chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Started with smelly urine which I thought was an odd reaction from the vaccine but it began right after the vaccine for a week or so. Then started getting a strange side ache. Went to my doctor, I had a Bladder Infection ( I am not prone to either UTi,s or bladder infections) I still feel I need to go back to the doctor to follow up;  I don?t feel exactly right. Also definitely body aches that have lingered, lower energy levels and some brain fog. I waited to report because I had convinced myself that these symptoms were not related to the vaccine. But now I think they are. More and more people are reporting similar side effects.
Stiff neck she had had before with the other doses; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Stiff neck she had had before with the other doses) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MUSCULOSKELETAL STIFFNESS (Stiff neck she had had before with the other doses). At the time of the report, MUSCULOSKELETAL STIFFNESS (Stiff neck she had had before with the other doses) outcome was unknown.            No concomitant medications were provided. No treatment medications were reported.    This case was linked to MOD-2021-375282 (Patient Link).
The patient was given a dose of the Zostavax vaccine in the left arm.  At the same time, she received Pneumovax in the same arm, and Fluzone in the other arm.  She experienced severe rash and itching at Zostavax site for seven days, with lump in muscle.  Nine days after administration, she discovered swelling in lymph system on left side of the body from the rib area under the arm up to the neck, above the clavicle.  She experienced fatigue and shortness of breath.  On-call doctor advised a trip to Urgent Care facility on the night of ninth day.  There, X-rays were taken and patient was advised to return the following day.  Upon return another physician requested blood work.  Results of both X-rays and blood work were normal.  The next day, patient saw her family physician, who questioned a possible diagnosis of lymphoma (a possibility, according to the second physician in Urgent Care), and indicated the likely cause was the Shingles vaccine.  At this time, swelling remains, but has subsided to a small degree.
After receiving the vaccine about five minutes later my Chest  became very heavy and painful my throat felt like I?m knot closing and I passed out I was woken up at the site but I was unresponsive all I remember was them telling me to stay awake the ambulance is on the way I became very nauseous
No treatment. Left-arm became numb for a few hours intermittently. It was accompanied by the tightness of the chest on the left side. This went on for two days.
Multiple sclerosis; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38-year-old male patient received BNT162b2 (BNT162B2), on 09Oct2021 as dose 2, single (Lot number: FF2590) at the age of 38 years, in left arm for covid-19 immunisation at Pharmacy or Drug Store. The patient's relevant medical history was not reported. No other vaccine in four weeks. No COVID prior vaccination. Concomitant medication(s) included: DICLOFENAC; OMEPRAZOLE; ZYRTEC [CETIRIZINE HYDROCHLORIDE]. Vaccination history included: BNT162b2 (Dose number=1, Lot number=FE3592, Vaccine location=Left arm), administration date: 18Sep2021, when the patient was 38-year-old, for COVID-19 Immunization, reaction(s): "Tingling of feet then hands and chest". The following information was reported: MULTIPLE SCLEROSIS (disability, medically significant) with onset 29Dec2021, outcome "unknown". The patient underwent the following laboratory tests and procedures: multiple tests: (29Dec2021) Multiple sclerosis; SARS-CoV-2 test: (unspecified date) Negative. Patient was tested for Covid post the vaccination. Therapeutic measures were taken as a result of multiple sclerosis.  Clinical course: Adverse event started with tingling of feet then hands and chest. Soon the chest and feet stopped tingling but the hands never did. Had multiple tests ran and was diagnosed with Multiple sclerosis on 29Dec2021. Other medications in two weeks included pine bark extract.
When shot was given it burned throughout my whole arm. In comparison I didnt even feel my 1st shot. My arm all the way to my fingers continued to hurt and was numb for the next 3 weeks. I felt like someone injected me with acid. In addition the injection site bleed for 5 to 10 mins, this also did not occur when i received the 1st shot. To this day, I believe the vaccine was contaminated.
Patient had severe nausea and dizziness after receiving the vaccine. She went to the emergency room where she was given supportive care including tylenol and ibuprofen. She is feeling much better now.
Medical assistant reports that she gave 10 doses (the whole vial) of IPOL to a patient with no reported adverse event; Initial information received on 24-May-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 16 years old male patient who experienced medical assistant reports that she gave 10 doses (the whole vial) of ipol to a patient with no reported adverse event while receiving vaccine IPV (VERO) [IPOL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (TDAP).  On 24-May-2022, the patient received a dose of suspect Ipol suspension for injection dose: 10 DF frequency: once lot T1E872M and expiry date 10-Oct-2022 via subcutaneous route in the left arm (strength: unknown) for immunisation.  On 24-May-2022 the patient developed a non-serious event "medical assistant reports that she gave 10 doses (the whole vial) of ipol to a patient with no reported adverse event" (vaccine overdose) (latency: same day).  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.
Information has been received from a certified medical assistant referring to an unspecified number of patients of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On unknown dates between 18-AUG-2016 and 15-NOV-2016, the patients received improperly stored ZOSTAVAX (lot # L037791 with expiration date 30-DEC-2016; lot # M010486 with expiration date 25-MAY-2017; dose and route were unknown. The vaccines were stored under the temperature 15.5 Fahrenheit degree for 1 hour and 11 minutes. A digital data logger was involved. There was no previous excursion for ZOSTAVAX. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
runny nose; Lymph nodes in my left armpit are sore; diastolic blood pressure has gone up and it is now mostly around 100, and systolic ranges from 130 to 160; diastolic blood pressure has gone up and it is now mostly around 100, and systolic ranges from 130 to 160; I have been generally not feeling well compared to before the vaccination; cough; head congestion; This is a spontaneous report from a contactable consumer. This consumer (patient) reported for himself that a 51-years-old male patient received first dose of BNT162B2 (Pfizer-Biontech COVID-19 Vaccine, solution for injection, batch/lot number: 59267-1000-01/EW0161), via an unspecified route of administration in left arm on 19Apr2021 12:00 (at the age of 51-years-old) as single dose for COVID-19 immunisation at pharmacy or drug store. The patient's medical history and concomitant medications were not reported. The patient neither received other vaccine in four weeks nor other medications in two weeks. He had no known allergies. It was unknown if covid prior vaccination. Not tested covid post vaccination. It was unknown, if the patient was diagnosed with COVID-19 prior to vaccination and since the vaccination, the patient had been not tested for COVID-19. The device date was 02May2021. On 19Apr2021 12:00, the patient experiencing some health issues after taking the first dose of the Pfizer COVID-19 vaccine. Not sure if he should go for the second dose scheduled for 10May21. He took the first dose on 19Apr2021, since 19Apr2021 12:00 (then) he had been generally not feeling well compared to before the vaccination, did experience cough, head congestion, and runny nose. On 19-APR-2021 12:00, lymph nodes in his left armpit were sore, he was vaccinated in the left arm. It was getting better but not his normal self. Typically, when he was physically active his blood pressure stayed under control, but he noticed that his diastolic blood pressure had gone up and it was now mostly around 100, and systolic ranges from 130 to 160 (start date: 19-APR-2021 12:00) whenever he took readings at home after the vaccination. The patent had started taking AMLODIPINE 2.5MG tablet since 01May2021 but it was not helping much (corrective for blood pressure up). No treatment for all other events. The outcome for all the adverse events was unknown.  No follow-up attempts are needed. No further information is expected.
While giving the injection, the vaccine leaked out due to a defective syringe. Some vaccine also sprayed down the patient's arm but she was not otherwise harmed. It is estimated that the patient received less than half of a dose.
04/21/2021- First thing in the morning, walked to the bathroom, a few feet from bed, and passed out, hitting my head, lips cut, head cut, bruises on the side of my face, not sure what I hit when I landed. I did not call 911, I called for help and went downstairs and stayed downstairs for 3 days, I had fatigue and pain from injuries, I remained in a state of lethargy and pain for a week following this event. I let my Doctor know the day after I passed out 04/22/2021. May 9th, 2021, I passed out again and went to ER. May 11th, went to doctor she told me to have someone with me all the time . May 12th, 2021 I went into hospital at 10:00AM and I was hospitalized for observance until May 14th, 2021. My heart was stopping for a few seconds and then on May 14th, 2021, it stopped for 21 seconds. On Friday May 14th, 2021 they put a pace maker in me but I had no prior heart issues. I was released on May 15th, 2021. I have had 5 different appointments including a stress test since the pace maker implant. On Friday July 23rd, 2021 I had thyroid lab work and it is finally starting to stabilize.
SWELLING ARM; BULGING OF THE VEINS; ARM SORENESS/TENDERNESS; This spontaneous report received from a patient concerned a 58 year old female. The patient's height, and weight were not reported. The patient's past medical history included cancer 11 year ago, and concurrent conditions included lymphedema in right arm, high blood pressure, penicillin allergy, and allergic to some high blood pressure medicine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, and expiry: UNKNOWN) dose was not reported, administered on 24-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced swelling arm. On 2021, the subject experienced bulging of the veins. On 2021, the subject experienced arm soreness/tenderness. Laboratory data (dates unspecified) included: Diagnostic ultrasound (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from swelling arm, and arm soreness/tenderness, and the outcome of bulging of the veins was not reported. This report was non-serious.
pt recvd vax & while walking to car became dizzy brought back into clinic; pt fainted for approx 10 secs; BP 102/60, P78, R 116; drank juice; felt better w/in 10 mins.
sick; not feeling good; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 60 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Unknown date), for Covid-19 immunization, reaction(s): "sick", "Not feeling good", "body aches/ Pains". The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "sick"; MALAISE (non-serious), outcome "unknown", described as "not feeling good".  Additional information: the day after the covid vaccine patient was sick and it happened patient have had all 3 shots of Pfizer. After the first shot patient was sick the next day with body aches and pains and same with and just not feeling good the same with after the second shot patient just felt terrible the next day patient got the third booster and the next day patient threw up patient was nauseous when patient woke up and a / the day after the covid vaccine patient was sick and it happened patient have had all three shots of pfizer after the first shot patient was sick the next day with body aches and pains and same with and just not feeling good the same with after the second shot i just felt terrible the next day patient got the third booster / and the next day I threw up patient was nauseous when patient woke up and a nauseous.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
100 year old patient in reasonable health (reading, socializing, doing Zoom calls, etc.) took second Pfizer vaccine on February 5, 2021. On the morning of February 22, 2021 the patient suffered a major hemorrhagic stroke. He suffered severe paralysis, could not speak, and suffered from severe pain. Within 24 hours he was moved to Hospice Care. A day later on February 24, 2021 he died.
rash; swelling; fever; pain; This case was reported by a consumer via interactive digital media and described the occurrence of rash in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 8th November 2021, the patient received the 2nd dose of Shingrix. In November 2021, less than a week after receiving Shingrix, the patient experienced rash, swelling, fever and pain. The patient was treated with non-drug therapy (Ice Pack (No Medication)) and paracetamol (Tylenol). On an unknown date, the outcome of the rash, swelling, fever and pain were unknown.   It was unknown if the reporter considered the rash, swelling, fever and pain to be related to Shingrix.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient got the Shingrix series of shots for shingles, the 2nd one on Monday from the day of reporting, 8th November.  The 2nd one had given the patient a rash, swelling, fever.  The reporter asked what could he/she take to alleviate the pain and swelling of the rash.  The patient was icing it and taking Tyleno. No contact details were available.
This spontaneous report as received from a pharmacist refers to a 53 year old female patient with no pertinent medical history or drug allergies. On 05-MAR-2013 the patient was vaccinated with ZOSTAVAX lot # H021712; expiry date: 06-MAR-2014, subcutaneous with no concomitant medication. On 12-MAR-2012, "about 1 weeks after", the patient began to experience pain at her elbow and shoulder joints, extreme itching under her fingers, on eyelids, roof of mouth and inner ear (no rash present) and the insertion arm, from shoulder to elbow, were red and hot. The outcome of was reported as recovered on an unspecified date in 2013. No treatment was given. No lab tests were performed. Additional information has been requested.
Large 10 cm area of redness noted in (L) UA 1 day after vaccination. Area was assessed by ANP. No fever. No axillary adenopathy. Using arm. Denies pain. TX: Cool compresses; observe and monitor for S/S infection. Mom will follow up as needed.
patient received two doses of FLUZONE QUADRIVALENT this year with no adverse event; Initial information received on 30-Nov-2021 regarding an unsolicited valid non-serious case from an other health professional via Agency (under reference 00878749).  This case involves an 88 years old female patient who received two doses of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE] this year (extra dose administered).  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  The patient had no other concomitant vaccines  The patient received 0.5 mL first dose of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED (lot UJ696AA and expiration date: 30-Jun-2022) via intramuscular route in the left arm on 25-Oct-2021 and 0.5 mL second dose of same vaccine in the right arm on 19-Nov-2021 for prophylactic vaccination.  It was a case of an actual medication error due to extra dose administered (same day latency).  It was reported "Medical Assistant reported that a patient received two doses of FLUZONE QUADRIVALENT this year. The caller would like to know if there are any adverse events to monitor for and how to proceed. The first dose was administered on 25OCT2021 and the second dose was administered on 19NOV2021. The caller reported that the patient has not reported any adverse side effects or adverse events."  At time of reporting, no adverse event 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 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.
onset of tinnitus after receiving vaccines.; dizzy; vertigo; m brain fog like when people get COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (onset of tinnitus after receiving vaccines.), DIZZINESS (dizzy), VERTIGO (vertigo) and FEELING ABNORMAL (m brain fog like when people get COVID-19) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TINNITUS (onset of tinnitus after receiving vaccines.), DIZZINESS (dizzy), VERTIGO (vertigo) and FEELING ABNORMAL (m brain fog like when people get COVID-19). At the time of the report, TINNITUS (onset of tinnitus after receiving vaccines.), DIZZINESS (dizzy), VERTIGO (vertigo) and FEELING ABNORMAL (m brain fog like when people get COVID-19) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided. no treatment medication was provided.
Complained of left arm swelling, ache, joints pain, sore throat and swelling, fever 101-102 F, difficulty swallowing, itchiness.  Generalized rash, and stiffness on neck on 3/18.  Still complaining joints pain, stiffening of neck.  Rash noted on chest.  Takes OTC Benadryl, Tylenol, Ecotrin aspirin, and Valium for sleep 3-27-08.
Lymph node swelling in axilla left arm after receiving my booster of the Pfizer COVID vaccine. This lasted for about 3 -5 days then resolved.  This is the same arm I got the first and second shot.
Redness, swelling below injection site, 2 days later 2 x 5 cm was bigger.
FLUMIST rec'd 11/5/12. Mother reports fever, (up to 101 degrees), runny nose, severe sore throat and cough began 11/6/12. 11/8/12 Seen in office with fever of 100.1 and above symptoms. URI diagnosed. Seen again in this office 12/28/12 had been put on OMNICEF elsewhere. Dx cervical adenitis resolving. To complete OMNICEF & if worse to return. Has not returned.
Information has been received from a physician concerning a 20 year old female with egg allergy who on approximately 13-MAR-2009, two weeks ago, was vaccinated with a dose of GARDASIL. The physician was not sure if this was the first or second dose of GARDASIL, as the patient was vaccinated in another office. The patient had experienced fevers of 101F since she was given the GARDASIL vaccine. The patient was not recovered at the time of this report. It was reported that the patient came to the physician's office for evaluation if the fevers. Additional information has been requested.
mild headaches, chills, body ache, severe fatigue, mild nausea. temp 99.7
Acid reflux; Mouth dry aggravated/Dry mouth flare; Dry eyes aggravated/Dry eyes Flare; Eczema aggravated/Eczema Flare; Sinus disorder/Sinus issues; This spontaneous case was reported by a consumer and describes the occurrence of SINUS DISORDER (Sinus disorder/Sinus issues), GASTROOESOPHAGEAL REFLUX DISEASE (Acid reflux), DRY MOUTH (Mouth dry aggravated/Dry mouth flare), DRY EYE (Dry eyes aggravated/Dry eyes Flare) and ECZEMA (Eczema aggravated/Eczema Flare) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis (Moderate to severe rheumatoid arthritis), Dry mouth, Dry eyes and Eczema.   On 21-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free, first dose. In 2021, the patient experienced SINUS DISORDER (Sinus disorder/Sinus issues), DRY MOUTH (Mouth dry aggravated/Dry mouth flare), DRY EYE (Dry eyes aggravated/Dry eyes Flare) and ECZEMA (Eczema aggravated/Eczema Flare). On an unknown date, the patient experienced GASTROOESOPHAGEAL REFLUX DISEASE (Acid reflux). At the time of the report, SINUS DISORDER (Sinus disorder/Sinus issues), GASTROOESOPHAGEAL REFLUX DISEASE (Acid reflux), DRY MOUTH (Mouth dry aggravated/Dry mouth flare), DRY EYE (Dry eyes aggravated/Dry eyes Flare) and ECZEMA (Eczema aggravated/Eczema Flare) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  on an unknown date, the patient experienced acid reflux. in 2021, the patient experienced sinus issues since covid booster, dry mouth flare, dry eyes flare and eczema flare.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The causality for the co-suspect Humira with respect to all the events were not provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 24-Mar-2022: Additional information received on 24-Mar-2022 and included patient demographics, new events information, reporter opinion of causality, suspect drug information and narrative description were added.
Unexpected menstruation- menstruated  twice in  course of a 2 week period.
Complained of SOB, chest heaviness over phone. Appt. in clinic, was feeling better by then. Dr ordered NST for reassurance.