chrisvoncsefalvay/vaers-outcomes huggingface dataset:
At first, severe nausea leading to black out. When consciousness returned, utter lethargy leading to total disability, tinnitus in the right ear, and cold sores on the lips and corner of lips. At present, I have improved with the total lack of energy, but tinnitus and cold sores still randomly appear out of nowhere.
The patient is stating that her arm continues to hurt even after the injection. The patient is also stating there is some numbness along the arm that has not subsided and has continued since the shot.
In 2022, around the end of July or in August, I noticed I was having general dizziness and unsteady on my feet.  It would last maybe 30-40 seconds.  A month later I had another episode that lasted about 5 minutes and I had to sit down.  The third episode lasted about 2-3 hours.  I visited a cardiologist at a regularly scheduled.    I began physical therapy for 4 weeks.  I was diagnosed with vestibular hypofunction. Since then, I have had a couple of episodes but after I do my exercises it resolves.
pt recvd vax & devel red area around inject site; small area progressed to a larger red area w/ blisters; local rxn to vax; pt was walking funny; area of rxn midly uncomfortable;
Got hepatitis B shots on 8/25/04 and 9/29/04. Every since he got the second shot, he gets swelling where his liver and pains where his liver is and on the other side too. His stomach hurts from time to time. Follow up 02/04/05: Recovery status is unknown, because he's been sick off and on since he got the first shot. He still has one more to get. We don't know if he should get the third shot or not.
tingling in arm; Falling sleep; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (tingling in arm) and SOMNOLENCE (Falling sleep) in a female patient of an unknown age 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PARAESTHESIA (tingling in arm) and SOMNOLENCE (Falling sleep). At the time of the report, PARAESTHESIA (tingling in arm) and SOMNOLENCE (Falling sleep) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  No treatment information was provided.   Reporter did not allow further contact; Sender's Comments: Very limited information regarding this events has been provided at this time. The reporter did not allow further contact.
Inappropriate dose for patient's age, should have been 0.5 mL for pediatric dose.
Per RN, patient told her she had 2 vaccines Wednesday, 5/10/17, HPV and MCV4, and Wed. evening her left arm swelled at the vaccine site, and her arm was a little numb and tingling. Her mother gave her ibuprofen and aceta. She reported nausea and vomiting on 5/12/17 and was advised to go to ED if worsens.
Tingling throat; This is a spontaneous report from a contactable physician. This physician reported the same event for two patients. This is the first of two reports. A patient of unspecified age and gender received the first dose of the bnt162b2 (BNT162B2; also reported as COVID-19 vaccine; unknown lot number, NDC number and expiration date), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was also reported that it was unknown if other products were received or if an investigation assessment was performed. On 16Dec2020, the patient experienced: tingling throat (non-serious).  The physician called regarding the COVID-19 vaccine since they had two events that happened on 16Dec2020; however, the physician stated she needed to ask a question before speaking with Pfizer's Drug Safety Unit (DSU) and reporting the events. The physician stated that two patients reported tingling in their throats during the observation period after the vaccine was administered. The physician thought "they just panicked and overreacted " and she did not think they had a reaction. The patients did go the ER (emergency room) and were discharged the same day. The physician wanted to be able to give the second dose. The physician wanted to ask about the side effects of the vaccine. The outcome of the event was unknown.   The batch/lot numbers for the vaccine, BNT162B2, were not provided and will be requested during follow up.   ; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020504906 same reporter/drug/event, different patient
Breakthrough case after Covid vaccination. Dose #1 3/19/2021 Dose #2 04/16/2021. C/O fever, chills, runny nose, muscle aches, loss of taste/smell, headache, fatigue, cough, SOA, nausea/vomiting
Chills, Fever 100.6, Joint/Muscle Pain,  Fatigue, Injection Site Arm Pain, Abdominal Pain, Unable to work.
lymphadenopathy 5th-7th day after first dose, pain at site second dose 1 day
On 4/20 I started having a sore throat and I ended up doing a home test which came back negative. On the 23rd I was still feeling poorly and was planning on visiting my daughter and wanted to make sure I was not COVID-19 positive in which case I would have cancelled the trip. I tested twice that day and both came back negative so did end up visiting her that Sunday. On Monday I was still not feeling well, coughing, sneezing, and the sore throat continued. I called my doctor's office, and they could not get me so they sent me to urgent care. Tuesday the 26th I did go to urgent care tested positive on a PCR test. Today I am still symptomatic, but the sore throat has calmed down. I did get the Monoclonal antibody treatment last night and if I am symptom free on Monday, I will be able to return to work.
Information has been received from a licensed practical nurse concerning a patient who on 29-OCT-2007 was vaccinated SC with a 0.5 mL dose of varicella virus vaccine live (Oka/Merck) instead of a dose of zoster vaccine live (Oka/Merck). It was reported as a medical error, another nurse grabbed the wrong vaccine. No adverse experience was reported. A product quality was not involved. Follow-up information has been received concerning a 76-year-old male patient who was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) (lot# 658061/1092U). The reason for the product confusion was that one nurse pulled the vaccine out of the refrigerator and drew it up. That nurse was called away and another nurse just took it and administered it. Additional information is not expected. This is one of several reports received from the same source.
pt vax 3rd hepta B. in feb90. pt devel increase in monocyte count.
No adverse event; Gave a patient the moderna monovalent vaccine instead of bivalent booster dose; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Gave a patient the moderna monovalent vaccine instead of bivalent booster dose) and NO ADVERSE EVENT (No adverse event) in a 9-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR6965B) for COVID-19 prophylaxis.     No Medical History information was reported.         For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Gave a patient the moderna monovalent vaccine instead of bivalent booster dose).    No concomitant product reported by the reporter. It was unknown if patient had allergies to medication, foods and other products.  It was unknow if patient had ever been diagnosed with and or tested positive with COVID-19. Chronic and Acute illness at the time of vaccination and up to one month before was unknown. No treatment medication reported by the reporter.
Both arms hurt for almost a week; Didn't feel good for about 4 days; Both in bed for 2 days/couldn't get out of bed; Got sick/felt sick for 4 days.; Fever of 102/My fever was 100.7; Vomited; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Both arms hurt for almost a week), MALAISE (Didn't feel good for about 4 days), BEDRIDDEN (Both in bed for 2 days/couldn't get out of bed), ILLNESS (Got sick/felt sick for 4 days.) and PYREXIA (Fever of 102/My fever was 100.7) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (she and her husband both had COVID a year ago.) in 2020.    On 06-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (Both arms hurt for almost a week), MALAISE (Didn't feel good for about 4 days), BEDRIDDEN (Both in bed for 2 days/couldn't get out of bed), ILLNESS (Got sick/felt sick for 4 days.), PYREXIA (Fever of 102/My fever was 100.7) and VOMITING (Vomited). The patient was treated with PARACETAMOL (TYLENOL) in August 2021 for Fever, at an unspecified dose and frequency. In August 2021, PAIN IN EXTREMITY (Both arms hurt for almost a week), MALAISE (Didn't feel good for about 4 days) and ILLNESS (Got sick/felt sick for 4 days.) had resolved. At the time of the report, BEDRIDDEN (Both in bed for 2 days/couldn't get out of bed), PYREXIA (Fever of 102/My fever was 100.7) and VOMITING (Vomited) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In August 2021, Body temperature: 102 (High) fever and 100.7 (High) fever.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication  was not provided.  Caller stated that  the second dose is coming up on this Saturday.   This case was linked to MOD-2021-301975 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 02-Sep-2021: Follow up received on 02-sep-2021 contains significant information( as reported of fever updated)
1st shot October 2020, never got 2nd; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in October 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. No more information was currently available. The reporter did not consent to follow up.
wiped herself there was blood on the toilet paper and "quite a bit in my pajamas".; cramps; distressed; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number ER8730 and expiration date Jul2021) via unknown route on 01Apr2021at 16:00 at single dose for COVID-19 immunisation. Patient reported that she was allergic to bee stings so her doctor told her she should wait 30 minutes after getting the vaccine to observe for any reaction instead of the 15 minutes. The patient concomitant medications were Zydus, USP 75 mg Venlafaxine HCl (EFFEXOR XR).  Patient was fine and left, when she got to her car she took 2 Tylenol and went to the grocery store and did some errands. 4 hours later, patient took 2 more Tylenol. Patient reported that this morning (02Apr2021) she got up from bed to go to the bathroom and noticed that when she wiped herself there was blood on the toilet paper and "quite a bit in my pajamas". Patient reported she was experiencing cramps. Patient believes she's having her period. Patient sounded distressed, reported that she hasn't had a period in years and now she is anxious and scared. Is really scared and wanted so seek medical advice. Unable to contact personal doctor, Declined ISI, cold transferred to PMI due to hold time. Will fax AE for side effects. Patient reported that yesterday she also started a new dose of her Effexor which was increased from 37mg to 75mg which she takes for anxiety and depression, she took the first increased dose yesterday evening and doesn't know if that is what caused this or the Covid shot. Her second dose is scheduled for 29Apr2021. Patient reported that she called her General Practitioner who was not in the office today and her GYN who hasn't yet called her back but she reports that the nurse instructed her to go to the walk in clinic for evaluation, but the caller reports she don't want to go because of the Covid. She spoke with someone before speaking to this agent saying they read her a bunch of information but it was not clear if she spoke with safety or customer service. Obtained the lot number for her first vaccine dose with exp. Patient stated 'I'm a nervous wreck" asking, if the symptom she was experiencing is from her Covid vaccine. Patient asked if her second shot supposed to be more than 21 days from the first. The case was reported as non-serious. Upon callback, she stated she has had a really bad day and spent all afternoon at the walk in clinic. She found out her symptoms were not related to the vaccine and said she could not talk anymore because she was driving. Callback made but caller said she could not talk and did not request a callback. The outcome of the events was unknown.   Additional Information is requested.
diagnosed with Covid-19; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (diagnosed with 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 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Jan-2021, the patient experienced COVID-19 (diagnosed with Covid-19). At the time of the report, COVID-19 (diagnosed with Covid-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Jan-2021, SARS-CoV-2 test: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported. No treatment information provided.  Company comment: This spontaneous case concerns a patient of an unknown age and gender with no details on relevant medical history, who experienced the unexpected non serious event/AESI of COVID-19 after mRNA- 1273 Moderna vaccine. The event occurred approximately 11 days after the first dose of mRNA- 1273 vaccine. Very limited information is available regarding symptoms and clinical course. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a patient of an unknown age and gender with no details on relevant medical history, who experienced the unexpected non serious event/AESI of COVID-19 after mRNA- 1273 Moderna vaccine. The event occurred approximately 11 days after the first dose of mRNA- 1273 vaccine. Very limited information is available regarding symptoms and clinical course. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.
2 days after receiving dT vaccine pt experienced tightness in jaw bilaterally and burning sensation and fatigue in jaw--day 4 started feeling burning sensation where tendons attach to base of skull with  fatigue in back of neck- now, 5 months later still has same sx but occ migratory fatigue and strong aching posterior left shoulder- also exeperiences  fatigue in jaw muscles with chewing after 1 minute and has to stop chewing and then can start eating again.
Cecliian received her DTAP vaccine in her right thigh. she developed a large warm nodule and pain during the days after the immunization and gradually pain and redness resolved (but a small nodule remains). The vaccine was given in the anterior lower (distal) half of the right thigh which may have continuation to the reaction.
tingling lips and scratchy tongue Narrative:  Within minutes of receiving vaccine patient reported tingling lips and tongue feeling scratchy. Administered at outpatient clinic so taken to urgent care where they were treated with Methylprednisolone Inj 125mg IPV and Diphenhydramine Inj 25mg IVP
Patient woke up on 8/14 with bilateral lower extremity swelling and periorbital edema, 7 days after her COVID-19 vaccine (dose #1). Had 3+ protein via urine dipstick on 8/14 and 4+ protein via urine dipstick on 8/16. Symptoms continued despite starting on prednisone 20 mg.  Presented to Hospital ED on 8/23. Nephrology consulted on admission and recommended albumin infusion followed by lasix x2. Patient tolerated her 2 albumin infusions and lasix well. US LE were obtained to assess for DVT and were negative. Patient remained hemodynamically stable on room air throughout admission. At time of discharge, patient on room air and sent home with plan for follow up with nephrology in 3 weeks with 60 mg of prednisone per day. Pt informed by nephrology that she should get her second covid vaccine approx 1 week after originally scheduled date.
Was given Pfizer 5-11 Bivalent Booster instead of the Pfizer 6m-4y Bivalent Booster
left shoulder lession, shave biopsy: invasive well differentiated squamous cell carcinoma, ketatoacanthoma type
has a very big swelling in his left armpit area; the size of the inflammation/is very big.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 31 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 08Jan2022 11:30 (Lot number: 331308A) at the age of 31 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose: 01, Lot Number / Expiry Date: EP7533, Unknown expiry, Route, Anatomical Location: Left arm), administration date: 05Apr2021, when the patient was 31 years old, for COVID-19 Immunization; Bnt162b2 (Dose: 02, Lot Number / Expiry Date: EW0173, Aug2021, Route, Anatomical Location: Left arm), administration date: 03May2021, when the patient was 31 years old, for COVID-19 Immunization. The following information was reported: SWELLING (non-serious) with onset 10Jan2022, outcome "not recovered", described as "has a very big swelling in his left armpit area"; INFLAMMATION (non-serious) with onset 10Jan2022, outcome "not recovered", described as "the size of the inflammation/is very big.". The event "has a very big swelling in his left armpit area" was evaluated at the physician office visit. Additional information: The reporter reported on behalf of her husband. She wanted to report that he got his vaccine on 08Jan2022, Saturday, and on 10Jan2022 he has a very big swelling in his left armpit area. States that he got the shot in his left arm. She states that they have consulted with their medical center and the healthcare provider told them it was normal but adviced to call us and report. He went to the medical center and they said to call Pfizer and that they are unable to do anything and it wasn't normal but they don't know what to do. he went to the Medical Center and they gave him 2 days off of work. There was no information regarding the size of the inflammation in the reports. No Additional Vaccines Administered on Same Date of the Pfizer Suspect. No Prior Vaccinations (within 4 weeks). prior to the first administration date of the suspect vaccine no list of other vaccinations within four weeks. No AE(s) following prior vaccinations.  Follow-up attempts are completed. No further information is expected.
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On 06-JUN-2017, the patient received an expired dose of RECOMBIVAX HB injection (lot # L018500 with expiration date at 13-APR-2017; dose, route of administration and anatomical location were not reported), for prophylaxis. No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Swelling of arm pit/Swelling of site where shot was given/Baseball size; Chills; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), MYALGIA (Body aches) and VACCINATION SITE SWELLING (Swelling of arm pit/Swelling of site where shot was given/Baseball size) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018P21A, 030B21A and 026A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 22-Nov-2021, the patient experienced CHILLS (Chills) and MYALGIA (Body aches). On 23-Nov-2021, the patient experienced VACCINATION SITE SWELLING (Swelling of arm pit/Swelling of site where shot was given/Baseball size). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency. On 22-Nov-2021, CHILLS (Chills) had resolved. On 23-Nov-2021, MYALGIA (Body aches) had resolved. At the time of the report, VACCINATION SITE SWELLING (Swelling of arm pit/Swelling of site where shot was given/Baseball size) had not resolved.            Concomitant medications were not provided.
Mom reported a lump at injection site. Lump described as half the size of a softball. Warm to touch, not painful, no fever.
The first day it was just a normal sore arm, and there was a normal sore arm, and then 11 days after the vaccine was administered I noticed redness and soreness on the left arm, and today the red spot was the size of the palm of my hand and raised, and hot to the touch, I gave my doctor's office a call and took tylenol and put ice on the site.
Swollen left arm- inflammation and tender still sore and swollen 2 days later. Pain in arm started on way home from clinic after Varicella given.
This spontaneous report was received from a pharmacist refers to a 12 year old patient of unknown gender. Medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, a dose of ZOSTAVAX (dose, frequency, strength, route and lot number were not reported) was inadvertently administered to the patient instead of VARIVAX. No adverse effects were reported and no product quality complaint was involved. Additional information has been requested.
speech slurred (sounds that cause lips to round like o, ou, oy, w).  sensory sensitivites have spiked 3 months post vaccine as well.11/30/09 Medical records received for DOS range 8/16/09 - 10/9/09. Final DX: Dysarthria C/O speech changes described as an "accent."  All PEs normal including neuro, and ENT. Diagnostics WNL.  Poss behavioral.  Speech changed at birthday.
Fever to 102, reddness, warmth of extremity, malaise and fatigue.
A-fibalation 27 hours after vaccine. No prior history of a-fib or any heart issues. Started at hospital 7/13/21, ambulanced to other hospital twelve hours later, released 7/16/21.