chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient. A female patient received BNT162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Manufacturer- Unknown, Dose 1), for COVID-19 Immunization; Covid-19 vaccine (Manufacturer- Unknown, Dose 2), for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "booster"; MUSCULAR WEAKNESS (non-serious), outcome "unknown", described as "muscle weakness"; FATIGUE (non-serious), outcome "unknown", described as "fatigue"; MENSTRUAL DISORDER (non-serious), outcome "unknown", described as "Menstrual cycle is also currently 5 days late"; INJECTION SITE PAIN (non-serious), outcome "unknown", described as "Injection site pain". The lot number for bnt162b2 was not provided and will be requested during follow up.
Passed out; blood pressure dropped to 70/50/ big blood pressure drop from 110/90 to 70/50; The initial safety information received was reporting only non-serious adverse drug reaction. Upon receipt of follow-up information on 19Apr2021, this case now contains serious adverse reaction. Information processed together.  This is a spontaneous report from a contactable consumer (patient's father) via Medical Information team. A 31-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 01Apr2021 (Batch/Lot number and Expiration date were not reported) at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was in excellent health and had no known allergies. The patient had took the Pfizer COVID-19 vaccine 18 days prior reporting (on 01Apr2021) and had blood pressure dropped to 70/50 and emergency medical services (EMS) was called an hour with him. The reporter was asking if the patient should take the second dose being that he had this reaction. The reporter further asked for the efficacy of one dose of the Pfizer COVID-19 vaccine and how long was the coverage of the vaccine as far as needing a booster shot. The reporter also asked about the 6 months topline analysis results of the Pfizer-BioNTech COVID-19 vaccine. It was further reported that fifteen minutes after the COVID-19 shot on 01Apr2021, the patient passed out; the patient had a big blood pressure drop from 110/90 to 70/50. The EMS was called in and attended to the patient. The patient was there for about an hour. The reporter was just calling to find out if the patient could get the second shot. The outcome of the events was unknown.  Information on the batch/lot number has been requested.
Information has been received from a consumer concerning a female who on 04-DEC-2007 was vaccinated with a dose of PedvaxHIB. Subsequently, the patient experienced paralysis in her legs. The child was transported to the hospital. At the time of the report the patient's outcome was unknown. Upon internal review, paralysis of the legs was considered to be an other important medical event. Additional information has been requested.
Sore-warm arm-fever at 24 hrs past inj. Admitted to hospital.
numbness in extremities; Onset was slow, but in mid May started to notice numbness / tingling in extremities.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient. A 47-year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 31Mar2021 10:30 (Lot number: EP7533, Expiration Date: 31Jul2021) at the age of 47 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose: 1, Lot number: EN6208, Time: 10:30 AM, Anatomical location: Left arm, Route: Intramuscular Exp. date: 30Jun2021), administration date: 10Mar2021, when the patient was 47 years old, for Covid-19 immunization. The following information was reported: HYPOAESTHESIA (non-serious) with onset 14Jun2021, outcome "not recovered", described as "numbness in extremities"; PARAESTHESIA (non-serious) with onset 17May2021, outcome "not recovered", described as "Onset was slow, but in mid-May started to notice numbness / tingling in extremities.". Therapeutic measures were not taken as a result of hypoaesthesia, paraesthesia.  Additional information The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not take any other medications within 2 weeks of vaccination. Relevant past drug history was none. The patient did not have any Known allergies. Family medical history relevant to AE(s) was no family history related to AE. Relevant tests were None. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Reported Event: Onset was slow, but in mid-May Date of start of reaction/event: 17May2021 started to notice numbness / tingling in extremities. Most noticeably in my fingers and toes at all temperatures. The sensation is ongoing and most recently affected this morning on my walk into the office and while typing this. Most noticeable when using my hands and feet (i.e., typing, walking, standing, etc.). Illness/AE: Numbness in extremities Onset date: 14Jun2021 Stop date: Ongoing, Pertinent details: Numbness/ tingling hands, fingers, toes. The event did not result in Prolonged Hospitalization Comments/Narrative: Physician recommended (withheld) to improve circulation. Filling effects claim on Pfizer site. No follow-up attempts are possible. No further information is expected.
Abrupt loss of consciousness, diaphoresis, increased pulse, possibly lowered blood pressure. Patient's mother reported what she believed to be a very brief seizure. I did not witness the seizure-like event but arrived at scene a few seconds later, after she regained consciousness.
pt recv vax & w/in 24hr post vax pt exp arthritis which became chronic, lasting approx 18months;Md indicated that he was a consultant for anther MD & did not have all of the pt specific info;
SATURDAY MORNING CLIENT C/O R ARM HURTING. MOM SAID ARM SWOLLEN ABOUT THE SIZE OF TENNIS BALL, RED,& HOT. NO FEVER. NO OTHER SYMPTOMS.
C/O- Dizziness and headache, stated did not take my labetalol today, takes BID  Action- Monitored in OBS area, released after 30 minutes with no complaints
third dose had an impact on her hormones; sick with all three doses; had the period start and it is still coming; breasts were terribly sore (one week ago)/breasts hurt so bad/hurt to put on a bra; fever not above a 100°F after dose 3; extremely lethargic after dose 3; Too much sleep after dose 3; This spontaneous case was reported by a consumer and describes the occurrence of MENSTRUAL DISORDER (had the period start and it is still coming), VACCINATION COMPLICATION (third dose had an impact on her hormones), ILLNESS (sick with all three doses), LETHARGY (extremely lethargic after dose 3) and SOMNOLENCE (Too much sleep after dose 3) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 28-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Aug-2021, the patient experienced LETHARGY (extremely lethargic after dose 3), SOMNOLENCE (Too much sleep after dose 3) and PYREXIA (fever not above a 100°F after dose 3). On 22-Sep-2021, the patient experienced BREAST PAIN (breasts were terribly sore (one week ago)/breasts hurt so bad/hurt to put on a bra). On 28-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MENSTRUAL DISORDER (had the period start and it is still coming). On an unknown date, the patient experienced VACCINATION COMPLICATION (third dose had an impact on her hormones) and ILLNESS (sick with all three doses). The patient was treated with IBUPROFEN on 29-Aug-2021 for Adverse event, at an unspecified dose and frequency. On 29-Aug-2021, LETHARGY (extremely lethargic after dose 3), SOMNOLENCE (Too much sleep after dose 3) and PYREXIA (fever not above a 100°F after dose 3) had resolved. At the time of the report, MENSTRUAL DISORDER (had the period start and it is still coming) had not resolved, VACCINATION COMPLICATION (third dose had an impact on her hormones) and ILLNESS (sick with all three doses) outcome was unknown and BREAST PAIN (breasts were terribly sore (one week ago)/breasts hurt so bad/hurt to put on a bra) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Aug-2021, Body temperature: 100 (High) fever not above 100°F.         No relevant concomitant medications were reported. PAPs smear was completely normal.   This case was linked to MOD-2021-335764, MOD-2021-335745 (Patient Link).
Patient was admitted to the hospital on 05/21/2021 with bilateral pulmonary embolism of unclear etiology.   Risk factors for pulmonary embolism included obesity and  tobacco abuse.  No other risk factors for pulmonary embolism.   She received her 1st dose of the phizer COVID-19 vaccination less than 30 days prior to presentation with PE.
Initial report was received from a health care professional on 07 November 2008. A 36-year-old male patient with an unknown medical history, had received an intramuscular left deltoid injection of TYPHIM VI, lot number B0347-2, and a subcutaneous left upper arm injection of YF VAX, lot number UF305AA, and a first dose right deltoid intramuscular injection of Hepatitis A (manufactured by GSK), lot number AHAVB251BA on 23 October 2008 and eight days later, he developed widespread hives and severe pain in his neck and shoulders. The patient was evaluated in the emergency room and prescribed PREDNISONE. Concomitant medications included LAMISIL. The reporter followed-up with the patient (date not specified), at which time, the patient indicated the pain was still present to a lesser degree, however hives were still occurring. The patient's recovery status was reported as unknown at the time of the report. Documents held by sender: none.
My son started in toeing and with an abnormal gate and falling over 2 days after the vaccine. Now he has measles on his face which I know is normal
Had significant pain in deltoid region of arm which was severe enough to prompt return visits to clinic.  Also has shooting "tingles" of pain down the arm and lingering numbness in middle 3 fingers of Lt hand.
still feeling a little groggy but not bad; second dose given a week before his original second dose appointment; he felt like was getting sick; weird feeling; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (he felt like was getting sick), FEELING ABNORMAL (weird feeling), SOMNOLENCE (still feeling a little groggy but not bad) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose given a week before his original second dose appointment) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027B21A and 027B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included BICTEGRAVIR SODIUM, EMTRICITABINE, TENOFOVIR ALAFENAMIDE FUMARATE (BIKTARVY) for an unknown indication.   On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-May-2021, the patient experienced ILLNESS (he felt like was getting sick) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose given a week before his original second dose appointment). 04-May-2021, the patient experienced FEELING ABNORMAL (weird feeling). On 05-May-2021, the patient experienced SOMNOLENCE (still feeling a little groggy but not bad). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, ILLNESS (he felt like was getting sick), FEELING ABNORMAL (weird feeling), SOMNOLENCE (still feeling a little groggy but not bad) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose given a week before his original second dose appointment) outcome was unknown.            Relevant concomitant medications included ADHD medications and HIV medications.     This case was linked to MOD-2021-106709 (Patient Link).
GSK receipt date was 22 September 2014. A subject was healthy before the vaccination, and had no symptoms such as epilepsy. Unknown date: The subject was vaccinated with the first dose of CERVARIX. Lot number: Unknown. Vaccination site: Unknown. Unknown date: The subject was vaccinated with the second dose of CERVARIX. Lot number: Unknown. Vaccination site: Unknown. Unknown date: The subject was vaccinated with the third dose of CERVARIX. Lot number: Unknown. Vaccination site: Unknown. Unknown date: The subject was diagnosed with brain stem encephalitis after the vaccination. The subject had involuntary movements as a sequela of the brain stem encephalitis, with symptoms of headache and generalised muscle aches, and sometimes complained of photophobia. In addition, the subject had mild memory impairment when she had attack of the involuntary movements, forgetting what happened a short time ago. 22 September 2014: [As of this date] Two years passed since the vaccination. The subject was frequently absent from the school. [Reporter's comment] (Encephalitis brain stem, movements involuntary, headache, generalised muscle aches, photophobia and memory impairment): The causal relationship to CERVARIX was not provided. [Other] Follow-up is now requested including some discrepancy.
Throbbing pain in right shoulder that hasn?t gone away.  It feels like 3 large muscle knots that roll when I  press on them.  Throbbing is it?s worts in the morning after waking up. The pain has woken me up from a sleeping state.  My arm isn?t warm to the touch or red.
Information has been received from a physician concerning a 17 month old white male pt who on 7/26/99, was vaccinated with the 1st dose of MMR and on 8/1/99, the pt developed a macular rash on his face and back and a fever of 100F to 101F. On 8/9/99, the pt recovered. No further information is available.
Information has been received from a physician concerning a 15 year old female who on 23-AUG-2007 was vaccinated on the left side of the arm with a dose of Gardasil (Lot # 655849/0263U).  Concomitant vaccination included MENACTRA.  On 25-AUG-2007 the right side of the patient face became swollen and a rash developed on the injection site.  On 27-AUG-2007 the patient recovered from the right side of her face being swollen and the rash that developed at the injection site.  Additional information has been requested.
After vaccination, patient tested positive for COVID-19.  Patient was very ill and had numerous chronic health issues prior to vaccination.  Facility had a number of patients who had already tested positive for COVID-19.  Vaccination continued in an effort to prevent this patient from contracting the virus or to mitigate his risk.  This was unsuccessful and patient died.
Reported Symptoms: low grade fever, hives ?head to toe? , fatigue, cold sweats and does not feel well at all, feeling  tachycardic and palpitations Date of Onset:  *most symptoms ongoing from 01/11; 01/12/2021 hives Medication taken for Symptoms: ?steroids and Benadryl?
Administed MMR and Varicella Vaccines - one in each thigh.  Patient within five minutes developed erythema on both extremities around sites of injection.  On varicella side- rash spread down lower extremity. Benadryl administered within 10 minutes.  5 minutes after giving Benadryl, rash started to resolve.
Woke about 24 hours after vaccine,  more fatigue than usual, chills, fever, body tingles, immense brain fog, we blister rash around both sides of my neck, migraine induced.
He was having trouble breathing; His heart is working at 25% capacity; This is a spontaneous report from a contactable consumer.  A 77-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 08Mar2021 (Lot number: was not reported) (at the age of 77-year-old)  as single dose for COVID-19 immunisation.  Medical history included wears a heart pacemaker and cholesterol issue, both from an unknown date and unknown if ongoing. On 09Mar2021, the patient experienced trouble breathing, it was reported that his heart was working at 25%.  The patient was admitted to emergency room and subsequently he was hospitalized for 3 days, the events were life-threatening.  The patient outcome of the events was not recovered.  Information about lot/batch number has been requested.
Diagnosed with Invasive Ductal Breast Cancer of left breast in April 2022. It was determined that the size of the cancerous tumor indicated it had been growing for 10 months to 1 year which puts the time the cancer began right after I received the 2 Covid vaccines.
6/18 immunized 6/19 fussy 6/20-6/22 high pitched cry x 20-30min. occurred midday, late afternoon, evening. Evening cry folladied by flexion al elbows and wrists, eye deviations x 10 min. Sleeps after episodes. Awakens normal self.  Seen 6/22 fussy but otherwise normal exam. Labs sent. No treatment.
Extreme pain at injection site, radiating into shoulder and back, caused patient to be unable to use his left arm, and miss several days of school.
As soon as I looked down at my left arm after the nurse had injected the flu shot I notice the injection site was low. The injection site was in the middle of my arm rather than closer to my shoulder like it had been in years past. My left arm felt more sore instantly after the flu injection and to this day it continues to be in pain. I have weakness in my left arm that limits my day to day activities. I experience weakness and throbbing pain in my left arm all through the day and night.
Spoke with patient, he reports that he may have had a severe reaction to Shingrix injection 1/27/21. Patient had an office visit at 0800 on 1/27/21 and received Shingrix injection to left deltoid at the end of the visit. He was at home at 1130 drinking coffee and noticed that he could not swallow. Symptoms progressed to the point he could not breath. The ambulance was called and he was transported to ICU and remained there overnight. They did a complete workup and did not find a cause. Patient denies any new enviromental/chemical irritants, new food/drink, medication, or animals in his life. He states the only new thing was the injection. He denies any form of location injection site reaction or skin rash. He states he also had a HA just prior to his throat swelling. Patient states he has been symptom free since 0500 1/28/21.
Client was given her 2nd Hepatitis B injection and 2 hours after she noticed itching all over her body.  She noted no rash, hives, difficultly breathing, itching or closing of the throat.  Took a warm bath and itching persisted.  She still has itching today all over body but no rash or hives.  Client advised to consult physician today and also ask if she should have final injection in the series.
asthma attack; This spontaneous report was received from a consumer via company representative and referring to a 14-year-old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 18-APR-2023 (also reported as on Tuesday), the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) intramuscular injection, administered for prophylaxis (strength, dose, lot #, expiry date, and route of administration were not provided).  On 23-APR-2023 (also reported as Sunday), cold allergy-like symptoms began. On 25-APR-2023, the patient was admitted to the hospital for severe asthma attack. On 28-APR-2023, the patient was discharged from the hospital. To date, he was still wheezing, but slowly recovering with medication. Therefore, the outcome of asthma attack was recovering.   The causal relationship between asthma attack and quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) was not reported.
many welts on his body; This is a spontaneous report from a contactable consumer (patient's wife). A 59-year-old male patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose on 21Mar2021 via an unknown route for Covid-19 immunization. Medical history and concomitant drug were not provided. The vaccine caused him many welts on his body, although they disappeared with diphenhydramine hydrochloride (BENADRYL). He had the second dose scheduled for 21Apr2021.  No follow-up attempts are needed; Information about lot/batch number cannot be obtained.
Pain in my arm lasting about 4 days.  Itching, swelling, and redness covering about 1/2 of my upper arm, which continues.  I had the vaccine almost one week ago.
Redness around vaccinated area measuring 4 cm. with warm to touch, with itching sensation.
Initial unsolicited report received from consumer (patient's wife) on 12-Oct-2015. This case involves a 67-year-old male patient who was vaccinated with an intramuscular dose of FLUZONE HD (batch number was not on immunization record, expiry date and site of administration were not reported) on 09-Oct-15. It was reported that patient has received yearly flu shots. Patient's illness at the time of vaccination was not reported and patient's Pre-existing physician diagnosed allergies, birth defects, medical conditions included Cardiac on warfarin and baby aspirin (ASA). Other medical history and concomitant medications were not reported. On 10-Oct-15, one day after vaccination, patient developed nose bleed when he bent over from the waist on the deck and is still actively bleeding. Patient had an international normalized ratio (INR) drawn and results pending. Patient has not been evaluated or treated by a physician after which it will be determined if he will be seen by his cardiologist. At the time of report, outcome of the event was reported as unknown. It was reported that reporter was concerned because the information on flu vaccine provided by the pharmacist addressed a possible warfarin/vaccine interaction. Documents held by sender: none.
Pt recv vax on 4/22/99; on same day pt exp warm feeling then a seizure