chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID-19 confirmed by positive COVID-19 test; COVID-19 confirmed by positive COVID-19 test; This is a spontaneous report from a Pfizer-sponsored program, Pfizert. A contactable male consumer of unspecified age reported that he received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 05Jan2021, for COVID-19 immunization. Medical history and concomitant medications were not reported. On 07Jan2021 the patient tested positive with Covid-19. He had to receive the second BNT162B2 dose on 26Jan2021. Event outcome was unknown. Information on the lot/batch number has been requested.
Area of injection has red warm area 8 1/2 x 13 1/2 cm.
Having Diarrhea pretty bad really dark; I am not feeling good; Having Diarrhea pretty bad really dark; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Batch/Lot number: unknown) for immunisation; for immunisation; elasomeran (MODERNA COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for immunisation; influenza vaccine (FLU VACCINE VII), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIARRHOEA (non-serious), FAECES DISCOLOURED (non-serious), outcome "unknown" and all described as "Having Diarrhea pretty bad really dark"; MALAISE (non-serious), outcome "unknown", described as "I am not feeling good".  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v, rsv vaccine prot.subunit pref 2v  has been requested and will be submitted if and when received.
After 12 hours, chills, fever, nausea, headache, vomiting, digestion stopped. Significantly better after 36 hours.
Pfizer-BioNTech COVID-19 Vaccine - Patient received the second dose of their vaccine and within 5 minutes of being in the waiting area after the vaccine began feeling slightly faint.  I went over and talked with the patient who told me she was feeling faint.  I immediately elevated her legs and had someone get a cool cloth and water for her.  She told me this is a normal anxiety type reaction for her after getting vaccines.  I had her remove her mask and take deep breaths and she reported feeling better.  Once the faintness subsided after about 5 minutes I helped her to an outdoor area to get fresh air and elevated her feet again just to make sure she was ok.  We continued to observe her for 30 minutes and she reported feeling better and left.
7/18/14 1300 3 x 5 cm redness, sl induration; redness started 7/17/14 pm. 7/20/14 had large redness at site of injection with tingling down (R) hand w/itching. BENADRYL 25 mg. Had taken TYLENOL qd first 3 days. 7/22/14, 0830 sl. redness 1/2 cm, no induration, no itching, without pain.
TESTED POSITIVE FOR COVID-19; MEDICATION ERROR; INJECTION SITE HURT A LITTLE; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included bnt 162 for prophylactic vaccination. On an unspecified date, the patient experienced tested positive for covid-19, medication error, and injection site hurt a little. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the tested positive for covid-19, injection site hurt a little and medication error was not reported. This report was non-serious. This report was associated with product quality complaint : 90000200149. This case, from the same reporter is linked to 20211102956.
bright red rash on arm that started as a 5x5 inch patch on the arm noticed at 0400 am when woken to severe itching.  called county health nurse that gave the vaccine.  she indicated a antihistamine and cold pack remedy should be followed and not needed to see a doctor.  One day later patch of red had grown to cover most of the upper arm on three sides.
09/06/11 PNUps (Pneumococcal polysaccharide, pneumonia), Tdap (ADACEL) (Tetanus, diphtheria, acellular pertussis), office visit, blood pressure - 142/82. 09/19/11 Follow up office visit, blood pressure - 162/82. 09/21/11 Office visit - feeling sick- blood pressure: 188/98. 9/22 - 9/25 Getting progressively worse. 09/26/11 Hospital Emergency, sick, can't walk. Spinal tap, diagnosis of GBS, 5 nights of IV/IG plus steroids. 09/30/11 Transfer to rehab center. 10/12/11 Transfer to hospital. 10/14/11 Transfer to skilled nursing for recovery. 11/04/11 Transfer to home. 11/10/11 Back to hospital by paramedics due to inability to breath. 11/11/11 Begin 5 nights of IV/IG plus steroids. 11/16/11 Transfer to home.
Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown. Not Provided          Treatment information were not provide.   This case was linked to US-MODERNATX, INC.-MOD-2021-091772, US-MODERNATX, INC.-MOD-2021-092438 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-091772: US-MODERNATX, INC.-MOD-2021-092438:Case for son.
After vaccine on 4/18/2021, major chest pain, shortness of breath, fatigue and sweats began. 4/22/2021- went to Urgent Care doctor advised to go in ambulance to hospital, 4/22/2021 I was admitted in hospital for pericardial effusion and had surgery on 4/26/2021 for pericardial Effusion Tamponade.I was in the hospital for 8 days. No pre-existing conditions prior. Treatment was to surgically remove fluid from sac & drain, oral Colchicine for 3 months to prevent immediate inflammation. Continue to follow up with Cardiologist to check for effusion.
Hypertension,  tachycardia, and shortness of breath for one hour. Burning sensation on the injection site.
After the needle retracted, I noticed about a quarter-size swelled mass right where the vaccine was given.  I immediately asked the patient how they felt and she said she didn't feel any different and only was thrown off by the sound of the retracted needle.  I asked her to wait in the seat and immediately called the CDC to check if this was a common reaction.  The gentleman explained that it sounded more generalized and to just make sure the patient didn't exhibit any other symptoms.  I rechecked her arm and the swelling was completely gone just the redness at the injection site.  I had her wait another 15 minutes to make sure there were no new symptoms before I let her go ahead and leave.  I instructed her to contact the Dr. immediately if she noticed any new symptoms.
15 hours later developed fever, staring spell x 2 minutes. Presents with fever 101.2 in office. Otherwise no symptoms. Event reported due to close temporal with vaccinations.
Arm was sore as a normal vacination would cause but after the initial two days the tenderness became a quickie and ached.  It has been almost three weeks and is getting worse.  My shoulder is waking me up at night and is causing pain when doing daily activities. I reported the event to our employee health nurse on 10/24/11 who advised me to report this event and to follow up with my PCP if it continues.
Patient stated that after both shots she had server pain in her Arms. After a week after the second Vaccination she started having chest pain. She went to the ER three times with in 5 weeks after having the vaccine. Patient stated that she finally went to a better hospital and was diagnosed with  Peracarids. She is still experiencing bad chest pains.
Fluttery feeling occasionally in heart. Chest became extremely tight where it felt like it someone was standing on my chest. Even had to remove bra because it felt like I was being strangled. The feeling came and went through out the night.  I occasionally still get a fluttering stinging feeling in my left upper chest.
The first day, the pt experienced localized redness and swelling, pain at the site of injection. The second day, the redness was spreading, pain and swelling approximately 6 inches in diameter. Third day, redness and back of arm pain, spreading continued on arm for 10 minutes.
Received moderna booster vaccine 12/16/21. Positive pregnancy test on 12/20/21. No heartbeat on ultrasound 01/19/22. Missed miscarriage. May need cytotek and possible D&C procedure.
Headache; Muscle aches; Fatigue; Swollen lymph nodes under arms; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the left arm on 07Apr2021 at 08:30 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history included blood pressure high, insect bite allergy, allergy to sweet corn and lactose sensitive since an unspecified date. Concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration in the left arm on 17Mar2021 at 08:30 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 08Apr2021, the patient experienced headache, muscle aches, fatigue and swollen lymph nodes under arms. The events did not result in doctor or other healthcare professional office/clinic visit/ emergency visit. No therapeutic measures were not taken as a result of reported events. The clinical outcome of the events headache, muscle aches, fatigue and swollen lymph nodes under arms was resolved on an unknown date in Apr2021.  No follow-up attempts are needed. No further information is expected.
Menstrual Cycle started today just 4 days after my last cycle finished.  Came again very heavy and early (next cycle shouldn't be until 6/30)
Swelling, redness, rash, pain (throbbing) especially when using arm. Contacted physician asked to take BENADRYL.
After receiving flu vaccination, patient fell on the floor without losing consciousness. When we (Rph & father) rushed over, pt was alert, he stated he felt weak, lightheaded, nausea. I let him lay flat on the floor until paramedic showed up. According to father, patient felt weak because he didn't eat have lunch. His vital sign is 106/70 and pt. refused to go to the hospital.
Within 10 min of vaccine administration, pt developed limp spell with pallor. Good HR and O2 Sat. Color and responsiveness improved quickly. Pt developed fever up to 101.4 x 48 hrs after vaccine.
Around 11pm on March 30th I noticed my right arm started to itch around the injection site and there was red raised skin (around 2-4 inches in width). These symptoms went away around two days later. In terms of treatment: Didn?t apply any lotions/ointment but did take a warm shower on the 31st to help with the itching.
I had my period for 2 straight weeks. Which was 2 weeks early. I?ve been taking birth control for over 10 years and my periods have never been early or late. And I ended up having my period 2 weeks early PLUS during the sugar pills when my period is SUPPOSED to come.   I have also experienced digestion issues since the vaccine that have not corrected.
She was tested for antibodies and the result was negative; This is a spontaneous report from a contactable consumer (patient). A female patient of unspecified age received bnt162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), first dose, via an unspecified route of administration, on unspecified date (lot number not reported) at a single dose; then the second dose, via an unspecified route of administration, on 25Jan2021 (lot number not reported) at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient received both doses of the Pfizer-BioNTech Covid-19 vaccine (second dose 25Jan2021). She was tested for antibodies and the result was negative (SARS-CoV-2 serology covid-19). She would like to know if we have any information on this topic, why her test was negative. The patient did the covid antibody test on 01Mar2021 with result of negative. Her doctor recommended her to receive a booster, she would like to know if there are any recommendations on receiving a booster shot. As of 25Jan2021 she had received 2 doses of the Covid 19 vaccine. On Monday of this week 01Mar2021, her regular doctor did blood tests. She got results on Tuesday, 02Mar2021. She had the Covid antibody test and she doesn't understand, she had thought that the blood test would show positive for Covid antibodies. The antibody test was negative. Now she is worried, and asked "did the vaccine not work?" She had called her doctor and she was told to get a booster and she doesn't even know if that's a thing or where you can get a booster. She doesn't understand what this antibody test is supposed to show.  She had a Covid antibody test done in May2020 and it showed negative and that was what she expected. She didn't have the Covid 19 vaccine and she didn't have Covid. She asked, "How can it show the same thing after receiving the Covid Vaccine?" Outcome of the event was unknown.  Information on the lot/batch number has been requested.
My asthma has been SIGNIFICANTLY worse since receiving the vaccine, there has been no other changes in anything else in my environment or life that would account for this. I do not believe it?s a coincidence, it has not gotten better.
4/23/2021 @ 6pm, ten days after Covid-19 Pfizer dose administered, patient said is had "floater and spiderweb in his vision and was blind in right eye within 30 min of symptom onset".  He went to ER and was told his eye was filled with blood and was referred to eye specialist who said blood vessels ruptured, probably due to increased eye pressure.  Patient has surgery scheduled 5/4/2021 to correct.
My mom had a stroke with in a month or two after getting vaccine.; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer reported for a female patient (reporters mother) of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number and Expiration date was not reported) via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that, reporters mother had a stroke within a month or two after getting vaccine on an unspecified date. She was fine now and the doctors found no indication of legs or other area throwing off clot. Reporter's friend's brother had same issue. Reporter was suggesting to make inquiry on both cases. She told anyone can contact to her she would be trying to help. The outcome of event was recovered on an unspecified date.  The lot number for the vaccine, (BNT162B2), was not provided and will be requested during follow up.
Woke up day after vaccine with trouble breathing; shortness of breath. Tried old inhaler, allergy tablet and deep breathing. Nothing helped but sleep. Felt light headed and faint, and only resting helped.  Felt less gasping for breath in the evening, went to bed early, and awoke today/Sunday with the same gasping of breath, feeling weak, light headed and unable to breathe properly.
Very severe arm pain a couple of hours after shot. Severe for 2 days then gradually diminished. On 9th day got round itchy rash at site of injection and shoulder pain. Had severe fatigue for 2 days after shot and am still experiencing ongoing unusual fatigue. Mild headache ongoing for 10 days.
No adverse effect reported; the patient received "less than a full recommended dose ofGARDASIL 9 because of needle leakage".; The medical assistant reports that is was not a manufacturer syringe, it was a plastic syringe used to withdraw vaccine from vial; This spontaneous report was received from a medical assistant, concerning a patient of unknown age and gender. Information about pertinent medical history, concomitant medication and drug reactions or allergies was not reported.  On 07-AUG-2019, the patient received less than a full recommended dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (lot # N023828, expiration date: 25-JUN-2020, indication: prophylaxis; dose and route were not reported) because of needle leakage. The medical assistant reported that was not a manufacturer syringe, it was a plastic syringe used to withdraw vaccine from vial (Wrong technique in product usage process). No adverse effect reported.
muscle aches; tiredness; chills that progressed to shaking; awoke in the middle of the night with profuse sweating; flu-like symptoms; cold; shaking; chills; fatigue; muscle aches; sweating; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu-like symptoms), NASOPHARYNGITIS (cold), TREMOR (shaking), CHILLS (chills) and FATIGUE (fatigue) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032120A and 033M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included MULTI VITAMIN [ASCORBIC ACID;COLECALCIFEROL;NICOTINAMIDE;PANTHENOL;PYRIDOXINE HYDROCHLORIDE;RETINOL PALMITATE;RIBOFLAVIN;THIAMINE HYDROCHLORIDE;TOCOPHERYL ACETATE], FEXOFENADINE, LEVOTHYROXINE and ATORVASTATIN for an unknown indication.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu-like symptoms), NASOPHARYNGITIS (cold), TREMOR (shaking), CHILLS (chills), FATIGUE (fatigue), the first episode of MYALGIA (muscle aches) and HYPERHIDROSIS (sweating). On 18-Jul-2021, the patient experienced the second episode of MYALGIA (muscle aches), FATIGUE (tiredness), TREMOR (chills that progressed to shaking) and HYPERHIDROSIS (awoke in the middle of the night with profuse sweating). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] at a dose of 2 UNK. On 28-Feb-2021, INFLUENZA LIKE ILLNESS (flu-like symptoms), NASOPHARYNGITIS (cold), TREMOR (shaking), CHILLS (chills), FATIGUE (fatigue) and HYPERHIDROSIS (sweating) had resolved. On 19-Jul-2021, last episode of MYALGIA (muscle aches), FATIGUE (tiredness), TREMOR (chills that progressed to shaking) and HYPERHIDROSIS (awoke in the middle of the night with profuse sweating) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: inconclusive (Inconclusive) The patient was waiting for the results..         Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.
4 inch x 2 inch red, hot, hard and tender area to the left thigh, antibiotics were ordered for 10 days.
Patient stayed for 15 minutes observation and was stable, patient left the vaccination clinic. Patient immediately came back to the observation area and reported that her feet were tingling. Patient was placed in triage and vitals were taken b/p 150/80, HR 106, R 18, 02% 98. Patient reported feeling shaky and weak. Patient was encouraged to take some deep breaths and try and relax.  Observation nurse asked if patient had eaten breakfast, patient admitted the did not. Patient given apple juice and a banana to eat. Patient was asked if she has any history of anxiety or panic attacks and she stated she did, but did not take any medication for it. Patient repeated that she felt weak and was having trouble holding the phone as she called her husband. Patient reported her husband was going to pick her up  to take her to a doctor but he was an hour and a half away.  This writer asked patient if she was going to go to the ER or go to her regular PCP,  patient reported she wanted to go to the Emergency Room. This writer advised that the patient should not wait that long and it would be best if this writer called the Emergency number for the campus, patient agreed. Emergency services were called and arrived within 5 minutes. Patient was able to walk with them to the ambulance.
Information has been received from a physician, via a company representative, concerning a 17 year old female patient, who on an unknown date was vaccinated with the first dose of Gardasil.  Concomitant therapy at the visit included MENACTRA and ADACEL.  The physician stated that the patient passed out twice after receiving the Gardasil.  She first passed out in the exam room, and then 10 minutes later she passed out again as she was walking to the bathroom.  The patient's systolic blood pressure was recorded as 60mmHg, and the staff "could not get a reading for the bottom number."  The staff called 911, and the patient was taken to the emergency room, where she was tested and released on the same day.  At the time of this report, the patient had recovered from the events.  Additional information has been requested. This is in follow-up to reports: previously submitted on 9/17/2007. Initial and follow up information has been received from a physician and a registered nurse, concerning a 17 year old female student, with no pertinent medical conditions, who on 10-JUL-2007, at approximately 10:30 am, was vaccinated IM in the arm with the first dose of GARDASIL (lot #655165/1425F). Concomitant vaccine therapy at the visit included the first dose, IM in the arm, of MENACTRA (lot #V2062AA) and the first dose, IM in the arm, of ADACEL (lot #AC524P12AA). There was no illness at the time of vaccination. The physician stated that the patient passed out twice after receiving the GARDASIL vaccine. She first passed out in the exam room, and was laid down for a few minutes. Then 10 minutes later, after she got up, she passed again as she was walking to the bathroom. The patient's systolic blood pressure was recorded as 60 mmHg and the staff "could not get a reading for the bottom number." The staff called 911 and the patient was taken to the emergency room, where she was treated and released on the same day, 30-JUL-2007, and had recovered from the events. Additional information is not expected.