chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; Patient received vaccine beyond its use by date. Vaccine expired on on 5-23-23 and was used to administer vaccination on 5-25-23; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received vaccine beyond its use by date. Vaccine expired on on 5-23-23 and was used to administer vaccination on 5-25-23) and NO ADVERSE EVENT (No adverse event) in a 79-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 011H22A) for COVID-19 prophylaxis.     Patient did not received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 25-May-2023, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 25-May-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received vaccine beyond its use by date. Vaccine expired on on 5-23-23 and was used to administer vaccination on 5-25-23). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received vaccine beyond its use by date. Vaccine expired on on 5-23-23 and was used to administer vaccination on 5-25-23) 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 EXPIRED PRODUCT ADMINISTERED (Patient received vaccine beyond its use by date. Vaccine expired on on 5-23-23 and was used to administer vaccination on 5-25-23).    No concomitant information was reported. No treatment information was provided.
"Covid arm" symptoms at injection site. Light red rash approx. 2" tall, 1.5" wide, warm to the touch. Very slight swelling. Does not itch. Does not hurt unless significant pressure is applied. 0/10 pain when not touching it, 1/10 when applying pressure. I first noticed it on the evening 7 days after receiving the vaccine. It doesn't seem like a big deal and the news stories about it say it isn't bad so I'm not worried about it, but I figured I'd report it anyways for your statistics.
syringe was faulty / caused some of the medication to leak out while injecting / unsure of the actual amount of volume the patient received; This case was reported by a other health professional via (Shingrix GSK Chatbot) interactive digital media and described the occurrence of underdose in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th June 2021, the patient received Shingrix. On 19th June 2021, unknown after receiving Shingrix, the patient experienced underdose. On an unknown date, the outcome of the underdose was unknown.  Additional details were reported as follows: The age at vaccination was not reported. The reporter stated that, syringe was faulty and caused some of the medication leaked out while injecting and was unsure of the actual amount of volume the patient received, which led to underdose. The reporter was asking if it would be appropriate to re-vaccinate.
1) Had severe fatigue for a couple of months doing any physical activity other than walking that is better the last month.  2) I have allergies that cause sneezing, runny nose.? most of the time it lasts one day. couple of days per month. They are much more severe this year than prior years which I attribute to the vaccine.  Neither event caused me to consult a physician yet.
She was shaking all over; she was trying to throw up; She felt pretty bad; This is a spontaneous report received from a contactable consumer (patient husband). A 86-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6204, NDC number: unknown, Expiry date: 30Jun2021), via an unspecified route of administration on 05Mar2021 (age at vaccination was 86 years) as dose 1, single for COVID-19 immunisation. Medical history and concomitant medications were not reported. The reporter says he and his wife had the first shot 5 Mar, Friday and today he thought he was going to lose her. He wondered if patient had a reaction or something to the vaccine. On an unspecified date in Mar2021, the patient was shaking all over and patient was trying to throw up, felt pretty bad. The reporter was trying to see if that was a reaction to the vaccine. Primary care reported as the reporter called them and they said someone would get a hold of them but they are having the same problem, there are so many calls ahead and they are going to know the same thing, she was shaking all over. The reporter just wanted to make sure everything was on the up and up. The patient slept most of the afternoon and got up and was feeling better now. The reporter says they are looking for the phone number to the doctor's office. They are still looking for the number. The reporter says we can continue, and they will keep looking for it. No investigation assessment reported. Outcome of the events was resolved on an unspecified date in 2021.     Follow-up attempts completed. No further information expected.
Since 10/14/21 pt complains of a fluid moving around in his head when he turns over in bed
The first evening 09/27/21 a headache started with some nausea. 09/28/21 I was exhausted with a migraine that continued the next 2 days off and on and would move around my head. My lymph node in left armpit started to swell on 09/29/21 and the injection site has been swollen, red and really sore since the afternoon of 09/28/21.
Patient became very pale and sweaty and was close to passing out.  Patient moved from the bench where he was sitting down to the floor.  I came to check on him and gave him water and orange juice to drink.  I checked his blood pressure twice, approximately 2 minutes apart.  The first blood pressure reading was 73/46mmHg and a heart rate or 46bpm.  The second reading was 110/74mmHg and HR 66bpm.  After the second BP reading, patient stated that he was feeling better.  This was just likely vasovagal syncope.   Patient remained on the floor because it was a cooler location for approximately 15 minutes and was feeling better and went home with his father-in-law and mother-in-law.
Neurological issues with numbing, tingling, burning, pains to various areas of my body.  Primarily to my lower left extremities.  Swelling of lips and fingers.
injection site was possibly too high, pt complains of limited mobility of shoulder and pain night of injection day.
The primary reporter reports patient had injection site swelling after PNEUMOVAX 23; This spontaneous report was received from a medical assistant concerning a 63-year-old female patient. The patient's concomitant medications included unspecified vitamins. The patient's drugs or allergies reactions included sulfasalazine. No information was provided regarding the patient's pertinent medical history or concurrent conditions.   On 28-AUG-2019, the patient was vaccinated with Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23) injection, by intramuscular route, (lot number S012822 has been verified to be a valid lot number, expiration date as 21-FEB-2021), for vaccination (strength, dose number and anatomical site of injection were not reported).   On the same day, the patient had injection site swelling after Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23) was administered. It was reported that the patient recovered from the swelling "after rubbing the area", on the same day. No information was provided if the patient performed laboratory diagnostics or studies performed. The patient sought medical attention.   The causality assessment between Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23) and the event was unknown.
2" by 3" swelling and pinkness in left arm 1/17/17, scattered bumps on neck, not itchy - started on 1/18/17.
DEATH-entered hospital in October and November with Thrombocytopenia. He died!
Feeling of faintness and chest pain resulted in going to the emergency room. It was determined to be inflammation within the chest and I was given a steroid for 6 days. Since this initial event, I have had issues with balance and eye floaters. I continue to have chest pains and feelings of numbness and pain in my left arm.
The arm was swollen, red, warm and felt hard to touch.  MD diagnosed cellulitis at the injection site.
Had flu shot on 11-7-07.  Within 24 hours rash developed on palms of hands and then scattered rash developed.  Child given Benadryl & rash resolved.
While administering the COVID vax 5-11 yr the parents were attempting to hold the patient but he was able to jerk loose. He jerked so forcefully that the syringe came loose from the needle. There were a few small drops of vaccine that leaked down arm. Syringe was noted to be empty so I believe at least 75% or more of volume was delivered. I discussed the situation with the parents and they did not think that redosing was necessary at this time. I agreed. I put a note in the patients chart that extra staff will be needed for suture shots to help provide comfort and safe holds.
She has significant pain in her left wrist/ painful wrist; She has significant pain in her left wrist, she states that she cannot move it, feels like it is broken but it's not; It is swollen and it's really painful; injection site sore; Booster; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 64 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 03Dec2021 (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. Relevant medical history included: "RA" (unspecified if ongoing), notes:  if she went to her HCP she was most likely going to be prescribed Prednisone or another steroid. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Manufacturer unknown), for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 03Dec2021, outcome "unknown", described as "Booster"; ARTHRALGIA (non-serious) with onset 04Dec2021, outcome "not recovered", described as "She has significant pain in her left wrist/ painful wrist"; JOINT RANGE OF MOTION DECREASED (non-serious) with onset 04Dec2021, outcome "not recovered", described as "She has significant pain in her left wrist, she states that she cannot move it, feels like it is broken but it's not"; JOINT SWELLING (non-serious) with onset 04Dec2021, outcome "not recovered", described as "It is swollen and it's really painful"; VACCINATION SITE PAIN (non-serious) with onset 04Dec2021, outcome "not recovered", described as "injection site sore". The events "she has significant pain in her left wrist/ painful wrist", "she has significant pain in her left wrist, she states that she cannot move it, feels like it is broken but it's not" and "it is swollen and it's really painful" were evaluated at the physician office visit. Therapeutic measures were taken as a result of vaccination site pain.  Additional Information: The injection site was not red, hot or swollen and the patient took Advil. The patient would like to know if the pain migrates away from the injection site and in her case to her wrist. The patient also would like to know if Prednisone or other steroid would cause the booster dose not effective. The patient called her  orthopedic who specializes in hand and wrist to ask them about the pain and they informed her since it was because of the vaccine that they could not see her and referred her to her primary care doctor for treatment.    The lot number for bnt162b2 was not provided and will be requested during follow up.
Patient was administered a third dose of rotarix and pedvax which were not needed. This was disclosed to mom by the provider at time of visit. No symptoms have been noted.
turned blue Not at the injection site, but in general; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A 14 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 14 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SKIN DISCOLOURATION (non-serious) with onset 2021, outcome "recovered" (2021), described as "turned blue Not at the injection site, but in general".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Painful arm; chronic pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Painful arm) and PAIN (chronic pain) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 010M20A) for an unknown indication.     No Medical History information was reported.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Jan-2021, the patient experienced PAIN (chronic pain). On 23-Feb-2021, the patient experienced PAIN IN EXTREMITY (Painful arm). At the time of the report, PAIN IN EXTREMITY (Painful arm) and PAIN (chronic pain) outcome was unknown. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) dosing remained unchanged.       No concomitant medication were reported.  No Treatment was reported.   This case was linked to -MODERNATX, INC.-MOD-2021-048422 (E2B Linked Report).; Sender's Comments:  -MODERNATX, INC.-MOD-2021-048422:Crosslinked with dose 2
16 Year-Old Received First Dose; Initial Report Received on 02-Sep-2021  A licensed practical nurse in the US (OH) reported that a 16 year-old male patient (race and ethnicity not provided) received the first dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.   The patient did not have any allergies. No other relevant medical history was reported.  No relevant concomitant medications were reported.  On 16-Aug-2021, a 16 year-old male patient received the first dose of HEPLISAV-B injection (Lot # 934976, expiration date 30-Jul-2022, and NDC # 43528-003-01; serial number not reported) in the left deltoid. No adverse effects were reported.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
5/08/2006 The day of the shots she started screaming for hours. The next day she screamed all day then about 3:00 pm got very quiet for about 2-3 hours.  She then started twitching and it became a full grand maul seizure. Taken by ambulance to er room. Flown accross state by helicoptor to hosp. In the hosp they determined she also had 2 strokes. She developed diarrhea and a rash on the top of her labia. She stayed for 7 days in icu and then 1 day in peds. Put on phenobarbital. Her body still jerks daily in severe spasms for hours. She has seizures almost daily. She went from a normal healthy 5 mo. old back to about a 1 month old the day of the seizure on May 9th.  She cannot hold her head up or control any of her limbs. She has problems sucking her bottle and is undergoing tests to see if she needs a feeding tube. Her hearing was tested at 8 months because she acts deaf.  They say her inner ear is picking up the signal but they dont think her brain is understanding it is hearing any sounds.  She is brain damaged. She is taking trileptal and phenobarbital now after more visits to er room and neurologist but still continues to have seizures almost daily. She is now 81/2 months old but still is like a 1 month old. We go back to neurologist Aug.16th. She is enrolled in a daycare treatment facility daily for therapy. It is called ppeck. They only take disabled cheildren. I am afraid she is getting worse not better. Discharge summaries state wheeze, status epilepticus. msv Medical record states vomiting. msv 1/4/10 She is completely brain damaged. Cannot sit, stand, reach, etc. Also blind and deaf. 60 day Follow-up Information 24-OCT-2006: She is totally brain damaged. She cant see and she cant hear. She still has seizures. she can only do what a brand new born does. No play, no eating (GI tube). She cant even lift her head. Her last MRI showed her brain is shrinking.
Systemic: patient died-Severe, Additional Details: patient expired at the hospital not in the nursing home per, director of nursing, at Nursing Home.
pt recvd vax 15FEB93 & 16FEB93 devel a fever of 101.9; taken to ER & was hospitalized; pt fussy & feeding actively; PE nl; dx dehydration;
Bruising and ecchymosis one day after the injection and severe shoulder pain which is still lingering for several months after the injection.
patient developed symptoms on 11/5, was hospitalized and diagnosed with guillian barre syndrome.
waking up after about hour and hour and half from sleep; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received bnt162b2 (BNT162B2, Solution for injection, Lot number and Expiration date was not reported), via an unspecified route of administration on an unspecified date as unknown, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date consumer stated, I already had a reference number on file I did the safety reporting, but I got some information and my family with my mother who is experiencing the same things that I reported as far as the sleep like waking up after about hour and hour and half from sleep and I just wanted to be added it to the record. Consumer stated, No, it is for me but added to file because everybody is telling me like medical people are telling me they have not heard of this happening you know losing sleep and awaken up from sleep after hour and hour and half. I talk to my mother it happening to her she just got the shot 2-3 weeks ago and its happening to mother in-law got the shot couple month back and this happening to me. The safety report has already been filed I just wanted to add to it I wanted to add that my mother is having the same symptoms as me as far as not able to sleep and my mother in-law is also. The outcome of the event was unknown.  Follow-up attempts are needed. further information is expected.
RASH; This spontaneous report received from a consumer concerned multiple patients. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced rash. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of rash was not reported. This report was non-serious. This case, from the same reporter is linked to 20210840767.
Eyes became red with exudative discharge from medial ducts, sore throat, itchy throat with transient difficulty in breathing.  Pt relates same symptoms when had the seasonal flu vaccine in 2008.  No allergy to eggs.
After the first dose the caller's arm was still sore and tight before the second shot; After the first dose the caller's arm was still sore and tight before the second shot; This is a spontaneous report from a contactable consumer (patient). A 30-years-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EP6955), via an unspecified route on 20Mar2021 as 1st dose, single dose in the left arm for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On 20Mar2021, after the first dose the patient experienced arm was still sore and tight. After the first shot, the patient had arm soreness but nothing that was different from the reports. The outcome of the events was not recovered.  Information on Lot/Batch number was available. Additional information has been requested.
p/vax pt exp malaise & flu-like symptoms; also devel erythema migrans rash below arm on the bicep;
hard lump on arm-dsicolored area; took 6 wk for lump to dissipate;
Patient has a history of Kidney Transplant but received a booster dose in error, instead of a 3rd dose.
Shortness of breath; Profuse sweating at night; Fever; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness of breath), HYPERHIDROSIS (Profuse sweating at night) and PYREXIA (Fever) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (Shortness of breath), HYPERHIDROSIS (Profuse sweating at night) and PYREXIA (Fever). At the time of the report, DYSPNOEA (Shortness of breath), HYPERHIDROSIS (Profuse sweating at night) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medications were reported.
Information has been received from a physician for GARDASIL, a Pregnancy Registry product, concerning a baby whose mother was an 20 year old female with 1 previous pregnancy including 1 spontaneous abortion (miscarriage) and no medical history or concurrent condition who was vaccinated with the third dose of GARDASIL (lot# 661846/1312X) on 27-JUL-2009 then became pregnant. Concomitant medication included PLAN B. The mother's estimated conception date was 10-AUG-2009 (LMP: 27-JUL-2009, EDD: 03-MAY-2010). Method of confirmation was unknown. On 18-NOV-2009, 17-DEC-2009 and 05-JAN-2010, the mother underwent routine ultrasound and results revealed normal. On 28-FEB-2010, at 28 weeks from LMP, the mother delivered a liveborn infant with unspecified congenital anomaly (also reported normal). Upon internal review, infant born at 28 weeks from LMP was considered to be an other important medical event. The mother's experience has been captured in WAES 0909USA02628. Additional information has been requested.
This spontaneous report received from a patient concerned multiple patients. The patient's height, and weight were not reported. The patient's concurrent conditions included mthfr gene mutation, and other pre-existing medical conditions included the patient had family history of mthfr gene mutation. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 09-MAR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 09-MAR-2021, the subject experienced intense pain across neck. On 09-MAR-2021, the subject experienced intense pain in down arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from intense pain across neck, and intense pain in down arm on 09-MAR-2021. This report was non-serious. This case, from the same reporter is linked to 20210441759.
c/o chills, malaise, generalized weakness & fatigue, dec appetite, nausea; dx stomach virus;
Throbbing ache starting in right arm pit. When pain is at it's worst - seems to radiate down arm into hand. Pt. taking OTC ex - str. TYLENOL and ibuprofen.