chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Lack of drug effect; Diagnosed with COVID; This spontaneous case was reported by a consumer and describes the occurrence of DRUG INEFFECTIVE (Lack of drug effect) and COVID-19 (Diagnosed with COVID) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020F21A, 007M20A and 030A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Dec-2021, the patient experienced DRUG INEFFECTIVE (Lack of drug effect) and COVID-19 (Diagnosed with COVID). At the time of the report, DRUG INEFFECTIVE (Lack of drug effect) and COVID-19 (Diagnosed with COVID) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Dec-2021, SARS-CoV-2 test: positive (Positive) Positive test evening.         No concomitant medication reported. No treatment medication details reported. The patient got vaccinated in February and March and then got a booster November first and get breakthrough infections.The patient was confused cause all this just happened. Diagnosed with COVID. On 25-Dec-2021 evening test the positive.  This is a spontaneous case concerning  a  62-year-old, female patient with no relevant medical history, who experienced the unexpected non-serious event of Drug Ineffective and Covid-19 as an added event. The events occurred approximately 54 days after the third dose of mRNA-1273 COVID 19 Vaccine. The rechallenge was unknown since no information about the first dose was disclosed. The events outcome were reported as unknown. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.; Sender's Comments: This is a spontaneous case concerning  a  62-year-old, female patient with no relevant medical history, who experienced the unexpected non-serious event of Drug Ineffective and Covid-19 as an added event. The events occurred approximately 54 days after the third dose of mRNA-1273 COVID 19 Vaccine. The rechallenge was unknown since no information about the first dose was disclosed. The events outcome were reported as unknown. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.
Pt has had lingering Redness and Swelling (several weeks) which she did not feel needed medical attention.  At the time she reported the area was barely visibly red without any swelling.  I urge pt to seek treatment with her doctor if any problems persist but she believes it to be fine and just wanted to report the issues she had with it.
left arm hurting; nauseous; UTI; whole body is hot; This is a spontaneous report from a contactable consumer. A 40-years-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date unknown), via an unspecified route of administration on the left arm, on 19Dec2020 at a single dose for Covid-19 immunization.  The patient medical history and concomitant medications were not reported.  Patient stated that she took the vaccine on 19Dec2020. On an unspecified date, patient stated that she had no side effects only her arm was hurting. She stated that her whole body is hot. Stated that she has no temperature and is a little nauseous. Stated that whererever she lays down at one can feel the heat. She stated that it was Pfizer BioNTech Covid 19 vaccine EUA is concerned. She stated that she went to the ER and they thought it was because she was taking a medication for urinary tract infection (UTI) and that she was having a reaction. She stated that her doctor told her that the second day she would have had side effects to UTI medicine. She stated that the doctor is stating that it is due to the vaccine. She wanted to know if she should go back to the ER. She stated that her doctor told her to call the place where the vaccine was received for them to monitor her. She stated that she went through her job off site and that this was her first shot. She clarified that she received the shot in her left arm and it was hurting. Outcome of the events was unknown.  Information on lot/batch number has been requested.
July 10, 2013 my doc. said "I have tendinitis/cuff and thickening of acromion, but no way to tell if it's life, or improper vaccination. Received flu" shot 9/2012 into my shoulder top, instead of muscle. Enclosed copy or signature and date at pharmacy. Please notify fellow to stop administering vaccinations this way!  Thank you!
Patient presents noting a reaction at the site of her varicella immunization. Notes it became red, warm, and swollen. She has itching at the site. No respiratory symptoms or swelling of the face/hands/feet. She notes no fevers, chills, or other systemic signs of illness. She has not tried any antihistamines or cold packs.
Patient is reporting fever, chills, patient fainted hours after getting vaccination. Paramedics were called, and patient is feeling a bit better but not great.
Patient received a first dose of Pfizer vaccine around 10am on 05/16/2021. Around 6pm on 05/17/2021, patient's mother called and stated that her daughter feels difficulty breathing,  SPO2 at 94, heaviness in chest (she describes like an object was sitting on her chest) and chest pain (on scale 0-10, with 10 is the most intense pain, pt reported 8/10). In addition, pt has been experiencing chills since the day of the vaccination. Parent gave the child ibuprofen before calling pharmacy. Pt 's mother reported that her daughter dose not take any medication nor any herbal supplement. The daughter has a history of heart murmur. Based on the severity of the symptoms, we advised the mother to take her child to emergency care.
Onset 1/18/02 with local redness, swelling and itching at injection site.
pt recvd vax & 9JUN93 & vax devel a t104 & pt recovered; No further details were provided;
Two days post vax, this pt experienced induration and redness at injection site for one week. The pt reportedly recovered from this experience. It was noted that the flu vax may have been given SQ.
Patient received a PEDIARIX that was her second dose of DTAP, and Polio and her third Hepatitis B. The Hep B dose was too early to be her final dose.
Pt received 2nd flu vaccine (11/20/12 and 12/20/12) about 10 min later pt vomited and had an apnea episode. Pt did feed prior to the visit.
headache, sore throat, productive cough at times, body aches, loss of taste, loss of smell, diarrhea not abnormal, sinus congestion, nasal congestion, post nasal drainage, chest tightness, sneezing, ear fullness, itchy eyes. starting 9/30/21
Palpitations after Dose 2; This spontaneous case was reported by an other health care professional and describes the occurrence of PALPITATIONS (Palpitations after Dose 2) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 011520A) for COVID-19 vaccination.     The patient's past medical history included Hypersensitivity reaction and Hives (Urticaria). Concurrent medical conditions included Drug allergy (itching on body) since 14-Apr-2014, Hyperlipidemia since 07-Apr-2009, Gastroesophageal reflux disease since 07-Apr-2009, Hepatic cyst since 21-Feb-2012 and BPH since 24-Apr-2020. Concomitant products included TAMSULOSIN HYDROCHLORIDE (FLOMAX RELIEF) from 27-Dec-2021 to an unknown date for BPH, TADALAFIL (CIALIS) from 27-Dec-2021 to an unknown date for Erectile dysfunction, OMEPRAZOLE from 30-Mar-2018 to an unknown date for GERD, MAGNESIUM CHLORIDE from 10-Feb-2021 to 27-Dec-2021 for Nutritional supplement.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. In February 2021, the patient experienced PALPITATIONS (Palpitations after Dose 2). At the time of the report, PALPITATIONS (Palpitations after Dose 2) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Electrocardiogram: normal (normal) normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information was provided.  Patient had no allergies to food, other medications, asthma, hay fever and environmental factors that was known. It was unknown if patient had allergic history of anaphylaxis and had any previous history of allergic/hypersensitivity reactions to vaccine. Patient noticed palpitation for two weeks in Feb 2021 post dose two. Patient started his concomitant drug magnesium chloride.   This case was linked to MOD-2022-456526 (Patient Link).
Information has been received from a Registered Nurse, for the Pregnancy Registry for GARDASIL, concerning a 15 year old female with no medical history and drug reactions/allergies, who on 11-AUG-2009, 16-OCT-2009 and 11-MAR-2010 was vaccinated with intramuscularly with the first, second and third doses of GARDASIL (lot# for the last dose was 662304/1013Y) respectively. There was no concomitant medication. On 25-MAR-2010 the patient discovered that she was pregnant and that the conception time was near the final injection time. The patient's LMP was approximately 22-FEB-2010 (currently about 5 weeks into the pregnancy). Unspecified medical attention was sought. There were no lab diagnostics studies performed. No known adverse reactions were available. Follow-up information was received from the registered nurse concerning a 15 year old pregnant female with a history of 0 pregnancies and 0 live births and with no other medical history who on 11-AUG-2009, 16-OCT-2009 and 11-MAR-2010 was vaccinated intramuscularly with the first, second and third doses of GARDASIL (lot# for the third dose was 662304/1013Y) respectively. Concomitant therapy included OTC prenatal vitamins (PNV) (25-MAR-2010 to present) which was used for pregnancy. The patient's LMP was approximately 22-FEB-2010 and her estimated delivery date was 15-NOV-2010. On 30-APR-2010 HPV test showed HPV positive. On 01-MAY-2010 (11 week 3 days) ultrasound was performed for testing size and date and it showed there were abnormal cranial vault, no normal cerebral, hemispheres or choroid and portion of baby "calictium" absent. Then on 11-MAY-2010 (12 week 2 days), ultrasound was performed again and showed results within normal limits. On an unspecified date the patient experienced anemia which was treated by ferrous sulfate (since late July 2010, 325 mg daily). In August 2010, at 28 weeks of gestation, the patient experienced preterm labor (PTL) which was treated by betamethasone (from 27-AUG-2010 to 28-AUG-2010, 12 mg x2). On 27-AUG-2010 the patient experienced bacterial vaginosis which was treated by cytarabine (+) fludarabine phosphate (+) granulocyte colony stimulating factor (unspecified) (from 27-AUG-2010, duration 1 week, 500 mg twice a day). It was reported that the baby also experience intrauterine growth regardation (IUGR) on an unspecified date. On 05-NOV-2010, at 38 1/2 weeks (also reported as 38 6/7 weeks) of gestation, the patient delivered a normal, healthy male baby weighing 5 pounds 7. Apgar score was 9/9. Baby's length was 19 inch and head circumference was 81.5. There were no congenital anomalies reported. There were no complications during labor. However, the reporter thought the baby was delivered at small gestation age (SGA). Other laboratory test included: fetal fibronectin test (FFN) which was performed on 27-AUG-2010 and showed positive result. Gestational Blood Sugar (GBS) which was performed on 12-OCT-2010 and showed negative. The baby's experience has been captured in WAES 1004USA00203B1. Additional information has been requested.
Narrative: COVID infection following COVID vaccine series 07/22, Pfizer, dose #1 08/13, Pfizer, dose #2 12/22 COVID swab, result: detected 12/20 pt cc: fever, headache, myalgias, dyspnea, sore throat exposure: unknown
Patient walked to waiting area and when he sat down he fainted, hit his head, and started having seizure-like activity (jerky, twitchy). Patient was down about 15 seconds and when he sat back down his blood pressure was 74/48 and his vision was black. Called EMT, patient refused to go with EMT, because he felt better after 30 minutes of sitting
Adult dose (1ml) of Engerix was administered to patient <19 years of age. Nursing supervisor and onsite NP notified of error. Legal guardian of pediatric patient also notified.
Severe pain and stiffness in injection arm 5 hours after vaccine.  The next morning woke up with fever of 101.6 & body aches. Also experienced headache, nausea, diarrhea, lightheadedness, severe fatigue. About 50 hours after vaccine, experienced large, itchy, red rash 2" in diameter around injection site.
a little soreness in the arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 72-year-old male patient received bnt162b2 (BNT162B2), administration date 29Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1 dose), for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "a little soreness in the arm".  Additional information: The patient enquired that if it was true that Tylenol should not be taken before receiving the Pfizer BioNTech COVID-19 vaccine. The patient stated that he and his wife received their second shot on Monday and his wife had taken Tylenol before getting her vaccine. The patient reports that both he and his wife experienced a little soreness in the arm after their vaccinations.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021361581 same reporter/drug/AE, different patient
GARDASIL and Tetanus given on 6/12/12. Started having chest pain, numbness in arm on 6/18/12. Went to doctor and he said it was panic and costochondritis. Continued having same chest pain and leg numbness, paralysis of legs. Went back to doc. Then went to ER 6/25/12 - lips numb, chest pain, headache.
Low level of chronic rashes from eczema and/or contact dermatitis grew markedly worse with rashes spreading in new ways and becoming dramatically harder to control. Been itching like mad for four months. Some attempted treatments (antifungal) have caused worse outbreaks, requiring oral steroids to resolve. Had one tele-health visit during an acute phase, plus one in-person visit with my primary care. Nothing so far as worked to get me back to my pre-vaccine equilibrium. Am 8 days into a radically exclusionary diet now, but that hasn't helped, nor has trying to vary environmental factors (like soaps, laundry detergent, etc.). Waiting several more months to see a dermatologist.
Bells Palsy; This is a spontaneous report from a contactable consumer (patient). A 30-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0171, expiration date not reported), via an unspecified route of administration, administered in Left arm on 30Apr2021 14:00 (at the age of 30-years-old) as 2nd dose, single dose for covid-19 immunisation. Medical history was reported as none and the patient had no known allergies. The patient did not receive other medications in two weeks of vaccination. The patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: ER8732) via an unspecified route of administration, administered in Left arm on 09Apr2021 14:00 as 1st dose, single dose for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. On 21May2021 at 16:00, the patient experienced Bell's palsy and was treated with Antiviral / steroid prescription. The adverse event resulted in emergency room/department or urgent care. The reporter assessed event as non-serious with no seriousness criteria of resulting in death, Life threatening, Caused or prolonged hospitalization, Disabling or Incapacitating, Congenital anomaly or birth defect. The outcome of the events was recovering.
angiodema; Urticarial Vasculitis; hypoxia; urticaria/hives; This spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On or about 18-SEP-2013, the patient was inoculated in the clinic with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiry date were not provided) as recommended for routine adult health maintenance for the prevention of shingles. From an unknown date, she was treated for urticarial/hives. Subsequently she was treated for angioedema in the emergency department. Subsequently, she was treated for urticarial vasculitis and hypoxia from unknown dates. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, and/or despite receiving zoster vaccine live (ZOSTAVAX) for the long-term prevention of shingles, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a direct and proximate result of these malfunctions, she suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient suffered and would continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was not provided.  The events were considered to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review, the events of angioedema, urticarial vasculitis and hypoxia were considered to be medically significant.; Sender's Comments:  US-009507513-1910USA005083: US-009507513-1910USA005082: US-009507513-1910USA005066: US-009507513-1910USA005084:
NO ADVERSE EVENT REPORTED, VACCINE WAS EXPIRED ON 02/09/2017, WAS ADMINISTRED TO PT.
Pain in the left arm with 2nd shot; Patient concern about 2nd dose administered 2 weeks before indicated schedule; Patient breastfeeding administered with first 2 shots; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in the left arm with 2nd shot), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient concern about 2nd dose administered 2 weeks before indicated schedule) and MATERNAL EXPOSURE DURING BREAST FEEDING (Patient breastfeeding administered with first 2 shots) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 070H21A) for COVID-19 vaccination.     Concomitant products included MAGNESIUM and ZINC for Supplementation therapy.    On 10-Jan-2022, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jan-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient concern about 2nd dose administered 2 weeks before indicated schedule) and MATERNAL EXPOSURE DURING BREAST FEEDING (Patient breastfeeding administered with first 2 shots). On 11-Jan-2022, the patient experienced PAIN IN EXTREMITY (Pain in the left arm with 2nd shot). On 10-Jan-2022, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient concern about 2nd dose administered 2 weeks before indicated schedule) and MATERNAL EXPOSURE DURING BREAST FEEDING (Patient breastfeeding administered with first 2 shots) had resolved. On 12-Jan-2022, PAIN IN EXTREMITY (Pain in the left arm with 2nd shot) had resolved.            No Treatment information was reported.   This case was linked to MOD-2022-449528 (Patient Link).
about 2 weeks after moderna booster shot I have developed  strong case of dermatographia.   Any touch of my skin causes it to be inflamed.  This condition has been going on for 1.5 weeks so far.  Prior to this I have never had any allergic reactions
Patient received MMR, Varicella, and Hep B at Pediatrics and was advised to obtain the TDAP and Influenza vaccine at pharmacy on 9/17/18. A week following the five vaccinations patient began to have symptoms including low grade fevers, fatigue, malaise, and H/A. Patient has now developed a rash on the forearm bilaterally as well as all over his back. Patient was seen at PCP today for treatment. Patient was prescribed prednisone for treatment of the rash and orders were placed for labs including CBC, CMP, and EBV antibodies.
31MAR97 rash to torso, arms, legs, face, & irritable;no tx;
Pt Came back to office at 11:55 reporting allergic reaction to polio vaccine. Mother stated happened about 20 mins prior estimated 11:30am. Pt presented with Hives on face. Grabbed NP to assess. NP ordered Benadryl in office. Pt stayed for 20 minutes, Hives went away, gave Mother Nurse Advice Number and Mother stated she would call if anything more happened.
Dizziness; Headache; Fatigue; Nausea; This is a spontaneous report from a contactable consumer, the patient. A 32-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the right arm on 01Apr2021 (at the age of 32-year-old) as a single dose for COVID-19 immunisation. Medical history included birth control. Concomitant medications included norethisterone (ERRIN) birth control from an unknown date indicated for birth control. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 03Apr2021, the patient experienced dizziness, headache, fatigue and nausea. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had been tested for COVID-19. On 05Apr2021, the patient underwent nasal swab test and the result was negative. The clinical outcome of the events dizziness, headache, fatigue and nausea was not resolved at the time of report.  No follow-up attempts are needed. No further information is expected.
@ 4:00p on 8/10/05 father found client on the floor "frothing at the mouth with eyes rolled back" x 15 min.  At bedtime, client in bed with Mom, had x 1 gran mal seizure.  Client has history of seizures since 2001 but hasn't had any seizures for the past 2 years.  No additional terms found in records  rec'd 12/22/2005/sr