chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt is a 57 year old white female who presents to the smallpox vaccination follow up dressing clinic status post vaccinia vaccine times six days. She states that, the day following her vaccination, she began to suffer from increasing body aches, fatigue, general malaise, and fever that maxed at 102.6. She complains of nausea without vomiting and inability to eat or drink since that time. She does complain of increasing shortness of breath and productive cough, which is productive in nature with a green sputum. She denies chest pain. She denies ? related complications other than mild itching/pruritis. She denies generalized rash or rash on other parts of her body. She does complain of orthostatic dizziness. She has only taken Tylenol with small sips of water for the preceding five days. Impression: acute exacerbation of chronic obstructive pulmonary disease, dehydration, rule out vaccinia reaction. Follow up letter states: The latest that I was able to gather from - working on AE's is the following: 57 yof nurse vaccinated 02/27/2003, seen in ER 03/04/2003 for nausea without vomiting, dizziness, shortness of breath. There was no evidence of rash, or fever and no report of diarrhea. Vital signs: 113/80, pulse 100, RR20, PE: Bilateral wheezing, scattered ronchi, no murmur, and normal heart sounds. The pt had a history of HTN, osteoporosis and TIA, no report of COPD. Was on antihypertensives and treatment for osteoporosis. This information comes from the report from the ER, it claims that she was going to be transferred but it is unclear if she was "admitted" or not (it appears to be an overnight ER admission, but this needs to be clarified). They had a requested CXR,ABG's and were going to treat her as an "acute exacerbation of COPD" with antibiotics, bronchodilators, expectorants, and oxygen. COPD is not determined in past medical history from ER however the pt is a smoker since age 14 (1 ppd x 43 ys).  On March 16 while with husband the pt collapsed and was down for 15-20 minutes. EMT's came, pt was resuscitated in. The autopsy report states arteriosclerotic cardio-vascular disease.
Left arm pain; Tiredness; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included breast cancer. Previously administered products included chemotherapy (about 18 years ago). Concurrent medical conditions included hashimoto's disease.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced pain in arm and tiredness. On an unknown date, the outcome of the pain in arm and tiredness were recovered/resolved.   It was unknown if the reporter considered the pain in arm and tiredness to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received the first dose of the Shignrix vaccine in the left arm (date unknown) she had some tiredness and left arm pain which resolved. For the tolerance of 2nd dose refer case; Sender's Comments:  US-GLAXOSMITHKLINE-US2020228597:same reporter US-GLAXOSMITHKLINE-US2020228595:same reporter
Patient experienced tingling in fingers and shakiness approximately 10-15 minutes after administration of vaccine dose. Pt was located in monitoring area when adverse event occurred. She was instructed to remain seated and calm while staff also waited at patient's side. Benadryl 25mg x1 was administered orally per instructions from daughter/ emergency contact. Paramedics arrived 30 minutes into event to further monitor vitals and cleared patient to leave.
Headache, stomach ache, nausea, gave 50 of liquid BENADRYL and observed and monitored vital signs for one hour.Then they felt better and she went home with her dad.
Received flu vaccine on 10/18/23 and on 10/19/23 developed a red, blotchy, non-elevated, mildly itchy rash on chest and neck, also experiencing mild itchiness to scalp and eyes; continues on 10/20/23 non-changed; has not taken any medications.
Back of Tongue tingly and itchy; Back of Tongue tingly and itchy; This is a spontaneous report from a contactable consumer or other non health care professional (patient). A 37-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EN6206, Expiration date not reported), via an unspecified route of administration in arm left on 09Mar2021 09:00 (at the age of 37-year-old) as single dose for COVID-19 immunisation. The patient medical history was not reported. patient had no known allergies. Patient did not had covid prior to vaccination. Concomitant medications included levothyroxine sodium (SYNTHROID) 0.25 mcg taken for an unspecified indication, start and stop date were not reported and was taken within 2 weeks of vaccine administration. Patient did not receive any other vaccinations with in 4weeks prior to vaccination. Patient was not tested for covid post vaccination. On 10Mar2021 12:00 the patient experienced back of tongue tingly and itchy the day after vaccination on and off for 2 days. The patient did not receive any treatment for the event. The outcome of back of tongue tingly and itchy was resolved on an unspecified date in 2021.  No follow-up attempts are possible. No further information is expected.
Immediately after getting the vaccine my left arm was sore, which became worse in the evening, causing me pain to raise my left arm. Around 5 pm the same day, I started having body aches and had the chills. Then around 8pm I spiked a fever which reached up to 102.0 Fahrenheit, which I treated with Tylenol.  In the morning (1/9/2021) the fever returned at 101.2 Fahrenheit, which I treated with Tylenol again.
Unspecified acute conjunctivitis bilateral; This spontaneous case was reported by an other health care professional and describes the occurrence of CONJUNCTIVITIS (Unspecified acute conjunctivitis bilateral) in a 20-month-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR9236B) for COVID-19 prophylaxis. No Medical History information was reported. On 26-Aug-2022 at 2:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 05-Oct-2022, the patient experienced CONJUNCTIVITIS (Unspecified acute conjunctivitis bilateral). At the time of the report, CONJUNCTIVITIS (Unspecified acute conjunctivitis bilateral) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Unknown if the patient has ever been diagnosed with or tested positive for COVID-19. Concomitant product use was not provided by the reporter.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-668074 (Linked Report). This case was linked to MOD-2022-668215 (Patient Link).; Sender's Comments: US-MODERNATX, INC.-MOD-2022-668074:Master Case
Pt. presents 10 days after receiving varicella zoster vaccine given at our pharmacy's clinic. She reports ear pain that radiated down into neck and has rash on chest and back of neck up into hairline.
Narrative:  Patient reported "bad reaction" at PCP visit. Symptoms in chart listed as "facial swelling and injection site swelling x 2 weeks".
On 10SEP91 on routine check up, 10 months p/MMR II was given a severe sensorineural hearing loss was observed; rt onl; pt had no c/o referable to the loss;
More than 35 days since got the first dose and still does not have the second; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (More than 35 days since got the first dose and still does not have the second) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Schizoaffective disorder.    In May 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 PRODUCT DOSE OMISSION ISSUE (More than 35 days since got the first dose and still does not have the second). At the time of the report, PRODUCT DOSE OMISSION ISSUE (More than 35 days since got the first dose and still does not have the second) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient had schizoaffective disorder, he had the first dose of the Moderna COVID-19 vaccine in May and did not get the second one in time because he had an episode. The primary doctor said that the should restart the vaccination series. But when he went to get the first dose again they mentioned that he did not need a second dose. No concomitant medications reported. No treatment information was provided.  This case concerns Product dose omission in a 30 year-old male patient with history of schizoaffective disorder.  The patient did not receive the second dose due to the underlying schizoaffective disorder at the time that the second dose was scheduled.  There is no indication that the schizoaffective disorder is worse or different since receiving the first dose of vaccine.; Sender's Comments: This case concerns Product dose omission in a 30 year-old male patient with history of schizoaffective disorder.  The patient did not receive the second dose due to the underlying schizoaffective disorder at the time that the second dose was scheduled.  There is no indication that the schizoaffective disorder is worse or different since receiving the first dose of vaccine.
Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Shakiness-Mild, Systemic: Weakness-Mild
Post vax, the pt developed a rash which has never subsided. It is located on his back, buttocks, and hands. He states that it appears, disappears, then reappears. He also states it is sometimes itchy.
Tinnitus began about 36 hours after vaccination and has not abated for almost a year. I suffer with a high pitched whistle noise 24/7.
patient reports swelling of arm/ redness, vaccine site was aimed too low TRICEPS vs deltoid. Patient is currently taking OTC  NSAID (ibuprofen). Symptom occurred 7/02/21. Patient notes symptoms are improving
chest pain for one day; itchy; painful; "Moderna rash" on the injection arm; red spot the size of less than a hand; WARNING: THE STUDY CONFIGURATION IS MISSING THE STUDY PHASE. PLEASE UPDATE THE STUDY PHASE AND RE-GENERATE THE NARRATIVE AGAIN.    This     The subject received mRNA-1273 (Moderna COVID-19 Vaccine). The report describes a case of CHEST PAIN (chest pain for one day), PRURITUS (itchy), PAIN IN EXTREMITY (painful), VACCINATION SITE RASH ("Moderna rash" on the injection arm) and RASH (red spot the size of less than a hand).     No Medical History information was reported.  On 12-Apr-2021, the patient experienced CHEST PAIN (chest pain for one day), PRURITUS (itchy), PAIN IN EXTREMITY (painful), VACCINATION SITE RASH ("Moderna rash" on the injection arm) and RASH (red spot the size of less than a hand). At the time of the report, CHEST PAIN (chest pain for one day), PRURITUS (itchy), PAIN IN EXTREMITY (painful), VACCINATION SITE RASH ("Moderna rash" on the injection arm) and RASH (red spot the size of less than a hand) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Swollen left axillary lymph nodes. Tender and mildly swollen x6 days begining at day 5 post vaccination.
9:14 pm, 01/18/21-chills all night-cough, chills, muscle pains 6:43 am 01/19.21- right arm is sore i cannot lift it up, temp of 100.4, chills, headaches and muscle pain
A noticeable red rash at the injection site of the left arm, with heat in an 3" radius of injection site. Today, this same injection site is totally red and swollen with more noticeable heat coming from this same 3" radius. I have taken 2 Benadryl capsules yesterday and 1 today.
Moderna Dose 1 2/10/21 (038K20A) Moderna Dose 2 3/10/21 (038A21A) COVID Positive 1/18/22  1/14/22: 84-year-old female with a past medical history of advanced dementia presents after being found to have a left femoral fracture.  Husband at bedside in as per husband patient fell on January 12th; patient followed up with her primary care doctor the following day and x-ray showed the fracture.  Patient's husband does want surgical intervention if necessary and Orthopedics had been contacted.  At baseline patient requires assistance with all ADLs and she is able to ambulate without any assisted devices.  1/19/22: Left femoral neck fracture  XR confirms  Pt in no obvious pain  -Orthopedics, Dr performed left hip arthroplasty 1/15/22  -Pain not requiring narcotic management at this time; will continue to assess throughout the hospital course  -PT evaluation in place; recommends SNF  Dementia  Has multiple medications that need to be reviewed  Pt is baseline nonverbal  -Resumed home meds  Acute blood loss anemia-stable  likely from injury and surgery however is hemodynamically stable  -Monitor  COVID Positive  Pt is asymptomatic and positive test was prior to planned discharge to SNF  -Monitor
This spontaneous report has been received from a Registered Nurse concerning an unspecified number of patients of unknown age and gender. Concurrent conditions and pertinent medical history were not reported. Some doses of RECOMBIVAX HB, (Lot # L007558, exp. date 10-OCT-2016 and Lot # K026666, exp. date 22-OCT-2016), (strength, route of administration and dose were not provided), which were exposed to temperature outside of the recommended range, have been administered to unspecified patients on unspecified dates since 28-AUG-2015. No adverse experience had been improved. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Initial unsolicited report received from consumer on 20-Dec-2017. This case involve patient (age and gender was not reported) who was vaccinated with dose of FLUZONE HD (batch number, expiry date, route and site of administration were not reported) on an unspecified date in Nov 2015. The patient's medical history and concomitant medication were not reported. On an unspecified date in Jan 2016, few weeks post vaccination patient had noticed tingling in feet. Patient was diagnosed with several autoimmune disease Iritis and Crohn's). It was patient's belief that the amount of antigen provided by high dose of FLUZONE jolted patients compromised immune system into high gear resulting in production of anti-mag antibodies. As a result of having anti-mag patients life was extremely disrupted, physical and mental state was deteriorating. Laboratory investigation and corrective treatment were not reported. Outcome of events was not reported. List of documents held by sender: none.
DTaP given on 08/21/2003 4"x5" red, swollen, warm to touch reaction left upper arm (ice, benadryl prn)
6:30 AM woke up with chills, pain in most joints, a mild sore throat, pain level 6/took temp was 101.2 has come down with aspirin and TYLENOL to 99.9, now I had 8 rounds of watery diarrhea/ swelling and hot lump on my deltoid at injection site. I've never have experienced any vaccine reactions before.
During administration of flu shot, device malfunctioned and RPh had to get another needle tip and reinject patient. Upon 2nd injection, pt felt pain at injection site. She has had persistent pain at injection site and down arm since immunization. This pain has been relieved some with steroids. But comes back when steroids are discontinued.
Sore body all over with chills and can't lift injection arm. Took ibuprofen, took hot shower, laid in bed
20MAR96 pt recv vax & 5JAN97  spot where vax given started bleeding;also exp discomfort in shoulder;
After her first dose, caller reports her face becoming numb for two and half days after; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age was received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: not reported) via an unspecified route of administration on an unspecified date in 2021 as DOSE 1, SINGLE for COVID-19 immunisation. Medical history included allergies to shellfish from an unknown date and unknown if ongoing. Concomitant medications were not reported. After her first dose, her face became numb for two and half days after on an unspecified date in 2021. The patient reported that she was scheduled to receive her second dose the next day. After the first one she waited for 30 minutes. Patient was asking about the side effects of the vaccine and if she should get the second dose. She was nervous that the call handler kept repeating her like that. Attempted to clarify what caller meant. She was afraid with the government. She did not want the government coming after saying that she was a snitch or something. Patient was told by call handler that they were unable to tell her whether or not she should get the second vaccine but they suggested she reach out to her primary care provider or health department if she had further questions. Patient stated no, because she already tried with VAERS and she did not want anything nefarious. She would wait for her doctor but they said to ask the allergist but the allergist cannot see her until July. She could not wait that long because she was supposed to her second dose the next day. Outcome of the event was recovered on an unspecified date in 2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Upon receiving my first shot, I felt weak, and after a few days a tingly feeling in my head. Symptoms lasted for 2 weeks. After receiving the second dose, I had a fever that evening and weakness, it lasted through the next day. My right arm was sore for 2 days.  I took Advil, Tylenol, and ibuprofen (at different times). Symptoms of fever lasted two days and were gone, I was left feeling weak, it lasted for a day.  Now day 5 after I got my shot (got the last dose 1/22/2021), I have noticed some vaginal bleeding that has been going on for 2 days now (It's not the menstrual period since I had that going on a week before I got my last shot). I am wondering if there are any other women who have experienced the same reaction to their body. Kindly feel free to call me or email me with any answers. I am trying to reach my primary physician who is currently booked till February.
a couple drops leaked out onto the patient's arm; a couple drops leaked out onto the patient's arm; a couple drops leaked out onto the patient's arm; This case was reported by a nurse via call center representative and described the occurrence of incomplete dose administered in a 53-year-old male patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2021-2022 season) (batch number T93SR, expiry date 30th June 2022) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 9th November 2021, the patient received Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device. On 9th November 2021, unknown after receiving Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced incomplete dose administered, inadvertent exposure to vaccine and exposure via skin contact. On an unknown date, the outcome of the incomplete dose administered, inadvertent exposure to vaccine and exposure via skin contact were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: The Nurse reported that, while she was administering a dose of Fluarix and a couple drops leaked out onto the patient's arm which led to incomplete dose administered, inadvertent exposure to vaccine and exposure via skin contact. The consent to follow up was not asked.
No additional adverse event; patient was inadvertently administered a dose of PROQUAD on 6/16/2020, that had been improperly stored; This spontaneous report was received from a licensed practical nurse, referring to a 12-year-old male patient. The patient's pertinent medical history, concurrent conditions, concomitant medications, drug reactions, or allergies were not reported.  On 16-JUN-2020, the patient was inadvertently vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) injection (vaccination scheme, anatomical location and route of administration were not reported; lot number S030215, which has been verified to be valid, expiration date reported and validated as 25-MAR-2021) as prophylaxis (product storage error). The vaccine was reconstituted with properly stored sterile diluent (DILUENT MRK). No additional adverse event.  The vaccine experienced a temperature excursion of 7.2 degrees Fahrenheit (F) for 30 minutes. There were previous temperature excursions on 05-JUN-2020 with a temperature range of 6F to 14F for 1 hour, and between 15F to 46F for 4 hours; on 08-JUN-2020 with a temperature range of 6F to 14F for 1 hour and 50 minutes; and on 15-JUN-2020 with a temperature range of 6F to 14F for 20 minutes, as recorded by a data logger.
Intense brain fog, dizziness, and nausea. Dizziness lasted about 5hrs. Brain fog began to fade after 20hrs. Nausea persisted for about 30hrs.
Skin darkening near armpit. Looks like lymph vessels are dark as though dye was injected. Under both arms.
Patients wants this documented and placed on file. Red blotch around injection site measuring about 2 inches in diameter. Hot to touch.
Tramatic atrial fibrillation event that required chemical cardio version to correct. Began around 8:30 PM on 8/18/2021 and went back to sinus rhythm at 11 AM on 8/19/2021 after full night hospital stay with many medications for chemical cardio version
Awoke day after vaccine with small bumps near inj. site. 2 days after vaccine developed whole body rash that came and went. No fevers.
had a delayed reaction a week later with full blown anaphylaxis with closure of throat and was treated; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team, Program ID.  A 67-year-old female patient received bnt162b2 (BNT162B2), in 2021 as dose number unknown, 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: ANAPHYLACTIC REACTION (medically significant), outcome "unknown", described as "had a delayed reaction a week later with full blown anaphylaxis with closure of throat and was treated". Therapeutic measures were taken as a result of anaphylactic reaction. Clinical course: Patient was administered with prevnar 20 on unknown date. Physician reported that a patient received the 'original Pfizer Covid 19 vaccine' and had a delayed reaction a week later with full blown anaphylaxis with closure of throat and was treated. The cause was determined to be related to the polyethylene glycol in the Pfizer Covid 19 vaccine. This was when the patient was under the care of another provider. This occurred 2 years ago. Patient wanted to ask about immunization for Prevnar 20. No administration.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: There is a reasonable possibility that the event anaphylactic reaction was related to BNT162b2 based on known drug safety profile and temporal relationship.
Severe stomach pain and weakness.   Very tired and barely able to get out of bed.  Kidney pain.