chrisvoncsefalvay/vaers-outcomes huggingface dataset:
drenching sweating; body ache; heartrate was racing/bmps of 122, 123, 137, and 174 (all during sleep); husband almost took her to the emergency room due to her erratic breathing that woke him up; slightly chilly/ severe chills; had a very mild headache; developed a fever (>102); This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot Number: ER8727) via an unspecified route of administration, administered in left arm on 22Mar2021 at 12:45 (at 51 years old) as single dose for COVID-19 immunization. There were no other vaccinations within 4 weeks prior to the first dose of BNT162B2. Medical history included atrial fibrillation (AFIB) (secondary complication during COVID infection) and mild asthma (did not require treatment). Concomitant medications included apixaban (ELIQUIS) and metoprolol both at 50mg 2x/day from unspecified date for unspecified indication. The patient previously took omeprazole and experienced itching without rash. Prior to vaccination the patient was diagnosed with COVID-19 on 26Nov2020. The patient was not tested for COVID post vaccination. The patient received the first dose of the vaccine on 22Mar2021 and the following morning, she felt slightly chilly and had a very mild headache. Just over 24 hours after the first dose, she developed a fever (>102) and severe chills and drenching sweating, headache, and body ache. Additionally, her heartrate was racing, and her smart watch alerted her of this during her sleep. It recorded bmps of 122, 123, 137, and 174 (all during sleep). The patient also reported that her husband almost took her to the emergency room due to her erratic breathing that woke him up. Outcome of the events was unknown.
Patient called 1 week after flu shot administration to complain of diarrhea side effect.
8 days after both vaccines, I broke out in hives/rash.  Vaccine 1 was mild and mostly on my chest, treated easily by benedryl and lasted about 1 week.  Vaccine 2 is more severe.  Hives from my neck down to my feet...heavily concentrated on my torso.  Benedryl gives only minor relief from the intense itching.  Went to an urgent care today (4/12/21) and I am now being treated with prescription Singulair, otc Zyrtec and Pepcid.
Raised, flat red lesions up to size of 25 cent piece. Mostly on face. Pruritic took ZYRTEC at 6:30 AM 2/28/11. Partially resolving by 1pm 2/28/11.
received an expired MMRII; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent condition, drug reactions/allergies and concomitant medication were not provided.   On 03-DEC-2020, the patient was vaccinated with expired measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) 0.5 ml (dose, route of administration and anatomical site of vaccination were not reported, lot #R028225, expiration date reported and validated as 02-OCT-2020) for prophylaxis (expired product administered). The outcome of expired product administered was unknown.
Constant tinnitus ever since the second dose of vaccine. High pitch ringing sound in both ears that will not go away. While it isn't too loud, I always hear it in silence and it is very difficult to go to sleep. It hasn't gone away for a week straight and is starting to worry me that it won't go away.
2 days after vaccine, skin was warm, swollen and red around vaccine site. Also "knot" under vaccine site. Painful for 2 days.
pain increase in the shoulder with loss in mobility; hip tightness got worse where he could barely walk; hip tightness got worse where he could barely walk; Right shoulder pain; Polymyalgia rheumatica (PMR); This spontaneous case was reported by a physician and describes the occurrence of POLYMYALGIA RHEUMATICA in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Tendinitis (patient done surgery for the same).    On 11-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, the patient experienced POLYMYALGIA RHEUMATICA (seriousness criterion medically significant). On an unknown date, the patient experienced MOBILITY DECREASED (pain increase in the shoulder with loss in mobility), MUSCULOSKELETAL DISCOMFORT (hip tightness got worse where he could barely walk), GAIT DISTURBANCE (hip tightness got worse where he could barely walk), and ARTHRALGIA (Right shoulder). The patient was treated with CORTISONE for Adverse drug reaction, at an unspecified dose and frequency and DEXAMETHASONE for Adverse event, at a dose of 6 milligram. At the time of the report, POLYMYALGIA RHEUMATICA, MOBILITY DECREASED (pain increase in the shoulder with loss in mobility), MUSCULOSKELETAL DISCOMFORT (hip tightness got worse where he could barely walk), GAIT DISTURBANCE (hip tightness got worse where he could barely walk), and ARTHRALGIA (Right shoulder pain) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   There was no concomitant medication reported.  This case concerns a 65-year-old, male patient with a relevant medical history of tendonitis, who experienced the unexpected serious events of polymyalgia rheumatica; unexpected non-serious events of mobility decreased, musculoskeleteal discomfort, and gait disturbance, expected non-serious event of arthralgia. The events developed approximately 2 months after receiving the second dose of Moderna mRNA-1273 vaccine. The re-challenge is not applicable as the events reported only occurred after the second dose. The reporter did not provide the causality assessment. The medical history, of tendonitis remains a confounder for the events. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2021-330778 (Patient Link).
Initial report received from a health professional on 04 November 2010. A 63-year-old female patient, with a medical history of hypertension, diabetes, coronary artery disease (CAD), and hyperlipidemia, received on 22 October 2010 an injection (route and site not reported) of FLUZONE, lot number UH183AA. The patient had an allergy to penicillin, DEMEROL and "sumasin". The patient's concomitant medication was warfarin. On 03 November 2010, the patient had an increased INR with her blood work was drawn. The outcome was reported as unknown. Documents held by sender: None.
Patient came back after 16 days on 10/6/10 and complained about having bruise on left arm just above the elbow away from the injection site. He thought it might be because of vaccine he has taken on 9/20/10 and wanted to report. (Reddish, black bruise.)
Got shingles; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, several days after receiving Shingles vaccine, the patient experienced shingles (Verbatim: Got shingles). The outcome of the shingles was not reported.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.   It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 19-DEC-2022 This case was reported by a consumer via interactive digital media. The reporter stated that he/she knew a patient who got the shingles vaccine and then developed shingles shortly thereafter. The follow up would not possible as no contact details were available. The case had been linked to US2022AMR200905, reported by the same reporter, for a different patient.; Sender's Comments:  US-GSK-US2022AMR200905:Same reporter. Patient 2.
+ lightheadedness; + diaphoresis (upon awakening); + feeling faint (her vision started to go black and her hearing diminished before she passed out.). No feeling of warmth.
HPI Pt is a 17yo female, otherwise healthy, who presents with right side of her face with decreased movement, some pain, and eyebrow twitching x 5 hours. Symptoms started out of the blue. No trauma. No hx of similar symptoms in the past. No fevers, upper respiratory infection symptoms, cough, sore throat, nausea, vomiting, diarrhea, rash, dysuria. Does have a blister on her lip x 2-3 days. No weakness to her muscles. No slurred speech. No headache, dizziness, vision changes. She is having trouble blinking her right eye and closing her right eye. Normal oral intake, urine output and activity level. No sick contacts. No known COVID exposures. Got the Pfizer vaccine #1 on 4/27/21.
Arm soreness. A little nauseated. Loss of appetite. Bitter taste in back of mouth. All foods taste bitter except sweets.
She received her 1st dose back in January on 20JAN2021; Chaffing on my fingertips (1st, 2nd and 3rd fingers of each hand); itchiness all over my body; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (She received her 1st dose back in January on 20JAN2021), SKIN FISSURES (Chaffing on my fingertips (1st, 2nd and 3rd fingers of each hand)) and PRURITUS (itchiness all over my body) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027C21A) for COVID-19 vaccination.     No medical history was provided.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Jun-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (She received her 1st dose back in January on 20JAN2021). 09-Jun-2021, the patient experienced SKIN FISSURES (Chaffing on my fingertips (1st, 2nd and 3rd fingers of each hand)) and PRURITUS (itchiness all over my body). On 09-Jun-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (She received her 1st dose back in January on 20JAN2021) had resolved. On 10-Jun-2021, PRURITUS (itchiness all over my body) had resolved. At the time of the report, SKIN FISSURES (Chaffing on my fingertips (1st, 2nd and 3rd fingers of each hand)) had not resolved.            Concomitant product use was not reported.   It was reported  that the patient took an anti-histamine for treatment (not further specified) and the itching improved however, the chaffing is continuing. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular)  was not applicable.
fever; fatigue; body ache; chills; headache; This is a spontaneous report received from a contactable consumer, the patient. A 27-year-old non pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8727) via an unspecified route of administration in left arm on 22Mar2021 at 17:30 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroid and COVID-19. The patient received thyroid medication and birth control within two weeks of vaccination. The patient did not have allergies to medications, food or other products. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 23Mar2021 at 12:30, the patient had experienced chills, headache, body ache, and fatigue. On 24Mar2021 at 01:00, the patient experienced fever, body aches, headache and was tossing and turning. Therapeutic measures were taken as a result of events and included Ibuprofen and patient went back to sleep around 04:00. Adverse events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events chills, headache, body ache, fever and fatigue was resolving at the time of report.  No follow-up attempts are needed. No further information is expected.
Starting the day after I got flu like symptoms. Headache, night sweats, chills. Starting last night, after sweating an obscene amount, I started feeling dizziness. Not a normal dizziness, but a severe one with brain zaps. The type of brain zaps someone has when coming on or off affexor/venlafaxine (which I?m currently on). The dizziness only happens when I stand and the brain zaps happen more frequently than when the dose changes or is forgotten with the snri. Before someone asks... yes... I?m taking my affexor properly and haven?t changed how I?m taking it since my covid shot.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2021 at 9:29 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 11-Jan-2021 at 9:29 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 27.92. . Concomitant products were not provided.  On 11-Jan-2021, Excursion time were 9 AM and 2 PM, temperature were 34 and 35 respectively, total doses given for the day was 98, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 05-Jan-2021 and 08-Jan-2021, vial was moved to clinic on 08-Jan-2021 and 11-Jan-2021. 2 and 9 vials were sent to clinic. Vaccine BUD date was 04-Feb-2021 and 07-Feb-2021.  On 11-Jan-2021, vials were stored in cooler 1, at following time and temperature respectively, 9 AM: 34, 10 AM: 37, 11 AM: 37, 12 AM: 35, 1PM: 36, 2 PM: 37 and 3 PM: 37.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a brand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
Patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021; Patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Mar-2021 at 12:07 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 28-Mar-2021 at 12:07 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 33.75.  Concomitant products were not provided.  On 23-Mar-2021, the vaccine with batch number 019B21A was moved to fridge. On 27-Mar-2021, 20 vials were moved to the clinic. On 28-mar-2021 at 10 AM, vials underwent temperature excursion with temperature of 35 degrees Fahrenheit.  The condition of vaccine prior to vaccination was not frozen. The vaccine beyond use date was reported as 22-Apr-2021.   It was reported that, the storage condition at the time of the excursion was cooler storage during high-pace COVID-19 vaccination clinic.   The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a Fisherbrand traceable temperature monitor at every hour.  It was reported that, the patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021. The health care professional explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34- or 35-degree Fahrenheit.  Treatment medications were not reported.   This case was linked to MOD-2022-566976 (Patient Link).
High fever over 101.5, chills with significant body shaking, headache, muscle pain
Initial case received from a healthcare professional on 16 December 2010. A 79-year-old male patient received FLUZONE HIGH-DOSE (lot number U3612AA) on 01 October 2010. On 11 October 2010, 10 days post-vaccination, the patient notified his physician that he was experiencing pain all over his body, swollen ankles, and high blood pressure. He was seen by his physician, who confirmed that the symptoms had not been present prior to vaccination. No additional information was reported. Documents held by sender: None.
The worst part is my body's itching everywhere.; The first night is not too bad. However, the next day is pretty severe.; Body aching; fever; headache; This is a spontaneous report from a contactable consumer (patient). A 58-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH, COVID-19 vaccine, formulation: solution for injection) via an unspecified route of administration, administered in Arm Left on 16Apr2021 at 16:45 (58-year-old at the time of vaccination) as dose 1, single for covid-19 immunization. Medical history included allergy to shell food like blue crab and urticaria (same symptoms where a lot of hives appeared). The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient was not diagnosed with COVID-19 prior to the vaccination. Since the vaccination, the patient had not been tested for COVID-19. On 17Apr2021, the patient experienced body aching, fever, headache and the worst part was her body's itching everywhere. It was reported that the first night was not too bad, however the next day was pretty severe. Therapeutic measure was taken due to the events included herbal steam hot water & Zyrtec. The patient was recovering from the events.  Information about batch/Lot number has been requested.
Presented with SOB/hypoxia; dx Covid PNA; + covid 4 days PTA; CXR with infiltrates Labs: D-dimer: 0.59; CRP: 6.83;  Tx: Antibiotics (rocephin) Steroids; Remdesivir, Zinc, Lovenox, nebulizers; Initially 100% FiO2 per HF; 12 L by 1/26; back to normal baseline of 6 LPM via NC by discharge
Flu like symptoms, very sore arm, feverish and the next day my arm tingles and has since then.  Feels like it's going to sleep many times per day.
4 days after my 6 year old daughter got her flu shot, she developed a large hive around the injection site. Saturday night she developed hives all over her back and torso. Sunday night again hives developed on her back, torso, legs, and face. We went to the ER, they started her on prednisone and sent us home. She had hives Monday all day but they were not as bad, then Tuesday morning she woke to hives all over her body, the worst it has been. Again we went to the ER and they didn't give us many answers except they believe it's something in the flu shot that she is reacting to, but she does not have an egg allergy. She has been getting BENADRYL around the clock and with the prednisone and her hives are getting worse and this all started when she got her flu shot. There has also been 2 other cases of this happening after getting the flu shot. I have lots of pictures I can email if needed.
Pt left clinic, no reactions reported by patient mother. States that daughter was having c/o pain to site but did not check as she thought that it was normal. Noted this morning that pt had rash to SQ  vaccine area. States arm has active rash with some rased bumps that progressed to upper back.  Plan; pt was instructed to administer Benadryl to patient per provider hand out for dose. If able to come in for an appointment.  Rash is reducing but still pressent. Will continue to monitor.
This spontaneous report as received from a pharmacist refers to a 67 year old female patient with no pertinent medical history and no drug reactions or allergies. On 06-MAY-2015, the patient was vaccinated with a dose of ZOSTAVAX (dose, frequency and anatomical location were not specified, subcutaneously) (lot # K023622, expiration date: 20-FEB-2016) for shingles. Concomitant medication was not reported. On 07-MAY-2015, the patient experienced "a red, raised hard lump at the injection site that was three inches in diameter and warm to the touch". The patient presented to the pharmacist on 08-MAY-2015 also reported as "today" and the pharmacist specifically noted that was not a varicella rash. No treatment was given for adverse event. No laboratory or diagnostic tests were performed. No product quality complaint (PQC) was involved. The outcome of the event was reported as not recovered. The relatedness between the event and ZOSTAVAX was not reported. Additional information has been requested.
Information has been received from a health professional concerning a male who on 08/28/2001 was vaccinated with one dose of varicella vaccine. Concomitant therapy included Prevnar. On an unspecified date, the pt developed a varicella-like rash with papular and vesicular reaction. It was noted that prescription drug treatment was not required. Subsequently, the pt recovered. Additional info has been requested.