chrisvoncsefalvay/vaers-outcomes huggingface dataset:
neurological effects/trigeminal nerve; Adverse Events; This spontaneous case was reported by an other health care professional and describes the occurrence of NEUROLOGICAL SYMPTOM (neurological effects/trigeminal nerve) and VACCINATION COMPLICATION (Adverse Events) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NEUROLOGICAL SYMPTOM (neurological effects/trigeminal nerve) and VACCINATION COMPLICATION (Adverse Events). At the time of the report, NEUROLOGICAL SYMPTOM (neurological effects/trigeminal nerve) and VACCINATION COMPLICATION (Adverse Events) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
I had a fever and was tired. I took Tylenol and I slept a lot. It took 24 hours to subside. I contacted the pharmacy regarding what I was experiencing and they only recommended taking Tylenol.
Elevated Blood pressure outside of normal range at 220/110. Have gone to the ER three times due to Chest pain and severe elevated blood pressure. New medications started include Amlodipine, ASA, Rosastatin.
After I got the 2nd dose,  I noticed a ringing in my ears.   I noticed it has been happening since February  2021 so I decided to get it check out.  I did not link it to the vaccine initially, but I spoke to my doctor who also had patients reporting the same symptom after the vaccine. My PCP referred me to an ENT and the ENT sent me to an audiologist and the audiologist sent me to another specialist.  I was advised that there's nothing that can be done except using hearing aids or using a sound machine.  I am suffering from the tinnitus 24/7 and it has not resolved.
Information has been received from a registered nurse concerning a 75 year old female patient with osteoporosis and a history of ovarian cancer who on 11-APR-2007 was vaccinated with Zostavax, subcutaneously. There was no concomitant medication. On 13-APR-2007 the patient experienced cellulitis with redness and swelling at injection site and shingles lesions, located left of midline, in the area of T-12 to L-1. She went to the local ER on 14-APR-2007, and was placed on acyclovir, KEFLEX, and LORTAB, then was released. A follow-up visit with her physician had the patient showing improvement of all symptoms. It was reported that the patient had intervention to prevent serious criteria (other important medical event). There was no product quality complaint involved. Additional information has been requested.
I've had ringing in my left ear within 30-60 minutes after I got the second shot on 4/22/21. I've never had a problem with ringing in my ears and it's been 21 days since I had the shot and the ringing continues and is nonstop throughout the day.
Vaccine given beyound 30 days of refrigeration period; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine given beyound 30 days of refrigeration period) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008021A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine given beyound 30 days of refrigeration period). On 02-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine given beyound 30 days of refrigeration period) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medication information provided. No treatment medication information provided.   This case was linked to MOD-2021-313106 (Patient Link).; Sender's Comments: This case concerns a 29 year old female with no reported history who experienced the non-serious, unlisted event of Expired product administered on the day of the first dose of mRNA-1273. Re-challenge is not applicable. Benefit-risk relationship of mRNA-1273 is not affected by this report.
mom phoned office 31JAN97 to state pt had broken out w/chickenpox;office protocol for varicella reviewed;
elevated blood pressure and cholesterol level's; elevated blood pressure and cholesterol level's; Chills; Headaches; Joint pain; myalgia; fatigue; not feeling well; This is a spontaneous report from a contactable consumer (patient). A 78-years-old male patient received second dose of BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: EJ1686) (age at the time of vaccination was 78 years) via an unspecified route of administration on 11Feb2021 at 02:00 PM in left arm as DOSE 2, SINGLE for COVID-19 immunisation. The patient's medical history included COPD and asthma. Concomitant medications included lisinopril, amlodipine, simvastatin, and aspirin low. The patient received first dose of BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: EN5318) (age at the time of vaccination was 78 years) via an unspecified route of administration on 23Jan2021 at 02:30 AM in left arm as DOSE 1, SINGLE for COVID-19 immunisation. No other vaccine in four weeks. No COVID prior vaccination. Not tested for COVID post vaccination. On 17Feb2021, the patient experienced chills, headaches, joint pain, myalgia, fatigue and elevated blood pressure and cholesterol levels and not feeling well. No treatment was received for the events. AE resulted in Doctor or other healthcare professional office/clinic visit. The outcome of the events was unknown.  Follow-up attempts were completed. No further information was expected.
After receiving the first shot, developed a headache on right side; later that evening had a runny nose; Nausea; Diarrhea; Loss of appetite; Sleep loss; Achy; Overall exhaustion; This is a spontaneous report from a contactable consumer. A 62-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number EN6203, on 03Mar2021 11:00 at single dose in left arm for COVID-19 immunization. Medical history and concomitant medications were none. The patient had no Allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 Prior to vaccination. The patient had not been tested for COVID-19 Since the vaccination. After receiving the first shot, the patient developed a headache on right side on 03Mar2021 11:00, later that evening had a runny nose, nausea, diarrhea, loss of appetite, sleep loss, achy and overall exhaustion.  This lasted for 7 days. Treatment received for headache and achy included Tylenol on day 3. The outcome of all events was resolving.
Injection site soreness; swollen lymph nodes; slight headache/next day headache; nausea; aches; felt like I had the flu; injection site inflammation; This is a spontaneous report received from a contactable consumer (patient). A 69-year-old female patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EN6201) via an unspecified route of administration on 04Mar2021 at 10:00 (at the age of 69-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included allergies to penicillin and sulfa. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. The patient had not been diagnosed with COVID-19 prior to the vaccine. Concomitant medications included levothyroxine, rosuvastatin, and bioidentical hormones from unknown dates for unknown indications. On 05Mar2021, the patient experienced injection site soreness, injection site inflammation, swollen lymph nodes, next day headache, slight headache, nausea, aches, and felt like she had the flu. The patient did not receive any treatment for the events. The patient felt fine the next day on an unspecified date. The outcomes of injection site soreness, injection site inflammation, swollen lymph nodes, next day headache, slight headache, nausea, aches, and felt like she had the flu were recovered. It was also reported the patient had not been tested for COVID-19 since the vaccine. The patient received dose 2 of BNT162B2 (lot number EN6204) on 25Mar2021 as a single dose in the left arm for COVID-19 immunization.  No follow-up attempts are needed. No further information is expected.
This spontaneous report was received from a registered nurse refers to a patient of unknown age who on 21-NOV-2012 was vaccinated with an improperly stored dose of PROQUAD (dose and route unknown), Lot # H015623, Exp date: 21-FEB-2014. No other co-suspects were reported. No concomitant medications were reported. No adverse event reported. Patient's outcome was unknown. This is one of several reports from the same source. Additional information is not expected.
Patient was administered Wrong dose. Patient was given when needed to be administered a Pfizer 12+.
Subsequent to receiving one dose of varicella virus vaccine live on 8/24/95, the pt developed a chickenpox rash with less than 100 lesions and mild itching.
MUCUS; FEVER (FLU LIKE SYMPTOMS SUBSUMED); This spontaneous report received from a consumer concerned a 21 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on MAY-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On MAY-2021, the subject experienced mucus. On MAY-2021, the subject experienced fever (flu like symptoms subsumed). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from mucus, and fever (flu like symptoms subsumed) on MAY-2021. This report was non-serious.
Dime - sized swelling/discoloration immediately after injection at injection site; ice pack applied, patient offered IBPROFEN but declined.
This spontaneous report was received from a physician via company representative, concerning a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 29-JAN-2016, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot number L024129; expiration date 21-JAN-2017) "10 Pk 0.5 ml SD-pFS LLok w tip" (route of administration and anatomical location were not reported). On an unspecified dates, the PNEUMOVAX 23 had one temperature excursion of 240 hours. The highest recorded temperature was 34 F (1.111111111). No adverse effects reported and no product quality complaint was involved. The vaccine status was reported as "in excursion". The vaccine storage criteria and the storage type of excursion were reported as "Refrigerator (R)". This is one of several cases reported from the same reporter. Additional information has been requested.
Angioedema, lower lip swelling, lightheadedness, throat tightness, tingling  lips, tongue, throat and difficulty swallowing.
HOSPITAL COURSE: Patient admitted for acute respiratory failure with hypoxia secondary to COVID pneumonia as well as presumed superimposed bacterial pneumonia. Her was given a 5 day course of remdesivir, prolonged daily course of dexamethasone, as well as azithromycin, ceftriaxone then later doxycycline. He had gradually increasing oxygen demand requiring high flow O2. Family did not wish to pursue any further options of oxygenation/ventilation. Patient has had limited to no oral intake over the last several days due to aspiration and lack of desire to intake food or fluid. Patient gradually declined in level of alertness. Patient expired naturally surrounded by family on July 14, 2022.
Big rash few inches below the injection site that?s itchy.  Throbbing Headache for a few days
Call from immunization clerical staff stating client had left phone message stating that she had blisters at the site of her shingles shot.  Said area was painful.  Client seen by physician today who told her he had never seen anything like this.  He told her to put ice on it and take benadryl.  Client said call was only to report for tracking purposes.  2:30 4/20/09-  Follow up call to client today.  States initially had generalized body aching that then localized to upper back, left side neck and left arm at injection site.  This happened about a week before seeing physician (4/13/09).  Since physician visit, about 5 days after blisters appeared they broke open and are now scabbed.  States there is still redness at blister site and area is sore to touch.  States she has routine appointment with Dr 4/23/09. Client aware I am filing VAERS report.
#1 The 2nd injection was March 6 at noon.  #2 On March 8 at 8:15 AM  I had a sudden burning on my forehead and within one minute this burning covered my body leaving most of the skin area red in color. I also quivered lightly for about 30 minutes. The painful burning and discoloration began fading at two hours and was mostly gone by the third hour. #3 On March 9 at 11:20 AM the same event reoccurred, exactly as the previous day. #4 On March 14 at 8:30 AM I had the third attack, which was similar to the first two. #5 I would not call this a rash. It did not itch. There was a burning, buzzing feeling. I did not touch my skin. I called many phone numbers to see if I should take a Benadryl tablet, but none of the numbers we knew or were given provided any medical expertise. #6 We have photographs on these events.
Information has been received from a registered nurse concerning a 13 year old female who was vaccinated with the third dose of Gardasil (Lot #658222/0927U) on 21-AUG-2007. On approximately 21-AUG-2007, the patient complained of a headache with a short duration after the third dose of Gardasil.  This is one of three reports from the same source/siblings.  Additional information has been requested.
Systemic: Nausea-Mild, Systemic: Eyes tearing (patient did also state she had this for a few days prior as well, just worse after receiving vaccine)
Had flu like symptoms for 1 day 6 hours following the vaccination. My menstrual cycle used to be 28-30 days for 5 years. After my first two doses of the COVID vaccination - my menstrual cycle changed from 28-30 days to 19-22 days. Then after my booster shot on Dec 1, 2021, it change from 19-22 days to 13 days... In addition, my periods are very heavy and painful cramping.
Red raised circle around; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Red raised circle around) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (Red raised circle around). At the time of the report, VACCINATION SITE ERYTHEMA (Red raised circle around) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       For mRNA-1273 (Moderna COVID-19 Vaccine) (unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. Patient reported that she had not taken any medicines to alleviate her symptoms.
Consumer answered yes when asked if they experienced any side effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Consumer answered yes when asked if they experienced any side effects) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Consumer answered yes when asked if they experienced any side effects). At the time of the report, VACCINATION COMPLICATION (Consumer answered yes when asked if they experienced any side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product information was provided.  Treatment information was not provided.
Rebound case after treatment with Paxlovid; COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP).  An elderly male patient received BNT162b2 (BNT162B2), on 24Feb2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Htn" (unspecified if ongoing), notes: Htn; "Hyperlipid" (unspecified if ongoing), notes: Hyperlipid. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment"; DISEASE RECURRENCE (medically significant), outcome "unknown", described as "Rebound case after treatment with Paxlovid". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: It was unknown whether the patient was taking any other medications/products within 2 weeks of starting COVID-19 treatment. Relevant past drug history includes Allergy. Patient previously receive a COVID-19 Vaccine. Rebound case after treatment with Paxlovid. Patient received Paxlovid for treatment of Covid 19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information provide and plausible temporal association, the causality between BNT162B2 and events  (DRUG INEFFECTIVE, COVID-19 )cannot be completely excluded.
Pt stated she had cellulitis in arm and could not work. Stated ER physician told her she would have to wait it out.
7/2/03 child broke out in fine, red rash from head to toe including hair and scalp. Parent reports fever of 103 when awoke this AM. 4PM, patient in health department, MD phoned, appointment made.
temperature excursion on GARDASIL 9; No other adverse events - No signs or symptoms reported; Information has been received from a registered nurse reporting on a patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history or concomitant medication.  On an unknown date, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 0.5 mL for prophylaxis, lot# 1687293 and expiration date reported as 25-AUG-2022, but upon internal validation was established as 30-APR-2023 (route of administration not reported). No adverse events were reported.  On an unknown date, the vaccine underwent a temperature excursion of 47.1 Fahrenheit degree for 13 minutes. No previous temperature excursions were reported. The call was not placed because a digital data logger.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; manufactureraddress: ; manufacturercity: ; manufacturerstate: ; manufacturercountry: ; devicelotnumber: 1687293; expirationdate: 30-APR-2023; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2103USA005285: US-009507513-2104USA003211: US-009507513-2104USA003212: US-009507513-2104USA003213: US-009507513-2104USA003214: US-009507513-2104USA003215: US-009507513-2104USA003216: US-009507513-2104USA003217: US-009507513-2104USA003218: US-009507513-2104USA003219: US-009507513-2104USA003220: US-009507513-2104USA003221: US-009507513-2104USA003222: US-009507513-2104USA003223: US-009507513-2104USA003224: US-009507513-2104USA003225: US-009507513-2104USA003197: US-009507513-2104USA003198: US-009507513-2104USA003199: US-009507513-2104USA003200: US-009507513-2104USA003201: US-009507513-2104USA003202: US-009507513-2104USA003203: US-009507513-2104USA003204: US-009507513-2104USA003205: US-009507513-2104USA003206: US-009507513-2104USA003210: US-009507513-2104USA003207: US-009507513-2104USA003208: US-009507513-2104USA003209:
pt recv vax;devel a rash;pt's MD felt there was no problem w/ the particular lot;f/u stated that pt devel "modified measles" & completely recovered;
Initial misuse report received from a healthcare professional on 22 May 2014. A patient had received 0.5 ml second dose of FLUZONE on an unspecified date. It was reported that the patient was administered 0.5 ml for the second dose in flu vaccine series instead of age appropriate dose of 0.25 ml. No adverse event was reported. List of documents held by sender: none.
Pt was given high dose Fluzone per her request instead of regular dose fluzone due to immunocompromising conditions
patient inadvertently received a third dose of Shingrix; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 62-year-old male patient who received Herpes zoster (Shingrix) (batch number 3N743, expiry date 20-AUG-2024) for prophylaxis.   Previously administered products included Shingrix (on 30th October 2020 received 1st dose.) and Shingrix (on 31th December 2020 received 2nd dose.).   On 13-JUL-2023, the patient received the 3rd dose of Shingrix (left deltoid). On 13-JUL-2023, an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: patient inadvertently received a third dose of Shingrix). The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt date: 13-JUL-2023 The pharmacist reported that a patient inadvertently received a third dose of Shingrix on 13 July 2023. The reporter states that the patient had 2 doses of vaccine before, did not remember at time of injection and received a 3rd dose which led to extra dose administered.  The reporter did not consent to follow up.
In the past, she has had stomach illness within hours of flu shot, but wanted to try a preservative free influenza vaccination. Last flu vaccine was 15 years ago. Approximately 5 to 6 hours after receiving the preservative free influenza vaccination, she stated that her throat felt like a pin cushion (especially on the right side), then she started to feel achy  and had severe chills. She also became emotional. Did not try eating because she felt that she would not be able to keep food down. She was able to keep fluids down.  She was using ibuprofen and did one dose of benadryl. Had a rough night and did not sleep well. She felt tired the next day, but was improving.