chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a pharmacist refers to a 67 year old female. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 20-MAY-2017, the patient was vaccinated with ZOSTAVAX  (K003601 exp: March 2015) that was reconstituted with STERILE WATER DILUENT ( M031575 exp: March 2019).  On an unspecified date, it was reported  the injection site was "red, hard, and bumpy." No additional information provided. The outcome of injection site erythema, expired product administered, injection site mass and injection site induration is unknown. Lot number M031575 has been verified to be a valid lot number for sterile diluent. Additional information has been requested.
Started coughing and throat closed up 10 minutes after injection. Benadryl injection given onsite and ambulance called as symptoms returned. Receive steroids and more Benadryl in ambulance and then Pepcid in hospital.
After receiving her 2nd dose she felt drossy, headache in left eye, got red bruises behind her left leg. Inside right leg 2 bruises
This spontaneous report as received from a nurse reporting a 49 year old female patient. The patient was allergic to morphine. On 24-SEP-2013, the patient was vaccinated with a dose of PNEUMOVAX 23 (lot #3H021941, expiration date 11-JUL-2014), 0.5 ml, intramuscularly in left arm. Concomitant therapy was not reported. The patient developed redness, warmth, and swelling extending from the injection site towards her elbow a few hours after administration of PNEUMOVAX 23 on 24-SEP-2013. The patient also developed fever and increased sweating. The patient was evaluated in the office on 30-SEP-2013 by a doctor and was prescribed AUGMENTIN and prednisone for cellulitis. The patient was seen in her office again on 02-OCT-2013 and 04-OCT-2013. The symptoms were improving but the injection site was still warm and tender. On 11-MAR-2014, the patient was evaluated by physician assistant, who was with another doctor's dermatology practice, and was diagnosed with lipodystrophy at the injection site. She was recommended to massage the area and take MOTRIN. The patient was again seen by the doctor on 14-MAR-2014. She was diagnosed with a possible abscess at the injection site and had been referred to an unspecified infectious disease practice for evaluation. At the time of the report the patient was recovering from the events. The relationship between the events and PNEUMOVAX 23 was not reported. Additional information has been requested.
Late Friday night - developed hives in trunk area.  Saturday-Sunday: Hives slowly spread to limbs.  Periodic usage of Benadryl 2 times a day (late afternoon and night) reduced the bumps, itchiness and redness to some extent.  Would return and spread more by morning.
Pt began having aching joints in fingers. To date, this has progressed to knees, ankles, wrists, and 1 shoulder with some swelling in the joints. She also has fatigue. Pt has been limping for 9 days. Pt's MD does not know enough about her symptoms and referred pt to a rheumatologist. Pt takes ibuprofen daily.
Patient had 4 mm left frontal lobe stroke without any other known etiology on testing (heme, cardio, neuro consulting/workup); This is a spontaneous report from a contactable physician. A 35-year-old female patient (no pregnancy) received the first dose of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine, lot number: EL9267), intramuscularly at site of left arm at 16:30 on 16Feb2021 at single dose for COVID-19 immunisation. Medical history included hypothyroidism and autism spectrum disorder (ASD) (closed 12 years ago with NO sequelae). Concomitant medication included levothyroxine and valacyclovir [valaciclovir], both received within two weeks of vaccine. The patient had 4 mm left frontal lobe stroke without any other known etiology on testing (heme, cardio, neuro consulting/workup) at 13:15 on 20Feb2021. The patient was hospitalized for this event for 2 days. The adverse event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event), disability or permanent damage. The patient received treatment (Multiple MRI/MRI, TTE AND TEE, blood studies/holter study, new medicatinos) for adverse event. No covid prior vaccination. Covid was tested post vaccination. Covid test type post vaccination was blood test, covid test name post vaccination was Ig M/IgG with negative result on 24Feb2021. Covid test type post vaccination was Nasal Swab, covid test name post vaccination was Rapid with negative result on 24Feb2021. No known allergies. No other vaccine received in four weeks. The outcome of event was recovered/resolved with sequel.; Sender's Comments: Limited information does not allow a medically meaningful assessment for the event Stroke for BNT162B2. Details regarding the clinical symptoms, relevant test results, treatment medications and clinical course are not provided. At this time, the case is handled as related for reporting purposes. The case will be re-evaluated if more information is available.   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.
7/7/22 in the evening I started coughing a deep cough with pain in left lung. 7/8 Stuffy nose, deep cough, headache, and body aches progressed through 7/10. Took an at home Rapid COVID 19 test, strongly positive 7/09. Televisit with doctor on 7/10. Symptoms varied from very mild to moderate for about 2 weeks. One way was mild, and the next the symptoms were moderate. This lasted until 7/25, but symptoms are improving. Feeling better but still have a cough and stuffy nose, but mild.
Patient is a 43-year-old, male with a history of fear of needles. At 2:39 pm, the patient received a dose of the Janssen vaccine, (lot number 1808980, expires on 06/20/2021) on right deltoid, given by RN. Immediately following the vaccination at 2:40 pm, Patient reportedly slumped his head forward in his seat and was caught by RN, sustaining zero physical bodily injuries. The patient was unconscious for approximately 2 seconds. EMT'S responded immediately at 2:40 pm and took the patient's vitals. At 2:40 pm, the patients vitals were: 117 systolic BP and HR 89 (EMT unable to hear the diastolic BP due to environmental noise). The patient appeared diaphoretic, pale, with warm, clammy hands and a weak radial pulse. The patient was given a water and tolerated intake of water. The patient was assisted by EMT  to a anti-gravity chair at 2:43pm. The patient was observed to have a steady gait and reporting no dizziness. At 2:44 pm, the patient's vitals were: HR 54 and 110 systolic BP (EMT unable to hear the diastolic BP due to environmental noise). At 2:50, the patient had a strong, bounding radial pulse with a HR of 70 BPM and 115 systolic BP (EMT unable to hear the diastolic BP due to environmental noise). At 2:55 pm, the patient's vitals were: HR 75 BPM and 115 systolic BP (EMT unable to hear the diastolic BP due to environmental noise). At this time the patient reports feeling "better". At 3:00 pm the patient's vitals were: HR 81 BPM and 118 systolic BP (EMT unable to hear the diastolic BP due to environmental noise). At 3:05 pm the patient's vitals were: HR 77 BPM and 120 systolic BP (EMT unable to hear the diastolic BP due to environmental noise). At 3:10 pm the patient's vitals were: HR 74 BPM and 118 systolic BP (EMT unable to hear the diastolic BP due to environmental noise). At 3:15 pm, the patient was assisted up from anti-gravity chair. The patient had a steady and balanced gait. The patient denied any additional dizziness, lightheadedness, or nausea. EMT provided patient with education related to when to call his HCP (i.e. dizziness, itching of throat). The patient reported he was "ok to drive home" and left to the parking lot at 3:15 pm.
Swollen near armpit (left arm); Does hurt; This is a spontaneous report from a non-contactable consumer, the patient. A 27-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EWO15C) via an unspecified route of administration in the left arm on 14Apr2021 at 01:00 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any medication within two weeks of the COVID-19 vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 24March2021 (at the age of 27-years-old) as a single dose for COVID-19 immunisation The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 14Apr2021 at 16:00, the patient experienced swelling near armpit (left arm) which hurt. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events swelling near armpit (left arm) which hurt was not resolved at the time of this report.   No follow-up attempts are possible. No further information is expected.
The vial was first punctured on 19-Apr-2023 and admnistered on 25-apr-2023 and stored in fridge post puncture.; No adverse event; Bivalent Vaccine that was punctured 19Apr2023 and administered on 25-Apr-2023; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Bivalent Vaccine that was punctured 19Apr2023 and administered on 25-Apr-2023), PRODUCT STORAGE ERROR (The vial was first punctured on 19-Apr-2023 and admnistered on 25-apr-2023 and stored in fridge post puncture.) and NO ADVERSE EVENT (No adverse event) in a 22-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7072B) for COVID-19 prophylaxis.     It was unknown whether patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 25-Apr-2023, 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 25-Apr-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Bivalent Vaccine that was punctured 19Apr2023 and administered on 25-Apr-2023). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was first punctured on 19-Apr-2023 and admnistered on 25-apr-2023 and stored in fridge post puncture.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Bivalent Vaccine that was punctured 19Apr2023 and administered on 25-Apr-2023), PRODUCT STORAGE ERROR (The vial was first punctured on 19-Apr-2023 and admnistered on 25-apr-2023 and stored in fridge post puncture.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (Bivalent Vaccine that was punctured 19Apr2023 and administered on 25-Apr-2023) and PRODUCT STORAGE ERROR (The vial was first punctured on 19-Apr-2023 and admnistered on 25-apr-2023 and stored in fridge post puncture.).    No concomitant medications was reported. It was individual vial, size of the vial was 2.5 ml.  The vial was initially stored in refrigerator on 19-Apr-2023. The vaccine was administered on 25-Apr-2023 at approximately 2.25 pm and 4.19 pm. The vial was stored in fridge post puncture. The vial did not undergone any temperature excursion. Total amount of time the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F) was less than 10 minutes. No treatment drug details was reported. This case contain information of 2nd patient out of 2 patients as described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-721458 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-721458:Patient 1
Patient diagnosed with Covid 2/3/22 and had symptoms of diarrhea, nausea, and shortness of breath.  On 2/15 patient was found confused and hyperventilating.  Patient was admitted to the hospital for hyperglycemia and respiratory failure due to Covid infection.
cellulitis; local swelling, redness, warmth to touch @ inject site; 14FEB92 f/u no addtl event details provided; not indicated if recovered; provided pt details;
I have never experienced neuropathy before with my autoimmune conditions, besides Raynaud's side effect. now I'm experiencing what feels like neuropathy?tingling if skin, and pins and needles feeling, and a bit of brain fog.
swollen left arm; was tired, felt fatigue; I felt weak, unbalanced; sore throat; sneezing; chills; I had trouble walking; I didn't have an appetite; stuffed nose; dizzy; coughing; body discomfort; malaise; his voice changed, it sounds a little lower; his throat is stuffy; he has a cold now but he does not really have a cold; This is a spontaneous report from a contactable consumer or other non hcp.    A 79-years-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 07Mar2021 15:09 (Batch/Lot Number: EN6205) as 2nd dose, single for covid-19 immunisation. Medical history included glaucoma, he is 79 years old and he was diagnosed with that when he was 15, He has high blood pressure and that is under control, he is on one medication for high blood pressure. Caller reported that had a swollen left arm where got the vaccine and then no symptoms on Monday and then yesterday I was shopping and felt like I can't stand up anymore. I was tired, felt fatigue coming on me. I sleep normally and don't get tired in the middle of the day. At 3-4:00 in the afternoon I felt weak, unbalanced, sore throat, sneezing, chills. I still have sore throat now. I had trouble walking. I laid down when I got home and knocked out right away. I didn't have an appetite. I forced myself to eat because I know I have to eat. I had a stuffed nose like a regular head cold , Caller is calling about the Vaccine second dose. He has his card in front of him. He confirms the Pfizer COVID 19 vaccine. He got the vaccine in (city withheld) City on Sunday at about 2:30PM and now it is about 1:30, Monday Tuesday Wednesday. This started on Tuesday afternoon about 24 hours after the vaccine, initially he only felt like his arm was swollen, he didn't have any bodily effect until Tuesday which was about 24 hours later, he started having sore throat, feeling weak, fatigue, dizzy, and coughing and sneezing, general body fatigue. That was all yesterday which was about 24 hours after the shot and today is the third day today he still has a sore throat, fatigue, loss of appetite, body discomfort, dizziness. What he is calling about is he teaches online from his home, so he is normally on a computer but he has this vague feeling of discomfort in terms of concentration and he wants to know when can he expect this feeling to go away. The outcome of the events was unknown on 09Mar2021.  No follow-up attempts are possible. No further information is expected.
Caller received the first & second dose and booster dose of the Pfizer Covid 19 vaccine and got Covid; Caller received the first & second dose and booster dose of the Pfizer Covid 19 vaccine and got Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Caller received the first & second dose and booster dose of the Pfizer Covid 19 vaccine and got Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient received the first and second dose and booster dose of the Pfizer Covid 19 vaccine and got Covid. Then he was prescribed with Paxlovid.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Arm sore; This is a spontaneous report received from a contactable consumer or other non hcp. A 64-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: EN6203) via an unspecified route of administration in Arm Left on 05Mar2021 (age at vaccination 64years old) as single dose for covid-19 immunisation. Medical history included diabetes mellitus from an unknown date and unknown if ongoing Taking metformin maintain normal range, obesity from an unknown date and unknown if ongoing 300 lbs, hypertension from an unknown date and unknown if ongoing maintain normal range with mild medication, arthritis from an unknown date and unknown if ongoing take anti-inflammatory drugs, pain medication as needed. The patient had a historical vaccine of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: EM9809) via an unspecified route of administration in Arm Left on 05Mar2021 14:00 (age at vaccination 64years old) as single dose for covid-19 immunisation. Concomitant medication(s) included paracetamol (TYLENOL); diphenhydramine hydrochloride (BENADRYL) all taken for an unspecified indication, start and stop date were not reported. The patient experienced arm sore on an unspecified date. The clinical outcome of the event was unknown. Therapeutic measures were taken as a result of arm sore.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
4FEB91 developed rash on bottom x 3 days; on 19FEB91 woke up 11PM crying; mom states pt had elevated temp; 21FEB91 to 23FEB91 not checked w/thermometer. 23FEB91 had fine rash from head to toe & itching.
Swollen lips; Welts on back; Hives; This spontaneous case was reported by a non-health professional (subsequently medically confirmed) and describes the occurrence of LIP SWELLING (Swollen lips), RASH (Welts on back) and URTICARIA (Hives) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     No medical history was provided by the reporter. .  Concomitant products included LEVOTHYROXINE for an unknown indication.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced LIP SWELLING (Swollen lips), RASH (Welts on back) and URTICARIA (Hives). On 03-Feb-2021, LIP SWELLING (Swollen lips) and URTICARIA (Hives) had resolved. At the time of the report, RASH (Welts on back) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This spontaneous case was reported by a non-health professional (subsequently medically confirmed) and describes the occurrence of LIP SWELLING (Swollen lips), RASH (Welts on back) and URTICARIA (Hives) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     No medical history was provided by the reporter. .  Concomitant products included LEVOTHYROXINE for an unknown indication.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced LIP SWELLING (Swollen lips), RASH (Welts on back) and URTICARIA (Hives). On 03-Feb-2021, LIP SWELLING (Swollen lips) and URTICARIA (Hives) had resolved. At the time of the report, RASH (Welts on back) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.    No treatment medications provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 01-Feb-2021: No specific follow-up information recorded.   Most recent FOLLOW-UP information incorporated above includes: On 01-Feb-2021: No specific follow-up information recorded.
This spontaneous report was received from a medical assistant refers to a patient of an unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 05-JUL-2016, the patient was vaccinated with improperly stored VARIVAX lot # L043622, expiry date 03-NOV-2017 (dosage not reported) via subcutaneous. No adverse effects were reported. As of 19-JUL-2016, the cumulative/total excursion time: 23 hours and 10 minutes, highest temperature reached 8.2F. No Product Quality Complaint (PQC) was involved. This is one of several cases received from the same source. Additional information has been requested.
Report 2001013626-1 describes therapeutic lack of effect in a pt of unspecified gender and age who rec'd hepatitis B vaccine (Engerix-B). The rec'd dialysis. Allergies and concomitant medications were not specified. Prior to coming to the dialysis facility 2 yrs ago, the pt rec'd a series of Engerix-B on unspecified dates. The pt's titer is "0". As of 6/5/01, the outcome of the event is unknown.
This spontaneous report as received from a registered nurse refers to an unspecified number of unspecified patients of unknown age. On an unspecified dates, the patients were received ROTATEQ (dose/frequency and lot# were unknown), which had been stored improperly. No adverse effect reported. This is one of several reports received from same source. Additional information has been requested.
About 24 hours after receiving vaccine, I experienced extreme breast tenderness in both breasts. They felt sore to the touch all over, had the sensation of being full and heavy, and had to be supported in a bra in order to be tolerable. I liken it to postpartum pain associated with breast feeding and milk engorgement. I would list the symptoms the first night as moderate to severe. It limited my ability to do certain tasks because of the pain and discomfort. The breast tenderness has decreased in severity since then but it is now 1/11/2021 and both breasts are still tender. The severity is now mild. It's uncomfortable but does not limit my daily activity. Of note, I have had a tubal ligation and ablation and am not pregnant but I cannot track the timing of my cycle to know if the vaccine affected my cycle or caused hormonal changes that could explain the breast sensitivity.   I had arm soreness at the injection site for the first 48 hours but that has gone away. No other symptoms to report.