm). At the time of the report, ERYTHEMA (Arm redness) and PAIN IN EXTREMITY (Feels likes someone has punched me in the arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. Treatment medications were unknown.  The patient reported that it felt warm when the vaccine went in.
virus x 2; virus x 2; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: (RA). The reporter is the patient.  An elderly female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, 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 "not recovered" and all described as "virus x 2".  Clinical course: The reporter considers event as caused by suspect product(s). I don't believe any vaccine is 100%. Had them and still got virus x 2. CSP Name: COVID-19 Patient Community for 2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Covid vaccine, felt dizzy with palpitations 5 minutes after.  Elevated bp 150s systolic.   No past medical history no surgical history.
RAISED AROUND THE INJECTION; WARM TO TOUCH AROUND THE INJECTION; HURTS TO LIFT LEFT ARM; LEFT ARM SORENESS; REDNESS AT THE INJECTION SITE; This spontaneous report received from a patient concerned a 63 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included hypothyroidism, high cholesterol, outside weeds allergy, eczema, and hives.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 203A21A expiry: 19-JUL-2021) dose was not reported, administered on 08-APR-2021 16:00 for prophylactic vaccination. Concomitant medications included acetylsalicylic acid for thrombolytic event. On 28-DEC-2020, Laboratory data included: Coronavirus test (NR: not provided) Positive. On 08-APR-2021, the subject experienced raised around the injection. On 08-APR-2021, the subject experienced warm to touch around the injection. On 08-APR-2021, the subject experienced hurts to lift left arm. On 08-APR-2021, the subject experienced left arm soreness. On 08-APR-2021, the subject experienced redness at the injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from redness at the injection site, raised around the injection, warm to touch around the injection, left arm soreness, and hurts to lift left arm. This report was non-serious.
Approx. 20 minutes following the vaccination, pt  began experiencing hives across both shoulders and neck.  Hives were red and "itchy."  Pt began experiencing swelling of the tongue and eventually of the lips as well.  Treatment was administered by ER.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results. Therapeutic measures were taken as a result of drug ineffective, covid-19 with paxlovid from 13Jun2022 to 18Jun2022.  Clinical Course: Reported as, Felt fine after day 4 of the treatment, and then on day 3 after patient ended the treatment patient developed congestion, runny nose, and headache with occasional sneezes.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
After MENACTRA, TDAP, vaccination, HEP A given 2min, Pt looked dazed, then arched neck and body, hands and arms curled in.
Sore throat, Feverish, Symptoms similar to Cold and flu symptoms, Occassional cough, Vaccine site has Baseball size lump with itching. No treatment given.
dose given only one month after 2nd dose of Pfizer vaccine.  Given too soon.
Pt received flu shot on 20 Dec 05 that evening left arm had a large welt became hot and itching. On 22 Dec 05 pt was seen by Dr friend and diagnosed with an allergic reaction.
Nausea/vomiting, swelling of the face, rash cheek bones.
Tetanus Diptheria given 07/07/2005 on 07/09/2005, she noticed tender area, raised over left clavicle.  Tetanus Diptheria give to left deltoid.
About 1 hour after vaccine tingling tongue & hand (R), poor speech/articulation, headache.
Itching on the same arm the vaccine was given, with most severe itching along web of fingers and top of hand.
3 hours after receiving the vaccine, coworker found patient hunched over in his stool. Patient appeared pale and very weak, still verbal but unable to understand responses
Hives (full body) including scalp,  difficulty breathing, runny nose sneezing, diarrhea, GI irritation  continuous hives. Today is 07/06/23 and worse by the day.
Chills, aches, sore throat, fever, extremely tired, sleepy, no appetite, cough (2nd line lasted 5 1/2 weeks)! BENADRYL, acetaminophen, naproxen.
4 year old child inadvertently received Pentacel instead of Quadracel/no AE; Initial information received on 21-May-2020 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 4 years old patient who inadvertently received DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] instead of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL](batch number and expiry date not reported) via unknown route in unknown administration site on an unknown date for prophylactic vaccination(wrong product administered). It was also reported that this is the child's 4th dose of DTaP and IPV and an extra dose of HIB.  Past vaccination(s) included tetanus. Medical history, concomitant therapy, medical treatment(s) and family history were not provided.   It was an actual medication error case due to wrong vaccine administered.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on batch number for this case.
This spontaneous report was received from an 85 year old female consumer referring on herself. On 2013, a few months ago she was vaccinated with ZOSTAVAX, (lot number not reported). On an unknown date, she got a case of the shingles on her left arm, shoulder, left part of her back. The shingles came and went after a few weeks but still suffers with nerve pain, still present. The patient sought medical attention and was treated with patches. The outcome of she got a case of the shingles on her left arm, shoulder, left part of her back was reported as not recovered/not resolved. Additional information is not expected.
This spontaneous report was received from a female patient of unknown age who was referring to herself. There was no information regarding the patient's medical history, concomitant medications, drug reactions or allergies provided. On an unknown date, the patient was vaccinated with ZOSTAVAX in injection for prophylaxis (dose, lot number and expiration date were not provided). On an unknown date, the patient experienced reaction at the injection site. The outcome of the event was unknown. The relatedness between the event and ZOSTAVAX was not reported.
112408 - Pt c/o pain in feet; 112508 pain cont, now can't pick up objects with hands; 112608 requires assist to walk into ER; 112708 is now bedbound. Test, plasmapheresis - anemia - RBC given - rehab  7/7/09 MR received for DOS 12/20/2008-01/08/2009 with D/C DX:  Guillain_Barre Syndrome, axonal type.  HTN.  DM.  Mild tachycardia.  Pt presented with progressive weakness in LEs, then hands. PE (+) for decreased strength and sensation. Absent reflexes. Pt c/o severe pain and muscle spasm of lower extremities, 1-2+ LE edema. DVTs noted in LEs tx with anticoagulants. Plasmapheresis with little improvement. One dose of IVIG with some improvement.  Transferred for rehab on 1/8/09.    ICD9:  V5783.  3570. 4019.  /
Severe aching in right arm, especially in forearm and inside arm area at elbow. Took ADVIL (400mg) with little relief after 60 min. Pain radiates throughout mid to lower arm (right arm).
Injection site was itchy and a raised lump appeared at the injection site.  The skin around the site was warm to the touch and slightly red.
Pt vaccinated with Influenza/TD developed intense pain & inability to move. MD prescribed antibiotics Cephalexin. Few days later still no improvement. MD removed blood clot & pt instantly regained ROM.
HEADACHES; MUSCLE ACHES/PAINS; VACCINE EXPELLED ON THE BODY INSTEAD OF GOING INTO THE ARM; NEEDLE WAS NOT SCREWED TO SYRINGE; LETHARGIC; SORENESS AND INSIDE PAIN; ARM PAIN; ARM SWELLING; 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 concurrent conditions included factor 5 leiden, environmental allergy, food allergy, and pain killers allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: UNKNOWN) dose was not reported, administered on 03-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the subject experienced arm swelling. On APR-2021, the subject experienced arm pain. On 03-APR-2021, the subject experienced vaccine expelled on the body instead of going into the arm. On 03-APR-2021, the subject experienced needle was not screwed to syringe. On 03-APR-2021, the subject experienced lethargic. On 03-APR-2021, the subject experienced soreness and inside pain. On 03-APR-2021, the subject experienced muscle aches/pains. On 04-APR-2021, the subject experienced headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lethargic, soreness and inside pain, and muscle aches/pains on 04-APR-2021, had not recovered from headaches, arm pain, and arm swelling, and the outcome of vaccine expelled on the body instead of going into the arm and needle was not screwed to syringe was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment was not required as per standard operating procedure as the case assessed as non-serious
In early September 2007, patient began to experience unexplained weight loss, increased thirst and frequent urination.  He was diagnosed with diabetes at a local hospital on 09/21/2007; diagnosis of Type 1 based on positive GAD antibodies obtained on 9/27/2007.
Information was received on 24-JUL-2017 from a lawyer regarding a case in litigation concerning a male patient of unknown age. It was reported that the patient was inoculated with a dose of ZOSTAVAX on about 11-MAY-2007 at a physician's office as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended but rather caused the patient to contract a persistent strain of herpes zoster. On or about 06-JAN-2013, the patient was treated in the emergency department for a painful and blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles, spreading to his genitals and causing nerve pain. The patient was prescribed famciclovir (manufacturer unknown) for management of his excruciating outbreak. As a direct an proximate result of these malfunctions, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering and other damages. Additional information has been requested.
Information has been received from a pharmacist concerning her Husband, who In "November or December 2012" had received ZOSTAVAX 0.65 ml subcutaneously. He developed a red raised area at the injection site that lasted about 5-7 days and resolved in "November or December of 2012". It was unspecified if patient received treatment. The patient did not sought medical attention. The pharmacist had also received ZOSTAVAX at the same time and experienced a similar AE (captured in Case # 1301USA002198). Additional information is not expected.
Superficial Thrombus in the left leg; This is a spontaneous report from a contactable Nurse (patient herself). A 30-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in Arm Left on 29Jul2021 16:00 as dose 1, single for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Medical history was not reported. Concomitant medications included drospirenone, ethinylestradiol (LORYNA) taken for contraception, start and stop date were not reported. Other medications the patient received within 2 weeks of vaccination are Loryna Birth Control. Patient did not diagnose with COVID-19 prior or since the vaccination. There were no known allergies were reported. On 09Aug2021 the patient experienced superficial thrombus in the left leg. The adverse event resulted in emergency room/department or urgent care. No treatment was received for adverse event. Seriousness criteria-resulting in death, life threatening, caused/prolonged hospitalization, disabling/Incapacitating and congenital anomaly/birth defect reported as no. The outcome of the event was recovering on an unspecified date.  Information about lot/batch number has been requested.
Pt states she felt short of breath, had a hard time catching her breath, and fatigued.
Pain at injection site began at time of injection and continued.  Joint pain, especially knees, began about 6:30 p.m. (two hours after injection).  Flu type symptoms (all over body aches) began at 10:00 P.M.  Headach and chills began at 12:00 A.M. and temperature was 100.6.   Chills, shaking, and fever worsened, headache became severe, and temperature was 102.8 at 4:00 A.M.  Tuesday, March 9th.  Headache, body aches, and temperature varying between 100.0 - 101.3 , and continued through Wednesday night, March 10th.  Wednesday afternoon, elevated heart rate and tinnitus were first noticed and fatigue continued.   Checked watch and average heart rate had increased 10 beats per minute.  First normal temperature of 98.6 was taken Thursday, March 11th at 8:00 A.M.  On Thursday, eyes became noticeably red and face and upper chest area skin reddened (e.g. like sun exposure without sunscreen).  Tinnitus continued and was very loud even with background noise.  Loud tinnitus and overall fatigue continues today, Monday March 16th.
Patients father who signed the consent form stating a DOB 04/23/2004.  The patient said he was 16.  When giving the second dose they put a DOB of 04/23/2006 .  The first shot was given before Pfizer was approved for 12-15 year olds.  I verified with the father the correct DOB of 4/23/2006.  He received his second shot 5/21/2021
Rheumatoid arthritis flare up; Fatigue; Stress; Pain in arm/sore arm;   This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient.  A 62 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation; adalimumab (HUMIRA) (Batch/Lot number: unknown) at citrate free for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RHEUMATOID ARTHRITIS (medically significant), outcome "recovered", described as "Rheumatoid arthritis flare up"; FATIGUE (non-serious), outcome "unknown", described as "Fatigue"; STRESS (non-serious), outcome "unknown", described as "Stress"; PAIN IN EXTREMITY (non-serious), outcome "recovering", described as "Pain in arm/sore arm". The action taken for adalimumab was unknown.  Causality for Humira (Adalimumab) The reporter's causality for the event(s) of fatigue was not provided. The reporter's causality for the event(s) of Rheumatoid Arthritis flare and pain in arm/sore arm and stressed with Humira (Adalimumab) was no reasonable possibility. Causality for Pfizer biontech covid-19 vaccine(Tozinameran) The reporter's causality for the event(s) of Fatigue and pain in arm/sore arm was possible, Stress and Rheumatoid arthritis flare up was not reported.  Clinical course: Pfizer biontech covid-19 vaccine (Tozinameran) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. She received COVID-19 Vaccine manufactured by Pfizer, Biontech.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on limited information, there is reasonable possibility of causal association between the events PAIN IN EXTREMITY, Fatigue, Stress, Rheumatoid arthritis and the suspect drug BNT162B2. 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.
Mom called to clinic on 12/15/17 and reported reaction inside area of quarter to half-dollar size and outside is size of Mom's hand. Patient not seen in clinic. Mom is an LPN.
feeling sweaty; could not sleep; This is a spontaneous report from a contactable consumer (patient) via Medical Information team. A female patient of an unspecified age (Age:79, unit: unknown) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: unknown) dose 1 via an unspecified route of administration on 08Feb2021 as single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. She got the first dose of the Pfizer covid 19 vaccine two days ago on 08Feb2021 and reported feeling sweaty and could not sleep. She wanted to know if she is contagious because she wants to attend a birthday party on Friday 12Feb2021. The outcome of events was unknown.  Follow-up attempts are completed. No further information is expected.
I had a UTI in October then another one in December.  I received antibiotics both times.  I had UTI's  each time I've received a vaccine. Since sept of 2022, I've had one every month. I believe I've had 9 total.  I've also visited a urologist since having these reoccurring  UTI's.
Elevated heart rate (HR got up to 118 bpm). We got her water and had her sit and take some deep breaths. We monitored her HR for 2.5 hours. Over that time it gradually went down, it never spiked back up--118bpm, 97bmp, 96bpm, 90bp, 90bpm, 90bp, 80bpm, 82bpm, 82bpm. (For reference, her resting HR is around 77 per patient)