chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in an adult 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.    Concurrent medical conditions included Rheumatoid arthritis.   In October 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. On an unknown date, the patient experienced COVID-19 (COVID-19) (seriousness criterion hospitalization). The patient was treated with REMDESIVIR for COVID-19, at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID-19) was resolving.            It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Concomitant medication was not provided.  The patient was in hospital with Covid 19 and had been in there for a few days.  CC: This spontaneous case concerns a 61 year old female patient, with concomitant use of adalimumab for rheumatoid arthritis, who experienced the unexpected, serious (hospitalization) Adverse Event of Special Interest of COVID-19, which occurred unknown days after the third dose of mRNA-1273 vaccine administration. The patient was hospitalized with Covid 19 and had been in there for a few days and was treated with REMDESIVIR. The ongoing COVID-19 pandemic and concomitant use of adalimumab (immunosuppressant) for rheumatoid arthritis could be confounders for the event COVID-19. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 61 year old female patient, with concomitant use of adalimumab for rheumatoid arthritis, who experienced the unexpected, serious (hospitalization) Adverse Event of Special Interest of COVID-19, which occurred unknown days after the third dose of mRNA-1273 vaccine administration. The patient was hospitalized with Covid 19 and had been in there for a few days and was treated with REMDESIVIR. The ongoing COVID-19 pandemic and concomitant use of adalimumab (immunosuppressant) for rheumatoid arthritis could be confounders for the event COVID-19. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Patient was given Anthrax vaccine for deployment. Responsible physician name is unknown. Next day (5 October 2007) patient had rash to cheeks and forehead. Pruritus noted and also pruritus to throat.
I experienced numbness and tingling down my left arm and it went all the way down to my leg and high blood pressure.
Arm pit pain; sweats for days; Serve swollen lymph nodes.; Chills; This is a spontaneous report from a contactable consumer, the patient. A 21-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EP6955) via an unspecified route of administration in the arm left on 12Apr2021 at 09:00 (at the age of 21-year-old) as a single dose for COVID-19 immunisation. Medical history included allergy to nickel. The patient did not receive any medication within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EL3247) via an unspecified route of administration in the left arm on 22Mar2021 at 09:00 (at the age of 21-year-old) as a single dose COVID-19 immunisation. 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. On 12Apr2021 at 22:00, the patient experienced serve swollen lymph nodes, arm pit pain, chills and sweats for days. The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events swollen lymph nodes, arm pit pain, chills and sweating was recovering at the time of this report.    No follow-up attempts are needed. No further information is expected.
Fever max 102, began 12 hours after vaccine. Resolved w/in 24 hours. Myalgias, abdominal pain, bad headache, nausea. Taking Ibuprofen & TYLENOL. Illness improved gradually, At this time headache only.
Had flu shot-FLUZONE HD PF 2017-18 INJ SAN woke up at 3:30 am with fever of 100.6 itchy eyes and face swollen, took TYLENOL. Body aches all over. Restless sleep until noon next day. Fever did not break until then but was back that night but low99.7. 10/07/2017 still slight swelling in face and eyes but no fever. Have had regular flu shot every yr prior with no reaction.
With second dose of vaccine series: swelling in the arm pit area of vaccinated arm. Occured 48hrs after vaccination. Resolving within 72hrs of vaccination
Developed generalized pink maculo-papular rash on 3/8/09 about 24 hrs prior to being seen. No fever. No other symptons - completed Augmentin for otitis about 24 hours prior to apperance of rash.
Eight days after vaccination my left arm felt numb and the left half of my face felt strange. I could still use the left size of my face did not seem to work correctly. The area around my Deltoid muscle was swollen to the size of a softball and it was very painful. I called my doctor and they thought it was a side effect of the vaccine. It took five days before I started to have full feeling in my face and for the swelling to go down in my arm. My arm was little tender for a couple of weeks but the swelling had gone down. but my face felt better. I got the second dose in the other arm. I had similar swelling but not as severe. I did have dizziness for three days. I still have a little tingling in my left arm since the first dose.
CONFIRMED COVID-19 INFECTION; BEDRIDDEN FOR DAYS; This spontaneous report received from a patient concerned a 30 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient was pretty healthy before vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1855191, expiry: UNKNOWN) dose was not reported, administered on 20-DEC-2021 for prophylactic vaccination. Age at time of vaccination 30 years old. No concomitant medications were reported. On 01-JAN-2022, the patient experienced confirmed covid-19 infection, and bedridden for days. Laboratory data included: COVID-19 virus test Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from confirmed covid-19 infection, and bedridden for days on 05-JAN-2022. This report was non-serious.
The patient was given the fluarix vaccine in the left arm and was completely fine. The patient was then administered the Gardasil-9 in the right arm before the patient said "that didn't feel too good," before he passed out/possible seizure for 10 seconds and 911 was called immediately. The patient regained consciousness after about 15 seconds from the time he had lost consciousness  was coherent, alert, and oriented.
headache; left arm hurt; tired/wiped out for a week; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), VACCINATION SITE PAIN (left arm hurt) and FATIGUE (tired/wiped out for a week) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 20-Feb-2021, the patient experienced HEADACHE (headache), VACCINATION SITE PAIN (left arm hurt) and FATIGUE (tired/wiped out for a week). At the time of the report, HEADACHE (headache), VACCINATION SITE PAIN (left arm hurt) and FATIGUE (tired/wiped out for a week) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications were reported.   The patient reported of being tired, wiped out for a week.  No treatment details were reported.   This case was linked to MOD-2022-526422, MOD-2022-526424, MOD-2022-526426 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Mar-2022: Follow-up information contain non significant information-reporter's details updated.
Fever, up to 102.8 F. Irritability. Inability to sleep.
Patient reports four days following her second dose of Shingrix given on 10/17/2019, she developed dime size welts on her trunk and thighs which would last a few hours and then move to another area.  This prompted her to seek medical treatment on 10/21/2019.  Her provider advised her that she was experiencing a possible allergic reaction to the Shringrix vaccine and was prescribed a Medrol dose pack and advised to take an over-the-counter antihistamine until her symptoms resolve.  During this time she states she also experienced a 3-inch welt at the injection site, itching on her scalp, stomach and eye irritation, physical weakness, and lightheadedness.  Today (10/29/2019), She reports that she is still taking an antihistamine but plans to stop this medication in the next few days.  She reports she is still experiencing some physical weakness and lightheadedness.
Rash on skin/butt/thighs/hands/back; A spontaneous report was received from a nurse concerning a 76-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced skin rash, rash on butt, rash on thighs, rash on hands, rash on back.   The patient's medical history, as provided by the reporter was unknown. concomitant medications provided by reporter was unknown.  On 27-Jan-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 032L20A) intramuscularly for prophylaxis of COVID-19 infection.   On 27-Jan-2021, the patient experienced skin rash, rash on butt, rash on thighs, rash on hands, rash on back.   Treatment for the events included topical steroid cream, oral steroid.  Action taken with mRNA-1273 in response to the events was not reported.   The events, skin  rash, rash on butt, rash on thighs, rash on hands, rash on back were unknown.  Based on MSA comment, Rash (change listedness to listed and unlisted for Canadian monograph and factsheet)
pt recv vax 13MAR98 & 15MAR98 pt awoke w/rt arm swollen from top of shoulders to elbow-arm was red w/white splotches, hot to touch;pt was taken to urgent care-recommended DPH, APAP & hot compresses;
About 15-16 minutes after the shot I got elevetad heart rate, tingling and numbness in tongue and mouth palate.  I had left the facility so decided to walk outside. Hart pulse got better in about 30 minutes, but the tongue tingling stayed. About 1 hour after the shot, the tingling  got more intense and spread on my face around my mouth and chicks. I felt intense burning above my lips, looked in the Mirror and saw that my upper lip was swallen and red. Went back to the vaccination site, and talked to a paramedic. She said to take Benadryl. It is now 1 week after the shot. Tingling and numbness are getting worse in my mouth and tongue. A doctor prescribed me coticosteroids. He said I should take then to prevent anafilactic shock from the vaccine.  I still have the tingling. When tingling and numbness in tongue and throat starts increasing, I have a feeling that my throat is closing and it is difficult I breathe.
Bad headache, chills, fever, nausea, redness at injection site, stomach ache, weakness.  The injection was on Friday and Saturday we woke up with the side effects.  Sunday we were much better and Monday  better.
Vaccine given at 07:50 (AM), with no immediate concerns. Within 4-6 hours, soreness at injection site was noted (soreness took 12-18 hours to start after first dose) By 8 hours after vaccination, had generalized "tingling" like a flu prodrome. By 12 hours after vaccination, experienced generalized aches, chills, mild headache and ipsilateral axillary lymphadenitis All symptoms persisted for 48 hours before resolution, except for axillary lymph node pain. Axillary lymphadenitis persisting , but resolving, by 72 hours after vaccination.
then tested Ag positive 21Apr2022; sick for 2 weeks URI sx (symptoms) but tested neg covid , then 18Apr partner with cold symptoms, then 4/20 he had more cough then fever through the night and then tested Ag positive 4/21/22; sick for 2 weeks URI sx (symptoms); fever; more cough; This is a spontaneous report received from a non-contactable reporter (Nurse).  A male patient received BNT162b2 (BNT162B2), as dose 1, single (Lot number: EL3247), as dose 2, single (Lot number: EL3247) and on 23Nov2021 as dose 3 (booster), single (Lot number: FF2589) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported:COUGH (non-serious) with onset 20Apr2021, outcome "unknown", described as "more cough"; PYREXIA (non-serious) with onset 20Apr2022, outcome "unknown", described as "fever"; RESPIRATORY SYMPTOM (non-serious) with onset 20Apr2022, outcome "unknown", described as "sick for 2 weeks URI sx (symptoms)"; COVID-19 (medically significant) with onset 20Apr2022, outcome "unknown", described as "sick for 2 weeks URI sx (symptoms) but tested neg covid , then 18Apr partner with cold symptoms, then 4/20 he had more cough then fever through the night and then tested Ag positive 4/21/22"; DRUG INEFFECTIVE (medically significant) with onset 20Apr2022, outcome "unknown", described as "then tested Ag positive 21Apr2022". The patient underwent the following laboratory tests and procedures: URI: (Apr2022) Negative, notes: sick for 2 weeks URI sx (symptoms) but tested neg; SARS-CoV-2 test: (21Apr2022) Positive, notes: Home Ag. It was unknown if therapeutic measures were taken as a result of drug ineffective, covid-19, respiratory symptom, cough, pyrexia.  Additional information: It was reported that the patient was sick for 2 weeks with URI symptoms but tested negative for COVID. On 18Apr2022, patient's partner had cold symptoms. On 20Apr2022, the patient had more cough then fever through the night and then tested Ag positive on 21Apr2022. Facility type vaccine: Workplace clinic.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events Drug ineffective, COVID-19  and the use of suspect product BNT162B2 cannot be fully excluded.,Linked Report(s) : US-PFIZER INC-202200610046 Same patient and drug, different event separated in time
pt received per chart hx vaccine on 03/25/2021.  dx with covid on 02/28/2022.
Initial report was received 31 August 2011 from a consumer who was a co-worker of the patient. A female patient (age and date of birth not reported), who was fit and worked out, had received an injection of swine INFLUENZA VACCINE during the 1970s and right before Christmas, she became ill. The patient died two years later. According to the reporter, at first they thought it was GBS (Guillain-Barre Syndrome), but it was found to be "something else" (unknown by the reporter). Per the reporter, she had no additional information to provide regarding this event. The reporter further stated that the business where they worked had been bought and sold several times and had since gone out of business; therefore, there is no one to contact for follow-up. The reporter for this case is the same as for case numbers 2011-08149 and 2011-08150.
Vaccine was given approximately at 1130. Patient was sitting in the waiting are for the 15 minute waiting period. At 1145 he stated he was getting up to leave and was putting on his jacket and "tripped" over it. He fell to his knees. Writer did not witness fall but he states that he did not hit his head and bystanders confirmed this. He was able to get up with assistance. He reported dizziness that started a few minutes after the vaccine. His heart rate was 97. Blood pressure was 152/88 at 11:50 AM and 148/80 at 12 PM.  He states he had not yet eaten that day.  At 12 PM he states he was feeling better. Denied dizziness, pain, nausea, palpitations, weakness. Hand strength equal. No facial drooping, clear speech. He was able to stand with no dizziness. He was able to put his coat on without assistance.  I monitored him walking the length of the facility and out to his vehicle where he was able to get in with no assistance.  He was advised to follow up with his doctor regarding elevated blood pressure and fall.
This spontaneous report was received from a nurse regarding unspecified patients of unknown age and gender. Information regarding the patients' pertinent medical history, drug reactions/allergies and concomitant medication were not provided. On unspecified dates, the patients were vaccinated with unspecified doses of improperly stored RECOMBIVAX HB (lot/batch# 1039660 with an expiry date 04-FEB-2018 and dosing details not known). No adverse reactions reported. There was no product quality complaint (PQC) involved. Lot number 1039660 is an invalid lot number for hepatitis B vaccine (recombinant). This is one of the four reports received from the same reporter. Additional information has been requested.
Complaints of itching and rash to neck area which eased up. Later noticed itching and rash to arms.
Pt received DT and experienced local reaction consisting of 8X6CM erythema, induration & edema w/pain after injection.
Vaccine was given to the child's mother in the first trimester of her pregnancy. The child seen in consultation by the doctor 12/28/00 and diagnosis is pervasive developmental disorder, nos. The follow up received on 8/15/01 states please note that this case has a duplicate VAERS number (second VAERS number assigned to this case is VAERS reference 166116). The pt in this case was a 19 year old female who received the Anthrax vaccine during her pregnancy. Her daughter was diagnosed with PDD. Follow-up info received from the child's pediatrician noted that the child had improved, but a full recovery is not expected.
Bexsero vaccine was given on Monday 9/23/19. About 30-60 minutes following injection she started having nausea, swelling at injection site, discomfort at injection site and muscle VERY sore. This continued for the next two days, by Thursday 9/26/19 she wasn't nauseated any more, but injection site was very swollen, "about the size of a baseball". Swelling went down and patient left for a volleyball tournament over the weekend. Coach called on Saturday 9/28 because the shoulder/upper arm had hard red blotchy patches that were warm to the touch. Mom had coach bring her to UC, where the NP thought it was local reaction, gave steroid cream, which has helped some, red patches still there, but softening up, still itchy. I spoke w/ mom today, 10/8/19, Patient has recovered from response, no longer swollen, itchy or red. She did use steroid cream for several days and took about 2-3 days' worth of Zyrtec as well.
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 77-year-old patient received BNT162b2 (BNT162B2), on 07Apr2022 as dose 4 (booster), single (Lot number: FM0698) at the age of 77 years, in left arm for COVID-19 immunization; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 30Jan2021 as dose 1, single (Lot number: 042L20A), in left arm, on 27Feb2021 as dose 2, single (Lot number: 023M20A), in left arm and on 16Sep2021 as dose 3 (booster), single (Lot number: 026C21A), in left arm for COVID-19 immunization. The patient's relevant medical history included: "Gout" (unspecified if ongoing); "Interchange of Vaccine Products" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Clindamycin, reaction(s): "known allergies: clindamycin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medi-cally significant) all with onset Jun2022, outcome "unknown" and all described as "COVID 19 Treat-ment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jun2022) Negative; (Jun2022) Positive; (Jun2022) Positive. Therapeutic measures were taken as a re-sult of drug ineffective, covid-19. Patient had received anti-viral medication (Paxlovid) for COVID-19 Treatment which was started on14Jun2022 and stop date was 19Jun2022.
Late period. My periods are an average of 26-27 days. It has been 30 days now and no period. Not pregnant. The only difference in lifestyle this menstrual cycle was the vaccine.
Information has been received from a physician concerning a 12 year old female patient, who on approximately 16-AUG-2010, 4 months ago", was vaccinated with a first dose of GARDASIL (route and Lot # not reported). Approximately on 15-SEP-2010 the patient received the second dose of GARDASIL (route and Lot # not reported). The physician reported that on approximately 15-OCT-2010, "two months ago", the patient was diagnosed with "molluscum contagiosum", "one month after" receiving her second dose of GARDASIL which occurred on the face and neck area. The patient was currently being treated by a dermatologist. At the time of the report, the patient had not recovered. Additional information has been requested.
Shortness of breath, localized itching and skin discoloration beginning days after immunization.
"I have a high pitched ringing in my ears"; This is a spontaneous report from a contactable consumer, the patient. A 67-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in the left arm on 15Mar2021 (at the age of 67-years-old) as a single dose for COVID-19 immunisation. The patient had no past medical history and no known allergies to food, medications or other products. Concomitant medications included omega-3-acid ethyl ester (LOVAZA); for unspecified indication from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9266) via an unspecified route of administration in the left arm on 27Feb2021 (at the age of 67-years-old) as a single dose for COVID-19 immunisation. 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. On 17Mar2021 the patient experienced a high-pitched ringing in ears. It was diagnosed as tinnitus by ENT. Since the vaccination, the patient had not been tested for COVID-19. The event resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the event. The clinical outcome of the event "I have a high-pitched ringing in my ears" was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.