chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pain that went down my leg to my foot, feeling it going down my thighs and knees; Sleepy; I have lack of appetite, lost 17 pounds; I have lack of appetite, lost 17 pounds; Tired; Started with one side of the hip then both; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Pain that went down my leg to my foot, feeling it going down my thighs and knees), SOMNOLENCE (Sleepy), DECREASED APPETITE (I have lack of appetite, lost 17 pounds), WEIGHT DECREASED (I have lack of appetite, lost 17 pounds) and FATIGUE (Tired) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced PAIN IN EXTREMITY (Pain that went down my leg to my foot, feeling it going down my thighs and knees), SOMNOLENCE (Sleepy), DECREASED APPETITE (I have lack of appetite, lost 17 pounds), WEIGHT DECREASED (I have lack of appetite, lost 17 pounds), FATIGUE (Tired) and ARTHRALGIA (Started with one side of the hip then both). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and GABAPENTIN at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Pain that went down my leg to my foot, feeling it going down my thighs and knees), SOMNOLENCE (Sleepy), DECREASED APPETITE (I have lack of appetite, lost 17 pounds), WEIGHT DECREASED (I have lack of appetite, lost 17 pounds), FATIGUE (Tired) and ARTHRALGIA (Started with one side of the hip then both) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
I had the first 2 shots and then hand trembling started in May of 2021.  I was diagnosed with giant cell arteritis (GCA) in June of 2021.
way worse without the shots I have noticed/suspected vaccination failure; way worse without the shots I have noticed; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 11-MAY-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient reported it would have way worse without the shots, he/she had noticed. Additional Supportive Information: This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. Follow-up could not be possible as no contact details were available.
Patient presented to ED on 4/14/2021 with 24 h of progressive painful/pruritic palpable purpura of distal upper and lower extremities.  No evidence of additional organ involvement.
mixed the Hiberix with Sterile Water; This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Hib (Hiberix) for prophylaxis.   On an unknown date, the patient received Hiberix. On an unknown date, unknown after receiving Hiberix, the patient experienced wrong solution used in drug reconstitution. On an unknown date, the outcome of the wrong solution used in drug reconstitution was unknown.       Additional Information: GSK Receipt Date: 21-SEP-2022 Reporter's Comments: Clinic administrator reported the adverse event via web form. Reporter stated that his/her team member inadvertently mixed the Hiberix with sterile water vs. the provided 0.9 percent Sodium Chloride. Reporter needed to verify if this dose needs to be repeated since it was not mixed appropriately. No further details provided. Additional supportive information: Inadvertently mixed the Hiberix with sterile water vs. the provided 0.9 percent Sodium Chloride, which led to wrong solution used in drug reconstitution.
Following the second vaccine dose, I had two highly unusual periods that were marked by 2 days of heavy bleeding. The bleeding was so heavy I soaked through 6-8 pads during a 5 hour time frame.  The bleeding also contained huge clots often the size of a golf ball or larger. This has happened on 6/4/21-6/6/21 and 7/2/21-7/4/21.  I recently went to my  provider on 6/25/21 for a gynecology exam and received normal results for cervica.
obese; high risk for cancer; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 70-year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: OBESITY (non-serious), outcome "unknown", described as "obese"; CANCER GENE CARRIER (non-serious), outcome "unknown", described as "high risk for cancer".  Additional information: Reporter reported she is obese and is high risk for cancer. Had both doses of the Pfizer Covid 19 vaccines. Now inquiring to coordinate to receive the booster dose because she needs to set an appointment for an xray and mammogram.    Follow-up: This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Flu-like symptoms; This case was reported by a consumer and described the occurrence of influenza-like symptoms in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On 12th September 2019, less than 2 months 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 setails were provided as follows: The age at vaccination was not reported. The reporter reported for his wife. The reporter reported that, the patient received dose of Shingrix 5 weeks ago and on the date of reporting had flu like symptoms.
I developed shingles on my face included nerve pain.; I developed shingles on my face included nerve pain.; This is a spontaneous report from a contactable other HCP (patient). A 25-year-old non-pregnant female patient received first dose of BNT162B2 (BNT162B2, Solution for injection, Lot number: EN6207), via unspecified route of administration, administered in left arm on 01Apr2021 at 15:15 AM at the age of 25 years as single dose for Covid-19 immunization. The patient's medical history included COVID-19. The patient had no other medical or allergic history. Concomitant medications included Aripiprazole (ABILIFY) and Venlafaxine hydrochloride (EFFEXOR). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination the patient was diagnosed with COVID-19. The facility of vaccination was workplace clinic. On 13Apr2021 the patient developed shingles on face including nerve pain. Adverse event resulted in doctor or other healthcare professional office/clinic visit. The patient received treatment for the events which included Valacyclovir. The patient had been tested for COVID-19 since the vaccination. On 14Apr2021 the patient had COVID test via nasal swab and the result was negative. Outcome of the events was recovering.   Information on lot/batch number was available. Additional information has been requested.; Sender's Comments: Based on known drug safety profile and temporal relationship there is reasonable possibility of causal association between the reported events Neuralgia and Herpes Zoster and the suspect drug BNT162B2.
12/01/2021: Employee slept from 8am-4pm. Had fever of 101.5*F, chills, nausea, body aches, and headache.
0847 patient, looked pale, stated do not feel good, passed out in chair, did not fall. Called MET.  syncope for 30 seconds.  When awake slightly confused but reoriently easily.  Unable to get a blood pressure.  Diaphoretic and pale.  METS placed patient on stretcher, BP 107/53 at 0855.  Transported to ED.
severe headache; nausea; pain in the upper jaw/teeth; pain in the upper jaw/teeth; almost like abscess tooth or something; became very, very sensitive; This is a spontaneous report from a Pfizer-sponsored program COVAX Support. A contactable male consumer (patient) reported for himself. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 10Feb2021 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient reported that after his first dose, the patient experienced severe headache, nausea and pain in the upper jaw/teeth on an unspecified date. The patient also stated that he had Pneumonia shot a long time ago. Patient stated that he experienced real bad headache. Nausea with the first one because he did not eat for several hours. Teeth was sort of hurting bad, almost like abscess tooth or something, became very, very sensitive so as he could not drink anything. He stated did not have severe nausea but had severe headache. Headaches are not as bad but teeth are still real bad, can hardly drink anything cool and not anything hot. The patient reports the things that were happening with me because they said they wanted to let them know. I have had both injections now. I have had the same problem with first one, but I wasn't positive, you know, it was just the injection which now I am. The problems are real bad headache, I had nausea with the first one because I didn't eat for several hours later which I did not do this time when I ate right away, I didn't have severe nausea, but I've had severe headache all that day, still some present today of it. By, I would say 8 o' clock, I don't know exactly what time, but my teeth were sort of hurting bad almost like you would have like abscess tooth or something and they became very, very sensitive so as I couldn't drink anything. But only the upper jaw teeth, both sides, but only in the upper jaw, nothing on the bottom and the head hurt. And the headaches are not as bad now, but these teeth are still really bad. And I can hardly drink anything cool and on the other side not anything hot. And what I wanted to ask is there anything that we can do about. The outcome of headache was recovering, for nausea, pain in the upper jaw/teeth outcome was unknown, pain in the upper jaw/teeth(toothache), almost like abscess tooth or something and became very, very sensitive was not recovered  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Person had syncopal episode after vaccination when standing to walk to observation area.  Paramedic on staff aided them to ground. Head protected. No reported med history on screening.   EMS called and on scene, person had full LOC when EMS arrived.  moved to unit and transported to hospital for further eval.
Headache and body pain beginning following morning, progressive throughout day adding chills/sweats by 2pm which resolved by about 10 pm. Residual minor headache next day
This spontaneous report was received from a public health practitioner referring to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with doses of M-M-R II (dose, route, anatomical location, lot number and expiration date were not provided), for prophylaxis. It was reported that in August 2016, an outbreak of mumps began (many of the people are children). Since then, there had been nearly 3000 cases of the disease across 33 counties in the state.  The reporter stated that M-M-R II was given in two doses, but, even with both doses, the vaccine was imperfect. Additionally, the reporter's study indicated that MMR vaccination in communities affected by the 2016 mumps outbreak was suboptimal. It was reported that one out of every 10 individuals who received the M-M-R II, remained susceptible to the mumps virus. In addition, in the event of a mumps outbreak, some people who got sick would be people who were vaccinated. It was reported that the average two dose vaccination rate in communities affected by the outbreak was likely no higher than 89% and might have been as low as 70%. At the time of reporting, the outcome of the vaccination failure and the mumps, and the causal relationship between the events with the M-M-R II, were not reported. Additional information has been requested.
Patient has received two flu shots within 2 days apart. Followed up with the patient 1 week after her second flu shot dose and she has NO adverse effect and did not have any adverse effect right afterwards as well.
TINGLING IN LEGS; CHILLS; FEVER; HEADACHE; LOWER LEG PAIN; This spontaneous report received from a patient concerned a 50 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 12-APR-2021 09:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 12-APR-2021, the subject experienced lower leg pain. Laboratory data included: Fever (NR: not provided) 101. Treatment medications included: ibuprofen. On 12-APR-2021 15:30, the subject experienced chills. On 12-APR-2021 15:30, the subject experienced fever. On 12-APR-2021 15:30, the subject experienced headache. On 13-APR-2021, Laboratory data included: DVT (NR: not provided) 1.46 H. On 14-APR-2021, the subject experienced tingling in legs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and fever on 13-APR-2021, was recovering from lower leg pain, and had not recovered from headache, and tingling in legs. This report was non-serious.
contracted COVID after first dose; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (contracted COVID after first dose) 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 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, the patient experienced COVID-19 (contracted COVID after first dose). At the time of the report, COVID-19 (contracted COVID after first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported by the reporter. No treatment medication was reported by the reporter.  Company comment: This spontaneous case concerns a female patient of an unknown age with no details on medical history, who experienced the unexpected non serious event/AESI of COVID-19 after mRNA- 1273 Moderna vaccine. The event occurred approximately 22 days after the first dose of mRNA- 1273 vaccine. Very limited information is available regarding symptoms and clinical course. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a female patient of an unknown age with no details on medical history, who experienced the unexpected non serious event/AESI of COVID-19 after mRNA- 1273 Moderna vaccine. The event occurred approximately 22 days after the first dose of mRNA- 1273 vaccine. Very limited information is available regarding symptoms and clinical course. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.
This spontaneous report was received from a Healthcare worker concerning approximately a 4 year old female patient. The patient's medical history included anemia and gastrointestinal reflux disease. The patient had no drug reactions/allergies. On 07-AUG-2014 the patient was vaccinated with M-M-R II, lot # K002527, expiry date: 18-FEB-20166, 0.5 ml, once, subcutaneously. No concomitant therapy was reported. On 16-AUG-2014, the patient developed a rash on her arm, acting very agitated, fever of 103.5 and swollen glands and. The outcome of fever of 103.5 acting very agitated, swollen glands and developed a rash on her arm is unknown. No laboratory diagnostic tests were done. The patient sought medical attention. No intervention initiated to prevent serious criteria as there were none. On 16-AUG-2014, the patient was seen in the Urgent Care and saw physician on 19-AUG-2014. The Urgent Care physician ordered Cefdinir and Mupirocin to treat the symptoms. No product quality complaint was filed. The action taken was assessed as not applicable. The outcome and causality were not reported. Additional information has been requested.
Patient presents to Urgent Care for evaluation of a vaccine reaction.  He went to his primary care physician, for a Prevnar 23 vaccine on Monday, May 10 at approximately 10 AM.  He reports having a Prevnar vaccine in 2019 without any problem.  He has not had any other vaccines within the last 2 weeks and has never had a COVID-19 vaccination.  He admits that they did hold pressure at the injection site since he is on a blood thinner and he has not appreciated any swelling at the injection site or bleeding. Later that evening at 7:30-8:00 pm he developed chills, rigors, arm swelling at the injection site and a oral temperature of 99.7.  He took Tylenol and went to bed with some improvement in his symptoms.  Since then his arm has become red, swollen extending downward from the injection site.  It did have some itch to it but now it has become more circumferential and painful causing him to seek evaluation.  His pain is aggravated by palpation and the symptoms were improved with Tylenol originally but continued to worsen now.  He is on Tikosyn and Eliquis so he is unsure of what he can take for his symptoms.  His symptoms are moderate in severity, rapidly worsening and persistent in nature. On physical exam he has 16 x 27 cm erythema and warmth with pain to palpation distally to the  injection site that is well appearing without hematoma, erythema or pain.  Erythema is almost circumferential in nature and arm measures 32 cm at the time of exam. Neurovascularly intact with compartments soft.
Sometime in January but more pronounced in February I developed what I believe is Peyronie's Disease. My penis has always been completely straight with no curve. After the first dose I noticed a slight upward curvature which after the second dose has become quite noticeable and not pronounced. I'm 66 years old and I have never had even an inkling of this symptom. I can't imagine what else it could be other than that it happened after the first dose and became more pronounced after the second dose.
4-28-05 Client states she developed fever 101 F. 5-7-05 Client states she developed itchy rash from the neck down.
A couple of days after the injection I had  a rash below the area of the shot. The rash was 4 inches by 2.5 inches and itches. Now at day 12 I still have a faint rash with itching.  I also had a fever (100.1) and body aches for the first 2 days. Then later began coughing and still have the cough. I am not sure if the cough is related to the vaccine or if it may be a virus that I may have picked up. I have been treating the symptoms using OTC cough syrup, Tesslon Pearls and albuterol inhaler if I get wheezy.
The patient presented with a rash on her neck and chest after 30min of administration of the vaccine. The patient denied difficulty swallowing or breathing. patient also denied itching and tightness in the throat and chest. No edema of the face or tongue was noted. The patient was administered 25mg diphenhydramine orally. 10 minutes after administration the rash had subsided. Patient was monitored for 20 additional minutes. Symptoms did not return. Patient was given an additional 25mg diphenhydramine tablet in the event the rash did return.
Patient reports mottled skin around midsection of abdomen going around to back and burning sensation starting more recently.
Headache, fatigue, cough, fever, chills, nausea, vomiting, loss of appetite.
Pt. states that after receiving the 1st dose of Phizer 0730/2021, started to experience a headache, body pain, feet swelling, bump located at the injection site, and tenderness. No noted Primary visit, still continuing experiencing symptoms.
3 hours after getting the vaccine my arm started itching and I got some hives in my arm, then in my mouth, then my whole face. By 9 pm my whole body was covered in hives. I started getting worried because this has never happened to me before. I used some cream to see if that could help with the itching. 2 days after I went to the ER because I could not tolerate the itching anymore. I told them that this started after getting the vaccine and they told me that they were not sure if it was a reaction to the vaccine. They just gave me Benadryl and told me to come back if I still was having hives. I was still having itching all over my body. Like 4 days after I went back to the ER because I could not take the itching anymore. They gave me Bendaryl in injection. They still were not sure if it was a reaction to the vaccine. I asked if it was safe for me to take the second dose and they said yes. I explained them that my symptoms started when I got the first dose and they still told me to take the second dose. When I had the second dose I explained to the staff what happened after getting the first dose and they said they would keep an eye on me. Nothing happened so I left. I went to see my doctor for a regular check up and I told them about my situation and they told me to not take the second dose because it looked like I was having an allergic reaction to the vaccine. I told them I had already received the second dose and they just told me to keep an eye on it and to go to the ER if I started getting hives again. Like 3 hours later the itching started again. I started getting hives again in my mouth, then my face, and then all over my body. The next day I woke up all swollen. I went to the hospital again and they told me it was an allergic reaction to the vaccine. They injected me Benadryl. The next day I went back to the hospital because the symptoms came back and I told them they were stronger after the second dose. They said they did not know if this was an allergic reaction to the vaccine because they had already been 48 hours since I got the vaccine. They told me to keep taking Benadryl and use a cream. I still have itching and hives but I do not want to go to the hospital anymore because I spent a lot of money in there.
Diarrhea for 10 days following, took Imodium as needed, repeated... Very painful breast for two+ weeks following. Especially over treatment areas. Took Aleve, Tylenol or like to help some., this was in week 2, 3,4.
Moderna Covid19 vaccine administered to underage patient. No adverse event experienced on follow-up with patient