chrisvoncsefalvay/vaers-outcomes huggingface dataset:
diagnosed on 10/21/2020 as having shingles of the eye; rash on her left side of her forehead; nerve tingling on the area surrounding the left eye; blisters on the left eye lid / below left eye brow; blisters / and on the left side of the bridge of her nose; This case was reported by a consumer via call center representative and described the occurrence of ophthalmic herpes zoster in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2020-2021 season) for prophylaxis.   On 31st August 2020, the patient received the 1st dose of Shingrix and Influenza vaccine Quadrivalent 2020-2021 season. On 18th October 2020, 48 days after receiving Shingrix and Influenza vaccine Quadrivalent 2020-2021 season, the patient experienced ophthalmic herpes zoster (serious criteria GSK medically significant), rash, tingling, eye disorder and blister. The patient was treated with valaciclovir hydrochloride (Valtrex). On an unknown date, the outcome of the ophthalmic herpes zoster, rash, tingling, eye disorder and blister were not recovered/not resolved.   It was unknown if the reporter considered the ophthalmic herpes zoster, rash, tingling, eye disorder and blister to be related to Shingrix and Influenza vaccine Quadrivalent 2020-2021 season.  Additional details were provided as follows: The reporter stating she never had shingles before. The patient started to have nerve tingling on the area surrounding the left eye and she had rash on her left side of her forehead and she had shingles like blisters on the left eye lid, below left eye brow and on the left side of the bridge of her nose. The patient was diagnosed on 21st October 2020 as having shingles of the eye and was started on 5 day course of Valtrex by a doctor in Urgent care and since it did not resolve, she saw her ophthalmologist and was again given additional 5 day course of Valtrex. The patient stating the shingles had not completely resolved to date.
EMT noticed client, (DOB 7/1/1950), was sitting in post-vaccine waiting area with flushed face within 15 min of receiving the COVID vaccine (Pfizer, lot #EN6202, expiration date 6/30/2021, dose 1). EMT approached client, asked how she was feeling, client reported feeling fine. At 1337 EMT took oxygen saturation 98% and pulse 96. EMT informed PHN of client's condition and possible language barrier. EMT stayed with client as PHN called over client's family member who was waiting outside. Family member used FaceTime to call client's daughter for help with translation.   Per client's daughter, client suffers from anxiety, asthma, hypertension and hyperlipidemia. EMT took vital signs: blood pressure 140/Palpated, respiratory rate 24, oxygen saturation 97%, pulse 96. Client's list of medications: diltiazem, clopidogrel, atorvastatin, Montelukast, albuterol sulfate, incruise Ellipta, flucatisone propionate, vitamin D, famotidine, benzonatate, losartan, gabapentin, duloxetine, prednisone, and  vitamin C. Client's daughter translated and reported that client felt anxious, warm, and had difficulty breathing similar to her asthma flares. PHN noted client's arm was warm to touch, face flushed, anxious movement as noted by repeated touching chest and face, no use of accessory muscles noted.  At 1346, vital signs: oxygen saturation 95%, pulse 92, blood pressure 138/70, respiratory rate 24. At 1350, PHN offered client benadryl, client consented and took 2 capsules of benadryl (50mg dose) orally. At 1352, client moved to chair outside on patio in front of CWS in the shade as offered by PHN, gait steady and assisted by family member.   At 1352, client signaled to family member that she felt better, PHN noted decreased flushing, posture relaxed with arms at sides while sitting in chair outside. At 1402, PHN advised client and family member to have client follow up with PCP within 24hrs or as soon as possible thereafter. At 1413, vital signs: oxygen saturation 96%, pulse, 84, blood pressure 140/90, respiratory rate 16. PHN noted client yawning, no redness noted in face, no longer warm to touch at 1415. At 1427 vital signs: oxygen saturation 97%, pulse 85, blood pressure 140/100, respiratory rate 16; PHN advised to call 911 if adverse reaction occurs.  At 1430, client left, gait steady, with family member to the car. Family member drove.
Approximately 4 to 5 days after shot, hands were swollen each morning, joints were achy and painful.  On the day of the second shot (1 month later) symptoms were still present and were told to the vaccine administrator.  Second shot was given, within 1 to 2 days of the second shot, swelling began in feet, more joints became affected including hips, shoulders, jaw, knees etc.  Waited 1 month after 2nd dose to see primary care doctor due to worsening symptoms.  Bloodwork was performed and a Prednisone taper was prescribed.  Prednisone taper worked, once discontinued symptoms returned and became severe, limiting mobility to the point of not being able to get out of bed.  Bloodwork came back and antibodies that were never present in prior bloodwork were now present and indicated active systemic lupus with low blood compliment levels.  Referred to a Rheumatologist for further lifelong treatment.
Heart palpitations/if she didn't get enough rest or sleep she would get minor heart palpitations; Extreme tiredness for days; Extreme arm swelling at the site of the injection; I got sick again; I have GI issues; I am still not feeling well; Heart palpitations could be due to dehydration, anemic; she got sick from something that she ate and it seems to have done something with her blood vessels, almost like sciatica in her leg and her side; Heart palpitations could be due to dehydration, anemic; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. A 68-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/lot number: FL3181) via an unspecified route of administration on 17Aug2021 (at the age of 68-year-old) as a single dose for COVID-19 immunization. Patient medical history include E. Coli UTI from Jul2021 to Aug2021 and she has so many drug allergies and Mild reaction. She had taken other medications for this. Concomitant medication included ergocalciferol (VIT D [ERGOCALCIFEROL]). On 17Aug2021, patient experienced extreme arm swelling at the site of the injection like a balloon, extreme tiredness fur days for the next 2-3 weeks from 18Aug2021. On 20Aug2021 she suffered heart palpitations when she didn't sleep well the night before. Heart palpitations started on 20Aug2021, could be due to dehydration and anaemia started on an unspecified date in 2021. Last night she got sick again. she have GI issues from 2021 but it was never diagnosed. Terrible night last night. She was sick for two hours, and hour and half. She still not feeling well. She was supposed to get her 2nd dose on 07Sep2021 afternoon but that was exactly 2 weeks to her mammogram and she read that you can't get the vaccine that close to a mammogram so she didn't get it. her allergies she thought this was mild and good, but she doesn't know if she can get this again but worse with the 2nd dose. She also has been having issues and she got sick from something that she ate and it seems to have done something with her blood vessels, almost like sciatica in her leg and her side since 2021. She usually sleeps on her left side and lately she has had to sleep on her right side because she can't sleep on the left side because of the vaccine, and she doesn't know if the vaccine restricts blood vessels or not. The seriousness of events was reported as non-serious by the reporter. The outcome of the event extreme tiredness was resolved on Aug2021 while palpitation on an unspecified date in 2021 and for other events it was unknown.  Follow-up attempts are completed. No further information is expected.
Redness and swelling at injection site, by 4/13/09 fever of 102, sweats and chills, swelling in jaw, swelling in R arm and joints, significant drooling, tenderness & pain in joints, mild to moderate muscle weakness
Per wife Patient is  experiencing  rigors, tremors, vomiting and tachycardia
Fever Chills Narrative:  significant chills (grade 3) - starting 8 hours after vax administration ; fever - 12 hrs after vax administration (spiked at 103.4 (grade 3)). Required 1g APAP (OTC) and 400mg IBU (OTC) to break. Remained low-grade for ~ 24-30 hrs after vaccine ( highest was 101.1) with rotating IBU and APAP throughout that time. Symptoms resolved after 30 hrs.
Hives and redness on same arm as vaccine was administered.  Facial swelling, itching, and hives on neck began shortly thereafter.
Information has been received from a healthcare worker (office manager) referring to unspecified patients of unknown age and gender. In July 2015 (also reported as since 20-JUL-2015), 19 doses of GARDASIL (lot # K010574, expiration date 08-APR-2017), which were exposed to temperatures outside of the recommended range, had been administered to the unspecified patients (strength, route and dose were unknown). No adverse effects had been reported. Additional information has been requested.
Blood pressure dropped significantly within 15 minutes of receiving shot. This reaction occurred with both shots (2nd shot, 2/13/2021, Lot # EL9284).
A feeling of insecurity when walking due to muscle weakness; Today, I woke up with quite annoying dizziness; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (A feeling of insecurity when walking due to muscle weakness) and DIZZINESS (Today, I woke up with quite annoying dizziness) 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 an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-May-2022, the patient experienced MUSCULAR WEAKNESS (A feeling of insecurity when walking due to muscle weakness) and DIZZINESS (Today, I woke up with quite annoying dizziness). At the time of the report, MUSCULAR WEAKNESS (A feeling of insecurity when walking due to muscle weakness) and DIZZINESS (Today, I woke up with quite annoying dizziness) outcome was unknown.     No concomitant medication was reported.   It was reported that five days ago patient received the fourth dose, a booster dose.  The treatment information was not reported.
This spontaneous report was received from a pharmacy student referring to an unspecific number of patients, of unknown age and gender. Medical history, concurrent condition and concomitant therapy were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of PEDVAXHIB (route, frequency, batch/lot number, expiration date were not reported). The vaccine was exposed to temperature of -2.1 C, during 4 hours, 6 cycles. The call was because of data logger. No previous temperature excursions and no adverse effects were reported. There was no Product Quality Complain (PQC). This is one of several reports received from the same reporter. Additional information has been requested.
Received expired vaccine 12 hours post puncture; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired vaccine 12 hours post puncture) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046L21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired vaccine 12 hours post puncture). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received expired vaccine 12 hours post puncture) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported.  The pharmacist was calling to report that two patients in their 30's received expired booster of Moderna. The dose was administered >12 post puncture. The date the vial was initially stored in the refrigerator was 03-Mar-2022. The date and time the vial first punctured was 07-Mar-2022 at 5PM. The date and time of administration of vaccine was on 08-Mar-2022 at 12:45PM and 1:17PM. The vial was stored in room temperature post puncture.   Reportedly, the vial didn't undergo any temperature excursions. The total amount of time the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F) was about 20 hours.  It was also reported that the vial was not exposed to room temperature for more than 24 hours.  No treatment information was provided.   This case was linked to MOD-2022-505347 (Patient Link).
.Same day as vaccine fever up to 101.4 lasted about 3-4 hours. came down after fever  ."hard bump" red on right leg only .normal activity & appetite within 24 hours of vaccines
Information has been received from Baxter (2014BAX023872) on 28-MAY-2014, concerning a currently 34 year old patient. On an unknown date the patient was vaccinated with a dose of HepB vaccine (manufacturer unknown). On an unknown date the patient experienced sore throat, coughing, aching, weakness and shortness of breath. It was unknown if the patient sought medical attention. The outcome of sore throat, coughing, aching, weakness and shortness of breath is unknown. The original reporting source was not provided. Additional information has been requested.
Hives noted starting at site of MMR injection and spreading over body over next 24 hours. Patient happy and playful, no anaphylaxis.
Patient called stating still had arm pain 2 1/2 weeks after administration. Extremely painful for first 2-3 days - pt took OTC naproxen.
Tired, fatigue, muscle aches, headache, brain fog,  no energy,  hard to get out of bed in the morning(worse in the morning). Symptoms started out mild. Thought I was having sinus issues. Symptoms got worse after my second dose of the vaccine.  I have been in touch with my primary provider. Today February 25th I seem a little better.
My body started to shake and have extreme chills. Muscles kept contracting and I felt couldnt catch my breath. Within minutes I was confused and could barely walk. My husband drove me to ER. When I arrived  my Heart rate was 177. They administered medication to bring down heart rate but that did not work enough. Ultimatly they had to shock my heart to bring it back to normal. I was diagnosed with supraventricular tachycardia. I spent the night in the hospital and was released the following morning around 10am.
HAIR LOSS; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient had no known allergies. The patient never had covid previously. On 18-NOV-2020, the patient received covid-19 vaccine ad26.cov2.s (dose number in series: 1) (suspension for injection, route of admin not reported, batch number were not reported) dose was not reported, 1 total administered for prophylactic vaccination. No adverse events were reported following covid-19 vaccine ad26.cov2.s (Dose number in series: 1). On 23-DEC-2021, the patient received covid-19 vaccine ad26.cov2.s (dose number in series: 2) (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total administered to right deltoid for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 05-JAN-2022, the patient noticed having hair loss which started out small just round the hairline and then a couple of days later, became more significant in a line all the way to the front of the hairline. On an unspecified date, the patient had visited the healthcare professional office (Dose number in series: 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from hair loss. This report was non-serious.
Systemic: Chills-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: other-Severe, Systemic: Headache-Severe, Systemic: Nausea-Severe, Systemic: Unable to Sleep-Severe, Systemic: Weakness-Severe
patient began to feel dizzy, and began to shake after immunization.  Attempted to assist patient to more comfortable chair and they went total limp at which point I laid them down on floor and called for assistance. 911 was called and BP kept dropping so epipen was administered. Patient skin was cold to touch reported loss of hearing temporarily. Let paramedics take over when  they arrived. Patient was ambulatory and was cleared by paramedics, then left under his own power after about 20 minutes
1st dose, 102 fever, soreness to the arm,  on 2nd day noticed a rash/hive/bump on my right lower eye. 2nd dose, felt a bit off, driving home a was noticing heartburn feeling in my lungs, started to develop a headache, sound 6pm notice the rash/hive/bump returning  at my lower eye area. Still early to tell what else.  On 1st dose I didn't get the symptoms till late night and the next day and disappeared on the 3rd day late evening.
Rec'd vacc 4:30 p 4/27. Pt went to school 4/28 - was fine then. 4/28 night developed red area, hot to touch, 9x9 cm approx at vacc site. Talked to on call Dr - advised watching, TYLENOL, check temp. 4/29 had temp (unknown how high) so went to ER @ 8 AM. Antibx given. 4/30/09 Temp 101 degrees, 5/1/09 T-101.8, redness improved, (7cm diameter).
Initial information received on 24-Sep-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 15 months old female patient who received 0.5 mL dose of vaccines ACTHIB lot UI903AAA, expiry date: 14-Sep-2019 via subcutaneous route in the left arm on an unknown date. Concomitant vaccinations included FLUARIX via intramuscular route in the left thigh and MMR via subcutaneous route in the left arm not produced by Sanofi Pasteur (dose and expiry date not reported). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was actual medication error due to inappropriate route of vaccination (ACT HIB given SubQ instead of IM). It was unknown whether patient experienced any adverse event after vaccination. 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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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. Documents held by sender: none.
Bell's Palsy; This is a spontaneous report from a contactable other hcp. A 21-year-old male patient received second dose bnt162b2 (COMIRNATY, solution for injection, lot number: unknown), dose 2 via an unspecified route of administration on 25Feb2021 (age at vaccination: 21-year-old) as dose 2, single for covid-19 immunization. The patient medical history and patient's concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (COMIRNATY, solution for injection, Lot Number: unknown), via an unspecified route of administration on unspecified date as a dose 1 single for COVID-19 immunization. On 26Feb2021 (1 day after the vaccination also reported as within 48hours), patient experienced bell's palsy. The outcome was unknown.  The lot number for [BNT162B2], was not provided and will be requested during follow up.
Fever for three days registering from 103.0 to 105.0, Treatment has been Tylenol and Ibuprofen
Noticed injection site sore, swollen about 3CM and raised in center.  By 12/01/2014 it looks like a smallpox vaccination with raised pustular area in center, but margins reduced to about 2cm.  No fever except at site.
Arm got red and swollen; Arm got red and swollen; Feeling very hot; Dizzy; Tired and exhausted; This is a spontaneous report from a contactable consumer (patient). A female patient of unspecified age (Age: 36; Unit: Unknown) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date in Dec2020 at single dose for COVID-19 immunization. The relevant medical history and concomitant medications were not reported. The patient's arm got red and swollen and she experienced feeling very hot, dizzy, tired and exhausted on an unspecified date in Dec2020. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Information has been received from a mother concerning her 20 year old female daughter, with unremarkable medical history and no known drug reactions/allergies, who in July 2007, was vaccinated with the third dose of GARDASIL. Concomitant therapy included hormonal contraceptives (unspecified). The mother reported that her daughter had lab studies done early this year, and her WBC's were low. Her daughter was hospitalized for 4 days with a throat infection due to her low WBC count. The mother is concerned that GARDASIL is related to the low WBC. The physician cannot determine reason for low WBC count. At the time of the report the patient was recovering. Additional information has been requested.  8/1908 and 8/22/08 MR records received including heme/onc consult and some hospital records. Pt initially seen by PCP 6/5/2008 for c/o sinus sx. Tx with abx. Returned 6/9/08 still c/o being sick now with watery diarrhea. Blister like lesion on L upper thigh sent for bx and labs.  Labs showed leukopenia/neutropenia.  Refered to heme/onc. Heme/onc consults beginning 6/16/08 for eval of low white count. Assessment: profound neutropenia with a relative monocytosis suggests likely autoimmune disease or drug reaction. To stop BCP. DX:  Neutropenia/leukopenia. F/U 6/19/08 with 1 cm supraclavicular node noted on PE. Seen 7/01/08 with sore throat, aches and fever. PE (+) for red tonsils. Tx with abx. WBCs and Neutrophils remain low. Tx with Neupogen.   D/C Summary received for DOS 7/2-8/2008 with D/C DX Neutropenia.  Light pharyngitis/early peritonsillar abscess, s/p incision and drainage (sepsis and fever resolved). Pt presented with fever of 102' and worsening pharyngitis. WBCs 2.2 on admission. Tachycardic at 123. (+) lymphadenopathy and exudate on tonsils. Pt had I&D of tonsillar abscess (+) for normal respiratory flora. Tx with IV abx and neupogen. WBCs up to 4.2 by d/c.
Left arm receiving shot aching & painful & began swelling. 2/14/10 7:00AM swelling spreading & redness notice.  Went to Hospital Emergency facility.  Put on IV for fluids and antibiotics plus oral prescription for antibiotics. 2/15 7:30 AM back to Emergency facility for another IV, redness & swelling spreading. 2/16 scheduled for another IV