chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Localized swelling, redness, warmth.  1 week post vaccine red welt remains present that is swollen, raised , red and warm. Area in question is about 2 inches x 2 inches.
received 1st dose, uknown if received 2nd; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose on an unknown date).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 15-Dec-2022 Reporter's comment: The pharmacist reported that a patient received first dose of Shingrix, but does not remember if she received the second dose or not.   The patient went to a pharmacy that was no longer open, and there was no records available.   Date of first dose was unknown. The reporter consented to follow-up. Additional supportive information: Till the time of reporting, the patient did not receive second dose of Shingrix, which led to incomplete course of vaccination. In worst approach, the case was kept valid with incomplete course of vaccination event considering the the patient did not receive the second dose.
6 days after first dose, developed pain behind R ear, down R neck, into R upper chest, elevated BP at 4:05 pm on 03/01/21. Admitted to ER for workup. Remained in Hospital for 25 hours.  All coronary tests negative. Tested positive for Covid-19 in ER
Itchy on face arms chest and trunk like I get when hives come on from gluten exposure  Occurred 40 min after took Zyrtec subsided a bit came on again at 75 min after &  gradually worsened took Benadryl at 1230. Itchy calmed at 230 & returned at 330 took more Benadryl at  730. Awaken at 630 this morning the itching is gone
Mother of this child contacted me on 9/5/02 stated that child noted to have a blotchy red rash this AM. Rash on chest area, around rib area to back. Few areas by wrists. Child denies any itching. No fever.
24 hours later sever dizziness; Injection site soreness; Internal itching; This is a spontaneous report from a contactable Other HCP.  A 40-years-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# unknown), intramuscular on 04Jan2021 10:00 at single dose for COVID-19 immunisation. Medical history included diabetes mellitus from an unknown date. Anatomical location was left arm. The patient experienced internal itching on 04Jan2021 10:15, 24 hours later severe dizziness on 05Jan2021, injection site soreness on 04Jan2021 10:15. The patient underwent lab tests and procedures which included covid-19 test on 05Jan2021 (unknown result). The events outcome was unknown. Information on the Batch/Lot number has been requested.
Incorrect dose of FLUZONE given (0.25 mL instead of 0.5 mL)
One week after my first vaccine I experienced swelling with a red, raised spot from the injection site radiating from my left shoulder to my left elbow.  I also had pain in my left arm, headaches and felt very tired and fatigued. I went to see my doctor who thought it was cellulitis and prescribe antibiotics. These symptoms lasted little over one week then they resolved.
autoimmune reaction; Eczema; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 2023SA040901.  A 92-year-old male patient received BNT162b2 (BNT162B2), in 2022 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; dupilumab (DUPIXENT), (Batch/Lot number: unknown) at first dose. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose number unknown, manufacturer unknown), administration date: 2022, for Covid-19 immunisation. The following information was reported: AUTOIMMUNE DISORDER (medically significant), outcome "unknown", described as "autoimmune reaction"; ECZEMA (medically significant), outcome "unknown". It was reported that "he believes his eczema is due to an autoimmune reaction from receiving the Pfizer Covid Vaccine regimen. He received two doses of the vaccine back in early 2022. No lab data was reported." The action taken for dupilumab was unknown. Case was assessed as not serious and Company agent (Private) casual was Yes.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.  No further information is expected.
"SITE OF INJECTION SKIN BECAME RED, PUFFY, PAINFUL, HEART RACING, WEAKNESS AND LEFT RIB CAGE PAIN, LASTED TWO HOURS, NEXT DAY SKIN WAS STILL RED AND PUFFY, SLIGHT TENDERNESS"  TIME IS APPROXIMATION.  PATIENT REPORTED INCIDENT 9/22/16 AT 11:30, REPORTS SITE OF INJECTION IS STILL SLIGHTLY RED, NO "PUFFINESS" NO PAIN.
The patient received PCV13 on 29 Sept 2020. The patient reported localized redness, swelling and lump under the skin to left deltoid around the injection site that occurred for several days after the injection. The patient reported the symptoms to medical provider during an appointment 07 Oct 2020, after the symptoms have resolved. There is a remaining small palpable lump under the skin at the injection site that the patient reports still itches.
positive for COVID; positive for COVID; cough; She felt lethargic and had a dull headache; She felt lethargic and had a dull headache; Her arm hurt the night of the vaccine and the following day; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program, Pfizer First Connect. This consumer (patient) reported similar events for two patients (patient's husband and patient). This is the first of two reports.   A 72-years-old female patient received first dose of bnt162b2 (BNT162B2, Lot EH9899), via an unspecified route of administration on 04Jan2021 at single dose for covid-19 immunisation. Medical history included cholesterol. Concomitant medication included pravastatin sodium (PRAVACOR) for cholesterol, levothyroxine sodium (SYNTHROID), she had been taking both at least 10 years and were ongoing. The patient experienced her arm hurt the night of the vaccine and the following day since 04Jan2021. She had been tested a few times. Tested and then came to local area. Quarantined for two weeks and test were negative. She had COVID testing on 11Jan2021 and got results were 13Jan2021. She experienced positive for covid on 11Jan2021, cough and she felt lethargic and had a dull headache on 06Jan2021, she had a mild case, did not have a fever, she went to the walk in clinic, had lungs checked, her oxygen level was normal, she had been testing normal, she did not have any severe symptoms of the COVID, she got post nasal drip and She started azithromycin on 11Jan2021. The patient was such a careful person. When she went to the supermarket, she wore a shield, mask, and gloves. She did not socialize, was home body. She had no idea how she got it. She did call her internist when she found out she had it. The patient underwent lab tests and procedures which included oxygen level: normal in Jan2021, oxygen level: good on an unknown date, COVID test: negative on an unknown date, COVID test: positive on 11Jan2021, lung checked: clear in Jan2021, testing: normal in Jan2021. The even outcome was unknown.
Diagnosed with diverticulitis after first dose; This case was reported by a pharmacist via call center representative and described the occurrence of diverticulitis in a 74-year-old female patient who received Herpes zoster (Shingrix) (batch number 4257F, expiry date 11th September 2021) and (batch number 7L355, expiry date 28th August 2021) for prophylaxis.   On 30th April 2019, the patient received the 1st dose of Shingrix. On an unknown date, the dose was an unknown dose. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced diverticulitis (serious criteria GSK medically significant). Shingrix was interrupted. On an unknown date, the outcome of the diverticulitis was unknown.   The reporter considered the diverticulitis to be unrelated to Shingrix.  Additional details were provided as follows: The patient was not able to get the second dose due to health issues. The pharmacist stated patient was diagnosed with diverticulitis after first dose of Shingrix but that was not due to vaccine. The reporter did not consent to follow-up.
Hep B vaccine pediatric dose used, not adult dose. No adverse effects reported. Repeated Hbv Adult dose on 4-27-17.
This spontaneous report as received from a registered nurse refers to multiple unspecified patients of unknown age and gender. There was no information about the patients' pertinent medical histories, concomitant medications and drug reactions or allergies provided. On an unknown dates, the patients were vaccinated with improperly stored doses of (Oka/Merck) VARIVAX (lot# L033138, expiration date 31-AUG-2017, dose, anatomical location and route of administration were not reported). There was no previous excursion reported, time frame was 13 days and 20.5 hours with temperature 0.5 Celsius degree. No adverse events were reported. Additional information has been requested.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Sep2022 at 12:00 as dose 4 (booster), single (Lot number: as7165b), in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Atrial Septal Defect repaired (amplatzer occluder)" (unspecified if ongoing); "Allergies" (unspecified if ongoing). Concomitant medication(s) included: PRAVASTATIN SODIUM, start date: May2015, stop date: 14May2023. Past drug history included: Clindamycin, reaction(s): "Known allergies: clindamycin"; Cefdinir, reaction(s): "Known allergies: cefdinir"; Lorzone, reaction(s): "Known allergies: lorzone". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received Paxlovid (14May2023 to 01Apr2023) as a treatment for Covid-19. Other medication in 2weeks: Yes
Headache FATIGUE Narrative:  MISSED WORK FOR SYMPTOMS  Other Relevant History:
This spontaneous medically confirmed report (initial receipt 23-SEP-2014) concerns a female patient. The patient had a medical history of allergy to "ampillin". The patient was not pregnant and was not receiving any concomitant blood thinners, diabetes medications or steroids. The patient received influenza shots in the past (for 10 years), without any reactions. On 11-SEP-2014, the patient received intramuscular AFLURIA injection (batch number T57005) in the left arm at a dose of 0.5 ml annually. On 11-SEP-2014, after vaccination, the patient developed a black marking. The patient developed a raised marking in the vaccine's injection site. The patient had a very fair skin and this was the first time it was noticed, therefore it may/may not have been there entire time. The marking was described as the head of an Energizer battery. It was black in color and about the size of a dime. It was not painful to touch. The marking does not appear red and there was no abscess or fluid. The patient could see the injection site where a black pinpoint was visible. There was no bruise. The patient had no fever or signs of infection. On 13-Sep-2014, the patient developed cold symptoms (runny nose) that resolved itself. The pharmacist reported that the patient might have received flu before the flu shot and it was manifesting now. As of 23-Sep-2014, the black marks had not faded or increased/decreased in size. The outcome was reported as not yet recovered.
I woke up  today, 4/23/21, with soreness around the injection site. The entire area is red, swollen and slightly itchy. It has been one week since I received the first dose.
Monovalent Pfizer (5-11 year old formulation) was administered to a 13 year old. Guardian was notified and counseled on administration error and will be back in 8 weeks to receive the correct vaccine formulation.
BRONCHITIS; This spontaneous report received from a health care professional concerned a 71 year old female. The patient's weight was 86 kilograms, and height was 148 centimeters. The patient's concurrent conditions included no tobacco use, and abstains from alcohol. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On JUN-2021, the subject experienced bronchitis. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of bronchitis was not reported. This report was non-serious. This case, involving the same patient is linked to 20210405798.; Sender's Comments: V0: Medical Assessment comment was not required as per standard procedure as the case assessed as non-serious.
Patient received expired vaccine. Local Health Department and Pfizer recommend revaccination. Patient was contacted to schedule an appointment.
At around 2am the morning after the shot or about 11hrs after; I began to feel ill with chills, headache, body ache. Did not check for fever but was clammy. Left arm was the most achy. On and off sweating occasionally caused by activity or no activity. Symptoms have lessened and are bearable at the 48 hour mark.
I was around my son and we did not know he had COVID-19. A couple days later, I started showing symptoms of a cough. The next day, I started to feel stuffy, congested, had body aches and continued to cough. Later that night, I developed a fever. I took a rapid COVID-19 test and it came back negative. My physician contacted me and told me the PCR came back positive. He prescribed PAXLOVID for me. I have been taking PAXLOVID since 12/14/2022. I have not noticed any positive change so I was thinking that I may discontinue taking it. I had a tele-health appointment this morning and my physician told me to continue taking PAXLOVID because it is the only medication available for me to take.
Dizziness; Nausea; This spontaneous case was reported by a non-health professional and describes the occurrence of DIZZINESS (Dizziness) and NAUSEA (Nausea) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Dizziness) and NAUSEA (Nausea). At the time of the report, DIZZINESS (Dizziness) and NAUSEA (Nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: low (Low) Low heart rate (within 10 minutes).     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was mentioned.  No treatment medication was mentioned.
Joint/muscle pain, numbness/tingling in wrist which started on the same day of getting vaccinated.
Angioedema, Urticaria, hives, shortness of breath  Developed facial swelling approx 3h after receipt of 1st-dose Moderna COVID-19 vaccine.  Subsequently developed hives and trouble breathing.
This is a spontaneous report from a contactable consumer (patient). A 46-year-old male patient received his first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; lot number: EL0142; expiration date: unknown), via an unspecified route of administration left arm on 13Jan2021 12:15 PM at a single dose for covid-19 immunization. The patient's medical history concomitant medications were not reported. The patient has no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient has not been diagnosed with COVID-19 prior to vaccination. The patient reported that he felt fine after the shot for the rest of the day and the first night other than the soreness where he received the shot. The patient went to bed around 11 pm and woke up the next day (14Jan2021) at around 6:30 am with very bad dizziness. He felt like his eyes were rolling around in his head which made him very nauseous and sick to his stomach. His wife called a friend who is a nurse and she said to keep an eye on him for a little while and see how he was in an hour or so. She said that if it gets worse call 911 otherwise get him to the clinic at 10 am. He reported that he was feeling much better by then but went to clinic at 10 and doctor saw him asked questions gave me something for nausea and dizziness. He felt good the rest of the day with slight lightheaded. He mentioned that he needs get his second shot on 03Feb2021 and was concerned about getting it. He inquired on what is the recommendation on getting dose #2. It was not reported if the patient been tested for COVID-19 since vaccination. The adverse event result in doctor or other healthcare professional office/clinic visit. The patient received treatment for the adverse events. They gave me ondansetron (ZAFRAN ODT [orally disintegrating tablets]) 4 mg for nausea. The patient considered the events was non-serious. The outcome of the events was recovered on an unspecified date with sequelae (recovered with lasting effects).
On the visit of 12/23/2019 Dr. ordered Pneumovax for the patient. Patient was given PCV 13 instead of Pneumovax. patient had received PCV 13 in the past dated 11/16/2017 ( PCV 13 lot # S 51635 NDC # 00005-1971-01
Pain in arm at injection site began on 1/18/05. Spread to thigh muscles, feet, hands. Pain keeps moving, but is not improving.  Has prostate inflammation so went to urologist on 2/3/05, but urologist said pain is not related to prostate. Will see primary MD on 2/5/05. Is taking Ibuprofen for pain. Also has fatigue.
It was reported that a 22 year old female patient received a JE-VAX vaccination on 01/17/01. Reportedly within one hour,the patient developed general malaise. The next day,the patient had 4.5 inch area of itching and redness at the injection site. The patient's recovery status was not provided.
The patient received the vaccine in the deltoid region of her right arm on 7/26. She presented to the pharmacy on 7/27 and had a reaction lower on the same arm, but not at the injection site. The reaction site was red, inflamed, swollen, warm, and painful. She was advised to use ice and benadryl.
Body aches, chills, fatigue, diarrhea, headache, nausea and belching. Pain in left chest.  Treatment consisted of bed rest. Currently feeling better but still tired.
pt recvd vax;running fever,3jan 5pm;pt felt very warm & would perspire;states lt leg became very red,swollen where shot was given;would not take bottle;was very cranky,crying for long periods;apap given q/ 4 hrs; no swelling or redness;
DOCTOR ALREADY NOTIFIED. Strong flu-like response with headache, muscle ache, slight fever, and exhaustion. Pain at injection site. Lasted for full 72 hours.
CHEST PAIN; BLURRED VISION; FEVER; This spontaneous report received from a patient concerned a 32 year old female. The patient's weight was 81.64 kilograms, and height was 160.02 centimeters. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 24-MAY-2021 13:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 24-MAY-2021, the subject experienced chest pain. On 24-MAY-2021, the subject experienced blurred vision. On 24-MAY-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 100.0. The action taken with covid-19 vaccine  was not applicable. The outcome of the chest pain, blurred vision and fever was not reported. This report was non-serious.; Sender's Comments: V0. medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
The pt developed an itchy rash that started 2 days, post vax. The rash had spread from his shoulder down his bicep and forearm.
1st vaccine, body aches, fever, headache, chills, nausea  all for 48 hours. 2nd vaccine same, but only lasted 36 hours.  2 weeks after my second shot, I went to the ER with a fib, heart rate 190 blood pressure 210/106. Was admitted, put on Metropolol and baby aspirin. Went home the next day. d dimer positive, but scans were clear.
This case was reported by a healthcare professional via a representative and described the occurrence of cellulitis in a subject of unspecified age and gender who was vaccinated with KINRIX, (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of KINRIX (unknown). At an unspecified time after vaccination with KINRIX, the subject experienced cellulitis. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the event was unspecified. The sales representative reported that there has been 4 cases of cellulitis at this doctor's office recently. They have increased their doses of KINRIX during this time and were questioning whether it may have been a cause. The sales representative had no additional information.
PATIENT HAS A 15.5CM BY 15CM CELLULITIC AREA TO UPPER LEFT ARM WHERE VACCINES WERE GIVEN. THE AREA IS RED, WARM, PAINFUL, AND ITCHY.
May 27,2018:  Seizure lasted about 2 minutes.  Paramedics came to house and took vitals and then an emergency room visit. postictal about 20 minutes. Put on ______(mg) medication. June 18, 2018:  Seizure while taking an EEG test.  Lasted about 5 minutes.  Post postictal about an hour. June 19, 2018: Seizure while on airline flight.  Lasted about 5 minutes.  Post postictal about an hour.  In flight emergency, ambulance and emergency room visit.  Released 4 hours later.  ______increased to 3 tablets (mg). June 26, 2018:  Seizure while passenger in a vehicle.  Lasted about 5 minutes.  Post postictal about an hour. July 9, 2018:  Medication putting patient into near coma.  Cannot stay awake. Vomiting with any food or  drink.  Emergency room visit.  Lower medication amount. August 31, 2018:  Seizure when waking up.  Unknown duration.  Post postictal about an hour.  Woke up in emergency room after ambulance ride.  Released several hours later. No events since August 31, 2018; however there has been dramatic side effects from the medication including irritability, shakiness with vomiting and upset stomach.   On 5-10-18 he was given Menvio Meingococal Lot #m17035 (Smith Cline)  (2nd shot) His first shot was Menactra (date unknown)
Normal initial soreness for first 3 days. Started itching around vicinity of injection site. Soreness returned which was more localized and noticed small bump under surface of skin, about the size of a golf ball, warm to touch and skin slightly red. Lot # is at home
Fully vaccinated with Moderna x2. Tested positive for Covid on 02/15/2022. Admitted to the Hospital on 02/14/2022 and was transferred to the Medical Center on 02/19/2022. Expired on 02/19/2022.
3.5 x 3 cm area of mild redness, warmth and itching to (L) deltoid (injection) area.