chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Around 10/6 I developed a persistent cough that lasted for about four days. A low grade temperature developed and the cough got a little worse so on 10/10 I went to the Medical Center ER and a Chest X-ray, EKG and bloodwork was performed. It was thought I had an Upper Respiratory Infection, a COVID-19 test was done and I was released. I got a call later that day and confirmed I was positive for COVID-19 and after about four days of being down I begin feeling a little better and finally back to normal. I reached out to my PCP to see if there was any follow up was needed but was advised to quarantine for two weeks.
Patient complains of generalized urticara with tightness in chest.  Swelling of the tonsils was observed, however patient denied any prior illness.
About a week after the shot in my left arm, I started inching and my arm swelled up about a two to three inch circle under the place where the shot was given.  The skin underneath the shot area is hard to the touch.    Note:  I have also had shoulder replacement surgery on both of my shoulders within the last six years.
Hot red rash at injection site. Blotchy warm rash on whole body started the following evening. Treated with BENADRYL at home. Seen today 3-27 had slight red area at injection site.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Nov2021 as dose 3 (booster), single (Lot number: FF2590) at the age of 29 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Endometriosis" (unspecified if ongoing), notes: other medical history: Endometriosis; "Asthma" (unspecified if ongoing), notes: other medical history: Asthma; "Allergies" (unspecified if ongoing), notes: other medical history: Allergies; "known allergies: Cashews" (unspecified if ongoing), notes: known allergies Cashews and pistachios; "known allergies: pistachios" (unspecified if ongoing), notes: known allergies Cashews and pistachios. Concomitant medication(s) included: SUDAFED [PSEUDOEPHEDRINE HYDROCHLORIDE]; GUAIFENESIN; TYLENOL. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Positive Test on Day 11. Therapeutic measures were taken as a result of drug ineffective, covid-19. Covid-19 treatment was done with paxlovid.  Additional information: Covid-19 treatment was done with paxlovid from 08Jul2022 to 12Jul2022.
Patient felt like he may have had a slight fever the night before his passing. He laughed and played that night. 10 PM he ate oatmeal and banana. 12:00, he had a bottle and fell asleep. He awoke at 3:41 AM and had another bottle; played a little while, fell asleep. He began to scream so I picked him up and laid him on my chest. He slept there until 7:00 AM. I laid him on the bed while I got ready for work. He was asleep when I left for work at 8:10 AM. He was fine. His father checked on him and he was not breathing. Nurse follow up on 10/21/04 states: "unresponsive, bacterial infection, cyanosis, asystole." Autopsy Report received on 1/25/2005 states SIDS.
Severe 103 degrees F fever, joint pain 10/10, baseball size red site 3" x 3", hot to touch, muscle weakness. unable to get out of bed. 10/6/12 Pain 6/10. Went to PCP. CIPRO taken. All symptoms resolved.
UNABLE TO RISE UP ARM AS NORMAL; LEFT SHOULDER PAIN; INJECTION SITE SORENESS; This spontaneous report received from a patient concerned a 77 year old male. 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 not reported, batch number: UNKNOWN) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 11-MAR-2021, the subject experienced unable to rise up arm as normal. On 11-MAR-2021, the subject experienced left shoulder pain. On 11-MAR-2021, the subject experienced injection site soreness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from injection site soreness, left shoulder pain, and unable to rise up arm as normal. This report was non-serious.
developed side effect of granuloma post vaccination with Pfizer Covid-19 Vaccine; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: GRANULOMA (non-serious), outcome "unknown", described as "developed side effect of granuloma post vaccination with Pfizer Covid-19 Vaccine".  Additional information: Reporter wanted to know if Granuloma has been reported post vaccination. Reporter called on behalf of a patient who developed side effect of granuloma post vaccination with Pfizer Covid-19 Vaccine.  Lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Gout, right big toe, no risk factors for gout, continues after 2 months, pain is mild, greatest in the morning. NSAID helps. Not getting 2nd round of shot, for fear that symptoms could get worse.
Patient experienced dizziness, sickness feeling on the back of her tongue, and sharp pain. Patient is also taking Benadryl for headache treatment as prescribed by HCP.
shingles shot, got a severe case of shingles/ suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male 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-Jul-2022 Reporter's Comments:  This case was received from consumer via interactive digital media. The reporter was patient wife. The reporter and her husband paid for shingles shot and the husband got severe case of shingles. The reporter mentioned many people who have taken the expensive shot and later still got shingles. The shot was expensive and did not work. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation were unknown at the time of reporting. The follow-up could not be possible as no contact details were available. This case has been linked with the case US2022AMR105921 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR105921:same report, other patient
Sore throat; Cough; Sore arm; Headache; This spontaneous case was reported by an other health care professional and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat), COUGH (Cough), PAIN IN EXTREMITY (Sore arm) and HEADACHE (Headache) 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 an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced OROPHARYNGEAL PAIN (Sore throat), COUGH (Cough), PAIN IN EXTREMITY (Sore arm) and HEADACHE (Headache). At the time of the report, OROPHARYNGEAL PAIN (Sore throat) and COUGH (Cough) had not resolved and PAIN IN EXTREMITY (Sore arm) and HEADACHE (Headache) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was not reported No treatment medications were provided  Patient had a third shot on Monday and had sore arm, headache about 30 hrs and was fine.
Tingling in right pinky and wrist (pinky side, right arm); This is a spontaneous report from a non-contactable consumer, the patient. A 41-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0196) via an unspecified route of administration in the right arm on 09Aug2021 at 12:00 (at the age of 41-years-old), as a single dose for COVID-19 immunisation. Medical history included allergy to penicillin. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medication. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0217) via an unspecified route of administration in the left arm on 19Jul2021 at 15:00, as a single dose for COVID-19 immunisation. On 10Aug2021, the patient experienced tingling in right pinky and wrist (pinky side, right arm). Since the vaccination, the patient had not been tested for COVID-19. The event did not result in doctor or other healthcare professional office/clinic visit/ emergency visit. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event tingling in right pinky and wrist (pinky side, right arm) was not recovered at the time of this report.  No follow-up attempts are possible. No further information is expected.
Breakthrough COVID infection. Tested positive on 11/23/22 via a home test. Returned from a 10 day trip on 11/19/22.
at 02:45 client complained of tingling in L hand, flushed, hot, racing heart beat, nausea, headache  BP 179/98, P 61, O2 98% 3:00 BP 144/97, P-63, O2 98%,  3:11 BP 122/98, P-57, O2 98%, 3:22 headache, lower jaw pain increasing to upper jaw, 3:24  BP 160/102, 156/106, refused ambulance, 3:28 transported by daughter to ER.  Spoke with client the following day, client's BP went up to 284/224 while in the ER, client had arm heaviness from elbows down, shoulder blade pain, client was given metoprolol, pepcid, phenergan and steroids.  Client was released at 7 pm, client went home with daughter and had chest pain and headache all night.  client was doing better the next day, only complaining of headache off and on.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Mar2021 as dose 1, single (Lot number: Er8733), in left arm, on 17Apr2021 as dose 2, single (Lot number: Ew1062), in left arm and on 21Dec2021 as dose 4 (booster), single (Lot number: Fh8027) at the age of 55 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Past drug history included: Sulfa, reaction(s): "drug Allergy". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Indication=Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical Course: Patient did not received other medications in 2 weeks. Anti viral details, product=COVID 19 Treatment, brand=Pfizer. Treatment start date=31Oct2022 and treatment stop date=04Nov2022. Indication=Treatment of COVID-19.
Two days after injection patient started having vomiting, was vomiting every hour from 1am-6am. Was feeling fatigued and "grey" looking.
This spontaneous report was received from a registered nurse referring to an approximately 73 years old female patient. The patient had no pertinent medical history, no drug reactions/allergies. Concomitant medication was reported as none. On 16-APR-2018, the patient was vaccinated with PNEUMOVAX 23 (strength and dose were not reported) (lot # N019838 and expiry date: 16-FEB-2019) subcutaneously in the left arm to prevent pneumonia. On 16-APR-2018 (2 hours after receiving the vaccine), the patient developed Patient developed redness, warmth, tenderness, pain (pain in extremity), intense itching, and swelling from the elbow and half way up the injection site arm. It was reported that the patient was in the office on 18-APR-2018 for an unspecified reason unrelated to the PNEUMOVAX 23 and reported the symptoms. No treatment was provided for the adverse events. No lab diagnostics/studies performed. At this visit, the patient stated that she had the same reaction to PREVNAR 13 (Wyeth) "1 year ago." No further clarifying information was provided. The outcome of the events was reported as not recovered/not resolved. Causality was not reported for the adverse events redness, warmth, tenderness, pain (pain in extremity), intense itching, and swelling with PNEUMOVAX 23 vaccination. Additionally, the reporter stated that the adverse event not specified was not related to PNEUMOVAX 23 vaccination. No product quality complaint (PQC) was involved.
Tested positive for COVID-19 after being fully vaccinated; Tested positive for COVID-19 after being fully vaccinated; This is a spontaneous report from a contactable nurse. A 58-year-old male patient received BNT162b2 (PFIZER- BIONTECH COVID-19 mRNA VACCINE, Batch/Lot Number: EN5318), dose 1 intramuscular, administered in left arm on 26Jan2021 (at the age of 58 years) as a single dose, and dose 2 intramuscular, administered in the left arm on 17Feb2021 (Batch/Lot Number: EN5318) (at the age of 58 years) as a single dose for COVID-19 immunisation. The patient had no medical history and took no concomitant medications. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient tested positive for COVID-19 after being fully vaccinated. On 22Jul2021, PCR Nasal Swab was positive. The patient was seen by a doctor or other healthcare professional office/ clinic visit. The patient received no treatment. The outcome of tested positive for COVID-19 was recovered.; Sender's Comments: Based on the available information, the known safety profile and the temporal association of BNT162b2 administration to the events, a possible contribution of the drug to the events cannot be excluded.
pt recv vax 26JUL95 p/tx for laceration to lt index finger; returned to clinic on 24JUL95 c/o fever, nausea & cough;
About 15 minutes after the dose of Pfizer started to feel tingling and swelling of her lips. Stated it came and went but after another 10 minutes stated she thought her tongue was starting to swell in the front and then moved to the back....also, stated it came and went. Has had fillers in her lips so difficult to assess their size. No SOB,  sweating, hives, itching,  Dryness of throat improved with water. Evaluated by crisis nurse but Eppy never given Monitored for 1 hour with resolution of problems. BP 108/72 with pulse oxy of 97. Left clinic area accompanied by her physician husband and will call her allergist about further directives and whether or not she should get a second vaccine. Refused to be monitored in ED or go there for more evaluation.
Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medications were not provided. The patient was inoculated with ZOSTAVAX vaccine, for routine health maintenance and for the prevention of shingles. After receiving the vaccination, the patient suffered headaches, fatigue, generalized pain throughout her body and weakness. These symptoms intensified over time and culminated in her being hospitalized and ultimately diagnosed with meningitis. Thereafter, the patient suffered and continues to suffer from outbreaks of zoster rashes on her stomach and chest area, sudden sharp pains, headaches, fatigue and weakness. As a result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. As a direct and proximate result, the patient's symptoms and diagnoses have resulted in physical limitations not present prior to using ZOSTAVAX. Upon internal review meningitis was considered medically significant. Additional information has been requested.
Itchiness; Redness of the whole injection arm; Soreness of the whole injection arm; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchiness), INJECTION SITE ERYTHEMA (Redness of the whole injection arm) and INJECTION SITE PAIN (Soreness of the whole injection arm) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRURITUS (Itchiness), INJECTION SITE ERYTHEMA (Redness of the whole injection arm) and INJECTION SITE PAIN (Soreness of the whole injection arm). At the time of the report, PRURITUS (Itchiness), INJECTION SITE ERYTHEMA (Redness of the whole injection arm) and INJECTION SITE PAIN (Soreness of the whole injection arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.        No relevant concomitant medications were reported  Treatment details included Benadryl   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 18-Feb-2021: No specific follow-up information recorded.
Moderately painful (6/10) intermittent headache from 05:30 am to 3:00 pm. Pain was across the back of my head starting at the back of each ear, and across the back. Back of the head and ears were tender to palpation. Headache felt like an electrical shock across the back of my head, happening about 5-10 times per hour.  Only treatment I tried was Excedrin, without benefit. Pain succeeded on its own approx. 3 hours after Excedrin was taken by mouth.  I rarely have headaches <6 times per year.
5/31/21 10:50a vaccine administered. Pt anxious and feel like vomiting. Pt vomited. Pt didn't eat breakfast. Pt reported felt clamish. Pt then felt like she will move her bowel. Pt escorted to washroom and had diarrhea. 11:07a pt had a bowel movement. Pt was monitored and after drinking orange juice felt better. 11:19a Pt felt better and left with Mom and Grandmother.
On day 8 after vaccine the injection site started being itchy. It swelled, became red, and was noticeably warm to the touch. Over about 5 hours the redness and swelling had reduced (though not completely). Waking up on day 9 it is still itchy, warm to the touch, and slightly swollen. I have not taken any over the counter medications to counteract the symptoms.
Patient was receiving a flu shot and after the shot was administered and removed started bleeding substantially. After bandage administration, bleeding stopped fairly quickly. Upon going to replace the bandage there was bruising/swelling at the injection site, likely a hematoma
Rash on upper right chest, rear right neck, rear left neck; This is a spontaneous report from a contactable consumer, the patient. A 54-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 14Apr2021 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. Medical history included unspecified allergies. 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. Concomitant medication included over the counter (OTC) levocetirizine dihydrochloride (XYZAL) from an unknown date and unknown if ongoing for an unknown indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via an unspecified route of administration in the left arm on 24Mar2021 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. On an unknown date in May2021, the patient experienced rash on upper right chest, rear right neck, rear left neck. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event rash on upper right chest, rear right neck, rear left neck was not resolved at the time of this report.
Menveo lyophilized component with a non-GSK diluent and inadvertently administered the dose; Menveo lyophilized component with a non-GSK diluent and inadvertently administered the dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 17-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMV926A, expiry date 30-MAY-2024) for prophylaxis.   On 14-AUG-2023, the patient received Menveo (left deltoid). On 14-AUG-2023, an unknown time after receiving Menveo, the patient experienced wrong solution used in drug reconstitution (Verbatim: Menveo lyophilized component with a non-GSK diluent and inadvertently administered the dose) and inappropriate dose of vaccine administered (Verbatim: Menveo lyophilized component with a non-GSK diluent and inadvertently administered the dose).  The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 7-Sept-2023 Licensed practical nurse called to inquired that the patient would need to be revaccinated and how to proceed. Did not consent to follow-up. The nurse reconstituted the Menveo lyophilized component with a non-GSK diluent and inadvertently administered the dose to a patient, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.
Information has been received from a physician concerning a two 6 week old patients were vaccinated with a dose of Rotateq (human-bovine). Suspect vaccination administered that day included Pediarix and diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid. Subsequently, one day after vaccination, the patients developed a fever of 101F. The temps came down and were back to normal within 24 hours. Unspecified medical attention was sought. Subsequently, the patient recovered. Attempt are being made to obtain additional identifying information to distinguish the patients mentioned in this report. Additional information will be provided if available.
VACCINE WAS ADMINISTERED AFTER THE 30 DAY PERIOD THAT THE VACCINE IS ALLOWED TO BE STORED IN THE REFRIGERATOR.  PATIENT DID NOT REPORT ANY ADVERSE EFFECT TO THE VACCINATION SHE RECEIVED.
Pt came in after few months states when she got shot her arm swelled and was painful. Also, she now is experiencing pain from the arm to neck. At time (and few weeks after could not lift weeks).