chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Swelling of lips; Swelling of tongue; Swelling of cheeks; Sore throat; Chills; Fatigue; Muscle pain; Dose received: 3; This is a spontaneous report from a contactable reporter (consumer). The reporter is the patient.  A 49-year-old female patient received BNT162b2 (BNT162B2), administered in arm left, administration date 30Nov2021 at 16:00 (Lot number: EW0176) at the age of 49 years as dose 3 (booster), single for COVID-19 immunisation. The patient had no relevant medical history. Vaccination history included: BNT162b2 (DOSE 2, SINGLE; Lot Number: EN6199; Anatomical site: Left arm; Administration time: 09:00; Route of Administration: Unspecified), administration date: 05Mar2021, when the patient was 48 years old, for COVID-19 immunisation and BNT162b2 (DOSE 1, SINGLE; Lot number: EN6201; Anatomical site: Right arm; Administration time: 09:00; Route of Administration: Unspecified), administration date: 11Feb2021, when the patient was 48 years old, for COVID-19 immunisation. The following information was reported: IMMUNISATION (non-serious) with onset 30Nov2021 at 16:00, outcome "unknown", described as "Dose received: 3"; LIP SWELLING (non-serious) with onset 01Dec2021 at 02:30, outcome "recovered" (an unknown date in Dec2021), described as "Swelling of lips"; SWOLLEN TONGUE (non-serious) with onset 01Dec2021 at 02:30, outcome "recovered" (an unknown date in Dec2021), described as "Swelling of tongue"; SWELLING FACE (non-serious) with onset 01Dec2021 at 02:30, outcome "recovered" (an unknown date in Dec2021), described as "Swelling of cheeks"; OROPHARYNGEAL PAIN (non-serious) with onset 01Dec2021 at 02:30, outcome "recovered" (an unknown date in Dec2021), described as "Sore throat"; CHILLS (non-serious) with onset 01Dec2021 at 02:30, outcome "recovered" (an unknown date in Dec2021), described as "Chills"; FATIGUE (non-serious) with onset 01Dec2021 at 02:30, outcome "recovered" (an unknown date in Dec2021), described as "Fatigue"; MYALGIA (non-serious) with onset 01Dec2021 at 02:30, outcome "recovered" (an unknown date in Dec2021), described as "Muscle pain". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of lip swelling, swollen tongue, swelling face, oropharyngeal pain, chills, fatigue and myalgia.  Additional information: The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient did not receive any medication within two weeks of vaccination. Since the vaccination, the patient had been tested for COVID-19. The events did not result in doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care.
Pronounced erythema at injection site 10 x 10cm 48hours after injection (left deltoid).
chronic hives (urticaria) have occurred full body, found everywhere with the exception of my face and feet.
Headache; Tired; This is a spontaneous report from a Pfizer  A contactable consumer (patient's wife).   A male patient of an unspecified age received both doses of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as SINGLE DOSE, for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Other products were not reported. Caller reported that her husband, the patient, took both doses of the Covid-19 vaccine with very minimal, usual side effects. Caller declined to complete safety report. Caller reported that the patient experienced just the usual, expected side effects. Caller reported that the on unspecified date the patient had a headache and was just tired. The outcome of the event was reported as unknown.  Information on the lot/batch number has been requested. Further Information is expected.
Vaccine stored under refrigeration beyond 30 days. Moderna case ID CEA-2628: lot number 056m21a maintained the activity neccessary to protect against the SARSCoV-2 (COVID-19) virus at time of administration. Did not contact patient per no action required.
11 Doses administered after 30-day Use By Date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (11 Doses administered after 30-day Use By Date) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Jan-2022, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (11 Doses administered after 30-day Use By Date). On 05-Jan-2022, EXPIRED PRODUCT ADMINISTERED (11 Doses administered after 30-day Use By Date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Moderna vaccine put out of the freezer on 01-Dec-2021 and placed in the refrigerator, so it was not supposed to be used beyond 31-Dec-2021.  No concomitant medications were provided.  No treatment medications were provided.
pt with abdominal pain and distention x 1 wk; saw PCP; was sent to ED for evaluation; renal insufficiency and sepsis; found to be positive for COVID; high concern for metastatic pancreaticobiliary malignancy with carcinomatosis and liver metastasis with ascites; pt went into cardiac arrest without ROSC and expired in the hospital
Patient complained of tingling of tip of tongue and palpitations. 5:52 132/90 HR 99 RR20 SpO2 99% 6:00  122/86 HR 88 RR20  SpO2 99% 6:00 Benadryl 25 mg given by mouth, patient stated relief after 5 minutes, no SOB, no c/o of chest tightness, no swelling noted prior to medication administration, lungs clear to auscultation.
Approximately 11 hours after vaccination booster (½ dose compared to first and second vaccines) experienced severe muscle contractions/spasms/twitching over entire body. Symptoms lasted about one hour and only relieved by full body stretching. However symptoms resumed as soon as stretching was stopped. First and second vaccines were accompanied by arm soreness and malaise, which stopped after 24 hours.
6 and a half days later felt very dizzy, and today on march 8, I'm still dizzy. Feels like a light case of vertigo.
COVID infection one month PTA, discharged on home O2. Currently with COVID infection, resp failure with bacterial pna, Afib with RVR. Fully vaccinated. HFNC, steroids, zinc, vit-c. Severe sepsis 2/2 E coli. Documented as "improving". Patient doesn't want to go to SNF or LTAC She has 24/7 care. Will need repeat PT eval. She is very eager to be discharged She will need Home with HHC ongoing PT
itch/Following the 3rd one the itch in her arm came back after it had gone away and itched some more.; sore arm; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PRURITUS (itch/Following the 3rd one the itch in her arm came back after it had gone away and itched some more.) and PAIN IN EXTREMITY (sore arm) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014F21A, 031A21A and 027B21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced VACCINATION SITE PRURITUS (itch/Following the 3rd one the itch in her arm came back after it had gone away and itched some more.) and PAIN IN EXTREMITY (sore arm). At the time of the report, VACCINATION SITE PRURITUS (itch/Following the 3rd one the itch in her arm came back after it had gone away and itched some more.) and PAIN IN EXTREMITY (sore arm) outcome was unknown.            No concomitant medication information provided. Patient age was 63 years 8 months. No treatment information provided.   This case was linked to MOD-2022-654750 (Patient Link).
I BEGAN HAVING FLU LIKE SYMPTOMS INCLUDING FEVER, HEADACHES, BODY ACHES, JOINT PAIN, VOMITING, EYE PAIN. I ALSO HAD A "BB" SIZED BUMP IN MY RIGHT ARM (SITE OF ANTHRAX SHOT). THE BUMP IN MY ARM HAS GONE AWAY BUT I AM CURRENTLY STILL FEELING ILL (08/01/2017).
shingles rash; rash on back/ Patchy rash/ rash on rib cage/ rash on forearms, her elbows, and her shins; red blisters; blisters/ blister oozing; scaly rash; poison ivy rash; itchy rash; very unpleasant; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th November 2019, the patient received the 1st dose of Shingrix (intramuscular). On 9th November 2019, 3 days after receiving Shingrix, the patient experienced shingles, rash, red rash, blistery rash, rash scaly, poison ivy rash, itchy rash and feeling unwell. On an unknown date, the outcome of the shingles, rash, red rash, blistery rash, rash scaly and feeling unwell were recovering/resolving and the outcome of the poison ivy rash was unknown and the outcome of the itchy rash was not recovered/not resolved.   It was unknown if the reporter considered the shingles, rash, red rash, blistery rash, rash scaly, poison ivy rash, itchy rash and feeling unwell to be related to Shingrix.  Additional details were provided as follows: The patient noticed that she had a rash on her back. The rash was a group of red blisters. Then she noticed that more patches of this rash began to show up lower on her back near the sacrum. Then a patch developed on the front of her chest on her rib cage on both sides, on both forearms, her elbows, and her shins. She said that some of the blisters oozed. In some areas the rash area had become red and scaly, in others its a collection of sores almost like poison ivy. It was very unpleasant  She had intense itching on these patches, especially between 3 am and 4 am during the night. Some patches were starting to fade but she still had the intense itching. She stated that she went to see her physician on Monday, 11th November 2019. she went to her physician for routine physical and she showed the rashes to her. She did not feel that it was anything for the reporter to be concerned about and said it could be from the vaccine or from something else. Did not consent to follow up.
at around 9:30 pm I went to the kitchen to get a drink and I began to experience hallucinations of large bugs coming out from under my stove towards me. I quickly got a broom to prove to myself that they were not real. I dropped my can of soda and it sprayed all over the kitchen causing me to fall. I still saw the bugs coming at me and I still had to convince myself that they were not real. I then proceeded to get another can of soda and fix my drink and the foam in the glass turned into a kaleidoscope of clowns. I have never in my whole life ever hallucinated and it was a very scary thing to have happen to me. I figured the best thing to do was go to sleep so I took my sleeping pills and tried to keep my eyes closed till i went to sleep. I slept all through the next day and when I woke at 5 am on the 22nd I was fine.
This spontaneous report as received from a nurse refers to a 18 years and 2 months old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 25-NOV-2015, the patient was vaccinated with an adult dose of VAQTA 50/1.0 U/ML (route of administration, lot # and expiration date were not reported). No adverse effect was reported. Additional information has been requested.
she got her period again JUL 9-13, 2021 and again AUGUST 25, 2021; period MAY 20-24,2021 however, she did not get her period in the month of JUNE, 2021.  She then reported that she got her period again JUL 9-13; This spontaneous case was reported by a consumer and describes the occurrence of MENSTRUATION DELAYED (period MAY 20-24,2021 however, she did not get her period in the month of JUNE, 2021.  She then reported that she got her period again JUL 9-13) and MENSTRUATION IRREGULAR (she got her period again JUL 9-13, 2021 and again AUGUST 25, 2021) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 02HC27A and 626B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In June 2021, the patient experienced MENSTRUATION DELAYED (period MAY 20-24,2021 however, she did not get her period in the month of JUNE, 2021.  She then reported that she got her period again JUL 9-13). On 09-Jul-2021, the patient experienced MENSTRUATION IRREGULAR (she got her period again JUL 9-13, 2021 and again AUGUST 25, 2021). At the time of the report, MENSTRUATION DELAYED (period MAY 20-24,2021 however, she did not get her period in the month of JUNE, 2021.  She then reported that she got her period again JUL 9-13) and MENSTRUATION IRREGULAR (she got her period again JUL 9-13, 2021 and again AUGUST 25, 2021) outcome was unknown.            Concomitant medications were not reported. Treatment medications were not reported.
Noticeable increase in chest pain and discomfort as well as noticeable increase in breathing problems.
Patient received 2.5ml of Moderna COVID-19 vaccine instead of 0.25ml for booster dose.  Patient waited 15 minutes then left with no adverse events.  It was realized after he left what had taken place.
Information has been received from a healthcare worker concerning a 6 year old female patient with no pertinent medical history who on 05/27/1999 was vaccinated with varicella virus vaccine live (Oka/Merck).  There was no concomitant medication.  The healthcare worker reported that the patient was vaccinated at another location.  On 04/19/2004 the patient broke out in a rash and sought medical attention on 04/20/2004.  It was noted that the physician diagnosed the patient with varicella and prescribed the following treatments, calamine, camphor, pramoxine hydrochloride bath, acetaminophen and diphenhydramine.  The patient is still recovering at the time of this report.  No additional information was provided.  Additional information has been requested.
Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-May-2021, the patient experienced DIARRHOEA (Diarrhea). At the time of the report, DIARRHOEA (Diarrhea) had not resolved.            Concomitant medication list was not provided. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not applicable.   Reporter did not allow further contact
I was having headaches which was more like a migraine. I had sensitivity to light and blurred vision. My estimated date of delivery is 11/10/2021.
strong headache; Mild tiredness; chest pain like nerve pain around heart area but I could breathe and no left arm pain; mild nausea; arm pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Feb2023 at 10:30 as dose 5 (booster), single (Lot number: GL0447), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroid" (unspecified if ongoing), notes: Other medical history: Hypothyroid. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE; MANUFACTURER UNKNOWN, Mild tiredness, not as bad as with previous covid vaccines), for Covid-19 immunization, reaction(s): "tiredness"; Covid-19 vaccine (DOSE 2, SINGLE; MANUFACTURER UNKNOWN, Mild tiredness, not as bad as with previous covid vaccines), for Covid-19 immunization, reaction(s): "tiredness"; Covid-19 vaccine (DOSE 3, SINGLE; MANUFACTURER UNKNOWN, Mild tiredness, not as bad as with previous covid vaccines), for Covid-19 immunization, reaction(s): "tiredness"; Covid-19 vaccine (DOSE 4, SINGLE; MANUFACTURER UNKNOWN, Mild tiredness, not as bad as with previous covid vaccines), for Covid-19 immunization, reaction(s): "tiredness".  The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 21Feb2023 at 15:30, outcome "recovered" (Feb2023), described as "arm pain"; CHEST PAIN (non-serious) with onset 21Feb2023 at 16:00, outcome "recovered" (2023), described as "chest pain like nerve pain around heart area but I could breathe and no left arm pain"; NAUSEA (non-serious) with onset 21Feb2023 at 16:00, outcome "recovered" (2023), described as "mild nausea"; FATIGUE (non-serious) with onset 21Feb2023 at 20:30, outcome "recovered" (2023), described as "Mild tiredness"; HEADACHE (non-serious) with onset 21Feb2023 at 20:30, outcome "recovered" (Feb2023), described as "strong headache". Therapeutic measures were not taken as a result of vaccination site pain, chest pain, nausea, fatigue. Therapeutic measures were taken as a result of headache.  Additional information: The patient had no known allergies. The patient did not had covid prior vaccination. Facility type vaccine was reported as Pharmacy or Drug Store. 5 Hrs. after vaccination, the patient - arm pain started it got worse in the next 12 hours but then subsided and gone in 36 hours. 10 hrs. after - strong headache started and lasted about 24 hours but Tylenol helped. Also, chest pain like nerve pain around heart area but I could breathe and no left arm pain. This sensation lasted about 24 hours, but it was intermittent and mild. Mild nausea when headache. 10 hours after - Mild tiredness, not as bad as with previous covid vaccines. The patient was not on any other vaccine in four weeks. The patient had not received any other vaccine on same date of vaccination on 21Feb2023. The patient was not tested for covid tested post vaccination.
Diarrhea, started the night of shot continued till just after 11 pm and restarting the next morning every 20 to 30 minutes until 2 pm.  Also had headache and didn?t feel good.
feeling weak on 11 Apr a day after having the second shot; with the second one that she had blurred vision; the vaccine did something to her nervous system like shaking that she took it and for over 2 hours had chills. Later clarified that these side effects were from the second one; the vaccine did something to her nervous system like shaking that she took it and for over 2 hours had chills. Later clarified that these side effects were from the second one; woke up at 12:45 in the morning shaking and freezing for 2.5 hours and calmed down; This is a spontaneous report received from a contactable consumer (Patient). A 76-year-old patient of an unspecified gender received second dose BNT162B2 (Solution for injection) via an unspecified route of administration on 10Apr2021 at single dose for COVID-19 immunization. Patient medical history and concomitant medications were not reported. It was stated that she wanted to report her side effects from the Pfizer Covid vaccine. Stated that she had Covid in December. Stated that that the vaccine did something to her nervous system like shaking that she took it and for over 2 hours had chills on an unspecified date in Apr2021. Later clarified that these side effects were from the second one. Stated that the pharmacist told her if she had antibodies not to get the shot. Stated she had it checked and had antibodies left. Stated that she had asked her doctor if she should get the vaccine since it was past 90 days since she had Covid and he stated yes. Stated that she took the first one. Stated she did not feel good the next day. Stated that it was like she had Covid, weak and had some shakes two days after. Stated that with the second one that she had blurred vision and woke up at 12:45 in the morning shaking and freezing for 2.5 hours and calmed down on an unspecified date in Apr2021. Stated that in the afternoon that she had another spell of this. Stated that she just felt better today. Stated that she had heard others that had Covid and then had reports of them getting sick. No further details provided. Declined to complete a report about the others. Stated that Pfizer should know that people should not take the vaccine if they have antibodies. Stated that her hair started coming out before the vaccine. Clarified that she had her antibodies checked three weeks before she had first shot. Stated that that one pharmacist stated not to have it until summer and then another stated to go ahead and take it. Stated that she had back and hip trouble and cannot get up the stairs good before the vaccine. Stated that the vaccine is supposed to protect you but who knows. Stated initially that she began feeling weak on 11Apr2021 a day after having the second shot. Stated that it had improved. Later clarified that she was weak from having Covid back in December prior to the vaccine. On an unspecified date in Apr2021, stated that the blurred vision lasted for 15 minutes. Outcome of events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Patient states abd. rash (non-raised reddened area) started about six hours post vaccine. No other symptoms. Patient at home when symptoms started. Patient self-medicated with ZYRTEC. Patient states no symptoms on 10/18/09 when reported to RH.
This is a 73 Y/O female here S/P Pneumonia vaccines PNEUMOVAX-23 4 days ago, she is c/o pain on the injection site (right deltoid) all the way to the neck only right side, redness and swelling, the second day it was bad, unable to move right upper extremity, unable to sleep in that side, took ADVIL, the 3rd day is much better and today is much better than yesterday, initially the pain is 10/10, now pain is 5/10, patient denies systemic symptoms, denies SOB, denies tachycardia.
Afib; Developed heart flutter; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative.  A 52-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: ATRIAL FIBRILLATION (medically significant), outcome "unknown", described as "Afib"; CARDIAC FLUTTER (medically significant), outcome "unknown", described as "Developed heart flutter". The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the events and the suspect drug cannot be excluded. The case will be reassessed once new information is available.  The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.