chrisvoncsefalvay/vaers-outcomes huggingface dataset:
sore shoulder; This is a spontaneous report from a contactable consumer. A 46-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date in Apr2021 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. It was unknown if patient receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications were not reported. On 19Apr2021 at 09:11, the patient experienced sore shoulder. The patient did not receive any treatment for the event. Since the vaccination, it was unknown if the patient had been tested for COVID-19. The clinical outcome of the event shoulder soreness was recovered on an unknown date in 2021.   No follow-up attempts are needed; information about lot/batch number cannot be obtained; no further information is expected.
Day after flu vaccine - red bumps neck, face, swelling around eyes - seen at UC - BENADRYL. Never had eggs.
Dose given from vial opened/punctured on 09/01/2021. Vial not discarded after the recommended 12 hours after puncture. Dose given on 09/08 from previously punctured vial.  Vial kept in refrigerator at appropriate temperature with no temperature excursions. Reported to Moderna.
Rheumatoid arthritis, began as wrist and shoulder pain. Also affected hands, elbows, legs and back. Prescribed Prednisone, Arava, Vicodin, Cortisone shots, and NSAIDS
Patient was vaccinated on 5/18/2023 with vaccine that expired on 5/17/2023.  Patient did not report any adverse events as a result of the vaccination.
I feel sluggish; I feel tired; This spontaneous case was reported by a consumer and describes the occurrence of SLUGGISHNESS (today I feel sluggish) and FATIGUE (today I feel tired) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SLUGGISHNESS (today I feel sluggish) and FATIGUE (today I feel tired). At the time of the report, SLUGGISHNESS (today I feel sluggish) and FATIGUE (today I feel tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Relevant concomitant medications were not provided.  Treatment medication was not provided.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments
nausea; vomiting; chest pain; myocarditis; thrombocytopenia; This is a Literature-spontaneous report 2021, 1-4; entitled Thrombocytopenia following Pfizer and Moderna SARS-CoV-2 vaccination. A 44-year-old woman was hospitalized for nausea, vomiting and chest pain on the day that she received the Pfizer vaccine (BNT162B2) via an unspecified route of administration on an unspecified date (Batch/Lot number unknown) at single dose (at 44-year-old) for COVID-19 immunization. Her laboratory values included a platelet count of 85 x 109/L and a peak troponin level of 4 ng/mL (normal < = 0.04 ng/mL). The patient was diagnosed with myocarditis but did not require treatment for thrombocytopenia. Her platelets were 61 x 109/L on discharge, but subsequent platelet counts were not reported. The outcome of the events was unknown.  No follow-up attempts are needed. Information on Lot/batch number cannot be obtained.; Sender's Comments: The causal association cannot be excluded between the reported events and BNT162B2 vaccine use. 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 AE. 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.
Varivax given 5/13/04. Positive, confirmed varicella 6/7/04.
On 10/20 patient's right arm started feeling itchy and was red with a slight stinging feeling. It was slightly swollen. Over the past 10 days it has improved but still today, 11 days later, her arm has a small knot and is still itching some at the injection site. There is slight redness/swelling remaining (approv 1 inch in diameter).
I am not totally sure if this is a side effect of the vaccine. But, it is unusual. I am experiencing, intermittently a sharp pain on my left outer mid thigh. It happened last night and woke me up and now that I am relaxing for the evening it comes and goes without a warning. It feels like a Nerve as it sends a sort of shock to the system and I actually say "oww" when it happens.
Painful, swollen red patch about 6 inches in diameter on the same arm as the injection, however, about an  inch below the actual injection site. It is hot to the touch, hard and swollen. The redness has continued to spread over the last 12 hours. Painful even when not touching or moving. No itching or other symptoms.
was administered an expired dose of Act-HIB with no reported adverse event; Initial information received on 06-Apr-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an infant male patient who was administered an expired dose of HIB (PRP/T) vaccine [ACT-HIB] with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included diphtheria, tetanus and acellular pertussis vaccine (Daptacel) for Prophylactic vaccination.  On an unknown date, the patient was administered an expired dose of HIB (PRP/T) vaccine [ACT-HIB] powder and solvent for solution for injection (batch/lot number, expiry date, strength, dose and route: not reported) in unknown administration site for prophylactic vaccination (immunization) with no reported adverse event (expired product administered) (latency: 1 day).  Action taken: Not applicable.  At time of reporting, the outcome was Unknown for the event.   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.; Sender's Comments:  01565719:
Patient reported on 11/20/17 to clinic that on 11/8/17 after receiving vaccines she began to feel ill. By 11/10/17 she had a 101 degree fever and increased to 103 over the next 3 days. She reported having a cough, rash with spots on her body, and could not move her joints. She reported taking ibuprofen and fever went down. By 11/18 her spots/rash had almost disappeared and no report of fever. Patient did not see a healthcare provider.
alopecia occurred p/1st dose of vax & became worse w/each dose;hair odor is causing problems @ work;
Left arm swollen/red, sore to touch. Reaction covered entire upper arm. Temp 98.0. No rash noted. Triage. Ped appt. 6/19/03.
a patient who received a dose of PNEUMOVAX23 10 years ago and was recently diagnosed with pneumonia.; This spontaneous report was received from Pharmacist and refers to a currently 75-year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date in Febraury 2012 (reported as 10 years ago), the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (strength, lot #, expiry date, and route of administration were not provided) for prophylaxis.   On an unspecified date also reported as "recently", the patient was diagnosed with pneumonia. It was not mentioned if the patient received treatment for the event. At the time of reporting, the outcome of pneumonia was not known.   The causal relationship between pneumonia and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was unknown.   Upon internal review, pneumonia was determined to be medically significant.
Information has been received from a health professional concerning a 12 year old female with asthma with exertion, and joint pains at times with no illness at the time of being vaccinated. On 29-AUG-2006, the patient was vaccinated with a first dose of Gardasil (lot # 654540/0800F) IM in the right deltoid at 7 PM. On 29-AUG-2006, within 3-5 minutes after the injection (7:03 PM), the patient got light headed, her eyes rolled back into her head, and her face turned a blue/green color. The patient slid to the floor and began convulsing while her whole body tightened up. The patient experienced dizziness and feeling lightheaded which lasted for several weeks. On 08-SEP-2007, she had blood work performed, an electroencephalogram (result not reported), electrocardiogram (result not reported), chest x-ray (result not reported), and urinalysis. On an unspecified date, the patient recovered. Upon internal review, the convulsion was considered to be an Other Important Medical Event. Additional information has been requested.
Patient was vaccinated with Janssen COVID vaccine on 5/10/21. On 9/11/21, patient was admitted to our facility with COVID-19 pneumonia, acute on chronic hypercabic respiratory failure triggered by COVID-19 pneumonia, and acute on chronic exacerbation of diastolic heart failure. As of 9/15/21, patient is still admitted in the med/surg unit.
Patient had Covid 19 vaccine in his right arm 2 days ago, and today he had a red rash on his upper left  arm, which he stated was slightly itchy.
Red rash all over chest, neck, shoulders, back, stomach and slightly on the legs. No itching but hot to touch almost feels like a sunburn. Extreme fatigue only for one day after the 2nd vaccine. The first vaccine I immediately had my lips go numb. Second vaccine I didn?t have the numbness in my lips and didn?t get fatigue, migraine until the next day. The second day is when I developed the rash.
late onset serum sickness appearing rash at 2.5 cm diameter. U shaped rash surrounding but seperate from fading local reaction. (5.0 cm diameter) Onset at 4 days after DTAP
symptons described below started  jan-18-04.. With multiples erythematous blanching lesions that progresively were spreading all over the body . When fully evaluated on jan-20 infant presented generalized blanching, minimal pruritic erythamous lesions all over the body; with target lesions  without evidence of peripheral edema or arthritis.  The rest of physical examination was completely normal.
she has a rash from head to toe; Broke out body wide pityriasis rosea; This is a spontaneous report from a contactable consumer (patient's mother). An 18-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EW0161) via unspecified route of administration on 29Apr2021 (age at vaccination was 18 years) as DOSE 2, SINGLE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient also received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: ER8733) via unspecified route of administration on an unknown date (age at vaccination was 18 years) as DOSE 1, SINGLE for COVID-19 immunisation. It was reported that the patient received her 2nd dose at Pfizer vaccine on 29Apr2021 and about a week ago in May2021, the patient broke out body wide pityriasis rosea. So, she has a rash from head to toe and she has no history of it. I do not know if its related. Reporter stated, I am not reporting this for help. We have been to a pediatrician. I am doing this because I think it might be concern to Pfizer and her doctor said that she saw another case of same age fully vaccinated with the same rash. I thought maybe you all should know about it. I do not even know if its related. I just thought it is in the public interest to let you know that there's been a reaction. The outcome of the events was unknown.    No Follow-up attempts completed. No further information is expected.
This medically confirmed report (initial receipt 29-Mar-2012) concerns a male patient. The patient reports that when in medical school he almost died after receiving an unspecified influenza vaccine (manufacturer unknown). The event outcome was not reported. Reporter's comments: On 29-Mar-2012, the reporter considered events to be serious due to life threatening events and significant disability or incapacity. No further information available.
Fever at 102.5 and rising when took 1000 mg of Tylenol. Chills. Red, swollen, rashy arm
This spontaneous report as received from a pharmacist refers to unspecified number of patients of unknown age and gender. Information about the patients' relevant medical history, co-suspect or concomitant medications was not reported. On unknown dates, the patients were vaccinated with improperly stored PNEUMOVAX 23 (dose, route, lot# and expiration date were not reported). No symptoms were reported. No PQC (product quality complaint) was involved. This is one of two reports received from the same reporter. Additional information has been requested.
Patient described the injection site as getting red and hard. A rash developed around the area.  No complications were reported and resolved on its own.
Extreme Diarrhea for 12 hours.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 18Mar2021 09:00 (Lot number: EN6207) at the age of 66 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIARRHOEA (non-serious), outcome "unknown", described as "Extreme Diarrhea for 12 hours." Additional information: The patient had no known allergies. The patient had not received any other vaccine within 4 weeks prior to Covid-19 vaccine. The patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. No other vaccine in four weeks. Adverse event: dose 1, extreme diarrhea for 12 hours, somewhere between day 5-7. Does 2, extreme vomiting for 12 hours on day 4/5 (adverse event start date: 12Apr2021, 07:00 PM, resolving; Lot number: ER8732, 08Apr2021, 09:00 AM, left arm, dose number: 2). No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
It has been 6 weeks since my 2nd dose of the Moderna vaccine for Covid-19. For the first 3-4 days I had the usual moderate flu-like symptoms:  dizziness, headaches, fatigue, chills, soreness at vaccine siteetc.  Days 5-7 I seemed to gradually improve. On day 8 all of the symptoms returned with greater severity: this time I had a fever, the chills were much more intense, the headaches were excruciating, body and joint aches all over the place--I couldn't sleep or focus on anything cognitively taxing.  Interestingly, my brother, who was vaccinated just after me, also had more severe side effects beginning on day 8 post 2nd dose. He improved after 3-4 days, but my recovery has been much much lengthier. By day 14 I was still feeling very ill, though the fever did subside.  Sometime in the third week the pain in my arm at the vaccination site returned, then became intermittent, and still bothers me from time to time. I also started getting muscle spasms in the same exact locations that sent me to the ER after my probably bout with Covid in the spring of 2020. Thankfully these lasted only a week or so, though I began feeling muscle soreness in different parts of my body, ever changing. By the 4th week I was slightly better and down to 4 main symptoms: chills (by far the worst of the symptoms--to the point at which my skin would feel like it was being frostbitten by dry ice every time I changed sweaty clothes), occasional splitting headaches, and muscle soreness that included both the injection site on my arm and other areas.  I had other symptoms as well, fatigue and brain fog, etc, but these were present before the vaccination, though not as severe.
Pt received vaccine to right thigh. Developed localized rash with firm raised center. Tender to touch. Rash started on day 8 post injection.
Three days later, I had some rash in my chest. It would itch when I took a bath. It was nothing to go to hospital with. I had that maybe a week. In July, I had shingles. At first, I thought it was mosquito or spider bites but then it got to be so painful and doctor said they are shingles. Doctor gave me Tramadol (and said I would need a shingles vaccination in 6 months) and I ended up in the ER the whole night - was vomiting nonstop and nauseous and I was given some medication to stop the vomiting and. Also at  ER they gave me morphine through the drip. And also gave me the acid reflux medicine. At first they thought I was having a heart attack - they did an EKG and they found that I wasn't having a attack. I dehydrated from vomiting.  They gave me IV fluids. Shingles - I ended up just going to buy Tylenol to drink and doing yoga and sitting down and trying not to stress. I didn't take any medication after that. I am healing and recovering - the wounds are gone but they are still painful if I do anything that triggers them. I'm on the road to recovering.
Chest pain; Elevated BP; Nausea; Headache; Vaccine location=Left leg; 2 heart attacks; Couldn't eat; This is a spontaneous report from a contactable consumer, the patient. A 69-year-old male patient received BNT162B2 (COMIRNATY, Lot EW6175, second dose) solution for injection intramuscular in left thigh on 30Aug2021 at 15:00 (at the age of 69-years-old) as a single dose for COVID-19 immunization. Medical history included AAA (abdominal aortic aneurysm) repair and had several stents. Concomitant medications were not reported. Historical vaccine included BNT162B2 (first dose, lot EW0182) for Covid-19 immunization on 30Jul2021 and experienced increase joint pain, tired, weak and no energy. On 30Aug2021, the patient experienced chest pain, elevated BP (blood pressure), nausea, and headache. In 2021, the patient experienced 2 heart attacks and couldn't eat. Treatment for events chest pain included nitro and elevated BP medication.  The outcome of the events chest pain, elevated BP, nausea, and headache was recovered on 18Sep2021. The outcome of the events heart attacks and couldn't eat was unknown.
The vial administered was first punctured more than 12 hours ago; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The vial administered was first punctured more than 12 hours ago) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-May-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (The vial administered was first punctured more than 12 hours ago). On 21-May-2021, EXPIRED PRODUCT ADMINISTERED (The vial administered was first punctured more than 12 hours ago) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
Headaches and Fatigue after 1st dose Sore throat, Chills, Fever after 2nd dose continued headaches
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Feb2021 at 12:00 as dose 1, single (Lot number: En6202), in left arm, on 15Mar2021 at 13:00 as dose 2, single (Lot number: En6207), in left arm and on 26Dec2021 at 11:00 as dose 3 (booster), single (Lot number: F00809) at the age of 31 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Thyroid cancer" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXIN; ZYRTEC [CETIRIZINE HYDROCHLORIDE]. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (21Jun2022) Negative; (22Jun2022) Positive, notes: took two home tests, both positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Additional Information: The patient was an adult. Patient received other medications in 2 weeks. Patient received treatment for Covid-19 with Paxlovid from 13Jun2022 to 17Jun2022. Adverse event: Last dose of Paxlovid taken Saturday 18Jun2022. Tested negative and felt better on Tuesday 21Jun2022. Woke up congested and achy, with stomach issues, on Wednesday 22Jun2022, took two home tests, both positive and one at urgent care. The events were started on 21Jun2022 at 06:00 AM; the patient not received treatment and outcome of the event was not recovered.
body ache; 101 Fever; gland swelling; headache; fatigue; nausea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 22Aug2021 10:15 (Lot number: FC3183) at the age of 38 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, single, Time(24hr): 20:00, Anatomical Site of injection: Left Arm, Route of administration: Intramuscular, Batch/Lot number: EL1284), administration date: 11Jan2021, when the patient was 39 years old, for covid 19 immunization; Bnt162b2 (Dose 2, single, Time(24hr): 08:30, Anatomical Site of injection: Left Arm, Route of administration: Intramuscular, Batch/Lot number: EL8982), administration date: 29Jan2021, when the patient was 39 years old, for covid 19 immunization, reaction(s): "gland swelling", "headache", "body ache", "fatigue", "nausea". The following information was reported: PAIN (non-serious) with onset Aug2021, outcome "unknown", described as "body ache"; PYREXIA (non-serious) with onset Aug2021, outcome "recovered", described as "101 Fever"; LYMPHADENOPATHY (non-serious) with onset Aug2021, outcome "unknown", described as "gland swelling"; HEADACHE (non-serious) with onset Aug2021, outcome "unknown", described as "headache"; FATIGUE (non-serious) with onset Aug2021, outcome "unknown", described as "fatigue"; NAUSEA (non-serious) with onset Aug2021, outcome "unknown", described as "nausea". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Booster dose due to high risk of frequent institutional or occupational exposure to coronavirus (and at risk of serious COVID-19 complications). Gland swelling for a further week. Also occurred following boosters with 101 fever for 24hrs onset 4hrs after injection.  Follow-Up (28Jan2022): Follow-up attempts are completed. No further information is expected.