chrisvoncsefalvay/vaers-outcomes huggingface dataset:
as we vaccinated a week later we both my wife and I both got COVID; This is a spontaneous report from a contactable consumer (patient's husband). This consumer reported similar event for two patients.  This is the second of two reports.  A female patient (wife) of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot and expiry were not reported), via an unspecified route of administration on 27Jan2021 as 1 st dose, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The husband stated that, "as we vaccinated a week later we both my wife and I both got COVID" on 03Feb2021. The seriousness was unspecified. They were told that they couldn't go back for our second shot for 90 days which they just completed on this morning for the shot. The husband asked if that should be their second shot or should they stop the process over again with the first shot. The outcome of the event was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021530683 same reporter/drug/event, different patients
Hospitalized after syncope. mild symptoms of COVID, NOT hypoxic on admit to hospital.
PATIENT WAS GIVEN PNEUMOVAX 3/19/2010 @ 9:45 AM. AT 9:50 AM, PATIENT C/O "FEELING FUNNY" AND LOST CONSCIOUSNESS FOR 2 MINUTES. AFTER RECOVERING, SHE WAS OBSERVED FOR 2 HOURS AND GIVEN IV FLUID.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021 at 2:16 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 12-Feb-2021 at 2:16 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 60.46.  No concomitant medications were reported.  Vial was moved to fridge on 09-Feb-2021. Product moved to clinic on 12-Feb-2021. Batch number 031L20A underwent temperature excursion on 12-Feb-2021 with temperature 35 degrees Fahrenheit from 10 AM to 11 AM. Beyond use date for the vial was reported as 10-Mar-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  No treatment medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).
chief complaint of lightheadedness and an upset stomach onset this morning. Patient states that yesterday he had his second Pfizer COVID shot. Afterward he felt fine but this morning woke up with an upset stomach, lightheadedness and felt clammy. He describes the upset stomach as feeling hungry. The lightheadedness is described as, "my stomach felt off, which made me feel sick and off".  His wife called EMS for the patient to be evaluated as he has a cardiac history. At this time he has no lightheadedness but his stomach is still upset, like "I need to eat".  Received pepcid and NS 1000 mL
I was covid positive one month prior to vaccine.  I woke up the morning after the vaccine with a fever, chills, muscle aches and my injection site in pain.  After one day I felt better, but my arm still hurt.  I hurt for 4 days and spread down my arm and into my ribs.
Expired vaccine (TDaP) administered to patient. Patient has been contacted and no reaction occurred. Will re-vaccinate patient.
Felt blood pressure drop, then increase with high pounding heart rate, cold hands and shaking a little.  The nurses checked my heart rate, O2 and BP until it normalized.
Systemic: Fainting / Unresponsive-Mild, Additional Details: Pt has history of fainting with vaccinations.  She fainted immediately following injection and was moved to the floor by her boyfriend.  She was fully recovered approximately 20 minutes later.
This spontaneous report as received from a physician, concerns to a 15 year old female patient enrolled in a market research. The patient  did not have concurrent conditions, medical history, drug reactions or allergies. On an unknown date in 2015, after being vaccinated with the 3rd dose of GARDASIL (strength, dose number, anatomical location, lot #, expiry date, and route of administration were not provided), the patient fainted (10 minutes after vaccination), however, she did not lose consciousness. It was reported that the patient did not faint with prior vaccination of GARDASIL. The patient did not take any concomitant medication. No laboratories were performed. There was no product quality complaint involved. The outcome of the event was reported as recovered and resolved with sequelae. The relatedness between vaccination with GARDASIL 9 and syncope was not reported. Additional information has been requested.
sore arm; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.   Treatment information was not provided.
Symptoms began the morning after shots 1 and 2. They got worse throughout the morning. They began with fatigue, headache and chills. Then a fever and joint/body aches and pains. After shot two I have a red spot near injection site that is hard and itchy.
4/22/21 was second dose of pfyzer vaccine chronic Diarrhea started 4/24/21. Chronic diarrhea has been steady until present. Only thing that has helped was the BRAT diet and the clear liquid diet. I am constantly having to go the restroom and continue to have loose stools with yellow liquid in the toilet bowl.  I sometimes have had to poop 4 times in one day.
Botox cosmetic not working; maybe using botox off label; This is a spontaneous report from a contactable consumer or other non-HCP. A 41-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single and received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunization; botulinum toxin type a (BOTOX), via an unspecified route of administration from an unspecified date (Batch/Lot number was not reported) and ongoing, at unspecified dose for an unspecified indication. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced Botox not working for her. Patient stated that she is the injector, and she has been doing it on herself for 13 years. Two recent administrations in a row resulted in Botox not working for her; dates of administration not reported. She said that the second injection that resulted in Botox not working was 6 weeks after the first. She said she may be using the Botox off-label because she has a "tall, strong" forehead, so she injected 22 units into her forehead. She injected a total of 100 units from her forehead to her collarbone to her platysma. She clarified that muscles she injected included her forehead, her glabella, her eyes, her DAO's (depressor), her chin, and her platysma. She said in 6 weeks after the injection she had full movement. She stated she injected herself today again (22Jul2021). Results of the 22Jul2021 injection were not reported. She states she heard that if you inject Botox for a long time, that eventually it stops working, and she was worried that was what was happening. She has been injecting Botox long enough and she has not noticed that happening. She is wondering if this is a "lot number thing". She also asked if it's "a thing" for Botox to stop working. Patient stated she has not had a positive COVID diagnosis in the past and she confirmed she has had the COVID vaccine, both doses, Pfizer. The outcome of events was unknown.  Follow-up attempts are completed. No further information is expected.
Pt received Polio vaccine in R thigh and Dtap in L thigh at 11:30am. Mother gave Ibuprophen and child took nap. Child complained of leg pain when he woke up. Also complained of feeling like he had food in his throat. Bilateral swelling of thighs. Seen in ER given PO Benadryl and Prednisone.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. An 80-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Jan2021 as dose 1, single (Lot number: EL9263), in left arm, on 22Feb2021 as dose 2, single (Lot number: EL9265), in left arm, on 29Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 05May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 80 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Mitral valve replacement" (unspecified if ongoing); "Osteoporosis" (unspecified if ongoing); "Glaucoma" (unspecified if ongoing). The patient had no known allergies. Concomitant medication(s) included: WARFARIN; VITAMIN D; ASPIRIN 81. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient was a little tired the first shot. No reaction after the other three. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
03/07/21 - after 4 days with no irritation at injection site, arm became red, swollen, hot, amd itchy.  Also experienced high heart rate, amd heartburn. No fever.  03/02/21 - initial side effects severe fatigue, severe joint pain throughout entire body, minor nausea,
Palpitations and anxiety after second dose of Pfizer-BioNTech COVID-19 vaccine 0.3 mL in left deltoid.  Monitored vitals, which were stable. ECG was normal. Patient reassured, and patient stated that her anxiety was much better and felt that she didn't need to go to the ED. Patient instructed to call or return to ED if symptoms worsened. Patient has a history of anxiety and panic attacks, and felt that the reaction was related to this.
8/7/15 Localize reaction to RLE edema and redness of over 4cm in diameter. Prescribed KEFLEX parents instructed to use BENADRYL, MOTRIN, was instructed to take to ER if worsens over the weekend.
(OMIC) 53 year old healthy male was given two vaccines (influenza and Dtap) on 10/25/2006. He developed a severe headache on 10/29. The headache persisted and he subsequently developed diplopia on 11/1. He had mild nausea, photophobia, neck tightness and fatigue. He had a normal.  Confirmed with reporter that Tdap (Adacel) was given, not Dtap. MR received revealing a 53 year old who was seen 3 days s/p Tdap and flu vax. with c/o right sided neck tightness, photophobia, nausea  and headache.  Pt. developed diplopia 3 days post vax.  PE: WNL with the exception of measurements of the degree of deviation of his eyes c/w a right 4th cranial nerve palsy upon opthalmologic exam. Using Motrin and Tylenol for h/a.  DX: New onset right 4th cranial nerve palsy associated with flu shot and headache.
Very swollen and tender lymph nodes under left arm pit; Very swollen and tender lymph nodes under left arm pit; This is a spontaneous report from a contactable consumer (Patient). A 42-year-old female patient (non-pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EL9262), dose 1 via an unspecified route of administration, administered in left arm on 11Feb2021 at 14:30 (at the age of 42-year-old) as a single dose for Covid-19 immunisation. Medical history included crohn's disease from an unspecified date. The patient's concomitant medications were not reported. The patient previously took doxycycline, sulfamethoxazole trimethoprim (BACTRIUM DS), levofloxacin (LEVAQUIN) and experienced allergies. The patient did not receive any other vaccines in 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient was not tested for COVID-19. The patient experienced very swollen and tender lymph nodes under left arm pit on 14Feb2021 at 08:00 am. No treatment received for events. Outcome of the events was recovering.  Follow-up attempts are completed. No further information is expected.
Patient had a red, warm area about one inch below flu vaccine area. Advised her to contact PCP if continues to be bothersome or painful.
3 persons felt dizziness after vaccination; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (3 persons felt dizziness after vaccination) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (3 persons felt dizziness after vaccination). At the time of the report, DIZZINESS (3 persons felt dizziness after vaccination) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant and treatment medication was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-089271, US-MODERNATX, INC.-MOD-2021-089661 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-089271:Reporter case US-MODERNATX, INC.-MOD-2021-089661:Wife case
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE ACUTE PULMONARY EMBOLISM HYPOXEMIA
Tingling; Numbness; Itched; Pain in her arm; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Tingling), HYPOAESTHESIA (Numbness), PRURITUS (Itched) and AXILLARY PAIN (Pain in her arm) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.  On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On an unknown date, the patient experienced PARAESTHESIA (Tingling), HYPOAESTHESIA (Numbness), PRURITUS (Itched) and AXILLARY PAIN (Pain in her arm).   At the time of the report, PARAESTHESIA (Tingling), HYPOAESTHESIA (Numbness), PRURITUS (Itched) and AXILLARY PAIN (Pain in her arm) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.  Concomitant product use was not provided by the reporter. No treatment information was provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
On Feb 24th, 2023, I started with cough, running nose and congestion, and it kept getting worst. I had things to do, on Monday March 6th I went to Urgent Care. I had a COVID-19 Test and a Flu test and both were negative; they gave me antibiotic I took antibiotic for 10 days and was diagnosed with Bronchitis. Then I went to see my doctor because I continued with running nose, deep cough, she prescribed medicine, an inhaler and cough medicine. I got better after that, but the cough went to allergies, she thinks I have RSV.
Extremely  Severe headache, extremely severe body aches and fast heart rate at rest has high as 133 symptoms didn?t start until approximately 7 pm day of injection continued throughout the night and into the next day
Developed a raised red rash at injection site. It is itchy and about 7 inches in diameter
About a third of the dose spilled out; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete dose administered in a 53-year-old female patient who received Herpes zoster (Shingrix) (batch number P39GK, expiry date 9th June 2023) for prophylaxis.   On 15th April 2022, the patient received the 2nd dose of Shingrix. On 15th April 2022, unknown after receiving Shingrix, the patient experienced incomplete dose administered. On an unknown date, the outcome of the incomplete dose administered was unknown.       Additional Information: GSK Receipt Date: 15th Apr 2022 Reporter's Comments: The pharmacist reported she was administering a dose of Shingrix vaccine to a patient, but about a third of the dose spilled out. This was the patient's second dose in the series. At the time of reporting, repeat dose had not been performed. The reporter consented to follow up. Additional Supportive Information: It was stated that a third of the dose spilled out, which led to incomplete dose administered.
pt recv vax 3APR94 & 7APR94 exp a sore throat & devel a low grade fever & a cough; presented to MD; PE revealed enlarged tonsils, enlarged & tender lymph nodes & a sl enlarged liver; 8APR94 pt cont to feel ill & had a dec appetite;
Tingling sensation, sharp pins and needles sensation to hands and feet. Burning sensation to feet. Symptoms began 9/16/2021. No treatment occurred. Symptoms still present two months later, but diminished.
swollen armpit; This spontaneous case was reported by a pharmacist and describes the occurrence of PERIPHERAL SWELLING (swollen armpit) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (swollen armpit). At the time of the report, PERIPHERAL SWELLING (swollen armpit) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Treatment information was not provided.
57-year-old received Fluzone HD which is intended for 65+ age group - no side effects
COVID positive after receiving vaccine; high fever; chills; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID positive after receiving vaccine), PYREXIA (high fever), CHILLS (chills) and FATIGUE (fatigue) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007MZ0A) for COVID-19 vaccination.     Concomitant products included ACEBUTOLOL, DESVENLAFAXINE SUCCINATE (PRISTIQ), ESTROGENS CONJUGATED (PREMARIN), PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE (MIRAPEX) and HYDROCHLOROTHIAZIDE (THIAZIDE) for an unknown indication.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced PYREXIA (high fever), CHILLS (chills) and FATIGUE (fatigue). On an unknown date, the patient experienced COVID-19 (COVID positive after receiving vaccine). At the time of the report, COVID-19 (COVID positive after receiving vaccine), PYREXIA (high fever), CHILLS (chills) and FATIGUE (fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 antibody test: unknown (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications provided by the reporter.
approx 10days p/vax pt devel migratory proximal limb girdle pain.  sx mimic  polymyalgia rheumatica &  early inflammatory arthritis. prolonged sx despite treatment.  Non drug allergies. The patient has a prostate problem (nos) for which he takes Proscar. The patient received the first and second .5 ml IM doses of LYMERIX on 13-Apr-99, and 13-May-99, respectively, for prophylaxis of Lyme disease. 10 days after dose 3, on 23-May-99, and 40 days after dose 1, he experienced joint stiffness, arthralgias, and myalgias. He was diagnosed with polymyalgia rheumatica. The patient was first seen by physician on 01-Jul-99, and was treated with steroids (nos) and NSAIDS (nos). He was subsequently treated with PREDNISONE 95 mg currently) and VIOXX (12.5 mg currrently). Physician reported that the patient was doing better. The most recent information, received on 27-Sep-99, reports the condition of the patient is not yet resolved.
This spontaneous report was received from a registered nurse who was also the office manager and refers to a 18-year-old female patient with none pertinent medical history and none drug reactions or allergies. The patient's concomitant therapies included ethinyl estradiol, ferrous fumarate, norethindrone acetate(LO LOESTRIN FE). On 19-APR-2017, the patient was vaccinated with the first dose of GARDASIL 9, intramuscularly (dose, anatomical location, lot number and expiration date were not reported) for vaccination. Then on 09-AUG-2017, the patient was vaccinated with the second dose of GARDASIL 9 as the same dosage regimen above described. On 09-AUG-2017, the patient fainted shortly after receiving the GARDASIL 9 and was in a catatonic state for one minute (syncope and catatonia). Additionally, the patient experienced tonic-clonic movements for one minute. The only treatment that the patient received for this reaction was an unknown person holding her legs down during the event to prevented injury in the patient. The patient sought medical attention as the event occurred at the office visit, no laboratories diagnostics were performed. At the time of the report, the patient fully recovered on the same date before leave the office. The physician had not decided whether to finished the 3 dose series for the patient. Upon internal review, tonic clonic movements was determined to be medically significant event.