chrisvoncsefalvay/vaers-outcomes huggingface dataset:
PANUVEITIS FLARE UP; MORE INFLAMMATION AFTER RECEIVING MODERNA COVID; HAD A HEADACHE AFTER RECEIVING MODERNA COVID VACCINE with HUMIRA; This spontaneous case was reported by a consumer and describes the occurrence of UVEITIS (PANUVEITIS FLARE UP) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Panuveitis.    Concurrent medical conditions included Panuveitis.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) UNK, Citrate free. On an unknown date, the patient experienced UVEITIS (PANUVEITIS FLARE UP) (seriousness criterion medically significant), INFLAMMATION (MORE INFLAMMATION AFTER RECEIVING MODERNA COVID) and HEADACHE (HAD A HEADACHE AFTER RECEIVING MODERNA COVID VACCINE with HUMIRA). At the time of the report, UVEITIS (PANUVEITIS FLARE UP) had not resolved and INFLAMMATION (MORE INFLAMMATION AFTER RECEIVING MODERNA COVID) and HEADACHE (HAD A HEADACHE AFTER RECEIVING MODERNA COVID VACCINE with HUMIRA) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. It was reported that on unknown dates, the patient experienced panuveitis flare up, more inflammation after receiving moderna covid vaccine and had a headache after receiving moderna covid vaccine. It was unknown if patient was enrolled in a covid-19 vaccine trial. patient received moderna covid-19 vaccine. No treatment medications were reported. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company comment: This spontaneous case concerns a 60-year-old male patient with medical history of uveitis, who experienced the unexpected, serious (medically significant) event of uveitis an unknown time after a dose of mRNA-1273. The event was described as a flare up. Uveitis can present relapses as part of the natural history of disease, so that could be a contributory factor for the event. Information regarding clinical evaluation, diagnostic tests and treatment provided has not been disclosed. Outcome was reported as not resolved. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 60-year-old male patient with medical history of uveitis, who experienced the unexpected, serious (medically significant) event of uveitis an unknown time after a dose of mRNA-1273. The event was described as a flare up. Uveitis can present relapses as part of the natural history of disease, so that could be a contributory factor for the event. Information regarding clinical evaluation, diagnostic tests and treatment provided has not been disclosed. Outcome was reported as not resolved. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Received vaccine at 1130 AM, and at 0400 the following day, awoke from sleep feeling the worst dehydration she has ever had.  Got up and went to bathroom and then took water bottle to kitchen to fill.  Lost consciousness she believes for 20 minutes or longer .  Awakened on the floor with a cut to her right eyebrow and a bruise to her left shoulder.  She sustained a cut to her right eyebrow that required 7 sutures to close.  In ED a complete work up was done with negative Head CT, negative EKG, elevated D-dimer, but no evidence on Chest CT of pulmonary embolus.  ED diagnosis:  Dehydration due to side effects from receipt of Moderna, COVID-19 vaccine.
Patient rec'd pneumonia vaccine right deltoid on 11/13/08.  Patient reports that she began with chills and body aches that evening which then led to dry heaves.  By 11/15/08 patient presented to ER with CELLULITIS at injection site.  She was hospitalized overnight.  Pt developed chest pain also.  12/19/2008 MR received for DOS 11/16-17/2008 with DX: Right upper extremity cellulitis and chest pain. Pt presented with swelling and pain in Rarm. Pt also developed chest pressure and R arm discomfort. PE (+) for RUE erythema, warmth and tenderness and shingles rash present prior to vax. Tx with abx and Valtrex for shingles.
Sore arm (Nothing surprising, but reporting it anyway); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Sep2023 at 12:30 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 49 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (DOSE 3 (BOOSTER), Unknown Manufacturer), for COVID-19 immunization; Covid-19 vaccine (Primary Immunization Series Completed, Unknown Manufacturer), for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 20Sep2023 at 16:00, outcome "not recovered", described as "Sore arm (Nothing surprising, but reporting it anyway)". Therapeutic measures were not taken as a result of pain in extremity.  Additional information: No covid prior vaccination. No covid tested post vaccination. No known allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101291962 Same patient/vaccine, different vaccine dose/event;US-PFIZER INC-2021238603 Same patient/vaccine, different vaccine dose/event;
This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. No concurrent conditions, medical history and concomitant medications were reported. On 16-MAR-2016, the patient was inadvertently vaccinated with expired dose of VARIVAX (Merck) (dosing details, route not reported) lot # J009729, expiry date: 07-AUG-2015. No adverse effect reported. There were no product quality complaints (PQC) involved. Additional information has been requested.
Directly after getting the shot 5/9/2021 4:05pm - current I've had a sore throat, started as tingling and then moved to pain after a few hours  Really bad Migraine from 5/10/2021 8:30am - 3:00pm  Bad diarrhea every time I eat 5/11/2021 5:30 am - current
Per pt her vision was blurry as she was receiving vaccine for a couple of seconds. Per pt she has this feeling  every time she gets struck by a needle. Per pt "it's not the vaccine" it's her fear of needles. Vital signs at 1:40pm  BP 148/96 HR 102. Vital signs taken at 1:55pm BP 132/82 HR 98. Last set of vitals signs taken at 2:12 BP 136/72 HR 88. Pt verbalized feeling fine at this . Pt left at 2:15 accompanied bt husband. no complaints voiced.
Glossitis - started 3-4 days after vaccine (interestingly her older brother also had a similar response after 2nd Moderna)
Pt recv vax on unknown dy; post vax (24-48 hr) pt exp fever (102F) w/ achey muscles
SIGNIFICANT SIDE EFFECTS FROM COVID VACCINE; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (SIGNIFICANT SIDE EFFECTS FROM COVID VACCINE) in a 45-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) for an unknown indication. There was no reported medical history. On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-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 IMMUNISATION REACTION (SIGNIFICANT SIDE EFFECTS FROM COVID VACCINE). At the time of the report, IMMUNISATION REACTION (SIGNIFICANT SIDE EFFECTS FROM COVID VACCINE) outcome was unknown.   Concomitant medications were not reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Treatment medications were not reported.
Tested positive for Covid after both Covid vaccines; Tested positive for Covid after both Covid vaccines; had a Covid exposure in another country; This is a spontaneous report received from a contactable physician. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, first dose on an unspecified date (Lot Number: Not Provided), second dose on an unspecified date (Lot Number: Not Provided), both at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Physician stated she had a question about whether Pfizer was interested in tracking people who tested positive for the Covid virus after having the Covid vaccine. Physician stated she was calling on behalf of her Nephew. Patient tested positive for Covid twice, after both Covid vaccines. Patient travelled and had a Covid exposure in another country. Patient had two positive Covid tests. Outcome of the events was unknown.   Information on the lot/batch number has been requested.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event Drug ineffective, COVID-19, exposure to SARS-CoV-2 and the suspect drug BNT162B2.
patient as administered 1 dose of improperly stored MMR II; no adverse effects reported; This spontaneous report as received from a physician refers to a patient of unknown age and gender. On 10-JUL-2019, the patient was vaccinated with the first dose of an improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (lot # R015165 exp date 29-MAY-2020) (route not reported) which was reconstituted with properly stored sterile diluent. A data logger issue was reported. The temperature of excursion was 50 °F for 4 hours. There was no previous temperature excursion. No adverse effects were reported.
This spontaneous report was received from a certified medical assistant referring to a patient of unknown age and gender. Patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with an expired dose of ZOSTAVAX, (lot # and expiry date not reported). Other co-suspect or concomitant medications were not reported. No adverse symptoms were reported. Additional information is not expected.
Information has been received from a physician concerning a 25 year old black female who on 10-JUL-2007 was vaccinated with her first dose of GARDASIL (lot # 0469U). On 12-SEP-2007 the patient was vaccinated with her second dose of GARDISIL (lot # 654539/0742U). Subsequently on 31-OCT-2007, "about six weeks after receiving GARDASIL the patient's eyes were swollen." The patient recovered from swollen eyes and was seen by an allergist. Additional information has been requested.
Bone, joint, and muscle pain starting 3 days after 2nd Phizer vaccine. Progressively worsening with headache.
Approx. 5 minutes, post vax, pt fainted in the lobby with her father at her side. After a few seconds, pt opened her eyes and said "I'm all right". Applied cool compress to forehead and back of neck. Per father, pt did not hit her head. Pt walked with assistance to exam room, with dad at her side. Pt stayed in room for the next 20 minutes, under observation. Per pt, "feel fine". She left clinic with her father. Follow-up call made to pt's home. Spoke to father who stated that pt is doing fine. Stated that she ate after leaving the clinic with no problems.
The patient has just been treated for pneumonia, it looks like this was diagnosed 10Oct; This is a spontaneous report received from contactable reporter(s) (Nurse).  An 8-year-old female patient received BNT162b2 (BNT162B2), on 17Dec2021 as dose 2, single (Lot number: FK5618, Expiration Date: 31Dec2021, NDC: 59267105504) at the age of 8 years for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: BNT162b2 (NDC: 59267105504, LOT: FK5127, EXP: 28Feb2022), administration date: 29Nov2021, when the patient was 7-year-old, for covid- 19 immunisation. The following information was reported: PNEUMONIA (hospitalization, medically significant) with onset 10Oct2022, outcome "unknown", described as "The patient has just been treated for pneumonia, it looks like this was diagnosed 10Oct". The patient was hospitalized for pneumonia (start date: 10Oct2022, discharge date: 16Oct2022, hospitalization duration: 6 day(s)). Therapeutic measures were taken as a result of pneumonia.  Additional information:The patient has just been treated for pneumonia, it looked like this was diagnosed 10Oct, and it looks like she was hospitalized on 10Oct thru 16Oct. There was no treatment mentioned for the hospitalization in the note.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported event: "Pneumonia" and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.   The impact of this report on the benefit/risk profile of the Pfizer drug 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.
Pt recv vax and one hour later exp fever, redness and swelling of her arm twice it's normal size.  Pt tx=prednisone for three days.
7 patients were administered doses from expired vial; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (7 patients were administered doses from expired vial) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038C21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (7 patients were administered doses from expired vial). At the time of the report, EXPIRED PRODUCT ADMINISTERED (7 patients were administered doses from expired vial) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
48 hours after injection child development stomach pain and diarrhea for the following 24 hours.
Patient fainted on first dose and was aware he may faint again. Patient ended up fainting shortly after second dose for less than 5 seconds. Paramedics came and explained he was experiencing vasovagal symptoms.  Patient was feeling well enough to walk within 5-10 minutes
Patient received a flu shot and PNEUMOVAX 23 in left deltoin, 1 inch apart on Thursday Oct. 5, 2017. That same evening her arm was sore so patient iced it and took ibuprofen for pain. Next day, upper right arm was more swollen. She continued with ice and ibuprofen. On Saturday Oct. 7, 2017 patient could not move her arm, whole circumference of upper right arm, below injection site was very red, and swollen and sore. Patient went to urgent care on 10/7/17 where she was advised to use topical hydrocortisone cream and allergy tablets. She was not given any antibiotics. On Wednesday Oct. 11, 2017 I saw the patient's arm. The swelling and soreness was gone. I followed up by phone conversation with the patient on 10/12/17 and the patient did not report swelling and felt better.
soreness during the first 3 days after injection; red area around injection site appeared 9 days after injection
Pt recvd Pneumovax 23 on 03OCT90; On 01DEC90 seen in MD's office stating arm still hurts from vax; Hurts to put arm into sleeve; PE revealed pain & tenderness over biceps tendinous groove; poss tendinitis;
I woke up and began to feel drainage and pressure in my sinuses.  There was a certain smell and taste modification as well.  I knew I was getting a sinus infection and went to the walk-in clinic.  I was prescribed Levofloxacin.  This medication did not help.  I have been using my Netty pot to help.  I have a CT scan for my nose scheduled next week to see if there are issues with my sinuses.  I suffer from sinus infections regularly.
I am having lot of Menstrual Bleeding; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 01Sep2021 (Lot number: FC3182) as dose 1, single and administered in arm left, administration date 27Sep2021 (Lot number: FF2588) as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: HEAVY MENSTRUAL BLEEDING (non-serious) with onset Sep2021, outcome "unknown", described as "I am having lot of Menstrual Bleeding". Therapeutic measures were not taken as a result of heavy menstrual bleeding.  Additional information: Patient age at the time of vaccination: Consumer stated, No. It was 47 at the time of vaccination because patient birth date, and patient got the first dose on 01Sep2021. Patient had the first dose on 01Sep2021 and then the second dose on 27Sep2021 and It started 2 weeks ago.  No follow-up attempts are possible. No further information is expected.
Patient reported nausea and diarrhea after 1st and 2nd dose, then severe nausea and vomiting after 3rd dose, Patient did not take 4th dose.
Patient called on 9/14/20 experiencing injection site reaction including redness and swelling at injection site.  On 9/16 she called and stated she was still feeling unwell--reported lethargy, a knot at the injection site and it felt a little itchy.  She stated she had "hives" for 2 hours around the injection site. On 9/18/20, she called back to let us know that she was still experiencing side effects including lethargy, knot at the injection site and general pain and "twinges".   Instructed patient to call doctor to be evaluated
Pt had fever x 2 day 101 after last Imm 9-7-10.
Low Grade Fever, Tiredness, Body /Muscle Aches, Joint Pain, Severe Headache, Nausea, Chills, Crying, Pain at the injection site
Tingling lips; tingling throat; pain in lips; pain in throat; bottom lip is swollen; looks like she got Botox in her lower lip; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA ORAL (Tingling lips), PHARYNGEAL PARAESTHESIA (tingling throat), LIP PAIN (pain in lips), OROPHARYNGEAL PAIN (pain in throat) and LIP SWELLING (bottom lip is swollen) in a 55-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 08-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, the patient experienced PARAESTHESIA ORAL (Tingling lips), PHARYNGEAL PARAESTHESIA (tingling throat), LIP PAIN (pain in lips), OROPHARYNGEAL PAIN (pain in throat), LIP SWELLING (bottom lip is swollen) and LIP SWELLING (looks like she got Botox in her lower lip). At the time of the report, PARAESTHESIA ORAL (Tingling lips), PHARYNGEAL PARAESTHESIA (tingling throat), LIP PAIN (pain in lips), OROPHARYNGEAL PAIN (pain in throat), LIP SWELLING (bottom lip is swollen) and LIP SWELLING (looks like she got Botox in her lower lip) outcome was unknown. Not Provided          Treatment He stated she took a vitamin supplement last night for the painful, swollen lip. No concomitant medications were reported.   This case was linked to MOD21-082154, US-MODERNATX, INC.-MOD-2021-090569, US-MODERNATX, INC.-MOD-2021-090584 (E2B Linked Report). This case was linked to MOD-2021-090547 (Patient Link).; Sender's Comments:  MOD21-082154: US-MODERNATX, INC.-MOD-2021-090569:Wife dose 2 case US-MODERNATX, INC.-MOD-2021-090584:wife dose 2 case
This spontaneous case was received from a physician via a company representative regarding a 6 month old (also reported as 11-month-old) male patient. The patient did not have any pertinent medical history, drug allergies/reactions and was not taking any concomitant medications. On 23-OCT-2017, the patient received the first dose of ROTATEQ (dose, unit not reported) (lot# N003978, expiration date: 11-NOV-2018) orally and on 26-DEC-2017, the patient received second dose of ROTATEQ (dose, unit not reported) (lot# N009963, expiration date: 17-NOV-2018) orally for vaccination (immunization). On 26-FEB-2018, the patient received the third dose of ROTATEQ (dose, unit not reported) (lot# N009963, expiration date: 17-NOV-2018) orally for vaccination (immunization) (Drug administered to patient of inappropriate age). On 05-JUL-2018, the patient was brought to hospital because the patient was crying and vomiting. The patient sought medical attention. The patient was treated with an unspecified enema and with air, via tube and was discharged. On 06-JUL-2018, the patient returned to hospital and was operated for intussusception. On an unknown date in July 2018, The patient recovered and the patient was discharged. On 11-JUL-2018, the patient had follow-up visit with the physician and the patient was fully recovered. No lab diagnostics/studies were performed. The causality assessment of the events to the suspect therapy was not reported. The event was considered to be life threatening. No product quality complaint (PQC) was involved. Upon internal review, the event intussusception was determined to be medically significant. This is one of the two reports from the same source. Sender's Comments: US-009507513-1807USA008541.
Slight tenderness at site of injection; The initial case was missing the following minimum criteria: adverse event. Upon receipt of follow-up information on 12Mar2021, this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable consumer (patient's spouse) via the Pfizer-sponsored program. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection), intramuscularly administered in the left arm on 06Mar2021 10:35 (lot number: EL6206) as 2nd dose, single dose for COVID-19 immunization. The patient's medical history and concomitant medications were reported as none. The patient previously received BNT162B2 (lot number: EL9263) intramuscularly, administered in the left arm on 04Feb2021 11:50 as 1st dose, single dose for COVID-19 immunization. The patient had no prior vaccinations. The patient's spouse reported that neither she nor the patient had any side effect from either of the vaccination, (only) slight tenderness at site of injection. The outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.
Pain at site radiating to left thumb, redness, and warm to touch. Symptoms developed day of vaccination. Redness and site warmth have resolved after oral diphenhydramine 3 days post-vaccination. Continues to have pain 4 days post-vaccination.