chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fell over/fainted soon after 1st injection of Pfizer in lt arm from sitting in chair. Mother and nurse supported his fall. No injuries sustained. Reported of h/o syncope/fainting from all or after every medical related procedures. Vitals WNL. Sweaty and pale appearance. Colors returned after sips of gatorade.
Breakthrough case admission after 2 vaccines Moderna 2/11/21 Lot# 037K20A;  Moderna 3/9/21 Lot# 027L20A
Swollen shoulder; Swollen arm; Headache; Fever; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Swollen shoulder), PERIPHERAL SWELLING (Swollen arm), HEADACHE (Headache) and PYREXIA (Fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced SWELLING (Swollen shoulder), PERIPHERAL SWELLING (Swollen arm), HEADACHE (Headache) and PYREXIA (Fever). At the time of the report, SWELLING (Swollen shoulder), PERIPHERAL SWELLING (Swollen arm), HEADACHE (Headache) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
Vials that was put in the fridge and after that refrozen and thawed again for adult male patient; No adverse event; Bivalent booster was given yesterday from vials that was put in the fridge and after that refrozen and thawed again; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Bivalent booster was given yesterday from vials that was put in the fridge and after that refrozen and thawed again), PRODUCT STORAGE ERROR (Vials that was put in the fridge and after that refrozen and thawed again for adult male patient) and NO ADVERSE EVENT (No adverse event) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 11-Jan-2023, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Bivalent booster was given yesterday from vials that was put in the fridge and after that refrozen and thawed again). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vials that was put in the fridge and after that refrozen and thawed again for adult male patient) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Bivalent booster was given yesterday from vials that was put in the fridge and after that refrozen and thawed again), PRODUCT STORAGE ERROR (Vials that was put in the fridge and after that refrozen and thawed again for adult male patient) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Bivalent booster was given yesterday from vials that was put in the fridge and after that refrozen and thawed again) and PRODUCT STORAGE ERROR (Vials that was put in the fridge and after that refrozen and thawed again for adult male patient).    This case is for 42th  patient out of 100 patient's case. Concomitant product use was not provided by the reporter. Patient received additional booster dose. 100 male patients were received bivalent booster dose. Moderna COVID19 vaccine bivalent, dosage given was in ml but was unknown to the healthcare practitioner. Also, lot number was unknown to the healthcare practitioner. Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-697752 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-697752:Master case
Joint pains and aches isolated in patient?s feet. Began about 4pm and lasted at least until patient went to bed.
Covid-19 positive test after the 1st dose; This spontaneous case was reported by a health care professional and describes the occurrence of SARS-COV-2 TEST POSITIVE (Covid-19 positive test after the 1st dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Mar-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 SARS-COV-2 TEST POSITIVE (Covid-19 positive test after the 1st dose). At the time of the report, SARS-COV-2 TEST POSITIVE (Covid-19 positive test after the 1st dose) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment medications were unknown.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 21-Jun-2021: Follow-up received on 22-JUN-2021. No New Information was provided.
About half an hour after receiving 2nd dose, I started to feel a little nauseous and my throat felt like it was tightening a bit. It was nothing too major, but I did call paramedics to monitor me. The episode subsided about a half hour after that.  However, I did have a more severe episode a few days later on March 5th, in which I had to receive urgent care. It was shortly after lunch which included a spicy hot sauce I had a little bit of.  I started having a similar reaction as earlier described, which eventually subsided once at the doctors office for a bit. However, it did lead to a panic attack, which is something I had never had before.  Overall, I had never reacted like this before. I am wondering if one the side effects of the vaccine may be causing it.
patients has received both the regular and the booster Pfizer Covid vaccines but subsequently had a baby demise; This is a spontaneous report from a non-contactable nurse. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiry date not reported), via an unspecified route of administration on an unspecified date, as dose 1, single, and then second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiry date not reported), via an unspecified route of administration on an unspecified date, as dose 2, single, and then third dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiry date not reported), via an unspecified route of administration on an unspecified date, as dose 3 (booster), single, all for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received both the regular and the booster Pfizer covid vaccines but subsequently had a baby demise on an unspecified date. It was reported that the patient wants to donate the fetus to Pfizer for eventual studies. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported event of fetal demise due to temporal relationship. However, the reported event may possibly represent intercurrent medical condition in this patient.   There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications.   This case will be reassessed upon receipt of follow-up information.   The impact of this report on the benefit/risk profile of the Pfizer product 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.
A few hours after the vaccination i started having increase bowel movements and my arm was tingling more often. Since then I had been hospitalized for a bowel obstruction in September and I also developed a mass/ lump in my gland on the right side of my jaw/ chin which i never had before.
Pt was administered the Moderna COVID19 vaccine at approximately 3:20 PM. Pt sat in observation and after about 15 minutes she reported pain and a sensation of heat at the injection site. Pt denied other symptoms at the time. EMS arrived on scene. At the time the pt had broken out into a rash on the arm where the injection was given. Pt was evaluated by EMSA. BP 169/112 repeat 170/97. HR 115. Rash continued to spread to pt's chest, neck, and other arm. Pt agreed to be transported to Hospital. Paramedic administered IM Benadryl. Pt did not have any difficulty breathing or swelling at the time she left the clinic.
Next day post vax, the pt noticed rash on legs described as blotchy. Awoke Sunday with rash on face and arms. Pt was seen and treated with Atavax and Benadryl.
Patient reported no significant medical history or conditions prior to vaccination. About five minutes post-vaccination, he appeared to have a seizure. EMS was called and patient responded well to water and crackers. He then reported a history of seizure activity.
Information has been received from a medical assistant concerning a male patient with no known drug reactions/allergies, who on 03-NOV-2008, was vaccinated with a dose of PNEUMOVAX (lot # 659148/1382U).  Concomitant therapy included influenza virus vaccine (unspecified) (manufacturer unknown).  The medical assistant reported on 03-NOV-2008, the patient complained of cellulitis like injection site reaction with the vaccination.  The lot check has been requested by the medical assistant.  There were no lab diagnostics.  The patient sought medical attention.  A standard lot check investigation was performed.  All in-process quality checks for the lot number in question were satisfactory.  The lot met the requirements of the agency and was released.  This is one of two reports received from the same source.  Additional information is not expected.
Patient looked normal and relaxed before and during vaccination. About 5-10 minutes after vaccination, patient passed out (fainted) while sitting down in a chair.  Moved patient on to floor lying down flat and observed him for a few seconds. Patient was un responsive and appeared to struggle to breath. Asked my staff to call 911 for emergency services, and to bring an Epipen  just in case, and started to perform CPR on the patient. The patient gained consciousness in about 15 chest compassions and became responsive. He answered the questions like  his name, where he lives etc. As the patient became conscious,  responsive and appeared to breath normally, I did NOT administer Epipen.  Kept patient in observation and kept him engaged in talking until EMS personnel have arrived. They checked his vitals and blood glucose. In the conversation with   EMS personnel, they said he is hypertensive and hyperglycemic.  Ems took him to the ambulance by walking him (stretcher wasn't necessary)
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Mar2021 as dose 1, single (Batch/Lot number: unknown), on 23Apr2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 08Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 27Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 58 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "thyroid cancer" (unspecified if ongoing), notes: other medical history: thyroid cancer/ take synthroid. Concomitant medication(s) included: SYNTHROID taken for thyroid cancer. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical Information: The patient had no other medication in 2 weeks. The patient has anti-viral product Plaxlovid for COVID 19 Treatment from 23Jun2022 to 27Jun2022. No known allergies were reported.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Pt. Stood and became weak. Pale. Dizzy. Stare. Unable to tell nurse name or where she was. Assisted to chair by nurse. Ammonia capsule used and pt immediately able to respond to name and location. Pediatrician called for assesssment of child. Mom verbalizes child has history of light headedness when standing up too fast.
Diarrhea, fatigue, headache, weakness, fever lasting roughly 36 hours
This spontaneous report as received from a Licensed Practical Nurse refers to a patient of 15 years old adolescent patient and unknown gender. On 15-SEP-2014 the patient was vaccinated with a dose of an improperly stored GARDASIL (lot J015378, expiration date 09-APR-2016) (dose, route, were not reported). No adverse effect was reported. The outcome of events reported was unknown. No product quality complaint was involved. This is one of several reports received from the same source. Additional information has been requested.
Chills starting within 12 hours that lasted for 4 hours, headache, body aches specifically in lower back and knees and general feeling of malaise. Loss of appetite that lasted 2 days.
Fever of 101 , (and I am normally cold, like 97-98, not the regular 98.6) Bad headache Chills Joint pain all over
Headache, Myalgia, Fever, NauseaVomiting, CHILLS, PERSPIRATION Narrative:   Other Relevant History:
ON TENTH DAY, BURNING ITCHING RED AREA AT INJECTION SITE.  DESCRIBED AS COVID ARM ON INTERBET,  ONGOING AT THIS POINT IN TIME, RED BUT NOT BURNING OR ITCHING NOW.
Slightly itchy rash & tenderness, redness at injection site started on day 8 after Moderna vaccine. Also mild pain in shoulder & neck. Ongoing.
Pt developed complete paralysis and she was hospitalized for a month with physical therapy and one month in a nursing home for paralysis treatment. The discharge summary states GBS, and congestive heart failure. Annual follow up states right and left foot totally numb up to the ankle. No individual toe movement on either foot. Unable to walk properly. Contracted Guillian-Barre Syndrome after receiving the flu shot and has the above symptoms since then.
In the 4 days since vaccination patient has had intermittent fevers described as "hot flashes" and light-headedness.
No adverse event; Patient received vaccine 1 day past its use by date.; Patient received Moderna Covid-19 bivalent booster vaccine on 22-Sep-2022 and second bivalent moderna on 19-May-2023; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received vaccine 1 day past its use by date.), EXTRA DOSE ADMINISTERED (Patient received Moderna Covid-19 bivalent booster vaccine on 22-Sep-2022 and second bivalent moderna on 19-May-2023) and NO ADVERSE EVENT (No adverse event) in a 76-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch nos. 069H22A and AS7140C) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 Vaccine (Dose 1, lot number 015M20A) on 16-Feb-2021, Moderna COVID-19 Vaccine (Dose 2, lot number 044A21A) on 16-Mar-2021, Moderna COVID-19 Vaccine (Dose 3, lot number 939903 , received in left arm) on 22-Oct-2021, Moderna COVID-19 Vaccine (Dose 4, lot number-335M21A expiration date 14-July-2022 and received in right arm) on 18-Apr-2022. Past adverse reactions to the above products included No adverse event with Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine and Moderna COVID-19 Vaccine.   On 22-Sep-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 19-May-2023, received sixth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On 19-May-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received vaccine 1 day past its use by date.) and EXTRA DOSE ADMINISTERED (Patient received Moderna Covid-19 bivalent booster vaccine on 22-Sep-2022 and second bivalent moderna on 19-May-2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received vaccine 1 day past its use by date.), EXTRA DOSE ADMINISTERED (Patient received Moderna Covid-19 bivalent booster vaccine on 22-Sep-2022 and second bivalent moderna on 19-May-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient received vaccine 1 day past its use by date.) and EXTRA DOSE ADMINISTERED (Patient received Moderna Covid-19 bivalent booster vaccine on 22-Sep-2022 and second bivalent moderna on 19-May-2023).    No concomitant information was reported. It was reported that no adverse reactions were reported. No treatment information was provided.
Extreme and abnormal vaginal bleeding unrelated to menstrual cycle after Pzifer-BioNTech COVID-19 Vaccine shot in the left arm
Soreness, fatigue, return of same odd headache I had when I had Covid on December 11, 2020. Fatigue continued for the following week, and during that time, I developed a rash on my left arm inside the elbow and spreading over my forearm. It itched and bothered me but responded to frequent use of lotion. It stayed with me about 10 days.
High fever >103 degrees, chills, nausea, vomiting - tylenol and ibuprofen at home, occurred approximately 13.5 hours after vaccination, lasted 24 hours. Headache - tylenol and ibuprofen at home, occurred approximately 13.5 hours after vaccination, lasted 4 days Pain and rash on left arm- site of injection, tylenol and ibuprofen at home, began immediately after vaccination, has not resolved. Dizziness- no treatment, began about 15 hours after vaccination, still not resolved. Ringing in ears- no treatment, began about 24 hours after vaccination, still not resolved.
Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Additional Details: rash on right leg
doctors found a mass on my breast and I am waiting on results of a biopsy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BREAST MASS (non-serious), outcome "unknown", described as "doctors found a mass on my breast and I am waiting on results of a biopsy". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
13Nov90 pt vax 3rd dose;  did not seroprotect.  Pt vax 4th dose and did seroprotect.
About 15 minutes after the injection I started getting a metallic taste in my mouth.  Talked to a nurse and was told it was ok, would not last too long and would not hurt me.  My taste is still off a month later.  About 10 days after the first injection there was a large raised red area around the injection site.  Itched a little, but only lasted 2 days.  Was also very tired for a few days after the injection.   After second injection on 5/6/2021, Moderna lot # 007C21A, the bad taste continued.  About 12 hours after injection I had the chills and uncontrollable shaking.  No temperature though.  Was chilled off and on for 2 days.  Also was very tired again and had a headache.  By day 3 felt normal except for bad taste in my mouth.
Headache, chest pain, body aches, tired.  Chest pain, in the ribcage area just started 33 hours after the 2nd dose
6x7 cm area of redness, warmth, mild tenderness (L) deltoid area
The day after the 2nd shot, I started having floaters in my left eye. I checked with my optometrist, and was referred to a doctor. The floaters were numerous and monitored until they subsided somewhat. A procedure, using an injectable dye, was given to allow the doctor to see in the back of the eye. He was able to see what was described to me as an aneurysm. He told me a laser treatment was needed. And that is what was done. A follow up is scheduled for August, unless other symptoms start.
Swollen uvula 1 day post vaccination of Typhoid and Anthrax vaccine.
The day after vaccination, I experienced fever, chills, muscle aches, and a sore arm. Symptoms lasted approximately 24 hours, and were self-resolving.  Early in 2020, I was diagnosed with Covid-19 infection. The severity of the symptoms from the vaccine were just as intense as the infection; however, the duration was significantly shorter.
Chest pain & swollen neck (also weakness, nausea, headache &  body aches) occurred the morning after the vaccine.  She went to the ER, was given steroids and epinephrine, and was discharged the same day.
Almost immediately after the first dose my heart rate increased rapidly (130-140 bpm) and I began profusely sweating. It last about 45 minutes and then subsided. My tounge also felt funny and I felt dizzy for a little bit.  I was woken up out of dead sleep a little after midnight the night I received the vaccine and my heart was racing again and lasted about an hour. The next day I just felt off but nothing specific. By 3 PM the next day I felt fine. I tried to stay as hydrated as possible and used cold compresses while my heart was racing.