chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Not an adverse reaction, but administration error. Patient came in for a Pfizer COVID bivalent booster and was given an original Pfizer COVID vaccine in error.
Clinical varicella in patient who received the varicella vaccine. Patient had rash, itching and fussiness for about 1 week.
Patient received TD-171 on 01/25/08.  He developed flu-like symptoms, including cough, ear pain, pharyngitis, and muscle aches, and a local reaction at the injection site of redness and induration, with a macule and returned to the doctor on 01/29/08.  The local reaction size was 50 x 75 mm.  The local reaction was not itchy.  Patient had a follow up visit scheduled by "refused to come back".  There will not be any additional attempts to obtain follow up information.
she was administered the first dose of Pfizer COVID-19 Vaccine and later got COVID-19; she was administered the first dose of Pfizer COVID-19 Vaccine and later got COVID-19; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect. A contactable female physician (patient) of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported), via an unspecified route of administration from an unspecified date in 2020 at a single dose for Covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date in 2020, the patient got the first shot of COVID vaccine and got COVID, she was wondering if she should still get the dose scheduled for 04Jan2021. The patient clarified that she is both a medical doctor/physician as well as the patient. She clarified that she was administered the first dose of Pfizer COVID-19 Vaccine and later got COVID-19. She called to ask if she should still get the second dose of COVID-19 Vaccine which is scheduled for 04Jan2021. She clarified that she does not think anything went wrong with the COVID-19 Vaccine. She does not think her receiving the COVID-19 Vaccine and developing COVID-19 are related; there was no way she would have had time to develop any protection from the COVID-19 Vaccine at the time she was exposed to COVID-19 2 days later. She does not think she can provide any relevant medical information that would be helpful for this report and declined to continue report. The outcome of the event was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: The reported "developing COVID-19" after COVID-19 immunization is considered ineffective of BNT162B2, and the Company cannot completely exclude the possible causality between the reported event and BNT162B2 administration.
Swollen lymph node in right axilla. Believe this appeared ~1-2 days following initial vaccine administration and has persisted with fluctuating size course and variable tenderness to palpation. Continues to be present at current date (still obtained Dose #2 and Booster Dose).
No adverse event; Received a full dose for the 2nd booster instead of a half dose because he has an autoimmune disease; This spontaneous case was reported by a patient and describes the occurrence of INCORRECT DOSE ADMINISTERED (Received a full dose for the 2nd booster instead of a half dose because he has an autoimmune disease) and NO ADVERSE EVENT (No adverse event) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 055A22A, 065F21A, 012A21A and 012M20A) for COVID-19 vaccination.     Concurrent medical conditions included Autoimmune disorder and Cancer.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Aug-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Aug-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INCORRECT DOSE ADMINISTERED (Received a full dose for the 2nd booster instead of a half dose because he has an autoimmune disease). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INCORRECT DOSE ADMINISTERED (Received a full dose for the 2nd booster instead of a half dose because he has an autoimmune disease) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            No concomitant medications were reported.  Doses patient received on 14-Nov-2021and 18-Aug-2022 were first and second boosters respectively.  Patient confirmed with the pharmacist that patient received a full dose for the 2nd booster instead of a half dose because patient had an autoimmune disease and had a history of cancer.  No treatment medications were reported.   This case was linked to MOD-2022-630567 (Patient Link).
Pt had a 9" x 4" hard raised area that was warm to the touch with redness, several hard blisters in center at VARIVAX site.
Hypertension; chest pain; Dry cough; This is a spontaneous report from a contactable consumer(patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot and expiry were not reported), via an unspecified route of administration, administered in deltoid left on 28Apr2021 as dose number unknown, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient had chest pain and was found to have hypertension in 2021. Linsopril started. Switch to losartan due to side effect of dry cough in 2021. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Fingers tingling; Arm hurting on the sa; Arm pit hurting; This spontaneous case was reported by a patient and describes the occurrence of PARAESTHESIA (Fingers tingling), PAIN IN EXTREMITY (Arm hurting on the sa) and AXILLARY PAIN (Arm pit hurting) 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PARAESTHESIA (Fingers tingling), PAIN IN EXTREMITY (Arm hurting on the sa) and AXILLARY PAIN (Arm pit hurting). At the time of the report, PARAESTHESIA (Fingers tingling), PAIN IN EXTREMITY (Arm hurting on the sa) and AXILLARY PAIN (Arm pit hurting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported by the reporter. No treatment medications were reported by the reporter.
Massive PE with R heart strain. Possible RA thrombus. Duplex LE with extensive residual B/L lower extremity clot. Was given heparin and needed tPA due to high risk for decompensation. Transitioning to Eliquis
improperly stored PROQUAD that was administered; This spontaneous report has been received from a nurse referring to a currently 1 years old patient of unknown gender. Information about concomitant therapy, pertinent medical history or drug reactions/allergies was not provided.  On an unknown date, the patient was administered improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (strength, dose and route were not reported; lot # T003833 and expiration date 01-AUG-2021) for prophylaxis (product storage error).   The administered doses of the vaccines experienced a temperature in the range -14 degree Celsius to -10 degree Celsius (-11.84 degree Celsius) for 45 minutes and a temperature in the range -9 degree Celsius to 8 degree Celsius (-4.12 degree Celsius) for 30 minutes recorded by a data logger. There was no previous temperature excursion.
Arm soreness, headache, chills, achy joints, lethargy, starting 12 hours after innoculation
My daughter has experienced 2 seizures. This occured 6 weeks after gardisil vaccine.  She has never had any health problems prior to this event. 12/18/07-records received-for DOS 12/8/07-DC DX: New-onset seizures. Urinary tract infection, on treatment. New-onset seizures twice with postictal confusion and amnesia. Generalized tonic clonic seizure.
Day 1 through 4 - Pain at injection site Day 7 to present (day 10) - intense itching, pain, redness, warmth, and swelling about egg-size at injection site
On 6APR92 prev well, picked up from sitter noted feeling very warm, cranky; @ home t105 put in tub then started to have generalized seizure activity 10-15 mins; post-ictal in ER otherwise no neuro deficit; adm-no further sz; mild rash
12 days following the vaccine administration I noticed redness on my arm around the injection site. This redness was hot to the touch and rather large, exceeding the deltoid muscle and going down into my bicep. I also felt radiating soreness into my armpit and left breast.  The following day the rash had grown in size and felt hot to the touch on my entire upper arm with swelling and edema that affected the movement of my arm and hand. Continued soreness and pain in my armpit, left breast and down my arm into my fingers and up into my neck.  I proceeded to go to the urgent care as directed by Clinic employee health and my PCP. There was I was diagnosed with cellulitis and prescriped Keflex for 7 days, 3x a day.  It has been recommended that I seek further medical care due to my reaction, but this has yet to be scheduled.
Severe soreness under left arm (armpit) I am just taking ibuprofen for pain.
Patient received Flublok vaccine on Tues 10/20/2020 aroung 6:15PM. Patient called to inform pharmacy of armpit swelling and minor discomfort on Thursday morning at 10:15 am 10/22/2020. There is very minor redness not very noticeable at actual injection site. This is the first time this has happened to patient. Patient was inform if condition worsens or does not resolve in 2 to 3 days to contact pharmacy and reach out to primary care as needed.
Patient was 12 years old and given Pfizer 5 to 11Year old vaccine.
Pt recv vax on 5/27/98; on same dy pt exp redness &swelling (> 1in.); tenderness >24 hrs.  As of 7/7/98 pt imp.
Pt experienced conjunctivitis 1 day post vax. 48 hours later pt developed a high fever of 106, febrile seizure, taken to ER. Pt was very sick for 2 days. 10 days later the pt broke out in measles type rash lasting approximately 10 days.
Moderna COVID-19 Vaccine EUA  Rash, itching along various places on my body:  left side of neck, elbow bend (both arms), thighs (both), left shin, left ankle, palm of hands (both), scalp, cheeks, chin, and lips
8 hours after the flu shot I developed chills, high fever, body aches, headaches, and a cough. At the site of the injection is a 3 inch band of redness that is swollen and hot to the touch. The pain runs from my collarbone and wraps around my left armpit. Today, being the third day, my fever is just below a hundred. The highest was 103. My home treatment has been ibuprofen every 4 hours and cough syrup. Over the years I have had many flu shots and this is the first bad reaction I have experienced. I would like to know if this is common for this years influenza vaccine. My doctor says no one in her practice has complained of symptoms like mine.
Nurse states vaccine leaked out of the patient's right arm during ID administration; patient did not receive a full dose.  The same nurse repeated ID administration on the same arm (right arm) successfully. No patient complications noted.
3/30/21--approx 30 min post Janssen vaccine,  in observation area,  diffuse rash on upper arms, chest, hands, itchy. Denied breathing difficulties, Onsite FNP assessed client, breaths WNL, O2-96%RA, BP elevated 154/94, P-80. NKA, Benadryl 50mg/Claritan 10mg po taken. Ct observed 1hr post vaccine, 30" after rash noted, BP 134/86, P-78, no worsening of rash, no breathing difficulties. Ct made aware if rash increased, or difficulty breathing to go to ER.
The patient was given 0.2ml dose from the Pink cap vial of Moderna. This was the incorrect vial and dosage. Should have been given 0.25 ml from the blue cap vial of Moderna. This was the patients first dose of Moderna COVID vaccine. Patient will need to restart the series per PCP.
Hard time sleeping; Lacks full breath; Feels fatigued; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Hard time sleeping), DYSPNOEA (Lacks full breath) and FATIGUE (Feels fatigued) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     The patient's past medical history included Lung cancer and Polio.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced INSOMNIA (Hard time sleeping), DYSPNOEA (Lacks full breath) and FATIGUE (Feels fatigued). At the time of the report, INSOMNIA (Hard time sleeping), DYSPNOEA (Lacks full breath) and FATIGUE (Feels fatigued) had not 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.
This initial spontaneous report was received from an approximately 79 year old male patient referring to himself. Medical history, concurrent conditions, and concomitant medications were unknown. The patient had no drug reactions/allergies. In 2017, the patient received an unspecified shingles vaccine and sterile diluent (manufacturer not specified; dose, route, and lot #'s not reported). On an unspecified date, he developed shingles in his right eye resulting in a loss of vision in the eye. The patient saw an Optometrist for the event and received unspecified treatment. The patient was not hospitalized. No labs or diagnostic studies were performed. The event was not resolved. Causality assessment was not provided. The patient requested compensation for his inconvenience. Upon internal review, shingles in his right eye resulting in a loss of vision in the eye was considered to be medically significant. Additional information has been requested.
Passed out; Bruised head; Head bumps; Diarrhea; Dehydration; Hives between fingers; Gastritis really bad/Gastritis after the vaccine; Too sick to get up out of the chair/Sick since having covid in November; Fell once but caught herself; Weak; Could not get up and down; Gas goes up in the head and neck and shoulder; pain from gastritis; Not yet received her 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042B21-2A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in November 2020. Concomitant products included OMEPRAZOLE MAGNESIUM (PRILOSEC [OMEPRAZOLE MAGNESIUM]), LISINOPRIL and METFORMIN for an unknown indication.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (Passed out) (seriousness criterion medically significant), CONTUSION (Bruised head), SKIN LESION (Head bumps), DIARRHOEA (Diarrhea), DEHYDRATION (Dehydration), URTICARIA (Hives between fingers), GASTRITIS (Gastritis really bad/Gastritis after the vaccine), ILLNESS (Too sick to get up out of the chair/Sick since having covid in November), FALL (Fell once but caught herself), ASTHENIA (Weak), MOBILITY DECREASED (Could not get up and down), FLATULENCE (Gas goes up in the head and neck and shoulder), ABDOMINAL PAIN UPPER (pain from gastritis) and PRODUCT DOSE OMISSION ISSUE (Not yet received her 2nd dose). At the time of the report, LOSS OF CONSCIOUSNESS (Passed out), CONTUSION (Bruised head), SKIN LESION (Head bumps), DIARRHOEA (Diarrhea), DEHYDRATION (Dehydration), URTICARIA (Hives between fingers), GASTRITIS (Gastritis really bad/Gastritis after the vaccine), ILLNESS (Too sick to get up out of the chair/Sick since having covid in November), FALL (Fell once but caught herself), ASTHENIA (Weak), MOBILITY DECREASED (Could not get up and down), FLATULENCE (Gas goes up in the head and neck and shoulder), ABDOMINAL PAIN UPPER (pain from gastritis) and PRODUCT DOSE OMISSION ISSUE (Not yet received her 2nd dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information not provided by reporter.    For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Company Comment  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. Further information has been requested.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: 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. Further information has been requested.
Chills began approximately nine hours after injection; temperature normal; treated with ibuprofen and sleep. Following morning fever rose to 101 F, chills persisted, with widespread muscle aches and general torpor. Treated with acetominophen. Vomited once at approximately 9:30 a.m. Fever and chills ended approximately 26 hours after vaccination. Extreme fatigue/torpor persisted until roughly 52 hours post vaccine. Condition normal by 60 hours post vaccine.
Per the DOH we were advised to enter same date as administered for the adverse event, but no adverse event took place.
Lethargic; Weak; Flu-like symptom; He experienced after getting the third dose of Moderna vaccine and he also added that he's not an immunocompromised patient.; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (Lethargic), ASTHENIA (Weak), INFLUENZA LIKE ILLNESS (Flu-like symptom) and EXTRA DOSE ADMINISTERED (He experienced after getting the third dose of Moderna vaccine and he also added that he's not an immunocompromised patient.) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 066D21A and 070A21A) for COVID-19 vaccination.     Concomitant products included LISINOPRIL, ACETYLSALICYLIC ACID (ASPIRIN 81), ATORVASTATIN CALCIUM (LIPITOR), BUPROPION, TADALAFIL and ZOLPIDEM for an unknown indication.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Aug-2021, the patient experienced LETHARGY (Lethargic), ASTHENIA (Weak), INFLUENZA LIKE ILLNESS (Flu-like symptom) and EXTRA DOSE ADMINISTERED (He experienced after getting the third dose of Moderna vaccine and he also added that he's not an immunocompromised patient.). On 16-Aug-2021, EXTRA DOSE ADMINISTERED (He experienced after getting the third dose of Moderna vaccine and he also added that he's not an immunocompromised patient.) had resolved. On 17-Aug-2021, LETHARGY (Lethargic), ASTHENIA (Weak) and INFLUENZA LIKE ILLNESS (Flu-like symptom) had resolved.            No Treatment information  were reported.
This spontaneous report was received from a physician via market research program conducted by agency refers to a female patient of unknown age. On an unknown date in 2012, the patient was vaccinated with a dose of ZOSTAVAX. On 31-MAY-2015, the patient subsequently developed shingles. The patient began VALTREX. The outcome of the event was reported as recovering/resolving. The reporter considered the event to be related to ZOSTAVAX. Additional information has been requested.
Mother reported one episode of hematochezia one day post ROTATEQ arm. Mom will opt out for future doses of ROTATEQ.
currently had a pap with positive HPV; currently had a pap with positive HPV; This spontaneous report was received from a registered nurse referring to a female patient of unknown age.  Information about medical history, concurrent conditions and concomitant therapies was not provided.      On an unknown date, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) (strength, dose details, route, lot # and expiration date were not reported) for prophylaxis. On an unknown date, the patient currently had a pap with positive human papilloma virus (HPV). The outcome of the events was unknown. The causality assessment was not reported.
Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) and CHILLS (Chills) 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever) and CHILLS (Chills). At the time of the report, PYREXIA (Fever) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Pt sneezing, face red, no breathing difficulty.  Mom gave a dose of BENADRYL + advised to observe.
I went to an ENT because my tongue was tingling which was concerning to me. The doctor referred to it as geographic tongue. But I have never had this happen before and have not experienced it since. The whole thing lasted probably about 6 months. Also, a few months after the vaccine I started having problems with one of my front teeth. I ended up having a severe infection that resulted in me having the tooth removed.
Red rash from shoulder to elbow on right arm. Somewhat sore, but not too uncomfortable. Rash appeared one week after injection and went away ten days after first appearing.
ON 07-12-07 RECEIVED TDAP AND ON 07-13-07 - RIGHT DELTOID AT INJECTION SITE NOTED WITH REDDNESS, PAIN, LIMIETED ROM, FEVER, H/A, AND NODULE RIGHT AXILLARY AREA.  ON 07-16-07 SEEN VIA PCP
Frequent periods (2 periods/month) then late period. Fever of 101+ for 24 hours, chills, nausea, dizziness. Arm soreness for 1 week after.
Case was fully vaccinated with COVID 19 vaccine. Last dose administered on 2/5/21. Case tested positive for COVID 19 on 8/4/2021. and was admitted to Medical Center with covid signs and symptoms on 8/11/2021. Case expired while still hospitalized on 8/26/2021.
Fever of 101.4 degrees started 10/21/10 approx 3AM, left arm at sight of shot was extremely sore for 9 days. Fever continued & on 10/25/10, went to doctor. Arm was examined & doctor determined I was possibly injected with a contaminated needle. 10-day antibiotic prescribed. Fever continued until 10/29/10. Cost $75 - dr. antibiotic - $8.42 = $83.42.  I should be reimbursed for doctors & drugs.
Fever 103.2, Severe Redness, Severe Soreness, Swelling, Severe Itching and Severe Heat at the site of the injection and Severe leg pain.
Pt. RTC 11-5-15. Pt. reported (L) upper outer arm was red/swollen since 11-3/11-4 at 5p 11-3-15 after immunization. On exam pt. (L) upper arm red/swelling. Pt. reported taking BENADRYL, ZANTAC and ibuprofen, cold compress as ordered per Dr. at office visit. Pt. will continue to monitor and call office as needed.