chrisvoncsefalvay/vaers-outcomes huggingface dataset:
TWO SMALL SPOTS OF SKIN CANCER/SKIN CANCER TAKEN OFF FACE; SUN DAMAGE SKIN; MORE TIRED AND THAN USUAL; This spontaneous report received from a patient via other manufacturer AbbVie concerned a 78 year old male with unknown race and ethnicity. The patient's weight was 162 pounds, and height was 70.8 inches. The patient was non tobacco user, and abstained from alcohol. The patient's concurrent conditions included nerve pain and moderate to severe rheumatoid arthritis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) 40 mg daily from 2016 for moderate to severe rheumatoid arthritis. Concomitant medications included gabapentin for nerve pain, folic acid, methotrexate and prednisone for rheumatoid arthritis.  On an unspecified date, the patient had two small spots of  basal cell carcinoma (skin cancer/skin cancer taken off face) probably from sun damage which were removed by Mohs surgery from his neck and jaw and more tired and than usual. Laboratory data (dates unspecified) included: Biopsy (NR: not provided) unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from two small spots of skin cancer/skin cancer taken off face, and more tired and than usual, and the outcome of sun damage skin was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210614453-covid-19 vaccine ad26.cov2.s -Two small spots of skin cancer/skin cancer taken off face. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Right arm aches where the shot was given, some days worse than others.; This is a spontaneous report from a contactable consumer, the patient. A 66-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162) via an unspecified route of administration in the right arm on 20Apr2021 at 10:45 (at the age of 66-years-old) as a single dose for COVID-19 immunisation. The patients' medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included colecalciferol (VIT.D3), ascorbic acid (VITAMIN C) and vitamin b complex (B-COMPLEX); all from unknown dates for unspecified indications. The patient previously received TAMIFLU and experienced a drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the right arm on 30Mar2021 at 10:30 (at the age of 66-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines with in four weeks of the COVID-19 vaccination. On 20Apr2021 at 13:00, the patient experienced "right arm aches where the shot was given, some days worse than others." The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event "right arm aches where the shot was given, some days worse than others."  was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
2 1/2 hr p/receiving vax pt vomited then was noted to be pale, listless, & poorly responsive; brought to ofc for eval-pale, sluggish, capillary refill delayed, pulse >200, BP 100/p; monitored x 6 hr in hosp, condition improved;
dizzy; throwing up; fever; headache; nausea; This case was reported by a consumer via other manufacturer and described the occurrence of dizziness in a adult female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included TOZINAMERAN (PFIZER-BIONTECH COVID-19 VACCINE) for prophylaxis.   The patient's past medical history included splenectomy. Previously administered products included Shingles vaccine (1st dose received in right arm).   On 8th January 2021, the patient received the 2nd dose of Shingles vaccine. On an unknown date, the patient received the 1st dose of PFIZER-BIONTECH COVID-19 VACCINE. In January 2021, less than a week after receiving Shingles vaccine, the patient experienced dizziness, vomiting, fever, headache and nausea. On an unknown date, the outcome of the dizziness, vomiting, fever, headache and nausea were unknown.   It was unknown if the reporter considered the dizziness, vomiting, fever, headache and nausea to be related to Shingles vaccine.  Additional information was provided as follows: The case was reported by patient herself. The age at vaccination was not reported, however she was in her 60s. Last Friday from the day of reporting, the patient got her mass shingles vaccine shot in her left arm.  The patient experienced reactions that were dizzy, throwing up, headache, fever and nausea. The patient wanted to know how long till she get the 2nd dose of the COVID vaccine, Could she get the COVID vaccine elsewhere if did not get it at work a day after reporting and were both doses of the COVID vaccine from the same company. The patient would like to know what Pfizers recommendation was. Should she get the COVID vaccine shot a day after reporting based on her reaction to another vaccine. The patient's family doctors nurse said to go ahead and get the vaccine. The reporter did not consent to follow up. It was unknown if the reporter considered the dizziness, vomiting, fever, headache and nausea to be related to Pfizer-Biontech COVID-19 Vaccine.
MUSCLE AND JOINT ACHES IN LEGS, BEGAN DAY AFTER 2ND VACCINATION AND SUBSIDED FOR A WHILE THEN RETURNED, WORSE AFTER EXERCIZE OR WALK. FATIGUE, LOSS OF APPETITE
Patient was instructed to sit down and remain seated in the waiting area for 15 minutes to monitor for any ADR.  She stood shortly before the timeframe (about 14 minutes after administration of vaccine) and had syncope/fainted and hit the back of her head on the floor.  She did not lose consciousness/was responsive immediately after falling.  The pharmacist and store management had the patient lie down on her back and elevate her feet.  An open airway was maintained and the patient had no trouble breathing.  Cold compresses were applied to her head.  ED was called and arrived promptly to provide medical attention.
Patient came to facility to receive 2nd dose Pfizer. Patient reported that she had a slight tingling sensation of the tongue . Patient reported that her symptom started a few hours after her vaccination. Patient reported symptom went away on its own and took no medications for it.
Is out of nowhere / more bleeding, feels like she had her period; Had cramps pain; Started bleeding again like she had a period again, but finished her period last week; This spontaneous case was reported by a consumer and describes the occurrence of DYSMENORRHOEA (Had cramps pain), MENSTRUAL DISORDER (Started bleeding again like she had a period again, but finished her period last week) and HEAVY MENSTRUAL BLEEDING (Is out of nowhere / more bleeding, feels like she had her period) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse reaction (Medical history not provided). Concomitant products included ETHINYLESTRADIOL, NORGESTIMATE (SPRINTEC) for Birth control.    On 07-Apr-2021 at 10:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced DYSMENORRHOEA (Had cramps pain) and MENSTRUAL DISORDER (Started bleeding again like she had a period again, but finished her period last week). On 09-Apr-2021, the patient experienced HEAVY MENSTRUAL BLEEDING (Is out of nowhere / more bleeding, feels like she had her period). At the time of the report, DYSMENORRHOEA (Had cramps pain), MENSTRUAL DISORDER (Started bleeding again like she had a period again, but finished her period last week) and HEAVY MENSTRUAL BLEEDING (Is out of nowhere / more bleeding, feels like she had her period) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not reported.   Reporter did not allow further contact
anaphylactic reaction; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 2022NVX-US-000003867.  A female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ANAPHYLACTIC REACTION (medically significant), outcome "unknown".  Clinical course: On 14Oct2022, it was reported that a patient started treatment on an unspecified date with Pfizer BioNTech Covid-19 Vaccine dose 1 for an unspecified indication. It was reported the patient had an anaphylactic reaction to the first dose of the Pfizer vaccine and did not take the second dose. No further follow-up is anticipated.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Pt. states that after receiving the 3rd dose of Moderna 12/20/2021 (Influenza Quad Right Arm), started experiencing symptoms 12/29/2021 on itchiness on the soles of both feet and itchiness in both palms of hands. Also itchiness continuing to spread throughout the Left thigh, back area, and Left arm. No noted Primary visit/communications.
VOMITING; LOST SIX POUNDS; CANNOT EAT; WEAKNESS; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 14-MAY-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 14-MAY-2021, the subject experienced vomiting. On 14-MAY-2021, the subject experienced lost six pounds. On 14-MAY-2021, the subject experienced cannot eat. On 14-MAY-2021, the subject experienced weakness. Laboratory data included: Weight (NR: not provided) lost six pounds. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from weakness, and the outcome of vomiting, lost six pounds and cannot eat was not reported. This report was non-serious.
Dizzy; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration, on 27Feb2021 at 11:30 (Batch/Lot number was not reported) as dose number unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On 28Feb2021, the patient got up to walk and felt dizzy. The patient has been dizzy all day and was dizzier when getting up to stand. The patient asked if someone could still get dizzy after 15-30 minutes period from the vaccine. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
site of the injection was quite sore and I have had that before but not as bad; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old male patient received bnt162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "site of the injection was quite sore and I have had that before but not as bad". Relevant laboratory tests and procedures are available in the appropriate section. The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
patient had hypothermia, with a temperature of 92.1 degrees Fahrenheit; trouble in breathing; she was freezing inside out; immediately got sick; Based on information previously received, the following information [Event hypothermia upgraded to serious from non-serious (Medically significant as per important medical event (IME) list)] has been amended.  Initial information received on 15-Feb-2021 regarding an unsolicited valid serious case from non-healthcare professional.  This case involves a 78 years elderly female patient who got immediately sick (illness), hypothermia, with a temperature of 92. 1 degrees Fahrenheit (hypothermia), trouble in breathing (dyspnoea) and was freezing inside (feeling cold), after receiving INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  Medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On an unknown date in December 2020, the patient received a 0.7 ml dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [lot number and expiry date not reported] via unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed hypothermia, with a temperature of 92. 1 degrees fahrenheit (hypothermia) (serious event), immediately got sick (illness) (on the same day), trouble in breathing (dyspnoea) and was freezing inside (feeling cold) (non-serious events) (exact latency unknown), following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE. Hypothermia was assessed as medically significant.  Other relevant laboratory data not reported.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome is unknown for the reported events.; Sender's Comments: This case involves a 78 years elderly female patient who had hypothermia, illness, dyspnoea and feeling cold after receiving FLUZONE HIGH-DOSE QUADRIVALENT. The time to onset was compatible. However, concomitant medication, family history, patient's medical condition at the time of vaccination and other relevant laboratory tests were not reported. Based upon the reported information, the role of the vaccine cannot be assessed.
Information has been received from a health professional concerning a 10.5 year old male with asthma and a penicillin allergy and no other pertinent medical history who in March 1998, was vaccinated with a dose of varicella virus vaccine. Concomitant vaccination that day included a second dose of MMR. On 6/29/04 the patient broke out in an itchy rash and presented to the doctors office on 7/6/104. The child had red vesicles on his arm, left leg, back of neck and lower abdomen in all stages of development. It was reported that symptomatic treatment would be given as needed until all vesicles crusted over. It was unknown if labs were performed and it was reported that the child was recovering with sequelae. No product quality complaint was involved. Follow up information from a nurse indicated that the patient was seen on 7/6/04 with a one week history of an itchy rash that began on 6/27/04. On exam, he had discrete erythematous vesicles on the right lower extremity, back, neck and lower abdomen in various stages of healing. He was sent home for symptomatic treatment and told to isolate until all lesions were crusted over. The patient was seen for an asthma exacerbation on 7/27/04 and the chicken pox was cleared. No diagnostic laboratory tests were performed. No further information is expected.
Chills, headache,lethargic, temp 100.4 lasting  12 hours took ibuprofen 200mg x2 pills every 4 hours  totaling 2 doses
Given ADACEL on 5-25-11. On 5-26-11 had severe muscle aches, joints hurting, nausea, fever, headache and tired . On 5-29-11 bottom lip swollen, tingling and blistery rash and hives on rt torso. On 5-30-11 top lip swollen and tingly with hives on rt side. Given BENADRYL. No signs or symptoms or discomforts May 27, 28 or 6/1/11.
Numbness in left calf and foot and left forearm and hand; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 17Apr2021 at 16:45 (at the age of 62-year-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. The patient did not receive any other medicines within two weeks prior to the COVID-19 vaccine. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 18Apr2021 at 15:30, the patient experienced numbness in left calf and foot and left forearm and hand. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event numbness in left calf and foot and left forearm and hand was not recovered at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Patient received vaccine on 3/31/2008 & was seen for herpes zoster on 9/8/2009.
Swelling of tongue and throat.  Symptoms did not improve and was advised by Dr to visit urgent care on 05/08/2021.  Treated with Benadryl which took the swelling down some. Released with prescription for Benadryl.  Emergency physician said I should not receive another vaccine/booster.  It was another 21 days before swelling was completely gone.
12 hours after the injection I started shivering like I was hypothermic my body temperature dropped to 94.3 this lasted for two days I was in a lot of pain overall body. I had a really bad headache. I could not move my arm where I got the shot without intense pain.. I had overall body aches for four days it took me seven days to somewhat get back to normal and I still don?t feel right I think it could possibly have thrown me into a lupus flare.
Neuropathy; hard time walking; Debilitating; digestive system is not right anymore; Unable to do exercise; hard time doing the dishes or any other task; This serious case was reported by a consumer via interactive digital media and described the occurrence of neuropathy in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced neuropathy (Verbatim: Neuropathy) (serious criteria GSK medically significant), walking difficulty (Verbatim: hard time walking), debility (Verbatim: Debilitating), digestion impaired (Verbatim: digestive system is not right anymore), exercise capacity decreased (Verbatim: Unable to do exercise) and activities of daily living impaired (Verbatim: hard time doing the dishes or any other task). The outcome of the neuropathy was not resolved and the outcome of the walking difficulty, debility, digestion impaired, exercise capacity decreased and activities of daily living impaired were not reported.   It was unknown if the reporter considered the neuropathy, walking difficulty, debility, digestion impaired, exercise capacity decreased and activities of daily living impaired to be related to Shingrix.     It was unknown if the company considered the neuropathy, walking difficulty, debility, digestion impaired, exercise capacity decreased and activities of daily living impaired to be related to Shingrix.   Additional Information: GSK Receipt Date: 26-JUN-2023 The case was received from the patient via (Facebook) interactive digital media. The patient received second dose of Shingrix and four days' after she woke up and had a hard time walking.  She had neuropathy ever since.  She had hard time doing the dishes or any other task. She was livid because they give no warning before they gave the shot. They only told her that her arm would be sore for a few days.  The reporter stated that her body would never be the same. She used to be athletic and now she was unable to do the exercises that she used to do.  Shingrix took away her life and her digestive system was not right anymore. The reporter wish that she had never gotten the Shingrix vaccine. Eventually they would be accountable for this. They were willfully hiding all the information. The patient used to be pro vaccine until she got this one. The patient did not want anyone else to go through this. The patient stated she would rather have shingles for a few weeks that neuropathy for the rest of her life.
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 62-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Sep2022 at 10:00 as dose 5 (booster), single (Lot number: GJ5342) at the age of 62 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 23Apr2022 at 12:30 as dose 4 (booster), single (Lot number: FM9992), in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 12Feb2021 at 13:00 as dose 1, single (Lot number: EN6201), in left arm, on 29Sep2021 at 11:00 as dose 2, single (Batch/Lot number: unknown), in left arm and on 25Jan2022 at 15:00 as dose 3 (booster), single (Lot number: EL9261), in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ATORVASTATIN, start date: Jan2015, stop date: 22Mar2023; VASCEPA, start date: Jan2015, stop date: 22Mar2023; FENOFIBRATE, start date:Jan2015, stop date: 22Mar2023; LISINOPRIL, start date: Jan2018; OMEPRAZOLE, start date: Jan2005; TADALAFIL, start date: Jan2022; DOXYCYCLINE, start date: Jun2022; MELOXICAM, start date: Apr2022; LORATADINE, start date: Jan2005; TESTOSTERONE, start date: Jan2000. Past drug history included: Tetracycline, reaction(s): "Known allergies Tetracycline". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Mar2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (26Mar2023) Negative, notes: Testing negative for COVID using Antigen test on last day on Paxlovid treatment 26Mar2023; (28Mar2023) Negative, notes: tested negative again using Antigen test 28Mar2023; (30Mar2023) positive, notes: Tested positive for COVID using Antigen test 30Mar2023; (03Apr2023) positive, notes: test positive as of today, 03Apr2023. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient was treated with paxilovid for COVID 19 from 21Mar2023 to 26Mar2023.Testing negative for COVID using Antigen test on last day on Paxlovid treatment 26Mar2023 and tested negative again using Antigen test 28Mar2023. Tested positive for COVID using Antigen test 30Mar2023 and continue to test positive as of today, 03Apr2023.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300143686 Same parient/vaccine, different dose/event;