chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Headache; fatigue and feeling run down; developed a clicking sensation in her right ear/ persistent like "if you have water in your ear"/ notices it a lot at night/ happens mostly at night but is happening right now; This is a spontaneous report from a contactable consumer (patient herself). A 47-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection (lot number and expiry date unknown) via an unspecified route of administration on 22Dec2020 at a single dose for COVID-19 immunization, also reported as "for work." The patient has no medical history and there were no concomitant medications. The patient received the first dose of the COVID 19 vaccine on 22Dec2020. She was scheduled to receive the second on 12Jan2021, Tuesday. Since receiving the vaccine, the night of receiving it, she developed a clicking sensation in her right ear. It hasn't gone away. It was kind of like "when you have water in your ear." It is not popping like on an airplane. She can trigger it if she hums or makes her vocal cords vibrate. She can make it happen. It is not painful. She notices it a lot at night. It might be a eustachian tube thing. At first, she was wondering if it could be coincidental. She hasn't experience it before though. It could be related to a sinus thing. But she hasn't realized a sinus issue. She thought, by now it would have gone away. No one has looked in her ear though. She works in healthcare. She doesn't have a prescribing doctor. She got the vaccine at work. She noticed the clicking in the middle of night so she can't say an exact time of onset. She thought it might have been improving, but she thinks she is just getting used to it. She is less aware of it now. The patient asked if she should be seen by her HCP or have her ears checked out. She asked if the clicking sound that developed in her ear after getting the first dose of the vaccine was normal? It is persistent like "if you have water in your ear." It happens mostly at night but is happening right now. The patient further reported having the expected side effects of headache, fatigue and feeling run down since an unknown date. The patient has not recovered from the event "developed a clicking sensation in her right ear/ persistent like "if you have water in your ear"/ notices it a lot at night/ happens mostly at night but is happening right now." Outcome of the events "headache" and "fatigue and feeling run down" was unknown.  Information on the lot/batch number has been requested.
Psoriasis aggravated; Condition aggravated; Drug effect decreased; This spontaneous case was reported by a consumer and describes the occurrence of PSORIASIS (Psoriasis aggravated), CONDITION AGGRAVATED (Condition aggravated) and THERAPEUTIC PRODUCT EFFECT DECREASED (Drug effect decreased) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for an unknown indication.    No Medical History information was reported.   On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced PSORIASIS (Psoriasis aggravated), CONDITION AGGRAVATED (Condition aggravated) and THERAPEUTIC PRODUCT EFFECT DECREASED (Drug effect decreased). At the time of the report, PSORIASIS (Psoriasis aggravated), CONDITION AGGRAVATED (Condition aggravated) and THERAPEUTIC PRODUCT EFFECT DECREASED (Drug effect decreased) outcome was unknown.            Concomitant Drugs were not reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Treatment information was not reported.  Company Comment: This is a spontaneous case concerning  an elderly male patient with no reported medical history, who experienced the unexpected non-serious events of Psoriasis, Condition Aggravated and Therapeutic product effect decreased. Temporal association cannot be assessed due to onset of the events was not specified. No further details on clinical course, lab test results and treatment received were reported. Outcome of the events was unknown, at the time of report.. The benefit-risk relationship of mRNA-1273 Vaccine, is not affected by this report.; Sender's Comments: This is a spontaneous case concerning  an elderly male patient with no reported medical history, who experienced the unexpected non-serious events of Psoriasis, Condition Aggravated and Therapeutic product effect decreased. Temporal association cannot be assessed due to onset of the events was not specified. No further details on clinical course, lab test results and treatment received were reported. Outcome of the events was unknown, at the time of report.. The benefit-risk relationship of mRNA-1273 Vaccine, is not affected by this report.
COVID-19; INAPPROPRIATE SCHEDULE OF VACCINE ADMINISTERED; OFF LABEL USE; This spontaneous report received from a patient concerned a 60 year old female of an unspecified race and ethnic origin. The patient was enrolled in a non-company sponsored clinical trial. The patient's height and weight were not reported. The patient's concurrent conditions included moderate to severe rheumatoid arthritis. The patient was previously received with covid-19 vaccine ad26. cov2.s. (dose number in series 1) (suspension for injection, intramuscular, batch number: unknown and expiry: unknown) dose was not reported, 01 total, administered on 30-MAR-2021 for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26. cov2. s. On an unspecified date in 2021, the patient was previously received with covid-19 vaccine ad26. cov2.s. (dose number in series 2) (suspension for injection, intramuscular, batch number: unknown and expiry: unknown) dose was not reported, 01 total, administered for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with second dose of covid-19 vaccine ad26. cov2. s. The patient additionally received covid-19 vaccine ad26.cov2. s (dose number in series 3) (suspension for injection, intramuscular, batch number: Unknown and expiry: unknown) dose was not reported, 01 total, administered on 30-NOV-2021 for prophylactic vaccination which was an off label use as inappropriate schedule of vaccine administered. The batch number was not reported. The company is unable to perform follow-up to request batch/lot number. Non-company suspect drugs included: Humira (adalimumab) (solution for injection in pre-filled pen, subcutaneous, batch number: 1154253 and expiry: unknown) dose, frequency and therapy dates were not reported for moderate to severe rheumatoid arthritis. No concomitant medications were reported.  On 03-JAN-2022, the patient experienced covid-19 (dose number in series 3). Laboratory data included: COVID-19 virus test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from covid-19, and the outcome of inappropriate schedule of vaccine administered and off label use was not reported. This report was non-serious. This report was associated with product quality complaint: 90000211924. The suspected product quality complaint has been confirmed to be the reported allegation could not be determined. A manufacturing related root cause could not be identified based on the PQC evaluation/investigation performed. This case is a duplicate of 20220124494.; Sender's Comments: V0: Medical assessment comments not required as per standard procedure as the case is assessed as non serious.
This spontaneous report as received from a physician (M.D.) refers to a patient of unkonwn age. On an unknown date of "last week" (January 2014) the patient was vaccinated with a dose of VARIVAX (Merck) (dose, route, frequency, injection site and lot# not provided). It was reported that an unspecified patient, of a different unspecified physician within in reporter's practice, was mistakenly administered a dose of VARIVAX (Merck) instead of ZOSTAVAX on an unspecified date "last week" (January 2014). No adverse effect reported. Additional information is not expected.
Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. In or around 09-JAN-2015 the patient was inoculated with ZOSTAVAX for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving, ZOSTAVAX, the patient suffered sudden and total sensorineural hearing loss of the left ear. As a direct and proximate result of ZOSTAVAX vaccine, the patient's symptoms have resulted in physical limitations not present prior to using ZOSTAVAX. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. As a direct and proximate consequence, the patient sustained serious personal injuries and related losses including, but not limited to, the following: a. the patient required and will continue to require healthcare and services; b. The patient incurred and will continue to incur medical and related expenses; and c. The patient suffered and will continue to suffer mental anguish, physical pain and suffering, diminished capacity for the enjoyment of life, a diminished quality of life, and other losses and damages. Sudden and total sensorineural hearing loss of the left ear was considered disabling. Upon internal review sudden and total sensorineural hearing loss of the left ear was considered medically significant. Additional information has been requested.
pt recvd vax;fussy in am;feverish & screaming;had hard time breathing during screaming periods;leg swollen & red;MD seen;pt better at noc but still fussy by am 28jan95;by pm 28jan pt ok;
Had a household member who was ill at home for several days preceding this patient's onset of symptoms; Headaches; Developed symptomatic COVID infection; Developed symptomatic COVID infection; This is a spontaneous report from a contactable other hcp. A 61-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EK9231; Expiry date Unknown), dose 2 via intramuscular route of administration, administered in Deltoid Left on 14Jan2021 as 2ND DOSE, SINGLE for covid-19 immunisation. The patient had received first dose of PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EH9899; Expiry date Unknown) dose 1 via intramuscular route of administration, administered in Deltoid Left on 22Dec2020 as 1ST DOSE, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. From an unknown date, the patient had a household member who was ill at home for several days preceding this patient's onset of symptoms in Apr2021. The household member was tested positive for COVID 19. On 07Apr2021, (at the age of 61-year-old) the patient developed symptomatic covid infection. The patient had headaches throughout the course of illness, for which the patient responded to OTC pain reliever. On 08Apr2021 and 09Apr2021, the patient underwent Test for SARS-CoV-2 by PCR, which was revealed to be positive. Therapeutic measures were taken as a result of headaches. The outcome of the event symptomatic COVID infection was recovered. The outcome of the events vaccination failure, exposure to SARS-Cov-2 and headache was unknown.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events vaccination failure and covid-19 and the suspect drug BNT162B2.
Narrative:  Patient received two doses of covid vaccine. PHM includes CAD, HTN, macrocytic anemia, CKD, OA requiring steroids who presented with 6 weeks of diarrhea. Upon admission, was found to have necrotizing fascitis of RLE and subsequently decompensated. Patient coded and was not able to survive. Reporting per Regulatory Authority instructions.
I am a chronic migraine sufferer for 40+ years.  The day after my 2nd Pfizer was 16 hours of PURE MIGRAINE HELL.  I was so nauseous from the HEAD PAIN that I could not take water or an Excedrin until 16 hours after it all began.   The following days were progressively better, but my head did not feel normal until 6 days after the 2nd shot.
Baby screamed a high pitched cry for 2.5 hours and was inconsolable. Leg swelled from hip to thigh and turned red on the side of the injection site. Low grade fever of 99.8.
HEADACHE; PLUGGED EARS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose, start therapy date and vaccination site were not reported for covid-19 prevention. No concomitant medications were reported.  On an unspecified date, the patient experienced headache, and plugged ears. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache and plugged ears was not reported. This report was non-serious.
Severe chills, low grade fever (101F), joint aches, headache, nasal congestion  Symptoms lasted about12 hrs. Treatment was OTC acetaminophen and prescription Sumatriptan
Patient reported whole body tingling. Stated he has never felt this way after a vaccine. Patient was very calm, reasonable, and a trustworthy reported of an AE based on my interaction. Patient reported slight chills and flu like feeling. Patient says palms and soles of feet itch. Patient has been taking ZYRTEC to help relieve these symptoms and says symptoms are not getting worse, but better with time. We are 5 days post immunization and patient still has symptoms but is getting better.
rash; swelling of lymph node; This spontaneous case was reported by an other health care professional and describes the occurrence of RASH (rash) and LYMPHADENOPATHY (swelling of lymph node) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 031B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RASH (rash) and LYMPHADENOPATHY (swelling of lymph node). At the time of the report, RASH (rash) outcome was unknown and LYMPHADENOPATHY (swelling of lymph node) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug information was provided by reporter.  No treatment drug information was provided by reporter.   This case was linked to MOD-2021-063924 (Patient Link).
patient received dose of Moderna vaccine post excursion; patient received dose of Moderna vaccine post excursion; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patient received dose of Moderna vaccine post excursion), POOR QUALITY PRODUCT ADMINISTERED (patient received dose of Moderna vaccine post excursion) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patient received dose of Moderna vaccine post excursion), POOR QUALITY PRODUCT ADMINISTERED (patient received dose of Moderna vaccine post excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patient received dose of Moderna vaccine post excursion), POOR QUALITY PRODUCT ADMINISTERED (patient received dose of Moderna vaccine post excursion) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (patient received dose of Moderna vaccine post excursion) and POOR QUALITY PRODUCT ADMINISTERED (patient received dose of Moderna vaccine post excursion).    This case contains information for the 08th out of 19 patients described by the reporter  Concomitant medication was not provided.  Treatment medication information was not provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-706941, US-MODERNATX, INC.-MOD-2023-706966 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-706941:Patient 1 of 19 (Master case) US-MODERNATX, INC.-MOD-2023-706966:Patient 8 of 19
Always tired, shortness of breath (waking in middle of the night unable to catch breath), bad anxiety with problems sleeping, mental fogginess, vision not as clear, dizziness, and irregular ekg.  Seeing a cardiologist on August 26, 2021
11/19 I had a bad sinus headache w/congestion. Nothing of my usual OTC methods was working (steam, Sudafed, Xlear nasal rinse) and called my nurse and saw her in her office. Confirmed a possible infection and issued Azithromycin for 10 days. Cleared infection and is currently on the mend.
HISTORY: EE presents to the EHO  ALLERGIC TO COCONUTS, LOBSTER AND RUM.-swelling of throat --- carries an epi pen. Reaction 2012 OCT 10 to flu vaccine: red eyes, coughing, congestion and low grade fever (101.9). In 2011, temp was 101.2 with the same reaction. Treated with ibuprofen (800 mg X 1 dose) and Claritin (10mg q day) X 2 days. 10-11-12 Skin of the orbits of eyes are pinker than the surrounding facial tissue, eyes are watery in appearance and reddened. EE is fair skinned normally.
This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. 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: 213D21A expiry: 01-JUN-2022) dose was not reported, administered on right deltoid on 29-DEC-2021 for prophylactic vaccination. No concomitant medications were reported. On 29-DEC-2021, the patient experienced vaccine given 12-24 hours after the 6 hour window was still good (incorrectly stored vaccine administered), out of specification product use, and off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine given 12-24 hours after the 6 hour window was still good (incorrectly stored vaccine administered), out of specification product use and off label use was not reported. This report was non-serious.
April 19 1:05pm: Slight soreness at sight of injection. April 19 5:00pm: Intense soreness at sight of injection. April 19 10:00pm: Intense soreness at sight of injection. Intense ache in whole arm where injection was placed. Mild whole body ache. April 20 7:00am: Intense soreness at sight of injection. Medium ache in whole arm of injection. April 20 12:00pm: Intense soreness at sight of injection. Medium ache in whole arm of injection. Fatigue. Mild headache.  April 20 7:00pm:  Mild soreness at sight of injection.  Note: My menstrual period started at this time. The typical symptoms associated with my period are fatigue and mild headache. April 20 9:00pm: No soreness at sight of infection. A non-painful pimple like sack forms on my gums. This has never happened to me before. April 20 10:00pm: More blood and puss fill the pimple like sack. April 20 10:30pm: Puss filled sack pops and empties quickly. It quickly scabs over. April 21 7:00am: Area where sack is mostly healed. No more symptoms.
Pfizer-BioNTech COVID-19 Vaccine EUA given approximately 11:30 a.m. 8/4/21 in the left arm. Patient vomited repeatedly from around 10 p.m. to 11 p.m. 8/4/21. The next morning 8/5/21, patient had swollen lymph nodes under left side of jaw (same side as vaccine administered) that lasted several hours. By 8/6/21, no adverse effects present.
This spontaneous report as received from physician via field representative refers to a 60 years old female patient. On 11-NOV-2013, the patient was vaccinated with ZOSTAVAX 19400 plaque units (PFU) (strength, dose, frequency and route of administration were not provided) for age. No concomitant medications were reported. On 12-NOV-2013, the patient developed a shingles like rash around the injection site where ZOSTAVAX was administered and a red welt around the injection site. Physician reported the patient had streaking and associated redness. Patient sought medical attention due to office visit. Unspecified antihistamine, doxycycline was given for adverse events. No product quality complaint (PQC) was involved. On 19-NOV-2013, the outcome of events was resolved. Causality was not reported. VZV (Varicella zoster virus) packet was mailed. No further information provided. Additional information has been requested.
felt like the flu; Muscle pains; Headache; Shivering and chills; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 71-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th December 2019, the patient received the 1st dose of Shingrix. On 17th December 2019, 8 hrs after receiving Shingrix, the patient experienced influenza-like symptoms, muscle pain, headache and chills. On 20th December 2019, the outcome of the influenza-like symptoms, muscle pain, headache and chills were recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms, muscle pain, headache and chills to be related to Shingrix.  Additional details were reported as follows: This case was reported by patient itself. The patient received vaccine and had influenza-like symptoms, muscle pain, headache, shivering and chills. The patient wanted to know whether it will happened again after receiving 2nd dose. No other information was reported.