chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Description of incident: Following administration of second COVID-19 vaccine, patient was sitting in the observation area for his 15 minute watch time. Staff noticed the patient was passed his wait time and noticed the patient was unresponsive in his chair. RN alerted critical response team and patient was brought back to the triage area outside of the gymnasium. Patient was somewhat more responsive to his name upon arrival to triage area. Blood pressure taken at 1435 and blood pressure was found to be 61/38 with a map of 45, taken on the right upper arm. Patient was immediately placed in the recliner and reclined with legs elevated. Per vaccinating RN, the patient was alert and oriented and speaking clearly when vaccine was administered. Initial Vitals at 1435. Blood pressure:  61/38 map 45 on right upper extremity with adult regular cuff. Pulse: 66; Respirations: 18; O2 saturation: 74% on room air. Patient placed on 15 liters of oxygen via non-rebreather mask. EMS called at 1437. Vital signs at 1438. Blood pressure: 96/56 map 69 on right upper arm with adult cuff. Pulse: 62; Respirations: 18; O2 saturation: 100% on non-rebreather. Clinical response team called, NP at side of recliner assessing patient. Vitals at 1440: Blood pressure: 104/61 right upper extremity with adult cuff. Pulse: 61; Respirations: 18; O2 saturations: 100% on 15 L non-rebreather mask. Vitals at 1442: Blood pressure: 104/59 map 74; Pulse: 59; Respirations: 18; O2 saturations: 100% on non-rebreather mask. EMS arrived to the triage room at 1446. Vitals at 1448: Blood pressure: 107/60 map of 76. On adult cuff right upper extremity. Pulse: 64; Respirations: 18; O2 saturations: 100% on non-rebreather mask. Blood glucose taken: 111. Orders initiated per RN protocol: None, protocol not warranted. Oxygen placed on patient via non-rebreather mask. Patient not wanting to go to the hospital, patient's daughter is on the phone trying to convince him to go to the hospital to be checked out. Patient stating "I just really want to go home." Patient's wife is here as well trying to convince him to go to the hospital. Patient attached to EMS monitors upon arrival at 1446. Vital signs at 1510: Blood pressure 153/80 map 108 on right upper extremity, adult regular cuff. Heart rate: 69; Respiratory rate: 18; O2 saturation level: 99% on room air. Vitals signs sitting at 1516: Blood pressure: adult regular cuff RUE 134/76 map 95; Heart rate: 76. Respirations: 18; O2 saturations: 99% on room air. Vital signs standing: Blood pressure: 156/79 map 104 adult regular cuff on RUE. Heart rate: 76; Respirations: 18; O2 saturations:99% on room air. Patient's daughter, here now at 1520 and speaking with patient and convincing him to go the hospital to be checked out. Patient now at 1531 agreeing to go to the hospital. Patient able to stand and transfer himself to the ambulance gurney. Patient outcome:  Patient transferred via EMS to Hospital at 1534. Patient left vaccine clinic via ambulance at 1534.
12MAR98 pt arm itching, sore, red in PM of same day, hard & hot knot measuring 12cm x 10cm;pt applied ice 24hr then moist warm compresses x 48hr;1wk later arm tender @ deltoid area also hard w/enlarge lymph node under arm;pt exp flu synd
pt came in on 12/9/2021 and indicated he had shoulder pain since the vaccine and hadn't gotten follow up dose because of it.  Pain to lift and lay on that side
Client presented to HD 10/10/2017 with bruising at all stages of development from axillary area and around the arm extending down to approximately 3inches above antecubital area of Left Arm. Bandaid still in place from where influenza vaccine was given 10/5/17. Bandaid removed. Area around injection site clean and dry. No redness noted. Small dot of old blood on bandaid which covered the injection site. Lt Deltoid area swollen and hard. Sl warmer that Rt arm. States when he woke up on 10/6/17 area was very swollen and tender. Believes the swelling to be worse now than when it started.
8.12.08 2pm; VZV, MMR, HepA shots administered; 8.13.00 10am; mom called office to report hives had approved on face last night (8.12.00). Instructed to give Benadryl and call back if ant increased symptoms.
He reacted to the Rotavirus vaccine. He had stomach pain, very severe crying in long episodes and extremely irritable this lasted for 8 days from the vaccine.
Patient has history of multiple sclerosis. Had flareup of symptoms of numbness in extremities starting next day which resolved 5 days after. 11/10/09:  Primary care records received for dates of service 11/2/09 to 11/10/09. Dx:  Leg parasthesia.  Assessment:  Received the seasonal flu shot on 10/28/09, H1N1 vaccine on 10/29/09, given Tami Flu prophylaxis and began feeling leg parasthesia on 10/30/09. Tami Flu stopped 11/3/09.  Symptoms improved significantly by 11/3/09.  At baseline by 11/10/09.
Experience chills during wait period about an hour and a half pain in arm increased numbness and the mobility of. Right arm was difficult to move. employee health applif ice my pain was at a ten level down to a 7 when. I was rent home. I made appt whth doctor for 1/6/21
Dizziness, my arm hurt. Saw the ENT on Thursday, 03/04/2021, for my dizziness. The doctor said there was nothing wrong with my inner ear. I have had a persistent headache, subtle headache after the vaccine.
Pain where shot was given, headache, tiredness, chills, body aches, sore joints, swollen glands.
RUE 21 cm x 17 cm redness over the biceps region with warmth no fluctuance or drainage non tender to touch. Treatment with SEPTRA DS 800-160mg tabs 1 tab bid x 10 days. RTC if no improvement.
About 30 minutes after the vaccination I felt a tingling, numbness sensation in the right side of my back.  As the day went on, the tingly, numbness feeling continued down my right leg.  In the following days, I felt tingling and numbness in both my right and left arms, right and left legs, right and left feet.  I have sense learned this feeling is called paresthesia.  It continued for about 3 weeks on a continual basis.  It is still continuing on an intermittent basis.  Over the last few weeks the feeling moves around from place to place, sometimes feeling it in my arms and hands, sometimes feeling it in my legs and feet.  I have also felt a general lack of energy, fatigue, tiredness.  This began about 1 week after the vaccine and is still continuing now.
L deltoid inflammation with severe fever 101 degrees, swelling and redness. Spoke with pt 7/11/02 and still has sx, no fever. Continues with redness-now to face and jaw.
24 hr after vaccine, developed a rash - transient from one body part to another with white bumps. No fever, saw pediatrician. Reports as allergic reaction to detergent change.
Severe urticaria (hives) 10 days after receiving Moderna COVID-19 booster. Immediate side effects post vaccination were sore arm, chills, fever up to 102 degrees, that started 12 hours after and lasted 36 hours, similar to the second dose. However, 10 days later, constant urticaria all over body, non stop, more pronounced in the evenings and nights, when it doesn't stop. Only thing that controls it is Zyrtec (Benadryl was ineffective), but cannot constantly have antihistamines due to pregnancy (pregnant on Sep 16). Making it extremely difficult, especially with the pregnancy.
A report received from a health care professional on 10/28/2002, concerning a 40 year old female vaccinee who inadvertently received the Fluvirin vaccine subcutaneously on 10/25/2002 and experienced an injection site reaction. On 10/25/2002, the patient complained of warmth, redness and pain at the injection site. On 10/28/2002, the vaccinee stated that the symptoms were relieved, but not completely resolved. The reporter has assessed the relationship of the vaccine to the warmth, redness, and pain as possible, and the inadvertent subcutaneous administration as unclassigied.
Headache, Myalgia, Arthralgia, Fever, FATIGUE Narrative:
Extreme fatigue, chills, headache that would not be helped with 2 Tylenol every four hours. Was unable to leave bed for two days, then had lesser degrees of symptoms for the remainder of a week. Still very fatigued for another week. Also hard lump and rash at injection site for 12 days. Injection site very itchy for two days starting the night of 8/16. No relief except ice pack. Needed ice pack to sleep.
redness at the injection site; itching at the injection site; rash at the injection site; warmth at the injection site; soreness at the injection site; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE ERYTHEMA (redness at the injection site), VACCINATION SITE PRURITUS (itching at the injection site), VACCINATION SITE PAIN (soreness at the injection site), VACCINATION SITE RASH (rash at the injection site) and VACCINATION SITE WARMTH (warmth at the injection site) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     Concomitant products included VITAMINS NOS and OMEPRAZOLE for an unknown indication.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Mar-2021, the patient experienced VACCINATION SITE PAIN (soreness at the injection site). On 10-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (redness at the injection site), VACCINATION SITE PRURITUS (itching at the injection site), VACCINATION SITE RASH (rash at the injection site) and VACCINATION SITE WARMTH (warmth at the injection site). At the time of the report, VACCINATION SITE ERYTHEMA (redness at the injection site), VACCINATION SITE PRURITUS (itching at the injection site), VACCINATION SITE PAIN (soreness at the injection site), VACCINATION SITE RASH (rash at the injection site) and VACCINATION SITE WARMTH (warmth at the injection site) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications also include medication for allergy. No treatment medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 17-Jun-2021: NNI
Soreness in the arm at injection site. Mild fever (101.9), chills, headache, lightheaded, fatigued.  All except the arm soreness resolved completely around 8 hours after onset.
This is a spontaneous report received from a non-contactable consumer (patient). An male patient, of unknown age, received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), on Mar 10, 2021, single dose, for COVID-19 immunisation. The patient's  medical history and concomitant medications not reported. The patient had fatigue/extreme exhaustion, with outcome of unknown. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Fever, body aches, chills, headache, leg cramps, backache. Started 4 hours after injections.
Sever chills and uncontrollable shaking 9 hours after injection (midnight). Symptoms lasted for several house and stopped around 5AM.  Sever headache and fatigue upon waking 8AM and took Tylenol that reduced symptoms. Left arm sourness continued for several days.  No fever throughout.
Vaccine was given greater than 3 hours past the 6 hour window for being left out of the fridge.
left side under my arm and side of my left breast was painful and tender.; left side under my arm and side of my left breast was painful and tender.; could hardly lift my left arm; could feel lumps the size of an egg near my left breast and under left arm as well as inside of left side cavity near my left breast; could feel lumps the size of an egg near my left breast and under left arm as well as inside of left side cavity near my left breast; This is a spontaneous report from a contactable consumer (patient reported for self). A 44-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in left arm on 26Mar2021 (at the age of 44-years-old) as dose 2, single for COVID-19 immunisation. (Reason why batch/lot is Unknown: Not available/provided to reporter at the time of report completion). Medical history included diabetes mellitus from an unknown date and unknown if ongoing; Known allergies: Mucinex DM patient previously took Mucinex DM and experienced drug hypersensitivity. Patient had earlier received first dose of BT162b2 for covid-19 immunisation on 05Mar2021 9:30 (at the age of 44-years-old) on arm left as dose 1, single for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication (other medications the patient received within 2 weeks of vaccination) included Semaglutide (OZEMPIC) shot once a week and Ascorbic Acid (VITAMIIN C) taken for an unspecified indication, start and stop date were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient reported stating on 27Mar2021 09:00 "A day after receiving Pfizer's second dose the left side under my arm and side of my left breast was painful and tender. I could hardly lift my left arm. Left Breast was painful and sore feeling. I could feel lumps the size of an egg near my left breast and under left arm as well as inside of left side cavity near my left breast." The adverse event resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included Left Breast Exam (breast scan): unknown results on an unspecified date in Mar2021. Diagnostic Left Breast Exam was taken as treatment for all the events. Since the vaccination, the patient has not been tested for COVID-19. The outcome of events was recovered with sequelae. Device Date : 19May2021.  Follow-up (16Jul2021): Follow-up attempts completed. No further information expected.
Third dose  of vaccine administered. 1st was on 12/30/20 and 2nd was on 2/9/21 and 3rd on 2/19/21. No adverse affects at this time.
I had my annual mammogram on April 20, 2023.  The mammogram showed a prominent right ancillary lymph node, enlarged from my previous 2022 mammogram and an immediate ultra sound was recommended.  My previous 2022 annual mammogram showed no englarged lymph nodes.  On April 21, I had an ultra sound which showed the right ancillary lymph nodes had 5mm cortical thickening  and the radiologist and my PPC recommended a biopsy.   On May 16 I had a needle  biopsy at a local Medical Center.
NSTEMI and left leg arterial thrombi after first vaccine.  In addition, he is in hospital again now after his second vaccine being evaluated for a second NSTEMI.
This spontaneous report was received from a medical assistant and refers to a 8 week old patient of unknown gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On 04-APR-2016, the patient was vaccinated with an improperly stored dose of ROTATEQ orally, lot # L013202, expiration date: 27-JAN-2017, (dose was not reported). According to the reporter, the vaccines were stored at a temperature of 50.2 degrees Fahrenheit for 9 hours and the temperature excursion took place due to unit adjustment with the door open for stock counting. There was no previous temperature excursion reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Pt received VARIVAX 12/18/12 on 12/26/12 noticed Lt upper outer arm had rash & itching 12/31/12 red bumps not fluid filled on face  & trunk itchy.
Muscle aches, indigestion, gas and bloating, ELEVATED BLOOD PRESSURE and Rapid Pulse
swelling from injection site down to hand with pain and requiring removal of rings except wedding ring that cannot be removed; which normally can be..  I have been taking ibuprofen.  Hand writing on card given out is very poor
Patient under age 18 was vaccinated with Johnson and Johnson which is a vaccine error.  Single vaccine at age 17. Troubleshooting: Scribe and vaccinator did not validate age;  screeners at the beginning of the process did not ask or turn away. Parent validated age as 18. Unreported as error, found in data mining.
About a week after getting my second COVID-19 shot I was not feeling like myself. Knowing now that it turns out I had A-fib it did not feel like I was having a heart attack, or chest pains, I really had ignored it and went to work. I could tell my heart was off though. When I got home from work, I checked my heart rate and my blood pressure and they were both were dangerously high, so I went to the hospital out an abundance of caution. They really could not figure what was going on they admitted me for observation. They did run tests and it did show elevated levels that indicated there was something going on with my heart. I was getting ready to do a stress test and I went into a-fib while they were prepping me for the stress test. That was the same feeling I had when I did not feel like myself and we now know I was having a-fib at that time.  I did end up having an ablation and that led to more testing, and they found blockages in my heart, and I ended up having open heart surgery. This likely saved my life since I was in the hospital when the second a-fib took place, and I was able to learn of the condition of my heart and have the surgeries needed to correct things and get on medication to manage my heart condition.
Pt. came for vaccine. Was given Rotavirus. Needed IPV - mom said pt has rash on legs is irritable. She is 20 wks pregnant.
VACCINE ERROR, ADMINISTERED AFTER AVAILABLE DATE TO BE USED. NOTIFICATION OF PFIZER BIVALENT TO END RECEIVED 9.12.23 LATE AFTERNOON.
Palpitations 4 mins after receiving the vaccine. Vital signs were checked : BP 160/72, Pulse =77, 02 sat =98% Pt was monitored for 30 mins with resolution of her symptoms
pt fainted w/in a minute of administartion of vax brought to w/ammonia ampule; no treatment needed;
extreme pain in arm with injection site, inability to move arm, insomnia due to pain in arm.
While  injecting client with 0.2 ml in left deltoid muscle patient moved unexpectedly causing needle to come out of the arm. The full 0.2 ml was administered but vaccine leakage noted from injection site. Patient was observed. It was escalated to AP hotline and DOH. As per DOH patient is good to go. Patient left observation area in stable condition. AP hotline called and advised to revaccinate client with full dose. Patient father was reached out via phone, he said she will come back tomorrow.
My tongue has been burning, covered in swollen taste buds, and been swollen since the 4th day after the first shot on 24Mar; My tongue has been burning, covered in swollen taste buds, and been swollen since the 4th day after the first shot on 24Mar; My tongue has been burning, covered in swollen taste buds, and been swollen since the 4th day after the first shot on 24Mar; This is a spontaneous report from a contactable consumer or other non hcp. A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 24Mar2021 as single dose, for second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 14Apr2021 as single dose for covid-19 immunization. Medical history and concomitant medications were not reported. It was reported that I want to make you aware of my reaction to the Covid 19 vaccine. My tongue has been burning, covered in swollen taste buds, and been swollen since the 4th day (28Mar2021) after the first shot on 24Mar It started to subside a couple of days before the season shot so my Dr told me to go ahead with the second shot on 14Apr. Again, on Day 4 my tongue went crazy again and remains that way today. I am now in fear of a booster and do not know where to go from here. Treated w/ max doses of Benadryl, steroids, Pepcid. The outcome of the events recovered with sequelae.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
No additional AEs were reported; The health care worker reported that 14 patients received possibly improperly stored vaccines due to lack of temperature readings; This spontaneous information has been received from an other health care professional concerning to a patient of unknown age and gender. The patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications were not reported.  A possible temperature excursion was reported for some vaccines due to the freezer temperature was not recorded since 10-JAN-2022.  On 14-JAN-2022, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ)(dosage regimen not provided) taken orally, lot # 1707593, expiration date 24-MAR-2022, administered as prophylaxis (product storage error). No additional adverse events were reported (no adverse event). The temperature excursion timeframe was reported (since 10-JAN-2022) under an unknown temperature, because since that day the temperatures were not recorded. No previous temperature excursion was reported.  This is one of 14 reports received from the same reporter.; Sender's Comments:  US-009507513-2205USA000553: US-009507513-2205USA000535: US-009507513-2205USA000545: US-009507513-2205USA000484: US-009507513-2205USA000525: US-009507513-2205USA000503: US-009507513-2205USA000524: US-009507513-2205USA000464: US-009507513-2205USA000467: US-009507513-2205USA000533: US-009507513-2205USA000540: US-009507513-2205USA000544: US-009507513-2205USA000564: US-009507513-2205USA000560:
5 mins after receiving vaccines patient reported his throat was "hurting" his neck at skin was red and itchy. He was obsereved in the office for 20 mins and symptoms resolved. Within an hour of recieving the vaccines, when family was back at home, his eyes/ears/lips were swollen, he had widespread hives from head to toe and his body was bright red per mother. Mom took patient to the ED where they administered Benadryl and observed patient for 3 hours. Patient is doing well today.
No PQC or additional AEs reported; Caller reports administration of vaccine after non-supported temperature excursion; This spontaneous report was received from an office manager, referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant therapies and previous drug reactions or allergies was not provided.  On 24-APR-2022, the patient was vaccinated with an improperly stored dose of 0.5 milliliters (ml) of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (formulation, strength, vaccination scheme frequency, route of administration, and anatomical location were not reported; lot number T026168 has been verified to be a valid lot number for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) prefilled syringe, expiration date reported and but upon internal validation established as 04-DEC-2022) as prophylaxis (product storage error).  Since 07-APR-2021, the administered dose of the vaccine experienced intermittently a temperature excursion of 30 degrees Fahrenheit (F) for a time frame of 228 hours, as recorded by a data logger. There was no previous temperature excursion reported. No adverse events were reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. devicelotnumber: T026168; expirationdate: 04-DEC-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability