chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID-19 infection - positive test on 20Aug2021; COVID-19 infection - positive test on 20Aug2021; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 50-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. If other vaccine in four weeks was reported as unknown. The patient had been tested for COVID-19 since the vaccination. It was unknown if patient had covid prior vaccination. On 17Aug2021, after receiving the vaccine the patient experienced covid-19 infection - positive test on 20aug2021. The events were serious medically significant. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 20Aug2021. Treatment received for the events was reported was unknown. The outcome of the events was not recovered.  Information on the lot/batch number has been requested.
Patient woke up crying, he was running a fever, I gave him a bath, while I was toweling him dry, he started having a seizure, his eyes rolled back, his jaw started jerking, as well as arms and legs, he started turning blue around his mouth and eyes. Since then, he's had five more convulsions, the last around a month ago.
After injection pt suffered, chills, fever none. Pt. felt like, he had the flu. Also one episode of memory loss - for a few moments. This reported to the office on 11-17-11. Pt states started 11-15-11 evening.
Diffuse maculo-papular eruption in bilateral arms, chest, back, legs measuring from 3mm to 10mm in diameter starting 10 days after administration of smallpox vaccination.
woke up with a very red face that has been red for 5 hours or so; This is a spontaneous report from a contactable consumer (patient). A 22-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date: unknown), dose 1 via an unspecified route of administration on 31Mar2021 (at the age of 22 years) as dose 1, single for covid-19 immunisation. The medical history and concomitant medications were not reported. The patient woke up with a very red face that has been red for 5 hours or so on 01Apr2021 and it had not gone down. Her face never got red at all ever. She wanted to know if that was normal or should she be concerned. The outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.
pt recvd vax; pt devel swollen joints & hives; pt taken to allergist;
Pt. received PNEUMOVAX vaccine 8/87/12. Pt. called 8/31/12 stating arm was swollen & red. Condition continued to worsen to severe swelling, redness, pain, tenderness and joint pain. PCP told pt. cold compresses & ibu for treatment.
I had a head cold, lots of mucus, chest infection, chest congestion, coughing, muscle weakness, extreme fatigue, headache, low grade fever, loss of appetite, and loss taste and smell for a couple of months. I work for a medical center, and they tested me there. I was positive for COVID-19. I talked to my doctor and told him I had COVID-19. He did not prescribe me anything, I just took over the counter medications.
This spontaneous report as received from a pharmacist refers to a 1 year old male patient. The patient's medical history included ear infections. The patient had no drug reactions/allergies. On 10-SEP-2013 the patient was vaccinated with MMR II HAS (lot # 0425AE, expiration date 27-FEB-2014) 0.5 ml once for routine vaccination (route was not reported). Concomitant medications were not reported. In September 2013, 10 hrs. after received MMR II the patient experienced 102F fever. The patient's mother, an unspecified nurse practitioner, had been alternating Tylenol and ibuprofen (unspecified) every 4 hours to treat the patient's fever. The outcome of fever was reported as not recovered/not resolved. No lab diagnostic were performed. The relationship between the MMR II and the fever was not reported. Additional information has been requested.
slight dry cough; tested positive for COVID-19; loss of some taste and smell; loss of smell; arm was a little bit sore; chills; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (loss of some taste and smell), ANOSMIA (loss of smell), COUGH (slight dry cough), COVID-19 (tested positive for COVID-19) and PAIN IN EXTREMITY (arm was a little bit sore) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A and 047A21A) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included ROSUVASTATIN, HYDROCHLOROTHIAZIDE and METOPROLOL for an unknown indication.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Feb-2021, the patient experienced PAIN IN EXTREMITY (arm was a little bit sore) and CHILLS (chills). On 18-Feb-2021, the patient experienced AGEUSIA (loss of some taste and smell) and ANOSMIA (loss of smell). On 19-Feb-2021, the patient experienced COUGH (slight dry cough) and COVID-19 (tested positive for COVID-19). The patient was treated with PARACETAMOL (TYLENOL) for Prevention, at an unspecified dose and frequency. On 27-Apr-2021, AGEUSIA (loss of some taste and smell), ANOSMIA (loss of smell) and COUGH (slight dry cough) had resolved. At the time of the report, COVID-19 (tested positive for COVID-19) had resolved and PAIN IN EXTREMITY (arm was a little bit sore) and CHILLS (chills) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Feb-2021, SARS-CoV-2 test: positive (Positive) Tested positive for Covid-19.         The patient stated that she quarantined from 19Feb2021 to 06Mar2021 which was 15 days. Reportedly, the patient was asymptomatic after her second dose.   Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: Initial additional included- route of administration of vaccine, 2nd dose details, concomitant medications, new event and updated stop date of event .
Student reported to nurses @ 2:40 PM that she vomited 3 times starting @ 11:45 AM. V.S.: 98.6 Pulsre 88 BP 118/80. Skin color normal. Skin warm & dry. Injection site RD painful but no redness noted.
2-3 month history of gradual hair loss. Currently being evaluated by Dermatology.
Pt has a history of diabetes, CKD, obstructive sleep apnea, and uses cocaine.  For the past 4 days before admission he had fever, generalized body aches, decreased appetite, cough, and shortness of breath.  Pt was found to be hypoxic on room air.
12 hours post vaccine: Developed fatigue, nausea, chills, body aches.  No fever recorded.  Injection site felt hot and swollen but did not appear swollen. 18 hours post vaccine: Took 1000 mg tylenol and went back to sleep 20 hours post vaccine: Woke up feeling better, went to work 24 hours post vaccine: Developed bad headache, fatigue and nausea again 30 hours post vaccine: Took 1000 mg tylenol and 500 mg ibuprofen 32 hours post vaccine: Almost all symptoms gone, only mild residual injection site soreness still present
Developed a cough; Developed body aches; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Developed a cough) and PAIN (Developed body aches) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COUGH (Developed a cough) and PAIN (Developed body aches). At the time of the report, COUGH (Developed a cough) and PAIN (Developed body aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Triggered rapid heart beat  that started morning after the dosealong with other more expected sx, lasted 16 hours at rate of 100-130 and was still occurring when I went to bed.  Had stopped by morning when I awoke. Extra flecainide didn?t interrupt it at all.  A 20 mg dose of propranolol brought rate down to 99 just before bedtime.
large quarter sized hives all over; This is a spontaneous report from a contactable nurse (patient). A 35-year-old female patient (pregnant: No) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), via unspecified route of administration on left arm on 05Feb2021 at 08:30 AM at single dose for COVID-19 immunization. The relevant medical history included known allergies: lyrica, possibly cilantro, pollens; insulin resistance; vitamin D def (Vitamin D deficiency); GERD (Gastrooesophageal reflux disease). Concomitant medications included metformin, famotidine (PEPCID), clarithromycin (CLARTIN), topirmate, diphenhydramine hydrochloride (BENEDRYL). The patient previously received first dose of BNT162B2 (lot number: EH9899) at the age of 35 years old, via unspecified route of administration on left arm on 11Jan2021 at 03:30 PM for COVID-19 immunization (first vaccine administered and was fine then had hives and swollen eye on the day the second was to be administered. Delayed shot- received solumedrol shot and prednisone oral with benedryl/pepcid/atarax). The patient took second shot 1 week later on Friday with prednisone on board - woke up on Sunday AM with large quarter sized hives all over. The event resulted in emergency room/department or urgent care. The event was reported serious due to hospitalization. Treatment received included urgent care- Solumedrol shot- RXs. No other vaccine in four weeks. The outcome of the event was recovering.; Sender's Comments: Based on available information and plausible temporal association,  a possible contributory role of the subject drug BNT162B2 cannot be excluded for the reported event large quarter sized hives all over. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sore, redened at injection site; progressed to muscle cramping through arm above injection site and to rear of back. Continues to the present time ( 30 days).  Treatment- occasional Tylenol & hot compress
VAERS completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose04/15/21 2nd dose05/06/21 Diagnosed covid positive:08/16/21 Symptom onset:08/18/21 Exposure: Symptoms:Cough, fatigue,runny nose,HA, sore throat.
Patient began to bleed from site of injection immediately following vaccination. She said it took 2 hours to stop the bleeding, but there was no pain. She had a large bruise at site of injection that is now fading away (as of 10/11/18).
Sinus Infection; This spontaneous case was reported by a consumer and describes the occurrence of SINUSITIS (Sinus Infection) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included DOXYCYCLINE for an unknown indication.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 1. On an unknown date, the patient experienced SINUSITIS (Sinus Infection). At the time of the report, SINUSITIS (Sinus Infection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
Shoulder pain - shortly following  Fatigue, nausea and slight fever the next morning  Lasted until sleep, woke next morning better with residual arm pain,
Feel fatigued; Bit hot; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN0161) via an unspecified route of administration in the left arm on 13May2021 at 08:30 (at the age of 31-year-old) as a single dose for COVID-19 immunisation. It was reported that patient did not know if he had any medical history or known allergies. Prior to the vaccination, the patient was diagnosed with COVID-19 (reported as no). On 03Dec2020, the patient underwent test COVID-19 test and the result was negative. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN0153) via an unspecified route of administration in the left arm on 22Apr2021 at 08:30 (at the age of 31-year-old) as a single dose for COVID-19 immunisation. On 13May2021 at 22:00, (reported as 15 hours) after the second dose of vaccine the patient felt fatigued and a bit hot. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19 (reported as yes). Therapeutic measures were not taken as a result of the events. The clinical outcome of the event felt fatigued and a bit hot was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Dose 1 given 1/14/2021 (batch/lot # 037K20A). Patient hospitalized with COVID-19.
Symptoms started with joint pain, headache, and redness with swelling at immunization site. Progressed with addition of fever in evening. Patient took ibuprofen. Fever, aches and joint pain gone by 12/1/11 but redness and swelling of site is spreading. Patient went to urgent care afternoon of 12/1/11 and received rx for prednisone and OTC diphenhydramine.
Swelling, itching, and redness around area where shot was given. I have redness and feel hot around the area where shot was given. Also, feels itchy and feels like area is swollen.
Full body hives (except face, but ears were red and completely swollen) for two full days, beginning 5 days after injection. Treated with one Zyrtec each morning and hydrocortisone cream on hives. Second day I added 50mg of Benadryl along with the morning Zyrtec, another 50 mg of Benadryl 6.5 hours later and then 25mg of Benadryl 6 hours later. First day was spotty hives all over body, and second day was worse with both arms covered, lower back/upper butt covered, and full thighs covered and left knee and about 1in below covered. Also had hives on top of right foot and inner ankle for both feet, and on the back of and palm of my left hand. I?ve never had hives before, ever.
EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a health care professional concerned a 25 year old male. 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: 043A21A, expiry: 19-SEP-2021) dose was not reported, administered on SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On SEP-2021, the patient experienced expired vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine administered was not reported. This report was non-serious. This case, from the same reporter is linked to 20210949302, 20210949996, 20210949974 and 20210950004.
Skin Reaction and Chest Pain. Large wheals on arms, face, head, buttock, legs.  Virtual appointment on  3/25/21 resulted in Prednisone being subscribed. When the prednisone gone, the wheals and worsened chest pain came back. Went to Emergency Room on 3/31/21  and diagnosed with Erythema Multiforme. Doctor could not confirm vaccination related, but ruled out all other possibilities and told my son NOT to take the 2nd dose of Moderna vaccine. He gave him stronger prednisone
Information has been received from a registered nurse concerning a 29 year old male with no known drug allergies and no past medical history who on 19Mar2003 was vaccinated SC with a first dose of varicella virus vaccine live. There was no illness at the time of vaccination. On 04Apr2003 the patient developed a rash on his face that spread to his chest, back and groin area on 05Apr2003. The reporter indicated that "there were about 15 lesions." It was also noted that the patient had a "negative titer". Unspecified medical attention was sought. Follow up information received from a registered nurse indicated that on 04Apr 2003, 16 days after vaccination, the patient developed a rash on his face, abdomen, and groin which was described as a "diffuse varicella-like rash". The patient was reported as recovered. No relevant diagnostic tests or laboratory data were reported. There were no adverse events following prior vaccinations of the patient or his siblings. No further information is expected.
I began spotting on Tuesday and my period began on Thursday.   This was more than a week early.  The period is distinguishable from my normal period.  I am not in menopause and I am on the birth control pill so my period comes like clock work.  After the first dose of the vaccine I did have a little spotting for a day or two.  I know one other person that is experiencing the same thing.  She is also same age as me .  Something is not right.
Redness and swelling of right and left deltoids.  Patient also had a rash.  She had received the varicella vaccine and an investigational DTaP/polio combination.  The diagnosis was acute cellulitis, allergic reaction/dermatitis.  Treatment consisted on ice and Benadryl, which improved the redness and swelling.
Only diluent administered.; Only diluent administered.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 18-year-old male patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On 20-JUN-2023, the patient received Menveo. On 20-JUN-2023, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: Only diluent administered.) and inappropriate dose of vaccine administered (Verbatim: Only diluent administered.). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 26-JUN-2023 The reporter consented to follow up. A patient was inadvertently administered only the liquid component of Menveo, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Expired covid vaccine administered. Covid vaccine lot number FM7553 expired 6/30/2022 and administered 7/6/2022.  Patient doing well, does not report any adverse reaction.
Patient received 1st dose of Pfizer vaccine. Patient likely vasovagal, blood pressure 56/33 initially. Patient stated that she almost completely lost her vision. Patient extremely pale and cold and clammy. Patient stated she did eat breakfast this morning and had not had a reaction like this in the past. Patient provided with a sugar source and was placed supine. Blood pressure 105/63. Patient monitored for 30 minutes and sent home.
shot given on the 4th Went in on Friday the 15th  and had prolia injection.  was given in the right arm as a sub Q the injection sites were a good 8 inches apart. after the injection i didn't have any redness. on Monday i started having right ear pain, runny nose more then usual. stayed the same up unit last nigh the 20th. about 7:30 pm right collar bone and muscles and my right ear was more painful and going down the right side going to the back and rib area. took aspirin, about an hr later went to bed and applied heat pad to the area with no relief. Got up about 11:00 pm pain was getting worse i and now in my ribs swelling around the collar bone and sternum . Have never had reaction from the prolia shot before. Went to the hospital last night
Rheumatoid arthritis worsen; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid arthritis worsen) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    No Medical History information was reported.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthritis worsen) (seriousness criterion medically significant). The patient was treated with NIRMATRELVIR in 2021 for Arthritis rheumatoid aggravated, at an unspecified dose and frequency and RITONAVIR in 2021 for Arthritis rheumatoid aggravated, at an unspecified dose and frequency. At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid arthritis worsen) was resolving.            No concomitant product was provided. The patient was treated with Nirmatrelvir and Ritonavir. The reporter's causality for the event rheumatoid arthritis worsen with co-suspect Humira was not provided. It was unknown if patient was enrolled in a COVID-19 vaccine trial.  Company Comment:  This is a spontaneous case concerning  a  62-year-old, female patient with no reported medical history, who experienced the unexpected serious (medically significant) AESI  event of Rheumatoid arthritis. The event occurred in 2021 of unknown month and date. On an unknown date patient started on Adalimumab at unknown dose. It is reported that patient received first dose of mRNA-1273 COVID 19 Vaccine administered on January 28, 2021 and second dose of mRNA-1273 COVID 19 Vaccine was administered on February 25, 2021. Patient was treated with nirmatrelvir and ritonavir of unknown dosage and frequency. The event was reported as resolving. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.; Sender's Comments: Company Comment:  This is a spontaneous case concerning  a  62-year-old, female patient with no reported medical history, who experienced the unexpected serious (medically significant) AESI  event of Rheumatoid arthritis. The event occurred in 2021 of unknown month and date. On an unknown date patient started on Adalimumab at unknown dose. It is reported that patient received first dose of mRNA-1273 COVID 19 Vaccine administered on January 28, 2021 and second dose of mRNA-1273 COVID 19 Vaccine was administered on February 25, 2021. Patient was treated with nirmatrelvir and ritonavir of unknown dosage and frequency. The event was reported as resolving. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.