chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sick; Aches; Tiredness; Muscle pain; Swollen lymph nodes; Not feeling well; This is a spontaneous report from a contactable consumer, the patient. A 67-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via an unspecified route of administration in the left arm on 15Apr2021 at 15:30 (at the age of 67-years-old) as a single dose for COVID-19 immunisation. Medical history included parkinson's. The patient had known allergies to penicillin (MANUFACTURER UNKNOWN). Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. Concomitant medications included pregabalin (LYRICA), clopidogrel bisulfate (PLAVIX) and carbidopa (MANUFACTURER UNKNOWN); all from an unknown date for unknown indication and unknown if ongoing. The patient previously took acetylsalicylic acid (ASPRIN) for unknown indication on an unknown date and experienced drug allergy. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 15Apr2021 at 15:30, after 1 week of 2nd vaccine, the patient experienced sick, aches, tiredness, muscle pain, swollen lymph nodes and not feeling well. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were not taken as a result of reported events. The clinical outcomes of sick, aches, tiredness, muscle pain, swollen lymph nodes and not feeling well were recovered with lasting effects.   No follow-up attempts are needed. No further information is expected.
Patient fainted after receiving Pfizer vaccine at 0925.  Patient lost consciousness and fell to floor, striking left elbow and head on floor.  Patient became responsive to verbal stimulation and touch to arm within 1-2 minutes.  Cool washcloth applied to neck.  Patient able to sit up and drink water within 5 minutes.  Color improved, and patient able to answer questions appropriately.  Patient stated head hurt and left elbow hurt.  No redness, swelling, or abrasions noted on head or elbow.  Concussion precautions reviewed with patient's mother.  Mother urged to get medical care to follow up regarding fall.  Patient discharged to mother's care at 0955.  Attempted to follow up with family 12/13, 12/14, and 12/15.  Voicemail messages left.  Mother returned call and stated she did not get follow up care for pt., since she was fine when we got in the car, said elbow and head no longer hurt, and asked to get lunch.  Mother denies pt. having any further symptoms.  Mother states she will call and notify PCP of event today.
1/9/12 Post injection- localized soreness, a week later developed fever and itching which lasted 1-1.5 weeks. No distinct rash was seen. Returned to clinic 3/15 to receive 2nd dose, reported symptoms during screening, referred to in clinic physician.
He got first Pfizer COVID shot March 3 with no problem.   He got second COVID shot March 24, sore arm at the time, but then early AM March 25 and also early AM March 26 he had what was suspected to be seizure (both times).  EEG, MRI are negative, but prolactin level is up, and the episodes were consistent with seizure.  He is now on Keppra, not having any more episodes.
got shingles, had received 2 doses previously/Suspected vaccination failure; got shingles after getting COVID; got shingles after getting COVID; This case was reported by a other health professional via sales rep and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and covid-19. On an unknown date, the outcome of the vaccination failure, shingles and covid-19 were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and covid-19 to be related to Shingrix and Shingrix.     Additional Information: GSK Receipt Date: 15-APR-2022  Reporter's Comments: The patient had 2 doses of Shingrix previously and got shingles after getting COVID.  The reporter thought COVID played a part in patient's acquiring shingles. The reporter agreed to follow up from GlaxoSmithKline (GSK). Additional Supportive Information:  This case described the occurrence of suspected vaccination failure. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting. Note- As it is unknown if the patient experienced Covid after 1st dose or after 2nd dose of Shingrix, it is linked with both the doses.
Shortness of breath, chest tightness, dizziness when standing, weakness, tachycardia, pale for 6 hours, and mild hoarseness.
Patients were administering 0.25 ml instead of 0.5 ml to uncompromised adults/approximately 100 patients were administered lower than authorized dose of the Moderna COVID-19 bivalent booster; No adverse event; This spontaneous case was reported by a physician and describes the occurrence of ACCIDENTAL UNDERDOSE (Patients were administering 0.25 ml instead of 0.5 ml to uncompromised adults/approximately 100 patients were administered lower than authorized dose of the Moderna COVID-19 bivalent booster) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Patients were administering 0.25 ml instead of 0.5 ml to uncompromised adults/approximately 100 patients were administered lower than authorized dose of the Moderna COVID-19 bivalent booster) and NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Patients were administering 0.25 ml instead of 0.5 ml to uncompromised adults/approximately 100 patients were administered lower than authorized dose of the Moderna COVID-19 bivalent booster) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (Patients were administering 0.25 ml instead of 0.5 ml to uncompromised adults/approximately 100 patients were administered lower than authorized dose of the Moderna COVID-19 bivalent booster).    No concomitant product reported by reporter. It was reported that, nurses had no Standing orders other than what they had for the second booster, when first administering Bivalent boosters. So, they assumed the same dose as the second booster, hence they were administering 0.25 ml instead of 0.5 ml to uncompromised adults. It was reported that approximately 100 patients were administered an invalid dose of the Moderna COVID-19 bivalent booster. No treatment medication reported by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-646512 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-646512:MOD-2022-646512: Master case
Metrorrhagia - daily vaginal bleeding (30-60 ml loss per day) starting on 4/23 despite exclusive breastfeeding
2 inch round itchy rash appeared 6 days after vaccine given.  Used hydrocortisone cream several times per day.  Rash disappeared after 6 days.
About 5 days after receiving the injection, I suddenly developed mild shortness of breath, aches, and fatigue. Less than 24 hours later, the symptoms seem to be resolving.
received Prevnar 20 as well as Pneumovax 23 and now wants to get Prevnar 20; received Prevnar 20 as well as Pneumovax 23 and now wants to get Prevnar 20; received Prevnar 20 as well as Pneumovax 23 and now wants to get Prevnar 20; This is a spontaneous report received from a contactable reporter (Pharmacist) from medical information team for a Pfizer sponsored program (004756).  A 52-year-old female patient received pneumococcal 20-val conj vac (dipht crm197 protein) (PREVNAR 20) (Batch/Lot number: unknown) as dose number unknown, single for immunization; pneumococcal vaccine polysacch 23v (PNEUMOVAX 23) (Batch/Lot number: unknown) as dose number unknown, single for immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INCORRECT DOSE ADMINISTERED (non-serious), CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (non-serious), DRUG INTERACTION (non-serious), outcome "unknown" and all described as "received Prevnar 20 as well as Pneumovax 23 and now wants to get Prevnar 20". Additional information: The pharmacist was calling regarding a patient (52-year-old female) who had received pneumococcal 20-val conj vac (dipht crm197 protein) as well as pneumococcal vaccine polysacch 23v and now wanted to get pneumococcal 20-val conj vac (dipht crm197 protein). The pharmacist wanted to know what the "protocol" for doing so.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I woke up and could not stop shaking. My hand was shaking so bad (almost like a Parkinson's type shake) that I could not even put a thermometer in (my hands could not stop shaking); had a fever of about 101; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Jun2022 at 09:00 as dose 4 (booster), single (Lot number: FN2908) at the age of 61 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Chronic daily Migraines" (unspecified if ongoing); "Seasonal allergies" (unspecified if ongoing). Concomitant medication(s) included: GABAPENTIN; CYCLOBENZAPRINE; FROVATRIPTAN; NALTREX. Past drug history included: Levaquin, reaction(s): "Drug Allergy"; Topomax, reaction(s): "Drug Allergy". Vaccination history included: BNT162b2 (DOSE 3 (BOOSTER), Lot number: Fh8030, Vaccine Administration Date: 21Nov2021, Vaccine Administration Time: 09:00AM, Vaccine location: Arm Left), administration date: 21Nov2021, when the patient was 61-year-old, for COVID-19 immunization; Bnt162b2 (DOSE 2, Lot number: En6201,, Vaccine location: Left arm), for COVID-19 immunization; Bnt162b2 (DOSE 1, Lot number: El1284,, Vaccine location: Left arm), for COVID-19 immunization. The following information was reported: TREMOR (non-serious) with onset 20Jun2022 at 01:30, outcome "recovered", described as "I woke up and could not stop shaking. My hand was shaking so bad (almost like a Parkinson's type shake) that I could not even put a thermometer in (my hands could not stop shaking)"; PYREXIA (non-serious) with onset 20Jun2022 at 01:30, outcome "recovered", described as "had a fever of about 101". The events "i woke up and could not stop shaking. my hand was shaking so bad (almost like a parkinson's type shake) that i could not even put a thermometer in (my hands could not stop shaking)" and "had a fever of about 101" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of tremor, pyrexia.  Additional information: She woke up and could not stop shaking. she hand was shaking so bad (almost like a Parkinson's type shake) that she could not even put a thermometer in (She hands could not stop shaking) she could barely keep the thermometer in She mouth because even She mouth was shaking. She had a fever of about 101 and once She took Tylenol the shaking subsided.  No follow-up attempts are possible. No further information is expected.
Within 1 hr of receiving pneumococcal vaccine developed severe pain, swelling, redness and warmth that has persisted over 24 hours, right deltoid.
This spontaneous report was received from a nurse refers to a 01-year-old patient of unknown gender. The patient's relevant medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 20-SEP-2017, the patient was vaccinated with improperly stored M-M-R II (dosing details were not reported) (lot # M045401, expiry date: 14-NOV-2018) for prophylaxis. The lot of M-M-R II were reconstituted with properly stored sterile diluent (DILUENT MRK). No adverse effects were reported. Temperature excursion was from 0 degree Celsius (C) to 1 degree C (0.8 degree C) for 52 minutes. The previous temperature excursion was reported as from 9 degree C to 25 degree C (10.9 degree C) for 3 hours 17 minutes. The call was because of a data logger. No product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA000054: Original Case: 1709USA000054.
Body rash dx as erythema multiforme. After 2nd dose, the rash became severe (reddened and itchy). Also, he had several episodes of severe facial and throat swelling. Treated with prednisone.
Case number PHEH2011US04267, is an initial spontaneous report received from a nurse on 13 Sep 2011 with the follow-up received on 29 Sep 2011: This report refers to 10-years-old male child. He was received only MenCWY liquid conjugate component of MENVEO (batch number A10062) on 31 Aug 2011 without being reconstituted with MenA lyophilized conjugate component and the powdered vial was not used to mix to-gather No adverse event reported. Follow-up received from nurse on 29 Sep 2011: The patient demographics, site of application and date of vaccination were updated.
limp & pale x 3 days; lethargic; vomiting p/every feed x 3 days;
Started 2/15 with joint pain. On 2/20 started with high fever, chills and headache, frequent urination and dehydration. On 2/22 started to vomit continued with other systems. Went to emergency clinic. They thought it was a UTI and prescribed an antibiotic. Antibiotics not working. Admitted to hospital on 2/23. All above symptoms continues. Met with internal dr and infectious disease dr. They believe this is a bladder infection plus a virus. Have been in hospital for three days now. Dr ordered more labs and waiting on outcome.
pt recvd vax & 1 hr later exp hives & anaphylaxis;
Swelling (Edema, edema)(Edema) - recovered/resolved Redness (Rash, rash)(Rash) - recovered/resolved Warmth (Vasodilatation, vasodilatation)(Vasodilat) - recovered/resolved Pain (Pain, pain)(Pain) - recovered/resolved A report was received from an office manager on 11 November 2003 concerning a female vaccinee in her 30's who experienced swelling, redness, warmth and pain on the same day as receiving Fluvirin on 10 November 2003. On 10 November 2003 the vaccinee experoenced swelling, redness, warmth and pain. The pain had been becoming milder at the time of the report. The vaccinee had not recovered at the time of the report. Update 1, 25 November 2003: Further information was received from an office manager on 25 November 2003 indicating that the swelling, redness, warmth and pain experienced by the 33 year old female vaccinee resolved 4 days after onset, on 14 November 2003. There was insufficient information to determine the reporter's causality assessment. No follow up pending.
The patient has had vomiting for the past 5 days. He had not had a bowel movement for 3 days with the exception of a small bowel movement after rectal temperature at ED from which the patient is presenting. He has had no flatus as well. He has had no fevers. He has had decreased urinary output and decreased p.o. intake. The patient's abdominal x-ray at outside showed a small-bowel obstruction. The patient otherwise healthy.
This spontaneous report as received from a registered nurse refers to a patient of unknown age vaccinated GARDASIL (lot # was unspecified. The patient was "administered the first two doses GARDASIL series on 05-JUN-2009 and 03-AUG-2009, respectively, the patient will soon receive the third dose in the GARDASIL series". No adverse effect reported. No treatment information was reported. The outcome of inappropriate schedule of vaccine is unknown. Additional information has been requested.
Within a few minutes of getting the second dose of the vaccine I felt like I was swelling. I was having a little trouble breathing through my mask. When I got home, I was nauseous, and I had a big red lump underneath the area of the shot. That lump was there for a week and the redness and hotness went down. I have a lot of food allergies and I took an extra dose of my allergy medication. I have also had some problems with some of the food allergies that I had introduced back into my diet before the vaccine. A few minutes after getting the second dose of the vaccine I felt very hot and Nauseous. I felt like my face and neck were swollen and I felt like my mask was tighter. I took some extra Allergy medication for the next few days because I felt like I had some trouble swallowing. My food allergies are still happening more often and to some foods that were previously fine.
My right upper arm began aching but the nurse said with the pneumonia vaccine this might happen because the shot is administered in muscle.  I began feeling very cold and then I started shivering.  In about an hour my arm was very hot and becoming quite hard and in a couple of hours my whole arm was about double in size.  I went to bed to try to get warm but nothing helped the shivering or intense cold.  My arm was very very tender and sleeping was very difficult.  I took a couple of motrin every few hours.  This continued all day Sat & Sun later in the day the arm was not as tender and the swelling was diminishing.  Later that day I noticed that my arm was bright pink from the inflammation.  Monday the arm was almost back to its original size but was still quite pink. Today (Tuesday) my arm is still tender and somewhat pink.  I also felt nauseous during this time.
DRUG INDUCED POLYNEUROPATHY HYPOTENSION ACUTE PULMONARY EMBOLISM
moderna booster shot (3rd shot) was approved 8/13/21. Patient was given vaccine booster shot on 8/8/21
REASON FOR ADMISSION Fall, right sided rib fractures, right pneumothorax   HISTORY OF PRESENT ILLNESS  a 70 y.o. man who presents to the Hospital with chest pain, increased work of breathing and massive subcutaneous emphysema status post falling off a 6 ft roof yesterday.  Patient did not hit his head.  He denies loss of consciousness.  He is not on any blood thinner.  He presented to the ED and daily chest x-ray demonstrated several right-sided rib fractures and a small pneumothorax.  Patient was discharged pain meds.  The patient later developed worsening facial swelling and returned to the ED due to concern for an allergic reaction.  Patient was given epinephrine and prednisone and was discharged home.  Patient awoke this morning with increased chest pain and difficulty breathing and presented to Emergency Department.  Initial chest x-ray showed a left-sided pneumothorax with some mediastinal shift.  A left-sided chest tube was placed.  Imaging demonstrated right-sided rib fractures 1 through 7, large right pneumothorax, and large volume pneumomediastinum and subcutaneous emphysema.  Patient also had a left-sided 1st rib fracture.  A CTA of the neck was obtained which showed abnormal mild kinking of the left subclavian/axillary artery at the 1st rib. Patient was also COVID positive. Patient was transported up to the ICU for right chest tube placement and further management.   Upon arrival, patient had HR 80-90's, SBP in 160-170's, and saturating greater than 98% on 3 L nasal cannula.  Patient denies any allergies.  He reports right-sided chest wall pain.  His area decision maker would be his wife. A right-sided chest tube was placed under moderate sedation and confirmed by x-ray.
Suspected Vaccination failure; have had shingles for 3 years above the right eye. Awful; Awful; This case was reported by a consumer via interactive digital media (facebook) and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), ophthalmic herpes zoster (serious criteria GSK medically significant) and feels awful. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the ophthalmic herpes zoster and feels awful were recovered/resolved.   It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster and feels awful to be related to Shingles vaccine.  Additional details were provided as follows: The case reported by the patient herself/himself. The age at vaccination was not reported. The patient received the shingles shot and patient had shingles above the right eye for 3 years. The reporter stated that it was awful. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
9 days after 2nd vaccination prolonged headache started. On day 9 headache and tiredness, this is day 11 and I still have headache. Cant sleep so bad. This is not a migraine per my lifelong migraines, whole head hurts and I cant make it stop, migraine tablets dont touch it.   On days 2-4 post second vaccine, had fever, chills and tiredness. That passed, nothing occurred again until day 9.  I am now day 11.
As of 48 hours later, have a 3-inch diameter welt surrounding injection site (hot, itchy, sore, heavy) and additional small bump at needle injection point.
This spontaneous case, initially received on 17-Nov-2016, was reported by a non health professional and concerns a 57-year-old male patient. Weight: not provided; Height: not provided. Concomitant medication: not reported. Administration of company suspect drug(s): The patient received AFLURIA from 13-NOV-2016 to 13-NOV-2016. Dose regimen: 0.5 ml, Route of administration: Intramuscular. Batch number: WT52005. No additional suspect drugs. Adverse reactions/events and outcomes: On an unknown date 12 hours later, the patient experienced body aches (outcome: Not recovered / No resolved), fever (outcome: Not recovered / Not resolved), a sore throat (outcome: Not recovered / Not resolved) and a stuffy nose (outcome: Not recovered / Not resolved). This is still occurring on 17-Nov-2016. The patient has not been to his local doctor. Reporter comments: The reporter considers all events as non-serious.
Patient had history of anxiety with vaccinations / blood draws. After receiving vaccination, patient was instructed to wait in waiting area for 15 minutes. Approximately 3-5 minutes after receiving vaccine patient fell off chair onto the floor. Patient was unconscious for 3 to 5 seconds. We called paramedics and when they arrived they did some assessments. Patient was okay and was instructed to wait another 15 minutes before leaving.
Patient experienced syncope about 1 minute after receiving the vaccine, falling from a seated position to the floor. Patient was evaluated by EMS on site and released from the clinic to care of his mother who came to drive him home. Follow-up with patient on 4/12/21, patient states he has not experienced any other negative reactions since the syncopal episode and is feeling fine.