chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a licensed practical nurse referring to a patient of unknown age and gender. On an unknown date the patient was inadvertently vaccinated with a dose of VARIVAX (lot # L020004 with an expiration date of 02-JUN-2017, dose and route unknown) and also vaccinated with a dose of PROQUAD (lot# L030584 with expiration date of 10-FEB-2017, dose and route unknown). No adverse effects were reported. Additional information has been requested.
Narrative:  COVID infection after completion of COVID vaccine series: 04/23/2021 COVID vaccine dose #1 (pharmacy) 05/14/2021 COVID vaccine dose #2 (pharmacy) 07/15/2021 Pt reported onset of cough, sore throat, and fatigue 07/17/2021 Pt presented to ED c/o continued symptoms. Pt prescribed benzonatate for cough and mild pulmonary edema. 07/17/2021 COVID positive per nasopharyngeal swab 07/18/2021 Pt reported onset of mild SOB and HA 07/19/2021 Pt reported onset of fever and chills with sweating as well as rhinorrhea 07/20/2021 Pt reported feeling better 07/22/2021 Pt's daughter reported that he had increased fatigue and sleeping, but improvement of other sx 07/23/2021 Pt reported improvement of sx. Still experienced some rhinorrhea. 07/24/2021 Pt reported improvement of sx 07/25/2021 Clinical resolution of COVID infection per CDC guidelines. Pt's spouse and daughter COVID positive and s/sx started after pt. 07/29/2021 COVID positive per nasopharyngeal swab conducted after positive screening respond (close contact with COVID positive case)
Patient stated she was having heartburn and right armpit soreness/pain about 3 to 4 minutes after injection. She waited about 15 minutes and the heartburn went away but she is still having armpit pain. It is staying the same, not getting better or worse.
sleepy very very sleepy; sore arm; extreme fatigue and tiredness; irritating right now; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 12Feb2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included Bnt162b2 (First shot on 22Jan 2021 after which they experienced a sore arm), administration date 22Jan2021, for Covid-19 immunisation. The following information was reported SOMNOLENCE (non-serious), outcome unknown; PAIN IN EXTREMITY (non-serious), outcome unknown; FATIGUE (non-serious), outcome unknown; IRRITABILITY (non-serious), outcome unknown.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected. Linked Report(s): US-PFIZER INC-2021224012 same reporter, drug, dose, event, and different patient.
After both doses of the vaccine I developed scratches on my left shoulder. The scratches look as if I was scratched by a cat and they burn. The first set of scratches developed within an hour of receiving the first dose of the Pfizer vaccine. At that time there we?re only 2 scratches, which went away after 8 days. After receiving my second dose of Pfizer however I again noticed the markings on my left shoulder within an hour of getting the vaccine. This time they started off looking like indentations in my arm, similar to when a sleeve leaves marking on the arm from being too tight (which was not an issue). Then 3 days later the markings developed into several deep scratches, again similar to how cat scratches would look. The scratches are painful (the year burn).  In addition to the scratches I have also noticed a strong increase in my depression since receiving the first dose of the vaccine.
Pt recvd 1st dose of Hep B vax on 5FEB91 & on 28FEB91 exp soreness in back & lt leg, h/a & fatigue; joints felt swollen & was difficult to walk; 5MAR91 seen by MD w/pain in feet, hips & back as well as achiness & stiffness;
Fever 105.0, adenopathy (neck), angioneurotic edema, asthma, marked alteration in LOC, 2 convuls, short term hearing loss.
This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Hot to the touch around injection site), EXTRA DOSE ADMINISTERED (Received a third dose), FATIGUE (Very tired), VACCINATION SITE INDURATION (Hard, the size of a silver dollar) and PYREXIA (Tiny fever) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included COPD, Heart disorder, Blood pressure high, Asthma and Overweight. On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Feb-2021, the patient experienced PYREXIA (Tiny fever). 05-Feb-2021, the patient experienced VACCINATION SITE PAIN (Sore at the injection site). On 04-Aug-2021, the patient experienced EXTRA DOSE ADMINISTERED (Received a third dose). On 05-Aug-2021, the patient experienced FATIGUE (Very tired). On 06-Aug-2021, the patient experienced VACCINATION SITE WARMTH (Hot to the touch around injection site) and VACCINATION SITE INDURATION (Hard, the size of a silver dollar). The patient was treated with NAPROXEN SODIUM (ALEVE) for Fever and Injection site pain, at an unspecified dose and frequency. On 06-Feb-2021, PYREXIA (Tiny fever) had resolved. On 04-Aug-2021, EXTRA DOSE ADMINISTERED (Received a third dose) had resolved. On 05-Aug-2021, FATIGUE (Very tired) had resolved. At the time of the report, VACCINATION SITE WARMTH (Hot to the touch around injection site), VACCINATION SITE INDURATION (Hard, the size of a silver dollar) and VACCINATION SITE PAIN (Sore at the injection site) outcome was unknown. No concomitant drugs were reported. Most recent FOLLOW-UP information incorporated above includes: On 04-Aug-2021: Follow up information included new event (Extra dose administered) added. On 06-Aug-2021: Follow up information included new events added.
She had a fever of 103, fatigue, runny nose, cough, loss of appetite, irritable and cranky. Her symptoms started on 12/8/22 and lasted through 12/14/22. She still has a little cough, but she is doing much better. She tested positive for COVID-19 and Influenza A on 12/13/22. She was not prescribed any medication.
Raging sore throat, fever, chills, muscle aches, headache, bone pain, like I was hit by a truck, treatment was rest, fluids, throat spray, naproxen sodium.
tachycardia that occurs intermittently and worsening left ear tinnitus that was present prior to the vaccine
Two days after receiving the vaccine, patient's arm became red, swollen, and itchy. Patient was seen by her primary care provider and prescribed a steroid dose pack to treat an allergic reaction. Patient's mother stated that patient's arm was better soon after starting dose pack and patient is doing well.
I awoke with uncontrollable shaking, lasting approx. 4 min.  Internal shaking followed for approx. 15 min.  Body aches, dry mouth, low grade fever and headache followed over the next hour.  Light headedness and general malaise lasted for approx. 12 hours.
Received 1st dose / between September and October, 2020; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose between September and October 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were reported as follows: The age at vaccination was not applicable. The reporter stated the patient was 65 years and older but did not specify. Till the time of reporting the patient didn't receive the 2nd dose which led to incomplete course of vaccination. No further details of patient or vaccine were provided. No further details were reported. The reporter did not consent to follow up. This is 1 of the 5 cases, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021102194:Same reporter US-GLAXOSMITHKLINE-US2021102195:Same reporter US-GLAXOSMITHKLINE-US2021102197:Same reporter US-GLAXOSMITHKLINE-US2021102198:Same reporter
INJECTION SITE REACTION WITH REDNESS, SWELLING, BRUISING IN TWO SITES, HAD LOW GRADE FEVER IN FIRST 24 HOURS OF SHOT BUT HAS DISAPPEARED SINCE, RED REACTION IS STILL WARM ONE WEEK POST VACCINE
Red macular rash on face, backs of hands, neck and shoulders. Note: I do not believe this is a vaccine reaction; I believe it is an exacerbation of impetigo.
Patient had been given a Moderna 1st booster dose on 11/17/21. This was determined by health department to be an invalid dose. We recalled the patient for revaccination, not realizing she had received a second booster on 5/9/22. We gave her a dose of Moderna on 7/29/22 which is earlier than the 4 months recommended. No side effects noted. I informed the patient of the error today, and she has a slightly sore arm now 3 days post vaccination. We have retrained our staff regarding appropriate Moderna dosing intervals.
Immediately after the client got vaccinated, the client had blood squirting out at the vaccine site. The client, who admits to being "squeamish", look at the blood and states that "immediately her vision got blurry".  The client worked her way from the chair down to the floor and laid down. After laying down, the client states "vision is not blurry anymore" and that "it lasted about 30 seconds".  The client reported feeling anxious after medical staff began surrounding her.
2 days after flu vaccine developed itching, burning and blisters to L scalp. Diagnosed with herpes zoster.
neuropathy of the feet; sore arm; This is a spontaneous report from Pfizer-sponsored programs, Pfizer RxPathways and Pfizer Patient Assistance and Savings Program for Lyrica and Lyrica CR, from a contactable consumer. This consumer reported similar events for two patients. This is the first of two reports.   A 74-year-old male patient received BNT162B2, via an unspecified route of administration in Mar2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The medical history and concomitant medications were not reported. The patient previously took pregabalin (LYRICA) for neuropathy of feet. The reporter stated during inbound call, the patient received vaccine back in Mar2021 and it had worked great. The patient had a really sore arm on an unspecified date, reported "they stick with a big needle". It worked out great for the patient. The patient had neuropathy of the feet and he needed medicine pregabalin (LYRICA). The outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021829969 same reporter, different patients, same drug
vertigo; vomited; felt weak in the knees like she could not support herself; neck pain; lungs hurt to breathe; weakness; flu symptoms; fever; chills; shoulder blade pain; headache; This spontaneous case was reported by a consumer and describes the occurrence of BALANCE DISORDER (felt weak in the knees like she could not support herself), VERTIGO (vertigo), NECK PAIN (neck pain), PAINFUL RESPIRATION (lungs hurt to breathe) and ASTHENIA (weakness) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 20B21A and 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Pneumonia (double pneumonia).   On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Apr-2021, the patient experienced NECK PAIN (neck pain), PAINFUL RESPIRATION (lungs hurt to breathe), ASTHENIA (weakness), INFLUENZA (flu symptoms), PYREXIA (fever), CHILLS (chills), ARTHRALGIA (shoulder blade pain) and HEADACHE (headache). On 03-Apr-2021 at 1:00 PM, the patient experienced BALANCE DISORDER (felt weak in the knees like she could not support herself). On 04-Apr-2021, the patient experienced VERTIGO (vertigo) and VOMITING (vomited). On 03-Apr-2021, BALANCE DISORDER (felt weak in the knees like she could not support herself), NECK PAIN (neck pain), PAINFUL RESPIRATION (lungs hurt to breathe), INFLUENZA (flu symptoms), PYREXIA (fever), CHILLS (chills), ARTHRALGIA (shoulder blade pain) and HEADACHE (headache) had resolved. On 04-Apr-2021, VOMITING (vomited) had resolved. On 05-Apr-2021, VERTIGO (vertigo) had resolved. On 06-Apr-2021, ASTHENIA (weakness) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Apr-2021, Blood pressure measurement: 142/96mmhg (High) Her blood pressure which was normally 110/79mmHg was up to 142/96mmHg for day and half ..         No concomitant drug information was provide by reporter.  No treatment medication was provided by you.   Most recent FOLLOW-UP information incorporated above includes: On 28-Jul-2021: Follow up received contains no significant information.
ADULT OBSTRUCTIVE SLEEP APNEA, MILD 2/24/2023 & 2/23/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Fatigue. Joint pains. Muscle pains. Numbness and tingling of hand/feet. Fever 101.2 . Headache
O2 levels dropped below 80; Supposed to get second dose on 18MAR2021. Had covid. Outside of 42 day mark; covid-19; This spontaneous case was reported by a consumer and describes the occurrence of OXYGEN CONSUMPTION DECREASED (O2 levels dropped below 80) and COVID-19 (covid-19) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event. On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Feb-2021, the patient experienced COVID-19 (covid-19) (seriousness criterion medically significant). On 18-Mar-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Supposed to get second dose on 18MAR2021. Had covid. Outside of 42 day mark). On an unknown date, the patient experienced OXYGEN CONSUMPTION DECREASED (O2 levels dropped below 80) (seriousness criterion medically significant). On 18-Mar-2021, PRODUCT DOSE OMISSION ISSUE (Supposed to get second dose on 18MAR2021. Had covid. Outside of 42 day mark) had resolved. At the time of the report, OXYGEN CONSUMPTION DECREASED (O2 levels dropped below 80) and COVID-19 (covid-19) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. On 8MAR2021 he went into the hospital for his covid-19 symptoms and was given "the bag of tricks" describing a clinical trial antibody treatment. He was not sure if he received the placebo or experimental treatment. His O2 levels had dropped below 80 with his covid-19. He was given oxygen, zinc, and vitamins which he had been using. He also has been using "cough pills," and an inhaler. His O2 has now improved to 96-98 and he is now "covid free.; Sender's Comments: This case concerns a 67-year-old male hospitalized with serious unexpected events of COVID-19 and hypoxia (oxygen saturation decreased), and nonserious unexpected product dose omission issue. event resolved. Based on 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.
3/27/2021: generally fine - slight tingling in both hands/arms following vaccine; skin felt hot like a sunburn on both arms about an hour after. Carried on with my day like nothing happened.  3/29/2021: (1) Uncharacteristic, debilitating headaches began started around mid-afternoon (ish) and continued on/off - occurred approximately 5-7x and largely tapered off by 4/9/2021.  (2) extreme soreness continuously occurring on the upper right side of my back b/w the spine and scapula. I could barely move it most days. Has gotten slightly better beginning 4/12/2021, but remains unresolved as of this report.  4/15/2021: woke up with severe headache again.
This spontaneous report was received from a Nurse refers to a 2 year old patient. On 21-APR-2014 the patient was vaccinated with expired (Oka/Merck) VARIVAX lot # H007170 (Expiry: 22-MAR-2014) (dose, route and frequency were not reported) in error. No adverse effect was reported. No PQC reported. No other information was provided. Additional information has been requested.
Information has been received from a medical assistant referring to a patient of unknown age and gender. Information of concomitant therapy, pertinent medical history and drug reactions/allergies was not reported. On 05-NOV-2018, the patient was vaccinated with improperly stored VAQTA (lot # R013858, expiration date: 12-JUN-2019, strength, dose, frequency and route were unknown) for prophylaxis (Incorrect product storage). No adverse effects were reported. The vaccines were exposed to temperature of 47 Fahrenheit (F) for 37 minutes. The temperature excursion was detected by a data logger. Previous temperature excursions were reported as 47 Fahrenheit (F) for 50 minutes. The case was one of the cases received from the same reporter. Sender's Comments: US-009507513-1901USA004786.
Pt recvd 1st vax on 29AUG90.The MMR II vial was mixed w/ diluent intended for use w/ HIB Conj vax.
Patient is aged 19. Received adult dose of Hepatitis B as first dose in the series. No adverse events between dose 1 and dose 2. Discovered at time of second injection. Patient received age-appropriate dose for dose 2.
Tired; Pain in injection site; Chills; Dizziness; Headache; Runny nose; Hot flashes; Acne; Increase sense of smell; Pain in lungs when breathing; Racing heart; Vertigo; Tinnitus; Joint pain; Cough; Stuffy nose; Blurry vision; Anxiety; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown) via an unspecified route of administration in the left arm on 19Mar2021 at 10:00 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history included kidney disease and hypothyroid. The patient did not have allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received medications within 2 weeks of vaccination included lisinopril (MANUFACTURER UNKNOWN), PAXIL, CLARITIN and SYNTHROID, all for unspecified indications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. On 19Mar2021 at 1400, the patient was tired and had experienced pain in injection site, chills, dizziness, headache, runny nose, hot flashes, acne, increase sense of smell, pain in lungs, when breathing, racing heart, vertigo, tinnitus, joint pain, cough, stuffy nose, blurry vision and anxiety. The patient did not receive any treatment for the reported events. Adverse events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events tired, pain in injection site, chills, dizziness, headache, runny nose, hot flashes, acne, increase sense of smell, pain in lungs, when breathing, racing heart, vertigo, tinnitus, joint pain, cough, stuffy nose, blurry vision and anxiety were resolving at the time of this report.  Information on lot/batch number has been requested. No further information is expected.
Patient received a quad flu shot at a pharmacy, within minutes became weak and dizzy, followed with nausea and lip tingling, also tongue numbness, feeling of passing out. Pt drove herself and 8 month old baby to an ER who would not listen any information related to the shot she just received, she was given 2 XANAX and sent home. The patient became sicker with a high fever and nausea vomiting and chills, all of her skin hurt. The pharmacy was made aware of the problem. She also had a hive at the injection site. She was put into a room with her baby and the door to the room shut, alone.
HAD INJECTED VACCINE THAT HAD TEMPERATURE EXCURSIONS BUT WERE OKAYED; INCORRECT PRODUCT STORAGE; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. 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, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The drug was associated with Medication error. The batch number was not reported and has been requested. No concomitant medications were reported. On DEC-2021, the patient experienced had injected vaccine that had temperature excursions but were okayed, and incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the had injected vaccine that had temperature excursions but were okayed and incorrect product storage was not reported. This report was non-serious.
This spontaneous report as received from a other health professional refers to a patient of unknown age. The patient was vaccinated with lot # (666597/0768Z) dose, 1, 1 DF GARDASIL on 06-NOV-2012. No other co-suspects were reported. No concomitant medications were reported. On 06-NOV-2012 the patient experienced expired vaccine used, 1 day after onset of therapy. No treatment information was reported. Expired vaccine used is not related to GARDASIL. (Additional information has been requested. / Additional information is not expected.)
This spontaneous report as received from a office manager refers to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, drug reaction/allergies and concomitant medications was not reported. On an unknown date, a year later, the patient was vaccinated with GARDASIL 9 (lot number, expiration date, dose, route of administration and frequency were not reported). No adverse effects were reported. There was no product quality complaint. Additional information his not expected because the reporter did not consent to contact with the patient's physician.
no adverse event; She reported that on 21SEP2021, VARlVAX that expired on 16SEP2021 was administered to a patient; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, concomitant therapies, and drug reactions/allergies were not reported.  On 21-SEP-2021, the patient was vaccinated with an expired varicella virus vaccine live (Oka/Merck) (VARIVAX) (0.5 mL, lot # S028926 has been verified to be a valid lot number, expiration date was 16-SEP-2021; strength, route of administration, and anatomical location were not reported) for prophylaxis (expired product administered). It was reconstituted with not expired sterile diluent (manufacturer unknown) (0.5 mL, lot number T011343 has been verified to be a valid lot number, expiration date was 06-NOV-2022; strength and route of administration were not reported). It was reported that varicella virus vaccine live (Oka/Merck) (VARIVAX) had not experienced a temperature excursion. The reporter was provided with the expired supported disclaimer. No other adverse events were reported.