chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Nausea; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 18Feb2021 at 13:30 (at the age of 54-year-old) as a single dose for COVID-19 immunisation. Medical history included bipolar disorder, allergies, blood cholesterol abnormal (factor v cholesterol) and blood pressure abnormal. The patient had no allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included venlafaxine hydrochloride (EFFEXOR), carbamazepine (TEGRETOL), bupropion hydrochloride (WELLBUTRIN) and montelukast sodium (SINGULA) and  had received within 2 weeks of vaccination for an unknown indication. On 20Feb2021, the patient experienced nausea. The event did not resulted in doctor/other health care professional office/clinic visit and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the reported events. The clinical outcome of the event nausea was not resolved at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Mother reported redness, inflammation, and warm to touch to Left arm started on 4/4/2018 at the evening hours. Mother started applying BENADRYL to site as well as BENADRYL orally along with ice packs to area. School nurse made assessment of area on 4/5/2018 and noticed the redness to area with inflammation and warm to touch approximately 19 to 20 cm. circumference which was localized to the left arm. At this time nurse refer child to MD. Child was absent from school on 4/6/2018. Teleconference with mother stated following recommendations from an MD in another country. 4/9/2018 nurse made assessment of left arm, and noticed no redness, no swelling and skin temperature WNL.
Sore arm - five hours after vaccine Body aches/slightly elevated temperature- eight hours after vaccine Chills/vomiting - nine hours after vaccine
Initial unsolicited report received from a consumer on 22 November 2016. This case involves a 66-year-old male patient, who was vaccinated with a dose of FLUZONE Quadrivalent batch number: UI444AB, expiry date: 30 June 2016, dose, dose in series and route of administration were not reported) in right deltoid on 07 October 2015. Patient's illness at time of vaccination was reported as none and Pre-existing physician diagnosed allergies, birth defects, medical conditions was reported as Allergies: none. Concomitant medication was not reported. On 07 October 2015, same day following the vaccination, the patient developed bottom side tongue swelling and had some difficulty swallowing. Lab data was reported as none. Corrective treatment was not reported. On an unspecified date, the patient difficulty of swallowing was recovered on its own and tongue swelling was not recovered. List of documents held by sender: none.
After dose administration, while waiting during the 15 min observation period, the patient stated that he did not feel well. The pharmacist asked the patient to have a seat and applied a cold, wet towel to the back of his neck. While seated the patient became pale, began sweating and became unresponsive for about 10- 15 seconds. After the 10-15 seconds the patient began to rise up and response to his name being called. 911 was called and  the patient was evaluated for vitals. The patient declined hospital transfer and waited for his with to pick him up.
Information has been received from a nurse practitioner NP concerning a 17 month old male with protein losing gastroenteropathy who on 2/17/2005 was vaccinated SC in the right arm with the first dose of varicella virus vaccine live (lot 648054/0195P). There was no illness at the time of vaccination. The NP reported that on 7/26/2005, the patient developed 10-20 pruritic red macular lesions in different stages on his trunk, extremities and face. No other symptoms were noted. New eruptions were observed in a 24 hour period. Medical attention was not sought and treatment or lab/diag test were not required. On 7/30/2005, the patients lesions resolved. Additional information is not expected.
The patient stated that a few days following his 1st covid vaccine he developed a rash on his chest and left arm. He went to the doctor and they diagnosed him with shingles. Patient is still experiencing actue rash.
Fatigue.    I am never that tired and did nothing the days before to warrant that kind of wiped out feeling.  Got that wiped out feeling all day long.  Took 4 hours total in naps, and still slept like a rock all night.  The day after that, (March 5th) I felt super great.  Just wanted it to be known.
Severe chills; rapid heart rate; muscle aches; fever; insomnia; headache; This is a spontaneous report from a contactable pharmacist (patient) reporting herself.  A 58-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EL1283), dose 2 via intramuscular route of administration, administered in Arm Left on 03Feb2021 at 11:30 (at the age of 58-year-old) as SINGLE DOSE for covid-19 immunization. The patient received first dose of bnt162b2 (Lot number: unknown) on an unspecified date as SINGLE DOSE for covid-19 immunization. Medical history included hypothyroidism and seasonal allergy. The patient had no allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included estradiol (ESTRADIOL); progesterone (PROGESTERONE); citalopram (CITALOPRAM); thyroid (ARMOUR THYROID); levocetirizine dihydrochloride (XYZAL). Patient was not diagnosed with COVID 19 prior to vaccination. On 04Feb2021 at 01:00, the patient experienced severe chills, rapid heart rate, muscle aches, fever, insomnia and headache. The patient reported the seriousness s as non-serious. The Patient has not received any treatment for the adverse event. Since the vaccination, patient not been tested for COVID-19. The outcome for the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Patient was given a COVID-19 pediatric vaccine and is not 5 years old yet.  Error was realized within minutes of vaccine being given by MA
Rash in both arms, right leg, belly Next day on neck, Bach, thighs, blisters all over
Information has been received on 02-JUL-2018 regarding a case in litigation from a lawyer and a male consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. In 2007, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route at a clinic, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. In 2015, the patient was treated at a clinic for a blistering vesicular outbreak, which was then diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX and/or despite receiving the 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.
rt arm slightly swollen from shoulder to elbow; raised welt-like areas on arm; sl warmer than nl to touch; pt states sx started prior to receiving vax, become worst p/vax;
At 2030 I noticed suddenly my cheeks felt like they were on fire and were bright red.  This lasted for about 2 hours.   I had chills for 3 hours.  My arm was pretty sore for around 24 hours.  The arm soreness started about 3 hours after the shot.  No redness at shot site.  I took 1000 of tylenol at 2200 that night.  I took another 1000 of tylenol at 0900 the next day.   I took 1000 of tylenol at 1700 the same day as 0900 dose due to arm pain.  I felt foggy all day the day after I got the vaccine.   I just didn't feel right.   It's hard to explain. I just felt like I was off!
The child received a DTaP vaccination on 04/30/2010. Injection site became erythematous, warm and painful to the touch by the next morning. On 05/02/2010, the erythematous area enlarged and the child was taken to a local ER for evaluation. He was diagnosed with acute cellulitis and given a prescription for Duricef. By the time the parents filled the prescription, the child had fallen asleep and when he awoke several hours later, the redness and warmth had begun to resolve (no antibiotic had been administered). The parents did administer the antibiotic and on the child's presentation to the Pediatric Clinic on 05/03/2010, the erythema, tenderness and warmth had completely resolved.
Dizziness and nausea within 7 minutes of receiving vaccine. 6 Hours after vaccine severe arm pain, sensitive to touch, movement and unable to lift arm beyond 45 degree angle. 17 hours after vaccine chills, fever of 102, muscle aches, severe headache, fatigue. 53 hours after vaccine, fever 101, severe headache, muscle aches, fatigue. Arm pain much less severe.
MOTHER CALLED NURSE ON 10/25/12 AT 12:15 PM AT HD TO REPORT CHILD DEVELOPING A HIVE ON RIGHT UPPER ARM AT 6PM ON 10/23/12. ON 10/24/12 MOTHER GAVE CHILD IBUPROFEN 200MG X 2. AT 8:30 AM AND TYLENOL X 2 AT 11:30 PM. THE HIVE IS NOW DOUBLE THE SIZE: 2 1/2 INCHES X4 1/2 INCHES PER THE MOTHER. MOTHER ALSO GAVE CHILD BENADRYL 25 MG. AT 9PM ON 10/24/12 AND 50MG ON 10/25/12 AT8:30 AM. IBUPROFEN 200MG X 2 TABLETS WAS ALSO GIVEN ON 10/25/12 PER THE MOTHER.
low blood pressure; tired every time afterwards, "I feel so crappy; low blood sugar; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HYPOTENSION (non-serious), outcome "unknown", described as "low blood pressure"; FATIGUE (non-serious), outcome "unknown", described as "tired every time afterwards, "I feel so crappy"; BLOOD GLUCOSE DECREASED (non-serious), outcome "unknown", described as "low blood sugar". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: It was reported that when the patient gets the vaccine she had low blood pressure and wants to know how to limit and if she should take another dose. Caller said she has had 5 shots so far and was debating about getting the next dose. Caller said she was tired every time afterwards, "she feel so crappy". Caller also said that it may be low blood sugar causing her to feel poorly after the vaccine dose. Caller asked if there was a way to manage the low blood pressure effects from the vaccine. Caller asked if there was any information on low blood sugar after vaccine dosing?  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Hospitalized COVID-19 Infection admitted to the hospital internal medicine service in the context of chills and malaise over 3 days.  His creatinine was found to be 12 and he was also hypokalemic.  He is being admitted to the CICU for dialysis needs
Told Mom and patient were getting MENACTRA and GARDASIL shots. After patients get vaccinations had to stay in room because could get dizzy from GARDASIL. After GARDASIL was administered, leaned table so patient could lay down. Patient was sitting on exam table when I turned around for 1 second to grab my notepad. Patient fell face forward on floor and was bleeding. She had a seizure for less than a minute.
swollen lymph nodes under both arms particularly on left side where he got the shot is the size of an eggplant almost; rapid elevated heartbeat; Why was the patient taking Pfizer Covid 19 (booster) (Verbatim): eligible; Covid 19 Virus; This is a spontaneous report from a contactable consumer (patient). A 65-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0169), via an unspecified route of administration, administered in left arm (left shoulder) on 07Oct2021 (at the age of 65-years-old) as dose 3 (booster), single for COVID-19 immunisation. Medical history included ongoing high blood pressure (Stated that it was quite some time ago before the shot. Is hereditary and runs in his family. Is a marathoner. Stated that he got back on it just last month after being off of it for years because he managed it well. Patient clarified that he was never diagnosed as hypertension because he was always high number and stated that recently parameters for high blood pressure has changed). Concomitant medications included enalapril maleate (VASOTEC [ENALAPRIL MALEATE]) taken for high blood pressure, start and stop date were not reported; amlodipine (MANUFACTURER UNKNOWN) taken for high blood pressure from 21Sep2021 and ongoing. The patient previously took first and second dose of COVID-19 vaccine (MANUFACTURER UNKNOWN) on an unspecified date for COVID-19 immunisation. The patient took Pfizer Covid 19 (booster), eligible for Covid 19 Virus. Patient received the booster on Thursday of last week (07Oct2021), and on 08Oct2021, within 24 hours of vaccination, that patient experienced swollen lymph nodes under both arms particularly on left side where he got the shot is size of eggplant almost and rapid elevated heartbeat. The patient stated that he was having some side effects. Stated that he got the booster on Thursday of last week. Stated that he had swollen lymph nodes under both arms particularly on left side where he got the shot is size of eggplant almost and rapid and elevated heartbeat. Clarified that it is for the Pfizer Covid 19 booster. Stated that he was concerned because he contacted his physician but he is out of the office for the remainder of the week. Stated that it is severe with swollen lymph nodes. Stated that he had no issues previously. Wanted to know if the first two shots are similar to the booster. He was a runner and went for a Saturday run and it settled a bit. Stated that he woke up this morning and it is still elevated. Stated that he was on Vasotec intermittently when his blood pressure was elevated. Stated that it was managed and he stopped taking it. The patient underwent lab tests and procedures which included heartbeat: rapid elevated on an unspecified date. Treatment was not received. The clinical outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
bad headache; body aches; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (bad headache) and MYALGIA (body aches) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041B21A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma. Concomitant products included CICLESONIDE (ALVESCO).    On 12-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 1. On 13-Apr-2021, the patient experienced HEADACHE (bad headache) and MYALGIA (body aches). At the time of the report, HEADACHE (bad headache) and MYALGIA (body aches) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information not provided.
Patient reports she received the first dose of Moderna vaccine on 4/5/21. Two days after the vaccination (on 4/7/21), patient experienced swelling in the lymph nodes in her neck and arms. This progressively worsened to include swelling of her legs and achy joints. Patient has underlying autoimmune health conditions. Patient had to seek medical help through a Rheumatologist for treatment for her leg swelling (lymphedema). Patient is currently taking steroids and the condition is improving. Patient does not want to accept the second Moderna vaccine at this time, will discuss further with her PCP.
24hr p/vax pt seemed more tired;36hr p/vax 2 brief self limited 4 extremity shaking spells not assoc w/fever;
From initial information received on 05/29/03, from a health care professional regarding an adverse event occurring in the USA, it was reported that a female pt received a TD ADS ADULT vaccination, Lot # U0824AA, administered in the left deltoid on 05/22/03.  An unspecified time later the pt developed local redness, swelling, warmth and induration at the injection site. It was reported that the pt was afebrile at the MD visit, but then reported fever and swollen lymph nodes. The recovery status of the pt was not reported.
pt recvd vax & 1hr post vax pt exp hives & flushing;pt was seen by MD & probably treated w/Depo-Medrol;sx resolved;
This spontaneous report was received from a registered nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (dose, route, lot number, expiration date and dosage schedule were not reported). No adverse events were reported. Additional information has been requested.
Initial report received from a health care professional on 15/Jun/2010. A 27-year-old female patient, with a medical history of 6 weeks pregnant and on levothyroxine, metformin and prenatal vitamins, received a left deltoid intramuscular (IM) injection of 0.5 milliliters of ADACEL, lot number C3357AA, and experienced no adverse reaction. The patient was a Para 0/Gravida 1 with her last menstrual period reported as 28 May 2010. Follow-up information was received from a health care professional on 22 June 2010 who reported that the patient had a spontaneous abortion (date not provided). The patient had no illness at the time of vaccination which was on 07 June 2010. It was unknown if the patient had any adverse event following prior vaccination. The outcome was reported as unknown. Due to this new information received this case was upgraded to serious. Documents held by sender: None.
Monday receive the pneumococcal conjugate vaccine. Tues. call the doctor office on the 6/23/15 nurse told me to buy BENADRYL for allergies / was not seen. Wed. saw Dr. He said I had a bacterial infection not an allergy. Cephalexin take 1 tablet orally every 6 hours 500mg tablets.
Joint pain/swelling-current-Motrin, Celebrex (MRI), flu-like symptoms after each shot. Fatigue-low energy-easily tired regardless of sleep amount. Rashes-on hands, elbows, groin, face-steroid creams, unexp chest pain-went to ER-MRI, stress test. Numbness/tingling in feet, arms, hands and back-current.
The place where the shot was given experience pretty heavy sore and light pain. And now it's a bit better. Redness and swelling did NOT happen. Feels like after an intense shoulder workout and sore all day long.
8/19/22: The resident had some pink area at the site of the injection measuring 6.5cm x 6 cm. The resident denies any itching or discomfort at the injection site. The resident remains afebrile with a temp of 96.4. 8/20/2022: The pink area on the resident's left deltoid injection site increased in size it is now 8.5x10 cm and the resident is complaining that the area is beginning to itch. PRN Benadryl was administered 8/21/2022: Spoke with provider regarding area of concern to resident's left deltoid. Provider gave verbal order to continue with Benadryl, ice, compresses, and discourage the resident from scratching. Verbal order to denote boarders of the lesion with a marking pen. Observe carefully for signs of cellulitis and notify of changes. Left deltoid injection site increased in size 10 cm X 11 cm. c/o itching around the area. Red and warm to the touch. PRN Benadryl given and ice compresses apply. Discourage from scratching. Area mark with marker. 8/24/2022: Monitored for discoloration at injection site related to Covid booster on the left deltoid. Slightly red no increases in size. No acute distress noted at this time.
Large rash (2 inch diameter) appeared on arm at injection site exactly one week after first injection. Slightly itchy.
Itchy red rash on area where injection was administered.  Other arm also had slight rash, but left deltoid rash was much more prominent.
Left Arm at injection site lump. Also had eye spasms. Skin at site of injection is warm and itchy
Fatigue; body aches; Soreness in the arm around injection area; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41-year-old male patient received BNT162b2 (BNT162B2), on 12May2022 at 10:30 as dose 3 (booster), single (Lot number: FL3197) at the age of 41 years, in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose Number: 2, Batch/Lot No: EL3247, Location of injection: Arm Left, Vaccine Administration Time: 10:30 AM), administration date: 04May2021, when the patient was 40-year-old, for COVID-19 immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: EL3247, Location of injection: Arm Left, Vaccine Administration Time: 10:00 AM), administration date: 13Apr2021, when the patient was 40-year-old, for COVID-19 immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 13May2022 at 06:00, outcome "recovering", described as "Soreness in the arm around injection area"; FATIGUE (non-serious) with onset 14May2022, outcome "recovering"; PAIN (non-serious) with onset 14May2022, outcome "recovering", described as "body aches". Therapeutic measures were not taken as a result of vaccination site pain.  Additional information: The patient had received no other vaccines within 4 weeks prior to COVID vaccine. The patient had not diagnosed with COVID prior vaccination and the patient had not tested to COVID post vaccination.  No follow-up attempts are possible. No further information is expected.
This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. This spontaneous report refers to a 13 year old male patient. The patient had no pertinent medical history. No concomitant medications were reported. On 11-MAR-2016, the patient was vaccinated with the third dose of hpv GARDASIL 9, intramuscularly in the left arm, lot # reported as L036301 (expiry date was not reported) for prophylaxis. On 11-MAR-2016, the patient got lump under the skin which was warm to touch at injection site of left deltoid since administration date. The patient sought medical attention via emergency room visit. The outcome of the events was not recovered (also reported as per patient's mother lump seemed to be getting bigger). The relatedness between the events and GARDASIL 9 was not provided by the Agency.