chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a pharmacist and a 58 year old female patient reporting on herself who was allergic to codeine and cough syrup and with no pertinent medical history. On 28-MAR-2015 the patient was vaccinated with a dose of ZOSTAVAX vial (dose, route, anatomical location, lot number and expiration date not reported). On the night of the same day, she did not feel well (Malaise) and was irritable. On 29-MAR-2015 the injection site had a red, pus filled blister the size of 4 inches by 2.5 inches and patient still did not feel well. By the evening of that day, her right hand and thumb had developed blisters and as of 30-MAR-2015 she had developed more blisters on her right hand and the fingertips on her right hand were very red so she visited her physician, who prescribed Acyclovir. The patient was not recovered from the events at the time of the report, Additional information has been requested.
Pacing; Talking gibberish; Temperature; highest 101 degrees; Being crazy; never acted like that before/Acting very different; Aggressive, pulling his hair; Body aches; Bad headache; Frequently waking up; Could never get comfortable; Very sick for 2 days; This is a spontaneous report from a contactable consumer (parent). A 13-years-old male (son) patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: FC3182, patient was 13-year-old at the time of vaccination), via an unspecified route of administration, administered in Arm Left on 22Aug2021 at 10:30 as DOSE 2, SINGLE for covid-19 immunisation. Medical history reported as no. There were no concomitant medications. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: FA7485, patient was 13-year-old at the time of vaccination), via an unspecified route of administration, administered in Arm Left on 02Aug2021 as DOSE 1, SINGLE for covid-19 immunisation. Reported that patient wake up and have the behaviors, then sleep for about 30 minutes or so, wake up and do it again for about 15 minutes. He could never get comfortable. States this only occurred for that night. Caller states the fever, body aches, and bad headache her son experienced lasted for about 2 days. No additional Vaccines Administered on Same Date of the Pfizer Suspect, no prior Vaccinations within 4 weeks, no AE(s) following prior vaccinations. On 22Aug2021, the patient experienced pacing, talking gibberish, temperature; highest 101 degrees, being crazy; never acted like that before/acting very different, aggressive, pulling his hair, body aches, bad headache, frequently waking up, could never get comfortable, very sick for 2 days. AE(s) does not require to visit emergency Room or physician Office. The patient underwent lab tests and procedures which included body temperature: 101 degrees on 22Aug2021. The outcomes of events (Temperature; highest 101 degrees, Body aches, Bad headache, very sick for 2 days) were recovered on an unspecified date in 2021 and the outcomes of events (Pacing, Talking gibberish, Being crazy; never acted like that before/Acting very different, Aggressive, pulling his hair, Frequently waking up, Could never get comfortable) were recovered on 23Aug2021.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
16OCT95 discomfort lt antecubital space followed by soreness lt foreman & edema lt wrist &  hand;30OCT95 subsequent resolution of discomfort but cont edema wrist & hand, gradually improving but unresolved as of 11JAN96;no lymphadenopathy
Massive external Hemorrhoids three times in four months and NEVER had them before getting this vaccine and I am almost 60 years old with no family history of this.  Medications are unchanged for 12 mo; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59 year-old male patient received bnt162b2 (BNT162B2) (Lot number: EW0102) at the age of 59 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Ventricular Tachycardia (I have an ICD)" (unspecified if ongoing), notes: Ventricular Tachycardia (I have an ICD). Concomitant medication(s) included: LEVOTHYROXINE SODIUM; BISOPROLOL. Past drug history included: Keflex, reaction(s): "Known Allergies", notes: Allergies: Keflex. Vaccination history included: Bnt162b2 (product=COVID 19, brand=Pfizer,, lot number=EW0170,, lot unknown=False,, administration date=22Apr2021,, administration time=02:00 PM,, dose number=1,, vaccine location=Left arm), administration date: 22Apr2021, when the patient was 59 years old, for Covid-19 immunization. The following information was reported: HAEMORRHOIDS (non-serious) with onset 04Jun2021, outcome "not recovered", described as "Massive external Hemorrhoids three times in four months and NEVER had them before getting this vaccine and I am almost 60 years old with no family history of this.  Medications are unchanged for 12 mo". Therapeutic measures were not taken as a result of haemorrhoids.  Additional Information: Facility type vaccine: Pharmacy or Drug Store. Adverse event: Massive external Hemorrhoids three times in four months and NEVER had them before getting this vaccine and he was almost 60 years old with no family history of this. Medications are unchanged for 12 months with no side affects. Only thing that changed since April was getting two doses three weeks apart of the Pfizer vaccine.  No follow-up attempts are possible. No further information is expected.
The spontaneous report was received from the physician via company representative refers to three young patients of unknown age and gender. Information about patients medical history, concurrent conditions and concomitants medications were not reported. On an unknown date, the patients were vaccinated with a dose of ROTATEQ (dosing details not provided). Subsequently, on an unknown date, the patients experienced bloody stools. The patients sought medical attention by visiting the physician on an unknown date. The outcome of the event was unknown. Causality assessment was not provided. No product quality (PQC) involved. No other information provided. Upon internal review, the event of haematochezia was determined to be medically significant. Additional information is not expected as the reporter did not wish to be contacted.
Since receiving the second dose of Moderna COVID-19 vaccine on September 24, 2021, my menstrual cycle has been non-existent. I have had only 4 brief days of light spotting on January 16 - 19, 2022. My menstrual cycle was normal in the beginning of September 2021 (Sept. 7 - Sept 14). I noticed on October 6, 2021 that my menstrual cycle was late and at-home urine pregnancy tests were negative. From that point until the 4 days in January 2022, I had not had a cycle nor spotting. To this day I have not had a menstrual cycle.  I saw my OB-GYN APRN ( APRN) on Tuesday, June 14, 2022 and reported my adverse effects and concerns. She decided to discontinue my metformin and prescribed norethindrone 0.35mg to hopefully promote menstruation.
tested positive for COVID; tested positive for COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group.  A 40-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Apr2021 as dose 1, single (Lot number: ER8734), on 28Apr2021 as dose 2, single (Lot number: EW0171) and on 22Nov2021 as dose 3 (booster), single (Lot number: FH8028) at the age of 40 years, all intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 15May2022 at 10:00, outcome "recovering" and all described as "tested positive for COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (15May2022) Positive. Therapeutic measures were not taken as a result of vaccination failure, covid-19.  Follow-up attempts are completed. No further information is expected.
made me sick; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were reported as follows: The age at vaccination was not reported. The patient stated that it made him or her sick.
Reddened area of arm around injection site (4 x 4 inches in diameter), mildly tender to palpation, patient seen on 9/25/14, Benadryl spray applied, and asked to take Benadryl at home.
Starting approximately 18 hours after the injection onset of low-grade fever (99-100s), malaise, dizziness, and generalized intense joint pain. For 72 hours after the injection a localized erythema, swelling, and pain at the injection site.
Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 29-MAR-2022.; Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 29-MAR-2022.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 29-MAR-2022.) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 29-MAR-2022.) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Mar-2022 at 8:04 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 29-Mar-2022 at 8:04 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 29-MAR-2022.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 29-MAR-2022.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 29-MAR-2022.) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 29-MAR-2022.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The ethnicity of the patient was reported.  No Concomitant product use was reported.  The patient received vaccine past its 30 day expiry date The vaccine went into 2-8 degree Celsius thaw state on or about 24-Dec-2021. The vaccine was administered up until it manufactured expiry date of 04-Apr-2022. The patient received booster dose.  No treatment information was provided.
vaccine expired 8/31/22 from manufacturer. administered 9/5/22.   contacted pfizer and lot good through 12/21/22
Blood Pressure elevated the next day after vaccine.   Normally around 134/83 and it was 145/92 for nearly 2 days. No other reason known. Additionally, on 3/20 I felt nauseous, fatigue, minor headache and general malaise. (BP went back to normal)
headache; Pain on her back; felt very hot and cold at the same time; her body was shaking because of how cold she felt; 100°F fever; lot of pain on the arm of the injection; A spontaneous report was received from a (Reporter like HCP,) concerning a 39  Years-old  female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events pain in her back , felt very hot and cold at the same time, Her body was shaking because of how cold she felt,  100 F fever, a lot of pain on the arm of the injection,  100.2 F  fever, she did not feel good to go to work, headache.  The  patient's medical history include covid-19 positive in the month of may 2020   No relevant concomitant medications were reported.    On 26 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 039K20A) intramuscularly for prophylaxis of COVID-19 infection.  On 26 Jan 2021 after 3 hours after vaccination during her working hours in office the patient started to experience pain on the arm of injection,And that night after 10.30pm she felt very hot and cold at the same time and her body was shaking  because of how cold she felt, she had a 100°F fever. She also felt a lot of pain on her arm and on her back, on 27 Jan 2021  morning she had a 100.2°F fever,She did not feel  good to go to work, the symptoms went  away but she has a headache.   Treatment details if provided  include Tylenol for fever  Action taken with mRNA-1273 in response to the events was not reported.   On date, the outcome of the event(s) pain in her back , felt very hot and cold at the same time, Her body was shaking because of how cold she felt,  100 F fever, a lot of pain on the arm of the injection,  100.2 F  fever, she did not feel good to go to work, headache. were  considered Resolved on 27 Jan 2021   She made a comment that at work many people received the vaccine and only felt pain on their arms. Except for those that had had COVID-19, like herself, they had more side effects after receiving the vaccine.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
Really high fever.; A spontaneous report was received on 12 Mar 2021, from a consumer concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced really high fever,  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 10 Mar 2021, prior to the onset of the event the patient received first of two planned doses of mRNA-1273 (lot/batch: unknown) via unknown route for prophylaxis of COVID-19 infection.  On 11 Mar 2021, the patient experienced the event really high fever.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of event really high fever,  was unknown.
shingles; This spontaneous report was received from a female consumer of unknown age referring to herself. The patient's relevant medical history, drug reactions/allergies and concomitant medication were not reported.  In 2008, the patient was vaccinated with zoster vaccine live (ZOSTAVAX), 0.65 mL, subcutaneously, for herpes zoster prophylaxis (lot number and expiration date were not reported).         The patient wanted to get vaccinated with zoster vaccine (SHINGRIX), but there was a wait and it took 3, almost 4 months to get it and meanwhile the patient experienced shingles, some date less than 4 months after December 2018 (approximated to 2019).  The patient was not upset about that because zoster vaccine live (ZOSTAVAX) worked for 10 years, just like it was supposed to, and she learned a lot by having the shingles and how to take care of her body better. No additional adverse events or product quality complaints were reported.  The outcome of herpes zoster was reported as recovered on unspecified date. Causality assessment was not provided.
12/16/2020 episode of abdominal cramps I had a BM episode of loose stools and soon after that within seconds I started profusely sweating on my forehead and felt lightheaded and very weak, My wife noticed how much i was sweating my body was cool and clammy, episode lasted at least 5 mins if not more so I just laid down until I started feeling better. Once symptoms subsided I took 1000 mg of tylenol, Heavy head throughout the day.
Information has been received from a registered Nurse (R.N.) concerning her 12 weeks old daughter, who approximately on 24-JAN-2011, was vaccinated SC with a 0.5ml dose of VARIVAX (Merck) (lot# not reported). No adverse effects reported. Additional information has been requested.
My grandpa almost died from that vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NEAR DEATH EXPERIENCE (medically significant, life threatening), outcome "unknown", described as "My grandpa almost died from that vaccine".  Clinical information: During an open-ended question, reporter stated that my grandpa almost died from that vaccine. Age provided as 22.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient had burning pain in left arm right after receiving Pneumo vaccine her arm swelled up and she began to have pain radiating down her arm. Pain stayed persistent even six months after incident.
Arm pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm pain) 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 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm pain). At the time of the report, PAIN IN EXTREMITY (Arm pain) had resolved.            No concomitant medication was reported. T he treatment information was unknown.
Within 12 hours of receiving the COVID Booster, I had intense GI symptoms that have continued to date. I've lost 20 lbs and yesterday an internal EGD and sono of the pancreas revealed severe scaring and chronic pancreatitis
w/in 48hr described rxn of redness, warmth, edema measuring 7" x 4" & raised approx 1";sought medical care & was advised to take Biaxin & use warm compress;
Gave NOVARTIS H1N1 vaccine 0.5ml. Should have given Sanofi Pasteur H1N1 vaccine 0.5ml. No signs or symptoms distress noted.
STRICTURE OF COLON; DIZZINESS; URINARY INCONTINENCE; BOWEL INCONTINENCE; FALL; DIARRHEA; CONSTIPATION; NAUSEA; VOMITING; COVID-19; This spontaneous report received from a patient via other manufacturer concerned a 68 year old female of unspecified race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe adult Crohn's disease and there was no reported medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported, expiry: unknown) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers.  Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported, expiry: unknown) dose, frequency, and therapy dates were not reported for moderate to severe adult Crohn's disease. No concomitant medications were reported.  On an unspecified date, the patient experienced stricture of colon, dizziness, urinary incontinence, bowel incontinence, and fall. On an unspecified date in JAN-2022, the patient experienced covid-19. On 21-JAN-2022, the patient experienced covid vaccine issue nausea, and vomiting. On an unspecified date in MAR-2022, the patient experienced constipation, and diarrhea.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab was not reported. The outcome of the dizziness, urinary incontinence, bowel incontinence, constipation, stricture of colon, fall, diarrhea, nausea, vomiting and covid-19 was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220916246-covid-19 vaccine ad26.cov2.s-stricture of colon. The event(s) has an unknown/unclear 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: MEDICAL HISTORY. Therefore, this event(s) is considered not related.
Warm sensation throughout body within minutes of injection. Approximately 20 minutes after shot noticed a feeling of nasal congestion/sinus blockage. Approximately two and a half hours after shot low grade fever and mild headache. Approximately 3 1/2 hours after shot a short bout of ringing in left ear that lasted approximately 15 minutes. Approximately 67 hours after shot bouts of mild vertigo. Approximately 74 hours after shot bout of severe vertigo lasting approximately 3 hours and subsided to mild vertigo until the following evening.  3/31 sinuses finally cleared.
fever; chills; tiredness; feels weak; This is a spontaneous report from a contactable consumer via medical information team. A 64-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and expiration date: was not reported), (at the age of 64-Years-old) dose 2 via an unspecified route of administration on 23Aug2021 as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 for covid-19 immunisation. On 23Aug2021, patient experienced chills right away, as soon as the patient received the second dose of Pfizer Covid 19 Vaccine and also felt tired. Later the chills went away. On 24Aug2021, the fever began at midnight or 01:00, very early morning. Clarified he was referring to the early morning of 24Aug2021. The Patient stated it was 40% better. The caller stated the tiredness was little better. On an unknown date in Aug2021, the patient stated he felt weak and slightly kind of warm. Weak like when you go through that it tares up, weak inside. The caller stated he just wanted to know if the symptoms linger and does not want to go through all of this. The patient underwent lab tests and procedures which included body temperature and results was unknown on 24Aug2021. At the time of this report, the outcome of fever, tiredness was recovering, chills recovered on an unknown date in Aug2021 and feels weak was unknown.  No follow-up attempts are possible. No further information expected. Information on batch/lot number cannot be obtained.
Pt. passed out after rec. BOOSTRIX - BP 80/40. No adverse reaction from previous doses. Pt given Pepsi & snack. BP 120/84. P RRR A & O. Girlfriend driving him home.