chrisvoncsefalvay/vaers-outcomes huggingface dataset:
had the first dose of the Pfizer COVID-19 vaccine on 07Apr2021 and on Saturday of that week, she tested positive for COVID-19; really high fever; she was sick with Covid; tired; back ache; This is a spontaneous report from a Pfizer  COVAX  support. A 44-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for Injection, Lot Number: EW0156), via an unspecified route of administration, administered on Arm Right at the age of 44-year-old on 07Apr2021 11:30 as single dose for covid-19 immunization. Medical history (including any illness at time of vaccination) and Family Medical History Relevant to adverse event was reported as none. There was no adverse event following prior vaccinations. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. Reporter stated that she got the vaccine on Wednesday and by Friday or Saturday, she was sick with Covid and stated it was kind of the perfect storm, being exposed at the same time as she got the first vaccine. Reporter stated she doesn't have prescribed Healthcare Professional and confirms it was the Pfizer Covid Vaccine she received. Reporter stated her first dose was given on Wednesday, 07Apr2021 and by Saturday she had COVID. On 09Apr2021(Friday), she started feeling kind of tired, rundown and she stated that she was thinking it might be the vaccine side effect at first, she wasn't super concerned but by Saturday morning, she had a very high fever and tested positive on Saturday morning. She confirmed that she had the rapid test positive on 10Apr2021. Reporter stated that the tiredness and fever, took her a solid, close to 7 days to recover and the tiredness took her between 7 and 9 days to feel better. She stated that she would say some of the tiredness and backache actually started earlier in the week as she had a busy week, she was done a lot of stuff, staying up late at night. She stated that she was tired, her back hurt a little bit, because she was being physically active, but looking back she was probably having mild symptoms perhaps prior to that Friday and stated at the time she was worked too hard, done too much, staying up too late, all those things probably were very mild symptoms even on the Wednesday when she got the shot and by Friday she felt like okay, she was tired. She wanted to know if she can get the second dose of the Pfizer COVID-19 vaccine and to know if there is a timeframe in getting the second dose. The patient underwent lab tests and procedures which included sars-cov-1 test positive: positive on 10Apr2021. The patient did not visit to Emergency Room/ Physician Office. The outcome of the events tired was recovered on 18Apr2021, really high fever was recovered on 17Apr2021, back ache was recovered on an unspecified date in 2021 whereas she was sick with covid was unknown.  Follow-up 15Jun2021: New information from a contactable consumer includes patient medical history, vaccine administered information, events onset date, Physician room visit, outcome of events, adverse event details.
On 4/8/21 Physician was administering Covid-19 vaccines at our clinic in the lawn and garden center.  She had a patient who was there to receive her first dose of the vaccine.  After the vaccine was administered, she was okay and went to sit in the waiting area.  Shortly later she came back up to the pharmacist table and reported feeling dizzy, lightheaded and nauseous.  Physician then told the patient to sit right by her so she could keep a better eye on her.  The patient said she was okay and then suddenly she passed out.  Physician was able to catch her as she was falling out of the chair and was able to lay her down on the floor.  She may have bumped her head slightly on the ground during this process.  Physician then reports that the patient's breathing sounded labored, and the patient was not conscious.  At that point Emergency department was called.  Physician removed the patients mask and was preparing to administer an EpiPen due to the labored breathing but then the patient regained consciousness.  The Emergency operator advised her to keep the patient on the ground until EMS arrived on scene.  Patient was conscious and okay on the ground.  EMS then came and took care of the patient.  It was deemed that the patient gets lightheaded when she gets bloodwork done usually and believes this may have been an anxiety event. She did not want to go to the hospital.  She felt a bit dizzy once she was sitting back upright and EMS approved the patient drinking some water.  This seemed to help, and the patients color came back.  The patient sat with Physician for a while and then felt back to normal and left on her own accord.
Severe Vertigo,  with intermittent Nausea, Vomiting, Dizziness for9 hours. Called 911 and taken to ER
Presented to ED 2 days after immunization with DTaP with fever 103.7 rectal, no source of infection on exam.  Normal TMs, normal OP, normal lungs on auscultation.  Normal UA - urine cx pending.
This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (initially stored in the refrigerator on 27Jul2022 and administration of vaccine on 31Aug2022.) and NO ADVERSE EVENT (No adverse event) in a child patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1412B) for COVID-19 prophylaxis. No Medical History information was reported. On 31-Aug-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (initially stored in the refrigerator on 27Jul2022 and administration of vaccine on 31Aug2022.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (initially stored in the refrigerator on 27Jul2022 and administration of vaccine on 31Aug2022.) and NO ADVERSE EVENT (No adverse event) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (initially stored in the refrigerator on 27Jul2022 and administration of vaccine on 31Aug2022). 3 kids who got the Moderna 6 month to 5-year-old lot number AS1412B yesterday 31Aug2022 and it looks like it expired on the 27th. The reporter like to know if we have information regarding re-administration for those doses and what to do? The vial was initially stored in the refrigerator on 27Jul2022. The date of administration of vaccine on 31Aug2022. The vial did not undergo any temperature excursions. All three patients were under 5 years old. Reporter declines providing any additional patient information.
Flu-like symptoms; Nasal drip caused her to cough a lot; Felt so poorly; Headache; Nasal drip, including a runny nose and post-nasal drip; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16th October 2019, the patient received the 1st dose of Shingrix (intramuscular). In October 2019, less than a week after receiving Shingrix, the patient experienced cough and feeling unwell. On 17th October 2019, the patient experienced influenza-like symptoms, headache and runny nose. On 19th October 2019, the outcome of the influenza-like symptoms was recovered/resolved. On 21st November 2019, the outcome of the feeling unwell was recovering/resolving. On an unknown date, the outcome of the headache, runny nose and cough were recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms, headache, runny nose, cough and feeling unwell to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix intramuscularly. On 17th October 2019, 1 day after vaccination with Shingrix, the patient experienced flu-like symptoms,  headache and nasal drip, including a runny nose and post-nasal drip, that lasted for 5-6 weeks.  The nasal drip caused her to cough a lot as well.  On 21st November 2019, the patient started feeling better. She saw her doctor for the headache and nasal drip and had an MRI done, but nothing showed on the scan.  She never got sick and was concerned about how she felt so poorly for so long. The reporter consented to follow-up.      Lab Comments: On an unknown date, in 2019, the patient had an MRI done.
Began having seizures on 2/6/2021 a day after having vaccination. Husband of patient reports patient having 2 seizures on 2/6/2021. Pt transported to ER for testing. Husband denies pt receiving any treatments. Pt underwent various tests. Pt sent home. Husband reported pt having altered mental status from seizures. Pt then had 4 more seizures on 2/7/2021. Husband states pt had altered mental status but her condition began improving after seizures. Pt has not returned to baseline cognitive function as stated by husband. Husband states pt has a history of seizures and is prone to having seizures. Pt also in early stages of dementia.
First 4 days after vaccine administration: large red welt (3.5 inches across) and swelling around injection site on upper left arm Days 5 thru 7: no symptoms Day 8: large red welt returned with swelling and itching
Breakthrough case admission after third dose Moderna 3/4/21 Lot# 029A21A Moderna 4/1/21 Lot# 016B21A Moderna 11/15/21 Lot # 013F21A
REALLY UNCOMFORTABLE BODY ACHES; SLIGHT FEVER; This spontaneous report received from a patient via a company representative concerned a patient of an unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure no follow up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced really uncomfortable body aches, and slight fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from really uncomfortable body aches, and slight fever. This report was non-serious.
tested positive for hyperthyroidism with suppressed TSH levels on 5/20/2022; diagnosed on 5/25/2022 with thyroiditis triggered by Moderna COVID booster
Patient has pain, tingling, numbness from the injection site down her arm. She has to raise her arm about her head to relieve the symptoms. She also has a hard spot (1/4-1/2 inch in size) at the injection site. She said at times her entire arm feels hard as if is is swollen. The pain comes and goes, but the tingling and numbness it present the majority of the time.
Patient called 57 minutes after receiving ZOSTAVAX subcutaneously complaining of numbness in left arm opposite of the arm he got the shot. Pt was heading to ER.
I caught covid around May 22, 2022. I had respiratory symptoms, and they lingered for about 3 weeks. I am still having respiratory symptoms, even today, where its difficult to breathe. I have needed to use a nebulizer. I have been weak and exhausted. I have been regularly short of breath and been having very bad brain fog. I have regularly been having to take naps and not feeling good. Sometimes I have better days than others, and sometimes they are not so good. I went to an urgent care and was prescribed Cromolyn and Budesonide. I am still having really bad brain fog.
Information has been received from a health professional concerning a 14 year old female with a sulfonamide allergy and no medical history who on 07-SEP-1995 was vaccinated with a 0.5ml dose of Varivax (Oka/Merck) (diluent lot # 513486/1527A). There was no concomitant medication. On 25-FEB-2006 the patient experienced a severe case of chicken pox with greater than 200 lesions. The patient was recovered as of 21-MAr-2006. Unspecified medical attention was sought. No product quality complaint was involved. Follow-up information from a health professional indicated that on 25-FEB-2006 the patient developed a full blown case of chickenpox, with hundreds of lesions. The reporter considered the patient's reaction to be an other important medical event. The patient's brother (WAES 0603USA03382) had a similar reaction after vaccination with Varivax. Additional information is not expected.
Patient received his 2nd COVID-19 vaccine on 3/24/21 therefore was fully vaccinated.  Patient was seen at clinic 8/25/21 for symptoms of COVID-19 and tested positive for COVID.
started to get little red marks had all red blotches in chest and arm; terrible headache; it was as red as an apple; itched in chest and arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RASH MACULAR (started to get little red marks had all red blutches in chest and arm), PRURITUS (itched in chest and arm), HEADACHE (terrible headache) and ERYTHEMA (it was as red as an apple) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE and Amadelz for an unknown indication.    On 15-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 30-Jan-2021, the patient experienced PRURITUS (itched in chest and arm). On an unknown date, the patient experienced RASH MACULAR (started to get little red marks had all red blutches in chest and arm), HEADACHE (terrible headache) and ERYTHEMA (it was as red as an apple). At the time of the report, RASH MACULAR (started to get little red marks had all red blutches in chest and arm), PRURITUS (itched in chest and arm) and ERYTHEMA (it was as red as an apple) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Took Benadryl and Triamcinolone acetonide cream. Hydroxycine prescription so that they could sleep better (took it one night). Dermathologist was going to prescribe Prednisone for skin rash but did not try it in the end. Family doctor told them to take Claritin and Zyrteck if it continues. One doctor told them to go to the ER and got an IV steroids if it came back.
Patient received Moderna COVID19 vaccine for the booster injection by clerical error, after receiving Pfizer COVID19 vaccine for initial vaccination injection.  Patient was observed for 15 minutes with no adverse effects noted. Patient denies any adverse reactions when questioned upon release from observation. Patient was advised of error and given best practice information about her vaccine and possible outcome. Patient voiced understanding.
Cannot lift the left arm; Pain in the entire left  arm; pain in the left arm has become worst; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in the entire left  arm), PAIN IN EXTREMITY (pain in the left arm has become worst) and LIMB DISCOMFORT (Cannot lift the left arm) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Apr-2021, the patient experienced PAIN IN EXTREMITY (Pain in the entire left  arm) and PAIN IN EXTREMITY (pain in the left arm has become worst). On 03-May-2021, the patient experienced LIMB DISCOMFORT (Cannot lift the left arm). At the time of the report, PAIN IN EXTREMITY (pain in the left arm has become worst) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to US-MODERNATX, INC.-MOD-2021-106708 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-106708:
Tested negative after Paxlovid treatment on 29Jun22 then tested positive again on 03Jul22; Tested negative after Paxlovid treatment on 29Jun22 then tested positive again on 03Jul22; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old female patient received BNT162b2 (BNT162B2), on 06Mar2021 as dose 1, single (Lot number: EN6205), on 27May2021 as dose 2, single (Lot number: ER8730) and on 05Oct2021 as dose 3 (booster), single (Lot number: FD8448) at the age of 47 years for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset 03Jul2022, outcome "not recovered", DRUG INEFFECTIVE (medically significant) with onset 03Jul2022, outcome "not recovered" and all described as "Tested negative after Paxlovid treatment on 29Jun22 then tested positive again on 03Jul22". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (29Jun2022) Negative; (03Jul2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: The patient tested negative after Paxlovid treatment on 29Jun2022 then tested positive again on 03Jul2022 after starting to feel unwell. Patient received Paxlovid from 22Jun2022 to 26Jun2022, as treatment of COVID-19. Other medication in 2 weeks: Unknown.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200930857 same patient/vaccine, different dose/events;
01/16/22 presents to ED for "coughing up blood" "nauseated". PMHx of "HTN, CAD,ESRD on HD, Afib on Warfarin, VT with ICD"
Strong headache, body pain, tiredness. On the 3rd day  a bump appear next to my shoulder, the same side as the vaccine.
Approximately 3 minutes following administration of vaccine, the skin on the patients face, arms, and legs turned red and the patient began to sweat profusely. The patient reported that he was feeling dizzy and had blurred vision. The patient did not report any shortness of breath or swelling of the face, throat, or lips. Physical assessment confirmed patients report of no swelling of the face, throat, or lips. The patient was treated with an ice pack to the back of the neck and was advised to place his head between his legs. The pharmacy student remained with the patient for 30 minutes after the reaction occurred. During the 30 minutes, the patient reported that his dizziness and blurred vision were improving and he was no longer sweating. Physical assessment of the injection site found that there was no redness, swelling, or rash developing. After 30 minutes had elapsed since the reaction, the patient reported that he was no longer dizzy, experiencing blurred vision, or sweating. Assessment of the injection site at this point was the same as above with no redness, swelling, or rash occurring. At this point, the patient was cleared to leave the pharmacy and was advised to go home and rest for the night and not perform any strenuous activity.
FATIGUE; ARM SORENESS AT THE INJECTION SITE; This spontaneous report received from a patient concerned a 73 year old female. The patient's weight, height, and medical history were not reported. The patient previously received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin not reported and batch number: 1805018, expiry: 20-JAN-2022) dose was not reported, 1 total administered to left arm on 16-MAR-2021 for prophylactic vaccination. The patient had fatigue and arm soreness at the injection site following vaccination with first dose of covid-19 vaccine ad26. cov2. s (Dose number in series 1). The patient recovered from fatigue, and arm soreness at the injection site. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number: 1822811 expiry: 17-AUG-2022) dose was not reported, 1 total administered to left arm on 05-NOV-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, following vaccination with covid-19 vaccine ad26.cov2.s, (dose number in series 2) the patient experienced fatigue and arm soreness at the injection site (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fatigue, and arm soreness at the injection site. This report was non-serious. This case, involving the same patient is linked to 20220702519.
This case was reported by a consumer via out of hour services and described the occurrence of injection site erythema in a female patient who received SHINGRIX for prophylaxis. On 19th October 2018, the patient received SHINGRIX. On 20th October 2018, 1 days after receiving SHINGRIX, the patient experienced injection site erythema. On 21st October 2018, the patient experienced injection site pain and injection site swelling. On an unknown date, the outcome of the injection site erythema, injection site pain and injection site swelling were unknown. It was unknown if the reporter considered the injection site erythema, injection site pain and injection site swelling to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient noticed a bright red spot at the injection site about the size of a quarter. On 21th October 2018, 2 days after receiving SHINGRIX the patient's red spot was 2.5 to 3 inches in diameter, bright red, was tender and slightly swollen. The red spot was not painful unless the patient touches it.
Began rabies vaccination series 08/12/2002, followed by injections 08/15,08/19 and 08/26. States that he got a headache and had abd pain x 2 days after each shot.
Moderate soreness in left arm. I am a physician and I have heard from many friends who are elderly that they had some significant arm pain for 3-4 days after the injection. I wonder if it is because we have had 2 injections in the same place 3 weeks apart. All of them say that the first shot did not hurt. Maybe the 2 shots should be given in different locations to alleviate the pain problem. Just a suggestion. It may be beneficial to study this as well as it would decrease adverse reports.
pt very sleepy x 6 hr; also had high pitched cry x 20 mins;
Fever 101 degrees local soreness, headache, overall myalgias (No f/u /Temp Sxs). Still had tenderness @ site n 3/20/06.
Dizziness, Headache, Fever, Diarrhea, HIVES Narrative:  HEADACHE CONTINUES
lt upper arm 6x10cm area of erythema, warmth, tenderness treatment ice, APAP;
Per mother, 1 day after vaccination; reddened, swelling at site to induration of 80x45mm (noted 30 days after injection); small red, raised "pimpley" rash over site.  Mother showed MD.  Brought to RN attention when pt brough in for 2nd flu shot.  Mother claims no temperature, cough or apparent discomfort at site, but redness apparent 30 days later, site measured.  No Benadryl per mother at time of initial reaction.  #1 dose preserv add multidose vial.