chrisvoncsefalvay/vaers-outcomes huggingface dataset:
SUSPECTED COVID-19 INFECTION; SUSPECTED CLINICAL VACCINATION FAILURE; This spontaneous report received from a patient concerned a 5 decade old white female. The patient's height, and weight were not reported. 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 was not reported,1 total administered on 06-APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 24-MAY-2021,the patient had suspected covid-19 infection with lost of taste and smell and headache. On 27-MAY-2021, patient was diagnosed with Covid-19 virus and was not hospitalized. It was unsure whether the patient have taken any medication or not.  On 27-MAY-2021, Laboratory data included: COVID-19 virus test (NR: not provided) POSITIVE. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected clinical vaccination failure and suspected covid-19 infection was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000180990 This case, from the same reporter is linked to 20210554591.; Sender's Comments: V0: 20210554340- Covid-19 vaccine ad26.cov2.s-Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Patient received COVID pfizer vaccine at 0801PM. Patient left after 20 minutes after observation. Patient was travelling with husband at the car when she experienced warm/hot cheeks, flushing and concerned with history of previous reaction. When patient arrived ( approximately 835pm), patient sat down on the chair. The redness started to extend to her neck and it was then decided to place the patient to the stretcher. Vitals signs were done in which the BP was 183/104 and 174/101 (845pm). The redness spreaded to her forehead and neck. Benadryl 50mg PO was then given (847pm). Patient BP was taken again which was 182/122 , pulse 80, RR 24 (855pm). Patient then complained about pressure in her throat, eyes (right eyes slightly swollen ) and face. It was then decided that epinephrine (859PM) be used but unfortunately the trainer box was removed so the epinephrine was not actually given. The BP documented was then 193/112 (0859PM). EMS  was then called as the epinephrine was administered per protocol. EMS arrived (0910 PM) and BP at that time was 230/112, pulse 70. Patient was started with heart monitor and IV. EMS then took her to the Emergency across the street with husband.
Mom states about 7 hrs after receiving vaccines he had two episodes where his body stiffened (extension of arms, legs, back) and his eyes deviated to the left for 3-5 seconds. This happened again 45 seconds later. The episodes lasted a few seconds. After the episodes patient was acting normally. Temp was 100.1 (R) he had TYLENOL 2 hrs prior (given preventatively).
Heart race; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Heart race) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced PALPITATIONS (Heart race). At the time of the report, PALPITATIONS (Heart race) had resolved. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported. Treatment information in response to events was not provided.   This case was linked to MOD-2021-046413 (Patient Link).   Reporter did not allow further contact
Rash on face and neck 02 99% HR 74 BP 124/82 Stayed for extra 15 minutes  Recorded by staff
2-3 hours after vaccination clt reports feeling as though her head was "swelling". Eventually clt had some loss of hearing lightheaded and denied feeling feverish. Sx had fully resolved in 6 hours.
Patient (employee) received 2nd dose of Hep B series. Pt received injection then preceded back to work area. Once at work are experienced rash, nausea, hot flash approximately 10/15 mins after shot. Pt checked into our emergency room.
1-25-13 after 15 min of monitoring post vaccines - observed mild spotty rash on face only (1-2 m papules erythematous scattered sparsely over face). No other areas of body were affected. Lung CTA bilaterally unaffected, breathing unaffected. Exam otherwise unchanged. Mom was instructed to monitor closely & seek medical help if worsening sx. Mom expresses understanding and agrees. 1-30-13 Nurse called mom states rash went away no other sx.
Arm was sore for three days after injection, swollen and red, slight headache-these symptoms went away in three days Day 8 I started experiencing itching at the injection site with a large welt, 3.5" wide, warm to the touch, very itchy-no pain. Have iced the area and I have taken extra Tylenol and Benadryl to help with the reaction. To note: I do have a large tattoo on my arm that is several years old. Just a note in case that is important.
Patient reported swelling of lips and tongue "feeling thick". Patient given diphenhydramine 25mg  oral solution. Symptoms resolved after 15 minutes
MOC called on Friday August 3, describing injection site as swollen and red. Child was not complaining of pain at site. SW RN suggested to follow OTC Benadryl instructions to treat local reaction, as well as, cold compresses as needed.
Severe lumbar/sacral back pain that began approximately 24 hours after vaccination; This is a spontaneous report from a contactable other health professional (patient). A 37-year-old female patient (patient was not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9264) via unspecified route of administered in Left arm on 28Jan2021 at 14:00 PM (at the age of 37-years-old) for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Medical history included asthma. Concomitant medication patient received within 2 weeks of vaccination included levonorgestrel (MIRENA) via Intra-uterine route of administration and multivitamins. On 29Jan2021 at 14:00 PM patient experienced severe lumbar/sacral back pain that began approximately 24 hours after vaccination. The event was considered as non-serious. The most recent COVID-19 vaccine was administered in hospital. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. The adverse event result in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. No treatment was received for the adverse event. The patient received treatment for the adverse event with Diclofenac. Patient had relevant laboratory tests which included 30Jan2021, post vaccination Nasal Swab was done which was negative and COVID test with results negative on an unspecified date in 2021. The patient received diclofenac for the adverse event. The event outcome of recovered with sequelae.
Fever, weakness in the arm where shot was given, when woke up she had difficulty breathing, swollen throat.
mom reports pt began to cry about 1-2hr p/vax;pt cry became very loud inconsolable scream for about 45min;
Presented with SOB and abdominal pain, fatigue and vomiting. Imaging + for left lung consolidation.   hypoxic respiratory failure, Treatment:  steroids, anticoagulation and Remdesivir.  Went into cardiac arrest and expired.
mom noticed a swollen, hot, red area the size of a baseball @ the inj site;brought pt to see MD who treated pt w/cold compresses;
One day after receiving tetanus/diphtheria adult booster, developed fever and flu like symptoms.
I received booster shot on 12/6/2021 and began developing hives/rash on 12/17/2021. I've never had an allergic reaction where I experience hives. I could not identify any other thing that could have caused this.
Rash in diaper blood present after visit for shots but either spread or new rash developed on trunk and URI and fever.
4 days later ears itching, 5th day some hives, 6th day completely covered with hives. Wen to dermatologist, said drug reaction, on steroids. Only medication for many weeks, no new foods, detergents, shampoos.
general body aches; soreness at the site of injection; A spontaneous report was received from a consumer concerning a 71-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events general body aches, soreness at the site of injection.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 3 Mar 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 031M20A) via unknown route for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event(s) general body aches, soreness at the site of injection.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), general body aches, soreness at the site of injection was unknown.
He tested positive for COVID in October, after being vaccinated in early 2020.; He tested positive for COVID in October, after being vaccinated in early 2020.; This is a spontaneous report from a contactable consumer. An adult male patient received the first and second doses of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine via an unspecified route of administration in early 2021 (Batch/Lot number was not reported for neither of the two doses) for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient tested positive for COVID in Oct2021, after being vaccinated in early 2021. Th event resulted in Doctor or other healthcare professional office/clinic visit. The event outcome was resolving at the time of the report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
back pain/she is having shooting pain in the upper back; This is a spontaneous report received from a contactable consumer(patient), self-reported. A 64-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry dates: unknown), via an unspecified route of administration, on 21Apr2021, as single dose for COVID-19 immunisation. Patient medical history included which was spinal stenosis and took ibuprofen, aspirin, or naproxen for back pain. Patient concomitant medication included which was Tylenol. Patient stated Tylenol does not help and wanted to know if can take naproxen or aspirin for the pain. On 21Apr2021 at morning, patient had shooting pain in the upper back, this was new for her. The outcome of the event was unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Patient reported facial tingling about 2 weeks after her Moderna Bivalent vaccination and then it traveled to her shoulder/arm, then body and experienced hot spots and a burning sensation all over her body.  She also has muscle aches in her legs.  She was prescribed Cymbalta by a neurologist which seems to help.
suspected vaccination failure; I've had them; still hurt; This case was reported by a consumer via interactive digital media 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), shingles and pain. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional details were provided as follows: The patient had reported for him/herself. The age at vaccination was not reported. The patient had been vaccinated several times and it did not prevent shingles for him/her. After receiving Shingles vaccine, the patient got shingles four times. The patient had them in January and it still hurt at the time of reporting. The patient stated that, shingles got worsen every time. This case was considered as suspected vaccination failure, since the details regarding the time to onset for event and laboratory confirmation of shingles were not provided.
Patient started out in Immunizations department. Shortly after receiving varicella vaccine patient did not appear well according to staff member patient was then taken to medical assessment department for evaluation where he received epi-pen and Benadryl. Patient was the transferred  to main hospital for further treatment.
First dose of Gardasil on June 2017/Second dose of Gardasil on October 2017/On 2020 the consumer called inquiring for the third dose administration; Consumer inquired if the patient could receive the third dose of Gardasil 9 if the patient was experiencing an "ulcerative colitis flare up"; This spontaneous report was received from a consumer reporting on her daughter, a 21-year-old female patient. The patient's concurrent conditions included colitis ulcerative. Information regarding the patient's pertinent medical history, past drug reactions/allergies, and concomitant medications was not reported.  On an unspecified date in June 2017, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) for prophylaxis (strength, dose, route of administration, anatomical location, lot number and expiration date were not provided).  In October 2017, the patient received the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) for prophylaxis (strength, dose, route of administration, anatomical location, lot number and expiration date were not provided).   On an unspecified date in October 2017, the patient experienced ulcerative colitis flare up. The reporter wanted to know if the patient could receive a third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (inappropriate schedule of product administration).  The outcome of colitis ulcerative was unknown.    The causality between hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) and the event occurrence was not reported.   Upon internal review, the event colitis ulcerative was determined to be medically significant.
10:55am- Patient with complaints of redness and blotching of face and neck areas with minimal itching .  Vitals, B/P 153/99, HR 69, R 20, O2 sat 97%.  Offered rest while observing.  Offered Gatorade and teddy grahams, and water, and all tolerated well. At 11:00am, patient stated she felt better, and vitals now, B/P 159/89, HR 68, R 20, O2 sat 98%. Benadryl not administered since patient is driving.  Redness had diminished slightly to face.  11:20am, Patient released, and advised to call her PCP if symptoms persist, and patient verbalized understanding of instructions.
LITTLE PAIN IN THE ARM; CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a consumer concerned an 80 year old male. The patient's height, and weight were not reported. 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: 1805022, and expiry: Unknown) dose was not reported, 1 total, administered on 11-MAR-2021 for prophylactic vaccination into right arm. No concomitant medications were reported. On an unspecified date, the patient experienced little pain in the arm and that was it. On 17-AUG-2021, the patient's health care professional (HCP) ordered a blood test, an antibodies test (Severe acute respiratory syndrome coronavirus 2 Antibody Immunoglobulin G, Spike, Semi-Quantitative, reported as "SARS COV2 AB IGG SPIKE SEMI QN") which came negative (confirmed immunological vaccine failure). Reporter was concerned that patient was protected against Covid-19 infection or not. The HCP provider recommended taking another dose of COVID-19 vaccine.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the confirmed immunological vaccine failure and pain in the arm was not reported. This report was serious (Other Medically Important Condition). This report was associated with regulatory authority: 90000192053. This case, from the same reporter is linked to 20210905692.; Sender's Comments: V0.20210905663-covid-19 vaccine ad26.cov2.s -Confirmed immunological vaccine failure . This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Patient received third dose of Hep A and Hep B two months early.   Patient will schedule additional vaccine at appointed time.
On the 3rd/4th day AFTER I was vaccinated with Pfiser, I became very swollen all over my body, but ankles and legs, arms and writst, face (not throat) were effected.  I also had a rash on my arms and upper chest area.  I was told to start taking 10 mg a day of prednisone and it has finally cleared up.
After a week, a rash developed at the injection site as well as additional swelling and soreness.
arm is hurting so much; This spontaneous case was reported by a physician and describes the occurrence of PAIN IN EXTREMITY (arm is hurting so much) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high and Cholesterol.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (arm is hurting so much). At the time of the report, PAIN IN EXTREMITY (arm is hurting so much) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications included unspecified high blood pressure and cholesterol medications. No treatment information was provided. Action taken with mRNA-1273 in response to events was not applicable.
4 Nurshing home patients Died; A Spontaneous report was received from a pharmacist concerning  4 nursing home patients of unspecified age and gender who received Moderna's COVID-19 vaccine (mRNA-1273) and died.  The patients' medical histories were not provided. No relevant concomitant medications were reported.   On unspecified dates, 4 nursing home patients received their first of two planned doses of mRNA-1273 (Lot # 039K20A) for prophylaxis of COVID-19 infection. A pharmacist reported that they just learned 4 nursing home patients died after the first dose of the Modern vaccine. The patients were buried, and no autopsies were conducted. The pharmacist suspected latent Covid-19 on the patients and that the vaccine precipitated this outcome. No treatment information was provided.   Action taken with the second dose of mRNA-1273 in response to the event was not applicable.   The event 4 nursing home patients died was fatal.; Reporter's Comments: This case concerns 4 nursing home patients of unspecified age and gender who received their first dose of Moderna's COVID-19 vaccine (mRNA-1273)Lot # 039K20A) and died. Very limited information regarding this event has been provided at this time.  Further information has been requested.; Reported Cause(s) of Death: died
Started three days ago today marks 3. The first day my arm was swollen with a red warm circle and hard. 2nd day was the same but now itchy stopped at a urgent care and they provided me with amoxicillin and Benadryl. Here we are third day and it?s the same issue and it spread out to the sides so now is more like an oval red warm circle.
Approximately five minutes after the patient received his vaccines, he began vomiting, his face became flushed, he became congested and mom reported patient started pulling at his neck. Patient taken to Emergency Room by his mother.
The patient had single dose Janssen on 4/10/21 and then returned and was inadvertently injected with Pfizer
21 year old male Rx to Smallpox vaccine. C/O muscle aches, local itching to site, headache and swollen lymph nodes to right arm pits x 4days. Med: Motrin
Red, spreading, bruised, white marks, itching, sore, still some signs after 1 week - went to Dr on 19th for CELESTONE shot & 2 days of 50 mg x2day for 2 days.
Last year not long after receiving the vaccine I started going from what I can only describe as cow pie bowel movements or the runs. If I eat something that has a bit of grease two days in a row, I will have the runs. No matter what I eat, my bowel movements have a terrible smell to them. The color of my bowel movements is very distinct also, when they are the cow pie, they are very brown, when it's the runs the color is yellow. I finally have an appointment to see a gastroenterologist.
1/2 of the dose was not administered to patient; needle was not properly attached to the syringe; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (1/2 of the dose was not administered to patient) and DEVICE CONNECTION ISSUE (needle was not properly attached to the syringe) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-May-2021, the patient experienced UNDERDOSE (1/2 of the dose was not administered to patient) and DEVICE CONNECTION ISSUE (needle was not properly attached to the syringe). On 14-May-2021, UNDERDOSE (1/2 of the dose was not administered to patient) and DEVICE CONNECTION ISSUE (needle was not properly attached to the syringe) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.
erythematous, raised wheel 3"x 6-7", swollen, tender 24 hrs p/inject; no tx;