chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pain, redness and swelling at the injection site; Pain, redness and swelling at the injection site; Pain, redness and swelling at the injection site. Swelling is about 4" in diameter; Feels warm to the touch even after 3 days after injection; Booster dose; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 29Oct2021 at 19:00 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of on an unknown date and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. On 30Oct2021, the patient experienced pain, redness and swelling at the injection site. The swelling was about 4" in diameter and felt warm to the touch even after 3 days after injection. The patient did not receive any treatment for the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events pain, redness and swelling at the injection site were unknown, while the clinical outcome of the events felt warm to the touch even after 3 days after injection was not resolved at the time of this report.    The lot number for BNT162b2 was not provided and will be requested during follow up.
Anaphylactic reaction; A spontaneous report was received from a consumer concerning a 28 year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and developed anaphylactic reaction.    The patient's medical history and concomitant medications were not provided.  On an unknown date, approximately three weeks prior to the onset of the event, the patient received her first of two doses of mRNA-1273 (lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection.   On an unknown date, the patient developed an anaphylactic reaction. Treatment information was not provided. The patient wanted to know if the Moderna vaccine contains shellfish and shark ingredients.   Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, anaphylactic reaction, was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset of the event, a causal relationship cannot be excluded.
7/25/06 about 3 minutes after receiving Adacel and Menactra, she complained of dizziness, fell down, started shaking with stiffed extremities, eyes rolling. She was fine afterwards but pt was sent to ER.
pt recv vax 29JAN97 post finger laceration;f/u 7FEB97 arm swelled up site of inj red & sore-quite large 3x3;red, inflamed, warm & indurated;rx Synalar cream sx gradually subsided;
heart palpations; tachycardia; hypertensive; diarrhea; headache; fatigue; This is a spontaneous report from a contactable consumer (patient) via medical information team. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 03Mar2021 as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported reaction after first dose and experienced heart palpations, tachycardia, hypertensive, diarrhea, headache, and fatigue, which were all non-serious on unspecified date in Mar2021. Outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Pain in chest above left breast; Tenderness in the area above and toward center; Couldnt sleep on side or stomach. Had to sleep on back so chest was more open; This is a spontaneous report from a contactable consumer, the patient. A 66-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EP7534), via an unspecified route of administration in the right arm on 23Mar2021 at 12:00 (at the age of 66-years-old), as a single dose for COVID-19 immunisation. Medical history included hypertension. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not have any allergies to medications, food, or other products. Concomitant medication included losartan (MANUFACTURER UNKNOWN) and fexofenadine (ALLEGRA); both for unknown indication from unknown date. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. On 23Mar2021 at 22:30, the patient experienced pain in her chest above left breast, tenderness in the area above and toward centre, couldn't sleep on side or stomach and had to sleep on back so chest was more open. It was not tightness and not hard to breathe. The events still present at the time of reporting. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome for the events pain in chest above left breast, tenderness and sleep disturbance were not recovered at the time of reporting.  No follow-up attempts are needed. No further information is expected.
I thought I had a cold, achy, runny nose, congestion. I thought I had better test since my wife, and I live in a 55 plus community. I used a home COVID-19 test that came back positive. I called my doctor to let them know I tested positive, they did not give me any medication since I had, had symptoms for three days before I tested myself. I was feeling better four days later. I tested negative ten days after my initial positive test.
Pt recv vax & devel inj site rxn w/2inch by 5inch area of swelling & erythema.
Caller states the patient has not experienced any adverse events; Pharmacist reports the administration of MMR II to a 71 year old male patient on 16JAN2023. Caller states this was 1 year after patient received stem cell transplant; This spontaneous report was received from pharmacist and refers to a 71-year-old.  The patient's medical history included stem cell transplant on an unspecified date in January 2022. The patient's concurrent conditions, concomitant therapies and historical drug were not reported.  On 16-JAN-2023, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, administered for prophylaxis (strength, dosage regimen, lot #, expiry date, and route of administration were not provided); and  varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, administered for prophylaxis (strength, dosage regimen, lot #, expiry date, and route of administration were not provided) (Contraindicated product administered)  Caller states the patient has not experienced any adverse events.
I contracted Covid-19. I developed cold/fever like symptoms. My eyes were dry and I had the sniffles. I also lost my sense of smell.
Pt got a flu shot on 9/23/2011 after 4 days her left eye started to turn red. The redness continued and after 2 weeks she started to lose vision in her left eye, after a few dr visits and with the start of vision loss in both eyes she was sent to ophthalmologist who diagnosed her with white dot syndrome (possible birdshot). He vision is returning but is still not normal as of 11/18/2011.
patient received vaccine, stated 'i feel a little dizzy' approximately 2 minutes elapsed after administration of vaccine patient was assisted to supine position and lost consciousness, continued to have pulse and breathing; LOC < 1 minute, physical touched and verbally aroused, was axo 4 upon reawakening remained in supine position, bp noted to 130/82, pale, breath sounds clear, RRR; pulse ox 95 patient felt improved and remained in supine position I left to retrieve water for patient, he was assisted to sitting positing with 2 assist and drank some water and agency report was initiated Patient again felt dizziness and was repositioned to semi reclined position, no second LOC but described tingling throughout body. Blood glucose was 309, pulse 54, blood pressure 100/70 at approximately 1205. EMS was called at 1306 and arrived at scene approximately 1315 at which time patient had good color, normal vitals with EMS evaluation. Was assisted to standing position by EMS without recurrence of symptoms and elected to proceed home with friend
Fever of 102.6, headache, chills approximately 12 hours after vaccine. Injection site  pain started 5 hours after vaccine.
Vaccine administered on 03/24/17. Redness at injection site on left leg started on 04/02/17, also had fever 102. Prescription for cephalexin given to parent for patient for 5 days.
10/2/12 pt got DTAP & Flu shot left upper arm & 10/3/12 about 10am got injection site red/warm/swollen & painful (no fever) & a lot better 10/4/12 after BENADRYL & ice application.
Information has been received from a pharmacist concerning a female who in the past was vaccinated with a dose of MMR II. Subsequently the patient was not immune to rubella. The patient was tested from titers which showed that she had not responded to the rubella portion of the vaccine. The patient was in contact with the nurse practitioner for medical attention. No further details. The outcome was unknown. It was noted that the patient brought in a prescription for HPV-77 (MSD) to the reporter. There was no product quality complaint. Additional information has been requested.
Adacel given 12/18/06, onset of severe pruritis the following day (localized to palms and soles) and was seen 1-4-07 and 1-15-07 for persistent itching. No other new meds or significant illnesses. On Keflex.
On 02/16/05 at 8:00 PM, patient complained of painful right arm, hand and shoulder. She also had neck pain and fever during night. On 02/17/05, she experienced severe swelling to the right upper arm with redness and warmth to the touch. Referred to private physician .
Rash on back-3 papulo vesicular lesions, itching x 24 hrs.
At 2:00 p.m. on 10/06/18 started getting scalp itching all over head. At 03:00 a.m. 10/07/18 awoke with more severe scalp itching and rash all over my lower stomach area and groin area. 07:00 a.m. 10/07/18 starting to get rash (hives) on wrist area of hands. Itching all over body!
Stomach pain, bloody stool, diarrhea up to 7 times a day, arm pain lasting for weeks.
not able to reconstitute the hib portion to the liquid portion with no reported adverse event; Initial information received on 25-Mar-2022 regarding an unsolicited valid non-serious case received from a other health professional via call center.  This case involves a 36 months old male patient that reported not able to reconstitute the hib portion to the liquid portion with no reported adverse event while receiving vaccine Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(MRC5)/HIB(PRP/T) Vaccine [Pentacel].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On 25-Mar-2022, the patient received a dose of Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(MRC5)/HIB(PRP/T) Vaccine(formulation and Strength:unknown) a dose of 0.5ml(millilitre) (lot U7054AA and expiry date: 18-dec-2022) via intramuscular route in the left thigh for immunization.  On an unknown date, the patient reported not able to reconstitute the hib portion to the liquid portion with no reported adverse event (product preparation issue) (unknown latency) following the administration of Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(MRC5)/HIB(PRP/T) Vaccine  It was reported "Pentacel vaccine need to be repeated as the liquid portion (DTAP -IPV) component was the only one administered to a pediatric patient and they were not able to reconstitute the hib portion to the liquid portion".  Action taken: not applicable.   At time of reporting, the outcome was Unknown for the event product preparation issue.    This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
This spontaneous report was received from a registered nurse refers to a 5 year old patient of an unknown gender. The patient's concurrent conditions and medical history were not provided. On 10-NOV-2015, the patient inadvertently received concomitant doses (unspecified in series) of M-M-R II, subcutaneously injection, 0.5ml, lot # L009212 and expiration date 17-MAR-2017 and PROQUAD (Merck), subcutaneously injection, 0.5ml, lot # L008353 and expiration date 11-SEP-2016. There were no concomitant medications reported. The patient did not seek medical attention. Additional information has been requested.
My left arm was sore with any movement for almost 48 hours.  The afternoon after my vaccine I didn't feel great then I developed tachycardia, dry heaves and broke into a cold sweat.  The event lasted between 1.5-2 hours.
Hives, flushing, headache, itchiness began about an hour after administration of the vaccine Tylenol, Famotidine Symptoms began to subside about 20 minutes after administration of medication
Patient was admitted on 10/3/2021 with neutropenic fever secondary to chemotherapy that he received for salivary gland cancer.  He received casirivimab-imdevimab on 10/4/2021.  He developed hypoxemia on 10/5/2021 and required 1L of oxygen.  He was still febrile on this date so he was started on dexamethasone and remdesivir.  He completed 5 days of remdesivir and dexamethasone while hospitalized.  He was discharged on 10/9/2021 with an Rx for the remaining 5 days of dexamethasone.
3 days ago with onset of other symptoms he had multiple episodes of dark diarrhea incidentally COVID positive, denies associated symptoms.   Janssen vaccine 5/15/2021 lot number unknown. given at facility
Severe sore throat...high fever...chills..red eyes that felt like sand was in them.
Inconsolable, crying for hours, rash that was at and around injection site. Rash disappeared for a few days then returned for a few days.
No additional AE reported; an expired MMR II vaccine was administered to a patient; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. Information about pertinent medical history, drug reaction/allergy and concomitant medication was not provided.       On 22-MAY-2014, the patient was vaccinated with an expired measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (0.5 ml, lot # H010136, expiration date 17-MAY-2014; strength, route of administration and anatomical location were not reported) for prophylaxis (expired product administered). No additional adverse event was reported (no adverse event).
7MAY91 started rash on cheek spot then rash progressed to face & legs, 9MAY91 states rash starts out a small bump then progresses to white pustule, then scabs over; poss chicken pox, rash on all extremities;
bumps on arms,bumps on chest,bumps on upper bra area; This spontaneous case was reported by a consumer and describes the occurrence of MASS (bumps on arms,bumps on chest,bumps on upper bra area) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MASS (bumps on arms,bumps on chest,bumps on upper bra area). At the time of the report, MASS (bumps on arms,bumps on chest,bumps on upper bra area) outcome was unknown.            No concomitant medication was reported. No treatment medication was reported.  Action taken in response to Moderna Covid 19 vaccine (mRNA 1273 vaccine ) is not applicable
Mother noted a large lump on the uppper right arm a few hours after the shots were given. Mother described the lump as hard, red and hot. Pt also had a low grade fever that came down with Tylenol. Saw Dr the next day and was given an Antibiotic to treat an ear infection and a staph infection at the injection site. Also had fever day after injections given. Two days after shots administered no fever reported and redness and warmth going down.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient had no known allergies and had received other vaccination in 2 weeks. The patient did not receive other medication in 2 weeks. Paxlovid was given as treatment for COVID-19 from 24Oct2023 to 29Oct2023.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
12 hours after shot I was chilling to the bones and felt weak. Had no appetite and just wanted to sleep.
Systemic: Tachycardia-Medium, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: patient described feeling of "electrical sensation" in chest, states she has heart issues and followed up with cardiologist who thinks it may have been due to flu shot
Aches all over body, especially in joints, itching in arm, rash on left arm, and injection site swelled up. Symptoms have gone on for two days.
Pt is brought by Mom, had vaccination on 1/20/09. Mom noticed swelling right thigh yesterday. No fever. Groin - right thigh - mild swelling and erythema and mild itching.
Had both shots but still got shingles/Suspected vaccination failure; Shingles; Painful shots; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Had both shots but still got shingles/Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles) and pain (Verbatim: Painful shots). The outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not reported.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and pain to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK receipt date: 14-MAR-2023 The case was received from the patient interactive digital media. The patient had both painful Shingles shots but still got shingles.  The patient asked, how common is that? This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Adhesive Capsulitis or Frozen Shoulder, which included great pain as well as loss of range of motion in my right arm
Headache; Rash/rash and the splotches on his wrists had resolved; Chills; Threw up; Big red splotches on his both wrists; Soreness at injection site; Lump around injection site about the size of a small marble; This is a spontaneous report from a contactable consumers (the patient and his wife). A 71-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EL9265; Expiration Date: May2021) via an unspecified route of administration in left arm on 28Jan2021 at 12:00 PM (at the age of 71-years-old) as 1ST DOSE, SINGLE for covid-19 immunisation (reported as to build up immunity to Covid-19) at hospital. Medical history included Diabetic, Pancreatic carcinoma, Blood pressure high, Whipple surgery (11 year survivor, tumors were encapsulated, had Whipple surgery) from an unknown date and unknown if ongoing. The concomitant medication were not reported. There were no history of previous immunization with the Pfizer vaccine considered as suspect. The patient did not take any other vaccinations within four weeks prior to the first dose. On 28Jan2021, on the way to home after vaccination at 12:00, the patient noticed a lump around the injection site about the size of a small marble. Around 21:30, he started getting a slight headache, then broke out in a rash under his arms and down his chest; looked like small chicken pox. He also got slight chills, and threw up once, and had big red splotches on both wrists. The consumer called their doctor friend, who told him to take two Benadryl, which he did. He then fell sleep in his recliner until about 3:30 next day. Then he went to bed and woke up about 5:30-6:00 and now seems fine. He just had a little soreness around the injection site. The patient further stated that the rash went away after taking the Benadryl, it almost cured him. He only threw up once and hardly ever throws up. The rash and the splotches on his wrists had resolved, then clarified that there night be a real slight redness on his wrists and where the rash was. He further stated that the soreness at the injection site was just muscle soreness. The consumer wanted to know if he should get the 2nd dose. The AEs didn't require a visit to Emergency room/Physician office. The outcome of the event soreness at the injection site was not recovered and all other events were recovered on 28Jan2021.  Follow-up attempts are completed. No further information is expected.
Patient initially had typical post vaccination symptoms of chills, fever, and fatigue. The following day post vaccination began  having tenderness to her right axilla area the day after vaccination on 02/26/2022. She then additionally noticed swelling, tenderness, and radiating pain since that time. Her pain is currently a 8/10. Pain is located to her right axilla area with tenderness and pain to surrounding region. the pain radiates to the top of her right breast, to her upper right back, and occasionally down her arm.
11/19/21: received Covid booster dose 11/20/21: Redness to buttocks started, skin started exfoliating and then completely peeled off on the left side of buttocks.  Blistered and red on the right side.  A spot developed on his neck that blistered and the skin came off.  Clothes were removed, aquaphor applied every 1-2 hours. 11/22/21:  Areas continued to enlarge and were painful.  Desitin (zinc 40%) ordered BID and prn, silver sulfadiazine BID, as well as Aquaphor 11/23/21: temp 99, skin still coming off and painful to touch