chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial tenderness at injection site 1/13/21 then red and warm 1/14/21 Joint pain 1/14  and muscle aches  started 1/15 and continued  along with headaches for 3 days. Went for a COVID test and negative. Injection site left arm is indurated and warm 1 inch area and pruritic at times for past 3 days to present .
Visited Zoom urgent care with chest pains, heart complaints and fatigue. Bloodwork showed elevated heart enzymes, hospitalized to Hospital ER with heart attack suspicion, looks like heart inflammation? test results pending, currently hospitalized and monitored
Redness, swelling, warm to touch, itchy, knot where injection was given. Pt was told to take BENADRYL and use ice for swelling. Pt came in office to be rechecked on 9-17-12.
He had fever and muscle aches 1-2 days post vaccine but on day 3 post vaccine he got chest pain and was found to have elevated troponin c/w myocarditis.  cardiac MRI pending.
Afib.  three days after my booster my heart went into Afib.  This happened after the second shot as well  Otherwise I was feeling fine.  I have had about five afib occurences in the last 2 years, two of which I attribute the vaccine but of course I can't be sure.  I could think of no other "triggers" this time.
sore arm; Fatigue; This is a spontaneous report from a contactable consumer (patient) received from a Pfizer sponsored Program COVAX Support. A 52-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0162) via an unspecified route of administration, administered in Arm Left on 23Apr2021 13:00 (at the age of 52 years old) as dose 1, single for COVID-19 immunisation. Medical history included barrett's oesophagus from an unknown date and unknown if ongoing. Concomitant medication(s) included lansoprazole (PREVACID) taken for barrett's oesophagus from an unspecified start date and ongoing. Patient historical vaccine included FLU vaccine via unspecified route of administration on 2019 for immunisation (the Pfizer vaccine is the only thing he has had since he had the flu vaccine in 2019). The patient experienced sore arm, fatigue on Apr2021. Reported as, he had none of the side effects after the vaccinations other than maybe a sore arm; and more like fatigue. Adds he doesn't really want to emphasize the fatigue as he is a truck driver, he was tired all the time, and he just kind of felt a little extra tired. He completely recovered from these effects. Outcome of all the event was resolved on 2021.
Injection site was sore and slightly swollen the night of the injection    The next morning the injection site was red in rectangular shape about 4" x 2" and was swollen.  After breakfast and shower felt very nauseous and faint.  Vomited twice and was very weak and woozy.  Drank water and orange juice.  Laid down for a few hours.  Was able to eat some soup at lunch and started to feel better.  Was also able to have soup again at dinner.  Next morning (about 40 hours after injection  was feeling much better (no nausea) but injection area is still a bit swollen and the red/pink area around injection is lighter in color, longer (about 6 inches toward armpit), and is still quite sore to the touch.  I had no adverse reaction when I had my first Shingles injection about one year ago.
Pt states that rash started on her neck and has since traveled to scalp and bilateral arms. Pt states that it is very itchy and has tried taking benedryl and no relief. Pt states she has had mild improvement.
chills, fever (99 degrees), body aches, headache - lasting about 6 hours
she died; This is a spontaneous report from a contactable consumer (patient was reporter's girlfriend). A 49-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced she died (death, medically significant) on an unspecified date immediately, 49-year-old from Pfizer. The patient died on an unspecified date. It was not reported if an autopsy was performed.  The lot number for BNT162B2 was not provided and will be requested during follow up.; Reported Cause(s) of Death: she died
This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced influenza-like symptoms, fever, pain, tiredness, injection site pain and injection site erythema. On an unknown date, the outcome of the influenza-like symptoms, fever, pain, tiredness, injection site pain and injection site erythema were recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms, fever, pain, tiredness, injection site pain and injection site erythema to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient experienced bad flu type reaction, Fever (101), aches, general tiredness as well as pain and redness at injection site after receiveing first shot of SHINGRIX. It lasted for a week. Lab Comments: On an unknown date, the patient's body temperature test was performed.
Information has been received on a patient who in the fall of 1997 was vaccinated with one dose of varicella virus vaccine live. In approximately October 2000, recent titers indicated that the patient had not seroconverted. The patient sought unspecified medical attention. Additional information has been requested.
APPROXIMATELY 5 MINS POST VACCINATION (HPV, MEN, TDAP) CLIENT APPEARED TO HAVE A SYNCOPAL EPISODE, AS PER WITNESS CLIENT HIT THE BACK OF HEAD, NO S/S LOC, CLIENT ALERT AND VERBAL, REPORTED FEELING DIZZY, DENIED ANY C/O PAIN/DISCOMFORT, PLACED IN TRENDENLENBUR POSITION, COOL COMPRESS APPLIED, SKIN W/D, BP 108/62, CLIENT EVALUATED BY MEDICAL PROVIDER, NO NEW ORDERS NOTED.
This is a spontaneous report received from a contactable physician. A male patient received unknown dose number of  BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), single dose, for COVID-19 immunization. Medical history and concomitant medications not reported. The patient experienced arthralgia/joint pain, with outcome of unknown. The information on the batch/lot number for BNT162B2 requested and will be submitted if/when received. Sender's comments: Linked report: US-PFIZER INC-202200967150 (same reporter/drug/AE, different patient).
I felt very drunk like I had vertigo. I was unable to think straight or keep my balance, I woke up in excruciating pain. My muscles had clenched and I was not able to move them. I had chills and all my joints ached. My husband gave me some Advil which stopped the chills and allowed me to sleep thru the night. The next day the muscle aches and joint pain were really bad and my head was throbbing. On the 26th I contacted my doctor who prescribed a 4 day dose of prednisone. By the end of the next day, it had all cleared up. It lasted a total of 48 hours.
Td vaccine, 0.5ml was inadvertently administered to the patient in place of the intended PPD.  Reaction included local erythema, warmth, induration (~25mm diameter), achy pain in affected (Rt.) upper extremity.  The patient was erroneously diagnosed with a (+)test result the next day and referred to the Health Dept. to be evaluated for TB prophylaxis.  Luckily, another provider noticed the error in the medical record and treated the patient with Allegra, Decadron and Avelox to cover the possibilities of local hypersensitivity and infection.
HIVES 11/9 and 11/10/2009 received vaccine records and MD records from 11/2/2009. This was a telephonic message stating patient's mother called to state that child had developed hives post vaccination. Tx: Dr rx'd Zyrtec.
Received vax on Monday evening. Didn't notice reaction of red left thigh. Seems like getting larger to mom. Child walking OK, afebrile (98). 03/30 same. Had played outside. Slept with mom. "Seems warm." Same next day.
2nd dose given from beyond use date vial; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (2nd dose given from beyond use date vial) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (2nd dose given from beyond use date vial). At the time of the report, EXPIRED PRODUCT ADMINISTERED (2nd dose given from beyond use date vial) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Left thigh, from knee to hip, red and swollen one hour or less after injection. No difficulty walking spreading to other parts of the body, no other reaction. Symptoms resolved by 9/12/17.
I had a lot of energy after my 2 shots, I was cleaning my house like crazy; No adverse event; This spontaneous case was reported by a patient and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (I had a lot of energy after my 2 shots, I was cleaning my house like crazy) and NO ADVERSE EVENT (No adverse event) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939902) for COVID-19 vaccination. Patient had no allergies. Patient never had COVID positive test or diagnosis. Patient did not receive other vaccines given within 1 month Prior to Moderna COVID-19 vaccine.  On 17-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On an unknown date, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (I had a lot of energy after my 2 shots, I was cleaning my house like crazy) and NO ADVERSE EVENT (No adverse event). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (I had a lot of energy after my 2 shots, I was cleaning my house like crazy) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   Patient was not on any concomitant medications for any condition.  It was reported that, the patient had a lot of energy for 2-3 days after the dose and got a lot of house cleaning done at that time.  Patient believes more in herbal remedies than medications. No treatment medications were provided.   This case was linked to MOD-2022-647612 (Patient Link).
The patient initially reported feeling what he described as a "burning" feeling moving through his body.  About 30 minutes later, he stated that he was fine and he felt that he likely had a fever.
Post vax, the pt had redness of her arm (from axilla to elbow), dizziness and nausea with no response to Benadryl.
Administered past the 30 day refrigeration time; Administered past the 30 day refrigeration time; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered past the 30 day refrigeration time) and PRODUCT STORAGE ERROR (Administered past the 30 day refrigeration time) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered past the 30 day refrigeration time). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered past the 30 day refrigeration time). On 02-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Administered past the 30 day refrigeration time) had resolved. At the time of the report, PRODUCT STORAGE ERROR (Administered past the 30 day refrigeration time) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product information was not provided.  Treatment information was not provided.  First shot info was given that -Expiration date: 31-Oct-2021,Date refrigerated: 20-Apr-2021, Temperature changes (in F): 41.
AFTER SECOND DOSE, CHEST PAIN, EFFORT INTOLERANCE, DIZZINESS, PARESTHESIAS, SUSPECTED COVID-19 VACCINE INDUCED MYO-PERICARDITIS
History given by mother vaccine given 11-16-09 9:30PM. 11-17-09 1A pt restless irritable in sleep, pt awakens. 3A - temp 101 (R) MOTRIN tsp given PO. Child restless, irritable, loss of appetite during the day. 5P pt restless irritable, loss of appetite - 1 tsp given PO. 8PM - pt went to bed & awoke 3A - 101 (R) - 1 tsp MOTRIN given PO. 11-18-09 9AM pt restless, irritable, decreased appetite, temp 100 (R). 7PM MOTRIN - 102: pt awoke 9:30PM. 11-19-09 - AM pt awoke warm to touch - MOTRIN given, pt restless. 11-20-09 - no concerns expressed by mom.
Swollen red eyes, runny eyes, runny nose, swollen gland in throat, heaviness in chest, trouble breathing. Aches and body pains.
I passed out and when taken to emergency room, they discovered low sodium level, which I had never happened. After couple days it worsened and became very low.
Patient was administered MMRV in error. MMR, Varicella and PCV-13 ordered by physician. LPN administered PCV-13, Varicella and MMRV.
Bulge/swelling in the Left armpit area that is non-pitting and reducible.  Tenderness upon palpation. Heat pack used for 20 min and Aleve 1 tablet given.
Fever and malaise since H1N1 booster vaccination one week ago. Very sleepy, irritated easily, anorexic, pain at injection site.
Child became very pale and said she didn't feel well. Cold cloths applied on back of neck and forehead. C/o throat feeling hurt. Pt asked for H2O and took pills. BP 118/105. pt color returned and pt walked out of clinic. Pt did not lose consciousness.
Patient reported heart palpitations that started the day after receiving the vaccination. She says they lasted for approximately 6 hours. She felt fine afterwards and reported no future issues. The patient reported this adverse event approximately 1 week after it happened.
I started developing fatigue in addiction to body aches and head tension, it's been going on for several weeks. I went to the doctor, I thought maybe it's stress from family issues. The doctor said I might have inflamation, after few weeks and called the doctor again and told her what's going on. she did some blood test and she noticed a pattern of the tests, she said I might have fibromyalgia. My stress level was very high, and I ve been taking care of myself.
My menstrual cycle began on April 11 as projected. My cycle lasted for 13 days and was only able to be stopped by taking birth control pills. I am using Paraguard non- hormonal IUD and have NEVER had a period lasting more than 7 days.  Symptoms were full bleeding enough to wear a tampon, back aches and cramps.  My OBGYN verified I had a negative pregnancy test.
I gave the patient a flu shot instead of a vaxelis shot and the patient is only 2 moths
Patient received Covid-Moderna vaccine on 2/3/21. Patient called 2/5/21 to report shortness of breath, unable to take deep breaths, headache, and arm hard/swollen. Requested patient to report to emergency department. Patient reported ED did Covid testing, blood work, scan for blood clots in the lungs. Stated nothing was found and no medication prescribed. They recommended to follow-up with primary care provider. 2/8/21 - called patient and reported is "feeling better", little shortness of breath, arm has returned to normal. Patient said followed up with cardiologist visit and was told to receive second covid vaccine.
A nurse reported that a 23 year old patient received an injection of Tetanus Diphtheria Toxoids Adsorbed, Purogenated on 06/18/00 and subsequently developed an injection site reaction characterized by redness, warmth, and swelling. The reaction persisted for at least 1 week. This is 1 of 3 patients from this facility who developed an injection site reaction following receipt of 2 different lots of Tetanus Diphtheria Toxoids Adsorbed, Purogenated.
pt recv vax 8AUG96 & on 9JUN97 pt devel a mild case of chickenpox, t102, runny nose, & cough;
Pt developed erythema & swelling to (L) thigh; area is warm to the touch had some mild cellulitis.
15AUG96 pt had 2 tonic clonic sz lasting 15min, t101.7 R;
back of his tongue was swelling; he can''t breathe; severe fever; severe cold; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose:01), for COVID-19 immunization; Bnt162b2 (Dose:02), for COVID-19 immunization. The following information was reported: SWOLLEN TONGUE (non-serious) with onset Oct2021, outcome "unknown", described as "back of his tongue was swelling"; DYSPNOEA (non-serious) with onset Oct2021, outcome "unknown", described as "he can''t breathe"; PYREXIA (non-serious) with onset Oct2021, outcome "unknown", described as "severe fever"; NASOPHARYNGITIS (non-serious) with onset Oct2021, outcome "unknown", described as "severe cold".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
big wild bright red rash on both cheeks with pimples; big wild bright red rash on both cheeks with pimples; This is a spontaneous report from a contactable consumer (patient).  A 69-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 10Mar2021 as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on unspecified date, single 1, dose for COVID-19 immunization. On unspecified date the patient experienced big wild bright red rash on both cheeks with pimples. reporter stated that it was starting to become a little less red than a few minutes ago and seems to be resolving but she did not read in any of our literature regarding a rash being a side effect but she read that Moderna had this type of side effect. The outcome of the events was unknown.  No follow-up attempts are possible. Information about Lot/Batch number cannot be obtained.
contracted COVID twice; Lack of efficacy; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (contracted COVID twice) and DRUG INEFFECTIVE (Lack of efficacy) in a female patient of an unknown age who received mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (contracted COVID twice) and DRUG INEFFECTIVE (Lack of efficacy). At the time of the report, COVID-19 (contracted COVID twice) and DRUG INEFFECTIVE (Lack of efficacy) outcome was unknown.      Concomitant medications were not reported.   Treatment medications were not reported.  Company comment: This is a spontaneous case concerning a full vaccinated female patient of an unknown age, with no medical history reported, who experienced the non-serious and unexpected AESI of COVID-19. The event and the 3 doses of mRNA-1273 vaccine were reported with no dates; hence, latency cannot be properly assessed. No further information on clinical presentation, course, treatment received, or other clinically relevant information, was disclosed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a full vaccinated female patient of an unknown age, with no medical history reported, who experienced the non-serious and unexpected AESI of COVID-19. The event and the 3 doses of mRNA-1273 vaccine were reported with no dates; hence, latency cannot be properly assessed. No further information on clinical presentation, course, treatment received, or other clinically relevant information, was disclosed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Fever 100.3 Body aches Head aches Nausea  Treatment: Naproxen and Tylenol
***First Issue*** Eight months after receiving my booster, I came down with CSU-Chronic Spontaneous Urticaria. After primaries treatment of antihistamine didn?t work primary referred me to Dr. Went through blood workup, medical history and any possible contributing factors. After weeks of being on mega high doses of antihistamine with no relief, Dr started me on Xoliar.  After 4 months of injections hives finally subsided.    ***Second Issue*** After first Pfizer injection, didn?t have menstrual cycle for 3 months After second Pfizer injection, didn?t have menstrual cycle for 4 months After Pfizer booster injection, didn?t have menstrual cycle for 8 months
Spot under her tongue was inflamed,Lesion under tongue had not healed; This spontaneous case was reported by a consumer and describes the occurrence of TONGUE DISORDER (Spot under her tongue was inflamed,Lesion under tongue had not healed) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026B21A and 002C27A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Apr-2021, the patient experienced TONGUE DISORDER (Spot under her tongue was inflamed,Lesion under tongue had not healed). At the time of the report, TONGUE DISORDER (Spot under her tongue was inflamed,Lesion under tongue had not healed) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Treatment information was not provided by the reporter.   This case was linked to MOD-2021-215096 (Patient Link).