chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient had a tingly tongue which eventually became swollen and resulted in her not being able to swallow.
Approx. time of injection 1215 - pt returned at 1250 with complaints of increased pulse, shortness of breath, red face/arms and itching - slight cough - (had nasal allergies) took BENADRYL at 1240 stayed close to nurse until 1430 - feeling much better and left.
Developed daily persistent myalgias two days after COVID-19 Pfizer Vaccine booster.  Was ultimately diagnosed with PMR by rheumatologist.
pt recv vax in 1995; in 1995 pt exp fever, total body rash, abd pain, loss of appetite, irritability & fatigue; No further details were provided;
Six hours post vax, the pt broke out in fever of 101, ached all over, pale; lasting 6 hours.
-Patient experienced pain in the shoulder that did not go away for 2 months.  -Ibuprofen 600 mg, Cyclobenazeprine 5mg, Tizanidine 2mg
My symptoms started 06/26/2022 around 11:00PM with  chills  and I felt very very tired. I was flying out on a plane and I fell asleep before the plane taking off, when I woke up I was still tired and felt very sore.  Later that day I noticed lots of congestion, and I started to feel warm in the afternoon around 99. I took a COVID-19 test at night and it was positive. The next day my fever was about 100, congestion and fatigue continued. I was mostly tired with a stuffy nose and I slept a lot.
Patient contracted COVID-19 after receiving 2 COVID-19 vaccine doses (Pfizer) and was admitted to the hospital for treatment and is still an inpatient currently. Patient admitted with hypoxic respiratory failure on 3/25/2021 for severe COVID-19. Patient is s/p convalescent plasma on 3/26, and s/p remdesivir 3/26-3/30. Received tocilizumab x 1 dose prior to intubation. Patient with persistent respiratory failure/ARDS requiring intubation. Course further complicated by CMV viremia as well as shock with rising procalcitonin concerning for superimposed bacteria pneumonia as respiratory culture is growing Enterobacter. Goals of care conversations occurring with ICU team and family.
abnormal EKG within a month of 2nd dose Allergic reaction to skin on chest same month of the shot hyperthyroid, Graves Disease, and Hashimoto as well as a heart murmur in August 2021
Patient has chronic tinnitus. Tinnitus significantly worsened later on the same day of vaccination. The increased severity of tinnitus has persisted.
Nose bleed; This is a spontaneous report from a contactable consumer (patient himself).   A male patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0187), via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient's previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: ER8736) via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunization. On an unknown date after receiving second dose of the Pfizer vaccine (reported as on Friday), the patient experienced nosebleed and since then he has three (times) nosebleed and want to know if there are any reports of that being a possible side effect from the people. After he had his first dose about a week later, he had 2 times nosebleed, so he doesn't know if this is the side effect from the vaccine. The outcome of the event was unknown.  Follow up attempts are needed. Further information has been requested.
fever 103 R 1st 24 hrs p/shot; t102 next 24 hrs; APAP given; pt cried high pitched 2-3 hrs @ time x 10 times; tx DT @ 4 months;
booster dose due to previous 2 doses of Pfizer shows Zero antibodies in his system
Information has been received from a nurse practitioner concerning a now 40 yr old male who was vaccinated with measles virus vaccine live  (Moraten) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3)  as a child (lot not available). On 26Apr04 the pt's MMR titer was neg for mumps. Follow up information from the reporter revealed that the pt's early medical records were not available. Additional information is not expected.
Booster; Covid-19 just the positive/ still got very badly sick with the Covid-19; Covid-19 just the positive/ still got very badly sick with the Covid-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer) for a Pfizer sponsored program (159558).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: IMMUNISATION (medically significant), outcome "unknown", described as "Booster"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Covid-19 just the positive/ still got very badly sick with the Covid-19". The reporter's brother took the 3rd injection and still got very badly sick with the Covid-19. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive, notes: Covid-19 just the positive.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Vaccine given 12.31.19 Symptoms started 1.1.20 - hot and tender area on back of left arm (where vaccine was administered) Today 1.2.20 - symptoms have worsened. Arm has two red inflammed and hot circles around the injection site, fever, malaise, headache.
Patient and mother here with complaint of noted increased redness, swelling to left thigh - very warm to touch - hurts - Mom reports - noted redness - pain the AM after injection given.
Flat red rash from neck to abdomen on the front of my body; Rash; Dose number: 3, product: COVID 19, brand: Pfizer; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 09Dec2021 15:45 (Batch/Lot number: unknown) at the age of 44 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2), when the patient was 44 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1), when the patient was 44 years old, for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 09Dec2021 15:45, outcome "unknown", described as "Dose number: 3, product: COVID 19, brand: Pfizer"; ERYTHEMA (non-serious) with onset 11Dec2021, outcome "not recovered", described as "Flat red rash from neck to abdomen on the front of my body"; RASH (non-serious) with onset 11Dec2021, outcome "not recovered", described as "Rash". Therapeutic measures were not taken as a result of erythema, rash.  Additional information: No other vaccine in fourweeks. 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.
Child vomited 2 hours after admin. of vaccine. Took 10 min rest, ate 2 plates of pasta at 7pm with out ill effects.
Developed right shoulder  and left collar bone swelling . Patient also complained of pain to area. Symptoms developed approx. 24 hrs. post 2nd Pfizer dose. A few days later patient reported memory issues that were unlike. Could not remember her husbands birther day, wedding anniversary or the nuts she bought from a Hazelnut stand she frequents. She recalled these things 48 hours later which prompt her to notify her healthcare provider's office.
Initial and follow-up information has been received from a nurse concerning a 14 year old female who on 10-JUL-2009 was vaccinated intramuscularly with the first dose of GARDASIL (LOT# 662404/0312Y). On 11-JUL-2009 the patient experienced rash, itching, angioedema around eyes, swelling of eyelids and swelling of her face. On 11-JUL-2009 the patient woke up with puffy lower eye lids and itching all over her body. The patient sought medical attention by phone call and the physician instructed her to take BENADRYL three times a day for one week. Subsequently, the patient recovered within a few days. No further information is available at the time of this report. Follow-up information has been received from a physician concerning the 14 year old female with no drug allergies and no pertinent medical history who on 10-JUL-2009 in the AM was vaccinated intramuscularly with the first dose of GARDASIL (LOT# 662404/0312Y). The patient had no illnesses at the time of vaccination. In the evening (previous reported was on 11-JUL-2009), the patient felt itchy, but no rash developed. The next day, on 11-JUL-2009, the patient's both low eyelids were swollen, face and eyes were pruritic. The patient had no fever, no rash and no difficulty breathing.  he patient's mom was advised to give BENADRYL, PO, three time daily (TID). On 11-JUL-2009 the patient had recovered. No further information was expected.
Breakthrough case admission after 3 vaccines Pfizer 3/27/21 Lot# ER8734;  Pfizer 5/7/21 Lot# Ew0179; Pfizer 1/5/22 Lot# FL3198
About 2 weeks after the 2nd dose, I started experiencing a lot o hip pain in my right hip. It got worse to the point where I could barely walk I went to an urgent care where they did x-rays and found arthritis and inflammation in ONLY the right hip. They gave me a prednisone shot. I got a bit of relief for about 10-14 days. Then the pain came back just as bad. I was sent from MRI where it said moderate to severe right labral tears. Tendinosis of gluteus minimus tendons. They sent me to an orthopedic surgeon who thought I had the arthritis for years, but the vaccine might've caused inflammation which triggered it. I did a month of physical therapy and took OTC Advil. I also used voltaren cream. I was put on fish oil 1x/day and my Osteo Biflex was increased to 2x/day. I also used Icy Hot. I did not have to use any narcotics. With all of this, it has gradually gotten better. It is better now than it was, the most acute was in April and May. In June, it began it get better. I am now back in the gym doing all my normal activities. I cannot do long walks.
Patient  Male, 81-year-old, 7/19/1939  Admitted 5/16/2021  Admitted with femur fx after a fall.  COVID-19 PCR positive 5/16/2021  No indication that he is from a Nursing Home, etc.
5days p/vax pt devel fever 104f x2 days; light papular rash face, rhinorrhea; occasional cough w/emesis
Post vax, the pt developed hair loss and stopped growing. He aches in his right hand and wrist.
Large area of erythema from vax site. Itchy. No fever. No N/V
Fever, cough, sore throat, congestion, headache, body chills, achey
One hour post vax, the pt experienced hives. The most recent information received reports the outcome of the event as resolved.
The event is a medication error. The patient received a third dose of Janssen instead of a mRNA as a booster. 3/12/21 Janssen 11/3/21 Janssen 04/6/22 Janssen
injection site pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (injection site pain) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 20-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Feb-2021, the patient experienced VACCINATION SITE PAIN (injection site pain). At the time of the report, VACCINATION SITE PAIN (injection site pain) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported by investigator  No treatment medications provided by the reporter.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.
Administered expired vaccine; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Nov-2021 at 1:00 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine). On 28-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine) had resolved.            No Concomitant medication was reported.     No treatment medications were reported.   This case was linked to MOD-2021-398840, MOD-2021-398858 (Patient Link).
8-8-02  Noted approximately 3" X 3" area of erythematous edema to Rt. deltoid area.  Child denies complaints of discomfort.  Encouraged parent to apply cold packs to site and monitor over weekend.  Child's mother verbalized her plan to administer OTC Tylenol and Benadryl to the child when they got home today for redness, swelling, and discomfort.  Mother to report to health center via phone on Monday 8-12-02 for follow-up.  Questions were encouraged and answered.
Patient some swelling and pain 24 hrs later. 72 hrs later had MD check and decide a mild reaction.
No adverse event; patient was vaccinated after the expiration date; This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient was vaccinated after the expiration date) and NO ADVERSE EVENT (No adverse event) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066K21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Jul-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 15-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient was vaccinated after the expiration date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient was vaccinated after the expiration date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (patient was vaccinated after the expiration date).    Concomitant medications details were not reported by the reporter.  Reportedly, at the time of unannounced visit by an representative on 28-Sep-2022, 50 doses of moderna vaccines were left in the health department which were looked well but later on the day stated that were uncompliant due to the same lot of moderna vaccines had expired on 07-Jul-2022.  Additionally it was mentioned that the expiration code on the packaging slip was not the expiration code, had to scan the QR code to determine the actual expiration code, thus failed to did by not reading carefully the packing slip.  Treatment details were not reported by the reporter.
Injection site swelling; Numbness on the left side of the face; Left facial tingling; A spontaneous report was received from a Health Care Professional concerning a 59-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced tingling on the left side of the face, numbness on the left side of the face and swelling on left arm.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 06 Jan 2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (0Batch Number: 25L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 06 Jan 2021, the patient experienced tingling and numbness on the left side of the face and subsided after 3hrs. On 07-JAN-2021, the patient experienced swelling on left arm that got worse for over 2 weeks before it goes away.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.     The outcome of events tingling and numbness on the left side of the face was considered resolved(subsided after 3hrs) on 06 Jan 2021. The outcome of event swelling on left arm that got worse for over 2 weeks before it goes away was considered resolved.; Reporter's Comments: This case concerns a 59-year-old female who experienced serious unexpected events of Hypoaesthesia along with a NS unexpected event of Paraesthesia and NS expected event of Vaccination site swelling.  The events occurred the same day as the first dose of mRNA-1273. Treatment not reported. Event outcomes resolved. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-024023:Crosslink case - same reporter US-MODERNATX, INC.-MOD-2021-024023:Crosslink case - same reporter
19 yo medically complex M with prior COVID infection in Dec 2020 who received first dose of the Moderna COVID vaccine on 3/4 as well as Epo shot (for chronic anemia secondary to CKD). Recently admitted for MRSA sacral abscess and had recently been discharged to complete treatment on oral Bactrim. On 3/6, developed worsening diarrhea, decreased urine output, facial and tongue swelling, and altered mental status. EMS was called and patient was brought to the  ED. Upon presentation, noted to have hypotension and was fluid resuscitated. Initial blood gas with hypercarbia, and he was intubated for airway protection. CXR was non-focal. He was started on empiric vancomycin and ceftriaxone, although these were discontinued with negative blood and urine cultures. Repeat respiratory film array was negative. Patient intubated 3/6-3/10.
Within 4 minutes of injection started developing hives on the face, neck, arms, abdomen, and the bottom of the feet. Was administered 50 mg of Benadryl PO, development of hives slowed down. 4.5 hour later hives returned, was instructed to take another 50 mg of Benadryl and continue q6h, instructed to take famotidine 20  mg po q12h, physician on site also prescribed 60 mg prednisone PO qday x 5 days. Then continues to have increased HR that evening and through current resting HR averages 110 and walking HR averages 133.
This spontaneous report was received from a registered pharmacist refers to a male patient of unknown age. Approximately on 06-SEP-2013 (reported as 10 days ago) the patient was vaccinated with a dose of 0.65 milliliter (ml) ZOSTAVAX (lot #, expiration date unknown), subcutaneously. The client was ordered a prescription for an antiviral but the prescription has not been filled. Pharmacist stated the client usually got an antiviral medication as prophylaxis therapy for cold sores. However pharmacist stated she did not know if the patient had an active ace of cold sores at the time of this report. The outcome of cold sores was unknown. Causality was not reported. Additional information is not expected.
Pt complained of dizziness and appeared lethargic. Stated he felt short of breath. Nurse gave client an ice pack on his neck. Vitals: BP 140/100, HR 73 and reg, RR 18. Pt stated he has a cardiac condition and when he feels like this he goes to the ER, he requested transportation to ER. EMS was called and they arrived at 11:15. Client had no shortness of breath, wheezing or discomfort at this time. He was lethargic but arouses to verbal stimulation. Was oriented to person and DOB. Transferred to hospital via ambulance at 11:20 am. Was stable at this time.
At 8 pm that night, I had aches and a 100 degree fever. By 2 am the following morning, I had a 102.7 fever, aches, arm soreness, shortness of breath, headaches, and chills. By 8 am, fever was down to 100, still had headache. By 2 pm, fever was 99, and by 7 pm fever and headaches were gone.
Lethargy, poor feeding with decreased po intake, and respiratory insufficiency resulting in prolonged ICU hospitalization with mechanical ventilation.
Around 3/9/2021 at about 10 PM, my left arm began itching around the injection site. On 3/10/2021, my had reddened and was warm to the touch and painful. On 3/11/2021, I went to my PCP, who diagnosed me with cellulitis. He prescribed me antibiotics and advised me to seek further help if the situation did not improve. On 3/12/2021, the redness on my arm continued to spread from the acromial area towards about 4 inches above the elbow. It also spread laterally and down the middle. On the night of 3/12/2021, I went to the ER at Hospital. Bloodwork was done, and I was again diagnosed with cellulitis. I was given an antibiotic and told to keep an eye on it. The situation started to improve about 2 days later and it was fully resolved about a week later.
Information has been received from a woman in a medical office concerning a 10 year old male patient who on 6/29/95 was vaccinated with a dose of varicella virus vaccine live. On 4/12/04, the patient developed chicken pox. Medical attention was not sought. Subsequently, the patient recovered. The reporter also mentioned five other patients who developed chicken pox post vaccination with varicella virus vaccine live (WAES0407USA00537, 0407USA00539, 0407USA00540, 0407USA00542, and 0407USA00548). Additional information is not expected.
Case number PHEH2013US018977 is an initial spontaneous report received from a nurse on 05 Sep 2013, with a follow up received on 10 Oct 2013. This report refers to an 18-year-old female patient. Her medical history and concomitant medication were not reported. Her vaccination history include administration of meningococcal vaccine (manufacturer and batch number unknown) on 13 Nov 2007, which she was well tolerated. She was vaccinated with MENVEO (batch number: A12009, expiry date: 28 Feb 2014) in the left deltoid at a dose of 0.5 ml intramuscularly on 15 Aug 2013 at 01:00 pm. It was reported that MENVEO which reached 31 Fahrenheit for 3 das was subsequently administered to the patient. No adverse event was reported following this medication error. Follow up was received from nurse on 10 Oct 2013: Updated patient demographics, vaccination history, site and time of vaccination.
Since receiving her shots she was very tired (which i figured was normal) but since she doesn't smile, laugh, goo, or baby talk as much as she used to. She is just quiet & sits there unless she is fussy & crying which is more frequently as well.