chrisvoncsefalvay/vaers-outcomes huggingface dataset:
broke out in hives; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date as unknown single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took ixekizumab (TALTZ) for psoriasis and was allergic. Caller was allergic to psoriasis medication called Taltz injections. She broke out in hives, and went to emergency room. Caller asking if ingredients in vaccine are similar to ingredients in Taltz. The outcome of event was unknown.  No follow-up attempts are needed. Information about lot/batch number could not be requested. No further information is expected.
An hour or so after the injection I began to notice my vision was slightly blurred. Saturday, it was blurry until late that evening when I noticed that the blurriness had subsided.
The first side effect experienced occurred 15 hours afer vaccine.  I had a very intense micraine like headache and pain in my sinuses.  24 hours after I experienced body aches, warm/hot flashes, extreme fatigue and headache.  My arm was extremely sore and hard with disconfort radiating up to shoulder and neck, right side.  Today, Day three after vaccine, the lump in my arm remain hard to the touch, larger in diameter, very red and raised and itchy and buring sensation.  This is not the first time I experienced these side effects, it occurred seven days after my first vaccine in the series.  With the first and the second vaccine I aslo experienced terrible migraine like headaches, body aches, chills, fatigue/lethargy and a much worst swollen left arm at the vaccine site. Second reported adverse reaction report.
This spontaneous report was received from a pharmacist and refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concomitant medications and concurrent conditions were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 lot # M043424, expiration date 16-JUN-2018 (route of administration and anatomical location were not reported). No adverse effects were reported. The administered doses of vaccines experienced the temperature excursion of 47 degrees Fahrenheit to 77 degrees Fahrenheit for 8 hours which was recorded by a digital data logger. No previous temperature excursion was reported. Additional information has been requested.
Case number PHEH2015US018120 is an initial spontaneous report received from a nurse on 15 Sep 2015. This report refers to a patient whose age was not reported. Past medical history and concomitant medications were not reported. The patient was vaccinated with FLUCELVAX (batch number: 006011A) intramuscularly on 14 Sep 2015. It was reported that the vaccine administered was expired and it was given to the patient in error by another member of the nursing staff. No adverse events were reported following the medication error.
After the vaccine, after I sat down, I started to feel shaky and felt light headed. My blood pressure was elevated and wasn't going away it lasted for a while. I went to UC to be seen.
There are two adverse events.  First is that the skilled nursing facility (SNF) clinical staff  incorrectly listed the patient as unvaccinated when requesting SNF patients be vaccinated by the local health department.  The patient was previously vaccinated with Moderna on 1/26 (Lot # 004M20A).   This should be listed as a vaccine administration error.  Second- Approximately, 1 week after being vaccinated with Janssen on 3/24/2021, the patient tested positive for COVID-19 (4/1/21).   At the time, the patient was documented to have an asymptomatic infection, picked up on weekly surveillance testing due to a large outbreak at the nursing facility.  I was informed on 6/9/21 that the patient had been referred to hospice on 5/4/21 and died on 5/6/21.  The medical records are not yet available (pending from the SNF and hospice agency) but the referral was made due to her COVID illness leading to worsening of her general health status.  During this period from 4/1 to 5/4, she remained at the SNF.  Notably, she was not hospitalized and did not present to the emergency department for care.
pt recv vax & pt was hosp w/RSV bronchiolitis & diarrhea;2 days later pt was discharged from hosp; however, mushy diarrhea (once/day) persisted;3/3/99 stool cult positive for Giardia & a stool positive for rotavirus antigen; pt recovered
04/08 - Staff Infection w/ abcesses, doxycycline, treatment successful 04/08 - Basal Cell Skin Cancer found via biopsy, mohs surgery, treatment successful 05/10 - Swollen lymph node in right armpit, mammogram and ultrasound, no cause found  09/03 - Pre-Cancerous cells on cervix found via colposcopy, treated with cold knife biopsy, no abnormal cells detected
Patient began experiencing headaches, dizziness, altered mental status, admitted to the hospital 2 days later with DKA
rash noted Tuesday 10AUG93, under arms, chin, diaper area; rash generalized by 11AUG93-rash raised, blotchy, mottled purplish; sl swelling in lymph glands in neck; acted cranky & ?fever;
Client received Hep-A injection and was in the middle of receiving a MCV4 when he passed out.  He had LOC for only a few seconds.  I was able to place him in a supine position on the exam table.  He then awoke and was pale, nauseated, and sweating.  The client was allowed to rest and given water.  He was then able to complete his vaccinations and left the building unassisted with his parents.
MD reported that a baby devel a generalized rash over its entire body following administration of details were provided;
This spontaneous report was received from a physician refers to a 20 year old female patient. On 12-DEC-2013, the patient was vaccinated with GARDASIL, 0.5 ml, intramuscular. On an unknown date in December 2013 (also reported as before 25-DEC-2013), the patient experienced rash that looked like bug bites on her face and other unspecified areas of her body. The patient sought medical attention and was seen by the physician on an unknown date. Other suspect drug included DEPO-PROVERA (also reported as DEPO shot), which was administered the same day as the GARDASIL was administered. The outcome of the event rash on her face and other unspecified areas of her body were unknown. The reporter did not provide the causality between the events and the suspect drug. Additional information has been requested.
He started coughing, complaining of lips and skin itching/tingling. Eyes were red and watching. Also site reaction to Right arm.
By the evening of Dec 21 I started having a fever and chills that lasted most of the night.  By the next morning I had severe shooting nerve pain in my neck and head and severe muscle spasms.  The nerve pain was also present in other parts of my body off and on. I also had muscle spasms in various extremities of my body at the same time. These symptoms lasted for about two weeks. By 12/24 and 12/25 I had swelling on the arm I received the injection in, redness and bruising, very tender to the touch on the part of  my arm from the upper arm to my elbow.  Since all this happened around Christmas and through New Years I could not get in touch with my local facility and was forced to call their tele-doc facilities and try to describe what was happening. These symptoms persisted and I had to call at least twice. On Christmas day the doctor said it sounded like I had a UTI and prescribed an antibiotic and also prescribed a topical ointment for my arm issues. A pharmacy wasn't open anywhere on Christmas day that I could get either prescription filled until at least December 26 or it could have been December 28. I didn't have any of these symptoms until I received the shingles vaccination. The antibiotic prescribed did not help with what symptoms I was having. The topical cream, triamcinolone acetonide cream, did help my arm to take away the pain and swelling.  I had all of this happening for at least two weeks and even now get periods of recurring nerve pain and the muscle spasms that come on.
10cmx10cm erythematous, fever within 2 days of administration of DTaP. Had doctor's appointment in office 7/30/03; given Augmentin. Went to ER worsening. Erythema given IV antibiotics. Seen 8/11/03 in doctor's office; symptoms resolved.
Red, swollen, and extremely tender muscle/skin at site for 4 days.  Low fever.  Prolonged crying and refused to use arm for the rest of the evening.  Tiredness and poor appetite.
Idiosyncratic reaction to my first Shingrix shot; Hives; Rash; Fever aches; Night sweats; Fever; Autoimmune hemolytic anemia; This case was reported by a consumer via media and described the occurrence of autoimmune hemolytic anemia in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced autoimmune hemolytic anemia (serious criteria GSK medically significant), idiosyncratic drug reaction, hives, rash, pain, night sweat and fever. On an unknown date, the outcome of the autoimmune hemolytic anemia, hives, rash, pain, night sweat and fever were recovered/resolved and the outcome of the idiosyncratic drug reaction was unknown.   The reporter considered the autoimmune hemolytic anemia, idiosyncratic drug reaction, hives, rash, pain, night sweat and fever to be related to Shingrix.  Additional details were reported as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The age group was not reported but was selected as an adult as per vaccine indication. The patient stated that he/she had an idiosyncratic reaction to his/her 1st Shingrix shot which he/she believe was reported to the FDA. The patient had experienced rash/hives, fever aches, night sweats and fever and developed autoimmune hemolytic anemia which persisted for 6 months. The follow-up would not possible as no contact details were available.
No adverse effects after 1st shot.  On Friday approximately 6 hours after 2nd shot at approximately 9pm CST, daughter started feeling depressed, body aches, lethargic.  Saturday morning still not feeling well.  Saturday afternoon she took about a 3 hour nap, felt 90% better.  By Saturday evening, she was 100%.
Sudden flares of previously quiescent apical abscess,  lymphedema & arthritis. The tooth infection required Rx antibiotics for 2 weeks. The lymphedema & arthritis required anti-inflammatories. The  entire inflammatory episode lasted 2-3 weeks total.
feeling ok not perfect; This is spontaneous report from a contactable nurse reporting for herself. This female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 21Dec2020 at single dose for COVID-19 immunization. Medical history and concomitant medications were unknown. The patient got the Pfizer Covid-19 vaccine on 21Dec2020 and wanted to know if she was contagious. She stated she knew it's not a live vaccine and it's an MRNA vaccine. Her pharmacist told that she was not contagious, but she just wanted to make sure. The patient was feeling ok not perfect. The patient did not state any side effects. Outcome of the event was unknown.   Information about lot/batch number has been requested.
Tired the next day  Swelling and tender on armpit of vaccinated arm; this is ongoing
Itchy everywhere but not a rash; I don't have any severe allergic reaction; A spontaneous repor was received from a consumer who is 66-year-old, female patient that received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a reaction like allergy stating she was itchy everywhere.   The patient's medical history included allergy to thimerosal. Concomitant medications included were vitamin D, calcium gluconate, amlodipine, vitamin B12, and vitamin E.   On 28-Dec-2020, the patient received their first of two planned doses of mRNA-1273 (Lot 025J20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On an unknown date, after administration, the patient stated that she was experiencing a reaction similar to when she took "ethanol diamine" medication. She stated she is sure she's not having a severe allergic reaction, she is just "itchy everywhere", but there is no rash. The patient was treated with betamethasone dipropionate cream, timolol maleate, coal tar and hydroxyzine.   Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the events, itchy everywhere, was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event of generalized pruitus a causal relationship cannot be excluded.
Information has been received from a physician and a medical assistant referring to a 20 year old female patient. No pertinent or historical conditions were reported. On 01-OCT-2015 the patient was in with her father and inadvertently vaccinated with ZOSTAVAX, 0.65 ml, subcutaneously in the left arm (Lot number L0216808 was an invalid lot number for ZOSTAVAX, expiration date 10-SEP-2016) instead of the flu vaccine by mistake. This was reported as staff error only. No adverse effects were reported at the time of reporting. Additional information has been requested.
2:42 p.m. dizzy and then became limp and started to become unconscious and slumped in chair and didn't respond verbally.  2:45 p.m. after cool cloth on head and legs elevated, began slowly responding.  2;49 p.m. fuly conscious and answered questions but weak.  Hadn't eaten since 7:30 a.m.  Gave orange juice and peanut butter crackers.  3:00 p.m. ambulatory and home with mother.
After the first vaccine administered on 3/24/2021 I had a grand mal  on 4/5/2021. I was hospitalized for three days to make sure nothing else transpired.  It was ruled post-vaccination breakthrough seizure.  The only other times I had a seizure is when I had autoimmune encephalitis on 4/2020 but they stopped after the encephalitis went away. I even had repeat MRI, Pet scan to make sure brain looked good and no atrophy of temporal lobes and inflammation left from this condition. Everything came out good on the follow-up scans that were done.  I then had the second vaccine and 23 hrs later had a grand mal seizure and was hospitalized for seven days. This was ruled post-vaccination breakthrough seizure. I haven't had anymore seizures since my vaccines.
Severe stomach cramping; Nausea; Bad headaches; Fatigue; Frequent urination; Muscle cramping; Muscles aches all over body; This is a spontaneous report from a non-contactable consumer, the patient. A 27-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on an unknown date in 2021 as a single dose for COVID-19 immunisation. The patient had no medical history and known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The concomitant medications were not reported. On an unknown date in 2021, the patient experienced severe stomach cramping, nausea, bad headaches, fatigue, frequent urination, muscle cramping and muscles aches all over body. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events severe stomach cramping, nausea, bad headaches, fatigue, frequent urination, muscle cramping, muscles aches all over body was not resolved at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
itching from ankle to head here and there/itchiness/itchiness on his ankle, leg, scalp, and back; soreness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching from ankle to head here and there/itchiness/itchiness on his ankle, leg, scalp, and back) and INJECTION SITE PAIN (soreness at the injection site) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Patient realized that he was on Meloxicam in 2019 and had allergic reaction.) in 2019. Concomitant products included ADALIMUMAB (HUMIRA) and MELOXICAM for an unknown indication.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced PRURITUS (itching from ankle to head here and there/itchiness/itchiness on his ankle, leg, scalp, and back) and INJECTION SITE PAIN (soreness at the injection site). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (ALLERGY [DIPHENHYDRAMINE HYDROCHLORIDE]) on 22-Jan-2021 for Itching all over, at an unspecified dose and frequency and CETIRIZINE HYDROCHLORIDE (BENADRYL ALLERGY [CETIRIZINE HYDROCHLORIDE]) on 22-Jan-2021 for Itching all over, at an unspecified dose and frequency. On 25-Jan-2021, PRURITUS (itching from ankle to head here and there/itchiness/itchiness on his ankle, leg, scalp, and back) had resolved with sequelae and INJECTION SITE PAIN (soreness at the injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Due to incomplete documentation at the skilled nursing facility, a patient received a second flu shot in the same flu season year.  No adverse events occurred but need to report the patient receiving 2 flu shots in 1 year.
Case number PHEH2015US013965 is an initial spontaneous report from a consumer received on 15 Jul 2015 and a follow up report from the consumer received on 20 Aug 2015. This report refers to an adult female patient. Medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number 1205401) intramuscularly in Jan 2013. Since the vaccination in Jan 2013, she felt like there was cement throughout her body. She was active and agile before but not since the shot. She also experienced myalgia, malaise and fatigue after vaccination. The outcome of the event was reported as "ongoing". The seriousness and causality of the event was not reported. Follow up report from the consumer received on 20 Aug 2015: Added patient's age group and events (malaise, myalgia and fatigue).
This spontaneous report was received from a nurse refers to a patient of unknown age. On 08-SEP-2015, the patient was vaccinated with an expired dose of PNEUMOVAX 23 lot # K009809, expiry date 16-MAY-2015, 0.5 ml, intramuscular. No adverse effects reported. Additional information has been requested.
I had an unexpected period shortly after my first injection. This could have been a miscarriage, as my husband and I may have conceived on 10/17/21, 10/18/21, or 10/19/21. (Please note, my husband and I have been practicing Marquette's Natural Family Planning since 2/21/2020. At the time of my vaccination, I had charted 22 complete cycles from 2/21/2020 through 10/8/2021. Before my vaccination, my 23rd cycle started with my period on 10/9/2021. I ovulated within 48 hours of 10/17/2021, as indicated by a rise in Estrogen and a rise in LH by my monitor. Per my history, I was expected to have about 13-16 more days before my next period from 10/17/2021. This came early by 8-11 days, which is has never happened before while charting.)
Patient was administered the second Menactra dose a week ago. Two days later the right side of his face began to feel numb. His mother noted that his mouth was sagging towards the left side at rest. Patient also lost his sense of taste on the right side of the mouth. He was subsequently diagnosed with Bell's Palsy and prescribed oral steroids and an unrecalled antibiotic. He has two more days left on the oral steroid.UNABLE TO RAISE THE RIGHT EYEBROW; MOUTH IS SYMMETRICAL AT REST BUT DEVIATES TOWARDS THE LEFT SIDE WHEN ASKED TO SMILE; RIGHT BUCCAL MUCOSA, RIGHT UPPER AND LOWER GINGIVA AND HARD PALATE IS NUMB, RIGHT SIDE OF THE LIPS IS NUMB. Advised to complete course of oral steroids.Call in 7 days if no improvement.
he felt very dizzy; his lips felt very swollen; My lips and mouth felt numb and swollen; My lips and mouth felt numb and swollen; headache; his blood sugar was down to 50; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that an 86-year-old male patient started to receive second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot# EN9581) via an unspecified route of administration on 04Feb2021 at single dose for COVID-19 immunisation. The patient's medical history includes diabetes. The patient's concomitant medications include carvedilol (COREG), rosuvastatin calcium (CRESTOR), repaglinide (PRANDIN), adenosine (TRICOR), metformin and amlodipine besilate (NORVASC). On an unknown date, the patient reported that blood sugar was 130 on that morning. He had his normal breakfast and went to get his shot within about an hour after getting a shot he was home and he was having my lunch. He was halfway through lunch he answered his doorbell and he got extremely dizzy. His lips and mouth felt numb and swollen. On 04Feb2021, his blood sugar was down to 50. There was no reason and no explanation for precipitated drop in blood sugar other than the fact that he had the Covid shot. Subsequently he spoke to cousin of his who is physician to heard of someone who had an adverse reaction like low blood sugar and was hospitalized. Nowhere in the side effects warning doesn't say anything about diabetic with low sugar and with low population over 65 it seems to me that would great number of people who have diabetes and low blood sugar problem. In case indeed of indication of adverse effect of covid. The patient advised that a warning should be on leaf. At least people have sugar tablets or some form of counteracting low blood sugar especially since these are 5-7 have driven to and he was just very thankful but he had to get the shot in (city). He was driving from (city) on 95 for 70 miles an hour. He would have got dizzy and headache and low blood sugar reaction while he was in transit. He was thankful that he got home in time for this not be a tragedy. It was reported that no other treatment was taken by the patient other than consuming large amount of orange peels. The outcome of the events was unknown.
Fever over 100 and extreme soreness in arm and lack of mobility in arm. Extreme weakness. Fever lasted 4 days, arm soreness is still present after a week. Antibiotic started after two days.
It was reported that a 48 year old female patient received a Fluzone SV '01-'02 vaccination administered on 10/11/01. Two hours a after the vaccination, she developed a reddened area at the injection site. The next day, she developed a reddened area on her neck  and now has an area on her face (the size of a dime). The patient was seen by her family physician and a dermatologist. The dermatologist prescribed the patient Triamcinolone acetonide 1% cream. The symptoms are unresolved.
"14 hours after receiving the vaccine developed flu-like symptoms (achiness, chills, felt like getting a fever but took Tylenol right away when aches kicked in). Ended up being in bed all day and continued to take Tylenol throughout the day as aches would come back when Tylenol wore off."
The vaccine's actual expiry date was 09/30/2022. The vaccine was administered to the patient on 10/02/2022. Upon, enquiring with the manufacturer (pfizer),the stability data supported the use of the product through 10/19/2022.  Since the vaccine was administered before 10/19/2022 re-vaccination of the dose was not required.