chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (heart racing), VACCINATION SITE REACTION (covid arm), VACCINATION SITE WARMTH (Injection felt hot to the touch), VACCINATION SITE INDURATION (Injection site hardness) and VACCINATION SITE RASH (Injection site rash) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 14-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Mar-2021, the patient experienced PALPITATIONS (heart racing), MYALGIA (muscle pain) and FATIGUE (Fatigue). On 21-Mar-2021, the patient experienced VACCINATION SITE REACTION (covid arm), VACCINATION SITE WARMTH (Injection felt hot to the touch), VACCINATION SITE INDURATION (Injection site hardness), VACCINATION SITE RASH (Injection site rash) and VACCINATION SITE ERYTHEMA (Injection site redness). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, PALPITATIONS (heart racing), VACCINATION SITE REACTION (covid arm), VACCINATION SITE WARMTH (Injection felt hot to the touch), VACCINATION SITE INDURATION (Injection site hardness), VACCINATION SITE RASH (Injection site rash), MYALGIA (muscle pain), FATIGUE (Fatigue) and VACCINATION SITE ERYTHEMA (Injection site redness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 17-Jun-2021: Non significant follow up received on 17-JUN-2021, no new information
Began to notice sporadic twitching/muscle spasm events, almost exclusively in the inner thigh area of both legs several weeks after receiving the second dose of the Pfizer/BioNTech Covid vaccine. This was the first time I remember experiencing these sensations. Since they aren't debilitating, I haven't sought medical consult/diagnosis/testing of any sort. I noticed it most pronounced during October/November/December 2021, when I was in a higher altitude (4000 - 5000 feet) area, which I'm not sure if there is any correlation to or not.
Information has been received from a consumer concerning her 21 year old daughter with a history of penicillin allergy who in "the beginning of" August 2007, was vaccinated intramuscularly with her first dose of Gardasil.  At "the end of" September 2007, the patient was vaccinated intramuscularly with her second dose of Gardasil.  There was no concomitant medication.  On 07-OCT-2007, the patient had a pregnancy test which was positive, and showed that she was 6 weeks pregnant.  An ultrasound showed that the baby had no kidneys (not further specified).  On 22-JAN-2008 the patient experienced a miscarriage and was hospitalized.  The reporter also stated there may have been "fluid on the brain".  Additional information has been requested.
A left arm pit has been swollen; A left arm pit has been swollen and leading to difficulty in movement of left hand and arm movement significantly; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 07Apr2021 at 18:15 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included prenatal tablets (MANUFACTURER UNKNOWN) on an unknown date for unknown indication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 17Mar2021 at 14:30 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. It was reported that the patient had no allergies to medications, food, or other products. The patient did not receive any vaccination within four weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 08Apr2021 at 20:00, the patient's left arm pit has been swollen and leading to difficulty in movement of left hand and arm movement significantly. The patient did not receive any treatment for the events. The clinical outcome of the events left arm pit has been swollen and leading to difficulty in movement of left hand and arm movement significantly were not recovered at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Information has been received from the authors in a published literature article, title below, regarding a 3 year old male infant. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On an unknown date, at the age of 1 year, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (manufacturer unknown) (dose, strength, frequency, route of administration, lot number and expiration date were not provided) in the right thigh for prophylaxis. On unknown date, at the age of 3.5 years, the patient experienced a severe rash in the right thigh and lower back, mainly along dermatome L3 and diagnosed with herpes zoster (shingles). She patient was recovered on an unspecified date. The author considered the events to be related to the suspect therapy. The author stated in some immunized children, virus reactivates within a few months to a few years to cause the dermatomal exanthem known as herpes zoster (shingles). Herpes zoster induced by varicella vaccination usually occurs within months to a few years after the vaccination in immunocompetent children. This is one of 3 cases from the same literature article 1901USA011678, 1902USA002563 and 1902USA002564. A copy of the published article is attached as further documentation of the patient's experience. Sender's Comments: US-009507513-1901USA011678.
Patient reported slight arm swelling, sweat/chills, headache, & vomiting night after receiving FLUZONE vaccine & said was feeling better in the morning.
Burning on the right side of my body 10:45  Tingling, then numbness 11:05
Pfizer / BioNTech / COVID-19 Treatment 03Aug2022; Pfizer / BioNTech / COVID-19 Treatment 03Aug2022; Rebound Covid; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 33-year-old female patient received BNT162b2 (BNT162B2), on 23Dec2020 as dose 1, single (Lot number: EH9899), in left arm, on 14Jan2021 as dose 2, single (Lot number: EK4176), in left arm and on 26Sep2021 as dose 3 (booster), single (Lot number: 30145BA) at the age of 32 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "pregnancy" (unspecified if ongoing); "asthma" (unspecified if ongoing). Concomitant medication(s) included: SERTRALINE, start date: Jun2012; PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS], start date: Sep2021.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "Pfizer / BioNTech / COVID-19 Treatment 03Aug2022"; DISEASE RECURRENCE (medically significant), outcome "recovering", described as "Rebound Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: Tested negative and symptoms resolved after course of Paxlovid on day 5; Positive, notes: Return of symptoms and repeat positive antigen test on day 10. Therapeutic measures were taken as a result of vaccination failure, covid-19, disease recurrence.  Clinical course: Report about covid treatment: Yes, If vaccine received: Yes, Other medication in 2 weeks: Yes. Rebound Covid. Tested negative and symptoms resolved after course of Paxlovid on day 5. Return of symptoms and repeat positive antigen test on day 10. Remain positive and symptomatic still on day 16 from initial infection (day 6 from rebound start).  No follow-up attempts are possible, no further information is expected.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events vaccination failure, covid-19 and disease recurrence and BNT162B2.
Tinnitus in both ears. no polarity , no relief, constant ringing in ears. First emerged ~1week after 2nd dose. Persists until today
20-30 after injection developed a rash over arms, chest neck and face that was red. states she felt very lightheaded and nauseated. Benadryl, Zofran, Pepcid given.
This case was reported by a lawyer and described the occurrence of rheumatological symptoms in a male subject of unspecified age who was vaccinated with LYMERIX (GlaxoSmithKline).  A physician or other health care professional has not verified this report.  On an unspecified date the subject received unspecified dose of LYMERIX (unknown).   According to the statement of injuries, at an unspecified time after vaccination with LYMERIX the subject experienced "pain and swelling in his joints, fatigue, tingling in his extremities, memory loss, cognitive problems, visual problems, and decreased activities of daily life".  The statement of injuries also alleged that the subject experienced "rheumatologic, neurologic, and/or cognitive impairment of an autoimmune, immune-mediated, or other mechanism all caused by vaccination with LYMERIX including but not limited to those set forth above."  At the time of reporting the outcome of the events was unspecified.  Follow-up information was received on 22 September 2008 in the form of medical records.  On 02 June 1998, the subject was seen for recurrent knee pain and swelling.  It was reported that a recent Lyme test was positive (Elisa at 1.46 with a positive cut-off being anything greater than 1), but the more specific test was negative (Western blot).  The subject explained that he may have had a tick bite at the end of last summer or fall, but noted no associated erythema migrans, history of Bell's palsy, palpitations or history of heart block.  The subject noted a deer tick crawling on him in the spring, but it had not embedded.  He had become concerned when he developed left thoracic pain.  This was a numbness or tingling pain over approximately T-4 distribution.  Lyme's disease was expected at this point although not confirmed with diagnosis.  An exam dated 06 March 2003 indicated that the subject had Lyme's about three years prior and had been on doxycycline at that time.  The subject recently had blood work and tested positive for one band in the Lyme's.  An evaluation dated 09 April 2003 reported that the subject had been experiencing significant hypertension and sleep apnea.  These conditions were just incidental findings from review of medical records.  It was additionally mentioned at this time that the subject had been undergoing treatment with doxycycline over the last several months for presumptive mycobacterium marinum infection of the hand.  This condition was also evaluated back in 23 January 2003.  The subject was evaluated by a physician on 11 November 2004.  The subject had been seeing a Lyme specialist and undergone 6 months of antibiotic treatment.  He received oral clindamycin, metronidazole and cephalosporin all at one time.  The subject was also placed on BENICAR for some symptoms of hypertension which was just an incidental finding at this point in review.  It was reported that the subject suffered from psoriatic arthritis.
Patient is not Immune compromised however, received a third full Moderna Covid-19 dose for his first booster dose.; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL OVERDOSE (Patient is not Immune compromised however, received a third full Moderna Covid-19 dose for his first booster dose.) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 02-Nov-2021, the patient experienced ACCIDENTAL OVERDOSE (Patient is not Immune compromised however, received a third full Moderna Covid-19 dose for his first booster dose.). At the time of the report, ACCIDENTAL OVERDOSE (Patient is not Immune compromised however, received a third full Moderna Covid-19 dose for his first booster dose.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided by reporter.  The patient is not Immune compromised however, the patient received a third full Moderna Covid-19 dose for his first booster dose.  No treatment medication was provided by reporter.
Patient spike a fever of 102, became "unconsolable and rigid" within 2 hours after receiving vaccine. Also site of vaccine became "hard as a rock" and "bright red" and hour after administration and patient not able to walk, mom described as "lethargic". Patient dev swollen glands in neck several hours after shot. Similar reactions on 11/15/07 and 3/14/08 to DTaP-HPV-Hep B, HIB, PREVNAR- mild rxn to VARIVAX - No rxn to HIB alone.
Pt noticed that when it was administered at her Gynecologist office 3 weeks ago,  it was given at a higher site than usual. She also noticed that it stung much worse than any other vaccine. Pt has swelling size of a 50 cent piece with arm at rest. Pain 7/10 area slightly warm. She thought it would go away on its own but it didn't. Was washing her car yesterday after which it felt worse.
Information has been received from a nurse concerning a 15 year old female who was vaccinated with the third dose of GARDASIL vaccine 0.5 mL (Lot # 660393/0067X). The nurse reported that they kept the patient for approximately 10-15 minutes after administration and then on her way out, as she was passing the receptionist desk; she passed out and bumped her head. When she come to; she vomited. She was take to the ER, but the physician's office had not heard any follow up on her condition as of the time of the report. Additional information has been requested. This is one of several reports from the same source.
lump developed in my left breast/abnormal breast tissue forming.; left breast became very swollen and painful; left breast became very swollen and painful; felt very weak; tired; tenderness in my left breast; This is a spontaneous report from a contactable consumer (patient). A 69-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: el 9266), via an unspecified route of administration in arm left on 16Mar2021 at 08:30 (at the age of 69-year-old) as a dose 2, single for COVID-19 immunization. The patient's medical history included COPD and irregular heart rate. The patient's concomitant medications received within 2 weeks of vaccination included Tadalafil, simvastatin (ZOCOR), carvedilol (COREG), amlodipine, mirabegron (MYRBETRIQ) and spiq. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: el9266), via unspecified route of administration in arm left on 23Feb2021 at 08:30 (at the age of 69-year-old) as a dose 1, single for COVID-19 immunization. It was reported that, the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, has the patient been tested for COVID-19 was reported as no. About 3 weeks after second shot felt very weak and tired. Then started to have tenderness in her left breast. Around 01May2021, left breast became very swollen and painful, then a lump developed in her left breast. The doctor had a mammogram and ultrasound done. It was determined that, it was abnormal breast tissue forming. She scheduled a preop with a surgeon in the next few weeks. On 14May2021, the tenderness and lump started to reside, today Sunday on 16May2021, the lump was 95% smaller that last week, the swelling was gone and only have a very small amount of tenderness. The events resulted in doctor or other healthcare professional office/clinic visit. Treatment received for the events was not reported. On an unspecified date in Apr2021, the patient underwent lab tests and procedures which included mammogram, resulted as abnormal breast tissue forming and Ultrasound, resulted as abnormal breast tissue forming. The device date was on 16May2021. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Patient was given her first two doses of Pfizer vaccine on 1/29/21 and 2/19/21 then she received the Moderna Vaccine on 11/2/21 at residence where she currently resides.  Per the provider she did not see this on her immunization list and asked patient who stated she had not received her Booster so they ended up giving her another Pfizer booster on 12/23/21.
I experienced uncomfortable stomach pain within the first hour of receiving the shot (intramuscular, right hip).  Within 3 hours I was experiencing sharp knifing pain in my lower intestines and this lasted approximately 12 hours after receiving the shot.  Within 24 hours the injection site was swollen and red over an area of 2"x5".  The swelling and redness lasted 6 days.  Approximately 8 days after the injection, I noticed pain and swelling in the inguinal (groin) lymph nodes near the injection site.  It is now 12 days after the injection and the lymph nodes are still painful and swollen (the width and breadth of the swelling approximates the size of an adult thumb), to the point that I cannot sleep on my right side at night.  I called my doctor but her clinic is an hour's drive away and I will not schedule an appointment unless the condition continues to persist.
This is one case out of a cumulative total of 210 cases solicited from the EDSS database during the surveillance period from 01 January 2010 to 23 August 2013. These 210 cases represent children who received 3 or more doses of sanofi pasteur vaccine; cases of pertussis disease in children who received DTaP combination vaccines from other manufacturers are not reported as per study protocol. Initial report received on 23 August 2013 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis disease in a 03-year-old male subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received 3 doses of PENTACEL received on 07 April 2010 (batch number C3591AA), 28 June 2010 (batch number C3591AA), and 17 September 2010 (batch number C3633AA) and 1 dose of DAPTACEL (batch number C3380AA) on 27 May 2011. The subject developed a cough on 01 July 2013, i.e. 766 days after the last dose, and a paroxysmal cough with a whoop on 01 July 2013. The subject also developed post-tussive vomiting and sleep disturbance on an unspecified date. Laboratory testing included positive PCR and positive culture on 22 July 2013. Chest x-ray findings were unknown. Corrective treatments consisted of azithromycin starting on 22 July 2013 for 5 days. The subject was not hospitalized. At the time of final contact on 14 August 2013, the subject's cough was still persisting. The duration of the cough was reported at that time as 35 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
body aches; chills; tested positive for Covid-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive for Covid-19), MYALGIA (body aches) and CHILLS (chills) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007M20A and 011L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021 at 3:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Jan-2021, the patient experienced COVID-19 (tested positive for Covid-19). On 04-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MYALGIA (body aches) and CHILLS (chills). On 05-Feb-2021, MYALGIA (body aches) and CHILLS (chills) had resolved. At the time of the report, COVID-19 (tested positive for Covid-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Jan-2021, SARS-CoV-2 test: positive Positive.         No concomitant medication information was provided. No treatment medication information was provided.   This case was linked to MOD-2021-012786 (Patient Link).; Sender's Comments: This case concerns a 58-year-old male patient with no medical history, who experienced expected events of Myalgia, Chills and unexpected evet of COVID-19. The events of Myalgia and Chills occurred on the second day after receiving the second dose of mRNA-1273, Moderna COVID-19 Vaccine. The event of COVID-19 occurred on the second day after receiving the first dose of mRNA-1273, Moderna COVID-19 Vaccine. The rechallenge is Not applicable.  The benefit-risk relationship of  mRNA-1273, Moderna COVID-19 Vaccine is not affected by this report.
First noticed lump at injection site, was told by phsician that it was hematoma. Three days later notice rash on back, stomach, arms and face and fingernails were yellow. Given prednisone by physician x 8 days. Treatment successful.
same day started with a Headache and redness at the injection site that progressively wosened to approximately 2 inches in site. It was tender to touch and developed numbness and tingling and neck pain approximately 24 hours after the injection. Pt has taken aleve for comfort. Denies fever or difficulty breathing and c/o itchiness at the injection site.
After administration, vial was noted to have gone past its Beyond Use Date.  BUD was 12/31/21 and dose was administered on 1/4/22.  Patient did not experience any reactions.
PATIENT REPORTED ANXIETY, TACHYCARDIA, DRY MOUTH 5 MINUTES POST VACCINATION. BROUGHT HER TO COUNSELING ROOM TO ASSESS. AFTER WATER AND A SNACK SHE WASN'T GETTING BETTER. CHEST STARTED TIGHTENING, ESOPHAGUS WAS TIGHTENING AND TONGUE STARTED TO FEEL FUNNY WITHIN ABOUT 5 MINUTES OF HER COMING INTO THE COUNSELING ROOM, SO I ADMINISTERED AN ADULT DOSE OF EPI-PEN. WE CALLED EMS WHO TOOK ABOUT 25 MINUTES TO RESPOND AND THEY TRANSFERRED HER TO LOCAL ER. WITHIN THE TIME WE AWAITED EMS HER TONGUE SWELLING AND BREATHING IMPROVED, STILL ANXIOUS AND TACHYCARDIC (EPI SIDE EFFECTS) BUT WAS FEELING BETTER. DID GET CHILLS (LIKELY EPI SIDE EFFECTS). TRIED TO FOLLOW UP WITH PATIENT 9/3/21 AND LEFT VOICEMAIL TO SEE HOW SHE WAS DOING / IF THERE WAS A REGULAR DOCTOR WE COULD CONTACT.
Only minor chills before bed, 11pm. Muscle aches, felt as tightness in IT bands, made remaining asleep difficult. Got up to use the bathroom around 5am. Upon finishing peeing while standing, I lost consciousness, falling. As a result of the fall, I fractured my cheek bone, cut open my ear, later requiring three stitches, and was concussed, resulting in a loss of memory. I was nonresponsive when my fiance found me immediately following the crash, and was rushed to the hospital  via ambulance. Upon arrival to the hospital, my fever was found to be 102 F. As a result of the fall, I have a cheek bone fracture, three stiches in my ear, and a concussion.