chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I woke up at about 11:30pm vomitting and started to panic. I went to the ER at Hospital.  and they told me it was anxiety.
vaccine administered, possibly defective needle/syringe caused some of the vaccine to discharge from the base of the needle where it is attached to the syringe.  as a result, RPh unable to determine if patient received more than half of the dose and per CDC guidance, another dose will be readministered to the patient tomorrow (2/16/2021) in the other arm (RA)
Site of injection began with soreness after one day.  After two days, the site had  about a 2 inch circular area of bright red around it, felt hot, was slightly swollen, was slightly itchy, and was painful to the touch. After three days, the red area got larger but not brighter, and was about 3 inches in diameter, the entire muscle in the arm is swollen and hot and was painful to the touch and it was more itchy.  Today is day 5 and it it still the same, without itchiness so far.  I would say when pressed on, the pain is painscale 5.
Gradually worsening SOB, coughing, wheezing, tachycardia.
2/9 evening: chills, fever, arm pain, fatigue 2/10: fever up to 101, felt overheated, arm pain and felt heavy, headache, body aches, fatigue 2/11 : pain at injection site and swelling, low grade fever, fatigue 2/12: arm swelling more and more, itchy and red. About the size of my whole hand. Nose congestion. 2/13: ?covid arm? rash hot to the touch, pink, very hard, does not feel ice or heat, itchy
Fever of 101 degrees Fahrenheit, chills, and sweating for 24 hours beginning 10-12 hours after receiving the vaccination.
This case was reported by a physician and described the occurene of fever in a 2 month old male patient who received DTaP , hepatitis B recombinant and inactivated poliovirus vaccine combined (Pediarix). On an unspecified date in 2004, the patient received the first dose of Pediarix. On the same day, the patient received injections of Haemophilus influenzae type b conjuage vaccine and 7 valent pneumococcal conjugate vaccine. Approximatley 24 hours after the administration of the immunizations, on an unspecified date in 2004, the patient experienced fever of 106 degrees Fahrenheit. The patient was seen in an emergency room and subsequently treated with paracetamol (Tylenol) and ibuprofen (Motrin). At an unspecified time following the onset of the fever, the event resolved. Follow-up - MD has left practice - No further information available.
I was vaccinated on a Friday afternoon.   That night, I was exhausted and got in bed by 9 and slept for 12 hours.  Very unusual for me.  That's happened several nights this week, including last night which was Thursday.  I could barely get out of bed  this morning  (Friday one week later) after 10 hours of sleep.   Monday, I felt a little flu-like but it passed quickly.    Also, the left side of my face has been tingly on and off since the vaccine.  It's tingly right now.   I has shingles about six years ago on the left side of my face.   The tingly feeling remained on an off long after the shingles.  I had the Shingrex vaccine and have rarely - almost never? - had the tingly feeling again until now.    I'd wait to report until  this resolves itself but I'm afraid I'll not be as motivated to report once things are back to normal.  I'm not reading anything about people with the tingly/shingles-like reaction, so wanted to report.
1.  Started in mid-January 2022, severe bilateral feet pain (burning) becoming chronic and disabling by March.  Each step increases the burning feet pain.  Neurologist prescribed gabapentin and lyrica which did NOT help the pain.  Primary Care Physician prescribed duloxetine (replacing fluoxetine) which did NOT help the pain.  thigh and calf muscles atropied due to non-use from disabling pain, which led to a  20lb weight loss in leg muscles from March through May.  2.  Essential tremor of both hands started in June 2022 and is worsening. 3.  Some difficulty with speech, e.g., stuttering, cannot recall the right word, starting June 2022 4.  Balance problems trying to walk, starting June 2022  ----  OTHER Medical Tes
Metallic taste in mouth started about 5 minutes after injection.  lasted approximately for 1 hour
This spontaneous case reported by an other healthcare professional, describes the occurrence of administered expired product (BUD was Nov 1, 2021 but vaccine administered on Feb 18, 2022) and product storage error (Moderna vaccine stored in refrigerator and administered past the BUD date) in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 011F21A) for COVID-19 immunization. No medical history reported. On Feb 18, 2022, patient received a dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Feb 18, 2022, patient administered expired product (BUD was Nov 1, 2021 but vaccine administered on Feb 18, 2022). On an unknown date, patient experienced product storage error (Moderna vaccine stored in refrigerator and administered past the BUD date). At the time of the report, administered expired product (BUD was Nov 1, 2021 but vaccine administered on Feb 18, 2022) and product storage error (Moderna vaccine stored in refrigerator and administered past the BUD date) outcome: unknown. The reporter did not provide any causality assessments, concomitant medication or treatment information.
pt recvd vax & a brief generalized sz was noted shortly p/arriving back home; pt has seemed well since;
Initial information received on 30-Nov-2018 regarding an unsolicited valid non-serious case received from a nurse via consumer/non-HCP. This case involves 11 patients (age was reported as 3-18 years, gender not reported) who received vaccine FLUZONE QUADRIVALENT which was shipped late (more than 2 days) on an unknown date. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. On 29-Nov-2018 and 30-Nov-2018, the patients received a dose of 0.5 ml suspect Influenza Quadrival A-B Vaccine (lot number: UJ087AA and expiry date: 30-Jun-2019) (dose in series and site of administration was not reported) via intramuscular route in leg or arm. It was a case of actual medication error due to incorrect product storage. 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. List of documents held by sender: none.
The afternoon of receiving the 1st Moderna shot, I developed an involuntary muscle twitch of my eyelid.  The twitch would occur for 1-3 minutes in duration and anywhere from 3-17 times a day.  This twitch lasted for approximately three weeks, at which point I noticed it was no longer occurring.
Client received her 1st Pfizer dose (Lot# FF2587) from RN . on 10/12/21 at 16:22. One to two minutes after receiving the shot, the client communicated to RN. she was feeling lightheaded and had a syncopal episode which lasted 2-3 seconds.  RN happened to walk into the vaccination room at the same time the incident occurred and called out to Lead RN to retrieve an EMT.  While the episode was occurring, RN. held up the client in her chair, and the client began to respond.  Lead RN, went to the observation room to obtain EMT.  He and Lead RN  proceeded to vaccination station 2.  Upon arriving, Lead RN observed that with the assistance of RN, the client was still seated upright in the chair, diaphoretic, and pale in color.  RN was speaking with the client asking how she felt, when the client experienced a 2nd syncopal event that lasted 1-2 seconds.  RN performed a sternal rub, and the client was responsive.  EMT was also with the client asking her name and if she knew where she was, and the client was able to adequately respond.  At 16:25 EMT applied a pulse oximeter on the client?s finger and let it reside there.  The following vitals were noted: (16:25:  HR: 142, SPO2: 93%, 16:28: HR:140, SPO2: 97%, 16:33: HR: 82, SPO2: 99%).  EMT also gave the client an ice pack to apply to her forehead and back of her neck, which she utilized.  Client stated she was hot and exhibited mild shakiness.  Client was given a bottle of water, and crackers, which she ate/drank.  Client stated she had a small snack before coming to get vaccinated, but had not had a full meal since 11:00.  Client and her mother stated the client does not have any underlying conditions, no allergies, and takes no medications.  Client stated she was a little anxious and hesitant about getting the vaccine.  She was only getting it because it is mandated.  Client stated she was starting to feel better.  Client also stated she did not really remember having the syncopal episodes.  She just remembered she was feeling lightheaded and then started to notice her range of vision narrowing.  At 16:39 EMT took the client?s vitals (BP: 131/76, HR: 73, SPO2: 99%).  Client was also given an orange soda, which she drank.  Lead RN observed the color had come back to the client?s face and she was no longer diaphoretic.  Client stated she was feeling a lot better and was ready to try standing up. Lead RN educated the client and her mother on both the potential side effects and adverse effects of the vaccine, when to seek medical attention, and ER precautions.  Lead RN  requested the client and her mother go to the observation room with EMT to be observed for an additional 15 minutes and they agreed.  At 14:55, EMT took the clients vitals (BP: 122/80, HR: 61, SPO2: 99%.  Client stated she felt fine.  Lead RN recommended the client eat a full meal and ensure she is hydrated when coming back to receive her 2nd shot.  Lead RN observed the client exit the observation room with her mother walking with a stead gait.
Gotten her third dose; contracting COVID-19; contracting COVID-19; This is a spontaneous report from a contactable other HCP. A 44-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 3 (booster) via an unspecified route of administration on an unspecified date (at the age of 44 years) (Batch/Lot number was not reported) as a single dose, dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as a single dose, and dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient contracted COVID-19. She has completed 2 doses of Pfizer and has gotten her third dose as well. Outcome of the events was unknown.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: The information provided is very limited to make a meaningful medical evaluation of the case. However, based on the current information available a possible contributory role of the suspect BNT162B2 for the reported events of Covid-19 and Drug ineffective cannot be completely excluded. The case will be reassessed further upon receipt of additional information. 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.
1/9/22 71 yr/o male with a history of hypertension and stroke presenting to the ED for shortness of breath. Significant other called ambulance for breathing difficulties. Patient has had a Covid-like symptoms for 2 weeks. Partner tested positive for Covid. Today partner noted increased shortness of breath and confusion. EMS was called. On scene patient had oxygen saturations in the 50s and was cyanotic. They put him on a nonrebreather and brought him here. Patient is confused unable to provide additional history at this time. Physical Exam Constitutional: General: He is in acute distress. Appearance: He is well-developed. HENT: Head: Normocephalic and atraumatic.
Itchiness at injection site; redness at injection site; Swelling at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itchiness at injection site), VACCINATION SITE ERYTHEMA (redness at injection site) and VACCINATION SITE SWELLING (Swelling at injection site) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K202A) for COVID-19 vaccination.     The patient's past medical history included No adverse reaction (No Medical History Received).    On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Dec-2020, the patient experienced VACCINATION SITE PRURITUS (Itchiness at injection site), VACCINATION SITE ERYTHEMA (redness at injection site) and VACCINATION SITE SWELLING (Swelling at injection site). On 01-Jan-2021, VACCINATION SITE PRURITUS (Itchiness at injection site), VACCINATION SITE ERYTHEMA (redness at injection site) and VACCINATION SITE SWELLING (Swelling at injection site) had 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.   Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Fever, Body Aches, Headache, Fatigue and soreness at injection site.  Symptoms started around 10:00 p.m.  and still continue at this time (1:42 p.m.) on 4/24/2021.
Pt. called 1/31/17 and reported hives and erythematous painful rash after administration of 23 valent pneumococcal vaccine on 1/30/17. Pt. used topical diphenhydramine with no relief, and was instructed to take diphenhydramine 25-50 mg orally TID p.r.n. rash and to visit the ER if symptoms do not resolve or get worse.
excess uterine clotting; enlarged lymph nodes in the auxiliary of left arm.; two uterine cycles every moth; This is a spontaneous report from a contactable nurse (patient). A 32-year-old female patient received the first dose of (Solution for injection), via an unspecified route of administration, administered in Arm Left on 14Jan2021 10:00 (received at the age of 32-years-old) as SINGLE DOSE for covid-19 immunization. The vaccine was administered at a hospital. The patient did not receive any other vaccine in four weeks prior to receiving. Medical history included covid-19 from Nov2020 to an unknown date. The patient was not pregnant and had no known allergies. Concomitant medication included vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]) and multivitamin. Within 48 hours, on 15Jan2021 10:00 AM, the patient had enlarged lymph nodes in the auxiliary of left arm. 16 days after the vaccine, on 30Jan2021, she started having excess uterine clotting and have been having two uterine cycles every month since the vaccine (Jan2021). She stated that she had COVID-19 in Nov2020 and her cycles were normal. She has been checked with her doctor and refereed to a GYN for further testing. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on Apr2021.  The adverse events resulted in doctor or other healthcare professional office/clinic visit. It was unknown if patient received therapeutic measures in response to the adverse events. Outcome of the events was not recovered.
Immediate vertigo and vomiting, heart palpitations. The vertigo lasted for 2 years, every day. I had a low grade fever for over a month, left side facial paralysis/numbness, a stiff neck, headache pain on left side, brain fog for 12 months, an itchy burning rash on back, nausea and vomiting. I was in bed for 7 months.
AREA RED, SWOLLEN, RASHED WITH HEAT. ACHY ALL OVER.
Day of injection 2/17: Sore arm, hard to lift with right arm Feverish but no fever Fatigue  Loss of appetite   Day of 2/18: Felt better but still fatigued  Loss of appetite   Day of 2/19: Moderate-severe diarrhea  Day of 2/20: moderate to severe diarrhea Treated with an anti-diarrhea pill  Day of 2/21:  fatigued and weakness (assuming from diarrhea)   Day of 2/22: weakness and keeping hydrated  Consulting primary care physician on next steps
Chest pain; Tested positive for COVID; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CHEST PAIN (Chest pain) and COVID-19 (Tested positive for COVID) 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 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHEST PAIN (Chest pain) and COVID-19 (Tested positive for COVID). At the time of the report, CHEST PAIN (Chest pain) and COVID-19 (Tested positive for COVID) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported.  Treatment for the event chest pain included antiallergics.
pt recv vax rt deltoid on 3JAN97;c/o swelling, pain & redness starting 4JAN97;c/o pain rt shoulder & neck & pain w/swallowing;examined by MD on 6JAN97;
Patient is 51 years old and received a Fluzone Quad High Dose vaccine. According to CDC: Fluzone High-Dose Quadrivalent vaccine is approved only for people 65 years and older. Fluzone High-Dose Quadrivalent is not approved for people younger than 65 years or for people of any age with a history of severe allergic reaction to any influenza vaccine or to vaccine components other than eggs. Information about vaccine ingredients is located in the manufacturer?s package insert.
This non-serious initial spontaneous case, was received on 18-Oct-2017, from a nurse, concerns a patient of unspecified age and gender. This was 2nd out of 24 reports. On 06-Oct-2017, the patient was administered with FLUCELVAX QIV (dose: full dose (as reported), batch number: 195128, expiry date: 30-Apr-2018, route of administration, anatomical location: not reported). On 06-Oct-2017, employees were given vaccine from a vial that leaked. It was reported that, after piercing the vial, when it was turned upside down and upon injecting air, vial was dripping from the rubber seal (explicitly considered as product leakage). The nurse could withdraw only 7 doses from the vial. The patient was administered with full doses (explicitly considered as drug administration error). There were 2 defective units, but the package was not damaged or wet. The nurse used 23 needle gauge of size 3 cc. The PTC (product technical complaint) number provided for was 1025066. Based on the investigation performed, it can be concluded that FLUCELVAX Batch 195128 was manufactured in compliance with the approved internal procedures and in accordance with the quality requirements. No internal root cause was identified in the manufacturing process, or relating to the vial or stopper components, and no trends were identified for the batch. However a known trend was identified for the FLUCELVAX batches from the 2017/2018 FLUCELVAX Commercial Season for vials leaking at the stopper during dosing due to air being added to the vial. The most likely root cause can be attributed to improper handling by the user. Follow-up received on 21-Nov-2017: Added PTC number and the QA (quality assurance) report results. Narrative amended accordingly. Non-significant case correction received with 18-Oct-2017: The event verbatim for the product leakage was changed.
Patient was given a third Moderna dose of 0.5 mL when a third Moderna dose of 0.25 mL was indicated. This error was communicated to the patient. Patient denied experiencing side effects at time of injection and during the COVID-19 vaccine waiting period following administration of the vaccine.   Paient was called by this individual on 11/03/2021 in the afternoon for a follow-up at which time he denied having negative signs/symptoms of receiving the 0.5 mL dose of Moderna. When asked how he was and had been feeling, he stated he felt "Wonderful!". No adverse effects were identified at the time of documentation.
even sicker; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (even sicker) 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 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 ILLNESS (even sicker). At the time of the report, ILLNESS (even sicker) outcome was unknown.            Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.   This case was linked to MOD-2021-315264 (Patient Link).
headache little bit for 2-3 hours edema - lasted 1 day (24 hours) eye - pupil - dilate. last about 2 hours nausea - still have nausea
first dose of the / vaccine in October-2020 / has not received her second dose; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received 0.5 ml 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. The patient received 1st dose of Shingrix and not received her second dose of Shingrix. Till the time of reporting, the patient did not receive the 2nd dose of the vaccine, which led to incomplete course of vaccination. The reporter did not consent to follow-up.