chrisvoncsefalvay/vaers-outcomes huggingface dataset:
SUSPECTED COVID-19 INFECTION; SUSPECTED CLINICAL VACCINATION FAILURE; This spontaneous report received from a patient concerned a 55 year old white and not Hispanic or Latino male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, and expiry: unknown) dose was not reported, 1 total, administered on 12-APR-2021 to right arm for prophylactic vaccination. No concomitant medications were reported.  The patient had no problems after initial receipt. On 28-AUG-2021, the patient tested positive for Covid (suspected covid-19 infection) (suspected clinical vaccination failure). Patient went to the hospital and received Regeneron and another unspecified medication and was discharged. Number of days of hospitalization was not reported. On 28-AUG-2021, laboratory data included: COVID-19 virus test (NR: not provided) positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable.  The patient had not recovered from suspected covid-19 infection, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Hospitalization Caused / Prolonged). This report was associated with product quality complaint: 90000191386.; Sender's Comments: V0: 20210858502 -covid-19 vaccine ad26.cov2.s- suspected covid-19 infection. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).  V0: 20210858502 - covid-19 vaccine ad26.cov2.s -Suspected clinical vaccine failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS.
Approximately 8 minutes after vaccine patient noted some heart racing, chest tightness and trouble breathing. Given oxygen, symptoms progressed with trouble speaking and throat tightening. Given epi, EMS called, patient monitored and transferred to to EMS.
pt was seen at an urgent care center on 8/27/21 and dx with Strep Throat; treated with Keflex; later developed a cough and loss of smell; pt did a COVID test at home which was positive; pt's workplace had her take another test which was negative; she's now having an increase in SOB with O2 sats 88%; came to ED; found to be positive for COVID, hypoxic, dehydrated and hypotensive; admitted; suffered a spontaneous bleed with left rectal sheath bleeding; treated with multiple blood transfusions; pt's COVID was treated with remdesivir and steroids; O2 supplementation; COVID pneumonia; pt's condition worsened requiring CPAP all the time; decision made for hospice, where she passed away
hot; site is sore; swollen a little; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE WARMTH (hot), VACCINATION SITE PAIN (site is sore) and VACCINATION SITE SWELLING (swollen a little) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (hot), VACCINATION SITE PAIN (site is sore) and VACCINATION SITE SWELLING (swollen a little). At the time of the report, VACCINATION SITE WARMTH (hot), VACCINATION SITE PAIN (site is sore) and VACCINATION SITE SWELLING (swollen a little) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medications were reported.
Redness and swelling at injection site the size of a quarter on day 1.  Two days later developed a blister that opened up and then resolved.  The redness and swelling has continued to increase.  Was given vaccine on 12/23 and came to office on 12/29 with an induration at the injection site of 3 cm with surrounding swelling and redness at largest length of 7.5 cm  by 4 cm.  Area is red, warm to the touch and tender
A non-serious spontaneous report of administration of expired FLUMIST was received from a health professional concerning an eight-year-old female. Neither the patient's past medical history nor the concomitant medications were reported. The product expired on 04-Mar-2012. On 09-Mar-2012, the patient received expired product. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. Additional information was obtained on 18-Apr-2012: the reporter stated that the patient did not experience any late occurring adverse events.
Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: Approximately 20 minutes after vaccine, patient stated she was having some itching and tingling on face and lips. Patient given two diphenhydramine 25mg and stated she was feeling better. Followed up with patient twice after she left and she was feeling better with no symptoms. Advised patient to seek immediate medical attention if needed.
pt is associate I gave pt the covid shot. About 45 mins later she said she felt dizzy and wanted to check her blood pressure. Her blood pressure was 161/101 with pulse 86 right arm. She said she has condition of hyperthyroidism but not taking any meds for it. Then i checked pressure again and it was 164/105 with pulse 85 in left arm. She stayed for 30 mins, then she checked her pressure again with a different pressure machine. This time her pressure was 184/105 with pulse 67 right arm. Then we tried the other machine with consistent elevated pressure of 172/110. She continued to feel dizzy. We called ambulance and they took her to hospital. She is fully conscious when they took her to hospital.
after recv vax 8/95 pt devel ``classic varicella'' 3/98
On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jan-2021, the patient experienced VITREOUS FLOATERS (visual specks in the left eye,Floaters in vision in the left eye). At the time of the report, VITREOUS FLOATERS (visual specks in the left eye,Floaters in vision in the left eye) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Patient took the second dose on 8Feb2021 in the Left arm, Lot number unknown. No treatment medication were provided  No concomitants were provided   Most recent FOLLOW-UP information incorporated above includes: On 23-Apr-2021: Follow up received on 8-FEB-2021 updated reporter details, patient demographics, event dates updated.
COVID vaccine was administered 26 hours after multidose vial had been punctured. Vaccine was stored in temperature controlled vaccine unit. Patient showed no signs of adverse effects after vaccine was administered.
Systemic: Confusion-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Seizure-Severe, Additional Details: Pt was advised to set down in the waiting area for 15 minutes to be monitored, once in a sitting position patient started convulsing into a grand mal seizure, I immedietly ran to him, started restraining him and holding his head to prevent him from hitting the wall, patient was laid flat and restrained by family members and the nurse practitioner, seizure lasted for les than a minute, and patient started to regain consiousness. called 911
SEVERE joint and body aches, shaking chills, fever treatment Tylenol and Advil Outcome resolved in approximately 12 hours
Violent teeth chattering and body shaking for so long my left ear ached and kidneys hurt.  I was freezing but I couldn't move from couch for an hour, then went to bed with clothes on and fell asleep. Woke up 2 hours later and took my evening meds. Still cold but not shaking.  Extremely tired and all of my joints hurt (I have rheumatoid arthritis). None of my symptoms were on the sheet I was given. I almost called a friend to take me to the hospital. I have never had this happen. I have never had any side effects from flu or pneumonia vaccinations. Did I have a seizure? I'm going to call my doctor and report it to the pharmacy.  I don't know if this side effect affected my body and I need to check it out next week. I'm not going to check a box in the next section.
upset stomach; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 01-Jun-2021 and was forwarded to Moderna on 01-Jun-2021.    This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (upset stomach) in a male 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ABDOMINAL DISCOMFORT (upset stomach). At the time of the report, ABDOMINAL DISCOMFORT (upset stomach) had not resolved.            Concomitant medications was not provided.  Treatment medications was not provided.  Action taken with mRNA-1273 in response to events was not applicable.
Woke up with an upset stomach and low grade fever. By 9:00 am while at school fever spiked to 100 degrees. Also, complained about pain in her leg (feels like she has a knot there, even there isn't one that can be seen or felt by hand).   Both her and sister complained about muscle stiffness at injection site.
Dizziness, Headache, Myalgia, Arthralgia, NauseaVomiting Pain and swelling at injection site, Chills, Fatigue Narrative:  Self medicated with tylenol and ibuprofen as needed.
Patient had flu shot on 10/23/2013 and complained about her shoulder pain on 11/9/2013, about 3 wks later. She claimed because the shot was given too high up on her arm close to her shoulder.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. Information regarding relevant medical history and concurrent condition were not reported. On 15-FEB-2016 the patient was vaccinated with an improperly stored dose of PROQUAD (Merck) (lot # L030587, expiration date 10-FEB-2017, dosage and route not specified). It was reported that the vaccine was stored at -13.7 degree centigrade for 15 hours. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
BLE EDMEA/PAIN, GAIT DISTURBANCE, GENERALIZED WEAKNESS PRESENTED TO ER ON 5/1/2021 SYMPTOMS STARTED ON 4/30/2021. SHE WAS FOUND TO HAVE BLE DVT. NO EVIDENCE OF CT PE. REPORTED HAD J&J COVID VACCINE ON 4/6/2021. RECENT HOSPITAL ADMIT FROM 4/28/2021 TO 4/30/2021 WITH ACUTE RENAL FAILURE AND ACUTE CYSTITIS. PT ADMITTED TO MED SURG FLOOR. CALL REC'D FROM PROVIDER NOTIFIING OF RECENT COVID VACCINE AND NEEDED VAERS REPORT COMPLETED.
achiness; headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (achiness) 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 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced PAIN (achiness) and HEADACHE (headache). At the time of the report, PAIN (achiness) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
This spontaneous report was received from a registered pharmacist refers to a 64 years old female. The patient had no pertinent medical history, no drug reactions/allergies. On 24-JUL-2013 the patient was vaccinated with a 0.65ml dose of ZOSTAVAX (lot# J001690, expiration date: 08-MAY-2014), subcutaneous at unspecified location. No concomitant therapies reported. On an unspecified date, the patient who was taking ZOSTAVAX developed redness at injection site that persists. Patient reported to pharmacist that there was no discomfort, and the area of redness had decreased in size. The patient had sought medical attention via pharmacy visit. No treatment was given for redness at injection site. None lab diagnostics studies was performed. At the time of report, the outcome of the redness at injection site was not recovered. Additional information has been requested.
Initial information received on 21-Aug-2018 regarding an unsolicited valid non-serious case received from a non-healthcare professional (office staff). This case involves a 72 years old male patient who was vaccinated with a 0.5 ml dose of FLUZONE HD (lot UI985AC and expiry date: 22-Mar-2019) (route of administration were not reported) in the right arm on 20-Aug-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported. It was a case of actual medication error due to incorrect product storage because shipment of the product was 4 days late (transit for 4 days). This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by the sender: None.
Headache at 8pm on day of vaccine persisting through day 2-3 post vaccine. General malaise intermittently. Left arm pain throughout deltoid for 3 days post vaccine.
Patient received the COVID-19 vaccine on 2/18/21 and 3/17/21, so was fully vaccinated when she tested positive for COVID-19 on 8/15/21.
This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (had Moderna booster and disease symptoms came back) in a 64-year-old male patient 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 VACCINATION COMPLICATION (had Moderna booster and disease symptoms came back). At the time of the report, VACCINATION COMPLICATION (had Moderna booster and disease symptoms came back) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.
After vaccinations received, patient became dizzy, pale, and diaphoretic.  Patient was placed in reclined position with feet elevated, cool compress applied to nape of neck, and patient felt fully recovered after 10 minutes.
5/20/04 Vomited x 10 through night. Shaking. Fever- mom says yes but not taken. Tylenol prn. 5/20/04 no further vomiting (4A). Crying, fussy. Eyes red, nose running clear. Injection site okay. Already had runny nose. 5/21 mom states he just has a cold. No more vomiting.
post herpetic neuralgia; herpes zoster; This spontaneous report was received from a lawyer regarding a case in litigation referring to an elderly female patient (pt) of unknown age. No information regarding current condition, historical condition or concomitant medication was provided. On or about 27-JAN-2015, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (dose details, strength, route, batch/lot# and expiration date were unknown) for long-term prevention of shingles and zoster-related conditions. On an unknown date, the pt was treated by providers for the following injuries resulting from zoster vaccine live (ZOSTAVAX) use: herpes zoster and post herpetic neuralgia. The outcome of herpes zoster and post herpetic neuralgia was unknown. The lawyer considered herpes zoster and post herpetic neuralgia to be related to zoster vaccine live (ZOSTAVAX).
The first two days, I was fine besides my arm hurting. Starting on Friday, there was some discomfort under my armpits.  I'm prone to anxiety - so on Friday night I was extremely anxious and didn't sleep until 3am. On Saturday, the armpit pain became worse especially at night.  Again didn't sleep until 4am. There is swelling and pain still on Sunday morning.  I've iced and put a warm compress on them which is helping slightly but the swelling and pain is still there.
Patient started running a fever about 1pm after she received the injections. Fever was 102.8 F rectally and required TYLENOL. Fever was 103.6 F that night at 11pm. Baby was very fussy and continued to run high fever for 3 days after immunizations.
Experience slight numbness in feet and lower legs beginning 3/27/21 that progressed over time. Shingles rash and diagnosis 6/1/21. Numbness in feet and lower legs persists as of this submission 7/1/21.
Initial information received on 17-Aug-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 2 months old male patient who was vaccinated with only liquid portion of a 0.5 ml first dose of PENTACEL (Batch number: C5408AB and expiry date: 06-Oct-2019) via intramuscular route in right thigh on 10-Aug-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant medications given. It was a case of actual medication error due to inappropriate reconstitution technique because only liquid portion of PENTACEL given, HIB portion not given due to error. It was unknown if any adverse event was occurred or not following the vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by the sender: None.
Fatigue started around 3-4 hours after initial dose and lasted for the rest of the night. Had to lay down because I felt exhausted around 7pm. My arm where the injection site was became incredibly sore to the point where I couldn?t sleep on it at all.  Otherwise I felt decent. I woke up the next day and my arm was about 50% as sore as it was at the peak. I had about 90% energy level so still very slight fatigue. Towards the end of the night the soreness in my arm dropped to about 20% of the peak.
Subsequent to two doses of varicella virus vaccine live, serum antibody test showed negative seroconversion.
1:30 PM client into clinic states she had to go to ER past Fri. 02/24/06 neck and left arm numb with shooting pains going down arm. ER doctor did x-rays but didn't not see anything on x-ray. ER Doctor states she had reaction to Td given on 2/10/06. She should not received any more Td in her lifetime. Client went to her PCP and she confirmed what ER doctor said on 2/27/06 no redness or swelling noted.
My face and particularly forehead broke out with red lesions; My face and particularly forehead broke out with red lesions; Acne outbreak; This case was reported by a nurse and described the occurrence of acne in a elderly patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced acne, skin lesion and erythema. On an unknown date, the outcome of the acne, skin lesion and erythema were unknown.   It was unknown if the reporter considered the acne, skin lesion and erythema to be related to Shingrix.  Additional details were reported as follows: The case was reported by nurse who was patient. The age at vaccination was not reported. The patient reported that the after taking first injection of Shingrix, the patient's face and particularly forehead broke out with red lesions all over the rest of face but the forehead was specially.  The patient asked if this was a very common side effect . The Alfie hydroxide face cream usually had cleared this up but now it looks like an acne outbreak.  The patient did not normally have acne the patient was really surprised that the patient's face reacted to the anti shingles shot.  The patient asked if GlaxoSmithKline could provide any more information on this events.
her arm hurt with the previous doses too; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  An 83-year-old female patient received bnt162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization, reaction(s): "her arm hurt with the previous doses too". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "her arm hurt with the previous doses too".  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-202300348067 Same patient, different vaccine dose number, different AE;