chrisvoncsefalvay/vaers-outcomes huggingface dataset:
DEATH; BLOOD CLOTS; ILLNESS; SHORTNESS OF BREATH; SWELLING; This spontaneous report received from a consumer via a company representative concerned multiple patients. The patient's weight, height, and medical histories were not reported. The multiple patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. The batch numbers were not reported and have been requested. No concomitant medications were reported.  On an unspecified date, multiple patients suffered blood clots, shortness of breath, and swelling and were sent immediately to an outside hospital for diagnosis and adequate treatment regardless of conviction and/or confinement. It was reported that, all other inmates who received the Johnson and Johnson vaccination and suffered blood clots, shortness of breath and/or swelling were sent immediately to an outside hospital for diagnosis and adequate treatment regardless of conviction and/or confinement, the plaintiff however was out right refused by these defendants out of personal dislike and retaliation soley. And also stated that Johnson and Johnson was fully aware of these illnesses, potential for and death due to the (Janssen) one shot COVID-19 vaccination and death and illness as the vaccination administration was temporarily discontinued the same day plaintiff received it, due to another inmates death the same day and moments after him. On an unspecified date, the patients (another inmates) died from unknown cause of death. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcomes for the multiple patients with blood clots, illness, shortness of breath and swelling was not reported. This report was serious (Death, and Other Medically Important Condition). This case, from the same reporter is linked to 20230122068.; Sender's Comments: V0- 20230122135- Death, Blood clots- Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
1 day p/vax pt devel a fever of 100.4 & an inj site rxn characterized by a 6cm area of redness, swelling, induration & tenderness;tx w/hismanal & recovered;
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Sep2022 as dose 4 (booster), single (Lot number: GH9693) at the age of 31 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Migraines without auras" (unspecified if ongoing); "BRCA2 mutation carrier" (unspecified if ongoing). Concomitant medication(s) included: TOPAMAX, start date: Jul2021. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 05Aug2023, outcome "recovered" (15Aug2023) and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (07Aug2023) Positive, notes: initially turned positive on 07Aug2023; (15Aug2023) Negative, notes: negative on day 10 (15Aug). Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 07Aug2023 to 11Aug2023. Clinical course: The patient initially turned positive on 07Aug2023 (symptoms day 05Aug). She started paxlovid the same day that she turned positive and completed the 5 day course on 11Aug. She tested negative on day 10 (15Aug) and also had had improvement in symptoms.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300279888 same reporter/patient, different product/AE;
Tachycardia 110-130 while resting. intermittent lightheadedness on standing. bone pain in hips and lower back
seizure occurred - took my husband to emergency room.  He was tested and kept overnight.  Seizure was diagnosed.
Headache; Fever; This case was reported by a consumer and described the occurrence of headache in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th July 2019 15:00, the patient received the 1st dose of Shingrix. In July 2019, several hours after receiving Shingrix, the patient experienced headache and fever. On an unknown date, the outcome of the headache and fever were unknown.   It was unknown if the reporter considered the headache and fever to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. On the day of reporting in the morning, the patient had headache and fever. The patient enquired whether he/she should take something or let it to run the course. Also how long he/she should expect this to last. The patient enquired about to take second round.
Rash all over the body the same evening of vaccination. Manged with diphenhydramine.
rash on his face and back; rash on his back; he also has a fever of 100.9 degrees Fahrenheit; This spontaneous report was received from a patient's grandmother and refers to a 12-month-old male child. He was born prematurely and was allergic to whole peaches. The patient had no concomitant medications or pertinent medical history.  On 19-MAY-2020, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) (dose, route of administration, lot number and expiration date were not provided) for prophylaxis (also reported as "12 month well-visit".   On 27-MAY-2020 around 12 pm, 9 days after the vaccination, the patient's mother noticed a rash on his face and back. The patient had also fever of 100.9 Fahrenheit degrees. There was no treatment given for the events. The patient did not seek medical attention. No laboratory diagnostics or studies were performed. The outcome of the events was reported as not recovered.        The causality assessment between the events and varicella virus vaccine live (oka/merck)(VARIVAX) was not provided.
vertigo; nausea; vomiting; drug exposure during pregnancy; Live birth; dizziness; This is a retrospective pregnancy case. This 31-year-old female subject was enrolled in an open label study. The subject received Boostrix on 17th July 2017, for prophylaxis. The subject received Boostrix at an unknown time during the pregnancy.   On 17th July 2017, less than a day after receiving Boostrix, the subject developed vomiting. Serious criteria included hospitalization. Additional event(s) included dizziness on 17th July 2017, live birth, vertigo with serious criteria of hospitalization, nausea with serious criteria of hospitalization and vaccine exposure during pregnancy. The subject was treated with intravenous fluid (nos) (Intravenous Fluid). The outcome of vomiting was unknown. The outcome(s) of the additional event(s) included vertigo (unknown), nausea (unknown), dizziness (unknown), live birth (unknown) and vaccine exposure during pregnancy (unknown). The pregnancy resulted in a live neonate with no apparent congenital anomaly. After [weeks gestation], the subject gave birth to a [gender] neonate via unknown delivery.   It was unknown if the investigator considered the vomiting, dizziness, vertigo and nausea to be related to Boostrix.   Additional details were provided as follows: The patient received Boostrix vaccine with batch number 594SR and expiry date 8th August 2019, while she was pregnant.  Later that day the patient came back to the office complaining about vomiting and dizziness.  The patient received intravenous fluid and went home.  The patient then came back and was hospitalized for vertigo, nausea and vomiting.  She stayed in the hospital for several days.  The patient delivered a healthy baby. The patient was pregnant again and was debating whether she should get the Boostrix vaccine or not.  The reporter consented to follow up.
missing first vaccine date \ a wrong second vaccination date; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (missing first vaccine date \ a wrong second vaccination date) in a 53-year-old male patient 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (missing first vaccine date \ a wrong second vaccination date). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (missing first vaccine date \ a wrong second vaccination date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was reported that the correct information on the patient's vaccine card, regarding a missing first vaccine date and a wrong second vaccination date in the data at the clinic. Patient took part in a COVE study program, in which he may or may not have received his study vaccination at clinic, as the second dose records were put in wrong, then erased, and are no longer available there. Concomitant medications were not provided. Treatment information was not reported.
This 64 year old female experienced an adverse event. At baseline, she presented in a wheelchair. Within 5 minutes after vaccination, she complained of a racing heart, a new onset tremor of hands and head, and slurred/stuttering speech.  She denied chest pain, shortness of breath or itching.  No facial droop or one-sided weakness was observed.  The patient had a history of hypertension and history of an adverse reaction to albuterol in November 2020.   The patient described being nervous to get the vaccine due to her previous reaction to alberterol which had the similar effects as today's.    The patient's new tremor worsened, and speech became more slurred and stuttered while we observed her.  The patient denied any pain and described a similar event that caused her to be hospitalized for a week with no definitive diagnosis.  Her primary care doctor had cleared her to get the vaccine.    Her Vitals were as follows: BP 160/90. HR 65, RR 20. Heart sounds were regular with occasional PVC's. Lung sounds were clear No visible rash on neck, trunk or injection site. Capillary refill was normal.  Mild edema in both lower extremities. No swelling of the lips. No visible droop in facial muscles. Patient was tearful and struggled to speak.  She repeatedly said she was tired.  She reported nausea.  EMT was called and found similar vitals and O2 saturation at 100% on room air by pulse ox.  O2 via nasal canula was begun.  Rhythm strip showed NSR.  Patient refused transport to the hospital for further evaluation.  She was informed of a possible Transient Ischemic Attack (TIA) could be occurring which could need a blood thinner and further work up.    Patient was tearful saying her previous hospitalization was traumatic and did not want to return.  EMS offered her transport to another hospital facility via private vehicle, and she refused.  We offered to contact her primary care doctor and she also refused.  She was concerned about the cost of a hospital stay if she signed out AMA.  EMS left the facility and offered to return if the patient changed her mind.  The patient's symptoms had not resolved by 4:30pm.  The patient's son, by phone, confirmed she would be monitored until 5pm.   She was driven home by one of our staffers. The next day, the patient told our staffer that she felt well. She said it took about 7 hours for her speech to return. She said her head, stomach and body felt better in the morning. She said she going to see an allergist as her doctor recommended.   Our presumed diagnosis was a TIA related to uncontrolled HTN with anxiety.
PFIZER COVID UPDATE IN APRIL STATED THE NEW EXPIRATION DATE IS 12 MONTHS FROM THE MANUFACTURE DATE. OUR BOX WAS MARKED EXPIRATION DATE OF 10/31/22 BUT ACTUALLY SHOULD HAVE BEEN 9/30/22. DOSE WAS GIVEN ON 10/8/22.
No additional AE reported; Nurse reported two temperature excursions on multiple refrigerated vaccines.  There was a prior excursion on 5/3/2022 and a recent excursion on 5/26/2022.  She said it was very likely all vaccines had been administered since the excursions occurred.; This spontaneous report has been received from a nurse, concerning a 06-months-old male patient. No information was provided regarding the patient's pertinent medical history, concomitant medications, concurrent conditions, and previous drug reactions or allergies.  On 03-MAY-2022, the rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot #U026664 experienced a temperature excursion of 47.3 Fahrenheit degrees (F) for 5 minutes, if a digital data logger was involved was not reported (product storage error).   Consequently, on 16-MAY-2022, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot number reported as U026664 confirmed as valid, expiration date reported and stablished as 24-FEB-2023) administered orally as prophylaxis (formulation, strength, dose, vaccination scheme were not provided) (product storage error). No additional adverse events (AE) reported (no adverse event).   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2206USA001582: US-009507513-2206USA001583: US-009507513-2206USA001584: US-009507513-2206USA001585: US-009507513-2206USA001586: US-009507513-2206USA001587: US-009507513-2206USA001588: US-009507513-2206USA001589: US-009507513-2206USA001590: US-009507513-2206USA001591: US-009507513-2206USA001592: US-009507513-2206USA001593: US-009507513-2206USA001594: US-009507513-2206USA001595: US-009507513-2206USA001596: US-009507513-2206USA001597: US-009507513-2206USA001598: US-009507513-2206USA001599: US-009507513-2206USA001600: US-009507513-2204USA001865: US-009507513-2204USA001998: US-009507513-2204USA002052: US-009507513-2204USA001952: US-009507513-2206USA001103:
minor pain discomfort directly across the chest below breast/band of minor pain; minor pain discomfort directly across the chest below breast/2 inches high/discomfort after the last 3 doses; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (minor pain discomfort directly across the chest below breast/band of minor pain) and CHEST DISCOMFORT (minor pain discomfort directly across the chest below breast/2 inches high/discomfort after the last 3 doses) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 088D21A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy, Adhesive tape allergy, Benign prostatic hyperplasia and Blood pressure high. Concomitant products included TAMSULOSIN for Benign prostatic hyperplasia, VALSARTAN for Blood pressure high, VITAMINS NOS (DAILY VITAMINS), L-CITRULLINE, CUCURBITA PEPO SEED, SERENOA REPENS FRUIT, SITOSTEROL, ZINC OXIDE (PROSTATE PLUS), CURCUMA LONGA (TURMERIC [CURCUMA LONGA]), PYCNOGENOL, CORDYCEPS SINENSIS (CORDYCEPS), VITAMIN B3 and L-ARGININE [ARGININE] for an unknown indication.    On 25-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In October 2021, the patient experienced CHEST PAIN (minor pain discomfort directly across the chest below breast/band of minor pain) and CHEST DISCOMFORT (minor pain discomfort directly across the chest below breast/2 inches high/discomfort after the last 3 doses). At the time of the report, CHEST PAIN (minor pain discomfort directly across the chest below breast/band of minor pain) and CHEST DISCOMFORT (minor pain discomfort directly across the chest below breast/2 inches high/discomfort after the last 3 doses) had not resolved.            patient reported, got symptoms about 2 days after the shot. Patient felt 2 inches high discomfort straight across his chest and was more prominent on the right side. Pain was away from the side of heart, continued on a straight line across the chest and went directly under the heart side. Patient felt discomfort once in a while throughout the day but mostly felt it when he was cooking dinner. Patient told it took a day for an episode to start after vaccination and he could not remember how long they lasted for but patient was still experiencing. Patient had not gone to the doctor for labs or tests about myocarditis/pericarditis.  No treatment medication was reported by reporter.   This case was linked to MOD-2022-569116, MOD-2022-569123 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 17-May-2022: Patient details, Reporter updated, Start date of vaccine, Medical History, Concomitant medications updated.
It was reported in a published article that a female patient, who was required to received a measles vaccine for college, was vaccinated on 11/8/90 with a dose of measles virus vaccine live (lot # not reported). It was reported that the patient was 17 days pregnant when she was vaccinated. It was reported that the mother was certain that she was not exposed to alcohol, drugs or other teratogens during her pregnancy. She delivered a boy on 7/2/91 who weighed 6lbs 3ozs and who was noted to have several visible congenital anomalies at birth, namely micrognathia, a cleft palate, hypospadias and cryptorchidism. The baby was rushed to a tertiary hospital where he was found to have an abnormal EEG and where a MRI revealed both cerebral dysgenesis and agensis of the corpus callosum. He developed clinical seizures at the age of 6 months and was discovered to be partially deaf and visually impaired. He was diagnosed with autism before he received his MMR (second generation) vaccine. It was reported that the family's history was negative for autism, and all genetic studies had been negative as well. The mother's second son, a boy born in May 1998 was normal and it was reported this child had not received the MMR (second generation) vaccine. The author stated that in spite of its limitation, this study suggests that an autism/vaccine connection may exist. Upon internal review, clinical seizures, partially deaf, visually impaired and autism were determined to be other important medical events (OMIC). No further information is available. A copy of the published literature article is attached as further documentation of the patient's experience.
I woke with a lump under left arm, diarrhea and vomiting. I had shortness breath and pain in my chest. I went to the hospital because I could not breath. I am still experiencing breathing problems and I cannot swallow. I lost 25 pounds in 3-weeks. I have hives all around my neck.
A headache started morning after shot. Then started chills and fever up to 102.5 and major aches about 2-3 in the afternoon. The lymph nodes in my armpits became swollen (prior to noticed fever) and the left side was so bad that I couldn't lay on that side of my body for a week. The fever, headache, and aches lasted about 24 hours. The headache was so bad that i struggled breathing and walking. After a week of swollen lymph nodes, i had a breakout of a dormant virus for a week herpes). After healing from this i got laryngitis with no other symptoms besides swollen lymph nodes. I believe that all these swollen nodes are from handling this booster shot and I've been miserable. I hope it stops.
Pt recvd 3 doses of Engerix-B vax & 29OCT91 found to be a non-seroconverter;
Skin Lesion, Fever, Pruritus - Information has been received from a registered nurse concerning a 6 year old Caucasian female patient who on 13 Aug 1996 was vaccinated sc in the left arm with a first dose of varicella virus vaccine live (lot 617077/02490).  There were no concomitant modications, past medical history of illneses at the time of vaccination.  On 04 May 2000 the patient developed approximately 40 scattered papular lesions, pruritus and a low grade fever. Follow up information from a regisitered nurse reported that on an uspecificed date the patient recovered.
difficulty breathing; low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (difficulty breathing) and PYREXIA (low grade fever) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022C21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy NOS (Allergies were ongoing and have been really bad for the last two weeks. Allergies were not worse since receiving the vaccine.).    On 17-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (difficulty breathing) and PYREXIA (low grade fever). At the time of the report, DYSPNOEA (difficulty breathing) and PYREXIA (low grade fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 01-Jul-2021: Significant FU: Outcome of events reported.
Bleeding started really heavy/ Soaking up a bunch of different pads; Really bad pain in stomach as well as right pelvic area; Really bad pain in stomach as well as right pelvic area; Pain in right chest area; bunch of pain; Headache; Diarrhea; Nausea; Pain where I got the shot; This is a spontaneous report from a contactable consumer (patient). A 33-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6200) via an unspecified route of administration in the left arm on 28Feb2021 at a single dose for COVID-19 immunization. The patient medical history was not reported. The patient mentioned that the only medication she was taking was birth control. The patient got the COVID-19 vaccine on Sunday and had the normal side effects like headache, diarrhea, nausea and pain where she got the shot. The patient took Excedrin extra strength on Sunday night. Then on Monday night (01Mar2021) when she went to sleep there was pain in her chest, her right chest area there was in a bunch of pain. When the patient woke up on Tuesday morning (02Mar2021), she had bleeding, and that bleeding started really, really heavy. She just came off of her period a week ago. She had a full blown period for an entire week and then on Tuesday the patient started bleeding very, very heavily. She was soaking up a bunch of different pads. She was not sure what it was, she had pain, really bad pain in stomach as well as like pain in her pelvic area, right pelvic area.  Patient weight was 135 (units unknown). The outcome of the events was unknown.
Pt was given DTaP 4 and IPV 3, Hib. pt developed hives all over in about 8-10 minutes. swelling of knee joints.
Patient had syncopal fainting and profuse sweating, no difficulty breathing.  Ambulance called, assessed patient, transported from pharmacy after about 10 minutes.  Patient remained sweating, light headed while still in pharmacy