chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Narrative: COVID infection following COVID vaccine series 02/11, Pfizer, dose #1 03/04, Pfizer, dose #2 1/3 COVID swab, result: detected 12/25 pt cc: chills, cough, diarrhea, fever, loss or taste or smell exposure: unknown
Starting 07/01/2022, I had sinus drainage and family members informed me they were positive. So, I tested myself for COVID-19 and it was positive. Shortly after testing positive, I started sneezing and having symptoms resembling a bad cold: Congestion, sneezing and sinus drainage. I called my doctor the same day and I was prescribed Paxlovid. I took it as prescribed for 5 days. My oxygen levels were fine and I was not running a fever. On 07/02/2022, my symptoms were much less but I still was sneezing and had congestion. With each day, I got gradually better. On 07/10/2022, I tested myself again and I was negative. I stayed home but I felt mostly fine during this entire event and it was a very mild case.
Off-label use; Booster dose; Interchange of vaccine products; Tachycardia; dizziness; This is a spontaneous report from a contactable Other-HCP. This 27-year-old female Other-HCP (patient) reported for herself. A 27-year-old non-pregnant female patient (not pregnant at the time of vaccination) received third dose (booster) of BNT162B2 (PFIZER-BIONTECH COVID -19 VACCINE, solution for injection, Lot Number: FG3527, Expiry date: not reported) via an unspecified route of administration, on 05Nov2021 (27-year-old at the time of vaccination) as dose 3 (booster), single for COVID-19 immunization at pharmacy or drug store. The patient medical history was not reported. Concomitant medication(s) included ethinylestradiol, ferrous fumarate, norethisterone acetate (BLISOVI 24 FE) taken for an unspecified indication, start and stop date were not reported. The patient did not receive other vaccine in four weeks. Patient did not have any allergies. The patient previously took first dose of Moderna (MODERNA COVID-19 VACCINE, unknown formulation, Lot Number: 011L20A, Expiry date: not reported) via an unspecified route of administration, on 15Jan2021 (27-year-old at the time of vaccination) as dose 1, single for COVID-19 immunization and took second dose of Moderna (MODERNA COVID-19 VACCINE, unknown formulation, Lot Number: 031L20A, Expiry date: not reported) via an unspecified route of administration, on 12Feb2021 (27-year-old at the time of vaccination) as dose 2, single for COVID-19 immunization. On 05Nov2021, the patient takes booster dose and experienced tachycardia and dizziness. Events leads to emergency room and physician office visit. It was reported that patient developed tachycardia and dizziness occurring 5 to 6 minutes after receiving Pfizer vaccine. Symptom onset was sudden. Peak symptoms occurred for around one minute, and slowly decreased in severity over the course of 3 hours. The patient did not any receive treatment for the events. On an unspecified date, the patient recovered from the events tachycardia and dizziness and outcome of the other events was unknown.
Immediate weakness, nausea, and fatigue.  Then 6 weeks of low-grade fevers, chills, body aches,  nausea, progressing to shortness of breath, coughing and extreme fatigue.  One round of prednisone and zithromycin.
have covid; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (have covid) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (have covid). At the time of the report, COVID-19 (have covid) outcome was unknown.            No concomitant medications were reported. Patient got product (Paxlovid) and a little worried because had two Moderna Booster shot (COVID-19 Vaccine). Patient just wanted to find out that (Paxlovid) safe to take over that (Moderna COVID-19 Vaccine). Did not take these tablets at all. Had the Medication (Paxlovid) besides but had not taken.
No additional AE or PQC reported; VAQTA and RECOMBIVAX HB were administered after a temperature excursion; This spontaneous report as received from an office manager refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions, allergies and concomitant therapies was provided.  On 29-DEC-2021, after a temperature excursion, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) prefilled syringe, 0.5 ml, lot # U002749, expiry date 04-MAY-2022 (route and site of administration were not reported) and with and hepatitis b vaccine (recombinant) (RECOMBIVAX HB), 0.5 ml, lot # T007984, expiry date 01-NOV-2022 (route and site of administration were not reported), both for prophylaxis (product storage error). The vaccines experienced a temperature excursion, however a specific temperature and timeframe were unknown by the reporter. It was unknown if a previous temperature excursion occurred. No additional adverse event was reported (no adverse event).
Hospital course: 23 yo female with no significant PMH presenting to the ED with right sided CP, worse with deep inspiration.  Received 2nd covid vaccination last week- mild reaction with fever thereafter.  She had w/u in the ED including an EKG with inferior and septal TWI and trop of 1.61.  CTA chest was negative.  She was admitted.  After admit, troponin trended up (1.61--3.71--4.93).  CRP 49.1, ESR 21.   Echo showed apex hypokinesis so with TWI on EKG and elevated trop, cardiology elected for LHC.  This was normal.  Cardiac MRI showed myopericarditis. She was started on high dose ASA, colchicine and bblocker for this.  Likely viral etiology (Covid, Resp 4 plex negative).  Trop trended down on 4/13 (CRP still rising).  Cardiology was ok with discharge.  Will need 2 weeks of ASA and 3 months of colchicine.  No strenuous activities for that time frame.  She is getting her Masters in music/violin and did not need a return to school note.   Feeling somewhat better at discharge- rated pain 6/10.    Internal Medicine followup in 1 week Cardiology followup in 2 months
Injection site had leakage after fluid injection in right arm about two drops of vaccine; Injection site had leakage after fluid injection in right arm about two drops of vaccine; a localized red rash was observed at the site; a localized red rash was observed at the site; a localized red rash was observed at the site for several days following the injection accompanied with mild soreness; This spontaneous case was reported by an other health care professional and describes the occurrence of UNDERDOSE (Injection site had leakage after fluid injection in right arm about two drops of vaccine), DEVICE CONNECTION ISSUE (Injection site had leakage after fluid injection in right arm about two drops of vaccine), VACCINATION SITE ERYTHEMA (a localized red rash was observed at the site), VACCINATION SITE RASH (a localized red rash was observed at the site) and VACCINATION SITE PAIN (a localized red rash was observed at the site for several days following the injection accompanied with mild soreness) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     The patient's past medical history included Acute bronchitis from 20-Jan-2021 to 01-Mar-2021 and Hashimoto's disease on 01-Aug-1998. Concomitant products included LEVOTHYROXINE and LIOTHYRONINE for Hypothyroidism.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced UNDERDOSE (Injection site had leakage after fluid injection in right arm about two drops of vaccine), DEVICE CONNECTION ISSUE (Injection site had leakage after fluid injection in right arm about two drops of vaccine), VACCINATION SITE ERYTHEMA (a localized red rash was observed at the site), VACCINATION SITE RASH (a localized red rash was observed at the site) and VACCINATION SITE PAIN (a localized red rash was observed at the site for several days following the injection accompanied with mild soreness). On 17-Mar-2021, UNDERDOSE (Injection site had leakage after fluid injection in right arm about two drops of vaccine) had resolved. At the time of the report, DEVICE CONNECTION ISSUE (Injection site had leakage after fluid injection in right arm about two drops of vaccine), VACCINATION SITE ERYTHEMA (a localized red rash was observed at the site), VACCINATION SITE RASH (a localized red rash was observed at the site) and VACCINATION SITE PAIN (a localized red rash was observed at the site for several days following the injection accompanied with mild soreness) 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.   Patient taken oral NSAIDS for her events. No relevant concomitant medication was reported. .   Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Patient demographics, vaccine facility information ,medical history, concomitant medication and new events were added.
This is a spontaneous report from a contactable consumer reporting on behalf of her son. A 15 years old male patient received first dose of TRUMENBA on 15May2015 at 4:45 P.M. at 0.5 ml single to prevent meningitis. Medical history included Asperger's disorder diagnosed several years ago, maybe in 2012 (before that they thought it was ADHD). Concomitant medications included ZOLOFT at 250 mg, VYNASE at 60 mg and calcium carbonate, CALTRATE SELECT gummies daily and gummy laxative do not know brand. On 18May2015 the patient experienced muscle ache in neck, headache, low fever, hives on both arms. The mother was sick for the last 4 days; she thought he had received a cold from her. The patient was recovering from hives. Outcome of the other reported events was not resolved. Follow-up (15JUL2015): Follow-up attempts completed. No further information expected.
Muscle around the vaccination site is very swollen. Around 1.5 inches in diameter across most swollen part. Very red and raised. Patient said it was very painful all around. Patient said it started around 1 day after getting vaccine Flucelvax.
Received the vaccine in the late morning. That evening develop pain, swelling, and a rash to arm. It was very pain. The rash was splotchy, red, itchy. Started in the upper arm and is moving down. The swelling was significant initially but is better today. Started on antihistamine, motrin, warm compresses. Is due to f/u tomorrow.
This spontaneous prospective pregnancy report was received from a healthcare worker refers to a 18 year old female patient. No medical history and drug reactions were reported. On 10-JUN-2013, the patient received her first dose of GARDASIL and on 13-AUG-2012, the patient received second dose of GARDASIL (lot # H021608, expiry: 13-AUG-2015), 0.5 ml, intramuscularly and then it was determined that the patient was pregnant wit LMP of 15-JUl-2013 and EDD of 21-APR-2014. No concomitant medications were reported. On 12-AUG-2013, a pregnancy urine test was positive. No medical attention was sought. The pregnancy outcome was pending. No adverse effect reported. Additional information has been requested.
Patient had a breakthrough infection, positive COVID test on 12/30/2021. Patient passed away.
The crappy week we had; This case was reported by a consumer and described the occurrence of malaise in a 60-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced malaise. On an unknown date, the outcome of the malaise was recovered/resolved.   It was unknown if the reporter considered the malaise to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received the Shingles shot and had almost every side effect they said could happen and had a crappy week. The patient stated that it was much better than what the patient's dad went through when he had shingles, within 12 hours of breakout he spiked a high fever and was admitted to isolation with meningitis that within another 12 hours he had encephalitis. He died 6 weeks later due to kidney failure from the all the antibiotics to cure him .  The patient would encourage everyone to get this vaccine. This case was linked with US2021AMR227919, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR227919:Same reporter US-GLAXOSMITHKLINE-US2021AMR227919:Same reporter
Blacked out on day 2, 24+hrs after dose 2; This is a spontaneous report from a contactable consumer (patient).  A 13-year-old female patient received second dose of BNT162B2 via an unspecified route of administration at arm right on 06Jun2021 10:30 (age at 13 years old, Batch/Lot Number: Ew0191) as single dose for COVID-19 immunisation. The patient had no known allergies and other medical history. The patient received first dose of BNT162B2 on 16May2021 10:30 (lot number Ew0185) at arm right for COVID-19 immunisation. There were no concomitant medications. No other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. The patient experienced blacked out on day 2, 24+hrs after dose 2 on 07Jun2021 13:00. No treatment received. The outcome of the event was recovered on an unspecified date.  Follow-up attempts are completed. No further information is expected.
Acute blood loss anemia. ED visit and hospital admission. These visits were within 6 weeks of receiving vaccine.
Circumstance or information capable of leading to a medication error; Extra dose administered; Drug dose administration interval too long; shingles; sensitivity around his waist; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 82-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis and Herpes zoster (Shingrix) for prophylaxis.   In February 2018, the patient received the 1st dose of Shingrix. In November 2018, the patient received the 2nd dose of Shingrix. On an unknown date, the patient received the 3rd dose of Shingrix. In October 2018, 244 days after receiving Shingrix and not applicable after receiving Shingrix and Shingrix, the patient experienced shingles and sensitive skin. In November 2018, the patient experienced drug dose administration interval too long. On an unknown date, the patient experienced circumstance or information capable of leading to medication error and extra dose administered. On an unknown date, the outcome of the shingles was not recovered/not resolved and the outcome of the sensitive skin, drug dose administration interval too long, circumstance or information capable of leading to medication error and extra dose administered were unknown.   It was unknown if the reporter considered the shingles and sensitive skin to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. Prior to the 2nd dose, in October 2018, less than a year after receiving Shingrix, the patient developed a sensitivity around his waist that was later diagnosed as an isolated mild case of shingles with no rash.  The patient received the 2nd dose in November of 2018 later then the recommended schedule, which led to the lengthening of the vaccination schedule. The patient was working with his physician to get a 3rd dose of Shingrix, which led to the circumstance or information capable of leading to a medication error and extra dose administered. There is a discrepancy with respect to outcome of the event mild case of shingles. As per reported in the structural field it is not recovered; however, as per source document it is recovering/resolving. Retain not recovered as per the structural field.
This spontaneous report was received from a registered nurse concerning to a product confusion report. Nurse reported that M-M-R II with lot number K024825 (expiration date 02-DEC-2016) and lot number L003855 (expiration date 05-FEB-2017) was stored at room temperature by a health care worker. Reporting nurse stated t hat the healthcare worker must have mistaken the M-M-R II for sterile water diluent and therefore believed it could be stored at room temperature. The nurse felt that the confusion likely occurred due to the fact that the packaging for the M-M-R II and the sterile water diluent are identical in color when viewed from the side. No dose of either the product was administered to any patient and therefore there was no adverse effect to report. Additional information has been requested.
Extremely, extremely dizzy; Lost his balance; Had a serious fall; Fell and hurt himself; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Extremely, extremely dizzy), BALANCE DISORDER (Lost his balance), FALL (Had a serious fall) and INJURY (Fell and hurt himself) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) 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 DIZZINESS (Extremely, extremely dizzy), BALANCE DISORDER (Lost his balance), FALL (Had a serious fall) and INJURY (Fell and hurt himself). At the time of the report, DIZZINESS (Extremely, extremely dizzy), BALANCE DISORDER (Lost his balance), FALL (Had a serious fall) and INJURY (Fell and hurt himself) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. Treatment medications were unknown.    Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: Follow-up information received on 03-JUN-2021 contains significant information: Added new event "Hurt".
some axillary tenderness; some localized site tenderness; swollen lymph nodes; This is a spontaneous report from two contactable Other HCPs. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 23Dec2020 at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced some localized site tenderness, some axillary tenderness in the days after the vaccine and then symptoms went away. The past couple of days she was experiencing extremely swollen lymph nodes and an ultrasound confirmed this. No other symptoms at this time. The outcome of events some axillary tenderness and some localized site tenderness was recovered; of event swollen lymph nodes was unknown.  Information on lot number/batch number has been requested.
Cellulitis; Treated with cephalexin 500 mg BID x 14 days.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown ages and genders. No medical history, concurrent conditions or concomitant medications were reported. On an unknown dates, the unspecified number of patients were vaccinated with improperly stored doses of GARDASIL (strength, dosing regimen, anatomical location, lot number and expiration date were unknown) for prophylaxis. Also, it was reported that all vaccines were considered "okay" for use with the exception of the M-M-R II (case # 1609USA014777). All vaccines that were in inventory at the time of the excursion that were "okayed" for use after review with the respective pharmaceutical companies were marked with Black X to designate exposure. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1609USA014777: US-009507513-1609USA014778: US-009507513-1609USA013289.
redness; itching; This case was reported by a consumer via call center representative and described the occurrence of erythema in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   In August 2019, the patient received the 1st dose of Shingrix. In August 2019, less than a month after receiving Shingrix, the patient experienced erythema and pruritus. On an unknown date, the outcome of the erythema and pruritus were not recovered/not resolved.   It was unknown if the reporter considered the erythema and pruritus to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient had redness and itching from the Shingrix vaccine. It has been 10 days.
My reaction was within a couple of hours of getting 2nd vaccine, I experienced extreme fatigue and could not stay away. I proceeded to sleep for the next 24 hours. I started experiencing Shortness of breath; My reaction was within a couple of hours of getting 2nd vaccine, I experienced extreme fatigue and could not stay away. I proceeded to sleep for the next 24 hours. I started experiencing Shortness of breath; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 46-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported and expiry date: unknown), dose 2 via an unspecified route of administration, administered in Arm Left on 16Mar2021 at 11:00 as DOSE 2 (age at vaccination: 46-years-old), SINGLE for covid-19 immunisation. Medical history included food allergy (Shellfish). The patient's concomitant medications were not reported. The patient received dose 1 of bnt162b2 on 23FEB2021 for COVID-19 Immunisation (administration time: 10:00 AM, vaccine location: Left arm). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced my reaction was within a couple of hours of getting 2nd vaccine, I experienced extreme fatigue and could not stay away. I proceeded to sleep for the next 24 hours. I started experiencing shortness of breath on 23Mar2021. The patient did not receive any treatment for the events. Adverse events resulted in: Doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 11Jun2021, sars-cov-2 test: negative on 11Jun2021. Outcome of the events My reaction was within a couple of hours of getting 2nd vaccine, I experienced extreme fatigue and could not stay away. I proceeded to sleep for the next 24 hours. I started experiencing Shortness of breath (Fatigue extreme) was Not recovered (the extreme fatigue continues to be a daily issue and only appears to be worse), My reaction was within a couple of hours of getting 2nd vaccine, I experienced extreme fatigue and could not stay away. I proceeded to sleep for the next 24 hours. I started experiencing Shortness of breath (Shortness of breath) was Recovering (While the shortness of breath seems to be dissipating slowly over the last couple of weeks).
Patient developed a fever, nasal congestion and ear ache on 4.7.2021 and a positive COVID-19 test on 4.8.2021
Patient is 17 years old and received the first dose of Moderna as an administration error due to her age.
Patient admitted to Hospital on 4/19/21 for bilateral pulmonary embolisms.