chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received 4th dose; This spontaneous case was reported by a consumer and describes the occurrence of EXTRA DOSE ADMINISTERED (Patient received 4th dose) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 083J21A, 031A21A, 001C21A and 011D21A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised and Renal disease (Diagnosed with Kidney disease years before patient got his1st dose of moderna COVID-19 vaccine.).   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Feb-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 18-Feb-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXTRA DOSE ADMINISTERED (Patient received 4th dose). At the time of the report, EXTRA DOSE ADMINISTERED (Patient received 4th dose) outcome was unknown.            Patient was in the list for Kidney transplant candidates On 14-Feb-2022, patient was advised by his doctor to get a 4th dose.Patient was told by the pharmacist that he got half dose Concomitant product information was not provided Treatment information was not provided
8/26 Shingles breakout (pox, itching, redness) Severe pain at injection site for 1 1/2 weeks severe pain during blood draw at same Dr office on 8/27 9/14 woke up with aggravated breakout on my right arm, blisters, rash, itching , burning, inflamed
This spontaneous case reported by a consumer, describes the occurrence of thyroiditis (inflamed thyroid) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 031M20A and 001B21A) for COVID-19 immunization. No medical history reported. On Feb 13, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Mar 14, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced thyroiditis (inflamed thyroid). At the time of the report, thyroiditis (inflamed thyroid) outcome: unknown/not provided. No concomitant medication reported. The treatment information: unknown. Action taken with mRNA-1273 in response to the event: not applicable. Most recent follow-up information incorporated: On May 25, 2021: Non-significant follow-up.
pt recv vax 8FEB97 & 21FEB97 pt devel red dots all over body;
4 month-old child was supposed to receive Pentacel vaccine, but received Quadracel instead, no AE; 4 month-old child was received Quadracel, no AE; Initial information received on 05-Mar-2021 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a four month old female patient who received DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] instead of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (wrong product administered and product administered to patient of inappropriate age).  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.  On an unknown date, the patient received a dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE (lot number and expiry date: not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  It was a case of actual medication error due to wrong vaccine administered and inappropriate age at vaccine administration.  It was also reported that 4 month-old child was supposed to receive Pentacel vaccine, but received Quadracel instead.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Had a cough for a few days prior to 4/1.  Evening of 4/1 I got body aches and fever. 4/2 woke up with body aches and fever.  Felt like having flu and a cold together.  Tested positive on At Home COVID-19 test.  4/4 contacted doctor through Televisit.  Proscribed antiviral and advised to treat symptomatically.  4/6 I noticed symptoms improving, just felt ?less awful.?  By 4/8 symptoms were mostly gone with extreme fatigue lingering for a month.
Extreme joint pain tiredness fingers felt cold and ached to touch anything sore neck in lymphnode area then the headaches started a few days later like 5 days i felt very tired weak not sick to stomach but felt like blood was dirty hard to explain right kidney hurt then weeks of headaches felt like head was bleeding it hurt so bad chest felt like  just got over  a chest cold or bronchitis  or ran out in cold weather and also very cramped feet some of this still happening but most has subsided . The scariest part was the feeling of my headache terrible .i never went to a er or doctor but almost did.
CHILLS, HEADACHE, BODY ACHE AND FELT KINDA WARM , I HAD TO LAY DOWN AND TAKE 1 ADVIL WHICH ALL STARTED A WEEK LATER  ABOUT 1PM SUNDAY  AND WENT ON TILL ABOUT 6PM THE SAME DAYAND MOVED ON.
Extreme swelling, hot to touch, very painful for infant. (For at least 2 weeks after) Seemingly itchy. It has been nearly 2 months since the vaccine was given, the redness and swelling has subsided but there is still a hard lump under the skin where she got her vaccine.
pt recv vax 9APR96 & 24APR96 pt exp unexplained fever which ranged from 102 to 104.5;blood cult were drawn which indicated no bacteremia, 16,200 neutrophils, & 10% monocytes;tx w/med;
stiffness in injection arm; throbbing in injection arm; injection arm is sore; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (stiffness in injection arm), PAIN (throbbing in injection arm) and VACCINATION SITE PAIN (injection arm is sore) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (stiffness in injection arm), PAIN (throbbing in injection arm) and VACCINATION SITE PAIN (injection arm is sore). At the time of the report, MUSCULOSKELETAL STIFFNESS (stiffness in injection arm), PAIN (throbbing in injection arm) and VACCINATION SITE PAIN (injection arm is sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       concomitant medicines was not reported by reporter  treatment information was not provided   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.; Sender's Comments: Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. Vaccination site pain is consistent with the product known safety
Right arm metacarpal (wrist) joint inflamed. Round hard (grape size) inflamed joint.
Shot 1 (early March 2021): No side effects except for a sore arm  Shot 2 (late march 2021): tension headache and brain fog on-and-off for 2 months. When experiencing brain fog, there was usually some visual field disorientation. Not quite tunnel vision, but felt like things in my periphery were harder to process, and in general I felt mentally a beat behind.  Shot 3 (Mid december): Initially, only sore lymph nodes. However, a month after the shot, out of seemingly nowhere the tension headache and brain fog returned, with vision issues. This has lasted about a week now, and has been more consistent than before, but a bit more mild? however still frustrating and debilitating. I am having trouble focusing and this is also preventing me from Cycling (my passion), as I feel it's risky when feeling mentally disoriented.  I have never experienced any of these symptoms in my life except after vaccination.
6 days post vaccination, I woke up a bit tired and went to work. Around 10:00AM I started to get a headache and sore throat. By 05:15PM I started to feel worse and I took a COVID-19 at home test, and it did come out positive. I then called my doctor the next morning and I was prescribed Paxlovid, a modified version due to elevated kidney levels. As of today I am starting to feel slightly better however still not 100%. I think that the version of COVID-19 that I have is definitely on the milder side.
This case was reported by a consumer via call center representative and described the occurrence of cough in a elderly male patient who received dTpa vaccine for prophylaxis. On an unknown date, the patient received dTpa vaccine. On an unknown date, 14 days after receiving dTpa vaccine, the patient experienced cough. On an unknown date, the outcome of the cough was not recovered/not resolved. It was unknown if the reporter considered the cough to be related to dTpa vaccine. Additional details were provided as follows: The age at vaccination was not reported. The reporter was the patient's wife and the patient got vaccinated with Tdap booster two days before his wife did about 8 weeks (2 months before the reporting date) in expectation of 2 new grandsons. The patient took cholesterol and triglyceride reducers as concomitant drugs. The patient started coughing about 2 weeks later. One baby came early, was in Neonatal intensive care unit (NICU) and there was no way they would let him in with that cough. The vaccine was supposed to be killed virus, not live. This case has been linked with case US2018176406 (wife's case) reported by the same reporter.
Pt reports she received vaccine on 4/21/2000. Post vaccine she developed rash on her arm. The rash then became generalized; itched and burned. The rash persisted as of 7/6/2000.
Dose administered after 30-day Use By Date or after manufacturer date of expiry; The vaccine was thawed before the administration throughout the end of March to the beginning of April.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry) and PRODUCT STORAGE ERROR (The vaccine was thawed before the administration throughout the end of March to the beginning of April.) in an adult female patient who received mRNA-1273 (Spikevax) (batch no. 059H21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry) and PRODUCT STORAGE ERROR (The vaccine was thawed before the administration throughout the end of March to the beginning of April.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry) and PRODUCT STORAGE ERROR (The vaccine was thawed before the administration throughout the end of March to the beginning of April.) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug information was provided. Dates of administration of vaccine: 19 patients were administered on 29Mar2022, 30Mar2022, 31Mar2022, 01Apr2022 and 04Apr2022. The vaccine didn't undergo any temperature excursion issue. Product was placed in refrigerator on 1-Apr-2022.
Red, swollen sore arm, low grade fever, couldn?t lift arm.  After 2 days fever subsided , swelling went down and arm started to itch. Back to normal on day 3.
1st Day - no symptoms, 2nd day runny nose, sore arm, and chills, 3rd day runny nose, chills, diarrhea, 4th day fatigue, runny nose, diarrhea, 5th day headache, fatigue, and nausea.
vaccine administered after excursion ocurred; This spontaneous report was received from a physician  and refers to a patient of unknown age and gender. Information regarding the patient's  concomitant therapies, concurrent conditions, medical history and historical drugs was not provided.  On 21-AUG-2020, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (VARIVAX) lot # S038698, expiration date 01-DEC-2021 for prophylaxis  (strength, dose, frequency, and route of administration were not reported).    The improperly stored suspect vaccine experienced a temperature of -10.2 degree Celsius (°C) for 1 hour and 53 minutes with no previous temperature excursion.  The call was made due to a digital data logger.  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2008USA014798: US-009507513-2008USA014806: US-009507513-2008USA014825: US-009507513-2008USA015018: US-009507513-2008USA015035: US-009507513-2009USA000117:
received the first dose / on 06Nov2019 / has not received the second dose yet; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 75-year-old male patient who received HAV (Havrix) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Havrix (received 1st dose on 6th November 2019, no adverse reaction was reported).   On an unknown date, the patient received the 2nd dose of Havrix and Havrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, patient did not received 2nd dose of Havrix, which led to incomplete course of vaccination. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up.
Information has been received from a patient's mother referring to her 5 year old daughter without pertinent medical history. On 23-APR-2015 the patient was vaccinated with a dose of M-M-R II (lot# reported as L003221, injection, route and strength and expiration date were unknown). There was no concomitant medication. On 25-APR-2015 the patient developed a 102.8 fever at 17:00 that lasted until 09:00 the next morning. And during this time of the fever, the patient broke out into "full blown measles all over her body." The mother took the patient back to the physician's office (date unspecified) and the patient was seen by two physicians one was the physician who administered the vaccine and other was the senior physician of the practice, both stated that this was a "severe, very severe case of measles" and the senior partner stated "the worse case I have seen in years." The patient was treated with calamine lotion, TYLENOL, NEOSPORIN AF and BENADRYL. At the time of this report, the outcome of the event was not resolved. Additional information has been requested.
heart rate of 140, chest pain sharp right side of chest.  started two hours after vaccine.
This spontaneous report as received from a licensed practical nurse refers to a unspecified number of patients of unknown age and gender. Concurrent or medical conditions were not reported. On an unknown date, the patients were vaccinated with ZOSTAVAX (dose, strength, frequency, route and lot number were not reported). Secondary suspect and concomitant therapies were not reported. The nurse reported that 70-80% of all patient that were administered with ZOSTAVAX developed injection site reactions. The outcome of injection site reaction was not reported. This is one of two reports received from the same source. Additional information has been requested.
After two days post injection, injection site became extremely red and swollen, this lasted until the 8th of February. On Sunday the 9th a bumpy rash appeared and has lasted up until today the 12th. Surrounding the affected area there is possible vasoconstriction because of there being a whitening to the skin around the rash.
Fever 101.2; Severe headache; Severe body aches; Primary immunisation: MODERNA; Booster: BNT162b2; This is a spontaneous report from a contactable reporter (nurse). The reporter is the patient.  A 37-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 21Jan2022 at 10:00 (Lot number: unknown) at the age of 37 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Supraventricular tachycardia" (unspecified if ongoing), notes: SVT; "Heart murmur" (unspecified if ongoing); "Hashimoto's thyroiditis" (unspecified if ongoing); "Asthma" (unspecified if ongoing) and "Multiple allergies" (unspecified if ongoing), notes: Allergies. Concomitant medications included: LEVOTHYROXINE and BENADRYL. Past drug history included: Flonase, reaction: "Drug allergy", notes: Known allergies: Flonase; Fentanyl, reaction: "Drug allergy", notes: Known allergies: Fentanyl; Singulair, reaction: "Drug allergy", notes: Known allergies: Singulair; Albuterol, reaction: "Drug allergy", notes: Known allergies: Albuterol and Mmr, reaction: "Allergy to vaccine", notes: Known allergies: MMR vaccine. Vaccination history included: Moderna covid-19 vaccine (DOSE 2, SINGLE; Lot Number: Unknown; Anatomical site: Left arm; Route of administration: Unspecified), administration date: 20Jan2021, when the patient was 36 years old, for COVID-19 immunisation and Moderna covid-19 vaccine (DOSE 1, SINGLE; Lot Number: Unknown; Anatomical site: Left arm; Route of administration: Unspecified), administration date: 23Dec2020, when the patient was 36 years old, for COVID-19 immunisation. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 21Jan2022 at 10:00, outcome "unknown", described as "Primary immunisation: MODERNA; Booster: BNT162b2"; PYREXIA (non-serious) with onset 22Jan2022 at 12:00, outcome "recovering", described as "Fever 101.2"; HEADACHE (non-serious) with onset 22Jan2022 at 12:00, outcome "recovering", described as "Severe headache"; PAIN (non-serious) with onset 22Jan2022 at 12:00, outcome "recovering", described as "Severe body aches". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, headache and pain.  Additional Information: The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Lethargic, racing heart, nauseous, general unwell feeling, feeling "detached" from self.
Pt tested positive for COVID on 7/7/21, s/p being fully vaccinated with Moderna
Covid positive; Covid positive; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 55-year-old female patient received BNT162b2 (BNT162B2), on 06Jan2021 at 11:00 as dose 1, single (Lot number: ER9231), in left deltoid, on 27Jan2021 at 11:00 as dose 2, single (Lot number: EL9261), in right deltoid and on 26Dec2021 at 10:00 as dose 3 (booster), single (Lot number: 330258D) at the age of 55 years, in left deltoid, all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Grief", start date: 2020 (ongoing); "Allergies" (unspecified if ongoing); "Joint health" (unspecified if ongoing); "Bone health" (unspecified if ongoing); "Knee surgery" (ongoing); "Depression", start date: 2020 (ongoing). Concomitant medication(s) included: VENLAFAXINE oral taken for depression, start date: 2020 (ongoing); CETRIZINE oral taken for multiple allergies, start date: 2007 (ongoing); OSTEO BI-FLEX [CHONDROITIN SULFATE;GLUCOSAMINE HYDROCHLORIDE] oral taken for arthropathy, start date: 2015 (ongoing); CALCITRATE oral taken for bone disorder, start date: 2018 (ongoing).  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 17Aug2022, outcome "recovered" (22Aug2022) and all described as "Covid positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (14Aug2022) Positive; (17Aug2022) Positive.  Clinical course: Complete if a 3rd or Subsequent dose was administered. Check one option: Booster dose due to high risk of frequent institutional or occupational exposure to coronavirus (and at risk of serious COVID-19 complications): Checked, Healthcare. worker. Drug Name: Multivitamin, route: oral. Farmly Covid positive on 14Aug2022. Patient tested positive on 17Aug, only symptoms are sinus drip daily plus low-grade fever 100.5 on day 0. fever free next 5 days. Family Medical History Relevant to Adverse Events (AEs): Her husband contracted COVID early in the pandemic and dead due to the illness in May2020. She had initial exposure, but never had symptoms, therefore never tested but did have a neg antibody test months later. Specific Relevant Test for thromboembolic events with thrombocytopenia was none reported.; Sender's Comments: Based on the information currently available, The casual association between the reported eventS and suspected drug cannot be completely excluded.
On about 3/12/2021, I noticed that I hadn't had a bowel movement in a while. I started taking two Linzess tablets instead of the usual one I had been taking at the time. Doing that and even drinking a 16-ounce bottle of prune juice didn't get my bowels moving! Some days I would also take enemas, and they also didn't help. I then bought Dulcolax and then began taking them in the evenings in the hope that they would enable me to go to the bathroom the following morning, but they also didn't help. I then got in touch with a proctologist and he suggested that I take mineral oil. That didn't help. I also tried castor oil, which was to no avail. Dr. then told me that if I didn't have a bowel movement soon, I would have to go to urgent care. He suggested that if I wanted to avoid that, I should try donning surgical gloves with Vaseline and inserting my fingers into my rectum to move the stool. I was then finally able to start defecating again afterwards; the stool was soft, but I had had trouble releasing it. Ever since, I have been taking the laxative Nopalina on a regular basis, which is every other night, and it now keeps me regular.
Pt states approximately 8 hours after vaccine noted sudden onset shortness of breath at rest. Sx lasted 2 hours and resolved. Also - bright red, blood shot sclera that persists after 16 hours.