chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A few seconds after shot, pt became pale and immunizer asked if he was ok. His muscles tensed and shook a little and he passed out, falling slightly to the right. The technician was able to place herself between him and the floor and slowly lower down, leaning  against the wall of the pharmacy.  By this point, about 30 seconds at most had passed, and pt was awake and cognitive, but had no recollection of passing out or how he had gotten to the floor. He did know his name and where he was, but was breathing heavy.  We took his blood pressure at this point and it was 82/46 with a pulse in the 40's as well.  Pt refused ambulance and we had him continue to sit on the floor.  Patient mentioned he had this type of reaction in past to other vaccines (not stating what), though only telling us prior he had "slight dizziness once".   He also stated he had not had anything to eat or drink that am so we got him a snack and some water.  Patient continued to breath deeper as we suggested and stay on the floor as we called mgmt from the store.   We took blood pressure about 10 minutes later and it had gone up to 117/71.  and then again 10 minutes later and it was 121/69.  After 30 minutes total, pt asked if he could stand and leave.  He stood with no dizziness and said he felt "fine".   We called patient approximately an hour later at his residence to make sure he got home ok and patient stated he had no other symptoms at that time and continued to feel "normal".
Information has been received from a pharmacist concerning her 17 year old daughter who on unspecified date was vaccinated with the second dose of GARDASIL (dose, route and lot# not reported). In January 2011 the patient experienced planters warts after her second injection of GARDASIL. The patient sought unspecified medical attention. No treatment was given for the event. At the time of the report, the patient had not recovered. Follow-up information was received from the pharmacist indicating that the 20 year old (also reported as 18 year old) (previously reported as 17 year old) female student who on approximately 06-AUG-2010 was vaccinated with the second dose of GARDASIL and on 20-AUG-2010 the patient got planters warts 2 weeks after the second vaccination (previously reported as January 2011). The patient didn't seek medical attention (previously reported as the patient sought unspecified medical attention). At the time of the report, the patient had recovered. No further information is available.
Patient reports dizziness, sore muscles, headache, and nausea that began at 10:30am  this morning after receiving his first dose of Pfizer COVID 19 vaccine.  He said between 10;30am and 11:00am his vision became blurred.  At 2:30pm when patient called to make report he was still experiencing blurred vision. I strongly urged him to go to ER for evaluation or call his PCP ASAP.  He verbalized understanding.
First noticed that it was difficult to hold can of soda and to hold pen right arm. Noticed injection site soreness in upper arm that progressed to forearm, hand, fingers, and palm of hand. Felt that hand motor control was delayed. Felt some numbness on right side of face and foot.
One week after receiving the vaccine, started itching at the vaccination site and developed a red rash.  Still has swollen rash two days later, with soreness when presses on the rash, and the rash area is hot to the touch.
12 hours after receiving 1st rabies vaccine, nausea and abdominal pain, subsided and returned again the following morning and again in the afternoon. Spoke with doctor at our facility, she encouraged me to contact my physician an fill out this on-line form because I am a post weight loss surgery patient.
I was pregnant at the time of the first injection and miscarried before the second. I do not think I miscarried because of the injection because the fetal tissue reflected a genetic issue.  However, since my miscarriage I have had irregular cycles and mid-cycle bleeding.  I also have not ovulated since I had the injections.  My thyroid, prolactin, and other test results indicate that I do not have any medical problems that are the cause of not ovulating.  Therefore, I wonder if the vaccine has anything to do with it.
bluish echymotic patches on face; swelling of face & lip for 1-2 hrs; (onset 1/2 hrs p/vax given);
The patient did not experience any other AEs; received an expired dose of PEDV AX HIB on 4/2/2021; This spontaneous report was received from a medical assistant who was reporting on 15-month-old patient of unknown gender. There was no information about the patients concurrent conditions, medical history, drug reactions or allergies and concomitant therapies provided.  On 02-APR-2021, the patient was vaccinated with expired dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) 1 dose (exact dose, route of administration, anatomical location and strength were not provided; lot number was reported as s030207 and confirmed to be not valid; expiration date was reported as 25-MAR-2021) for prophylaxis (expired product administered).  The patient did not experienced any other adverse events.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Mar2021 at 09:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 70 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  Clinical course: patient did not received other medication in 2weeks. Anti-viral details: Product=COVID 19 Treatment. Treatment start date=21Jun2022. Treatment Stop date=22Jun2022. Adverse event: Stomach upset and diarrhea. Adverse event start date: 21Jun2022. Adverse event start time: 11:00 AM. If patient recovered: Recovered. patient did not have other medical history. patient did not received any treatment ae and had no Known allergies.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
they gave a patient Fluzone Quad but was meant to give the Flublok, no AE; Initial information received on 02-Oct-2019 regarding an unsolicited valid non-serious case received from a non-healthcare professional.  This case involves a 60 years old patient who received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] lot number not reported via unknown route in unknown administration site instead of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV], on an unknown date.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Haemophilia.  It was an actual medication error case due to wrong vaccine administered.  At the time of reporting no adverse reaction was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested.  List of documents held by sender: none.
Patient states she had a fever for 6 hours that started 4 hours after her vaccine was given.
Information has been received  from a patient who was vaccinated with Hepatitis A virus vaccine inactivated. Subsequently, the patient experienced pain and suffering. The reporter felt that pain and suffering was related to therapy with Hepatitis A virus vaccine inactivated. The patient indicated that "maybe we can settle this without a lawsuit". No additional information is available at this time.
After receiving one dose of the Moderna Covid 19 vaccine on May2021, patient immediately started to compulsively gambling; This spontaneous case was reported by a patient and describes the occurrence of GAMBLING DISORDER (After receiving one dose of the Moderna Covid 19 vaccine on May2021, patient immediately started to compulsively gambling) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    In May 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2021, the patient experienced GAMBLING DISORDER (After receiving one dose of the Moderna Covid 19 vaccine on May2021, patient immediately started to compulsively gambling). At the time of the report, GAMBLING DISORDER (After receiving one dose of the Moderna Covid 19 vaccine on May2021, patient immediately started to compulsively gambling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information was provided.  It was reported that patient wants to play and go to the facility constantly.  No treatment was given to the patient.
arm pain; difficulty moving the vaccinated arm; This spontaneous report was received from a physician via company representative and referred to a 73-year-old male patient. The patient's concurrent condition, concomitant therapy, medical history, drug reactions/allergies were unknown.  On 28-MAR-2023, the patient was administered with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (1 dosage form, route, lot #, expiration date and anatomical location were not provided) for prophylaxis.  On 28-MAR-2023, the patient experienced arm pain and difficulty moving the vaccinated arm after vaccination. It was unknown if the patient sought medical attention and gave treatment for events. The outcome of all events was not provided. The causality between pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) and all events was not provided.
Drug ineffective; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old male patient received BNT162b2 (BNT162B2), on 04Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 51 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: COVID-19 (medically significant) with onset May2022, outcome "unknown"; DRUG INEFFECTIVE (medically significant) with onset May2022, outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical Course: Patient received no other medication in 2 weeks. Patient received covd-19 treatment with antiviral drug paxlovid from 22May2022 and 26May2022. No known allergies. Rebound COVID positive 4 days after completing Paxlovid 5 days.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Area became swollen, red, warm to touch, very hard, very itchy. Also had low grade fever.
Convulsive shivering followed by fever (101.4) and body aches, especially neck, hands, and legs.
Extended shoulder pain amd limited range of motion, not in exact injection site but in surrounding tissues in shoulder and upper arm
Chills, body aches, exhaustion, nausea  Symptoms started subsiding after about 10 hours. Full recovery within 24.
Severe headache and body aches on the entire right side of my body(injection side). Chills. Weakness.
Approx 51 hours after vaccination, patient developed 1 1/4" red blotch around vacc. area with soreness, swelling & itching. Symptoms continued for additional 30 hours before improvement. Started to improve after taking BENADRYL. Swelling was up to 4" below vac. site & tingling could be felt in neck & shoulder blade. No fever. Redness lasted 10 days.
Itching 25 minutes after the injection. Itching on arm, neck, back, ears, legs. Nausea and vomiting the next day. Mild nausea the third day.
After his last in a series of three hep.b#3 immunizations, patient developed sever dryness, always having to drink liquids then go to the bathroom, voiding many times during the night, unable to sleep. He got weaker and weaker till he could no longer stand and became unconcious.
Expired moderna vaccine mistakenly administered; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired moderna vaccine mistakenly administered) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 02-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired moderna vaccine mistakenly administered). On 02-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired moderna vaccine mistakenly administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided. Treatment information was not provided.  On 14-Oct-2021, vial was removed from freezer into refrigerator. It was never opened before today and temperature was never compromised.
Client called today stating that he wanted to cancel his appointment for the 2nd Moderna.  He stated that he was bedridden for 4 to 5 days post vaccination with headache, fever and sweats. He continues to have aches especially in the left shoulder area.  He asked for a medical exemption. I directed him to see his medical provider for care and medical exemption as he has not seen a medical provider yet.
extreme exhaustion; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program. A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunisation.  The patient's medical history and concomitant medications were not reported.  The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on unspecified date for COVID-19 immunization. The patient experienced extreme exhaustion on unspecified date (3 days after the second dose). The patient asked if it was normal to have extreme exhaustion after the second dose. Outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
02/16/22 presents to ED for "sore throat, congestion,  and fever". PMHx of "breast cancer currently on chemotherapy" "hyperthyroidism"
Approximate 40 patients received vaccines that have been kept refrigerated for 60 days/43 Total patients affected; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Approximate 40 patients received vaccines that have been kept refrigerated for 60 days/43 Total patients affected) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Approximate 40 patients received vaccines that have been kept refrigerated for 60 days/43 Total patients affected). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Approximate 40 patients received vaccines that have been kept refrigerated for 60 days/43 Total patients affected) had resolved.        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 was provided by the reporter. No treatmentt medications was provided by the reporter.  Vaccines were first frozen on 03-Jul-2021, were taken out to refrigerator at 6.30AM on 03Jun2021, on 03Jul2021 they should have been discarded, but they have been administered ever since. The lot number was 040B21A, it was one box with multiple vials, 40 patients approximate were involved. The update on the excursion was that the 9 vials in question were used on patients through July 29. The update on patients for the AE were that  43 patients were affected.  Fifteen were given 1st doses and 28 were give 2nd doses  between 4 and 26 days past the use by date.   This case was linked to MOD-2021-286864, MOD-2021-286796, MOD-2021-287108, MOD-2021-286869 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 06-Aug-2021: Significant information received on 06 Aug 2021:  Event term updated to Approximate 40 patients received vaccines that have been kept refrigerated for 60 days/43 Total patients affected.
Client reported history of fainting from shots. Staff was already monitoring patient specifically due to previous history of fainting from receiving other vaccinations. Client passed out in the 15 minute wait time and was observed by EMS in a squad where she recovered. At 17:55 BP 103/68  and pulse 68,  at 18:02 BP 106/70 and pulse 98. At 18:06 BP 115/72 and pulse 100. No other adverse reactions reported at the time of this event.
TWINRIX was administered first with no reaction noted. IMOVAX was administered second in the same arm. Within ten seconds the patient complained of feeling warm. He was given water to drink. He began sweating profusely within five minutes. Then he complained of feeling cold. The symptoms lasted for fifteen minutes then he indicated he was feeling better. He stayed at the pharmacy for thirty more minutes. The patient indicated he was better and decided to leave. The patient was called later in the evening and he indicated he was feeling fine. No dizziness, nausea or breathing difficulties were noted.
This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with doses of improperly stored PROQUAD (Merck), (dose, route of administration, injection site, lot number and expiration date were not reported). No adverse experiences were reported. This is one of several reports received from the same reporter. Additional information has been requested.
This is a spontaneous report from a contactable consumer (patient's daughter). A 73-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported) first dose on 28Feb2021 and second dose on 21Mar2021 (both at the age of 73-years-old) via unspecified routes of administration at single doses for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced atrial fibrillation after the first and second dose, both occurred two days after injection (on 02Mar2021 and 23Mar2021, respectively). The event lasted for approximately 12 hours with each episode. Outcome of the event was recovered in Mar2021.   Information on the lot/batch number has been requested.
94-year-old patient presented to emergency department on 4/25/2021 with acute shortness of breath. Diagnosed with COVID-19 on 4/20/2021. Her chest x-ray in the emergency room showed left-sided airspace opacity with some pleural effusion. She was also found to be hypoxic at the assisted living facility and started on oxygen along with nonbreather oxygen mask and admitted to the hospital ICU for further management of COVID-19 pneumonia. There is history of cough and wheezing off and on.
Initial information received on 14-Sep-2018 regarding an unsolicited valid non-serious case received from a consumer. This case involves female patient of an unknown age who experienced heart racing, diarrhea and felt dizzy (light-headed), while she received vaccine FLUZONE QUADRIVALENT. The patient's past medical history included Celiac disease and Autoimmune thyroiditis. The patient's past medical treatment(s), vaccination(s) and family history were not provided. On 12-Sep-2018, the patient received a dose of suspect FLUZONE QUADRIVALENT lot UI975AC via unknown route in the left deltoid (dose not reported). On an unknown date, the patient developed a non-serious heart racing (palpitations) and felt dizzy (light-headed) (dizziness), one hour following the administration of  FLUZONE QUADRIVALENT. On 13-Sep-2018, the patient developed a non-serious diarrhea (diarrhoea), one-day (next morning) following the administration of FLUZONE QUADRIVALENT.  Relevant tests were not reported. Final diagnosis was felt dizzy (light-headed), diarrhea and heart racing. It was not reported if the patient received a corrective treatment. The patient was recovering from the events. Documents held  by sender: none.