chrisvoncsefalvay/vaers-outcomes huggingface dataset:
MISCARRIAGE; SWELLING OF LEFT ARM; VACCINE EXPOSURE BEFORE PREGNANCY; VACCINE EXPOSURE DURING PREGNANCY; This spontaneous report received from a consumer (mother) concerned a 32 year old female of unspecified race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.  The patient previously received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: Unknown) dose was not reported, dose number in series 1, 01 in total, administered on an unspecified date in 2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch number. No concomitant medications were reported.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient additionally received non-company suspect vaccine BNT 162 (Comirnaty) (form of admin, route of admin was not reported, batch number: Unknown, expiry: Unknown) dose was not reported, dose number in series 2, administered at left arm on 14-DEC-2021 for prophylactic vaccination On an unspecified date in DEC-2021 (about 2 weeks after vaccination), the reporter discovered her daughter (patient) was pregnant (vaccine exposure before pregnancy and vaccine exposure during pregnancy) (dose number in series 1). On an unspecified date in DEC-2021, the patient experienced swelling of left arm and she had been suffering for last one month (dose number in series 2). The patient stated that her right arm was fine. On an unspecified date, the patient went to her regular doctor (physician's office) and did blood work. Laboratory data (dates unspecified) included: Blood test (NR: not provided) Normal. On 21-JAN-2022, the patient had miscarriage (dose number in series 2). Reporter stated her daughter had gone to two different doctors and one said the vaccine caused the miscarriage and the other one said that it did not cause the miscarriage The action taken with bnt 162 was not reported. The patient had not recovered from swelling of left arm, and the outcome of miscarriage, vaccine exposure before pregnancy and vaccine exposure during pregnancy was not reported (dose number in series 2). This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220201185- covid-19 vaccine ad26.cov2.s  Miscarriage. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: CONMEDS-OTHER SUSPECT DRUGS, NATURE OF EVENT.  20220201185-covid-19 vaccine ad26.cov2.s- vaccine exposure before pregnancy,  vaccine exposure during pregnancy This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
I received dose 3 in Oct 2021 and in January 2022, I started noticing extreme fatigue. I had no other symptoms. I talked to my doctor sometime in March 2022 about the extreme fatigue. They ordered bloodwork and they stated my electrolytes were a little low but that is not a new problem for me. I have had labwork done probably twice since the initial one with basically same result. I had an in home sleep apnea test this past June 2022. It shows that I had sleep apnea but again, that is nothing new for me as I have already been using a CPAP machine for 20 years. I do have a CPAP titration study to be done in late August 2022. I also have a Chest Cat Scan scheduled for Sept 18, 2022.
got sick [after first dose]; first dose >35 days ago , she couldn't go back to get the second dose. She still hasn't gotten the second dose.; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (got sick [after first dose]) and PRODUCT ADMINISTRATION INTERRUPTED (first dose >35 days ago , she couldn't go back to get the second dose. She still hasn't gotten the second dose.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 24-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (got sick [after first dose]) and PRODUCT ADMINISTRATION INTERRUPTED (first dose >35 days ago , she couldn't go back to get the second dose. She still hasn't gotten the second dose.). At the time of the report, ILLNESS (got sick [after first dose]) and PRODUCT ADMINISTRATION INTERRUPTED (first dose >35 days ago , she couldn't go back to get the second dose. She still hasn't gotten the second dose.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. No treatment medication was reported.
Patient had a Pneumovac 23 immunization given on 09/20/2019 at the time of the visit.  Pt called to report to provider at 8:00 pm Friday evening that she had started to have excruciating pain  to her RT arm.  Pt stated to the provider she had minimal redness noted to the area and had applied ice and took some OTC pain medication .  Pt stated after she left the clinic after getting her immunization she headed back to work and did 3 pedicures as she works in a beauty salon.  Pt then indicated that later that evening she was unable to lift her arm to eat.   Provider recommend to have the pt take Benadryl and continue to ice that arm.   Provider requested to have the pt contact her the next day to report how she was doing.  The next morning the patient stated to provider that she had no worsening of symptoms , but no change.  Later that evening the pt stated she was able to attend an event where she was scheduled to serve food and was able to participate in the activity.  The provider requested to have pt continue to notify her how she was doing.  Monday am the provider attempted to contact her to have pt schedule a follow up to be reassessed and provider was unable to reach the pt at the time.  She made several attempts to contact her by phone and by text message.  Provider states the pt did mention to her that her landline was out of service for the last few months .  Provider states that pt lives in a rural area that cell service does not always work.
side effects so worse than the flu; whole month with high fever; Initial information was received on 23-Nov-2020 regarding an unsolicited valid non-serious case from a consumer (patient) via social media.  This case involves a patient (unknown demographics) who experienced side effects so worse than the flu (unevaluable event) and whole month with high fever (pyrexia), while received INFLUENZA VACCINE.  Medical history, past medical treatment, vaccination, family history and concomitant medications were not provided.  On an unknown date, the patient received an INFLUENZA VACCINE (Produced by unknown manufacturer) (lot number, expiry date and other dosing details were not reported) for prophylactic vaccination.  On an unknown date, patient had experienced side effects so worse than the flu (unevaluable event) and whole month with high fever (pyrexia, following the administration of INFLUENZA VACCINE.   Details of laboratory data not reported.  Corrective treatment and outcome were unknown at the time of reporting.  There will be no information available on the batch number for this case.
This is a spontaneous report from a non-contactable consumer reporting for her daughter. A female patient of unspecified age and ethnicity/race received 3rd dose of TRUMENBA, via an unspecified route of administration, on an unspecified date, at single dose, for immunisation. Relevant medical history and concomitant medications were not reported. The patient experienced little red patch below the injection site; patch was bigger than the size of hand, it spread and was red warm and itchy all on an unspecified date with outcome of unknown. The reporter stated that below the injection site the patient had kind of size of a small orange like a little red patch but since then it spread and was really big itchy and bigger than hand. The reporter called the patient's pediatrician and dermatologist, the dermatologist put her on antibiotic. No follow-up attempts needed. No further information expected.
supress my immune system; I was given 2 shots of sangria in 2018 6 months apart / came down with shingles (diagnosed by a doctor); Shingles; This case was reported by a consumer and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis and omalizumab (Xolair) for anaphylaxis.   Concurrent medical conditions included anaphylaxis.   On an unknown date, the patient received the 1st dose of Shingrix, the 2nd dose of Shingrix and Xolair at an unknown dose and frequency. In February 2020, less than 2 years after receiving Shingrix and 2 years after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the patient experienced immune system disorder. On an unknown date, the outcome of the vaccination failure, shingles and immune system disorder were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and immune system disorder to be related to Shingrix and Shingrix.  Additional case details were reported as follows: This case was reported by patient. The age at vaccination was not reported. The age group was not reported, however it was captured as adult as per vaccine indication. In 2018, the patient received the 1st and 2nd dose of Shingrix with an interval of 6 months. The patient was not experimenting. The patient was diagnosed with Shingles. The patient asked if this side effect could occur 2 years later. It was reported that as compared with placebo, Shingrix significantly reduced the risk of herpes zoster by 97.2 percent in patients 50 years and older. Compared with placebo, Shingrix significantly reduced the risk of developing herpes zoster by 91.3 percent in patients 70 years and older. The patient tried to figure out why he or she had developed shingles despite being vaccinated.  The patient had recently started Xolair injections for anaphylaxis and wondered if the drug could suppress immune system enough to cause an outbreak of herpes zoster. In the package insert under drug interactions it was stated that immunosuppressive therapies might reduce the effectiveness of Shingrix. It was unknown if the reporter considered the vaccination failure, shingles and immune system disorder to be related to Xolair. This case was considered as suspected vaccination failure as lab tests confirming varicella zoster virus infection was unknown at the time of reporting.
Information has been received from a physician concerning a 7 month old female with no pertinent medical history and no drug reactions or allergies, who on 24-JAN-2008 was vaccinated intramuscularly with PEDVAXHIB, (Lot # 657386/0820U).  There was no concomitant medication.  The patient experienced a local induration at the site of injection.  The area was not red, not warm and not inflamed.  It was confirmed by the physician PEDVAXHIB was accidentally given after the recall.  The physician already filed a report with VAERS.  No further information was available.  This is case 2 of 2.  Additional information has been requested.
Immediately post vax, pt developed an injection site reaction characterized by a 4 " area of redness and warmth.
Extreme joint pain, lethargy, fever 103.0, nausea/vomiting
Patient received a Pfizer Pediatric dose for his Second Dose as he needed to receive a Pfizer 12+.
A week after getting my vaccine, I woke up with a red spot around the site of the shot. It is warm, slightly swollen and sore. It is a few inches long/wide. The only side effects I had after the shot was a sore arm for 2 days, until last night/today (1 week later).
This person was mistakenly given a dose of Moderna. He is only 17 years old. Although we had several screeners to review the information provided, this still ended up slipping through the cracks.
Horrible reaction to the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Horrible reaction to the vaccine) 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, the patient experienced VACCINATION COMPLICATION (Horrible reaction to the vaccine). At the time of the report, VACCINATION COMPLICATION (Horrible reaction to the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant and treatment information were not provided.
ADMINISTRATION OF VACCINE FROM AFFECTED VIALS DUE TO TEMPERATURE EXCURSION; INCORRECT PRODUCT STORAGE; This spontaneous report received from a pharmacist concerned a 37 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: 1808986, expiry: 02-OCT-2021) dose was not reported, administered on 24-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 24-MAY-2021, the patient experienced administration of vaccine from affected vials due to temperature excursion. On 24-MAY-2021, the patient experienced incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administration of vaccine from affected vials due to temperature excursion and incorrect product storage was not reported. This report was non-serious. This case, from the same reporter is linked to 20210915661, 20210916910, 20210915719, 20210916300, 20210916697, 20210916959, 20210917160, 20210916965, 20210915646, 20210916808, 20210915623, 20210917163, 20210916907, 20210916553, 20210913164, 20210916520, 20210915731, 20210915748, 20210915852, 20210916129, 20210916228, 20210916312, 20210916401, 20210916415, 20210916455, 20210916465, 20210916498, 20210916584, 20210916658, 20210916715, 20210916811, 20210916849, 20210917074, 20210917226, 20210917500, 20210917515, 20210917603 and 20210918425.
A booster dose was mistakenly given instead of a second dose (full volume). The mistake was recognized. The patient was willing to receive a second dose of 0.25ml in the opposite arm, completing his full volume dose.
approx 6PM 24MAR98 2hr p/vax pt lips were swollen & itching;25MAR98 gen hives noted in AM;no resp distress;no visit to PMD;DPH given on recommendation of ask a nurse;28MAR98 hives almost gone;
Approximately 60 to 90 seconds after administering vaccine to patient, the patient experienced a vasovagal syncope episode.  The patient briefly lost consciousness.  The pharmacist was able to catch the patient as he lost consciousness and prevent him from falling and further injuring himself.  The patient was then moved to a mat on the floor to rest and recover.  The patient regained consciousness as he was being moved to a mat on the floor.  The patient then maintained consciousness and recovered fully from the event after approximately 20 minutes.  The patient was monitored for 30 minutes prior to leaving the pharmacy.  He also had a family member (his father) who accompanied him to the appointment and was the patient's driver to and from the pharmacy for his vaccination.
Patient woke up this morning (7-13-09) w/small lesions (rash) approximately 12 lesions between breasts, slightly oozing 0, size.
This non-serious medically confirmed report (initial receipt 09-Oct-2013) concerns a patient in the 80's. On the 27-Sep-2013, the patient received AFLURIA (batch number not reported). On the 09-Oct-2013, the patient received a 2nd dose of AFLURIA. No adverse effects were reported. Outcome was not reported.
Patient Received Moderna Booster (80777-0273-10) Patient received half dose of the adult booster.
Pediatric patient received adult dose; Pediatric patient received adult dose; This case was reported by a nurse via call center representative and described the occurrence of accidental overdose in a 5-year-old male patient who received HBV (Engerix B adult) (batch number NT9X3, expiry date 9th September 2024) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 7th December 2022, the patient received the 1st dose of Engerix B adult and Engerix B Pre-Filled Syringe Device. On 7th December 2022, unknown after receiving Engerix B adult and Engerix B Pre-Filled Syringe Device, the patient experienced accidental overdose and adult product administered to child. On an unknown date, the outcome of the accidental overdose and adult product administered to child were unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 07-DEC-2022 Reporter's Comments: Registered nurse called in to report that a pediatric patient was wrongfully administered the adult dose of Engerix-B on 7th December 2022.  The event took place at the site from where the report was made.  Patients information was also disclosed. The reporter consented to follow up.  The Vaccine Administration Facility was the same as Primary Reporter. Additional Supportive Information: the pediatric patient was wrongfully administered the adult dose of Engerix-B, which led to accidental overdose and Adult product administered to child.
Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Nov-2021 at 1:37 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 16-Nov-2021 at 1:37 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). At the time of the report, PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was provided by the reporter.  No treatment medications was provided by the reporter.   Patient received vaccine which was stored in an ultra cold freezer at minus 82 degrees Farenheight. No vaccine state changes were noticed. The vaccine was never refrozen. None of the vials were punctured. No Previous temperature excursions was reported.   This case was linked to MOD-2021-402935 (Patient Link).
pain in the right maxillary sinus, and upper right molars; pain in the right maxillary sinus, and upper right molars; right fronto-parietal scalp tenderness; numbness of right canines; possible sinus infection; headache; This is a spontaneous report from a contactable physician (patient).  A 56-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EK5730) , intramuscular into the left arm on 17Dec2020,at 17:00 as first single dose for covid-19 immunization.  Medical history included known allergy to dairy from an unknown date.  There were no concomitant medications.  The patient experienced pain in the right maxillary sinus, and upper right molars on 20Dec2020, at 06:00 with outcome of recovering; right fronto-parietal scalp tenderness on 20Dec2020, at 06:00 with outcome of recovering; numbness of right canines on 20Dec2020, at 06:00  with outcome of recovering; possible sinus infection on 20Dec2020, at 06:00  with outcome of recovering; headache on 20Dec2020, at 06:00  with outcome of recovering. Details were as follows: described as possible trigeminal neuralgia,  awoke on 20Dec2020, and noted right eye appeared smaller than the left. Also noted, was pain in the right maxillary sinus, and upper right molars. The patient was afebrile. On 21Dec2020, noted onset of right fronto-parietal scalp tenderness along with numbness of right canines. Patient did not have any skin lesions. Therapeutic measures were taken as a result of the events;  began azithromycin and sinus rinse for a possible sinus. Despite treatment, right scalp pain/tenderness, tooth pain numbness of canines persisted and peaked on 26Dec2020. Symptoms subsided but were still present. Acetylsalicylic acid (ASPIRIN) for headache infection was given with improvement. Symptoms appear to be in the right trigeminal dermatome. Patient had never had chicken pox and had been vaccinated. For varicella,  the patient did not have a rash in the affected dermatome; valacyclovir (MANUFACTURER UNKNOWN), has been started. The events were reported as non-serious. The patient was recovering from the events.
Patient reported having some swelling and redness with warmth after receiving first Shingrix shot. Patient said it resolved fairly quickly and didn't report it at the time because it resolved.
Chills, confusion, HA, abdominal pain, nausea, body aches
Fever >105.0F in am 7/6/01 (within 24 hrs of vaccine, fussy, but consolable.
(L) area swelling & induration noticed on 8/17/11. Fever 101.4. Myalgia.
head ache and body aches starting 5 hours after vaccine progressively getting worse. 12 hours after vaccine fever, chills, worsening body aches and lower back pain. Fever lasted 6 hours. Body aches and lower back pain lasting over 48 hours.
2 days s/p second Pfizer vaccine (6/7 and 6/28) patient presented to ED with pleuritic chest pain and difficulty breathing. Diagnosis myo / pericarditis. Transferred to MC  start treatment with colchicine, lisinopril, metoprolol,
Subsequent to receiving the third dose of hepatitis a virus vaccine, pt experienced enlarged spleen. Additional information has been requested.
Mother noted small erythema (R) upper deltoid 24 hours from administration.  Progressed with warmth slight swelling to 21 cm redness the next 2 days, then subsided. Next office visit: 10/13/20 very minimal redness: 0 swelling or tenderness