chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Spoke with patient around 4:00 pm, 2/15/2023 when patient was at the Consultation window of the pharmacy. Patient reported that she had a reaction to Shingrix vaccination administered on 2/8/2023. Patient reported having upset stomach and vomiting after waking abruptly from sleep. Patient reported redness in the injected arm and itchiness for the next two days after the vaccination. Redness went away and was not present according to patient when she was reporting side effects, but patient still has persistent itching in the injected arm since 2/8/2023. Patient reports using over the counter hydrocortisone cream but has had little success in treatment (2 hours of relief, according to the patient). Recommended patient to see PCP if condition persists and recommended patient to take antihistamine for itching to see if patient is able to obtain relief from condition.
At approximately 5:42pm, the client stated he felt short of breath after last vaccine administered (hep A). The client stood up and took a few steps then stated that he felt dizzy and short of breath. Instructed  client to sit in the chair located in the hallway. The client then became diaphoretic and very pale. Instructed client to put his head between his knees. Blood pressure taken 100/50, pulse 50.  Benadryl 0.5cc IM to RA given at approximately 5:50pm. At a few minutes till 6:00pm, the client stated that he felt better. B/P re-taken 104/82, pulse 68. Client's normal facial color returned and he left the office at 6:00 pm according to his mother. At 7:00 pm, mother was called to follow up on son's condition. Mother stated that he had eaten supper and that he felt just fine. Mother stated that she would "keep an eye on him through the night and that she would let us (office staff / nurses) know if any other problems occurred.
Reporting a reaction to Pfizer COVID 2023-24 vax given at approximately 3:52 PM Monday, 10/16/2023, Lot#HF9298 at Pharmacy Previous COVID vaccinations were also Pfizer. Previous vax was 02/2023 (a different medical facility). I had no long term adverse reaction to that other than an annoying metallic taste which lingered for several weeks. This had also occurred with pervious vaccinations. ?. At 3:59 while waiting 15 minutes after vaccinations I began to get a metallic taste. However, I felt fine and continued to feel fine until late in the evening ?. At approximately 11 PM I suddenly - got an extreme frontal lobe headache (HIGHLY UNUSAL UNDER ANY CIRCUMSTANCES FOR ME), - loud ringing in my ears, -felt cold, -and began to shake violently as though I had no obvious lymph node swelling. -Shortly thereafter, I experienced pain near, but not in several joints, notably where I had had previous injuries. - I drank a lot of water and went to bed with more clothing and covering than typical & slept very fitfully because of pain in the previously mentioned areas and the headache, accompanied by ear ringing. And having to urinate because of the water I'd been drinking. -I basically shook from my bed to the toilet in a repeated cycle. - I got up on Tuesday at approximately 4:30PM feeling better but still having the same symptoms, reduced in intensity. I took 325mg of aspirin and felt substantially better. - a few hours later I began to generate large amounts of mucus. This lessened substantially by Wednesday along the previous symptoms. -As of this writing Thursday late afternoon, my symptoms appear to continue to diminish. I am feeling almost normal, but am still experiencing a slight headache and constant ear ringing.
This spontaneous report was received from a registered nurse regarding patient of an unknown age and gender. The patient's relevant medical history, concurrent condition and concomitant medication were not reported. On 29-SEP-2016, patient was vaccinated with improperly stored GARDASIL 9 injection (lot # M009378, expiration date 23-APR-2018) for prophylaxis (dosage not reported). No adverse effects were reported. No Product Quality Complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information is not expected, as no additional information is available.; Sender's Comments: US-009507513-1612USA008999: US-009507513-1612USA009000: US-009507513-1610USA002776.
This patient received four vaccines on 12/12/00. The patient returned 2 days later with a left arm induration 80 mm length by 100 mm width; the left arm reddened and warm to touch. The patient complained of itching, and slight pain with range of motion. The patient was unable to raise his left arm up fully with out pain. He was referred to the clinic for a doctor to assess.
Systemic allergic reaction; A spontaneous report was received from a Healthcare Professional concerning a 47 years old female patient who received Moderna COVID-19 vaccine (mRNA-1273) and experienced the medically significant event of systemic allergic reaction/ hypersensitivity.  The patient's medical history was not provided. Concomitant product use was not provided.  On 09 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch not provided) intramuscularly for prophylaxis of COVID-19 infection.  On 09 Jan 2021, the patient experienced a systemic allergic reaction and ended up in the emergency room.  On 10 Jan 2021, the patient experienced a new systemic reaction and she was back in emergency room.  The patient was treated with epinephrine.  No relevant laboratory details were included.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event systemic allergic reaction was considered resolved on 10 Jan 2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the events, a causal relationship cannot be excluded.
Not able to sleep; Restless; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Not able to sleep) and RESTLESSNESS (Restless) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-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 INSOMNIA (Not able to sleep) and RESTLESSNESS (Restless). At the time of the report, INSOMNIA (Not able to sleep) and RESTLESSNESS (Restless) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
This spontaneous report was received from an unspecified healthcare professional, referring to multiple unspecified patients of unknown age and gender. Information about patients' medical history, concurrent conditions and concomitant medication were not reported. On unspecified dates, the patients were administered doses of improperly stored GARDASIL that were exposed to a fridge excursion on 21-JUL-2017 (lot # K010215 expiration date 05-MAY-2017, lot# L040459 expiration date 06-APR-2017). This is one of the several reports received from the same reporter. Additional information has been requested.
Local erythema, edema at sites of MMR and Varicella vaccines. MMR - right thigh; varicella - left thigh.
Back and joint pain, especially in (L) upper arm 3 cm red, firm warm area surrounding injection site.
varied from 13 to 18 months since their first dose/ Second dose had not been given; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix (unknown). On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter mentioned that, no patient or vaccine/vaccination information was available.  The reporter also mentioned that, patient information could be retrieved but vaccination data is not available since it was not given at the reporter's location.  The reporter consented to follow up. This case was 1 of the 3 cases, reported by same reported.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021136324:Same reporter US-GLAXOSMITHKLINE-US2021136325:Same reporter
vertigo when lying down, intense, 4/2/21 vertigo when sitting, more mild, 4/5/21 took vitamin c, ibuprofen for treatment  no doctor consulted
SWOLLEN LYMPH NODES ABOVE CLAVICLE ON LEFT; TIREDNESS FOR A FEW DAYS; MILD FEVER; MILD ACHES; This spontaneous report received from a patient concerned a 46 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982, and expiry: 21-SEP-2021) dose was not reported, administered on 20-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 20-JUL-2021, the subject experienced mild aches. On 20-JUL-2021, the subject experienced tiredness for a few days. On 20-JUL-2021, the subject experienced mild fever. On 22-JUL-2021, the subject experienced swollen lymph nodes above clavicle on left. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from mild aches, tiredness for a few days, and mild fever, and had not recovered from swollen lymph nodes above clavicle on left. This report was non-serious.
ERYTHEMA OF EYELID; Eyelid oedema; This non-serious spontaneous case was received during monitoring on 11-APR-2022 with the following Primary ID 2188005-1. The original narrative from the sender is as below:  10 minutes after vaccine administration, physician noticed right eye lid edema and erythema. Patient sent to ED via ambulance for observation.
Approximately 33 hours after receiving my First Covid- 19 Vaccination shot I started to develop a fever, headache, and lower back pain. The fever kept fluctuating from 100 to 101. I drank some water and went to bed early. The next day (today) there is no fever but I am still feeling as if I  am flushed.
Weakness, paleness, nausea, headache, tiredness x 3 days following vaccination on 1/13/10, BP 135/84, P 87-74, O2 Sat 100%.
On 2/13/21 at 4 AM, experienced vertigo/dizziness and a second episode, lasting 2-4 minutes, on 2/22/21 At 5 AM. After the second vaccination (on 3/6), frequent episodes started on 3/17 and every day after that.
pt recv vax & exp titer by latex agglutination;MD reported 9 patients;
Fever; Aches; Tiredness; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Blood pressure" (ongoing). The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, single), for COVID-19 immunization, reaction(s): "Tiredness", "Aches", "Fever"; Bnt162b2 (Dose 2, single), for COVID-19 immunization, reaction(s): "Tiredness", "Aches", "Fever"; Bnt162b2 (Dose 3 (booster), single), for COVID-19 immunization, reaction(s): "Tiredness", "Aches", "Fever". The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "Fever"; PAIN (non-serious), outcome "unknown", described as "Aches"; FATIGUE (non-serious), outcome "unknown", described as "Tiredness".  Additional information: The patient have not had COVID. She had an original 2 dose regimen of Pfizer vaccine and then 2 Pfizer boosters. Aside from general reactions (fever, aches, tiredness), she had no other symptoms. At the end of Sep, she received the Moderna bivalent booster. Seven days later, her symptoms started. She began having severe visual auras, sight disturbances and dizziness. After consultation with her primary care provider, she had a thorough exam from her ophthalmologist who indicated that there were no changes to her eyes. Her doctor then ordered an MRI of her brain. Unfortunately, it was not scheduled until early Dec. She was surprised to learn that she had several subacute ischemic strokes, probably in mid Oct or early Nov. Prior to this, she had no symptoms. She was on the lowest dose of an ace inhibitor which had managed her blood pressure for the last 3 years. Her primary care doctor ordered several additional MRI tests, multiple ultrasounds, a heart monitor, EKG, and echocardiogram. All results indicated that she was healthy. At this point, she saw that Pfizer was found to have an increased stroke risk for adults over 65, Since she had kept a diary of her symptoms, she went back and realized that all her symptoms were the most intense in the 3 weeks following her Moderna booster. Since they had ruled out almost everything else, she wanted to report her adverse event in the hope that it would further their research.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Sender's Comments: Linked Report(s): PFIZER INC-PV202300028832 same patient/event, different vaccine dose number;
feeling foggy/ buzzy/; Dizziness; Chills; Feverish; Achy muscles; flu like symptoms; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), PAIN (Achy muscles), INFLUENZA LIKE ILLNESS (flu like symptoms), FEELING ABNORMAL (feeling foggy/ buzzy/) and DIZZINESS (Dizziness) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Iron deficiency (Borderline iron deficiency), Anemia since 2017 and Hypothyroidism. Concomitant products included FISH OIL, CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) and IRON EXTRA for an unknown indication.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 09-Apr-2021, the patient experienced PAIN (Achy muscles), INFLUENZA LIKE ILLNESS (flu like symptoms), CHILLS (Chills) and PYREXIA (Feverish). On 14-Apr-2021, the patient experienced FEELING ABNORMAL (feeling foggy/ buzzy/) and DIZZINESS (Dizziness). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Sore arm), PAIN (Achy muscles), INFLUENZA LIKE ILLNESS (flu like symptoms), FEELING ABNORMAL (feeling foggy/ buzzy/), DIZZINESS (Dizziness), CHILLS (Chills) and PYREXIA (Feverish) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       concomitant medication included Thyroid PX for hypothyroidism , DIMension 3 for estrogen metabolism, Regenemax plus for collagen generator.     This case was linked to US-MODERNATX, INC.-MOD-2021-143633 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 19-May-2021: Patient demographics, medical history, product details, concomitant medication were updated, events outcome was updated to recovered.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-143633:Dose 2
I had a red, itchy rash beneath the vaccination site that appeared 7 days after my vaccination. It went away after about two days, then came back the very next day. I drew a circle around it. Overnight, it got larger but less red. Throughout the course of the day, it was itchy and warm to the touch. Over the next two days, it gradually got smaller and lost the red color and warmth. About two days later, the redness came back slightly and was barely warm. It was no longer itchy. It?s been three days and I have not had any more issues.
The night of the injection the patient had a violent 12 hour reaction to the shingles shot. Dry heaves, teeth chattering chills, headache, body aches, nausea and vomiting. The next day she was very exhausted. She coincidentally had an appointment with Dr., her ophthalmologist, glaucoma specialist on 8/8/2019. Her eye pressures had soared from 10 each to 15 and 24.  Due to the high IOP she was placed on numerous medications. She was seen again on 8/22/2019 by Dr as a followup to her 8/8/19 appointment.
she developed blood clots which are gone now; she also has an autoimmune condition, she has lupus, and it is not getting any better; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (she developed blood clots which are gone now) and SYSTEMIC LUPUS ERYTHEMATOSUS (she also has an autoimmune condition, she has lupus, and it is not getting any better) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In January 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (she developed blood clots which are gone now) (seriousness criterion medically significant) and SYSTEMIC LUPUS ERYTHEMATOSUS (she also has an autoimmune condition, she has lupus, and it is not getting any better) (seriousness criterion medically significant). At the time of the report, THROMBOSIS (she developed blood clots which are gone now) had resolved and SYSTEMIC LUPUS ERYTHEMATOSUS (she also has an autoimmune condition, she has lupus, and it is not getting any better) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   Patient stated that she had the vaccine in January last year and she developed blood clots which were gone now, but she also had an autoimmune condition, she had lupus, and it was not getting any better. Patient stated that she never got health problems like these before taking the vaccines.  Treatment drug information was not provided.  Company comment: This spontaneous case concerns a female patient (age not specified) with relevant medical history of Systemic lupus erythematosus, who experienced the unexpected serious (medically significant) events Thrombosis (AESI) and Systemic lupus erythematosus, on an unspecified date after a dose of mRNA-1273. The patient experienced blood clots and Systemic lupus erythematosus. At the time of report thrombosis had resolved and Systemic lupus erythematosus had not resolved. Medical history of Systemic lupus erythematosus could be a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a female patient (age not specified) with relevant medical history of Systemic lupus erythematosus, who experienced the unexpected serious (medically significant) events Thrombosis (AESI) and Systemic lupus erythematosus, on an unspecified date after a dose of mRNA-1273. The patient experienced blood clots and Systemic lupus erythematosus. At the time of report thrombosis had resolved and Systemic lupus erythematosus had not resolved. Medical history of Systemic lupus erythematosus could be a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Couldn't keep eyes open; Extremely tired.; Had to leave work; This case was reported by a consumer via interactive digital media and described the occurrence of eye tired in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 17th March 2022, the patient received the 1st dose of Shingles vaccine. In March 2022, less than a week after receiving Shingles vaccine, the patient experienced eye tired, tiredness and activities of daily living impaired. On an unknown date, the outcome of the eye tired, tiredness and activities of daily living impaired were unknown.   It was unknown if the reporter considered the eye tired, tiredness and activities of daily living impaired to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient. The age at vaccination was not reported. The patient had his/her Shingles shot day before reporting (yesterday).  The patient had to leave work and he/she could not keep his/her eyes open. The patient was extremely tired. The follow up would not possible as no contact details were available.
Initial report received from an administrator on 23 Dec 2009: This patient was vaccinated with S-OIV FLUVIRIN 0.5 ml, intramuscular, on 17 Dec 2009. 12 hours after vaccination on 17 Dec 2009, the patient experienced pain in the arm, the entire arm also became red, swollen, and warm. The outcome of the events was reported as had not subsided.
Pt had fatigue yesterday and went to sleep. She woke up on the bathroom floor and was unaware of how she arrived there. She called 911. They came and assessed her. She was stable and was no need to be transferred. She is afebrile and her only symptoms is headache. She will continue to monitor and call back if anything changes. I recommended that she go to urgent care.
7am woke complaining of upset stomach and sore arm (normal for vaccine). Began vomiting, continued throughout entire day. Has never had a reaction to a flu vaccine before. Will be taking her to Doctor tomorrow, still vomiting as of 7pm.
Received vaccine on 7/29/21 and next day started feeling cold symptoms. Then the following day (7/31/21), profuse sweating, muscle cramping, confusion, lethargic, nauseous and vomiting. Ambulance was called and was transported to  hospital.  Upon arrival, they noticed that patient was shivering and had blue lips and extremities. Rectal temp was 92 degrees and CO2 levels were low. IVs, Zofran, and warming blankets and fluids were given until levels returned to a normal range. Initial blood testing showed some out of range values but after temp was restored-subsequent bloodwork was normal. Nurse advised me to report this incident since he had just recently received the vaccine and she thought his symptoms were very odd.
fever; chills; tired; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), CHILLS (chills) and FATIGUE (tired) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19. Concomitant products included ESOMEPRAZOLE SODIUM (NEXIUM [ESOMEPRAZOLE SODIUM]) for an unknown indication.   On 15-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 16-May-2021, the patient experienced PYREXIA (fever), CHILLS (chills) and FATIGUE (tired). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) at an unspecified dose and frequency. On 17-May-2021, CHILLS (chills) and FATIGUE (tired) had resolved. At the time of the report, PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-234374 (Patient Link).