chrisvoncsefalvay/vaers-outcomes huggingface dataset:
she experienced swelling around and under her left eye which caused it to "bulge out"; she experienced swelling around and under her left eye which caused it to "bulge out"/the tissue around the outer part of my eye is swollen; sharp pain shooting through her eye; swelling around her eyelid; This is a spontaneous report from a contactable consumer (patient). A 65-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in left arm on 13May2021 (Lot Number: ER8736) at the age of 65 years as single dose for covid-19 immunisation. Medical history included glaucoma, dry eye. Concomitant medications included ongoing brimonidine tartrate, brinzolamide (SIMBRINZA) taken for glaucoma; ongoing polyvinyl alcohol, povidone (REFRESH CLASSIC LUBRICANT EYE DROPS) taken for dry eye. Patient had no other vaccinations within four weeks prior to the first administration date of the suspect vaccine. She had never received a flu shot before. She did not take a flu shot and only took natural herbs. She thought she's having a reaction because she only used homeopathic medications, had a specific diet (listed vegetarian, pescatarian, and organic) and bodies weren't used to chemical medicine. After her first dose she experienced swelling around and under her left eye which caused it to "bulge out". The bulging was most notable in the mornings. She reported her eye doctor said the tissue around the outer part of her eye was swollen and had recommended she see a specialist. Patient experienced swelling around her eye and sharp pain shooting through her eye from 14May2021 and ongoing. She reported that after the first dose, she has had a swelling around her eyelid and around her eye that was not there prior to the vaccine. Her left eye started bulging out a little bit and there was swelling all under her eye. There is swelling in the tissue around her eye. It was not doing any of this before the vaccine. She stated that she was having sharp pain shooting through her eye. She said that it was from her eye brow to the corner of her eye by her nose. She went to see her eye doctor about her eye. The sharp pain in her eye was not as constant as it was previously. Treatments were not received. They checked her retina and glaucoma. Eye doctor thought it was swelling of the tissue around the eye. She was seeing an outer eye doctor on the 15Jul2021. She told them it was because of the vaccine. AEs swelling of eye and shooting pain in her eye require a visit to physician office. Outcome of events were not recovered.
3rd booster shot; shingles rash; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An elderly female patient (not pregnant) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (prev dose product-COVID 19,, prev dose brand-Pfizer,, prev dose brand unknown-False,, prev dose lot unknown-True,, prev dose lot unknown reason-Not, available/provided to reporter at the, time of report completion,, prev dose dose number-2), for COVID-19 immunization; Bnt162b2 (prev dose product-COVID 19,, prev dose brand-Pfizer,, prev dose brand unknown-False,, prev dose lot unknown-True,, prev dose lot unknown reason-Not, available/provided to reporter at the, time of report completion,, prev dose dose number-1), for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "3rd booster shot"; HERPES ZOSTER (non-serious), outcome "recovered", described as "shingles rash". The event "shingles rash" was evaluated at the physician office visit. Therapeutic measures were taken as a result of herpes zoster.  Additional information: It was reported that friend said her mom had some shingles rash after taking the 3rd booster shot. No other vaccine in four weeks. It was unknown if patient taken other medications in two weeks. It was unknown if patient had known allergies. The patient was not tested positive for covid 19 prior to vaccination and had not been tested post vaccination.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Pt felt warm and dizzy. Shared had not eaten all day prior to vaccine. Hx of hypertension and bp was elevated. Observed in clinic and given food / gatorade. Pt recovered without incident and released.
Patient DOB: 11/18/1980. Received his first dose Pfizer (LOT#: EW0179 EXP: 8/2021) at 1108 on 4/27/21. Patient alerted EMT. Patient stated that she was sweating a lot and felt like his vision went blurry/dark for about 3 minutes. Patient stated that he also felt nervous. EMT alerted PHN. PHN suggested to move patient to zero gravity chair. Patient walked with assistance from EMT to gravity chair. Patient walked over and sat down safely on gravity chair. EMT took patients vital signs. BP: 118/60, pulse: 65, O2: 97%. Patient was given water. PHN recommended that patient stay an extra 30 minutes. Patient agreed. EMT re-assessed patient. Patient stated that he was feeling a lot better and that his vision was completely fine now. Patient left vaccination site unassisted and with a steady gait at 1150.
11/22 small red bumpy rash on RLQ abdomen , about 8 small bumps. c/o itchy. 11/23 -bump on neck. 11/24 - more bumps on arm about 3. Rash on belly fading. No meds given.
C/O severe headache, nausea, chills. Minimal relief with Tylenol, Motrin, cold compress. Next day C/O residual headache and pain at injection site.
- patient developed rash over the left leg, where the vaccine was administered. the rash progressed to trunk and right arm.  pupura-violaceous.  differential includes HSP vs hemorrhagic edema of infancy vs serum sickness due to vaccine.  patient also neutropenic transiently.
This spontaneous report was received from a healthcare worker referring to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions/allergies were not reported. On 24-FEB-2016, the patient was vaccinated with a dose of VAQTA (lot # L002717 and expiration date June 2017, unknown route), which was exposed to temperatures outside of the recommended range. There were no concomitant medications provided. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
pt recv vax; devel  fever, was very fussy and did not urinate for 24 hrs;
Within about 4-24 hours the patient noted her arm becoming red, painful and swollen down to her finger tips.  She had difficulty getting dressed due to the pain and edema today.
Vasovagal without loc right arm patchy erythema, urticaria, wheals, numbness and tingling given IM Decadron & Depo-Medrol, PO Clarinex, Hydrocortisone cream
Ringing in the ears constantly still occurring since the  2nd dose..  No history of tinnitus up to this date
Information has been received from a physician assistant concerning a 12 year old female who on 07-JAN-2008 was vaccinated with her third dose of 0.5 ml Gardasil via injection. Concomitant therapy included ROCEPHIN. The physician assistant reports the patient received the third dose of Gardasil and after a couple of hours the patient developed urticaria, anaphylactic reaction, had difficulty breathing, had hives with anxiety and hyperventilating. The physician assistant reported that the mother of the patient wanted to give the patient the third dose of Gardasil and the ROCEPHIN all at the same time before school started, even if the physician assistant wanted to wait to provide the Gardasil. Per the physician assistant, after the patient was given the Gardasil the patient was still fine. The mother of the patient then brought the patient to the dentist on the same day and the patient was given fluoride. The patient went home after the dental appointment and developed the symptoms. The physician assistant noted that the patient was brought back to their office and was given BENADRYL and they called an ambulance to take the patient to the hospital. The patient was brought to the emergency room. The physician assistant was not aware of the present status of the patient and whether the patient was admitted to the hospital. The lot number was not provided and no further information was provided. Additional information has been requested.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Feb-2021 at 1:14 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 28-Feb-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On 28-Feb-2021 at 1:14 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 70.36 for dose administered on 28-Feb-2021. No concomitant medications were reported. Batch number 014M20A underwent temperature excursion on 28-Feb-2021 with temperature 27 degrees Fahrenheit at 09:00 AM and 26 degrees Fahrenheit at 01:00 PM. This vial was moved to fridge on 24-Feb-2021 and beyond use date for the vial was reported as 26-Mar-2021. Product moved to clinic on 27-Feb-2021. Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a traceable temperature monitor at every hour. No treatment medications were reported.
PROGRESS NOTE 2/7/2022 ASSESSMENT/PLAN:  Patient,72 y.o. male PMH of DM2, Anemia, CKD, HTN, who was admitted on 1/28/2022, with shortness of breath 2/2 COVID PNA. Improving but remains on 5 LPM with exertion.     Acute Hypoxic Respiratory Failure 2/2 COVID-19 Pneumonia  Symptom onset 1/20, tested positive 1/21.  Vaccinated x2, not yet boosted. Dexamethesone 6mg x10d -- > Switched to Solumedrol 125 mg IV qd 2/2, started on prolonged 2 week taper from 2/7-2/21.  Supportive cares, antitussives, pulmonary toilet, proning and IS encouraged Did not obtain CT PE study due to renal function, but given improvement in respiratory support, this is less likely. Remains on therapeutic lovenox  No candidate for toci/ baricitinb duration of symptoms>10days   DM2  Hypoglycemic on admission to 40's, but now elevated in the 300's due to steroids.  - continue PTA metformin and glimepiride  - MDSSI, anticipate improvement with tapering of steroids    AKI on CKD stage 3, resolved  Baseline Cr 1-1.2, 1.34 on admission Encouraging PO hydration    Chronic Anemia  2/2 chronic GI bleeding baseline 9-10, at baseline    Mild Hyperkalemia, resolved  - Due to AKI and ACE-I.  HTN - Hold PTA lisinopril, lasix, hydralazine prn  GERD  - Cont PPI HLD  - Cont statin Neuropathy  - PTA  gabapentin  Oral ulcer with Dentures - Add Magic Mouthwash pain improved    CODE STATUS: Full Code  DVT prophylaxis: lovenox GI prophylaxis: PPI
6 days after receiving 2nd dose, sudden hearing loss and tinnitus in Right ear. Severe vertigo 8 days after. Prescribed high dose steroids from doctor, still suffering from hearing loss and tinnitus; 6 days after receiving 2nd dose, sudden hearing loss and tinnitus in Right ear. Severe vertigo 8 days after. Prescribed high dose steroids from doctor, still suffering from hearing loss and tinnitus; 6 days after receiving 2nd dose, sudden hearing loss and tinnitus in Right ear. Severe vertigo 8 days after. Prescribed high dose steroids from doctor, still suffering from hearing loss and tinnitus; This is a spontaneous report from a contactable nurse. A 44-year-old non-pregnant female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN6201) at the age of 44, intramuscularly, administered in the left arm on 15Feb2021 at 15:30 as a single dose for covid-19 immunization. Medical history included covid-19 (If covid prior vaccination: Yes) from an unknown date and unknown if ongoing. Patient has no known allergies.  Concomitant medications included levothyroxine sodium (SYNTHROID); liothyronine sodium (CYTOMEL); and ibuprofen (ADVIL [IBUPROFEN]) all taken for an unspecified indication, start and stop date were not reported. The patient received the first dose of BNT162B2 at the age of 44, given intramuscularly in the left arm on 25Jan2021 at 03:30 PM for Covid-19 immunisation. On 22Feb2021, 6 days after receiving the 2nd dose, patient experienced sudden hearing loss and tinnitus in right ear and severe vertigo 8 days after (24Feb2021). Patient was prescribed high dose steroids from doctor. It was reported that the events resulted in doctor or other healthcare professional office/clinic visit, Disability or permanent damage. The patient was still suffering from hearing loss and tinnitus 3 weeks later. The patient underwent lab tests and procedures which included multiple hearing tests and Magnetic resonance imaging (MRI) both on unknown date with unknown result. The outcome of the event was recovering at the time of the report.; Sender's Comments: Based on known drug profile it  is unlikely that the reported sudden hearing loss, tinnitus and severe vertigo were causally related to bnt162b2.  These are intercurrent  medical conditions.  Case will be reassessed if additional information is received.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
It was reported that a male pt in his 50's received a Fluzone SV '99-'00 vaccination on 11/3/99, at 09:30. Reportedly a few hours, post vax, the pt developed tingling in his left fingers. From additional information received on 12/21/99, it was reported that the pt recovered by the evening of 11/3/99.
Hives all over body. No rash near injection site. Hives on feet, arms, ears, neck, legs, arms
Myalgia, Arthralgia, NauseaVomiting, injection site pain Narrative:
Hardness at the injection site; Big red circle/oval the width of arm, about 3 inches, arm pink/red at injection site; Feeling really tired; Body aching; Chills; Feeling lazy; Arm hurt, arm sore; This spontaneous case was reported by a consumer and describes the occurrence of LAZINESS (Feeling lazy), PAIN IN EXTREMITY (Arm hurt, arm sore), VACCINATION SITE INDURATION (Hardness at the injection site), VACCINATION SITE ERYTHEMA (Big red circle/oval the width of arm, about 3 inches, arm pink/red at injection site) and FATIGUE (Feeling really tired) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for an unknown indication.   On 22-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, the patient experienced PAIN IN EXTREMITY (Arm hurt, arm sore). On 23-Apr-2021, the patient experienced LAZINESS (Feeling lazy), VACCINATION SITE INDURATION (Hardness at the injection site), VACCINATION SITE ERYTHEMA (Big red circle/oval the width of arm, about 3 inches, arm pink/red at injection site), FATIGUE (Feeling really tired), MYALGIA (Body aching) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) on 23-Apr-2021 at an unspecified dose and frequency. On 25-Apr-2021, LAZINESS (Feeling lazy) and FATIGUE (Feeling really tired) had resolved. At the time of the report, PAIN IN EXTREMITY (Arm hurt, arm sore) and CHILLS (Chills) had resolved and VACCINATION SITE INDURATION (Hardness at the injection site), VACCINATION SITE ERYTHEMA (Big red circle/oval the width of arm, about 3 inches, arm pink/red at injection site) and MYALGIA (Body aching) was resolving.            Action taken with mRNA-1273 in response to the events was not Applicable.    This case was linked to MOD-2021-090145, MOD21-082104 (Patient Link).
presented to ED today with chief complaint of cough, shortness of breath, fatigue, loss of appetite, congestion, headache, dizziness, and fever.   Review of Systems  Constitutional: Positive for activity change, appetite change, chills, fatigue and fever. Negative for unexpected weight change.  HENT: Positive for congestion. Negative for ear pain, hearing loss, sinus pressure, sore throat and trouble swallowing.   Eyes: Negative for visual disturbance.  Respiratory: Positive for cough, chest tightness, shortness of breath and wheezing.   Cardiovascular: Negative for chest pain and palpitations.  Gastrointestinal: Negative for abdominal pain, blood in stool, constipation, diarrhea, nausea and vomiting.   COVID 19 pneumonia  - CXR with several nodular opacities within the right lung, interstitial thickening within the left lower lobe.  - urine strep pneumo and legionella negative. Beta glucan was negative. -  Titrate O2 to keep sats 92%-96% - Started on Remdesivir and Dexamethasone 12/28/21. Finished remdesivir on 1/3/21 and dexamethasone on 1/8/21. - albuterol nebs prn, ICS - continue mucinex - Still requiring 2 L of oxygen via nasal cannula but relatively stable.    Discharge Disposition/Condition Disposition: Home Condition: Stable (s/sx potential problems absent or manageable)
This spontaneous report as received from a registered pharmacist refers to a 79 year old female patient. Approximately one week ago, about 28-FEB-2013 the patient was vaccinated with ZOSTAVAX (Dose, route and lot# not reported). It was reported that the patient developed a rash "approximately 2 days ago", on 05-MAR-2013. The outcome of rash was reported as recovering. The pharmacist mentioned ZOSTAVAX was not administered to this patient in her pharmacy. The patient sought unspecified medical attention. Additional information is not expected.
Patient came in on 6/28/17 for her 2nd MMR and told us about her reaction to the first one. She stated the injection site became raised and swollen. 2 days later it was the size of a baseball and raised about one inch. She did not seek treatment at the Dr or ER It lasted about four or five days. She stated she has a latex allergy and we refused to do a second MMR and referred her to her physician for a medical exemption for school.
Dose administered out a vial that experienced excursion for 4 hours; Dose administered out a vial that experienced excursion for 4 hours; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Dose administered out a vial that experienced excursion for 4 hours) and POOR QUALITY PRODUCT ADMINISTERED (Dose administered out a vial that experienced excursion for 4 hours) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001J21-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Dose administered out a vial that experienced excursion for 4 hours). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Dose administered out a vial that experienced excursion for 4 hours). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Dose administered out a vial that experienced excursion for 4 hours) and POOR QUALITY PRODUCT ADMINISTERED (Dose administered out a vial that experienced excursion for 4 hours) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided. Treatment information was not reported.  The vials were returned to stable temperature of refrigerator after 4 hours. The patient received the booster dose.   This case was linked to MOD-2022-525790, MOD-2022-525469 (Patient Link).
Incredible pain in my buttocks down to behind my knee.  I could not sleep on my side or back for 2 days.
Vax given on 3/17/03. This morning noticed soreness with movement/activity.  Observed red, swollen, slightly warm area on lateral, medial upper arm extending to just distal to elbow.  Slightly swollen joint; Denies systemic symptoms.  Exam consistent with above description: redness in excess of 120mm with mild calor and slight induration. Joint with small effusion (elbow) but full ROM and no warmth.  Patient afebrile with normal VS. Treated with 60mg bid allegra for itch/reaction; topical triamcinolone over read area sparing one inch diameter around injection site, and PRN NSAIDs for pain control (very mild); Injection #4 will be delayed until all symptoms have resolved completely and the injection mode will be changed from SQ to IM.  Patient placed on duty restrictions pending resolution and cessation of medications.  Patient will follow up with occupational health to resolution.
Patient awakened at 4am on Monday 11/23/2020 with major reaction; severe hiccups, intense body shivers, severe lower right back pain, muscle and joint pain, leg pain, stomach pain with loose stools, headache, fever at 0415am was 99.3. At 4:30 temp was 100.2. At 5am temp was 101.5. Vomiting event, temp dropped to 99.9, relief of most symptoms. At 5:15 temp went up to 100.3 and the body chills started again. At 5:25, 100.2 temp. 6 am 101.0 temp and same at 6:15am. At 8am 100.3 temp, upon waking. At 0815 100.4, 10:33 am 99.6 temp. Patient still feeling feverish, drove to clinic. No temp at clinic @ 1300. Symptoms had subsided, feeling of exhaustion. Testing done; 4th COVID test, flu test, PSA checked, labs. All lab work 'within  All lab work 'within normal range'. Patient feeling better but upon 11/30/2020 started to have fever at 99. On 12/1/2020 temp was within normal range.  Flu shot done on 09/10/2020 lot #UJ461AA - High dose quad. Administered at same pharmacy, unknown which arm.