chrisvoncsefalvay/vaers-outcomes huggingface dataset:
After receiving the vaccine, I had a fever, chills and pain in the arm for about 60 hours. On 08/01/2022, I started not feeling well with a sore throat that got progressively worse for the next two days. On 08/03/2022 I tested positive with a home test for COVID-19. I contacted my doctor's office and talked to the nurse practitioner who is in charge of the COVID-19 cases. I took an analgesic to help with my symptoms and rested. As of today, I continue to have brain fog and my sleep cycle is off. If I am exhausted, I can fall asleep easy. When I try to go to bed for the night, I'm wide awake.
Discovered following administration that the patients dose was left in the adult bin the refrigerator, drew up dose undiluted and administered - NDC 59267-1055-4 lot # FL8094 expiration per supervisor 8-31-22. Reported to supervisor who will contact manufacturer. To contact patient tomorrow to inquire on any symptoms and once communication with manufacturer occurs to determine if another dose is needed or if sufficient  dosing has occurred.
Sore at injection site (arm), Sore throat, Headache, Exhaustion
Rapid heart beat; Upper back feeling funny; caller was asked regarding blood pressure as she previously stated 120/56.Caller confirms as 102/56, and that it was actually 102/56.; This is a spontaneous report from a contactable consumer or other non hcp(Patient). A 58-year old female patient received first dose of  bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE)(At the age of 58 years old),via an unspecified route of administration, administered in Arm Left on 18May2021 (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for covid-19 immunisation. The patient medical history was not reported. Concomitant medications included metformin,1000 mg, 2x/day for diabetes mellitus, atorvastatin 40 mg(she says long time she means 10 years), 1x/day taken for blood cholesterol increased, cetirizine ,10 mg, 1x/day(caller has been on for three years) taken for hypersensitivity, hydrochlorothiazide, lisinopril (LISINOPRIL HCTZ) 20 mg, 2x/day ,taken for hypertension, gabapentin,900 mg, 3x/day (she has been on for over ten years) taken for surgery. On 18May2021 the patient experienced rapid heart beat , upper back feeling funny , and on an unknown date in 2021 caller was asked regarding blood pressure as she previously stated 120/56.caller confirms as 102/56, and that it was actually 102/56. Patient not visited to Emergency Room or Physician Office. Patient stated that Upper back feeling funny: caller states that it was not in her arm, just in her back but not in the arm or the shoulder. It was just on the left side kind of behind her breast. That started and she waited there for fifteen minutes and she kind of felt it then but when she got home that is when she really felt it. Even now, it is not painful but it is something like say something crawling maybe. It is just kind of staying the same, and it has not spread anywhere else.'Caller adds that the only other thing she noticed was not where the shot was at but like, how can she explain it, on the left side. Nothing is wrong with her arm, no numbness or anything. On the left part, left arm, upper back it was kind of feeling funny. Her left arm was where the vaccine was. The patient underwent lab tests and procedures which included blood pressure measurement: 102/56, body temperature: 97.5 on an unknown date in 2021.Treatment was not taken, she is just drinking her soda. The outcome of events experienced rapid heart beat , upper back feeling funny was not recovered and unknown for other event.  No follow-up attempts are completed; information about lot/batch number cannot be obtained.
Pt. was accidently given wrong dose of influenza of the .25 ml and not .5 ml. New employee - correct dose will be given to the patient. No adverse reaction was noted.
"symptoms"/tested positive for covid; "symptoms"/tested positive for covid; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age (reported as 76 with no unit) received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date unknown), via an unspecified route of administration on 04Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was asking if she should get her second dose of vaccine on 25Jan2021, after receiving the first dose on 04Jan2021 and having symptoms and testing positive for COVID on 08Jan2021. The patient continued to have symptoms (unspecified) at the time of report. The patient was taking Tylenol for the symptoms. Outcome of the events was not recovered.  Information about lot/batch number has been requested.
Shortened my menstrual cycle; Brought a really heavy period; Had an earlier period, came six days earlier. Period came eight days after second shot; Chest Pain; Headache; Being tired; Cold after vaccine; Pain; wake up hot for six weeks; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (wake up hot for six weeks), NASOPHARYNGITIS (Cold after vaccine), POLYMENORRHOEA (Shortened my menstrual cycle), HEAVY MENSTRUAL BLEEDING (Brought a really heavy period) and MENSTRUATION IRREGULAR (Had an earlier period, came six days earlier. Period came eight days after second shot) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Apr-2021, the patient experienced NASOPHARYNGITIS (Cold after vaccine), PAIN (Pain), HEADACHE (Headache) and FATIGUE (Being tired). On an unknown date, the patient experienced FEELING HOT (wake up hot for six weeks), POLYMENORRHOEA (Shortened my menstrual cycle), HEAVY MENSTRUAL BLEEDING (Brought a really heavy period), MENSTRUATION IRREGULAR (Had an earlier period, came six days earlier. Period came eight days after second shot) and CHEST PAIN (Chest Pain). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, FEELING HOT (wake up hot for six weeks), NASOPHARYNGITIS (Cold after vaccine), POLYMENORRHOEA (Shortened my menstrual cycle), HEAVY MENSTRUAL BLEEDING (Brought a really heavy period), MENSTRUATION IRREGULAR (Had an earlier period, came six days earlier. Period came eight days after second shot), PAIN (Pain), CHEST PAIN (Chest Pain), HEADACHE (Headache) and FATIGUE (Being tired) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-149251, US-MODERNATX, INC.-MOD-2021-148821, US-MODERNATX, INC.-MOD-2021-149413, US-MODERNATX, INC.-MOD-2021-149360 (E2B Linked Report). This case was linked to MOD-2021-148762 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 01-Jul-2021: Added new event Chest pain.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-149413:Cluster case-2nd dose US-MODERNATX, INC.-MOD-2021-149360:Cluster case-1st dose US-MODERNATX, INC.-MOD-2021-148821:unknown female-1st dose US-MODERNATX, INC.-MOD-2021-149251:unknown female-2nd dose
Information has been received from a pharmacist concerning a patient who on an unspecified date was vaccinated with a dose of ZOSTAVAX (Merck) (dose, route, site and lot number not provided). Subsequently, two days after receiving ZOSTAVAX (Merck), the patient experienced rash. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Received Pfizer COVID vaccine. Got sick. Got better.; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 65 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date Feb2021 (Batch/Lot number: unknown) at the age of 65 years 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: ILLNESS (non-serious) with onset Feb2021, outcome "recovered" (2021), described as "Received Pfizer COVID vaccine. Got sick. Got better.". Therapeutic measures were not taken as a result of illness.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not test COVID-19 positive prior to vaccination. The patient had not been tested for COVID-19 since the vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Rash; Node in the injection site; Arm is swollen; Arm is swollen and sore; A spontaneous report  was received from a nurse concerning a 46-year-old, female patient who received Moderna's Covid-19 vaccine (mRNA-1273) and developed injection site nodule, peripheral swelling, pain in extremity and a rash.  The patient's medical history was not provided. Concomitant product use was not provided.  The patient received their first of two planned doses of mRNA-1273 (Lot number: 037KQ00) on 31 Dec 2020 in the left arm for prophylaxis of COVID-19 infection.   A nurse who is the patient called to report she received the Moderna COVID-19 vaccine on 31 Dec 2020. The next day, she noted a "node" at the injection site. The left arm was swollen and sore with rash.   Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not provided.   Outcome of the events, injection site nodule, peripheral swelling, pain in extremity and a rash, were considered unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
patient had blurred vision after receiving the vaccine, After about 2 hours it wore off and she felt better/ normal
This spontaneous report was received from an employee on 22JUN2018, 25JUN2018, 26JUN2018 and 27JUN2018. On 21JUN2018 the Environmental Health and Safety manager at a manufacturing plant reported an incident regarding a 41-year-old male who was immunized with ACAM2000 and experienced satellite lesions with cellulitis and eyelid soreness and swelling following ACAM2000 vaccination. On 11JUN2018, the male received vaccination with ACAM2000 at an occupational health clinic. On 16JUN2018 (day 5) the male spent the day fishing. He noted that the vaccination site bandage was filled with sweat; he removed the bandage and the 'pock ripped'. On 18JUN2018 (day 7) he returned for a post vaccination appointment with the physician. No issues were noted with the vaccination site. There was notable irritation of the skin where the bandage adhesive was in contact with the skin. On 19JUN2018 (day 8), the male noted small bumps around the vaccination site. On 20JUN2018 (day 9), the small bumps had escalated to small pocks. At that time he experienced discomfort of the lymph nodes under his arm. He reported the symptoms to his employer, and was told to follow up with the Occupational health clinic who had administered the vaccine. The patient did not follow up with health care at that time despite recommendations. On 21JUN2018 (day 10), he reported the issue to his employer's safety office. He was immediately sent to the Occupational health clinic for re-evaluation. At that time the area was re-dressed with teflex tape and he was prescribed KEFLEX and NAPROSYN. On 22JUN2018 (day 11), he consulted with the manufacturing facility safety officer. At that time, he was noted to have swollen and sore eyelids. The male reported that the bandage of the vaccination site had become loose. He also reported that he had been residing at a motel, and the bedding had been exposed to leaking bandage. He was sent back to the administering physician who sent him for follow up with an ear and eye specialist. At the ear and eye specialist, an eye culture was performed; the result was subsequently negative. He was prescribed antiviral drops as a precautionary measure. That evening he reported that he felt better and his eyes were fine. The administering physician reported the events to the local health department and CDC. Additional information received on 03JUL2018. The patient returned to work without further issues; all symptoms had resolved. Further information is not anticipated.
Body aches; Tongue turned white; Headaches; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body aches), TONGUE DISCOLOURATION (Tongue turned white), HEADACHE (Headaches) and PYREXIA (Fever) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027T21A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, the patient experienced PAIN (Body aches), TONGUE DISCOLOURATION (Tongue turned white), HEADACHE (Headaches) and PYREXIA (Fever). The patient was treated with PARACETAMOL (TYLENOL EXTRA STRENGTH) at an unspecified dose and frequency. On 17-Apr-2021, PAIN (Body aches), TONGUE DISCOLOURATION (Tongue turned white), HEADACHE (Headaches) and PYREXIA (Fever) had resolved.            No concomitant information provided. Treatment details included  extra Strength Tylenol
This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (employee received expired vaccine) and SUSPECTED COUNTERFEIT PRODUCT (Suspected Counterfeit Product) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination. No Medical History information was reported. On 18-Dec-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (employee received expired vaccine). On an unknown date, the patient experienced SUSPECTED COUNTERFEIT PRODUCT (Suspected Counterfeit Product). On 18-Dec-2021, EXPIRED PRODUCT ADMINISTERED (employee received expired vaccine) had resolved. At the time of the report, SUSPECTED COUNTERFEIT PRODUCT (Suspected Counterfeit Product) had resolved. No Concomitant medication information was reported. No Treatment medications were provided. Most recent FOLLOW-UP information incorporated above includes: On 20-Dec-2021: Follow up document contain non significant information.
Patient admitted to medical center for 2 episodes of vomiting blood.  He was started on a octreotide and pantoprazole gtt.  IV Ceftriaxone was started for SBP prophylaxis.  GI was consulted and patient was made NPO for EGD. EGD was negative with no bleeding source identified. Etiology of bleeding felt to be small bowel AVM vs gastropathy portal hypertension.  Patient had no further episodes of hematemesis and was hemodynamically stable. He opted to restart warfarin prior to discharge and planned for close follow up with his PCP. ED and hospital admission within 6 weeks of receiving the COVID vaccine.
This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX lot # L039092, expiration date 06-OCT-2017; lot # M009764, expiration date 23-FEB-2018 (exact dose, route of administration and anatomical location were not reported). There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
A few hours after I received the 2nd dose of the vaccine my whole body started itching. The itching was very bad. I went to the doctor the same day  and I was prescribed Valaciclovir ( 1gram 3xdays for 7xdays ). I broke out with blisters and sores from waist up. I had it on my arms, hands, neck, and face. The symptoms lasted about two weeks. I also had a headache.
Mom reported arm pain and swelling to right arm 4 days after receiving varicella # 2 vaccine, started as bump- increased after 2 days.
herpes zoster on upper right chest; groin, thigh, thoracic nerve pain; groin, thigh, thoracic nerve pain; groin, thigh, thoracic nerve pain; This is a spontaneous report from a contactable consumer via a Pfizer sales representative. A 50-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 21Jan2021 (Batch/Lot Number: FL3247) as UNKNOWN, SINGLE for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient developed groin, thigh, thoracic nerve pain on an unspecified date after the COVID vaccine. He later on developed herpes zoster on upper right chest with months of pain. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
pt recv vax & got sick, nauseated-vomiting, pain/muscle spasms in rt shoulder /arm, twitching in thumb, weak;loss of appetite, sore rt arm, pain into neck;weakness, sleeping a lot;
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Mar2021 as dose 1, single (Lot number: fr2613), in left arm, on 12Apr2021 as dose 2, single (Lot number: fr0150), in left arm and on 23Oct2021 as dose 3 (booster), single (Lot number: ff2593) at the age of 37 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Mild asthma" (unspecified if ongoing), notes: Mild asthma and no known allergies. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jun2022) Positive, notes: continued to test positive on home tests every two days; (Jun2022) Positive, notes: Symptoms and positive tests are continuing. Therapeutic measures were taken as a result of vaccination failure, covid-19 included Paxlovid started on 14Jun2022 and stopped on 19Jun2022.   Clinical course was reported as, after finishing the full five days of Paxlovid, patient felt great (no symptoms) but continued to test positive on home tests every two days.  No follow-up attempts are possible. No further information is expected.
I started itching crazy enough I couldn't sleep/I woke up still itching/It woke me up about 4 Am itching again/I could not go back to sleep it was so bad; I started itching crazy enough I couldn't sleep/I woke up still itching/It woke me up about 4 Am itching again/I could not go back to sleep it was so bad; I started itching crazy enough I couldn't sleep/I woke up still itching/It woke me up about 4 Am itching again/I could not go back to sleep it was so bad; This is a spontaneous report from a contactable consumer or other non hcp. A 66-years-old female patient received bnt162b2 (BNT162B2) formulation solution for injection, dose 1 via an unspecified route of administration at arm left on 01Mar2021 13:30 (Lot Number: EN6202 expiry date was unknown) as a single dose for covid-19 immunisation. Medical history included depression from an unknown date and unknown if ongoing, pain from an unknown date and unknown if ongoing. Concomitant medication(s) included bupropion hydrochloride taken for depression from 2019 to an unspecified stop date; duloxetine hydrochloride taken for pain from 2019 to an unspecified stop date; gabapentin taken for pain from 2019 to an unspecified stop date. The patient experienced she started itching crazy enough she couldn't sleep woke up still itching it woke me up about 4 am itching again she could not go back to sleep it was so bad on 01Mar2021, Consumer stated she got the first vaccine yesterday about 1:30 and probably at midnight she started itching crazy enough she couldn't sleep. She doesn't have a real obvious rash that she could see it on my skin. So, she took a 100 mg of Benadryl and finally went to sleep. She woke up still itching. She had to take some more Benadryl. She just wonder is that a normal reaction. When paraphrased the above concern, Consumer stated Yes. It woke me up about 4 Am itching again. So, had to get up and take more and she could not go back to sleep it was so bad. Consumer stated No, there isn't a doctor who told me to get it. So, they give the prescriptions at the pharmacy. Dose: Consumer stated No, it just says Pfizer. Consumer stated Because she 66 and at risk. Treatment: Consumer stated, Benadryl 50 mg twice. No follow-up attempts are possible. No further information is expected. Outcome of the events was not recovered.    No follow-up attempts are possible. No further information is expected.
RECEIVED ANTHRAX SHOT #05 21AUG04 NOTED "PANCAKE" SIZE SWELLING AT IMMUNIZATION SITE RIGHT ARM ON 22AUG04 WHICH OCCURED ON PREVIOUS 4 ANTHRAX SHOTS.  ON 24AUG04 NOTED SHORTNESS OF BREATH AND WHEEZING.  RELATES SOB/WHEEZING HAPPENED AFTER ANTHRAX SHOTS #3/4.  HAD HIVES AFTER SHOT #3.  PT DIDN'T REPORT THIS INFO TO MED FACILITY UNTIL NOW.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE CHEMOTHERAPY INDUCED PERIPHERAL NEUROPATHY, INIT NEUROPATHY
After injection significant amount of pain at injection site in upper shoulder throughout first day and night.  Woke me up multiple times during that first night, even after taking ibuprofen.  Pain again throughout the day on Thursday, taking ibuprofen. Noticed during the evening that the pain migrated from the shoulder muscle into the bicep muscle.  About 9pm when changing clothes Thursday evening caught site of left arm.  Bicep area red and inflamed, with swelling in shoulder and upper arm, as compared to right arm.  Red areas very hot to the touch.  Had taken Zyrtec already both the day of the injection and on Thursday, due to allergies.  Called the 24 hour nurse line associated with my health insurance to ask what to do.  The nurse recommended I seek medical treatment within one hour.  As I write this on Saturday evening, 3/20, about 9:45pm, the reaction has subsided somewhat, but there is still some swelling and redness in my upper arm.
Rash; Lightheadedness; Fatigue; This case was reported by a consumer via interactive digital media and described the occurrence of rash in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st April 2021, the patient received Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced rash, light headedness and fatigue. On an unknown date, the outcome of the rash, light headedness and fatigue were unknown.   It was unknown if the reporter considered the rash, light headedness and fatigue to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported, but was selected adult as per vaccine indication. 48 hours before reporting time, the patient had received dose of Shingrix and just before reporting, experienced rash, light headedness and fatigue. No other information was reported.