chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Treatment of COVID-19/ Covid rebounded. After taking Paxlovid, 1 week to day of finishing the treatment; Treatment of COVID-19/ Covid rebounded. After taking Paxlovid, 1 week to day of finishing the treatment; I have been symptomatic and quite sick for 6 days; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from PAXAES. The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Feb2021 as dose 1, single (Lot number: EN6201), in left arm, on 19Mar2021 as dose 2, single (Lot number: ER2913), in right arm and on 17Dec2021 as dose 3 (booster), single (Lot number: FL3197) at the age of 46 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: ILLNESS (non-serious) with onset 02May2022, outcome "not recovered", described as "I have been symptomatic and quite sick for 6 days"; DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19/ Covid rebounded. After taking Paxlovid, 1 week to day of finishing the treatment". Therapeutic measures were taken as a result of covid-19. Therapeutic measures were not taken as a result of illness.  Clinical information: Current age of patient was 47 Years (as reported). If vaccine received: Yes. Other medication in 2 weeks: No. Patient had no known allergies. Adverse event: After taking Paxlovid, 1 week to day of finishing the treatment, Covid rebounded. I have been symptomatic and quite sick for 6 days. AE resulted in: [None of the above].  No follow-up attempts are possible. No further information is expected.
Patient received duplicate 2nd booster. Patient reported he needed the second booster but after administration, his son called the vaccine clinic and told them the patient received the second booster at another site.
Vaccinated with Pfizer 2/1/21 and 2/22/21.  Symptom onset 6/8/21 with cough, runny nose and nasal congestion - mild cold symptoms.  Sample sent for genomic sequencing.
This case was reported by a pharmacist via call center representative and described the occurrence of influenza-like symptoms in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was unknown. It was unknown if the reporter considered the influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The health care professional requested Safety Department reach out to her to obtain details about the patient and their experience. The health care professional did not have time to stay on call. This case has been linked with case US2018GSK184102, reported by the same reporter.
As soon as withdrawing the needle from arm the area around the site began swelling and turning red. Applied ice to site and patient took BENADRYL at home. Area stayed red & swollen for 5 days. Still has a knot at injection site small dry rash and less redness.
BITTER TASTE ON MOUTH (CHEMICAL TASTE); AN INTERMITTENT SENSE OF CHEMICAL SMELL; FEVER; This spontaneous report received from a patient concerned a 31 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 03-APR-2021 on left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 03-APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 102 F. On 05-APR-2021, the subject experienced bitter taste on mouth (chemical taste). On 05-APR-2021, the subject experienced an intermittent sense of chemical smell. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever, and had not recovered from bitter taste on mouth (chemical taste), and an intermittent sense of chemical smell. This report was non-serious.
Received MCV4, Hep.A, Varicella on 01/20/2009.  On 01/21/2009 her lower L. arm (just above the elbow) became swollen, red, very sore and warm to touch.  She started using Motrin 1 q 6-8Hours.  She put a cold compress on it.  On 01/22/09, she continued with the same s/s.  Father called Health Dept. and talked to RN.  When RN checked patient's record, she told father that is the area where she got the Varicella vaccine.  No swelling or problems with the other 2 sites.  RN instructed to apply ice for 20 minutes q hour, try taking some Motrin and Benadryl(don't drive afteer taking Benadryl!)  Instructed to call private provider or go to ER. if arm worsens or does not continue to improve.  On 01/23/2009 RN returned a call to family to see how she was doing.  She said that her arm is still slightly warm to touch but no redness or aching.  Encouraged her to continue with the Benadryl and Motrin, both prn.  See her PP if worsens.
Severe abdominal pain. It was like muscle spasms that came in waves starting about 2 1/2 hours after receiving the vaccine. This pain had me doubled over and caused me to feel weak like I might pass out. The first couple of hours the waves came within 3-5 minutes of each other. Called the pharmacist and he thought it might be an allergic  reaction and advised that I go to the ER. The ER had a very long wait. After about another 30-45 minutes I noticed more time between waves of spasms. After being in the ER for about an hour and a half I noticed I was feeling better and was able to have a bowel movement. Not looking forward to a 3 or more hour wait in the ER I went home without treatment. I had a couple of episodes of watery diarrhea within a few minutes of arriving at home and for the rest of the evening I felt better and the spasms stopped. The whole event was about 4-5 hours in duration.
Initial and follow up information has been received from a licensed practical nurse concerning a 16 year old female with a penicillin allergy and no pertinent medical history who on 22-APR-1996 was vaccinated SC in the left triceps with a 0.5 ml first dose of varicella virus vaccine live (Oka/Merck). On 18-SEP-2007 the patient received SC in the left arm a second booster dose of varicella virus vaccine live (Oka/Merck) (Lot#658197/0853U). Concomitant vaccines included a second dose of MSD vaccine (yeast) (Lot#658560/1062U) given in the right arm, and a dose of MENACTRA vaccine (dip toxoid) (Lot#U2402AAA) also given in the left arm. On 19-SEP-2007 the patient developed a swollen and red arm. The nurse told the mother to apply a warm compress, look for any red lines, or fever, and to let the office know if the patient's arm did not improve. No lab studies were performed. On 20-SEP-2007 the mother called and said the arm was worse. The nurse instructed her to continue with the warm compresses. The nurse made a follow up call to the mother on 21-SEP-2007 and the arm continued to be reddened, but the swelling was less. On an unspecified date the patient recovered. No further information was provided. There was no product quality complaint involved. Additional information has been requested.
Hands are super itchy. Like distractingly itchy.; They are also warmer to the touch; Slightly redder; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 02Apr2021 at 19:00 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to penicillin. The patient did not receive any concomitant medications. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. On an unknown date post vaccination, the patient underwent nasal swab and tested negative. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 03Apr2021 at 06:00, the patient experienced hands were super itchy, like distractingly itchy. The patient had never experienced this type of sensation in life. They were also warmer to the touch and slightly redder. the patient assumed it would just kinda go away but it really hadn't and it got the patient slightly worried about the second dose. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the event hands were super itchy, warmer to touch and slightly redder was not recovered at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
She lost control of her legs and fell also losing control of bowel and bladder function 3 days after the vaccine.  After this, she constantly felt there was something in her intestines she couldn?t get out.  Finally got her a colonoscopy within the same medical group.  He found and removed 9 polyps - she had never had any before when colonoscopies had been done in the past,  she had blood pressure spikes frequently and never had them before the vaccine - even at 9 months pregnant twice.  Ultimately her hiatal hernia became symptomatic, strangled by the wrappings and had her stomach removed.  Died 6 weeks later 3/12/2022.
Rebound symptoms of covid on day 16 from first positive test and 10 days after completing paxlovid.  Symptoms of side affects from ritonivir 18 days after completing 5 day dose; Rebound symptoms of covid on day 16 from first positive test and 10 days after completing paxlovid.  Symptoms of side affects from ritonivir 18 days after completing 5 day dose; This is a spontaneous report received from a non-contactable reporter(s) (Physician). The reporter is the patient.  A 43-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Dec2020 as dose 1, single (Batch/Lot number: unknown), in left arm, on 15Jan2021 as dose 2, single (Batch/Lot number: unknown) and on 27Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 43 years, in left arm for covid-19 immunisation. No known allergies.The patient's relevant medical history included: "environmental allergies" (unspecified if ongoing); "Elevated lipoprotein a" (unspecified if ongoing), notes: Other medical history: Elevated lipoprotein a and environmental allergies. Concomitant medication(s) included: FLONASE [FLUTICASONE PROPIONATE]; SINGULAIR; MAGNESIUM; B12 [CYANOCOBALAMIN]; ALLEGRA. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 19Apr2022, outcome "unknown" and all described as "Rebound symptoms of covid on day 16 from first positive test and 10 days after completing paxlovid.  Symptoms of side affects from ritonivir 18 days after completing 5 day dose". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (19Apr2022) Positive, notes: Rebound symptoms of covid on day 16 from first positive test and 10 days after completing Paxlovid; (05May2022) Positive, notes: Rebound symptoms of covid on day 16 from first positive test and 10 days after completing Paxlovid. Therapeutic measures were taken as a result of covid-19. Anti-viral details: product COVID 19 Treatment, Paxlovid, Treatment start date: 22Apr2022, Treatment stop date: 26Apr2022, Indication: Treatment of COVID-19. Adverse event: Rebound symptoms of covid on day 16 from first positive test and 10 days after completing paxlovid. Symptoms of side affects from ritonivir 18 days after completing 5 day dose. Adverse event country: (name). Adverse event start date: 07May2022. Ae resulted in: None of the above. If patient recovered: Not recovered. If treatment ae: Yes. Ae treatment: Omeprazole and Pepcid.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information available and close temporal association, a possible contributory role of the suspect Product cannot be excluded for the reported events . The case will be reassessed once new information is available.
Shingles; This is a spontaneous report from a contactable consumer. This consumer reported similar events for three patients (Herself and Two Other Patients). This is 1st of 3 reports. This report for a 47-year-old female patient (Reporter Herself). A 47-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number - Er2613 and expiration date was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 01Apr2021 17:00 (at the age of 47-years-old) as a single dose for covid-19 immunization. Medical history included drug hypersensitivity- Penicillin. There were no concomitant medications. On 10Apr2021, the patient got shingles in the same arm as the vaccine 9 days later. She happen to know two other people who also got shingles after their vaccine. It could be a coincidence but thought it was worth reporting for your tracking purposes. AE resulted in doctor or other healthcare professional office/clinic visit. The patient was received treatment with anti-viral medication. Outcome of the event was recovering. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : PFIZER INC-2021433882 same reporter/AE/drug, different patient;-PFIZER INC-2021433881 same reporter/AE/drug, different patient
Pt recv vax on 10/13/98; 2.5 hr post vax pt exp confusion & disoriented; pt imp 24 hr
She got her vaccine, she was fine and then lost her taste and smell, and her muscles in her lower body became weak, everywhere, her stomach muscles are gone, she has a hard time sitting up in bed.  She sits on the couch all day and goes to bed at  night.  It also affected her legs and arms.  She lost about 30# in one month.  She was loosing 1-2# a day, and there was nothing that she could do.  She went to her doctor for something else, then went to his PA and she sent her to Dr.  They wanted to do blood work before doing a muscle biopsy.  She had gastric bypass 17 years ago, and had no problems, but since May/June of 2021 she suddenly lost 30#.  The blood work was normal and had nothing to do with the bypass, and he was a neurologist and refused to do the muscle biopsy.   She was then sent to another neurologist to find out if the muscles are atrophied or what.    She went to the ER at one point sitting in a wheelchair, checked her BP and did some lab work and said that it must be anxiety and sent her home.  Her arms do not work well enough to use a wheelchair, and still has no use of her arms or her legs.  She cannot pick up anything heavy, she cannot walk with any weight in one arm as she will tip over, and her mother has to help her.   She also has a hard time breathing, and gets out of breath easily.  She never had any of these symptoms prior the vaccine.
This spontaneous report was received from a healthcare worker regarding an unspecified number patients of unknown age and gender. The patients' medical history and concurrent conditions were not reported. On an unknown date, the patients were vaccinated with doses of VAQTA injection (dose, lot number, expiration date, route and anatomical location of administration were not reported), which were improperly stored. It was unknown if a digital data logger was involved. No adverse effects were reported and no product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
On 10/6/21 the next day, I dont remember anything. My daughter took a video of it. She was asking my name, and I didnt know anything, I was able to move, but I didnt know. She called the ambulance, and they asked what I took, but all she could find was medication in my purse, so they admitted me to the hospital stating that I accidentally overdose. So they gave me Narcan when I was here, gave me another shot in the ambulance. When I got to the hospital, the er doctor gave me another shot, and I went crazy. All of a sudden I dont remember anything. Then the next thing I remember, is the er doctor came in and said I overdose. He stated he didnt know what was wrong, cause no one told him, I had the covid shot. I dont remember saying things to the doctor. My grandaughter was beside me, and about 10 at night, they said they gave me some tylenol and narcan and sodium chloride. I didnt even know what hospital I was in. Around 10 I was heginning to come around to myself. They ran all kind of test, and couldnt find anything. When they told the doctor that I had the covid shot, he knew that's what it was.  Then the doctor stated he was sending me for a CTSCAN of the brain and also my breast on the left side was swollen and sore, and under my arm was swollen. They diagnose me with alternate mental status (Transient Alteration Awareness).
My left arm continues to have varying degrees of pain and discomfort. In addition, in order to avoid pain or discomfort, I have had limited mobility with my left arm.  I've required assistance putting on a shirt/jacket. Early on the pain was continuous, it is now intermittent. The pain is particularly acute when I twist my arm not necessarily related to lifting an object. I threw a piece of clothing over my left shoulder yesterday and the pain was immediate. Because of similar pain from the first shot of Shingrix, I spoke both with the pharmacist and my doctor about my reaction within 3 weeks of the second shot and neither seemed concerned.
Starting 6/2/21, pt felt like her kidneys "were not working properly." She states she isn't urinating much and when she does urinate, her arms tingle. Symptoms have persisted throughout yesterday and today 6/3/21.
Lip swelling about 5 hours after event. Resolved with single dose of antihistamine. No signs of respiratory difficulty, GI symptoms, urticaria, or other indications of allergic reaction.
Her throat is different, it's dry; She is starting to have a cough, not a heavy one, but a dry cough; This spontaneous case was reported by a consumer and describes the occurrence of DRY THROAT (Her throat is different, it's dry) and COUGH (She is starting to have a cough, not a heavy one, but a dry cough) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 059H21A, 041C21A and 026A21A) for COVID-19 vaccination.     Concurrent medical conditions included Deaf and Autism.   On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In December 2021, the patient experienced DRY THROAT (Her throat is different, it's dry) and COUGH (She is starting to have a cough, not a heavy one, but a dry cough). At the time of the report, DRY THROAT (Her throat is different, it's dry) and COUGH (She is starting to have a cough, not a heavy one, but a dry cough) outcome was unknown.            No concomitant product use was provided. No treatment medication was provided.
My arm was sore; Chills; Achiness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (My arm was sore), CHILLS (Chills) and MYALGIA (Achiness) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jan-2021, the patient experienced PAIN IN EXTREMITY (My arm was sore), CHILLS (Chills) and MYALGIA (Achiness). At the time of the report, PAIN IN EXTREMITY (My arm was sore), CHILLS (Chills) and MYALGIA (Achiness) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were reported.  No treatment information was reported.
This is a spontaneous report from a Pfizer-sponsored program. A contactable physician reported for a 65-year old female patient of an unspecified ethnicity started to receive bacitracin (UNKNOWN MANUFACTURER); NEOSPORIN; ibuprofen (UNKNOWN MANUFACTURER); Aspirin; BENADRYL; SUDAFED NON-DRYING SINUS; VERSED; and SENOKOT, all via unspecified routes of administration on unspecified dates at unknown doses for unspecified indications. The patient also received the following suspect vaccines: PREVNAR 13 and INFLUENZA VIRUS VACCINE, both were given via unknown routes of administration on unknown dates at a single dose for immunization. The patient's medical history included drug allergy to Cephalosporins. Concomitant medications were not reported. On unknown dates, the patient experienced allergies to Pneumococcal, Ibuprofen, Aspirin, Bacitracin, Influenza virus vaccine, SUDAFED Non Drying Sinus, NEOSPORIN, SENOKOT, VERSED, and BENADRYL. The action taken in response to the event for bacitracin was unknown; for gramicidin, neomycin sulfate, polymyxin b sulfate was unknown; for ibuprofen was unknown; for acetylsalicylic acid was unknown; for diphenhydramine hydrochloride was unknown; for guaifenesin, pseudoephedrine hydrochloride was unknown; for influenza vaccine was not applicable; for midazolam hydrochloride was unknown; for pneumococcal vaccine was not applicable; and for senna alexandrina was unknown. The clinical outcome for the event was unknown. Follow-up (26Apr2016): New information reported from the same contactable physician includes: Follow up attempts are completed. No further information is expected. Follow up (13Feb2017). New information reported from a contactable physician  included: patient' age. Follow-up attempts are completed. No further information is expected. Sender's Comments: Linked Report(s) : 2016197395 Legacy paper report number.
LIGHTHEAEDED, FEELING WOOZY  HEART RATE  140 -160   BP UP TO 150/80 EXPERIENCED SIMILAR WITH FIRST DOSE OF VACCINE.
GARDASIL vaccine and within a 2 week time frame from receiving each dose of the vaccine "patient" suffered extreme hi pain. The pain was so severe she couldn't walk. Still has hip pain - constant but not as severe. Follow-up Information 30-SEP-2008: I cannot give exact date or time. Events started within a week or 2 weeks after all 3 Gardasil shots.
Rash on buttocks and arms Heartburn Both more than two weeks. Had follow-up to heartburn to rule out cardiac event.
this is a booster, one time shot,  The stock vial was not diluted prior to drawing 0.2ml into the syringe for dispensing.  As of 10/21/22 the father has indicated there are no known side effects.
Hep B #1 7/24/03, Dose #2 9/16/03. 9/26/03 possible fever, malaise, fatigue, anorexia. 10/3/03 Icteric, and dark urine, 5 lb weight loss. Examined 10/6/03 (pt 1st reported sx 10/6/03) Icteric, no HSM, LLQ and discomfort, no RUQ pain. LA Lg biv LFT Thili 5.2, Attephos 307, AST 220, ART 631.
vaccination at approx 11:45 am, reaction hit approximately 5:00 pm - had to leave work due to reaction. fever, chills, aches and pains, sharp stomach pain, nausea, pain and difficulty breathing. Patient home and in bed at time of this report(7:50pm). consent forms lists immunization as "VIS 07/24/08"