chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Irregular heart beat, flutters, etc started about a week after first Pfizer shot.   I have felt flutters before - perhaps once a year - maybe once or twice.  This lasted for about a week to 10 days and was several times per day.  I thought it was odd, and wondered if it had anything to do with the vaccine.  I did some minor research at the time and didn't really see anything.    It went away on its own after about 10 days and has NOT returned.   I received my second Pfizer shot on 5/13/21 and that did not trigger any additional heart issues.  Seem odd as most people have this issue after their second shot.   I did not report this until now  - but I should have as if everyone reports any and all issues, researchers can then clearly get a good snapshot as to what exactly is going on and in what types of patients.  Thank you.   I did not see a doctor for this.
Had a localized reaction, redness, swelling, fever.  Patient taken to ER.  Followed up with PCP 2/28/08.
100.4 degree fever temporal after 1000mg of Tylenol 2-3 hours ago. Uncontrollable shivers at times. Body feels sore and have a headache.  But the most concerning symptoms is minor purple discoloration of my fingernails and toenails.  No shortness of breath though
UTI; This spontaneous case was reported by a consumer and describes the occurrence of URINARY TRACT INFECTION (UTI) 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 URINARY TRACT INFECTION (UTI). At the time of the report, URINARY TRACT INFECTION (UTI) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications reported.  No treatment information was provided.
nausea/urge to vomit; Dizziness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558) (from a Pfizer sponsored program Covax US Support).  A male patient received bnt162b2 (BNT162B2), administration date 21Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NAUSEA (non-serious) with onset 2021, outcome "unknown", described as "nausea/urge to vomit"; DIZZINESS (non-serious) with onset 2021, outcome "unknown", described as "Dizziness".  Additional information: The reporter was calling on behalf of his father and would like to know if those are the side effects of the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
got the shingrix vaccine both shots / Two weeks later started breaking out with shingles / Got shingles after getting the vaccine; Small bumps itching like crazy; Small bumps / small bumps got some on my arms and a few on my legs.; This case was reported by a consumer via call center representative and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 2 weeks after receiving Shingrix, the patient experienced shingles, itchy rash and papular rash. On an unknown date, the outcome of the shingles, itchy rash and papular rash were unknown.   It was unknown if the reporter considered the shingles, itchy rash and papular rash to be related to Shingrix.  Additional details were provided as follows: This case was reported by patient herself/himself The age at vaccination was not reported. The patient stated that he/she did not had an outbreak before the shot. The patient had received both the shots of Shingrix and two weeks later started breaking out with shingles. The patient had small bumps itching like crazy and got some small bumps on his/her arms and a few on his/her legs. The reporter asked why he/she was breaking out with shingles after receiving the shots. The follow-up would not possible as no contact details were available
INCORRECT PRODUCT STORAGE; ADMINISTERED PATIENTS USING AN EXPIRED AND  IMPROPERLY STORED VIAL OF THE J&J  COVID-19 VACCINE; This spontaneous report received from a physician concerned a 40 year old male. 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: 211D21A, expiry: 08-SEP-2022) .5 ml, administered on 25-MAR-2022 for prophylactic vaccination. Age at time of vaccination 40 years old. No concomitant medications were reported. On 25-MAR-2022, the patient experienced administered patients using an expired and improperly stored vial of the j&j covid-19 vaccine. On an unspecified date, the patient experienced incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administered patients using an expired and improperly stored vial of the j&j covid-19 vaccine and incorrect product storage was not reported. This report was non-serious. This report was associated with product quality complaint: 90000233203. This case, from the same reporter is linked to 20220558497, 20220558479, 20220558475, 20220558469, 20220558498 and 20220558436.
Initial report received 29 April 2008 from a health care professional. A cluster of four unidentified patients developed a black dot at the injection site after receiving an injection of IPOL, lot number A0298-2 (route/site not reported). At the time of the report, the patients had not recovered from the event. The reporter received a cluster of reports of black dots at the injection site from multiple satellite locations who were all affiliated with the reporter. The facilities used alcohol wipes and syringes which included safety glide and vanish point with 25 gauge needles. Some of the black dots were reported to have appeared immediately with some present two months post immunization. This event had been noticed by all health care workers at the facilities and had not been noticed in the past. The reporter indicated follow-up information would be provided as it is obtained. Additional information was received from the initial reporter on 02 May 2008. The reporter provided individual patient identifiers for the four previously unidentified patients. The information contained in this case (2008-01338) is now for a two-month-old female, whose black dot appeared on 24 March 2008. This patient's case was one of four cases which were reported from the same satellite site. The information for the other three patients is contained in cases 2008-01427, 2008-01428, and 2008-01429. The reporter for this case is the same as for case numbers 2008-01333 (IPOL and ActHIB), 2008-01334 (IPOL), 2008-01335 (IPOL), 2008-01336 (IPOL and DTaP), 2008-01339 (Fluzone), 2008-01427 (IPOL), 2008-01428 (IPOL), and 2008-01429 (IPOL). These events occurred at multiple satellite locations which are all affiliated with the reporter.
Immediate redness, itchiness on vaccination site. As time progresses, redness on site is rising, hard, hot, and increasing in size. Now, at 19 hours post vaccination, arm is aching from wrist to shoulder. As to question 9 - arm has not recovered yet.
patient started to feel warm, ringing in ear, blurred visions, signs of syncope with no true fainting, Patient monitored given ice pack, fan and water until cooled down. pt did not need to go to emergency room or call 911
Pt. started with urticarial rash approx. 24 hours after administration of 6 mos. immunizations. Treated with BENADRYL, then po steroids (also fever to 101 degrees).
Information was received on  01-JUN-2017 from  a registered nurse who was reporting a on a  female patient of unknown age. No medical history or concomitant medications were reported. On 14-AUG-2012, the patient received a dose of GARDASIL (no lot, expiration, dose, route or site reported) for prophylaxis. On 25-APR-2017 the patient received a dose of GARDASIL 9 (lot M043731, expires 22-JUN-2019, no dose or site reported) for prophylaxis. On 01-JUN-2017 the patient received the second dose of GARDASIL 9 (lot M043731, expires 22-JUN-2019, no dose or site reported) also for prophylaxis. No adverse effects were reported. No additional information is available. Additional information is not expected. No further details available.
was diagnosed with shingles; severe fatigue; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (was diagnosed with shingles) and FATIGUE (severe fatigue) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044B21A and 021B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 26-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Apr-2021, the patient experienced HERPES ZOSTER (was diagnosed with shingles) and FATIGUE (severe fatigue). At the time of the report, HERPES ZOSTER (was diagnosed with shingles) and FATIGUE (severe fatigue) outcome was unknown.            No concomitant medications were provided. Treatment with Antibiotics(not specified) for the pertained events, was provided by the patient.   This case was linked to MOD-2021-092011 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-May-2021: Reporters contact information was added
Shaking chills, severe for about an hour. Non productive to semi cough severe for about 16 hours. Then moderate cough for 3 days. No taste for weeks. I took Paxlovid.
On May 7, developed eye pain and redness. Sought treatment on May 8, 2021 at urgent care center. Was prescribed eye drops with antibiotic and steroids. Took eye drops 4 times daily for 5 days. Symptoms returned two days after stopping eye drops. Experienced redness of eye, throbbing/stabbing pain and sensitivity to light in right eye. Sought care from ophthalmologist  on 5/19/21 and diagnosed with acute anterior uveitis.
7/23/2022 I had mild cold symptoms with a sore throat. It started getting worse with a fever. I had to take Tylenol.  I tested positive for COVID-19. I was given Paxlovid and completed the full 5 day prescription. I started feeling better by the 6th day. I started having cold symptoms again and tested positive for COVID-19. At this moment I feel a lot better and no longer tested positive.
inappropriate schedule of vaccine administered; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccine administered) in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Allergic to Bactrim), Coronary artery disease (CAD), Low back pain, AFib, Hypertension (HTN) and Hyperlipidaemia (HLD). Concomitant products included ATORVASTATIN, APIXABAN (ELIQUIS), TAMSULOSIN HYDROCHLORIDE (FLOMAX [TAMSULOSIN HYDROCHLORIDE]), FLUOXETINE HYDROCHLORIDE (PROZAC) and POTASSIUM for an unknown indication.   On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccine administered). On 18-May-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccine administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient received booster dose on 13-Dec-2021.  Treatment information was not reported.   This case was linked to MOD-2021-435309 (Patient Link).
No adverse effects; 17-year-old patient received adult dose of VAQTA on 8/14/2019; This spontaneous report was received from a nurse concerning to a 17 year old patient. Information regarding the patient's medical history, concurrent conditions and concomitant medications was not reported.   On 14-AUG-2019, the patient was vaccinated with a adult dose of hepatitis a vaccine, inactivated (VAQTA) (product administered to patient of inappropriate age), lot # S007265 has been verified to be a valid lot number for hepatitis a vaccine, inactivated, expiration date reported  and establish as 07-JUL-2020, for prophylaxis (strength, dose and route of administration were not provided).  No adverse effects reported.
Quarter sized raised lump around injection site. Warm to touch. Hard, red and swollen arm.
17yr old received Moderna vaccine; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17yr old received Moderna vaccine) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17yr old received Moderna vaccine). On 09-Mar-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17yr old received Moderna vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  Treatment information was not provided..   Most recent FOLLOW-UP information incorporated above includes: On 14-Jun-2021: Translated document received on 14-JUN-2021 . No new information reported.; Sender's Comments: This report refers to a case of Product administered to patient of inappropriate age, for mRNA-1273, lot # 030A21A,  with no associated AEs.
Became inconsolable about 4 hrs after shots - screamed for about 4 hours - no temp - mom gave TYLENOL every 4 hours for 24 hours. Still fussy next day.
I received the Janssen vaccine on Wednesday 8-18-2021 and started having tingling sensation on my left lower leg, hands and forearms.
Rash identified by RN as chickenpox 07/07/08 after Varicella vaccine given to child 07/01/08. "Rash" mild <50 lesion reported by mother.
Muscle weakness, numbness and tingling, possible Gullaine Barre or myasthenia gravies
diarrhea; nausea; sneezing; coughing; sore throat; fatigue; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 27-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 18Sep2021 08:30 (Lot number: EW0217) at the age of 27 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "allergies" (unspecified if ongoing); "irregular heartbeat" (unspecified if ongoing); "diabetic" (unspecified if ongoing); "Known allergies: Bee stings" (unspecified if ongoing); "Known allergies: pineapple" (unspecified if ongoing). Concomitant medication(s) included: OZEMPIC; VITAMIN C [ASCORBIC ACID]; VITAMIN D3; VITAMIN E [TOCOPHEROL]; ZINC. Past drug history included: Paxil, reaction(s): "Known allergies: Paxil"; Bupropion, reaction(s): "Known allergies: bupropion". Vaccination history included: Bnt162b2 (product=COVID 19, brand=Pfizer-biontech COVID-19 vaccine eua, lot number=Pfizer EW0217, administration date=28Aug2021, administration time=01:30 PM, dose number=1, vaccine location=Right arm), administration date: 28Aug2021, when the patient was 27 years old, for Covid-19 Immunization. The following information was reported: DIARRHOEA (non-serious) with onset 19Sep2021, outcome "not recovered", described as "diarrhea"; NAUSEA (non-serious) with onset 19Sep2021, outcome "not recovered", described as "nausea"; SNEEZING (non-serious) with onset 19Sep2021, outcome "not recovered", described as "sneezing"; COUGH (non-serious) with onset 19Sep2021, outcome "not recovered", described as "coughing"; OROPHARYNGEAL PAIN (non-serious) with onset 19Sep2021, outcome "not recovered", described as "sore throat"; FATIGUE (non-serious) with onset 19Sep2021, outcome "not recovered", described as "fatigue". Therapeutic measures were not taken as a result of diarrhoea, nausea, sneezing, cough, oropharyngeal pain, fatigue.  Additional information included: Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
A spontaneous report, was received from a Non Health Professional, concerning an unknown age of patient with unknown gender age, who was administered Moderna's COVID-19 vaccine (mRNA-1273) and patients got their injections from a vial that has experienced a temperature excursion (Incorrect product storage). The patient's medical history, concomitant history, lab data was not provided by the reporter. On unknown date,  the patient received their first of two planned doses of mRNA-1273 (Lot number: 028L20A) intramuscularly for prophylaxis of COVID-19 infection. On unknown date, the patient got their injections from a vial that  has experienced a temperature excursion (Incorrect product storage). The Action taken with the second dose of mRNA-1273 in response to the event was not reported. The  outcome of the events were considered as recovered.; Reporter's Comments: This report refers to a case of Product storage error for mRNA-1273, lot #028L20A with no associated AEs.
This spontaneous report was received from a pharmacist referring to a 45 year old male patient. The patient's medical history, concomitant medications and drug history were all unknown. On 17-NOV-2018 the patient was vaccinated with M-M-R II (normal dose, lot# was unknown, expiration date:14-NOV-2018) via subdermal (also reported as subdermic) for prophylaxis (expired product administered). The patient had not complained of any adverse events so far. The outcome of receiving expired vaccine was unknown.
Started with low grade fever at 9:30PM and by 2:00PM the next afternoon fever went up to 103.9.   Controlled fever and severe headache with Mucinex Max.  Ended up sleeping from 9:30PM till around 9:30 PM and then took nightime mucinex and slept till 8:00 am the next morning.   Headache still there most of Friday and by the weekend I was running a 99.5 fever.  Fever finally went away on Monday afternoon.
4/11/2021   Patient was observed post Covid-19 immunization for 15 minutes .  During the observation period, she experienced an adverse reaction with the following symptoms:  Headache.   Assessment : Time of assessment 415pm. Alert and oriented. Complained of headache after injection.   Actions taken:  Vitals sign taken  Reporting form completed  Water and crackers given VS taken at 415 , BP-11/87, P- 76, R- 16, O2- 100%, recheck of VS- at 430pm- BP- 109/75, P- 75, R- 16, O2- 100%       Medications administered: No medication administered.   Disposition: Reports no further symptoms of adverse reaction after observation for 30 minutes. Discharged home. The Patient was provided with Vaccine Information Sheet and instruction to access the mobile reporting system.   She was discharged with husband.     Immunizations Administered    Name Date Dose VIS Date Route   Pfizer COVID-19 Vaccine 4/11/2021  3:53 PM 0.3 mL 12/11/2020 Intramuscular   Manufacturer
Received Tdap on 10/20/07, by 10/21/07 she felt illness starting-achey and nauseous.  Then on 10/22/07 she became very ill with body aches,vomiting, fever and chills, wiith arm with a huge local reaction that encompassed her entire upper arm.  By 10/23 she felt better.  She reports similiar reaction 11 years back when she received Tetanus, and reaction was blamed on illness.
Chills, sweats, malaise, fatigue, headache and myalgia. Acetaminophen/hydrocodone.
Nausea the night of the vaccine. Severe nausea and vomiting the following day. She went to the Urgent care on 4/6/21. The sent her to the ER. The nausea and vomiting lead to hypokalemia, and acute kidney injury.  She was admitted to the hospital from 4/6/21-4/8/21.  Her nausea improved. She was seen by PCP on 4/19/2021. She was feeling much better but not back to her baseline yet.
pt recv 5JAN95 & same day pt exp a light case of clinical varicella  p/exposure to wild type varicella through an outbreak in the community;pt devel approx 8 lesions;7 were erythematous & 1 was vesicular;that same day to MD;
Headache, Myalgia, Restless, Painful swollen left arm that is warm to touch no redness noted. Narrative:
headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.  On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, the patient experienced HEADACHE (headache). At the time of the report, HEADACHE (headache) outcome was unknown. Not Provided    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No relevant concomitant medications were reported.  No treatment information was provided.