chrisvoncsefalvay/vaers-outcomes huggingface dataset:
It started with a numbness tingling in my left big toe and the pain moved to the rest of my toes in my left foot and then to my whole foot. The pain then moved to my right ankle and the right side of my body. My whole body was burning, it felt like an electrical shock. I went to the ER/Urgent Care where I had a CT of brain/lower back and bloodwork. My whole body just burns and the limbs of my body just feel heavy and dead. Its really miserable.
Arm sore at injection site. Pain progressively worsens and stays for rest of month. Methylprednisolone dose pack 4 mg started 10/26/2015 with no affect. Physical therapy started 11/04/2015 which continues 2/3 times per week.
Administered 0.5 mL of vaccine, not 0.3 mL; This is a spontaneous report from a contactable healthcare professional.   A 20-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162), intramuscularly in the left arm on 08Apr2021 (at the age of 20-years-old) as a  0.5 ml single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported.  On 08Apr2021, the patient was administered 0.5 ml of BNT162b2 vaccine, instead of 0.3 ml. The event did not result in doctor or other healthcare professional office/clinic visit or emergency room/department or urgent care. No therapeutic measures were taken as a result of the event. The clinical outcome of the event was unknown.   No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: reaction data (updated event to overdose), treatment (NO), and outcome (UNKNOWN).
I experienced hissing or ringing in my ears roughly 3 days after receiving the vaccine.
Myalgia, Arthralgia, Fever, Angina, LEFT NECK PAIN, RIGHT EYE PAIN, NUMBNESS ACROSS FACE AND BELOW NOSE Narrative:
Patient experienced pain and weakness in the arm, as well as, in the shoulder. The patient continued having this pain almost a week after vaccination.
Severe chills from 8:30 PM to 11:00 PM, vomiting from 9:30 PM to 10:00 PM, fever from 11:00 PM to 3 AM.
tested positive after receiving the first dose of the pfizer vaccine/ she took an antigen test and was positive; sinus infection; This is a spontaneous report from a patient.   A female patient of unspecified age received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: UNKNOWN) via an unspecified route of administration on 29Mar2021 as single dose for COVID-19 immunisation. The patient medical history included auto-immune disorder and Rheumatoid arthritis. Concomitant medications were not reported. On an unspecified date after the first dose, the patient tested positive for Covid-19. On the same day of getting the first dose Pfizer vaccine, they took covid tests and were both negative. They have been taking the precautions. A few weeks later, on an unspecified date, she had a sinus infection, and she took an antigen test and was positive. She has been doing her research and when she got the first dose of the covid, she developed antibodies so, she could test positive. She tested positive for Covid and had the symptoms for five days. Her doctor told her to take it after 10 days. She was scheduled for her second dose on 19Apr2021 and asked if she can get the second dose of the vaccine on 19Apr2021. Outcome of the events were unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
This spontaneous report as received from a health care worker refers to multiple unspecified patients of unknown demographics. The concurrent condition and medical history was not reported. On unknown dates, the patients were vaccinated with improperly stored ZOSTAVAX (Lot # L039126, Expiry: 08-JAN-2017; Lot # L044529, Expiry: 09-FEB-2016). The vaccine was stored at 16 F for a duration of 1 hour and 11 minutes. There were no previous excursions. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Patient had urticarial rash face, arms, upper torso and dizziness, immediately following administration of immunizations noted.
Symptoms: Chest Tightness/Pain, Shortness of Breath, Raspy Voice, Elevated Heart Beat, Elevated Blood Pressure, Stomach Pain, Muscle Cramps, Joint Stiffness, Headache, Dizzy, Anxiety, Tired, Overwhelming Feeling of being Unwell. Treatment: Admitted to Hospital Emergency Room 10/21/2021 @ 10:00 AM, Released 10/23/2021 @ 12:19 PM. Treatment: STOP Amlodipine-Atorvastatin 10-40, START Amlodipine Besylate 10mg, START Atorvastatin Calcium 80mg, START Pantoprazole Sodium 40mg X2.
Pfizer-Biotech COVID-19 Vaccine EUA, PT DENIES ANY SIGN OR SYMPTOMS OF SIDE EFFECTS OR ADVERSE EVENTS AT THIS TIME. PT WAS ADMINED DOSAGE THE WAS RECONSTITUTED WITH 0.8ML INSTEAD OF 1.8ML.. WAS NOT UNTIL 4TH DOSE FOR 4TH PT WAS DRAWN UP WAS IT REALIZED THERE WAS NOT ENOUGH TO COMPLETE 6 INJECTIONS FROM MULTI DOSE VIAL. FOR REMAINING RECIPIENTS. ADMIINISTRATION WAS STOPPED, MED RETURNED TO VIAL PLACED IN SEPERATE BAGGIE AND RETURNED TO PHARMACY. PHARMACIST, PFISER AND HOSPITAL ADMIN WERE NOTIFIED. aLL REMAINDER DOSES FROM FOLLOWING VACCINE VIALS AND ADMINS WERE RECONSTITUTED WITH 1.8ML OF PRESERVATIVE FREE SODIUM CHLORIDE AS ORDERED, THE VACCINE THAT WAS RECONSTITUTED WITH INCORRECT CONCENTRATION WAS PLACED IN PHARMACY FOR PHARMACY TO FOLLOW UP. # DOSES WERE GIVEN TO 3 SEPERATE PTS OF HIGHER CONCENTRATION DOSAGE. there WERE A TOTAL OF 5 0.3ML INJECTIONS IUN THE BOTTLE INSTEAD OF 6.
Information has been received from a healthcare worker referring to a patient of unknown age and gender. Patient's medical history and concurrent condition was not reported. On 13-FEB-2015 the patient was vaccinated with a dose of improperly stored PROQUAD (Merck) 0.5 ml, subcutaneously (lot # K008579, expiry date: 13-DEC-2015). No adverse effects reported. No product quality complaint (PQC) involved. This is one of several reports received from the same source. Additional information has been requested.
Patient began having fever, body aches, chills and a redness reaction below the injection site that is warm to the touch.
Low grade fever for 5 days. Extreme nausea for 24 hours. Diarrhea for 72 hours. 24 hours after the injection the lymph node under my left arm swelled up to about the size of a baseball, it was extremely hot and painful. It stayed that size for 4 days, and then finally started getting a little smaller each day. It's officially been 10 days and I would say that lymph node is about golf ball sized now. I did see my doctor and she said it can be a normal side effect and as long as it's going down not to worry. I also was having pain in my back and the doctor suspected a possible pe, my d-dimer test came back positive twice but my platelets remained in the normal range. The second d-dimer was only 513 and considered barely out of range so we assume whatever clot I had dissolved on its own.
Few minutes after receiving the vaccine I have noticed slight shortness of breath, then after 45 minutes, I developed a headache.  These symptoms worsen as the day progressed. The severe headache and increased shortness of breath lasted 14 days along with dangerously elevated blood pressure, fatigue, and nausea.
pt recv vax;testing on 25aug95 was neg;ELISA testing on 16nov95 was still neg;
Drug overdose. The vaccine vial was not diluted with the 1.3 ml of diluent so my kids both received an overconcentrated dose = 28 microgram instead of 10 microgram.
Mild cellulitis (L) leg v.s. localized reaction to vaccine given. Saw patient in weekend clinic 7/28/12. Treated with TYLENOL, Amoxicillin and cold compresses.
Severe chest pains that felt like a heart attack; went to the ER department three times in one week until they determined it was not my heart but did not know why I was having chest pains. Still have severe chest pains occasionally that just seem to start for no reason.
INJECTION SITE PAIN WITHIN ONE HOUR ON 5/23/2021.  2:30 5/24/2021 MUSCLE PAIN, CHILLS, JOINT PAIN, NAUSEA, FATIGUE, AND FEVER.  SIDE EFFECTS SUBSIDED EXCEPT INJECTION SITE PAIN 3:00PM 5/25/2021.
HEADACHE; SORENESS AT INJECTION SITE; This spontaneous report received from a patient concerned a 72 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non alcohol user, and non-smoker, and other pre-existing medical conditions included the patient did not had no known allergies and no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-MAR-2021, the subject experienced headache. On 12-MAR-2021, the subject experienced soreness at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on 2021, and the outcome of soreness at injection site was not reported. This report was non-serious.
Immediately after receiving vaccine patient fainted. Before administering vaccine, patient instructed us that she faints with every vaccine she receives
Chills, fever, diffuculty breathing, 4:30PM. Fever chills, 10/14/2010 all day. Dizziness, Hoarseness, weakness, sore throat. 10/15/2010
Patient said she is experienced cramping and aching at injection site along with pain when lifting up her arm.
sweating and having to change clothes 3-4 times a night, she was concerned. Subsequently, they put off getting his second dose; This is a spontaneous report from a contactable consumer. This consumer reported for a male patient (son) that a 17-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown), via an unspecified route of administration on 13May2021 as single for covid-19 immunisation. Medical history included history of allergy problems. The patient's concomitant medications were not reported. Reporter stated regarding her 17-year old son, who got his first shot of the Pfizer BioNTech Covid-19 vaccine on 13May2021. She reports that he had a history of allergy problems and when he was telling her his problems with sweating and having to change clothes 3-4 times a night, she was concerned. Subsequently, they put off getting his second dose. She was wondering, was it too late to get the second dose? Reporter stated that while she understands that this was all new, that it was frustrating that she gets different information from different places and that was the reason a lot of people don't get vaccinated. Reporter was asking about use in patients like herself and several people she knows that are immunocompromised and/or taking immunosuppressants. Reporter was asking for information regarding immunocompromised people who are vaccinated and walking around without masks thinking that they're protected. Reporter asks how effective/ what was the protection level after one dose. The outcome of event was unknown.  Information about lot/batch number has been requested.
pt recv vax 19OCT98 & states that arm became swollen about the size of a quarter @ inj site by next day it hurt somewhat;did not have any inc swelling or pain until 25OCT98;arm began itching & swelling more;induration close to site;
Myalgia, Fever, left arm sore, chills, weak, tired Narrative:
Sharp pain on right side of chest; Arm hurt severely; Arm was bruised; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Sharp pain on right side of chest), PAIN IN EXTREMITY (Arm hurt severely) and VACCINATION SITE BRUISING (Arm was bruised) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007m209) for COVID-19 vaccination.     The patient's past medical history included Bypass surgery (On left side.) in 1999, Heart attack (Heart attack with two stents on right side.) in 2009, Heart attack in 2017 and Bypass surgery (Heart attack and stent on left side next to bypass surgery.) in 2017. Concurrent medical conditions included Stent placement (Heart attack and two stents on right side) since 2009 and Stent placement (Heart attack and stent on left side next to bypass surgery.) since 2017.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced CHEST PAIN (Sharp pain on right side of chest), PAIN IN EXTREMITY (Arm hurt severely) and VACCINATION SITE BRUISING (Arm was bruised). At the time of the report, CHEST PAIN (Sharp pain on right side of chest), PAIN IN EXTREMITY (Arm hurt severely) and VACCINATION SITE BRUISING (Arm was bruised) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Treatment information  provided
My breathing is picked up is labored little bit this morning; I am still shortness of breath vision; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 58-year-old male patient received bnt162b2 (BNT162B2  PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: EN6205), via an unspecified route of administration on 04Mar2021 at 10:30 (at the age of 58-years-old) as dose 1, single for COVID-19 immunisation. The medical history of the patient included blood pressure, cholesterol and Emphysema COPD pretty chronic. The concomitant medications included losartan (LOSARTAN) and metoprolol (METOPROLOL) and Perforomist. No Investigation Assessment was reported. The patient stated she got the first vaccine shot (Pfizer Covid-19 Vaccine) previous day and she noticed that her breathing is picked up is labored little bit that morning and she was on the medicine on a Perforomist and she noticed that morning. Previous night when she took that treatment, she still had shortness of breath vision, even she had took the treatment something. She stated that had any kind of side effects reported like that from people those are chronic pulmonary. She stated she got the shot on previous day (04Mar2021) at 10:30 in the morning and then that overnight started noticing, she was having more after 12 that morning was when she noticed that shortness of breath at 03:05 AM. The outcome of the events was reported as unknown.  No follow-up attempts are possible. No further information is expected.
Patient is fully vaccinated and boosted.  Presents to ED with shortness of breath and corona virus concerns.Positive for headache. Patient reports a 1 week history of cough and shortness of breath.  On arrival, satting 98% on room air.  Not tachycardic.  Normal vitals otherwise. Troponin negative, EKG unremarkable.   Requires no supplemental therapies. Discharged home.
felt tired; He had aches; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (felt tired) and MYALGIA (He had aches) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Nov-2021, the patient experienced FATIGUE (felt tired) and MYALGIA (He had aches). At the time of the report, FATIGUE (felt tired) and MYALGIA (He had aches) outcome was unknown.            No concomitant and treatment medications were reported.
Approximately 3 hours post vax pt became fussy. Pt screamed and rolled around in the bed as if in pain. The next day the pt developed a low grade fever and continued to cry all day. The next two days the pt started shaking her head side to side as if she couldn't control it about 3-4 times a day. All symptoms resolved on the next day.
Pt reported hives after vaccines on 7/9/03. Pt reported hives after yellow fever vaccine on 7/10/03.
The client's mother alerted EMT that the client was "breathing funny." EMT responded to the client. The client denied any shortness of breath or any other s/s of anaphylaxis. RN responded. The following was obtained with RN intermittently translating between languages. The client's mother stated that the client's "breathing was not normal." The client's mother said she noticed the client was "sweating and taking deep breaths." The client reported pain over the left area of her abdomen, under her rib cage. Vitals obtained by EMT at 5:56PM were as follows: BP 114/89, HR 85, O2 99%. Capillary refill was < 2 seconds on the client's left middle finger. The client's mother reported the client has a history of facial swelling after taking ibuprofen. The client has a history of appendicitis. The client's mother denied any other chronic conditions or medications. RN observed a bruise over the right upper arm that appeared to be healing. RN inquired about the bruise, and the client's mother reported the bruise was a result of the client practicing Taekwando. The client's mother explained the specific Taekwando move that caused the bruise. The client reported the pain under her left ribs with inhalation and exhalation. The client rated the pain at a 6 on a 10 point scale and described the pain as "shooting." The client's mother stated the client tolerated the first COVID vaccine Pfizer well and denied any s/s of anaphylaxis. RN  offered to activate EMS at 5:59PM and the client's mother declined. RN recommended the client and her mother stay in the observation area until the symptoms resolve. RN provided education to the client regarding when to seek EMS. The client's mother voiced understanding of this education. The client's mother said she wanted to monitor the client at home since they had already waited 30 minutes in the observation area. The client's mother stated she wanted to leave against medical advice. The client ambulated unassisted with a steady gait out of the observation area at 6:02PM.
Patient returned to clinic on 08/29/2008 complaining of tenderness on the outside of the right upper arm.  The patient experienced an
redness at the vaccination site / redness at the vaccination site is getting larger not smaller; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th February 2020, the patient received Shingrix. In February 2020, less than a week after receiving Shingrix, the patient experienced injection site erythema. On an unknown date, the outcome of the injection site erythema was unknown.   It was unknown if the reporter considered the injection site erythema to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication.  The patient received Shingrix vaccine and experienced redness at the vaccination site which was getting larger. The patient wanted to know regarding need of physician visit.
Red rash around injection site (oval around area approximately 5 inches in diameter) Itching  Red area is swollen
I have an interesting benefit; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 68 year-old patient received bnt162b2 (BNT162B2), administered in arm, administration date 30Sep2021 (Lot number: EW0182) as dose 3 (booster), single, administered in arm, administration date 26Feb2021 (Lot number: EN6203) as dose 2, single and administered in arm, administration date 05Feb2021 (Lot number: EM9809) as dose 1, single for covid-19 immunization.   Relevant medical history included: "Menopause" (unspecified if ongoing). Concomitant medication(s) included: ESTRADIOL taken for menopause (ongoing); PROVERA taken for menopause (ongoing).  The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "I have an interesting benefit".  Additional information: The patient had been plagued by cold sores on mouth and in his/her nose for years during change of season, any stressful events, and especially during the winter months. The patient had purchase an arsenal of products to help through the upcoming cold months. In addition, patient had supplies of antiviral drugs, creams, and lip balms, Patient changed diet to never, never, never eat peanut butter, which although I love, I know can activate my cold sore issues. I have not eaten peanut butter for years.   No follow-up attempts are possible. No further information is expected.
Patient reported diarrhea, nausea, muscle ache, chills lasted for 2-3 days.
I recieved vaccine around 5:00pm and before i left the building {approx 5 min.} my tongue felt numb, an hour or so later my lips felt numb{all on right side}i still wasnt too concerned and tried not to think about it the next day.I awoke sat.morning and my entire right side of my face was paralysed.i thought i was having a stroke, i look like ive had a stroke but doctor says bells palsy i researched the web and found numerous reports of this reaction but have never been told that it could be caused from flu vaccine.I would rather have had the flu.It has now been a week and im not better.
I was very shaky and very fatigue and experienced flu like symptoms. M y arm was very swollen for two weeks and it got very itchy.
pain-red, blister @ or near inj site 2wk ago-possible relation to vax, but doubtful;
Redness, swelling, itchy. Treatment with Allegra 180mg qd.
No adverse effects reported; a patient received unspecified dose of PEDVAXHIB that was improperly stored/experienced excursion on 5/10/2018.; Information has been received from a nurse referring to a patient of unknown age and gender. Information of concomitant therapy, pertinent medical history and drug reactions/allergies was not reported.  On 10-MAY-2018, the haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (lot # N003536, expiration date wasreported as November 2019, but upon internal validation established as 02-NOV-2019) was improperly stored. The stored temperature was 8.72 degree Celsius. The time frame was 1 hours and 35 minutes. There was more than 1 previous temperature excursion. The temperature excursion was detected by a data logger.    On 23-JUL-2018, the patient was vaccinated with improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (lot # N003536, expiration date was reported as November 2019, but upon internal validation established as 02-NOV-2019, strength, dose, frequency and route were unknown) for prophylaxis (improper storage of product in use).  No adverse effects were reported.
Information has been received from a LVN concerning a 72 year old female pt who at the end of September or beginning of October 2004, was vaccinated with a dose of Pneumovax 23 (lot number 649694/0386P). The pt developed a 3 inch area below the injection site which was swollen, red, and "looked like cellulitis". Unspecified medical attention was sought. The pt was treated with unspecified antihistamines. Subsequently, the pt recovered. The nurse requested that a lot check be performed on lot 649694/0368P. It was reported that the pt's injection site swelling, erythema, and cellulitis were considered other  medical events (OMIC). The records of testing prior to release of this lot have been checked by QA and found to be satisfactory. the lot complies with the standards of the CBER and was released. The nurse also reported 4 additional patients who developed injection site swelling, erythema, and cellulitis post vaccination with Pneumovax 23 (WAES0410USA01334, WAES0410USA01623, WAES0410USA01624, WAES0410USA01625). Additional information has been requested.