chrisvoncsefalvay/vaers-outcomes huggingface dataset:
did not get second dose; started to get sick; covid-19; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (did not get second dose), ILLNESS (started to get sick) and COVID-19 (covid-19) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced ILLNESS (started to get sick) and COVID-19 (covid-19). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (did not get second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (did not get second dose), ILLNESS (started to get sick) and COVID-19 (covid-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Jan-2021, SARS-CoV-2 test: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were reported. Patient reported On 29-Jan-2021 she had an infusion to treat COVID-19.
* Fever and coughing, which is very rare at the first shot. My temperature was 38.3 C. The fever lasted for two days. But the coughing stayed for over a month. As of today (5/31/2021), I still cough occasionally.  * Fast heart beat. My normal heart beat is 57-60 per min. After the first shot, my heart beat went to 70 above, some times 80 and above. The fast heart beat stayed for weeks. That was why I was hesitant to take the second shot. Eventually I took the second shot on 5/26/2021, 33 days after the first shot. I did not have much side effect for the second shot, except sleepiness. Ironically, on 5/30/2021, I suddenly felt much better after getting up from the bed. I measure my heart beat, it was below 60, back to normal.  Fatigue.  I  did not feel the same as before after the first shot.  I felt fatigue. Un thet weenkend after my second shot,  I was back to normal. No fatigue any more.
Pt stated after her first Pfizer dose she did not have any adverse reactions that she could remember. Pt. was feeling normal prior to vaccination and stated she had a granola bar and some water for breakfast. Pt was sitting in chair when she alerted technicians about her symptoms. Pt. then stated she began to feel dizzy and lightheaded while sitting in the chair. When asked, pt. said her vision was clear and normal. Pt. has Hx of DM type II, HTN, seasonal allergies and asthma. We assisted pt. to floor in semi fowlers position with a pillow behind her head in position of comfort. I asked pt. if anyone was with her and she stated someone had dropped her off, but was alone currently. Pt. was alert and oriented to person, place and time. I asked if she would like us to call the squad and she responded yes. We called emergency personnel. Pt. was warm to touch, but was complaining of chills. Pulse was 88 bpm, respirations 14. Per pt. she has an allergy to lisinopril and is currently taking several prescription medications, but could not recall any names. Pt. began to notice some wheezing and I asked if she had an inhaler for her asthma. She self-administered 2 puffs of Ventolin which helped with her breathing symptoms. EMS arrived on scene and a brief Hx was given to the squad. EMS took vitals and loaded pt. on cot and transported to Hospital.
COVID vaccine series 01/25, Pfizer, dose #1 02/16, Pfizer, dose #2 11/09 COVID swab, result: detected department visit 10/30 pt cc: dyspnea exposure: unknown
Heart rate went up and down and was very irregular; Runny nose; Light Cough; Headache; Arm hurt a little bit; Felt a little sick; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE IRREGULAR (Heart rate went up and down and was very irregular), RHINORRHOEA (Runny nose), COUGH (Light Cough), HEADACHE (Headache) and PAIN IN EXTREMITY (Arm hurt a little bit) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (She was tested positive on 15-DEC-2020) on 15-Dec-2020.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced HEART RATE IRREGULAR (Heart rate went up and down and was very irregular), RHINORRHOEA (Runny nose), COUGH (Light Cough), HEADACHE (Headache), PAIN IN EXTREMITY (Arm hurt a little bit) and ILLNESS (Felt a little sick). On 14-Jan-2021, HEART RATE IRREGULAR (Heart rate went up and down and was very irregular), RHINORRHOEA (Runny nose), COUGH (Light Cough), HEADACHE (Headache) and PAIN IN EXTREMITY (Arm hurt a little bit) had resolved. At the time of the report, ILLNESS (Felt a little sick) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.
Muscle aches, queasy, chills, & fever (100.2) from 8:30pm Feb. 11 until around 2:00am Feb. 13. Mild sore throat Feb. 13 & 14. Pain at injection site Feb. 11 - 14.  Moderate fatigue Feb. 12 - 14.
Breakthrough covid.  first dose 7/25/2021, second 8/20/2021 and breakthrough 5/17/2022. Pt.  presented to Emergency Department, secondary to a syncopal episode.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 93-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2021 at 1:09 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 07-Jan-2021 at 1:09 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 93.74 years. No concomitant medications were reported. Batch number 025L20A  underwent temperature excursion on 07-Jan-2021 with temperature 34 degrees Fahrenheit at 10:00 AM to 11:00 AM .The vial was initially moved to the fridge on 05-Jan-2021 and proposed beyond use date was 27-Jan-2021. Product moved to clinic on 07-Jan-2021. 6 vials were sent to clinic. Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour. No treatment medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).
w/in 24hr of vax pt devel a pin-point, itchy rash on the trunk of body, legs & arms;treated self w/DPH & sx resolved w/in 1wk;this is 1 of 2 pt from this facility to devel a rash p/vax lot#4978206
went to observation area at 1045.  called to observation area 1100.  states sx started at 1055:  inside ears tingling, itching and warm.  sweaty armpits.  states has eaten peanutbutter, snacks and coffee for intake today.  not lightheaded, dizzy, states no other sx.  1102 seen by, RN from rapid response.  decided to wait 10 minutes to see if sx resolve.  1115 still no change in sx,  ed called and transported to ED at 1125.
pt recv vax; screamed & cried 8-10 hr about 6 hr p/ vax;
It was determine at 5:00pm that the patient was administered a Pfizer vaccine past the BUD/time.  Administered at 3:30pm on 9/23 from a vial that remained in the IMZ room from the previous day which was mixed on 9/22 at 12:14pm .  I observed the beyond use time of 6:14pm, however I did not verify the date.  Patient did not report any adverse reaction during administration or during the 15 minute wait period. Contacted Pfizer and was informed that there is no protocol for after 24 hours outside of BUD/time.  Consulting the Market Director and Clinical Services team for further guidance.
Approx 8 hours after vaccination I became ill with a very bad headache, nausea and extreme fatigue.  Late on 4/11 I felt much better.  While sleeping the night of 4/11 i woke drenched in sweat.  However, by Monday I was okay.   Then on Tuesday night I discovered a rash on my right leg. I have called my doctor's office to report this, but waiting to hear back. I do not have any other symptoms but am watching for symptoms associated with blood clots after J&J vaccination.
History of recent cystoscopy with transurethral resection of bladder tumor done by Dr. on 07/28/2021, the biopsy of which came back as squamous metaplasia without  any evidence of malignancy.  The patient says that she had hematuria for a few  days which then resolved, but then on 8/7/21 she started to have frank diarrhea and then  started to have gross hematuria along with lower abdominal pain and dysuria.   Therefore, came to emergency room where a CT abdomen and pelvis was done in  the ER which is showing changes consistent with hematuria.  Also, it shows  multiple  pulmonary nodules with metastatic disease not ruled out. Found to be COVID19 positive.  Treated with decadron, she was on room air and did not experience any symptoms. She was admitted for hematuria. Discharged 8/23/21
hives on trunk of body developed 2 weeks after second  pfizer covid vaccine. After a few months they faded and stopped itching. In October I received Pfizer booster, about 2 weeks later itchy hives came back on trunk of body.
No adverse effects reported / No AE/PQC; improperly stored dose of PEDVAX HIB was administered to the patient; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patients' concurrent conditions, past medical history, concomitant medications, and drug reactions or allergies were not reported.   On 19-JUN-2019, the patient received an improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (lot # R027328 and expiration date 12-JUL-2021) (dose and route of administration were not reported), for prophylaxis. The dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) was exposed to a total time and highest temperature excursion above 47 Fahrenheit degrees (°F)/9 Celsius degrees (°C) (47.4 F) during a timeframe of 1 hour and 30 minutes, which was detected by a data logger. There were no previous temperature excursions. No adverse events reported.
Child inadvertently given wrong influenza vaccine.  Should have gotten 3 years and up was given 6 months to 36 months.
Initial report was retrieved from the scientific literature on 06 September 2012. The following information is verbatim from the abstract: "Meningococci have historically caused extensive illness among members. Three successive meningococcal vaccine types were used from 1971 through 2010; overall disease incidence dropped by >90% during this period. During 2006-2010, disease incidence of 0.38 (cases per 100,000 person-years) among members was not significantly different from the incidence of 0.26 among the age-matched general population. Of the 26 cases, 5 were fatal, 15 were vaccine failures (e.g., illness in a person who had been vaccinated), and 9 were caused by Neisseria meningitidis serogroup Y. Incidences among 17- to 19-year-old were significantly higher than among comparison populations (p<0.05). No apparent change in epidemiology of meningococcal disease was observed after replacement of quadrivalent polysaccharide vaccine with conjugate vaccine in 2007. The data demonstrate that vaccination with meningococcal vaccine is effective." According to the report, the cases were confirmed by culture, PCR or both. The information included in this case concerns a 20-24 year-old male patient who had received MENACTRA (lot number, route, site and date of administration not reported) and one month after vaccination developed meningococcal sepsis, year reported as 2010 (Q 1). Neisseria meningitidis serogroup was determined to be serogroup Y. Treatments were not reported. No further information was available at the time of report. Death was reported as "No", however the patient's outcome was not reported. The reporter for this case is the same as for cases 2012-08240, -08241, -08242, -08243, -08244, -08245, -08246, -08247, -08248, -08249, -08251, -08252, -08253, -08254, -08255, and -08256. Documents held by sender: None.
swollen submaxillary lymph nodes, pt vax /w  1st dose occurred same day 4 hrs later. Resolved /w out treatment
unconsolable crying x 3 days;parent reports no fever;cried day & noc;
Pt recvd vax 13JUL92 & on 14JUL92 devel swelling & vesiculation @ the inject site; The lesions resolved w/o incident & the pt recovered;
huge bald spot on the side of her head/she has spots all around her head; alopecia Areta; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: (005570). The reporter is the parent.  A 6-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) at the age of 5 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ALOPECIA (non-serious), outcome "unknown", described as "huge bald spot on the side of her head/she has spots all around her head"; ALOPECIA AREATA (non-serious), outcome "unknown", described as "alopecia Areta". The events "huge bald spot on the side of her head/she has spots all around her head" and "alopecia areta" required physician office visit.  Additional information: The reporter wanted to know her daughter who is 6, she was 5 at the time of vaccination, now has alopecia Areta as a result of taking the vaccine. Her daughter has always had thick full hair and a just a few days after receiving the vaccine, she got 1 huge bald spot on the side of her head. Soon after and as of today she has spots all around her head. She saw a dermatologist, and it's so severe she has to see an Alopecia specialist.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
dizzy, profusely sweating, feeling like I was going to pass out, loss of color, felt unable to speak, felt vibrations throughout my entire body. Pharmacy (where I had the vaccine) called an ambulance who came and took me to the ER
PATIENT VACCINATED 2-27-07 WITH HEP A, PT. DEVELOPED RASH ALL OVER BODY 3-1-07.RASH GENERALIZED, PAPULAR AND MACULAR, ERYTHEMATOUS, SMALL NODULAR ERUPTIONS ON ELBOWS WITH SLIGHT URTICARIA. LAB WORK ORDERED AND WAITING ON RESULTS.
Pt c/o Headache, Neck pain, Rash on neck, Swollen nose, nausea, tiredness starting on 3-19-21 (day after vaccine), Pt seen in office on 3-23-21 and dx with adverse reaction, likely allergic reaction to vaccine, Kenalog 40mg IM x1 given. I recommended pt to cancel 2nd Moderna COVID-19 vaccine dose
More than 35 days between Moderna Covid-19 vaccinations.; fatigued; swollen lymph node under his lymph node; vomited; chills; nausea; shaking; sweating; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (shaking), HYPERHIDROSIS (sweating), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days between Moderna Covid-19 vaccinations.), CHILLS (chills) and NAUSEA (nausea) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048F21A and 002F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 07-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Sep-2021, the patient experienced TREMOR (shaking), HYPERHIDROSIS (sweating), CHILLS (chills) and NAUSEA (nausea). On 20-Sep-2021, the patient experienced VOMITING (vomited). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days between Moderna Covid-19 vaccinations.), FATIGUE (fatigued) and LYMPHADENOPATHY (swollen lymph node under his lymph node). At the time of the report, TREMOR (shaking), HYPERHIDROSIS (sweating), CHILLS (chills), NAUSEA (nausea), FATIGUE (fatigued), VOMITING (vomited) and LYMPHADENOPATHY (swollen lymph node under his lymph node) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days between Moderna Covid-19 vaccinations.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable  No concomitant medications reported. No treatment reported On an unknown date lab data includes Bloodwork and an Ultrasound results were pending.   This case was linked to MOD-2021-327904 (Patient Link).
13x16 cm area of erythema and swelling of left thigh with fever noted 48 hours after vaccine administration. Cephalexin 250 mg tid given empirically x 3 days with complete resolution of redness and swelling.
Woke up with closed eye and drooping on left side of face. ER diagnosis of Bells Palsy
Per patient report: 12/24/2010 a fever to 103 degrees.  On December 28 she again had a fever to 100 degrees.
w/in 1hr p/vax mom reported red rash raised & itchy on stomach, back, under neck, chin, armpits;no diff breathing;instructed to given DPH & apply caladryl;1/2hr later DPH given & caladryl applied;rash not devel anymore;
got shingles after my booster/suspected vaccination failure; shingles; severe vertigo; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 3 months after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and vertigo. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles and vertigo were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and vertigo to be related to Shingles vaccine.     Additional Information: GSK receipt date: 2-June-2022 Reporter's comment: This case was reported by a patient via interactive digital media. The patient got shingles after booster 3 months and counting. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced severe vertigo too.  Additional Supportive Information: This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles was not provided.
I have an allergy that has developed since I received the first two doses.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose 1, single and administration date 2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: HYPERSENSITIVITY (non-serious), outcome "unknown", described as "I have an allergy that has developed since I received the first two doses.".  Additional information: Patient received the first two doses this past summer and hoping to get a booster, but want to confirm the source of the  first after speaking with allergist.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Heart went into afib and flutter.  4 cardio versions  1 ablation to the heart
patient's wife reports fever, muscle aches, headache which started next day and lasted a few days but patient also experienced what looked liked chicken pox at the injection site and a few places on the body that occurred about one week later.
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 09-SEP-2015, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On or about 25-DEC-2016, the patient was treated for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
This spontaneous report as received from a licensed practical nurse refers to a multiple unspecified patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored doses of PNEUMOVAX23 (lot # L021367 exp date 05-NOV-2016) (dose and route not reported). No adverse effect was reported. This is one of several reports received from the same source. Additional information has ben requested.
mom stated pt had strong shaking episode on 22DEC96, 24DEC96, 27DEC96;no fever, eyes did not roll back, episodes lasting 12sec-whole upper body & lower extremities shook;
High blood pressure (165/100) requiring treatment with lisinopril, pain on right abdomen, raised red swollen rash on right arm one week after injection
Immediately p/MMR given, 1x1 cm hive @ site of inject, 1x1cm hive just below site, 3x4 cm area red & swollen @ site;
Patient presented with rash, onset AM of 3/18/13. Temp 99.2 degrees. Physical exam reveals erythematous papulovesicular rash predominantly on torso, particularly back; around 25 lesions total. Suspect associated with vaccine given 10 days ago. Symptomatic treatment; routine advice. Assume will resolve.