chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a contactable consumer (Patient himself). A 39-year-old male consumer received bnt162b2 (BNT162B2, COVID-19 VACCINE; formulation: Solution for injection, Lot number: unknown, Expiration date: unknown) via an unspecified route of administration on Friday, 21May 2021 (at the age of 39-years-old) as Unknown dose, single dose for covid-19 immunisation. The patient medical history and concomitant medications was not reported. On the day of vaccination, he felt a slight numbness of the face, on the right side, above the eyebrow and the outside corner of eye and ending up in the jaw, he was let it go at that time when he leaving the vaccination center, But these days he felt that tingling or numbness again. Also felt tingling in hand. Patient was asked whether any reports on this. Events were considered as non serious. The outcome of the both events was reported as not recovered. Information about lot/batch number has been requested.
my mother developed a rash on chest, back, face with facial swelling, lip swelling and tongue swelling 10 days after second vaccination.   Placed on steroids and prescription antihistamines.  not sure if related to vaccine but no other change or administration of anything else.
Rebound after completing paxlovid. Tested positive with sx 27Apr, started 5 day rx with paxlovid, improved and began testing negative. Symptoms returned and started testing positive again 9May. Sympto; Rebound after completing paxlovid. Tested positive with sx 27Apr, started 5 day rx with paxlovid, improved and began testing negative. Symptoms returned and started testing positive again 9May. Sympto; This is a spontaneous report received from a contactable reporter(s) (Physician) from product quality group. The reporter is the patient.  A 38-year-old female patient received BNT162b2 (BNT162B2), on 21Jan2021 as dose 1, single (Lot number: EK4176), on 12Feb2021 as dose 2, single (Lot number: EL9264) and on 24Oct2021 as dose 3 (booster), single (Lot number: FF2593) at the age of 38 years for covid-19 immunisation. The patient's relevant medical history included: "Pregnancy" (unspecified if ongoing). Concomitant medication(s)/other medication in 2 weeks product included: ASPIRIN [ACETYLSALICYLIC ACID]; LEVOTHYROXINE. Other medication details: other medication in 2 weeks product: Prenatal vitamins. Past drug history included: Cefotetan, reaction(s): "known allergies Cefotetan", notes: known allergies Cefotetan. The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant), outcome "recovering" and all described as "Rebound after completing paxlovid. Tested positive with sx 27Apr, started 5 day rx with paxlovid, improved and began testing negative. Symptoms returned and started testing positive again 9May. Sympto". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (14May2022) POSITIVE, notes: Still sx and antigen positive 14May; (unspecified date) NEGATIVE, notes: began testing negative; (27Apr2022) POSITIVE, notes: Tested positive with sx 27Apr, started 5 day rx with Paxlovid; (09May2022) POSITIVE, notes: Symptoms returned and started testing positive again 9May; (14May2022) POSITIVE, notes: Still sx and antigen positive 14May. Therapeutic measures were taken as a result of covid-19, vaccination failure. Antiviral details: Product: COVID 19 Treatment, Brand: Paxlovid, Treatment start date: 27Apr2022, Treatment stop date: 02May2022, Indication: Treatment of COVID-19. Adverse event: Rebound after completing Paxlovid. Tested positive with sx 27Apr, started 5 day rx with Paxlovid, improved and began testing negative. Symptoms returned and started testing positive again 9May. Symptoms worse than the first time. Still sx and antigen positive 14May.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events and suspect drug BNT162B2 cannot be excluded.
Injection site pain; Tiredness; Mild headache; Chills; Muscle pain; Severe joint pain; Injection site swelling; Feeling unwell; Swollen lymph nodes, specifically left underarm area; Shortness of breath; Fast heartbeat; This is a spontaneous report from a contactable consumer (patient). A 34-year-old female patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL3247), via an unspecified route of administration in left arm on 19Jan2021 16:45 at single dose for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered was hospital. The patient medical history was not reported. No allergies to medications, food, or other products. There were no concomitant medications. The patient did not receive any other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced injection site pain, tiredness, mild headache, muscle pain, chills, severe joint pain, injection site swelling, feeling unwell, swollen lymph nodes, specifically left underarm area, shortness of breath and fast heartbeat on 20Jan2021 14:30. Not received treatment for the adverse events. Patient was not pregnant. Since the vaccination, the patient has not been tested for COVID-19. The outcome of events was recovered in Jan2021.
pt devel chickenpox;10/21/99 itching pox- like lesions, trunk, arms, neck;
fever; Head aches; anxiety; arm sore; nausea; This is a spontaneous report from a non-contactable consumer (patient) or other non hcp. A 25-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: En6198) via an unspecified route of administration, administered in Arm Left on 26Feb2021 17:30 (at the age of 25-years-old) as dose 1, single for COVID-19 immunization. Medical history included colitis from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. No other vaccines within 4 weeks prior to the COVID vaccine. No COVID prior to the vaccination. No COVID tested post vaccination. Not diagnosed with COVID-19 since the vaccination. On 26Feb2021, the patient experienced fever, headache, anxiety, arm sore and nausea. No treatment was given for adverse events. The outcome of the events was recovered on an unspecified date in 2021.  No follow-up attempts were possible. No further information was expected.
Swollen throat in the front under her chin; Her chest was tight and achy; Her chest was tight and achy; She experienced extremely swelling of lymph nodes on right neck and it radiated into the arm; Brain fog; Extremely fatigued; Feverish; Headache; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Brain fog), PHARYNGEAL SWELLING (Swollen throat in the front under her chin), CHEST DISCOMFORT (Her chest was tight and achy), CHEST PAIN (Her chest was tight and achy) and PAIN IN EXTREMITY (Sore arm) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A. and 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Lupus erythematosus. Concomitant products included METHOTREXATE, GABAPENTIN and ACYCLOVIR [ACICLOVIR] for an unknown indication.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), FATIGUE (Extremely fatigued), PYREXIA (Feverish) and HEADACHE (Headache). On 12-Mar-2021, the patient experienced FEELING ABNORMAL (Brain fog) and LYMPHADENOPATHY (She experienced extremely swelling of lymph nodes on right neck and it radiated into the arm). On 19-Mar-2021, the patient experienced PHARYNGEAL SWELLING (Swollen throat in the front under her chin), CHEST DISCOMFORT (Her chest was tight and achy) and CHEST PAIN (Her chest was tight and achy). At the time of the report, FEELING ABNORMAL (Brain fog), PHARYNGEAL SWELLING (Swollen throat in the front under her chin), CHEST DISCOMFORT (Her chest was tight and achy), CHEST PAIN (Her chest was tight and achy), PAIN IN EXTREMITY (Sore arm), LYMPHADENOPATHY (She experienced extremely swelling of lymph nodes on right neck and it radiated into the arm), FATIGUE (Extremely fatigued), PYREXIA (Feverish) and HEADACHE (Headache) had not resolved.            Treatment information included Advil and Acyclovir
PNEUMOVAX 0.5ml IM administered in right arm deltoid on 12/6/10 at 1400. Pt. reported on 12/7/10 that her right arm just above elbow region & (below inject site) was red, warm, swollen, & painful. Onset sometime during the evening of 12/6/10. TYLENOL & cold compress to area prn.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2013, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On an unknown date in 2016, the patient was treated by a physician for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Pt became lightheaded, dizzy and fell from chair in post vaccine observation area. No injury from fall, BP 75/38, Pt states has happened before with blood work and while getting a body piercing. Transported to ED, given hydration and food,  Discharged to home. She did receive 2nd vaccination on 05/18/2021 without incident
erythema multiforme type rash 3-4 days p/vax; tx Atarax;
Information has been received from a health professional concerning a 9 year old male patient who on 01/04/1999 was vaccinated with a dose of varicella virus vaccine live.  Subsequently, on approximately 04/30/2004, the patient developed breakthrough chickenpox with less than 50 lesions.  Follow up information indicated that there was not a single report of adverse reaction following varicella vaccination.  The reporter indicated that 49 other patients developed breakthrough cases of chickenpox.  No additional information is expected.
The patient presents with URI symptoms for approximately 3 weeks for all sinus symptoms- saw urgent care and started with augmentin for sinusitis and no improvements so was switched to Cefuroxime 500mg BID x 14 days- she is overall feeling a lot better in general though the last day or 2 noticed she couldn't smell and couldn't taste.
chills - mild, fever-mild, body aches-moderate, fatigue-major Lasted about 20 hours, patient slept nearly entire time
pt recvd vax & was dx w/ viral influenza; symptoms included achiness esp in neck, arms, & shoulders; f of 100.6 & cough; tx w/ zithromax, ampicillin, & robitussin DM;
Immediately following vaccine for 2 days after I experienced severe muscle pain- full body and headache. The side effects subsided after 2 days but has returned now 2 weeks after vaccination and are gradually increasing in severity.
Screaming episode lasting approx 3 hrs following DTP/OPV immunization.
My son had a seizure (something he have never had before) two weeks after getting these vaccines. He's never been prone to seizures, doesn't run in our family history.
I was diagnosed with high blood pressure this year.  My blood pressure's all throughout the year 2020 were within normal limits.  Looking back a couple of months ago, my blood pressure was checked in January, and that is when they were high in the 130's and 140's.  I saw a primary care APN who placed me on blood pressure medication.
Left upper arm redness, slight swelling, painful to touch, afebrile, seen in ER, no RX. 11/17/2005 client able to golf 2 days after shots.
duplicate flu shot vaccine- patient requested the vaccine twice one week apart-  no adverse event was reported by the patient-well tolerated both.
On Wednesday 1/27 the day after my second dose I felt a minor pinch/discomfort  on my lower leg.  I did not think much of that is reason I did not report it right away.  Day by day the discomfort and pain got worse.  Exactly one week after my second dose I was not able to sleep due to the pain.  On Wednesday 2/3 I decided to go urgent care.  From there I was referred for an ultra sound a few hours after.  After the ultra sound I was contacted by my doctor, letting me know that the results showed I had a blood clot on my left leg.  I was put on Eliquis medicine right away.  On 2/5 I was able to physically see my doctor who told me that this was caused by the second dose of the moderne vaccine that I took on 1/26.
Patient received a dose of 12+ Pfizer instead of the 5-11 year old dose.  Patient was observed for 15 minutes after dose was administered with no adverse reactions observed by nursing staff  or verbalized by patient or guardian. Spoke with mother on 2/10/22 and she stated child was doing fine and no adverse reactions noted. Mother was also informed that a second dose is not recommended per the CDC  COVID-19 Vaccine Administration Errors Revaccination Guidance.
5/15/13 pt presented w/erythema (9cmx5cm), swelling, pain, fever, chills, fatigue, and stiffness.
Started feeling forgetful and having bad headaches and migraines that my medication did not help. Had a seizure almost exactly 1 month after the 2nd dose.
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On unknown dates the patients were vaccinated with improperly stored VARIVAX (lot # L050956, expiration date 17-DEC-2017; lot # L045954, expiration date 17-NOV-2017; lot # M000760, expiration date 06-JAN-2018, route and dose were not reported). The vaccines were exposed to 6 F for 5 minutes without previous excursion. The issue was due to data logger. No symptoms were reported. This is one of the several reports from the same reporter. Additional information has been requested.
cold; runny nose; This is a spontaneous report from a contactable consumer (patient). This female patient of unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration on 06Mar2021 as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient reported she received her first dose of BNT162B2 on 06Mar2021 and was scheduled to receive the second dose on 26Mar2021. She reported she worked with kids and developed a little bit of a cold and runny nose and had been taking dextromethorphan hydrobromide, doxylamine succinate, ephedrine sulfate, ethanol, paracetamol (NYQUIL) and dextromethorphan hydrobromide, guaifenesin, paracetamol, pseudoephedrine hydrochloride (DAYQUIL). She inquired if she could take the second dose of the vaccine on 26Mar2021 or if she should reschedule. The clinical outcomes of cold and runny nose were unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Patient developed angioedema of her eyelids after COVID-19 vaccination.  She received her Covid vaccine on 1/10/2021 at 11:30 AM.  She received the Pfizer vaccine.  She works at a nursing home.  She had some fatigue and tiredness during the day but woke up on the second day without any symptoms.  On 1/30/2021, she developed bilateral eyelid swelling.  The swelling is mild to moderate intensity involving the upper and lower eyelids bilaterally with a prickly burning sensation associated with pruritus.  The reaction lasted less than a day and resolved without any skin desquamation, scarring or bruising.  She denies any hives anywhere else.  She does not have a large local reaction at the injection site.  She denies respiratory complaints, GI symptoms, lightheadedness, loss of consciousness, wheezing, swelling of her throat or other symptoms consistent with anaphylaxis.  She used Benadryl with significant improvement.   She had a significant reaction after influenza vaccination consisting of swelling of her face and her eyelids with development of dry patches bilaterally within 2 days, resolving with skin desquamation.  The reaction lasted for 1 week.  She received her influenza vaccination in October 20, 2020.   She was seen in our office in 2012 for bilateral eyelid angioedema with associated urticaria shortly after swimming in the pool.  She was given oral antihistamines ?Zyrtec once daily? with significant improvement as well as prevention of this reaction.  She has not had this reaction  for more than 6 years.
This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 13-OCT-2015, the patient was vaccinated with improperly stored RECOMBIVAX HB (exposed to the following temperatures and cumulative time frames colder than 36F: In September of 2015, the coldest temperature was 34F for 346.7 hours (over 14 days); In October of 2015, the coldest temperature was 34F for 492.6 hours for a total of 839.3 hours (35 days); In November of 2015, the coldest temperature was 34F for 192 hours, for a total of 1,031.3 hours (43 days)) with lot number: L010595, expiry date: 12-NOV-2016 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Information was received on 16-JAN-2018 from a lawyer regarding a case in litigation concerning a patient (gender and age not reported). The patient was inoculated with ZOSTAVAX on or about 10-SEP-2014, administered by a physician (at an unspecified facility/office), as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended but rather caused the patient to contract a persistent strain of herpes zoster.  On or about 07-DEC-2015, the patient was treated by a physician (the same physician who administered the vaccine, at an unspecified facility/office) for the onset of a severe vesicular rash accompanied by weakened immune symptoms which was diagnosed as severe herpes zoster, or shingles. As a direct and proximate result of these malfunctions the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain, suffering and other damages. The outcome of the severe herpes zoster, weakened immune symptoms, and vaccine did not prevent shingles was unknown. Additional information has been requested.
Systemic: right arm tingling-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: Pt reported vaccine injection hurt more than expected and immediately she reported tingling in her arm
Local reactions-swollen, hot to touch, red at all four vaccination sites given, four days ago. Baby is very fussy, cries when upper legs touched. Local reactions seem more intense then what is normally seen-have lasted longer.
Fever with temperature of 102.2 degrees F; Chills; Headache; Nausea; Body ache; This is a spontaneous report from a contactable consumer reporting for herself.  A 51-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 27Jan2021 15:50 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced fever with temperature of 102.2 degrees F, chills, headache, nausea and body ache in Jan2021. Outcome of the events was unknown. Information about lot/batch number has been requested.
Chest Pain, Abnormal Heartbeat, Shortness of Breath, and Heart Palpitations.
Pt developed nipple tenderness after vaccine. Parents note breast buds that were not present prior to the vaccine. Brought in to be seen by PCP. On exam breast are enlarged at stage II. It is unclear if this is caused by vaccine. Mother wants to know if she should proceed with second vaccine.
Exactly one week after her dosages she developed vertigo for the whole day. Every time she sat down she would get dizzy. The first time I did not associate it to the vaccine, but after the second one, and it happened again, I associated.  Called the pediatrician.
This spontaneous report as received from a pharmacist refers to a 71 year old patient. On 14-AUG-2017, the patient was vaccinated with ZOSTAVAX lot # M032141 for prophylaxis. Concomitant therapies included sterile diluent. On 14-AUG-2017, 1 day after onset of therapy the patient experienced incorrect product storage. On an unknown date, the patient experienced no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to ZOSTAVAX. Additional information is not expected. Sender's Comments: US-009507513-1707USA007162: US-009507513-1708USA012398: US-009507513-1708USA012396: US-009507513-1708USA012399: US-009507513-1708USA012394: US-009507513-1708USA012395.
DTP given on 23AUG95 parent states started swelling 30AUG95; in swelling hot to touch, red, swollen >fifty cents piece
10/14/18 GOT THE FLU SHOT 10/24/18 - WAS SEEN AT DOCTOR FOR RASH THAT STARTED 10/21/18. DIAGNOSIS WAS PITORYASIS ROSEA. 11/1 RASH BECAME ITCHY AND SPREAD THROUGHOUT WHOLE BODY. WENT TO URGENT CARE. WAS TOLD POSSIBLE FUNGAL RASH. GIVEN CREAM AND SHAMPOO. DID NOT HELP 11/2 - FOLLOW UP W DERMATOLOGIST. PITORYOSIS ROSEA RE-CONFIRMS. GIVEN TOPICAL STEROID CREAM. TOLD TO TAKE THIS WITH BENADRYL TO HELP ITCH. 11/4 PATIENT'S HANDS SWELLED UP, ITCHING WOULD NOT STOP WITH BENADRYL FEET SWELLED UP TURNED YELLOWISH COLOR. MIGRATING JOINT PAIN (UNABLE TO CLOSE FINGERS DUE TO PAIN, KNEE HURT, ANKLES AND TOES HURT) TOOK TO ER. WAS ADMITTED FOR 2 DAYS. GIVEN ORAL STEROID, STRONGER ANTI-HISTAMINE (ATARAX 25MG EVERY 6 HRS) 11/7 FOLLOW UP WITH DR PEDIATRICS. GIVEN PREDISONE FOR 5 DAYS. SWELLING WENT DOWN. JOINT PAIN STILL MIGRATING (ONE DAY IT IS KNEE, NEXT DAY SHOULDER, ELBOW ETC TO A POINT WHERE SHE CANNOT MOVE THAT JOINT) 11/15 FOLLOW UP DR. RUNS ANOTHER FULL BLOOD WORK UP ON HER. SAW ALLERGIST. PATIENT IS ALLERGIC TO DUST. THIS WOULD NOT HAVE CAUSED THIS TYPE OR REACTION. (BLOOD WORK COMES BACK WITH NO MARKER FOR LYME, RHEUMATOID ISSUE, ILLNESS, STREP OR ANY OTHER UNDERLYING CONDITION.) TO THIS DAY, PATIENT STILL GETS SLIGHTLY ITCHY DURING COLD CONDITIONS, JOINT PAIN HAS SUBSIDED (LAST FLARE UP WAS 11/29) NO HIVES OR RASHES FOR 1 WEEK. HAS STOPPED TAKING ATARAX. IS STILL TAKING DAILY ZYRTEC AND PEPCID AS PRESCRIBED BY ALLERGIST. HAS FOLLOWED UP WITH 2 OTHER ALLERGY APPOINTMENTS WHERE THEY HAVE FOUND NOTHING AND HAS AN APPOINTMENT WITH INFECTIOUS DISEASE DR TO RULE OUT ANYTHING ELSE.
Patient given FLUZONE HD by Sanofi in left deltoid arm muscle using a 1 inch 25g needle and as soon as the needle left her arm a lump about the size of a fifty cent piece immediately arose at the vaccination site. Pt did not complain of pain.