chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Blackout; Sleeping a lot; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 22Mar2021 (Batch/Lot Number: EN6204) at the age of 42-years-old as single dose for covid-19 immunisation.  Medical history included seizure from 1994 to an unknown date (it is been happening since the patient was a teenager), epileptic from an unknown date and unknown if ongoing. Concomitant medication included levetiracetam taken for seizure from an unspecified start date and ongoing. The patient reported that she had like blackout from, assuming the vaccine the next day on 23Mar2021. It was kind of later in the day and then next day, 23Mar2021, she was just having kind of had a blackout and she was sleeping a lot and may have had a seizure, she was not really sure as she was sleeping a lot and may had a seizure; she was not sure and she was epileptic. The patient was grateful that she got the vaccine. The patient underwent lab test and procedures which included blood test: unknown on an unspecified date. The patient was recovering from the events.  Information on the lot/batch number has been requested
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 04-FEB-2016 the patient was vaccinated with an improperly stored dose of GARDASIL 9 (strength 0.5 mL, lot # L027282, expiration date 21-SEP-2017, dose and route were unknown). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion four times. The total cumulative excursion time (hour), the highest recorded temperature (Fahrenheit degree) and the type of excursion (R/F) for the first excursion was 24, 48 and R. The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree) and the type of excursion (R/F) for the second excursion was 120, 29 and R. The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree) and the type of excursion (R/F) for the third excursion was 24, 31 and R. The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree) and the type of excursion (R/F) for the fourth excursion was 56, 33, and R. This is one of several reports received from the same source. Additional information has been requested.
Pt came to ER c/o upper abdominal pain with nausea and vomitingx3 days.
I was 3 days into my menstrual cycle when I received the vaccine. Normally by day 4 my bleeding would get very light almost spotty in nature rather than a constant bleeding. By day 9 it was extremely heavy with a serious amount of large, golf ball size clots. Bleeding was so heavy and has been since receiving the vaccine that when going to the bathroom it sounds like I am voiding rather than changing a tampon. The super plus tampons and a heavy pad are saturated in less than 2 hours and to date it has just got to the point that a super plus tampon will last 2 hours and will be leaking before that 2 hours is up. My normal menstrual cycle lasts a max of 5 to 6 days with the last two days being spotty not even a light consistent flow.  I have had a severe headache for 2 weeks now and nothing is helping it at all. Have been to the GYN and my PCP and nothing else is wrong that could be causing this so I was instructed to file this because it is an adverse reaction. I am also a Nurse and will be forced to take the 2nd injection in 8 days and with the wax the bleeding is still going, I will more than likely still be bleeding when I get the 2nd injection. Somebody has to study this and make sure this doesn't happen to others and figure out how to change the FDA approved vaccine so that it doesn't do this for the future injections we have to get.  Thanks
chills, muscle pain at site of injection and generally, fatigue, headache, woke from sleep at 2 AM, continued through that day
Hep A Lot # 4G7P2 given in (L) deltoid and within 30 sec. and fell floor. Water given, client laying down. BENADRYL 50mg IM given. After 30 min. he's sitting up and feeling improvement. Walked and weak again. Sat in chair. Someone here to drive him home. Feeling better.
Iritis type reaction in left eye. Posterior synechiae. (iris is adhering to the lens of my eye)
Left upper arm erythema, swelling with mild induration and warmth. Initially had pain x1 day, pain now resolved. Full ROM arm continue ice, ibuprofen and try antihistamine.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's pertinent medical history, current conditions and concomitant medications were not reported. On 26-APR-2016 the patient was inadvertently vaccinated with an expired dose of VARIVAX (dosing details were not reported) (lot # K002912 with expiry date of 26-FEB-2016). No adverse effects were reported. There was no product quality complaint involved. Additional information has been requested.
Information has been received from a physician concerning a 14 month old female who on 14-MAR-2007 was vaccinated in the right leg with 0.5 ml, one dose, of ProQuad, and immediately developed a welt at the injection site. Concomitant therapy Vaqta, which the patient also received that same day, in the left leg without any reaction. Unspecified medical attention was sought. The patient's status at the time of the report was unknown. There was no product quality complaint. Additional information has been requested.
This case was reported by a pharmacist via call center representative and described the occurrence of leg pain in a 66-year-old male patient who received SHINGRIX (batch number P3777, expiry date 30th January 2020). Concurrent medical conditions included diabetes mellitus and stroke. On 7th December 2017, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In December 2017, 7 days after receiving SHINGRIX, the patient experienced leg pain. On an unknown date, the outcome of the leg pain was recovered/resolved. The reporter considered the leg pain to be almost certainly related to SHINGRIX. Additional details were reported as follows: The patient received the vaccine on right arm. Approximately 1 week after receiving the 1st dose of SHINGRIX, the patient experienced bilateral leg pain from thigh to calf. He rated the pain as 3 on a scale of 1 to 5. The patient did not report the event immediately or seek treatment. The pain resolved within 2 to 3 weeks. This case has been linked with case US2018GSK048555 (same patient) for 2nd suspect.
Fever, Chills, Fatigue, swelling at injection site with pain, Hives
Shoulder pain, aching getting worse as time went on. Rash broke out approximately 22nd or 23rd then got much worse. Went to doctor on 26th was told it is shingles - given medication.
Welts and rashes; Welts and rashes; This is a spontaneous report from a contactable nurse. This nurse reported similar events for two patients. This is the 2nd of the two reports.   A patient of unspecified age and gender received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date: unknown), via an unspecified route of administration on 11Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date for COVID-19 immunization. The nurse reported that the patient received the second dose of the vaccine on Monday (11Jan2021) and broke out in welts and rashes in Jan2021. The patient was given steroids at home and did not report respiratory distress. The outcome of the events was unknown    Information on the batch/lot number has been requested. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021030825 Same reporter/drug/event; different patient
headaches; Continual lower extremity muscle soreness/pain; joint pain in a majority of body; This is a spontaneous report from a contactable other healthcare professional. A 45-year-old female patient received bnt162b2 (BNT162B2), dose 1 intramuscular, administered in Arm Left on 21Dec2020 11:45 (Batch/Lot Number: EK 5730) as 1ST DOSE, SINGLE for COVID-19 immunization. The patient was not pregnant at the time of vaccination administered in Hospital. The patient medical history included migraine, asthma and chronic gastritis. Concomitant medications included topiramate, sertraline and montelukast. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took ibuprofen and experienced drug hypersensitivity. On 23Dec2020 13:15, the patient experienced headaches, continual lower extremity muscle soreness/pain, joint pain in a majority of body. The patient received bnt162b2 (BNT162B2) dose 2, via an intramuscular route of administration, administered in left arm on 11Jan2021 (Lot Number: EK 9231), at single dose for COVID-19 immunization. The patient was visited to physician office and seen in the emergency department. The patient underwent lab tests and procedures which included SARS-CoV-2 test: negative on 12Feb2021. Since the vaccination, the patient has been tested for COVID-19. The patient received pain medication and lab workup as the treatment for adverse events. The outcome of events was not recovered.  No follow-up attempts are possible. No further information is expected.
Medical assistant asks for stability information following several temperature excursions. On 16Feb2023 2100: 8.51C 2115: 8.87C 2130: 8.52C 2145: 8.05C On 19Feb2023 2315: 8.05 2330: 7.86C 2345: 8.01C On 20Feb2023 0145: 8.36C On 25Apr2023 1545: 9.18C; This non-serious, spontaneous safety report was received on 22-JUN-2023 from a physician.  It was reported that the patient did not experience any adverse event (Temperature excursion only).  Due to the nature of the event, the causality between the event "Medical assistant asks for stability information following several temperature excursions. On 16Feb2023 2100: 8.51C 2115: 8.87C 2130: 8.52C 2145: 8.05C On 19Feb2023 2315: 8.05 2330: 7.86C 2345: 8.01C On 20Feb2023 0145: 8.36C On 25Apr2023 1545: 9.18C" and Vaxelis was not applicable.  For reference purposes, the case is linked to MCM-004924 and MCM-004930.  Further information is not expected.
the patient was administered improperly stored VARlVAX; This spontaneous report has been received from a registered nurse concerning to a 5-years-old male patient.   Information concerning patient's concurrent conditions, pertinent medical history, drug reactions/allergies and concomitant medications were not reported.   On 14-AUG-2020, the patient was vaccinated with an improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (dosage regimen and route of administration were not reported), lot # T002848, expiration date 23-JAN-2022, administered as prophylaxis. The vaccine was reconstituted on a properly stored sterile diluent (MERCK STERILE DILUENT) (lot # S008566, expiration date 16-NOV-2021).   The improperly stored dose experienced a temperature between (-14 degrees Celsius (°C) to -10 °C) average temperature was (-12.1 °C), for 3 hours, with multiple excursions of -9 °C to 8 °C, average temperature was -7.5 °C for 8 hours 30 minutes. The call was due to a digital data logger. There was not previous temperature excursions. No additional information was provided.
Vaccine administered to patient < 16 years old, outside of EUA.  No adverse event reported by the patient's father.
Runny nose; coughing; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 47-year-old male patient received BNT162b2 (BNT162B2), on 29Dec2021 as dose 1, single (Batch/Lot number: unknown) at the age of 45 years for covid-19 immunisation. The patient's relevant medical history included: "if covid prior vaccination: Yes" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: RHINORRHOEA (non-serious), outcome "not recovered", described as "Runny nose"; COUGH (non-serious), outcome "not recovered", described as "coughing". Therapeutic measures were not taken as a result of rhinorrhoea, cough. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300281087 same patient/event, different vaccine dose.;
woke up with body aches and fever of 101/did home test and came positive; woke up with body aches and fever of 101/did home test and came positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12Feb2021 at 14:00 as dose 1, single (Batch/Lot number: unknown), in left arm, on 16Apr2021 at 13:00 as dose 2, single (Batch/Lot number: unknown), in left arm and on 19Jul2021 at 11:00 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Has mild Glaucoma" (unspecified if ongoing); "mild aortic regurgitation" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 18Jul2022, outcome "recovered" (Jul2022) and all described as "woke up with body aches and fever of 101/did home test and came positive". The patient underwent the following laboratory tests and procedures: Body temperature: (18Jul2022) 101; SARS-CoV-2 test: (18Jul2022) Positive, notes: did home test and came positive; (25Jul2022) Negative, notes: tested negative on seventh day; (28Jul2022) Positive, notes: tested again and it came very sharp red positive; (01Aug2022) Positive, notes: still positive but with lighter line. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient started feeling down after her daughter's family caught COVID. After three days, on 18Jul2022, she woke up with body aches and fever of 101. She did a home test and came positive. She called her PCP and asked for the anti-viral medicine as she is over 65 and has a very mild heart aortic regurgitation. She started taking the medicine on the 18th and continued for five days as prescribed, her symptoms improved in two days, and she was feeling back to normal on my fourth day. She tested negative on the seventh day but didn't do test on the sixth. After three days from testing negative, she started feeling a mild to medium sinus congestion and thought it was just her regular sinus issue that she got after she catch cold, but after watching the news about the rebound cases, she tested herself again and it came very sharp red positive. She didn't have any other symptoms but isolated herself again. She tested yesterday, 01Aug2022, and still showed positive but with lighter line. She will test herself tomorrow.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
March 20, 2021, at 9:07 PM - I began having chills that evening, then aches and pains. My husband suggested I take Theraflu Nighttime for the pain and to sleep, which I took. Around 4:42 AM, I woke up to use the restroom. I was drenched so I guess I sweated out a fever. Went back to bed. My husband woke me up and suggested I drink some water. I went to the restroom, still feeling out of it, then made my way to a chair where I sat and down and collapsed. According to my husband he tried several times to revive me and finally I began gasp for air. The paramedics arrived and I was taken to Medical Center.
Approximately 12 hours (3:30am on 2/16/21) after receiving vaccine I started to get the chills, they would start at my feet and run up my body. At approximately 8am on 2/16/21 I took my temperature and it was 102.5 F. I took Ibuprofen and felt somewhat functional for several hours. Throughout the day on 2/16/21 I had recurring fever, chills, fatigue, no appetite and a very sore right arm. At approximately 9pm on 2/16/21 I ate a small meal and went to bed. I woke up on 2/17/21 feeling fine with no symptoms.   For approximately 2 weeks following my 2nd dose of Moderna on 2/15/21 my right arm would become numb and tingly.  This happened periodically throughout the day. After approximately 2 weeks the numbness and tingling went away.
Donor came to center on 5-9-08 to donate. Donor had red rash on right arm and some swelling which donor states believes is from Rabies immunization on 5-7-08.
About 8:30 AM on 4/26/11 sister of patient called health department. Stated patient's lips became swollen & numb at approx 3:30pm on 4/25/11. Able to swallow, breathe, no fever, n/v. No swelling/redness of injection site. Counseled to see private physician for further evaluation/treatment.
Information has been received from a consumer concerning his 24 years old fiancee who on 25-MAY-2009 received the first dose (0.5ml) of GARDASIL. There was no concomitant medication. On 25-MAY-2009 the patient experienced pins and needles feeling in her hands and tingling. The patient was admitted in hospital (name and address unspecified) for whole day of 26-MAY-2009. A GBS test was performed (results not reported). The patient's experienced pins and needles in her hands and tingling persisted. Additional information has been requested.
Chest pain in middle of night with sweats; Chest pain in middle of night with sweats; This is a spontaneous report from a contactable other hcp (patient).    A 42-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 17Aug2021 16:00 (Batch/Lot number was not reported) as single dose (at the age of 42 years old) for COVID-19 immunisation. The vaccine was administered at Pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. Medical history none. There were no concomitant medications. Previously the patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 27Jul2021 (at the age of 42 years old) in the left arm for COVID-19 immunisation. On 19Aug2021 01:00, the patient experienced chest pain in middle of night with sweats with outcome of recovering. No treatment was required. The case was assessed as non-serious.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Information has been received from a pharmacist referring to a 40 year old female patient. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were unknown. On 07-NOV-2018, the patient was vaccinated with varicella VARIVAX (lot # R008393 and expiration date 20-MAR-2020; strength, dose and frequency were not reported) and M-M-R II (strength, dose, frequency, batch/lot # and expiration date were not reported) subcutaneously "on the top part of the arm" for prophylaxis (reported as for school) (vaccine administered at inappropriate site). On the same date, the patient developed "pain in the arm and a local reaction at the injection site". No treatment was given to the patient. Information about lab diagnostics/studies was unknown by the reporter. The patient did not seek medical attention. The outcome of pain in the arm and a local reaction at the injection site was reported as recovered. The causality between the events and VARIVAX and M-M-R II was not reported.
Weakness; Fatigue; Sore Arm; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weakness), FATIGUE (Fatigue) and MYALGIA (Sore Arm) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, the patient experienced ASTHENIA (Weakness), FATIGUE (Fatigue) and MYALGIA (Sore Arm). On 25-Apr-2021, ASTHENIA (Weakness), FATIGUE (Fatigue) and MYALGIA (Sore Arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant product use was provided by the reporter.  No treatment medication was provided.   This case was linked to MOD-2021-257969 (Patient Link).
Patient broke out on an all-body rash that was severely itchy the night she hot the flu shot. It last for 2 days and recovered after treating with BENADRYL. She has also had diarrhea since the injection but is recovered now.
100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again; No Adverse Event; 100 bivalent boosters were given yesterday from vials that were 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 (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again), PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) 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 (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again), PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown. Not Provided      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 (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again).    This case for patient 86 out of 100 patients. Concomitant medications were not reported.  No treatment information was provided by the reporter.   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