chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Staff RN was observing the above mentioned person and noted she was having splotchy looking non raised  reddish rash  on arms and neck area. I also  noted she had it on her upper neck & back area. She was given 25mg  of benadryl PO. She denied shortness of breath, throat swelling, difficulty swallowing or itching at this time.  She also denied any other symptoms.  She was verbalizing well and denied any allergies prior to taking her benadryl or vaccine. (Our observation room had equipment and medical emergency box available . Our ED is available also if needed) She was observed for about 1 hour. She did not have any continuation of rash or new symptoms.  Fact Sheet for  COVID vaccine already given &V-Safe.
Three men in their mid-80s, of whom I am one, developed rheumatoid arthritis within 2 months of getting the second vaccination. We live in different parts of the country, but all got the arthritis within the same kind of time period.
In spite of hx of anaphylaxis to eggs, the patient said he had a flu shot in 2020 without incident and requested the flu shot today. Nurse texted patient back 15 minutes after injection and he reported  a rash at the site and "slight tingling in my throat". Nurse offered to give him some Benadryl, but pt. refused. Nurse advised to have his flu shot in doctor's office next year.
NAUSEA; FATIGUE; This spontaneous report received from a patient concerned a 59 year old of unspecified sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 in left deltoid for prophylactic vaccination. No concomitant medications were reported.  On 13-MAR-2021, the subject experienced nausea. On 13-MAR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from nausea, and fatigue. This report was non-serious.
09/18/22 presents to ED for "shortness of breath, weakness-generalized". PMHx of "HIV"
General aches, chills, shaking, facial edema, eyes red and injected with white mucus coming from the eyes, dry coughing, sorethroat, headache.
pt recvd vax 4DEC95 & exp papular morbilliform rash UE 7DEC95 itchy
Chief Complaint:  resp distress, lethargy   Source of Information:  Patient and Available medical record   History of Present Illness:  This is a 35y.o. male    per ems " pt called us for DIB, when we arrived pt was unresponsive , narcan was given, pt lost pulses for a few minutes CPR was started pt regained consciousness. bloody vomited was found in toilet. Patient at that time regained consciousness with hematemesis. Mentation improved after bag valve masking the patient. Narcan was also given for possible overdose, but patient did not seem to have any improvement after.   At time of exam patient is still sleepy although more arousable than previously.  He is in the ICU.  Remains on an insulin drip.  No specific complaint identified although remains sleepy He was started on empiric antibiotic therapy. He required transient vasopressor support which is now been weaned.  He was also found to have acute kidney injury with creatinine 6.8.  Initial lactic acid was 21.5 troponin was elevated.   He was previously triaged in the emergency 1/15/2022, brought in by EMS with abdominal pain and shortness of breath after binge drinking for 5 days whiskey.  He left AMA. He tested positive for COVID on 1/16/2022
Headache, nausea, chills, throwing up, fatigue.  Headache woke me up at 5:30 AM.   Nausea, chills, and throwing up occurred around 7:30 AM.  Chills and fatigue persisted until about 6:00 PM.  I still have a slight headache as of now, 8:00 PM.
"a good amount" of swelling in his arm after the injection; This is a spontaneous report from a non-contactable consumer (the patient) via a company representative. A 54-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number not provided), via an unspecified route of administration in the arm on an unspecified date as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient had "a good amount" of swelling in his arm the day after his first injection. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's relevant medical history, drug reactions/allergies and concomitant medication were not reported. The medical assistant reported that on 18-DEC-2017 the patient received an improperly stored dose of GARDASIL 9 lot number: N017697 (expiration date: 21-JAN-2020), for prophylaxis (strength, route, dose or units were not provided). There was digital data logger involved. The storage characteristics were the following: - Temperature: 47 F to 77 F for 30 minutes. - Previous temperature excursion: at or above 32 F to 35 F for 7 hours. No adverse effects were reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1801USA005371: US-009507513-1801USA005372: US-009507513-1801USA005373:
18 y/o F w/ nausea, chills/sweets and headache starting at 1800 same day of vaccine was given. pt was given SIQ chit, Tylenol and told to remain home until symptoms resolved. current outcome of symptoms is unknown.
Patient had shown me he had sufficient titers for varicella. He was supposed to receive only MMR vaccine, and he was given varicella instead. Error was explained to patient, and was then given the correct vaccine, MMR in the right arm, subcutaneously. Told to follow up with his primary care provider in regards to the error. Patient has not experienced any adverse reaction currently as of 11/14/19.
INAPPROPRIATE AGE AT VACCINE ADMINISTRATION; OFF LABEL USE; This spontaneous report received from a pharmacist concerned a 16 year old female. The patient's weight, height, and medical history were not 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. Per procedure, no follow-up will be  requested for this case. No concomitant medications were reported.  On an unspecified date, the subject experienced inappropriate age at vaccine administration, and off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the inappropriate age at vaccine administration and off label use was not reported. This report was non-serious.
Day /p receiving vax developed swelling (2"diameter), redness & warmth @ site of inject. Cold compresses & Tylenol
COVID-19 Lot # FE3590 Vial PAA165969 Exp 2/22 was placed in the freezer after we received it. It should have been pulled out of the freezer on 10/19/21 at 12:00PM according to the storage guidelines and placed in the refrigerator for 31 days. Our staff did not pull the vial out of the freezer on this date. The staff noticed the date this morning. November 2, 2021 at 08:30.   There were 22 patients who received COVID vaccination during this time frame. The vials were pulled out of the freezer, thawed, and diluted per Instructions during 10/19/21 through November 1, 2021. There are 27 vials that were not used and have been set aside to waste.
Arms, neck, and back of head turned red and itchy, shortly followed by mild shortness of breath
My COVID-19 symptoms started on 01/26/2023 around 8:00PM. I had a runny nose, fatigue, Laryngitis, fever of 101.08, cough, headache, and tiredness. I did a COVID-19 home test on 01/27/2023 which was negative. On 01/28/2023 I did 2 COVID-19 home tests which were positive. After attending a birthday party I was wasn't feeling well so that's when I decided to take the COVID-19 home tests which were positive. On 01/29/2023 I went to the urgent care where they did Flu, COVID-19, and Strep tests. I was negative for Flu and Strep test but I was positive COVID-19. I called my doctor before going to the urgent care. They asked me a lot of questions which I wasn't ready to answer because I wasn't feeling well. They couldn't see me for 2 days. In the urgent care they prescribe me PAXLOVID and over the counter cough depressants. Last night 02/02/2023 I did another COVID-19 home test which was positive again. I just have lingering fatigue, and mild productive cough as of now.
He was having pain in all his joints. We took him to the doctor for X-rays and he was admitted to the hospital for surgery on his left middle finger. It was so swollen they were concerned about the integrity of his finger. He continues to have issue with his lower extremity joint. He was diagnosed with Juvenile Idiopathic Arthritis. He was hospitalized for about two weeks unable to walk. He was prescribed prednisone, PROTONIX, NAPROSYN, and HUMIRA. He is doing better since starting HUMIRA. He still has issues, but he is able to deal with it.
Itching and hives started at 8am on 4/1/21. Both eyelids swelled. Hives on face, neck, chest, arm, stomach and legs. Took 2 Benadryl. Next morning, symptoms were gone.
Nausea, vomiting , cold sweats , throat warm, lethargic fatigue.
This is a spontaneous report from a contactable consumer communicated to a Pfizer sales representative. The patient's wife informed the Sales Representatives wife who informed the Sales Representative. A male patient of an unspecified age received PREVNAR 13, intramuscular on 13Feb2017 at 0.5 ml, single for immunisation.  The patient medical history and concomitant medications were not reported. The patient experienced anaphylactic reaction on 13Feb2017 after receiving the vaccine and went to the ER with outcome of recovered.  The patient was was sent home in the evening.
Patient presents to the ED  with left leg myopathy leading to pain and subjective weakness making it difficult to ambulate
Initial information received on 07-Nov-2018 regarding an unsolicited valid non-serious case received from a Nurse. This case involves a 60 years old patient of unknown gender who received vaccine FLUZONE HIGH DOSE, lot number not reported via unknown route in unknown administration site accidentally. The patient's past medical history and concomitant medication were not provided. It was a case of actual medication error due to accidental overdose and inappropriate age at vaccine administration. It was unknown whether patient experienced any adverse event or not. 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.
HEADACHE; PAIN IN ARM; This spontaneous report received from a parent concerned an 18 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. The batch no was not reported ,The company is unable to performed follow up to request batch /Lot numbers No concomitant medications were reported. On 09-APR-2021, the subject experienced headache. On 09-APR-2021, the subject experienced pain in arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, and pain in arm. This report was non-serious.
left ear swelled up- same side as the injection site; This spontaneous case was reported by a consumer and describes the occurrence of EAR SWELLING (left ear swelled up- same side as the injection site) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     The patient's past medical history included Guillain Barre syndrome.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced EAR SWELLING (left ear swelled up- same side as the injection site). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) for Ear swelling, at an unspecified dose and frequency. At the time of the report, EAR SWELLING (left ear swelled up- same side as the injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.
Client waited first 15 minutes after injection and reports feeling anxious from arm pain.  Client reports pain in right arm after injection.  Reports last injection didn't hurt and today she feels radiating pain into shoulder and neck. Alert and oriented.  Clients skin on neck flushed.  First BP taken 133/73 pulse 93.  Client continued to complain of feeling anxious with increased heart rate from pain.  Client complained injection placed too high in arm.  RN observed injection site placed in appropriate area-right deltoid and without redness.  Pictures taken of injection site. Second BP 128/75 pulse 92. Juice and water offered.  Client referred to PCP to discuss pain medication for comfort. Recommended client apply cool pack to area for comfort and massage neck and shoulder area.  Client observed for another 15 minutes and released after stating she ready to leave.
Sudden Brain Aneurysm on May 11, 2021, Revived and kept alive on machines until taken off life support and subsequently died on May 21, 2021
Fever 100.1 F for 24 hr then 99.6, very fussy for 4-5 days, sudden episode of crying, abd. pain, cramps and constipated. Possible reaction to ROTATEQ.
Red flat "baseball sized" "welt" noted. Painful.  Tylenol given.  Has been at school today.  Inst mom to continue with observation call PCP with increased symptoms.  Mother denies wheezing or diffuculty breathing inst to go to urgent care or ER with these symptoms.  Inst to call with questions or concerns.  Mother verbilizes understanding.  RN
In one week patient went to ER for Abdominal pain . She was evaluated for DVT. Was found to have superficial thrombus on calf
For 48 hours after immunization, patient was bedridden both mentally and physically very weak.  Arm showed bruising and inflammation.
No adverse event; PROQUAD administered after temperature excursion; This spontaneous report was received from a medical assistant and refers to a male patient of unknown age.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 08-SEP-2022, the patient was vaccinated with improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant human albumin (rHA)(PROQUAD) subcutaneous injection, 0.5 milliliter, lot #U028180, expiration date: 08-MAR-2023, administered for prophylaxis (strength, and route of administration were not provided) (Product storage error).  Administered dose of vaccine experienced the temperature excursion of 23.73 degrees Celsius for 28 hours 45 minutes on 24-AUG-2022.  No adverse event reported.  This is one of 2 reports received from the same reporter.
Patient reported redness and soreness at injection site 4 days after injection in addition to some chills. Patient also reported taking ibuprofen for symptoms.
Several weeks after second shot I experienced severe itching, hives and  raised red blotches....After two months of suffering blisters emerged and I was diagnosed with bullous pemphigoid an auto immune disease affecting the skin where the body`s immune system attacks the protein between the top two skin layers.
Within seconds of getting her vaccinations, the patient fell forward out of her chair and hit her head on the floor. Her eyes rolled back and her limbs began twitching. She may have stopped breathing for a few seconds and had bluish discoloration around her face. I (the pediatrician) arrived in the room within seconds, by which time patient was on the exam bed, breathing slowly but comfortably, was bradycardic, and had wet herself. She had normal pupillary response and appeared confused and tired. Over the next several minutes she became more alert and her heart rate normalized. Symptoms were very consistent with a vasovagal reaction in my clinical opinion, of which she has had 2 prior episodes while walking in the past.
Hypotonic, hyporesponsive, pale episode w/in 30 minutes of DTP/OPV/HIB; Returned to nl state w/normal vital signs upon re-arrival @ office w/in 1 hr of vax;
Lump in left breast. Resulting in imaging and consult with breast surgeon. Needle biopsy to follow.  Dr. thinks this is an intramammary lymph node inflammation that has resulted in a lump.
Patient had redness at injection site 4hrs after receiving vaccine on 12/29.  Patient started having red, indurated area around vaccine site on 1/2/2021.  Site around vaccine injection is now red, indurated, firm, and about 2in across.
Hives "everywhere" noted approximately 1 week after immunization with HPV #1. Small area of hives reported 1 1/2-2 weeks after immunization with HPV #2. Benadryl po used with effect.
passed out completely for 15 minutes; fell backwards for about 15 minutes and was fine; sore arm; lethargic; little bit of chill every now and then; low grade fever; felt like he was about to see stars; felt chills up the back of his neck; A spontaneous report was received from a consumer concerning a 49-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events sore arm, lethargic, little bit of chill every now and then, low grade fever, felt like he was about to see stars, passed out completely for 15 minutes, felt chills up the back of his neck, fell backwards for about 15 minutes and was fine.  The patient's medical history was not provided. Concomitant medications reported were Singulair, Zyrtec, Rhinocort nasal spray for drug use for unknown indication.  On 8 Mar 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 003A21A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event sore arm, lethargic, little bit of chill every now and then, low grade fever, felt like he was about to see stars, passed out completely for 15 minutes, felt chills up the back of his neck, fell backwards for about 15 minutes and was fine.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event, sore arm, lethargic, little bit of chill every now and then, low grade fever, felt like he was about to see stars, passed out completely for 15 minutes, felt chills up the back of his neck, fell backwards for about 15 minutes and was fine was unknown.; 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.
SOB,cough, Chest pain, body ache, R shoulder ache  comes in today first time since reaction 11am  11-11-05
Pt recvd 1st dose of vax on 5AUG92; 19AUG92 devel urticaria on trunk & arms which was induced by exposure to heat & coldness; 20AUG92 seen by MD treated w/med;
Pt recv vax on 4/13/99; on 4/14/99 pt exp red/ swollen/ lump/ warm area; tx=antibiotics
covid arm; red rash; dizziness; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE REACTION (covid arm), RASH ERYTHEMATOUS (red rash) and DIZZINESS (dizziness) 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.    In March 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (covid arm), RASH ERYTHEMATOUS (red rash) and DIZZINESS (dizziness). At the time of the report, VACCINATION SITE REACTION (covid arm), RASH ERYTHEMATOUS (red rash) and DIZZINESS (dizziness) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
Seizure lasted 1 minute, lethargic for 1hour and 15 minutes. Eyes rolled back, arms were stiff and body shaking during seizure. Seen in ER admitted to hospital. Had temp. spike to 103.0. 3/2/06 Received medical records from ER which revealed patient experienced cough, congestion, rhinitis, fever & was dx: otitis media, hyponatremia, febrile seizure
I had an increase in heart rate about 5 minutes after receiving the shot which lasted for a couple of minutes only.  I have never had a reaction to any vaccination shot.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reaction, allergies and concomitant medications were not reported. On 25-JAN-2018, the patient was vaccinated with a dose of improperly stored PNEUMOVAX 23 pre-filled syringe (dose and route of administration was not reported), (lot # N029303, expiration date: 21-APR-2019) for prophylaxis. It was reported that the vaccine experienced a temperature excursion of 32 degrees Fahrenheit up to 35 degrees Fahrenheit for 6 Hours and below 32 degrees Fahrenheit (30F) for 1 Hour (incorrect product storage). There was no previous temperature excursion. There were no adverse effects reported. There was no product quality complaint reported. It was reported that this case was reported due to a digital data logger.
At 11:30pm (10 hours after receiving the vaccine), I was having chills and could not stop shaking for about 1.5 hours. I struggled sleeping regardless of being tired. This morning I woke up with body aches, tension headache, stomach ache and a 101.4 fever.
Memory problems with me and my husband. Can not remember words and places normally not a problem; This is a spontaneous report from a contactable consumer (spouse). A 72-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: unknown), dose 1 via an unspecified route of administration on 10Feb2021 12:00 PM on Arm Left as dose 1, single; and then BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: unknown), dose 2 via an unspecified route of administration on 13Mar2021 on Arm Left as dose 2, single for covid-19 immunisation. The medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Allergies to medications, food, or other products was Codeine. No prior vaccination done. List of any other medications the patient received within 2 weeks of vaccination reported as yes. Prior to vaccination, was the patient was not diagnosed with COVID. Since the vaccination, the patient was been tested for COVID-19. On an unspecified date in Feb2021. the patient reported, Memory problems with her and her husband. Cannot remember words and places normally not a problem. They were not really concerned but curious if this is in fact due to the vaccines. It appears to have started happening shortly after first vaccine and continued to be worse after the second vaccine. No treatment received for the adverse event. The patient underwent lab tests and procedures which included covid-19 negative on 05Mar2021. The outcome of the event was not recovered.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021318689 similar report from same reporter