chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Chest pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A 58 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 26Aug2021 (Lot number: EW0169) at the age of 57 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "eczema" (unspecified if ongoing). There were no concomitant medications. The following information was reported: CHEST PAIN (non-serious) with onset 26Aug2021, outcome "recovered" (Sep2021), described as "Chest pain". The event "chest pain" was evaluated at the physician office visit and emergency room visit.  Additional information included: The report was related to a study or programme. The patient did not receive any additional vaccines administered on same date of the Pfizer Suspect. For the event Chest Pain, patient was not admitted to the hospital though. Prior Vaccinations (within 4 weeks) If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccines was None. Time the Vaccination Was Given: between 0800-0900. Expiry Date of Covid-19 Vaccine: Unknown. The patient did not receive other Products. He thought that, the chest pain started right after the vaccine and lasted few days after that. He clarified that it started immediately and continued on for about 10 days. Skin inflammation started after the second dose. He had a history of eczema and it caused him to flare up. It has improved and is under control now. It got out of control in the beginning of Nov2021. The patient Patient's Medical History (including any illness at time of vaccination): None. Family Medical History Relevant to AE(s): none. There were no relevant tests. Investigation Assessment: No.   No follow-up attempts are possible. No further information is expected.
This is a prospective pregnancy case. This 35-year-old female subject was enrolled in a study. The subject received the 1st dose of BOOSTRIX (intramuscular) 5 ml on 19th December 2014 16:00. On 19 December 2014, an unknown time after receiving BOOSTRIX the subject developed vaccine exposure during the pregnancy (Non-serious). The outcome of vaccine exposure during pregnancy was unknown. The pregnancy was ongoing.
after 30 minutes of observation patient was c/o tingling tongue.  Benadryl 50 mg given by Physician Assistant and patient was observed for 25 more minutes.  Patient stated she felt better and was released.
After vaccine that evening my head felt real dizzy and started having a bad bad headache like tightness in my head and felt like I was going to faint. I could hardly walk, my left arm got really tight feeling like a squeezing and it started getting really really red, then my heart started beating really fast and this never happens. Later that Friday night I felt like I had a fever I was up because my body started aching and was up all night, it felt like flu symptoms along with everything. My arm started getting very very sore and this went on Friday, Saturday, Sunday, Monday and Tuesday. My arm was still real tight and red and it moved down my arm these last couple days, down to my elbow, red very sore and tight. I took pictures because I was really scared on my cell phone but did not go to the doctor. Also, my vision started being blurry right now.
patient called on 9/27/19 stating she received the flu vaccine on 9/12/19 and that now her arm is sore. In the patient profile it shows that shingrix was administered on that date and no flu vaccine was received. The form filled out by the patient has the vaccine you would like to receive today area blank. I explained to the patient that she received the shingrix vaccine according to our records and that pain at the injection would be normal for the shingrix vaccine. She reiterated that she thought the vaccine was the flu shot. I also informed her that she was due for the shingrix and that now that she has had the first on she would be due for the booster in 2 months.
Starting 6 hours after the vaccine was given, I had severe pain that lasted for 3  full days and prohibited me from moving my arm.  It felt like my shoulder was broken.  The pain has mostly subsided, but I still do not have full range of motion.  In fact, I cannot take off my own shirt, because I can't do the movement of pulling and lifting my shirt over my head.  It hurts, but at  the same time feels like a pressure point that limits the movement.  Heat seems to make it feel better for a few minutes, as well as deep tissue massage - but this only lasts for a few minutes.  I feel handicapped.  At this point I DO NOT want the 2nd dose  because it could injure my shoulder more.  And I don't want it in my other arm for fear of having two arms that I can't use.
1305: Patient returned to clinic accompanied by his wife for possible allergic reaction. He had taken amoxicillin around 1245 and patient states no problems with amoxicillin usage in the past. At around 1300 when patient and his wife were leaving store parking lot, patient stated he did not feel right, began having all over skin itching, skin felt like it was "on fire", skin on neck and arms started to turn red, and patient started shaking. Patient was ambulatory to the exam room. Provider immediately assessed patient at 1305. He was alert and oriented, full body shaking, skin erythema on lower portion of face, neck, bilateral arms, chest, and abdomen without urticaria, and patient vigorously scratching his arms. Patient was assisted to supine position on exam table with vital signs completed. No stridor or wheezing noted, lungs clear to auscultation, tachypneic, and anxious appearing. Orders given for Benadryl 50 mg IM and dexamethasone 4 mg IM stat; Depo-Medrol not available in clinic. Erythema worsened in color with deep red all over body, sclera injected, full body shaking continued, and breathing became labored therefore order given for EpiPen administration. 2L NC applied with SPO2 99%. Hospital ambulance dispatched for ED transfer. 18-gauge PIV inserted right upper arm by this provider with NS 0.9% 1L bag initiated to run wide open. Patient reassessed multiple times with lungs remaining clear to auscultation, no stridor or wheezing, S1 S2. Patient denies shortness of breath and chest pain. Bedside report given to, Ambulance Paramedic at 1335. Patient left clinic at 1338 accompanied by Ambulance personnel x2 in stable condition including improvement in skin erythema, itching, body shaking, and respirations normalized; patient to be transported to hospital per patient request. 1308 vital signs: temperature 97.7 degrees F, HR 120, BP 156/88, RR 30, SPO2 98% on room air 1330 discharge vital signs: Temperature 97.9, HR 125, BP 152/90, RR 24, SPO2 99% on 2L NC
Patient called and reported that within 24 hours of injection she had swelling and itching at site of injection. The swelling with redness and itch subsided after 4-5 days. Advised ER if needed, BENADRYL, ice for comfort.
2.5 inch raised red welt formed the day after the shot, now gone down a bit but spread to 3X6 inches, "almost elbow to shoulder".  Still a little warm to the touch.  Still 1 inch red circle immediately around injection site. No fever.
Had some discomfort after the first dose; Had an itchy scalp and forehead; It started to look like a black and blue mark.; she has a small about 1/8 inch circle at the top of her injection arm; This spontaneous case was reported by a consumer and describes the occurrence of DISCOMFORT (Had some discomfort after the first dose), PRURITUS (Had an itchy scalp and forehead), VACCINATION SITE DISCOLOURATION (It started to look like a black and blue mark.) and VACCINATION SITE SWELLING (she has a small about 1/8 inch circle at the top of her injection arm) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, the patient experienced DISCOMFORT (Had some discomfort after the first dose), PRURITUS (Had an itchy scalp and forehead), VACCINATION SITE DISCOLOURATION (It started to look like a black and blue mark.) and VACCINATION SITE SWELLING (she has a small about 1/8 inch circle at the top of her injection arm). At the time of the report, DISCOMFORT (Had some discomfort after the first dose), PRURITUS (Had an itchy scalp and forehead), VACCINATION SITE DISCOLOURATION (It started to look like a black and blue mark.) and VACCINATION SITE SWELLING (she has a small about 1/8 inch circle at the top of her injection arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to US-MODERNATX, INC.-MOD-2021-101554 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-101554:
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Jan2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 39 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). There were no concomitant medications. Patient had no other medication in 2weeks. Past drug history included: Zithromax, reaction(s): "Known allergies: Zithromax", notes: Known allergies: Zithromax; Gabapentin, reaction(s): "Known allergies: gabapentin", notes: Known allergies: gabepentin. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: indication=Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 11Sep2022 to 16Sep2022. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
With long COVID Disease Symptoms; felt poorly for 1 day and she was fine the next day; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (With long COVID Disease Symptoms) and FEELING ABNORMAL (felt poorly for 1 day and she was fine the next day) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026d21A) for COVID-19 prophylaxis.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    No Medical History information was reported.   In November 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2022, received fourth dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and third dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On 21-Mar-2023, the patient experienced COVID-19 (With long COVID Disease Symptoms). On an unknown date, the patient experienced FEELING ABNORMAL (felt poorly for 1 day and she was fine the next day). At the time of the report, COVID-19 (With long COVID Disease Symptoms) had not resolved and FEELING ABNORMAL (felt poorly for 1 day and she was fine the next day) had resolved.            No concomitant medications were reported.  The patient reported that she received shot 4: 2nd Pfizer Booster dose on Fall 2022. She was not sure if this was a bivalent or not. She had COVID Disease from 21-MAR-2023 to 28-MAR-2023. She stated that on 13-NOV-2023, she still has COVID in her head, Dizzy, and Malaise. She also mentioned that after each vaccine she felt poorly for 1 day and she was fine the next day.  No treatment medications were reported.
This case was reported by a pharmacist and described the occurrence of a possible interferon alpha level increase in a subject of unspecified age and gender who was vaccinated with Hepatitis B vaccine (manufacturer unspecified). Concurrent medical conditions included scleroderma, systemic sclerosis and Raynaud's Syndrome. On an unspecified date the subject received unspecified dose of Hepatitis B vaccine (unknown). After vaccination with Hepatitis B vaccine, the subject experienced an immediate and very severe worsening of Raynaud's Syndrome. This may have been attributed to an interferon alpha level increase. At the time of reporting the outcome of the events was unspecified. It was noted that this event occurred in two subjects. Demographics were not known. Linked case is A0902892A.
10 pm 3/6 fever chills body aches nausea headache  7 am 3/7 nausea headache and syncope x 2 mins low blood pressure 90/60 x 48 hours thereafter
The excursion expiration date of 7 days (thawed in refrigerator) was followed because of the Pfizer email approving the 7 days. Policy was to follow the expiration of 5 days.
She feels a little warm; Constipated; She woke up and all her face is swollen; She feels tired; The injection site was in pain; Felt tired; She was completely swollen and inflamed her eyes; Her eyebrows were red; The injection site was hot; The injection site was inflamed; A swelling around her eyes; This spontaneous case was reported by a consumer and describes the occurrence of EYE SWELLING (A swelling around her eyes), EYE SWELLING (She was completely swollen and inflamed her eyes), HAIR COLOUR CHANGES (Her eyebrows were red), FEELING HOT (She feels a little warm) and CONSTIPATION (Constipated) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046AB21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Backache (She had been taking Meloxicam/ Metocarbamol previously for backache).    On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, the patient experienced EYE SWELLING (A swelling around her eyes). On 13-Apr-2021, the patient experienced EYE SWELLING (She was completely swollen and inflamed her eyes), HAIR COLOUR CHANGES (Her eyebrows were red), VACCINATION SITE WARMTH (The injection site was hot), VACCINATION SITE INFLAMMATION (The injection site was inflamed), FATIGUE (Felt tired) and VACCINATION SITE PAIN (The injection site was in pain). On 14-Apr-2021, the patient experienced FEELING HOT (She feels a little warm), CONSTIPATION (Constipated), SWELLING FACE (She woke up and all her face is swollen) and FATIGUE (She feels tired). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) ongoing since an unknown date for Pain, at a dose of UNK dosage form. At the time of the report, EYE SWELLING (A swelling around her eyes), EYE SWELLING (She was completely swollen and inflamed her eyes), HAIR COLOUR CHANGES (Her eyebrows were red), FEELING HOT (She feels a little warm), CONSTIPATION (Constipated), VACCINATION SITE WARMTH (The injection site was hot), VACCINATION SITE INFLAMMATION (The injection site was inflamed), SWELLING FACE (She woke up and all her face is swollen), FATIGUE (Felt tired), FATIGUE (She feels tired) and VACCINATION SITE PAIN (The injection site was in pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. Advil was taken for treatment. Patient had been taking Meloxicam/Metocarbamol previously for backache.
EBV virus; colds are much more intense and longer; This spontaneous case was reported by a patient and describes the occurrence of EPSTEIN-BARR VIRUS INFECTION (EBV virus) and NASOPHARYNGITIS (colds are much more intense and longer) in a  patient of an unknown age and 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 EPSTEIN-BARR VIRUS INFECTION (EBV virus) and NASOPHARYNGITIS (colds are much more intense and longer). At the time of the report, EPSTEIN-BARR VIRUS INFECTION (EBV virus) and NASOPHARYNGITIS (colds are much more intense and longer) outcome was unknown.            Concomitant medication was not provided.  It was reported that since patient had been carrying the EBV virus, patients colds are much more intense and longer. Patient was double vaccinated against covid and recovered. That has a certain reciprocity for patient overall.  Treatment medication information was not provided by the reporter.
pt keeled over followed by an opisthotonic episode by the time pt was picked up & carried into the examining room pt was alert & responsive; pt appeared upset, dazed & uncommunicative;
Covid-19 Booster-Induced Thromboembolism; falling; revealed left hip fracture; This is a literature report.  A 90-year-old male patient received COVID-19 Vaccine - Manufacturer Unknown, as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "Type 2 diabetes mellitus" (unspecified if ongoing); "Chronic kidney disease" (unspecified if ongoing); "Cerebrovascular accident" (unspecified if ongoing); "osteoporosis" (unspecified if ongoing); "prostate cancer" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: EMBOLISM (hospitalization, medically significant), outcome "unknown", described as "Covid-19 Booster-Induced Thromboembolism"; FALL (medically significant), outcome "unknown", described as "falling"; HIP FRACTURE (medically significant), outcome "unknown", described as "revealed left hip fracture". The patient underwent the following laboratory tests and procedures: Angiogram: demonstated concern for PE; Blood creatine phosphokinase: 1514; Blood creatinine: 2.18, notes: baseline-1.7; Blood pressure measurement: 126/61; Body temperature: 36.8 Centigrade; Computerised tomogram thorax: large central pulmonary emboli extending into ever, notes: large central pulmonary emboli extending into every lobi bilaterally and right heart strain; Heart rate: 87; Oxygen saturation: 87 %; 91 %, notes: improvement; physical examination: unremarkable; Respiratory rate: 24; Troponin: 1990; X-ray: revealed left hip fracture. Therapeutic measures were taken as a result of embolism.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of the reported events cannot be totally excluded.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
This spontaneous report was received from a other health professional refers to a patient of unknown age and gender. On 29-JUL-2013, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB (lot # J005575, expiry: 16-DEC-2015) dose 3. Dates of first two doses were unspecified. No adverse event reported. Additional information is not expected.
Induration, erythema right thigh 13cmx13cm surrounding injection site. Afebrile, pruritic. No significant tenderness; full weight bearing and ROM. Plan: Benadryl Elixir 6ml PO every 6 hours for 24-48 hours. Phone follow up.
broke up on hives all over, the worse part is on her stomach, also had on her leg, hands and head, basically everywhere.; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (broke up on hives all over, the worse part is on her stomach, also had on her leg, hands and head, basically everywhere.) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, the patient experienced URTICARIA (broke up on hives all over, the worse part is on her stomach, also had on her leg, hands and head, basically everywhere.). At the time of the report, URTICARIA (broke up on hives all over, the worse part is on her stomach, also had on her leg, hands and head, basically everywhere.) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product included  antibiotic, since 8 days ago but stopped Also she takes her usual medication  No treatment medication reported by the reporter
Redness, over 3?x2? at injection site and swelling at injection site.
chills; several side effects; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills) and VACCINATION COMPLICATION (several side effects) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CHILLS (chills) and VACCINATION COMPLICATION (several side effects). At the time of the report, CHILLS (chills) and VACCINATION COMPLICATION (several side effects) outcome was unknown. Not Provided          Concomitant product use was not provided by the reporter. Treatment information was not provided.
vaccinated with expired dose; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a patient who received HAV (Havrix) (batch number EK59B, expiry date 26th February 2022) for prophylaxis.   On 9th March 2022, the patient received Havrix. On 9th March 2022, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The registered nurse reported a patient being vaccinated on the day of reporting with Havrix which was already expired in 26th February 2022, which led to expired vaccine used. The health care professional did not give consent to follow up or provided any information regarding the patient. Also, health care professional was not aware if it was the first dose or the booster.
Tiredness and fatigue appeared first. Then nausea, dizziness, fainting, excessive sweating, and anxiety began within a few minutes. The whole event was over in about 20 minutes. Pain at the injection site also got worse around this time, and stayed for several hours after. Patient could not easily lift arm above their head.