chrisvoncsefalvay/vaers-outcomes huggingface dataset:
face was swelling, bright red, and very itchy; face was swelling, bright red, and very itchy; face was swelling, bright red, and very itchy; Continued to worsen all day and night. Eyes and lips swelled shut; entire face and neck brilliant red; max amt of itching; neck still red and bumpy; Have been unable to sleep well; This is spontaneous report from a contactable healthcare professional (patient herself). A 63-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL3246), via an unspecified route of administration on 04Feb2021 at 15:15 PM (at the age of 63-years-old) as single dose in left arm for COVID-19 immunisation. The patient's medical history included diabetes Type 2, hypothyroid, shingles 10 years ago. Patient had known allergies. Concomitant medications included Synthroid, Rosuvastatin, Metformin, Tresiba and Ozempic. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient had no COVID prior vaccination and was not tested COVID post vaccination. On 04Feb2021 at 20:00 by midnight, the patient's face was swelling, bright red, and very itchy. She took one Benadryl. Her face and neck worsened, got into MD in morning. She prescribed Claritin and make appointment with allergist. Patient did both. Events continued to worsen all day and night. Her eyes and lips swelled shut, entire face and neck brilliant red with maximum amount of itching. Patient kept ice on face and neck all night but continued to worsen. She went into hospital Emergency Room at 9:00 AM, received IV Prednisone, Benadryl and one more. Also, prescribed with Famotidine, Prednisone, Benadryl and Tylenol if needed for home. Itching started subsiding, brilliant red remained everywhere, swelling was still significant around eyes and cheeks, neck was still red and bumpy. Patient have been unable to sleep well. She took appointment with allergist 08Feb2021 morning. She wondered if she should take second vaccine and reported that this has been an expensive and emotional nightmare. The outcome of the events was not recovered.
I felt fine the rest of the day. The next day I woke up from my sleep. I had very severe chills. I couldn't get warm at all. I had very severe nausea . I was vomiting. I received a fever of 102.7. Tylenol did not reduce my fever. I felt really terrible with body aches. I was hot at 9 or 10 in the morning. I still had on going nausea. I wasn't able to eat or drink until 1pm. I had soup that stayed down.  I took a prescription anti nausea pill which caused constipation. 7:30 at night everything stopped, but I still had a little bit of fatigue and mild nausea for the next week or 2. Telemedicine visit on March 4, 2021.
Chest pain. Difficulty breathing, upper back pain, numbness and tingling in right arm.
After vaccination was complete, patient went to sit down because she said she "felt a rush".  Pharmacist was called over and patient had her head between her knees while sitting in the waiting area.  She said she felt very dizzy but sitting forward wasn't helping.  Then about 30 seconds later patient stated she was going to pass out and wanted to lay on the floor.  While getting up she fell down and passed out, hitting her head on the cement floor.  911 called.  Patient came to about a minute later and stated she was going to throw up.  She spit a bit but didn't vomit.  She turned very pale and then turned bright yellow.  She was in and out a consciousness for a few minutes until paramedics arrived.  They examined her and took her to the er to verify if she had a concussion and make sure she was okay.
SICKNESS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced sickness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sickness was not reported. This report was non-serious. This case, involving the same patient is linked to 20221243764.
Sore muscle at injection site; Inflammation in both hands and wrists; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Lot 8731) via an unspecified route of administration in the right arm on 16Apr2021 (at the age of 55-year-old) as a single dose for COVID-19 immunisation. Medical history included rheumatoid arthritis. Concomitant medications included prednisone (MANUFACTURER UNKNOWN), trazodone (MANUFACTURER UNKNOWN), omeprazole (MANUFACTURER UNKNOWN) and bupropion (MANUFACTURER UNKNOWN) for unknown indication from an unknown dates and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Lot ER2613) via an unspecified route of administration in the right arm on 25Mar2021 at 12:30 as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 16Apr2021 at 14:00 the patient experienced sore muscle at injection site and inflammation in both hands and wrists. No therapeutic measures were taken as a result of reported events. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event vaccination site pain was unknown. The clinical outcome of the event inflammation was recovered on 16Apr2021 at 14:00.   No follow-up attempts are needed. No further information is expected.
Patient found unresponsive by babysitter. EMS called to scene. Patient transported to ER at Medical Center. Time of death noted to be 20:48 on 2/8/12 by ER.
190 patients (9 different lot numbers) received a vaccine past the beyond used by date; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (no adverse event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date).    No Concomitant medication was reported. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-704335 (Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704335:MASTER  CASE
This is a spontaneous report from a contactable consumer or other non-HCP (patient/himself). A 53-year-old male patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# EN6201, expiry date: unknown), at the age of 53, via an unspecified route of administration, on an unspecified date, single dose, for COVID-19 immunization. Patient previously took the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# EL9263), on an unspecified date, for COVID-19 immunization (patient experienced diarrhea). The patient's medical history and concomitant medications not reported. On unspecified date, patient had a very sore arm at injection site, flu-like body aches (no fever) and  diarrhea (day 2). The same thing reported after first shot. The outcome of the events: unknown. No follow-up attempts needed. No further information expected.
After receiving Hep A vaccine in right arm, patient felt dizzy and clammy, his right arm felt "numb" and "weak". After laying back, few minutes he was fine. His physical and neuro exam (right arm) was normal after few minutes.
nausea; vomiting; body aches; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (nausea), VOMITING (vomiting) and MYALGIA (body aches) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 11-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced NAUSEA (nausea), VOMITING (vomiting) and MYALGIA (body aches). At the time of the report, NAUSEA (nausea), VOMITING (vomiting) and MYALGIA (body aches) outcome was unknown. Not Provided          No treatment information was provided.
This case was considered medically important. Information regarding PREVNAR 13 was received from a healthcare professional regarding a patient who experienced high fever. The patient received a dose on 07-May-2010. Patient received PREVENAR therapy on 07-May-2010. It was reported on 10-May-2010, that the patient over the weekend had been treated at the hospital or was hospitalized with a high fever. Outcome was not provided. See related cases(s): US-WYE-H15094610 (adverse event, expedited) and US-WYE-H15094510 (adverse event, expedited).
today I feel kind of tired; last night I felt kind of bad; I didn't sleep well; developed a runny nose; sore throat; arm was a little sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was a little sore), RHINORRHOEA (developed a runny nose), OROPHARYNGEAL PAIN (sore throat), FEELING ABNORMAL (last night I felt kind of bad) and POOR QUALITY SLEEP (I didn't sleep well) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 038K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included AMLODIPINE, LOVASTATIN, ESOMEPRAZOLE MAGNESIUM TRIHYDRATE (NEXIUM [ESOMEPRAZOLE MAGNESIUM TRIHYDRATE]) and LISINOPRIL for an unknown indication.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm was a little sore). On 08-Aug-2021, the patient experienced RHINORRHOEA (developed a runny nose) and OROPHARYNGEAL PAIN (sore throat). On 09-Aug-2021, the patient experienced FEELING ABNORMAL (last night I felt kind of bad) and POOR QUALITY SLEEP (I didn't sleep well). On 10-Aug-2021, the patient experienced FATIGUE (today I feel kind of tired). On 05-Mar-2021, PAIN IN EXTREMITY (arm was a little sore) had resolved. At the time of the report, RHINORRHOEA (developed a runny nose), OROPHARYNGEAL PAIN (sore throat), FEELING ABNORMAL (last night I felt kind of bad), POOR QUALITY SLEEP (I didn't sleep well) and FATIGUE (today I feel kind of tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In August 2021, Body temperature: 98.6 (High) usually around 97.7 degrees Fahrenheit and it increased to 98.6 degrees Fahrenheit.         No treatment medications was provided by reporter.  On 09-AUG-2021 patient felt a little uncomfortable.   This case was linked to MOD-2021-282798 (Patient Link).
Rec'd DT on a Tues 7/29/08. On 7/31 (Thurs) developed rash on back. Days following, the rash spread to both thighs and abdomen. No increase temp no itch. Rash gradually fading. Reddened area at site of inj.
Expired Vaccine administered to patient; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Vaccine administered to patient) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939902) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Vaccine administered to patient). On 01-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Expired Vaccine administered to patient) had resolved.        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.   No Concomitant Medications were provided. No treatment  information was provided.  One vial of Moderna COVID-19 vaccine was taken out of the refrigerator, punctured and kept at room temperature (67.2F) beyond 12 hours. The vial was first punctured at 1:01PM on 31JUL2021 and that is when it was first moved to the room temperature.Patient number four received his first dose of Moderna COVID-19 Vaccine on 01AUG2021 at 11:27AM (10 hours and 26 minutes beyond punctured vial 12 hour expiration at room temperature).   This case was linked to MOD21-125492, MOD21-125573, MOD21-125575, MOD21-125577, and MOD21-125580, MOD-2021-273049 (Patient Link).
Cellulitis, injection site moving down arm. Antibiotic prescribed. Currently on antibiotic.
Passed out; stroke; her mouth, how she talks, her hand, her arms, her legs, and her brain are all affected; her mouth, how she talks, her hand, her arms, her legs, and her brain are all affected; her mouth, how she talks, her hand, her arms, her legs, and her brain are all affected; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 37-year-old female patient received second dose of bnt162b2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN, Batch/Lot number was not reported) via an unspecified route of administration on 06May2021 (at the age of 37-year-old) as dose 2, single for covid-19 immunization. Patient's relevant medical history included ongoing endometriosis, diagnosed since she was about 21 years old. Historical vaccine included, patient previously received first dose of bnt162b2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN, Batch/Lot number was not reported) via an unspecified route of administration on 15Apr2021 (at the age of 37-year-old) as dose 1, single for covid-19 immunization. On 27May2021 patient experienced Passed out, On unspecified date in Jun2021 stroke, her mouth, how she talks, her hand, her arms, her legs, and her brain are all affected. It was reported that patient had a stroke and states she did not have anything wrong with her, states she was good prior to the vaccination. Caller states 5 months ago (captured as Jun2021) had the stroke, still recovering. Caller states her mouth, how she talks, her hand, her arms, her legs, and her brain are all affected, states it is coming along but it was a bad stroke. Caller has difficulty coming up with some words and dates and numbers during the call. Reporter clarified that she was admitted to the hospital on 27May2021, stated she was in her house and she passed out. Stated her boss called her and she did not answer so her boss called her mom and her sister and when her sister called her and she did not answer, she came over to the callers house. Stated when they kicked the door in, they realized she was passed out and they found her that way and called the ambulance. Caller stated she was in the hospital for 16 days (till 12Jun2021), exact dates unknown, stated she went to rehab for 5 weeks after that, states she was home at the time of this report (reported as now) and she was continuing to recover and improve. Outcome of the events was recovering.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Loss of consciousness - possible breath holding spell vaccines (DTaP # 4 & Hep A # 2) given 2/21/11 at 11:40. On 2/24 - was sitting/crying - lost consciousness < 30 sec. No cyanosis.
no adverse event happened - patient got an extra dose of shingrix on 6/10/2023- on reporting system, it reported that he had gotten shingles vaccine on 7/9/2019 and 9/14/2019. The doses reported were 0.65ml on both. It was assumed he had gotten zostavax with extra dose as an error. After verification, it was learned he had gotten shingrix.
tremor on her left hand; This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team. The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 2, Manufacturer unknown), for COVID-19 immunization. The following information was reported: TREMOR (non-serious) with onset 2022, outcome "unknown", described as "tremor on her left hand". Additional information: Caller mentioned she has had a tremor in her left hand for over the last year (although it was not specified if it was due to the Pfizer-BioNTech COVID-19 Vaccine) and would like to know if after getting the shot there has been reports of unilateral or bilateral tremors in the upper extremities. She mentioned that this information would help her a lot to make a decision if the tremor might be a possible side effect for the COVID vaccine. She has been hearing in the news about tremors after getting the shot, but she doesn't know if this is scientifically true. She also said that she got booster and two regular shot and since it developed the tremor on her left hand. She is concerned about the tremor with the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt generally "not feeling right" some dizziness, week of stuffiness and pressure behind the eyes came to the ED for evaluation
Her arm was sore; This is a spontaneous report received from contactable reporter (Consumer) from medical information team. The reporter is the patient.  A 66-year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 13Feb2021 11:50 (Lot number: EL9265) at the age of 66 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Inflammation" (ongoing); "bone density" (ongoing); "acid reflux" (ongoing); "blood pressure" (ongoing); "Bone health" (ongoing). Concomitant medications included: RALOXIFENE taken for bone density (ongoing); OMEPRAZOLE taken for acid reflux (ongoing); LISINOPRIL taken for blood pressure (ongoing); VITAMIN D3 taken for extra D (ongoing); GARLIC [ALLIUM SATIVUM] taken for extra support (ongoing); TURMERIC [CURCUMA LONGA RHIZOME] taken for inflammation (ongoing); FAMOTIDINE taken for acid reflux (ongoing); CALCIUM taken for bone health (ongoing); COQ10 [UBIDECARENONE] taken for blood pressure (ongoing). The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 13Feb2021, outcome "recovered" (06Mar2021), described as "Her arm was sore".  Additional Information: Concomitant medication also included multivitamin (ongoing). The patient reported that after first dose, her arm was sore for a couple of hours but it was negligible. The patient had no history of all previous immunization with the Pfizer vaccine considered as suspect and no additional vaccines administered on same date of the Pfizer Suspect. The event did not require a visit to physician or emergency room. The patient had unknown prior vaccinations within 4 weeks. The patient had no family medical history and no relevant test done.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021263889 Same reporter, patient, and drug; Different dose and events
onset of trigeminal neuralgia in V1, V2 and V2 within 24 hours of 2nd dose.  Notably pt has hx of intermittent trigeminal neuralgia (3-4 previous flares in her lifetime) believed to be secondary to HVS infection.  Sx have been present for 2 days and associated with headache, fatigue and mild sore throat.   Pt will treat per usual with acyclovir 400 mg TID x 3-5 days.
Rash, hives, moderate itching. Continued until antihistamine taken 5 hours later. Continued to a mild degree even after taking antihistamine more than 24 hours later.
Patient stated that she became ill with fever (101 degrees) vomiting, Diarrhea, & Racing thoughts
After arriving home from the well visit our daughter within the hour started screaming uncontrollably (nothing I have ever witnessed), spiked a fever of 105. There was not consoling her or calming her down. She appeared to be in anguish and immense pain. The same evening she went to sleep for 14 hours. The days following she was lethargic and unresponsive.
reports 4-5 days of significant lymphadenopathy--swollen axillary lymph nodes and fatigue with dose number one. She did not seek medical care but did have concerns. Filing VAERs to document. She did have COVID-19 previously-more than 90 days before vaccination but could impact side effects.
05/15/2021 started with dizziness and the following day I had moments of imbalance, and other times as well. I went to my Neurologist about it and Vestibular Norites.  He gave me Prednisone for two weeks at a high dose and  Vestibular PT still on it.
Patient received monovalent 5-11 pfizer for a booster dose instead of bivalent 5-11 pfizer. No adverse event.
patient was doing ok until she received 2 vaccines, within minutes , she was flushed red and sweating down her back and felt pain in her chest .  She started to have pain go from her head down her spinal column and reported it on a level of 10/10.   she lied down where we could take care of her, she never lost consciousness and kept her talking, her pain level went down we she left to go to the hospital to a level of 5/5.