chrisvoncsefalvay/vaers-outcomes huggingface dataset:
could not get the second dose, got the flu, and now she is going to get 2 months after; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (could not get the second dose, got the flu, and now she is going to get 2 months after) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (could not get the second dose, got the flu, and now she is going to get 2 months after). On 12-Jan-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (could not get the second dose, got the flu, and now she is going to get 2 months after) had resolved. Not Provided      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 concomitant medications or treatment details reported.
Pt exp slight fever following 1st dose of HIB/DTP; Given 2nd dose of HIB which, p/being mixed w/ appropriate diluent, had accidentally been mixed w/ DTP into one syringe; @ time of report pt exp sl fever;
pt was given DTP pt cried a short time, red, flat, spotty rash appeared on forehead; pt already had a rash on chin & neck from sucking on fingers;
No additional AE reported; patient was administered with improper stored dose of PROQUAD; This spontaneous report has been received from a registered nurse concerning 5-years-old female patient. The patient's medical history, concurrent conditions, concomitant medications, previous drug reactions and allergies were not provided.   On 27-SEP-2021, the patient was vaccinated with improperly stored measles, mumps, rubella, and varicella (Oka-Merck) virus vaccine live (rHA) (PROQUAD) injection, administered subcutaneously, in the left arm, lot number T012419 had been verified to be a valid number; expiration date reported and validated as 06-OCT-2021, for prophylaxis (dosage and frequency were not provided) (product storage error). There was a previous temperature excursion on 25-OCT-2020. No additional adverse events were reported in the patient.  This is one of several reports received from the same reporter, ; Sender's Comments:  US-009507513-2207USA002212:
Fever; chills; lethargy; This is a spontaneous report from a contactable consumer (patient). A 41-years-old female patient received bnt162b2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL9266, expiration date: May2021) via an unspecified route of administration in Arm Left on an unspecified date in 2021 (at the age of 41 years old) as dose 2, single for Covid-19 immunisation. Patient medical history and concomitant medications were not reported. Historical vaccine included bnt162b2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL9262) via an unspecified route of administration in Arm Left on 23Jan2021 (at the age of 41 years old) as dose 1, single for Covid-19 immunisation and due to it patient experienced swollen left armpit, swollen left neck. The vaccination facility was hospital, was not administered at military facility, from prior vaccinations there were no adverse events. The adverse events did not require a visit to emergency room and physician office. On an unspecified date in 2021, the patient experienced Fever, Chills, Lethargy. No Relevant Tests reported. There are no predisposing factors and no culture performed. The outcome of all the events was unknown.  No follow-up attempts are possible. No further information is expected.
Extreme dizziness followed by nausea.  Most severe Oct. 24, 2008 after I got the vaccine.  I was still dizzy Oct. 25, 2008 but not as bad.  I started to feel less dizziness on Oct. 26, 2008.
Information has been received from a lab technician concerning a female patient "in her 60s" who on 23-SEP-2009 was vaccinated with a dose of PNEUMOVAX 23 vaccine, (Lot# 662841/0626Y) 0.5 ml, IM. On 23-SEP-2009 the patient experienced injection site reaction of soreness, redness and hot to touch. The patient has sought medical attention at physician's office on 24-SEP-2009 and was advised to apply compress to the area. Lab technician did not know if the patient had received PNEUMOVAX 23 vaccine in the past. At the time of this report, the patient was not recovered. This is one of several reports received from the same source. Additional information has been requested.
This spontaneous report as received from a radiology technician refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 17-MAR-2016, the patient was vaccinated with an improperly stored dose of VARIVAX injection (lot# L016123, expiration date 06-MAY-2017; dose, anatomical location and route of administration were not reported). No adverse events were reported. Temperature was 10.6 degrees Fahrenheit for 9 days. The data logger was involved and there was no previous temperature excursion reported. This is one of several reports received from the same reporter. Additional information has been requested.
Aplastic anemia; This is a literature report for the following literature source(s): "APLASTIC ANEMIA FOLLOWING THE SARS-COV-2 VACCINE",(Supplement 3), pgs:1339-1340, DOI:10.1097/01.HS9.0000852292.38263.b8.  A male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "pancytopenia" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Sars-cov-2 vaccine (Dose 1, Manufacturer unknown), for Covid-19 immunisation, reaction(s): "no adverse reaction". The following information was reported: APLASTIC ANAEMIA (medically significant), 3 weeks after the suspect product(s) administration, outcome "unknown", described as "Aplastic anemia". The patient underwent the following laboratory tests and procedures: Aspiration bone marrow: Unknown results; Biopsy: Unknown results; Unknown results; Cytogenetic analysis: diploid karyotype, notes: showed a diploid karyotype with no chromosomal abnormalities; Diagnostic procedure: No abnormalities, notes: did not show any abnormalities; Flow cytometry: No abnormalities, notes: did not show any abnormalities; baseline characteristics: Unknown results; Unknown results. Therapeutic measures were taken as a result of aplastic anaemia.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of the reported event APLASTIC ANAEMIA Cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Information has been received from a medical assistant concerning a 13 year old female who on 18-AUG-2008 was vaccinated with a first dose of ZOSTAVAX (Oka/Merck) (lot# 658085/0882U) instead of VARIVAX (Oka/Merck) (administration site not reported).  According to the medical assistant, both vaccines were stored next to each other and she did not double check to make sure she was getting the correct vaccine to be administered.  It is not a PQC but a human error.  The patient's mother called the office to report that on 19-AUG-2008 and 20-AUG-2008 the patient developed a fever for a couple of days.  The outcome of the fever was reported as recovered.  Additional information has been requested.
Feeling fullness in tongue and cheeks; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): GL-030422-5619.  A 43 year-old female patient received bnt162b2 (BNT162B2), administration date 16Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single, administration date 05Apr2021 (Batch/Lot number: unknown) as dose 2, single and administration date 14Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; botulinum toxin type a haemagglutinin complex (DYSPORT), since 03Mar2022 (Batch/Lot number: unknown). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FEELING ABNORMAL (non-serious) with onset 03Mar2022, outcome "unknown", described as "Feeling fullness in tongue and cheeks". The action taken for botulinum toxin type a haemagglutinin complex was unknown.  Additional Information: Reference is made to the FDA Guidelines for Post-marketing Reporting of Adverse Drug Experiences (Docket No. withheld) dated Mar1992, requires "Reports of ADEs in which the initial reporter identifies the suspect drug as one marketed by another applicant should be promptly forwarded to that applicant." Female reports fullness in her tongue and inside of her cheeks. She denies any rash, shortness of breath or difficulty swallowing. Female reports that she has had Dysport in the past with another provider and did not experience any symptoms.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report as received from a pharmacist refers to a 4 months old patient of unknown gender. The patient was vaccinated with a dose of live, oral ROTATEQ (lot # 669570/1456AA; expiry date 03-OCT-2012) on 17-OCT-2012. Route was not reported. ROTATEQ was administered 2 weeks after the expiration date. No adverse effect was reported. Additional information has been requested.
After vaccination, complained of tongue feeling thick and being lightheaded.  Benadryl 25mg PO administered and patient observed by onsite RN and paramedic.  Pt improved and safely discharged home.
pt recv vax 30OCT98 & felt extremely tired;devel sore throat, chills, felt like was coming down w/flu;sudden onset @ 7PM left for hosp;blotches of redness on face & throat @ hosp diff breathing,dyspnea;bronchospasm, throat & chest tightness
Approximately 1:10pm began sweating profusely.  Complaints of SOB and throat "scratchy".  Increased respiratory rate noted in the 30's.  Breath sounds diminished bilaterally.  Gray pallor. Given epi 3mg at approximately 1:15pm with positive response.  Transported via ambulance to hospital.
Patient came in for Shingrix vaccine but the pharmacist gave patient the pfizer bivalent booster by mistake.
The vial of the vaccine was initially stored in the refrigerator on 28-Jan-2022 and administered to patient on 09-Mar-2022; Expired vaccine administered to one patient after 30 days use by date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to one patient after 30 days use by date) and PRODUCT STORAGE ERROR (The vial of the vaccine was initially stored in the refrigerator on 28-Jan-2022 and administered to patient on 09-Mar-2022) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 027L21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 09-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to one patient after 30 days use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial of the vaccine was initially stored in the refrigerator on 28-Jan-2022 and administered to patient on 09-Mar-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to one patient after 30 days use by date) and PRODUCT STORAGE ERROR (The vial of the vaccine was initially stored in the refrigerator on 28-Jan-2022 and administered to patient on 09-Mar-2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.  The vial had not undergone any temperature excursions. The healthcare provider wanted to get directions on what to do with the patients, and asked if they should repeat the dose of the patients.   This case was linked to MOD-2022-509838, MOD-2022-509900, MOD-2022-509902, MOD-2022-509907 (Patient Link).
Vial had expired 1 day previous on 8-31-21 and Vaccine given on 9-1-21.   No adverse reactions
sore Throat; Difficulty Breathing; Coughing; Chills; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore Throat), DYSPNEA (Difficulty Breathing), COUGH (Coughing) and CHILLS (Chills) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M24A) for COVID-19 vaccination.     Concurrent medical conditions included COPD, Thyroid disorder and Diabetes.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced OROPHARYNGEAL PAIN (sore Throat), DYSPNEA (Difficulty Breathing), COUGH (Coughing) and CHILLS (Chills). At the time of the report, OROPHARYNGEAL PAIN (sore Throat), DYSPNEA (Difficulty Breathing), COUGH (Coughing) and CHILLS (Chills) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, SARS-CoV-2 test: Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included medication for COPD, Diabetes and thyroid. The patient went to the Urgent Care and was treated for an upper respirator infection.
Patient received the vaccine at work and it was administered by a nurse at the school where he works. He became ill the day following the vaccine with fever, vomiting and diarrhea. The diarrhea lasted 3 additional days and vomiting ceased after the first day. By the fifth day of his illness his wife noticed him to be very yellow appearing and his yellow hue dissipated over the next 48 hours. He was mildly jaundiced when I examined him on 3/9/2004. Of note he was exposed to his grandchildren who were ill with similar GI sx's and there has been much of the same type of illness going around the community, thought to be a Norwalk Virus.
vomiting; not feeling well; chills; body aches/body hurting; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 10 year-old female patient received bnt162b2 (BNT162B2), administered in arm, administration date 16Dec2021 (Lot number: FK5618) at the age of 10 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PAIN (non-serious) with onset 19Dec2021, outcome "unknown", described as "body aches/body hurting"; VOMITING (non-serious) with onset 20Dec2021, outcome "recovered" (20Dec2021), described as "vomiting"; MALAISE (non-serious) with onset 19Dec2021, outcome "unknown", described as "not feeling well"; CHILLS (non-serious) with onset 19Dec2021, outcome "recovering", described as "chills". Therapeutic measures were taken as a result of pain, vomiting, malaise, chills.  Additional Information:chills got better after some medicine (Tylenol.) and was given Mucinex Cold and Flu 266mg from a cap with measurement then vomiting stopped after the medicine, patient only vomited a little.  No follow-up attempts are possible. No further information is expected.
I woke up with a rapid and oddly strong heart pounding in the middle of the night. This made me really concerned about my heart. This then was something that started happening at random times, but I noticed that my heart rate was overall higher by ten to thirty beats per minute. After about three months I reached out to my health care provider, and they did an EKG and had me wear a Holter monitor to track my heart rate. This only started occurring after having my COVID-19 booster. I do not really have a base line to compare my heart rate to before getting the shot, but it has been higher, and I now track and monitor my heart rate because of this experience. It had been high enough that I could notice it was higher and it was off. At this point I would say I am about 98% better and my heart rate is closer to where it should be and not as high as it had been. This has me worried about getting another dose of a COVID-19 vaccine.
Feeling very fatigued, headache, fever, chills, stomach pain, nausea, jittery, rash
vaccine used past the 12 hour window of use after vial punctured. Stored in fridge entire time and cleaned between each use with alcohol. second dose given 7/23/21 also given past 12 hour window Pt contacted and no adverse reaction, pt states no problems
Tested weakly positive for COVID-19; Pretty bad headache; A spontaneous report was received from a female consumer who received Moderna's COVID-19 vaccine and experienced a weakly positive COVID-19 test and headache.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 26 Dec 2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch: unknown) for prophylaxis of COVID-19 infection.     On 26 Dec 2020, the patient received her vaccine. On 29 Dec 2020, the Tuesday after she developed a pretty bad headache. The patient also was tested for COVID-19 on an unknown date. The results showed weakly positive for COVID-19 virus. No treatment information was provided.  Action taken with the second dose of mRNA-1273 in response to the event was unknown.   The outcome for the events, a weakly positive COVID-19 test and headache was not provided.; Reporter's Comments: Based on the current available information and the mechanism of action of mRNA-1237 vaccine, the events of Covid-19 is assessed as unlikely related.  The causality for the event of headache remains possible.
This case was reported by a consumer via a pharmacy claims management company and described the occurrence of adverse event(s) in a female subject of unspecified age who was vaccinated with FLUARIX TETRA (GlaxoSmithKline). A physician or other health care professional has not verified this report. On 3 October 2013 the subject received a dose of FLUARIX TETRA (unknown). On an unspecified date in 2013, within months after vaccination with FLUARIX TETRA, the subject experienced adverse event(s). At the time of reporting the outcome of the event(s) was unspecified.
1 week after vaccination pt began with lower ab pain and vaginal spotting.  estimated gestational age 10w1d by u/s.
Information has been received from a physician concerning a 21 year old female who on 13-FEB-2008 was vaccinated with GARDASIL.  Concomitant therapy included MENACTRA, VARIVAX and DTaP (unspecified).  On 13-FEB-2008 the patient fainted.  Subsequently, the patient recovered "pretty quickly" after fainting.  Additional information has been requested.
Pt presented with large, red, tender swelling approx. 3" diameter on left upper arm (delt.). Mom says pt was given IM vaccination at this site on 4/21/03. MD advised Benadryl po.
Patient states on Sat 9-14-13 (RA) swollen, red, tender then upper lip was swollen but no respiratory problems, hives or temperature. Patient stated he took 2 doses of BENADRYL in 12 hours and 1 dose of ZYRTEC. Symptoms were resolved by 10pm on 9/14/13. As of today 9/16/13 (RA) slightly red, swollen.
On 3/13/21, a rash formed at the injection site that is red, swollen, and itchy.
Caller said he felt like he got hit by a truck; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Caller said he felt like he got hit by a truck) 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 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (Caller said he felt like he got hit by a truck). At the time of the report, FEELING ABNORMAL (Caller said he felt like he got hit by a truck) outcome was unknown.            No concomitant medications reported. No treatment medications reported.   This case was linked to MOD-2021-306383 (Patient Link).
Fever <101 Muscle aches, flu-like symptoms, fatigue, severe headache.  EDD 5/12/2021. 25 weeks gestation: No obstetrical issues. No bleeding, cramping or decreased fetal movement.
Lost weight; Decreased appetite; Forgetfulness; Hidradenitis suppurativa; Headache; This spontaneous case was reported by a consumer and describes the occurrence of WEIGHT DECREASED (Lost weight), DECREASED APPETITE (Decreased appetite), MEMORY IMPAIRMENT (Forgetfulness), HEADACHE (Headache) and HIDRADENITIS (Hidradenitis suppurativa) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Hidradenitis suppurativa.    No Medical History information was reported.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. In March 2021, the patient experienced HEADACHE (Headache). On an unknown date, the patient experienced WEIGHT DECREASED (Lost weight), DECREASED APPETITE (Decreased appetite), MEMORY IMPAIRMENT (Forgetfulness) and HIDRADENITIS (Hidradenitis suppurativa). At the time of the report, WEIGHT DECREASED (Lost weight) and HEADACHE (Headache) was resolving, DECREASED APPETITE (Decreased appetite) and MEMORY IMPAIRMENT (Forgetfulness) outcome was unknown and HIDRADENITIS (Hidradenitis suppurativa) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Weight decreased: Body weight: Lost.         Concomitant drugs not reported. Dose for Moderna vaccine was given as 1 in 1 Once and HUMIRA as Citrate Free. No medical history was reported. It was unknown if patient was enrolled in a COVID-19 vaccine trial. For HUMIRA, the reporter causality for the events of Decreased appetite, Headache and  Hidradenitis was no reasonable possibility and the reporter causality for the events of Lost weight, Forgetfulness was not provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in. Treatment drugs not reported.   Reporter did not allow further contact