chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Shortness of Breath; Asthma; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness of Breath) and ASTHMA (Asthma) 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 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (Shortness of Breath) and ASTHMA (Asthma). At the time of the report, DYSPNOEA (Shortness of Breath) and ASTHMA (Asthma) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported. No treatment information was provided.   Reporter did not allow further contact
Stroke Hospital ER - admitted 12/1 - 12/4 Bilateral field of vision loss right 50% of both eyes
This spontaneous report was received from a nurse supervisor and refers to a patient of unknown age and gender. The patient's relevant medical history, concurrent conditions and concomitant medications were unknown. On 02-AUG-2018, the patient was vaccinated with an expired dose of M-M-R II lot # M034857 and expiration date 27-JUL-2018, for prophylaxis (dose, strength, and route of administration were unknown). The patient experienced no adverse events. The doses were supported per post expiry memo. This is one of 2 cases from the same reporter. Sender's Comments: US-009507513-1808USA003414.
Bilateral shoulder pain and joint pain Loss of smell x 3months TMJ pain x3months facial nerve/burning pain x1 day Tachycardia x2weeks with extreme fatigue Fatigue x 1month Tinnitus/continuous on going from time of 2nd dose to time of writing this Blood spots under finger nails and first toe nails bilaterally abdominal pain x2weeks palpable liver and spleen/hepatosplenomegaly x 1week Confusion/brain fog x4months Difficulty with focusing poor memory/ongoing Frustration/irritability x 3months shortness of breath x 1.5months
Pt has pneumonia vaccine on 10/19/12. Pt went to ED on 10/21/12 after redness/swelling of arm and fever of 103.2.
Patient woke up Saturday morning after receiving the flu shot with her left arm bruised with some redness and an itchy rash that wnt down her entire left arm.
Case number PHEH2014US017091, is an initial spontaneous report received from a nurse on 25 Aug 2014. This report refers to an 18-year-old male patient. Past medical history and concomitant medications were not reported. The patient received only Men CWY liquid conjugate component of MENVEO (batch number: X14024) without reconstitution with Men A lyophilized component intramuscularly on 25 Aug 2014. No adverse event was reported following this medication error.
Pt felt weak in the knees, warm sensation moving up body and tongue swelling.  She was given 50mg of Bendadryl and was observed.  She was offered Benadryl injection and EpiPen but didn't feel she needed it.  She was observed at the pharmacy for at least 45min -1hr.  She felt symptoms were improving and felt ok to walk around the store and then go home.  She was offered a ride or to call roommate but pt said not necessary
Tingling on the Tongue; numbness on lower left half of face; This is a spontaneous report from two contactable consumers. These consumers [patient's husband and 58-year-old female consumer (patient)] reported that she received bnt162b2 (Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number EN6201, Expiration Date: 30Jun2021) via an unspecified route of administration, administered in Arm Right on 10Mar2021 13:15(at the age of 58-years-old) as Dose 1,Single for COVID-19 immunization. The patient's medical history included ongoing type 2 diabetes mellitus Diagnosed 19 years ago. Concomitant medications included insulin (INSULIN),States it is split in to two; for a total of 65 units a day, injection, one morning and one evening. No prior vaccinations (within 4 weeks). Family Medical History Relevant to AE(s) states she has no family medical records because she was adopted. AEs following prior vaccinations includes Arm Soreness from prior annual flu vaccinations. On 10Mar2021 at 13:30 within 15 minutes post vaccination, the patient experienced tingling on the tongue with outcome of recovering, numbness on lower left half of face. Her husband wanted to know if this is normal and what they should do about it. No shortness of breath, no throat swelling. No Emergency Room or Physician Office visit required.The outcome for event tingling on the tongue was recovering and for event numbness on lower left half of face was not recovered.  No follow-up attempts are possible. No further information is expected.
PATIENT WAS AT AT COVID-19 VACCINATION OFFSITE EVENT ON 3/18/2021 TO RECEIVE SECOND DOSE OF COVID VACCINE. PATIENT WAS SCREENED BY PHARMACIST VIA VACCINE AGENCY AND INFORMED CONSENT FORM FOR ACCURACY.  PATIENT RECEIVED FIRST DOSE OF VACCINE WITH NO ISSUES, BUT HAD AN OUTBREAK OF HIVES 20 MINUTES AFTER THE SECOND DOSE ADMINISTRATION. PATIENT WAS ATTENDED TO BY PROVIDERS WHO WERE ONSITE AND ADMINISTERED 50MG OF DIPHENHYDRAMINE LIQUID, AND WITHIN 20-25 MINUTES OF ADMINISTRATION OF DIPHENHYDRAMINE THE HIVES WENT DOWN.  FOLLOW UP CALL WAS MADE BY PPROVIDER 810PM ON 3/18/2021, TO MAKE SURE PATIENT WAS DOING WELL, WHICH HE STATED EVERYTHING WAS FINE AND REACTION STOPPED COMPLETELY.
pulmonary problem; Initial information received on 16-Nov-2020 regarding an unsolicited valid serious social media case from a non-health care professional (patient's wife).   This case is linked to cases 2020SA342066 and 2020SA342079 (same reporter).  This case involves a male patient (age was not reported) who had pulmonary problem (lung disorder), after he received INFLUENZA VACCINE and PNEUMOCOCCAL VACCINE.  The patient's past medical treatment(s), vaccination(s), family history and concomitant medication were not reported.  At the time of the event, the patient had ongoing medical history of diabetes mellitus.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer and a dose of suspect PNEUMOCOCCAL VACCINE not produced by Sanofi Pasteur (batch number and other dosing details were not reported) for prophylactic vaccination.  On an unknown date, the patient developed serious pulmonary problem (lung disorder), (unknown latency) following the administration of INFLUENZA VACCINE and PNEUMOCOCCAL VACCINE. The patient was hospitalized for this event on an unknown date.  Details of laboratory data were not reported.  It was reported that, the patient had to retire early due to this event.  It was not reported if the patient received any corrective treatment.  On an unknown date, 6 months later the patient had recovered from the events.  Information on the batch number was requested.; Sender's Comments: This case concerns a male patient who had lung disorder, after vaccination with INFLUENZA VACCINE (produced by unknown manufacturer) and PNEUMOCOCCAL VACCINE (not produced by Sanofi Pasteur). The time to onset is unknown.  The patient's past vaccination and tolerance, allergic history, concomitant medication and lab tests ruling out alternate etiologies were not reported. Moreover, two different vaccinations preceded the events. Based upon the reported information, the role of an individual vaccine cannot be assessed.
not feeling well; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (not feeling well) in a 66-year-old female patient 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MALAISE (not feeling well). At the time of the report, MALAISE (not feeling well) had resolved.            No relevant concomitant medications were reported. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not applicable.
Itching and rash on arms, neck, head, torso.  Tachycardic.
After vaccine was administered,  patient was asked to wait for 15 minutes, at which time Parent notices that child had passed out, looked pale and unresponsive to name calling. I (pharmacist) was alerted to the event and I and couple technicians went out to assist patient.  I elevated child's feet,  supported head, took blood pressure and pulse. Child regained consciousness and was able to respond to name in less than two minutes. Child stated that he was hot and agreed to drinking cold water. I also applied cold compress to child's forehead and wrists. Child took sips of water and BP was continuously monitored. Parents stated that child looked much better and had regained color to his face. Child was monitored to 30 mins by the pharmacy team with no event before parents took child home.
Patient vaccinated on 1/22.  The next morning (1/23), patient experienced diminished sensory and motor function in left arm and leg, as well as facial numbness.  Presented to the hospital on 1/24, and was found to have a small stroke in pontine medullary junction.  Discharged on 1/25.  There is some suspicion that her COVID infection in December may have precipitated this, and patient is currently being evaluated for coagulation disorders, primarily antiphospholipid antibody testing.  It is unlikely that the vaccine contributed to this, but given close timeline between the two, filing this report.
Severe headache, high fever, fatigue, and sinus drainage 12 hours after vaccination
non-irritating hive/Hives were noticed on arms,  belly, back, face, legs; vomiting; Vaccine location Left leg; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 2-year-old male patient received BNT162b2 (BNT162B2), on 22Jun2022 as dose 1, single (Lot number: FT9142) at the age of 2 years intramuscular, in left leg for covid-19 immunisation. The patient's relevant medical history included: "chronic ear infections" (unspecified if ongoing); "covid" (unspecified if ongoing), notes: Prior vaccination. There were no concomitant medications. The following information was reported: PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (non-serious) with onset 22Jun2022, outcome "unknown", described as "Vaccine location Left leg"; URTICARIA (non-serious) with onset 30Jun2022, outcome "recovering", described as "non-irritating hive/Hives were noticed on arms,  belly, back, face, legs"; VOMITING (non-serious) with onset 30Jun2022, outcome "recovering". The events "non-irritating hive/hives were noticed on arms,  belly, back, face, legs" and "vomiting" required physician office visit. Therapeutic measures were not taken as a result of urticaria, vomiting.  Additional information: No other vaccine in four weeks. No other medication in two weeks. Covid was not tested post vaccination. No known allergies. 8 days post covid vaccine, patient had non-irritating hives that came and went and returned sporadically over 2 days. Hives were noticed on arms, belly, back, face, legs. No other symptoms came along with hives or prior to hives except for 1 instance of vomiting on 30Jun2022 when hives started.  No follow-up attempts are possible. No further information is expected.
Headache, Myalgias, Arthralgia, Fatigue, Chills Narrative:
Patient was given HPV vaccination at age 55 which is not approved for people over the age of 45. No adverse reactions reported by patient.
I felt fever, tired, muscle pain and chills in my body, and I felt pain in left arm over one week. I drank much water and took Muncinex strength medicine for two days. I also used cooler pad to cool down my fever and left arm. The adverse symptoms were less severe than the first dose. After two and half days, I recovered.
Severe muscle ache; Light sensitivity/ The patient was not able to keep her eyes open for the first half of the day; Fever; Chills; Sweats; Feeling the body aches; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 24 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 19Nov2021 19:00 (Batch/Lot number: unknown) at the age of 24 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Endometriosis" (unspecified if ongoing); "PCOS" (unspecified if ongoing); "migraines" (unspecified if ongoing); "Penicillin allergy/amoxicillin allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. , Location of injection: Arm Right, Vaccine Administration Time: 12:00 AM), administration date: 07Apr2021, when the patient was 24 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. , Location of injection: Arm Right, Vaccine Administration Time: 12:00 AM), administration date: 17Mar2021, when the patient was 24 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 19Nov2021 19:00, outcome "unknown", described as "Booster"; MYALGIA (non-serious) with onset 20Nov2021 12:00, outcome "unknown", described as "Severe muscle ache"; PHOTOPHOBIA (non-serious) with onset 20Nov2021 12:00, outcome "unknown", described as "Light sensitivity/ The patient was not able to keep her eyes open for the first half of the day"; PYREXIA (non-serious) with onset 20Nov2021 12:00, outcome "not recovered", described as "Fever"; CHILLS (non-serious) with onset 20Nov2021 12:00, outcome "not recovered", described as "Chills"; HYPERHIDROSIS (non-serious) with onset 20Nov2021 12:00, outcome "not recovered", described as "Sweats"; PAIN (non-serious) with onset 20Nov2021 12:00, outcome "not recovered", described as "Feeling the body aches". Therapeutic measures were not taken as a result of myalgia, photophobia, pyrexia, chills, hyperhidrosis, pain.  Additional information: These event did not result in causing hospitalization and prolongation of hospitalization; life threatening; death; disabling or incapacitating; congenital anomaly or birth defect.  The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed as COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient reported that she experienced severe muscle ache within 24 hrs and light sensitivity and she was not able to keep her eyes open for the first half of the day. This continued until 21Nov2021 (at the time of reporting) and the patient was still feeling the body aches, fever, chills and sweats.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Fever, arm pain Narrative per supervisor report: "received 2nd injection on Wednesday 2/24/21 experiencing left arm pain, and fever."
This spontaneous report as received from a healthcare worker refers to a 6 month old patient of unknown gender. Concurrent conditions and medical history were not reported. On 29-JUN-2015, the patient was vaccinated with improperly stored dose of ROTATEQ (lot # K015816 and expiration date 29-MAR-2016 (dose was not provided). No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Blood in stool, fever, red, peeling feet. High pitched screaming, erratic behavior. Cold with bad congestion. Treatment: antibiotics. Beginning symptoms 1/6/93 through first week of February 1993, but screaming and erratic behavior continued 1 year and longer for behavior. 60 Day follow up: severe autism. Pt held his head in pain for 2-3 yrs after vaccine reaction, he lost speech, behavior has now worsened since he was admitted as a placement for his own good, he almost died from abusive treatment including starving him. We have tried various lawyers suggested by government who gave us run around regarding compensation for injury. We would like Pt home but need financial assistance.  Information recieved from Medical record states headache, otitis, behavior problems, agitation. msv Information from second medical record states self abusing, retareation, autism, allergy reaction. msv
patient came to drive thru requesting Janssen and Janssen vaccine. the patient had not been previously vaccinated with any Covid vaccine. the nurse does not verify the patient and administered pfizer. it was noted afterwards the wrong vaccine was given.  she was in observation for 30 minutes with no adverse reactions or symptoms. she was then let go
Extreme muscle pain. Twisting and tightening feeling. Unable to relax. swelling at injection site and bruising
pt had 10 minute generalized sz w/gradually resolved; todd's paralysis 19JUN92; adm to hosp for observation; CT neg;
Blisters on nose (inside some and all around nostrils on outside), sores on roof of mouth, tongue, and on some gums. Very thick post nasal drip, yet dry parts when blow nose, with some blood.  Using Abreva and saline spray.
Broke out in rash of red spots all over the body. I could not feel the bumps though.
Pt. started itch on palms and soles of feet, progressed to scalp and torso; took BENADRYL about 12:00/13:00-itching improved. Itching returns without BENADRYL. Pt. states condition is "much better."
The MMR vaccine was expired.  The expiration date was 9/1/2022, the vaccine was given 10/3/2022. Patient did not experience any adverse reactions or symptoms after receiving the vaccine.
Sweating; Chills; Fever (100°F); This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Sweating), CHILLS (Chills) and PYREXIA (Fever (100°F)) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced HYPERHIDROSIS (Sweating), CHILLS (Chills) and PYREXIA (Fever (100°F)). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, HYPERHIDROSIS (Sweating), CHILLS (Chills) and PYREXIA (Fever (100°F)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medication provided.
This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore Throat), RHINORRHOEA (Runny Nose) and COUGH (Cough) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced OROPHARYNGEAL PAIN (Sore Throat), RHINORRHOEA (Runny Nose) and COUGH (Cough). At the time of the report, OROPHARYNGEAL PAIN (Sore Throat), RHINORRHOEA (Runny Nose) and COUGH (Cough) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported. No Treatments were reported
COVID-19 confirmed by positive COVID-19 test; COVID-19 confirmed by positive COVID-19 test; This is a spontaneous report from a contactable Health Care Professional (patient).    A 21-year-old non-pregnant female patient received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. EL0142) at single dose, in the left arm, on 01Jan2021 at 09:00 PM, for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Relevant medical history was unknown. Concomitant medications included levocetirizine. On 12Jan2021, after receiving first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine) the patient resulted positive to COVID-19. Post the vaccination, the patient has been tested for COVID-19 on 12Jan2021 and resulted positive. COVID-19 test type post vaccination: Nasal Swab (COVID-19 PCR test). No treatment received. Clinical outcome was unknown at time of this report.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 cannot be excluded for reported events.
Information has been received from a nurse concerning a 62 year old female with an allergy to BENADRYL who on 16-JUL-2007 was vaccinated intramuscularly in the right deltoid, with a first dose of Zostavax (Oka/Merck) (Lot#657765/0585U). The patient developed a "fever of 101 degrees" days after receiving the vaccination. Unspecified medical attention was sought. There was no other information provided. There was no product quality complaint involved. Follow up information indicated that the patient began running a low grade fever on the night of vaccination. (previously reported as days after vaccination) the patient had a maximum fever of 101.9 degrees Fahrenheit. The fever persisted for several days until the patient was seen in the office on 26-JUL-2007. Her temperature was 101.2 degrees that morning, but after being treated with TYLENOL in the office her temperature dropped to 98.6 degrees. Urinalysis, unspecified labs and chest x-ray taken in the emergency room were all negative. Additional information has been requested. 12/21/07 This is in follow-up to report(s) previously submitted on 9/24/2007. Follow up information received from the nurse indicated that Epstein Barr IGG and IGM studies were positive, but there was the possibility of cross-reactivity with the varicella zoster antibodies. Other lab studies of alkaline phosphatase, ALT< and AST were improving. The transaminitis was normalizing. The patient had a liver sonogram which was consistent with steatosis. Also noted in the study was a 2.2x2.2x2.3 cm right renal nodule. The patient had a CAT scan of the right kidney which revealed a 2-cm apparent angiomyolipoma. There was no illness at the time of vaccination. Additional information is not expected.
Experience strong body itching not an injection site.  Itching occurred in many different body areas such as back, stomach, legs, top of feet, buttocks etc.  Itching last for 20-30 minutes then resolves.  Occurs later at another area.  Some redness and small bumps in area of itching.
rash; This is a spontaneous report from a non-contactable consumer (patient). An adult female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown if the patient was diagnosed with COVID-19 prior to vaccination. It was unknown if the patient has been tested for COVID-19 since the vaccination. The patient experienced rash on Jan2021. It was unknown if treatment was received for the adverse event. Clinical outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.